[Federal Register Volume 66, Number 111 (Friday, June 8, 2001)]
[Rules and Regulations]
[Pages 30822-30826]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-14487]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-301127; FRL-6780-9]
RIN 2070-AB78


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 the methyl anthranilate on corn and 
sunflower when applied/used as a bird repellent. Bird Shield Repellent 
Corporation submitted a petition to EPA under the Federal Food, Drug, 
and Cosmetic Act, as amended by the Food Quality Protection Act of 
1996, 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 on corn and sunflower and reasses 
the existing tolerance exemption for methyl anthranilate.

DATES: This regulation is effective June 8, 2001. Objections and 
requests for hearings, identified by docket control number [OPP-
301127], must be received by EPA, on or before August 7, 2001.

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 IX. of the 
SUPPLEMENTARY INFORMATION. To ensure proper receipt by EPA, your 
objections and hearing requests must identify docket control number 
OPP-301127 in the subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Jim Downing, c/o Product 
Manager (PM) 91, Biopesticides and Pollution Prevention Division 
(7511C), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460; telephone number: 703-308-9071; and e-mail 
address: <a href="/cdn-cgi/l/email-protection#4c28233b2225222b622625210c293c2d622b233a"><span class="__cf_email__" data-cfemail="9efaf1e9f0f7f0f9b0f4f7f3defbeeffb0f9f1e8">[email protected]</span></a>.

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:

[[Page 30823]]



------------------------------------------------------------------------
                                                          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/. 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. 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-301127. 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 January 24, 2000 (65 FR 3693) (FRL-6485-
5), EPA issued a notice pursuant to section 408 of the Federal Food, 
Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), as amended by the 
Food Quality Protection Act (FQPA) (Public Law 104-170) announcing the 
filing of pesticide tolerance petitions (PP 9F5056 and 9F5055) by Bird 
Shield Repellent Corporation, P.O. Box 785, Pullman, WA 99163. This 
notice included a summary of the petitions 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 on corn and sunflower.

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 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, and grapes 
(40 CFR 180.1143). A discussion of the rationale supporting that 
exemption may be found in the proposed rule, as well as in the April 
26, 1995 final rule. In addition, methyl anthranilate is classified as 
generally recognized as safe (GRAS) by FDA (21 CFR 182.60).
    Methyl anthranilate, because of volatility, rapidly decomposes into 
non-toxic components leaving no significant residue relative to levels 
found in food on corn and sunflower to which it is applied. The residue 
studies showed that the residues of methyl anthranilate found on corn 
and sunflower 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. 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.
    Mammalian toxicity. Methyl anthranilate exhibits little or no 
mammalian toxicity. As mentioned before, it metabolizes in the 
intestine when consumed. The LD<INF>50</INF> values for methyl 
anthranilate were estimated to

[[Page 30824]]

be greater than 5,000 milligram/kilogram (mg/kg) in an acute oral 
toxicity study in rats (Toxicity Category IV). Methyl anthranilate was 
found to cause moderate irritation in a rabbit skin irritation assay 
after continuous exposure of the compound for 4 hours (Toxicity 
Category III) and corneal effects that cleared in 8 to 21 days in a 
rabbit eye irritation assay (Toxicity Category II). Since the mammalian 
toxicity is low and considering the diluted formulation that is used, 
no hypersensitivity studies were necessary.

----------------------------------------------------------------------------------------------------------------
              Guideline                         Study                   MRID No.            Toxicity Category
----------------------------------------------------------------------------------------------------------------
870.1100                               Acute Oral Toxicity -                  447403-01                       IV
                                        rat
----------------------------------------------------------------------------------------------------------------
870.1200                               Acute Dermal Toxicity                  447403-02                      III
----------------------------------------------------------------------------------------------------------------
870.1300                                Acute Inhalation                      447403-03                      III
                                        Toxicity - rat
----------------------------------------------------------------------------------------------------------------
870.2400                               Acute (Primary) Eye                    440703-02                       II
                                        Irritation - rabbits
----------------------------------------------------------------------------------------------------------------
870.2500                               Acute (Primary Dermal)                 440703-01                      III
                                        Skin Irritation
----------------------------------------------------------------------------------------------------------------
870.2600                               Hypersensitivity (skin                        NA                   Waived
                                        sensitization)
----------------------------------------------------------------------------------------------------------------

    Appropriate labeling (protective eyewear) was used to mitigate 
these moderately 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 effect level 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 residues, when used as a bird 
repellent, are already exempt from the requirement of a tolerance on 
blueberries, cherries and grapes, based upon a ``worst case'' maximum 
concentration on cherries of 35 ppm (60 FR 9816, February 22, 1995) and 
the fact that natural levels of 33 ppm occur in commonly consumed 
foods, such as grapes, and that use of methyl anthranilate as a 
flavoring agent results in residues of approximately 30 ppm in baked 
goods and up to 400 ppm in gum. For corn and sunflowers, methyl 
anthranilate, applied at a rate of only 0.2862 pounds per acre, results 
in residues of less than 33 ppm on these crops, even when taking into 
account the 4.5-fold and 14-fold maximum theoretical concentration 
factors for processed commodities. Because methyl anthranilate is a 
volatile compound, which rapidly degrades when exposed to ultraviolet 
light (sunlight), and warm temperatures in the environment, further 
reduction in residues is expected. The dietary exposure is not 
anticipated to be increased significantly in a typical human diet by 
the use of this biochemical pesticide on sunflowers and corn. Further, 
since methyl anthranilate has shown no mammalian toxicity and is 
rapidly metabolized in human intestines and liver, no dietary risk from 
these additional uses of this biochemical pesticide are anticipated.
    2. Drinking water exposure. Methyl anthranilate is very unlikely to 
be found in drinking water, given the extremely low application rate 
and rapid environmental and microbial degradation (MRID 431194-01).

