Cyprodinil; Pesticide Tolerances, 5691-5696 [2011-2157]
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5691
Federal Register / Vol. 76, No. 22 / Wednesday, February 2, 2011 / Rules and Regulations
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: January 24, 2011.
Lois Rossi,
Director, Registration Division, Office of
Pesticide Programs.
§ 180.910 Inert ingredients used pre- and
post-harvest; exemptions from the
requirement of a tolerance.
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
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2. In the table to § 180.910 add
alphabetically a new inert ingredient to
read as follows:
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Inert ingredients
Limits
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Isobutane (CAS Reg. No. 75–28–5) .......................................................................
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None ......................
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3. In the table to § 180.930, add
alphabetically a new inert ingredient to
read as follows:
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Uses
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Propellant.
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Isobutane (CAS Reg. No. 75–28–5) .......................................................................
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None ......................
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[FR Doc. 2011–2265 Filed 2–1–11; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2010–0385; FRL–8860–3]
Cyprodinil; Pesticide Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation amends
tolerances for residues of cyprodinil in
or on fruit, pome, group 11 and apple
wet pomace. This regulation also
establishes tolerances for meat
byproducts of cattle, goats, horses and
sheep. Syngenta Crop Protection
requested these tolerances under the
Federal Food, Drug, and Cosmetic Act
(FFDCA).
DATES: This regulation is effective
February 2, 2011. Objections and
requests for hearings must be received
on or before April 4, 2011, 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
SUMMARY:
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§ 180.930 Inert ingredients applied to
animals; exemptions from the requirement
of a tolerance.
Limits
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Inert ingredients
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Authority: 21 U.S.C. 321(q), 346a and 371.
Therefore, 40 CFR chapter I is
amended as follows:
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Lisa
Jones, Registration Division (7505P),
Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
(703) 308–9424; e-mail address:
jones.lisa@epa.gov.
FOR FURTHER INFORMATION CONTACT:
SUPPLEMENTARY INFORMATION:
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Propellant.
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identification (ID) number EPA–HQ–
OPP–2010–0385. 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
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.
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B. How can I get electronic access to
other related information?
You may access a frequently updated
electronic version of EPA’s tolerance
regulations at 40 CFR part 180 through
the Government Printing Office’s e-CFR
site at https://www.gpoaccess.gov/ecfr.
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C. How can I file an objection or hearing
request?
Under FFDCA section 408(g), 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–2010–0385 in the subject line on
the first page of your submission. All
objections and requests for a hearing
must be in writing, and must be
received by the Hearing Clerk on or
before April 4, 2011. Addresses for mail
and hand delivery of objections and
hearing requests are provided in 40 CFR
178.25(b).
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. Information not marked
confidential pursuant to 40 CFR part 2
may be disclosed publicly by EPA
without prior notice. Submit a copy of
your non-CBI objection or hearing
request, identified by docket ID number
EPA–HQ–OPP–2010–0385, 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. Summary of Petitioned-For
Tolerance
In the Federal Register of June 8, 2010
(75 FR 32466) (FRL–8827–5), EPA
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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 0F7696) by
Syngenta Crop Protection, P.O. Box
18300, Greensboro, NC 27409. The
petition requested that 40 CFR 180.532
be amended by raising tolerances for
residues of the fungicide cyprodinil, in
or on fruit, pome, group 11 from 0.1
parts per million (ppm) to 1.7 ppm. That
notice referenced a summary of the
petition prepared by Syngenta Crop
Protection, the registrant, which is
available 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
increased the tolerance for apple, wet
pomace from 0.15 ppm to 4.6 ppm. EPA
has also established tolerances for meat
byproducts of cattle, goats, horses, and
sheep at 0.02 ppm. The reason for this
change 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 cyprodinil
including exposure resulting from the
tolerances established by this action.
EPA’s assessment of exposures and risks
associated with cyprodinil follows.
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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.
Cyprodinil has low acute toxicity via
the oral, dermal, and inhalation routes.
Cyprodinil is mildly irritating to the
eyes and negligibly irritating to the skin.
It is a dermal sensitizer. The major
target organs of cyprodinil are the liver
in both rats and mice and the kidney in
rats. Liver effects observed consistently
in subchronic and chronic studies in
rats and mice include increased liver
weights, increases in serum clinical
chemistry parameters associated with
adverse effects on liver function,
hepatocyte hypertrophy, and
hepatocellular necrosis. Adverse kidney
effects include tubular lesions and
inflammation following subchronic
exposure of male rats. The
hematopoietic system also appeared to
be a target of cyprodinil, causing mild
anemia in rats exposed subchronically.
Chronic effects in dogs were limited to
decreased body-weight gain, decreased
food consumption and decreased food
efficiency. There was no evidence of
increased susceptibility in the
developmental rat or rabbit study
following in utero exposure or in the 2generation reproduction study following
prenatal or postnatal exposure. There
was no evidence of neuropathological or
other neurological effects in the
available subchronic neurotoxicity
study. The results of a preliminary
immunotoxicity study provided no
evidence for immunotoxicity. There was
no evidence of carcinogenic potential in
either the rat chronic toxicity/
carcinogenicity or mouse
carcinogenicity studies.
