Cyprodinil; Pesticide Tolerances, 22914-22919 [2016-09028]
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Federal Register / Vol. 81, No. 75 / Tuesday, April 19, 2016 / Rules and Regulations
Sector Columbia River at 503–861–6211
or via VHF-Channel 16.
Dated: April 6, 2016.
D.L. Cottrell,
Captain, U.S. Coast Guard, Acting
Commander, Thirteenth Coast Guard District.
[FR Doc. 2016–09027 Filed 4–18–16; 8:45 am]
BILLING CODE 9110–04–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2015–0180; FRL–9943–85]
Cyprodinil; Pesticide Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes
tolerances for residues of cyprodinil in
or on Nut, Tree, Crop Group 14–12;
except almond and pistachio. Syngenta
Crop Protection, LLC requested these
tolerances under the Federal Food,
Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective April
19, 2016. Objections and requests for
hearings must be received on or before
June 20, 2016, 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:
The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2015–0180, is
available at https://www.regulations.gov
or at the Office of Pesticide Programs
Regulatory Public Docket (OPP Docket)
in the Environmental Protection Agency
Docket Center (EPA/DC), West William
Jefferson Clinton Bldg., Rm. 3334, 1301
Constitution Ave. NW., Washington, DC
20460–0001. The Public Reading Room
is open from 8:30 a.m. to 4:30 p.m.,
Monday through Friday, excluding legal
holidays. The telephone number for the
Public Reading Room is (202) 566–1744,
and the telephone number for the OPP
Docket is (703) 305–5805. Please review
the visitor instructions and additional
information about the docket available
at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
Susan Lewis, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington,
DC 20460–0001; main telephone
number: (703) 305–7090; email address:
RDFRNotices@epa.gov.
SUPPLEMENTARY INFORMATION:
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ADDRESSES:
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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. The following
list of North American Industrial
Classification System (NAICS) codes is
not intended to be exhaustive, but rather
provides a guide to help readers
determine whether this document
applies to them. Potentially affected
entities may include:
• Crop production (NAICS code 111).
• Animal production (NAICS code
112).
• Food manufacturing (NAICS code
311).
• Pesticide manufacturing (NAICS
code 32532).
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.ecfr.gov/cgi-bin/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/
40tab_02.tpl.
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–2015–0180 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 20, 2016. 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 (excluding
any Confidential Business Information
(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 the non-CBI copy of your
objection or hearing request, identified
by docket ID number EPA–HQ–OPP–
2015–0180, by one of the following
methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the online
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instructions for submitting comments.
Do not submit electronically any
information you consider to be CBI or
other information whose disclosure is
restricted by statute.
• Mail: OPP Docket, Environmental
Protection Agency Docket Center (EPA/
DC), (28221T), 1200 Pennsylvania Ave.
NW., Washington, DC 20460–0001.
• Hand Delivery: To make special
arrangements for hand delivery or
delivery of boxed information, please
follow the instructions at https://
www.epa.gov/dockets/contacts.html.
Additional instructions on
commenting or visiting the docket,
along with more information about
dockets generally, is available at https://
www.epa.gov/dockets.
II. Summary of Petitioned-for Tolerance
In the Federal Register of April 22,
2015 (80 FR 22466) (FRL–9925–79),
EPA issued a document pursuant to
FFDCA section 408(d)(3), 21 U.S.C.
346a(d)(3), announcing the filing of a
pesticide petition (PP 4F8333) by
Syngenta Crop Protection, LLC, P.O.
Box 18300, Greensboro, NC 27419–
8300. The petition requested that 40
CFR 180.532 be amended by
establishing tolerances for residues of
the fungicide cyprodinil, 4-cyclopropyl6-methyl-N-phenyl-2-pyrimidinamine,
in or on Nut, Tree, Crop Group 14–12;
except almond and pistachio at 0.04
parts per million (ppm). That document
referenced a summary of the petition
prepared by Syngenta Crop Group, LLC,
the registrant, which is available in the
docket, https://www.regulations.gov.
Comments were received on the notice
of filing. EPA’s response to these
comments is discussed 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
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result to infants and children from
aggregate exposure to the pesticide
chemical residue. . . .’’
Consistent with FFDCA section
408(b)(2)(D), and the factors specified in
FFDCA section 408(b)(2)(D), 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.
The major target organs of cyprodinil
are the liver and the kidney. Liver
effects were consistent among male and
female rats and mice in both subchronic and chronic studies and
typically included increased liver
weights along with increases in serum
clinical chemistry parameters associated
with adverse effects on liver function
(i.e., increased cholesterol and
phospholipid levels). Microscopic
lesions in rats and mice included
hepatocyte hypertrophy and
hepatocellular necrosis. In the kidneys,
adverse effects were seen as chronic
tubular lesions and chronic kidney
inflammation following sub-chronic
exposure of male rats. Chronically,
cyprodinil caused increased kidney
weights and progressive nephropathy in
male rats. Chronic effects in dogs were
limited to decreased body-weight gain,
decreased food consumption and
decreased food efficiency; liver toxicity
was not seen in the dog. The
hematopoietic system also appeared to
be a target of cyprodinil as mild anemia
was seen in rats exposed subchronically (reductions in hematocrit
and hemoglobin and microcytosis).
