83_FR_5739 83 FR 5711 - Cyflufenamid; Pesticide Tolerances

83 FR 5711 - Cyflufenamid; Pesticide Tolerances

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 83, Issue 28 (February 9, 2018)

Page Range5711-5717
FR Document2018-02670

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).

Federal Register, Volume 83 Issue 28 (Friday, February 9, 2018)
[Federal Register Volume 83, Number 28 (Friday, February 9, 2018)]
[Rules and Regulations]
[Pages 5711-5717]
From the Federal Register Online  [www.thefederalregister.org]
[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: RDFRNotices@epa.gov.

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's 
tolerance regulations at 40 CFR part 180 through the Government 
Printing Office's e-CFR site at 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
----------------------------------------------------------------------------------------------------------------
                                                  Uncertainty/   RfD, PAD, level
      Exposure/ scenario           Point of       FQPA safety     of concern for      Study and toxicological
                                  departure         factors      risk dssessment              effects
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------
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: 
residuemethods@epa.gov.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint United Nations 
Food and Agriculture Organization/World Health Organization food 
standards program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level. The Codex has not 
established 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



                                                                 Federal Register / Vol. 83, No. 28 / Friday, February 9, 2018 / Rules and Regulations                                                5711

                                              also available for inspection at the                    and effective September 15, 2017. FAA                 PART 71—DESIGNATION OF CLASS A,
                                              National Archives and Records                           Order 7400.11B is publicly available as               B, C, D, AND E AIRSPACE AREAS; AIR
                                              Administration (NARA). For                              listed in the ADDRESSES section of this               TRAFFIC SERVICE ROUTES; AND
                                              information on the availability of FAA                  document. FAA Order 7400.11B lists                    REPORTING POINTS
                                              Order 7400.11B at NARA, call (202)                      Class A, B, C, D, and E airspace areas,
                                              741–6030, or go to https://                             air traffic service routes, and reporting             ■ 1. The authority citation for part 71
                                              www.archives.gov/federal-register/cfr/                  points.                                               continues to read as follows:
                                              ibr-locations.html.                                                                                             Authority: 49 U.S.C. 106(f), 106(g); 40103,
                                                 FAA Order 7400.11, Airspace                          The Rule
                                                                                                                                                            40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR,
                                              Designations and Reporting Points, is                     This amendment to title 14, Code of                 1959–1963 Comp., p. 389.
                                              published yearly and effective on                       Federal Regulations (14 CFR) part 71
                                              September 15.                                           removes the Class E airspace area                     § 71.1       [Amended]
                                              FOR FURTHER INFORMATION CONTACT:                        extending upward from 700 feet above                  ■ 2. The incorporation by reference in
                                              Jeffrey Claypool, Federal Aviation                      the surface within a 6.9-mile radius of               14 CFR 71.1 of FAA Order 7400.11B,
                                              Administration, Operations Support                      Carter Airport, Pulaski, WI.                          Airspace Designations and Reporting
                                              Group, Central Service Center, 10101                      This action is necessary due to the                 Points, dated August 3, 2017, and
                                              Hillwood Parkway, Fort Worth, TX,                       cancellation of the instrument                        effective September 15, 2017, is
                                              76177; telephone (817) 222–5711.                        procedures at Carter Airport. The                     amended as follows:
                                              SUPPLEMENTARY INFORMATION:                              removal of these procedures results in
                                                                                                                                                            Paragraph 6005 Class E Airspace Areas
                                                                                                      the airport no longer qualifying for                  Extending Upward From 700 Feet or More
                                              Authority for This Rulemaking                           controlled airspace.                                  Above the Surface of the Earth.
                                                 The FAA’s authority to issue rules
                                                                                                      Regulatory Notices and Analyses                       *        *      *     *     *
                                              regarding aviation safety is found in
                                              Title 49 of the United States Code.                        The FAA has determined that this                   AGL WI E5         Pulaski, WI [Removed]
                                              Subtitle I, Section 106 describes the                   regulation only involves an established
                                                                                                      body of technical regulations for which                 Issued in Fort Worth, Texas, on January 29,
                                              authority of the FAA Administrator.                                                                           2018.
                                              Subtitle VII, Aviation Programs,                        frequent and routine amendments are
                                                                                                      necessary to keep them operationally                  Christopher L. Southerland,
                                              describes in more detail the scope of the
                                              agency’s authority. This rulemaking is                  current, is non-controversial and                     Acting Manager, Operations Support Group,
                                                                                                      unlikely to result in adverse or negative             ATO Central Service Center.
                                              promulgated under the authority
                                                                                                      comments. It, therefore: (1) Is not a                 [FR Doc. 2018–02137 Filed 2–8–18; 8:45 am]
                                              described in Subtitle VII, Part A,
                                              Subpart I, Section 40103. Under that                    ‘‘significant regulatory action’’ under               BILLING CODE 4910–13–P

