Rules and Regulations. Final rule; correction
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/register/2008/01/30/08-392A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
BILLING CODE 4910-13-M DEPARTMENT OF STATE 22 CFR Part 51 RIN 1400-AC28 [Public Notice: 6084] Revisions to Passport Regulations; Correction AGENCY: Department of State. ACTION: Final rule; correction. SUMMARY: This document contains correction to the revised Passport rule published in the **Federal Register** on November 19, 2007 [Public Notice 5991]. DATE: Effective on February 1, 2008. FOR FURTHER INFORMATION CONTACT: Consuelo Pachon, Office of Legal Affairs and Law Enforcement Liaison, Bureau of Consular Affairs, 2100 Pennsylvania Avenue, NW., Suite 3000, Washington, DC, telephone number 202-663-2431.
Correction The final rule published on November 19, 2007 (72 FR 64930) is corrected as follows: 1. In the SUPPLEMENTARY INFORMATION section, on page 64930, in the third column, final paragraph, the first sentence is corrected by removing the words “for first time passport applicants.” The sentence as corrected reads “The passport application process is designed to verify the citizenship and identity of the applicant.” 2. On page 64932, 22 CFR 51.1(j) is corrected to read as follows:
Ҥ 51.1 Definitions.
(j)*United States* when used in a geographical sense means the continental United States, Alaska, Hawaii, Puerto Rico, Guam, the Virgin Islands of the United States, and all other United States territories and possessions. 3. On page 64936, 22 CFR 51.51(e) is corrected to place quotes around the term “enhanced border security” and reads as follows: “§ 51.51 Passport fees.
(e)An “enhanced border security” surcharge on the filing of each application for a regular passport in an amount set administratively by the Department and published in the Schedule of Fees for Consular Services. Dated: January 24, 2008. Ann Barrett, Deputy Assistant Secretary, Bureau of Consular Affairs, Department of State. [FR Doc. E8-1670 Filed 1-29-08; 8:45 am] BILLING CODE 4710-06-P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R05-OAR-2007-0183; FRL-8514-5] Approval and Promulgation of Air Quality Implementation Plans; Illinois; Revisions to Emission Reduction Market System AGENCY: Environmental Protection Agency (EPA). ACTION: Direct final rule. SUMMARY: In 1997, Illinois adopted and submitted rules establishing a cap and trade program regulating emissions of volatile organic compounds (VOC). The program, known as the Emission Reduction Market System (ERMS), was designed to address VOC sources in the Chicago area with potential to emit at least 25 tons per year. Then, in 2004, the Chicago ozone nonattainment area was in effect reclassified from severe to moderate, which according to EPA guidance revised the applicable definition of major sources from 25 tons per year to 100 tons per year. This “reclassification” could have resulted in the program no longer including sources with potential to emit more than 25 but less than 100 tons per year. Instead, Illinois adopted rule revisions, submitted to EPA on January 10, 2007, which required that these sources remain part of the program. Illinois' rule revisions also address other ramifications of the “reclassification.” EPA is approving these rule revisions. DATES: This direct final rule will be effective March 31, 2008, unless EPA receives adverse comments by February 29, 2008. If adverse comments are received, EPA will publish a timely withdrawal of the direct final rule in the **Federal Register** informing the public that the rule will not take effect. ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R05-OAR-2007-0183, by one of the following methods: 1. *http://www.regulations.gov* : Follow the on-line instructions for submitting comments. 2. *Email:* *mooney.john@epa.gov* . 3. *Fax:*
(312)886-5824. 4. *Mail:* John M. Mooney, Chief, Criteria Pollutant Section, Air Programs Branch (AR-18J), U.S. Environmental Protection Agency, 77 West Jackson Boulevard, Chicago, Illinois 60604. 5. *Hand Delivery:* John M. Mooney, Chief, Criteria Pollutant Section, Air Programs Branch (AR-18J), U.S. Environmental Protection Agency, 77 West Jackson Boulevard, Chicago, Illinois 60604. Such deliveries are only accepted during the Regional Office normal hours of operation, and special arrangements should be made for deliveries of boxed information. The Regional Office official hours of business are Monday through Friday, 8:30 a.m. to 4:30 p.m. excluding Federal holidays. *Instructions:* Direct your comments to Docket ID No. EPA-R05-OAR-2007-0183. EPA's policy is that all comments received will be included in the public docket without change and may be made available online at *www.regulations.gov,* including any personal information provided, unless the comment includes information claimed to be Confidential Business Information
(CBI)or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through *www.regulations.gov* or e-mail. The *www.regulations.gov* website is an “anonymous access” system, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an e-mail comment directly to EPA without going through *www.regulations.gov* your e-mail address will be automatically captured and included as part of the comment that is placed in the public docket and made available on the Internet. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD-ROM you submit. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses. *Docket:* All documents in the docket are listed in the *www.regulations.gov* index. Although listed in the index, some information is not publicly available, e.g., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, will be publicly available only in hard copy. Publicly available docket materials are available either electronically in *www.regulations.gov* or in hard copy at the Environmental Protection Agency, Region 5, Air and Radiation Division, 77 West Jackson Boulevard, Chicago, Illinois 60604. This Facility is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. We recommend that you telephone John Summerhays, Environmental Scientist, at
(312)886-6067 before visiting the Region 5 office. FOR FURTHER INFORMATION CONTACT: John Summerhays, Environmental Scientist, Criteria Pollutant Section, Air Programs Branch (AR-18J), Environmental Protection Agency, Region 5, 77 West Jackson Boulevard, Chicago, Illinois 60604,
(312)886-6067, *summerhays.john@epa.gov* . SUPPLEMENTARY INFORMATION: This supplementary information section is arranged as follows: I. Description and Review of Illinois' Submittal II. What Action is EPA Taking? III. Statutory and Executive Order Reviews I. Description and Review of Illinois' Submittal On January 10, 2007, Illinois submitted revisions to Part 205 of Title 35 of the Illinois Administrative Code, entitled “Emissions Reduction Market System” (ERMS). ERMS is a cap and trade program addressing VOC emissions in the Chicago area. Under ERMS, Illinois issues allowances equivalent to 12 percent less than baseline VOC emission levels, and requires affected sources to hold allowances equivalent to their VOC emissions during the ozone season. The program thereby requires overall VOC emission levels to be reduced to 12 percent below baseline levels. The original rules for this program were adopted on November 20, 1997, and were submitted by Bharat Mathur of the Illinois EPA on December 16, 1997. EPA approved those rules on October 15, 2001, at 66 FR 52359. Part 205 requires participation of all major VOC sources in the Chicago area. More specifically, the 1997 version of Section 205.200 that Illinois adopted in 1997 stated that “The requirements of this Part shall apply to any source * * * located in the Chicago ozone nonattainment area that is required to obtain a [Title V permit], and [has VOC emissions during the ozone season of at least 10 tons].” The requirement for a Title V operating permit applies to major sources. Since the Chicago area at that time was classified as a severe ozone nonattainment area, major sources were defined to include sources with the potential to emit 25 tons per year or more of VOC. In 2004, EPA classified the Chicago ozone nonattainment area as moderate for the 8-hour ozone standard, and effective in 2005 rescinded the severe classification for the 1-hour ozone standard. The definition of major sources for moderate ozone nonattainment areas includes sources with the potential to emit 100 tons per year or more of VOC. According to EPA guidance (see 69 FR 23951, April 30, 2004), the replacement of the prior classification of severe with a classification of moderate thus meant that sources with potential to emit at least 25 tons per year but less than 100 tons per year of VOC would no longer be required to have Title V operating permits. As a result, the sources in the Chicago area in this size range would no longer be subject to the ERMS requirements, given the applicability criteria in Section 205.200 as quoted above. Illinois estimated that the loss of these intermediate sized sources from ERMS would result in a loss of 330 tons of VOC emission reduction per ozone season associated with these sources. Illinois sought to avoid this loss of sources from the program. Consequently, Illinois revised Section 205.200 to redefine applicability to include sources with potential to emit at least 25 tons of VOC (and sources otherwise required to have a Title V permit) and at least 10 tons of VOC emissions during the ozone season. By this means, Illinois revised its applicability provisions to include the same set of sources as were included in 1997, notwithstanding the change in the classification of the Chicago area. Under the 1997 rules, Illinois established several elements of the ERMS program by means of Title V permits. Most notably, the source's Title V permit is used to specify the number of allowances to be issued to the source (Cf. Section 205.315) and the source-specific VOC monitoring methods (Cf. Section 205.330). Since ERMS included sources which under EPA's guidance were not subject to a requirement for a Title V permit, the State needed an alternative means of specifying source-specific ERMS provisions. Illinois therefore adopted Section 205.316, to provide that sources that are not required to obtain a Title V permit (i.e., under EPA's guidance, sources with potential emissions between 25 and 100 tons per year) shall either request a Title V permit anyway or apply for a federally enforceable state operating permit (FESOP). The FESOP is to specify the provisions (relating for example to the number of allowances allocated to the source and the source-specific monitoring requirements) that would otherwise be specified in the Title V permit. Title V provides for defining some operations with trivial or no emissions as insignificant activities. The 1997 version of Section 205.220 of Illinois' rules exempts these activities from ERMS. The revised version of Section 205.220 extends this exemption to sources obtaining FESOPs. That is, the revised Section 205.220 provides that any activity meeting the criteria in Part 201 Subpart F of Title 35 of the Illinois Administrative Code for insignificant activities may be exempted from the ERMS program, whether the source is subject to a Title V permit or a FESOP. In ozone nonattainment areas classified as severe, major new sources and existing sources undergoing major modifications must obtain 1.3 tons of offsets for every ton of new emissions. In ozone nonattainment areas classified as moderate, major new sources and existing sources undergoing major modifications need only obtain 1.1 tons of offsets for every ton of new emissions. New source review rules require that any change in offset ratio applies only prospectively, to sources permitted after the change in ratio, and that sources permitted before the change in ratio must continue to have offsets in at least the ratio that applied at the time the source was permitted. Under Section 205.150 of the 1997 ERMS rules, major new sources and sources undergoing major modifications were required to obtain 1.3 allowances for every ton of new emissions. Illinois' revised rules provide for modified ratios as the applicable ratios change. Section 205.150(f)(1) of the revised rules states: “If the nonattainment classification of the Chicago area for ozone is changed such that the required offset ratio is no longer 1.3 to 1 and a new offset ratio applies, as specified in 35 Ill. Adm. Code 203.302, that ratio shall then apply in lieu of the 1.3 to 1 ratio set forth in subsections (c)(2), (d)(1), and
(e)of this Section. Such new ratio shall not apply to any part of a source or any modification already subject to the 1.3 to 1 ratio or other previously effective offset ratio established prior to the effective date of the new ratio.” Section 205.150(f)(2) provides that the ratio becomes 1 to 1 if the Chicago area is redesignated to attainment. These revisions address the ramifications of a revised classification according to EPA guidance as cited above. However, while Illinois was adopting these rule revisions, EPA's ozone implementation guidance was being challenged in court. On December 22, 2006, with clarification on June 8, 2007, the Court of Appeals for the District of Columbia Circuit ruled against elements of EPA's ozone implementation guidance, including the “backsliding” inherent in allowing an area originally classified as severe and subsequently classified as moderate to apply the less stringent major source definition for moderate areas. *South Coast Air Quality Management Dist.* v. *EPA* , 472 F.3d 882 (D.C. Cir. 2006). As stated in a memorandum from Robert Meyers to EPA's Regional Administrators dated October 7, 2007, the effect of the court's ruling is to restore the applicability thresholds and offset ratios of the higher, 1-hour ozone classification. The court's decision also signifies that operating permits under Title V of the Clean Air Act also must be obtained according to major source thresholds as defined for the 1-hour ozone classification, e.g., for sources in the Chicago area with potential emissions of at least 25 tons per year. This decision would also restore the 1.3 to 1 offset ratio for new VOC sources in the Chicago area. The Meyers memorandum states further that EPA intends two rulemakings, the first to establish applicability thresholds and offset ratios in accordance with the court's ruling and the second to develop rules that would define the circumstances under which the provisions associated with 1-hour classifications might be terminated. Fortunately, Illinois' rules achieve the intended effect notwithstanding these developments regarding applicable size thresholds and offset ratios. Section 205.200 provides that Part 205 requirements apply to sources with potential to emit at least 25 tons of VOC per year, without regard to whether the major source threshold is 25 or 100 tons per year. Resumption of a 25 ton per year definition of major source simply means that sources with potential emissions between 25 and 100 tons that were subject to ERMS in 1997 because they were major sources are again subject to ERMS because they are again major sources. Since any source with potential to emit more than 25 tons per year now by definition must obtain a Title V permit, it is a moot point whether the State provides a FESOP option for sources of that size that are not subject to the Title V permitting requirement. With respect to offsets, Section 205.150 simply applies required holding allowances for new sources in accordance with the applicable offset ratio. While the ratio for a time was interpreted to be 1.1 to 1, the court decision means that this ratio is reverting back to 1.3 to 1, and Section 205.150 provides that the ratio used for ERMS shall indeed revert back to 1.3 to 1. Thus, the Illinois rules accommodate the effects of the court's ruling, and the court's ruling does not alter the approvability of Illinois' Part 205 rules. Illinois requested that EPA defer rulemaking on Section 205.150(e). This section provides that new sources providing offsets by holding trading program allowances in the proper ratio need not also provide offsets in their new source permit. Illinois made a similar request for deferral of EPA rulemaking on this section in conjunction with its 1997 submittal of ERMS rules. While a new source may use a shutdown for both purposes, purchasing the necessary allowances from a shutdown source and simultaneously using the shutdown in the new source permit to satisfy offset requirements, the deferral of rulemaking provides that the two requirements must be met independently. Illinois made a corollary change, changing the term “Chicago ozone nonattainment area” to the term “Chicago area.” The term “Chicago area” is defined to mean the same area as the previous term “Chicago ozone nonattainment area,” but the revised term more clearly signifies that the program will remain in effect even if the Chicago area is redesignated as an attainment area. In addition to the rules identified above, Illinois made conforming revisions to multiple other rules. These revisions generally replace the term “Chicago nonattainment area” with the term “Chicago area” or mention FESOPs as a possible vehicle for specifying source-specific provisions to implement the ERMS rules. EPA finds these changes approvable. The change in the applicability provisions merely assures that the original program applicability criteria continue to apply, notwithstanding any change in the classification or designation of the area. The requirement for sources with potential emissions between 25 and 100 tons per year to obtain FESOPs is a reasonable means of implementing the ERMS requirements at any time when these sources are not required to obtain a Title V permit. Illinois' provision for offset ratios, wherein new source emissions are offset at the ratio that reflects the offset ratio that is mandated at the time the permit authorizing the new source emissions is issued, properly matches offset requirements. The use of the term “Chicago area” also properly clarifies that the program continues even if the area is redesignated to attainment. II. What action is EPA taking? EPA is approving Illinois' revisions to the ERMS program, except that EPA is deferring action on Section 205.150(e). EPA is publishing this action without prior proposal because EPA views this as a noncontroversial amendment and anticipates no adverse comments. However, in the proposed rules section of this **Federal Register** publication, EPA is publishing a separate document that will serve as the proposal to approve the state plan if relevant adverse written comments are filed. This rule will be effective March 31, 2008 without further notice unless EPA receives relevant adverse written comments by February 29, 2008. If EPA receives such comments, EPA will withdraw this action before the effective date by publishing a subsequent document that will withdraw the final action. All public comments received will then be addressed in a subsequent final rule based on the proposed action. EPA will not institute a second comment period. Any parties interested in commenting on this action should do so at this time. If EPA does not receive any comments, this action will be effective March 31, 2008. Illinois did not change every rule in part 205. The State submitted only those rules that it changed. Thus, the revised rules being approved here must be viewed in conjunction with the unrevised rules approved at 40 CFR 52.720(c)(158). III. Statutory and Executive Order Reviews Executive Order 12866: Regulatory Planning and Review Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is not a “significant regulatory action” and therefore is not subject to review by the Office of Management and Budget. Executive Order 13211: Actions That Significantly Affect Energy Supply, Distribution, or Use Because it is not a “significant regulatory action” under Executive Order 12866 or a “significant energy action,” this action is also not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001). Regulatory Flexibility Act This action merely approves state law as meeting Federal requirements and imposes no additional requirements beyond those imposed by state law. Accordingly, the Administrator certifies that this rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.). Unfunded Mandates Reform Act Because this rule approves pre-existing requirements under state law and does not impose any additional enforceable duty beyond that required by state law, it does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Order 13175: Consultation and Coordination With Indian Tribal Governments This rule also does not have tribal implications because it will not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified by Executive Order 13175 (59 FR 22951, November 9, 2000). Executive Order 13132: Federalism This action also does not have Federalism implications because it does not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999). This action merely approves a state rule implementing a federal standard, and does not alter the relationship or the distribution of power and responsibilities established in the Clean Air Act. Executive Order 13045: Protection of Children From Environmental Health and Safety Risks This rule also is not subject to Executive Order 13045 “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), because it approves a state rule implementing a Federal Standard. National Technology Transfer Advancement Act In reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. In this context, in the absence of a prior existing requirement for the state to use voluntary consensus standards (VCS), EPA has no authority to disapprove a SIP submission for failure to use VCS. It would thus be inconsistent with applicable law for EPA, when it reviews a SIP submission, to use VCS in place of a SIP submission that otherwise satisfies the provisions of the Clean Air Act. Thus, the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply. Paperwork Reduction Act This rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). 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 the rule in the **Federal Register** . A major rule cannot take effect until 60 days after it is published in the **Federal Register** . This action is not a “major rule” as defined by 5 U.S.C. 804(2). Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by March 31, 2008. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).) List of Subjects in 40 CFR Part 52 Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Ozone, Reporting and recordkeeping requirements, Volatile organic compounds. Dated: December 18, 2007. Bharat Mathur, Acting Regional Administrator, Region 5. For the reasons stated in the preamble, part 52, chapter I, of title 40 of the Code of Federal Regulations is amended as follows: PART 52—[AMENDED] 1. The authority citation for part 52 continues to read as follows: Authority: 42 U.S.C. 7401 et seq. Subpart O—Illinois 2. Section 52.720 is amended by adding paragraph (c)(180) to read as follows: § 52.720 Identification of plan.
(c)* * *
(180)On January 10, 2007, Illinois submitted revisions to its rules for the Emission Reduction Market System. These revisions assure that sources in the Chicago area with potential emissions of VOC between 25 and 100 tons per year will remain subject to the program, irrespective of changes in the area's ozone nonattainment classification or designation and any associated changes in whether such sources are defined to be major sources. EPA is again deferring action on section 205.150(e).
(i)*Incorporation by reference.*
(A)The following sections of 35 Illinois Administrative Code Part 205, as effective June 13, 2005: sections 205.120, 205.130, 205.150 (except for 205.150(e)), 205.200, 205.205, 205.210, 205.220, 205.300, 205.310, 205.315, 205.316, 205.318, 205.320, 205.330, 205.335, 205.337, 205.400, 205.405, 205.410, 205.500, 205.510, 205.610, 205.700, 205.730, 205.750, and 205.760. [FR Doc. E8-806 Filed 1-29-08; 8:45 am] BILLING CODE 6560-50-P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2005-0145; FRL-8347-3] Boscalid; Denial of Objections AGENCY: Environmental Protection Agency (EPA). ACTION: Final order. SUMMARY: In this order, EPA denies objections filed by the Natural Resources Defense Council (“NRDC”) to a final rule under section 408 of the Federal Food, Drug, and Cosmetic Act (“FFDCA”), (21 U.S.C. 346a), establishing tolerances for the pesticide boscalid on various leafy greens. NRDC argues that EPA has unlawfully removed the additional safety factor for the protection of infants and children required by Food Quality Protection Act of 1996. FOR FURTHER INFORMATION CONTACT: Tony Kish, Registration Division, (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: 703-308-9443; e-mail address: *kish.tony@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 that are potentially 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* . C. How Can I Access Electronic Copies of Materials in the Docket? EPA has established a docket for this action under docket identification
(ID)number EPA-HQ-OPP-2005-0145. To access the electronic docket, go to *http://www.regulations.gov* , select “Advanced Search,” then “Docket Search.” Insert the docket ID number where indicated and select the “Submit” button. Follow the instructions on the regulations.gov web site to view the docket index or access available documents. II. Introduction A. What Action Is the Agency Taking? In this order, EPA denies objections filed by the Natural Resources Defense Council (“NRDC”) to a final rule under section 408 of the Federal Food, Drug, and Cosmetic Act (“FFDCA”), (21 U.S.C. 346a), establishing tolerances for the pesticide boscalid on various leafy greens. (Ref. 1). NRDC argues that EPA must retain an additional ten-fold
(10X)safety factor for the protection of infants and children due to data showing that juvenile animals are more sensitive than adults. Retention of this additional safety factor, NRDC contends, shows that the tolerances are unsafe. Additionally, NRDC contends that EPA's tolerance decision was arbitrary and capricious because
(1)EPA failed to explain adequately its reason for not applying a 10X safety factor for infants and children and
(2)the safe dose for boscalid established by EPA is “clearly contrary to the data . . . .” (Id. at 3-4, 7-8). B. What Is the Agency's Authority for Taking This Action? The procedure for filing objections to tolerance actions and EPA's authority for acting on such objections is contained in section 408(g) of the FFDCA and regulations at 40 CFR part 178. (21 U.S.C. 346a(g)). III. Statutory and Regulatory Background A. Statutory Background 1. *In general* . EPA establishes maximum residue limits, or “tolerances,” for pesticide residues in food under section 408 of the FFDCA. (21 U.S.C. 346a). Without such a tolerance or an exemption from the requirement of a tolerance, a food containing a pesticide residue is “adulterated” under section 402 of the FFDCA and may not be legally moved in interstate commerce. (21 U.S.C. 331, 342). Monitoring and enforcement of pesticide tolerances are carried out by the U.S. Food and Drug Administration and the U.S. Department of Agriculture. Section 408 was substantially rewritten by the Food Quality Protection Act of 1996 (“FQPA”), which added the provisions discussed below establishing a detailed safety standard for pesticides and additional protections for infants and children. EPA also regulates pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (“FIFRA”), (7 U.S.C. 136 et seq). While the FFDCA authorizes the establishment of legal limits for pesticide residues in food, FIFRA requires the approval of pesticides prior to their sale and distribution, (7 U.S.C. 136a(a)), and establishes a registration regime for regulating the use of pesticides. FIFRA regulates pesticide use in conjunction with its registration scheme by requiring EPA review and approval of pesticide labels and specifying that use of a pesticide inconsistent with its label is a violation of Federal law. (7 U.S.C. 136j(a)(2)(G)). In the FQPA, Congress integrated action under the two statutes by requiring that the safety standard under the FFDCA be used as a criterion in FIFRA registration actions as to pesticide uses which result in dietary risk from residues in or on food, (7 U.S.C. 136(bb)), and directing that EPA coordinate, to the extent practicable, revocations of tolerances with pesticide cancellations under FIFRA. (21 U.S.C. 346a(l)(1)). 2. *Safety standard for pesticide tolerances* . A pesticide tolerance may only be promulgated by EPA if the tolerance is “safe.” (21 U.S.C. 346a(b)(2)(A)(i)). “Safe” is defined by the statute 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.” (21 U.S.C. 346a(b)(2)(A)(ii)). Section 408 directs EPA, in making a safety determination, to “consider, among other relevant factors- . . . . available information concerning the aggregate exposure levels of consumers (and major identifiable subgroups of consumers) to the pesticide chemical residue and to other related substances, including dietary exposure under the tolerance and all other tolerances in effect for the pesticide chemical residue, and exposure from other non-occupational sources.” (21 U.S.C. 346a(b)(2)(D)(vi)). Section 408(b)(2)(C) requires EPA to give special consideration to risks posed to infants and children. Specifically, this provision states that EPA “shall assess the risk of the pesticide chemical based on available information concerning the special susceptibility of infants and children to the pesticide chemical residues, including neurological differences between infants and children and adults, and effects of *in utero* exposure to pesticide chemicals . . . .” (21 U.S.C. 346a(b)(2)(C)(i)(II) and (III)). This provision further directs that “[i]n the case of threshold effects, . . . an additional tenfold margin of safety for the pesticide chemical residue and other sources of exposure shall be applied for infants and children to take into account potential pre- and post-natal toxicity and completeness of the data with respect to exposure and toxicity to infants and children.” (21 U.S.C. 346a(b)(2)(C)). EPA is permitted to “use a different margin of safety for the pesticide chemical residue only if, on the basis of reliable data, such margin will be safe for infants and children.” (Id.). The additional safety margin for infants and children is referred to throughout this order as the “children's safety factor.” 3. *Procedures for establishing, amending, or revoking tolerances* . Tolerances are established, amended, or revoked by rulemaking under the unique procedural framework set forth in the FFDCA. Generally, the rulemaking is initiated by the party seeking to establish, amend, or revoke a tolerance by means of filing a petition with EPA. (See 21 U.S.C. 346a(d)(1)). EPA publishes in the **Federal Register** a notice of the petition filing and requests public comment. (21 U.S.C. 346a(d)(3)). After reviewing the petition, and any comments received on it, EPA may issue a final rule establishing, amending, or revoking the tolerance, issue a proposed rule to do the same, or deny the petition. (21 U.S.C. 346a(d)(4)). Once EPA takes final action on the petition by either establishing, amending, or revoking the tolerance or denying the petition, any affected party has 60 days to file objections with EPA and seek an evidentiary hearing on those objections. (21 U.S.C. 346a(g)(2)). If objections are filed by a party other than the petitioner, EPA is required to serve a copy of any objections on the petitioner. (Id.). EPA's final order on the objections is subject to judicial review. (21 U.S.C. 346a(h)(1)). 4. *Other EPA statutory authority over pesticides* . EPA also regulates pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (“FIFRA”), (7 U.S.C. 136 et seq). While the FFDCA authorizes the establishment of legal limits for pesticide residues in food, FIFRA requires the approval of pesticides prior to their sale and distribution, (7 U.S.C. 136a(a)), and establishes a registration regime for regulating the use of pesticides. FIFRA regulates pesticide use in conjunction with its registration scheme by requiring EPA review and approval of pesticide labels and specifying that use of a pesticide inconsistent with its label is a violation of Federal law. (7 U.S.C. 136j(a)(2)(G)). B. Evaluating the Safety of Tolerances Through the Use of Risk Assessment Including the Use of Safety Factors 1. *In general* . The process EPA follows in evaluating FFDCA petitions to establish tolerances and in determining the safety of the petitioned-for tolerances includes two steps. First, EPA determines an appropriate residue level value for the tolerance taking into account data on levels that can be expected in food. Second, EPA evaluates the safety of the tolerance relying on toxicity and exposure data and guided by the statutory definition of “safe” and the statutory requirements concerning risk assessment. Only on completion of the second step can EPA make a decision on whether a tolerance may be established. Below, EPA explains in detail, the reasons for this approach. 2. *Choosing a tolerance value* . In the first step of the tolerance evaluation process (choosing a tolerance value), EPA reviews data from experimental crop field trials in which the pesticide has been used in a manner, consistent with the draft FIFRA label, that is likely to produce the highest residue in the crop in question (e.g., maximum application rate, maximum number of applications, minimum pre-harvest interval between last pesticide application and harvest). (Refs. 2 and 3). These crop field trials are generally conducted in several fields at several geographical locations. (Ref. 3 at pages 5, 7, and Tables 1 and 5). Several samples are then gathered from each field and analyzed. (Id. at 53). Generally, the results from such field trials show that the residue levels for a given pesticide use will vary from as low as non-detectable to measurable values in the parts per million
(ppm)range with the majority of the values falling at the lower part of the range. EPA uses a statistical procedure to analyze the field trial results and identify the upper bound of expected residue values. This upper bound value is used as the tolerance value. (Ref. 4). (As discussed below, the safety of the tolerance value chosen is separately evaluated.). There are three main reasons for closely linking tolerance values to the maximum value that could be present from maximum label usage of the pesticide. First, EPA believes it is important to coordinate its actions under the two statutory frameworks governing pesticides. (See 61 FR 2378, 2379, January 25, 1996). It would be illogical for EPA to set a pesticide tolerance under the FFDCA without considering what action is being taken under FIFRA with regard to registration of that pesticide use. (Cf. 40 CFR 152.112(g) (requiring all necessary tolerances to be in place before a FIFRA registration may be granted)). In coordinating its actions, one basic tenet that EPA follows is that a grower who applies a pesticide consistent with the FIFRA label directions should not run the risk that his or her crops will be adulterated under the FFDCA because the residues from that legal application exceed the tolerance associated with that use. To further this goal, crop field trials require application of the pesticide in the manner most likely to produce maximum residues. Second, choosing tolerance values based on FIFRA label rates helps to ensure that tolerance levels are established no higher than necessary. If tolerance values were selected solely in consideration of health risks, in some circumstances, tolerance values might be set so as to allow much greater application rates than necessary for effective use of the pesticide. This could encourage misuse of the pesticide. Finally, closely linking tolerance values to FIFRA labels helps EPA to police compliance with label directions by growers because detection of an overtolerance residue is indicative of use of a pesticide at levels, or in a manner, not permitted on the label. 3. *The safety determination—risk assessment* . Once a tolerance value is chosen, EPA then evaluates the safety of the pesticide tolerance using the process of risk assessment. To assess risk of a pesticide, EPA combines information on pesticide toxicity with information regarding the route, magnitude, and duration of exposure to the pesticide. In evaluating a pesticide's potential hazards (e.g., liver effects, carcinogenicity), EPA examines both short-term (e.g., “acute”) and longer-term (e.g., “chronic”) adverse effects from pesticide exposure. (Ref. 2 at 8-10). EPA also considers whether the “effect” has a threshold - a level below which exposure has no appreciable chance of causing the adverse effect. For non-threshold effects, EPA assumes that any exposure to the substance increases the risk that the adverse effect may occur. At present, EPA only considers one adverse effect, the chronic effect of cancer, to potentially be a non-threshold effect. (Ref. 2 at 8-9). Not all carcinogens, however, pose a risk at any exposure level (i.e., “a non-threshold effect or risk”). Advances in the understanding of carcinogenesis have increasingly led EPA to conclude that some pesticides that cause carcinogenic effects only cause such effects above a certain threshold of exposure. Once the hazard for a durational scenario is identified, EPA must determine the toxicological level of concern and then compare estimated human exposure to this level of concern. This comparison is done through either calculating a safe dose in humans (incorporating all appropriate safety factors) and expressing exposure as a percentage of this safe dose (the reference dose (“RfD”) approach) or dividing estimated human exposure into an appropriately protective dose from the relevant studies (the margin of exposure (“MOE”) approach). How EPA determines the level of concern and assesses risk under these two approaches is explained in more detail below. EPA's general approach to estimating exposure is also briefly discussed. a. *Levels of concern and risk assessment* —i. *threshold effects* . In assessing the risk from a pesticide's threshold effects, EPA evaluates an array of toxicological studies on the pesticide. In each of these studies, EPA attempts to identify the lowest observed adverse effect level (“LOAEL”) and the next lower dose at which there are no observed adverse affect levels (“NOAEL”). Generally, EPA will use the lowest NOAEL from the available studies, taking into account the route and duration of exposure, as a starting point in estimating the level of concern for humans for a given exposure scenario (e.g., acute oral exposure). This selected NOAEL is usually referred to as the Point of Departure. In estimating and describing the level of concern, however, the Point of Departure is at times manipulated differently depending on whether the risk assessment addresses dietary or non-dietary exposures. (Refs. 2 at 3-8; 5 at 8, 52-53; and 6). For dietary risks, EPA uses the Point of Departure to calculate a safe dose or RfD. The RfD is calculated by dividing the Point of Departure by applicable safety or uncertainty factors. Typically, a combination of safety or uncertainty factors providing a hundredfold
(100X)margin of safety is used: 10X to account for uncertainties inherent in the extrapolation from laboratory animal data to humans and 10X for variations in sensitivity among members of the human population as well as other unknowns. Further, to account for deficiencies in the database or the results seen in the database, EPA has traditionally added additional safety factors on a case-by-case basis. The FQPA amendments to FFDCA section 408 require an additional safety factor of 10X to protect infants and children (to address data completeness and pre- and post-natal toxicity concerns), unless reliable data support selection of a different factor. To some extent, the FQPA safety factor addresses concerns related to the factors driving EPA's traditional use of additional safety factors. In implementing FFDCA section 408, EPA's Office of Pesticide Programs, also calculates a variant of the RfD referred to as a Population Adjusted Dose (“PAD”). A PAD is the RfD divided by any portion of the FQPA children's safety factor that does not correspond to one of the traditional additional safety factors used in general Agency risk assessment. (Ref. 5 at 13-16). The reason for calculating PADs is so that other parts of the Agency, which are not governed by FFDCA section 408, can, when evaluating the same or similar substances, easily identify which aspects of a pesticide risk assessment are a function of the particular statutory commands in FFDCA section 408. Today, RfDs and PADs are generally calculated for both acute and chronic dietary risks although traditionally a RfD or PAD was only calculated for chronic dietary risks. Throughout this document general references to EPA's calculated safe dose are denoted as a RfD/PAD. To quantitatively describe risk using the RfD/PAD approach, estimated exposure is expressed as a percentage of the RfD/PAD. Dietary exposures lower than 100 percent of the RfD/PAD are generally not of concern. For non-dietary, and often for combined dietary and non-dietary, risk assessments of threshold effects, the toxicological level of concern is not expressed as a safe dose or RfD/PAD but rather as the margin of exposure
