Pyroxasulfone; Pesticide Tolerances, 22854-22859 [2018-10582]
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ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2015–0787; FRL–9977–25]
Pyroxasulfone; Pesticide Tolerances
Environmental Protection
Agency (EPA).
AGENCY:
Final rule.
This regulation establishes
tolerances for residues of pyroxasulfone
and its metabolites in or on vegetable,
tuberous and corm, subgroup 1C;
vegetable, bulb, group 3–07; and
potatoes, granules/flakes. K–I Chemical
USA, Inc. requested these tolerances
under the Federal Food, Drug, and
Cosmetic Act (FFDCA).
DATES: This regulation is effective May
17, 2018. Objections and requests for
hearings must be received on or before
July 16, 2018, and must be filed in
accordance with the instructions
provided in 40 CFR part 178 (see also
Unit I.C. of the SUPPLEMENTARY
INFORMATION).
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The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2015–0787, 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 Goodis, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC
20460–0001; main telephone number:
(703) 305–7090; email address:
RDFRNotices@epa.gov.
SUPPLEMENTARY INFORMATION:
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SUMMARY:
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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
identify docket ID number EPA–HQ–
OPP–2015–0787 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 July 16, 2018. Addresses for mail
and hand delivery of objections and
hearing requests are provided in 40 CFR
178.25(b).
In addition to filing an objection or
hearing request with the Hearing Clerk
as described in 40 CFR part 178, please
submit a copy of the filing (excluding
any Confidential Business Information
(CBI)) for inclusion in the public docket.
Information not marked confidential
pursuant to 40 CFR part 2 may be
disclosed publicly by EPA without prior
notice. Submit the non-CBI copy of your
objection or hearing request, identified
by docket ID number EPA–HQ–OPP–
2015–0787, 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.
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II. Summary of Petitioned-For
Tolerance
In the Federal Register of January 26,
2018 (83 FR 3659) (FRL–9971–46), EPA
issued a document pursuant to FFDCA
section 408(d)(3), 21 U.S.C. 346a(d)(3),
announcing the filing of a pesticide
petition (PP 5F8521) by K–I Chemical
USA, Inc., 11 Martine Ave., Suite 970,
White Plains, NY 10606. The petition
requested that 40 CFR part 180.659 be
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amended by establishing tolerances for
residues of the herbicide pyroxasulfone,
(3-[5-(difluoromethoxy)-1-methyl-3(trifluoromethyl)pyrazol-4-yl
methylsulfonyl]-4,5-dihydro-5,5dimethyl-1,2-oxazole) in or on Crop
Subgroup 1C, tuberous and corm
vegetables (except granular/flakes and
chips) at 0.05 parts per million (ppm);
Crop Subgroup 3–07, bulb vegetables at
0.15 ppm; potatoes, granular/flakes at
0.3 ppm; and potato chips at 0.06 ppm.
That document referenced a summary of
the petition prepared by K–I Chemical
USA, Inc., the registrant, which is
available in the docket, https://
www.regulations.gov. No comments
were received in response to the notice
of filing.
Because the January 26, 2018,
document identified the K–I Chemical
petition by the wrong petition number,
EPA published another document in the
Federal Register assigning the correct
petition number to the K–I Chemical
petition—PP6F8521. That document
was published in the Federal Register
on March 15, 2018 (83 FR 11448) (FRL–
9974–72). No relevant comments were
received on the notice of filing.
Based upon review of the data
supporting the petition, EPA has
modified the levels at which some of the
tolerances are being established and also
modified some of the crop definitions.
The reasons for these changes are
explained in Unit IV.C.
III. Aggregate Risk Assessment and
Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA
allows EPA to establish a tolerance (the
legal limit for a pesticide chemical
residue in or on a food) only if EPA
determines that the tolerance is ‘‘safe.’’
Section 408(b)(2)(A)(ii) of FFDCA
defines ‘‘safe’’ to mean that ‘‘there is a
reasonable certainty that no harm will
result from aggregate exposure to the
pesticide chemical residue, including
all anticipated dietary exposures and all
other exposures for which there is
reliable information.’’ This includes
exposure through drinking water and in
residential settings, but does not include
occupational exposure. Section
408(b)(2)(C) of FFDCA requires EPA to
give special consideration to exposure
of infants and children to the pesticide
chemical residue in establishing a
tolerance and to ‘‘ensure that there is a
reasonable certainty that no harm will
result to infants and children from
aggregate exposure to the pesticide
chemical residue. . . .’’
Consistent with FFDCA section
408(b)(2)(D), and the factors specified in
FFDCA section 408(b)(2)(D), EPA has
reviewed the available scientific data
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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 pyroxasulfone
including exposure resulting from the
tolerances established by this action.
EPA’s assessment of exposures and risks
associated with pyroxasulfone 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.
The toxicology database for
pyroxasulfone is adequate for evaluating
and characterizing toxicity and selecting
endpoints for purposes of this risk
assessment. Pyroxasulfone acute
toxicity to mammals is low by all routes
of exposure. Subchronic and chronic
oral studies in mice, rats and dogs
produced a variety of effects including
cardiac toxicity (increased
cardiomyopathy), liver toxicity
(centrilobular hepatocellular
hypertrophy, histopathological and/or
clinical pathological indicators), kidney
toxicity (nephropathy), neurotoxicity
(impaired hind limb function, ataxia,
tremors, sciatic nerve lesions, axonal/
myelin degeneration in the sciatic nerve
and spinal cord sections), skeletal
muscle myopathy, urinary bladder
mucosal hyperplasia, and urinary
bladder transitional cell papillomas.
Minimal to mild cardiac myofiber
degeneration and local inflammation
were also seen in a rat dermal toxicity
study. Neurotoxicity was also seen in a
developmental neurotoxicity study in
rats (decreased brain weight, decreased
thickness of the hippocampus, corpus
callosum and cerebellum in offspring).
Dogs appear to be the most sensitive
species to the neurotoxic effects of
pyroxasulfone. Immunotoxicity studies
in rats and mice show no evidence of
immunotoxic effects from
pyroxasulfone.
There is evidence of fetal and
offspring susceptibility in the
developmental neurotoxicity study in
rats as effects occurred in the absence of
maternal toxicity. There is no concern
for reproductive toxicity. Pyroxasulfone
is classified as ‘‘Not Likely to be
Carcinogenic to Humans’’ at doses that
do not cause crystals with subsequent
calculi formation resulting in cellular
damage of the urinary tract. The Agency
has determined that the quantification
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of risk using a non-linear approach (i.e.,
reference dose (RfD)) will adequately
account for all chronic toxicity,
including carcinogenicity, that could
result from exposure to pyroxasulfone.
Specific information on the studies
received and the nature of the adverse
effects caused by pyroxasulfone as the
no-observed-adverse effect level
(NOAEL) and lowest-observed adverse
effect level (LOAEL) from the toxicity
studies can be found at https://
www.regulations.gov in document
‘‘Pyroxasulfone Human Health Risk
Assessment for the Section 3 New Uses
of Pyroxasulfone on Crop Subgroup 1C,
tuberous and corm vegetables and Crop
Group 3–07, bulb vegetables’’ at pages
39–53 in docket ID number EPA–HQ–
OPP–2015–0787.
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 the NOAEL and the
LOAEL are identified. 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
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 use https://www.epa.gov/
pesticide-science-and-assessingpesticide-risks/assessing-human-healthrisk-pesticides.
A summary of the toxicological
endpoints for pyroxasulfone used for
human risk assessment is shown in the
Table 1 of this unit.
TABLE 1—TOXICOLOGICAL DOSES AND ENDPOINTS FOR PYROXASULFONE FOR USE IN DIETARY HUMAN HEALTH RISK
ASSESSMENTS
Exposure/scenario
Point of
departure
Uncertainty/
FQPA safety factors
RfD & PAD
Study and toxicological effects
Acute Dietary (General Population,
including Infants and Children).
NOAEL= 100 mg/kg .....
UFA= 10x .....................
UFH=10x
FQPA SF=1x
Acute RfD = 1.0 mg/kg
aPAD = 1.0 mg/kg
Chronic Dietary (All Populations) .....
NOAEL= 2 mg/kg/day ..
UFA= 10x .....................
UFH=10x
FQPA SF=1x
Chronic RfD = 0.02 mg/
kg/day.
cPAD = 0.02 mg/kg/day
Developmental neurotoxicity study (DNT) in
rats.
The LOAEL of 300 mg/kg/day is based on decreased brain weight in both sexes, reduced
thickness of the hippocampus, corpus
callosum and cerebellum in postnatal day
(PND) 21 female offspring.
One- year chronic dog study
The LOAEL of 10 mg/kg/day is based on impaired hind limb function, ataxia, hind limb
twitching and tremors; clinical pathology: increased
creatine
kinase,
aspartate
aminotransferase; axonal/myelin degeneration of the sciatic nerve and spinal cord sections.
Cancer (all routes) ............................
‘‘Not Likely to be Carcinogenic to Humans’’ at doses that do not cause crystals with subsequent calculi formation resulting in
cellular damage of the urinary tract. Risk is quantified using a non-linear (i.e., RfD) approach.
Point of Departure (POD) = A data point or an estimated point that is derived from observed dose-response data and used to mark the beginning of extrapolation to
determine risk associated with lower environmentally relevant human exposures. NOAEL = no observed adverse effect level. LOAEL = lowest observed adverse effect level. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members of the human
population (intraspecies). FQPA SF = FQPA Safety Factor. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. MOE = margin of exposure. LOC = level of concern. N/A = not applicable.
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C. Exposure Assessment
1. Dietary exposure from food and
feed uses. In evaluating dietary
exposure to pyroxasulfone, EPA
considered exposure under the
petitioned-for tolerances as well as all
existing pyroxasulfone tolerances in 40
CFR 180.659. EPA assessed dietary
exposures from pyroxasulfone 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.
Such effects were identified for
pyroxasulfone. In estimating acute
dietary exposure, EPA used food
consumption data from the United
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States Department of Agriculture
(USDA) 2003–2008 National Health and
Nutrition Examination Survey/What We
Eat in America (NHANES/WWEIA). As
to residue levels in food, EPA assumed
100 percent crop treated (PCT) and
tolerance-level residues adjusted for
metabolites which are not in the
tolerance expression.
ii. Chronic exposure. In conducting
the chronic dietary exposure assessment
EPA used the food consumption data
from the USDA 2003–2008 (NHANES/
WWEIA). As to residue levels in food,
EPA assumed 100 PCT and tolerancelevel residues adjusted for metabolites
which are not in the tolerance
expression.
iii. Cancer. Based on the data
summarized in Unit III.A., EPA has
classified pyroxasulfone as ‘‘Not Likely
to be Carcinogenic to Humans’’ at doses
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that do not cause crystals with
subsequent calculi formation resulting
in cellular damage of the urinary tract.
The Agency has determined that the
quantification of risk using a non-linear
approach (i.e., RfD) will adequately
account for all chronic toxicity,
including carcinogenicity, that could
result from exposure to pyroxasulfone.
iv. Anticipated residue and percent
crop treated (PCT) information. EPA did
not use anticipated residue and PCT
information in the dietary assessment
for pyroxasulfone. Tolerance-level
residues and 100% crop treated (CT)
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 pyroxasulfone in drinking water.
