[Federal Register Volume 81, Number 233 (Monday, December 5, 2016)]
[Rules and Regulations]
[Pages 87456-87463]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-29111]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2015-0439; FRL-9954-33]
Tau-Fluvalinate; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes a tolerance for residues of tau-
fluvalinate in or on wine grapes. Makhteshim Agan of North America,
Inc., d/b/a ADAMA requested this tolerance under the Federal Food,
Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective December 5, 2016. Objections and
requests for hearings must be received on or before February 3, 2017,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2015-0439, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is (202) 566-1744, and the telephone number for the OPP
Docket is (703) 305-5805. Please review the visitor instructions and
additional information about the docket available at http://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: 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:
[[Page 87457]]
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
B. How can I get electronic access to other related information?
You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.
C. How can I file an objection or hearing request?
Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2015-0439 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
February 3, 2017. Addresses for mail and hand delivery of objections
and hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2015-0439, by one of
the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave., NW., Washington, DC
20460-0001.
Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.
II. Summary of Petitioned-For Tolerance
In the Federal Register of August 26, 2015 (80 FR 51759) (FRL-9931-
74), 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
5E8362) by Makhteshim Agan of North America, Inc., d/b/a ADAMA, 3120
Highwoods Blvd., Suite 100, Raleigh, NC 27604. The petition requested
that 40 CFR 180.427 be amended by establishing a tolerance for residues
of the insecticide/miticide tau-fluvalinate in or on wine grapes at 1.0
parts per million (ppm). That document referenced a summary of the
petition prepared by Makhteshim Agan of North America, Inc., d/b/a
ADAMA, the registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the
notice of filing.
III. Aggregate Risk Assessment and Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
.''
Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for tau-fluvalinate including
exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with tau-fluvalinate
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.
Tau-fluvalinate is a member of the pyrethroid class of
insecticides. Pyrethroids have historically been classified into two
groups, Type I and Type II, based on chemical structure and
toxicological effects. Tau-fluvalinate is a Type II pyrethroid.
Neurotoxicity was observed throughout the database and clinical signs
characteristic of Type II pyrethroids, such as excessive salivation,
tremors, pawing, abnormal stance, excessive lacrimation, bulging eyes,
ruffling, excessive grooming, vocalization and hyperactivity followed
by hypoactivity were seen. Other observed neurotoxic effects included
decreased rearing, forelimb grip strength and body temperature,
heightened sensitivity to pain, and impaired motor, autonomic, and
sensorimotor function.
No increased prenatal susceptibility was observed following
developmental toxicity studies in the rat or rabbit. Tau-fluvalinate
did not have an effect on fetal development in the prenatal
developmental study in rats. In the prenatal developmental study in
rabbits, maternal and fetal effects were seen at the highest dose
tested. Developmental effects included skeletal anomalies, a lower
implantation efficiency, higher incidence of resorption and concurrent
lower fetal viability. Maternal effects involved anorexia and general
depression. The qualitative susceptibility seen during the prenatal
developmental study in rabbits is secondary to maternal toxicity and
occurs at the same dose. Evidence of quantitative post-natal
sensitivity was
[[Page 87458]]
observed in the 2-generation reproduction study in rats. Under the
conditions of this study, both the F1 and F2
litters experienced tremors during lactation and decreased pup and
litter weight in both litters while no effects were noted in the adult
animals. However, when considered in the context of the totality of the
database, a different pattern emerges regarding this apparent lifestage
sensitivity. It appears that the postnatal sensitivity seen in the
reproduction study reflects the limited evaluation of adult animals as
well as the potential for greater pup exposure through both milk and
feed rather than a specific lifestage sensitivity. There are on-going
efforts to develop methods to investigate the possibility of increased
sensitivity of juvenile rats to pyrethroids as a class at doses near
the lowest observed adverse effect level (LOAEL) values. Pending
receipt of the additional data, the Agency has conducted an assessment
using the available guideline and literature studies. This approach is
consistent with assessments performed for other pyrethroid pesticides.
A dermal assessment was not conducted based on the lack of systemic
toxicity in the rabbit dermal study at the limit dose and the low
potential for dermal absorption. These findings are consistent with the
toxicology profile of many pyrethroids. In an acute inhalation
neurotoxicity study, neurotoxic effects were observed in the functional
observational battery (FOB) including decreased rearing, forelimb grip
strength and body temperature in females. This route-specific study
provides a robust endpoint for the inhalation route of exposure and was
used to estimate human inhalation risks. The standard interspecies
extrapolation uncertainty factor is reduced from 10X to 3X due to the
human equivalent concentration (HEC) calculation accounting for
pharmacokinetic (not pharmacodynamic) interspecies differences.
