Methyl Bromide; Proposed Pesticide Tolerance, 20752-20756 [2012-8390]

Download as PDF 20752 Federal Register / Vol. 77, No. 67 / Friday, April 6, 2012 / Proposed Rules Indian Tribal Governments This proposed rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it would not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. Energy Effects We have analyzed this proposed rule under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. We have determined that it is not a ‘‘significant energy action’’ under that order because it is not a ‘‘significant regulatory action’’ under Executive Order 12866 and is not likely to have a significant adverse effect on the supply, distribution, or use of energy. The Administrator of the Office of Information and Regulatory Affairs has not designated it as a significant energy action. Therefore, it does not require a Statement of Energy Effects under Executive Order 13211. erowe on DSK2VPTVN1PROD with PROPOSALS-1 Technical Standards The National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note) directs agencies to use voluntary consensus standards in their regulatory activities unless the agency provides Congress, through the Office of Management and Budget, with an explanation of why using these standards would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (e.g., specifications of materials, performance, design, or operation; test methods; sampling procedures; and related management systems practices) that are developed or adopted by voluntary consensus standards bodies. This proposed rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards. Environment We have analyzed this proposed rule under Department of Homeland Security Management Directive 023–01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA)(42 U.S.C. 4321–4370f), and have made a preliminary determination that this action is one of a category of actions which do not individually or cumulatively have a significant effect on VerDate Mar<15>2010 14:51 Apr 05, 2012 Jkt 226001 the human environment. This proposed rule involves implementation of regulations within 33 CFR Part 100 applicable to organized marine events on the navigable waters of the United States that could negatively impact the safety of waterway users and shore side activities in the event area. The category of water activities includes but is not limited to sail boat regattas, boat parades, power boat racing, swimming events, crew racing, canoe and sail board racing. We seek any comments or information that may lead to the discovery of a significant environmental impact from this proposed rule. List of Subjects in 33 CFR Part 100 Marine safety, Navigation (water), Reporting and recordkeeping requirements, Waterways. For the reasons discussed in the preamble, the Coast Guard proposes to amend 33 CFR part 100 as follows: PART 100—SAFETY OF LIFE ON NAVIGABLE WATERS 1. The authority citation for part 100 continues to read as follows: Authority: 33 U.S.C. 1233. 2. Add a temporary section, § 100.35– T05–0156 to read as follows: § 100.35–T05–0156 Special Local Regulations for Marine Events; Potomac River, National Harbor Access Channel, MD. (a) Regulated area. The following locations are regulated areas: All waters of the Potomac River, National Harbor Access Channel, within an area from the shoreline and then west to a line connecting the following positions: from position latitude 38°47′28″ N, longitude 077°01′20″ W; thence southerly to position latitude 38°46′49″ N, longitude 077°01′28″ W. All coordinates reference Datum NAD 1983. (b) Definitions: (1) Coast Guard Patrol Commander means a commissioned, warrant, or petty officer of the U.S. Coast Guard who has been designated by the Commander, Coast Guard Sector Baltimore. (2) Official Patrol means any vessel assigned or approved by Commander, Coast Guard Sector Baltimore with a commissioned, warrant, or petty officer on board and displaying a Coast Guard ensign. (c) Special local regulations: (1) Except for persons or vessels authorized by the Coast Guard Patrol Commander, no person or vessel may enter or remain in the regulated area. (2) The operator of any vessel in the regulated area must: (i) Stop the vessel immediately when directed to do so by PO 00000 Frm 00010 Fmt 4702 Sfmt 4702 the Coast Guard Patrol Commander or any Official Patrol. (ii) Proceed as directed by the Coast Guard Patrol Commander or any Official Patrol. (d) Enforcement period: This section will be enforced from 5 a.m. until 11 a.m. on August 5, 2012. Dated: March 22, 2012. Mark P. O’Malley, Captain, U.S. Coast Guard, Captain of the Port Baltimore. [FR Doc. 2012–8297 Filed 4–5–12; 8:45 am] BILLING CODE 9110–04–P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA–HQ–OPP–2012–0245; FRL–9345–1] RIN 2070–ZA16 Methyl Bromide; Proposed Pesticide Tolerance Environmental Protection Agency (EPA). ACTION: Proposed rule. AGENCY: This document proposes to establish a tolerance for residues of methyl bromide in or on cotton, undelinted seed under the Federal Food, Drug, and Cosmetic Act (FFDCA) because there is a need for