Document ID: EPA-HQ-OPP-2009-0644-0004
Agency: epa
Document Type: Rule
Title: Pesticide Tolerances: Fenpropathrin
Posted Date: 2012-11-28T05:00Z

[Federal Register Volume 77, Number 229 (Wednesday, November 28, 2012)]
[Rules and Regulations]
[Pages 70902-70908]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-28721]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2009-0644; FRL-9366-1]

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. 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 28, 2012. Objections and 
requests for hearings must be received on or before January 28, 2013, 
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-2009-0644, 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: Laura Nollen, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone 
number: (703) 305-7390; email address: nollen.laura@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 http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an 
objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2009-0644 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 28, 2013. 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-2009-0644, 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.htm.

Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-for Tolerance

    In the Federal Register of October 7, 2009 (74 FR 51597) (FRL-8792-
7), EPA issued a notice pursuant to FFDCA section 408(d)(3), 21 U.S.C. 
346a(d)(3), announcing the filing of a pesticide petition (PP 9E7594) 
by IR-4, 500 College Road East, Suite 201W, Princeton, NJ 08540. The 
petition requested that 40 CFR 180.466 be amended by establishing 
tolerances for

[[Page 70903]]

residues of the insecticide fenpropathrin, alpha-cyano-3-phenoxy-benzyl 
2,2,3,3-tetramethylcyclopropanecarboxylate, in or on acerola, feijoa, 
guava, jaboticaba, passionfruit, starfruit and wax jambu at 1.5 parts 
per million (ppm); longan, lychee, pulasan, rambutan and Spanish lime 
at 3.0 ppm; atemoya, biriba, cherimoya, custard apple, ilama, soursop 
and sugar apple, at 1.0 ppm; and tea at 2.0 ppm. That notice 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 
revised the proposed tolerances for several commodities. The Agency has 
also revised the tolerance expression for all established commodities 
to be consistent with current Agency policy. The reasons for these 
changes are 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 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 induce in rats a syndrome consisting of aggressive 
sparring, altered sensitivity to external stimuli, hyperthermia, and 
fine tremors, progressing to whole-body tremors, 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 Type I 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. There were 
no indications of immunotoxicity in any of the guideline studies, 
including the immunotoxicity study in rats. 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 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 no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in the document, ``Fenpropathrin. Human Health Risk 
Assessment for Section 3 Registration on Tropical Fruit and a Request 
for a Tolerance without U.S. Registration on Tea'' at pp 40-45 in 
docket ID number EPA-HQ-OPP-2009-0644.

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

[[Page 70904]]

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 shown in 
the following Table.

  Table--Summary of Toxicological Doses and Endpoints for Fenpropathrin for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                     Point of departure and
         Exposure/scenario             uncertainty/safety       RfD, PAD for risk      Study and toxicological
                                             factors               assessment                  effects
----------------------------------------------------------------------------------------------------------------
Acute dietary (General population,   Wolansky BMDL1SD = 5.0  aRfD = 0.05 mg/kg/day.  Wolansky BMD1SD = 6.4 mg/kg
 including children >= 6 years old).  mg/kg.                 aPAD = 0.05 mg/kg/day.   based on decreased motor
                                     UFA = 10X.............                           activity.
                                     UFH = 10X.............
                                     FQPA SF = 1X..........
Acute dietary (< 6 years old)......  Wolansky BMDL1SD = 5.0  aRfD = 0.05 mg/kg/day.  Wolansky BMD1SD = 6.4 mg/kg
                                      mg/kg.                 aPAD = 0.017 mg/kg/      based on decreased motor
                                     UFA = 10X.............   day..                   activity.
                                     UFH = 10X.............
                                     FQPA SF = 3X..........
----------------------------------------------------------------------------------------------------------------
Chronic dietary (All populations)..     Because of the rapid reversibility of the most sensitive neurotoxicity
                                       endpoint used for quantifying risks, there is no increase in hazard with
                                         increasing dosing duration. Therefore, the acute dietary endpoint is
                                       protective of the endpoints from repeat dosing studies, including chronic
                                                                  dietary exposures.
Cancer (Oral, dermal, inhalation)..    Fenpropathrin has been classified as ``not likely to be carcinogenic to
                                                       humans.'' Cancer risk is not of concern.
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. mg/kg/day = milligram/kilogram/day. PAD = population
  adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor. UFA = extrapolation
  from animal to human (interspecies). UFH = potential variation in sensitivity among members of the human
  population (intraspecies). BMD = Benchmark Dose Analysis. BMD1SD = dose level where effect is 1SD from control
  value. BMDL1SD = lower 95% confidence limit of the BMD value.

