Pyrimethanil; Pesticide Tolerances, 32443-32448 [E9-15942]
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Federal Register / Vol. 74, No. 129 / Wednesday, July 8, 2009 / Rules and Regulations
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: June 19, 2009.
Steven Bradbury,
Acting Director, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
■
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.
2. Section 180.647 is added to read as
follows:
■
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§ 180.647 d-Phenothrin; tolerances for
residues.
(a) General. A tolerance of 0.01 parts
per million is established for residues of
the insecticide d-phenothrin in or on all
food/feed crops following wide-area
mosquito adulticide applications.
(b) Section 18 emergency exemptions.
[Reserved]
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(c) Tolerances with regional
registrations. [Reserved]
(d) Indirect or inadvertent residues.
[Reserved]
[FR Doc. E9–15937 Filed 7–7–09; 8:45 am]
BILLING CODE 6560–50–S
32443
FOR FURTHER INFORMATION CONTACT:
Susan Stanton, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
(703) 305–5218; e-mail address:
stanton.susan@epa.gov.
ENVIRONMENTAL PROTECTION
AGENCY
SUPPLEMENTARY INFORMATION:
40 CFR Part 180
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.
[EPA–HQ–OPP–2008–0478; FRL–8423–6]
Pyrimethanil; Pesticide Tolerances
AGENCY: Environmental Protection
Agency (EPA).
ACTION: Final rule.
SUMMARY: This regulation replaces
existing tolerances for residues of
pyrimethanil on fruit, citrus, group 10
postharvest; and fruit, stone, group 12,
except cherry with tolerances for
residues of pyrimethanil in or on fruit,
citrus, group 10, except lemon,
postharvest; fruit, stone, group 12; and
lemon, preharvest and postharvest.
Interregional Research Project Number 4
(IR-4) requested these tolerances under
the Federal Food, Drug, and Cosmetic
Act (FFDCA).
DATES: This regulation is effective July
8, 2009. Objections and requests for
hearings must be received on or before
September 8, 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–2008–0478. 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.
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I. General Information
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.
To access the OPPTS Harmonized
Guidelines referenced in this document,
go directly to the guidelines at https://
www.epa.gpo/opptsfrs/home/
guidelin.htm.
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
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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–2008–0478 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 September 8, 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–2008–0478, by one of the
following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the on-line
instructions for submitting comments.
• Mail: Office of Pesticide Programs
(OPP) Regulatory Public Docket (7502P),
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001.
• Delivery: OPP Regulatory Public
Docket (7502P), Environmental
Protection Agency, Rm. S–4400, One
Potomac Yard (South Bldg.), 2777 S.
Crystal Dr., Arlington, VA. Deliveries
are only accepted during the Docket
Facility’s normal hours of operation
(8:30 a.m. to 4 p.m., Monday through
Friday, excluding legal holidays).
Special arrangements should be made
for deliveries of boxed information. The
Docket Facility telephone number is
(703) 305–5805.
II. Petition for Tolerance
In the Federal Register of July 9, 2008
(73 FR 39289) (FRL–8371–2), 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 8E7353) by IR-4,
500 College Road East, Suite 201W,
Princeton, NJ 08540. The petition
requested that 40 CFR 180.518 be
amended by establishing tolerances for
residues of the fungicide pyrimethanil,
4,6-dimethyl-N-phenyl-2pyrimidinamine, in or on fruit, citrus,
(except lemon), group 10 (postharvest)
at 10 parts per million (ppm); lemon at
11 ppm; and fruit, stone, group 12 at 10
ppm; and removing existing tolerances
for residues of pyrimethanil on fruit,
citrus, group 10 postharvest at 10 ppm;
and fruit stone, group 12, except cherry
at 3.0 ppm. That notice referenced a
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summary of the petition prepared by
Bayer CropScience, the registrant, on
behalf of IR-4, which is available to the
public in the docket, https://
www.regulations.gov. There were no
comments received in response to the
notice of filing.
Based upon review of the data
supporting the petition, EPA has made
minor changes to the citrus commodity
definitions. The reason for these
changes is explained in Unit IV.C.
III. Aggregate Risk Assessment and
Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA
allows EPA to establish a tolerance (the
legal limit for a pesticide chemical
residue in or on a food) only if EPA
determines that the tolerance is ‘‘safe.’’
Section 408(b)(2)(A)(ii) of FFDCA
defines ‘‘safe’’ to mean that ‘‘there is a
reasonable certainty that no harm will
result from aggregate exposure to the
pesticide chemical residue, including
all anticipated dietary exposures and all
other exposures for which there is
reliable information.’’ This includes
exposure through drinking water and in
residential settings, but does not include
occupational exposure. Section
408(b)(2)(C) of FFDCA requires EPA to
give special consideration to exposure
of infants and children to the pesticide
chemical residue in establishing a
tolerance and to ‘‘ensure that there is a
reasonable certainty that no harm will
result to infants and children from
aggregate exposure to the pesticide
chemical residue. . . .’’
Consistent with section 408(b)(2)(D)
of FFDCA, and the factors specified in
section 408(b)(2)(D) of FFDCA, EPA has
reviewed the available scientific data
and other relevant information in
support of this action. EPA has
sufficient data to assess the hazards of
and to make a determination on
aggregate exposure for the petitioned-for
tolerances for residues of pyrimethanil
on fruit, citrus, group 10, except lemon,
postharvest at 11 ppm; fruit, stone,
group 12 at 10 ppm; and lemon,
preharvest and postharvest at 11 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 its validity,
completeness, and reliability as well as
the relationship of the results of the
studies to human risk. EPA has also
considered available information
concerning the variability of the
sensitivities of major identifiable
subgroups of consumers, including
infants and children.
