82_FR_36234 82 FR 36086 - Ethaboxam; Pesticide Tolerances

82 FR 36086 - Ethaboxam; Pesticide Tolerances

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 82, Issue 148 (August 3, 2017)

Page Range36086-36090
FR Document2017-16371

This regulation establishes tolerances for residues of ethaboxam in or on Ginseng; Pepper/eggplant, subgroup 8-10B; Vegetable, cucurbit, group 9; and Vegetable, tuberous and corm, subgroup 1C. Valent USA Corporation requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

Federal Register, Volume 82 Issue 148 (Thursday, August 3, 2017)
[Federal Register Volume 82, Number 148 (Thursday, August 3, 2017)]
[Rules and Regulations]
[Pages 36086-36090]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-16371]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2015-0676; FRL-9961-69]


Ethaboxam; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
ethaboxam in or on Ginseng; Pepper/eggplant, subgroup 8-10B; Vegetable, 
cucurbit, group 9; and Vegetable, tuberous and corm, subgroup 1C. 
Valent USA Corporation requested these tolerances under the Federal 
Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective August 3, 2017. Objections and 
requests for hearings must be received on or before October 2, 2017, 
and must be filed in accordance with the instructions provided in 40 
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2015-0676, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory 
Public Docket (OPP Docket) in the Environmental Protection Agency 
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 
1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public 
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through 
Friday, excluding legal holidays. The telephone number for the Public 
Reading Room is (202) 566-1744, and the telephone number for the OPP 
Docket is (703) 305-5805. Please review the visitor instructions and 
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Mike Goodis, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone 
number: (703) 305-7090; email address: [email protected].

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

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

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

    You may access a frequently updated electronic version of EPA's 
tolerance regulations at 40 CFR part 180 through the Government 
Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an 
objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2015-0676 in the subject line on the first 
page of your submission. All objections and requests for a hearing must 
be in writing, and must be received by the Hearing Clerk on or before 
October 2, 2017. Addresses for mail and hand delivery of objections and 
hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing (excluding any Confidential Business Information (CBI)) for 
inclusion in the public docket. Information not marked confidential 
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without 
prior notice. Submit the non-CBI copy of your objection or hearing 
request, identified by docket ID number EPA-HQ-OPP-2015-0676, 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 April 25, 2016 (81 FR 24044) (FRL-9944-
86), 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 
5F8383) by Valent USA Corporation, 1600 Riviera Avenue,

[[Page 36087]]

Suite 200, Walnut Creek, CA 94596. The petition requested that 40 CFR 
180.622 be amended by establishing tolerances for residues of the 
fungicide ethaboxam, N-(cyano-2-thienylmethyl)-4-ethyl-2-(ethlyamino)-
5-thiazolecarboxamide, in or on ginseng at 0.09 parts per million 
(ppm); Pepper/eggplant (Crop Subgroup 8-10B) at 0.6 ppm; Cucurbit 
Vegetables (Crop Group 9) at 0.3 ppm; and Tuberous and corm Vegetable 
Subgroup 1C at 0.01 ppm. That document referenced a summary of the 
petition prepared by Valent USA Corporation, the registrant, which is 
available in the docket, http://www.regulations.gov. There were no 
comments received in response to the notice of filing.
    Based upon review of the data supporting the petition, EPA has 
corrected proposed commodity definitions and revised certain proposed 
crop tolerances. The reasons for these changes are explained 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 ethaboxam including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with ethaboxam follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children.
    The toxicology database for ethaboxam is complete. The male 
reproductive system is a target for ethaboxam, with alterations to the 
male reproductive organs as well as functional effects on male 
reproduction observed in several oral subchronic and chronic rat 
studies. In subchronic studies in rats, there were severe testicular 
alterations including small testes, decreased testicular weight and 
atrophy, abnormal spermatids in the testes, and interstitial cell 
hyperplasia. In the epididymis, there were small epididymides, 
decreased epididymal weights, abnormal spermatogenic cells, and absent 
spermatozoa. Decreased seminal vesicle and prostate weights were also 
observed. Effects were also seen after chronic exposure including 
decreased epididymal and seminal vesicle weights, seminiferous tubule 
atrophy, small/flaccid testes and epididymides, abnormal spermatogenic 
cells in the epididymal duct, absent sperm, epididymal vacuolation, and 
reduced colloid in the prostate. Fine vacuolation of the adrenal zona 
glomerulosa was also observed in both sexes in the rat studies, along 
with decreased body weight in females. There were no treatment-related 
male reproductive effects observed in mice, but there were effects seen 
in the liver. In mice, increased liver weights associated with 
centrilobular hypertrophy and liver histopathology (eosinophilic foci) 
were observed after chronic exposure. In dogs, decreased body weight 
and body weight gain, decreased thymus weights and thymus atrophy/
involution, and hematopoiesis of the spleen were noted after subchronic 
exposure. No treatment-related effects were noted in dogs after chronic 
exposure. There is no concern for neurotoxicity or immunotoxicity after 
exposure to ethaboxam. No evidence of increased quantitative or 
qualitative susceptibility was seen in the developmental toxicity 
studies in rats and rabbits; however, increased qualitative 
susceptibility was seen in the rat reproduction study where decreased 
body weight, decreased viability, and delayed sexual maturation were 
seen in offspring animals in the presence of limited parental effects 
(decreased body weight and body weight gain). Ethaboxam is classified 
as having ``suggestive evidence of carcinogenic potential,'' based on 
an increased incidence of benign Leydig cell tumors in male rats. The 
Agency has determined that quantification of cancer risk using a non-
linear approach (based on the POD of 5.5 mg/kg/day for establishing a 
chronic reference dose) would adequately account for all chronic 
toxicity since the POD is 6-fold lower than the lowest dose that 
induced tumors.
    Specific information on the studies received and the nature of the 
adverse effects caused by ethaboxam as well as the no-observed-adverse-
effect-level (NOAEL) and the lowest-observed-adverse-effect-level 
(LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document ``Ethaboxam. Human Health Risk 
Assessment for the Proposed First Food Uses on Fruiting Vegetables 
(Pepper/Eggplant Subgroup 8-10B), Cucurbit Vegetables (Group 9), 
Ginseng, and Potato (Tuberous and Corm Vegetable Subgroup 1C)'' at 
pages 27-32 in docket ID number EPA-HQ-OPP-2015-0676.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological points of departure (POD) and levels of 
concern to use in evaluating the risk posed by human exposure to the 
pesticide. For hazards that have a threshold below which there is no 
appreciable risk, the toxicological POD is used as the basis for 
derivation of reference values for risk assessment. PODs are developed 
based on a careful analysis of the doses in each toxicological study to 
determine the dose at which no adverse effects are observed (the NOAEL) 
and the lowest dose at which adverse effects of concern are identified 
(the LOAEL). Uncertainty/safety factors are used in conjunction with 
the POD to calculate a safe exposure level--generally referred to as a 
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe 
margin of exposure (MOE). For non-threshold risks, the Agency assumes 
that any amount of exposure will lead to some degree of risk. Thus, the 
Agency estimates risk in terms of the probability of an occurrence of 
the adverse effect expected in a lifetime. For more information on the 
general principles EPA uses in risk characterization and a complete 
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for ethaboxam used for

[[Page 36088]]

human risk assessment is shown in the Table of this unit.