B. Toxicological Points of Departure/
Levels of Concern
Once a pesticide’s toxicological
profile is determined, EPA identifies
toxicological points of departure (POD)
and levels of concern (LOC) to use in
evaluating the risk posed by human
exposure to the pesticide. For hazards
that have a threshold below which there
is no appreciable risk, the toxicological
POD is used as the basis for derivation
of reference values for risk assessment.
PODs are developed based on a careful
analysis of the doses in each
toxicological study to determine the
dose at which no adverse effects are
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observed (the NOAEL) and the lowest
dose at which adverse effects of concern
are identified (the LOAEL). Uncertainty/
safety factors are used in conjunction
with the POD to calculate a safe
exposure level—generally referred to as
a population-adjusted dose (PAD) or a
reference dose (RfD)—and a safe margin
of exposure (MOE). 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
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 cyprodinil used for
human risk assessment is discussed in
Unit III.A of the final rule published in
the Federal Register of April 28, 2010
(75 FR 22242) (FRL–8818–8).
C. Exposure Assessment
1. Dietary exposure from food and
feed uses. In evaluating dietary
exposure to cyprodinil, EPA considered
exposure under the petitioned-for
tolerances as well as all existing
cyprodinil tolerances in 40 CFR
180.532. EPA assessed dietary
exposures from cyprodinil 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. Such effects were identified
for cyprodinil. In estimating acute
dietary exposure, EPA used the Dietary
Exposure Evaluation Model–Food
Consumption Intake Database (DEEM–
FCIDTM, Version 2.03), which uses food
consumption data from the U. S.
Department of Agriculture (USDA)
Continuing Surveys of Food Intakes by
Individuals (CSFII) from 1994–1996 and
1998. As to residue levels in food, EPA
performed a screening level acute
dietary exposure analysis for the
population subgroup females 13 to 49
only. No acute endpoint was identified
for the remaining population subgroups.
Tolerance level residues and 100
percent crop treated (PCT) assumptions
were used. DEEM default and empirical
processing factors were used to modify
the tolerance values.
ii. Chronic exposure. In conducting
the chronic dietary exposure
assessment, EPA used the DEEM–
FCIDTM, Version 2.03, which uses food
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consumption data from the USDA 1994–
1996 and 1998 CSFII. A moderately
refined chronic dietary exposure
analysis was performed for the general
U.S. population and various population
subgroups. Average field trial residues
for pome fruit, tolerance level residues
for the remaining commodities, and 100
PCT assumptions were used. DEEM
default and empirical processing factors
were used.
iii. Cancer. EPA determines whether
quantitative cancer exposure and risk
assessments are appropriate for a fooduse pesticide based on the weight of the
evidence from cancer studies and other
relevant data. If quantitative cancer risk
assessment is appropriate, cancer risk
may be quantified using a linear or nonlinear approach. If sufficient
information on the carcinogenic mode
of action is available, a threshold or
non-linear approach is used and a
cancer RfD is calculated based on an
earlier non-cancer key event. If
carcinogenic mode of action data are not
available, or if the mode of action data
determine a mutagenic mode of action,
a default linear cancer slope factor
approach is utilized. Data summarized
in Table 2 of the document ‘‘Human
Health Risk—Cyprodinil Increased
Pome Fruit Tolerance’’, pp. 24 through
29, in docket ID number EPA–HQ–OPP–
2010–0385 at https://
www.regulations.gov, showed no
evidence of carcinogenic potential in
either the rat chronic toxicity/
carcinogenicity or mouse
carcinogenicity studies. EPA therefore
concluded that cyprodinil does not pose
a cancer risk to humans. Therefore a
dietary exposure assessment for the
purpose of assessing cancer risk is
unnecessary.
iv. Anticipated residue and percent
crop treated (PCT) information. Section
408(b)(2)(E) of FFDCA authorizes EPA
to use available data and information on
the anticipated residue levels of
pesticide residues in food and the actual
levels of pesticide residues that have
been measured in food. If EPA relies on
such information, EPA must require
pursuant to FFDCA section 408(f)(1)
that data be provided 5 years after the
tolerance is established, modified, or
left in effect, demonstrating that the
levels in food are not above the levels
anticipated. For the present action, EPA
will issue such data call-ins as are
required by FFDCA section 408(b)(2)(E)
and authorized under FFDCA section
408(f)(1). Data will be required to be
submitted no later than 5 years from the
date of issuance of these tolerances.
2. Dietary exposure from drinking
water. The Agency used screening level
water exposure models in the dietary
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exposure analysis and risk assessment
for cyprodinil in drinking water. These
simulation models take into account
data on the physical, chemical, and fate/
transport characteristics of cyprodinil.
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
cyprodinil for acute exposures are 34.79
parts per billion (ppb) for surface water
and 0.0861 ppb for ground water and for
chronic exposures for non-cancer
assessments are estimated to be 24.65
ppb for surface water and 0.0861 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 34.79 ppb was
used to assess the contribution to
drinking water. For chronic dietary risk
assessment, the water concentration
value of 24.65 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).
