Document ID: EPA-HQ-OPP-2016-0448-0004
Agency: epa
Document Type: Rule
Title: Pesticide Tolerances: Benzovindiflupyr
Posted Date: 2017-11-14T05:00Z

[Federal Register Volume 82, Number 218 (Tuesday, November 14, 2017)]
[Rules and Regulations]
[Pages 52669-52674]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-24109]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2016-0448; FRL-9967-33]

Benzovindiflupyr; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
benzovindiflupyr in or on the bulb onion subgroup 3-07A, the green 
onion subgroup 3-07B, and increases an existing tolerance on sugarcane. 
Interregional Research Project Number 4 (IR-4) and Syngenta Crop 
Protection requested these tolerances under the Federal Food, Drug, and 
Cosmetic Act (FFDCA).

DATES: This regulation is effective November 14, 2017. Objections and 
requests for hearings must be received on or before January 16, 2018, 
and must be filed in accordance with the instructions provided in 40 
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2016-0448, 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: Michael Goodis, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone 
number: (703) 305-7090; email address: [email protected].

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

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

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

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

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

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an 
objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure

[[Page 52670]]

proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-
2016-0448 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 January 16, 2018. Addresses 
for mail and hand delivery of objections and hearing requests are 
provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing (excluding any Confidential Business Information (CBI)) for 
inclusion in the public docket. Information not marked confidential 
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without 
prior notice. Submit the non-CBI copy of your objection or hearing 
request, identified by docket ID number EPA-HQ-OPP-2016-0448, 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 October 18, 2016 (81 FR 71668) (FRL-
9952-19), 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 
6E8483) by IR-4, Rutgers, The State University of New Jersey, 500 
College Road East, Suite 201-W, Princeton, NJ 08540. The petition 
requested that 40 CFR 180.686 be amended by establishing tolerances for 
residues of the fungicide benzovindiflupyr (N-[9-(dichloromethylene)-
1,2,3,4-tetrahydro-1,4-methanonaphthalen-5-yl]-3-(difluoromethyl)-1-
methyl-1H-pyrazole-4-carboxamide) in or on onion, bulb, subgroup 3-07A 
at 0.02 parts per million (ppm), and onion, green, subgroup 3-07B at 
0.4 ppm.
    In the Federal Register of July 26, 2017 (82 FR 34664) (FRL-9963-
50), 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 
6F8499) by Syngenta Crop Protection, LLC, P.O. Box 18300, Greensboro, 
NC 27419. The petition requested to establish a tolerance in 40 CFR 
part 180 for residues of the fungicide benzovindiflupyr in or on 
Sugarcane, cane, at 0.3 ppm.
    The documents referenced summaries of the petitions prepared by 
Syngenta Crop Protection, LLC, the registrant, which are available in 
the dockets EPA-HQ-OPP-2016-0448 and EPA-HQ-OPP-2016-0752 at http://www.regulations.gov. There were no comments received in response to 
either notice of filing.

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 benzovindiflupyr including 
exposure resulting from the tolerances established by this action. 
EPA's assessment of exposures and risks associated with 
benzovindiflupyr 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 rat is the most sensitive species tested, and the target organs 
of benzovindiflupyr are the liver, thyroid, and kidneys. Hepatotoxicity 
was manifested as changes in liver weights, liver hypertrophy, and 
decreased triglycerides. The kidney effects were tubular cell pigment 
deposits, changes in the tubular basophilia, and increased urea. 
Enlargement and focal c-cell hyperplasia of the thyroid were observed. 
An increased incidence of cell hypertrophy in the pituitary pars 
distalis was noted in the F1 generation males and females in the 2-
generation reproductive toxicity rat study. Mouse studies revealed 
distended large intestines, soft feces and hyperplasia of the colon and 
caecum. Indications of general malaise including decreased body weight 
and food consumption, decreased activity, decreased grip strength, 
piloerection, decreased response to stimulus, hunched posture, gait 
changes and/or ataxia were reported in the rat and mouse studies. In 
several studies, females tended to be more sensitive than males and 
effects were generally seen at lower doses with gavage dosing than with 
dietary dosing.
    There are no concerns for developmental or reproductive toxicity 
following benzovindiflupyr exposure. Decreased fetal weight and 
ossification in the rat developmental toxicity studies occurred at 
maternally toxic doses. There were no maternal or fetal adverse effects 
in the rabbit developmental study. In rat reproduction studies, 
offspring effects (decreased body weight, liver and pituitary effects) 
occurred at doses higher than those causing parental effects; thus, 
there was no quantitative increase in sensitivity in rat pups. There 
were no single-dose developmental effects identified in the 
developmental toxicity studies in rats or rabbits. Although decreases 
in growing follicle counts were noted in the 2-generation reproduction 
toxicity study, this effect did not result in reduced fertility in the 
rat. Furthermore, the antral follicle counts at a later stage in 
development were not decreased, so the decreased growing follicle count 
effect is not considered adverse.
    No evidence of specific neurotoxicity was observed in the acute 
oral (gavage) and sub-chronic oral (dietary) neurotoxicity (ACN and 
SCN) studies in rats, conducted on the benzovindiflupyr technical 
product. Although

