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Oxadixyl; Proposed Revocation of Tolerances
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[Federal Register: February 6, 2002 (Volume 67, Number 25)] [Proposed Rules] [Page 5548-5552] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr06fe02-28] ======================================================================= ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [OPP-301203; FRL-6817-4] RIN 2070-AC18 Oxadixyl; Proposed Revocation of Tolerances AGENCY: Environmental Protection Agency (EPA). ACTION: Proposed rule. ----------------------------------------------------------------------- SUMMARY: This document proposes to revoke specific tolerances for residues of the fungicide oxadixyl because this pesticide is no longer registered for those uses in the United States. EPA expects to determine whether any individuals or groups want to support these tolerances. The regulatory actions proposed in this document contribute toward the Agency's tolerance reassessment requirements of the Federal Food, Drug, and Cosmetic Act (FFDCA) section 408(q), as amended by the Food Quality Protection Act of 1996 (FQPA). By law, EPA is required by August 2002 to reassess 66% of the tolerances in existence on August 2, 1996, or about 6,400 tolerances. The regulatory actions proposed in this document pertain to the proposed revocation of 14 tolerances which would be counted among tolerance/exemption reassessments made toward the August 2002 review deadline. DATES: Comments, identified by docket control number OPP-301203, must be received on or before April 8, 2002. ADDRESSES: Comments may be submitted by mail, electronically, or in person. Please follow the detailed instructions for each method as provided in Unit I. of the SUPPLEMENTARY INFORMATION. To ensure proper receipt by EPA, it is imperative that you identify docket control number OPP-301203 in the subject line on the first page of your response. FOR FURTHER INFORMATION CONTACT: By mail: Joseph Nevola, Special Review and Reregistration Division (7508C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave, NW., Washington, DC 20460; telephone number: (703) 308-8037; e-mail address: nevola.joseph@epa.gov. [[Page 5549]] SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? You may be affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected categories and entities may include, but are not limited to: ------------------------------------------------------------------------ Examples of Categories NAICS Codes Potentially Affected Entities ------------------------------------------------------------------------ Industry 111 Crop production 112 Animal production 311 Food manufacturing 32532 Pesticide manufacturing ------------------------------------------------------------------------ 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 the table could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether or not this action might apply to certain entities. If you have questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT. B. How Can I Get Additional Information, Including Copies of this Document and Other Related Documents? 1. Electronically. You may obtain electronic copies of this document, and certain other related documents that might be available electronically, from the EPA Internet Home Page at http://www.epa.gov/. To access this document, on the Home Page select ``Laws and Regulations,'' ``Regulations and Proposed Rules, '' and then look up the entry for this document under the ``Federal Register--Environmental Documents.'' You can also go directly to the Federal Register listings at http://www.epa.gov/fedrgstr/. A frequently updated electronic version of 40 CFR part 180 is available at http://www.access.gpo.gov/ nara/cfr/cfrhtml_180/Title_40/40cfr180_00.html,a beta site currently under development. 2. In person. The Agency has established an official record for this action under docket control number OPP-301203. The official record consists of the documents specifically referenced in this action, and other information related to this action, including any information claimed as Confidential Business Information (CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period is available for inspection in the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is (703) 305-5805. C. How and to Whom Do I Submit Comments? You may submit comments through the mail, in person, or electronically. To ensure proper receipt by EPA, it is imperative that you identify docket control number OPP-301203 in the subject line on the first page of your response. 1. By mail. Submit your comments to: Public Information and Records Integrity Branch (PIRIB), Information Resources and Services Division (7502C), Office of Pesticide Programs (OPP), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. 