[Federal Register: September 19, 2007 (Volume 72, Number 181)]
[Rules and Regulations]
[Page 53436-53440]
[DOCID:fr19se07-11]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2007-0106; FRL-8147-8]

Pendimethalin; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for combined residues
of pendimethalin in or on artichoke, globe; asparagus; brassica head
and stem, subgroup 5-A; and grape. Interregional Research Project
Number 4 requested these tolerances under the Federal Food, Drug, and
Cosmetic Act (FFDCA).

DATES: This regulation is effective September 19, 2007. Objections and
requests for hearings must be received on or before November 19, 2007,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2007-0106. To access the
electronic docket, go to http://www.regulations.gov, select ``Advanced

Search,'' then ``Docket Search.'' Insert the docket ID number where
indicated and select the ``Submit'' button. Follow the instructions on
the regulations.gov website to view the docket index or access
available documents. All documents in the docket are listed in the
docket index available in regulations.gov. Although listed in the
index, some information is not publicly available, e.g., Confidential
Business Information (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 in the electronic docket at http://www.regulations.gov, or,

if only available in hard copy, at the OPP Regulatory Public Docket in
Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr.,
Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m.,
Monday through Friday, excluding legal holidays. The Docket Facility
telephone number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Susan Stanton, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
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 those
engaged in the following activities:
     Crop production (NAICS code 111), e.g., agricultural
workers; greenhouse, nursery, and floriculture workers; farmers.
     Animal production (NAICS code 112), e.g., cattle ranchers
and farmers, dairy cattle farmers, livestock farmers.
     Food manufacturing (NAICS code 311), e.g., agricultural
workers; farmers; greenhouse, nursery, and floriculture workers;
ranchers; pesticide applicators.
     Pesticide manufacturing (NAICS code 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 to
provide 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?

    In addition to accessing an electronic copy of this Federal
Register document through the electronic docket at http://www.regulations.gov
, you may access this Federal Register document

electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr. You may also access a

frequently updated electronic version of EPA's tolerance regulations at
40 CFR part 180 through the Government Printing Office's pilot e-CFR
site at http://www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, any person may file an objection to
any aspect of this regulation and may also request a hearing on those
objections. You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in 40 CFR part
178. To ensure proper receipt by EPA, you must identify docket ID
number EPA-HQ-OPP-2007-0106 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 as required by 40 CFR part 178 on or
before November 19, 2007.
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit this copy, identified by docket ID number
EPA-HQ-OPP-2007-0106, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.

Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket Facility telephone number is<PHONE_NUMBER>.

II. Petition for Tolerance

    In the Federal Register of April 4, 2007 (72 FR 16352-16356) (FRL-
8119-2), 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
6E7129) by Interregional Research Project Number 4 (IR-4), 500 College
Road East, Suite 201W, Princeton, NJ 08540. The petition requested that
40 CFR 180.361 be amended by establishing tolerances for combined
residues of the herbicide pendimethalin, N-(1-ethylpropyl)-3,4-
dimethyl-2,6-dinitrobenzenamine, and

its metabolite, 4-[(1-ethylpropyl)amino]-2-methyl-3,5-dinitrobenzyl
alcohol, in or on artichoke, globe at 0.05 parts per million (ppm);
asparagus at 0.1 ppm; brassica head and stem, subgroup 5A at 0.05; and
grape at 0.05 ppm. That notice referenced a summary of the petition
prepared by BASF Corporation, the registrant, which is available to the
public in the docket, http://www.regulations.gov. There were no

comments received in response to the notice of filing.
    Based upon review of the data supporting the petition, EPA has
revised the tolerances for artichoke, globe; asparagus; brassica, head
and stem vegetables, subgroup 5-A; and grape. The reason for these
changes is explained in Unit V.

