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Code · REGISTER · 2006-08-25 · Environmental Protection Agency (EPA) · Notices

Notices. Final rule

24,958 words·~113 min read·/register/2006/08/25/06-7160

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

BILLING CODE 4910-15-M ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2006-0167; FRL-8088-8] Quinoxyfen; Pesticide Tolerance AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. SUMMARY: This regulation establishes tolerances for residues of quinoxyfen in or on commodities: lettuce, head and lettuce, leaf; melon, subgroup 9A; pepper, bell and pepper, nonbell; and strawberry. The Interregional Research Project Number 4 (IR-4) requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA).
DATES: This regulation is effective August 25, 2006. Objections and requests for hearings must be received on or before October 24, 2006, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION ). ADDRESSES: EPA has established a docket for this action under docket identification
(ID)number EPA-HQ-OPP-2006-0167. All documents in the docket are listed in the index for the docket. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information
(CBI)or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available in the electronic docket at *http://www.regulations.gov* , or, if only available in hard copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Building), 2777 S. Crystal Drive, Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket telephone number is
(703)305-5805. FOR FURTHER INFORMATION CONTACT: Sidney Jackson, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:
(703)305-7610; e-mail address: *jackson.sidney@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 111), e.g., agricultural workers; greenhouse, nursery, and floriculture workers; farmers. • Animal production (NAICS 112), e.g., cattle ranchers and farmers, dairy cattle farmers, livestock farmers. • Food manufacturing (NAICS 311), e.g., agricultural workers; farmers; greenhouse, nursery, and floriculture workers; ranchers; pesticide applicators. • Pesticide manufacturing (NAICS 32532), e.g., agricultural workers; commercial applicators; farmers; greenhouse, nursery, and floriculture workers; residential users. This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT . B. How Can I Access Electronic Copies of this Document? In addition to accessing an electronic copy of this **Federal Register** document through the electronic docket at *http://www.regulations.gov* , you may access this **Federal Register** document electronically through the EPA Internet under the “ **Federal Register** ” listings at *http://www.epa.gov/fedrgstr* . You may also access a frequently updated electronic version of 40 CFR part 180 through the Government Printing Office's pilot e-CFR site at *http://www.gpoaccess.gov/ecfr* . To access the OPPTS Harmonized Guidelines referenced in this document, go directly to the guidelines at *http://www.epa.gpo/opptsfrs/home/guidelin.htm* C. Can I File an Objection or Hearing Request? Under section 408(g) of the FFDCA, as amended by the FQPA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2006-0167 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before October 24, 2006. In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing that does not contain any CBI for inclusion in the public docket that is described in ADDRESSES . Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit your copies, identified by docket ID number EPA-HQ-OPP-2006-0167, 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 Building), 2777 S. Crystal Drive, 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 telephone number is
(703)305-5805. II. Background and Statutory Findings In the **Federal Register** of April 21, 2006 (71 FR 20667) (FRL-8056-4), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of pesticide petitions (PP 3E6755; 5E6969; and 5E6970) by the Interregional Research Project #4 (IR-4), 681 U.S. Highway #1 South, North Brunswick, NJ 08902-3390. The petitions requested that 40 CFR 180.588 be amended by establishing tolerances for residues of the fungicide quinoxyfen, (5,7-dichloro-4-(4-fluorophenoxy) quinoline in or on the raw agricultural commodities: eggplant at 1.0 parts per million
(ppm)(PP 3E6755); peppers (bell and non-bell) at 1.0 ppm (PP 3E6755); melon subgroup 9A at 0.1 ppm (PP 5E6969); lettuce, head and leaf at 17.0 ppm (PP 5E6970); and strawberry at 0.8 ppm (PP 5E6970). That notice included a summary of the petition prepared by Dow AgroSciences, the registrant. There were no comments received in response to the notice of filing. Upon completing review of the current quinoxyfen database, the Agency concluded that the appropriate tolerance levels for quinoxyfen residues in or on pending crops should be established as follow: Lettuce, head at 7.0 ppm; lettuce, leaf at 19 ppm; melon, subgroup 9A at 0.08 ppm; pepper, bell at 0.35 ppm; pepper, non-bell at 1.7 ppm; and strawberry at 0.90 ppm. The Agency concluded that there are insufficient data to establish a tolerance for quinoxyfen residues in or on eggplant, at this time. Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue....” EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. For further discussion of the regulatory requirements of section 408 of the FFDCA and a complete description of the risk assessment process, see *http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm* . III. Aggregate Risk Assessment and Determination of Safety Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure, consistent with section 408(b)(2) of FFDCA, for a tolerance for residues of quinoxyfen on lettuce, head at 7.0 ppm; lettuce, leaf at 19 ppm; melon (subgroup 9A) at 0.08 ppm; pepper, bell at 0.35 ppm; pepper, non-bell at 1.7 ppm; and strawberry at 0.90 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 their validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. Specific information on the studies received and the nature of the toxic effects caused by quinoxyfen 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 **Federal Register** of September 29, 2003 (68 FR 55858) (FRL-7318-2), under docket ID number EPA-HQ-OPP-2003-0218, to which the reader may refer for additional information. B. Toxicological Endpoints For hazards that have a threshold below which there is no appreciable risk, the dose at which no adverse effects are observed (the NOAEL) from the toxicology study identified as appropriate for use in risk assessment is used to estimate the toxicological level of concern (LOC). However, the lowest dose at which adverse effects of concern are identified (the LOAEL) is sometimes used for risk assessment if no NOAEL was achieved in the toxicology study selected. An uncertainty factor
(UF)is applied to reflect uncertainties inherent in the extrapolation from laboratory animal data to humans and in the variations in sensitivity among members of the human population as well as other unknowns. The linear default risk methodology (Q*) is the primary method currently used by the Agency to quantify non-threshold hazards such as cancer. The Q* approach assumes that any amount of exposure will lead to some degree of cancer risk, estimates risk in terms of the probability of occurrence of additional cancer cases. More information can be found on the general principles EPA uses in risk characterization at *http://www.epa.gov/pesticides/health/human.htm* . A summary of the toxicological endpoints for quinoxyfen used for human risk assessment is discussed in Unit III.B. of the final rule published in the **Federal Register** of September 29, 2003 (68 FR 55858) (FRL-7318-2), under docket ID number EPA-HQ-OPP-2003-0218, to which the reader may refer for additional information. C. Exposure Assessment 1. *Dietary exposure from food and feed uses* . Tolerances have been established (40 CFR 180.588) for the residues of quinoxyfen, in or on a variety of raw agricultural commodities. Permanent tolerances are established for residues of quinoxyfen *per se* in/on cherry, sweet and cherry, tart at 0.30 ppm; grape at 0.60 ppm; and dried hop cones at 3.0 ppm. In addition, time-limited tolerances are established under Section 18 emergency exemptions for residues of quinoxyfen per se in/on pumpkin; squash, winter; and vegetables, curcubit, subgroup 9A. Risk assessments were conducted by EPA to assess dietary exposures from quinoxyfen 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 one-day or single exposure. There were no toxic effects attributable to a single dose. Therefore, an endpoint of concern was not identified to quantitate acute-dietary risk to the general population or to the subpopulation females 13-50 years old. As a result, no acute risk is expected from exposure to quinoxyfen. ii. *Chronic exposure* . In conducting the chronic dietary exposure assessment EPA used the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM-FCID TM ), Version 2.03, which incorporates food consumption data as reported by respondents in the USDA 1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII), and accumulated exposure to the chemical for each commodity. The following assumptions were made for the chronic exposure assessments: An unrefined, Tier 1 chronic dietary (food and water) exposure assessment using tolerance-level residues and assuming 100% crops treated for all proposed commodities, and default DEEM Version 7.76 processing factors for all commodities. iii. *Cancer* . Quinoxyfen is classified as “not likely to be carcinogenic to humans,” based on the lack of evidence of carcinogenicity in rat and mice studies. Therefore, an exposure assessment for the purpose of evaluating cancer risk is not needed. 2. *Dietary exposure from drinking water* . The Agency lacks sufficient monitoring exposure data to complete a comprehensive dietary exposure analysis and risk assessment for quinoxyfen 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 physical characteristics of quinoxyfen. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at *http://www.epa.gov/oppefed1/models/water* . Typically EPA evaluates the potential for human exposure to pesticides in drinking water through an assessment of available surface water and ground water monitoring data and modeling. For quinoxyfen, no monitoring data were available for use in this drinking water assessment. Therefore, potential human exposures to quinoxyfen were evaluated through modeling. The Agency used the FQPA Index Reservoir Screening Tool (FIRST) to calculate the surface water Estimated Exposure Concentrations
(EECs)and the screening model SCI-GROW to calculate the groundwater EECs. The Agency considered residues of quinoxyfen per se, plus a metabolite, 3-OH quinoxyfen, in modeling studies. To do this, aerobic soil metabolism and aerobic aquatic metabolism half-lives determined for the parent compound in the guideline studies were recalculated using concentration data for the parent compound plus 3-OH quinoxyfen when the latter compound was present. Additionally, the Agency was restricted to the use of soil adsorption coefficients determined only for the parent compound; however, other available information from the guideline studies indicates that 3-OH quinoxyfen has mobility in soil similar to that of the parent compound. Because hydroxylation (the addition of the 3-OH) could increase its mobility relative to quinoxyfen, this metabolite has the potential to reach drinking water sources in significant quantities. For the surface water and groundwater assessments, EECs were determined using a maximum annual application rate for cherries of 0.55 lb a.i./A (five applications of 0.114 lb a.i./A/application). Based on the FIRST and SCI-GROW models, the estimated environmental concentrations
(EECs)of quinoxyfen for chronic exposures are estimated to be 0.84 ppb for surface water and 0.006 ppb for ground water. Model estimates of drinking water concentrations were directly entered into the dietary exposure model (DEEM-FCID). 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). Quinoxyfen is not registered for use on any sites that would result in residential exposure. 4. *Cumulative effects from substances with a common mechanism of toxicity* . Section 408(b)(2)(D)(v) of the 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 quinoxyfen and any other substances and quinoxyfen does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has not assumed that quinoxyfen has a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the policy statements released by EPA's Office of Pesticide Programs concerning common mechanism determinations and procedures for cumulating effects from substances found to have a common mechanism on EPA's website at *http://www.epa.gov/pesticides/cumulative* . D. Safety Factor for Infants and Children 1. *In general* . Section 408 of FFDCA provides that EPA shall apply an additional tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the data base on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. Margins of safety are incorporated into EPA risk assessments either directly through use of a MOE analysis or through using uncertainty (safety) factors in calculating a dose level that poses no appreciable risk to humans. In applying this provision, EPA either retains the default value of 10X when reliable data do not support the choice of a different factor, or, if reliable data are available, EPA uses a different additional safety factor value based on the use of traditional uncertainty factors and/or special FQPA safety factors, as appropriate. 2. *Prenatal and postnatal sensitivity* . There is no quantitative or qualitative evidence of increased susceptibility of rat and rabbit fetuses to in utero exposure in developmental studies. There is evidence of increased quantitative susceptibility (minimal decrease in F1a pup weights) in the rat multi-generation reproduction study, but the concern is low since:
(1)The effects in pups are well-characterized with a clear NOAEL;
(2)the pup effects are minimal at the LOAEL and only noted in the first-generation offspring; and
(3)the doses and endpoints selected for regulatory purposes would address the concerns of the pup effects noted in the rat reproduction study. Therefore, there are no residual uncertainties for prenatal/postnatal toxicity in this study. 3. *Conclusion* . There is a complete toxicity data base for quinoxyfen and exposure data are complete or are estimated based on data that reasonably account for potential exposures. There are no residual uncertainties for prenatal/postnatal toxicity. No additional safety factor is needed for data base uncertainties. No clinical sign of neurotoxicity or neuropathology was seen in the data base, including acute and subchronic neurotoxicity studies. A developmental neurotoxicity study is not required. Therefore, EPA determined that the 10X SF to protect infants and children should be reduced to 1X. E. Aggregate Risks and Determination of Safety 1. *Acute risk* . An endpoint of concern was not identified to quantitate acute-dietary risk to the general population or to the subpopulation females 13-50 years old. As a result, no acute risk is expected from exposure to quinoxyfen. 2. *Chronic risk* . Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to quinoxyfen from (food + water) will utilize 1.3% of the cPAD for the U.S. population, <1% of the cPAD for infants <1 year old), and 2.0% of the cPAD for children (1 to 2 years old) the subpopulation at greatest exposure. There are no residential uses for quinoxyfen that result in chronic residential exposure to quinoxyfen. 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). Quinoxyfen is not registered for use on any sites that would result in residential exposure. Therefore, the aggregate risk is the sum of the risk from food and water, which do not exceed 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). Quinoxyfen is not registered for use on any sites that would result in residential exposure. Therefore, the aggregate risk is the sum of the risk from food and water, which do not exceed the Agency's level of concern. 5. *Aggregate cancer risk for U.S. population* . Quinoxyfen has been classified as “not likely to be carcinogenic to humans.” Therefore, quinoxyfen is not expected to pose a cancer risk. 6. *Determination of safety* . Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, and to infants and children from aggregate exposure to quinoxyfen residues. IV. Other Considerations A. Analytical Enforcement Methodology A practical analytical method is available to monitor and enforce the tolerances of quinoxyfen residues in crops. The analytical method uses capillary gas chromatography and mass spectrometry detector (GC-MSD) with limits of quantitation
(LOQ)of approximately 0.01 ppm. The method is adequate for collecting data and enforcing tolerances for quinoxyfen residues in/on the subject crops. There are no livestock feed items associated with these petitions, therefore, data collection and tolerance enforcement methods for livestock commodities are not required. B. International Residue Limits There are no Mexican, Canadian or Codex maximum residue limits
(MRLs)established for quinoxyfen in/on crops considered in this action. Therefore, no compatibility issues exist for these tolerances. V. Conclusion Therefore, the tolerance is established for residues of quinoxyfen, 5,7-dichloro-4-(4-fluorophenoxy) quinoline in or on lettuce, head at 7.0 ppm and lettuce, leaf at 19 ppm; melon, subgroup 9A at 0.08 ppm; pepper, bell at 0.35 ppm; pepper, nonbell at 1.7 ppm; and strawberry at 0.90 ppm. . VI. Statutory and Executive Order Reviews This final rule establishes a tolerance under section 408(d) of FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget
(OMB)has exempted these types of actions from review under Executive Order 12866, entitled *Regulatory Planning and Review* (58 FR 51735, October 4, 1993). Because this rule has been exempted from review under Executive Order 12866 due to its lack of significance, this rule is not subject to Executive Order 13211, *Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use* (66 FR 28355, May 22, 2001). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 *et seq.* , or impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995
(UMRA)(Public Law 104-4). Nor does it require any special considerations under Executive Order 12898, entitled *Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations* (59 FR 7629, February 16, 1994); or OMB review or any Agency action under Executive Order 13045, entitled *Protection of Children from Environmental Health Risks and Safety Risks* (62 FR 19885, April 23, 1997). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since tolerances and exemptions that are established on the basis of a petition under section 408(d) of FFDCA, such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act
(RFA)(5 U.S.C. 601 *et seq.* ) do not apply. In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled *Federalism* (64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive order to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” This final rule directly regulates growers, food processors, food handlers and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. For these same reasons, the Agency has determined that this rule does not have any “tribal implications” as described in Executive Order 13175, entitled *Consultation and Coordination with Indian Tribal Governments* (65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” “Policies that have tribal implications” is defined in the Executive order to include regulations that have “substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.” This rule will not have substantial direct effects on tribal governments, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule. VII. Congressional Review Act The Congressional Review Act, 5 U.S.C. 801 *et seq.* , as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of this final rule in the **Federal Register** . This final rule is not a “major rule” as defined by 5 U.S.C. 804(2). List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: August 16, 2006. Lois Rossi, Director, Registration Division, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: PART 180—[AMENDED] 1. The authority citation for part 180 continues to read as follows: Authority: 21 U.S.C. 321(q), 346a and 371. 2. Section 180.588 is amended by alphabetically adding commodities to the table in paragraph
(a)to read as follows: § 180.588 Quinoxyfen; tolerances for residues.
(a)* * * Commodity Parts per million * * * * * Lettuce, head 7.0 Lettuce, leaf 19 Melon, subgroup 9A 0.08 Pepper, bell 0.35 Pepper, nonbell 1.7 Strawberry 0.90 [FR Doc. E6-14065 Filed 8-24-06; 8:45 am] BILLING CODE 6560-50-S ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2006-0333; FRL-8088-1] Kresoxim-methyl; Pesticide Tolerance AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. SUMMARY: This regulation establishes a tolerance for combined residues of kresoxim-methyl in or on vegetable, cucurbit, group 9. Interregional Research Project No. 4 requested this tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA). DATES: This regulation is effective August 25, 2006. Objections and requests for hearings must be received on or before October 24, 2006, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION ). ADDRESSES: EPA has established a docket for this action under docket identification
(ID)number EPA-HQ-OPP-2006-0333. All documents in the docket are listed in the index for the docket. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information
(CBI)or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available in the electronic docket at *http://www.regulations.gov* , or, if only available in hard copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Building), 2777 S. Crystal Drive, Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket telephone number is
(703)305-5805. FOR FURTHER INFORMATION CONTACT: Barbara Madden, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:
(703)305-6463; e-mail address: *madden.barbara@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 111), e.g., agricultural workers; greenhouse, nursery, and floriculture workers; farmers. • Animal production (NAICS 112), e.g., cattle ranchers and farmers, dairy cattle farmers, livestock farmers. • Food manufacturing (NAICS 311), e.g., agricultural workers; farmers; greenhouse, nursery, and floriculture workers; ranchers; pesticide applicators. • Pesticide manufacturing (NAICS 32532), e.g., agricultural workers; commercial applicators; farmers; greenhouse, nursery, and floriculture workers; residential users. This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT . B. How Can I Access Electronic Copies of this Document? In addition to accessing an electronic copy of this **Federal Register** document through the electronic docket at *http://www.regulations.gov* , you may access this **Federal Register** document electronically through the EPA Internet under the “ **Federal Register** ” listings at *http://www.epa.gov/fedrgstr* . You may also access a frequently updated electronic version of 40 CFR part 180 through the Government Printing Office's pilot e-CFR site at *http://www.gpoaccess.gov/ecfr* . To access the OPPTS Harmonized Guidelines referenced in this document, go directly to the guidelines at *http://www.epa.gpo/opptsfrs/home/guidelin.htm* C. Can I File an Objection or Hearing Request? Under section 408(g) of the FFDCA, as amended by the FQPA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2006-0333 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before October 24, 2006. In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing that does not contain any CBI for inclusion in the public docket that is described in ADDRESSES . Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit your copies, identified by docket ID number EPA-HQ-OPP-2006-0333, 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 Building), 2777 S. Crystal Drive, 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 telephone number is
(703)305-5805. II. Background and Statutory Findings In the **Federal Register** of June 7, 2006 (71 FR 32950) (FRL-8068-1), 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 3E6594) by Interregional Research Project No. 4, Rutgers, the State University of New Jersey, 681 U.S. Highway No. 1, South Brunswick, NJ 08902-3390. The petition requested that 40 CFR 180.554 be amended by establishing a tolerance for combined residues of the fungicide kresoxim-methyl (methyl (E)-2-[2-(2-methylphenoxy)-methyl]phenyl-2-(methoxyimido)acetate) and its metabolites as follows: (E)-2-[2-(2-methylphenoxy)methyl]-phenyl-2-(methoxyimido)acetic acid; (E)-2-[2-(2-hydroxymethylphenoxy)methyl]-phenyl-2-(methoxyimido)acetic acid (free and glucose conjugated); and (E)-2-[2-(4-hydroxy-2-methylphenoxy)-methyl]phenyl-2-(methoxyimido)acetic acid (free and glucose conjugated), in or on vegetable, cucurbit, group 9 at 0.5 parts per million (ppm). That notice included a summary of the petition prepared by BASF Corporation, the registrant. There were no comments received in response to the notice of filing. Petition (PP 3E6594) was subsequently amended to lower the residue level for vegetable, cucurbit, group 9 to 0.40 ppm. Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue....” EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. For further discussion of the regulatory requirements of section 408 of the FFDCA and a complete description of the risk assessment process, see *http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm* . III. Aggregate Risk Assessment and Determination of Safety Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure, consistent with section 408(b)(2) of FFDCA, for a tolerance for combined residues of kresoxim-methyl on vegetable, cucurbit, group 9 at 0.40 ppm. EPA's assessment of exposures and risks associated with establishing the tolerance follows. A. Toxicological Profile EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. Specific information on the studies received and the nature of the toxic effects caused by kresoxim-methyl as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found at *http://www.epa.gov/EPA-PEST/1999/June/Day-10/p14761.htm.* B. Toxicological Endpoints For hazards that have a threshold below which there is no appreciable risk, the dose at which no adverse effects are observed (the NOAEL) from the toxicology study identified as appropriate for use in risk assessment is used to estimate the toxicological level of concern (LOC). However, the lowest dose at which adverse effects of concern are identified (the LOAEL) is sometimes used for risk assessment if no NOAEL was achieved in the toxicology study selected. An uncertainty factor
(UF)is applied to reflect uncertainties inherent in the extrapolation from laboratory animal data to humans and in the variations in sensitivity among members of the human population as well as other unknowns. The linear default risk methodology (Q*) is the primary method currently used by the Agency to quantify non-threshold hazards such as cancer. The Q* approach assumes that any amount of exposure will lead to some degree of cancer risk, estimates risk in terms of the probability of occurrence of additional cancer cases. More information can be found on the general principles EPA uses in risk characterization at *http://www.epa.gov/pesticides/health/human.htm* . A summary of the toxicological endpoints for kresoxim-methyl used for human risk assessment is discussed in Unit III.B. of the final rule published in the **Federal Register** of June 10, 1999 (64 FR 31129) (FRL-6085-4) *http://www.epa.gov/EPA-PEST/1999/June/Day-10/p14761.htm* . C. Exposure Assessment 1. *Dietary exposure from food and feed uses* . Tolerances have been established (40 CFR 180.554) for the combined residues of kresoxim-methyl, in or on a variety of raw agricultural commodities. In addition, tolerances have been established for the residues of the kresoxim-methyl metabolite (E)-2-[2-(2-methylphenoxy)methyl]-phenyl-2-(methoxyimido)acetic acid in meat byproducts of cattle, goat, and sheep. Risk assessments were conducted by EPA to assess dietary exposures from kresoxim-methyl 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 one-day or single exposure. No such effects were identified in the toxicological studies for kresoxim-methyl; therefore, a quantitative acute dietary exposure assessment is unnecessary. ii. *Chronic exposure* . In conducting the chronic dietary exposure assessment EPA used the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM-FCID TM ), which incorporates food consumption data as reported by respondents in the USDA 1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII), and accumulated exposure to the chemical for each commodity. The following assumptions were made for the chronic exposure assessments: A partially-refined, Tier 3 chronic dietary risk assessment incorporated average field-trial residues for all food commodities, available processing data for grapes, apples, and screening-level percent crop treated
(PCT)data for most of the registered commodities. iii. *Cancer* . In conducting the cancer dietary exposure assessment EPA used the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM-FCID TM ), which incorporates food consumption data as reported by respondents in the USDA 1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII), and accumulated exposure to the chemical for each commodity. The following assumptions were made for the cancer exposure assessment: A partially-refined, Tier 3 cancer dietary risk assessment incorporated average field-trial residues for all food commodities, available processing data for grapes, apples, and screening-level percent crop treated
(PCT)data for most of the registered commodities. iv. *Anticipated residue and percent crop treated
(PCT)information* . Section 408(b)(2)(E) of the FFDCA authorizes EPA to use available data and information on the anticipated residue levels of pesticide residues in food and the actual levels of pesticide chemicals that have been measured in food. If EPA relies on such information, EPA must pursuant to section 408(f)(1) require that data be provided 5 years after the tolerance is established, modified, or left in effect, demonstrating that the levels in food are not above the levels anticipated. Following the initial data submission, EPA is authorized to require similar data on a time frame it deems appropriate. For the present action, EPA will issue such data call-ins for information relating to anticipated residues as are required by FFDCA section 408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Such data call-ins will be required to be submitted no later than 5 years from the date of issuance of this tolerance. Section 408(b)(2)(F) of FFDCA states that the Agency may use data on the actual percent of food treated for assessing chronic dietary risk only if the Agency can make the following findings: Condition 1, that the data used are reliable and provide a valid basis to show what percentage of the food derived from such crop is likely to contain such pesticide residue; Condition 2, that the exposure estimate does not underestimate exposure for any significant subpopulation group; and Condition 3, if data are available on pesticide use and food consumption in a particular area, the exposure estimate does not understate exposure for the population in such area. In addition, the Agency must provide for periodic evaluation of any estimates used. To provide for the periodic evaluation of the estimate of PCT as required by section 408(b)(2)(F) of FFDCA, EPA may require registrants to submit data on PCT. The Agency used PCT information as follows: Apple, 10%; grape, 5%; pear, 5%; and pecan, 1%. EPA uses an average PCT for chronic dietary risk analysis. The average PCT figure for each existing use is derived by combining available Federal, state, and private market survey data for that use, averaging by year, averaging across all years, and rounding up to the nearest multiple of five percent except for those situations in which the average PCT is less than one. In those cases <1% is used as the average and <2.5% is used as the maximum. EPA uses a maximum PCT for acute dietary risk analysis. The maximum PCT figure is the single maximum value reported overall from available Federal, state, and private market survey data on the existing use, across all years, and rounded up to the nearest multiple of five percent. In most cases, EPA uses available data from United States Department of Agriculture/National Agricultural Statistics Service (USDA/NASS), Proprietary Market Surveys, and the National Center for Food and Agriculture Policy (NCFAP) for the most recent 6 years. This method of projecting PCT for a new pesticide, with or without regard to specific pest(s), produces an upper-end projection that is unlikely, in most cases, to be exceeded in actuality in the next 5 years because one or more of the following conditions will likely apply: the dominant pesticide is better established and accepted by farmers than the new pesticide, the dominant pesticide is more efficacious than the new pesticide, the dominant pesticide controls a broader spectrum and/or more important pests than the new pesticide, the dominant pesticide is more cost-effective than the new pesticide, and other conditions. 2. *Dietary exposure from drinking water* . The Agency lacks sufficient monitoring exposure data to complete a comprehensive dietary exposure analysis and risk assessment for kresoxim-methyl 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 physical characteristics of kresoxim-methyl. 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* . Estimated drinking water concentrations (EDWCs) were calculated for both kresoxim-methyl and (E)-2-[2-(2-methylphenoxy)methyl]-phenyl-2-(methoxyimido)acetic acid. Based on the PRZM/EXAMS and SCI-GROW models, the estimated environmental concentrations
(EECs)of kresoxim-methyl for chronic exposures are estimated to be 14.91 parts per billion
(ppb)for surface water and 6.27 ppb for ground water. The EECs for cancer chronic exposures are estimated to be 7.88 ppb for surface water and 6.27 ppb for ground water. Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model (DEEM-FCID TM ). Since the surface water EDWCs are higher than the ground water EDWC, the Agency selected these values for use in the dietary assessment. The 1-in-10 year mean of 14.91 ppb was used for the chronic (non-cancer) analysis, and the 30-year mean of 7.88 ppb was used for the cancer analysis. 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). Kresoxim-methyl is not registered for use on any sites that would result in residential exposure. 4. *Cumulative effects from substances with a common mechanism of toxicity* . Section 408(b)(2)(D)(v) of the 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 kresoxim-methyl and any other substances and kresoxim-methyl does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has not assumed that kresoxim-methyl has a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the policy statements released by EPA's Office of Pesticide Programs concerning common mechanism determinations and procedures for cumulating effects from substances found to have a common mechanism on EPA's website at *http://www.epa.gov/pesticides/cumulative.* Section 408(b)(2)(D)(v) of the 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.” D. Safety Factor for Infants and Children 1. *In general* . Section 408 of FFDCA provides that EPA shall apply an additional tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity, and the completeness of the data base on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. Margins of safety are incorporated into EPA risk assessments either directly through use of a MOE analysis or through using uncertainty (safety) factors in calculating a dose level that poses no appreciable risk to humans. In applying this provision, EPA either retains the default value of 10X when reliable data do not support the choice of a different factor, or, if reliable data are available, EPA uses a different additional safety factor value based on the use of traditional uncertainty factors and/or special FQPA safety factors, as appropriate. 2. *Prenatal and postnatal sensitivity* . In the prenatal developmental toxicity studies in rat and rabbit fetuses, no evidence of developmental toxicity in fetuses was seen at the limit dose. In the 2-generation reproduction study in rats, offspring effects occurred only at parentally toxic dose levels. 3. *Conclusion* . There is a complete toxicity data base for kresoxim-methyl and exposure data are complete or are estimated based on data that reasonably accounts for potential exposures. Taking into account the lack of any special pre- or post-natal susceptibility and the completeness of the toxicity and exposure data base, EPA determined that the 10X SF to protect infants and children should be reduced to 1X. E. Aggregate Risks and Determination of Safety 1. *Acute risk.* An acute risk assessment was not performed. No toxicological endpoint attributable to a single (acute) dietary exposure was identified. Therefore, acute risk from exposure to kresoxim-methyl is not expected. 2. *Chronic risk* . Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to kresoxim-methyl from food and water will utilize <1 % of the cPAD for the U.S. population and all subpopulations including all infants <1 year old, the subpopulation at greatest exposure. There are no residential uses for kresoxim-methyl. Therefore, EPA does not expect the aggregate exposure to exceed 100% of the cPAD. 3. *Short-and intermediate term risk* . Short- and intermediate-term aggregate exposure takes into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Kresoxim-methyl is not registered for use on any sites that would result in residential exposure. Therefore, the aggregate risk is the sum of the risk from food and water, which do not exceed the Agency's level of concern. 4. *Aggregate cancer risk for U.S. population* . Using the exposure assumptions described in this unit for cancer exposure, EPA has concluded that the estimated exposure of the general U.S. population to kresoxim-methyl is 0.000234 mg/kg/day. Applying the Q1* of 0.0029 (mg/kg/day) -1 to the exposure value results in a lifetime cancer risk estimate of 6.80 x 10 -7 . The EPA considers cancer risk estimates between 1 x 10 -6 and 3 x 10 -6 to fall within the acceptable range of cancer risk (i.e., less than the range of 10 -6 ); therefore, the cancer risk estimate for kresoxim-methyl is below the Agency's level of concern. 5. *Determination of safety* . Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, and to infants and children from aggregate exposure to kresoxim-methyl residues. IV. Other Considerations A. Analytical Enforcement Methodology Adequate enforcement methodology (BASF Methods 350/3-US and D9611A are high-performance liquid chromatography (HPLC)/column-switching methods with ultraviolet