    Table--Summary of Toxicological Doses and Endpoints for Ethaboxam for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                    Point of departure
        Exposure/scenario            and uncertainty/     RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk  assessment
----------------------------------------------------------------------------------------------------------------
Acute dietary (All Populations)..  No appropriate endpoint attributable to a single dose identified.
----------------------------------------------------------------------------------------------------------------
Chronic dietary (All populations)  NOAEL= 5.5 mg/kg/day  Chronic RfD = 0.055  Combined Chronic/Carcinogenicity-
                                   UFA = 10x...........   mg/kg/day.           Rat.
                                   UFH = 10x...........  cPAD = 0.055 mg/kg/  LOAEL = 16.4 mg/kg/day based on
                                   FQPA SF = 1x........   day.                 effects observed in the male
                                                                               reproductive organs (testes,
                                                                               epididymides, prostate, seminal
                                                                               vesicles).
----------------------------------------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)  Classification: ``Suggestive Evidence of Carcinogenicity'', based on an
                                    increased incidence of benign Leydig Cell tumors in males. Cancer risk has
                                    been assessed using a non-linear approach.
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
  of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
  level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. FQPA SF = Food Quality
  Protection Act safety factor. UF = uncertainty factor. UFA = extrapolation from animal to human
  (interspecies). UFH = potential variation in sensitivity among members of the human population (intraspecies).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to ethaboxam, EPA considered exposure under the petitioned-for 
tolerances as well as all existing ethaboxam tolerances in 40 CFR 
180.622. EPA assessed dietary exposures from ethaboxam 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 
ethaboxam; 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 2003-2008 U.S. 
Department of Agriculture's (USDA's) National Health and Nutrition 
Examination Survey, What We Eat in America (NHANES/WWEIA). Tolerance-
level residues and 100% crop treated were assumed for all crops. 
Empirical data indicate that residues of ethaboxam in processed grape 
(e.g., juice, raisins, etc.) and potato (e.g., flakes, chips, etc.) 
commodities are not expected to exceed the tolerance level for grapes 
or potatoes; therefore, no concentration factors were used in this 
analysis.
    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 ethaboxam. 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/or PCT information in the 
dietary assessment for ethaboxam. Tolerance-level residues and/or 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 ethaboxam in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of ethaboxam. Further information regarding EPA 
drinking water models used in pesticide exposure assessment can be 
found at http://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the Pesticide in Water Calculator (PWC) v1.50 and 
Pesticide Root Zone Model Ground Water (PRZM GW), the estimated 
drinking water concentrations (EDWCs) of ethaboxam for chronic 
exposures for non-cancer assessments are estimated to be 3.91 ppb for 
surface water and 7.4 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For chronic dietary risk 
assessment, the water concentration of value 7.4 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).
    Ethaboxam is not registered for any specific use patterns that 
would result in residential exposure.
    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 ethaboxam to share a common mechanism of toxicity 
with any other substances, and ethaboxam does not appear to produce a 
toxic metabolite produced by other substances. For the purposes of this 
tolerance action, therefore, EPA has assumed that ethaboxam does not 
have a common mechanism of toxicity with other substances. For 
information regarding EPA's efforts to determine which chemicals have a 
common mechanism of toxicity and to evaluate the cumulative effects of 
such chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the

[[Page 36089]]

FQPA Safety Factor (SF). In applying this provision, EPA either retains 
the default value of 10X, or uses a different additional safety factor 
when reliable data available to EPA support the choice of a different 
factor.
    2. Prenatal and postnatal sensitivity. There is evidence of 
increased qualitative susceptibility in the rat developmental and 
reproduction studies. Considering the overall toxicity profile and the 
doses and endpoints selected for risk assessment for ethaboxam, the 
degree of concern for prenatal and postnatal effects observed in the 
studies is low based on the following: The developmental/offspring 
effects observed in the studies are well characterized and occur in the 
presence of maternal toxicity; a clear NOAEL has been identified in 
both of the studies; and there are no residual uncertainties for pre-
and/or postnatal toxicity. Furthermore, the toxicology endpoint 
established for risk assessment is based on a lower NOAEL than the 
reproductive NOAEL, and thus is considered protective of developmental/
offspring effects.
    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 ethaboxam is complete.
    ii. There is no indication that ethaboxam is a neurotoxic chemical 
and there is no need for a developmental neurotoxicity study or 
additional UFs to account for neurotoxicity.
    iii. Although there is evidence of increased qualitative 
susceptibility in the rat reproduction study, the offspring effects 
observed in the study are well characterized and clear NOAELs/LOAELs 
have been identified in the study for the effects of concern. 
Additionally, the points of departure (PODs) selected for risk 
assessment are protective of potential offspring effects.
    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 ethaboxam in drinking water. These assessments 
will not underestimate the exposure and risks posed by ethaboxam.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide 
exposures are safe by comparing aggregate exposure estimates to the 
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA 
calculates the lifetime probability of acquiring cancer given the 
estimated aggregate exposure. Short-, intermediate-, and chronic-term 
risks are evaluated by comparing the estimated aggregate food, water, 
and residential exposure to the appropriate PODs to ensure that an 
adequate MOE exists.
    1. Acute risk. 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, 
ethaboxam 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 
ethaboxam from food and water will utilize 36% of the cPAD for children 
1-2 years old the population group receiving the greatest exposure. 
There are no residential uses for ethaboxam.
    3. Short-term and intermediate-term risk. Short-term (and 
intermediate-term) aggregate exposure takes into account short-term 
(and intermediate-term) residential exposure plus chronic exposure to 
food and water (considered to be a background exposure level). Although 
short-term and intermediate-term adverse effects were identified, 
ethaboxam is not registered for any use patterns that would result in 
short-term or intermediate-term residential exposure. Because there is 
no 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 or intermediate-term 
risk), no further assessment of residential risk is necessary. EPA 
relies on the chronic dietary risk assessment for evaluating short-term 
and intermediate-term risk for ethaboxam.
    4. Aggregate cancer risk for U.S. population. As discussed in Unit 
III.A., EPA has determined that the chronic reference dose (cRfD) is 
protective of the potential cancer effects. Because chronic exposure 
does not exceed the Agency's level of concern, EPA concludes that 
ethaboxam does not pose a cancer risk.
    5. 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 ethaboxam residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology Liquid Chromotography with tandem 
mass spectrometrometry (LC-MS/MS) is available to enforce the tolerance 
expression.
    The method may be requested from: Chief, Analytical Chemistry 
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 
20755-5350; telephone number: (410) 305-2905; email address: 
[email protected].