Although increases in thyroid weight
and/or hypertrophy of thyroid follicular
cells were observed at higher doses in
the rat 28-day oral-toxicity studies and
in the 90-day oral-toxicity study in rats,
treatment related changes in thyroid
weights or gross/microscopic
observations were not observed in the
chronic rat study or in other studies.
A 28-day dietary immunotoxicity
study in mice resulted in no apparent
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suppression of the humoral component
of the immune system. The only effect
attributed to cyprodinil treatment was
higher mean absolute, relative (to body
weight), and adjusted liver weights for
the 5000 ppm group. 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
Immunoglobulin M antibody-forming
cells to the T cell-dependent red blood
cell antigens. No dermal or systemic
toxicity was seen following repeated
dermal application at the highest dose
in a 21-day dermal toxicity study in
rabbits.
An acute neurotoxicity study
indicated systemic toxicity with signs of
induced hunched posture, piloerection,
and reduced responsiveness to sensory
stimuli and reduced motor activity.
Females were slightly more affected
than males per daily clinical
observations, which disappeared by day
3 to 4. A dose-related reduction in body
temperature was seen in all treated
animals, thus hypothermia is
considered a compound-related effect in
the highest dose tested and was found
to be statistically significant, whereas
the lower dosed animals was not or only
marginally significant and was fully
reversible in all groups. Clinical signs,
hypothermia, and changes in motor
activity were found to all be reversible
by day 8 and 15 investigations. There
were no histopathological findings to
support evidence of damage to the
central nervous system, eyes, optic
nerves, or skeletal muscles. A subchronic neurotoxicity study showed no
treatment related effects on mortality,
clinical signs, or gross or histological
neuropathology. Functional
observational battery and motor activity
testing revealed no treatment related
effects up to the highest dose tested.
There was no evidence of increased
susceptibility in the developmental rat
or rabbit study following in utero
exposure or in the two-generation
reproduction study following pre- and
post-natal exposure. Fetal toxicity,
manifested as significantly lower fetal
weights and an increased incidence of
delayed ossification in the rat and a
slight increase in litters showing extra
ribs (13th) in the rabbit, was reported in
developmental toxicity studies. In a rat
two-generation reproduction study,
significantly lower pup weights for F1
and F2 offspring were observed.
However, each of these fetal/neonatal
effects occurred at the same dose levels
at which maternal toxicity (decreased
body weight gain) was observed and
were considered to be secondary to
maternal toxicity.
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Based on the lack of evidence of
carcinogenicity in mice and rats at doses
that were judged to be adequate to the
carcinogenic potential, cyprodinil was
classified as ‘‘not likely to be
carcinogenic to humans.’’
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 the document,
‘‘Human Health Risk Assessment for the
Petition Proposing a New Tolerance for
the Use of cyprodinil in/on Nut, Tree,
Crop Group 14–12; except almond and
pistachio’’ in docket ID number EPA–
HQ–OPP–2015–0180.
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 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 the NOAEL and the
LOAEL are identified. 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://
www2.epa.gov/pesticide-science-andassessing-pesticide-risks/assessinghuman-health-risk-pesticides.
A summary of the toxicological
endpoints for cyprodinil used for
human risk assessment is discussed in
Unit III.B. of the final rule published in
the Federal Register of October 16, 2012
(77 FR 49732) (FRL–9359–7).
C. Exposure Assessment
1. Dietary exposure from food and
feed uses. In evaluating dietary
exposure to cyprodinil, EPA considered
exposure under the petitioned-for
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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. EPA used food
consumption information from the
United States Department of Agriculture
(USDA) National Health and Nutrition
Examination Survey, What We Eat in
America, (NHANES/WWEIA). This
dietary survey was conducted from 2003
to 2008. As to residue levels in food,
EPA utilized the Dietary Exposure
Evaluation Model software with the
Food Commodity Intake Database
DEEM–FCID, Version 3.16 default
processing factors and tolerance-level
residues and 100 percent crop treated
(PCT) for all commodities.
ii. Chronic exposure. In conducting
the chronic dietary exposure assessment
EPA used food consumption
information from the USDA NHANES/
WWEIA dietary survey conducted from
2003 to 2008. As to residue levels in
food, EPA utilized residue data from
field trials to obtain average residues
and assumed 100 PCT. Empirically
derived processing factors were used in
these assessments when available; all
other processing factors used the
DEEM–FCID Version 7.81 default
processing factors.
iii. Cancer. Based on the data
summarized in Unit III.A., EPA has
concluded that cyprodinil does not pose
a cancer risk to humans. Therefore, a
dietary exposure assessment for the
purpose of assessing cancer risk was not
conducted.
iv. Anticipated residue 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.
