Chlorfenapyr; Pesticide Tolerance, 3649-3654 [05-1439]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 70, Number 16 (Wednesday, January 26, 2005)]
[Rules and Regulations]
[Pages 3649-3654]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-1439]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2004-0362; FRL-7696-5]


Chlorfenapyr; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for residues of 4-
bromo-2-(4-chlorophenyl)-1-(ethoxymethyl)-5-(trifluoromethyl)-1H-
pyrrole-3-carbonitrile in or on all foods except fruiting vegetables. 
BASF Corporation requested this tolerance under the Federal Food, Drug, 
and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act 
of 1996 (FQPA).

DATES: This regulation is effective January 26, 2005. Objections and 
requests for hearings must be received on or before March 28, 2005.

ADDRESSES: To submit a written objection or hearing request, follow the 
detailed instructions as provided in Unit VI. of the SUPPLEMENTARY 
INFORMATION. EPA has established a docket for this action under Docket 
identification (ID) number OPP-2004[dash]0362. All documents in the 
docket are listed in the EDOCKET index at https://www.epa.gov/edocket. 
Although listed in the index, some information is not publicly 
available, i.e., CBI or other information whose disclosure is 
restricted by statute. Certain other material, such as copyrighted 
material, is not placed on the Internet and will be publicly available 
only in hard copy form. Publicly available docket materials are 
available either electronically in EDOCKET, or in hard copy at the 
Public Information and Records Integrity Branch (PIRIB), Rm. 119, 
Crystal Mall 2, 1801 S. Bell St., 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.

FOR FURTHER INFORMATION CONTACT: Ann Sibold, Registration Division 
(7505C), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW.,Washington, D.C. 20460-0001; telephone 
number: 703 305-6502; e-mail address:sibold.ann@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 entities may include, but are not limited to:
     Food manufacturing (NAICS 311), e.g., agricultural 
workers; farmers; greenhouse, nursery, and floriculture workers; 
ranchers; pesticide applicators.
     Pesticide manufacturing (NAICS 32532), e.g., agricultural 
workers; commercial applicators; farmers; greenhouse, nursery, and 
floriculture workers; residential users.
    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 Access Electronic Copies of this Document and Other 
Related Information?

    In addition to using EDOCKET (https://www.epa.gov/edocket/), you may 
access this Federal Register document electronically through the EPA 
Internet under the ``Federal Register'' listings at https://www.epa.gov/
fedrgstr/. A frequently updated electronic version of 40 CFR part 180 
is available at E-CFR Beta Site Two at https://www.gpoaccess.gov/ecfr/. 
To access the OPPTS Harmonized Guidelines referenced in this document, 
go directly to the guidelines at https://www.epa.gpo/opptsfrs/home/
guidelin.htm/.

II. Background and Statutory Findings

    In the Federal Register of July16, 2003 (68 FR 42022) (FRL-7312-7), 
EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 
346a(d)(3), announcing the filing of a pesticide petition (PP 3F6560) 
by BASF Corporation, 26 Davis Drive, Research Triangle Park, North 
Carolina 27709. The petition requested that 40 CFR 180.513 be amended 
by establishing a tolerance for residues of the insecticide 4-bromo-2-
(4-chlorophenyl)-1-(ethoxymethyl)-5-(trifluoromethyl)-1H-pyrrole-3-
carbonitrile, chlorfenapyr, in or on all foods at 0.01 parts per 
million (ppm). That notice included a summary of the petition prepared 
by BASF Corporation, the registrant. Three public comments (OPP-2003-
0205-0001 (Green Party, MI), OPP-2003-0205-0002 (Fluoride Action 
Network), and

[[Page 3650]]

