Tetrachlorvinphos; Proposed Extension of Time-Limited Interim Pesticide Tolerances, 33184-33188 [2011-14211]

Download as PDF 33184 Federal Register / Vol. 76, No. 110 / Wednesday, June 8, 2011 / Proposed Rules (703) 308–8715; e-mail address: mendelsohn.mike@epa.gov. SUPPLEMENTARY INFORMATION: I. General Information A. Does this action apply to me? You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to: • Crop production (NAICS code 111). • Animal production (NAICS code 112). • Food manufacturing (NAICS code 311). • Pesticide manufacturing (NAICS code 32532). This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT. jlentini on DSK4TPTVN1PROD with PROPOSALS B. What Should I Consider as I Prepare My Comments for EPA? 1. Submitting CBI. Do not submit this information to EPA through regulations.gov or e-mail. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD–ROM that you mail to EPA, mark the outside of the disk or CD–ROM as CBI and then identify electronically within the disk or CD–ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. 2. Tips for preparing your comments. When submitting comments, remember to: i. Identify the document by docket ID number and other identifying information (subject heading, Federal Register date and page number). ii. Follow directions. The Agency may ask you to respond to specific questions or organize comments by referencing a VerDate Mar<15>2010 17:24 Jun 07, 2011 Jkt 223001 Code of Federal Regulations (CFR) part or section number. iii. Explain why you agree or disagree; suggest alternatives and substitute language for your requested changes. iv. Describe any assumptions and provide any technical information and/ or data that you used. v. If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced. vi. Provide specific examples to illustrate your concerns and suggest alternatives. vii. Explain your views as clearly as possible, avoiding the use of profanity or personal threats. viii. Make sure to submit your comments by the comment period deadline identified. 3. Environmental justice. EPA seeks to achieve environmental justice, the fair treatment and meaningful involvement of any group, including minority and/or low-income populations, in the development, implementation, and enforcement of environmental laws, regulations, and policies. To help address potential environmental justice issues, the Agency seeks information on any groups or segments of the population who, as a result of their location, cultural practices, or other factors, may have atypical or disproportionately high and adverse human health impacts or environmental effects from exposure to the pesticides discussed in this document, compared to the general population. In accordance with 40 CFR 180.7(f), a summary of the petition that is the subject of this document, prepared by the petitioner, is included in a docket EPA has created for this rulemaking. The docket for this petition is available on-line at https://www.regulations.gov. As required by FFDCA section 408(d)(3), (21 U.S.C. 346a(d)(3)), EPA is publishing notice of the petition so that the public has an opportunity to comment on this request for the establishment or modification of regulations for residues of pesticides in or on food commodities. Further information on the petition may be obtained through the petition summary referenced in this unit. II. What action is the Agency taking? List of Subjects in 40 CFR Part 174 Environmental protection, Agricultural commodities, Feed additives, Food additives, Pesticides and pests, Reporting and recordkeeping requirements. EPA is announcing receipt of a pesticide petition filed under section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, requesting the establishment or modification of regulations in 40 CFR part 174 or part 180 for residues of pesticide chemicals in or on various food commodities. The Agency is taking public comment on the request before responding to the petitioner. EPA is not proposing any particular action at this time. EPA has determined that the pesticide petition described in this document contains data or information prescribed in FFDCA section 408(d)(2); however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data supports granting of the pesticide petition. After considering the public comments, EPA intends to evaluate whether and what action may be warranted. Additional data may be needed before EPA can make a final determination on this pesticide petition. PO 00000 Frm 00012 Fmt 4702 Sfmt 4702 Amended Tolerance Exemption PP1G7868. Syngenta Seeds Inc., P.O. Box 12257, Research Triangle Park, North Carolina 27709, proposes to extend an exemption from the requirement of a tolerance for residues of the plant-incorporated protectant, Bacillus thuringiensis eCry3.1Ab protein in corn, in or on the food and feed commodities of corn; corn, field; corn, sweet; and corn, pop under 40 CFR 174.532; March 16, 2011; 76 FR 14289 (FRL–8866–5) when Bacillus thuringiensis eCry3.1Ab protein in corn is used as a plant-incorporated protectant in accordance with the terms of Experimental Use Permit 67979– EUP–8. The petitioner believes no analytical method is needed because a temporary exemption from the requirement of a tolerance is being sought. Dated: May 24, 2011. Keith A. Matthews, Director, Biopesticides and Pollution Prevention Division, Office of Pesticide Programs. [FR Doc. 2011–14190 Filed 6–7–11; 8:45 am] BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA–HQ–OPP–2011–0360; FRL–8874–7] Tetrachlorvinphos; Proposed Extension of Time-Limited Interim Pesticide Tolerances Environmental Protection Agency (EPA). AGENCY: E:\FR\FM\08JNP1.SGM 08JNP1 Federal Register / Vol. 76, No. 110 / Wednesday, June 8, 2011 / Proposed Rules ACTION: Proposed rule. This document proposes the extension of time-limited interim tolerances for the combined residues of the insecticide tetrachlorvinphos (Z)-2chloro-1-(2,4,5-trichlorophenyl) vinyl dimethyl phosphate, including its metabolites, 1-(2,4,5-trichlorophenyl)ethanol (free and conjugated forms), 2,4,5-trichloroacetophenone, and 1(2,4,5-trichlorophenyl)-ethanediol, in or on multiple commodities which will be identified later in this document, under the Federal Food, Drug, and Cosmetic Act (FFDCA). DATES: Comments, identified by docket identification (ID) number EPA–HQ– OPP–2011–0360, must be received on or before August 8, 2011. ADDRESSES: Submit your comments, identified by docket ID number EPA– HQ–OPP–2011–0360, by one of the following methods: • Federal eRulemaking Portal: https:// www.regulations.gov. Follow the on-line instructions for submitting comments. • Mail: Tetrachlorvinphos; Proposed Extension of Time-Limited Interim Pesticides, Office of Pesticide Programs (OPP) Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460–0001. • Delivery: OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S–4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only accepted during the Docket Facility’s normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket Facility telephone number is (703) 305–5805. Instructions: Direct your comments to docket ID number EPA–HQ–OPP–2011– 0360. EPA’s policy is that all comments received will be included in the docket without change and may be made available on-line at https:// www.regulations.gov, including any personal information provided, unless the comment includes information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through regulations.gov or email. The regulations.gov Web site is an ‘‘anonymous access’’ system, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an e-mail comment directly to EPA without going through jlentini on DSK4TPTVN1PROD with PROPOSALS SUMMARY: VerDate Mar<15>2010 17:51 Jun 07, 2011 Jkt 223001 regulations.gov, your e-mail address will be automatically captured and included as part of the comment that is placed in the docket and made available on the Internet. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD–ROM you submit. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses. Docket: All documents in the docket are listed in the docket index available at https://www.regulations.gov. Although listed in the index, some information is not publicly available, e.g., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available either in the electronic docket at https:// www.regulations.gov, or, if only available in hard copy, at the OPP Regulatory Public Docket in Rm. S– 4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The hours of operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket Facility telephone number is (703) 305–5805. FOR FURTHER INFORMATION CONTACT: Carmen Rodia, Registration Division (7504P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Avenue, NW., Washington, DC 20460–0001; telephone number: (703) 306–0327; fax number: (703) 308–0029; e-mail address: rodia.carmen@epa.gov. SUPPLEMENTARY INFORMATION: I. General Information A. Does this action apply to me? You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to: • Crop production (NAICS code 111). • Animal production (NAICS code 112). • Food manufacturing (NAICS code 311). • Pesticide manufacturing (NAICS code 32532). This listing is not intended to be exhaustive, but rather provides a guide PO 00000 Frm 00013 Fmt 4702 Sfmt 4702 33185 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. What should I consider as I prepare my comments for EPA? 1. Submitting CBI. Do not submit this information to EPA through regulations.gov or e-mail. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD–ROM that you mail to EPA, mark the outside of the disk or CD–ROM as CBI and then identify electronically within the disk or CD–ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. 2. Tips for preparing your comments. When submitting comments, remember to: i. Identify the document by docket ID number and other identifying information (subject heading, Federal Register date and page number). ii. Follow directions. The Agency may ask you to respond to specific questions or organize comments by referencing a Code of Federal Regulations (CFR) part or section number. iii. Explain why you agree or disagree; suggest alternatives and substitute language for your requested changes. iv. Describe any assumptions and provide any technical information and/ or data that you used. v. If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced. vi. Provide specific examples to illustrate your concerns and suggest alternatives. vii. Explain your views as clearly as possible, avoiding the use of profanity or personal threats. viii. Make sure to submit your comments by the comment period deadline identified. E:\FR\FM\08JNP1.SGM 08JNP1 33186 Federal Register / Vol. 76, No. 110 / Wednesday, June 8, 2011 / Proposed Rules jlentini on DSK4TPTVN1PROD with PROPOSALS II. Background Following the enactment of the Food Quality Protection Act of 1996 (FQPA), EPA reviewed and assessed under the new FQPA aggregate risk standard, the existing tolerances of 31 organophosphates (OPs), including tetrachlorvinphos (TCVP). In late December 2002, EPA reported the results of its assessment of TCVP tolerances in its Tolerance Reassessment Eligibility Decision (TRED) document, (67 FR 77491, December 18, 2002) (FRL–7279–2). The TCVP TRED concluded that the TCVP livestock residue studies were not adequate, and recommended that the Agency require the registrant to conduct and submit new magnitude of residue (MOR) studies to support permanent TCVP tolerances. The TCVP TRED also recommended the Agency revoke 4 existing tolerances in commodities supporting TCVP uses that were no longer registered. Finally, the TRED recommended that the Agency use existing TCVP metabolism studies to modify 5 existing livestock tolerances (fat of cattle, hogs and poultry as well as eggs and milk fat) and establish 11 tolerances for additional tissues of cattle, hogs and poultry (such as meat, meat byproducts and kidney and liver). Specifically, the TRED recommended that EPA establish 16 TCVP tolerances as ‘‘time-limited for a period of 18 months * * * to permit sufficient time for the registrant to submit the required MOR studies.’’ TCVP TRED at 41. On February 6, 2004, EPA issued a Generic Data Call-In Notice requiring the registrant to conduct and submit new livestock MOR studies for meat, milk, poultry, and eggs. On February 6, 2008, pursuant to section 408(e) of the FFDCA, EPA proposed to revoke, modify and establish tolerances for 10 pesticides, including TCVP (73 FR 6867) (FRL– 8345–2). EPA explained that the proposed tolerance actions were a ‘‘follow-up to the Agency reregistration program under Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and tolerance reassessment program under FFDCA section 408(q).’’ Id. As such, EPA proposed to implement the tolerance recommendations made in the TCVP TRED by: (1) Revising the tolerance expression in 40 CFR 180.252 to regulate the residues of TCVP and its metabolites; (2) Revise and establish 16 timelimited TCVP livestock tolerances to reflect levels of TCVP and its metabolites in various metabolism studies; and VerDate Mar<15>2010 17:24 Jun 07, 2011 Jkt 223001 (3) Revoke tolerances for residues of TCVP for goat fat and horse fat. Specifically, EPA proposed to establish the 16 TCVP tolerances for ‘‘18 months to permit time for the submission of additional MOR data to support permanent tolerances.’’ (73 FR 6867, February 6, 2008). Because the Agency was taking action to establish tolerances in/on beef cattle, hog and poultry commodities, EPA determined that the exception that permitted the use of TCVP as an additive to beef cattle, dairy cattle, horse and swine feed at certain rates was no longer necessary. On September 17, 2008, EPA finalized the rule as proposed, establishing, among other things, 16 time-limited tolerances for TCVP with an expiration date of March 17, 2010 (73 FR 53732) (FRL– 8375–2). For both the proposal and the final rule, EPA determined that the ‘‘increased tolerances and new tolerances to be established are safe; i.e., there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue.’’ (73 FR 53732, September 17, 2008). It was EPA’s intention that upon submission of the required TCVP MOR studies, the time-limited tolerances would be extended to allow EPA sufficient time to review the data with the expectation that the data would support the establishment of permanent tolerances. Prior to March 17, 2010, the registrant did in fact submit MOR data in cattle (MRID 47193001), MOR data in poultry (MRID 47589301), and the livestock validation methodology (MRID 47369201). However, due to a mistake on the part of EPA, the data were not reviewed in a timely manner. Compounding this error, EPA also failed to extend the time-limited tolerances to allow for the Agency to review the data and make a determination with respect to converting the time-limited tolerances into permanent tolerances. Accordingly, in order to remedy the Agency’s mistake and to be consistent with its original proposal and final rule establishing the TCVP time-limited tolerances, EPA is proposing to extend the expired time-limited tolerances for another 18 months to allow EPA to review the livestock MOR data submitted by the registrant as well as subsequent submissions, including storage stability data (MRID 47589301) to support the previously submitted MOR data in poultry, storage stability data (MRID 48378101) to support the previously submitted MOR data in cattle, and a waiver request for MOR data in swine. In the TCVP TRED, EPA ‘‘found that, apart from consideration of the potential PO 00000 Frm 00014 Fmt 4702 Sfmt 4702 cumulative risks from all of the OPs, each of the tolerances would meet the FFDCA safety standard. EPA has not considered the impact of these cumulative risks in the reassessment of these tolerances and has determined that these tolerances make, at most, only a negligible contribution to the overall risks from OPs. Therefore, these tolerances can be maintained regardless of the outcome of the OP cumulative assessment and any potential regulatory action taken as a result of that assessment. Accordingly, EPA ‘‘believes it is appropriate to consider these tolerances reassessed for the purposes of section 408(q) of FQPA as of July 23, 2002.’’ (67 FR 52985, August 14, 2002) (FRL–7192–4). Among the factors EPA considered in making the decision to reassess these tolerances were extensive livestock feeding/metabolism studies as well as extensive monitoring data that was in agreement with the livestock feeding/ metabolisms studies. In sum, there were very few detectable residues in the OP monitoring data for animal commodities. EPA relied upon extensive monitoring data from the U.S. Department of Agriculture’s (USDA) Pesticide Data Program (PDP) and U.S. Food and Drug Administration’s (FDA) Total Diet Study (TDS) covering residues of multiple OPs in meats and poultry. The residue monitoring data showed infrequent detections, and those residues were detected at low levels. Out of approximately 400 meat samples analyzed by the TDS for multiple OPs from 1991–1999, only 9 samples detected any OP residues (the residues ranged between 0.002 ppm and 0.009 ppm). Out of the approximately 500 poultry samples analyzed by PDP for multiple OPs from 1997–2000, only 1 sample detected an OP residue (0.01 ppm) for a pesticide that currently has a tolerance. Id. For milk and eggs, extensive monitoring data were available from USDA’s PDP and FDA’s TDS. The residue monitoring data showed no detectable OP residues in milk (there was only 1 trace sample detected out of approximately 1,800 samples analyzed by PDP for multiple OPs from 1996–1998). The residue monitoring for eggs also showed no detectable OP residues (only 1 trace sample was detected out of approximately 1,300 samples analyzed by TDS for multiple OPs from 1992– 1998). Id. In July of 2006, EPA completed the OP cumulative risk assessment (CRA), using the best available monitoring data. The updated USDA PDP data indicated that OP residues would not be expected to occur in significant amounts in meat E:\FR\FM\08JNP1.SGM 08JNP1 Federal Register / Vol. 76, No. 110 / Wednesday, June 8, 2011 / Proposed Rules jlentini on DSK4TPTVN1PROD with PROPOSALS or milk. The analysis in the OP CRA indicated that animal commodities do not significantly contribute to OP dietary exposure and total OP dietary risk. This characterization was supported by additional information, including the updated TDS data. On July 31, 2006, EPA finalized the TCVP reregistration eligibility determination by concluding that the pesticide tolerances covered by the IREDs and TREDs that were pending the result of the OP CRA—including TCVP tolerances, meet the safety standard under section 408(b)(2) of the FFDCA. In 2008, EPA confirmed that USDA PDP analyses of livestock commodities, including milk, poultry, pork, and beef, through 2005 showed virtually no detectable residues of TCVP (except for 2 lone milk samples detected at levels just above the LOQ (less than one part per billion), detected out of approximately 5,200 samples analyzed by PDP for multiple OPs from 2001– 2005. Furthermore, the USDA Food Safety and Inspection Service (FSIS) monitors meat for residues of tetrachlorvinphos, and there have been no detections of tetrachlorvinphos from 2000–2009. III. Proposal EPA on its own initiative, under section 408(e) of the FFDCA, 21 U.S.C. 346a(e), is proposing to extend the dates of expiration/revocation for the timelimited interim tolerances for the combined residues of the insecticide tetrachlorvinphos (Z)-2-chloro-1-(2,4,5trichlorophenyl) vinyl dimethyl phosphate, including its metabolites, 1(2,4,5-trichlorophenyl)-ethanol (free and conjugated forms), 2,4,5trichloroacetophenone, and 1-(2,4,5trichlorophenyl)-ethanediol, in or on cattle, fat (of which no more than 0.1 ppm is tetrachlorvinphos per se) at 0.2 parts per million (ppm); cattle, kidney (of which no more than 0.05 ppm is tetrachlorvinphos per se) at 1.0 ppm; cattle, liver (of which no more than 0.05 ppm is tetrachlorvinphos per se) at 0.5 ppm; cattle, meat (of which no more than 2.0 ppm is tetrachlorvinphos per se) at 2.0 ppm; cattle, meat byproducts, except kidney and liver at 1.0 ppm; egg (of which no more than 0.05 ppm is tetrachlorvinphos per se) at 0.2 ppm; hog, fat (of which no more than 0.1 ppm is tetrachlorvinphos per se) at 0.2 ppm; hog, kidney (of which no more than 0.05 ppm is tetrachlorvinphos per se) at 1.0 ppm; hog, liver (of which no more than 0.05 ppm is tetrachlorvinphos per se) at 0.5 ppm; hog, meat (of which no more than 2.0 ppm is tetrachlorvinphos per se) at 2.0 ppm; hog, meat byproducts, except kidney and liver at 1.0 ppm; VerDate Mar<15>2010 17:51 Jun 07, 2011 Jkt 223001 milk, fat (reflecting negligible residues in whole milk and of which no more than 0.05 ppm is tetrachlorvinphos per se) at 0.05 ppm; poultry, fat (of which no more than 7.0 ppm is tetrachlorvinphos per se) at 7.0 ppm; poultry, liver (of which no more than 0.05 ppm is tetrachlorvinphos per se) at 2.0 ppm; poultry, meat (of which no more than 3.0 ppm is tetrachlorvinphos per se) at 3.0 ppm; and poultry, meat byproducts, except liver at 2.0 ppm, for a period of 18 months following the date of publication of the final rule in the Federal Register, in order to provide the Agency with additional time to complete the reviews of the submitted livestock MOR data, storage stability data, and the waiver request for the swine MOR data. IV. Statutory and Executive Order Reviews This proposed rule establishes a tolerance under section 408(e) of FFDCA. 