[Federal Register Volume 67, Number 144 (Friday, July 26, 2002)]
[Rules and Regulations]
[Pages 48796-48800]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-18868]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2002-0142; FRL-7187-4]


1-Methylcyclopropene; 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 1-Methylcyclopropene (1-MCP) in or on 
fruits and vegetables when used as a post harvest plant growth 
regulator, i.e., for the purpose of inhibiting the effects of ethylene. 
AgroFresh, Inc. (formerly BioTechologies for Horticulture) 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 1-MCP.

DATES: This regulation is effective July 26, 2002. Objections and 
requests for hearings, identified by docket ID number OPP-2002-0142, 
must be received on or before September 24, 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 IX. of the 
SUPPLEMENTARY INFORMATION. To ensure proper receipt by EPA, your 
objections and hearing requests must identify docket ID number OPP-
2002-0142 in the subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Driss Benmhend, 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) 308-9525; 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/. 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.
    2. In person. The Agency has established an official record for 
this action under docket ID number OPP-2002-0142. 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 June 21, 2000 (65 FR 38550) (FRL-6589-
5), EPA issued a notice pursuant to section 408(d)(3) of the Federal 
Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d)(3), as amended 
by the Food Quality Protection Act (FQPA) (Public Law 104-170), 
announcing the filing of a pesticide tolerance petition (PP OF6144) by 
AgroFrech, Inc. (formerly BioTechnologies for Horticulture, Inc.), 100 
Independence Mall West, Philadelphia, PA 19106-2399. As required by 
section 408(d)(2)(A)(i)(I), this notice included a summary of the 
petition prepared by the petitioner AgroFresh, Inc. There were no 
comments received in response to the notice of filing.
    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,

[[Page 48797]]

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.

III. 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. The end-use product, a white powder, when mixed 
with water or a buffer solution releases the gas 1-MCP. The active 
ingredient acts an inhibitor to ethylene, by blocking the attachment of 
ethylene to tissue, and thus, prolongs the life of the food commodity 
treated.
    Toxicity studies submitted in support of the tolerance exemption 
petition, and the Agency reviews are compiled in the official record 
established for this action under the docket ID number OPP-2002-0142.
    1. Acute toxicity (MRIDs 444647-04 to 08). 1-MCP exhibits low acute 
toxicity. It is a category IV biopesticide. The rat oral 
LD50 is greater than 5,000 milligrams/kilograms (mg/kg), the 
rabbit dermal LD50 is greater than 2,000 mg/kg and the rat 
inhalation LC50 is greater than 2.5 milligram/liter (mg/L) 
(or greater than 1,126 parts per million (ppm) v/v active ingredient in 
air). No deaths or clinical signs of systemic toxicity were observed 
following these acute exposures. 1-MCP produces minimal irritation of 
skin and eyes in rabbits and 1-MCP is not a skin sensitizer. No 
hypersensitivity incidents were observed following exposure to 1-MCP.
    2. Genotoxicity (MRID 444647-09). 1-MCP was not mutagenic when 
tested as a gas in several short-term in vitro/in vivo assays, 
including a bacterial reverse mutation assay (Ames test), an in vitro 
mammalian point mutation assay in Chinese hamster ovary cells, an in 
vitro cytogenetics assay in human lymphocytes and an in vivo mouse 
micronucleus assay following inhalation exposure. In addition, 1-MCP is 
not mutagenic when tested as a suspension in cell media in the Ames 
test and in the in vitro mouse lymphoma forward mutation assay (MRID 
444647-10) and is not mutagenic in the in vivo mouse micronucleus assay 
(MRID 444747-11) following oral exposure (gavage).
    3. Developmental toxicity (MRID 454586-08). 1-MCP produces no 
developmental toxicity when tested in a standard developmental toxicity 
study in the rat via inhalation at concentrations up to and including 
2.3 mg a.i./L (or 543 mg a.i./kg/day, 6 hr exposure/day). The no 
observed adverse effect level (NOAEL) for maternal toxicity was 0.24 mg 
a.i./L (56 mg a.i./kg/day, 6 hr exposure/day).
    4. Subchronic toxicity (MRID 456090-01). 1-MCP was tested in a 90-
day inhalation study at doses of 0.05, 0.24 and 2.3 mg a.i./kg in the 
rat. The NOAEL is 0.05 mg a.i./L (equivalent to 9 to 15 mg a.i./kg/
day), based on minimal to mild effects on spleen and kidney 
histopathology at 0.24 mg a.i./L (equivalent to 39 to 66 mg a.i./kg/
day). In this study there was no evidence of neurotoxicity, no effects 
on the respiratory tract and no effects on pathology of any endocrine 
or reproductive organs up to and including the highest dose tested of 
2.3 mg a.i./L (or equivalent to 380 to 640 mg a.i./kg/day).
    5. AgroFresh (the applicant) submitted a waiver request for the 
immune response data requirements based on the current toxicological 
data submitted on 1-MCP. The review of the 3-month inhalation rat study 
(mentioned in the previous paragraph) indicates, no effects on thymus 
weight and no effects on the histopathology of the thymus, bone marrow 
or spleen that would be attributed to an impact on the immune system 
were seen. There were no effects on white blood cell differential 
parameters (including monocytes, lymphocytes, segmented neutrophils or 
eosinophils) and no basophils were observed which may be indicative of 
an allergic reaction. The Agency concluded that 1-MCP did not induce 
dysfunction or inappropriate suppressive responses in components of the 
immune system. As a result, immune response data requirements were 
waived.
    6. Other. 1-MCP has a mode of action in plants which is a non-
persistent and non-toxic mode of action. 1-MCP prevents the natural 
chemical, ethylene, from binding to ethylene receptors in plants. This 
mode of action is not relevant in animals, since ethylene receptors are 
not present in animal tissues.

