[Federal Register Volume 68, Number 24 (Wednesday, February 5, 2003)]
[Rules and Regulations]
[Pages 5847-5852]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-2770]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2002-0355; FRL-7285-9]


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 mushrooms. 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 mushroom spawn. 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, 2004.

DATES: This regulation is effective February 5, 2003. Objections and 
requests for hearings, identified by docket ID number OPP-2002-0355, 
must be received on or before April 7, 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)

[[Page 5848]]

    [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-2002-0355. 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 
(MBC)), in or on mushroom at 0.01 parts per million (ppm). This 
tolerance will expire and is revoked on December 31, 2004. 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 no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue. . . 
.''
    Section 18 of 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 Mushroom and FFDCA 
Tolerances

    Benomyl has historically been used in mushroom production to 
control fungal pathogens, including one of the most serious, green mold 
(Trichoderma aggresivum). The registrant's recent cancellation of 
benomyl has left mushroom growers in Delaware, Maryland, and 
Pennsylvania without sufficient means to control this disease, as there 
are no available alternatives. 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 mushroom spawn 
for control of green mold in Delaware, Maryland, and Pennsylvania. 
After having reviewed their 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 mushroom. 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, 
2004, 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 mushroom 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,

[[Page 5849]]

EPA has not made any decisions about whether thiophanate methyl meets 
EPA's registration requirements for use on mushroom 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 State other than Delaware, Maryland, and Pennsylvania 
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 exemptions 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 (62 FR 62961, November 26, 1997) (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 mushroom at 0.01 
ppm.
    The most recent estimated aggregate risks resulting from the use of 
thiophanate methyl, are discussed in the Federal Register for August 
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. Available residue data did not indicate that 
this use pattern will result in residues of thiophanate methyl in 
mushrooms over the limit of quantitation (LOQ), 0.01 ppm. Therefore, a 
tolerance is being established for mushroom at this level. Incremental 
addition of mushrooms at this level to dietary exposure, from existing 
food/feed uses, is negligible. Additionally, the results for this 
section 18 use do not alter the current aggregate exposure assessments 
with respect to drinking water or residential exposure. 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 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 (methyl 2-
benzimidazolyl carbamate (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 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 over 
estimate thiophanate methyl residues.
    EPA assessed risk scenarios for thiophanate methyl under acute, 
chronic, and short- and intermediate-term exposures.
    The Dietary Exposure Evaluation Model (DEEMTM) 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 acute Population 
Adjusted Dose (aPAD) for the general U.S. population and 25% of the 
aPAD for the most highly exposed population subgroup of concern, 
infants (< 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 (< 1 year). The total 
thiophanate methyl plus MBC acute dietary risk estimate for the 
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 (< 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 (< 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 because 50% of the aPAD percentage is consumed by 
citrus which is a 1-year 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 because the benomyl application rate is somewhat

[[Page 5850]]

lower than the rate approved for thiophanate methyl in this year's 
emergency exemption. However, the Agency believes that most growers 
used the 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 DWLOC's are as follows: 858 ppb for the general U.S. 
population; 69 ppb for females (13-50 years); 22 ppb for infants (< 1 
year); and 18 ppb for children (1-6 years). The aggregate surface water 
EECs 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 since 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-
0001; telephone number: (703) 305-5229; 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 1.0 ppm Codex MRL for thiophanate methyl on 
mushroom. The 0.01 ppm tolerance being established by this document 
will not harmonize with Codex.

C. Conditions

    The pesticide, thiophanate methyl, is to be mixed at 1.4 lbs. 
active ingredient (a.i.) (2 lbs. product) with 80 to 100 lbs. of 
gypsum, limestone, or chalk. This mixture will then be used to coat 
spawn grains (approximately 1,600 units) before mixing the spawn into 
the mushroom growing substrate. The substrate will then be applied to 
bed surface before spawning.

VI. Conclusion

    Therefore, the tolerance is established for residues of thiophanate 
methyl and its metabolite, (methyl 2-benzimidazoyl carbamate (MBC), 
expressed as thiophanate methyl, in or on mushroom at 0.01 ppm.

[[Page 5851]]

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-2002-0355 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 April 7, 
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 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-2002-0355, 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. Regulatory Assessment Requirements

    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

[[Page 5852]]

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 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: January 17, 2003.
Debra Edwards,
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 371.

    2. Section 180.371 is amended by alphabetically adding the entry 
for mushroom 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
------------------------------------------------------------------------
                              * * * * * * *
Mushroom..........................               0.01           12/31/04
------------------------------------------------------------------------

* * * * *
[FR Doc. 03-2770 Filed 2-4-03; 8:45 am]
BILLING CODE 6560-50-S