Chlorfenapyr; Pesticide Tolerances, 3605-3610 [2018-01487]
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Federal Register / Vol. 83, No. 18 / Friday, January 26, 2018 / Rules and Regulations
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acid that may be used, this limitation
has no effect for an exemption based
only on the related calcium salts of
phosphorous acid, which have been
considered as a distinct fungicide,
although it is related to all the other
salts of phosphorous acid. In any case,
residues of calcium salts of
phosphorous acid are considered to be
covered for all post-harvest uses without
numerical limitation, including those on
potatoes.
IV. Statutory and Executive Order
Reviews
This action establishes a tolerance
exemption under FFDCA section 408(d)
in response to a petition submitted to
EPA. 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); nor is it considered a
regulatory action under 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 exemption in this action,
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. As a result,
this action does not alter the
relationships or distribution of power
and responsibilities established by
Congress in the preemption provisions
of FFDCA section 408(n)(4). As such,
EPA has determined that this action will
not have a substantial direct effect on
States or tribal governments, on the
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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, EPA 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
EPA’s 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).
V. Congressional Review Act
Pursuant to the Congressional Review
Act (5 U.S.C. 801 et seq.), EPA will
submit a report containing this rule and
other required information to the U.S.
Senate, the U.S. House of
Representatives, and the Comptroller
General of the United States prior to
publication of the rule in the Federal
Register. This action is not a ‘‘major
rule’’ as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: January 5, 2018.
Richard P. Keigwin, Jr.,
Director, 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. Revise § 180.1210 to read as
follows:
■
§ 180.1210 Phosphorous acid; exemption
from the requirement of a tolerance.
(a) An exemption from the
requirement of a tolerance is established
for residues of phosphorous acid and its
ammonium, sodium and potassium salts
in or on all food commodities when
used as an agricultural fungicide and in
or on potatoes when applied as a post-
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3605
harvest treatment at 35,600 ppm or less
phosphorous acid.
(b) An exemption from the
requirement of a tolerance is established
for residues of calcium salts of
phosphorous acid, including its
metabolites and degradates, in or on all
food commodities when used as a
fungicide or as a systemic acquired
resistance (SAR) inducer.
[FR Doc. 2018–01494 Filed 1–25–18; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2016–0333; FRL–9970–88]
Chlorfenapyr; Pesticide Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes
tolerances for residues of chlorfenapyr,
4-bromo-2-(4-chlorophenyl)-1(ethoxymethyl)-5-(trifluromethyl)-1Hpyrrole-3-carbonitrile, in or on tea,
dried. BASF Corporation requested
these tolerances under the Federal Food,
Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective
January 26, 2018. Objections and
requests for hearings must be received
on or before March 27, 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–2016–0333, 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 (750P), Office of
Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania
Ave. NW, Washington, DC 20460–0001;
SUMMARY:
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main telephone number: (703) 305–
7090; email address: RDFRNotices@
epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by
this action if you are an agricultural
producer, food manufacturer, or
pesticide manufacturer. The following
list of North American Industrial
Classification System (NAICS) codes is
not intended to be exhaustive, but rather
provides a guide to help readers
determine whether this document
applies to them. Potentially affected
entities may include:
• Crop production (NAICS code 111).
• Animal production (NAICS code
112).
• Food manufacturing (NAICS code
311).
• Pesticide manufacturing (NAICS
code 32532).
B. How can I get electronic access to
other related information?
You may access a frequently updated
electronic version of EPA’s tolerance
regulations at 40 CFR part 180 through
the Government Printing Office’s e-CFR
site at https://www.ecfr.gov/cgi-bin/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/
40tab_02.tpl.
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C. How can I file an objection or hearing
request?
Under FFDCA section 408(g), 21
U.S.C. 346a, any person may file an
objection to any aspect of this regulation
and may also request a hearing on those
objections. You must file your objection
or request a hearing on this regulation
in accordance with the instructions
provided in 40 CFR part 178. To ensure
proper receipt by EPA, you must
identify docket ID number EPA–HQ–
OPP–2016–0333 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 March 27, 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
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by docket ID number EPA–HQ–OPP–
2016–0333, 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 July 20,
2016 (81 FR 47150) (FRL–9948–45),
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 6E8473) by BASF
Corporation, 26 Davis Drive, Research
Triangle Park, NC 27709. The petition
requested that 40 CFR 180.513 be
amended by establishing tolerances for
residues of the insecticide chlorfenapyr,
4-bromo-2-(4-chlorophenyl)-1(ethoxymethyl)-5-(trifluromethyl)-1Hpyrrole-3-carbonitrile, in or on tea, dried
at 70 parts per million (ppm). That
document referenced a summary of the
petition prepared by BASF Corporation,
the registrant, which is available in the
docket, https://www.regulations.gov.
This tolerance was requested to cover
residues of chlorfenapyr in or on tea
resulting from uses of this pesticide on
tea outside the United States. There is
no current U.S. registration for use of
chlorfenapyr on tea. In addition, there
were no substantive comments received
in response to the notice of filing.