IV. 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--From food and feed uses. The primary source for human 
exposure to 1-MCP will be from ingestion of the following raw food 
commodities and the processed food commodities derived from: apples, 
melons, tomatoes, pears, avocadoes, mangoes, papayas, kiwifruit, plums, 
apricots and persimmons. Studies submitted (MRID 456090-02) showed 
residues in treated apples to be extremely low (average residue was 
0.004 ppm using an exaggerated treatment rate of 1,200 parts per 
billion (ppb) versus the 1,000 ppb proposed label rate). A worst-case 
scenario (using the 0.004 ppm average residue concentration found in 
treated apples and assuming that concentration is present in 100% of 
the diet regardless of crops treated) indicates that a daily diet of 
1.5 kg/day could contain 0.006 mg 1-MCP. For the general population 
(assuming an average body weight of 60 kg), this would represent a 
daily intake of 0.0001 mg 1-MCP/kg body weight which is 90,000 to 
150,000-fold less than the 9-15 mg/kg NOAEL indicated in the 90-day 
inhalation study.
    Residues in other treated commodities are expected to be similar or 
even lower since the highest treatment rate is recommended for apples. 
Processing would be expected to further lower the residue levels in 
processed food commodities.
    2. Drinking water exposure. Since 1-MCP will only be used on post-
harvested fruits and vegetables in enclosed storage areas, there is 
little if any, potential for drinking water exposure.

B. Other Non-Occupational Exposure

    The potential for non-dietary exposure to 1-MCP for the general 
population, is unlikely because potential use sites are commercial, 
agricultural, and horticultural. 1-MCP is currently registered for 
indoor, nonfood commercial use on flowers and ornamentals. The Agency 
has approved that use, based on the data submitted that show little 
potential for significant non-occupational exposure to the general 
population.
    1. Dermal exposure. 1-MCP will only be sold enclosed in a generator 
for treatment of raw agricultural commodities. The generator will not 
release 1-MCP until the applicator has exited the storage area and 
entrances to the treatment area have been sealed. At

[[Page 48798]]

the end of the treatment period, the storage area will be vented before 
workers are permitted to reenter the area. This label mitigating 
language would eliminate the potential for dermal exposure to handlers 
or applicators.
    2. Inhalation exposure. As mentioned in the previous paragraph, the 
use of this product according to the label instructions would result in 
little, if any, inhalation exposure to handlers or applicators.

V. Cumulative Effects

    The Agency has considered the cumulative effects of 1-MCP and other 
substances in relation to a common mechanism of toxicity. These 
considerations include the possible cumulative effects of such residues 
on infants and children. There is no indication of mammalian toxicity 
at the maximum doses tested, of this or other products containing 1-
MCP.

