[Federal Register Volume 83, Number 28 (Friday, February 9, 2018)]
[Rules and Regulations]
[Pages 5711-5717]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-02670]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2016-0649; FRL-9972-61]
Cyflufenamid; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for residues of
cyflufenamid in or on cherry crop subgroup 12-12A, hops dried cones,
and fruiting vegetable crop group 8-10; and amends the tolerance for
cucurbit vegetable crop group 9. Nisso America, on behalf of Nippon
Soda Co., Ltd. requested these tolerances under the Federal Food, Drug,
and Cosmetic Act (FFDCA).
DATES: This regulation is effective February 9, 2018. Objections and
requests for hearings must be received on or before April 10, 2018, 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-2016-0649, is available at http://www.regulations.gov or at the Office of Pesticide Programs
[[Page 5712]]
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: Michael Goodis, 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].
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 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-2016-0649 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
April 10, 2018. 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-2016-0649, 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
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.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 March 23, 2017 (82 FR 14846) (FRL-9957-
99), 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
6F8512) by Nisso America on behalf of Nippon Soda Co., Ltd., 88 Pine
Street, 14th Floor, New York, NY 10005. The petition requested that 40
CFR 180.667 be amended by establishing tolerances for residues of the
fungicide cyflufenamid, in or on cherry crop subgroup 12-12A at 0.6
parts per million (ppm), hops at 5.0 ppm, and fruiting vegetable crop
group 8-10 at 0.2 ppm. Then in the Federal Register of September 15,
2017 (82 FR 43352) (FRL-9965-43), EPA issued another document pursuant
to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing that this
petition also requested the amendment of the existing tolerance for
residues of cyflufenamid in or on cucurbit vegetable group 9,
increasing the tolerance level from 0.07 ppm to 0.10 ppm. Those
documents referenced a summary of the petition prepared by Nisso
America on behalf of Nippon Soda Co., Ltd., the registrant, which is
available in the docket, http://www.regulations.gov. Comments were
received on the notices 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 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 cyflufenamid including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with cyflufenamid 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.
Cyflufenamid has low acute toxicity via the oral, dermal, and
inhalation routes of exposure. Though slightly irritating to the eye,
cyflufenamid is not
[[Page 5713]]
a skin irritant or sensitizer. In the mammalian toxicology database,
the liver was the primary target organ for cyflufenamid toxicity.
Across species, duration and gender, changes in weight, clinical
chemistry, and pathology indicated treatment-related perturbations in
and adverse effects on liver function.
Thyroid effects due to treatment with cyflufenamid, seen only in
the rat, included increased follicular cell hypertrophy (as well as
increased organ weight) and neoplastic thyroid follicular adenomas.
Kidney effects related to treatment included increased kidney weight
accompanied by tubular vacuolation and slight decreases in sodium and
chloride concentrations.
Treatment-related cardiotoxicity was noted in the rat and mouse
feeding studies. Observed myocardial vacuolation and lipidosis may be
attributed to decreased lipid metabolism; cyflufenamid caused an
approximately 50% inhibition of carnitine palmitoyltransferase in both
rat and mouse heart microsomal fractions in a non-guideline mechanistic
study. Carnitine palmitoyltransferase is involved in the transport of
long chain fatty acids into the mitochondrial matrix for oxidation.
Fatty acid oxidation is an important source of energy for adenosine
triphosphate (ATP) production in the mitochondria.
Cyflufenamid-induced brain vacuolation was specific to the dog and
not associated with any apparent clinical sign of neurotoxicity.
Supplementary studies investigating this phenomenon determined that
vacuolation was due to myelin edema affecting the white matter of the
cerebrum and thalamus. Furthermore, this brain lesion was partially
reversed after a 13-week recovery period (following 90-day exposure)
and fully reversed after a 26-week recovery period. This effect was not
observed in any other species. A subchronic neurotoxicity study in rats
showed no evidence of neurotoxicity.
Effects on reproductive organs and/or parameters have been
previously noted in several subchronic studies; however, the effects
occurred at doses above the respective lowest observed adverse effect
level (LOAELs) from the studies used to derive the point of departures
(POD)s. The PODs are protective of these effects. The developmental
studies in rats and rabbits do not indicate any concern for increased
susceptibility to offspring. Although offspring effects of decreased
body weight and incomplete ossification were observed in rabbits, those
effects occurred at doses higher than doses resulting in maternal
effects and are believed to be related to maternal toxicity.
Furthermore, the current PODs are protective of the effects seen on
reproductive parameters in offspring. In addition, mating performance
and fertility in the Parent/Filial (P/F)0 generation were
both unaffected by treatment with cyflufenamid in the 2-generation
reproductive toxicity study in rats. Sex ratio, sexual maturation,
estrous cyclicity, sperm quantity and quality, mating performance and
fertility, gestation and viability indices in the filial 1
(F1) generation were all unaffected by treatment.