                                              section, the FAA is charged with                        Executive Order 12866; (2) is not a
                                              prescribing regulations to assign the use               ‘‘significant rule’’ under DOT
                                              of airspace necessary to ensure the                     Regulatory Policies and Procedures (44                ENVIRONMENTAL PROTECTION
                                              safety of aircraft and the efficient use of             FR 11034; February 26, 1979); and (3)                 AGENCY
                                              airspace. This regulation is within the                 does not warrant preparation of a
                                              scope of that authority as it supports the              regulatory evaluation as the anticipated              40 CFR Part 180
                                              removal of Class E airspace extending                   impact is so minimal. Since this is a                 [EPA–HQ–OPP–2016–0649; FRL–9972–61]
                                              upward from 700 feet above the surface                  routine matter that only affects air traffic
                                              at Carter Airport, Pulaski, WI.                         procedures and air navigation, it is                  Cyflufenamid; Pesticide Tolerances
                                                                                                      certified that this rule, when
                                              History                                                                                                       AGENCY:  Environmental Protection
                                                                                                      promulgated, does not have a significant
                                                 The FAA published a notice of                                                                              Agency (EPA).
                                                                                                      economic impact on a substantial
                                              proposed rulemaking in the Federal                                                                            ACTION: Final rule.
                                                                                                      number of small entities under the
                                              Register (82 FR 45749; October 2, 2017)                 criteria of the Regulatory Flexibility Act.           SUMMARY:   This regulation establishes
                                              for Docket No. FAA–2017–0818 to                                                                               tolerances for residues of cyflufenamid
                                              remove Class E airspace extending                       Environmental Review
                                                                                                                                                            in or on cherry crop subgroup 12–12A,
                                              upward from 700 feet above the surface                     The FAA has determined that this                   hops dried cones, and fruiting vegetable
                                              at Carter Airport, Pulaski, WI. Interested              action qualifies for categorical exclusion            crop group 8–10; and amends the
                                              parties were invited to participate in                  under the National Environmental                      tolerance for cucurbit vegetable crop
                                              this rulemaking effort by submitting                    Policy Act in accordance with FAA                     group 9. Nisso America, on behalf of
                                              written comments on the proposal to the                 Order 1050.1F, ‘‘Environmental                        Nippon Soda Co., Ltd. requested these
                                              FAA. No comments were received.                         Impacts: Policies and Procedures,’’                   tolerances under the Federal Food,
                                                 Class E airspace designations are                    paragraph 5–6.5.a. This airspace action               Drug, and Cosmetic Act (FFDCA).
                                              published in paragraph 6005 of FAA                      is not expected to cause any potentially
                                              Order 7400.11B, dated August 3, 2017,                                                                         DATES: This regulation is effective
                                                                                                      significant environmental impacts, and
                                              and effective September 15, 2017, which                 no extraordinary circumstances exist                  February 9, 2018. Objections and
                                              is incorporated by reference in 14 CFR                  that warrant preparation of an                        requests for hearings must be received
                                              71.1. The Class E airspace designations                 environmental assessment.                             on or before April 10, 2018, and must
                                              listed in this document will be                                                                               be filed in accordance with the
                                              published subsequently in the Order.                    Lists of Subjects in 14 CFR Part 71                   instructions provided in 40 CFR part
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                                                                                                        Airspace, Incorporation by reference,               178 (see also Unit I.C. of the
                                              Availability and Summary of                                                                                   SUPPLEMENTARY INFORMATION).
                                                                                                      Navigation (air).
                                              Documents for Incorporation by                                                                                ADDRESSES: The docket for this action,
                                              Reference                                               Adoption of the Amendment                             identified by docket identification (ID)
                                                This document amends FAA Order                          In consideration of the foregoing, the              number EPA–HQ–OPP–2016–0649, is
                                              7400.11B, Airspace Designations and                     Federal Aviation Administration                       available at http://www.regulations.gov
                                              Reporting Points, dated August 3, 2017,                 amends 14 CFR part 71 as follows:                     or at the Office of Pesticide Programs


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                                              5712               Federal Register / Vol. 83, No. 28 / Friday, February 9, 2018 / Rules and Regulations

                                              Regulatory Public Docket (OPP Docket)                   OPP–2016–0649 in the subject line on                  tolerance for residues of cyflufenamid in
                                              in the Environmental Protection Agency                  the first page of your submission. All                or on cucurbit vegetable group 9,
                                              Docket Center (EPA/DC), West William                    objections and requests for a hearing                 increasing the tolerance level from 0.07
                                              Jefferson Clinton Bldg., Rm. 3334, 1301                 must be in writing, and must be                       ppm to 0.10 ppm. Those documents
                                              Constitution Ave. NW, Washington, DC                    received by the Hearing Clerk on or                   referenced a summary of the petition
                                              20460–0001. The Public Reading Room                     before April 10, 2018. Addresses for                  prepared by Nisso America on behalf of
                                              is open from 8:30 a.m. to 4:30 p.m.,                    mail and hand delivery of objections                  Nippon Soda Co., Ltd., the registrant,
                                              Monday through Friday, excluding legal                  and hearing requests are provided in 40               which is available in the docket, http://
                                              holidays. The telephone number for the                  CFR 178.25(b).                                        www.regulations.gov. Comments were
                                              Public Reading Room is (202) 566–1744,                    In addition to filing an objection or               received on the notices of filing. EPA’s
                                              and the telephone number for the OPP                    hearing request with the Hearing Clerk                response to these comments is
                                              Docket is (703) 305–5805. Please review                 as described in 40 CFR part 178, please               discussed in Unit IV.C.
                                              the visitor instructions and additional                 submit a copy of the filing (excluding
                                                                                                      any Confidential Business Information                 III. Aggregate Risk Assessment and
                                              information about the docket available                                                                        Determination of Safety
                                              at http://www.epa.gov/dockets.                          (CBI)) for inclusion in the public docket.
                                                                                                      Information not marked confidential                      Section 408(b)(2)(A)(i) of FFDCA