Cyprodinil 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 cyprodinil to share
a common mechanism of toxicity with
any other substances, and cyprodinil
does not appear to produce a toxic
metabolite produced by other
substances. For the purposes of this
tolerance action, therefore, EPA has
assumed that cyprodinil 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
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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 database is considered adequate for
selection of study endpoints and
determination of a dose/response to
characterize the potential prenatal or
postnatal toxicity of cyprodinil to
infants and children. No increase in
susceptibility was seen in
developmental toxicity studies in rat
and rabbit or reproductive toxicity
studies in the rat. Toxicity to offspring
was observed at dose levels the same or
greater than those causing maternal or
parental toxicity. Based on the results of
developmental and reproductive
toxicity studies, there is not a concern
for increased qualitative and/or
quantitative susceptibility following in
utero exposure to cyprodinil.
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 toxicology database for
cyprodinil is largely complete, missing
only the recently-required acute
neurotoxicity study and the functional
immunotoxicity study. EPA has
determined that an additional
uncertainty factor is not needed to
account for the lack of these studies for
the following reasons:
The functional immunotoxicity study
for cyprodinil is not expected to alter
the RfD. A preliminary immunotoxicity
study was submitted. The study did not
meet all requirements, but is considered
Upgradeable/Guideline. The registrant
must either submit a required Natural
Killer cell activity assay or provide
justification that it is not needed.
Otherwise, the results of the preliminary
study provided no evidence of
immunotoxicity. Specifically, there
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were no treatment-related effects on
absolute, adjusted, or relative spleen or
thymus weights; no effects on specific
activity or total activity of splenic IgM
antibody-forming cells to the T celldependent antigen sRBC. There is no
evidence in the other existing studies
that cyprodinil targets the immune
system. No other immunotoxicity
studies have been submitted.
The acute neurotoxicity study is not
expected to alter the RfD for cyprodinil
because the available data show no
evidence of neurotoxic potential for
cyprodinil. The NOAEL from an acute
study is unlikely to be appreciably
lower than the NOAEL of 600 mg/kg/
day from the subchronic neurotoxicity
study. Neurotoxicity was not observed
in subchronic neurotoxicity study or the
prenatal developmental toxicity studies
in rats and rabbits.
ii. A developmental neurotoxicity
study is not required. As noted, the
available data show no evidence of
neurotoxic potential for cyprodinil.
iii. There is no evidence that
cyprodinil results in increased
susceptibility in in utero rats or rabbits
in the prenatal developmental studies or
in young rats in the 2–generation
reproduction study.
iv. There are no residual uncertainties
identified in the exposure databases.
The acute dietary food exposure
assessments were performed based on
100 PCT and tolerance-level residues.
The chronic dietary food exposure
assessments were performed based on
average field trial residues for pome
fruit, tolerance level residues for the
remaining commodities, and 100 PCT
assumptions. EPA made conservative
(protective) assumptions in the ground
and surface water modeling used to
assess exposure to cyprodinil in
drinking water. These assessments will
not underestimate the exposure and
risks posed by cyprodinil.
E. Aggregate Risks and Determination of
Safety
EPA determines whether acute and
chronic dietary pesticide exposures are
safe by comparing aggregate exposure
estimates to the acute population
adjusted dose (aPAD) and chronic
population adjusted dose (cPAD). For
linear cancer risks, EPA calculates the
lifetime probability of acquiring cancer
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 appropriate
PODs to ensure that an adequate MOE
exists.
1. Acute risk. Using the exposure
assumptions discussed in this unit for
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acute exposure, the acute dietary
exposure from food and water to
cyprodinil will occupy 4% of the aPAD
for females 13 to 49 years old, the
population group receiving the greatest
exposure.
2. Chronic risk. Using the exposure
assumptions described in this unit for
chronic exposure, EPA has concluded
that chronic exposure to cyprodinil
from food and water will utilize 86% of
the cPAD for children 1 to 2 years old
the population group receiving the
greatest exposure.
3. Aggregate cancer risk for U.S.
population. Based on the lack of
evidence of carcinogenicity in two
adequate rodent carcinogenicity studies,
cyprodinil is not expected to pose a
cancer risk to humans.
4. 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 cyprodinil
residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate High Performance Liquid
Chromatography, using ultra-violet
detection (HPLC/UV) methods with
column switching (Syngenta Methods
AG–631 and AG–631B) are available for
enforcing tolerances of cyprodinil on
plant commodities. The level of
quantitation (LOQs) for these methods
range from 0.01 to 0.05 ppm depending
on the plant commodities. Method AG–
631B also contains procedures for
confirmatory analysis by gas
chromatography with nitrogen
phosphorus detection (GC/NPD).
An adequate HPLC/mass spectrometry
method (GRM010.01A) is also available
for enforcing tolerances in livestock
commodities. This method determines
residues of both parent and the
metabolite CGA–304075 (free and
conjugated), expressed as parent. The
LOQ is 0.01 ppm for each analyte for a
combined LOQ of 0.02 ppm.
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
In making its tolerance decisions, EPA
seeks to harmonize U.S. tolerances with
international standards whenever
possible, consistent with U.S. food
safety standards and agricultural
practices. EPA considers the
international maximum residue limits
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(MRLs) established by the Codex
Alimentarius Commission (Codex), as
required by FFDCA section 408(b)(4).
The Codex Alimentarius is a joint U.N.