[[Page 52671]]

benzovindiflupyr caused decreased activity and decreased grip strength 
in the neurotoxicity studies, there was no supportive neuro-
histopathology in any study to indicate a specific neurotoxic effect.
    The mouse immunotoxicity study was negative by the T-cell Dependent 
Antigen Response (TDAR) assay in the mouse.
    No systemic effects were noted at the limit dose of 1,000 
milligrams/kilogram/day (mg/kg/day) in the 28-day dermal rat study.
    The Agency classified benzovindiflupyr as showing ``Suggestive 
Evidence of Carcinogenic Potential'' based on the presence of granular 
cell tumors of the brain in male rats only at the highest dose tested. 
The Agency concluded that a non-genotoxic mode of action for thyroid 
tumors observed in male rats has been established as a result of 
upregulation of uridine diphosphate glucuronyltransferase (UDPGT), 
increased clearance of T3 and T4 hormones, and increased TSH levels, 
resulting in increased thyroid cell proliferation, which progress to 
form thyroid tumors. There was no evidence of carcinogenicity in female 
rats or in male or female mice. In addition, there is no concern for 
mutagenicity. The Agency has determined that using a non-linear 
approach (i.e., RfD; reference dose) will adequately account for all 
chronic toxicity, including carcinogenicity, that could result from 
exposure to benzovindiflupyr.
    Specific information on the studies received and the nature of the 
adverse effects caused by benzovindiflupyr 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 the document titled ``Benzovindiflupyr. Human 
Health Risk Assessment for the Proposed Use on Onion, Bulb Subgroup 3-
07A; Onion, Green, Subgroup 3-07B; and Sugarcane'' on pages 32-38 in 
docket ID number EPA-HQ-OPP-2016-0448.

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://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
    A summary of the toxicological endpoints for benzovindiflupyr used 
for human risk assessment is discussed in Unit III.B. of the final rule 
published in the Federal Register of October 2, 2015 (80 FR 59627) 
(FRL-9933-03).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to benzovindiflupyr, EPA considered exposure under the 
petitioned-for tolerances as well as all existing benzovindiflupyr 
tolerances in 40 CFR 180.686. EPA assessed dietary exposures from 
benzovindiflupyr 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.
    Such effects were identified for benzovindiflupyr. In estimating 
acute dietary exposure, EPA used 2003-2008 food consumption information 
from the U.S. Department of Agriculture's (USDA's) National Health and 
Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA). 
As to residue levels in food, EPA assumed 100 percent crop treated 
(PCT) and tolerance-level residues.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used 2003-2008 food consumption data from the USDA's 
NHANES/WWEIA. As to residue levels in food, EPA assumed 100 PCT and 
tolerance-level residues.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that a nonlinear RfD approach adequately accounts for all 
chronic toxicity, including carcinogenicity, that could result from 
exposure to benzovindiflupyr; therefore, a separate dietary cancer risk 
assessment was not performed.
    iv. Anticipated residue and PCT information. EPA did not use 
anticipated residue or PCT information in the dietary assessment for 
benzovindiflupyr. Tolerance-level residues and 100 PCT 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 benzovindiflupyr in drinking water. These simulation 
models take into account data on the physical, chemical, and fate/
transport characteristics of benzovindiflupyr. Further information 
regarding EPA drinking water models used in pesticide exposure 
assessment can be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
    Based on the Surface Water Concentration Calculator (SWCC) model 
and the Pesticide Root Zone Model Ground Water (PRZM-GW) model, the 
estimated drinking water concentrations (EDWCs) of benzovindiflupyr for 
acute exposures are estimated to be 8.41 parts per billion (ppb) for 
surface water and 0.14 ppb for ground water and for chronic exposures 
are estimated to be 5.41 ppb for surface water and 0.14 ppb for ground 
water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For the acute dietary risk 
assessment, the water concentration value of 8.41 ppb was used to 
assess the contribution to drinking water. For the chronic dietary risk 
assessment, the water concentration of value 5.41 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).
    Benzovindiflupyr is currently registered for the following uses 
that could result in residential exposures: Turf and ornamentals. EPA 
assessed residential exposure using the following assumptions: For 
handlers, exposure is expected as a result of application to turf and 
ornamentals. Post-application exposure is also expected as a result of 
being in an environment that has been previously treated with 
benzovindiflupyr. Both handler and

