[Federal Register Volume 78, Number 224 (Wednesday, November 20, 2013)]
[Rules and Regulations]
[Pages 69562-69569]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-27680]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2012-0899; FRL-9902-44]


Fenpropathrin; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
fenpropathrin in or on multiple commodities which are identified and 
discussed later in this document. This regulation additionally removes 
several permanent tolerances as they will be superseded by the 
tolerances established by this document. Interregional Research Project 
Number 4 (IR-4) requested these tolerances under the Federal Food, 
Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective November 20, 2013. Objections and 
requests for hearings must be received on or before January 21, 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)

[[Page 69563]]

number EPA-HQ-OPP-2012-0899, 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), 
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 
http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Lois Rossi, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone 
number: (703) 305-7090; email address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's 
tolerance regulations at 40 CFR part 180 through the Government 
Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl. To access the OPPTS 
test guidelines referenced in this document electronically, please go 
to http://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-2012-0899 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 
January 21, 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-2012-0899, by one of 
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be CBI or other 
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerances

    In the Federal Register of February 15, 2013 (78 FR 11126) (FRL-
9378-4), 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 
2E8107) by IR-4,500 College Rd. East, Suite 201W., Princeton, NJ 08540. 
The petition requested that 40 CFR 180.466 be amended by establishing 
tolerances for residues of the insecticide fenpropathrin, alpha-cyano-
3-phenoxybenzyl 2,2,3,3-tetramethylcyclopropanecarboxylate, in or on 
barley, grain at 0.04 parts per million (ppm); barley, hay at 3.0 ppm; 
barley, straw at 2.0 ppm; berry, low-growing, subgroup 13-07G at 2.0 
ppm; bushberry subgroup 13-07B at 3.0 ppm; fruit, citrus, group 10-10 
at 2.0 ppm; fruit, pome, group 11-10 at 5.0 ppm; fruit, small vine 
climbing, except fuzzy kiwifruit, subgroup 13-07F at 5.0 ppm; and 
vegetable, fruiting, group 8-10 at 1.0 ppm. The petition additionally 
requested the removal of the following established tolerances in 40 CFR 
180.466 for fenpropathrin as they will be superseded by new tolerances, 
if established: Fruit, citrus, group 10; fruit, pome, group 11; 
bushberry subgroup 13B; grape; juneberry; salal; strawberry; and 
vegetable, fruiting, group 8.
    That document referenced a summary of the petition prepared on 
behalf of IR-4 by Valent USA Corporation, the registrant, which is 
available in the docket, http://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 
determined that the established tolerance for lingonberry will also be 
removed. The reason for this change is explained in Unit IV.C

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue. . . 
.''
    Consistent with FFDCA section 408(b)(2)(D), and the factors 
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available 
scientific data and other relevant information in support of this 
action. EPA has sufficient data to assess the hazards of and to make a 
determination on aggregate exposure for fenpropathrin including 
exposure resulting from the

[[Page 69564]]

tolerances established by this action. EPA's assessment of exposures 
and risks associated with fenpropathrin 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.
    Fenpropathrin 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. 
Type I pyrethroids, which lack an alpha-cyano moiety, induce in rats a 
syndrome consisting of aggressive sparring, altered sensitivity to 
external stimuli, hyperthermia, and fine tremor progressing to whole-
body tremor and prostration (T-syndrome). Type II pyrethroids, which 
contain an alpha-cyano moiety, produce in rats a syndrome that includes 
pawing, burrowing, salivation, hypothermia, and coarse tremors leading 
to choreoathetosis (CS-syndrome). Fenpropathrin is a mixed-type 
pyrethroid because the biochemical responses and resulting clinical 
signs of neurotoxicity are intermediate between those of Type I and 
Type II pyrethroids. The adverse outcome pathway shared by pyrethroids 
involves the ability to interact with voltage-gated sodium channels in 
the central and peripheral nervous systems, leading to changes in 
neuron firing and, ultimately, neurotoxicity.
    Fenpropathrin exhibits high acute toxicity via the oral and dermal 
routes but low toxicity via the inhalation route of exposure. 
Fenpropathrin is a mild eye irritant, but does not cause dermal 
irritation or skin sensitization. Toxicological effects characteristic 
of pyrethroids were seen in most of the experimental toxicology studies 
including the acute, subchronic, and developmental neurotoxicity 
studies, subchronic studies in the rat and dog, the chronic 
carcinogenicity study in the rat, the developmental studies in the rat 
and rabbit, and in the 3-generation reproduction study in rats. Tremors 
were the most common indication of neurotoxicity; however, ataxia, 
increased sensitivity (e.g., heightened response) to external stimuli, 
convulsions, and increased auditory startle response were also 
observed.
    In developmental toxicity studies in rats and rabbits, maternal 
toxicity included neurological effects such as ataxia, sensitivity to 
external stimuli, tremors in the rat, and flicking of forepaws in the 
rabbit. Developmental effects were limited to incomplete or 
asymmetrical ossification of sternebrae at the maternally toxic dose in 
the rat. There were no developmental effects in the rabbit. In a 3-
generation reproduction study in the rat, maternal and offspring 
effects were observed at the mid- and high-dose. At the high dose, 
maternal effects included increased deaths and clinical signs of 
toxicity (tremors, muscle twitches, and increased sensitivity) during 
lactation. Pup deaths were noted at this level. At the mid-dose, 
minimal signs of treatment-related effects were observed for both 
adults and pups, reducing concern for quantitative or qualitative 
sensitivity. There were no indications of immunotoxicity in any of the 
guideline studies, including the immunotoxicity study in rats.
    There was no evidence of carcinogenicity in either the rat or mouse 
long-term dietary studies, nor was there any mutagenic activity in 
bacteria or cultured mammalian cells. Fenpropathrin has been classified 
as ``not likely to be carcinogenic to humans.'' Specific information on 
the studies received and the nature of the adverse effects caused by 
fenpropathrin as well as the toxicological points of departure (POD) 
derived from the BMDL (statistical lower confidence limit on the dose 
at the benchmark dose) from the toxicity studies can be found at http://www.regulations.gov in document ``Fenpropathrin. Human Health Risk 
Assessment for the Proposed Section 3 Registration on Barley and the 
Request to Update Several Existing Crop Groups with Revised Crop 
Grouping Definitions'' starting at p. 12, in docket ID number EPA-HQ-
OPP-2012-0899.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological 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. For fenopropathrin, the PODs are developed 
based on a careful analysis of the doses in each toxicological study; a 
benchmark dose analysis was conducted to derive the BMDL. 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://www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for fenpropathrin used for 
human risk assessment is discussed in Unit III.B. of the final rule 
published in the Federal Register of November 28, 2012 (77 FR 70902) 
(FRL-9366-1).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to fenpropathrin, EPA considered exposure under the 
petitioned-for tolerances as well as all existing fenpropathrin 
tolerances in 40 CFR 180.466. EPA assessed dietary exposures from 
fenpropathrin 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 fenpropathrin. In estimating acute dietary exposure, EPA used food 
consumption information from the United States Department of 
Agriculture (USDA) 2003-2008 National Health and Nutrition Examination 
Survey, What We Eat in America, (NHANES/WWEIA). As to residue levels in 
food, EPA utilized percent crop treated (PCT) estimates and tolerance 
level residues, distributions of field trial values, and distributions 
of Pesticide Data Program (PDP) monitoring data.
    Residue distributions were used for the commodities that made the 
most significant contributions to the risk estimates (i.e., the ``risk 
drivers''). Monitoring data were used for risk drivers when they were 
available; however, field trial data were used for the remaining risk 
drivers. Distributions of monitoring data values were used for the 
following risk drivers: Apple juice, apples, blackberries, blueberries, 
broccoli, cauliflower, Chinese mustard cabbage, grape juice, grapes, 
huckleberries, oranges, pears, raspberries, squash, strawberries, 
tangerines, and watermelon. Monitoring

[[Page 69565]]

data from the years 2007 through 2010, inclusive, were used. Broccoli 
PDP data were translated to Chinese mustard cabbage and cauliflower. 
Orange PDP data were translated to tangerines. Blueberry PDP data were 
translated to blackberries, huckleberries, and raspberries. Finally, 
strawberry PDP data were translated to cranberries. Distributions of 
field trial data were used for apricot juice, apricots, Brussels 
sprouts, cabbage, cherries, cherry juice, Chinese napa cabbage, 
cucumbers, grapefruit, grapefruit juice, guava, mango, mango juice, 
nectarines, olives, papaya, papaya juice, passion fruit, passion fruit 
juice, peach juice, peaches, plums, prune plum juice, prune plums, 
tomato juice, and tomatoes. For most processed commodities, DEEM 
(Dietary Exposure Evaluation Model) default processing factors were 
used for those commodities for which they were available. In some 
cases, empirical processing factors were used.
    ii. Chronic exposure. Based on the data summarized in Unit III.A., 
there is no increase in hazard from repeated exposures to 
fenpropathrin; the acute dietary exposure assessment is protective for 
chronic dietary exposures because acute exposure levels are higher than 
chronic exposure levels. Accordingly, a dietary exposure assessment for 
the purpose of assessing chronic dietary risk was not conducted.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that fenpropathrin does not pose a cancer risk to humans. 
Therefore, a dietary exposure assessment for the purpose of assessing 
cancer risk is unnecessary.
    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 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.
    The Agency estimated the PCT for existing uses as follows: Apples, 
15%; apricots 2.5%; blueberries, 2.5%; broccoli, 2.5%; Brussels 
sprouts, 10%; cabbage, 2.5%; cauliflower, 2.5%; cherries, 5%; cotton, 
2.5%; cucumbers, 2.5%; grapefruit, 35%; grapes, 10%; nectarines, 2.5%; 
oranges, 35%; peaches, 2.5%; pears, 10%; plums, 2.5%; prune plums, 
2.5%; squash, 2.5%; strawberries, 50%; tangerines, 15%; tomatoes, 10%; 
and watermelons, 2.5%.
    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 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 fenpropathrin 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 fenpropathrin in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of fenpropathrin. Further information regarding EPA 
drinking water models used in pesticide exposure assessment can be 
found at http://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the First Index Reservoir Screening Tool (FIRST), 
Screening Concentration in Ground Water (SCI-GROW) models, the 
estimated drinking water concentrations (EDWCs) of fenpropathrin for 
acute exposures are estimated to be 10.3 parts per billion (ppb) for 
surface water and 0.005 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For acute dietary risk 
assessment, the water concentration value of 10.3 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). Fenpropathrin 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

[[Page 69566]]

pesticide's residues and ``other substances that have a common 
mechanism of toxicity.''
    The Agency is required to consider the cumulative risks of 
chemicals sharing a common mechanism of toxicity. The Agency has 
determined that the pyrethroids and pyrethrins, including 
fenpropathrin, share a common mechanism of toxicity. The members of 
this group share the ability to interact with voltage-gated sodium 
channels, ultimately leading to neurotoxicity. The cumulative risk 
assessment for the pyrethroids/pyrethrins was published in the Federal 
Register of November 9, 2011 (76 FR 69726) (FRL 8888-9), and is 
available at http://www.regulations.gov in docket ID number EPA-HQ-OPP-
2011-0746. Further information about the determination that pyrethroids 
and pyrethrins share a common mechanism of toxicity may be found in 
document ID number EPA-HQ-OPP-2008-0489-0006.
    Fenpropathrin was included in the cumulative risk assessment for 
pyrethrins and pyrethroids. The proposed new uses of fenpropathrin will 
not significantly impact the cumulative assessment because, in the 
cumulative assessment, residential exposure was the greatest 
contributor to the total exposure. As there are no new residential uses 
for the fenpropathrin, the proposed new uses will have no impact on the 
residential component of the cumulative risk estimates.
    Dietary exposures make a minor contribution to 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 dietary exposure assessment for the single 
chemical included conservative assumptions, using field trial data for 
many commodities, including the proposed new uses with the assumption 
of 100 PCT, and the most sensitive apical endpoint in the fenpropathrin 
hazard database was selected to derive the POD. Additionally, the POD 
selected for fenpropathrin is specific to the fenpropathrin, whereas 
the POD selected for the cumulative assessment was based on common 
mechanism of action data that are appropriate for all 20 pyrethroids 
included in the cumulative assessment.
    For information regarding EPA's efforts to evaluate the risk of 
exposure to pyrethroids, refer to http://www.epa.gov/oppsrrd1/reevaluation/pyrethroids-pyrethrins.html.

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 Food Quality 
Protection Act Safety Factor (FQPA SF). In applying this provision, EPA 
either retains the default value of 10X, or uses a different additional 
SF when reliable data available to EPA support the choice of a 
different factor.
    2. Prenatal and postnatal sensitivity. The fenpropathrin toxicity 
database includes developmental toxicity studies in the rat and rabbit, 
a 3-generation reproduction study in the rat, and a developmental 
neurotoxicity (DNT) study in rats. There was no evidence of increased 
qualitative or quantitative susceptibility noted in any of these 
studies. This lack of susceptibility is consistent with the results of 
the guideline pre- and postnatal testing for other pyrethroid 
pesticides.
    High-dose LD50 studies (studies assessing what dose 
results in lethality to 50% of the tested population) in the scientific 
literature indicate that pyrethroids can result in increased 
quantitative sensitivity in the young, specifically in the form of 
neurotoxicity. Examination of pharmacokinetic and pharmacodynamic data 
indicates that the sensitivity observed at high doses is related to 
pyrethroid age-dependent pharmacokinetics--the activity of enzymes 
associated with the metabolism of pyrethroids. With otherwise 
equivalent administered doses for adults and juveniles, predictive 
pharmacokinetic models indicate that the differential adult-juvenile 
pharmacokinetics will result in a 3X greater dose at the target organ 
in juveniles compared to adults. No evidence of increased quantitative 
or qualitative susceptibility was seen in the pyrethroid scientific 
literature related to pharmacodynamics (the effect of pyrethroids at 
the target tissue) with regard to differences between juveniles and 
adults. Specifically, there are in vitro pharmacodynamic data and in 
vivo data indicating similar responses between adult and juvenile rats 
at low doses and data indicating that the rat is a conservative model 
compared to the human based on species-specific pharmacodynamics of 
homologous sodium channel isoforms in rats and humans.
    3. Conclusion. EPA is reducing the FQPA SF to 3X for infants and 
children less than 6 years of age. For the general population, 
including children greater than 6 years of age, EPA is reducing the 
FQPA SF to 1X. The decisions regarding the FQPA SFs being used are 
based on the following considerations:
    i. While the database is considered to be complete with respect to 
the guideline toxicity studies for fenpropathrin, EPA lacks additional 
data to fully characterize the potential for juvenile sensitivity to 
neurotoxic effects of pyrethroids. In light of the literature studies 
indicating a possibility of increased sensitivity in juvenile rats at 
high doses, EPA identified a need, and requested proposals for, 
additional non-guideline studies to evaluate the potential for 
sensitivity in juvenile rats. A group of pyrethroid registrants is 
currently conducting those studies. Pending the results of those 
studies, however, the available toxicity studies for fenpropathrin can 
be used to characterize toxic effects including potential developmental 
and reproductive toxicity, immunotoxicity, and neurotoxicity. 
Acceptable developmental toxicity studies in rats and rabbits, 
reproduction studies in rats, neurotoxicity studies (acute, subchronic, 
and developmental) in rats, and immunotoxicity studies in rats are 
available. In addition, a route-specific dermal toxicity study is 
available, and the inhalation study has been waived.
    ii. After reviewing the extensive body of data and peer-reviewed 
literature on pyrethroids, the Agency has reached a number of 
conclusions regarding fetal and juvenile sensitivity for pyrethroids, 
including the following:
     Based on an evaluation of over 70 guideline toxicity 
studies for 24 pyrethroids submitted to the Agency, including prenatal 
developmental toxicity studies in rats and rabbits, and pre- and 
postnatal multi-generation reproduction toxicity studies and DNTs in 
rats in support of pyrethroid registrations, there is no evidence that 
pyrethroids directly impact developing fetuses. None of the studies 
show any indications of fetal toxicity at doses that do not cause 
maternal toxicity.
     Increased susceptibility was seen in offspring animals in 
the DNT study with the pyrethroid zeta-cypermethrin (decreased pup body 
weights) and DNT and reproduction studies with another pyrethroid beta-
cyfluthrin (decreased body weights and tremors). However, the 
reductions in body weight and the other non-specific effects occur at

[[Page 69567]]

higher doses than neurotoxicity, the effect of concern for pyrethroids. 
The available developmental and reproduction guideline studies in rats 
with zeta-cypermethrin did not show increased sensitivity in the young 
to neurotoxic effects. Overall, findings of increased sensitivity in 
juvenile animals in pyrethroid studies are rare. Therefore, the 
residual concern for the postnatal effects is reduced.
     High-dose LD50 studies (studies assessing what 
dose results in lethality to 50% of the tested population) in the 
scientific literature indicate that pyrethroids can result in increased 
quantitative sensitivity to juvenile animals. Examination of 
pharmacokinetic and pharmacodynamic data indicates that the sensitivity 
observed at high doses is related to pyrethroid age-dependent 
pharmacokinetics--the activity of enzymes associated with the 
metabolism of pyrethroids. Furthermore, a rat physiologically-based 
pharmacokinetic (PBPK) model predicts a 3-fold increase of pyrethroid 
concentration in juvenile brain compared to adults at high doses.
     In vitro pharmacodynamic data and in vivo data 
indicate that adult and juvenile rats have similar responses to 
pyrethroids at low doses and therefore juvenile sensitivity is not 
expected at relevant environmental exposures. Further, data also show 
that the rat is a conservative model compared to the human based on 
species-specific pharmacodynamics of homologous sodium channel 
isoforms.
    iii. There are no residual uncertainties identified in the exposure 
databases. Although the acute dietary exposure estimates are refined, 
as described in Unit III.C.1.i., the exposure estimates will not 
underestimate risk for the established and proposed uses of 
fenpropathrin. The residue levels used are based on distributions of 
residues from field trial data, monitoring data reflecting actual 
residues found in the food supply, and tolerance-level residues for 
several commodities; the use of estimated PCT information; and, when 
appropriate, processing factors measured in processing studies or 
default high-end factors representing the maximum concentration of 
residue into a processed commodity. EPA made conservative (protective) 
assumptions in the ground and surface water modeling used to assess 
exposure to fenpropathrin in drinking water. These assessments will not 
underestimate the exposure and risks posed by fenpropathrin.
    Taking all of this information into account, EPA has reduced the 
FQPA SF for women of child-bearing age because there is no evidence in 
the over 70 guideline toxicity studies submitted to the Agency that 
pyrethroids directly impact developing fetuses. Additionally, none of 
the studies show any indications of fetal toxicity at doses that do not 
cause maternal toxicity. Because there remains some uncertainty as to 
juvenile sensitivity due to the findings in the high-dose 
LD50 studies, EPA is retaining a 3X FQPA SF for infants and 
children less than 6 years of age. By age 6, the metabolic system is 
expected to be at or near adult levels thus reducing concerns for 
potential age-dependant sensitivity related to pharmacokinetics; 
therefore for children over 6, 1X is appropriate. Although EPA is 
seeking additional data to further characterize the potential 
neurotoxicity for pyrethroids, EPA has reliable data that show that 
reducing the FQPA SF to 3X will protect the safety of infants and 
children less than 6 years old. These data include:
    a. Data from developmental, reproductive, and DNT guideline studies 
with fenpropathrin that show no sensitivity.
    b. Data showing that the potential sensitivity at high doses is 
likely due to pharmacokinetics.
    c. A rat PBPK model predicting a 3-fold increase of pyrethroid 
concentration in juvenile brain compared to adults at high doses due to 
age-dependent pharmacokinetics.
    d. Data indicating that the rat is a conservative model compared to 
the human based on species-specific pharmacodynamics of homologous 
sodium channel isoforms.
    For several reasons, EPA concludes these data show that a 3X factor 
is protective of the safety of infants and children less than 6 years 
of age. First, it is likely that the extensive guideline studies with 
pyrethroids, which indicate that increased sensitivity in juvenile 
animals in pyrethroid studies is rare, better characterize the 
potential sensitivity of juvenile animals than the LD50 
studies. The high doses that produced juvenile sensitivity in the 
literature studies are well above normal dietary or residential 
exposure levels of pyrethroids to juveniles and lower levels of 
exposure anticipated from dietary and residential uses are not expected 
to overwhelm the juvenile's ability to metabolize pyrethroids, as 
occurred with the high doses used in the literature studies. The fact 
that a greater sensitivity to the neurotoxicity of pyrethroids is not 
found in guideline studies following in utero exposures (based on 76 
studies for 24 pyrethroids) supports this conclusion, despite the 
relatively high doses used in the studies. Second, in vitro data 
indicate similar pharmacodynamic response to pyrethroids between 
juvenile and adult rats. Finally, as indicated, pharmacokinetic 
modeling only predicts a 3X difference between juveniles and adults. 
Therefore, the FQPA SF of 3X is protective of potential juvenile 
sensitivity.
    Further information about the reevaluation of the FQPA SF for 
pyrethroids may be found in document ID number EPA-HQ-OPP-2011-0746-
0011.

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 fenpropathrin will occupy 93% of the aPAD for children 1-2 years 
old, the population group receiving the greatest exposure from the 
dietary assessment for infants and children less than 6 years old; and 
20% of the aPAD for children 6 to 12 years old, the population group 
receiving the greatest exposure from the dietary assessment for the 
general population other than children less than 6 years old.
    2. Chronic risk. Based on the data summarized in Unit III.A., there 
is no increase in hazard with increasing dose duration. Therefore, the 
acute aggregate assessment is protective of potential chronic aggregate 
exposures.
    3. Short-term risk. Short-term aggregate exposure takes into 
account short-term residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level). A short-term 
adverse effect was identified; however, fenpropathrin is not registered 
for any use patterns that would result in short-term residential 
exposure. Short-term risk is assessed based on short-term residential 
exposure plus chronic dietary exposure. Because there is no short-term 
residential exposure and acute dietary exposure has already been 
assessed under the appropriately protective aPAD (which is at least as

[[Page 69568]]

protective as the POD used to assess short-term risk), no further 
assessment of short-term risk is necessary, and EPA relies on the acute 
dietary risk assessment for evaluating short-term risk for 
fenpropathrin.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level). Because no intermediate-term adverse effect was identified, 
fenpropathrin 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, fenpropathrin is not expected to pose a cancer risk to humans.
    6. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population or to infants and children from aggregate 
exposure to fenpropathrin residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology utilizing gas chromatography with 
electron capture detector (GC/ECD), Residue Method Numbers RM-22-4 
(plants) and RM-22A-1 (animals), is available to enforce the tolerance 
expression.
    The method may be requested from: Chief, Analytical Chemistry 
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 
20755-5350; telephone number: (410) 305-2905; email address: 
[email protected].

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint United Nations 
Food and Agriculture Organization/World Health Organization food 
standards program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level.
    Codex has established MRLs for tomatoes, sweet peppers, dried chili 
peppers, eggplant, grapes, and pome fruits. The MRLs for tomatoes, 
sweet peppers, grapes, and pome fruits are harmonized with the U.S. 
tolerances for the corresponding crop groups or subgroups. Codex MRLs 
for dried chili peppers (10 ppm) and eggplant (0.2 ppm) cannot be 
harmonized with the U.S. tolerance for the fruiting vegetable crop 
group (1.0 ppm), of which those commodities are a part. The Codex MRL 
for eggplant is lower than the recommended corresponding U.S. 
tolerance. Because the permitted domestic use on eggplant in accordance 
with the approved pesticide label results in residue levels higher than 
the Codex MRLs, the U.S. tolerance cannot be harmonized (lowered) since 
doing so would result in residues in excess of the approved tolerance 
in spite of use consistent with label directions. Concerning dried 
chili peppers, EPA, under its Residue Chemistry Test Guidelines (OPPTS 
860.1000), does not set tolerances for dried chili peppers. Rather, 
residues on dried chili peppers would be covered under tolerances for 
non-bell peppers, which, for this chemical, are captured by the 
fruiting vegetable crop group tolerance. Under that U.S. tolerance, 
residues of fenpropathrin on dried chili peppers would be covered up to 
1.0 ppm; residues in excess of that level would only be covered if EPA 
established a separate tolerance for them. At this time, however, EPA 
does not have data to support establishing a tolerance for dried chili 
peppers at 10 ppm.

C. Revisions to Petitioned-For Tolerances

    Based on the data submitted with the petition, EPA is also removing 
the established tolerance for lingonberry. The Agency is removing this 
tolerance because it will be superseded by the new tolerance for 
bushberry subgroup 13-07B, established by this document. The removal 
does not substantively affect whether residues of fenpropathrin may be 
present on lingonberry. The new bushberry subgroup 13-07B tolerance is 
at the same level as the lingonberry tolerance being removed--3.0 ppm.

V. Conclusion

    Therefore, tolerances are established for residues of 
fenpropathrin, alpha-cyano-3-phenoxybenzyl 2,2,3,3-
tetramethylcyclopropanecarboxylate, in or on barley, grain at 0.04 ppm; 
barley, hay at 3.0 ppm; barley, straw at 2.0 ppm; berry, low-growing, 
subgroup 13-07G at 2.0 ppm; bushberry subgroup 13-07B at 3.0 ppm; 
fruit, citrus, group 10-10 at 2.0 ppm; fruit, pome, group 11-10 at 5.0 
ppm; fruit, small vine climbing, except fuzzy kiwifruit, subgroup 13-
07F at 5.0 ppm; and vegetable, fruiting, group 8-10 at 1.0 ppm. 
Additionally, this document removes the established tolerances of 
fenpropathrin in or on fruit, citrus, group 10; fruit, pome, group 11; 
bushberry subgroup 13B; grape; juneberry; lingonberry; salal; 
strawberry; and vegetable, fruiting, group 8.

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 tolerances 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

[[Page 69569]]

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: November 7, 2013.
Daniel J. Rosenblatt,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

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


0
2. In Sec.  180.466:
0
a. Remove the entries for ``Bushberry subgroup 13B,'' ``Fruit, citrus, 
group 10,'' ``Fruit, pome, group 11,'' ``Grape,'' ``Juneberry,'' 
``Lingonberry,'' ``Salal,'' ``Strawberry,'' and ``Vegetable, fruiting, 
group 8'' from the table in paragraph (a).
0
b. Add alphabetically the following entries to the table in paragraph 
(a).
    The amendments read as follows:


Sec.  180.466  Fenpropathrin; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Barley, grain.............................................          0.04
Barley, hay...............................................          3.0
Barley, straw.............................................          2.0
Berry, low growing, subgroup 13-07G.......................          2.0
 
                                * * * * *
Bushberry subgroup 13-07B.................................          3.0
 
                                * * * * *
Fruit, citrus, group 10-10................................          2.0
Fruit, pome, group 11-10..................................          5.0
Fruit, small vine climbing, except fuzzy kiwifruit,                 5.0
 subgroup 13-07F..........................................
 
                                * * * * *
Vegetable, fruiting, group 8-10...........................          1.0
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2013-27680 Filed 11-19-13; 8:45 am]
BILLING CODE 6560-50-P