imported undelinted cottonseed for use as feed for dairy cattle in the United States. This imported cottonseed has become necessary because cottonseed is a critical part of the dairy cattle diet and the 2011 U.S. cotton crop was significantly below average due to severe drought conditions in Texas. DATES: Comments must be received on or before June 5, 2012. ADDRESSES: Submit your comments, identified by docket identification (ID) number EPA–HQ–OPP–2012–0245, by one of the following methods: • Federal eRulemaking Portal: https:// www.regulations.gov. Follow the online instructions for submitting comments. • Mail: Office of Pesticide Programs (OPP) Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460–0001. • Delivery: OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S–4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only accepted during the Docket Facility’s normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). SUMMARY: E:\FR\FM\06APP1.SGM 06APP1 erowe on DSK2VPTVN1PROD with PROPOSALS-1 Federal Register / Vol. 77, No. 67 / Friday, April 6, 2012 / Proposed Rules 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–2012– 0245. EPA’s policy is that all comments received will be included in the docket without change and may be made available online 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 email comment directly to EPA without going through regulations.gov, your email 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: Kimberly Nesci, Registration Division VerDate Mar<15>2010 14:51 Apr 05, 2012 Jkt 226001 (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460–0001; telephone number: (703) 308–8059; email address: nesci.kimberly@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 email. 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). PO 00000 Frm 00011 Fmt 4702 Sfmt 4702 20753 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. Comments not timely-filed will not be considered in EPA’s decision on this proposal or in any subsequent proceedings in this rulemaking. II. This Proposal EPA on its own initiative, under FFDCA section 408(e), 21 U.S.C. 346a(e), is proposing to establish a tolerance for residues of the fumigant methyl bromide, in or on cotton, undelinted seed at 150 parts per million (ppm) in newly proposed 40 CFR 180.124. The Animal and Plant Health Inspection Service, an agency of the United States Department of Agriculture (USDA–APHIS), supports EPA’s proposal to establish this tolerance. Undelinted cottonseed, also known as fuzzy cottonseed, needs to be imported into the United States for use as feed for dairy cattle in the United States. Cottonseed is a critical part of the dairy cattle diet because it is high in protein, energy, and fiber. In 2011, the size of the U.S. cotton crop was significantly below average due to severe drought conditions in Texas, the leading cotton producing state in the United States. As a result, U.S. cottonseed has been in short supply since the November 2011 harvest causing hardship for U.S. dairy cattle farmers. The USDA–APHIS has, in the past, pursuant to its authorities from the Plant Protection Act (PPA, as amended, 7 U.S.C. 7701 et seq.), required imported cottonseed to be fumigated as a condition of entry into the United States. APHIS evaluated the use of methyl bromide for such fumigation and has determined through efficacy studies that methyl bromide does effectively mitigate potential pests of concern such as Fusarium oxysporum f. sp. E:\FR\FM\06APP1.SGM 06APP1 20754 Federal Register / Vol. 77, No. 67 / Friday, April 6, 2012 / Proposed Rules erowe on DSK2VPTVN1PROD with PROPOSALS-1 vasinfectum strains Boggabilla (VCG01112) and Cecil Plains (VCG01111) that imported undelinted cottonseed could harbor. These Fusarium strains are not known to occur in the United States. Fusarium oxysporum f. sp. vasinfectum causes Fusarium wilt of cotton and, if introduced, these foreign strains could cause significant losses to U.S. cotton crops. The PPA authorizes the Secretary of Agriculture (who has delegated this authority to APHIS) to facilitate imports of agricultural commodities that pose a risk of harboring plant pests, among other pests, in ways that will reduce the risk of dissemination of plant pests that could constitute a threat to crops and other plants or plant products and burden interstate or foreign commerce. The Secretary may prohibit or restrict the importation, entry, exportation, or movement in interstate commerce of any plant, plant product, noxious weed, or article if the Secretary determines that the prohibition or restriction is necessary to prevent the introduction of a plant pest into the United States or the dissemination of a plant pest within the United States. As a feed commodity, imported cottonseed that has been fumigated with methyl bromide requires a tolerance. Without a tolerance or exemption, food or feed containing pesticide residues is considered to be unsafe and therefore ‘‘adulterated’’ under section 402(a) of FFDCA, 21 U.S.C. 342(a). Such food or feed may not be distributed in interstate commerce (21 U.S.C. 331(a)). III. Determination of Safety and Exposure 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.’’ 