However, due to the lack of a clear no- observed-adverse-effect-level
(NOAEL) in the acute inhalation neurotoxicity study, an additional 10X
is added to extrapolate a NOAEL from a lowest-observed-adverse-effect-
level (LOAEL). The 10X intraspecies factor is also applied. The total
uncertainty factor for inhalation exposure is 300X for adults and
children >6 years of age. The total inhalation uncertainty factor for
children <=6 years of age is 1,000X since the Food Quality Protection
Act safety factor (FQPA SF) of 3X applies.
There was no evidence of carcinogenicity in the combined chronic
gavage/carcinogenicity study in rats or the carcinogenicity study in
mice. In a battery of mutagenicity studies, there was no evidence of a
mutagenic effect.
Specific information on the studies received and the nature of the
adverse effects caused by tau-fluvalinate as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in the document titled ``Tau-fluvalinate. Human
Health Risk Assessment for Registration Review and for Establishment of
a Tolerance with No U.S. Registrations for Residues in Wine Grapes'' on
page 52 in docket ID number EPA-HQ-OPP-2015-0439.
B. Toxicological Points of Departure/Levels of Concern
Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
The database of tau-fluvalinate toxicology studies is complete and
provides a robust characterization of the hazard potential for children
and adults. In addition to the standard guideline studies, numerous
studies from the scientific literature that describe the
pharmacodynamic (PD) and pharmacokinetic (PK) profile of the
pyrethroids in general have been considered in EPA's assessment. Tau-
fluvalinate is rapidly absorbed following an oral dose, and effects are
typically observed within the first several hours after dosing. For
pyrethroids, as a class, the combination of rapid absorption,
metabolism, and elimination precludes accumulation and increased
potency following repeated dosing. This is also true of tau-
fluvalinate. However, the combined chronic gavage/carcinogenicity
neurotoxicity study is more appropriate for point of departure (POD)
selection than the acute oral studies, because it is more sensitive.
This is likely due to the lower doses tested, and the lower gavage
volume used to administer tau-fluvalinate. While acute neurotoxic
effects are the most sensitive effects observed in the toxicity
database, neurotoxic effects attributable to chronic exposure to tau-
fluvalinate have not been identified. The clinical signs in the
combined chronic gavage/carcinogenicity neurotoxicity study disappeared
each day prior to the next dosing and did not progress in severity
across time. This POD is the most protective within the database and
will be protective of the acute neurotoxic effects seen in the acute,
subchronic and 2-generation reproduction studies in the rat. All
exposure durations for the tau-fluvalinate risk assessment are assessed
as single-day exposures.
A summary of the toxicological endpoints for tau-fluvalinate used
for human risk assessment is shown in Table 1 of this unit.
[[Page 87459]]
Table 1--Summary of Toxicological Doses and Endpoints for Tau-fluvalinate for Use in Human Health Risk
Assessment
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Point of departure
Exposure/scenario and uncertainty/ RfD, PAD, LOC for Study and toxicological effects
safety factors risk assessment
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Acute dietary (Children < 6 years NOAEL = 1.0 mg/kg/ Acute RfD = 0.01 mg/ Combined chronic gavage/
old). day. kg/day. carcinogenicity study.
UFA = 10x........... aPAD = 0.003 mg/kg/ LOAEL = 2.5 mg/kg/day. Clinical
UFH = 10x........... day. signs of neurotoxicity including
FQPA SF = 3x........ excessive salivation, pawing,
abnormal stance, excessive
lacrimation, ruffling and
hyperactivity followed by
hypoactivity.
Acute dietary (Adults and NOAEL = 1.0 mg/kg/ Acute RfD = 0.01 mg/ Combined chronic gavage/
children >= 6 years old). day. kg/day. carcinogenicity study.
UFA = 10x........... aPAD = 0.01 mg/kg/ LOAEL = 2.5 mg/kg/day. Clinical
UFH = 10x........... day. signs of neurotoxicity including
FQPA SF = 1x........ excessive salivation, pawing,
abnormal stance, excessive
lacrimation, ruffling and
hyperactivity followed by
hypoactivity.
