83 FR 29033 - Benzovindiflupyr; Pesticide Tolerances

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 83, Issue 121 (June 22, 2018)

Page Range		29033-29038
FR Document		2018-13454

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.

Federal Register, Volume 83 Issue 121 (Friday, June 22, 2018)

[Federal Register Volume 83, Number 121 (Friday, June 22, 2018)]
[Rules and Regulations]
[Pages 29033-29038]
From the Federal Register Online [www.thefederalregister.org]
[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: RDFRNotices@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

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

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

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

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

Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-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:
residuemethods@epa.gov.

B. International Residue Limits

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

Federal Register / Vol. 83, No. 121 / Friday, June 22, 2018 / Rules and Regulations 29037

population group receiving the greatest chronic toxicity, including at 6 ppm. The Agency has not
exposure. carcinogenicity, EPA does not expect established a crop group for ‘‘grasses
2. Chronic risk. Using the exposure any cancer risk to the U.S. population grown for seed’’ or otherwise defined
assumptions described in this unit for from aggregate exposure to what commodities are included in the
chronic exposure, EPA has concluded benzovindiflupyr. category of ‘‘grasses grown for seed’’.
that chronic exposure to 6. Determination of safety. Based on The closest group tolerance to the
benzovindiflupyr from food and water these risk assessments, EPA concludes commodity category requested is a crop
will utilize 19% of the cPAD for that there is a reasonable certainty that group tolerance on grasses (i.e., ‘‘grass,
children 1–2 years old, the population no harm will result to the general forage, fodder and hay, group 17’’),
group receiving the greatest exposure. population, or to infants and children although this group includes all grasses,
Based on the explanation in Unit from aggregate exposure to whether grown for seed or not.
III.C.3., regarding residential use benzovindiflupyr residues. Sufficient representative commodity
patterns, chronic residential exposure to residue data were not submitted to
residues of benzovindiflupyr is not IV. Other Considerations support establishing a crop group 17
expected. A. Analytical Enforcement Methodology tolerances; therefore, the Agency is
3. Short-term risk. Short-term establishing tolerances for the
aggregate exposure takes into account An adequate analytical method is individual grasses for which residue
short-term residential exposure plus available to enforce the proposed data were submitted: Bluegrass,
chronic exposure to food and water tolerances for benzovindiflupyr in the bromegrass, fescue, orchardgrass, and
(considered to be a background specified grass commodities. A Quick, ryegrass.
exposure level). Benzovindiflupyr is Easy, Cheap, Effective, Rugged, and Safe
currently registered for uses that could (QuEChERS) multi-residue method V. Conclusion
result in short-term residential (EN15662:2009) was developed for the Therefore, tolerances are established
exposure, and the Agency has determination of residues of for residues of benzovindiflupyr,
determined that it is appropriate to benzovindiflupyr via liquid including its metabolites and
aggregate chronic exposure through food chromatography-mass spectrometry/ degradates, in or on bluegrass, forage at
and water with short-term residential mass spectrometry (LC–MS/MS) 0.15 ppm, bluegrass, hay at 7.0 ppm,
exposures to benzovindiflupyr. The method may be requested from: bluegrass, straw at 6.0 ppm, bromegrass,
Using the exposure assumptions Chief, Analytical Chemistry Branch, forage at 0.15 ppm, bromegrass, hay at
described in this unit for short-term Environmental Science Center, 701 7.0 ppm, bromegrass, straw at 6.0 ppm,
exposures, EPA has concluded the Mapes Rd., Ft. Meade, MD 20755–5350; fescue, forage at 0.15 ppm, fescue, hay
combined short-term food, water, and telephone number: (410) 305–2905; at 7.0 ppm, fescue, straw at 6.0 ppm,
residential exposures result in aggregate email address: residuemethods@ orchardgrass, forage at 0.15 ppm,
MOEs of 2100 for adults and 510 for epa.gov. orchardgrass, hay at 7.0 ppm,
children. Because EPA’s LOC for B. International Residue Limits orchardgrass, straw at 6.0 ppm, and
benzovindiflupyr is an MOE of 100 or ryegrass, forage at 0.15 ppm, ryegrass,
below, these MOEs are not of concern. In making its tolerance decisions, EPA hay at 7.0 ppm, and ryegrass, straw at
4. Intermediate-term risk. seeks to harmonize U.S. tolerances with 6.0 ppm.
Intermediate-term aggregate exposure international standards whenever
takes into account intermediate-term possible, consistent with U.S. food VI. Statutory and Executive Order
residential exposure plus chronic safety standards and agricultural Reviews
exposure to food and water (considered practices. EPA considers the This action establishes tolerances
to be a background exposure level). international maximum residue limits under FFDCA section 408(d) in
An intermediate-term adverse effect (MRLs) established by the Codex response to a petition submitted to the
was identified; however, Alimentarius Commission (Codex), as Agency. The Office of Management and
benzovindiflupyr is not registered for required by FFDCA section 408(b)(4). Budget (OMB) has exempted these types
any use patterns that would result in The Codex Alimentarius is a joint of actions from review under Executive
intermediate-term residential exposure. United Nations Food and Agriculture Order 12866, entitled ‘‘Regulatory
Intermediate-term risk is assessed based Organization/World Health Planning and Review’’ (58 FR 51735,
on intermediate-term residential Organization food standards program, October 4, 1993). Because this action
exposure plus chronic dietary exposure. and it is recognized as an international has been exempted from review under
Because there is no intermediate-term food safety standards-setting Executive Order 12866, this action is
residential exposure and chronic dietary organization in trade agreements to not subject to Executive Order 13211,
exposure has already been assessed which the United States is a party. EPA entitled ‘‘Actions Concerning
under the appropriately protective may establish a tolerance that is Regulations That Significantly Affect
cPAD (which is at least as protective as different from a Codex MRL; however, Energy Supply, Distribution, or Use’’ (66
the POD used to assess intermediate- FFDCA section 408(b)(4) requires that FR 28355, May 22, 2001); Executive
term risk), no further assessment of EPA explain the reasons for departing Order 13045, entitled ‘‘Protection of
intermediate-term risk is necessary, and from the Codex level. Children from Environmental Health
EPA relies on the chronic dietary risk The Codex has not established a MRL Risks and Safety Risks’’ (62 FR 19885,
assessment for evaluating intermediate- for benzovindiflupyr. April 23, 1997); or Executive Order
term risk for benzovindiflupyr. 13771, entitled ‘‘Reducing Regulations
5. Aggregate cancer risk for U.S. C. Revisions to Petitioned-For and Controlling Regulatory Costs’’ (82
daltland on DSKBBV9HB2PROD with RULES

