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1-Methylcyclopropene (1-MCP) - Tolerance Requirement Exemption 7/02

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:
Benmhend.driss@epa.gov.

SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
    You may be affected by this action if you are an agricultural
producer, food manufacturer, or pesticide manufacturer. Potentially
affected categories and entities may include, but are not limited to:
------------------------------------------------------------------------
                                                          Examples of
           Categories                 NAICS codes         potentially
                                                       affected entities
------------------------------------------------------------------------
Industry                          111                 Crop production
                                  112                 Animal production
                                  311                 Food manufacturing
                                  32532               Pesticide
                                                       manufacturing
------------------------------------------------------------------------
    This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in the table could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether or not this action might apply to certain entities. If you have
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.
B. How Can I Get Additional Information, Including Copies of this
Document and Other Related Documents?
    1. Electronically. You may obtain electronic copies of this
document, and certain other related documents that might be available
electronically, from the EPA Internet Home Page at http://www.epa.gov/.
To access this document, on the Home Page select "Laws and
Regulations," "Regulations and Proposed Rules," and then look up the
entry for this document under the "Federal Register--Environmental
Documents." You can also go directly to the Federal Register listings
at http://www.epa.gov/fedrgstr/. 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,
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
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 178.25). If a hearing is requested, the objections
must include a statement of the factual issues(s) on which a hearing is
requested, the requestor's contentions on such issues, and a summary of
any evidence relied upon by the objector (40 CFR 178.27). Information
submitted in connection with an objection or hearing request may be claimed
confidential by marking any part or all of that information as CBI.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2. A copy of the information that
does not contain CBI must be submitted for inclusion in the public
record. Information not marked confidential may be disclosed publicly
by EPA without prior notice.
    Mail your written request to: Office of the Hearing Clerk (1900),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460. You may also deliver your request to the Office
of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St., SW.,
Washington, DC 20460. The Office of the Hearing Clerk is open from 8
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the Office of the Hearing Clerk is (202) 260-4865.
    2. Tolerance fee payment. If you file an objection or request a
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must
mail the fee to: EPA Headquarters Accounting Operations Branch, Office
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please
identify the fee submission by labeling it "Tolerance Petition Fees."
    EPA is authorized to waive any fee requirement "when in the
judgement of the Administrator such a waiver or refund is equitable and
not contrary to the purpose of this subsection." For additional
information regarding the waiver of these fees, you may contact James
Tompkins by phone at (703) 305-5697, by e-mail at tompkins.jim@epa.gov,
or by mailing a request for information to Mr. Tompkins at Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
    If you would like to request a waiver of the tolerance objection
fees, you must mail your request for such a waiver to: James Hollins,
Information Resources and Services Division (7502C), Office of
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460.
    3. Copies for the Docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit IX.A., you
should also send a copy of your request to the PIRIB for its inclusion
in the official record that is described in Unit I.B.2. Mail your
copies, identified by docket ID number OPP-2002-0142, 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: opp-docket@epa.gov. Please use an ASCII file
format and avoid the use of special characters and any form of
encryption. Copies of electronic objections and hearing requests will
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format.
Do not include any CBI in your electronic copy. You may also submit an
electronic copy of your request at many Federal Depository Libraries.
B. When Will the Agency Grant a Request for a Hearing?
    A request for a hearing will be granted if the Administrator
determines that the material submitted shows the following: There is a
genuine and substantial issue of fact; there is a reasonable
possibility that available evidence identified by the requestor would,
if established resolve one or more of such issues in favor of the
requestor, taking into account uncontested claims or facts to the
contrary; and resolution of the factual issues(s) in the manner sought
by the requestor would be adequate to justify the action requested (40
CFR 178.32).
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
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]