80 FR 48753 - Hexythiazox; Pesticide Tolerances

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 80, Issue 157 (August 14, 2015)

Page Range		48753-48757
FR Document		2015-20012

This regulation establishes tolerances for residues of hexythiazox in or on wheat, forage; wheat, hay; wheat, grain; and wheat, straw. Gowan Company requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

Federal Register, Volume 80 Issue 157 (Friday, August 14, 2015)

[Federal Register Volume 80, Number 157 (Friday, August 14, 2015)]
[Rules and Regulations]
[Pages 48753-48757]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2015-20012]

[[Page 48753]]

-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2014-0804; FRL-9931-30]

Hexythiazox; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This regulation establishes tolerances for residues of
hexythiazox in or on wheat, forage; wheat, hay; wheat, grain; and
wheat, straw. Gowan Company requested these tolerances under the
Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective August 14, 2015. Objections and
requests for hearings must be received on or before October 13, 2015,
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-2014-0804, 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: Susan Lewis, 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-2014-0804 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
October 13, 2015. 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-2014-0804, 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 February 11, 2015 (80 FR 7559) (FRL-
9921-94), 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
4F8315) by Gowan Company, P.O. Box 5569, Yuma, AZ 85366. The petition
requested that 40 CFR 180.448 be amended by establishing tolerances for
residues of the insecticide hexythiazox and its metabolites containing
the (4-chlorophenyl)-4-methyl-2-oxo-3-thiazolidine moiety, in or on
wheat, forage at 6.0 parts per million (ppm); wheat, hay at 30 ppm;
wheat, grain at 0.02; and wheat, straw at 8.0 ppm. That document
referenced a summary of the petition prepared by Gowan Company, the
registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the
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

[[Page 48754]]

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, is not
a dermal irritant, and is negative for dermal sensitization.
Hexythiazox is associated with toxicity of the liver and 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 2-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''; however, the evidence as a whole is not
strong enough to warrant a quantitative estimation of human cancer
risk. Since the effects seen in the study that serves as the basis for
the chronic RfD occurred at doses substantially below the lowest dose
that induced tumors, the chronic RfD 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 in document: Hexythiazox. Human Health Risk
Assessment to Support New Uses on Wheat and Pepper/Eggplant Subgroup 8-
10B in docket ID number EPA-HQ-OPP-2014-0804.

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 Table 1 of this unit.

Table 1--Summary of Toxicological Doses and Endpoints for Hexythiazox for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
Point of departure and
Exposure/Scenario uncertainty/Safety RfD, PAD, LOC for risk Study and toxicological
factors assessment effects
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------
Chronic dietary (All populations).. NOAEL = 2.5 mg/kg/day. Chronic RfD = 0.025 mg/ One-Year Toxicity Feeding
UFA = 10x............. kg/day. Study--Dog.
UFH = 10x............. cPAD = 0.025.......... LOAEL = 12.5 mg/kg/day
FQPA SF = 1x.......... based on increased
absolute and relative
adrenal weights and
associated adrenal
histopathology.
Incidental oral short-term (1 to 30 NOAEL = 30 mg/kg/day.. LOC for MOE = 100..... 2-Generation Reproduction
days ) and intermediate-term (1 to UFA = 10x............. Study--Rat.
6 months). UFH = 10x............. LOAEL = 180 mg/kg/day based
FQPA SF = 1x.......... on 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.
Co-Critical
13-Week Oral Toxicity
Study--Rat.
NOAEL = 5.5 mg/kg/day.
LOAEL = 38 mg/kg/day, based
on increased absolute and
relative liver weights in
both sexes, increased
relative ovarian and
kidney weights, and fatty
degeneration of the
adrenal zona fasciculata.
@397.5/257.6 mg/kg/day,
decreased body-weight gain
in females, slight
swelling of hepatocytes in
central zone (both sexes),
increased incidence of
glomerulonephrosis in
males, increased adrenal
weights.
----------------------------------------------------------------------------

[[Page 48755]]