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 U.S. Department of Agriculture (USDA) 
1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by 
Individuals (CSFII). 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. Distributions of 
USDA's PDP monitoring data from 2007 through 2010 were used for 
broccoli (translated to Chinese mustard cabbage and cauliflower), 
watermelon, squash, oranges (translated to tangerines), apples, apple 
juice, pears, blueberries (translated to huckleberries), grapes, grape 
juice, and strawberries. Distributions of field trial data were used 
for cherries, peaches, plums, grapefruit, raspberries, blackberries, 
apricots, cabbage, papaya, olives, tomatoes, cucumbers, Brussels 
sprouts, and guava. Tolerance-level residues were assumed for all other 
commodities having existing or proposed tolerances. Dietary Exposure 
Evaluation Model (DEEM) 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 bincrease 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 percent crop treated (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.

[[Page 70905]]

     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 U.S. 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 to 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 1. 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) and 
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 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 November 
9, 2011 issue of the Federal Register (76 FR 69726) (FRL 8888-9), and 
is available at http://www.regulations.gov in the public docket, 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: EPA-HQ- OPP-2008-0489-0006.
    The Agency has conducted a quantitative analysis of the proposed 
tolerances for fenpropathrin and has determined that it will not 
contribute significantly or change the overall findings presented in 
the pyrethroid cumulative risk assessment. In the cumulative assessment 
for pyrethroids, residential exposures were the greatest contributor to 
the total exposure. As there are no residential uses for 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 the total pyrethroid 
exposure. The dietary exposure assessment performed in support of the 
pyrethroid cumulative assessment was much more highly refined than that 
performed for the single chemical, fenpropathrin. In addition, for the 
fenpropathrin risk assessment, the most sensitive apical endpoint in 
the fenpropathrin database was selected to derive the POD. 
Additionally, the POD selected for fenpropathrin is specific to 
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. The proposed 
food uses of fenpropathrin will not contribute significantly or change 
the overall findings in the pyrethroid cumulative risk assessment, as 
the dietary risks are a minor component of total pyrethroid cumulative 
risk. 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.

[[Page 70906]]

