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Code · REGISTER · 2008-02-06 · Federal Aviation Administration (FAA), Department of Transportation (DOT) · Rules and Regulations

Rules and Regulations. Final rule; request for comments

77,034 words·~350 min read·/register/2008/02/06/08-497

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BILLING CODE 3410-02-P DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2007-27824; Directorate Identifier 2003-NE-12-AD; Amendment 39-15364; AD 2006-11-05R2] RIN 2120-AA64 Airworthiness Directives; Rolls-Royce plc RB211 Series Turbofan Engines AGENCY: Federal Aviation Administration (FAA), Department of Transportation (DOT). ACTION: Final rule; request for comments. SUMMARY: The FAA is revising an existing airworthiness directive
(AD)for Rolls-Royce plc
(RR)RB211-22B series, RB211-524B, -524C2, -524D4, -524G2, -524G3, and -524H series, and RB211-535C and -535E series turbofan engines with high pressure compressor
(HPC)stage 3 disc assemblies, part numbers (P/Ns) LK46210, LK58278, LK67634, LK76036, UL11706, UL15358, UL22577, UL22578, and UL24738 installed. That AD currently requires removing from service certain disc assemblies before they reach their full published life if not modified with anticorrosion protection. This AD requires the same actions but relaxes the removal compliance time for certain disc assemblies that have a record of detailed inspection. This AD results from the FAA allowing certain affected disc assemblies that have a record of a detailed inspection, to remain in service for a longer period than the previous AD allowed. We are issuing this AD to relax the compliance time for disc assemblies manufactured both “before and after 1990” by providing an option to track the disc life based on a record of a detailed inspection rather than by its entry into service date, while continuing to prevent corrosion-induced uncontained disc assembly failure, resulting in damage to the airplane. DATES: Effective February 21, 2008. The Director of the Federal Register previously approved the incorporation by reference of certain publications listed in the regulations as of February 24, 2004 (69 FR 2661, January 20, 2004). We must receive any comments on this AD by April 7, 2008. ADDRESSES: Use one of the following addresses to comment on this AD. • *Federal eRulemaking Portal:* Go to *http://www.regulations.gov* and follow the instructions for sending your comments electronically. • *Mail:* U.S. Docket Management Facility, Department of Transportation, 1200 New Jersey Avenue SE., West Building Ground Floor, Room W12-140, Washington, DC 20590-0001. • *Hand Delivery:* Deliver to Mail address above between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. • *Fax:*
(202)493-2251. Contact Rolls-Royce plc, PO Box 31, Derby, England, DE248BJ; telephone: 011-44-1332-242424; fax: 011-44-1332-245-418, for the service information identified in this AD. FOR FURTHER INFORMATION CONTACT: Ian Dargin, Aerospace Engineer, Engine Certification Office, FAA, Engine and Propeller Directorate, 12 New England Executive Park; Burlington, MA 01803; e-mail: *ian.dargin@faa.gov* ; telephone
(781)238-7178; fax
(781)238-7199. SUPPLEMENTARY INFORMATION: On May 15, 2006, the FAA issued AD 2006-11-05, Amendment 39-14609 (71 FR 29586, May 23, 2006). We also issued a correction to that AD on September 26, 2006 (71 FR 58254, October 3, 2006) and a revision to that AD on April 9, 2007 (72 FR 18862, April 16, 2007). That AD revision requires removing from service certain disc assemblies before they reach their full published life if not modified with anticorrosion protection. That AD was the result of the manufacturer's reassessment of the corrosion risk on HPC stage 3 disc assemblies that have not yet been modified with sufficient application of anticorrosion protection. That condition, if not corrected, could result in corrosion-induced uncontained disc assembly failure, resulting in damage to the airplane. Actions Since AD 2006-11-05R1 Was Issued Since AD 2006-11-05R1 was issued, we discovered that the population of affected disc assemblies identified in that AD was incorrect. That AD allowed affected disc assemblies that entered into service “before 1990” that have a record of a detailed inspection, to remain in service for a longer period than the previous AD, AD 2006-11-05, allowed. This revised AD allows disc assemblies manufactured both “before and after 1990” that have a record of a detailed inspection, to remain in service for 17 years from last overhaul inspection date. But the discs are not to exceed the manufacturer's published cyclic limit in the time limits section of the manual. We are issuing this AD to relax the compliance time for certain disc assemblies by providing an option to track the disk life based on a record of a detailed inspection rather than by its entry into service date, while continuing to prevent corrosion-induced uncontained disc assembly failure, resulting in damage to the airplane. Relevant Service Information We have reviewed and approved the technical contents of RR MSB No. RB.211-72-9661, Revision 5, dated December 22, 2006. That MSB allows affected disc assemblies and that have a record of detailed inspection: • To remain in service for 17 years from last overhaul inspection date; but • Not to exceed the manufacturer's published cyclic limit in the time limits section of the manual. We do not incorporate by reference this MSB, but we list it in the Related Information section. Bilateral Airworthiness Agreement This engine model is manufactured in the United Kingdom (UK), and is type certificated for operation in the United States under the provisions of section 21.29 of the Federal Aviation Regulations (14 CFR 21.29) and the applicable bilateral airworthiness agreement. Under this bilateral airworthiness agreement, the Civil Aviation Authority (CAA), which is the airworthiness authority for the UK, has kept the FAA informed of the situation described above. We have examined the findings of the CAA, reviewed all available information, and determined that AD action is necessary for products of this type design that are certificated for operation in the United States. FAA's Determination and Requirements of This AD The unsafe condition described previously is likely to exist or develop on other RR RB211-22B series, RB211-524B, -524C2, -524D4, -524G2, -524G3, and -524H series, and RB211-535C and -535E series turbofan engines of the same type design. We are issuing this AD to relax the compliance time for certain disc assemblies by providing an option to track the disk life based on a record of a detailed inspection rather than by its entry into service date, while continuing to prevent corrosion-induced uncontained disc assembly failure, resulting in damage to the airplane. This AD requires the following for affected HPC stage 3 rotor disc assemblies: • Removing affected disc assemblies from service; and • Re-machining, inspecting, and applying anticorrosion protection; and • Re-marking, and returning disc assemblies into service; and • Allowing affected disc assemblies that have a record of a detailed inspection, to remain in service for 17 years from last overhaul inspection date but not to exceed the manufacturer's published cyclic limit in the time limits section of the manual. FAA's Determination of the Effective Date Since an unsafe condition exists that requires the immediate adoption of this AD, we have found that notice and opportunity for public comment before issuing this AD are impracticable. Good cause exists for making this amendment effective in less than 30 days. Comments Invited This AD is a final rule that involves requirements affecting flight safety and was not preceded by notice and an opportunity for public comment. However, we invite you to send us any written relevant data, views, or arguments regarding this AD. Send your comments to an address listed under ADDRESSES . Include “AD Docket No. FAA-2007-27824; Directorate Identifier 2003-NE-12-AD” in the subject line of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of the rule that might suggest a need to modify it. We will post all comments we receive, without change, to *http://www.regulations.gov,* including any personal information you provide. We will also post a report summarizing each substantive verbal contact with FAA personnel concerning this AD. Using the search function of the Web site, anyone can find and read the comments in any of our dockets, including the name of the individual who sent the comment (or signed the comment on behalf of an association, business, labor union, etc). You may review the DOT's complete Privacy Act Statement in the **Federal Register** published on April 11, 2000 (65 FR 19477-78). Examining the AD Docket You may examine the AD docket on the Internet at *http://www.regulations.gov;* or in person at the Docket Operations office between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this AD, the regulatory evaluation, any comments received, and other information. The street address for the Docket Operations office (telephone
(800)647-5527) is the same as the Mail address provided in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt. Authority for This Rulemaking Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, Section 106, describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the Agency's authority. We are issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701, “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action. Regulatory Findings We have determined that this AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government. For the reasons discussed above, I certify that this AD: 1. Is not a “significant regulatory action” under Executive Order 12866; 2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and 3. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. We prepared a summary of the costs to comply with this AD and placed it in the AD Docket. You may get a copy of this summary at the address listed under ADDRESSES . List of Subjects in 14 CFR Part 39 Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety. Adoption of the Amendment Under the authority delegated to me by the Administrator, the Federal Aviation Administration amends part 39 of the Federal Aviation Regulations (14 CFR part 39) as follows: PART 39—AIRWORTHINESS DIRECTIVES 1. The authority citation for part 39 continues to read as follows: Authority: 49 U.S.C. 106(g), 40113, 44701. § 39.13 [Amended] 2. The FAA amends § 39.13 by removing Amendment 39-15026 (72 FR 18862, April 16, 2007) and by adding a new airworthiness directive, Amendment 39-15364, to read as follows: **2006-11-05R2 Rolls-Royce plc:** Amendment 39-15364. Docket No. FAA-2007-27824; Directorate Identifier 2003-NE-12-AD. Effective Date
(a)This airworthiness directive
(AD)becomes effective February 21, 2008. Affected ADs
(b)This AD revises AD 2006-11-05R1, Amendment 39-15026. Applicability
(c)This AD applies to Rolls-Royce plc
(RR)RB211-22B series, RB211-524B, -524C2, -524D4, -524G2, -524G3, and -524H series, and RB211-535C and -535E series turbofan engines with high pressure compressor
(HPC)stage 3 disc assemblies, part numbers (P/Ns) LK46210, LK58278, LK67634, LK76036, UL11706, UL15358, UL22577, UL22578, and UL24738 installed. These engines are installed on, but not limited to, Boeing 747, Boeing 757, Boeing 767, Lockheed L-1011, and Tupolev Tu204 series airplanes. Unsafe Condition
(d)This AD results from the FAA allowing certain affected disc assemblies that have a record of a detailed inspection, to remain in service for a longer period than the previous AD allowed. We are issuing this AD to relax the compliance time for disc assemblies manufactured both “ before and after 1990” by providing an option to track the disc life based on a record of a detailed inspection rather than by its entry into service date, while continuing to prevent corrosion-induced uncontained disc assembly failure, resulting in damage to the airplane. Compliance
(e)You are responsible for having the actions required by this AD performed within the compliance times specified unless the actions have already been done. Removal of HPC Stage 3 Disc Assemblies
(f)Remove from service affected HPC stage 3 disc assemblies identified in the following Table 1, using one of the following criteria: Table 1.—Affected HPC Stage 3 Disc Assemblies Engine model Rework band for cyclic life accumulated on disc assemblies P/Ns LK46210 and LK58278 (pre RR Service Bulletin
(SB)No. RB.211-72-5420) Rework band for cyclic life accumulated on disc assembly P/N LK67634 (pre RR SB No. RB.211-72-5420) Rework band for cyclic life accumulated on disc assemblies P/Ns LK76036, UL11706, UL15358, UL22577, UL22578, and UL24738 (pre RR SB No. RB.211-72-9434) -22B series 4,000-6,200 7,000-10,000 11,500-14,000 -535E4 series N/A N/A 9,000-15,000 -524B-02, B-B-02, B3-02, and B4 series, Pre and Post accomplishment of SB No. 72-7730 4,000-6,000 7,000-9,000 11,500-14,000 -524B2 and C2 series, Pre SB No. 72-7730 4,000-6,000 7,000-9,000 11,500-14,000 -524B2-B-19 and C2-B-19 series, SB No. 72-7730 4,000-6,000 7,000-9,000 8,500-11,000 -524D4 series, Pre SB No. 72-7730 4,000-6,000 7,000-9,000 11,500-14,000 -524D4-B series, SB No. 72-7730 4,000-6,000 7,000-9,000 8,500-11,000 -524G2, G3, H, and H2 series 4,000-6,000 7,000-9,000 8,500-11,000
(1)For disc assemblies that entered into service before 1990, remove disc assembly and rework as specified in paragraph (g)(2) of this AD, on or before January 4, 2007, but not to exceed the upper cyclic limit in Table 1 of this AD before rework. Disc assemblies reworked may not exceed the manufacturer's published cyclic limit in the time limits section of the manual.
(2)For disc assemblies that entered into service in 1990 or later, remove disc assembly within the cyclic life rework bands in Table 1 of this AD, or within 17 years after the date of the disc assembly entering into service, whichever is sooner, but not to exceed the upper cyclic limit of Table 1 of this AD before rework. Disc assemblies reworked may not exceed the manufacturer's published cyclic limit in the time limits section of the manual.
(3)For disc assemblies that when new, were modified with an application of anticorrosion protection and re-marked to P/N LK76036 (not previously machined) as specified by part 1 of the original issue of RR SB No. RB.211-72-5420, dated April 20, 1979, remove RB211-22B series disc assemblies before accumulating 10,000 cycles-in-service (CIS), and remove RB211-524 series disc assemblies before accumulating 9,000 CIS.
(4)If the disc assembly date of entry into service cannot be determined, the date of disc assembly manufacture may be obtained from RR and used instead.
(5)Disc assemblies in RB211-535C series operation are unaffected by the interim rework cyclic band limits in Table 1 of this AD, but must meet the calendar life requirements of either paragraph (f)(1) or (f)(2) of this AD, as applicable. Optional Rework of HPC Stage 3 Disc Assemblies
(g)Rework HPC stage 3 disc assemblies that were removed in paragraph
(f)of this AD as follows:
(1)For disc assemblies that when new, were modified with an application of anticorrosion protection and re-marked to P/N LK76036 (not previously machined) as specified by Part 1 of the original issue of RR SB RB.211-72-5420, dated April 20, 1979, rework disc assemblies and re-mark to either P/N LK76034 or P/N LK78814 using paragraph 2.B. of the Accomplishment Instructions of RR SB No. RB.211-72-5420, Revision 4, dated February 29, 1980. This rework constitutes terminating action to the removal requirements in paragraph
(f)of this AD.
(2)For all other disc assemblies, rework using Paragraph 3.B. of the Accomplishment Instructions of RR SB No. RB.211-72-9434, Revision 4, dated January 12, 2000. This rework constitutes terminating action to the removal requirements in paragraph
(f)of this AD.
(3)If rework is done on disc assemblies that are removed before the disc assembly reaches the lower life of the cyclic life rework band in Table 1 of this AD, artificial aging of the disc assembly to the lower life of the rework band, at time of rework, is required.
(4)Disc assemblies that have a record of detailed inspection, regardless of the date of entry into service, are allowed to remain in service for 17 years from last overhaul inspection date but not to exceed the manufacturer's published cyclic limit in the time limits section of the manual. Alternative Methods of Compliance
(h)The Manager, Engine Certification Office, has the authority to approve alternative methods of compliance for this AD if requested using the procedures found in 14 CFR 39.19. Related Information
(i)Civil Aviation Authority AD 004-01-94, dated January 4, 2002, and RR Mandatory Service Bulletin No. RB.211-72-9661, Revision 5, dated December 22, 2006, pertain to the subject of this AD. Material Incorporated by Reference
(j)You must use Rolls-Royce plc Service Bulletin No. RB.211-72-5420, Revision 4, dated February 29, 1980, and Rolls-Royce plc Service Bulletin No. RB.211-72-9434, Revision 4, dated January 12, 2000, to perform the rework required by this AD. The Director of the Federal Register previously approved the incorporation by reference of these service bulletins in accordance with 5 U.S.C. 552(a) and 1 CFR part 51, as of February 24, 2004 (69 FR 2661, January 20, 2004). You can get copies from Rolls-Royce plc, PO Box 31, Derby, England, DE248BJ; telephone: 011-44-1332-242424; fax: 011-44-1332-245-418. You can review copies at the FAA, New England Region, 12 New England Executive Park, Burlington, MA; or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: *http://www.archives.gov/federal-register/cfr/ibr-locations.html* .
(k)Contact Ian Dargin, Aerospace Engineer, Engine Certification Office, FAA, Engine and Propeller Directorate, 12 New England Executive Park; Burlington, MA 01803; e-mail: *ian.dargin@faa.gov;* telephone
(781)238-7178; fax
(781)238-7199, for more information about this AD. Issued in Burlington, Massachusetts, on January 25, 2008. Peter A. White, Assistant Manager, Engine and Propeller Directorate, Aircraft Certification Service. [FR Doc. E8-2028 Filed 2-5-08; 8:45 am] BILLING CODE 4910-13-P DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 97 [Docket No. 30592; Amdt. No. 3255] Standard Instrument Approach Procedures; Miscellaneous Amendments AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Final rule. SUMMARY: This rule amends Standard Instrument Approach Procedures (SIAPs) for operations at certain airports. These regulatory actions are needed because of changes in the National Airspace System, such as the commissioning of new navigational facilities, adding of new obstacles, or changing air traffic requirements. These changes are designed to provide safe and efficient use of the navigable airspace and to promote safe flight operations under instrument flight rules at the affected airports. DATES: This rule is effective February 6, 2008. The compliance date for each SIAP is specified in the amendatory provisions. The incorporation by reference of certain publications listed in the regulations is approved by the Director of the Federal Register as of February 6, 2008. ADDRESSES: Availability of matter incorporated by reference in the amendment is as follows: *For Examination—* 1. FAA Rules Docket, FAA Headquarters Building, 800 Independence Avenue, SW., Washington, DC 20591; 2. The FAA Regional Office of the region in which the affected airport is located; 3. The National Flight Procedures Office, 6500 South MacArthur Blvd., Oklahoma City, OK 73169 or, 4. The National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: *http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.* *Availability* —All SIAPs are available online free of charge. Visit *nfdc.faa.gov* to register. Additionally, individual SIAP and Takeoff Minimums and ODP copies may be obtained from: 1. FAA Public Inquiry Center (APA-200), FAA Headquarters Building, 800 Independence Avenue, SW., Washington, DC 20591; or 2. The FAA Regional Office of the region in which the affected airport is located. FOR FURTHER INFORMATION CONTACT: Harry J. Hodges, Flight Procedure Standards Branch (AFS-420), Flight Technologies and Programs Division, Flight Standards Service, Federal Aviation Administration, Mike Monroney Aeronautical Center, 6500 South MacArthur Blvd., Oklahoma City, OK 73169 ( *Mail Address:* P.O. Box 25082 Oklahoma City, OK 73125) *telephone:*
(405)954-4164. SUPPLEMENTARY INFORMATION: This rule amends Title 14, Code of Federal Regulations, Part 97 (14 CFR part 97) by amending the referenced SIAPs. The complete regulatory description of each SIAP is listed on the appropriate FAA Form 8260, as modified by the National Flight Data Center (FDC)/Permanent Notice to Airmen (P-NOTAM), and is incorporated by reference in the amendment under 5 U.S.C. 552(a), 1 CFR part 51, and § 97.20 of Title 14 of the Code of Federal Regulations. The large number of SIAPs, their complex nature, and the need for a special format make their verbatim publication in the **Federal Register** expensive and impractical. Further, airmen do not use the regulatory text of the SIAPs, but refer to their graphic depiction on charts printed by publishers of aeronautical materials. Thus, the advantages of incorporation by reference are realized and publication of the complete description of each SIAP contained in FAA form documents is unnecessary. This amendment provides the affected CFR sections and specifies the types of SIAP and the corresponding effective dates. This amendment also identifies the airport and its location, the procedure and the amendment number. The Rule This amendment to 14 CFR part 97 is effective upon publication of each separate SIAP as amended in the transmittal. For safety and timeliness of change considerations, this amendment incorporates only specific changes contained for each SIAP as modified by FDC/P-NOTAMs. The SIAPs, as modified by FDC P-NOTAM, and contained in this amendment are based on the criteria contained in the U.S. Standard for Terminal Instrument Procedures (TERPS). In developing these changes to SIAPs, the TERPS criteria were applied only to specific conditions existing at the affected airports. All SIAP amendments in this rule have been previously issued by the FAA in a FDC NOTAM as an emergency action of immediate flight safety relating directly to published aeronautical charts. The circumstances which created the need for all these SIAP amendments requires making them effective in less than 30 days. Because of the close and immediate relationship between these SIAPs and safety in air commerce, I find that notice and public procedure before adopting these SIAPs are impracticable and contrary to the public interest and, where applicable, that good cause exists for making these SIAPs effective in less than 30 days. Conclusion The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore-(1) is not a “significant regulatory action” under Executive Order 12866;
(2)is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and
(3)does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. For the same reason, the FAA certifies that this amendment will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. List of Subjects in 14 CFR Part 97 Air Traffic Control, Airports, Incorporation by reference, and Navigation (Air). Issued in Washington, DC, on January 25, 2008. James J. Ballough, Director, Flight Standards Service. Adoption of the Amendment Accordingly, pursuant to the authority delegated to me, Title 14, Code of Federal regulations, Part 97, 14 CFR part 97, is amended by amending Standard Instrument Approach Procedures, effective at 0901 UTC on the dates specified, as follows: PART 97—STANDARD INSTRUMENT APPROACH PROCEDURES 1. The authority citation for part 97 continues to read as follows: Authority: 49 U.S.C. 106(g), 40103, 40106, 40113, 40114, 40120, 44502, 44514, 44701, 44719, 44721-44722. 2. Part 97 is amended to read as follows: §§ 97.23, 97.25, 97.27, 97.29, 97.31, 97.33, 97.35 [Amended] By amending: § 97.23 VOR, VOR/DME, VOR or TACAN, and VOR/DME or TACAN; § 97.25 LOC, LOC/DME, LDA, LDA/DME, SDF, SDF/DME; § 97.27 NDB, NDB/DME; 97.29 ILS, ILS/DME,ISMLS, MLS/DME, MSL/RNAV; § 97.31 RADAR SIAPs; § 97.33 RNAV SIAPs; and § 97.35 COPTER SIAPs, Identified as follows: * * * Effective Upon Publication FDC date State City Airport FDC No. Subject 01/18/08 AL REFORM NORTH PICKENS 8/1712 RNAV
(GPS)RWY 19, ORIG. [FR Doc. E8-2005 Filed 2-5-08; 8:45 am] BILLING CODE 4910-13-P CONSUMER PRODUCT SAFETY COMMISSION 16 CFR Part 1633 Final Rule: Standard for the Flammability (Open Flame) of Mattress Sets; Correction AGENCY: Consumer Product Safety Commission. ACTION: Correcting amendment. SUMMARY: The Consumer Product Safety Commission (“Commission”) is making corrections to the flammability standard for mattress sets that was published in the **Federal Register** of March 15, 2006, (71 FR 13472). The corrections rectify typographical errors, clarify technical aspects of running the flammability test required by the standard, and clarify that the certification statement on the mattress set label may appear in another language in addition to English. DATES: The corrections become effective on February 6, 2008. FOR FURTHER INFORMATION CONTACT: Heather Sonabend, Office of Compliance, Consumer Product Safety Commission, 4330 East West Highway, Bethesda, MD 20814; telephone
(301)504-7615; e-mail *hsonabend@cpsc.gov.* SUPPLEMENTARY INFORMATION: On March 15, 2006, the Commission issued a final rule specifying a flammability standard to reduce deaths and injuries related to mattress fires. The standard contains requirements for a test procedure, recordkeeping and labeling. Other than the correction that allows translation of the certification statement, the corrections occur in section 1633.7, the provisions describing the technical details of running the flammability test. The changes are described below. In § 1633.7(a)(4), the term “bed frame” is changed to “test frame” to clarify that this refers to the frame used in the test, not a regular bed frame. This change is made in other paragraphs as well. Language also is added to this section to clarify that the angle iron should be positioned to angle down rather than up. In § 1633.7(a)(6), a new paragraph
(v)is created to clarify that the second half of existing paragraph
(iv)relates to the burner inlet line. The remaining subparagraphs are redesignated. A technical error in footnote 1 is corrected to provide the correct measurements for the plastic tubing attaching the metal arms to the gas control. In the paragraph on the flow control system, there was a technical error in the propane pressure value. 70 kPa should be 140 kPa, and 140kPa (20 psig) should be 140 ± 5 kPa (20 ± 1 psig). These measurements and an erroneous reference to a figure 8 are corrected. In § 1633.7(b)(1)(ii) the range used for the propane tank is corrected from 20 ± .5 psig to 20 ± 1 psig. In § 1633.7(d) concerning test preparation a typographical error is corrected to state that the horizontal air flow velocity adjacent to the test specimen shall be no more than 0.5 m/s. A few sentences in subparagraph
(2)are changed to clarify placement of the mattress and foundation specimen on the test frame. In § 1633.7(e) a reference is corrected to correspond to the appropriate redesignated paragraph in § 1633.7(a)(6). In § 1633.7(f) the sentence concerning the general layout for the room configuration is moved to the beginning of the paragraph to make the paragraph easier to follow. In § 1633.7(h) an erroneous reference to figure 8 in subparagraph (1)(iv) is removed. Language is also added in that subparagraph to permit use of a platen that is another dimension than specified if it meets the requirements for a specific sample. In subparagraph (2)(i) rather than specifying an 8 inch length of duct tape to hold the platen in position, the language is changed to clarify that the duct tape be of sufficient length to assure that the platen stays firmly against the mattress surfaces. In subparagraph (2)(iv) language is added to clarify the use of flat stock to assure that the burner is parallel to the mattress surface. In subparagraph (2)(viii) the change clarifies that the stand off foot referred to is that of the vertical burner. The placement of footnote 9 is moved to the last sentence of this subparagraph for clarification. In § 1633.7(i) the abbreviation “ca.” is changed to the word “approximately” for clarification. In § 1633.12 concerning labeling, paragraph (a)(6)(iii) is corrected to make that paragraph concerning mattresses intended to be sold both alone and with a foundation consistent with paragraph (a)(6)(ii) concerning mattresses intended to be sold with a foundation. Also in § 1633.12, paragraph
(d)is corrected to make clear that translation of the certification statement into another language on the reverse side of the required label is permitted. Because these are technical corrections rather than substantive changes, notice and comment is not necessary. See 5 U.S.C. 553(b)(3)(B). The corrections clarify technical aspects of the flammability testing and labeling provisions. They do not change the substantive obligations of mattress manufacturers and importers. For the same reason, there is no need to delay the effective date for these corrections. Id. 553(d)(3). List of Subjects in 16 CFR Part 1633 Consumer protection, Flammable materials, Labeling, Mattresses and mattress pads, Records, Textiles, Warranties. Accordingly, 16 CFR part 1633 is corrected by making the following correcting amendment: PART 1633—STANDARD FOR THE FLAMMABILITY (OPEN FLAME) OF MATTRESS SETS 1. The authority for part 1633 continues to read as follows: Authority: 15 U.S.C. 1193, 1194. 2. Section 1633.7 is amended as follows: a. In paragraph (a)(4)(i) at the end of the first sentence add the words “with a flat surface and no edges extending up from the surface (i.e., the angle is configured down)”; in the second sentence remove the word “bed” and add the word “test”. b. In paragraph (a)(4)(ii), second sentence, before the word “frame” add the word “test”. c. In paragraph (a)(4)(iii) at the beginning and at the end of the first sentence add the word “test” before the word “frame”. d. Redesignate paragraphs (a)(6)(v) through (a)(6)(ix) as paragraphs (a)(6)(vi) through (a)(6)(x) respectively; redesignate the fourth through the last sentence of paragraph (a)6)(iv) as paragraph (a)(6)(v); and add the heading “ *Burner inlet lines.* ” to newly designated paragraph (a)(6)(v). e. In redesignated paragraph (a)(6)(vi) before the word “ *Frame* ” in the heading of the paragraph add the word “ *Burner* ”. f. In redesignated paragraph (a)(6)(vii) in footnote 1 remove the phrase “3 inch ID by inch OD” and add in its place the phrase “0.25 inch ID by 0.4 inch OD”. g. In redesignated paragraph (a)(6)(ix), second sentence, remove the number “70” and in its place add “140 ± 5”; after the number “20” add “± 1”; after the word “Figure” remove the number “8” and add the number “7” in its place. h. In paragraph (b)(1)(ii), the last sentence, remove “20 ± .5” and in its place add “20 ± 1”. i. In paragraph (d)(1), first sentence, before “0.5 m/s” add the words “no more than”. j. In paragraph (d)(2), third sentence, remove the word “bed” and add in its place the word “test”; remove the fourth sentence and add in its place “Carefully center the foundation on top of the test frame to eliminate any gaps between the bottom periphery of the foundation and the inside edges of the test frame. If the mattress is to be tested alone, place it similarly. A mattress tested with its foundation should be centered longitudinally and laterally on the foundation.”. k. In paragraph
(e)remove the number “(ix)” and add in its place the number “(x)”. l. In paragraph
(f)move the third sentence so that it becomes the first sentence of the paragraph. m. In paragraph (h)(1)(iv) add at the end of the first sentence the words “or another dimension that meets the requirements for a specific sample”; remove the last sentence of the paragraph. n. In paragraph (h)(2)(i) remove the last sentence and add it in its place the words “Use a sufficient length of duct tape (platen to mattress top) to assure that the platen stays firmly against the surfaces of the mattress.”. o. In paragraph (h)(2)(iv) remove the first sentence and add in its place the sentence “Make the horizontal burner parallel to the top of the platen (within 3 mm ( 1/8 inch) over the burner tube length); when properly parallel, it should not be possible to insert the 3 mm flat stock under either burner end by bending the copper tube section appropriately.”. p. In paragraph (h)(2)(viii), first sentence, remove the word “its” and add in its place the words “the vertical burner”; move the reference to footnote 9 to the end of the second to last sentence in the paragraph. q. In paragraph (i)(2)(i) in the second to last sentence remove the abbreviation “ca.” and add in its place the word “approximately”. 3. Section 1633.12 is amended as follows: a. In paragraph (a)(6)(iii) before “; and” add the sentence “Such foundation(s) shall be clearly identified by a simple and distinct name and/or number on the mattress label”. b. In paragraph
(d)after the word “paragraphs” remove the phrase “(a)(7)(i) and (a)(7)(ii), and (a)(7)(iii)” and add in their place the phrase “(a)(6)(i) through
(iii)and (a)(7)(i) through (iii)”. Dated: January 30, 2008. Todd Stevenson, Secretary, Consumer Product Safety Commission. [FR Doc. E8-2027 Filed 2-5-08; 8:45 am] BILLING CODE 6355-01-P DEPARTMENT OF JUSTICE Drug Enforcement Administration 21 CFR Part 1312 [Docket No. DEA-282F] RIN 1117-AB03 Authorized Sources of Narcotic Raw Materials AGENCY: Drug Enforcement Administration (DEA), Department of Justice. ACTION: Final rule. SUMMARY: The Drug Enforcement Administration
(DEA)is amending the list of non-traditional countries authorized to export narcotic raw materials
(NRM)to the United States by removing Yugoslavia and adding Spain. This rule provides DEA registered importers with another potential source from which to purchase NRM that are used in the production of controlled substances for medical purposes in the United States. DATES: *Effective Date:* This rule is effective March 7, 2008. FOR FURTHER INFORMATION CONTACT: Christine A. Sannerud, PhD, Chief, Drug and Chemical Evaluation Section, Office of Diversion Control, Drug Enforcement Administration, Washington, DC 20537, telephone
(202)307-7183. SUPPLEMENTARY INFORMATION: Background and Legal Authority DEA enforces the Comprehensive Drug Abuse Prevention and Control Act of 1970, often referred to as the Controlled Substances Act
(CSA)and the Controlled Substances Import and Export Act (21 U.S.C. 801, *et seq.* ), as amended. DEA regulations implementing these statutes are published in Title 21 of the Code of Federal Regulations (CFR), Parts 1300 to 1316. These regulations are designed to ensure that there is a sufficient supply of controlled substances for legitimate medical, scientific, research, and industrial purposes and to deter the diversion of controlled substances to illegal purposes. The CSA and its implementing regulations are consistent with United States treaty obligations that, among other things, address the production, import, and export of controlled substances. Controlled Substances Controlled substances are drugs that have a potential for abuse and psychological and physical dependence, including opiates, stimulants, depressants, hallucinogens, anabolic steroids, and drugs that are immediate precursors of these classes of substances. DEA lists controlled substances in 21 CFR Part 1308. The substances are divided into five schedules. Schedule I substances have a high potential for abuse and have no accepted medical use in treatment in the United States. These substances may only be used for research, chemical analysis, or manufacture of other drugs. Substances listed in schedules II—V have accepted medical uses but also have potential for abuse and psychological and physical dependence. Narcotic raw materials (opium, poppy straw, and concentrate of poppy straw (CPS)) are in schedule II and are the materials from which morphine, codeine, thebaine and oripavine are extracted for purposes of manufacturing a number of schedule II and III controlled substances. Sources of Narcotic Raw Materials In May 1979, the United Nations' Economic and Social Council (ECOSOC) adopted Resolution 471, which called on importing countries such as the United States to support traditional suppliers of NRM and to limit imports from non-traditional supplying countries. The resolution, which was reaffirmed by ECOSOC in 1981, was adopted to limit overproduction of NRM, to restore a balance between supply and demand, and to prevent diversion to illicit channels. The United States, based on long-standing policy, does not cultivate or produce NRM, but relies solely on opium, poppy straw, and CPS produced in other countries for the NRM necessary to meet the legitimate medical needs of the United States. In response to Resolution 471, on August 18, 1981, DEA published a final rule specifying certain source countries of NRM (46 FR 41775); the rule is frequently referred to as the 80/20 rule. Under the final rule, currently codified at 21 CFR 1312.13(f) and (g), NRM can be imported from only seven countries. Traditional suppliers India and Turkey must be the source of at least 80 percent of the United States' requirement for NRM. Five non-traditional supplier countries—France, Poland, Hungary, Australia, and Yugoslavia—may be the source of not more than 20 percent. The 80/20 rule is calculated based on the amount of morphine alkaloid contained in the NRM. The United States continues to reaffirm its support of the original resolution by supporting similar resolutions each year at the Commission on Narcotic Drugs. Just as with DEA's 1979 **Federal Register** publication first proposing the 80/20 rule (44 FR 33695), it is important to recite here some of the central principles of Resolution 471, which remain crucial today: Noting that in recent years there has been considerable stepping up of morphine producing capacity for export, leading to a situation of substantial overproduction of opiates, Recognizing that it is essential to bring about a proper balance between the global supply and demand, Taking note of the continued reliance placed by the world community on countries constituting the traditional sources of supply for its medical needs of opiate raw materials and the positive response of these countries in meeting the world requirements and their contribution in the maintenance of effective control systems; Bearing in mind that the treaties which establish this system are based on the concept that the number of producers of narcotic materials for export should be limited in order to facilitate effective control; * * * In view of these principles underlying Resolution 471, DEA stated in proposing the 80/20 rule in 1979: The United States is a significant importer of narcotic raw materials. Its manufacturers account for one-third of the world morphine manufacturing capacity, most of which is consumed within the United States in the form of codeine. 1 The worldwide over-production of narcotic raw materials and [Resolution 471] make it necessary for the United States to reevaluate past and present narcotic policies. 1 Today, the United States remains a significant importer of narcotic raw material. Its manufacturers currently account for one-fourth of the world morphine manufacturing capacity, with roughly two-thirds being utilized for the production of codeine, which is consumed as either codeine or hydrocodone. Historically, the United States has relied exclusively upon imports of opium gum to manufacture our narcotic medical supplies instead of cultivating opium poppies in the United States. The rationale behind this 57-year-old policy, which foregoes [sic] U.S. self-sufficiency, was to set an example to the world community to refrain from overproduction and to limit the number of opium-producing nations to a minimum. [44 FR 33696, June 12, 1979] The foregoing principles remain central to United States drug control policy and this final rule amending the 80/20 rule. Of the countries included in the 80/20 rule, India is the only country that cultivates poppies for production of opium. All other exporting countries use the CPS method of NRM production, a method that allows the plant to go to seed; portions of the plant are then processed into a concentrate. It is generally believed that CPS is less divertible than opium. CPS may be rich in morphine (CPS-M), rich in thebaine (CPS-T), or rich in oripavine (CPS-O). The United States imports the majority of its CPS-M from Turkey, with Australia supplying the vast majority of the balance. The vast majority of CPS-T and all CPS-O are imported from Australia. The 80/20 rule was established based on traditional import amounts and on the United Nations resolution calling on member nations to support traditional sources that have been reliable suppliers and to take measures that curtail diversion. The United States allowed a limited number of non-traditional suppliers to have access to the United States market based on past commercial relationships and on the desirability of preserving alternative sources. This approach was consistent with the United Nations Resolution because it supported India and Turkey and ensured an adequate and uninterrupted supply of NRM while limiting the number of supplying countries. Over the last ten years, pursuant to the 80/20 rule, DEA registered importers of NRM have imported 90 percent of United States NRM requirements from traditional suppliers India and Turkey. DEA continues its support of the intent of the 80/20 rule. On June 6, 2005, the Kingdom of Spain (hereinafter referred to as Spain) petitioned DEA seeking to be added to the list of non-traditional suppliers. Spain stated four reasons that granting its petition would be consistent with United States interests: • The change would be consistent with the 80/20 rule because it maintains India and Turkey as the two traditional supplier countries, that is, Spain does not seek to be added to the list of traditional suppliers. • The change would ensure adequate supplies of NRM. • The change would not result in diversion because Spain maintains strict control and oversight over the cultivation and distribution of NRM. • The change would allow DEA to monitor diversion and maintain cost-effective supplies. In its petition, Spain explained that in the early 1970s, Spanish pharmaceutical firms sought authorization to cultivate opium poppies to produce NRM. In 1973, the Government of Spain authorized a single firm, Alcaliber, S.A., to cultivate, harvest, store, and prepare extracts from the opium poppy. Spain is now the fifth largest cultivator of opium poppies; Spain is the fourth largest producer of CPS and the third largest exporter of CPS-M. 2 Spain has ratified international agreements to control production and commerce in opium products. As stated in its petition, Spain has implemented a comprehensive regulatory regime for controlling the cultivation, production, and export of NRM in accordance with international treaty requirements. The petition stated that this control ensures that NRM produced in Spain are not diverted to illicit uses. 2 “Narcotic Drugs: Estimated World Requirements for 2005—Statistics for 2003”, Tables II and XIII; International Narcotics Control Board (E/INCB/2004/2). After review of the petition, DEA published a Notice of Proposed Rulemaking
(NPRM)in the **Federal Register** on October 4, 2006 (71 FR 58569) to amend the list of non-traditional countries authorized to export NRM to the United States. Specifically, the proposed rule sought to revise the list of non-traditional suppliers by removing Yugoslavia and replacing it with Spain. At that time, DEA had determined that the successor states to Yugoslavia no longer produced NRM for export beyond Yugoslavia's prior border (e.g., Serbia and Montenegro reported exports to the Republic of Macedonia (hereinafter referred to as Macedonia) only). Therefore, DEA concluded that replacing Yugoslavia with Spain would continue to limit the number of non-traditional suppliers to the United States while ensuring the availability of an adequate number of sources of NRM for United States manufacturers. The proposed change would not otherwise affect the implementation of the 80/20 rule. Comments Received Following publication of the Notice of Proposed Rulemaking on October 4, 2006, DEA received a request for a 60-day extension to the comment period. On December 1, 2006, DEA extended the comment period of the proposed rule to January 3, 2007 (71 FR 69504). During the comment period, DEA received 14 comments from 13 interested parties. Five comments were received from the following countries: Australia, Spain, Macedonia, and Turkey. One of the comments received from a foreign Government was a joint comment with a foreign control board. Three comments were received from three DEA-registered importers of NRM; one comment was received from a DEA-registered opiate manufacturer; one comment was received from a non-DEA registered firm; two comments were received from two foreign NRM manufacturers; and two comments were received from one individual. As part of the above-listed comments, DEA also received a request to extend the comment period, and four requests for a hearing. After the comment period had ended, DEA received an additional comment from a foreign NRM manufacturer. This prompted two additional late comments, one from the foreign control board which previously commented on the NPRM and the other from the foreign government associated with that foreign control board. Specifically, both commenters sought clarification from DEA on the status of the late comment, which DEA had administratively added to the docket. The Administrative Procedure Act
(APA)does not address the issue of late comments, and the United States courts generally defer to federal agencies in their handling of late comments. It is the policy of the DEA that comments not properly filed, e.g., comments postmarked after the close of a comment period, will not be considered by the agency in its deliberative process. Accordingly, the late comment from the foreign NRM manufacturer was not considered by DEA in this Final Rule. All comments received during the comment period are summarized here and discussed further below. Comments in Support of DEA's NPRM Four of the commenters supported the proposed rule. These commenters included the Government of Spain, a DEA registered NRM importer, one foreign NRM manufacturer, and a DEA-registered opiate manufacturer. One of the DEA registrants commented that the need to ensure an adequate number of sources of NRM for DEA-registered NRM importers is “most keenly felt in CPS-T and CPS-O, for which the U.S. demand is rapidly growing and in which global supply sources to the U.S. are currently quite limited.” Comments Raising Concerns to DEA's NPRM Nine of the commenters raised various concerns regarding the NPRM. These commenters included the Government of Australia, the Government of Macedonia, and the Government of Turkey; a foreign NRM control board; two DEA-registered importers of NRM; one non-DEA-registered firm; one foreign NRM manufacturer; and one individual. Four commenters claimed that the proposed rule would exacerbate current global oversupplies of NRM and therefore disrupt the balance between the supply of and demand for NRM. Three commenters claimed that the proposed rule was not consistent with the intent of the 80/20 rule or international resolutions. Three commenters claimed that the proposed rule was not necessary to assist the United States in maintaining cost effective supplies of NRM. Three commenters questioned DEA's decision to replace Yugoslavia with Spain. The following additional concerns were raised. One commenter believed that the addition of Spain to the list of non-traditional NRM producing countries would lead to a proliferation of NRM-producing countries. The commenter, however, did not provide further information as to how this rulemaking would specifically lead to a proliferation of NRM-producing countries. Additionally, one commenter claimed that Spain has diversion occurring within its borders and that it could not be proven that the addition of Spain to the list of non-traditional countries would not lead to an increase in diversion within Spain. While the commenter provided a general statement regarding the diversion of controlled substances, the commenter did not provide any specific evidence regarding the diversion of narcotic raw material specifically cultivated for lawful purposes in Spain. Due to the lack of substantiation for the claims discussed above, these comments are not addressed further in this rulemaking. Request for Hearing Four commenters requested that DEA hold an administrative hearing in this matter. Two of these commenters requested a hearing prior to the issuance of the final rule. One of these commenters stated that a hearing was appropriate “given the gravity and complexity of the issues involved.” The other commenter stated that a hearing would “provide interested parties with the fullest opportunity to make their views known and have their positions considered.” These commenters did not proffer any specific information beyond that submitted in the written comments, however, that would be brought to light if their requests for a hearing were granted. DEA has determined that an oral hearing prior to the issuance of this rule is unnecessary. The amendment of the 80/20 rule to substitute one non-traditional country for another that no longer exists in the form it did at the time of the promulgation of the original rule does not represent a major change in DEA policy or procedure. Moreover, DEA has carefully considered all of the comments received in connection with the proposal, and finds that the comments fully set forth the issues relevant to this rulemaking. Based on information provided in the comments, information provided in technical reports by the International Narcotics Control Board (INCB), and information provided by U.S. importers of NRM pursuant to DEA regulations, DEA has been able fully to address the relevant issues set forth in the comments and has determined that conducting a hearing would not materially add to the administrative record. DEA has concluded, therefore, that such a hearing would be unnecessary. Two other commenters requested a hearing following the issuance of the final rule, if it is issued. Such a request does not conform procedurally with traditional rulemaking procedures under the APA, under which—if an agency holds a hearing in connection with a proposed rule—it is held prior to the issuance of the final rule. Moreover, neither the CSA nor DEA regulations provide for an administrative hearing to “appeal” the promulgation of a final rule. Pursuant to 21 U.S.C. 877, exclusive jurisdiction for appeals of DEA final decisions such as this rule rests with the United States Courts of Appeals. Accordingly, the requests for a hearing if the final rule is issued are denied. Other Comments Received One of the commenters wrote that if the proposal sought to change the method by which the 80/20 rule was calculated, then the commenter would object to the proposed rule. As noted previously, the 80/20 rule is calculated based on the amount of morphine alkaloid contained in the NRM. Since DEA's proposed rule and this rulemaking do not affect how the 80/20 rule is calculated, this matter is not addressed further in this rulemaking. One commenter submitted two comments. One of these comments stated, “So we are deciding who to allow to do the exporting of substances that are used to make heroin? We allow this? And then kick down the doors of terminally ill patients who smoke marijuana just to ease their pain. * * *” The other comment promoted the use of hallucinogens. NRM imported into the United States pursuant to this rule are used to make legitimate medicines that are used to treat pain, not to manufacture heroin. Heroin production and the use of marijuana and hallucinogens are not the subject of this rulemaking; these matters are therefore not addressed further in this rulemaking. Support for DEA's NPRM Adequate Supply of NRM Three commenters addressed the need to ensure adequate supplies of NRM for United States markets. One commenter noted that the need to ensure an adequate number of sources of NRM for DEA registered NRM importers was “most keenly felt in CPS-T and CPS-O, for which the U.S. demand is rapidly growing and in which global supply sources to the U.S. are currently quite limited.” *DEA Response:* DEA agrees that United States sources of NRM are limited based on data it collects quarterly from DEA registered importers pursuant to 21 CFR 1304.31. The data collected in these reports include the relative amounts of morphine, codeine, thebaine and oripavine contained in each individual NRM import to the United States as reported by each of the five DEA registered NRM importers. In response to this comment, DEA conducted an analysis of the source of each of the primary alkaloids available in current NRM: morphine, thebaine and oripavine. DEA notes that, in 2006, imports of NRM had as their source, four of the seven countries authorized to export NRM to the United States, specifically India, Turkey, Australia and France. United States importers have not imported NRM from Poland or Yugoslavia since at least 1985, and imports from Hungary were minimal in the mid to late 1990s and have ceased altogether since 2002. No imports from Poland, Yugoslavia, or Hungary are anticipated in 2007. Since NRM contain a mixture of these alkaloids, DEA's review of the NRM import situation (below) is expressed in terms of the amount of morphine, thebaine, and oripavine contained in imported NRM. *Morphine:* Morphine is the principal alkaloid in Indian opium and Turkish CPS-M and has historically been the principal alkaloid extracted from NRM in the United States. Morphine continues to be utilized in the United States for the manufacture of morphine-based pharmaceutical products; the manufacture of codeine, which is utilized to manufacture codeine-based pharmaceutical preparations and hydrocodone; and the manufacture of hydromorphone. Based on an analysis of information received for 2006, imports of NRM totaled 124,000 kg of morphine (124.0 metric tons (MT)), having the following countries as its source: Turkey (59.9 MT morphine; 48.3 percent), India (43.9 MT morphine; 35.4 percent), and Australia (20.4 MT morphine; 16.5 percent). 3 When reviewing imports of morphine over the last 10 years (1997-2006), United States importers obtained commercial quantities of morphine from India, Turkey, and Australia, with lesser amounts obtained from France and Hungary. DEA concludes as a result that the United States has at least three geographically distinct countries from which morphine is obtained, each with large production capacity on which the United States could rely if any of those countries were to experience a hardship (i.e., crop failure, labor strife, etc.). Adding Spain would provide DEA registered importers with a fourth country from which to purchase NRM. 3 Percentages may not add to 100 percent due to rounding. *Thebaine:* Thebaine is the principal alkaloid in CPS-T. CPS-T is available to the United States market from Australia and France. Thebaine is also present in Indian opium at approximately one sixth the level of morphine, thus the amount of thebaine obtained from India is directly related to the amount of morphine that United States importers import from India. In the United States, thebaine is utilized for the manufacture of oxycodone, a schedule II controlled substance. More recently, oxycodone has been utilized for the manufacture of oxymorphone, another schedule II controlled substance. Oxycodone use in the United States has increased tremendously over the last 10 years. For example, the aggregate production quota for oxycodone, which represents the maximum amount that may be manufactured in the United States to meet the estimated medical, industrial, scientific, and research needs of the United States; for lawful export requirements; and the maintenance of reserve stocks, has increased over the last decade from 5,275 kg in 1997 to 49,200 kg in 2006. The large increase in oxycodone use in the United States followed the approval and marketing in 1995 of a high dose, single-entity, extended-release drug formulation known as OxyContin. Although DEA remains concerned over the diversion and abuse of OxyContin and other formulations that contain high doses of potent schedule II controlled substances, the Food and Drug Administration continues to advise DEA of double-digit growth in the oxycodone market through 2008. This provides evidence that the demand for thebaine-rich NRM that must be imported into the United States for this purpose will also continue to increase. When the same 2006 quarterly statistical import data was reviewed for thebaine, DEA noted that 78.2 MT of thebaine was imported into the United States in 2006, having as its source the following countries: Australia (66.8 MT of thebaine; 85.4 percent), India (7.1 MT of thebaine; (9.1 percent), and France (4.1 MT of thebaine; 5.2 percent). 4 Thus, Australia was the source of 85 percent of United States thebaine requirements in 2006. 5 For comparison, in 2005, 73 percent of the 65.4 MT of thebaine imported into the United States had Australia as it source, and, in 2004, 75 percent of the 66.8 MT were imported from Australia. In 2007, United States importers have reported their plans to import 92 percent of their thebaine requirements from Australia; they planned to import the remaining 8 percent solely from India. 4 Ibid. 5 As discussed previously, The 80/20 rule is calculated based on the amount of morphine alkaloid contained in the NRM. As this discussion relates to the amount of thebaine alkaloid in the NRM, not morphine, the 85 percent obtained by the United States from Australia does not violate principles of the 80/20 rule. DEA notes that Australia has a stellar record in providing thebaine-rich NRM to the United States, with little (if any) record of diversion. DEA further notes that the United States and Australia have excellent relations in this area, and contrary to comments made by some commenters to this NPRM, DEA's proposed rule and this final rule in no way suggest that Australia has “not ensured an adequate and uninterrupted supply” of NRM to the United States. DEA remains mindful, however, of the potential impact of a hardship (i.e., crop failure, labor strife, etc.) in Australia that could lead to a temporary lack of availability of thebaine to the United States market. In this circumstance, the United States would be required to obtain much larger volumes of NRM from either India or France in order to meet thebaine demand. Although France has demonstrated the capability of exporting up to 16 MT of thebaine in a single year to the United States, India's capacity to export thebaine, as mentioned above, is directly related to the amount of morphine that importers wish to import from India consistent with the 80/20 rule. Therefore, importing vast quantities of Indian opium to meet United States thebaine demands would be impractical because it would result in the importation into the United States of excessive amounts of morphine, which could then be the subject of diversion and abuse. Thus, the amount of thebaine that could be derived from India, consistent with United States requirements for morphine contained in Indian opium, is likely to be 6-8 MT annually. DEA concludes that the United States has limited sources from which to obtain thebaine derived from NRM. The United States relies on three countries for thebaine, but two of these countries have a limited capacity to support the increasing size of the United States' market for thebaine. DEA notes that, in 2004, the Government of Spain reported for the first time commercial production of CPS-T, so Spain would represent a fourth country from which CPS-T could be imported. As a result, this rule will provide DEA registered importers with another source from which to purchase CPS-T for the production of medicines. *Oripavine:* Oripavine, a schedule II controlled substance, is the principal alkaloid found in Australian CPS-O and is a minor constituent in French CPS-T. Oripavine is becoming an increasingly important intermediate in the United States for the manufacture of buprenorphine, a schedule III controlled substance, oxymorphone, and a number of controlled and non-controlled substances referred to generally as “opiate antagonists” (naltrexone for example, and its derivatives). Using the same import data, DEA notes that, in 2006, 9.7 MT of oripavine was imported into the United States having Australia as its source, virtually 100 percent of the United States' oripavine requirements. In 2005, 4.1 MT were imported from Australia and in 2004, 9.4 MT were imported with roughly 86 percent imported from Australia. United States importers have reported their plans to import 100 percent of the 9.7 MT of oripavine from Australia in 2007. DEA therefore concludes that the United States has limited sources from which to obtain oripavine derived from NRM. Objections to DEA's NPRM Global Oversupply of Narcotic Raw Materials The Government of Australia's primary concern regarding DEA's proposed rule is that this rule would “exacerbate global oversupply” of NRM. In its comment, the Government of Australia pointed to statistical data published by the INCB in its report, “Narcotic Drugs: Estimated World Requirements for 2006—Statistics for 2004,” which the Government of Australia characterized as demonstrating that global production of both morphine-rich and thebaine-rich NRM have been in excess of global utilization since at least 2001. As a result of overproduction, the Government of Australia argued, global supplies have increased. The DEA-registered NRM importer stated that “Alcaliber [the sole Spanish poppy cultivator] made a significant investment in capacity, dramatically increased production contributing significantly to global overproduction and excess stocks, and now wants access to the U.S. market to allow it to increase production further to help recover its investment.” The importer further stated that the Notice of Proposed Rulemaking sent the message that “If a country adds production capacity, uses it aggressively and thereby contributes to the world's build up of excess stocks, the U.S. will accommodate this behavior and reward it with access to the U.S. market. The U.S. will simply delete a smaller producer from the list.” This commenter also stated that “Spain was arguably the primary source of this build up in excess morphine stocks.” Finally, the foreign opiate manufacturer stated that “Spain's rapid expansion of its domestic industry, its aggressive approach to building export markets, its building of clearly excessive stockpiles and capacity, and supply into a market already in over-supply is not * * * broadly in accordance with the obligations under the Single Convention, or the Resolutions.” *DEA Response:* DEA disagrees that Spain is the “primary” source of any build-up of global excesses in morphine stocks. Instead, DEA concludes that all countries that produce NRM contribute to the current global excess of NRM. Among many of the requirements of NRM-producing countries, in accordance with the Single Convention on Narcotic Drugs, 1961, is a requirement to provide annual statistics to the INCB, including estimated amounts of NRM to be cultivated and the amount of NRM to be produced therefrom. The INCB utilizes these estimates along with other statistical data it collects, in accordance with the Single Convention, to monitor and analyze the global supply of and demand for NRM. The results of this analysis are published in a technical report series, which in 2004 was entitled, “Narcotic Drugs: Estimated World Requirements for 2006; Statistics for 2003.” The analysis conducted by the INCB and the statistical reports published continue to be an excellent resource for governments of consumer countries such as the United States. A review of this report series for 2004 and 2005 was conducted with relevant statistical data provided in Tables 1 and 2. Analysis for Morphine-Rich Poppies Table 1.—“Global Cultivation of Morphine-Rich Poppies (Hectares) for Licit Purposes Other Than Production of Opium” Country 2003
