Pesticides; tolerances in food, animal feeds, and raw agricultural commodities: crotonamide (monocrotophos),

[Federal Register: April 21, 1999 (Volume 64, Number 76)]

[Rules and Regulations]

[Page 19489-19493]

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

[DOCID:fr21ap99-7]

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 180 and 185

[OPP-300836; FRL-6074-4]

RIN 2070-AB78

Dimethyl phosphate of 3-hydroxy-N-methyl-cis-crotonamide (monocrotophos) Final rule; Tolerance Revocations

AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule.

SUMMARY: This final rule announces the revocation of tolerances for Dimethyl phosphate of 3-hydroxy-N-methyl-cis-crotonamide (monocrotophos) for residues of sugarcane, potatoes, cotton seed, peanuts, peanut hulls, and tomatoes. 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).

By law, EPA is required to reassess 33% of the tolerances in existence on August 2, 1996, by August 1999, or about 3,200 tolerances. The regulatory actions indicated in this document pertain to the final revocation of tolerances and/or exemptions, which count toward the August, 1999, review deadline of FFDCA section 408(q), as amended by the Food Quality Protection Act (FQPA) of 1996. DATES: This regulation becomes effective April 21, 1999. Objections and requests for hearings must be received on or before July 20, 1999. ADDRESSES: Comments may be submitted by mail, electronically, or in person. Please follow the detailed instructions for each method as provided in Unit IV of the SUPPLEMENTARY INFORMATION section of this notice. Be sure to identify the appropriate docket number [OPP-300836], which is an addendum to a previous docket. FOR FURTHER INFORMATION CONTACT: For technical information contact: Jamil Mixon, Reregistration Branch I, mail code (7508C), Special Review and Reregistration Division, Office of Pesticide Programs, U.S. Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. Office location: Reregistration Branch I, CM #2, 6th floor, 1921 Jefferson Davis Hwy., Arlington, VA. Telephone: (703) 308-8032; e-mail: mixon.jamil @epa.gov. SUPPLEMENTARY INFORMATION:

1. Does this Notice Apply to Me?

   You may be affected by this notice if you sell, distribute, manufacture, or use pesticides for agricultural applications, process food, distribute or sell food, or implement governmental pesticide regulations. Pesticide reregistration and other actions [see FIFRA section 4(g)(2)] include tolerance and exemption reassessment under FFDCA section 408. In this notice, the tolerance actions are proposed in coordination with the cancellation of associated registrations. Potentially affected categories and entities may include, but are not limited to:

   Examples of Potentially Category

   Affected Entities

   Agricultural Stakeholders................ Growers/Agricultural Workers Contractors [Certified/ Commercial Applicators, Handlers, Advisors, etc.] Commercial Processors Pesticide Manufacturers User Groups Food Consumers

   Food Distributors......................... Wholesale Contractors Retail Vendors Commercial Traders/ Importers

   Intergovernmental Stakeholders............ State, Local, and/or Tribal Government Agencies Foreign Entities.......................... Governments, Growers, Trade Groups

   This table is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this table could also be affected. If you have any questions regarding the applicability of this action to a particular entity, you can consult with the technical person listed in the ``FOR FURTHER INFORMATION CONTACT'' section.

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2. How Can I Get Additional Information or Copies of this or Other Support Documents?

   1. Electronically

      You may obtain electronic copies of this document and various support documents from the EPA Internet Home Page at http:// www.epa.gov/. On the Home Page select ``Laws and Regulations'' 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/homepage/fedrgstr/.

   2. In Person or by Phone

      If you have any questions or need additional information about this action, please contact the technical person identified in the ``FOR FURTHER INFORMATION CONTACT'' section. In addition, the official record for this notice, including the public version, has been established under docket control number [OPP-300836], (including comments and data submitted electronically as described below). A public version of this record, including printed, paper versions of any electronic comments, which does not include any information claimed as Confidential Business Information (CBI), is available for inspection in Room 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 Public Information and Records Integrity Branch telephone number is 703-305- 5805.

3. Can I Challenge the Agency's Final Decision Presented in this Document?

   Yes. You can file a written objection or request a hearing by June 21, 1999 in the following manner:

   1. By Paper

      Written objections and hearing requests, identified by the document control number [OPP-300836], may be submitted to: Hearing Clerk (1900), Environmental Protection Agency, room M3708, 401 M St., SW., Washington, DC 20460. Fees accompanying objections and hearing requests shall be labeled ``Tolerance Petition Fees'' and forwarded to: EPA Headquarters Accounting Operations Branch, OPP (Tolerance Fees), P.O. Box 360277M, Pittsburgh, PA 15251. A copy of any objections and hearing requests filedwith the Hearing Clerk should be identified by the document control number and submitted to the Public Information and Records Integrity Branch, Information Resources and Services Division (7502C), Office of Pesticide Programs, 401 M St., SW., Washington, DC 20460. In person, bring a copy of objections and hearing requests to room 119, CM #2, 1921 Jefferson Davis Hwy., Arlington, VA 22202.