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

    1. U.S. population. There is reasonable certainty that no harm will 
result from aggregate exposure to residues of 1-MCP to the U.S. 
population. 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, Toxicity Categories 
III and IV) and the minimum exposure associated with 1-MCP's use.
    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 1-MCP 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, based on the lack of observed developmental toxicity and 
extremely low exposure, there is reasonable certainty that no harm to 
infants, children, or adults will result from aggregate exposure to 1-
MCP residues. Exemption of 1-MCP from the requirements of a tolerance 
should pose no significant risk to humans or the environment

VII. 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, or 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 is no 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 wildlife evaluations. As the 
science develops and resources allow, screening of additional hormone 
systems may be added to the Endocrine Disruptor Screening 
Program(EDSP). When the appropriate screening and/or testing protocols 
being considered under the Agency's Endocrine Disruptor Screening 
Program have been developed, 1-MCP 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 consumption of 1-MCP. In addition, 1-MCP does not 
share any structural similarity to any known endocrine disruptive 
chemical.

B. Analytical Method(s)

    EPA is establishing an exemption from the requirement of a 
tolerance without any numerical limitation for the reasons stated 
above, including 1-MCP's lack of mammalian toxicity. For the same 
reasons, the Agency has concluded that an analytical method is not 
required for enforcement purposes for 1-MCP.

C. Codex Maximum Residue Level

    No Codex maximum residue levels are established for residues of 1-
MCP in or on any food or feed crop. There are no established tolerances 
or exemptions from tolerance for 1-MCP in the United States. The Agency 
has classified 1-MCP as a biochemical pesticide.

VIII. Conclusions

    Based on the toxicology data submitted, there is reasonable 
certainty no harm will result from aggregate exposure of residues of 1-
MCP to the U.S. population, including infants and children, when the 
proposed product is used in accordance with label instructions and good 
agricultural practices. This includes all anticipated dietary exposures 
and all other exposures for which reliable data were submitted, 
accepted and reviewed. The Agency has arrived at this conclusion based 
on the data submitted demonstrating no toxicity at the maximum doses 
tested. As a result, EPA establishes an exemption from tolerance 
requirements pursuant to FFDCA 408(c) and (d) for residues of 1-MCP in 
or on all food commodities.

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 ID number OPP-2002-0142 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 September 
24, 2002.
    1. Filing the request. Your objection must specify the specific 
provisions in the regulation that you object to, and the grounds for 
the objections (40 CFR

[[Page 48799]]

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-2002-0142, 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).

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). Because this rule has been exempted from review under Executive 
Order 12866 due to its lack of significance, this rule is not subject 
to Executive Order 13211, Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, 
May 22, 2001). This final rule does not contain any information 
collections subject to OMB approval under the Paperwork Reduction Act 
(PRA), 44 U.S.C. 3501 et seq., or impose any enforceable duty or 
contain any unfunded mandate as described under Title II of the 
Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor 
does it require any special considerations under Executive Order 12898, 
entitled Federal Actions to Address Environmental Justice in Minority 
Populations and Low-Income Populations (59 FR 7629, February 16, 1994); 
or OMB review or any Agency action under Executive Order 13045, 
entitled Protection of Children from Environmental Health Risks and 
Safety Risks (62 FR 19885, April 23, 1997). This action does not 
involve any technical standards that would require Agency consideration 
of voluntary consensus standards pursuant to section 12(d) of the 
National Technology Transfer and Advancement Act of 1995 (NTTAA), 
Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since 
tolerances and exemptions that are established on the basis of a 
petition under FFDCA section 408(d), such as the tolerance 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

[[Page 48800]]

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: July 16, 2002.
Marcia E. Mulkey,
Director, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

     Authority: 21 U.S.C. 321(q), 346(a) and 374.

    2. Section 180.1220 is added to subpart D to read as follows:


Sec. 180.1220  1-Methylcyclopropene; exemption from the requirement of 
a tolerance.

    An exemption from the requirement of a tolerance is established for 
residues of 1-Methylcyclopropene in or on fruits and vegetables when 
used as a post harvest plant growth regulator, i.e., for the purpose of 
inhibiting the effects of ethylene.
[FR Doc. 02-18868 Filed 7-25-02; 8:45am]
BILLING CODE 6560-50-S