(ha)2004
(ha)2005 (ha-est.) 2006 (ha-est.) Australia 9,811 6,644 6,700 4,900 People's Republic of China 1,250 1,000 1,300 1,200 Czech Republic 21,045 16,030 25,000 38,000 France 7,919 8,312 8,500 9,100 Hungary 2,937 7,084 14,000 12,000 Slovakia 332 326 550 Spain 5,732 5,986 7,002 6,002 Republic of Macedonia 51 91 1,500 1,500 Turkey 99,430 30,343 70,000 70,000 United Kingdom 1,534 1,534 1,500 Total 150,041 77,350 136,052 142,702 Neither DEA, nor any commenter, identified a single instance in these reports in which the INCB raised concerns over Spain's purported role in the global excess of production and the resulting oversupply of NRM presently on hand. According to this publication, Spain was one of eleven countries that cultivated morphine-rich poppies in 2003 for licit pharmaceutical purposes (i.e. non-culinary use). Spain planted 5,732 hectares of poppies and produced roughly 4.7 percent of the world's morphine-rich poppy straw. Spain's share of world production of poppy straw increased in 2004 to 10.7 percent; the increase was attributed to both an increase in 2004 acreage sown in Spain and a large decrease in acreage sown by the primary cultivator of poppies for this purpose, Turkey. Estimates for the “area to be cultivated” for 2005 and 2006 suggest that Spain will be responsible for 5.1 percent of the area under cultivation and had plans to decrease its area under cultivation in 2006 to 4.2 percent. Although Spain remains one of the five largest cultivators of morphine-rich poppies in the world, DEA concludes that Spain, like all other producer and consumer countries, contributes to what the INCB qualifies as a “high” level of stocks of raw materials rich in morphine. Analysis of Thebaine-Rich Poppies Table 2.—“Global Cultivation of Thebaine-Rich Poppies (Hectares) for Licit Purposes Other Than Production of Opium” Country 2003
(ha)2004
(ha)2005 (ha-est.) 2006 (ha-est.) Australia 7,637 5,578 6,500 5,300 People's Republic of China 34 40 50 France 1,499 1,007 1,100 1,000 Spain 996 500 1,000 Total 9,170 7,581 8,140 7,350 Australia is the principal cultivator of thebaine-rich poppies and is responsible for the vast majority of thebaine-rich CPS that is produced and imported into the United States. Although the INCB notes that production of thebaine-rich NRM exceeded demand substantially until 2002, DEA notes that the primary cultivators, Australia and France, began decreasing areas under cultivation in 2003 and have made significant decreases since that time in order to bring production in line with utilization. Although Spain noted cultivation of thebaine-rich poppies for the first time in 2004, it is not responsible for excess production that resulted in excess supplies before then. Consistency With the 80/20 Rule and International Resolutions As stated in DEA's Notice of Proposed Rulemaking, the 80/20 rule was promulgated following a resolution adopted by the United Nations' Economic and Social Council (ECOSOC) in 1979. In response to the resolution in 1979, DEA published an Advance Notice of Proposed Rulemaking (44 FR 33695, June 12, 1979) and then a Notice of Proposed Rulemaking (45 FR 9289, February 12, 1980). The comments resulting from the Notice of Proposed Rulemaking led to an administrative hearing. On August 18, 1981, DEA published a final rule promulgating the 80/20 rule (46 FR 41775). Objections to the current Notice of Proposed Rulemaking pointed to specific comments in the 1979 resolution, the Notice of Proposed Rulemaking, the transcript of the administrative hearing, and considerations made by then-Acting Administrator Francis Mullen, Jr., in DEA's 1981 Final Rule. The foreign opiate manufacturer stated that the 1979 ECOSOC resolution called on “importing countries to * * * take effective steps to support their traditional supplier countries” and urged “major producing and manufacturing countries to which have set up [sic] additional capacity in recent years to take effective measures to restrict substantially their production levels to assure a lasting balance between supply and demand and to prevent drug diversion to illicit channels.” The commenter believed that “[a]llowing Spain to now enter the market directly contradicts and undermines the objective of the Current 80/20 Rule, and rewards a country for engaging in the very conduct the Current 80/20 Rule, and the Resolutions, were intended to discourage or stop.” The DEA-registered NRM importer who filed objections to the NPRM provided a summary of the determinations of fact made by Francis Young, the Administrative Law Judge
(ALJ)who presided over the hearing in 1980; these findings were adopted by then-Acting Administrator Mullen when the final rule was promulgated. The DEA-registered importer provided the following summary of ALJ Young's determinations of fact: “(1) DEA could lawfully promulgate the regulatory amendments limiting the importation of narcotic raw materials;
(2)the Administrator of DEA could lawfully require that a major portion of the [NRM] imported into the United States be produced in India and Turkey while permitting the remainder of the U.S. needs to be imported from other countries which maintain adequate control;
(3)such allocation would be in harmony with U.S. trade agreements and would not be inconsistent with Resolution 471 and 497; and
(4)DEA staff should determine an allocation ratio based upon world market shares during a recent representative period.” This commenter further noted that the 1981 final rule “established clearly stated criteria for selecting the other countries that could supply the United States market with NRM:
(a)France, Hungary, Poland, and Yugoslavia ‘provided the United States with [NRM] during the period 1975 through 1979 and present alternate sources’ and Australia ‘was the source of material for which import permits had been requested during the time period’ and
(b)Each country did ‘impose adequate controls over their production of narcotic raw materials in adherence to their obligations under the Single Convention’.” *DEA Response:* DEA disagrees with the commenters' assessments that this rule is inconsistent with the intent of the 80/20 rule and international resolutions. DEA finds that the proposed rule is consistent with both the 1979 resolution and the 80/20 rule. *Consistency with 1979 Resolution:* The text of the 1979 resolution contained separate and distinct operative language for Governments of importing countries (i.e., the United States) and Governments of producer countries. The operative paragraph for importing countries: “Urge[d] the Governments of the importing countries that have not already done so to take effective steps to support the traditional supplier countries and to give those countries all the practical assistance they can in order to prevent the proliferation of sources of production of narcotic raw materials for export[.]” 6 6 Resolution 1979/8 of the Economic and Social Council. “Maintenance of a world-wide balance between the supply of narcotic drugs and the legitimate demand for those drugs for medical and scientific purposes.” Neither DEA nor the commenters disagree that the United States meets the first prong of this operative paragraph, i.e., the support of “traditional supply countries,” by providing India and Turkey with access to at least 80 percent of the United States market for morphine contained in NRM. As has been stated throughout this rule, DEA remains committed to this obligation through its continued support of the 80/20 rule. The commenter's objections would, therefore, fall under United States' obligations under the second prong of this operative paragraph, namely to give all practical assistance in preventing the proliferation of producing countries. Since it is not refuted that the Government of Spain has been engaged in the production of NRM since 1974, prior to international calls to prevent proliferation, DEA concludes that the Government of Spain is not a new or emerging participant in the global production of NRM. The addition of Spain to the 80/20 rule will not result in a proliferation of producer countries. DEA therefore concludes that this action is consistent with the 1979 resolution. *Consistency with the 80/20 rule:* As stated in the proposed rulemaking and reaffirmed in this final rule, DEA concludes that adding Spain to the list of countries authorized to export NRM to the United States is consistent with the 80/20 rule. Specifically, adding Spain is consistent with the criteria established by then-Acting Administrator Mullen when establishing Yugoslavia, France, Poland, Hungary, and Australia as the list of non-traditional suppliers in 1981. In the 1981 Final Rule, then-Acting Administrator Mullen stated: However, in view of the past commercial relations with certain other countries as sources of narcotic raw material supply and the desirability of preserving alternate sources of narcotic raw materials, it is appropriate to allow certain specific countries to compete for the U.S. narcotic raw materials market on a limited basis. These countries, France, Poland, Hungary and Yugoslavia have provided the United States with supplies of narcotic raw materials during the period 1975 and 1979 and represent appropriate alternate sources. Australia is included as well since it was the source of material for which import permits had been requested during that time period. In addition, we are presently persuaded that the nations mentioned above impose adequate controls over their production of narcotic raw materials in adherence to their obligations under the Single Convention. (46 FR 41775). Then-Acting Administrator Mullen reaffirmed DEA's obligations to preserve alternate sources of NRM for the United States market. In an effort to determine the sources from which NRM could be derived, he established the following two criteria in designating the list of alternate sources:
(1)The country had to have supplied the United States with NRM for a period of five years prior to the resolution's passage in 1979 and
(2)the country had to have imposed adequate controls over the production of NRM consistent with its obligations under the Single Convention. In his decision, then-Acting Administrator Mullen created an exception to the first criterion; this exception allowed the Government of Australia to be added to the list of non-traditional suppliers. Specifically, then-Acting Administrator Mullen found that, if a country was not the source of imports during the period 1975-1979, then the country had to be a source from which DEA-registered importers of NRM had requested authority to import. Although Australia did not export NRM to the United States during the period 1975-1979, it was added because DEA-registered NRM importers had expressed interest in importing from Australia and had submitted to DEA the required “Application for Permit to Import Controlled Substances for Domestic and/or Scientific Purposes” (DEA-357) from Australia. Based on this exception, one could conclude that Spain, despite not having been a source of NRM to the United States from 1975-1979, could qualify consistent with the 80/20 rule if a DEA-registered importer had expressed its interest in importing from Spain by filing a DEA-357, requesting authorization to do so. DEA notes, however, that the filing of such an application by a DEA-registered importer at present would be inconsistent with DEA regulations, specifically the 80/20 rule, and would therefore be impractical. Instead, interest in importing NRM from Spain arose through this rulemaking; DEA notes that one DEA-registered NRM importer expressed its interest in importing NRM from Spain during the comment period. DEA also notes that, during routine annual discussions with its five DEA-registered NRM importers before the receipt of the petition from the Government of Spain, the majority expressed some degree of interest in importing from Spain. Neither the commenters nor DEA disagree with the statements of fact made by the Government of Spain that it has implemented a system of domestic controls for the handling of NRM that are consistent with the Single Convention; DEA concludes, as a result, that the second criterion has been satisfied. DEA finds that adding Spain to the list of non-traditional suppliers is consistent with the criteria established in 1981 by then-Acting Administrator Mullen and is therefore consistent with the 80/20 rule. Cost of Narcotic Raw Materials One DEA-registered importer of NRM stated that DEA's Notice of Proposed Rulemaking “will do little or nothing to improve adequacy of supply or the cost of NRMs for the U.S.” The Government of Australia, in its comments to the DEA's proposed rule stated that “Spain's petition presents no evidence to justify a need for change on the basis of adequacy of supply nor the cost effectiveness of that supply” and that “there is no real issue with cost.” Finally, the foreign opiate manufacturer stated that there is no evidence that the proposed rule would maintain cost-effective supplies and that there is “no suggestion that current supplies are not cost effective.” *DEA Response:* DEA agrees that there is no evidence provided in the petition from Spain that the addition of Spain to the 80/20 rule would lead to more cost-effective supplies of NRM. This remains an open question. DEA does not routinely collect information relating to the cost of NRM or the opiates manufactured therefrom. Some of the commenters, however, provided data that demonstrate that the costs of NRM have steadily declined over the last five years and are presently at “record lows.” For example, the DEA-registered importer of NRM that objected to the NPRM stated that the price of CPS-M from Turkey was $660 per kilogram in 2001 and will be $300 per kilogram in 2007. The same commenter noted that CPS-T was $825 per kilogram in 2001 and will be $500 per kilogram in 2007. The foreign opiate manufacturer stated that, “taking the United States supply price in 2001 as a benchmark, the 2006 average price of Thebaine to the United States has declined over 20%.” Given the increasing demand for thebaine, the foreign opiate manufacturer contends that a decrease in price suggests a “robust competitive environment.” DEA disagrees with the implication made by the Government of Australia, however, in its statement that “Spain's assertion that its inclusion would further an underlying policy objective of the 80/20 Rule by ensuring an adequate and reliable supply at a stable price is based on a premise that prices of NRM have not been stable.” DEA concludes instead that the prices of NRM are directly related to the global stocks of these materials, which for more than the last 5 years have been in excess of global demand. For example, in the 2005 INCB publication, “Narcotic Drugs: Estimated World Requirements for 2006—Statistics for 2004,” the INCB reported that “global production of opiate raw materials rich in morphine exceeded global demand considerably during the period 2002-2004.” For opiate raw materials rich in thebaine, the INCB reported that “the total supply (production and stocks) continued to be above global demand also for thebaine-rich raw materials * * * and that the balance between supply and demand will continue to be positive.” DEA therefore concludes that the decrease in price noted by the commenters is more a function of excess supply rather than evidence of “robust competition,” for, as noted, Australia supplies the vast majority of the United States' demand for thebaine. DEA further concludes that maintaining cost-effective supplies of NRM to the United States equates to striking a global balance between supply of and demand for NRM. For producer countries such as India, Turkey, Australia, France and Spain, this means reducing areas of cultivation in times when global supplies are in excess and increasing production (to the extent possible) if and when hardship arises in a producer country that results in global demand being in excess of supply. For consumer countries, such as the United States, this equates to:
(1)Ensuring that there are an adequate number of sources from which to procure NRM during times in which supplies are not in excess,
(2)communicating accurate estimates of United States requirements for NRM to authorized exporting countries, and
(3)working with the international community, including the INCB, to ensure a global balance between supply and demand. Replacing Yugoslavia With Spain The Republic of Macedonia (Macedonia) forwarded a letter prepared by the only company licensed in Macedonia to purchase poppy straw and manufacture opiate alkaloids. The company raised concerns regarding DEA's comment in the NPRM that “the successor states to the former Yugoslavia no longer produce NRM for export.” The company disagreed with this observation, stating that Macedonia has been “enjoying the rights arising out of the 80/20 rule for more than 25 years.” The company therefore insisted that “Yugoslavia can only be replaced on the list with its legitimate successor state Macedonia.” A second commenter stated that DEA's proposed rule sought to “replace Macedonia with Spain.” Finally, a third commenter stated that DEA ignored “the position of its [Yugoslavia's] clear successor state, namely Macedonia.” *DEA Response:* DEA disagrees with those commenters that suggest that Macedonia is the de facto successor to Yugoslavia for purposes of the 80/20 rule. Macedonia became a sovereign country only after the dissolution of Yugoslavia. As a new country, Macedonia cannot automatically replace Yugoslavia in the 80/20 rule. Macedonia is but one of five countries that were created after the dissolution of Yugoslavia in the early 1990s. Any one of the five countries would be required to petition DEA if it wished to be added to the list of countries authorized to export NRM. DEA would then be required to review the merits of any such petition in a manner consistent with DEA's review of the petition filed by Spain. DEA also disagrees with Macedonia's assessment that its manufacturers have “enjoyed” the rights arising from the 80/20 rule for the last 25 years. The company did not provide any statistical data to demonstrate previous sales to the United States or anticipated sales to the United States. In this regard, DEA conducted a review of import permits issued for NRM over the last five years and did not identify an occasion in which a United States importer requested authority to import NRM from Macedonia. Instead, according to the most recent statistics available from the INCB (statistics for 2004), Macedonia did not export opium, poppy straw, or concentrate of poppy straw from 2002 through 2004. Instead, Macedonia reported the exportation of small quantities of morphine and codeine, schedule II controlled substances whose importation into the United States is generally regarded as being prohibited by DEA regulations unless specifically requested in limited quantities for use exclusively in scientific research (21 CFR 1312.13). Conclusion Based on the comments received, statistical data on imports of NRM collected and analyzed by DEA pursuant to the Code of Federal Regulations, and reports from the INCB, DEA concludes that in order to continue to ensure an adequate supply of NRM necessary to meet the estimated medical, industrial, scientific, and research needs of the United States, for lawful export requirements, and for the maintenance of adequate stocks, it is appropriate to add Spain to the list of non-traditional countries permitted to export NRM to the United States. Regulatory Certifications Regulatory Flexibility Act The Deputy Assistant Administrator, Office of Diversion Control, hereby certifies that this rulemaking has been drafted in accordance with the Regulatory Flexibility Act (5 U.S.C. 601-612), that he has reviewed this regulation, and by approving it certifies that this regulation will not have a significant economic impact on a substantial number of small business entities. This rule imposes no new costs or burden on small entities. Rather, this rule adds Spain to the list of non-traditional countries permitted to export NRM to the United States, helping to ensure that United States importers and manufacturers will have access to, and be able to procure, supplies of NRM to meet legitimate United States medical, scientific, research, and industrial needs, to ensure maintenance of adequate reserve stocks, and to meet lawful export requirements. Additionally, this rule provides DEA registered importers with another source from which to purchase NRM which are utilized for the production of controlled substances used in the United States for medical purposes. Executive Order 12866 The Deputy Assistant Administrator, Office of Diversion Control, further certifies that this rulemaking has been drafted in accordance with the principles in Executive Order 12866 Section 1(b). It has been determined that this is a significant regulatory action. Therefore, this action has been reviewed by the Office of Management and Budget. Executive Order 12988 This rule meets the applicable standards set forth in Sections 3(a) and 3(b)(2) of Executive Order 12988. Executive Order 13132 This rule does not preempt or modify any provision of State law; nor does it impose enforcement responsibilities on any State; nor does it diminish the power of any State to enforce its own laws. Accordingly, this rulemaking does not have federalism implications warranting the application of Executive Order 13132. Unfunded Mandates Reform Act of 1995 This rule will not result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $120,000,000 or more (adjusted for inflation) in any one year, and will not significantly or uniquely affect small governments. Therefore, no actions were deemed necessary under the provisions of the Unfunded Mandates Reform Act of 1995. Congressional Review Act This rule is not a major rule as defined by Section 804 of the Small Business Regulatory Enforcement Fairness Act of 1996 (Congressional Review Act). This rule will not result in an annual effect on the economy of $100,000,000 or more; a major increase in costs or prices; or significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of United States-based companies to compete with foreign-based companies in domestic and export markets. List of Subjects in 21 CFR Part 1312 Administrative practice and procedure, Drug traffic control, Exports, Imports, Reporting and recordkeeping requirements. For the reasons set out above, 21 CFR part 1312 is amended as follows: PART 1312—IMPORTATION AND EXPORTATION OF CONTROLLED SUBSTANCES 1. The authority citation for part 1312 continues to read as follows: Authority: 21 U.S.C. 952, 953, 954, 957, 958. 2. Section 1312.13 is amended by revising paragraphs
(f)and
(g)to read as follows: § 1312.13 Issuance of import permit.
(f)Notwithstanding paragraphs (a)(1) and (a)(2) of this section, the Administrator shall permit, pursuant to section 1002(a)(1) or 1002(a)(2)(A) of the Act (21 U.S.C. 952(a)(1) or (a)(2)(A)), the importation of approved narcotic raw material (opium, poppy straw and concentrate of poppy straw) having as its source:
(1)Turkey,
(2)India,
(3)Spain,
(4)France,
(5)Poland,
(6)Hungary, and
(7)Australia.
(g)At least eighty
(80)percent of the narcotic raw material imported into the United States shall have as its original source Turkey and India. Except under conditions of insufficient supplies of narcotic raw materials, not more than twenty
(20)percent of the narcotic raw material imported into the United States annually shall have as its source Spain, France, Poland, Hungary and Australia. Dated: January 30, 2008. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control. [FR Doc. E8-2142 Filed 2-5-08; 8:45 am] BILLING CODE 4410-09-P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2007-0280; FRL-8346-9] Clothianidin; Pesticide Tolerance AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. SUMMARY: This regulation establishes a tolerance for residues of clothianidin in or on sugar beet roots, tops and molasses. Bayer CropScience requested this tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA). DATES: This regulation is effective February 6, 2008. Objections and requests for hearings must be received on or before April 7, 2008, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION) . ADDRESSES: EPA has established a docket for this action under docket identification
(ID)number EPA-HQ-OPP-2007-0280. To access the electronic docket, go to *http://www.regulations.gov* , select “Advanced Search,” then “Docket Search.” Insert the docket ID number where indicated and select the “Submit” button. Follow the instructions on the regulations.gov website to view the docket index or access available documents. All documents in the docket are listed in the docket index available in regulations.gov. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information
(CBI)or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available in the electronic docket at *http://www.regulations.gov* , or, if only available in hard copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket Facility telephone number is
(703)305-5805. FOR FURTHER INFORMATION CONTACT: Kable Bo Davis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:
(703)306-0415; e-mail address: *davis.kable@epa.gov* . SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to those engaged in the following activities: • Crop production (NAICS code 111), e.g., agricultural workers; greenhouse, nursery, and floriculture workers; farmers. • Animal production (NAICS code 112), e.g., cattle ranchers and farmers, dairy cattle farmers, livestock farmers. • Food manufacturing (NAICS code 311), e.g., agricultural workers; farmers; greenhouse, nursery, and floriculture workers; ranchers; pesticide applicators. • Pesticide manufacturing (NAICS code 32532), e.g., agricultural workers; commercial applicators; farmers; greenhouse, nursery, and floriculture workers; residential users. This listing is not intended to be exhaustive, but rather to provide a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT . B. How Can I Access Electronic Copies of this Document? In addition to accessing an electronic copy of this **Federal Register** document through the electronic docket at *http://www.regulations.gov* , you may access this **Federal Register** document electronically through the EPA Internet under the “ **Federal Register** ” listings at *http://www.epa.gov/fedrgstr* . You may also access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Government Printing Office's pilot e-CFR site at *http://www.gpoaccess.gov/ecfr* . C. Can I File an Objection or Hearing Request? Under section 408(g) of FFDCA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2007-0280 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk as required by 40 CFR part 178 on or before April 7, 2008. In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing that does not contain any CBI for inclusion in the public docket that is described in ADDRESSES . Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit this copy, identified by docket ID number EPA-HQ-OPP-2007-0280, by one of the following methods: • *Federal eRulemaking Portal* : *http://www.regulations.gov* . Follow the on-line instructions for submitting comments. • *Mail* : Office of Pesticide Programs
(OPP)Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. • *Delivery* : OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only accepted during the Docket's normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket Facility telephone number is
(703)305-5805. II. Petition for Tolerance In the **Federal Register** of April 30, 2007 (72 FR 21263) (FRL-8124-5), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 6F7159) by Bayer CropScience, 2 T.W. Alexander Drive, Research Triangle Park, NC 27709. The petition requested that 40 CFR 180.586 be amended by establishing a tolerance for residues of the insecticide clothianidin, (E)-1-(2-chloro-1,3-thiazol-5-ylmethyl)-3-methyl-2-nitroguanidine, in or on beet, sugar, root at 0.02 parts per million (ppm); beet, sugar, tops at 0.04 ppm; and beet, sugar, molasses at 0.06 ppm. That notice referenced a summary of the petition prepared by Bayer CropScience, the registrant, which is available to the public in the docket, *http://www.regulations.gov* . There were no comments received in response to the notice of filing. Upon completing review of the current clothianidin database, the Agency concluded that the appropriate tolerance levels for clothianidin residues in or on pending crops should be established as follows: Beet, sugar, roots at 0.02 ppm, beet, sugar, molasses at 0.05 ppm and beet, sugar, dried pulp at 0.03 ppm. The Agency no longer considers sugar beet tops to be a significant livestock feedstuff; therefore, a separate tolerance for tops is not required. III. Aggregate Risk Assessment and Determination of Safety Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue....” These provisions were added to FFDCA by the Food Quality Protection Act
(FQPA)of 1996. Consistent with FFDCA section 408(b)(2)(D), and the factors specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for the petitioned-for tolerance for residues of clothianidin on beet, sugar, roots at 0.02 ppm, beet, sugar, molasses at 0.05 ppm and beet, sugar, dried pulp at 0.03. EPA's assessment of exposures and risks associated with establishing the tolerance follows. A. Toxicological Profile EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. Specific information on the studies received and the nature of the adverse effects caused by clothianidin as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found at *http://www.regulations.gov* . The risk assessment is available in the docket established by this action, which is described under ADDRESSES , and is identified as EPA-HQ-OPP-2007-0280 in that docket. Clothianidin does not appear to exhibit toxicity towards a consistent specific target organ. Decreases in body weight and body weight gain were observed in rats, dogs, and mice. In single-dose studies, mice (acute toxicity category II) appear more sensitive than rats (category IV). Clinical signs of neurotoxicity were exhibited in both mice (decreased motor activity, tremors, and deep respirations at 50 milligram/kilogram (mg/kg)) and rats (transient signs of decreased arousal, motor activity, and locomotor activity at 100 mg/kg) in acute neurotoxicity studies following exposure by gavage; however, no indications of neurotoxicity were observed following dietary exposure in the subchronic neurotoxicity study in rats. In a developmental neurotoxicity study in rats, decreased body weights, body weight gains, motor activity, and acoustic startle response amplitude (females) were seen in offspring at doses lower than those resulting in maternal toxicity. Although the NOAELs were similar for the subchronic and chronic feeding studies in the rat, a greater spectrum of effects was observed in the chronic study (decreased body weight, body weight gain, and food consumption plus additional observations in the liver, ovary, and kidney) versus the subchronic study (effects only on body weight and food consumption). In the rat, administration via the oral route appears to be more toxic than via the dermal route. In longer term studies, dogs exhibited clinical signs of anemia. The only observed effects in mice following chronic dietary administration were increases in vocalization and decreases in body weight and body weight gain. Clothianidin has been classified as not likely to be carcinogenic to humans. There was no evidence of increased quantitative or qualitative susceptibility of rat or rabbit offspring in developmental studies; however, increased quantitative susceptibility of rat pups was seen in both the reproduction and developmental neurotoxicity studies. The degree of concern for both of these studies is low because the observed effects are well characterized, and there are clear NOAELs and LOAELs. The NOAEL for the effects of concern identified in the reproduction study (decreased mean body weight gain and absolute thymus weights in pups, delayed sexual maturation, and an increase in still births) is the basis for the endpoint selected for the chronic dietary and short-term, intermediate-term and long-term non-dietary risk assessments. In adult rats, a guideline immunotoxicity study shows no clothianidin-mediated immunotoxicity at doses lower than those resulting in generalized signs of toxicity (e.g., decreases in body weight); however, it cannot be concluded that a similar lack of effects will occur in offspring. Based on evidence of decreased absolute and adjusted organ weights of the thymus and spleen in multiple studies in the clothianidin data base and on evidence of increased quantitative susceptibility of juvenile rats, compared to adults, in the 2-generation reproduction study to these effects, a developmental immunotoxicity
(DIT)study has been required. B. Toxicological Endpoints For hazards that have a threshold below which there is no appreciable risk, the toxicological level of concern
(LOC)is derived from the highest dose at which the NOAEL in the toxicology study identified as appropriate for use in risk assessment. However, if a NOAEL cannot be determined, the LOAEL is sometimes used for risk assessment. Uncertainty/safety factors
(UFs)are used in conjunction with the LOC to take into account uncertainties inherent in the extrapolation from laboratory animal data to humans and in the variations in sensitivity among members of the human population as well as other unknowns. Safety is assessed for acute and chronic risks by comparing aggregate exposure to the pesticide to the acute population adjusted dose
(aPAD)and chronic population adjusted dose (cPAD). The aPAD and cPAD are calculated by dividing the LOC by all applicable UFs. Short-term, intermediate-term, and long-term risks are evaluated by comparing aggregate exposure to the LOC to ensure that the margin of exposure
(MOE)called for by the product of all applicable UFs is not exceeded. For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk and estimates risk in terms of the probability of occurrence of additional adverse cases. Generally, cancer risks are considered non-threshold. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see *http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm* . A summary of the toxicological endpoints for clothianidin used for human risk assessment can be found at *http://www.regulations.gov* in document “Clothianidin: Human Health Risk Assessment for Proposed Use on Sugar Beet” at pages 18-20 in docket ID number EPA-HQ-OPP-2007-0280. C. Exposure Assessment 1. *Dietary exposure from food and feed uses* . In evaluating dietary exposure to clothianidin, EPA considered exposure under the petitioned-for tolerances as well as all existing clothianidin tolerances in (40 CFR 180.586). EPA assessed dietary exposures from clothianidin in food as follows: i. *Acute exposure* . Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure. In estimating acute dietary exposure, EPA used food consumption information from the U.S. Department of Agriculture
(USDA)1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII). The acute assessment is based on maximum residues of clothianidin observed in clothianidin and thiamethoxam field trials and assumes 100 percent crop treated (%CT). ii. *Chronic exposure* . In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA 1994-1996 and 1998 CSFII. The chronic assessment is based on average residues from clothianidin and thiamethoxam field trials and assumes 100% CT. iii. *Cancer* . Because clothianidin is not expected to pose a cancer risk, a quantitative dietary exposure assessment for the purposes of assessing cancer risk was not conducted. iv. *Anticipated residue and percent crop treated
(PCT)information* . Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and information on the anticipated residue levels of pesticide residues in food and the actual levels of pesticide residues that have been measured in food. If EPA relies on such information, EPA must pursuant to FFDCA section 408(f)(1) require that data be provided 5 years after the tolerance is established, modified, or left in effect, demonstrating that the levels in food are not above the levels anticipated. For the present action, EPA will issue such data call-ins as are required by FFDCA section 408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Data will be required to be submitted no later than 5 years from the date of issuance of this tolerance. The Agency used PCT information as follows: The acute assessment is based on maximum residues of clothianidin observed in clothianidin field trials and assumes 100% crop treated. The chronic assessment is based on average residues from clothianidin field trials and also assumes 100% CT. The Agency believes that the three conditions listed in Unit III. have been met. With respect to Condition 1, PCT estimates are derived from Federal and private market survey data, which are reliable and have a valid basis. The Agency is reasonably certain that the percentage of the food treated is not likely to be an underestimation. As to Conditions 2 and 3, regional consumption information and consumption information for significant subpopulations is taken into account through EPA's computer-based model for evaluating the exposure of significant subpopulations including several regional groups. Use of this consumption information in EPA's risk assessment process ensures that EPA's exposure estimate does not understate exposure for any significant subpopulation group and allows the Agency to be reasonably certain that no regional population is exposed to residue levels higher than those estimated by the Agency. Other than the data available through national food consumption surveys, EPA does not have available information on the regional consumption of food to which clothianidin may be applied in a particular area. 2. *Dietary exposure from drinking water* . The Agency lacks sufficient monitoring data to complete a comprehensive dietary exposure analysis and risk assessment for clothianidin in drinking water. Because the Agency does not have comprehensive monitoring data, drinking water concentration estimates are made by reliance on simulation or modeling taking into account data on the environmental fate characteristics of clothianidin. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at *http://www.epa.gov/oppefed1/models/water/index.htm* . Based on the First Index Reservoir Screening Tool (FIRST) and Screening Concentration in Ground Water (SCI-GROW) models, the estimated environmental concentrations
(EECs)of clothianidin for acute exposures are estimated to be 7.29 parts per billion
(ppb)for surface water and 5.84 ppb for ground water. The EECs for chronic exposures are estimated to be 1.35 ppb for surface water and 5.84 ppb for ground water. Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For acute dietary risk assessment, the water concentration value of 7.29 ppb was used to access the contribution to drinking water. For chronic dietary risk assessment, the water concentration of value 5.84 ppb was used to access the contribution to drinking water. 3. *From non-dietary exposure* . The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). Clothianidin is currently registered for the following residential non-dietary sites: Turfgrass. EPA assessed residential exposure using the following assumptions: The following exposure scenarios were assessed for residential post-application risks: Toddlers playing on treated turf, adults performing yard work on treated turf, and adults and youths playing golf on treated turf. Additional information on residential exposure assumptions can be found at *www.regulations.gov* (Docket ID EPA-HQ-OPP-2007-0280, pages 26 through 27). 4. *Cumulative effects from substances with a common mechanism of toxicity* . Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.” Clothianidin is a member of the neonicotinoid class of pesticides and is a metabolite of another neonicotinoid, thiamethoxam. Structural similarities or common effects do not constitute a common mechanism of toxicity. Evidence is needed to establish that the chemicals operate by the same, or essentially the same sequence of major biochemical events (EPA, 2002). Although clothianidin and thiamethoxam bind selectively to insect nicotinic acetylcholine receptors (nAChR), the specific binding site(s)/receptor(s) for clothianidin, thiamethoxam, and the other neonicotinoids are unknown at this time. Additionally, the commonality of the binding activity itself is uncertain, as preliminary evidence suggests that clothianidin operates by direct competitive inhibition, while thiamethoxam is a non-competitive inhibitor. Furthermore, even if future research shows that neonicotinoids share a common binding activity to a specific site on insect nicotinic acetylcholine receptors, there is not necessarily a relationship between this pesticidal action and a mechanism of toxicity in mammals. Structural variations between the insect and mammalian nAChRs produce quantitative differences in the binding affinity of the neonicotinoids towards these receptors, which, in turn, confers the notably greater selective toxicity of this class towards insects, including aphids and leafhoppers, compared to mammals. While the insecticidal action of the neonicotinoids is neurotoxic, the most sensitive regulatory endpoint for clothianidin is based on unrelated effects in mammals, including changes in body and thymus weights, delays in sexual maturation, and still births. Additionally, the most sensitive toxicological effect in mammals differs across the neonicotinoids (e.g., testicular tubular atrophy with thiamethoxam; mineralized particles in thyroid colloid with imidaclopid). Thus, there is currently no evidence to indicate that neonicotinoids share common mechanisms of toxicity, and EPA is not following a cumulative risk approach based on a common mechanism of toxicity for the neonicotinoids. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the policy statements concerning common mechanism determinations and procedures for cumulating effects from substances found to have a common mechanism released by EPA's Office of Pesticide Programs on EPA's website at *http://www.epa.gov/pesticides/cumulative/.* Note that because clothianidin is a major metabolite of thiamethoxam, EPA has combined exposure to clothianidin resulting both from thiamethoxam use and from use of clothianidin as an active ingredient and has compared this aggregate exposure estimate to relevant endpoints for clothianidin. EPA has taken the further conservative step of assuming that, in instances where both thiamethoxam and clothianidin are registered for use on a crop, both pesticides will, in fact, be used on that crop. D. Safety Factor for Infants and Children 1. * In general* . Section 408 of FFDCA provides that EPA shall apply an additional (“10X”) tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the FQPA safety factor. In applying this provision, EPA either retains the default value of 10X when reliable data do not support the choice of a different factor, or, if reliable data are available, EPA uses a different additional FQPA safety factor value based on the use of traditional UFs and/or special FQPA safety factors, as appropriate. 2. *Prenatal and postnatal sensitivity* . In the developmental neurotoxicity study, toxicity in the offspring was observed at a lower dose level than the dose that caused toxicity in the maternal animals. Maternal effects included decreased body weights, body weight gains, and food consumption. Effects seen in the offspring included decreased body weights, body weight gains, motor activity, and acoustic startle response in the females. However, EPA determined that the degree of concern for the developmental neurotoxicity study is low and there are no residual uncertainties for prenatal and/or postnatal toxicity due to the results of the developmental neurotoxicity study because the observed effects are well characterized and there are clear NOAELs/LOAELs. In the 2-generation reproduction study, offspring toxicity (decreased body weight gains, delayed sexual maturation in males, decreased absolute thymus weights in F1 pups of both sexes, and an increase in stillbirths in both generations) was seen at a lower dose than the dose that caused parental toxicity. Based on evidence of decreased absolute and adjusted organ weights of the thymus and spleen in multiple studies in the clothianidin data base and on evidence of increased quantitative susceptibility of juvenile rats, compared to adults, in the 2-generation reproduction study to these effects. EPA has required that testing be conducted to assess immune system function in adults and in young animals following exposure during the period of organogenesis. No quantitative or qualitative susceptibility was observed in either of the developmental rat or rabbit studies. In the rat, no developmental toxicity was observed at the highest dose tested, although this dose level induced decreases in body weight gain and food consumption in the dams. In the rabbit, premature deliveries, decreased gravid uterine weights, an increase in litter incidence of a missing lobe of the lung, and a decrease in the litter average for ossified sternal centra per fetus were noted at a dose level in which maternal death, a decrease in food consumption, and clinical signs (scant feces and orange urine) were observed. Since the developmental effects observed in the rabbit study were seen in the presence of maternal toxicity, they are not considered to be qualitatively more severe than the maternal effects. 3. *Conclusion* . The exposure data for clothianidin are complete or are estimated based on data that reasonably accounts for potential exposures. The acute dietary exposure assessment is based on maximum residues of clothianidin observed in clothianidin and thiamethoxam field trials and assumes 100% CT. The chronic assessment is based on average residues from clothianidin and thiamethoxam field trials and also assumes 100% CT. For water, the highest acute estimate from conservative models was used for both the acute and the chronic dietary exposure analyses. By using these conservative assessments, acute and chronic exposures/risks will not be underestimated. The residential exposure assessment utilizes residential standard operation procedures
(SOPs)to assess post-application exposure to children as well as incidental oral ingestion by toddlers. The residential SOPs are based on reasonable worst-case assumptions and will not likely underestimate exposure/risk. These assessments are unlikely to underestimate the potential exposure to 74,800 infants and children resulting from the use of clothianidin. The toxicology data base for clothianidin, however, is not complete for FQPA purposes. A complete complement of acceptable developmental, reproduction, developmental neurotoxicity, mammalian neurotoxicity and special neurotoxicity studies are available; however, due to evidence of decreased absolute and adjusted organ weights of the thymus and spleen in multiple studies in the clothianidin database, and because juvenile rats in the two-generation reproduction study appear to be more susceptible to these effects, EPA has determined that testing should be conducted to assess immune system function in adults and in young animals following developmental exposures. Given the levels at which this testing should be conducted it could result in selection of a more protective (i.e., lower) regulatory endpoint. Due to the uncertainty with regard to potential effects on immune system function in young animals, EPA cannot conclude that there are reliable data supporting selection of a children's safety factor different from the presumptive 10X factor. Therefore, the 10X FQPA children's safety factor will be retained. This safety factor will be in the form of a database uncertainty factor to account for the lack of the testing with regard to immune system function with clothianidin. E. Aggregate Risks and Determination of Safety Safety is assessed for acute and chronic risks by comparing aggregate exposure to the pesticide to the aPAD and cPAD. The aPAD and cPAD are calculated by dividing the LOC by all applicable UFs. For linear cancer risks, EPA calculates the probability of additional cancer cases given aggregate exposure. Short-term, intermediate-term, and long-term risks are evaluated by comparing aggregate exposure to the LOC to ensure that the MOE called for by the product of all applicable UFs is not exceeded. 1. *Acute risk* . Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to clothianidin will occupy 45% of the aPAD for the population group (children 1-2 years old) receiving the greatest exposure. 2. *Chronic risk* . Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to clothianidin from food and water will utilize 16% of the cPAD for the population group (children 1-2 years old). Based on the use pattern, chronic residential exposure to residues of clothianidin is not expected. 3. *Short-term / Intermediate-term risk* . Short-term aggregate and intermediate-term aggregate exposures take into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Clothianidin is currently registered for use(s) that could result in short-term residential exposure and the Agency has determined that it is appropriate to aggregate chronic food and water and short-term exposures for clothianidin. EPA has determined that, for clothianidin, the toxicological effects are the same across oral, dermal, and inhalation routes of exposure and has selected the same endpoint and dose for short-term and intermediate-term exposure scenarios. Therefore, the exposures are simply summed (combined/aggregated) for use in risk calculations. Short- and intermediate aggregate risk estimates range from an MOE of 1,100 for toddlers (food + water + treated turf + treated soil + dermal) to 22,000 for youth golfers (food + water + post-application treated turf). The short-term and intermediate-term aggregate risks associated with the registered and proposed uses of clothianidin do not exceed the Agency's LOC for the general U.S. population or any population subgroup. 4. *Aggregate cancer risk for U.S. population* . Clothianidin has been classified as a “not likely human carcinogen.” It is not expected to pose a cancer risk. 5. *Determination of safety* . Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, or to infants and children from aggregate exposure to clothianidin residues. IV. Other Considerations A. Analytical Enforcement Methodology Adequate liquid chromotography/mass spectrometry/mass spectrometry (LC/MS/MS) methods are available for both collecting data and enforcing tolerances for clothianidin residues in plant (Bayer Methods 00552 and 109240-1) and animal (Bayer Method 00624) commodities. The validated limit of quantitation
(LOQ)for clothianidin in plant commodities is 0.010 ppm, except for wheat straw (0.020 ppm), and the validated LOQs are 0.010 ppm in milk and 0.020 ppm in animal tissues. All three of these methods have been reviewed by EPA's Analytical Chemistry Laboratory (ACL), approved for tolerance enforcement, and forwarded to FDA for inclusion in PAM Volume II. B. International Residue Limits There are no established or proposed Canadian, Mexican, or Codex maximum residue limits
(MRLs)for clothianidin residues on sugar beet commodities. V. Conclusion Therefore, the tolerance is established for residues of (E)-1-(2-chloro-1,3-thiazol-5-ylmethyl)-3-methyl-2-nitroguanidine, in or on beet, sugar, roots at 0.02 ppm, beet, sugar, molasses at 0.05 ppm and beet, sugar, dried pulp at 0.03. VI. Statutory and Executive Order Reviews This final rule establishes a tolerance under section 408(d) of FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget
(OMB)has exempted these types of actions from review under Executive Order 12866, entitled *Regulatory Planning and Review* (58 FR 51735, October 4, 1993). Because this rule has been exempted from review under Executive Order 12866, this rule is not subject to Executive Order 13211, *Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use* (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled *Protection of Children from Environmental Health Risks and Safety Risks* (62 FR 19885, April 23, 1997). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 *et seq* ., nor does it require any special considerations under Executive Order 12898, entitled *Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations* (59 FR 7629, February 16, 1994). Since tolerances and exemptions that are established on the basis of a petition under section 408(d) of FFDCA, such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act
(RFA)(5 U.S.C. 601 *et seq* .) do not apply. This final rule directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled *Federalism* (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled *Consultation and Coordination with Indian Tribal Governments* (65 FR 67249, November 6, 2000) do not apply to this rule. In addition, This rule does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995
(UMRA)(Public Law 104-4). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). VII. Congressional Review Act The Congressional Review Act, 5 U.S.C. 801 *et seq* ., generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of this final rule in the **Federal Register** . This final rule is not a “major rule” as defined by 5 U.S.C. 804(2). List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: January 22, 2008. Lois Rossi, Director, Registration Division, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: PART 180—[AMENDED] 1. The authority citation for part 180 continues to read as follows: Authority: 21 U.S.C. 321(q), 346a and 371. 2. Section 180.586 is amended by alphabetically adding the following commodities to the table in paragraph
(a)to read as follows: § 180.586 Clothianidin; tolerances for residues.