These simulation models take into
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account data on the physical, chemical,
and fate/transport characteristics of
pyroxasulfone. Further information
regarding EPA drinking water models
used in pesticide exposure assessment
can be found at at https://www.epa.gov/
pesticide-science-and-assessingpesticide-risks/assessing-human-healthriskpesticides.
Based on the Pesticide Root Zone
Model Ground Water (PRZM version
3.122)/Exposure Analysis Modeling
System-Superseded (EXAMS version
2.98.04), the estimated concentrations of
pyroxasulfone in surface water were
minimal, and the highest estimated
drinking water concentrations (EDWCs)
of pyroxasulfone residues were from a
Tier II PRZM–GW modeling at an
application rate of 0.267 lbs active
ingredient/Acre for registered crops.
The same EDWCs have been used for
the current human health dietary risk
assessment. The EDWCs for peak
concentration (used in the acute
assessment) and 30-year average
concentration (used in the chronic
assessment) were 0.210 and 0.174 mg/L
(ppm), respectively. Water residues
were incorporated in the Dietary
Exposure Evaluation Model—Food
Commodity Intake Database (DEEM–
FCID) into the food categories ‘‘water,
direct, all sources’’ and ‘‘water, indirect,
all sources.’’
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).
Pyroxasulfone is not registered for any
specific use patterns that would result
in residential exposure.
4. Cumulative effects from substances
with a common mechanism of toxicity.
Section 408(b)(2)(D)(v) of FFDCA
requires that, when considering whether
to establish, modify, or revoke a
tolerance, the Agency consider
‘‘available information’’ concerning the
cumulative effects of a particular
pesticide’s residues and ‘‘other
substances that have a common
mechanism of toxicity.’’
EPA has not found pyroxasulfone to
share a common mechanism of toxicity
with any other substances, and
pyroxasulfone does not appear to
produce a toxic metabolite produced by
other substances. For the purposes of
this tolerance action, therefore, EPA has
assumed that pyroxasulfone 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
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the cumulative effects of such
chemicals, see EPA’s website at https://
www.epa.gov/pesticide-science-andassessing-pesticide-risks/assessinghuman-health-riskpesticides.
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 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.
Pyroxasulfone did not exhibit
developmental toxicity in the rat
guideline study at the limit dose of
1,000 mg/kg/day and it exhibited slight
developmental toxicity in rabbits
(reduced fetal weight and resorptions) at
the limit dose of 1,000 mg/kg/day.
However, developmental effects were
noted in offspring at 300 mg/kg/day in
the rat DNT study characterized as
decreased brain weight and
morphometric changes. Developmental
effects in the rabbit developmental
study and DNT study occurred in the
absence of maternal toxicity, indicating
potential increased quantitative
susceptibility of offspring. In a rat
reproductive toxicity study, reduced
pup weight and body weight gains
during lactation occurred at similar
doses causing pronounced maternal
toxicity (reduced body weight, body
weight gain and food consumption and
increased kidney weight,
cardiomyopathy and urinary bladder
mucosal hyperplasia with
inflammation).
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
pyroxasulfone is complete.
ii. Available data indicates that
pyroxasulfone produces neurotoxic
effects in rats. The toxicity database
includes specific acute and subchronic
neurotoxicity tests, as well as a DNT
study. Although the DNT indicated
offspring are more sensitive to
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neurotoxic effects of pyroxasulfone, the
dose-response is well characterized for
neurotoxicity and a NOAEL is
identified; therefore, there is no residual
uncertainty with regard to neurotoxic
effects for which a 10X must be
retained.
iii. Evidence of increased
susceptibility of fetuses and offspring
was seen in a DNT study in rats and a
developmental study in rabbits
following in utero or post-natal
exposure to pyroxasulfone. However, no
susceptibility was seen in the rat
developmental or reproduction studies.
In rabbits, developmental toxicity was
only seen at the limit dose of 1000 mg/
kg/day as reduced fetal weight and
increased fetal resorptions with a
NOAEL of 500 mg/kg/day for these
effects, compared to no maternal
toxicity at these doses. In a DNT study
in rats, offspring toxicity was seen at
300 mg/kg/day compared to no maternal
toxicity at 900 mg/kg/day. This
increased susceptibility is occurring at
high doses. NOAELs and LOAELs have
been identified for all effects of concern
and thus, a clear dose response has been
well defined. Therefore, residual
uncertainties or concerns for pre- and/
or post-natal toxicity are minimal, and
EPA concludes that reducing the FQPA
safety factor to 1X will be protective of
such effects.
iv. There are no residual uncertainties
identified in the exposure databases.
The dietary food exposure assessments
were performed based on 100% CT and
tolerance-level residues. EPA made
conservative (protective) assumptions in
the ground and surface water modeling
used to assess exposure to
pyroxasulfone in drinking water. These
assessments will not underestimate the
exposure and risks posed by
pyroxasulfone.
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 population
adjusted dose (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. Using the exposure
assumptions discussed in this unit for
acute exposure, the acute dietary
exposure from food and water to
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pyroxasulfone will occupy 3.7% of the
aPAD for all infants less than 1-year old,
the population group receiving the
greatest exposure.
2. Chronic risk. Using the exposure
assumptions described in this unit for
chronic exposure, EPA has concluded
that chronic exposure to pyroxasulfone
from food and water will utilize 50% of
the cPAD for all infants less than 1-year
old, the population group receiving the
greatest exposure.
3. Short-term and intermediate-term
risk. Short-term and intermediate-term
aggregate exposure takes into account
short-term and intermediate-term
residential exposure plus chronic
exposure to food and water (considered
to be a background exposure level).