When tolerances were last established for cyflufenamid (77 FR
38204, June 27, 2012), EPA had classified cyflufenamid as ``likely to
be carcinogenic to humans'' based on the presence of thyroid follicular
cell tumors in male rats and liver tumors in male mice. Since that
time, EPA has reevaluated the carcinogenic potential of cyflufenamid
and based on available data has reclassified cyflufenamid as having
``suggestive evidence of carcinogenicity.'' A well-established non-
mutagenic mode of action (MOA) for thyroid follicular cell tumors in
male rats was tested and found acceptable. In summary, EPA has
determined that because of the thyroid hormone imbalance, thyroid
follicular cell tumors in male rats are likely to occur. That lead to
an increase in the size (hypertrophy) and number (hyperplasia) of the
thyroid follicular cells and eventually to thyroid neoplasia (or
tumors). Because of marked quantitative differences between rats and
humans in their inherent susceptibility for thyroid tumors in response
to an imbalance in thyroid hormones, EPA concludes that cyflufenamid is
not likely to pose a risk for thyroid follicular cell tumors in humans.
As a result, the database contains the following data concerning
carcinogenicity: (1) There is no evidence of carcinogenicity in female
rats and mice; (2) the MOA data indicates that thyroid follicular cell
tumors may not be relevant to humans; (3) tumors were only found in the
liver in one gender of one species, i.e., male mice; and (4) there is
no concern for mutagenicity or clastogenicity based on the results of
the battery of genotoxicity studies. Therefore, EPA concludes that the
chronic reference dose (cRfD) (0.044 mg/kg/day) will adequately account
for all chronic toxicity, including carcinogenicity (which occurred
only at a dose over 5000x higher than the cRfD) that could result from
exposure to cyflufenamid.
Specific information on the studies received and the nature of the
adverse effects caused by cyflufenamid as well as the no-observed-
adverse-effect-level (NOAEL) and the LOAEL from the toxicity studies
can be found at http://www.regulations.gov in document: ``Cyflufenamid.
Human Health Risk Assessment for Proposed Uses on Fruiting Vegetable
Group 8-10, Cherry crop Subgroup 12-12A, and Hops; and a Revised
Tolerance on Cucurbit Vegetable Group 9'' on page 16 in docket ID
number EPA-HQ-OPP-2016-0649.
B. Toxicological Points of Departure/Levels of Concern
Once a pesticide's toxicological profile is determined, EPA
identifies toxicological 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 based on a careful analysis of
each toxicological study to determine the values of the NOAEL and 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://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
A summary of the toxicological endpoints for cyflufenamid used for
human risk assessment is shown in the Table of this unit.
Table Summary of Points of Departure and Toxicity Endpoints Used in
Human Risk Assessment
[[Page 5714]]
Table--Summary of Toxicological Doses and Endpoints for Cyflufenamid for Use in Dietary,
Non-Occupational and Occupational Human Health Risk Assessments
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Uncertainty/ RfD, PAD, level
Exposure/ scenario Point of FQPA safety of concern for Study and toxicological
departure factors risk dssessment effects
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Acute Dietary (All There were no appropriate toxicological effects attributable to a single exposure
Populations). (dose) observed in appropriate toxicity studies. Therefore, a dose and endpoint
were not identified for this risk assessment.
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Chronic Dietary (All NOAEL = 4.4 mg/ UFA = 10x Chronic RfD = Combined Chronic Toxicity/
Populations). kg/day UFH = 10x...... 0.044 mg/kg/ Carcinogenicity Study in
FQPA SF = 1x... day Rats.
cPAD = 0.044 mg/ LOAEL = 22 mg/kg/day based on
kg/day. increased thyroid/parathyroid
weight, increased liver
weight and centrilobular
hepatocytic hypertrophy.
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Dermal Short-Term (1-30 days) No adverse effects were observed in the dermal toxicity study and there are no
and Intermediate-Term (1-6 concerns for developmental or neurological toxicities; therefore, no hazards are
months). expected from these exposure scenarios.
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Inhalation Short-Term (1-30 NOAEL = 5 mg/kg/ UFA = 10x Residential/ Prenatal Developmental Study
days) and Intermediate-Term day UFH = 10x...... Occupational in Rabbits.
(1-6 months). FQPA SF = 1x... LOC for MOE = Maternal LOAEL = 10 mg/kg/day
100 based on decreased body
weight, body weight gains and
food consumption.
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Cancer (oral, dermal, Classification: ``Suggestive evidence of carcinogenic potential'' and
inhalation). quantification of risk using a non-linear approach (i.e., RfD approach) is
appropriate.
