[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 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: 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 http://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: 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 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 http://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 http://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 http://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 http://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 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, 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 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 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