[Federal Register Volume 77, Number 160 (Friday, August 17, 2012)]
[Rules and Regulations]
[Pages 49732-49738]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-20235]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2011-0394; FRL-9359-7]
Cyprodinil; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for residues of
cyprodinil in or on multiple commodities which are identified and
discussed later in this document, associated with Pesticide Petition
(PP) 1E7854, and establishes a tolerance in or on leaf petioles
subgroup 4B, associated with PP 1E7869. Interregional Research Project
Number 4 (IR-4) and Syngenta Crop Protection requested the tolerances
associated with PP 1E7854 and 1E7869, respectively, under the Federal
Food, Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective August 17, 2012. Objections and
requests for hearings must be received on or before October 16, 2012,
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-2011-0394, is available either
electronically through http://www.regulations.gov or in hard copy at
the OPP Docket in the Environmental Protection Agency Docket Center
(EPA/DC), located in EPA West, 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 http://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Laura Nollen, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone
number: (703) 305-7390; email address: [email protected].
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
[[Page 49733]]
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).
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 http://ecfr.gpoaccess.gov/cgi/t/text/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-2011-0394 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
October 16, 2012. Addresses for mail and hand delivery of objections
and hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket. Information not marked confidential pursuant to 40 CFR part 2
may be disclosed publicly by EPA without prior notice. Submit a copy of
your non-CBI objection or hearing request, identified by docket ID
number EPA-HQ-OPP-2011-0394, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute.
Mail: OPP Docket, Environmental Protection
Agency Docket Center (EPA/DC), Mail Code: 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 http://www.epa.gov/dockets/contacts.htm.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.
II. Summary of Petitioned-For Tolerance
In the Federal Register of July 20, 2011 (76 FR 43231) (FRL-8880-
1), EPA issued a notice pursuant to FFDCA section 408(d)(3), 21 U.S.C.
346a(d)(3), announcing the filing of PP 1E7854 by IR-4, 500 College
Road East, Suite 201W, Princeton, NJ 08540. 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 onion, bulb, subgroup 3-07A at 0.6 parts per
million (ppm); onion, green, subgroup 3-07B at 4.0 ppm; caneberry
subgroup 13-07A at 10.0 ppm; bushberry subgroup 13-07B at 3.0 ppm;
fruit, small vine climbing, except fuzzy kiwifruit, subgroup 13-07F at
2.0 ppm; berry, low growing, subgroup 13-07G, except cranberry at 5.0
ppm; dragon fruit at 2.0 ppm; fruit, pome, group 11-10 at 1.7 ppm;
vegetable, fruiting, group 8-10 at 1.3 ppm; and leafy greens subgroup
4A at 40 ppm.
Upon approval of the aforementioned tolerances, the petition
additionally requested amendment of 40 CFR 180.532 by removing the
established tolerances for the residues of cyprodinil in or on onion,
bulb at 0.60 ppm; onion, green at 4.0 ppm; caneberry subgroup 13A at 10
ppm; bushberry subgroup 13B at 3.0 ppm; Juneberry at 3.0 ppm;
lingonberry at 3.0 ppm; salal at 3.0 ppm; grape at 2.0 ppm; strawberry
at 5.0 ppm; fruit, pome at 1.7 ppm; tomatillo at 0.45 ppm; tomato at
0.45 ppm; and leafy greens subgroup 4A, except spinach at 30 ppm. The
published notice of the petition referenced a summary of the petition
prepared on behalf of IR-4 by Syngenta Crop Protection, Inc., the
registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to
this notice of filing.
In the Federal Register of April 4, 2012 (77 FR 20334) (FRL-9340-
4), EPA issued a notice pursuant to FFDCA section 408(d)(3), 21 U.S.C.
346a(d)(3), announcing the filing of PP 1E7869 by Syngenta Crop
Protection, 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 leafy petioles subgroup
4B at 30 parts per million. That notice referenced a summary of the
petition prepared by Syngenta Crop Protection, Inc., the registrant,
which is available in the docket, http://www.regulations.gov. One
comment was received to this notice of filing. EPA's response to the
comment is discussed in Unit IV.C.
Based upon review of the data supporting the petitions, EPA has
revised the proposed tolerance levels for several commodities. The
reasons for these changes are explained in Unit IV.D.
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 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
[[Page 49734]]
subgroups of consumers, including infants and children.
