Pendimethalin; Pesticide Tolerances, 4279-4284 [2010-1610]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 75, Number 17 (Wednesday, January 27, 2010)]
[Rules and Regulations]
[Pages 4279-4284]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-1610]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2008-0876; FRL-8804-2]


Pendimethalin; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for combined residues 
or residues of pendimethalin, N-(1-ethylpropyl)-3,4-dimethyl-2,6-
dinitrobenzenamine, in or on grass forage, fodder, and hay crop group 
17, forage; grass forage, fodder, and hay crop group 17, hay; and grass 
forage, fodder, and hay crop group 17, straw. BASF Corporation 
requested these tolerances under the Federal Food, Drug, and Cosmetic 
Act (FFDCA).

DATES: This regulation is effective January 27, 2010. Objections and 
requests for hearings must be received on or before March 29, 2010, 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-2008-0876. All documents in the 
docket are listed in the docket index available at https://www.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 https://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: Phil Errico, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-6663; e-mail address: errico.philip@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).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    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 Get Electronic Access to Other Related Information?

    You may access a frequently updated electronic version of EPA's 
tolerance regulations at 40 CFR part 180 through the Government 
Printing Office's e-CFR cite at https://www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, 21 U.S.C. 346a, 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-2008-0876 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 March 29, 2010.
    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-2008-0876, by one of the following methods:
     Federal eRulemaking Portal: https://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 Facility'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 13, 2009 (74 FR 16866) (FRL-8396-
6), 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 
8F7396) by BASF Corporation, 26 Davis Drive, Research Triangle Park, NC 
27709-3528. 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, expressed as the stoichiometric equivalent of pendimethalin, 
in or on grass forage, fodder, and hay crop group 17, forage; grass 
forage, fodder, and hay crop group 17, hay; and grass forage, fodder, 
and hay crop group 17, straw at 40 parts per million (ppm), 80 ppm, and 
4.5 ppm, respectively. That notice referenced a summary of the petition 
prepared by BASF Corporation, the registrant, which is available to the 
public in the docket, at https://www.regulations.gov. There were no 
comments received in response to the notice of filing.

[[Page 4280]]

    Based upon review of the data supporting the petition, EPA has 
changed the requested tolerances for the combined residues for 
pendimethalin and its metabolite in or on grass forage, fodder, and 
hay, crop group 17, forage; grass forage, fodder, and hay, crop group 
17, hay; and grass forage, fodder, and hay crop group 17, straw from 40 
ppm, 80 ppm, and 4.5 ppm, respectively, to 20 ppm, 13 ppm, and 4.0 ppm, 
respectively. EPA also changed the commodities names to reflect the 
regulatory names as stated in 40 CFR 180.41(c). The reason for these 
changes are explained in Unit IV.C.

