Cyprodinil; Pesticide Tolerances, 22240-22245 [2010-9835]
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nor have any CODEX Maximum Residue
Levels (MRLs) been established for any
food crops at this time.
VI. Conclusions
Therefore, an exemption from the
requirement of a tolerance is established
under 40 CFR 180.920 for PETAE (CAS
Reg. No. 68308–48–5) when used as an
inert ingredient (as surfactants, related
adjuvants of surfactants) in pesticide
formulations applied to growing crops
at a maximum of 20% by weight in
pesticide formulations.
VII. Statutory and Executive Order
Reviews
This final rule establishes a tolerance
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).
VIII. 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: April 15, 2010.
G. Jeffrey Herndon,
Acting 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. In §180.920, the table is amended
by adding alphabetically the following
inert ingredient to read as follows:
■
§ 180.920 Inert ingredients used preharvest; exemptions from the requirement
of a tolerance.
*
*
*
*
Inert ingredients
Limits
*
*
*
*
*
Tallowamine, ethoxylated, mixture of dihydrogen phosphate and monohydrogen phosphate
esters and the corresponding ammonium, calcium, potassium, and sodium salts of the phosphate esters, where the poly(oxyethylene) content averages 2–20 moles (CAS Reg. No.
68308–48–5)
*
*
*
*
*
Not to exceed 20% of
pesticide formulation
[FR Doc. 2010–9834 Filed 4–27–10; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
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40 CFR Part 180
[EPA–HQ–OPP–2009–0551; FRL–8818–8]
Cyprodinil; Pesticide Tolerances
AGENCY: Environmental Protection
Agency (EPA).
ACTION: Final rule.
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*
Uses
Surfactants, related
adjuvants of
surfactants
SUMMARY: This regulation establishes a
tolerance for residues of cyprodinil in or
on canola, seed. Syngenta Crop
Protection, Inc. requested these
tolerances under the Federal Food,
Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective April
28, 2010. Objections and requests for
hearings must be received on or before
June 28, 2010, and must be filed in
accordance with the instructions
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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–2009–0551. 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, 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.
ADDRESSES:
SUPPLEMENTARY INFORMATION:
I. General Information
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A. Does this Action Apply to Me?
You may be potentially affected by
this action if you are an agricultural
producer, food manufacturer, or
pesticide manufacturer. Potentially
affected entities may include, but are
not limited to those engaged in the
following activities:
• Crop production (NAICS code 111).
• Animal production (NAICS code
112).
• Food manufacturing (NAICS code
311).
• Pesticide manufacturing (NAICS
code 32532).
This listing is not intended to be
exhaustive, but rather to provide a guide
for readers regarding entities likely to be
affected by this action. Other types of
entities not listed in this unit could also
be affected. The North American
Industrial Classification System
(NAICS) codes have been provided to
assist you and others in determining
whether this action might apply to
certain entities. If you have any
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questions regarding the applicability of
this action to a particular entity, consult
the person listed under FOR FURTHER
INFORMATION CONTACT.
Special arrangements should be made
for deliveries of boxed information. The
Docket Facility telephone number is
(703) 305–5805.
B. How Can I Get Electronic Access to
Other Related Information?
You may access a frequently updated
electronic version of 40 CFR part 180
through the Government Printing
Office’s e-CFR cite at https://
www.gpoaccess.gov/ecfr. To access the
OPPTS harmonized test guidelines
referenced in this document
electronically, please go to https://
www.epa.gov/oppts and select ‘‘Test
Methods and Guidelines.’’
II. Petition for Tolerance
C. Can I File an Objection or Hearing
Request?
Under section 408(g) of FFDCA, 21
U.S.C. 346a, any person may file an
objection to any aspect of this regulation
and may also request a hearing on those
objections. You must file your objection
or request a hearing on this regulation
in accordance with the instructions
provided in 40 CFR part 178. To ensure
proper receipt by EPA, you must
identify docket ID number EPA–HQ–
OPP–2009–0551 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 June 28, 2010. 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 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–2009–0551, 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).