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.* * *’’ Given the characteristics of methyl bromide, EPA concludes that the use of methyl bromide on cottonseed will result in detectable residues on the VerDate Mar<15>2010 14:51 Apr 05, 2012 Jkt 226001 cottonseed itself. Although the Agency does not have controlled fumigation trial data for this cottonseed use, EPA has received such data for numerous other related commodities and use patterns. The data that would be most representative of potential residues in/ on cottonseed are from methyl bromide trials with tree nuts because commodities with higher fat content, such as nuts and oils, tend to have higher residues. EPA is proposing a tolerance level of 150 parts per million (ppm), which is based on the highest residue found in tree nuts 24 hours after fumigation (138 ppm). Dissipation studies indicated that residues dissipate relatively quickly, which is consistent with the high vapor pressure of methyl bromide. Despite the tendency for rapid dissipation shown in numerous studies, the Agency believes there is still the potential for quantifiable residues in the imported cottonseed. However, residues are likely to be much less than the proposed tolerance level. EPA further concludes that the use of methyl bromide to fumigate imported cottonseed will not result in any human dietary exposure to methyl bromide residues. There are two potential human dietary exposure pathways from treated cottonseed: Cottonseed oil, an edible commodity produced from cottonseed, and livestock commodities from livestock fed treated cottonseed. Cottonseed itself is not consumed by humans, nor is it used to produce any other edible commodity because unrefined cottonseed and cottonseed meal contains a naturally occurring compound that is toxic to humans, gossypol. Cottonseed will be imported for the purpose of feeding dairy cattle. There is no reasonable expectation of finite residues of methyl bromide in livestock commodities from the use of methyl bromide to fumigate cottonseed. Methyl bromide residues in/on feed items are likely to significantly dissipate during storage due to the volatile nature of methyl bromide. Should there be methyl bromide residues remaining, the methyl bromide would likely undergo considerable changes in the digestive system of livestock. Methyl bromide is an alkylating agent and will probably undergo chemical reactions with the contents of the gut. These chemical reactions break down the compound into a bromide ion and a methyl group; thus, there will be no absorption of methyl bromide into the edible tissues of livestock. Further, methyl bromide has a very low octanol-water coefficient. Octanol-water co-efficient values measure the tendency for a chemical to partition into organic vs. PO 00000 Frm 00012 Fmt 4702 Sfmt 4702 aqueous environments, and is therefore commonly used to predict the likelihood for partitioning into fatty tissue where xenobiotics are more likely to persist. Chemicals that tend to bioaccumulate tend to have orders of magnitude higher octanol-water coefficient values than methyl bromide. And, although methyl bromide tends to be lipid soluble, the low octanol-water co-efficient value overwhelms this chemical characteristic. For these reasons, EPA does not believe there will be transfer of methyl bromide residues into the edible tissues of livestock. In its Reregistration Eligibility Decision document for methyl bromide, EPA also determined that no livestock commodity tolerances for methyl bromide are needed under 40 CFR 180.6(a)(3) because there is no reasonable expectation of finite methyl bromide residues in livestock commodities. Any inorganic bromide residues on livestock feeding items resulting from fumigation of cottonseed with methyl bromide are covered by existing inorganic bromide tolerances at 40 CFR 180.124. Even if the imported cottonseed were to be diverted to cottonseed oil production, there will be no human exposure to methyl bromide in the cottonseed oil. In producing oil from cottonseed, the oil is removed by mechanical high pressure screw, by solvent extraction, or a combination of the two processes. Under either procedure, the seed kernels are first rolled into flakes and heated in a cooker or conditioner to reduce moisture. Once the oil is extracted, it is refined by adding sodium hydroxide that removes impurities and soapstock from the oil. Most cottonseed oil is bleached to remove coloring agents and is then filtered. Finally, it is deodorized with steam under a partial vacuum to remove any off flavors. Bromide ion will be removed from the oil during the final clean-up steps because the bromide ion is water soluble and will be washed away during the sodium hydroxide refining procedure. See also Docket EPA–HQ–OPP–2006–0766 document number 0022 for further information on cottonseed processing. Because methyl bromide is a gas at room temperature, the heating procedures in cottonseed oil processing