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 safety factor 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 rats and rabbits 
and a 3-generation reproduction study in rats, 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 prenatal and postnatal testing for other pyrethroid 
pesticides.
    There are several in vitro and in vivo studies that indicate 
pharmacodynamic contributions to pyrethroid toxicity are not age-
dependent. A study of the toxicity database for pyrethroid chemicals 
also noted no residual uncertainties regarding age-related 
sensitivities for the young, based on the absence of prenatal 
sensitivity observed in 76 guideline studies for 24 pyrethroids and the 
scientific literature. However, high-dose studies at LD50 
doses noted that younger animals were more susceptible to the toxicity 
of pyrethroids. These age-related differences in toxicity are 
principally due to age-dependent pharmacokinetics; the activity of 
enzymes associated with the metabolism of pyrethroids increases with 
age. Nonetheless, the typical environmental exposures to pyrethroids 
are not expected to overwhelm the clearance capacity in juveniles. In 
support, at a dose of 4.0 milligrams/kilogram (mg/kg) for deltamethrin 
(near the Wolansky study LOAEL value of 3.0 mg/kg for deltamethrin), 
the change in the acoustic startle response was similar between adult 
and young rats.
    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 SF being used are based 
on the following considerations:
    i. The toxicity database for fenpropathrin is not complete. While 
the database is considered to be complete with respect to the guideline 
toxicity studies for fenpropathrin, EPA lacks additional data to 
address the potential for juvenile sensitivity to all pyrethroids. In 
light of the literature studies indicating a possibility of increased 
sensitivity to fenpropathrin in juvenile rats at high doses, EPA has 
requested proposals for study protocols which could identify and 
quantify fenpropathrin's potential juvenile sensitivity. The reasons 
discussed in Unit III.D.3.ii, and the uncertainty regarding the 
protectiveness of the intraspecies uncertainty factor raised by the 
literature studies warrant application of an additional 3X for risk 
assessments for infants and children less than 6 years of age.
    ii. There is no evidence that fenpropathrin results in increased 
susceptibility in in utero rats or rabbits in the prenatal 
developmental studies or in young rats in a 3-generation rat 
reproduction study. This is consistent with the results of the 
guideline pre- natal and postnatal testing for other pyrethroid 
pesticides. There are, however, high dose LD50 studies 
(studies assessing what dose results in lethality to 50 percent of the 
tested population) in the scientific literature indicating that 
pyrethroids can result in increased quantitative sensitivity in the 
young. 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. Predictive 
pharmacokinetic models indicate that the differential adult-juvenile 
pharmacokinetics will result in otherwise equivalent administered doses 
for adults and juveniles producing 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) both 
with regard to interspecies differences between rats and humans and 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.
    In light of the high dose literature studies showing juvenile 
sensitivity to pyrethroids and the absence of the requested data on 
juvenile sensitivity to pyrethroids, EPA is retaining a 3X additional 
safety factor as estimated by pharmacokinetic modeling. For several 
reasons, EPA concludes there are reliable data showing that a 3X factor 
is protective of the safety of infants and children. First, the high 
doses that produced juvenile sensitivity in the literature studies are 
well above normal dietary exposure levels of pyrethroids to juveniles 
and these lower levels of exposure are not expected to overwhelm the 
ability to metabolize pyrethroids as occurred with the high doses used 
in the literature studies. This is confirmed by the lack of a finding 
of increased sensitivity in prenatal and postnatal guideline studies in 
any pyrethroid, including fenpropathrin, despite the relatively high 
doses used in those studies. Second, the portions of both the inter- 
and intraspecies uncertainty factors that account for potential 
pharmacodynamic differences (generally considered to be approximately 
3X for each factor) are likely to overstate the risk of inter- and 
intraspecies pharmacodynamic differences given the data showing 
similarities in pharmacodynamics between juveniles and adults and 
between humans and rats. Finally, as indicated, pharmacokinetic 
modeling only predicts a 3X difference between juveniles and adults.
    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.
    Further information about the reevaluation of the FQPA SF for

[[Page 70907]]

pyrethroids may be found in document ID: EPA-HQ-OPP-2011-0746-0011, at 
regulations.gov.

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-term, intermediate-term, 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 97% of the aPAD for children 3 to 5 years 
old, the population group receiving the greatest exposure from the 
dietary assessment for infants and children less than 6 years old; and 
27% 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 dosing duration. Furthermore, 
chronic dietary exposures will be lower than acute exposures. 
Therefore, the acute aggregate assessment is protective of potential 
chronic aggregate exposures.
    3. Short-term risk. 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 
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

    An adequate enforcement methodology utilizing gas chromatography 
with electron capture detection (GC/ECD, Residue Method Number RM-22-4) 
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: 
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 established MRLs for fenpropathrin in or on tea, 
green and black at 2.0 ppm. Using the Organization for Economic 
Cooperation and Development (OECD) MRL calculation procedures, the 
recommended U.S. tolerance for tea, dried would be 3.0 ppm. However, 
for the purposes of harmonization of the U.S. tolerance with the 
established Codex MRL, EPA is recommending the tolerance of 2.0 ppm for 
tea, dried. The Agency considers this tolerance level to be adequate 
because the highest field trial value noted for tea, dried was 1.38 
ppm.

