Document ID: EPA-HQ-OPP-2007-0106-0003
Agency: epa
Document Type: Rule
Title: Pendimethalin; Pesticide Tolerance
Posted Date: 2007-09-19T04:00Z

[Federal Register: September 19, 2007 (Volume 72, Number 181)]
[Rules and Regulations]               
[Page 53436-53440]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[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 (703) 305-5805.

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: (703) 305-5218; e-mail address: stanton.susan@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 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 (703) 305-5805.

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

[[Page 53437]]

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

[[Page 53438]]

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

[[Page 53439]]

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: (410) 305-2905; 
e-mail address: residuemethods@epa.gov.

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

[[Page 53440]]

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]

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