Cancer (oral, dermal, inhalation).. Classification: ``Likely to be Carcinogenic to Humans''. Insufficient
evidence to warrant a quantitative estimation of human risk using a cancer
slope factor based on the common liver tumors (benign and malignant)
observed only in high dose female mice, and benign mammary gland tumors of
no biological significance, observed only in high dose male rats in the
absence of mutagenic concerns. The chronic RfD is protective of all
chronic effects including potential carcinogenicity of hexythiazox.
----------------------------------------------------------------------------------------------------------------
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 such effects were
identified in the toxicological studies for hexythiazox; 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 U.S. Department
of Agriculture's 2003-2008 National Health and Nutrition Examination
Survey, What We Eat in America (NHANES/WWEIA). As to residue levels in
food, EPA used tolerance level residues, assumed 100 percent crop
treated (PCT), and incorporated Dietary Exposure Evaluation Model
(DEEM) default processing factors when processing data were not
available.
iii. Cancer. EPA determines whether quantitative cancer exposure
and risk assessments are appropriate for a food-use pesticide based on
the weight of the evidence from cancer studies and other relevant data.
Cancer risk is quantified using a linear or nonlinear approach. If
sufficient information on the carcinogenic mode of action is available,
a threshold or nonlinear approach is used and a cancer RfD is
calculated based on an earlier noncancer key event. If carcinogenic
mode of action data are not available, or if the mode of action data
determines a mutagenic mode of action, a default linear cancer slope
factor approach is utilized. 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.
Based on the Surface Water Concentration Calculator (SWCC), the
estimated drinking water concentrations (EDWCs) of hexythiazox for
chronic exposures for non-cancer assessments are estimated to be 4.3
ppb for surface water. Since groundwater residues are not expected to
exceed surface water residues, surface water residues were used in the
dietary risk assessment. Modeled estimates of drinking water
concentrations were directly entered into the dietary exposure model.
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 uses that could result in
residential exposures: ornamental plantings, turf, and fruit and nut
trees in residential settings. 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. Both adults and children may be exposed to
hexythiazox residues from contact with treated lawns or treated
residential plants. Post application exposures are expected to be
short-term (1 to 30 days) and intermediate-term (1 to 6 months) in
duration. Adult postapplication exposures were not assessed since no
quantitative dermal risk assessment is needed for hexythiazox and
inhalation exposures are typically negligible in outdoor settings. The
exposure assessment for children included incidental oral exposure
resulting from transfer of residues from the hands or objects to the
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 regarding EPA's efforts to determine which
chemicals have a common

[[Page 48756]]

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 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. 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
postapplication 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 adverse effect resulting from a single oral exposure
was identified and no acute dietary endpoint was selected. Therefore,
hexythiazox 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
hexythiazox from food and water will utilize 81% 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, water,
and residential exposures result in aggregate MOEs of 1291 for children
and 8626 for adults. Because EPA's level of concern for hexythiazox is
a 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).
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 that the combined
intermediate-term food, water, and residential exposures result in
aggregate MOEs of 1474 for children and 8808 for adults. Because EPA's
level of concern for hexythiazox is a MOE of 100 or below, these MOEs
are 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 chronic
reference dose will be protective for both chronic and carcinogenic
risks. As noted in this unit there are no chronic risks of concern.
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 hexythiazox residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

Adequate enforcement methodology (high performance liquid
chromatography method with UV detection (HPLC/UV)) is available to
enforce the tolerance expression. This method is listed in the U.S. EPA
Index of Residue Analytical Methods under hexythiazox as method AMR-
985-87.

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 hexythiazox in/on wheat,
therefore, there are no harmonization issues associated with this
action.

V. Conclusion

Therefore, tolerances are established for residues of hexythiazox
and its

[[Page 48757]]

metabolites containing the (4-chlorophenyl)-4-methyl-2-oxo-3-
thiazolidine moiety, as petitioned.

VI. Statutory and Executive Order Reviews

This action establishes tolerances under FFDCA section 408(d) in
response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this action has been
exempted from review under Executive Order 12866, this action is not
subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children From Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997). This action does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions To Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This action directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(UMRA) (2 U.S.C. 1501 et seq.).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

Dated: August 6, 2015.
Susan Lewis,
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. 180.448, add alphabetically the following commodities to
the table in paragraph (c) to read as follows:

Sec. 180.448 Hexythiazox; tolerances for residues.

