Tolfenpyrad; Pesticide Tolerances, 1599-1606 [2014-00163]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 79, Number 6 (Thursday, January 9, 2014)]
[Rules and Regulations]
[Pages 1599-1606]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-00163]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2012-0909; FRL-9904-70]


Tolfenpyrad; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
tolfenpyrad in or on multiple commodities which are identified and 
discussed later in this document. Nichino America, Inc. requested these 
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective January 9, 2014. Objections and 
requests for hearings must be received on or before March 10, 2014, 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-2012-0909, 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), EPA West 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: Lois Rossi, Registration Division, 
Office of Pesticide Programs, Environmental Protection Agency, 1200 
Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: 
(703) 305-0001; 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/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl. To access the OCSPP 
test guidelines referenced in this document electronically, please go 
to https://www.epa.gov/ocspp and select ``Test Methods and Guidelines.''

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-2012-0909 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 10, 2014. 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-2012-0909, 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

[[Page 1600]]

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.htm.
    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 May 02, 2012 (77 FR 25954) (FRL-9346-1), 
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 0F7791) 
by Nichino America, Inc., 4550 New Linden Hill Rd., Suite 501, 
Wilmington, DE 19808. The petition requested that 40 CFR 180 be amended 
by establishing tolerances for residues of the insecticide tolfenpyrad 
(4-chloro-3-ethyl-1-methyl-N-[4-(p-tolyloxy) benzyl] pyrazole-5-
carboxamide, in or on head lettuce at 5 ppm; leaf lettuce at 30 ppm; 
leaf petioles, subgroup 4B at 12.5 ppm; spinach at 24 ppm; Brassica, 
head and stem, subgroup 5A at 3.6 ppm; Brassica, leafy, subgroup 5B at 
44 ppm; vegetable, fruiting group 8 at 0.6 ppm; potatoes at 0.04 ppm; 
nut, tree group 14 (including pistachio) at 0.04 ppm; almond, hulls at 
5.0 ppm; fruit, pome, group 11 at 0.6 ppm; apple, wet pomace at 5.0 
ppm; vegetable, cucurbit, group 9 at 0.8 ppm; fruit, stone, group 12 at 
3.0 ppm; pomegranates at 3.0 ppm; persimmons at 3.0 ppm; citrus, group 
10 at 1.0 ppm; citrus, pulp, dried at 2.0 ppm; citrus, oil at 16.0 ppm; 
grapes at 2.0 ppm; raisins at 5 ppm; cotton, undelinted seed at 0.6 
ppm; cotton, gin byproducts at 9.0 ppm; tea at 20 ppm; milk at 0.03 
ppm; cattle, fat, at 0.01 ppm; goat, fat at 0.01 ppm; horse, fat at 
0.01 ppm; sheep, fat at 0.01 ppm; cattle, kidney at 0.3 ppm; goat, 
kidney at 0.3 ppm; horse, kidney at 0.3 ppm; sheep, kidney at 0.3 ppm; 
cattle, liver at 0.7 ppm; goat, liver at 0.7 ppm; horse, liver at 0.7 
ppm; sheep, liver at 0.7 ppm; cattle, meat at 0.02 ppm; goat, meat at 
0.02 ppm; horse, meat at 0.02 ppm, and sheep, meat at 0.02 ppm. That 
document referenced a summary of the petition prepared by Nichino 
America, Inc., the registrant, which is available in the docket, https://www.regulations.gov. There were no comments received in response to 
the notice of filing.
    Based upon review of the data supporting the petition, EPA has 
revised nearly all of the proposed tolerances. The reasons for these 
changes are explained in Unit IV.D.

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 tolfenpyrad including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with tolfenpyrad 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. Tolfenpyrad is a broad-spectrum pyrazole insecticide that is 
proposed for use to control thrips, aphids and scales through the egg, 
larval, nymph, and adult stages. The toxicity database for tolfenpyrad 
is complete. Tolfenpyrad is acutely toxic by oral route, but has low 
acute inhalation and dermal toxicity. It is also not irritating to the 
eye and skin and is not a skin sensitizer.
    Toxicological testing indicates that tolfenpyrad is not neurotoxic 
or immunotoxic and it is classified as ``not likely to be carcinogenic 
to humans.'' However, the most consistent finding across species and 
studies was effects on body weight and body weight gain. Decreases in 
body weight and/or body weight gain were observed in adults of all 
species (rat, mice, rabbit, and dog) in the majority of the subchronic 
oral and dermal toxicity studies, and all chronic toxicity studies.
    The rat is the species most sensitive to body weight changes, with 
effects observed at much lower doses than in other species. In rats, 
significant decreases in body weight and body weight gain were observed 
in subchronic oral and acute and subchronic neurotoxicity studies. 
Decreases in body weight and body weight gain were also seen in chronic 
rat studies but at lower doses than observed in the other rat studies. 
Although seen at lower doses, the body weight decrements noted in the 
chronic study were not as pronounced as seen after subchronic exposure 
or in the neurotoxicity studies. Decreases in body weight and body 
weight gain were also observed in reproduction, developmental toxicity, 
and developmental immunotoxicity studies at doses comparable to the 
chronic study. Body weight changes observed in other species were 
similar in magnitude to those in rats, but were observed at higher 
doses. Significant decreases in body weight and body weight gain were 
seen in both mice and dogs after subchronic exposure; these effects 
were also noted in rabbits in a developmental toxicity study. Chronic 
exposure resulted in body weight and body weight gain decreases in mice 
and dogs at lower doses. The severity of body weight changes increased 
with dose in mice while body weight effects in dogs were seen only at 
the highest dose tested.
    The body weight changes observed in the database were most often 
seen in the presence of decreased food consumption and in some studies, 
additional toxicity including liver/kidney effects and clinical signs. 
Increased liver and kidney weights, liver and kidney hypertrophy, 
hyaline droplets in the kidney, and color change in the kidney were 
seen after subchronic exposure in rats. Chronic exposure resulted in 
similar effects along with color changes in the liver and liver 
histopathology at slightly lower doses than in the subchronic studies. 
Other effects noted in rats were effects on the

[[Page 1601]]

harderian gland and lymph nodes. In dogs, both liver and kidney 
histopathology, along with testicular atrophy and clinical signs 
(emaciation, decreased movement, and staggering gait) were seen in 
short-term studies. Long-term exposure resulted in histopathology in 
the liver only, along with increased liver enzymes. No treatment-
related effects were noted in the liver or kidney in mice. However, 
rough coats, hunched posture, ataxia, and hypoactivity were seen in 
subchronic studies. Missing ears and ear lesions (scabs, sores, 
ulceration, and inflammation) were seen in a chronic toxicity study. 
The ear lesions observed were likely self inflicted since the mice in 
the study were individually caged. No explanation was given to why the 
lesions occurred and the toxicological significance of this finding is 
unclear.
    Moribundity and/or mortality were noted in at least one study in 
all species at >= 3 milligrams/kilogram/day (mg/kg/day). Moribundity 
and mortality were noted in two dams in a rat reproduction study, and 
mortality was noted in one dam in a rabbit developmental toxicity 
study. Mortality was also observed in two animals in an inhalation 
toxicity study (range-finding only). In mice and dogs, mortality was 
observed in both subchronic and chronic toxicity studies. In all cases, 
effects were observed in the presence of body weight changes and the 
points of departure (POD) are protective of the observed mortality.
    There is no evidence of increased quantitative or qualitative 
susceptibility in the guideline rat and rabbit developmental studies, 
or the rat reproduction study. Although several adverse effects were 
noted in young animals in these studies, the effects were observed in 
the presence of significant maternal toxicity (significant body weight 
changes and/or moribundity/mortality). In a non-guideline rat 
developmental immunotoxicity (DIT) study, a potential increase in 
qualitative susceptibility was seen. In the study, decreased survival, 
body weight, body weight gain, increased blackish abdominal cavity, and 
dark green abnormal intestinal contents were observed in offspring 
animals at 3 mg/kg/day. At the same dose, decreased body weight (up to 
10%), body weight gain (up to 36%) and food consumption were seen in 
maternal animals. There was no evidence of immunotoxicity observed in 
the study.
    No evidence of neurotoxicity was observed in acute and subchronic 
neurotoxicity studies for tolfenpyrad. Although hunched posture, 
ataxia, and hypoactivity were seen in mice in a 28-day toxicity study, 
these effects were not seen in a 90-day study or after chronic 
exposure. In dogs, decreased spontaneous movement, and staggering gait 
were observed after 13 weeks. In rats, decreased motor activity and 
prone position (lying face down) prior to death were noted in a 
reproduction study. Overall, the effects noted in the database were 
agonal effects mainly seen at high doses, not associated with 
neuropathology, and not noted in long-term studies. The effects 
observed are consistent with the mode of action for tolfenpyrad 
(mitochondrial inhibitor) and are not considered evidence of 
neurotoxicity.
    No evidence of carcinogenicity was observed in cancer studies with 
mice and rats. Therefore, in accordance with EPA's Final Guidelines for 
Carcinogen Risk Assessment (March 2005), tolfenpyrad is classified as 
``not likely to be carcinogenic to humans.'' Specific information on 
the studies received and the nature of the adverse effects caused by 
tolfenpyrad 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 document 
``Tolfenpyrad. Human Health Risk Assessment'' in docket ID number EPA-
HQ-OPP-2012-0909.

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 tolfenpyrad used for human risk assessment is shown in 
Table 1 of this unit.

   Table 1--Summary of Toxicological Doses and Endpoints for Tolfenpyrad For Use In Dietary Human Health Risk
                                                   Assessments
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                                                                 RfD, PAD, level
                                   Point of       Uncertainty/   of  concern for      Study and toxicological
      Exposure/scenario           departure       FQPA safety          risk                   effects
                                                    factors         assessment
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Acute Dietary (General         NOAEL = 10 mg/   UFA = 10 x.....  Acute RfD = 0.1  LOAEL = 20 mg/kg/day from an
 Population, including          kg/day.         UFH = 10 x.....   mg/kg/day.       acute neurotoxicity study in
 Infants and Children).                         FQPA...........  aPAD = 0.1 mg/    rats, based on decreased body
                                                SF = 1x........   kg/day.          weight, body weight gain and
                                                                                   food consumption
Chronic Dietary (All           NOAEL = 0.6 mg/  UFA = 10 x.....  Chronic RfD =    LOAEL = 1.5 mg/kg/day from a
 Populations).                  kg/day.         UFH = 10 x.....   0.006 mg/kg/     combined chronic/
                                                FQPA SF = 1x...   day.             carcinogenicity in rats,
                                                                 cPAD = 0.006 mg/  based on decreased body
                                                                  kg/day.          weight, body weight gain, and
                                                                                   food consumption of females,
                                                                                   gross changes in the
                                                                                   Harderian glands of males,
                                                                                   and histopathological changes
                                                                                   in the liver, kidney, and
                                                                                   mesenteric lymph nodes of
                                                                                   females and the kidney of
                                                                                   males

[[Page 1602]]

 
Cancer.......................   Classification: ``Not likely to be Carcinogenic to Humans'' based on the absence
                                 of significant tumor increases in two adequate rodent carcinogenicity studies.
----------------------------------------------------------------------------------------------------------------
Point of Departure (POD) = A data point or an estimated point that is derived from observed dose-response data
  and used to mark the beginning of extrapolation to determine risk associated with lower environmentally
  relevant human exposures. NOAEL = no observed adverse effect level. LOAEL = lowest observed adverse effect
  level. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential
  variation in sensitivity among members of the human population (intraspecies). FQPA SF = FQPA Safety Factor.
  PAD = population-adjusted dose (a = acute, c = chronic). RfD = reference dose.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to tolfenpyrad, EPA considered exposure under the petitioned-
for tolerances. EPA assessed dietary exposures from tolfenpyrad 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 tolfenpyrad. In estimating acute dietary exposure, EPA used food 
consumption information from the U.S. Department of Agriculture (USDA) 
2003-2008 National Health and Nutrition Examination Survey, What We Eat 
in America (NHANES/WWEIA). As to residue levels in food, EPA assumed 
100 percent crop treated (PCT) and tolerance-level residues.
    ii. Chronic exposure. The chronic assessment is significantly 
refined. Inputs to the chronic assessment include average residue 
levels from crop field trials; use of projected PCT estimates for foods 
that were shown to have a high contribution to the overall dietary 
exposure (as discussed in Unit III.C.1.iv.) and assumptions of 100 PCT 
for the rest of the commodities; liberal translation of juice 
processing factors; and reduction of residues from removal of head 
lettuce and cabbage wrapper leaves.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that there was no evidence of carcinogenicity in cancer 
studies with mice and rats. Therefore, a cancer exposure assessment was 
not conducted.
    iv. Anticipated residue and PCT information. Section 408(b)(2)(E) 
of FFDCA authorizes EPA to use available data and information on the 
anticipated residue levels of pesticide residues in food and the actual 
levels of pesticide residues that have been measured in food. If EPA 
relies on such information, EPA must require pursuant to FFDCA section 
408(f)(1) that data be provided 5 years after the tolerance is 
established, modified, or left in effect, demonstrating that the levels 
in food are not above the levels anticipated. For the present action, 
EPA will issue such Data Call-Ins as are required by FFDCA section 
408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Data will be 
required to be submitted no later than 5 years from the date of 
issuance of these tolerances.
    Section 408(b)(2)(F) of FFDCA states that the Agency may use data 
on the actual percent of food treated for assessing chronic dietary 
risk only if:
     Condition a: The data used are reliable and provide a 
valid basis to show what percentage of the food derived from such crop 
is likely to contain the pesticide residue.
     Condition b: The exposure estimate does not underestimate 
exposure for any significant subpopulation group.
     Condition c: Data are available on pesticide use and food 
consumption in a particular area, the exposure estimate does not 
understate exposure for the population in such area.

In addition, the Agency must provide for periodic evaluation of any 
estimates used. To provide for the periodic evaluation of the estimate 
of PCT as required by FFDCA section 408(b)(2)(F), EPA may require 
registrants to submit data on PCT.
    In most cases, EPA uses available data from United States 
Department of Agriculture/National Agricultural Statistics Service 
(USDA/NASS), proprietary market surveys, and the National Pesticide Use 
Database for the chemical/crop combination for the most recent 6-7 
years. EPA uses an average PCT for chronic dietary risk analysis. The 
average PCT figure for each existing use is derived by combining 
available public and private market survey data for that use, averaging 
across all observations, and rounding to the nearest 5%, except for 
those situations in which the average PCT is less than one. In those 
cases, 1% is used as the average PCT and 2.5% is used as the maximum 
PCT. EPA uses a maximum PCT for acute dietary risk analysis. The 
maximum PCT figure is the highest observed maximum value reported 
within the recent 6 years of available public and private market survey 
data for the existing use and rounded up to the nearest multiple of 5%.
    The Agency estimated the PCT for new uses as follows: 40% for 
oranges; 65% for table grapes; and 50% for spinach.
    EPA estimates PCT for new uses for tolfenpyrad based on the PCT of 
the dominant pesticide (i.e., the one with the greatest PCT) on that 
site over the three most recent years of available data. Comparisons 
are only made among pesticides of the same pesticide types (i.e., the 
dominant insecticide on the use site is selected for comparison with a 
new insecticide). The PCTs included in the analysis may be for the same 
pesticide or for different pesticides since the same or different 
pesticides may dominate for each year. Typically, EPA uses USDA/NASS as 
the source for raw PCT data because it is publicly available and does 
not have to be calculated from available data sources. When a specific 
use site is not surveyed by USDA/NASS, EPA uses proprietary data and 
calculates the estimated PCT.
    The estimated PCT for new uses, based on the average PCT of the 
market leader, is appropriate for use in the chronic dietary risk 
assessment. This method of estimating a PCT for a new use of a 
registered pesticide or a new pesticide produces a high-end estimate 
that is unlikely, in most cases, to be exceeded during the initial 5 
years of actual use. The predominant factors that bear on whether the 
estimated PCT for new uses could be exceeded are (1) the extent of pest 
pressure on the crops in question; (2) the pest spectrum of the new 
pesticide in comparison with the market leaders as well as whether the 
market leaders are well-established for this use; and (3) resistance 
concerns with the market leaders.

[[Page 1603]]

    All information currently available has been considered for 
tolfenpyrad, and it is the opinion of the Agency that it is unlikely 
that actual PCT for tolfenpyrad will exceed the estimated PCT for new 
uses during the next 5 years.
    The Agency believes that the three conditions discussed in Unit 
III.C.1.iv. have been met. With respect to Condition a, PCT estimates 
are derived from Federal and private market survey data, which are 
reliable and have a valid basis. The Agency is reasonably certain that 
the percentage of the food treated is not likely to be an 
underestimation. As to Conditions b and c, regional consumption 
information and consumption information for significant subpopulations 
is taken into account through EPA's computer-based model for evaluating 
the exposure of significant subpopulations including several regional 
groups. Use of this consumption information in EPA's risk assessment 
process ensures that EPA's exposure estimate does not understate 
exposure for any significant subpopulation group and allows the Agency 
to be reasonably certain that no regional population is exposed to 
residue levels higher than those estimated by the Agency. Other than 
the data available through national food consumption surveys, EPA does 
not have available reliable information on the regional consumption of 
food to which novaluron may be applied in a particular area.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for tolfenpyrad in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of tolfenpyrad. Further information regarding EPA 
drinking water models used in pesticide exposure assessment can be 
found at https://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the Pesticide Root Zone Model/Exposure Analysis Modeling 
System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI-
GROW) models, the estimated drinking water concentrations (EDWCs) of 
tolfenpyrad for acute exposures are 26.9 parts per billion (ppb) in 
surface water and 11 ppb for ground water; for chronic exposures, 12.2 
ppb in surface water and 11 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For the acute dietary risk 
assessment, the water concentration of value 26.9 ppb was used to 
assess the contribution to drinking water. For chronic dietary risk 
assessment, the water concentration of value 12.2 ppb was used to 
assess the contribution to drinking water.
    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).
    Tolfenpyrad is not registered for any specific use patterns that 
would result in residential exposure.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    EPA has not found tolfenpyrad to share a common mechanism of 
toxicity with any other substances, and tolfenpyrad does not appear to 
produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
tolfenpyrad 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 Web site at https://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the 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 seems to be 
increased qualitative susceptibility in the young in the developmental 
immunotoxicity study (DIT) in rats, there is low concern and there are 
no residual uncertainties regarding increased quantitative or 
qualitative prenatal and/or postnatal susceptibility for tolfenpyrad. 
When the DIT study is considered along with the reproduction study, the 
offspring toxicity in the DIT study was observed at the same dose as 
comparable maternal toxicity (moribundity/mortality) in the 
reproduction study. Therefore, EPA does not consider the isolated 
incident in the DIT a true indicator of qualitative susceptibility. 
Additionally, the effects observed in the DIT study are well-
characterized, a clear NOAEL was identified, and the endpoints chosen 
for risk assessment are protective of potential offspring effects.
    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 tolfenpyrad is complete.
    ii. There is no indication that tolfenpyrad is a neurotoxic 
chemical and there is no need for a developmental neurotoxicity study 
or additional UFs to account for neurotoxicity.
    iii. Although there is some evidence that tolfenpyrad may result in 
increased susceptibility, the concern for developmental or reproductive 
effects is low for the reasons contained in Unit III.D.2., and thus, a 
10X FQPA safety factor is not necessary to protect infants and 
children.
    iv. There are no residual uncertainties with regard to the exposure 
assessment. The acute dietary exposure assessment is based on high-end 
health protective residue levels (that account for parent and 
metabolites of concern), processing factors, and PCT assumptions 
(100%). The chronic dietary assessment incorporates significant 
refinement in that average residue values were used and projected PCT 
estimates were used for a few crops, the estimates are below the level 
of concern for all population subgroups because conservative 
assumptions, including the highly unlikely scenario that 100% of the 
planted acreage would be treated. Furthermore, conservative, upper-
bound assumptions were used to determine exposure through drinking 
water, such that these exposures have not been underestimated. There 
are no residential exposure scenarios at this time.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide 
exposures are safe by comparing aggregate exposure

[[Page 1604]]

estimates to the acute PAD (aPAD) and chronic PAD (cPAD). For linear 
cancer risks, EPA calculates the lifetime probability of acquiring 
cancer given the estimated aggregate exposure. Short-, intermediate-, 
and chronic-term risks are evaluated by comparing the estimated 
aggregate food, water, and residential exposure to the appropriate PODs 
to ensure that an adequate MOE exists.
    1. Acute risk. An acute aggregate risk assessment takes into 
account acute exposure estimates from dietary consumption of food and 
drinking water. For the acute assessment, the dietary risk for the U.S. 
population is estimated to be 62% of the aPAD. Children 3-5 years old 
are the highest-exposed population subgroup, with an estimated exposure 
at the 95th percentile of 0.076 mg/kg/day, which corresponds to 76% of 
the aPAD. Typically EPA has concerns when estimated exposures exceed 
100% of the acute or chronic population-adjusted dose (aPAD or cPAD). 
Acute dietary risk estimates are below EPA's level of concern for all 
population subgroups.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
tolfenpyrad from food and water will utilize 69% of the cPAD for 
children 1-2 years old, the population group receiving the greatest 
exposure. Based on the explanation in Unit III.C.3., regarding 
residential use patterns, chronic residential exposure to residues of 
topramezone is not expected.
    3. Short- and intermediate-term risk. Short- and intermediate-term 
aggregate exposure takes into account short- and intermediate-term 
residential exposure plus chronic exposure to food and water 
(considered to be a background exposure level). Short- and 
intermediate-term adverse effects were identified; however, tolfenpyrad 
is not registered for any use patterns that would result in short- or 
intermediate-term residential exposure. Because there is no short- or 
intermediate-term residential exposure and chronic dietary exposure has 
already been assessed under the appropriately protective cPAD (which is 
at least as protective as the POD used to assess short- and 
intermediate-term risk), no further assessment of short- or 
intermediate-term risk is necessary, and EPA relies on the chronic 
dietary risk assessment for evaluating short- and intermediate-term 
risk for tolfenpyrad.
    4. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, tolfenpyrad is not expected to pose a cancer risk to humans.
    5. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, or to infants and children from aggregate 
exposure to tolfenpyrad residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodologies are available in Pesticide 
Analytical Manual II (PAM II) for citrus and processed fractions 
(Method I), ginned cottonseed (Method IA), and bovine tissues and milk 
(Method II). Additionally, Method M-073 and M-936-95-2 have been 
validated by the Agency and submitted for inclusion in PAM II as 
enforcement methods. These five methods are adequate for enforcement of 
the tolerances on plants and livestock. Method M-073 and M-936-95-2 may 
be requested from: Chief, Analytical Chemistry Branch, Environmental 
Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone 
number: (410) 305-2905; email address: residuemethods@epa.gov.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with 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 MRLs for tolfenpyrad.

C. Revisions to Petitioned-For Tolerances

    Nearly all of the commodity definitions for the petitioned-for 
tolerances are inconsistent with the current Agency definitions and 
must be revised. For head lettuce, spinach, and celery subgroup 4B leaf 
petioles, EPA has concluded that a group tolerance of 30 ppm for 
vegetable, leafy, except Brassica, group 4 is appropriate. For all 
remaining crops (except prune, grape, milk, and cattle, goat, horse, 
and sheep fat), EPA revised the tolerance values based on residue data 
and the use of the Organization for Economic Cooperation and 
Development (OECD) tolerance calculation procedures.
    The submitted data for processed commodities are adequate and 
sufficient for the assessing and establishing tolerances associated 
with the proposed registration. EPA cannot determine the cause of the 
differences in the proposed tolerances for citrus dried pulp and oil, 
and raisin.
    EPA is establishing tolerances for meat and meat byproducts that 
differ from the requested livestock tolerances due to differences 
between the dietary burden calculation generated by the petitioner and 
that generated by the Agency.
    Finally, as EPA explained in its latest crop group rulemaking (77 
FR 50617, August 22, 2012) (FRL-9354-3), EPA will attempt to conform 
petitions seeking tolerances for crop groups to the newer established 
crop groups, rather than establish new tolerances under the pre-
existing crop groups, as part of its effort to eventually convert 
tolerances for any pre-existing crop group to tolerances with coverage 
under the revised crop group. Therefore, although the petitioner 
requested tolerances for crop groups 8 (fruiting vegetables), 10 
(citrus fruit), 11 (pome fruit), 12 (stone fruit), and 14 (tree nuts), 
EPA evaluated and is establishing tolerances for crop groups 8-10 
(fruiting vegetables), 10-10 (citrus fruit), 11-10 (pome fruit), 12-12 
(stone fruit), and 14-12 (tree nuts).

V. Conclusion

    Therefore, tolerances are established for residues of tolfenpyrad, 
(4-chloro-3-ethyl-1-methyl-N-[4-(p-tolyloxy) benzyl] pyrazole-5-
carboxamide in or on almond, hulls at 6.0 ppm; citrus, dried pulp at 
8.0 ppm; citrus, oil at 70 ppm; cotton, undelinted seed at 0.70 ppm; 
cotton, gin byproducts at 15 ppm; fruit, citrus, group 10-10 at 1.5 
ppm; fruit, stone, group 12-12 at 2.0 ppm; grape at 2.0 ppm; grape, 
raisin at 6.0 ppm; nut, tree, group 14-12 at 0.05 ppm; persimmon at 2.0 
ppm; plum, prune at 3.0 ppm; pomegranate at 2.0 ppm; potato at 0.01 
ppm; tea at 30 ppm; vegetable, leafy, except Brassica, group 4 at 30 
ppm; milk at 0.03. ppm; cattle, fat at 0.01 ppm; cattle, meat at 0.01 
ppm; cattle, meat byproducts at 0.35 ppm; goat, fat at 0.01 ppm; goat, 
meat at 0.01 ppm; goat, meat byproducts at 0.35 ppm; horse, fat at 0.01 
ppm; horse,

[[Page 1605]]

meat at 0.01 ppm; horse, meat by products at 0.35 ppm; sheep, fat at 
0.01 ppm; sheep, meat at 0.01 ppm; and sheep, meat byproducts at 0.35 
ppm.

VI. Statutory and Executive Order Reviews

    This final rule 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 final rule has 
been exempted from review under Executive Order 12866, this final rule 
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 final rule 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 final rule 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 final rule. In addition, 
this final rule does not impose any enforceable duty or contain any 
unfunded mandate as described under Title II of the Unfunded Mandates 
Reform Act of 1995 (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 of 1995 (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 23, 2013.
Steven Bradbury,
Director, 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. Add Sec.  180.675 to subpart C to read as follows:


Sec.  180.675  Tolfenpyrad; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of the 
insecticide tolfenpyrad, 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 
tolfenpyrad, 4-chloro-3-ethyl-1-methyl-N-[4-(p-
tolyloxy)benzyl]pyrazole-5-carboxamide.

------------------------------------------------------------------------
                 Commodity                        Parts per million
------------------------------------------------------------------------
Almond hulls..............................                           6.0
Citrus, dried pulp........................                           8.0
Citrus, oil...............................                          70.0
Cotton, gin byproducts....................                          15.0
Cotton, undelinted seed...................                          0.70
Fruit, stone, group 12-12.................                           2.0
Fruits, citrus, group 10-10...............                           1.5
Grape.....................................                           2.0
Grape, raisin.............................                           6.0
Nuts, tree, group 14-12...................                          0.05
Persimmon.................................                           2.0
Plum, prune...............................                           3.0
Pomegranate...............................                           2.0
Potato....................................                          0.01
Tea.......................................                          30.0
Vegetable, leafy, except Brassica, group 4                          30.0
------------------------------------------------------------------------

    (2) Tolerances are established for residues of the insecticide 
tolfenpyrad, including its metabolites and degradates, in or on the 
commodities in the following table. Compliance with the tolerance 
levels specified below is to be determined by measuring only the sum of 
tolfenpyrad, 4-chloro-3-ethyl-1-methyl-N-[4-(p-
tolyloxy)benzyl]pyrazole-5-carboxamide, and its metabolite 4-[4-[(4-
chloro-3-ethyl-1-methylpyrazol-5-yl)carbonylamino-methyl]phenoxy]-
benzoic acid, calculated as the

[[Page 1606]]

stoichiometric equivalent of tolfenpyrad.

------------------------------------------------------------------------
                 Commodity                        Parts per million
------------------------------------------------------------------------
Cattle, fat...............................                          0.01
Cattle, meat..............................                          0.01
Cattle, meat byproducts...................                          0.35
Goat, fat.................................                          0.01
Goat, meat................................                          0.01
Goat, meat byproducts.....................                          0.35
Horse, fat................................                          0.01
Horse, meat...............................                          0.01
Horse, meat byproducts....................                          0.35
Milk......................................                          0.03
Sheep, fat................................                          0.01
Sheep, meat...............................                          0.01
Sheep, meat byproducts....................                          0.35
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved].
    (c) Tolerances with regional registration. [Reserved].
    (d) Indirect or inadvertent residues. [Reserved].

[FR Doc. 2014-00163 Filed 1-8-14; 8:45 am]
BILLING CODE 6560-50-P