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thiophanate-methyl (Topsin M) Pesticide Tolerances for Emergency Exemptions 9/02



ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2002-0226; FRL-7196-5]

Thiophanate-methyl; Pesticide Tolerances for Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.

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SUMMARY: This regulation establishes time-limited tolerances for
residues of thiophanate-methyl and its metabolite (methyl 2-
benzimidazoyl carbamate (MBC)) in or on citrus and blueberry. This
action is in response to EPA's granting of emergency exemptions under
section 18 of the Federal Insecticide, Fungicide, and Rodenticide Act
authorizing use of the pesticide on citrus and blueberries. This
regulation establishes maximum permissible levels for residues of
thiophanate-methyl in these food commodities. The tolerances will
expire and are revoked on June 30, 2004.

DATES: This regulation is effective September 12, 2002. Objections and
requests for hearings, identified by docket ID number OPP-2002-0226,
must be received on or before November 12, 2002.

ADDRESSES: Written objections and hearing requests may be submitted by
mail, in person, or by courier. Please follow the detailed instructions
for each method as provided in Unit VII. of the SUPPLEMENTARY
INFORMATION. To ensure proper receipt by EPA, your objections and
hearing requests must identify docket ID number OPP-2002-0226 in the
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Andrea Conrath, Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460;
telephone number: 703-308-9356; e-mail address: conrath.andrea@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially 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, a beta site currently
under development.
    2. In person. The Agency has established an official record for
this action under docket ID number OPP-2002-0226. 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, 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

    EPA, on its own initiative, in accordance with sections 408(e) and
408 (l)(6) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21
U.S.C. 346a, is establishing tolerances for residues of the fungicide
thiophanate-methyl and its metabolite (methyl 2-benzimidazoyl carbamate
(MBC)), in or on citrus at 0.5 part per million (ppm), and blueberry at
1.5 ppm. These tolerances will expire and are revoked on June 30, 2004.
EPA will publish a document in the Federal Register to remove the
revoked tolerances from the Code of Federal Regulations.
    Section 408(l)(6) of the FFDCA requires EPA to establish a time-
limited tolerance or exemption from the requirement for a tolerance for
pesticide chemical residues in food that will result from the use of a
pesticide under an emergency exemption granted by EPA under section 18
of FIFRA. Such tolerances can be established without providing notice
or period for public comment. EPA does not intend for its actions on
section 18-related tolerances to set binding precedents for the
application of section 408 and the new safety standard to other
tolerances and exemptions. Section 408(e) of the FFDCA allows EPA to
establish a tolerance or an exemption from the requirement of a
tolerance on its own initiative, i.e., without having received any
petition from an outside party.
    Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish 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(b)(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. . . .''
    Section 18 of the Federal Insecticide, Fungicide, and Rodenticide
Act (FIFRA) authorizes EPA to exempt any Federal or State agency from
any provision of FIFRA, if EPA determines that ``emergency conditions
exist which require such exemption.'' This provision was not amended by
the Food Quality Protection Act (FQPA). EPA has established regulations
governing such emergency exemptions in 40 CFR part 166.

