[Federal Register Volume 74, Number 173 (Wednesday, September 9, 2009)]
[Rules and Regulations]
[Pages 46377-46382]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-21719]


-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2008-0876; FRL-8431-2]


Pendimethalin; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This regulation establishes a tolerance for combined residues 
of the herbicide pendimethalin including its metabolites and degradates 
in or on olive at 0.1 parts per million (ppm). The Interregional 
Research Project Number 4 (IR-4) requested this tolerance under the 
Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective September 9, 2009. Objections and 
requests for hearings must be received on or before November 9, 2009, 
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 http://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 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: Sidney Jackson, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-7610; e-mail address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to 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 Access Electronic Copies of this Document?

    In addition to accessing electronically available documents 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 e-CFR cite 
at http://www.gpoaccess.gov/ecfr

[[Page 46378]]

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 November 9, 2009.
    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: 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 22202. 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 
8E7404) by IR-4, 500 College Road East, Suite 201 W, Princeton, NJ 
08540. The petition requested that 40 CFR 180.361 be amended by 
establishing tolerances for combined residues of the herbicide 
pendimethalin, N-(ethylpropyl)-3,4-dimethyl-2,6-dinitrobenzenamine and 
its metabolite, 4-[(1-ethylpropyl)amino]-2-methyl-3, 5-dinitrobenzyl 
alcohol in or on olive at 0.1 parts per million (ppm). That notice 
referenced a summary of the petition prepared by BASF Corporation, the 
registrant, on behalf of IR-4 and is available to the public in the 
docket, http://www.regulations.gov. There were no comments received in 
response to the notice of filing.

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 including its 
metabolites and degradates on olive at 0.1 ppm. EPA's assessment of 
exposures and risks associated with establishing tolerances follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered their 
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 moderate oral and eye toxicity and low dermal and 
inhalation toxicity. Pendimethalin is not a dermal sensitizer. The 
target organ for pendimethalin in chronic and subchronic rat and mouse 
studies is the thyroid. Effects seen in these studies include 
alterations in thyroid hormones, increased thyroid weight, and 
microscopic thyroid lesions (including increased thyroid follicular 
cell height, follicular cell hyperplasia, as well as follicular cell 
adenomas).
    Prenatal developmental toxicity studies in rats and rabbits show no 
indication of qualitative or quantitative susceptibility following 
prenatal and postnatal exposure in 2-generation reproduction studies in 
rats. A developmental thyroid study has been requested to provide 
additional information to evaluate thyroid toxicity in the developing 
fetus following prenatal and postnatal exposure.
    In a combined chronic/carcinogenicity study in rats, the lowest-
observed-adverse-effect level (LOAEL) of 250 milligrams/kilogram/day 
(mg/kg/day) is based on decreased survival, body weight gain and food 
consumption, increased gamma glutamyl transferase and cholesterol, 
increase in absolute and/or relative liver weight, generalized icterus, 
dark adipose tissue in females, diffusely dark thyroids and follicular 
cell hyperplasia of the thyroid. Thyroid tumors were observed in both 
male and female rats. In the carcinogenicity study in mice, the LOAELs 
of 622.1 and 806.99 mg/kg/day for males and females, respectivley, are 
based on increased mortality in females, decreased body weight in 
females, increased absolute thyroid, liver and gall bladder weights 
and/or relative body and brain weight ratios in males and females as 
well as amyloidosis in males. There were no tumors observed in mice.
    Pendimethalin is classified as a ``Group C'', possible human 
carcinogen, based on a statistically significant increased 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.
    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 following chronic exposure and the likelihood that 
pendimethalin may cause disruption in the thyroid, the Agency

[[Page 46379]]

required a developmental thyroid study to be submitted to further 
characterize these effects.
    There is no evidence of neurotoxicity or potential immunotoxicity 
for pendimethalin in the toxicology database. An immunotoxicity and 
acute and subchronic neurotoxicity studies are required as part of the 
revised 40 CFR part 158 toxicology data requirements for pendimethalin.
    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 LOAEL from the toxicity studies 
can be found at http://www.regulations.gov in document ``Pendimethalin: 
Human Health Risk and Exposure Assessment for Proposed Section 3 
Registration for Use on Olive,'' dated May 28, 2009, at 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 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 and Exposure Assessment for 
Proposed Section 3 Registration for Use on Olive,'' dated May 28, 2009, 
at page 10 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, 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 Dietary Exposure Evaluation Model (DEEM-FCID, 
version 2.00), which uses food consumption data from the U.S. 
Department of Agriculture (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
    b. All crops for which tolerances exist or are proposed were 
treated, i.e., 100% crop treated (CT).
In estimating residues in processed commodities EPA used empirical 
processing factors obtained from the processing studies, where 
available; maximum theoretical concentration factors of 8.0 for the 
processed commodities of wheat bran and wheat germ and 1.4 for wheat 
flour; and DEEM 7.81 default-processing factors were used for the 
remaining processed commodities.
    iii. Cancer. As explained in Unit II.A., EPA has concluded that the 
chronic risk assessment will be protective of the precursor events that 
have led to cancer effects in animal studies. Therefore, a separate 
quantitative dietary exposure assessment to evaluate cancer risk was 
not conducted.
    iv. Anticipated residue and percent crop treated. The Agency did 
not use anticipated residue or percent crop treated (PCT) in the 
dietary assessment for pendimethalin. The assumption of 100% CT and 
tolerance level residues was made for all registered and proposed food 
commodity uses of pendimethalin.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for pendimethalin in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
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 drinking water concentrations (EDWCs) of 
pendimethalin were estimated. Modeled estimates of drinking water were 
entered into the dietary exposure model. For chronic exposures for non-
cancer assessments, the concentration values of pendimethalin are 
estimated to be 6.0 ppb for surface water and 0.036 ppb for ground 
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

