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Code · REGISTER · 2006-09-01 · Federal Aviation Administration, DOT · Rules and Regulations

Rules and Regulations. Final rule; request for comments

14,153 words·~64 min read·/register/2006/09/01/06-7313

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

BILLING CODE 3410-02-P DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2006-25703; Directorate Identifier 2006-SW-20-AD; Amendment 39-14747; AD 2006-17-51] RIN 2120-AA64 Airworthiness Directives; Agusta S.p.A. Model AB139 Helicopters AGENCY: Federal Aviation Administration, DOT. ACTION: Final rule; request for comments. SUMMARY: This document publishes in the **Federal Register** an amendment adopting Airworthiness Directive
(AD)2006-17-51, sent previously to all known U.S. owners and operators of Agusta S.p.A. (Agusta) Model AB139 helicopters by individual letters. This AD requires, before further flight and at specified intervals, certain visual inspections of each tailpipe assembly for a crack and for overheating. If you find areas of overheating, this AD also requires, before further flight, certain inspections for damage to the surrounding structure, outside of the cowling, and inside of each tailpipe assembly in certain areas. This AD also requires, before further flight, if you find a crack, replacing the tailpipe assembly with an airworthy tailpipe assembly. This AD is prompted by several reports of tailpipe assembly cracks. The actions specified by this AD are intended to prevent a fire due to the structure in the cowling area overheating, separation of a part of a tailpipe assembly, and subsequent loss of control of the helicopter. DATES: Effective September 18, 2006, to all persons except those persons to whom it was made immediately effective by Emergency AD 2006-17-51, issued on August 15, 2006, which contained the requirements of this amendment. Comments for inclusion in the Rules Docket must be received on or before October 31, 2006. ADDRESSES: Use one of the following addresses to submit comments on this AD: • DOT Docket Web site: Go to *http://dms.dot.gov* and follow the instructions for sending your comments electronically; • Government-wide rulemaking Web site: Go to *http://www.regulations.gov* and follow the instructions for sending your comments electronically; • Mail: Docket Management Facility; U.S. Department of Transportation, 400 Seventh Street, SW., Nassif Building, Room PL-401, Washington, DC 20590; • Fax:
(202)493-2251; or • Hand Delivery: Room PL-401 on the plaza level of the Nassif Building, 400 Seventh Street, SW., Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. You may get the service information identified in this AD from Agusta, 21017 Cascina Costa di Samarate
(VA)Italy, Via Giovanni Agusta 520, telephone 39
(0331)229111, fax 39
(0331)229605-222595. Examining the Docket You may examine the docket that contains the AD, any comments, and other information on the Internet at *http://dms.dot.gov,* or in person at the Docket Management System
(DMS)Docket Offices between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The Docket Office (telephone
(800)647-5227) is located on the plaza level of the Department of Transportation Nassif Building at the street address stated in the ADDRESSES section. Comments will be available in the AD docket shortly after the DMS receives them. FOR FURTHER INFORMATION CONTACT: Ed Cuevas, Aviation Safety Engineer, FAA, Rotorcraft Directorate, Safety Management Group, Fort Worth, Texas 76193-0111, telephone
(817)222-5355, fax
(817)222-5961. SUPPLEMENTARY INFORMATION: On August 15, 2006, the FAA issued Emergency AD 2006-17-51 for Agusta Model AB139 helicopters, which requires before further flight and at specified intervals, certain visual inspections of each tailpipe assembly for a crack and for overheating. If you find areas of overheating, the AD also requires, before further flight, certain inspections for damage to the surrounding structure, outside of the cowling, and inside of each tailpipe assembly in certain areas using a flashlight or a mirror and a flashlight depending on the location. The AD also requires, before further flight, if you find a crack, replacing the tailpipe assembly with an airworthy tailpipe assembly. That action was prompted by several reports of tailpipe assembly cracks. This condition, if not corrected, could result in a fire due to the structure in the cowling area overheating, separation of a part of a tailpipe assembly, and subsequent loss of control of the helicopter. The European Aviation Safety Agency
(EASA)notified us that an unsafe condition may exist on Agusta S.p.A. Model AB139 helicopters. EASA advises that the field has reported tailpipe assembly cracks. EASA also advises that this issue, if not corrected, could lead to overheating of the structure in the cowling area or separation of parts hence endangering the safety of helicopter flight. Agusta has issued Bollettino Tecnico No. 139-069, dated August 11, 2006 (BT), which describes procedures for a detailed visual inspection for cracks on the tailpipe. EASA classified this BT as mandatory and issued Emergency AD No. 2006-0242-E, dated August 11, 2006. This helicopter model is manufactured in Italy and is type certificated for operation in the United States under the provisions of 14 CFR 21.29 and the applicable bilateral agreement. Pursuant to the applicable bilateral agreement, EASA has kept the FAA informed of the situation described above. The FAA has examined the findings of EASA, 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. Since the unsafe condition described is likely to exist or develop on other Agusta Model AB139 helicopters of the same type design, the FAA issued Emergency AD 2006-17-51 to prevent a fire due to the structure in the cowling area overheating, separation of a part of a tailpipe assembly, and subsequent loss of control of the helicopter. The AD requires the following: • Before further flight, and thereafter at intervals not to exceed 25 hours time-in-service, access the rear areas of each tailpipe assembly by removing the rear cowling. • Visually inspect each tailpipe assembly inside the cowling for a crack. • Inspect the structure surrounding each tailpipe assembly for overheating. If you find areas of overheating, inspect for damage to the surrounding structure. • Inspect for overheating in the area of each tailpipe assembly outside the cowling. Inspect the internal part of each tailpipe assembly in the areas depicted in Areas A, Figure 1, of this AD for a crack: ○ Clean the end of each tailpipe assembly with a cloth. While applying slight pressure on it, inspect for a crack using a flashlight. ○ Inspect each tailpipe assembly toward the centerline of the helicopter for a crack using a flashlight. ○ Inspect each tailpipe assembly toward the outside of the helicopter for a crack using a mirror and a flashlight. • If you find a crack, before further flight, replace the tailpipe assembly with an airworthy tailpipe assembly. The short compliance time involved is required because the previously described critical unsafe condition can adversely affect the structural integrity of the helicopter. Inspecting the tail pipe assembly for a crack and for overheating are required before further flight. Also, if you find a crack, replacing the tail pipe assembly with an airworthy tail pipe assembly is required before further flight. Therefore, this AD must be issued immediately. Since it was found that immediate corrective action was required, notice and opportunity for prior public comment thereon were impracticable and contrary to the public interest, and good cause existed to make the AD effective immediately by individual letters issued on August 15, 2006, to all known U.S. owners and operators of Agusta Model AB139 helicopters. These conditions still exist, and the AD is hereby published in the **Federal Register** as an amendment to 14 CFR 39.13 to make it effective to all persons. The FAA estimates that this AD will affect 16 helicopters of U.S. registry. It will take about 1 work hour to inspect each helicopter and 3 work hours to replace each tail pipe assembly at an average labor rate of $80 per work hour. Required parts will cost about $20,649 per tail pipe assembly. Based on these figures, we estimate the total cost impact of the AD on U.S. operators to be $366,224, assuming an initial and 24 repetitive inspections on each helicopter and replacing both tailpipe assemblies on half of the fleet (16 tail pipe assemblies). Comments Invited This AD is a final rule that involves requirements that affect flight safety and was not preceded by notice and an opportunity for public comment; however, we invite you to submit any written data, views, or arguments regarding this AD. Send your comments to an address listed under ADDRESSES . Include “Docket No. FAA-2006-25703; Directorate Identifier 2006-SW-20-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of the AD. We will consider all comments received by the closing date and may amend the AD in light of those comments. We will post all comments we receive, without change, to *http://dms.dot.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 our docket Web site, you can find and read the comments to any of our dockets, including the name of the individual who sent the comment. You may review the DOT's complete Privacy Act Statement in the **Federal Register** published on April 11, 2000 (65 FR 19477-78), or you may visit *http://dms.dot.gov.* 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 the regulation: 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 an economic evaluation of the estimated costs to comply with this AD. See the DMS to examine the economic evaluation. 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. List of Subjects in 14 CFR Part 39 Air transportation, Aircraft, Aviation safety, Safety. Adoption of the Amendment Accordingly, pursuant to 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. Section 39.13 is amended by adding a new airworthiness directive to read as follows: **2006-17-51 Agusta S.p.A.:** Amendment 39-14747. Docket No. FAA-2006-25703; Directorate Identifier 2006-SW-20-AD. *Applicability:* Model AB139 helicopters, with tailpipe assembly left hand, part number (P/N) 3G7800L00131 and right hand, P/N 3G7800L00231, installed, certificated in any category. *Compliance:* Required as indicated, unless accomplished previously. To prevent a fire due to the structure in the cowling area overheating, separation of part of each tailpipe assembly, and subsequent loss of control of the helicopter, do the following:
(a)Before further flight, and thereafter at intervals not to exceed 25 hours time-in-service, access the rear areas of each tailpipe assembly by removing the rear cowlings.
