[Federal Register Volume 82, Number 148 (Thursday, August 3, 2017)]
[Rules and Regulations]
[Pages 36086-36090]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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
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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