Food and Agriculture Organization/
World Health Organization food
standards program, and it is recognized
as an international food safety
standards-setting organization in trade
agreements to which the United States
is a party. EPA may establish a tolerance
that is different from a Codex MRL;
however, FFDCA section 408(b)(4)
requires that EPA explain the reasons
for departing from the Codex level.
The Codex has established MRLs for
residues of cyprodinil in/on apple (0.05
mg/kg, the LOQ) and pear (1 mg/kg).
There is also a currently established
Canadian MRL for residues of
cyprodinil in/on pome fruit (0.1 ppm);
but none is established in Mexico. It is
not possible to harmonize with Codex
and Canadian MRLs for residues of
cyprodinil in/on pome fruit
commodities because the proposed use
in the United States results in residue
levels greater than the Codex and
Canadian MRLs due to the shorter
preharvest interval in the United States.
C. Revisions to Petitioned-For
Tolerances
Based on the submitted apple field
trial and available apple processing
data, the currently established tolerance
for residues of cyprodinil in apple wet
pomace will need to be increased from
0.15 ppm to 4.6 ppm to cover the
proposed amended uses of cyprodinil
on pome fruit. Additionally, the Agency
has determined the currently
established 0.02 ppm tolerance level for
meat byproducts of cattle, goats, horses,
and sheep are adequate but the
currently established tolerance
expression for livestock commodities
should be changed to reflect
measurements of both parent and
metabolite CGA–304075.
rmajette on DSK29S0YB1PROD with RULES
V. Conclusion
Therefore, tolerances are established
for residues of cyprodinil, in or on pome
fruit at 1.7 ppm and in apple wet
pomace at 4.6 ppm. Tolerances are also
established for cyprodinil and (free and
conjugated) CGA–304075, expressed in
parent equivalents on meat byproducts
of cattle, goats, horses, and sheep at 0.02
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
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Jkt 223001
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) (Pub. L.
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
PO 00000
Frm 00017
Fmt 4700
Sfmt 4700
Transfer and Advancement Act of 1995
(NTTAA), Public Law 104–113, section
12(d) (15 U.S.C. 272 note).
VII. Congressional Review Act
The Congressional Review Act, 5
U.S.C. 801 et seq., generally provides
that before a rule may take effect, the
agency promulgating the rule must
submit a rule report to each House of
the Congress and to the Comptroller
General of the United States. EPA will
submit a report containing this rule and
other required information to the U.S.
Senate, the U.S. House of
Representatives, and the Comptroller
General of the United States prior to
publication of this final rule in the
Federal Register. This final rule is not
a ‘‘major rule’’ as defined by 5 U.S.C.
804(2).
List of Subjects in 40 CFR Part 180
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: January 24, 2011.
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. Section 180.532 is amended by
revising paragraph (a) to read:
■
§ 180.532 Cyprodinil; tolerances for
residues.
(a) General. (1) Tolerances are
established for residues of the fungicide
cyprodinil, including its metabolites
and degradates, in or on the
commodities in the table below.
Compliance with the tolerance levels
specified below is to be determined by
measuring only cyprodinil 4cyclopropyl-6-methyl-N-phenyl-2pyrimidinamine.
Commodity
Almond ......................................
Almond, hulls ............................
Apple, wet pomace ...................
Avocado ....................................
Bean, dry ..................................
Bean, succulent ........................
Brassica, head and stem, subgroup 5A ...............................
Brassica, leafy greens, subgroup 5B ...............................
E:\FR\FM\02FER1.SGM
02FER1
Parts per
million
0.02
8.0
4.6
1.2
0.6
0.6
1.0
10.0
5696
Federal Register / Vol. 76, No. 22 / Wednesday, February 2, 2011 / Rules and Regulations
Parts per
million
Commodity
Bushberry subgroup 13B ..........
Caneberry subgroup 13A .........
Canistel .....................................
Canola, seed 1 ..........................
Citrus, dried pulp ......................
Citrus, oil ...................................
Fruit, pome ...............................
Fruit, stone ................................
Grape ........................................
Grape, raisin .............................
Herb subgroup 19A, dried, except parsley ...........................
Herb subgroup 19A, fresh, except parsley ...........................
Juneberry ..................................
Kiwifruit .....................................
Leafy greens subgroup 4A, except spinach 35 .....................
Lemon .......................................
Lime ..........................................
Lingonberry ...............................
Longan ......................................
Lychee ......................................
Mango .......................................
Onion, bulb ...............................
Onion, green .............................
Papaya ......................................
Parsley, dried leaves ................
Parsley, leaves .........................
Pistachio ...................................
Pulasan .....................................
Rambutan .................................
Salal ..........................................
Sapodilla ...................................
Sapote, black ............................
Sapote, mamey ........................
Spanish lime .............................
Star apple .................................
Strawberry ................................
Tomatillo ...................................
Tomato ......................................
Tomato, paste ...........................
Turnip, greens ..........................
Vegetable, cucurbit, group 9 ....
Vegetable, leaves of root and
tuber, group 2 .......................
Vegetable, root, except sugarbeet, subgroup 1B 41 ...........