(MOE)that is necessary to be sure that exposure to a pesticide is safe. To calculate the MOE for a pesticide for a given exposure scenario, the expected human exposure to the pesticide is divided into the dose identified as the Point of Departure. A safe MOE is generally considered to be a margin at least as high as the product of all applicable safety factors for a pesticide. For example, if a pesticide needs a 10X factor to account for interspecies differences, a 10X factor for intraspecies differences, and a 10X FQPA children's safety factor, the safe or target MOE would be a value of at least 1,000. In contrast to the RfD/PAD approach, the higher the pesticide's MOE, the safer the pesticide would be considered. Accordingly, if the target MOE for a pesticide is 1,000, MOE's for that pesticide exceeding 1,000 would generally not be of concern. Like RfD/PADs, specific MOEs are calculated for exposures of different durations. For non-dietary exposures, EPA typically examines short-term, intermediate-term, and long-term exposures. Additionally, non-dietary exposure often involves exposures by various routes including dermal, inhalation, and oral. The RfD/PAD and MOE approaches are fundamentally equivalent. For a given risk and given exposure of a pesticide, if the pesticide were found to be safe under a RfD/PAD analysis it would also pass under the MOE approach, and vice-versa. ii. *Non-threshold effects* . For risk assessments for non-threshold effects, EPA does not use the RfD/PAD or MOE approach if quantitation of the risk is deemed appropriate. Rather, EPA calculates the slope of the dose-response curve for the non-threshold effects from relevant studies using a model that assumes that any amount of exposure will lead to some degree of risk. The slope of the dose-response curve can then be used to estimate the probability of occurrence of additional adverse effects as a result of exposure to the pesticide. For non-threshold cancer risks, EPA generally is concerned if the probability of increased cancer cases exceed the range of 1 in 1 million. b. *Estimating human exposure* . Equally important to the risk assessment process as identifying hazards and determining the toxicological level of concern is estimating human exposure. Under FFDCA section 408, EPA is concerned not only with exposure to pesticide residues in food but also exposure resulting from pesticide contamination of drinking water supplies and from use of pesticides in the home or other non-occupational settings. (See 21 U.S.C. 346a(b)(2)(D)(vi)). There are two critical variables in estimating exposure in food: i. the types and amount of food that is consumed; and ii. the residue levels in that food. Consumption is estimated by EPA based on scientific surveys of individuals' food consumption in the United States conducted by the U.S. Department of Agriculture. (Ref. 2 at 12). Information on residue levels comes from a range of sources including crop field trials; data on pesticide reduction due to processing, cooking, and other practices; information on the extent of usage of the pesticide; and monitoring of the food supply. (Id. at 17). In assessing exposure from pesticide residues in food, EPA, for efficiency's sake, follows a tiered approach in which it, in the first instance, conducts its initial, screening-level exposure assessment using the worst case assumptions that 100 percent of the crop in question is treated with the pesticide and 100 percent of the food from that crop contains pesticide residues at the tolerance level. (Id. at 11). When such an assessment shows no risks of concern, EPA's resources are conserved because a more complex risk assessment is unnecessary and regulated parties are spared the cost of any additional studies that may be needed. If, however, a first tier assessment suggests there could be a risk of concern, EPA then attempts to refine its exposure assumptions to yield a more realistic picture of residue values through use of data on the percent of the crop actually treated with the pesticide and data on the level of residues that may be present on the treated crop. These latter data are used to estimate what has been traditionally referred to by EPA as “anticipated residues.” Use of percent crop treated data and anticipated residue information is appropriate because EPA's worst case assumptions of 100 percent treatment and residues at tolerance value significantly overstate residue values. (72 FR 52112, July 18, 2007; 71 FR 43906, 43909-43910, August 2, 2006). In estimating pesticide exposure levels in drinking water, EPA most frequently uses mathematical water exposure models rather than pesticide-specific monitoring data. (69 FR 30042, 30058, May 26, 2004). EPA's models are based on extensive monitoring data and detailed information on soil properties, crop characteristics, and weather patterns. These models calculate estimated environmental concentrations of pesticides using laboratory data that describe how quickly the pesticide breaks down to other chemicals and how it moves in the environment (i.e., does it bind to the soil or is it highly water soluble). Although computer modeling provides an indirect estimate of pesticide concentrations, these concentrations can be estimated continuously over long periods of time, and for places that are of most interest for any particular pesticide. Modeling is a useful tool for characterizing vulnerable sites, and can be used to estimate peak concentrations from infrequent, large storms. Whether EPA assesses pesticide exposure in drinking water through monitoring data or modeling, EPA uses the higher of the two values from surface and ground water in assessing overall exposure to the pesticide. In most cases, pesticide residues in surface water are significantly higher than in ground water. Generally, in assessing residential exposure to pesticides, EPA relies on its Residential Standard Operating Procedures (“SOPs”). (Ref. 7). The SOPs establish models for estimating application and post-application exposures in a residential setting where pesticide-specific monitoring data is not available. SOPs have been developed for many common exposure scenarios including pesticide treatment of lawns, garden plants, trees, swimming pools, pets, and indoor surfaces including crack and crevice treatments. The SOPs are based on existing monitoring and survey data including information on activity patterns, particularly for children. Where available, EPA relies on pesticide-specific data in estimating residential exposures. C. Children's Safety Factor Policy As part of implementation of the major changes to FFDCA section 408 included in the FQPA, EPA has issued a number of policy guidance documents addressing critical science issues. On January 31, 2002, EPA released its science policy guidance on the children's safety factor. (Ref. 5) [This policy is hereinafter referred to as the “Children's Safety Factor Policy”]. The Children's Safety Factor Policy emphasizes throughout that EPA interprets the children's safety factor provision as establishing a presumption in favor of application of an additional 10X safety factor for the protection of infants and children. (Id. at 4, 11, 47, A-6). Further, the policy notes that the children's safety factor provision permits a different safety factor to be substituted for this default 10X factor only if reliable data are available to show that the different factor will protect the safety of infants and children. (Id.). Given the wealth of data available on pesticides, however, the policy indicates a preference for making an individualized determination of a protective safety factor if possible. (Id. at 11). The policy states that use of the default factor could under- or over-protect infants and children due to the wide variety of issues addressed by the children's safety factor. (Id.). Further, the policy notes that “[i]ndividual assessments may result in the use of additional factors greater or less than, or equal to 10X, or no additional factor at all.” (Id.). In making pesticide-specific assessments regarding the magnitude of the children's safety factor, the policy stresses the importance of focusing on the statutory language that ties the children's safety factor to concerns regarding potential pre- and post-natal toxicity and the completeness of the toxicity and exposure databases. (Id. at 11-12). As to the completeness of the toxicity database, the policy recommends use of a weight-of-the-evidence approach which considers not only the presence or absence of data generally required under EPA regulations and guidelines but also the availability of “any other data needed to evaluate potential risks to children.” (Id. at 20). The policy indicates that the principal inquiry concerning missing data should center on whether the missing data would significantly affect calculation of a safe exposure level. (Id. at 22; accord 67 FR 60950, 60955, September 27, 2002) (finding no additional safety factor necessary for triticonazole despite lack of developmental neurotoxicity (“DNT”) study because the “DNT [study] is unlikely to affect the manner in which triticonazole is regulated.”)). When the missing data are data above and beyond general regulatory requirements, the policy states that the weight of evidence would generally only support the need for an additional safety factor where the data “is being required for ‘cause,’ that is, if a significant concern is raised based upon a review of existing information, not simply because a data requirement has been levied to expand OPP's general knowledge.” (Ref. 5 at 23). As to potential pre- and post-natal toxicity, the Children's Safety Factor Policy lists a variety of factors that should be considered in evaluating the degree of concern regarding any identified pre- or post-natal toxicity. (Id. at 27-31). As with the completeness of the toxicity database, the policy emphasizes that the analysis should focus on whether any identified pre- or post-natal toxicity raises uncertainty as to whether the RfD/PAD is protective of infants and children. (Id. at 31). Once again, the presence of pre- or post-natal toxicity, by itself, is not regarded as determinative as to the children's safety factor. Rather, the policy stresses the importance of evaluating all of the data under a weight-of-evidence approach focusing on the safety of infants and children. (Id.). In evaluating the completeness of the exposure database, the policy explains that a weight-of-the-evidence approach should be used to determine the confidence level EPA has as to whether the exposure assessment “is either highly accurate or based upon sufficiently conservative input that it does not underestimate those exposures that are critical for assessing the risks to infants and children.” (Id. at 32). EPA describes why its methods for calculating exposure through various routes and aggregating exposure over those routes generally produce conservative exposure estimates - i.e. health-protective estimates due to overestimation of exposure. (Id. at 40-43). Nonetheless, EPA emphasizes the importance of verifying that the tendency for its methods to overestimate exposure in fact were adequately protective in each individual assessment. (Id. at 44). IV. The Challenged Tolerances Boscalid is a fungicide used both on agricultural food crops as well as turf. It has a wide variety of agricultural uses including berries, nuts, soybeans, and various vegetables. (40 CFR 180.589(a)). Tolerances have also been established to cover inadvertent residues on various other crops as a result of rotation of these crops onto fields previously treated with boscalid. (40 CFR 180.589(d)). On December 20, 2006, EPA promulgated new boscalid tolerances for residues in or on leafy greens crop subgroup 4A, except head and leaf lettuce, and leafy petioles crop subgroup 4B. (71 FR 76185, December 20, 2006). In promulgating these tolerances, EPA assessed the risk from boscalid based on aggregate boscalid exposure. Animal studies indicated that repeat dosing with boscalid resulted in effects in the liver and/or thyroid in various species. Mechanistic studies indicated that the thyroid effects were derivative of enzymatic effects on the liver. (Ref. 8 at 4). The chronic RfD/PAD was based on the results of three studies that showed similar effects at similar levels. (Id. at 23-24). The boscalid database showed no effects that were attributable to a single dose, and thus boscalid was deemed not to pose an acute risk. Testing involving *in utero* and/or post-natal exposure of animals showed no developmental or reproductive effects; however, this testing resulted in some findings of qualitative or quantitative sensitivity with regard to body weight effects in the young. EPA concluded there was low concern regarding these sensitivity findings for various reasons including that clear NOAELs were identified for these effects and the effects were transient in nature or inconsistent. EPA assessed exposure to boscalid in food relying on the worst case assumption that boscalid residues in all crops to which boscalid may be legally applied had residues at the tolerance level. EPA concluded that chronic exposures to boscalid did not raise safety concerns because the most highly exposed population subgroup, children 1-2 years old, had exposures below the PAD or safe dose (exposure was at 38 percent of the PAD). (71 FR 76188). Short-term exposures from golf course turf was also judged to be safe having a MOE of 1,400. (Id.). EPA concluded the cancer risk posed by boscalid was negligible given the weak evidence of carcinogenicity in animal studies. (Id. at 76189). In conducting these assessments, EPA determined that the children's safety factor could be removed because the database was complete, there was low concern for increased sensitivity in the young, and exposure had been estimated in a conservative fashion. (Id. at 76188). V. NRDC's Objections On February 20, 2007, NRDC filed objections to the December 2006 rule establishing tolerances for boscalid on various leafy greens. (Ref. 1). On May 21, 2007, NRDC supplemented and expanded its objections by filing comments during the comment period held by EPA on NRDC's initial objections. (Ref. 9). NRDC's objections have two main thrusts:
(1)that EPA erred in removing the children's safety factor given the finding of that young animals had increased sensitivity to boscalid; and
(2)that EPA's decision is arbitrary and capricious due to a failure to adequately explain its reasons for removing the children's safety factor and because EPA's selection of NOAELs and the RfD/PAD “are clearly contrary to the data.” (Ref. 1). With regard to increased sensitivity in young animals, NRDC relied in its objections principally on the EPA finding in the DNT study that rat pups had decreased body weight and decreased body weight gain at a dose of 147 milligrams/kilogram of body weight/day (mg/kg/day) whereas no effects were seen in the maternal animals even at the highest dose tested (1,442 mg/kg/day). Further, NRDC cites the rat reproduction study as evidencing increased sensitivity in rat pups. Given this sensitivity, NRDC argues that it was wrong for EPA to rely on a study on adult animals to set the RfD/PAD without retaining the children's safety factor. In addition to arguing that EPA did not give proper weight to its findings of increased sensitivity to the young, NRDC claims that EPA analyzed the data in several studies in a manner that understates the sensitivity of the young and has selected a RfD/PAD that is under-protective of the young. (NRDC's arguments on these points are presented in more detail in Unit VII.A. below.). EPA's allegedly improper analysis is cited as grounds for retaining the children's safety factor. NRDC claims that if EPA had retained the children's safety factor it could not have concluded that the boscalid tolerances are safe. NRDC makes no new arguments to justify its claim that EPA's decision is arbitrary and capricious; rather, NRDC merely cross-references its earlier assertions regarding EPA's interpretation of science data. In its comments on its objections, NRDC expands on these arguments. First, it argues that EPA erred in discounting the seriousness of the increased sensitivity in the DNT and rat reproduction studies. NRDC claims that EPA's analysis is based on nothing more than speculation. (Ref. 9 at 2-4). Second, NRDC cites a third study as showing sensitivity in young animals, the rabbit developmental study, and argues similarly that EPA has relied on nothing more than speculation to conclude that the demonstrated sensitivity is of low concern. Finally, NRDC provides greater detail in support of its argument that EPA's selection of a RfD/PAD for boscalid is not protective of children and does not justify removal of the children's safety factor. VI. Public Comments Upon receipt of the objections, EPA provided a copy of the objections to the tolerance petitioner, BASF Corporation, as required by the statute. Further, on March 28, 2007, EPA published a notice of the availability of the objections and established a 60-day comment period. (72 FR 14551, March 28, 2007). Other than from BASF, EPA received significant comments only from NRDC - commenting on its own objections. BASF's comments stressed that a complete database had been submitted on boscalid including neurotoxicity studies that went beyond the core toxicology database requirements. In addition, BASF asserted that these studies showed “no toxicologically meaningful effects [in young animals] were observed at a dose below one that produced toxicity to the parental animals.” (Ref. 10 at 2). BASF contended that effects in rat pups in the DNT and the two-generation reproduction study that occurred at doses lower than effects in maternal animals were small and/or transient decreases in pup body weight. (Id.). Because NRDC's comments on its own objections were a supplementation of its objections, these comments were provided to BASF and BASF was given a 30-day period for response. (Ref. 11). As to NRDC's new arguments concerning sensitivity in the young, BASF asserts that the data did not support that conclusion. As regards the two-generation reproduction study and the DNT, BASF notes that, although toxicity in the parental animals was not seen in the DNT study and was seen only at the high dose in the reproduction study, in the chronic/carcinogenicity study in rat, where systematic toxicity is examined more thoroughly, adverse effects were seen at doses corresponding to the mid and high doses in the DNT and reproduction studies. Thus, BASF concludes that the findings of adverse effects in the young at the mid and high doses in the DNT and reproduction studies do not show increased sensitivity in the young. As to the rabbit developmental study, BASF argues that, because the effects on the fetuses (increased number of abortions) occurred at a dose that showed the maternal animals were under stress (decreased weight gain), the study does not show increased sensitivity in the fetuses. According to BASF, “[t]he rabbit is prone to spontaneously abort as a response to maternal stress, and feed restriction alone during the gestational period may trigger abortions in rabbits.” (Id. at 3). Finally, BASF defends EPA's use of the NOAEL from the chronic dog study as the Point of Departure for setting the cRfD/PAD by presenting a “benchmark dose” analysis of the relevant studies. Benchmark dose analysis involves fitting a mathematical model to the dose response data for the purpose of estimating the threshold effect level (i.e., the no adverse effect level) reflecting a selected benchmark response (e.g., 5%, 10%). BASF's benchmark dose analysis revealed that the NOAEL from the chronic dog study was lower than the benchmark dose from DNT and two-generation reproduction studies. VII. EPA's Response to the Objections For the reasons stated below, EPA denies each of NRDC's objections. A. NRDC's Challenge to EPA's Children's Safety Factor Determination NRDC contends that EPA's decision to remove the children's safety factor was erroneous based on
(1)the legal argument that whenever EPA identifies increased sensitivity in the young it is required to retain the full 10X children's safety factor; and
(2)the scientific claim that EPA did not have a reasoned basis for its conclusion that the sensitivity identified in animal studies was of low concern in evaluating whether the 10X children's safety factor should be retained or a different factor selected. Before reaching the merits of these arguments, one preliminary matter needs to be addressed. In a prior order on an objection to EPA's removal of the children's safety factor as to different pesticides, EPA denied the objection where retention of the children's safety factor would not have altered EPA's conclusion on the pesticide's safety (72 FR 39318, 39323-39324, July 18, 2007). For boscalid, the retention/removal decision appears to be critical to the safety determination because EPA concluded that chronic exposure to boscalid for the highest exposed population subgroup is at 38 percent of the RfD/PAD. If no other change is made to the boscalid risk assessment other than retaining the 10X children's safety factor, then the calculation that boscalid exposure uses 38 percent of the RfD/PAD for the most highly-exposed subgroup would increase by a factor of 10. Because of the conservativeness of the exposure assessment for boscalid (assuming all foods that may be legally treated bear tolerance level residues), however, EPA strongly suspects that a more realistic exposure assessment will not show a risk of concern. Exposure refinements from the worst case assumptions of all foods containing tolerance level residues generally reduce exposure estimates by an order of magnitude or more. (70 FR 46706, 46732, August 10, 2005). Nonetheless, because EPA has not completed a revised risk assessment for boscalid at this time, it will address in this order the substance of NRDC's challenge to EPA's decision on the children's safety factor. It should be noted that EPA's decision on the children's safety factor for boscalid relied in part on the conservativeness of EPA's exposure assessment. This consideration continues to be relevant, even if, at this point, it does obviate NRDC's objection entirely. 1. *NRDC's legal argument* . NRDC argues that, because section 408 “requires that the additional FQPA tenfold safety factor ‘shall be applied' to ‘take into account' ‘potential pre- and post-natal toxicity,” . . . [t]he clear evidence that juveniles are significantly more vulnerable than adults compels EPA to retain or increase the default FQPA tenfold safety factor for boscalid.” (Ref. 1 at 3). On repeated occasions EPA has rejected the interpretation that the children's safety factor provision mandates that the absence of a particular study or a finding of pre- or post-natal toxicity or increased sensitivity in the young removes EPA's discretion to choose a different safety factor. (72 FR 52108, 52115-52117, September 12, 2007; 71 FR 43906, 43919, August 2, 2006). EPA explained its rationale recently in responding to NRDC objections which made precisely the same argument in this case: The statute does direct EPA to consider “susceptibility of infants and children” to pesticides. (21 U.S.C. 346a(b)(2)(C)(i)(II)). It also states that an additional safety factor to protect infants and children shall be applied “to take into account potential pre- and post-natal toxicity . . . .” (21 U.S.C. 346a(b)(2)(C)). Nonetheless, in clear and unmistakable language, Congress decreed that, “[n]otwithstanding such requirement for an additional margin of safety” to take into account potential pre- and post-natal toxicity, EPA is authorized to choose a different safety factor if EPA has reliable data showing a different factor is safe. (Id.). Interpreting the statute as creating a rigid, per se rule that the identification of sensitivity in the young removes EPA's discretion to choose a different safety factor is inconsistent with this language and the flexibility granted to the Agency. (72 FR at 52117). NRDC has raised no arguments in its current objections which convince EPA to vary from its long-held interpretation. 2. *NRDC's scientific argument* . NRDC makes five claims as to why the evidence on increased sensitivity in the young is of such significance that it was inappropriate for EPA to remove the children's safety factor. NRDC also argues that an alleged lack of reliable data supporting EPA's derivation of the boscalid RfD/PAD demonstrates that it was unlawful to remove the children's safety factor. Each claim is addressed in turn below. a. *The degree of increased sensitivity seen in the DNT* . NRDC claims that adverse effects on auditory startle reflex were seen at all doses in the offspring in the DNT study and thus the dose EPA identified as a NOAEL for the offspring (14 mg/kg/day) is actually a LOAEL. According to NRDC, this demonstrates a higher degree of sensitivity in the offspring. NRDC notes that a draft EPA assessment of the DNT study concluded that there were adverse effects on the auditory startle reflex in offspring at all tested doses. The final EPA review of the DNT study took the opposite position: that there was not a significant effect on the auditory startle reflex at any dose. NRDC argues that EPA's final review is flawed because EPA misused data on the historical level of the auditory startle reflex in rat controls in other studies (“historical control data”). According to NRDC, EPA erred by comparing historical control data to the results in the treated animals in the boscalid DNT study to determine if the treated animals varied from control animals generally. NRDC argues that the only valid use of historical control data is as a check on whether there is a problem with the controls in a particular study. EPA disagrees with NRDC's analysis and reaffirms its conclusion that boscalid did not elicit an adverse effect on auditory startle reflex in the DNT study. In its initial analysis of the DNT, an EPA reviewer concluded that there were treatment-related decreases in auditory startle reflex at all doses on post-natal-day (“PND”) 24. This finding was based on a statistically significant decrease in auditory startle reflex in males at both the low and high doses in the first block of five trials and for the average effect over all trials. The average decrease was greater in the low dose group (24%) than the high dose group (19%). The mid-dose group had a slightly lower decrease of 15%. In females, a statistically significant effect was only seen in the second block of the low and mid-dose groups but no such effect was seen for the average across blocks. Again, there was no dose-response effect in that greater decreases were seen at the low dose than at the mid or high dose. No statistically significant effects on auditory startle reflex were seen on PND 60. Noting the “limitations” in the data, the EPA reviewer nonetheless tentatively found a treatment-related effect at all doses. In response to this tentative conclusion, the boscalid registrant submitted historical control data on auditory startle reflex and data concerning one male pup that died on PND 25. After examining the historical control data, EPA concluded that the auditory startle reflex of the controls from the boscalid DNT study were similar to historical controls and thus the controls from the boscalid study “should be considered the primary source for analysis and consideration” for this study. (Ref. DER at 30). As to the rat which died, EPA concluded that it was suffering from an underlying illness unrelated to treatment and removed its data from the study. As a result, none of the individual block trials nor the average from all trials for males evidenced a statistically significant decrease in auditory startle reflex at PND 24. EPA also reanalyzed the statistical significance of the results for the females and found a statistically significant effect only at the low dose for the second block. Given the revised finding of a statistically significant effect in only one block trial (out of five) at one dose (out of three) in one sex on one day of testing (out of two) and the lack of a dose response (effects only at the low dose), EPA concluded that there was no treatment-related effect on auditory startle reflex. NRDC's objection here is denied. As a preliminary matter, EPA would note that it disagrees with NRDC's claim that historical control data can only be used for the narrow purpose of evaluating the fitness of a study's controls. (Refs. 12a, 12b, and 12c). This disagreement, however, is beside the point because for the boscalid DNT study EPA used historical control data in precisely the manner that NRDC argues they should be used. EPA's review of the DNT specifically found that “[h]istorical control data provided indicated that the mean startle amplitude on PND 24 for the current study of [boscalid] was similar to the control means of the submitted studies on PND 24. Therefore the analysis of this group's relation to treatment groups is valid and should be considered the primary source for analysis and evaluation.” (Ref. 13 at 30). Finally, EPA's conclusion that the DNT study showed no treatment-related effect on auditory startle reflex was based upon a reasonable evaluation of the data, as demonstrated above. b. *The sensitivity of DNT Study* . NRDC claims that the DNT study is an insensitive study because it involves examination of only one male and one female pup per litter and that therefore EPA should have attached more significance to the finding of increased sensitivity in the young in that study. NRDC also criticizes the statistical analysis of the DNT study for only including probability values (“p-values”) representing confidence levels of 95 percent (p-value of 0.05) and 99 percent (p-value of 0.01). (Basically, a p-value defines the probability that an observed difference between a control group and a treatment group is based on chance alone.). NRDC argues that rather than analyze the data against the p-values of 0.05 and 0.01, EPA should calculate the “actual p-value statistic,” and thus EPA could use its “expert judgment on the significance of the findings, given the limitations of the study.” (Ref. 1 at 5). EPA believes that the significance attached to findings of sensitivity in a DNT study should be driven primarily by an evaluation of the results of the study itself. EPA would note that the development and design of the DNT study underwent an exhaustive independent scientific peer review as well as public comment process. (Ref. 14). This process included multiple reviews by EPA's FIFRA Scientific Advisory Panel and public comment opportunities as well as a scientific workshop involving outside experts organized expressly to evaluate developmental neurotoxicity testing issues. (Id.). NRDC's criticisms of use of reporting statistical significance at the 95 and 99 percent confidence levels are misplaced. Use of p-values of 0.01 and 0.05 to document statistically significant differences between treated and control animal groups is a long-established practice in the scientific community. (Refs. 15a, 15b, 15c, 15d, and 15e). EPA can calculate different levels of statistical confidence if for some reason the data suggest that may be valuable; however, in EPA's judgment no such reasons were present in the circumstances of the boscalid DNT study. c. * Weight-of-the-evidence evaluation of the two-generation reproduction study in rats* . NRDC argues that EPA undervalues the importance of increased sensitivity identified in the two generation reproduction study in rats based on nothing more than speculation. According to NRDC, EPA was just “guess[ing]” when it stated that: “The degree of concern is also low for the quantitative evidence of susceptibility seen in the 2-generation reproduction study in rats because the decreases in body weight and body weight gains were seen primarily in the [second] generation. These *may have been* due to exposure of the parental animals to high doses (above the Limit Dose).” (Ref. 9 at 2 (citing to 76 FR 76188) (emphasis added by NRDC)). NRDC also suggests that EPA's “speculation” is “nonsensical” because if the second generation pups had effects due to high dose exposures of the parents, then these effects should have been seen in the first generation pups because their parents had the same high dose exposures. In comments on NRDC's objections, BASF argues that young animals are not more sensitive to boscalid than adult animals given that adult animals in the chronic/carcinogenicity study in the rat experienced adverse effects at similar dose levels as the pups in the two generation rat study. BASF makes the same contention with regard to the DNT study. (See Unit VII.A.2.d., below). EPA does not believe that the sensitivity evidenced in the pups in the two-generation reproduction requires retention of the 10X children's safety factor. As discussed in detail in Unit VII.A.2.f., the NOAEL from the chronic dog study used for the Point of Departure in setting the chronic RfD/PAD for the liver effects is protective of the body weight effects seen in the second generation male pups at mid and high doses in the two-generation reproduction study. EPA disagrees with NRDC that it was somehow improper to take into account that the body weight effects in the pups in the two-generation reproduction study were only seen in males and only in the second generation. These factors bear on significance of the effects seen. Effects seen in only one sex and only after dosing for two generations are generally regarded as less significant than effects seen in both sexes and in both generations of a two-generation study. Moreover, there is other evidence from the study suggesting that body weight effects in the young were not entitled to great weight in EPA's weight-of-the-evidence analysis. First, absolute body weight and bodyweight gain of the male F <sup>2</sup> offspring of treated dams were similar to those of the offspring of the control dams at birth. Birth is a more sensitive time point to indicate susceptibility than subsequent time periods. (Refs. 16a, 16b, and 16c). Second, there was a lack of consistency in the observed body weight decreases (i.e, decreased on days 7 and 21 but not on days 4 and 17). (Ref. 17 at 20). EPA believes these factors are important to informing its expert judgment regarding the level of concern regarding, or the significance of, the increased sensitivity observed in this study. In any event, EPA's determination that the chronic RfD/PAD is protective of the pup effects seen in the reproduction study is alone sufficient to allay any concerns regarding increased sensitivity and pre- and post-natal toxicity raised by the two-generation reproduction study. NRDC places special emphasis on EPA's suggestion that the body weight effect may be due to the very high dose given the maternal animals. EPA's statement on this issue was in error because, as noted, the body weight effects were seen at both the mid and high doses in the study in the second generation pups. Nonetheless, for the reasons described above, identification of a clear NOAEL for body weight effects and limited nature of the body weight effects (e.g., one sex only, inconsistent findings at the mid dose), EPA concludes that the chronic RfD/PAD based on a safety factor of 100X is safe for infants and children. EPA does not agree that BASF has made an appropriate comparison of the results of the two-generation reproduction study and the chronic/carcinogenicity study given the substantial difference in time of exposure to boscalid in the two studies. d. *Weight-of-the-evidence evaluation of the DNT Study* . NRDC argues that EPA errs in downplaying the significance of the decreased weight gain in pups seen in the DNT. NRDC states that EPA found there to be low concern for the decreases in pup body weight on post-natal days 1-4 because no effects on body weight were seen at any other time and the effects only occurred when the maternal animals were receiving an extremely high dose (above the Limit Dose) suggesting that pup effects were derivative of effects on the maternal animals. This reasoning is attacked by NRDC as mere speculation. NRDC claims that “the Agency does not and cannot assert that inadequate weight gain on days 1-4 is an insignificant adverse effect. Any significant reduction in weight gain during early development is potentially harmful and may cause permanent adverse effects.” (Ref. 9 at 3). Further, NRDC states that EPA has presented no empirical evidence to support its conclusion that the high dose to the maternal animals might have been the reason for the pup effect. For similar reasons to those relied upon in rejecting NRDC's arguments concerning the two-generation reproduction study, EPA does not believe that the sensitivity evidenced in the pups in the DNT study requires retention of the 10X children's safety factor. As discussed in detail in Unit VII.A.2.f., the NOAEL from the chronic dog study used for the Point of Departure in setting the chronic RfD/PAD for the liver/thyroid effects is protective of the transient body weight effects seen in the pups at mid dose and the more severe pup body weight effects at the high dose in the DNT study. EPA disagrees with NRDC that it was somehow improper to take into account that the body weight effects in the mid-dose pups were transient in nature - i.e., statistically significant decreases in body weight were seen on post-natal days 1-4 but the animals had recovered by day 11. The severity of an effect aids in evaluation of the dose response curve for a pesticide; in this case, it indicates that mid dose was not far from the actual no adverse effect level. In any event, EPA's determination that the chronic RfD/cPAD is protective of the pup effects seen in the DNT study is alone sufficient to allay any concerns regarding increased sensitivity and pre- and post-natal toxicity raised by the DNT study. NRDC challenges EPA's reasoning that the effects on pups' body weight may be due to the maternal animals being exposed above the Limit Dose. The Limit Dose is regarded as the highest dose possible that can be given an animal without overwhelming its defense mechanisms. As a general matter, EPA does not believe NRDC's argument is well-founded because discounting the weight of effects seen only at or above the Limit Dose is a well-accepted scientific precept. Here, however, EPA erred by mentioning the Limit Dose because effects were present in the pups at the mid dose as well as at the dose that exceeded the Limit Dose. Nonetheless, for the reasons described above, identification of a clear NOAEL for body weight effects and limited nature of the body weight effects (e.g., one sex only, transient nature of effects at the mid dose), EPA concludes that the RfD/PAD based on a safety factor of 100X is safe for infants and children. For the same reason as stated in Unit VII.A.2.c., EPA disagrees with BASF's comparison of the DNT study and the chronic/carcinogenicity study. e. *Weight-of-the-evidence evaluation of the rabbit developmental study* . NRDC claims that EPA wrongfully disregards the qualitative evidence of increased sensitivity seen in the rabbit developmental study. According to NRDC, EPA expressed a low degree of concern for increased abortions or early delivery effects on the young because they were seen only at the Limit Dose and may have been caused by maternal stress. NRDC faults EPA for not providing empirical evidence to support this conclusion and argues that the Limit Dose might not be the maximum tolerated dose for boscalid in rabbits. This type of “speculation,” NRDC claims, cannot meet the “reliable data” requirement for choosing a different children's safety factor. NRDC's claims as to the rabbit developmental study, have even less merit than its arguments as to the two-generation reproduction and DNT studies. Not only is the chronic RfD/PAD for the thyroid effects protective of the qualitative sensitivity seen in the rabbit developmental study but the chronic RfD/cPAD is protective by an order of magnitude of an effect seen only at a “limit dose.” The chronic RfD/PAD is based on a NOAEL from the chronic dog study of 21.8 mg/kg/day as compared to the NOAEL for the fetal effects in the rabbit developmental study of 300 mg/kg/day. The fetal effects (abortions and early delivery) were seen only at the Limit Dose. (Unlike in the two-generation reproduction and DNT studies, adverse effects were only seen in the young at the high dose.). Moreover, the fetal effects were seen only in the presence of adverse effects in the maternal animals. The primary adverse effects in the maternal animals were abortions and early delivery (considered an adverse effect on both maternal animals and fetuses) but the study evidenced decreased food consumption and decreased body weight in the maternal animals as well. Although a definitive conclusion was not reached on whether the food consumption effects were treatment-related, evaluation of the individual animals showed that three of the four does that aborted or delivered early experienced dramatic reductions in food consumption. Given these results, it was reasonable for EPA to take into account its scientific expertise with rabbit toxicology studies which indicated that maternal animals put under stress had a tendency to abort or deliver early. Based on all of this evidence, EPA rejects NRDC's arguments concerning the rabbit developmental study and concludes that the qualitative sensitivity evidenced in the fetuses in the rabbit developmental study does not require retention of the 10X children's safety factor. (Refs. 18 and 19). f. *Derivation of the chronic RfD/PAD* . NRDC claims that EPA erred in its selection of a NOAEL to calculate the chronic RfD/PAD by not relying on the lowest NOAEL from the applicable chronic studies. (Ref. 1 at 5-6). NRDC argues that, because EPA's justification for the RfD/PAD is allegedly nothing more than speculation, EPA lacks the reliable data necessary to remove the children's safety factor. (Ref. 9 at 4-5). EPA relied on three co-critical studies in selecting a NOAEL for the chronic RfD/PAD: chronic toxicity in the rat, carcinogenicity in the rat, and chronic toxicity in the dog. Each of these studies showed liver effects and the rat studies also evidenced secondary effects on the thyroid. The NOAELs for the studies tightly bunched between 21.8 and 30 mg/kg/day. EPA selected the 21.8 mg/kg/day NOAEL from the chronic dog study to calculate the chronic RfD/PAD. EPA considered but rejected lower NOAELs from three other studies: the 90-day subchronic toxicity study in the dog; the two-generation reproduction study in the rat; and the developmental neurotoxicity study. EPA's rationale for not using the NOAELs from these studies was that the lower NOAELs from these studies were an artifact of dose selection given the wide range between NOAEL and LOAEL in the studies and the minimal effects seen at the LOAEL. NRDC challenges EPA's conclusion claiming that EPA has ignored “effects at significantly lower doses in juvenile animals (2-gen repro and DNT).” (Ref. 1 at 4). NRDC also argues that EPA's decision is speculative because
(1)“EPA does not identify any reliable data to support its theory that a 10x differential between NOAELs and LOAELs - as occurred [with the three studies with lower NOAELs] - can never result from well designed and conducted studies;” and
