83 FR 8006 - Quizalofop ethyl; Pesticide Tolerances

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 83, Issue 37 (February 23, 2018)

Page Range		8006-8011
FR Document		2018-03760

This regulation establishes tolerances for residues of quizalofop ethyl in or on the commodities wheat germ and milled byproducts, and increases the tolerances in or on wheat forage, hay, and straw. Albaugh, LLC requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

Federal Register, Volume 83 Issue 37 (Friday, February 23, 2018)

[Federal Register Volume 83, Number 37 (Friday, February 23, 2018)]
[Rules and Regulations]
[Pages 8006-8011]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2018-03760]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2016-0360; FRL-9972-30]

Quizalofop ethyl; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
quizalofop ethyl in or on the commodities wheat germ and milled
byproducts, and increases the tolerances in or on wheat forage, hay,
and straw. Albaugh, LLC requested these tolerances under the Federal
Food, Drug, and Cosmetic Act (FFDCA).

[[Page 8007]]

DATES: This regulation is effective February 23, 2018. Objections and
requests for hearings must be received on or before April 24, 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-2016-0360, 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: 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. To access the OCSPP
test guidelines referenced in this document electronically, please go
to http://www.epa.gov/test-guidelines-pesticides-and-toxic-substances.

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-2016-0360 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
April 24, 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-2016-0360, 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/where-send-comments-epa-dockets.
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 Tolerances

In the Federal Register of December 20, 2016 (81 FR 92758) (FRL-
9956-04), 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
6F8476) by Albaugh, LLC, P.O. Box 2127, Valdosta, GA 31604. The
petition requested that 40 CFR part 180.441 be amended by establishing
tolerances for residues of the herbicide quizalofop ethyl, in or on
wheat, bran at 0.40 parts per million (ppm); wheat, forage at 2.0 ppm;
wheat, germ at 0.40 ppm; wheat, hay at 2.0 ppm; wheat, milled
byproducts at 0.40 ppm; and wheat, straw at 0.80 ppm. That document
referenced a summary of the petition prepared by Albaugh, LLC, the
registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the
notice of filing.
EPA determined that a separate tolerance is not needed for wheat
bran. The reason for this change is explained in Unit IV.C.

III. Aggregate Risk Assessment and Determination of Safety

Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
.''
Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for quizalofop ethyl, including
exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with quizalofop
ethyl follows.

A. Toxicological Profile

EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as

[[Page 8008]]

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.
Quizalofop ethyl is a 50/50 racemic mixture of R- and S-
enantiomers. Quizalofop-P-ethyl, the purified R-enantiomer, is the
pesticidally-active isomer. Since the toxicological profiles of
quizalofop ethyl and quizalofop-P-ethyl are similar, the available
toxicity studies are adequate to support both compounds. For the
purposes of this final rule, both quizalofop ethyl and quizalofop-P-
ethyl are collectively referred to as ``quizalofop ethyl.''
Quizalofop ethyl has very low acute toxicity via the oral, dermal,
and inhalation routes of exposure, is not an eye or skin irritant, and
is not a skin sensitizer. There were no adverse effects observed in the
oral toxicity studies that could be attributable to a single-dose
exposure.
Repeated-dose toxicity studies indicate the liver as the target
organ, as evidenced by increased liver weights and histopathological
changes. Following oral administration, quizalofop ethyl is rapidly
excreted via urine and feces. In the subchronic oral toxicity rat
study, effects of decreased body weight gains, increased liver weight,
and centrilobular liver cell enlargement were observed. In the
subchronic oral toxicity dog study, an increased incidence of
testicular atrophy was observed. In the combined chronic toxicity/
carcinogenicity study in rats, an increased incidence of centrilobular
liver cell enlargement was observed in both sexes and mild anemia in
males.
No dermal toxicity effects were observed in the subchronic dermal
toxicity rabbit study at up to the limit dose. Subchronic inhalation
toxicity is assumed to be equivalent to oral toxicity. In the chronic
oral toxicity dog study, no toxicity effects were observed at the
highest dose tested.
In the rat and rabbit developmental toxicity studies, maternal
effects including decreased body weight gains and food consumption were
observed; no developmental effects were observed up to the highest dose
tested. In the 2-generation reproduction toxicity study in rats,
maternal effects including decreased body weight and decreased body
weight gains were observed at the same dose level that resulted in
prenatal and postnatal effects (decreased percentage of pups born alive
and decreased pup weights); no evidence of adverse effects on the
functional development of pups was observed.
Although tumors were observed in male and female mice after
exposure to quizalofop ethyl, the overall evidence for carcinogenicity
is weak, as discussed in supporting documents. Additionally, the point
of departure used for establishing the chronic reference dose for
quizalofop ethyl is significantly lower (30X) than the dose that
induced tumors in male and female mice. EPA has determined that
quantification of cancer risk using a non-linear approach would
adequately account for all chronic toxicity, including carcinogenicity,
which could result from exposure to quizalofop ethyl.
Based on the results of acceptable toxicity studies, quizalofop
ethyl does not show evidence of neurotoxicity or neuropathology.
Quizalofop ethyl showed no evidence of immunotoxicity.
Specific information on the studies received and the nature of the
adverse effects caused by quizalofop ethyl as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document Quizalofop-P-ethyl. Human Health Risk
assessment in Support of the Proposed New Use on Rice in docket ID
number EPA-HQ-OPP-2015-0412.

B. Toxicological Points of Departure/Levels of Concern

Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see http://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
A summary of the toxicological endpoints for quizalofop ethyl used
for human risk assessment is discussed in Unit II.B. of the final rule
published in the Federal Register of December 1, 2016 (81 FR 86581)
(FRL-9950-89).

C. Exposure Assessment

1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to quizalofop ethyl, EPA considered exposure under the
petitioned-for tolerances as well as all existing quizalofop ethyl
tolerances in 40 CFR 180.441. EPA assessed dietary exposures from
quizalofop ethyl in food as follows:
i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure. No such effects were
identified in the toxicological studies for quizalofop ethyl;
therefore, a quantitative acute dietary exposure assessment is
unnecessary.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment, EPA used the food consumption data from the USDA 2003-2008
National Health and Nutrition Examination Survey, What We Eat in
America (NHANES/WWEIA). As to residue levels in food, EPA incorporated
tolerance-level residues, average percent crop treated (PCT)
information, and default processing factors for all processed
commodities except sunflower oil, where an empirical factor was used.
iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that the chronic reference dose will be protective of any
potential carcinogenicity; therefore, a separate dietary exposure
assessment for the purpose of assessing cancer risk is unnecessary.
iv. Anticipated residues and percent crop treated (PCT)
information. EPA did not use anticipated residue information to assess
exposure for these tolerances; rather, EPA used tolerance-level
residues in its exposure assessment.
Section 408(b)(2)(F) of FFDCA states that the Agency may use data
on the actual percent of food treated for assessing chronic dietary
risk only if:
Condition a: The data used are reliable and provide a
valid basis to show what percentage of the food

[[Page 8009]]