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Chronic dietary (All populations) Neurotoxic effects, the most sensitive effects observed in the toxicity
database, attributable to chronic exposure to tau-fluvalinate have not been
identified (neurotoxic effects do not progress over time).
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Inhalation short-term (1 to 30 Inhalation study LOC for MOE = 1,000 Acute inhalation study.
days). LOAEC= 20 mg/m\3\. (Children <6 years LOAEL = 20 mg/m \3\ (LDT).
UFA = 3x............ old). Increased glucose levels and
UFH = 10x........... LOC for MOE = 300 decreased body temperature,
UFL = 10x........... (Adults and rearing and forelimb grip
FQPA SF= 3x children >=6 years strength in females in addition
(Children <6 years old). to soiled fur appearance.
old).
FQPA SF= 1x (Adults
and children >=6
years old).
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Cancer (Oral, dermal, inhalation) Tau-fluvalinate has been classified as not likely to be a human carcinogen.
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FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor.
UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among
members of the human population (intraspecies). UFL = use of a LOAEL to extrapolate a NOAEL.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to tau-fluvalinate, EPA considered exposure under the
petitioned-for tolerances as well as all existing tau-fluvalinate
tolerances in 40 CFR 180.427. EPA assessed dietary exposures from tau-
fluvalinate 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 tau-fluvalinate. In estimating
acute dietary exposure, EPA used food consumption information from the
United States Department of Agriculture's (USDA) 2003-2008 National
Health and Nutrition Survey/What We Eat in America (NHANES/WWEIA). As
to residue levels in food, EPA assumed tolerance-level residues and 100
percent crop treated (PCT) for all registered and proposed commodities.
ii. Chronic exposure. Neurotoxic effects, the most sensitive
effects observed in the toxicity database, attributable to chronic
exposure to tau-fluvalinate have not been identified (neurotoxic
effects do not progress over time); therefore, a quantitative chronic
aggregate risk assessment was not conducted.
iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that tau-fluvalinate does not pose a cancer hazard to humans.
Therefore, a dietary exposure assessment for the purpose of assessing
cancer risk is unnecessary.
iv. Anticipated residue and PCT information. EPA did not use
anticipated residue or PCT information in the dietary assessment for
tau-fluvalinate. Tolerance level residues and 100 PCT were assumed for
all food commodities.
2. Dietary exposure from drinking water. As a class of chemicals,
the pyrethroids have low water solubility and a high affinity to bind
to soils. Given these physical/chemical properties, it is unlikely that
dietary exposure from drinking water will be a major pathway of
exposure. The existing beehive use and use on wine grapes grown outside
of the U.S. will not result in tau-fluvalinate entering drinking water
sources. However, the outdoor, non-food uses (including carrots and
Brassica/cole crops grown for seed, ornamentals and building
perimeters) could potentially result in residues in surface or ground
water. The limit of water solubility, 2.4 ppb, is used for tau-
fluvalinate as an upper-bound estimated drinking water concentration
(EDWC) for this assessment.
3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets). Tau-fluvalinate is
currently registered for the following uses that could result in
residential exposures: Outdoor residential settings including outside
surfaces (crack and crevice), ant mound treatments (spot application)
and use on roses, flowers, houseplants, ground covers, vines,
ornamentals, shrubs and trees. EPA assessed residential exposure
[[Page 87460]]
using the following assumptions: Because a dermal hazard was not
identified for tau-fluvalinate, only inhalation exposures were assessed
for handlers. The quantitative exposure/risk assessment developed for
residential handlers is based on the following scenarios: (1) Applying
ready-to-use (RTU) spray for use on gardens/trees, flowers, and
ornamentals; (2) Mixing/loading/applying liquids with pump sprayer/
hose-end sprayer for use on gardens/trees, flowers, and ornamentals;
(3) Mixing/loading/applying liquids with manually pressurized handwand
for use on gardens/trees, flowers, and ornamentals; (4) Mixing/loading/
applying liquids with backpack for use on gardens/trees, flowers, and
ornamentals; (5) Mixing/loading/applying liquids with a sprinkler can
for use on gardens/trees, flowers, and ornamentals; and (6) Applying
RTU spray to spot or crack and crevice treatment outdoors.