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2. Dietary exposure from drinking
water. The Agency used screening level
water exposure models in the dietary
exposure analysis and risk assessment
for cyprodinil and CGA 249287 in
drinking water. These simulation
models take into account data on the
physical, chemical, and fate/transport
characteristics of cyprodinil and CGA
249287. Further information regarding
EPA drinking water models used in
pesticide exposure assessment can be
found at https://www2.epa.gov/pesticidescience-and-assessing-pesticide-risks/
about-water-exposure-models-usedpesticide.
Based on the Pesticide Root Zone
Model/Exposure Analysis Modeling
System (PRZM/EXAMS), Screening
Concentration in Ground Water (SCI–
GROW) models and Pesticide Root Zone
Model Ground Water (PRZM GW), the
estimated drinking water concentrations
(EDWCs) of cyprodinil and CGA 249287
for acute exposures are estimated to be
34.8 parts per billion (ppb) for surface
water and 2.05 ppb for ground water.
EDWCs for chronic exposures for noncancer assessments are estimated to be
24.7 ppb for surface water and 1.80 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 34.8 ppb was
used to assess the contribution to
drinking water. For chronic dietary risk
assessment, the water concentration
value of 24.7 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 currently registered for
the following uses that could result in
residential exposures: Ornamental
plants. EPA assessed residential
exposure using the following
assumptions: Only short-term inhalation
exposures to adult residential handlers
from application to ornamental plants.
Though there may be short-term dermal
exposures to handlers, this was not
assessed since no dermal endpoint was
identified. Post-application exposures to
adults and children are not expected.
Intermediate or chronic exposures are
not expected. Further information
regarding EPA standard assumptions
and generic inputs for residential
exposures may be found at https://
www2.epa.gov/pesticide-science-andassessing-pesticide-risks/standard-
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operating-procedures-residentialpesticide.
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 engendered 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 https://
www2.epa.gov/pesticide-science-andassessing-pesticide-risks/cumulativeassessment-risk-pesticides.
D. Safety Factor for Infants and
Children
1. In general. Section 408(b)(2)(C) of
FFDCA provides that EPA shall apply
an additional tenfold (10X) margin of
safety for infants and children in the
case of threshold effects to account for
prenatal and postnatal toxicity and the
completeness of the database on toxicity
and exposure unless EPA determines
based on reliable data that a different
margin of safety will be safe for infants
and children. This additional margin of
safety is commonly referred to as the
Food Quality Protection Act Safety
Factor (FQPA 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.
In a rat developmental toxicity study,
there were significantly lower mean
fetal weights in the high-dose group
compared to controls as well as a
significant increase in skeletal
anomalies in the high-dose group due to
abnormal ossification. The skeletal
anomalies/variations were considered to
be a transient developmental delay that
occurs secondary to the maternal
toxicity noted in the high-dose group. In
the rabbit study, the only treatment
related developmental effect was
indication of an increased incidence of
a 13th rib at maternally toxic doses.
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Signs of fetal effects in the reproductive
toxicity study included significantly
lower F1 and F2 pup weights in the
high-dose group during lactation, which
continued to be lower than controls
post-weaning and after the pre-mating
period in the F1 generation only.
Reproductive effects were seen only at
doses that also caused parental toxicity.
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 for non-inhalation
routes of exposure and retained at 10X
for inhalation exposure scenarios for all
population groups. That decision is
based on the following findings:
i. The toxicity database for cyprodinil
is complete, except for a 90-day
inhalation toxicity study required to
reduce uncertainty associated with the
use of an oral POD for assessing risk via
the inhalation route. In the absence of
a route-specific inhalation study, a 10x
FQPA SF factor for residential scenarios
will be retained for risk assessments
involving inhalation exposure.
ii. As indicated by an acute
neurotoxicity study in mice, clinical
signs, hypothermia, and changes in
motor activity were all found to be
reversible and no longer seen at day 8
and 15 investigations. There were no
treatment related effects on mortality,
gross or histological neuropathology.
Reduced motor activity, induced
hunched posture, piloerection and
reduced responsiveness to sensory
stimuli were observed and disappeared
in all animals by day 3 to 4. In a subchronic neurotoxicity study in rats,
there were no treatment related effects
on mortality, clinical signs, or gross or
histological neuropathology. No clinical
signs suggestive of neurobehavioral
alterations or evidence of
neuropathological effects were observed
in the available oral-toxicity studies.
Based on this evidence, there is no need
for a developmental neurotoxicity study
or additional uncertainty factors (UFs)
to account for neurotoxicity.
iii. In the prenatal developmental rat
and rabbit studies and in the 2generation reproduction rat study,
toxicity to the fetuses/offspring, when
observed, occurred at the same doses at
which effects were observed in
maternal/parental animals. All of these
fetal effects were considered to be
secondary to maternal toxicity. 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 2generation reproduction study.
iv. There are no residual uncertainties
identified in the exposure databases.
