[Federal Register Volume 68, Number 141 (Wednesday, July 23, 2003)]
[Rules and Regulations]
[Pages 43465-43470]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-18499]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2003-0242; FRL-7317-5]


Thiophanate Methyl; Pesticide Tolerance for Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a time-limited tolerance for 
residues of thiophanate methyl and its metabolite methyl 2-
benzimidazoyl carbamate (MBC) in or on fruiting vegetables. This action 
is in response to EPA's granting of an emergency exemption under 
section 18 of the Federal Insecticide, Fungicide, and Rodenticide Act 
(FIFRA) authorizing use of the pesticide on fruiting vegetables. This 
regulation establishes a maximum permissible level for residues of 
thiophanate methyl in this food commodity. The tolerance will expire 
and is revoked on December 31, 2005.

DATES: This regulation is effective July 23, 2003. Objections and 
requests for hearings, identified by docket ID number OPP-2003-0242, 
must be received on or before September 22, 2003.

ADDRESSES: Written objections and hearing requests may be submitted 
electronically, by mail, or through hand delivery/courier. Follow the 
detailed instructions as provided in Unit VII. of the SUPPLEMENTARY 
INFORMATION.

FOR FURTHER INFORMATION CONTACT: Andrea Conrath, Registration Division 
(7505C), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 308-9356; e-mail address: [email protected].

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 entities may include, but are not limited to:
    [sbull] Crop producers (NAICS 111)
    [sbull] Animal producers (NAICS 112)
    [sbull] Food manufacturing (NAICS 311)
    [sbull] Pesticide manufacturing (NAICS 32532)
    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 this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. If you have any 
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 Copies of this Document and Other Related Information?

    1. Docket. EPA has established an official public docket for this 
action under docket identification ID number OPP-2003-0242. The 
official public docket consists of the documents specifically 
referenced in this action, any public comments received, and other 
information related to this action. Although a part of the official 
docket, the public docket does not include Confidential Business 
Information (CBI) or other information whose disclosure is restricted 
by statute. The official public docket is the collection of materials 
that is available for public viewing at the Public Information and 
Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall 2, 
1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open 
from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal 
holidays. The docket telephone number is (703) 305-5805.
    2. Electronic access. You may access this Federal Register document 
electronically through the EPA Internet under 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.
    An electronic version of the public docket is available through 
EPA's electronic public docket and comment system, EPA Dockets. You may 
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public 
comments, access the index listing of the contents of the official 
public docket, and to access those documents in the public docket that 
are available electronically. Although not all docket materials may be 
available electronically, you may still access any of the publicly 
available docket materials through the docket facility identified in 
Unit I.B.1. Once in the system, select ``search,'' then key in the 
appropriate docket ID number.

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 a tolerance for residues of the fungicide 
thiophanate methyl and its metabolite methyl 2-benzimidazoyl carbamate, 
in or on vegetables, fruiting, group 8 at 0.5 parts per million (ppm). 
This tolerance will expire and is revoked on December 31, 2005. EPA 
will publish a document in the Federal Register to remove the revoked 
tolerance 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 of the FFDCA 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) of the FFDCA 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) of the FFDCA 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

[[Page 43466]]

no harm will result to infants and children from aggregate exposure to 
the pesticide chemical residue. . . .''
    Section 18 of the 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 of 1996 
(FQPA). EPA has established regulations governing such emergency 
exemptions in 40 CFR part 166.

