[Federal Register: September 9, 2009 (Volume 74, Number 173)]
[Rules and Regulations]
[Page 46377-46382]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09se09-26]
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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.
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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: jackson.sidney@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 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:
residuemethods@epa.gov.
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