Although short-term and
intermediate-term adverse effects were
identified, pyroxasulfone is not
registered for any use patterns that
would result in residential exposure.
Therefore, EPA relies on the chronic
dietary risk assessment for evaluating
short-term and intermediate-term risk
for pyroxasulfone.
4. Aggregate cancer risk for U.S.
population. As explained in Unit III.A.,
the Agency has determined that the
quantification of risk using a non-linear
(i.e., RfD) approach will adequately
account for all chronic toxicity,
including carcinogenicity, that could
result from exposure to pyroxasulfone.
Therefore, based on the results of the
chronic risk assessment discussed in
Unit III.E.2., pyroxasulfone is not
expected to pose a cancer risk to
humans.
5. Determination of safety. Based on
these risk assessments, EPA concludes
that there is a reasonable certainty that
no harm will result to the general
population, or to infants and children
from aggregate exposure to
pyroxasulfone residues.
IV. Other Considerations
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A. Analytical Enforcement Methodology
Adequate enforcement methodology
(high performance liquid
chromatography/triple quadrupole mass
spectrometry (LC/MS/MS) methods) are
available to enforce the tolerance
expression.
These methods may be requested
from: Chief, Analytical Chemistry
Branch, Environmental Science Center,
701 Mapes Rd., Ft. Meade, MD 20755–
5350; telephone number: (410) 305–
2905; email address: residuemethods@
epa.gov.
B. International Residue Limits
In making its tolerance decisions, EPA
seeks to harmonize U.S. tolerances with
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16:58 May 16, 2018
Jkt 244001
international standards whenever
possible, consistent with U.S. food
safety standards and agricultural
practices. EPA considers the
international maximum residue limits
(MRLs) established by the Codex
Alimentarius Commission (Codex), as
required by FFDCA section 408(b)(4).
The Codex Alimentarius is a joint
United Nations Food and Agriculture
Organization/World Health
Organization food standards program,
and it is recognized as an international
food safety standards-setting
organization in trade agreements to
which the United States is a party. EPA
may establish a tolerance that is
different from a Codex MRL; however,
FFDCA section 408(b)(4) requires that
EPA explain the reasons for departing
from the Codex level. The Codex has not
established a MRL for pyroxasulfone in
any of the proposed commodities.
C. Revisions to Petitioned-For
Tolerances
The vegetable, tuberous and corm,
subgroup 1C tolerance is being
established at 0.08 ppm instead of 0.05
ppm. The petitioner’s requested
tolerance level included only residues
from the parent and M1 metabolite. The
Agency is establishing this tolerance at
0.08 ppm to account for the
measurement of parent and four
metabolites. Applying processing factors
in accordance with the Agency’s policy
for determining such factors when
measuring multiple pesticide residues,
the Agency has determined that 0.20
ppm is an appropriate tolerance level
for granules/flakes. In addition, The
Agency has determined that a tolerance
for potato chips is not required because
residues will be within the tolerance
level established for subgroup 1C.
V. Conclusion
Therefore, tolerances are established
for residues of pyroxasulfone including
its metabolites and degradates, in or on
potatoes, granules/flakes at 0.20 ppm;
vegetable, bulb, group 3–07 at 0.15 ppm;
and vegetable, tuberous and corm,
subgroup 1C at 0.08 ppm.
VI. Statutory and Executive Order
Reviews
This action establishes tolerances
under FFDCA section 408(d) in
response to a petition submitted to the
Agency. The Office of Management and
Budget (OMB) has exempted these types
of actions from review under Executive
Order 12866, entitled ‘‘Regulatory
Planning and Review’’ (58 FR 51735,
October 4, 1993). Because this action
has been exempted from review under
Executive Order 12866, this action is
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not subject to Executive Order 13211,
entitled ‘‘Actions Concerning
Regulations That Significantly Affect
Energy Supply, Distribution, or Use’’ (66
FR 28355, May 22, 2001); Executive
Order 13045, entitled ‘‘Protection of
Children from Environmental Health
Risks and Safety Risks’’ (62 FR 19885,
April 23, 1997); or Executive Order
13771, entitled ‘‘Reducing Regulations
and Controlling Regulatory Costs’’ (82
FR 9339, February 3, 2017). This action
does not contain any information
collections subject to OMB approval
under the Paperwork Reduction Act
(PRA) (44 U.S.C. 3501 et seq.), nor does
it require any special considerations
under Executive Order 12898, entitled
‘‘Federal Actions to Address
Environmental Justice in Minority
Populations and Low-Income
Populations’’ (59 FR 7629, February 16,
1994).
Since tolerances and exemptions that
are established on the basis of a petition
under FFDCA section 408(d), such as
the tolerance in this final rule, do not
require the issuance of a proposed rule,
the requirements of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This action directly regulates growers,
food processors, food handlers, and food
retailers, not States or tribes, nor does
this action alter the relationships or
distribution of power and
responsibilities established by Congress
in the preemption provisions of FFDCA
section 408(n)(4). As such, the Agency
has determined that this action will not
have a substantial direct effect on States
or tribal governments, on the
relationship between the national
government and the States or tribal
governments, or on the distribution of
power and responsibilities among the
various levels of government or between
the Federal Government and Indian
tribes. Thus, the Agency has determined
that Executive Order 13132, entitled
‘‘Federalism’’ (64 FR 43255, August 10,
1999) and Executive Order 13175,
entitled ‘‘Consultation and Coordination
with Indian Tribal Governments’’ (65 FR
67249, November 9, 2000) do not apply
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).
