Pendimethalin; Pesticide Tolerances, 46377-46382 [E9-21719]
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Federal Register / Vol. 74, No. 173 / Wednesday, September 9, 2009 / Rules and Regulations
46377
Publicly available docket materials are
available in the electronic docket at
https://www.regulations.gov, or, if only
§ 180.615 Amicarbazone; tolerances for
available in hard copy, at the OPP
residues.
Regulatory Public Docket in Rm. S–
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4400, One Potomac Yard (South Bldg.),
(d) * * *
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
Commodity
Parts per million Facility telephone number is (703) 305–
5805.
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Wheat, bran ..................
0.15 FOR FURTHER INFORMATION CONTACT:
Wheat, flour ..................
0.15 Sidney Jackson, Registration Division
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(7505P), Office of Pesticide Programs,
Wheat, germ .................
0.15 Environmental Protection Agency, 1200
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Pennsylvania Ave., NW., Washington,
Wheat, middlings, .........
0.15 DC 20460–0001; telephone number:
Wheat, shorts ...............
0.15 (703) 305–7610; e-mail address:
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jackson.sidney@epa.gov.
SUPPLEMENTARY INFORMATION:
[FR Doc. E9–21416 Filed 9–8–09; 8:45 am]
the following entries to the table in
paragraph (d) to read as follows:
Commodity
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Parts per million
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39. Section 180.517 is amended by
removing the entries for ‘‘Fat of cattle,
goat, horse and sheep,’’ ‘‘Liver of cattle,
goat, horse and sheep,’’ ‘‘Meat
Byproducts, except liver of cattle, goat,
horse, and sheep,’’ and ‘‘Meat of cattle,
goat, horse and sheep’’ and adding
alphabetically the following entries to
the table in paragraph (a) to read as
follows:
■
§ 180.517
(a)
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Fipronil; tolerances for residues.
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BILLING CODE 6560–50–S
Commodity
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Cattle, fat ......................
Cattle, liver ...................
Cattle, meat ..................
Cattle, meat byproducts, except liver .......
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Goat, fat ........................
Goat, liver .....................
Goat, meat ....................
Goat, meat byproducts,
except liver ................
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Horse, fat ......................
Horse, liver ...................
Horse, meat ..................
Horse, meat byproducts, except liver .......
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Sheep, fat .....................
Sheep, liver ..................
Sheep, meat .................
Sheep, meat byproducts, except liver .......
I. General Information
Parts per million
0.40 ENVIRONMENTAL PROTECTION
0.10 AGENCY
0.04
40 CFR Part 180
0.04
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[EPA–HQ–OPP–2008–0876; FRL–8431–2]
0.40
0.10 Pendimethalin; Pesticide Tolerances
0.04
AGENCY: Environmental Protection
0.04 Agency (EPA).
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ACTION: Final rule.
0.40
0.10 SUMMARY: This regulation establishes a
0.04 tolerance for combined residues of the
herbicide pendimethalin including its
0.04 metabolites and degradates in or on
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0.40 olive at 0.1 parts per million (ppm). The
0.10 Interregional Research Project Number 4
0.04 (IR–4) requested this tolerance under
the Federal Food, Drug, and Cosmetic
0.04 Act (FFDCA).
DATES: This regulation is effective
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September 9, 2009. Objections and
■ 40. Section 180.554 is amended by
requests for hearings must be received
removing the entry for ‘‘Apple pomace’’ on or before November 9, 2009, and
and by adding alphabetically the
must be filed in accordance with the
following entries to the table in
instructions provided in 40 CFR part
paragraph (a)(1) to read as follows:
178 (see also Unit I.C. of the
SUPPLEMENTARY INFORMATION).
§ 180.554 Kresoxim-methyl; tolerances for
ADDRESSES: EPA has established a
residues.
docket for this action under docket
(a) General. (1) * * *
identification (ID) number EPA–HQ–
OPP–2008–0876. All documents in the
docket are listed in the docket index
available at https://www.regulations.gov.
Commodity
Parts per million
Although listed in the index, some
information is not publicly available,
Apple, dry pomace ....
1.0
Apple, wet pomace ...
1.0
e.g., Confidential Business Information
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(CBI) or other information whose
disclosure is restricted by statute.
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Certain other material, such as
■ 41. Section 180.615 is amended by
copyrighted material, is not placed on
removing the entry for ‘‘Wheat, milled
the Internet and will be publicly
byproducts’’ and adding alphabetically
available only in hard copy form.