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In the Federal Register of September
4, 2009 (74 FR 45848) (FRL–8434–4),
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 8E7502) by
Syngenta Crop Protection, Inc., P.O. Box
18300, Greensboro, NC, 27409. The
petition requested that 40 CFR 180.532
be amended by establishing tolerances
for residues of the fungicide cyprodinil,
in or on canola, seed, imported at 0.03
parts per million (ppm). That notice
referenced a summary of the petition
prepared by Syngenta Crop Protection,
Inc., the registrant, 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.
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 2–
generation reproduction study following
prenatal or postnatal exposure. No
neurotoxicity studies with cyprodinil
are available. However, there was no
evidence of neuropathological effects in
the available oral-toxicity studies.
There was no evidence of
carcinogenic potential in either the rat
chronic toxicity/carcinogenicity or
mouse carcinogenicity studies and no
concern for mutagenicity.
Toxicological points of departure
(PODs) were selected for dietary and
drinking water exposure scenarios. A
POD for acute dietary exposure was
selected for the population subgroup
females 13 to 49 years old based on a
developmental toxicity study in rabbits.
No acute endpoint was identified for the
remaining population subgroups. The
POD for chronic dietary exposure was
selected from a chronic/carcinogenicity
feeding study in rats.
Specific information on the studies
received and the nature of the adverse
effects caused by cyprodinil 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 document
‘‘Cyprodinil Human Health Risk
Assessment for Proposed New Use of
Cyprodinil on Imported Canola Seed’’,
pp. 24 through 27, in docket ID number
EPA–HQ–OPP–2009–0551.
B. Toxicological Points of Departure/
Levels of Concern
Once a pesticide’s toxicological
profile is determined, EPA identifies the
toxicological 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
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 shown in the
Table of this unit.
TABLE — SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR CYPRODINIL FOR USE IN HUMAN RISK ASSESSMENT
Point of Departure and Uncertainty/
Safety Factors
Exposure/Scenario
RfD, PAD, LOC for Risk
Assessment
Study and Toxicological
Effects
Acute dietary
(Females 13–50 years of age)
NOAEL = 150 milligrams/kilograms/
day (mg/kg/day) UFA = 10x
UFH = 10x
FQPA SF = 1x
Acute RfD = 1.5 mg/kg/day
aPAD = 1.5 mg/kg/day
Developmental Toxicity - rabbit
LOAEL = 400 mg/kg/day
based on slight increase of
litters showing extra ribs
Chronic dietary
All populations
NOAEL= 2.7 mg/kg/day UFA = 10x
UFH = 10x
FQPA SF = 1x
Chronic RfD = 0.027 mg/kg/
day
cPAD = 0.027 mg/kg/day
2–Year Chronic Toxicity/Carcinogenicity - rat
LOAEL = 35.6 mg/kg/day
based on degenerative liver
lesions (spongiosis hepatic)
in males
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Cancer
all routes
Not likely to be carcinogenic in humans.
UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members of the human population
(intraspecies). UFL = use of a LOAEL to extrapolate a NOAEL. UFS = use of a short-term study for long-term risk assessment. UFDB = to account for the absence of data or other data deficiency. FQPA SF = Food Quality Protection Act Safety Factor. PAD = population adjusted dose
(a = acute, c = chronic). RfD = reference dose. MOE = margin of exposure. LOC = level of concern.
C. Exposure Assessment
1. Dietary exposure from food and
feed uses. In evaluating dietary
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exposure to cyprodinil, EPA considered
exposure under the petitioned-for
tolerances as well as all existing
cyprodinil tolerances in 40 CFR
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180.532. EPA assessed dietary
exposures from cyprodinil in food as
follows:
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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 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 did not use anticipated
residue and/or percent crop treated
(PCT) information in the acute dietary
assessment for cyprodinil. Tolerance
level residues and 100 PCT were
assumed for all existing and proposed
food commodities.
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
did not use anticipated residue and/or
PCT information in the chronic dietary
assessment for cyprodinil. Tolerance
level residues and 100 PCT were
assumed for all existing and proposed
food commodities.