B. Other Non-Dietary, Non-Occupational Exposure

    The primary non-dietary, non-occupational sources of exposure the 
Agency considered include exposure through use in lawns (turf), and on 
cherries, blueberries and grapes grown around the home or structures. 
Methyl anthranilate products are registered for use on residential turf 
(lawns) but not for any indoor uses. Limited exposure would result from 
use on home lawns, because of the rapid degradation of methyl 
anthranilate under sunlight. Even though methyl anthranilate products 
can be used on household (gardens) grown cherries, blueberries and 
grapes, the use is expected to be infrequent and very low, because of 
the limited quantities needed to control the targeted species during 
any growing season. In addition, methyl anthranilate rapidly degrades, 
thus limited exposure is anticipated. Use of methyl anthranilate around 
structures would not significantly increase the exposure, because of 
the limited use anticipated around the home. Home applicators could be 
exposed to methyl anthranilate, but this would be in a limited manner 
due to the infrequent use around the home. The Agency expects little 
risk from this exposure due to the low toxicity (LD<INF>50</INF> of 
>5,000 mg/kg oral toxicity in rats; dermal LD<INF>50</INF> of >2,000 
thru 5,000 mg/kg; inhalation LD<INF>50</INF> of >0.5 thru 2.0 mg/liter) 
of this natural constituent of certain plants (i.e., grapes).

VI. Cumulative Effects

    Methyl anthranilate does not exhibit a toxic mode of action to the 
target species (birds) or any mammals to which limit dose were tested. 
Thus, because there is no indication of mammalian toxicity to this 
substance, no cumulative effects with other related compounds is 
expected.

VII. Determination of Safety for U.S. Population, Infants and 
Children

    Methyl anthranilate has been demonstrated by the results of acute 
toxicity testing in mammals to cause no adverse effects when dosed 
orally and via inhalation at the limit dose of each study. Further, 
significant methyl anthranilate residues relative to levels found in 
foods have not been detected on treated corn and sunflower. Considering 
the low toxicity and the lack of significant residues of this naturally 
occurring biochemical, combined with its metabolism in the intestines 
if ingested, EPA has concluded that there is reasonable certainty that 
no harm will result from aggregate exposure to the U.S. population, or 
any significant subpopulation, including infants and children, to 
residues of methyl anthranilate. This includes all anticipated dietary 
exposures and all other exposures for which there is reliable 
information. EPA did not use a 10x safety factor for children in its

[[Page 30825]]

analysis because of the low toxicity of methyl anthranilate and the 
lack of significant residue relative to levels found in food when 
applied to corn and sunflower.

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 Endocrine Disruptor Screening Program 
have been developed, methyl anthranilate may be subjected to additional 
screening and/or testing to better characterize effects related to 
endocrine disruption. Based on the weight of the evidence of available 
data, no endocrine system-related effects have been identified.

B. Analytical Method(s)

    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 corn and 
sunflower (in other words, residues beyond that of methyl anthranilate 
found naturally in grapes are unlikely), no analytical method for 
enforcement purposes is required.

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 Maximum Residue Levels.

IX. 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 control number OPP-301127 in the subject line on the 
first page of your submission. All requests must be in writing, and 
must be mailed or delivered to the Hearing Clerk on or before August 7, 
2001.
    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 <a href="/cdn-cgi/l/email-protection#cdb9a2a0bda6a4a3bee3a7a4a08da8bdace3aaa2bb"><span class="__cf_email__" data-cfemail="c4b0aba9b4afadaab7eaaeada984a1b4a5eaa3abb2">[email protected]</span></a>, 
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 number OPP-301127, 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: <a href="/cdn-cgi/l/email-protection#620d12124f060d01090716220712034c050d14"><span class="__cf_email__" data-cfemail="d1bea1a1fcb5beb2bab4a591b4a1b0ffb6bea7">[email protected]</span></a>. Please use an ASCII file 
format and avoid the use of special characters and any form of 
encryption. Copies of

[[Page 30826]]

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).

X. Regulatory Assessment Requirements

    This final rule establishes an exemption from the tolerance 
requirement 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). 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 
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.

XI. 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: May 25, 2001.
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.

    Methyl anthranilate, a biochemical pesticide, is exempt from the 
requirement of a tolerance when used in accordance with good 
agricultural practices on the following raw agricultural commodities: 
Blueberry, cherry, corn, grape, and sunflower.

[FR Doc. 01-14487 Filed 6-7-01; 8:45 am]
BILLING CODE 6560-50-S


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