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The acute dietary assessment was
conservative and based on 100 PCT and
tolerance level residues as well as
DEEM default and empirical processing
factors. The chronic dietary assessment
was partially refined with average field
trial residues for some commodities and
tolerance-level residues for the
remaining commodities. DEEM default
and empirical processing factors were
also incorporated into the chronic
dietary assessment. EPA made
conservative (protective) assumptions in
the ground and surface water modeling
used to assess exposure to cyprodinil in
drinking water. Based on the discussion
in Unit III.C.3, post-application
exposure to children as well as
incidental oral exposure to toddlers is
not expected. 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 8.6% of the
aPAD for children one to two 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 85% of
the cPAD for children one to two years
old, the population group receiving the
greatest exposure. Based on the
explanation in Unit III.C.3., regarding
residential use patterns, chronic
residential exposure to residues of
cyprodinil is not expected.
3. Short-term risk. Short-term
aggregate exposure takes into account
short-term residential exposure plus
chronic exposure to food and water
(considered to be a background
exposure level). Cyprodinil is currently
registered for uses that could result in
short-term residential exposure, and the
Agency has determined that it is
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appropriate to aggregate chronic
exposure through food and water with
short-term residential exposures to
cyprodinil. Using the exposure
assumptions described in this unit for
short term exposures, EPA has
estimated short-term food, water and
residential exposures. For adults, oral
dietary and inhalation estimates were
combined using the total aggregate risk
index (ARI) methodology since the
levels of concern (LOC) for oral and
dietary exposure (LOC=100) and
inhalation (LOC 1,000) are different.
The short-term ARI for adults is 70
which is greater than 1 and is therefore,
not of concern.
4. Intermediate-term risk.
Intermediate-term aggregate exposure
takes into account intermediate-term
residential exposure plus chronic
exposure to food and water (considered
to be a background exposure level). An
intermediate-term adverse effect was
identified; however, cyprodinil is not
registered for any use patterns that
would result in intermediate-term
residential exposure. Intermediate-term
risk is assessed based on intermediateterm residential exposure plus chronic
dietary exposure. Because there is no
intermediate-term residential exposure
and chronic dietary exposure has
already been assessed under the
appropriately protective cPAD (which is
at least as protective as the POD used to
assess intermediate-term risk), no
further assessment of intermediate-term
risk is necessary, and EPA relies on the
chronic dietary risk assessment for
evaluating intermediate-term risk for
cyprodinil.
5. 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.
6. Determination of safety. Based on
these risk assessments, EPA concludes
that there is a reasonable certainty that
no harm will result to the general
population, or to infants and children
from aggregate exposure to cyprodinil
residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate HPLC/UV methods (AG–
631 and AG–631B) are available for
enforcing tolerances of cyprodinil on
plant commodities.
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;
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Federal Register / Vol. 81, No. 75 / Tuesday, April 19, 2016 / Rules and Regulations
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
(MRLs) established by the Codex
Alimentarius Commission (Codex), as
required by FFDCA section 408(b)(4).
The Codex Alimentarius is a joint
United Nations 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 not established an
MRL for cyprodinil in/on tree nut
commodities other than pistachio and
almond.
V. Conclusion
Therefore, tolerances are established
for residues of cyprodinil, in or on Nut,
Tree Crop Group 14–12; except almond
and pistachio at 0.04 ppm.
VI. Statutory and Executive Order
Reviews
This action establishes tolerances
under FFDCA section 408(d) 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 action
has been exempted from review under
Executive Order 12866, this action 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 action 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 FFDCA section 408(d), 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 action 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 FFDCA
section 408(n)(4). 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 action. In addition, this action
does not impose any enforceable duty or
contain any unfunded mandate as
described under Title II of the Unfunded
Mandates Reform Act (UMRA) (2 U.S.C.
1501 et seq.).
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
(NTTAA) (15 U.S.C. 272 note).
VII. Congressional Review Act
Pursuant to the Congressional Review
Act (5 U.S.C. 801 et seq.), 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 the rule in the Federal
Register. This action 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 7, 2016.
Daniel J. Rosenblatt,
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 § 180.532, add alphabetically the
commodity ‘‘Nut, tree, group 14–12;
except almond and pistachio’’ to the
table in paragraph (a), to read as follows:
■
§ 180.532 Cyprodinil; tolerances for
residues.
(a) * * * (1) * * *
Parts per
million
Commodity
*
*
*
*
*
*
Nut, tree, group 14–12; except almond and pistachio ........................................................................................................................
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This action increases the trip
limit for Gulf of Maine cod, Gulf of
Maine haddock, and Southern New
England/Mid-Atlantic yellowtail
flounder for Northeast multispecies
common pool vessels for the remainder
of the 2015 fishing year. The regulations
authorize the Regional Administrator to
adjust the trip limits for common pool
vessels in order to facilitate harvest of,
or prevent exceeding, the pertinent
common pool quotas during the fishing
year. Increasing these trip limits is
intended to provide additional fishing
opportunities and help allow the
common pool fishery to catch its
allowable quota for this stock.
DATES: The trip limit increase is
effective April 14, 2016, through April
30, 2016.
FOR FURTHER INFORMATION CONTACT:
Sarah Heil, Supervisory Fishery Policy
Analyst, 978–281–9257.
SUPPLEMENTARY INFORMATION: The
regulations at § 648.86(o) authorize the
SUMMARY:
[FR Doc. 2016–09028 Filed 4–18–16; 8:45 am]
BILLING CODE 6560–50–P
DEPARTMENT OF COMMERCE
National Oceanic and Atmospheric
Administration
50 CFR Part 648
[Docket No. 150105004–5355–01]
RIN 0648–XE569
Fisheries of the Northeastern United
States; Northeast Multispecies
Fishery; Trip Limit Adjustment for the
Common Pool Fishery
National Marine Fisheries
Service (NMFS), National Oceanic and
Atmospheric Administration (NOAA),
Commerce.
ACTION: Temporary rule; inseason
adjustment.
AGENCY:
22919
Regional Administrator (RA) to adjust
the possession limits for common pool
vessels in order to prevent the
overharvest or underharvest of the
common pool quotas. As of April 5,
2016, the common pool had caught
approximately 61 percent of its annual
quota of Gulf of Maine (GOM) cod, 11
percent of its GOM haddock quota, and
88 percent of its Southern New
England/Mid-Atlantic (SNE/MA)
yellowtail flounder quota. To allow the
common pool fishery to catch more of
its quota for these stocks, effective April
14, 2016, the trip limits for GOM cod,
GOM haddock, and SNE/MA yellowtail
flounder for all common pool vessels
are increased as summarized in Table 1.
These changes are intended to provide
additional fishing opportunities for
common pool vessels.
TABLE 1—FISHING YEAR 2015 COMMON POOL TRIP LIMIT INCREASES
Stock
Current possession/trip limit
New possession/trip limit
GOM Cod ......................................
GOM Haddock ..............................
25 lb (11.3 kg) per trip ................................................
50 lb (22.7 kg) per DAS up to 200 lb (90.7 kg) per
trip.
50 lb (22.7 kg) per trip ................................................
100 lb (45.4 kg) per trip.
500 lb (226.8 kg) per DAS up to 1,000 lb (453.6 kg)
per trip.
500 lb (226.8 kg) per DAS up to 1,000 lb (453.6 kg)
per trip.
SNE/MA Yellowtail Flounder .........
Weekly quota monitoring reports for
the common pool fishery can be found
on our Web site at: https://
www.greateratlantic.fisheries.noaa.gov/
ro/fso/MultiMonReports.htm. We will
continue to monitor common pool catch
through vessel trip reports, dealerreported landings, vessel monitoring
system catch reports, and other
available information and, if necessary,
we will make additional adjustments to
common pool management measures.
Classification
jstallworth on DSK7TPTVN1PROD with RULES
This action is required by 50 CFR part
648 and is exempt from review under
Executive Order 12866.
The Assistant Administrator for
Fisheries, NOAA, finds good cause
pursuant to 5 U.S.C. 553(b)(B) and 5
U.S.C. 553(d)(3) to waive prior notice
and the opportunity for public comment
and the 30-day delayed effectiveness
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period because it would be
impracticable and contrary to the public
interest.
The regulations at § 648.86(o)
authorize the RA to adjust the Northeast
multispecies possession and trip limits
for common pool vessels in order to
prevent the overharvest or underharvest
of the pertinent common pool subACLs. The catch data used to justify
increasing the possession and trip limit
for GOM cod, GOM haddock, and SNE/
MA yellowtail flounder only recently
became available. The possession and
trip limit increase implemented through
this action allows for increased harvest
of these stocks, to help ensure that the
fishery may achieve optimum yield. As
a result, the time necessary to provide
for prior notice and comment, and a 30day delay in effectiveness, would
prevent us from increasing the
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possession and trip limit for these
stocks before the end of the fishing year
on April 30, 2016, which would prevent
the additional fishing opportunities this
action is intended to provide. This
would undermine management
objectives of the Northeast Multispecies
Fishery Management Plan and cause
unnecessary negative economic impacts
to the common pool fishery. There is
additional good cause to waive the
delayed effective period because this
action relieves restrictions on fishing
vessels by increasing a trip limit.
Authority: 16 U.S.C. 1801 et seq.
Dated: April 14, 2016.
Alan D. Risenhoover,
Director, Office of Sustainable Fisheries,
National Marine Fisheries Service.
[FR Doc. 2016–09016 Filed 4–14–16; 4:15 pm]
BILLING CODE 3510–22–P
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Agencies
[Federal Register Volume 81, Number 75 (Tuesday, April 19, 2016)]
[Rules and Regulations]
[Pages 22914-22919]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-09028]
=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2015-0180; FRL-9943-85]
Cyprodinil; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes tolerances for residues of
cyprodinil in or on Nut, Tree, Crop Group 14-12; except almond and
pistachio. Syngenta Crop Protection, LLC requested these tolerances
under the Federal Food, Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective April 19, 2016. Objections and
requests for hearings must be received on or before June 20, 2016, 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: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2015-0180, is available at https://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is (202) 566-1744, and the telephone number for the OPP
Docket is (703) 305-5805. Please review the visitor instructions and
additional information about the docket available at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Susan Lewis, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone
number: (703) 305-7090; email address: RDFRNotices@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.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
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.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.
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-2015-0180 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 20, 2016. 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 (excluding any Confidential Business Information (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 the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2015-0180, by one of
the following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at https://www.epa.gov/dockets/contacts.html.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at https://www.epa.gov/dockets.
II. Summary of Petitioned-for Tolerance
In the Federal Register of April 22, 2015 (80 FR 22466) (FRL-9925-
79), EPA issued a document pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
4F8333) by Syngenta Crop Protection, LLC, P.O. Box 18300, Greensboro,
NC 27419-8300. The petition requested that 40 CFR 180.532 be amended by
establishing tolerances for residues of the fungicide cyprodinil, 4-
cyclopropyl-6-methyl-N-phenyl-2-pyrimidinamine, in or on Nut, Tree,
Crop Group 14-12; except almond and pistachio at 0.04 parts per million
(ppm). That document referenced a summary of the petition prepared by
Syngenta Crop Group, LLC, the registrant, which is available in the
docket, https://www.regulations.gov. Comments were received on the
notice of filing. EPA's response to these comments is discussed 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
[[Page 22915]]
result to infants and children from aggregate exposure to the pesticide
chemical residue. . . .''
Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), 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.
The major target organs of cyprodinil are the liver and the kidney.
Liver effects were consistent among male and female rats and mice in
both sub-chronic and chronic studies and typically included increased
liver weights along with increases in serum clinical chemistry
parameters associated with adverse effects on liver function (i.e.,
increased cholesterol and phospholipid levels). Microscopic lesions in
rats and mice included hepatocyte hypertrophy and hepatocellular
necrosis. In the kidneys, adverse effects were seen as chronic tubular
lesions and chronic kidney inflammation following sub-chronic exposure
of male rats. Chronically, cyprodinil caused increased kidney weights
and progressive nephropathy in male rats. Chronic effects in dogs were
limited to decreased body-weight gain, decreased food consumption and
decreased food efficiency; liver toxicity was not seen in the dog. The
hematopoietic system also appeared to be a target of cyprodinil as mild
anemia was seen in rats exposed sub-chronically (reductions in
hematocrit and hemoglobin and microcytosis). Although increases in
thyroid weight and/or hypertrophy of thyroid follicular cells were
observed at higher doses in the rat 28-day oral-toxicity studies and in
the 90-day oral-toxicity study in rats, treatment related changes in
thyroid weights or gross/microscopic observations were not observed in
the chronic rat study or in other studies.
A 28-day dietary immunotoxicity study in mice resulted in no
apparent suppression of the humoral component of the immune system. The
only effect attributed to cyprodinil treatment was higher mean
absolute, relative (to body weight), and adjusted liver weights for the
5000 ppm group. 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 Immunoglobulin M antibody-forming
cells to the T cell-dependent red blood cell antigens. No dermal or
systemic toxicity was seen following repeated dermal application at the
highest dose in a 21-day dermal toxicity study in rabbits.
An acute neurotoxicity study indicated systemic toxicity with signs
of induced hunched posture, piloerection, and reduced responsiveness to
sensory stimuli and reduced motor activity. Females were slightly more
affected than males per daily clinical observations, which disappeared
by day 3 to 4. A dose-related reduction in body temperature was seen in
all treated animals, thus hypothermia is considered a compound-related
effect in the highest dose tested and was found to be statistically
significant, whereas the lower dosed animals was not or only marginally
significant and was fully reversible in all groups. Clinical signs,
hypothermia, and changes in motor activity were found to all be
reversible by day 8 and 15 investigations. There were no
histopathological findings to support evidence of damage to the central
nervous system, eyes, optic nerves, or skeletal muscles. A sub-chronic
neurotoxicity study showed no treatment related effects on mortality,
clinical signs, or gross or histological neuropathology. Functional
observational battery and motor activity testing revealed no treatment
related effects up to the highest dose tested.