(2)“EPA offers no reliable data to support its assumption that the relationship between the LOAELs and NOAELs across studies with different designs and with different test species must always be the same . . . .” (Ref. 9 at 4). NRDC's arguments are without merit. First, NRDC is wrong to contend that EPA, in setting the chronic RfD/PAD, ignored “effects at significantly lower doses in juvenile animals” in the two-generation reproduction study and the DNT. EPA based the chronic RfD/PAD on the chronic dog study. In that study the lowest dose in which adverse effects were seen was 57.4 mg/kg/day. On the other hand, in the two-generation reproduction study and the DNT, the lowest doses at which adverse effects were seen were 101.2 mg/kg/day and 147 mg/kg/day, respectively. (Ref. 18 at 17). Second, EPA is not contending, nor does its analysis depend on, the supposition that a “10x differential between NOAELs and LOAELs . . . can never result from well designed and conducted studies.” The differential between a study's NOAEL and LOAEL depends on the dose spacing in the study - studies with more and closely-spaced doses are likely to yield a lower differential than studies with fewer and widely-spaced doses. EPA is not arguing that it is inappropriate to design a study with a factor of 10 between doses. Third, EPA is not contending that the relationship between NOAELs and LOAELs across studies must always be the same. Rather, EPA concluded that the data for boscalid indicated that the NOAEL it selected as the Point of Departure for calculating the chronic RfD/PAD would be protective of all effects. In making this conclusion, EPA relied on several factors. First, EPA compared the NOAELs and LOAELs of the six chronic studies that had NOAELs that were relatively close. This exercise is appropriate because the NOAEL from any one study is, in part, an artifact of the dose selection process, and does not identify the no adverse effect level just the level at which no effects were observed in the particular study. In animal testing, animals are generally dosed at three or four different levels. The dose levels are fairly widely spread (generally 2X - 10X) so that there is a good chance of identifying both a NOAEL and a LOAEL. The actual no adverse effect level or lowest adverse effect level will be somewhere between the identified NOAEL and LOAEL. When multiple studies produce results in a similar range, they often can provide valuable information about where the true no adverse effect and lowest adverse effect levels are. The NOAELs and LOAELs for the six studies are presented in Table 1. **Table 1.—Selected Chronic and Subchronic Studies for Boscalid** Study NOAEL male/female (m/f) in mg/kg/day LOAEL m/f in mg/kg/day Chronic toxicity in rats 21.9/30 110/150.3 Carcinogenicity in rats 23/29.7 116.1/155.6 Chronic toxicity in dogs 21.8/22.1 57.4/58.3 Subchronic toxicity in dogs 7.6 78.1 Two-generation reproduction study in rats 10.1/12.3 (offspring) 101.2/123.9 (offspring) DNT in rats 14 (offspring) 147 (offspring) Just based on the dose spread alone, the chronic dog study appears to provide valuable information because it has the tightest spread between NOAEL and LOAEL. Second, EPA considered the effects seen in the studies. The NOAEL/LOAELs for the chronic rat, carcinogenicity rat, and chronic dog studies were all based primarily on effects on the liver and/or thyroid. The other three studies had NOAEL/LOAELs based on decreased body weight and decreased body weight gain. The first three studies also demonstrated body weight effects but at the same or higher doses than the organ effects. Organ effects are generally judged to be of more serious concern than systemic toxicity as shown through body weight effects. Given the heightened concern with the liver and thyroid effects and the fact that body weight effects only occurred at the same or higher doses, evaluation of the effects seen in the studies also supported reliance on the NOAEL from the chronic dog study. Finally, EPA undertook a one-to-one comparison of the chronic dog study with the three studies that had a lower NOAEL. Given that the subchronic dog study was conducted in the same species as the chronic dog study and that the results of the subchronic dog study were fully consistent with the chronic dog study (i.e., based on the chronic dog study it would be expected that 7.6 mg/kg/day would be a NOAEL and 78.1 a LOAEL), the subchronic dog study supported reliance on the NOAEL from the chronic dog study. Further, the strength of the findings at the LOAEL in the two-generation reproduction study and the DNT study, did not suggest that the actual no adverse effect level for the effects seen in these studies is far below the identified LOAEL. In the two-generation reproduction and DNT studies, the body weight effects at the LOAEL were either transient in nature (DNT study), not seen in both sexes (two-generation reproduction study), or not consistently seen post-natally (DNT and two-generation reproduction studies). (See Units VII.A.2.c., VII.A.2.d., and VII.A.2.e.). Given the weight-of-the-evidence, EPA concludes it was reasonable to choose the NOAEL from the chronic dog study in calculating the chronic RfD/PAD. Contrary to NRDC's contention, this decision is not based on speculation but on careful consideration of the entire database - a complete database that provides reliable data on which to choose a safety factor that is protective of the safety of infants and children. In any event, EPA would note that selecting the NOAEL from the DNT study or the two-generation reproduction study would not change the safety conclusion on the boscalid tolerances even without any further refinement of the worst case exposure assumptions relied upon in the tolerance document. EPA estimated exposure was at 38 percent of the chronic RfD/PAD and a lowering of the chronic RfD/PAD by a factor of two due to reliance on the two-generation reproduction study (i.e. using a NOAEL of 10.1 mg/kg/day instead of 21.8 mg/kg/day) would still show worst case exposure to be below the chronic RfD/PAD. BASF, in its comments, presents a benchmark dose analysis of the DNT and two-generation reproduction studies in support of EPA's selection of 21.9 mg/kg/day as the Point of Departure. The benchmark dose calculated by BASF is supportive of EPA's decision in that all of the benchmark doses covering various endpoints in these two studies were higher than 21.8 mg/kg/day. Although BASF's description of the method it used for calculating these benchmark doses appears scientifically appropriate, BASF has not submitted supporting documentation for its calculation and EPA has not independently verified it. 3. *Conclusion on children's safety factor* . EPA disagrees both with NRDC's legal claim that a finding of sensitivity always requires retention of the children's safety factor and factual assertion that the particular evidence of increased sensitivity on boscalid requires such a result. NRDC's legal argument ignores the plain language of the statute. NRDC's factual argument fails to take into account the entire database. EPA has a complete toxicity database for boscalid. The toxicity studies for boscalid show it generally to have low mammalian toxicity and the database reveals no reproductive or developmental concerns, including no developmental neurotoxic concerns. Data involving the testing of young animals did show increased quantitative sensitivity in the young with regard to body weight effects and qualitative sensitivity in one developmental study. Clear NOAELs were identified for all of these effects. Moreover, the body weight effects at the LOAELs in these studies were either transient or inconsistent and qualitative sensitivity occurred at the Limit Dose in the presence of maternal toxicity. EPA reasonably concluded that using the NOAEL from the chronic dog study was protective of all of the effects seen in the developmental and reproduction studies. That the chronic dog study only involved the testing of adult dogs does not raise concerns for the young because, as noted, EPA found the NOAEL from that study to be protective of the effects seen in all studies with the young, and the effects of concern in the dog study, increased liver weights and hepatic enzyme induction, are not common developmental concerns. In any event, when rats were exposed to boscalid pre- and post-natally as well as into adulthood in the two generation reproduction study, increased liver weights were only seen at the Limit Dose. Thus, increased sensitivity to liver effects in the young is not a concern. Finally, EPA has conservatively estimated human exposure to boscalid, relying on worst case exposures in food (assuming all registered crops contain residues at the tolerance level), and conservative models as well as pesticide-specific data in estimating exposure from residues in drinking water and from residential uses. Based on consideration of all of these data, EPA reasonably concluded it had reliable data showing that infants and children would be safe without application of an additional 10X safety factor. B. NRDC's Claim That EPA's Decision is Arbitrary and Capricious NRDC argues that EPA's tolerance decision on boscalid was arbitrary and capricious because
(1)EPA failed to adequately explain its safety factor decision; and
(2)“[t]he NOAELs and cPAD established by EPA for boscalid are clearly contrary to the data . . . .” (Ref. 1 at 7-8). In the section of its objections addressing this claim, NRDC provides nothing in support of its assertion that EPA provided insufficient explanation for its children's safety factor determination. Presumably, NRDC is referring to the aspects of the children's safety factor determination challenged in an earlier portion of its objections and addressed by EPA in Unit VII.A. of this order. Thus, EPA relies on Unit VII.A. as responsive to NRDC's arbitrary and capricious claim as to the children's safety factor decision, and denies the objection for the reasons there stated. Similarly, to the extent NRDC is arguing that EPA's selection of a NOAEL in the DNT study or its selection of the NOAEL from the chronic dog study as the Point of Departure for deriving the chronic RfD/PAD were arbitrary and capricious, EPA denies this objection for the reasons contained in Units VII.A.2.a. and VII.A.2.f. VIII. Regulatory Assessment Requirements As indicated previously, this action announces the Agency's final order regarding objections filed under section 408 of FFDCA. As such, this action is an adjudication and not a rule. The regulatory assessment requirements imposed on rulemaking do not, therefore, apply to this action. IX. Submission to Congress and the Comptroller General The Congressional Review Act, (5 U.S.C. 801 *et seq.* ), as added by the Small Business Regulatory Enforcement Fairness Act of 1996, does not apply because this action is not a rule for purposes of 5 U.S.C. 804(3). X. References 1. NRDC, “Objection To The Establishment Of Tolerances For Pesticide Chemical Residues Of Boscalid Docket Id No. EPA-HQ-OPP-2005-0145” (February 20, 2007). 2. Office of Pesticide Programs, U.S. EPA, “Available Information on Assessing Pesticide Exposure From Food: A User's Guide” (June 21, 2000). 3. U.S. EPA, “Residue Chemistry Test Guidelines: OPPTS 860.1500 Crop Field Trials” (August 1996). 4. Office of Pesticide Programs, U.S. EPA and Pest Regulatory Management Agency, Health Canada, “NAFTA Guidance Document for Guidance for Setting Pesticide Tolerances Based on Field Trial Data ” (September 28, 2005). 5. Office of Pesticide Programs, U.S. EPA, “Determination of the Appropriate FQPA Safety Factor(s) in Tolerance Assessment” (January 31, 2002). 6. Office of Pesticide Programs, U.S. EPA, “The Use of Data on Cholinesterase Inhibition for Risk Assessments of Organophosphorous and Carbamate Pesticides” (August 18, 2000). 7. Office of Pesticide Programs, U.S. EPA, Versar Corporation, “Standard Operating Procedures
(SOPs)for Residential Exposure Assessments” (Draft, December 19, 1997). 8. Office of Prevention, Pesticides and Toxic Substances, U. S. EPA, Memorandum from Yan Donovan to Dennis McNeilly/R.Keigwin, “PP# 1F06313 —Human Health Risk Assessment for New Fungicide BAS 510 F (Common Name: Boscalid) — Proposal for Tolerances for Residues in/on Numerous Crops and Livestock Commodities” (September 8, 2003). 9. NRDC, “Objection to the Establishment of Tolerances for Pesticide Chemical Residues of Boscalid” (May 21, 2007. 10. BASF, “Docket ID Number EPA-HQ-OPP-2005-0145: BASF Response to NRDC Objection to Boscalid Pesticide Tolerances” (May 29, 2007). 11. Email Communication, Bryant Crowe, U.S. EPA to Khalid Akkari, BASF, “Notification: Boscalid - Objections” (July 10, 2007). 12a. W. Kaufmann. 2003. “Current Status of Developmental Neurotoxicity: An Industry Perspective.” *Toxicology Letters* , 140-141; pages 161-169. 12b. U. Deschl, B. Kittle et al. 2002. “The value of historical control data-scientific advantages for pathologists, industry and agencies.” *Toxicologic Patholology* , Vol. 30, number 1, pages 80-87. 12c. J.K. Haseman. 1995. “Data Analysis: Statistical Analysis and Use of Historical Control Data.” *Regulatory Toxicology and Pharmacology* , Vol. 21, pages 52-59. 13. Health Effects Division, Office of Pesticide Programs, US EPA, “Data Evaluation Record: Developmental Neurotoxicity Study - Rat; BAS 910 F”
(Date)(EPA Reviewer: William F. Sette). 14. U.S. EPA, “Response to Petition to Compel the U.S. EPA to Repeal Its Test Guidelines for Developmental Neurotoxicity” (January 3, 2005) (available at “http://docket.epa.gov/edkpub/do /EDKStaffCollection DetailView?objectId =0b0007d480525f44)”. 15a. H.L. Adler and E. B. Roessler 1977. “Introduction to Probability and Statistics.” 6th ed. H. Freeman. New York. 1977. 15b. S. Gad and C.S. Weil. “Statistics and Experimental Design for the Toxicologist.” Telford Press, NJ. 1986. 15c. M. Hollander and D.A. Wolfe. “Non parametric Statistical Methods.” John Wiely & Sons. New York. 1973. 15d. R.R. Holson et al., 2007. “Statistical Issues and Techniques Appropriate for Developmental Neurotoxicity Testing.” *Neurotoxicology and Teratology.* 15e. Haseman, Joseph K. 1981. “Statistical Issues in the Design, Analysis and Interpretation of Animal Carcinogenicity Studies.” In: *Environmental Health Perspectives* , Vol. 58, pp. 385-392. 16a. U.S. Environmental Protection Agency. “Guidelines for Reproductive Toxicity Risk Assessment.” **Federal Register** 61: 56274-56322. 16b. U.S. Environmental Protection Agency. “Guidelines for Developmental Toxicity Risk Assessment.” **Federal Register** . 56: 63798-63826. 16c. “An Evaluation and Interpretation of Reproductive Endpoints For Human Health Risk Assessment.” International Life Science Institute. Health and Environmental Sciences Institute. Developmental and Reproductive Toxicity Committee. November 1998. 17. Health Effects Division, Office of Pesticide Programs, US EPA, “Data Evaluation Record: Reproduction and Fertility Effects Study - Rat; BAS 910 F” (March 23, 2002) (EPA Reviewer: Alan Levy). 18. Office of Prevention, Pesticides and Toxic Substances, U. S. EPA, Memorandum from Alan Levy to Yan Donovan, “BAS 510 F - Report of the Hazard Identification Assessment Review Committee” (March 7, 2003). 19. Health Effects Division, Office of Pesticide Programs, US EPA, “Data Evaluation Record: Prenatal Developmental Toxicity Study - Rabbit; BAS 910 F” (March 23, 2002) (EPA Reviewer: Alan Levy). List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: January 17, 2008. Debra Edwards, Director, Office of Pesticide Programs. [FR Doc. E8-1523 Filed 1-29-08; 8:45 am] BILLING CODE 6560-50-S ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2006-0481; FRL-8341-6] Fluopicolide; Pesticide Tolerance AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. SUMMARY: This regulation establishes a tolerance for residues of fluopicolide, 2,6-dichloro- *N* -[[3-chloro-5-(trifluoromethyl)-2-pyridinyl]methyl]benzamide, as an indicator of combined residues of fluopicolide and its metabolite, 2,6-dichlorobenzamide (BAM), in or on grape at 2.0 parts per million (ppm); grape, raisin at 6.0 ppm; vegetable, cucurbit, group 9 at 0.50 ppm; vegetable, fruiting, group 8 at 1.6 ppm; vegetable, leafy, except brassica, group 4 at 25 ppm; and vegetable, tuberous and corm, subgroup, except potato, 1D at 0.02 ppm. Valent U.S.A. Corporation requested this tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA). DATES: This regulation is effective January 30, 2008. Objections and requests for hearings must be received on or before March 31, 2008, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION ). ADDRESSES: EPA has established a docket for this action under docket identification
(ID)number EPA-HQ-OPP-2006-0481. To access the electronic docket, go to *http://www.regulations.gov* , select “Advanced Search,” then “Docket Search.” Insert the docket ID number where indicated and select the “Submit” button. Follow the instructions on the regulations.gov website to view the docket index or access available documents. All documents in the docket are listed in the docket index available in regulations.gov. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information
(CBI)or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available in the electronic docket at *http://www.regulations.gov* , or, if only available in hard copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket Facility telephone number is
(703)305-5805. FOR FURTHER INFORMATION CONTACT: Janet Whitehurst, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:
(703)305-6129; e-mail address: *whitehurst.janet@epa.gov* . SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to those engaged in the following activities: • Crop production (NAICS code 111), e.g., agricultural workers; greenhouse, nursery, and floriculture workers; farmers. • Animal production (NAICS code 112), e.g., cattle ranchers and farmers, dairy cattle farmers, livestock farmers. • Food manufacturing (NAICS code 311), e.g., agricultural workers; farmers; greenhouse, nursery, and floriculture workers; ranchers; pesticide applicators. • Pesticide manufacturing (NAICS code 32532), e.g., agricultural workers; commercial applicators; farmers; greenhouse, nursery, and floriculture workers; residential users. This listing is not intended to be exhaustive, but rather to provide a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT . B. How Can I Access Electronic Copies of this Document? In addition to accessing an electronic copy of this **Federal Register** document through the electronic docket at *http://www.regulations.gov* , you may access this **Federal Register** document electronically through the EPA Internet under the “ **Federal Register** ” listings at *http://www.epa.gov/fedrgstr* . You may also access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Government Printing Office's pilot e-CFR site at *http://www.gpoaccess.gov/ecfr* . C. Can I File an Objection or Hearing Request? Under section 408(g) of FFDCA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2006-0481 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk as required by 40 CFR part 178 on or before March 31, 2008. In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing that does not contain any CBI for inclusion in the public docket that is described in ADDRESSES . Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit this copy, identified by docket ID number EPA-HQ-OPP-2006-0481, by one of the following methods: • *Federal eRulemaking Portal* : *http://www.regulations.gov* . Follow the on-line instructions for submitting comments. • *Mail* : Office of Pesticide Programs
(OPP)Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. • *Delivery* : OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only accepted during the Docket's normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket Facility telephone number is
(703)305-5805. II. Petition for Tolerance In the **Federal Register** of June 14, 2006 (71 FR 34345) (FRL-8071-4), 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 5F7016) by Valent U.S.A. Company, 1600 Riviera Ave., Walnut Creek, CA 94596-8025. The petition requested that 40 CFR 180.627 be amended by establishing a tolerance for residues of the fungicide fluopicolide, 2,6-dichloro- *N* -[[3-chloro-5-(trifluoromethyl)-2-pyridinyl]methyl]benzamide, in or on grape at 2.0 ppm; raisin at 6.0 ppm; vegetable, leafy (except brassica) (group 4) at 20.0 ppm; vegetable, fruiting (group 8) at 0.8 ppm; vegetable, cucurbit (group 9) at 0.4 ppm; potato at 0.02 ppm; sweet potato, roots at 0.02 ppm; wheat, forage at 0.2 ppm; wheat, grain at 0.02 ppm; and wheat, hay and straw at 0.5 ppm. That notice referenced a summary of the petition prepared by Valent U.S.A. Company, the registrant, which is available to the public in the docket, *http://www.regulations.gov* . Comments were received on the notice of filing. EPA's response to these comments is discussed in Unit IV.C. Based upon review of the data supporting the petition, EPA has modified the tolerances proposed for vegetable, leafy, except brassica, group 4; vegetable, fruiting, group 8; and vegetable, curcurbit, group 9. The appropriate tolerances for vegetable, leafy, except brassica, group 4; vegetable, fruiting, group 8; and vegetable, curcurbit, group 9 are 25, 1.6, and 0.50 ppm, respectively. These tolerances were determined considering residue/processing data and, as applicable, recent agency guidance (“NAFTA Guidance Document for Guidance for Setting Pesticide Tolerances Based on Field Trial Data,” Regulatory Proposal PRO2005-04, U.S EPA and Health Canada, Pest Management Regulatory Agency, 2005 ( *http://www.pmra-arla.gc.ca/english/pdf/pro/pro2005-04-e.pdf* ). For the reasons stated in Unit V., EPA is not establishing at this time the following petitioned-for tolerances: Potato; wheat, forage; wheat, grain; and wheat, hay and straw. The existing tolerances for imported grape at 2.0 ppm, and grape, raisin at 6.0 ppm now apply to all imported and U.S. domestic grapes. Additionally, the residue definition in paragraph
(a)of the tolerance expression is being changed from only fluopicolide, to: Tolerances are established for residues of fluopicolide, 2,6-dichloro- *N* -[[3-chloro-5-(trifluoromethyl)-2-pyridinyl]methyl]benzamide, as an indicator of combined residues of fluopicolide and its metabolite, 2,6-dichlorobenzamide (BAM). III. Aggregate Risk Assessment and Determination of Safety Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .” These provisions were added to FFDCA by the Food Quality Protection Act
(FQPA)of 1996. Consistent with FFDCA section 408(b)(2)(D), and the factors specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for the petitioned-for tolerance for residues of fluopicolide, 2,6-dichloro- *N* -[[3-chloro-5-(trifluoromethyl)-2-pyridinyl]methyl]benzamide, as an indicator of combined residues of fluopicolide and its metablite, BAM, on grape at 2.0 ppm; grape, raisin at 6.0 ppm; vegetable, cucurbit, group 9 at 0.50 ppm; vegetable, fruiting, group 8 at 1.6 ppm; vegetable, leafy, except brassica, group 4 at 25 ppm; and vegetable, tuberous and corm, subgroup, except potato 1D at 0.02 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 adverse effects caused by fluopicolide 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 in the document entitled *Fluopicolide: Human Health Risk Assessment for Proposed Uses on tuberous and corm vegetables, leafy vegetables (except brassica), fruiting vegetables, cucurbit vegetables, grapes, turf, and ornamentals, and for indirect or inadvertent residues on the rotational crop wheat* at regulations.gov. BAM (AE C653711) is a common metabolite and/or environmental degradate of fluopicolide as well as the herbicide dichlobenil. Because the toxicological endpoints of BAM and fluopicolide are different, a separate human health risk assessment was conducted for BAM residues. The BAM risk assessment considered residues resulting from both fluopicolide and dichlobenil uses. However, BAM residues generated from fluopicolide uses are expected to be significantly lower than BAM residues from dichlobenill uses. Specific information regarding the metabolite of fluopicolide can be found in the document entitled *2,6-Dichlorobenzamide
(BAM)as a Metabolite/Degradate of Fluopicolide and Dichlobenil. Human Health Risk Assessment for Proposed Uses of fluopicolide on tuberous and corm vegetables, leafy vegetables (except brassica), fruiting vegetables, cucurbit vegetables, grapes, turf, and ornamentals, and for indirect or inadvertent residues on the rotational crop wheat* (PC Codes: 027402 BAM and 027412 (fluopicolide), Petition No: 5F7016 at regulations.gov). Both referenced documents are available in the docket established for this action, which is described under ADDRESSES , and is identified as docket ID number EPA-HQ-OPP-2006-0481. B. Toxicological Endpoints For hazards that have a threshold below which there is no appreciable risk, the toxicological level of concern
(LOC)is derived from the highest dose at which NOAEL in the toxicology study identified as appropriate for use in risk assessment. However, if a NOAEL cannot be determined, the lowest dose at which adverse effects of concern are identified the LOAEL is sometimes used for risk assessment. Uncertainty (UFs)/safety factors are used in conjunction with the LOC to take into account uncertainties inherent in the extrapolation from laboratory animal data to humans and in the variations in sensitivity among members of the human population as well as other unknowns. Safety is assessed for acute and chronic risks by comparing aggregate exposure to the pesticide to the acute population adjusted dose
(aPAD)and chronic population adjusted dose (cPAD). The aPAD and cPAD are calculated by dividing the LOC by all applicable UFs. Short-term, intermediate-term, and long-term risks are evaluated by comparing aggregate exposure to the LOC to ensure that the margin of exposure
(MOE)called for by the product of all applicable UFs is not exceeded. A summary of the toxicological endpoints for fluopicolide used for human risk assessment can be found at regulations.gov in the document entitled *Fluopicolide: Human Health Risk Assessment for Proposed Uses on tuberous and corm vegetables, leafy vegetables (except brassica), fruiting vegetables, cucurbit vegetables, grapes, turf, and ornamentals, and for indirect or inadvertent residues on the rotational crop wheat* (PC Code: 027412, Petition No: 5F7016 (71 FR 34345) (FRL-8071-4) in docket ID number EPA-HQ-OPP-2006-0481). A summary of the toxicological endpoints for BAM used for human risk assessment can be found at regulations.gov in the document entitled *2,6-Dichlorobenzamide BAM as a Metabolite/Degradate of Fluopicolide and Dichlobenil. Human Health Risk Assessment for Proposed Uses of fluopicolide on tuberous and corm vegetables, leafy vegetables (except brassica), fruiting vegetables, cucurbit vegetables, grapes, turf, and ornamentals, and for indirect or inadvertent residues on the rotational crop wheat* (PC Codes: 027402 BAM and 027412 Fluopicolide, Petition No: 5F7016 (71 FR 34345) (FRL-8071-4) in docket ID number EPA-HQ-OPP-2006-0481). C. Exposure Assessment 1. *Dietary exposure from food and feed uses* . In evaluating dietary exposure to fluopicolide, EPA considered exposure under the petitioned-for tolerances as well as all existing fluopicolide tolerances in (40 CFR 180.627). EPA assessed dietary exposures from fluopicolide 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 fluopicolide; therefore, a quantitative acute dietary exposure assessment is unnecessary. A conservative acute dietary exposure assessment for the metabolite of fluopicolide, BAM, was conducted. Maximum residues of BAM from fluopicolide field trials on tuberous and corm vegetables, leafy vegetables (except brassica), fruiting vegetables, cucurbit vegetables, grapes (domestic and imported), (except potato), and from dichlobenil field trials on food commodities with established/pending tolerances (40 CFR 180.231) were included in the assessments. The assessments used 100% percent crop treated
(PCT)except for apples, blueberries, cherries, cranberries, peaches, pears, and raspberries. ii. *Chronic exposure* . In conducting the chronic dietary exposure assessments EPA used the food consumption data from the United States Department of Agriculture
(USDA)1994-1996 Continuing Surveys of Food Intakes by Individuals (CSFII). Two chronic assessments were conducted: One assessment for parent fluopicolide (including residues of concern other than the metabolite BAM) and one assessment for BAM. As to residue levels in food, EPA assumed for the parent fluopicolide assessment that all foods for which there are tolerances were treated and contain tolerance-level residues. A conservative chronic dietary exposure assessment for the metabolite of fluopicolide, BAM, was conducted as described in Unit III.C.1.i. for the acute assessment. iii. *Cancer* . Fluopicolide is not likely to be carcinogenic to humans; therefore, a cancer risk assessment was not conducted for parent fluopicolide. The carcinogenic potential of BAM has been evaluated in only one species, the rat. That study showed increased incidence of hepatocellular adenomas in high-dose females that was marginally statistically significant. To be conservative, EPA has assumed that BAM's potential for carcinogenicity is similar to the parent having the greatest carcinogenic potential. As noted, fluopicolide has been classified as not likely to be carcinogenic to humans; dichlobenil is classified as “Group C, possible human carcinogen” with the reference dose
(RfD)approach utilized for quantification of human risk. Accordingly, BAM's cancer risk is based on the chronic risk assessment and no separate cancer risk or exposure assessment has been conducted. iv. *Anticipated residue and PCT information* . Anticipated residues and PCT information were used for the acute and chronic dietary risk assessments for BAM. Maximum residues of BAM from fluopicolide field trials on tuberous and corm vegetables (except potato) leafy vegetables (except brassica), fruiting vegetables, cucurbit vegetables, grapes (domestic and imported), and from dichlobenil field trials on food commodities with established/pending tolerances (40 CFR 180.231) were included in the assessments. The assessments assumed 100% CT for fluopicolide and dichlobenil, except for the following dichlobenil-treated crops: a. For the acute assessment: Apples (2.5%), blueberries (2.5%), cherries (2.5%), peaches (2.5%), pears (2.5%), and raspberries (5%). b. For the chronic assessment: Apples (1%), blueberries (1%), cherries (1%), cranberries (45%), peaches (1%), pears (1%), and raspberries (5%). 2. *Dietary exposure from drinking water* . The Agency lacks sufficient monitoring data to complete a comprehensive dietary exposure analysis and risk assessment for fluopicolide in drinking water. Because the Agency does not have comprehensive monitoring data, drinking water concentration estimates are made by reliance on simulation or modeling taking into account data on the environmental fate characteristics of fluopicolide. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at *http://www.epa.gov/oppefed1/models/water/index.htm* . Based on the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI-GROW) models, the estimated environmental concentrations
(EECs)of fluopicolide for acute exposures are estimated to be 26.81 parts per billion
(ppb)for surface water and 0.64 ppb for ground water. The EECs for chronic (non cancer) exposures are estimated to be 8.34 ppb for surface water and 0.64 ppb for ground water. The EECs for chronic (cancer) exposures are estimated to be 6.14 ppb for surface water and 0.64 ppb for ground water. Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For chronic dietary risk assessment, the water concentration of value 8.34 ppb was used to access the contribution to drinking water. Considering residues of BAM in drinking water from uses of dichlobenil and fluopicolide, the uses on dichlobenil will result in the highest residues in drinking water. Therefore, the results from dichlobenil (from the use of nutsedge at 10 lb. dichlobenil active ingredient/Acre (ai)/(A)) are used in this assessment, i.e., 56.2 ppb was used as the value of BAM residues in drinking water in the dietary assessment for both the acute and chronic assessments. 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). Fluopicolide is proposed for registration on the following residential non-dietary sites: Residential turfgrass and ornamental plants. EPA assessed residential exposure using the following assumptions: Residential handlers may receive short-term dermal and inhalation exposure to fluopicolide when mixing, loading, and applying the formulations. Residential postapplication exposure via the dermal route is likely for adults and children entering treated lawns. Toddlers may also experience exposure via incidental non-dietary ingestion (i.e., hand-to-mouth, object-to-mouth (turfgrass), and soil ingestion) during postapplication activities on treated turf. While it is necessary to evaluate residential exposure from all sources of fluopicolide's metabolite BAM, the use pattern for dichlobenil is not expected to result in scenarios with significant residential/non-occupational exposure. Therefore, BAM exposure estimates are based on fluopicolide use only. Residential handler exposure was evaluated for parent fluopicolide only because the metabolite BAM is believed to form slowly in plants and soil after the product containing the parent (fluopicolide) has been applied. Residential postapplication exposure via the dermal route is likely for adults and children entering treated lawns. Toddlers may also experience exposure via incidental non-dietary ingestion (i.e., hand-to-mouth, object-to-mouth (turf grass), and soil ingestion) during postapplication activities on treated turf. Residential short-term/intermediate-term postapplication MOEs were estimated for “Day 0” exposure (i.e., the day of application). 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 fluopicolide and any other substances. For the purposes of this tolerance action, therefore, EPA has not assumed that fluopicolide 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 EPA's website at *http://www.epa.gov/pesticides/cumulative* . Fluopicolide and dichlobenil can form the common metabolite, BAM. To support existing tolerances and to establish new tolerances for fluopicolide, EPA conducted a human health risk assessment for exposure to BAM resulting from the use of all current and pending uses of fluopicolide and the herbicide dichlobenil. The risk assessment is conservative in terms of potential dietary and non-dietary exposures. In addition, the Agency retained the additional tenfold
(10X)FQPA safety factor
(SF)for the protection of infants and children. The assessment includes evaluations of risks for various subgroups, including those composed of infants and children. The Agency's complete risk assessment can be found at regulations.gov, docket ID number EPA-HQ-OPP-2006-0481. D. Safety Factor for Infants and Children 1. *In general* . Section 408 of FFDCA provides that EPA shall apply an additional 10X margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the FQPA SF. In applying this provision, EPA either retains the default value of 10X when reliable data do not support the choice of a different factor, or, if reliable data are available, EPA uses a different additional FQPA SF value based on the use of traditional UFs and/or special FQPA SFs, as appropriate. 2. *Prenatal and postnatal sensitivity* . Since there was evidence of increased susceptibility of offspring following exposure to fluopicolide in rat developmental study, a Degree of Concern Analysis was performed to: i. Determine the level of concern for the effects observed when considered in the context of all available toxicity data. ii. Identify any residual uncertainties after establishing toxicity endpoints and traditional UFs to be used in the risk assessment for this chemical. EPA concluded that there is low concern for the qualitative susceptibility because: The offspring toxicity was well characterized and was accompanied by maternal toxicity; there was a clear NOAEL/LOAEL for offspring toxicity; and because the dose/endpoint selected for long-term risk assessments is considerably lower and would address the concerns for offspring toxicity seen in this study. Therefore, there are no residual uncertainties for prenatal and/or postnatal toxicity. 3. *Conclusion* . As to fluopicolide, EPA has determined that reliable data show that it would be safe for infants and children to reduce the FQPA SF to 1X. That decision is based on the following findings: i. The toxicity database for fluopicolide is complete. ii. There is no indication that fluopicolide is a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity. iii. Although there is qualitative evidence of increased susceptibility in the prenatal developmental studies in rats, the risk assessment team did not identify any residual uncertainties after establishing toxicity endpoints and traditional UFs to be used in the risk assessment of fluopicolide. The degree of concern for prenatal and/or postnatal toxicity is low. iv. There are no residual uncertainties identified in the exposure data bases. The dietary food exposure assessments were performed based on 100% CT and tolerance-level residues. Conservative ground water and surface water modeling estimates were used. Similarly conservative Residential Standard Operating Procedues
(SOPs)were used to assess postapplication exposure to children as well as incidental oral exposure of toddlers. These assessments will not underestimate the exposure and risks posed by fluopicolide. EPA is retaining the 10X FQPA SF for BAM for those exposure scenarios that do not rely on dichlobenil toxicity data. These scenarios are acute dietary for the general population including infants and children, females 13-49 years of age, chronic dietary, and incidental oral non-dietary. This is due to the incompleteness of the data base with regard to the systemic neurotoxic potential of BAM, including olfactory toxicity via the oral route of exposure. For the dermal and inhalation routes of exposures, for which the Agency is relying on dichlobenil toxicity data. EPA has reduced the FQPA SF for BAM toxicity to 1X. The reasons for this are that, based on a comparison of toxicity via the intraperitoneal route of exposure, higher doses of BAM are needed to induce levels of olfactory toxicity that are similar to those caused by dichlobenil (Brandt et al. 1990; Brittebo et al. 1991; Eriksson and Brittebo 1995). Olfactory toxicity was the endpoint chosen for these exposure scenarios. E. Aggregate Risks and Determination of Safety Safety is assessed for acute and chronic risks by comparing aggregate exposure to the pesticide to the aPAD and cPAD. The aPAD and cPAD are calculated by dividing the LOC by all applicable UFs. For linear cancer risks, EPA calculates the probability of additional cancer cases given aggregate exposure. Short-term, intermediate-term, and long-term risks are evaluated by comparing aggregate exposure to the LOC to ensure that the MOE called for by the product of all applicable UFs is not exceeded. 1. *Acute risk* . EPA does not expect that fluopicolide will pose an acute risk because an endpoint attributable to a single dose was not identified from the available data for fluopicolide. The acute dietary exposure estimates for BAM at the 99.9 th percentile of the exposure distribution are 11% of the aPAD for the general U.S. population and 28% aPAD for all infants < 1 year old), the most highly exposed group. 2. *Chronic risk* . The chronic dietary exposure estimates for fluopicolide are 6% cPAD for the general U.S. population and 9% cPAD for children 1-2 years old, the most highly exposed subgroup. Based on the use pattern, chronic residential exposure to residues of fluopicolide is not expected. The chronic dietary exposure estimates for BAM are 29% of the chronic cPAD for the general U.S. population and 93% cPAD for all infants ( < year old), the most highly exposed group which is not of concern to the Agency. 3. *Short-term risk* . Short-term aggregate exposure takes into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Fluopicolide is proposed for registration for use(s) that could result in short-term residential exposure and the Agency has determined that it is appropriate to aggregate chronic food and water and short-term exposures for fluopicolide. Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded that food, water, and residential exposures result in aggregate MOEs greater than the LOC of 100 for all population groups, and the aggregate short-term risk estimates for fluopicolide are below the Agency's level of concern. Short-term exposures for fluopicolide's metabolite BAM, may occur as a result of activities on treated turf. Incidental oral exposures related to turf activities have been combined with chronic dietary exposure estimates to assess short-term aggregate exposure for BAM. Since aggregate MOEs for BAM are greater than the LOC, they represent risk estimates that are below the Agency's level of concern. 4. *Intermediate-term risk* . Intermediate-term aggregate exposure takes into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Fluopicolide is proposed for registration for use(s) that could result in intermediate-term residential exposure and the Agency has determined that it is appropriate to aggregate chronic food and water and intermediate-term exposures for fluopicolide. The intermediate-term aggregate risk for fluopicolide and BAM is the same as calculated above for the short-term aggregate risk. 5. *Long-term aggregate risk* . In examining long-term aggregate risk, the Agency has assumed that the only pathway of exposure relevant to that time frame is dietary exposure (i.e., any non-dietary exposures are short-term and/or intermediate-term in duration). Therefore, the long-term aggregate risk is composed of exposures to fluopicolide residues in food and drinking water and is equivalent to the chronic dietary risk. The chronic risk estimates are below the Agency's level of concern for all population subgroups. 6. *Aggregate cancer risk for U.S. population* . Fluopicolide has been classified as “not likely to be carcinogenic to humans” and, is thus not expected to pose a cancer risk. As explained in Unit III. the chronic risk assessment for BAM is protective of any potential cancer risk. 7. *Determination of safety* . Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, or to infants and children from aggregate exposure to fluopicolide residues. IV. Other Considerations A. Analytical Enforcement Methodology Adequate enforcement methodology, the Liquid Chromatography/Mass Spectrometry (LC/MS/MS) method 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 No Codex, Canadian, or Mexican maximum residue limits
(MRLs)or tolerances have been established for fluopicolide. C. Response to Comments One comment was received from B. Sachau. Ms. Sachau's comments regarding general exposure to pesticides 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 fluopicolide, including all anticipated dietary exposures and other exposures for which there is reliable information. This comment as well as her comments regarding animal testing have been responded to by the Agency on several occasions. For examples, see the **Federal Register** issues of January 7, 2005 (70 FR 1349) (FRL-7691-4) and October 29, 2004 (69 FR 63083) (FRL-7681-9). V. Conclusion Therefore, tolerances are established for residues of fluopicolide, 2,6-dichloro- *N* -[[3-chloro-5-(trifluoromethyl)-2-pyridinyl]methyl]benzamide, as an indicator of combined residues of fluopicolide and its metabolite, BAM, on grape at 2.0 ppm; grape, raisin at 6.0 ppm; vegetable, cucurbit, group 9 at 0.50 ppm; vegetable, fruiting, group 8 at 1.6 ppm; vegetable, leafy, except brassica, group 4 at 25 ppm; and vegetable, tuberous and corm, except potato, subgroup 1D at 0.02 ppm. Additional livestock feeding studies and livestock tolerance enforcement methods are needed to support tolerances for: Potatoes and wheat. Tolerances for these commodities are not established at this time. VI. Statutory and Executive Order Reviews This final rule establishes a tolerance under section 408(d) of FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget
(OMB)has exempted these types of actions from review under Executive Order 12866, entitled *Regulatory Planning and Review* (58 FR 51735, October 4, 1993). Because this rule has been exempted from review under Executive Order 12866, this rule is not subject to Executive Order 13211, *Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use* (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled *Protection of Children from Environmental Health Risks and Safety Risks* (62 FR 19885, April 23, 1997). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 *et seq* ., nor does it require any special considerations under Executive Order 12898, entitled *Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations* (59 FR 7629, February 16, 1994). Since tolerances and exemptions that are established on the basis of a petition under section 408(d) of FFDCA, such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act
(RFA)(5 U.S.C. 601 *et seq* .) do not apply. This final rule directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled *Federalism* (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled *Consultation and Coordination with Indian Tribal Governments* (65 FR 67249, November 6, 2000) do not apply to this rule. In addition, This rule does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995
(UMRA)(Public Law 104-4). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). VII. Congressional Review Act The Congressional Review Act, 5 U.S.C. 801 *et seq* ., generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of this final rule in the **Federal Register** . This final rule is not a “major rule” as defined by 5 U.S.C. 804(2). List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: January 17, 2008. Debra Edwards, 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 180.627 is amended by revising paragraph
(a)to read as follows: 180.627 Fluopicolide; tolerances for residues.
