Hexythiazox; Pesticide Tolerances, 10547-10553 [2017-02481]
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[FR Doc. 2017–02955 Filed 2–13–17; 8:45 am]
BILLING CODE 4410–14–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2015–0795, EPA–HQ–OPP–
2015–0796 and EPA–HQ–OPP–2015–0797;
FRL–9957–22]
Hexythiazox; Pesticide Tolerances
Congressional Review Act
■
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Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes
tolerances for residues of the ovicide/
miticide hexythiazox in or on beet,
sugar, root, and beet, sugar, dried pulp
and establishes tolerances associated
with regional registrations for residues
on Bermuda grass, forage and Bermuda
grass, hay. This regulation also modifies
the existing tolerances associated with
regional registrations in or on alfalfa,
forage; and alfalfa, hay. Gowan
Company requested these tolerances
under the Federal Food, Drug, and
Cosmetic Act (FFDCA). The regulation
also removes the existing time-limited
tolerance for residues on beet, sugar,
root because it is superseded by the new
beet, sugar, root tolerance and removes
the tolerance for residues ‘‘Fruit, citrus
group 10’’ of 0.35 ppm because it is
superseded by the existing tolerance for
‘‘Fruit, citrus group 10–10’’ of 0.6 ppm.
DATES: This regulation is effective
February 14, 2017. Objections and
requests for hearings must be received
on or before April 17, 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 dockets for this action,
identified by docket identification (ID)
numbers EPA–HQ–OPP–2015–0795,
EPA–HQ–OPP–2015–0796 and EPA–
HQ–OPP–2015–0797, are available at
https://www.regulations.gov or at the
SUMMARY:
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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 https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
Michael L. Goodis, P.E., 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 https://www.ecfr.gov/cgi-bin/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/
40tab_02.tpl.
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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
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identify docket ID numbers EPA–HQ–
OPP–2015–0795, EPA–HQ–OPP–2015–
0796 and EPA–HQ–OPP–2015–0797 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 17, 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 numbers EPA–HQ–OPP–
2015–0795, EPA–HQ–OPP–2015–0796
and EPA–HQ–OPP–2015–0797, by one
of the following methods:
• Federal eRulemaking Portal: https://
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 https://
www.epa.gov/dockets/contacts.html.
Additional instructions on
commenting or visiting the docket,
along with more information about
dockets generally, is available at https://
www.epa.gov/dockets.
II. Summary of Petitioned-For
Tolerance
In the Federal Register of March 16,
2016 (81 FR 14030) (FRL–9942–86),
EPA issued a document pursuant to
FFDCA section 408(d)(3), 21 U.S.C.
346a(d)(3), announcing the filing of
three (3) pesticide petitions (PP 5F8396,
5F8412 & 5F8413) by Gowan Company,
P.O. Box 5569, Yuma, AZ 85366–5569.
These petitions requested that 40 CFR
180.448 be amended by (1) establishing
tolerances for residues of the
hexythiazox in or on Bermuda grass,
forage at 40 parts per million (ppm) (PP
5F8412); Bermuda grass, hay at 70 ppm
(PP 5F8412); beet, sugar, dried pulp at
0.60 ppm (PP 5F8413); beet, sugar,
molasses at 0.21 ppm (PP 5F8413); beet,
sugar, roots at 0.15 ppm (PP 5F8413);
and beet, sugar, tops at 1.5 ppm
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(PP5F8413); and (2) modifying the
existing tolerances for residues in or on
alfalfa, forage from 15 ppm to 20 ppm
(PP 5F8396) and alfalfa, hay from 30
ppm to 60 ppm (PP 5F8396). These
documents referenced a summary of the
petitions prepared by Gowan Company,
the registrant, which are available in the
docket, https://www.regulations.gov.
Several comments were received in
response to the notice of filing, objecting
generally to the presence of pesticide
residues in food. Because none of the
comments provided any information for
the Agency to consider in its review of
the requested hexythiazox tolerances
and because the Agency has concluded
based on available data that the
tolerances requested meet the FFDCA
safety standard, EPA is not granting the
commenters’ requests to deny the
petition.
III. Aggregate Risk Assessment and
Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA
allows EPA to establish a tolerance (the
legal limit for a pesticide chemical
residue in or on a food) only if EPA
determines that the tolerance is ‘‘safe.’’
