Pesticides; tolerances in food, animal feeds, and raw agricultural commodities: Vinclozolin,

[Federal Register: July 10, 2001 (Volume 66, Number 132)]

[Proposed Rules]

[Page 35921-35925]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr10jy01-20]

[[Page 35921]]

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-301121; FRL-6779-7]

RIN 2070-AB78

Vinclozolin; Notice of Proposed Pesticide Tolerance Revocations and Channels of Trade Provision Guidance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

SUMMARY: This document proposes to revoke the tolerances for the fungicide vinclozolin on strawberries, stonefruits, cucumbers, and bell peppers. Foods legally treated with vinclozolin may continue to be marketed under the provisions of the FFDCA. The regulatory actions proposed in this document are part of the Agency's reregistration program under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and the tolerance reassessment requirements of the Federal Food, Drug, and Cosmetic Act (FFDCA). By law, EPA is required to reassess 66% of the tolerances in existence on August 2, 1996, by August 2002, or about 6,400 tolerances. These tolerances were established under section 408 of the Federal Food, Drug, and Cosmetic Act (``FFDCA''), 21 U.S.C. 346a. EPA is proposing to revoke the strawberry and stonefruit tolerances because the Agency has canceled the pesticide registrations under Federal Insecticide, Fungicide, and Rodenticide Act (``FIFRA''), 7 U.S.C. 136 et seq., associated with them. In addition, the registrant for vinclozolin, BASF, is no longer supporting the tolerances on cucumbers and bell peppers, which were established for importation purposes only.

The Food and Drug Administration (FDA) in a related document published elsewhere in this issue of the Federal Register is announcing the availability of a proposed guidance document presenting FDA's policy on its planned enforcement approach for foods containing vinclozolin residues. This guidance will assist firms in understanding the types of showing under 408(1)(5) of the FFDCA (hereinafter referred to as the ``channels of trade provision'') that FDA may find satisfactory in accordance with its planned enforcement approach for such section. EPA and FDA are cooperating on this effort. FDA will be asking for comment on this proposed guidance and EPA also encourages you to comment on this guidance.

DATES: Comments, identified by the docket control number must be received on or before September 10, 2001.

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-301121 in the subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: Deanna Scher, Special Review and Registration Division (7508C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,Washington, DC 20460; telephone number: 703-308-7043; and e-mail address: Scher.Deanna@epa.gov.

SUPPLEMENTARY INFORMATION:

1. General Information

   1. Does this Action Apply to Me?

      You may be affected by this action if you sell, distribute, manufacture, or use pesticides for agricultural applications, process food, distribute or sell food, or implement governmental pesticide regulations. Potentially affected categories and entities may include, but are not limited to the following:

      Examples of Potentially Categories

      NAICS 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.

   2. 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'', 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-301121. 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.

   3. 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-301121 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

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         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-301121. Electronic comments may also be filedonline at many Federal Depository Libraries.

   4. 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.

   5. 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.

   6. What Can I do if I Wish the Agency to Maintain a Tolerance that the Agency Proposes to Revoke?

      As discussed in Unit II, below, EPA does not believe that these tolerances can be maintained under FFDCA. Persons believing otherwise should submit comments to this proposed rule and any evidence as to why the tolerances are consistent with the FFDCA safety standard. In addition, any person may petition EPA to establish new tolerances. Petitioners should consult EPA regulations at 40 CFR part 180 on the necessary data and information to support tolerance petitions.

2. Background

   1. What Action is the Agency Taking?

      After consultation with FDA, USDA and stakeholders, EPA is proposing to revoke the tolerances for the fungicide vinclozolin on strawberries, stonefruits, cucumbers, and bell peppers. EPA intends to finalize this action after consideration of comments. The tolerance revocation is proposed to be effective on the date of publication of the final rule.

   2. 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. 346a, 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. Without a tolerance or exemption, food containing pesticide residues is considered to be unsafe and therefore ``adulterated'' under section 402(a) of the FFDCA. (21 U.S.C. 342(a)). FFDCA section 301 prohibits, among other things, introduction or delivery for introduction into interstate commerce of any adulterated food. (21 U.S.C. 331(a)). For a pesticide to be sold and distributed, the pesticide must be registered under section 3, used in accordance with an experimental use permit under section 5, or exempted from section 3 requirements in accordance with section 18 of FIFRA (7 U.S.C. et seq.). Food-use pesticides not registered in the United States may have tolerances for residues of such pesticides in or on commodities imported into the United States, provided that EPA has determined that the tolerance is safe under section 408.