(a)* * * Commodity Parts per million Beet, sugar, dried pulp 0.03 Beet, sugar, molasses 0.05 Beet, sugar, roots 0.02 * * * * * [FR Doc. E8-1784 Filed 2-5-08; 8:45 am] BILLING CODE 6560-50-S 73 25 Wednesday, February 6, 2008 Proposed Rules OFFICE OF PERSONNEL MANAGEMENT 5 CFR Part 300 RIN 3206-AL18 Time-in-Grade Rule Eliminated AGENCY: Office of Personnel Management. ACTION: Proposed rule. SUMMARY: The Office of Personnel Management
(OPM)proposes eliminating the time-in-grade restriction on advancement to competitive service positions in the General Schedule. Currently, employees in competitive service General Schedule positions at grades 5 and above must serve 52 weeks in grade before becoming eligible for promotion to the next grade level. Abolishing the restriction would eliminate the 52-week service requirement. If the requirement is eliminated, an employee must continue to meet occupational qualification standard requirements, and any additional job-related qualification requirements, established for the position. DATES: Comments must be received on or before April 7, 2008. ADDRESSES: You may submit comments, identified by RIN number “3206-AL18,” using any of the following methods: *Federal eRulemaking Portal: http://www.regulations.gov.* Follow the instructions for submitting comments. *E-mail: employ@opm.gov.* Include “RIN 3206-AL18, Time in Grade” in the subject line of the message. *Fax:*
(202)606-2329. *Mail:* Mark Doboga, Deputy Associate Director, Center for Talent and Capacity Policy, U.S. Office of Personnel Management, Room 6551, 1900 E Street, NW., Washington, DC 20415-9700. *Hand Delivery/Courier:* Mark Doboga, Deputy Associate Director, Center for Talent and Capacity Policy, U.S. Office of Personnel Management, Room 6551, 1900 E Street, NW., Washington, DC 20415-9700. FOR FURTHER INFORMATION CONTACT: Ms. Christina Gonzales Vay by telephone
(202)606-0960; by fax
(202)606-2329; by TTY
(202)418-3134; or by e-mail *christina.vay@opm.gov.* SUPPLEMENTARY INFORMATION: Federal employees in General Schedule
(GS)competitive service positions at grades 5 and above qualify for promotions to higher grades if they meet two criteria:
(1)Have at least one year of specialized experience equivalent in difficulty to the next lower grade level or (in some cases) the equivalent education; and
(2)have service of at least 52 weeks at their current grade (known as “time in grade”). We are proposing eliminating the time-in-grade restriction as a prerequisite for promotion. The time-in-grade restriction originated in a statute called the *Whitten Amendment.* The *Whitten Amendment* was passed by Congress in 1952 during the Korean conflict. The statute was created to prevent the permanent buildup of the civil service with expanded grade levels during the Korean conflict, as had happened during World War II. The *Whitten Amendment* consisted of a series of personnel controls. The controls included a requirement to make all promotions and appointments on a temporary basis to simplify adjusting personnel actions downward at the end of the conflict; to conduct an annual survey of positions to assure each was properly graded; and to implement the time-in-grade restrictions to prevent excessively rapid promotions of Federal employees in GS competitive and excepted service positions. Before the *Whitten Amendment* expired, Congress sought a review by the predecessor of OPM, the Civil Service Commission (Commission), to determine whether to retain any of the provisions in the amendment. The Commission reported that the time-in-grade restriction for competitive service GS positions had been placed in regulation and would continue even if the *Whitten Amendment* expired. The law expired September 14, 1978, and time in grade continues in regulation for competitive service GS positions. On June 14, 1995 (59 **Federal Register**
(FR)30717) and January 10, 1996 (60 FR 2546), we published proposals to eliminate time in grade. Because almost 12 years have passed since publication of the first proposal, we are providing interested individuals another opportunity to comment. Reasons for Proposed Elimination We propose eliminating time in grade for the following reasons: — *Grade Control No Longer Needed.* When the *Whitten Amendment* was first enacted, no effective means existed to prevent employees from advancing quickly through the grades. Today, Governmentwide qualification standards, established by OPM, are in place for competitive service GS positions. (The OPM Operating Manual *Qualification Standards for General Schedule Positions* is available on the OPM Web site ( *http://www.opm.gov* )). Eliminating the time-in-grade restriction will not have an impact on how agencies now use qualification standards to evaluate candidates. Currently, candidates may demonstrate possession of either experience of at least one year (acquired through any paid or unpaid work or non-work setting or situation in which the experience enabled the individual to acquire the required competencies/knowledge, skills, or abilities) and/or the appropriate level of education as outlined in the OPM Operating Manual. Agencies must continue to ensure that candidates for promotion possess the required level of experience at the appropriate grade level (as defined in the classification standards) and/or meet the education requirements. In addition to using OPM qualification standards and/or education levels, agencies also have the discretion to establish additional requirements beyond the OPM qualification standards that employees must meet for promotions. Many have done so. Examples of requirements include the specific level of performance to meet, possession of specific job-related competencies/knowledge, skills, and abilities, evidence that higher level duties exist, and/or availability of funds. Eliminating the time-in-grade requirement will not eliminate the agency's determination on whether a candidate is qualified to perform the essential higher level duties. Rather, elimination of the 52-week time in grade waiting period reinforces the principle that promotions are based on an individual's ability to perform the requirements of the position (i.e., merit) not longevity. — *Performance Management Accountability Continues.* Managers are responsible for ensuring there are sound performance management criteria based on job-related factors at the appropriate levels of proficiency when considering promotions of employees to higher graded duties. Eliminating the time-in-grade requirement will help dispel the myth that promotion automatically follows a set period of time spent in a particular grade, and instead emphasizes the importance of the qualification requirements, as well as the quality and level of performance needed to succeed at the next higher grade level. — *Safeguards Are Now in Place.* When time in grade expired in the *Whitten Amendment,* the merit systems principles (title 5, United States Code (U.S.C.), section 2301) and prohibited personnel practices (5 U.S.C 2302) had not been enacted as statutory provisions or codified in the United States Code. Alleged violations may be pursued and investigated and corrective or disciplinary actions may be warranted. — *Inconsistencies Exist Among Federal Employees.* Time in grade applies to competitive service GS employees, but does not apply to competitive service employees under other pay plans, including employees in Wage Grade positions. Time in grade does not apply to those competitive service GS employees who apply for other competitive service positions through a competitive examination. The time-in-grade restriction does not apply to excepted service GS employees, although individual agencies can, at its discretion, require time in grade for their excepted service employees. This disparate treatment of employees under varying appointments and pay plans highlights the inequities of retaining time in grade. Eliminating time in grade enables any Federal competitive service GS employee (regardless of current occupation or grade), who meets the qualification standards for a particular position, to become eligible for promotion to a competitive service GS position. This can be done through a competitive examination or under an agency's internal merit promotion procedures, as applicable. Elimination also gives agencies the flexibility to continue requiring employees to meet a specified amount of time in their current grade, regardless of their qualifications. We do not believe time-in-grade elimination will lead to a large number of excessively rapid promotions Governmentwide. Over the years, many demonstration projects have waived the use of time in grade, especially when pay banding was incorporated. In these cases, agencies imposed their own internal policies regarding promotions which were similar to time in grade. In the China Lake demonstration project, for example, OPM data indicate workers progressed through the bands at a slower rate, at least initially, than people in the GS pay scale. (To illustrate, an employee in a competitive service GS position can sometimes receive a pay raise, a within-grade increase, and a promotion in the same year and do so again in consecutive years, whereas a more disciplined pay system makes movement through the band less automatic and rapid.) Moreover, we are not aware of any widespread abuses concerning those positions that do not have a time-in-grade requirement. — *Labor Market Challenges Exist.* Competitive pressures in the labor market challenge the Federal Government's ability to recruit, select, and retain highly qualified employees. These pressures did not exist during the time of the *Whitten Amendment.* Applying time in grade sometimes results in eliminating from consideration candidates who are in fact able to successfully perform the essential duties of the position. The merit system requires determining the qualifications of individuals; identifying appropriate recruitment sources; ensuring there is representation of all segments of society in the workforce; determining that selection and advancement are based solely on relative competencies/knowledge, skills, and ability; and ensuring that all receive equal opportunity through fair and open competition. Agencies already must meet these requirements; time in grade does not enhance agency ability to recruit, select, and retain the broadest pool possible of qualified Federal employees. In fact, time in grade can limit the pool of possible qualified candidates. The proposal to eliminate time in grade is consistent with upholding merit principles, and has the added benefit of helping agencies recruit and hire in tight labor market conditions. — *Agencies Gain Flexibility.* Eliminating the time-in-grade requirement will simplify OPM and agency operations. It will remove administrative burdens because agencies will no longer need OPM approval of training agreements that provide for consecutive accelerated promotions. Also, agencies will be able to implement flexibilities, such as pay banding or new ideas proposed in demonstration projects, without being required to obtain approval from OPM to waive time in grade. Regulatory Flexibility Act I certify that this regulation will not have a significant economic impact on a substantial number of small entities because it affects only certain Federal employees. E.O. 12866, Regulatory Review This rule has been reviewed by the Office of Management and Budget in accordance with Executive Order 12866. List of Subjects in 5 CFR Part 300 Freedom of information, Government employees, Reporting and recordkeeping requirements, Selective Service System. U.S. Office of Personnel Management. Linda M. Springer, Director. Accordingly, OPM proposes to amend 5 CFR part 300 as follows: PART 300—EMPLOYMENT (GENERAL) 1. Revise the authority citation for part 300 to read as follows: Authority: 5 U.S.C. 552, 3301, 3302; E.O. 10577, 3 CFR, 1954-1958 Comp., page 218, unless otherwise noted. Secs. 300.101 through 300.104 also issued under 5 U.S.C. 7201, 7204, 7701; E.O. 11478, 3 CFR, 1966-1970 Comp., page 803. Sec. 300.301 also issued under 5 U.S.C. 1104 and 3341. Secs. 300.401 through 300.408 also issued under 5 U.S.C. 1302(c), 2301, and 2302. Secs. 300.501 through 300.507 also issued under 5 U.S.C. 1103(a)(5). Subpart F—[Removed and Reserved] 2. Remove and reserve subpart F, consisting of §§ 300.601 through 300.606. [FR Doc. E8-2122 Filed 2-5-08; 8:45 am] BILLING CODE 6325-38-P DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 100 [Docket No. USCG-2008-0031] RIN 1625-AA08 Regattas and Marine Parades; Great Lakes Annual Marine Events AGENCY: Coast Guard, DHS. ACTION: Notice of proposed rulemaking. SUMMARY: This proposed rule proposes restrictions on vessel movement in portions of the Calumet Sag Channel and the Little Calumet River during the annual Southland Regatta. The Southland Regatta is a university rowing race that will be held annually during the first weekend of November. This proposed rule is intended to ensure safety of life on the navigable waters immediately prior to, during, and immediately after regattas or marine parades. DATES: Comments and related materials must reach the Coast Guard on or before May 6, 2008. ADDRESSES: You may submit comments identified by Coast Guard docket number USCG-2008-0031 to the Docket Management Facility at the U.S. Department of Transportation. To avoid duplication, please use only one of the following methods:
(1)*Online: http://www.regulations.gov.*
(2)*Mail:* Docket Management Facility (M-30), U.S. Department of Transportation, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590-0001.
(3)*Hand delivery:* Room W12-140 on the Ground Floor of the West Building, 1200 New Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The telephone number is 202-366-9329.
(4)*Fax:* 202-493-2251. FOR FURTHER INFORMATION CONTACT: CWO Brad Hinken, Prevention Department, Coast Guard Sector Lake Michigan, Milwaukee, WI at
(414)747-7154. If you have questions on viewing or submitting material to the docket, call Renee V. Wright, Program Manager, Docket Operations, at
(202)366-9826. SUPPLEMENTARY INFORMATION: I. Public Participation and Request for Comments We encourage you to participate in this rulemaking by submitting comments and related materials. All comments received will be posted, without change, to *http://www.regulations.gov* and will include any personal information you have provided. We have an agreement with the Department of Transportation
(DOT)to use the Docket Management Facility. Please see DOT's “Privacy Act” paragraph below. A. Submitting Comments If you submit a comment, please include the docket number for this rulemaking (USCG-2008-0031), indicate the specific section of this document to which each comment applies, and give the reason for each comment. We recommend that you include your name, mailing address, and an e-mail address or other contact information in the body of your document to ensure that you can be identified as the submitter. This also allows us to contact you in the event further information is needed or if there are questions. For example, if we cannot read your submission due to technical difficulties and you cannot be contacted, your submission may not be considered. You may submit your comments and material by electronic means, mail, fax, or delivery to the Docket Management Facility at the address under ADDRESSES ; but please submit your comments and material by only one means. If you submit them by mail or delivery, submit them in an unbound format, no larger than 8 1/2 by 11 inches, suitable for copying and electronic filing. If you submit them by mail and would like to know that they reached the Facility, please enclose a stamped, self-addressed postcard or envelope. We will consider all comments and material received during the comment period. We may change this proposed rule in view of them. B. Viewing Comments and Documents To view comments, as well as documents mentioned in this preamble as being available in the docket, go to *http://www.regulations.gov* at any time, click on “Search for Dockets,” and enter the docket number for this rulemaking (USCG-2008-0031) in the Docket ID box, and click enter. You may also visit the Docket Management Facility in Room W12-140 on the ground floor of the DOT West Building, 1200 New Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. C. Privacy Act Anyone can search the electronic form of all comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review the Department of Transportation's Privacy Act Statement in the **Federal Register** published on April 11, 2000 (65 FR 19477), or you may visit *http://DocketsInfo.dot.gov.* SUPPLEMENTARY INFORMATION: Public Meeting We do not now plan to hold a public meeting. But you may submit a request for a meeting by writing to Commander, Coast Guard Sector Lake Michigan at the address under ADDRESSES explaining why one would be beneficial. If we determine that one would aid this rulemaking, we will hold one at a time and place announced by a later notice in the **Federal Register** . Background and Purpose This proposed rule will add a section to 33 CFR part 100 that will place restrictions on the portions of the Calumet Sag Channel and the Little Calumet River during the annual Southland Regatta. The Southland Regatta is a university rowing race that will be held annually during the first weekend of November. Discussion of Proposed Rule This proposed rule is intended to ensure safety of life on the navigable waters immediately prior to, during, and immediately after the Southland Regatta. This proposed rule will establish restrictions upon and control the movement of vessels through a portion of the Calumet Sag Channel and the Little Calumet River immediately prior to, during, and immediately after the Southland Regatta. This proposed rule would regulate all waters of the Calumet Sag Channel from the South Halstead Street Bridge at 41°39′27″ N, 087°38′29″ W; to the Crawford Avenue Bridge at 41°39′05″ N, 087°43′08″ W; and the Little Calumet River from the Ashland Avenue Bridge at 41°39′07″ N, 087°39′38″ W; to the junction of the Calumet Sag Channel. (DATUM: NAD 83). The Captain of the Port will issue a notice of enforcement of the special local regulations established by this section, by all appropriate means, to the affected segments of the public. Such means of notification will include, but is not limited to, Broadcast Notice to Mariners and Local Notice to Mariners. Regulatory Evaluation This proposed rule is not a “significant regulatory action” under section 3(f) of Executive Order 12866, Regulatory Planning and Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. The Office of Management and Budget has not reviewed it under that Order. We expect the economic impact of this proposed rule to be so minimal that a full Regulatory Evaluation is unnecessary. The Coast Guard's use of this special local regulation will be periodic, of short duration, and designed to minimize the impact on navigable waters. This regulation will only be enforced immediately before, during, and immediately after the time the marine events occur. Furthermore, this special local regulation has been designed to allow vessels to transit unrestricted to portions of the waterways not affected by the special local regulation. The Coast Guard expects insignificant adverse impact to mariners from the activation of this special local regulation. Small Entities Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have considered whether this proposed rule would have a significant economic impact on a substantial number of small entities. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this proposed rule would not have a significant economic impact on a substantial number of small entities. This proposed rule would affect the following entities, some of which might be small entities: The owners and operators of vessels intending to transit or anchor on the Calumet Sag Channel and the Little Calumet River on the first Saturday of November. This special local regulation will not have a significant economic impact on a substantial number of small entities for the following reasons: This proposed rule would be in effect for short periods of time and only once per year; is designed to allow traffic to pass safely around the zone whenever possible; and allows vessels to pass through the zones with the permission of the Captain of the Port. If you think that your business, organization, or governmental jurisdiction qualifies as a small entity and that this proposed rule would have a significant economic impact on it, please submit a comment (see ADDRESSES ) explaining why you think it qualifies, and how and to what degree this proposed rule would economically affect it. Assistance for Small Entities Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this proposed rule so that they can better evaluate its effects on them and participate in the rulemaking. If the proposed rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact CWO Brad Hinken, Prevention Department, Coast Guard Sector Lake Michigan, Milwaukee, WI at
(414)747-7154. The Coast Guard will not retaliate against small entities that question or complain about this proposed rule or any policy or action of the Coast Guard. Collection of Information This proposed rule calls for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). Federalism A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on State or local governments and would either preempt State law or impose a substantial direct cost of compliance on them. We have analyzed this proposed rule under that Order and have determined that it does not have implications for federalism. Unfunded Mandates Reform Act The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 or more in any one year. Though this proposed rule will not result in such expenditure, we nevertheless discuss its effects elsewhere in this preamble. Taking of Private Property This proposed rule will not effect the taking of private property or otherwise have taking implications under Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights. Civil Justice Reform This proposed rule meets applicable standards in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden. Protection of Children We have analyzed this proposed rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. This proposed rule is not an economically significant rule and does not create an environmental risk to health or safety that may disproportionately affect children. Indian Tribal Governments The Coast Guard recognizes the treaty rights of Native American Tribes. Moreover, the Coast Guard is committed to working with Tribal Governments to implement local policies and to mitigate tribal concerns. We have determined that these regulations and fishing rights protection need not be incompatible. We have also determined that this proposed rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. Nevertheless, Indian Tribes that have questions concerning the provisions of this proposed rule or options for compliance are encourage to contact the point of contact listed under FOR FURTHER INFORMATION CONTACT . Energy Effects We have analyzed this proposed rule under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. We have determined that it is not a “significant energy action” under that order because it is not a “significant regulatory action” under Executive Order 12866 and is not likely to have a significant adverse effect on the supply, distribution, or use of energy. The Administrator of the Office of Information and Regulatory Affairs has not designated it as a significant energy action. Therefore, it does not require a Statement of Energy Effects under Executive Order 13211. Technical Standards The National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note) directs agencies to use voluntary consensus standards in their regulatory activities unless the agency provides Congress, through the Office of Management and Budget, with an explanation of why using these standards would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (e.g., specifications of materials, performance, design, or operation; test methods; sampling procedures; and related management systems practices) that are developed or adopted by voluntary consensus standards bodies. This proposed rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards. Environment We have analyzed this proposed rule under Commandant Instruction M16475.lD and Department of Homeland Security Management Directive 5100.1, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969
(NEPA)(42 U.S.C. 4321-4370f), and have made a preliminary determination that there are no factors in this case that would limit the use of a categorical exclusion under section 2.B.2 of the Instruction. Therefore, we believe that this proposed rule should be categorically excluded, under figure 2-1, paragraph 34(h) of the Instruction, from further environmental documentation. This proposed rule would establish a special local regulation issued in conjunction with a regatta or marine parade, and as such is covered by this paragraph. A preliminary “Environmental Analysis Check List” and a preliminary “Categorical Exclusion Determination” are available in the docket where indicated under ADDRESSES . Comments on this section will be considered before we make the final decision on whether the proposed rule should be categorically excluded from further environmental review. We seek any comments or information that may lead to the discovery of a significant environmental impact from this proposed rule. List of Subjects in 33 CFR Part 100 Marine safety, Navigation (water), Reporting and recordkeeping requirements, and Waterways. For the reasons discussed in the preamble, the Coast Guard proposes to amend 33 CFR part 100 as follows: PART 100—SAFETY OF LIFE ON NAVIGABLE WATERS 1. The authority citation for part 100 continues to read as follows: Authority: 33 U.S.C. 1233. 2. Add § 100.910 to read as follows: § 100.910 Southland Regatta; Blue Island, IL.
(a)*Regulated Area.* A regulated area is established to include all waters of the Calumet Sag Channel from the South Halstead Street Bridge at 41°39′27″ N, 087°38′29″ W; to the Crawford Avenue Bridge at 41°39′05″ N, 087°43′08″ W; and the Little Calumet River from the Ashland Avenue Bridge at 41°39′07″ N, 087°39′38″ W; to the junction of the Calumet Sag Channel. (DATUM: NAD 83).
(b)*Special Local Regulations.* The regulations of § 100.901 apply. No vessel may enter, transit through, or anchor within the regulated area without the permission of the Coast Guard Patrol Commander.
(c)*Effective Period.* This section is effective annually on the Saturday immediately prior to the first Sunday of November, from 3 p.m. until 5 p.m.; and the first Sunday of November, from 9 a.m. until 5 p.m. Dated: January 17, 2008. J.R. Castillo, Captain, U.S. Coast Guard, Commander, Ninth Coast Guard District, Acting. [FR Doc. E8-2165 Filed 2-5-08; 8:45 am] BILLING CODE 4910-15-P DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 165 [Docket No. USCG-2007-0143] RIN 1625-AA00 Safety Zone; Oceanside Harbor, California AGENCY: Coast Guard, DHS. ACTION: Notice of proposed rulemaking. SUMMARY: The Coast Guard proposes a temporary safety zone within the navigable waters of the Pacific Ocean in Oceanside Harbor, California for the Ford Ironman 70.3 California Triathlon. This temporary safety zone is necessary to provide for the safety of the participants (swimmers), crew, spectators, and other vessels and users of the waterway. Persons and vessels are prohibited from entering into, transiting through, or anchoring within this safety zone unless authorized by the Captain of the Port or his designated representative. DATES: Comments and related material must reach the Coast Guard on or before March 3, 2008. ADDRESSES: You may submit comments identified by Coast Guard docket number USCG-2007-0143 to the Docket Management Facility at the U.S. Department of Transportation. To avoid duplication, please use only one of the following methods:
(1)*Online: http://www.regulations.gov.*
(2)*Mail:* Docket Management Facility (M-30), U.S. Department of Transportation, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590-0001.
(3)*Hand delivery:* Room W12-140 on the Ground Floor of the West Building, 1200 New Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The telephone number is 202-366-9329.
(4)*Fax:* 202-493-2251. FOR FURTHER INFORMATION CONTACT: If you have questions on this proposed rule, call Petty Officer Kristen Beer, Waterways Management, U.S. Coast Guard Sector San Diego at
(619)278-7233. If you have questions on viewing or submitting material to the docket, call Renee V. Wright, Program Manager, Docket Operations, telephone 202-366-9826. SUPPLEMENTARY INFORMATION: Public Participation and Request for Comments We encourage you to participate in this rulemaking by submitting comments and related materials. All comments received will be posted, without change, to *http://www.regulations.gov* and will include any personal information you have provided. We have an agreement with the Department of Transportation
(DOT)to use the Docket Management Facility. Please see DOT's “Privacy Act” paragraph below. Submitting Comments If you submit a comment, please include the docket number for this rulemaking (USCG-2007-0143), indicate the specific section of this document to which each comment applies, and give the reason for each comment. We recommend that you include your name and a mailing address, an e-mail address, or a phone number in the body of your document so that we can contact you if we have questions regarding your submission. You may submit your comments and material by electronic means, mail, fax, or delivery to the Docket Management Facility at the address under ADDRESSES ; but please submit your comments and material by only one means. If you submit them by mail or delivery, submit them in an unbound format, no larger than 8 1/2 by 11 inches, suitable for copying and electronic filing. If you submit them by mail and would like to know that they reached the Facility, please enclose a stamped, self-addressed postcard or envelope. We will consider all comments and material received during the comment period. We may change this proposed rule in view of them. Viewing Comments and Documents To view comments, as well as documents mentioned in this preamble as being available in the docket, go to *http://www.regulations.gov* at any time. Enter the docket number for this rulemaking (USCG-2007-0143) in the box under “Search”, and click “Go”. You may also visit the Docket Management Facility in Room W12-140 on the ground floor of the DOT West Building, 1200 New Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. Privacy Act Anyone can search the electronic form of all comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review the Department of Transportation's Privacy Act Statement in the **Federal Register** published on April 11, 2000 (65 FR 19477), or you may visit *http://DocketsInfo.dot.gov.* Public Meeting We do not now plan to hold a public meeting. But you may submit a request for one to the Docket Management Facility at the address under ADDRESSES explaining why one would be beneficial. If we determine that one would aid this rulemaking, we will hold one at a time and place announced by a later notice in the **Federal Register** . Background and Purpose The Ford Ironman 70.3 California Triathlon is sponsored by North American Sports, Inc. The proposed event would consist of twenty-two hundred (2,200) participants. The waterside swim course begins in South Oceanside Harbor, with a turn-around in the vicinity of Oceanside Channel buoy 3, thence to the Oceanside Harbor Launch Ramp for a transition to the bicycle portion of the event. The 1.2 mile swim course would require a safety zone while swimmers are on the course, thus restricting all vessel traffic within Oceanside Harbor for three
(3)hours. There will be six
(6)to eight
(8)kayaks, two
(2)to four
(4)paddle boards, fifteen
(15)surfboards, and two
(2)motorboats provided by the sponsor to enforce the safety zone. Discussion of Proposed Rule The Coast Guard proposes to establish one
(1)safety zone that will be enforced from 6:30 a.m. to 9:30 p.m. on Saturday, March 29, 2008 for the Ford Ironman 70.3 California Triathlon. This temporary safety zone is necessary for the safety of participant swimmers and the staff members of the race and will affect use of the waterway during the period of the event. The event will last for one day. The event is anticipated to draw fairly large crowds and the safety zone is established to ensure their safety. The limits of this temporary safety zone are the waters of Oceanside Harbor, California, including the entrance channel. The Coast Guard will enforce the safety zone. The Coast Guard may be assisted by other federal, state, or local agencies, including the Coast Guard Auxiliary. Section 165.23 of Title 33, Code of Federal Regulations, prohibits any unauthorized person or vessel from entering or remaining in a safety zone. Vessels or persons violating this section will be subject to both criminal and civil penalties. Regulatory Evaluation This proposed rule is not a “significant regulatory action” under section 3(f) of Executive Order 12866, Regulatory Planning and Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. The Office of Management and Budget has not reviewed it under that Order. We expect the economic impact of this proposed rule to be so minimal that a full Regulatory Evaluation is unnecessary. This determination is based on the size and location of the safety zone within the water. Commercial and recreational vessels will not be allowed to transit through the designated safety zone during the specified times. Small Entities Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have considered whether this proposed rule would have a significant economic impact on a substantial number of small entities. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this proposed rule would not have a significant economic impact on a substantial number of small entities. The factual basis for this certification is as follows:
(1)This proposed rule would affect the following entities, some of which might be small entities: the owners or operators of vessels intending to transit or anchor in the portion of the Oceanside Harbor, California and the entrance channel from 6:30 a.m. to 9:30 a.m. on March 29, 2008.
(2)This safety zone would not have a significant economic impact on a substantial number of small entities for the following reasons. This rule would be in effect for only three
(3)hours early in the day when vessel traffic is low. Although the safety zone would apply to the entire width of the harbor, traffic would be allowed to pass through the zone with the permission of the Coast Guard patrol commander. Before the effective period, we would publish local notice to mariners
(LNM)before the safety zone is enforced. If you think that your business, organization, or governmental jurisdiction qualifies as a small entity and that this rule would have a significant economic impact on it, please submit a comment (see ADDRESSES ) explaining why you think it qualifies and how and to what degree this rule would economically affect it. Assistance for Small Entities Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this proposed rule so that they can better evaluate its effects on them and participate in the rulemaking. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact Petty Officer Kristen Beer, Waterways Management, U. S. Coast Guard Sector San Diego at
(619)278-7233. The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard. Collection of Information This proposed rule would call for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520. Federalism A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on State or local governments and would either preempt State law or impose a substantial direct cost of compliance on them. We have analyzed this proposed rule under that Order and have determined that it does not have implications for federalism. Unfunded Mandates Reform Act The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 or more in any one year. Though this proposed rule would not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble. Taking of Private Property This proposed rule would not effect a taking of private property or otherwise have taking implications under Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights. Civil Justice Reform This proposed rule meets applicable standards in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden. Protection of Children We have analyzed this proposed rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. This rule is not an economically significant rule and would not create an environmental risk to health or risk to safety that might disproportionately affect children. Indian Tribal Governments This proposed rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it would not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. Energy Effects We have analyzed this proposed rule under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. We have determined that it is not a “significant energy action” under that order because it is not a “significant regulatory action” under Executive Order 12866 and is not likely to have a significant adverse effect on the supply, distribution, or use of energy. The Administrator of the Office of Information and Regulatory Affairs has not designated it as a significant energy action. Therefore, it does not require a Statement of Energy Effects under Executive Order 13211. Technical Standards The National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note) directs agencies to use voluntary consensus standards in their regulatory activities unless the agency provides Congress, through the Office of Management and Budget, with an explanation of why using these standards would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (e.g., specifications of materials, performance, design, or operation; test methods; sampling procedures; and related management systems practices) that are developed or adopted by voluntary consensus standards bodies. This proposed rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards. Environment We have analyzed this proposed rule under Commandant Instruction M16475.lD and Department of Homeland Security Management Directive 5100.1, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969
(NEPA)(42 U.S.C. 4321-4370f), and have made a preliminary determination that this action is not likely to have a significant effect on the human environment. A preliminary “Environmental Analysis Check List” supporting this preliminary determination is available in the docket where indicated under ADDRESSES . We seek any comments or information that may lead to the discovery of a significant environmental impact from this proposed rule. List of Subjects in 33 CFR Part 165 Harbors, Marine safety, Navigation (water), Reporting and recordkeeping requirements, Security measures, and Waterways. Words of Issuance and Proposed Regulatory Text For the reasons discussed in the preamble, the Coast Guard proposes to amend 33 CFR part 165 as follows: PART 165—REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS 1. The authority citation for part 165 continues to read as follows: Authority: 33 U.S.C. 1226, 1231; 46 U.S.C. Chapter 701; 50 U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Pub. L. 107-295; 116 Stat. 2064; Department of Homeland Security Delegation No. 0170.1. 2. Add new § 165.T11-002 to read as follows: § 165.T11-002 Safety zone; Oceanside Harbor, California.
(a)*Location.* The Coast Guard proposes establishing a temporary safety zone for the Bluewater Ford Ironman 70.3 California Triathlon. The limits of this temporary safety zone are the waters of Oceanside Harbor, California, including the entrance channel.
(b)*Effective Period.* This section is effective from 6:30 a.m. to 9:30 a.m. on March 29, 2008.
(c)*Regulations.* Entry into, transit through or anchoring within this safety zone is prohibited unless authorized by the Captain of the Port of San Diego or his designated on-scene representative. Mariners requesting permission to transit through the safety zone may request authorization to do so from the Patrol Commander (PATCOM). The PATCOM may be contacted on VHF-FM Channel 16. Dated: January 25, 2008. C.V. Strangfeld, Captain, U.S. Coast Guard, Captain of the Port, San Diego. [FR Doc. E8-2167 Filed 2-5-08; 8:45 am] BILLING CODE 4910-15-P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 81 [EPA-HQ-OAR-2008-0006; FRL-8525-9] Final 8-Hour Ozone National Ambient Air Quality Standards Designations for the Early Action Compact Areas AGENCY: Environmental Protection Agency (EPA). ACTION: Proposed rule. SUMMARY: The EPA is proposing to designate 13 Early Action Compact
(EAC)Areas as attainment for the 8-hour ozone National Ambient Air Quality Standard (NAAQS). The EAC areas agreed to reduce ground-level ozone pollution earlier than the Clean Air Act
(CAA)required and to demonstrate attainment with the 8-hour ozone NAAQS by December 31, 2007. The States in which these 13 areas are located have submitted quality-assured data indicating that the areas are in attainment for the 8-hour ozone NAAQS based on ambient air monitoring data from 2005, 2006 and 2007. In addition, the EPA plans to revoke the ­1-hour ozone NAAQS for each of these areas one year after the effective date of the designations for the 8-hour ozone NAAQS, and we would modify the 1-hour ozone NAAQS tables in the regulations to reflect the application of the revocation. DATES: Comments must be received on or before February 21, 2008. ADDRESSES: Submit your comments, identified by Docket ID no. EPA-HQ-OAR-2008-0006, by one of the following methods: • *www.regulations.gov:* Follow the on-line instructions for submitting comments. • *E-mail: A-and-R-Docket@epa.gov* . • *Fax:*
(202)566-1741. • *Mail:* Docket EPA-HQ-OAR-2008-0006, Environmental Protection Agency, Mailcode: 6102T, 1200 Pennsylvania Avenue, Northwest, Washington, DC 20460. Please include two copies. • *Hand Delivery:* Deliver your comments to: Air Docket, Environmental Protection Agency, 1301 Constitution Avenue, NW., Room 3334, Washington, DC 20004, Attention: Docket ID No. EPA-HQ-OAR-2008-0006. Such deliveries are only accepted during the Docket's normal hours of operation, and special arrangements should be made for deliveries of boxed information. *Instructions:* Direct your comments to Docket ID No. EPA-HQ-OAR-2008-0006. The EPA's policy is that all comments received will be included in the public docket without change and may be made available online at *www.regulations.gov* , including any personal information provided, unless the comment includes information claimed to be Confidential Business Information
(CBI)or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through *www.regulations.gov* or e-mail. The *www.regulations.gov* Web site is an “anonymous access” system, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an e-mail comment directly to EPA without going through *www.regulations.gov* , your ­e-mail address will be automatically captured and included as part of the comment that is placed in the public docket and made available on the Internet. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment with any disk or CD-ROM you submit. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses. For further information about EPA's public docket visit the EPA Docket Center homepage at *http://www.epa.gov/epahome/dockets.htm* . *Docket:* All documents in the docket are listed in the *www.regulations.gov* index. Although listed in the index, some information is not publicly available, e.g., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, will be publicly available only in hard copy. Publicly available docket materials are available either electronically in *www.regulations.gov* or in hard copy at the EPA Docket Center, EPA/DC, EPA West, Room 3334, 1301 Constitution Avenue, NW., Washington, DC. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. A reasonable fee may be charged for copying. The telephone number for the Public Reading Room is
(202)566-1744, and the telephone number for the Air Docket is
(202)566-1742. FOR FURTHER INFORMATION CONTACT: Ms. Barbara Driscoll, Office of Air Quality Planning and Standards, U.S. Environmental Protection Agency, Mail Code C539-04, Research Triangle Park, NC 27711, phone number
(919)541-1051 or by e-mail at: *driscoll.barbara@epa.gov* or Mr. David Cole, Office of Air Quality Planning and Standards, U.S. Environmental Protection Agency, Mail Code C304-05, Research Triangle Park, NC 27711, phone number
(919)541-5565 or by ­e-mail at: *cole.david@epa.gov* . SUPPLEMENTARY INFORMATION: I. General Information A. Does This Action Apply to Me? This proposed action applies only to the 13 EAC areas identified in section IV, Table 1, below that have deferred designations for the 8-hour ozone NAAQS until April 15, 2008. Additionally, this action notes that in the final rule, EPA plans to take the ministerial action of revising the CFR to reflect the effective date of the nonattainment designation for the Denver EAC area, which was designated nonattainment on November 20, 2007. B. How Is This Document Organized? The information presented in this preamble is organized as follows: Outline I. General Information A. Does This Action Apply to Me? B. How is This Document Organized? II. What Is the Purpose of This Document? III. What Action Has EPA Taken to Date for Early Action Compact Areas? IV. What Is the Proposed Action for the 13 Early Action Compact Areas? V. Statutory and Executive Order Reviews A. Executive Order 12866: Regulatory Planning and Review B. Paperwork Reduction Act C. Regulatory Flexibility Act D. Unfunded Mandates Reform Act E. Executive Order 13132: Federalism F. Executive Order 13175: Consultation and Coordination With Indian Tribal Governments G. Executive Order 13045: Protection of Children From Environmental Health and Safety Risks H. Executive Order 13211: Actions That Significantly Affect Energy Supply, Distribution, or Use I. National Technology Transfer Advancement Act J. Executive Order 12898: Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations II. What Is the Purpose of This Document? The purpose of this document is to propose designating 13 EAC areas as attainment for the 8-hour ozone NAAQS, as they have met all the milestones of the EAC program and demonstrated that they were in attainment with the 8-hour ozone NAAQS by December 31, 2007. At the time we take final action on this proposal we also plan to take the ministerial action of revising Section 81.306 to reflect the nonattainment designation for the Denver EAC area. On September 21, 2007, EPA extended the deferred effective date for the Denver EAC area from September 14, 2007 to November 20, 2007, while settlement negotiations were taking place, and to allow time for an evaluation of the Denver EAC's 8-hour ozone air quality for 2005, 2006 and the first three quarters of 2007. Evaluation of the data indicated a violation of the 8-hour ozone standard, therefore, EPA took no action to further defer the effective date of designation and Denver's nonattainment designation became effective on November 20, 2007. In addition, the EPA plans to revoke the 1-hour ozone NAAQS for each of these EAC areas one year after the effective date of the designations for the 8-hour ozone NAAQS, and we would modify the 1-hour ozone NAAQS tables in 40 CFR part 81 to reflect the application of the revocation. This action was taken for all other areas of the country except the EACs on August 3, 2005 (70 FR 44470). III. What Action Has EPA Taken to Date for Early Action Compact Areas? Currently, there are 28 areas remaining in the EAC program. Of those 28 areas, 13 had their designations deferred for the ozone 8-hour NAAQ until April 15, 2008 (71 FR 69022). 1 The other 15 areas were designated attainment in April 2004, with an effective date of June 15, 2004. These areas have remained in the program in order to continue improving their local air quality. For discussions on EPA's actions to date with respect to deferring the effective date of nonattainment designations for certain areas of the country that are participating in the EAC program and Denver specifically please refer to the **Federal Register** dated June 28, 2007 (72 FR 35356) and September 21, 2007 (72 FR 53952). In addition, EPA's April 30, 2004, air quality designation rule (69 FR 23858) provides a description of the compact area approach, the requirements for areas participating in the compact and the impacts of the compact on those areas. 1 As noted previously, we also initially deferred the nonattainment designation for the Denver EAC area, but the nonattainment designation for the Denver EAC area became effective November 20, 2007. You may find copies of all State reports at *http://www.epa.gov/ttn/naaqs/ozone/eac/* . IV. What Is the Proposed Action for the 13 Early Action Compact Areas? The 13 EAC areas with deferred designations for the 8-hour NAAQS, had to meet one final milestone which was to demonstrate attainment with the ­8-hour ozone NAAQS by December 31, 2007. Each of these EAC areas met all of the earlier milestones of the EAC program and the States in which the areas are located have now submitted quality-assured data demonstrating that the areas attained the 8-hour ozone NAAQS based on air quality data from 2005, 2006 and 2007. Therefore, EPA is proposing to designate these 13 areas as attainment for the 8-hour ozone standard. Table 1 provides the 8-hour ozone design values for each of the 13 EAC areas based on the 2005-2007 air quality data. Table 1.—8-Hour Ozone Design Values for Compact Areas Proposed To Be Designated Attainment for 8-Hour Ozone NAAQS Effective April 15, 2008 *Note:* Name of designated 8-hour ozone deferred nonattainment areas is in parentheses. State Compact area (designated area) Counties proposed to be designated attainment effective April 15, 2008 8-hour ozone design value (parts per million) EPA Region 3 VA Northern Shenandoah Valley Region (Frederick County, VA), adjacent to Washington, DC-MD-VA Winchester City, Frederick County 0.073 VA Roanoke area (Roanoke, VA) Roanoke County, Botetourt County, Roanoke City, Salem City 0.076 MD Washington County (Washington County, Hagerstown, MD), adjacent to Washington, DC-MD-VA Washington County 0.079 WV The Eastern Pan Handle Region (Berkeley & Jefferson Counties, WV), Martinsburg area Berkeley County, Jefferson County 0.075 EPA Region 4 NC Unifour (Hickory-Morganton-Lenoir, NC) Catawba County, Alexander County, Burke County (part), Caldwell County
(part)0.078 NC Triad (Greensboro-Winston-Salem-High Point, NC) Randolph County, Forsyth County, Davie County, Alamance County, Caswell County, Davidson County, Guilford County, Rockingham County 0.083 NC Cumberland County (Fayetteville, NC) Cumberland County 0.082 SC Appalachian—A (Greenville-Spartanburg-Anderson, SC) Spartanburg County, Greenville County, Anderson County 0.083 SC Central Midlands—I Columbia area Richland County (part), Lexington County
(part)0.082 TN/GA Chattanooga (Chattanooga, TN-GA) Hamilton County, TN, Meigs County, TN, Catoosa County, GA 0.084 TN Nashville (Nashville, TN) Davidson County, Rutherford County, Williamson County, Wilson County, Sumner County 0.084 TN Johnson City-Kingsport-Bristol area (TN portion only) Sullivan County, TN, Hawkins County, TN 0.083 EPA Region 6 TX San Antonio Bexar County, Comal County, Guadalupe County 0.082 V. Statutory and Executive Order Reviews A. Executive Order 12866: Regulatory Planning and Review This action is not a “significant regulatory action” under the terms of Executive Order (E.O.) 12866 (58 FR 51735; October 4, 1993) and is therefore not subject to review under the E.O. B. Paperwork Reduction Act This action does not impose an information collection burden under the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501, *et seq.* This proposed rule does not require the collection of any information. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information. An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid Office of Management and Budget
(OMB)control number. The OMB control numbers for EPA's regulations in 40 CFR are listed in 40 CFR part 9. C. Regulatory Flexibility Act The Regulatory Flexibility Act
(RFA)generally requires an Agency to prepare a regulatory flexibility analysis of any rule subject to notice and comment rulemaking requirements under the Administrative Procedures Act or any other statute unless the Agency certifies the rule will not have a significant economic impact on a substantial number of small entities. Small entities include small businesses, small organizations, and small governmental jurisdictions. For purposes of assessing the impacts of this proposed rule on small entities, small entity is defined as:
(1)A small business that is a small industrial entity as defined in the Small Business Administration's
(SBA)regulations at 13 CFR 121.201;
(2)a small governmental jurisdiction that is a government of a city, county, town, school district or special district with a population of less than 50,000; and
(3)a small organization that is any not-for-profit enterprise which is independently owned and operated and is not dominant in its field. After considering the economic impacts of this proposed rule on small entities, I certify that this rule will not have a significant economic impact on a substantial number of small entities. This proposed rule will not impose any requirements on small entities. D. Unfunded Mandates Reform Act Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public Law 104-4, establishes requirements for Federal agencies to assess the effects of their regulatory actions on State, local, and Tribal governments and the private sector. Under section 202 of the UMRA, EPA generally must prepare a written statement, including a cost-benefit analysis, for proposed and final rules with “Federal mandates” that may result in expenditures to State, local, and Tribal governments, in the aggregate, or to the private sector, of $100 million or more in any 1 year. Before promulgating an EPA rule for which a written statement is needed, section 205 of the UMRA generally requires EPA to identify and consider a reasonable number of regulatory alternatives and adopt the least costly, most cost-effective or least burdensome alternative that achieves the objectives of the rule. The provisions of section 205 do not apply when they are inconsistent with applicable law. Moreover, section 205 allows EPA to adopt an alternative other than the least costly, most cost-effective or least burdensome alternative if the Administrator publishes with the final rule an explanation why that alternative was not adopted. Before EPA establishes any regulatory requirements that may significantly or uniquely affect small governments, including Tribal governments, it must have developed under section 203 of the UMRA a small government agency plan. The plan must provide for notifying potentially affected small governments, enabling officials of affected small governments to have meaningful and timely input in the development of EPA regulatory proposals with significant Federal intergovernmental mandates, and informing, educating, and advising small governments on compliance with the regulatory requirements. This proposed rule does not contain a Federal mandate that may result in expenditures of $100 million or more for State, local, and Tribal governments, in the aggregate, or the private sector in any one year. Thus, this proposed rulemaking is not subject to the requirements of sections 202 and 205 of the UMRA. EPA has determined that this rule contains no regulatory requirements that might significantly or uniquely affect small governments because this rule does not contain Federal mandates. E. Executive Order 13132: Federalism Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999), requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the E.O. to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” This proposed rule does not have federalism implications. It will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132. The CAA establishes the scheme whereby States take the lead in developing plans to meet the NAAQS. This proposed rule would not modify the relationship of the States and EPA for purposes of developing programs to implement the NAAQS. Thus, E.O. 13132 does not apply to this proposed rule. In the spirit of Executive Order 13132, and consistent with EPA policy to promote communications between EPA and State and confined governments, EPA specifically solicits comment on this proposed rule from State and local officials. F. Executive Order 13175: Consultation and Coordination With Indian Tribal Governments Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000), requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” This proposed rule does not have “Tribal implications” as specified in E.O. 13175. It does not have a substantial direct effect on one or more Indian Tribes, since no Tribe has implemented a CAA program to attain the 8-hour ozone NAAQS at this time or has participated in a compact. Thus Executive Order 13175 does not apply to this rule. EPA specifically solicits additional comments on this proposed rule from tribal officials. G. Executive Order 13045: Protection of Children From Environmental Health and Safety Risks Executive Order 13045: “Protection of Children From Environmental Health and Safety Risks” (62 FR 19885, April 23, 1997) applies to any rule that
(1)is determined to be “economically significant” as defined under E.O. 12866, and
(2)concerns an environmental health or safety risk that EPA has reason to believe may have disproportionate effect on children. If the regulatory action meets both criteria, the Agency must evaluate the environmental health or safety effects of the planned rule on children, and explain why the planned regulation is preferable to other potentially effective and reasonably feasible alternatives considered by the Agency. This proposed rule is not subject to the Executive Order because it is not economically significant as defined in Executive Order 12866, and because the Agency does not have reason to believe the environmental health or safety risks addressed by this action present a disproportionate risk to children. The EAC program has provided cleaner air sooner than required under the CAA to these communities. The public is invited to submit or identify peer-reviewed studies and data, of which the agency may not be aware, that assessed results of early life exposure to ozone. H. Executive Order 13211: Actions That Significantly Affect Energy Supply, Distribution, or Use This proposed rule is not subject to E.O. 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355; May 22, 2001) because it is not a significant regulatory action under E.O. 12866. I. National Technology Transfer Advancement Act Section 12(d) of the National Technology Transfer Advancement Act of 1995 (NTTAA), Public Law No. 104-113, section 12(d) (15 U.S.C. 272 note) directs EPA to use voluntary consensus standards
