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

[Federal Register: June 11, 2003 (Volume 68, Number 112)]

[Rules and Regulations]

[Page 34825-34829]

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

[DOCID:fr11jn03-20]

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2003-0159; FRL-7309-5]

Methoprene, Watermelon Mosaic Virus-2 Coat Protein, and Zucchini Yellow Mosaic Virus Coat Protein; Final Tolerance Actions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

SUMMARY: EPA is amending the text of the exemption from the requirement of a tolerance for methoprene and is revoking all of the tolerances for residues for methoprene because a recent EPA review finds that no harm is expected to the public from exposure to residues of methoprene. Therefore, these tolerances are no longer needed and their associated uses are covered by tolerance exemptions. Also, EPA is revoking the exemptions for watermelon mosaic virus-2 coat protein, and zucchini yellow mosaic virus coat protein and specific portions of the viral genetic material when used as plant-incorporated protectants in squash, because these exemptions are covered in later sections of 40 CFR part 180. Because methoprene's 35 tolerances and the 2 exemptions from the virus materials were previously reassessed, the regulatory actions taken in this document do not contribute toward the Agency's tolerance reassessment requirements of the Federal Food, Drug, and Cosmetic Act (FFDCA) section 408(q), as amended by the Food Quality Protection Act (FQPA) of 1996. By law, EPA is required by August 2006 to reassess the tolerances in existence on August 2, 1996.

DATES: This regulation is effective June 11, 2003. Objections and requests for hearings, identified by docket ID

[[Page 34826]]

number OPP-2003-0159, must be received on or before August 11, 2003.

ADDRESSES: Written objections and hearing requests may be submitted electronically, by mail, or through hand delivery/courier. Follow the detailed instructions as provided in Unit IV. of the SUPPLEMENTARY INFORMATION.

FOR FURTHER INFORMATION CONTACT: Barbara Mandula, Biopesticides and Pollution Prevention Division (7511C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,Washington, DC 20460-0001; telephone number: (703) 308-7378; e-mail address: mandula.barbara@epa.gov. SUPPLEMENTARY INFORMATION:

1. General Information

   1. Does this Action Apply to Me?

      You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to:

      [sbull] Crop production (NAICS 111)

      [sbull] Animal production (NAICS 112)

      [sbull] Food manufacturing (NAICS 311)

      [sbull] Pesticide manufacturing (NAICS 32532)

      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 this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. To determine whether you or your business may be affected by this action, you should carefully examine the applicability provisions in Unit IIA. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT.

   2. How Can I Get Copies of this Document and Other Related Information?

      1. Docket. EPA has established an official public docket for this action under docket identification ID number OPP-2003-0159. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall 2, 1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The docket telephone number is (703) 305-5805.

      2. Electronic access. You may access this Federal Register document electronically through the EPA Internet under 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.

      An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I.B.1. Once in the system, select ``search,'' then key in the appropriate docket ID number.

2. Background

   1. What Action is the Agency Taking?

      In the Federal Register of February 12, 2003 (68 FR 7097) (FRL- 7288-7), EPA issued a proposed rule to amend the exemption expression for methoprene to indicate that methoprene is exempt from tolerances when used on food commodities as an insect larvicide, to revoke all the tolerances for residues of methoprene because they are no longer needed to protect the public, and to revoke the exemptions for watermelon mosaic virus-2 coat protein and zucchini yellow mosaic virus coat protein and specific portions of the viral genetic material when used as plant-incorporated protectants in squash, because these exemptions are covered in later sections of 40 CFR part 180. Also, the February 12, 2003 proposal provided a 60-day comment period which invited public comment for consideration and for support of tolerance retention under FFDCA standards. No comments were received.

      On August 1, 2002, EPA concluded that there is a reasonable certainty that no harm will result to the general population, infants, and children from aggregate exposure to residues of methoprene based on its review and evaluation of available information and conservative assumptions that assumed the existence of a broad-based tolerance exemption; i.e., that methoprene can be used on all crop commodities. In addition, EPA determined that all methoprene tolerances in 40 CFR 180.359 and its exemption in Sec. 180.1033 were considered to be reassessed. For reassessment counting purposes, the tolerance for the cereal grain milled fractions was counted as two to reflect the original tolerances found previously in 40 CFR 185.4150 and 186.4150. Methoprene is being granted a tolerance exemption for use as an insect larvicide on all food commodities based on the Agency's safety finding which supports tolerance exemption. The tolerances revoked by this final rule are no longer necessary for the continued use of methoprene as a pesticide. A copy of EPA's August 1, 2002 memo is available in e- docket OPP-2002-0274.

      EPA is aware that revocation of some of the methoprene tolerances leads to or continues a lack of harmonization with some of the existing methoprene CODEX maximum residue limits (MRLs). For egg, the EPA tolerance of 0.1 ppm is being revoked while the CODEX MRL remains at 0.05 milligrams/kilogram (mg/kg). For mushroom, EPA's tolerance of 1.0 ppm is being revoked while the CODEX MRL remains at 0.2 mg/kg. For peanut, EPA's tolerance of 2.0 ppm is being revoked while the CODEX MRL remains at 2 mg/kg. For residues of methoprene in other food commodities, there was either a tolerance or there is a CODEX MRL, but not both; therefore, a lack of harmonization remains for residues in these other food commodities.

      EPA is revoking the methoprene tolerances in all food commodities because a thorough risk analysis has shown that these tolerances are not necessary to protect human health or the environment. Risk assessments were performed for oral exposure for acute, short-term, intermediate-term, and chronic exposures. No evidence of risk to adults, infants, or children were found, and the EPA review stated ``There are no concerns for chronic dietary exposure.'' Similarly, the review states ``There are no concerns for any oral, dermal, or inhalation intermediate-term exosures to methoprene.'' The review concludes, ``Based on its review and evaluation of the available information, EPA concludes that there is a reasonable certainty that no harm will result to the general population, and to infants and children, from aggregate exposure to residues of methoprene.'' In

      [[Page 34827]]

      addition, EPA's risk assessment was based on conservative assumptions that assumed the existence of the tolerance exemption.