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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 https://
www.regulations.gov, you may access
this Federal Register document
electronically through the EPA Internet
under the ‘‘Federal Register’’ listings at
https://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 https://www.gpoaccess.gov/ecfr
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Federal Register / Vol. 74, No. 173 / Wednesday, September 9, 2009 / Rules and Regulations
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: https://
www.regulations.gov. Follow the on-line
instructions for submitting comments.
• Mail: Office of Pesticide Programs
(OPP) Regulatory Public Docket (7502P),
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001.
• Delivery: OPP Regulatory Public
Docket (7502P), Environmental
Protection Agency, Rm. S–4400, One
Potomac Yard (South Bldg.), 2777 S.
Crystal Dr., Arlington, VA 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.
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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-di
methyl-2,6-dinitrobenzenamine and its
metabolite, 4-[(1-ethylpropyl)amino]-2-
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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,
https://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
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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 lowestobserved-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., nonlinear, RfD approach) was employed by
the Agency since mode of action studies
are available that demonstrate that the
thyroid tumors are due to a thyroidpituitary 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
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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 https://
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
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probability of an occurrence of the
adverse effect greater than that expected
in a lifetime. For more information on
the general principles EPA uses in risk
characterization and a complete
description of the risk assessment
process, see https://www.epa.gov/
pesticides/factsheets/riskassess.htm.
A summary of the toxicological
endpoints for pendimethalin used for
human risk assessment can be found at
https://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–20080876.
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
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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 https://www.epa.gov/
oppefed1/models/water/index.htm.
Based on the Pesticide Root Zone
Model/Exposure Analysis Modeling
System (PRZM/EXAMS) and Screening
Concentration in Ground Water (SCIGROW) 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 nonoccupational, 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
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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 postapplication scenarios:
i. Adult and toddler post-application
dermal exposure from contact with
treated lawns.
ii. Toddlers’ incidental ingestion of
pesticide residues on lawns from handto-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 https://
www.epa.gov/pesticides/cumulative.
D. Safety Factor for Infants and
Children
1. In general. Section 408(b)(2)(C) of
FFDCA provides that EPA shall apply
an additional tenfold (10X) margin of
safety for infants and children in the
case of threshold effects to account for
prenatal and postnatal toxicity and the
completeness of the database on toxicity
and exposure unless EPA determines
based on reliable data that a different
margin of safety will be safe for infants
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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
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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.
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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
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16:13 Sep 08, 2009
Jkt 217001
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; email address: residuemethods@epa.gov.
B. International Residue Limits
There are currently no established or
proposed Codex or Canadian Maximum
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46381
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)-3,4dimethyl-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-(1ethylpropyl)-3,4-dimethyl-2,6dinitrobenzenamine] and its metabolite
4-[(1-ethylpropyl)amino]-2-methyl-3,5dinitrobenzyl 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
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46382
Federal Register / Vol. 74, No. 173 / Wednesday, September 9, 2009 / Rules and Regulations
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.
Therefore, 40 CFR chapter I is
amended as follows:
jlentini on DSKJ8SOYB1PROD with RULES
■
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
VerDate Nov<24>2008
18:05 Sep 08, 2009
Jkt 217001
the Federal Register announcing when
OMB approval for Section 74.1284 and
information collection requirements
(revisions to FCC Form 303–S and 345)
have been received and when the
revised rule and requirements will take
§ 180.361 Pendimethalin; tolerance for
effect. This notice is consistent with the
residues.
statement in the Report and Order.
(a) General. Tolerances are
FCC Form 349 has not received OMB
established for the combined residues of approval to date. The Commission will
pendimethalin, [N-(1-ethylpropyl)-3,4publish a notice in the Federal Register
dimethyl-2,6-dinitrobenzenamine],
announcing when OMB approval has
including its metabolites and
been received.
degradates. Compliance with the
DATES: The amendments to 47 CFR
tolerance levels specified is to be
74.1284, published September 1, 2009
determined by measuring only
(74 FR 45130) are effective on October
pendimethalin, [N-(1-ethylpropyl)-3,41, 2009.
dimethyl-2,6-dinitrobenzenamine] and
its metabolite 4-[(1-ethylpropyl)amino]- FOR FURTHER INFORMATION CONTACT:
Cathy Williams, cathy.williams@fcc.gov
2-methyl-3,5-dinitrobenzyl alcohol
or on (202) 418–2918.
expressed as the stoichiometric
equivalent of pendimethalin, in or on
SUPPLEMENTARY INFORMATION: This
the following raw agricultural
document announces that, on
commodities.