OPP-2003-0205-0003 (BASF Corporation)) were received in response to the 
registrant's petition. The substantive public comments and 
corresponding Agency responses are addressed in a separate document 
available in the docket for this action under Docket identification 
(ID) number OPP-2004-0362.
    The Green Party, MI took exception with the use of a tolerance to 
provide a `` safe'' level of pesticide residues in food. The Agency 
acknowledges this comment but notes that the Agency is authorized by 
section 408(b)(A)(i) of the Federal Food, Drug, and Cosmetic Act to 
establish tolerances. The Fluoride Action Network (FAN) provided a 
number of comments on the Agency's safety determination for 
chlorfenapyr including raising concerns about: (1) its role in ``Mad 
Cow Disease'' (transmissible spongiform encephalopathies), (2) 
aggregate exposure to chlorfenapyr and other fluorine and bromine 
containing pesticides and inerts, (3) aggregate exposure to 
chlorfenapyr and other neurotoxicants, (4) its role in 
neurodegenerative diseases and disease processes, (5) the status of a 
conditionally required developmental neurotoxicity study, and (6) 
public access to risk assessments and other supporting documentation. 
BASF, the chlorfenapyr registrant, provided a detailed response to the 
issues raised by FAN.
    The substantive public comments and corresponding Agency responses 
are addressed in a separate document available in the docket for this 
action under Docket identification (ID) number OPP-2004-0362. The 
Agency considered all of the substantive comments and saw no basis to 
support the claims that were made in the public comments. Again, the 
Agency's complete reasoning is discussed in the comment response 
document. As to FAN's comments regarding access to Agency documents on 
chlorfenapyr, EPA would note that there are extensive documents on 
chlorfenapyr on EPA's website. However, the Agency agrees with the 
comment that generally more access to information supporting this and 
other decisions is desirable, and in fact, the Registration Division, 
Office of Pesticide Programs is currently reviewing its procedures for 
docketing to address this concern.
    Section 408(b)(2)(A)(i) of 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 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 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 . . 
.``
    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 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).

III. Aggregate Risk Assessment and Determination of Safety

    Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the 
available scientific data and other relevant information in support of 
this action. EPA has sufficient data to assess the hazards of and to 
make a determination on aggregate exposure, consistent with section 
408(b)(2) of FFDCA, for a tolerance for residues of chlorfenapyr on all 
foods except fruiting vegetables at 0.01 ppm. EPA's assessment of 
exposures and risks associated with establishing the tolerance follows.

A. Toxicological Profile

    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. The nature of the toxic effects caused by chlorfenapyr as 
well as the no-observed-adverse-effect-level (NOAEL) and the lowest-
observed-adverse-effect-level (LOAEL) from the toxicity studies 
reviewed are discussed in the Federal Register of September 26, 2003 
(Vol. 68 No. 187 FR 55519-55527) (FRL-7320-8).

B. Toxicological Endpoints

    The dose at which no adverse effects are observed (the NOAEL) from 
the toxicology study identified as appropriate for use in risk 
assessment is used to estimate the toxicological level of concern 
(LOC). However, the lowest dose at which adverse effects of concern are 
identified (the LOAEL) is sometimes used for risk assessment if no 
NOAEL was achieved in the toxicology study selected. An uncertainty 
factor (UF) is applied to reflect uncertainties inherent in the 
extrapolation from laboratory animal data to humans and in the 
variations in sensitivity among members of the human population as well 
as other unknowns. An UF of 100 is routinely used, 10X to account for 
interspecies differences and 10X for intraspecies differences.
    Three other types of safety or uncertainty factors may be used: 
``Traditional uncertainty factors;'' the ``special FQPA safety 
factor;'' and the ``default FQPA safety factor.'' By the term 
``traditional uncertainty factor,'' EPA is referring to those 
additional uncertainty factors used prior to FQPA passage to account 
for database deficiencies. These traditional uncertainty factors have 
been incorporated by the FQPA into the additional safety factor for the 
protection of infants and children. The term ``special FQPA safety 
factor'' refers to those safety factors that are deemed necessary for 
the protection of infants and children primarily as a result of the 
FQPA. The ``default FQPA safety factor'' is the additional 10X safety 
factor that is mandated by the statute unless it is decided that there 
are reliable data to choose a different additional factor (potentially 
a traditional uncertainty factor or a special FQPA safety factor).
    For dietary risk assessment (other than cancer) the Agency uses the 
UF to calculate an acute or chronic reference dose (acute RfD or 
chronic RfD) where the RfD is equal to the NOAEL divided by an UF of 
100 to account for interspecies and intraspecies differences and any 
traditional uncertainty factors deemed appropriate (RfD = NOAEL/UF). 
Where a special FQPA safety factor or the default FQPA safety factor is 
used, this additional factor is applied to the RfD by dividing the RfD 
by such additional factor. The acute or chronic Population Adjusted 
Dose (aPAD or cPAD) is a modification of the RfD to accommodate this 
type of safety factor.
    For non-dietary risk assessments (other than cancer) the UF is used 
to determine the LOC. For example, when 100 is the appropriate UF (10X 
to account for interspecies differences and 10X for intraspecies 
differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to 
exposures (margin of