III. Aggregate Risk Assessment and
Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA
allows EPA to establish a tolerance (the
legal limit for a pesticide chemical
residue in or on a food) only if EPA
determines that the tolerance is ‘‘safe.’’
Section 408(b)(2)(A)(ii) of FFDCA
defines ‘‘safe’’ to mean that ‘‘there is a
reasonable certainty that no harm will
result from aggregate exposure to the
pesticide chemical residue, including
all anticipated dietary exposures and all
other exposures for which there is
reliable information.’’ This includes
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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 chlorfenapyr
including exposure resulting from the
tolerances established by this action.
EPA’s assessment of exposures and risks
associated with chlorfenapyr 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. Chlorfenapyr has
moderate acute toxicity via the oral
route of exposure and low acute toxicity
via the dermal and inhalation routes of
exposure. It is a mild eye irritant, but it
is not a dermal irritant or sensitizer.
Chlorfenapyr targets the central nervous
system (CNS), inducing
neurohistological changes (spongiform
myelinopathy of the brain and spinal
cord and vacuolization of the brain,
spinal cord, and optic nerve) from
subchronic and chronic dietary
administration in mice and rats. In
addition to neuropathology, rats also
exhibited neurobehavioral changes on
the day of dosing in the acute
neurotoxicity study. Decreased motor
activity was observed in the acute
neurotoxicity study as well as in
offspring in the developmental
neurotoxicity (DNT) study. Several rat
studies also noted effects in the liver
(increased organ weights and tumors) at
doses similar to or above those where
CNS effects were seen. The liver was
identified in metabolism studies as the
single organ to have the highest
recovery of administered dose.
There was evidence of increased
quantitative susceptibility to offspring
in the database as a result of
chlorfenapyr exposure. In the two-
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generation reproduction study,
decreased pup weights were seen at a
lower dose than parental toxicity
(decreased body-weight). In the DNT
study, offspring toxicity (decreased
motor activity and increased pup deaths
on postnatal days 1–4) was seen in the
absence of maternal toxicity. Additional
effects on the CNS (vacuolation of white
matter in the brain and decreased
hippocampus size) were also observed
in offspring at a higher dose in this
study. There was no evidence of
increased susceptibility to offspring in
the developmental toxicity studies. In
both the rat and rabbit developmental
toxicity studies, although no maternal or
developmental effects were noted up to
the highest doses tested (HDT), maternal
observations are limited in these
developmental studies. Consequently,
the data from the DNT are considered
more robust for assessing the effects of
chlorfenapyr on the nervous system.
Given the lack of toxicity in the rat
and rabbit developmental studies, the
early pup deaths in the reproduction
toxicity and DNT studies are suspected
to be the result of postnatal exposure
through lactation. Chlorfenapyr has a
relatively high octanol-water partition
coefficient (log KOW = 4.83) and has
been shown to accumulate in milk due
to its lipophilic nature in a dietary cow
study. In addition, in a rat metabolism
study, chlorfenapyr was found to
accumulate in the fat, such that females
exhibited greater accumulation than
males. This suggests chlorfenapyr is
capable of accumulating in breast milk
and likely causing the early pup deaths
seen in the reproduction toxicity and
DNT studies through lactation.
Chlorfenapyr did not show any
evidence of mutagenicity in in vitro or
in vivo studies. Chlorfenapyr is
classified as ‘‘suggestive evidence of
carcinogenicity, but not sufficient to
assess human carcinogenic potential.’’
Specific information on the studies
received and the nature of the adverse
effects caused by chlorfenapyr 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 in the document
entitled ‘‘Chlorfenapyr: Revised
Preliminary Human Health Risk
Assessment for Registration Review,’’
dated September 7, 2016, which can be
found in docket ID number EPA–HQ–
OPP–2010–0467 as well in the
document completed in support of this
tolerance action entitled ‘‘Chlorfenapyr.
Human Health Risk Assessment for the
Establishment of a Tolerance without a
U.S. Registration for Residues in/on
Imported Tea,’’ dated March 1, 2017,
which can be found in docket ID
number EPA–HQ–OPP–2016–0333.
B. Toxicological Points of Departure/
Levels of Concern
Once a pesticide’s toxicological
profile is determined, EPA identifies
3607
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 chlorfenapyr
used for human risk assessment is
shown in Table 1 of this unit.
TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR CHLORFENAPYR FOR USE IN HUMAN HEALTH RISK
ASSESSMENT
Point of departure
and uncertainty/
safety factors
RFD, PAD, LOC for
risk assessment
Study and toxicological effects
Acute Dietary (All populations)
NOAEL = 5 mg/kg/
day.
UFA = 10X
UFH = 10X
FQPA SF = 1X
Acute RfD = 0.05
mg/kg/day.
aPAD = 0.05 mg/kg/
day
Developmental Neurotoxicity Study (Rat).
LOAEL = 10 mg/kg/day based on increased pup deaths (postnatal days 1–4) and decreased motor activity.
