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

[Federal Register: January 23, 2002 (Volume 67, Number 15)]

[Rules and Regulations]

[Page 3113-3118]

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

[DOCID:fr23ja02-11]

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-301209; FRL-6818-7]

RIN 2070-AB78

Mepiquat; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes a tolerance for residues of mepiquat (N,N-dimethylpiperidinium) in or on cottonseed at 2.0 parts per million (ppm); cotton, gin byproducts at 6.0 ppm; and meat byproducts of cattle, goat, hog, horse and sheep at 0.1 ppm. BASF Corporation requested these tolerances under the Federal Food, Drug, and Cosmetic Act, as amended by the Food Quality Protection Act of 1996.

DATES: This regulation is effective January 23, 2002. Objections and requests for hearings, identified by docket control number OPP-301209, must be received by EPA on or before March 25, 2002.

ADDRESSES: Written objections and hearing requests may be submitted by mail, in person, or by courier. Please follow the detailed instructions for each method as provided in Unit VI. of the SUPPLEMENTARY INFORMATION. To ensure proper receipt by EPA, your objections and hearing requests must identify docket control number OPP-301209 in the subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Dennis McNeilly, Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,Washington, DC 20460; telephone number: (703) 308-6742; e-mail address: mcneilly.dennis@epa.gov.

SUPPLEMENTARY INFORMATION:

1. General Information

   1. Does this Action Apply to Me?

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

      Examples of Categories

      NAICS codes

      potentially affected entities

      Industry

      111

      Crop production 112

      Animal production 311

      Food manufacturing 32532

      Pesticide manufacturing

      This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in the table could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether or not this action might apply to certain entities. If you have questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT.

   2. 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 at http://www.epa.gov/. To access this document, on the Home Page select ``Laws and Regulations,'' ``Regulations and Proposed Rules,'' and then look up the entry for this document under the

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         ``Federal Register--Environmental Documents.'' You can also go directly to the Federal Register listings at http://www.epa.gov/fedrgstr/. A frequently updated electronic version of 40 CFR part 180 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr180_00.h tml, a beta site currently under development. To access the OPPTS Harmonized Guidelines referenced in this document, go directly to the guidelines at http://www.epa.gov/opptsfrs/home/guidelin.htm.

      2. In person. The Agency has established an official record for this action under docket control number OPP-301209. 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.

2. Background and Statutory Findings

   In the Federal Register of November 15, 2001 (66 FR 57446) (FRL- 6809-6), EPA issued a notice pursuant to section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a as amended by the Food Quality Protection Act of 1996 (FQPA) (Public Law 104-170) announcing the filing of a pesticide petition (PP) for tolerance by BASF Corporation, P.O. Box 13528, Research Triangle Park, NC 27709- 3528. This notice included a summary of the petition prepared by BASF Corporation, the registrant. There were no comments received in response to the notice of filing.

   The petition requested that 40 CFR 180.384 be amended by establishing a tolerance for residues of the plant growth regulator mepiquat, N,N-dimethylpiperidinium chloride and N,N- dimethylpiperidinium pentaborate, in or on cottonseed at 2.0 ppm; cotton, gin byproducts at 6.0 ppm; and meat byproducts of cattle, goat, hog, horse, and sheep at 0.1 ppm.

   The Agency is making the following minor changes to the tolerance action proposed in the petition:

   1. The title for the tolerance (Sec. 180.384) will be revised to mepiquat (N,N-dimethylpiperidinium) to reflect the fact that the tolerance covers both the ``chloride salt'' (mepiquat chloride) and ``pentaborate salt'' (mepiquat pentaborate) forms of mepiquat.

   2. Paragraph (a) is divided into two paragraphs with paragraph (a)(1) reflecting the ``generic '' tolerance for residues of either the ``chloride salt,'' or ``pentaborate salt,'' or both (e.g., cotton); while paragraph (a)(2) reflects those tolerances established only for the ``chloride salt '' form of mepiquat, i.e., mepiquat chloride. It is possible that in the future the Agency may propose combining these two paragraphs; however, mepiquat pentaborate is currently only proposed for registration on cotton. The only new commodity in this document for both mepiquat chloride and mepiquat pentaborate is cotton gin byproducts. The Mepiquat Chloride RED (March 1997) required residue data for this commodity, it has now been reviewed and the Agency has determined that a separate tolerance is required for this commodity. This resulted because of a revision to the Pesticide Assessment Guideline (Subdivision O, Residue Chemistry, 9/95) which recognized cotton gin byproducts as a raw agricultural commodity of cotton.

   Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is ``safe.'' Section 408(b)(2)(A)(ii) defines ``safe'' to mean that ``there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.'' This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to ``ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue....''

   EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. For further discussion of the regulatory requirements of section 408 and a complete description of the risk assessment process, see the final rule on Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7).

3. Aggregate Risk Assessment and Determination of Safety

   A human health risk assessment was previously conducted for mepiquat chloride foliar use on cotton and was published in the Mepiquat Chloride RED, March 1997. In fact, tolerances have been established for mepiquat chloride in/on cottonseed at 2.0 ppm and animal commodities at 0.1 ppm. In addition, the Agency recently published a risk assessment (65 FR 1790, January 12, 2000) (FRL-6485-4) for mepiquat chloride use on grapes and raisins which included the previously registered use on cotton. The January 12, 2000, risk assessment reflects the most current risk assessment available for mepiquat and will be referred to throughout this document. A revised risk and exposure analysis for use of mepiquat pentaborate, a ``pentaborate salt'' of mepiquat being registered for foliar use on cotton, was not conducted because exposure to mepiquat chloride from use on cotton was evaluated in the Agency's January 12, 2000, risk assessment. The registrant was required to submit a complete battery of acute toxicity studies, product chemistry data and a dissociation study to verify that mepiquat pentaborate application would be toxicologically equivalent to mepiquat chloride application and that the impurities would remain essentially equivalent or improved (more protective of human/ecological health) over current mepiquat chloride products. The company maintains, and the Agency has verified that both compounds, the ``chloride salt'' version mepiquat chloride and the ``pentaborate salt'' version mepiquat pentaborate, disassociate in water in the same manner and result in the same exposure, both qualitatively and quantitatively. Use rates and other label restrictions, related to food residue levels and tolerance issues, will be the same as for current mepiquat chloride products. Review of the product chemistry data confirmed that no new toxicologically significant impurities would be involved. Consistent with section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure, consistent with section 408(b)(2), for a tolerance for residues of mepiquat on cottonseed at 2.0 ppm; cotton, gin byproducts at 6.0 ppm; and meat

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   byproducts of cattle, goat, hog, horse, and sheep at 0.1 ppm. EPA's assessment of exposures and risks associated with establishing the tolerance follows.

   1. Toxicological Profile

      The Agency has determined that mepiquat pentaborate and mepiquat chloride are not significantly different as to impurities and/or toxicologically significant moieties. The registrant has submitted a battery of acute toxicity studies for mepiquat pentaborate which demonstrate that the acute toxicity is not significantly different from that of mepiquat chloride. The registrant has also submitted a dissociation study that demonstrates that mepiquat pentaborate dissociates in water in an identical physical manner to mepiquat chloride. It is the Agency's general policy that toxicology data for one ``salt'' support other mineral salts and that no additional toxicological data would be required for those entities. Mepiquat chloride is already registered for use on cotton and tolerances are established in 40 CFR 180.384 for residues of mepiquat chloride in/on cottonseed. In addition, tolerances for mepiquat chloride already exist for the fat, meat, and meat byproducts of cattle, goats, hogs, horses, and sheep (each at 0.1 ppm). The acute toxicity data for technical grade mepiquat pentaborate indicate toxicity category III for acute oral toxicity, acute dermal, acute inhalation, and primary eye irritation. The primary dermal irritation for mepiquat pentaborate is category IV, and mepiquat pentaborate is not a skin sensitizer.

   2. Toxicological Endpoints

      The Agency has determined that mepiquat pentaborate and mepiquat chloride are not significantly different as to impurities and/or toxicological significant moieties. Therefore, the toxicological endpoints published for mepiquat chloride on January 12, 2000 (65 FR 1790), pertain to this revision to 40 CFR 180.384. This revision to 40 CFR 180.384 simply adds tolerances for the pentaborate ``salt'' of mepiquat to the existing tolerances for the chloride ``salt'' version of mepiquat.

      The Acute Population Adjusted Dose (aPAD) is 0.6 milligrams/ kilograms/day (mg/kg/day) based on a 1-year dog feeding study with a 90-day dog feeding study supporting the 1-year dog study. The no observed adverse effect level (NOAEL) was 58.4 mg/kg/day with an Uncertainty Factor of 100 and the FQPA safety factor reduced to 1X. The Chronic Population Adjusted Dose (cPAD) is 0.6 mg/kg/day based on the 1-year dog feeding study with a supporting 90-day dog feeding study. The NOAEL was 58.4 mg/kg/day with an Uncertainty Factor of 100 and the FQPA safety factor reduced to 1X. Mepiquat chloride is classified as ``not likely'' to be a human carcinogen.