[[Page 46380]]

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:
    i. Adult and toddler post-application dermal exposure from contact 
with treated lawns.
    ii. Toddlers' incidental ingestion of pesticide residues on lawns 
from hand-to-mouth transfer.
    iii. Toddlers' object-to-mouth transfer from mouthing of pesticide-
treated turfgrass.
    iv. 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 EPA 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.''
    EPA has not found pendimethalin to share a common mechanism of 
toxicity with 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 assumed that 
pendimethalin 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 Web site at http://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 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, in order 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 safety factor should be retained for the 
subchronic and chronic thyroid endpoints:
    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.
    ii. There was no indication of pendimethalin neurotoxicity in 
subchronic or chronic toxicity studies and there is no need for a 
developmental neurotoxicity study or additional UFs to account for 
neurotoxicity.
    iii. 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, as discussed above, a developmental 
thyroid toxicity study has been required.
    iv. The available studies do not indicate potential immunotoxicity 
and pendimethalin does not belong to the class of compounds (e.g., the 
organotins, heavy metals, or halogenated aromatic hydrocarbons) that 
would be expected to be toxic to the immune system. Based on the 
available data the immunotoxicity is not expected to provide a Point of 
Departure (POD) lower than that currently used for overall risk 
assessments. Therefore, at this time a database uncertainty factor is 
not needed for the lack of these studies.
    v. There are no residual uncertainties identified in the exposure 
databases. The chronic food exposure assessments are considered to be 
highly conservative, as they assume that all crops registered and 
proposed have residues at tolerance-level. The drinking water estimates 
were derived from conservative screening models. The residential 
exposure assessment utilizes reasonable high-end variables set out in 
EPA's Residential Exposure SOPs (Standard Operating Procedures). The 
aggregate assessment is based upon reasonable high-end residential 
exposure assumptions, and is also not likely to under estimate exposure 
to any subpopulation, including those comprised of infants and 
children.

[[Page 46381]]

    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 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 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 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 is not expected.
    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 is currently registered for use(s) 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.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded that the combined short-term food, 
water, and residential exposures 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 at an application rate (to 
residential turf) of 2 lbs active ingredient/Acre (ai/A), and a total 
MOE of 340 for an application rate of 3 lbs ai/A. As the level of 
concern is for MOEs that are lower than 300, 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 is not registered for any use patterns that would 
result in intermediate-term residential exposure. Therefore, the 
intermediate-term aggregate risk is the sum of the risk from exposure 
to pendimethalin 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 
II.A., the chronic risk assessment is considered to be protective of 
any cancer effects.
    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, liquid chromatography/mass 
spectrometry (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: 
[email protected].

B. International Residue Limits

    There are currently no established or proposed Codex or Canadian 
Maximum Residue Levels (MRLs) for pendimethalin. Mexico has established 
MRLs (expressed as pendimethalin per se) for several crops but none for 
olives.

V. Conclusion

    Therefore, a tolerance is established for combined residues of 
pendimethalin, [N-(1-ethylpropyl)-3,4-dimethyl-2,6-dinitrobenzenamine], 
including its metabolites and degradates, in or on olive at 0.1 ppm. 
Compliance with the tolerance levels specified is to be determined by 
measuring only 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 the commodity.

 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

[[Page 46382]]

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: September 1, 2009.
 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 revising the introductory text to 
paragraph (a) and adding alphabetically an entry for ``olive'' to the 
table in paragraph (a) to read as follows:


Sec.  180.361  Pendimethalin; tolerance for residues.

    (a) General. Tolerances are established for the combined residues 
of pendimethalin, [N-(1-ethylpropyl)-3,4-dimethyl-2,6-
dinitrobenzenamine], including its metabolites and degradates. 
Compliance with the tolerance levels specified is to be determined by 
measuring only 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 the following raw agricultural 
commodities.

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
                                * * * * *
Olive................................................                0.1
                                * * * * *
------------------------------------------------------------------------

* * * * *

[FR Doc. E9-21719 Filed 9-8-09; 8:45 am]
BILLING CODE 6560-50-S 7