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 proposed rule has been exempted from review under Executive Order 12866 due to its lack of significance, this proposed rule is not subject to Executive Order 13211, entitled Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001). This proposed rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 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 are being established under section 408(e) of the FFDCA, such as the tolerance in this proposed rule, do not PO 00000 Frm 00015 Fmt 4702 Sfmt 4702 33187 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. The Agency hereby certifies that this proposed action will not have significant negative economic impact on a substantial number of small entities. In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure ‘‘meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.’’ ‘‘Policies that have federalism implications’’ is defined in the Executive order to include regulations that have ‘‘substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.’’ This proposed rule directly regulates growers, food processors, food handlers, and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of the FFDCA. For these same reasons, the Agency has determined that this proposed rule does not have any ‘‘Tribal implications’’ as described in Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 9, 2000). Executive Order 3175 requires EPA to develop an accountable process to ensure ‘‘meaningful and timely input by Tribal officials in the development of regulatory policies that have Tribal implications.’’ ‘‘Policies that have Tribal implications’’ is defined in the Executive order to include regulations that have ‘‘substantial direct effects on one or more Indian Tribes, on the relationship between the Federal Government and the Indian Tribes, or on the distribution of power and responsibilities between the Federal Government and Indian Tribes.’’ This proposed rule will not have substantial direct effects on Tribal governments, on the relationship between the Federal Government and Indian Tribes, or on the distribution of power and responsibilities between the Federal Government and Indian Tribes, as E:\FR\FM\08JNP1.SGM 08JNP1 33188 Federal Register / Vol. 76, No. 110 / Wednesday, June 8, 2011 / Proposed Rules specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this proposed rule. List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: May 26, 2011. Lois Rossi, Director, Registration Division, Office of Pesticide Programs. Therefore, it is proposed that 40 CFR chapter I be amended as follows: PART 180—[AMENDED] 1. The authority citation for part 180 continues to read as follows: Authority: 21 U.S.C. 321(q), 346a and 371. 2. Section 180.252 is revised to read as follows: Parts per million Commodity Cattle, fat (of which no more than 0.1 ppm is tetrachlorvinphos per se). Cattle, kidney (of which no more than 0.05 ppm is tetrachlorvinphos per se). Cattle, liver (of which no more than 0.05 ppm is tetrachlorvinphos per se). Cattle, meat (of which no more than 2.0 ppm is tetrachlorvinphos per se). Cattle, meat byproducts, except kidney and liver ........................ Egg (of which no more than 0.05 ppm is tetrachlorvinphos per se). Hog, fat (of which no more than 0.1 ppm is tetrachlorvinphos per se). Hog, kidney (of which no more than 0.05 ppm is tetrachlorvinphos per se). Hog, liver (of which no more than 0.05 ppm is tetrachlorvinphos per se). Hog, meat (of which no more than 2.0 ppm is tetrachlorvinphos per se). Hog, meat byproducts, except kidney and liver .......................... Milk, fat (reflecting negligible residues in whole milk and of which no more than 0.05 ppm is tetrachlorvinphos per se). Poultry, fat (of which no more than 7.0 ppm is tetrachlorvinphos per se). Poultry, liver (of which no more than 0.05 ppm is tetrachlorvinphos per se). Poultry, meat (of which no more than 3.0 ppm is tetrachlorvinphos per se). Poultry, meat byproducts, except liver ......................................... (b) Section 18 emergency exemptions. [Reserved] (c) Tolerances with regional registrations. [Reserved] (d) Indirect or inadvertent residues. [Reserved] [FR Doc. 2011–14211 Filed 6–7–11; 8:45 am] BILLING CODE 6560–50–P 0.2 [date 18 months from the date of Final tolerance publication]. 1.0 [date 18 months from the date of Final tolerance publication]. 0.5 [date 18 months from the date of Final tolerance publication]. 2.0 [date 18 months from the date of Final tolerance publication]. 1.0 0.2 [date 18 months from the date of Final tolerance publication]. [date 18 months from the date of Final tolerance publication]. 0.2 [date 18 months from the date of Final tolerance publication]. 1.0 [date 18 months from the date of Final tolerance publication]. 0.5 [date 18 months from the date of Final tolerance publication]. 2.0 [date 18 months from the date of Final tolerance publication]. 1.0 0.05 [date 18 months from the date of Final tolerance publication]. [date 18 months from the date of Final tolerance publication]. 7.0 [date 18 months from the date of Final tolerance publication]. 2.0 [date 18 months from the date of Final tolerance publication]. 3.0 [date 18 months from the date of Final tolerance publication]. 2.0 [date 18 months from the date of Final tolerance publication]. DEPARTMENT OF HEALTH AND HUMAN SERVICES 42 CFR Part 84 [Docket Number NIOSH–109] RIN 0920–AA04 Quality Assurance Requirements for Respirators; Notice of Withdrawal Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS). ACTION: Notice of proposed rulemaking; withdrawal. jlentini on DSK4TPTVN1PROD with PROPOSALS The Department of Health and Human Services (HHS) is withdrawing its proposed rule to update the quality assurance and control requirements for the manufacture of respirators approved under 42 CFR Part 84 by the National SUMMARY: 17:24 Jun 07, 2011 Jkt 223001 PO 00000 Frm 00016 (a) General. Tolerances are established for the combined residues of the insecticide tetrachlorvinphos (Z)-2chloro-1-(2,4,5-trichlorophenyl) vinyl dimethyl phosphate, including its metabolites, 1-(2,4,5-trichlorophenyl)ethanol (free and conjugated forms), 2,4,5-trichloroacetophenone, and 1(2,4,5-trichlorophenyl)-ethanediol, in or on the following commodities: Expiration/revocation date AGENCY: VerDate Mar<15>2010 § 180.252 Tetrachlorvinphos; tolerances for residues. Fmt 4702 Sfmt 4702 Institute for Occupational Safety and Health (NIOSH), Centers for Disease Control and Prevention and the Mine Safety and Health Administration (MSHA). NIOSH has reviewed the comments it received to the proposed rule and determined that additional analysis is needed to assess the economic impact of its proposed rule. NIOSH plans to seek further information and to consider possible alternative approaches. The proposed rule published on December 10, 2008 (73 FR 75045) will be withdrawn as of June 8, 2011. DATES: FOR FURTHER INFORMATION CONTACT: William Newcomb, NIOSH National Personal Protective Technology Laboratory (NPPTL), P.O. Box 18070, 626 Cochrans Mill Road, Pittsburgh, PA 15236, telephone (412) 386–4034 (this is E:\FR\FM\08JNP1.SGM 08JNP1