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Point of Departure (POD) = A data point or an estimated point that is derived from observed dose-response data
and used to mark the beginning of extrapolation to determine risk associated with lower environmentally
relevant human exposures. NOAEL = no observed adverse effect level. LOAEL = lowest observed adverse effect
level. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential
variation in sensitivity among members of the human population (intraspecies). FQPA SF = FQPA Safety Factor.
PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. MOE = margin of exposure. LOC =
level of concern.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to cyflufenamid, EPA considered exposure under the petitioned-
for tolerances as well as all existing cyflufenamid tolerances in 40
CFR 180.667. EPA assessed dietary exposures from cyflufenamid 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.
No such effects were identified in the toxicological studies for
cyflufenamid; therefore, a quantitative acute dietary exposure
assessment is unnecessary.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the U.S. Department
of Agriculture's National Health and Nutrition Examination Survey, What
We Eat in America (USDA's NHANES/WWEIA). As to residue levels in food,
EPA assumed tolerance-level residues and 100% crop treated (100% CT)
for all commodities.
iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that a nonlinear RfD approach is appropriate for assessing
cancer risk to cyflufenamid. Cancer risk was assessed using the same
exposure estimates as discussed in Unit III.C.1.ii., chronic exposure.
iv. Anticipated residue and percent crop treated (PCT) information.
EPA did not use anticipated residue and PCT information in the dietary
assessment for cyflufenamid. Tolerance-level residues and 100% CT were
assumed for all food commodities.
2. Dietary exposure from drinking water. The Agency used screening-
level water exposure models in the dietary exposure analysis and risk
assessment for cyflufenamid in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of cyflufenamid. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
The Agency used Tier II surface water and Tier I ground water
simulations for all proposed cyflufenamid uses and label modifications.
The estimated drinking water concentrations (EDWCs) of cyflufenamid for
chronic exposures are 1.15 parts per billion (ppb) for surface water
and 29.6 ppb for ground water.
Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For acute dietary risk
assessment, no toxic effects attributable to a single exposure to
cyflufenamid have been identified; therefore, an acute reference dose
(aRfD) has not been established and an acute dietary exposure
assessment was not conducted. For chronic and cancer dietary risk
assessments, the ground water concentration value of 29.6 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).
Although the Agency previously assessed residential handler
exposure and risk estimates from the use of cyflufenamid on ornamental
use sites, the Agency now assumes that cyflufenamid is only used by
commercial applicators based on labeling requiring handlers to use
personal protective equipment (PPE). Therefore, the Agency concludes
that there are no residential handler exposures to assess.
The Agency has also determined that there are no post-application
residential exposures to assess. Although there is a potential for
residential dermal post-application exposure from the existing uses of
cyflufenamid, there is no adverse systemic hazard via the dermal route
of exposure. Moreover, there is no
[[Page 5715]]
incidental oral exposure expected from cyflufenamid use on ornamental
plants.
Therefore, the Agency has concluded that there are no residential
exposure scenarios to aggregate with dietary exposures for
cyflufenamid.
Further information regarding EPA standard assumptions and generic
inputs for residential exposures may be found at http://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 cyflufenamid to share a common mechanism of
toxicity with any other substances, and cyflufenamid does not appear to
produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
cyflufenamid 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 website at http://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. There is no evidence of
susceptibility following in utero and/or postnatal exposure in the
developmental toxicity studies in rats or rabbits, and in the 2-
generation rat reproduction study. Neither the rat nor rabbit
developmental studies identified teratogenic effects. The marginally
higher incidence of incompletely ossified epiphyses and metacarpals/
phalanges seen in rabbits may be associated with low fetal weight and
are indicative of delayed embryo-fetal development. The combined
offspring effects of decreased body weight and incomplete ossification
are believed to be related to the observed maternal toxicity.
Furthermore, the PODs selected for all exposure scenarios are lower
than those doses causing adverse effects in offspring.
There are no residual uncertainties concerning pre- and postnatal
toxicity and no neurotoxicity concerns.
3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1X. That decision is based on the following
findings:
i. The toxicity database for cyflufenamid is complete.
ii. There is no indication that cyflufenamid is a neurotoxic
chemical and there is no need for a developmental neurotoxicity study
or additional UFs to account for neurotoxicity.
iii. There is no evidence that cyflufenamid 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 dietary food exposure assessments were performed based
on 100% CT and tolerance-level residues. EPA made conservative
(protective) assumptions in the ground and surface water modeling used
to assess exposure to cyflufenamid in drinking water. These assessments
will not underestimate the exposure and risks posed by cyflufenamid.
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 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. An acute aggregate risk assessment takes into
account acute exposure estimates from dietary consumption of food and
drinking water. No adverse effect resulting from a single oral exposure
was identified and no acute dietary endpoint was selected. Therefore,
cyflufenamid is not expected to pose an acute risk.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
cyflufenamid from food and water will utilize 2.8% of the cPAD for the
general U.S. population and 6.1% for children 1-2 years old, the
population group receiving the greatest exposure. Based on the
explanation in Unit III.C.3., regarding the lack of residential use
patterns, chronic residential exposure to residues of cyflufenamid is
not expected.
3. Short-term risk. A short-term adverse effect was identified for
inhalation and oral exposures; however, cyflufenamid is not registered
for any use patterns that would result in short-term residential
exposure. Short-term risk is assessed based on short-term residential
exposure plus chronic dietary exposure. Because there is no short-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 short-term risk), no further
assessment of short-term risk is necessary, and EPA relies on the
chronic dietary risk assessment for evaluating short-term risk for
cyflufenamid.
4. Intermediate-term risk. An intermediate-term adverse effect was
identified; however, cyflufenamid 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 cyflufenamid.
5. Aggregate cancer risk for U.S. population. EPA has determined
that quantification of risk using the RfD approach is appropriate and
will adequately account for all chronic toxicity, including
carcinogenicity, that could result from exposure to
[[Page 5716]]
cyflufenamid. Based on the conclusions of the chronic dietary
assessment, EPA concludes that exposure to cyflufenamid is unlikely to
pose an aggregate cancer risk.
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 cyflufenamid residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (High-Performance Liquid
Chromatography Method with tandem mass spectrometry detection (LC/MS/
MS), Method No. RD-01307) is available to enforce the tolerance
expression. 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 not
established a MRL for cyflufenamid.
C. Response to Comments
Several comments were received on the publication. While some
comments raised issues outside the scope of the FFDCA analysis, the
remaining comments primarily expressed general concerns about the
potential health effects of pesticides residues in or on food and one
comment asked that the combined effects of multiple pesticides be
considered on food commodities. None of the comments specifically
mentioned any particular safety concerns with cyflufenamid nor did any
commenters provide supporting information for the Agency to evaluate or
on which the Agency could rely to support a finding on the petitioned-
for tolerances.
EPA recognizes that some individuals believe that pesticides should
be banned on agricultural crops. The existing legal framework provided
by section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA),
however, 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. EPA has assessed the effects
of cyflufenamid on human health and determined that aggregate exposure
to it will be safe. These comments provide no information to support an
alternative conclusion.
As noted in Unit III.C.4., Congress has directed EPA to consider
the cumulative risk of pesticide residues with residues of ``other
substances that have a common mechanism of toxicity.'' FFDCA section
408(b)(2)(D)(v). At this time, EPA has not concluded that cyflufenamid
has a common mechanism of toxicity with any other pesticides. The
petitioner has not provided any other information to support a
different conclusion.
D. Revisions to Petitioned-for Tolerances
EPA is establishing tolerances that vary slightly from requests in
the petition by adding another significant figure to the tolerance
levels for subgroup 12-12A and group 8-10 and revising commodity term
for hops to match the Agency's commodity vocabulary.
V. Conclusion
Therefore, tolerances are established for residues of cyflufenamid,
in or on cherry crop subgroup 12-12A at 0.60 ppm; hop, dried cones at
5.0 ppm; and fruiting vegetable group 8-10 at 0.20 ppm; and the
tolerance for residues in or on cucurbit vegetable group 9 is increased
to 0.10 ppm.
VI. Statutory and Executive Order Reviews
This action establishes and amends 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)), or Executive Order 13771,
entitled ``Reducing Regulations and Controlling Regulatory Costs'' (82
FR 9339, February 3, 2017). 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).
[[Page 5717]]
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: January 24, 2018.
Michael Goodis,
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. 180.667, amend the table in paragraph (a) by:
0
i. Adding alphabetically the commodities ``Cherry subgroup 12-12A'',
``Hop, dried cones'', and ``Vegetable, fruiting, group 8-10'', and
0
ii. Revising the commodity ``Vegetable, cucurbit, group 9''.
The additions and revisions read as follows:
Sec. [emsp14]180.667 Cyflufenamid; tolerances for residues.
(a) * * *
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Cherry subgroup 12-12A....................................... 0.60
* * * * *
Hop, dried cones............................................. 5.0
Vegetable, cucurbit, group 9................................. 0.10
Vegetable, fruiting, group 8-10.............................. 0.20
------------------------------------------------------------------------
* * * * *
[FR Doc. 2018-02670 Filed 2-8-18; 8:45 am]
BILLING CODE 6560-50-P