(UV)detection (270 nm)) are 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 Codex has established maximum residue limits
(MRLs)for kresoxim-methyl on various crop commodities. The Codex residue definitions for kresoxim-methyl in plant commodities are in terms of the parent only, and a Codex MRL is established for cucumber at 0.05 ppm. The U.S. and Codex tolerances/MRLs are not compatible with regard to tolerance expression and therefore, the levels can not be harmonized as the recommended tolerance (0.40 ppm) is significantly higher than the Codex MRL (0.05 ppm). V. Conclusion Therefore, the tolerance is established for combined residues of kresoxim-methyl (methyl (E)-2-[2-(2-methylphenoxy)-methyl]phenyl-2-(methoxyimido)acetate) and its metabolites as follows: (E)-2-[2-(2-methylphenoxy)methyl]-phenyl-2-(methoxyimido)acetic acid; (E)-2-[2-(2-hydroxymethylphenoxy)methyl]-phenyl-2-(methoxyimido)acetic acid (free and glucose conjugated); and (E)-2-[2-(4-hydroxy-2-methylphenoxy)-methyl]phenyl-2-(methoxyimido)acetic acid (free and glucose conjugated), in or on vegetable, cucurbit, group 9 at 0.40 ppm. VI. Statutory and Executive Order Reviews This final rule establishes a tolerance under section 408(d) of FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget
(OMB)has exempted these types of actions from review under Executive Order 12866, entitled *Regulatory Planning and Review* (58 FR 51735, October 4, 1993). Because this rule has been exempted from review under Executive Order 12866 due to its lack of significance, this rule is not subject to Executive Order 13211, *Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use* (66 FR 28355, May 22, 2001). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 *et seq.* , or impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995
(UMRA)(Public Law 104-4). Nor does it require any special considerations under Executive Order 12898, entitled *Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations* (59 FR 7629, February 16, 1994); or OMB review or any Agency action under Executive Order 13045, entitled *Protection of Children from Environmental Health Risks and Safety Risks* (62 FR 19885, April 23, 1997). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since tolerances and exemptions that are established on the basis of a petition under section 408(d) of FFDCA, such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act
(RFA)(5 U.S.C. 601 *et seq.* ) do not apply. In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled *Federalism* (64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive order to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” This final rule directly regulates growers, food processors, food handlers and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. For these same reasons, the Agency has determined that this rule does not have any “tribal implications” as described in Executive Order 13175, entitled *Consultation and Coordination with Indian Tribal Governments* (65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” “Policies that have tribal implications” is defined in the Executive order to include regulations that have “substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.” This rule will not have substantial direct effects on tribal governments, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule. VII. Congressional Review Act The Congressional Review Act, 5 U.S.C. 801 *et seq.* , as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of this final rule in the **Federal Register** . This final rule is not a “major rule” as defined by 5 U.S.C. 804(2). List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: August 16, 2006. Lois Rossi, Director, Registration Division, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: PART 180—[AMENDED] 1. The authority citation for part 180 continues to read as follows: Authority: 21 U.S.C. 321(q), 346a and 371. 2. Section 180.554 is amended by alphabetically adding a commodity to the table in paragraph (a)(1) to read as follows: § 180.554 Kresoxim-methyl; tolerances for residues.
(a)*General* .
(1)* * * Commodity Parts per million * * * * * Vegetable, cucurbit, group 9 0.40 [FR Doc. E6-14165 Filed 8-24-06; 8:45 am] BILLING CODE 6560-50-S DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency 44 CFR Part 64 [Docket No. FEMA-7941] Suspension of Community Eligibility AGENCY: Mitigation Division, Federal Emergency Management Agency (FEMA), Department of Homeland Security. ACTION: Final rule. SUMMARY: This rule identifies communities, where the sale of flood insurance has been authorized under the National Flood Insurance Program (NFIP), that are scheduled for suspension on the effective dates listed within this rule because of noncompliance with the floodplain management requirements of the program. If FEMA receives documentation that the community has adopted the required floodplain management measures prior to the effective suspension date given in this rule, the suspension will not occur and a notice of this will be provided by publication in the **Federal Register** on a subsequent date. DATES: *Effective Dates:* The effective date of each community's scheduled suspension is the third date (“Susp.”) listed in the third column of the following tables. ADDRESSES: If you want to determine whether a particular community was suspended on the suspension date, contact the appropriate FEMA Regional Office. FOR FURTHER INFORMATION CONTACT: David Stearrett, Mitigation Division, 500 C Street, SW., Washington, DC 20472,
(202)646-2953. SUPPLEMENTARY INFORMATION: The NFIP enables property owners to purchase flood insurance which is generally not otherwise available. In return, communities agree to adopt and administer local floodplain management aimed at protecting lives and new construction from future flooding. Section 1315 of the National Flood Insurance Act of 1968, as amended, 42 U.S.C. 4022, prohibits flood insurance coverage as authorized under the NFIP, 42 U.S.C. 4001 *et seq.* ; unless an appropriate public body adopts adequate floodplain management measures with effective enforcement measures. The communities listed in this document no longer meet that statutory requirement for compliance with program regulations, 44 CFR part 59 *et seq.* Accordingly, the communities will be suspended on the effective date in the third column. As of that date, flood insurance will no longer be available in the community. However, some of these communities may adopt and submit the required documentation of legally enforceable floodplain management measures after this rule is published but prior to the actual suspension date. These communities will not be suspended and will continue their eligibility for the sale of insurance. A notice withdrawing the suspension of the communities will be published in the **Federal Register** . In addition, FEMA has identified the Special Flood Hazard Areas (SFHAs) in these communities by publishing a Flood Insurance Rate Map (FIRM). The date of the FIRM, if one has been published, is indicated in the fourth column of the table. No direct Federal financial assistance (except assistance pursuant to the Robert T. Stafford Disaster Relief and Emergency Assistance Act not in connection with a flood) may legally be provided for construction or acquisition of buildings in identified SFHAs for communities not participating in the NFIP and identified for more than a year, on FEMA's initial flood insurance map of the community as having flood-prone areas (section 202(a) of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4106(a), as amended). This prohibition against certain types of Federal assistance becomes effective for the communities listed on the date shown in the last column. The Administrator finds that notice and public comment under 5 U.S.C. 553(b) are impracticable and unnecessary because communities listed in this final rule have been adequately notified. Each community receives 6-month, 90-day, and 30-day notification letters addressed to the Chief Executive Officer stating that the community will be suspended unless the required floodplain management measures are met prior to the effective suspension date. Since these notifications were made, this final rule may take effect within less than 30 days. *National Environmental Policy Act.* This rule is categorically excluded from the requirements of 44 CFR part 10, Environmental Considerations. No environmental impact assessment has been prepared. *Regulatory Flexibility Act.* The Administrator has determined that this rule is exempt from the requirements of the Regulatory Flexibility Act because the National Flood Insurance Act of 1968, as amended, 42 U.S.C. 4022, prohibits flood insurance coverage unless an appropriate public body adopts adequate floodplain management measures with effective enforcement measures. The communities listed no longer comply with the statutory requirements, and after the effective date, flood insurance will no longer be available in the communities unless remedial action takes place. *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 rule involves no policies that have federalism implications under Executive Order 13132. *Executive Order 12988, Civil Justice Reform.* This rule meets the applicable standards of Executive Order 12988. *Paperwork Reduction Act.* This rule does not involve any collection of information for purposes of the Paperwork Reduction Act, 44 U.S.C. 3501 *et seq.* List of Subjects in 44 CFR Part 64 Flood insurance, Floodplains. Accordingly, 44 CFR part 64 is amended as follows: PART 64—[AMENDED] 1. The authority citation for part 64 is revised 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. § 64.6 [Amended] The tables published under the authority of § 64.6 are amended as follows: State and location Community No. Effective date authorization/cancellation of sale of flood insurance in community Current effective map date Date certain Federal assistance no longer available in SFHAs Region IV Georgia: Glynn County, Unincorporated Areas 130092 January 16, 1974, Emerg; April 15, 1985, Reg; September 6, 2006, Susp 09/06/2006 09/06/2006. Jekyll Island, State Park Authority, Glynn County 130201 February 25, 1974, Emerg; June 1, 1984, Reg; September 6, 2006, Susp ......do* Do. North Carolina: Alamance, Village of, Alamance County 370457 December 17, 1987, Emerg; December 17, 1987, Reg; September 6, 2006, Susp ......do Do. Almance County, Unincorporated Areas 370001 January 16, 1975, Emerg; December 1, 1981, Reg; September 6, 2006, Susp ......do Do. Burlington, City of, Alamance County 370002 April 18, 1975, Emerg; April 1, 1981, Reg; September 6, 2006, Susp ......do Do. Elon College, Town of, Alamance County 370411 March 10, 1988, June 5, 1989, Reg; September 6, 2006, Susp ......do Do. Gibsonville, Town of, Alamance County 370387 June 23, 1975, Emerg; May 15, 1980, Reg; September 6, 2006, Susp ......do Do. Graham, City of, Alamance County 370283 June 30, 1976, Emerg; November 19, 1980, Reg; September 6, 2006, Susp ......do Do. Haw River, Town of, Alamance County 370003 August 25, 1975, Emerg; November 5, 1980, Reg; September 6, 2006, Susp ......do Do. Lee County, Unincorporated Areas 370331 October 4, 1978, Emerg; September 6, 1989, Reg; September 6, 2006, Susp ......do Do. Mebane, City of, Alamance County 370390 September 26, 1975, Emerg; November 5, 1980, Reg; September 6, 2006, Susp ......do Do. Sanford, City of, Lee County 370143 June 26, 1978, Emerg; September 6, 1989, Reg; September 6, 2006, Susp ......do Do. Swepsonville, Town of, Alamance County 370073 July 31, 2001, Emerg; July 31, 2001, Reg; September 6, 2006, Susp ......do Do. Region V Illinois: Cherry Valley, Village of, Winnebago County 170721 February 18, 1975, Emerg; March 16, 1981, Emerg; September 6, 2006, Susp ......do Do. Durand, Village of, Winnebago County 170789 June 25, 1975, Emerg; September 2, 1981, Emerg; September 6, 2006, Susp ......do Do. Loves Park, City of, Winnebago County 170722 February 23, 1973, Emerg; October 17, 1978, Emerg; September 6, 2006, Susp ......do Do. Machesney Park, Village of, Winnebago County 171009 September 30, 1981, Emerg; September 30, 1981, Reg; September 6, 2006, Susp ......do Do. Pecatonica, Village of, Winnebago County 170797 July 14, 1978, Emerg; December 1, 1981, Reg; September 6, 2006, Susp ......do Do. Rockford, City of, Winnebago County 170723 February 9, 1973, Emerg; December 4, 1979, Reg; September 6, 2006, Susp ......do Do. Rockton, Village of, Winnebago County 170774 July 7, 1975, Emerg; October 15, 1981, Reg; September 6, 2006, Susp ......do Do. Roscoe, Village of, Winnebago County 170724 June 11, 1974, Emerg; March 1, 1982, Reg; September 6, 2006, Susp ......do Do. Winnebago County, Unincorporated Areas 170720 February 16, 1973, Emerg; November 19, 1980, Reg; September 6, 2006, Susp ......do Do. Region IX California: Healdsburg, City of, Sonoma County 060378 May 20, 1974, Emerg; March 4, 1980, Reg; September 6, 2006, Susp ......do Do. Sonoma County, Unincorporated Areas 060375 August 27, 1971, Emerg; January 20, 1982, Reg; September 6, 2006, Susp ......do Do. * -do- = Ditto. Code for reading third column: Emerg.—Emergency; Reg.—Regular; Susp.—Suspension. Dated: August 17, 2006. David I. Maurstad, Mitigation Division Director, Federal Emergency Management Agency, Department of Homeland Security. [FR Doc. E6-14141 Filed 8-24-06; 8:45 am] BILLING CODE 9110-12-P DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Parts 222 and 223 [Docket No. 050315074-6117-02; I.D. 022405B] RIN 0648-AS92 Endangered and Threatened Wildlife; Sea Turtle Conservation AGENCY: National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce. ACTION: Final rule. SUMMARY: NMFS issues this final rule to require sea turtle conservation measures for all sea scallop dredge vessels fishing south of 41° 9.0′ N. latitude from May 1 through November 30 each year. All vessels with a sea scallop dredge and that are required to have a Federal Atlantic sea scallop fishery permit, regardless of dredge size or vessel permit category, must modify their dredge(s) when fishing south of 41° 9.0′ N. latitude, from the shoreline to the outer boundary of the Exclusive Economic Zone (EEZ). This action is necessary to help reduce mortality and injury to endangered and threatened sea turtles in scallop dredge gear and to conserve sea turtles listed under the Endangered Species Act (ESA). Any incidental take of threatened sea turtles in sea scallop dredge gear in compliance with this gear modification requirement and all other applicable requirements will be exempted on the ESA's prohibition against takes. DATES: Effective September 25, 2006. ADDRESSES: Copies of the Environmental Assessment