III. Aggregate Risk Assessment and Determination of Safety

    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....'' These provisions were added to FFDCA by the Food Quality
Protection Act (FQPA) of 1996.
    Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for the petitioned-for tolerance
for combined residues of pendimethalin and its metabolite on artichoke,
globe at 0.1 ppm; asparagus at 0.15 ppm; brassica head and stem,
subgroup 5-A at 0.1; and grape at 0.1 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. Specific information on the studies received and the nature
of the adverse effects caused by pendimethalin, as well as the no-
observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-
effect-level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov
 in Appendix A of the document Pendimethalin. Human

Health Risk Assessment for the Proposed Food Uses of the Herbicide on
Artichoke, Globe; Asparagus; Brassica Head and Stem Vegetables,
Subgroup 5A; and Grape (PP#6E7129). The referenced document is
available in the docket established by this action, which is described
under ADDRESSES, and is identified as EPA-HQ-OPP-2007-0106-0003 in that
docket.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no
appreciable risk, the toxicological level of concern (LOC) is derived
from the highest dose at which no adverse effects are observed (the
NOAEL) in the toxicology study identified as appropriate for use in
risk assessment. However, if a NOAEL cannot be determined, the lowest
dose at which adverse effects of concern are identified (the LOAEL) is
sometimes used for risk assessment. Uncertainty/safety factors (UFs)
are used in conjunction with the LOC to take into account 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. Safety is assessed for acute and chronic
risks by comparing aggregate exposure to the pesticide to the acute
population adjusted dose (aPAD) and chronic population adjusted dose
(cPAD). The aPAD and cPAD are calculated by dividing the LOC by all
applicable UFs. Short-, intermediate-, and long-term risks are
evaluated by comparing aggregate exposure to the LOC to ensure that the
margin of exposure (MOE) called for by the product of all applicable
UFs is not exceeded.
    For non-threshold risks, the Agency assumes that any amount of
exposure will lead to some degree of risk and estimates risk in terms
of the probability of occurrence of additional adverse cases.
Generally, cancer risks are considered non-threshold. For more
information on the general principles EPA uses in risk characterization
and a complete description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm
.

    A summary of the toxicological endpoints for pendimethalin used for
human risk assessment can be found at http://www.regulations.gov in

document Pendimethalin. Human Health Risk Assessment for the Proposed
Food Uses of the Herbicide on Artichoke, Globe; Asparagus; Brassica
Head and Stem Vegetables, Subgroup 5A; and Grape (PP#6E7129) at pages
11-12. The referenced document is identified as EPA-HQ-OPP-2007-0106-
0003 in that docket.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to pendimethalin, EPA considered exposure under the
petitioned-for tolerances as well as all existing pendimethalin
tolerances in (40 CFR 180.361). EPA assessed dietary exposures from
pendimethalin in food as follows:
    i. Acute exposure. Quantitative acute dietary exposure and 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 1-day or single exposure. No such effects were
identified in the toxicological studies for pendimethalin; therefore, a
quantitative acute dietary exposure assessment is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the United States
Department of Agriculture (USDA) 1994-1996 and 1998 Nationwide
Continuing Surveys of Food Intake by Individuals (CSFII). As to residue
levels in food, EPA assumed all foods for which there are tolerances
were treated and contain tolerance-level residues.
    iii. Cancer. EPA has classified pendimethalin as a ``Group C''
(possible human) carcinogen, based on thyroid follicular cell adenomas
observed in rats. The chronic dietary risk assessment based on the
cPAD, however, is considered to be protective of any potential cancer
effects, because mode of action studies are available that demonstrate
that the thyroid tumors are due to a thyroid-pituitary imbalance, and
also since pendimethalin was shown to be nonmutagenic in

mammalian somatic cells and germ cells. Therefore, a separate cancer
exposure assessment was not conducted.
    iv. Anticipated residue and percent crop treated (PCT) information.
EPA did not use anticipated residue or PCT information in the dietary
assessment for pendimethalin. Tolerance level residues and 100 PCT were
assumed for all food commodities.
    2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring data to complete a comprehensive dietary exposure
analysis and risk assessment for pendimethalin in drinking water.
Because the Agency does not have comprehensive monitoring data,
drinking water concentration estimates are made by reliance on
simulation or modeling taking into account data on the environmental
fate characteristics of pendimethalin. Further information regarding
EPA drinking water models used in pesticide exposure assessment can be
found at http://www.epa.gov/oppefed1/models/water/index.htm.