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. . . 
.''
    Consistent with section 408(b)(2)(D) of FFDCA, and the factors 
specified in 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 for the petitioned-for 
tolerances for combined residues of pendimethalin, N-(1-ethylpropyl)-
3,4-dimethyl-2,6-dinitrobenzenamine, on grass forage, fodder, and hay 
crop group 17, forage; grass forage, fodder, and hay crop group 17, 
hay; grass forage, fodder, and hay, crop group 17, straw at 20 ppm, 13 
ppm, and 4.0 ppm, respectively. EPA's assessment of exposures and risks 
associated with establishing tolerances 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.
    Pendimethalin has low acute oral, dermal, and inhalation toxicity, 
and is not a dermal sensitizer. The thyroid is a target organ for 
pendimethalin. Thyroid toxicity in chronic and subchronic rat and mouse 
studies was manifested as alterations in thyroid hormones, increased 
thyroid weight, and microscopic thyroid lesions. The available prenatal 
and postnatal developmental toxicity data provided no indication of 
qualitative or quantitative susceptibility to the young. Pendimethalin 
is considered a possible human carcinogen based on a statistically 
significant increased trend and pair-wise comparison between the high 
dose group and controls for thyroid folliculate cell adenomas in male 
and female rats. A threshold approach is being used to evaluate cancer 
risk because mode of action studies are available demonstrating that 
the thyroid tumors are due to a thyroid-pituitary imbalance (a 
threshold effect), and also because pendimethalin was shown to be non-
mutagenic in mammaliam somatic cells and germ cells. Specific 
information on the studies received and the nature of the adverse 
effects caused by pendimethalin, N-(1-ethylpropyl)-3,4-dimethyl-2,6-
dinitrobenzenamine, 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 https://www.regulations.gov in the 
document titled ``Pendimethalin: Human Health Risk and Exposure 
Assessment for Proposed Section 3 Registration for use on Grasses for 
Seed Production and Dormant Bermudagrass Pasture and Hay Fields,'' page 
10, in docket ID number EPA-HQ-OPP-2008-0876.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no 
appreciable risk, a toxicological point of departure (POD) is 
identified as the basis for derivation of reference values for risk 
assessment. The POD may be defined as 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) or a benchmark dose (BMD) approach 
is sometimes used for risk assessment. Uncertainty/safety factors (UFs) 
are used in conjunction with the POD 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 
dietary risks by comparing aggregate food and water 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 POD by all applicable UFs. Aggregate short-, intermediate-
, and chronic-term risks are evaluated by comparing food, water, and 
residential exposure to the POD to ensure that the margin of exposure 
(MOE) called for by the product of all applicable UFs is not exceeded. 
This latter value is referred to as the level of concern (LOC).
    For non-threshold risks, the Agency assumes that any amount of 
exposure will lead to some degree of risk. Thus, the Agency estimates 
risk in terms of the probability of an occurrence of the adverse effect 
greater than that expected in a lifetime. For more information on the 
general principles EPA uses in risk characterization and a complete 
description of the risk assessment process, see https://www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for pendimethalin, N-(1-
ethylpropyl)-3,4-dimethyl-2,6-dinitrobenzenamine, used for human risk 
assessment can be found at https://www.regulations.gov in the document 
titled ``Pendimethalin: Human Health Risk and Exposure Assessment for 
Proposed Section 3 Registration for use on Grasses for Seed Production 
and Dormant Bermudagrass Pasture and Hay Fields,'' page 29 in docket ID 
number EPA-HQ-OPP-2008-0876.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to pendimethalin, N-(1-ethylpropyl)-3,4-dimethyl-2,6-
dinitrobenzenamine, EPA considered exposure under the petitioned-for 
tolerances as well as all existing pendimethalin, N-(1-ethylpropyl)-
3,4-dimethyl-2,6-dinitrobenzenamine, tolerances in (40 CFR 180.361). 
EPA assessed dietary exposures from pendimethalin, N-(1-ethylpropyl)-
3,4-dimethyl-2,6-dinitrobenzenamine, 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

[[Page 4281]]