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Pyrimethanil is of low acute toxicity
by the oral, inhalation, and dermal
routes of exposure. It is slightly
irritating to the eyes and non-irritating
to the skin in rabbit studies.
Pyrimethanil is not a dermal sensitizer.
Subchronic and chronic repeated oral
toxicity studies in rats, mice, and dogs
primarily resulted in decreased body
weight and body-weight gains, often
accompanied by decreased food
consumption. The major target organs in
rats and mice were the liver and
thyroid. In subchronic studies in rats
and mice, liver toxicity was manifested
as increased absolute and relative liver
weights. Histopathological changes in
the liver were primarily associated with
increased evidence of hypertrophy in
centrilobular hepatocytes. In a
subchronic toxicity study in mice,
increases in absolute thyroid weight
were observed, associated with
exfoliative necrosis and pigmentation of
follicular cells. In a subchronic toxicity
study in rats, thyroid effects were
manifested as an increased incidence
and severity of follicular epithelial
hypertrophy and follicular epithelial
brown pigment.
EPA classified pyrimethanil as a
Group C (possible human) carcinogen,
based on an increased incidence of
thyroid follicular cell tumors observed
in the chronic/carcinogenicity study in
rats. There was no evidence of
carcinogenicity in mice; however, the
dosing in this study was not considered
to be adequate to assess the potential
carcinogenicity. Therefore, EPA is
requesting a repeat of the mouse
carcinogenicity study. Based on the
presence of thyroid tumors in rats, EPA
has determined that a margin of
exposure (MOE) approach is appropriate
for quantification of risk. This
determination is based on evidence that
pyrimethanil appears to induce thyroid
tumors through a disruption in the
thyroid-pituitary status and thus may
have a threshold for tumor
development. This decision was
supported by the weight of the
evidence, considering the neoplastic,
related nonneoplastic and/or hormonal
effects in the male rat thyroid and liver.
A point of departure (POD) of 17
milligrams/kilograms/day (mg/kg/day),
based on the thyroid precursor lesions
is used for establishing the chronic
population adjusted dose (cPAD) for
pyrimethanil. The cPAD will be
protective of any potential cancer and
non-cancer effects from exposure to
pyrimethanil. At this time, there is less
concern for the lack of a repeat mouse
carcinogenicity study, since no
toxicologically significant effects were
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noted up to the highest dose tested
(HDT) (254 mg/kg/day) in the existing
mouse study, and the new study will be
tested at higher doses. Consequently
EPA does not believe that the new study
will yield a POD lower than the current
POD (17 mg/kg/day) used for risk
assessment.
Signs of potential neurotoxicity
(ataxia, decreased motor activity,
decreased body temperature, decreased
hind limb grip strength in males, and
dilated pupils in females) were observed
at the HDT (1,000 mg/kg/day) in the
acute neurotoxicity study in rats. No
signs of neurotoxicity were evident at
doses up to 392 mg/kg/day in the
subchronic neurotoxicity study in rats;
and there was no evidence of
neuropathology in either the acute or
subchronic neurotoxicity study or in
any of the subchronic and chronic
toxicity studies in mice, rats and dogs.
There was no quantitative or
qualitative evidence of increased
susceptibility of fetuses in the
developmental toxicity studies in rats
and rabbits or of offspring in the 2–
generation reproduction toxicity study
in rats. In the rat developmental toxicity
study, maternal effects (decreased body
weight and weight gain) and fetal effects
(decreases in mean litter weight and
mean fetal weight) were observed at the
same dose. Similarly, in the rabbit
developmental toxicity study, fetal
effects (decreased body weight, weight
gain, food consumption, and production
and size of fecal pellets; increase in fetal
runts; retarded ossification; 13 thoracic
vertebrae and pairs of ribs; and deaths)
occurred at a dose that produced similar
maternal toxicity (decreased body
weight, weight gain, food consumption,
and production and size of fecal pellets,
and deaths). There were no effects on
fertility or reproduction in the 2–
generation reproduction study in rats. In
this study, adverse effects (decreased
body weight/weight gain) also occurred
at the same dose in parental animals
and pups.
Specific information on the studies
received and the nature of the adverse
effects caused by pyrimethanil as well
as the no-observed-adverse-effect-level
(NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the
toxicity studies can be found at https://
www.regulations.gov in the document
Pyrimethanil Human-Health Risk
Assessment for Proposed Uses on Stone
Fruits and Citrus Fruits, page 39 in
docket ID number EPA–HQ–OPP–2008–
0478.
B. Toxicological Endpoints
For hazards that have a threshold
below which there is no appreciable
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risk, a toxicological 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 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
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 pyrimethanil used for
human risk assessment can be found at
https://www.regulations.gov in the
document Pyrimethanil Human-Health
Risk Assessment for Proposed Uses on
Stone Fruits and Citrus Fruits, page 20
in docket ID number EPA–HQ–OPP–
2008–0478.