Section 408(b)(2)(A)(ii) of FFDCA
defines ‘‘safe’’ to mean that ‘‘there is a
reasonable certainty that no harm will
result from aggregate exposure to the
pesticide chemical residue, including
all anticipated dietary exposures and all
other exposures for which there is
reliable information.’’ This includes
exposure through drinking water and in
residential settings, but does not include
occupational exposure. Section
408(b)(2)(C) of FFDCA requires EPA to
give special consideration to exposure
of infants and children to the pesticide
chemical residue in establishing a
tolerance and to ‘‘ensure that there is a
reasonable certainty that no harm will
result to infants and children from
aggregate exposure to the pesticide
chemical residue. . . .’’
Consistent with FFDCA section
408(b)(2)(D), and the factors specified in
FFDCA section 408(b)(2)(D), EPA has
reviewed the available scientific data
and other relevant information in
support of this action. EPA has
sufficient data to assess the hazards of
and to make a determination on
aggregate exposure for 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,
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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
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’’ 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-observedadverse-effect-level (LOAEL) from the
toxicity studies can be found at https://
www.regulations.gov within the
document entitled ‘‘Hexythiazox.
Human Health Risk Assessment for
Section 3 Registration on Bermuda
Grass and Amended Registrations for
Use on Beet, sugars, Alfalfa, and
Potatoes,’’ which can be found in docket
ID numbers EPA–HQ–OPP–2015–0795,
EPA–HQ–OPP–2015–0796 and EPA–
HQ–OPP–2015–0797.
B. Toxicological Points of Departure/
Levels of Concern
Once a pesticide’s toxicological
profile is determined, EPA identifies
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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 https://
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
Exposure/scenario
Point of departure
and uncertainty/
safety factors
RfD, PAD, LOC for
risk assessment
Study and toxicological 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.
UFA = 10x ................
UFH = 10x ................
FQPA SF = 1x .........
NOAEL= 30 mg/kg/
day.
UFA = 10x ................
UFH = 10x ................
FQPA SF = 1x .........
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Incidental Oral Short-Term (1 to
30 days) and IntermediateTerm (1 to 6 months).
Dermal Short- and Intermediate-term.
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Chronic RfD = 0.025
mg/kg/day.
cPAD = 0.025 ..........
Residential LOC for
MOE = 100.
One-Year Feeding Toxicity
Study—Dogs
LOAEL = 12.5 mg/kg/day based on increased absolute and relative
adrenal
weights,
and
associated
adrenal
histopathology.
2-Generation Reproduction
Study—Rat
LOAEL = 180 mg/kg/day, based 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.
A quantitative dermal risk assessment is not necessary since no dermal hazard 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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TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR HEXYTHIAZOX FOR USE IN HUMAN HEALTH RISK
ASSESSMENT—Continued
Exposure/scenario
Point of departure
and uncertainty/
safety factors
RfD, PAD, LOC for
risk assessment
Residential LOC for
MOE = 100.
Study and toxicological effects
Inhalation Short-Term (1 to 30
days) and Intermediate-Term
(1 to 6 months).
Oral NOAEL = 30
mg/kg/day.
UFA = 10x ................
UFH = 10x ................
FQPA SF = 1x .........
2-Generation Reproduction
Study—Rat
LOAEL = 180 mg/kg/day, based 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.
Cancer (oral, dermal, and inhalation).
Classification: ‘‘Likely to be Carcinogenic to Humans.’’ A quantification of 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.
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).
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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 (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.
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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 https://www.epa.gov/
oppefed1/models/water/index.htm.
Because surface water and
groundwater estimated drinking water
concentrations (EDWCs) from the
proposed new uses on Bermuda grass
and sugar beets (ranging from 1.29 to
2.78 mg/L) do not produce EDWCs
greater than those produced from a
recent drinking water assessment
(D429192, 9/21/2015) (ranging from 3.5
to 7.3 mg/L) using the Mississippi
soybeans scenario, the Agency is relying
on the EDWCs from that previous
drinking water assessment. Based on
that assessment, the EDWCs of
hexythiazox for chronic exposures are
estimated to be 4.3 ppb for surface water
and 2.4 ppb for ground water. The
higher of these numbers was directly
entered into the dietary exposure model
for the chronic dietary risk assessment.
3. From non-dietary exposure. The
term ‘‘residential exposure’’ is used in
this document to refer to nonoccupational, non-dietary exposure
(e.g., for lawn and garden pest control,
indoor pest control, termiticides, and
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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. 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 post-application
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 https://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
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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
mechanism of toxicity and to evaluate
the cumulative effects of such
chemicals, see EPA’s Web site at https://
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)
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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 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 93% of
the cPAD for children 1 to 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 (7,700) that
greatly exceeds the LOC of 100, and is
not of concern.
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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 intermediateterm 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 intermediateterm 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.
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 analytical enforcement
methodology, high performance liquid
chromatography method with UV
detection (HPLC/UV), is available to
enforce the tolerance expression for
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.
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
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Federal Register / Vol. 82, No. 29 / Tuesday, February 14, 2017 / Rules and Regulations
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 for alfalfa, forage and
hay; and beet, sugar roots and top.
sradovich on DSK3GMQ082PROD with RULES
C. Revisions to Petitioned-For
Tolerances
The petitioner requested tolerances
for beet, sugar, molasses and beet, sugar,
dried pulp based on the raw agricultural
commodity (RAC) tolerance level
instead of the HAFT (Highest Average
Field Trial). Using the HAFT to
determine the tolerance for these
processed commodities, EPA
determined that residues in the
molasses would be covered by the
tolerance on the beet, sugar, root;
therefore, a separate molasses tolerance
is not required. Using the HAFT for
beet, sugar, dried pulp, EPA determined
that the tolerance should be reduced to
0.30 ppm. Beet, sugar, tops are no longer
considered a major livestock food
commodity for regulatory purposes;
therefore, a tolerance is not required for
beet, sugar, tops.
V. Conclusion
Therefore, tolerances are established
for residues of the ovicide/miticide
hexythiazox and its metabolites
containing the (4-chlorophenyl)-4methyl-2-oxo-3-thiazolidine moiety in
or on beet, sugar, root at 0.15 ppm and
beet, sugar, dried pulp at 0.30 ppm.
Tolerances associated with regional
registrations are established for
Bermuda grass, forage (EPA Regions 9–
10 only) at 40 parts per million (ppm)
and Bermuda grass, hay (EPA Regions
9–10 only) at 70 ppm. Also, existing
tolerances are modified for residues in
or on Alfalfa, forage (EPA Regions 7–11
only) at 20 ppm and Alfalfa, hay (EPA
Regions 7–11 only) at 60 ppm.
Because the new tolerance for beet,
sugar, root (in 40 CFR 180.448(a))
supersedes the existing time-limited
tolerance for beet, sugar, root (in 40 CFR
180.448(b)), the Agency is removing the
time-limited tolerance.
In addition, in the previous
rulemaking establishing hexythiazox
tolerances, EPA instructed the Federal
Register staff to revise the existing entry
in the table in paragraph (c) for ‘‘Fruit,
citrus group 10 (CA, AZ, TX only)’’ at
0.35 ppm to ‘‘Fruit, citrus group 10–10
(CA, AZ, TX only)’’ at 0.6 ppm. (April
6, 2016, 81 FR 19891). Instead of
revising the existing entry, a separate
entry was created for ‘‘Fruit, citrus
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15:57 Feb 13, 2017
Jkt 241001
group 10–10 (CA, AZ, TX only).’’ The
result is that the table in paragraph (c)
now contains two overlapping entries:
‘‘Fruit, citrus group 10 (CA, AZ, TX
only)’’ of 0.35 ppm and an entry for
‘‘Fruit, citrus group 10–10 (CA, AZ, TX
only)’’ of 0.6 ppm. Because ‘‘Fruit,
citrus group 10 (CA, AZ, TX only)’’ is
superseded by ‘‘Fruit, citrus group 10–
10 (CA, AZ, TX only),’’ EPA is removing
‘‘Fruit, citrus group 10 (CA, AZ, TX
only)’’ as a housekeeping measure.
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
PO 00000
Frm 00012
Fmt 4700
Sfmt 4700
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: January 10, 2017.
Michael Goodis,
Acting Director, Registration Division, Office
of Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. In § 180.448:
i. Add alphabetically the entries for
‘‘Beet, sugar, dried pulp’’ and ‘‘Beet,
sugar, root’’ to the table in paragraph (a).
■ ii. Revise paragraph (b).
■ iii. Revise the two entries for ‘‘Alfalfa’’
in the table in paragraph (c);
■ iv. Add alphabetically the entries for
‘‘Bermuda grass, forage (EPA Regions 9–
10 only)’’ and ‘‘Bermuda grass, hay
(EPA Regions 9–10 only)’’ to the table in
paragraph (c); and
■ v. Remove the entry for ‘‘Fruit, citrus
group 10 (CA, AZ, TX only)’’ in the
table in paragraph (c).
■
■
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Federal Register / Vol. 82, No. 29 / Tuesday, February 14, 2017 / Rules and Regulations
eastern zone of the Gulf of Mexico (Gulf)
exclusive economic zone (EEZ) using
run-around gillnet gear. NMFS has
§ 180.448 Hexythiazox; tolerances for
determined that the commercial annual
residues.
catch limit (ACL, equivalent to the
(a) * * *
commercial quota) for king mackerel
using run-around gillnet gear in the
Parts
Florida west coast southern subzone of
Commodity
per
million the Gulf EEZ will be reached by
February 10, 2017. Therefore, NMFS
closes the Florida west coast southern
*
*
*
*
*
subzone to commercial king mackerel
Beet, sugar, dried pulp .....................
0.30 fishing using run-around gillnet gear in
Beet, sugar, root ...............................
0.15 the Gulf EEZ. This closure is necessary
to protect the Gulf king mackerel
*
*
*
*
*
resource.
(b) Section 18 emergency exemptions. DATES: The closure is effective from
12:01 p.m., eastern standard time,
[Reserved]
February 10, 2017, until 6 a.m., eastern
(c) * * *
standard time, January 16, 2018.
Parts
FOR FURTHER INFORMATION CONTACT:
Commodity
per
Kelli O’Donnell, NMFS Southeast
million Regional Office, telephone: 727–824–
5305, email: kelli.odonnell@noaa.gov.
Alfalfa, forage (EPA Regions 7–11
only) ..............................................
20 SUPPLEMENTARY INFORMATION: The
fishery for coastal migratory pelagic fish
Alfalfa, hay (EPA Regions 7–11
only) ..............................................
60 includes king mackerel, Spanish
mackerel, and cobia, and is managed
*
*
*
*
*
under the Fishery Management Plan for
Bermuda grass, forage (EPA Rethe Coastal Migratory Pelagic Resources
gions 9–10 only) ...........................
40
of the Gulf of Mexico and Atlantic
Bermuda grass, hay (EPA Regions
9–10 only) .....................................
70 Region (FMP). The FMP was prepared
by the Gulf of Mexico and South
Atlantic Fishery Management Councils
*
*
*
*
*
and is implemented by NMFS under the
authority of the Magnuson-Stevens
*
*
*
*
*
Fishery Conservation and Management
[FR Doc. 2017–02481 Filed 2–13–17; 8:45 am]
Act (Magnuson-Stevens Act) by
BILLING CODE 6560–50–P
regulations at 50 CFR part 622.
The Florida west coast subzone of the
Gulf eastern zone for Gulf migratory
DEPARTMENT OF COMMERCE
group king mackerel (Gulf king
mackerel) is divided into northern and
National Oceanic and Atmospheric
southern subzones, each with separate
Administration
commercial quotas. From November 1
through March 31, the southern subzone
50 CFR Part 622
encompasses an area of the EEZ south
[Docket No. 101206604–1758–02]
of a line extending due west of the Lee
and Collier County, Florida, boundary
RIN 0648–XF151
on the Florida west coast, and south of
a line extending due east of the Monroe
Fisheries of the Caribbean, Gulf of
and Miami-Dade County, Florida,
Mexico, and South Atlantic; Coastal
boundary on the Florida east coast,
Migratory Pelagic Resources of the
which includes the EEZ off Collier and
Gulf of Mexico and Atlantic Region;
Monroe Counties, Florida. From April 1
2017 Commercial Run-Around Gillnet
through October 31, the southern
Closure
subzone is reduced to the EEZ off
AGENCY: National Marine Fisheries
Collier County, and the EEZ off Monroe
Service (NMFS), National Oceanic and
County becomes part of the Atlantic
Atmospheric Administration (NOAA),
migratory group area (50 CFR
Commerce.
622.369(a)(1)(ii)(A)(2)).
The commercial quota for Gulf king
ACTION: Temporary rule; closure.
mackerel in the Florida west coast
SUMMARY: NMFS implements an
southern subzone is 551,448 lb (250,133
accountability measure (AM) through
kg) for vessels using run-around gillnet
this temporary rule for commercial
gear (50 CFR 622.384(b)(1)(i)(B)(1)), for
harvest of king mackerel in the Florida
the current fishing year, July 1, 2016,
west coast southern subzone of the
through June 30, 2017.
sradovich on DSK3GMQ082PROD with RULES
The additions and revisions read as
follows:
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15:57 Feb 13, 2017
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10553
Regulations at 50 CFR 622.8(b) and
622.388(a)(1) require NMFS to close any
segment of the king mackerel
commercial sector when its quota has
been reached, or is projected to be
reached, by filing a notification with the
Office of the Federal Register. NMFS has
determined that the Gulf king mackerel
commercial quota of 551,448 lb (250,133
kg) for vessels using run-around gillnet
gear in the Florida west coast southern
subzone will be reached by February 10,
2017. Accordingly, commercial fishing
using such gear in the Florida west coast
southern subzone is closed at 12:01
p.m., eastern standard time, February
10, 2017, until 6 a.m., eastern standard
time, January 16, 2018, the beginning of
the next fishing season, i.e., the day after
the 2018 Martin Luther King, Jr. Federal
holiday. Accordingly, the vessel
operator that has been issued a Federal
commercial permit to harvest Gulf king
mackerel using run-around gillnet gear
in the Florida west coast southern
subzone must have landed ashore and
bartered, traded, or sold such king
mackerel prior to 12:01 p.m., eastern
standard time, February 10, 2017.
Persons aboard a vessel for which a
commercial permit for king mackerel
has been issued, except persons who
also possess a king mackerel gillnet
permit, may fish for or retain Gulf king
mackerel harvested using hook-and-line
gear in the Florida west coast southern
subzone unless the commercial quota
for hook-and-line gear has been met and
the hook-and-line segment of the
commercial sector has been closed. A
person aboard a vessel that has a valid
charter vessel/headboat permit for
coastal migratory pelagic fish may
continue to retain king mackerel in or
from closed zones or subzones under
the bag and possession limits set forth
in 50 CFR 622.382(a)(1)(ii) and (a)(2),
provided the vessel is operating as a
charter vessel or headboat. A charter
vessel or headboat that also has a
commercial king mackerel permit is
considered to be operating as a charter
vessel or headboat when it carries a
passenger who pays a fee or when there
are more than three persons aboard,
including operator and crew.
During the closure, king mackerel
harvested using run-around gillnet gear
in the Florida west coast southern
subzone may not be purchased or sold.
This prohibition does not apply to king
mackerel harvested using run-around
gillnet gear in the Florida west coast
southern subzone that were harvested,
landed ashore, and sold prior to the
closure and were held in cold storage by
a dealer or processor.
E:\FR\FM\14FER1.SGM
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]]>Agencies
[Federal Register Volume 82, Number 29 (Tuesday, February 14, 2017)]
[Rules and Regulations]
[Pages 10547-10553]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-02481]
=======================================================================
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2015-0795, EPA-HQ-OPP-2015-0796 and EPA-HQ-OPP-2015-0797;
FRL-9957-22]
Hexythiazox; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes tolerances for residues of the
ovicide/miticide hexythiazox in or on beet, sugar, root, and beet,
sugar, dried pulp and establishes tolerances associated with regional
registrations for residues on Bermuda grass, forage and Bermuda grass,
hay. This regulation also modifies the existing tolerances associated
with regional registrations in or on alfalfa, forage; and alfalfa, hay.
Gowan Company requested these tolerances under the Federal Food, Drug,
and Cosmetic Act (FFDCA). The regulation also removes the existing
time-limited tolerance for residues on beet, sugar, root because it is
superseded by the new beet, sugar, root tolerance and removes the
tolerance for residues ``Fruit, citrus group 10'' of 0.35 ppm because
it is superseded by the existing tolerance for ``Fruit, citrus group
10-10'' of 0.6 ppm.
DATES: This regulation is effective February 14, 2017. Objections and
requests for hearings must be received on or before April 17, 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 dockets for this action, identified by docket
identification (ID) numbers EPA-HQ-OPP-2015-0795, EPA-HQ-OPP-2015-0796
and EPA-HQ-OPP-2015-0797, are available at https://www.regulations.gov
or at the
[[Page 10548]]
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 https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Michael L. Goodis, P.E., 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 https://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 numbers EPA-HQ-OPP-2015-0795, EPA-HQ-OPP-2015-0796 and EPA-
HQ-OPP-2015-0797 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
17, 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 numbers EPA-HQ-OPP-2015-0795, EPA-HQ-
OPP-2015-0796 and EPA-HQ-OPP-2015-0797, by one of the following
methods:
Federal eRulemaking Portal: https://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 https://www.epa.gov/dockets/contacts.html.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at https://www.epa.gov/dockets.
