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Methyl Anthranilate; Exemption from the Requirement of a Tolerance
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[Federal Register: August 7, 2002 (Volume 67, Number 152)] [Rules and Regulations] [Page 51083-51088] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr07au02-17] ======================================================================= ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [OPP-2002-0106; FRL-7189-7] Methyl Anthranilate; Exemption from the Requirement of a Tolerance AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. ----------------------------------------------------------------------- SUMMARY: This regulation establishes an exemption from the requirement of a tolerance for residues of methyl [[Page 51084]] anthranilate on all food commodities when applied/used in accordance with good agricultural practices. Bird Shield Repellent Corporation submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA), requesting an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of methyl anthranilate. DATES: This regulation is effective August 7, 2002. Objections and requests for hearings, identified by docket ID number OPP-2002-0106, must be received on or before October 7, 2002. ADDRESSES: Written objections and hearing requests may be submitted by mail, electronically, or in person. Please follow the detailed instructions for each method as provided in Unit X. of the SUPPLEMENTARY INFORMATION. To ensure proper receipt by EPA, your objections and hearing requests must identify docket ID number OPP- 2002-0106 in the subject line on the first page of your response. FOR FURTHER INFORMATION CONTACT: By mail: Jim Downing, c/o Product Manager (PM) 90, Biopesticides and Pollution Prevention Division (7511C), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: (703) 308-9071; e-mail address: Downing.Jim@epa.gov. SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? You may be affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected categories and entities may include, but are not limited to: ------------------------------------------------------------------------ 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. B. How Can I Get Additional Information, Including Copies of this Document and Other Related Documents? 1. Electronically. You may obtain electronic copies of this document, and certain other related documents that might be available electronically, from the EPA Internet Home Page 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 ``Federal Register--Environmental Documents.'' You can also go directly to the Federal Register listings at http://www.epa.gov/fedrgstr/. To access the OPPTS Harmonized Guidelines referenced in this document, go directly to the guidelines at http://www.epa.gov/opptsfrs/home/guidelin.htm. 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. 2. In person. The Agency has established an official record for this action under docket ID number OPP-2002-0106. The official record consists of the documents specifically referenced in this action, and other information related to this action, including any information claimed as Confidential Business Information (CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period is available for inspection in the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is (703) 305-5805. II. Background and Statutory Findings In the Federal Register of February 27, 2002 (67 FR 8968) (FRL- 6818-9), EPA issued a notice pursuant to section 408 of FFDCA, 21 U.S.C. 346a(d), as amended by FQPA (Public Law 104-170), announcing the filing of a pesticide tolerance petition (PP 1F6271) by Bird Shield Repellent Corporation, P.O. Box 785, Pullman, WA 99163. This notice included a summary of the petition prepared by the petitioner Bird Shield Repellent Corporation. There were no comments received in response to the notice of filing. The petition requested that 40 CFR 180.1143 be amended by establishing an exemption from the requirement of a tolerance for residues of methyl anthranilate in or on all food commodities. III. Risk Assessment New section 408(c)(2)(A)(i) of the FFDCA allows EPA to establish an exemption from the requirement for 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(c)(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....'' Additionally, section 408(b)(2)(D) requires that 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 performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. First, EPA determines the toxicity of pesticides. Second, EPA examines exposure to the pesticide through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings. IV. Toxicological Profile Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action and considered its validity, completeness, and reliability and the relationship of this information to human risk. EPA has also considered available information concerning the variability of the sensitivities of major [[Page 51085]] identifiable subgroups of consumers, including infants and children. Methyl anthranilate is naturally occurring in certain foods, such as concord grapes. It is also synthetically produced and used as a flavoring agent (21 CFR 182.60) in beverages, ice cream, candy, baked goods, gelatins, puddings, and chewing gum. It is also exempt from the requirement of a tolerance in or on blueberries, cherries, grapes, corn and sunflowers (40 CFR 180.1143). A discussion of the rationale supporting that exemption may be found in the first proposed rule ((60 FR 9816), February 22, 1995, (FRL-4936-2)), as well as in the final rules ((60 FR 20432), April 26, 1995, (FRL-4941-8)) and ((66 FR 30822), June 8, 2001, (FRL-6780-9)). In addition, methyl anthranilate is classified as generally recognized as safe (GRAS) by the Food and Drug Administration (FDA) (21 CFR 182.60). Methyl anthranilate, applied at labeled rates, rapidly decomposes into non-toxic components leaving no significant residues relative to levels found in food commodities to which it is applied, because of its volatility (MRID 42151903). Some residues studies found no residues at time of harvest, while other studies showed that the residues of methyl anthranilate were less than those found naturally in grapes. Moreover, it has been determined that even if ingested, the chemical rapidly metabolizes in the intestines and byproducts are excreted (MRID 44786300, Part B). In addition to this information, the Agency has determined that all toxicology data requirements