C. Exposure Assessment
1. Dietary exposure from food and
feed uses. In evaluating dietary
exposure to pyrimethanil, EPA
considered exposure under the
petitioned-for tolerances as well as all
existing pyrimethanil tolerances in 40
CFR 180.518. EPA assessed dietary
exposures from pyrimethanil in food as
follows:
i. Acute exposure. Quantitative acute
dietary exposure and risk assessments
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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. EPA identified such effects
for the general population (decreased
motor activity, ataxia, decreased body
temperature, hind limb grip strength,
and dilated pupils observed in the acute
neurotoxicity study) and for females 13
to 49 years old (increase in fetuses with
13 thoracic vertebrae and 13 pairs of
ribs observed in the rabbit
developmental toxicity study that are
presumed to occur after a single
exposure). The aPAD for the general
population has been established at 1
mg/kg/day; whereas, the aPAD for
females 13 to 49 years old is lower (0.45
mg/kg/day) due to the more sensitive
endpoint on which it is based.
In estimating acute dietary exposure,
EPA used food consumption
information from the United States
Department of Agriculture (USDA)
1994–1996 and 1998 Nationwide
Continuing Surveys of Food Intake by
Individuals (CSFII). As to residue levels
in food, EPA assumed that pyrimethanil
residues are present in all commodities
at tolerance levels and that 100% of all
crops are treated.
ii. Chronic exposure. In conducting
the chronic dietary exposure assessment
EPA used the food consumption data
from the USDA 1994–1996 and 1998
CSFII. As to residue levels in food, EPA
assumed that pyrimethanil residues are
present in all commodities at tolerance
levels and that 100% of all crops are
treated.
iii. Cancer. EPA classified
pyrimethanil as a Group C (possible
human) carcinogen but determined that
the chronic dietary risk assessment
based on the cPAD would be protective
of any potential cancer effects.
Therefore, a separate exposure
assessment to evaluate cancer risk is
unnecessary. The weight of the evidence
supporting this determination is
discussed in unit III.A.
iv. Anticipated residue and percent
crop treated (PCT) information. EPA did
not use anticipated residue or PCT
information in the dietary assessment
for pyrimethanil. Tolerance level
residues and 100 PCT were assumed for
all food commodities.
2. Dietary exposure from drinking
water. The Agency used screening level
water exposure models in the dietary
exposure analysis and risk assessment
for pyrimethanil in drinking water.
These simulation models take into
account data on the physical, chemical,
and fate/transport characteristics of
pyrimethanil. Further information
regarding EPA drinking water models
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used in pesticide exposure assessment
can be found at https://www.epa.gov/
oppefed1/models/water/index.htm.
Based on 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
pyrimethanil for acute exposures are
estimated to be 37.8 parts per billion
(ppb) for surface water and 4.8 ppb for
ground water. EDWCs of pyrimethanil
for chronic exposures for non-cancer
assessments are estimated to be 5.1 ppb
for surface water and 4.8 ppb for ground
water.
Modeled estimates of drinking water
concentrations were directly entered
into the dietary exposure model. For
acute dietary risk assessment, the water
concentration value of 37.8 ppb was
used to assess the contribution to
drinking water. For chronic dietary risk
assessment, the water concentration of
value 5.1 ppb was used to assess the
contribution to drinking 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).
Pyrimethanil is not registered for any
specific use patterns that would result
in residential exposure.
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 pyrimethanil to
share a common mechanism of toxicity
with any other substances, and
pyrimethanil does not appear to
produce a toxic metabolite produced by
other substances. For the purposes of
this tolerance action, therefore, EPA has
assumed that pyrimethanil does not
have a common mechanism of toxicity
with other substances. For information
regarding EPA’s efforts to determine
which chemicals have a common
mechanism of toxicity and to evaluate
the cumulative effects of such
chemicals, see EPA’s website at https://
www.epa.gov/pesticides/cumulative.
D. Safety Factor for Infants and
Children
1. In general. Section 408(b)(2)(c) of
FFDCA provides that EPA shall apply
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an additional tenfold (10X) margin of
safety for infants and children in the
case of threshold effects to account for
prenatal and postnatal toxicity and the
completeness of the database on toxicity
and exposure unless EPA determines
based on reliable data that a different
margin of safety will be safe for infants
and children. This additional margin of
safety is commonly referred to as the
Food Quality Protection Act of 1996
(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 prenatal and postnatal toxicology
database for pyrimethanil includes rat
and rabbit developmental toxicity
studies and a 2–generation reproduction
toxicity study in rats. As discussed in
unit III.A., there was no evidence of
increased quantitative or qualitative
susceptibility of fetuses or offspring
following exposure to pyrimethanil in
these studies.
3. Conclusion. EPA has determined
that reliable data show the safety of
infants and children would be
adequately protected if the FQPA SF
were reduced to 1X. That decision is
based on the following findings:
i. The toxicity database for
pyrimethanil is adequate to assess the
prenatal and postnatal toxicity of
pyrimethanil. In accordance with 40
CFR part 158’s toxicological data
requirements, an immunotoxicity
testing study (OPPTS Guideline
870.7800) is required for pyrimethanil.