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. Cancer risk is 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 noncancer key event.
If carcinogenic mode of action data are
not available, or if the mode of action
data determines a mutagenic mode of
action, a default linear cancer slope
factor approach is utilized.
Based on the data summarized in Unit
III.A., EPA has concluded that
cyprodinil is not likely to be
carcinogenic to humans. Therefore, a
dietary exposure assessment for the
purpose of assessing cancer risk is
unnecessary.
iv. Anticipated residue and PCT
information. EPA did not use
anticipated residue and/or PCT
information in the dietary assessment
for cyprodinil. Tolerance level residues
and/or 100 PCT were assumed for all
food commodities.
2. Dietary exposure from drinking
water. The Agency used screening level
water exposure models in the dietary
exposure analysis and risk assessment
for cyprodinil in drinking water. These
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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.
EPA estimated the surface water
exposure levels using the the Pesticide
Root Zone Model/Exposure Analysis
Modeling System Ground water
estimates were calculated using the Tier
1 Screening Concentration in Ground
Water model. Estimated Drinking Water
Concentrations for cyprodinil and its
metabolite CGA–249287 were derived
based on a maximum application rate of
0.469 pound active ingredient / per acre
(lb a.i./A (applied 3 times/season)) on
grapes assuming minimum intervals
between application. The
concentrations have been adjusted with
the Percent Crop Area (PCA) of 0.87 for
a national assessment.
Estimated drinking water
concentrations of cyprodinil are:
i. 35 parts per billion (ppb) for surface
water and 0.11 ppb for ground water for
acute exposures; and
ii. 20 ppb for surface water and 0.11
ppb for ground water for chronic noncancer exposures.
Modeled estimates of drinking water
concentrations were directly entered
into the dietary exposure model. For
acute dietary risk assessment, the water
concentration value of 35 ppb was used
to assess the contribution to drinking
water. For chronic dietary risk
assessment, the water concentration of
value 20 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 does not have, at this time,
available data to determine whether
cyprodinil has a common mechanism of
toxicity with other substances. Unlike
other pesticides for which EPA has
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followed a cumulative risk approach
based on a common mechanism of
toxicity, EPA has not made a common
mechanism of toxicity finding as to
cyprodinil and any other substances
and, cyprodinil does not appear to
produce a toxic metabolite produced by
other substances which have tolerances
in the U. S. For the purposes of this
tolerance reassessment action, therefore,
EPA has not assumed that cyprodinil
has 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 the policy statements
released by EPA’s OPP concerning
common mechanism determinations
and procedures for cumulating effects
from substances found to have a
common mechanism on EPA’s website
at https://www.epa.gov/fedrgstr/
EPA_PEST/2002/January/Day_16/.
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.
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 toxicity database for cyprodinil
is complete except for a Neurotoxicity
Battery (870.6200 a and b) and an
Immunotoxicity Study (870.7800) which
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are required under the revised 40 CFR
part 158 Toxicology Data Requirements.
Based on the results of the available
toxicity studies for cyprodinil, however,
there is no evidence of neurotoxicity or
immunotoxicity, and EPA does not
believe that these required studies will
demonstrate that the PADs need to be
lowered.
ii. There is no indication that
cyprodinil is a neurotoxic chemical and
there is no need for a developmental
neurotoxicity study or additional UFs to
account for neurotoxicity.
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.
EPA made conservative (protective)
assumptions in estimating dietary
exposure and in the and drinking water
modeling used to assess exposure to
cyprodinil in drinking water. These
assessments will not underestimate the
exposure and risks posed by cyprodinil.
sroberts on DSKD5P82C1PROD with RULES
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 PAD (aPAD) and
chronic PAD (cPAD). For linear cancer
risks, EPA calculates the lifetime
probability of acquiring cancer given the
estimated aggregate exposure. Shortterm, intermediate-term, and chronicterm 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 70% of
the cPAD for children 1 to 2 years old,
the population group receiving the
greatest exposure. There are no
residential uses for cyprodinil.