derived from such crop is likely to contain the pesticide residue.
Condition b: The exposure estimate does not underestimate
exposure for any significant subpopulation group.
Condition c: Data are available on pesticide use and food
consumption in a particular area, the exposure estimate does not
understate exposure for the population in such area.
In addition, the Agency must provide for periodic evaluation of any
estimates used. To provide for the periodic evaluation of the estimate
of PCT as required by FFDCA section 408(b)(2)(F), EPA may require
registrants to submit data on PCT.
The Agency estimated the average PCT for existing uses as follows:
Barley: 1%; beans, green: 2.5%; canola: 5%; cotton: 1%; dry beans/peas:
15%; peas, green: 2.5%; soybeans: 2.5%; sugar beets: 2.5%; and
sunflowers: 5%. For all other existing uses, including the amended use
on wheat, 100% of the crop treated was assumed.
In most cases, EPA uses available data from United States
Department of Agriculture/National Agricultural Statistics Service
(USDA/NASS), proprietary market surveys, and the National Pesticide Use
Database for the chemical/crop combination for the most recent 6 to 7
years. EPA uses an average PCT for chronic dietary risk analysis. The
average PCT value for each existing use is derived by combining
available public and private market survey data for that use, averaging
across all observations, and is rounded to the nearest multiple of 5%
for use in the analysis; unless the average PCT value is estimated at
less than 2.5% or 1%, in which case the Agency uses 2.5% or 1%,
respectively, as the average PCT value in the analysis.
The Agency believes that the three conditions discussed in Unit
III.C.1.iv. have been met. With respect to Condition a, PCT estimates
are derived from Federal and private market survey data, which are
reliable and have a valid basis. The Agency is reasonably certain that
the percentage of the food treated is not likely to be an
underestimation. As to Conditions b and c, regional consumption
information and consumption information for significant subpopulations
is taken into account through EPA's computer-based model for evaluating
the exposure of significant subpopulations including several regional
groups. Use of this consumption information in EPA's risk assessment
process ensures that EPA's exposure estimate does not understate
exposure for any significant subpopulation group and allows the Agency
to be reasonably certain that no regional population is exposed to
residue levels higher than those estimated by the Agency. Other than
the data available through national food consumption surveys, EPA does
not have available reliable information on the regional consumption of
food to which quizalofop ethyl may be applied in a particular area.
2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for quizalofop ethyl in drinking water. These simulation
models take into account data on the physical, chemical, and fate/
transport characteristics of quizalofop ethyl. Further information
regarding EPA drinking water models used in pesticide exposure
assessment can be found at http://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
Based on the Modified Tier 1 Rice Model and Pesticide Root Zone
Model Ground Water (PRZM GW), the estimated drinking water
concentrations (EDWCs) of quizalofop ethyl for chronic exposures for
non-cancer assessments are estimated to be 125 parts per billion (ppb)
for surface water and 89 ppb for ground water.
Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For chronic dietary risk
assessment, the water concentration value of 125 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). Quizalofop ethyl is
not registered for any specific use patterns that would result in
residential exposure.
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
EPA has not found quizalofop ethyl to share a common mechanism of
toxicity with any other substances, and quizalofop ethyl does not
appear to produce a toxic metabolite produced by other substances. For
the purposes of this tolerance action, therefore, EPA has assumed that
quizalofop ethyl 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://www.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. As summarized in Unit
III.A., results from the rat and rabbit developmental toxicity and the
2-generation rat reproduction toxicity studies indicated no qualitative
or quantitative evidence of increased susceptibility in developing
fetuses or in the offspring following prenatal and/or postnatal
exposure to quizalofop ethyl.
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 quizalofop ethyl is complete.
ii. There is no indication that quizalofop ethyl 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 qualitative or quantitative evidence that
quizalofop ethyl 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 tolerance-level residues, average PCTs for certain existing uses,
and 100 PCT for other existing uses including the amended wheat use.
EPA made conservative

[[Page 8010]]

(protective) assumptions in the ground and surface water modeling used
to assess exposure to quizalofop ethyl in drinking water. These
assessments will not underestimate the exposure and risks posed by
quizalofop ethyl.

E. Aggregate Risks and Determination of Safety

EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
1. Acute risk. An acute aggregate risk assessment takes into
account acute exposure estimates from dietary consumption of food and
drinking water. No adverse effect resulting from a single-dose oral
exposure was identified and no acute dietary endpoint was selected.
Therefore, quizalofop ethyl is not expected to pose an acute risk.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
quizalofop ethyl from food and water will utilize 84% of the cPAD for
all infants less than 1-year old, the population group receiving the
greatest exposure. Most of the dietary exposure is attributed to
drinking water, utilizing 75% of the cPAD for all infants less than 1-
year old. There are no residential uses for quizalofop ethyl.
3. Short- and intermediate-term risk. Short- and intermediate-term
aggregate exposure takes into account short- and intermediate-term
residential exposure plus chronic exposure to food and water
(considered to be a background exposure level). Because there are no
residential uses, quizalofop ethyl is not expected to pose short- or
intermediate-term risk.
4. Aggregate cancer risk for U.S. population. As discussed in Unit
III.A., EPA has concluded that regulating on the chronic reference dose
will be protective of potential carcinogenicity. Based on the results
of the chronic risk assessment, EPA concludes that quizalofop ethyl is
not expected to pose a cancer risk to humans.
5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to quizalofop ethyl residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