                                              FOR FURTHER INFORMATION CONTACT:
                                                                                                      pursuant to 40 CFR part 2 may be                      allows EPA to establish a tolerance (the
                                              Michael Goodis, Registration Division
                                                                                                      disclosed publicly by EPA without prior               legal limit for a pesticide chemical
                                              (7505P), Office of Pesticide Programs,
                                                                                                      notice. Submit the non-CBI copy of your               residue in or on a food) only if EPA
                                              Environmental Protection Agency, 1200
                                                                                                      objection or hearing request, identified              determines that the tolerance is ‘‘safe.’’
                                              Pennsylvania Ave. NW, Washington, DC
                                                                                                      by docket ID number EPA–HQ–OPP–                       Section 408(b)(2)(A)(ii) of FFDCA
                                              20460–0001; main telephone number:
                                                                                                      2016–0649, by one of the following                    defines ‘‘safe’’ to mean that ‘‘there is a
                                              (703) 305–7090; email address:
                                                                                                      methods:                                              reasonable certainty that no harm will
                                              RDFRNotices@epa.gov.
                                                                                                        • Federal eRulemaking Portal: http://               result from aggregate exposure to the
                                              SUPPLEMENTARY INFORMATION:                              www.regulations.gov. Follow the online                pesticide chemical residue, including
                                              I. General Information                                  instructions for submitting comments.                 all anticipated dietary exposures and all
                                                                                                      Do not submit electronically any                      other exposures for which there is
                                              A. Does this action apply to me?                        information you consider to be CBI or                 reliable information.’’ This includes
                                                 You may be potentially affected by                   other information whose disclosure is                 exposure through drinking water and in
                                              this action if you are an agricultural                  restricted by statute.                                residential settings, but does not include
                                              producer, food manufacturer, or                           • Mail: OPP Docket, Environmental                   occupational exposure. Section
                                              pesticide manufacturer. The following                   Protection Agency Docket Center (EPA/                 408(b)(2)(C) of FFDCA requires EPA to
                                              list of North American Industrial                       DC), (28221T), 1200 Pennsylvania Ave.                 give special consideration to exposure
                                              Classification System (NAICS) codes is                  NW, Washington, DC 20460–0001.                        of infants and children to the pesticide
                                              not intended to be exhaustive, but rather                 • Hand Delivery: To make special                    chemical residue in establishing a
                                              provides a guide to help readers                        arrangements for hand delivery or                     tolerance and to ‘‘ensure that there is a
                                              determine whether this document                         delivery of boxed information, please                 reasonable certainty that no harm will
                                              applies to them. Potentially affected                   follow the instructions at http://                    result to infants and children from
                                              entities may include:                                   www.epa.gov/dockets/contacts.html.                    aggregate exposure to the pesticide
                                                 • Crop production (NAICS code 111).                  Additional instructions on commenting                 chemical residue. . . .’’
                                                 • Animal production (NAICS code                      or visiting the docket, along with more                  Consistent with FFDCA section
                                              112).                                                   information about dockets generally, is               408(b)(2)(D), and the factors specified in
                                                 • Food manufacturing (NAICS code                     available at http://www.epa.gov/                      FFDCA section 408(b)(2)(D), EPA has
                                              311).                                                   dockets.                                              reviewed the available scientific data
                                                 • Pesticide manufacturing (NAICS                     II. Summary of Petitioned-For                         and other relevant information in
                                              code 32532).                                            Tolerance                                             support of this action. EPA has
                                                                                                                                                            sufficient data to assess the hazards of
                                              B. How can I get electronic access to                      In the Federal Register of March 23,               and to make a determination on
                                              other related information?                              2017 (82 FR 14846) (FRL–9957–99),                     aggregate exposure for cyflufenamid
                                                 You may access a frequently updated                  EPA issued a document pursuant to                     including exposure resulting from the
                                              electronic version of EPA’s tolerance                   FFDCA section 408(d)(3), 21 U.S.C.                    tolerances established by this action.
                                              regulations at 40 CFR part 180 through                  346a(d)(3), announcing the filing of a                EPA’s assessment of exposures and risks
                                              the Government Printing Office’s e-CFR                  pesticide petition (PP 6F8512) by Nisso               associated with cyflufenamid follows.
                                              site at http://www.ecfr.gov/cgi-bin/text-               America on behalf of Nippon Soda Co.,
                                              idx?&c=ecfr&tpl=/ecfrbrowse/Title40/                    Ltd., 88 Pine Street, 14th Floor, New                 A. Toxicological Profile
                                              40tab_02.tpl                                            York, NY 10005. The petition requested                   EPA has evaluated the available
                                                                                                      that 40 CFR 180.667 be amended by                     toxicity data and considered its validity,
                                              C. How can I file an objection or hearing               establishing tolerances for residues of               completeness, and reliability as well as
                                              request?                                                the fungicide cyflufenamid, in or on                  the relationship of the results of the
                                                Under FFDCA section 408(g), 21                        cherry crop subgroup 12–12A at 0.6                    studies to human risk. EPA has also
                                              U.S.C. 346a, any person may file an                     parts per million (ppm), hops at 5.0                  considered available information
                                              objection to any aspect of this regulation              ppm, and fruiting vegetable crop group                concerning the variability of the
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                                              and may also request a hearing on those                 8–10 at 0.2 ppm. Then in the Federal                  sensitivities of major identifiable
                                              objections. You must file your objection                Register of September 15, 2017 (82 FR                 subgroups of consumers, including
                                              or request a hearing on this regulation                 43352) (FRL–9965–43), EPA issued                      infants and children.
                                              in accordance with the instructions                     another document pursuant to FFDCA                       Cyflufenamid has low acute toxicity
                                              provided in 40 CFR part 178. To ensure                  section 408(d)(3), 21 U.S.C. 346a(d)(3),              via the oral, dermal, and inhalation
                                              proper receipt by EPA, you must                         announcing that this petition also                    routes of exposure. Though slightly
                                              identify docket ID number EPA–HQ–                       requested the amendment of the existing               irritating to the eye, cyflufenamid is not


