Pesticides; tolerances in food, animal feeds, and raw agricultural commodities: Vinclozolin,
[Federal Register: June 12, 2002 (Volume 67, Number 113)]
[Rules and Regulations]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
Vinclozolin; Tolerance Revocations and Notice of Channels of Trade Provision Guidance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
SUMMARY: This final rule revises the tolerances listed in the regulatory text for the fungicide vinclozolin (40 CFR 180.380) by revoking the tolerances in or on strawberries, stone fruits, cucumbers, and bell peppers. The Environmental Protection Agency previously published a notice proposing to revoke these four tolerances, subject to public comment, in the Federal Register on July 10, 2001 (FRL-67797- 7). The regulatory actions 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).
The Food and Drug Administration (FDA) in a related notice published else where in this issue of the Federal Register is announcing the availability of a 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.
DATES: This final rule is effective June 12, 2002. Objections and requests for hearings, identified by docket ID number OPP-2002-0036, must be received by EPA on or before August 12, 2002.
ADDRESSES: Written objections and hearing requests may be submitted by mail, in person, or by courier. Please
follow the detailed instructions for each method as provided in Unit III. To ensure proper receipt by EPA, your objections and hearing requests must identify docket ID number OPP-2002-0036 in the subject line on the first page of your response.
FOR FURTHER INFORMATION CONTACT: By mail: Deanna Scher, Special Review and Reregistration 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: email@example.com.
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
Potentially Affected Entities
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.
How Can I Get Additional Information, Including Copies of this Document and Other Related Documents?
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--00/Title--40/40cfr180--00.html, a beta site currently under development.
In person. The Agency has established an official record for this action under docket ID number OPP-2002-0036. 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.
What Action is the Agency Taking?
This final rule revokes the FFDCA tolerances for residues of the fungicide vinclozolin in or on strawberries, stone fruits, cucumbers, and bell peppers. In the Federal Register of July 10, 2001 (66 FR 35921) (FRL-6779-7), EPA issued a proposed rule to revoke the tolerances listed in this final rule and invited public comment for consideration and for support of tolerance retention under FFDCA standards. No comments were received by the Agency during the 60-day comment period. The revocation is effective on the date of publication of this final rule.
On July 30, 1998, EPA published a notice in the Federal Register (63 FR 40710) (FRL-6020-9) announcing BASF Corporation's request to cancel the FIFRA registered uses for the pesticide vinclozolin on strawberries and stone fruits. These cancellations were precipitated by EPA's determination that aggregate exposure to vinclozolin exceeded the safety standard under FQPA. The notice informed the public of how it could comment on the request for cancellation. One comment was received from the California Strawberry Commission; this comment was fully addressed in a subsequent Federal Register notice (63 FR 59557) (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 stone fruit became unlawful after January 30, 2000. Therefore, no domestically treated commodities covered by these tolerances are expected to be in the channels of trade. No person has provided comments identifying a need for EPA to retain the tolerances to cover residues in or on imported strawberries or stone fruits.
On May 31, 2000, BASF Corporation requested that EPA revoke the import tolerances for cucumbers and bell peppers, as part of a risk mitigation proposal designed to address dietary and aggregate risk concerns identified during reregistration review. 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). Vinclozolin is not registered for use on bell peppers and cucumbers in the United States. No person has provided comment identifying a need for EPA to retain the tolerances to cover residues in or on imported cucumbers or bell peppers.
What is the Agency's Authority for Taking this Action?
It is EPA's general practice to propose revocation of tolerances for residues of pesticide active ingredients on crop uses for which FIFRA registrations no longer exist. 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.
When do These Actions Become Effective?
These actions become effective on June 12, 2002. 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), the ``channels of trade provision'' 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.
What Action is FDA Taking with Respect to the Tolerance Revocation?
The FDA in a related notice published elsewhere in this issue of the Federal Register is announcing the availability of a 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 section 408(l)(5) of the FFDCA that FDA may find satisfactory in accordance with its planned enforcement approach for such section.
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 May 15, 2002, EPA has reassessed over 4,570 tolerances. This document revokes four vinclozolin tolerances; however, the reassessments were previously counted in 1997 when all vinclozolin tolerances were reassessed in order to make a decision on a new tolerance petition. Consequently, no further vinclozolin reassessments, including these four revocations, count towards the August, 2002 review deadline of FFDCA section 408(q), as amended by the Food Quality Protection Act (FQPA) of 1996.