Although there is potential for post-application exposure to
individuals as a result of being in an environment that has been
previously treated with tau-fluvalinate, post-application inhalation
exposure is anticipated to be negligible due to the combination of low
vapor pressure for tau-fluvalinate and the expected dilution in outdoor
air. In addition, because no dermal POD was selected for tau-
fluvalinate (i.e., there is no dermal hazard), a quantitative
residential dermal post-application exposure assessment was not
performed.
Post-application non-dietary ingestion exposure was also not
quantitatively assessed for young children. Unlike treated grass at
home or in recreational areas or indoor floor surfaces, for the tau-
fluvalinate registered outdoor uses (e.g., flowers, trees, crack and
crevice), the potential for exposure via non-dietary ingestion for
young children is greatly diminished. Since the extent to which young
children engage in the types of activities associated with these areas
(e.g., gardening) or utilize these areas for prolonged periods of play
is low, significant non-dietary ingestion exposure is not expected.
Further information regarding EPA standard assumptions and generic
inputs for residential exposures may be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide.
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.''
The Agency has determined that the pyrethroids and pyrethrins share
a common mechanism of toxicity http://www.regulations.gov; EPA-HQ-OPP-
2008-0489-0006. The members of this group share the ability to interact
with voltage-gated sodium channels ultimately leading to neurotoxicity.
The cumulative risk assessment (CRA) for the pyrethroids/pyrethrins was
published on November 9, 2011 and is available at http://www.regulations.gov; EPA-HQ-OPP-2011-0746. No cumulative risks of
concern were identified, allowing the agency to consider new uses for
pyrethroids. For information regarding EPA's efforts to evaluate the
risk of exposure to this class of chemicals, refer to http://www.epa.gov/oppsrrd1/reevaluation/pyrethroids-pyrethrins.html.
Tau-fluvalinate was included in the 2011 pyrethroid CRA. In the
cumulative assessment, residential exposure was the greatest
contributor to the total exposure. There are currently registered tau-
fluvalinate products for outdoor residential uses that have not been
previously assessed and were not included in the CRA. In order to
determine if the currently registered tau-fluvalinate residential uses
will significantly contribute to or change the overall findings in the
pyrethroid CRA, the Agency performed a quantitative cumulative
screening assessment. This assessment used the currently registered
application rates for tau-fluvalinate along with the previous
assumptions as used in the 2011 CRA (i.e., unit exposures, body weight,
and the relative potency factor (RPF) for tau-fluvalinate). The
resulting exposures were then compared to the pyrethroid CRA index
point of departure (index POD) to calculate the screening MOEs. These
screening MOEs were then be directly compared to the MOEs that were
calculated in the CRA. If the screening MOEs are similar to, or are
greater than, the CRA MOEs, then it can be concluded that any currently
registered residential uses will not have an impact on the pyrethroid
CRA.
The outdoor garden uses resulting in the highest residential
exposures for tau-fluvalinate are selected for the screening assessment
(specifically, the backpack sprayer and RTU hose-end sprayer garden
scenarios). As there is no post-application inhalation or child
incidental oral exposures expected from the garden uses, and there is
no dermal hazard for tau-fluvalinate, it is only necessary to perform
an adult handler inhalation assessment.
The resulting screening MOEs (adult handler) for tau-fluvalinate
garden backpack and hose end sprayer scenarios are 1,300,000 and
61,000, respectively. In the CRA, the garden risk driver was identified
as the tau-fluvalinate backpack use and the MOE for that scenario was
1,300. However, since the 2011 CRA, it has been determined that there
is no dermal hazard for tau-fluvalinate. With the dermal exposures
removed, that MOE would now be 780,000 and would no longer be
considered the highest risk driver. Therefore, the next highest risk
driver for the CRA garden scenario is used which is the cypermethrin
backpack use with a total MOE of 1,400. Since the screening MOEs
(1,300,000 and 260,000) are much greater than the CRA MOE (1,400), it
can be concluded that the currently registered tau-fluvalinate
residential uses will not significantly impact the overall findings in
the 2011 pyrethroid CRA.
Dietary exposures make a minor contribution to the total pyrethroid
exposure. The dietary exposure assessment performed in support of the
pyrethroid cumulative was much more highly refined than that performed
for the single chemical. The proposed tolerance for residues of tau-
fluvalinate on imported wine grape will make an insignificant
contribution to dietary risk to the pyrethroids as a whole.