The evidence for immunotoxicity in the
existing database is limited to a slight
decrease in thymus weight observed at
the HDT (529 mg/kg/day) in the
subchronic study in rats. There were no
corroborative histopathological findings
noted in the thymus in this study, and
there were no effects on the thymus in
the chronic/carcinogenicity study in rats
at doses up to and including 221 mg/kg/
day or in any other study with
pyrimethanil. Since the observed
thymus weight increase is an isolated
finding, EPA does not believe that
conducting immunotoxicity testing will
result in a POD lower than the POD
already selected for evaluating chronic
exposures to pyrimethanil (17 mg/kg/
day), and an additional database UF is
not needed to account for potential
immunotoxicity.
ii. Although there were signs of
potential neurotoxicity (ataxia,
decreased motor activity, decreased
body temperature, decreased hind limb
grip strength in males, and dilated
pupils in females) observed at the HDT
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(1,000 mg/kg/day) in the acute
neurotoxicity study, there were no signs
of neurotoxicity at doses up to 392 mg/
kg/day in the subchronic neurotoxicity
study; and there was no evidence of
neuropathology in either the acute or
subchronic neurotoxicity study or in
any of the subchronic and chronic
toxicity studies in mice, rats and dogs.
Based on these findings, EPA has
determined that there is no need for a
developmental neurotoxicity study or
additional UFs to account for
neurotoxicity.
iii. There is no evidence that
pyrimethanil results in increased
susceptibility in in utero rats or rabbits
in the prenatal developmental studies or
in offspring in the 2–generation
reproduction study. There are no
residual uncertainties for prenatal and/
or postnatal toxicity.
iv. There are no residual uncertainties
identified in the exposure databases.
The dietary food exposure assessments
were performed based on 100 PCT and
tolerance-level residues. EPA made
conservative (protective) assumptions in
the ground and surface water modeling
used to assess exposure to pyrimethanil
in drinking water. Pyrimethanil is not
registered for any uses that would result
in residential exposures to the pesticide.
These assessments will not
underestimate the exposure and risks
posed by pyrimethanil.
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. Using the exposure assumptions
discussed in this unit for acute
exposure, EPA performed two different
acute risk assessments–one focusing on
females 13 to 49 years old and designed
to protect against prenatal effects and
the other focusing on acute effects
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relevant to all other population groups.
For females 13 to 49 years old, the acute
dietary exposure to pyrimethanil from
food and water will occupy 13% of the
aPAD addressing prenatal effects. As to
acute effects other than prenatal effects,
the acute dietary exposure to
pyrimethanil from food and water will
occupy 35% of the aPAD for infants less
than 1–year old, the population group
with the highest estimated acute dietary
exposure to pyrimethanil.
2. Chronic risk. Using the exposure
assumptions described in this unit for
chronic exposure, EPA has concluded
that chronic exposure to pyrimethanil
from food and water will utilize 63% of
the cPAD for children 1 to 2 years old,
the population group receiving the
greatest exposure. There are no
residential uses for pyrimethanil.
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). Pyrimethanil is not
registered for any use patterns that
would result in residential exposure.
Therefore, the short-term aggregate risk
is the sum of the risk from exposure to
pyrimethanil through food and water
and will not be greater than the chronic
aggregate risk.
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).
Pyrimethanil 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 pyrimethanil 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. The Agency has determined
that the chronic risk assessment based
on the established cPAD is protective of
potential cancer effects from exposure to
pyrimethanil. Based on the results of the
chronic risk assessment discussed in
Unit III.E.2. EPA concludes that
pyrimethanil is not expected to pose a
cancer risk.
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 pyrimethanil
residues.
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IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology
(High Performance Liquid
Chromatography (HPLC)) 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
Codex maximum residue limits
(MRLs) have been established for
pyrimethanil per se in/on plant
commodities associated with this
petition, including citrus fruit at 7 ppm
(postharvest); cherry (postharvest),
peach and nectarine at 4 ppm; apricot
at 3 ppm; and plum at 2 ppm. Due to
differences in application rates and use
patterns, harmonization of U.S.
tolerances with the lower Codex MRLs
is not possible at this time.
C. Revisions to Petitioned-For
Tolerances
IR-4 petitioned for tolerances for
residues of pyrimethanil on ‘‘fruit,
citrus, (except lemon), group 10,
(postharvest)’’ and on ‘‘lemon.’’ EPA
revised the group tolerance to read
‘‘fruit, citrus, group 10, except lemon,
postharvest’’ to agree with the accepted
nomenclature in the Agency’s Food and
Feed Vocabulary Database. The
tolerance for lemon was revised to read
‘‘lemon, preharvest and postharvest’’ to
comply with the regulation at 40 CFR
180.1(h), which requires EPA to specify
those tolerances intended to cover
postharvest use of a pesticide.
V. Conclusion
Therefore, tolerances are established
for residues of pyrimethanil, 4,6dimethyl-N-phenyl-2-pyrimidinamine,
in or on fruit, citrus, group 10, except
lemon, postharvest at 10 ppm; fruit,
stone, group 12 at 10 ppm; and lemon,
preharvest and postharvest at 11 ppm.
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,
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32447
entitled Actions Concerning Regulations
That Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May
22, 2001) or Executive Order 13045,
entitled Protection of Children from
Environmental Health Risks and Safety
Risks (62 FR 19885, April 23, 1997).
This final rule does not contain any
information collections subject to OMB
approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et
seq., nor does it require any special
considerations under Executive Order
12898, entitled Federal Actions to
Address Environmental Justice in
Minority Populations and Low-Income
Populations (59 FR 7629, February 16,
1994).
Since tolerances and exemptions that
are established on the basis of a petition
under section 408(d) of FFDCA, such as
the tolerance in this final rule, do not
require the issuance of a proposed rule,
the requirements of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
This final rule directly regulates
growers, food processors, food handlers,
and food retailers, not States or tribes,
nor does this action alter the
relationships or distribution of power
and responsibilities established by
Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such,
the Agency has determined that this
action will not have a substantial direct
effect on States or tribal governments,
on the relationship between the national
government and the States or tribal
governments, or on the distribution of
power and responsibilities among the
various levels of government or between
the Federal Government and Indian
tribes. Thus, the Agency has determined
that Executive Order 13132, entitled
Federalism (64 FR 43255, August 10,
1999) and Executive Order 13175,
entitled Consultation and Coordination
with Indian Tribal Governments (65 FR
67249, November 9, 2000) do not apply
to this final rule. In addition, this final
rule does not impose any enforceable
duty or contain any unfunded mandate
as described under Title II of the
Unfunded Mandates Reform Act of 1995
(UMRA) (Public Law 104–4).
This action does not involve any
technical standards that would require
Agency consideration of voluntary
consensus standards pursuant to section
12(d) of the National Technology
Transfer and Advancement Act of 1995
(NTTAA), Public Law 104–113, section
12(d) (15 U.S.C. 272 note).
VII. Congressional Review Act
The Congressional Review Act, 5
U.S.C. 801 et seq., generally provides
that before a rule may take effect, the
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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: June 26, 2009.
Lois Rossi,
Director, Registration Division, Office of
Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
■
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.
2. The table in paragraph (a)(1) of
§ 180.518 is amended by removing the
commodities ‘‘Fruit, citrus, group 10
postharvest’’ and ‘‘Fruit, stone, group
12, except cherry’’ and alphabetically
adding the following commodities to
read as follows:
sroberts on DSKD5P82C1PROD with RULES
■
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
SUPPLEMENTARY INFORMATION:
[EPA–HQ–OPP–2008–0731; FRL–8423–5]
I. General Information
Cyazofamid; Pesticide Tolerances
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.
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
SUMMARY: This regulation establishes
tolerances for combined residues of
cyazofamid and its metabolite, CCIM,
expressed as cyazofamid in or on
fruiting vegetable group 8 and okra.
Additionally, it establishes a tolerance
with regional restrictions in or on grape.
Finally, this regulation removes the
established grape import and tomato
tolerances, as a regional tolerance on
grape and fruiting vegetable group
tolerance replaces them, respectively.
Interregional Research Project Number 4
(IR-4) requested these tolerances under
the Federal Food, Drug, and Cosmetic
Act (FFDCA).
DATES: This regulation is effective July
8, 2009. Objections and requests for
hearings must be received on or before
September 8, 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).
EPA has established a
docket for this action under docket
identification (ID) number EPA–HQ–
OPP–2008–0731. 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,
§ 180.518 Pyrimethanil; tolerances for
e.g., Confidential Business Information
residues.
(CBI) or other information whose
(a)
*
*
*
disclosure is restricted by statute.
Certain other material, such as
(1)
*
*
*
copyrighted material, is not placed on
the Internet and will be publicly
Parts per
Commodity
available only in hard copy form.
million
Publicly available docket materials are
*
*
*
*
*
available in the electronic docket at
Fruit, citrus, group 10, except
https://www.regulations.gov, or, if only
lemon, postharvest ................
10 available in hard copy, at the OPP
*
*
*
*
*
Regulatory Public Docket in Rm. S–
Fruit, stone, group 12 ...............
10 4400, One Potomac Yard (South Bldg.),
*
*
*
*
*
2777 S. Crystal Dr., Arlington, VA. The
Lemon, preharvest and
Docket Facility is open from 8:30 a.m.
postharvest ............................
11
to 4 p.m., Monday through Friday,
*
*
*
*
*
excluding legal holidays. The Docket
Facility telephone number is (703) 305–
*
*
*
*
*
5805.
[FR Doc. E9–15942 Filed 7–7–09; 8:45 am]
FOR FURTHER INFORMATION CONTACT:
Laura Nollen, Registration Division
BILLING CODE 6560–50–S
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
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16:30 Jul 07, 2009
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DC 20460–0001; telephone number:
(703) 305–7390; e-mail address:
nollen.laura@epa.gov.
ADDRESSES:
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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.
To access the OPPTS Harmonized
Guidelines referenced in this document,
go directly to the guidelines at https://
www.epa.gpo/opptsfrs/home/
guidelin.htm.
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
E:\FR\FM\08JYR1.SGM
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Agencies
[Federal Register Volume 74, Number 129 (Wednesday, July 8, 2009)]
[Rules and Regulations]
[Pages 32443-32448]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-15942]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2008-0478; FRL-8423-6]
Pyrimethanil; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation replaces existing tolerances for residues of
pyrimethanil on fruit, citrus, group 10 postharvest; and fruit, stone,
group 12, except cherry with tolerances for residues of pyrimethanil in
or on fruit, citrus, group 10, except lemon, postharvest; fruit, stone,
group 12; and lemon, preharvest and postharvest. Interregional Research
Project Number 4 (IR-4) requested these tolerances under the Federal
Food, Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective July 8, 2009. Objections and
requests for hearings must be received on or before September 8, 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-2008-0478. 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: Susan Stanton, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 305-5218; e-mail address: stanton.susan@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. To access the OPPTS Harmonized
Guidelines referenced in this document, go directly to the guidelines
at https://www.epa.gpo/opptsfrs/home/guidelin.htm.
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
[[Page 32444]]
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-2008-0478 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 September 8, 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-2008-0478, by one of the following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is (703) 305-5805.
II. Petition for Tolerance
In the Federal Register of July 9, 2008 (73 FR 39289) (FRL-8371-2),
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 8E7353)
by IR-4, 500 College Road East, Suite 201W, Princeton, NJ 08540. The
petition requested that 40 CFR 180.518 be amended by establishing
tolerances for residues of the fungicide pyrimethanil, 4,6-dimethyl-N-
phenyl-2-pyrimidinamine, in or on fruit, citrus, (except lemon), group
10 (postharvest) at 10 parts per million (ppm); lemon at 11 ppm; and
fruit, stone, group 12 at 10 ppm; and removing existing tolerances for
residues of pyrimethanil on fruit, citrus, group 10 postharvest at 10
ppm; and fruit stone, group 12, except cherry at 3.0 ppm. That notice
referenced a summary of the petition prepared by Bayer CropScience, the
registrant, on behalf of IR-4, which is available to the public in the
docket, https://www.regulations.gov. There were no comments received in
response to the notice of filing.
Based upon review of the data supporting the petition, EPA has made
minor changes to the citrus commodity definitions. The reason for these
changes is explained in Unit IV.C.
III. Aggregate Risk Assessment and Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
.''
Consistent with section 408(b)(2)(D) of FFDCA, and the factors
specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure for the petitioned-for
tolerances for residues of pyrimethanil on fruit, citrus, group 10,
except lemon, postharvest at 11 ppm; fruit, stone, group 12 at 10 ppm;
and lemon, preharvest and postharvest at 11 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 its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children.
Pyrimethanil is of low acute toxicity by the oral, inhalation, and
dermal routes of exposure. It is slightly irritating to the eyes and
non-irritating to the skin in rabbit studies. Pyrimethanil is not a
dermal sensitizer. Subchronic and chronic repeated oral toxicity
studies in rats, mice, and dogs primarily resulted in decreased body
weight and body-weight gains, often accompanied by decreased food
consumption. The major target organs in rats and mice were the liver
and thyroid. In subchronic studies in rats and mice, liver toxicity was
manifested as increased absolute and relative liver weights.
Histopathological changes in the liver were primarily associated with
increased evidence of hypertrophy in centrilobular hepatocytes. In a
subchronic toxicity study in mice, increases in absolute thyroid weight
were observed, associated with exfoliative necrosis and pigmentation of
follicular cells. In a subchronic toxicity study in rats, thyroid
effects were manifested as an increased incidence and severity of
follicular epithelial hypertrophy and follicular epithelial brown
pigment.
EPA classified pyrimethanil as a Group C (possible human)
carcinogen, based on an increased incidence of thyroid follicular cell
tumors observed in the chronic/carcinogenicity study in rats. There was
no evidence of carcinogenicity in mice; however, the dosing in this
study was not considered to be adequate to assess the potential
carcinogenicity. Therefore, EPA is requesting a repeat of the mouse
carcinogenicity study. Based on the presence of thyroid tumors in rats,
EPA has determined that a margin of exposure (MOE) approach is
appropriate for quantification of risk. This determination is based on
evidence that pyrimethanil appears to induce thyroid tumors through a
disruption in the thyroid-pituitary status and thus may have a
threshold for tumor development. This decision was supported by the
weight of the evidence, considering the neoplastic, related
nonneoplastic and/or hormonal effects in the male rat thyroid and
liver. A point of departure (POD) of 17 milligrams/kilograms/day (mg/
kg/day), based on the thyroid precursor lesions is used for
establishing the chronic population adjusted dose (cPAD) for
pyrimethanil. The cPAD will be protective of any potential cancer and
non-cancer effects from exposure to pyrimethanil. At this time, there
is less concern for the lack of a repeat mouse carcinogenicity study,
since no toxicologically significant effects were
[[Page 32445]]
noted up to the highest dose tested (HDT) (254 mg/kg/day) in the
existing mouse study, and the new study will be tested at higher doses.
Consequently EPA does not believe that the new study will yield a POD
lower than the current POD (17 mg/kg/day) used for risk assessment.
Signs of potential neurotoxicity (ataxia, decreased motor activity,
decreased body temperature, decreased hind limb grip strength in males,
and dilated pupils in females) were observed at the HDT (1,000 mg/kg/
day) in the acute neurotoxicity study in rats. No signs of
neurotoxicity were evident at doses up to 392 mg/kg/day in the
subchronic neurotoxicity study in rats; and there was no evidence of
neuropathology in either the acute or subchronic neurotoxicity study or
in any of the subchronic and chronic toxicity studies in mice, rats and
dogs.
There was no quantitative or qualitative evidence of increased
susceptibility of fetuses in the developmental toxicity studies in rats
and rabbits or of offspring in the 2-generation reproduction toxicity
study in rats. In the rat developmental toxicity study, maternal
effects (decreased body weight and weight gain) and fetal effects
(decreases in mean litter weight and mean fetal weight) were observed
at the same dose. Similarly, in the rabbit developmental toxicity
study, fetal effects (decreased body weight, weight gain, food
consumption, and production and size of fecal pellets; increase in
fetal runts; retarded ossification; 13 thoracic vertebrae and pairs of
ribs; and deaths) occurred at a dose that produced similar maternal
toxicity (decreased body weight, weight gain, food consumption, and
production and size of fecal pellets, and deaths). There were no
effects on fertility or reproduction in the 2-generation reproduction
study in rats. In this study, adverse effects (decreased body weight/
weight gain) also occurred at the same dose in parental animals and
pups.