E:\FR\FM\17MYR1.SGM
17MYR1
Federal Register / Vol. 83, No. 96 / Thursday, May 17, 2018 / Rules and Regulations
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).
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 300
[EPA–HQ–OLEM–2017–0604, 0606, 0607,
0609, 0611 and 0612; FRL–9978–14–OLEM]
National Priorities List
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
The Comprehensive
Environmental Response,
Compensation, and Liability Act of 1980
(‘‘CERCLA’’ or ‘‘the Act’’), as amended,
requires that the National Oil and
Hazardous Substances Pollution
Contingency Plan (‘‘NCP’’) include a list
of national priorities among the known
releases or threatened releases of
hazardous substances, pollutants or
contaminants throughout the United
States. The National Priorities List
(‘‘NPL’’) constitutes this list. The NPL is
intended primarily to guide the
Environmental Protection Agency (‘‘the
EPA’’ or ‘‘the agency’’) in determining
which sites warrant further
investigation. These further
investigations will allow the EPA to
assess the nature and extent of public
health and environmental risks
associated with the site and to
determine what CERCLA-financed
remedial action(s), if any, may be
appropriate. This rule adds six sites to
the General Superfund section of the
NPL.
SUMMARY:
List of Subjects in 40 CFR Part 180
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: May 8, 2018.
Daniel 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. In § 180.659, add alphabetically
‘‘Potato, granules/flakes’’, ‘‘Vegetable,
bulb, group 3–07’’, and ‘‘Vegetable,
tuberous and corm, subgroup 1C’’ to the
table in paragraph (a)(5) to read as
follows:
■
The document is effective on
June 18, 2018.
ADDRESSES: Contact information for the
EPA Headquarters:
• Docket Coordinator, Headquarters;
U.S. Environmental Protection Agency;
CERCLA Docket Office; 1301
Constitution Avenue NW, William
Jefferson Clinton Building West, Room
3334, Washington, DC 20004, 202/566–
0276.
The contact information for the
regional dockets is as follows:
• Holly Inglis, Region 1 (CT, ME, MA,
NH, RI, VT), U.S. EPA, Superfund
Records and Information Center, 5 Post
Office Square, Suite 100, Boston, MA
02109–3912; 617/918–1413.
• Ildefonso Acosta, Region 2 (NJ, NY,
PR, VI), U.S. EPA, 290 Broadway, New
York, NY 10007–1866; 212/637–4344.
• Lorie Baker (ASRC), Region 3 (DE,
DC, MD, PA, VA, WV), U.S. EPA,
Library, 1650 Arch Street, Mailcode
3HS12, Philadelphia, PA 19103; 215/
814–3355.
• Cathy Amoroso, Region 4 (AL, FL,
GA, KY, MS, NC, SC, TN), U.S. EPA, 61
DATES:
§ 180.659 Pyroxasulfone; tolerances for
residues.
(a) * * *
(5) * * *
Parts per
million
Commodity
*
*
*
*
Potato, granules/flakes ...............
*
0.20
*
*
*
*
Vegetable, bulb, group 3–07 ......
*
0.15
*
*
*
*
Vegetable, tuberous and corm,
subgroup 1C ...........................
*
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*
*
*
*
*
[FR Doc. 2018–10582 Filed 5–16–18; 8:45 am]
BILLING CODE 6560–50–P
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16:58 May 16, 2018
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0.08
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22859
Forsyth Street SW, Mailcode 9T25,
Atlanta, GA 30303; 404/562–8637.
• Todd Quesada, Region 5 (IL, IN, MI,
MN, OH, WI), U.S. EPA Superfund
Division Librarian/SFD Records
Manager SRC–7J, Metcalfe Federal
Building, 77 West Jackson Boulevard,
Chicago, IL 60604; 312/886–4465.
• Brenda Cook, Region 6 (AR, LA,
NM, OK, TX), U.S. EPA, 1445 Ross
Avenue, Suite 1200, Mailcode 6SFTS,
Dallas, TX 75202–2733; 214/665–7436.
• Kumud Pyakuryal, Region 7 (IA,
KS, MO, NE), U.S. EPA, 11201 Renner
Blvd., Mailcode SUPRSTAR, Lenexa, KS
66219; 913/551–7956.
• Victor Ketellapper, Region 8 (CO,
MT, ND, SD, UT, WY), U.S. EPA, 1595
Wynkoop Street, Mailcode 8EPR–B,
Denver, CO 80202–1129; 303/312–6578.
• Sharon Murray, Region 9 (AZ, CA,
HI, NV, AS, GU, MP), U.S. EPA, 75
Hawthorne Street, Mailcode SFD 6–1,
San Francisco, CA 94105; 415/947–
4250.
• Ken Marcy, Region 10 (AK, ID, OR,
WA), U.S. EPA, 1200 6th Avenue,
Mailcode ECL–112, Seattle, WA 98101;
206/463–1349.
FOR FURTHER INFORMATION CONTACT:
Terry Jeng, phone: (703) 603–8852,
email: jeng.terry@epa.gov Site
Assessment and Remedy Decisions
Branch, Assessment and Remediation
Division, Office of Superfund
Remediation and Technology
Innovation (Mailcode 5204P), U.S.
Environmental Protection Agency; 1200
Pennsylvania Avenue NW, Washington,
DC 20460; or the Superfund Hotline,
phone (800) 424–9346 or (703) 412–
9810 in the Washington, DC,
metropolitan area.
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Background
A. What are CERCLA and SARA?
B. What is the NCP?
C. What is the National Priorities List
(NPL)?
D. How are sites listed on the NPL?
E. What happens to sites on the NPL?
F. Does the NPL define the boundaries of
sites?