Agencies

[Federal Register Volume 76, Number 110 (Wednesday, June 8, 2011)]
[Proposed Rules]
[Pages 33184-33188]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-14211]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2011-0360; FRL-8874-7]


Tetrachlorvinphos; Proposed Extension of Time-Limited Interim 
Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

[[Page 33185]]


ACTION: Proposed rule.

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SUMMARY: This document proposes the extension of time-limited interim 
tolerances for the combined residues of the insecticide 
tetrachlorvinphos (Z)-2-chloro-1-(2,4,5-trichlorophenyl) vinyl dimethyl 
phosphate, including its metabolites, 1-(2,4,5-trichlorophenyl)-ethanol 
(free and conjugated forms), 2,4,5-trichloroacetophenone, and 1-(2,4,5-
trichlorophenyl)-ethanediol, in or on multiple commodities which will 
be identified later in this document, under the Federal Food, Drug, and 
Cosmetic Act (FFDCA).

DATES: Comments, identified by docket identification (ID) number EPA-
HQ-OPP-2011-0360, must be received on or before August 8, 2011.

ADDRESSES: Submit your comments, identified by docket ID number EPA-HQ-
OPP-2011-0360, by one of the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Mail: Tetrachlorvinphos; Proposed Extension of Time-
Limited Interim Pesticides, Office of Pesticide Programs (OPP) 
Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 
Pennsylvania Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket Facility's normal hours of operation (8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays). 
Special arrangements should be made for deliveries of boxed 
information. The Docket Facility telephone number is (703) 305-5805.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2011-0360. EPA's policy is that all comments received will be included 
in the docket without change and may be made available on-line at 
https://www.regulations.gov, including any personal information 
provided, unless the comment includes information claimed to be 
Confidential Business Information (CBI) or other information whose 
disclosure is restricted by statute. Do not submit information that you 
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The regulations.gov Web site is an ``anonymous access'' system, 
which means EPA will not know your identity or contact information 
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through regulations.gov, 
your e-mail address will be automatically captured and included as part 
of the comment that is placed in the docket and made available on the 
Internet. If you submit an electronic comment, EPA recommends that you 
include your name and other contact information in the body of your 
comment and with any disk or CD-ROM you submit. If EPA cannot read your 
comment due to technical difficulties and cannot contact you for 
clarification, EPA may not be able to consider your comment. Electronic 
files should avoid the use of special characters, any form of 
encryption, and be free of any defects or viruses.
    Docket: All documents in the docket are listed in the docket index 
available at https://www.regulations.gov. Although listed in the index, 
some information is not publicly available, e.g., CBI or other 
information whose disclosure is restricted by statute. Certain other 
material, such as copyrighted material, is not placed on the Internet 
and will be publicly available only in hard copy form. Publicly 
available docket materials are available either in the electronic 
docket at https://www.regulations.gov, or, if only available in hard 
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac 
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The hours of 
operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday 
through Friday, excluding legal holidays. The Docket Facility telephone 
number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: Carmen Rodia, Registration Division 
(7504P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Avenue, NW., Washington, DC 20460-0001; telephone 
number: (703) 306-0327; fax number: (703) 308-0029; e-mail address: 
rodia.carmen@epa.gov.