[[Page 3651]]

exposure (MOE) = NOAEL/exposure) is calculated and compared to the LOC.
    The linear default risk methodology (Q*) is the primary method 
currently used by the Agency to quantify carcinogenic risk. The Q* 
approach assumes that any amount of exposure will lead to some degree 
of cancer risk. A Q* is calculated and used to estimate risk which 
represents a probability of occurrence of additional cancer cases 
(e.g., risk). An example of how such a probability risk is expressed 
would be to describe the risk as one in one hundred thousand (1 X 
10-5), one in a million (1 X 
10-6), or one in ten million (1 X 
10-7). Under certain specific circumstances, MOE 
calculations will be used for the carcinogenic risk assessment. In this 
nonlinear approach, a ``point of departure'' is identified below which 
carcinogenic effects are not expected. The point of departure is 
typically a NOAEL based on an endpoint related to cancer effects though 
it may be a different value derived from the dose response curve. To 
estimate risk, a ratio of the point of departure to exposure 
(MOEcancer= point of departure/exposures) is calculated.
    A summary of the toxicological endpoints for chlorfenapyr used for 
human risk assessment is discussed in Unit III.B. of the final rule 
published in the Federal Register of September 26, 2003 (Vol. 68 No. 
187 FR 55519-55527) (FRL-7320-8).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. The tolerance 
established in 40 CFR 180.513 is further amended to set tolerances for 
residues of chlorfenapyr in or on all foods except fruiting vegetables 
at 0.01 ppm. Risk assessments were conducted by EPA to assess dietary 
exposures from chlorfenapyr in food as follows:
    i. Acute exposure. Acute dietary risk assessments are performed for 
a food-use pesticide if a toxicological study has indicated the 
possibility of an effect of concern occurring as a result of a one-day 
or single exposure.
    In conducting the acute dietary risk assessment EPA used the 
Dietary Exposure Evaluation Model software with the Food Commodity 
Intake Database (DEEM-FCIDTMVersion 2.03), which 
incorporates food consumption data as reported by respondents in the 
USDA 1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by 
Individuals (CSFII) and accumulated exposure to the chemical for each 
food item. The 1994-96, and 1998 data are based on the reported 
consumption of more than 20,000 individuals over two non-consecutive 
survey days. Foods ``as consumed'' (e.g., apple pie) are linked to EPA-
defined food commodities (e.g., apples, peeled fruit - cooked; fresh or 
baked; or wheat flour - cooked; fresh or baked) using publicly 
available recipe translation files developed jointly by USDA/
Argricultural Research Service (ARS) and EPA. Consumption data are 
retained as individual consumption events for acute exposure 
assessment. The following assumptions were made for the acute exposure 
assessments: Unrefined tier 1 acute dietary exposure assessments using 
tolerance-level residues and assuming 100% crop treated (CT) for all 
registered and proposed commodities, and default DEEMTM 
Version 7.76 processing factors for all commodities were conducted. The 
acute dietary exposure estimates are below EPA's level of concern 
(<100% aPAD) at the 95th exposure percentile for females 13-
49 years old (< 15% aPAD), and the general U.S. population (< 6% of the 
aPAD), and all other population subgroups. The most highly exposed 
population subgroup (other than females 13-49 years old) is children 1-