(VCS)in its regulatory activities unless to do so would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (e.g., materials specifications, test methods, sampling procedures, and business practices) that are developed or adopted by VCS bodies. The NTTAA directs EPA to provide Congress, through OMB, explanations when the Agency decides not to use available and applicable VCS. This proposed rule does not involve technical standards. Therefore, EPA is not considering the use of any VCS. EPA welcomes comments on this aspect of the proposed rulemaking and specifically, invites the public to identify potentially-applicable voluntary consensus standards and to explain why such standards should be used in this regulation. J. Executive Order 12898: Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations Executive Order 12898 (59 FR 7629; Feb. 16, 1994) establishes Federal executive policy on environmental justice. Its main provision directs Federal agencies, to the greatest extent practicable and permitted by law, to make environmental justice part of their mission by identifying and addressing, as appropriate, disproportionately high and adverse human health or environmental effects of their programs, policies, and activities on minority populations and low-income populations in the United States. The EPA has determined that this proposed rule will not have disproportionately high and adverse human health or environmental effects on minority or low-income populations because it does not affect the level of protection provided to human health or the environment. The health and environmental risks associated with ozone were considered in the establishment of the 8-hour, 0.08 ppm ozone NAAQS. The level is designed to be protective with an adequate margin of safety. List of Subjects in 40 CFR Part 81 Environmental protection, Air pollution control. Authority: 42 U.S.C. 7408; 42 U.S.C. 7410; 42 U.S.C. 7501-7511f; 42 U.S.C. 7601(a)(1). Dated: January 31, 2008. Stephen L. Johnson, Administrator. [FR Doc. E8-2187 Filed 2-5-08; 8:45 am] BILLING CODE 6560-50-P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2007-0674; FRL-8345-2] 2,4-D, Bensulide, DCPA, Desmedipham, Dimethoate, Fenamiphos, Phorate, Sethoxydim, Terbufos, and Tetrachlorvinphos; Proposed Tolerance Actions AGENCY: Environmental Protection Agency (EPA). ACTION: Proposed rule. SUMMARY: EPA is proposing to revoke certain tolerances for the herbicide sethoxydim and the insecticides dimethoate, fenamiphos, terbufos, and tetrachlorvinphos. Also, EPA is proposing to modify certain tolerances for the herbicides 2,4-D, DCPA, desmedipham, and sethoxydim and the insecticides dimethoate, fenamiphos, phorate, and tetrachlorvinphos. In addition, EPA is proposing to establish new tolerances for the herbicides bensulide and sethoxydim. The regulatory actions proposed in this document are in follow-up to the Agency's reregistration program under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and tolerance reassessment program under the Federal Food, Drug, and Cosmetic Act (FFDCA) section 408(q). DATES: Comments must be received on or before April 7, 2008. ADDRESSES: Submit your comments, identified by docket identification
(ID)number EPA-HQ-OPP-2007-0674 by one of the following methods: • *Federal eRulemaking Portal* : *http://www.regulations.gov* . Follow the on-line instructions for submitting comments. • *Mail* : Office of Pesticide Programs
(OPP)Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. • *Delivery* : OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only accepted during the Docket's normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket Facility telephone number is
(703)305-5805. *Instructions* : Direct your comments to docket ID number EPA-HQ-OPP-2007-0674. EPA's policy is that all comments received will be included in the docket without change and may be made available on-line at *http://www.regulations.gov* , including any personal information provided, unless the comment includes information claimed to be Confidential Business Information
(CBI)or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through regulations.gov or e-mail. The regulations.gov website is an “anonymous access” system, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an e-mail comment directly to EPA without going through regulations.gov, your e-mail address will be automatically captured and included as part of the comment that is placed in the docket and made available on the Internet. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD-ROM you submit. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses. *Docket* : All documents in the docket are listed in the docket index available in regulations.gov. To access the electronic docket, go to *http://www.regulations.gov* , select “Advanced Search,” then “Docket Search.” Insert the docket ID number where indicated and select the “Submit” button. Follow the instructions on the regulations.gov website to view the docket index or access available documents. Although listed in the index, some information is not publicly available, e.g., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available either in the electronic docket at *http://www.regulations.gov* , or, if only available in hard copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The hours of operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket Facility telephone number is
(703)305-5805. FOR FURTHER INFORMATION CONTACT: Jane Smith, Special Review and Reregistration Division (7508P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:
(703)308-0048; e-mail address: *smith.jane-scott@epa.gov* . SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to: • Crop production (NAICS code 111). • Animal production (NAICS code 112). • Food manufacturing (NAICS code 311). • Pesticide manufacturing (NAICS code 32532). This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. To determine whether you or your business may be affected by this action, you should carefully examine the applicability provisions in Unit II.A. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT . B. What Should I Consider as I Prepare My Comments for EPA? 1. *Submitting CBI* . Do not submit this information to EPA through regulations.gov or e-mail. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as CBI and then identify electronically within the disk or CD-ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. 2. *Tips for preparing your comments* . When submitting comments, remember to: i. Identify the document by docket ID number and other identifying information (subject heading, **Federal Register** date and page number). ii. Follow directions. The Agency may ask you to respond to specific questions or organize comments by referencing a Code of Federal Regulations
(CFR)part or section number. iii. Explain why you agree or disagree; suggest alternatives and substitute language for your requested changes. iv. Describe any assumptions and provide any technical information and/or data that you used. v. If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced. vi. Provide specific examples to illustrate your concerns and suggest alternatives. vii. Explain your views as clearly as possible, avoiding the use of profanity or personal threats. viii. Make sure to submit your comments by the comment period deadline identified. C. What Can I do if I Wish the Agency to Maintain a Tolerance that the Agency Proposes to Revoke? This proposed rule provides a comment period of 60 days for any person to state an interest in retaining a tolerance proposed for revocation. If EPA receives a comment within the 60-day period to that effect, EPA will not proceed to revoke the tolerance immediately. However, EPA will take steps to ensure the submission of any needed supporting data and will issue an order in the **Federal Register** under FFDCA section 408(f), if needed. The order would specify data needed and the timeframes for its submission, and would require that within 90 days some person or persons notify EPA that they will submit the data. If the data are not submitted as required in the order, EPA will take appropriate action under FFDCA. EPA issues a final rule after considering comments that are submitted in response to this proposed rule. In addition to submitting comments in response to this proposal, you may also submit an objection at the time of the final rule. If you fail to file an objection to the final rule within the time period specified, you will have waived the right to raise any issues resolved in the final rule. After the specified time, issues resolved in the final rule cannot be raised again in any subsequent proceedings. II. Background A. What Action is the Agency Taking? EPA is proposing to revoke, modify, and establish specific tolerances for residues of the herbicides 2,4-D, bensulide, DCPA, desmedipham, and sethoxydim and the insecticides fenamiphos, phorate, dimethoate, terbufos, and tetrachlorvinphos in or on commodities listed in the regulatory text. EPA is proposing these tolerance actions to implement the tolerance recommendations made during the reregistration and tolerance reassessment processes (including follow-up on canceled or additional uses of pesticides). As part of these processes, EPA is required to determine whether each of the amended tolerances meets the safety standard of FFDCA. The safety finding determination of “reasonable certainty of no harm” is discussed in detail in each Reregistration Eligibility Decision
(RED)and Report of the Food Quality Protection Act
(FQPA)Tolerance Reassessment Progress and Risk Management Decision
(TRED)for the active ingredient. REDs and TREDs recommend the implementation of certain tolerance actions, including modifications to reflect current use patterns, meet safety findings, and change commodity names and groupings in accordance with new EPA policy. Printed copies of many REDs and TREDs may be obtained from EPA's National Service Center for Environmental Publications (EPA/NSCEP), P.O. Box 42419, Cincinnati, OH 45242-2419; telephone number: 1-800-490-9198; fax number: 1-513-489-8695; Internet at *http://www.epa.gov/ncepihom* and from the National Technical Information Service (NTIS), 5285 Port Royal Rd., Springfield, VA 22161; telephone number: 1-800-553-6847 or
(703)605-6000; Internet at *http://www.ntis.gov* . Electronic copies of REDs, TREDs, and IREDs are available on the Internet at *http://www. epa.gov/pesticides/reregistration/status.htm* . The selection of an individual tolerance level is based on crop field residue studies designed to produce the maximum residues under the existing or proposed product label. Generally, the level selected for a tolerance is a value slightly above the maximum residue found in such studies, provided that the tolerance is safe. The evaluation of whether a tolerance is safe is a separate inquiry. EPA recommends the raising of a tolerance when data show that: 1. Lawful use (sometimes through a label change) may result in a higher residue level on the commodity. 2. The tolerance remains safe, notwithstanding increased residue level allowed under the tolerance. In REDs, Chapter IV on “Risk management, Reregistration, and Tolerance Reassessment” typically describes the regulatory position, FQPA assessment, cumulative safety determination, determination of safety for U.S. general population, and safety for infants and children. In particular, the human health risk assessment document which supports the RED describes risk exposure estimates and whether the Agency has concerns. In TREDs, the Agency discusses its evaluation of the dietary risk associated with the active ingredient and whether it can determine that there is a reasonable certainty (with appropriate mitigation) that no harm to any population subgroup will result from aggregate exposure. EPA also seeks to harmonize tolerances with international standards set by the Codex Alimentarius Commission, as described in Unit III. Explanations for proposed modifications in tolerances can be found in the RED and TRED document and in more detail in the Residue Chemistry Chapter document which supports the RED and TRED. Copies of the Residue Chemistry Chapter documents are found in the Administrative Record electronically. Electronic copies are available through EPA's electronic public docket and comment system, regulations.gov at *http://www.regulations.gov* . You may search for docket ID number EPA-HQ-OPP-2007-0674 and/or 2,4-D (EPA-HQ-OPP-2004-0167), Bensulide (EPA-HQ-OPP-2007-0674 and EPA-HQ-OPP-2007-0151), DCPA (EPA-HQ-OPP-2007-0097), Desmedipham (EPA-HQ-OPP-2004-0261), Dimethoate (EPA-HQ-OPP-2005-0084), Fenamiphos (EPA-HQ-OPP-2007-0674 and EPA-HQ-OPP-2007-0151), Phorate (EPA-HQ-OPP-2007-0674 and EPA-HQ-OPP-2007-0151), Sethoxydim (EPA-HQ-OPP-2005-0323), Terbufos (EPA-HQ-OPP-2007-0674 and EPA-HQ-OPP-2007-0151), and Tetrachlorvinphos (EPA-HQ-OPP-2007-0674 and EPA-HQ-OPP-2007-0151) then click on that docket ID number to view its contents. EPA has determined that the aggregate exposures and risks are not of concern for the above-mentioned pesticide active ingredients based upon the data identified in the RED or TRED which lists the submitted studies that the Agency found acceptable. EPA has found that the tolerances that are proposed in this document to be modified, are safe; i.e., that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residues, in accordance with FFDCA section 408(b)(2)(C). (Note that changes to tolerance nomenclature do not constitute modifications of tolerances). These findings are discussed in detail in each RED or TRED. The references are available for inspection as described in this document under SUPPLEMENTARY INFORMATION . In addition, EPA is proposing to revoke certain specific tolerances because either they are no longer needed or are associated with food uses that are no longer registered under FIFRA. Those instances where registrations were canceled were because the registrant failed to pay the required maintenance fee and/or the registrant voluntarily requested cancellation of one or more registered uses of the pesticide. It is EPA's general practice to propose revocation of those tolerances for residues of pesticide active ingredients on crop uses for which there are no active registrations under FIFRA, unless any person in comments on the proposal indicates a need for the tolerance to cover residues in or on imported commodities or legally treated domestic commodities. 1. *2,4-D* . In the **Federal Register** notices published on June 6, 2007 (72 FR 31221) (FRL-8122-7) and September 12, 2007 (72 FR 52013) (FRL-8142-2), the Agency determined in error that the tolerances in/on grapes, stone fruits, and pome fruits should be decreased to 0.1 ppm rather than 0.05 ppm. In that same proposal, the tolerance for strawberries was increased to 0.1 ppm in error, when, in fact, it should have remained unchanged at 0.05 ppm. Therefore, EPA proposes correcting the tolerances in 40 CFR 180.142(a) for the combined 2,4-D residues of concern in/on grape from 0.1 to 0.05 ppm; fruit, stone, group 12 from 0.1 to 0.05 ppm; fruit, pome group 11 from 0.1 to 0.05 ppm, and strawberry from 0.1 to 0.05 ppm. 2. *Bensulide* . In order to account for the instability of bensulide in/on cucurbits and leafy vegetables as evidenced in a non-concurrent storage stability study, the Agency has determined the tolerances should be increased from 0.1 to 0.15 ppm in/on vegetable, cucurbit group 9 and vegetable, leafy, except brassica group 4. The Agency is also revising commodity terminology to conform to current practice including removing the negligible residue designation
(N)associated with the tolerances. Therefore, EPA proposes increasing and revising the tolerances in 40 CFR 180.241(a) for the combined bensulide residues of concern in/on cucurbits at 0.10
(N)ppm to vegetable, cucurbit group 9 at 0.15; and vegetable, leafy at 0.1
(N)ppm to vegetable, leafy, except brassica group 4 at 0.15 ppm. The Agency determined that the increased tolerances are safe; i.e. there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue. Because the use of bensulide is limited to Texas, the Agency has determined that the carrot tolerance should be a regional tolerance. Therefore, EPA proposes transferring the carrot, root at 0.1 ppm tolerance in 40 CFR 180.241(a) to 40 CFR 180.241(c). Based on available field trial data that indicate bensulide residues of concern are less than 0.15 ppm in/on the representative commodities (broccoli, cabbage, and Brussels sprouts) of the vegetable, brassica, leafy group 5, the Agency determined that the tolerance should be established for vegetable, brassica, leafy group 5 at 0.15 ppm. Therefore, EPA proposes establishing a tolerance in 40 CFR 180.241(a) for combined bensulide residues of concern in/on vegetable, brassica, leafy group 5 at 0.15 ppm. The Agency is revising commodity terminology to conform to current practice. Therefore, EPA proposes revising the tolerances in 40 CFR 180.241 from onion, dry bulb to onion, bulb; and vegetable, fruiting to vegetable, fruiting, group 8. Currently, there are no Codex MRLs (maximum residue levels) in place for bensulide. 3. *DCPA* . In the **Federal Register** proposal and final rule published on June 6, 2007 (72 FR 31221) (FRL-8122-7), and September 12, 2007 (72 FR 52013) (FRL-8142-2), the permanent tolerance on vegetable, brassica, leafy, group 5 at 5 ppm was transferred to inadvertent tolerance because there were no uses on brassica vegetables. Since then, it has been determined that there are direct uses of DCPA on brassica vegetables and a permanent tolerance in/on vegetable, brassica, leafy, group 5 at 5 ppm is appropriate. Therefore, EPA proposes transferring the tolerance vegetable, brassica, leafy, group 5 at 5 ppm in 40 CFR 180.185(d) to 40 CFR 180.185(a) for the combined residues of the herbicide DCPA and its metabolites MTP and TCP (calculated as DCPA). 4. *Desmedipham* . Based on field trial data received subsequent to the TRED that indicate residues of desmedipham as high as 0.05 ppm in/on sugar beet roots and an average of 1.38 ppm (standard deviation 2.88 ppm) in/on sugar beet tops, the Agency determined that the tolerance should be decreased from 0.2 ppm to 0.1 ppm in/on sugar beet roots and increased from 0.2 ppm to 5.0 ppm in/on sugar beet tops. Therefore, EPA proposes revising the tolerance on sugar beet (roots and tops) from 0.2 ppm to sugar, beet, roots at 0.1 ppm and sugar, beet, tops at 5.0 ppm in 40 CFR 180.353(a) for residues of the herbicide desmedipham (ethyl-m-hydroxycarbanilate carbanilate). The Agency determined that the increased tolerances are safe; i.e. there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue. Currently, there are no Codex MRLs in place for desmedipham. 5. *Dimethoate* . The uses on apples, cabbage, collards, head lettuce, spinach, and grapes were canceled due to revisions of the human health risk assessment for tolerance reassessment as published in **Federal Register** Notices dated Sept 10, 2003 (69 FR 53371) (FRL-7321-2), January 28, 2004 (69 FR 4135) (FRL-7340-1), and May 12, 2004 (69 FR 26384) (FRL-7354-3). Although the use on head lettuce has been canceled, the use on leaf lettuce remains. There are no active registrations with the use on blueberries; however, the blueberry tolerance is for the purpose of imports and for this reason will not be revoked. Lentils are covered by the existing pea, dry tolerance in accordance with 40 CFR 180.1(g). Therefore, EPA proposes revoking the tolerances in 40 CFR 180.204(a) for the combined dimethoate residues of concern in/on apple at 2 ppm; cabbage at 2 ppm; collards at 2 ppm; grape at 1 ppm; lentil, seed at 2 ppm; and spinach at 2 ppm; and revise lettuce to lettuce, leaf. Based on field trial residue data serving as the basis of the tolerance on potatoes at 0.2 ppm and translating those data to turnip roots, the Agency has determined that the tolerance in/on turnip roots should be decreased to 0.2 ppm. Therefore, EPA proposes decreasing the tolerance in 40 CFR 180.204(a) for the combined dimethoate residues of concern in/on turnip, roots from 2 ppm to 0.2 ppm. Based on available field trial data that indicate dimethoate residues of concern less than 0.1 ppm in/on sorghum grain and forage, the Agency determined that the tolerance should be decreased to 0.1 ppm in/on sorghum, grain, forage and a tolerance should be established for sorghum, grain, stover at 0.1 ppm. EPA is also revising the commodity terminology to conform to current Agency practice. Therefore, EPA proposes decreasing and revising the tolerance in 40 CFR 180.204(a) for the combined dimethoate residues of concern from sorghum, forage at 0.2 ppm to sorghum, grain, forage at 0.1 ppm and establishing a tolerance on sorghum, grain, stover at 0.1 ppm. EPA is revising the commodity terminology to conform to current Agency practice. Also, when the tolerance reassessment was conducted for reregistration on dimethoate, the tolerance on “wheat, green fodder” existed. The correct terminology for “wheat, green fodder” is “wheat, hay” and “wheat, forage.” Recently, 40 CFR 180.204 has been revised to align commodity terminology to current standards. At that time, the “wheat, green fodder” tolerance was revised to “wheat, hay” and the tolerance for “wheat, forage” was inadvertently omitted; therefore, the wheat, forage tolerance should be established. Lastly, the Agency is correcting the reference to 180.1(n) to 180.1(m) in 40 CFR 180.204(c). Therefore, EPA proposes revising the tolerances in 40 CFR 180.204(a) for the combined dimethoate residues of concern in/on alfalfa to alfalfa, forage and alfalfa, hay; from corn, forage to corn, field, forage and corn, sweet, forage; corn, grain to corn, field, grain and corn, pop, grain; corn, stover to corn, field, stover and corn, pop, stover; sorghum, grain to sorghum, grain, grain; soybean to soybean, seed; and turnip, greens to turnip, tops; proposes establishing a tolerance in/on wheat, forage at 2.0 ppm and proposes revising tolerances in 40 CFR 180.204(c) from cherry to cherry, sweet and cherry, tart and revising the reference of 180.1(n) to 180.1(m). The Codex Alimentarius Commission has established separate maximum residue limits
(MRLs)for dimethoate per se and omethoate per se in/on various commodities resulting from application of the insecticides dimethoate, formothion, and omethoate. By contrast, the U.S. tolerance expression is in terms of the combined residues of dimethoate and omethoate, as a metabolite. Formothion and omethoate are not currently registered for use in the U.S. Therefore, the Codex MRLs and U.S. tolerances are not harmonized with respect to MRL/tolerance expression. 6. *Fenamiphos* . Based on the available field trial data that indicate fenamiphos residues of concern are up to 1.0 ppm in/on peanuts, the Agency determined that the tolerance should be increased to 1.0 ppm. Therefore, EPA proposes increasing the tolerance in 40 CFR 180.349(a)(1) for fenamiphos residues of concern in/on peanut from 0.02 ppm to 1.0 ppm. The Agency determined that the increased tolerance is safe; i.e., there is a reasonable certainty that no harm will result form aggregate exposure to the pesticide chemical residue. Based on the available field trial data that indicate fenamiphos residues of concern are less than 0.05 ppm in/on eggplant and Brussels sprouts, the Agency determined that the tolerances should be decreased to 0.05 ppm. The Agency is also decreasing the Brussels sprouts tolerance to harmonize with Codex. Therefore, EPA proposes decreasing the tolerance in 40 CFR 180.349(a)(1) for fenamiphos residues of concern in/on eggplant from 0.10 ppm to 0.05 ppm and Brussels sprouts from 0.10 ppm to 0.05 ppm. Pineapple bran is no longer regulated as a commodity in accordance with Table 1.—Raw Agricultural and Processed Commodities and Feedstuffs Derived from Crops which is found in Residue Chemistry Test Guidelines OPPTS 860.1000 dated August 1996, available at *http://www.epa.gov/opptsfrs/publications/OPPTS Harmonized/860 Residue Chemistry Test Guidelines/Series* ; consequently, the Agency has determined that a pineapple bran tolerance is no longer needed. There are no active registrations for the use of fenamiphos on cotton, consequently the Agency has determined the cotton undelinted seed tolerance should be revoked. Therefore, EPA proposes removing the tolerance in/on pineapple, bran and revoking the tolerance in/on cotton, undelinted seed in 40 CFR 180.349(a)(1) for fenamiphos residues of concern. There are currently individual tolerances for grapefruit, lemon, lime, orange, and tangerine each at 0.60 ppm. Because there are established tolerances for the representative commodities for the fruit, citrus, group 10 and the use patterns on these commodities are the same, the Agency determined that the individual tolerances should be replaced with the fruit, citrus, group 10 tolerance. Further, in order to harmonize with the Codex MRLs, the Agency has determined the tolerances associated with these commodities should be decreased from 0.60 to 0.50 ppm. Therefore, EPA proposes removing the tolerances in 40 CFR 180.349(a)(1) for fenamiphos residues of concern in/on grapefruit; lemon; lime; orange, sweet; and tangerine each at 0.60 ppm and establishing a tolerance for fruit, citrus, group 10 at 0.50 ppm. Based on revisions of the OPPTS Harmonized Test Guidelines--Series 860 Residue Chemistry Guidelines (August 1996) Table 1 available at *http://www.epa.gov/opptsfrs/publications/OPPTS Harmonized/860 Residue Chemistry Test Guidelines/Series* eliminating several animal feed items used to estimate secondary residues in livestock commodities, the Agency determined there is no expectation of finite residues in animal commodities in accordance with Category 40 CFR 180.6(a)(3). Therefore, EPA proposes revoking all of the tolerances in 40 CFR 180.349(a)(2) for fenamiphos residues of concern in cattle, fat; cattle, meat; cattle, meat byproducts; goat, fat; goat, meat; goat, meat byproducts; hog, fat; hog, meat; hog, meat byproducts; horse, fat; horse, meat; horse, meat byproducts; milk; sheep, fat; sheep, meat; sheep, meat byproducts each at 0.05 ppm; remove 40 CFR 180.349(a)(2); and designate 40 CFR 180.349(a)(1) as 40 CFR 180.349(a). The Agency is revising commodity terminology to correspond to current Agency practice. Therefore, EPA proposes revising tolerances in 40 CFR 180.349(a)(1) for fenamiphos residues of concern in/on grape, raisins to grape, raisin and cherry to cherry, sweet and cherry, tart. In accordance with section 6(f)(1) of FIFRA, the Agency issued a cancellation order published on December 10, 2003 (68 FR 68901) (FRL-7332-5). The order reflects the voluntary cancellations submitted by Bayer CropScience for product registrations containing fenamiphos effective May 31, 2007. The order requires the registrant to cease sale/distribution of products (by persons other that Bayer CropScience) containing fenamiphos by May 31, 2008. Bayer CropScience anticipates that commodities treated with fenamiphos may continue to be imported into the U.S. after the final effective dates and therefore supports import tolerances for banana; fruit, citrus, group 10; garlic; grape; and pineapple. In order to permit the use of existing stocks of products to clear the channels of trade and for tolerances to cover subsequent fenamiphos residues of concern on commodities, the Agency determined the tolerances should expire on December 31, 2009 except for those tolerances for import commodities (banana; fruit, citrus, group 10; citrus, dried pulp; citrus, oil; garlic; grape; and pineapple). The tolerances for banana; fruit, citrus, group 10; garlic; grape; and pineapple will not have a U.S. registration as of December 31, 2009, and will be designated as such by a footnote. Therefore, EPA proposes establishing an expiration/revocation date of December 31, 2009, on tolerances in 40 CFR 180.349 for fenamiphos residues of concern in/on apple; Brussels sprouts; cabbage; cherry, sweet; cherry, tart; eggplant; okra; peach; peanut; raspberry; strawberry; asparagus; beet, garden, roots; beet, garden, tops; Bok choy; kiwifruit; and pepper, nonbell and add the footnote “1 There are no U.S. registrations as of December 31, 2009.” 7. *Phorate* . Based on available field trial data that indicate phorate residues of concern do not exceed 0.05 ppm in or on beans, field and sweet corn; sorghum, grain; soybean; and sugarcane, cane; the Agency determined that the tolerance should be decreased to 0.05 ppm in/on field and sweet corn, sorghum, grain; soybean; and sugarcane, cane. Based on available field trial data that indicate phorate residues of concern do not exceed 0.2 ppm in/on potato and in order to harmonize with CODEX, the Agency has determined the tolerance should be decreased to 0.2 ppm. Therefore, EPA proposes decreasing the tolerances in 40 CFR 180.206(a) for phorate residues of concern in/on bean; corn, sweet, kernel plus cob with husks removed; corn, grain; sorghum, grain; soybean; and sugarcane, cane from 0.1 to 0.05 ppm; and potato from 0.5 to 0.2 ppm. Based on available field trial data that indicate phorate residues of concern are up to 2.0 ppm in or on hops, the Agency determined that the tolerance should be increased to 2.0 ppm. Therefore, EPA is proposing to increase the tolerances in 40 CFR 180.206(a) for phorate residues of concern in/on hop from 0.5 to 2.0 ppm. The Agency determined that the increased tolerances are safe; i.e. there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue. The current tolerances in 40 CFR 180.206 are expressed in terms of phorate and its cholinesterase-inhibiting metabolites. The Agency has determined that the tolerance expression should be revised to harmonize with CODEX by regulating phorate, phorate sulfoxide, phorate sulfone, phorate oxygen analog, phorate oxygen analog sulfoxide, and the phorate oxygen analog sulfone, specifically. Therefore, EPA proposes revising the tolerance expression in 40 CFR 180.206(a) to regulate the combined residues of the insecticide phorate (O,O-diethyl S[(ethylthio) methyl]phosphorodithioate), phorate sulfoxide, phorate sulfone, phorate oxygen analog, phorate oxygen analog sulfoxide, and phorate oxygen analog sulfone. When the tolerance reassessment was conducted for reregistration on phorate, the tolerance on “wheat, green fodder” existed. The correct terminology for “wheat, green fodder” is “wheat, hay” and “wheat, forage.” Recently, 40 CFR part 180 has been revised to align commodity terminology to current standards. At that time, the “wheat, green fodder” tolerance was revised to “wheat, hay” and the tolerance for “wheat, forage” was inadvertently omitted. Therefore, the Agency has determined a tolerance in/on wheat, forage at 1.5 ppm should be established. Therefore, EPA proposes establishing a tolerance in 40 CFR 180.206(a) for the combined residues of phorate and its cholinesterase-inhibiting metabolites in/on wheat, forage at 1.5 ppm. The Agency determined that the increased tolerances are safe; i.e. there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue. EPA is revising commodity terminology to conform to current Agency practice. Therefore, EPA proposes revising the tolerances in 40 CFR 180.206(a) for the combined residues of phorate and its cholinesterase-inhibiting metabolites from bean to bean, dry, seed and bean, succulent; coffee, bean, green to coffee, green bean; corn, forage to corn, field, forage and corn, sweet, forage; corn, grain to corn, field, grain; hop to hop, dried cones; sorghum, grain to sorghum, grain, grain; and soybean to soybean, seed; and revise the footnote to “There are no U.S. registrations as of September 1, 1993, for the use of phorate on the growing crop, coffee.” The proposed tolerance actions herein for phorate, to implement the recommendations of the phorate IRED, reflect use patterns in the U.S. which support a different tolerance than the Codex level on beans, beets, coffee beans, because of differences in good agricultural practices. However, compatibility currently exists between U.S. tolerances and Codex MRLs for cottonseed and will exist (upon completion of this action) for phorate residues in or on potato, sorghum grain, soybean seed, field and sweet corn/maize. 8. *Sethoxydim* . Based on available field trial data that indicate residues of sethoxydim as high as 50.7 ppm in or on clover hay and 2.2 ppm in/on cranberry, the Agency determined that the tolerance should be increased to 55 ppm in/on clover, hay and 2.5 ppm in/on cranberry. Therefore, EPA is proposing to increase the tolerances in 40 CFR 180.412 for sethoxydim residues of concern in/on clover, hay from 50 to 55 ppm and cranberry from 2.0 to 2.5 ppm. The Agency determined that the increased tolerances are safe; i.e. there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue. EPA is revising commodity terminology to conform to current Agency practice. Therefore, EPA proposes revising the tolerances in 40 CFR 180.412(a) for sethoxydim residues of concern in/on bean, forage to cowpea, forage; bean, hay to cowpea, hay; canola/rapeseed to rapeseed, seed and canola, seed; canola/rapeseed, meal to rapeseed, meal and canola, meal; coriander to coriander, leaves; corn, fodder to corn, field, fodder; corn, forage to corn, field, stover; fruit, citrus to fruit, citrus, group 10; fruit, pome to fruit, pome, group 11; peppermint, tops (stems and leaves) to peppermint, tops; potato flakes and potato granules to potato granules/flakes; potato waste, processed (wet and dry) to potato waste, processed; safflower to safflower, seed; soybean to soybean, seed; spearmint, tops (stems and leaves) to spearmint, tops; turnip, greens to turnip, tops; and vegetable, fruiting to vegetable, fruiting, group 8. As part of improving sethoxydim tolerance harmonization between the U.S. and Canada, the Agency has reexamined the residue data and tolerance levels for bean, dry, seed at 20 ppm; lentil, seed at 30 ppm; and pea, dry, seed 40 ppm. Using the tolerance/MRL calculator developed under the North American Free Trade Agreement (NAFTA) and the dry peas, lentil, and dry bean field trial data which reflect similar use patterns, the Agency has determined the tolerances on the dry pea, lentil seed, and dry bean commodities can be revised to the pea and bean, dried shelled, except soybean, subgroup 6C at 25 ppm, which covers these commodities. Therefore, EPA proposes revising the tolerances in 40 CFR 180.412(a) for sethoxydim residues of concern from bean, dry seed at 20 ppm; lentil, seed at 30 ppm; and pea, dry, seed at 40 ppm to pea and bean, dried shelled, except soybean, subgroup 6C at 25 ppm. Because apple dry pomace, citrus molasses, cotton seed soapstock, flax straw, peanut soapstock, tomato concentrated products, and tomato dry pomace are no longer recognized as raw agricultural commodities and are no longer considered to be significant food/feed items, the associated tolerances are no longer needed. The tolerance for flax seed currently covers the commodity flax, meal, therefore the flax, meal tolerance is no longer needed. Therefore, EPA is removing the tolerances in 40 CFR 180.412(a) in/on apple, dry pomace at 0.8 ppm; citrus, molasses at 1.5 ppm; cotton, seed, soapstock at 15 ppm; flax, straw at 2.0 ppm; flax, meal at 7 ppm; peanut, soapstock at 75.0 ppm; tomato, concentrated products at 24 ppm; and tomato, dry pomace at 12.0 ppm. Currently, there are no Codex MRLs in place for sethoxydim. 9. *Terbufos* . The current tolerance expression in 40 CFR 180.352 regulates the insecticide terbufos (S-[[1,1-dimethyl)thio]methyl]O,O-diethyl phosphorodithioate) and its cholinesterase-inhibiting metabolites. The Agency has determined that the chemical name for terbufos should be corrected and the tolerance expression should be more specific for the five phosphorylated (cholinesterase-inhibiting) metabolites. Therefore, EPA proposes revising the tolerance expression in 40 CFR 180.352(a) to regulate the combined residues of the insecticide terbufos (phosphorodithioic acid, S-(t-butylthio)methyl O,O-diethyl ester) and its phosphorylated (cholinesterase-inhibiting) metabolites (phosphorothioic acid, S-(t-butylthio)methyl O,O-diethyl ester; phosphorothioic acid, S-(t-butylsulfinyl)methyl O,O-diethyl ester; phosphorothioic acid, S-(t-butylsulfonyl)methyl O,O-diethyl ester; phosphorodithioic acid, S-(t-butylsulfinyl)methyl O,O-diethyl ester; and phosphorodithioic acid, S-(t-butylsulfonyl)methyl O,O-diethyl ester). The Agency has determined that the coffee bean, green tolerance should be established for import purposes. The Agency is also revising the section to conform to current standards and configurations. Therefore, EPA proposes transferring the tolerance in 40 CFR 180.352(b) for the combined residues of terbufos and its cholinesterase-inhibiting metabolites in/on coffee bean, green at 0.05 ppm to 40 CFR 180.352(a); redesignate 40 CFR 180.352(b) as Section 18 emergency exemptions-reserved; establish 40 CFR 180.352(c) as tolerances with regional registrations-reserved and establish 40 CFR 180.352(d) as indirect or inadvertent residues - reserved. EPA is revising commodity terminology to conform to current Agency practice and removing “(N)”- negligible residue designation associated with some of the tolerances because the term is no longer applicable. Because tolerances on corn, pop, forage and corn, pop, stover refer to the same commodity (i.e. duplicative) and because corn, pop, stover is the most current terminology, the Agency has determined the tolerance on corn, pop, forage should be removed. Therefore, EPA proposes revising the tolerances in 40 CFR 180.352(a) for the combined residues of terbufos and its cholinesterase-inhibiting metabolites from corn, grain to corn, field, grain and corn, pop, grain; sorghum, forage to sorghum, grain, forage; and sorghum, grain to sorghum, grain, grain and removing corn, pop, forage. The proposed tolerance actions herein for terbufos, to implement the recommendations of the terbufos RED, reflect different method levels of detection
(LOD)where the LOD under the CODEX system is 0.01 ppm and the LOD under the U.S. system is 0.05 ppm which result in differing Codex levels on banana, corn/maize, popcorn, sugar beets, and sweet corn than the U.S. tolerances. Other differences in MRLs and tolerances between CODEX and the U.S. exist for cereal grain straw, fodder and stover because some are measured on a dry weight basis versus a wet weight basis. Lastly, the CODEX levels have changed since the tolerance reassessment such that, currently none of the U.S. tolerances and CODEX tolerances are harmonized. 10. *Tetrachlorvinphos* . Currently, the residue of concern in 40 CFR 180.252(a)(1) is tetrachlorvinphos (2-chloro-1-(2,4,5-trichlorophenyl)vinyl dimethyl phosphate). The chemical name of tetrachlorvinphos as specified in 40 CFR 180.252 should be replaced with the CAS chemical name: (Z)-2-chloro-1-(2,4,5-trichlorophenyl)vinyl dimethyl phosphate. The Agency has also determined that the metabolites, 1-(2,4,5-trichlorophenyl)-ethanol (free and conjugated forms), 2,4,5-trichloroacetophenone, and 1-(2,4,5-trichlorophenyl)-ethanediol are also of toxicological concern and should be regulated. Therefore, EPA proposes revising the tolerance expression in 40 CFR 180.252(a)(1) to regulate the residues of the insecticide tetrachlorvinphos ((Z)-2-chloro-1-(2,4,5-trichlorophenyl)vinyl dimethyl phosphate) and its metabolites, 1-(2,4,5-trichlorophenyl)-ethanol (free and conjugated forms), 2,4,5-trichloroacetophenone, and 1-(2,4,5-trichlorophenyl)-ethanediol. Currently, EPA has insufficient data to establish permanent tolerances for milk, cattle, hog and poultry commodities; however, EPA has been able to estimate tolerances for these livestock commodities using existing animal metabolism data on an interim basis of 18 months to permit time for the submission of additional data to support permanent tolerances. The tolerances are also being revised to address the additional tetrachlorvinphos metabolites of concern. Based on the metabolism data which indicate the tetrachlorvinphos residues of concern as high as 0.18 ppm in/on cattle and hog fat; 0.50 ppm in/on cattle and hog kidney; 0.38 ppm in/on cattle and hog liver; 1.86 ppm in/on cattle and hog meat; 0.50 ppm in/on cattle and hog meat byproducts except kidney and liver; 0.02 ppm in milk; 0.19 ppm in/on eggs; 6.1 ppm in/on poultry fat; 2.32 ppm in/on poultry meat; 1.27 ppm in/on poultry liver and 1.27 ppm in/on meat byproducts except liver, the Agency determined that interim tolerances should be established for 18 months at the decreased levels of 0.2 ppm (of which no more than 0.1 ppm is tetrachlorvinphos per se) in/on cattle and hog fat; and 0.05 ppm (of which no more than 0.05 ppm is tetrachlorvinphos per se) in/on milk, fat. The Agency also determined that interim tolerances should be established for 18 months at 1.0 ppm (of which no more than 0.05 ppm is tetrachlorvinphos per se) in/on cattle and hog kidney; 0.5 ppm (of which no more than 0.05 ppm is tetrachlorvinphos per se) in/on cattle and hog liver; 2.0 ppm (of which no more than 2.0 ppm is tetrachlorvinphos per se) cattle and hog meat; 1.0 ppm in/on cattle and hog meat byproducts except liver and kidney; 3.0 ppm (of which no more than 3.0 ppm is tetrachlorvinphos per se) in/on poultry meat; 2.0 ppm (of which no more than 0.05 ppm is tetrachlorvinphos per se) in/on poultry liver; and 2.0 ppm in/on poultry meat byproducts except liver. The Agency determined that interim tolerances should be established for 18 months at the increased level of 0.2 ppm (of which no more than 0.05 ppm is tetrachlorvinphos per se) in/on eggs; and 7.0 ppm (of which no more than 7.0 ppm is tetrachlorvinphos per se) in/on poultry fat. Therefore, EPA proposes revising and establishing 18-month time-limited tolerances in newly proposed 40 CFR 180.252(a)(1) for residues of the insecticide tetrachlorvinphos and its metabolites in/on cattle, fat and hog, fat from 1.5 ppm to 0.2 ppm (of which no more than 0.1 ppm is tetrachlorvinphos per se); cattle, kidney and hog, kidney at 1.0 ppm (of which no more than 0.05 ppm is tetrachlorvinphos per se); cattle, liver and hog, liver at 0.5 ppm (of which no more than 0.05 ppm is tetrachlorvinphos per se); cattle, meat and hog, meat at 2.0 ppm (of which no more than 2.0 ppm is tetrachlorvinphos per se); cattle, meat byproducts except kidney and liver and hog, meat byproducts except kidney and liver at 1.0 ppm; milk, fat at 0.05 ppm reflecting negligible residues in whole milk (of which no more than 0.05 ppm is tetrachlorvinphos per se); eggs from 0.1 to 0.2 ppm (of which no more than 0.05 ppm is tetrachlorvinphos per se); poultry, fat from 0.7 to 7.0 ppm (of which no more than 7.0 ppm is tetrachlorvinphos per se); poultry, meat at 3.0 ppm (of which no more than 3.0 ppm is tetrachlorvinphos per se); poultry, liver at 2.0 ppm (of which no more than 0.05 ppm is tetrachlorvinphos per se); and poultry, meat byproducts except liver at 2.0 ppm all of which expire on [18 months from the date of final publication]. The Agency determined that the increased tolerances are safe; i.e. there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue. Because the Agency is taking action to establish the time-limited tolerances in/on cattle, hog and poultry commodities (above), the Agency has determined that the exception that permits “the safe use of tetrachlorvinphos as an additive to beef cattle, dairy cattle, horse and swine feed at the rates of 0.00015 lb per 100 lb body weight per day for cattle and horses, and 0.00011 lb per 100 lb body weight per day for swine” is no longer necessary. In addition, any uses of tetrachlorvinphos in/on horses destined for slaughter are prohibited. Therefore, EPA proposes revoking the tolerances in 40 CFR 180.252(a)(1) for residues of the insecticide tetrachlorvinphos in/on goat, fat at 0.5 ppm; horse, fat at 0.5 ppm; removing 40 CFR 180.252(a)(2); and changing the designation of 40 CFR 180.252(a)(1) to 40 CFR 180.252(a). Currently, there are no Codex MRLs in place for tetrachlorvinphos. B. What is the Agency's Authority for Taking this Action? A “tolerance” represents the maximum level for residues of pesticide chemicals legally allowed in or on raw agricultural commodities and processed foods. Section 408 of FFDCA, 21 U.S.C. 346a, as amended by FQPA of 1996, Public Law 104-170, authorizes the establishment of tolerances, exemptions from tolerance requirements, modifications in tolerances, and revocation of tolerances for residues of pesticide chemicals in or on raw agricultural commodities and processed foods. Without a tolerance or exemption, food containing pesticide residues is considered to be unsafe and therefore “adulterated” under section 402(a) of FFDCA, 21 U.S.C. 342(a). Such food may not be distributed in interstate commerce (21 U.S.C. 331(a)). For a food-use pesticide to be sold and distributed, the pesticide must not only have appropriate tolerances under the FFDCA, but also must be registered under FIFRA (7 U.S.C. 136 *et seq.* ). Food-use pesticides not registered in the United States must have tolerances in order for commodities treated with those pesticides to be imported into the United States. EPA is proposing these tolerance actions to implement the tolerance recommendations made during the reregistration and tolerance reassessment processes (including follow-up on canceled or additional uses of pesticides). As part of these processes, EPA is required to determine whether each of the amended tolerances meets the safety standard of FQPA. The safety finding determination is discussed in detail in each post-FQPA RED and TRED for the active ingredient. REDs and TREDs recommend the implementation of certain tolerance actions, including modifications to reflect current use patterns, to meet safety findings, and change commodity names and groupings in accordance with new EPA policy. Printed and electronic copies of the REDs and TREDs are available as provided in Unit II.A. EPA has issued post-FQPA REDs (and Interim REDs) for 2,4-D, bensulide, DCPA, desmedipham, dimethoate, fenamiphos, phorate, sethoxydim, terbufos, and tetrachlorvinphos, whose REDs were completed prior to FQPA. Also, EPA issued a RED prior to FQPA for tetrachlorvinphos and made a safety finding which reassessed its tolerances according to the FFDCA standard, maintaining them when new tolerances were established as noted in Unit II.A. REDs and TREDs contain the Agency's evaluation of the database for these pesticides, including requirements for additional data on the active ingredients to confirm the potential human health and environmental risk assessments associated with current product uses, and in REDs state conditions under which these uses and products will be eligible for reregistration. The REDs and TREDs recommended the establishment, modification, and/or revocation of specific tolerances. RED and TRED recommendations such as establishing or modifying tolerances, and in some cases revoking tolerances, are the result of assessment under the FFDCA standard of “reasonable certainty of no harm.” However, tolerance revocations recommended in REDs and TREDs that are proposed in this document do not need such assessment when the tolerances are no longer necessary. EPA's general practice is to propose revocation of tolerances for residues of pesticide active ingredients on crops for which FIFRA registrations no longer exist and on which the pesticide may therefore no longer be used in the United States. EPA has historically been concerned that retention of tolerances that are not necessary to cover residues in or on legally treated foods may encourage misuse of pesticides within the United States. Nonetheless, EPA will establish and maintain tolerances even when corresponding domestic uses are canceled if the tolerances, which EPA refers to as “import tolerances,” are necessary to allow importation into the United States of food containing such pesticide residues. However, where there are no imported commodities that require these import tolerances, the Agency believes it is appropriate to revoke tolerances for unregistered pesticides in order to prevent potential misuse. Furthermore, as a general matter, the Agency believes that retention of import tolerances not needed to cover any imported food may result in unnecessary restriction on trade of pesticides and foods. Under section 408 of FFDCA, a tolerance may only be established or maintained if EPA determines that the tolerance is safe based on a number of factors, including an assessment of the aggregate exposure to the pesticide and an assessment of the cumulative effects of such pesticide and other substances that have a common mechanism of toxicity. In doing so, EPA must consider potential contributions to such exposure from all tolerances. If the cumulative risk is such that the tolerances in aggregate are not safe, then every one of these tolerances is potentially vulnerable to revocation. Furthermore, if unneeded tolerances are included in the aggregate and cumulative risk assessments, the estimated exposure to the pesticide would be inflated. Consequently, it may be more difficult for others to obtain needed tolerances or to register needed new uses. To avoid potential trade restrictions, the Agency is proposing to revoke tolerances for residues on crops for uses for which FIFRA registrations no longer exist, unless someone expresses a need for such tolerances. Through this proposed rule, the Agency is inviting individuals who need these import tolerances to identify themselves and the tolerances that are needed to cover imported commodities. Parties interested in retention of the tolerances should be aware that additional data may be needed to support retention. These parties should be aware that, under FFDCA section 408(f), if the Agency determines that additional information is reasonably required to support the continuation of a tolerance, EPA may require that parties interested in maintaining the tolerances provide the necessary information. If the requisite information is not submitted, EPA may issue an order revoking the tolerance at issue. When EPA establishes tolerances for pesticide residues in or on raw agricultural commodities, consideration must be given to the possible residues of those chemicals in meat, milk, poultry, and/or eggs produced by animals that are fed agricultural products (for example, grain or hay) containing pesticides residues (40 CFR 180.6). When considering this possibility, EPA can conclude that: 1. Finite residues will exist in meat, milk, poultry, and/or eggs. 2. There is a reasonable expectation that finite residues will exist. 3. There is a reasonable expectation that finite residues will not exist. If there is no reasonable expectation of finite pesticide residues in or on meat, milk, poultry, or eggs, tolerances do not need to be established for these commodities (40 CFR 180.6(b) and (c)). EPA has evaluated certain specific meat, milk, poultry, and egg tolerances proposed for revocation in this document and has concluded that there is no reasonable expectation of finite pesticide residues of concern in or on those commodities. C. When Do These Actions Become Effective? EPA is proposing that the tolerance actions herein become effective on the date of publication of the final rule in the **Federal Register** . The tolerances proposed for revocation in this document are associated with uses that have been canceled for several years and none of the other tolerance actions proposed herein are expected to result in adulterated commodities. The Agency believes that treated commodities have had sufficient time for passage through the channels of trade. However, if EPA is presented with information that existing stocks would still be available and that information is verified, the Agency will consider revising the expiration date of the tolerance in the final rule. If you have comments regarding existing stocks and whether the effective date allows sufficient time for treated commodities to clear the channels of trade, please submit comments as described under SUPPLEMENTARY INFORMATION . Any commodities listed in this proposal treated with the pesticides subject to this proposal, and in the channels of trade following the tolerance revocations, shall be subject to FFDCA section 408(1)(5), as established by FQPA. Under this unit, any residues of these pesticides in or on such food shall not render the food adulterated so long as it is shown to the satisfaction of the Food and Drug Administration that: 1. The residue is present as the result of an application or use of the pesticide at a time and in a manner that was lawful under FIFRA, and 2. The residue does not exceed the level that was authorized at the time of the application or use to be present on the food under a tolerance or exemption from a tolerance. Evidence to show that food was lawfully treated may include records that verify the dates when the pesticide was applied to such food. III. Are the Proposed Actions Consistent with International Obligations? The tolerance actions in this proposal are not discriminatory and are designed to ensure that both domestically produced and imported foods meet the food safety standards established by FFDCA. The same food safety standards apply to domestically produced and imported foods. In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international Maximum Residue Limits
(MRLs)established by the Codex Alimentarius is a joint U.N. Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level in a notice published for public comment. EPA's effort to harmonize with Codex MRLs is summarized in the tolerance reassessment section of individual REDs and TREDs, and in the Residue Chemistry document which supports the RED and TRED, as mentioned in Unit II.A. Specific tolerance actions in this proposed rule and how they compare to Codex MRLs (if any) are discussed in Unit II.A. IV. Statutory and Executive Order Reviews In this proposed rule, EPA is proposing to establish tolerances under FFDCA section 408(e), and also modify and revoke specific tolerances established under FFDCA section 408. The Office of Management and Budget
(OMB)has exempted these types of actions (e.g., establishment and modification of a tolerance and tolerance revocation for which extraordinary circumstances do not exist) from review under Executive Order 12866, entitled *Regulatory Planning and Review* (58 FR 51735, October 4, 1993). Because this proposed rule has been exempted from review under Executive Order 12866 due to its lack of significance, this proposed rule is not subject to Executive Order 13211, *Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use* (66 FR 28355, May 22, 2001). This proposed rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 *et seq* ., or impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995
(UMRA)(Public Law 104-4). Nor does it require any special considerations as required by Executive Order 12898, entitled *Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations* (59 FR 7629, February 16, 1994); or OMB review or any other Agency action under Executive Order 13045, entitled *Protection of Children from Environmental Health Risks and Safety Risks* (62 FR 19885, April 23, 1997). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Pursuant to the Regulatory Flexibility Act
(RFA)(5 U.S.C. 601 *et seq* .), the Agency previously assessed whether establishment of tolerances, exemptions from tolerances, raising of tolerance levels, expansion of exemptions, or revocations might significantly impact a substantial number of small entities and concluded that, as a general matter, these actions do not impose a significant economic impact on a substantial number of small entities. These analyses for tolerance establishments and modifications, and for tolerance revocations were published on May 4, 1981 (46 FR 24950) and on December 17, 1997 (62 FR 66020) (FRL-5753-1), respectively, and were provided to the Chief Counsel for Advocacy of the Small Business Administration. Taking into account this analysis, and available information concerning the pesticides listed in this proposed rule, the Agency hereby certifies that this proposed rule will not have a significant negative economic impact on a substantial number of small entities. In a memorandum dated May 25, 2001, EPA determined that eight conditions must all be satisfied in order for an import tolerance or tolerance exemption revocation to adversely affect a significant number of small entity importers, and that there is a negligible joint probability of all eight conditions holding simultaneously with respect to any particular revocation. (This Agency document is available in the docket of this proposed rule). Furthermore, for the pesticide named in this proposed rule, the Agency knows of no extraordinary circumstances that exist as to the present proposal that would change EPA's previous analysis. Any comments about the Agency's determination should be submitted to EPA along with comments on the proposal, and will be addressed prior to issuing a final rule. In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled *Federalism* (64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive Order to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” This proposed rule directly regulates growers, food processors, food handlers, and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. For these same reasons, the Agency has determined that this proposed rule does not have any “tribal implications” as described in Executive Order 13175, entitled *Consultation and Coordination with Indian Tribal Governments* (65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” “Policies that have tribal implications” is defined in the Executive Order to include regulations that have “substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.” This proposed rule will not have substantial direct effects on tribal governments, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this proposed rule. List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: January 22, 2008. Marty Monell, Acting Director, Office of Pesticide Programs. Therefore, it is proposed that 40 CFR chapter I be amended as follows: PART 180—[AMENDED] 1. The authority citation for part 180 continues to read as follows: Authority: 21 U.S.C. 321(q), 346a and 371. 2. Section 180.142 is amended by revising the entries for “Grape,” “Fruit, pome, group 11,” “Fruit, stone, group 12,” and “Strawberry” in the table in paragraph
(a)to read as follows: § 180.142 2,4-D; tolerances for residues.
(a)*General* . * * * Commodity Parts per million * * * * * Grape 0.05 * * * * * Fruit, pome, group 11 0.05 Fruit, stone, group 12 0.05 * * * * * Strawberry 0.05 * * * * * 3. Section 180.185 is amended by removing the entry for “Vegetable, brassica, leafy, group 5” from the table in paragraph
(d)and adding it alphabetically to the table in paragraph
(a)to read as follows. § 180.185 DCPA; tolerances for residues.
(a)*General* . * * * Commodity Parts per million * * * * * Vegetable, brassica, leafy, group 5 0.05 * * * * * 4. Section 180.204 is amended by revising the table in paragraphs
(a)and
(c)to read as follows: § 180.204 Dimethoate; tolerances for residues.
(a)*General* . * * * Commodity Parts per million Alfalfa, forage 2.0 Alfalfa, hay 2.0 Bean, dry, seed 2.0 Bean, lima 2.0 Bean, snap, succulent 2.0 Blueberry 1 1.0 Broccoli 2.0 Cattle, meat byproducts 0.02 Cauliflower 2.0 Celery 2.0 Citrus, dried pulp 5.0 Corn, field, forage 1.0 Corn, field, grain 0.1 Corn, field, stover 1.0 Corn, pop, grain 0.1 Corn, pop, stover 1.0 Corn, sweet, forage 1.0 Cotton, undelinted seed 0.1 Egg 0.02 Endive 2.0 Goat, meat byproducts 0.02 Grapefruit 2.0 Hog, meat byproducts 0.02 Horse, meat byproducts 0.02 Kale 2.0 Lemon 2.0 Lettuce, leaf 2.0 Melon 1.0 Milk 0.002 Mustard greens 2.0 Orange, sweet 2.0 Pear 2.0 Pea 2.0 Pecan 0.1 Pepper 2.0 Potato 0.2 Poultry, meat byproducts 0.02 Safflower, seed 0.1 Sheep, meat byproducts 0.02 Sorghum, grain, forage 0.1 Sorghum, grain, grain 0.1 Sorghum, grain, stover 0.1 Soybean, seed 0.05 Soybean, forage 2.0 Soybean, hay 2.0 Swiss chard 2.0 Tangerine 2.0 Tomato 2.0 Turnip, tops 2.0 Turnip, roots 0.2 Wheat, forage 2.0 Wheat, grain 0.04 Wheat, hay 2.0 Wheat, straw 2.0 1 There are U.S. registrations as of August 16, 1996.