September 1, 2009, OMB approved, for
a period of three years, the information
Commodity
Parts per million
collection requirement(s) contained in
Section 74.1284 of the rules and
*
*
*
*
*
Olive ................................
0.1 revisions to FCC Forms 303–S and 345.
The Commission publishes this notice
*
*
*
*
*
to announce the effective date of this
rule and requirements. If you have any
*
*
*
*
*
comments on the burden estimates
[FR Doc. E9–21719 Filed 9–8–09; 8:45 am]
listed below, or how the Commission
BILLING CODE 6560–50–S
can improve the collections and reduce
any burdens caused thereby, please
contact Cathy Williams, Federal
FEDERAL COMMUNICATIONS
Communications Commission, Room 1–
COMMISSION
C823, 445 12th Street, SW, Washington,
DC 20554. Please include OMB Control
47 CFR Part 74
Numbers, 3060–0075 (Form 345), 3060–
[MB Docket No. 07–172; FCC 09–59].
0110 (Form 303–S) and 3060–0250
(Section 74.1284) in your
Amendment of Service and Eligibility
correspondence. The Commission will
Rules for FM Broadcast Translator
also accept your comments via the
Stations
Internet if you send them to
PRA@fcc.gov.
AGENCY: Federal Communications
To request materials in accessible
Commission.
formats for people with disabilities
ACTION: Final rule; announcement of
(Braille, large print, electronic files,
effective date.
audio format), send an e–mail to
fcc504@fcc.gov or call the Consumer &
SUMMARY: In this document, the
Governmental Affairs Bureau at (202)
Commission announces that the Office
418–0530 (voice), (202) 418–0432
of Management and Budget (OMB) has
approved, for a period of three years, the (TTY).
SYNOPSIS
information collection requirements
As required by the Paperwork
associated with 47 CFR 74.1284, FCC
Reduction Act of 1995 (44 U.S.C. 3507),
Form 303–S and FCC Form 345.
the Commission is notifying the public
Therefore, this rule and forms will take
effect on October 1, 2009. On September that it received OMB approval on
September 1, 2009, for the information
1, 2009, the Commission published the
collection requirement(s) contained in
summary document of the Report and
the Commission’s rules at 47 CFR
Order, In the Matter of the Amendment
74.1284 and revisions to FCC Forms
of Service and Eligibility Rules for FM
303–S and 345.
Broadcast Translator Stations, MB
Docket No. 07–172, FCC 09–59, at 74 FR
Under 5 CFR 1320, an agency may not
45126. The Ordering Clause of the
conduct or sponsor a collection of
Report and Order stated that the
information unless it displays a current,
Commission would publish a notice in
valid OMB Control Number.
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:
■
PO 00000
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E:\FR\FM\09SER1.SGM
09SER1
Agencies
[Federal Register Volume 74, Number 173 (Wednesday, September 9, 2009)]
[Rules and Regulations]
[Pages 46377-46382]
From the Federal Register Online via the Government Printing 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 https://www.regulations.gov. Although listed in the index, some information is
not publicly available, e.g., Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute. Certain
other material, such as copyrighted material, is not placed on the
Internet and will be publicly available only in hard copy form.
Publicly available docket materials are available in the electronic
docket at https://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket Facility telephone number is (703)
305-5805.
FOR FURTHER INFORMATION CONTACT: 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
https://www.regulations.gov, you may access this Federal Register
document electronically through the EPA Internet under the ``Federal
Register'' listings at https://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 https://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: https://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA 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, https://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 https://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 https://www.epa.gov/pesticides/factsheets/riskassess.htm.
A summary of the toxicological endpoints for pendimethalin used for
human risk assessment can be found at https://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 https://www.epa.gov/oppefed1/models/water/index.htm.
Based on the Pesticide Root Zone Model/Exposure Analysis Modeling
System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI-
GROW) models, the estimated drinking water concentrations (EDWCs) of
pendimethalin 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 https://www.epa.gov/pesticides/cumulative.
D. Safety Factor for Infants and Children
1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the 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]
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