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, N-(1-ethylpropyl)-3,4-dimethyl-2,6-dinitrobenzenamine; 
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 USDA 1994-1996 
and 1998 Nationwide Continuing Surveys of Food Intake by Individuals 
(CSFII). As to residue levels in food, the chronic dietary exposure 
analysis was based on the following assumptions:
    a. All currently registered raw agricultural commodities (RACs) and 
all proposed uses on RACs have tolerance level residues of 
pendimethalin and its metabolite, 4-[(1-ethylpropy)amino]-2-methyl-3,5-
dinitrobenzyl alcohol.
    b. All crops for which tolerances exist or are proposed were 
treated, i.e., 100 percent crop treated (PCT).
    iii. Cancer. Pendimethalin is classified as a ``Group C,'' possible 
human carcinogen, based on a statistically significant increase trend 
and pair-wise comparison between the high dose group and controls for 
thyroid follicular cell adenomas in male and female rats. A non-
quantitative approach (i.e., non-linear, RfD approach) was employed by 
the Agency since mode of action studies are available that demonstrate 
that the thyroid tumors are due to a thyroid-pituitary imbalance. 
Pendimethalin was shown to be non-mutagenic in mammalian somatic cells 
and germ cells. Cancer risk was assessed using the same estimates as 
discussed in Unit III.C.1.ii., chronic exposure. Based on concern for 
the hormonal changes (alterations in thyroid weights and 
histopathological lesions) seen in several studies following oral 
administration of pendimethalin for 14, 28, and 92 days, as well as the 
following chronic exposure and the likelihood that pendimethalin may 
cause disruption in the thyroid, the Agency has required a 
developmental thyroid study to further characterize these effects. This 
study has not been submitted.
    iv. Anticipated residue and PCT information. EPA did not use 
anticipated residue and/or PCT information in the dietary assessment 
for pendimethalin, N-(1-ethylpropyl)-3,4-dimethyl-2,6-
dinitrobenzenamine. Tolerance level residues and/or 100 PCT were 
assumed for all food commodities.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for pendimethalin, N-(1-ethylpropyl)-3,4-dimethyl-2,6-
dinitrobenzenamine, in drinking water. These simulation models take 
into account data on the physical, chemical, and fate/transport 
characteristics of pendimethalin, N-(1-ethylpropyl)-3,4-dimethyl-2,6-
dinitrobenzenamine. Further information regarding EPA drinking water 
models used in pesticide exposure assessment can be found at https://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 drinking water concentrations (EDWCs) of 
pendimethalin, N-(1-ethylpropyl)-3,4-dimethyl-2,6-dinitrobenzenamine, 
acute exposures are estimated to be 77.7 parts per billion (ppb) for 
surface water and 0.036 ppb for ground water. Chronic exposures for 
non-cancer assessments are estimated to be 6.0 ppb for surface water 
and 0.036 ppb for ground water, and for chronic exposures for cancer 
assessments are estimated to be 4.8 ppb for surface water. Due to the 
tight sorption to soil, pendimethalin is not considered a cancer risk 
in ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model for PRZM-EXAMS concentrations.
    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, N-(1-ethylpropyl)-3,4-dimethyl-2,6-
dinitrobenzenamine, is currently registered for the following uses that 
could result in residential exposures: Turf grass. EPA assessed 
residential exposure using the following assumptions: The scenarios 
used were short-term in duration and consisted of dermal (for adults 
and children), and oral (hand-to-mouth, and soil ingestion, for 
children only) exposure. The level of concern for oral, dermal, and 
inhalation exposure is an MOE of less than 300.
    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.''
    EPA has not found pendimethalin, N-(1-ethylpropyl)-3,4-dimethyl-
2,6-dinitrobenzenamine, to share a common mechanism of toxicity with 
any other substances, and pendimethalin, N-(1-ethylpropyl)-3,4-
dimethyl-2,6-dinitrobenzenamine, does not appear to produce a toxic 
metabolite produced by other substances. For the purposes of this 
tolerance action, therefore, EPA has assumed that pendimethalin, N-(1-
ethylpropyl)-3,4-dimethyl-2,6-dinitrobenzenamine, does not have 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 https://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) 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 Food Quality 
Protection Act (FQPA) safety factor (SF). In applying this provision, 
EPA either retains the default value of 10X, or uses a different 
additional safety factor when reliable data available to EPA support 
the choice of a different factor.
    2. Prenatal and postnatal sensitivity. The Agency concluded there 
is potential for prenatal and/or postnatal toxicity (thyroid) in 
developing offspring resulting from exposure to pendimethalin. There 
was no indication of prenatal and/or postnatal qualitative or 
quantitative increased susceptibility in the developmental studies in 
rats and rabbits or the 2-generation reproduction studies in rats. 
However, because developmental LOAELs for thyroid toxicity could not be 
determined in the developmental studies, the Agency has requested 
developmental thyroid toxicity data to determine potential thyroid 
toxicity following prenatal and/or postnatal exposure to pendimethalin.
    3. Conclusion. Based on the following considerations, EPA has 
determined that the FQPA SF should be retained for the subchronic and 
chronic thyroid endpoints:

[[Page 4282]]

    i. The toxicity database for pendimethalin is not complete. 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.
    In accordance with 40 CFR part 158 Toxicology Data Requirements, 
acute and subchronic neurotoxicity studies and an immunotoxicity study 
are required for pendimethalin. However, since there was no evidence of 
neurotoxic clinical signs, changes in brain weight, or histopathology 
of the nervous system in any study with pendimethalin, the Agency 
determined that an additional factor for database uncertainties is not 
needed to account for lack of these data. Additionally, there is no 
need for a developmental neurotoxicity study. In the absence of 
specific immunotoxicity studies, EPA has evaluated the available 
pendimethalin toxicity data to determine whether an additional database 
uncertainty factor is needed to account for potential immunotoxicity. 
There are no indications in the available studies that organs 
associated with immune function, such as the thymus and spleen, are 
affected by pendimethalin, and pendimethalin does not belong to a class 
of chemicals (e.g., the organotins, heavy metals, or halogenated 
aromatic hydrocarbons) that would be expected to be immunotoxic.
    Therefore, the Agency determined that an additional uncertainty 
factor for database uncertainties is not need to account for lack of 
these data.
    ii. There was no indication of prenatal and/or postnatal 
qualitative or quantitative increased susceptibility in the 
developmental studies in rats and rabbits or the 2-generation 
reproduction studies in rats. However, the developmental studies in 
rats and rabbits were not adequate to determine the potential for 
thyroid toxicity during development. Consequently, there is concern for 
potential increased sensitivity or susceptibility in offspring 
regarding thyroid effects, and a developmental thyroid toxicity study 
has been required.
    iii. 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. EPA made conservative 
(protective) assumptions in the ground and surface water modeling used 
to assess exposure to pendimethalin, N-(1-ethylpropyl)-3,4-dimethyl-
2,6-dinitrobenzenamine, in drinking water. EPA used similarly 
conservative assumptions to assess postapplication exposure of children 
as well as incidental oral exposure of toddlers. These assessments will 
not underestimate the exposure and risks posed by pendimethalin, N-(1-
ethylpropyl)-3,4-dimethyl-2,6-dinitrobenzenamine.
    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 SF for all subchronic and 
chronic exposures whose endpoint is based on thyroid effects. 
Pendimethalin has not been shown to cause acute effects. EPA has also 
determined that the traditional 10X uncertainty factor to account for 
interspecies variation may be reduced to 3X for these subchronic and 
chronic exposures, 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