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. If you have any 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

B. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through 
regulations.gov or e-mail. Clearly mark the part or all of the 
information that you claim to be CBI. For CBI information in a disk or 
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as 
CBI and then identify electronically within the disk or CD-ROM the 
specific information that is claimed as CBI. In addition to one 
complete version of the comment that includes information claimed as 
CBI, a copy of the comment that does not contain the information 
claimed as CBI must be submitted for inclusion in the public docket. 
Information so marked will not be disclosed except in accordance with 
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When submitting comments, 
remember to:
    i. Identify the document by docket ID number and other identifying 
information (subject heading, Federal Register date and page number).
    ii. Follow directions. The Agency may ask you to respond to 
specific questions or organize comments by referencing a Code of 
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and 
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information 
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you 
arrived at your estimate in sufficient detail to allow for it to be 
reproduced.
    vi. Provide specific examples to illustrate your concerns and 
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of 
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period 
deadline identified.

[[Page 33186]]

II. Background

    Following the enactment of the Food Quality Protection Act of 1996 
(FQPA), EPA reviewed and assessed under the new FQPA aggregate risk 
standard, the existing tolerances of 31 organophosphates (OPs), 
including tetrachlorvinphos (TCVP). In late December 2002, EPA reported 
the results of its assessment of TCVP tolerances in its Tolerance 
Reassessment Eligibility Decision (TRED) document, (67 FR 77491, 
December 18, 2002) (FRL-7279-2).
    The TCVP TRED concluded that the TCVP livestock residue studies 
were not adequate, and recommended that the Agency require the 
registrant to conduct and submit new magnitude of residue (MOR) studies 
to support permanent TCVP tolerances. The TCVP TRED also recommended 
the Agency revoke 4 existing tolerances in commodities supporting TCVP 
uses that were no longer registered. Finally, the TRED recommended that 
the Agency use existing TCVP metabolism studies to modify 5 existing 
livestock tolerances (fat of cattle, hogs and poultry as well as eggs 
and milk fat) and establish 11 tolerances for additional tissues of 
cattle, hogs and poultry (such as meat, meat byproducts and kidney and 
liver). Specifically, the TRED recommended that EPA establish 16 TCVP 
tolerances as ``time-limited for a period of 18 months * * * to permit 
sufficient time for the registrant to submit the required MOR 
studies.'' TCVP TRED at 41. On February 6, 2004, EPA issued a Generic 
Data Call-In Notice requiring the registrant to conduct and submit new 
livestock MOR studies for meat, milk, poultry, and eggs.
    On February 6, 2008, pursuant to section 408(e) of the FFDCA, EPA 
proposed to revoke, modify and establish tolerances for 10 pesticides, 
including TCVP (73 FR 6867) (FRL-8345-2). EPA explained that the 
proposed tolerance actions were a ``follow-up to the Agency 
reregistration program under Federal Insecticide, Fungicide, and 
Rodenticide Act (FIFRA), and tolerance reassessment program under FFDCA 
section 408(q).'' Id. As such, EPA proposed to implement the tolerance 
recommendations made in the TCVP TRED by:
    (1) Revising the tolerance expression in 40 CFR 180.252 to regulate 
the residues of TCVP and its metabolites;
    (2) Revise and establish 16 time-limited TCVP livestock tolerances 
to reflect levels of TCVP and its metabolites in various metabolism 
studies; and
    (3) Revoke tolerances for residues of TCVP for goat fat and horse 
fat. Specifically, EPA proposed to establish the 16 TCVP tolerances for 
``18 months to permit time for the submission of additional MOR data to 
support permanent tolerances.'' (73 FR 6867, February 6, 2008). Because 
the Agency was taking action to establish tolerances in/on beef cattle, 
hog and poultry commodities, EPA determined that the exception that 
permitted the use of TCVP as an additive to beef cattle, dairy cattle, 
horse and swine feed at certain rates was no longer necessary. On 
September 17, 2008, EPA finalized the rule as proposed, establishing, 
among other things, 16 time-limited tolerances for TCVP with an 
expiration date of March 17, 2010 (73 FR 53732) (FRL-8375-2). For both 
the proposal and the final rule, EPA determined that the ``increased 
tolerances and new tolerances to be established are safe; i.e., there 
is a reasonable certainty that no harm will result from aggregate 
exposure to the pesticide chemical residue.'' (73 FR 53732, September 
17, 2008).
    It was EPA's intention that upon submission of the required TCVP 
MOR studies, the time-limited tolerances would be extended to allow EPA 
sufficient time to review the data with the expectation that the data 
would support the establishment of permanent tolerances. Prior to March 
17, 2010, the registrant did in fact submit MOR data in cattle (MRID 
47193001), MOR data in poultry (MRID 47589301), and the livestock 
validation methodology (MRID 47369201). However, due to a mistake on 
the part of EPA, the data were not reviewed in a timely manner. 
Compounding this error, EPA also failed to extend the time-limited 
tolerances to allow for the Agency to review the data and make a 
determination with respect to converting the time-limited tolerances 
into permanent tolerances.
    Accordingly, in order to remedy the Agency's mistake and to be 
consistent with its original proposal and final rule establishing the 
TCVP time-limited tolerances, EPA is proposing to extend the expired 
time-limited tolerances for another 18 months to allow EPA to review 
the livestock MOR data submitted by the registrant as well as 
subsequent submissions, including storage stability data (MRID 
47589301) to support the previously submitted MOR data in poultry, 
storage stability data (MRID 48378101) to support the previously 
submitted MOR data in cattle, and a waiver request for MOR data in 
swine.
    In the TCVP TRED, EPA ``found that, apart from consideration of the 
potential cumulative risks from all of the OPs, each of the tolerances 
would meet the FFDCA safety standard. EPA has not considered the impact 
of these cumulative risks in the reassessment of these tolerances and 
has determined that these tolerances make, at most, only a negligible 
contribution to the overall risks from OPs. Therefore, these tolerances 
can be maintained regardless of the outcome of the OP cumulative 
assessment and any potential regulatory action taken as a result of 
that assessment. Accordingly, EPA ``believes it is appropriate to 
consider these tolerances reassessed for the purposes of section 408(q) 
of FQPA as of July 23, 2002.'' (67 FR 52985, August 14, 2002) (FRL-
7192-4).
    Among the factors EPA considered in making the decision to reassess 
these tolerances were extensive livestock feeding/metabolism studies as 
well as extensive monitoring data that was in agreement with the 
livestock feeding/metabolisms studies. In sum, there were very few 
detectable residues in the OP monitoring data for animal commodities. 
EPA relied upon extensive monitoring data from the U.S. Department of 
Agriculture's (USDA) Pesticide Data Program (PDP) and U.S. Food and 
Drug Administration's (FDA) Total Diet Study (TDS) covering residues of 
multiple OPs in meats and poultry. The residue monitoring data showed 
infrequent detections, and those residues were detected at low levels. 
Out of approximately 400 meat samples analyzed by the TDS for multiple 
OPs from 1991-1999, only 9 samples detected any OP residues (the 
residues ranged between 0.002 ppm and 0.009 ppm). Out of the 
approximately 500 poultry samples analyzed by PDP for multiple OPs from 
1997-2000, only 1 sample detected an OP residue (0.01 ppm) for a 
pesticide that currently has a tolerance. Id. For milk and eggs, 
extensive monitoring data were available from USDA's PDP and FDA's TDS. 
The residue monitoring data showed no detectable OP residues in milk 
(there was only 1 trace sample detected out of approximately 1,800 
samples analyzed by PDP for multiple OPs from 1996-1998). The residue 
monitoring for eggs also showed no detectable OP residues (only 1 trace 
sample was detected out of approximately 1,300 samples analyzed by TDS 
for multiple OPs from 1992-1998). Id.
    In July of 2006, EPA completed the OP cumulative risk assessment 
(CRA), using the best available monitoring data. The updated USDA PDP 
data indicated that OP residues would not be expected to occur in 
significant amounts in meat