(EA)and Regulatory Impact Review/Final Regulatory Flexibility Analysis (RIR/FRFA) prepared for this final rule may be obtained by writing to Ellen Keane, NMFS, Northeast Region, One Blackburn Drive, Gloucester, MA 01930. FOR FURTHER INFORMATION CONTACT: Ellen Keane (ph. 978-281-9300 x6526, fax 978-281-9394, email *ellen.keane@noaa.gov* ) or Barbara Schroeder (ph. 301-713-1401, fax 301-713-0376, email *barbara.schroeder@noaa.gov* ). SUPPLEMENTARY INFORMATION: Background All sea turtles that occur in U.S. waters are listed as either endangered or threatened under the Endangered Species Act of 1973 (ESA). The Kemp's ridley ( *Lepidochelys kempii* ), leatherback ( *Dermochelys coriacea* ), and hawksbill ( *Eretmochelys imbricata* ) sea turtles are listed as endangered. The loggerhead ( *Caretta caretta* ) and green ( *Chelonia mydas* ) sea turtles are listed as threatened, except for breeding populations of green turtles in Florida and on the Pacific coast of Mexico that are listed as endangered. Due to the inability to distinguish between these populations of green turtles away from the nesting beach, NMFS considers green sea turtles endangered wherever they occur in U.S. waters. Kemp's ridley, hawksbill, loggerhead, and green sea turtles are hard-shelled sea turtles. The incidental take, both lethal and non-lethal, of loggerhead and unidentified hard-shelled sea turtles as a result of scallop dredging has been documented in the sea scallop dredge fishery. In addition, non-lethal takes of a green and a Kemp's ridley sea turtle have been documented in this fishery. This action, taken under the authority of section 4(d) of the ESA, is necessary to provide for the conservation of threatened loggerhead sea turtles, and will have ancillary benefits for Kemp's ridley and green sea turtles, which have been observed taken in the sea scallop dredge fishery, albeit to a lesser extent than loggerheads. Under the ESA and its implementing regulations, taking endangered sea turtles - even incidentally - is prohibited. The incidental take of endangered species may only legally be exempted by an incidental take statement or an incidental take permit issued pursuant to section 7 or 10 the ESA, respectively. Existing sea turtle conservation regulations at 50 CFR 223.206(d) exempt fishing activities and scientific research from the prohibition on takes of threatened species under certain conditions. Any incidental take of threatened loggerhead sea turtles in sea scallop dredge gear in compliance with this gear modification requirement and other applicable requirements is exempted from the prohibition against takes. Additional background information for this action is included in the preamble to the proposed rule (70 FR 30660, May 27, 2005). Based on the available information, NMFS has determined that the use of a dredge modified with a chain mat will prevent most, if not all, captures of sea turtles in the dredge bag as well as any ensuing injuries as a result of being caught in the dredge (e.g., crushing in the dredge bag, crushing on deck, etc.). In addition, it is possible that this action may reduce drowning due to forced submergence following an interaction with sea scallop dredge gear on the seafloor. Sea turtles observed captured in the scallop dredge fishery in 2003 ranged in size from 55 107 cm (21.6 - 42.1 inches) from notch to tip (curved carapace length). When converted to straight carapace length
(SCL)based on the formula for loggerheads provided in Teas (1993), the size range of the loggerhead sea turtles observed captured in the fishery in 2003 is 51-100 cm (20.1 - 39.4 inches). NMFS reviewed size at stage data for Atlantic loggerheads. Depending on the dataset used, the cutoff between pelagic immature and benthic immature loggerhead sea turtles was 42-49 cm (16.5 - 19.3 inches) SCL, and the cutoff between benthic immature and sexually mature loggerhead sea turtles was described as 83 90 cm (32.7 - 35.4 inches) SCL (NMFS SEFSC, 2001). Other authors define the benthic immature stage for loggerheads as 36 100 cm (14.2 - 39.4 inches) (Bass *et al.* , 2004). Based on these datasets and observer measurements of loggerhead sea turtles captured in the sea scallop dredge fishery, NMFS anticipates that both benthic immature and sexually mature loggerhead sea turtles are captured in this fishery. NMFS recognizes that, on rare occasions, sea turtles that interact with the modified gear may be small enough to enter the dredge bag, and that this interaction may result in the capture of the sea turtle in the bag. However, NMFS expects this to be a rare occurrence based on the life history of loggerhead sea turtles and the observer measurements. This action requires all vessels with a sea scallop dredge and that are required to have a Federal Atlantic sea scallop fishery permit, regardless of dredge size or vessel permit category, to modify their dredge(s) with a chain mat configuration when fishing south of 41° 9.0′ N. latitude (lat.) from the shoreline to the outer boundary of the EEZ. New Information On May 27, 2005, NMFS published a proposed rule to require the modification of sea scallop dredge gear for Federally-permitted vessels fishing in the mid-Atlantic. Comments on this proposed action were requested through June 27, 2005. Since the publication of the proposed rule, three new pieces of information have become available. First, the Northeast Fisheries Science Center (NEFSC) re-examined observer records to clarify the species identity of two individual sea turtle takes that were observed in the sea scallop dredge fishery in 1996 and 1997. With respect to interactions between sea scallop dredge gear and sea turtles, “observed take” and “observed” refer to interactions that were seen and documented by a NMFS approved observer while on-watch. The 1996 take was deemed to be a loggerhead sea turtle and the 1997 take a green sea turtle. Secondly, a sea turtle take occurred in August 2005 in the Georges Bank sea scallop dredge fishery. The observer was off-watch at the time the sea turtle was taken. It is important to note that when an observer is off-watch at the time of the take much of the information on the haul that would otherwise be recorded will not be included in the observer's report. This sea turtle was identified as a Kemp's ridley sea turtle and this identification was confirmed through photographs. Lastly, a bycatch estimate of loggerhead sea turtles captured in the 2004 mid-Atlantic sea scallop dredge fishery became available. This assessment estimated 180 loggerhead sea turtles (CV = 0.37) to have been captured in sea scallop dredge gear operating in the Mid-Atlantic from June 1 through November 30. Comments and Responses Nine comment letters from eight different individuals or organizations were received during the public comment period for the proposed rule. Five commenters were generally supportive of the action but provided comments on particular aspects of the proposed rule, and three commenters were opposed to the proposed action. Two public hearings were held during the comment period. One in Fairhaven, Massachusetts on June 16, 2005, and one in Cape May, New Jersey on June 22, 2005. Two individuals provided oral comments. Both of the oral comments were generally supportive of the proposed action. One of the individuals also provided written comments. A complete summary of the comments and NMFS' responses, grouped according to general subject matter in no particular order, is provided here. *Comment 1:* Four comments addressed the spatial extent of the proposed rule. One commenter supported using a longitudinal line at 70° 20′ W. longitude (long.) as the eastern boundary of the rule, one supported keeping the spatial extent as proposed as there is not evidence that sea turtles do not use the entire region, one stated that the spatial extent was too broad, and one urged caution when choosing a longitude closer to shore as sea turtles are found in warmer waters closer to the Gulf Stream. Additionally, this commenter felt that the northern boundary did not adequately assess the potential for interactions on Georges Bank and in the Gulf of Maine, that “near-shore” areas potentially prone to warmer waters should potentially be regulated more, and that special care should be taken for vessels to avoid waters close to known nesting beaches during sea turtle nesting and mating. *Response:* Sea turtle species that are found off the northeastern coast of the United States north of Cape Hatteras, North Carolina are, in order of frequency of occurrence, loggerhead, leatherback, Kemp's ridley, and green sea turtles (Shoop, 1980; Shoop and Kenney, 1992). This action will provide for the conservation of threatened loggerhead sea turtles and will have ancillary benefits for Kemp's ridley and green sea turtles. Loggerhead, Kemp's ridley, and green sea turtles undergo temperature dependent seasonal migrations along the mid-Atlantic coast (Morreale and Standora, 1998; Plotkin and Spotila, 2002). In general, these turtles occur in waters off North Carolina year round, in the inshore waters (i.e., bays, estuaries, and other coastal waters) of Virginia from May through November, and in New York's inshore waters from June through October (NMFS, 1994). All three are species are known to occur in Massachusetts waters as far north as Cape Cod, but with the exception of rare sightings and strandings are not known to occur in more northern New England waters (Shoop and Kenney, 1992; Mitchell *et al.* , 2003). Detailed information on the distribution of sea turtles can be found in the EA for this action. Off the northeastern U.S., loggerhead sea turtles are commonly sighted across the continental shelf from the shore to the shelf break as far north as Long Island (approximately 41° 9.0′ N. latitude), although further north and east sightings are sparse (CeTAP, 1982; Shoop and Kenney, 1992; Mitchell *et al.* , 2003). During CeTAP surveys, loggerhead sea turtles, the most common sea turtle observed taken in the sea scallop dredge fishery, were rarely documented north of 41° N lat (Shoop and Kenney, 1992). South of Cape Hatteras, loggerhead sea turtles are year-round residents (Mitchell *et al.* , 2003). In the western Atlantic, Kemp's ridley sea turtles are found year-round in the Gulf of Mexico and many juveniles migrate north along the east coast in the summer (Wynne and Schwartz, 1999). Off the northeastern U.S., inshore waters of southern New England, especially Cape Cod Bay and Long Island Sound, appear to be developmental habitat for juvenile Kemp's ridley and green sea turtles (Mitchell *et al.* , 2003; Morreale and Standora, 2005). During the summer and fall, Kemp's ridley and green sea turtles are expected to occur predominantly in inshore waters where the scallop fishery does not typically operate (Lutcavage and Musick, 1985; Keinath *et al.* , 1987; Morreale and Standora, 1993; Spotila *et al.* , 1998). In addition, although the broadest extent of the western Atlantic green sea turtle's range is from Massachusetts to Argentina, including the Gulf of Mexico and the Caribbean, they are considered rare north of Cape Hatteras (Wynne and Schwartz, 1999). In 1997, a green sea turtle was observed taken in the sea scallop dredge fishery operating off of New Jersey. Based on the identification of species taken in this fishery and the distribution of green and Kemp's ridley sea turtles, NMFS expects the take of these species in the sea scallop dredge fishery to be rare. The hawksbill sea turtle is uncommon in waters of the continental United States, preferring coral reefs. There are accounts of hawksbills in south Florida and a number are encountered in Texas. In the north Atlantic, small hawksbills have stranded as far north as Cape Cod, Massachusetts. However, many of these strandings were observed after hurricanes or offshore storms. No takes of hawksbill sea turtles have been recorded in the northeast or mid-Atlantic fisheries covered by the Northeast Fisheries Science Center observer program. Hawksbills are not expected to be present in the area impacted by this action. Interactions with sea turtles have been observed in the sea scallop dredge fishery south of 41° N. 9.0′ N lat. to the Virginia/North Carolina border. A total of 61 sea turtles have been observed taken in the Atlantic sea scallop dredge fishery during normal fishery operations from 1996 through October 31, 2005. Of these, 44 were identified as loggerhead sea turtles, 1 was identified as a green sea turtle, and 15 were hard-shelled sea turtles that could not be positively identified. An additional 13 sea turtles were reported captured while the observer was off-watch. These include a Kemp's ridley sea turtle in the sea scallop dredge fishery in August 2005. Prior to 2005, no sea turtle takes had been observed in the sea scallop dredge fishery outside the mid-Atlantic region. In the 1999 and 2000 scallop fishing years, relatively high levels of observer coverage (22 percent - 51 percent) occurred in portions of the Georges Bank Multispecies Closed Areas that were conditionally opened to scallop fishing. Despite this high level of observer coverage and operation of scallop dredge vessels in the area during June - October, which is generally when the water could be warm enough to support sea turtles, no sea turtles were observed captured in scallop dredge gear in these years. From 2001 through 2004, observer coverage was low in the Gulf of Maine (<1 percent in 2001, 2002, and 2004) and Georges Bank regions (<1 percent in 2001, 2002, and 2003; < 2 percent from September through November 2004 with most of the coverage occurring in November) (Murray 2004, 2005). In August 2005, a Kemp's ridley sea turtle was taken at approximately 40° 58′ N. lat./67° 16′ W. long. by a dredge vessel operating on southern Georges Bank indicating that takes in this area are possible. Based on:
(1)the known distribution of sea turtles,
(2)sea scallop dredge fishing effort, and
(3)the observed take of sea turtles in this fishery, NMFS expects the take of sea turtles by dredge vessels operating in the New England sea scallop dredge fishery on Georges Bank to be rare. However, the take of the Kemp's ridley sea turtle on southern Georges Bank is evidence that takes in this area are possible. It should be noted that this take occurred on southern Georges Bank, south of the 41° 9.0′ N. lat. boundary. Although takes of sea turtles north of this boundary are possible, NMFS expects interactions between sea turtles and sea scallop dredge gear in this area to be rare. This final rule requires vessels fishing south of 41° 9.0' N. lat. from the shoreline to the outer boundary of the EEZ to use the chain mat configuration from May 1 through November 30 each year. Mating for loggerhead sea turtles takes place in late March to early June in the general vicinity of the nesting area, and eggs are laid throughout the summer. In the western Atlantic, most loggerhead sea turtles nest from North Carolina to Florida and along the Gulf Coast of Florida, although Virginia is the northernmost extent of loggerhead nesting on the eastern coast of the United States (DeGroot and Shaw, 1993; USFWS 2004). Sea scallops only occur in inshore waters in the Gulf of Maine and Canada. Therefore, NMFS does not anticipate the overlap of sea turtles and sea scallop dredging in inshore areas during nesting and mating season. *Comment 2:* Two comments addressed the temporal extent of the proposed rule. One commenter supported the use of November 30, the preferred alternative, rather than October 15, as described in non-preferred alternative 1, to better account for variability in sea turtle migration and fishing activities. The other commenter stated that the proposed rule is for too long a time and the modification should be required when sea turtles are in the area (a dynamic area management
(DAM)program). The commenter explained that the DAM program could be implemented similarly to the program currently used for right whales and could use the observer program to report the presence of sea turtles in the area. The commenter also stated that the use of the turtle chains will consume more fuel, catch less scallops, and be less efficient. The commenter believes that a DAM program would minimize this loss of efficiency and the use of a non-renewable resource, fuel. *Response:* The temporal extent of these proposed measures are based on the time period associated with the overlap of sea turtles and the sea scallop dredge fishery using Cape Hatteras, North Carolina as the lower boundary. Cape Hatteras was chosen as the lower boundary as NMFS does not anticipate any fishing south of Cape Hatteras due to a lack of scallop resources. In general, hard-shelled sea turtles move from offshore to inshore and/or from south to north in the spring and in the opposite direction in the fall. These turtles occur year round in waters off North Carolina; however, they are considered rare North of Cape Hatteras in the winter (Mitchell *et al.* , 2003). Hard-shelled sea turtles occur in the inshore waters (i.e., bays, estuaries, and other coastal waters) of Virginia from May through November, and in New York's inshore waters from June until October (NMFS, 1994). Interactions between the sea scallop dredge fishery and hard-shelled sea turtles have been documented from late June to late October, and the potential for interactions exists during May and November due to the overlap of sea turtles and fishing distribution. Interactions with sea turtles have been observed in the sea scallop dredge fishery south of 41° 9.0' N. lat. to the Virginia/North Carolina border. Based on the known distribution of sea turtles, as described in the response to Comments 1 and 2, the observed take of sea turtles in the sea scallop dredge fishery from June through October, and to account for variability in both sea turtle migration and fishing activity, the final rule requires vessels to use the modified sea scallop from May 1 through November 30 each year. At this time, it would not be feasible to implement a DAM program for sea turtles. The DAM program for right whales is based on scientific aerial survey effort. These aerial surveys for right whales are not designed to assess sea turtle distribution and, currently, there is no aerial survey program for sea turtles. The observer program is not the appropriate platform for looking for sea turtle aggregations as sea turtles are often difficult to see from a vessel, the program is not a scientific survey to assess distribution of protected species, and observer locations are determined by many criteria and may not be appropriate for evaluating aggregations of turtles in the mid-Atlantic. *Comment 3:* One commenter stated that the proposed rule should identify areas more prone to sea scallop dredge - sea turtle interactions based on water temperature and known sea turtle biology. The commenter also stated that although it is not reasonable to ask that all scallop dredging cease during warmer months, dredging should be restricted in shallow embayments and deeper offshore waters during these months. *Response:* During 2001-2003, sea surface temperature
