[Federal Register Volume 80, Number 174 (Wednesday, September 9, 2015)]
[Rules and Regulations]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-22031]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
Cyprodinil; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
SUMMARY: This regulation establishes tolerances for residues of
cyprodinil in or on multiple commodities that are identified and
discussed later in this document, and removes the established tolerance
on fruit, stone, group 12. Interregional Research Project Number 4
(IR-4) requested these tolerances under the Federal Food, Drug, and
Cosmetic Act (FFDCA).
DATES: This regulation is effective September 9, 2015. Objections and
requests for hearings must be received on or before November 9, 2015,
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-2014-0506, is available at http://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 http://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: [email protected].
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 http://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-2014-0506 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
November 9, 2015. 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-2014-0506, 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 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
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.html. 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 September 5, 2014 (79 FR 53009) (FRL-
9914-98), 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
4E8293) by IR-4, 500 College Road East, Suite 201W, Princeton, NJ
08540. The petition requested that 40 CFR part 180 be amended by
establishing tolerances for residues of the fungicide cyprodinil, 4-
cyclopropyl-6-methyl-N-phenyl-2-pyrimidinamine, in or on acerola at 1.5
parts per million (ppm); artichoke, globe at 4.0 ppm; feijoa at 1.5
ppm; fruit, stone group 12-12 at 2.0 ppm; guava at 1.5 ppm; jaboticaba
at 1.5 ppm; passionfruit at 1.5 ppm; pomegranate at 7.0 ppm; starfruit
at 1.5 ppm; and wax jambu at 1.5 ppm. This petition additionally
requested to remove the tolerance in 40 CFR 180.532 for residues of
cyprodinil in or on fruit, stone, group 12 at 2.0 ppm. That document
referenced a summary of the petition prepared on behalf of IR-4 by
Syngenta Crop Protection, the registrant, which is available in the
docket, http://www.regulations.gov. Comments were received on the
notice of filing. EPA's response to these comments is discussed in Unit
Based upon review of the data supporting the petition, EPA has
revised the proposed tolerance on pomegranate, and has revised the
commodity definition for artichoke to artichoke, globe. 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
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
The major target organs of cyprodinil are the liver and the kidney.
Liver effects were consistent among rats and mice in both subchronic
and chronic studies and typically included increased liver weights and
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,
chronic tubular lesions and chronic kidney inflammation following
subchronic exposure and increased kidney weights and progressive
nephropathy following chronic exposures in male rats. Chronic effects
in dogs were limited to decreased body-weight gain, decreased food
consumption and decreased food efficiency. The hematopoietic system
also appeared to be a target of cyprodinil, as mild anemia was seen
following subchronic rat exposure (reductions in hematocrit and
hemoglobin and microcytosis). Although increases in thyroid weight or
hypertrophy of thyroid follicular cells were observed at higher doses
in the 28-day and 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 liver weights
at the highest dose tested. There were no treatment-related effects on
spleen or thymus weights; no effects on specific activity or total
activity of splenic immunoglobulin M (IgM) antibody-forming cells to
the T cell-dependent antigen sheep red blood cells (sRBC).
An acute neurotoxicity study indicated systemic toxicity with signs
of induced hunched posture, pilorection, and reduced responsiveness to
sensory stimuli and reduced motor activity. Clinical signs,
hypothermia, and changes in motor activity were found to be reversible
by day 8 and 15 investigations. A subchronic neurotoxicity study showed
no treatment related effects on mortality, clinical signs, or gross or
histological neuropathology. Functional observational battery (FOB) 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 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. Each of these fetal or
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.