(1)Visually inspect each tailpipe assembly inside the cowling for a crack. Note 1: Bollettino Tecnico No. 139-069, dated August 11, 2006 (BT), pertains to the subject of this AD. Note 2: Aircraft Maintenance Publication
(AMP)AB139 pertains to the subject of this AD.
(2)Inspect the structure surrounding each tailpipe assembly for overheating. If you find areas of overheating, inspect for heat damage to the surrounding structure. Inspect for overheating in the area of each tailpipe assembly outside the cowling. Inspect the internal part of each tailpipe assembly in the areas depicted in Areas A, Figure 1, of this AD. ER01SE06.042
(i)Clean the end of each tailpipe assembly with a cloth. While applying slight pressure on it, inspect for a crack using a flashlight.
(ii)Inspect each tailpipe assembly toward the centerline of the helicopter for a crack using a flashlight.
(iii)Inspect each tailpipe assembly toward the outboard side of the helicopter for a crack using a mirror and a flashlight.
(3)If you find a crack, before further flight, replace the tailpipe assembly with an airworthy tailpipe assembly.
(b)To request a different method of compliance or a different compliance time for this AD, follow the procedures in 14 CFR 39.19. Contact the Manager, Safety Management Group, FAA, ATTN: Ed Cuevas, Aviation Safety Engineer, Fort Worth, Texas 76193-0111, telephone
(817)222-5355, fax
(817)222-5961, for information about previously approved alternative methods of compliance. Note 3: The subject of this AD is addressed in the European Aviation Safety Agency
(EASA)AD 2006-0242-E, dated August 11, 2006. Note 4: This AD differs from the BT and the EASA AD in that the BT and EASA AD allow repairs of certain cracks in each tailpipe assembly.
(c)This amendment becomes effective on September 18, 2006, to all persons except those persons to whom it was made immediately effective by Emergency AD 2006-17-51 issued August 15, 2006, which contained the requirements of this amendment. Issued in Fort Worth, Texas, on August 24, 2006. David A. Downey, Manager, Rotorcraft Directorate, Aircraft Certification Service. [FR Doc. E6-14548 Filed 8-31-06; 8:45 am] BILLING CODE 4910-13-P DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2006-25724; Directorate Identifier 2006-NM-197-AD; Amendment 39-14742; AD 2006-18-04] RIN 2120-AA64 Airworthiness Directives; Bombardier Model CL-600-2B16 (CL-604) Airplanes and Model CL-600-2B19 (Regional Jet Series 100 & 440) Airplanes AGENCY: Federal Aviation Administration (FAA), Department of Transportation (DOT). ACTION: Final rule; request for comments. SUMMARY: The FAA is adopting a new airworthiness directive
(AD)for certain Bombardier Model CL-600-2B16 (CL- 604) airplanes and Model CL-600-2B19 (Regional Jet Series 100 & 440) airplanes. These models may be referred to by their marketing designations as RJ100, RJ200, CRJ100, CRJ200, and CL-65. This AD requires revising the Emergency Procedures section of the airplane flight manual
(AFM)to advise the flightcrew of additional procedures to follow in the event of stabilizer trim runaway. For certain airplanes, this AD also requires revising the Abnormal Procedures section of the AFM to advise the flightcrew of procedures to follow in the event of MACH TRIM, STAB TRIM, and horizontal stabilizer trim malfunctions. This AD results from reports of uncommanded horizontal stabilizer trim motion. We are issuing this AD to ensure that the flightcrew is advised of appropriate procedures to follow in the event of stabilizer trim runaway. Failure to follow these procedures could result in excessive uncommanded movement of the horizontal stabilizer trim actuator
(HSTA)and loss of ability to use trim switches to override uncommanded movement or yoke disconnect switches to disconnect the HSTA, which could result in reduction of or loss of pitch trim control and consequent reduced controllability of the airplane. DATES: This AD becomes effective September 1, 2006. The Director of the Federal Register approved the incorporation by reference of certain publications listed in the AD as of September 1, 2006. We must receive comments on this AD by October 31, 2006. ADDRESSES: Use one of the following addresses to submit comments on this AD. • *DOT Docket Web site:* Go to *http://dms.dot.gov* and follow the instructions for sending your comments electronically. • *Government-wide rulemaking Web site:* Go to *http://www.regulations.gov* and follow the instructions for sending your comments electronically. • *Mail:* Docket Management Facility; U.S. Department of Transportation, 400 Seventh Street, SW., Nassif Building, Room PL-401, Washington, DC 20590. • *Fax:*
(202)493-2251. • *Hand Delivery:* Room PL-401 on the plaza level of the Nassif Building, 400 Seventh Street SW., Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. Contact Bombardier, Inc., Canadair, Aerospace Group, P.O. Box 6087, Station Centre-ville, Montreal, Quebec H3C 3G9, Canada, for service information identified in this AD. FOR FURTHER INFORMATION CONTACT: Bruce Valentine, Aerospace Engineer, Systems and Flight Test Branch, ANE-172, FAA, New York Aircraft Certification Office, 1600 Stewart Avenue, suite 410, Westbury, New York 11590; telephone
(516)228-7328; fax
(516)794-5531. SUPPLEMENTARY INFORMATION: Discussion Transport Canada Civil Aviation (TCCA), which is the airworthiness authority for Canada, notified us that an unsafe condition may exist on certain Bombardier Model CL-600-2B16 (CL-604) airplanes and Model CL-600-2B19 (Regional Jet Series 100 & 440) airplanes. TCAA advises that there have been reports of uncommanded horizontal stabilizer trim motion on Model CL-600-2B16 (CL-604) airplanes. Investigation revealed contamination of the circuit board of the horizontal stabilizer trim control unit (HSTCU). The circuit boards installed on HSTCUs were not conformal coated to protect against moisture exposure. Contamination of the circuit board could lead to one or more of the following types of behavior: • Erratic/intermittent uncommanded movement of the horizontal stabilizer trim actuator (HSTA). • Uncommanded movement of the HSTA to the full up or full down position. • Loss of the flightcrew's ability to override uncommanded movement by use of the trim switches. • Loss of the flightcrew's ability to disconnect the HSTA using the yoke disconnect switches. These conditions, if not corrected, could result in reduction of or loss of pitch trim control and consequent reduced controllability of the airplane. The HSTCU circuit boards on Model CL-600-2B19 (Regional Jet Series 100 & 440) airplanes are identical to that on the affected Model CL-600-2B16 (CL-604) airplanes. Therefore, those Model CL-600-2B19 (Regional Jet Series 100 & 440) airplanes may be subject to the unsafe condition revealed on the Model CL-600-2B16 (CL-604) airplanes. Relevant Service Information Canadair (Bombardier) has issued the temporary revisions
(TRs)specified in the table below. Table—TRs For Bombardier model— Use— Dated— To the— CL-600-2B16 (CL-604) airplanes Canadair Challenger TR 604/21 August 1, 2006 Canadair Challenger CL-604 AFM, PSP 604-1. CL-600-2B19 (Regional Jet Series 100 & 440) airplanes Canadair Regional Jet TR RJ/152-4 August 9, 2006 Canadair Regional Jet AFM, CSP A-012. TR 604/21 describes revising the Emergency Procedures section of the airplane flight manual