(SST)was found to be significant factor influencing sea turtle bycatch rates in the mid-Atlantic sea scallop dredge fishery. In 2001 and 2002, a higher probability of turtle bycatch occurred after waters had warmed to 19 °C and in 2003, higher probabilities occurred after waters warmed to 22 °C. These differences may reflect inter-annual variations in SST or turtle distributions, shifting patterns in the fishery, or interactions between random samples and statistical models (Murray, 2004). Murray
(2004)found that there may be a minimal threshold above which sea turtle bycatch is likely to occur, although this minimal temperature threshold is likely to fluctuate from year to year. SST was not found to be a significant predictor of sea turtle bycatch rates in the mid-Atlantic during the 2004 fishing year (Murray, 2005). Interactions in 2004 may have been influenced by a combination of depth zone and SST, and the small number of takes in 2004 relative to the number of dredge hours examined (approximately 1 take:1,000 observed dredge hours) may have precluded the detection of a significant effect. The rare nature of turtle interactions in 2004 made it difficult to identify variables significantly affecting bycatch rates, and even area and depth, selected for a best fit, were not strong predictors (Murray, 2005). Due to the influence of temperature in 2001, 2002, and 2003 affecting sea turtle bycatch rates, NMFS considered an alternative which would provide protection to sea turtles when sea surface temperatures reached a level at which elevated sea turtle bycatch was expected. Under the alternative, vessels would be prohibited from fishing south of 41° 9.0′ N. lat. and north of 38° 0.0′ N. lat. from May 1 through October 31 and south of 38° 0.0′ N. from May through November 30. NMFS rejected this alternative from further analysis as it would result in essentially the same impacts to sea turtles and the fishing industry as a closure from May 1 through November 30 each year (see Comment 4 for a more detailed response regarding seasonal closures) and, given the recent bycatch analysis, the relationship between elevated levels of bycatch and SST is unclear. Requiring the chain mat modification when sea surface temperatures reached a level at which elevated sea turtle bycatch was expected would likely result in the same impacts as this action. The sea scallop dredge fishery is not expected to overlap with sea turtle distribution in shallow embayments of the mid-Atlantic as sea scallops do not occur in shallow embayments there. Sea scallops only occur in inshore waters in the Gulf of Maine and Canada. *Comment 4:* One comment was received that supported non-preferred alternative 3 (seasonal closure of the mid-Atlantic) to effectively protect sea turtles from scallop dredging during the summer by removing sea scallop dredge vessels from the times and places where sea turtles occur. The commenter stated that this is the only alternative that can be shown to effectively reduce loggerhead sea turtle takes and subsequent injury and mortality, that concern about displacement of effort adversely affecting habitat should not block protection of sea turtles, and that economic considerations in no way argue against alternative 3, in part because the economic analysis of alternative 3 is grossly irrational (see Comment 17). *Response:* A seasonal closure of all waters south of 41° 9.0′ N. lat. was considered and analyzed in the EA. This alternative would provide the most protection to sea turtles as scallop dredge vessels would not be in the area when sea turtles are present. Sea scallop fishing is not distributed evenly throughout this area. In a review of Vessel Trip Reports for 2003 and 2004, reported trips for the mid-Atlantic (defined in Murray as approximately 41°15′N/70°00'W to 36°06′N/70°00′W) during the period June through November occurred from approximately 75° 30.0′ W. long. to approximately 71° W long. (Murray 2004, 2005). The commercial sea scallop fishery in the mid-Atlantic generally operates at depths between 35 - 75 m (memo from John Boreman to Patricia A. Kurkul, 6 December 2004). At this time, it is not known whether sea turtles interact with sea scallop dredge gear throughout the area in which the fleet operates in the mid-Atlantic or if interactions are limited to certain areas and certain times. Observer coverage has documented several trips on which more than one sea turtle was observed taken. In 2002, out of 62 observed trips, one of the observed trips took three sea turtles and four of the observed trips took two sea turtles. In 2003, out of 71 observed trips, one of the observed trips took four sea turtles, two of the observed trips took three sea turtles, and three of the observed trips took two sea turtles (Murray, 2004), and in 2004, out of 172 observed trips, one observed trip took two sea turtles (Murray, 2005). At this time, NMFS does not know why some trips have multiple takes and does not have sufficient evidence to refine a potential closure area further. A closure of the mid-Atlantic would likely result in a shift of effort further north. A behavioral model, which does not exist at this time, would be necessary to assess shifts in effort. In the absence of this model, NMFS assumed the worse case scenario that vessels would choose not to fish an alternative area. According to the 2003 VTR data, of the 314 scallop dredge vessels that fished in the mid-Atlantic during May through November, 208 vessels fished exclusively in the mid-Atlantic region and 106 vessels fished in the mid-Atlantic and further north. If, under a closure, vessels choose to relocate to fishing grounds not affected by the closure, gear conflicts may result. As the number of scallop vessels fishing on these grounds increases, the vessels would be competing with other scallop vessels that have historically fished these grounds as well as with each other. Other gear conflicts might include the lobster fishery and, to a lesser extent, the groundfish fishery. It is difficult to determine how much effort would increase on Georges Bank based on a closure in the mid-Atlantic, but if effort were to increase on Georges Bank, there could be an increase in the bycatch of groundfish in this area. The extent of this shift and its impacts on physical, habitat, and biological resources in these areas cannot be quantified at this time. In general, a shift in effort would increase impacts to habitat in the areas outside of the mid-Atlantic and perhaps in the mid-Atlantic during the periods it would be open to sea scallop dredge fishing. During the closure (May through November), it is expected that there would be beneficial impacts to the mid-Atlantic habitat. The net impacts, and the magnitude of these impacts, to habitat are not clear. The economic analysis for a seasonal closure in the mid-Atlantic assumed the economically worst case scenario, that the alternative would not result in a displacement of effort. Instead, the analysis assumed that the vessels would not fish during the closure period (see Comment 17 for a more detailed response regarding the economic analysis). It is likely that some vessels will shift their fishing effort to other areas; therefore, the economic impact will be less than that assumed for the final EA. Due to these factors - the broad extent of the closure area, displacement of effort, and uncertainty of the extent of the area in which interactions are occurring - non-preferred alternative 3 was rejected. *Comment 5:* One commenter stated that all dredging should be banned year round in the area proposed. This commenter also stated that all longlines and purse seine fishing should be banned. *Response:* As described in the response to Comment 2, sea turtle presence varies with season. The capture of sea turtles in sea scallop dredge gear has been documented in the mid-Atlantic from June through October and the potential for takes exists in May and November due to the overlap of the sea scallop dredge fishery with sea turtle distribution. As described above, a single sea turtle take has been documented in the sea scallop dredge fishery on southern Georges Bank in August. As sea turtle distribution and sea scallop dredge effort are not expected to overlap from December 1 through April 30, extending the effective period of the rule through these months is not expected to provide additional benefit to sea turtles. A seasonal closure of the mid-Atlantic to sea scallop dredging is addressed in the response to Comment 4. The comments regarding longline and purse seine fisheries are not relevant to the proposed rule. *Comment 6:* Two comments were received relating to scallop dredge gear and operational modifications in the fishery. One commenter stated that the rule should require modifications to the dredge frame and cutting bar to reduce injury to sea turtles as well as modifications in the operation of the fishery, including not setting gear if a sea turtle is seen in wake, stopping gear at the 10-fathom mark for 30 seconds during haul back, and restricting tow times to reduce drowning of sea turtles. Another commenter stated that NMFS should consider additional ways to reduce interactions of dredges with turtles, such as keeping discards on board during fishing operations. *Response:* NMFS is working with industry to evaluate the effectiveness of a dredge with a modified cutting bar and bail. This dredge was designed to reduce serious injury to sea turtles that may be encountered on the bottom. Initial testing of the gear in Panama City, FL showed that the gear was capable of deflecting a model turtle over the bail. However, additional studies are necessary to assess the effectiveness of this modification at reducing the severity of interactions on the ocean floor and at maintaining the scallop catch. This gear research is on-going. It has been suggested that the discard of scallop viscera during fishing operations may be attracting sea scallop dredge vessels to the fishing area. White
(2004)reported loggerhead sea turtles opportunistically feeding on discards from gillnet vessels docked at a quay in Greece and there are anecdotal reports of sea turtles opportunistically feeding on discards in the shrimp trawl fishery. It is unclear whether the turtles were drawn to the vessel because of the discards or just happened to be in the same place as the vessels at the same time. At this time, NMFS has no evidence to refute or support the possibility that discards may be attracting sea turtles to the scallop vessel. In addition, it is not clear what the effect would be from a prohibition of dumping viscera. Sea turtles that may be attracted to discarded viscera might disperse away from fishing vessels if the practice is prohibited. Alternatively, these turtles may remain in the fishing area and feed on natural prey in the benthos. It is not clear that a prohibition on the discard of sea scallop viscera would reduce the risk of interaction. NMFS does encourage observers to collect all sea turtle carcasses brought on board for necropsy, including an analysis of stomach/GI samples for prey items. However, this is logistically difficult and, to date, only one sea turtle carcass has been returned and necropsied. Stomach and intestinal samples could not be obtained from this turtle due to its condition. In the draft EA for the proposed rule and the final EA, NMFS considered an alternative that would require operational modifications in the sea scallop dredge fishery. Although operational modifications could provide some benefit to sea turtles, the extent of these benefits is unclear. It would be difficult to ensure compliance and to assess the impact of these modifications on sea turtles. Due to this uncertainty, this alternative was rejected and not further analyzed. *Comment 7:* One commenter stated that the decrease in scallop catch would be greater than the 6.71 percent observed in the experimental fishery. Another commenter stated that the proposed rule affords a practical solution, that the modification could be retrofitted onto existing scallop dredges, and that the costs of the chains and losses of scallops are a reasonable measure for insuring the conservation of sea turtles stocks as well as the viability of the industry. *Response:* During the experimental fishery to test the chain mat configuration, scallop catches were variable from vessel to vessel and trip to trip, with differences ranging from -30.88 percent to 7.28 percent (average -6.71 percent). The study authors and NMFS gear technologists anticipate that the difference in catch will decrease as industry becomes more familiar with the chain configuration. However, if vessels with a loss of catch do not choose not to offset this loss with an increase in effort, there is the potential for loss of revenue. *Comment 8:* Two comments were received on the species considered in the proposed rule. One commenter stated that the proposed rule should consider other species of sea turtles found in the geographic area of the proposed measures. One commenter stated that Kemp's ridley, green, and leatherback sea turtle may be captured by scallop dredges and trawls as a number of individuals captured in the fishery are not identified to species. In addition, the commenter stated that the unobserved take reported as a leatherback in the experimental fishery should be considered valid. The commenter believes that all four species are likely to be taken in the fishery; therefore, consultation should be reinitiated and take of all four species considered. *Response:* Since the publication of the proposed rule, two new pieces of information have become available indicating that Kemp's ridley and green sea turtles are vulnerable to capture in sea scallop dredge gear. Two sea turtles were observed taken in the sea scallop dredge fishery from 1996 through 1997. For the initial and subsequent Biological Opinions on the Atlantic Sea Scallop Fishery Management Plan, these sea turtles were considered unidentified hard shelled species based on discussions with some of the staff of the NEFSC. Subsequent to the publication of the proposed rule, the records maintained by the Fisheries Sampling Branch, NEFSC were re-examined and, on August 23, 2005, the NEFSC indicated that the 1996 sea turtle should be considered a loggerhead and the 1997 sea turtle should be considered a green based on written documentation provided by the observer and the observer's experience. Both of these observed takes occurred in the mid-Atlantic sea scallop dredge fishery. Sea turtle species that are found off the northeastern coast of the United States north of Cape Hatteras, North Carolina are, in order of frequency of occurrence, loggerhead, leatherback, Kemp's ridley, and green sea turtles (Shoop and Kenney, 1992). Additional information on the distribution of loggerhead, Kemp's ridley, hawksbill and green sea turtles is found in comment 1 and the EA for this action. This action will provide for the conservation of threatened loggerhead sea turtles. Based on information received subsequent to the publication to the proposed rule, it is also expected to have ancillary benefits for Kemp's ridley and green sea turtles, which have been observed taken in the sea scallop dredge fishery, albeit to a lesser extent than loggerheads. While the sea scallop dredge fishery does overlap with leatherback sea turtle distribution, NMFS has no confirmed report that this gear interacts with leatherback sea turtles, either in the water column or on the bottom. During the experimental testing of the modified sea scallop dredge gear, two unobserved interactions were reported. One of the unobserved interactions was reported by the fisherman as a loggerhead sea turtle. The second unobserved interaction was reported by the fisherman as a leatherback. NEFSC's general protocol for confirmation of at-sea species identification requires that the species be considered as unknown unless either the observer is experienced in sea turtle identification and has confidence in the identification, or the observer is inexperienced and has provided supporting information (i.e., photos, tissue samples). As far as the NEFSC is aware, the fishermen reporting the take of the leatherback and the take of the loggerhead have not been trained nor are they experienced in identifying sea turtle species. No supporting materials, such as photos or tissue samples, have been provided. Therefore, based on the confirmation protocol for at-sea species identification, the NEFSC considers the species identification of these takes to be “unknown turtle species”. Leatherback sea turtles are predominantly a pelagic species and feed on jellyfish. Since scallop dredge gear operates on the bottom, leatherback sea turtles are less likely to encounter this gear compared with loggerhead sea turtles. Given their large size, prey and habitat preferences, leatherback sea turtles are not expected to be struck by the gear operating on the bottom or caught in sea scallop dredge gear. In the unlikely event that a leatherback sea turtle were to interact with sea scallop dredge gear, the chain mat configuration would prevent it from entering the dredge bag, and would prevent subsequent injuries that might ensue from such capture. As provided in 50 CFR 402.16, reinitiation of formal consultation is required where discretionary Federal agency involvement or control over the action has been retained and if:
(1)the amount or extent of incidental take is exceeded;
(2)new information reveals effects of the agency action that affect listed species or critical habitat in a manner or to an extent not considered in the previous opinion;
(3)the agency action is subsequently modified in a manner that causes an effect to listed species or critical habitat not considered in the previous opinion; or
(4)a new species is listed or critical habitat designated that may be affected by the action. This action does not trigger reinitiation. Although this action does not trigger reinitiation of consultation, NMFS reinitiated ESA section 7 consultation on the Scallop FMP on November 1, 2005. Observer coverage of the Atlantic sea scallop fishery in the 2005 fishing year and a review of past observer records has revealed new information on the fishery in relation to its effects on ESA-listed sea turtles. This information includes the take of five loggerhead sea turtles in the sea scallop trawl fishery, the take of a Kemp's ridley on southern Georges Bank, and confirmation from the NEFSC that a turtle observed taken in scallop dredge gear in 1997 should be considered a green sea turtle. *Comment 9:* Several comments were received on the nature of the interaction. One commenter expressed concerns that the tests on the chain mats have been limited and that additional research is needed to determine how “dredge bars” injure and kill sea turtles. A second commenter stated that it is unknown what happens when turtles interact with the chain mat modified dredge and that there is a significant risk that the chains do not reduce take, but simply change the nature of the interaction. This commenter also stated that, without video monitoring, it is possible that the rule may prevent real attempts to address the problem by hiding what is happening from view and that, to be effective, video work must be done in a systematic manner prior to proposing the modifications as a regulation. The commenter stated that the proposed action may do very little to reduce mortality and injury to sea turtles and that NMFS admits that the chain mat configuration would not lessen the number of sea turtles taken, injured, or killed by the dredge on the sea floor. The commenter stated that it stands to reason that a significant number of the sea turtles that are seriously injured and end up dying are caught on the sea floor as the dredge is towed on the sea floor for far more time than it is hauled up to the boat through the water column. Lastly, the commenter states that the EA does not appear to analyze how often injuries occur from interactions with the dredge in the water column, but the implication is that even without the turtle chains, such interactions are unlikely. Another commenter stated that it is unlikely that strikes by scallop dredges with turtle excluder devices represent a significant source of mortality or injury while fishing on bottom. The commenter stated that while fishing, dredges are towed at a relatively slow speed and that it appears that most injuries result from negative interactions caused when turtles enter the dredge, remain submerged, or are brought on deck. *Response:* NMFS recognizes the uncertainty regarding whether sea turtles interact with sea scallop dredges as the dredge is dragged along the bottom, as the dredge is hauled back, or both. It takes approximately 1 minute to set a dredge and approximately 10 minutes to haul back, dump the catch, and reset the gear. For the remainder of the haul, the gear is on the bottom. However, it is not known where sea turtles are encountering the gear. It is likely that sea turtles are interacting with the gear both in the water column and on the bottom. Sea turtles have been observed in the area in which sea scallop gear operates and they have been seen near scallop vessels when they are fishing or hauling gear. In addition, sea turtles are known to forage and rest on the sea floor as part of their normal behavior. The condition of sea turtles observed taken in the sea scallop dredge fishery ranges from alive with no apparent injuries to alive and injured to fresh dead. As described below, NMFS believes that interactions between sea turtles and sea scallop dredge gear that occur on the bottom are likely to result in serious injury to the sea turtle. Based on this assumption, NMFS believes that the unharmed/slightly injured turtles observed captured in the sea scallop dredge bag follow an interaction with sea scallop dredge gear in the water column. Data do not exist on the percentage of sea turtles interacting with the chain mat-modified gear that will be unharmed, sustain minor injuries, or sustain serious injuries that will result in death or failure to reproduce. However, there are several assumptions that can be made to assess the degree of interaction. With the chain mat installed over the opening to the dredge bag, it is reasonable to assume that sea turtles, which would otherwise enter the dredge bag, will instead come into contact with the chain mat at least. NMFS recognizes that this modification may not reduce the number of sea turtles interacting with sea scallop dredge gear, but it is reasonable to assume that the modification will reduce mortality and the severity of injury following interactions that occur in the water column. After an interaction in the water column, severe injuries to sea turtles following capture in a dredge bag without the chain mat configuration likely result from crushing by debris in the dredge bag, dumping of the turtle on the vessel's deck, or crushing them with falling gear. NMFS does not have information on the proportion of takes occurring in the water column. However, preventing the turtles from entering the dredge bag will prevent injuries resulting from such capture and likely result in a non-serious interaction following an encounter in the water column. With the chain mat in place, it is reasonable to assume that the sea turtles on the sea floor would still interact with the gear, but that the nature of the interaction would be different. With the modified gear, the sea turtles may still be hit by the leading edge of the frame and cutting bar and would likely be forced down to the sea floor rather then swept into the dredge bag. Since the turtles are not being swept into the bag, they could be run over by the dredge bag and club stick. At this point, the turtle will have likely already been hit and run over by the cutting bar and the leading edge of the dredge frame, which constitutes a substantial weight. In 2005, NMFS worked with industry to test a dredge with a modified cutting bar and bail designed to minimize the severity of impacts to turtles that may be encountered on the bottom. A standard New Bedford style dredge was used as a control, and both dredges were equipped with the chain mat configuration, although the purpose of the project was not to study the chain mats. The project used turtle carcasses and model turtles to simulate a worse case scenario of a dredge overtaking a sea turtle lying on the bottom. During the study, the turtle carcasses were observed lodged in front of the cutting bar and pushed along, eventually going under the cutting bar and getting caught on the chain mat. The model turtle was deployed on one tow with the modified dredge. During this tow, the model turtle was deflected over the bail of the modified dredge, indicating that this type of modification might be effective at reducing the severity of encounters on the bottom. It is important to note that the project was limited in that behavioral responses of a live turtle encountering a dredge could not be assessed. The video from the study did show that it is possible that sea turtles encountering the dredge on the bottom may become caught on the chains after being hit by the leading bar of the dredge. However, this follows the turtle being struck by the leading edge of the dredge during which it is likely to have sustained serious injuries. NMFS has made the conservative assumption that a turtle in a bottom interaction sustains serious injuries on the bottom regardless of whether the chain mat is used. Under this conservative assumption, there would not be a benefit from the chain mat for bottom interactions. This assumption, however, may be too conservative in that it is possible that turtles in a bottom interaction may only receive minor injuries. In the unlikely scenario of a turtle receiving only minor injuries following a bottom interaction, the chain mat modification would prevent serious injuries that result from capture in the dredge bag (i.e., injuries from debris in the bag, forced submergence, dropping on deck, or crushing by the dredge). A detailed description the assumptions made and the assessment of the interactions can be found in the EA on this action. NMFS recognizes that the interactions between sea turtles and sea scallop dredges are likely to continue and may not be observed from on deck. In 2004 and 2005, NMFS conducted video research to document the nature of the interaction between sea turtles and sea scallop dredge gear. Approximately 80 hours of video were collected and reviewed. No sea turtles were documented. Further video work may be conducted under the Sea Scallop Research Set Aside Program. It is evident from these studies that using video to document the specific nature of sea turtle-sea scallop dredge interactions, in general, and sea turtle-chain mat interactions specifically, is logistically difficult. Due to the low number of interactions between sea turtles and sea scallop dredge gear (approximately 1 take per 1,000 observed dredge hours in 2004), it will be difficult to obtain sufficient video documentation of sea turtle behavior to allow a thorough analysis of the types of interactions that may occur. Waiting for such video documentation would result in an extended delay in the use of a chain-mat modified dredge. As this modification is expected to provide a net benefit to sea turtles, NMFS believes it is important to move forward without delay. In addition, NMFS will monitor scallop fishing effort for significant increases or decreases in effort in the mid-Atlantic and the possible effects that changes in effort may have on sea turtles. NMFS is continuing to investigate modifications of the gear that may reduce the effects of interactions which occur on the ocean bottom. *Comment 10:* Two comments were received on the level of take in the sea scallop fishery. One commenter stated that NMFS has repeatedly failed to recognize the extent and impact of the scallop fishery's impact on threatened and endangered species, that the anticipated take level in the proposed rule does not incorporate the supposed benefits of the chain mat requirement, and that these benefits should be reflected in a reduction of allowed take. If the action is not expected to reduce take and injury, then further efforts are needed. In addition, the commenter urged NMFS to expeditiously provide information on genetic samples taken in this fishery. The second commenter stated that the proposed rule's estimated take was too low because the 2004 Biological Opinion did not include a number of ways that dredges can take sea turtles (i.e., being hauled up on top of the gear, being wedged in the forward parts of the dredge frame, being held against the dredge by the pressure of the flow of water, or by being run over by the dredge and chain bag). *Response:* According to the December 2004 Biological Opinion, the agency anticipates that up to 749 sea turtles will be taken each year without the chain mat configuration in place, and that up to 479 of these are expected to sustain injuries leading to death or failure to reproduce. As described in the proposed rule (70 FR 30660) and in the response to Comment 9, up to 749 turtles may still interact with the gear. However, the chain mat configuration is expected to prevent serious injury leading to death or failure to reproduce caused by dumping of the turtles on the vessel's deck and crushing them by falling gear or debris in the bag following an interaction in the water column. At this time, the proportion of sea turtles interacting with the dredge gear in the water column cannot be quantified. In 2004 and 2005, NMFS worked with industry to conduct approximately 80 hours of video research to document the nature of the interaction between sea turtles and sea scallop dredge gear and to investigate the behavior of sea turtles around sea scallop dredges, but no sea turtles were documented. Tissue samples for genetics samples have been collected from loggerhead sea turtles captured in the sea scallop dredge fishery, and the results are still pending. NMFS is working to obtain these results as soon as is reasonably possible. The bycatch estimate completed by the NEFSC, and the anticipated take level in the 2004 Biological Opinion, included any interaction occurring during an on-watch haul, that was not moderately or severely decomposed upon capture. This includes sea turtles hauled up on top of the gear, wedged in the forward parts of the dredge frame, or held against the dredge by the pressure of the flow of water as observed from on deck. Sea turtles may interact with sea turtle dredge gear in the water column or on the sea bottom and not be brought to the surface. These interactions cannot be quantified at this time. *Comment 11:* A number of comments were received on the need for additional research including monitoring the degree of progress made in reducing sea turtle bycatch, modifications to the dredge frame and cutting bar, video footage to document the interactions, and observer coverage on scallop dredge vessels and underwater video cameras on the dredge to evaluate the effectiveness of the chain mats. One commenter also expressed concern that the tests on the chain mats have been very limited, and urged NMFS to provide extensive observer coverage to determine the effectiveness of the chain mats. *Response:* As described above, NMFS will continue to monitor the take of sea turtles and the effectiveness of this regulation in the sea scallop dredge fishery through observer coverage, fishing effort data, and other data, as available. NMFS is currently working with industry to research the effectiveness of a dredge with a modified bail and cutting bar at reducing the severity of sea turtle interactions that are occurring on the sea floor bottom and retaining sea scallop catch. This research is described above. Video work conducted in 2004 by the NEFSC and industry did not document any interactions between sea turtles and sea scallop dredge gear, but was successful in devising a methodology to video in front of sea scallop dredges. In 2005, approximately 73 hours of video work was conducted to document the nature of the interaction between sea turtles and sea scallop dredges and to investigate the behavior of sea turtles around sea scallop dredges. No sea turtles were documented. *Comment 12:* One commenter stated that the proposed action could have profound adverse effects on efforts to protect loggerhead sea turtles and thus on loggerhead turtle populations. The commenter claimed that without video monitoring, no one will know how many loggerhead turtles were taken, injured, and killed underwater, an accurate estimate of sea turtle takes would be impossible, and neither individuals nor the agency would be able to assess whether these takes may exceed the December 2004 incidental take statement. Another commenter expressed concerns that the chain mat modified dredge may contribute to underestimates of sea turtle capture by preventing injured and dead turtles from being brought on deck. *Response:* NMFS recognizes that interactions between sea scallop dredge gear and sea turtles are likely to occur and that these interactions may not be observed from on deck. As described above, NMFS will continue to use observer information, fishing effort data, and other data, as available, to monitor the fishery and its possible effects on sea turtles. NMFS will use observer data to continue to evaluate the take of sea turtles in other parts of the dredge (i.e., the forward parts of the frame and on top of the gear). In addition, observer coverage may provide information on the effectiveness of the chain mat modification. NMFS will monitor scallop fishing effort for significant increases or decreases in effort in the mid-Atlantic and the possible effects that changes in effort may have on sea turtles. This will be of particular importance for monitoring the level of take exempted in the Incidental Take Statement
