[Federal Register Volume 82, Number 208 (Monday, October 30, 2017)]
[Rules and Regulations]
[Pages 50084-50089]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-23439]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2017-0155; FRL-9968-12]
Hexythiazox; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation amends an existing tolerance for residues of
the ovicide/miticide hexythiazox in/on hop, dried cones, by increasing
the current tolerance from 2.0 parts per million (ppm) to 20 ppm. Gowan
Company requested modification of this tolerance under the Federal
Food, Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective October 30, 2017. Objections and
requests for hearings must be received
[[Page 50085]]
on or before December 29, 2017, and must be filed in accordance with
the instructions provided in 40 CFR part 178 (see also Unit I.C. of the
SUPPLEMENTARY INFORMATION).
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2017-0155, 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 L. Goodis, P.E., Director,
Registration Division (7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460-0001; main telephone number: (703) 305-7090; email
address: [email protected].
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
B. How can I get electronic access to other related information?
You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.
C. How can I file an objection or hearing request?
Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2017-0155 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
December 29, 2017. Addresses for mail and hand delivery of objections
and hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2017-0155, 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 June 8, 2017 (82 FR 26641) (FRL-9961-
14), EPA issued a document pursuant to the Federal Food, Drug, and
Cosmetic Act (FFDCA) section 408(d)(3), 21 U.S.C. 346a(d)(3),
announcing the filing of a pesticide petition (PP #6F8489) by Gowan
Company, P.O. Box 5569, Yuma, AZ 85366-5569. This petition requested
that 40 CFR 180.448 be amended by establishing a tolerance for residues
of hexythiazox in or on hop, dried cones at 20 ppm. This document
referenced a summary of the petition prepared by Gowan Company, the
registrant, which is available in the docket, http://www.regulations.gov. No comments were received in response to the
referenced notice of filing.
III. Aggregate Risk Assessment and Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
.''
Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for hexythiazox including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with hexythiazox 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.
Hexythiazox has low acute toxicity by the oral, dermal, and
inhalation routes of exposure. It produces mild eye irritation and is
not a skin irritant or skin sensitizer. Hexythiazox is associated with
toxicity of the liver and
[[Page 50086]]
adrenals following subchronic and chronic exposure to dogs, rats, and
mice, with the dog being the most sensitive species. The prenatal
developmental studies in rabbits and rats and the two-generation
reproduction study in rats showed no indication of increased
susceptibility to in utero or postnatal exposure to hexythiazox.
Reproductive toxicity was not observed. There is no concern for
immunotoxicity or neurotoxicity following exposure to hexythiazox. The
toxicology database for hexythiazox does not show any evidence of
treatment-related effects on the immune system.
Hexythiazox is classified as ``Likely to be Carcinogenic to
Humans'' based on a treatment-related increase in benign and malignant
liver tumors in female mice and the presence of mammary gland tumors
(fibroadenomas) in male rats; however, the evidence as a whole was not
strong enough to warrant the use of a linear low dose extrapolation
model applied to the animal data (Q1*) for a quantitative
estimation of human risk because the common liver tumors (benign and
malignant) were only observed in high-dose female mice, and benign
mammary gland tumors were only observed in high-dose male rats. Since
the effects seen in the study that serves as the basis for the chronic
reference dose (cRfD) occurred at doses substantially below the lowest
dose that induced tumors (and there is no mutagenic concern for
hexythiazox), the cRfD is considered protective of all chronic effects,
including potential carcinogenicity.
Specific information on the studies received and the nature of the
adverse effects caused by hexythiazox 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 within the document entitled ``Hexythiazox. Human
Health Risk Assessment for Amended Use on Hops,'' dated September 5,
2017, which can be found in docket ID number EPA-HQ-OPP-2017-0155.
B. Toxicological Points of Departure/Levels of Concern
Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm. A summary of the toxicological
endpoints for hexythiazox used for human risk assessment is shown in
the Table of this unit.
Table--Summary of Toxicological Doses and Endpoints for Hexythiazox for Use in Human Health Risk Assessment
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Point of departure
Exposure/scenario and uncertainty/ RfD, PAD, LOC for Study and toxicological effects
safety factors risk assessment
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Acute Dietary (All populations).. No risk is expected from this exposure scenario as no hazard was identified
in any toxicity study for this duration of exposure.
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Chronic Dietary (All populations) NOAEL= 2.5 mg/kg/day Chronic RfD = 0.025 One-Year Feeding Toxicity Study--
UFA = 10x........... mg/kg/day. Dogs.
UFH = 10x........... cPAD = 0.025....... LOAEL = 12.5 mg/kg/day based on
FQPA SF = 1x........ increased absolute and relative
adrenal weights, and associated
adrenal histopathology.