An adequate enforcement methodology (Morse Meth-147, a liquid
chromatography method using tandem mass spectrometry detection (LC-MS/
MS) for plant commodities including wheat) is available to enforce the
tolerance expression.
The method may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD
20755-5350; telephone number: (410) 305-2905; email address:
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 quizalofop ethyl.

C. Revisions to Petitioned-For Tolerances

EPA determined that a separate tolerance is not needed for wheat
bran, since it is included in the commodity definition for wheat,
milled byproducts, which includes wheat bran, middlings, and shorts.

V. Conclusion

Therefore, tolerances are established for residues of quizalofop
ethyl in or on wheat, germ at 0.40 ppm and wheat, milled byproducts at
0.40 ppm. Existing tolerances are increased for residues of quizalofop
ethyl in or on wheat, forage from 0.05 to 2.0 ppm; wheat, hay from 0.05
to 2.0 ppm; and wheat, straw from 0.05 to 0.80 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 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

[[Page 8011]]

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: February 9, 2018.
Michael Goodis,
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. 180.441,
0
a. Add alphabetically the entries ``Wheat, germ'' and ``Wheat, milled
byproducts'' to the table in paragraph (a)(1).
b. Revise the entries ``Wheat, forage''; ``Wheat, hay''; and
``Wheat, straw'' in the table in paragraph (a)(1).
The additions and revisions read as follows:

Sec. 180.441 Quizalofop ethyl; tolerances for residues.

(a) * * *
(1) * * *

------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------

* * * * *
Wheat, forage............................................... 2.0
Wheat, germ................................................. 0.40

* * * * *
Wheat, hay.................................................. 2.0
Wheat, milled byproducts.................................... 0.40
Wheat, straw................................................ 0.80
------------------------------------------------------------------------