      Monitoring and enforcement of pesticide tolerances and exemptions are carried out by the U.S. Food and Drug Administration (FDA) and the U.S. Department of Agriculture (USDA). This includes monitoring for pesticide residues in or on commodities imported into the United States.

      Under FFDCA section 408(l)(2), if EPA cancels each FIFRA registration for the use of a pesticide on a food ``due in whole or in part to dietary risks to humans posed by residues of that pesticide chemical on food,'' EPA is required to revoke any tolerance or exemption in connection with the canceled use that allows residues of the pesticide on food. This provision imposes a mandatory duty on EPA. Once EPA cancels a FIFRA use due in part to dietary risks, EPA must revoke the associated tolerances and exemptions. Under section 408(l)(5), foods lawfully treated prior to the last legal use date may in most cases continue to be marketed.

   3. Why is this Action being Proposed?

      1. Strawberries and stonefruits. During a 1998 review of the vinclozolin toxicology data base, it was determined that an additional tenfold margin of safety, as specified in the Food Quality Protection Act, was required to protect the safety of infants and children. Based on EPA's assessment of the acute dietary risk posed by vinclozolin, the use of the additional tenfold margin of safety rendered aggregate risk to vinclozolin under existing use patterns unacceptable. BASF Corporation, the sole registrant for vinclozolin, requested amendment of its registrations to terminate the use of vinclozolin on strawberries and stonefruits in June 1998 in response to potential Agency action to revoke tolerances and cancel registrations due to unacceptable dietary risk. On July 30, 1998, EPA published a notice in the Federal Register (63 FR 40710-40712) (FRL-6020-9) announcing the cancellation of the FIFRA registered uses for the pesticide vinclozolin on strawberries and stonefruits. That notice informed the public of how it could comment on the request for cancellation. One comment was received in response to the proposal, submitted on behalf of the California Strawberry Commission. This

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         comment was fully addressed in a subsequent FR Notice (63 FR 59557- 59558) (FRL-6041-7) published on November 4, 1998 which announced the approval, with one minor change, of the proposed existing stocks provision for products containing vinclozolin. Under limitations on the use of existing stocks, the application of the pesticide vinclozolin on strawberries and stonefruit became unlawful after January 30, 2000.

         Although the use cancellations on strawberries and stonefruits were requested by the vinclozolin registrant, the cancellations closely followed, and in EPA's view, were precipitated by, EPA's determination that aggregate exposure to vinclozolin exceeded the safety standard under the FQPA. Thus, the cancellation action was ``due in whole or part to dietary risks to humans posed by residues of that pesticide chemical on food.''

      2. Cucumbers and bell peppers. Additional dietary and aggregate risk concerns were identified last year when vinclozolin was reevaluated for the purposes of reregistration. Acute dietary risk from vinclozolin in food was above the Agency's level of concern and potential exposure from surface and ground water sources exceeded the Agency's level of concern for cancer dietary risk from vinclozolin- derived 3,5-DCA (see vinclozolin RED, http://www.epa.gov/REDs/). On May 31, 2000, BASF submitted a risk mitigation proposal designed to address dietary and aggregate risk concerns identified during the reregistration process for vinclozolin. BASF requested a phase out of all domestic food uses of vinclozolin except for use on canola (65 FR 56894, September 20, 2000) (FRL-6744-2). The proposal also involved the cancellation of all import tolerances except for wine grapes; specifically, the import tolerances for cucumbers and bell peppers. Vinclozolin is not registered for use on bell peppers and cucumbers in the United States. BASF requested that EPA revoke the established import tolerances for bell peppers and cucumbers not before January 1, 2001. These mitigation measures allowed the Agency to determine that the use of vinclozolin, with the amendments proposed by the registrant, would meet the safety standard of the Food Quality Protection Act (FQPA).

   4. When do These Actions Become Effective?

      Under FFDCA section 408(l)(2), revocations required by that provision must take place no later than 180 days after the date such cancellation takes effect or the date on which the use of the canceled pesticide becomes unlawful under the terms of the cancellation, whichever is later. EPA approved BASF's label amendments deleting strawberries and stone fruits in September, 1998; however, use of vinclozolin on strawberries and stonefruits did not become unlawful until January 30, 2000, the last date for use of existing stocks. Since vinclozolin is not registered for use on bell peppers and cucumbers in the United States, imported cucumbers and bell peppers are the only foods that will be affected by this proposal. FFDCA 408(l)(2) does not apply to these commodities because there are no associated FIFRA uses. EPA intends to finalize this action as quickly as possible after consideration of comments. The tolerance revocation is proposed to be effective on the date of final publication.