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                                                                 Federal Register / Vol. 83, No. 28 / Friday, February 9, 2018 / Rules and Regulations                                          5713

                                              a skin irritant or sensitizer. In the                   decreased body weight and incomplete                  mg/kg/day) will adequately account for
                                              mammalian toxicology database, the                      ossification were observed in rabbits,                all chronic toxicity, including
                                              liver was the primary target organ for                  those effects occurred at doses higher                carcinogenicity (which occurred only at
                                              cyflufenamid toxicity. Across species,                  than doses resulting in maternal effects              a dose over 5000x higher than the cRfD)
                                              duration and gender, changes in weight,                 and are believed to be related to                     that could result from exposure to
                                              clinical chemistry, and pathology                       maternal toxicity. Furthermore, the                   cyflufenamid.
                                              indicated treatment-related                             current PODs are protective of the                       Specific information on the studies
                                              perturbations in and adverse effects on                 effects seen on reproductive parameters               received and the nature of the adverse
                                              liver function.                                         in offspring. In addition, mating                     effects caused by cyflufenamid as well
                                                 Thyroid effects due to treatment with                performance and fertility in the Parent/              as the no-observed-adverse-effect-level
                                              cyflufenamid, seen only in the rat,                     Filial (P/F)0 generation were both                    (NOAEL) and the LOAEL from the
                                              included increased follicular cell                      unaffected by treatment with                          toxicity studies can be found at http://
                                              hypertrophy (as well as increased organ                 cyflufenamid in the 2-generation                      www.regulations.gov in document:
                                              weight) and neoplastic thyroid follicular               reproductive toxicity study in rats. Sex              ‘‘Cyflufenamid. Human Health Risk
                                              adenomas. Kidney effects related to                     ratio, sexual maturation, estrous
                                                                                                                                                            Assessment for Proposed Uses on
                                              treatment included increased kidney                     cyclicity, sperm quantity and quality,
                                                                                                                                                            Fruiting Vegetable Group 8–10, Cherry
                                              weight accompanied by tubular                           mating performance and fertility,
                                              vacuolation and slight decreases in                                                                           crop Subgroup 12–12A, and Hops; and
                                                                                                      gestation and viability indices in the
                                              sodium and chloride concentrations.                                                                           a Revised Tolerance on Cucurbit
                                                                                                      filial 1 (F1) generation were all
                                                 Treatment-related cardiotoxicity was                                                                       Vegetable Group 9’’ on page 16 in
                                                                                                      unaffected by treatment.
                                              noted in the rat and mouse feeding                         When tolerances were last established              docket ID number EPA–HQ–OPP–2016–
                                              studies. Observed myocardial                            for cyflufenamid (77 FR 38204, June 27,               0649.
                                              vacuolation and lipidosis may be                        2012), EPA had classified cyflufenamid                B. Toxicological Points of Departure/
                                              attributed to decreased lipid                           as ‘‘likely to be carcinogenic to humans’’            Levels of Concern
                                              metabolism; cyflufenamid caused an                      based on the presence of thyroid
                                              approximately 50% inhibition of                         follicular cell tumors in male rats and                  Once a pesticide’s toxicological
                                              carnitine palmitoyltransferase in both                  liver tumors in male mice. Since that                 profile is determined, EPA identifies
                                              rat and mouse heart microsomal                          time, EPA has reevaluated the                         toxicological POD and levels of concern
                                              fractions in a non-guideline mechanistic                carcinogenic potential of cyflufenamid                to use in evaluating the risk posed by
                                              study. Carnitine palmitoyltransferase is                and based on available data has                       human exposure to the pesticide. For
                                              involved in the transport of long chain                 reclassified cyflufenamid as having                   hazards that have a threshold below
                                              fatty acids into the mitochondrial matrix               ‘‘suggestive evidence of                              which there is no appreciable risk, the
                                              for oxidation. Fatty acid oxidation is an               carcinogenicity.’’ A well-established                 toxicological POD is used as the basis
                                              important source of energy for                          non-mutagenic mode of action (MOA)                    for derivation of reference values for
                                              adenosine triphosphate (ATP)                            for thyroid follicular cell tumors in male            risk assessment. PODs are based on a
                                              production in the mitochondria.                         rats was tested and found acceptable. In              careful analysis of each toxicological
                                                 Cyflufenamid-induced brain                           summary, EPA has determined that                      study to determine the values of the
                                              vacuolation was specific to the dog and                 because of the thyroid hormone                        NOAEL and the LOAEL. Uncertainty/
                                              not associated with any apparent                        imbalance, thyroid follicular cell tumors             safety factors are used in conjunction
                                              clinical sign of neurotoxicity.                         in male rats are likely to occur. That                with the POD to calculate a safe
                                              Supplementary studies investigating                     lead to an increase in the size                       exposure level—generally referred to as
                                              this phenomenon determined that                         (hypertrophy) and number (hyperplasia)                a population-adjusted dose (PAD) or a
                                              vacuolation was due to myelin edema                     of the thyroid follicular cells and                   reference dose (RfD)—and a safe margin
                                              affecting the white matter of the                       eventually to thyroid neoplasia (or                   of exposure (MOE). For non-threshold
                                              cerebrum and thalamus. Furthermore,                     tumors). Because of marked quantitative               risks, the Agency assumes that any
                                              this brain lesion was partially reversed                differences between rats and humans in                amount of exposure will lead to some
                                              after a 13-week recovery period                         their inherent susceptibility for thyroid             degree of risk. Thus, the Agency
                                              (following 90-day exposure) and fully                   tumors in response to an imbalance in                 estimates risk in terms of the probability
                                              reversed after a 26-week recovery                       thyroid hormones, EPA concludes that                  of an occurrence of the adverse effect
                                              period. This effect was not observed in                 cyflufenamid is not likely to pose a risk             expected in a lifetime. For more
                                              any other species. A subchronic                         for thyroid follicular cell tumors in                 information on the general principles
                                              neurotoxicity study in rats showed no                   humans. As a result, the database                     EPA uses in risk characterization and a
                                              evidence of neurotoxicity.                              contains the following data concerning                complete description of the risk
                                                 Effects on reproductive organs and/or                carcinogenicity: (1) There is no evidence             assessment process, see http://
                                              parameters have been previously noted                   of carcinogenicity in female rats and                 www2.epa.gov/pesticide-science-and-
                                              in several subchronic studies; however,                 mice; (2) the MOA data indicates that                 assessing-pesticide-risks/assessing-
                                              the effects occurred at doses above the                 thyroid follicular cell tumors may not be             human-health-risk-pesticides.
                                              respective lowest observed adverse                      relevant to humans; (3) tumors were                      A summary of the toxicological
                                              effect level (LOAELs) from the studies                  only found in the liver in one gender of              endpoints for cyflufenamid used for
                                              used to derive the point of departures                  one species, i.e., male mice; and (4)                 human risk assessment is shown in the
                                              (POD)s. The PODs are protective of                      there is no concern for mutagenicity or               Table of this unit.
                                              these effects. The developmental studies                clastogenicity based on the results of the
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                                              in rats and rabbits do not indicate any                 battery of genotoxicity studies.                      Table Summary of Points of Departure
                                              concern for increased susceptibility to                 Therefore, EPA concludes that the                     and Toxicity Endpoints Used in Human
                                              offspring. Although offspring effects of                chronic reference dose (cRfD) (0.044                  Risk Assessment




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                                              5714               Federal Register / Vol. 83, No. 28 / Friday, February 9, 2018 / Rules and Regulations

                                                         TABLE—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR CYFLUFENAMID FOR USE IN DIETARY,
                                                                  NON-OCCUPATIONAL AND OCCUPATIONAL HUMAN HEALTH RISK ASSESSMENTS
                                                                                                                                   RfD, PAD, level
                                                        Exposure/                      Point of         Uncertainty/FQPA             of concern for               Study and toxicological effects
                                                         scenario                     departure           safety factors           risk dssessment

                                              Acute Dietary (All Popu-          There were no appropriate toxicological effects attributable to a single exposure (dose) observed in appropriate
                                                lations).                       toxicity studies. Therefore, a dose and endpoint were not identified for this risk assessment.

                                              Chronic Dietary (All Popu-        NOAEL = 4.4 mg/         UFA = 10x              Chronic RfD =           Combined Chronic Toxicity/Carcinogenicity Study in
                                                lations).                        kg/day                 UFH = 10x                0.044 mg/kg/            Rats.
                                                                                                        FQPA SF = 1x             day                   LOAEL = 22 mg/kg/day based on increased thyroid/
                                                                                                                               cPAD = 0.044              parathyroid weight, increased liver weight and
                                                                                                                                 mg/kg/day               centrilobular hepatocytic hypertrophy.

                                              Dermal Short-Term (1–30           No adverse effects were observed in the dermal toxicity study and there are no concerns for developmental or
                                                days) and Intermediate-         neurological toxicities; therefore, no hazards are expected from these exposure scenarios.
                                                Term (1–6 months).

                                              Inhalation Short-Term (1–30       NOAEL = 5 mg/           UFA = 10x              Residential/Occu-       Prenatal Developmental Study in Rabbits.
                                                days) and Intermediate-          kg/day                 UFH = 10x                pational LOC          Maternal LOAEL = 10 mg/kg/day based on de-
                                                Term (1–6 months).                                      FQPA SF = 1x             for MOE = 100           creased body weight, body weight gains and food
                                                                                                                                                         consumption.

                                              Cancer (oral, dermal, inha-       Classification: ‘‘Suggestive evidence of carcinogenic potential’’ and quantification of risk using a non-linear ap-
                                                lation).                        proach (i.e., RfD approach) is appropriate.
                                                Point of Departure (POD) = A data point or an estimated point that is derived from observed dose-response data and used to mark the begin-
                                              ning 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 ad-
                                              justed dose (a = acute, c = chronic). RfD = reference dose. MOE = margin of exposure. LOC = level of concern.