3. Aggregate cancer risk for U.S.
population. Based on the lack of
evidence of carcinogenicity in mice and
rats at doses that were judged to be
adequate to assess the carcinogenic
VerDate Mar<15>2010
16:00 Apr 27, 2010
Jkt 220001
potential, 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 enforcement methodology
(namely, high performance liquid
chromatography with ultraviolet
detector (HPLC/UV)) is available to
enforce the tolerance expression on
plant commodities. In addition, a high
performance liquid chromatography
with mass spectrometry (HPLC/MS)
method (Method No. GRM010.01A) is
available for determining residues of
cyprodinil and its metabolite CGA–
304075 (free+conjugated) in livestock
commodities.
These methods may be requested
from: Chief, Analytical Chemistry
Branch, Environmental Science Center,
701 Mapes Rd., Ft. Meade, MD 20755–
5350; telephone number: (410) 305–
2905; e-mail address:
residuemethods@epa.gov.
B. International Residue Limits
There are no established or proposed
Codex, Canadian or Mexican MRLs for
cyprodinil on canola.
V. Conclusion
Therefore, a tolerance is established
for residues of cyprodinil, in or on
canola, seed, at 0.03 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
PO 00000
Frm 00040
Fmt 4700
Sfmt 4700
considerations under Executive Order
12898, entitled Federal Actions to
Address Environmental Justice in
Minority Populations and Low-Income
Populations (59 FR 7629, February 16,
1994).
Since tolerances and exemptions that
are established on the basis of a petition
under section 408(d) of FFDCA, such as
the tolerance in this final rule, do not
require the issuance of a proposed rule,
the requirements of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
This final rule directly regulates
growers, food processors, food handlers,
and food retailers, not States or tribes,
nor does this action alter the
relationships or distribution of power
and responsibilities established by
Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such,
the Agency has determined that this
action will not have a substantial direct
effect on States or tribal governments,
on the relationship between the national
government and the States or tribal
governments, or on the distribution of
power and responsibilities among the
various levels of government or between
the Federal Government and Indian
tribes. Thus, the Agency has determined
that Executive Order 13132, entitled
Federalism (64 FR 43255, August 10,
1999) and Executive Order 13175,
entitled Consultation and Coordination
with Indian Tribal Governments (65 FR
67249, November 9, 2000) do not apply
to this final rule. In addition, this final
rule does not impose any enforceable
duty or contain any unfunded mandate
as described under Title II of the
Unfunded Mandates Reform Act of 1995
(UMRA) (Public Law 104–4).
This action does not involve any
technical standards that would require
Agency consideration of voluntary
consensus standards pursuant to section
12(d) of the National Technology
Transfer and Advancement Act of 1995
(NTTAA), Public Law 104–113, section
12(d) (15 U.S.C. 272 note).
VII. Congressional Review Act
The Congressional Review Act, 5
U.S.C. 801 et seq., generally provides
that before a rule may take effect, the
agency promulgating the rule must
submit a rule report to each House of
the Congress and to the Comptroller
General of the United States. EPA will
submit a report containing this rule and
other required information to the U.S.
Senate, the U.S. House of
Representatives, and the Comptroller
General of the United States prior to
publication of this final rule in the
Federal Register. This final rule is not
E:\FR\FM\28APR1.SGM
28APR1
Federal Register / Vol. 75, No. 81 / Wednesday, April 28, 2010 / Rules and Regulations
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: April 15, 2010.
G. Jeffery Herndon,
Acting 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, in paragraph (a),
alphabetically add the following
commoditiy to the table to read as
follows:
■
§ 180.532 Cyprodinil; tolerances for
residues.
(a) * * *
Commodity
Parts per million
*
*
*
Canola, seed1 .................