(ITS)for the fishery. NMFS will develop a methodology, using observer and fisheries data, and other information as available, to assess compliance with the ITS. In addition, further video research may be conducted under the Sea Scallop Research Set Aside Program to evaluate the behavior of sea turtles around sea scallop dredge gear and to document the specific nature of the interaction. *Comment 13:* One comment was received regarding enforcement and monitoring of regulations to ensure vessel compliance. The commenter stated that a modification deadline should be implemented, that the proposed rule should mention self-reporting programs and observer programs because reporting and record-keeping measurements are necessary to assess if the modification is an effective means of reducing bycatch, and that NMFS should ensure that vessels have complied with the modification. *Response:* The effective date for the regulations is 30 days after publication of the final rule in the **Federal Register** . NMFS will continue to use observer information, fishing effort data, enforcement, and other data, as available, to monitor the fishery and its possible effects on sea turtles. This includes self-reporting programs, such as the Vessel Trip Report program that is already in place in the fishery. *Comment 14:* One commenter stated that the rule is more appropriately enacted under the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act), rather than the ESA. The Atlantic sea scallop fishery is managed by the New England Fishery Management Council, which has expertise in the management of the scallop fishery and would be able to more quickly and efficiently adjust the rules as new information becomes available. *Response:* Implementing the proposed regulation under the ESA rather than the Magnuson-Stevens Act does not prevent NMFS from responding quickly and efficiently as new information becomes available. In addition, implementing this action under the ESA does not preclude future actions from being implemented under either the ESA or the Magnuson-Stevens Act, as appropriate. *Comment 15:* One commenter stated that NMFS should consider ways for fishermen, working in conjunction with appropriate veterinary or rescue facilities, to bring turtles with cracked shells to these facilities. In addition, developing good techniques to repair turtle shells damaged by boats and fishing gear is a growing need to be addressed. *Response:* Currently, information regarding the transfer of injured turtles to appropriate rehabilitation facilities is included in the fishery observer training packets, including contacts for appropriate/authorized facilities from Maine to North Carolina. Observers are encouraged to make these arrangements for injured sea turtles as logistics and practicality allow, taking into account trip length and ability to transfer turtles quickly and safely. It is generally considered prohibitive if a turtle is taken during a multi-day trip, as a seriously injured turtle would need to be transferred immediately, all resources to enable the transfer would be voluntary/donated, the receiving facility must be able to accept the case, and must agree to the transfer before a turtle is brought in. Vessels in the limited access fleet generally take extended trips of up to 12-20 days. Often, based on NMFS' experience with trained observers, the transportation of sea turtles to rehabilitation facilities is logistically challenging. Currently, an agent or employee of NMFS while acting in the course of his/her official duties is exempt from the take prohibitions on endangered and threatened sea turtles while aiding an injured sea turtle in the marine environment. Regulations under 50 CFR 223.206(d) require fishermen who incidentally take turtles to return them to the water immediately (or after resuscitation), prohibit the landing, offloading, or transhipping of incidentally caught sea turtles. NMFS will consider whether and how it is possible under these provisions for a fishermen to work with rehabilitation facilities to bring sea turtles to these facilities. Currently, fishermen should contact the Sea Turtle Stranding and Salvage Network to see if a network member would meet the vessel and retrieve the turtle at sea. *Comment 16:* One commenter stated that the draft EA strongly supports a finding of significant impact. They state that the EA contends that the chain mat modification would significantly benefit sea turtles and that the characteristics of the geographic area, the presence of loggerhead sea turtles, indicate the need for an Environmental Impact Statement. They also state that the action is highly controversial, highly uncertain, and creates a significant precedent. *Response:* The draft EA supports a finding of no significant impact. There is expected to be a benefit to sea turtles by reducing serious injury and mortality following a take in the water column; however, the degree of benefit is limited given that the installation of a chain mat would only reduce the severity of injuries resulting from a portion of possible takes. No unique characteristics of the geographic area were identified. The presence of loggerhead sea turtles in the mid-Atlantic is not a unique characteristic of the area. The gear modifications are limited in geographic area and time and are implemented in an effort to facilitate the coexistence of fishing activity and sea turtles. These factors restrict the scope of the effects. This action is not highly controversial given that the action is designed to benefit sea turtles, it would have a relatively small impact on the fishing industry, and the industry has petitioned NMFS for a similar action. While there is not perfect information available on the nature of the interaction between sea scallop dredge gear and sea turtles, NMFS has made reasonable assumptions in evaluating the risks and benefits of the proposed action. The best available scientific information shows that the use of the chain mat will prevent sea turtles from entering the dredge bag and prevent injuries ensuing from their capture. The action also does not set a significant precedent as gear modifications are a commonly used tool to reduce the severity of interactions between fishing gear and sea turtles. *Comment 17:* One comment was received on the economic analysis of alterative 3. The commenter stated that the economic analysis is grossly irrational as it does not take into account a shift of effort in the fishery, but rather assumes that during the closure season fishing activity that would ordinarily take place in the mid-Atlantic would simply disappear. According to the comment, the economic analysis must take shifting effort into account and properly analyze and quantify the economic impact caused by the limited seasonal displacement. *Response:* To properly estimate potential shifts in scallop dredge fishing effort, an economic behavioral model, which does not exist at this time, would be needed. In the absence of this model, NMFS assumed the worst case scenario in assessing the economic impacts of a seasonal closure. The conservative approach is to overestimate, rather than to underestimate, the total industry loss due to a regulation. According to the 2003 VTR data, 208 of the 314 vessels that were included in the analysis fished exclusively in the mid-Atlantic and 106 vessels fished both in the mid-Atlantic and the New England fishing areas. NMFS recognizes that some of these vessels would likely shift their effort to other areas if the mid-Atlantic were closed to sea scallop dredge fishing from May 1 through November 30. *Comment 18:* One comment was received on the failure to provide data on skate bycatch at the species level in the experimental fishery. The barndoor and thorny skates are included on NMFS national “Species of Concern” list and the American Fisheries Society of “Marine Species at Risk”. The commenter stated NMFS should lead the way in fulfilling the Skate Fishery Management Plan's goals to improve the data-poor situation with skates by ensuring all approved experimental fisheries in the region record and report skate catches by species. *Response:* The sea scallop dredge research on the chain mat modification was conducted under a grant through the NMFS Sea Scallop Research TAC Set-Aside program. As such, the experimental fishery was operating under the Atlantic Sea Scallop Fishery Management Plan, which requires that vessels submit Vessel Trip Reports
(VTR)on which all bycatch species are reported to species level whenever possible. In addition, bycatch information for experimental fisheries is requested to the highest level possible. VTR codes for skates at the species level have existed since 2003 and NMFS has revised the printed VTR instructions to include species level codes for skates although they have yet to go to print. However, it is permissible for fishermen to report skates as unspecified and not at the species level. Thus, data collected at the species level may be incomplete. *Comment 19:* One commenter stated that the information used to support the preferred alternative is based on assumptions and guesswork, not scientific research and that this information is inadequate. The commenter stated that it is crucial to assess the effects of turtle chains through underwater video monitoring prior to proposing the non-experimental use of the chain mat. Furthermore, the commenter states that the studies on which the preferred alternative is based are fatally flawed as they rely only on on-deck observations and so only addressed whether the chain mat could reduce the number of sea turtles caught in the dredge and did not address whether the chains reduced the number of sea turtle takes, injuries, and deaths caused by scallop dredging. *Response:* The experimental fishery used two paired dredges, one equipped with a standard dredge and one equipped with a modified dredge. This paired design is an industry standard in gear work and is utilized to minimize unaccountable environmental variation. The study involved over 3000 paired hauls, which resulted in enough statistical power to be able to detect differences in the turtle catches between the modified and the unmodified dredge. There was a statistical difference between turtle catches in the control and modified dredges (at alpha - 0.05 level). NMFS recognizes that these studies relied on on-deck observations, and that sea turtles may be struck by the dredge while fishing near the bottom or while being hauled through the water column and not brought on-board. Unfortunately, these types of interactions cannot be quantified at this time because information on these interactions does not exist. However, the best available information does show that the chain mat modification prevents most, if not all, captures of sea turtles in the dredge bag; therefore preventing injuries that occur from such capture. *Comment 20:* One comment was received on the status of the loggerhead sea turtle. The commenter stated that the loggerhead sea turtle is no closer to recovery now than when it was originally listed and that the most recent data show that the number of loggerhead nests in Florida's Archie Carr National Wildlife Refuge has dropped precipitously from 1998 to 2004. *Response:* A detailed description of the status of the species can be found in the Environmental Assessment for this action, while a summary is provided here. A number of stock assessments (TEWG, 1998,2000; NMFS SEFSC 2001; Heppell *et al.* , 2003) have examined the stock status of loggerhead sea turtles in the waters of the United States, but have been unable to develop any reliable estimates of absolute population size. Due to the difficulty of conducting comprehensive population surveys away from nesting beaches, nesting beach survey data are used to index the status and trends of loggerhead sea turtles (68 FR 53949, Sept. 15, 2003). There are at least five western Atlantic loggerhead subpopulations. These are the south Florida, northern, Dry Tortugas, Florida Panhandle, and Yucatan subpopulations. Genetic analyses conducted at the nesting sites indicate that they are distinct subpopulations (TEWG, 2000). NMFS has concluded that the survival and recovery of each of these nesting subpopulations are critical to the survival and recovery of the species. While nesting beach data is a useful tool for assessing sea turtle populations, the detection of nesting trends requires consistent data collection methods over long periods of time (USFWS and NMFS, 2003). In 1989, a statewide sea turtle Index Nesting Beach Survey
(INBS)program was developed and implemented in Florida, and similar survey programs have been in implemented in Georgia, South Carolina, and North Carolina. Although not part of the INBS program, nesting survey data are also available for the Yucatan Peninsula, Mexico (USFWS and NOAA Fisheries 2003). However, the currently available nesting data is still too limited to indicate statistically reliable trends for these subpopulations. To date, analysis of nesting data from the INBS program through 2003 indicate that there is no discernable trend for the south Florida, northern, or Florida Panhandle subpopulations (68 FR 53949, September 15, 2003). Given the relatively short period of survey effort for the Dry Tortugas subpopulation, no conclusions can be made at this time on the trend of this subpopulation. Survey effort overall at the Yucatan nesting beaches has been inconsistent and no trend can be determined for this subpopulation given the currently available data (68 FR 53949, September 15, 2003). More reliable nesting trend information is available from some south Florida and northern subpopulation nesting beaches that have been surveyed for longer periods of times. Using the information gathered from these select south Florida and northern subpopulation nesting beaches, the Turtle Expert Working Group concluded that the south Florida subpopulation was increasing based on nesting data over the last couple of decades, and that the northern subpopulations was stable or declining (TEWG, 2000). Similar to other loggerhead nesting beaches, counts at Archie Carr National Wildlife decreased from 2001 through 2004. Preliminary data for 2005 indicates that loggerhead nest counts at Archie Carr increased from the 2004 counts (Florida Fish and Wildlife Conservation Commission, pers. comm., 2005). It should be recognized that this data is still preliminary and further analysis is needed. It is unknown at this time whether the overall nest counts represent an actual decline in the loggerhead subpopulations or not. Loggerhead sea turtles do exhibit a cyclical nesting pattern such that in some years nest counts are high while in others they are low. Natural events, such as the hurricanes of 2004, can also destroy many nests and affect nesting trends since a majority of the nests may be destroyed in any particular year. In addition, since nest counts are a reflection of only one sex and age class in the subpopulation (adult females), using nesting trend data to make conclusions about the status of an entire subpopulation requires making certain assumptions. These are that the current impacts to mature females are experienced to the same degree amongst all age classes regardless of sex and/or that the impacts that led to the current abundance of nesting females are affecting the current immature females to the same extent. There is no current evidence to support or refute these assumptions. In 2001, NMFS reviewed and updated the stock assessment for loggerhead sea turtles of the western North Atlantic, including information on nesting abundance and trends. The assessment also considered the impact of the U.S. pelagic longline fishery with and without the proposed changes in the Turtle Excluder Device
(TED)regulations for the shrimp fishery using a modified population model from Heppell *et al.*
(2003)to include new estimates of the duration of life stages and time at maturity and, unlike Heppell *et al.* (2003), also considered sex ratios other than 1:1 (NMFS SEFSC, 2001). A more detailed description of NMFS' assessment can be found in the supporting documents. Given the implementation of TED regulations to allow larger benthic immature and sexually mature loggerhead sea turtles to escape from shrimp trawl gear and given measures to increase pelagic immature survival by 10% have been implemented in the Highly Migratory Species fishery, loggerhead subpopulations in the western Atlantic should experience positive or at least stable growth as loggerheads in the various stage classes mature. These changes are unlikely to be evident in nesting beach censuses for many years given the late age at maturity for loggerhead sea turtles and the normal fluctuations in nesting. In-water population studies to measure abundance have also been conducted. Maier *et al.*