Chronic Dietary (All populations).
NOAEL = 5 mg/kg/
day.
UFA = 10X
UFH = 10X
FQPA SF = 1X
Chronic RfD = 0.05
mg/kg/day.
cPAD = 0.05 mg/kg/
day.
Developmental Neurotoxicity Study (Rat).
LOAEL = 10 mg/kg/day based on increased pup deaths (postnatal days 1–4) and decreased motor activity.
Chronic Neurotoxicity Study (Rat).
NOAEL = 2.6 mg/kg/day.
LOAEL = 13.6 mg/kg/day based on alterations of the myelin of
the CNS and decreased water consumption in male rats, decreased food consumption in females, and decreased bodyweight in both sexes.
Incidental Oral Short-Term (1–
30 days) and IntermediateTerm (1–6 months).
NOAEL = 5 mg/kg/
day.
UFA = 10X
UFH = 10X
FQPA SF = 1X
Residential LOC for
MOE = 100.
Developmental Neurotoxicity Study (Rat).
LOAEL = 10 mg/kg/day based on increased pup deaths (postnatal days 1–4) and decreased motor activity.
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Exposure/scenario
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TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR CHLORFENAPYR FOR USE IN HUMAN HEALTH RISK
ASSESSMENT—Continued
Exposure/scenario
Point of departure
and uncertainty/
safety factors
RFD, PAD, LOC for
risk assessment
Study and toxicological effects
Dermal Short-Term (1–30 days)
and Intermediate-Term (1–6
months).
NOAEL = 5 mg/kg/
day.
UFA = 10X
UFH = 10X
FQPA SF = 1X
Residential LOC for
MOE = 100.
Developmental Neurotoxicity Study (Rat).
LOAEL = 10 mg/kg/day based on increased pup deaths (postnatal days 1–4) and decreased motor activity.
Inhalation Short-Term (1–30
days) and Intermediate-Term
(1–6 months).
NOAEL = 5 mg/kg/
day.
UFA = 10X
UFH = 10X
FQPA SF = 1X
Residential LOC for
MOE = 100.
Developmental Neurotoxicity Study (Rat).
LOAEL = 10 mg/kg/day based on increased pup deaths (postnatal days 1–4) and decreased motor activity.
Cancer (oral, dermal, inhalation).
Classified as ‘‘suggestive evidence of carcinogenicity, but not sufficient to assess human carcinogenic potential.’’ The Agency determined that quantification of risk using a non-linear approach (i.e., using a cRfD) adequately accounts for all chronic toxicity, including carcinogenicity that could result from exposure to
chlorfenapyr.
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.
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C. Exposure Assessment
1. Dietary exposure from food and
feed uses. In evaluating dietary
exposure to chlorfenapyr, EPA
considered exposure under the
petitioned-for tolerances as well as all
existing chlorfenapyr tolerances in 40
CFR 180.513. EPA assessed dietary
exposures from chlorfenapyr 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 chlorfenapyr. In estimating acute
dietary (food only) exposure, EPA used
the Dietary Exposure Evaluation
Model—Food Consumption Intake
Database (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’s acute analysis was unrefined and
used tolerance-level residues and 100%
crop-treated (PCT). Tolerances for food/
feed handling establishments are not
included in the acute dietary assessment
unless the food/feed handling
establishment is the only use; however,
this is not the case for chlorfenapyr.
DEEM 7.81 default processing factors
were used in the acute analysis for
tomato commodities as there is a
registered agricultural use on fruiting
vegetables.
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ii. Chronic exposure. In conducting
the chronic dietary (food only) risk
assessment, EPA used the DEEM–FCID,
Version 3.16, which uses food
consumption data from the U.S.
Department of Agriculture’s NHANES/
WWEIA from 2003–2008. As to residue
levels in food, EPA’s chronic dietary
exposure analysis for the all population
subgroups was unrefined and used
tolerance-level residues and 100% PCT.
As most tolerances for chlorfenapyr are
for food or feed handling establishment
uses and residues are expected to be
incurred after processing, DEEM 7.81
processing factors were set to 1 for all
commodities except tomato
commodities (as there is a registered
agricultural use on fruiting vegetables).
For tomato commodities, default
processing factors were used in the
analysis.
iii. Cancer. EPA determines whether
quantitative cancer exposure and risk
assessments are appropriate for a fooduse pesticide based on the weight of the
evidence from cancer studies and other
relevant data. Cancer risk is quantified
using a linear or nonlinear approach. If
sufficient information on the
carcinogenic mode of action is available,
a threshold or nonlinear approach is
used and a cancer RfD is calculated
based on an earlier noncancer key event.
If carcinogenic mode of action data are
not available, or if the mode of action
data determines a mutagenic mode of
action, a default linear cancer slope
factor approach is utilized. Based on the
data summarized in Unit III.A., EPA has
concluded that a nonlinear approach
using the chronic RfD for assessing
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cancer risk is appropriate for
chlorfenapyr; therefore, a separate
quantitative cancer risk assessment is
unnecessary.
iv. Anticipated residue and percent
crop treated (PCT) information. EPA did
not use anticipated residue and/or PCT
information in the dietary assessment
for chlorfenapyr. Tolerance level
residues and/or 100% CT were assumed
for all food commodities.
2. Dietary exposure from drinking
water. The acute and chronic dietary
analysis did not include exposure from
drinking water as contamination of
drinking water with chlorfenapyr as a
result of all registered uses, including
greenhouses, is not expected to occur.
Furthermore, as there are no U.S.
registrations for tea, a dietary exposure
assessment from drinking water is not
needed.
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).
Chlorfenapyr is currently registered for
the following uses that could result in
residential exposures: crack/crevice/
spot treatment on indoor and outdoor
residential sites (including as a bed bug
treatment). Residential exposures are
not expected to occur from use of
chlorfenapyr on tea since chlorfenapyr
will not be applied to tea in the United
States. Further information regarding
EPA standard assumptions and generic
inputs for residential exposures may be
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D. Safety Factor for Infants and
Children
ii. Although the central nervous
system is the primary target for
chlorfenapyr and neurotoxic effects
were observed across studies, concern is
low since the selected PODs are
protective of observed neurotoxic
effects.
iii. Although there is evidence of
increased quantitative susceptibility,
concern is low since the offspring
effects are well-characterized with
clearly established NOAEL/LOAEL
values and the endpoints selected for
risk assessment are protective of
observed offspring effects.
iv. There are no residual uncertainties
identified in the exposure databases.
The acute and chronic analysis did not
include exposure from drinking water as
contamination of drinking water with
chlorfenapyr as the result of all
registered uses, including greenhouses,
is not expected to occur. Furthermore,
as there is no U.S. registration for tea,
a dietary exposure assessment from
drinking water is not needed. 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 chlorfenapyr.
1. In general. Section 408(b)(2)(C) of
FFDCA provides that EPA shall apply
an additional tenfold (10X) margin of
safety for infants and children in the
case of threshold effects to account for
prenatal and postnatal toxicity and the
completeness of the database on toxicity
and exposure unless EPA determines
based on reliable data that a different
margin of safety will be safe for infants
and children. This additional margin of
safety is commonly referred to as the
FQPA Safety Factor (SF). In applying
this provision, EPA either retains the
default value of 10X, or uses a different
additional safety factor when reliable
data available to EPA support the choice
of a different factor.
2. Prenatal and postnatal sensitivity.
Although there is evidence of increased
quantitative susceptibility, concern is
low since the offspring effects are wellcharacterized with clearly established
NOAEL/LOAEL values and the
endpoints selected for risk assessment
are protective of observed offspring
effects, including those observed in
lactating pups.
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
chlorfenapyr is complete.
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 the acute
exposure assumptions discussed in this
unit for acute exposure, the resulting
acute (food only) risk estimates were
less than EPA’s LOC (<100% of the
aPAD) for the general U.S. population
(15% of the aPAD) and all population
subgroups. The most highly exposed
population subgroup was children 1 to
2 years old with an estimated equivalent
risk to 36% of the aPAD; therefore, the
acute dietary exposure to chlorfenapyr
is below the Agency’s LOC.
2. Chronic risk. Using the exposure
assumptions described in this unit for
chronic exposure, EPA has concluded
that the resulting chronic risk estimate
utilizes 4.6% of the cPAD for the
general U.S. population. The most
daltland on DSKBBV9HB2PROD with RULES
found at https://www.epa.gov/pesticides/
trac/science/trac6a05.pdf.
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 chlorfenapyr to
share a common mechanism of toxicity
with any other substances, and
chlorfenapyr does not appear to produce
a toxic metabolite produced by other
substances. For the purposes of this
tolerance action, therefore, EPA has
assumed that chlorfenapyr 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/pesticides/cumulative.
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3609
highly-exposed population subgroup
was children 1 to 2 years old which
utilized 9.9% of the cPAD; therefore, the
chronic dietary exposure to
chlorfenapyr for all population
subgroups is below the Agency’s LOC.
Based on the explanation in Unit
III.C.3., regarding residential use
patterns, chronic residential exposure to
residues of chlorfenapyr is not expected.
3. Short- and Intermediate-term risk.
Short- and intermediate-term aggregate
risk assessments were performed since
there is potential for post-application
exposure from the previously registered
uses of chlorfenapyr in residential
settings. Since the short- and
intermediate-term endpoints and PODs
are the same, the short-term aggregate
assessment is protective of intermediateterm exposure. The short-term aggregate
MOE of 840 for adults is greater than the
LOC (100), and is, therefore, not a
concern. For children (1 to <2 years
old), the most highly exposed
population subgroup, the short-term
aggregate MOE of 140 is greater than the
LOC (100), and is, therefore, not a
concern.
4. 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
chlorfenapyr will not pose a cancer risk.