2 years old, at < 9% of the aPAD.
    ii. Chronic exposure. In conducting the chronic dietary risk 
assessment EPA used the DEEM-FCIDTM, which incorporates food 
consumption data as reported by respondents in the USDA 1994-1996 and 
1998 Nationwide Continuing Surveys of Food Intake by Individuals 
(CSFII), and accumulated exposure to the chemical for each food item. 
The 1994-96 and 1998 data are based on the reported consumption of more 
than 20,000 individuals over two non-consecutive survey days. Foods 
``as consumed'' (e.g., apple pie) are linked to EPA-defined food 
commodities (e.g., apples, peeled fruit - cooked; fresh or baked; or 
wheat flour - cooked; fresh or baked) using publicly available recipe 
translation files developed jointly by USDA/ARS and EPA. Consumption 
data are averaged for the entire U.S. population and within population 
subgroups for chronic exposure assessment. The following assumptions 
were made for the chronic exposure assessments: unrefined, Tier 1 
chronic dietary exposure using tolerance-level residues, assuming 100% 
CT for all registered and proposed commodities. The Agency concluded 
that the chronic dietary exposure estimates are below HED's level of 
concern (<100% cPAD for the general U.S. population (< 23% of the cPAD) 
and all population subgroups. The most highly exposed population 
subgroup is children 1-2 years old, at < 45% of the cPAD.
    2. Dietary exposure from drinking water. There is no concern for 
exposure to residues of chlorfenapyr in drinking water based on the 
approved, pending and proposed directions for use and chlorfenapyr's 
physical and chemical properties. Approved uses in the United States 
include applications to ornamental plants inside greenhouses, to a 
narrow band of soil adjacent to buildings and as a crack-and-crevice 
and spot treatments inside non-food/feed structures. In food handling 
areas chlorfenapyr is also applied as a crack-and-crevice and spot 
treatment inside structures. Chlorfenapyr has extremely low water 
solubility (120 parts per billion at 25[deg] C) and is also immobile in 
soil and does not leach because it is strongly adsorbed to all common 
soil types.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets). Non-dietary exposure 
to chlorfenapyr is expected to be negligible based on assessments made 
by EPA for all currently approved uses: ornamentals grown in 
greenhouses, as a termiticide, and for indoor applications for general 
pest control. These assessments were based on the physicochemical 
characteristics of the compound, the intended use patterns, and 
available information concerning its environmental fate. The vapor 
pressure of chlorfenapyr is less than 1 x 10-7 mm of mercury 
(Hg). Therefore, the potential for non-occupational exposure by 
inhalation is insignificant. These assessments also apply to the use in 
food/feed handling areas as a crack-crevice and spot treatment.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    Unlike other pesticides for which EPA has followed a cumulative 
risk approach based on a common mechanism of toxicity, EPA has not made 
a common mechanism of toxicity finding as to chlorfenapyr and any other 
substances and chlorfenapyr does not appear to produce a toxic 
metabolite produced by other substances. EPA has also evaluated 
comments submitted that suggested there might be a common mechanism 
between chlorfenapyr and other named pesticides that cause brain 
effects. EPA concluded that the