Watercress ................................
rmajette on DSK29S0YB1PROD with RULES
1 Import
3.0
10
1.2
0.03
8.0
340
1.7
2.0
2.0
3.0
15.0
3.0
3.0
1.8
30
0.60
0.60
3.0
2.0
2.0
1.2
0.60
4.0
1.2
170
35
0.10
2.0
2.0
3.0
1.2
1.2
1.2
2.0
1.2
5.0
0.45
0.45
1.0
10.0
0.70
10
0.75
20
only.
(2) Tolerances are established for
residues of the fungicide cyprodinil,
including its metabolites and
degradates, in the commodities in the
table below. Compliance with the
tolerance levels specified below is to be
determined by measuring only the sum
of cyprodinil 4-cyclopropyl-6-methyl-Nphenyl-2-pyrimidinamine and free and
conjugated CGA–304075 4-(4cyclopropyl-6-methyl-pyrimidin-2ylamino)-phenol, calculated as the
stoichiometric equivalent of cyprodinil.
Parts per
million
Commodity
Cattle, meat byproducts .............
Goat, meat byproducts ...............
Horse, meat byproducts .............
VerDate Mar<15>2010
14:48 Feb 01, 2011
Jkt 223001
0.02
0.02
0.02
Parts per
million
Commodity
Sheep, meat byproducts ............
*
*
*
*
0.02
*
[FR Doc. 2011–2157 Filed 2–1–11; 8:45 am]
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2009–0980; FRL–8861–1]
Fluazifop-P-butyl; Pesticide Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes
tolerances for residues of fluazifop-Pbutyl in or on multiple commodities
which are identified and discussed later
in this document. Syngenta Crop
Protection, Inc., requested these
tolerances under the Federal Food,
Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective
February 2, 2011. Objections and
requests for hearings must be received
on or before April 4, 2011, and must be
filed in accordance with the instructions
provided in 40 CFR part 178 (see also
Unit I.C. of the SUPPLEMENTARY
INFORMATION).
SUMMARY:
EPA has established a
docket for this action under docket
identification (ID) number EPA–HQ–
OPP–2009–0980. 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,
ADDRESSES:
Frm 00018
Fmt 4700
SUPPLEMENTARY INFORMATION:
I. General Information
BILLING CODE 6560–50–P
PO 00000
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
(703) 305–5218; e-mail address:
stanton.susan@epa.gov.
Sfmt 4700
A. Does this action apply to me?
You may be potentially affected by
this action if you are an agricultural
producer, food manufacturer, or
pesticide manufacturer. Potentially
affected entities may include, but are
not limited to those engaged in the
following activities:
• Crop production (NAICS code 111).
• Animal production (NAICS code
112).
• Food manufacturing (NAICS code
311).
• Pesticide manufacturing (NAICS
code 32532).
This listing is not intended to be
exhaustive, but rather to provide a guide
for readers regarding entities likely to be
affected by this action. Other types of
entities not listed in this unit could also
be affected. The North American
Industrial Classification System
(NAICS) codes have been provided to
assist you and others in determining
whether this action might apply to
certain entities. If you have any
questions regarding the applicability of
this action to a particular entity, consult
the person listed under FOR FURTHER
INFORMATION CONTACT.
B. How can I get electronic access to
other related information?
You may access a frequently updated
electronic version of EPA’s tolerance
regulations at 40 CFR part 180 through
the Government Printing Office’s e-CFR
site at https://www.gpoaccess.gov/ecfr.
To access the harmonized test
guidelines referenced in this document
electronically, please go to https://
www.epa.gov/ocspp and select ‘‘Test
Methods and Guidelines.’’
C. How can I file an objection or hearing
request?
Under FFDCA section 408(g), 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–2009–0980 in the subject line on
the first page of your submission. All
objections and requests for a hearing
must be in writing, and must be
E:\FR\FM\02FER1.SGM
02FER1
Agencies
[Federal Register Volume 76, Number 22 (Wednesday, February 2, 2011)]
[Rules and Regulations]
[Pages 5691-5696]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-2157]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2010-0385; FRL-8860-3]
Cyprodinil; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation amends tolerances for residues of cyprodinil
in or on fruit, pome, group 11 and apple wet pomace. This regulation
also establishes tolerances for meat byproducts of cattle, goats,
horses and sheep. Syngenta Crop Protection requested these tolerances
under the Federal Food, Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective February 2, 2011. Objections and
requests for hearings must be received on or before April 4, 2011, 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-2010-0385. 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: Lisa Jones, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 308-9424; e-mail address: jones.lisa@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.
[[Page 5692]]
B. How can I get electronic access to other related information?
You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing Office's e-CFR site at https://www.gpoaccess.gov/ecfr.
C. How can I file an objection or hearing request?
Under FFDCA section 408(g), 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-2010-0385 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
April 4, 2011. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
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. Information not marked confidential pursuant to 40 CFR part 2
may be disclosed publicly by EPA without prior notice. Submit a copy of
your non-CBI objection or hearing request, identified by docket ID
number EPA-HQ-OPP-2010-0385, 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. Summary of Petitioned-For Tolerance
In the Federal Register of June 8, 2010 (75 FR 32466) (FRL-8827-5),
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 0F7696)
by Syngenta Crop Protection, P.O. Box 18300, Greensboro, NC 27409. The
petition requested that 40 CFR 180.532 be amended by raising tolerances
for residues of the fungicide cyprodinil, in or on fruit, pome, group
11 from 0.1 parts per million (ppm) to 1.7 ppm. That notice referenced
a summary of the petition prepared by Syngenta Crop Protection, the
registrant, which is available 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
increased the tolerance for apple, wet pomace from 0.15 ppm to 4.6 ppm.