[[Page 52672]]

post-application exposure is short-term in duration; there are no 
intermediate- or long term-exposures expected from the residential uses 
of benzovindiflupyr. Only residential handler inhalation and post-
application incidental oral exposure scenarios have been quantitatively 
assessed since no dermal hazard was identified. Residential handler 
short-term inhalation MOEs are well above the LOC of 100 for all 
scenarios assessed and are not of concern (inhalation MOEs are 
>=180,000). Residential post-application (incidental oral) MOEs for 
children ranged from 8,000 to 3,600,000 on the day of application, 
using default input values, and are not of concern (LOC = 100).
    The residential scenarios used for the benzovindiflupyr aggregate 
assessments were as follows: Adults: Inhalation exposures from treating 
ornamentals with a manually pressurized handwand or backpack sprayer; 
Children 1 to <2 years old: Post-application hand-to-mouth exposures 
from treated turf. These scenarios resulted in the highest residential 
exposures and are considered protective of other exposure scenarios.
    Further information regarding EPA standard assumptions and generic 
inputs for residential exposures may be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    EPA has not found benzovindiflupyr to share a common mechanism of 
toxicity with any other substances, and benzovindiflupyr does not 
appear to produce a toxic metabolite produced by other substances. For 
the purposes of this tolerance action, therefore, EPA has assumed that 
benzovindiflupyr 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://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the 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 was no evidence of 
quantitative or qualitative susceptibility in fetuses or offspring in 
the rat and rabbit developmental studies or in the 2-generation rat 
reproduction study. Benzovindiflupyr produced effects in rat fetuses 
(i.e., decreased fetal weight and ossification) in developmental 
toxicity studies at maternally toxic doses. In the rabbit developmental 
study, there were no adverse effects in either the does or the fetuses 
at the highest dose tested. In reproduction studies, offspring effects 
occurred at doses higher than the doses causing parental effects; thus, 
there was no quantitative increase in sensitivity in rat pups. The 
LOAELs and NOAELs for the rat developmental and rat reproduction 
studies were clearly defined.
    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 benzovindiflupyr is complete.
    ii. There is no indication that benzovindiflupyr is a neurotoxic 
chemical and there is no need for a developmental neurotoxicity study 
or additional UFs to account for neurotoxicity.
    iii. There is no evidence that benzovindiflupyr results in 
increased susceptibility in in utero rats or rabbits in the prenatal 
developmental studies or in young rats in the 2-generation reproduction 
study.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on 100 PCT and tolerance-level residues. EPA made conservative 
(protective) assumptions in the ground and surface water modeling used 
to assess exposure to benzovindiflupyr in drinking water. EPA used 
similarly conservative assumptions to assess post-application exposure 
of children as well as incidental oral exposure of toddlers. These 
assessments will not underestimate the exposure and risks posed by 
benzovindiflupyr.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide 
exposures are safe by comparing aggregate exposure estimates to the 
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA 
calculates the lifetime probability of acquiring cancer given the 
estimated aggregate exposure. Short-, intermediate-, and chronic-term 
risks are evaluated by comparing the estimated aggregate food, water, 
and residential exposure to the appropriate PODs to ensure that an 
adequate MOE exists.
    1. Acute risk. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food and water 
to benzovindiflupyr will occupy 43% of the aPAD for children 1-2 years 
old, the population group receiving the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
benzovindiflupyr from food and water will utilize 19% of the cPAD for 
children 1-2 years old, the population group receiving the greatest 
exposure. Based on the explanation in Unit III.C.3., regarding 
residential use patterns, chronic residential exposure to residues of 
benzovindiflupyr is not expected.
    3. Short-term risk. Short-term aggregate exposure takes into 
account short-term residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level).
    Benzovindiflupyr is currently registered for uses that could result 
in short-term residential exposure, and the Agency has determined that 
it is appropriate to aggregate chronic exposure through food and water 
with short-term residential exposures to benzovindiflupyr.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water, 
and residential exposures result in aggregate MOEs of 2100 for adults 
and 510 for children. Because EPA's level of concern for 
benzovindiflupyr is a MOE

[[Page 52673]]

of 100 or below, these MOEs are not of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level).
    An intermediate-term adverse effect was identified; however, 
benzovindiflupyr is not registered for any use patterns that would 
result in intermediate-term residential exposure. Intermediate-term 
risk is assessed based on intermediate-term residential exposure plus 
chronic dietary exposure. Because there is no intermediate-term 
residential exposure and chronic dietary exposure has already been 
assessed under the appropriately protective cPAD (which is at least as 
protective as the POD used to assess intermediate-term risk), no 
further assessment of intermediate-term risk is necessary, and EPA 
relies on the chronic dietary risk assessment for evaluating 
intermediate-term risk for benzovindiflupyr.
    5. Aggregate cancer risk for U.S. population. Based on the 
discussion in Unit III.A., EPA considers the chronic aggregate risk 
assessment to be protective of any aggregate cancer risk. As there is 
no chronic risk of concern, EPA does not expect any cancer risk to the 
U.S. population from aggregate exposure to benzovindiflupyr.
    6. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, or to infants and children from aggregate 
exposure to benzovindiflupyr residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    An adequate analytical method is available to enforce the proposed 
tolerances for benzovindiflupyr in plant and livestock commodities. A 
Quick, Easy, Cheap, Effective, Rugged, and Safe (QuEChERS) multi-
residue method (EN15662:2009) was developed for the determination of 
residues of benzovindiflupyr via liquid chromatography-mass 
spectrometry/mass spectrometry (LC-MS/MS).
    The method may be requested from: Chief, Analytical Chemistry 
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 
20755-5350; telephone number: (410) 305-2905; email address: 
[email protected].

B. International Residue Limits

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

V. Conclusion

    Therefore, tolerances are established for residues of 
benzovindiflupyr, including its metabolites and degradates, in or on 
onion, bulb, subgroup 3-07A at 0.02 ppm; onion, green, subgroup 3-07B 
at 0.40 ppm; and the existing ``sugarcane, cane'' tolerance is 
increased from 0.04 ppm to 0.30 ppm.

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: October 12, 2017.
Michael L. Goodis,
Director Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

[[Page 52674]]

PART 180--[AMENDED]

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

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

0
2. In Sec.  180.686, amend the table in paragraph (a) by:
0
i. Adding alphabetically the commodities ``Onion, bulb, subgroup 3-
07A'', ``Onion, green, subgroup 3-07B'', and
0
ii. Revising the commodity ``Sugarcane, cane''.
    The additions and revisions read as follows:

Sec.  180.686  Benzovindiflupyr; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Onion, bulb, subgroup 3-07A..................................       0.02
Onion, green, subgroup 3-07B.................................       0.40
 
                                * * * * *
Sugarcane, cane..............................................       0.30
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2017-24109 Filed 11-13-17; 8:45 am]
 BILLING CODE 6560-50-P