C. Revisions to Petitioned-for Tolerances

    Based on the data supporting the petitions, EPA revised the 
proposed tolerances on acerola, feijoa, guava, jaboticaba, 
passionfruit, startfruit and wax jambu from 1.5 ppm to 3.0 ppm; longan, 
lychee, pulasan, rambutan, and Spanish lime from 3.0 ppm to 7.0 ppm; 
and atemoya, birba, cherimoya, custard apple, ilama, soursop, and sugar 
apple, from 1.0 ppm to 1.5 ppm. The Agency revised these tolerance 
levels based on analysis of the residue field trial data using the OECD 
tolerance calculation procedures. EPA also revised the proposed 
commodity definition for tea to tea, dried in order to reflect the 
Agency's commodity nomenclature.
    Finally, the Agency has revised the tolerance expression to clarify 
(1) that, as provided in FFDCA section 408(a)(3), the tolerance covers 
metabolites and degradates of fenpropathrin not specifically mentioned; 
and (2) that compliance with the specified tolerance levels is to be 
determined by measuring only the specific compounds mentioned in the 
tolerance expression.

V. Conclusion

    Therefore, tolerances are established for residues of 
fenpropathrin, alpha-cyano-3-phenoxy-benzyl 2,2,3,3-
tetramethylcyclopropanecarboxylate, in or on acerola, feijoa, guava, 
jaboticaba, passionfruit, starfruit and wax jambu at 3.0 ppm; longan, 
lychee, pulasan, rambutan and Spanish lime, at 7.0 ppm; atemoya, 
biriba, cherimoya, custard apple, ilama, soursop and sugar apple, at 
1.5 ppm; and tea, dried at 2.0 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

[[Page 70908]]

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: November 15, 2012.
Lois Rossi,
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, paragraph (a), revise the introductory text, 
alphabetically add the following commodities and footnote 1 to the 
table to read as follows:

Sec.  180.466  Fenpropathrin; tolerances for residues.

    (a) General. Tolerances are established for residues of 
fenpropathrin, 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 
fenpropathrin (alpha-cyano-3-phenoxy-benzyl 2,2,3,3 
tetramethylcyclopropanecarboxylate).

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
Acerola.................................................             3.0
 
                                * * * * *
Atemoya.................................................             1.5
 
                                * * * * *
Biriba..................................................             1.5
 
                                * * * * *
Cherimoya...............................................             1.5
 
                                * * * * *
Custard apple...........................................             1.5
 
                                * * * * *
Feijoa..................................................             3.0
 
                                * * * * *
Guava...................................................             3.0
 
                                * * * * *
Ilama...................................................             1.5
Jaboticaba..............................................             3.0
 
                                * * * * *
Longan..................................................             7.0
Lychee..................................................             7.0
 
                                * * * * *
Passionfruit............................................             3.0
 
                                * * * * *
Pulasan.................................................             7.0
Rambutan................................................             7.0
 
                                * * * * *
Soursop.................................................             1.5
Spanish lime............................................             7.0
 
                                * * * * *
Starfruit...............................................             3.0
 
                                * * * * *
Sugar apple.............................................             1.5
Tea, dried \1\..........................................             2.0
 
                                * * * * *
Wax jambu...............................................             3.0
------------------------------------------------------------------------
\1\ There are no U.S. registrations as of November 28, 2012, for the use
  of fenpropathrin on tea, dried.

* * * * *
[FR Doc. 2012-28721 Filed 11-27-12; 8:45 am]
BILLING CODE 6560-50-P