(a)*General* . Tolerances are established for residues of fluopicolide, 2,6-dichloro- *N* -[[3-chloro-5-(trifluoromethyl)-2-pyridinyl]methyl]benzamide, as an indicator of combined residues of fluopicolide and its metabolite, 2,6-dichlorobenzamide (BAM). Commodity Parts per million Grape 2.0 Grape, raisin 6.0 Vegetable, cucurbit, group 9 0.50 Vegetable, fruiting, group 8 1.60 Vegetable, leafy, except brassica, group 4 25 Vegetable, tuberous and corm (except potato), subgroup 1D 0.02 [FR Doc. E8-1525 Filed 1-29-08; 8:45 am] BILLING CODE 6560-50-S DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency 44 CFR Part 67 Final Flood Elevation Determinations AGENCY: Federal Emergency Management Agency, DHS. ACTION: Final rule. SUMMARY: Base (1% annual chance) Flood Elevations
(BFEs)and modified BFEs are made final for the communities listed below. The BFEs and modified BFEs are the basis for the floodplain management measures that each community is required either to adopt or to show evidence of being already in effect in order to qualify or remain qualified for participation in the National Flood Insurance Program (NFIP). DATES: The date of issuance of the Flood Insurance Rate Map
(FIRM)showing BFEs and modified BFEs for each community. This date may be obtained by contacting the office where the maps are available for inspection as indicated on the table below. ADDRESSES: The final BFEs for each community are available for inspection at the office of the Chief Executive Officer of each community. The respective addresses are listed in the table below. FOR FURTHER INFORMATION CONTACT: William R. Blanton, Jr., Engineering Management Branch, Mitigation Directorate, Federal Emergency Management Agency, 500 C Street, SW., Washington, DC 20472,
(202)646-3151. SUPPLEMENTARY INFORMATION: The Federal Emergency Management Agency
(FEMA)makes the final determinations listed below for the modified BFEs for each community listed. These modified elevations have been published in newspapers of local circulation and ninety
(90)days have elapsed since that publication. The Mitigation Division Director of FEMA has resolved any appeals resulting from this notification. This final rule is issued in accordance with section 110 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4104, and 44 CFR part 67. FEMA has developed criteria for floodplain management in floodprone areas in accordance with 44 CFR part 60. Interested lessees and owners of real property are encouraged to review the proof Flood Insurance Study and FIRM available at the address cited below for each community. The BFEs and modified BFEs are made final in the communities listed below. Elevations at selected locations in each community are shown. *National Environmental Policy Act.* This final rule is categorically excluded from the requirements of 44 CFR part 10, Environmental Consideration. An environmental impact assessment has not been prepared. *Regulatory Flexibility Act.* As flood elevation determinations are not within the scope of the Regulatory Flexibility Act, 5 U.S.C. 601-612, a regulatory flexibility analysis is not required. *Regulatory Classification.* This final rule is not a significant regulatory action under the criteria of section 3(f) of Executive Order 12866 of September 30, 1993, Regulatory Planning and Review, 58 FR 51735. *Executive Order 13132, Federalism.* This final rule involves no policies that have federalism implications under Executive Order 13132. *Executive Order 12988, Civil Justice Reform.* This final rule meets the applicable standards of Executive Order 12988. List of Subjects in 44 CFR Part 67 Administrative practice and procedure, Flood insurance, Reporting and recordkeeping requirements. Accordingly, 44 CFR part 67 is amended as follows: PART 67—[AMENDED] 1. The authority citation for part 67 continues to read as follows: Authority: 42 U.S.C. 4001 *et seq.* ; Reorganization Plan No. 3 of 1978, 3 CFR, 1978 Comp., p. 329; E.O. 12127, 44 FR 19367, 3 CFR, 1979 Comp., p. 376. § 67.11 [Amended] 2. The tables published under the authority of § 67.11 are amended as follows: Flooding source(s) Location of referenced elevation * Elevation in feet
(NGVD)+ Elevation in feet
(NAVD)# Depth in feet above ground. Modified Communities affected Baker County, Florida, and Incorporated Areas Docket No.: FEMA-B-7724 Barber Bay Tributary At Confluence with South Prong Saint Mary's River +85 City of Macclenny. 1,100 feet upstream of County Road 228 +124 3,000 feet upstream of County Road 228 +128 South Prong Saint Mary's River 6,459 feet downstream from the confluence with Barber Bay Tributary +79 Baker County (Unincorporated Areas). 8,800 feet upstream from the confluence with South Prong St. Mary's River Tributary 8 +100 South Prong Saint Mary's River Tributary 8 At confluence with South Prong Saint Mary's River +97 Baker County (Unincorporated Areas). 12,660 feet upstream from the confluence with South Prong St. Mary's River +122 Turkey Creek 1,680 feet upstream of the confluence with Turkey Creek Tributary 2 +111 Baker County (Unincorporated Areas). 1,250 feet upstream of Barber Road +116 810 feet downstream of Barber Road +117 Turkey Creek Tributary 1 At confluence with Turkey Creek +95 Baker County (Unincorporated Areas). 8,960 feet upstream of State Highway 121 +138 Turkey Creek Tributary 1.1 At confluence with Turkey Creek Tributary 1.1 +98 Baker County (Unincorporated Areas). 1,190 feet upstream of Woodlawn Road +117 1,280 feet upstream of Woodlawn Road +118 1,940 feet upstream of Woodlawn Road +119 Turkey Creek Tributary 2 At Confluence with Turkey Creek +109 City of Macclenny. 3,080 feet upstream of the confluence with Turkey Creek Tributary 2.1 +125 145 feet upstream of U.S. Highway 90 +129 At Interstate 10 +129 Turkey Creek Tributary 2.1 At confluence with Turkey Creek Tribuatry 2 +115 City of Macclenny. At Powerline Road +122 3,040 feet upstream of Canal Road +132 * National Geodetic Vertical Datum. + North American Vertical Datum. # Depth in feet above ground. ADDRESSES City of Macclenny Maps are available for inspection at 32 South 5th Street, Macclenny, FL 32063. Baker County (Unincorporated Areas) Maps are available for inspection at 55 North 3rd Street, Macclenny, FL 32063. Northumberland County, Pennsylvania, and Incorporated Areas Docket No.: FEMA-B-7701 Boile Run Approximately 905 feet downstream of State Road 147 +432 Township of Lower Augusta. Approximately 690 feet upstream of State Road 147 +432 Dalmatia Creek Approximately at 90 feet downstream of State Road 147 +416 Township of Lower Mahanoy. Approximately at 900 feet upstream of State Road 147 +416 Limestone Run Approximately at 1,110 feet downstream of Filbert Street +468 Borough of Milton, Township of Turbot. Approximately at 1,600 feet upstream of Township Route 594 +519 Mahanoy Creek Approximately 2,120 feet downstream of State Road 147 +427 Township of Jackson. Approximately 2,900 feet upstream of State Road 147 +427 Mahantango Creek Approximately 1,000 feet downstream of State Road 147 +400 Township of Lower Mahanoy. Approximately at 3,000 feet upstream of State Road 147 +404 Muddy Run Approximately at 3,120 feet downstream of Legislative Route 49102 +472 Township of Turbot. Approximately at 50 feet downstream of Township Route 572 +472 Shamokin Creek Approximately 2,500 feet downstream of State Road 61 +583 Township of Ralpho, Township of Shamokin. Approximately 2,250 feet upstream of Irish Valley Road +617 Susquehanna River Approximately 18.6 miles downstream of Route 61, at Northumberland/Dauphin County line +400 Borough of Herndon, Borough of Northumberland, Borough of Riverside, City of Sunbury, Township of Lower Augusta, Township of Lower Mahanoy, Township of Point, Township of Rush, Township of Upper Augusta. Approximately 3.9 miles upstream of Route 54, at Northumberland/Montour County line +468 Tributary No. 1 to Limestone Run Approximately 2,055 feet downstream of State Road 254 +476 Township of Turbot. Approximately 250 feet downstream of State Road 254 +476 * National Geodetic Vertical Datum. + North American Vertical Datum. # Depth in feet above ground. ADDRESSES Borough of Herndon Maps are available for inspection at Herndon Borough Municipal Building, P.O. Box 385, Herndon, PA 17830. Borough of Milton Maps are available for inspection at Milton Borough Office, 2nd Filbert Street, Milton, Milton, PA 17847. Borough of Northumberland Maps are available for inspection at Northumberland Borough Building, 221 Second Street, Northumberland, PA 17857. Borough of Riverside Maps are available for inspection at Riverside Borough Building, 301 Dewart Street, Riverside, PA 17868. City of Sunbury Maps are available for inspection at Sunbury City Code Administration Office, 225 Market Street, Sunbury, PA 17801. Township of Jackson Maps are available for inspection at Jackson Township Municipal Building, RR 2 Box 605, Herndon, PA 17830. Township of Lower Augusta Maps are available for inspection at Lower Augusta Township Building, Rd #3, Box 28, Sunbury, PA 17801. Township of Lower Mahanoy Maps are available for inspection at Lower Mahanoy Township Hall, Rd 1, Box 38, Dalmatia, PA 17017. Township of Point Maps are available for inspection at Point Township Municipal Building, 759 Ridge Road, Northumberland, PA 17857. (Catalog of Federal Domestic Assistance No. 97.022, “Flood Insurance.”) Dated: January 22, 2008. David I. Maurstad, Federal Insurance Administrator of the National Flood Insurance Program, Department of Homeland Security, Federal Emergency Management Agency. [FR Doc. E8-1651 Filed 1-29-08; 8:45 am] BILLING CODE 9110-12-P LEGAL SERVICES CORPORATION 45 CFR Part 1611 Income Level for Individuals Eligible for Assistance AGENCY: Legal Services Corporation. ACTION: Final rule. SUMMARY: The Legal Services Corporation (“Corporation”) is required by law to establish maximum income levels for individuals eligible for legal assistance. This document updates the specified income levels to reflect the annual amendments to the Federal Poverty Guidelines as issued by the Department of Health and Human Services. DATES: *Effective Date:* This rule is effective as of January 30, 2008. FOR FURTHER INFORMATION CONTACT: Mattie Cohan, Senior Assistant General Counsel, Legal Services Corporation, 3333 K St., NW., Washington, DC 20007;
(202)295-1624; *mcohan@lsc.gov* . SUPPLEMENTARY INFORMATION: Section 1007(a)(2) of the Legal Services Corporation Act (“Act”), 42 U.S.C. 2996f(a)(2), requires the Corporation to establish maximum income levels for individuals eligible for legal assistance, and the Act provides that other specified factors shall be taken into account along with income. Section 1611.3(c) of the Corporation's regulations establishes a maximum income level equivalent to one hundred and twenty-five percent (125%) of the Federal Poverty Guidelines. Since 1982, the Department of Health and Human Services has been responsible for updating and issuing the Federal Poverty Guidelines. The revised figures for 2008 set out below are equivalent to 125% of the current Federal Poverty Guidelines as published on January 23, 2008 (73 FR 3971). In addition, LSC is publishing charts listing income levels that are 200% of the Federal Poverty Guidelines. These charts are for reference purposes only as an aid to grant recipients in assessing the financial eligibility of an applicant whose income is greater than 200% of the applicable Federal Poverty Guidelines amount, but less than 200% of the applicable Federal Poverty Guidelines amount (and who may be found to be financially eligible under duly adopted exceptions to the annual income ceiling in accordance with sections 1611.3, 1611.4 and 1611.5). List of Subjects in 45 CFR Part 1611 Grant programs—law, Legal services. For reasons set forth above, 45 CFR part 1611 is amended as follows: PART 1611—ELIGIBILITY 1. The authority citation for part 1611 continues to read as follows: Authority: Secs. 1006(b)(1), 1007(a)(1) Legal Services Corporation Act of 1974, 42 U.S.C. 2996e(b)(1), 2996f(a)(1), 2996f(a)(2). 2. Appendix A of part 1611 is revised to read as follows: Appendix A of Part 1611.—Legal Services Corporation 2008 Poverty Guidelines* Size of household 48 contiguous states and the District of Columbia Alaska Hawaii 1 $13,000 $16,250 $14,950 2 17,500 21,875 20,125 3 22,000 27,500 25,300 4 26,500 33,125 30,475 5 31,000 38,750 35,650 6 35,500 44,375 40,825 7 40,000 50,000 46,000 8 44,500 55,625 51,175 For each additional member of the household in excess of 8, add 4,500 5,625 5,175 * The figures in this table represent 125% of the poverty guidelines by household size as determined by the Department of Health and Human Services. Reference Chart.—200% of DHHS Federal Poverty Guidelines Size of household 48 contiguous states and the District of Columbia Alaska Hawaii 1 $20,800 $26,000 $23,920 2 28,000 35,000 32,200 3 35,200 44,000 40,480 4 42,400 53,000 48,760 5 49,600 62,000 57,040 6 56,800 71,000 65,320 7 64,000 80,000 73,600 8 71,200 89,000 81,880 For each additional member of the household in excess of 8, add: 7,200 9,000 8,280 Victor M. Fortuno, Vice President for Legal Affairs, General Counsel & Corporate Secretary. [FR Doc. E8-1574 Filed 1-29-08; 8:45 am] BILLING CODE 7050-01-P 73 20 Wednesday, January 30, 2008 Proposed Rules DEPARTMENT OF HOMELAND SECURITY 6 CFR Part 5 [Docket No. DHS-2007-0023] Privacy Act of 1974: Implementation of Exemptions AGENCY: Department of Homeland Security. ACTION: Notice of proposed rule making. SUMMARY: The Department of Homeland Security
(DHS)is giving concurrent notice of a revised and updated system of records pursuant to the Privacy Act of 1974 for the Immigration and Customs Enforcement
(ICE)Pattern Analysis and Information Collection (ICEPIC) system and this proposed rulemaking. In this proposed rulemaking, the Department proposes to exempt portions of the system of records from one or more provisions of the Privacy Act because of criminal, civil, and administrative enforcement requirements. DATES: Comments must be received on or before March 10, 2008. ADDRESSES: You may submit comments, identified by docket number DHS-2007-0023, by one of the following methods: • *Federal e-Rulemaking Portal: http://www.regulations.gov* . Follow the instructions for submitting comments. • *Fax:* 1-866-466-5370. • *Mail:* Hugo Teufel, III, Chief Privacy Officer, Department of Homeland Security, Washington, DC 20528. *Instructions:* All submissions received must include the agency name and docket number for this notice. All comments received will be posted without change to *http://www.regulations.gov* , including any personal information provided. *Docket:* For access to the docket to read background documents or comments received, go to *http://www.regulations.gov* . FOR FURTHER INFORMATION CONTACT: For system related questions please contact: Steven W. Cooper (202-616-7571), Executive Information Unit, Office of Investigations, U.S. Immigration and Customs Enforcement, 425 I Street, NW., Washington, DC 20536. For privacy issues, please contact: Hugo Teufel III (571-227-3813), Chief Privacy Officer, Privacy Office, U.S. Department of Homeland Security, Washington, DC 20528. SUPPLEMENTARY INFORMATION: *Background:* The Immigration and Customs Enforcement
(ICE)Pattern Analysis and Information Collection (ICEPIC) system allows ICE law enforcement agents and analysts to look for non-obvious relationship patterns among individuals and organizations that are indicative of violations of the customs and immigration laws that are enforced by DHS agencies, as well as possible terrorist threats and plots. From these relationships, ICE agents develop specific leads and intelligence for active and new investigations. Identified relationships will also be recorded for reuse in subsequent investigative analyses. The information processed by ICEPIC comes from existing ICE investigative and apprehension records systems, as well as immigration and alien admission records systems. ICEPIC includes capabilities that assist investigators to record results of analyses performed in support of investigations and to capture additional relevant information obtained from outside sources. The information collected by, on behalf of, in support of, or in cooperation with DHS and its components may contain personally identifiable information collected by other Federal, State, local, tribal, foreign, or international government agencies. In this notice of proposed rulemaking, DHS now is proposing to exempt ICEPIC, in part, from certain provisions of the Privacy Act. The Privacy Act embodies fair information principles in a statutory framework governing the means by which the United States Government collects, maintains, uses, and disseminates personally identifiable information. The Privacy Act applies to information that is maintained in a “system of records.” A “system of records” is a group of any records under the control of an agency from which information is retrieved by the name of the individual or by some identifying number, symbol, or other identifying particular assigned to the individual. Individuals may request their own records that are maintained in a system of records in the possession or under the control of DHS by complying with DHS Privacy Act regulations, 6 CFR part 5. The Privacy Act requires each agency to publish in the **Federal Register** a description of the type and character of each system of records that the agency maintains, and the routine uses that are contained in each system in order to make agency recordkeeping practices transparent, to notify individuals regarding the uses to which personally identifiable information is put, and to assist individuals in finding such files within the agency. The Privacy Act allows Government agencies to exempt certain records from the access and amendment provisions. If an agency claims an exemption, however, it must issue a Notice of Proposed Rulemaking to make clear to the public the reasons why a particular exemption is claimed. DHS is claiming exemptions from certain requirements of the Privacy Act for ICEPIC. Some information in ICEPIC relates to official DHS national security, law enforcement, immigration, and intelligence activities. These exemptions are needed to protect information relating to DHS activities from disclosure to subjects or others related to these activities. Specifically, the exemptions are required to preclude subjects of these activities from frustrating these processes; to avoid disclosure of activity techniques; to protect the identities and physical safety of confidential informants and of immigration and border management and law enforcement personnel; to ensure DHS' ability to obtain information from third parties and other sources; to protect the privacy of third parties; and to safeguard classified information. Disclosure of information to the subject of the inquiry could also permit the subject to avoid detection or apprehension. The exemptions proposed here are standard law enforcement and national security exemptions exercised by a large number of Federal law enforcement and intelligence agencies. In appropriate circumstances, where compliance would not appear to interfere with or adversely affect the law enforcement purposes of this system and the overall law enforcement process, the applicable exemptions may be waived on a case by case basis. A notice of system of records for the Department's ICE Pattern Analysis and Information Collection (ICEPIC) System is also published in this issue of the **Federal Register** . List of Subjects in 6 CFR Part 5 Freedom of information, Privacy. For the reasons stated in the preamble, DHS proposes to amend Chapter I of Title 6, Code of Federal Regulations, as follows: PART 5—DISCLOSURE OF RECORDS AND INFORMATION 1. The authority citation for part 5 continues to read as follows: Authority: Pub. L. 107-296, 116 Stat. 2135, 6 U.S.C. 101 et seq.; 5 U.S.C. 301. Subpart A also issued under 5 U.S.C. 552. Subpart B also issued under 5 U.S.C. 552a. 2. Add at the end of Appendix C to part 5 a new paragraph 6 to read as follows: Appendix C to Part 5—DHS Systems of Records Exempt From the Privacy Act 6. The Immigration and Customs Enforcement
(ICE)Pattern Analysis and Information Collection (ICEPIC) System consists of electronic and paper records and will be used by DHS and its components. ICEPIC is a repository of information held by DHS in connection with its several and varied missions and functions, including, but not limited to: the enforcement of civil and criminal laws (including the immigration law); investigations, inquiries, and proceedings there under; and national security and intelligence activities. ICEPIC contains information that is collected by, on behalf of, in support of, or in cooperation with DHS and its components and may contain personally identifiable information collected by other Federal, State, local, tribal, foreign, or international government agencies. Pursuant to exemption 5 U.S.C. 552a(j)(2) of the Privacy Act, portions of this system are exempt from 5 U.S.C. 552a(c)(3) and (4); (d); (e)(1), (e)(2), (e)(3), (e)(4)(G), (e)(4)(H), (e)(5) and (e)(8); (f), and (g). Pursuant to 5 U.S.C. 552a(k)(2), this system is exempt from the following provisions of the Privacy Act, subject to the limitations set forth in those subsections: 5 U.S.C. 552a (c)(3), (d), (e)(1), (e)(4)(G), (e)(4)(H), and (f). Exemptions from these particular subsections are justified, on a case-by-case basis to be determined at the time a request is made, for the following reasons:
(a)From subsection (c)(3) and
(4)(Accounting for Disclosures) because release of the accounting of disclosures could alert the subject of an investigation of an actual or potential criminal, civil, or regulatory violation to the existence of the investigation, and reveal investigative interest on the part of DHS as well as the recipient agency. Disclosure of the accounting would therefore present a serious impediment to law enforcement efforts and/or efforts to preserve national security. Disclosure of the accounting would also permit the individual who is the subject of a record to impede the investigation, to tamper with witnesses or evidence, and to avoid detection or apprehension, which would undermine the entire investigative process.
(b)From subsection
(d)(Access to Records) because access to the records contained in this system of records could inform the subject of an investigation of an actual or potential criminal, civil, or regulatory violation, to the existence of the investigation, and reveal investigative interest on the part of DHS or another agency. Access to the records could permit the individual who is the subject of a record to impede the investigation, to tamper with witnesses or evidence, and to avoid detection or apprehension. Amendment of the records could interfere with ongoing investigations and law enforcement activities and would impose an impossible administrative burden by requiring investigations to be continuously reinvestigated. In addition, permitting access and amendment to such information could disclose security-sensitive information that could be detrimental to homeland security.
(c)From subsection (e)(1) (Relevancy and Necessity of Information) because in the course of investigations into potential violations of Federal law, the accuracy of information obtained or introduced occasionally may be unclear or the information may not be strictly relevant or necessary to a specific investigation. In the interests of effective law enforcement, it is appropriate to retain all information that may aid in establishing patterns of unlawful activity.
(d)From subsection (e)(2) (Collection of Information from Individuals) because requiring that information be collected from the subject of an investigation would alert the subject to the nature or existence of an investigation, thereby interfering with the related investigation and law enforcement activities.
(e)From subsection (e)(3) (Notice to Subjects) because providing such detailed information would impede law enforcement in that it could compromise investigations by: revealing the existence of an otherwise confidential investigation and thereby provide an opportunity for the subject of an investigation to conceal evidence, alter patterns of behavior, or take other actions that could thwart investigative efforts; reveal the identity of witnesses in investigations, thereby providing an opportunity for the subjects of the investigations or others to harass, intimidate, or otherwise interfere with the collection of evidence or other information from such witnesses; or reveal the identity of confidential informants, which would negatively affect the informant's usefulness in any ongoing or future investigations and discourage members of the public from cooperating as confidential informants in any future investigations.
(f)From subsections (e)(4)(G) and
(H)(Agency Requirements), and
(f)(Agency Rules) because portions of this system are exempt from the individual access provisions of subsection
(d)for the reasons noted above, and therefore DHS is not required to establish requirements, rules, or procedures with respect to such access. Providing notice to individuals with respect to existence of records pertaining to them in the system of records or otherwise setting up procedures pursuant to which individuals may access and view records pertaining to themselves in the system would undermine investigative efforts and reveal the identities of witnesses, and potential witnesses, and confidential informants.
(g)From subsection (e)(5) (Collection of Information) because in the collection of information for law enforcement purposes it is impossible to determine in advance what information is accurate, relevant, timely, and complete. Compliance with (e)(5) would preclude DHS agents from using their investigative training and exercise of good judgment to both conduct and report on investigations.
(h)From subsection (e)(8) (Notice on Individuals) because compliance would interfere with DHS' ability to obtain, serve, and issue subpoenas, warrants, and other law enforcement mechanisms that may be filed under seal, and could result in disclosure of investigative techniques, procedures, and evidence.
(i)From subsection
(g)to the extent that the system is exempt from other specific subsections of the Privacy Act relating to individuals' rights to access and amend their records contained in the system. Therefore DHS is not required to establish rules or procedures pursuant to which individuals may seek a civil remedy for the agency's: Refusal to amend a record; refusal to comply with a request for access to records; failure to maintain accurate, relevant timely and complete records; or failure to otherwise comply with an individual's right to access or amend records. Hugo Teufel III, Chief Privacy Officer, Department of Homeland Security. [FR Doc. E8-1554 Filed 1-29-08; 8:45 am] BILLING CODE 4410-10-P NATIONAL CREDIT UNION ADMINISTRATION 12 CFR Parts 708a and 708b RIN 3133-AD40 Mergers, Conversion From Credit Union Charter, and Account Insurance Termination AGENCY: National Credit Union Administration (NCUA). ACTION: Advance notice of proposed rulemaking and request for comment (ANPR). SUMMARY: NCUA is considering whether to issue regulations to govern merger of a federally insured credit union
(FICU)into or a FICU's conversion to a financial institution other than a mutual savings bank (MSB). NCUA currently does not have regulations governing these transactions. Also, NCUA is considering amending its regulations regarding mergers, charter conversions, and changes in account insurance to address various issues these transactions present that affect member rights and ownership interests. These issues include accuracy of communications to members, voting integrity, fiduciary duty obligations for insiders, and member interest in credit union equity, for example, through merger dividends. NCUA seeks comment on the necessity of amending its current regulations to address these issues, any additional issues relevant to these transactions not noted in this ANPR, and, if commenters believe regulatory amendments are needed, suggestions on how to address these issues. DATES: Comments must be received on or before March 31, 2008. ADDRESSES: You may submit comments by any of the following methods (Please send comments by one method only): • *Federal eRulemaking Portal: http://www.regulations.gov* . Follow the instructions for submitting comments. • *NCUA Web Site: http://www.ncua.gov/RegulationsOpinionsLaws/proposed_regs/proposed_regs.html* . Follow the instructions for submitting comments. • *E-mail:* Address to *regcomments@ncua.gov* . Include “[Your name]—Comments on Advanced Notice of Proposed Rulemaking for Parts 708a and 708b” in the e-mail subject line. • *Fax:*
(703)518-6319. Use the subject line described above for e-mail. • *Mail:* Address to Mary Rupp, Secretary of the Board, National Credit Union Administration, 1775 Duke Street, Alexandria, Virginia 22314-3428. • *Hand Delivery/Courier:* Same as mail address. FOR FURTHER INFORMATION CONTACT: Frank Kressman, Staff Attorney, Office of General Counsel, at the above address or telephone:
(703)518-6540. SUPPLEMENTARY INFORMATION: A. Background The primary focus of this ANPR is protection of member interests in transactions where members have a great deal at stake because the transactions involve fundamental changes in their ownership or the structure of their credit union, including, in some cases, termination of a credit union charter or termination of federal account insurance. This ANPR concerns six types of transactions: Merger of a FICU into a FICU; merger of a FICU into a privately insured credit union (PICU); conversion of a federally-insured state credit union (FISCU) into a PICU; conversion of a FICU to an MSB; merger of a FICU into a financial institution other than an MSB; and conversion of a FICU into a financial institution other than an MSB. While these transactions are legally permissible, member ownership can be extinguished or diluted and members may have lesser voting rights or be deprived of the security of federal share insurance. These transactions raise various issues, as discussed below, that NCUA believes its current regulations may not adequately address. NCUA is considering amendments to make certain member interests are adequately protected, including helping members understand the risks and rewards associated with these transactions. In addition, NCUA has not promulgated rules on the merger of a FICU or conversion of a FICU into a financial institution other than an MSB and NCUA is considering the necessity of issuing rules to govern these transactions. As in all rulemaking it undertakes, NCUA's focus is on providing flexibility and fairness, imposing minimal regulatory burden on credit unions whose members choose to pursue any of these transactions, and protecting the National Credit Union Share Insurance Fund (NCUSIF). NCUA's legal authority to regulate these transactions derives from the Federal Credit Union Act (Act). The Act specifically authorizes the NCUA Board to prescribe rules governing mergers of FICUs, including mergers or consolidations with any noninsured credit union or institution. 12 U.S.C. 1766(a), 1785(b), 1785(c), and 1789(a). By definition, “noninsured” means not insured by the NCUSIF, 12 U.S.C. 1752(7), and, therefore, NCUA may prescribe rules governing mergers, conversions, or consolidations with PICUs or other financial institutions, for example, banks or thrifts insured by the Federal Deposit Insurance Corporation. Part 708b of NCUA's regulations, which is limited to “credit union into credit union” mergers, generally requires:
(1)Approval of a merger plan by the boards of directors of each credit union;
(2)submission of a written plan and other documents to NCUA; and
(3)approval of a plan or proposal by NCUA and, for federal credit unions, by members. 12 CFR Part 708b. If a federal credit union is in danger of insolvency, member approval is not required. 12 CFR 708b.105(b). NCUA considers various factors in approving or disapproving a merger including protecting member interests and effects on the NCUSIF. Similar to FICU to FICU mergers, NCUA broadly regulates the procedures and substance of FICU to PICU mergers including:
(1)Approval of a merger plan by the boards of directors of each credit union;
(2)submission of a written plan and other documents to NCUA; and
(3)approval of plan or proposal by NCUA and, for federal credit unions, by members. NCUA imposes additional notice, voting, and approval requirements on this type of transaction, including the use of form documents. 12 CFR Part 708b, Subpart B-Voluntary Termination or Conversion of Insured Status, and Subpart C-Forms. These requirements apply as well where a FISCU converts to a PICU. The Act specifically addresses FICU to MSB conversions. 12 U.S.C. 1785(b)(2). While a FICU may convert to an MSB without the prior approval of the NCUA Board, 12 U.S.C. 1785(b)(2)(A), it must provide notice to each of its members who is eligible to vote on the matter of its intent to convert 90, 60, and 30 days before the date of the member vote on the conversion. 12 U.S.C. 1785(b)(2)(C). In this context, the Act requires NCUA's regulations to be consistent with rules promulgated by other federal financial regulators and must be no more or less restrictive than those applicable to charter conversions by other financial institutions. 12 U.S.C. 1785(b)(2)(G)(i). NCUA administers the member vote, which is verified by the federal or state regulatory agency that would have jurisdiction over the institution after the conversion. If either NCUA or that regulatory agency disapproves of the methods by which the member vote was taken or procedures applicable to the member vote, the member vote shall be taken again, as directed by NCUA or the other agency. 12 U.S.C. 1785 (b)(2)(G)(ii). Additionally, the Act specifically provides that no director or senior management official may receive any economic benefit in connection with a conversion of the credit union other than director fees and other compensation and benefits paid in the ordinary course of business. 12 U.S.C. 1785(b)(2)(F). NCUA has implemented its statutory authority to administer FICU to MSB conversions. 12 CFR Part 708a. While the decision to convert belongs to members, to make this decision, members must be fully informed as to the reasons for the conversion and be able to consider the advantages and disadvantages. In 2006, NCUA revised Part 708a to improve the information available to members and the board of directors as they consider a possible conversion. 71 FR 77150 (December 22, 2006). The revisions included amended disclosures, revised voting procedures, procedures to facilitate communications among members, and procedures for members to provide their comments to directors before the credit union board votes on a conversion plan. NCUA has not issued regulations regarding the merger or conversion of a FICU into a financial institution other than an MSB. The NCUA Board has statutory authority to approve or disapprove these two kinds of transactions and authority to promulgate rules to regulate the substance and procedures of them. 12 U.S.C. 1766(a), 1785(b)(1)(A), 1785(b)(1)(D), 1789(a)(11). In approving or disapproving these transactions, the NCUA Board must consider a number of criteria including:
(1)The history, financial condition, and management policies of the credit union;
(2)the adequacy of the credit union's reserves;
(3)the economic advisability of the transaction;
(4)the general character and fitness of the credit union's management;
(5)the convenience and needs of the members to be served by the credit union; and
(6)whether the credit union is a cooperative association organized for the purpose of promoting thrift among its members and creating a source of credit for provident or productive purposes. 12 U.S.C. 1785(c). NCUA has not issued regulations regarding these transactions because there have been only a handful of these transactions; in those instances, credit unions sought Board approval by petition, fashioning a submission and following procedures generally in line with the requirements of Part 708a. B. Discussion 1. Credit Union Merger or Conversion Into a Financial Institution Other Than an MSB NCUA seeks comment on whether issuing rules to govern credit union mergers or conversions into a financial institution other than an MSB would be beneficial for credit union members. NCUA is considering establishing an administrative framework and procedures rather than the case-by-case approach that has been used. Potential downsides to issuing a rule are that, having a rule in place, might encourage these transactions and many observers believe they are, only in unusual circumstances, in the best interests of members. Nevertheless, having a rule in place, with appropriate safeguards for member interests, could assist all parties, including the NCUA Board, in protecting protect member interests in their credit unions. If it is determined a new rule would be beneficial, NCUA believes the rule, in brief, would establish a comprehensive administrative framework to process these transactions, while including provisions to ensure the protection of member rights and interests. In addition, NCUA would consider clarifying in a rule the criteria it would apply in approving these transactions. Procedurally, a new rule could be modeled after part 708b, including the use of form documentation and, in addition to borrowing the certain provisions of part 708b, it could address the issues discussed below that the Board believes would also be present in these transactions. Some observers have argued that direct merger or conversion of a FICU into a stock issuing bank may have potential advantages. For example, it would enable a FICU that anticipates the need to eventually issue stock as a bank to accomplish this goal in a more efficient one-step process as opposed to the typical two-step process (FICU to MSB then MSB to stock bank) that has been the pattern in recent years in the FICU to MSB conversion scenario. Another advantage of a rule permitting these types of transactions is that it could be structured in a manner to give economic protection to members by making certain they share in the distribution of cash, free stock, or transferable stock subscription rights as compensation for their equity interest in their credit union. A potential issue with a rule for these transactions is that the rule would likely be complex because it would need to cover:
(1)Both mergers and conversions;
(2)charter changes to federal and state banks; and
(3)charter changes to freestanding stock banks and those within a mutual holding company structure or stock holding company structure. NCUA requests comment on whether it should issue a rule regulating these transactions or continue to address them under NCUA's statutory authority on an as-needed basis. If a commenter is in favor of NCUA issuing a rule, the commenter should also suggest how the rule could be structured, how NCUA should address the four issues discussed in B.2. below in the context of the rule, and what other issues should be addressed. 2. Issues NCUA believes there are significant issues affecting member interests arising across the spectrum of the restructuring transactions contemplated in this ANPR, including those for which NCUA currently has regulations in place and those, discussed above, for which it does not. This ANPR sets out the issues for comment in four categories: Management's Duties, Member Right to Equity, Communications to Members, and Member Voting. NCUA is interested in receiving comments on how its regulations should best address these issues. A discussion of the issues follows. *(a) Management's Duties.* In this category, the ANPR seeks comment on two issues: the need for a regulation to address the fiduciary duty credit union directors owe to members and the need for additional regulatory provisions to guard against insider enrichment.
(i)Fiduciary Duty A credit union's board of directors has a fiduciary duty to act in the best interests of its members. 1 The Act makes numerous references to the NCUA Board's responsibility to act in the best interests of credit union members, including: 1 This duty is based on the relationship of trust and confidence between the members and directors and arises because members' property is entrusted to the entity to be managed for the members benefit. Jean E. Maess, J.D., Corpus Juris Secundum 47 (2007). • The NCUA Board may act to remove or prohibit any institution-affiliated party at a FICU if that action meets certain requirements, including that the “interests of the insured credit union's members have been or could be prejudiced.” 12 U.S.C. 1787(g)(1)(B). • Credit unions applying for federal account insurance must agree to maintain such special reserves as the NCUA Board may require “for protecting the interests of the members.” 12 U.S.C. 1781(b)(6). • The NCUA Board must review the application of any individual to become a director or senior manager at a newly chartered or troubled FICU, and disapprove that application, if acceptance of the applicant would not be in the best interests of the depositors (members). 12 U.S.C. 1790a. • When acting as the conservator or liquidating agent of a FICU, the NCUA Board may take any action it determines is in the best interests of the credit union's account holders (members). 12 U.S.C. 1787(b)(2)(J)(2). As discussed in a previous rulemaking, although referring specifically to the NCUA Board, these provisions support the conclusion that credit union directors have a fiduciary obligation to credit union members. 71 FR 77150 (December 22, 2006). A closer look at how the cited provisions function, however, connects them to the [credit union's board of] directors. Specifically, the best interests of the members will dictate the [NCUA] Board's actions when removing or prohibiting a director, approving the appointment of a director, operating a conserved credit union in the role of the board of directors, and reviewing the propriety of a board of directors' decision to pursue a voluntary liquidation. If the best interests of the members standard guides the conduct of the [NCUA] Board, it must also guide the conduct of [the credit union's board of] directors. *Id.* While it is important for a credit union's board of directors to understand its duty to act in the best interests of the members in the ordinary course of business, NCUA believes it is especially important when the board is considering a proposal to change the credit union's charter or insurance status. These extraordinary transactions not only result in a fundamental shift in the credit union, but tend to present more conflicts between member interests and the personal financial interests of credit union management. While the existence of a fiduciary duty owed by directors to members is clear, neither the Act nor NCUA regulations establish or provide any guidance as to what that standard of care is for directors. NCUA is considering establishing a regulatory standard of care for directors that will help ensure they meet their fiduciary duty to their members when directors are making decisions in connection with the transactions discussed in this ANPR. NCUA has considered the standards of care that have developed in this area of the law, which, to a great extent, have developed in case law, applying fiduciary principles not only to situations involving trusts, but also in the corporate context. The result is that a credit union board currently must look to state law and case law to understand the scope of its fiduciary duties to members and the standard of care required as articulated by its particular state. Unfortunately, case law and state law can vary widely from jurisdiction to jurisdiction causing confusion for credit unions and a lack of uniformity between credit unions in one state and others in other states. As a result, the standard of care applying to these transactions can span a broad spectrum ranging from only requiring a board of directors to have a rational basis for making a decision to requiring the board to demonstrate that its decisions are made in the best interests of its members and based on a full consideration and documented analysis of all the alternatives. Considering the unique interests, concerns, and structure of credit unions as financial cooperatives, NCUA believes having a uniform federal standard may be useful to eliminate confusion resulting from differences in state law and may make it easier for credit union boards to fulfill their duties to members. NCUA solicits comment on whether it should establish, by regulation, a uniform federal standard of care for the transactions discussed in this ANPR, including specific suggestions on the standard that should be applied and if there should be a separate standard of care for transactions where the credit union member will no longer be a member of a credit union.
(ii)Insider Enrichment NCUA's experience with FICU to MSB conversions suggests that in some cases credit union officials have pursued personal enrichment to the detriment of members, and NCUA has issued disclosure requirements to make members aware of the potential for this. NCUA is aware of conversion transactions where family members of credit union officials had joined the credit union in noticeable numbers prior to the conversion. These new members, who may be motivated to share in the profits from an eventual sale of stock, can also skew the member vote on conversion in some instances, especially in a close vote. NCUA is considering specific regulatory requirements regarding the record date for members voting on a conversion proposal or other transaction to prevent this problem. NCUA is interested in comments on any aspect of this issue.