    EPA determines whether acute and chronic pesticide exposures are 
safe by comparing aggregate exposure estimates to the aPAD and cPAD. 
The aPAD and cPAD represent the highest safe exposures, taking into 
account all appropriate SFs. EPA calculates the aPAD and cPAD by 
dividing the POD by all applicable UFs. For linear cancer risks, EPA 
calculates the probability of additional cancer cases given the 
estimated aggregate exposure. Short-, intermediate-, and chronic-term 
risks are evaluated by comparing the estimated aggregate food, water, 
and residential exposure to the POD to ensure that the MOE called for 
by the product of all applicable UFs is not exceeded.
    1. Acute risk. An acute aggregate risk assessment takes into 
account exposure estimates from acute dietary consumption of food and 
drinking water. No adverse effect resulting from a single-oral exposure 
was identified and no acute dietary endpoint was selected. Therefore, 
pendimethalin, N-(1-ethylpropyl)-3,4-dimethyl-2,6-dinitrobenzenamine, 
is not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
pendimethalin, N-(1-ethylpropyl)-3,4-dimethyl-2,6-dinitrobenzenamine, 
from food and water will utilize 15% of the cPAD for children 1 to 2 
years old, the population group receiving the greatest exposure. Based 
on the explanation in Unit III.C.3., regarding residential use 
patterns, chronic residential exposure to residues of pendimethalin, N-
(1-ethylpropyl)-3,4-dimethyl-2,6-dinitrobenzenamine, is not expected to 
exceed the MOEs of concern.
    3. Short-term risk. Short-term aggregate exposure takes into 
account short-term residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level).
    Pendimethalin, N-(1-ethylpropyl)-3,4-dimethyl-2,6-
dinitrobenzenamine, 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 exposure through food and water 
with short-term residential exposures to pendimethalin, N-(1-
ethylpropyl)-3,4-dimethyl-2,6-dinitrobenzenamine.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water, 
and residential exposures aggregated result in aggregate MOEs of 650 
for adult males and 580 for adult females. The aggregate exposure 
estimate for children results in a total MOE of 350 and 340 due to a 
residential exposure estimate of 0.024 mg/kg/day and 0.025 mg/kg/day 
when children are exposed to application rates (to residential turf) of 
2 lbs ai/Acre and 3 lbs ai/Acre, respectively. The level of concern is 
a value less than 300, therefore these MOEs are not of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level).
    Pendimethalin, N-(1-ethylpropyl)-3,4-dimethyl-2,6-
dinitrobenzenamine, is not registered for any use patterns that would 
result in intermediate-term residential exposure. Therefore, the 
intermediate-term aggregate risk is the

[[Page 4283]]

sum of the risk from exposure to pendimethalin, N-(1-ethylpropyl)-3,4-
dimethyl-2,6-dinitrobenzenamine, through food and water, which has 
already been addressed, and will not be greater than the chronic 
aggregate risk.
    5. Aggregate cancer risk for U.S. population. As explained in Unit 
III.C.iii, the chronic risk assessment is considered to be protective 
of any cancer effects since available studies demonstrate that the 
thyroid tumors are due to a thyroid pituitary imbalance, and 
pendimethalin was shown to be non-mutagenic in mammalian somatic cells 
and germ cells.
    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, N-(1-ethylpropyl)-3,4-dimethyl-2,6-
dinitrobenzenamine, residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology, using liquid chromatography/mass 
spectrometry analysis (LC/MS/MS), 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 currently no established or proposed Codex Maximum 
Residue Levels (MRLs) for pendimethalin.

C. Revisions to Petitioned-For Tolerances

    EPA has revised the requested tolerances to reflect the residue 
chemistry data submitted to support the proposed label for the use of 
pendimethalin on grass grown for seed and dormant Bermuda grass as 
requested by the petitioner. The commodity names were also changed to 
coincide with the regulatory Crop Group names as stated in 40 CFR 
180.41(c).

V. Conclusion

    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, expressed as the stoichiometric equivalent of pendimethalin, 
in or on grass forage, fodder, and hay, crop group 17, forage; grass 
forage, fodder, and hay, crop group 17, hay; grass forage, fodder, and 
hay, crop group 17, straw at 20 ppm, 13 ppm, and 4.0 ppm, respectively.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances 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 final rule has been 
exempted from review under Executive Order 12866, this final rule is 
not subject to Executive Order 13211, entitled 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 9, 2000) do not apply to this final rule. In addition, 
this final 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: January 19, 2010.
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:


Sec.  180.361  Pendimethalin; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
                                * * * * *
Grass forage, fodder, and hay crop group 17, forage..                 20
Grass forage, fodder, and hay crop group 17, hay.....                 13

[[Page 4284]]

 
Grass forage, fodder, and hay crop group 17, straw...                4.0
                                * * * * *
------------------------------------------------------------------------

* * * * *

[FR Doc. 2010-1610 Filed 1-26-10; 8:45 am]
BILLING CODE 6560-50-S