B. International Residue Limits

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

C. Revisions to Petitioned-For Tolerances

    To reflect the correct commodity definitions, EPA revised the 
proposed commodity listings for Potato (Tuberous and Corm Vegetable 
Subgroup 1C); Peppers (Pepper/Eggplant Crop Subgroup 8-10B); and 
Cucurbit Vegetables (Crop Group 9) to Vegetable, tuberous and corm, 
subgroup 1C; Pepper/eggplant, subgroup 8-10B; and Vegetable, cucurbit, 
group 9, respectively.
    The petitioner requested that the tolerances for Pepper/eggplant, 
subgroup 8-10B be set at 0.6 ppm and Ginseng be set at 0.09 ppm; 
however, the Agency is establishing the tolerances at 0.90 ppm and 0.10 
ppm, respectively, based on Agency calculations using data obtained 
from the submitted residue studies. The Agency used the Organization of 
Economic Cooperation and Development (OECD) maximum residue limit (MRL) 
calculation

[[Page 36090]]

procedures to derive the recommended levels. For crop groups, and per 
EPA's current policy, a tolerance level for each representative 
commodity was calculated separately, and then the maximum value within 
each crop group was selected as the tolerance level.
    All of EPA's tolerance levels are expressed to provide sufficient 
precision for enforcement purposes. This may include the addition of 
trailing zeros, as was the case for Vegetable, cucurbit, group 9 for 
which a tolerance of 0.3 ppm was proposed and a tolerance at 0.30 ppm 
is being established.
    Finally, EPA is revising the tolerance expression to clarify (1) 
that, as provided in FFDCA section 408(a)(3), the tolerance covers 
metabolites and degradates of ethaboxam not specifically mentioned; and 
(2) that compliance with the specified tolerance levels is to be 
determined by measuring only the specific compounds mentioned in the 
tolerance expression.

V. Conclusion

    Therefore, tolerances are established for residues of ethaboxam (N-
(cyano-2-thienylmethyl)-4-ethyl-2-(ethlyamino)-5-thiazolecarboxamide), 
including its metabolites and degradates, in or on Ginseng at 0.10 ppm; 
Pepper/eggplant, subgroup 8-10B at 0.90 ppm; Vegetable, cucurbit, group 
9 at 0.30 ppm; and Vegetable, tuberous and corm, subgroup 1C at 0.01 
ppm. Compliance with the tolerance levels specified above is to be 
determined by measuring only ethaboxam (N-(cyano-2-thienylmethyl)-4-
ethyl-2-(ethlyamino)-5-thiazolecarboxamide).

VI. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA section 408(d) in 
response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled ``Regulatory Planning and 
Review'' (58 FR 51735, October 4, 1993). Because this action has been 
exempted from review under Executive Order 12866, this action is not 
subject to Executive Order 13211, entitled ``Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
``Protection of Children from Environmental Health Risks and Safety 
Risks'' (62 FR 19885, April 23, 1997). This action does not contain any 
information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any 
special considerations under Executive Order 12898, entitled ``Federal 
Actions to Address Environmental Justice in Minority Populations and 
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under FFDCA section 408(d), such as the tolerance in this 
final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.), do not apply.
    This action directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled ``Federalism'' (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
``Consultation and Coordination with Indian Tribal Governments'' (65 FR 
67249, November 9, 2000) do not apply to this action. In addition, this 
action does not impose any enforceable duty or contain any unfunded 
mandate as described under Title II of the Unfunded Mandates Reform Act 
(UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
EPA will submit a report containing this rule and other required 
information to the U.S. Senate, the U.S. House of Representatives, and 
the Comptroller General of the United States prior to publication of 
the rule in the Federal Register. This action is not a ``major rule'' 
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: June 29, 2017.
Donna Davis,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority:  21 U.S.C. 321(q), 346a and 371.


0
2. Section 180.622, paragraph (a) is revised to read as follows:


Sec.  180.622   Ethaboxam; tolerances for residues.

    (a) General. Tolerances are established for residues of ethaboxam, 
including its metabolites and degradates, in or on the commodities 
listed in the table below. Compliance with the tolerance levels 
specified below is to be determined by measuring only ethaboxam (N-
(cyano-2-thienylmethyl)-4-ethyl-2-(ethylamino)-5-thiazolecarboxamide) 
in or on the commodity.

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
Ginseng.................................................            0.10
Grape \1\...............................................             6.0
Pepper/eggplant subgroup 8-10B..........................            0.90
Vegetable, cucurbit, group 9............................            0.30
Vegetable, tuberous and corm, subgroup 1C...............            0.01
------------------------------------------------------------------------
\1\ There is no U.S. registration as of September 27, 2006.

* * * * *
[FR Doc. 2017-16371 Filed 8-2-17; 8:45 am]
BILLING CODE 6560-50-P



                                             36086                 Federal Register / Vol. 82, No. 148 / Thursday, August 3, 2017 / Rules and Regulations

                                                                                                                                                                                                                                              Diagnostic
                                                                                                                                                                                                                                              Code No.

                                                       *                                *                              *                               *                              *                              *                          *
                                                  Malignant:

                                                        *                    *                                 *                                 *                                 *                                *                           *
                                                        Hard and soft tissue ..............................................................................................................................................................          9918

                                                     *                   *                   *                               *                                 *                                *                                               *
                                             Nonunion:
                                                Mandible, confirmed by diagnostic imaging studies .....................................................................................................................                              9903

                                                         *                              *                              *                               *                              *                              *                          *