      Therefore, EPA is amending 40 CFR 180.1033 to exempt methoprene from the requirement of a tolerance by revising the commodities from ``raw agricultural'' to ``food'' and the use of control from ``mosquito'' to ``insect'' larvae. Because they are no longer needed, EPA is revoking all 35 tolerances for methoprene in 40 CFR 180.359, including: barley; buckwheat; cattle, fat; cattle, meat; cattle, meat byproducts; cereal grain milled fractions (except flour and rice hulls); corn (except popcorn and sweetcorn); egg; goat, fat; goat, meat; goat, meat byproducts; hog, fat; hog, meat; hog, meat byproducts; horse, fat; horse, meat; horse, meat byproducts; milk; millet; mushroom; oat; peanut; poultry, fat; poultry, meat; poultry, meat byproducts; rice; rice, hulls; rye; sheep, fat; sheep, meat; sheep, meat byproducts; sorghum (milo); and wheat in Sec. 180.359(a)(1), and feed supplement tolerances for beef cattle and dairy cattle in Sec. 180.359(a)(2).

      On July 9, 2002, EPA concluded that exemptions in 40 CFR 180.1132 watermelon mosaic virus-2 coat protein and zucchini yellow mosaic virus coat protein, and the genetic material necessary for the production of these proteins in or on summer squash were superseded by the exemption in 40 CFR 180.1184 in or on all food commodities. In addition, the Agency determined that these two exemptions were considered to be reassessed. Therefore, EPA is revoking the exemptions in 40 CFR 180.1132 because they are no longer needed. This final rule does not change availability or use of the pesticides mentioned. A copy of the July 9, 2002 memo is in the docket for this action.

   2. 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 if a numerical tolerance is being replaced by a tolerance exemption for those uses, or if the tolerance statement is redundant or has been superceded. EPA also proposes revocation of tolerances 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.

   3. When Do These Actions Become Effective?

      The actions in this final rule are effective on the date of its publication in the Federal Register. The only effect of the final rule will be to remove redundancies and inconsistencies in 40 CFR part 180. No person or entity is expected to be adversely affected. This final rule does not change the regulatory status of any registered products.

   4. What is the Contribution to Tolerance Reassessment?

      By law, EPA is required by August 2006 to reassess the tolerances in existence on August 2, 1996. As of May 7, 2003, EPA has reassessed over 6,500 tolerances. In this final rule, EPA is revoking 35 tolerances and 2 exemptions. These tolerances and exemptions were previously reassessed and counted as described in Unit II.A.

3. 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 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 has developed guidance concerning submissions for import tolerance support (65 FR 35069, June 1, 2000) (FRL-6559-3). This guidance will be made available to interested persons. Electronic copies are available on the Internet at http://www.epa.gov/. On the Home Page select ``Laws and Regulations,'' then select ``Regulations and Proposed Rules'' and then look up the entry for this document under ``Federal Register-- Environmental Documents.'' You can also go directly to the ``Federal Register'' listings at http://www.epa.gov/fedrgstr/.

4. 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. Although the procedures in those regulations require some modification to reflect the amendments made to the FFDCA by the FQPA, EPA will continue to use those procedures, with appropriate adjustments, until the necessary modifications can be made. The new section 408(g) of the FFDCA provides essentially the same process for persons to ``object'' to a regulation for an exemption from the requirement of a tolerance issued by EPA under new section 408(d) of FFDCA, as was provided in the old sections 408 and 409 of the FFDCA. However, the period for filing objections is now 60 days, rather than 30 days.

   1. 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-2003-0159 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 11, 2003.

      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

         [[Page 34828]]

         confidential may be disclosed publicly by EPA without prior notice.

         Mail your written request to: Office of the Hearing Clerk (1900C), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. You may also deliver your request to the Office of the Hearing Clerk in Rm.104, Crystal Mall 2, 1921 Jefferson Davis Hwy., Arlington, VA. 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 (703) 603-0061.

      2. Tolerance 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 at Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460- 0001.

         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 20460-0001.

      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.1. Mail your copies, identified by docket ID number OPP-2003-0159, 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- 0001. In person or by courier, bring a copy to the location of the PIRIB described in Unit I.B.1. 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 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.

   2. 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).

5. Statutory and Executive Order Reviews

   This final rule revokes tolerances established under section 408(d) of the FFDCA. 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 rule has been exempted from review under Executive Order 12866 due to its lack of significance, this 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 Low-Income 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, the pesticides mentioned in this rule have tolerance exemptions and will therefore remain available after this rule becomes effective. 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 section 408(n)(4) of the FFDCA. 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

   [[Page 34829]]

   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.

6. Congressional Review Act

   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 21, 2003. James Jones, Director, Office of Pesticide Programs.

   0 Therefore, 40 CFR chapter I is amended as follows:

   PART 180--[AMENDED]

   0 1. The authority citation for part 180 continues to read as follows:

   Authority: 21 U.S.C. 321(q), 346(a) and 371.

   Sec. 180.359 and 180.1132 [Removed]

   0 2. Sections 180.359 and 180.1132 are removed.

   0 3. Section 180.1033 is revised to read as follows:

   Sec. 180.1033 Methoprene; exemption from the requirement of a tolerance.

   Methoprene is exempt from the requirement of a tolerance in or on all food commodities when used to control insect larvae.

   [FR Doc. 03-14330 Filed 6-10-03; 8:45 am]

   BILLING CODE 6560-50-S