Cyprodinil has low acute toxicity via the oral, dermal, and
inhalation routes of exposure. 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 included increased
liver weights and increases in serum clinical chemistry parameters
associated with adverse effects on liver function, hepatocyte
hypertrophy, and hepatocellular necrosis. Adverse kidney effects
included tubular lesions and inflammation following subchronic exposure
of male rats. The hematopoietic system also appeared to be a target of
cyprodinil, causing mild anemia following subchronic exposure to
cyprodinil in rats. Chronic effects in dogs were limited to decreased
body weight gain, decreased food consumption and decreased food
efficiency.
Fetal toxicity reported in developmental toxicity studies in the
rat included significantly lower fetal weights and an increased
incidence of delayed ossification in the rat and showed a slight
increase in litters showing extra ribs in the rabbit. In a rat 2-
generation reproduction study, significantly lower pup weights were
observed in F1 and F2 offspring. However, each of
these fetal and neonatal effects occurred at the same dose levels at
which maternal toxicity (decreased body weight gain) was observed, and
the effects were considered to be secondary to maternal toxicity.
In an acute neurotoxicity study in rats, 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. The subchronic
neurotoxicity study in rats, showed no treatment-related effects
related to neurotoxicity. An immunotoxicity study in mice resulted in
no apparent suppression of the humoral component of the immune system.
There was no evidence of carcinogenic potential in either the rat
chronic toxicity/carcinogenicity or mouse carcinogenicity studies.
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 http://www.regulations.gov in document: ``Cyprodinil: Expansions of Existing
Crop Group/Representative Commodity Uses to Numerous Crop Subgroups,
Adding Use on Leafy Petiole Subgroup 4B, and Adding Use on the
Remaining Crops in Fruiting Vegetables Group 8-10.'' pp 34-38 in docket
ID number EPA-HQ-OPP-2011-0394.''
B. Toxicological Points of Departure/Levels of Concern
Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern (LOC) to use in evaluating the risk posed by human exposure to
the pesticide. For hazards that have a threshold below which there is
no appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors (U/SF) 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 http://www.epa.gov/pesticides/factsheets/riskassess.htm. A summary of the
toxicological endpoints for cyprodinil used for human risk assessment
is shown in Table 1 of this unit.
Table 1--Summary of Toxicological Doses and Endpoints for Cyprodinil for Use in Human Health Risk Assessment
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Point of departure
Exposure/scenario and uncertainty/ RfD, PAD, LOC for Study and toxicological effects
safety factors risk assessment
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Acute dietary All populations)... NOAEL = 200 mg/kg/ Acute RfD = 2.0 mg/ Acute Neurotoxicity--Rat LOAEL =
day. kg/day. 600 mg/kg/day based on clinical
UFA = 10x........... aPAD = 2.0 mg/kg/ signs of toxicity (hunched
UFH = 10x........... day. posture, piloerection, and
FQPA SF = 1x........ reduced responsiveness to sensory
stimuli, reduced motor activity
and hypothermia).
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Chronic dietary (All populations) NOAEL = 2.7 mg/kg/ Chronic RfD = 0.027 2-Year Chronic Toxicity/
day. mg/kg/day. Carcinogenicity--rat LOAEL = 35.6
UFA = 10x........... cPAD = 0.027 mg/kg/ mg/kg/day based on degenerative
UFH = 10x........... day. liver lesions (spongiosis
FQPA SF = 1x........ hepatitis) in males.
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[[Page 49735]]
Inhalation short-term (1 to 30 Inhalation (or oral) LOC for MOE = 1,000 28-Day Feeding/Range-Finding--Rat
days). study NOAEL= 62 mg/ LOAEL = 299 mg/kg/day based on
kg/day (inhalation decreased body-weight gain,
absorption rate = increased cholesterol and
100%). phospholipid levels,
UFA = 10x........... microcytosis, and hepatocyte
UFH = 10x........... hypertrophy.
FQPA SF = 10x.......
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Cancer (Oral, dermal, inhalation) Not likely to be carcinogenic to humans.
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FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor.
UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among
members of the human population (intraspecies).
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.
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
assumed tolerance-level residues, 100 percent crop treated (PCT)
estimates, and Dietary Exposure Evaluation Model (DEEMTM
(ver. 7.81)) default processing factors.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA 1994-1996
and 1998 CSFII. As to residue levels in food, EPA assumed tolerance-
level residues for most commodities; average field trial residues for
pome fruit, head lettuce, leaf lettuce, and grapes; and 100 PCT
estimates. DEEMTM (ver. 7.81) default and empirical
processing factors for tomato paste/puree (1x) and lemon/lime juice
(1x) were used to modify the tolerance values.