[[Page 3652]]

evidence did not support a finding of common mechanism for chlorfenapyr 
and the named pesticides. For the purposes of this tolerance action, 
therefore, EPA has not assumed that chlorfenapyr has a common mechanism 
of toxicity with other substances. For information regarding EPA's 
efforts to determine which chemicals have a common mechanism of 
toxicity and to evaluate the cumulative effects of such chemicals, see 
the policy statements released by EPA's Office of Pesticide Programs 
concerning common mechanism determinations and procedures for 
cumulating effects from substances found to have a common mechanism on 
EPA's website at https://www.epa.gov/pesticides/cumulative/.

D. Safety Factor for Infants and Children

    1. In general. Section 408 of FFDCA provides that EPA shall apply 
an additional tenfold margin of safety for infants and children in the 
case of threshold effects to account for prenatal and postnatal 
toxicity and the completeness of the data base on toxicity and exposure 
unless EPA determines based on reliable data that a different margin of 
safety will be safe for infants and children. Margins of safety are 
incorporated into EPA risk assessments either directly through use of a 
MOE analysis or through using uncertainty (safety) factors in 
calculating a dose level that poses no appreciable risk to humans. In 
applying this provision, EPA either retains the default value of 10X 
when reliable data do not support the choice of a different factor, or, 
if reliable data are available, EPA uses a different additional safety 
factor value based on the use of traditional uncertainty factors and/or 
special FQPA safety factors, as appropriate.
    The Agency previously identified that a developmental neurotoxicity 
(DNT) study was required for chlorfenapyr, based on the presence of 
neuropathology (CNS lesions), and neurotoxic signs seen in adult rats 
(males) and mice (both sexes). Considering the effects seen and the 
doses at which those effects occurred, the Agency concluded that a 10X 
safety factor is required until the data are received and evaluated.
    2. Prenatal and postnatal sensitivity. There is no evidence 
(qualitative or quantitative) for increased susceptibility following in 
utero exposure in the developmental toxicity studies in rats and 
rabbits or prenatal/postnatal exposure in the 2-generation reproduction 
study in rats. In both the rat and rabbit developmental toxicity 
studies maternal toxicity included decreased body weight gain. No 
developmental toxicity was noted in rats up to the highest dose tested 
of 225 mg/kg/day. Developmental toxicity in rabbits (increased post 
implantation loss) occurred at a higher dose than maternal toxicity. In 
the 2-generation reproduction study in rats, parental and offspring 
toxicity included body weight decrements at similar doses. No 
reproductive effects were noted up to the highest dose tested.
    3. Conclusion. EPA evaluated the potential for increased 
susceptibility of infants and children from exposure to chlorfenapyr. 
EPA concluded that the toxicology data base was incomplete for FQPA 
purposes because a required DNT has not been submitted. The DNT was 
required due to the presence of neuropathology (central nervous system 
lesions) and neurotoxic signs seen in adult rats (males) and mice (both 
sexes). Other than lacking the DNT study, EPA identified no residual 
uncertainties for prenatal/postnatal toxicity. This decision is based 
on the following:
     There is no evidence (qualitative or quantitative) of 
increased susceptibility of rat or rabbit fetuses to in utero exposure 
in developmental toxicity studies. There is no evidence (qualitative or 
quantitative) of increased susceptibility of rat offspring in the 
multi-generation reproduction toxicity study.
     There are no concerns or residual uncertainties for 
prenatal and postnatal toxicity in the available developmental and 2-
generation reproduction toxicity studies.
     The conservative residue assumptions used in the dietary 
exposure risk assessments, and the completeness of the residue 
chemistry database.

E. Aggregate Risks and Determination of Safety

    There are no existing or proposed uses of chlorfenapyr which would 
result in contamination of drinking water or residential exposures. 
Therefore, an aggregate-exposure risk assessment was not performed.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Samples of composited meals from the subject study were analyzed 
for residues of chlorfenapyr using American Cyanamid GC/ECD (Gas 
Chromatograph/Electron Capture Detector) Method M 2398. This method has 
undergone a successful petition method validation (PMV). The reported 
limit of quantitation (LOQ) is 0.01 ppm. The submitted concurrent 
recovery data indicate that GC/ECD Method M 2398 is adequate for 
determining residues of chlorfenapyr per se in/on composited meal 
samples. The data requirement for multiresidue methods has been 
satisfied pending FDA review and acceptance of the multiresidue 
methods.
    An 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: residuemethods@epa.gov.

B. International Residue Limits

    There are no established Codex, Canadian, or Mexican maximum 
residue levels (MRLs) for chlorfenapyr on all foods except fruiting 
vegetables at 0.01 ppm; therefore, harmonization of MRLs and U.S. 
tolerances is not an issue at this time.

C. Conditions

    A tolerance has been previously established for Vegetables, 
fruiting. group 8, at 1.0 ppm. The establishment of additional residue 
level tolerances for chlorfenapyr on all food (as requested by the 
petitioner) must therefore, exclude Vegetables, fruiting, group 8. The 
registrant (BASF) was required to submit a revised Section F, excluding 
Vegetables, fruiting, group 8 commodity from the petition. The 
registrant (BASF) has met this condition. In addition, data are 
required as a condition of registration. These were previously 
discussed in Unit IV. C. of the final rule published in the Federal 
Register of September 26, 2003 (Vol. 68 No. 187 FR 55519-55527) (FRL-
7320-8).