2. In person or by courier. Deliver your comments to: Public Information and Records Integrity Branch (PIRIB), Information Resources and Services Division (7502C), Office of Pesticide Programs (OPP), Environmental Protection Agency, Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA. The PIRIB is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is (703) 305-5805. 3. Electronically. You may submit your comments electronically by e-mail to: opp-docket@epa.gov, or you can submit a computer disk as described in this unit. Do not submit any information electronically that you consider to be CBI. Electronic comments must be submitted as an ASCII file avoiding use of special characters and any form of encryption. Comments and data will also be accepted on standard disks in WordPerfect 6.1/8.0 or ASCII file format. All comments in electronic form must be identified by docket control number OPP-301203. Electronic comments may also be filed online at many Federal Depository Libraries. D. How Should I Handle CBI that I Want to Submit to the Agency? Do not submit any information electronically that you consider to be CBI. You may claim information that you submit to EPA in response to this document as CBI by marking any part or all of that information as CBI. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. In addition to one complete version of the comment that includes any 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 version of the official record. Information not marked confidential will be included in the public version of the official record without prior notice. If you have any questions about CBI or the procedures for claiming CBI, please consult the person listed under FOR FURTHER INFORMATION CONTACT. E. What Should I Consider as I Prepare My Comments for EPA? You may find the following suggestions helpful for preparing your comments: 1. Explain your views as clearly as possible. 2. Describe any assumptions that you used. 3. Provide copies of any technical information and/or data you used that support your views. 4. If you estimate potential burden or costs, explain how you arrived at the estimate that you provide. 5. Provide specific examples to illustrate your concerns. 6. Offer alternative ways to improve the proposed rule or collection activity. 7. Make sure to submit your comments by the deadline in this document. 8. To ensure proper receipt by EPA, be sure to identify the docket control number assigned to this action in the subject line on the first page of your response. You may also provide the name, date, and Federal Register citation. F. What Can I Do if I Wish the Agency to Maintain a Tolerance that the Agency Proposes to Revoke? This proposed rule provides a comment period of 60 days for any person to state an interest in retaining a tolerance proposed for revocation. If EPA receives a comment within the 60-day period to that effect, EPA will not proceed to revoke the tolerance immediately. However, EPA will take steps to ensure the submission of any [[Page 5550]] needed supporting data and will issue an order in the Federal Register under FFDCA section 408(f) if needed. The order would specify data needed and the time frames for its submission, and would require that within 90 days some person or persons notify EPA that they will submit the data. If the data are not submitted as required in the order, EPA will take appropriate action under FFDCA. EPA issues a final rule after considering comments that are submitted in response to this proposed rule. In addition to submitting comments in response to this proposal, you may also submit an objection at the time of the final rule. If you fail to file an objection to the final rule within the time period specified, you will have waived the right to raise any issues resolved in the final rule. After the specified time, issues resolved in the final rule cannot be raised again in any subsequent proceedings. II. Background A. What Action is the Agency Taking? On April 23, 2001, and on May 11, 2001, Gustafson LLC (end use product registrant) and Syngenta Crop Protection, Inc. (technical and end use product registrant), respectively, requested voluntary cancellation of all of their oxadixyl product registrations. On August 15, 2001, EPA published a notice in the Federal Register (66 FR 42854) (FRL-6796-4) under section 6(f)(1) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) announcing its receipt of these requests. Also, the registrants requested and EPA agreed to waive the 180-day public comment period contained in FIFRA section 6(f)(1)(C)(ii). Therefore, EPA provided a 30-day public comment period which ended on September 14, 2001. No public comments were received during the 30-day comment period. EPA approved the registrants' requests for voluntary cancellation of oxadixyl registrations. EPA also inadvertently erroneously included oxadixyl in a batch 6(f)(1) notice published on August 22, 2001 (66 FR 44131) (FRL-6795-5) that listed the comment period as 180 days. The 30-day comment period associated with the August 15, 2001 notice was the correct one. The cancellations were effective September 27, 2001, and announced in a cancellation order published in the Federal Register on November 1, 2001 (66 FR 55158) (FRL-6808-4). In a June 1, 2001 letter to EPA, Syngenta stated that the last known production of oxadixyl was prior to January 1, 1997. Syngenta is also not aware of any stocks of the products in the channels of trade. Likewise, in their June 1, 2001 letter, Gustafson noted that the last date of manufacture was January 6, 1993, and the last remaining product which they had on hand was disposed of on April 4, 2001. Although the manufacture of oxadixyl products ended years ago and the registrants know of no products in channels of trade, the cancellation order allowed a period of 1-year from September 27, 2001, to permit all sale and distribution of existing stocks. The Agency believes that existing stocks of oxadixyl will be exhausted by spring of 2003. It is EPA's general practice to propose revocation of those tolerances for residues of pesticide active ingredients on crops for which there are no active registered uses under FIFRA, unless any person in comments on the proposal indicates a need for the tolerance to cover residues in or on imported commodities or domestic commodities legally treated. Because the Agency approved the registrants' requests for voluntary cancellation, oxadixyl is not registered under FIFRA for use on those commodities. Therefore, EPA is proposing in 40 CFR 180.456 to revoke all tolerances for residues of oxadixyl and its desmethyl metabolite, with an expiration/revocation date of September 27, 2003. The Agency believes that this date allows sufficient time for any oxadixyl-treated food commodities to pass through the channels of trade. For FQPA reassessment purposes, EPA counts ``Grass, forage, fodder and hay, group'' as three tolerances (grass, forage; grass, fodder; and grass, hay) and expects in a final rule to count a total of 14 tolerances as reassessed. In the interim, before the tolerance expires and to conform to current Agency practice, EPA is proposing to revise tolerance commodity terminology names in 40 CFR 180.456 as follows: for ``Brassica (cole) leafy vegetables group'' to ``vegetable, Brassica, leafy, group;'' ``cereal grains group (except wheat)'' to ''grain, cereal, except wheat, group;'' ``cotton seed'' to ``cotton, undelinted seed;'' ``cucurbit vegetables group'' to ``vegetable, cucurbit, group;'' ``fruiting vegetables (except cucurbits) group'' to ``vegetable, fruiting, group;'' ``leafy vegetables (except Brassica vegetables) group'' to ``vegetable, leafy, except Brassica, group;'' ``nongrass animal feeds (forage, fodder, straw, and hay) group'' to ``animal feed, nongrass, group;'' ``peas'' to ``pea,'' ``root and tuber vegetables group'' to ``vegetable, root and tuber, group;'' ``soybeans'' to ``soybean, seed;'' and ``sunflower seed'' to ``sunflower, seed.'' B. What is the Agency's Authority for Taking this Action? A ``tolerance'' represents the maximum level for residues of pesticide chemicals legally allowed in or on raw agricultural commodities and processed foods. Section 408 of FFDCA, 21 U.S.C. 301 et seq., as amended by the FQPA of 1996, Public Law 104-170, authorizes the establishment of tolerances, exemptions from tolerance requirements, modifications in tolerances, and revocation of tolerances for residues of pesticide chemicals in or on raw agricultural commodities and processed foods (21 U.S.C. 346(a)). Without a tolerance or exemption, food containing pesticide residues is considered to be unsafe and therefore, ``adulterated'' under section 402(a) of the FFDCA. If food containing pesticide residues is considered to be ``adulterated,'' you may not distribute the product in interstate commerce (21 U.S.C. 331(a) and 342(a)). For a food-use pesticide to be sold and distributed, the pesticide must not only have appropriate tolerances under the FFDCA, but also must be registered under FIFRA (7 U.S.C. et seq.). Food-use pesticides not registered in the United States have tolerances for residues of pesticides in or on commodities imported into the United States. EPA's general practice is to propose revocation of tolerances for residues of pesticide active ingredients on crops for which FIFRA registrations no longer exist and on which the pesticide may therefore no longer be used in the United States. EPA has historically been concerned that retention of tolerances that are not necessary to cover residues in or on legally treated foods may encourage misuse of pesticides within the United States. Nonetheless, EPA will establish and maintain tolerances even when corresponding domestic uses are canceled if the tolerances, which EPA refers to as ``import tolerances,'' are necessary to allow importation into the United States of food containing such pesticide residues. However, where there are no imported commodities that require these import tolerances, the Agency believes it is appropriate to revoke tolerances for unregistered pesticides in order to prevent potential misuse. Furthermore, as a general matter, the Agency believes that retention of import tolerances not needed to cover any imported food may result in unnecessary restriction on trade of pesticides and foods. Under section 408 of the FFDCA, a tolerance may only be established or maintained if EPA determines that the tolerance is safe [[Page 5551]] based on a number of factors, including an assessment of the aggregate exposure to the pesticide and an assessment of the cumulative effects of such pesticide and other substances that have a common mechanism of toxicity. In doing so, EPA must consider potential contributions to such exposure from all tolerances. If the cumulative risk is such that the tolerances in aggregate are not safe, then every one of these tolerances is potentially vulnerable to revocation. Furthermore, if unneeded tolerances are included in the aggregate and cumulative risk assessments, the estimated exposure to the pesticide would be inflated. Consequently, it may be more difficult for others to obtain needed tolerances or to register needed new uses. To avoid potential trade restrictions, the Agency is proposing to revoke tolerances for residues on crops uses for which FIFRA registrations no longer exist, unless someone expresses a need for such tolerances. Through this proposed rule, the Agency is inviting individuals who need these import tolerances to identify themselves and the tolerances that are needed to cover imported commodities. Parties interested in retention of the tolerances should be aware that additional data may be needed to support retention. These parties should be aware that, under FFDCA section 408(f), if the Agency determines that additional information is reasonably required to support the continuation of a tolerance, EPA may require that parties interested in maintaining the tolerances provide the necessary information. If the requisite information is not submitted, EPA may issue an order revoking the tolerance at issue. C. When Do These Actions Become Effective? EPA is proposing that the tolerances for oxadixyl be revoked as of September 27, 2003. EPA is proposing this revocation/expiration date because EPA believes that by this date all existing stocks of pesticide products labeled for the uses associated with the tolerances proposed for revocation will have been exhausted and that there is ample time for any treated food commodities to clear trade channels. Therefore, EPA believes the revocation/expiration date proposed in this document is reasonable. However, if EPA is presented with information that existing stocks of oxadixyl would still be available for use after the expiration date and that information is verified, EPA will consider extending the expiration date of the tolerance. If you have comments regarding existing stocks and whether the effective date accounts for these stocks, please submit comments as described under Unit I.E. Any commodities listed in this proposal treated with the pesticides subject to this proposal, and in the channels of trade following the tolerance revocations, shall be subject to FFDCA section 408(1)(5), as established by FQPA. Under this section, any residues of these pesticides in or on such food shall not render the food adulterated so long as it is shown to the satisfaction of FDA that, (1) the residue is present as the result of an application or use of the pesticide at a time and in a manner that was lawful under FIFRA, and (2) the residue does not exceed the level that was authorized at the time of the application or use to be present on the food under a tolerance or exemption from tolerance. Evidence to show that food was lawfully treated may include records that verify the dates that the pesticide was applied to such food. D. What Is the Contribution to Tolerance Reassessment? By law, EPA is required to reassess 66% or about 6,400 of the tolerances in existence on August 2, 1996, by August 2002. EPA is also required to assess the remaining tolerances by August 2006. As of January 22, 2002, EPA has reassessed over 3,830 tolerances. This document proposes to revoke 14 tolerances which would be counted as reassessments in a final rule toward the August 2002 review deadline of FFDCA section 408(q), as amended by FQPA in 1996. III. Are The Proposed Actions Consistent with International Obligations? The tolerance revocations in this proposal are not discriminatory and are designed to ensure that both domestically-produced and imported foods meet the food safety standards established by FFDCA. The same food safety standards apply to domestically-produced and imported foods. EPA is working to ensure that the U.S. tolerance reassessment program under FQPA does not disrupt international trade. EPA considers Codex Maximum Residue Limits (MRLs) in setting U.S. tolerances and in reassessing them. MRLs are established by the Codex Committee on Pesticide Residues, a committee within the Codex Alimentarius Commission, an international organization formed to promote the coordination of international food standards. It is EPA's policy to harmonize U.S. tolerances with Codex MRLs to the extent possible, provided that the MRLs