    Based on the Pesticide Root Zone Model /Exposure Analysis Modeling
System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI-
GROW) models, the estimated environmental concentrations (EECs) of
pendimethalin for acute exposures are estimated to be 77.7 parts per
billion (ppb) for surface water and 0.036 ppb for ground water. The
EECs for chronic exposures are estimated to be 6.0 ppb for surface
water and 0.036 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. As explained in Unit III.C.1.,
an acute dietary risk assessment was not conducted for pendimethalin.
For the chronic dietary risk assessment, the water concentration of
value 6.0 ppb was used to access the contribution to drinking water.
    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).
    Pendimethalin is currently registered for the following residential
non-dietary sites: Recreational and residential turf (including home
lawns, golf courses, athletic fields, etc.) and ornamentals. EPA
assessed residential exposure based on applications to residential turf
(i.e., home lawns), since this use is expected to result in the
greatest residential exposure.
    There is a potential for short-term exposure of homeowners applying
products containing pendimethalin on home lawns. There is also a
potential for short-term post-application exposure of adults and
children entering lawn and recreation areas previously treated with
pendimethalin. Exposures from treated recreational sites are expected
to be similar to, or lower than, those from treated residential turf
sites; therefore, a separate exposure assessment for recreational turf
sites was not conducted. EPA assessed exposures from the following
residential turf post-application scenarios:
     Adult and toddler post-application dermal exposure from
contact with treated lawns.
     Toddlers' incidental ingestion of pesticide residues on
lawns from hand-to-mouth transfer.
     Toddlers' object-to-mouth transfer from mouthing of
pesticide-treated turfgrass.
     Toddlers' incidental ingestion of soil from pesticide-
treated residential areas.
The post-application risk assessment was conducted in accordance with
the Residential Standard Operating Procedures (SOPs) and recommended
approaches of the Health Effects Division's (HED's) Science Advisory
Council for Exposure (ExpoSAC).
    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 pendimethalin and any
other substances and pendimethalin does not appear to produce a toxic
metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has not assumed that pendimethalin 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 EPA's website at http://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 (``10X'') 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 database on toxicity and
exposure unless EPA determines based on reliable data that a different
margin of safety will be safe for infants and children. This additional
margin of safety is commonly referred to as the FQPA safety factor. 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 FQPA
safety factor value based on the use of traditional UFs and/or special
FQPA safety factors, as appropriate.
    2. Prenatal and postnatal sensitivity. The pre- and postnatal
toxicology database for pendimethalin includes rat and rabbit
developmental toxicity studies and a 2-generation reproduction toxicity
study in rats.
    In the rat developmental study, there were no maternal or
developmental effects noted at any dose level tested. However, the
study is considered adequate and a new study is not required because in
other rat studies, thyroid toxicity was seen at significantly lower
doses than the highest dose tested (500 milligrams/kilograms/day (mg/
kg/day)) in this study. If thyroid parameters had been measured,
maternal toxicity would likely have been demonstrated.
    The rabbit toxicity study with pendimethalin did not demonstrate
maternal or developmental toxicity at doses up to 60 mg/kg/day (highest
dose tested). Since neither maternal nor developmental toxicity was
seen at the highest dose tested, potential for increased sensitivity of
the offspring could not be determined.
    In the 2-generation reproduction study in rats, there was no
evidence of increased susceptibility of offspring. Effects in the pups
(decreased pup body weight gain and possible decreased pups born alive
and pup survival) were seen at doses that also resulted in parental
toxicity (decreased body weight).
    3. Conclusion. EPA has determined that the FQPA safety factor of
10X must be retained. This decision is based on the following findings:
    i. The toxicity database for pendimethalin contains all of the
standard toxicity studies. However, there is uncertainty regarding
potential thyroid effects seen in some of these