* * * * *
[FR Doc. 2018-03760 Filed 2-22-18; 8:45 am]
BILLING CODE 6560-50-P

8006 Federal Register / Vol. 83, No. 37 / Friday, February 23, 2018 / Rules and Regulations

22, 2001); Executive Order 13045, has determined that this action will not Senate, the U.S. House of
entitled ‘‘Protection of Children from have a substantial direct effect on States Representatives, and the Comptroller
Environmental Health Risks and Safety or tribal governments, on the General of the United States prior to
Risks’’ (62 FR 19885, April 23, 1997); or relationship between the national publication of the rule in the Federal
Executive Order 13771, entitled government and the States or tribal Register. This action is not a ‘‘major
‘‘Reducing Regulations and Controlling governments, or on the distribution of rule’’ as defined by 5 U.S.C. 804(2).
Regulatory Costs’’ (82 FR 9339, February power and responsibilities among the
various levels of government or between List of Subjects in 40 CFR Part 180
3, 2017). This action does not contain
any information collections subject to the Federal Government and Indian Environmental protection,
OMB approval under the Paperwork tribes. Thus, the Agency has determined Administrative practice and procedure,
Reduction Act (PRA) (44 U.S.C. 3501 et that Executive Order 13132, entitled Agricultural commodities, Pesticides
seq.), nor does it require any special ‘‘Federalism’’ (64 FR 43255, August 10, and pests, Reporting and recordkeeping
considerations under Executive Order 1999) and Executive Order 13175, requirements.
12898, entitled ‘‘Federal Actions to entitled ‘‘Consultation and Coordination
Dated: February 12, 2018.
Address Environmental Justice in with Indian Tribal Governments’’ (65 FR
67249, November 9, 2000) do not apply Michael Goodis,
Minority Populations and Low-Income
to this action. In addition, this action Director, Registration Division, Office of
Populations’’ (59 FR 7629, February 16,
does not impose any enforceable duty or Pesticide Programs.
1994).
Since tolerances and exemptions that contain any unfunded mandate as Therefore, 40 CFR chapter I is
are established on the basis of a petition described under Title II of the Unfunded amended as follows:
under FFDCA section 408(d), such as Mandates Reform Act (UMRA) (2 U.S.C.
the exemptions in this final rule, do not 1501 et seq.). PART 180—[AMENDED]
This action does not involve any
require the issuance of a proposed rule,
technical standards that would require ■ 1. The authority citation for part 180
the requirements of the Regulatory
Agency consideration of voluntary continues to read as follows:
Flexibility Act (RFA) (5 U.S.C. 601 et consensus standards pursuant to section
seq.), do not apply. Authority: 21 U.S.C. 321(q), 346a and 371.
12(d) of the National Technology
This action directly regulates growers, Transfer and Advancement Act ■ 2. In § 180.910, add alphabetically the
food processors, food handlers, and food (NTTAA) (15 U.S.C. 272 note). inert ingredient to the table to read as
retailers, not States or tribes, nor does follows:
this action alter the relationships or VIII. Congressional Review Act
distribution of power and Pursuant to the Congressional Review § 180.910 Inert ingredients used pre- and
responsibilities established by Congress Act (5 U.S.C. 801 et seq.), EPA will post-harvest; exemptions from the
in the preemption provisions of FFDCA submit a report containing this rule and requirement of a tolerance.
section 408(n)(4). As such, the Agency other required information to the U.S. * * * * *

Inert ingredients Limits Uses

* * * * * * *
Distillates (petroleum), solvent-dewaxed heavy paraffinic (CAS Reg. No. 64742–65–0) ......................................................... ................ Carrier.

* * * * * * *

■ 3. In § 180.930, add alphabetically the § 180.930 Inert ingredients applied to
inert ingredient to the table to read as animals; exemptions from the requirement
of a tolerance.
follows:
* * * * *

Inert ingredients Limits Uses

* * * * * * *
Distillates (petroleum), solvent-dewaxed heavy paraffinic (CAS Reg. No. 64742–65–0) ......................................................... ................ Carrier.

* * * * * * *

[FR Doc. 2018–03759 Filed 2–22–18; 8:45 am] ENVIRONMENTAL PROTECTION ACTION: Final rule.
BILLING CODE 6560–50–P AGENCY
SUMMARY: This regulation establishes
40 CFR Part 180 tolerances for residues of quizalofop
ethyl in or on the commodities wheat
daltland on DSKBBV9HB2PROD with RULES

[EPA–HQ–OPP–2016–0360; FRL–9972–30] germ and milled byproducts, and
increases the tolerances in or on wheat
Quizalofop ethyl; Pesticide Tolerances forage, hay, and straw. Albaugh, LLC
requested these tolerances under the
AGENCY: Environmental Protection Federal Food, Drug, and Cosmetic Act
Agency (EPA). (FFDCA).

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8010 Federal Register / Vol. 83, No. 37 / Friday, February 23, 2018 / Rules and Regulations