will dissipate all methyl bromide residues from the seed and oil. Cottonseed oil produced from cottonseed fumigated with methyl bromide would not contain residues of methyl bromide. Accordingly, EPA has determined that there would be no human dietary exposure to methyl bromide from the use of methyl bromide to fumigate cottonseed. If meat, milk, or cottonseed E:\FR\FM\06APP1.SGM 06APP1 Federal Register / Vol. 77, No. 67 / Friday, April 6, 2012 / Proposed Rules oil were imported rather than the cottonseeds themselves, no tolerance would be necessary. Because there will be no human dietary exposure to the methyl bromide in cottonseeds, EPA concludes that a methyl bromide tolerance in cottonseed, at the level proposed, will be safe for the general population, including infants and children. IV. Other Considerations A. Analytical Enforcement Methodology An adequate analytical method, the head-space procedure of King et al. is available for enforcement of methyl bromide tolerances. Samples are blended with water at high speed in airtight jars for 5 minutes. After 15 minutes, the partitioned gas phase is sampled and analyzed by gas chromatography with electron capture detection (GC/EC). See the February 22, 2002, Residue Chemistry Chapter for the methyl bromide RED available in Docket EPA–HQ–OPP–2005–0123. erowe on DSK2VPTVN1PROD with PROPOSALS-1 B. International Residue Limits In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint United Nations Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level. The Codex has not established a MRL for methyl bromide on cottonseed. V. Conclusion A tolerance is proposed for residues of methyl bromide in cottonseed at 150 ppm based on the finding that there would be no human dietary exposure to methyl bromide from treated cottonseed and no exposure to children. VI. Statutory and Executive Order Reviews EPA, at its own initiative, proposes to establish a tolerance under FFDCA section 408(d). The Office of Management and Budget (OMB) has exempted these types of actions from VerDate Mar<15>2010 14:51 Apr 05, 2012 Jkt 226001 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). Pursuant to the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), the Agency hereby certifies that this proposed action will not have significant negative economic impact on a substantial number of small entities. Establishing a pesticide tolerance or exemption from the requirement of a pesticide tolerance is, in effect, the removal of a regulatory restriction on pesticide residues in food and thus such an action will not have any negative economic impact on any entities, including 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 PO 00000 Frm 00013 Fmt 4702 Sfmt 4702 20755 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 FFDCA section 408(n)(4). 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 13175, requires EPA to develop an accountable process to ensure ‘‘meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.’’ ‘‘Policies that have tribal implications’’ is defined in the Executive order to include regulations that have ‘‘substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.’’ This proposed rule will not have substantial direct effects on tribal governments, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this proposed rule. List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: April 2, 2012. Steve Bradbury, Director, Office of Pesticide Programs. Therefore, it is proposed that 40 CFR chapter I be amended as follows: PART 180—[AMENDED] 1. The authority citation for part 180 continues to read as follows: Authority: 21 U.S.C. 321(q), 346a and 371. 2. Add § 180.124 to subpart C to read as follows: E:\FR\FM\06APP1.SGM 06APP1 20756 Federal Register / Vol. 77, No. 67 / Friday, April 6, 2012 / Proposed Rules § 180.124 Methyl bromide; tolerance for residues. (a) General. A tolerance is established for residues of the fumigant methyl bromide, including metabolites and degradates, in or on the commodity in the table below. Compliance with the tolerance level specified below is to be determined by measuring only methyl bromide. Commodity Parts per million Cotton, undelinted seed ........... 150 (b) Section 18 emergency exemptions. [Reserved] (c) Tolerances with regional registrations. [Reserved] (d) Indirect or inadvertent residues. [Reserved] [FR Doc. 2012–8390 Filed 4–5–12; 8:45 am] BILLING CODE 6560–50–P FEDERAL COMMUNICATIONS COMMISSION 47 CFR Part 73 [MM Docket No. 99–25; FCC 12–28] Implementation of the Local Community Radio Act of 2010; Revision of Service and Eligibility Rules for Low Power FM Stations Federal Communications Commission. ACTION: Proposed rule. AGENCY: In this document, the Commission seeks comment on how to amend its rules to implement certain provisions of the Local Community Radio Act of 2010 (‘‘LCRA’’) that are not already the subject of Commission action. It also proposes changes to its rules intended to promote the low power FM service’s localism and diversity goals, reduce the potential for licensing abuses, and clarify certain rules. SUMMARY: Comments must be filed on or before May 7, 2012, and reply comments must be filed on or before May 21, 2012. Written comments on the Paperwork Reduction Act proposed information collection requirements must be submitted by the public, Office of Management and Budget (OMB), and other interested parties on or before June 5, 2012. ADDRESSES: You may submit comments, identified by MM Docket No. 99–25, by any of the following methods: • Federal Communications Commission’s Web Site: https:// erowe on DSK2VPTVN1PROD with PROPOSALS-1 DATES: VerDate Mar<15>2010 14:51 Apr 05, 2012 Jkt 226001 fjallfoss.fcc.gov/ecfs2/. Follow the instructions for submitting comments. • Mail: Commission’s Secretary, Office of the Secretary, Federal Communications Commission, 445 12th St. SW., Room TW–A325, Washington, DC 20554. • People with Disabilities: Contact the FCC to request reasonable accommodations (accessible format documents, sign language interpreters, or phone: 202–418–0530 or TTY: 202– 418–0432). For detailed instructions for submitting comments and additional information on the rulemaking process, see the SUPPLEMENTARY INFORMATION section of this document. In addition to filing comments with the Secretary, a copy of any comments on the Paperwork Reduction Act information collection requirements contained herein should be submitted to the Federal Communications Commission via email to PRA@fcc.gov and to Nicholas A. Fraser, Office of Management and Budget, via email to Nicholas_A._Fraser@omb.eop.gov or via fax at 202–395–5167. FOR FURTHER INFORMATION CONTACT: Peter Doyle (202) 418–2789. For additional information concerning the Paperwork Reduction Act information collection requirements contained in this document, send an email to PRA@fcc.gov or contact Cathy Williams on (202) 418–2918. SUPPLEMENTARY INFORMATION: This is a synopsis of the Commission’s document in MM Docket No. 99–25, FCC No. 12– 28, adopted March 19, 2012. A synopsis of the order segments of this decision were published in a previous issue of the Federal Register. The full text of this document is available for inspection and copying during normal business hours in the FCC Reference Center (Room CY–A257), 445 12th Street SW., Washington, DC 20554. The full text may also be downloaded at: https://www.fcc.gov. Comment Period and Procedures Pursuant to §§ 1.415 and 1.419 of the Commission’s rules, 47 CFR 1.415, 1.419, interested parties may file comments and reply comments on or before the dates indicated on the first page of this document. Comments may be filed using the Commission’s Electronic Comment Filing System (ECFS). See Electronic Filing of Documents in Rulemaking Proceedings, 63 FR 24121 (1998). D Electronic Filers: Comments may be filed electronically using the Internet by accessing the ECFS: https:// fjallfoss.fcc.gov/ecfs2/. PO 00000 Frm 00014 Fmt 4702 Sfmt 4702 D Paper Filers: Parties who choose to file by paper must file an original and one copy of each filing. If more than one docket or rulemaking number appears in the caption of this proceeding, filers must submit two additional copies for each additional docket or rulemaking number. Filings can be sent by hand or messenger delivery, by commercial overnight courier, or by first-class or overnight U.S. Postal Service mail. All filings must be addressed to the Commission’s Secretary, Office of the Secretary, Federal Communications Commission. D All hand-delivered or messengerdelivered paper filings for the Commission’s Secretary must be delivered to FCC Headquarters at 445 12th St. SW., Room TW–A325, Washington, DC 20554. The filing hours are 8 a.m. to 7 p.m. All hand deliveries must be held together with rubber bands or fasteners. Any envelopes and boxes must be disposed of before entering the building. D Commercial overnight mail (other than U.S. Postal Service Express Mail and Priority Mail) must be sent to 9300 East Hampton Drive, Capitol Heights, MD 20743. D U.S. Postal Service first-class, Express, and Priority mail must be addressed to 445 12th Street SW., Washington, DC 20554. People with Disabilities: To request materials in accessible formats for people with disabilities (braille, large print, electronic files, audio format), send an email to fcc504@fcc.gov or call the Consumer & Governmental Affairs Bureau at 202–418–0530 (voice), 202– 418–0432 (tty). Paperwork Reducation Act of 1995 This document contains proposed information collection requirements. The Commission, as part of its continuing effort to reduce paperwork burdens, invites the general public and the Office of Management and Budget (OMB) to comment on the information collection requirements contained in this document, as required by the Paperwork Reduction Act of 1995, Public Law 104–13. Public and agency comments are due June 5, 2012. Comments should address: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; (b) the accuracy of the Commission’s burden estimates; (c) ways to enhance the quality, utility, and clarity of the information collected; (d) ways to minimize the burden of the collection of E:\FR\FM\06APP1.SGM 06APP1