studies. Based on the hormonal changes (alterations in thyroid weights
and histopathological lesions) observed in several studies following
oral administration of pendimethalin, it is likely that pendimethalin
may cause disruption in the endocrine system. There is concern that
perturbation of thyroid homeostasis may lead to hypothyroidism and
possibly result in adverse effects on the developing nervous system.
Consequently, EPA has recommended that a developmental thyroid assay be
conducted to evaluate the impact of pendimethalin on thyroid hormones,
structure, and/or thyroid hormone homeostasis during development. This
study has not yet been submitted.
    ii. There is no indication that pendimethalin is a neurotoxic
chemical and there is no need for a developmental neurotoxicity study
or additional UFs to account for neurotoxicity.
    iii. There is no evidence that pendimethalin results in increased
susceptibility in in utero rats or rabbits in the prenatal
developmental studies or in young rats in the 2-generation reproduction
study. However, the developmental studies were not adequate to fully
assess the potential for susceptibility. Consequently, there is concern
for potential increased sensitivity or susceptibility in offspring
regarding thyroid effects.
    iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100 PCT and tolerance-level residues. Conservative ground and
surface water modeling estimates were used. Similarly, conservative
Residential SOPs were used to assess post-application exposure of
children as well as incidental oral exposure of toddlers. These
assessments will not underestimate the exposure and risks posed by
pendimethalin.
    Although the exposure estimate is very conservative and there are
no neurotoxic concerns for pendimethalin, there is sufficient
uncertainty regarding thyroid effects, particularly thyroid effects in
the young, that EPA is retaining the 10X FQPA safety factor. EPA has
also determined that the traditional 10X uncertainty factor to account
for interspecies variation may be reduced to 3X, since it has been
established that rats are more susceptible to thyroid effects than
humans. These factors, together with the traditional 10X uncertainty
factor to account for intraspecies variation, result in a total
uncertainty factor of 300X (10X, 3X, and 10X).

E. Aggregate Risks and Determination of Safety

    Safety is assessed for acute and chronic risks by comparing
aggregate exposure to the pesticide to the acute population adjusted
dose (aPAD) and chronic population adjusted dose (cPAD). The aPAD and
cPAD are calculated by dividing the LOC by all applicable UFs. For
linear cancer risks, EPA calculates the probability of additional
cancer cases given aggregate exposure. Short-, intermediate-, and long-
term risks are evaluated by comparing aggregate exposure to the LOC to
ensure that the margin of exposure (MOE) called for by the product of
all applicable UFs is not exceeded.
    1. Acute risk. None of the toxicology studies available for
pendimethalin has indicated the possibility of an effect of concern
occurring as a result of a 1-day or single exposure; therefore, a
quantitative acute dietary exposure assessment is unnecessary.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
pendimethalin from food and water will utilize 16% of the cPAD for
children, 1 to 2 years old, the population group with the greatest
estimated exposure. Based the use pattern, chronic residential exposure
to residues of pendimethalin is not expected.
    3. Short-term risk. Short-term aggregate exposure takes into
account residential exposure plus chronic exposure from food and water
(considered to be a background exposure level). Pendimethalin is
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 pendimethalin.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded that food, water and residential
exposures aggregated result in aggregate MOEs of 650 for adult males,
580 for adult females, and 390 to 410 for children, 1 to 2 years old
(depending on the application rate assessed). The aggregate MOEs for
adults are based on the residential turf scenario and include combined
food, drinking water and post-application dermal exposures. The
aggregate MOEs for children include food, drinking water, post-
application dermal and incidental oral exposures from entering turf
areas previously treated with pendimethalin.
    4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account residential exposure plus chronic exposure to food
and water (considered to be a background exposure level). Pendimethalin
is not registered for use on any sites that would result in
intermediate-term residential exposure. Therefore, the aggregate risk
is the sum of the risk from food and water, which do not exceed the
Agency's level of concern.
    5. Aggregate cancer risk for U.S. population. Pendimethalin has
been classified as a ``Group C'' (possible human) carcinogen, based on
thyroid follicular cell adenomas observed in rats. As explained in Unit
III.C.1., risk assessments based on the endpoint selected for the cPAD
are considered to be protective of any potential carcinogenic risk from
exposure to pendimethalin. Based on the results of the chronic risk
assessment discussed above in Unit III.E.2., EPA concludes that
pendimethalin is not expected to pose a cancer risk.
    6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to Pendimethalin residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology is available to enforce the
tolerance expression. The PAM VII lists four gas chromatography, with
electron capture detection (GC/ECD), methods for the determination of
pendimethalin residues of concern in plant commodities. Methods I and
III determine residues of the parent, whereas Methods II and IV
determine residues of the regulated metabolite. An adequate
confirmatory GC/MS method is also available and may be requested from:
Chief, Analytical Chemistry Branch, Environmental Science Center, 701
Mapes Rd., Ft. Meade, MD 20755-5350; telephone number:<PHONE_NUMBER>;
e-mail address<EMAIL_ADDRESS>
B. International Residue Limits

    There are currently no Canadian, Mexican, or Codex maximum residue
limits (MRLs) for pendimethalin on the commodities for which tolerances
are being established.

V. Conclusion

    Based upon review of the data supporting the petitions, EPA has
modified the proposed tolerances as

follows: Artichoke, globe from 0.05 ppm to 0.1 ppm; asparagus from 0.1
ppm to 0.15 ppm; brassica head and stem, subgroup 5-A from 0.05 ppm to
0.1 ppm; and grape from 0.05 ppm to 0.1 ppm.
    The tolerances for artichoke, globe; brassica head and stem,
subgroup 5-A; and grape were determined based on the sum of the method
Limits of Quantitation (LOQ) for parent pendimethalin (0.05 ppm) and
its regulated metabolite (0.05 ppm), since no detectable residues were
found in the submitted residue field trials.
    The tolerance for asparagus was determined using the Agency's
Tolerance Spreadsheet in accordance with the Agency's Guidance for
Setting Pesticide Tolerances Based on Field Trial Data.
    Therefore, tolerances are established for combined residues of
pendimethalin, N-(1-ethylpropyl)-3,4-dimethyl-2,6-dinitrobenzenamine,
and its metabolite, 4-[(1-ethylpropyl)amino]-2-methyl-3,5-dinitrobenzyl
alcohol, in or on artichoke, globe at 0.1 ppm; asparagus at 0.15 ppm;
brassica head and stem, subgroup 5-A at 0.1 ppm; and grape at 0.1 ppm.

VI. 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, 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) or Executive Order 13045, entitled Protection of Children
from Environmental Health Risks and Safety Risks (62 FR 19885, April
23, 1997). 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., 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).
    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.
    This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled Federalism (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 6, 2000) do not apply to this rule. In addition, This
rule does not 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).
    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).

VII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and to
the Comptroller General of the United States. EPA will submit a report
containing this rule and other required information to the U.S. Senate,
the U.S. House of Representatives, and the Comptroller General of the
United States prior to publication of this final rule in the Federal
Register. This final rule is not a ``major rule'' as defined by 5
U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: September 7, 2007.
Lois Rossi,
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 180.361 is amended by alphabetically adding the following
commodities to the table in paragraph (a) to read as follows:

180.361  Pendimethalin; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
                                * * * * *
Artichoke, globe...........................................          0.1
Asparagus..................................................         0.15
                                * * * * *
Brassica head and stem, subgroup 5-A.......................          0.1
                                * * * * *
Grape......................................................          0.1
                                * * * * *
------------------------------------------------------------------------

[FR Doc. E7-18259 Filed 9-18-07; 8:45 am]

BILLING CODE 6560-50-S