                                             [FR Doc. 2017–16132 Filed 8–2–17; 8:45 am]                             FOR FURTHER INFORMATION CONTACT:                                          OPP–2015–0676 in the subject line on
                                             BILLING CODE 8320–01–P                                                 Mike Goodis, Registration Division                                        the first page of your submission. All
                                                                                                                    (7505P), Office of Pesticide Programs,                                    objections and requests for a hearing
                                                                                                                    Environmental Protection Agency, 1200                                     must be in writing, and must be
                                             ENVIRONMENTAL PROTECTION                                               Pennsylvania Ave. NW., Washington,                                        received by the Hearing Clerk on or
                                             AGENCY                                                                 DC 20460–0001; main telephone                                             before October 2, 2017. Addresses for
                                                                                                                    number: (703) 305–7090; email address:                                    mail and hand delivery of objections
                                             40 CFR Part 180                                                        RDFRNotices@epa.gov.                                                      and hearing requests are provided in 40
                                                                                                                    SUPPLEMENTARY INFORMATION:                                                CFR 178.25(b).
                                             [EPA–HQ–OPP–2015–0676; FRL–9961–69]
                                                                                                                                                                                                In addition to filing an objection or
                                                                                                                    I. General Information                                                    hearing request with the Hearing Clerk
                                             Ethaboxam; Pesticide Tolerances
                                                                                                                    A. Does this action apply to me?                                          as described in 40 CFR part 178, please
                                             AGENCY:  Environmental Protection                                                                                                                submit a copy of the filing (excluding
                                             Agency (EPA).                                                             You may be potentially affected by                                     any Confidential Business Information
                                             ACTION: Final rule.
                                                                                                                    this action if you are an agricultural                                    (CBI)) for inclusion in the public docket.
                                                                                                                    producer, food manufacturer, or                                           Information not marked confidential
                                             SUMMARY:   This regulation establishes                                 pesticide manufacturer. The following                                     pursuant to 40 CFR part 2 may be
                                             tolerances for residues of ethaboxam in                                list of North American Industrial                                         disclosed publicly by EPA without prior
                                             or on Ginseng; Pepper/eggplant,                                        Classification System (NAICS) codes is                                    notice. Submit the non-CBI copy of your
                                             subgroup 8–10B; Vegetable, cucurbit,                                   not intended to be exhaustive, but rather                                 objection or hearing request, identified
                                             group 9; and Vegetable, tuberous and                                   provides a guide to help readers                                          by docket ID number EPA–HQ–OPP–
                                             corm, subgroup 1C. Valent USA                                          determine whether this document                                           2015–0676, by one of the following
                                             Corporation requested these tolerances                                 applies to them. Potentially affected                                     methods:
                                             under the Federal Food, Drug, and                                      entities may include:                                                       • Federal eRulemaking Portal: http://
                                             Cosmetic Act (FFDCA).                                                     • Crop production (NAICS code 111).                                    www.regulations.gov. Follow the online
                                             DATES: This regulation is effective                                       • Animal production (NAICS code                                        instructions for submitting comments.
                                             August 3, 2017. Objections and requests                                112).                                                                     Do not submit electronically any
                                             for hearings must be received on or                                       • Food manufacturing (NAICS code                                       information you consider to be CBI or
                                             before October 2, 2017, and must be                                    311).                                                                     other information whose disclosure is
                                             filed in accordance with the instructions                                 • Pesticide manufacturing (NAICS                                       restricted by statute.
                                             provided in 40 CFR part 178 (see also                                  code 32532).                                                                • Mail: OPP Docket, Environmental
                                             Unit I.C. of the SUPPLEMENTARY                                         B. How can I get electronic access to                                     Protection Agency Docket Center (EPA/
                                             INFORMATION).                                                                                                                                    DC), (28221T), 1200 Pennsylvania Ave.
                                                                                                                    other related information?
                                                                                                                                                                                              NW., Washington, DC 20460–0001.
                                             ADDRESSES:    The docket for this action,                                 You may access a frequently updated                                      • Hand Delivery: To make special
                                             identified by docket identification (ID)                               electronic version of EPA’s tolerance                                     arrangements for hand delivery or
                                             number EPA–HQ–OPP–2015–0676, is                                        regulations at 40 CFR part 180 through                                    delivery of boxed information, please
                                             available at http://www.regulations.gov                                the Government Printing Office’s e-CFR                                    follow the instructions at http://
                                             or at the Office of Pesticide Programs                                 site at http://www.ecfr.gov/cgi-bin/text-                                 www.epa.gov/dockets/contacts.html.
                                             Regulatory Public Docket (OPP Docket)                                  idx?&c=ecfr&tpl=/ecfrbrowse/Title40/                                      Additional instructions on commenting
                                             in the Environmental Protection Agency                                 40tab_02.tpl                                                              or visiting the docket, along with more
                                             Docket Center (EPA/DC), West William                                                                                                             information about dockets generally, is
                                             Jefferson Clinton Bldg., Rm. 3334, 1301                                C. How can I file an objection or hearing
                                                                                                                    request?                                                                  available at http://www.epa.gov/
                                             Constitution Ave. NW., Washington, DC                                                                                                            dockets.
                                             20460–0001. The Public Reading Room                                      Under FFDCA section 408(g), 21
                                             is open from 8:30 a.m. to 4:30 p.m.,                                   U.S.C. 346a, any person may file an                                       II. Summary of Petitioned-For
                                             Monday through Friday, excluding legal                                 objection to any aspect of this regulation                                Tolerance
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                                             holidays. The telephone number for the                                 and may also request a hearing on those                                      In the Federal Register of April 25,
                                             Public Reading Room is (202) 566–1744,                                 objections. You must file your objection                                  2016 (81 FR 24044) (FRL–9944–86),
                                             and the telephone number for the OPP                                   or request a hearing on this regulation                                   EPA issued a document pursuant to
                                             Docket is (703) 305–5805. Please review                                in accordance with the instructions                                       FFDCA section 408(d)(3), 21 U.S.C.
                                             the visitor instructions and additional                                provided in 40 CFR part 178. To ensure                                    346a(d)(3), announcing the filing of a
                                             information about the docket available                                 proper receipt by EPA, you must                                           pesticide petition (PP 5F8383) by Valent
                                             at http://www.epa.gov/dockets.                                         identify docket ID number EPA–HQ–                                         USA Corporation, 1600 Riviera Avenue,


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                                                               Federal Register / Vol. 82, No. 148 / Thursday, August 3, 2017 / Rules and Regulations                                        36087