[[Page 33187]]

or milk. The analysis in the OP CRA indicated that animal commodities 
do not significantly contribute to OP dietary exposure and total OP 
dietary risk. This characterization was supported by additional 
information, including the updated TDS data. On July 31, 2006, EPA 
finalized the TCVP reregistration eligibility determination by 
concluding that the pesticide tolerances covered by the IREDs and TREDs 
that were pending the result of the OP CRA--including TCVP tolerances, 
meet the safety standard under section 408(b)(2) of the FFDCA.
    In 2008, EPA confirmed that USDA PDP analyses of livestock 
commodities, including milk, poultry, pork, and beef, through 2005 
showed virtually no detectable residues of TCVP (except for 2 lone milk 
samples detected at levels just above the LOQ (less than one part per 
billion), detected out of approximately 5,200 samples analyzed by PDP 
for multiple OPs from 2001-2005. Furthermore, the USDA Food Safety and 
Inspection Service (FSIS) monitors meat for residues of 
tetrachlorvinphos, and there have been no detections of 
tetrachlorvinphos from 2000-2009.

III. Proposal

    EPA on its own initiative, under section 408(e) of the FFDCA, 21 
U.S.C. 346a(e), is proposing to extend the dates of expiration/
revocation for the time-limited interim tolerances for the combined 
residues of the insecticide tetrachlorvinphos (Z)-2-chloro-1-(2,4,5-
trichlorophenyl) vinyl dimethyl phosphate, including its metabolites, 
1-(2,4,5-trichlorophenyl)-ethanol (free and conjugated forms), 2,4,5-
trichloroacetophenone, and 1-(2,4,5-trichlorophenyl)-ethanediol, in or 
on cattle, fat (of which no more than 0.1 ppm is tetrachlorvinphos per 
se) at 0.2 parts per million (ppm); cattle, kidney (of which no more 
than 0.05 ppm is tetrachlorvinphos per se) at 1.0 ppm; cattle, liver 
(of which no more than 0.05 ppm is tetrachlorvinphos per se) at 0.5 
ppm; cattle, meat (of which no more than 2.0 ppm is tetrachlorvinphos 
per se) at 2.0 ppm; cattle, meat byproducts, except kidney and liver at 
1.0 ppm; egg (of which no more than 0.05 ppm is tetrachlorvinphos per 
se) at 0.2 ppm; hog, fat (of which no more than 0.1 ppm is 
tetrachlorvinphos per se) at 0.2 ppm; hog, kidney (of which no more 
than 0.05 ppm is tetrachlorvinphos per se) at 1.0 ppm; hog, liver (of 
which no more than 0.05 ppm is tetrachlorvinphos per se) at 0.5 ppm; 
hog, meat (of which no more than 2.0 ppm is tetrachlorvinphos per se) 
at 2.0 ppm; hog, meat byproducts, except kidney and liver at 1.0 ppm; 
milk, fat (reflecting negligible residues in whole milk and of which no 
more than 0.05 ppm is tetrachlorvinphos per se) at 0.05 ppm; poultry, 
fat (of which no more than 7.0 ppm is tetrachlorvinphos per se) at 7.0 
ppm; poultry, liver (of which no more than 0.05 ppm is 
tetrachlorvinphos per se) at 2.0 ppm; poultry, meat (of which no more 
than 3.0 ppm is tetrachlorvinphos per se) at 3.0 ppm; and poultry, meat 
byproducts, except liver at 2.0 ppm, for a period of 18 months 
following the date of publication of the final rule in the Federal 
Register, in order to provide the Agency with additional time to 
complete the reviews of the submitted livestock MOR data, storage 
stability data, and the waiver request for the swine MOR data.