There was no evidence of increased susceptibility in the
developmental rat or rabbit study following in utero exposure or in the
two-generation reproduction study following pre- and post-natal
exposure. Fetal toxicity, manifested as significantly lower fetal
weights and an increased incidence of delayed ossification in the rat
and a slight increase in litters showing extra ribs (13th) in the
rabbit, was reported in developmental toxicity studies. In a rat two-
generation reproduction study, significantly lower pup weights for
F1 and F2 offspring were observed. However, each
of these fetal/neonatal effects occurred at the same dose levels at
which maternal toxicity (decreased body weight gain) was observed and
were considered to be secondary to maternal toxicity.
Based on the lack of evidence of carcinogenicity in mice and rats
at doses that were judged to be adequate to the carcinogenic potential,
cyprodinil was classified as ``not likely to be carcinogenic to
humans.''
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 the document, ``Human Health Risk Assessment for
the Petition Proposing a New Tolerance for the Use of cyprodinil in/on
Nut, Tree, Crop Group 14-12; except almond and pistachio'' in docket ID
number EPA-HQ-OPP-2015-0180.
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 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 the NOAEL and the LOAEL are identified.
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://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
A summary of the toxicological endpoints for cyprodinil used for
human risk assessment is discussed in Unit III.B. of the final rule
published in the Federal Register of October 16, 2012 (77 FR 49732)
(FRL-9359-7).
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to cyprodinil, EPA considered exposure under the petitioned-
for
[[Page 22916]]
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. EPA used food consumption information from the United
States Department of Agriculture (USDA) National Health and Nutrition
Examination Survey, What We Eat in America, (NHANES/WWEIA). This
dietary survey was conducted from 2003 to 2008. As to residue levels in
food, EPA utilized the Dietary Exposure Evaluation Model software with
the Food Commodity Intake Database DEEM-FCID, Version 3.16 default
processing factors and tolerance-level residues and 100 percent crop
treated (PCT) for all commodities.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used food consumption information from the USDA NHANES/
WWEIA dietary survey conducted from 2003 to 2008. As to residue levels
in food, EPA utilized residue data from field trials to obtain average
residues and assumed 100 PCT. Empirically derived processing factors
were used in these assessments when available; all other processing
factors used the DEEM-FCID Version 7.81 default processing factors.
iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that cyprodinil does not pose a cancer risk to humans.
Therefore, a dietary exposure assessment for the purpose of assessing
cancer risk was not conducted.
iv. Anticipated residue 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 and CGA 249287 in drinking water. These
simulation models take into account data on the physical, chemical, and
fate/transport characteristics of cyprodinil and CGA 249287. Further
information regarding EPA drinking water models used in pesticide
exposure assessment can be found at https://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
Based on the Pesticide Root Zone Model/Exposure Analysis Modeling
System (PRZM/EXAMS), Screening Concentration in Ground Water (SCI-GROW)
models and Pesticide Root Zone Model Ground Water (PRZM GW), the
estimated drinking water concentrations (EDWCs) of cyprodinil and CGA
249287 for acute exposures are estimated to be 34.8 parts per billion
(ppb) for surface water and 2.05 ppb for ground water. EDWCs for
chronic exposures for non-cancer assessments are estimated to be 24.7
ppb for surface water and 1.80 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 34.8 ppb was used to
assess the contribution to drinking water. For chronic dietary risk
assessment, the water concentration value of 24.7 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 currently registered for the following uses that
could result in residential exposures: Ornamental plants. EPA assessed
residential exposure using the following assumptions: Only short-term
inhalation exposures to adult residential handlers from application to
ornamental plants. Though there may be short-term dermal exposures to
handlers, this was not assessed since no dermal endpoint was
identified. Post-application exposures to adults and children are not
expected. Intermediate or chronic exposures are not expected. Further
information regarding EPA standard assumptions and generic inputs for
residential exposures may be found at https://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide.
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 engendered 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 https://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.
D. Safety Factor for Infants and Children
1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the Food Quality
Protection Act Safety Factor (FQPA 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. In a rat developmental
toxicity study, there were significantly lower mean fetal weights in
the high-dose group compared to controls as well as a significant
increase in skeletal anomalies in the high-dose group due to abnormal
ossification. The skeletal anomalies/variations were considered to be a
transient developmental delay that occurs secondary to the maternal
toxicity noted in the high-dose group. In the rabbit study, the only
treatment related developmental effect was indication of an increased
incidence of a 13th rib at maternally toxic doses.
[[Page 22917]]
Signs of fetal effects in the reproductive toxicity study included
significantly lower F1 and F2 pup weights in the
high-dose group during lactation, which continued to be lower than
controls post-weaning and after the pre-mating period in the
F1 generation only. Reproductive effects were seen only at
doses that also caused parental toxicity.