                                             Suite 200, Walnut Creek, CA 94596. The                  completeness, and reliability as well as              having ‘‘suggestive evidence of
                                             petition requested that 40 CFR 180.622                  the relationship of the results of the                carcinogenic potential,’’ based on an
                                             be amended by establishing tolerances                   studies to human risk. EPA has also                   increased incidence of benign Leydig
                                             for residues of the fungicide ethaboxam,                considered available information                      cell tumors in male rats. The Agency
                                             N-(cyano-2-thienylmethyl)-4-ethyl-2-                    concerning the variability of the                     has determined that quantification of
                                             (ethlyamino)-5-thiazolecarboxamide, in                  sensitivities of major identifiable                   cancer risk using a non-linear approach
                                             or on ginseng at 0.09 parts per million                 subgroups of consumers, including                     (based on the POD of 5.5 mg/kg/day for
                                             (ppm); Pepper/eggplant (Crop Subgroup                   infants and children.                                 establishing a chronic reference dose)
                                             8–10B) at 0.6 ppm; Cucurbit Vegetables                     The toxicology database for                        would adequately account for all
                                             (Crop Group 9) at 0.3 ppm; and                          ethaboxam is complete. The male                       chronic toxicity since the POD is 6-fold
                                             Tuberous and corm Vegetable Subgroup                    reproductive system is a target for                   lower than the lowest dose that induced
                                             1C at 0.01 ppm. That document                           ethaboxam, with alterations to the male               tumors.
                                             referenced a summary of the petition                    reproductive organs as well as                           Specific information on the studies
                                             prepared by Valent USA Corporation,                     functional effects on male reproduction               received and the nature of the adverse
                                             the registrant, which is available in the               observed in several oral subchronic and               effects caused by ethaboxam as well as
                                             docket, http://www.regulations.gov.                     chronic rat studies. In subchronic                    the no-observed-adverse-effect-level
                                             There were no comments received in                      studies in rats, there were severe                    (NOAEL) and the lowest-observed-
                                             response to the notice of filing.                       testicular alterations including small                adverse-effect-level (LOAEL) from the
                                                Based upon review of the data                        testes, decreased testicular weight and               toxicity studies can be found at http://
                                             supporting the petition, EPA has                                                                              www.regulations.gov in document
                                                                                                     atrophy, abnormal spermatids in the
                                             corrected proposed commodity                                                                                  ‘‘Ethaboxam. Human Health Risk
                                                                                                     testes, and interstitial cell hyperplasia.
                                             definitions and revised certain proposed                                                                      Assessment for the Proposed First Food
                                                                                                     In the epididymis, there were small
                                             crop tolerances. The reasons for these                                                                        Uses on Fruiting Vegetables (Pepper/
                                                                                                     epididymides, decreased epididymal
                                             changes are explained in Unit IV.C.                                                                           Eggplant Subgroup 8–10B), Cucurbit
                                                                                                     weights, abnormal spermatogenic cells,
                                             III. Aggregate Risk Assessment and                      and absent spermatozoa. Decreased                     Vegetables (Group 9), Ginseng, and
                                             Determination of Safety                                 seminal vesicle and prostate weights                  Potato (Tuberous and Corm Vegetable
                                                Section 408(b)(2)(A)(i) of FFDCA                     were also observed. Effects were also                 Subgroup 1C)’’ at pages 27–32 in docket
                                             allows EPA to establish a tolerance (the                seen after chronic exposure including                 ID number EPA–HQ–OPP–2015–0676.
                                             legal limit for a pesticide chemical                    decreased epididymal and seminal                      B. Toxicological Points of Departure/
                                             residue in or on a food) only if EPA                    vesicle weights, seminiferous tubule                  Levels of Concern
                                             determines that the tolerance is ‘‘safe.’’              atrophy, small/flaccid testes and
                                             Section 408(b)(2)(A)(ii) of FFDCA                       epididymides, abnormal spermatogenic                     Once a pesticide’s toxicological
                                             defines ‘‘safe’’ to mean that ‘‘there is a              cells in the epididymal duct, absent                  profile is determined, EPA identifies
                                             reasonable certainty that no harm will                  sperm, epididymal vacuolation, and                    toxicological points of departure (POD)
                                             result from aggregate exposure to the                   reduced colloid in the prostate. Fine                 and levels of concern to use in
                                             pesticide chemical residue, including                   vacuolation of the adrenal zona                       evaluating the risk posed by human
                                             all anticipated dietary exposures and all               glomerulosa was also observed in both                 exposure to the pesticide. For hazards
                                             other exposures for which there is                      sexes in the rat studies, along with                  that have a threshold below which there
                                             reliable information.’’ This includes                   decreased body weight in females.                     is no appreciable risk, the toxicological
                                             exposure through drinking water and in                  There were no treatment-related male                  POD is used as the basis for derivation
                                             residential settings, but does not include              reproductive effects observed in mice,                of reference values for risk assessment.
                                             occupational exposure. Section                          but there were effects seen in the liver.             PODs are developed based on a careful
                                             408(b)(2)(C) of FFDCA requires EPA to                   In mice, increased liver weights                      analysis of the doses in each
                                             give special consideration to exposure                  associated with centrilobular                         toxicological study to determine the
                                             of infants and children to the pesticide                hypertrophy and liver histopathology                  dose at which no adverse effects are
                                             chemical residue in establishing a                      (eosinophilic foci) were observed after               observed (the NOAEL) and the lowest
                                             tolerance and to ‘‘ensure that there is a               chronic exposure. In dogs, decreased                  dose at which adverse effects of concern
                                             reasonable certainty that no harm will                  body weight and body weight gain,                     are identified (the LOAEL). Uncertainty/
                                             result to infants and children from                     decreased thymus weights and thymus                   safety factors are used in conjunction
                                             aggregate exposure to the pesticide                     atrophy/involution, and hematopoiesis                 with the POD to calculate a safe
                                             chemical residue. . . .’’                               of the spleen were noted after                        exposure level—generally referred to as
                                                Consistent with FFDCA section                        subchronic exposure. No treatment-                    a population-adjusted dose (PAD) or a
                                             408(b)(2)(D), and the factors specified in              related effects were noted in dogs after              reference dose (RfD)—and a safe margin
                                             FFDCA section 408(b)(2)(D), EPA has                     chronic exposure. There is no concern                 of exposure (MOE). For non-threshold
                                             reviewed the available scientific data                  for neurotoxicity or immunotoxicity                   risks, the Agency assumes that any
                                             and other relevant information in                       after exposure to ethaboxam. No                       amount of exposure will lead to some
                                             support of this action. EPA has                         evidence of increased quantitative or                 degree of risk. Thus, the Agency
                                             sufficient data to assess the hazards of                qualitative susceptibility was seen in                estimates risk in terms of the probability
                                             and to make a determination on                          the developmental toxicity studies in                 of an occurrence of the adverse effect
                                             aggregate exposure for ethaboxam                        rats and rabbits; however, increased                  expected in a lifetime. For more
                                             including exposure resulting from the                   qualitative susceptibility was seen in                information on the general principles
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                                             tolerances established by this action.                  the rat reproduction study where                      EPA uses in risk characterization and a
                                             EPA’s assessment of exposures and risks                 decreased body weight, decreased                      complete description of the risk
                                             associated with ethaboxam follows.                      viability, and delayed sexual maturation              assessment process, see http://
                                                                                                     were seen in offspring animals in the                 www.epa.gov/pesticides/factsheets/
                                             A. Toxicological Profile                                presence of limited parental effects                  riskassess.htm.
                                               EPA has evaluated the available                       (decreased body weight and body                          A summary of the toxicological
                                             toxicity data and considered its validity,              weight gain). Ethaboxam is classified as              endpoints for ethaboxam used for


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                                             36088             Federal Register / Vol. 82, No. 148 / Thursday, August 3, 2017 / Rules and Regulations

                                             human risk assessment is shown in the
                                             Table of this unit.

                                                  TABLE—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR ETHABOXAM FOR USE IN HUMAN HEALTH RISK
                                                                                          ASSESSMENT
                                                                                                                              RfD, PAD, LOC
                                                                                           Point of departure and un-
                                                       Exposure/scenario                                                          for risk                     Study and toxicological effects
                                                                                            certainty/safety factors           assessment

                                             Acute dietary (All Populations) .........   No appropriate endpoint attributable to a single dose identified.

                                             Chronic dietary (All populations) ......    NOAEL= 5.5 mg/kg/day .......       Chronic RfD =           Combined Chronic/Carcinogenicity-Rat.
                                                                                         UFA = 10x                            0.055 mg/kg/          LOAEL = 16.4 mg/kg/day based on effects observed
                                                                                         UFH = 10x                            day.                    in the male reproductive organs (testes,
                                                                                         FQPA SF = 1x                       cPAD = 0.055              epididymides, prostate, seminal vesicles).
                                                                                                                              mg/kg/day

                                             Cancer (Oral, dermal, inhalation) .....     Classification: ‘‘Suggestive Evidence of Carcinogenicity’’, based on an increased incidence of benign
                                                                                         Leydig Cell tumors in males. Cancer risk has been assessed using a non-linear approach.
                                               FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level of concern. mg/kg/day =
                                             milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-level. PAD = population adjusted dose (a = acute, c =
                                             chronic). RfD = reference dose. FQPA SF = Food Quality Protection Act safety factor. UF = uncertainty factor. UFA = extrapolation from animal
                                             to human (interspecies). UFH = potential variation in sensitivity among members of the human population (intraspecies).