(c)*Tolerances with regional registrations* . Tolerances with regional registration, as defined in 180.1(m), are established for total residues of dimethoate including its oxygen analog in or on the following food commodities: Commodity Parts per million Asparagus 0.15 Brussels sprouts 5.0 Cherry, sweet 2.0 Cherry, tart 2.0 5. Section 180.206 is amended by revising paragraph
(a)to read as follows: § 180.206 Phorate; tolerances for residues.
(a)*General* . Tolerances are established for the combined residues of the insecticide phorate (O,O-diethyl S[(ethylthio) methyl]phosphorodithioate), phorate sulfoxide, phorate sulfone, phorate oxygen analog, phorate oxygen analog sulfoxide, and phorate oxygen analog sulfone in or on the following food commodities: Commodity Parts per million Bean, dry, seed 0.05 Bean, succulent 0.05 Beet, sugar, roots 0.3 Beet, sugar, tops 3.0 Coffee, green bean 1 0.02 Corn, field, forage 0.5 Corn, field, grain 0.05 Corn, sweet, forage 0.5 Corn, sweet, kernel plus cob with husks removed 0.05 Cotton, undelinted seed 0.05 Hop, dried cones 2.0 Peanut 0.1 Potato 0.2 Sorghum, grain, grain 0.05 Sorghum, grain, stover 0.1 Soybean, seed 0.05 Sugarcane, cane 0.05 Wheat, forage 1.5 Wheat, grain 0.05 Wheat, hay 1.5 Wheat, straw 0.05 1 There are no U.S. registrations as of September 1, 1993, for the use of phorate on the growing crop, coffee. 6. Section 180.241 is amended by revising the heading and paragraphs
(a)and
(c)to read as follows: § 180.241 Bensulide; tolerances for residues.
(a)*General* . Tolerances are established for the residues of S-(O,O-diisopropyl phosphorodithioate) of N- (2-mercaptoethyl) benzenesulfonamide including its oxygen analog S-(O,O-diisopropylphosphorodithioate) of N-(2-mercaptoethyl) benzenesulfonamide in or on the following food commodities: Commodity Parts per million Onion, bulb 0.10 Vegetable, brassica, leafy group 5 0.15 Vegetable, cucurbits group 9 0.15 Vegetable, fruiting group 8 0.10 Vegetable, leafy except brassica group 4 0.15
(c)*Tolerances with regional registrations* . Tolerances with regional registration, as defined in 180.1(m), are established for the residues of S-(O,O-diisopropyl phosphorodithioate) of N-(2-mercaptoethyl) benzenesulfonamide including its oxygen analog S-(O,O-diisopropylphosphorodithioate) of N-(2-mercaptoethyl) benzenesulfonamide in or on the following food commodities: Commodity Parts per million Carrot, roots 0.10 7. Section 180.252 is amended by revising paragraph
(a)to read as follows: §180.252 Tetrachlorvinphos; tolerances for residues.
(a)*General* . Tolerances are established for the combined residues of the insecticide tetrachlorvinphos ((Z)-2-chloro-1-(2,4,5-trichlorophenyl) vinyl dimethyl phosphate) and its metabolites, 1-(2,4,5-trichlorophenyl)-ethanol (free and conjugated forms), 2,4,5-trichloroacetophenone, and 1-(2,4,5-trichlorophenyl)-ethanediol in/on the following food commodities: Commodity Parts per million Expiration/Revocation Date Cattle, fat (of which no more than 0.1 ppm is tetrachlorvinphos per se) 0.2 [date 18 months from the date of Final tolerance publication] Cattle, kidney (of which no more than 0.05 ppm is tetrachlorvinphos per se) 1.0 [date 18 months from the date of Final tolerance publication] Cattle, liver (of which no more than 0.05 ppm is tetrachlorvinphos per se) 0.5 [date 18 months from the date of Final tolerance publication] Cattle, meat (of which no more than 2.0 ppm is tetrachlorvinphos per se) 2.0 [date 18 months from the date of Final tolerance publication] Cattle, meat by products except kidney and liver 1.0 [date 18 months from the date of Final tolerance publication] Egg (of which no more than 0.05 ppm is tetrachlorvinphos per se) 0.2 [date 18 months from the date of Final tolerance publication] Hog, fat (of which no more than 0.1 ppm is tetrachlorvinphos per se) 0.2 [date 18 months from the date of Final tolerance publication] Hog, kidney (of which no more than 0.05 ppm is tetrachlorvinphos per se) 1.0 [date 18 months from the date of Final tolerance publication] Hog, liver (of which no more than 0.05 ppm is tetrachlorvinphos per se) 0.5 [date 18 months from the date of Final tolerance publication] Hog, meat (of which no more than 2.0 ppm is tetrachlorvinphos per se) 2.0 [date 18 months from the date of Final tolerance publication] Hog, meat byproducts except kidney and liver 1.0 [date 18 months from the date of Final tolerance publication] Milk, fat (reflecting negligible residues in whole milk and of which no more than 0.05 ppm is tetrachlorvinphos per se) 0.05 [date 18 months from the date of Final tolerance publication] Poultry, fat (of which no more than 7.0 ppm is tetrachlorvinphos per se) 7.0 [date 18 months from the date of Final tolerance publication] Poultry, liver (of which no more than 0.05 ppm is tetrachlorvinphos per se) 2.0 [date 18 months from the date of Final tolerance publication] Poultry, meat (of which no more than 3.0 ppm is tetrachlorvinphos per se) 3.0 [date 18 months from the date of Final tolerance publication] Poultry, meat byproducts except liver 2.0 [date 18 months from the date of Final tolerance publication] 8. Section 180.349 is amended by revising paragraph
(a)and the table in paragraph
(c)to read as follows: § 180.349 Fenamiphos; tolerances for residues.
(a)*General* . Tolerances are established for the combined residues of the nematocide fenaminphos, (ethyl 3-methyl-4-(methylthio) phenyl (1-methylethyl) phosphoramidate, and its cholinesterase inhibiting metabolites ethyl 3-methyl-4-(methylsulfinyl) phenyl (1-methylethyl) phosphoramidate and ethyl 3-methyl-4-(methylsulfonyl) phenyl (1-methylethyl) phosporamidate in or on the following food commodities: Commodity Parts per million Expiration/Revocation Date Apple 0.25 December 31, 2009 Banana 1 0.10 None Brussels sprouts 0.05 December 31, 2009 Cabbage 0.10 December 31, 2009 Cherry, sweet 0.25 December 31, 2009 Cherry, tart 0.25 December 31, 2009 Citrus, dried pulp 2.5 None Citrus, oil 25.0 None Eggplant 0.05 December 31, 2009 Fruit, citrus, group 10 1 0.50 None Garlic 1 0.50 None Grape 1 0.10 None Grape, raisin 0.30 None Okra 0.30 December 31, 2009 Peach 0.25 December 31, 2009 Peanut 1.0 December 31, 2009 Pineapple 1 0.30 None Raspberry 0.10 December 31, 2009 Strawberry 0.60 December 31, 2009 1 There are no U.S. registrations as of December 31, 2009.
(c)*Tolerances with regional registrants* . * * * Commodity Parts per million Expiration/Revocation Date Asparagus 0.02 December 31, 2009 Beet, garden roots 1.5 December 31, 2009 Beet, garden, tops 1.0 December 31, 2009 Bok choy 0.50 December 31, 2009 Kiwifruit 0.10 December 31, 2009 Pepper, nonbell 0.60 December 31, 2009 9. Section 180.352 is revised to read as follows: § 180.352 Terbufos; tolerances for residues.
(a)*General* . Tolerances are established for the combined residues of the insecticide terbufos (phosphorodithioic acid, S-(t-butylthio)methyl O,O-diethyl ester) and its phosphorylated (cholinesterase-inhibiting) metabolites (phosphorothioic acid, S-(t-butylthio)methyl O,O-diethyl ester; phosphorothioic acid, S-(t-butylsulfinyl)methyl O,O-diethyl ester; phosphorothioic acid, S-(t-butylsulfonyl)methyl O,O-diethyl ester; phosphorodithioic acid, S-(t-butylsulfinyl)methyl O,O-diethyl ester; and phosphorodithioic acid, S-(t-butylsulfonyl)methyl O,O-diethyl ester) in or on food commodities: Commodity Parts per million Banana 0.025 Beet, sugar, roots 0.05 Beet, sugar, tops 0.1 Coffee, green bean 1 0.05 Corn, field, forage 0.5 Corn, field, grain 0.5 Corn, field, stover 0.5 Corn, pop, grain 0.5 Corn, pop, stover 0.5 Corn, sweet, kernel plus cob with husks removed 0.05 Corn, sweet, forage 0.5 Corn, sweet, stover 0.5 Sorghum, grain, forage 0.5 Sorghum, grain, grain 0.05 Sorghum, grain, stover 0.5 1 There are no U. S. registrations as of August 2, 1995, for the use of terbufos on the growing crop, coffee.
(b)*Section 18 emergency exemptions* . [Reserved]
(c)*Tolerances with regional registrations* . [Reserved]
(d)*Indirect or inadvertent residues* . [Reserved] 10. Section 180.353 is amended by revising the table in paragraph
(a)to read as follows: § 180.353 Desmedipham; tolerances for residues.
(a)*General* . Commodity Parts per million Beet, garden, roots 0.05 Beet, garden, tops 1.0 Beet, sugar, roots 0.1 Beet, sugar, tops 5.0 Spinach 6.0 11. Section 180.412 is amended by revising the table in paragraph
(a)to read as follows: § 180.412 Sethoxydim; tolerances for residues.
(a)*General* . * * * Commodity Parts per million Alfalfa, forage 40 Alfalfa, hay 40 Almond, hulls 2.0 Apricot 0.2 Apple, wet pomace 0.8 Asparagus 4.0 Bean, succulent 15 Beet, sugar, molasses 10 Beet, sugar, tops 3.0 Blueberry 4.0 Borage, meal 10 Borage, seed 6.0 Buckwheat, flour 25 Buckwheat, grain 19 Caneberry subgroup 13 A 5.0 Canola, meal 40 Canola, seed 35 Cattle, fat 0.2 Cattle, meat 0.2 Cattle, meat byproducts 1.0 Cherry, sweet 0.2 Cherry, tart 0.2 Citrus, dried pulp 1.5 Clover, forage 35 Clover, hay 55 Coriander, leaves 4.0 Corn, field, fodder 2.5 Corn, field, grain 0.5 Corn, field, stover 2.0 Corn, sweet, forage 3.0 Corn, sweet, kernel plus cob with husk removed 0.4 Corn, sweet, stover 3.5 Cotton, undelinted seed 5.0 Cowpea, forage 15 Cowpea, hay 50 Cranberry 2.5 Dillweed, fresh leaves 10 Egg 2.0 Flax, seed 5.0 Fruit, citrus, group 10 0.5 Fruit, pome, group 11 0.2 Goat, fat 0.2 Goat, meat 0.2 Goat, meat byproducts 1.0 Grape 1.0 Grape, raisin 2.0 Hog, fat 0.2 Hog, meat 0.2 Hog, meat byproducts 1.0 Horse, fat 0.2 Horse, meat 0.2 Horse, meat byproducts 1.0 Juneberry 5.0 Lingonberry 5.0 Milk 0.5 Nectarine 0.2 Nut, tree, group 14 0.2 Okra 2.5 Pea and bean, dried shelled, except soybean, subgroup 6C 25 Pea, field, hay 40 Pea, field, vines 20 Pea, succulent 10 Peach 0.2 Peanut 25 Peppermint, tops 30 Pistachio 0.2 Potato granules/flakes 8.0 Potato waste, processed 8.0 Poultry, fat 0.2 Poultry, meat 0.2 Poultry, meat byproducts 2.0 Radish, tops 4.5 Rapeseed, meal 40 Rapeseed, seed 35 Safflower, seed 15 Salal 5.0 Sheep, fat 0.2 Sheep, meat 0.2 Sheep, meat byproducts 1.0 Soybean, hay 10 Soybean, seed 16 Spearmint, tops 30 Strawberry 10 Sunflower, meal 20 Sunflower, seed 7.0 Turnip, tops 5.0 Vegetable, brassica, leafy, group 5 5.0 Vegetable, bulb, group 3 1.0 Vegetable, cucurbit, group 9 4.0 Vegetable, fruiting, group 8 4.0 Vegetable, leafy, except brassica, group 4 4.0 Vegetable, root and tuber, group 1 4.0 [FR Doc. E8-2094 Filed 2-5-08; 8:45 am] BILLING CODE 6560-50-S FEDERAL COMMUNICATIONS COMMISSION 47 CFR Part 1 [WC Docket No. 07-245; FCC 07-187] Implementation of Section 224 of the Act; Amendment of the Commission's Rules and Policies Governing Pole Attachments AGENCY: Federal Communications Commission. ACTION: Proposed rule. SUMMARY: In this document, the Commission seeks comment on whether to amend its rules governing pole attachments, which are designed to ensure the attachment of facilities of cable television systems and telecommunications carriers to utility poles, ducts, conduits, or rights-of-way (collectively, “pole attachments”) at just and reasonable rates, terms and conditions. The Commission has received petitions for rulemaking from Fibertech Networks, LLC and United States Telecom Association seeking review of the current pole attachment rules, which petitioners and commenters claim are inadequate in scope or no longer accord with developing technology and business models. The Commission seeks to resolve questions regarding appropriate regulation of pole attachment rates, terms, and conditions of access. DATES: Comments are due March 7, 2008 and Reply Comments are due March 24, 2008. Written comments on the Paperwork Reduction Act proposed information collection requirements must be submitted by the public, Office of Management and Budget (OMB), and other interested parties on or before April 7, 2008. ADDRESSES: You may submit comments, identified by WC Docket No. 07-245, by any of the following methods: • *Federal eRulemaking Portal:* *http://www.regulations.gov.* Follow the instructions for submitting comments. • *Federal Communications Commission's Web site: http://www.fcc.gov/cgb/ecfs/.* Follow the instructions for submitting comments. • *E-mail: ecfs@fcc.gov,* and include the following words in the body of the message, “get form.” A sample form and directions will be sent in response. Include the docket number in the subject line of the message. • *Mail:* Secretary, Federal Communications Commission, 445 12th Street SW., Washington, DC 20554. • *People with Disabilities:* Contact the FCC to request reasonable accommodations (accessible format documents, sign language interpreters, CART, etc.) by e-mail: *FCC504@fcc.gov* or phone: 202-418-0530 or TTY: 202-418-0432. For detailed instructions for submitting comments and additional information on the rulemaking process, see the SUPPLEMENTARY INFORMATION section of this document. In addition to filing comments with the Secretary, a copy of any comments on the Paperwork Reduction Act information collection requirements contained herein should be submitted to the Federal Communications Commission via e-mail to *PRA@fcc.gov* and to Nicholas A. Fraser, Office of Management and Budget, via e-mail to *Nicholas_A._Fraser@omb.eop.gov* or via fax at 202-395-5167. FOR FURTHER INFORMATION CONTACT: Jonathan Reel, Wireline Competition Bureau,
(202)418-1580. For additional information concerning the Paperwork Reduction Act information collection requirements contained in this document, contact Jerry R. Cowden at
(202)418-0447, or via the Internet at *PRA@fcc.gov.* SUPPLEMENTARY INFORMATION: Pursuant to §§ 1.415 and 1.419 of the Commission's rules, 47 CFR 1.415 and 1.419, interested parties may file Comments on or before March 7, 2008 and Reply Comments on or before March 24, 2008. Comments may be filed using:
(1)The Commission's Electronic Comment Filing System (ECFS),
(2)the Federal Government's eRulemaking Portal, or
(3)by filing paper copies. *See Electronic Filing of Documents in Rulemaking Proceedings,* 63 FR 24121, May 1, 1998. • *Electronic Filers:* Comments may be filed electronically using the Internet by accessing the ECFS: *http://www.fcc.gov/cgb/ecfs/* or the Federal eRulemaking Portal: *http://www.regulations.gov.* Filers should follow the instructions provided on the Web site for submitting comments. • For ECFS filers, if multiple docket or rulemaking numbers appear in the caption of this proceeding, filers must transmit one electronic copy of the comments for each docket or rulemaking number referenced in the caption. In completing the transmittal screen, filers should include their full name, U.S. Postal Service mailing address, and the applicable docket or rulemaking number. Parties may also submit an electronic comment by Internet e-mail. To get filing instructions, filers should send an e-mail to *ecfs@fcc.gov,* and include the following words in the body of the message, “get form.” A sample form and directions will be sent in response. • *Paper Filers:* Parties who choose to file by paper must file an original and four copies of each filing. If more than one docket or rulemaking number appears in the caption of this proceeding, filers must submit two additional copies for each additional docket or rulemaking number. Filings can be sent by hand or messenger delivery, by commercial overnight courier, or by first-class or overnight U.S. Postal Service mail (although we continue to experience delays in receiving U.S. Postal Service mail). All filings must be addressed to the Commission's Secretary, Office of the Secretary, Federal Communications Commission. • The Commission's contractor will receive hand-delivered or messenger-delivered paper filings for the Commission's Secretary at 236 Massachusetts Avenue, NE., Suite 110, Washington, DC 20002. The filing hours at this location are 8 a.m. to 7 p.m. All hand deliveries must be held together with rubber bands or fasteners. Any envelopes must be disposed of *before* entering the building. • Commercial overnight mail (other than U.S. Postal Service Express Mail and Priority Mail) must be sent to 9300 East Hampton Drive, Capitol Heights, MD 20743. • U.S. Postal Service first-class, Express, and Priority mail must be addressed to 445 12th Street, SW., Washington, DC 20554. *People with Disabilities:* To request materials in accessible formats for people with disabilities (braille, large print, electronic files, audio format), send an e-mail to *fcc504@fcc.gov* or call the Consumer & Governmental Affairs Bureau at 202-418-0530 (voice), 202-418-0432 (TTY). Initial Paperwork Reduction Act of 1995 Analysis This document does not contain proposed information collection requirements subject to the Paperwork Reduction Act of 1995, Public Law 104-13. In addition, therefore, it does not contain any proposed information collection burden “for small business concerns with fewer than 25 employees,” pursuant to the Small Business Paperwork Relief Act of 2002, Public Law 107-198, see 44 U.S.C. 3506(c)(4). Synopsis of the Notice of Proposed Rulemaking Implementation of Section 224 of the Act; Amendment of the Commission's Rules and Policies Governing Pole Attachments 1. In this Notice of Proposed Rulemaking ( *NPRM* ), the Commission seeks comment with regard to implementation of section 224 of the Communications Act of 1934, as amended (Act). Section 224 confers on cable television systems and telecommunications carriers the right to pole attachments at just and reasonable rates, terms and conditions. In the Telecommunications Act of 1996 (1996 Act), Congress expanded the definition of a “pole attachment” for purposes of section 224 to include not only poles but also “any attachment” to a “duct, conduit, or right-of-way owned or controlled by a utility.” The Commission seeks to ensure that its regulatory framework remains current and faithful to the pro-competitive, market-opening provisions of the Act in light of experience over the last decade, advances in technology, and developments in the markets for telecommunications and video services. 2. *Rate Regulation.* Congress first directed the Commission to ensure that the rates, terms, and conditions for pole attachments by cable television systems were just and reasonable in 1978 when it added section 224 to the Act. Then, as now, the statute provided that the Commission will regulate pole attachments except where such matters are regulated by a state. Eighteen states and the District of Columbia have certified that they regulate pole attachments, and thus the Commission does not regulate pole attachments in those states. In a series of orders, the Commission implemented a formula that cable television system attachers and utilities could use to determine a just and reasonable rate, and procedures for resolving rate complaints. In 1987, the U.S. Supreme Court found that the formula the Commission devised for pole attachments by cable television systems (the cable rate) did not result in an unconstitutional “taking.” Congress expanded the reach of section 224 in several notable ways in the 1996 Act. Congress granted attachers an affirmative right to access utility poles. The 1996 Act also added ducts, conduits, and rights-of-way to the facilities covered by section 224. Congress included a proviso, however, that utilities providing electric service may deny access, on a nondiscriminatory basis, where there is insufficient capacity and for reasons of safety, reliability and generally applicable engineering purposes. Further, Congress added “telecommunications carrier” as a category of attacher under section 224. Congress established two separate provisions governing the maximum rates for pole attachments—one for attachments used by “telecommunications carriers” to provide telecommunications services (the telecommunications rate), and another for attachments used “solely to provide cable service.” For purposes of section 224, Congress excluded incumbent local exchange carriers
(LECs)from the definition of “telecommunications carriers.” 3. *Access Regulation.* To implement the new section 224 access requirements of the 1996 Act, the Commission adopted five rules of general applicability and several broad policy guidelines addressing such issues as capacity expansion, reservation of space by utilities for their own use, and the right of non-electric utilities to deny access for capacity or safety reasons. The Commission declined at that time to mandate specific access requirements, concluding instead that the reasonableness of particular conditions of access imposed by a utility should be resolved on a case-specific basis. The Commission stated that it would monitor the effect of the case-specific approach, and would propose specific rules at a later date if conditions warranted. The Commission also concluded that section 224's principle of nondiscrimination required utilities to expand capacity for attachers as they would for themselves. In *Southern Co.* v. *FCC,* 293 F.3d 1338, 1346-47 (11th Cir. 2002), the U.S. Court of Appeals for the Eleventh Circuit rejected the Commission's requirement that utilities expand capacity for attachers, holding that, under the plain language of section 224 of the Act, “[w]hen it is agreed that capacity is insufficient, there is no obligation to provide third parties with access” to poles. The Eleventh Circuit also held, however, that the term “insufficient capacity” is not defined by statute and is ambiguous, and that utilities do not “enjoy the unfettered discretion to determine when capacity is insufficient.” *Southern,* 293 F.3d at 1348. 4. *Petitions for Rulemaking.* On December 7, 2005, Fibertech Networks, LLC (Fibertech) petitioned the Commission to conduct a rulemaking to adopt seven “standard practices” for pole and conduit access. On October 11, 2005, United States Telecom Association (USTelecom) petitioned the Commission to conduct a rulemaking to consider whether, as providers of telecommunications services, incumbent LECs are entitled to regulated pole attachment rates. Among the numerous ex parte filings submitted in these dockets, Time Warner Telecom, Inc.
(TWTC)filed a White Paper seeking adoption of a single pole attachment rate for both cable television systems and telecommunications carriers in order to remove regulatory bias from investment decisions regarding deployment of broadband and other services. 5. *Market Forces and Change.* The Commission inquires about the current state of pole attachments, ducts, conduits, and rights-of-way, and the relationship between these facilities and the competitive telecommunications market. It seeks data on the nature and scope of pole attachments by the various types of providers, and inquires about the difference in pole attachment prices paid by cable systems, incumbent LECs, and competing telecommunications carriers that provide the same or similar services. The Commission asks, for example, in what ways do pole attachments affect the expansion of broadband Internet access service and how do pole attachments by cable systems and providers of telecommunications services affect competition to deliver services. Over the last few years, the Commission has recognized that the once-clear distinction between “cable television systems” and “telecommunications carriers” has blurred as each type of company enters markets for the delivery of services historically associated with the other. 6. The Commission also seeks comment regarding possible changes in bargaining power between electric utilities and incumbent LECs, and whether pole attachment rates paid by incumbent LECs could affect the vitality of competition to deliver telecommunications, video services, and broadband Internet access service. The Commission seeks comment on developments related to rates, costs, and bargaining power between electric utilities and incumbent LECs. The Commission seeks comment regarding “joint use agreements,” including the number and percentage of poles that are owned or managed jointly, and how to evaluate when ownership and control of poles is truly “joint.” The Commission also seeks comment on claims that small and rural incumbent LECs are particularly at a disadvantage. 7. *Authority To Regulate Pole Attachments.* The Commission seeks general comment regarding the contours of the Commission's flexibility to interpret section 224. Section 224(b)(1) states that “the Commission shall regulate the rates, terms, and conditions for pole attachments to provide that such rates, terms, and conditions are just and reasonable” and section 224(a)(4) states that “[t]he term ‘pole attachment’ means any attachment by a cable television system or provider of telecommunications service to a pole, duct, conduit, or right-of-way owned or controlled by a utility.” In addition to this broad mandate, and as noted above, section 224 also provides two separate and explicit rate formulas. One rate—the cable rate—applies to cable television systems' attachments used solely to provide cable service; the other—the telecommunications rate—applies to both cable systems and telecommunications carriers' attachments used to provide telecommunications services. 8. The statute does not specify which of these rates, if either, should apply to transmission of information access services. The Commission seeks comment on the extent to which the current cable rate formula, whose space factor does not include unusable space, results in a subsidized rate, and, if so, whether cable operators should continue to receive such subsidized pole attachment rate at the expense of electric consumers. The Commission seeks comment on whether cable operators should continue to qualify for the cable rate where they offer multiple services in addition to cable service, and whether all telecommunications carriers must pay the telecommunications rate, regardless of what other services they may provide over their attachments. The Commission asks under what circumstances the Commission may adopt another rate, what is the extent of the Commission's ability to modify how the cable and telecommunications rates are applied. The Commission further asks whether wireless carriers are entitled to attach equipment at the subsection
(e)telecommunications rate, or whether their attachments differ to such an extent that another rate would be more reasonable. The Commission seeks comment on the reach of its general authority to regulate pole attachments pursuant to section 224(b), asking whether it has the authority under section 224 to regulate pole attachment rates for all providers of telecommunications services, including incumbent LECs. 9. *A Unified Pole Attachment Rate and the Existing Cable and Telecommunications Rates.* The Commission seeks comment on the statutory limits, if any, to unifying the pole attachment rate paid by both cable systems and telecommunications carriers when their pole attachments are used to provide broadband Internet access service. TWTC proposes that the Commission should eliminate the telecommunications rate and apply the cable rate to all pole attachments, and argues that the Commission should use its broad authority to apply the cable rate to all pole attachments. TWTC further argues that section 224(e)(1) mandates that rates must be nondiscriminatory, and that where cost allocation guidelines yield discriminatory rates, that the nondiscrimination mandate trumps the cost allocation guidelines. The Commission questions TWTC's assertion that the cable rate should apply to all pole attachments, particularly because the cable rate does not include an allocation of the cost of unusable space. The Commission seeks comment on the advantages and disadvantages of a unitary rate for all providers of broadband Internet access service, and the appropriate level of such rate. 10. *The Rights of Incumbent LECs under Section 224.* The Commission seeks comment on the extent of its authority to regulate pole attachment rates for incumbent LECs. In the Local Competition Order and succeeding orders, and in the rules implementing section 224, the Commission interpreted the exclusion of incumbent LECs from the term “telecommunications carrier” (and from the corresponding right to attach to utility poles) to mean that section 224 does not apply to attachment rates paid by incumbent LECs. USTelecom asks the Commission to revisit that interpretation. USTelecom acknowledges that incumbent LECs are excluded from the section 224 definition of “telecommunications carrier.” USTelecom argues, however, that sections 224(b)(1) and 224(a)(4) provide an independent right to reasonable rates, terms, and conditions for any pole attachment by a provider of telecommunications service, and that the statute thus mandates the Commission to apply the “just and reasonable” standard to pole attachments for all such providers, including incumbent LECs. USTelecom asks the Commission to revise any pole attachment rule that conflates “right of access” with “just and reasonable rates, terms, and conditions.” USTelecom argues that Congress could have required just and reasonable rates only for “a cable television system or any telecommunications carrier”—the phrase used to specify the right of access—but Congress chose instead to afford such protection to “any attachment by a cable television system or provider of telecommunications service.” Therefore, according to USTelecom, because the Commission's current rules ignore this distinction, they only partially implement section 224. Under USTelecom's proposal, although only cable television systems and “telecommunications carriers” would be assured of access to poles, all attaching “providers of telecommunications service,” including incumbent LECs, would be assured of just and reasonable rates. The Commission seeks comment on the view that, under section 224, “access” and “rates, terms, and conditions” are severable rights that should be implemented separately. 11. *Rate Level.* The Commission seeks comment on whether it should move toward a single rate for pole attachments used for the same or similar services, and whether adopting a single pole attachment rate would promote the goals of the Act with regard to competition, deregulation, and the deployment of advanced telecommunications capability. TWTC maintains that adopting a single attachment rate for both cable television systems and telecommunication carriers would remove regulatory bias from investment decisions regarding deployment of broadband and other services. TWTC also notes that both cable television systems and telecommunications carriers pay a single rate for using conduit, which suggests that having two different rates for pole attachments is inherently baseless and discriminatory. TWTC further claims having two rates discourages investment in broadband networks, and for these reasons proposes that the Commission eliminate the telecommunications rate and apply the cable rate to all wire and cable pole attachments. The Commission seeks comment on whether having a single pole attachment rate better achieves the goals of the Act than having two separate rates, and asks whether the current pole attachment rate structure unreasonably discriminates between similarly situated entities or otherwise distorts the market. 12. The Commission also seeks comment regarding whether having two rates leads to recurring disputes over which rate to apply, and solicits general comment on whether the current system is clear, certain, and enforceable, and to what extent there is a perceived uncertainty about which rate to apply. The Commission adopted specific formulas implementing the cable rate and telecommunications rate, which differ only in the manner in which the costs associated with the unusable portion of the pole are allocated. Both of these formulas include a component for the net costs of a bare pole and the carrying charge rate. Carrying charges are the costs incurred by the utility in owning and maintaining poles regardless of the presence of pole attachments. TWTC argues that the similarities in the Commission's cable rate and telecommunications rate formulas are inappropriate, in light of textual differences between section 224(d) and section 224(e) regarding costs. In particular, TWTC contends that the telecommunications rate includes elements not mentioned in section 224(e), citing
(1)the “carrying charges” and
(2)the “rate of return” element. TWTC alleges that such costs “bear no relation” to the cost of providing space for attachment and should be eliminated from the telecommunications rate. The Commission seeks comment on the desirability of moving to a single pole attachment rate and also on the appropriate level of such a single rate. The Commission invites comment on the possible effect on small entities from adopting a single rate. 13. The Commission seeks comment on USTelecom's suggestion that the default “just and reasonable” attachment rate for incumbent LECs should be the telecommunications rate. The Commission asks if it adopts rules or guidelines for jointly owned poles how it should consider variables such as the proportion of poles owned, the division of maintenance costs and responsibilities, the income each party receives from other attachers, and similar variables. The Commission also seeks comment regarding whether, given the historical and continuing relationship regarding pole ownership between electric utilities and incumbent LECs, a “just and reasonable” rate for incumbent LECs should be determined by a method other than by applying a rate formula, and seeks comment on alternative approaches. The Commission further seeks comment on whether the historical relationship between incumbent LECs and power companies suggests that it should adopt a purely procedural solution instead of applying a rate formula, such as requiring parties to engage in mediated negotiation or arbitration subject to Commission review. 14. Wireless telecommunications carriers urge the Commission to adopt rules explicitly stating that the Commission's telecommunications rate formula applies to the attachment of wireless devices. The Commission has found no clear indication that the rules could not accommodate wireless attachers' use of poles. The Commission now seeks comment on whether, when they are “telecommunications carriers,” wireless providers are entitled to the telecommunications rate as a matter of law, or whether the Commission should adopt a rate specifically for wireless pole attachments. The Commission asks whether, if a wireless facility uses more than the presumptive one foot of space, the per-foot rate could simply be doubled, trebled, or otherwise multiplied as required. The Commission also asks whether, if wireless providers are permitted to attach facilities to pole tops, pole owners should receive a higher rate of compensation, because unlike lateral space, each pole has only one top. The Commission also seeks comment on the extent to which municipalities lease pole attachments for municipal broadband purposes or other services such as telecommunications services, and seeks comment on the impact that the tentative conclusion below might have on municipalities seeking to provide their residents municipal broadband or other services like telecommunications services. 15. *Tentative Conclusion for Broadband Internet Access Service.* Due to the importance of promoting broadband deployment and the importance of technological neutrality, the Commission tentatively concludes that all categories of providers should pay the same pole attachment rate for all attachments used for broadband Internet access service, and the Commission seeks comment on that tentative conclusion. Section 706 of the Act directs the Commission to promote the deployment of broadband infrastructure, and this directive leads the Commission to separate out those pole attachments that are used to offer broadband Internet access service from those used for other services. As a policy matter, the Commission tentatively concludes that the critical need to create even-handed treatment and incentives for broadband deployment would warrant the adoption of a uniform rate for all pole attachments used for broadband Internet access service. Additionally, the Commission concludes that the rate should be higher than the current cable rate, yet no greater than the telecommunications rate; seeks comment on these tentative conclusions; and seeks comment on the possible economic effect on small entities of adopting this tentative conclusion. 16. *Terms and Conditions of Access.* When the Commission adopted general rules governing requests for access pursuant to the 1996 Act, it declined to regulate specific techniques for pole and conduit modification. Rather, the Commission concluded that the reasonableness of particular conditions of access imposed by a utility should be resolved on a case-specific basis. In the record developed in response to the Fibertech Petition, a number of concerns have been expressed regarding terms and conditions of access to pole attachments, and the Commission seeks comment on these concerns. For example, commenters raised concerns regarding searches and surveys of both poles and conduit, including related information management practices. Parties also expressed concerns regarding performance of make-ready work, including timeliness, safety, capacity, and the use of boxing and extension arms. Sunesys supports Fibertech's position, but also submits its own plan to limit survey and make-ready work to six months, proposing that utility-approved contractors could perform the work if they were required to meet the deadline. Other commenters also recommended the use of qualified third-party contract workers. Certain commenters raised additional issues regarding access to in-building ducts, conduit, and rights-of-way, including access to incumbent LEC central offices. Parties also express concern regarding practices relating to drop lines and poles. These are illustrative categories of access concerns, and the Commission seeks comment on these and any other pole attachment access concerns, such as concerns about the process for obtaining access. 17. The Commission also seeks comment on allegations or concerns regarding unauthorized attachments, or attachments that have been installed without a lawful attachment agreement. The Commission seeks comment on the prevalence of this practice, and whether the Commission's existing enforcement mechanisms are sufficient to address any unlawful practices by attachers and ensure the safety and reliability of critical electric infrastructure. Commenters are asked to address whether, in addition to the right, under section 224(f)(2) of the Act, of a utility to deny access to poles on a nondiscriminatory basis for reasons of safety, reliability and generally applicable engineering purposes, specific enforceable safety requirements should be adopted. For example, commenters are asked to address to what extent safety codes, such as the National Electrical Safety Code, should apply to all attachers, and whether the Commission's enforcement authority can or should be used to address alleged violations of such codes. Finally, the Commission seeks comment on the general usefulness of rules, presumptions, or guidelines, as opposed to case-specific adjudication, and seeks comment on how these alternative approaches to resolving access issues may affect small entities. Ex Parte Presentations 18. The rulemaking this *NPRM* initiates shall be treated as a “permit-but-disclose” proceeding in accordance with the Commission's ex parte rules. Persons making oral ex parte presentations are reminded that memoranda summarizing the presentations must contain summaries of the substance of the presentations and not merely a listing of the subjects discussed. More than a one or two sentence description of the views and arguments presented generally is required. Other requirements pertaining to oral and written presentations are set forth in § 1.1206(b) of the Commission's rules. Initial Regulatory Flexibility Analysis 19. As required by the Regulatory Flexibility Act of 1980, the Commission has prepared an Initial Regulatory Flexibility Analysis
(IRFA)of the possible significant economic impact on small entities of the policies and rules addressed in this document. The IRFA is set forth separately below. Written public comments are requested on this IRFA. Comments must be identified as responses to the IRFA. Comments are due on March 7, 2008 and Reply Comments are due on March 24, 2008. Paperwork Reduction Act 20. This document contains proposed new or modified information collection requirements. The Commission, as part of its continuing effort to reduce paperwork burdens, invites the general public and the Office of Management and Budget
(OMB)to comment on the information collection requirements contained in this document, as required by the Paperwork Reduction Act of 1995, Public Law 104-13. In addition, pursuant to the Small Business Paperwork Relief Act of 2002, Public Law 107-198, the Commission seeks specific comment on how it might further reduce the information collection burden for small business concerns with fewer than 25 employees. Initial Regulatory Flexibility Analysis 21. As required by the Regulatory Flexibility Act of 1980, as amended (RFA), the Commission has prepared this present Initial Regulatory Flexibility Analysis
(IRFA)of the possible significant economic impact on a substantial number of small entities by the policies and rules proposed in this *NPRM* . Written public comments are requested on this IRFA. Comments must be identified as responses to the IRFA. Comments are due March 7, 2008 and Reply Comments are due March 24, 2008. The Commission will send a copy of the *NPRM,* including this IRFA, to the Chief Counsel for Advocacy of the Small Business Administration (SBA). In addition, the *NPRM* and IRFA (or summaries thereof) will be published in the **Federal Register** . A. Need for, and Objectives of, the Proposed Rules 22. The *NPRM* seeks comment on a variety of issues relating to implementation of section 224 pole attachment rules in light of increasing intermodal competition in the decade since the Commission began to implement the 1996 Act. Specifically, the *NPRM* asks whether existing rules governing pole attachment rates remain appropriate in light of competition in the marketplace today; whether section 224 confers rights on incumbent local exchange carriers (LECs), including regulation of the rates they pay for pole attachments; and whether it would be appropriate to adopt specific rules regarding certain non-price terms and conditions associated with section 224 access rights. With regard to rates, the *NPRM* tentatively concludes that all attachments used for broadband Internet access service should be subject to a single rate, regardless of the platform over which those services are provided. B. Legal Basis 23. The legal basis for any action that may be taken pursuant to the NPRM is contained in sections 1, 4(i), 4(j), 224, 303 and 403 of the Communications Act of 1934, as amended, 47 U.S.C. 154(i)-(j), 224, 303, 403. C. Description and Estimate of the Number of Small Entities to Which the Proposed Rules May Apply 24. The RFA directs agencies to provide a description of and, where feasible, an estimate of the number of small entities that may be affected by the proposed rules. The RFA generally defines the term “small entity” as having the same meaning as the terms “small business,” “small organization,” and “small governmental jurisdiction.” In addition, the term “small business” has the same meaning as the term “small business concern” under the Small Business Act. A small business concern is one which:
(1)Is independently owned and operated;
(2)is not dominant in its field of operation; and
(3)satisfies any additional criteria established by the Small Business Administration (SBA). 25. Small Businesses. Nationwide, there are a total of approximately 22.4 million small businesses, according to SBA data. 26. Small Organizations. Nationwide, there are approximately 1.6 million small organizations. 27. Small Governmental Jurisdictions. The term “small governmental jurisdiction” is defined generally as “governments of cities, towns, townships, villages, school districts, or special districts, with a population of less than fifty thousand.” Census Bureau data for 2002 indicate that there were 87,525 local governmental jurisdictions in the United States. The Commission estimates that, of this total, 84,377 entities were “small governmental jurisdictions.” Thus, the Commission estimates that most governmental jurisdictions are small. 1. Telecommunications Service Entities a. Wireline Carriers and Service Providers 28. We have included small incumbent LECs in this present RFA analysis. As noted above, a “small business” under the RFA is one that, inter alia, meets the pertinent small business size standard (e.g., a telephone communications business having 1,500 or fewer employees), and “is not dominant in its field of operation.” The SBA's Office of Advocacy contends that, for RFA purposes, small incumbent LECs are not dominant in their field of operation because any such dominance is not “national” in scope. The Commission has therefore included small incumbent LECs in this RFA analysis, although the Commission emphasizes that this RFA action has no effect on Commission analyses and determinations in other, non-RFA contexts. 29. Incumbent LECs. Neither the Commission nor the SBA has developed a small business size standard specifically for incumbent LECs. The appropriate size standard under SBA rules is for the category Wired Telecommunications Carriers. Under that size standard, such a business is small if it has 1,500 or fewer employees. According to Commission data, 1,303 carriers have reported that they are engaged in the provision of incumbent local exchange services. Of these 1,303 carriers, an estimated 1,020 have 1,500 or fewer employees and 283 have more than 1,500 employees. Consequently, the Commission estimates that most providers of incumbent local exchange service are small businesses that may be affected by the Commission's action. 30. Competitive LECs, Competitive Access Providers (CAPs), “Shared-Tenant Service Providers,” and “Other Local Service Providers.” Neither the Commission nor the SBA has developed a small business size standard specifically for these service providers. The appropriate size standard under SBA rules is for the category Wired Telecommunications Carriers. Under that size standard, such a business is small if it has 1,500 or fewer employees. According to Commission data, 859 carriers have reported that they are engaged in the provision of either competitive access provider services or competitive LEC services. Of these 859 carriers, an estimated 741 have 1,500 or fewer employees and 118 have more than 1,500 employees. In addition, 16 carriers have reported that they are “Shared-Tenant Service Providers,” and all 16 are estimated to have 1,500 or fewer employees. In addition, 44 carriers have reported that they are “Other Local Service Providers.” Of the 44, an estimated 43 have 1,500 or fewer employees and one has more than 1,500 employees. Consequently, the Commission estimates that most providers of competitive local exchange service, competitive access providers, “Shared-Tenant Service Providers,” and “Other Local Service Providers” are small entities. 31. Interexchange Carriers (IXCs). Neither the Commission nor the SBA has developed a small business size standard specifically for providers of interexchange services. The appropriate size standard under SBA rules is for the category Wired Telecommunications Carriers. Under that size standard, such a business is small if it has 1,500 or fewer employees. According to Commission data, 330 carriers have reported that they are engaged in the provision of interexchange service. Of these, an estimated 309 have 1,500 or fewer employees and 21 have more than 1,500 employees. Consequently, the Commission estimates that the majority of IXCs are small entities that may be affected by Commission action. b. Wireless Telecommunications Service Providers 32. Below, for those services subject to auctions, the Commission notes that, as a general matter, the number of winning bidders that qualify as small businesses at the close of an auction does not necessarily represent the number of small businesses currently in service. Also, the Commission does not generally track subsequent business size unless, in the context of assignments or transfers, unjust enrichment issues are implicated. 33. Wireless Service Providers. The SBA has developed a small business size standard for wireless firms within the two broad economic census categories of “Paging” and “Cellular and Other Wireless Telecommunications.” Under both SBA categories, a wireless business is small if it has 1,500 or fewer employees. For the census category of Paging, Census Bureau data for 2002 show that there were 807 firms in this category that operated for the entire year. Of this total, 804 firms had employment of 999 or fewer employees, and three firms had employment of 1,000 employees or more. Thus, under this category and associated small business size standard, the majority of firms can be considered small. For the census category of Cellular and Other Wireless Telecommunications, Census Bureau data for 2002 show that there were 1,397 firms in this category that operated for the entire year. Of this total, 1,378 firms had employment of 999 or fewer employees, and 19 firms had employment of 1,000 employees or more. Thus, under this second category and size standard, the majority of firms can, again, be considered small. 34. Cellular Licensees. The SBA has developed a small business size standard for wireless firms within the broad economic census category “Cellular and Other Wireless Telecommunications.” Under this SBA category, a wireless business is small if it has 1,500 or fewer employees. For the census category of Cellular and Other Wireless Telecommunications, Census Bureau data for 2002 show that there were 1,397 firms in this category that operated for the entire year. Of this total, 1,378 firms had employment of 999 or fewer employees, and 19 firms had employment of 1,000 employees or more. Thus, under this category and size standard, the majority of firms can be considered small. Also, according to Commission data, 437 carriers reported that they were engaged in the provision of cellular service, Personal Communications Service (PCS), or Specialized Mobile Radio
(SMR)Telephony services, which are placed together in the data. The Commission has estimated that 260 of these are small under the SBA small business size standard. 35. Paging. The SBA has developed a small business size standard for the broad economic census category of “Paging.” Under this category, the SBA deems a wireless business to be small if it has 1,500 or fewer employees. Census Bureau data for 2002 show that there were 807 firms in this category that operated for the entire year. Of this total, 804 firms had employment of 999 or fewer employees, and three firms had employment of 1,000 employees or more. In addition, according to Commission data, 365 carriers have reported that they are engaged in the provision of “Paging and Messaging Service.” Of this total, the Commission estimates that 360 have 1,500 or fewer employees, and five have more than 1,500 employees. Thus, in this category the majority of firms can be considered small. 36. We also note that, in the Paging Second Report and Order, the Commission adopted a size standard for “small businesses” for purposes of determining their eligibility for special provisions such as bidding credits and installment payments. In this context, a small business is an entity that, together with its affiliates and controlling principals, has average gross revenues not exceeding $15 million for the preceding three years. The SBA has approved this definition. An auction of Metropolitan Economic Area
(MEA)licenses commenced on February 24, 2000, and closed on March 2, 2000. Of the 2,499 licenses auctioned, 985 were sold. Fifty-seven companies claiming small business status won 440 licenses. An auction of MEA and Economic Area
(EA)licenses commenced on October 30, 2001, and closed on December 5, 2001. Of the 15,514 licenses auctioned, 5,323 were sold. One hundred thirty-two companies claiming small business status purchased 3,724 licenses. A third auction, consisting of 8,874 licenses in each of 175 EAs and 1,328 licenses in all but three of the 51 MEAs commenced on May 13, 2003, and closed on May 28, 2003. Seventy-seven bidders claiming small or very small business status won 2,093 licenses. The Commission also notes that, currently, there are approximately 74,000 Common Carrier Paging licenses. 37. Wireless Telephony. Wireless telephony includes cellular, personal communications services (PCS), and specialized mobile radio
(SMR)telephony carriers. As noted earlier, the SBA has developed a small business size standard for “Cellular and Other Wireless Telecommunications” services. Under that SBA small business size standard, a business is small if it has 1,500 or fewer employees. According to Commission data, 432 carriers reported that they were engaged in the provision of wireless telephony. The Commission has estimated that 221 of these are small under the SBA small business size standard. 38. Broadband Personal Communications Service. The broadband Personal Communications Service
(PCS)spectrum is divided into six frequency blocks designated A through F, and the Commission has held auctions for each block. The Commission defined “small entity” for Blocks C and F as an entity that has average gross revenues of $40 million or less in the three previous calendar years. For Block F, an additional classification for “very small business” was added and is defined as an entity that, together with its affiliates, has average gross revenues of not more than $15 million for the preceding three calendar years.” These standards defining “small entity” in the context of broadband PCS auctions have been approved by the SBA. No small businesses, within the SBA-approved small business size standards bid successfully for licenses in Blocks A and B. There were 90 winning bidders that qualified as small entities in the Block C auctions. A total of 93 small and very small business bidders won approximately 40 percent of the 1,479 licenses for Blocks D, E, and F. On March 23, 1999, the Commission re-auctioned 347 C, D, E, and F Block licenses. There were 48 small business winning bidders. On January 26, 2001, the Commission completed the auction of 422 C and F Broadband PCS licenses in Auction No. 35. Of the 35 winning bidders in this auction, 29 qualified as “small” or “very small” businesses. Subsequent events, concerning Auction 35, including judicial and agency determinations, resulted in a total of 163 C and F Block licenses being available for grant. 39. Narrowband Personal Communications Services. To date, two auctions of narrowband personal communications services
(PCS)licenses have been conducted. For purposes of the two auctions that have already been held, “small businesses” were entities with average gross revenues for the prior three calendar years of $40 million or less. Through these auctions, the Commission has awarded a total of 41 licenses, out of which 11 were obtained by small businesses. To ensure meaningful participation of small business entities in future auctions, the Commission has adopted a two-tiered small business size standard in the Narrowband PCS Second Report and Order. A “small business” is an entity that, together with affiliates and controlling interests, has average gross revenues for the three preceding years of not more than $40 million. A “very small business” is an entity that, together with affiliates and controlling interests, has average gross revenues for the three preceding years of not more than $15 million. The SBA has approved these small business size standards. In the future, the Commission will auction 459 licenses to serve Metropolitan Trading Areas
(MTAs)and 408 response channel licenses. There is also one megahertz of narrowband PCS spectrum that has been held in reserve and that the Commission has not yet decided to release for licensing. The Commission cannot predict accurately the number of licenses that will be awarded to small entities in future auctions. However, four of the 16 winning bidders in the two previous narrowband PCS auctions were small businesses, as that term was defined. The Commission assumes, for purposes of this analysis that a large portion of the remaining narrowband PCS licenses will be awarded to small entities. The Commission also assumes that at least some small businesses will acquire narrowband PCS licenses by means of the Commission's partitioning and disaggregation rules. 40. Rural Radiotelephone Service. The Commission has not adopted a size standard for small businesses specific to the Rural Radiotelephone Service. A significant subset of the Rural Radiotelephone Service is the Basic Exchange Telephone Radio System (BETRS). The Commission uses the SBA's small business size standard applicable to “Cellular and Other Wireless Telecommunications,” i.e., an entity employing no more than 1,500 persons. There are approximately 1,000 licensees in the Rural Radiotelephone Service, and the Commission estimates that there are 1,000 or fewer small entity licensees in the Rural Radiotelephone Service that may be affected by the rules and policies adopted herein. 41. Air-Ground Radiotelephone Service. The Commission has not adopted a small business size standard specific to the Air-Ground Radiotelephone Service. The Commission will use SBA's small business size standard applicable to “Cellular and Other Wireless Telecommunications,” i.e., an entity employing no more than 1,500 persons. There are approximately 100 licensees in the Air-Ground Radiotelephone Service, and the Commission estimates that almost all of them qualify as small under the SBA small business size standard. 42. Offshore Radiotelephone Service. This service operates on several UHF television broadcast channels that are not used for television broadcasting in the coastal areas of states bordering the Gulf of Mexico. There are presently approximately 55 licensees in this service. The Commission is unable to estimate at this time the number of licensees that would qualify as small under the SBA's small business size standard for “Cellular and Other Wireless Telecommunications” services. Under that SBA small business size standard, a business is small if it has 1,500 or fewer employees. 2. Cable and OVS Operators 43. Cable Television Distribution Services. Since 2007, these services have been defined within the broad economic census category of Wired Telecommunications Carriers; that category is defined as follows: “This industry comprises establishments primarily engaged in operating and/or providing access to transmission facilities and infrastructure that they own and/or lease for the transmission of voice, data, text, sound, and video using wired telecommunications networks. Transmission facilities may be based on a single technology or a combination of technologies.” The SBA has developed a small business size standard for this category, which is: all such firms having 1,500 or fewer employees. To gauge small business prevalence for these cable services the Commission must, however, use current census data that are based on the previous category of Cable and Other Program Distribution and its associated size standard; that size standard was: all such firms having $13.5 million or less in annual receipts. According to Census Bureau data for 2002, there were a total of 1,191 firms in this previous category that operated for the entire year. Of this total, 1,087 firms had annual receipts of under $10 million, and 43 firms had receipts of $10 million or more but less than $25 million. Thus, the majority of these firms can be considered small. 44. Cable Companies and Systems. The Commission has also developed its own small business size standards, for the purpose of cable rate regulation. Under the Commission's rules, a “small cable company” is one serving 400,000 or fewer subscribers, nationwide. Industry data indicate that, of 1,076 cable operators nationwide, all but eleven are small under this size standard. In addition, under the Commission's rules, a “small system” is a cable system serving 15,000 or fewer subscribers. Industry data indicate that, of 7,208 systems nationwide, 6,139 systems have under 10,000 subscribers, and an additional 379 systems have 10,000-19,999 subscribers. Thus, under this second size standard, most cable systems are small. 45. Cable System Operators. The Communications Act of 1934, as amended, also contains a size standard for small cable system operators, which is “a cable operator that, directly or through an affiliate, serves in the aggregate fewer than 1 percent of all subscribers in the United States and is not affiliated with any entity or entities whose gross annual revenues in the aggregate exceed $250,000,000.” The Commission has determined that an operator serving fewer than 677,000 subscribers shall be deemed a small operator, if its annual revenues, when combined with the total annual revenues of all its affiliates, do not exceed $250 million in the aggregate. Industry data indicate that, of 1,076 cable operators nationwide, all but ten are small under this size standard. The Commission neither requests nor collects information on whether cable system operators are affiliated with entities whose gross annual revenues exceed $250 million, and therefore the Commission is unable to estimate more accurately the number of cable system operators that would qualify as small under this size standard. 46. Open Video Systems (OVS). In 1996, Congress established the open video system