Incidental Oral Short-Term (1 to NOAEL= 30 mg/kg/day. Residential LOC for 2-Generation Reproduction Study--
30 days) and Intermediate-Term UFA = 10x........... MOE = 100. Rat.
(1 to 6 months). UFH = 10x........... LOAEL = 180 mg/kg/day, based on
FQPA SF = 1x........ decreased pup body weight during
lactation and delayed hair growth
and/or eye opening, and decreased
parental body-weight gain and
increased absolute and relative
liver, kidney, and adrenal
weights.
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Dermal Short- and Intermediate- A quantitative dermal risk assessment is not necessary since no dermal hazard
term. is anticipated. There is no evidence of increased quantitative or
qualitative susceptibility of the young following in utero and pre-and post-
natal exposure to hexythiazox.
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Inhalation Short-Term (1 to 30 Oral NOAEL= 30 mg/kg/ Residential LOC for 2-Generation Reproduction Study--
days) and Intermediate-Term (1 day. MOE = 100. Rat.
to 6 months). UFA = 10x........... LOAEL = 180 mg/kg/day, based on
UFH = 10x........... decreased pup body weight during
FQPA SF = 1x........ lactation and delayed hair growth
and/or eye opening, and decreased
parental body-weight gain and
increased absolute and relative
liver, kidney, and adrenal
weights.
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[[Page 50087]]
Cancer (oral, dermal, and Classification: ``Likely to be Carcinogenic to Humans.'' A quantification of
inhalation). risk using a non-linear approach; i.e., RfD, for hexythiazox will adequately
account for all chronic toxicity, including carcinogenicity, that could
result from exposure to hexythiazox.
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FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor.
UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among
members of the human population (intraspecies).
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to hexythiazox, EPA considered exposure under the petitioned-
for tolerances as well as all existing hexythiazox tolerances in 40 CFR
180.448. EPA assessed dietary exposures from hexythiazox 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 toxic effects
attributable to a single dose of hexythiazox were observed in the
toxicology database; therefore, a quantitative acute dietary exposure
and risk assessment is unnecessary.
ii. Chronic exposure. In conducting the chronic dietary (food and
drinking water) exposure assessment, EPA used the Dietary Exposure
Evaluation Model (DEEM-FCID), Version 3.16, which uses food consumption
data from the U.S. Department of Agriculture's National Health and
Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA)
from 2003-2008. As to residue levels in food, EPA used tolerance-level
residues, assumed 100 percent crop treated (PCT), and incorporated DEEM
7.81 default processing factors when processing data were not
available.
iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that a nonlinear RfD approach is appropriate for assessing
cancer risk to hexythiazox. Cancer risk was assessed using the same
exposure estimates as discussed in Unit III.C.1.ii., Chronic exposure.
iv. Anticipated residue and percent crop treated (PCT) information.
EPA did not use anticipated residue and/or PCT information in the
dietary assessment for hexythiazox. 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 hexythiazox in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of hexythiazox. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at http://www.epa.gov/oppefed1/models/water/index.htm.
Surface water and groundwater estimated drinking water
concentrations (EDWCs) do not result in any change to the existing
EDWCs determined from a recent drinking water assessment derived on
hops. Specifically, since hops is already a registered use that was
recently assessed during registration review, no new drinking water
scenarios were identified with this proposed increase in application
rates that would require a new drinking water assessment to be
conducted. In fact, the highest EDWCs associated with all uses of
hexythiazox continue to be from use on sorghum in the Western U.S.,
using the Pesticide Root Zone Model (PRZM) surface water modeling
scenario. Furthermore, based on the Agency's previous assessment, the
EDWCs of hexythiazox for chronic exposures are estimated to be 4.3
parts per billion (ppb) for surface water and 2.4 ppb for ground water
(DP 433290, 5/9/2016; DP 404023, 1/17/2012), and the higher of these
values was used in the dietary exposure model to assess chronic dietary
risk.
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). Hexythiazox is
currently registered for the following residential uses, including
ornamental landscape plantings, turf, and fruit and nut trees in
residential sites.
EPA assessed residential exposure using the following assumptions:
Residential handler exposures are expected to be short-term (1 to 30
days) via either the dermal or inhalation routes of exposures. Since a
quantitative dermal risk assessment is not needed for hexythiazox,
handler MOEs were calculated for the inhalation route of exposure only.
EPA uses the term ``post-application'' to describe exposure to
individuals that occur as a result of being in an environment that has
been previously treated with a pesticide. There is potential for post-
application for individuals exposed as a result of being in an
environment that has been previously treated with hexythiazox. Adult
residential post-application dermal exposures were not assessed since
no dermal hazard was identified for hexythiazox. The residential post-
application exposure assessment for children included incidental oral
exposure resulting from transfer of residues from the hand-to-mouth,
object to- mouth, and from incidental ingestion of soil.