   3. Exposure Assessment

      1. Dietary exposure from food and feed uses. Tolerances have been established (40 CFR 180.384) for the residues of mepiquat, in or on a variety of raw agricultural commodities. Tolerances are established for cottonseed and for the fat, meat, and meat byproducts of cattle, goats, hogs, horses, and sheep at 0.1 ppm. A risk assessment was conducted by EPA and published for mepiquat chloride on January 12, 2000, that discusses use on cotton as well as all other registered uses of mepiquat chloride. Dietary exposure from the use of mepiquat pentaborate on cotton will be qualitatively and quantitatively the same as for the existing use of mepiquat chloride on cotton. The Agency has a disassociation study that confirms the qualitative equivalence and the same use rates and other restrictions will ensure equivalent quantitative exposure. The company expects that the pentaborate salt formulation of mepiquat, mepiquat pentaborate, will replace a significant amount of mepiquat chloride use on cotton.

         i. Acute exposure. The acute dietary food exposures (95\th\ percentile) occupy only 1.5% of the aPAD for the most highly exposed subgroup (children 1-6 years). This is based on a Tier 1 analysis, assuming tolerance level residues and 100% crop treated. Percent crop treated and/or anticipated residues were not used in the January 12, 2000, analysis.

         ii. Chronic exposure. The chronic dietary food exposures occupy only 0.3% of the cPAD for the most highly exposed subgroup (children 1- 6 years). This is based on a Tier 1 analysis, assuming tolerance level residues and 100% crop treated. Percent crop treated and/or anticipated residues were or were not used in the January 12, 2000, analysis.

         iii. Cancer. Mepiquat chloride was classified as ``not a likely human carcinogen.'' Therefore, a cancer risk assessment was not conducted for this risk analysis; nor, was one conducted for the January 12, 2000, risk analysis that discussed the use on cotton as well as all other mepiquat uses.

      2. Dietary exposure from drinking water. The Agency published a risk assessment for mepiquat chloride on January 12, 2000, that discusses use on cotton as well as all other registered uses of mepiquat chloride. In that analysis risk estimates for exposure to mepiquat chloride were below the Agency's level of concern. The Agency has reviewed a dissociation study for mepiquat pentaborate that demonstrates that mepiquat pentaborate dissociates in an identical physical manner to mepiquat chloride in water. Therefore, the analysis performed for mepiquat chloride or the ``chloride salt,'' also pertains to this mepiquat ``pentaborate salt'' use because the use rate, maximum seasonal use rate and other pertinent use factors remain the same as for mepiquat chloride or the ``chloride salt.''

      3. From non-dietary exposure. The term ``residential exposure'' is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). Mepiquat chloride and/or mepiquat pentaborate are not registered for use on any sites that would result in residential exposure.

      4. Cumulative exposure to substances with a common mechanism of toxicity. Section 408(b)(2)(D)(v) requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider ``available information'' concerning the cumulative effects of a particular pesticide's residues and ``other substances that have a common mechanism of toxicity.''

         EPA does not have, at this time, available data to determine whether mepiquat pentaborate and/or mepiquat chloride have a common mechanism of toxicity with other substances or how to include this pesticide in a cumulative risk assessment. Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, mepiquat does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has not assumed that mepiquat has a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the final rule for Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997).

   4. Safety Factor for Infants and Children

      In general. FFDCA section 408 provides that EPA shall apply an additional tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal

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      and postnatal toxicity and the completeness of the data base on toxicity and exposure unless EPA determines that a different margin of safety will be safe for infants and children. Margins of safety are incorporated into EPA risk assessments either directly through use of a margin of exposure (MOE) analysis or through using uncertainty (safety) factors in calculating a dose level that poses no appreciable risk to humans.

      The Agency has determined that the FQPA safety factor for mepiquat is 1X. See the Agency's risk assessment for mepiquat chloride dated January 12, 2000, for details. The facts are that mepiquat pentaborate is another ``salt'' of mepiquat and that mepiquat pentaborate disassociates to mepiquat and therefore the basic toxicology data base for mepiquat chloride pertains to mepiquat pentaborate.

   5. Aggregate Risks and Determination of Safety

      1. Acute risk. The Agency concludes that residues of mepiquat in food and drinking water will not exceed the Agency's level of concern (100% of the aPAD). For details see the Agency risk assessment published on January 12, 2000.

      2. Chronic risk. The Agency concludes that residues of mepiquat in food and drinking water will not exceed the Agency's level of concern (100% of the cPAD). For details see the Agency's risk assessment published on January 12, 2000.

      3. Short-term risk. Short-term aggregate exposure takes into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Mepiquat chloride and mepiquat pentaborate are not registered for use on any sites that would result in residential exposure. Therefore, the aggregate risk is the sum of the risk from food and water, which do not exceed the Agency's level of concern.

      4. Intermediate-term risk. Intermediate-term aggregate exposure takes into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Mepiquat chloride and mepiquat pentaborate are not registered for use on any sites that would result in residential exposure. Therefore, the aggregate risk is the sum of the risk from food and water, which does not exceed the Agency's level of concern.

      5. Aggregate cancer risk for U.S. population. Mepiquat chloride is classified as a ``not likely'' human carcinogen and thus not expected to pose a cancer risk to humans.

      6. Determination of safety. Based on these risk assessments, 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 mepiquat residues.

4. Other Considerations

   1. Analytical Enforcement Methodology

      Adequate enforcement methodology is available to enforce the tolerance expression. The method may be requested from: Calvin Furlow, PRRIB, IRSD (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: (703) 305-5229; e-mail address: furlow.calvin@epa.gov.

   2. International Residue Limits

      There are no CODEX, Canadian, or Mexican tolerances established for mepiquat on cotton. Thus, there are no international harmonization issues for these tolerances.

   3. Conditions

      The Agency is requiring as conditions for registration the following:

      1. Side-by-side residue field trials conducted with water as the diluent in all cotton growing areas of the United States (minimum of three).

      2. Developmental neurotoxicity study for mepiquat pentaborate.

5. Conclusion

   Therefore, the tolerance expression in 40 CFR 108.384(a)(1) is revised to reflect residues of mepiquat, in or on cottonseed; cotton gin by-products; and meat byproducts of cattle, goat, hog, horse, and sheep at 2.0, 6.0, and 0.1 ppm, respectively.

6. 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 of 1996, EPA will continue to use those procedures, with appropriate adjustments, until the necessary modifications can be made. The new section 408(g) 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), as was provided in the old FFDCA sections 408 and 409. 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 control number OPP-301209 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 25, 2002.

      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, DC 20460. You may also deliver your request to the Office of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St., SW., Washington, DC 20460. The Office of the Hearing Clerk is open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Office of the Hearing Clerk is (202) 260-4865.

      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

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         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.

         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.

      3. Copies for the Docket. In addition to filing an objection or hearing request with the Hearing Clerk as described in Unit VI.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-301209, to: Public Information and Records Integrity Branch, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. In person or by courier, bring a copy to the location of the PIRIB described in Unit I.B.2. You may also send an electronic copy of your request via e-mail to: 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).

7. Regulatory Assessment Requirements

   This final rule establishes a tolerance under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions 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 under 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 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). Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.) do not apply. In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure``meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.'' ``Policies that have federalism implications'' is defined in the Executive Order to include regulations that have ``substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.'' This final rule directly regulates growers, food processors, food handlers and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). For these same reasons, the Agency has determined that this rule does not have any ``tribal implications'' as described in Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure ``meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.'' ``Policies that have tribal implications'' is defined in the Executive Order to include regulations that have ``substantial direct effects on one or more Indian tribes, on the relationship between the Federal government and the Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes.'' This rule will not have substantial direct effects on tribal governments, on the relationship between the Federal government and Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule.

8. 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

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   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: January 4, 2002. Richard P. Keigwin, Jr., Acting Director, Registration Division, Office of Pesticide Programs.

   Therefore, 40 CFR chapter I 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), 346(a) and 374.

   2. Section 180.384 is revised to read as follows:

      Sec. 180.384 Mepiquat (N,N-dimethylpiperidinium); tolerances for residues.

      (a) General. (1) Tolerances are established for residues of the plant growth regulator mepiquat (N,N-dimethylpiperidinium) in or on the following commodities:

      Commodity

      Parts per million

      Cattle, mbyp

      0.1 Cotton, gin by-products

      6.0 Cottonseed

      2.0 Goats, mbyp

      0.1 Hogs, mbyp

      0.1 Horses, mbyp

      0.1 Sheep, mbyp

      0.1

      (2) Tolerances are established for residues of the plant growth regulator mepiquat chloride (N,N-dimethylpiperidinium chloride) in or on the following commodities:

      Commodity

      Parts per million

      Cattle, fat

      0.1 Cattle, meat

      0.1 Goat, fat

      0.1 Goat, meat

      0.1 Grapes

      1.0 Hogs, fat

      0.1 Hogs, meat

      0.1 Horses, fat

      0.1 Horses, meat

      0.1 Raisins

      5.0 Sheep, fat

      0.1 Sheep, meat

      0.1

      (b) Section 18 emergency exemptions. [Reserved]

      (c) Tolerances with regional registrations. [Reserved]

      (d) Indirect or inadvertent residues. [Reserved]

      [FR Doc. 02-1618Filed1-22-02; 8:45 am]

      BILLING CODE 6560-50-P