achieve the level of protection required under FFDCA. EPA's effort to harmonize with Codex MRLs is summarized in the tolerance reassessment section of individual Reregistration Eligibility Decision documents. EPA has developed guidance concerning submissions for import tolerance support June 1, 2000 (65 FR 35069) (FRL-6559-3). This guidance will be made available to interested persons. Electronic copies are available on the internet at http://www.epa.gov/. On the Home Page select ``Laws and Regulations,'' then select ``Regulations and Proposed Rules'' and then look up the entry for this document under ``Federal Register--Environmental Documents.'' You can also go directly to the ``Federal Register'' listings at http://www.epa.gov/fedrgstr/. IV. Regulatory Assessment Requirements In this proposed rule, EPA is proposing to revoke specific tolerances established under FFDCA section 408. The Office of Management and Budget (OMB) has exempted this type of action (i.e., a tolerance revocation for which extraordinary circumstances do not exist) 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, 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) (Public Law 104-4). Nor does it require any special considerations as required by 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 other 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 [[Page 5552]] 12(d) (15 U.S.C. 272 note). Pursuant to the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), the Agency previously assessed whether revocations of tolerances might significantly impact a substantial number of small entities and concluded that, as a general matter, these actions do not impose a significant economic impact on a substantial number of small entities. This analysis was published on December 17, 1997 (62 FR 66020) (FRL-5753-1), and was provided to the Chief Counsel for Advocacy of the Small Business Administration. Taking into account this analysis, and available information concerning the pesticides listed in this proposed rule, I certify that this action will not have a significant economic impact on a substantial number of small entities. Specifically, as per the 1997 notice, EPA has reviewed its available data on imports and foreign pesticide usage and concludes that there is a reasonable international supply of food not treated with canceled pesticides. Furthermore, for the pesticide named in this proposed rule, the Agency knows of no extraordinary circumstances that exist as to the present proposed revocations that would change EPA's previous analysis. Any comments about the Agency's determination should be submitted to EPA along with comments on the proposal, and will be addressed prior to issuing a final rule. 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 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure ``meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.'' ``Policies that have tribal implications'' is defined in the Executive Order to include regulations that have ``substantial direct effects on one or more Indian tribes, on the relationship between the Federal government and the Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes.'' This 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: January 18, 2002. Marcia E. Mulkey, Director, Office of Pesticide Programs. Therefore, it is proposed that 40 CFR part 180 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), 346(a) and 371. 2. Section 180.456 is revised to read as follows: Sec. 180.456 Oxadixyl; tolerances for residues. (a) General. Tolerances are established for the combined residues of the fungicide oxadixyl [2-methoxy-N-(2-oxo-1,3-oxazolidin-3-yl)- acet-2',6'-xylidide] and its desmethyl (M-3) metabolite (2-hydroxy-N- (2-oxo-1,3-oxazolidin-3-yl)-acet-2',6'-xylidide), calculated as oxadixyl in or on the following raw agricultural commodities: ------------------------------------------------------------------------ Expiration/ Commodity Parts per Revocation million Date ------------------------------------------------------------------------ Animal feed, nongrass, group.................. 0.1 9/27/03 Cotton, undelinted seed....................... 0.1 9/27/03 Grain, cereal, except wheat, group............ 0.1 9/27/03 Grass, forage, fodder and hay, group.......... 0.1 9/27/03 Pea........................................... 0.1 9/27/03 Soybean, seed................................. 0.1 9/27/03 Sunflower, seed............................... 0.1 9/27/03 Vegetable, Brassica, leafy, group............. 0.1 9/27/03 Vegetable, cucurbit, group.................... 0.1 9/27/03 Vegetable, fruiting, group.................... 0.1 9/27/03 Vegetable, leafy, except Brassica, group...... 0.1 9/27/03 Vegetable, root and tuber, group.............. 0.1 9/27/03 ------------------------------------------------------------------------ (b) Section 18 emergency exemptions. [Reserved] (c) Tolerances with regional registrations. [Reserved] (d) Indirect or inadvertent residues. [Reserved] [FR Doc. 02-2512 Filed 2-5-02; 8:45 am] BILLING CODE 6560-50-S