                                              C. Exposure Assessment                                  was assessed using the same exposure                   effects attributable to a single exposure
                                                 1. Dietary exposure from food and                    estimates as discussed in Unit III.C.1.ii.,            to cyflufenamid have been identified;
                                              feed uses. In evaluating dietary                        chronic exposure.                                      therefore, an acute reference dose (aRfD)
                                                                                                         iv. Anticipated residue and percent                 has not been established and an acute
                                              exposure to cyflufenamid, EPA
                                                                                                      crop treated (PCT) information. EPA did                dietary exposure assessment was not
                                              considered exposure under the
                                                                                                      not use anticipated residue and PCT                    conducted. For chronic and cancer
                                              petitioned-for tolerances as well as all
                                                                                                      information in the dietary assessment                  dietary risk assessments, the ground
                                              existing cyflufenamid tolerances in 40
                                                                                                      for cyflufenamid. Tolerance-level                      water concentration value of 29.6 ppb
                                              CFR 180.667. EPA assessed dietary                       residues and 100% CT were assumed
                                              exposures from cyflufenamid in food as                                                                         was used to assess the contribution to
                                                                                                      for all food commodities.                              drinking water.
                                              follows:                                                   2. Dietary exposure from drinking
                                                 i. Acute exposure. Quantitative acute                                                                          3. From non-dietary exposure. The
                                                                                                      water. The Agency used screening-level                 term ‘‘residential exposure’’ is used in
                                              dietary exposure and risk assessments                   water exposure models in the dietary
                                              are performed for a food-use pesticide,                                                                        this document to refer to non-
                                                                                                      exposure analysis and risk assessment                  occupational, non-dietary exposure
                                              if a toxicological study has indicated the              for cyflufenamid in drinking water.
                                              possibility of an effect of concern                                                                            (e.g., for lawn and garden pest control,
                                                                                                      These simulation models take into                      indoor pest control, termiticides, and
                                              occurring as a result of a 1-day or single              account data on the physical, chemical,
                                              exposure.                                                                                                      flea and tick control on pets).
                                                                                                      and fate/transport characteristics of
                                                 No such effects were identified in the               cyflufenamid. Further information                         Although the Agency previously
                                              toxicological studies for cyflufenamid;                 regarding EPA drinking water models                    assessed residential handler exposure
                                              therefore, a quantitative acute dietary                 used in pesticide exposure assessment                  and risk estimates from the use of
                                              exposure assessment is unnecessary.                     can be found at http://www2.epa.gov/                   cyflufenamid on ornamental use sites,
                                                 ii. Chronic exposure. In conducting                  pesticide-science-and-assessing-                       the Agency now assumes that
                                              the chronic dietary exposure assessment                 pesticide-risks/about-water-exposure-                  cyflufenamid is only used by
                                              EPA used the food consumption data                      models-used-pesticide.                                 commercial applicators based on
                                              from the U.S. Department of                                The Agency used Tier II surface water               labeling requiring handlers to use
                                              Agriculture’s National Health and                       and Tier I ground water simulations for                personal protective equipment (PPE).
                                              Nutrition Examination Survey, What We                   all proposed cyflufenamid uses and                     Therefore, the Agency concludes that
                                              Eat in America (USDA’s NHANES/                          label modifications. The estimated                     there are no residential handler
                                              WWEIA). As to residue levels in food,                   drinking water concentrations (EDWCs)                  exposures to assess.
                                              EPA assumed tolerance-level residues                    of cyflufenamid for chronic exposures                     The Agency has also determined that
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                                              and 100% crop treated (100% CT) for all                 are 1.15 parts per billion (ppb) for                   there are no post-application residential
                                              commodities.                                            surface water and 29.6 ppb for ground                  exposures to assess. Although there is a
                                                 iii. Cancer. Based on the data                       water.                                                 potential for residential dermal post-
                                              summarized in Unit III.A., EPA has                         Modeled estimates of drinking water                 application exposure from the existing
                                              concluded that a nonlinear RfD                          concentrations were directly entered                   uses of cyflufenamid, there is no
                                              approach is appropriate for assessing                   into the dietary exposure model. For                   adverse systemic hazard via the dermal
                                              cancer risk to cyflufenamid. Cancer risk                acute dietary risk assessment, no toxic                route of exposure. Moreover, there is no


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                                                                 Federal Register / Vol. 83, No. 28 / Friday, February 9, 2018 / Rules and Regulations                                         5715