*
*
*
1
*
*
*
*
0.03
*
Import only
*
*
*
*
[FR Doc. 2010–9835 Filed 4–27–10; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
I. General Information
[EPA–HQ–OPP–2008–0772; FRL–8818–5]
A. Does this Action Apply to Me?
Imidacloprid; Pesticide Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
sroberts on DSKD5P82C1PROD with RULES
AGENCY:
SUMMARY: This regulation establishes
tolerances for combined residues of
imidacloprid in or on vegetables, bulb,
group 3; cereal grains, group 15 and
cereal grains, forage, fodder and straw,
group 16. This regulation also deletes
tolerances for various commodities and
tolerances from direct/inadvertent
residues on cereal grains, group 15 and
cereal grains, forage, fodder and straw,
group 16, as they will be superseded by
group tolerances. Bayer CropScience
requested these tolerances under the
Federal Food, Drug, and Cosmetic Act
(FFDCA).
16:00 Apr 27, 2010
EPA has established a
docket for this action under docket
identification (ID) number EPA–HQ–
OPP–2008–0772. 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:
Kable Bo Davis, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
(703) 306–0415; e-mail address:
davis.kable@epa.gov.
ADDRESSES:
SUPPLEMENTARY INFORMATION:
40 CFR Part 180
VerDate Mar<15>2010
DATES: This regulation is effective April
28, 2010. Objections and requests for
hearings must be received on or before
June 28, 2010, and must be filed in
accordance with the instructions
provided in 40 CFR part 178 (see also
Unit I.C. of the SUPPLEMENTARY
INFORMATION).
Jkt 220001
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
PO 00000
Frm 00041
Fmt 4700
Sfmt 4700
22245
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?
You may access a frequently updated
electronic version of EPA’s tolerance
regulations at 40 CFR part 180 through
the Government Printing Office’s e-CFR
cite at https://www.gpoaccess.gov/ecfr.
C. Can I File an Objection or Hearing
Request?
Under section 408(g) of FFDCA, 21
U.S.C. 346a, any person may file an
objection to any aspect of this regulation
and may also request a hearing on those
objections. You must file your objection
or request a hearing on this regulation
in accordance with the instructions
provided in 40 CFR part 178. To ensure
proper receipt by EPA, you must
identify docket ID number EPA–HQ–
OPP–2008–0772 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 June 28, 2010.
In addition to filing an objection or
hearing request with the Hearing Clerk
as described in 40 CFR part 178, please
submit a copy of the filing that does not
contain any CBI for inclusion in the
public docket that is described in
ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2
may be disclosed publicly by EPA
without prior notice. Submit this copy,
identified by docket ID number EPA–
HQ–OPP–2008–0772, 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
E:\FR\FM\28APR1.SGM
28APR1
]]>Agencies
[Federal Register Volume 75, Number 81 (Wednesday, April 28, 2010)]
[Rules and Regulations]
[Pages 22240-22245]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-9835]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2009-0551; FRL-8818-8]
Cyprodinil; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes a tolerance for residues of
cyprodinil in or on canola, seed. Syngenta Crop Protection, Inc.
requested these tolerances under the Federal Food, Drug, and Cosmetic
Act (FFDCA).
DATES: This regulation is effective April 28, 2010. Objections and
requests for hearings must be received on or before June 28, 2010, and
must be filed in accordance with the instructions
[[Page 22241]]
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-2009-0551. 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,
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.
B. How Can I Get Electronic Access to Other Related Information?
You may access a frequently updated electronic version of 40 CFR
part 180 through the Government Printing Office's e-CFR cite at https://www.gpoaccess.gov/ecfr. To access the OPPTS harmonized test guidelines
referenced in this document electronically, please go to https://www.epa.gov/oppts and select ``Test Methods and Guidelines.''
C. Can I File an Objection or Hearing Request?
Under section 408(g) of FFDCA, 21 U.S.C. 346a, any person may file
an objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2009-0551 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
June 28, 2010. 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 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-2009-0551, 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 September 4, 2009 (74 FR 45848) (FRL-
8434-4), 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
8E7502) by Syngenta Crop Protection, Inc., P.O. Box 18300, Greensboro,
NC, 27409. The petition requested that 40 CFR 180.532 be amended by
establishing tolerances for residues of the fungicide cyprodinil, in or
on canola, seed, imported at 0.03 parts per million (ppm). That notice
referenced a summary of the petition prepared by Syngenta Crop
Protection, Inc., the registrant, 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.
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.