III. Emergency Exemptions for Thiophanate Methyl on Fruiting Vegetables 
and FFDCA Tolerances

    Benomyl has historically been used to control the disease caused by 
sclerotinia sclerotiorum, more commonly known as white mold, timber 
rot, or sclerotinia stem rot, in fruiting vegetables, including 
tomatoes. The recent cancellation of benomyl has left fruiting 
vegetable producers in Florida, and tomato producers in New Jersey and 
Virginia without sufficient means to control this disease, and the 
applicants claim that there are no other registered fungicides or 
alternative control practices which are effective to control this 
disease. Thiophanate methyl is related to benomyl, and degrades to the 
same active compound as benomyl. Field trial data also shows 
thiophanate methyl to be significantly effective at controlling white 
mold. It is expected that a similar level of control would be achieved 
with thiophanate methyl as that achieved in the past with benomyl. 
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 fruiting vegetables in Florida, and tomatoes 
only in New Jersey and Virginia, for control of white mold, also known 
as timber rot, or sclerotinia stem rot (sclerotinia sclerotiorum). 
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 fruiting vegetables. In doing so, EPA considered the safety standard 
in section 408(b)(2) of the FFDCA, and EPA decided that the necessary 
tolerance under section 408(l)(6) of the FFDCA 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 issuing this tolerance without notice and 
opportunity for public comment as provided in section 408(l)(6) of the 
FFDCA. Although this tolerance will expire and is revoked on December 
31, 2005, under section 408(l)(5) of the FFDCA, residues of the 
pesticide not in excess of the amounts specified in the tolerance 
remaining in or on fruiting vegetables 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 a level that was authorized 
by this tolerance at the time of that application. EPA will take action 
to revoke this tolerance earlier if any experience with, scientific 
data on, or other relevant information on this pesticide indicate that 
the residues are not safe.
    Because this tolerance is being approved under emergency 
conditions, EPA has not made any decisions about whether thiophanate 
methyl meets EPA's registration requirements for use on fruiting 
vegetables or whether a permanent tolerance for this use would be 
appropriate. Under these circumstances, EPA does not believe that this 
tolerance serves as a basis for registration of thiophanate methyl by a 
State for special local needs under FIFRA section 24(c). Nor does this 
tolerance serve as the basis for any States other than Florida, New 
Jersey, or Virginia to use this pesticide on this crop under section 18 
of FIFRA without following all provisions of EPA's regulations 
implementing FIFRA 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 of the FFDCA and a complete 
description of the risk assessment process, see the final rule on 
Bifenthrin Pesticide Tolerances November 26, 1997 (62 FR 62961) (FRL-
5754-7).
    Consistent with section 408(b)(2)(d) of the FFDCA , 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) of the FFDCA, for a time-
limited tolerance for residues of thiophanate methyl in or on fruiting 
vegetables at 0.5 ppm.
    The most recent estimated aggregate risks resulting from the use of 
thiophanate methyl, are discussed in the Federal Register ofAugust 28, 
2002 (67 FR 55137) (FRL-7192-1), final rule establishing tolerances for 
residues of thiophanate methyl in/on grapes, pears, potatoes, canola, 
and pistachios. In that prior action, risk was estimated assuming 
tolerance level residues in all commodities for established and 
proposed tolerances. Available residue data indicate that the use 
pattern for these emergency exemptions will not result in residues of 
thiophanate methyl in fruiting vegetables over 0.5 ppm. Therefore, a 
tolerance is being established for this crop group at this level. The 
risk assessment related to incremental addition of these items at this 
level to dietary exposure is discussed below. Refer also to the August 
28, 2002 Federal Register document for a detailed discussion of the 
aggregate risk assessments and determination of safety. EPA relies in 
part 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 the 
final rule published in the Federal Register of August 28, 2002 (67 FR 
55137) (FRL-7192-1). 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 
methyl 2-benzimidazolyl carbamate, 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

[[Page 43467]]