V. Conclusion

    Therefore, the tolerance is established for residues of 4-bromo-2-
(4-chlorophenyl)-1-(ethoxymethyl)-5-(trifluoromethyl)-1H-pyrrole-3-
carbonitrile, chlorfenapyr, in or on all foods except Vegetables, 
fruiting group 8 at 0.01 ppm.

VI. Objections and Hearing Requests

    Under section 408(g) of FFDCA, as amended by 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 FFDCA by FQPA, EPA 
will continue to use

[[Page 3653]]

those procedures, with appropriate adjustments, until the necessary 
modifications can be made. The new section 408(g) of 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 FFDCA, as was provided in the old sections 
408 and 409 of 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-2004-0362 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 March 28, 
2005.
    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 (1900L), 
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 Suite 350, 1099 14th St., 
NW., Washington, DC 20005. 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) 564-6255.
    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-
0001.
    If you would like to request a waiver of the tolerance objection 
fees, you must mail your request for such a waiver to: 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 VI. A., you 
should also send a copy of your request to the PIRIB for its inclusion 
in the official record that is described in ADDRESSES. Mail your 
copies, identified by docket ID number OPP-2004-0362, 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 ADDRESSES. 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).

VII. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under section 408(d) of 
FFDCA in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993). Because this rule has been 
exempted from review under Executive Order 12866 due to its lack of 
significance, this rule is not subject to Executive Order 13211, 
Actions Concerning Regulations That Significantly Affect Energy Supply, 
Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does 
not contain any information collections subject to OMB approval under 
the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose 
any enforceable duty or contain any unfunded mandate as described under 
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 
104-4). Nor does it require any special considerations under Executive 
Order 12898, entitled Federal Actions to Address Environmental Justice 
in Minority Populations and Low-Income Populations (59 FR 7629, 
February 16, 1994); or OMB review or any Agency action under Executive 
Order 13045, entitled Protection of Children from Environmental Health 
Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does 
not involve any technical standards that would require Agency 
consideration of voluntary consensus standards pursuant to section 
12(d) of the National Technology Transfer and Advancement Act of 1995 
(NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since 
tolerances and exemptions that are established on the basis of a 
petition under section 408(d) of 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

[[Page 3654]]

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 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.

VIII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801et 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 theFederal 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: December 24, 2004.
Betty Shackleford,
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), 346a and 371.

0
2. Section 180.513 is amended in paragraph (a) by designating the text 
following the paragraph heading General as paragraph (a)(1), and by 
adding paragraph (a)(2) to read as follows:


Sec.  180.513  Chlorfenapyr; tolerances for residues.

    (a) General. (1) * * *
    (2) A tolerance of 0.01 parts per million is established for 
residues of chlorfenapyr in or on all food commodities (other than 
those covered by a higher tolerance as a result of use on growing 
crops) in food/feed handling areas where food/feed products are 
prepared, held, processed, or served and in accordance with the 
following prescribed conditions:
    (i) Application shall be no greater than a 0.5% active ingredient 
solution for spot crack and crevice use in food/feed handling 
establishments, where food and food products are held, processed, 
prepared and/or served.
    (ii) Application may only be undertaken when the facility is not in 
operation, and provided exposed food has been covered, or removed from 
the area being treated prior to application.
    (iii) Food contact surfaces and equipment should be throughly 
washed with an effective cleaning compound, and rinsed with potable 
water after each use of the product.
    (iv) Contamination of food or food contact surfaces shall be 
avoided. Application excludes any direct application to any food, food 
packaging, or any food contact surfaces.
    (v) To assure safe use, the label and labeling shall conform to 
that registered by the U.S. Environmental Protection Agency, and it 
shall be used in accordance with such label and labeling.
* * * * *

[FR Doc. 05-1439 Filed 1-25-05; 8:45 am]
BILLING CODE 6560-50-S