(2004)used fishery-independent trawl data to establish a regional index of abundance. The study was designed to concentrate on loggerhead sea turtles with emphasis on the northen subpopulation, and was conducted along the southeast coast of the United States (Winyah Bay, South Carolina to St. Augustine, FL) from 2000 2003. The loggerhead sea turtle was the dominant turtle collected during the study, with moderate levels of Kemp's ridley and a few green sea turtles encountered during the study. There was no significant difference for loggerheads in Catch per Unit Effort
(CPUE)among the years sampled. However, the annual mean CPUE did increase over the study period. The minimum rate of annual population change could not be detected within the four-year sampling period of the project. During the 4 years of the study, a disturbing trend of reduced catch rates in the smaller size classes was noted. Growth could account for a shift to larger size classes, but the observed decline in the percentages of sea turtles in the smallest size classes may indicate a recruitment failure. The pattern warrants continued observation. Maier *et al.*
(2004)found that a comparison of loggerhead catch data from this study with historical values suggests that in-water populations of loggerhead sea turtles along the southeastern United States appear to be larger, possibly an order of magnitude higher than they were 25 years ago. SEAMAP long-term data provides further support for the conclusion of increasing abundance of in-water loggerhead populations with catch rates increasing substantially since the early 1990s (Maier *et al.* , 2004). This type of regional abundance may be useful in examining long-term trends in overall turtle population status on a regional basis, but a number of inherent temporal, spatial, and, perhaps, environmental factors can affect catch rates and need to be recognized in developing a regional index of abundance. *Comment 21:* One commenter stated that there were two factors requiring the agency to reinitiate consultation. The first factor was Dr. Heppell's letter addressing the existing Biological Opinion. The second factor is the statement “Biological resources, in particular sea turtles, have been, are, and will continue to be negatively impacted by a variety of past, present, and future activities. These cumulative impacts may be impacting the recovery of the species, although the extent cannot be quantified” (draft EA, pg. 93). The commenter states that this is new information requiring reinitiation. *Response:* NMFS received a letter dated March 13, 2005 concerning the December 2004 Opinion on the Atlantic Sea Scallop FMP. The concerns raised in the letter were responded to by NMFS' Southeast Fisheries Science Center and were addressed in the litigation on the December 2004 Opinion. The letter does not trigger reinitiation. The cumulative impacts listed in the EA are not new information and were considered in the December 2004 Opinion. Therefore, that statement in the EA does not trigger reinitiation of the ESA Section 7 consultation on the Scallop Fishery. Classification The rule has been determined to be significant by the Office of Management and Budget for the purposes of Executive Order 12866. NMFS prepared an initial regulatory flexibility analysis for the proposed rule, which was described in the classification section of the preamble to the proposed rule. The public comment period ended on June 27, 2005. No comments were received on the economic impacts of the proposed action; one comment, as described above, was received on the economic impacts of non-preferred alternative 3 (seasonal closure). No changes were made as a result of such comments. NMFS has prepared a final regulatory flexibility analysis
(FRFA)that describes the economic impact this final rule would have on small entities. A description of the action, why it is being considered and the legal basis for this action are contained at the beginning of the preamble, in the SUMMARY , and in the FRFA. A summary of the analysis follows: The fishery affected by this final rule is the mid-Atlantic sea scallop dredge fishery. The action requires all vessels with a Federal Atlantic sea scallop fishery permit, regardless of dredge size of vessel permit category, to modify their dredge gear when fishing south of 41° 9.0′ N. latitude, from the shoreline to the outer boundary of the EEZ. According to Vessel Trip Report Data for 2003, 314 vessels fished in this area from May 1 through November 30. The economic analysis assumes that all 314 vessels are independently owned and operated. All 314 sea scallop dredge vessels are considered small entities. This final rule does not contain any additional reporting, recordkeeping, or other similar compliance requirements. The FRFA considered five alternatives. The preferred alternative (PA), non-preferred alternatives 1-3 (NPA 1-3), and the “no action” alternative. The PA, NPA 1-3, and the “no action” alternative were analyzed in the initial regulatory flexibility analysis and summarized in the proposed rule (70 FR 30660). NMFS selected the preferred alternative in the final rule (required the use of chain mats on all sea scallop dredges in the Mid-Atlantic from May through November 30) because this alternative would provide, with the exception of NPA 3 (seasonal closure of the mid-Atlantic), the most protection to sea turtles. The agency minimized impacts to small entities under this alternative by limiting the rule to the May through November time period and limiting the spatial extent to the mid-Atlantic. While NPA 1 (use of chain mats on all sea scallop dredges in the Mid-Atlantic from May 1 through October 15) may have had slightly reduced economic impacts compared to the PA, NMFS rejected NPA 1 because this alternative would leave sea turtles vulnerable to capture in the dredge bag from October 15 through November 30, a period when sea turtle distribution and sea scallop fishing overlap in the southern part of the fishery. While NPA 2 (use of chain mats on all large sea scallop dredges in the Mid-Atlantic from May through November 30) may have had slightly reduced economic impacts compared to the PA, NMFS rejected NPA 2 because this alternative would leave sea turtles vulnerable to capture in the dredge bag of smaller dredges operating in this area. Sea turtles have been documented taken in this smaller dredge gear. NMFS rejected NPA 3 (prohibit sea scallop dredge fishing south of 41° 9.0′ N. lat. from May 1 through November 30) because of the uncertainty of the extent of the area in which interactions are occurring, the broad extent of the closure, and the potential displacement of effort to other fishing areas. At this time, NMFS does not have sufficient information to further refine NPA 3 to limit the extent of the closure and rejected NPA 3, in part, because of the uncertainty regarding the extent of the area in which interactions between sea turtles and sea scallop dredge gear are occurring. NPA 3 would have had the highest economic impact. This final rule is consistent with the ESA and other applicable laws. Literature Cited Bass, A. L., S. P. Epperly, J. Braun-McNeill. 2004. Multi-year analysis of stock composition of a loggerhead sea turtle ( *Caretta caretta* ) foraging habitat using maximum likelihood and Bayesian methods. Conservation Genetics. 5:783-796. CeTAP (Cetacean and Turtle Assessment Program). 1982. Final report on the cetacean and turtle assessment program. University of Rhode Island to Bureau of Land Management, U.S. Department of the Interior. Ref. No. AA551-CT8-48. 568 pp. DeGroot, K. A. and J. H. Shaw. 1993. Nesting activities by the loggerhead ( *Caretta caretta* ) at Back Bay National Wildlife Reguge, VA. Proceedings of the Oklahoma Academy of Science. 73:15-17. Heppell, S. S., L. B. Crowder, D. T. Crouse, S. P. Epperly, and N.B. Frazer. 2003. Population models for Atlantic loggerheads: past, present, and future. In A.B. Bolten and B. E. Witherington (editors) Loggerhead sea turtles. Smithsonian Institute, Washington, D.C. pp. 255-273 Keinath, J. A., J. A. Musick, and R. A. Byles. 1987. Aspects of the biology of Virginia's sea turtles: 1979-1986. Virginia J. Sci. 38(4):329-336. Lutcavage, M. E. And J. A. Musick. 1985. Aspects of the biology of sea turtles in Virginia. Copeia. 2:449-456. Maier, P. P., A. L. Segars, M. D. Arendt, J. D. Whitaker, B. W. Stender, L. Parker, R. Vendetti, D. W. Owens, J. Quattro, and S. R. Murphy. 2004. Development of an index of sea turtle abundance based on in-water sampling with trawl gear. Final report to the National Marine Fisheries Service. 86 pp. Mitchell, G. H., R. D. Kenney, A. M. Farak, R. J. Campbell. 2003. Evaluation of occurrence of endangered and threatened marine species in naval ship trial areas and transit lanes in the Gulf of Maine and offshore of Georges Bank. Naval Undersea Warfare Center Division Newport, Rhode Island. NUWC-NPT Technical Memo 0-121A. 113 pp. Morreale, S. J. and E. A. Standora. 1998. Early life stage ecology of sea turtles in northeastern U.S. waters. U.S. Dep. Commer. NOAA Tech. Mem. NMFS-SEFSC-413. 49pp. Morreale, S. J. and E. A. Standora. 1993. Occurrence, movement, and behavior of the Kemp's ridley and other sea turtles in New York waters. Final Report April 1988 - March 1993. 70 pp. Morreale, S. J. and E. A. Standora. 2005. Western North Atlantic waters: Critical developmental habitat for Kemp's ridley and loggerhead sea turtles. Chelonian Conservation and Biology. 4(4)872-882. Murray, K. T. 2004. Bycatch of sea turtles in the mid-Atlantic sea scallop ( *Placopecten magellanicus* ) dredge fishery during 2003. 2nd ed. U.S. Dep Commer., Northeast Fisheries Science Center Reference Document 04-11. Northeast Fisheries Science Center. Woods Hole, MA. 25 pp. Murray, K. T. 2005. Total bycatch estimate of loggerhead turtles ( *Caretta caretta* ) in the 2004 Atlantic sea scallop ( *Placopecten magellanicus* ) dredge fishery. U.S. Dep Commer., Northeast Fisheries Science Center Reference Document 05-12. Northeast Fisheries Science Center. Woods Hole, MA. 22 pp. NMFS (National Marine Fisheries Service). 1994. State and federal fishery interactions with sea turtles in the mid-Atlantic area. NOAA/NMFS, Silver Spring, MD. 13 pp. NMFS SEFSC (National Marine Fisheries Service Southeast Fisheries Science Center). 2001. Stock assessments of loggerhead and leatherback sea turtles and an assessment of the impact of the pelagic longline fishery on the loggerhead and leatherback sea turtles of the Western North Atlantic. U.S. Dep. Commer. NMFS, Miami, Fl, SEFSC Contribution PRD 00/01-08; Parts I-III and Appendices I-IV. NOAA Tech. Mem. NMFS-SEFSC-455, 343 pp. Plotkin P. T. and J. R. Spotila. 2002. Post nesting migrations of loggerhead turtles, *Caretta caretta* , from Georgia, USA: conservation implications for a genetically distinct subpopulation. Oryx. 36(4):396-399. Shoop, C. R. 1980. Sea turtles in the Northeast. Maritimes 24:9-11. Shoop, C. R. and R. D. Kenney. 1992. Seasonal distributions and abundance of loggerhead and leatherback sea turtles in waters of the northeastern United States. Herpetol. Monogr. 6:43-67. Spotila, J. R., P. T. Plotkin, and J. A. Keinath. 1998. In water population survey of sea turtles of Delaware Bay. Unpublished report. Final Report to NMFS Office of Protected Resource for work conducted under Contract No. 43AANF600211 and NMFS Permit no. 1007 by Drexel University, Philadelphia, PA. 21 pp. Teas, W. G. 1993. Species composition and size class distribution of marine turtle strandings on the Gulf of Mexico and southeast United States coasts, 1985-1991. NOAA Tech. Memo. NMFS-SERFSC-315. 43pp. TEWG (Turtle Expert Working Group). 1998. An assessment update for the Kemp's ridley ( *Lepidochelys kempii* ) and loggerhead ( *Caretta caretta* ) sea turtle populations in the western North Atlantic. U.S. Dep. Commer. NOAA Tech Memo. NMFS-SEFSC-409 96 pp. TEWG (Turtle Expert Working Group). 2000. An assessment update for the Kemp's ridley and loggerhead sea turtle populations in the western North Atlantic. U.S. Dep. Commer. NOAA Tech Memo. NMFS-SEFSC-444, 115 pp. USFWS (United States Fish and Wildlife Service). 2004. Loggerhead sea turtle (Caretta caretta). Fact Sheet. USFWS North Florida Field Office. Available at *http://northflorida.fws.gov/SeaTurtles/Turtle%20Factsheets/loggerhead-sea-turtle-htm.* 3 pp. White, M. 2004. Observations of loggerhead sea turtles feeding on discarded fish catch at Argostoli, Kefalonia. Marine Turtle Newsletter. 105:7-9. Wynne, K. and M. Schwartz. 1999. Guide to marine mammals and turtles of the U.S. Atlantic and Gulf of Mexico. Rhode Island Sea Grant. Narragansett, RI. 115 pp. List of Subjects in 50 CFR Parts 222 and 223 Endangered and threatened species, Exports, Imports. Dated: August 18, 2006. Samuel D. Rauch, III Deputy Assistant Administrator for Regulatory Programs, National Marine Fisheries Service. PART 222—GENERAL ENDANGERED AND THREATENED MARINE SPECIES For the reasons set forth in the preamble, 50 CFR part 222 and 223 are to be amended as follows: 1. The authority citation for part 222 continues to read as follows: Authority: 16 U.S.C. 1531 *et seq.* ; 16 U.S.C. 742a *et seq.* ; 31 U.S.C. 9701. 2. In § 222.102, the definition of “Chain mat” and “Dredge or dredge gear” are added in alphabetical order to read as follows: § 222.102 Definitions. *Chain mat* means a device designed to be installed in a scallop dredge forward of the sweep, as described in 50 CFR 223.206, for the purpose of excluding sea turtles from the dredge. *Dredge or dredge gear* , with respect to the fishery operating under the Atlantic Sea Scallop Fishery Management Plan, means gear consisting of a mouth frame attached to a holding bag constructed of metal rings, or any other modification to this design, that can be or is used in the harvest of sea scallops. PART 223—THREATENED MARINE AND ANADROMOUS SPECIES 1. The authority citation for part 223 continues to read as follows: Authority: 16 U.S.C. 1531-1543; subpart B, § 223.12 also issued under 16 U.S.C. 1361 *et seq.* ; 16 U.S.C. 5503(d) for § 223.206(d)(9). 2. In § 223.205, paragraph (b)(16) is redesignated as (b)(17); paragraph (b)(15) is revised and new paragraph (b)(16) is added to read as follows: § 223.205 Sea turtles.
(b)* * *
(15)Fail to comply with the restrictions set forth in § 223.206(d)(10) regarding pound net leaders;
(16)Fail to comply with the restrictions set forth in § 223.206(d)(11) regarding sea scallop dredges; or 3. In § 223.206, paragraph
(d)introductory text is revised and paragraph (d)(11) is added to read as follows: § 223.206 Exemptions to prohibitions relating to sea turtles.
(d)Exception for incidental taking. The prohibitions against taking in § 223.205(a) do not apply to the incidental take of any member of a threatened species of sea turtle (i.e., a take not directed towards such member) during fishing or scientific research activities, to the extent that those involved are in compliance with all applicable requirements of paragraphs (d)(1) through (d)(11) of this section, or in compliance with the terms and conditions of an incidental take permit issued pursuant to paragraph (a)(2) of this section.
(11)Restrictions applicable to sea scallop dredges in the mid-Atlantic—(i) Gear Modification. During the time period of May 1 through November 30, any vessel with a sea scallop dredge and required to have a Federal Atlantic sea scallop fishery permit, regardless of dredge size or vessel permit category, present in waters south of 41° 9.0′ N. lat., from the shoreline to the outer boundary of the Exclusive Economic Zone must have on each dredge a chain mat described as follows. The chain mat must be composed of “tickler” (horizontal) chains and “vertical” chains that are evenly spaced and configured in the following manner dependent on the dredge width: Dredges with a frame width of greater than 13 ft (3.96 m) must use 11 vertical and 6 tickler chains; dredges with a frame width of 11 ft to 13 ft (3.35-3.96 m) must use 9 vertical and 5 tickler chains; dredges with a frame width of 10 ft (3.05 m) to less than 11 ft (3.35 m) must use 7 vertical and 4 tickler chains; dredges with a frame width of less than 10 ft (3.05 m) must use 5 vertical and 3 tickler chains. The tickler and vertical chains must be connected to each other with a shackle or link at the intersection point. If a vessel elects to use a different configuration, the length of each side of the square or rectangle formed by the intersecting chains must be less than or equal to 14 inches (35.5 cm). The chains must be connected to each other with a shackle or link at each intersection point. The measurement must be taken along the chain, with the chain held taut, and include one shackle or link at the intersection point and all links in the chain up to, but excluding, the shackle or link at the other intersection point.
(ii)Any vessel that harvests sea scallops in or from the waters described in (d)(11)(i) and that is required to have a Federal Atlantic sea scallop fishery permit must have the chain mat configuration installed on all dredges for the duration of the trip. [FR Doc. 06-7160 Filed 8-24-06; 8:45 am]
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