* * * * *
(c) * * *

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

* * * * *
Wheat, forage (EPA Region 11 only)...................... 6.0
Wheat, hay (EPA Region 11 only)......................... 30
Wheat, grain (EPA Region 11 only)....................... 0.02
Wheat, straw (EPA Region 11 only)....................... 8.0
------------------------------------------------------------------------

* * * * *
[FR Doc. 2015-20012 Filed 8-13-15; 8:45 am]
BILLING CODE 6560-50-P

Federal Register / Vol. 80, No. 157 / Friday, August 14, 2015 / Rules and Regulations 48753

ENVIRONMENTAL PROTECTION applies to them. Potentially affected follow the instructions at http://
AGENCY entities may include: www.epa.gov/dockets/contacts.html.
• Crop production (NAICS code 111). Additional instructions on
40 CFR Part 180 • Animal production (NAICS code commenting or visiting the docket,
112). along with more information about
[EPA–HQ–OPP–2014–0804; FRL–9931–30]
• Food manufacturing (NAICS code dockets generally, is available at
Hexythiazox; Pesticide Tolerances 311). http://www.epa.gov/dockets.
• Pesticide manufacturing (NAICS
AGENCY: Environmental Protection code 32532). II. Summary of Petitioned-For
Agency (EPA). Tolerance
B. How can I get electronic access to In the Federal Register of February
ACTION: Final rule.
other related information? 11, 2015 (80 FR 7559) (FRL–9921–94),
SUMMARY: This regulation establishes You may access a frequently updated EPA issued a document pursuant to
tolerances for residues of hexythiazox in electronic version of EPA’s tolerance FFDCA section 408(d)(3), 21 U.S.C.
or on wheat, forage; wheat, hay; wheat, regulations at 40 CFR part 180 through 346a(d)(3), announcing the filing of a
grain; and wheat, straw. Gowan the Government Printing Office’s e-CFR pesticide petition (PP 4F8315) by
Company requested these tolerances site at http://www.ecfr.gov/cgi-bin/text- Gowan Company, P.O. Box 5569, Yuma,
under the Federal Food, Drug, and idx?&c=ecfr&tpl=/ecfrbrowse/Title40/ AZ 85366. The petition requested that
Cosmetic Act (FFDCA). 40tab_02.tpl. 40 CFR 180.448 be amended by
DATES: This regulation is effective establishing tolerances for residues of
August 14, 2015. Objections and C. How can I file an objection or hearing
the insecticide hexythiazox and its
requests for hearings must be received request? metabolites containing the (4-
on or before October 13, 2015, and must Under FFDCA section 408(g), 21 chlorophenyl)-4-methyl-2-oxo-3-
be filed in accordance with the U.S.C. 346a, any person may file an thiazolidine moiety, in or on wheat,
instructions provided in 40 CFR part objection to any aspect of this regulation forage at 6.0 parts per million (ppm);
178 (see also Unit I.C. of the and may also request a hearing on those wheat, hay at 30 ppm; wheat, grain at
SUPPLEMENTARY INFORMATION). objections. You must file your objection 0.02; and wheat, straw at 8.0 ppm. That
ADDRESSES: The docket for this action, or request a hearing on this regulation document referenced a summary of the
identified by docket identification (ID) in accordance with the instructions petition prepared by Gowan Company,
number EPA–HQ–OPP–2014–0804, is provided in 40 CFR part 178. To ensure the registrant, which is available in the
available at http://www.regulations.gov proper receipt by EPA, you must docket, http://www.regulations.gov.