(AFM)to advise the flightcrew of additional procedures to follow in the event of stabilizer trim runaway. TR RJ/152-4 describes revising the Emergency and Abnormal Procedures sections of the AFM to advise the flightcrew of additional procedures to follow in the event of stabilizer trim runaway and to advise the flightcrew of procedures to follow in the event of MACH TRIM, STAB TRIM, and horizontal stabilizer trim malfunctions. TCCA mandated the service information and issued Canadian airworthiness directives CF-2006-20, dated August 22, 2006, and CF-2006-21, dated August 23, 2006, to ensure the continued airworthiness of these airplanes in Canada. FAA's Determination and Requirements of This AD These airplane models are manufactured in Canada and are 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. Pursuant to this bilateral airworthiness agreement, TCCA has kept the FAA informed of the situation described above. We have examined TCCA's findings, evaluated all pertinent information, and determined that we need to issue an AD for products of this type design that are certificated for operation in the United States. Therefore, we are issuing this AD to ensure that the flightcrew is advised of appropriate procedures to follow in the event of stabilizer trim runaway. Failure to follow these procedures could result in excessive uncommanded movement of the HSTA and loss of ability to use trim switches to override uncommanded movement or yoke disconnect switches to disconnect the HSTA, which could result in reduction of or loss of pitch trim control and consequent reduced controllability of the airplane. This AD requires revising the Emergency and Abnormal Procedures sections, as applicable, of the AFM to advise the flightcrew of additional procedures to follow in the event of stabilizer trim runaway. This AD follows the Canadian airworthiness directives referred to previously and adopts the same requirements. Interim Action We consider this AD interim action. The manufacturer is currently developing service bulletins that specify replacing HSTCU circuit boards with HSTCU circuit boards having conformal coating and is exploring other interim measures that will address the identified unsafe condition specified in this AD. Once new service information is developed, approved, and available, we may consider additional rulemaking. FAA's Determination of the Effective Date An unsafe condition exists that requires the immediate adoption of this AD; therefore, providing notice and opportunity for public comment before the AD is issued is impracticable, and good cause exists to make this AD effective in less than 30 days. Comments Invited This AD is a final rule that involves requirements that affect flight safety and was not preceded by notice and an opportunity for public comment; however, we invite you to submit any relevant written data, views, or arguments regarding this AD. Send your comments to an address listed in the ADDRESSES section. Include “Docket No. FAA-2006-25724; Directorate Identifier 2006-NM-197-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of the AD that might suggest a need to modify it. We will post all comments we receive, without change, to *http://dms.dot.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 that 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), or you may visit *http://dms.dot.gov.* Examining the Docket You may examine the AD docket on the Internet at *http://dms.dot.gov,* or in person at the Docket Management Facility office between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The Docket Management Facility office (telephone
(800)647-5227) is located on the plaza level of the Nassif Building at the DOT street address stated in the ADDRESSES section. Comments will be available in the AD docket shortly after the Docket Management System receives them. 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 the regulation: 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 regulatory evaluation of the estimated costs to comply with this AD and placed it in the AD docket. See the ADDRESSES section for a location to examine the regulatory evaluation. List of Subjects in 14 CFR Part 39 Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety. Adoption of the Amendment Accordingly, under the authority delegated to me by the Administrator, the FAA amends 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 Federal Aviation Administration
(FAA)amends § 39.13 by adding the following new airworthiness directive (AD): **2006-18-04 Bombardier, Inc. (Formerly Canadair):** Amendment 39-14742. Docket No. FAA-2006-25724; Directorate Identifier 2006-NM-197-AD. Effective Date
(a)This AD becomes effective September 1, 2006. Affected ADs
(b)None. Applicability
(c)This AD applies to Bombardier Model CL-600-2B16 (CL-604) airplanes, serial numbers 5301 and subsequent; and Model CL-600-2B19 (Regional Jet Series 100 & 440) airplanes, serial numbers 7003 through 7990 inclusive and 8000 and subsequent; certificated in any category. Note 1: The Model CL-600-2B19 (Regional Jet Series 100 & 440) airplanes may be referred to by their marketing designations as RJ100, RJ200, CRJ100, CRJ200, and CL-65. Unsafe Condition
(d)This AD results from reports of uncommanded horizontal stabilizer trim motion. We are issuing this AD to ensure that the flightcrew is advised of appropriate procedures to follow in the event of stabilizer trim runaway. Failure to follow these procedures could result in excessive uncommanded movement of the horizontal stabilizer trim actuator
(HSTA)and loss of ability to use trim switches to override uncommanded movement or yoke disconnect switches to disconnect the HSTA, which could result in reduction of or loss of pitch trim control and consequent reduced controllability of 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. Airplane Flight Manual
(AFM)Revision
(f)Within 7 days after the effective date of this AD, make the applicable AFM revisions specified in paragraph (f)(1) or (f)(2) of this AD by incorporating the applicable Canadair (Bombardier) temporary revisions
(TRs)identified in Table 1 of this AD into the applicable AFM.
(1)For Model CL-600-2B16 (CL-604) airplanes: Revise the Emergency Procedures section of the AFM to advise the flightcrew of additional procedures to follow in the event of stabilizer trim runaway.
(2)For Model CL-600-2B19 (Regional Jet Series 100 & 440) airplanes: Revise the Emergency and Abnormal Procedures sections of the AFM to advise the flightcrew of additional procedures to follow in the event of stabilizer trim runaway and in the event of MACH TRIM, STAB TRIM, and horizontal stabilizer trim malfunctions. Table 1.—TRs For Bombardier Model— Use— Dated— To the— CL-600-2B16 (CL-604) airplanes Canadair Challenger TR 604/21 August 1, 2006 Canadair Challenger CL-604 AFM, PSP 604-1. CL-600-2B19 (Regional Jet Series 100 & 440) airplanes Canadair Regional Jet TR RJ/152-4 August 9, 2006 Canadair Regional Jet AFM, CSP A-012.
(g)When the applicable TR has been included in the general revisions of the applicable AFM, those general revisions may be inserted into the AFM and the applicable TR may be removed, provided the relevant information in the general revisions is identical to that in the TR. Alternative Methods of Compliance (AMOCs) (h)(1) The Manager, New York Aircraft Certification Office, FAA, has the authority to approve AMOCs for this AD, if requested in accordance with the procedures found in 14 CFR 39.19.