(protective) assumptions in the ground population, or to infants and children VI. Statutory and Executive Order
and surface water modeling used to from aggregate exposure to quizalofop Reviews
assess exposure to quizalofop ethyl in ethyl residues. This action establishes tolerances
drinking water. These assessments will under FFDCA section 408(d) in
not underestimate the exposure and IV. Other Considerations
response to a petition submitted to the
risks posed by quizalofop ethyl. A. Analytical Enforcement Methodology Agency. The Office of Management and
E. Aggregate Risks and Determination of Budget (OMB) has exempted these types
An adequate enforcement of actions from review under Executive
Safety
methodology (Morse Meth-147, a liquid Order 12866, entitled ‘‘Regulatory
EPA determines whether acute and chromatography method using tandem
chronic dietary pesticide exposures are Planning and Review’’ (58 FR 51735,
mass spectrometry detection (LC–MS/ October 4, 1993). Because this action
safe by comparing aggregate exposure MS) for plant commodities including
estimates to the acute PAD (aPAD) and has been exempted from review under
wheat) is available to enforce the Executive Order 12866, this action is
chronic PAD (cPAD). For linear cancer tolerance expression.
risks, EPA calculates the lifetime not subject to Executive Order 13211,
probability of acquiring cancer given the The method may be requested from: entitled ‘‘Actions Concerning
estimated aggregate exposure. Short-, Chief, Analytical Chemistry Branch, Regulations That Significantly Affect
intermediate-, and chronic-term risks Environmental Science Center, 701 Energy Supply, Distribution, or Use’’ (66
are evaluated by comparing the Mapes Rd., Ft. Meade, MD 20755–5350; FR 28355, May 22, 2001); Executive
estimated aggregate food, water, and telephone number: (410) 305–2905; Order 13045, entitled ‘‘Protection of
residential exposure to the appropriate email address: residuemethods@ Children from Environmental Health
PODs to ensure that an adequate MOE epa.gov. Risks and Safety Risks’’ (62 FR 19885,
exists. April 23, 1997); or Executive Order
B. International Residue Limits 13771, entitled ‘‘Reducing Regulations
1. Acute risk. An acute aggregate risk
assessment takes into account acute In making its tolerance decisions, EPA and Controlling Regulatory Costs’’ (82
exposure estimates from dietary seeks to harmonize U.S. tolerances with FR 9339, February 3, 2017). This action
consumption of food and drinking international standards whenever does not contain any information
water. No adverse effect resulting from possible, consistent with U.S. food collections subject to OMB approval
a single-dose oral exposure was safety standards and agricultural under the Paperwork Reduction Act
identified and no acute dietary endpoint practices. EPA considers the (PRA) (44 U.S.C. 3501 et seq.), nor does
was selected. Therefore, quizalofop international maximum residue limits it require any special considerations
ethyl is not expected to pose an acute (MRLs) established by the Codex under Executive Order 12898, entitled
risk. Alimentarius Commission (Codex), as ‘‘Federal Actions to Address
2. Chronic risk. Using the exposure required by FFDCA section 408(b)(4). Environmental Justice in Minority
assumptions described in this unit for The Codex Alimentarius is a joint Populations and Low-Income
chronic exposure, EPA has concluded United Nations Food and Agriculture Populations’’ (59 FR 7629, February 16,
that chronic exposure to quizalofop Organization/World Health 1994).
ethyl from food and water will utilize Organization food standards program, Since tolerances and exemptions that
84% of the cPAD for all infants less than and it is recognized as an international are established on the basis of a petition
1-year old, the population group food safety standards-setting under FFDCA section 408(d), such as
receiving the greatest exposure. Most of organization in trade agreements to the tolerance in this final rule, do not
the dietary exposure is attributed to which the United States is a party. EPA require the issuance of a proposed rule,
drinking water, utilizing 75% of the may establish a tolerance that is the requirements of the Regulatory
cPAD for all infants less than 1-year old. different from a Codex MRL; however, Flexibility Act (RFA) (5 U.S.C. 601 et
There are no residential uses for FFDCA section 408(b)(4) requires that seq.), do not apply.
quizalofop ethyl. EPA explain the reasons for departing This action directly regulates growers,
3. Short- and intermediate-term risk. from the Codex level. The Codex has not food processors, food handlers, and food
Short- and intermediate-term aggregate established a MRL for quizalofop ethyl. retailers, not States or tribes, nor does
exposure takes into account short- and this action alter the relationships or
intermediate-term residential exposure C. Revisions to Petitioned-For distribution of power and
plus chronic exposure to food and water Tolerances responsibilities established by Congress
(considered to be a background in the preemption provisions of FFDCA
EPA determined that a separate section 408(n)(4). As such, the Agency
exposure level). Because there are no
tolerance is not needed for wheat bran, has determined that this action will not
residential uses, quizalofop ethyl is not
since it is included in the commodity have a substantial direct effect on States
expected to pose short- or intermediate-
definition for wheat, milled byproducts, or tribal governments, on the
term risk.
4. Aggregate cancer risk for U.S. which includes wheat bran, middlings, relationship between the national
population. As discussed in Unit III.A., and shorts. government and the States or tribal
EPA has concluded that regulating on V. Conclusion governments, or on the distribution of
the chronic reference dose will be power and responsibilities among the
protective of potential carcinogenicity. Therefore, tolerances are established various levels of government or between
Based on the results of the chronic risk for residues of quizalofop ethyl in or on the Federal Government and Indian
wheat, germ at 0.40 ppm and wheat, tribes. Thus, the Agency has determined
daltland on DSKBBV9HB2PROD with RULES