or at the Office of Pesticide Programs identify docket ID number EPA–HQ– There were no comments received in
Regulatory Public Docket (OPP Docket) OPP–2014–0804 in the subject line on response to the notice of filing.
in the Environmental Protection Agency the first page of your submission. All
III. Aggregate Risk Assessment and
Docket Center (EPA/DC), West William objections and requests for a hearing
Determination of Safety
Jefferson Clinton Bldg., Rm. 3334, 1301 must be in writing, and must be
Constitution Ave. NW., Washington, DC received by the Hearing Clerk on or Section 408(b)(2)(A)(i) of FFDCA
20460–0001. The Public Reading Room before October 13, 2015. Addresses for allows EPA to establish a tolerance (the
is open from 8:30 a.m. to 4:30 p.m., mail and hand delivery of objections legal limit for a pesticide chemical
Monday through Friday, excluding legal and hearing requests are provided in 40 residue in or on a food) only if EPA
holidays. The telephone number for the CFR 178.25(b). determines that the tolerance is ‘‘safe.’’
Public Reading Room is (202) 566–1744, In addition to filing an objection or Section 408(b)(2)(A)(ii) of FFDCA
and the telephone number for the OPP hearing request with the Hearing Clerk defines ‘‘safe’’ to mean that ‘‘there is a
Docket is (703) 305–5805. Please review as described in 40 CFR part 178, please reasonable certainty that no harm will
the visitor instructions and additional submit a copy of the filing (excluding result from aggregate exposure to the
information about the docket available any Confidential Business Information pesticide chemical residue, including
at http://www.epa.gov/dockets. (CBI)) for inclusion in the public docket. all anticipated dietary exposures and all
Information not marked confidential other exposures for which there is
FOR FURTHER INFORMATION CONTACT:
pursuant to 40 CFR part 2 may be reliable information.’’ This includes
Susan Lewis, Registration Division
disclosed publicly by EPA without prior exposure through drinking water and in
(7505P), Office of Pesticide Programs,
notice. Submit the non-CBI copy of your residential settings, but does not include
Environmental Protection Agency, 1200
objection or hearing request, identified occupational exposure. Section
Pennsylvania Ave. NW., Washington,
by docket ID number EPA–HQ–OPP– 408(b)(2)(C) of FFDCA requires EPA to
DC 20460–0001; main telephone
2014–0804, by one of the following give special consideration to exposure
number: (703) 305–7090; email address:
methods: of infants and children to the pesticide
RDFRNotices@epa.gov.
• Federal eRulemaking Portal: http:// chemical residue in establishing a
SUPPLEMENTARY INFORMATION:
www.regulations.gov. Follow the online tolerance and to ‘‘ensure that there is a
I. General Information instructions for submitting comments. reasonable certainty that no harm will
Do not submit electronically any result to infants and children from
A. Does this action apply to me? information you consider to be CBI or aggregate exposure to the pesticide
You may be potentially affected by other information whose disclosure is chemical residue. . . .’’
this action if you are an agricultural restricted by statute. Consistent with FFDCA section
producer, food manufacturer, or • Mail: OPP Docket, Environmental 408(b)(2)(D), and the factors specified in
tkelley on DSK3SPTVN1PROD with RULES