                                             C. Exposure Assessment                                  estimates as discussed in Unit III.C.1.ii.,              Ethaboxam is not registered for any
                                                1. Dietary exposure from food and                    chronic exposure.                                     specific use patterns that would result
                                                                                                        iv. Anticipated residue and percent                in residential exposure.
                                             feed uses. In evaluating dietary
                                                                                                     crop treated (PCT) information. EPA did                  4. Cumulative effects from substances
                                             exposure to ethaboxam, EPA considered
                                                                                                     not use anticipated residue and/or PCT                with a common mechanism of toxicity.
                                             exposure under the petitioned-for
                                                                                                     information in the dietary assessment                 Section 408(b)(2)(D)(v) of FFDCA
                                             tolerances as well as all existing                      for ethaboxam. Tolerance-level residues               requires that, when considering whether
                                             ethaboxam tolerances in 40 CFR                          and/or 100% CT were assumed for all                   to establish, modify, or revoke a
                                             180.622. EPA assessed dietary                           food commodities.                                     tolerance, the Agency consider
                                             exposures from ethaboxam in food as                        2. Dietary exposure from drinking                  ‘‘available information’’ concerning the
                                             follows:                                                water. The Agency used screening level                cumulative effects of a particular
                                                i. Acute exposure. Quantitative acute                water exposure models in the dietary                  pesticide’s residues and ‘‘other
                                             dietary exposure and risk assessments                   exposure analysis and risk assessment                 substances that have a common
                                             are performed for a food-use pesticide,                 for ethaboxam in drinking water. These                mechanism of toxicity.’’
                                             if a toxicological study has indicated the              simulation models take into account                      EPA has not found ethaboxam to
                                             possibility of an effect of concern                     data on the physical, chemical, and fate/             share a common mechanism of toxicity
                                             occurring as a result of a 1-day or single              transport characteristics of ethaboxam.               with any other substances, and
                                             exposure.                                               Further information regarding EPA                     ethaboxam does not appear to produce
                                                No such effects were identified in the               drinking water models used in pesticide               a toxic metabolite produced by other
                                             toxicological studies for ethaboxam;                    exposure assessment can be found at                   substances. For the purposes of this
                                             therefore, a quantitative acute dietary                 http://www.epa.gov/oppefed1/models/                   tolerance action, therefore, EPA has
                                             exposure assessment is unnecessary.                     water/index.htm.                                      assumed that ethaboxam does not have
                                                ii. Chronic exposure. In conducting                     Based on the Pesticide in Water                    a common mechanism of toxicity with
                                             the chronic dietary exposure assessment                 Calculator (PWC) v1.50 and Pesticide                  other substances. For information
                                             EPA used the food consumption data                      Root Zone Model Ground Water (PRZM                    regarding EPA’s efforts to determine
                                             from the 2003–2008 U.S. Department of                   GW), the estimated drinking water                     which chemicals have a common
                                             Agriculture’s (USDA’s) National Health                  concentrations (EDWCs) of ethaboxam                   mechanism of toxicity and to evaluate
                                             and Nutrition Examination Survey,                       for chronic exposures for non-cancer                  the cumulative effects of such
                                             What We Eat in America (NHANES/                         assessments are estimated to be 3.91                  chemicals, see EPA’s Web site at http://
                                             WWEIA). Tolerance-level residues and                    ppb for surface water and 7.4 ppb for                 www.epa.gov/pesticides/cumulative.
                                             100% crop treated were assumed for all                  ground water.
                                             crops. Empirical data indicate that                        Modeled estimates of drinking water                D. Safety Factor for Infants and
                                             residues of ethaboxam in processed                      concentrations were directly entered                  Children
                                             grape (e.g., juice, raisins, etc.) and                  into the dietary exposure model. For                    1. In general. Section 408(b)(2)(C) of
                                             potato (e.g., flakes, chips, etc.)                      chronic dietary risk assessment, the                  FFDCA provides that EPA shall apply
                                             commodities are not expected to exceed                  water concentration of value 7.4 ppb                  an additional tenfold (10X) margin of
                                             the tolerance level for grapes or                       was used to assess the contribution to                safety for infants and children in the
                                             potatoes; therefore, no concentration                   drinking water.                                       case of threshold effects to account for
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                                             factors were used in this analysis.                        3. From non-dietary exposure. The                  prenatal and postnatal toxicity and the
                                                iii. Cancer. Based on the data                       term ‘‘residential exposure’’ is used in              completeness of the database on toxicity
                                             summarized in Unit III.A., EPA has                      this document to refer to non-                        and exposure unless EPA determines
                                             concluded that a nonlinear RfD                          occupational, non-dietary exposure                    based on reliable data that a different
                                             approach is appropriate for assessing                   (e.g., for lawn and garden pest control,              margin of safety will be safe for infants
                                             cancer risk to ethaboxam. Cancer risk                   indoor pest control, termiticides, and                and children. This additional margin of
                                             was assessed using the same exposure                    flea and tick control on pets).                       safety is commonly referred to as the


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                                                               Federal Register / Vol. 82, No. 148 / Thursday, August 3, 2017 / Rules and Regulations                                       36089