assessment, EPA concludes that
quizalofop ethyl is not expected to pose milled byproducts at 0.40 ppm. Existing that Executive Order 13132, entitled
a cancer risk to humans. tolerances are increased for residues of ‘‘Federalism’’ (64 FR 43255, August 10,
5. Determination of safety. Based on quizalofop ethyl in or on wheat, forage 1999) and Executive Order 13175,
these risk assessments, EPA concludes from 0.05 to 2.0 ppm; wheat, hay from entitled ‘‘Consultation and Coordination
that there is a reasonable certainty that 0.05 to 2.0 ppm; and wheat, straw from with Indian Tribal Governments’’ (65 FR
no harm will result to the general 0.05 to 0.80 ppm. 67249, November 9, 2000) do not apply

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Federal Register / Vol. 83, No. 37 / Friday, February 23, 2018 / Rules and Regulations 8011

to this action. In addition, this action Parts per Federal flood insurance that is not
Commodity
does not impose any enforceable duty or million otherwise generally available from
contain any unfunded mandate as private insurers. In return, communities
described under Title II of the Unfunded Wheat, milled byproducts ........... 0.40 agree to adopt and administer local
Mandates Reform Act (UMRA) (2 U.S.C. Wheat, straw ............................... 0.80 floodplain management measures aimed
1501 et seq.). at protecting lives and new construction
This action does not involve any * * * * * from future flooding. Section 1315 of
[FR Doc. 2018–03760 Filed 2–22–18; 8:45 am]
technical standards that would require the National Flood Insurance Act of
BILLING CODE 6560–50–P
Agency consideration of voluntary 1968, as amended, 42 U.S.C. 4022,
consensus standards pursuant to section prohibits the sale of NFIP flood
12(d) of the National Technology insurance unless an appropriate public
Transfer and Advancement Act DEPARTMENT OF HOMELAND body adopts adequate floodplain
(NTTAA) (15 U.S.C. 272 note). SECURITY management measures with effective
enforcement measures. The
VII. Congressional Review Act Federal Emergency Management
communities listed in this document no
Pursuant to the Congressional Review Agency
longer meet that statutory requirement
Act (5 U.S.C. 801 et seq.), EPA will for compliance with program
submit a report containing this rule and 44 CFR Part 64
regulations, 44 CFR part 59.
other required information to the U.S. [Docket ID FEMA–2018–0002; Internal Accordingly, the communities will be
Senate, the U.S. House of Agency Docket No. FEMA–8519] suspended on the effective date in the
Representatives, and the Comptroller third column. As of that date, flood
General of the United States prior to Suspension of Community Eligibility insurance will no longer be available in
publication of the rule in the Federal AGENCY: Federal Emergency the community. We recognize that some
Register. This action is not a ‘‘major Management Agency, DHS. of these communities may adopt and
rule’’ as defined by 5 U.S.C. 804(2). ACTION: Final rule. submit the required documentation of
List of Subjects in 40 CFR Part 180 legally enforceable floodplain
SUMMARY: This rule identifies management measures after this rule is
Environmental protection, communities where the sale of flood published but prior to the actual
Administrative practice and procedure, insurance has been authorized under suspension date. These communities
Agricultural commodities, Pesticides the National Flood Insurance Program will not be suspended and will continue
and pests, Reporting and recordkeeping (NFIP) that are scheduled for to be eligible for the sale of NFIP flood
requirements. suspension on the effective dates listed insurance. A notice withdrawing the
Dated: February 9, 2018. within this rule because of suspension of such communities will be