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 is unnecessary.
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 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 http://www.epa.gov/oppefed1/models/water/index.htm.
Based on the Pesticide Root Zone Model/Exposure Analysis Modeling
System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI-
GROW) models, the estimated drinking water concentrations (EDWCs) of
cyprodinil for surface water are expected to be 34.79 parts per billion
(ppb) for acute exposures and 24.65 ppb for chronic exposures. The
EDWCs of cyprodinil for ground water are expected to be 0.0861 ppb for
acute and chronic 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 34.79 ppb was used to
assess the contribution to drinking water. For chronic dietary risk
assessment, the water concentration of value 24.65 ppb was used to
assess the contribution to drinking water.
3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets). Cyprodinil is
currently registered for the following uses that could result in
residential exposures: Ornamental landscapes. EPA assessed residential
exposure using the following assumptions: Short-term inhalation
exposures to residential handlers are expected from application to
ornamental landscapes. Dermal exposures were not assessed, since there
is no dermal POD. Residential handler exposure scenarios are considered
to be short-term only, due to the infrequent use patterns associated
with homeowner products. Postapplication exposures are not expected.
Further information regarding EPA standard assumptions and generic
inputs for residential exposures may be found at http://www.epa.gov/pesticides/trac/science/trac6a05.pdf.
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA
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requires that, when considering whether to establish, modify, or revoke
a tolerance, the Agency consider ``available information'' concerning
the cumulative effects of a particular pesticide's residues and ``other
substances that have a common mechanism of toxicity.''
EPA has not found cyprodinil to share a common mechanism of
toxicity with any other substances, and cyprodinil does not appear to
produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
cyprodinil does not have a common mechanism of toxicity with other
substances. For information regarding EPA's efforts to determine which
chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.
D. Safety Factor for Infants and Children
1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA SF. In
applying this provision, EPA either retains the default value of 10X,
or uses a different additional safety factor when reliable data
available to EPA support the choice of a different factor.
2. Prenatal and postnatal sensitivity. The cyprodinil toxicity
database is adequate to evaluate potential increased susceptibility of
infants and children, and includes developmental toxicity studies in
rats and rabbits and a 2-generation reproduction study in rats. 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 occurred
secondary to the maternal toxicity noted in the high dose group. In the
rabbit study, the only treatment related developmental effect was the
indication of an increased incidence of a 13th rib at maternally toxic
doses. 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.
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 exposure scenarios. For
inhalation exposure scenarios for all population groups, EPA is
retaining a 10X FQPA SF. That decision is based on the following
findings:
i. The toxicity database for cyprodinil is complete except for a
90-day inhalation toxicity study. In the absence of inhalation data,
EPA is relying on an oral study for estimating risk from inhalation
exposures. EPA evaluation of use of oral studies to extrapolate an
inhalation endpoint has shown that such extrapolation may understate
risk. Accordingly, to address the uncertainty caused by extrapolating
an inhalation endpoint from an oral study for cyprodinil, EPA has
concluded that the 10X FQPA SF should be retained for risk assessments
involving inhalation exposure.
ii. In the subchronic neurotoxicity study in rats, there was no
indication that cyprodinil is a neurotoxic chemical. In an acute
neurotoxicity study in rats, 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 or 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. Based on this evidence, there is no need for a
developmental neurotoxicity study or additional UFs to account for
neurotoxicity.
iii. In the prenatal developmental toxicity studies in rats and
rabbits and the 2-generation reproduction study in rats, toxicity to
the fetuses and/or offspring, when observed, occurred at the same doses
at which effects were observed in maternal/parental animals.
Additionally, the skeletal anomalies/variations were considered to be a
transient developmental delay that occurred secondary to the maternal
toxicity noted in the high dose group. Therefore, there is no evidence
that cyprodinil results in increased susceptibility in in utero rats or
rabbits in the prenatal developmental studies or in young rats in the
2-generation reproduction study.