products ending by December 31, 2001. However, the Agency conducted a 
dietary assessment using United States Department of Agriculture (USDA) 
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.
    Monitoring data on benomyl from the PDP were used to estimate 
dietary exposure to MBC, for apples, apple juice, bananas, succulent 
beans, cantaloupes, cucumbers, peaches, strawberries, citrus, and 
fruiting vegetables.
    EPA assessed risk scenarios for thiophanate methyl under acute, 
chronic, and short-term and intermediate-term exposures. Risk estimates 
were calculated for the residues of toxicological concern, the parent 
compound thiophanate methyl, and its metabolites methyl 2-
benzimidazolyl carbamate plus 2-amine-1-H-benzimidazole (MBC+2-AB).
    To update the previous risk assessment, thiophanate-methyl acute 
and chronic dietary exposure assessments were conducted using the most 
current version of the Dietary Exposure Evaluation Model software with 
the Food Commodity Intake Database (DEEMTM-FCID), Version 
1.3), which incorporates consumption data from USDA's Continuing 
Surveys of Food Intakes by Individuals (CSFII), 1994-1996/98. The 1998 
CSFII survey focused on children from birth to 9 years old and greatly 
expanded (by several fold) the number of children aged birth to 4 
years. Importantly, the supplemental survey was designed in a manner 
such that the results from the 1998 CSFII survey could be combined with 
the 1994-96 survey. The data in this newer CSFII survey (termed the 
1994-1996/98 CSFII) are based on the reported consumption of more than 
20,000 individuals over two non-consecutive survey days and is 
considered to be a more appropriate and more robust data set than the 
1989-91 CSFII survey, which was used in the previous assessment.
    The most current version of DEEMTM-FCID was used for all 
dietary risk estimates calculated, and existing uses, as well as the 
proposed section 18 uses (blackberries, tomatoes and fruiting 
vegetables) were included. When calculating risk estimates from MBC+2-
AB, an FQPA safety factor of 10 was applied for all infant and children 
population subgroups. Percent of crop treated information was also 
incorporated for most established uses and for all of the section 18 
uses.
    The acute and chronic dietary risk estimates for thiophanate methyl 
were <100% of the acute and chronic Population Adjusted Doses (aPAD and 
cPAD) at the 99.9th exposure percentile for the general U.S. 
population and all population subgroups. The acute and chronic dietary 
risk estimates for MBC +2-AB were also <100% of the aPAD and cPAD at 
the 99.9th exposure percentile for the general U.S. 
population and all population subgroups. EPA generally has no concern 
for exposures below 100% of the PADs, because the PADs represent the 
level at or below which daily aggregate dietary exposure over a 
lifetime will not pose appreciable risks to human health. The most 
highly exposed subgroup for all risk estimates calculated was children 
1-2 years.
    Table 1 summarizes the percentages of aPADs and cPADs for all 
scenarios for the overall U.S. population and for the most highly 
exposed population subgroup (children 1-2 years).

                          Table 1.--Acute and Chronic Dietary Risk Estimates for Thiophanate Methyl Existing and Proposed Uses
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                                                                        aPAD Utilized                                     cPAD Utilized
                 Population Subgroup                 ---------------------------------------------------------------------------------------------------
                                                                 TM                   MBC +2-AB                    TM                   MBC +2-AB
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U.S. population                                                            6%                       2%                      <1%                      <1%
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Children (1-2 years)                                                      22%                      58%                       2%                      10%
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    The acute drinking water assessment, based on simultaneous dietary 
exposure to both MBC and thiophanate methyl (which was converted to MBC 
equivalents) resulted in Drinking Water Levels of Comparison (DWLOCs) 
for the overall U.S. population of 5,833 parts per billion (ppb), and 
for children (1-2 years) of 72 ppb (the population subgroup with the 
lowest DWLOC). All acute DWLOCs were well above the acute Estimated 
Environmental Concentrations (EECs) for ground water and surface water, 
at 3 and 44 ppb, respectively
    The chronic drinking water assessment, based on simultaneous 
dietary exposure to both MBC and thiophanate methyl (which was 
converted to MBC equivalents) resulted in chronic DWLOCs for the 
overall U.S. population of 870 ppb, and for children (1-2 years) of 22 
ppb (the population subgroup with the lowest DWLOC). All chronic DWLOCs 
were well above the chronic EEC for ground water of 3 ppb. The chronic 
DWLOCs were also above the chronic EEC for surface water of 23-24 ppb, 
except for that of the most highly exposed subgroup, children (1-2 
years), which is slightly below the EEC with a chronic DWLOC of 22 ppb. 
However, given the conservative nature of the screening-level approach 
to estimated drinking water risks, and the equivalent levels of the 
chronic DWLOC and EEC (22-23-24 ppb), the Agency does not believe this 
represents a significant risk or concern for chronic aggregate 
exposures.
    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 uses 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

[[Page 43468]]