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. After reviewing the
extensive body of peer-reviewed literature on pyrethroids, the Agency
has no residual uncertainties regarding age-related sensitivity for
women of child bearing age as well as for all adult populations and
children >6 years of age, based on the absence of pre-natal sensitivity
observed in 76 guideline studies for 24
[[Page 87461]]
pyrethroids and the scientific literature. Additionally, no evidence of
increased quantitative or qualitative susceptibility was seen in the
pyrethroid scientific literature related to PD. The Agency is retaining
a 3X FQPA Safety Factor to protect for exposures of children <=6 years
of age based on the increased quantitative susceptibility seen in
studies on pyrethroid PKs and the increased quantitative juvenile
susceptibility observed in high dose studies in the literature.
Although sensitivity was observed in the 2-generation reproduction
study, there is a clear NOAEL for the effects (tremors), and the PODs
selected for risk assessment are 10-fold lower than where sensitivity
was observed, and are therefore protective. When considered within the
context of the totality of the database, EPA believes that the apparent
sensitivity in the multi-generation reproduction toxicity study in rats
is a reflection of the study's design rather than a lifestage
sensitivity per se. In addition, the LOAELs from the maternal rat
prenatal developmental study and the offspring 2-generation
reproduction study are ~10 mg/kg/day. There is no sensitivity observed
across the rat prenatal developmental and 2-generation reproduction
studies.
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 for adults and the general population and 3X
to protect for exposures of children <=6 years of age based on the
increased quantitative susceptibility seen in studies on pyrethroid PKs
and the increased quantitative juvenile susceptibility observed in high
dose studies in the literature. That decision is based on the following
findings:
i. The toxicology database is adequate for the evaluation of risks
to infants and children. Acceptable studies include: Rat and rabbit
developmental toxicity studies, a rat multi-generation reproduction
study and chronic toxicity/carcinogenicity studies in mice and rats. In
addition, acceptable acute (non-guideline) and subchronic (guideline)
neurotoxicity studies in the rat are adequate to evaluate the
neurotoxicity of tau-fluvalinate.
EPA is making best use of the extensive scientific knowledge about
the adverse outcome pathway of pyrethroids in the risk assessments for
this class of pesticides. In this way, information on a subset of
pyrethroids can be used to help interpret and understand the
toxicological profile for other members of the class. In that regard, a
group of pesticide registrants and product formulators known as the
Council for the Advancement of Pyrethroid Human Risk Assessment
(CAPHRA) has been conducting multiple experiments with permethrin and
deltamethrin as model Type I and Type II compounds, respectively, in
order to develop an initial extensive database of in vitro and in vivo
toxicology studies and highly refined physiologically-based
pharmacokinetic (PBPK) models. In light of the literature studies
indicating a possibility of increased sensitivity in juvenile rats at
high doses, the agency is expecting additional in vitro and in vivo
data to help elucidate the biological processes underlying the juvenile
sensitivity reported in the peer reviewed literature. In 2010, the
agency requested proposals for study protocols that could identify and
quantify potential juvenile sensitivity and received a single response
from the Pyrethrin and Pyrethroids Technical Working Group (PPTWG), a
conglomerate of pyrethroid registrants. The PPTWG protocol has been
reviewed, the initial study proposal was refined, and the CAPHRA
submitted its updated research. Currently, the CAPHRA is continuing to:
(1) Develop rat and human PBPK models, including additional PK data,
and (2) conduct in vivo behavioral testing using auditory startle
testing in rats and plans to submit additional data to the agency. For
the reasons discussed in Unit III.D.2., the uncertainty regarding the
protectiveness of the intraspecies uncertainty factor raised by the
literature studies and the absence of the requested data warrant
application of an additional 3X for risk assessments for infants and
children under 6 years of age.
ii. As with other pyrethroids, tau-fluvalinate causes neurotoxicity
from interaction with sodium channels leading to clinical signs of
neurotoxicity. Neurotoxicity was observed in several of the toxicity
studies for the active ingredient; however, concern is low, because the
selected endpoints are protective of the observed effects. The effects
are well characterized and adequately assessed by the available
guideline and non-guideline studies.
iii. There were no indications of fetal toxicity in the rat
developmental toxicity study. In the rabbit developmental toxicity
study, there were fetotoxic effects, as indicated by a lower
implantation efficiency, higher incidence of resorption and concurrent
lower fetal viability in the high-dose group. However, effects were
likely secondary to maternal toxicity at the same dose (125 mg/kg/day).
