Hexythiazox; Pesticide Tolerances, 50084-50089 [2017-23439]
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Federal Register / Vol. 82, No. 208 / Monday, October 30, 2017 / Rules and Regulations
B. Impact on Small Entities
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Under section 213(a) of the Small
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Fairness Act of 1996 (Pub. L. 104–121),
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C. Collection of Information
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This rule calls for no new collection
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A rule has implications for federalism
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between the national government and
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Also, this rule does not have tribal
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We have analyzed this rule under
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which guides the Coast Guard in
complying with the National
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(NEPA) (42 U.S.C. 4321–4370f), and
have made a determination that this
action is one of a category of actions
which do not individually or
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the human environment. This rule
simply promulgates the operating
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drawbridges. This action is categorically
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INFORMATION CONTACT section to
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coordinate protest activities so that your
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jeopardizing the safety or security of
people, places or vessels.
List of Subjects in 33 CFR Part 117
Bridges.
For the reasons discussed in the
preamble, the Coast Guard amends 33
CFR part 117 as follows:
PART 117—DRAWBRIDGE
OPERATION REGULATIONS
1. The authority citation for part 117
continues to read as follows:
■
Authority: 33 U.S.C. 499; 33 CFR 1.05–1;
Department of Homeland Security Delegation
No. 0170.1.
2. Revise § 117.243(b) to read as
follows:
■
§ 117.243
Nanticoke River.
*
*
*
*
*
(b) The draw of the SR 13 Bridge, mile
39.6, in Seaford shall:
(1) Open on signal, except from 6 p.m.
to 8 a.m., from April 1 through October
31; from November 1 through March 31,
Monday to Friday and on Saturday and
Sunday from 3:30 p.m. to 7:30 a.m., if
at least four hours notice is given.
(2) Open on signal, on Saturday and
Sunday, from 7:31 a.m. through 3:29
p.m., from November 1 through March
31, if at least 24 hours notice is given.
Dated: October 10, 2017.
M.L. Austin,
Rear Admiral, U.S. Coast Guard, Commander,
Fifth Coast Guard District.
[FR Doc. 2017–23559 Filed 10–27–17; 8:45 am]
BILLING CODE 9110–04–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2017–0155; FRL–9968–12]
Hexythiazox; Pesticide Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation amends an
existing tolerance for residues of the
ovicide/miticide hexythiazox in/on hop,
dried cones, by increasing the current
tolerance from 2.0 parts per million
(ppm) to 20 ppm. Gowan Company
requested modification of this tolerance
under the Federal Food, Drug, and
Cosmetic Act (FFDCA).
DATES: This regulation is effective
October 30, 2017. Objections and
requests for hearings must be received
SUMMARY:
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on or before December 29, 2017, and
must be filed in accordance with the
instructions provided in 40 CFR part
178 (see also Unit I.C. of the
SUPPLEMENTARY INFORMATION).
ADDRESSES: The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2017–0155, is
available at https://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 https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
Michael L. Goodis, P.E., Director,
Registration Division (7505P), Office of
Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania
Ave. NW., Washington, DC 20460–0001;
main telephone number: (703) 305–
7090; email address: 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).
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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
identify docket ID number EPA–HQ–
OPP–2017–0155 in the subject line on
the first page of your submission. All
objections and requests for a hearing
must be in writing, and must be
received by the Hearing Clerk on or
before December 29, 2017. Addresses for
mail and hand delivery of objections
and hearing requests are provided in 40
CFR 178.25(b).
In addition to filing an objection or
hearing request with the Hearing Clerk
as described in 40 CFR part 178, please
submit a copy of the filing (excluding
any Confidential Business Information
(CBI)) for inclusion in the public docket.
Information not marked confidential
pursuant to 40 CFR part 2 may be
disclosed publicly by EPA without prior
notice. Submit the non-CBI copy of your
objection or hearing request, identified
by docket ID number EPA–HQ–OPP–
2017–0155, by one of the following
methods:
• Federal eRulemaking Portal: 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 June 8, 2017
(82 FR 26641) (FRL–9961–14), EPA
issued a document pursuant to the
Federal Food, Drug, and Cosmetic Act
(FFDCA) section 408(d)(3), 21 U.S.C.
346a(d)(3), announcing the filing of a
pesticide petition (PP #6F8489) by
Gowan Company, P.O. Box 5569, Yuma,
AZ 85366–5569. This petition requested
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that 40 CFR 180.448 be amended by
establishing a tolerance for residues of
hexythiazox in or on hop, dried cones
at 20 ppm. This document referenced a
summary of the petition prepared by
Gowan Company, the registrant, which
is available in the docket, https://
www.regulations.gov. No comments
were received in response to the
referenced notice of filing.
III. Aggregate Risk Assessment and
Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA
allows EPA to establish a tolerance (the
legal limit for a pesticide chemical
residue in or on a food) only if EPA
determines that the tolerance is ‘‘safe.’’
Section 408(b)(2)(A)(ii) of FFDCA
defines ‘‘safe’’ to mean that ‘‘there is a
reasonable certainty that no harm will
result from aggregate exposure to the
pesticide chemical residue, including
all anticipated dietary exposures and all
other exposures for which there is
reliable information.’’ This includes
exposure through drinking water and in
residential settings, but does not include
occupational exposure. Section
408(b)(2)(C) of FFDCA requires EPA to
give special consideration to exposure
of infants and children to the pesticide
chemical residue in establishing a
tolerance and to ‘‘ensure that there is a
reasonable certainty that no harm will
result to infants and children from
aggregate exposure to the pesticide
chemical residue. . . .’’
Consistent with FFDCA section
408(b)(2)(D), and the factors specified in
FFDCA section 408(b)(2)(D), EPA has
reviewed the available scientific data
and other relevant information in
support of this action. EPA has
sufficient data to assess the hazards of
and to make a determination on
aggregate exposure for hexythiazox
including exposure resulting from the
tolerances established by this action.
EPA’s assessment of exposures and risks
associated with hexythiazox follows.
A. Toxicological Profile
EPA has evaluated the available
toxicity data and considered its validity,
completeness, and reliability as well as
the relationship of the results of the
studies to human risk. EPA has also
considered available information
concerning the variability of the
sensitivities of major identifiable
subgroups of consumers, including
infants and children.
Hexythiazox has low acute toxicity by
the oral, dermal, and inhalation routes
of exposure. It produces mild eye
irritation and is not a skin irritant or
skin sensitizer. Hexythiazox is
associated with toxicity of the liver and
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adrenals following subchronic and
chronic exposure to dogs, rats, and
mice, with the dog being the most
sensitive species. The prenatal
developmental studies in rabbits and
rats and the two-generation
reproduction study in rats showed no
indication of increased susceptibility to
in utero or postnatal exposure to
hexythiazox. Reproductive toxicity was
not observed. There is no concern for
immunotoxicity or neurotoxicity
following exposure to hexythiazox. The
toxicology database for hexythiazox
does not show any evidence of
treatment-related effects on the immune
system.
Hexythiazox is classified as ‘‘Likely to
be Carcinogenic to Humans’’ based on a
treatment-related increase in benign and
malignant liver tumors in female mice
and the presence of mammary gland
tumors (fibroadenomas) in male rats;
however, the evidence as a whole was
not strong enough to warrant the use of
a linear low dose extrapolation model
applied to the animal data (Q1*) for a
quantitative estimation of human risk
because the common liver tumors
(benign and malignant) were only
observed in high-dose female mice, and
benign mammary gland tumors were
only observed in high-dose male rats.
Since the effects seen in the study that
serves as the basis for the chronic
reference dose (cRfD) occurred at doses
substantially below the lowest dose that
induced tumors (and there is no
mutagenic concern for hexythiazox), the
cRfD is considered protective of all
chronic effects, including potential
carcinogenicity.
Specific information on the studies
received and the nature of the adverse
effects caused by hexythiazox as well as
the no-observed-adverse-effect-level
(NOAEL) and the lowest-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
Amended Use on Hops,’’ dated
September 5, 2017, which can be found
in docket ID number EPA–HQ–OPP–
2017–0155.
B. Toxicological Points of Departure/
Levels of Concern
Once a pesticide’s toxicological
profile is determined, EPA identifies
toxicological points of departure (POD)
and levels of concern to use in
evaluating the risk posed by human
exposure to the pesticide. For hazards
that have a threshold below which there
is no appreciable risk, the toxicological
POD is used as the basis for derivation
of reference values for risk assessment.
PODs are developed based on a careful
analysis of the doses in each
toxicological study to determine the
dose at which no adverse effects are
observed (the NOAEL) and the lowest
dose at which adverse effects of concern
are identified (the LOAEL). Uncertainty/
safety factors are used in conjunction
with the POD to calculate a safe
exposure level—generally referred to as
a population-adjusted dose (PAD) or a
reference dose (RfD)—and a safe margin
of exposure (MOE). For non-threshold
risks, the Agency assumes that any
amount of exposure will lead to some
degree of risk. Thus, the Agency
estimates risk in terms of the probability
of an occurrence of the adverse effect
expected in a lifetime. For more
information on the general principles
EPA uses in risk characterization and a
complete description of the risk
assessment process, see https://
www.epa.gov/pesticides/factsheets/
riskassess.htm. A summary of the
toxicological endpoints for hexythiazox
used for human risk assessment is
shown in the Table of this unit.
TABLE—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR HEXYTHIAZOX FOR USE IN HUMAN HEALTH RISK
ASSESSMENT
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
Incidental Oral Short-Term (1 to
30 days) and IntermediateTerm (1 to 6 months).
Chronic RfD = 0.025
mg/kg/day.
cPAD = 0.025
One-Year Feeding Toxicity Study—Dogs.
LOAEL = 12.5 mg/kg/day based on increased absolute and relative
adrenal
weights,
and
associated
adrenal
histopathology.
Residential LOC for
MOE = 100.
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 postnatal exposure to hexythiazox.
Inhalation Short-Term (1 to 30
days) and Intermediate-Term
(1 to 6 months).
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Dermal Short- and Intermediate-term.
Oral NOAEL= 30
mg/kg/day.
UFA = 10x
UFH = 10x
FQPA SF = 1x
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Residential LOC for
MOE = 100.
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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.
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50087
TABLE—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR HEXYTHIAZOX FOR USE IN HUMAN HEALTH RISK
ASSESSMENT—Continued
Exposure/scenario
Cancer (oral, dermal, and inhalation).
Point of departure
and uncertainty/
safety factors
RfD, PAD, LOC for
risk assessment
Study and toxicological effects
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 toxic effects attributable to
a single dose of hexythiazox were
observed in the toxicology database;
therefore, a quantitative acute dietary
exposure and risk assessment is
unnecessary.
ii. Chronic exposure. In conducting
the chronic dietary (food and drinking
water) exposure assessment, EPA used
the Dietary Exposure Evaluation Model
(DEEM–FCID), Version 3.16, which uses
food consumption data from the U.S.
Department of Agriculture’s National
Health and Nutrition Examination
Survey, What We Eat in America
(NHANES/WWEIA) from 2003–2008. As
to residue levels in food, EPA used
tolerance-level residues, assumed 100
percent crop treated (PCT), and
incorporated DEEM 7.81 default
processing factors when processing data
were not available.
iii. Cancer. Based on the data
summarized in Unit III.A., EPA has
concluded that a nonlinear RfD
approach is appropriate for assessing
cancer risk to hexythiazox. Cancer risk
was assessed using the same exposure
estimates as discussed in Unit III.C.1.ii.,
Chronic exposure.
iv. Anticipated residue and percent
crop treated (PCT) information. EPA did
not use anticipated residue and/or PCT
information in the dietary assessment
for hexythiazox. Tolerance-level
residues and/or 100 PCT were assumed
for all food commodities.
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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.
Surface water and groundwater
estimated drinking water concentrations
(EDWCs) do not result in any change to
the existing EDWCs determined from a
recent drinking water assessment
derived on hops. Specifically, since
hops is already a registered use that was
recently assessed during registration
review, no new drinking water scenarios
were identified with this proposed
increase in application rates that would
require a new drinking water
assessment to be conducted. In fact, the
highest EDWCs associated with all uses
of hexythiazox continue to be from use
on sorghum in the Western U.S., using
the Pesticide Root Zone Model (PRZM)
surface water modeling scenario.
Furthermore, based on the Agency’s
previous assessment, the EDWCs of
hexythiazox for chronic exposures are
estimated to be 4.3 parts per billion
(ppb) for surface water and 2.4 ppb for
ground water (DP 433290, 5/9/2016; DP
404023, 1/17/2012), and the higher of
these values was used in the dietary
exposure model to assess chronic
dietary risk.
3. From non-dietary exposure. The
term ‘‘residential exposure’’ is used in
this document to refer to nonoccupational, 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.
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EPA assessed residential exposure
using the following assumptions:
Residential handler exposures are
expected to be short-term (1 to 30 days)
via either the dermal or inhalation
routes of exposures. Since a quantitative
dermal risk assessment is not needed for
hexythiazox, handler MOEs were
calculated for the inhalation route of
exposure only. EPA uses the term ‘‘postapplication’’ to describe exposure to
individuals that occur as a result of
being in an environment that has been
previously treated with a pesticide.
There is potential for post-application
for individuals exposed as a result of
being in an environment that has been
previously treated with hexythiazox.
Adult residential post-application
dermal exposures were not assessed
since no dermal hazard was identified
for hexythiazox. The residential postapplication exposure assessment for
children included incidental oral
exposure resulting from transfer of
residues from the hand-to-mouth, object
to- mouth, and from incidental ingestion
of soil.
Further information regarding EPA
standard assumptions and generic
inputs for residential exposures may be
found at 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
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
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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.
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D. Safety Factor for Infants and
Children
1. In general. Section 408(b)(2)(C) of
FFDCA provides that EPA shall apply
an additional tenfold (10X) margin of
safety for infants and children in the
case of threshold effects to account for
prenatal and postnatal toxicity and the
completeness of the database on toxicity
and exposure unless EPA determines
based on reliable data that a different
margin of safety will be safe for infants
and children. This additional margin of
safety is commonly referred to as the
Food Quality Protection Act Safety
Factor (FQPA SF). In applying this
provision, EPA either retains the default
value of 10X, or uses a different
additional safety factor when reliable
data available to EPA support the choice
of a different factor.
2. Prenatal and postnatal sensitivity.
The prenatal and postnatal toxicology
data base indicates no increased
susceptibility of rats or rabbits to in
utero and/or postnatal exposure to
hexythiazox.
3. Conclusion. EPA has determined
that reliable data show the safety of
infants and children would be
adequately protected if the FQPA SF
were reduced to 1x. That decision is
based on the following findings:
i. The toxicity database for
hexythiazox is complete.
ii. There is no indication that
hexythiazox is a neurotoxic chemical
and there is no need for a
developmental neurotoxicity study or
additional UFs to account for
neurotoxicity.
iii. There is no evidence that
hexythiazox results in increased
susceptibility in in utero rats or rabbits
in the prenatal developmental studies or
in young rats in the 2-generation
reproduction study.
iv. There are no residual uncertainties
identified in the exposure databases.
EPA made conservative (protective)
assumptions in the ground and surface
water modeling used to assess exposure
to hexythiazox in drinking water. EPA
used similarly conservative assumptions
to assess post-application exposure of
children as well as incidental oral
exposure of toddlers. These assessments
will not underestimate the exposure and
risks posed by hexythiazox.
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13:41 Oct 27, 2017
Jkt 244001
E. Aggregate Risks and Determination of
Safety
EPA determines whether acute and
chronic dietary pesticide exposures are
safe by comparing aggregate exposure
estimates to the acute PAD (aPAD) and
chronic PAD (cPAD). For linear cancer
risks, EPA calculates the lifetime
probability of acquiring cancer given the
estimated aggregate exposure. Short-,
intermediate-, and chronic-term risks
are evaluated by comparing the
estimated aggregate food, water, and
residential exposure to the appropriate
PODs to ensure that an adequate MOE
exists.
1. Acute risk. An acute aggregate risk
assessment takes into account acute
exposure estimates from dietary
consumption of food and drinking
water. No toxic effects attributable to a
single dose of hexythiazox were
observed in the toxicology database;
therefore, a quantitative acute aggregate
risk assessment for hexythiazox is not
required.
2. Chronic risk. Using the exposure
assumptions described in this unit for
chronic exposure, EPA has concluded
that chronic exposure to hexythiazox
from food and water will utilize 93% of
the cPAD for children 1–2 years of age,
the population group receiving the
greatest exposure. Based on the
explanation in Unit III.C.3., regarding
residential use patterns, chronic
residential exposure to residues of
hexythiazox is not expected.
3. Short-term risk. Short-term
aggregate exposure takes into account
short-term residential exposure plus
chronic exposure to food and water
(considered to be a background
exposure level).
Hexythiazox is currently registered for
uses that could result in short-term
residential exposure, and the Agency
has determined that it is appropriate to
aggregate chronic exposure through food
and water with short-term residential
exposures to hexythiazox. Using the
exposure assumptions described in this
unit for short-term exposures, EPA has
concluded the combined short-term
food, drinking water, and residential
inhalation exposures result in an
aggregate MOE for adults (7,500) that
greatly exceeds the LOC of 100, and is
not of concern.
4. Intermediate-term risk.
Intermediate-term aggregate exposure
takes into account intermediate-term
residential exposure plus chronic
exposure to food and water (considered
to be a background exposure level).
Hexythiazox is currently registered for
uses that could result in intermediateterm residential exposure, and the
PO 00000
Frm 00030
Fmt 4700
Sfmt 4700
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; therefore, the Agency
concludes that aggregate exposure to
hexythiazox will not pose a cancer risk.
6. Determination of safety. Based on
these risk assessments, EPA concludes
that there is a reasonable certainty that
no harm will result to the U.S. general
population, or to infants and children
from aggregate exposure to hexythiazox
residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
An adequate High performance liquid
chromatography using ultra-violet
detection (HPLC/UV) analytical method
is available for the enforcement of
tolerances for residues of hexythiazox
and its metabolites containing the PT–
1–3 moiety in crop and livestock
commodities. This method is listed in
the U.S. EPA Index of Residue
Analytical Methods under hexythiazox
as method AMR–985–87. The limit of
quantification (LOQ) for hexythiazox
residues is 0.02 ppm.
B. International Residue Limits
In making its tolerance decisions, EPA
seeks to harmonize U.S. tolerances with
international standards whenever
possible, consistent with U.S. food
safety standards and agricultural
practices. EPA considers the
international maximum residue limits
(MRLs) established by the Codex
Alimentarius Commission (Codex), as
required by Federal Food, Drug and
Cosmetic Act (FFDCA) section 408(b)(4).
The Codex Alimentarius is a joint
United Nations Food and Agriculture
Organization/World Health
Organization food standards program,
and it is recognized as an international
food safety standards-setting
organization in trade agreements to
which the United States is a party. EPA
may establish a tolerance that is
different from a Codex MRL; however,
E:\FR\FM\30OCR1.SGM
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50089
Federal Register / Vol. 82, No. 208 / Monday, October 30, 2017 / Rules and Regulations
FFDCA section 408(b)(4) requires that
EPA explain the reasons for departing
from the Codex level.
Codex has established an MRL for
residues of hexythiazox on hops at 3
ppm. The U.S. tolerance for residues of
hexythiazox on hops cannot be
harmonized based on approved label
instructions. Based on available residue
data, compliance with label instructions
would result in exceedances of a
tolerance harmonized with the Codex
MRL.
nlaroche on DSK9F9SC42PROD with RULES
V. Conclusion
Therefore, the existing tolerance for
residues of the ovicide/miticide
hexythiazox and its metabolites
containing the (4-chlorophenyl)-4methyl-2-oxo-3-thiazolidine moiety in/
on hop, dried cones is increased from
2.0 ppm to 20 ppm.
VI. Statutory and Executive Order
Reviews
This action amends an existing
tolerance under FFDCA section 408(d)
in response to a petition submitted to
the Agency. The Office of Management
and Budget (OMB) has exempted these
types of actions from review under
Executive Order 12866, entitled
‘‘Regulatory Planning and Review’’ (58
FR 51735, October 4, 1993). Because
this action has been exempted from
review under Executive Order 12866,
this action is not subject to Executive
Order 13211, entitled ‘‘Actions
Concerning Regulations That
Significantly Affect Energy Supply,
Distribution, or Use’’ (66 FR 28355, May
22, 2001) or Executive Order 13045,
entitled ‘‘Protection of Children from
Environmental Health Risks and Safety
Risks’’ (62 FR 19885, April 23, 1997).
This action does not contain any
information collections subject to OMB
approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et
seq.), nor does it require any special
considerations under Executive Order
12898, entitled ‘‘Federal Actions to
Address Environmental Justice in
Minority Populations and Low-Income
Populations’’ (59 FR 7629, February 16,
1994).
Since tolerances and exemptions that
are established on the basis of a petition
under FFDCA section 408(d), such as
the tolerance in this final rule, do not
require the issuance of a proposed rule,
the requirements of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This action directly regulates growers,
food processors, food handlers, and food
retailers, not States or tribes, nor does
this action alter the relationships or
distribution of power and
VerDate Sep<11>2014
13:41 Oct 27, 2017
Jkt 244001
responsibilities established by Congress
in the preemption provisions of FFDCA
section 408(n)(4). As such, the Agency
has determined that this action will not
have a substantial direct effect on States
or tribal governments, on the
relationship between the national
government and the States or tribal
governments, or on the distribution of
power and responsibilities among the
various levels of government or between
the Federal Government and Indian
tribes. Thus, the Agency has determined
that Executive Order 13132, entitled
‘‘Federalism’’ (64 FR 43255, August 10,
1999) and Executive Order 13175,
entitled ‘‘Consultation and Coordination
with Indian Tribal Governments’’ (65 FR
67249, November 9, 2000) do not apply
to this action. In addition, this action
does not impose any enforceable duty or
contain any unfunded mandate as
described under Title II of the Unfunded
Mandates Reform Act (UMRA) (2 U.S.C.
1501 et seq.).
This action does not involve any
technical standards that would require
Agency consideration of voluntary
consensus standards pursuant to section
12(d) of the National Technology
Transfer and Advancement Act
(NTTAA) (15 U.S.C. 272 note).
VII. Congressional Review Act
Pursuant to the Congressional Review
Act (5 U.S.C. 801 et seq.), EPA will
submit a report containing this rule and
other required information to the U.S.
Senate, the U.S. House of
Representatives, and the Comptroller
General of the United States prior to
publication of the rule in the Federal
Register. This action is not a ‘‘major
rule’’ as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: October 6, 2017.
Daniel J. Rosenblatt,
Acting Director, Registration Division, Office
of Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Section 180.448 is amended by
revising the entry ‘‘Hop, dried cones’’ in
the table in paragraph (a) to read as
follows:
■
PO 00000
Frm 00031
Fmt 4700
Sfmt 4700
§ 180.448 Hexythiazox; tolerances for
residues.
(a) * * *
Parts per
million
Commodity
*
*
*
*
Hop, dried cones ........................
*
*
*
*
*
*
*
*
*
20
*
*
[FR Doc. 2017–23439 Filed 10–27–17; 8:45 am]
BILLING CODE 6560–50–P
DEPARTMENT OF TRANSPORTATION
National Highway Traffic Safety
Administration
49 CFR Part 571
[Docket No. NHTSA–2015–0056]
RIN 2127–AL78
Motor Vehicle Safety Standards;
Electronic Stability Control Systems
for Heavy Vehicles
National Highway Traffic
Safety Administration (NHTSA),
Department of Transportation.
ACTION: Final rule; response to petition
for reconsideration.
AGENCY:
This final rule addresses a
petition for reconsideration of the final
rule for FMVSS No. 136, Electronic
stability control systems for heavy
vehicles. The petitioner, Truck and
Engine Manufacturers Association
(EMA), requested that NHTSA amend
the test conditions for the agency’s
performance test by allowing a larger
lane width for long wheelbase truck
tractors. After a careful technical review
of the petition and the issues raised by
the petitioner, the agency has decided to
grant the petition because there is
sufficient evidence to indicate that a
larger lane width is needed for testing
of long wheelbase truck tractors.
DATES: The effective date of this final
rule is November 29, 2017.
Petitions for reconsideration: Petitions
for reconsideration of this final rule
must be received not later than
December 14, 2017.
ADDRESSES: Petitions for reconsideration
of this final rule must refer to the docket
and notice number set forth above and
be submitted to the Administrator,
National Highway Traffic Safety
Administration, 1200 New Jersey
Avenue SE., Washington, DC 20590.
FOR FURTHER INFORMATION CONTACT: For
technical issues, you may contact
SUMMARY:
E:\FR\FM\30OCR1.SGM
30OCR1
]]>Agencies
[Federal Register Volume 82, Number 208 (Monday, October 30, 2017)]
[Rules and Regulations]
[Pages 50084-50089]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-23439]
=======================================================================
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2017-0155; FRL-9968-12]
Hexythiazox; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation amends an existing tolerance for residues of
the ovicide/miticide hexythiazox in/on hop, dried cones, by increasing
the current tolerance from 2.0 parts per million (ppm) to 20 ppm. Gowan
Company requested modification of this tolerance under the Federal
Food, Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective October 30, 2017. Objections and
requests for hearings must be received
[[Page 50085]]
on or before December 29, 2017, and must be filed in accordance with
the instructions provided in 40 CFR part 178 (see also Unit I.C. of the
SUPPLEMENTARY INFORMATION).
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2017-0155, is available at https://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 https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Michael L. Goodis, P.E., Director,
Registration Division (7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460-0001; main telephone number: (703) 305-7090; email
address: [email protected].
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
B. How can I get electronic access to other related information?
You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing Office's e-CFR site at 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 number EPA-HQ-OPP-2017-0155 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
December 29, 2017. Addresses for mail and hand delivery of objections
and hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2017-0155, by one of
the following methods:
Federal eRulemaking Portal: 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 June 8, 2017 (82 FR 26641) (FRL-9961-
14), EPA issued a document pursuant to the Federal Food, Drug, and
Cosmetic Act (FFDCA) section 408(d)(3), 21 U.S.C. 346a(d)(3),
announcing the filing of a pesticide petition (PP #6F8489) by Gowan
Company, P.O. Box 5569, Yuma, AZ 85366-5569. This petition requested
that 40 CFR 180.448 be amended by establishing a tolerance for residues
of hexythiazox in or on hop, dried cones at 20 ppm. This document
referenced a summary of the petition prepared by Gowan Company, the
registrant, which is available in the docket, https://www.regulations.gov. No comments were received in response to the
referenced notice of filing.
III. Aggregate Risk Assessment and Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
.''
Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for hexythiazox including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with hexythiazox follows.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children.
Hexythiazox has low acute toxicity by the oral, dermal, and
inhalation routes of exposure. It produces mild eye irritation and is
not a skin irritant or skin sensitizer. Hexythiazox is associated with
toxicity of the liver and
[[Page 50086]]
adrenals following subchronic and chronic exposure to dogs, rats, and
mice, with the dog being the most sensitive species. The prenatal
developmental studies in rabbits and rats and the two-generation
reproduction study in rats showed no indication of increased
susceptibility to in utero or postnatal exposure to hexythiazox.
Reproductive toxicity was not observed. There is no concern for
immunotoxicity or neurotoxicity following exposure to hexythiazox. The
toxicology database for hexythiazox does not show any evidence of
treatment-related effects on the immune system.
Hexythiazox is classified as ``Likely to be Carcinogenic to
Humans'' based on a treatment-related increase in benign and malignant
liver tumors in female mice and the presence of mammary gland tumors
(fibroadenomas) in male rats; however, the evidence as a whole was not
strong enough to warrant the use of a linear low dose extrapolation
model applied to the animal data (Q1*) for a quantitative
estimation of human risk because the common liver tumors (benign and
malignant) were only observed in high-dose female mice, and benign
mammary gland tumors were only observed in high-dose male rats. Since
the effects seen in the study that serves as the basis for the chronic
reference dose (cRfD) occurred at doses substantially below the lowest
dose that induced tumors (and there is no mutagenic concern for
hexythiazox), the cRfD is considered protective of all chronic effects,
including potential carcinogenicity.
Specific information on the studies received and the nature of the
adverse effects caused by hexythiazox as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at https://www.regulations.gov within the document entitled ``Hexythiazox. Human
Health Risk Assessment for Amended Use on Hops,'' dated September 5,
2017, which can be found in docket ID number EPA-HQ-OPP-2017-0155.
B. Toxicological Points of Departure/Levels of Concern
Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see https://www.epa.gov/pesticides/factsheets/riskassess.htm. A summary of the toxicological
endpoints for hexythiazox used for human risk assessment is shown in
the Table of this unit.
Table--Summary of Toxicological Doses and Endpoints for Hexythiazox for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
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 Study--
UFA = 10x........... mg/kg/day. Dogs.
UFH = 10x........... cPAD = 0.025....... LOAEL = 12.5 mg/kg/day based on
FQPA SF = 1x........ increased absolute and relative
adrenal weights, and associated
adrenal histopathology.
Incidental Oral Short-Term (1 to NOAEL= 30 mg/kg/day. Residential LOC for 2-Generation Reproduction Study--
30 days) and Intermediate-Term UFA = 10x........... MOE = 100. Rat.
(1 to 6 months). UFH = 10x........... LOAEL = 180 mg/kg/day, based on
FQPA SF = 1x........ decreased pup body weight during
lactation and delayed hair growth
and/or eye opening, and decreased
parental body-weight gain and
increased absolute and relative
liver, kidney, and adrenal
weights.
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------
Inhalation Short-Term (1 to 30 Oral NOAEL= 30 mg/kg/ Residential LOC for 2-Generation Reproduction Study--
days) and Intermediate-Term (1 day. MOE = 100. Rat.
to 6 months). UFA = 10x........... LOAEL = 180 mg/kg/day, based on
UFH = 10x........... decreased pup body weight during
FQPA SF = 1x........ lactation and delayed hair growth
and/or eye opening, and decreased
parental body-weight gain and
increased absolute and relative
liver, kidney, and adrenal
weights.
----------------------------------------------------------------------------------------------------------------
[[Page 50087]]
Cancer (oral, dermal, and Classification: ``Likely to be Carcinogenic to Humans.'' A quantification of
inhalation). risk using a non-linear approach; i.e., RfD, for hexythiazox will adequately
account for all chronic toxicity, including carcinogenicity, that could
result from exposure to hexythiazox.
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor.
UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among
members of the human population (intraspecies).
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to hexythiazox, EPA considered exposure under the petitioned-
for tolerances as well as all existing hexythiazox tolerances in 40 CFR
180.448. EPA assessed dietary exposures from hexythiazox in food as
follows:
i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure. No toxic effects
attributable to a single dose of hexythiazox were observed in the
toxicology database; therefore, a quantitative acute dietary exposure
and risk assessment is unnecessary.
ii. Chronic exposure. In conducting the chronic dietary (food and
drinking water) exposure assessment, EPA used the Dietary Exposure
Evaluation Model (DEEM-FCID), Version 3.16, which uses food consumption
data from the U.S. Department of Agriculture's National Health and
Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA)
from 2003-2008. As to residue levels in food, EPA used tolerance-level
residues, assumed 100 percent crop treated (PCT), and incorporated DEEM
7.81 default processing factors when processing data were not
available.
iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that a nonlinear RfD approach is appropriate for assessing
cancer risk to hexythiazox. Cancer risk was assessed using the same
exposure estimates as discussed in Unit III.C.1.ii., Chronic exposure.
iv. Anticipated residue and percent crop treated (PCT) information.
EPA did not use anticipated residue and/or PCT information in the
dietary assessment for hexythiazox. Tolerance-level residues and/or 100
PCT were assumed for all food commodities.
2. Dietary exposure from drinking water. The Agency used screening-
level water exposure models in the dietary exposure analysis and risk
assessment for hexythiazox in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of hexythiazox. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at https://www.epa.gov/oppefed1/models/water/index.htm.
Surface water and groundwater estimated drinking water
concentrations (EDWCs) do not result in any change to the existing
EDWCs determined from a recent drinking water assessment derived on
hops. Specifically, since hops is already a registered use that was
recently assessed during registration review, no new drinking water
scenarios were identified with this proposed increase in application
rates that would require a new drinking water assessment to be
conducted. In fact, the highest EDWCs associated with all uses of
hexythiazox continue to be from use on sorghum in the Western U.S.,
using the Pesticide Root Zone Model (PRZM) surface water modeling
scenario. Furthermore, based on the Agency's previous assessment, the
EDWCs of hexythiazox for chronic exposures are estimated to be 4.3
parts per billion (ppb) for surface water and 2.4 ppb for ground water
(DP 433290, 5/9/2016; DP 404023, 1/17/2012), and the higher of these
values was used in the dietary exposure model to assess chronic dietary
risk.
3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets). Hexythiazox is
currently registered for the following residential uses, including
ornamental landscape plantings, turf, and fruit and nut trees in
residential sites.
EPA assessed residential exposure using the following assumptions:
Residential handler exposures are expected to be short-term (1 to 30
days) via either the dermal or inhalation routes of exposures. Since a
quantitative dermal risk assessment is not needed for hexythiazox,
handler MOEs were calculated for the inhalation route of exposure only.
EPA uses the term ``post-application'' to describe exposure to
individuals that occur as a result of being in an environment that has
been previously treated with a pesticide. There is potential for post-
application for individuals exposed as a result of being in an
environment that has been previously treated with hexythiazox. Adult
residential post-application dermal exposures were not assessed since
no dermal hazard was identified for hexythiazox. The residential post-
application exposure assessment for children included incidental oral
exposure resulting from transfer of residues from the hand-to-mouth,
object to- mouth, and from incidental ingestion of soil.
Further information regarding EPA standard assumptions and generic
inputs for residential exposures may be found at 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 pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
EPA has not found hexythiazox to share a common mechanism of
toxicity with any other substances, and hexythiazox does not appear to
produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action; therefore, EPA has assumed that
hexythiazox does not have a common mechanism of toxicity with other
substances. For information
[[Page 50088]]
regarding EPA's efforts to determine which chemicals have a common
mechanism of toxicity and to evaluate the cumulative effects of such
chemicals, see EPA's Web site at 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 Food Quality
Protection Act Safety Factor (FQPA SF). In applying this provision, EPA
either retains the default value of 10X, or uses a different additional
safety factor when reliable data available to EPA support the choice of
a different factor.
2. Prenatal and postnatal sensitivity. The prenatal and postnatal
toxicology data base indicates no increased susceptibility of rats or
rabbits to in utero and/or postnatal exposure to hexythiazox.
3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1x. That decision is based on the following
findings:
i. The toxicity database for hexythiazox is complete.
ii. There is no indication that hexythiazox is a neurotoxic
chemical and there is no need for a developmental neurotoxicity study
or additional UFs to account for neurotoxicity.
iii. There is no evidence that hexythiazox results in increased
susceptibility in in utero rats or rabbits in the prenatal
developmental studies or in young rats in the 2-generation reproduction
study.
iv. There are no residual uncertainties identified in the exposure
databases. EPA made conservative (protective) assumptions in the ground
and surface water modeling used to assess exposure to hexythiazox in
drinking water. EPA used similarly conservative assumptions to assess
post-application exposure of children as well as incidental oral
exposure of toddlers. These assessments will not underestimate the
exposure and risks posed by hexythiazox.
E. Aggregate Risks and Determination of Safety
EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
1. Acute risk. An acute aggregate risk assessment takes into
account acute exposure estimates from dietary consumption of food and
drinking water. No toxic effects attributable to a single dose of
hexythiazox were observed in the toxicology database; therefore, a
quantitative acute aggregate risk assessment for hexythiazox is not
required.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
hexythiazox from food and water will utilize 93% of the cPAD for
children 1-2 years of age, the population group receiving the greatest
exposure. Based on the explanation in Unit III.C.3., regarding
residential use patterns, chronic residential exposure to residues of
hexythiazox is not expected.
3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).
Hexythiazox is currently registered for uses that could result in
short-term residential exposure, and the Agency has determined that it
is appropriate to aggregate chronic exposure through food and water
with short-term residential exposures to hexythiazox. Using the
exposure assumptions described in this unit for short-term exposures,
EPA has concluded the combined short-term food, drinking water, and
residential inhalation exposures result in an aggregate MOE for adults
(7,500) that greatly exceeds the LOC of 100, and is not of concern.
4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level).
Hexythiazox is currently registered for uses that could result in
intermediate-term residential exposure, and the Agency has determined
that it is appropriate to aggregate chronic exposure through food and
water with intermediate-term residential exposures to hexythiazox.
Using the exposure assumptions described in this unit for intermediate-
term exposures, EPA has concluded the combined intermediate-term food,
drinking water, and residential oral exposures result in an aggregate
MOE for children (1,150) that greatly exceeds the LOC of 100, and is
not of concern.
5. Aggregate cancer risk for U.S. population. As discussed in Unit
III. C.1.iii., EPA concluded that regulation based on the cRfD will be
protective for both chronic and carcinogenic risks. As noted in this
unit, there are no chronic risks of concern; therefore, the Agency
concludes that aggregate exposure to hexythiazox will not pose a cancer
risk.
6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the U.S. general population, or to infants and children from
aggregate exposure to hexythiazox residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
An adequate High performance liquid chromatography using ultra-
violet detection (HPLC/UV) analytical method is available for the
enforcement of tolerances for residues of hexythiazox and its
metabolites containing the PT-1-3 moiety in crop and livestock
commodities. This method is listed in the U.S. EPA Index of Residue
Analytical Methods under hexythiazox as method AMR-985-87. The limit of
quantification (LOQ) for hexythiazox residues is 0.02 ppm.
B. International Residue Limits
In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by Federal
Food, Drug and Cosmetic Act (FFDCA) section 408(b)(4). The Codex
Alimentarius is a joint United Nations Food and Agriculture
Organization/World Health Organization food standards program, and it
is recognized as an international food safety standards-setting
organization in trade agreements to which the United States is a party.
EPA may establish a tolerance that is different from a Codex MRL;
however,
[[Page 50089]]
FFDCA section 408(b)(4) requires that EPA explain the reasons for
departing from the Codex level.
Codex has established an MRL for residues of hexythiazox on hops at
3 ppm. The U.S. tolerance for residues of hexythiazox on hops cannot be
harmonized based on approved label instructions. Based on available
residue data, compliance with label instructions would result in
exceedances of a tolerance harmonized with the Codex MRL.
V. Conclusion
Therefore, the existing tolerance for residues of the ovicide/
miticide hexythiazox and its metabolites containing the (4-
chlorophenyl)-4-methyl-2-oxo-3-thiazolidine moiety in/on hop, dried
cones is increased from 2.0 ppm to 20 ppm.
VI. Statutory and Executive Order Reviews
This action amends an existing tolerance under FFDCA section 408(d)
in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this action has been
exempted from review under Executive Order 12866, this action is not
subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997). This action does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This action directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(UMRA) (2 U.S.C. 1501 et seq.).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).
VII. Congressional Review Act
Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: October 6, 2017.
Daniel J. Rosenblatt,
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. Section 180.448 is amended by revising the entry ``Hop, dried
cones'' in the table in paragraph (a) to read as follows:
Sec. 180.448 Hexythiazox; tolerances for residues.
(a) * * *
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Hop, dried cones............................................ 20
* * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. 2017-23439 Filed 10-27-17; 8:45 am]
BILLING CODE 6560-50-P