have been satisfied and it has conducted a review of these studies. Summaries of these studies are presented below. For a more detailed discussion of these studies, see the Data Review Records located in the information docket referred to above. Methyl anthranilate exhibits little or no mammalian toxicity. It metabolizes in the intestine when consumed. The lethal dose (LD)50 values for methyl anthranilate were estimated to be greater than 5,000 milligram/kilogram (mg/kg) in an acute oral toxicity study in rats (Toxicity Category IV) and greater than 2,000 mg/kg in dermal toxicity studies using rats (Toxicity Category III). Whole body inhalation studies, for the same species, determined toxicity to be greater than 2.24 mg/L. Methyl anthranilate was found to cause moderate irritation in a rabbit skin irritation assay (Toxicity Category III) and corneal effects that cleared in 8 to 21 days in a rabbit eye irritation assay (Toxicity Category II). ------------------------------------------------------------------------- Guideline Study MRID No. Toxicity Category ------------------------------------------------------------------------- 870.1100 Acute Oral Toxicity - 44740301 IV rat 870.1200 Acute Dermal Toxicity 44740302 III 870.1300 Acute Inhalation 44740303 III Toxicity - rat 870.2400 Acute (Primary) Eye 44070302 II Irritation - rabbits 870.2500 Acute (Primary Dermal) 44070301 III Skin Irritation 870.2600 Hypersensitivity (skin NA Waived sensitization) -------------------------------------------------------------------------- Appropriate labeling (protective eyewear) was used to mitigate these minimal acute toxicological risks. Due to the low toxicity, metabolism, rapid degradation and long history of dietary exposure to this naturally occurring biochemical, chronic and subchronic data were waived. No other toxic endpoints were identified and therefore no reference dose and no observable adverse effect levels were established. V. Aggregate Exposures In examining aggregate exposure, FFDCA section 408 directs EPA to consider available information concerning exposures from the pesticide residue in food and all other non-occupational exposures, including drinking water from ground water or surface water and exposure through pesticide use in gardens, lawns, or buildings (residential and other indoor uses). A. Dietary Exposure 1. Food. Methyl anthranilate bird repellent is labeled to be applied at a rate of 0.2862 up to 6.18 pounds per acre depending on the crop/use. Pre-harvest intervals are established for all food crops on the label to minimize residues. Because of these relatively low use rates and pre-harvest intervals as currently registered and labeled, and the biochemical's rapid degradation, few methyl anthranilate residues have been detected on treated crops, and some studies found no residues immediately after application (MRID 45065102, 45065103, 45065104, 45065105). Further, because of its volatility and degradation (MRID 43119401) when exposed to ultraviolet light and elevated temperatures, no residues or low residues (below natural levels occurring in commonly consumed foods, such as grapes) are expected at harvest of treated crops (MRID 42740205). Dietary exposure to methyl anthranilate, by consumption of treated food or feed, is therefore expected to be negligible (MRID 44786301). Further, since methyl anthranilate has shown no mammalian toxicity and is rapidly metabolized in human intestines and liver, no dietary risk from any residues that may result from these additional uses of this biochemical pesticide are anticipated. To date, there have been no reports of any hypersensitivity incidents or reports of any known adverse reactions in humans resulting from exposure to methyl anthranilate. 2. Drinking water exposure. Methyl anthranilate is very unlikely to be found in drinking water, given the low application rates and rapid environmental and microbial degradation (MRID 431194-01). B. Other Non-dietary, Non-Occupational Exposure 1. Even though methyl anthranilate products are registered for use on lawns and ornamentals and are used on household garden crops (cherries, blueberries and table grapes), the non-occupational exposure is not expected to be great because of the limited number of times it will be used (once per season), the size of the crops to which the repellent will be applied, (backyard trees, bushes and vines), and the small amounts of the repellent required to protect the crops (for example, 0.0945 lbs./tree) from bird damage during a brief period of time (typically, 1 to 2 weeks). 2. Because the labeled application rate is low for residential uses and the fact that methyl anthranilate rapidly degrades under sunlight and elevated temperatures after application, only limited human exposure is anticipated. Household applicator exposure is addressed through appropriate labeling: ``Wear protective eyewear (goggles, face shield or safety glasses)'' and ``Do not get in eyes or on clothing.'' 3. Further, considering the fact that several uses of this biochemical have been registered for several years on several agricultural crops as well as turf, structures and ornamentals, the Agency has received no reports of adverse [[Page 51086]] effects from the uses of methyl anthranilate. VI. Cumulative Effects Methyl anthranilate does not exhibit a toxic mode of action to mammals, nor even to the target pest (birds), to which limit doses were tested. Thus, because there is no indication of mammalian toxicity to this biochemical, no cumulative effects with other compounds is expected. VII. Determination of Safety for U.S. Population, Infants and Children 1. U.S. population. There is a reasonable certainty that no harm will result from aggregate exposure to residues of methyl anthranilate to the U.S. population under reasonably foreseeable circumstances. This includes all anticipated dietary exposures and all other exposures for which there is reliable information. The Agency has arrived at this conclusion based on the very low levels of mammalian toxicity (no toxicity at the maximum doses tested) associated with methyl anthranilate and a history of safe use and consumption of methyl anthranilate as well as a consideration of the product as currently registered and labeled. 