Agencies

[Federal Register Volume 77, Number 67 (Friday, April 6, 2012)]
[Proposed Rules]
[Pages 20752-20756]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-8390]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2012-0245; FRL-9345-1]
RIN 2070-ZA16


Methyl Bromide; Proposed Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: This document proposes to establish a tolerance for residues 
of methyl bromide in or on cotton, undelinted seed under the Federal 
Food, Drug, and Cosmetic Act (FFDCA) because there is a need for 
imported undelinted cottonseed for use as feed for dairy cattle in the 
United States. This imported cottonseed has become necessary because 
cottonseed is a critical part of the dairy cattle diet and the 2011 
U.S. cotton crop was significantly below average due to severe drought 
conditions in Texas.

DATES: Comments must be received on or before June 5, 2012.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPP-2012-0245, by one of the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the online instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave. 
NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket Facility's normal hours of operation (8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).

[[Page 20753]]

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-
2012-0245. EPA's policy is that all comments received will be included 
in the docket without change and may be made available online 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 email comment 
directly to EPA without going through regulations.gov, your email 
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: Kimberly Nesci, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone 
number: (703) 308-8059; email address: nesci.kimberly@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 email. 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. Comments not timely-filed will not be considered 
in EPA's decision on this proposal or in any subsequent proceedings in 
this rulemaking.

II. This Proposal

    EPA on its own initiative, under FFDCA section 408(e), 21 U.S.C. 
346a(e), is proposing to establish a tolerance for residues of the 
fumigant methyl bromide, in or on cotton, undelinted seed at 150 parts 
per million (ppm) in newly proposed 40 CFR 180.124. The Animal and 
Plant Health Inspection Service, an agency of the United States 
Department of Agriculture (USDA-APHIS), supports EPA's proposal to 
establish this tolerance.
    Undelinted cottonseed, also known as fuzzy cottonseed, needs to be 
imported into the United States for use as feed for dairy cattle in the 
United States. Cottonseed is a critical part of the dairy cattle diet 
because it is high in protein, energy, and fiber. In 2011, the size of 
the U.S. cotton crop was significantly below average due to severe 
drought conditions in Texas, the leading cotton producing state in the 
United States. As a result, U.S. cottonseed has been in short supply 
since the November 2011 harvest causing hardship for U.S. dairy cattle 
farmers.
    The USDA-APHIS has, in the past, pursuant to its authorities from 
the Plant Protection Act (PPA, as amended, 7 U.S.C. 7701 et seq.), 
required imported cottonseed to be fumigated as a condition of entry 
into the United States. APHIS evaluated the use of methyl bromide for 
such fumigation and has determined through efficacy studies that methyl 
bromide does effectively mitigate potential pests of concern such as 
Fusarium oxysporum f. sp.

[[Page 20754]]

vasinfectum strains Boggabilla (VCG01112) and Cecil Plains (VCG01111) 
that imported undelinted cottonseed could harbor. These Fusarium 
strains are not known to occur in the United States. Fusarium oxysporum 
f. sp. vasinfectum causes Fusarium wilt of cotton and, if introduced, 
these foreign strains could cause significant losses to U.S. cotton 
crops. The PPA authorizes the Secretary of Agriculture (who has 
delegated this authority to APHIS) to facilitate imports of 
agricultural commodities that pose a risk of harboring plant pests, 
among other pests, in ways that will reduce the risk of dissemination 
of plant pests that could constitute a threat to crops and other plants 
or plant products and burden interstate or foreign commerce. The 
Secretary may prohibit or restrict the importation, entry, exportation, 
or movement in interstate commerce of any plant, plant product, noxious 
weed, or article if the Secretary determines that the prohibition or 
restriction is necessary to prevent the introduction of a plant pest 
into the United States or the dissemination of a plant pest within the 
United States.
    As a feed commodity, imported cottonseed that has been fumigated 
with methyl bromide requires a tolerance. Without a tolerance or 
exemption, food or feed containing pesticide residues is considered to 
be unsafe and therefore ``adulterated'' under section 402(a) of FFDCA, 
21 U.S.C. 342(a). Such food or feed may not be distributed in 
interstate commerce (21 U.S.C. 331(a)).