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 chlorfenapyr
residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
The enforcement method is
designated as M 2427, a gas
chromatography/electron capture
detection (GC/ECD) method with a limit
of quantitation (LOQ) of 0.05 ppm.
Method M 2427 has been subjected to a
successful independent laboratory
validation (ILV) as well as an acceptable
radiovalidation using samples obtained
from lettuce and tomato metabolism
studies. This method is adequate for
data collection and tolerance
enforcement purposes.
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
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Federal Register / Vol. 83, No. 18 / Friday, January 26, 2018 / Rules and Regulations
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 chlorfenapyr in or
on tea, dried.
C. Revisions to Petitioned-for Tolerances
EPA is establishing a tolerance for
‘‘tea, dried’’, as opposed to ‘‘tea’’ as
requested by the petitioner, for
consistency with the Agency’s food and
feed commodity vocabulary. In
addition, EPA is amending the
introductory text of paragraph (a)(1) to
be consistent with the Agency’s policy
for drafting the tolerance expression.
These revisions reflect the language in
FFDCA section 408(a)(3), which
includes metabolites and degradates of
a pesticide chemical under the same
tolerance unless otherwise excluded, as
well as providing greater clarity for
measuring residues to determine
compliance. These revisions do not
substantively change the existing
tolerances in paragraph (a)(3).
daltland on DSKBBV9HB2PROD with RULES
V. Conclusion
Therefore, a tolerance is established
without U.S. registrations for residues of
chlorfenapyr, 4-bromo-2-(4-chloro
phenyl)-1-(ethoxymethyl)-5-(trifluro
methyl)-1H-pyrrole-3-carbonitrile, in or
on tea, dried at 70 parts per million.
VI. Statutory and Executive Order
Reviews
This action establishes a 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); Executive
Order 13045, entitled ‘‘Protection of
VerDate Sep<11>2014
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Jkt 244001
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).
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
PO 00000
Frm 00048
Fmt 4700
Sfmt 4700
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: December 18, 2017.
Michael Goodis,
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 § 180.513, revise paragraph (a)(1)
to read as follows:
■
§ 180.513 Chlorfenapyr; tolerances for
residues.
(a) General. (1) Tolerances are
established for residues of chlorfenapyr,
including its metabolites and
degradates, in or on the commodities in
the table below. Compliance with the
tolerance levels specified below is to be
determined by measuring only
chlorfenapyr, 4-bromo-2-(4chlorophenyl)-1-(ethoxymethyl)-5(trifluoromethyl)-1H-pyrrole-3carbonitrile, in or on the commodity.
Parts per
million
Commodity
Tea, dried 1 .................................
Vegetable, fruiting, group 8–10 ..
70
1.0
1 There are no U.S. registrations for Tea,
dried as of January 26, 2018.
*
*
*
*
*
[FR Doc. 2018–01487 Filed 1–25–18; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2017–0498; FRL–9971–94]
Flonicamid; Pesticide Tolerances for
Emergency Exemptions
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes
time-limited tolerances for residues of
SUMMARY:
E:\FR\FM\26JAR1.SGM
26JAR1
Agencies
[Federal Register Volume 83, Number 18 (Friday, January 26, 2018)]
[Rules and Regulations]
[Pages 3605-3610]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-01487]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2016-0333; FRL-9970-88]
Chlorfenapyr; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes tolerances for residues of
chlorfenapyr, 4-bromo-2-(4-chlorophenyl)-1-(ethoxymethyl)-5-
(trifluromethyl)-1H-pyrrole-3-carbonitrile, in or on tea, dried. BASF
Corporation requested these tolerances under the Federal Food, Drug,
and Cosmetic Act (FFDCA).
DATES: This regulation is effective January 26, 2018. Objections and
requests for hearings must be received on or before March 27, 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-2016-0333, 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 (750P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460-0001;
[[Page 3606]]
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-2016-0333 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
March 27, 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-2016-0333, 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 July 20, 2016 (81 FR 47150) (FRL-9948-
45), 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
6E8473) by BASF Corporation, 26 Davis Drive, Research Triangle Park, NC
27709. The petition requested that 40 CFR 180.513 be amended by
establishing tolerances for residues of the insecticide chlorfenapyr,
4-bromo-2-(4-chlorophenyl)-1-(ethoxymethyl)-5-(trifluromethyl)-1H-
pyrrole-3-carbonitrile, in or on tea, dried at 70 parts per million
(ppm). That document referenced a summary of the petition prepared by
BASF Corporation, the registrant, which is available in the docket,
https://www.regulations.gov. This tolerance was requested to cover
residues of chlorfenapyr in or on tea resulting from uses of this
pesticide on tea outside the United States. There is no current U.S.
registration for use of chlorfenapyr on tea. In addition, there were no
substantive comments received in response to the notice of filing.
III. Aggregate Risk Assessment and Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
.''
Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for chlorfenapyr including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with chlorfenapyr 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. Chlorfenapyr has moderate acute toxicity via the oral route
of exposure and low acute toxicity via the dermal and inhalation routes
of exposure. It is a mild eye irritant, but it is not a dermal irritant
or sensitizer. Chlorfenapyr targets the central nervous system (CNS),
inducing neurohistological changes (spongiform myelinopathy of the
brain and spinal cord and vacuolization of the brain, spinal cord, and
optic nerve) from subchronic and chronic dietary administration in mice
and rats. In addition to neuropathology, rats also exhibited
neurobehavioral changes on the day of dosing in the acute neurotoxicity
study. Decreased motor activity was observed in the acute neurotoxicity
study as well as in offspring in the developmental neurotoxicity (DNT)
study. Several rat studies also noted effects in the liver (increased
organ weights and tumors) at doses similar to or above those where CNS
effects were seen. The liver was identified in metabolism studies as
the single organ to have the highest recovery of administered dose.
There was evidence of increased quantitative susceptibility to
offspring in the database as a result of chlorfenapyr exposure. In the
two-
[[Page 3607]]
generation reproduction study, decreased pup weights were seen at a
lower dose than parental toxicity (decreased body-weight). In the DNT
study, offspring toxicity (decreased motor activity and increased pup
deaths on postnatal days 1-4) was seen in the absence of maternal
toxicity. Additional effects on the CNS (vacuolation of white matter in
the brain and decreased hippocampus size) were also observed in
offspring at a higher dose in this study. There was no evidence of
increased susceptibility to offspring in the developmental toxicity
studies. In both the rat and rabbit developmental toxicity studies,
although no maternal or developmental effects were noted up to the
highest doses tested (HDT), maternal observations are limited in these
developmental studies. Consequently, the data from the DNT are
considered more robust for assessing the effects of chlorfenapyr on the
nervous system.
Given the lack of toxicity in the rat and rabbit developmental
studies, the early pup deaths in the reproduction toxicity and DNT
studies are suspected to be the result of postnatal exposure through
lactation. Chlorfenapyr has a relatively high octanol-water partition
coefficient (log KOW = 4.83) and has been shown to
accumulate in milk due to its lipophilic nature in a dietary cow study.
In addition, in a rat metabolism study, chlorfenapyr was found to
accumulate in the fat, such that females exhibited greater accumulation
than males. This suggests chlorfenapyr is capable of accumulating in
breast milk and likely causing the early pup deaths seen in the
reproduction toxicity and DNT studies through lactation.
Chlorfenapyr did not show any evidence of mutagenicity in in vitro
or in vivo studies. Chlorfenapyr is classified as ``suggestive evidence
of carcinogenicity, but not sufficient to assess human carcinogenic
potential.''
Specific information on the studies received and the nature of the
adverse effects caused by chlorfenapyr 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 in the document entitled ``Chlorfenapyr: Revised
Preliminary Human Health Risk Assessment for Registration Review,''
dated September 7, 2016, which can be found in docket ID number EPA-HQ-
OPP-2010-0467 as well in the document completed in support of this
tolerance action entitled ``Chlorfenapyr. Human Health Risk Assessment
for the Establishment of a Tolerance without a U.S. Registration for
Residues in/on Imported Tea,'' dated March 1, 2017, which can be found
in docket ID number EPA-HQ-OPP-2016-0333.
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 chlorfenapyr used for human risk assessment is shown in
Table 1 of this unit.
Table 1--Summary of Toxicological Doses and Endpoints for Chlorfenapyr 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).. NOAEL = 5 mg/kg/day. Acute RfD = 0.05 mg/ Developmental Neurotoxicity Study
UFA = 10X........... kg/day. (Rat).
UFH = 10X........... aPAD = 0.05 mg/kg/ LOAEL = 10 mg/kg/day based on
FQPA SF = 1X........ day. increased pup deaths (post-natal
days 1-4) and decreased motor
activity.
------------------------------------------------------------------------------
Chronic Dietary (All populations) NOAEL = 5 mg/kg/day. Chronic RfD = 0.05 Developmental Neurotoxicity Study
UFA = 10X........... mg/kg/day. (Rat).
UFH = 10X........... cPAD = 0.05 mg/kg/ LOAEL = 10 mg/kg/day based on
FQPA SF = 1X........ day. increased pup deaths (post-natal
days 1-4) and decreased motor
activity.
Chronic Neurotoxicity Study (Rat).
NOAEL = 2.6 mg/kg/day.
LOAEL = 13.6 mg/kg/day based on
alterations of the myelin of the
CNS and decreased water
consumption in male rats,
decreased food consumption in
females, and decreased body-
weight in both sexes.
------------------------------------------------------------------------------
Incidental Oral Short-Term (1-30 NOAEL = 5 mg/kg/day. Residential LOC for Developmental Neurotoxicity Study
days) and Intermediate-Term (1-6 UFA = 10X........... MOE = 100. (Rat).
months). UFH = 10X........... LOAEL = 10 mg/kg/day based on
FQPA SF = 1X........ increased pup deaths (post-natal
days 1-4) and decreased motor
activity.