There were signs of post-natal sensitivity in the tau-fluvalinate 2-
generation reproduction study in rats. The parental generation did not
experience any systemic effects up to the highest dose tested, where
there were tremors during lactation in both F1 and
F2 litters, as well as decreased pup body and litter weights
in both generations. The degree of concern for these effects in infants
is low, because the offspring effects have clearly defined NOAELs/
LOAELs and the POD selected for risk assessment is protective of these
effects.
iv. There are no residual uncertainties in the exposure database.
Dietary exposures to tau-fluvalinate are estimated using tolerance
level residues and 100 PCT. The high-end EDWC for tau-fluvalinate is
based on the limit of solubility in water. Adequate exposure data are
available to assess the residential exposures. These assessments will
not underestimate the exposure and risks posed by tau-fluvalinate.
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. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to tau-fluvalinate will occupy 20% of the aPAD for adults 50 to 99
years old, the population group receiving the greatest exposure.
2. Chronic risk. Based on the data summarized in Unit III.A., there
is no increase in hazard with increasing dosing duration. Furthermore,
chronic dietary exposures will be lower than acute exposures.
Therefore, the acute aggregate assessment is protective of potential
chronic aggregate exposures.
3. Short-term risk. Tau-fluvalinate is currently registered for
uses that could result in short-term residential exposure, and the
Agency has determined that it is appropriate to aggregate chronic
exposure through food and water with short-term residential exposures
to tau-fluvalinate.
An Aggregate Risk Index (ARI) approach was used to aggregate the
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dietary and residential (inhalation) exposures since the levels of
concern are not the same for those exposures (100 and 300,
respectively). Using the exposure assumptions described in this unit
for short-term exposures, EPA has concluded the combined short-term
food, water, and residential exposures result in an aggregate ARI of 74
for adults. Because EPA's level of concern for tau-fluvalinate is an
ARI of 1 or below, this ARI is not of concern.
4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level).
Because no intermediate-term adverse effect was identified, tau-
fluvalinate is not expected to pose an intermediate-term risk.
5. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, tau-fluvalinate is not expected to pose a cancer risk to
humans.
6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to tau-fluvalinate residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Acceptable methods are available for enforcement and data
collection purposes for both plant and animal commodities. The
Pesticide Analytical Manual (PAM) Volume II lists Method I, a GC method
with electron capture detection (ECD), for the enforcement of
tolerances for fluvalinate in/on plant and animal commodities.
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 tau-fluvalinate.
C. Revisions to Petitioned-For Tolerances
Finally, EPA has revised the tolerance expression to clarify (1)
that, as provided in FFDCA section 408(a)(3), the tolerance covers
metabolites and degradates of tau-fluvalinate not specifically
mentioned; and (2) that compliance with the specified tolerance levels
is to be determined by measuring only the specific compounds mentioned
in the tolerance expression.
V. Conclusion
Therefore, a tolerance is established for residues of tau-
fluvalinate, in or on grape, wine at 1.0 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) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997). This action does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This action directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(UMRA) (2 U.S.C. 1501 et seq.).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).
VII. Congressional Review Act
Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: November 10, 2016.
Michael Goodis,
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. In Sec. 180.427:
0
a. Revise the introductory text in paragraph (a); and
[[Page 87463]]
0
b. Add alphabetically the entry ``Grape, wine'' and footnote 1 to the
table in paragraph (a).
The additions and revisions read as follows:
Sec. 180.427 Tau-Fluvalinate; tolerances for residues.
(a) General. Tolerances are established for residues of the
insecticide tau-fluvalinate, including its metabolites and degradates,
in or on commodities in the table below. Compliance with the specified
tolerance level is to be determined by measuring only tau-fluvalinate,
(cyano-(3-phenoxyphenyl)methylN-[2-chloro-4-(trifluoromethyl)phenyl]-D-
valinate), in or on the commodity.
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Grape, wine \1\........................................... 1.0
* * * * *
------------------------------------------------------------------------
\1\ There is no U.S. registration for use of tau-fluvalinate on wine
grapes.
* * * * *
[FR Doc. 2016-29111 Filed 12-2-16; 8:45 am]
BILLING CODE 6560-50-P