III. Emergency Exemptions for Thiophanate-methyl on Citrus and
Blueberries and FFDCA Tolerances

    Citrus. Post-bloom fruit drop (PFD) poses a significant economic
threat to the citrus industry throughout the humid, subtropical areas
of the U.S. (including Florida and Louisiana). Benomyl, which has
historically been used to manage PFD in citrus, was recently canceled
by the registrant, and available alternatives do not provide effective
control. Significant economic losses are expected without the requested
use of thiophanate-methyl. EPA has authorized under FIFRA section 18
the use of thiophanate-methyl on citrus for control of PFD fruit drop
disease in Florida and Louisiana. After having reviewed the
submissions, EPA concurs that emergency conditions exist for these
States.
    Blueberries. Benomyl has historically been used in blueberry
production to control several important fungal pathogens, including
Phomopsis Twig Blight and Canker (Phomopsis vaccinii), Fusicoccum
Canker (Fusicoccum putrefaciens), Botryosphaeria Blight (Monilinia
vaccinii-corymbosi), Anthracnose Fruit Rot (Colletotrichum acutatum),
Mummy Berry Disease (Botryosphaeria dothidea). The registrant's recent
cancellation of benomyl has left blueberry growers without sufficient
means to control these diseases, as available alternatives do not
provide adequate control. Significant economic losses are expected
without the requested use of thiophanate-methyl. EPA has authorized
under FIFRA section 18 the use of thiophanate-methyl on blueberries for
control of a variety of important blueberry diseases in Connecticut,
Indiana, Michigan, New Jersey, New York, Ohio, and Pennsylvania. After
having reviewed the submissions, EPA concurs that emergency conditions
exist for these States.
    As part of its assessment of this emergency exemption, EPA assessed
the potential risks presented by residues of thiophanate-methyl in or
on citrus and blueberry. In doing so, EPA considered the safety
standard in FFDCA section 408(b)(2), and EPA decided that the necessary
tolerances under FFDCA section 408(l)(6) would be consistent with the
safety standard and with FIFRA section 18. Consistent with the need to
move quickly on the emergency exemption in order to address an urgent
non-routine situation and to ensure that the resulting food is safe and
lawful, EPA is establishing these tolerances without notice and
opportunity for public comment as provided in section 408(l)(6).
Although these tolerances will expire and are revoked on June 30, 2004,
under FFDCA section 408(l)(5), residues of the pesticide not in excess
of the amounts specified in the tolerances remaining in or on citrus
and blueberry after that date will not be unlawful, provided the
pesticide is applied in a manner that was lawful under FIFRA, and the
residues do not exceed the level that was authorized by these
tolerances at the time of that application. EPA will take action to
revoke these tolerances earlier if any experience with, scientific data
on, or other relevant information on this pesticide indicate that the
residues are not safe.
    Because these tolerances are being approved under emergency
conditions, EPA has not made any decisions about whether thiophanate-
methyl meets EPA's registration requirements for use on citrus and
blueberry or whether permanent tolerances for these uses would be
appropriate. Under these circumstances, EPA does not believe that these
tolerances serve as a basis for registration of thiophanate-methyl by a
State for special local needs under FIFRA section 24(c). Nor do these
tolerances serve as the basis for any State other than those listed
above to use this pesticide on these crops under section 18 of FIFRA
without following all provisions of EPA's regulations implementing
section 18 as identified in 40 CFR part 166. For additional information
regarding the emergency exemption for thiophanate-methyl, contact the
Agency's Registration Division at the address provided under FOR
FURTHER INFORMATION CONTACT.