                                              incidental oral exposure expected from                  generation rat reproduction study.                       1. Acute risk. An acute aggregate risk
                                              cyflufenamid use on ornamental plants.                  Neither the rat nor rabbit developmental              assessment takes into account acute
                                                 Therefore, the Agency has concluded                  studies identified teratogenic effects.               exposure estimates from dietary
                                              that there are no residential exposure                  The marginally higher incidence of                    consumption of food and drinking
                                              scenarios to aggregate with dietary                     incompletely ossified epiphyses and                   water. No adverse effect resulting from
                                              exposures for cyflufenamid.                             metacarpals/phalanges seen in rabbits                 a single oral exposure was identified
                                                 Further information regarding EPA                    may be associated with low fetal weight               and no acute dietary endpoint was
                                              standard assumptions and generic                        and are indicative of delayed embryo-                 selected. Therefore, cyflufenamid is not
                                              inputs for residential exposures may be                 fetal development. The combined                       expected to pose an acute risk.
                                              found at http://www2.epa.gov/pesticide-                 offspring effects of decreased body                      2. Chronic risk. Using the exposure
                                              science-and-assessing-pesticide-risks/                  weight and incomplete ossification are                assumptions described in this unit for
                                              standard-operating-procedures-                          believed to be related to the observed                chronic exposure, EPA has concluded
                                              residential-pesticide.                                  maternal toxicity. Furthermore, the                   that chronic exposure to cyflufenamid
                                                 4. Cumulative effects from substances                PODs selected for all exposure scenarios              from food and water will utilize 2.8% of
                                              with a common mechanism of toxicity.                    are lower than those doses causing                    the cPAD for the general U.S.
                                              Section 408(b)(2)(D)(v) of FFDCA                        adverse effects in offspring.                         population and 6.1% for children 1–2
                                              requires that, when considering whether                    There are no residual uncertainties                years old, the population group
                                              to establish, modify, or revoke a                       concerning pre- and postnatal toxicity                receiving the greatest exposure. Based
                                              tolerance, the Agency consider                          and no neurotoxicity concerns.                        on the explanation in Unit III.C.3.,
                                              ‘‘available information’’ concerning the                                                                      regarding the lack of residential use
                                                                                                         3. Conclusion. EPA has determined
                                              cumulative effects of a particular                                                                            patterns, chronic residential exposure to
                                                                                                      that reliable data show the safety of
                                              pesticide’s residues and ‘‘other                                                                              residues of cyflufenamid is not
                                                                                                      infants and children would be
                                              substances that have a common                                                                                 expected.
                                                                                                      adequately protected if the FQPA SF
                                              mechanism of toxicity.’’                                                                                         3. Short-term risk. A short-term
                                                 EPA has not found cyflufenamid to                    were reduced to 1X. That decision is
                                                                                                                                                            adverse effect was identified for
                                              share a common mechanism of toxicity                    based on the following findings:
                                                                                                                                                            inhalation and oral exposures; however,
                                              with any other substances, and                             i. The toxicity database for
                                                                                                                                                            cyflufenamid is not registered for any
                                              cyflufenamid does not appear to                         cyflufenamid is complete.                             use patterns that would result in short-
                                              produce a toxic metabolite produced by                     ii. There is no indication that                    term residential exposure. Short-term
                                              other substances. For the purposes of                   cyflufenamid is a neurotoxic chemical                 risk is assessed based on short-term
                                              this tolerance action, therefore, EPA has               and there is no need for a                            residential exposure plus chronic
                                              assumed that cyflufenamid does not                      developmental neurotoxicity study or                  dietary exposure. Because there is no
                                              have a common mechanism of toxicity                     additional UFs to account for                         short-term residential exposure and
                                              with other substances. For information                  neurotoxicity.                                        chronic dietary exposure has already
                                              regarding EPA’s efforts to determine                       iii. There is no evidence that                     been assessed under the appropriately
                                              which chemicals have a common                           cyflufenamid results in increased                     protective cPAD (which is at least as
                                              mechanism of toxicity and to evaluate                   susceptibility in in utero rats or rabbits            protective as the POD used to assess
                                              the cumulative effects of such                          in the prenatal developmental studies or              short-term risk), no further assessment
                                              chemicals, see EPA’s website at http://                 in young rats in the 2-generation                     of short-term risk is necessary, and EPA
                                              www2.epa.gov/pesticide-science-and-                     reproduction study.                                   relies on the chronic dietary risk
                                              assessing-pesticide-risks/cumulative-                      iv. There are no residual uncertainties            assessment for evaluating short-term
                                              assessment-risk-pesticides.                             identified in the exposure databases.                 risk for cyflufenamid.
                                                                                                      The dietary food exposure assessments                    4. Intermediate-term risk. An
                                              D. Safety Factor for Infants and                        were performed based on 100% CT and                   intermediate-term adverse effect was
                                              Children                                                tolerance-level residues. EPA made                    identified; however, cyflufenamid is not
                                                1. In general. Section 408(b)(2)(C) of                conservative (protective) assumptions in              registered for any use patterns that
                                              FFDCA provides that EPA shall apply                     the ground and surface water modeling                 would result in intermediate-term
                                              an additional tenfold (10X) margin of                   used to assess exposure to cyflufenamid               residential exposure. Intermediate-term
                                              safety for infants and children in the                  in drinking water. These assessments                  risk is assessed based on intermediate-
                                              case of threshold effects to account for                will not underestimate the exposure and               term residential exposure plus chronic
                                              prenatal and postnatal toxicity and the                 risks posed by cyflufenamid.                          dietary exposure. Because there is no
                                              completeness of the database on toxicity                                                                      intermediate-term residential exposure
                                                                                                      E. Aggregate Risks and Determination of
                                              and exposure unless EPA determines                                                                            and chronic dietary exposure has
                                                                                                      Safety
                                              based on reliable data that a different                                                                       already been assessed under the
                                              margin of safety will be safe for infants                 EPA determines whether acute and                    appropriately protective cPAD (which is
                                              and children. This additional margin of                 chronic dietary pesticide exposures are               at least as protective as the POD used to
                                              safety is commonly referred to as the                   safe by comparing aggregate exposure                  assess intermediate-term risk), no
                                              Food Quality Protection Act Safety                      estimates to the acute population                     further assessment of intermediate-term
                                              Factor (FQPA SF). In applying this                      adjusted dose (aPAD) and chronic PAD                  risk is necessary, and EPA relies on the
                                              provision, EPA either retains the default               (cPAD). For linear cancer risks, EPA                  chronic dietary risk assessment for
                                              value of 10X, or uses a different                       calculates the lifetime probability of                evaluating intermediate-term risk for
                                              additional safety factor when reliable                  acquiring cancer given the estimated                  cyflufenamid.
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                                              data available to EPA support the choice                aggregate exposure. Short-,                              5. Aggregate cancer risk for U.S.
                                              of a different factor.                                  intermediate-, and chronic-term risks                 population. EPA has determined that
                                                2. Prenatal and postnatal sensitivity.                are evaluated by comparing the                        quantification of risk using the RfD
                                              There is no evidence of susceptibility                  estimated aggregate food, water, and                  approach is appropriate and will
                                              following in utero and/or postnatal                     residential exposure to the appropriate               adequately account for all chronic
                                              exposure in the developmental toxicity                  PODs to ensure that an adequate MOE                   toxicity, including carcinogenicity, that
                                              studies in rats or rabbits, and in the 2-               exists.                                               could result from exposure to


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                                              5716               Federal Register / Vol. 83, No. 28 / Friday, February 9, 2018 / Rules and Regulations