EPA has also established tolerances for meat byproducts of cattle,
goats, horses, and sheep at 0.02 ppm. The reason for this change 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 cyprodinil including
exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with cyprodinil
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.
Cyprodinil has low acute toxicity via the oral, dermal, and
inhalation routes. Cyprodinil is mildly irritating to the eyes and
negligibly irritating to the skin. It is a dermal sensitizer. The major
target organs of cyprodinil are the liver in both rats and mice and the
kidney in rats. Liver effects observed consistently in subchronic and
chronic studies in rats and mice include increased liver weights,
increases in serum clinical chemistry parameters associated with
adverse effects on liver function, hepatocyte hypertrophy, and
hepatocellular necrosis. Adverse kidney effects include tubular lesions
and inflammation following subchronic exposure of male rats. The
hematopoietic system also appeared to be a target of cyprodinil,
causing mild anemia in rats exposed subchronically. Chronic effects in
dogs were limited to decreased body-weight gain, decreased food
consumption and decreased food efficiency. There was no evidence of
increased susceptibility in the developmental rat or rabbit study
following in utero exposure or in the 2-generation reproduction study
following prenatal or postnatal exposure. There was no evidence of
neuropathological or other neurological effects in the available
subchronic neurotoxicity study. The results of a preliminary
immunotoxicity study provided no evidence for immunotoxicity. There was
no evidence of carcinogenic potential in either the rat chronic
toxicity/carcinogenicity or mouse carcinogenicity studies.
B. Toxicological Points of Departure/Levels of Concern
Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern (LOC) to use in evaluating the risk posed by human exposure to
the pesticide. For hazards that have a threshold below which there is
no appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are
[[Page 5693]]
observed (the NOAEL) and the lowest dose at which adverse effects of
concern are identified (the LOAEL). Uncertainty/safety factors are used
in conjunction with the POD to calculate a safe exposure level--
generally referred to as a population-adjusted dose (PAD) or a
reference dose (RfD)--and a safe margin of exposure (MOE). 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 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 cyprodinil used for
human risk assessment is discussed in Unit III.A of the final rule
published in the Federal Register of April 28, 2010 (75 FR 22242) (FRL-
8818-8).
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to cyprodinil, EPA considered exposure under the petitioned-
for tolerances as well as all existing cyprodinil tolerances in 40 CFR
180.532. EPA assessed dietary exposures from cyprodinil 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. Such effects were identified
for cyprodinil. In estimating acute dietary exposure, EPA used the
Dietary Exposure Evaluation Model-Food Consumption Intake Database
(DEEM-FCIDTM, Version 2.03), which uses food consumption
data from the U. S. Department of Agriculture (USDA) Continuing Surveys
of Food Intakes by Individuals (CSFII) from 1994-1996 and 1998. As to
residue levels in food, EPA performed a screening level acute dietary
exposure analysis for the population subgroup females 13 to 49 only. No
acute endpoint was identified for the remaining population subgroups.
Tolerance level residues and 100 percent crop treated (PCT) assumptions
were used. DEEM default and empirical processing factors were used to
modify the tolerance values.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment, EPA used the DEEM-FCIDTM, Version 2.03, which
uses food consumption data from the USDA 1994-1996 and 1998 CSFII. A
moderately refined chronic dietary exposure analysis was performed for
the general U.S. population and various population subgroups. Average
field trial residues for pome fruit, tolerance level residues for the
remaining commodities, and 100 PCT assumptions were used. DEEM default
and empirical processing factors were used.
iii. Cancer. EPA determines whether quantitative cancer exposure
and risk assessments are appropriate for a food-use pesticide based on
the weight of the evidence from cancer studies and other relevant data.
If quantitative cancer risk assessment is appropriate, cancer risk may
be quantified using a linear or non-linear approach. If sufficient
information on the carcinogenic mode of action is available, a
threshold or non-linear approach is used and a cancer RfD is calculated
based on an earlier non-cancer key event. If carcinogenic mode of
action data are not available, or if the mode of action data determine
a mutagenic mode of action, a default linear cancer slope factor
approach is utilized. Data summarized in Table 2 of the document
``Human Health Risk--Cyprodinil Increased Pome Fruit Tolerance'', pp.
24 through 29, in docket ID number EPA-HQ-OPP-2010-0385 at https://www.regulations.gov, showed no evidence of carcinogenic potential in
either the rat chronic toxicity/carcinogenicity or mouse
carcinogenicity studies. EPA therefore concluded that cyprodinil does
not pose a cancer risk to humans. Therefore a dietary exposure
assessment for the purpose of assessing cancer risk is unnecessary.
iv. Anticipated residue and percent crop treated (PCT) information.
Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and
information on the anticipated residue levels of pesticide residues in
food and the actual levels of pesticide residues that have been
measured in food. If EPA relies on such information, EPA must require
pursuant to FFDCA section 408(f)(1) that data be provided 5 years after
the tolerance is established, modified, or left in effect,
demonstrating that the levels in food are not above the levels
anticipated. For the present action, EPA will issue such data call-ins
as are required by FFDCA section 408(b)(2)(E) and authorized under
FFDCA section 408(f)(1). Data will be required to be submitted no later
than 5 years from the date of issuance of these tolerances.