pesticide manufacturer. The following Protection Agency Docket Center (EPA/ FFDCA section 408(b)(2)(D), EPA has
list of North American Industrial DC), (28221T), 1200 Pennsylvania Ave. reviewed the available scientific data
Classification System (NAICS) codes is NW., Washington, DC 20460–0001. and other relevant information in
not intended to be exhaustive, but rather • Hand Delivery: To make special support of this action. EPA has
provides a guide to help readers arrangements for hand delivery or sufficient data to assess the hazards of
determine whether this document delivery of boxed information, please and to make a determination on

VerDate Sep<11>2014 20:18 Aug 13, 2015 Jkt 235001 PO 00000 Frm 00071 Fmt 4700 Sfmt 4700 E:\FR\FM\14AUR1.SGM 14AUR1

48756 Federal Register / Vol. 80, No. 157 / Friday, August 14, 2015 / Rules and Regulations

mechanism of toxicity and to evaluate safe by comparing aggregate exposure Using the exposure assumptions
the cumulative effects of such estimates to the acute PAD (aPAD) and described in this unit for intermediate-
chemicals, see EPA’s Web site at chronic PAD (cPAD). For linear cancer term exposures, EPA has concluded that
http://www.epa.gov/pesticides/ risks, EPA calculates the lifetime the combined intermediate-term food,
cumulative. probability of acquiring cancer given the water, and residential exposures result
estimated aggregate exposure. Short-, in aggregate MOEs of 1474 for children
D. Safety Factor for Infants and intermediate-, and chronic-term risks and 8808 for adults. Because EPA’s level
Children are evaluated by comparing the of concern for hexythiazox is a MOE of
1. In general. Section 408(b)(2)(C) of estimated aggregate food, water, and 100 or below, these MOEs are not of
FFDCA provides that EPA shall apply residential exposure to the appropriate concern.
an additional tenfold (10X) margin of PODs to ensure that an adequate MOE 5. Aggregate cancer risk for U.S.
safety for infants and children in the exists. population. As discussed in Unit III.
case of threshold effects to account for 1. Acute risk. An acute aggregate risk C.1.iii., EPA concluded that regulation
prenatal and postnatal toxicity and the assessment takes into account acute based on the chronic reference dose will
completeness of the database on toxicity exposure estimates from dietary be protective for both chronic and
and exposure unless EPA determines consumption of food and drinking carcinogenic risks. As noted in this unit
based on reliable data that a different water. No adverse effect resulting from there are no chronic risks of concern.
margin of safety will be safe for infants a single oral exposure was identified 6. Determination of safety. Based on
and children. This additional margin of and no acute dietary endpoint was these risk assessments, EPA concludes
safety is commonly referred to as the selected. Therefore, hexythiazox is not that there is a reasonable certainty that
FQPA Safety Factor (SF). In applying expected to pose an acute risk. no harm will result to the general
this provision, EPA either retains the 2. Chronic risk. Using the exposure population, or to infants and children
default value of 10X, or uses a different assumptions described in this unit for from aggregate exposure to hexythiazox
additional safety factor when reliable chronic exposure, EPA has concluded residues.
data available to EPA support the choice that chronic exposure to hexythiazox
of a different factor. from food and water will utilize 81% of IV. Other Considerations
2. Prenatal and postnatal sensitivity. the cPAD for children 1–2 years of age, A. Analytical Enforcement Methodology
The prenatal and postnatal toxicology the population group receiving the
data base indicates no increased greatest exposure. Based on the Adequate enforcement methodology
susceptibility of rats or rabbits to in explanation in Unit III.C.3., regarding (high performance liquid
utero and/or postnatal exposure to residential use patterns, chronic chromatography method with UV
hexythiazox. residential exposure to residues of detection (HPLC/UV)) is available to
3. Conclusion. EPA has determined hexythiazox is not expected. enforce the tolerance expression. This
that reliable data show the safety of 3. Short-term risk. Short-term method is listed in the U.S. EPA Index
infants and children would be aggregate exposure takes into account of Residue Analytical Methods under
adequately protected if the FQPA SF short-term residential exposure plus hexythiazox as method AMR–985–87.
were reduced to 1X. That decision is chronic exposure to food and water B. International Residue Limits
based on the following findings: (considered to be a background
i. The toxicity database for exposure level). In making its tolerance decisions, EPA
hexythiazox is complete. Hexythiazox is currently registered for seeks to harmonize U.S. tolerances with
ii. There is no indication that uses that could result in short-term international standards whenever
hexythiazox is a neurotoxic chemical residential exposure, and the Agency possible, consistent with U.S. food
and there is no need for a has determined that it is appropriate to safety standards and agricultural
developmental neurotoxicity study or aggregate chronic exposure through food practices. EPA considers the
additional UFs to account for and water with short-term residential international maximum residue limits
neurotoxicity. exposures to hexythiazox. (MRLs) established by the Codex
iii. There is no evidence that Using the exposure assumptions Alimentarius Commission (Codex), as
hexythiazox results in increased described in this unit for short-term required by FFDCA section 408(b)(4).
susceptibility in in utero rats or rabbits exposures, EPA has concluded the The Codex Alimentarius is a joint
in the prenatal developmental studies or combined short-term food, water, and United Nations Food and Agriculture
in young rats in the 2-generation residential exposures result in aggregate Organization/World Health
reproduction study. MOEs of 1291 for children and 8626 for Organization food standards program,
iv. There are no residual uncertainties adults. Because EPA’s level of concern and it is recognized as an international
identified in the exposure databases. for hexythiazox is a MOE of 100 or food safety standards-setting
EPA made conservative (protective) below, these MOEs are not of concern. organization in trade agreements to
assumptions in the ground and surface 4. Intermediate-term risk. which the United States is a party. EPA
water modeling used to assess exposure Intermediate-term aggregate exposure may establish a tolerance that is
to hexythiazox in drinking water. EPA takes into account intermediate-term different from a Codex MRL; however,
used similarly conservative assumptions residential exposure plus chronic FFDCA section 408(b)(4) requires that
to assess postapplication exposure of exposure to food and water (considered EPA explain the reasons for departing
children as well as incidental oral to be a background exposure level). from the Codex level.
exposure of toddlers. These assessments Hexythiazox is currently registered for The Codex has not established a MRL
will not underestimate the exposure and uses that could result in intermediate- for hexythiazox in/on wheat, therefore,
tkelley on DSK3SPTVN1PROD with RULES