IV. Aggregate Risk Assessment and Determination of Safety

    EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 and a complete description of
the risk assessment process, see the final rule on Bifenthrin Pesticide
Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7).
    Consistent with section 408(b)(2)(D), EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of
thiophanate-methyl and to make a determination on aggregate exposure,
consistent with section 408(b)(2), for time-limited tolerances for
residues of thiophanate-methyl in or on citrus and blueberry at 0.5 and
1.5 ppm, respectively. The most recent estimated aggregate risks
resulting from the use of thiophanate-methyl, are discussed in the
Federal Register of August 28, 2002 (67 FR 55137) (FRL-7192-1), final
rule establishing tolerances for residues of thiophanate-methyl in/on
grape, pear, potatoe, canola, and pistachio, because in that prior
action, risk was estimated assuming tolerance level residues in all
commodities for established tolerances, as well as those being
proposed, such as the citrus and blueberry exemption uses. Refer to the
August 28, 2002 Federal Register document for a detailed discussion of
the aggregate risk assessments and determination of safety. EPA relies
upon that risk assessment and the findings made in the Federal Register
document in support of this action. Below is a brief summary of the
aggregate risk assessment.
    EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies 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. A summary of the toxicological dose and endpoints for
thiophanate-methyl for use in human risk assessment is discussed in
Unit III. of the final rule mentioned above, published in the Federal
Register of August 28, 2002 (67 FR 55137).
    For thiophanate-methyl, the Agency recently modified the tolerance
expression, so that the residues to be regulated in plant and animal
commodities for purposes of tolerance enforcement will consist of the
residues of thiophanate-methyl and its metabolite MBC, expressed as
thiophanate-methyl. Exposure from the use of benomyl, another pesticide
which degrades under environmental conditions to MBC was not included
in this assessment because the only basic registrant of benomyl
requested voluntary cancellation of all benomyl-containing products in
April 2001. Product cancellations were effective in early 2001 with
sales and distribution of benomyl containing products ending by
December 31, 2001. However, the Agency conducted a dietary assessment
using U.S. Department of Agriculture Pesticide Data Program (PDP)
monitoring data for benomyl, measured as MBC to estimate residues of
thiophanate-methyl because MBC is a common metabolite of both benomyl
and thiophanate-methyl. PDP data were available for apples, bananas,
beans, cucurbits, peaches, and strawberries. The PDP analytical method
employs a hydrolysis step that converts any benomyl present to MBC. MBC
is then quantitated and corrected for molecular weight, and results are
measured as the sum of benomyl and MBC. Therefore, using MBC data to
estimate thiophanate-methyl residues may be a conservative approach in
that it may overestimate thiophanate-methyl residues.
    EPA assessed risk scenarios for thiophanate-methyl under acute,
chronic, and short- and intermediate-term exposures.
    The Dietary Exposure Evaluation Model (DEEM)TM analysis
evaluated the individual food consumption as reported by respondents in
the USDA 1989-1992 nationwide Continuing Surveys of Food Intake by
Individuals (CSFII) and accumulated exposure to the chemical for each
commodity.
    For the acute exposure assessments, maximum percent crop treated
estimates and anticipated residue estimates were used. Using these
exposure assumptions, EPA concluded that acute dietary exposure to
thiophanate methyl uses 10% of the aPAD for the general U.S. population
and 25% of the acute Population Adjusted Dose (aPAD) for the most
highly exposed population subgroup of concern, infants, (less than 1
year). For MBC, the acute dietary risk estimate uses 4% of the aPAD for
the general U.S. population and 89% of the aPAD for the population
subgroup of concern, infants, (less than 1 year). The total
thiophanate-methyl plus MBC acute dietary risk estimate for the only
population subgroup of concern, females (13-50 years) uses 51% of the
aPAD. The drinking water assessment, based on simultaneous dietary
exposure to both MBC and thiophanate-methyl which was converted to MBC
equivalents resulted in the following Drinking Water Levels of Concern
(DWLOCs): Infants (less than 1 year) 18 ppb; children (1-6 years) 57
ppb; females (13-50 years) 150 - 170 ppb; and general U.S. population
5,700 ppb. The lowest DWLOC for the population subgroup, infants (less
than 1 year) does not exceed the Estimated Environmental Concentration
(EEC) for ground water (0.033 ppb); however, the DWLOC does exceed the
EEC for surface water (25 ppb). Although the EEC is exceeded, the DWLOC
is greatly inflated as 50% of the aPAD percentage is consumed by citrus
which is a limited emergency use only. When citrus is removed from the
DWLOC estimation, the DWLOC becomes 94 ppb which is well above the EEC
of 25 ppb. The DWLOC is significantly lowered by the addition of citrus
because field trial data was used which results in an overly
conservative estimation.
    Another indication that the addition of citrus based on field trial
data results in an over estimation is the fact that benomyl PDP data