                                             FQPA Safety Factor (SF). In applying                    estimates to the acute PAD (aPAD) and                 IV. Other Considerations
                                             this provision, EPA either retains the                  chronic PAD (cPAD). For linear cancer
                                                                                                                                                           A. Analytical Enforcement Methodology
                                             default value of 10X, or uses a different               risks, EPA calculates the lifetime
                                             additional safety factor when reliable                  probability of acquiring cancer given the                Adequate enforcement methodology
                                             data available to EPA support the choice                estimated aggregate exposure. Short-,                 Liquid Chromotography with tandem
                                             of a different factor.                                  intermediate-, and chronic-term risks                 mass spectrometrometry (LC–MS/MS) is
                                                2. Prenatal and postnatal sensitivity.               are evaluated by comparing the                        available to enforce the tolerance
                                             There is evidence of increased                          estimated aggregate food, water, and                  expression.
                                             qualitative susceptibility in the rat                   residential exposure to the appropriate                  The method may be requested from:
                                             developmental and reproduction                          PODs to ensure that an adequate MOE                   Chief, Analytical Chemistry Branch,
                                             studies. Considering the overall toxicity               exists.                                               Environmental Science Center, 701
                                             profile and the doses and endpoints                        1. Acute risk. An acute aggregate risk             Mapes Rd., Ft. Meade, MD 20755–5350;
                                             selected for risk assessment for                        assessment takes into account acute                   telephone number: (410) 305–2905;
                                             ethaboxam, the degree of concern for                    exposure estimates from dietary                       email address: residuemethods@
                                             prenatal and postnatal effects observed                 consumption of food and drinking                      epa.gov.
                                             in the studies is low based on the                      water. No adverse effect resulting from               B. International Residue Limits
                                             following: The developmental/offspring                  a single oral exposure was identified
                                             effects observed in the studies are well                                                                         In making its tolerance decisions, EPA
                                                                                                     and no acute dietary endpoint was
                                             characterized and occur in the presence                                                                       seeks to harmonize U.S. tolerances with
                                                                                                     selected. Therefore, ethaboxam is not
                                             of maternal toxicity; a clear NOAEL has                                                                       international standards whenever
                                                                                                     expected to pose an acute risk.
                                             been identified in both of the studies;                                                                       possible, consistent with U.S. food
                                                                                                        2. Chronic risk. Using the exposure
                                             and there are no residual uncertainties                                                                       safety standards and agricultural
                                                                                                     assumptions described in this unit for
                                             for pre-and/or postnatal toxicity.                                                                            practices. EPA considers the
                                                                                                     chronic exposure, EPA has concluded
                                             Furthermore, the toxicology endpoint                                                                          international maximum residue limits
                                                                                                     that chronic exposure to ethaboxam
                                             established for risk assessment is based                                                                      (MRLs) established by the Codex
                                                                                                     from food and water will utilize 36% of
                                             on a lower NOAEL than the                                                                                     Alimentarius Commission (Codex), as
                                                                                                     the cPAD for children 1–2 years old the
                                             reproductive NOAEL, and thus is                                                                               required by FFDCA section 408(b)(4).
                                                                                                     population group receiving the greatest
                                             considered protective of developmental/                                                                       The Codex Alimentarius is a joint
                                                                                                     exposure. There are no residential uses
                                             offspring effects.                                                                                            United Nations Food and Agriculture
                                                                                                     for ethaboxam.
                                                3. Conclusion. EPA has determined                                                                          Organization/World Health
                                                                                                        3. Short-term and intermediate-term                Organization food standards program,
                                             that reliable data show the safety of                   risk. Short-term (and intermediate-term)
                                             infants and children would be                                                                                 and it is recognized as an international
                                                                                                     aggregate exposure takes into account                 food safety standards-setting
                                             adequately protected if the FQPA SF                     short-term (and intermediate-term)
                                             were reduced to 1x. That decision is                                                                          organization in trade agreements to
                                                                                                     residential exposure plus chronic                     which the United States is a party. EPA
                                             based on the following findings:                        exposure to food and water (considered
                                                i. The toxicity database for ethaboxam                                                                     may establish a tolerance that is
                                                                                                     to be a background exposure level).                   different from a Codex MRL; however,
                                             is complete.
                                                ii. There is no indication that                      Although short-term and intermediate-                 FFDCA section 408(b)(4) requires that
                                             ethaboxam is a neurotoxic chemical and                  term adverse effects were identified,                 EPA explain the reasons for departing
                                             there is no need for a developmental                    ethaboxam is not registered for any use               from the Codex level.
                                             neurotoxicity study or additional UFs to                patterns that would result in short-term                 MRLs have not been established by
                                             account for neurotoxicity.                              or intermediate-term residential                      Codex for residues of ethaboxam on the
                                                iii. Although there is evidence of                   exposure. Because there is no                         commodities in this action.
                                             increased qualitative susceptibility in                 residential exposure and chronic dietary
                                                                                                     exposure has already been assessed                    C. Revisions to Petitioned-For
                                             the rat reproduction study, the offspring
                                                                                                     under the appropriately protective                    Tolerances
                                             effects observed in the study are well
                                             characterized and clear NOAELs/                         cPAD (which is at least as protective as                 To reflect the correct commodity
                                             LOAELs have been identified in the                      the POD used to assess short-term or                  definitions, EPA revised the proposed
                                             study for the effects of concern.                       intermediate-term risk), no further                   commodity listings for Potato (Tuberous
                                             Additionally, the points of departure                   assessment of residential risk is                     and Corm Vegetable Subgroup 1C);
                                             (PODs) selected for risk assessment are                 necessary. EPA relies on the chronic                  Peppers (Pepper/Eggplant Crop
                                             protective of potential offspring effects.              dietary risk assessment for evaluating                Subgroup 8–10B); and Cucurbit
                                                iv. There are no residual uncertainties              short-term and intermediate-term risk                 Vegetables (Crop Group 9) to Vegetable,
                                             identified in the exposure databases.                   for ethaboxam.                                        tuberous and corm, subgroup 1C;
                                             The dietary food exposure assessments                      4. Aggregate cancer risk for U.S.                  Pepper/eggplant, subgroup 8–10B; and
                                             were performed based on 100% CT and                     population. As discussed in Unit III.A.,              Vegetable, cucurbit, group 9,
                                             tolerance-level residues. EPA made                      EPA has determined that the chronic                   respectively.
                                             conservative (protective) assumptions in                reference dose (cRfD) is protective of the               The petitioner requested that the
                                             the ground and surface water modeling                   potential cancer effects. Because chronic             tolerances for Pepper/eggplant,
                                             used to assess exposure to ethaboxam in                 exposure does not exceed the Agency’s                 subgroup 8–10B be set at 0.6 ppm and
                                             drinking water. These assessments will                  level of concern, EPA concludes that                  Ginseng be set at 0.09 ppm; however,
                                             not underestimate the exposure and                      ethaboxam does not pose a cancer risk.                the Agency is establishing the tolerances
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                                             risks posed by ethaboxam.                                  5. Determination of safety. Based on               at 0.90 ppm and 0.10 ppm, respectively,
                                                                                                     these risk assessments, EPA concludes                 based on Agency calculations using data
                                             E. Aggregate Risks and Determination of                 that there is a reasonable certainty that             obtained from the submitted residue
                                             Safety                                                  no harm will result to the general                    studies. The Agency used the
                                               EPA determines whether acute and                      population, or to infants and children                Organization of Economic Cooperation
                                             chronic dietary pesticide exposures are                 from aggregate exposure to ethaboxam                  and Development (OECD) maximum
                                             safe by comparing aggregate exposure                    residues.                                             residue limit (MRL) calculation


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                                             36090             Federal Register / Vol. 82, No. 148 / Thursday, August 3, 2017 / Rules and Regulations