   5. Will Food Treated Prior to the Last Lawful Date of Application Be Permitted to Clear the Channels of Trade?

      Any commodities listed in the regulatory text of this document that are treated with vinclozolin, and that are in the channels of trade following the tolerance revocations, shall be subject to FFDCA section 408(l)(5), as established by the FQPA. Under this section, any residue of vinclozolin in or on such commodities shall not render the commodities 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 a tolerance. The channels of trade provision allows for the orderly marketing of foods that may currently contain legal residues resulting from lawful applications of vinclozolin.

      Use of vinclozolin on strawberries and stonefruits became unlawful under FIFRA on January 30, 2000, the last date on which use of existing stocks was permitted. Because application of vinclozolin outside the United States after January 30, 2000 is essentially unregulated by FIFRA, EPA considers commodities with residues resulting from application outside the United States after that date to be outside the scope of the channels of trade provision in section 408(l)(5). Therefore, residues on both domestic and foreign commodities treated subsequent to January 30, 2000 would not be 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 thus, would not be covered or subject to the channels of trade provision.

      FDA is announcing, elsewhere in this issue of Federal Register, the availability of a proposed guidance document on how it plans to administer FFDCA section 408(l)(5) for both domestic and imported commodities. FDA will invite comment on this draft guidance before issuing any final guidance. EPA encourages all interested parties to commnet on FDA's draft guidance.

      Considering the perishable nature of cucumbers and bell peppers, FDA estimates that they will either be consumed as fresh produce or will be further processed within three months of the effective date of the tolerance revocations. FDA's guidance indicates its intent to exercise enforcement discretion following the effective date of the revocation of the associated tolerances in order to: (1) Allow fresh bell peppers and cucumbers which bear residues of vinclozolin and which were imported prior to the effective date of tolerance revocation, to reach the ultimate consumer or be sold for further processing and (2) permit bell peppers and cucumbers bearing residues of vinclozolin which were processed abroad no later than three months after the tolerance revocations, to be subsequently imported into the U.S., thus granting equal treatment to foreign and domestic processors. EPA believes that allowing bell peppers or cucumbers to remain in domestic commerce during this three month period, or permitting processed bell peppers or cucumbers processed abroad during that 3 month period to be imported into the U.S., will not significantly impact the dietary risk contribution to the general population or any population subgroup. Exposure to residues is expected to be very low due to the fact that the majority of cucumbers and bell peppers consumed in the U.S. are grown domestically and of the fraction which are imported into the United States, EPA estimates that 1% or less have been treated with vinclozolin.

   6. 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 October 15, 2000, EPA has reassessed over 3,550 tolerances. This document proposes to revoke 4 vinclozolin tolerances; however, the reassessments were previously counted in 1997 when all vinclozolin tolerances

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      were reassessed in order to make a decision on a new tolerance petition. Consequently, no further vinclozolin reassessments, including these 4 revocations, count towards the August, 2002 review deadline of FFDCA section 408(q).

3. 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 the 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. The U.S. EPA has developed guidance concerning submissions for import tolerance support (65 FR 35069, June 1, 2000) (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/.

4. 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). 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 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 Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), the Agency previously assessed whether revocations of tolerances for previously canceled uses 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), 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 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, 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, pesticides and pest.

   Dated: June 19, 2001. Marcia E. Mulkey, Director, Office of Pesticide Programs.

   Therefore, it is proposed that 40 CFR part 180 be amended as follows:

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   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 180.380 is amended by removing from the table in paragraph (a) the entries for ``cucumbers'', ``peppers (bell)'', ``stonefruits, except plums/fresh prunes'' and ``strawberries'', and by adding paragraph (e) to read as follows.

      Sec. 180.380 Vinclozolin; tolerances for residues.

      * * * * *

      (e) Revoked tolerances subject to the channel of trade provisions. The following table lists commodities with residues of vinclozolin resulting from lawful use are subject to the channels of trade provisions of section 408(1)(5) of the FFDCA:

      Parts per Commodity

      million

      Cucumbers....................................................

      1.0 Peppers (bell)...............................................

      3.0 Stonefruits, except plums/fresh prunes....................... 25.0 Strawberries................................................. 10.0

      [FR Doc. 01-16955Filed7-9-01; 8:45 am]

      BILLING CODE 6560-50-S