EPA Pesticide Program Updates: January 5, 2001

EPA Notice: Methyl Parathion: Notice of Pesticide Tolerance Revocation—Final Rule

Federal Register: January 5, 2001 (Volume 66, Number 4) Notices [Page 1241-1246]

ENVIRONMENTAL PROTECTION AGENCY
[OPP-301076; FRL-6752-6 RIN 2070 - AB78]

AGENCY: Environmental Protection Agency (EPA)

ACTION: Final Rule

SUMMARY: The Environmental Protection Agency previously published in the Federal Register a proposed rule, proposing to revoke methyl parathion tolerances for several commodities. This document announces the revocation of tolerances for the insecticide methyl parathion on the following commodities: Apples, artichokes, beets (greens alone), beets (with or without tops), birdsfoot trefoil forage, birdsfoot trefoil hay, broccoli, Brussels sprouts, carrots, cauliflower, celery, cherries, collards, grapes, kale, lentils, kohlrabi, lettuce, mustard green, nectarines, peaches, pears, plums (fresh prunes), rutabagas (with or without tops), rutabaga tops, spinach, tomatoes, turnips (with or without tops), turnips greens, vegetables leafy Brassica (cole), and vetch. Additionally, EPA is amending the following tolerances: beans(amend to beans, dried), peas (amend to peas, dried) so that methyl parathion is not used on succulent beans and peas. Note that methyl parathion may still be used on lentils; however, residues on lentils are covered by the tolerance for peas, dried. Foods legally treated with methyl parathion may continue to be marketed under the provisions of the Federal Food, Drug, and Cosmetic Act (FFDCA). 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 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 FFDCA, 21 U.S.C.346a. EPA is revoking these tolerances because the Agency has canceled the pesticide registrations under FIFRA, 7 U.S.C. 136 et seq., associated with them.

DATES: This regulation is effective January 5, 2001. Objections and requests for hearings, identified by docket control number OPP-301076, must be received by EPA on or before March 6, 2001.

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 VI. of the SUPPLEMENTARY INFORMATION. To ensure proper receipt by EPA, your objections and hearing requests must identify docket control number OPP-301076 in the subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT BY MAIL: Laura Parsons, Special Review and Registration Division (7508C), Office of Pesticide Programs, Environmental Protection Agency,
200 Pennsylvania Ave., NW., Washington, D.C. 20460; Telephone number: 703-305-5776 and
e-mail address: parsons.laura@epa.gov.

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:

This listing is not intended to be exhaustive, but rather provides 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. 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.

2. In person. The Agency has established an official record for this action under docket control number OPP-301076. 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.

II. Background

A. What Action is the Agency Taking?

In August 1999, the methyl parathion registrants submitted requests to voluntarily cancel registration of products containing methyl parathion for certain uses as the result of an agreement reached between EPA and the registrants. Given the risks associated with use of methyl parathion under the existing terms and conditions of use, EPA granted the requests for voluntary cancellation. On October 27, 1999, EPA published a notice in the Federal Register (64 FR 578771) (FRL-6387-8) announcing the cancellation of all methyl parathion uses on fruits and most uses on vegetables. The notice of voluntary cancellation, the date of allowable use, and the intent to revoke the methyl parathion tolerances were widely publicized. USDA sent notification to our trading partners through the World Trade Organization notification procedures. EPA also notified the regulatory authorities in over 145 countries as per FIFRA 17(b). For the canceled uses, existing stock of methyl parathion was allowed to be used until December 31, 1999.

On August 2, 1999 the EPA Administrator stated that while the current food supply is safe, the cancellation of certain uses of methyl parathion makes the food supply safer. This action is part of EPA's overall effort to reduce risks to the food supply under the Congressional mandate imposed by FQPA.

B. Comments Received on Proposed Revocation

In the Federal Register of June 2, 2000 (65 FR 35307) (FRL-6491-9), EPA issued a proposed rule to revoke the tolerances listed in this final rule. In response to this document, nine parties submitted comments. Comments were received from Knouse Foods, Minor Crop Farmer Alliance, National Food Processors Association, The California Pistachio Commission, Elf Atochem, The Almond Hullers and Processors Association, Consultants in Toxicology, Risk Assessment and Product Safety (CTRAPS), The European Commission, and Jellinek, Swartz and Connelly representing the registrant, Cheminova.

Seven of the commenters addressed one or both of two issues. The first is whether the FQPA section 408(l)(2), which requires revocation of tolerances for dietary risk based cancellations within 180 days of the last legal use, applies to voluntary cancellations. The methyl parathion registrants agreed upon use cancellations after considering the dietary risk assessment which showed unacceptably high levels of methyl parathion in foods. The commenters stated that "Congress did not intend for 408 (l)(2) to apply to voluntary cancellations.''

Response. EPA interprets 408(l)(2) of FDCA to apply to both cancellations effected through FIFRA 6(f) (voluntary action by a registrant) and those effected through FIFRA 6(b) (an Agency initiated cancellation action), provided that the cancellation is related to dietary risk. The Agency would point out that most cancellations are voluntary in nature, even when related to dietary risk, and we believe that congressional intent was to provide guidance on how to handle the majority of cases.

The second issue is that not all of the uses contributed to the dietary risk and therefore, only tolerances which contribute heavily to dietary risk should be included in the 408(l)(2) revocation.