2. Infants and children. FFDCA section 408 provides that EPA shall apply an additional tenfold margin of exposure (safety) for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the data base unless EPA determines that a different margin of exposure (safety) will be safe for infants and children. Margins of exposure (safety) are often referred to as uncertainty (safety) factors. In this instance, based on all the available information, the Agency concludes that methyl anthranilate is practically non-toxic to mammals, including infants and children. Thus, there are no threshold effects of concern and, as a result the provision requiring an additional margin of safety does not apply. Further, the provisions of consumption patterns, special susceptibility, and cumulative effects do not apply. As a result, EPA has not used a margin of exposure (safety) approach to assess the safety of methyl anthranilate. VIII. Other Considerations A. Endocrine Disruptors EPA is required under the FFDCA, as amended by FQPA, to develop a screening program to determine whether certain substances (including all pesticide active and other ingredients) ``may have an effect in humans that is similar to an effect produced by a naturally- occurring estrogen, to other such endocrine effects as the Administrator may designate.'' Following the recommendations of its Endocrine Disruptor Screening and Testing Advisory Committee (EDSTAC), EPA determined that there was scientific basis for including, as part of the program, the androgen and thyroid hormone systems, in addition to the estrogen hormone system. EPA also adopted EDSTAC's recommendation that the program include evaluations of potential effects in wildlife. For pesticide chemicals, EPA will use FIFRA and, to the extent that effects in wildlife may help determine whether a substance may have an effect in humans, FFDCA authority to require the wildlife evaluations. As the science develops and resources allow, screening of additional hormone systems may be added to the Endocrine Disruptor Screening Programs (EDSP). When the appropriate screening and or testing protocols being considered under the Agency's EDSP have been developed, methyl anthranilate may be subjected to additional screening and/or testing to better characterize effects related to endocrine disruption. Based on available data, no endocrine system-related effects have been identified with the consumption of methyl anthranilate. It is a naturally occurring substance found in grapes. To date, there is no evidence to suggest that methyl anthranilate affects the immune system, functions in a manner similar to any known hormone, or that it acts as an endocrine disruptor. B. Analytical Method This action is establishing an exemption from the requirement of a tolerance for the reasons described above. As previously noted, methyl anthranilate exhibits rather low toxicity. For this reason and because no significant residues have been detected on treated crops at time of harvest (in other words, residues beyond that of methyl anthranilate found naturally in grapes are unlikely), no analytical method for enforcement purposes is necessary. C. Codex Maximum Residue Level The Agency is not aware of any international tolerances, exemptions from tolerance or Maximum Residue Levels (MRLs) issued for methyl anthranilate. Furthermore, the Agency is not aware of any issues regarding Codex MRLs. IX. Conclusions Based on the toxicology data submitted and other relevant information in the Agency's files, there is reasonable certainty no harm will result from aggregate exposure of residues of methyl anthranilate to the U.S. population, including infants and children, under reasonably foreseeable circumstances when the biopesticide product is used as labeled and in accordance with good agricultural practices. This includes all anticipated dietary exposures and all other exposures for which there is reliable information. The Agency has arrived at this conclusion based on data submitted demonstrating no toxicity at the maximum doses tested and a long history of safe use and consumption of naturally occurring methyl anthranilate as well as a consideration of the product as currently registered and labeled. As a result, EPA establishes an exemption from tolerance requirements pursuant to FFDCA 408(c) and (d) for residues of methyl anthranilate in or on all food commodities. X. 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. A. What Do I Need to Do to File an Objection or Request a Hearing? You must file your objection or request a hearing on this regulation in accordance with the instructions provided in this unit and in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number OPP-2002-0106 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 October 7, 2002. [[Page 51087]] 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 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 IX.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 ID number OPP-2002-0106, 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. B. When Will the Agency Grant a Request for a Hearing? A request for a hearing will be granted if the Administrator determines that the material submitted shows the following: There is a genuine and substantial issue of fact; there is a reasonable possibility that available evidence identified by the requestor would, if established resolve one or more of such issues in favor of the requestor, taking into account uncontested claims or facts to the contrary; and resolution of the factual issues(s) in the manner sought by the requestor would be adequate to justify the action requested (40 CFR 178.32). XI. Regulatory Assessment Requirements This final rule establishes an exemption from the requirement of 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 exemption 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 [[Page 51088]] 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. XII. Submission to Congress and the Comptroller General The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of this final rule in the Federal Register. This final rule is not a ``major rule'' as defined by 5 U.S.C. 804(2). List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: July 26, 2002 Janet L. Andersen, Director, Biopesticides and Pollution Prevention 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 371. 2. Section 180.1143 is revised to read as follows: Sec. 180.1143 Methyl anthranilate; exemption from the requirement of a tolerance. Residues of methyl anthranilate, a biochemical pesticide, are exempt from the requirement of a tolerance in or on all food commodities, when used in accordance with good agricultural practices. [FR Doc. 02-19808 Filed 8-6-02; 8:45 am] BILLING CODE 6560-50-S