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. Human Health Risk
Assessment for the Expansion of Existing Crop Group/Representative
Commodity Uses to Stone Fruit Group 12-12, and Adding New Uses on the
Artichoke, Guava, Pomegranate, Passionfruit, Feijoa, Jaboticaba, Wax
Jambu, Starfruit, and Acerola and Amended Uses on Greenhouse Cucumbers
and Small Tomatoes at pages 36-40 in docket ID number EPA-HQ-OPP-2014-
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 no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
A summary of the toxicological endpoints for cyprodinil used for
human risk assessment is discussed in Unit III.B. of the final rule
published in the Federal Register of October 16, 2012 (77 FR 49732)
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to cyprodinil, EPA considered exposure under the petitioned-
for tolerances as well as all existing cyprodinil tolerances in 40 CFR
180.532. EPA assessed dietary exposures from cyprodinil in food as
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) National Health and Nutrition Examination Survey,
What We Eat in America, (NHANES/WWEIA), from 2003 to 2008. As to
residue levels in food, EPA utilized tolerance-level residues and 100
percent crop treated (PCT) for all commodities. The acute assessment
also incorporated Dietary Exposure Evaluation Model software with the
Food Commodity Intake Database (DEEM-FCID) Version 3.18 default
processing factors; and empirical processing factors for tomato paste/
tomato puree and lemon/lime juice, where 1X empirical processing
factors were used to modify the tolerance values.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA NHANES/
WWEIA. As to residue levels in food, EPA utilized average field trial
residues for pome fruit, head lettuce, leaf lettuce, spinach, tomato,
and grape and tolerance-level residues for the remaining commodities.
The Agency also assumed 100 PCT. The chronic assessment also
incorporated DEEM default processing factors except for tomato paste/
tomato puree and lemon juice/lime juice, where a 1X empirical
processing factor was 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 and PCT information. Section 408(b)(2)(E)
of FFDCA authorizes EPA to use available data and information on the
anticipated residue levels of pesticide residues in food and the actual
levels of pesticide residues that have been measured in food. If EPA
relies on such information, EPA must require pursuant to FFDCA section
408(f)(1) that data be provided 5 years after the tolerance is
established, modified, or left in effect, demonstrating that the levels
in food are not above the levels anticipated. For the present action,
EPA will issue such data call-ins as are required by FFDCA section
408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Data will be
required to be submitted no later than 5 years from the date of
issuance of these tolerances.
2. Dietary exposure from drinking water. The residues of concern in
drinking water for risk assessment purposes are cyprodinil and the
degradate CGA 249287. The estimated drinking water concentrations
(EDWCs) for each of these was calculated using a molecular weight
conversion and then combined for each modeled scenario. 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 http://www.epa.gov/oppefed1/models/water/index.htm.
Based on the Pesticide Root Zone Model/Exposure Analysis Modeling
System (PRZM/EXAMS), Screening Concentration in Ground Water (SCI-
GROW), and Pesticide Root Zone Model for Groundwater (PRZM-GW) models,
the 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. The water concentration values
of 34.8 ppb and 24.7 ppb were used to assess the contribution to
drinking water for the acute and chronic dietary risk assessments,
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 adult residential handlers from the
application of cyprodinil to ornamental landscapes. The residential
handler exposure scenarios were considered to be short-term only, due
to the infrequent use patterns associated with homeowner products.
Dermal exposures were not assessed since there was no dermal endpoint
identified for cyprodinil. Postapplication exposures to adults or
children were not expected and were not assessed. Further information
regarding EPA standard assumptions and generic inputs for residential
exposures may be found at http://www.epa.gov/pesticides/science/residential-exposure-sop.html.
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
EPA has not found cyprodinil to share a common mechanism of
toxicity with any other substances, and cyprodinil does not appear to
produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
cyprodinil does not have a common mechanism of toxicity with other
substances. For information regarding EPA's efforts to determine which
chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see EPA's Web site at 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 Safety
Factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
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 or 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
i. The toxicity database for cyprodinil is complete, except for a
90-day inhalation toxicity study. In the absence of a route-specific
inhalation study, EPA is relying on the 28-day feeding/range-
finding rat oral study to estimate risk from inhalation exposures. EPA
has determined that the use of this study to extrapolate an inhalation
endpoint may understate risk. Accordingly, to address this uncertainty,
EPA has concluded that the 10X FQPA SF should be retained for risk
assessments involving inhalation exposure.
ii. As to evidence of neurotoxicity, 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 three to four. For the subchronic neurotoxicity study in
rats, there was no indication that cyprodinil is a neurotoxic chemical.