IV. Statutory and Executive Order Reviews

    This proposed rule establishes a tolerance under section 408(e) of 
FFDCA. 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 proposed rule has been exempted from review under Executive Order 
12866 due to its lack of significance, this proposed rule is not 
subject to Executive Order 13211, entitled Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use (66 FR 28355, May 22, 2001). This proposed rule does not contain 
any information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose any enforceable 
duty or contain any unfunded mandate as described under Title II of the 
Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 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 are being established under section 408(e) of the FFDCA, 
such as the tolerance in this proposed 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. The Agency 
hereby certifies that this proposed action will not have significant 
negative economic impact on a substantial number of small entities. In 
addition, the Agency has determined that this action will not have a 
substantial direct effect on States, on the relationship between the 
national government and the States, or on the distribution of power and 
responsibilities among the various levels of government, as specified 
in Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 
1999). Executive Order 13132 requires EPA to develop an accountable 
process to ensure ``meaningful and timely input by State and local 
officials in the development of regulatory policies that have 
federalism implications.'' ``Policies that have federalism 
implications'' is defined in the Executive order to include regulations 
that have ``substantial direct effects on the States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government.'' This proposed rule directly regulates growers, food 
processors, food handlers, and food retailers, not States. This action 
does not alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of section 408(n)(4) of the FFDCA. For these same reasons, the Agency 
has determined that this proposed rule does not have any ``Tribal 
implications'' as described in Executive Order 13175, entitled 
Consultation and Coordination with Indian Tribal Governments (65 FR 
67249, November 9, 2000). Executive Order 3175 requires EPA to develop 
an accountable process to ensure ``meaningful and timely input by 
Tribal officials in the development of regulatory policies that have 
Tribal implications.'' ``Policies that have Tribal implications'' is 
defined in the Executive order to include regulations that have 
``substantial direct effects on one or more Indian Tribes, on the 
relationship between the Federal Government and the Indian Tribes, or 
on the distribution of power and responsibilities between the Federal 
Government and Indian Tribes.'' This proposed rule will not have 
substantial direct effects on Tribal governments, on the relationship 
between the Federal Government and Indian Tribes, or on the 
distribution of power and responsibilities between the Federal 
Government and Indian Tribes, as

[[Page 33188]]

specified in Executive Order 13175. Thus, Executive Order 13175 does 
not apply to this proposed rule.

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: May 26, 2011.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, it is proposed that 40 CFR chapter I be amended as 
follows:

PART 180--[AMENDED]

    1. The authority citation for part 180 continues to read as 
follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

    2. Section 180.252 is revised to read as follows:


Sec.  180.252  Tetrachlorvinphos; tolerances for residues.

    (a) General. Tolerances are established for the combined residues 
of the insecticide tetrachlorvinphos (Z)-2-chloro-1-(2,4,5-
trichlorophenyl) vinyl dimethyl phosphate, including its metabolites, 
1-(2,4,5-trichlorophenyl)-ethanol (free and conjugated forms), 2,4,5-
trichloroacetophenone, and 1-(2,4,5-trichlorophenyl)-ethanediol, in or 
on the following commodities:

------------------------------------------------------------------------
                                    Parts per     Expiration/revocation
            Commodity                million              date
------------------------------------------------------------------------
Cattle, fat (of which no more             0.2   [date 18 months from the
 than 0.1 ppm is                                 date of Final tolerance
 tetrachlorvinphos per se).                      publication].
Cattle, kidney (of which no more          1.0   [date 18 months from the
 than 0.05 ppm is                                date of Final tolerance
 tetrachlorvinphos per se).                      publication].
Cattle, liver (of which no more           0.5   [date 18 months from the
 than 0.05 ppm is                                date of Final tolerance
 tetrachlorvinphos per se).                      publication].
Cattle, meat (of which no more            2.0   [date 18 months from the
 than 2.0 ppm is                                 date of Final tolerance
 tetrachlorvinphos per se).                      publication].
Cattle, meat byproducts, except           1.0   [date 18 months from the
 kidney and liver.                               date of Final tolerance
                                                 publication].
Egg (of which no more than 0.05           0.2   [date 18 months from the
 ppm is tetrachlorvinphos per                    date of Final tolerance
 se).                                            publication].
Hog, fat (of which no more than           0.2   [date 18 months from the
 0.1 ppm is tetrachlorvinphos                    date of Final tolerance
 per se).                                        publication].
Hog, kidney (of which no more             1.0   [date 18 months from the
 than 0.05 ppm is                                date of Final tolerance
 tetrachlorvinphos per se).                      publication].
Hog, liver (of which no more              0.5   [date 18 months from the
 than 0.05 ppm is                                date of Final tolerance
 tetrachlorvinphos per se).                      publication].
Hog, meat (of which no more than          2.0   [date 18 months from the
 2.0 ppm is tetrachlorvinphos                    date of Final tolerance
 per se).                                        publication].
Hog, meat byproducts, except              1.0   [date 18 months from the
 kidney and liver.                               date of Final tolerance
                                                 publication].
Milk, fat (reflecting negligible          0.05  [date 18 months from the
 residues in whole milk and of                   date of Final tolerance
 which no more than 0.05 ppm is                  publication].
 tetrachlorvinphos per se).
Poultry, fat (of which no more            7.0   [date 18 months from the
 than 7.0 ppm is                                 date of Final tolerance
 tetrachlorvinphos per se).                      publication].
Poultry, liver (of which no more          2.0   [date 18 months from the
 than 0.05 ppm is                                date of Final tolerance
 tetrachlorvinphos per se).                      publication].
Poultry, meat (of which no more           3.0   [date 18 months from the
 than 3.0 ppm is                                 date of Final tolerance
 tetrachlorvinphos per se).                      publication].
Poultry, meat byproducts, except          2.0   [date 18 months from the
 liver.                                          date of Final tolerance
                                                 publication].
------------------------------------------------------------------------

     (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[FR Doc. 2011-14211 Filed 6-7-11; 8:45 am]
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