G. How are sites removed from the NPL?
H. May the EPA delete portions of sites
from the NPL as they are cleaned up?
I. What is the Construction Completion List
(CCL)?
J. What is the Sitewide Ready for
Anticipated Use measure?
K. What is state/tribal correspondence
concerning NPL Listing?
II. Availability of Information to the Public
A. May I review the documents relevant to
this final rule?
B. What documents are available for review
at the EPA Headquarters docket?
C. What documents are available for review
at the EPA regional dockets?
E:\FR\FM\17MYR1.SGM
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]]>Agencies
[Federal Register Volume 83, Number 96 (Thursday, May 17, 2018)]
[Rules and Regulations]
[Pages 22854-22859]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-10582]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2015-0787; FRL-9977-25]
Pyroxasulfone; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes tolerances for residues of
pyroxasulfone and its metabolites in or on vegetable, tuberous and
corm, subgroup 1C; vegetable, bulb, group 3-07; and potatoes, granules/
flakes. K-I Chemical USA, Inc. requested these tolerances under the
Federal Food, Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective May 17, 2018. Objections and
requests for hearings must be received on or before July 16, 2018, and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2015-0787, 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 Goodis, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; main telephone
number: (703) 305-7090; email address: [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.
[[Page 22855]]
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-2015-0787 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
July 16, 2018. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2015-0787, 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 January 26, 2018 (83 FR 3659) (FRL-9971-
46), EPA issued a document pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
5F8521) by K-I Chemical USA, Inc., 11 Martine Ave., Suite 970, White
Plains, NY 10606. The petition requested that 40 CFR part 180.659 be
amended by establishing tolerances for residues of the herbicide
pyroxasulfone, (3-[5-(difluoromethoxy)-1-methyl-3-
(trifluoromethyl)pyrazol-4-yl methylsulfonyl]-4,5-dihydro-5,5-dimethyl-
1,2-oxazole) in or on Crop Subgroup 1C, tuberous and corm vegetables
(except granular/flakes and chips) at 0.05 parts per million (ppm);
Crop Subgroup 3-07, bulb vegetables at 0.15 ppm; potatoes, granular/
flakes at 0.3 ppm; and potato chips at 0.06 ppm. That document
referenced a summary of the petition prepared by K-I Chemical USA,
Inc., the registrant, which is available in the docket, https://www.regulations.gov. No comments were received in response to the
notice of filing.
Because the January 26, 2018, document identified the K-I Chemical
petition by the wrong petition number, EPA published another document
in the Federal Register assigning the correct petition number to the K-
I Chemical petition--PP6F8521. That document was published in the
Federal Register on March 15, 2018 (83 FR 11448) (FRL-9974-72). No
relevant comments were received on the notice of filing.
Based upon review of the data supporting the petition, EPA has
modified the levels at which some of the tolerances are being
established and also modified some of the crop definitions. The reasons
for these changes are explained in Unit IV.C.
III. Aggregate Risk Assessment and Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
.''
Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for pyroxasulfone including
exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with pyroxasulfone
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.
The toxicology database for pyroxasulfone is adequate for
evaluating and characterizing toxicity and selecting endpoints for
purposes of this risk assessment. Pyroxasulfone acute toxicity to
mammals is low by all routes of exposure. Subchronic and chronic oral
studies in mice, rats and dogs produced a variety of effects including
cardiac toxicity (increased cardiomyopathy), liver toxicity
(centrilobular hepatocellular hypertrophy, histopathological and/or
clinical pathological indicators), kidney toxicity (nephropathy),
neurotoxicity (impaired hind limb function, ataxia, tremors, sciatic
nerve lesions, axonal/myelin degeneration in the sciatic nerve and
spinal cord sections), skeletal muscle myopathy, urinary bladder
mucosal hyperplasia, and urinary bladder transitional cell papillomas.
Minimal to mild cardiac myofiber degeneration and local inflammation
were also seen in a rat dermal toxicity study. Neurotoxicity was also
seen in a developmental neurotoxicity study in rats (decreased brain
weight, decreased thickness of the hippocampus, corpus callosum and
cerebellum in offspring). Dogs appear to be the most sensitive species
to the neurotoxic effects of pyroxasulfone. Immunotoxicity studies in
rats and mice show no evidence of immunotoxic effects from
pyroxasulfone.
There is evidence of fetal and offspring susceptibility in the
developmental neurotoxicity study in rats as effects occurred in the
absence of maternal toxicity. There is no concern for reproductive
toxicity. Pyroxasulfone is classified as ``Not Likely to be
Carcinogenic to Humans'' at doses that do not cause crystals with
subsequent calculi formation resulting in cellular damage of the
urinary tract. The Agency has determined that the quantification
[[Page 22856]]
of risk using a non-linear approach (i.e., reference dose (RfD)) will
adequately account for all chronic toxicity, including carcinogenicity,
that could result from exposure to pyroxasulfone.
Specific information on the studies received and the nature of the
adverse effects caused by pyroxasulfone as the no-observed-adverse
effect level (NOAEL) and lowest-observed adverse effect level (LOAEL)
from the toxicity studies can be found at https://www.regulations.gov in
document ``Pyroxasulfone Human Health Risk Assessment for the Section 3
New Uses of Pyroxasulfone on Crop Subgroup 1C, tuberous and corm
vegetables and Crop Group 3-07, bulb vegetables'' at pages 39-53 in
docket ID number EPA-HQ-OPP-2015-0787.
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 the NOAEL and the LOAEL are identified.
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 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 use https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
A summary of the toxicological endpoints for pyroxasulfone used for
human risk assessment is shown in the Table 1 of this unit.