dermal exposure of females (13-50 years) is 1,315. Prior to the 
application rate change agreed to by the registrants in connection with 
the Agency's reregistration process evaluation of thiophanate methyl, 
MOEs for aggregate exposure to MBC from the use of MBC as an in-can 
paint preservative were 670 for dermal exposure and 770 for exposure 
via inhalation. As a result of negotiated mitigation measures related 
to the reregistration review of this chemical, the registrant has now 
lowered the application rate for the in-can paint uses to the extent 
that the MOEs are now acceptable (>1,000). 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). The 
aggregate short-term exposure to MBC and thiophanate methyl resulting 
from food, water and residential use exceeds the Agency's level of 
concern for children (infants, and 1-6 years), and females 13-50 years, 
due primarily to post-application exposures on turf. Registrants are 
performing a hand press study and have submitted a 5-day inhalation 
study to help refine this assessment. Based on these mitigation 
measures, and the conservative method of exposure estimation, the risks 
do not exceed the Agency's level of concern.
    Aggregate cancer risk for U.S. population. The total thiophanate 
methyl and MBC+2-AB dietary cancer risk is 1.1 x 10-6 for 
existing and proposed new uses (incorporating the refinements and 
amortizations as previously described). The cancer risk from non-
occupational residential exposure is 1.1 x 10-6. Therefore, 
aggregate cancer risk is 2.2 x 10-6. This risk estimate 
includes cancer risk from both thiophanate methyl and MBC+2-AB 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 for 
drinking water is based on the highest EEC, which is also a very high-
end risk estimate since it is based on the maximum rate being applied 
every season for 70 years. The risk estimate calculations also assumed 
that the modeled surface water EEC is equivalent to concentrations in 
finished drinking water. Thus, food plus water plus non-occupational 
residential cancer risk is 2.2 x 10-6 which is within the 
range considered as negligible. 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+2-AB residues.

V. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology is available to enforce the 
tolerance expression. The method may be requested from: Chief, 
Analytical Chemistry Branch, Environmental Science Center, 701 Mapes 
Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; e-mail 
address:[email protected].

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. 
Additionally, there is a 5.0 ppm Codex MRL for thiophanate methyl on 
tomatoes. The 0.5 ppm tolerance for fruiting vegetables, including 
tomatoes, being established by this document will not harmonize with 
Codex.

C. Conditions

    The pesticide, thiophanate methyl may be applied using ground 
equipment, at a rate of 1 lb. of formulated product (0.7 lb. active 
ingredient (a.i.)) per acre, not to exceed 4 lbs. (2.8 lbs. a.i.) per 
acre per crop. A maximum of four applications per crop may be made at 7 
to 14 day intervals, and a 2-day pre-harvest interval must be observed. 
Applications may not be made through any type of irrigation system.

VI. Conclusion

    Therefore, the tolerance is established for residues of thiophanate 
methyl and its metabolite, MBC, expressed as thiophanate methyl, in or 
on vegetables, fruiting, group 8 at 0.5 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, EPA will continue to use those procedures, with 
appropriate adjustments, until the necessary modifications can be made. 
The new section 408(g) of the FFDCA 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) 
of the FFDCA, as was provided in the old sections 408 and 409 of the 
FFDCA. 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-2003-0242 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 
22, 2003.
    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

[[Page 43469]]

confidential may be disclosed publicly by EPA without prior notice.
    Mail your written request to: Office of the Hearing Clerk (1900C), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001. You may also deliver your request to the 
Office of the Hearing Clerk in Rm.104, Crystal Mall 2, 1921 
Jefferson Davis Hwy., Arlington, VA. 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 
(703) 603-0061.
    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-
0001.
    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 20460-0001.
    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.1. Mail your 
copies, identified by the docket ID number OPP-2003-0242, 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-
0001. In person or by courier, bring a copy to the location of the 
PIRIB described in Unit I.B.1. 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).

VIII. Statutory and Executive Order Reviews

    This final rule establishes a time-limited tolerance under section 
408 of the FFDCA. 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 section 408 of the FFDCA, such as the 
tolerance 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 section 408(n)(4) of the 
FFDCA. 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

[[Page 43470]]

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. Congressional Review Act

    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 10, 2003.
Deborah McCall,
Acting Director, Registration Division, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346(a) and 371.

0
2. Section 180.371 is amended by alphabetically adding the following 
commodity to the table in paragraph (b) to read as follows:


Sec.  180.371  Thiophanate methyl; tolerances for residues.

* * * * *
    (b) * * *

------------------------------------------------------------------------
                                                          Expiration/
             Commodity              Parts per million   revocation date
------------------------------------------------------------------------
                              * * * * * * *
Vegetable, fruiting, group 8......                0.5           12/31/05
------------------------------------------------------------------------

* * * * *
[FR Doc. 03-18499 Filed 7-22-03; 8:45 am]
BILLING CODE 6560-50-S