II. Summary of Petitioned-For Tolerance
In the Federal Register of March 16, 2016 (81 FR 14030) (FRL-9942-
86), EPA issued a document pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of three (3) pesticide
petitions (PP 5F8396, 5F8412 & 5F8413) by Gowan Company, P.O. Box 5569,
Yuma, AZ 85366-5569. These petitions requested that 40 CFR 180.448 be
amended by (1) establishing tolerances for residues of the hexythiazox
in or on Bermuda grass, forage at 40 parts per million (ppm) (PP
5F8412); Bermuda grass, hay at 70 ppm (PP 5F8412); beet, sugar, dried
pulp at 0.60 ppm (PP 5F8413); beet, sugar, molasses at 0.21 ppm (PP
5F8413); beet, sugar, roots at 0.15 ppm (PP 5F8413); and beet, sugar,
tops at 1.5 ppm (PP5F8413); and (2) modifying the existing tolerances
for residues in or on alfalfa, forage from 15 ppm to 20 ppm (PP 5F8396)
and alfalfa, hay from 30 ppm to 60 ppm (PP 5F8396). These documents
referenced a summary of the petitions prepared by Gowan Company, the
registrant, which are available in the docket, https://www.regulations.gov. Several comments were received in response to the
notice of filing, objecting generally to the presence of pesticide
residues in food. Because none of the comments provided any information
for the Agency to consider in its review of the requested hexythiazox
tolerances and because the Agency has concluded based on available data
that the tolerances requested meet the FFDCA safety standard, EPA is
not granting the commenters' requests to deny the petition.
III. Aggregate Risk Assessment and Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
.''
Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for 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,
[[Page 10549]]
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 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'' 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 https://www.regulations.gov within the document entitled ``Hexythiazox. Human
Health Risk Assessment for Section 3 Registration on Bermuda Grass and
Amended Registrations for Use on Beet, sugars, Alfalfa, and Potatoes,''
which can be found in docket ID numbers EPA-HQ-OPP-2015-0795, EPA-HQ-
OPP-2015-0796 and EPA-HQ-OPP-2015-0797.
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 https://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
Exposure/scenario and uncertainty/ RfD, PAD, LOC for Study and toxicological effects
safety factors risk assessment
----------------------------------------------------------------------------------------------------------------
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 One-Year Feeding Toxicity
UFA = 10x........... mg/kg/day. Study--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
30 days) and Intermediate-Term UFA = 10x........... MOE = 100. Study--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.
------------------------------------------------------------------------------
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.
------------------------------------------------------------------------------
[[Page 10550]]
Inhalation Short-Term (1 to 30 Oral NOAEL = 30 mg/ Residential LOC for 2-Generation Reproduction
days) and Intermediate-Term (1 kg/day. MOE = 100. Study--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.
------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------
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 (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 https://www.epa.gov/oppefed1/models/water/index.htm.
Because surface water and groundwater estimated drinking water
concentrations (EDWCs) from the proposed new uses on Bermuda grass and
sugar beets (ranging from 1.29 to 2.78 [mu]g/L) do not produce EDWCs
greater than those produced from a recent drinking water assessment
(D429192, 9/21/2015) (ranging from 3.5 to 7.3 [mu]g/L) using the
Mississippi soybeans scenario, the Agency is relying on the EDWCs from
that previous drinking water assessment. Based on that assessment, the
EDWCs of hexythiazox for chronic exposures are estimated to be 4.3 ppb
for surface water and 2.4 ppb for ground water. The higher of these
numbers was directly entered into the dietary exposure model for the
chronic dietary risk assessment.
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.
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 post-application
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 https://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
[[Page 10551]]
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 mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see EPA's Web site at https://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
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 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 93% of the cPAD for
children 1 to 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
(7,700) 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.
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 analytical enforcement methodology, high performance
liquid chromatography method with UV detection (HPLC/UV), is available
to enforce the tolerance expression for 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.
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
[[Page 10552]]
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 for alfalfa,
forage and hay; and beet, sugar roots and top.