2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for cyprodinil in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of cyprodinil. 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
cyprodinil for acute exposures are 34.79 parts per billion (ppb) for
surface water and 0.0861 ppb for ground water and for chronic exposures
for non-cancer assessments are estimated to be 24.65 ppb for surface
water and 0.0861 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 34.79 ppb was used to
assess the contribution to drinking water. For chronic dietary risk
assessment, the water concentration value of 24.65 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). Cyprodinil 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 cyprodinil to share a common mechanism of
toxicity with any other substances, and cyprodinil does not appear to
produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
cyprodinil 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
[[Page 5694]]
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 database is considered
adequate for selection of study endpoints and determination of a dose/
response to characterize the potential prenatal or postnatal toxicity
of cyprodinil to infants and children. No increase in susceptibility
was seen in developmental toxicity studies in rat and rabbit or
reproductive toxicity studies in the rat. Toxicity to offspring was
observed at dose levels the same or greater than those causing maternal
or parental toxicity. Based on the results of developmental and
reproductive toxicity studies, there is not a concern for increased
qualitative and/or quantitative susceptibility following in utero
exposure to cyprodinil.
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 toxicology database for cyprodinil is largely complete,
missing only the recently-required acute neurotoxicity study and the
functional immunotoxicity study. EPA has determined that an additional
uncertainty factor is not needed to account for the lack of these
studies for the following reasons:
The functional immunotoxicity study for cyprodinil is not expected
to alter the RfD. A preliminary immunotoxicity study was submitted. The
study did not meet all requirements, but is considered Upgradeable/
Guideline. The registrant must either submit a required Natural Killer
cell activity assay or provide justification that it is not needed.
Otherwise, the results of the preliminary study provided no evidence of
immunotoxicity. Specifically, there were no treatment-related effects
on absolute, adjusted, or relative spleen or thymus weights; no effects
on specific activity or total activity of splenic IgM antibody-forming
cells to the T cell-dependent antigen sRBC. There is no evidence in the
other existing studies that cyprodinil targets the immune system. No
other immunotoxicity studies have been submitted.
The acute neurotoxicity study is not expected to alter the RfD for
cyprodinil because the available data show no evidence of neurotoxic
potential for cyprodinil. The NOAEL from an acute study is unlikely to
be appreciably lower than the NOAEL of 600 mg/kg/day from the
subchronic neurotoxicity study. Neurotoxicity was not observed in
subchronic neurotoxicity study or the prenatal developmental toxicity
studies in rats and rabbits.
ii. A developmental neurotoxicity study is not required. As noted,
the available data show no evidence of neurotoxic potential for
cyprodinil.
iii. There is no evidence that cyprodinil results in increased
susceptibility in in utero rats or rabbits in the prenatal
developmental studies or in young rats in the 2-generation reproduction
study.
iv. There are no residual uncertainties identified in the exposure
databases. The acute dietary food exposure assessments were performed
based on 100 PCT and tolerance-level residues. The chronic dietary food
exposure assessments were performed based on average field trial
residues for pome fruit, tolerance level residues for the remaining
commodities, and 100 PCT assumptions. EPA made conservative
(protective) assumptions in the ground and surface water modeling used
to assess exposure to cyprodinil in drinking water. These assessments
will not underestimate the exposure and risks posed by cyprodinil.
E. Aggregate Risks and Determination of Safety
EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute population adjusted dose (aPAD) and chronic population adjusted
dose (cPAD). For linear cancer risks, EPA calculates the lifetime
probability of acquiring cancer 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 appropriate PODs to ensure that an adequate MOE exists.
1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to cyprodinil will occupy 4% of the aPAD for females 13 to 49 years
old, the population group receiving the greatest exposure.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
cyprodinil from food and water will utilize 86% of the cPAD for
children 1 to 2 years old the population group receiving the greatest
exposure.
3. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, cyprodinil is not expected to pose a cancer risk to humans.
4. 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 cyprodinil residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate High Performance Liquid Chromatography, using ultra-violet
detection (HPLC/UV) methods with column switching (Syngenta Methods AG-
631 and AG-631B) are available for enforcing tolerances of cyprodinil
on plant commodities. The level of quantitation (LOQs) for these
methods range from 0.01 to 0.05 ppm depending on the plant commodities.
Method AG-631B also contains procedures for confirmatory analysis by
gas chromatography with nitrogen phosphorus detection (GC/NPD).
An adequate HPLC/mass spectrometry method (GRM010.01A) is also
available for enforcing tolerances in livestock commodities. This
method determines residues of both parent and the metabolite CGA-304075
(free and conjugated), expressed as parent. The LOQ is 0.01 ppm for
each analyte for a combined LOQ of 0.02 ppm.
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
In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits
[[Page 5695]]
(MRLs) established by the Codex Alimentarius Commission (Codex), as
required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint
U.N. Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
The Codex has established MRLs for residues of cyprodinil in/on
apple (0.05 mg/kg, the LOQ) and pear (1 mg/kg). There is also a
currently established Canadian MRL for residues of cyprodinil in/on
pome fruit (0.1 ppm); but none is established in Mexico. It is not
possible to harmonize with Codex and Canadian MRLs for residues of
cyprodinil in/on pome fruit commodities because the proposed use in the
United States results in residue levels greater than the Codex and
Canadian MRLs due to the shorter preharvest interval in the United
States.
C. Revisions to Petitioned-For Tolerances
Based on the submitted apple field trial and available apple
processing data, the currently established tolerance for residues of
cyprodinil in apple wet pomace will need to be increased from 0.15 ppm
to 4.6 ppm to cover the proposed amended uses of cyprodinil on pome
fruit. Additionally, the Agency has determined the currently
established 0.02 ppm tolerance level for meat byproducts of cattle,
goats, horses, and sheep are adequate but the currently established
tolerance expression for livestock commodities should be changed to
reflect measurements of both parent and metabolite CGA-304075.
V. Conclusion
Therefore, tolerances are established for residues of cyprodinil,
in or on pome fruit at 1.7 ppm and in apple wet pomace at 4.6 ppm.
Tolerances are also established for cyprodinil and (free and
conjugated) CGA-304075, expressed in parent equivalents on meat
byproducts of cattle, goats, horses, and sheep at 0.02 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) (Pub. L. 104-4).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note).
VII. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and to
the Comptroller General of the United States. EPA will submit a report
containing this rule and other required information to the U.S. Senate,
the U.S. House of Representatives, and the Comptroller General of the
United States prior to publication of this final rule in the Federal
Register. This final rule is not a ``major rule'' as defined by 5
U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: January 24, 2011.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
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 180.532 is amended by revising paragraph (a) to read:
Sec. 180.532 Cyprodinil; tolerances for residues.
(a) General. (1) Tolerances are established for residues of the
fungicide cyprodinil, including its metabolites and degradates, in or
on the commodities in the table below. Compliance with the tolerance
levels specified below is to be determined by measuring only cyprodinil
4-cyclopropyl-6-methyl-N-phenyl-2-pyrimidinamine.
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Almond..................................................... 0.02
Almond, hulls.............................................. 8.0
Apple, wet pomace.......................................... 4.6
Avocado.................................................... 1.2
Bean, dry.................................................. 0.6
Bean, succulent............................................ 0.6
Brassica, head and stem, subgroup 5A....................... 1.0
Brassica, leafy greens, subgroup 5B........................ 10.0
[[Page 5696]]
Bushberry subgroup 13B..................................... 3.0
Caneberry subgroup 13A..................................... 10
Canistel................................................... 1.2
Canola, seed \1\........................................... 0.03
Citrus, dried pulp......................................... 8.0
Citrus, oil................................................ 340
Fruit, pome................................................ 1.7
Fruit, stone............................................... 2.0
Grape...................................................... 2.0
Grape, raisin.............................................. 3.0
Herb subgroup 19A, dried, except parsley................... 15.0
Herb subgroup 19A, fresh, except parsley................... 3.0
Juneberry.................................................. 3.0
Kiwifruit.................................................. 1.8
Leafy greens subgroup 4A, except spinach 35................ 30
Lemon...................................................... 0.60
Lime....................................................... 0.60
Lingonberry................................................ 3.0
Longan..................................................... 2.0
Lychee..................................................... 2.0
Mango...................................................... 1.2
Onion, bulb................................................ 0.60
Onion, green............................................... 4.0
Papaya..................................................... 1.2
Parsley, dried leaves...................................... 170
Parsley, leaves............................................ 35
Pistachio.................................................. 0.10
Pulasan.................................................... 2.0
Rambutan................................................... 2.0
Salal...................................................... 3.0
Sapodilla.................................................. 1.2
Sapote, black.............................................. 1.2
Sapote, mamey.............................................. 1.2
Spanish lime............................................... 2.0
Star apple................................................. 1.2
Strawberry................................................. 5.0
Tomatillo.................................................. 0.45
Tomato..................................................... 0.45
Tomato, paste.............................................. 1.0
Turnip, greens............................................. 10.0
Vegetable, cucurbit, group 9............................... 0.70
Vegetable, leaves of root and tuber, group 2............... 10
Vegetable, root, except sugarbeet, subgroup 1B 41.......... 0.75
Watercress................................................. 20
------------------------------------------------------------------------
\1\ Import only.
(2) Tolerances are established for residues of the fungicide
cyprodinil, including its metabolites and degradates, in the
commodities in the table below. Compliance with the tolerance levels
specified below is to be determined by measuring only the sum of
cyprodinil 4-cyclopropyl-6-methyl-N-phenyl-2-pyrimidinamine and free
and conjugated CGA-304075 4-(4-cyclopropyl-6-methyl-pyrimidin-2-
ylamino)-phenol, calculated as the stoichiometric equivalent of
cyprodinil.
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Cattle, meat byproducts..................................... 0.02
Goat, meat byproducts....................................... 0.02
Horse, meat byproducts...................................... 0.02
Sheep, meat byproducts...................................... 0.02
------------------------------------------------------------------------
* * * * *
[FR Doc. 2011-2157 Filed 2-1-11; 8:45 am]
BILLING CODE 6560-50-P