[Federal Register Volume 83, Number 121 (Friday, June 22, 2018)]
[Rules and Regulations]
[Pages 29033-29038]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-13454]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2017-0167; FRL-9977-94]


Benzovindiflupyr; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: In response to a petition filed by Syngenta Crop Protection, 
LLC under the Federal Food, Drug, and Cosmetic Act (FFDCA), this 
regulation establishes tolerances for residues of benzovindiflupyr in 
or on bluegrass, forage at 0.15 parts per million (ppm), bluegrass, hay 
at 7.0 ppm, bluegrass, straw at 6.0 ppm, bromegrass, forage at 0.15 
ppm, bromegrass, hay at 7.0 ppm, bromegrass, straw at 6.0 ppm, fescue, 
forage at 0.15 ppm, fescue, hay at 7.0 ppm, fescue, straw at 6.0 ppm, 
orchardgrass, forage at 0.15 ppm, orchardgrass, hay at 7.0 ppm, 
orchardgrass, straw at 6.0 ppm, and ryegrass, forage at 0.15 ppm, 
ryegrass, hay at 7.0 ppm, and ryegrass, straw at 6.0 ppm.

DATES: This regulation is effective June 22, 2018. Objections and 
requests for hearings must be received on or before August 21, 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-2017-0167, 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.,

[[Page 29034]]

Monday through Friday, excluding legal holidays. The telephone number 
for the Public Reading Room is (202) 566-1744, and the telephone number 
for the OPP Docket is (703) 305-5805. Please review the visitor 
instructions and additional information about the docket available at 
http://www.epa.gov/dockets.

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

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

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

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

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

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

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an 
objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2017-0167 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 
August 21, 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-2017-0167, 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 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 
6F8542) by Syngenta Crop Protection, LLC, P.O. Box 18300, Greensboro, 
NC 27419. 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 
grasses grown for seed, forage at .15 parts per million (ppm); grasses 
grown for seed, hay at 7 ppm; and grasses grown for seed, straw at 6 
ppm. That document referenced a summary of the petition prepared by 
Syngenta Crop Protection, LLC, the registrant, which is available in 
the docket, http://www.regulations.gov. Although one commenter 
requested that this petition be denied, no basis or information was 
provided to support a denial of this petition.

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 in rats. 
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

[[Page 29035]]

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 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 1000 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 Grasses Grown for Seeds 
on pages 30-36 in docket ID number EPA-HQ-OPP-2017-0167.

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 November 14, 2017 (82 FR 52669) 
(FRL-9967-33).

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 non-linear approach (i.e., RfD) adequately accounts 
for all chronic toxicity, including carcinogenicity, that could result 
from exposure to benzovindiflupyr. A separate cancer 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/or 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

[[Page 29036]]

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 
for non-cancer assessments 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 acute dietary risk 
assessment, the water concentration value of 8.41 ppb was used to 
assess the contribution to drinking water. For 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: The 
residential uses of benzovindiflupyr will result in short-term 
residential handler and post-application exposure in residential 
settings. 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.
    The residential scenarios for the benzovindiflupyr aggregate 
assessments are as follows: Adults: Inhalation exposures from treating 
ornamentals with a manually pressurized hand-wand 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 website at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

D. Safety Factor for Infants and Children

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

[[Page 29037]]

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 LOC for benzovindiflupyr is an MOE 
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. Based on the 
results of the chronic risk assessment, which accounts for all chronic 
toxicity, including carcinogenicity, 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 the specified grass 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 a MRL for benzovindiflupyr.

C. Revisions to Petitioned-For Tolerances

    The registrant petitioned for the use of benzovindiflupyr in or on 
grasses grown for seed, forage at 0.15 parts per million (ppm), grasses 
grown for seed, hay at 7 ppm and grasses grown for seed, straw at 6 
ppm. The Agency has not established a crop group for ``grasses grown 
for seed'' or otherwise defined what commodities are included in the 
category of ``grasses grown for seed''. The closest group tolerance to 
the commodity category requested is a crop group tolerance on grasses 
(i.e., ``grass, forage, fodder and hay, group 17''), although this 
group includes all grasses, whether grown for seed or not. Sufficient 
representative commodity residue data were not submitted to support 
establishing a crop group 17 tolerances; therefore, the Agency is 
establishing tolerances for the individual grasses for which residue 
data were submitted: Bluegrass, bromegrass, fescue, orchardgrass, and 
ryegrass.

V. Conclusion

    Therefore, tolerances are established for residues of 
benzovindiflupyr, including its metabolites and degradates, in or on 
bluegrass, forage at 0.15 ppm, bluegrass, hay at 7.0 ppm, bluegrass, 
straw at 6.0 ppm, bromegrass, forage at 0.15 ppm, bromegrass, hay at 
7.0 ppm, bromegrass, straw at 6.0 ppm, fescue, forage at 0.15 ppm, 
fescue, hay at 7.0 ppm, fescue, straw at 6.0 ppm, orchardgrass, forage 
at 0.15 ppm, orchardgrass, hay at 7.0 ppm, orchardgrass, straw at 6.0 
ppm, and ryegrass, forage at 0.15 ppm, ryegrass, hay at 7.0 ppm, and 
ryegrass, straw at 6.0 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); Executive Order 13045, entitled 
``Protection of Children from Environmental Health Risks and Safety 
Risks'' (62 FR 19885, April 23, 1997); or Executive Order 13771, 
entitled ``Reducing Regulations and Controlling Regulatory Costs'' (82 
FR 9339, February 3, 2017). This action does not contain any 
information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any 
special considerations

[[Page 29038]]

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 1, 2018.
Daniel J. Rosenblatt,
Deputy Director Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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


0
2. In Sec.  180.686, add alphabetically the commodities: ``Bluegrass, 
forage''; ``Bluegrass, hay''; ``Bluegrass, straw''; ``Bromegrass, 
forage''; ``Bromegrass, hay''; ``Bromegrass, straw''; ``Fescue, 
forage''; ``Fescue, hay''; ``Fescue, straw''; ``Orchardgrass, forage''; 
``Orchardgrass, hay''; ``Orchardgrass, straw''; ``Ryegrass, forage''; 
``Ryegrass, hay''; and ``Ryegrass, straw'' to the table in paragraph 
(a) to read as follows:


Sec.  180.686  Benzovindiflupyr; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Bluegrass, forage...........................................        0.15
Bluegrass, hay..............................................         7.0
Bluegrass, straw............................................         6.0
Bromegrass, forage..........................................        0.15
Bromegrass, hay.............................................         7.0
Bromegrass, straw...........................................         6.0
 
                                * * * * *
Fescue, forage..............................................        0.15
Fescue, hay.................................................         7.0
Fescue, straw...............................................         6.0
 
                                * * * * *
Orchardgrass, forage........................................        0.15
Orchardgrass, hay...........................................         7.0
Orchardgrass, straw.........................................         6.0
 
                                * * * * *
Ryegrass, forage............................................        0.15
Ryegrass, hay...............................................         7.0
Ryegrass, straw.............................................         6.0
 
                                * * * * *
------------------------------------------------------------------------

[FR Doc. 2018-13454 Filed 6-21-18; 8:45 am]
 BILLING CODE 6560-50-P