C. Revisions to Petitioned-For Tolerances
The petitioner requested tolerances for beet, sugar, molasses and
beet, sugar, dried pulp based on the raw agricultural commodity (RAC)
tolerance level instead of the HAFT (Highest Average Field Trial).
Using the HAFT to determine the tolerance for these processed
commodities, EPA determined that residues in the molasses would be
covered by the tolerance on the beet, sugar, root; therefore, a
separate molasses tolerance is not required. Using the HAFT for beet,
sugar, dried pulp, EPA determined that the tolerance should be reduced
to 0.30 ppm. Beet, sugar, tops are no longer considered a major
livestock food commodity for regulatory purposes; therefore, a
tolerance is not required for beet, sugar, tops.
V. Conclusion
Therefore, tolerances are established for residues of the ovicide/
miticide hexythiazox and its metabolites containing the (4-
chlorophenyl)-4-methyl-2-oxo-3-thiazolidine moiety in or on beet,
sugar, root at 0.15 ppm and beet, sugar, dried pulp at 0.30 ppm.
Tolerances associated with regional registrations are established for
Bermuda grass, forage (EPA Regions 9-10 only) at 40 parts per million
(ppm) and Bermuda grass, hay (EPA Regions 9-10 only) at 70 ppm. Also,
existing tolerances are modified for residues in or on Alfalfa, forage
(EPA Regions 7-11 only) at 20 ppm and Alfalfa, hay (EPA Regions 7-11
only) at 60 ppm.
Because the new tolerance for beet, sugar, root (in 40 CFR
180.448(a)) supersedes the existing time-limited tolerance for beet,
sugar, root (in 40 CFR 180.448(b)), the Agency is removing the time-
limited tolerance.
In addition, in the previous rulemaking establishing hexythiazox
tolerances, EPA instructed the Federal Register staff to revise the
existing entry in the table in paragraph (c) for ``Fruit, citrus group
10 (CA, AZ, TX only)'' at 0.35 ppm to ``Fruit, citrus group 10-10 (CA,
AZ, TX only)'' at 0.6 ppm. (April 6, 2016, 81 FR 19891). Instead of
revising the existing entry, a separate entry was created for ``Fruit,
citrus group 10-10 (CA, AZ, TX only).'' The result is that the table in
paragraph (c) now contains two overlapping entries: ``Fruit, citrus
group 10 (CA, AZ, TX only)'' of 0.35 ppm and an entry for ``Fruit,
citrus group 10-10 (CA, AZ, TX only)'' of 0.6 ppm. Because ``Fruit,
citrus group 10 (CA, AZ, TX only)'' is superseded by ``Fruit, citrus
group 10-10 (CA, AZ, TX only),'' EPA is removing ``Fruit, citrus group
10 (CA, AZ, TX only)'' as a housekeeping measure.
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: January 10, 2017.
Michael Goodis,
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. In Sec. 180.448:
0
i. Add alphabetically the entries for ``Beet, sugar, dried pulp'' and
``Beet, sugar, root'' to the table in paragraph (a).
0
ii. Revise paragraph (b).
0
iii. Revise the two entries for ``Alfalfa'' in the table in paragraph
(c);
0
iv. Add alphabetically the entries for ``Bermuda grass, forage (EPA
Regions 9-10 only)'' and ``Bermuda grass, hay (EPA Regions 9-10 only)''
to the table in paragraph (c); and
0
v. Remove the entry for ``Fruit, citrus group 10 (CA, AZ, TX only)'' in
the table in paragraph (c).
[[Page 10553]]
The additions and revisions read as follows:
Sec. 180.448 Hexythiazox; tolerances for residues.
(a) * * *
------------------------------------------------------------------------
Parts
Commodity per
million
------------------------------------------------------------------------
* * * * *
Beet, sugar, dried pulp........................................ 0.30
Beet, sugar, root.............................................. 0.15
* * * * *
------------------------------------------------------------------------
(b) Section 18 emergency exemptions. [Reserved]
(c) * * *
------------------------------------------------------------------------
Parts
Commodity per
million
------------------------------------------------------------------------
Alfalfa, forage (EPA Regions 7-11 only)........................ 20
Alfalfa, hay (EPA Regions 7-11 only)........................... 60
* * * * *
Bermuda grass, forage (EPA Regions 9-10 only).................. 40
Bermuda grass, hay (EPA Regions 9-10 only)..................... 70
* * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. 2017-02481 Filed 2-13-17; 8:45 am]
BILLING CODE 6560-50-P