                                             procedures to derive the recommended                    U.S.C. 3501 et seq.), nor does it require             Agricultural commodities, Pesticides
                                             levels. For crop groups, and per EPA’s                  any special considerations under                      and pests, Reporting and recordkeeping
                                             current policy, a tolerance level for each              Executive Order 12898, entitled                       requirements.
                                             representative commodity was                            ‘‘Federal Actions to Address                             Dated: June 29, 2017.
                                             calculated separately, and then the                     Environmental Justice in Minority                     Donna Davis,
                                             maximum value within each crop group                    Populations and Low-Income
                                                                                                                                                           Acting Director, Registration Division, Office
                                             was selected as the tolerance level.                    Populations’’ (59 FR 7629, February 16,
                                                                                                                                                           of Pesticide Programs.
                                                All of EPA’s tolerance levels are                    1994).
                                             expressed to provide sufficient                            Since tolerances and exemptions that                 Therefore, 40 CFR chapter I is
                                             precision for enforcement purposes.                     are established on the basis of a petition            amended as follows:
                                             This may include the addition of                        under FFDCA section 408(d), such as
                                             trailing zeros, as was the case for                     the tolerance in this final rule, do not              PART 180—[AMENDED]
                                             Vegetable, cucurbit, group 9 for which                  require the issuance of a proposed rule,              ■ 1. The authority citation for part 180
                                             a tolerance of 0.3 ppm was proposed                     the requirements of the Regulatory                    continues to read as follows:
                                             and a tolerance at 0.30 ppm is being                    Flexibility Act (RFA) (5 U.S.C. 601 et
                                             established.                                            seq.), do not apply.                                      Authority: 21 U.S.C. 321(q), 346a and 371.
                                                Finally, EPA is revising the tolerance                  This action directly regulates growers,            ■ 2. Section 180.622, paragraph (a) is
                                             expression to clarify (1) that, as                      food processors, food handlers, and food              revised to read as follows:
                                             provided in FFDCA section 408(a)(3),                    retailers, not States or tribes, nor does
                                             the tolerance covers metabolites and                    this action alter the relationships or                § 180.622 Ethaboxam; tolerances for
                                             degradates of ethaboxam not specifically                distribution of power and                             residues.
                                             mentioned; and (2) that compliance                      responsibilities established by Congress                 (a) General. Tolerances are
                                             with the specified tolerance levels is to               in the preemption provisions of FFDCA                 established for residues of ethaboxam,
                                             be determined by measuring only the                     section 408(n)(4). As such, the Agency                including its metabolites and
                                             specific compounds mentioned in the                     has determined that this action will not              degradates, in or on the commodities
                                             tolerance expression.                                   have a substantial direct effect on States            listed in the table below. Compliance
                                                                                                     or tribal governments, on the                         with the tolerance levels specified
                                             V. Conclusion                                                                                                 below is to be determined by measuring
                                                                                                     relationship between the national
                                               Therefore, tolerances are established                 government and the States or tribal                   only ethaboxam (N-(cyano-2-
                                             for residues of ethaboxam (N-(cyano-2-                  governments, or on the distribution of                thienylmethyl)-4-ethyl-2-(ethylamino)-
                                             thienylmethyl)-4-ethyl-2-(ethlyamino)-                  power and responsibilities among the                  5-thiazolecarboxamide) in or on the
                                             5-thiazolecarboxamide), including its                   various levels of government or between               commodity.
                                             metabolites and degradates, in or on                    the Federal Government and Indian
                                             Ginseng at 0.10 ppm; Pepper/eggplant,                   tribes. Thus, the Agency has determined                            Commodity                       Parts per
                                             subgroup 8–10B at 0.90 ppm; Vegetable,                                                                                                                      million
                                                                                                     that Executive Order 13132, entitled
                                             cucurbit, group 9 at 0.30 ppm; and                      ‘‘Federalism’’ (64 FR 43255, August 10,               Ginseng ................................            0.10
                                             Vegetable, tuberous and corm, subgroup                  1999) and Executive Order 13175,                      Grape 1 ..................................           6.0
                                             1C at 0.01 ppm. Compliance with the                     entitled ‘‘Consultation and Coordination              Pepper/eggplant subgroup
                                             tolerance levels specified above is to be               with Indian Tribal Governments’’ (65 FR                 8–10B ................................            0.90
                                             determined by measuring only                            67249, November 9, 2000) do not apply                 Vegetable, cucurbit, group 9                        0.30
                                             ethaboxam (N-(cyano-2-thienylmethyl)-                   to this action. In addition, this action              Vegetable, tuberous and
                                             4-ethyl-2-(ethlyamino)-5-                               does not impose any enforceable duty or                 corm, subgroup 1C ...........                     0.01
                                             thiazolecarboxamide).                                   contain any unfunded mandate as                           1 There
                                                                                                                                                                     is no U.S. registration as of Sep-
                                             VI. Statutory and Executive Order                       described under Title II of the Unfunded              tember 27, 2006.
                                             Reviews                                                 Mandates Reform Act (UMRA) (2 U.S.C.                  *        *        *        *        *
                                                                                                     1501 et seq.).                                        [FR Doc. 2017–16371 Filed 8–2–17; 8:45 am]
                                               This action establishes tolerances                       This action does not involve any
                                             under FFDCA section 408(d) in                           technical standards that would require
                                                                                                                                                           BILLING CODE 6560–50–P

                                             response to a petition submitted to the                 Agency consideration of voluntary
                                             Agency. The Office of Management and                    consensus standards pursuant to section
                                             Budget (OMB) has exempted these types                                                                         ENVIRONMENTAL PROTECTION
                                                                                                     12(d) of the National Technology                      AGENCY
                                             of actions from review under Executive                  Transfer and Advancement Act
                                             Order 12866, entitled ‘‘Regulatory                      (NTTAA) (15 U.S.C. 272 note).                         40 CFR Part 180
                                             Planning and Review’’ (58 FR 51735,
                                             October 4, 1993). Because this action                   VII. Congressional Review Act                         [EPA–HQ–OPP–2014–0679; FRL–9963–02]
                                             has been exempted from review under                       Pursuant to the Congressional Review
                                             Executive Order 12866, this action is                                                                         Cyclaniliprole; Pesticide Tolerances
                                                                                                     Act (5 U.S.C. 801 et seq.), EPA will
                                             not subject to Executive Order 13211,                                                                         and Exemption From the Requirement
                                                                                                     submit a report containing this rule and
                                             entitled ‘‘Actions Concerning                                                                                 of a Tolerance
                                                                                                     other required information to the U.S.
                                             Regulations That Significantly Affect                   Senate, the U.S. House of                             AGENCY:  Environmental Protection
                                             Energy Supply, Distribution, or Use’’ (66               Representatives, and the Comptroller                  Agency (EPA).
                                             FR 28355, May 22, 2001) or Executive                    General of the United States prior to                 ACTION: Final rule.
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                                             Order 13045, entitled ‘‘Protection of                   publication of the rule in the Federal
                                             Children from Environmental Health                      Register. This action is not a ‘‘major                SUMMARY:   This regulation establishes
                                             Risks and Safety Risks’’ (62 FR 19885,                  rule’’ as defined by 5 U.S.C. 804(2).                 tolerances for residues of cyclaniliprole
                                             April 23, 1997). This action does not                                                                         in or on multiple commodities that are
                                             contain any information collections                     List of Subjects in 40 CFR Part 180                   identified and discussed later in this
                                             subject to OMB approval under the                         Environmental protection,                           document. ISK Biosciences Corporation
                                             Paperwork Reduction Act (PRA) (44                       Administrative practice and procedure,                requested these tolerances under the


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Document Created: 2017-08-03 07:25:13
Document Modified: 2017-08-03 07:25:13
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 August 3, 2017. Objections and requests for hearings must be received on or before October 2, 2017, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ContactMike Goodis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone
FR Citation82 FR 36086 
CFR AssociatedEnvironmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements

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