[[Page 22242]]
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. No neurotoxicity studies with
cyprodinil are available. However, there was no evidence of
neuropathological effects in the available oral-toxicity studies.
There was no evidence of carcinogenic potential in either the rat
chronic toxicity/carcinogenicity or mouse carcinogenicity studies and
no concern for mutagenicity.
Toxicological points of departure (PODs) were selected for dietary
and drinking water exposure scenarios. A POD for acute dietary exposure
was selected for the population subgroup females 13 to 49 years old
based on a developmental toxicity study in rabbits. No acute endpoint
was identified for the remaining population subgroups. The POD for
chronic dietary exposure was selected from a chronic/carcinogenicity
feeding study in rats.
Specific information on the studies received and the nature of the
adverse effects caused by cyprodinil 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 document ``Cyprodinil Human Health Risk
Assessment for Proposed New Use of Cyprodinil on Imported Canola
Seed'', pp. 24 through 27, in docket ID number EPA-HQ-OPP-2009-0551.
B. Toxicological Points of Departure/Levels of Concern
Once a pesticide's toxicological profile is determined, EPA
identifies the toxicological 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 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 shown in the Table of this unit.
Table -- Summary of Toxicological Doses and Endpoints for cyprodinil for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
Point of Departure and
Exposure/Scenario Uncertainty/Safety RfD, PAD, LOC for Risk Study and Toxicological
Factors Assessment Effects
----------------------------------------------------------------------------------------------------------------
Acute dietary NOAEL = 150 milligrams/ Acute RfD = 1.5 mg/kg/ Developmental Toxicity
(Females 13-50 years of age)........ kilograms/day (mg/kg/ day rabbit
day) UFA = 10x aPAD = 1.5 mg/kg/day... LOAEL = 400 mg/kg/day
UFH = 10x.............. based on slight
FQPA SF = 1x........... increase of litters
showing extra ribs
----------------------------------------------------------------------------------------------------------------
Chronic dietary NOAEL= 2.7 mg/kg/day Chronic RfD = 0.027 mg/ 2-Year Chronic Toxicity/
All populations...................... UFA = 10x kg/day Carcinogenicity - rat
UFH = 10x.............. cPAD = 0.027 mg/kg/day. LOAEL = 35.6 mg/kg/day
FQPA SF = 1x........... based on degenerative
liver lesions
(spongiosis hepatic)
in males
----------------------------------------------------------------------------------------------------------------
Cancer Not likely to be carcinogenic in humans.
all routes...........................
----------------------------------------------------------------------------------------------------------------
UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members
of the human population (intraspecies). UFL = use of a LOAEL to extrapolate a NOAEL. UFS = use of a short-term
study for long-term risk assessment. UFDB = to account for the absence of data or other data deficiency. FQPA
SF = Food Quality Protection Act Safety Factor. PAD = population adjusted dose (a = acute, c = chronic). RfD =
reference dose. MOE = margin of exposure. LOC = level of concern.
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:
[[Page 22243]]
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 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 did not use anticipated residue and/or percent crop
treated (PCT) information in the acute dietary assessment for
cyprodinil. Tolerance level residues and 100 PCT were assumed for all
existing and proposed food commodities.
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 did not use
anticipated residue and/or PCT information in the chronic dietary
assessment for cyprodinil. Tolerance level residues and 100 PCT were
assumed for all existing and proposed food commodities.
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.
Cancer risk is 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 noncancer key event. If carcinogenic
mode of action data are not available, or if the mode of action data
determines a mutagenic mode of action, a default linear cancer slope
factor approach is utilized.
Based on the data summarized in Unit III.A., EPA has concluded
that cyprodinil is not likely to be carcinogenic to humans. Therefore,
a dietary exposure assessment for the purpose of assessing cancer risk
is unnecessary.
iv. Anticipated residue and PCT information. EPA did not use
anticipated residue and/or PCT information in the dietary assessment
for cyprodinil. Tolerance level residues and/or 100 PCT were assumed
for all food commodities.
2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for 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.