(b)Member Right to Equity. NCUA is broadly considering the issue of how to deal with unequal net worth ratios among merging credit unions. This imbalance may result in unfair treatment of members of a credit union with a higher net worth. One method NCUA is considering to address this issue is to require a merger dividend. Another option could be to simply require the board of directors of a merging credit union to consider this issue as part of its due diligence, come to its own conclusion, and then justify that decision to its members. Generally, federal credit unions may only return net worth to members in the form of dividends or a return of interest. 12 U.S.C. 1761b, 1763. Dividends must be based on an account balance as of a specific date or calculated over a period of time, whether a month, a quarter, or several years. 12 CFR 707.7(a), Appendix B (b). Often, credit unions undertake a calculation of a dividend going back for a period of years to permit a credit union to reward long-time members. As noted, a merging credit union often has a higher net worth ratio than the continuing credit union. Also, a merging credit union may have other valuable characteristics for which the continuing credit union is willing to pay a premium, such as a complementary field of membership, thus increasing the net worth of the merging credit union in the context of the merger. In recent merger transactions, issues about merger dividends, also sometimes called a “share adjustment” and “capital equalization,” have arisen because of the nature of dividends in credit unions. NCUA's Office of General Counsel has addressed this issue and concluded that so-called “per capita” dividends (a flat amount paid to all members) are legally impermissible. OGC Op. 07-0410 (April 13, 2007), OGC Op. 97-0813 (September 29, 1997). NCUA recognizes that requiring a merger dividend or other return of interest in certain circumstances could include the following advantages:
(1)Rewarding the merging credit union's members;
(2)equalizing an imbalance in net worth between the credit unions, although this could lessen the merging credit union's value to the continuing credit union; and
(3)establishing a consistent approach (e.g., setting a record date or dividend period, identifying the kinds of accounts to receive the merger dividend, and so forth). On the other hand, NCUA recognizes that not imposing a merger dividend requirement in this area allows credit unions the flexibility to decide for themselves whether to include a merger dividend as part of their due diligence and negotiations and leaves calculation of any dividend to the merging credit unions, essentially allowing market forces and the wishes of the members to determine if a dividend is appropriate. The Board notes that, in a recent FICU to stock bank merger, the merging FICU returned to its members their equity interest in the credit union plus a premium, and the Board believes a return of equity can be a fair way to compensate members for the loss of the credit union they own. In other transactions, such as FICU to MSB conversions, NCUA has noticed that many of the converting credit unions seek to convert at a time when their net worth is high. In some instances, the conversion appears timed to occur after a period where the credit union has purposefully acted to increase its net worth. NCUA believes that, in those instances where excess equity has been built up, fairness to members may dictate payment of some equity to members of a merging or converting credit union instead of transferring it to a new institution where the credit union members will have less control and have diluted or no ownership interests. NCUA seeks comment on all possible options for dealing with this issue either as an amendment to current regulations or by issuing a new regulation. *(c) Communications to Members: Improper or Misleading Communications to Members.* NCUA fully supports members' rights to vote, in accordance with the Act, to make changes to their charter or account insurance but believes the linchpin in these transactions is that communications to members regarding the risks and benefits of the transactions must be accurate, sufficiently comprehensive, and not misleading. NCUA encourages a FICU converting to an MSB to communicate freely with its members. There are no limits or restrictions on the number or kind of communications, provided the communications are accurate and not misleading and otherwise comply with NCUA's rules for written member communications. An example of an improper, conversion-related communication is one that implies NCUA endorses the conversion or conversion-related materials. In a recent conversion transaction, NCUA discovered a credit union made this kind of improper communication to its members. Although the instances in which this issue has been most prevalent are FICU to MSB conversions, it also could arise in any transaction in which a credit union sends materials to its members, such as federal to private insurance conversions and FICU to bank mergers. NCUA is considering the need for a regulatory provision that specifically prohibits communications from credit union officials that state or imply that NCUA has endorsed the charter change transaction or accompanying credit union materials. NCUA is also considering requiring a credit union to include a statement in its materials to that effect, namely, that NCUA has not endorsed the transaction. NCUA requests comment in this regard. In a charter change transaction, a credit union may communicate with its members about the kind and quality of services it will provide after completion of the transaction. For example, a credit union may close or move branch offices or modify other services available to members, such as ATM services. It may choose to do this as a cost savings measure, to achieve better compatibility with the continuing financial institution, or for other reasons. In the FICU to MSB conversion context, a converting credit union may be legally required to close or move a branch located in a federal building that has been provided by a federal agency on a rent-free and utility-free basis. 2 Under any of these circumstances, members may face the diminution of services or have less convenient access to them. 2 The Act authorizes federal agencies to provide federal credit unions space in federal buildings on a rent-free and utility-free basis if certain conditions are met. 12 U.S.C. 1770. The key condition is that “at least 95 percent of the membership of the credit union to be served by the allotment of space * * * is composed of persons who either are presently federal employees or were federal employees at the time of their admission into the credit union, and members of their families * * *” See also 41 CFR 102-79.40. MSBs do not have any similar authority, although it appears that, under General Service Administration regulations, commercial entities, including banks, can lease space on a rental basis in publicly-accessible areas of federal buildings. An issue in a past FICU to MSB conversion was whether the credit union would be legally required to close or move a number of its rent-free branches located in federal buildings. In that transaction, the credit union made what appeared to be potentially inaccurate statements about its ability to continue to operate the branches in the same locations following conversion to an MSB. In another FICU to MSB conversion, the credit union made arguably misleading statements to members about its ability to continue to participate in a shared branch/shared service center network after conversion. In that transaction, the credit union told its members it was seeking approval to obtain post-conversion access to the network but failed to disclose that its request could be denied resulting in the members not having access to the network. Members need full and accurate information about a conversion to cast an informed vote, including if the transaction will result in the credit union closing or moving branches, losing access to shared branch/shared service center networks, or modifying other services available to members. NCUA is considering requiring converting credit unions to research this aspect of a transaction and disclose their findings to members. Alternatively, NCUA could issue a more general rule to address the need for full and accurate information. NCUA solicits comments on all aspects of this issue. Another communications issue, which NCUA's rules do not specifically address, is the so-called “hostile takeover” scenario, where an institution communicates directly with the members of a target credit union to encourage a merger or other consolidation. 3 In the credit union context, the term “hostile takeover” may be a misnomer because there is no saleable stock. Generally, a hostile takeover refers to a takeover of a target company against the wishes of the target's management and board of directors through the purchase of a controlling interest in the target's stock. Failed merger negotiations between two federal credit unions recently resulted in the potential acquiring credit union communicating directly with the potentially merging credit union's members in a fashion that was deemed hostile by the management of the target credit union. 3 Outside of the credit union context, where there is a tender offer for stock of a public company (the mechanism by which a hostile bidder solicits the stockholders of the target), it triggers the provisions of the Securities Exchange Act of 1934 and Securities and Exchange Commission
(SEC)rules. These provisions address communications by third parties to stockholders and, as noted in OGC Op 07-0342 (April 6, 2007), those SEC provisions provide detailed requirements regarding disclosures, tender offers, and other matters. SEC oversight in this regard helps protect stockholders by ensuring they are informed with accurate information about the transaction. NCUA could consider addressing third party merger communications by relying on current regulations or issuing a new regulation. As noted above, NCUA regulations do not directly address this situation, although part 740 prohibits a FICU from using any advertising or making any representation that is inaccurate or deceptive or in any way misrepresents its services, contracts, or financial condition. 12 CFR Part 740. The limitations of current regulations such as Part 708b and Part 740 are also, in part, that they only extend to insured credit unions. While a new regulation addressing mergers by a hostile institution may be more effective than the *status quo,* it would not be without its own limitations. Specifically, NCUA has no direct jurisdiction over communications by non-credit union institutions with credit union members. Alternatively, an approach could be to establish communication standards that would have to be met as a condition of NCUA approval of a merger. NCUA seeks comment on this topic in general and regulatory approaches to protecting the interests of credit union members in this context.
(d)*Member Voting: Right to Request a Recount and Use of Interim Tallies.* For the transactions that are the subject of this ANPR, NCUA is considering permitting any member of a credit union to request a formal recount of the vote in any situation in which the margin of decision is less than a certain percentage of the total votes cast. NCUA has not determined the appropriate margin for triggering recount rights and believes examining state law on political vote recounts in this regard could be appropriate and useful. NCUA is also considering a recount provision if sufficient evidence exists that the original vote tabulation is unreliable. NCUA has reviewed the voting procedures of a number of close votes in recent years. In those cases, NCUA found irregularities and improprieties that called into question the reliability of the vote. Examples of problems found include the credit union or its agent: Failing to compile a proper membership list thereby excluding some members from the vote; improperly excluding members from voting for causing a loss to the credit union; allowing individuals not fully qualified as members to vote; improperly handling mail ballots returned as undeliverable; employing poor internal controls in securing, counting, and recording votes; using inconsistent procedures for determining if a vote cast was invalid; and being generally unable to reconcile the tally. An unreliable voting process, whether intentionally manipulated or the result of incompetence, deprives members of their right to choose the fate of their credit union. NCUA requests comment on providing members the right to request a recount, under what circumstances and criteria a recount should be undertaken, and procedures for exercising such a right. The use by management of an interim vote tally presently is primarily an issue in the FICU to MSB conversion context but could be an issue anytime management has an interest in influencing the outcome of a membership vote. NCUA has observed in the voting procedures in some FICU to MSB conversions that credit union management seek periodic running tallies from the election teller as to how many members have voted yes and no and which members have not voted. Credit union management has justified this practice by stating they only use the information for the purpose of encouraging members to vote. In investigations of recent conversions, NCUA has discovered that, in practice, some credit unions use this information only for encouraging votes in favor of the conversion. This violates both Part 708a and typical credit union policies aimed at neutrality in this regard. For example, some credit unions have pressured, required, or paid employees to encourage members to vote in favor of conversion even where the employees did not wish to do so or did not believe conversion was in the members' best interests. NCUA has learned that some credit unions have targeted likely “yes” voters in an attempt to sway the vote in favor of conversion. Other tactics include determining how a member voted in violation of the voting secrecy requirement, using periodic voting tallies to management's advantage and to the disadvantage of those members opposed to the conversion by not sharing that information with members, and improperly handling ballots for members instead of having members mail them directly to the independent election teller. NCUA is considering:
(1)Prohibiting credit union management from obtaining interim voting tallies from the election teller;
(2)prohibiting credit union management from obtaining lists of members who have not voted from the election teller;
(3)prohibiting credit union employees from soliciting members to vote; and
(4)prohibiting credit union employees from completing member ballots or otherwise handling ballots. NCUA would appreciate comments on these means for ensuring the integrity of the voting process. Request for Comments The NCUA Board invites comment on any of the issues discussed above including:
(1)If NCUA's regulations should be amended to address the issues discussed in this ANPR;
(2)if NCUA should promulgate new regulations for credit union merger or conversion into a financial institution other than an MSB and, if so, what those regulations should cover; and
(3)any other relevant issues NCUA has not considered. By the National Credit Union Administration Board on January 24, 2008. Mary F. Rupp, Secretary of the Board. [FR Doc. E8-1572 Filed 1-29-08; 8:45 am] BILLING CODE 7535-01-P LIBRARY OF CONGRESS Copyright Royalty Board 37 CFR Part 384 [Docket No. 2007-1 CRB DTRA-BE] Determination of Rates and Terms for Business Establishment Services AGENCY: Copyright Royalty Board, Library of Congress. ACTION: Notice of proposed rulemaking. SUMMARY: The Copyright Royalty Judges are publishing for comment proposed regulations that set the rates and terms for the making of an ephemeral recording of a sound recording by a business establishment service for the period 2009-2013. DATES: Comments and objections, if any, are due no later than February 29, 2008. ADDRESSES: Comments and objections may be sent electronically to *crb@loc.gov.* In the alternative, send an original, five copies and an electronic copy on a CD either by mail or hand delivery. Please do not use multiple means of transmission. Comments and objections may not be delivered by an overnight delivery service other than the U.S. Postal Service Express Mail. If by mail (including overnight delivery), comments and objections must be addressed to: Copyright Royalty Board, P.O. Box 70977, Washington, DC 20024-0977. If hand delivered by a private party, comments and objections must be brought to the Copyright Office Public Information Office, Library of Congress, James Madison Memorial Building, Room LM-401, 101 Independence Avenue, SE., Washington, DC 20559-6000. If delivered by a commercial courier, comments and objections must be delivered between 8:30 a.m. and 4 p.m. to the Congressional Courier Acceptance Site located at 2nd and D Street, NE., Washington, DC, and the envelope must be addressed to: Copyright Royalty Board, Library of Congress, James Madison Memorial Building, LM-403, 101 Independence Avenue, SE., Washington, DC 20559-6000. FOR FURTHER INFORMATION CONTACT: Richard Strasser, Senior Attorney, or Gina Giuffreda, Attorney-Advisor, by telephone at
(202)707-7658 or e-mail at *crb@loc.gov.* SUPPLEMENTARY INFORMATION: Background In 1995, Congress enacted the Digital Performance in Sound Recordings Act, Public Law No. 104-39, which created an exclusive right for copyright owners of sound recordings, subject to certain limitations, to perform publicly sound recordings by means of certain digital audio transmissions. Among the limitations on the performance right was the creation of a statutory license for nonexempt, noninteractive digital subscription transmissions. 17 U.S.C. 114(d). The scope of the section 114 statutory license was expanded in 1998 upon passage of the Digital Millennium Copyright Act of 1998 (“DMCA”), Pub. L. No. 105-304, in order to allow for the public performance of a sound recording when made in accordance with the terms and rates of the statutory license, 17 U.S.C. 114(d), by a preexisting satellite digital audio radio service or as part of an eligible nonsubscription transmission. In addition to expanding the section 114 license, the DMCA also created a statutory license for the making of an “ephemeral recording” of a sound recording by certain transmitting organizations. 17 U.S.C. 112(e). This license allows entities that transmit performances of sound recordings to business establishments, pursuant to the limitations set forth in section 114(d)(1)(C)(iv), to make an ephemeral recording of a sound recording for a later transmission. *Id.* The license also provides a means by which a transmitting entity with a statutory license under section 114(f) can make more than the one phonorecord permitted under the exemption set forth in section 112(a). 17 U.S.C. 112(e). The rates and terms for the making of ephemeral recordings of sound recordings by a business establishment service have been adjusted periodically by the Librarian of Congress and appear in 37 CFR Parts 261 and 262. However, the Copyright Royalty and Distribution Reform Act of 2004 (“CRDRA”), Public Law No. 108-419, transferred jurisdiction over these rates and terms to the Copyright Royalty Judges (“Judges”). 17 U.S.C. 801(b)(1). The current rates for this license set forth in 37 CFR Part 262 will remain in effect until December 31, 2008. *See* Section 6(b)(3) of the CRDRA (rates and terms for section 112(e) in effect on December 31, 2004, “shall remain in effect until the later of the first applicable effective date for successor terms and rates specified in [17 U.S.C.] section 804(b)(2)”); 17 U.S.C. 804(b)(2)(successor rates to become effective on January 1, 2009). On January 5, 2007, pursuant to 17 U.S.C. 803(b)(1)(A)(i)(II), the Copyright Royalty Judges published a notice in the **Federal Register** announcing commencement of the proceeding to determine rates and terms of royalty payments for the making of ephemeral recordings by business establishment services under section 112(e) and requesting interested parties to submit their petitions to participate. 72 FR 584 (January 5, 2007). Petitions to participate in this proceeding were received from Music Choice, Royalty Logic, Inc. (“RLI”), Muzak, LLC, SoundExchange, Inc., Sirius Satellite Radio, Inc. (“Sirius”), and XM Satellite Radio (“XM”). The Judges set the timetable for the three-month negotiation period, *see* 17 U.S.C. 803(b)(3), and directed the participants to submit their written direct statements no later than October 31, 2007. On October 31, 2007, the Judges received a notice of settlement entered into by all parties to the proceeding, with the exception of Muzak, which had withdrawn from the proceeding on October 5, 2007, and RLI. Accompanying the notice of settlement was a motion by SoundExchange requesting that the Judges adopt the proposed rates and terms. SoundExchange also filed its written direct statement, given that RLI had not agreed to the proposed settlement. RLI did not file a written direct statement or an opposition to SoundExchange's motion. Prior to a ruling on the motion to publish the proposed rates and terms for notice and comment, SoundExchange filed a motion to dismiss RLI from this proceeding for failure to file a written direct statement and renewed its request that the Judges issue a notice of proposed rulemaking seeking comment on the proposed rates and terms. *See* Motion filed November 28, 2007. The Judges received no opposition to this motion from RLI. Consequently, on December 6, 2007, the Judges granted SoundExchange's motion and dismissed RLI from this proceeding. *See* , Order Granting SoundExchange's Motion to Dismiss Royalty Logic, Inc., in Docket No. 2007-1 CRB DTRA-BE (December 6, 2007). Since all remaining parties to this proceeding have agreed to the settlement, the Judges are publishing the proposed rates and terms for notice and comment pursuant to their authority under 17 U.S.C. 801(b)(7)(A). Section 801(b)(7)(A) allows for the adoption of rates and terms negotiated by “some or all of the participants in a proceeding at any time during the proceeding” provided they are submitted to the Copyright Royalty Judges for approval. This section provides that in such event:
(i)the Copyright Royalty Judges shall provide to those that would be bound by the terms, rates, or other determination set by any agreement in a proceeding to determine royalty rates an opportunity to comment on the agreement and shall provide to participants in the proceeding under section 803(b)(2) that would be bound by the terms, rates, or other determination set by the agreement an opportunity to comment on the agreement and object to its adoption as a basis for statutory terms and rates; and
(ii)the Copyright Royalty Judges may decline to adopt the agreement as a basis for statutory terms and rates for participants that are not parties to the agreement, if any participant described in clause
(i)objects to the agreement and the Copyright Royalty Judges conclude, based on the record before them if one exists, that the agreement does not provide a reasonable basis for setting statutory terms or rates. 17 U.S.C. 801(b)(7)(A). Rates and terms adopted pursuant to this provision are binding on all copyright owners of sound recordings and business establishment services making an ephemeral recording of a sound recording for the period 2009-2013. As discussed above, the public may comment and object to any or all of the proposed regulations contained in this notice of proposed rulemaking. Those who do comment and object, however, must be prepared to participate in further proceedings in this docket to set rates and terms for the making of ephemeral recordings by business establishment services. List of Subjects in 37 CFR Part 384 Copyright, Digital audio transmissions, Ephemeral recordings, Performance right, Sound recordings. Proposed Regulations For the reasons set forth in the preamble, the Copyright Royalty Judges propose to add part 384 to Chapter III of title 37 of the Code of Federal Regulations to read as follows: PART 384—RATES AND TERMS FOR THE MAKING OF EPHEMERAL RECORDINGS BY BUSINESS ESTABLISHMENT SERVICES Sec. 384.1 General. 384.2 Definitions. 384.3 Royalty fees for Ephemeral Recordings. 384.4 Terms for making payment of royalty fees and statements of account. 384.5 Confidential information. 384.6 Verification of royalty payments. 384.7 Verification of royalty distributions. 384.8 Unclaimed funds. Authority: 17 U.S.C. 112(e), 801(b)(1). § 384.1 General.
(a)*Scope.* This part 384 establishes rates and terms of royalty payments for the making of Ephemeral Recordings by a Business Establishment Service, as defined in § 384.2(a), in accordance with the provisions of 17 U.S.C. 112(e), during the period 2009-2013 (the “License Period”).
(b)*Legal compliance.* Licensees relying upon the statutory licenses set forth in 17 U.S.C. 112 shall comply with the requirements of that section, the rates and terms of this part and any other applicable regulations.
(c)*Relationship to voluntary agreements.* Notwithstanding the royalty rates and terms established in this part, the rates and terms of any license agreements entered into by Copyright Owners and services shall apply in lieu of the rates and terms of this part to the making of Ephemeral Recordings within the scope of such agreements. § 384.2 Definitions. For purposes of this part, the following definitions shall apply: *Business Establishment Service* means a service making transmissions of sound recordings under the limitation on exclusive rights specified by 17 U.S.C. 114(d)(1)(C)(iv). *Collective* is the collection and distribution organization that is designated by the Copyright Royalty Judges. For the License Period, the Collective is SoundExchange, Inc. *Copyright Owner* is a sound recording copyright owner who is entitled to receive royalty payments made under this part pursuant to the statutory license under 17 U.S.C. 112(e). *Ephemeral Recording* is a phonorecord created for the purpose of facilitating a transmission of a public performance of a sound recording under the limitations on exclusive rights specified by 17 U.S.C. 114(d)(1)(C)(iv), and subject to the limitations specified in 17 U.S.C. 112(e). *Licensee* is a Business Establishment Service that has obtained a compulsory license under 17 U.S.C. 112(e) and the implementing regulations therefor to make Ephemeral Recordings. *Performers* means the independent administrators identified in 17 U.S.C. 114(g)(2)(B) and
(C)and the parties identified in 17 U.S.C. 114(g)(2)(D). *Qualified Auditor* is a certified public accountant. § 384.3 Royalty fees for Ephemeral Recordings.
(a)*Basic royalty rate.* For the making of any number of Ephemeral Recordings in the operation of a service pursuant to the limitation on exclusive rights specified by 17 U.S.C. 114(d)(1)(C)(iv), a Licensee shall pay 10% of such Licensee's “Gross Proceeds” derived from the use in such service of musical programs that are attributable to copyrighted recordings. “Gross Proceeds” as used in this section means all fees and payments, including those made in kind, received from any source before, during or after the License Period that are derived from the use of copyrighted sound recordings during the License Period pursuant to 17 U.S.C. 112(e) for the sole purpose of facilitating a transmission to the public of a performance of a sound recording under the limitation on exclusive rights specified in 17 U.S.C. 114(d)(1)(C)(iv). The attribution of Gross Proceeds to copyrighted recordings may be made on the basis of:
(1)For classical programs, the proportion that the playing time of copyrighted classical recordings bears to the total playing time of all classical recordings in the program, and
(2)For all other programs, the proportion that the number of copyrighted recordings bears to the total number of all recordings in the program.
(b)*Minimum fee.* Each Licensee shall pay a minimum fee of $10,000 for each calendar year in which it makes Ephemeral Recordings for use to facilitate transmissions under the limitation on exclusive rights specified by 17 U.S.C. 114(d)(1)(C)(iv), whether or not it does so for all or any part of the year. These minimum fees shall be nonrefundable, but shall be fully creditable to royalty payments due under paragraph
(a)of this section for the same calendar year (but not any subsequent calendar year).
(c)*Other royalty rates and terms.* This part 384 does not apply to persons or entities other than Licensees, or to Licensees to the extent that they make other types of ephemeral recordings beyond those set forth in paragraph
(a)of this section. For ephemeral recordings other than those governed by paragraph
(a)of this section, persons making such ephemeral recordings must pay royalties, to the extent (if at all) applicable, under 17 U.S.C. 112(e) or as prescribed by other law, regulation or agreement. § 384.4 Terms for making payment of royalty fees and statements of account.
(a)*Payment to Collective.* A Licensee shall make the royalty payments due under § 384.3 to the Collective.
(b)*Designation of the Collective.*
(1)Until such time as a new designation is made, SoundExchange, Inc., is designated as the Collective to receive statements of account and royalty payments from Licensees due under § 384.3 and to distribute such royalty payments to each Copyright Owner, or their designated agents, entitled to receive royalties under 17 U.S.C. 112(e).
(2)If SoundExchange, Inc. should dissolve or cease to be governed by a board consisting of equal numbers of representatives of Copyright Owners and Performers, then it shall be replaced by a successor Collective upon the fulfillment of the requirements set forth in paragraph (b)(2)(i) of this section.
(i)By a majority vote of the nine Copyright Owner representatives and the nine Performer representatives on the SoundExchange board as of the last day preceding the condition precedent in paragraph (b)(2) of this section, such representatives shall file a petition with the Copyright Royalty Judges designating a successor to collect and distribute royalty payments to Copyright Owners entitled to receive royalties under 17 U.S.C. 112(e) that have themselves authorized such Collective.
(ii)The Copyright Royalty Judges shall publish in the **Federal Register** within 30 days of receipt of a petition filed under paragraph (b)(2)(i) of this section an order designating the Collective named in such petition.
(c)*Monthly payments.* A Licensee shall make any payments due under § 384.3(a) by the 45th day after the end of each month for that month, except that if the Copyright Royalty Judges issue their final determination adopting these rates and terms after the commencement of the License Period, then payments due under § 384.3(a) for the period from the beginning of the License Period through the last day of the month in which the Copyright Royalty Judges issue their final determination adopting these rates and terms shall be due 45 days after the end of such period. All monthly payments shall be rounded to the nearest cent.
(d)*Minimum payments.* A Licensee shall make any payment due under § 384.3(b) by January 31 of the applicable calendar year, except that:
(1)If the Copyright Royalty Judges issue their final determination adopting these rates and terms after the commencement of the License Period, then payment due under § 384.3(b) for 2009 shall be due 45 days after the last day of the month in which these rates and terms are adopted by the Copyright Royalty Judges and published in the **Federal Register** ; and
(2)Payment for a Licensee that has not previously made Ephemeral Recordings pursuant to the license under 17 U.S.C. 112(e) shall be due by the 45th day after the end of the month in which the Licensee commences to do so.
(e)*Late payments.* A Licensee shall pay a late fee of 0.75% per month, or the highest lawful rate, whichever is lower, for any payment received by the Collective after the due date. Late fees shall accrue from the due date until payment is received by the Collective.
(f)*Statements of account.* For any part of the period beginning on the date the Copyright Royalty Judges issue their final determination adopting these rates and terms and ending on December 31, 2013, during which a Licensee operates a Business Establishment Service, by 45 days after the end of each month during the period, the Licensee shall deliver to the Collective a statement of account containing the information set forth in this paragraph
(f)on a form prepared, and made available to Licensees, by the Collective. If a payment is owed for such month, the statement of account shall accompany the payment. A statement of account shall contain only the following information:
(1)Such information as is necessary to calculate the accompanying royalty payment, or if no payment is owed for the month, to calculate any portion of the minimum fee recouped during the month;
(2)The name, address, business title, telephone number, facsimile number, electronic mail address and other contact information of the individual or individuals to be contacted for information or questions concerning the content of the statement of account;
(3)The handwritten signature of:
(i)The owner of the Licensee or a duly authorized agent of the owner, if the Licensee is not a partnership or a corporation;
(ii)A partner or delegee, if the Licensee is a partnership; or
(iii)An officer of the corporation, if the Licensee is a corporation;
(4)The printed or typewritten name of the person signing the statement of account;
(5)The date of signature;
(6)If the Licensee is a partnership or a corporation, the title or official position held in the partnership or corporation by the person signing the statement of account;
(7)A certification of the capacity of the person signing; and
(8)A statement to the following effect: I, the undersigned owner or agent of the Licensee, or officer or partner, if the Licensee is a corporation or partnership, have examined this statement of account and hereby state that it is true, accurate and complete to my knowledge after reasonable due diligence.
(g)*Distribution of payments.* The Collective shall distribute royalty payments directly to Copyright Owners; Provided that the Collective shall only be responsible for making distributions to those Copyright Owners who provide the Collective with such information as is necessary to identify and pay the correct recipient of such payments. The Collective shall distribute royalty payments on a basis that values all Ephemeral Recordings by a Licensee equally based upon the information provided by the Licensee pursuant to the regulations governing reports of use of sound recordings by Licensees; Provided, however, that Copyright Owners that authorize the Collective may agree with the Collective to allocate their shares of the royalty payments made by any Licensee among themselves on an alternative basis. Copyright Owners entitled to receive payments may agree with the Collective upon payment protocols to be used by the Collective that provide for alternative arrangements for the payment of royalties.
(h)*Permitted deductions.* The Collective may deduct from the payments made by Licensees under § 384.3, prior to the distribution of such payments to any person or entity entitled thereto, all incurred costs permitted to be deducted under 17 U.S.C. 114(g)(3); Provided, however, that any party entitled to receive royalty payments under 17 U.S.C. 112(e) may agree to permit the Collective to make any other deductions.
(i)*Retention of records.* Books and records of a Licensee and of the Collective relating to the payment, collection, and distribution of royalty payments shall be kept for a period of not less than 3 years. § 384.5 Confidential Information.
(a)*Definition.* For purposes of this part, “Confidential Information” shall include the statements of account, any information contained therein, including the amount of royalty payments, and any information pertaining to the statements of account reasonably designated as confidential by the Licensee submitting the statement.
(b)*Exclusion.* Confidential Information shall not include documents or information that at the time of delivery to the Collective are public knowledge. The Collective shall have the burden of proving that the disclosed information was public knowledge.
(c)*Use of Confidential Information.* In no event shall the Collective or any other person or entity authorized to have access to Confidential Information pursuant to paragraph
(d)of this section use any Confidential Information for any purpose other than royalty collection and distribution and activities directly related thereto.
(d)*Disclosure of Confidential Information.* Access to Confidential Information shall be limited to:
(1)Those employees, agents, attorneys, consultants and independent contractors of the Collective, subject to an appropriate confidentiality agreement, who are engaged in the collection and distribution of royalty payments hereunder and activities related thereto, who are not also employees or officers of a Copyright Owner or Performer, and who, for the purpose of performing such duties during the ordinary course of their work, require access to the records;
(2)Board members of the Collective, and members of Collective committees whose primary functions are directly related to royalty collection and distribution, subject to an appropriate confidentiality agreement and for the sole purpose of performing their duties as board or committee members of the Collective, as applicable, provided that the sole confidential information that may be shared pursuant to this paragraph (d)(2) is confidential information contained in monthly statements of accounts provided pursuant to § 384.4(f) that accompany royalty payments;
(3)An independent and Qualified Auditor, subject to an appropriate confidentiality agreement, who is authorized to act on behalf of the Collective with respect to the verification of a Licensee's royalty payments pursuant to § 384.6 or on behalf of a Copyright Owner with respect to the verification of royalty distributions pursuant to § 384.7;
(4)Copyright owners whose works have been used under the statutory license set forth in 17 U.S.C. 112(e) by the Licensee whose Confidential Information is being supplied, or agents thereof, subject to an appropriate confidentiality agreement, provided that the sole confidential information that may be shared pursuant to paragraph (d)(4) of this section are monthly statements of account provided pursuant to § 384.4(f) that accompany royalty payments;
(5)In connection with future proceedings under 17 U.S.C. 112(e) before the Copyright Royalty Judges, and under an appropriate protective order, attorneys, consultants and other authorized agents of the parties to the proceedings or the courts; and
(6)In connection with bona fide royalty disputes or claims that are the subject of the procedures under § 384.6 or § 384.7, and under an appropriate confidentiality agreement or protective order, the specific parties to such disputes or claims, their attorneys, consultants or other authorized agents, and/or arbitration panels or the courts to which disputes or claims may be submitted.
(e)*Safeguarding of Confidential Information.* The Collective and any person or entity identified in paragraph
(d)of this section shall implement procedures to safeguard all Confidential Information using a reasonable standard of care, but no less than the same degree of security used to protect Confidential Information or similarly sensitive information belonging to such Collective, person, or entity. § 384.6 Verification of royalty payments.
(a)*General.* This section prescribes procedures by which the Collective may verify the royalty payments made by a Licensee.
(b)*Frequency of verification.* The Collective may conduct a single audit of a Licensee, upon reasonable notice and during reasonable business hours, during any given calendar year, for any or all of the prior 3 calendar years, but no calendar year shall be subject to audit more than once.
(c)*Notice of intent to audit.* The Collective must file with the Copyright Royalty Judges a notice of intent to audit a particular Licensee, which shall, within 30 days of the filing of the notice, publish in the **Federal Register** a notice announcing such filing. The notification of intent to audit shall be served at the same time on the Licensee to be audited. Any such audit shall be conducted by an independent and Qualified Auditor identified in the notice, and shall be binding on all parties.
(d)*Acquisition and retention of records.* The Licensee shall use commercially reasonable efforts to obtain or to provide access to any relevant books and records maintained by third parties for the purpose of the audit and retain such records for a period of not less than 3 years. The Collective shall retain the report of the verification for a period of not less than 3 years.
(e)*Acceptable verification procedure.* An audit, including underlying paperwork, which was performed in the ordinary course of business according to generally accepted auditing standards by an independent and Qualified Auditor, shall serve as an acceptable verification procedure for all parties with respect to the information that is within the scope of the audit.
(f)*Consultation.* Before rendering a written report to the Collective, except where the auditor has a reasonable basis to suspect fraud and disclosure would, in the reasonable opinion of the auditor, prejudice the investigation of such suspected fraud, the auditor shall review the tentative written findings of the audit with the appropriate agent or employee of the Licensee being audited in order to remedy any factual errors and clarify any issues relating to the audit; Provided that the appropriate agent or employee of the Licensee reasonably cooperates with the auditor to remedy promptly any factual errors or clarify any issues raised by the audit.
(g)*Costs of the verification procedure.* The Collective shall pay the cost of the verification procedure, unless it is finally determined that there was an underpayment of 10% or more, in which case the Licensee shall, in addition to paying the amount of any underpayment, bear the reasonable costs of the verification procedure. § 384.7 Verification of royalty distributions.
(a)*General.* This section prescribes procedures by which any Copyright Owner may verify the royalty distributions made by the Collective; Provided, however, that nothing contained in this section shall apply to situations where a Copyright Owner and the Collective have agreed as to proper verification methods.
(b)*Frequency of verification.* A Copyright Owner may conduct a single audit of the Collective upon reasonable notice and during reasonable business hours, during any given calendar year, for any or all of the prior 3 calendar years, but no calendar year shall be subject to audit more than once.
(c)*Notice of intent to audit.* A Copyright Owner must file with the Copyright Royalty Judges a notice of intent to audit the Collective, which shall, within 30 days of the filing of the notice, publish in the **Federal Register** a notice announcing such filing. The notification of intent to audit shall be served at the same time on the Collective. Any such audit shall be conducted by an independent and Qualified Auditor identified in the notice, and shall be binding on all Copyright Owners.
(d)*Acquisition and retention of records.* The Collective shall use commercially reasonable efforts to obtain or to provide access to any relevant books and records maintained by third parties for the purpose of the audit and retain such records for a period of not less than 3 years. The Copyright Owner requesting the verification procedure shall retain the report of the verification for a period of not less than 3 years.
(e)*Acceptable verification procedure.* An audit, including underlying paperwork, which was performed in the ordinary course of business according to generally accepted auditing standards by an independent and Qualified Auditor, shall serve as an acceptable verification procedure for all parties with respect to the information that is within the scope of the audit.
(f)*Consultation.* Before rendering a written report to a Copyright Owner, except where the auditor has a reasonable basis to suspect fraud and disclosure would, in the reasonable opinion of the auditor, prejudice the investigation of such suspected fraud, the auditor shall review the tentative written findings of the audit with the appropriate agent or employee of the Collective in order to remedy any factual errors and clarify any issues relating to the audit; Provided that the appropriate agent or employee of the Collective reasonably cooperates with the auditor to remedy promptly any factual errors or clarify any issues raised by the audit.