Further information regarding EPA standard assumptions and generic
inputs for residential exposures may be found at http://www.epa.gov/pesticides/science/residential-exposure-sop.html.
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 hexythiazox to share a common mechanism of
toxicity with any other substances, and hexythiazox does not appear to
produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action; therefore, EPA has assumed that
hexythiazox does not have a common mechanism of toxicity with other
substances. For information
[[Page 50088]]
regarding EPA's efforts to determine which chemicals have a common
mechanism of toxicity and to evaluate the cumulative effects of such
chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.
D. Safety Factor for Infants and Children
1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the Food Quality
Protection Act Safety Factor (FQPA 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. The prenatal and postnatal
toxicology data base indicates no increased susceptibility of rats or
rabbits to in utero and/or postnatal exposure to hexythiazox.
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 hexythiazox is complete.
ii. There is no indication that hexythiazox is a neurotoxic
chemical and there is no need for a developmental neurotoxicity study
or additional UFs to account for neurotoxicity.
iii. There is no evidence that hexythiazox 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. EPA made conservative (protective) assumptions in the ground
and surface water modeling used to assess exposure to hexythiazox 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 hexythiazox.
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 toxic effects attributable to a single dose of
hexythiazox were observed in the toxicology database; therefore, a
quantitative acute aggregate risk assessment for hexythiazox is not
required.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
hexythiazox from food and water will utilize 93% of the cPAD for
children 1-2 years of age, 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
hexythiazox 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).
Hexythiazox 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 hexythiazox. Using the
exposure assumptions described in this unit for short-term exposures,
EPA has concluded the combined short-term food, drinking water, and
residential inhalation exposures result in an aggregate MOE for adults
(7,500) that greatly exceeds the LOC of 100, and is 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).
Hexythiazox is currently registered for uses that could result in
intermediate-term residential exposure, and the Agency has determined
that it is appropriate to aggregate chronic exposure through food and
water with intermediate-term residential exposures to hexythiazox.
Using the exposure assumptions described in this unit for intermediate-
term exposures, EPA has concluded the combined intermediate-term food,
drinking water, and residential oral exposures result in an aggregate
MOE for children (1,150) that greatly exceeds the LOC of 100, and is
not of concern.
5. Aggregate cancer risk for U.S. population. As discussed in Unit
III. C.1.iii., EPA concluded that regulation based on the cRfD will be
protective for both chronic and carcinogenic risks. As noted in this
unit, there are no chronic risks of concern; therefore, the Agency
concludes that aggregate exposure to hexythiazox will not pose a cancer
risk.
6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the U.S. general population, or to infants and children from
aggregate exposure to hexythiazox residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
An adequate High performance liquid chromatography using ultra-
violet detection (HPLC/UV) analytical method is available for the
enforcement of tolerances for residues of hexythiazox and its
metabolites containing the PT-1-3 moiety in crop and livestock
commodities. This method is listed in the U.S. EPA Index of Residue
Analytical Methods under hexythiazox as method AMR-985-87. The limit of
quantification (LOQ) for hexythiazox residues is 0.02 ppm.
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 Federal
Food, Drug and Cosmetic Act (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,
[[Page 50089]]
FFDCA section 408(b)(4) requires that EPA explain the reasons for
departing from the Codex level.
Codex has established an MRL for residues of hexythiazox on hops at
3 ppm. The U.S. tolerance for residues of hexythiazox on hops cannot be
harmonized based on approved label instructions. Based on available
residue data, compliance with label instructions would result in
exceedances of a tolerance harmonized with the Codex MRL.
V. Conclusion
Therefore, the existing tolerance for residues of the ovicide/
miticide hexythiazox and its metabolites containing the (4-
chlorophenyl)-4-methyl-2-oxo-3-thiazolidine moiety in/on hop, dried
cones is increased from 2.0 ppm to 20 ppm.
VI. Statutory and Executive Order Reviews
This action amends an existing tolerance under FFDCA section 408(d)
in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this action has been
exempted from review under Executive Order 12866, this action is not
subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997). This action does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This action directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(UMRA) (2 U.S.C. 1501 et seq.).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).
VII. Congressional Review Act
Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: October 6, 2017.
Daniel J. Rosenblatt,
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. Section 180.448 is amended by revising the entry ``Hop, dried
cones'' in the table in paragraph (a) to read as follows:
Sec. 180.448 Hexythiazox; tolerances for residues.
(a) * * *
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Hop, dried cones............................................ 20
* * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. 2017-23439 Filed 10-27-17; 8:45 am]
BILLING CODE 6560-50-P