EPA estimated the surface water exposure levels using the the
Pesticide Root Zone Model/Exposure Analysis Modeling System Ground
water estimates were calculated using the Tier 1 Screening
Concentration in Ground Water model. Estimated Drinking Water
Concentrations for cyprodinil and its metabolite CGA-249287 were
derived based on a maximum application rate of 0.469 pound active
ingredient / per acre (lb a.i./A (applied 3 times/season)) on grapes
assuming minimum intervals between application. The concentrations have
been adjusted with the Percent Crop Area (PCA) of 0.87 for a national
assessment.
Estimated drinking water concentrations of cyprodinil are:
i. 35 parts per billion (ppb) for surface water and 0.11 ppb for
ground water for acute exposures; and
ii. 20 ppb for surface water and 0.11 ppb for ground water for
chronic non-cancer exposures.
Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For acute dietary risk
assessment, the water concentration value of 35 ppb was used to assess
the contribution to drinking water. For chronic dietary risk
assessment, the water concentration of value 20 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 does not have, at this time, available data to determine
whether cyprodinil has a common mechanism of toxicity with other
substances. Unlike other pesticides for which EPA has followed a
cumulative risk approach based on a common mechanism of toxicity, EPA
has not made a common mechanism of toxicity finding as to cyprodinil
and any other substances and, cyprodinil does not appear to produce a
toxic metabolite produced by other substances which have tolerances in
the U. S. For the purposes of this tolerance reassessment action,
therefore, EPA has not assumed that cyprodinil has 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
the policy statements released by EPA's OPP concerning common mechanism
determinations and procedures for cumulating effects from substances
found to have a common mechanism on EPA's website at https://www.epa.gov/fedrgstr/EPA_PEST/2002/January/Day_16/.
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. 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 toxicity database for cyprodinil is complete except for a
Neurotoxicity Battery (870.6200 a and b) and an Immunotoxicity Study
(870.7800) which
[[Page 22244]]
are required under the revised 40 CFR part 158 Toxicology Data
Requirements. Based on the results of the available toxicity studies
for cyprodinil, however, there is no evidence of neurotoxicity or
immunotoxicity, and EPA does not believe that these required studies
will demonstrate that the PADs need to be lowered.
ii. There is no indication that cyprodinil is a neurotoxic chemical
and there is no need for a developmental neurotoxicity study or
additional UFs to account for neurotoxicity.
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. EPA made conservative (protective) assumptions in estimating
dietary exposure and in the and drinking 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 PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-term, intermediate-term, 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 70% of the cPAD for
children 1 to 2 years old, the population group receiving the greatest
exposure. There are no residential uses for cyprodinil.
3. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in mice and rats at doses that were judged
to be adequate to assess the carcinogenic potential, 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 enforcement methodology (namely, high performance liquid
chromatography with ultraviolet detector (HPLC/UV)) is available to
enforce the tolerance expression on plant commodities. In addition, a
high performance liquid chromatography with mass spectrometry (HPLC/MS)
method (Method No. GRM010.01A) is available for determining residues of
cyprodinil and its metabolite CGA- 304075 (free+conjugated) in
livestock commodities.
These methods may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD
20755-5350; telephone number: (410) 305-2905; e-mail address:
residuemethods@epa.gov.
B. International Residue Limits
There are no established or proposed Codex, Canadian or Mexican
MRLs for cyprodinil on canola.
V. Conclusion
Therefore, a tolerance is established for residues of cyprodinil,
in or on canola, seed, at 0.03 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 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
[[Page 22245]]
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: April 15, 2010.
G. Jeffery Herndon,
Acting Director, Registration Division, Office of Pesticide Programs.
0
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. Section 180.532, in paragraph (a), alphabetically add the following
commoditiy to the table to read as follows:
Sec. 180.532 Cyprodinil; tolerances for residues.
(a) * * *
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
* * * * *
Canola, seed\1\...................................... 0.03
* * * * *
------------------------------------------------------------------------
\1\ Import only
* * * * *
[FR Doc. 2010-9835 Filed 4-27-10; 8:45 am]
BILLING CODE 6560-50-S