iv. There are no residual uncertainties identified in the exposure
databases. The acute dietary food exposure assessment was performed
based on 100 PCT and tolerance-level residues. The chronic dietary food
exposure assessment was partially refined, assuming average field trial
residues and empirical processing factors for some commodities, and
tolerance level residues and DEEM\TM\ (ver. 7.81) default for the
remaining commodities. 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,
postapplication exposure of children as well as incidental oral
exposure of 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
aPAD and 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. An acute aggregate risk assessment takes into
account acute exposure estimates from dietary consumption of food and
drinking water. Using the exposure assumptions discussed in this unit
for acute exposure, the acute dietary exposure from food and water to
cyprodinil will occupy 8.2% of the aPAD for children 1-2 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 75% of the cPAD for
children 1-2 years old, the population group receiving the greatest
exposure. Based on the explanation in Unit III.C.3., regarding
residential use patterns, chronic residential exposure to residues of
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
[[Page 49737]]
short-term residential exposure to adults, 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 concluded the combined short-term food, water, and
residential exposures result in an aggregate MOE of 9,000. Because
EPA's level of concern for cyprodinil is a MOE of 1,000 or below, these
MOEs are not of concern.
4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level). 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 high performance liquid chromatography, using ultra-violet
detection (HPLC/UV) methods (Methods AG-631 and AG-631B) are available
to enforce the tolerance expression of cyprodinil in/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; email address:
[email protected].
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 established MRLs for cyprodinil in or on several
commodities that are not harmonized with the tolerances being
established in the United States, as follows: Codex MRL on eggplant at
0.2 ppm, pepper at 0.5 ppm, and tomato at 0.5 ppm and U.S. tolerance on
vegetable, fruiting, group 8-10 at 1.5 ppm; Codex MRL on onion, bulb at
0.3 ppm and U. S. tolerance on onion, bulb, subgroup 3-07A at 0.6 ppm;
Codex MRL on black and red raspberry at 0.5 ppm and U.S. tolerance on
caneberry subgroup 13-07A at 10 ppm; Codex MRL on head and leaf lettuce
at 10 ppm and U. S. tolerance on leafy greens subgroup 4A at 50 ppm;
and Codex MRLs on apple at 0.05 ppm and pear at 1 ppm and U. S.
tolerance on fruit, pome, group 11-10 at 1.7 ppm. The United States
tolerance recommendations cannot be harmonized with the Codex MRLs
established for cyprodinil because the residue data supporting the
tolerance necessitate a higher value.
Additionally, Codex has an established MRL on grape at 3 ppm and
dried grapes at 5 ppm. The EPA is establishing the tolerance for fruit,
small vine climbing, except fuzzy kiwifruit, subgroup 13-07F (for which
grape is the representative commodity) at 3 ppm and grape, raisin at 5
ppm in order to harmonize with the Codex MRLs. Codex has not
established MRLs on the other commodities associated with these
petitions.
C. Response to Comments
One comment was received to the Notice of Filing for PP 1E7869,
which requested additional information about the nature of the residue
and the adverse effects noted from exposure to cyprodinil. Specific
information on the nature of the residue, including physical and
chemical characteristics, as well as the adverse effects caused by
cyprodinil from the toxicity studies can be found in the supporting and
related material at http://www.regulations.gov in docket ID number EPA-
HQ-OPP-2011-0394.
D. Revisions to Petitioned-For Tolerances
Based on the data supporting the petitions, EPA has revised the
proposed tolerance on vegetable, fruiting, group 8-10 from 1.3 ppm to
1.5 ppm; and leafy greens subgroup 4A from 40 ppm to 50 ppm. The Agency
revised these tolerance levels based on analysis of the residue field
trial data using the Organization for Economic Co-operation and
Development (OECD) tolerance calculation procedures.
Additionally, the Agency revised the proposed tolerance in or on
fruit, small vine climbing, except fuzzy kiwifruit, subgroup 13-07F
from 2.0 ppm to 3.0 ppm in order to harmonize with the established
Codex MRL on grape at 3 ppm. The Agency has also revised the
established tolerance in or on grape, raisin from 3.0 ppm to 5.0 ppm in
order to align with the Codex MRL on dried grapes at 5 ppm.
EPA determined that the established tolerance on tomato, paste at
1.0 ppm should be removed, as it will be superseded by the tolerance in
or on fruiting vegetable group 8-10 tolerance at 1.5 ppm.
V. Conclusion
Therefore, tolerances are established for residues of cyprodinil,
4-cyclopropyl-6-methyl- N -phenyl-2-pyrimidinamine, in or on onion,
bulb, subgroup 3-07A at 0.6 ppm; onion, green, subgroup 3-07B at 4.0
ppm; caneberry subgroup 13-07A at 10 ppm; bushberry subgroup 13-07B at
3.0 ppm; fruit, small vine climbing, except fuzzy kiwifruit, subgroup
13-07F at 3.0 ppm; grape, raisin at 5.0 ppm; berry, low growing,
subgroup 13-07G, except cranberry at 5.0 ppm; vegetable, fruiting,
group 8-10 at 1.5 ppm; leafy greens subgroup 4A at 50 ppm; fruit, pome,
group 11-10 at 1.7 ppm; dragon fruit at 2.0 ppm; and leaf petioles
subgroup 4B at 30 ppm. Additionally, the established tolerance on
citrus, oil is amended from 340 ppm to 60 ppm. Finally, this regulation
removes tolerances of cyprodinil in or on onion, bulb at 0.60 ppm;
onion, green at 4.0 ppm; caneberry subgroup 13A at 10 ppm; bushberry
subgroup 13B at 3.0 ppm; grape at 2.0 ppm; strawberry at 5.0 ppm;
tomato at 0.45 ppm; Juneberry at 3.0 ppm;
[[Page 49738]]
lingonberry at 3.0 ppm; salal at 3.0 ppm; tomatillo at 0.45 ppm; fruit,
pome at 1.7 ppm; leafy greens subgroup 4A, except spinach at 30 ppm;
and tomato, paste at 1.0 ppm.
VI. Statutory and Executive Order Reviews
This final rule 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 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 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 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 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 final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Pub. L. 104-4).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note).
VII. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and to
the Comptroller General of the United States. EPA will submit a report
containing this rule and other required information to the U.S. Senate,
the U.S. House of Representatives, and the Comptroller General of the
United States prior to publication of this final rule in the Federal
Register. This final rule is not a ``major rule'' as defined by 5
U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: August 10, 2012.
Daniel J. Rosenblatt,
Acting 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, the table in paragraph (a)(1) is revised to read
as follows:
Sec. 180.532 Cyprodinil; tolerances for residues.
(a) * * *
(1) * * *
------------------------------------------------------------------------
Parts
Commodity per
million
------------------------------------------------------------------------
Almond....................................................... 0.02
Almond, hulls................................................ 8.0
Apple, wet pomace............................................ 4.6
Avocado...................................................... 1.2
Bean, dry.................................................... 0.6
Bean, succulent.............................................. 0.6
Berry, low growing, subgroup 13-07G, except cranberry........ 5.0
Brassica, head and stem, subgroup 5A......................... 1.0
Brassica, leafy greens, subgroup 5B.......................... 10.0
Bushberry subgroup 13-07B.................................... 3.0
Caneberry subgroup 13-07A.................................... 10
Canistel..................................................... 1.2
Canola, seed \1\............................................. 0.03
Citrus, dried pulp........................................... 8.0
Citrus, oil.................................................. 60
Dragon fruit................................................. 2.0
Fruit, pome, group 11-10..................................... 1.7
Fruit, small vine climbing, except fuzzy kiwifruit, subgroup 3.0
13-07F......................................................
Fruit, stone, group 12....................................... 2.0
Grape, raisin................................................ 5.0
Herb subgroup 19A, dried, except parsley..................... 15.0
Herb subgroup 19A, fresh, except parsley..................... 3.0
Kiwifruit.................................................... 1.8
Leaf petioles subgroup 4B.................................... 30
Leafy greens subgroup 4A..................................... 50
Lemon........................................................ 0.60
Lime......................................................... 0.60
Longan....................................................... 2.0
Lychee....................................................... 2.0
Mango........................................................ 1.2
Onion, bulb, subgroup 3-07A.................................. 0.6
Onion, green, subgroup 3-07B................................. 4.0
Papaya....................................................... 1.2
Parsley, dried leaves........................................ 170
Parsley, leaves.............................................. 35
Pistachio.................................................... 0.10
Pulasan...................................................... 2.0
Rambutan..................................................... 2.0
Sapodilla.................................................... 1.2
Sapote, black................................................ 1.2
Sapote, mamey................................................ 1.2
Spanish lime................................................. 2.0
Star apple................................................... 1.2
Turnip, greens............................................... 10.0
Vegetable, cucurbit, group 9................................. 0.70
Vegetable, fruiting, group 8-10.............................. 1.5
Vegetable, leaves of root and tuber, group 2................. 10
Vegetable, root, except sugarbeet, subgroup 1B............... 0.75
Watercress................................................... 20
------------------------------------------------------------------------
\1\ Import only.
* * * * *
[FR Doc. 2012-20235 Filed 8-16-12; 8:45 am]
BILLING CODE 6560-50-P