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 for non-inhalation routes of exposure and
retained at 10X for inhalation exposure scenarios for all population
groups. That decision is based on the following findings:
i. The toxicity database for cyprodinil is complete, except for a
90-day inhalation toxicity study required to reduce uncertainty
associated with the use of an oral POD for assessing risk via the
inhalation route. In the absence of a route-specific inhalation study,
a 10x FQPA SF factor for residential scenarios will be retained for
risk assessments involving inhalation exposure.
ii. As indicated by an acute neurotoxicity study in mice, clinical
signs, hypothermia, and changes in motor activity were all found to be
reversible and no longer seen at day 8 and 15 investigations. There
were no treatment related effects on mortality, gross or histological
neuropathology. Reduced motor activity, induced hunched posture,
piloerection and reduced responsiveness to sensory stimuli were
observed and disappeared in all animals by day 3 to 4. In a sub-chronic
neurotoxicity study in rats, there were no treatment related effects on
mortality, clinical signs, or gross or histological neuropathology. No
clinical signs suggestive of neurobehavioral alterations or evidence of
neuropathological effects were observed in the available oral-toxicity
studies. Based on this evidence, there is no need for a developmental
neurotoxicity study or additional uncertainty factors (UFs) to account
for neurotoxicity.
iii. In the prenatal developmental rat and rabbit studies and in
the 2-generation reproduction rat study, toxicity to the fetuses/
offspring, when observed, occurred at the same doses at which effects
were observed in maternal/parental animals. All of these fetal effects
were considered to be secondary to maternal toxicity. 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 assessment was conservative and based on
100 PCT and tolerance level residues as well as DEEM default and
empirical processing factors. The chronic dietary assessment was
partially refined with average field trial residues for some
commodities and tolerance-level residues for the remaining commodities.
DEEM default and empirical processing factors were also incorporated
into the chronic dietary assessment. EPA made conservative (protective)
assumptions in the ground and surface water modeling used to assess
exposure to cyprodinil in drinking water. Based on the discussion in
Unit III.C.3, post-application exposure to children as well as
incidental oral exposure to toddlers is not expected. 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 8.6% of the aPAD for children one to two
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 85% of the cPAD for
children one to two years old, the population group receiving the
greatest exposure. Based on the explanation in Unit III.C.3., regarding
residential use patterns, chronic residential exposure to residues of
cyprodinil is not expected.
3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level). Cyprodinil is
currently registered for uses that could result in short-term
residential exposure, and the Agency has determined that it is
appropriate to aggregate chronic exposure through food and water with
short-term residential exposures to cyprodinil. Using the exposure
assumptions described in this unit for short term exposures, EPA has
estimated short-term food, water and residential exposures. For adults,
oral dietary and inhalation estimates were combined using the total
aggregate risk index (ARI) methodology since the levels of concern
(LOC) for oral and dietary exposure (LOC=100) and inhalation (LOC
1,000) are different. The short-term ARI for adults is 70 which is
greater than 1 and is therefore, not of concern.
4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level). An intermediate-term adverse effect was identified; however,
cyprodinil is not registered for any use patterns that would result in
intermediate-term residential exposure. Intermediate-term risk is
assessed based on intermediate-term residential exposure plus chronic
dietary exposure. Because there is no intermediate-term residential
exposure and chronic dietary exposure has already been assessed under
the appropriately protective cPAD (which is at least as protective as
the POD used to assess intermediate-term risk), no further assessment
of intermediate-term risk is necessary, and EPA relies on the chronic
dietary risk assessment for evaluating intermediate-term risk for
cyprodinil.
5. 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.
6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to cyprodinil residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate HPLC/UV methods (AG-631 and AG-631B) are available for
enforcing tolerances of cyprodinil on plant commodities.
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;
[[Page 22918]]
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 (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
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 not established an MRL for cyprodinil in/on tree nut
commodities other than pistachio and almond.
V. Conclusion
Therefore, tolerances are established for residues of cyprodinil,
in or on Nut, Tree Crop Group 14-12; except almond and pistachio at
0.04 ppm.
VI. Statutory and Executive Order Reviews
This action establishes tolerances under FFDCA section 408(d) 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 action has been
exempted from review under Executive Order 12866, this action 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 action 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 FFDCA section 408(d), 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 action 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 FFDCA section 408(n)(4). 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 action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(UMRA) (2 U.S.C. 1501 et seq.).
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 (NTTAA) (15 U.S.C. 272 note).
VII. Congressional Review Act
Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
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
the rule in the Federal Register. This action 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 7, 2016.
Daniel J. Rosenblatt,
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. In Sec. 180.532, add alphabetically the commodity ``Nut, tree,
group 14-12; except almond and pistachio'' to the table in paragraph
(a), to read as follows:
Sec. 180.532 Cyprodinil; tolerances for residues.
(a) * * * (1) * * *
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * * * *
Nut, tree, group 14-12; except almond and pistachio..... 0.04
* * * * * * *
------------------------------------------------------------------------
[[Page 22919]]
* * * * *
[FR Doc. 2016-09028 Filed 4-18-16; 8:45 am]
BILLING CODE 6560-50-P