(g)*Costs of the verification procedure.* The Copyright Owner requesting the verification procedure shall pay the cost of the procedure, unless it is finally determined that there was an underpayment of 10% or more, in which case the Collective shall, in addition to paying the amount of any underpayment, bear the reasonable costs of the verification procedure. § 384.8 Unclaimed funds. If a Collective is unable to identify or locate a Copyright Owner who is entitled to receive a royalty payment under this part, the Collective shall retain the required payment in a segregated trust account for a period of 3 years from the date of payment. No claim to such payment shall be valid after the expiration of the 3-year period. After the expiration of this period, the Collective may apply the unclaimed funds to offset any costs deductible under 17 U.S.C. 114(g)(3). The foregoing shall apply notwithstanding the common law or statutes of any State. Dated: January 24, 2008. James Scott Sledge, Chief Copyright Royalty Judge. [FR Doc. E8-1680 Filed 1-29-08; 8:45 am] BILLING CODE 1410-72-P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R05-OAR-2007-0183; FRL-8514-6] Approval and Promulgation of Air Quality Implementation Plans; Illinois; Revisions to Emission Reduction Market System AGENCY: Environmental Protection Agency (EPA). ACTION: Proposed rule. SUMMARY: In 1997, Illinois adopted and submitted rules establishing a cap and trade program regulating emissions of volatile organic compounds (VOC). The program was designed to address VOC sources in the Chicago area with potential to emit at least 25 tons per year. Then, in 2004, EPA replaced the “Severe” classification for the Chicago ozone nonattainment area with a “Moderate” classification, which according to EPA guidance revised the applicable definition of major sources from 25 tons per year to 100 tons per year. Illinois adopted rule revisions, submitted to EPA on January 10, 2007, to require that sources with potential to emit at least 25 tons per year remain in the program. Illinois' rule revisions also address other ramifications of the “reclassification.” EPA is approving these rule revisions. DATES: Comments must be received on or before February 29, 2008. ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R05-OAR-2007-0183, by one of the following methods: 1. *http://www.regulations.gov:* Follow the on-line instructions for submitting comments. 2. *E-mail:* *mooney.john@epa.gov* . 3. *Fax:*
(312)886-5824. 4. *Mail:* John M. Mooney, Chief, Criteria Pollutant Section, Air Programs Branch (AR-18J), U.S. Environmental Protection Agency, 77 West Jackson Boulevard, Chicago, Illinois 60604. 5. *Hand Delivery:* John M. Mooney, Chief, Criteria Pollutant Section, Air Programs Branch (AR-18J), U.S. Environmental Protection Agency, 77 West Jackson Boulevard, Chicago, Illinois 60604. Such deliveries are only accepted during the Regional Office normal hours of operation, and special arrangements should be made for deliveries of boxed information. The Regional Office official hours of business are Monday through Friday, 8:30 a.m. to 4:30 p.m. excluding Federal holidays. Please see the direct final rule which is located in the Rules section of this **Federal Register** for detailed instructions on how to submit comments. FOR FURTHER INFORMATION CONTACT: John Summerhays, Environmental Scientist, Criteria Pollutant Section, Air Programs Branch (AR-18J), Environmental Protection Agency, Region 5, 77 West Jackson Boulevard, Chicago, Illinois 60604,
(312)886-6067, *summerhays.john@epa.gov* . SUPPLEMENTARY INFORMATION: In the Final Rules section of this **Federal Register** , EPA is approving the State's SIP submittal as a direct final rule without prior proposal because the Agency views this as a noncontroversial submittal and anticipates no adverse comments. A detailed rationale for the approval is set forth in the direct final rule. If no adverse comments are received in response to this rule, no further activity is contemplated. If EPA receives adverse comments, the direct final rule will be withdrawn and all public comments received will be addressed in a subsequent final rule based on this proposed rule. EPA will not institute a second comment period. Any parties interested in commenting on this action should do so at this time. Please note that if EPA receives adverse comment on an amendment, paragraph, or section of this rule and if that provision may be severed from the remainder of the rule, EPA may adopt as final those provisions of the rule that are not the subject of an adverse comment. For additional information, see the direct final rule which is located in the Rules section of this **Federal Register** . Dated: December 18, 2007. Bharat Mathur, Acting Regional Administrator, Region 5. [FR Doc. E8-805 Filed 1-29-08; 8:45 am] BILLING CODE 6560-50-P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 147 [EPA-R08-OW-2007-0153; FRL-8522-5] Fort Peck Assiniboine and Sioux Tribes in Montana; Underground Injection Control
(UIC)Program; Proposed Primacy Approval and Minor Revisions AGENCY: Environmental Protection Agency. ACTION: Proposed rule. SUMMARY: The Environmental Protection Agency
(EPA)is proposing to approve an application from the Fort Peck Assiniboine and Sioux Tribes in Montana under Section 1425 of the Safe Drinking Water Act
(SDWA)to implement an underground injection control
(UIC)program for Class II (oil and gas-related) injection wells. EPA is also proposing minor revisions to regulations that are not specific to the Fort Peck Tribes' application. EPA requests public comment and has scheduled a public hearing on this application, the proposed rule, and EPA's supporting documentation. EPA will consider comments received at the public hearing and during the public comment period before taking final action. DATES: Comments must be received on or before February 29, 2008. The public hearing will be held at the Fort Peck Community College Auditorium located at 605 Indian Avenue in Poplar, Montana at 7 p.m. on Monday, February 25, 2008. ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R08-OW-2007-0153, by one of the following methods: • *http://www.regulations.gov:* Follow the on-line instructions for submitting comments. • *Mail:* Environmental Protection Agency, 8P-W-GW, 1595 Wynkoop Street, Denver, CO 80202-1129. • *Hand Delivery:* Deliver your comments to Douglas Minter, Environmental Protection Agency, 8P-W-GW, 1595 Wynkoop Street, Denver, CO 80202-1129, Attention Docket ID No. EPA-R08-OW-2007-0153. Such deliveries are only accepted during the Docket's normal hours of operation: Monday through Friday, between 8 a.m. and 4 p.m., excluding legal holidays. Special arrangements should be made for deliveries of boxed information. *Instructions:* Direct your comments to Docket ID No. EPA-R08-OW-2007-0153. EPA's policy is that all comments received will be included in the public docket without change and may be made available online at *http://www.regulations.gov* , including any personal information provided, unless the comment includes information claimed to be Confidential Business Information
(CBI)or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through *http://www.regulations.gov* or e-mail. The *http://www.regulations.gov* Web site is an “anonymous access” system, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an e-mail comment directly to EPA without going through *http://www.regulations.gov* , your e-mail address will be automatically captured and included as part of the comment that is placed in the public docket and made available on the Internet. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD-ROM you submit. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses. For additional information about EPA's public docket visit EPA's Docket Center homepage at *http://www.epa.gov/epahome/dockets.htm* . For additional instructions on submitting comments, go to I.B of the SUPPLEMENTARY INFORMATION section of this document. *Docket:* All documents in the docket are listed in the *http://www.regulations.gov index* . Although listed in the index, some information is not publicly available, e.g., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, will be publicly available only in hard copy. Publicly available docket materials are available either electronically in *http://www.regulations.gov* or in hard copy in the Ground Water Program, EPA Region 8, 1595 Wynkoop Street, Denver, CO 80202-1129. This Docket Facility is open Monday through Friday, between 8 a.m. and 4 p.m., excluding legal holidays. The Docket telephone number is 303-312-6079. FOR FURTHER INFORMATION CONTACT: Douglas Minter, U.S. Environmental Protection Agency, 8P-W-GW, 1595 Wynkoop Street, Denver, CO 80202-1129. Phone number: 303-312-6079. E-mail address: *minter.douglas@epa.gov* SUPPLEMENTARY INFORMATION: I. General Information A. Regulated Entities Category Examples of potentially regulated entities North American Industry Classification System State, Local, and Tribal Governments State, local, and Tribal governments that own and operate Class II injection wells within the boundaries of the Fort Peck Indian Reservation 924110 Industry Private owners and operators of Class II injection wells within the boundaries of the Fort Peck Indian Reservation 221310 Municipalities Municipal owners and operators of Class II injection wells within the boundaries of the Fort Peck Indian Reservation 924110 This table is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be regulated by this action. This table lists the types of entities that EPA is now aware could potentially be regulated by this action. Other types of entities not listed in the table could also be regulated. If you have questions regarding the applicability of this action to a particular entity, consult the person listed in the preceding FOR FURTHER INFORMATION CONTACT section. B. What Should I Consider as I Prepare My Comments for EPA? 1. Submitting CBI Do not submit this information to EPA through *http://www.regulations.gov* or e-mail. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as CBI and then identify electronically within the disk or CD-ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. 2. Tips for Preparing Your Comments *When submitting comments, remember to:* • Identify the rulemaking by docket number and other identifying information (subject heading, **Federal Register** date and page number). • Follow directions—The agency may ask you to respond to specific questions or organize comments by referencing a Code of Federal Regulations
(CFR)part or section number. • Explain why you agree or disagree, suggest alternatives, and substitute language for your requested changes. • Describe any assumptions and provide any technical information and/or data that you used. • If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced. • Provide specific examples to illustrate your concerns, and suggest alternatives. • Explain your views as clearly as possible, avoiding the use of profanity or personal threats. • Make sure to submit your comments by the comment period deadline identified. II. Introduction The Fort Peck Assiniboine and Sioux Tribes of Montana (the “Fort Peck Tribes”) have applied to EPA under Sections 1422 and 1425 of the Safe Drinking Water Act (“SDWA”), 42 U.S.C. 300h-1 and 300h-4, for approval of the Fort Peck Tribes' program regulating Class II (oil and gas-related) underground injection wells on the Fort Peck Indian Reservation in Montana. Because the Fort Peck Tribes have sought primacy only for the Class II UIC program, EPA proposes to approve their program under SDWA section 1425. EPA's proposal is based on a careful and extensive legal and technical review of the Tribes' application. As a result of this review, EPA has determined that the Fort Peck Tribes meet all requirements of section 1451 of the SDWA, including that the Tribes have demonstrated adequate jurisdictional authority over all Class II injection activities on the Reservation, including those conducted by nonmembers. EPA has also determined that the Tribes' program meets all applicable requirements for approval under SDWA section 1425, and that they are capable of administering an effective UIC Class II program in a manner consistent with the terms and purposes of the SDWA and all applicable regulations. III. Legal Authorities These regulations are being proposed under authority of sections 1422, 1425, 1450 and 1451 of the Safe Drinking Water Act, 42 U.S.C. 300h-1, 300h-4, 300j-9 and 300j-11. A. Requirements for State UIC Programs Section 1421 of the SDWA requires the Administrator of EPA to promulgate minimum requirements for effective State UIC programs to prevent underground injection activities that endanger underground sources of drinking water (“USDWs”). Sections 1422 and 1425 of the SDWA establish requirements for States seeking EPA approval of State UIC programs. For States that seek approval for UIC programs under Section 1422 of the SDWA, EPA has promulgated a regulation setting forth the applicable procedures and substantive requirements. This regulation has been codified in the *Code of Federal Regulations* (40 CFR part 145). It includes requirements for State permitting programs (by reference to certain provisions of 40 CFR parts 124 and 144), compliance evaluation programs, enforcement authority, and information sharing. For States that seek approval under Section 1425 of the SDWA, which provides an alternative set of requirements for Class II programs, EPA has published interim guidance in the **Federal Register** (46 FR 27333-27339, May 19, 1981), describing how States may apply for program approval under Section 1425 and setting forth the criteria EPA will use in approving or disapproving applications under this provision. By demonstrating that its program represents an effective program to prevent endangerment of USDWs and meets the more general statutory requirements of Section 1421(b)(1)(A) through (D), a State may obtain primacy for a Class II UIC program. B. Tribal UIC Programs Section 1451 of the SDWA and 40 CFR 145.52 authorize the Administrator of EPA to treat an Indian Tribe in the same manner as a State for purposes of the UIC program if the Tribe demonstrates that:
(1)It is recognized by the Secretary of the Interior;
(2)it has a governing body carrying out substantial governmental duties and powers over a defined area;
(3)the functions to be exercised by the Tribe are within an area of the Tribal government's jurisdiction; and
(4)the Tribe is reasonably expected to be capable, in the EPA Administrator's judgment, of implementing a program consistent with the terms and purposes of the SDWA and applicable regulations. Under Section 1451 of the SDWA and 40 CFR part 145, Subpart E, EPA is authorized to treat Indian Tribes similarly to States and may approve Tribal UIC programs. Tribes may apply for primacy under either or both Sections 1422 and 1425 of the SDWA, and the references in 40 CFR part 145 and EPA's May 19, 1981 interim guidance to “State” programs are also construed to include eligible “Tribal” programs. (See 40 CFR 145.1(h), which provides that all requirements of parts 124, 144, 145, and 146 that apply to States with UIC primacy also apply to Indian Tribes except where specifically noted.) IV. Fort Peck Tribes' Application On December 18, 1995, the Fort Peck Tribes submitted an initial application for primacy for all Class II wells on all lands within the exterior boundaries of the Fort Peck Indian Reservation (the “Reservation”). On April 22, 1996, EPA determined that the Fort Peck Tribes’ application was complete. On September 12, 1997, EPA published a notice in the **Federal Register** (62 FR 48086-48087) requesting initial comments and scheduling a public hearing on the application. A similar public notice was also published in newspapers in Great Falls, Billings, and Poplar, Montana. A public hearing was held on October 16, 1997, in Poplar, Montana. On February 12, 1998, EPA provided a set of formal comments to the Fort Peck Tribes for incorporation into their application. In response, the Fort Peck Tribes submitted a revised application on July 27, 1999, stating that the Fort Peck Tribal Executive Board had formally adopted underground injection control provisions in the Tribal Code and requesting primacy under both Sections 1422 and 1425 of the SDWA. V. EPA's Proposed Action EPA is proposing to approve the Fort Peck Tribes' Class II UIC program. Under EPA's proposed approval of the Fort Peck Tribes' application, the Fort Peck Tribes would assume primary enforcement authority (except for the authority that EPA would retain to take criminal actions:
(1)Against non-Indians; and
(2)against Indians where the potential fine required is greater than $5,000 or where the penalty would require imprisonment for more than one year, in accordance with 25 U.S.C. 1302) for regulating all Class II injection activities on all lands within the exterior boundaries of the Reservation. EPA's proposed Decision Document in support of EPA's proposed approval is part of the public record and is now available for public review and comment. The proposed Decision Document includes findings that the Fort Peck Tribes meet all requirements of section 1451 of the SDWA, including that the Tribes have demonstrated adequate jurisdictional authority over all Class II injection activities on the Reservation, including those conducted by nonmembers, and that the Fort Peck Tribes' program meets all applicable requirements for approval under section 1425 of the SDWA. If approved as proposed, the Fort Peck Tribes would administer and enforce their Class II program with respect to all Class II injection wells on the Reservation. Upon approving the Fort Peck Tribes' Class II program, EPA would amend 40 CFR part 147 as proposed in this notice to revise the reference to the EPA-administered program for Class II injection wells on the Reservation to refer to the Fort Peck Tribes' Class II program. EPA would continue to administer its UIC program for Class I, III, IV, and V wells on the Reservation. (Although the Tribal Code prohibits injection in Class I, III, and IV wells, these prohibitions are separate from the Class II program that EPA proposes to approve in this action.) As noted above, EPA would also retain Class II-related criminal enforcement authority against non-Indians on the Reservation, and against Indians on the Reservation where the potential fine required is greater than $5,000 or where the penalty would require imprisonment for more than one year. EPA would oversee the Fort Peck Tribes' administration of the Class II program on the Reservation. Part of EPA's oversight responsibility would include requiring quarterly reports of non-compliance and annual UIC program performance reports pursuant to 40 CFR 144.8. The Memorandum of Agreement between EPA and the Fort Peck Tribes would require, among other things, that EPA review all permits associated with aquifer exemptions not previously approved by EPA. The provisions of the Tribal Code that contain standards, requirements, and procedures applicable to owners or operators of Class II wells on the Reservation would be incorporated by reference into 40 CFR part 147. Any provisions incorporated by reference, as well as all Tribal permit conditions or permit denials issued pursuant to such provisions, would be enforceable by EPA pursuant to section 1423 of the SDWA and 40 CFR 147.1(e). Although the Program Description submitted with the Fort Peck Tribes' application indicates that the Fort Peck Tribes requested an aquifer exemption for the Dakota Sand formation, the Fort Peck Tribes have decided not to pursue this exemption at this time. VI. Public Comments Received to Date In connection with the public comment period and hearing that the Fort Peck Tribes held on September 20, 1995, members of the public asked questions about or commented on several aspects of the proposed Tribal program. The Fort Peck Tribes' written and verbal answers to these questions and comments are given in detail in the Fort Peck Tribes' application, which, along with the other contents of the application and related documentation, are available for public review as described in this proposed rule. The general areas of the comments and summaries of the Fort Peck Tribes' answers are presented briefly below. EPA concurs with the answers that the Fort Peck Tribes have provided. In addition, during EPA's 1997 public comment period on the Fort Peck Tribes' complete application, EPA received comments on the Fort Peck Tribes' proposed program, which are incorporated below. A. Transition From EPA to Tribal Permits Well operators asked various questions about how the Tribal permit program would be administered. In response to questions about Tribal re-permitting for existing wells, the Fort Peck Tribes stated that all EPA-issued permits remain in full effect and Tribal permits will be issued upon review of the EPA permit. The Fort Peck Tribes will charge a fee of $200 per year per well. If the Fort Peck Tribes deny an application for a permit, permit renewal, or permit modification, operators would not be able to obtain permits, permit renewals, or permit modifications from EPA. The Tribal program will apply on all land within the exterior boundaries of the Reservation, including land owned in fee by non-members. B. Requirement To Obtain a Permit An operator recommended that some wells should be authorized by rule to operate until a permit application is either granted or denied. The Fort Peck Tribes replied that they would not change their regulation or the need to obtain a permit before operating wells. EPA takes the position that States and Tribes are free to promulgate requirements more stringent than the minimum Federal requirements for UIC primacy, and the SDWA does not prevent the Fort Peck Tribes from requiring permits for all wells. C. Reporting Requirements Some commenters suggested reducing the reporting requirements by, for example, eliminating the requirement to notify the Fort Peck Tribes within 24 hours of any well workover, suggesting alternative notification requirements, eliminating the monthly reporting requirement, and using monthly rather than daily data. The Fort Peck Tribes elected to retain their reporting requirements, stating, for example, that daily monitoring would reduce the potential to endanger underground sources of drinking water and that monthly reporting makes compliance easier to achieve. A comment addressed to EPA stated that the Fort Peck Tribes' proposed requirement for monthly and annual injection fluid reports may be too stringent, recommending quarterly reporting instead. In response, EPA notes that section 302(b)(11) of the Tribal Code incorporates the requirements of 40 CFR 144.51, 144.54 and 146.23(b) for reporting and monitoring, with certain additional monitoring requirements, which EPA finds to be reasonable in helping ensure that USDWs are being protected. EPA has determined more frequent monitoring and reporting improves the operator's and the Tribes' ability to promptly identify problems and reduce the potential for violations. D. Operating Requirements A commenter questioned the need for the requirement to maintain pressure gauges on the tubing and annulus. The Fort Peck Tribes responded that pressure gauges allowed for agency field inspectors to observe instantaneous wellhead pressures, that several operators on the Reservation already had such pressure gauges, and that this requirement had been developed from protocols used by the State of North Dakota. E. Financial Responsibility Requirements A commenter suggested that a company's size and financial stability should be considered in deciding what type of mechanism, if any, to require for demonstrating financial integrity. The Fort Peck Tribes responded that requiring a surety bond is an easy way to enforce financial responsibility, and that a financially sound company should have no difficulty securing one. The Tribes also responded that part of a company's capability to maintain and operate an injection well safely is demonstrated in securing a surety bond. EPA has determined that requiring a surety bond prior to well operation is reasonable since it eliminates the need to require annual financial statements from a company. Review of annual financial statements creates an ongoing compliance monitoring workload and creates the potential for associated violations for failure to submit such documentation. F. Mechanical Integrity Requirements Two commenters suggested that mechanical integrity tests should be run at pressures no higher than 500 psi (according to one commenter) or 1,000 psi (according to another commenter), instead of up to the “maximum permitted injection pressure.” In response, the Fort Peck Tribes said that they would require mechanical integrity tests to be run at the higher of:
(1)300 psi above the average operational injection pressure; or
(2)the highest operational injection pressure recorded during the past year. The Tribes also stated that the testing pressure required would never be higher than the “maximum permitted injection pressure.” The Tribes recognized that a “maximum permitted injection pressure” much higher than actual operating pressures can be requested by operators in order to avoid the need for subsequent permit modifications. EPA has determined the Tribes' requirement will help ensure that mechanical integrity is maintained up to the “maximum permitted injection pressure,” and that operators should keep this requirement in mind when requesting such pressure limits in their permits. A commenter suggested requiring cement bond logs only in special cases. The Fort Peck Tribes replied that this was an important tool in determining external mechanical integrity and indicated that some States require cement bond logs as a demonstration of mechanical integrity. G. Conflict of Interest Some commenters were concerned that the Fort Peck Tribes would not only regulate injection wells themselves but also own or operate them. They made various suggestions to avoid what they perceived as a conflict, such as having the State of Montana regulate all Class II wells in Montana, including those on the Reservation, having EPA rather than the Tribal court handle appeals for non-Indian operators, and having some mediation process for disputes between the Fort Peck Tribes and permittees. In response, the Fort Peck Tribes explained that the Tribal Office of Environmental Protection, which would administer and enforce the Fort Peck Tribes' regulatory Class II program, is a regulatory body within the Tribal government separate from the entities within the Fort Peck Tribes that own or operate injection wells. The Tribal program would be no different from a State UIC program in which one State department regulates injection activities but another State department maintains mineral holdings. In addition, the Fort Peck Tribes indicated that all surface and royalty agreements relating to mineral leasing and development on the Reservation are required to be approved by the Bureau of Indian Affairs after negotiation by the Fort Peck Tribes. In this sense, the Tribal program would be no different from an approved State UIC program in which appeals would be heard in State court. The Fort Peck Tribes also cited legal authority in support of their civil jurisdiction over non-Indians on Reservation land, concluding that providing appeals to be heard by a Federal Agency instead of the Tribal courts would be inconsistent with the Fort Peck Tribes' governmental authority. H. Permitting Fee Some comments addressed to EPA questioned the annual $200 permitting fees. In response, EPA notes that this fee is intended to help the Fort Peck Tribes cover a portion of the anticipated expense associated with administering their Class II UIC program. The Fort Peck Tribes have estimated annual implementation costs of approximately $55,000, which is considerably more than the amount likely covered by EPA's UIC grant funds to the Tribes. Other UIC programs, such as the program administered by the Montana Board of Oil and Gas Conservation, impose a similar fee on Class II well operators. Although the Fort Peck Tribes expect that the present injection well fee will help cover program administration costs, they will retain the flexibility to raise or lower this fee if appropriate. VII. Other Changes to UIC Regulations This proposed rule includes some minor revisions to 40 CFR 147.1 that are not specific to the Fort Peck Tribes. As a convenience to the reader, EPA has included the full text of 40 CFR 147.1 in this proposal. However, this proposal solicits comments only on the specific amendments proposed, which are:
(1)To revise 40 CFR 147.1 to include specific references to Tribal programs in light of the fact that EPA is proposing in this notice to approve its first Tribal UIC program; and
(2)to reserve 40 CFR 147.1(f), because it duplicates 40 CFR 9.1. It is important and necessary that EPA's regulations codifying approved UIC programs account for the fact that such programs may be run by Tribes. VIII. Generalized Findings As described earlier, EPA's proposed decision to approve the Fort Peck Tribes to implement a Class II UIC program includes findings that the Tribes meet all requirements of section 1451 of the SDWA, including that the Tribes have demonstrated adequate jurisdictional authority over all Class II injection activities on the Reservation, including those conducted by nonmembers. With regard to authority over nonmember activities on nonmember-owned fee lands, EPA is proposing to find that the Tribes have demonstrated such authority under the test established by the United States Supreme Court in *Montana* v. *United States,* 450 U.S. 544
(1981)( *Montana* test). Under the Montana test, the Supreme Court held that absent a Federal grant of authority, Tribes generally lack inherent jurisdiction over the activities of nonmembers on nonmember-owned fee lands. However, the Court also found that Indian Tribes retain inherent sovereign power to exercise civil jurisdiction over nonmember activities on nonmember-owned fee lands within the reservation where:
(1)Nonmembers enter into “consensual relationships with the Tribe or its members, through commercial dealing, contracts, leases, or other arrangements” or
(2)“* * * [nonmember] conduct threatens or has some direct effect on the political integrity, the economic security or the health or welfare of the Tribe.” *Id.* at 565-66. In analyzing Tribal assertions of inherent authority over nonmember activities on Indian reservations, the Supreme Court has reiterated that the *Montana* test remains the relevant standard. See e.g., *Strate* v. *A-1 Contractors* , 520 U.S. 438, 445
(1997)(describing *Montana* as “the pathmarking case concerning Tribal civil authority over nonmembers”); *Nevada* v. *Hicks,* 533 U.S. 353, 358
(2001)(“Indian Tribes” regulatory authority over nonmembers is governed by the principles set forth in [ *Montana* ]”). As part of the public record available for review and comment, EPA's proposed Decision Document, and Appendix A thereto, sets forth the Agency's specific factual findings relating to the Tribes' demonstration of inherent authority over the UIC Class II activities of nonmembers under the *Montana* test and, in particular, the potential for direct effects of nonmember UIC activities on the Tribes' health, welfare, political integrity, and economic security. In addition, EPA is proposing the general findings set forth below regarding the effects of underground injection activities. These general findings provide a foundation for EPA's analysis of the Tribes' assertion of authority under the *Montana* test and, in effect, supplement the Agency's factual findings specific to the Tribes and to the Fort Peck Reservation. A. General Finding on Political, Economic and Human Health and Welfare Impacts In enacting part C of the SDWA, Congress generally recognized that if left unregulated or improperly managed, underground injection wells have the potential to cause serious and substantial, harmful impacts on political and economic interests and human health and welfare. Specifically, as stated in legislative history of the SDWA: [U]nderground injection of contaminants is clearly an increasing problem. Municipalities are increasingly engaging in underground injection of sewage, sludge, and other wastes. Industries are injecting chemicals, byproducts, and wastes. Energy production companies are using injection techniques to increase production and to dispose of unwanted brines brought to the surface during production. Even government agencies, including the military, are getting rid of difficult to manage waste problems by underground disposal methods. Part C is intended to deal with all of the foregoing situations insofar as they may endanger underground sources of drinking water (USDWs). 1 1 *See* H.R. Report No. 93-1185, 93rd Congress, 2nd Session (1974), *reprinted in* “A Legislative History of the Safe Drinking Water Act,” February, 1982, by the Government Printing Office, Serial No. 97-9, page 561. In response to the problem of the substantial risks inherent in underground injection activities, Congress enacted section 1421 of the SDWA “ to assure that drinking water sources, actual and potential, are not rendered unfit for such use by underground injection of contaminants.” 2 2 Ibid., page 560. In enacting part C of the SDWA, Congress more specifically found that mismanaged underground injection activities could have serious and substantial, harmful impacts on the public's economic and political interests, as well as its health and welfare. For example, Congress found that: Federal air and water pollution control legislation have increased the pressure to dispose of waste materials on or below land, frequently in ways, such as subsurface injection, which endanger drinking water quality. Moreover, the national economy may be expected to be harmed by unhealthy drinking water and the illnesses which may result therefrom. 3 3 Ibid., page 540. Congress specifically noted several economic and political consequences that can result from the degradation of good quality drinking water supplies, including:
(1)Inhibition of interstate tourism and travel;
(2)loss of economic productivity because of absence from employment due to illness;
(3)limited ability of a town or region to attract workers; and
(4)impaired economic growth of a town or region, and, ultimately, the nation. 4 4 Ibid., page 540. As the Agency charged by Congress with implementing part C of the SDWA and assuring implementation of effective UIC programs throughout the United States, EPA agrees with these Congressional findings. EPA finds that underground injection activities, if not effectively regulated, can have serious and substantial, harmful impacts on human health, welfare, economic, and political interests. In making this finding, EPA recognizes that:
(1)The underground injection activities, currently regulated as five distinct classes of injection wells as defined in the UIC regulations, typically emplace a variety of potentially harmful organic and inorganic contaminants (e.g., brines and hazardous wastes) into the ground;
(2)these injected contaminants have the potential to enter USDWs through a variety of migratory pathways if injection wells are not properly managed; and
(3)once present in USDWs, these injected contaminants can have harmful impacts on human health and welfare, and political and economic interests, that are both serious and substantial. In 1980, EPA issued a document entitled, “Underground Injection Control Regulations: Statement of Basis and Purpose,” which provides the rationale for the Agency in proposing specific regulatory controls for a variety of underground injection activities. These controls, or technical requirements (e.g., testing to ensure the mechanical integrity of an injection well), were promulgated to prevent release of pollutants through the six primary “pathways of contamination,” or well-established and recognized “ways in which fluids can escape the well or injection horizon and enter USDWs.” 5 EPA has found that USDW contamination from one or more of these pathways can occur from underground injection activity of all classes (I-V) of injection wells. 5 “Underground Injection Control Regulations: Statement of Basis and Purpose,” EPA (May, 1980), page 7. *The six pathways are:* 1. Migration of fluids through a leak in the casing of an injection well and directly into a USDW; 2. Vertical migration of fluids through improperly abandoned and improperly completed wells in the vicinity of injection well operations; 3. Direct injection of fluids into or above a USDW; 4. Upward migration of fluids through the annulus, which is the space located between the injection well's casing and the well bore. This can occur if there is sufficient injection pressure to push such fluid into an overlying USDW; 5. Migration of fluids from an injection zone through the confining strata over or underlying a USDW. This can occur if there is sufficient injection pressure to push fluid through a stratum, which is either fractured or permeable, and into the adjacent USDW; and 6. Lateral migration of fluids from within an injection zone into a portion of that stratum considered to be a USDW. In this scenario, there may be no impermeable layer or other barrier to prevent migration of such fluids. 6 6 “Underground Injection Control Regulations: Statement of Basis and Purpose,” EPA, (May, 1980), pp. 7-17. Moreover, consistent with EPA's findings, the U.S. Department of the Interior has recognized the ability of injection wells to contaminate surface waters that are hydrogeologically connected to contaminated ground water. 7 Such contamination of surface waters could further cause negative impacts on human health and welfare, and economic and political interests. 7 *See* Federal Water Quality Administration's Order COM 5040.10 (1970), *as referred to in* H.R. Report No. 93-1185, 561. In sum, EPA finds that, given the common presence of contaminants in injected fluids, serious and substantial contamination of ground water and surface water resources can result from improperly regulated underground injection activities. Moreover, such contamination has the potential to cause correspondingly serious and substantial harm to human health and welfare, and political and economic interests. EPA also has determined that Congress reached a similar finding when it enacted part C of the SDWA, directing EPA to establish UIC programs to mitigate and prevent such harm through the proper regulation of underground injection activities. B. General Finding on the Necessity of Protecting Safe Drinking Water Supplies as a Necessary Incidence of Self-Government Consistent with the finding that improperly managed underground injection activities can have direct harmful effects on human health and welfare, and economic and political interests that are serious and substantial, EPA has determined that proper management of such activities serves the purpose of protecting these public health and welfare, and political and economic interests, which is a core governmental function whose exercise is integral to, and a necessary aspect of, self-government. *See* 56 FR 64876, 64879 (December 12, 1991); *Montana* v. *EPA,* 137 F.3d 1135, 1140-41 (9th Cir. 1998). EPA has determined that Congress reached this conclusion in enacting the SDWA and that Congress considered enactment of the SDWA to be a necessary act of self-government, serving to protect essential and vital public interests by ensuring that the public's essential drinking water supplies are safe from contamination, including contamination caused by underground injection activities. The above findings regarding the effects on public health and welfare, and economic and political interests are generally true for human beings and their communities, wherever they may be located. EPA has determined that the above findings that underground injection regulation is an integral and necessary incident of self-government is generally true for any Federal, State and/or Tribal government having responsibility for protecting public health and welfare. With specific relevance to Tribes, EPA has long noted the relationship between proper environmental management within Indian country and Tribal self-government and self-sufficiency. Moreover, in the 1984 *EPA Policy for the Administration of Environmental Programs on Indian Reservations,* EPA determined that as part of the “principle of Indian self-government,” Tribal governments are the “appropriate non-Federal parties for making decisions and carrying out program responsibilities affecting Indian reservations, their environments, and the health and welfare of the reservation populace,” consistent with Agency standards and regulations. ( *EPA Policy for the Administration of Environmental Programs on Indian Reservations,* Paragraph 2, November 8, 1984). EPA interprets section 1451 of the SDWA, in providing for the approval of Tribal programs under the Act, as authorizing eligible Tribes to assume a primary role in protecting drinking water sources. These general findings provide a backdrop for EPA's legal analysis of the Fort Peck Tribes' Application and, in effect, supplement EPA's factual findings specific to the Fort Peck Tribes and to the Fort Peck Reservation, contained in the proposed Decision Document and Appendix A thereto, and the Fort Peck Tribes' similar conclusions, contained in their Application, pertaining specifically to the Fort Peck Tribes and the Fort Peck Reservation. IX. Statutory and Executive Order Reviews A. Executive Order 12866: Regulatory Planning and Review This action is not a “significant regulatory action” under the terms of Executive Order 12866 (58 FR 51735, October 4, 1993) and is therefore not subject to review under the EO. The Class II injection wells the Tribes propose to regulate are currently subject to EPA's regulatory program as described in 40 CFR part 147, subpart BB. Additionally, the Tribes' proposed program is, in many respects, identical to, and in some respects, more stringent than, EPA's program. B. Paperwork Reduction Act This action does not impose an information collection burden under the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 *et seq.* EPA has determined that there is no need for an Information Collection Request under the Paperwork Reduction Act because this proposed rule would not impose any new Federal reporting or record-keeping requirements. Reporting or record-keeping requirements would be based on the Tribal Code, and the Fort Peck Tribes are not subject to the Paperwork Reduction Act. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal Agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information. An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations in 40 CFR are listed in 40 CFR part 9. C. Regulatory Flexibility Act The Regulatory Flexibility Act
(RFA)generally requires an agency to prepare a regulatory flexibility analysis of any rule subject to notice and comment rulemaking requirements under the Administrative Procedure Act or any other statute unless the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. Small entities include small businesses, small organizations, and small governmental jurisdictions. For purposes of assessing the impacts of this proposed rule on small entities, small entity is defined as:
(1)A small business that is primarily engaged in crude petroleum and natural gas extraction as defined by NAICS Code 211111 according to Small Business Administration size standards for entities employing fewer than 500 employees;
(2)a small governmental jurisdiction that is a government of a city, county, town, school district or special district with a population of less than 50,000; and
(3)a small organization that is any not-for-profit enterprise which is independently owned and operated and is not dominant in its field. After considering the economic impacts of this proposed rule on small entities, I certify that this action will not have a significant economic impact on a substantial number of small entities. The small entities directly regulated by this proposed rule are owners or operators of Class II wells, employing fewer than 500 employees. We have determined that less than 7 small entities will experience an impact of greater than 1% of annual revenues. These entities would be subject to requirements substantially similar to the existing requirements of EPA's program under 40 CFR 147.1351(a) and would not incur significant new costs as a result of this proposed rule. For example, the Tribes propose to charge an annual $200 permitting fee for each Class II well on the Reservation. While this will impose a new cost on a small entity, this cost will not have a significant economic impact on a substantial number of small entities due to the few small entities owning/operating the 23 Class II wells on the Reservation. Moreover, in approving State UIC programs imposing similar fees on a greater number of small entities, EPA determined that these new costs did not have a significant economic impact on a substantial number of small entities. Although this proposed rule will not have a significant economic impact on a substantial number of small entities, EPA nonetheless has tried to reduce the impact of this rule on small entities. The Fort Peck Tribes' program is more stringent than the existing Federal program in certain respects. For example, unlike the existing Federal program, the Fort Peck Tribes' program requires permits for all Class II wells, with no provision for authorization by rule. (See section 202(c) of the Tribal Code.) However, because all Class II wells now in operation on the Reservation currently hold EPA permits, this more stringent requirement will not impose a significant economic impact on the owners or operators of these wells. Other requirements in the Fort Peck Tribes' program that are more stringent than the existing Federal program are identified in the proposed Decision Document available for public review and comment and are mostly minor observation, recording, and reporting requirements. These requirements also will not impose a significant economic effect on the owners or operators of these wells. We continue to be interested in any potential impacts of the proposed rule on small entities and welcome comments on issues related to any such impacts. D. Unfunded Mandates Reform Act Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Pub. L. 104-4, establishes requirements for Federal Agencies to assess the effects of their regulatory actions on State, local, and Tribal governments and the private sector. Under section 202 of the UMRA, EPA generally must prepare a written statement, including a cost-benefit analysis, for proposed and final rules with “Federal mandates” that may result in expenditures to State, local, and Tribal governments, in the aggregate, or to the private sector, of $100 million or more in any one year. Before promulgating an EPA rule for which a written statement is needed, section 205 of the UMRA generally requires EPA to identify and consider a reasonable number of regulatory alternatives and adopt the least costly, most cost-effective or least burdensome alternative that achieves the objectives of the rule. The provisions of section 205 do not apply when they are inconsistent with applicable law. Moreover, section 205 allows EPA to adopt an alternative other than the least costly, most cost-effective or least burdensome alternative if the Administrator publishes with the final rule an explanation why that alternative was not adopted. Before EPA establishes any regulatory requirements that may significantly or uniquely affect small governments, including Tribal governments, it must have developed under section 203 of the UMRA, a small government agency plan. The plan must provide for notifying potentially affected small governments, enabling officials of affected small governments to have meaningful and timely input in the development of EPA regulatory proposals with significant Federal intergovernmental mandates, and informing, educating, and advising small governments on compliance with the regulatory requirements. This proposed rule contains no Federal mandates (under the regulatory provisions of Title II of the UMRA) for State, local, or Tribal governments or the private sector because the rule imposes no enforceable duty on any State, local, or Tribal governments or the private sector. EPA's proposed approval of the Fort Peck Tribes' program would not constitute a “Federal mandate” because there is no requirement that Tribes establish UIC regulatory programs and because the program, if finally approved, will be a Tribal, rather than a Federal program. Thus, this proposed rule is not subject to the requirements of sections 202 and 205 of the UMRA. For the same reason, EPA has determined that this proposed rule contains no regulatory requirements that might significantly or uniquely affect small governments. Thus, this proposed rule is not subject to the requirements of section 203 of the UMRA. E. Executive Order 13132—Federalism Executive Order 13132, entitled “Federalism”(64 FR 43255, August 10, 1999), requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive Order to include regulations that have “substantial direct effects on States, on the relationship between the national government and States, or on the distribution of power and responsibilities among the various levels of government.” This proposed rule does not have federalism implications. It will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132. If finalized, the proposed rule would merely put in place a Tribal regulatory program that is identical in many respects to the existing federal program and more stringent in certain respects, as explained in more detail in the proposed Decision Document. EPA will continue to administer its Class I, III, IV, and V UIC programs on the Reservation. Authorizing the Fort Peck Tribes to administer the Class II program will not substantially alter the distribution of power and responsibilities among levels of government or significantly change EPA's relationship with Montana. The substitution of a Tribal Class II program in place of an EPA-administered Class II program on the Fort Peck Reservation will impose no additional costs on the State of Montana. Thus, Executive Order 13132 does not apply to this rule. In the spirit of Executive Order 13132, EPA specifically solicits comment on this proposed rule from State and local officials. F. Executive Order 13175—Consultation and Coordination With Indian Tribal Governments Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000), requires EPA to develop an accountable process to ensure “meaningful and timely input by Tribal officials in the development of regulatory policies that have Tribal implications.” EPA has concluded that this proposed rule will have Tribal implications. However, it will neither impose substantial direct compliance costs on Tribal governments, nor preempt Tribal law. The Fort Peck Tribes have voluntarily requested EPA authorization to administer their own Class II UIC program and have voluntarily assumed the Tribal share of the costs for doing so. Additionally, EPA is proposing to approve the Tribes' application for UIC Class II primacy and thus replace the existing Federal UIC Class II program for the Fort Peck Indian Reservation with a Tribal program administered pursuant to the laws of the Fort Peck Tribes. Thus, the requirements of sections 5(b) and 5(c) of the Executive Order do not apply to this proposed rule. EPA consulted with Tribal officials early in the process of developing this regulation to permit them to have meaningful and timely input into its development. (See section IV, V, and VI for more information.) In the spirit of Executive Order 13175, EPA specifically solicits additional comment on this proposed rule from Tribal officials. G. Executive Order 13045: Protection of Children From Environmental Health & Safety Risks *Executive Order 13045:* “Protection of Children from Environmental Health Risks & Safety Risks” (62 FR 19885, April 23, 1997) applies to any rule that:
(1)Is determined to be economically significant as defined under Executive Order 12866, and
(2)concerns an environmental health or safety risk that EPA has reason to believe may have a disproportionate effect on children. If the regulatory action meets both criteria, the Agency must evaluate the environmental health or safety effects of the planned rule on children, and explain why the planned regulation is preferable to other potentially effective and reasonably feasible alternatives considered by the Agency. This proposed rule is not subject to Executive Order 13045 because it is not economically significant as defined in Executive Order 12866, and because the Agency does not have reason to believe the environmental health or safety risks addressed by this action present a disproportionate risk to children. The proposed Fort Peck Tribes' Class II UIC program is more stringent than the existing federal program; the Tribal program requirements have been established to prevent underground injection activities that endanger underground sources of drinking water (USDWs). The Fort Peck Tribal Executive Board has formally adopted underground injection control provisions in the Tribal Code in their program to safeguard these resources for all potential users, including but not limited to children. H. Executive Order 13211: Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use This proposed rule is not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355 (May 22, 2001)) because it is not a significant regulatory action under Executive Order 12866. I. National Technology Transfer and Advancement Act Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (“NTTAA”), Public Law No. 104-113, 12(d) (15 U.S.C. 272 note), directs EPA to use voluntary consensus standards in its regulatory activities unless to do so would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (e.g., materials specifications, test methods, sampling procedures, and business practices) that are developed or adopted by voluntary consensus standards bodies. The NTTAA directs EPA to provide Congress, through OMB, explanations when the Agency decides not to use available and applicable voluntary consensus standards. This proposed rulemaking does not involve technical standards. Therefore, EPA is not considering the use of any voluntary consensus standards. J. Executive Order 12898: Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations Executive Order
(EO)12898 (59 FR 7629 (Feb. 16, 1994)) establishes federal executive policy on environmental justice. Its main provision directs federal agencies, to the greatest extent practicable and permitted by law, to make environmental justice part of their mission by identifying and addressing, as appropriate, disproportionately high and adverse human health or environmental effects of their programs, policies, and activities on minority populations and low-income populations in the United States. EPA has determined that this proposed rule will not have disproportionately high and adverse human health or environmental effects on minority or low-income populations because it does not decrease the level of protection provided to human health or the environment or lessen current environmental standards. If finalized, this proposed rule would put in place a Tribal regulatory program that is more stringent than the federal program and, therefore, would increase the level of protection. For example, unlike the existing federal program, the Fort Peck Tribes' program requires permits for all Class II wells, with no provision for authorization by rule. Moreover, in proposing to approve the Tribes' own Class II program, EPA is enhancing the Tribes' ability to determine its own UIC affairs on its Reservation. List of Subjects in 40 CFR Part 147 Environmental protection, Indian-lands, Intergovernmental relations, Reporting and recordkeeping requirements, Water supply, Incorporation by reference. Dated: November 16, 2007. Robert E. Roberts, Regional Administrator, U.S. EPA Region 8. For the reasons set out in the preamble, chapter I of title 40 of the Code of Federal Regulations is proposed to be amended as follows: PART 147—STATE, TRIBAL, AND EPA-ADMINISTERED UNDERGROUND INJECTION CONTROL PROGRAMS 1. The authority citation for part 147 is revised to read as follows: Authority: 42 U.S.C. 300h *et seq.* ; and 42 U.S.C. 6901 *et seq.* 2. Part 147 heading is revised as set forth above. Subpart A—[Amended] 3. Section 147.1 is revised to read as follows: § 147.1 Purpose and scope.