(OVS)framework, one of four statutorily recognized options for the provision of video programming services by local exchange carriers (LECs). The OVS framework provides opportunities for the distribution of video programming other than through cable systems. Because OVS operators provide subscription services, OVS falls within the SBA small business size standard of Cable and Other Program Distribution Services, which consists of such entities having $13.5 million or less in annual receipts. The Commission has certified 25 OVS operators, with some now providing service. Broadband service providers
(BSPs)are currently the only significant holders of OVS certifications or local OVS franchises. As of June 2005, BSPs served approximately 1.4 million subscribers, representing 1.5 percent of all MVPD households. Affiliates of Residential Communications Network, Inc. (RCN), which serves about 371,000 subscribers as of June 2005, is currently the largest BSP and 14th largest MVPD. RCN received approval to operate OVS systems in New York City, Boston, Washington, DC and other areas. The Commission does not have financial information regarding the entities authorized to provide OVS, some of which may not yet be operational. The Commission thus believes that at least some of the OVS operators may qualify as small entities. 3. Internet Service Providers 47. Internet Service Providers. The SBA has developed a small business size standard for Internet Service Providers (ISPs). ISPs “provide clients access to the Internet and generally provide related services such as web hosting, web page designing, and hardware or software consulting related to Internet connectivity.” Under the SBA size standard, such a business is small if it has average annual receipts of $23 million or less. According to Census Bureau data for 2002, there were 2,529 firms in this category that operated for the entire year. Of these, 2,437 firms had annual receipts of under $10 million, and an additional 47 firms had receipts of between $10 million and $24,999,999. Consequently, the Commission estimates that the majority of these firms are small entities that may be affected by Commission action. 48. All Other Information Services. “This industry comprises establishments primarily engaged in providing other information services (except new syndicates and libraries and archives).” The SBA has developed a small business size standard for this category; that size standard is $6.5 million or less in average annual receipts. According to Census Bureau data for 2002, there were 155 firms in this category that operated for the entire year. Of these, 138 had annual receipts of under $5 million, and an additional four firms had receipts of between $5 million and $9,999,999. Consequently, the Commission estimates that the majority of these firms are small entities that may be affected by its action. 4. Public Utilities 49. Electric Power Generation, Transmission and Distribution. The Census Bureau defines this category as follows: “This industry group comprises establishments primarily engaged in generating, transmitting, and/or distributing electric power. Establishments in this industry group may perform one or more of the following activities:
(1)Operate generation facilities that produce electric energy;
(2)operate transmission systems that convey the electricity from the generation facility to the distribution system; and
(3)operate distribution systems that convey electric power received from the generation facility or the transmission system to the final consumer.” This category includes Electric Power Distribution, Hydroelectric Power Generation, Fossil Fuel Power Generation, Nuclear Electric Power Generation, and Other Electric Power Generation. The SBA has developed a small business size standard for firms in this category: “A firm is small if, including its affiliates, it is primarily engaged in the generation, transmission, and/or distribution of electric energy for sale and its total electric output for the preceding fiscal year did not exceed 4 million megawatt hours.” According to Census Bureau data for 2002, there were 1,644 firms in this category that operated for the entire year. Census data do not track electric output and the Commission has not determined how many of these firms fit the SBA size standard for small, with no more than 4 million megawatt hours of electric output. Consequently, the Commission estimates that 1,644 or fewer firms may be considered small under the SBA small business size standard. 50. Natural Gas Distribution. This economic census category comprises: “(1) Establishments primarily engaged in operating gas distribution systems (e.g., mains, meters);
(2)establishments known as gas marketers that buy gas from the well and sell it to a distribution system;
(3)establishments known as gas brokers or agents that arrange the sale of gas over gas distribution systems operated by others; and
(4)establishments primarily engaged in transmitting and distributing gas to final consumers.” The SBA has developed a small business size standard for this industry, which is: All such firms having 500 or fewer employees. According to Census Bureau data for 2002, there were 468 firms in this category that operated for the entire year. Of this total, 424 firms had employment of fewer than 500 employees, and 18 firms had employment of 500 to 999 employees. Thus, the majority of firms in this category can be considered small. 51. Water Supply and Irrigation Systems. This economic census category “comprises establishments primarily engaged in operating water treatment plants and/or operating water supply systems.” The SBA has developed a small business size standard for this industry, which is: All such firms having $6.5 million or less in annual receipts. According to Census Bureau data for 2002, there were 3,830 firms in this category that operated for the entire year. Of this total, 3,757 firms had annual sales of less than $5 million, and 37 firms had sales of $5 million or more but less than $10 million. Thus, the majority of firms in this category can be considered small. D. Description of Projected Reporting, Recordkeeping and Other Compliance Requirements 52. Should the Commission alter the pole attachment rate structure, such action could result in increased, reduced, or otherwise altered reporting, recordkeeping or other compliance requirements for pole owners and attaching entities. For example, if the Commission were to adopt a uniform rate for all pole attachments used for broadband Internet access service, providers of such services might be required to record and report where such service is offered. If the Commission were to adopt a uniform rate for all pole attachments, such action could eliminate the need for cable television systems to record and report to utilities where they or their lessees offer telecommunications services. Changes to reporting, recordkeeping or other compliance requirements could either be new (e.g., if telecommunications carriers begin to record or report where they offer broadband Internet access service) or could reconfigure existing requirements (e.g., if cable television systems begin to record and report where they or their lessees offer broadband Internet access service, but cease to record and report where they or their lessees offer telecommunications services). If the Commission initiates regulation of the rates, terms, and conditions of pole attachment by incumbent LECs, such regulation could increase reporting, recordkeeping or other compliance requirements for pole owners and incumbent LECs where incumbent LECs attach to poles owned by other utilities. 53. Should the Commission adopt regulations concerning access to poles, ducts, conduits, and rights-of-way, such action could result in increased, reduced, or otherwise altered reporting, recordkeeping or other compliance requirements for pole owners, attaching entities, and users of ducts, conduits, and rights-of-way. In particular, if the Commission adopts rules governing specific techniques for pole and conduit modification, as opposed to resolution on a case-specific complaint basis, reporting, recordkeeping or other compliance requirements could change. Examples of specific topics where recordkeeping, reporting, or compliance requirements could change by virtue of Commission action include:
(1)Searches and surveys of both poles and conduit, including information management;
(2)performance of make-ready work, including timeliness, safety, capacity, and the use of boxing and extension arms;
(3)the use of qualified third-party contract workers;
(4)access to in-building ducts, conduit, and rights-of-way, including access to incumbent LEC central offices; or
(5)practices relating to drop lines and poles. E. Steps Taken To Minimize Significant Economic Impact on Small Entities, and Significant Alternatives Considered 54. The RFA requires an agency to describe any significant alternatives that it has considered in reaching its proposed approach, which may include (among others) the following four alternatives:
(1)The establishment of differing compliance or reporting requirements or timetables that take into account the resources available to small entities;
(2)the clarification, consolidation, or simplification of compliance or reporting requirements under the rule for small entities;
(3)the use of performance, rather than design, standards; and
(4)an exemption from coverage of the rule, or any part thereof, for small entities. 55. The Commission tentatively concludes that it will promote broadband deployment and technological neutrality by requiring all categories of companies to pay the same pole attachment rate for all pole attachments used for broadband Internet access service, and the *NPRM* seeks comment on the possible economic effect on small entities of adopting this requirement. In coming to this tentative conclusion, the Commission first assessed the alternative of continuing a system of two rates. Another objective is to implement overarching policies concerning safety, certainty, administrability, and nondiscrimination. When alternatives are discussed, such as whether it would be better to choose an existing rate as the broadband Internet access services rate (and, if so, which rate) or to modify existing rates, the *NPRM* invites small entities to discuss the economic ramifications of such action. The *NPRM* seeks comment on whether regulation of pole attachment rates is particularly necessary for small incumbent LECs, and asks how incumbent LECs could be affected if rates and terms were regulated absent a right of access. The *NPRM* also seeks comment on the general usefulness of rules, presumptions, or guidelines, as opposed to case-specific adjudication, and how these alternative approaches to resolving access issues may affect small entities. F. Federal Rules That May Duplicate, Overlap, or Conflict With the Proposed Rules 56. None. Since the enactment of the 1996 Act, the Commission has encouraged disputing parties to participate in staff-supervised, pre-complaint mediation. Such mediation has proven to be very successful, including in pole attachment disputes. Certain rules regarding pole attachment complaints, however, may have had the unintended consequence of discouraging pre-complaint mediation. Thus, the Commission seeks comment on whether those rules should be amended or eliminated to facilitate mediation of disputes. In addition, under current Commission rules, an attacher may execute a pole attachment agreement with a utility, and then later file a complaint challenging the lawfulness of a provision of that agreement. The Commission seeks comment on whether it should adopt some contours to the rule, such as time-frames for raising written concerns about a provision of a pole attachment agreement. Ordering Clauses 57. Accordingly, *it is ordered* that pursuant to sections 1, 4(i), 4(j), 224, 303 and 403 of the Communications Act of 1934, as amended, 47 U.S.C. 151, 154(i)-(j), 224, 303, 403, this Notice of Proposed Rulemaking in WC Docket No. 07-245 *is adopted* . 58. *It is further ordered* that the Fibertech Networks, LLC, Petition for Rulemaking, RM-11303, and the United States Telecom Association Petition for Rulemaking, RM-11293, *are granted* to the extent indicated herein and otherwise *are denied* . 59. *It is further ordered* that the Commission's Consumer and Governmental Affairs Bureau, Reference Information Center, *shall send* a copy of this *NPRM* , including the Initial Regulatory Flexibility Analysis, to the Chief Counsel for Advocacy of the Small Business Administration. Federal Communications Commission. Marlene H. Dortch, Secretary. [FR Doc. E8-2177 Filed 2-5-08; 8:45 am] BILLING CODE 6712-01-P FEDERAL COMMUNICATIONS COMMISSION 47 CFR Part 1 [WC Docket No. 07-267; FCC 07-202] Petition To Establish Procedural Requirements To Govern Proceedings for Forbearance Under Section 10 of the Communications Act of 1934, as Amended AGENCY: Federal Communications Commission. ACTION: Proposed rule. SUMMARY: In this document, the Commission seeks comment regarding whether to adopt procedural rules to govern the Commission's consideration of petitions to forbear from enforcing rules that are alleged to be unnecessary or inconsistent with the public interest (forbearance petitions). The Commission is responding to arguments that current procedures governing consideration of forbearance petitions are unfair, and to several proposed new rules that would include, for example, requiring forbearance petitions to be complete-as-filed, and assigning the burden of proof on parties that file forbearance petitions. The Commission intends both to solicit comment on the proposals before it and to encourage suggestions of other rules that the Commission should consider that would govern the form and content of forbearance petitions. DATES: Comments are due March 7, 2008 and Reply Comments are due March 24, 2008. Written comments on the Paperwork Reduction Act proposed information collection requirements must be submitted by the public, Office of Management and Budget (OMB), and other interested parties on or before April 7, 2008. ADDRESSES: You may submit comments, identified by WC Docket No. 07-267, by any of the following methods: • *Federal eRulemaking Portal:* *http://www.regulations.gov* . Follow the instructions for submitting comments. • *Federal Communications Commission's Web Site:* *http://www.fcc.gov/cgb/ecfs/* . Follow the instructions for submitting comments. • *E-mail:* *ecfs@fcc.gov* , and include the following words in the body of the message, “get form.” A sample form and directions will be sent in response. Include the docket number in the subject line of the message. • *Mail:* Secretary, Federal Communications Commission, 445 12th Street, SW., Washington, DC 20554. • People with Disabilities: Contact the FCC to request reasonable accommodations (accessible format documents, sign language interpreters, CART, etc.) by e-mail: *FCC504@fcc.gov* or phone: 202-418-0530 or TTY: 202-418-0432. For detailed instructions for submitting comments and additional information on the rulemaking process, see the SUPPLEMENTARY INFORMATION section of this document. In addition to filing comments with the Secretary, a copy of any comments on the Paperwork Reduction Act information collection requirements contained herein should be submitted to the Federal Communications Commission via e-mail to *PRA@fcc.gov* and to Nicholas A. Fraser, Office of Management and Budget, via e-mail to *Nicholas_A._Fraser@omb.eop.gov* or via fax at 202-395-5167. FOR FURTHER INFORMATION CONTACT: Jonathan Reel, Wireline Competition Bureau,
(202)418-1580. For additional information concerning the Paperwork Reduction Act information collection requirements contained in this document, contact Jerry R. Cowden at
(202)418-0447, or via the Internet at *PRA@fcc.gov* . SUPPLEMENTARY INFORMATION: Pursuant to §§ 1.415 and 1.419 of the Commission's rules, 47 CFR 1.415, 1.419, interested parties may file Comments on or before March 7, 2008 and Reply Comments on or before March 24, 2008. Comments may be filed using:
(1)The Commission's Electronic Comment Filing System (ECFS),
(2)the Federal Government's eRulemaking Portal, or
(3)by filing paper copies. *See Electronic Filing of Documents in Rulemaking Proceedings,* 63 FR 24121, May 1, 1998. • *Electronic Filers:* Comments may be filed electronically using the Internet by accessing the ECFS: *http://www.fcc.gov/cgb/ecfs/* or the Federal eRulemaking Portal: *http://www.regulations.gov* . Filers should follow the instructions provided on the Web site for submitting comments. • For ECFS filers, if multiple docket or rulemaking numbers appear in the caption of this proceeding, filers must transmit one electronic copy of the comments for each docket or rulemaking number referenced in the caption. In completing the transmittal screen, filers should include their full name, U.S. Postal Service mailing address, and the applicable docket or rulemaking number. Parties may also submit an electronic comment by Internet e-mail. To get filing instructions, filers should send an e-mail to *ecfs@fcc.gov* , and include the following words in the body of the message, “get form.” A sample form and directions will be sent in response. • *Paper Filers:* Parties who choose to file by paper must file an original and four copies of each filing. If more than one docket or rulemaking number appears in the caption of this proceeding, filers must submit two additional copies for each additional docket or rulemaking number. Filings can be sent by hand or messenger delivery, by commercial overnight courier, or by first-class or overnight U.S. Postal Service mail (although we continue to experience delays in receiving U.S. Postal Service mail). All filings must be addressed to the Commission's Secretary, Office of the Secretary, Federal Communications Commission. • The Commission's contractor will receive hand-delivered or messenger-delivered paper filings for the Commission's Secretary at 236 Massachusetts Avenue, NE., Suite 110, Washington, DC 20002. The filing hours at this location are 8 a.m. to 7 p.m. All hand deliveries must be held together with rubber bands or fasteners. Any envelopes must be disposed of *before* entering the building. • Commercial overnight mail (other than U.S. Postal Service Express Mail and Priority Mail) must be sent to 9300 East Hampton Drive, Capitol Heights, MD 20743. • U.S. Postal Service first-class, Express, and Priority mail must be addressed to 445 12th Street, SW., Washington, DC 20554. *People with Disabilities:* To request materials in accessible formats for people with disabilities (braille, large print, electronic files, audio format), send an e-mail to *fcc504@fcc.gov* or call the Consumer & Governmental Affairs Bureau at 202-418-0530 (voice), 202-418-0432 (tty). ADDRESSES: You may submit comments, identified by WC Docket No. 07-267, by any of the following methods: • *Federal eRulemaking Portal:* *http://www.regulations.gov* . Follow the instructions for submitting comments. • *Federal Communications Commission's Web Site:* *http://www.fcc.gov/cgb/ecfs/* . Follow the instructions for submitting comments. • *E-mail:* *ecfs@fcc.gov* , and include the following words in the body of the message, “get form.” A sample form and directions will be sent in response. Include the docket number in the subject line of the message. • *Mail:* Secretary, Federal Communications Commission, 445 12th Street, SW., Washington, DC 20554. • *People with Disabilities:* Contact the FCC to request reasonable accommodations (accessible format documents, sign language interpreters, CART, etc.) by e-mail: *FCC504@fcc.gov* or phone: 202-418-0530 or TTY: 202-418-0432. For detailed instructions for submitting comments and additional information on the rulemaking process, see the SUPPLEMENTARY INFORMATION section of this document. Initial Paperwork Reduction Act of 1995 Analysis This document does not contain proposed information collection requirements subject to the Paperwork Reduction Act of 1995, Public Law 104-13. In addition, therefore, it does not contain any proposed information collection burden “for small business concerns with fewer than 25 employees,” pursuant to the Small Business Paperwork Relief Act of 2002, Public Law 107-198, see 44 U.S.C. 3506(c)(4). Synopsis of the Notice of Proposed Rulemaking Petition To Establish Procedural Requirements To Govern Proceedings for Forbearance Under Section 10 of the Communications Act of 1934, as Amended 1. In this Notice of Proposed Rulemaking ( *NPRM* ), the Commission addresses the Petition filed on September 19, 2007 by Covad Communications Group, NuVox Communications, XO Communications, LLC, Cavalier Telephone Corp., and McLeod USA Telecommunications Services, Inc. (Petitioners or Covad, *et al.* ) asking the Commission to consider the adoption of procedural rules to govern the Commission's consideration of petitions for forbearance pursuant to the Communications Act of 1934, as amended (Act). 2. Pursuant to section 10 of the Act, the Commission is required to forbear from any statutory provision or regulation if it determines that:
(1)Enforcement of the regulation is not necessary to ensure that the telecommunications carrier's charges, practices, classifications, or regulations are just, reasonable, and not unjustly or unreasonably discriminatory;
(2)enforcement of the regulation is not necessary to protect consumers; and
(3)forbearance from applying such provision or regulation is consistent with the public interest. In determining whether forbearance is consistent with the public interest, the Commission also must consider whether forbearance from enforcing the provision or regulation will promote competitive market conditions. In addition, section 332(c)(1)(A) of the Act authorizes the Commission to “forbear” from applying the provisions of Title II to commercial mobile radio service
(CMRS)providers, except for sections 201, 202, and 208, if certain criteria are satisfied. In particular, the Commission may exercise its forbearance authority pursuant to section 332 if it determines that:
(1)Enforcement of the requirement is unnecessary to ensure that rates are just, reasonable, and non-discriminatory;
(2)the requirement is not needed to protect consumers; and
(3)forbearance is consistent with the public interest. The Commission also must consider whether any proposed forbearance from the requirements of Title II will enhance competition among CMRS providers. 3. The Commission seeks comment in general on the need for procedural rules to govern the Commission's consideration of petitions for forbearance pursuant to section 10 and/or section 332 (collectively, forbearance petitions), and with respect to the issues raised and rules proposed by the Petitioners in particular. For example, the Petitioners cite the need to apply Administrative Procedure Act
(APA)notice-and-comment rules to forbearance petitions. The Petitioners state that to date the Commission's practice has been to provide interested parties with the opportunity to comment on a forbearance petition. Petitioners argue, however, that the Commission should institutionalize this practice to ensure that potentially-affected parties have a well-defined right to have their views taken into account. The Commission seeks comment both on the Petitioners' specific proposal and, more generally, on how the Commission should provide notice and an opportunity to comment in forbearance proceedings. 4. The Petitioners also request the adoption of rules governing the format and content of forbearance petitions, including a complete-as-filed requirement. In particular, the Petitioners contend that a complete-as-filed rule would facilitate Commission review and would help ensure that all interested parties have a full and fair opportunity to present their views to the Commission. The Petitioners note that the Commission has adopted similar requirements in other circumstances, such as section 271 proceedings and formal complaint proceedings subject to statutory deadlines. The Commission seeks comment on the Petitioners' specific proposal for complete-as-filed requirements, including whether the Commission should specify certain information necessary for a *prima facie* showing that forbearance is warranted as the Petitioners recommend. The Commission also seeks comment on the Petitioners' proposal for a rule specifying that the forbearance petitioner has the burden of proof. The Commission also seeks comment on whether there are other particular rules governing the form and content of forbearance petitions that the Commission should consider. 5. In addition, the Petitioners propose that the Commission require a forbearance petitioner to separately demonstrate how it has satisfied each component of the forbearance standard. They assert that such a requirement is consistent with the Commission's pleading requirements in other contexts. The Petitioners contend that, in past practice, petitioners have failed to address each element of the section 10 standard individually, instead generally asserting that the forbearance criteria are satisfied with respect to all of the regulations and statutory provisions from which they are seeking forbearance. The Commission seeks comment on the Petitioners' specific proposal, including its relationship to the section 10 or section 332 forbearance standard and the Commission's forbearance analysis set forth in prior orders. 6. The Commission also seeks comment on the Petitioners' request that the Commission adopt particular rules addressing the scope and interpretation of protective orders in forbearance proceedings. The Petitioners suggest rules governing the timing of adoption of protective orders and the terms of access to, and use of, documents and information submitted pursuant to those protective orders. For example, the Petitioners suggest that all interested parties should be permitted to obtain copies of confidential and highly confidential documents. In addition, the Petitioners recommend that parties be allowed to use information submitted pursuant to protective order in one forbearance proceeding in other Commission forbearance proceedings in which a petitioning party seeks relief from the same rules and/or statutory provisions and that states be permitted to use documents designated as Confidential and Highly Confidential in related state proceedings. The Commission seeks comment on the Petitioners' specific proposals, as well as any other comments regarding the submission of, access to, and use of documents and information covered by protective orders in forbearance proceedings. The Commission also seeks comment specifically on the relationship between the rules proposed by Petitioners or other commenters and the Commission's rules and precedent regarding information withheld from public inspection. 7. The Petitioners further seek rules establishing a timetable for Commission proceedings addressing forbearance petitions, which, among other things, incorporates a limited period for a petitioning party to cure minor defects in its petition without having to re-start the statutory clock, provides a specific vehicle for state commission input in the forbearance process; addresses motions to dismiss, and establishes a standard comment cycle; as well as a time limit on substantive ex parte submissions and other requirements. The Commission seeks comment on each of the proposals suggested by the Petitioners, as well as their general recommendation for the adoption of specific timetables for the Commission's review of forbearance petitions. The Commission also seeks comment on other proposals for steps the Commission could take to facilitate the participation of state commissions, as well as other parties, in forbearance proceedings. 8. The Petitioners propose that the Commission adopt additional requirements for petitions seeking forbearance from sections 251 and/or 271 of the Act. For example, the Petitioners propose that petitioners seeking forbearance from sections 251 or 271 must provide supporting data at the wire center level. The Petitioners further propose that the Commission adopt a rule inviting states to report to the Commission on the potential effects of sections 251 and/or 271 forbearance in their states. 9. The Petitioners also suggest certain procedural requirements governing the resolution of forbearance petitions, including a proposal that the Commission adopt a rule requiring the issuance of a written order on all forbearance petitions, including those petitions that previously have been “deemed granted.” The Commission seeks comment on that proposal. 10. To the extent that the Commission adopts procedural rules to govern forbearance petitions, the Petitioners request that those rules apply both to forbearance petitions filed in the future, as the well as forbearance petitions already pending before the Commission. The Commission seeks comment on the extent of the Commission's authority to adopt procedural rules governing both future forbearance petitions as well as those that already are pending before the Commission, particularly with respect to the procedural rules proposed by the Petitioners. The Commission also seeks comment on the propriety, as a policy matter, of extending particular procedural rules in such manner. 11. In recent years, the Commission has witnessed a significant increase in the number of petitions seeking forbearance submitted by telecommunications carriers that the Commission oversees. These petitions have had different results, such as petitions being approved, denied, withdrawn or deemed granted. In the course of Congressional oversight, some Members of Congress have raised concerns with how forbearance is used. Some companies have indicated serious concerns with the forbearance process, while others argue that it is an important tool for the Commission to eliminate rules, consistent with the public interest. The Commission therefore seeks comment on whether forbearance is an effective means for the Commission to make changes to its regulations. The Commission also seeks comment on whether forbearance is being utilized for the purposes intended by Congress. The Commission asks whether there are unintended consequences of forbearance, such as a focus on these petitions at the expense of other industry-wide proceedings, including burdens on stakeholders from forbearance proceedings, such as administrative and financial costs. The Commission asks whether there are additional burdens placed on stakeholders due to the fact that there is a statutory deadline on the completion of forbearance petitions. The Commission also seeks comment regarding the effects of having a company-specific petition drive agency decisions, rather than the Commission deciding to take industry-wide actions. 12. Finally, the Commission seeks comment on any other aspects of the Petition, as well as any other comments regarding the need for any other procedural rules to govern the Commission's consideration of forbearance petitions. The Commission also invites comment on the possible effect on small entities from adopting any of the Petitioners' proposed rules, or variations of those proposals set forth above. To the extent that the Commission were to adopt any procedural rules governing forbearance petitions proposed by the Petitioners or otherwise justified in the record, the Commission asks what would be the appropriate remedy for a violation of those rules. Ex Parte Presentations 13. The rulemaking this *NPRM* initiates shall be treated as a “permit-but-disclose” proceeding in accordance with the Commission's ex parte rules. Persons making oral ex parte presentations are reminded that memoranda summarizing the presentations must contain summaries of the substance of the presentations and not merely a listing of the subjects discussed. More than a one or two sentence description of the views and arguments presented generally is required. Other requirements pertaining to oral and written presentations are set forth in § 1.1206(b) of the Commission's rules. Initial Regulatory Flexibility Analysis 14. As required by the Regulatory Flexibility Act of 1980, the Commission has prepared an Initial Regulatory Flexibility Analysis
(IRFA)of the possible significant economic impact on small entities of the policies and rules addressed in this document. The IRFA is set forth separately below. Written public comments are requested on this IRFA. Comments must be identified as responses to the IRFA. Comments are due March 7, 2008 and Reply Comments are due March 24, 2008. Paperwork Reduction Act 15. This document contains proposed new or modified information collection requirements. The Commission, as part of its continuing effort to reduce paperwork burdens, invites the general public and the Office of Management and Budget
(OMB)to comment on the information collection requirements contained in this document, as required by the Paperwork Reduction Act of 1995, Public Law 104-13. In addition, pursuant to the Small Business Paperwork Relief Act of 2002, Public Law 107-198, see 44 U.S.C. 3506(c)(4), we seek specific comment on how we might “further reduce the information collection burden for small business concerns with fewer than 25 employees.” Accessible Formats 16. To request materials in accessible formats for people with disabilities (Braille, large print, electronic files, audio format), send an e-mail to *fcc504@fcc.gov* or call the Consumer & Governmental Affairs Bureau at 202-418-0530 (voice) or 202-418-0432 (TTY). Contact the FCC to request reasonable accommodations for filing comments (accessible format documents, sign language interpreters, CART, etc.) by e-mail: *FCC504@fcc.gov* ; phone: 202-418-0530 or TTY: 202-418-0432. Initial Regulatory Flexibility Analysis 17. As required by the Regulatory Flexibility Act of 1980, as amended (RFA), the Commission has prepared the present Initial Regulatory Flexibility Analysis
(IRFA)of the possible significant economic impact on small entities that might result from this *NPRM* . Written public comments are requested on this IRFA. Comments must be identified as responses to the IRFA and must be filed by the deadlines for comments on the *NPRM* provided above. The Commission will send a copy of the *NPRM* , including this IRFA, to the Chief Counsel for Advocacy of the Small Business Administration. In addition, the *NPRM* and the IRFA (or summaries thereof) will be published in the **Federal Register** . A. Need For, and Objectives Of, the Proposed Rules 18. In this *NPRM* , we seek comment on whether the Commission should adopt procedural rules governing its consideration of petitions for forbearance pursuant to section 10 or section 332 of the Act. In particular, we seek comment on the need to apply APA notice-and-comment rules to forbearance petitions. We also seek comment on the burdens of proof and production in forbearance proceedings. Additionally, we seek comment on whether to adopt rules governing the form and content of forbearance petitions, including possibly a “complete-as-filed” requirement and a requirement that the petitioner demonstrate that it has satisfied each element of the forbearance standard. Further, we solicit comment on the need for rules governing the scope and interpretation of protective orders in forbearance proceedings. In addition, we seek comment on the need for rules establishing timetables for Commission proceedings addressing forbearance petitions. In the *NPRM* , we also seek comment on whether additional rules are warranted for petitions seeking forbearance from section 251 or section 271 of the Act. We further seek comment on whether we should adopt procedural requirements governing the resolution of forbearance petitions. We also seek comment on the need for any other procedural rules governing forbearance petitions, the scope of application of such rules, and the appropriate remedies for violation should the Commission adopt such rules. For each of these issues, we seek comment on the possible effects on small entities, associated with any rules the Commission might adopt. B. Legal Basis 19. The legal basis for any action that may be taken pursuant to this NPRM is contained in sections 1, 4(i), 4(j), 10, 303, 332 and 403 of the Communications Act of 1934, as amended, 47 U.S.C. 151, 154(i)-(j), 160, 303, 332, 403. C. Description and Estimate of the Number of Small Entities To Which the Proposed Rules May Apply 20. The RFA directs agencies to provide a description of, and where feasible, an estimate of the number of small entities that may be affected by the proposed rules and policies, if adopted. The RFA generally defines the term “small entity” as having the same meaning as the terms “small business,” “small organization,” and “small governmental jurisdiction.” In addition, the term “small business” has the same meaning as the term “small business concern” under the Small Business Act. A “small business concern” is one which:
(1)Is independently owned and operated;
(2)is not dominant in its field of operation; and
(3)satisfies any additional criteria established by the SBA. 21. Small Businesses. Nationwide, there are a total of 22.4 million small businesses, according to SBA data. 22. Small Organizations. Nationwide, there are approximately 1.6 million small organizations. 23. Small Governmental Jurisdictions. The term “small governmental jurisdiction” is defined generally as “governments of cities, towns, townships, villages, school districts, or special districts, with a population of less than fifty thousand.” Census Bureau data for 2002 indicate that there were 87,525 local governmental jurisdictions in the United States. We estimate that, of this total, 84,377 entities were “small governmental jurisdictions.” Thus, we estimate that most governmental jurisdictions are small. 24. Incumbent Local Exchange Carriers (ILECs). Neither the Commission nor the SBA has developed a small business size standard specifically for incumbent local exchange services. The appropriate size standard under SBA rules is for the category Wired Telecommunications Carriers. Under that size standard, such a business is small if it has 1,500 or fewer employees. According to Commission data, 1,303 carriers have reported that they are engaged in the provision of incumbent local exchange services. Of these 1,303 carriers, an estimated 1,020 have 1,500 or fewer employees and 283 have more than 1,500 employees. Consequently, the Commission estimates that most providers of incumbent local exchange service are small businesses that may be affected by our proposed action. 25. Competitive Local Exchange Carriers (CLECs), Competitive Access Providers (CAPs), “Shared-Tenant Service Providers,” and “Other Local Service Providers.” Neither the Commission nor the SBA has developed a small business size standard specifically for these service providers. The appropriate size standard under SBA rules is for the category Wired Telecommunications Carriers. Under that size standard, such a business is small if it has 1,500 or fewer employees. According to Commission data, 769 carriers have reported that they are engaged in the provision of either competitive access provider services or competitive local exchange carrier services. Of these 769 carriers, an estimated 676 have 1,500 or fewer employees and 94 have more than 1,500 employees. In addition, 12 carriers have reported that they are “Shared-Tenant Service Providers,” and all 12 are estimated to have 1,500 or fewer employees. In addition, 39 carriers have reported that they are “Other Local Service Providers.” Of the 39, an estimated 38 have 1,500 or fewer employees and one has more than 1,500 employees. Consequently, the Commission estimates that most providers of competitive local exchange service, competitive access providers, “Shared-Tenant Service Providers,” and “Other Local Service Providers” are small entities that may be affected by our proposed action. 26. Interexchange Carriers (IXCs). Neither the Commission nor the SBA has developed a small business size standard specifically for providers of interexchange services. The appropriate size standard under SBA rules is for the category Wired Telecommunications Carriers. Under that size standard, such a business is small if it has 1,500 or fewer employees. According to Commission data, 316 carriers have reported that they are engaged in the provision of interexchange service. Of these, an estimated 292 have 1,500 or fewer employees and 24 have more than 1,500 employees. Consequently, the Commission estimates that the majority of IXCs are small entities that may be affected by our proposed action. 27. International Service Providers. There is no small business size standard developed specifically for providers of international service. The appropriate size standards under SBA rules are for the two broad census categories of “Satellite Telecommunications” and “Other Telecommunications.” Under both categories, such a business is small if it has $13.5 million or less in average annual receipts. 28. The first category of Satellite Telecommunications “comprises establishments primarily engaged in providing point-to-point telecommunications services to other establishments in the telecommunications and broadcasting industries by forwarding and receiving communications signals via a system of satellites or reselling satellite telecommunications.” For this category, Census Bureau data for 2002 show that there were a total of 371 firms that operated for the entire year. Of this total, 307 firms had annual receipts of under $10 million, and 26 firms had receipts of $10 million to $24,999,999. Consequently, we estimate that the majority of Satellite Telecommunications firms are small entities that might be affected by our action. 29. The second category of Other Telecommunications “comprises establishments primarily engaged in
(1)providing specialized telecommunications applications, such as satellite tracking, communications telemetry, and radar station operations; or
(2)providing satellite terminal stations and associated facilities operationally connected with one or more terrestrial communications systems and capable of transmitting telecommunications to or receiving telecommunications from satellite systems.” For this category, Census Bureau data for 2002 show that there were a total of 332 firms that operated for the entire year. Of this total, 259 firms had annual receipts of under $10 million and 15 firms had annual receipts of $10 million to $24,999,999. Consequently, we estimate that the majority of Other Telecommunications firms are small entities that might be affected by our action. 30. Wireless Service Providers. The SBA has developed a small business size standard for wireless firms within the two broad economic census categories of “Paging” and “Cellular and Other Wireless Telecommunications.” Under both categories, the SBA deems a wireless business to be small if it has 1,500 or fewer employees. For the census category of Paging, Census Bureau data for 2002 show that there were 807 firms in this category that operated for the entire year. Of this total, 804 firms had employment of 999 or fewer employees, and three firms had employment of 1,000 employees or more. Thus, under this category and associated small business size standard, the majority of firms can be considered small. For the census category of Cellular and Other Wireless Telecommunications, Census Bureau data for 2002 show that there were 1,397 firms in this category that operated for the entire year. Of this total, 1,378 firms had employment of 999 or fewer employees, and 19 firms had employment of 1,000 employees or more. Thus, under this second category and size standard, the majority of firms can, again, be considered small. 31. Cellular Licensees. The SBA has developed a small business size standard for wireless firms within the two broad economic census categories of “Paging” and “Cellular and Other Wireless Telecommunications.” Under both categories, the SBA deems a wireless business to be small if it has 1,500 or fewer employees. For the census category of Paging, Census Bureau data for 2002 show that there were 807 firms in this category that operated for the entire year. Of this total, 804 firms had employment of 999 or fewer employees, and three firms had employment of 1,000 employees or more. Thus, under this category and associated small business size standard, the majority of firms can be considered small. For the census category of Cellular and Other Wireless Telecommunications, Census Bureau data for 2002 show that there were 1,397 firms in this category that operated for the entire year. Of this total, 1,378 firms had employment of 999 or fewer employees, and 19 firms had employment of 1,000 employees or more. Thus, under this second category and size standard, the majority of firms can, again, be considered small. 32. Common Carrier Paging. As noted, the SBA has developed a small business size standard for wireless firms within the broad economic census categories of “Cellular and Other Wireless Telecommunications.” Under this SBA category, a wireless business is small if it has 1,500 or fewer employees. For the census category of Paging, U.S. Census Bureau data for 1997 show that there were 1,320 firms in this category, total, that operated for the entire year. Of this total, 1,303 firms had employment of 999 or fewer employees, and an additional 17 firms had employment of 1,000 employees or more. Thus, under this category and associated small business size standard, the great majority of firms can be considered small. 33. In addition, in the Paging Second Report and Order, the Commission adopted a size standard for “small businesses” for purposes of determining their eligibility for special provisions such as bidding credits and installment payments. A small business is an entity that, together with its affiliates and controlling principals, has average gross revenues not exceeding $15 million for the preceding three years. The SBA has approved this definition. An auction of Metropolitan Economic Area
(MEA)licenses commenced on February 24, 2000, and closed on March 2, 2000. Of the 2,499 licenses auctioned, 985 were sold. Fifty-seven companies claiming small business status won 440 licenses. An auction of MEA and Economic Area
(EA)licenses commenced on October 30, 2001, and closed on December 5, 2001. Of the 15,514 licenses auctioned, 5,323 were sold. One hundred thirty-two companies claiming small business status purchased 3,724 licenses. A third auction, consisting of 8,874 licenses in each of 175 EAs and 1,328 licenses in all but three of the 51 MEAs commenced on May 13, 2003, and closed on May 28, 2003. Seventy-seven bidders claiming small or very small business status won 2,093 licenses. Currently, there are approximately 74,000 Common Carrier Paging licenses. According to the most recent Trends in Telephone Service, 408 private and common carriers reported that they were engaged in the provision of either paging or “other mobile” services. Of these, we estimate that 589 are small, under the SBA-approved small business size standard. We estimate that the majority of common carrier paging providers would qualify as small entities under the SBA definition. 34. Wireless Communications Services. This service can be used for fixed, mobile, radiolocation, and digital audio broadcasting satellite uses. The Commission defined “small business” for the wireless communications services
(WCS)auction as an entity with average gross revenues of $40 million for each of the three preceding years, and a “very small business” as an entity with average gross revenues of $15 million for each of the three preceding years. The SBA has approved these definitions. The Commission auctioned geographic area licenses in the WCS service. In the auction, which commenced on April 15, 1997 and closed on April 25, 1997, there were seven bidders that won 31 licenses that qualified as very small business entities, and one bidder that won one license that qualified as a small business entity. An auction for one license in the 1670-1674 MHz band commenced on April 30, 2003 and closed the same day. One license was awarded. The winning bidder was not a small entity. 35. Wireless Telephony. Wireless telephony includes cellular, personal communications services, and specialized mobile radio telephony carriers. The SBA has developed a small business size standard for “Cellular and Other Wireless Telecommunications” services. Under the SBA small business size standard, a business is small if it has 1,500 or fewer employees. According to Trends in Telephone Service data, 437 carriers reported that they were engaged in wireless telephony. We have estimated that 260 of these are small under the SBA small business size standard. 36. Broadband Personal Communications Service. The broadband personal communications services
(PCS)spectrum is divided into six frequency blocks designated A through F, and the Commission has held auctions for each block. The Commission has created a small business size standard for Blocks C and F as an entity that has average gross revenues of less than $40 million in the three previous calendar years. For Block F, an additional small business size standard for “very small business” was added and is defined as an entity that, together with its affiliates, has average gross revenues of not more than $15 million for the preceding three calendar years. These small business size standards, in the context of broadband PCS auctions, have been approved by the SBA. No small businesses within the SBA-approved small business size standards bid successfully for licenses in Blocks A and B. There were 90 winning bidders that qualified as small entities in the Block C auctions. A total of 93 “small” and “very small” business bidders won approximately 40 percent of the 1,479 licenses for Blocks D, E, and F. On March 23, 1999, the Commission reauctioned 155 C, D, E, and F Block licenses; there were 113 small business winning bidders. 38. On January 26, 2001, the Commission completed the auction of 422 C and F Broadband PCS licenses in Auction No. 35. Of the 35 winning bidders in this auction, 29 qualified as “small” or “very small” businesses. Subsequent events, concerning Auction 35, including judicial and agency determinations, resulted in a total of 163 C and F Block licenses being available for grant. On February 15, 2005, the Commission completed an auction of 188 C Block licenses and 21 F Block licenses in Auction No. 58. There were 24 winning bidders for 217 licenses. Of the 24 winning bidders, 16 claimed small business status and won 156 licenses. 39. Narrowband Personal Communications Services. The Commission held an auction for Narrowband PCS licenses that commenced on July 25, 1994, and closed on July 29, 1994. A second auction commenced on October 26, 1994 and closed on November 8, 1994. For purposes of the first two Narrowband PCS auctions, “small businesses” were entities with average gross revenues for the prior three calendar years of $40 million or less. Through these auctions, the Commission awarded a total of 41 licenses, 11 of which were obtained by four small businesses. To ensure meaningful participation by small business entities in future auctions, the Commission adopted a two-tiered small business size standard in the Narrowband PCS Second Report and Order. A “small business” is an entity that, together with affiliates and controlling interests, has average gross revenues for the three preceding years of not more than $40 million. A “very small business” is an entity that, together with affiliates and controlling interests, has average gross revenues for the three preceding years of not more than $15 million. The SBA has approved these small business size standards. A third auction commenced on October 3, 2001 and closed on October 16, 2001. Here, five bidders won 317 (Metropolitan Trading Areas and nationwide) licenses. Three of these claimed status as a small or very small entity and won 311 licenses. 40. Lower 700 MHz Band Licenses. We adopted criteria for defining three groups of small businesses for purposes of determining their eligibility for special provisions such as bidding credits. We have defined a “small business” as an entity that, together with its affiliates and controlling principals, has average gross revenues not exceeding $40 million for the preceding three years. A “very small business” is defined as an entity that, together with its affiliates and controlling principals, has average gross revenues that are not more than $15 million for the preceding three years. Additionally, the lower 700 MHz Service has a third category of small business status that may be claimed for Metropolitan/Rural Service Area (MSA/RSA) licenses. The third category is “entrepreneur,” which is defined as an entity that, together with its affiliates and controlling principals, has average gross revenues that are not more than $3 million for the preceding three years. The SBA has approved these small size standards. An auction of 740 licenses (one license in each of the 734 MSAs/RSAs and one license in each of the six Economic Area Groupings (EAGs)) commenced on August 27, 2002, and closed on September 18, 2002. Of the 740 licenses available for auction, 484 licenses were sold to 102 winning bidders. Seventy-two of the winning bidders claimed small business, very small business or entrepreneur status and won a total of 329 licenses. A second auction commenced on May 28, 2003, and closed on June 13, 2003, and included 256 licenses: 5 EAG licenses and 476 Cellular Market Area licenses. Seventeen winning bidders claimed small or very small business status and won 60 licenses, and nine winning bidders claimed entrepreneur status and won 154 licenses. On July 26, 2005, the Commission completed an auction of 5 licenses in the Lower 700 MHz band (Auction No. 60). There were three winning bidders for five licenses. All three winning bidders claimed small business status. 41. Upper 700 MHz Band Licenses. In *Service Rules for the 746-764 and 776-794 MHz Bands* , 16 FCC Rcd 1239 (January 12, 2001), the Commission authorized service in the upper 700 MHz band. This auction, previously scheduled for January 13, 2003, has been postponed. 42. 700 MHz Guard Band Licenses. In the 700 MHz Guard Band Order, we adopted size standards for “small businesses” and “very small businesses” for purposes of determining their eligibility for special provisions such as bidding credits and installment payments. A small business in this service is an entity that, together with its affiliates and controlling principals, has average gross revenues not exceeding $40 million for the preceding three years. Additionally, a very small business is an entity that, together with its affiliates and controlling principals, has average gross revenues that are not more than $15 million for the preceding three years. SBA approval of these definitions is not required. An auction of 52 Major Economic Area
(MEA)licenses commenced on September 6, 2000, and closed on September 21, 2000. Of the 104 licenses auctioned, 96 licenses were sold to nine bidders. Five of these bidders were small businesses that won a total of 26 licenses. A second auction of 700 MHz Guard Band licenses commenced on February 13, 2001, and closed on February 21, 2001. All eight of the licenses auctioned were sold to three bidders. One of these bidders was a small business that won a total of two licenses. 43. Fixed Microwave Services. Fixed microwave services include common carrier, private operational-fixed, and broadcast auxiliary radio services. At present, there are approximately 22,015 common carrier fixed licensees and 61,670 private operational-fixed licensees and broadcast auxiliary radio licensees in the microwave services. The Commission has not created a size standard for a small business specifically with respect to fixed microwave services. For purposes of this analysis, the Commission uses the SBA small business size standard for the category “Cellular and Other Telecommunications,” which is 1,500 or fewer employees. The Commission does not have data specifying the number of these licensees that have no more than 1,500 employees, and thus are unable at this time to estimate with greater precision the number of fixed microwave service licensees that would qualify as small business concerns under the SBA's small business size standard. Consequently, the Commission estimates that there are 22,015 or fewer common carrier fixed licensees and 61,670 or fewer private operational-fixed licensees and broadcast auxiliary radio licensees in the microwave services that may be small and may be affected by the rules and policies proposed herein. We note, however, that the common carrier microwave fixed licensee category includes some large entities. 44. 39 GHz Service. The Commission created a special small business size standard for 39 GHz licenses—an entity that has average gross revenues of $40 million or less in the three previous calendar years. An additional size standard for “very small business” is: An entity that, together with affiliates, has average gross revenues of not more than $15 million for the preceding three calendar years. The SBA has approved these small business size standards. The auction of the 2,173 39 GHz licenses began on April 12, 2000 and closed on May 8, 2000. The 18 bidders who claimed small business status won 849 licenses. 45. Local Multipoint Distribution Service. Local Multipoint Distribution Service
(LMDS)is a fixed broadband point-to-multipoint microwave service that provides for two-way video telecommunications. The auction of the 986 Local Multipoint Distribution Service
(LMDS)licenses began on February 18, 1998 and closed on March 25, 1998. The Commission established a small business size standard for LMDS licenses as an entity that has average gross revenues of less than $40 million in the three previous calendar years. An additional small business size standard for “very small business” was added as an entity that, together with its affiliates, has average gross revenues of not more than $15 million for the preceding three calendar years. The SBA has approved these small business size standards in the context of LMDS auctions. There were 93 winning bidders that qualified as small entities in the LMDS auctions. A total of 93 small and very small business bidders won approximately 277 A Block licenses and 387 B Block licenses. On March 27, 1999, the Commission re-auctioned 161 licenses; there were 32 small and very small businesses that won 119 licenses. 46. 218-219 MHz Service. The first auction of 218-219 MHz (previously referred to as the Interactive and Video Data Service or IVDS) spectrum resulted in 178 entities winning licenses for 594 Metropolitan Statistical Areas (MSAs). Of the 594 licenses, 567 were won by 167 entities qualifying as a small business. For that auction, we defined a small business as an entity that, together with its affiliates, has no more than a $6 million net worth and, after federal income taxes (excluding any carry over losses), has no more than $2 million in annual profits each year for the previous two years. In the 218-219 MHz Report and Order and Memorandum Opinion and Order, we defined a small business as an entity that, together with its affiliates and persons or entities that hold interests in such an entity and their affiliates, has average annual gross revenues not exceeding $15 million for the preceding three years. A very small business is defined as an entity that, together with its affiliates and persons or entities that hold interests in such an entity and its affiliates, has average annual gross revenues not exceeding $3 million for the preceding three years. The SBA has approved of these definitions. A subsequent auction is not yet scheduled. Given the success of small businesses in the previous auction, and the prevalence of small businesses in the subscription television services and message communications industries, we assume for purposes of this analysis that in future auctions, many, and perhaps most, of the licenses may be awarded to small businesses. 47. Rural Radiotelephone Service. The Commission has not adopted a size standard for small businesses specific to the Rural Radiotelephone Service. A significant subset of the Rural Radiotelephone Service is the Basic Exchange Telephone Radio System (BETRS). In the present context, we will use the SBA's small business size standard applicable to “Cellular and Other Wireless Telecommunications,” i.e., an entity employing no more than 1,500 persons. There are approximately 1,000 licensees in the Rural Radiotelephone Service, and the Commission estimates that there are 1,000 or fewer small entity licensees in the Rural Radiotelephone Service that may be affected by the rules and policies proposed herein. 48. Incumbent 24 GHz Licensees. This analysis may affect incumbent licensees who were relocated to the 24 GHz band from the 18 GHz band, and applicants who wish to provide services in the 24 GHz band. The applicable SBA small business size standard is that of “Cellular and Other Wireless Telecommunications” companies. This category provides that such a company is small if it employs no more than 1,500 persons. For the census category of Paging, Census Bureau data for 2002 show that there were 807 firms in this category that operated for the entire year. Of this total, 804 firms had employment of 999 or fewer employees, and three firms had employment of 1,000 employees or more. Thus, under this category and associated small business size standard, the majority of firms can be considered small. For the census category of Cellular and Other Wireless Telecommunications, Census Bureau data for 2002 show that there were 1,397 firms in this category that operated for the entire year. Of this total, 1,378 firms had employment of 999 or fewer employees, and 19 firms had employment of 1,000 employees or more. Thus, under this second category and size standard, the majority of firms can, again, be considered small. These broader census data notwithstanding, we believe that there are only two licensees in the 24 GHz band that were relocated from the 18 GHz band, Teligent and TRW, Inc. It is our understanding that Teligent and its related companies have fewer than 1,500 employees, though this may change in the future. TRW is not a small entity. Thus, only one incumbent licensee in the 24 GHz band is a small business entity. 49. Future 24 GHz Licensees. With respect to new applicants in the 24 GHz band, we have defined “small business” as an entity that, together with controlling interests and affiliates, has average annual gross revenues for the three preceding years not exceeding $15 million. “Very small business” in the 24 GHz band is defined as an entity that, together with controlling interests and affiliates, has average gross revenues not exceeding $3 million for the preceding three years. The SBA has approved these definitions. The Commission will not know how many licensees will be small or very small businesses until the auction, if required, is held. D. Description of Projected Reporting, Recordkeeping and Other Compliance Requirements 50. Should the Commission decide to adopt any procedural rules governing petitions for forbearance, the associated rules potentially could modify or impose new reporting or recordkeeping requirements. For example, we seek comment on the possible need for rules governing the form and content of forbearance petitions, such as “complete-as-filed” requirements and obligations for forbearance petitioners to demonstrate that they have satisfied each element of the forbearance standard. The Commission also seeks comment on the possible need or rules governing the scope and interpretation of protective orders in forbearance proceedings, including rules governing the submission of, access to, and use of information submitted pursuant to protective orders in forbearance proceedings. In addition, we seek comment on the need for rules establishing timetables for Commission proceedings addressing forbearance petitions, including requirements governing modification of forbearance petitions and processes for ex parte filings. We further seek comment on whether we should adopt procedural requirements governing petitions for reconsideration of forbearance decisions. The Commission also seeks comment on the need for any other procedural rules governing forbearance petitions, the scope of application of such rules, and the appropriate remedies for violation should the Commission adopt such rules. These proposals may impose additional reporting and recordkeeping requirements on entities. Also, we seek comment on the effects of any of these proposals on small entities. Entities, especially small businesses, are encouraged to quantify the costs and benefits or any reporting requirement that may be established in this proceeding. E. Steps Taken To Minimize Significant Economic Impact on Small Entities, and Significant Alternatives Considered 51. The RFA requires an agency to describe any significant alternatives that it has considered in reaching its proposed approach, which may include (among others) the following four alternatives:
(1)The establishment of differing compliance or reporting requirements or timetables that take into account the resources available to small entities;
(2)the clarification, consolidation, or simplification of compliance or reporting requirements under the rule for small entities;
(3)the use of performance, rather than design, standards; and
(4)an exemption from coverage of the rule, or any part thereof, for small entities. 52. The Commission's primary objective is to implement the “pro-competitive, deregulatory” framework established in sections 10 and 332 of the Act. We seek comment on the burdens, including those placed on small carriers, associated with related Commission rules and whether the Commission should adopt different requirements for small businesses. F. Federal Rules That May Duplicate, Overlap, or Conflict With the Proposed Rules 53. None. Ordering Clauses 54. Accordingly, *it is ordered* that pursuant to sections 1, 4(i), 4(j), 10, 303, 332 and 403 of the Communications Act of 1934, as amended, 47 U.S.C. 151, 154(i)-(j), 160, 303, 332, 403, this Notice of Proposed Rulemaking in WC Docket No. 07-267 *is adopted* . 55. *It is further ordered* that the Covad, et al. Petition to Establish Procedural Requirements to Govern Proceedings for Forbearance Under Section 10 of the Communications Act of 1934, as Amended, WC Docket No. 07-267 (filed Sept. 19, 2007), *is granted* to the extent indicated herein and otherwise *is denied* . 56. *It is further ordered* that the Commission's Consumer and Governmental Affairs Bureau, Reference Information Center, *shall send* a copy of this *NPRM* , including the Initial Regulatory Flexibility Analysis, to the Chief Counsel for Advocacy of the Small Business Administration. Federal Communications Commission. Marlene H. Dortch, Secretary. [FR Doc. E8-2180 Filed 2-5-08; 8:45 am] BILLING CODE 6712-01-P DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Parts 223 and 226 [Docket No. 070801431-7787-01] RIN 0648-AV35 Endangered and Threatened Species; Critical Habitat for Threatened Elkhorn and Staghorn Corals AGENCY: National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce. ACTION: Proposed rule; request for comments. SUMMARY: We, the National Marine Fisheries Service (NMFS), propose to designate critical habitat for elkhorn ( *Acropora palmata* ) and staghorn ( *A. cervicornis* ) corals, which we listed as threatened under the Endangered Species Act of 1973, as amended (ESA), on May 9, 2006. Four specific areas are proposed for designation: the Florida unit, which comprises approximately 3,301 square miles (8,671 sq km) of marine habitat; the Puerto Rico unit, which comprises approximately 1,383 square miles (3,582 sq km) of marine habitat; the St. John/St. Thomas unit, which comprises approximately 121 square miles (313 sq km) of marine habitat; and the St. Croix unit, which comprises approximately 126 square miles (326 sq km) of marine habitat. We propose to exclude one military site, comprising approximately 47 square miles (123 sq km), because of national security impacts. We are soliciting comments from the public on all aspects of the proposal, including our identification and consideration of the positive and negative economic, national security, and other relevant impacts of the proposed designation, and the areas we propose to exclude from the designation. A draft impacts report prepared pursuant to section 4(b)(2) of the ESA in support of this proposal is also available for public review and comment. DATES: Comments on this proposal must be received by May 6, 2008. Public hearings will be held; see SUPPLEMENTARY INFORMATION for dates and locations. ADDRESSES: You may submit comments, identified by the Regulation Identifier Number
(RIN)0648-AV35, by any of the following methods: Electronic Submissions: Submit all electronic public comments via the Federal eRulemaking Portal: *http://www.regulations.gov* . Mail: Assistant Regional Administrator, Protected Resources Division, NMFS, Southeast Regional Office, 263 13th Ave. South, St. Petersburg, FL 33701. Facsimile
(fax): 727-824-5309. Instructions: All comments received are a part of the public record and will generally be posted to *http://www.regulations.gov* without change. All Personal Identifying Information (for example, name, address, etc.) voluntarily submitted by the commenter may be publicly accessible. Do not submit Confidential Business Information or otherwise sensitive or protected information. NMFS will accept anonymous comments. Attachments to electronic comments will be accepted in Microsoft Word, Excel, WordPerfect, or Adobe PDF file formats only. *Public Hearing:* See SUPPLEMENTARY INFORMATION for hearing dates and locations. FOR FURTHER INFORMATION CONTACT: Jennifer Moore or Sarah Heberling, NMFS, at the address above or at 727-824-5312; or Marta Nammack, NMFS, at 301-713-1401. SUPPLEMENTARY INFORMATION: Background On May 9, 2006, we listed elkhorn and staghorn corals as threatened under the ESA (71 FR 26852; May 9, 2006). At the time of listing, we also announced our intention to propose critical habitat for elkhorn and staghorn corals. We are proposing to designate critical habitat for both species through one rule; due to their similar life histories, distribution, threats, and conservation requirements, critical habitat for these coral species is overlapping. Elkhorn and Staghorn Coral Natural History The following discussion of the life history and reproductive biology of threatened corals is based on the best scientific data available, including the Atlantic *Acropora* Status Review Report (Acropora Biological Review Team, 2005), and additional information, particularly concerning the genetics of these corals. *Acropora* spp. are widely distributed throughout the Caribbean (U.S.—Florida, Puerto Rico, U.S. Virgin Islands (U.S.V.I.), Navassa; and Antigua and Barbuda, Aruba, Bahamas, Barbados, Belize, British Virgin Islands, Colombia, Costa Rica, Cuba, Dominica, Dominican Republic, Grenada, Guadeloupe, Haiti, Honduras, Jamaica, Martinique, Mexico, Netherlands Antilles, Nicaragua, Panama, St. Kitts and Nevis, St. Lucia, St. Vincent and the Grenadines, Trinidad and Tobago, and Venezuela). In general, elkhorn and staghorn corals have the same geographic distribution, with few exceptions. The northern extent (Palm Beach County, Florida) of staghorn coral occurrence is farther north than that of elkhorn coral (Broward County, Florida). Staghorn coral commonly grows in more protected, deeper water ranging from 5 to 20 m in depth and has been found in rare instances to 60 m. Elkhorn coral commonly grows in turbulent shallow water on the seaward face of reefs in water ranging from 1 to 5 m in depth but has been found to 30 m depth. Elkhorn and staghorn corals were once the most abundant and most important species on Caribbean coral reefs in terms of accretion of reef structure. Relative to other corals, elkhorn and staghorn corals have high growth rates that have allowed reef growth to keep pace with past changes in sea level. Both species exhibit branching morphologies that provide important habitat for other reef organisms. Environmental influences (e.g., wave action, currents) result in morphological variation (e.g., length, shape of branches) in both species. Staghorn coral is characterized by staghorn antler-like colonies with cylindrical, straight, or slightly curved branches. The diameter of staghorn coral branches ranges from 1 to 4 cm, and tissue color ranges from golden yellow to medium brown. The growing tips of staghorn coral tend to be lighter or lack color. The linear growth rate for staghorn coral has been reported to range from 3 to 11.5 cm/year. Today, staghorn coral colonies typically exist as isolated branches and small thickets, 0.5 to 1 m across in size, unlike the vast fields (thickets) of staghorn found commonly during the 1970s. Elkhorn coral is the larger species of *Acropora* found in the Atlantic. Colonies are flattened to near round with frond-like branches. Branches are up to 50 cm across and range in thickness from 2 to 10 cm, tapering towards the branch terminal. Like staghorn coral, branches are white near the growing tip, and brown to tan away from the growing area. The linear growth rate for elkhorn coral is reported to range from 4 to 11 cm/year. Individual colonies can grow to at least 2 m in height and 4 m in diameter. Elkhorn and staghorn corals require relatively clear, well-circulated water and are almost entirely dependent upon sunlight for nourishment. Unlike other coral species, neither acroporid species is likely to compensate for long-term reductions in water clarity with alternate food sources, such as zooplankton and suspended particulate matter. Typical water temperatures in which *Acropora* spp. occur from 21 to 29 °C, with the species being able to tolerate temperatures higher than the seasonal maximum for a brief period of time (days to weeks depending on the magnitude of the temperature elevation). The species' response to temperature perturbations is dependent on the duration and intensity of the event. Both acroporids are susceptible to bleaching (loss of symbiotic algae) under adverse environmental conditions. *Acropora* spp. reproduce both sexually and asexually. Elkhorn and staghorn corals do not differ substantially in their sexual reproductive biology. Both species are broadcast spawners: male and female gametes are released into the water column where fertilization takes place. Additionally, both species are simultaneous hermaphrodites, meaning that a given colony will contain both male and female reproductive parts during the spawning season; however, an individual colony or clone will not produce viable offspring. The spawning season for elkhorn and staghorn corals is relatively short, with gametes released on only a few nights during July, August, and/or September. In most populations, spawning is synchronous after the full moon during any of these 3 months. Larger colonies of elkhorn and staghorn corals have much higher fecundity rates (Soong and Lang, 1992). In elkhorn and staghorn corals, fertilization and development are exclusively external. Embryonic development culminates with the development of planktonic larvae called planulae. Little is known concerning the settlement patterns of planula of elkhorn and staghorn corals. In general, upon proper stimulation, coral larvae, whether released from parental colonies or developed in the water column external to the parental colonies (like *Acropora* spp.), settle and metamorphose on appropriate substrates. Like most corals, elkhorn and staghorn corals require hard, consolidated substrate, including attached, dead coral skeleton, for their larvae to settle. Unlike most other coral larvae, elkhorn (and presumably staghorn) planulae appear to prefer settling on upper, exposed surfaces, rather than in dark, cryptic ones, at least in a laboratory setting (Szmant and Miller, 2005). Coral planula larvae experience considerable mortality (90 percent or more) from predation or other factors prior to settlement and metamorphosis (Goreau, *et al.* , 1981). Because newly settled corals barely protrude above the substrate, juveniles need to reach a certain size to reduce damage or mortality from impacts such as grazing, sediment burial, and algal overgrowth. Recent studies examining early survivorship indicated that lab cultured elkhorn coral settled onto experimental limestone plates and placed in the field had substantially higher survivorship than another spawning coral species, *Montastraea faveolata* , and similar survivorship to brooding coral species (species that retain developing larvae within the parent polyp until an advanced stage) over the first 9 months following settlement (Szmant and Miller, 2005). This pattern corresponds to the size of planulae; elkhorn coral eggs and larvae are much larger than those of *Montastraea* spp. Overall, older recruits (i.e., those that survive to a size where they are visible to the human eye, probably 1 to 2 years post-settlement) of *Acropora* spp. appear to have similar growth and post-settlement mortality rates observed in other coral species. Studies of *Acropora* spp. from across the Caribbean confirm two overall patterns of sexual recruitment:
(1)Low juvenile densities relative to other coral species; and
(2)low juvenile densities relative to the commonness of adults (Porter, 1987). This pattern suggests that the composition of the adult population is based upon variable recruitment. To date, the settlement rates for *Acropora* spp. have not been quantified. Few data on the genetic population structure of elkhorn and staghorn corals exist; however, due to recent advances in technology, the genetic population structure of the current, depleted population is beginning to be characterized. Baums, *et al.*
(2005)examined the genetic exchange in elkhorn coral by sampling and genotyping colonies from 11 locations throughout its geographic range using microsatellite markers. Results indicate that elkhorn populations in the eastern Caribbean (St. Vincent and the Grenadines, U.S.V.I., Curacao, and Bonaire) have experienced little or no genetic exchange with populations in the western Caribbean (Bahamas, Florida, Mexico, Panama, Navassa, and Mona Island). Mainland Puerto Rico is an area of mixing where elkhorn populations show genetic contribution from both regions, though it is more closely connected with the western Caribbean. Within these regions, the degree of larval exchange appears to be asymmetrical, with some locations being entirely self-recruiting and some receiving immigrants from other locations within their region. Vollmer and Palumbi
(2007)examined multilocus sequence data from 276 colonies of staghorn coral spread across 22 populations from 9 regions in the Caribbean, Florida, and the Bahamas. Their data were consistent with the Western-Eastern Caribbean subdivision observed in elkhorn coral populations by Baums, *et al.* (2005). Additionally, the data indicated that regional populations of staghorn separated by greater than 500 km are genetically differentiated and that gene flow across the greater Caribbean is low in staghorn coral. This is consistent with studies conducted on other Caribbean corals showing that gene flow is restricted at spatial scales over 500 km (Fukami, *et al.* , 2004; Baums, *et al.* , 2005; Brazeau, *et al.* , 2005). Furthermore, fine-scale genetic differences were observed among reefs separated by as little as 2 km, suggesting that gene flow in staghorn corals may be limited over much smaller spatial scales (Vollmer and Palumbi, 2007). Both acroporid population studies suggest that no population is more or less significant to the status of the species. Staghorn coral populations on one reef exhibit limited ability to seed another population separated by large distances. Elkhorn coral populations are genetically related over larger geographic distances; however, because sexual recruitment levels are extremely low, re-seeding potential is also minimal. This regional population structure suggests that conservation should be implemented at local to regional scales because relying on long-distance larval dispersal as a means of recovery may be unreliable and infeasible. Therefore, protecting source populations, in relatively close proximity to each other (<500 km), is likely the more effective conservation alternative (Vollmer and Palumbi, 2007). Elkhorn and staghorn corals, like most coral species, also reproduce asexually. Asexual reproduction involves fragmentation, wherein colony pieces or fragments break from a larger colony and re-attach to hard, consolidated substrate to form a new colony. Reattachment occurs when:
(1)Live coral tissue on the fragment overgrows suitable substrate where it touches after falling; or
(2)encrusting organisms settle on the dead basal areas of the fragment and cement it to the adjacent substrate (Tunnicliffe, 1981). Fragmentation results in multiple colonies (ramets) that are genetically identical, while sexual reproduction results in the creation of new genotypes (genets). Fragmentation is the most common means of forming new elkhorn and staghorn coral colonies in most populations and plays a major role in maintaining local populations when sexual recruitment is limited. The larger size of fragments compared to planulae may result in higher survivorship after recruitment (Jackson, 1977, as cited by Lirman, 2000). Also unlike sexual reproduction, which is restricted seasonally for elkhorn coral (Szmant, 1986, as cited by Lirman, 2000), fragmentation can take place year-round. Critical Habitat Identification and Designation Critical habitat is defined by section 3 of the ESA (and further by 50 CFR 424.02(d)) as “(i) the specific areas within the geographical area occupied by the species, at the time it is listed in accordance with the provisions of section 4 of this Act, on which are found those physical or biological features
(I)essential to the conservation of the species and
(II)which may require special management considerations or protection; and
(ii)specific areas outside the geographical area occupied by the species at the time it is listed in accordance with the provisions of section 4 of this Act, upon a determination by the Secretary that such areas are essential for the conservation of the species.” This definition provides a step-wise approach to identifying areas that may be designated as critical habitat for listed corals. Geographical Areas Occupied by the Species The best scientific data available show the current geographical area occupied by both elkhorn and staghorn corals has remained unchanged from their historical ranges. In other words, there is no evidence of range constriction for either species. “Geographical areas occupied” in the definition of critical habitat is interpreted to mean the current range of the species and not every discrete location on which individuals of the species physically are located (45 FR 13011; February 27, 1980). In general, elkhorn and staghorn corals have the same distribution, with few exceptions, and are widely distributed throughout the Caribbean. *The Status of Coral Reefs in the Western Atlantic: Results of Initial Surveys, Atlantic and Gulf Rapid Reef Assessment (AGRRA) Program* (Lang, 2003) provides results (1997-2004) of a regional systematic survey of corals, including *Acropora* spp., from many locations throughout the Caribbean. AGRRA data (1997-2004) indicate that the historic range of both species remains intact; staghorn coral is rare throughout the range (including areas of previously known dense occurrence); and elkhorn coral occurs in moderation. We also collected data and information pertaining to the geographical area occupied by these species at the time of listing by partnering with our Southeast Fisheries Science Center (SEFSC), NOAA National Centers for Coastal Ocean Science Biogeography Team, and the U.S. Geological Survey of the Department of the Interior. These partnerships resulted in the collection of geographic information system
(GIS)and remote sensing data (e.g., benthic habitat data, water depth, and presence/absence location data for *Acropora* spp. colonies), which we supplemented with relevant information collected from the public during comment periods and workshops held throughout the ESA listing process. In Southeast Florida, staghorn coral has been documented along the east coast as far north as Palm Beach County in deeper (16 to 30 m) water (Goldberg, 1973) and is distributed south and west throughout the coral and hardbottom habitats of the Florida Keys (Jaap, 1984), through Tortugas Bank. Elkhorn coral has been reported as far north as Broward and Miami-Dade Counties, with significant reef development and framework construction by this species beginning at Ball Buoy Reef in Biscayne National Park, extending discontinuously southward to the Dry Tortugas. In Puerto Rico, elkhorn and staghorn corals have been reported in patchy abundance around the main island and isolated offshore locations. In the late 1970s, both elkhorn and staghorn corals occurred in dense and well developed thickets on many reefs off the northeast, east, south, west and northwest coast, and also the offshore islands of Mona, Vieques and Culebra (Weil, *et al.* , unpublished data). Dense, high profile, monospecific thickets of elkhorn and staghorn corals have been documented in only a few reefs along the southwest shore of the main island and isolated offshore locations (Weil, *et al.* , unpublished data) though recent monitoring data for the presence of coral are incomplete in coverage around the islands. Further, the species have been recently documented along the west (e.g., Rincon) and northeast coasts (e.g., La Cordillera). Additionally, large stands of dead elkhorn currently exist on the fringing coral reefs along the south shoreline (e.g., Punta Picúa, Punta Miquillo, Río Grande, Guánica, La Parguera, Mayaguez). It appears that elkhorn and staghorn are rare on the north shore of Puerto Rico; however, there is a thin strip of hardbottom substrate on that shore, which may be supporting additional unrecorded colonies of elkhorn or staghorn. The U.S.V.I. also supports populations of elkhorn and staghorn corals, particularly at Buck Island Reef National Monument. St. Croix has coral reef and colonized hardbottom surrounding the entire island. Data from the 1980's indicate that the species were present along the north, eastern, and western shores at that time. The GIS data we compiled indicate the presence of elkhorn and staghorn currently along the north, northeastern, south, and southeastern shores of St. Croix. Monitoring data are incomplete, and it is possible that unrecorded colonies are present along the western, northwestern, or southwestern shores. For the islands of St. Thomas and St. John, there are limited GIS presence data available for elkhorn and staghorn corals. However, Grober-Dunsmore, *et al.*
(2006)show that from 2001-2003, elkhorn colonies were distributed in many locations around the island of St. John. Additionally, the data we have indicate coral reef and coral-colonized hard bottom surrounding each of these islands as well as the smaller offshore islands. Again, it is possible that unrecorded colonies are present in these areas. Navassa Island is a small, uninhabited, oceanic island approximately 50 km off the southwest tip of Haiti managed by U.S. Fish and Wildlife Service
(FWS)as one component of the Caribbean Islands National Wildlife Refuge (NWR). Both acroporid species are known from Navassa, with elkhorn apparently increasing in abundance and staghorn rare (Miller and Gerstner, 2002). Last, there are two known colonies of elkhorn at the Flower Garden Banks National Marine Sanctuary (FGBNMS), located 100 mi (161 km) off the coast of Texas in the Gulf of Mexico. The FGBNMS is a group of three areas of salt domes that rise to approximately 15 m water depth and are surrounded by depths from 60 to 120 m. The FGBNMS is regularly surveyed, and the two known colonies, which were only recently discovered and are considered to be a potential range expansion, are constantly monitored. Our regulations at 50 CFR 424.12(h) state: “Critical habitat shall not be designated within foreign countries or in other areas outside of United States jurisdiction.” Although the geographical area occupied by elkhorn and staghorn corals includes coastal waters of many Caribbean and Central and South American nations, we are not proposing these areas for designation. The geographical area occupied by listed coral species which is within the jurisdiction of the United States is therefore limited to four counties in the State of Florida (Palm Beach County, Broward County, Miami-Dade County, and Monroe County), FGBNMS, and the U.S. territories of Puerto Rico, U.S.V.I, and Navassa Island. Physical or Biological Features Essential for Conservation (Primary Constituent Elements) Within the geographical area occupied, critical habitat consists of specific areas on which are found those physical or biological features essential to the conservation of the species (hereafter also referred to as essential features or “Primary Constituent Elements” or “PCEs”). Section 3 of the ESA (16 U.S.C. 1532(3)) defines the terms “conserve,” “conserving,” and “conservation” to mean: “To use, and the use of, all methods and procedures which are necessary to bring any endangered species or threatened species to the point at which the measures provided pursuant to this chapter are no longer necessary.” Further, our regulations at 50 CFR 424.12(b) for designating critical habitat state that physical and biological features that are essential to the conservation of a given species and that may require special management considerations or protection may include, but are not limited to:
(1)Space for individual and population growth, and for normal behavior;
(2)food, water, air, light, minerals, or other nutritional or physiological requirements;
(3)cover or shelter;
(4)sites for breeding, reproduction, rearing of offspring, germination, or seed dispersal; and generally,
(5)habitats that are protected from disturbance or are representative of the historic geographical and ecological distributions of a species. These regulations state that we shall focus on essential features within the specific areas considered for designation. As stated in the Atlantic Acropora Status Review Report (Acropora Biological Review Team, 2005), there are several implications of the current low population sizes of *Acropora* spp. throughout much of the wider Caribbean. First, the number of sexual recruits to a population will be most influenced by larval availability, recruitment, and early juvenile mortality. Because corals cannot move and are dependent upon external fertilization in order to produce larvae, fertilization success declines greatly as adult density declines; this is termed an Allee effect (Levitan 1991). To compound the impact, *Acropora* spp., although hermaphroditic, do not effectively self-fertilize; gametes must be outcrossed with a different genotype to form viable offspring. Thus, in populations where fragmentation is prevalent, the effective density (of genetically distinct adults) will be even lower than colony density. It is highly likely that this type of recruitment limitation (Allee effect) is occurring in some local elkhorn and staghorn populations, given their state of drastically reduced abundance/density. Simultaneously, when adult abundances of elkhorn and staghorn corals are reduced, the source for fragments (to provide for asexual recruitment) is also compromised. These conditions imply that once a threshold level of population decline has been reached (i.e., a density where fertilization success becomes negligible) the chances for recovery are low. Thus, we determined that based on available information, facilitating increased incidence of successful sexual and asexual reproduction is the key objective to the conservation of these species. We then turned to determining the physical or biological features essential to this conservation objective. Currently, sexual recruitment of elkhorn and staghorn corals is limited in some areas and absent in most. Compounding the difficulty of documenting sexual recruitment is the difficulty of visually distinguishing some sexual recruits from asexual recruits (Miller, *et al.* , 2007). Settlement of larvae or attachment of fragments is often unsuccessful, given limited amounts of appropriate habitat due to the shift in benthic community structure from coral-dominated to algae-dominated that has been documented since the 1980s (Hughes and Connell, 1999). Appropriate habitat for elkhorn and staghorn coral recruits to attach and grow consists of hard, consolidated substrate. In addition to being limited, the availability of appropriate habitat for successful sexual and asexual reproduction is susceptible to becoming reduced further because of such factors as fleshy macroalgae overgrowing and preempting the space available for larval settlement, recruitment, and fragment reattachment. Similarly, sediment accumulating on suitable substrate impedes sexual and asexual reproductive success by preempting available substrate and smothering coral recruits. Exacerbating the effect of sedimentation is the presence of turf algae, which traps the sediment, leading to greater amounts of accumulations as compared to bare substrate alone. As described above, features that will facilitate successful larval settlement and recruitment, and reattachment of asexual fragments, are essential to the conservation of elkhorn and staghorn corals. Without successful recruits, the species will not increase in abundance, distribution, and genetic diversity. Elkhorn and staghorn corals, like most corals, require hard, consolidated substrate (i.e., attached, dead coral skeleton or hardbottom) for their larvae to settle or fragments to reattach. The type of substrate available directly influences settlement success and fragment survivorship. Lirman
(2000)demonstrated this in a transplant experiment using elkhorn coral fragments created by a ship grounding. Fifty fragments were collected within 24 hours of fragmentation and assigned to one of the following four types of substrate:
(1)Hardbottom (consolidated carbonate framework),
(2)rubble (loose, dead pieces of elkhorn and staghorn corals),
(3)sand, and
(4)live coral. The results showed that the survivorship of transplanted fragments was significantly affected by the type of substrate, with fragment mortality being the greatest for those transplanted to sandy bottom (58 percent loss within the first month and 71 percent after 4 months). Fragments placed on live adult elkhorn coral colonies fused to the underlying tissue and did not experience any tissue loss; and fragments placed on rubble and hardbottom substrates showed high survivorship. Unlike fragments, coral larvae cannot attach to living coral (Connell, *et al.* , 1997). Larvae can settle and attach to dead coral skeleton (Jordan-Dahlgren, 1992; Bonito and Grober-Dunsmore, 2006) and may settle in particular areas in response to chemical cues from certain species of crustose coralline algae
(CCA)(Morse, *et al.* , 1996; Heyward and Negri, 1999; Harrington and Fabricius, 2004). While algae, including CCA and fleshy macroalgae, is a natural component of healthy reef ecosystems, the recent increase in the dominance of fleshy macroalgae as major space-occupiers on many Caribbean coral reefs impedes the recruitment of new corals. This shift in benthic community structure (from the dominance of stony corals to that of fleshy algae) on Caribbean coral reefs is generally attributed to the greater persistence of fleshy macroalgae under reduced grazing regimes due to human overexploitation of herbivorous fishes (Hughes, 1994) and the regional mass mortality of the herbivorous long-spined sea urchin in 1983-84. Further, impacts to water quality (principally nutrient input) coupled with low herbivore grazing are also believed to enhance fleshy macroalgal productivity. Fleshy macroalgae are able to colonize dead coral skeleton and other available substrate, preempting space available for coral recruitment. The persistence of fleshy macroalgae under reduced grazing regimes has impacts on CCA growth, which may reduce settlement of coral larvae as CCA is thought to provide chemical cues for settlement. Most CCA are susceptible to fouling by fleshy algae, particularly when herbivores are absent (Steneck, 1986). Patterns observed in St. Croix, U.S.V.I., also indicate a strong positive correlation between CCA abundance and herbivory (Steneck, 1997). A study in which Miller, *et al.*
(1999)used cages to exclude large herbivores from the study site resulted in increased cover of both turf algae and macroalgae, and cover of CCA decreased. The response of CCA to the experimental treatment persisted for 2 months following cage removal (Miller, *et al.* , 1999). Additionally, following the mass mortality of the urchin *Diadema antillarum* , significant increases in cover of fleshy and filamentous algae occurred with parallel decreases in cover of CCA (de Ruyter van Steveninck and Bak, 1986; Liddel and Ohlhorst, 1986). The ability of fleshy macroalgae to affect growth and survival of CCA has indirect, yet important, impacts on the ability of coral larvae to successfully settle and recruit. Several studies show that coral recruitment tends to be greater when algal biomass is low (Rogers, *et al.* , 1984; Hughes, 1985; Connell, *et al.* , 1997; Edmunds, *et al.* , 2004; Birrell, *et al.* , 2005; Vermeij, 2006). In addition to preempting space for coral larvae settlement, many fleshy macroalgae produce secondary metabolites with generalized toxicity, which also may inhibit settlement of coral larvae (Kuffner and Paul, 2004). Furthermore, algal turfs can trap sediments (Eckman, *et al.* , 1989; Kendrik, 1991; Steneck, 1997; Purcell, 2000; Nugues and Roberts, 2003; Wilson, *et al.* , 2003; Purcell and Bellwood, 2001), which then creates the potential for algal turfs and sediments to act in combination to hinder coral settlement (Nugues and Roberts, 2003; Birrell, *et al.* , 2005). These turf algae sediment mats also can suppress coral growth under high sediment conditions (Nugues and Roberts, 2003) and may gradually kill the marginal tissues of stony corals with which they come into contact (Dustan, 1977, 1999, as cited by Roy, 2004). Sediments enter the reef environment through many processes that are natural or anthropogenic in origin, including erosion of coastline, resuspension of bottom sediments, terrestrial run-off, and nearshore dredging for coastal construction projects and navigation purposes. The rate of sedimentation affects reef distribution, community structure, growth rates, and coral recruitment (Dutra, *et al.* , 2003). Accumulation of sediment can smother living corals, dead coral skeleton, and exposed hardbottom. Sediment accumulation on dead coral skeletons and exposed hardbottom reduces the amount of available substrate suitable for coral larvae settlement and fragment reattachment (Rogers, 1990; Babcock and Smith, 2002). Accumulation of sediments is also a major cause of mortality in coral recruits (Fabricius, *et al.* , 2003). In some instances, if mortality of coral recruits does not occur under heavy sediment conditions, then settled coral planulae may undergo reverse metamorphosis and not survive (Te, 1992). Sedimentation, therefore, impacts the health and survivorship of all life stages (i.e., fecund adults, fragments, larvae, and recruits) of elkhorn and staghorn corals. Based on the key conservation objective we have identified to date, the natural history of elkhorn and staghorn corals, and their habitat needs, the physical or biological feature of elkhorn and staghorn corals' habitat essential to their conservation is substrate of suitable quality and availability, in water depths from the mean high water
(MHW)line to 30 m, to support successful larval settlement, recruitment, and reattachment of fragments. For purposes of this definition, “substrate of suitable quality and availability” means consolidated hardbottom or dead coral skeleton that is free from fleshy macroalgae cover and sediment cover. This feature is essential to the conservation of these two species due to the extremely limited recruitment currently being observed. We determined that no other environmental features are appropriate or necessary for defining critical habitat for the two corals. Other than the substrate PCE, we cannot conclude that any other sufficiently definable feature of the environment is essential to the corals' conservation. Other features of the corals' environment, such as water temperature, are more appropriately viewed as sources of impacts or stressors that can harm the corals, rather than habitat features that provide a conservation function. Therefore, these stressors would not be analyzed as factors that may contribute to a determination whether the corals' critical habitat is likely to be destroyed or adversely modified. Some environmental features are also subsumed within the definition of the substrate PCE; for instance, substrate free from macroalgal cover would encompass water quality sufficiently free of nutrients. Specific Areas Within the Geographical Area Occupied by the Species The definition of critical habitat further instructs us to identify specific areas on which are found the physical or biological features essential to the species' conservation. Our regulations state that critical habitat will be defined by specific limits using reference points and lines on standard topographic maps of the area, and referencing each area by the State, county, or other local governmental unit in which it is located (50 CFR 424.12(c)). As discussed below, we determined that specific areas in FGBNMS and Navassa National Wildlife Refuge that contain the PCE do not otherwise meet the definition of critical habitat. Hence, in this section we only describe our identification of the specific areas we are proposing to include in this designation. In addition to information obtained from the public, we partnered with SEFSC, NOAA Biogeography Team, and U.S. Geological Survey to obtain GIS and remote sensing data (e.g., benthic habitat data, water depth) to compile existing data to identify and map areas that may contain the identified PCE. The following are the major datasets upon which we relied. NOAA's National Ocean Service
(NOS)and the Florida Fish and Wildlife Research Institute completed The Benthic Habitat Mapping of Florida Coral Reef Ecosystems using a series of 450 aerial photographs collected in 1991-1992. For this mapping effort, coral ecosystem ecologists outlined the boundaries of specific habitat types by interpreting color patterns on the photographs. Benthic habitats were classified into four major categories—corals, seagrasses, hardbottom, and bare substrate—and 24 subcategories, such as sparse seagrass and patch reef. Each habitat type was groundtruthed in the field by divers to validate the photo-interpretation of the aerial photography. Habitat boundaries were georeferenced and digitized to create computer maps. A similar method was followed by NOS using 1999 aerial imagery in developing the Benthic Habitat Mapping of Puerto Rico and the U.S.V.I. Using GIS software, we extracted all areas that could be considered potential recruitment habitat, including hardbottom and coral. The benthic habitat information assisted in identifying any major gaps in the distribution of the substrate PCE. Given uncertainties in the age and resolution of the data, we were unable to identify smaller, discrete specific areas that contained the PCE rather than large, continuous areas. Thus, we concluded that, based upon the best available information, although the PCE is unevenly dispersed throughout the ranges of the species, no major gaps existed in the distribution. We further limited the specific areas to the maximum depth of occurrence of the two corals (i.e., 30 m). The 30-m contour was extracted from the National Geophysical Data Center Coastal Relief Model for Puerto Rico & Virgin Islands, and Florida. Because Puerto Rico and the U.S.V.I. are islands, the contours yielded continuous closed polygons. However, because the two species only occur off specific counties in Florida, we used additional boundaries to close the polygons. The Florida Area consists of all waters contained by the boundary beginning at the MHW line at the north boundary of Palm Beach County; then due east to the 30-m contour; then following the 30-m contour to the intersection with the FKNMS boundary northeast of the Dry Tortugas; then following the FKNMS boundary to the intersection with the COLREGS line (see 33 CFR 80.727, 730, 735, and 740) for Florida Bay; then following the COLREGS line southeast to the intersection with Long Key; then following the COLREGS line and MHW line returning to the beginning point. The COLREGS line separates inland waters from marine waters. Also included are the waters in two shoals southwest of the Dry Tortugas bounded by the 30-m contour. Using the above procedure and consistent with our regulations (50 CFR 424.12(c)), we identified four “specific areas” and a few small adjacent areas (separated from main areas by water depth greater than 30 m) within the geographical area occupied by the species, at the time of listing, that contain the PCE. These areas comprise all waters in the depths of 30 m and shallower to the MHW or COLREG line off:
(1)Palm Beach, Broward, Miami-Dade, and Monroe Counties, including the Marquesas Keys and the Dry Tortugas, Florida;
(2)Puerto Rico and associated Islands;
(3)St. John/St. Thomas, U.S.V.I.; and
(4)St. Croix, U.S.V.I.) (see maps). Within these specific areas, the PCE consists of consolidated hardbottom or dead coral skeleton that are free from fleshy macroalgae cover and sediment cover. The PCE can be found unevenly dispersed throughout these four areas due to trends in macroalgae coverage, and naturally occurring unconsolidated sediment and seagrasses dispersed within the reef ecosystem. A larger number of smaller specific areas could not be identified because the submerged nature of the PCE, the limits of available information on the distribution of the PCE, and limits on mapping methodologies make it infeasible to define the specific areas containing the PCE more finely than described herein. Further, based on data about their historical distributions, the corals are capable of successfully recruiting and attaching to available substrate anywhere within the boundaries of the four specific areas. Given these species' reduced abundances, the four specific areas were identified to include all available potential settling substrate within the 30 m contour to maximize the potential for successful recruitment and population growth. The PCE is not likely to be present in natural sites covered with loose sediment, fleshy macroalgal covered hardbottom, or seagrasses. Additionally, existing man-made structures such as aids-to-navigation (ATONs), artificial reefs, boat ramps, docks, pilings, maintained channels or marinas do not provide the PCE that is essential to the species' conservation. Substrate within the proposed critical habitat boundaries that do not contain the PCE are not part of the designation. Federal actions, or the effects thereof, limited to these areas would not trigger section 7 consultation under the ESA, unless they may affect the species and/or the PCE in adjacent critical habitat. As discussed here and in the supporting impacts analysis, given the precise definition of the proposed PCE, determining whether an action may affect the feature can be accomplished without entering into an ESA section 7 consultation. Unoccupied Areas ESA section 3(5)(A)(ii) further defines critical habitat to include specific areas outside the geographical area occupied if the areas are determined by the Secretary to be essential for the conservation of the species. Regulations at 50 CFR 424.12(e) specify that we shall designate as critical habitat areas outside the geographical area presently occupied by a species only when a designation limited to its present range would be inadequate to ensure the conservation of the species. At the present time, the range of these species has not been constricted, and we have not identified any areas outside the geographical area occupied by the species that are essential for their conservation. Therefore, we are not proposing to designate any unoccupied areas for elkhorn and staghorn corals. Special Management Considerations or Protection Specific areas within the geographical area occupied by a species may be designated as critical habitat only if they contain physical or biological features that “may require special management considerations or protection.” A few courts have interpreted aspects of this statutory requirement, and the plain language aids in its interpretation. For instance, the language clearly indicates the features, not the specific area containing the features, are the focus of the “may require” provision. Use of the disjunctive “or” also suggests the need to give distinct meaning to the terms “special management considerations” and “protection.” Generally speaking, “protection” suggests actions to address a negative impact or threat of a negative impact. “Management” seems plainly broader than protection, and could include active manipulation of a feature or aspects of the environment. Two Federal district courts, focusing on the term “may,” ruled that features can meet this provision based on either present requirements for special management considerations or protections, or on possible future requirements. See, *Center for Biol. Diversity* v. *Norton,* 240 F. Supp. 2d 1090 (D. Ariz. 2003); *Cape Hatteras Access Preservation Alliance* v. *DOI,* 344 F. Supp. 108 (D.D.C. 2004). The Arizona district court ruled that the provision cannot be interpreted to mean that features already covered by an existing management plan must be determined to require “additional” special management, because the term “additional” is not in the statute. Rather, the court ruled that the existence of management plans may be evidence that the features in fact require special management. *Center for Biol. Diversity* v. *Norton,* 1096-1100. NMFS' regulations define “special management considerations or protections” to mean “any methods or procedures useful in protecting physical and biological features of the environment for the conservation of listed species” (50 CFR 424.02(j)). Based on the above, we evaluated whether the PCE proposed in this document may require special management considerations or protections by evaluating four criteria:
(a)Whether there is presently a need to manage the feature;
(b)Whether there is the possibility of a need to manage the feature;
(c)Whether there is presently a negative impact on the feature; or
(d)Whether there is the possibility of a negative impact on the feature. In evaluating present or possible future management needs for the PCE, we recognized that the feature in its present condition must be the basis for a finding that it is essential to the corals' conservation. In addition, the needs for management evaluated in
(a)and
(b)were limited to managing the feature for the conservation of the species. In evaluating whether the PCE meets either criterion
(c)or (d), we evaluated direct and indirect negative impacts from any source (e.g., human or natural). However, we only considered the criteria to be met if impacts affect or have the potential to affect the aspect of the feature that makes it essential to the conservation of the species. We then evaluated whether the PCE met the “may require” provision separately for each of the four “specific areas” proposed for designation, as well as Navassa Island and FGBNMS (discussed later), as management and protection requirements can vary from area to area based on such factors as the legal authorities applicable to areas and the location of the area within the occupied range. Suitable habitat available for larval settlement and recruitment, and asexual fragment reattachment, of these coral species, is particularly susceptible to impacts from human activity because of the shallow water depth range (MHW to 30 m) in which elkhorn and staghorn corals commonly grow. The proximity of this habitat to coastal areas subject this feature to impacts from multiple activities including, but not limited to, dredging and disposal activities, stormwater run-off, coastal and maritime construction, land development, wastewater and sewage outflow discharges, point and non-point source pollutant discharges, fishing, placement of large vessel anchorages, and installation of submerged pipelines or cables. The impacts from these activities, combined with those from natural factors (e.g., major storm events), significantly affect the quality and quantity of available substrate for these threatened species to successfully sexually and asexually reproduce. We concluded that the PCE is currently and will likely continue to be negatively impacted by some or all of these factors in all four specific areas. Overfishing of herbivorous fishes and the mass die-off of long-spined sea urchin *Diadema antillarum* are considered two of the primary contributing factors to the recent shift in benthic community structure from the dominance of stony corals to that of fleshy macroalgae on Caribbean coral reefs. In the absence of fish and urchin grazing or at very low grazing pressures, coral larvae, algae, and numerous other epibenthic organisms settle in high numbers, but most young, developing coral larvae are rapidly outcompeted for space, and their mortality levels are high (Sammarco, 1985). The weight of evidence suggests that competition between algae and corals is widespread on coral reefs and is largely mediated by herbivory (McCook, *et al.* , 2001). An additional factor contributing to the dominance of fleshy macroalgae as major space-occupiers on many Caribbean coral reefs is nutrient enrichment. Nutrients are added to coral reefs from both point sources (readily identifiable inputs where pollutants are discharged to receiving surface waters from a pipe or drain) and non-point sources (inputs that occur over a wide area and are associated with particular land uses). Anthropogenic sources of nutrients include sewage, stormwater and agricultural runoff, river discharge, and groundwater; however, natural oceanographic sources like internal waves and upwelling also distribute nutrients on coral reefs. Coral reefs have been considered to be generally nutrient-limited systems, meaning that levels of accessible nitrogen and phosphorus limit the rates of macroalgae growth. When nutrient levels are raised in such a system, growth rates of fleshy macroalgae can be expected to increase, and this can yield imbalance and changes in community structure. The anthropogenic source routes for nutrients may also bring additional sediments into the coral reef environment. Sources of sediment include erosion of coastline, resuspension of bottom sediments, terrestrial run-off (following clearing of mangroves and deforestation of hillsides), beach renourishment, and nearshore dredging and disposal for coastal construction projects and for navigation purposes. Sediment deposition and accumulation affect the overall amount of suitable substrate available for larval settlement, recruitment, and fragment reattachment (Babcock and Davies, 1991), and both sediment composition and deposition affect the survival of juvenile corals (Fabricius, *et al.* , 2003). The major category of habitat-related activities that may affect the PCE for the two listed corals is water quality management. Activities within this category have the potential to negatively affect the PCE for elkhorn and staghorn corals by altering the quality and availability of suitable substrate for larval settlement, recruitment, and fragment reattachment. Nutrient enrichment, via sewage, stormwater and agricultural runoff, river discharge, and groundwater, is a major factor contributing to this shift in benthic community structure and preemption of available substrate suitable for larval settlement, recruitment, and asexual fragment reattachment. Additionally, sedimentation resulting from land-use practices and from dredging and disposal activities in all four specific areas reduces the overall availability and quality of substrate suitable for successful sexual and asexual reproduction by the two acroporid corals. Thus, the PCE currently needs and will likely continue to need special management or protection. Although they fall within U.S. jurisdiction and may contain the PCE, we are not proposing to include FGBNMS and Navassa National Wildlife Refuge in our critical habitat designation, because we do not believe the PCE in these areas requires special management considerations or protections. Both FGBNMS and Navassa Island are remote marine protected areas and are not currently exposed to the negative impacts and conditions needing management discussed for the other areas above. Additionally, based on available information, we do not expect the PCE found within these two protected areas to experience negative impacts from human or natural sources that would diminish the feature's conservation value to the two coral species. Activities That May Be Affected Section 4(b)(8) of the ESA requires that we describe briefly and evaluate, in any proposed or final regulation to designate critical habitat, those activities that may destroy or adversely modify such habitat or that may be affected by such designation. A wide variety of activities may affect critical habitat and, when carried out, funded, or authorized by a Federal agency, will require an ESA section 7 consultation. Such activities include, but are not limited to, dredging and disposal, beach renourishment, large vessel anchorages, submarine cable/pipeline installation and repair, oil and gas exploration, pollutant discharge, and oil spill prevention and response. Notably, all the activities identified that may affect the critical habitat may also affect the species themselves, if present within the action area of a proposed Federal action. We believe this proposed critical habitat designation will provide Federal agencies, private entities, and the public with clear notification of critical habitat for elkhorn and staghorn corals and the boundaries of the habitat. This designation will allow Federal agencies and others to evaluate the potential effects of their activities on critical habitat to determine if ESA section 7 consultation with NMFS is needed given the specific definition of the PCE above. Consistent with recent agency guidance on conducting adverse modification analyses (NMFS, 2005), we will apply the statutory provisions of the ESA, including those in section 3 that define “critical habitat” and “conservation,” to determine whether a proposed future action might result in the destruction or adverse modification of critical habitat. Application of ESA Section 4(a)(3)(B)(I) Section 4(a)(3)(B) prohibits designating as critical habitat any lands or other geographical areas owned or controlled by the Department of Defense (DOD), or designated for its use, that are subject to an integrated natural resources management plan (INRMP), if we determine that such a plan provides a benefit to the coral species (16 U.S.C. 1533(a)(3)(B)). The legislative history to this provision explains: • “The conferees would expect the [Secretary] to assess an INRMP's potential contribution to species conservation, giving due regard to those habitat protection, maintenance, and improvement projects and other related activities specified in the plan that address the particular conservation and protection needs of the species for which critical habitat would otherwise be proposed. Consistent with current practice, the Secretary would establish criteria that would be used to determine if an INRMP benefits the listed species for which critical habitat would be proposed” (Conference Committee report, 149 Cong. Rec. H. 10563; November 6, 2003). No areas within the specific areas being proposed for designation are covered by relevant INRMPs. Although Naval Air Station Key West (NASKW) is within the specific areas being proposed for designation, the current INRMP was adopted in 2001 and does not address listed corals, nor corals in general. NASKW is in the process of updating the 2001 INRMP and has issued a draft of the document to NMFS for review. If the draft INRMP were to become final and provide a benefit to the two corals as described above, then we would not designate critical habitat within the boundaries covered by the INRMP. NASKW is, however, being proposed for exclusion pursuant to section 4(b)(2), as explained below. Application of ESA Section 4(b)(2) The foregoing discussion described the specific areas within U.S. jurisdiction that fall within the ESA section 3(5) definition of critical habitat in that they contain the physical feature essential to the corals' conservation that may require special management considerations or protection. Before including areas in a designation, section 4(b)(2) of the ESA requires the Secretary to take into consideration the economic impact, impact on national security, and any other relevant impacts of designation of any particular area. Additionally, the Secretary has the discretion to exclude any area from designation if he determines the benefits of exclusion (that is, avoiding some or all of the impacts that would result from designation) outweigh the benefits of designation based upon the best scientific and commercial data available. The Secretary may not exclude an area from designation if exclusion will result in the extinction of the species. Because the authority to exclude is discretionary, exclusion is not required for any particular area under any circumstances. The analysis of impacts below summarizes the comprehensive analysis contained in our Draft Section 4(b)(2) Report, first by considering economic, national security, and other relevant impacts that we projected would result from including each of the four specific areas in the proposed critical habitat designation. This consideration informed our decision on whether to exercise our discretion to propose excluding particular areas from the designation. Both positive and negative impacts were identified and considered (these terms are used interchangeably with benefits and costs, respectively). Impacts were evaluated in quantitative terms where feasible, but qualitative appraisals were used where that is more appropriate to particular impacts. The ESA does not define what “particular areas” means in the context of section 4(b)(2), or the relationship of particular areas to “specific areas” that meet the statute's definition of critical habitat. As there was no biological basis to subdivide the four specific critical habitat areas into smaller units, we treated these areas as the “particular areas” for our initial consideration of impacts of designation. Impacts of Designation The primary impacts of a critical habitat designation result from the ESA section 7(a)(2) requirement that Federal agencies ensure their actions are not likely to result in the destruction or adverse modification of critical habitat. Determining these impacts is complicated by the fact that section 7(a)(2) also requires that Federal agencies ensure their actions are not likely to jeopardize the species' continued existence. One incremental impact of designation is the extent to which Federal agencies modify their proposed actions to ensure they are not likely to destroy or adversely modify the critical habitat beyond any modifications they would make because of listing and the jeopardy requirement. When a modification would be required due to impacts to both the species and critical habitat, the impact of the designation may be co-extensive with the ESA listing of the species. Additional impacts of designation include state and local protections that may be triggered as a result of designation, and positive impacts that may arise from conservation of the species and their habitat, and education of the public to the importance of an area for species conservation. A Draft ESA 4(b)(2) Report describes the impacts analysis in detail (NMFS, 2007). The report describes the projected future Federal activities that would trigger section 7 consultation requirements because they may affect the PCE. Additionally, the report describes the project modifications we identified that may reduce impacts to the PCE, and states whether the modifications are more likely to be solely a result of the critical habitat designation or co-extensive with another regulation, including the ESA listing of the species. The report also identifies the potential national security and other relevant impacts that may arise due to the proposed critical habitat designation. This report is available on NMFS' Southeast Region Web site at *http://sero.nmfs.noaa.gov/pr/esa/acropora.htm* . Economic Impacts As discussed above, economic impacts of the critical habitat designation result through implementation of section 7 of the ESA in consultations with Federal agencies to ensure their proposed actions are not likely to destroy or adversely modify critical habitat. These economic impacts may include both administrative and project modification costs; economic impacts that may be associated with the conservation benefits of the designation are described later. Because elkhorn and staghorn corals are newly listed and we lack a lengthy consultation history for these species, we needed to make assumptions about the types of future Federal activities that might require section 7 consultation under the ESA. We examined the consultation record over the last 10 years, as compiled in our Public Consultation Tracking System
(PCTS)database, to identify types of Federal activities that have the potential to adversely affect elkhorn or staghorn coral critical habitat. We request Federal action agencies to provide us with information on future consultations if our assumptions omitted any future actions likely to affect the proposed critical habitat. We identified 13 categories of activities conducted by 7 Federal action agencies: Airport repair and construction; anchorages; construction of new aids to navigation; beach nourishment and bank stabilization; coastal construction; discharges to navigable waters; dredging and disposal; fishery management; maintenance construction; maintenance dredging and disposal; military installation management; resource management; and development or modification of water quality standards. Notably, all categories of projected future actions that may trigger consultation because they have the potential to adversely affect the PCE also have the potential to adversely affect the corals themselves. There are no categories of activities that would trigger consultation on the basis of the proposed critical habitat designation alone. However, it is feasible that a specific future project within a category of activity would have impacts on critical habitat but not on the species. Because the total surface area covered by the proposed PCE (although unquantified) is far larger than the total surface area on which the corals (again unquantified) currently occur, it is likely there will be more consultations with impacts on critical habitat than on the species. Nonetheless, it was impossible to determine how many of those projects there may be over the 10-year horizon of our impacts analysis. To avoid underestimating impacts, we assumed that all of the projected future actions in these categories will require formal consultations for estimation of both administrative and project modification costs. This assumption likely results in an overestimation of the number of future formal consultations. We next considered the range of modifications we might seek for these activities to avoid adverse modification of elkhorn and staghorn coral critical habitat. We identified 13 potential project modifications that we may require to reduce impacts to the PCE through section 7 consultation under the ESA. To be conservative in estimating impacts, we assumed that project modifications would be required to address adverse effects from all projected future agency actions requiring consultation. Although we made the assumption that all potential project modifications would be required by NMFS, not all of the modifications identified for a specific category of activity would be necessary for an individual project, so we were unable to identify the exact modification or combinations of modifications that would be required for all future actions. We also identified whether a project modification would be required due to the listing of the species or another existing regulatory authority to determine if the cost of the project modification was likely to be co-extensive or incremental. Several project modifications (i.e., conditions monitoring, diver education, horizontal directional drilling (HDD), tunneling or anchoring cables and pipelines, sediment control measures, fishing gear maintenance, and water quality standard modification) were characterized as fully co-extensive with the listing of the species or other existing statutory or regulatory authority, because the nature of the actions that would require these modifications typically involve a large action area likely to include both the PCE and either the listed corals or other coral reef resources. Other project modifications (i.e., project relocation, diver assisted anchoring or mooring buoy use, global positioning system
(GPS)and dynamic positioning vessel
(DPV)protocol, sand bypassing/backpassing, shoreline protection measures, and use of upland or artificial sources of sand) were characterized as partially co-extensive with the listing of the species or other existing statutory or regulatory authority such as the Clean Water Act because of the typically smaller action area of projects that would involve these modifications, and thus the greater likelihood that specific projects would impact only the PCE. We did not identify any project modification that we expected would result in fully incremental costs due to the critical habitat designation. Table 1 provides a summary of the estimated costs, where possible, of individual project modifications. The Draft ESA 4(b)(2) Report provides a detailed description of each project modification, methods of determining estimated costs, and actions for which it may be prescribed. Although we have a projection of the number of future formal consultations (albeit an overestimation), the lack of information on specific project designs limits our ability to forecast the exact type and amount of modifications required. Thus, while the costs associated with types of project modifications were characterized, no total cost of this proposed rule could be quantified. Table 1.—Summary of Potential Per-Project Costs Associated With Specific Project Modifications—Where Information Was Available, Ranges of Scopes Are Included Project modification Cost Unit Range Approximate per project total Fully Co-extensive: Conditions Monitoring $3.5-6K per day 1-400 days $3.5K-2.4M. Diver Education Admin. Cost n/a n/a n/a. HDD/Tunneling $1.4-2.4M per mile 0.2-31.5 miles $278K-76.9M. Pipe Collars or Cable Anchors $1.2K per anchor 13-2,529 anchors $15.6K-3M. Sediment Controls $43K per mile 0.05-7 miles $2-301K. Water Quality Standard Modification Undeterminable n/a n/a n/a. Partially Co-extensive: Project Relocation Undeterminable n/a n/a n/a. Diver-assisted Anchoring or Mooring Buoy Use $300-1,000 per day n/a n/a. GPS & DPV protocol Undeterminable n/a n/a n/a. Sand Bypassing or Backpassing $1.5-16K per cu yd 75-512K cu yd $113K-8.2M. Shoreline Protection Measures Undeterminable n/a n/a n/a. Upland or Artificial Sources of Sand Undeterminable n/a n/a n/a In addition to project modification costs, administrative costs of consultation will be incurred by Federal agencies and project permittees or grantees as a result of this designation. Estimates of the cost of an individual consultation were developed from a review and analysis of the consultation database, as previously discussed, and from the estimated ESA section 7 consultation costs identified in the Economic Analysis of Critical Habitat Designation for the Gulf Sturgeon (IEc, 2003) inflated to 2006 dollars (the 2007 inflation coefficient was not known at the time of drafting). Cost figures are based on an average level of effort for consultations of low or high complexity (based on NMFS and other Federal agency information), multiplied by the appropriate labor rates for NMFS and other Federal agency staff. Although the PCE occurs in greater abundance than the corals and thus the probability that a consultation would be required because of the critical habitat designation is higher than for the listing of corals, we were unable to estimate the number of consultations that may be required on the basis of critical habitat alone. Therefore, we present the estimated maximum incremental administrative costs as averaging $827,220 to $1,633,229, annually. National Security Impacts Previous critical habitat designations have recognized that impacts to national security result if a designation would trigger future ESA section 7 consultations because a proposed military activity “may affect” the physical or biological feature(s) essential to the listed species' conservation. Anticipated interference with mission-essential training or testing or unit readiness, either through delays caused by the consultation process or through expected requirements to modify the action to prevent adverse modification of critical habitat, has been identified as a negative impact of critical habitat designations. (See, e.g., Proposed Designation of Critical Habitat for the Pacific Coast Population of the Western Snowy Plover, 71 FR 34571, June 15, 2006, at 34583; and Proposed Designation of Critical Habitat for Southern Resident Killer Whales; 69 FR 75608, Dec. 17, 2004, at 75633.) Past designations have also recognized that whether national security impacts result from the designation depends on whether future consultations would be required under the jeopardy standard regardless of the critical habitat designation, and whether the critical habitat designation would add new burdens beyond those related to the jeopardy consultation. As discussed above, based on the past 10-year consultation history, it is likely that consultations with respect to activities on DOD facilities will be triggered as a result of the proposed critical habitat designation. Further, it is possible that some consultations will be due to the presence of the PCE alone, and that adverse modification of the PCE could result, thus requiring a reasonable and prudent alternative to the proposed DOD activity. On May 22, 2007, we sent a letter to DOD requesting information on national security impacts of the proposed critical habitat designation, and received a response from the Department of the Navy (Navy). Further discussions and correspondence identified Naval Air Station Key West (NASKW) as the only installation potentially affected by the critical habitat designation. NASKW resides solely within the Florida specific area of the proposed critical habitat (Area 1). No other DOD installations were identified as likely to be impacted by this proposed designation. The Navy identified several specific activities within NASKW and associated annexes that would be adversely impacted by requirements to modify the actions to avoid destroying or adversely modifying critical habitat. These activities include: military training and readiness; access to, management of, and maintenance of piers, harbors, and waterfront instrumentation; and support for refueling or docking of Federal vessels. The Navy considers nearshore areas to be under its control pursuant to its navigable servitude for purposes of national defense under the Submerged Lands Act (43 U.S.C. 1314). Additionally, the Navy states that NASKW and associated annexes (including bombing and strafing areas) provide training necessary to national security and identified the types of military activities that take place in the areas. The Navy concluded that critical habitat designation at NASKW would likely impact national security by diminishing military readiness through the requirement to consult on their activities within critical habitat in addition to the requirement to consult on the two listed corals. We discuss our exclusion analysis based on these national security impacts below. Other Relevant Impacts Past critical habitat designations have identified two broad categories of other relevant impacts: Conservation benefits, both to the species and to society as a result of designation, and impacts on governmental or private entities that are implementing existing management plans that provide benefits to the listed species. Our Draft Section 4(b)(2) Report discusses conservation benefits of designating the four specific areas to the corals, and the benefits of conserving the corals to society, in both ecological and economic metrics. As summarized in the Draft 4(b)(2) Report, elkhorn and staghorn corals currently provide a range of important uses and services to society. Because the features that form the basis of the critical habitat are essential to, and thus contribute to, successful conservation of the two listed corals, protection of critical habitat from destruction or adverse modification may, at minimum, prevent further loss of the benefits currently provided by the species. Moreover, because the PCE is essential to increasing the abundance of elkhorn and staghorn corals, its successful protection may actually contribute to an increase in the benefits of these species to society in the future. While we cannot quantify nor monetize the benefits, we believe they are not negligible and would be an incremental benefit of this designation. However, although the PCE is essential to the corals' conservation, critical habitat designation alone will not bring about their recovery. The benefits of conserving elkhorn and staghorn coral are, and will continue to be, the result of several laws and regulations. Elkhorn and staghorn corals are two of the major reef-building corals in the Caribbean. Over the last 5,000 years, they have made a major contribution to the structure that makes up the Caribbean reef system. The structural and ecological roles of Atlantic acroporids in the Caribbean are unique and cannot be filled by other reef-building corals in terms of accretion rates and the formation of structurally complex reefs. At current levels of acroporid abundance, this ecosystem function is significantly reduced. Due to elkhorn and staghorn corals' extremely reduced abundance, it is likely that Caribbean reefs are in an erosional, rather than accretional, state. In addition to the important functions of reef building and reef maintenance provided by elkhorn and staghorn corals, these species themselves serve as fish habitat (Ogden and Ehrlich, 1977; Appeldoorn, *et al.* , 1996), including essential fish habitat (CFMC, 1998), for species of economic and ecological importance. Specifically, Lirman
(1999)reported significantly higher abundances of grunts (Haemulidae), snappers (Lutjanidae), and sweepers (Pempheridae) in areas dominated by elkhorn coral compared to other coral sites suggesting that fish schools use elkhorn colonies preferentially. Additionally, Hill
(2001)found that staghorn coral in a Puerto Rican back-reef lagoon was the preferred settlement habitat for the white grunt *(Haemulon plumieri* ). Numerous reef studies have also described the relationship between increased habitat complexity and increased species richness, abundance, and diversity of fishes. Due to their branching morphologies, elkhorn and staghorn corals provide complexity to the coral reef habitat that other common species with mounding or plate morphologies do not provide. Another benefit of elkhorn and staghorn corals is provided in the form of shoreline protection. Again, due to their function as major reef building species, elkhorn and staghorn corals provide shoreline protection by dissipating the force of waves, which are a major source of erosion and loss of land (NOAA, 2005). For example, in 2005, the coast of Mexico north of Cancun was impacted by Hurricane Wilma; wave height recorded just offshore of the barrier reef was 11 m while wave height at the coast was observed to be 3 m (B. van Tussenbroek, pers. comm.). Damage to coastal structures would have been significantly greater had the 11-m waves not been dissipated by the reef. Lastly, numerous studies have identified the economic value of coral reefs to tourism and recreation. Of particular relevance, Johns, *et al.*
(2003)estimated the value of natural reefs to reef users, and the contribution of natural reefs to the economies of the four counties of Florida that are associated with the proposed designation (discussed below). The importance of the benefits elkhorn and staghorn corals provide is also evidenced by the designation of marine protected areas specifically for the protection of these species (e.g., Tres Palmas Reserve, Puerto Rico). Many previous designations have evaluated the impacts of designation on relationships with, or the efforts of, private and public entities that are involved in management or conservation efforts benefitting listed species. Similar to national security impacts, impacts on entities responsible for natural resource management or conservation plans that benefit listed species, or on the functioning of those plans, depend on the type and number of ESA section 7 consultations and potential project modifications that may result from the proposed critical habitat designation in the areas covered by the plans. Several existing resource management areas (Florida Keys National Marine Sanctuary, Dry Tortugas National Park, Dry Tortugas Ecological Reserve, Biscayne Bay National Park, Buck Island Reef National Monument, Virgin Islands National Park, and Virgin Islands Coral Reef National Monument) will likely require section 7 consultation in the future when the responsible Federal agencies revise their management plans or associated regulations or implement management actions. Negative impacts to these agencies could result if the designation interferes with their ability to provide for the conservation of the species or otherwise hampers management of these areas. Because we identified that resource management was a category of activities that may affect both the species and the critical habitat and that the project modifications required through section 7 consultation would be the same for the species and the PCE, these costs are considered to be coextensive. However, we found no evidence that relationships would be negatively affected or that negative impacts to other agencies' ability to provide for the conservation of the corals would result from the designation. We also describe in our draft 4(b)(2) report that the critical habitat designation will provide an important unique benefit to the corals by protecting settling substrate for future coral recruitment and recovery, compared to existing laws and management plans for these areas that focus on protecting existing coral resources. Synthesis of Impacts Within the Four Specific Areas As discussed above, no categories of Federal actions would require consultation in the future solely due to the critical habitat designation; all projected categories of future actions have the potential to adversely affect both the PCE and the listed corals. However, an individual action within these categories may ultimately result in impacts to only the PCE because the species may not be present within the action area. In addition, past actions triggered consultation due to effects on one or more other listed species within the areas covered by the proposed designation (e.g., sea turtles, smalltooth sawfish, Johnson's seagrass), but for purposes of the impacts analysis we assumed these other species consultations would not be co-extensive with consultations for the corals or the PCE. For each of the specific areas, whether future consultations are incremental impacts of the critical habitat designation or are co-extensive impacts of the listing or other legal authorities will depend on whether the listed corals or other coral species are in the action area. Based on the relative abundance of the PCE and the listed corals, or all corals combined, there seems to be a higher likelihood that a future project could impact the PCE alone and thus be an incremental impact of designation. On the other hand, projects with larger or diffuse action areas may have a greater likelihood of impacting both the PCE and the corals, and the same modifications would alleviate both types of impacts, so the costs of these projects would more likely be co-extensive either with the listing or existing authorities focused on protecting coral reef resources. The proposed Florida specific area of critical habitat (Area 1) will have the greatest number of ESA section 7 consultations resulting from the proposed critical habitat designation over the next 10 years, 317 consultations, or, on average, 31 per year; the Puerto Rico specific area (Area 2) will have the second highest number of consultations, 115, or, on average, 11-12 per year; and the U.S.V.I. specific areas combined (Areas 3 and 4) will have the lowest number of consultations, 41, or, on average, 4 per year. The number of future consultations is proportional to the length of coastline in each of the four specific areas: Area 1 is projected to experience 66 percent of total consultations and it contains 65 percent of critical habitat coastline; Area 2 is projected to have 25 percent of consultations and contains 26 percent of shoreline included in the designation; and Areas 3 and 4 are projected to have 9 percent of consultations and contain 8 percent of total shoreline. In all four specific areas USACE-permitted marine construction activities comprise the largest number of projected future actions, in similar percentages across the areas (75 percent in Area 1; 65 percent in Area 2; and 61 percent in Areas 3 and 4). We detected no patterns or clumping in the geographic distribution of projected future actions and future consultations and project modifications within any of the specific areas that would suggest an economic basis for focusing our evaluation of impacts on smaller areas within any of the areas. In other words, no particular areas within the specific areas identified are expected to incur a disproportionate share of the costs of designation. As mentioned above, the majority of projected ESA section 7 consultations in all four specific areas will be USACE-authorized marine construction activities, and all of these could involve third-party permittees. Although we assumed all of these projects will require formal consultation due to effects on the PCE and the corals to avoid underestimating ESA section 7 impacts, as discussed in our impacts report, it is unlikely that *all* of these projects will trigger consultation for either the PCE or the corals, or that they would require modification to avoid adverse impacts. Though our database on past consultations is not complete, the data indicate that the majority of the projects in this category were residential dock construction, and as such would have been located in protected shorelines such as manmade canals where the PCE and the corals are not routinely found. Even when these projects trigger consultation in the future, the project modifications that may be required as a result of the proposed critical habitat may also be required by an existing regulatory authority, including the ESA listing of the two corals. Thus, if both the PCE and corals are present, or if another regulatory authority would also require the project modification, the costs associated with these project modifications will be co-extensive. Many of the other categories of activities projected to occur in all four specific areas have the potential to have effects over larger, more diffuse action areas, and thus are more likely to be co-extensive costs of the designation (e.g., dredging projects, water discharge, and water quality regulatory projects). We estimated the maximum incremental administrative costs of conducting ESA section 7 consultation for each of the four specific areas. Multiplying the total number of consultations by the low and high estimates of cost yields the following ranges of total administrative costs (in 2006 dollars) per area over the next 10 years: $5,543,946 to $10,945,740 in Area 1; $2,011,211 to $3,970,852 in Area 2; and $717,040 to $1,415,695 in Areas 3 and 4. Table 1 above provides a summary of the estimated costs, where possible, of individual project modifications. The Draft Section 4(b)(2) Report provides a detailed description of each project modification, methods of determining estimated costs, and for which action(s) it may be prescribed. Although we have a projection of the number of future formal consultations (albeit an overestimation), the lack of information on the specifics of project design limits our ability to forecast the exact type and amount of modifications required. Therefore, while the costs associated with types of project modifications were characterized, no total cost of this proposed rule can be quantified accurately. Preventing these project impacts is expected to contribute to the preservation of, and potential increases in, economic and other conservation benefits in each of the four specific areas, as described in the Draft Section 4(b)(2) Report. In Area 1, the natural reefs formed and inhabited by elkhorn and staghorn corals provide over $225 million in average annual use value (2003 dollars) and a capitalized value of over $7 billion to the four Florida counties covered by Area 1. Natural reef-related industries provided over 40,000 jobs in Area 1 in 2003, generating over $1 billion in income. Area 1 experienced almost $6 million in value of commercial reef-dependent fish landings in 2005. Available information also demonstrates the direct link between healthy coral reef ecosystems and the value of scuba-diving related tourism throughout the Caribbean, including Florida, with estimated losses in the hundreds of millions of dollars region-wide per year if reef degradation continues. Coral reefs provided over 87 percent of average annual commercial fish and invertebrate landings in Puerto Rico (Area 2) from 1995 to 2002. In 2005, domestic landings of shallow water reef fish comprised about 66 percent of all fish landed in Puerto Rico and were valued at over $1.7 million. Tourism is not as important a component of Puerto Rico's overall economy as it is in Areas 1, 3, and 4, but it may be much more significant for the shoreside communities from which dive and other reef-related tourism activities embark. Tourism accounts for 80 percent of the U.S.V.I.'s (Area 3) Gross Domestic Product and employment. One survey documented that 100 percent of hotel industry respondents stated they believed there would be a significant impact on tourist visits if the coast and beaches were degraded, or fisheries or coral reefs declined. In 2005, domestic landings of shallow water reef fish comprised about 83 percent of all fish landed in the U.S.V.I. that year and were valued at over $3.8 million. Conservation benefits to the corals in each of the four specific areas are expected to result from the designation. As we have determined, recovery of elkhorn and staghorn corals cannot succeed without protection of the PCE from destruction or adverse modification. No existing laws or regulations protect the PCE from destruction or adverse modification with a specific focus on increasing coral abundance and eventual recovery. Given the extremely low current abundance of the corals and characteristics of their sexual reproduction (e.g., limited success over long ranges), protecting the PCE throughout the corals' range and throughout each of the four specific areas is extremely important for conservation of these species. We also describe the potential educational and awareness benefits to the corals that may result from the critical habitat designation in our Draft 4(b)(2) Report. Regarding economic impacts, the limitations to the type and amount of existing information do not allow us to predict the total costs and benefits of the proposed designation. Nevertheless, we believe that our characterization of the types of costs and benefits that may result from the designation, in particular circumstances, may provide some useful information to Federal action agencies and potential project permittees. We have based the proposed designation on a very specifically defined feature essential to the corals' conservation, which allowed us to identify the few, specific effects of human activities that may adversely affect the corals and thus require section 7 consultation under the ESA (sedimentation, nutrification, and physical destruction). We identified potential routine project modifications we may require to avoid destroying or adversely modifying the essential substrate feature. In some cases, these modifications are common environmental mitigation measures that are already being performed under existing laws and regulations that seek to prevent or minimize adverse impacts to coral reef or marine resources in general. Thus, we believe that parties planning future activities within the four specific areas proposed for designation will be able to predict the potential added costs of their projects resulting from the designation based on their knowledge of the location, size, and timing of their planned activities. We have discussed to the extent possible the circumstances under which section 7 impacts will be incremental impacts of this rule, or co-extensive impacts of this rule and the listing of the corals or another existing legal authority. We believe that the limitations of current information about potential future projects do not allow us to be more specific in our estimates of the section 7 impacts (administrative consultation and project modification costs) of the proposed designation. In addition, based on available information, we did not identify any patterns or clumping in the distribution of future projects (and the associated consultations and potential modifications) either between or within the four specific areas proposed for designation that would suggest any disproportionate impact of the designation. Similarly, with regard to the conservation benefits of the proposed designation, we determined that the designation will result in benefits to society. We provide a literature survey of the valuation of coral reefs to provide context for the readers on benefits of protective measures. Given the potential number and type of future ESA section 7 consultations, we expect that the designation will prevent adverse effects to the proposed critical habitat feature, and thus assist in maintaining the feature's conservation function for the two corals. We believe the designation will assist in preventing further losses of the corals and, eventually, in increased abundance of the two species. By contributing to the continued existence of these two species and eventually their increased abundance, the proposed designation will, at minimum, prevent loss of important societal benefits described above that are currently provided by the species, and potentially increase these benefits over time. Regarding impacts on Federal agencies responsible for managing resources in areas proposed for designation, we expect section 7 consultation responsibilities will result from the designation as described above. However, as explained further in the section 4(b)(2) report, we determined that the designation will not negatively impact the management or operation of existing managed areas or the Federal agencies responsible for these areas. We further determined that the designation provides an added conservation benefit to the corals beyond the benefits provided by the existing management plans and associated regulations. We believe our evaluation and consideration of the potential impacts above support our conclusion that there are no economic or other relevant impacts that warrant our proposing to exclude particular areas from the designation. Given the limitations on existing data and information, we are specifically requesting comments and information that may be useful in refining our analysis, including any omitted categories of activities that may affect the essential feature and more precise cost estimates for project modifications. As discussed in the next section, we are exercising our discretion to propose excluding particular areas from the critical habitat designation based on national security impacts. Proposed Exclusions Under Section 4(b)(2) Impacts to national security as a result of the proposed critical habitat designation are expected to occur in Area 1, specifically on 47.3 sq miles (123 sq km) of NASKW. Based on information provided to us by the Navy, national security interests would be negatively impacted by the designation, because the potential additional consultations and project modifications to avoid adversely modifying the PCE would interfere with military training and readiness. Based on these considerations, we propose exclusion of the particular areas identified by the Navy from the critical habitat designation. The benefit of excluding the NASKW particular areas is that the Navy would only be required to comply with the jeopardy prohibition of ESA section 7(a)(2) and not the adverse modification prohibition. The Navy maintains that the additional commitment of resources in completing an adverse modification analysis, and any change in its activities to avoid adverse modification of critical habitat, would likely reduce its readiness capability. Given that the Navy is currently actively engaged in training, maintaining, and deploying forces in the current war effort, this reduction in readiness could reduce the ability of the military to ensure national security. The best scientific and commercial data available indicate that the PCE is rare within the proposed exclusion area. Further, the area to be excluded comprises only 1.1 percent of Area 1. The corals and habitat will still be protected through ESA section 7 consultations that prohibit jeopardizing the species' continued existence and require modifications to minimize the impacts of incidental take. Further, there are no other Federal activities that might adversely impact the proposed critical habitat that would be exempted from future consultation requirements due to this proposed exclusion, since these areas are under exclusive military control. Therefore, in our judgment, the benefit of including the particular area of NASKW is outweighed by the national security benefit the Navy will gain by not consulting on critical habitat. Given the small percentage of Area 1 encompassed by this area, we conclude that exclusion will not result in extinction of either elkhorn or staghorn corals. Critical Habitat Designation We are proposing to designate approximately 4,931 square miles (12,569 sq km) of marine habitat within the geographical area occupied by elkhorn and staghorn corals in Florida, Puerto Rico, and the U.S.V.I. The proposed specific areas contain the substrate physical feature, or PCE, we determined to be essential to the conservation of these species and that may require special management considerations or protection. Public Comments Solicited We request that interested persons submit comments, information, maps, and suggestions concerning this proposed rule and supporting draft 4(b)(2) report during the comment period (see DATES ). We are soliciting comments or suggestions from the public, other concerned governments and agencies, the scientific community, industry, or any other interested party concerning this proposed rule. We are also soliciting comments on the draft 4(b)(2) report and its analysis of economic, national security, and other relevant impacts and proposed exclusions. You may submit your comments and materials concerning this proposal by any one of several methods (see ADDRESSES ). The proposed rule, maps, fact sheets, references, and other materials relating to this proposal can be found on the NMFS Southeast Region Web site at *http://sero.nmfs.noaa.gov/pr/protres.htm.* We will consider all comments pertaining to this designation received during the comment period in preparing the final rule. Accordingly, the final designation may differ from this proposal. Public Hearings 50 CFR 424.16(c)(3) requires the Secretary to promptly hold at least one public hearing if any person requests one within 45 days of publication of a proposed rule to designate critical habitat. Such hearings provide the opportunity for interested individuals and parties to give comments, exchange information and opinions, and engage in a constructive dialogue concerning this proposed rule. We encourage the public's involvement in these hearings. Based on the high level of public interest in elkhorn and staghorn corals, public meetings have been scheduled for: 1. Tuesday, March 4, 2008, 7 p.m. to 9 p.m., IGFA Events Hall, 300 Gulf Stream Way, Dania Beach, Florida. 2. Wednesday, March 5, 2008, 7 p.m. to 9 p.m., Marathon Government Center, 2798 Overseas Highway, Marathon, Florida. 3. Tuesday, March 11, 2008, 6 p.m. to 8 p.m., Administration and Conference Center (ACC), 1st Floor Conference Room, University of the Virgin Islands, #2 John Brewer's Bay, St. Thomas, U.S.V.I./Simulcast Location on St. Croix: The Great Hall, Room #134, University of the Virgin Islands, RR 1, Box 10000 Kingshill, St. Croix, U.S.V.I. 4. Wednesday, March 12, 2008, 7 p.m. to 9 p.m., 4th Floor Conference Room, Environmental Building, Cruz Matos, State Road #838, km 6.3, Sector El Cinco, Rio Piedras, Puerto Rico. Requests for additional public hearings must be made in writing (see ADDRESSES ) by March 24, 2008. Peer Review In December 2004, the Office of Management and Budget
(OMB)issued a Final Information Quality Bulletin for Peer Review establishing minimum peer review standards, a transparent process for public disclosure of peer review planning, and opportunities for public participation. The OMB Bulletin, implemented under the Information Quality Act (Pub. L. 106-554), is intended to enhance the quality and credibility of the Federal government's scientific information, and applies to influential or highly influential scientific information disseminated on or after June 16, 2005. To satisfy our requirements under the OMB Bulletin, we obtained independent peer review of the scientific information that supports this proposal to designate critical habitat for elkhorn and staghorn corals and incorporated the peer review comments prior to dissemination of this proposed rulemaking. A Draft 4(b)(2) Report (NMFS, 2007) that supports the proposal to designate critical habitat for elkhorn and staghorn corals was also peer reviewed and is available on our Web site (see ADDRESSES ). We determined that this action is consistent to the maximum extent practicable with the enforceable policies of the approved coastal management programs of Florida, Puerto Rico, and U.S.V.I. The determination has been submitted for review by the responsible state agencies under section 307 of the Coastal Zone Management Act. This proposed rule has been determined to be significant under Executive Order (E.O.) 12866. We have integrated the regulatory principles of the E.O. into the development of this proposed rule to the extent consistent with the mandatory duty to designate critical habitat, as defined in the ESA. We prepared an initial regulatory flexibility analysis
(IRFA)pursuant to section 603 of the Regulatory Flexibility Act (5 U.S.C. 601, *et seq.* ), which describes the economic impact this proposed rule, if adopted, would have on small entities. A description of the action, why it is being considered, and its legal basis are included in the preamble section of this proposed rule. Small businesses, small nonprofit organizations, and small governmental jurisdictions may be affected by this proposed designation if they engage in activities that would affect the essential feature identified in this proposed designation and if they receive funding or authorization for such activity from a Federal agency. Such activities would trigger ESA section 7 consultation requirements and potential requirements to modify proposed activities to avoid destroying or adversely modifying the critical habitat. The consultation record from which we have projected likely Federal actions over the next 10 years indicates that applicants for Federal permits or funds have included small entities. For example, marine contractors have been the recipients of USACE permits for dock construction; some of these contractors were small entities. According to the Small Business Administration, businesses in the Heavy and Civil Engineering Construction subsector (NAICS Code 237990), which includes firms involved in marine construction projects such as breakwater, dock, pier, jetty, seawall and harbor construction, must have average annual receipts of no more than $31 million to qualify as a small business (dredging contractors that perform at least 40 percent of the volume dredged with their own equipment, or equipment owned by another small concern are considered small businesses if their average annual receipts are less than or equal to $18.5 million). Our consultation database does not track the identity of past permit recipients or whether the recipients were small entities, so we have no basis to determine the percentage of grantees or permittees that may be small businesses in the future. We do know from the more recent consultation history that small governmental jurisdictions (population less than or equal to 50,000) have received USACE permits for beach renourishment. Small businesses in the tourist and commercial fishing industries may benefit from the rule, as conservation of elkhorn and staghorn corals is expected to result in increased direct and indirect use of, and values derived from, coral reefs. We encourage small businesses, small governmental jurisdictions, and other small entities to provide comment on whether they may be affected by this rulemaking to help us provide an accurate estimate of the number of small entities to which the proposed rule will apply. We projected that, on average, approximately 39 Federal projects with non-federal grantees or permittees will be affected by implementation of the proposed critical habitat designation, annually, across all four areas proposed for inclusion in the critical habitat designation. Some of these grantees or permittees could be small entities, or could hire small entities to assist in project implementation. Historically, these projects have involved pipeline installation and maintenance, mooring construction and maintenance, dock/pier construction and repair, marina construction, bridge repair and construction, new dredging, maintenance dredging, NPDES/water quality standards, cable installation, beach nourishment, shoreline stabilization, reef ball construction and installation, and port construction. Potential project modifications we have identified that may be required to prevent these types of projects from adversely modifying critical habitat include: project relocation; environmental conditions monitoring; GPS and DPV protocols; diver assisted anchoring or mooring buoy use; pipe collars or cable anchoring; shoreline protection measures; use of upland or artificial sources of sand; direction drilling or tunneling; and sediment and turbidity control measures (see Tables 20, 21 and 24 of the Draft Section 4(b)(2) Report). Even though we cannot determine relative numbers of small and large entities that may be affected by this proposed rule, there is no indication that affected project applicants would be limited to, nor disproportionately comprise, small entities. It is unclear whether small entities would be placed at a competitive disadvantage compared to large entities. However, as described in the Draft Section 4(b)(2) Report, consultations and project modifications will be required based on the type of permitted action and its associated impacts on the essential critical habitat feature. Because the costs of many potential project modifications that may be required to avoid adverse modification of critical habitat are unit costs (e.g., per mile of shoreline, per cubic yard of sand moved) such that total project modification costs would be proportional to the size of the project, it is not unreasonable to assume that larger entities would be involved in implementing the larger projects with proportionally larger project modification costs. It is also unclear whether the proposed rule will significantly reduce profits or revenue for small businesses. As discussed throughout the Draft Section 4(b)(2) Report, we made assumptions that all of the future consultations will be formal, and all will require project modifications; but this is likely an overestimation. In addition, as stated above, though it is not possible to determine the exact cost of any given project modification resulting from consultation, the smaller projects most likely to be undertaken by small entities would likely result in relatively small modification costs. Finally, many of the modifications identified to reduce the impact of a project on critical habitat may be a baseline requirement either due to the ESA listing of the species or under another regulatory authority, notably the Clean Water Act. There are no record-keeping requirements associated with the proposed rule. Similarly, there are no reporting requirements other than those that might be associated with reporting on the progress and success of implementing project modifications, which do not require specific skills to satisfy. However, third party applicants or permittees would be expected to incur costs associated with participating in the administrative process of consultation along with the permitting Federal agency. Such third party costs of consultation were estimated for the 2003 designation of critical habitat for Gulf sturgeon in the southeast United States. In 2006 dollars, per consultation administrative costs for third parties are estimated to average from $3,251 to $4,596. We encourage all small businesses, small governmental jurisdictions, and other small entities that may be affected by this rule to provide comment on the potential economic impacts of the proposed designation, such as anticipated costs of consultation and potential project modifications, to improve the above analysis. No Federal laws or regulations duplicate or conflict with the proposed rule. Existing Federal laws and regulations overlap with the proposed rule only to the extent that they provide protection to marine natural resources or corals generally. However, no existing laws or regulations specifically prohibit destruction or adverse modification of critical habitat for, and focus on the recovery of, elkhorn and staghorn corals. The alternatives to the proposed designation considered consisted of a no-action alternative and an alternative based on a broader conservation objective that would include multiple physical or biological features of the corals' environment in the designation. The no-action, or no designation, alternative would result in no additional ESA section 7 consultations relative to the status quo of the species' listing and finalization of a recently proposed ESA section 4(d) rule. However, while additional administrative and potential project modification costs would not be incurred under this alternative, this alternative is not necessarily a no cost alternative, including to small entities, given the potential loss of existing benefits provided by the corals if they continue to decline due to failure to protect the substrate PCE from adverse modification. The multiple features alternative was expected to increase the number and complexity of section 7 consultations and associated costs to small entities without concomitant increased conservation benefits to the corals, because we believe the additional features are already effectively managed through the jeopardy analysis required under ESA section 7 or subsumed within the substrate PCE identified for this designation. An environmental analysis as provided for under National Environmental Policy Act for critical habitat designations made pursuant to the ESA is not required. See *Douglas County* v. *Babbitt* , 48 F.3d 1495 (9th Cir. 1995), cert. denied, 116 S.Ct. 698 (1996). Pursuant to the Executive Order on Federalism, E.O. 13132, the Assistant Secretary for Legislative and Intergovernmental Affairs will provide notice of the proposed action and request comments from the appropriate official(s) of the states and territories in which the two species occur. The proposed action has undergone a pre-dissemination review and determined to be in compliance with applicable information quality guidelines implementing the Information Quality Act (Section 515 of Pub. L. 106-554). This action does not contain a collection-of-information requirement for purposes of the Paperwork Reduction Act. This proposed rule is consistent with E.O. 13089, which is intended to preserve and protect the biodiversity, health, heritage, and social and economic value of U.S. coral reef ecosystems and the marine environment. References Cited A complete list of all references cited in this rulemaking can be found on our Web site at *http://sero.nmfs.noaa.gov/pr/protres.htm* and is available upon request from the NMFS Southeast Regional Office in St. Petersburg, Florida (see ADDRESSES ). List of Subjects 50 CFR Part 223 Endangered and threatened species, Exports, Imports, Transporation. 50 CFR Part 226 Endangered and threatened species. Dated: January 31, 2008. Samuel D. Rauch, III, Deputy Assistant Administrator for Regulatory Programs, National Marine Fisheries Service. For the reasons set out in the preamble, we propose to amend 50 CFR parts 223 and 226 as set forth below: PART 223—THREATENED MARINE AND ANADROMOUS SPECIES 1. The authority citation for part 223 continues to read as follows: Authority: 16 U.S.C. 1531-1543; subpart B, § 223.201-202 issued under 16 U.S.C. 1361 *et seq.* ; 16 U.S.C. 5503(d) for § 223.206(d)(9). § 223.102 [Amended] 2. Amend § 223.102 by removing the text, “NA”, from the column labeled “Citation for Critical Habitat Designation” in paragraphs (d)(1) and (d)(2) and adding in its place the **Federal Register** citation for the final rule associated with this proposed rule. PART 226—DESIGNATED CRITICAL HABITAT 3. The authority citation of part 226 continues to read as follows: Authority: 16 U.S.C. 1533. 4. Add § 226.215, to read as follows: § 226.215 Critical habitat for Elkhorn (Acropora palmata) and Staghorn (A. cervicornis) Corals. Critical habitat is designated for both elkhorn and staghorn corals as described in this section. The textual descriptions of critical habitat in paragraphs
(b)and
(c)of this section are the definitive source for determining the critical habitat boundaries. The overview maps in paragraph
(d)of this section are provided for general guidance purposes only, and not as a definitive source for determining critical habitat boundaries.
(a)*Physical Feature Essential to the Conservation of Threatened Corals.* The physical feature essential to the conservation of elkhorn and staghorn corals is: substrate of suitable quality and availability, in water depths from mean high water to 30 m, to support larval settlement and recruitment, and reattachment of asexual fragments. “Substrate of suitable quality and availability” is defined as natural consolidated hardbottom or dead coral skeleton that is free from fleshy macroalgae cover and sediment cover.
(b)*Critical Habitat Areas.* Critical habitat includes one specific area of the Atlantic Ocean offshore of Palm Beach, Broward, Miami-Dade, and Monroe counties, Florida, and three specific areas of the Atlantic Ocean and Caribbean Sea offshore of the U.S. Territories of Puerto Rico and the U.S. Virgin Islands. The boundaries of each specific critical habitat area are described below. Generally, the seaward boundary is the 30-m depth contour and the shoreward boundary is the line of mean high water (MHW; see 33 CFR 329.12(a)). Within these boundaries, discrete areas of water deeper than 30 m are not included.
(1)*Florida Area:* The boundary for the Florida area begins at the MHW line at the north boundary of Palm Beach County at 26°58′13.5″ N; then due east to the point of intersection with the 30-m contour; then following the 30-m contour to 24°45′20.6″ N, 82°34′35.4″ W, the point of intersection with the Florida Key National Marine Sanctuary (FKNMS) boundary (see 15 CFR 922.161); then following the FKNMS boundary to the point of intersection with the COLREGS line (see 33 CFR 80.727, 730, 735, and 740) at 24°54′56.8″ N, 80°56′25.2″ W; then following the COLREGS line to a point of intersection on Long Key at 24°49′1.7″ N, 80°49′36.1″ W; then following the COLREGS line and MHW line returning to the beginning point. The Florida area also includes two shoal areas southwest of the Dry Tortugas bounded by the 30-m contour.
(2)*Puerto Rico Area:* All areas surrounding the islands of the Commonwealth of Puerto Rico, 30 m in depth and shallower, seaward of the COLREGS line (see 33 CFR 80.738).
(3)*St. Thomas/St. John Area:* All areas surrounding the islands of St. Thomas and St. John, U.S. Virgin Islands, and smaller surrounding islands, 30 m in depth and shallower.
(4)*St. Croix Area:* All areas surrounding the island of St. Croix, U.S. Virgin Islands, 30 m in depth and shallower.
(c)*Areas excluded from critical habitat on the basis of national security impacts.* Critical habitat does not include the following particular areas in the state of Florida:
(1)All waters surrounding Naval Air Station, Key West from the shoreline delimited by the line of mean high water to a distance of 46 m.
(2)All waters identified as naval restricted areas and danger zone at 33 CFR 334.610, as follows:
(i)All waters within 100 yards of the south shoreline of the Harry S. Truman Annex, beginning at a point on the shore at 24°32′45.3″ N, 81°47′51″ W; thence to a point 100 yards due south of the south end of Whitehead Street of 24°32′42.3″ N, 81°47′51″ W; thence extending westerly, paralleling the southerly shoreline of the Harry S. Truman Annex, to 24°32′37.6″ N, 81°48′32″ W, thence northerly to the shore at 24°32′41″ N, 81°48′31″ W.
(ii)All waters within 100 yards of the westerly shoreline of the Harry S. Truman Annex and all waters within a portion of the Truman Annex Harbor, as defined by a line beginning on the shore at 24°33′00″ N, 81°48′41.7″ W; thence to a point 100 yards due west at 24°33′00″ N, 81°48′45″ W; thence northerly, paralleling the westerly shoreline of the Harry S. Truman Annex, including a portion of the Truman Annex Harbor entrance, to 24°33′23″ N, 81°48′37″ W; thence southeasterly to the shore (sea wall) at 24°33′19.3″ N, 81°48′28.7″ W.
(iii)All waters within 100 yards of the U.S. Coast Guard Station and the westerly end of Trumbo Point Annex beginning at the shore at 24°33′47.6″ N, 81°47′55.6″ W; thence westerly to 24°33′48″ N, 81°48′00.9″ W; thence due south to 24°33′45.8″ N, 81°48′00.9″ W; thence westerly to 24°33′47″ N, 81°48′12″ W; thence northerly to 24°34′06.2″ N, 81°48′10″ W; thence easterly to a point joining the restricted area around Fleming Key at 24°34′03.3″ N, 81°47′55″ W.
(iv)Beginning at 24°34′03.3″ N, 81°47′55″ W; proceed northwesterly, maintaining a distance of 100 yards from the shoreline of Fleming Key, except for a clearance of approximately 400 yards across the mouth of Fleming Cove near the southwesterly end of Fleming Key, continue around Fleming Key to a point easterly of the southeast corner of Fleming Key at 24°34′00.8″ N, 81°47′37.5″ W; thence easterly to 24°33′57.6″ N, 81°47′20″ W; thence southerly to a point on the shore at 24°33′54.7″ N, 81°47′20.9″ W.
(v)All waters contiguous to the southwesterly shoreline of Boca Chica Key beginning at a point on the southwest shoreline at 24°33′24″ N, 81°42′30″ W; proceed due south 100 yards to 24°33′20.4″ N, 81°42′30″ W; thence, maintaining a distance of 100 yards from the shoreline, proceed westerly and northerly to 24°34′03″ N, 81°42′47″ W; thence due north to a point at the easterly end of the U.S. Highway 1 (Boca Chica Channel) bridge at 24°34′39″ N, 81°42′47″ W.
(vi)Danger zone. All waters within an area along the northeast side of the Naval Air Station on Boca Chica Key defined by a line beginning at 24°35.472′ N, 81°41.824′ W; thence proceed in a northerly direction to a point at 24°36.289′ N, 81°41.437′ W; thence proceed westerly to a point at 24°36.392′ N, 81°41.970′ W; thence to a point on shore at 24°35.698′ N, 81°41.981′ W.
(3)All waters contained within the area identified as the Fleming Key Drop Zone, as defined by a rectangle with bounding coordinate pairs of: 24°35′42.2″ N and 81°47′43.6″ W; 24°35′42.6″ N and 81°46′27.3″ W; 24°35′13.0″ N and 81°47′38.2″ W; and 24°35′13.3″ N and 81°46′27.2″ W.
(4)All waters identified as bombing and strafing target areas at 33 CFR 334.620(a)(2)(i) through (iii), as follows:
(i)A circular area immediately west of Marquesas Keys with a radius of two nautical miles having its center at 24°33.4′ and 82°10.9′, not to include land area and area within Marquesas Keys.
(ii)A circular area located directly west of Marquesas Keys with a radius of three statute miles having its center at 24°35.6′ and 82°11.6′, not to include land area within Marquesas Keys.
(iii)A circular area located west of Marquesas Keys with a radius of two nautical miles having its center at 24°34′30″ and 82°14′00″ .
(d)Overview maps of designated critical habitat for elkhorn and staghorn corals follow. BILLING CODE 3510-22-P EP06FE08.107 EP06FE08.108 EP06FE08.109 EP06FE08.110 EP06FE08.111 EP06FE08.112 EP06FE08.113 EP06FE08.114 [FR Doc. 08-497 Filed 1-31-08; 4:13pm]
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  • 14 CFR 39
  • 1 CFR 51
  • 14 CFR 97
  • 16 CFR 1633
  • 21 CFR 1312
  • 21 CFR 1308
  • 5 USC 601-612
  • 40 CFR 180
  • 40 CFR 178
  • 40 CFR 2
  • 40 CFR 180.586
  • Pub. L. 104-4
  • Pub. L. 104-113
  • 5 CFR 300
  • 33 CFR 100
  • Pub. L. 104-121
  • 44 USC 3501-3520
  • 2 USC 1531-1538
  • 42 USC 4321-4370f
  • 33 USC 1233
  • 33 CFR 165
  • Pub. L. 107-295
  • 40 CFR 81
  • 40 CFR 9
  • 42 USC 7501-7511f
  • 40 CFR 180.142(a)
  • 40 CFR 180.241(a)
  • 40 CFR 180.241(c)
  • 40 CFR 180.241
  • 40 CFR 180.185(d)
  • 40 CFR 180.185(a)
  • 40 CFR 180.353(a)
  • 40 CFR 180.1(g)
  • 40 CFR 180.204(a)
  • 40 CFR 180.204
  • 40 CFR 180.204(c)
  • 40 CFR 180.349(a)(1)
  • 40 CFR 180.6(a)(3)
  • 40 CFR 180.349(a)(2)
  • 40 CFR 180.349(a)
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Final rule; request for comments
C.F.R.§ 21.29
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U.S.C.§ 106
C.F.R.§ 39.19
U.S.C.§ 552
U.S.C.§ 553
U.S.C.§ 1193
U.S.C.§ 801
F. App'x293 F.3d 1338
F. Supp.240 F. Supp. 2d 1090
F. Supp.344 F. Supp. 108
Cites 131 · showing 12Cited by 0 across 0 sources
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