Table 1--Toxicological Doses and Endpoints for Pyroxasulfone for Use in Dietary Human Health Risk Assessments
----------------------------------------------------------------------------------------------------------------
Point of Uncertainty/ FQPA Study and
Exposure/scenario departure safety factors RfD & PAD toxicological effects
----------------------------------------------------------------------------------------------------------------
Acute Dietary (General NOAEL= 100 mg/kg. UFA= 10x......... Acute RfD = 1.0 Developmental
Population, including Infants UFH=10x.......... mg/kg. neurotoxicity study
and Children). FQPA SF=1x....... aPAD = 1.0 mg/kg. (DNT) in rats.
The LOAEL of 300 mg/kg/
day is based on
decreased brain
weight in both sexes,
reduced thickness of
the hippocampus,
corpus callosum and
cerebellum in
postnatal day (PND)
21 female offspring.
Chronic Dietary (All NOAEL= 2 mg/kg/ UFA= 10x......... Chronic RfD = One- year chronic dog
Populations). day. UFH=10x.......... 0.02 mg/kg/day. study
FQPA SF=1x....... cPAD = 0.02 mg/kg/ The LOAEL of 10 mg/kg/
day. day is based on
impaired hind limb
function, ataxia,
hind limb twitching
and tremors; clinical
pathology: increased
creatine kinase,
aspartate
aminotransferase;
axonal/myelin
degeneration of the
sciatic nerve and
spinal cord sections.
--------------------------------------------------------------------------------
Cancer (all routes)............ ``Not Likely to be Carcinogenic to Humans'' at doses that do not cause crystals
with subsequent calculi formation resulting in cellular damage of the urinary
tract. Risk is quantified using a non-linear (i.e., RfD) approach.
----------------------------------------------------------------------------------------------------------------
Point of Departure (POD) = A data point or an estimated point that is derived from observed dose-response data
and used to mark the beginning of extrapolation to determine risk associated with lower environmentally
relevant human exposures. NOAEL = no observed adverse effect level. LOAEL = lowest observed adverse effect
level. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential
variation in sensitivity among members of the human population (intraspecies). FQPA SF = FQPA Safety Factor.
PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. MOE = margin of exposure. LOC =
level of concern. N/A = not applicable.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to pyroxasulfone, EPA considered exposure under the
petitioned-for tolerances as well as all existing pyroxasulfone
tolerances in 40 CFR 180.659. EPA assessed dietary exposures from
pyroxasulfone 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.
Such effects were identified for pyroxasulfone. In estimating acute
dietary exposure, EPA used food consumption data from the United States
Department of Agriculture (USDA) 2003-2008 National Health and
Nutrition Examination Survey/What We Eat in America (NHANES/WWEIA). As
to residue levels in food, EPA assumed 100 percent crop treated (PCT)
and tolerance-level residues adjusted for metabolites which are not in
the tolerance expression.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA 2003-2008
(NHANES/WWEIA). As to residue levels in food, EPA assumed 100 PCT and
tolerance-level residues adjusted for metabolites which are not in the
tolerance expression.
iii. Cancer. Based on the data summarized in Unit III.A., EPA has
classified pyroxasulfone as ``Not Likely to be Carcinogenic to Humans''
at doses that do not cause crystals with subsequent calculi formation
resulting in cellular damage of the urinary tract. The Agency has
determined that the quantification of risk using a non-linear approach
(i.e., RfD) will adequately account for all chronic toxicity, including
carcinogenicity, that could result from exposure to pyroxasulfone.
iv. Anticipated residue and percent crop treated (PCT) information.
EPA did not use anticipated residue and PCT information in the dietary
assessment for pyroxasulfone. Tolerance-level residues and 100% crop
treated (CT) 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 pyroxasulfone in drinking water. These simulation models
take into
[[Page 22857]]
account data on the physical, chemical, and fate/transport
characteristics of pyroxasulfone. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at at https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-riskpesticides.
Based on the Pesticide Root Zone Model Ground Water (PRZM version
3.122)/Exposure Analysis Modeling System-Superseded (EXAMS version
2.98.04), the estimated concentrations of pyroxasulfone in surface
water were minimal, and the highest estimated drinking water
concentrations (EDWCs) of pyroxasulfone residues were from a Tier II
PRZM-GW modeling at an application rate of 0.267 lbs active ingredient/
Acre for registered crops. The same EDWCs have been used for the
current human health dietary risk assessment. The EDWCs for peak
concentration (used in the acute assessment) and 30-year average
concentration (used in the chronic assessment) were 0.210 and 0.174 mg/
L (ppm), respectively. Water residues were incorporated in the Dietary
Exposure Evaluation Model--Food Commodity Intake Database (DEEM-FCID)
into the food categories ``water, direct, all sources'' and ``water,
indirect, all sources.''
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).
Pyroxasulfone is not registered for any specific use patterns that
would result in residential exposure.
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
EPA has not found pyroxasulfone to share a common mechanism of
toxicity with any other substances, and pyroxasulfone does not appear
to produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
pyroxasulfone does not have a common mechanism of toxicity with other
substances. For information regarding EPA's efforts to determine which
chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see EPA's website at https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-riskpesticides.
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 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. Pyroxasulfone did not
exhibit developmental toxicity in the rat guideline study at the limit
dose of 1,000 mg/kg/day and it exhibited slight developmental toxicity
in rabbits (reduced fetal weight and resorptions) at the limit dose of
1,000 mg/kg/day. However, developmental effects were noted in offspring
at 300 mg/kg/day in the rat DNT study characterized as decreased brain
weight and morphometric changes. Developmental effects in the rabbit
developmental study and DNT study occurred in the absence of maternal
toxicity, indicating potential increased quantitative susceptibility of
offspring. In a rat reproductive toxicity study, reduced pup weight and
body weight gains during lactation occurred at similar doses causing
pronounced maternal toxicity (reduced body weight, body weight gain and
food consumption and increased kidney weight, cardiomyopathy and
urinary bladder mucosal hyperplasia with inflammation).
