[Federal Register Volume 67, Number 152 (Wednesday, August 7, 2002)]
[Rules and Regulations]
[Pages 51083-51088]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-19808]


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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.

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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: 
[email protected].

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_180/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)
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    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 [email protected], 
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: [email protected]. 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