(a)This part sets forth the applicable Underground Injection Control
(UIC)programs for each of the States, territories, and possessions identified pursuant to the Safe Drinking Water Act
(SDWA)as needing a UIC program, including any Indian country geographically located within those States, territories, and possessions.
(b)The applicable UIC programs set forth in this part may be State-administered programs approved by EPA, Tribally-administered programs approved by EPA, or Federally-administered programs promulgated by EPA. In some cases, the applicable UIC program for a particular area may consist of a State-administered or Tribally-administered program applicable to some classes of wells and a Federally-administered program applicable to other classes of wells. Approval of a State or Tribal program is based upon a determination by the Administrator that the program meets the requirements of section 1422 or section 1425 of the SDWA, any other applicable provisions of this subpart, and the applicable provisions of 40 CFR parts 124, 144, 145 and 146. A Federally-administered program is promulgated in those instances where the State or Tribe has not submitted any program for approval or where the submitted program does not meet the minimum Federal statutory and regulatory requirements.
(c)In the case of each State or Tribal program approved by EPA pursuant to section 1422 of the SDWA, the relevant subpart describes the major elements of that program, including the relevant State or Tribal statutes and regulations, the Statement(s) of Legal Authority, the Memorandum of Agreement, and the Program Description. State or Tribal statutes and regulations that contain standards, requirements, and procedures applicable to owners or operators have been incorporated by reference pursuant to regulations of the Office of the Federal Register. Material incorporated by reference is available for inspection in the appropriate EPA Regional office, in EPA Headquarters, and at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call
(202)741-6030, or go to: *http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html* . Other State or Tribal statutes and regulations containing standards and procedures that constitute elements of a State or Tribal program but do not apply directly to owners or operators have been listed but have not been incorporated by reference.
(d)In the case of any program promulgated under section 1422 for a State or Tribe that is to be administered by EPA, the relevant State or Tribal subpart makes applicable the provisions of 40 CFR parts 124, 144, 146, and 148, and any other additional requirements pertinent to the specific State or Tribal program.
(e)Regulatory provisions incorporated by reference (in the case of approved State or Tribal programs) or promulgated by EPA (in the case of EPA-administered programs), and all permit conditions or permit denials issued pursuant to such regulations, are enforceable by the Administrator pursuant to section 1423 of the SDWA.
(f)[Reserved]. Subpart BB—[Amended] 4. Section 147.1351 is amended by revising the first sentence of paragraph
(a)and by revising paragraph
(b)to read as follows: § 147.1351 EPA-administered program.
(a)*Contents.* The UIC program in the State of Montana for Class I, III, IV, and V wells, and for all Classes of wells in Indian country in Montana, except for Class II wells on all lands within the exterior boundaries of the Fort Peck Indian Reservation, is administered by EPA. * * *
(b)*Effective dates.* The effective date for the UIC program for Class I, III, IV, and V wells for all lands in Montana, including all Indian country in Montana, and for Class II wells for all Indian country in Montana other than the Fort Peck Indian Reservation, is June 25, 1984. The effective date for the EPA-approved State-administered UIC Class II program for all lands in Montana, except for those in Indian country, is provided in § 147.1350. 5. Subpart JJJ is added to read as follows: Subpart JJJ—Assiniboine and Sioux Tribes § 147.3200 Fort Peck Indian Reservation: Assiniboine & Sioux Tribes—Class II wells. The UIC program for Class II injection wells on all lands within the exterior boundaries of the Fort Peck Indian Reservation is the program administered by the Assiniboine and Sioux (Fort Peck) Tribes approved by EPA pursuant to section 1425 of the SDWA. Notice of this approval was published in the **Federal Register** on [DATE OF FINAL RULE PUBLICATION]; the effective date of this program is [ *DATE OF FINAL RULE PUBLICATION* ]. This program consists of the following elements as submitted to EPA in the Fort Peck Tribes' program application:
(a)*Incorporation by Reference.* The requirements set forth in the Fort Peck Tribes' statutes, regulations, and resolutions cited in this paragraph are hereby incorporated by reference and made part of the applicable UIC program under the SDWA for the Fort Peck Indian Reservation. 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. Copies may be obtained or inspected at the Fort Peck Tribal Offices, 605 Indian Avenue, Poplar, Montana 59255, at the Environmental Protection Agency, Region 8, 1595 Wynkoop Street, Denver, Colorado 80202-1129, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call
(202)741-6030, or go to: *http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html* .
(1)*Tribal Code.* Provisions of the Tribal Code listed in Appendix A to this Subpart.
(2)Tribal Government Resolution No. 1106-92-6.
(b)*Memorandum of Agreement (MOA)* . The MOA between EPA and the Fort Peck Tribes signed by EPA on July 31, 2007.
(c)*Statements of legal authority.* Letters to EPA from Sonosky, Chambers, Sachse, Endreson & Perry, dated September 4, 2003 (attaching a June 17, 2002 letter), March 27, 2001, July 19, 1999, March 13, 1995, March 16, 1994, November 4, 1992, July 14, 1989, and April 13, 1989, and letters submitted as part of the Fort Peck Tribes' application.
(d)*Program Description.* The Program Description submitted as part of the Fort Peck Tribes' application, and any other materials submitted as part of the application or as a supplement to it. Appendix A to Subpart JJJ of Part 147—Fort Peck Tribal Requirements Incorporated by Reference in Subpart JJJ of Part 147 of the Code of Federal Regulations The following is an informational listing of Fort Peck Tribal requirements incorporated by reference in Subpart JJJ of part 147 of the Code of Federal Regulations: Fort Peck Assiniboine and Sioux Tribes
(a)The statutory provisions include portions of the following insofar as they pertain to Class II injection wells: Fort Peck Assiniboine and Sioux Tribal Underground Injection Control Code, adopted June 1999, Title 18: Chapter 1. General Provisions Section 101. Purposes. Section 102. Administration. Section 103. Regulations, Criteria, and Standards. Section 104. Definitions. Section 105. Application. Chapter 2. General Underground Injection Control Program Requirements Section 201. Introduction. Section 202. Requirements. Chapter 3. Underground Injection Control Permit Requirements Section 301. Introduction. Section 302. Requirements. Chapter 4. UIC Permitting Procedures Section 401. Introduction. Section 402. Requirements. Chapter 5. UIC Technical Criteria and Standards Section 501. Introduction. Section 502. Requirements. Section 503. Additional Requirements. Chapter 6. Enforcement Section 601. Requirements for Compliance Evaluation Programs. Section 602. Administrative Enforcement. Section 603. Administrative Penalties. Section 604. Civil Penalties. Section 605. Criminal Violations. Section 606. Judicial Relief. Section 607. Public Participation in Office of Environmental Protection Enforcement Process. Chapter 7. Appeals Section 701. Judicial Review. Chapter 8. Public Hearings Section 801. Public Hearings. Chapter 9. Miscellaneous Section 901. Savings. Section 902. Effective Date.
(b)The provisions of Tribal Government Resolution Number 1106-92-6, adopted June 22, 1992, insofar as this resolution prohibits injection by Class II wells into the Judith River formation. [FR Doc. E8-1667 Filed 1-29-08; 8:45 am] BILLING CODE 6560-50-P DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency 44 CFR Part 67 [Docket No. FEMA-B-7760] Proposed Flood Elevation Determinations AGENCY: Federal Emergency Management Agency, DHS. ACTION: Proposed rule. SUMMARY: Comments are requested on the proposed Base (1 percent annual-chance) Flood Elevations
(BFEs)and proposed BFE modifications for the communities listed in the table below. The purpose of this notice is to seek general information and comment regarding the proposed regulatory flood elevations for the reach described by the downstream and upstream locations in the table below. The BFEs and modified BFEs are a part of the floodplain management measures that the community is required either to adopt or show evidence of having in effect in order to qualify or remain qualified for participation in the National Flood Insurance Program (NFIP). In addition, these elevations, once finalized, will be used by insurance agents, and others to calculate appropriate flood insurance premium rates for new buildings and the contents in those buildings. DATES: Comments are to be submitted on or before April 29, 2008. ADDRESSES: The corresponding preliminary Flood Insurance Rate Map
(FIRM)for the proposed BFEs for each community are available for inspection at the community's map repository. The respective addresses are listed in the table below. You may submit comments, identified by Docket No. FEMA-B-7760, to William R. Blanton, Jr., Chief, Engineering Management Branch, Mitigation Directorate, Federal Emergency Management Agency, 500 C Street, SW., Washington, DC 20472,
(202)646-3151, or (e-mail) *bill.blanton@dhs.gov* . FOR FURTHER INFORMATION CONTACT: William R. Blanton, Jr., Chief, Engineering Management Branch, Mitigation Directorate, Federal Emergency Management Agency, 500 C Street, SW., Washington, DC 20472,
(202)646-3151, or (e-mail) *bill.blanton@dhs.gov* . SUPPLEMENTARY INFORMATION: The Federal Emergency Management Agency
(FEMA)proposes to make determinations of BFEs and modified BFEs for each community listed below, in accordance with section 110 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4104, and 44 CFR 67.4(a). These proposed BFEs and modified BFEs, together with the floodplain management criteria required by 44 CFR 60.3, are the minimum that are required. They should not be construed to mean that the community must change any existing ordinances that are more stringent in their floodplain management requirements. The community may at any time enact stricter requirements of its own, or pursuant to policies established by other Federal, State, or regional entities. These proposed elevations are used to meet the floodplain management requirements of the NFIP and are also used to calculate the appropriate flood insurance premium rates for new buildings built after these elevations are made final, and for the contents in these buildings. Comments on any aspect of the Flood Insurance Study and FIRM, other than the proposed BFEs, will be considered. A letter acknowledging receipt of any comments will not be sent. *Administrative Procedure Act Statement.* This matter is not a rulemaking governed by the Administrative Procedure Act (APA), 5 U.S.C. 553. FEMA publishes flood elevation determinations for notice and comment; however, they are governed by the Flood Disaster Protection Act of 1973, 42 U.S.C. 4105, and the National Flood Insurance Act of 1968, 42 U.S.C. 4001 *et seq.* , and do not fall under the APA. *National Environmental Policy Act.* This proposed rule is categorically excluded from the requirements of 44 CFR part 10, Environmental Consideration. An environmental impact assessment has not been prepared. *Regulatory Flexibility Act.* As flood elevation determinations are not within the scope of the Regulatory Flexibility Act, 5 U.S.C. 601-612, a regulatory flexibility analysis is not required. *Executive Order 12866, Regulatory Planning and Review.* This proposed rule is not a significant regulatory action under the criteria of section 3(f) of Executive Order 12866, as amended. *Executive Order 13132, Federalism.* This proposed rule involves no policies that have federalism implications under Executive Order 13132. *Executive Order 12988, Civil Justice Reform.* This proposed rule meets the applicable standards of Executive Order 12988. List of Subjects in 44 CFR Part 67 Administrative practice and procedure, Flood insurance, Reporting and recordkeeping requirements. Accordingly, 44 CFR part 67 is proposed to be amended as follows: PART 67—[AMENDED] 1. The authority citation for part 67 continues to read as follows: Authority: 42 U.S.C. 4001 *et seq.* ; Reorganization Plan No. 3 of 1978, 3 CFR, 1978 Comp., p. 329; E.O. 12127, 44 FR 19367, 3 CFR, 1979 Comp., p. 376. § 67.4 [Amended] 2. The tables published under the authority of § 67.4 are proposed to be amended as follows: State City/town/county Source of flooding Location** * Elevation in feet
(NGVD)+ Elevation in feet
(NAVD)# Depth in feet above ground Existing Modified Unincorporated Areas of Sutter County, California California Unincorporated Areas of Sutter County East Side Canal Downstream source of the East Side Canal *38 *40 1500 feet downstream of Catlett Road *39 *40 California Unincorporated Areas of Sutter County King Slough Confluence with East Side Canal *39 *40 1600 feet upstream of the confluence of North King Slough *39 *40 California Unincorporated Areas of Sutter County North King Slough Confluence with King Slough *39 *40 3200 feet upstream of the confluence with King Slough *39 *40 * National Geodetic Vertical Datum. # Depth in feet above ground. + North American Vertical Datum. ** BFEs to be changed include the listed downstream and upstream BFEs, and include BFEs located on the stream reach between the referenced locations above. Please refer to the revised Flood Insurance Rate Map located at the community map repository (see below) for exact locations of all BFEs to be changed. Send comments to William R. Blanton, Jr., Chief, Engineering Management Branch, Mitigation Directorate, Federal Emergency Management Agency, 500 C Street, SW., Washington, DC 20472. ADDRESSES Unincorporated Areas of Sutter County Maps are available for inspection at Sutter County Administrators Office, 1160 Civic Center Boulevard, Yuba City, CA 95993. Flooding source(s) Location of referenced elevation** * Elevation in feet
(NGVD)+ Elevation in feet
(NAVD)# Depth in feet above ground Effective Modified Communities affected Clatsop County, Oregon, and Incorporated Areas Columbia River Approximately at Warrenton-Astoria Alt Highway south of Astoria Regional Airport +9 +12 Unincorporated Areas of Clatsop County, City of Warrenton. Approximately 600 feet upstream of SE Anchor Road, West of Burlington Northern railroad +9 +12 Lewis & Clark River Approximately 1/2 mile downstream of confluence with Heckard Creek, east of Lewis & Clark River +9 +12 Unincorporated Areas of Clatsop County. Approximately at confluence with Heckard Creek, east of Lewis & Clark River +9 +13 Youngs River Approximately 500 feet south of confluence with Battle Creek Slough +7 +12 Unincorporated Areas of Clatsop County. Approximately at intersection of Wireless Road & Hwy 101 Business +9 +12 * National Geodetic Vertical Datum. + North American Vertical Datum. # Depth in feet above ground. ** BFEs to be changed include the listed downstream and upstream BFEs, and include BFEs located on the stream reach between the referenced locations above. Please refer to the revised Flood Insurance Rate Map located at the community map repository (see below) for exact locations of all BFEs to be changed. Send comments to William R. Blanton, Jr., Chief, Engineering Management Branch, Mitigation Directorate, Federal Emergency Management Agency, 500 C Street SW., Washington, DC 20472. ADDRESSES City of Warrenton Maps are available for inspection at 225 South Main Street, Warrenton, OR 97146. Unincorporated Areas of Clatsop County Maps are available for inspection at 800 Exchange Street, Astoria, OR 97103. Perry County, Pennsylvania, and Incorporated Areas Juniata River Approximately 8,820 feet downstream of State Highway 17 (Sunbury Street) None +402 Township of Tuscarora. Approximately 5,420 feet upstream of State Highway 17 (Sunbury Street) None +408 Little Buffalo Creek Approximately 5,200 feet upstream of State Route 4010 None +428 Township of Juniata. Approximately 5,340 feet upstream of State Route 4010 None +428 Losh Run Approximately 410 feet downstream of Conrail Railroad None +369 Township of Miller. Approximately 930 feet upstream of Conrail Railroad None +369 Losh Run Approximately 495 feet downstream of Conrail Railroad None +369 Township of Wheatfield. Approximately 880 feet upstream of Conrail Railroad None +369 Raccoon Creek Approximately 30 feet downstream of Local Route 50024 None +405 Township of Tuscarora. Approximately 1,150 feet upstream of Local Route 50024 None +405 Sugar Run Approximately 605 feet downstream of Hill Road (T-432) None +404 Township of Tuscarora. Approximately 330 feet upstream of Hill Road (T-432) None +404 * National Geodetic Vertical Datum. + North American Vertical Datum. # Depth in feet above ground. ** BFEs to be changed include the listed downstream and upstream BFEs, and include BFEs located on the stream reach between the referenced locations above. Please refer to the revised Flood Insurance Rate Map located at the community map repository (see below) for exact locations of all BFEs to be changed. Send comments to William R. Blanton, Jr., Chief, Engineering Management Branch, Mitigation Directorate, Federal Emergency Management Agency, 500 C Street, SW., Washington, DC 20472. ADDRESSES Township of Juniata Maps are available for inspection at 16 Milford Rd, Newport, PA 17074. Township of Miller Maps are available for inspection at 55410 Limekiln Lane, Duncannon, PA 17020. Township of Tuscarora Maps are available for inspection at 72 Cementery Rd, Millerstown, PA 17062. Township of Wheatfield Maps are available for inspection at Rt. 274, New Bloomfield Road, New Bloomfield, PA 17068. Hanover County, Virginia, and Incorporated Areas Beaverdam Creek Approximately 384 feet downstream of Old State Route 156 *92 *91 Unincorporated Areas of Hanover County. Approximately 6,450 feet upstream of the Woodbridge Road *152 *151 Bull Run Approximately 1,260 feet upstream of the confluence with North Anna River *74 *75 Unincorporated Areas of Hanover County. Approximately 1,344 feet upstream of the confluence with North Anna River *74 *75 Crump Creek At approximately 2,800 feet downstream of River Road None *39 Unincorporated Areas of Hanover County. Approximately at New Britton Road None *191 Lickinghole Creek Approximately 643 feet upstream from the confluence with Stony Run None *126 Unincorporated Areas of Hanover County. Approximately at Design Road None *220 Little River Approximately at State Route 688 (Doswell Road) None *95 Unincorporated Areas of Hanover County. Approximately 7,000 feet upstream from the confluence with Locust Creek None *218 Mechumps Creek Approximately 3,258 feet upstream of Route 301 *51 *50 Town of Ashland, Unincorporated Areas of Hanover County. Approximately at Route 1 None *211 North Anna River Approximately 3.4 miles upstream of Route 1 None *104 Unincorporated Areas of Hanover County. Approximately 3,015 feet upstream from Greek Bay Road None *201 Pamunkey River Approximately 860 feet downstream of the confluence with Whitting Swamp None *11 Unincorporated Areas of Hanover County. Approximately at the confluence with North Anna Creek and South Anna Creek None *60 South Anna Creek Approximately at State Route 54 None *110 Unincorporated Areas of Hanover County. Approximately 10,750 feet upstream of the confluence with Turkey Creek None *214 Stony Run Approximately 50 feet upstream of Route 682 *132 *131 Town of Ashland, Unincorporated Areas of Hanover County. Approximately at Elmont Road None *220 Totopotomoy River Approximately 2,000 feet downstream of the River Road None *28 Unincorporated Areas of Hanover County. Approximately at Sliding Hill Road None *173 Tributary to Beaverdam Creek Approximately 580 feet upstream of the confluence with Beaverdam Creek None *140 Unincorporated Areas of Hanover County. Approximately 1,474 feet upstream of the confluence with Beaverdam Creek None *140 * National Geodetic Vertical Datum. + North American Vertical Datum. # Depth in feet above ground. ** BFEs to be changed include the listed downstream and upstream BFEs, and include BFEs located on the stream reach between the referenced locations above. Please refer to the revised Flood Insurance Rate Map located at the community map repository (see below) for exact locations of all BFEs to be changed. Send comments to William R. Blanton, Jr., Chief, Engineering Management Branch, Mitigation Directorate, Federal Emergency Management Agency, 500 C Street, SW., Washington, DC 20472. ADDRESSES Town of Ashland Maps are available for inspection at 101 Thompson Street, Ashland, VA 23005. Unincorporated Areas of Hanover County Maps are available for inspection at Department of Public Works, 7497 County Complex Road, Government Administration Building H, Hanover, VA 23069. (Catalog of Federal Domestic Assistance No. 97.022, “Flood Insurance.”) Dated: January 22, 2008. David I. Maurstad, Federal Insurance Administrator of the National Flood Insurance Program, Department of Homeland Security, Federal Emergency Management Agency. [FR Doc. E8-1650 Filed 1-29-08; 8:45 am] BILLING CODE 9110-12-P DEPARTMENT OF TRANSPORTATION National Highway Traffic Safety Administration 49 CFR Part 571 [Docket No. NHTSA-2008-0015] RIN 2127-AG51 Federal Motor Vehicle Safety Standards; Roof Crush Resistance AGENCY: National Highway Traffic Safety Administration (NHTSA), Department of Transportation. ACTION: Supplemental notice of proposed rulemaking (SNPRM). SUMMARY: This document supplements NHTSA's August 2005 proposal to upgrade the Federal motor vehicle safety standard on roof crush resistance. We issued that proposal as part of a comprehensive plan for reducing the serious risk of rollover crashes and the risk of death and serious injury in those crashes. In this document, we ask for public comment on a number of issues that may affect the content of the final rule, including possible variations in the proposed requirements. We are also announcing the release of the results of various vehicle tests conducted since the proposal and are inviting comments on how the agency should factor this new information into its final rule. DATES: Comments must be received on or before March 17, 2008. ADDRESSES: You may submit comments to the docket number identified in the heading of this document by any of the following methods: • *Federal eRulemaking Portal:* go to *http://www.regulations.gov* . Follow the online instructions for submitting comments. • *Mail:* Docket Management Facility, M-30, U.S. Department of Transportation, West Building, Ground Floor, Rm. W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590. • *Hand Delivery or Courier:* West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE., between 9 a.m. and 5 p.m. Eastern Time, Monday through Friday, except Federal holidays. • *Fax:*
(202)493-2251. Regardless of how you submit your comments, you should mention the docket number of this document. You may call the Docket Management Facility at 202-366-9826. *Instructions:* For detailed instructions on submitting comments and additional information on the rulemaking process, see the Public Participation heading of the Supplementary Information section of this document. Note that all comments received will be posted without change to *http://www.regulations.gov* , including any personal information provided. *Privacy Act:* Please see the Privacy Act heading under Rulemaking Analyses and Notices. FOR FURTHER INFORMATION CONTACT: For technical issues: Mr. Christopher Wiacek, Office of Rulemaking, National Highway Traffic Safety Administration, 1200 New Jersey Avenue, SE., Washington, DC 20590. Telephone:
(202)366-4801. For legal issues: Mr. Edward Glancy, Office of the Chief Counsel, National Highway Traffic Safety Administration, 1200 New Jersey Avenue, SE., Washington, DC 20590. Telephone:
(202)366-2992. SUPPLEMENTARY INFORMATION: Table of Contents I. Introduction A. Overview of Standard 216 B. Target Population of Standard 216 C. Summary of 2005 Proposal D. Purpose of this SNPRM II. Release of Vehicle Test Results A. Single-Sided Tests B. Two-Sided Tests III. Discussion A. Pass/Fail Rate of the Vehicle Fleet B. Impact of Electronic Stability Control Safety Standard on Potential Benefits C. Revised Cost and Weight Estimates D. Two-Sided Testing Implications E. Other Factors IV. Comments Sought V. Public Participation VI. Rulemaking Analyses and Notices VII. Proposed Regulatory Text I. Introduction On August 23, 2005, NHTSA published in the **Federal Register** (70 FR 49223) a notice of proposed rulemaking
(NPRM)to upgrade Federal Motor Vehicle Safety Standard (FMVSS) No. 216, *Roof Crush Resistance* . 1 As discussed in the NPRM, this ongoing rulemaking is part of a comprehensive plan for reducing the serious risk of rollover crashes and the risk of death and serious injury in those crashes. In addition to roof crush, other strategies in the comprehensive approach include crash-avoidance initiatives such as electronic stability control which will significantly reduce the number of rollovers, as well as crashworthiness efforts such as ejection mitigation and improved door lock strength which will lower the probability of ejection when rollovers do occur. 1 Docket No. NHTSA-2005-22143. A. Overview of Standard 216 FMVSS No. 216 seeks to reduce deaths and serious injuries resulting from the roof being crushed and pushed into the occupant compartment when the roof strikes the ground during rollover crashes. The standard currently applies to passenger cars, and to multipurpose passenger vehicles, trucks and buses with a GVWR of 2,722 kilograms (6,000 pounds) or less. The standard requires that when a large steel test plate (sometimes referred to as a platen) is placed in contact with the roof of a vehicle and then pressed downward, simulating contact of the roof with the ground during a rollover crash, with steadily increasing force until a force equivalent to 1.5 times the unloaded weight of the vehicle is reached, the distance that the test plate has moved from the point of contact must not exceed 127 mm (5 inches). The criterion of the test plate not being permitted to move more than a specified amount is sometimes referred to as the “platen travel” criterion. Under S5 of the standard, the application of force is limited to 22,240 Newtons (5,000 pounds) for passenger cars, even if the unloaded weight of the car times 1.5 is greater than that amount. B. Target Population of Standard 216 Due to the complex nature of a rollover event and the particularlized effect of each element of the comprehensive and systematic approach taken by the agency to address these crashes, each element addresses a specific segment of the total rollover problem. Table 1 below shows the target population that could potentially benefit from roof crush improvements. 2 The target population for all light vehicles is stratified by injury severity. The table demonstrates how the final target population is derived from the broad category of rollovers by eliminating cases in which roof strength improvements would not be effective. The final target populations are shown in bold at the bottom of the table. Numbers in the table shown in parenthesis are deducted from previous values to arrive at the final target population shown in bold. All other numbers represent the values that result from the restrictions noted in the left column. A full discussion of the basis for the target population is included in the August 2005 Preliminary Regulatory Impact Analysis (PRIA). 2 The target population reflects a very minimal incorporation of ESC in the vehicle fleet. As discussed later in this SNPRM, the final regulatory analysis will be adjusted to reflect full incorporation of ESC into the vehicle fleet. ESC will significantly reduce the number of rollover fatalities, and further reduce the roof crush target population. One modification to that basis should be noted. In the PRIA, it was assumed that in cases in which there were fatal injuries which involved both the head and another body region at the highest MAIS level, the head injury was the cause of death. More recent analysis indicates that only about 2/3 's of these deaths were attributable to the head injury. Based on this, the “not sole injury” category for fatalities was adjusted to reflect the assumption that 67% of these cases would be attributed to head injury, leaving a total of 476 fatalities as the final target population applicable for roof crush. Table 1.—Target Population Potentially Affected by Improved Roof Strength AIS 1 AIS 2 AIS 3-5 Fatalities Non-Convertible Light Vehicles in Rollovers 199,549 37,661 21,933 9,011 Roof-Involved Rollover 164,007 32,862 19,520 7,679 No Fixed Object Collision on Top 153,324 29,346 18,029 6,712 Not Totally Ejected 149,632 25,949 12,638 3,227 Using Safety Restraints 116,135 14,234 9,204 1,835 Front Outboard Seats 103,320 13,457 8,653 1,658 Not 12 Years Old or Younger 101,581 13,418 8,635 1,650 Roof Component Intrusion 64,123 10,339 6,747 1,125 Head, Neck, or Face Injury from Intruding Roof Component 23,147 6,508 3,027 731 Injury—Not MAIS *
(0)(1,872) (1,382)
(209)Injury at MAIS—Not Sole Injury (17,128)
(46)Sole MAIS Injury 6,019 4,346 1,395 476 * This means that the most serious injury was to a portion of the body other than the head, neck or face. The target population relevant to FMVSS No. 216 in Table 1 is thus a relatively small subset of the occupants injured in rollovers. For fatalities, the estimated total for the target population is 5 percent of all non-convertible light vehicle rollover fatalities (476/9,011). For nonfatal injury categories, the estimated total ranges from 3 to 12 percent. The most significant exclusions resulted from requirements that fatalities occurred in rollovers in which
(1)the roof was damaged in a rollover,
(2)the damage was not caused by collision with a fixed object,
(3)the fatally injured occupants were not ejected, and
(4)those occupants were belted. It is important to understand what this Table indicates about the safety potential of addressing roof crush. Even if there were some way to prevent every single rollover death resulting from roof crush, the total lives saved would be 476, not the approximately 10,000 deaths that result from rollover each year. This is why each initiative in NHTSA's comprehensive program to address the different aspects of the rollover problem is so important. Each initiative has a different target population. We have initiatives in place to: 1. Reduce the occurrence of rollover crashes (e.g., the requirement for Electronic Stability Control on all light vehicles and the NCAP rollover ratings), 2. Keep occupants inside the vehicle when rollovers occur (e.g., NHTSA's unstinting commitment to get passengers to buckle their seat belts every time they ride in a vehicle, as well as the requirement for enhanced door latches and the forthcoming new requirement for ejection mitigation), and 3. Better protect the occupants kept inside the vehicle during the rollover (this rule to require enhanced roof crush resistance). Each of these three initiatives must work together to address the various aspects of the rollover problem. However, it is important to understand which portion of the rollover problem can be addressed by each of these three initiatives, so that there is a clear and correct understanding of the safety benefits potentially associated with each of the different types of actions to reduce rollover deaths and injuries. C. Summary of 2005 Proposal To better address fatalities and injuries occurring in roof-involved rollover crashes, we proposed in 2005 to extend the application of the standard to vehicles with a GVWR of up to 4,536 kilograms (10,000 pounds), and to strengthen the requirements of FMVSS No. 216 by mandating that the vehicle roof structures withstand a force equivalent to 2.5 times the unloaded vehicle weight, and eliminating the 22,240 Newtons (5,000 pounds) force limit for passenger cars. Further, in recognition of the fact that the pre-test distance between the interior surface of the roof and a given occupant's head varies from vehicle model to vehicle model, we proposed to regulate roof strength by requiring that the crush not exceed the available headroom. Under the proposal, this requirement would replace the current limit on test plate movement. The proposed new limit would prohibit any roof component from contacting the head of a seated 50th percentile male dummy when the roof is subjected to a force equivalent to 2.5 times the unloaded vehicle weight. We note that this value is sometimes referred to as the strength-to-weight ratio (SWR), e.g., a SWR of 1.5, 2.5, and so forth. D. Purpose of This SNPRM The agency has been carefully analyzing the numerous comments it received on its proposal. In addition, it has been analyzing the various additional vehicle tests, including both single-side tests and two-sided tests, 3 conducted since the NPRM. In this document, we are inviting comments on how the agency should factor this new information into its decision. While the NPRM focused on a specified force equivalent to 2.5 times the unloaded vehicle weight, the agency could adopt a higher or lower value for the final rule. With respect to two-sided vehicle testing, we believe that, with the additional tests conducted by the agency, there is now sufficient available information for the agency to consider a two-sided requirement as an alternative to the single-sided procedure described in the NPRM. The agency plans to evaluate both the single-sided and two-sided testing alternatives for the final rule. We are requesting comments that will help us reach a decision on that issue. 3 Note that in the most recent agency testing, headroom reduction had been assessed using a head positioning fixture in lieu of a 50th percentile dummy. Reports on these tests explain the procedure and type of fixture used to assess headroom reduction. (As explained elsewhere in this document, these test reports are being made available to the public through the agency's internet vehicle crash test database.) Please note further that the agency is considering whether this fixture should be specified in the final rule. In developing a final rule, the agency will consider the comments submitted on both the August 2005 NPRM and this document. Thus, there is no need for persons to re-submit the comments they provided for the NPRM. We note that we are generally not discussing the comments in this document, except for a few brief references that are relevant to the potential economic impact of our proposal. We also note that the proposed regulatory text in this document includes both the single-sided and two-sided test requirement alternatives. The fact that the proposed regulatory text for the two alternatives does not reflect other changes suggested by commenters on the NPRM does not mean that we will not consider those recommended changes in developing a final rule. We are providing a 45-day comment period. We believe this is appropriate given that this is an SNPRM with a more limited focus than the NPRM, and given the need to comply with a statutory deadline. II. Release of Vehicle Test Results The test reports for the additional vehicle tests conducted by NHTSA are being made available to the public through the agency's internet vehicle crash test database. We are placing a memorandum in the docket which provides the Web address for that database and lists the vehicle models and test numbers that are needed to reference the information in the database. The agency incorporates by reference these test reports as part of the record for this rulemaking. A. Single-Sided Tests Since the publication of the NPRM, the agency has conducted 35 additional single-sided tests. In this testing, the force was applied to one side of the roof over the front seat area. Force was applied until there was 127 mm (5 inches) of platen travel, unless head contact occurred first. The strength of the roof was measured prior to any subsequent testing the agency may have conducted on the second side. The agency is releasing these data to the public in conjunction with this document. A summary of the test results is presented in the Table 2 below. Table 2.—Single-Sided Test Results Vehicle Unloaded vehicle weight
(kg)Peak strength within 127 mm N SWR Peak strength prior to head contact N SWR Platen displacement at head contact
(mm)2006 VW Jetta 1,443 72,613 5.1 72,613 5.1 158 2007 Scion tC 1,326 59,749 4.6 59,749 4.6 113 2006 Volvo XC90 2,020 90,188 4.6 N/A N/A N/A 2006 Honda Civic 1,251 55,207 4.5 55,207 4.5 177 2007 Toyota Tacoma 1,489 64,441 4.4 64,441 4.4 123 2006 Mazda 5 1,535 66,621 4.4 66,621 4.4 155 2007 Toyota Camry 1,468 62,097 4.3 62,097 4.3 N/A 2007 Toyota Yaris 1,038 41,073 4 41,073 4 115 2006 Ford 500 1,657 63,181 3.9 63,181 3.9 150 2007 Nissan Frontier 1,615 62,828 3.9 62,828 3.9 167 2006 Subaru Tribeca 1,907 72,306 3.9 72,306 3.9 112 2006 Mitsubishi Eclipse 1,485 51,711 3.6 51,711 3.6 127 2006 Hummer H3 2,128 70,264 3.4 70,264 3.4 185 2006 Hyundai Sonata 1,505 46,662 3.2 46,662 3.2 131 2007 Dodge Caravan 1,759 52,436 3 52,436 3 N/A 2006 Chrysler Crossfire 1,357 38,179 2.9 38,179 2.9 107 2004 Honda Accord 1,413 38,281 2.8 38,281 2.8 140 2007 Saturn Outlook* 2,133 57,222 2.7 57,222 2.7 N/A 2006 Ford Mustang 1,527 40,101 2.7 41,822 2.8 132 2005 Buick Lacrosse 1,590 40,345 2.6 40,345 2.6 126 2006 Sprinter Van* 1,946 49,073 2.6 N/A N/A N/A 2004 Cadillac SRX 1,961 50,346 2.6 50,346 2.6 138 2007 Honda CRV 1,529 38,637 2.6 38,637 2.6 N/A 2007 Chrysler 300 1,684 41,257 2.5 41,257 2.5 N/A 2005 Buick Lacrosse 1,588 37,196 2.4 37,196 2.4 123 2006 Honda Ridgeline 2,036 47,334 2.4 47,334 2.4 172 2007 Ford F-150* 2,413 54,829 2.3 54,829 2.3 N/A 2007 Buick Lucerne 1,690 38,268 2.3 38,268 2.3 N/A 2004 Chevrolet 2500 HD* 2,450 55,934 2.3 56,294 2.3 171 2007 Pontiac G6 1,497 33,393 2.3 33,393 2.3 124 2007 Chevrolet Express* 2,471 55,038 2.3 55,038 2.3 N/A 2007 Jeep Grand Cherokee 1,941 41,582 2.2 41,582 2.2 117 2007 Chevrolet Tahoe* 2,462 49,878 2.1 49,878 2.1 N/A 2006 Dodge Ram* 2,287 37,596 1.7 42,578 1.9 158 2003 Ford F-250* 2,658 44,776 1.7 44,776 1.7 205 *GVWR greater than 6,000 pounds We observed from this recent testing that the range of SWRs for vehicles with a GVWR of 6,000 pounds (2722 kilograms) or less tended to be higher than the range of SWRs for vehicles with a GVWR greater than 6,000 pounds (2722 kilograms). The SWR of many late model vehicles with a GVWR of 6,000 pounds (2722 kilograms) or less was substantially higher than the 2.5 value the agency focused on in the NPRM. Conversely, only two vehicles we tested with a GVWR greater than 6,000 pounds (2722 kilograms) exceeded the 2.5 value. We note that the data presented in these tables do not factor in the full spectrum of weight ranges for the models tested. The SWR for each model was calculated using the unloaded vehicle weight
(UVW)of the tested vehicle rather than the maximum vehicle weight. In comments on the NPRM, manufacturers said that vehicles would have to be designed to comply in their maximum weight configuration. NHTSA agrees with this comment and will reflect maximum weight configurations in the final rule analysis. We request comments on any other steps the agency should take in factoring these new test data into its decisions for the final rule. B. Two-Sided Tests In the NPRM, the agency summarized the testing it had conducted to evaluate the strength of the second side of the roof of vehicles whose first side had already been tested. In this testing, after the force was applied to one side of the roof over the front seat area of a vehicle, the vehicle was repositioned and force was then applied on the opposite side of the roof over the front seat area. In performing these tests on both sides of a vehicle, the agency used the platen angle currently specified in FMVSS No. 216 (5° × 25°). We concluded that the strength of the roof on the second side of some vehicles may have been increased or decreased as a result of the deformation of the first side of the roof. The agency indicated that it planned to conduct further research before proposing rulemaking in this area. The agency has expanded the series of two-sided roof crush tests discussed in the NPRM. The agency has now conducted a total of 26 sequential two-sided tests, as part of its evaluation, and is also releasing these data to the public in conjunction with this document. A summary of the test results is presented in the following Table 3. Table 3.—Results of 2-Sided Testing (5° × 25° Platen Angle) Vehicle Peak SWR prior to 127 mm of platen travel or head contact 1st side 2nd side Peak force change (percent) 2007 Chevrolet Express 4 2.3 1.7 −27.3 2007 Jeep Grand Cherokee 2.2 1.6 −27.1 2007 Pontiac G6 2.3 1.7 −23.8 2005 Lincoln LS * 2.6 2.0 −21.3 2007 Saturn Outlook 2.7 2.2 −20.8 2003 Ford Crown Victoria * 2.0 1.7 −19.5 2007 Ford F-150 2.3 1.9 −19.0 2007 Chevrolet Tahoe 2.1 1.7 −16.4 2007 Toyota Yaris 4.0 3.4 −15.8 2005 Buick LaCrosse 2.6 2.2 −13.5 2007 Toyota Tacoma 4.4 3.9 −12.2 2007 Buick Lucerne 2.3 2.1 −10.8 2003 Chevrolet Impala * 2.9 2.5 −9.9 2004 Lincoln LS * 2.5 2.2 −8.7 2006 Subaru Tribeca 3.9 3.5 −8.3 2007 Scion tC 4.6 4.3 −6.7 2006 Chrysler Crossfire 2.9 2.7 −5.6 2007 Dodge Caravan 3.0 2.9 −5.3 2007 Honda CRV 2.6 2.5 −4.9 2005 Buick LaCrosse 2.4 2.3 −3.4 2004 Nissan Quest * 2.8 2.7 −3.0 2001 GMC Sierra * 1.9 1.9 −1.3 2007 Chrysler 300 2.5 2.5 1.6 2004 Chrysler Pacifica * 2.2 2.4 7.0 2007 Toyota Camry 4.3 4.7 9.0 2004 Land Rover Freelander * 1.7 2.0 19.2 * Crush of first side stopped at windshield cracking. 4 Between the first and second side tests, the front door on the tested side was opened. Because of damage to the vehicle during the first side test, the door would not properly close. The door was clamped until the latch engaged, locking the door in place. This may have compromised the structural integrity of the roof and reduced the measured peak load on the second side. For the first eight tests (those with asterisks in the table), testing of the first side of the vehicle was conducted until the windshield cracked. This occurred between 90 and 100 mm (3.54 and 3.94 inches) of platen travel for all vehicles except the Nissan Quest which required 135 mm (5.31 inches) of platen travel before the windshield cracked. The second side was then tested for 254 mm (10 inches) of platen travel. For all other tests, the first side was conducted to 127 mm (5 inches) of platen travel unless head contact occurred first. The second side was then tested for 254 mm (10 inches) of platen travel. We note that in all 26 tests, the windshield cracked before completion of the first side test. In the first eight tests, the peak SWR was recorded at the time the windshield cracked on the first side. For all other testing, the SWR was recorded prior to 127 mm (5 inches) of platen travel or prior to head contact, whichever occurred first. The two-sided test results show that the first side test generally produces a weakening of the structure. This is shown by the fact that the recorded SWR for the second side is generally lower than for the first side. On average, the peak strength for the second side was reduced by 8.7 percent. However, for several of the vehicles, we observed considerably higher reductions in peak strength. Of the 25 vehicles tested, excluding the Chevrolet Express, six experienced reductions in strength of 19 percent or greater. With respect to two-sided vehicle testing, we believe that the post-NPRM tests provide the agency with sufficient additional information for the agency to now consider a two-sided test requirement for the final rule. However, as discussed in the following sections, the agency seeks comment on the relative trade offs between the single-sided and two-sided test procedures. III. Discussion Based upon the results of the testing described above, the agency is contemplating various alternatives for a final rule. Each of the alternatives will directly affect the current fleet failure rate estimates, vehicle design changes and vehicle content necessary to meet those alternatives, and consequent benefits and costs. The agency has not completed cost/benefit analyses for these various alternatives, however, the agency will ensure that its decisions about these alternatives result in a final rule that is cost beneficial, as contemplated by Executive Order 12866. Public comments submitted in response to the NPRM and research conducted by NHTSA indicate some general conclusions that can be drawn regarding the directional impact of these alternatives, as well as subsequent changes in vehicle content and other factors that may influence the final rule. The August 2005 PRIA examined the proposed SWR of 2.5 and the alternative SWR of 3.0 times the unloaded vehicle weight. Estimated costs ranged from $88 to 95 million for the 2.5 SWR alternative and $1.2 to $1.3 billion for the 3.0 SWR alternative. Benefits were estimated to be 13 to 44 fatalities and 498 to 793 nonfatal injuries prevented for the 2.5 alternative, and 49 to 135 fatalities and 1540 to 2151 nonfatal injuries prevented for the 3.0 alternative. The estimated impacts of the final rule will be changed by a number of factors. These include: A. Pass/Fail Rate of the Vehicle Fleet In response to the NPRM, manufacturers commented that NHTSA's estimates underestimated the portion of the vehicle fleet that would require changes. The manufacturers noted that NHTSA's estimates were based on individual vehicles' actual weights, but that manufacturers would have to design roof structures to meet the maximum weight that each body design would be required to carry. Thus, for example, test results from a vehicle with a four-cylinder engine and manual transmission might not be indicative of the same vehicle with a six-cylinder engine and automatic transmission option, even though they share the same body design and roof structure. The agency agrees with this comment and will make appropriate adjustments in its revised analysis for the final rule. In the NPRM, the agency estimated that 32 percent of the vehicle fleet would have to be changed to meet the 2.5 proposal, whereas manufacturers commented that the portion was over 80 percent. Based on the agency's testing, more recent vehicle designs tested appear to have stronger roofs. Therefore, it is not yet clear what the actual failure rate will be. However, at this time, it appears likely that the impact of this adjustment will be to increase both the costs and benefits of the rule. B. Impact of Electronic Stability Control Safety Standard on Potential Benefits The PRIA for the August 2005 NPRM to amend FMVSS No. 216 examined the model year
(MY)2005 fleet. During MY 2005, Electronic Stability Control
(ESC)was voluntarily installed on roughly 18% of the new light vehicle fleet, and the PRIA took this into account. However, NHTSA published a proposal in September 2006 and a final rule 5 in April 2007 requiring ESC on 100% of passenger cars and of light trucks, multipurpose passenger vehicles, and vans (LTVs), effective September 1, 2011. Therefore, the FRIA for the final rule upgrading FMVSS No. 216 will adjust the target population for this rulemaking to reflect the ESC mandate. Since ESC is a highly effective countermeasure, preventing roughly half of all rollovers in passenger cars and LTVs, this adjustment will significantly reduce both the target population and the safety benefits associated with FMVSS No. 216. 5 66 FR 17236. C. Revised Cost and Weight Estimates In the PRIA, NHTSA based its cost estimates on 4 vehicles: The 1997 Plymouth Neon, the 1999 Ford E-150 Van, the 1997 Dodge Caravan, and the 1998 Chevrolet S-10 pickup. These vehicles were used because they were the only vehicles for which the agency had finite element models which could be used to simulate the impact of roof design changes on roof strength. The agency used these vehicles to impute costs for the overall fleet based on the relative roof strength of a sample of tested vehicles. A similar procedure was used for vehicle weight changes. The PRIA estimated that the average cost per affected vehicle would be approximately $11 to meet the 2.5 SWR alternative and $51 for the 3.0 SWR alternative, with individual model costs as high as $16 for the 2.5 alternative and $84 for the 3.0 alternative. The PRIA also estimated average weight increases ranging from 2 to 14 kilograms (4 to 30 pounds). Weight is a factor in the analysis because it influences both fuel economy, and the vehicle's center of gravity which can influence the vehicle's tendency to roll over. In response, the Alliance of Automobile Manufacturers (Alliance) submitted an analysis of costs and weights for 2 vehicle types—a large SUV and a large pickup truck. 6 The Alliance estimates were based on engineering studies from a variety of manufacturers and represented a range of results for each vehicle type. The Alliance estimated that variable unit costs for a large SUV would range from $38 to $58 to meet a 2.5 SWR alternative, $60 to $90 to meet a 3.0 SWR alternative and $110 to $130 to meet a 3.5 SWR alternative. Based on NHTSA cost studies, total costs including overhead, markup and profit could be 50 percent higher than these variable costs. The Alliance estimated the corresponding weight increases for these scenarios to be 27 to 30 kilograms (60 to 67 pounds) for the 2.5 SWR, 68 to 122 kilograms (150 to 270 pounds) for the 3.0 SWR, and 113 to 245 kilograms (250 to 540 pounds) for the 3.5 SWR. For the large pickup truck the Alliance estimated that variable unit costs would range from $55 to $185 to meet a 2.5 SWR alternative, $100 to $200 to meet a 3.0 SWR alternative and $165 to $525 to meet a 3.5 SWR alternative. The Alliance estimate for corresponding weight increases for these scenarios were 17 to 31 kilograms (38 to 68 pound) for the 2.5 SWR, 39 to 118 kilograms (85 to 260 pounds) for the 3.0 SWR, and 54 to 236 kilograms (120 to 520 pound) for the 3.5 SWR. 6 *See* Docket No. NHTSA-2005-22143-249. The Alliance also contracted an independent study by Magna Steyr on the feasibility of modifying a crew cab pickup for compliance with the NPRM proposal (2.5 SWR). The study concluded that meeting the proposal in a 3-year lead time was feasible, but would add 33 kilograms (73 pounds) and $76 to $98 in variable costs. It also found that if enough leadtime were provided to allow implementation during a new production cycle, higher strength materials were feasible in conjunction with new tooling and this could result in a 5 kilogram (11 pound) savings in weight relative to the base vehicle. The Alliance data represent industry estimates of costs and weight impacts for the two types of vehicles—large SUVs and large pickup trucks—for which higher SWRs are likely to pose the most difficult challenges and result in the largest cost and weight penalties. However, these types of vehicles represent only a small portion of new vehicle sales (approximately 9 percent) and their design challenges are unlikely to be representative of the bulk of the vehicle fleet. The Alliance did not provide estimates for other vehicle types—passenger cars, light pickups, crossover SUVs, etc. The agency believes that meeting a higher SWR may be significantly easier for the vehicle types not submitted by the Alliance based upon our fleet results. The agency will consider the Alliance estimates and results from its own research when developing the Final Regulatory Impact Analysis, but at this time it is unclear whether unit costs will change significantly for vehicles other than large pickups and large SUVs. The agency has also conducted additional tear down studies. A study 7 conducted by The Ohio State University examined the Volvo XC90 and the Ford Explorer. The study found that the XC-90 roof had roughly 1/3 more structural parts than the Explorer, and that implementing some of the XC-90 design concepts in the Ford Explorer would increase material and tooling costs by $81 and weight by 15 kilograms (33 pounds). Additional work based on finite element models and cost teardown studies conducted by Ludtke Associates and the National Crash Analysis Center 8 found that strengthening the 2003 Ford Explorer to 3.0 SWR would raise the vehicle's price by $33 to $35 and increase its weight by 5 to 10 kilograms (10 to 23 pounds). They also examined a 2000 Ford Taurus. The study indicated that raising the Taurus to a 3.0 SWR would increase its price by $175 to $204, and increase its weight by 7 to 12 kilograms (15 to 27 pounds). 7 Available in the docket of this notice: Hutter, Erin E., “Improving Roof Crush Performance of a Sport Utility Vehicle,” The Ohio State University, 2007. 8 Available in the docket of this notice: “Cost, Weight, and Lead Time Analysis Roof Crush Upgrade,” Task Order No. 007. D. Two-Sided Testing Implications The two-sided testing conducted by NHTSA thus far indicate an average difference of approximately 8 percent lower peak force for the second side in vehicles under 2,722 kilograms (6,000 pounds) GVWR 9 and 17 percent lower peak force for the second side in vehicles over 2,722 kilograms (6,000 pounds) GVWR. 10 Thus, the adoption of a two-sided alternative would result in some increase in the portion of the fleet that would fail the roof crush requirements beyond the portion estimated in the NPRM. This would increase the benefits as well as the costs of this rulemaking. 9 Refers to vehicles with a GVWR equal to or less than 2,722 kilograms (6,000 pounds). 10 Refers to vehicles with a GVWR greater than 2,722 kilograms (6,000 pounds). We have conducted an analysis to examine the relative impact of one-sided testing vs. two-sided testing, based primarily on the results of the agency's own FMVSS No. 216 testing program. Since the publication of the October 2001 request for comment (66 FR 53376), the agency has conducted roof strength testing on 69 vehicles. Although these tests were conducted on specific vehicles, for this exercise, the results were adjusted to reflect the maximum unloaded vehicle weight configuration for each make/model. The agency tested 21 vehicles with GVWRs less than 2,722 kilograms (6,000 pounds) under a two-sided test regime. Eleven of these vehicles passed a 2.5 SWR on both the first and second side tested. Only five vehicles passed a 3.0 SWR on both sides and only four passed a 3.5 SWR. The agency also conducted two-sided tests on five vehicles with GVWRs over 2,722 kilograms (6,000 pounds). None of these vehicles passed a 2.5 or greater SWR. The agency also has single-sided testing data on 32 vehicles with GVWRs less than 2,722 kilograms (6,000 pounds) and 11 vehicles with GVWRs over 2,722 kilograms (6,000 pounds). The roof strength results for this sample of 69 vehicles were then sales weighted to estimate the relative pass-fail rates that might result for single-sided and two-sided test procedure alternatives. The estimates show nearly 100 percent of vehicles over 2,722 kilograms (6,000 pounds) GVWR failed under all scenarios. The vehicles with GVWR under 2,722 kilograms (6,000 pounds) had higher failure rates for the two-sided tests when compared to the single-sided procedure. At a SWR of 2.5, the lighter vehicles are estimated to have a failure rate of 45 percent for single-sided and 67 percent for two-sided tests. The failure rate increases with higher SWR scenarios. A summary of the results is presented in the following Table 4. Table 4.—Estimated Fleet Failure Rates Based on GVWR GVWR 2.5 SWR 3.0 SWR 3.5 SWR Two-Sided Testing < 2,722 kg GVWR 67.2% 78.6% 85.0% > 2,722 kg GVWR 100.0% 100.0% 100.0% Total 75.1% 83.7% 88.6% Single-Sided Testing < 2,722 kg GVWR 44.5% 76.9% 80.9% > 2,722 kg GVWR 98.9% 100.0% 100.0% Total 57.6% 82.5% 85.5% E. Other Factors In the NPRM, the agency estimated benefits based on post-crash headroom, the only basis for which a statistical relationship with injury reduction had been established. In that analysis, the agency estimated that the proposed 2.5 SWR requirement would prevent 13 to 44 fatalities. 11 11 This range reflects two different methodologies that were examined. More recently, the agency has estimated benefits based on the relationship between intrusion and the probability of injury. This relationship was not established when the NPRM was published, but with the additional years of data available, a statistically significant relationship between intrusion and injury for belted occupants has since been established. A study regarding this relationship has undergone peer review and is available in the docket. 12 This broader relationship, together with other factors, including the higher failure rates resulting from adjustments for maximum vehicle weight and the higher effective SWRs that result from this same issue will likely lead to slightly higher benefits than was estimated in the NPRM. 12 Available in the docket of the notice: Strashny, Alexander, “The Role of Vertical Roof Intrusion and Post-Crash Headroom in Predicting Roof Contact Injuries to the Head, Neck, or Face during FMVSS 216 Rollovers.” In the NPRM, NHTSA estimated the cost of meeting the proposed 2.5 SWR single-sided test requirement at $16-$17 13 for vehicles that do not already meet the standard, consisting of roughly $11 for design changes and $5-$6 for added lifetime fuel consumption. 13 Under a 7% and 3% discount rate, respectively. The agency believes that these cost estimates may increase for several reasons. The first is that manufacturers stated that vehicle body platforms must be designed to their heaviest possible design configuration. This means that a body platform that supports several different engine, transmission, and suspension options must be strong enough to pass the test requirements under the maximum weighted combination of these options. This could increase the effective SWR of the entire body platform and this would increase the average cost and weight impact of the required design changes. This would primarily be an issue for large trucks and SUVs, which are designed with a wide range of optional performance packages. It would be much less of a factor for passenger cars. A second reason costs might rise is that predicted gasoline prices may be higher than prices predicted in the NPRM. The NPRM fuel cost estimates were based on forecasts from the Energy Information Administration (EIA), which predicted an average pump price of roughly $1.46/gallon (2002 dollars) in 2007. The final rule will be based on EIA's latest predictions. It is expected that EIA's predictions will be higher than its earlier ones. A third reason costs may rise is that the cost estimates NHTSA used for the NPRM assumed single-sided tests. For the two-sided testing program alternative, the agency found an average difference of approximately 8-17 percent lower peak force for the second side (depending on vehicle weight class). Thus, some vehicle designs may need added strengthening to meet a two-sided test relative to a single-sided test. Regardless of which alternative is adopted in the final rule, the agency will ensure that the final rule is cost beneficial, as contemplated by Executive Order 12866. IV. Comments Sought The agency requests comments on the costs of meeting the single-sided and two-sided testing alternative requirements for different types of vehicles for the proposed SWR of 2.5, as well as the alternatives of 3.0 and 3.5. 1. In the single-sided test results, the agency observed that vehicles under 6,000 pounds achieved higher SWR levels than did those vehicles over 6,000 pounds. Should the agency consider different stringency requirements for vehicles according to their weight class? Will different design strategies be necessary to meet the requirements for vehicles under or over 6,000 pounds? What are the cost implications associated with different stringency requirements and different design strategies? 2. In the agency's two-sided testing, an average reduction of about 8% was observed in the second side SWR compared to the first side for vehicles under 6,000 pounds, compared to an average 17% reduction for those over 6,000 pounds. Table 4 also indicates a much higher failure rate for two-sided testing compared to a single-sided requirement, and appears to indicate that fleet failure rates (and consequently benefits) for a two-sided test at a 2.5 SWR would be comparable to a single-sided test at a higher SWR. What are the relative costs associated with, for example, a two-sided requirement at 2.5 SWR versus a single-sided test at 3.0 SWR? If comparable benefits can be achieved with a single-sided test at a higher SWR requirement compared to a two-sided test at a lower SWR level, are there other considerations the agency should include in the FRIA? 3. If a two-sided alternative is pursued in the final rule, will different design strategies be required to meet the requirements for vehicles under or over 6,000 pounds? What are the cost implications associated with these strategies? V. Public Participation How Do I Prepare and Submit Comments? Your comments must be written and in English. To ensure that your comments are correctly filed in the Docket, please include the docket number of this document in your comments. Your comments must not be more than 15 pages long. 14 We established this limit to encourage you to write your primary comments in a concise fashion. However, you may attach necessary additional documents to your comments. There is no limit on the length of the attachments. 14 *See* 49 CFR 553.21. Please submit your comments by any of the following methods: • *Federal eRulemaking Portal:* go to *http://www.regulations.gov.* Follow the online instructions for submitting comments. • *Mail:* Docket Management Facility, M-30, U.S. Department of Transportation, West Building, Ground Floor, Rm. W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590. • *Hand Delivery or Courier:* West Building, Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE., between 9 a.m. and 5 p.m. Eastern Time, Monday through Friday, except Federal holidays. • *Fax:*
(202)493-2251. If you are submitting comments electronically as a PDF (Adobe) file, we ask that the documents submitted be scanned using Optical Character Recognition
(OCR)process, thus allowing the agency to search and copy certain portions of your submissions. 15 15 Optical character recognition
(OCR)is the process of converting an image of text, such as a scanned paper document or electronic fax file, into computer-editable text. Please note that pursuant to the Data Quality Act, in order for substantive data to be relied upon and used by the agency, it must meet the information quality standards set forth in the OMB and DOT Data Quality Act guidelines. Accordingly, we encourage you to consult the guidelines in preparing your comments. OMB's guidelines may be accessed at *http://www.whitehouse.gov/omb/fedreg/reproducible.html.* DOT's guidelines may be accessed at * http:// dmses.dot.gov/submit/DataQualityGuidelines.pdf. * How Can I Be Sure That My Comments Were Received? If you submit your comments by mail and wish Docket Management to notify you upon its receipt of your comments, enclose a self-addressed, stamped postcard in the envelope containing your comments. Upon receiving your comments, Docket Management will return the postcard by mail. How Do I Submit Confidential Business Information? If you wish to submit any information under a claim of confidentiality, you should submit three copies of your complete submission, including the information you claim to be confidential business information, to the Chief Counsel, NHTSA, at the address given above under FOR FURTHER INFORMATION CONTACT. When you send a comment containing information claimed to be confidential business information, you should include a cover letter setting forth the information specified in our confidential business information regulation. 16 16 *See* 49 CFR 512. In addition, you should submit a copy, from which you have deleted the claimed confidential business information, to the Docket by one of the methods set forth above. Will the Agency Consider Late Comments? We will consider all comments received before the close of business on the comment closing date indicated above under DATES. To the extent possible, we will also consider comments received after that date. Therefore, if interested persons believe that any new information the agency places in the docket affects their comments, they may submit comments after the closing date concerning how the agency should consider that information for the final rule. If a comment is received too late for us to consider in developing a final rule (assuming that one is issued), we will consider that comment as an informal suggestion for future rulemaking action. How Can I Read the Comments Submitted By Other People? You may read the materials placed in the docket for this document (e.g., the comments submitted in response to this document by other interested persons) at any time by going to *http://www.regulations.gov.* Follow the online instructions for accessing the dockets. You may also read the materials at the Docket Management Facility by going to the street address given above under ADDRESSES. The Docket Management Facility is open between 9 a.m. and 5 p.m. Eastern Time, Monday through Friday, except Federal holidays. VI. Rulemaking Analyses and Notices A. Executive Order 12866 and DOT Regulatory Policies and Procedures NHTSA has considered the impact of this rulemaking action under Executive Order 12866 and the Department of Transportation's regulatory policies and procedures. The Office of Management and Budget reviewed this rulemaking document under E.O. 12866, “Regulatory Planning and Review.” This rulemaking action has been determined to be significant under Executive Order 12866 and the DOT Policies and Procedures because of Congressional and public interest. Our current understanding of the benefits and costs of this rulemaking is set forth on the pages above. NHTSA will prepare a Final Regulatory Impact Analysis
(FRIA)describing the costs and benefits of this rulemaking action for the final rule. The FRIA will analyze alternatives considered by the agency and the final rule as issued, and will reflect consideration of comments addressing costs and benefits. The agency invites comments concerning how the alternatives to the proposal discussed in today's document could affect costs and benefits. B. Privacy Act Anyone is able to search the electronic form of all comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review DOT's complete Privacy Act Statement in the **Federal Register** published on April 11, 2000 (Volume 65, Number 70; Pages 19477-78) or you may visit *http://docketsinfo.dot.gov/.* Rulemaking Analyses and Notices In the August 2005 NPRM, the agency discussed relevant requirements related to the Regulatory Flexibility Act, the National Environmental Policy Act, Executive Order 13132 (Federalism), the Unfunded Mandates Act, Civil Justice Reform, the National Technology Transfer and Advancement Act, and the Paperwork Reduction Act. The variations in the proposal discussed in this document do not affect the agency's analyses in those areas. NHTSA will address comments in these areas in connection with the final rule. VII. Proposed Regulatory Text List of Subjects in 49 CFR Part 571 Motor vehicle safety, Tires. In consideration of the foregoing, NHTSA proposes to amend 49 CFR part 571 as follows: PART 571—[AMENDED] 1. The authority citation of Part 571 continues to read as follows: Authority: 49 U.S.C. 322, 30111, 30115, 30166 and 30177; delegation of authority at 49 CFR 1.50. Alternative 1 (Two-Sided Test) 2. Amend § 571.216 by: a. Revising S3 to read as set forth below; b. Adding to S4, in alphabetical order, new definitions of “Convertible” and “Roof component;” c. Revising S5 to read as set forth below; d. Removing S5.1; e. Revising S7.1 through S7.6 to read as set forth below; f. Adding S7.7 to read as set forth below; and g. Removing S8 through S8.4. The revisions and additions read as follows: § 571.216 Standard No. 216; Roof crush resistance. S3. *Application.* This standard applies to passenger cars, and to multipurpose passenger vehicles, trucks and buses with a GVWR of 4,536 kilograms (10,000 pounds) or less. However, it does not apply to—
(a)School buses;
(b)Vehicles that conform to the rollover test requirements (S5.3) of Standard No. 208 (§ 571.208) by means that require no action by vehicle occupants;
(c)Convertibles, except for optional compliance with the standard as an alternative to the rollover test requirement (S5.3) of Standard No. 208; or
(d)Vehicles manufactured in two or more stages, other than chassis cabs, that conform to the roof crush requirements
(S4)of Standard No. 220 (§ 571.220). S4. *Definitions.* *Convertible* means a vehicle whose A-pillars are not joined with the B-pillars (or rearmost pillars) by a fixed, rigid structural member. *Roof component* means the A-pillar, B-pillar, roof side rail, front header, rear header, roof, and all interior trim in contact with these components. S5. *Requirements.* When the test device described in S6 is used to apply a force to a vehicle's roof in accordance with S7, first to one side of the roof and then to the other side of the roof, no roof component or portion of the test device may contact the head or the neck of the seated Hybrid III 50th percentile male dummy specified in 49 CFR Part 572, Subpart E. The maximum applied force in Newtons is any value up to and including 2.5 times the unloaded vehicle weight of the vehicle, measured in kilograms and multiplied by 9.8. S7.1 Secure the vehicle in accordance with S7.1(a) through (d).
(a)Support the vehicle off its suspension at a longitudinal vehicle attitude of 0 degrees ± 0.5 degrees. Measure the longitudinal vehicle attitude along both the driver and passenger sill. Determine the lateral vehicle attitude by measuring the vertical distance between a level surface and a standard reference point on the bottom of the driver and passenger side sills. The difference between the vertical distance measured on the driver side and the passenger side sills shall not exceed ± 1 cm.
(b)Secure the vehicle with four stands. The locations for supporting the vehicle are defined in S7.1(c) or (d). Welding is permissible. The vehicle overhangs are not supported. Chains and wire rope are not used to secure the vehicle. Fix all non-rigid body mounts to prevent motion of the body relative to the frame. Close all windows, close and lock all doors, and secure any moveable or removable roof structure in place over the occupant compartment. Remove roof racks or other non-structural components.
(c)For vehicles with manufacturer's designated jacking locations, locate the stands at or near the specified location.
(d)For vehicles with undefined jacking locations, generalized jacking areas, or jacking areas that are not part of the vehicle body or frame, such as axles or suspension members, locate two stands in the region forward of the rearmost axle and two stands rearward of the forwardmost axle. All four stands shall be located between the axles on either the vehicle body or vehicle frame. S7.2
(a)Adjust the seats and steering controls in accordance with S8.1.2 and S.8.1.4 of 49 CFR 571.208.
(b)Place adjustable seat backs in the manufacturer's nominal design riding position in the manner specified by the manufacturer. Place any adjustable anchorages at the manufacturer's nominal design position for a 50th percentile adult male occupant. Place each adjustable head restraint in its lowest adjustment position. Adjustable lumbar supports are positioned so that the lumbar support is in its lowest adjustment position. S7.3 Position the Hybrid III 50th percentile male dummy specified in 49 CFR Part 572, Subpart E in accordance with S10.1 through S10.6.2.2 of 49 CFR 571.208, in the front outboard designated seating position on the side of the vehicle being tested. S7.4 Orient the test device as shown in Figure 1 of this section, so that—
(a)Its longitudinal axis is at a forward angle (in side view) of 5 degrees below the horizontal, and is parallel to the vertical plane through the vehicle's longitudinal centerline;
(b)Its transverse axis is at an outboard angle, in the front view projection, of 25 degrees below the horizontal. S7.5 Maintaining the orientation specified in S7.4—
(a)Lower the test device until it initially makes contact with the roof of the vehicle.
(b)Position the test device so that—
(1)The longitudinal centerline on its lower surface is within 10 mm of the initial point of contact, or on the center of the initial contact area, with the roof; and
(2)The midpoint of the forward edge of the lower surface of the test device is within 10 mm of the transverse vertical plane 254 mm forward of the forwardmost point on the exterior surface of the roof, including windshield trim, that lies in the longitudinal vertical plane passing through the vehicle's longitudinal centerline. S7.6 Apply force so that the test device moves in a downward direction perpendicular to the lower surface of the test device at a rate of not more than 13 millimeters per second until reaching the force level specified in S5. Guide the test device so that throughout the test it moves, without rotation, in a straight line with its lower surface oriented as specified in S7.4(a) and S7.4(b). Complete the test within 120 seconds. S7.7 Repeat the test on the other side of the vehicle. Alternative 2 (Single-Sided Test) 3. Amend § 571.216 by: a. Revising S3 to read as set forth below; b. Adding to S4, in alphabetical order, new definitions of “Convertible” and “Roof component;” c. Revising S5 to read as set forth below; d. Removing S5.1; e. Revising S7.1 through S7.6 to read as set forth below; and f. Removing S8 through S8.4. The revisions and additions read as follows: § 571.216 Standard No. 216; Roof crush resistance. S3. *Application.* This standard applies to passenger cars, and to multipurpose passenger vehicles, trucks and buses with a GVWR of 4,536 kilograms (10,000 pounds) or less. However, it does not apply to—
(a)School buses;
(b)Vehicles that conform to the rollover test requirements (S5.3) of Standard No. 208 (§ 571.208) by means that require no action by vehicle occupants;
(c)*Convertibles* , except for optional compliance with the standard as an alternative to the rollover test requirement (S5.3) of Standard No. 208; or
(d)Vehicles manufactured in two or more stages, other than chassis cabs, that conform to the roof crush requirements
(S4)of Standard No. 220 (§ 571.220). S4. *Definitions.* *Convertible* means a vehicle whose A-pillars are not joined with the B-pillars (or rearmost pillars) by a fixed, rigid structural member. *Roof component* means the A-pillar, B-pillar, roof side rail, front header, rear header, roof, and all interior trim in contact with these components. S5. *Requirements.* When the test device described in S6 is used to apply a force to a vehicle's roof in accordance with S7, no roof component or portion of the test device may contact the head or the neck of the seated Hybrid III 50th percentile male dummy specified in 49 CFR Part 572, Subpart E. The maximum applied force in Newtons is any value up to and including 2.5 times the unloaded vehicle weight of the vehicle, measured in kilograms and multiplied by 9.8. A particular vehicle need not meet the requirements on the second side of the vehicle, after being tested at one location. S7.1 Secure the vehicle in accordance with S7.1(a) through (d).
(a)Support the vehicle off its suspension at a longitudinal vehicle attitude of 0 degrees ± 0.5 degrees. Measure the longitudinal vehicle attitude along both the driver and passenger sill. Determine the lateral vehicle attitude by measuring the vertical distance between a level surface and a standard reference point on the bottom of the driver and passenger side sills. The difference between the vertical distance measured on the driver side and the passenger side sills shall not exceed ± 1 cm.
(b)Secure the vehicle with four stands. The locations for supporting the vehicle are defined in S7.1(c) or (d). Welding is permissible. The vehicle overhangs are not supported. Chains and wire rope are not used to secure the vehicle. Fix all non-rigid body mounts to prevent motion of the body relative to the frame. Close all windows, close and lock all doors, and secure any moveable or removable roof structure in place over the occupant compartment. Remove roof racks or other non-structural components.
(c)For vehicles with manufacturer's designated jacking locations, locate the stands at or near the specified location.
(d)For vehicles with undefined jacking locations, generalized jacking areas, or jacking areas that are not part of the vehicle body or frame, such as axles or suspension members, locate two stands in the region forward of the rearmost axle and two stands rearward of the forwardmost axle. All four stands shall be located between the axles on either the vehicle body or vehicle frame. S7.2
(a)Adjust the seats and steering controls in accordance with S8.1.2 and S.8.1.4 of 49 CFR 571.208.
(b)Place adjustable seat backs in the manufacturer's nominal design riding position in the manner specified by the manufacturer. Place any adjustable anchorages at the manufacturer's nominal design position for a 50th percentile adult male occupant. Place each adjustable head restraint in its lowest adjustment position. Adjustable lumbar supports are positioned so that the lumbar support is in its lowest adjustment position. S7.3 Position the Hybrid III 50th percentile male dummy specified in 49 CFR Part 572, Subpart E in accordance with S10.1 through S10.6.2.2 of 49 CFR 571.208, in the front outboard designated seating position on the side of the vehicle being tested. S7.4 Orient the test device as shown in Figure 1 of this section, so that—
(a)Its longitudinal axis is at a forward angle (in side view) of 5 degrees below the horizontal, and is parallel to the vertical plane through the vehicle's longitudinal centerline;
(b)Its transverse axis is at an outboard angle, in the front view projection, of 25 degrees below the horizontal. S7.5 Maintaining the orientation specified in S7.4—
(a)Lower the test device until it initially makes contact with the roof of the vehicle.
(b)Position the test device so that—
(1)The longitudinal centerline on its lower surface is within 10 mm of the initial point of contact, or on the center of the initial contact area, with the roof; and
(2)The midpoint of the forward edge of the lower surface of the test device is within 10 mm of the transverse vertical plane 254 mm forward of the forwardmost point on the exterior surface of the roof, including windshield trim, that lies in the longitudinal vertical plane passing through the vehicle's longitudinal centerline. S7.6 Apply force so that the test device moves in a downward direction perpendicular to the lower surface of the test device at a rate of not more than 13 millimeters per second until reaching the force level specified in S5. Guide the test device so that throughout the test it moves, without rotation, in a straight line with its lower surface oriented as specified in S7.4(a) and S7.4(b). Complete the test within 120 seconds. Issued: January 24, 2008. Stephen R. Kratzke, Associate Administrator for Rulemaking. [FR Doc. 08-392 Filed 1-25-08; 12:22 pm]
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53 references not yet in our index
- 22 CFR 51
- 40 CFR 52
- 472 F.3d 882
- Pub. L. 104-4
- 40 CFR 180
- 40 CFR 178
- 40 CFR 152.112(g)
- 40 CFR 180.589(a)
- 40 CFR 180.589(d)
- 40 CFR 2
- 40 CFR 180.627
- 40 CFR 180.231
- Pub. L. 104-113
- 44 CFR 67
- 44 CFR 60
- 44 CFR 10
- 5 USC 601-612
- 45 CFR 1611
- 6 CFR 5
- Pub. L. 107-296
- 116 Stat. 2135
- 12 CFR 708
- 41 CFR 102
- 12 CFR 740
- 37 CFR 384
- Pub. L. 104-39
- Pub. L. 105-304
- Pub. L. 108-419
- 37 CFR 262
- 40 CFR 147
- 40 CFR 145
- 40 CFR 145.52
- 40 CFR 145.1(h)
- 40 CFR 144.8
- 40 CFR 147.1(e)
- 40 CFR 144.51
- 40 CFR 147.1
- 40 CFR 147.1(f)
- 450 U.S. 544
- 520 U.S. 438
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F. App'x472 F.3d 882
SCOTUS450 U.S. 544
SCOTUS520 U.S. 438
Cites 104 · showing 12Cited by 0 across 0 sources