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 pyroxasulfone is complete.
ii. Available data indicates that pyroxasulfone produces neurotoxic
effects in rats. The toxicity database includes specific acute and
subchronic neurotoxicity tests, as well as a DNT study. Although the
DNT indicated offspring are more sensitive to neurotoxic effects of
pyroxasulfone, the dose-response is well characterized for
neurotoxicity and a NOAEL is identified; therefore, there is no
residual uncertainty with regard to neurotoxic effects for which a 10X
must be retained.
iii. Evidence of increased susceptibility of fetuses and offspring
was seen in a DNT study in rats and a developmental study in rabbits
following in utero or post-natal exposure to pyroxasulfone. However, no
susceptibility was seen in the rat developmental or reproduction
studies. In rabbits, developmental toxicity was only seen at the limit
dose of 1000 mg/kg/day as reduced fetal weight and increased fetal
resorptions with a NOAEL of 500 mg/kg/day for these effects, compared
to no maternal toxicity at these doses. In a DNT study in rats,
offspring toxicity was seen at 300 mg/kg/day compared to no maternal
toxicity at 900 mg/kg/day. This increased susceptibility is occurring
at high doses. NOAELs and LOAELs have been identified for all effects
of concern and thus, a clear dose response has been well defined.
Therefore, residual uncertainties or concerns for pre- and/or post-
natal toxicity are minimal, and EPA concludes that reducing the FQPA
safety factor to 1X will be protective of such effects.
iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100% CT and tolerance-level residues. EPA made conservative
(protective) assumptions in the ground and surface water modeling used
to assess exposure to pyroxasulfone in drinking water. These
assessments will not underestimate the exposure and risks posed by
pyroxasulfone.
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 population adjusted dose (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. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to
[[Page 22858]]
pyroxasulfone will occupy 3.7% of the aPAD for all infants less than 1-
year old, the population group receiving the greatest exposure.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
pyroxasulfone from food and water will utilize 50% of the cPAD for all
infants less than 1-year old, the population group receiving the
greatest exposure.
3. Short-term and intermediate-term risk. Short-term and
intermediate-term aggregate exposure takes into account short-term and
intermediate-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).
Although short-term and intermediate-term adverse effects were
identified, pyroxasulfone is not registered for any use patterns that
would result in residential exposure. Therefore, EPA relies on the
chronic dietary risk assessment for evaluating short-term and
intermediate-term risk for pyroxasulfone.
4. Aggregate cancer risk for U.S. population. As explained in Unit
III.A., the Agency has determined that the quantification of risk using
a non-linear (i.e., RfD) approach will adequately account for all
chronic toxicity, including carcinogenicity, that could result from
exposure to pyroxasulfone. Therefore, based on the results of the
chronic risk assessment discussed in Unit III.E.2., pyroxasulfone is
not expected to pose a cancer risk to humans.
5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to pyroxasulfone residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (high performance liquid
chromatography/triple quadrupole mass spectrometry (LC/MS/MS) methods)
are available to enforce the tolerance expression.
These methods may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD
20755-5350; telephone number: (410) 305-2905; email address:
[email protected].
B. International Residue Limits
In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level. The Codex has not
established a MRL for pyroxasulfone in any of the proposed commodities.
C. Revisions to Petitioned-For Tolerances
The vegetable, tuberous and corm, subgroup 1C tolerance is being
established at 0.08 ppm instead of 0.05 ppm. The petitioner's requested
tolerance level included only residues from the parent and M1
metabolite. The Agency is establishing this tolerance at 0.08 ppm to
account for the measurement of parent and four metabolites. Applying
processing factors in accordance with the Agency's policy for
determining such factors when measuring multiple pesticide residues,
the Agency has determined that 0.20 ppm is an appropriate tolerance
level for granules/flakes. In addition, The Agency has determined that
a tolerance for potato chips is not required because residues will be
within the tolerance level established for subgroup 1C.
V. Conclusion
Therefore, tolerances are established for residues of pyroxasulfone
including its metabolites and degradates, in or on potatoes, granules/
flakes at 0.20 ppm; vegetable, bulb, group 3-07 at 0.15 ppm; and
vegetable, tuberous and corm, subgroup 1C at 0.08 ppm.
VI. Statutory and Executive Order Reviews
This action establishes tolerances under FFDCA section 408(d) in
response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this action has been
exempted from review under Executive Order 12866, this action is not
subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001); Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997); or Executive Order 13771,
entitled ``Reducing Regulations and Controlling Regulatory Costs'' (82
FR 9339, February 3, 2017). This action does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This action directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply 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).
[[Page 22859]]
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: May 8, 2018.
Daniel 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. In Sec. 180.659, add alphabetically ``Potato, granules/flakes'',
``Vegetable, bulb, group 3-07'', and ``Vegetable, tuberous and corm,
subgroup 1C'' to the table in paragraph (a)(5) to read as follows:
Sec. 180.659 Pyroxasulfone; tolerances for residues.
(a) * * *
(5) * * *
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Potato, granules/flakes..................................... 0.20
* * * * *
Vegetable, bulb, group 3-07................................. 0.15
* * * * *
Vegetable, tuberous and corm, subgroup 1C................... 0.08
------------------------------------------------------------------------
* * * * *
[FR Doc. 2018-10582 Filed 5-16-18; 8:45 am]
BILLING CODE 6560-50-P