(2)Before using any AMOC approved in accordance with § 39.19 on any airplane to which the AMOC applies, notify the appropriate principal inspector in the FAA Flight Standards Certificate Holding District Office. Related Information
(i)Canadian airworthiness directives CF-2006-20, dated August 22, 2006, and CF-2006-21, dated August 23, 2006, also address the subject of this AD. Material Incorporated by Reference
(j)You must use the applicable service information specified in Table 2 of this AD to perform the actions that are required by this AD, unless the AD specifies otherwise. The Director of the Federal Register approved the incorporation by reference of these documents in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Contact Bombardier, Inc., Canadair, Aerospace Group, P.O. Box 6087, Station Centre-ville, Montreal, Quebec H3C 3G9, Canada, for a copy of this service information. You may review copies at the Docket Management Facility, U.S. Department of Transportation, 400 Seventh Street SW., Room PL-401, Nassif Building, Washington, DC; on the Internet at *http://dms.dot.gov* ; or at the National Archives and Records Administration (NARA). For information on the availability of this material at the NARA, call
(202)741-6030, or go to *http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html* . Table 2.—Temporary Revisions Incorporated by Reference Temporary revision Dated— To the— Canadair Challenger Temporary Revision 604/21 August 1, 2006 Canadair Challenger CL-604 Airplane Flight Manual, PSP 604-1. Canadair Regional Jet Temporary Revision RJ/152-4 August 9, 2006 Canadair Regional Jet Airplane Flight Manual, CSP A-012. Issued in Renton, Washington, on August 29, 2006. Ali Bahrami, Manager, Transport Airplane Directorate, Aircraft Certification Service. [FR Doc. E6-14617 Filed 8-31-06; 8:45 am] BILLING CODE 4910-13-P DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 71 [Docket No. 29334; Amendment No. 71-38] Airspace Designations; Incorporation by Reference AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Final rule. SUMMARY: This action amends Title 14 Code of Federal Regulations (14 CFR) part 71 relating to airspace designations to reflect the approval by the Director of the **Federal Register** of the incorporation by reference of FAA Order 7400.9P, Airspace Designations and Reporting Points. This action also explains the procedures the FAA will use to amend the listings of Class A, B, C, D, and E airspace areas; air traffic service routes; and reporting points incorporated by reference. DATES: *Effective Date:* These regulations are effective September 15, 2006, through September 15, 2007. The incorporation by reference of FAA Order 7400.9P is approved by the Director of the Federal Register as of September 15, 2006, through September 15, 2007. FOR FURTHER INFORMATION CONTACT: Tameka Bentley, Airspace and Rules, Office of System Operations Airspace and AIM, Federal Aviation Administration, 800 Independence Avenue, SW., Washington, DC 20591; telephone:
(202)267-8783. SUPPLEMENTARY INFORMATION: History FAA Order 7400.9N, Airspace Designations and Reporting Points, dated September 1, 2005, and effective September 15, 2005, listed Class A, B, C, D and E airspace areas; air traffic service routes; and reporting points. Due to the length of these descriptions, the FAA requested approval from the Office of the Federal Register to incorporate the material by reference in the Federal Aviation Regulations § 71.1, effective September 15, 2005, through September 15, 2006. During the incorporation by reference period, the FAA processed all proposed changes of the airspace listings in FAA Order 7400.9N in full text as proposed rule documents in the **Federal Register** . Likewise, all amendments of these listings were published in full text as final rules in the **Federal Register** . This rule reflects the periodic integration of these final rule amendments into a revised edition of Order 7400.9P, Airspace Designations and Reporting Points. The Director of the Federal Register has approved the incorporation by reference of FAA Order 7400.9P in § 71.1, as of September 15, 2006, through September 15, 2007. This rule also explains the procedures the FAA will use to amend the airspace designations incorporated by reference in part 71. Sections 71.5, 71.15, 71.31, 71.33, 71.41, 71.51, 71.61, 71.71, and 71.901 are also updated to reflect the incorporation by reference of FAA Order 7400.9P. The Rule This action amends Title 14 Code of Federal Regulations (14 CFR) part 71 to reflect the approval by the Director of the Federal Register of the incorporation by reference of FAA Order 7400.9P, effective September 15, 2006, through September 15, 2007. During the incorporation by reference period, the FAA will continue to process all proposed changes of the airspace listings in FAA Order 7400.9P in full text as proposed rule documents in the **Federal Register** . Likewise, all amendments of these listings will be published in full text as final rules in the **Federal Register** . The FAA will periodically integrate all final rule amendments into a revised edition of the order, and submit the revised edition to the Director of the Federal Register for approval for incorporation by reference in section 71.1. The FAA has determined that this action:
(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. This action neither places any new restrictions or requirements on the public, nor changes the dimensions or operation requirements of the airspace listings incorporated by reference in part 71. Consequently, notice and public procedure under 5 U.S.C. 553(b) are unnecessary. Because this action will continue to update the changes to the airspace designations, which are depicted on aeronautical charts, and to avoid any unnecessary pilot confusion, I find that good cause exists, under 5 U.S.C. 553(d), for making this amendment effective in less than 30 days. List of Subjects in 14 CFR Part 71 Airspace, Incorporation by reference, Navigation (air). Adoption of the Amendment In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 71 as follows: PART 71—DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR TRAFFIC SERVICE ROUTES; AND REPORTING POINTS 1. The authority citation for part 71 continues to read as follows: Authority: 49 U.S.C. 106(g), 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389. 2. Section 71.1 is revised to read as follows: § 71.1 Applicability. The complete listing for all Class A, B, C, D, and E airspace areas; air traffic service routes; and reporting points can be found in FAA Order 7400.9P, Airspace Designations and Reporting Points, dated September 1, 2006. This incorporation by reference was approved by the Director of the Federal Register in accordance with 5 U.S.C. 552
(a)and 1 CFR part 51. The approval to incorporate by reference FAA Order 7400.9P is effective September 15, 2006, through September 15, 2007. During the incorporation by reference period, proposed changes to the listings of Class A, B, C, D, and E airspace areas; air traffic service routes; and reporting points will be published in full text as proposed rule documents in the **Federal Register** . Amendments to the listings of Class A, B, C, D, and E airspace areas; air traffic service routes; and reporting points will be published in full text as final rules in the **Federal Register** . Periodically, the final rule amendments will be integrated into a revised edition of the Order and submitted to the Director of the Federal Register for approval for incorporation by reference in this section. Copies of FAA Order 7400.9P may be obtained from the Law Library, Office of the Chief Counsel, Federal Aviation Administration, 800 Independence Avenue, SW., Washington, DC 20591,
(202)267-3174. An electronic version of the Order is available on the FAA Web site at *http://www.faa.gov/ATPUBS.* Copies of FAA Order 7400.9P may be inspected in Docket No. 29334, at the same address above, weekdays between 8 a.m. and 4:30 p.m., or on the **Federal Register** Web site at *www.regulations.gov* . § 71.5 [Amended] 3A. Section 71.5 is amended by removing the words “FAA Order 7400.9N” and adding,in their place, the words “FAA Order 7400.9P.” § 71.15 [Amended] 3B. Section 71.5 is amended by removing the words “FAA Order 7400.9N” and adding, in their place, the words “FAA Order 7400.9P.” § 71.31 [Amended] 4. Section 71.31 is amended by removing the words “FAA Order 7400.9N” and adding, in their place, the words “FAA Order 7400.9P.” § 71.33 [Amended] 5. Paragraph
(c)of section 71.33 is amended by removing the words “FAA Order 7400.9N” and adding, in their place, the words “FAA Order 7400.9P.” § 71.41 [Amended] 6. Section 71.41 is amended by removing the words “FAA Order 7400.9N” and adding, in their place, the words “FAA Order 7400.9P.” § 71.51 [Amended] 7. Section 71.51 is amended by removing the words “FAA Order 7400.9N” and adding, in their place, the words “FAA Order 7400.9P.” § 71.61 [Amended] 8. Section 71.61 is amended by removing the words “FAA Order 7400.9N” and adding, in their place, the words “FAA Order 7400.9P.” § 71.71 [Amended] 9. Paragraph (b), (c), (d), (e), and
(f)of section 71.71 are amended by removing the words “FAA Order 7400.9N” and adding, in their place, the words “FAA Order 7400.9P.” § 71.901 [Amended] 10. Paragraph
(a)of section 71.901 is amended by removing the words “FAA Order 7400.9N” and adding, in their place, the words “FAA Order 7400.9P.” Issued in Washington, DC, on July 27, 2006. Edith V. Parish, Manager, Airspace and Rules. [FR Doc. E6-12434 Filed 8-31-06; 8:45 am] BILLING CODE 4910-13-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 520 Oral Dosage Form New Animal Drugs; Carprofen AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration
(FDA)is amending the animal drug regulations to reflect approval of a supplemental abbreviated new animal drug application (ANADA) filed by IMPAX Laboratories, Inc. The supplemental ANADA provides for veterinary prescription use of carprofen caplets in dogs for the control of postoperative pain associated with soft tissue and orthopedic surgeries. DATES: This rule is effective September 1, 2006. FOR FURTHER INFORMATION CONTACT: John K. Harshman, Center for Veterinary Medicine (HFV-104), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-276-9808, e-mail: *john.harshman@fda.hhs.gov* . SUPPLEMENTARY INFORMATION: IMPAX Laboratories, Inc., 30831 Huntwood Ave., Hayward, CA 94544, filed a supplement to ANADA 200-366 for NOVOX (carprofen) caplets which are approved for veterinary prescription use in dogs for the relief of pain and inflammation associated with osteoarthritis (70 FR 30625, May 27, 2005). The supplement provides for use of NOVOX caplets for the control of postoperative pain associated with soft tissue and orthopedic surgeries. The supplemental ANADA is approved as of July 27, 2006, and 21 CFR 520.309 is amended to reflect the approval. In accordance with the freedom of information provisions of 21 CFR part 20 and 21 CFR 514.11(e)(2)(ii), a summary of safety and effectiveness data and information submitted to support approval of this application may be seen in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday. The agency has determined under 21 CFR 25.33(a)(1) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required. This rule does not meet the definition of “rule” in 5 U.S.C. 804(3)(A) because it is a rule of “particular applicability.” Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801-808. List of Subjects in 21 CFR Part 520 Animal drugs. Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, 21 CFR part 520 is amended as follows: PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS 1. The authority citation for 21 CFR part 520 continues to read as follows: Authority: 21 U.S.C. 360b. 2. In § 520.309, remove paragraphs (d)(2)(i) and (d)(2)(ii), and revise paragraphs (b)(2) and (d)(2) to read as follows: § 520.309 Carprofen.
(b)* * *
(2)No. 000115 for use of product described in paragraph (a)(1) as in paragraph
(d)of this section.
(d)* * *
(2)*Indications for use* . For the relief of pain and inflammation associated with osteoarthritis and for the control of postoperative pain associated with soft tissue and orthopedic surgeries. Dated: August 18, 2006. Steven D. Vaughn, Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine. [FR Doc. E6-14508 Filed 8-31-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 522 Implantation or Injectable Dosage Form New Animal Drugs; Lincomycin AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration
(FDA)is amending the animal drug regulations to reflect approval of an abbreviated new animal drug application (ANADA) filed by Cross Vetpharm Group Ltd. The ANADA provides for the use of lincomycin injectable solution in swine for the treatment of infectious arthritis and mycoplasma pneumonia. DATES: This rule is effective September 1, 2006. FOR FURTHER INFORMATION CONTACT: John K. Harshman, Center for Veterinary Medicine (HFV-104), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-0169, e-mail: *john.harshman@fda.hhs.gov* . SUPPLEMENTARY INFORMATION: Cross Vetpharm Group Ltd., Broomhill Rd., Tallaght, Dublin 24, Ireland, filed ANADA 200-368 that provides for use of LINCOMED 100 (lincomycin hydrochloride) and LINCOMED 300 (lincomycin hydrochloride) in swine for the treatment of infectious arthritis and mycoplasma pneumonia. Cross Vetpharm Group Ltd.'s LINCOMED 100 and LINCOMED 300 are approved as generic copies of LINCOMIX 100 Injectable and LINCOMIX 300 Injectable, sponsored by Pharmacia & Upjohn Co., a Division of Pfizer, Inc., under NADA 034 025. The ANADA is approved as of July 27, 2006, and the regulations are amended in § 522.1260 to reflect the approval. The basis of approval is discussed in the freedom of information summary. In accordance with the freedom of information provisions of 21 CFR part 20 and 21 CFR 514.11(e)(2)(ii), a summary of safety and effectiveness data and information submitted to support approval of this application may be seen in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday. The agency has determined under 21 CFR 25.33(a)(1) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required. This rule does not meet the definition of “rule” in 5 U.S.C. 804(3)(A) because it is a rule of “particular applicability.” Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801-808. List of Subject in 21 CFR Part 522 Animal drugs. Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, 21 CFR part 522 is amended as follows: PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS 1. The authority citation for 21 CFR part 522 continues to read as follows: Authority: 21 U.S.C. 360b. 2. In § 522.1260, add paragraphs (a)(4) and (b)(4) to read as follows: § 522.1260 Lincomycin.
(a)* * *
(4)100 or 300 mg lincomycin.
(b)* * *
(4)No. 061623 for use of concentrations in paragraph (a)(4) of this section as in paragraph (e)(2) of this section. Dated: August 10, 2006. Stephen F. Sundlof, Director, Center for Veterinary Medicine. [FR Doc. E6-14509 Filed 8-31-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF JUSTICE Drug Enforcement Administration 21 CFR Part 1308 [Docket No. DEA-289I] RIN 1117-AB04 Schedules of Controlled Substances: Exempt Anabolic Steroid Products AGENCY: Drug Enforcement Administration (DEA), Department of Justice. ACTION: Interim rule and request for comments. SUMMARY: The Drug Enforcement Administration
(DEA)is designating six pharmaceutical preparations as exempt anabolic steroid products under the Controlled Substances Act. This action is part of the ongoing implementation of the Anabolic Steroids Control Act of 1990. DATES: This rule is effective September 1, 2006. Written comments must be postmarked, and electronic comments must be sent, on or before October 31, 2006. ADDRESSES: To ensure proper handling of comments, please reference Docket No. DEA-289 on all written and electronic correspondence. Written comments sent via regular mail should be sent to the Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration, Washington, DC 20537, Attention: DEA Federal Register Representative/ODL. Written comments sent via express mail should be sent to DEA Headquarters, Attention: DEA Federal Register Representative/ODL, 2401 Jefferson-Davis Highway, Alexandria, VA 22301. Comments may be sent electronically to *dea.diversion.policy@usdoj.gov.* Comments may also be sent electronically through *http://www.regulations.gov* using the electronic comment form provided at that site. DEA will accept attachments to electronic comments in Microsoft Word, Word Perfect, Adobe PDF, or Excel file formats only. DEA will not accept any file formats other than those specifically listed here. FOR FURTHER INFORMATION CONTACT: Christine A. Sannerud, Ph.D., Chief, Drug and Chemical Evaluation Section, Office of Diversion Control, Drug Enforcement Administration, Washington, DC 20537, Telephone:
(202)307-7183. SUPPLEMENTARY INFORMATION: Background The Anabolic Steroids Control Act
(ASCA)of 1990 (Title XIX of Pub. L. 101-647) placed anabolic steroids into Schedule III of the Controlled Substances Act
(CSA)(21 U.S.C. 801 *et seq.* ). Section 1903 of the ASCA provides that the Attorney General may exempt products which contain anabolic steroids from all or any part of the Controlled Substances Act if the products have no significant potential for abuse. The authority to exempt these products was delegated from the Attorney General to the Administrator of the Drug Enforcement Administration (28 CFR 0.100(b)), who in turn, redelegated this authority to the Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration (28 CFR Part 0, Appendix to Subpart R, section 7(g)). The procedure for implementing this section of the ASCA is found in § 1308.33 of Title 21 of the Code of Federal Regulations. Three applications which were in conformance with 21 CFR 1308.33 were received and forwarded to the Secretary of Health and Human Services for evaluation. The purpose of this rule is to identify six products which the Deputy Assistant Administrator, Office of Diversion Control, finds meet the exempt anabolic steroid product criteria. Anabolic Steroid Products Being Added to the List of Products Exempted From Application of the CSA DEA received three letters dated June 8, 2005, July 1, 2005 and August 22, 2005, written to the DEA on behalf of Interpharm Inc., Lannett Company Inc., and ANDAPharm, LLC, respectively. Each of these three letters contained an application to exempt from control under the CSA two products, each containing esterified estrogens and methyltestosterone. In two letters dated November 14, 2005, DEA provided a copy of the Lannett and ANDAPharm applications to the Department of Health and Human Services
(DHHS)along with a request for evaluation and a recommendation. In a letter dated November 15, 2005, DEA provided a copy of the Interpharm application to DHHS along with a request for evaluation and recommendation. In three separate letters dated March 30, 2006, the Assistant Secretary of Health for DHHS recommended that all six products, two products of esterified estrogen and methyltestosterone from each of the three applications, be exempted from control under the CSA based on their similarity to the products Estratest ® , Estratest ® H.S., Essian TM and Essian TM H.S., which have been exempted from control under the CSA. DEA agrees with DHHS regarding the similarity of these products to products which have already been exempted from the regulatory controls of the Controlled Substances Act. Further, after reviewing several law enforcement databases, DEA has not found evidence of significant abuse or trafficking of these types of products. The Deputy Assistant Administrator, having reviewed the applications, recommendations of the Secretary, and other relevant information, finds that the following six products have no significant potential for abuse: Esterified Estrogens and Methyltestosterone, USP (1.25 mg/2.5 mg); Esterified Estrogens and Methyltestosterone, USP (0.625 mg/ 1.25 mg); Methyltestosterone and Esterified Estrogens (2.5 mg/1.25 mg); Methyltestosterone and Esterified Estrogens (1.25 mg/0.625 mg); Esterified Estrogens/Methyltestosterone (1.25 mg/2.5 mg) Tablet; and Esterified Estrogens/Methyltestosterone (0.625 mg/1.25 mg) Tablet H.S. Information on these products is given below. Exempt Anabolic Steroid Products Trade name Company Form Ingredients Quantity Esterified Estrogens and Methyltestosterone, USP (1.25 mg/2.5 mg) Interpharm, Inc Tablets Esterfied Estrogens Methyltestosterone 1.25 mg/Tablet. 2.5 mg/Tablet. Esterified Estrogens and Methyltestosterone, USP (0.625 mg/1.25 mg) Interpharm, Inc Tablets Esterfied Estrogens Methyltestosterone 0.625 mg/Tablet. 1.25 mg/Tablet. Methyltestosterone and Esterified Estrogens (2.5 mg/1.25 mg) Lannett Company, Inc Tablets Esterfied Estrogens Methyltestosterone 1.25 mg/Tablet. 2.5 mg/Tablet. Methyltestosterone and Esterified Estrogens (Half Strength) (1.25 mg/0.625 mg) Lannett Company, Inc Tablets Esterfied Estrogens Methyltestosterone 0.625 mg/Tablet. 1.25 mg/Tablet. Esterified Estrogens/Methyltestosterone, (1.25 mg/2.5 mg) Tablet ANDAPharm, LLC Tablets Esterfied Estrogens Methyltestosterone 1.25 mg/Tablet. 2.5 mg/Tablet. Esterified Estrogens/Methyltestosterone, (0.625 mg/1.25 mg) Tablet ANDAPharm, LLC Tablets Esterfied Estrogens Methyltestosterone 0.625 mg/Tablet. 1.25 mg/Tablet. Therefore, the Deputy Assistant Administrator hereby orders that the above anabolic steroid products be added to the list of products excluded from application of certain controls of the CSA and referenced in 21 CFR 1308.34. Interested persons are invited to submit their comments to this interim rule. If any comments or objections raise significant issues regarding any finding of fact or conclusion of law upon which this order is based, the Deputy Assistant Administrator shall immediately suspend the effectiveness of this order until he may reconsider the application in light of the comments and objections filed. Thereafter, the Deputy Assistant Administrator shall reinstate, revoke, or amend his original order as he determines appropriate. Regulatory Certifications Regulatory Flexibility Act The granting of exemption status relieves persons who handle the exempted products in the course of legitimate business from the registration, recordkeeping, security, and other requirements imposed by the CSA. Accordingly, the Deputy Assistant Administrator certifies that this action will not have a significant economic impact upon a substantial number of small entities whose interests must be considered under the Regulatory Flexibility Act (5 U.S.C. 605(b)). Executive Order 12866 The Deputy Assistant Administrator has determined that this is not a “significant rule,” as that term is used in Executive Order 12866. This rule exempts the identified steroid products from the regulatory controls that apply to controlled substances. Therefore, this rule has not been reviewed by the Office of Management and Budget. Executive Order 12988 This interim rule meets the applicable standards set forth in sections 3(a) and 3(b)(2) of Executive Order 12988 Civil Justice Reform. Executive Order 13132 This interim 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 law. Accordingly, this rulemaking does not have federalism implications warranting the application of Executive Order 13132. Unfunded Mandates Reform Act of 1995 This interim rule will not result in the expenditure by State, local or tribal governments, in the aggregate, or by the private sector, of $117,000,000 or more 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. Small Business Regulatory Enforcement Fairness Act of 1996 This interim rule is not a major rule as defined by section 804 of the Small Business Regulatory Enforcement Fairness Act of 1996. 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. Administrative Procedure Act An agency may find good cause to exempt a rule from certain provisions of the Administrative Procedure Act (5 U.S.C. 553), including Notice of Proposed Rulemaking and the opportunity for public comment, if it is determined to be unnecessary, impracticable, or contrary to the public interest (5 U.S.C. 553(b)(3)(B). Further, the Administrative Procedure Act permits an agency to make this rule effective upon the date of publication if the rule is “a substantive rule which grants or recognizes an exemption or relieves a restriction” (5 U.S.C. 553(d)(1)). As the rule adds six anabolic steroid products to the list of products exempted from regulatory control under the Controlled Substances Act and provides a benefit to the affected public, DEA finds that this rule meets the criteria set forth in 5 U.S.C. 553(b)(3)(B) and 5 U.S.C. 553(d)(1) for an exception to the usual notice and comment process. PART 1308—SCHEDULES OF CONTROLLED SUBSTANCES Pursuant to the authority vested in the Attorney General by section 1903 of the Anabolic Steroids Control Act of 1990, delegated to the Administrator of the Drug Enforcement Administration pursuant to 21 U.S.C. 871(a) and 28 CFR 0.100, and redelegated to the Deputy Assistant Administrator of the DEA Office of Diversion Control pursuant to 28 CFR part 0, Appendix to Subpart R, section 7(g), the Deputy Assistant Administrator hereby orders that the following compounds, mixtures, or preparations containing anabolic steroids be exempted from application of sections 302 through 309 and sections 1002 through 1004 of the Controlled Substances Act (21 U.S.C. 822-829 and 21 U.S.C. 952-954) and 21 CFR 1301.13, 1301.22, 1301.71 through 1301.76 for administrative purposes only and be included in the list of products described in 21 CFR 1308.34. New Exempt Anabolic Steroid Products Trade name Company Form Ingredients Quantity Esterified Estrogens and Methyltestosterone, USP (1.25 mg/2.5 mg) Interpharm, Inc Tablets Esterfied Estrogens Methyltestosterone 1.25 mg/Tablet. 2.5 mg/Tablet. Esterified Estrogens and Methyltestosterone, USP (0.625 mg/1.25 mg) Interpharm, Inc Tablets Esterfied Estrogens Methyltestosterone 0.625 mg/Tablet. 1.25 mg/Tablet. Methyltestosterone and Esterified Estrogens (2.5 mg/1.25 mg) Lannett Company, Inc Tablets Esterfied Estrogens Methyltestosterone 1.25 mg/Tablet. 2.5 mg/Tablet. Methyltestosterone and Esterified Estrogens (Half Strength) (1.25 mg/0.625 mg) Lannett Company, Inc Tablets Esterfied Estrogens Methyltestosterone 0.625 mg/Tablet. 1.25 mg/Tablet. Esterified Estrogens/Methyltestosterone, (1.25 mg/2.5 mg) Tablet ANDAPharm, LLC Tablets Esterfied Estrogens Methyltestosterone 1.25 mg/Tablet. 2.5 mg/Tablet. Esterified Estrogens/Methyltestosterone, (0.625 mg/1.25 mg) Tablet ANDAPharm, LLC Tablets Esterfied Estrogens Methyltestosterone 0.625 mg/Tablet. 1.25 mg/Tablet. Dated: August 24, 2006. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control. [FR Doc. E6-14516 Filed 8-31-06; 8:45 am] BILLING CODE 4410-09-P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2005-0035; FRL-8084-6] Benthiavalicarb-Isopropyl; Pesticide Tolerance AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. SUMMARY: This regulation establishes tolerances for the combined residues of benthiavalicarb-isopropyl, isopropyl[(S)-1-[[[(1R)-1-(6-fluoro-2-benzothiazolyl)ethyl]amino] carbonyl]-2-methylpropyl]carbamate and isopropyl[(S)-1-[[[(1S)-1-(6-fluoro-2-benzothiazolyl)ethyl]amino] carbonyl]-2-methylpropyl]carbamate, in or on imported grape at 0.25 parts per million (ppm), tomato at 0.45 ppm, and grape, raisin at 1.0 ppm. K-I Chemical U.S.A., Inc., requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA). DATES: This regulation is effective September 1, 2006. Objections and requests for hearings must be received on or before October 31, 2006, 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-2005-0035. All documents in the docket are listed in the index for the docket. 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: Mary Waller, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:
(703)308-9354; e-mail address: *waller.mary@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), 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 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. 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 40 CFR part 180 through the Government Printing Office's pilot e-CFR site at *http://www.gpoaccess.gov/ecfr* . To access the OPPTS Harmonized Guidelines referenced in this document, go directly to the guidelines at *http://www.epa.gpo/opptsfrs/home/guidelin.htm* C. Can I File an Objection or Hearing Request? Under section 408(g) of FFDCA, as amended by FQPA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. 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-2005-0035 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 on or before October 31, 2006. 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 your copies, identified by docket ID number EPA-HQ-OPP-2005-0035, 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. Background and Statutory Findings In the **Federal Register** of March 9, 2005 (70 FR 11648) (FRL-7699-4), 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 3E6545) by K-I Chemical U.S.A., Inc., 11 Martine Ave., Suite 970, White Plains, NY 10606. The petition requested that 40 CFR part 180 be amended by establishing tolerances for the combined residues of the fungicide isopropyl[(S)-1-[(R)-1-(6-fluoro-1,3-benzothiazol-2-yl)ethyl]carbamoyl-2-methylpropyl]carbamate in or on the raw agricultural commodity imported grapes at 0.5 ppm, grape processed commodities juice and wine at 0.5 ppm, imported tomato at 0.5 ppm, tomato processed commodities at 0.5 ppm, and tomato paste at 1.5 ppm. That notice included a summary of the petition prepared by K-I Chemical U.S.A., Inc., the registrant. One comment from a private citizen was received in response to the notice of filing. EPA's response to this comment is discussed in Unit IV. 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....” EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. For further discussion of the regulatory requirements of section 408 of FFDCA and a complete description of the risk assessment process, see *http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm* . III. Aggregate Risk Assessment and Determination of Safety Consistent with section 408(b)(2)(D) of FFDCA, 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, consistent with section 408(b)(2) of FFDCA, for a tolerance for combined residues of benthiavalicarb-isopropyl on imported grape at 0.25 ppm, tomato at 0.45 ppm, and grape, raisin at 1.0 ppm. 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 toxic effects caused by benthiavalicarb-isopropyl 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* under document ID number EPA-HQ-OPP-2005-0035-0001. B. Toxicological Endpoints For hazards that have a threshold below which there is no appreciable risk, the dose at which no adverse effects are observed (the NOAEL) from the toxicology study identified as appropriate for use in risk assessment is used to estimate the toxicological level of concern (LOC). However, the lowest dose at which adverse effects of concern are identified (the LOAEL) is sometimes used for risk assessment if no NOAEL was achieved in the toxicology study selected. An uncertainty factor
(UF)is applied to reflect 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. The linear default risk methodology (Q*) is the primary method currently used by the Agency to quantify non-threshold hazards such as cancer. The Q* approach assumes that any amount of exposure will lead to some degree of cancer risk, estimates risk in terms of the probability of occurrence of additional cancer cases. More information can be found on the general principles EPA uses in risk characterization at *http://www.epa.gov/oppfead1/trac/science* . A summary of the toxicological endpoints for benthiavalicarb-isopropyl used for human risk assessment is shown in Table 1 of this unit: **Table 1.—Summary of Toxicological Doses and Endpoints for Benthiavalicarb-Isopropyl for Use in Human Risk Assessment** Exposure/scenario Dose used in risk assessment, UF Special FQPA SF and level of concern for risk assessment Study and toxicological effects Acute dietary All populations including infants and children when applicable NOAEL = N/S UF = N/A Acute RfD = N/A FQPA SF = N/A No studies resulted in toxic effects attributable to one or two exposures. Therefore an acute endpoint was not selected for dietary exposure. Chronic dietary (All populations) NOAEL= 9.9 milligrams/kilograms/day (mg/kg/day) UF = 100 Chronic RfD = 0.099 mg/kg/day FQPA SF = 1X cPAD = 0.099 mg/kg/day Chronic oral toxicity in rats LOAEL = 249.6 mg/kg/day based on nephrotoxicity and hepatotoxicity. Cancer (Oral, dermal, inhalation) Likely to be carcinogenic to humans Q1*= 6.2795 x 10 - 2 Based on increases in male mouse liver combined adenomas and/or carcinomas and/or blastomas. UF = uncertainty factor, FQPA SF = Special FQPA safety factor, NOAEL = no-observed-adverse-effect-level, LOAEL = lowest-observed-adverse-effect-level, PAD = population adjusted dose (a = acute, c = chronic) RfD = reference dose, MOE = margin of exposure, LOC = level of concern, NA = Not Applicable. C. Exposure Assessment 1. *Dietary exposure from food and feed uses* . Benthiavalicarb-isopropyl is a new chemical and these are the first tolerances to be proposed for this chemical. Risk assessments were conducted by EPA to assess dietary exposures from benthiavalicarb-isopropyl 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. No such effects were identified in the toxicological studies for benthiavalicarb-isopropyl; therefore, a quantitative acute dietary exposure assessment is unnecessary. ii. *Chronic exposure* . In conducting the chronic dietary exposure assessment EPA used the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM-FCID TM ), which incorporates food consumption data as reported by respondents in the USDA 1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII), for each commodity: Estimates of percent crop imported
(PCI)were used in place of percent crop treated
(PCT)values as PCI values more appropriately estimate exposure to benthiavalicarb-isopropyl since the chemical is not being proposed for registration in the United States and residues will only result on imported grape and tomato commodities. Average field trial values of 0.06958 ppm for grapes, 0.1133 ppm for greenhouse grown tomatoes, and 0.00767 ppm for field grown tomatoes were used. It is unlikely that average field trial values and PCI values will be exceeded in the future. Average field trial values almost always exceed the expected residue levels found on crops at the time of consumption. When field trials are performed, the maximum allowable application rate is used and crops are harvested at the minimum PHI. Samples are stored frozen until analysis to ensure minimal degradation of residues. However, in actual practice, growers will not usually use the maximum application rates for economic reasons. Additionally, it has been observed from previous analysis, that monitoring data are often one to two orders of magnitude lower than field trial data. Moreover, the registrant is planning on marketing benthiavalicarb-isopropyl in Europe only. For this risk assessment, PCI estimates were assumed for all imports, not just grape and tomato commodities from Europe. Lastly, the Agency assumes 100% of the imported crop will be treated. The actual PCI will likely be considerably lower. The following processing factors derived from processing studies were used: 0.47 for grapes juice, 0.97 for grape wine, 3.67 for raisins, 1.16 for tomato puree, and 0.49 for tomato juice. Default processing factors of 5.4 for tomato paste and 14.3 for dried tomatoes were used. iii. *Cancer* . The cancer exposure assessment was conducted using the same exposure assumptions as were used in the chronic exposure assessment. iv. *Anticipated residue and 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 chemicals 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. Following the initial data submission, EPA is authorized to require similar data on a time frame it deems appropriate. For the present action, EPA will issue such data call-ins for information relating to anticipated residues as are required by FFDCA section 408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Such data call-ins will be required to be submitted no later than 5 years from the date of issuance of this tolerance. Section 408(b)(2)(F) of FFDCA states that the Agency may use data on the actual percent of food treated for assessing chronic dietary risk only if the Agency can make the following findings: Condition 1, that the data used are reliable and provide a valid basis to show what percentage of the food derived from such crop is likely to contain such pesticide residue. Condition 2, that the exposure estimate does not underestimate exposure for any significant subpopulation group. Condition 3, if data are available on pesticide use and food consumption in a particular area, the exposure estimate does not understate exposure for the population in such area. In addition, the Agency must provide for periodic evaluation of any estimates used. To provide for the periodic evaluation of the estimate of PCT as required by section 408(b)(2)(F) of FFDCA, EPA may require registrants to submit data on PCT. The Agency used PCI information as follows: Tomatoes-36%, processed tomato commodities-5.8%, grapes-45%, grape juice-44%, wine-23%, and raisins-10%. The Agency believes that the three conditions listed in Unit III. have been met. With respect to Condition 1, PCI estimates are derived from the U.S. Department of Agriculture, Economic Research Service data which are reliable and have a valid basis. The Agency is reasonably certain that the percentage crop imported values will not be exceeded in the future. The conservative assumptions were made that 100% of the grape and tomato commodities imported from all over the world would be treated. Data for grape commodities were taken from 5 year averages and were compared to the annual data points of each data source. It was observed that crop production patterns and consumption and preferences were more stable and changed more slowly. For tomatoes commodities, data was taken from 1998 to 2004 with no increases occurring over that time period. It is very unlikely that estimates of import would be exceeded in the near future due to crop production patterns and consumption and preferences are more stable and change more slowly. 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 the national food consumption surveys, EPA does not have available information on the regional consumption of food to which benthiavalicarb-isopropyl may be applied in a particular area. 2. *Dietary exposure from drinking water* . The proposed tolerances are for imported commodities only, and there are no current or proposed U.S. registrations for this chemical. Therefore, there is no potential for exposure to benthiavalicarb-isopropyl through drinking water, and a drinking water assessment was not performed. 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). There are no products containing benthiavalicarb-isopropyl proposed or registered for residential use or that may be applied by commercial applicators to residential sites. Therefore, a residential exposure assessment was not performed. 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.” Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to benthiavalicarb-isopropyl and any other substances and benthiavalicarb-isopropyl does not appear to produce a toxic metabolite produced by other substances. Although benthiavalicarb-isopropyl is a carbamate compound, it is not a member of the class of insecticides known as the N-methyl carbamates for which the Agency is presently conducting a cumulative risk assessment. The substituents on the benthiavalicarb-isopropyl nitrogen atom are much larger than the methyl group in the insecticides. While the N-methyl carbamates are neurotoxicants based on their ability to inhibit the enzyme cholinesterase, there is no evidence of neurotoxicity or neuropathology in the hazard database for benthiavalicarb-isopropyl. Benthiavalicarb-isopropyl is also not a member of the thiocarbamate class of herbicides or the dithiocarbamate class of fungicides. For the purposes of this tolerance action, therefore, EPA has not assumed that benthiavalicarb-isopropyl has a common mechanism of toxicity with other substances. 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 released by EPA's Office of Pesticide Programs concerning common mechanism determinations and procedures for cumulating effects from substances found to have a common mechanism on EPA's Web site at *http://www.epa.gov/pesticides/cumulative* . D. Safety Factor for Infants and Children 1. *In general* . Section 408 of FFDCA provides that EPA shall apply an additional 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. Margins of safety are incorporated into EPA risk assessments either directly through use of a MOE analysis or through using uncertainty (safety) factors in calculating a dose level that poses no appreciable risk to humans. 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 safety factor value based on the use of traditional UFs and/or special FQPA SFs, as appropriate. 2. *Prenatal and postnatal sensitivity* . There are no residual uncertainties for pre/postnatal toxicity. Developmental studies in two species (both rat and rabbit) and a 2-generation reproduction study in rats did not show any evidence of developmental or reproductive toxicity. Evidence suggests that there is no concern for fetuses exposed to benthiavalicarb-isopropyl *in utero* or post-natally. There was no evidence of neurotoxicity throughout the entire toxicology database and there was an absence of adverse developmental and reproductive effects. A developmental neurotoxicity study is not necessary at this time. The Agency determined that reliable data support reducing the FQPA SF to 1X. This determination was based on the following: • There is no evidence of increased susceptibility to fetuses or pups following *in utero* or postnatal exposure in the developmental toxicity studies in rats or rabbits, and in the 2-generation rat reproduction study. • There are no residual uncertainties concerning pre and postnatal toxicity and no neurotoxicity concerns. • The toxicological database is complete for FQPA assessment. • The chronic and cancer dietary food exposure assessments utilizes anticipated residues
(ARs)calculated from average field trial data and worldwide estimates of PCI for most commodities. Although refined, the assessments are based on reliable data and will not underestimate exposure or risk. • There is no potential for drinking water exposure. • There is no potential for residential exposure. 3. *Conclusion* . There is a complete toxicity data base for benthiavalicarb-isopropyl and exposure data are complete or are estimated based on data that reasonably accounts for potential exposures. EPA determined that the 10X SF to protect infants and children should be removed. The FQPA factor is removed because there are no residential uncertainties for pre/postnatal toxicity. E. Aggregate Risks and Determination of Safety 1. *Acute risk* . An acute endpoint was not identified in any of the toxicity studies. Therefore, no acute risk is expected from exposure to benthiavalicarb-isopropyl. 2. *Chronic risk* . Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to benthiavalicarb-isopropyl from food will utilize <1 % of the cPAD for the U.S. population, <1 % of the cPAD for all infants <1 year old, and <1 % of the cPAD for children 1-2 years old, the most highly exposed population subgroup. There are no residential uses for benthiavalicarb-isopropyl. There are no current or proposed U.S. registrations of benthiavalicarb-isopropyl and as a result there is no expectation of exposure through drinking water. Therefore, EPA does not expect the aggregate exposure (dietary) to exceed 100% of the cPAD. 3. *Aggregate cancer risk for U.S. population* . Applying the cancer potency (Q1*) value of 0.063 (mg/kg/day) - 1 to the exposure value results in a cancer risk estimate of 1.6 x 10 - 6 . This cancer risk estimate falls within the range of 1 x 10 - 6 , the risk level considered to be negligible by EPA; therefore, the estimated cancer risk is below the Agency's level of concern. 4. *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, and to infants and children from aggregate exposure to benthiavalicarb-isopropyl residues. IV. Other Considerations A. Analytical Enforcement Methodology Adequate enforcement methodology, Gas Chromatography/Nitrogen-Phosphorous detector (GC/NPD) Method RCC. Ho. 665943 is available to enforce the tolerance expression. The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number:
(410)305-2905; e-mail address: *residuemethods@epa.gov* . B. International Residue Limits There are currently no established Codex, Canadian, or Mexican maximum residue limits
(MRLs)for benthiavalicarb-isopropyl. C. Response to Comments One comment was received from a private citizen objecting to profiteering, animal testing, and establishing tolerances. The comments contained no scientific data or evidence to rebut the Agency's conclusion that there is a reasonable certainty that no harm will result from aggregate exposure to benthiavalicarb-isopropyl, including all anticipated dietary exposures and other exposures for which there is reliable information. The EPA has responded to this private citizen's generalized comments on numerous previous occasions, for example, on January 7, 2005 (70 FR 1354) (FRL-7681-9) and on October 29, 2004 (69 FR 63096) (FRL-7691-4). V. Conclusion Therefore, the tolerances are established for combined residues of benthiavalicarb-isopropyl, isopropyl[(S)-1-[[[(1R)-1-(6-fluoro-2-benzothiazolyl)ethyl]amino] carbonyl]-2-methylpropyl]carbamate and isopropyl[(S)-1-[[[(1S)-1-(6-fluoro-2-benzothiazolyl)ethyl] amino] carbonyl]-2-methylpropyl]carbamate, in or on imported grape at 0.25 ppm, tomato at 0.45 ppm, and grape, raisin at 1.0 ppm. As residues do not concentrate in wine, the 0.25 ppm grape tolerance is adequate to cover residues in wine. A separate tolerance for wine is not needed. Based on processing factors and highest average field trial values for field grown tomatoes which are used for processing, separate tolerances are not required for processed tomato commodities. 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 due to its lack of significance, 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). 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* ., 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 under 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 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). 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. 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 final 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 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 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 rule. VII. Congressional Review Act The Congressional Review Act, 5 U.S.C. 801 *et seq.* , as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, 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: August 25, 2006. Anne E. Lindsay, Acting Director, 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 180.618 is added to read as follows: § 180.618 Benthiavalicarb-isopropyl; tolerance for residues.
(a)*General* . Tolerances are established for the combined residues of benthiavalicarb-isopropyl, isopropyl[(S)-1-[[[(1R)-1-(6-fluoro-2-benzothiazolyl)ethyl]amino] carbonyl]-2-methylpropyl]carbamate and isopropyl[(S)-1-[[[(1S)-1-(6-fluoro-2-benzothiazolyl)ethyl]amino] carbonyl]-2-methylpropyl]carbamate, in or on the following raw agricultural commodities: Commodity Parts per million Grape, imported 0.25 Grape, raisin 1.0 Tomato 0.45 Note: There are no U.S. registrations as of July 30, 2006.
(b)*Section 18 emergency exemptions* . [Reserved]
(c)*Tolerances with regional registrations* . [Reserved]
(d)*Indirect of inadvertent residues* . [Reserved] [FR Doc. 06-7313 Filed 8-31-06; 8:45 am]
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  • 14 CFR 39
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  • 5 USC 801-808
  • 21 CFR 522
  • 21 CFR 1308
  • Pub. L. 101-647
  • 28 CFR 0
  • 21 USC 822-829
  • 21 USC 952-954
  • 40 CFR 180
  • 40 CFR 178
  • 40 CFR 2
  • Pub. L. 104-4
  • Pub. L. 104-113
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