Michael Goodis, noncompliance with the floodplain published in the Federal Register.
Director, Registration Division, Office of management requirements of the In addition, FEMA publishes a Flood
Pesticide Programs. program. If the Federal Emergency Insurance Rate Map (FIRM) that
Management Agency (FEMA) receives identifies the Special Flood Hazard
Therefore, 40 CFR chapter I is Areas (SFHAs) in these communities.
documentation that the community has
amended as follows: The date of the FIRM, if one has been
adopted the required floodplain
PART 180—[AMENDED] management measures prior to the published, is indicated in the fourth
effective suspension date given in this column of the table. No direct Federal
■ 1. The authority citation for part 180 rule, the suspension will not occur and financial assistance (except assistance
continues to read as follows: a notice of this will be provided by pursuant to the Robert T. Stafford
Authority: 21 U.S.C. 321(q), 346a and 371. publication in the Federal Register on a Disaster Relief and Emergency
subsequent date. Also, information Assistance Act not in connection with a
■ 2. In § 180.441, flood) may be provided for construction
identifying the current participation
■ a. Add alphabetically the entries or acquisition of buildings in identified
status of a community can be obtained
‘‘Wheat, germ’’ and ‘‘Wheat, milled SFHAs for communities not
from FEMA’s Community Status Book
byproducts’’ to the table in paragraph participating in the NFIP and identified
(CSB). The CSB is available at https://
(a)(1). for more than a year on FEMA’s initial
www.fema.gov/national-flood-
b. Revise the entries ‘‘Wheat, forage’’; FIRM for the community as having
insurance-program-community-status-
‘‘Wheat, hay’’; and ‘‘Wheat, straw’’ in flood-prone areas (section 202(a) of the
book.
the table in paragraph (a)(1). Flood Disaster Protection Act of 1973,
The additions and revisions read as DATES: The effective date of each
42 U.S.C. 4106(a), as amended). This
follows: community’s scheduled suspension is
prohibition against certain types of
the third date (‘‘Susp.’’) listed in the
§ 180.441 Quizalofop ethyl; tolerances for Federal assistance becomes effective for
third column of the following tables.
residues. the communities listed on the date
FOR FURTHER INFORMATION CONTACT: If shown in the last column. The
(a) * * *
you want to determine whether a Administrator finds that notice and
(1) * * *
particular community was suspended public comment procedures under 5
Parts per on the suspension date or for further U.S.C. 553(b), are impracticable and
Commodity information, contact Adrienne L.
million unnecessary because communities listed
Sheldon, PE, CFM, Federal Insurance
daltland on DSKBBV9HB2PROD with RULES

in this final rule have been adequately
and Mitigation Administration, Federal notified.
* * * * * Emergency Management Agency, 400 C
Wheat, forage ............................. 2.0 Street SW, Washington, DC 20472, (202)
Each community receives 6-month,
Wheat, germ ............................... 0.40 90-day, and 30-day notification letters
212–3966. addressed to the Chief Executive Officer
* * * * * SUPPLEMENTARY INFORMATION: The NFIP stating that the community will be
Wheat, hay ................................. 2.0 enables property owners to purchase suspended unless the required

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Document Created: 2018-02-23 01:32:51
Document Modified: 2018-02-23 01:32:51

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 February 23, 2018. Objections and requests for hearings must be received on or before April 24, 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 8006
CFR Associated		Environmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements