[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]



40 CFR Part 180

[EPA-HQ-OPP-2015-0439; FRL-9954-33]

Tau-Fluvalinate; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.


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].


[[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 
     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 

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 
    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
                                    Point of departure
        Exposure/scenario            and uncertainty/     RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk assessment
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
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
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).
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.
                                   FQPA SF= 1x (Adults
                                    and children >=6
                                    years old).
Cancer (Oral, dermal, inhalation)  Tau-fluvalinate has been classified as not likely to be a human carcinogen.
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 
    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 
    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 
    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 
    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 
    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 
    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 
    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 
    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:


1. The authority citation for part 180 continues to read as follows:

    Authority:  21 U.S.C. 321(q), 346a and 371.

2. In Sec.  180.427:
a. Revise the introductory text in paragraph (a); and

[[Page 87463]]

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, 
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

* * * * *
[FR Doc. 2016-29111 Filed 12-2-16; 8:45 am]