Objections and Hearing Requests
What Do I Need to Do to File an Objection or Request a Hearing?
You must file your objection or request a hearing on this regulation in accordance with the instructions provided in this unit and in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number OPP-2002-0036 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before August 12, 2002.
Filing the request. Your objection must specify the specific provisions in the regulation that you object to, and the grounds for the objections (40 CFR 178.25). If a hearing is requested, the objections must include a statement of the factual issues(s) on which a hearing is requested, the requestor's contentions on such issues, and a summary of any evidence relied upon by the objector (40 CFR 178.27). Information submitted in connection with an objection or hearing request may be claimed confidential 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. A copy of the information that does not contain CBI must be submitted for inclusion in the public record. Information not marked confidential may be disclosed publicly by EPA without prior notice.
Mail your written request to: Office of the Hearing Clerk (1900), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. You may also deliver your request to the Office of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St., SW., Washington, DC 20460. The Office of the Hearing Clerk is open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Office of the Hearing Clerk is (202) 260-4865.
Objection/hearing fee payment. If you file an objection or request a hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or request a waiver of that fee pursuant to 40 CFR 180.33(m). You must mail the fee to: EPA Headquarters Accounting Operations Branch, Office of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please identify the fee submission by labeling it ``Tolerance Petition Fees.''
EPA is authorized to waive any fee requirement ``when in the judgement of the Administrator such a waiver or refund is equitable and not contrary to the purpose of this subsection.'' For additional information regarding the waiver of these fees, you may contact James Tompkins by phone at (703) 305-5697, by e-mail at firstname.lastname@example.org, or by mailing a request for information to Mr. Tompkins at Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
If you would like to request a waiver of the tolerance objection fees, you must mail your request for such a waiver to: James Hollins, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
Copies for the Docket. In addition to filing an objection or hearing request with the Hearing Clerk as described in Unit III.A., you should also send a copy of your request to the PIRIB for its inclusion in the official record that is described in Unit I.B.2. Mail your copies, identified by docket ID number OPP-2002-0036, to: Public Information and Records Integrity Branch, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. In person or by courier, bring a copy to the location of the PIRIB described in Unit I.B.2. You may also send an electronic copy of your request via e-mail to: email@example.com. Please use an ASCII file format and avoid the use of special characters and any form of encryption. Copies of electronic objections and hearing requests will also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. Do not include any CBI in your electronic copy. You may also submit an electronic copy of your request at many Federal Depository Libraries.
When Will the Agency Grant a Request for a Hearing?
A request for a hearing will be granted if the Administrator determines that the material submitted shows the following: There is a genuine and substantial issue of fact; there is a reasonable possibility that available evidence identified by the requestor would, if established resolve one or more of such issues in favor of the requestor, taking into account uncontested claims or facts to the contrary; and resolution of the factual issues(s) in the manner sought by the requestor would be adequate to justify the action requested (40 CFR 178.32).
Regulatory Assessment Requirements
This final rule will revoke 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 final rule has been exempted from review under Executive Order 12866 due to its lack of significance, this final rule is not subject to Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor does it require any special considerations as required by Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and LowIncome 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 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), 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 revocations that would change EPA's previous analysis.
In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure ``meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.'' ``Policies that have federalism implications'' is defined in the Executive Order to include regulations that have ``substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.'' This final rule directly regulates growers, food processors, food handlers and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). For these same reasons, the Agency has determined that this rule does not have any ``tribal implications'' as described in Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure ``meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.'' ``Policies that have tribal implications'' is defined in the Executive Order to include regulations that have ``substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.'' This rule will not have substantial direct effects on tribal governments, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule.
Submission to Congress and the Comptroller General
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of this final rule in the Federal Register. This final rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.
Dated: May 20, 2002. Marcia E. Mulkey, Director, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346(a) and 371.
Section 180. is amended by removing from the table in paragraph (a) the entries for ``cucumbres'', ``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(l)(5) of the FFDCA:
Parts per million
1.0 Peppers (bell)
3.0 Stonefruits, except plums/fresh prunes 25.0 Strawberries
[FR Doc. 02-13520Filed6-11-02; 8:45 am]
BILLING CODE 6560-50-S