------------------------------------------------------------------------------
[[Page 3608]]
Dermal Short-Term (1-30 days) and NOAEL = 5 mg/kg/day. Residential LOC for Developmental Neurotoxicity Study
Intermediate-Term (1-6 months). UFA = 10X........... MOE = 100. (Rat).
UFH = 10X........... LOAEL = 10 mg/kg/day based on
FQPA SF = 1X........ increased pup deaths (post-natal
days 1-4) and decreased motor
activity.
------------------------------------------------------------------------------
Inhalation Short-Term (1-30 days) NOAEL = 5 mg/kg/day. Residential LOC for Developmental Neurotoxicity Study
and Intermediate-Term (1-6 UFA = 10X........... MOE = 100. (Rat).
months). UFH = 10X........... LOAEL = 10 mg/kg/day based on
FQPA SF = 1X........ increased pup deaths (post-natal
days 1-4) and decreased motor
activity.
------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation) Classified as ``suggestive evidence of carcinogenicity, but not sufficient to
assess human carcinogenic potential.'' The Agency determined that
quantification of risk using a non-linear approach (i.e., using a cRfD)
adequately accounts for all chronic toxicity, including carcinogenicity that
could result from exposure to chlorfenapyr.
----------------------------------------------------------------------------------------------------------------
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.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to chlorfenapyr, EPA considered exposure under the petitioned-
for tolerances as well as all existing chlorfenapyr tolerances in 40
CFR 180.513. EPA assessed dietary exposures from chlorfenapyr 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 chlorfenapyr. In estimating acute dietary (food only) exposure, EPA
used the Dietary Exposure Evaluation Model--Food Consumption Intake
Database (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's acute analysis was unrefined
and used tolerance-level residues and 100% crop-treated (PCT).
Tolerances for food/feed handling establishments are not included in
the acute dietary assessment unless the food/feed handling
establishment is the only use; however, this is not the case for
chlorfenapyr. DEEM 7.81 default processing factors were used in the
acute analysis for tomato commodities as there is a registered
agricultural use on fruiting vegetables.
ii. Chronic exposure. In conducting the chronic dietary (food only)
risk assessment, EPA used the DEEM-FCID, Version 3.16, which uses food
consumption data from the U.S. Department of Agriculture's NHANES/WWEIA
from 2003-2008. As to residue levels in food, EPA's chronic dietary
exposure analysis for the all population subgroups was unrefined and
used tolerance-level residues and 100% PCT. As most tolerances for
chlorfenapyr are for food or feed handling establishment uses and
residues are expected to be incurred after processing, DEEM 7.81
processing factors were set to 1 for all commodities except tomato
commodities (as there is a registered agricultural use on fruiting
vegetables). For tomato commodities, default processing factors were
used in the analysis.
iii. Cancer. EPA determines whether quantitative cancer exposure
and risk assessments are appropriate for a food-use pesticide based on
the weight of the evidence from cancer studies and other relevant data.
Cancer risk is quantified using a linear or nonlinear approach. If
sufficient information on the carcinogenic mode of action is available,
a threshold or nonlinear approach is used and a cancer RfD is
calculated based on an earlier noncancer key event. If carcinogenic
mode of action data are not available, or if the mode of action data
determines a mutagenic mode of action, a default linear cancer slope
factor approach is utilized. Based on the data summarized in Unit
III.A., EPA has concluded that a nonlinear approach using the chronic
RfD for assessing cancer risk is appropriate for chlorfenapyr;
therefore, a separate quantitative cancer risk assessment is
unnecessary.
iv. Anticipated residue and percent crop treated (PCT) information.
EPA did not use anticipated residue and/or PCT information in the
dietary assessment for chlorfenapyr. Tolerance level residues and/or
100% CT were assumed for all food commodities.
2. Dietary exposure from drinking water. The acute and chronic
dietary analysis did not include exposure from drinking water as
contamination of drinking water with chlorfenapyr as a result of all
registered uses, including greenhouses, is not expected to occur.
Furthermore, as there are no U.S. registrations for tea, a dietary
exposure assessment from drinking water is not needed.
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). Chlorfenapyr is
currently registered for the following uses that could result in
residential exposures: crack/crevice/spot treatment on indoor and
outdoor residential sites (including as a bed bug treatment).
Residential exposures are not expected to occur from use of
chlorfenapyr on tea since chlorfenapyr will not be applied to tea in
the United States. Further information regarding EPA standard
assumptions and generic inputs for residential exposures may be
[[Page 3609]]
found at https://www.epa.gov/pesticides/trac/science/trac6a05.pdf.
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 chlorfenapyr to share a common mechanism of
toxicity with any other substances, and chlorfenapyr does not appear to
produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
chlorfenapyr 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/pesticides/cumulative.
D. Safety Factor for Infants and Children
1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA Safety
Factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
factor.
2. Prenatal and postnatal sensitivity. Although there is evidence
of increased quantitative susceptibility, concern is low since the
offspring effects are well-characterized with clearly established
NOAEL/LOAEL values and the endpoints selected for risk assessment are
protective of observed offspring effects, including those observed in
lactating pups.
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 chlorfenapyr is complete.
ii. Although the central nervous system is the primary target for
chlorfenapyr and neurotoxic effects were observed across studies,
concern is low since the selected PODs are protective of observed
neurotoxic effects.
iii. Although there is evidence of increased quantitative
susceptibility, concern is low since the offspring effects are well-
characterized with clearly established NOAEL/LOAEL values and the
endpoints selected for risk assessment are protective of observed
offspring effects.
iv. There are no residual uncertainties identified in the exposure
databases. The acute and chronic analysis did not include exposure from
drinking water as contamination of drinking water with chlorfenapyr as
the result of all registered uses, including greenhouses, is not
expected to occur. Furthermore, as there is no U.S. registration for
tea, a dietary exposure assessment from drinking water is not needed.
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 chlorfenapyr.
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 the acute exposure assumptions discussed in this unit for acute
exposure, the resulting acute (food only) risk estimates were less than
EPA's LOC (<100% of the aPAD) for the general U.S. population (15% of
the aPAD) and all population subgroups. The most highly exposed
population subgroup was children 1 to 2 years old with an estimated
equivalent risk to 36% of the aPAD; therefore, the acute dietary
exposure to chlorfenapyr is below the Agency's LOC.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that the resulting chronic
risk estimate utilizes 4.6% of the cPAD for the general U.S.
population. The most highly-exposed population subgroup was children 1
to 2 years old which utilized 9.9% of the cPAD; therefore, the chronic
dietary exposure to chlorfenapyr for all population subgroups is below
the Agency's LOC. Based on the explanation in Unit III.C.3., regarding
residential use patterns, chronic residential exposure to residues of
chlorfenapyr is not expected.
3. Short- and Intermediate-term risk. Short- and intermediate-term
aggregate risk assessments were performed since there is potential for
post-application exposure from the previously registered uses of
chlorfenapyr in residential settings. Since the short- and
intermediate-term endpoints and PODs are the same, the short-term
aggregate assessment is protective of intermediate-term exposure. The
short-term aggregate MOE of 840 for adults is greater than the LOC
(100), and is, therefore, not a concern. For children (1 to <2 years
old), the most highly exposed population subgroup, the short-term
aggregate MOE of 140 is greater than the LOC (100), and is, therefore,
not a concern.
4. 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 chlorfenapyr will not pose a
cancer risk.
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 chlorfenapyr residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
The enforcement method is designated as M 2427, a gas
chromatography/electron capture detection (GC/ECD) method with a limit
of quantitation (LOQ) of 0.05 ppm. Method M 2427 has been subjected to
a successful independent laboratory validation (ILV) as well as an
acceptable radiovalidation using samples obtained from lettuce and
tomato metabolism studies. This method is adequate for data collection
and tolerance enforcement purposes.
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
[[Page 3610]]
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 chlorfenapyr in or
on tea, dried.
C. Revisions to Petitioned-for Tolerances
EPA is establishing a tolerance for ``tea, dried'', as opposed to
``tea'' as requested by the petitioner, for consistency with the
Agency's food and feed commodity vocabulary. In addition, EPA is
amending the introductory text of paragraph (a)(1) to be consistent
with the Agency's policy for drafting the tolerance expression. These
revisions reflect the language in FFDCA section 408(a)(3), which
includes metabolites and degradates of a pesticide chemical under the
same tolerance unless otherwise excluded, as well as providing greater
clarity for measuring residues to determine compliance. These revisions
do not substantively change the existing tolerances in paragraph
(a)(3).
V. Conclusion
Therefore, a tolerance is established without U.S. registrations
for residues of chlorfenapyr, 4-bromo-2-(4-chlorophenyl)-1-
(ethoxymethyl)-5-(trifluromethyl)-1H-pyrrole-3-carbonitrile, in or on
tea, dried at 70 parts per million.
VI. Statutory and Executive Order Reviews
This action establishes a 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); 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).
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: December 18, 2017.
Michael Goodis,
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. 180.513, revise paragraph (a)(1) to read as follows:
Sec. 180.513 Chlorfenapyr; tolerances for residues.
(a) General. (1) Tolerances are established for residues of
chlorfenapyr, including its metabolites and degradates, in or on the
commodities in the table below. Compliance with the tolerance levels
specified below is to be determined by measuring only chlorfenapyr, 4-
bromo-2-(4-chlorophenyl)-1-(ethoxymethyl)-5-(trifluoromethyl)-1H-
pyrrole-3-carbonitrile, in or on the commodity.
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Tea, dried \1\.............................................. 70
Vegetable, fruiting, group 8-10............................. 1.0
------------------------------------------------------------------------
\1\ There are no U.S. registrations for Tea, dried as of January 26,
2018.
* * * * *
[FR Doc. 2018-01487 Filed 1-25-18; 8:45 am]
BILLING CODE 6560-50-P