[Federal Register Volume 78, Number 22 (Friday, February 1, 2013)]
[Rules and Regulations]
[Pages 7266-7275]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-02206]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2010-0234; FRL-9376-1]


Alpha-Cypermethrin; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

DATES: This regulation is effective February 1, 2013. Objections and 
requests for hearings must be received on or before April 2, 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-2010-0234, 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: BeWanda Alexander, Registration 
Division (7505P), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-
0001; telephone number: (703) 305-7460; 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://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-2010-0234 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 
April 2, 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-2010-0234, 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 Petition-For Tolerance

    In the Federal Register of May 19, 2010 (75 FR 28009) (FRL-8823-2), 
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 0F7690) 
by BASF Corporation, 26 Davis Drive, P.O. Box 13528, Research Triangle 
Park, NC 27709-3528. The petition requested that 40 CFR 180.418 be 
amended by

[[Page 7267]]

establishing tolerances for residues of the insecticide alpha-
cypermethrin in or on tree nuts, Group 14; dried shelled pea and bean, 
except soybean, subgroup 6C; corn, grain; pop corn; sweet corn; 
soybeans; and sugar beet, roots at 0.05 parts per million (ppm); 
succulent shelled pea and bean, subgroup 6B; and root and tuber 
vegetables, Group 1 at 0.1 ppm; cucurbit vegetables, Group 9; fruiting 
vegetables, Group 8; sugar beet, tops; and wheat, grain at 0.2 ppm; 
citrus fruit, Group 10 at 0.35 ppm; cottonseed; edible podded legume 
vegetable, subgroup 6A; and sorghum, grain at 0.5 ppm; and rice, grain 
at 1.5 ppm; citrus, dried pulp at 1.8 ppm; head and stem Brassica, 
subgroup 5A at 2.0 ppm; citrus, oil at 4.0 ppm; leafy vegetable, except 
Brassica, Group 4 at 10 ppm; and alfalfa, hay at 15 ppm. There were no 
comments received in response to the notice of filing.
    Based upon review of the data supporting the petition, EPA has 
established tolerances for alpha-cypermethrin ((R)-cyano(3-
phenoxyphenyl)methyl (1S,3S)-rel-3-(2,2-dichloroethenyl)-2,2-
dimethylcyclopropane carboxylate) as explained in Unit IV.D.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue. * * 
*''
    Consistent with FFDCA section 408(b)(2)(D), and the factors 
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available 
scientific data and other relevant information in support of this 
action. EPA has sufficient data to assess the hazards of and to make a 
determination on aggregate exposure for alpha-cypermethrin including 
exposure resulting from the tolerances established by this action. 
EPA's assessment of exposures and risks associated with alpha-
cypermethrin 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.
    Alpha-cypermethrin, cypermethrin, and zeta-cypermethrin are all 
pyrethroid insecticides and are isomer mixtures of the same chemical. 
The cypermethrins have been evaluated for a variety of toxic effects in 
experimental toxicity studies. Behavioral changes commonly seen with 
type II pyrethroids were consistently noted in the toxicology database 
for the cypermethrins. These behavioral changes included tremors, gait 
abnormalities, limb conditions, ataxia and hypersensitivity. 
Additionally, body weight changes were routinely observed and mortality 
was seen in a few studies in rats and dogs. Clinical signs were also 
noted in all acute neurotoxicity studies. Decreased activity, gait 
abnormalities, tremors, limb conditions, and hypersensitivity were 
observed at the mid and high doses. Additionally, slight nerve 
degeneration was seen in the acute neurotoxicity study with alpha-
cypermethrin at the high dose. In the subchronic neurotoxicity studies 
with cypermethrin and zeta-cypermethrin, similar behavioral effects 
were seen along with decreased food consumption, body weight, and body 
weight gain.
    Acute toxicology studies conducted with cypermethrins indicate 
moderate acute toxicity via the oral route and low toxicity via the 
acute dermal or inhalation routes. Additionally, mild irritation was 
seen in primary eye and skin irritation studies but no dermal 
sensitization was observed.
    Dermal toxicity studies are available for zeta-cypermethrin (rat) 
and cypermethrin (rabbit), in which local irritation was observed in 
rats and rabbits at the highest doses tested. No systemic effects were 
observed in the 21-day dermal study in the rat conducted with zeta-
cypermethrin at dose levels up to 1,000 milligrams/kilogram/day (mg/kg/
day). In the dermal toxicity study in rabbits with cypermethrin, 
systemic effects were observed (focal necrosis of the liver, decreased 
testicular weights, and decreased body weight in females). However, 
these observations in the rabbit were not used for risk assessment 
because the testing method (i.e., abraded skin) does not simulate 
actual exposure and results in compromised test conditions. 
Additionally, there would be physiological differences between abraded 
and non-abraded animals, further undermining the relevance of these 
results for risk assessment.
    Developmental toxicity and reproduction studies are available for 
the cypermethrins. In the developmental toxicity studies in rats with 
cypermethrin and zeta-cypermethrin, there was no evidence of 
developmental toxicity up to the highest doses tested. Maternal 
toxicity included decreased body weight gain and food consumption in 
both chemicals. Splayed limbs, spasms and hypersensitivity to noise and 
convulsions were seen with cypermethrin, and ataxia, urine-stained 
abdominal fur, and fecal-stained fur were seen with zeta-cypermethrin. 
In the developmental toxicity study in rats with alpha-cypermethrin, 
offspring effects were limited to decreased fetal body weight. Maternal 
effects observations in the study were unsteady gait, piloerection, 
limb splay, and hypersensitivity to sound and touch at the same dose. 
In the developmental toxicity studies in rabbits with the 
cypermethrins, there was no evidence of developmental toxicity up to 
the highest dose tested. Maternal effects seen with cypermethrin 
included decreased body weight gain, anorexia, abdomino-genital 
staining, decreased feces, and red or pink material in the pan. With 
alpha-cypermethrin, maternal effects were body weight loss and 
decreased food consumption. Multi-generation reproduction studies in 
rats are available for cypermethrin and zeta-cypermethrin. In the 
reproduction study with cypermethrin, decreased body weight gain was 
observed in adult animals and decreased body weight gain was seen in 
offspring animals at the highest dose tested. In the reproduction study 
using zeta-cypermethrin, decreased body weight gain and mortality were 
observed in offspring animals in the presence of mortality, increased 
brain weights, decreased body weights, and neurotoxicity in maternal 
animals.
    No effects were observed in an immunotoxicity study in rats with 
alpha-cypermethrin up to the limit dose.
    Alpha-cypermethrin is classified as a Group C ``Possible human 
carcinogen,'' based on an increased incidence of lung adenomas and 
adenomas plus carcinomas combined in females in a mouse carcinogenicity 
study. The

[[Page 7268]]

presence of common benign tumors (lung adenomas), in one species (mice) 
and one sex (female), with no increase in the proportion of malignant 
tumors or decrease in the time-to-tumor occurrence, together with the 
lack of mutagenic activity, was not considered strong enough to warrant 
a quantitative estimation of human risk. Quantification of risk using a 
non-linear approach (i.e., acute population-adjusted dose (aPAD), acute 
reference dose (aRfD)) adequately accounts for all chronic toxicity, 
including carcinogenicity that could result from exposure to alpha-
cypermethrin. While the Agency would typically use a chronic 
population-adjusted dose (cPAD) to protect for cancer concerns, use of 
the aPAD is protective because increasing toxicity with increasing 
duration of exposure is not demonstrated for the cypermethrins. The no-
observed-adverse-effect-level (NOAEL) observed in the mouse cancer 
study in which tumors were observed is 14 mg/kg/day, 2-fold higher than 
the point of departure (POD) used for acute risk assessment. The 
lowest-observed-adverse-effect-level (LOAEL) in the mouse cancer study 
is 57 mg/kg/day based on liver effects, not tumor formation. The tumors 
were seen at 229 mg/kg/day. The acute POD of 7.16 mg/kg/day selected 
for risk assessment is 32-fold lower than the dose that induced lung 
tumors in mice. Only the mouse study with cypermethrin resulted in 
tumor formation, no evidence of carcinogenicity was observed in cancer 
studies in rats with cypermethrin or mice with alpha-cypermethrin.
    Specific information on the studies received and the nature of the 
adverse effects caused by chemical name as well as the NOAEL and the 
LOAEL from the toxicity studies can be found at http://www.regulations.gov in document Human Health Risk Assessment for New 
Active Ingredient--Alpha-cypermethrin at pg. 23 in docket ID number 
EPA-HQ-OPP-2012-0185-0005.

B. Toxicological Points of Departure and Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological POD and levels of concern (LOC) 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 and the lowest dose at which 
adverse effects of concern are identified. Uncertainty/safety factors 
are used in conjunction with the POD to calculate a safe exposure 
level--generally referred to as a PAD or a reference dose (RfD)--and a 
safe margin of exposure (MOE). For non-threshold risks, EPA 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 alpha-cypermethrin 
used for human risk assessment is shown in Table 1 of this unit.

    Table 1--Summary of Toxicological Doses and Endpoints for Alpha-Cypermethrin for Use in Human Health Risk
                                                   Assessment
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                                   POD and uncertainty/   RfD, PAD, LOC for
        Exposure/Scenario             safety factors       risk assessment      Study and toxicological effects
----------------------------------------------------------------------------------------------------------------
Acute dietary (children >=6 years  Wolansky MDL1SD =     aRfD = 0.07 mg/kg/   Wolansky BMD = 11.20 mg/kg/day
 old and adults).                   7.16 mg/kg/day.       day.                 based on motor activity.
                                   UFA = 10x...........  aPAD = 0.07 mg/kg/
                                   UFH = 10x...........   day.
                                   FQPA SF = 1x........
Acute dietary (children <6 years   Wolansky BMDL1SD =    aRfD = 0.07 mg/kg/   Wolansky BMD = 11.20 mg/kg/day
 old).                              7.16 mg/kg/day.       day.                 based on motor activity.
                                   UFA = 10x...........  aPAD = 0.023 mg/kg/
                                   UFH = 10x...........   day.
                                   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, and therefore the acute dietary endpoint is
                                                          protective for chronic exposure.
                                  ------------------------------------------------------------------------------
Incidental oral short-term (1 to   Wolansky BMDL1SD =    LOC for MOE = 300..  Wolansky BMD = 11.20 mg/kg/day
 30 days).                          7.16 mg/kg/day.                            based on motor activity.
                                   UFA = 10x...........
                                   UFH = 10x...........
                                   FQPA SF = 3x........
Inhalation short-term (1 to 30     Inhalation study....  Residential LOC for  21-day inhalation study in the
 days) (children <6 years old).    NOAEL = 0.01 mg/L...   MOE = 100.           rat--LOAEL = .05 mg/L based on
                                   HEC = 0.008 mg/L....                        increased salivation.
                                   HED = 1.15 mg/kg/day
                                   UFA = 3x............
                                   UFH = 10x...........
                                   FQPA SF = 3x........

[[Page 7269]]

 
Inhalation short-term (1 to 30     Inhalation study      LOC for MOE = 30...  21-day inhalation study in the
 days) (children >=6 years old      NOAEL = 0.01 mg/L.                         rat--LOAEL = 0.05 mg/L based on
 and adults) (1 to 6 months).      HEC = 0.008 mg/L....                        increased salvation.
                                   HED = 1.15 mg//kg/
                                    day.
                                   UFA = 3x............
                                   UFH = 10x...........
                                   FQPA SF = 1x........
                                  ------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)       Alpha cypermethrin has been classified as a Group C ``Possible human
                                       carcinogen based on lung adenomas in female mice. 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 cancer dietary exposures.
----------------------------------------------------------------------------------------------------------------

    Point of Departure (POD) = A data point or an estimated point that 
is derived from observed dose-response data and used to mark the 
beginning of extrapolation to determine risk associated with lower 
environmentally relevant human exposures. NOAEL = no observed adverse 
effect level. LOAEL = lowest observed adverse effect level. BMD = 
benchmark dose. BMDL = benchmark dose (lower confidence limit). UF = 
uncertainty factor. UFA = extrapolation from animal to human 
(interspecies). UFH = potential variation in sensitivity among members 
of the human population (intraspecies). FQPA SF = FQPA Safety Factor. 
PAD = population adjusted dose (a = acute, c = chronic). RfD = 
reference dose. MOE = margin of exposure. LOC = level of concern. N/A = 
not applicable. HEC = human equivalent concentration. HED = human 
equivalent dose. Mg/kg/day = milligrams/kilogram/day. Mg/L = 
milligrams/liter.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to alpha-cypermethrin, EPA considered exposure under the 
petitioned-for tolerances as well as all existing cypermethrin and 
zeta-cypermethrin tolerances in 40 CFR 180.418. EPA assessed dietary 
exposures from alpha-cypermethrin 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 alpha-cypermethrin.
    In assessing aggregate risk to alpha-cypermethrin, EPA considered 
not only the exposure associated with the proposed food uses for alpha-
cypermethrin, but also the potential dietary and drinking water 
contribution and residential exposure from existing uses of 
cypermethrin and zeta-cypermethrin. 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 used a partially refined (probabilistic) dietary 
exposure assessment to determine the exposure and risk estimates which 
result from the use of cypermethrins on the crops listed under 40 CFR 
180.418 and the proposed new uses. Anticipated residues from USDA 
Pesticide Data Program (PDP) monitoring data, field trial data, and 
empirical processing factors, and percent crop treated (PCT) estimates 
for some commodities were used where appropriate.
    ii. Chronic exposure. Based on the data summarized in Unit III.A., 
there is no increase in hazard from repeated exposures to alpha-
cypermethrin; the acute dietary exposure assessment is higher than for 
chronic dietary exposures because the acute exposure levels are greater 
than the chronic exposure levels, therefore, a chronic dietary risk 
assessment was not conducted.
    iii. Cancer. As noted in Unit III.A., the Agency has determined 
that quantification of risk using a non-linear approach (i.e., aPAD) 
will adequately account for all chronic toxicity, including 
carcinogenicity, that could result from exposure to alpha-cypermethrin. 
Additionally, because an assessment of cancer risk would estimate 
exposure based on average residue levels and the acute assessment used 
high-end residue levels, the acute dietary assessment will be 
protective of any cancer effects resulting from consumption of alpha-
cypermethrin residues in foods.
    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 demonstrating that the levels in food are 
not above the levels anticipated.
    Section 408(b)(2)(F) of FFDCA states that the Agency may use data 
on the actual percent of food treated for assessing chronic dietary 
risk only if:
     Condition a: The data used are reliable and provide a 
valid basis to show what percentage of the food derived from such crop 
is likely to contain the pesticide residue.
     Condition b: The exposure estimate does not underestimate 
exposure for any significant subpopulation group.
     Condition c: Data are available on pesticide use and food 
consumption in a particular area, the exposure estimate does not 
understate exposure for the population in such area.

[[Page 7270]]

    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 following maximum PCT estimates 
were used in the acute dietary risk assessment, which was relied on in 
assessing chronic risk, for the following crops that are currently 
registered for the cypermethrins: Almonds, 2.5%; apples, 2.5%; 
broccoli, 30%; cabbage, 30%; carrot, 10%; cauliflower, 25%; celery, 
60%; cherries, 5%; grapefruit, 50%; green beans, 20%; green peas, 15%; 
lemon, 2.5%; lettuce, 65%; orange, 45%; peach, 5%; peppers, 30%; 
potato, 5%; sweet corn, 20%; spinach, 45%; tomato, 10%; and watermelon, 
10%.
    The following average PCT estimates were used to calculate average 
dietary exposures in order to assess short-term aggregate risk to the 
cypermethrins: Almonds, 1%; apples, 1%; broccoli, 20%; cabbage, 15%; 
carrot, 2.5%; cauliflower, 15%; celery, 35%; cherries, 5%; grapefruit, 
35%; green beans, 15%; green peas, 10%; lemon, 1%; lettuce, 55%; 
orange, 35%; peach, 2.5%; peppers, 15%; potato, 1%; sweet corn, 15%; 
spinach, 30%; tomato, 5%; and watermelon, 2.5%. The zeta-cypermethrin 
PCT data was used as a surrogate for future PCT of alpha-cypermethrin.
    In most cases, EPA uses available data from the 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 6-7 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 alpha-cypermethrin 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 alpha-cypermethrin in drinking water. These simulation 
models take into account data on the physical, chemical, and fate/
transport characteristics of alpha-cypermethrin. 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 alpha-cypermethrin were 3.77 
parts per billion (ppb) for surface water and 0.0036 ppb for ground 
water. In the dietary risk assessment conducted to support the proposed 
uses, EPA incorporated the surface water EDWCs directly into the 
dietary model, since surface water estimates were higher than those 
provided for ground 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). Alpha-cypermethrin is 
not registered for any specific use patterns that would result in 
residential exposure. There are no proposed residential uses associated 
with alpha-cypermethrin; however, there are registered residential uses 
for cypermethrin and zeta-cypermethrin that have been reassessed to 
reflect updates to the Agency's 2012 Residential standard operating 
procedures (SOPs) along with policy changes for body weight assumptions 
and inhalation rates. These revised residential exposures have been 
incorporated into the human health aggregate risk assessment for alpha-
cypermethrin, which must consider all potential exposures to the 
cypermethrins. The Agency has determined that short-term exposures are 
likely to occur in a residential setting for the cypermethrins; 
however, they do not increase in potency with repeated dosing. EPA 
assessed residential exposure using the following assumptions. The 
quantitative exposure/risk assessment developed for residential 
handlers is based on the following scenarios:
     Mixer/loader/applicator using hose-end sprayer on turf;
     Mixer/loader/applicator using backpack on turf and 
gardens;
     Mixer/loader/applicator using manually pressurized 
handwand for indoor surfaces;
     Application via aerosol can for indoor surfaces and space.
    Since a dermal endpoint was not identified, only a quantitative 
inhalation handler exposure assessment was performed. Residential 
handler inhalation exposure estimates were calculated based on a human 
equivalent concentration and human equivalent dose which reflect 24 
hours of exposure. Since handler exposure is expected to be 
significantly less than 24 hours, the inhalation exposure estimates are 
sufficiently protective of all scenarios (turf, gardens, and indoor 
surface space). Although there is potential inhalation exposure 
resulting from the application of dog tags and spot-on products for 
pets, inhalation exposure is considered negligible for these scenarios 
and therefore a quantitative assessment was not performed for these 
uses.
    There is the potential for post-application exposure for 
individuals as a result of being in an environment that has been 
previously treated with cypermethrin or zeta-cypermethrin. However, the 
combination of low vapor pressure for chemicals typically used as 
active ingredients in outdoor residential pesticide products and 
dilution in outdoor air is likely to result in minimal inhalation 
exposure. Therefore, a quantitative post-application inhalation 
exposure assessment for cypermethrin turf uses was not conducted. Since 
a dermal endpoint was not identified, and indoor post-application 
inhalation exposure resulting from aerosol space sprays, foggers, and 
pet (i.e., dog tag, spot-on) uses is negligible, the only

[[Page 7271]]

potential post-application exposure pathways of concern are incidental 
oral for children, and post-application inhalation exposure for adults 
and children resulting from indoor crack and crevice applications made 
with a manually pressurized handwand. The quantitative exposure/risk 
assessment for residential post-application exposures is based on the 
following scenarios:
     Incidental oral (hand-to-mouth, object-to-mouth, and soil 
ingestion) exposure from turf for children.
     Incidental oral (hand-to-mouth and object-to-mouth) 
exposure from indoor foggers for children.
     Incidental oral (hand-to-mouth and object-to-mouth) 
exposure from pets for children.
     Inhalation exposure for adults and children resulting from 
crack and crevice application to an indoor surface.
     Incidental oral (hand-to-mouth and object-to-mouth) 
exposure for children from indoor surface applications.
    Risk estimates resulting from different exposure routes may be 
combined when it is likely that they can occur simultaneously based on 
the use pattern and when the toxicological effects across different 
routes of exposure are the same. Although, in the case of children, 
inhalation and incidental oral exposure routes share a common 
toxicological endpoint, risk estimates were not combined for those 
routes for turf, indoor fogger, and pet since post-application 
inhalation exposure is considered negligible. However, inhalation and 
incidental oral exposures were combined for post-application risk 
assessment associated with the indoor crack and crevice use. Inhalation 
and incidental oral routes have different LOCs. Therefore, in order to 
combine exposure from the various routes, the aggregate risk index 
(ARI) approach is used to estimate exposure and risk. When this 
approach is used, aggregate risks are not of concern provided the 
calculated ARI is greater than 1.
    The incidental oral scenarios from indoor exposure following crack 
and crevice applications and outdoor exposure from turf were not 
combined, not only because they are not likely to co-occur, but also 
because combining these scenarios would be overly-conservative due to 
the conservative nature of each of the individual assessments.
    Further information regarding EPA standard assumptions and generic 
inputs for residential exposures may be found at http://www.epa.gov/pesticides/trac/science/trac6a05.pdf.
    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 the 
cypermethrins, 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 and pyrethrins was published in the 
Federal Register on November 9, 2011 (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 cypermethrins were included in a recent cumulative risk 
assessment for pyrethrins and pyrethroids. The proposed new uses of 
alpha-cypermethrin will not significantly impact the cumulative 
assessment because, in the cumulative assessment, residential exposure 
was the greatest contributor to the total exposure. There are no new 
residential uses for the cypermethrins, and 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 cypermethrins 
hazard database was selected to derive the POD. Additionally, the POD 
selected for alpha-cypermethrin is specific to the cypermethrins, 
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 (FQPA) Safety Factor (SF). In applying this provision, 
EPA either retains the default value of 10X, or uses a different 
additional safety factor when reliable data available to EPA support 
the choice of a different factor.
    2. Prenatal and postnatal sensitivity. In guideline developmental 
and reproduction studies with the cypermethrins, there was no evidence 
of increased qualitative or quantitative susceptibility in rats or 
rabbits.
    In a guideline developmental neurotoxicity (DNT) study with zeta-
cypermethrin, there was increased sensitivity in the offspring based on 
body weight changes in pups (5%-10%) in the absence of treatment-
related effects in maternal animals. Although, there was a 5%-8% 
decrease in maternal body weight in this study, a body weight decrease 
of <10% is generally not considered adverse in adults, as this is 
considered to be within the range of variability because the magnitude 
of body weight per se is typically small (as an example, a 3 gram (g) 
decrease in body weight from a 338 g rat), and adults are no longer in 
the growth/development phase. In contrast, the offspring are at a stage 
of growth and development and are therefore expected to be gaining 
rather than losing weight. Thus, a smaller percent decrease in body 
weight is considered adverse in the young relative to adults. In the 
case of zeta-cypermethrin, the decrease in body weight of the young is 
comparable to adults; however, it was considered adverse in the young 
but not in the adults. This disparity in interpretation leads to an 
apparent increase in sensitivity in the young; however, concern is 
reduced since the magnitude of body weight decrements was similar in 
adult and young animals. The results from the DNT study are very 
similar to results observed in the reproduction

[[Page 7272]]

studies where body weight (bwt) changes (decreased body weight gain) 
were seen in maternal and offspring animals at doses similar to those 
in the DNT study, with no indication of increased susceptibility. 
Therefore, there is no residual concern for effects observed in the 
study. Additionally, there are well-characterized dose responses, with 
clear NOAELs and LOAELs for effects seen in the DNT and reproduction 
studies, and the endpoints and PODs selected for risk assessment are 
protective.
    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, typically 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) both with regard to inter-species 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.
    3. Conclusion. The FQPA SF was reduced to 1X for the general 
population, women of child bearing age and children > 6 years. For 
exposures from birth to <6 years of age, a 3X FQPA SF was retained 
based on the following considerations:
    i. The toxicology database for the cypermethrins is not complete. 
While the database is considered to be complete with respect to the 
guideline toxicity studies for alpha-cypermethrin, 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 to cypermethrins in 
juvenile rats at high doses, EPA has requested proposals for study 
protocols which could identify and quantify potential juvenile 
sensitivity. However, when evaluated together, the toxicity studies for 
the cypermethrins 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 
neurotoxicity (ACN), subchronic neurotoxicity (SCN), and DNT) in rats, 
and immunotoxicity studies in rats are available. In addition, route-
specific dermal and inhalation studies are available.
    ii. After reviewing the extensive body of data and peer-reviewed 
literature on pyrethroids, the Agency has reached a number of 
conclusions regarding fetal 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 prenatal 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 zeta-cypermethrin (decreased pup body weights) and 
DNT and reproduction studies with beta-cyfluthrin (decreased body 
weights and tremors). However, the reductions in body weight and the 
other non-specific effects occur at 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 PBPK model predicts a 
three-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 with regard to dietary and 
residential exposure. The dietary exposure assessments are based on 
high-end health protective residue levels (that account for parent and 
metabolites of concern), processing factors, and PCT assumptions. 
Furthermore, conservative, upper-bound assumptions were used to 
determine exposure through drinking water and residential sources, such 
that these exposures have not been underestimated.
    Taking all of this information into account, EPA has reduced the 
FQPA SF for women of child-bearing age and children over 6 years to 1X 
since after evaluation of over 70 guideline toxicity studies submitted 
to the Agency, including prenatal developmental toxicity studies in 
rats and rabbits, and multi-generation reproduction toxicity studies 
and DNTs in rats, there is no evidence that pyrethroids directly impact 
developing fetuses. Additionally, none of the studies show any 
indications of fetal/offspring toxicity at doses that do not cause 
maternal toxicity. However, since there remains some uncertainty as to 
juvenile sensitivity due to the findings in the high-dose 
LD50 studies, EPA is retaining a FQPA SF for infants and 
children less than 6 years of age. This age group is a close 
approximation to the most sensitive human population, children from 
birth to <6 years old. EPA is seeking additional data to further 
characterize the potential neurotoxic risk pyrethroid toxicity. 
However, EPA has reliable data that show that reducing the FQPA SF to 
3X will protect the safety of infants and children. These data include:
    (a) data from guideline studies with zeta-cypermethrin at 
relatively high doses that show no sensitivity with regard to 
neurotoxic effects (the most sensitive effect for the pyrethroids) and 
no residual concern regarding overall

[[Page 7273]]

juvenile sensitivity (i.e., sensitivity seen in body weight changes 
occurred at doses above the level chosen for the POD);
    (b) data showing that the potential sensitivity at high doses is 
due to pharmacokinetics alone;
    (c) a rat PBPK model predicting a three-fold increase of pyrethroid 
concentration in juvenile brain compared to adults at high doses due to 
age-dependent pharmacokinetics; and
    (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. First, it is 
likely that the extensive guideline studies with zeta-cypermethrin 
showing no neurotoxicity sensitivity between adults and juveniles 
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 lack of increased neurotoxic sensitivity of the young in 
the overwhelming majority (69 of 70) of the prenatal and postnatal 
guideline studies for pyrethroids supports this conclusion, despite the 
relatively high doses used in those studies. Second, limited in vitro 
and in vivo data indicate similar pharmacodynamic response to 
pyrethroids between juvenile and adult rats. The portion of the 
uncertainty factor that accounts for potential pharmacodynamic 
differences between animals and humans (i.e., the inter-species 
extrapolation factor) is likely to overstate the risk of the 
cypermethrins given the data showing similarities in pharmacodynamics 
between animals and humans. For the inter-species factor, the 
pharmacodynamic portion of the factor is generally considered to be 3X. 
However, for pyrethroids the actual difference is likely to be lower 
than 3X. In addition, there are data that show that there are no 
lifestage pharmacodynamic differences between young and adult rats. 
Standard uncertainty factors, such as those used in the cypermethrin 
risk assessment, assume that there will be such differences. Finally, 
as indicated, pharmacokinetic modeling only predicts a 3X difference 
between juveniles and adults. Thus, even if there is increased juvenile 
neurotoxic sensitivity and even if the existing interspecies and 
intraspecies factors do not provide extra protection due to the 
conservative nature of their pharmacodynamic components for 
pyrethroids, the 3X additional factor will protect the young. 
Therefore, the FQPA factor of 3X is protective of potential juvenile 
sensitivity.

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 
aPAD and 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 alpha-cypermethrin will occupy 87% of the aPAD for all infants (<1 
year old) and children 1-2 years old, the population groups receiving 
the greatest exposure. This assessment is considered to be 
conservative, because tolerance level residues and distributions of 
field trial data (as opposed to monitoring data) were used for many 
commodities. Additionally, although upper-bound estimates were used for 
drinking water, drinking water is not considered to be a major source 
of dietary exposure for the cypermethrins.
    2. Chronic risk. Separate chronic and cancer dietary risk 
assessments were not conducted for the cypermethrins. 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, and therefore the acute dietary endpoint is protective 
for chronic and cancer dietary 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).
    Cypermethrin and zeta-cypermethrin are currently registered for 
uses that could result in short-term residential exposure, and the 
Agency has determined that it is appropriate to aggregate chronic 
exposure through food and water with short-term residential exposures 
to the cypermethrins including alpha-cypermethrin.
    For assessing short-term aggregate risk, the average dietary 
exposure estimate was used since it represents a background exposure 
level from food and drinking water that may co-occur with residential 
exposures. Dietary and oral (hand to mouth) risks for children, and 
dietary and inhalation risks for adults were combined in this 
assessment, since the toxicological endpoints were the same. However, 
the level of concern (LOC) values were different (oral adults and 
children >=6 years old = 100; children <6 years old = 300), while 
inhalation LOC = 30. Therefore, the respective risk estimates are 
combined using the aggregate risk index (ARI) approach. When this 
approach is used, aggregate risks are not of concern provided the 
calculated ARI is greater than 1. The ARI for adults was calculated to 
be 56 and the ARI for children was 2.3. Because these ARIs are greater 
than 1, the risk estimates are not of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level). An intermediate-term aggregate risk assessment was not 
conducted because the cypermethrins are acutely toxic and do not 
increase in potency with repeated dosing. Because the neurotoxicity POD 
used for acute risk assessment is lower (more protective) than PODs for 
longer durations of exposure and acute and short-term exposure levels 
are higher than longer term exposure levels, the acute and short-term 
aggregate assessments are protective for intermediate-term aggregate 
risks anticipated from the cypermethrins.
    5. Aggregate cancer risk for U.S. population. For the reasons 
discussed in Unit III.A. (cancer effects are non-linear and appear at 
higher doses than acute effects) and Unit III.E.2. (chronic exposures 
are lower than acute exposures), the acute aggregate assessment is 
protective of potential cancer risk.
    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 the cypermethrin residues.

[[Page 7274]]

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate tolerance-enforcement methods are available in PAM Volume 
II for determining residues of cypermethrin, zeta-cypermethrin and 
alpha-cypermethrin in plant (Method I) and livestock (Method II) 
commodities. Both methods are gas chromatographic methods with 
electron-capture detection (GC/ECD), and have undergone successful 
Agency petition method validations (PMVs). Method I has a limit of 
detection (LOD) of 0.01 ppm, and Method II has LODs of 0.005 ppm in 
milk, and 0.01 ppm in livestock tissues. These methods are not 
stereospecific; thus no distinction is made between residues of 
cypermethrin (all eight stereoisomers), zeta-cypermethrin (enriched in 
four isomers) and alpha-cypermethrin (two isomers).

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.
    There are multiple Codex MRLs for alpha-cypermethrin, but all are 
in conjunction with MRLs for total cypermethrin isomers (no MRLs have 
been established solely for alpha-cypermethrin). However, although the 
definitions of the isomers covered differ formally between U.S. 
tolerances and Codex MRLs, the definitions of coverage are effectively 
harmonized since the tolerance enforcement methods are not 
stereospecific, and thus do not distinguish between residues of 
cypermethrin, zeta-cypermethrin and alpha-cypermethrin. For enforcement 
purposes, the same moiety is being regulated. As to harmonization of 
tolerance levels, U.S. tolerances and Codex MRLs are identical for tree 
nuts, tomatoes, and cattle meat byproducts. However, the proposed U.S. 
use patterns for all of the other crops for which U.S. tolerances are 
being established differ from the use patterns underlying the Codex 
MRLs associated with these crops. Therefore, these U.S. tolerances 
cannot be established at the same level as the Codex MRLs.

C. Response to Comments

    There were no comments received on this petition.

D. Revisions to Petitioned-For Tolerances

    No revisions to the tolerance levels in the petition, as proposed 
by BASF, were necessary. However, all the proposed commodity 
definitions (except for soybean, seed) were revised to reflect the 
correct commodity definitions, per the Agency's current commodity 
vocabulary. Additionally, appropriate tolerances for alpha-cypermethrin 
in livestock commodities (which were not proposed by BASF) were added 
(reflecting those established for zeta-cypermethrin), based on the 
potential for residues in livestock feed items associated with the 
proposed uses.

V. Conclusion

    Therefore, tolerances are established for residues of alpha-
cypermethrin ((R)-cyano(3-phenoxyphenyl)methyl (1S,3S)-rel-3-(2,2-
dichloroethenyl)-2,2-dimethylcyclopropane carboxylate, in or on cotton, 
undelinted seed, vegetable, legume, edible podded, subgroup 6A, and 
sorghum, grain, grain at 0.50 ppm; vegetable, root and tuber, group 1, 
except sugar beet, pea and bean, succulent shelled, subgroup 6B, and 
hog, fat at 0.10 ppm; nut, tree, group 14-12, pea and bean, dried 
shelled, except soybean, subgroup 6C, corn, field, grain, corn, pop, 
grain, corn, sweet, kernel plus cob with husks removed, soybean, seed, 
beet, sugar, roots, cattle, meat byproducts, egg, goat, meat 
byproducts, hog, meat, horse, meat byproducts, poultry, fat, poultry, 
meat, and sheep, meat byproducts at 0.05 ppm; vegetable, leafy, group 4 
at 10 ppm; Brassica, head and stem, subgroup 5A at 2.0 ppm; rice, grain 
at 1.5 ppm; vegetable, cucurbit, group 9, vegetable, fruiting, group 8-
10, beet, sugar, tops, wheat, grain, cattle, meat, goat, meat, horse, 
meat, and sheep, meat at 0.20 ppm; fruit, citrus, group 10-10 at 0.35 
ppm; citrus, oil at 4.0 ppm; citrus, dried pulp at 1.8 ppm; alfalfa, 
hay at 15 ppm; cattle, fat, goat, fat, horse, fat, sheep, fat at 1.0 
ppm; and milk, fat, reflecting at 0.10 ppm in whole milk at 2.5 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under FFDCA section 408(d) 
in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled ``Regulatory Planning and 
Review'' (58 FR 51735, October 4, 1993). Because this final rule has 
been exempted from review under Executive Order 12866, this final rule 
is not subject to Executive Order 13211, entitled ``Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
``Protection of Children from Environmental Health Risks and Safety 
Risks'' (62 FR 19885, April 23, 1997). This final rule does not contain 
any information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any 
special considerations under Executive Order 12898, entitled ``Federal 
Actions to Address Environmental Justice in Minority Populations and 
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under FFDCA section 408(d), such as the tolerance in this 
final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.), do not apply.
    This final rule directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled ``Federalism'' (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
``Consultation and Coordination with Indian Tribal Governments'' (65 FR 
67249, November 9, 2000) do not apply to this final rule. In addition, 
this final rule does not impose any enforceable duty or contain any 
unfunded mandate

[[Page 7275]]

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: January 23, 2013.
Steven Bradbury,
Director, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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


0
2. In Sec.  180.418 add paragraph (a)(3) to read as follows:


Sec.  180.418  Cypermethrin and an isomer alpha-cypermethrin; 
tolerances for residues.

    (a) * * *
    (3) Tolerances are established for residues of the insecticide, 
alpha-cypermethrin, (R)-cyano(3-phenoxyphenyl)methyl (1S,3S)-rel-3-
(2,2-dichloroethenyl)-2,2-dimethylcyclopropane carboxylate, including 
its metabolites and degradates, in or on the commodities in the table 
below. Compliance with the tolerance levels specified below is to be 
determined by measuring only total cypermethrin, cyano(3-
phenoxyphenyl)methyl 3-(2,2-dichloroethenyl)-2,2-dimethylcyclopropane 
carboxylate, in or on the commodity.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Alfalfa, hay................................................       15
Beet, sugar, roots..........................................        0.05
Beet, sugar, tops...........................................        0.20
Brassica, head and stem, subgroup 5A........................        2.0
Cattle, fat.................................................        1.0
Cattle, meat................................................        0.20
Cattle, meat byproducts.....................................        0.05
Citrus, dried pulp..........................................        1.8
Citrus, oil.................................................        4.0
Corn, field, grain..........................................        0.05
Corn, pop, grain............................................        0.05
Corn, sweet, kernel plus cob with husks removed.............        0.05
Cotton, undelinted seed.....................................        0.50
Egg.........................................................        0.05
Fruit, citrus, group 10-10..................................       10
Goat, fat...................................................        1.0
Goat, meat..................................................        0.20
Goat, meat byproducts.......................................        0.05
Hog, fat....................................................        1.0
Hog, meat...................................................        0.05
Horse, fat..................................................        1.0
Horse, meat.................................................        0.20
Horse, meat byproducts......................................        0.05
Milk, fat, reflecting 0.10 ppm in whole milk................        2.5
Nut, tree, group 14-12......................................        0.05
Pea and bean, dried shelled, except soybean, subgroup 6C....        0.05
Pea and bean, succulent shelled, subgroup 6B................        0.10
Poultry, fat................................................        0.05
Poultry, meat...............................................        0.05
Rice, grain.................................................        1.5
Sheep, fat..................................................        1.0
Sheep, meat.................................................        0.20
Sheep, meat byproducts......................................        0.05
Sorghum, grain, grain.......................................        0.50
Soybean, seed...............................................        0.05
Vegetable, cucurbit, group 9................................        0.20
Vegetable, fruiting, group 8-10.............................        0.20
Vegetable, leafy, group 4...................................       10
Vegetable, legume, edible podded, subgroup 6A...............        0.50
Vegetable, root and tuber, group 1, except sugar beet.......        0.10
Wheat, grain................................................        0.20
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[FR Doc. 2013-02206 Filed 1-31-13; 8:45 am]
BILLING CODE 6560-50-P