                                              cyflufenamid. Based on the conclusions                  concerns with cyflufenamid nor did any                this action is not subject to Executive
                                              of the chronic dietary assessment, EPA                  commenters provide supporting                         Order 13211, entitled ‘‘Actions
                                              concludes that exposure to                              information for the Agency to evaluate                Concerning Regulations That
                                              cyflufenamid is unlikely to pose an                     or on which the Agency could rely to                  Significantly Affect Energy Supply,
                                              aggregate cancer risk.                                  support a finding on the petitioned-for               Distribution, or Use’’ (66 FR 28355, May
                                                 6. Determination of safety. Based on                 tolerances.                                           22, 2001) or Executive Order 13045,
                                              these risk assessments, EPA concludes                      EPA recognizes that some individuals               entitled ‘‘Protection of Children from
                                              that there is a reasonable certainty that               believe that pesticides should be banned              Environmental Health Risks and Safety
                                              no harm will result to the general                      on agricultural crops. The existing legal             Risks’’ (62 FR 19885, April 23, 1997)),
                                              population, or to infants and children                  framework provided by section 408 of                  or Executive Order 13771, entitled
                                              from aggregate exposure to cyflufenamid                 the Federal Food, Drug, and Cosmetic                  ‘‘Reducing Regulations and Controlling
                                              residues.                                               Act (FFDCA), however, states that                     Regulatory Costs’’ (82 FR 9339, February
                                                                                                      tolerances may be set when persons                    3, 2017). This action does not contain
                                              IV. Other Considerations                                seeking such tolerances or exemptions                 any information collections subject to
                                              A. Analytical Enforcement Methodology                   have demonstrated that the pesticide                  OMB approval under the Paperwork
                                                                                                      meets the safety standard imposed by                  Reduction Act (PRA) (44 U.S.C. 3501 et
                                                 Adequate enforcement methodology
                                                                                                      that statute. EPA has assessed the effects            seq.), nor does it require any special
                                              (High-Performance Liquid
                                                                                                      of cyflufenamid on human health and                   considerations under Executive Order
                                              Chromatography Method with tandem
                                                                                                      determined that aggregate exposure to it              12898, entitled ‘‘Federal Actions to
                                              mass spectrometry detection (LC/MS/
                                                                                                      will be safe. These comments provide                  Address Environmental Justice in
                                              MS), Method No. RD–01307) is available
                                                                                                      no information to support an alternative              Minority Populations and Low-Income
                                              to enforce the tolerance expression. The
                                                                                                      conclusion.                                           Populations’’ (59 FR 7629, February 16,
                                              method may be requested from: Chief,                       As noted in Unit III.C.4., Congress has
                                              Analytical Chemistry Branch,                                                                                  1994).
                                                                                                      directed EPA to consider the cumulative                  Since tolerances and exemptions that
                                              Environmental Science Center, 701                       risk of pesticide residues with residues
                                              Mapes Rd., Ft. Meade, MD 20755–5350;                                                                          are established on the basis of a petition
                                                                                                      of ‘‘other substances that have a                     under FFDCA section 408(d), such as
                                              telephone number: (410) 305–2905;                       common mechanism of toxicity.’’
                                              email address: residuemethods@                                                                                the tolerance in this final rule, do not
                                                                                                      FFDCA section 408(b)(2)(D)(v). At this                require the issuance of a proposed rule,
                                              epa.gov.                                                time, EPA has not concluded that                      the requirements of the Regulatory
                                              B. International Residue Limits                         cyflufenamid has a common mechanism                   Flexibility Act (RFA) (5 U.S.C. 601 et
                                                                                                      of toxicity with any other pesticides.                seq.), do not apply.
                                                 In making its tolerance decisions, EPA
                                                                                                      The petitioner has not provided any                      This action directly regulates growers,
                                              seeks to harmonize U.S. tolerances with
                                                                                                      other information to support a different              food processors, food handlers, and food
                                              international standards whenever
                                                                                                      conclusion.                                           retailers, not States or tribes, nor does
                                              possible, consistent with U.S. food
                                              safety standards and agricultural                       D. Revisions to Petitioned-for                        this action alter the relationships or
                                              practices. EPA considers the                            Tolerances                                            distribution of power and
                                              international maximum residue limits                                                                          responsibilities established by Congress
                                                                                                         EPA is establishing tolerances that
                                              (MRLs) established by the Codex                                                                               in the preemption provisions of FFDCA
                                                                                                      vary slightly from requests in the
                                              Alimentarius Commission (Codex), as                                                                           section 408(n)(4). As such, the Agency
                                                                                                      petition by adding another significant
                                              required by FFDCA section 408(b)(4).                                                                          has determined that this action will not
                                                                                                      figure to the tolerance levels for
                                              The Codex Alimentarius is a joint                                                                             have a substantial direct effect on States
                                                                                                      subgroup 12–12A and group 8–10 and
                                              United Nations Food and Agriculture                                                                           or tribal governments, on the
                                                                                                      revising commodity term for hops to
                                              Organization/World Health                                                                                     relationship between the national
                                                                                                      match the Agency’s commodity
                                              Organization food standards program,                                                                          government and the States or tribal
                                                                                                      vocabulary.
                                              and it is recognized as an international                                                                      governments, or on the distribution of
                                              food safety standards-setting                           V. Conclusion                                         power and responsibilities among the
                                              organization in trade agreements to                       Therefore, tolerances are established               various levels of government or between
                                              which the United States is a party. EPA                 for residues of cyflufenamid, in or on                the Federal Government and Indian
                                              may establish a tolerance that is                       cherry crop subgroup 12–12A at 0.60                   tribes. Thus, the Agency has determined
                                              different from a Codex MRL; however,                    ppm; hop, dried cones at 5.0 ppm; and                 that Executive Order 13132, entitled
                                              FFDCA section 408(b)(4) requires that                   fruiting vegetable group 8–10 at 0.20                 ‘‘Federalism’’ (64 FR 43255, August 10,
                                              EPA explain the reasons for departing                   ppm; and the tolerance for residues in                1999) and Executive Order 13175,
                                              from the Codex level. The Codex has not                 or on cucurbit vegetable group 9 is                   entitled ‘‘Consultation and Coordination
                                              established a MRL for cyflufenamid.                     increased to 0.10 ppm.                                with Indian Tribal Governments’’ (65 FR
                                                                                                                                                            67249, November 9, 2000) do not apply
                                              C. Response to Comments                                 VI. Statutory and Executive Order                     to this action. In addition, this action
                                                 Several comments were received on                    Reviews                                               does not impose any enforceable duty or
                                              the publication. While some comments                       This action establishes and amends                 contain any unfunded mandate as
                                              raised issues outside the scope of the                  tolerances under FFDCA section 408(d)                 described under Title II of the Unfunded
                                              FFDCA analysis, the remaining                           in response to a petition submitted to                Mandates Reform Act (UMRA) (2 U.S.C.
                                              comments primarily expressed general                    the Agency. The Office of Management                  1501 et seq.).
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                                              concerns about the potential health                     and Budget (OMB) has exempted these                      This action does not involve any
                                              effects of pesticides residues in or on                 types of actions from review under                    technical standards that would require
                                              food and one comment asked that the                     Executive Order 12866, entitled                       Agency consideration of voluntary
                                              combined effects of multiple pesticides                 ‘‘Regulatory Planning and Review’’ (58                consensus standards pursuant to section
                                              be considered on food commodities.                      FR 51735, October 4, 1993). Because                   12(d) of the National Technology
                                              None of the comments specifically                       this action has been exempted from                    Transfer and Advancement Act
                                              mentioned any particular safety                         review under Executive Order 12866,                   (NTTAA) (15 U.S.C. 272 note).


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                                                                    Federal Register / Vol. 83, No. 28 / Friday, February 9, 2018 / Rules and Regulations                                           5717