   2. Electronically

      A copy of objections and hearing requests filedwith the Hearing Clerk may also be submitted electronically by sending e-mail to opp- docket@epamail.epa.gov, per the instructions given in ``By Paper'' above. Electronic copies of objections and hearing requests must be submitted as an ASCII file avoiding the use of special characters and any form of encryption. Copies of objections and hearing requests will also be accepted on disks in WordPerfect 5.1 or 6.1 file format or ASCII file format. All copies of objections and hearing requests in electronic form must be identified by the docket number [OPP-300836]. Do not submit CBI through e-mail. Electronic copies of objections and hearing requests on this rule may be filedonline at many Federal Depository libraries.

4. Why Is EPA Revoking the Tolerances Discussed below?

   On June 13, 1988, the producer of monocrotophos requested voluntary cancellation of all registrations with a recall of all products in the channels of trade that would not be used by September 30, 1989. The last registered uses for monocrotophos were cancelled on January 22, 1991, for nonpayment of the March 1, 1990, maintenance fees. On June 9, 1993, the Agency's proposed revocation of tolerances for monocrotophos was published in the Federal Register (FRL-4183-6). Comments were received from Ciba-Geigy Corporation, now Novartis Crop Protection, Inc. and Biologic Research & Development Inc., a U.S. regulatory consultant for the Shell International Chemical Company, expressing strong interest in maintaining tolerance on commodities imported into the United States. As a result, the Agency allowed tolerances to remain on peanut hulls, cottonseed, potatoes, sugarcane, and tomatoes.

   On January 22, 1999, Novartis Crop Protection Inc. the sole producer of monocrotophos, informed EPA that it no longer intended to support monocrotophos tolerances for import purposes. Novartis indicates that sale of monocrotophos will end in 1999, and has requested that tolerances for import purposes be retained until December 31, 2000, in order to fully utilize their existing stock. As Novartis is the sole producer of monocrotophos, EPA believes that there is no one else who will support tolerances for monocrotophos for import commodities. Therefore, EPA is revoking these tolerances for monocrotophos in or on peanuts, peanut hulls, tomatoes, cottonseed, potatoes and sugarcane (Sec. 180.296) and in concentrated tomato products (Sec. 185.2250).

5. What Action Is Being Taken?

   This final rule revokes the FFDCA tolerances for residues of certain specified pesticides in or on certain specified commodities. EPA is revoking these tolerances because they are not necessary to cover residues of the relevant pesticides in or on domestically treated commodities or commodities treated outside but imported into the United States. These pesticides are no longer used on commodities within the United States and no person has provided comment identifying a need for EPA to retain the tolerances to cover residues in or on imported foods. EPA has historically expressed a concern that retention of tolerances that are not necessary to cover residues in or on legally treated foods has the potential to encourage misuse of pesticides within the United States. Thus it is EPA's policy to issue a final rule revoking those tolerances for residues of pesticide chemicals for which there are no active registrations under FIFRA, unless any person in comments on the proposal demonstrates a need for the tolerance to cover residues in or on imported commodities or domestic commodities legally treated.

   EPA is not issuing today a final rule to revoke those tolerances for which EPA received comments demonstrating a need for the tolerance to be retained. Generally, EPA will proceed with the revocation of these tolerances on the grounds discussed above only if, prior to EPA's issuance of a section 408(f) order requesting additional data or issuance of a section 408(d) or (e) order revoking the tolerances on other grounds, commenters retract the comment identifying a need for the tolerance to be retained or EPA independently verifies that the tolerance is no longer needed.

   In the Federal Register of June 9, 1993, (OPP-300836) (FRL 4183-6), EPA issued a proposed rule for specific pesticides announcing the proposed revocation of tolerances for canceled food uses and inviting public comment for consideration and for support of tolerance retention under FFDCA standards. The following comments were received by the agency in response

   [[Page 19491]]

   to the document published in the Federal Register: 1. Comments from a letter received from Ciba-Geigy Corporation July 27, 1993, stated that, `` Monocrotophos is used extensively in many countries around the world. The major uses in these countries are on crops such as sugarcane, potatoes and cottonseed.'' In addition Ciba-Geigy requested that, ``the Agency withhold preceding to revoke residue tolerances for monocrotophos on cottonseed, potatoes and sugarcane at this time. Revoking these tolerances could create a non tariff trade barrier and should therefore be avoided to the extent possible. Ciba's proposal is to convert these domestic tolerances `` to import tolerances which will help facilitate free trade.''

   Agency Response. The Agency allowed tolerances to remain on peanut hulls, tomatoes, cottonseed, potatoes and sugarcane (Sec. 180.296) and in concentrated tomato products (Sec. 185.2250).

   2. Comments from correspondence received August 4, 1993, from Biologic Research & Development Inc., than a U.S. regulatory consultant for the Shell International Chemical Company, requested that EPA reconsider its proposal to revoke the existing U.S. tolerances for monocrotophos, but rather allow for a review of those tolerances in recognition of on going international uses of this compound and those residues likely to occur in commodities imported into the U.S.

   Agency Response. The Agency allowed tolerances to remain on peanuts, peanut hulls, tomatoes, cottonseed, potatoes and sugarcane (Sec. 180.296) and in concentrated tomato products (Sec. 185.2250).

6. When do These Actions become Effective?

   Tolerance revocation for monocrotophos becomes effective December 31, 2000, per the manufacturer's request to fully utilize its remaining existing stock. If you have comments regarding existing stocks, please submit comments as described in Unit IV of the SUPPLEMENTARY INFORMATION section of this notice.

   Parts per Expiration/ Section

   Commodity

   million Revocation Date

   180.296....................................... Peanuts hulls

   0.5

   12/31/2000 ............................................ Tomatoes

   0.5

   12/31/2000 ............................................ Cottonseed

   0.1

   12/31/2000 ............................................ Potatoes

   0.1

   12/31/2000 ............................................ Sugarcane

   0.1

   12/31/2000 ............................................ Peanuts

   0.05

   12/31/2000 185.2250...................................... Tomato concentrated products

   2.0

   12/31/2000

   Any commodities listed in the regulatory text of this document that are treated with the pesticides subject to this notice, and that are in the channels of trade following the tolerance revocations, shall be subject to FFDCA section 408(1)(5), as established by the Food Quality Protection Act (FQPA). Under this section, any residue 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.

7. How do the regulatory assessment requirements apply to this action?

   1. Is this a ``Significant Regulatory Action''?

      No. Under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993), this action is not a ``significant regulatory action.'' The Office of Management and Budget (OMB) has determined that tolerance actions, in general, are not ``significant'' unless the action involves the revocation of a tolerance that may result in a substantial adverse and material affect on the economy. In addition, this action is not subject to Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997), because this action is not an economically significant regulatory action as defined by Executive Order 12866. Nonetheless, environmental health and safety risks to children are considered by the Agency when determining appropriate tolerances. Under FQPA, EPA is required to apply an additional 10-fold safety factor to risk assessments in order to ensure the protection of infants and children unless reliable data supports a different safety factor.

   2. Does this Action Contain Any Reporting or Recordkeeping Requirements?

      No. This action does not impose any information collection requirements subject to OMB review or approval pursuant to the Paperwork Reduction Act (44 U.S.C. 3501 et seq.).

   3. Does this Action Involve Any ``Unfunded Mandates''?

      No. This action does not impose any enforceable duty, or contain any ``unfunded mandates'' as described in Title II of the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4).

   4. Do Executive Orders 12875 and 13084 Require EPA to Consult with States and Indian Tribal Governments Prior to Taking the Action in this Document?

      No. Under Executive Order 12875, entitled Enhancing the Intergovernmental Partnership (58 FR 58093, October 28, 1993), EPA may not issue a regulation that is not required by statute and that creates a mandate upon a State, local or tribal government, unless the Federal government provides the funds necessary to pay the direct compliance costs incurred by those governments. If the mandate is unfunded, EPA must provide to the Office of Management and Budget (OMB) a description of the extent of EPA's prior consultation with representatives of affected State, local and tribal governments, the nature of their concerns, copies of any written communications from the governments, and a statement supporting the need to issue the regulation. In addition, Executive Order 12875 requires EPA to develop an effective process permitting elected officials and other representatives of State, local and tribal governments ``to provide meaningful and timely input in the development of

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      regulatory proposals containing significant unfunded mandates.''

      Today's rule does not create an unfunded Federal mandate on State, local or tribal governments. The rule does not impose any enforceable duties on these entities. Accordingly, the requirements of section 1(a) of Executive Order 12875 do not apply to this rule.

      Under Executive Order 13084, entitled Consultation and Coordination with Indian Tribal Governments (63 FR 27655, May 19, 1998), EPA may not issue a regulation that is not required by statute, that significantly or uniquely affects the communities of Indian tribal governments, and that imposes substantial direct compliance costs on those communities, unless the Federal government provides the funds necessary to pay the direct compliance costs incurred by the tribal governments. If the mandate is unfunded, EPA must provide OMB, in a separately identified section of the preamble to the rule, a description of the extent of EPA's prior consultation with representatives of affected tribal governments, a summary of the nature of their concerns, and a statement supporting the need to issue the regulation. In addition, Executive Order 13084 requires EPA to develop an effective process permitting elected and other representatives of Indian tribal governments ``to provide meaningful and timely input in the development of regulatory policies on matters that significantly or uniquely affect their communities.''

      Today's rule does not significantly or uniquely affect the communities of Indian tribal governments. This action does not involve or impose any requirements that affect Indian Tribes. Accordingly, the requirements of section 3(b) of Executive Order 13084 do not apply to this rule.

   5. Does Executive Order 12898 Apply to this Action?

      No. This final rule does not involve special considerations of environmental-justice related issues pursuant to Executive Order 12898, entitled ``Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations'' (59 FR 7629, February 16, 1994).

   6. Does this Action Have a Potentially Significant Impact on a Substantial Number of Small Entities?

      No. The Agency has certified that tolerance actions, including the tolerance actions in this document, are not likely to result in a significant adverse economic impact on a substantial number of small entities. The factual basis for the Agency's determination, along with its generic certification under section 605(b) of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), appears at 63 FR 55565, October 16, 1998 (FRL-6035-7). This generic certification has been provided to the Chief Counsel for Advocacy of the Small Business Administration.

   7. Does this Action Involve Technical Standards?

      No. This tolerance 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), Pub. L. 104-113, section 12(d) (15 U.S.C. 272 note). Section 12(d) directs EPA to use voluntary consensus standards in its regulatory activities unless to do so would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (e.g., materials specifications, test methods, sampling procedures, business practices, etc.) that are developed or adopted by voluntary consensus standards bodies. The NTTAA requires EPA to provide Congress, through OMB, explanations when the Agency decides not to use available and applicable voluntary consensus standards.

   8. Are There Any International Trade Issues Raised by this 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 REDs. The U.S. EPA is developing a guidance concerning submissions for import tolerance support. This guidance will be made available to interested stakeholders.

1. Is this Action Subject to Review under the Congressional Review Act?

   Yes. The Congressional Review Act, 5 U.S.C. Sec. 801 et seq., as amended 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 the rule in the Federal Register. This action is not a ``major rule'' as defined by 5 U.S.C. 804(2).

   List of Subjects

   40 CFR Part 180

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

   40 CFR Part 185

   Environmental protection, Food additive, Pesticides and pest.

   Dated: April 12, 1999. Lois Rossi, Director, Special Review and Reregistration Division, Office of Pesticide Programs.

   Therefore, 40 CFR parts 180 and 185 are amended as follows:

   PART 180--[AMENDED]

   1. In part 180:

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

      Authority: 21 U.S.C. 321(q), 346(a) and 374.

   2. By revising Sec. 180.296 to read as follows:

      Sec. 180.296 Dimethyl phosphate of 3-hydroxy-N-methyl-cis-crotonamide; tolerance for residues.

      (a) General. Tolerances are established for residues of the insecticide Dimethyl phosphate of 3-hydroxy-N-methyl-cis-crotonamide in or on the following raw agricultural commodities:

      Expiration/ Commodity

      Parts per Revocation million date

      Cottonseed......................................

      0.1 12/31/00 Peanuts......................................... 0.05 12/31/00

      [[Page 19493]]

      Potatoes........................................

      0.1 12/31/00 Sugarcane.......................................

      0.1 12/31/00 Tomato..........................................

      0.5 12/31/00 Tomato, concentrated products...................

      2.0 12/31/00

      (b) Section 18 emergency exemptions. [Reserved]

      (c) Tolerances with regional registrations. [Reserved]

      (d) Indirect or inadvertent residues. [Reserved] 2. In part 185:

      PART 185-- [AMENDED]

   1. The authority citation for part 185 is revised to read as follows: Authority: 21 U.S.C. 346(a) and 348.

      Sec. 185.2250 [Removed]

   2. By removing Sec. 185.2250 Dimethyl phosphate of 3-hydroxy-N- methyl-cis-crotonamide; tolerance for residues.

      [FR Doc. 99-10006Filed4-20-99; 8:45 am]

      BILLING CODE 6560-50-F