available for citrus indicated that there were zero hits out of 689
Florida samples of orange juice. These data were not used to refine the
DWLOC estimation as the benomyl application rate is somewhat lower than
the rate approved for thiophanate methyl in this year's emergency
exemption. However, the Agency believes that most growers used the
previously registered benomyl rate, because the emergency exemption was
approved later in the use season and thus fewer applications than were
authorized were actually used. Furthermore, if the higher rate were
used, the impact would be lessened by the fact that juice is a blended
commodity. Therefore, although the DWLOC is exceeded, the acute dietary
risk from food and water does not exceed the Agency's level of concern.
    For the chronic exposure assessments, average residues from field
trial data and average percent crop treated estimates were used.
    Using these exposure assumptions, EPA has concluded that exposure
to thiophanate-methyl and MBC will utilize the following percentages of
the chronic Population Adjusted Dose (cPAD) for the U.S. population:
Thiophanate-methyl - 0.7%; MBC - 1.0% and total thiophanate-methyl plus
MBC - 1.7%. The major identifiable subgroup with the highest aggregate
exposure is children (1-6 years) and EPA has concluded that aggregate
dietary exposure to thiophanate-methyl and MBC will utilize the
following percentages of the cPAD: thiophanate-
methyl - 2.3%; MBC - 26% and total thiophanate-methyl plus MBC - 28%.
EPA generally has no concern for exposures below 100% of the cPAD
because the cPAD represents the level at or below which daily aggregate
dietary exposure over a lifetime will not pose appreciable risks to
human health. The aggregate chronic DWLOCs are as follows: 858 ppb for
the general U.S. population; 69 ppb for females (13-50 years); 22 ppb
for infants (less than 1 year); and 18 ppb for children (1-6 years).
The aggregate surface water EEC for thiophanate-methyl is 0.7 ppb; 14
ppb for MBC and 14.7 ppb for thiophanate-methyl plus MBC. Therefore,
the chronic aggregate risks do not exceed the Agency's level of
concern.
    Short-term aggregate exposure takes into account residential
exposure plus chronic exposure to food and water (considered to be a
background exposure level). Thiophanate-methyl and MBC are currently
registered for use that could result in short-term residential exposure
and the Agency has determined that it is appropriate to aggregate
chronic food and water and short-term exposures for thiophanate-methyl
and MBC.
    All residential exposures are considered to be short-term. The
Margins of Exposure (MOEs) (converted to MBC equivalents) for aggregate
short-term exposure to thiophanate-methyl are as follows: Oral exposure
of children (1-6 years) is 670; dermal exposure of children (1-6 years)
is 1,000; and dermal exposure of females (13-50 years) is 1,315. The
MOEs for aggregate exposure to MBC from the use of MBC as an in-can
preservative are 670 for dermal exposure and 770 for exposure via
inhalation. The MOEs (converted to MBC equivalents) for the total
thiophanate-methyl and MBC aggregate exposure are as follows: 630 for
oral and dermal exposure of children (1-6 years); 770 for exposure via
inhalation for females (13-50 years); and 620 for oral and dermal
exposure for females (13-50 years). Although the MOEs below 1,000
exceed the Agency's level of concern, when considering the conservative
method of exposure estimation previously discussed, and the negotiated
risk mitigation whereby the registrant has agreed to conduct hand-press
studies to help refine this assessment, the risks do not exceed the
Agency's level of concern.
    Aggregate cancer risk for U.S. population. The total thiophanate-
methyl and MBC dietary cancer risk is 8.5 x 10-7 for
existing and new uses. The cancer risk from non-occupational
residential exposure is 3.7 x 10-7. The aggregate cancer
risk is 1.2 x 10-6. This risk estimate includes cancer risk
from both thiophanate-methyl and MBC on food including all pending uses
and section 18 uses, thiophanate-methyl exposure from treating
ornamentals, thiophanate-methyl exposure from performing post-
application lawn activities, and exposure from applying paint
containing MBC. This is considered to be a high-end risk scenario since
it is not expected that someone would treat ornamentals, perform high
exposure post-application activities, and apply paint containing MBC
every year for 70 years. Therefore, this estimate is considered to be a
conservative estimate. Additionally, the cancer risk estimate based on
the highest EEC (thiophanate-methyl plus MBC EEC) is 9.6 x
10-7. This is also a very high-end risk estimate as it is
based on the maximum rate being applied every season for 70 years.
Thus, food plus water (assuming that the modeled surface water EEC is
equivalent to concentrations in finished drinking water) plus non-
occupational residential cancer risk is 2.2 x 10-6 which is
still within the range considered as negligible. In addition, the
cancer risk estimates using benomyl/MBC PDP monitoring data to estimate
thiophanate-methyl residues are below 1 x 10-6 for
thiophanate-methyl existing uses, new uses, and the amortized section
18 use on citrus and blueberry. Therefore, the risks do not exceed the
Agency's level of concern.
    Based on these risk assessments, EPA concludes that there is a
reasonable certainty that no harm will result to the general
population, and to infants and children from aggregate exposure to
thiophanate-methyl and MBC residues.

V. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology is available to enforce the
tolerance expression. The method may be requested from: Calvin Furlow,
PIRIB, IRSD (7502C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460;
telephone number: (703) 305-5229; e-mail address:
furlow.calvin@epa.gov.

B. International Residue Limits

    The Codex Alimentarius Commission has established maximum residue
limits (MRLs) for thiophanate-methyl residues in/on various plant and
animal commodities. Codex MRLs for thiophanate-methyl are currently
expressed as MBC. The Codex MRL residue definition and the U.S.
tolerance definition, previously expressed as only thiophanate-methyl,
have been incompatible and will remain incompatible even with the
recent revision of the U.S. tolerance definition, since the revised
tolerance definition includes both thiophanate-methyl and MBC.

C. Conditions

    A 30-day plant back interval is required for crops without labeled
uses of thiophanate-methyl.
    1. Citrus. Three to four applications (depending upon rate) may be
made at a rate of 1.05 to 1.4 pound of active ingredient per acre (lb
a.i./acre) using ground equipment. A maximum of 4.2 lb a.i./acre may be
applied per year.
    2. Blueberry. Up to three applications may be made at a rate of 0.7
lb a.i./acre. No more than three applications may be made, prior to the
harvest of the berries; do not exceed a total of 2.1 lb a.i./acre per
season.

VI. Conclusion

    Therefore, the tolerances are established for residues of
thiophanate-methyl and its metabolite, (methyl 2-benzimidazoyl
carbamate (MBC), expressed as thiophanate-methyl, in or on citrus at
0.5 ppm and blueberry at 1.5 ppm.

VII. 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-2002-0226 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 November 12, 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 VII.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 the docket ID number OPP-2002-0226, 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).

VIII. Regulatory Assessment Requirements

    This final rule establishes time-limited tolerances under FFDCA
section 408. 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 FIFRA
section 18 exemption under FFDCA section 408, such as the tolerances 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.

IX. 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: September 3, 2002.
Peter Caulkins,
Acting Director, Registration 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 374.

    2. Section 180.371 is amended by adding text and a table to
paragraph (b) to read as follows:

Sec.  180.371   Thiophanate-methyl; tolerances for residues.

* * * * *
    (b) Section 18 emergency exemptions. Time-limited tolerances are
established for the residues of thiophanate-methyl and its metabolite
(methyl 2-benzimidazoyl carbamate (MBC)) in connection with use of the
pesticide under section 18 emergency exemptions granted by EPA. The
tolerances are specified in the following table, and will expire and
are revoked on the dates specified.

------------------------------------------------------------------------
                                                             Expiration/
                    Commodity                     Parts per   revocation
                                                   million       date
------------------------------------------------------------------------
Blueberry.......................................        1.5     6/30/04
Citrus..........................................        0.5     6/30/04
------------------------------------------------------------------------

* * * * *

[FR Doc. 02-23266 Filed 9-11-02; 8:45 am]