III. Determination of Safety and Exposure

    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.'' 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.* * *''
    Given the characteristics of methyl bromide, EPA concludes that the 
use of methyl bromide on cottonseed will result in detectable residues 
on the cottonseed itself. Although the Agency does not have controlled 
fumigation trial data for this cottonseed use, EPA has received such 
data for numerous other related commodities and use patterns. The data 
that would be most representative of potential residues in/on 
cottonseed are from methyl bromide trials with tree nuts because 
commodities with higher fat content, such as nuts and oils, tend to 
have higher residues. EPA is proposing a tolerance level of 150 parts 
per million (ppm), which is based on the highest residue found in tree 
nuts 24 hours after fumigation (138 ppm). Dissipation studies indicated 
that residues dissipate relatively quickly, which is consistent with 
the high vapor pressure of methyl bromide. Despite the tendency for 
rapid dissipation shown in numerous studies, the Agency believes there 
is still the potential for quantifiable residues in the imported 
cottonseed. However, residues are likely to be much less than the 
proposed tolerance level.
    EPA further concludes that the use of methyl bromide to fumigate 
imported cottonseed will not result in any human dietary exposure to 
methyl bromide residues. There are two potential human dietary exposure 
pathways from treated cottonseed: Cottonseed oil, an edible commodity 
produced from cottonseed, and livestock commodities from livestock fed 
treated cottonseed. Cottonseed itself is not consumed by humans, nor is 
it used to produce any other edible commodity because unrefined 
cottonseed and cottonseed meal contains a naturally occurring compound 
that is toxic to humans, gossypol.
    Cottonseed will be imported for the purpose of feeding dairy 
cattle. There is no reasonable expectation of finite residues of methyl 
bromide in livestock commodities from the use of methyl bromide to 
fumigate cottonseed. Methyl bromide residues in/on feed items are 
likely to significantly dissipate during storage due to the volatile 
nature of methyl bromide. Should there be methyl bromide residues 
remaining, the methyl bromide would likely undergo considerable changes 
in the digestive system of livestock. Methyl bromide is an alkylating 
agent and will probably undergo chemical reactions with the contents of 
the gut. These chemical reactions break down the compound into a 
bromide ion and a methyl group; thus, there will be no absorption of 
methyl bromide into the edible tissues of livestock. Further, methyl 
bromide has a very low octanol-water co-efficient. Octanol-water co-
efficient values measure the tendency for a chemical to partition into 
organic vs. aqueous environments, and is therefore commonly used to 
predict the likelihood for partitioning into fatty tissue where 
xenobiotics are more likely to persist. Chemicals that tend to 
bioaccumulate tend to have orders of magnitude higher octanol-water co-
efficient values than methyl bromide. And, although methyl bromide 
tends to be lipid soluble, the low octanol-water co-efficient value 
overwhelms this chemical characteristic. For these reasons, EPA does 
not believe there will be transfer of methyl bromide residues into the 
edible tissues of livestock. In its Reregistration Eligibility Decision 
document for methyl bromide, EPA also determined that no livestock 
commodity tolerances for methyl bromide are needed under 40 CFR 
180.6(a)(3) because there is no reasonable expectation of finite methyl 
bromide residues in livestock commodities. Any inorganic bromide 
residues on livestock feeding items resulting from fumigation of 
cottonseed with methyl bromide are covered by existing inorganic 
bromide tolerances at 40 CFR 180.124.
    Even if the imported cottonseed were to be diverted to cottonseed 
oil production, there will be no human exposure to methyl bromide in 
the cottonseed oil. In producing oil from cottonseed, the oil is 
removed by mechanical high pressure screw, by solvent extraction, or a 
combination of the two processes. Under either procedure, the seed 
kernels are first rolled into flakes and heated in a cooker or 
conditioner to reduce moisture. Once the oil is extracted, it is 
refined by adding sodium hydroxide that removes impurities and 
soapstock from the oil. Most cottonseed oil is bleached to remove 
coloring agents and is then filtered. Finally, it is deodorized with 
steam under a partial vacuum to remove any off flavors. Bromide ion 
will be removed from the oil during the final clean-up steps because 
the bromide ion is water soluble and will be washed away during the 
sodium hydroxide refining procedure. See also Docket EPA-HQ-OPP-2006-
0766 document number 0022 for further information on cottonseed 
processing. Because methyl bromide is a gas at room temperature, the 
heating procedures in cottonseed oil processing will dissipate all 
methyl bromide residues from the seed and oil. Cottonseed oil produced 
from cottonseed fumigated with methyl bromide would not contain 
residues of methyl bromide.
    Accordingly, EPA has determined that there would be no human 
dietary exposure to methyl bromide from the use of methyl bromide to 
fumigate cottonseed. If meat, milk, or cottonseed