Based on this evidence, there is no need for a developmental
neurotoxicity study or additional UFs to account for neurotoxicity.
iii. When toxicity was observed in the prenatal developmental
toxicity studies in rats and rabbits and the two-generation
reproduction study in rats, toxicity to the fetuses or offspring
occurred at the same doses at which effects were observed in maternal/
parental animals. Additionally, the skeletal anomalies or 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 two-generation
iv. There are no residual uncertainties identified in the exposure
databases. The acute dietary assessment was conservative and based upon
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, 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
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, 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 concluded the combined short-term food, water,
and residential exposures result in an aggregate MOE of 7,900. 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
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
The methods may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD
20755-5350; telephone number: (410) 305-2905; email address:
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 stone fruit
at 2.0 ppm. This MRL is the same as the tolerance established for
cyprodinil in the United States for fruit, stone, group 12-12. The
Codex has not established a MRL for cyprodinil in or on the other
commodities associated with this action.
C. Response to Comments
Several comments were received in response to the notice of filing.
All but one were concerned with potential environmental impacts, and
were not specifically related to the cyprodinil action. EPA notes that
these comments address potential environmental concerns; however, the
safety standard for approving tolerances under section 408 of the FFDCA
focuses on potential harms to human health and does not permit
consideration of effects on the environment.
One additional comment was received that did not specifically
address the cyprodinil action, but that raised concerns about the
toxicity of pesticides and requested that no tolerance be established.
The Agency understands the commenter's concerns and recognizes that
some individuals believe that pesticides should be banned on
agricultural crops. However, the existing legal framework provided by
section 408 of the FFDCA states that tolerances may be set when persons
seeking such tolerances or exemptions have demonstrated that the
pesticide meets the safety standard imposed by that statute. This
citizen's comment appears to be directed at the underlying statute and
not EPA's implementation of it; the citizen has made no contention that
EPA has acted in violation of the statutory framework. EPA has found
that there is a reasonable certainty of no harm to humans after
considering the toxicological studies and the exposure levels of humans
D. Revisions to Petitioned-For Tolerances
Based on the data submitted with the petition, EPA has determined
that the proposed tolerance in or on pomegranate at 7.0 ppm should be
established at 10 ppm. This tolerance level was determined by the
Organization for Economic Cooperation and Development tolerance
calculation procedures. Additionally, the Agency is establishing a
tolerance in or on artichoke, globe, rather than the petitioned-for
commodity artichoke in order to provide the correct commodity
Therefore, tolerances are established for residues of cyprodinil,
4-cyclopropyl-6-methyl-N-phenyl-2-pyrimidinamine, in or on acerola at
1.5 ppm; artichoke, globe at 4.0 ppm; feijoa at 1.5 ppm; fruit, stone,
group 12-12 at 2.0 ppm; guava at 1.5 ppm; jaboticaba at 1.5 ppm;
passionfruit at 1.5 ppm; pomegranate at 10 ppm; starfruit at 1.5 ppm;
and wax jambu at 1.5 ppm. Additionally, this action removes the
tolerance established in or on fruit, stone, group 12 at 2.0 ppm as
that crop group tolerance is superseded by the tolerance being
established in this action for crop group 12-12.
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 tolerances 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
Dated: August 13, 2015.
Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
2. In Sec. 180.532, remove the entry, ``Fruit, stone, group 12'' and
alphabetically add the following commodities to the table in paragraph
(a) to read as follows:
Sec. 180.532 Cyprodinil; tolerances for residues.
(a) * * *
* * * * *
Artichoke, globe............................................ 4.0
* * * * *
* * * * *
Fruit, stone, group 12-12................................... 2.0
* * * * *
* * * * *
* * * * *
* * * * *
* * * * *
* * * * *
Wax jambu................................................... 1.5
* * * * *
[FR Doc. 2015-22031 Filed 9-8-15; 8:45 am]
BILLING CODE 6560-50-P