Specific information on the studies received and the nature of the
adverse effects caused by pyrimethanil as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at https://www.regulations.gov in the document Pyrimethanil Human-Health Risk
Assessment for Proposed Uses on Stone Fruits and Citrus Fruits, page 39
in docket ID number EPA-HQ-OPP-2008-0478.
B. Toxicological Endpoints
For hazards that have a threshold below which there is no
appreciable risk, a toxicological 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 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 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 pyrimethanil used for
human risk assessment can be found at https://www.regulations.gov in the
document Pyrimethanil Human-Health Risk Assessment for Proposed Uses on
Stone Fruits and Citrus Fruits, page 20 in docket ID number EPA-HQ-OPP-
2008-0478.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to pyrimethanil, EPA considered exposure under the petitioned-
for tolerances as well as all existing pyrimethanil tolerances in 40
CFR 180.518. EPA assessed dietary exposures from pyrimethanil 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. EPA identified such effects
for the general population (decreased motor activity, ataxia, decreased
body temperature, hind limb grip strength, and dilated pupils observed
in the acute neurotoxicity study) and for females 13 to 49 years old
(increase in fetuses with 13 thoracic vertebrae and 13 pairs of ribs
observed in the rabbit developmental toxicity study that are presumed
to occur after a single exposure). The aPAD for the general population
has been established at 1 mg/kg/day; whereas, the aPAD for females 13
to 49 years old is lower (0.45 mg/kg/day) due to the more sensitive
endpoint on which it is based.
In estimating acute dietary exposure, EPA used food consumption
information from the United States Department of Agriculture (USDA)
1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by
Individuals (CSFII). As to residue levels in food, EPA assumed that
pyrimethanil residues are present in all commodities at tolerance
levels and that 100% of all crops are treated.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA 1994-1996
and 1998 CSFII. As to residue levels in food, EPA assumed that
pyrimethanil residues are present in all commodities at tolerance
levels and that 100% of all crops are treated.
iii. Cancer. EPA classified pyrimethanil as a Group C (possible
human) carcinogen but determined that the chronic dietary risk
assessment based on the cPAD would be protective of any potential
cancer effects. Therefore, a separate exposure assessment to evaluate
cancer risk is unnecessary. The weight of the evidence supporting this
determination is discussed in unit III.A.
iv. Anticipated residue and percent crop treated (PCT) information.
EPA did not use anticipated residue or PCT information in the dietary
assessment for pyrimethanil. Tolerance level residues and 100 PCT were
assumed for all food commodities.
2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for pyrimethanil in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of pyrimethanil. Further information regarding EPA
drinking water models
[[Page 32446]]
used in pesticide exposure assessment can be found at https://www.epa.gov/oppefed1/models/water/index.htm.
Based on 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
pyrimethanil for acute exposures are estimated to be 37.8 parts per
billion (ppb) for surface water and 4.8 ppb for ground water. EDWCs of
pyrimethanil for chronic exposures for non-cancer assessments are
estimated to be 5.1 ppb for surface water and 4.8 ppb for ground water.
Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For acute dietary risk
assessment, the water concentration value of 37.8 ppb was used to
assess the contribution to drinking water. For chronic dietary risk
assessment, the water concentration of value 5.1 ppb was used to assess
the contribution to drinking 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). Pyrimethanil is not
registered for any specific use patterns that would result in
residential exposure.
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 pyrimethanil to share a common mechanism of
toxicity with any other substances, and pyrimethanil does not appear to
produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
pyrimethanil does not have a common mechanism of toxicity with other
substances. For information regarding EPA's efforts to determine which
chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see EPA's website at https://www.epa.gov/pesticides/cumulative.
D. Safety Factor for Infants and Children
1. In general. Section 408(b)(2)(c) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the Food Quality
Protection Act of 1996 (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 prenatal and postnatal
toxicology database for pyrimethanil includes rat and rabbit
developmental toxicity studies and a 2-generation reproduction toxicity
study in rats. As discussed in unit III.A., there was no evidence of
increased quantitative or qualitative susceptibility of fetuses or
offspring following exposure to pyrimethanil in these studies.
3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1X. That decision is based on the following
findings:
i. The toxicity database for pyrimethanil is adequate to assess the
prenatal and postnatal toxicity of pyrimethanil. In accordance with 40
CFR part 158's toxicological data requirements, an immunotoxicity
testing study (OPPTS Guideline 870.7800) is required for pyrimethanil.
The evidence for immunotoxicity in the existing database is limited to
a slight decrease in thymus weight observed at the HDT (529 mg/kg/day)
in the subchronic study in rats. There were no corroborative
histopathological findings noted in the thymus in this study, and there
were no effects on the thymus in the chronic/carcinogenicity study in
rats at doses up to and including 221 mg/kg/day or in any other study
with pyrimethanil. Since the observed thymus weight increase is an
isolated finding, EPA does not believe that conducting immunotoxicity
testing will result in a POD lower than the POD already selected for
evaluating chronic exposures to pyrimethanil (17 mg/kg/day), and an
additional database UF is not needed to account for potential
immunotoxicity.
ii. Although there were signs of potential neurotoxicity (ataxia,
decreased motor activity, decreased body temperature, decreased hind
limb grip strength in males, and dilated pupils in females) observed at
the HDT (1,000 mg/kg/day) in the acute neurotoxicity study, there were
no signs of neurotoxicity at doses up to 392 mg/kg/day in the
subchronic neurotoxicity study; and there was no evidence of
neuropathology in either the acute or subchronic neurotoxicity study or
in any of the subchronic and chronic toxicity studies in mice, rats and
dogs. Based on these findings, EPA has determined that there is no need
for a developmental neurotoxicity study or additional UFs to account
for neurotoxicity.
iii. There is no evidence that pyrimethanil results in increased
susceptibility in in utero rats or rabbits in the prenatal
developmental studies or in offspring in the 2-generation reproduction
study. There are no residual uncertainties for prenatal and/or
postnatal toxicity.
iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100 PCT and tolerance-level residues. EPA made conservative
(protective) assumptions in the ground and surface water modeling used
to assess exposure to pyrimethanil in drinking water. Pyrimethanil is
not registered for any uses that would result in residential exposures
to the pesticide. These assessments will not underestimate the exposure
and risks posed by pyrimethanil.
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. Using the exposure assumptions discussed in this unit
for acute exposure, EPA performed two different acute risk assessments-
one focusing on females 13 to 49 years old and designed to protect
against prenatal effects and the other focusing on acute effects
[[Page 32447]]
relevant to all other population groups. For females 13 to 49 years
old, the acute dietary exposure to pyrimethanil from food and water
will occupy 13% of the aPAD addressing prenatal effects. As to acute
effects other than prenatal effects, the acute dietary exposure to
pyrimethanil from food and water will occupy 35% of the aPAD for
infants less than 1-year old, the population group with the highest
estimated acute dietary exposure to pyrimethanil.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
pyrimethanil from food and water will utilize 63% of the cPAD for
children 1 to 2 years old, the population group receiving the greatest
exposure. There are no residential uses for pyrimethanil.
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). Pyrimethanil
is not registered for any use patterns that would result in residential
exposure. Therefore, the short-term aggregate risk is the sum of the
risk from exposure to pyrimethanil through food and water and will not
be greater than the chronic aggregate risk.
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). Pyrimethanil 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 pyrimethanil 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. The Agency has
determined that the chronic risk assessment based on the established
cPAD is protective of potential cancer effects from exposure to
pyrimethanil. Based on the results of the chronic risk assessment
discussed in Unit III.E.2. EPA concludes that pyrimethanil is not
expected to pose a cancer risk.
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 pyrimethanil residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (High Performance Liquid
Chromatography (HPLC)) 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
Codex maximum residue limits (MRLs) have been established for
pyrimethanil per se in/on plant commodities associated with this
petition, including citrus fruit at 7 ppm (postharvest); cherry
(postharvest), peach and nectarine at 4 ppm; apricot at 3 ppm; and plum
at 2 ppm. Due to differences in application rates and use patterns,
harmonization of U.S. tolerances with the lower Codex MRLs is not
possible at this time.
C. Revisions to Petitioned-For Tolerances
IR-4 petitioned for tolerances for residues of pyrimethanil on
``fruit, citrus, (except lemon), group 10, (postharvest)'' and on
``lemon.'' EPA revised the group tolerance to read ``fruit, citrus,
group 10, except lemon, postharvest'' to agree with the accepted
nomenclature in the Agency's Food and Feed Vocabulary Database. The
tolerance for lemon was revised to read ``lemon, preharvest and
postharvest'' to comply with the regulation at 40 CFR 180.1(h), which
requires EPA to specify those tolerances intended to cover postharvest
use of a pesticide.
V. Conclusion
Therefore, tolerances are established for residues of pyrimethanil,
4,6-dimethyl-N-phenyl-2-pyrimidinamine, in or on fruit, citrus, group
10, except lemon, postharvest at 10 ppm; fruit, stone, group 12 at 10
ppm; and lemon, preharvest and postharvest at 11 ppm.
VI. Statutory and Executive Order Reviews
This final rule establishes tolerances under section 408(d) of
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this final rule has been
exempted from review under Executive Order 12866, this final rule is
not subject to Executive Order 13211, entitled Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
Protection of Children from Environmental Health Risks and Safety Risks
(62 FR 19885, April 23, 1997). This final rule does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any
special considerations under Executive Order 12898, entitled Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under section 408(d) of FFDCA, such as the tolerance in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled Federalism (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Public Law 104-4).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note).
VII. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the
[[Page 32448]]
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: June 26, 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. The table in paragraph (a)(1) of Sec. 180.518 is amended by
removing the commodities ``Fruit, citrus, group 10 postharvest'' and
``Fruit, stone, group 12, except cherry'' and alphabetically adding the
following commodities to read as follows:
Sec. 180.518 Pyrimethanil; tolerances for residues.
(a) * * *
(1) * * *
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Fruit, citrus, group 10, except lemon, postharvest......... 10
* * * * *
Fruit, stone, group 12..................................... 10
* * * * *
Lemon, preharvest and postharvest.......................... 11
* * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. E9-15942 Filed 7-7-09; 8:45 am]
BILLING CODE 6560-50-S