[[Page 20755]]

oil were imported rather than the cottonseeds themselves, no tolerance 
would be necessary. Because there will be no human dietary exposure to 
the methyl bromide in cottonseeds, EPA concludes that a methyl bromide 
tolerance in cottonseed, at the level proposed, will be safe for the 
general population, including infants and children.

IV. Other Considerations

A. Analytical Enforcement Methodology

    An adequate analytical method, the head-space procedure of King et 
al. is available for enforcement of methyl bromide tolerances. Samples 
are blended with water at high speed in air-tight jars for 5 minutes. 
After 15 minutes, the partitioned gas phase is sampled and analyzed by 
gas chromatography with electron capture detection (GC/EC). See the 
February 22, 2002, Residue Chemistry Chapter for the methyl bromide RED 
available in Docket EPA-HQ-OPP-2005-0123.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint United Nations 
Food and Agriculture Organization/World Health Organization food 
standards program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level.
    The Codex has not established a MRL for methyl bromide on 
cottonseed.

V. Conclusion

    A tolerance is proposed for residues of methyl bromide in 
cottonseed at 150 ppm based on the finding that there would be no human 
dietary exposure to methyl bromide from treated cottonseed and no 
exposure to children.

VI. Statutory and Executive Order Reviews

    EPA, at its own initiative, proposes to establish a tolerance under 
FFDCA section 408(d). 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). Pursuant to the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.), the Agency hereby certifies that this proposed action will not 
have significant negative economic impact on a substantial number of 
small entities. Establishing a pesticide tolerance or exemption from 
the requirement of a pesticide tolerance is, in effect, the removal of 
a regulatory restriction on pesticide residues in food and thus such an 
action will not have any negative economic impact on any entities, 
including 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 FFDCA section 408(n)(4). 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 13175, requires EPA to 
develop an accountable process to ensure ``meaningful and timely input 
by tribal officials in the development of regulatory policies that have 
tribal implications.'' ``Policies that have tribal implications'' is 
defined in the Executive order to include regulations that have 
``substantial direct effects on one or more Indian tribes, on the 
relationship between the Federal Government and the Indian tribes, or 
on the distribution of power and responsibilities between the Federal 
Government and Indian tribes.'' This proposed rule will not have 
substantial direct effects on tribal governments, on the relationship 
between the Federal Government and Indian tribes, or on the 
distribution of power and responsibilities between the Federal 
Government and Indian tribes, as specified in Executive Order 13175. 
Thus, Executive Order 13175 does not apply to this proposed rule.

List of Subjects in 40 CFR Part 180

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

    Dated: April 2, 2012.
Steve Bradbury,
Director, Office of Pesticide Programs.

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

PART 180--[AMENDED]

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

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

    2. Add Sec.  180.124 to subpart C to read as follows:

[[Page 20756]]

Sec.  180.124  Methyl bromide; tolerance for residues.

    (a) General. A tolerance is established for residues of the 
fumigant methyl bromide, including metabolites and degradates, in or on 
the commodity in the table below. Compliance with the tolerance level 
specified below is to be determined by measuring only methyl bromide.

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Cotton, undelinted seed....................................          150
------------------------------------------------------------------------

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

[FR Doc. 2012-8390 Filed 4-5-12; 8:45 am]
BILLING CODE 6560-50-P
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