risks posed by hexythiazox. term residential exposure, and the there are no harmonization issues
Agency has determined that it is associated with this action.
E. Aggregate Risks and Determination of appropriate to aggregate chronic
Safety exposure through food and water with V. Conclusion
EPA determines whether acute and intermediate-term residential exposures Therefore, tolerances are established
chronic dietary pesticide exposures are to hexythiazox. for residues of hexythiazox and its

VerDate Sep<11>2014 20:18 Aug 13, 2015 Jkt 235001 PO 00000 Frm 00074 Fmt 4700 Sfmt 4700 E:\FR\FM\14AUR1.SGM 14AUR1

Federal Register / Vol. 80, No. 157 / Friday, August 14, 2015 / Rules and Regulations 48757

metabolites containing the (4- to this action. In addition, this action ENVIRONMENTAL PROTECTION
chlorophenyl)-4-methyl-2-oxo-3- does not impose any enforceable duty or AGENCY
thiazolidine moiety, as petitioned. contain any unfunded mandate as
described under Title II of the Unfunded 40 CFR Part 300
VI. Statutory and Executive Order
Mandates Reform Act (UMRA) (2 U.S.C. [EPA–HQ–SFUND–1990–0010; FRL–9932–
Reviews
1501 et seq.). 37-Region 4]
This action establishes tolerances This action does not involve any
under FFDCA section 408(d) in technical standards that would require National Oil and Hazardous
response to a petition submitted to the Agency consideration of voluntary Substances Pollution Contingency
Agency. The Office of Management and consensus standards pursuant to section Plan; National Priorities List: Deletion
Budget (OMB) has exempted these types 12(d) of the National Technology of the Redwing Carriers, Inc.
of actions from review under Executive Transfer and Advancement Act (Saraland)
Order 12866, entitled ‘‘Regulatory (NTTAA) (15 U.S.C. 272 note).
Planning and Review’’ (58 FR 51735, AGENCY: Environmental Protection
October 4, 1993). Because this action VII. Congressional Review Act Agency (EPA).
has been exempted from review under Pursuant to the Congressional Review ACTION: Direct final rule.
Executive Order 12866, this action is Act (5 U.S.C. 801 et seq.), EPA will
not subject to Executive Order 13211, submit a report containing this rule and SUMMARY: The Environmental Protection
entitled ‘‘Actions Concerning other required information to the U.S. Agency (EPA) Region 4 is publishing
Regulations That Significantly Affect Senate, the U.S. House of this direct final Notice of Deletion for
Energy Supply, Distribution, or Use’’ (66 Representatives, and the Comptroller the Redwing Carriers, Inc. (Saraland)
FR 28355, May 22, 2001) or Executive General of the United States prior to Superfund Site (Site), located in
Order 13045, entitled ‘‘Protection of publication of the rule in the Federal Saraland, Mobile County, Alabama,
Children From Environmental Health Register. This action is not a ‘‘major from the National Priorities List (NPL).
Risks and Safety Risks’’ (62 FR 19885, rule’’ as defined by 5 U.S.C. 804(2). The NPL, promulgated pursuant to
April 23, 1997). This action does not Section 105 of the Comprehensive
contain any information collections List of Subjects in 40 CFR Part 180 Environmental Response,
subject to OMB approval under the Environmental protection, Compensation, and Liability Act
Paperwork Reduction Act (PRA) (44 Administrative practice and procedure, (CERCLA) of 1980, as amended, is an
U.S.C. 3501 et seq.), nor does it require Agricultural commodities, Pesticides appendix of the National Oil and
any special considerations under and pests, Reporting and recordkeeping Hazardous Substances Pollution
Executive Order 12898, entitled requirements. Contingency Plan (NCP). This direct
‘‘Federal Actions To Address final deletion is being published by the
Dated: August 6, 2015.
Environmental Justice in Minority EPA with the concurrence of the State
Susan Lewis,