                                              VII. Congressional Review Act                                ENVIRONMENTAL PROTECTION                             determine whether this document
                                                                                                           AGENCY                                               applies to them. Potentially affected
                                                Pursuant to the Congressional Review                                                                            entities may include:
                                              Act (5 U.S.C. 801 et seq.), EPA will                         40 CFR Part 180                                        • Crop production (NAICS code 111).
                                              submit a report containing this rule and                                                                            • Animal production (NAICS code
                                                                                                           [EPA–HQ–OPP–2016–0681; FRL–9972–69]
                                              other required information to the U.S.                                                                            112).
                                              Senate, the U.S. House of                                    Zoxamide; Pesticide Tolerances                         • Food manufacturing (NAICS code
                                              Representatives, and the Comptroller                                                                              311).
                                              General of the United States prior to                        AGENCY:  Environmental Protection                      • Pesticide manufacturing (NAICS
                                              publication of the rule in the Federal                       Agency (EPA).                                        code 32532).
                                              Register. This action is not a ‘‘major                       ACTION: Final rule.                                  B. How can I get electronic access to
                                              rule’’ as defined by 5 U.S.C. 804(2).                                                                             other related information?
                                                                                                           SUMMARY:  This regulation establishes
                                              List of Subjects in 40 CFR Part 180                          tolerances for residues of zoxamide in or               You may access a frequently updated
                                                                                                           on banana. Gowan Company, LLC                        electronic version of EPA’s tolerance
                                                Environmental protection,                                  requested these tolerances under the                 regulations at 40 CFR part 180 through
                                              Administrative practice and procedure,                       Federal Food, Drug, and Cosmetic Act                 the Government Printing Office’s e-CFR
                                              Agricultural commodities, Pesticides                         (FFDCA).                                             site at http://www.ecfr.gov/cgi-bin/text-
                                              and pests, Reporting and recordkeeping                                                                            idx?&c=ecfr&tpl=/ecfrbrowse/Title40/
                                                                                                           DATES:  This regulation is effective
                                              requirements.                                                                                                     40tab_02.tpl.
                                                                                                           February 9, 2018. Objections and
                                                Dated: January 24, 2018.                                   requests for hearings must be received               C. How can I file an objection or hearing
                                              Michael Goodis,                                              on or before April 10, 2018, and must                request?
                                              Director, Registration Division, Office of                   be filed in accordance with the                        Under FFDCA section 408(g), 21
                                              Pesticide Programs.                                          instructions provided in 40 CFR part                 U.S.C. 346a, any person may file an
                                                                                                           178 (see also Unit I.C. of the                       objection to any aspect of this regulation
                                                Therefore, 40 CFR chapter I is                             SUPPLEMENTARY INFORMATION).
                                              amended as follows:                                                                                               and may also request a hearing on those
                                                                                                           ADDRESSES: The docket for this action,               objections. You must file your objection
                                              PART 180—[AMENDED]                                           identified by docket identification (ID)             or request a hearing on this regulation
                                                                                                           number EPA–HQ–OPP–2016–0681, is                      in accordance with the instructions
                                                                                                           available at http://www.regulations.gov              provided in 40 CFR part 178. To ensure
                                              ■ 1. The authority citation for part 180
                                                                                                           or at the Office of Pesticide Programs               proper receipt by EPA, you must
                                              continues to read as follows:
                                                                                                           Regulatory Public Docket (OPP Docket)                identify docket ID number EPA–HQ–
                                                  Authority: 21 U.S.C. 321(q), 346a and 371.               in the Environmental Protection Agency               OPP–2016–0681 in the subject line on
                                              ■  2. In § 180.667, amend the table in                       Docket Center (EPA/DC), West William                 the first page of your submission. All
                                              paragraph (a) by:                                            Jefferson Clinton Bldg., Rm. 3334, 1301              objections and requests for a hearing
                                                                                                           Constitution Ave. NW, Washington, DC                 must be in writing, and must be
                                              ■ i. Adding alphabetically the                               20460–0001. The Public Reading Room                  received by the Hearing Clerk on or
                                              commodities ‘‘Cherry subgroup 12–                            is open from 8:30 a.m. to 4:30 p.m.,                 before April 10, 2018. Addresses for
                                              12A’’, ‘‘Hop, dried cones’’, and                             Monday through Friday, excluding legal               mail and hand delivery of objections
                                              ‘‘Vegetable, fruiting, group 8–10’’, and                     holidays. The telephone number for the               and hearing requests are provided in 40
                                              ■ ii. Revising the commodity                                 Public Reading Room is (202) 566–1744,               CFR 178.25(b).
                                              ‘‘Vegetable, cucurbit, group 9’’.                            and the telephone number for the OPP                   In addition to filing an objection or
                                                                                                           Docket is (703) 305–5805. Please review              hearing request with the Hearing Clerk
                                                 The additions and revisions read as                       the visitor instructions and additional
                                              follows:                                                                                                          as described in 40 CFR part 178, please
                                                                                                           information about the docket available               submit a copy of the filing (excluding
                                              § 180.667       Cyflufenamid; tolerances for                 at http://www.epa.gov/dockets.                       any Confidential Business Information
                                              residues.                                                    FOR FURTHER INFORMATION CONTACT:                     (CBI)) for inclusion in the public docket.
                                                                                                           Michael L. Goodis, P.E., Director,                   Information not marked confidential
                                                  (a) * * *                                                Registration Division (7505P), Office of             pursuant to 40 CFR part 2 may be
                                                                                                           Pesticide Programs, Environmental                    disclosed publicly by EPA without prior
                                                                                            Parts per
                                                              Commodity                      million       Protection Agency, 1200 Pennsylvania                 notice. Submit the non-CBI copy of your
                                                                                                           Ave. NW, Washington, DC 20460–0001;                  objection or hearing request, identified
                                                                                                           main telephone number: (703) 305–                    by docket ID number EPA–HQ–OPP–
                                              *           *           *           *          *             7090; email address: RDFRNotices@                    2016–0681, by one of the following
                                                                                                           epa.gov.                                             methods:
                                              Cherry subgroup 12–12A .............                  0.60                                                          • Federal eRulemaking Portal: http://
                                                                                                           SUPPLEMENTARY INFORMATION:
                                                                                                                                                                www.regulations.gov. Follow the online
                                              *           *           *           *          *             I. General Information                               instructions for submitting comments.
                                                                                                                                                                Do not submit electronically any
                                                                                                           A. Does this action apply to me?
                                              Hop, dried cones ..........................            5.0                                                        information you consider to be CBI or
                                              Vegetable, cucurbit, group 9 ........                 0.10      You may be potentially affected by                other information whose disclosure is
sradovich on DSK3GMQ082PROD with RULES




                                              Vegetable, fruiting, group 8–10 ....                  0.20   this action if you are an agricultural               restricted by statute.
                                                                                                           producer, food manufacturer, or                        • Mail: OPP Docket, Environmental
                                              *      *        *       *      *                             pesticide manufacturer. The following                Protection Agency Docket Center (EPA/
                                              [FR Doc. 2018–02670 Filed 2–8–18; 8:45 am]                   list of North American Industrial                    DC), (28221T), 1200 Pennsylvania Ave.
                                              BILLING CODE 6560–50–P                                       Classification System (NAICS) codes is               NW, Washington, DC 20460–0001.
                                                                                                           not intended to be exhaustive, but rather              • Hand Delivery: To make special
                                                                                                           provides a guide to help readers                     arrangements for hand delivery or


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Document Created: 2018-02-09 00:12:06
Document Modified: 2018-02-09 00:12:06
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionRules and Regulations
ActionFinal rule.
DatesThis 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).
ContactMichael Goodis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; main telephone
FR Citation83 FR 5711 
CFR AssociatedEnvironmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements

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