population. Based on the discussion in Tolerances FR 9339, February 3, 2017). This action
Unit III.A., EPA considers the chronic The registrant petitioned for the use of does not contain any information
aggregate risk assessment to be benzovindiflupyr in or on grasses grown collections subject to OMB approval
protective of any aggregate cancer risk. for seed, forage at 0.15 parts per million under the Paperwork Reduction Act
Based on the results of the chronic risk (ppm), grasses grown for seed, hay at 7 (PRA) (44 U.S.C. 3501 et seq.), nor does
assessment, which accounts for all ppm and grasses grown for seed, straw it require any special considerations

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29038 Federal Register / Vol. 83, No. 121 / Friday, June 22, 2018 / Rules and Regulations

under Executive Order 12898, entitled and pests, Reporting and recordkeeping NATIONAL AERONAUTICS AND
‘‘Federal Actions to Address requirements. SPACE ADMINISTRATION
Environmental Justice in Minority Dated: June 1, 2018.
Populations and Low-Income 48 CFR Parts 1802
Populations’’ (59 FR 7629, February 16, Daniel J. Rosenblatt,
RIN 2700–AE46
1994). Deputy Director Registration Division, Office
Since tolerances and exemptions that of Pesticide Programs.
NASA Federal Acquisition Regulation
are established on the basis of a petition Supplement: Removal of Definitions
Therefore, 40 CFR chapter I is
under FFDCA section 408(d), such as (NFS Case 2018–N017)
amended as follows:
the tolerance in this final rule, do not
require the issuance of a proposed rule, AGENCY: National Aeronautics and
PART 180—[AMENDED] Space Administration.
the requirements of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et ACTION: Direct final rule.
■ 1. The authority citation for part 180
seq.), do not apply.
continues to read as follows: SUMMARY: NASA is issuing a final rule
This action directly regulates growers, to amend the NASA Federal Acquisition
food processors, food handlers, and food Authority: 21 U.S.C. 321(q), 346a and 371.
Regulation (FAR) Supplement (NFS) to
retailers, not States or tribes, nor does remove definitions which affect only the
this action alter the relationships or ■ 2. In § 180.686, add alphabetically the
commodities: ‘‘Bluegrass, forage’’; internal Agency administrative
distribution of power and procedures and have no cost or
responsibilities established by Congress ‘‘Bluegrass, hay’’; ‘‘Bluegrass, straw’’;
‘‘Bromegrass, forage’’; ‘‘Bromegrass, administrative impact on contractors or
in the preemption provisions of FFDCA prospective contractors.
section 408(n)(4). As such, the Agency hay’’; ‘‘Bromegrass, straw’’; ‘‘Fescue,
forage’’; ‘‘Fescue, hay’’; ‘‘Fescue, straw’’; DATES: This final rule is effective August
has determined that this action will not
have a substantial direct effect on States ‘‘Orchardgrass, forage’’; ‘‘Orchardgrass, 21, 2018. Comments due on or before
or tribal governments, on the hay’’; ‘‘Orchardgrass, straw’’; ‘‘Ryegrass, July 23, 2018. If adverse comments are
relationship between the national forage’’; ‘‘Ryegrass, hay’’; and ‘‘Ryegrass, received, NASA will publish a timely
government and the States or tribal straw’’ to the table in paragraph (a) to withdrawal of the rule in the Federal
governments, or on the distribution of read as follows: Register.
power and responsibilities among the ADDRESSES: Submit comments
various levels of government or between § 180.686 Benzovindiflupyr; tolerances for identified by NFS Case 2018–N017,
residues. using any of the following methods:
the Federal Government and Indian
tribes. Thus, the Agency has determined (a) * * * • Federal eRulemaking Portal: http://
that Executive Order 13132, entitled www.regulations.gov. Submit comments
‘‘Federalism’’ (64 FR 43255, August 10, Parts per via the Federal eRulemaking portal by
Commodity
1999) and Executive Order 13175, million searching for ‘‘NFS Case 2018–N017’’.
entitled ‘‘Consultation and Coordination Select the link ‘‘Comment Now’’ that
with Indian Tribal Governments’’ (65 FR corresponds with ‘‘NFS Case 2018–
67249, November 9, 2000) do not apply * * * * * N017’’. Follow the instructions
to this action. In addition, this action Bluegrass, forage ....................... 0.15 provided on the screen. Please include
does not impose any enforceable duty or Bluegrass, hay ............................ 7.0 your name, company name (if any), and
contain any unfunded mandate as Bluegrass, straw ......................... 6.0 ‘‘NFS Case 2018–N017’’ on any
Bromegrass, forage .................... 0.15 uploaded files.’’
described under Title II of the Unfunded
Mandates Reform Act (UMRA) (2 U.S.C. Bromegrass, hay ........................ 7.0 • Email: geoffrey.s.sage@nasa.gov.
Bromegrass, straw ...................... 6.0 Include ‘‘NFS Case 2018–N017’’ in the
1501 et seq.).
This action does not involve any subject line of the message.
* * * * *
technical standards that would require FOR FURTHER INFORMATION CONTACT:
Fescue, forage ............................ 0.15
Agency consideration of voluntary Geoffrey S. Sage, NASA Headquarters,
Fescue, hay ................................ 7.0
consensus standards pursuant to section Fescue, straw ............................. 6.0
Office of Procurement, Contract and
12(d) of the National Technology Grant Policy Division, Suite 5K32, 300
Transfer and Advancement Act * * * * *
E Street SW, Washington, DC 20456–
(NTTAA) (15 U.S.C. 272 note). Orchardgrass, forage .................. 0.15 0001. Telephone 202–358–2420.
Orchardgrass, hay ...................... 7.0 SUPPLEMENTARY INFORMATION:
VII. Congressional Review Act
Orchardgrass, straw ................... 6.0 I. Background
Pursuant to the Congressional Review
Act (5 U.S.C. 801 et seq.), EPA will * * * * * NFS part 1802, Definitions of Words
submit a report containing this rule and Ryegrass, forage ........................ 0.15 and Terms, contains the following
other required information to the U.S. Ryegrass, hay ............................. 7.0 definitions that affect only the internal
Senate, the U.S. House of Ryegrass, straw .......................... 6.0 Agency administrative procedures and
Representatives, and the Comptroller have no cost or administrative impact
General of the United States prior to * * * * * on contractors or prospective
publication of the rule in the Federal contractors: Administrator, Contracting
Register. This action is not a ‘‘major activity, Head of the agency or agency
daltland on DSKBBV9HB2PROD with RULES

[FR Doc. 2018–13454 Filed 6–21–18; 8:45 am]
rule’’ as defined by 5 U.S.C. 804(2). BILLING CODE 6560–50–P head, Head of the contracting activity
(HCA), NASA Acquisition internet
List of Subjects in 40 CFR Part 180
Service (NAIS), Procurement officer,
Environmental protection, and Senior Procurement Executive.
Administrative practice and procedure, Pursuant to Executive Order 13563,
Agricultural commodities, Pesticides Improving Regulation and Regulatory

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Document Created: 2018-11-06 09:51:05
Document Modified: 2018-11-06 09:51:05

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Rules and Regulations
Action		Final rule.
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).
Contact		Michael Goodis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; main telephone
FR Citation		83 FR 29033
CFR Associated		Environmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements