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

[Federal Register: May 24, 1999 (Volume 64, Number 99)]

[Proposed Rules]

[Page 27943-27947]

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

[DOCID:fr24my99-25]

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300868; FRL-6083-3]

RIN 2070-AC18

Formaldehyde; Proposed Revocation of Exemptions from the Requirement of Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

SUMMARY: This document proposes to revoke exemptions from the requirement of tolerances for residues found in 40 CFR 180.1032 for formaldehyde or a mixture of methylene bispropionate and oxy(bismethylene) bispropionate in or on the grains of barley, corn, oats, sorghum, and wheat and the forages of alfalfa, bermuda grass, bluegrass, brome grass, clover, cowpea hay, fescue, lespedeza, lupines, orchard grass, peanut hay, peavine hay, rye grass, soybean hay, sudan grass, timothy, and vetch from postharvest application use as a fungicide to treat animal feeds. This action is being taken because there are no registered uses for formaldehyde on these commodities. EPA expects to determine whether any individuals or groups want to support these exemptions. The regulatory actions in this proposal 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 proposed in this document pertain to the proposed revocation of 22 exemptions, which would be counted among reassessments made toward the August 1999 review deadline of FFDCA section 408(q), as amended by the Food Quality Protection Act (FQPA) of 1996.

DATES: Comments must be received on or before July 23, 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 this proposal.

FOR FURTHER INFORMATION CONTACT: Phil Budig, Special Review Branch (7508C), Special Review and Reregistration Division, Office of Pesticide Programs, U.S. Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. Office location: Special Review Branch, CM #2, 6th floor, 1921 Jefferson Davis Hwy., Arlington, VA, Telephone: (703) 308-8029; e-mail: budig.phil@epa.gov. SUPPLEMENTARY INFORMATION:

1. What Is the Contribution to Tolerance Reassessment?

   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. As of March 1999, EPA has reassessed over 2,400 tolerances. The regulatory actions proposed in this document pertain to the proposed revocation of 22 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.

2. Does This Proposal Apply To Me?

   You may be affected by this proposal 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. Potentially affected categories and entities may include, but are not limited to:

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   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 person listed in the ``FOR FURTHER INFORMATION CONTACT'' section.

3. 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/fedrgstr.

   2. In Person or by Phone

      If you have any questions or need additional information about this action, please contact the 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-300868, (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 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.

4. How Can I Respond To This Notice?

   1. How and To Whom Do I Submit Comments To?

      You may submit comments through the mail, in person, or electronically. Be sure to identify the appropriate docket control number (i.e., ``OPP-300868'') in your correspondence.

      1. By mail. Submit written comments, identified by the docket control number, OPP-300868, to: Public Information and Records Integrity Branch, Information Resources and Services Division (7502C), Office of Pesticide Programs, U.S. Environmental Protection Agency, 401 M St., SW., Washington, DC 20460.

      2. In person or by courier. Deliver written comments, identified by the docket control number, OPP-300868, to: Public Information and Records Integrity Branch, Office of Pesticide Programs, U.S. Environmental Protection Agency, Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA.

      3. Electronically. Submit your comments and/or data electronically by E-mail to: opp-docket@epa.gov. Do not submit any information electronically that you consider to be Confidential Business Information (CBI). Submit electronic comments in ASCII file format, avoiding the use of special characters and any form of encryption. Comment and data will also be accepted on standard computer disks in WordPerfect 5.1/6.1 or ASCII file format. All comments and data in electronic form must be identified by the appropriate docket control number, OPP-300868. You may also file electronic comments and data online at many Federal Depository Libraries.

   2. How Should I Handle CBI Information In My Comments?

      You may claim information you submit 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. A copy of the comment that does not contain CBI must be submitted for inclusion in the public record. Information not marked confidential will be included in the public docket by EPA without prior notice. If you have any questions about CBI or the procedures for claiming CBI, please consult with the person identified in the ``FOR FURTHER INFORMATION CONTACT'' section.

5. What Is A ``Tolerance''?

   A ``tolerance'' represents the maximum level for residues of pesticide chemicals in or on raw agricultural commodities and processed foods. Section 408 of FFDCA, 21 U.S.C. 301 et seq., as amended by the FQPA of 1996, Public Law 104-170, authorizes the establishment of tolerances (maximum residue levels), exemptions from the requirement of a tolerance, modifications in tolerances, and revocation of tolerances for residues of pesticide chemicals in or on raw agricultural commodities and processed foods (21 U.S.C. 346(a)). Without a tolerance or exemption, food containing pesticide residues is considered to be unsafe and therefore ``adulterated'' under section 402(a) of the FFDCA. If food containing pesticide residues is considered to be ``adulterated,'' you cannot distribute the product in interstate commerce (21 U.S.C. 331(a) and 342(a)). For a food-use pesticide to be sold and distributed, the pesticide must not only have appropriate tolerances under the FFDCA, but also must be registered under section 3 of FIFRA (7 U.S.C. et seq.). To retain these tolerances and exemptions, EPA must make a finding that the tolerances and exemptions are safe. To make this safety finding, EPA needs data and information indicating that there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide residues covered by the tolerances and exemptions.

   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.

6. Why Is EPA Proposing the Tolerance Actions Discussed Below?

   EPA is proposing to revoke exemptions from the requirement of tolerances for residues of formaldehyde on commodities listed in 40 CFR 180.1032 because no active registrations exist for these uses. None of these commodities have been on an active formaldehyde label since 1994.

   It is EPA's general practice to propose revocation of tolerances and tolerance exemptions for residues of pesticide active ingredients on crop uses for

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   which FIFRA registrations no longer exist. EPA has historically expressed a concern that retention of tolerances and exemptions 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. However, in accordance with FFDCA section 408, EPA will not revoke any tolerance or exemption proposed for revocation if any person demonstrates a need for the retention of the tolerance, and if retention of the tolerance will meet the tolerance standard established under FQPA. Generally, interested parties support the retention of such tolerances and exemptions in order to permit treated commodities to be legally imported into the United States, since raw agricultural commodities or processed food or feed commodities containing pesticide residues not covered by a tolerance or exemption are considered to be adulterated.

   Tolerances and exemptions established for pesticide chemicals with FIFRA registrations cover residues in or on both domestic and imported commodities. To retain these tolerances and exemptions, EPA must make a finding that the tolerances and exemptions are safe. To make this safety finding, EPA needs data and information indicating that there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide residues covered by the tolerances and exemptions.

   To assure that all food marketed in the U.S. is safe, under FFDCA, EPA requires the same technical chemistry and toxicology data for such import tolerances (tolerances without related U.S. registrations) as are required to support U.S. food use registrations and any resulting tolerances. In addition, EPA requires residue chemistry data (crop field trials) that are representative of growing conditions in exporting countries in the same manner that EPA requires representative residue chemistry data from different U.S. regions to support domestic use of the pesticide and tolerance. Interested parties should contact EPA for written guidance on adapting U.S. residue chemistry data requirements to non-U.S. growing conditions in order to support an import tolerance.

7. Which Pesticides Are Covered By This Action?

   Formaldehyde is an antimicrobial fungicide and germicide used as a non-food disinfect.

8. What Action Is Being Taken?

   EPA is proposing to revoke exemptions from the requirement of tolerances established under section 408 of FFDCA for residues of formaldehyde in or on the grains of barley, corn, oats, sorghum, and wheat, and the forages of alfalfa bermuda grass, bluegrass, brome grass, clover, cowpea hay, fescue, lespedeza, lupines, orchard grass, peanut hay, peavine hay, rye grass, soybean hay, sudan grass, timothy, and vetch from postharvest application of formaldehyde or a mixture of methylene bispropionate and oxy(bismethylene) bispropionate when used as a fungicide. These exemptions apply only to use of the exempted tolerances as animal feeds. The Agency is proposing to revoke the exemptions for formaldehyde by removing 40 CFR 180.1032.

9. When Do These Actions Become Effective?

   EPA proposes that these actions become effective 90 days following publication of a final rule in the Federal Register. EPA is proposing the effective date because EPA believes that, by the date, all existing stocks of pesticide products labeled for uses associated with the tolerances proposed for revocation will have been exhausted for more than 1 year, giving ample time for any treated products to clear trade channels. None of these commodities have been on an active formaldehyde label since 1994. Therefore, EPA believes the effective date proposed in this document--90 days following publication of the final rule-- should be reasonable. However, if EPA is presented with information that there would be existing stocks still available for use after the expiration date and that the information is verified, EPA will consider extending the expiration date of the tolerance. If you have comments regarding existing stocks, please submit comments as described in Unit IV. of this proposal.

   Any commodities listed in this document that are treated with the pesticide subject to this proposal, and are in the channels of trade following the tolerance revocations, shall be subject to FFDCA section 408(1)(5), as established by FQPA. Under this section, any residue of the pesticide 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 a tolerance. Evidence to show that food was lawfully treated may include records that verify the dates the pesticide was applied to such food.

10. What Can I Do If I Wish the Agency to Maintain a Tolerance that the Agency Proposes to Revoke?

    In addition to submitting comments in response to this proposal, you may also submit an objection. EPA subsequently issues a final rule after considering the comments that are submitted in response to this proposal. If you fail to file an objection to the final rule within the time period specified, you will have waived the right to raise any issues resolved in the final rule. After the specified time, issues resolved in the final rule cannot be raised again in any subsequent proceedings.

    This proposed rule provides a comment period of 60 days for any interested person to demonstrate a need for retaining a tolerance, if retention of the tolerance will meet the tolerance standard established under FQPA. If EPA receives a comment to that effect, EPA will not proceed to revoke the tolerance immediately. However, EPA will take steps to ensure the submission of any needed supporting data and will issue an order in the Federal Register under FFDCA section 408(f), if needed. The order would specify the data needed and time frames for its submission, and would require that within 90 days some person or persons notify EPA that they will submit the data. If the data are not submitted as required in the order, EPA will take appropriate action under FIFRA or FFDCA.

11. How Do the Regulatory Assessment Requirements Apply to This Action?

    1. Is This a Significant Regulatory Action Involving Health and Safety Risks To Children?

       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, in general, tolerance actions 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 proposed 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

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       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 protection of infants and children, unless reliable data support a different safety factor.

    2. Does This Proposed Action Contain Any Reporting or Recordkeeping Requirements?

       No. This proposed 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 Proposed Action Involve Any ``Unfunded Mandates''?

       No. This proposed 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 (Public Law 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 Proposed Document?

       No. Under Executive Order 12875, entitled Enhancing Intergovernmental Partnerships (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 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 regulatory proposals containing significant unfunded mandates.''

       Today's proposed rule does not create an unfunded Federal mandate on State, local, or tribal governments. The proposed 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 proposed 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 proposed 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 proposed rule.

    5. Does This Action Involve Any Environmental Justice Issues?

       No. This proposed rule does not involve special consideration 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 Proposed Action Have a Potentially Significant Impact on a Substantial Number of Small Entities?

       No. The Agency has certified that tolerance actions, including the proposed 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 Proposed Action Involve Technical Standards?

       No. This proposed 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), Pubic Law 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. EPA invites public comment on this conclusion.

    8. Are There Any International Trade Issues Raised By This Action?

       These proposed revocations will not become final if comments are received which demonstrate the need to maintain the tolerance to cover residues in or on imported commodities. However, data must be submitted supporting the continued tolerance. 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. EPA is developing a guidance concerning submissions for import tolerance support. This guidance will be made available to interested parties.

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1. Is This Proposed Action Subject to Review Under the Congressional Review Act?

   No. This action is not a final rule. Under 5 U.S.C. 801(a)(1)(A) of the Administrative Procedure Act (APA), as amended by the Small Business Regulatory Enforcement Fairness Act of 1996 (Title II of Public Law 104-121, 110 Stat. 847), only final rules must be submitted to the U.S. Senate, U.S. House of Representatives, and Comptroller General of the United States prior to publication in the Federal Register.

   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 18, 1999. Lois A. Rossi, Director, Special Review and Reregistration Division, Office of Pesticide Programs.

   Therefore, it is proposed that 40 CFR part 180 be amended to read 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.

      Sec. 180.1032 [Removed]

   2. By removing Sec. 180.1032.

      [FR Doc. 99-13056Filed5-21-99; 8:45 am]

      BILLING CODE 6560-50-F