Response. The Agency agrees that certain uses contributed more heavily towards dietary risk to children than other uses; in fact, certain uses considered alone exceeded the allowable dietary level. However, since the Agency is concerned with risk which is aggregated from all dietary sources, it is not possible to separate particular tolerances as exempt from 408(l)(2) because their contribution to dietary risk is less than from other commodities Two additional comments were received. The European Union comment addressed the timing of the action and requested that the Agency postpone this action until after the JMPR Codex Review of methyl parathion scheduled for the autumn of 2000 so as to not give the appearance that this is "an emergency action.''

Response. While the Agency agrees that the tolerance revocation is not an emergency situation, the Agency is required to take this action in accordance with the timing requirements of FFDCA section 408(l)(2). Consultants in Toxicology, Risk Assessment and Product Safety submitted a comment addressing the methodology of the methyl parathion risk assessment suggesting that the Agency should follow a degradate of methyl parathion, p-nitrophenol, in the general population instead of trying to predict dietary exposures from residues on food items.

Response. P-nitrophenol is metabolized from several pharmaceutical and pesticidal compounds, including methyl parathion. EPA prefers to use risk assessment methodologies which are as specific to the compound as possible in order to accurately characterize the risk.

C. Comments Received on Other Issues Relating to the Methyl Parathion Cancellation.

The Federal Register proposal ((65 FR 35307, June 2, 2000) (FRL 6491-9) Methyl Parathion; Notice of Proposed Tolerance Revocations and Channels of Trade Provision Guidance) also sought comment on alternate approaches for avoiding any potential problems to commerce or trade caused by revocation of these tolerances, and also provided an opportunity for interested parties to comment on the methyl parathion registrants requests to cancel various methyl parathion uses. No comments were received which addressed either of these issues.

D. 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 (RACs) 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 RACs 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 food-use pesticide to be sold and distributed, the pesticide must be registered under section 3, section 5, or 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.

E. When do These Actions Become Effective?

The tolerance revocation is effective on January 5, 2001. Any commodities listed in the regulatory text of this document that are treated with methyl parathion, 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 methyl parathion 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 methyl parathion.

F. 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 methyl parathion 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.

G. 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 April 25, 2000, EPA has assessed over 3,471 tolerances. This document removes 1 (the tolerance for lentils which is covered by the tolerance for peas, dried) and revokes 30 methyl parathion tolerances. However, 27 of these 30 tolerances are expressed as parathion which, as previously defined, may be either ethyl parathion or methyl parathion (this rule redefines those tolerances to include only ethyl parathion); only 3 of the 30 tolerances are methyl parathion alone. Therefore, three tolerances will be counted among reassessments made toward the August, 2002 review deadline of FFDCA section 408(q), as amended by the Food Quality Protection Act (FQPA) of 1996.

III. Are There Any International Trade Issues Raised by this Final Action?

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. When possible, EPA seeks to harmonize U.S. tolerances with Codex MRLs. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain in a Federal Register document the reasons for departing from the Codex level. EPA's effort to harmonize with Codex MRLs is summarized in the tolerance reassessment section of individual reregistration eligibility decision documents or other documents which reassess tolerances. The U.S. EPA has developed guidance concerning submissions for import tolerance support. This guidance will be made available to interested persons.

IV. Objections and Hearing Requests

Under section 408(g) of the FFDCA, as amended by the FQPA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178.

A. 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 control number OPP-301076 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 March 6, 2001.

1. 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, D.C. 20460. You may also deliver your request to the Office of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St., SW., Washington, D.C. 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.

2. 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 tompkins.jim@epa.gov, or by mailing a request for information to Mr. Tompkins, Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, D.C. 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, D.C. 20460.

3. Copies for the docket. In addition to filing an objection or hearing request with the Hearing Clerk as described in Unit IV.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 control number OPP-301076, 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, D.C. 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: opp-docket@epa.gov. 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 file format 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.

B. 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).

V. Regulatory Assessment Requirements

This final rule will revoke tolerances under FFDCA section 408. The Office of Management and Budget (OMB) has exempted this type of action, i.e. a tolerance revocations for which extraordinary circumstances do not exist, from review under Executive Order 12866, entitled Regulatory Planning and Review October 4, 1993 (58 FR 51735). 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 prior consultation as specified by Executive Order 13084, entitled Consultation and Coordination with Indian Tribal Governments May 19, 1998 (63 FR 27655); special considerations as required by Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations February 16, 1994 (59 FR 7629); or require OMB review or any Agency action under Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks April 23, 1997 (62 FR 19885). 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, the EPA certifies 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 will not be a significant economic impact on a substantial number of small produce importing businesses. Furthermore, the Agency knows of no extraordinary circumstances that exist as to the present revocation 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 August 10, 1999 (64 FR 43255). 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).

VI. 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: December 20, 2000.
Marcia E. Mulkey,
Director, Office of Pesticide Programs.

Therefore, 40 CFR part 180 is amended as follows:
PART 180--[AMENDED]
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), (346a) and 371.
2. Section 180.121 is revised to read as follows:
Sec. 180.121 Parathion or its methyl homolog; tolerances for residues

(b) Section 18 emergency exemptions. [Reserved]
(c) Tolerances with regional registrations. [Reserved]
(d) Indirect or inadvertent residues. [Reserved]
(e) Revoked tolerances subject to the channel of trade provisions.

Federal Register: January 5, 2001 (Volume 66, Number 4, Page 1241-1246)
DOCID:fr05ja01-18
40 CFR Part 180
[OPP-301076; FRL-6753-6]
RIN 2070 - AB78
From the Federal Register Online via GPO Access [wais.access.gpo.gov]