Populations and Low-Income of Alabama, through the Alabama
Director, Registration Division, Office of Department of Environmental
Populations’’ (59 FR 7629, February 16, Pesticide Programs.
1994). Management (ADEM), because the EPA
Since tolerances and exemptions that Therefore, 40 CFR chapter I is has determined that all appropriate
are established on the basis of a petition amended as follows: response actions under CERCLA have
under FFDCA section 408(d), such as been completed. However, this deletion
the tolerance in this final rule, do not PART 180—[AMENDED] does not preclude future actions under
require the issuance of a proposed rule, ■ 1. The authority citation for part 180
Superfund.
the requirements of the Regulatory continues to read as follows: DATES: This direct final deletion is
Flexibility Act (RFA) (5 U.S.C. 601 et effective September 28, 2015 unless the
seq.), do not apply. Authority: 21 U.S.C. 321(q), 346a and 371.
EPA receives adverse comments by
This action directly regulates growers, ■ 2. In § 180.448, add alphabetically the September 14, 2015. If adverse
food processors, food handlers, and food following commodities to the table in comments are received, the EPA will
retailers, not States or tribes, nor does paragraph (c) to read as follows: publish a timely withdrawal of the
this action alter the relationships or direct final deletion in the Federal
distribution of power and § 180.448 Hexythiazox; tolerances for
residues. Register informing the public that the
responsibilities established by Congress deletion will not take effect.
in the preemption provisions of FFDCA * * * * *
(c) * * * ADDRESSES: Submit your comments,
section 408(n)(4). As such, the Agency identified by Docket ID No., EPA–HQ–
has determined that this action will not SFUND–1990–0010, by one of the
Parts per
have a substantial direct effect on States Commodity million following methods:
or tribal governments, on the • www.regulations.gov Follow the on-
relationship between the national line instructions for submitting
government and the States or tribal * * * * * comments.
Wheat, forage (EPA Region
governments, or on the distribution of • Email: johnston.shelby@epa.gov
11 only) ............................. 6.0
power and responsibilities among the
Wheat, hay (EPA Region 11
• Fax: (404) 562–8896, Attention:
various levels of government or between
only) .................................. 30 Shelby Johnston.
the Federal Government and Indian Wheat, grain (EPA Region • Mail: Shelby Johnston, Remedial
tribes. Thus, the Agency has determined 11 only) ............................. 0.02 Project Manager, Superfund Restoration
tkelley on DSK3SPTVN1PROD with RULES

that Executive Order 13132, entitled Wheat, straw (EPA Region and Sustainability Branch, Superfund
‘‘Federalism’’ (64 FR 43255, August 10, 11 only) ............................. 8.0 Division, U.S. Environmental Protection
1999) and Executive Order 13175, Agency, Region 4, 61 Forsyth Street,
entitled ‘‘Consultation and Coordination * * * * * SW., Atlanta, Georgia 30303–8960.
with Indian Tribal Governments’’ (65 FR [FR Doc. 2015–20012 Filed 8–13–15; 8:45 am] • Hand Delivery: U.S. Environmental
67249, November 9, 2000) do not apply BILLING CODE 6560–50–P Protection Agency, Region 4, 61 Forsyth

VerDate Sep<11>2014 20:18 Aug 13, 2015 Jkt 235001 PO 00000 Frm 00075 Fmt 4700 Sfmt 4700 E:\FR\FM\14AUR1.SGM 14AUR1

Document Created: 2018-02-23 10:58:59
Document Modified: 2018-02-23 10:58:59

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 August 14, 2015. Objections and requests for hearings must be received on or before October 13, 2015, 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		Susan Lewis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone
FR Citation		80 FR 48753
CFR Associated		Environmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements