Document ID: EPA-HQ-OPP-2010-0472-0008
Agency: epa
Document Type: Rule
Title: Pesticide Tolerances: Zeta Cypermethrin
Posted Date: 2012-12-07T05:00Z

[Federal Register Volume 77, Number 236 (Friday, December 7, 2012)]
[Rules and Regulations]
[Pages 72975-72984]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-29683]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2010-0472; FRL-9371-7]

Zeta Cypermethrin; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of zeta-
cypermethrin 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 December 7, 2012. Objections and 
requests for hearings must be received on or before February 5, 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-2010-0472, 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: Andrew Ertman, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone 
number: (703) 308-9367; email address: ertman.andrew@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://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

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

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an 
objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2010-0472 in the subject line on the first 
page of your submission. All objections and requests for a hearing must 
be in writing, and must be received by the Hearing Clerk on or before 
February 5, 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-2010-0472, 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 issue of August 4, 2010 (75 FR 46924) (FRL-
8834-9), 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 
0E7717) by the IR-4 Project, Rutgers, The State University of New 
Jersey, 500 College Rd. East, Suite 201 W, Princeton, NJ 08540. The 
petition requested that 40 CFR 180.418 be amended by establishing 
tolerances for residues of the insecticide zeta-cypermethrin, in or on 
pistachio at 0.05 parts per million (ppm), artichoke, globe at 0.80 
ppm; barley, grain at 1.7 ppm; barley, hay at 5.0 ppm; barley, straw at 
19.0 ppm; buckwheat, grain at 1.7 ppm; buckwheat, hay at 5.0 ppm; 
buckwheat, straw at 19.0 ppm; oat, grain at 1.7 ppm; oat, hay at 5.0 
ppm; oat, straw at 19.0 ppm; rye, grain at 1.7 ppm; rye, hay at 5.0 
ppm; and rye, straw at 19.0 ppm. That document referenced a summary of 
the petition prepared by FMC, the registrant, which is available in the 
docket, http://www.regulations.gov. A comment was received on the 
notice of filing. EPA's response to this comment is discussed in Unit 
IV.C.
    In the Federal Register issue of February 25, 2011 (76 FR 10584) 
(FRL-8863-3), 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 0E7804) by the IR-4 Project, Rutgers, The State University 
of New Jersey, 500 College Rd. East, Suite 201 W, Princeton, NJ 08540. 
The petition requested that 40 CFR 180.418 be amended by establishing 
tolerances for residues of the insecticide zeta-cypermethrin, (S-
cyano(3-phenoxyphenyl) methyl ())(cis-trans 3-(2,2-
dichloroethenyl)-2,2 dimethylcyclopropanecarboxylate and

[[Page 72976]]

its inactive R-isomers, in or on avocado, black sapote, canistel, mamey 
sapote, mango, papaya, sapodilla, and star apple at 0.45 ppm. That 
document referenced a summary of the petition prepared by FMC, 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 petitions, EPA has 
modified the levels for which tolerances are being established for some 
commodities. The reason for these changes is 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 zeta-cypermethrin including 
exposure resulting from the tolerances established by this action. 
EPA's assessment of exposures and risks associated with zeta-
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.
    The petitions for registration of these new uses of zeta-
cypermethrin rely on zeta-cypermethrin data, as well as previously 
submitted data for the related registered insecticide cypermethrin, and 
the pending new active ingredient alpha-cypermethrin. Alpha-
cypermethrin, cypermethrin, and zeta-cypermethrin are all pyrethroid 
insecticides and are isomer mixtures of the same chemical. Cypermethrin 
consists of a mixture of eight isomers (four diastereoisomeric pairs). 
Zeta-cypermethrin is composed of four of the eight isomers of 
cypermethrin, and also contains one of the isomers in alpha-
cypermethrin. Alpha-cypermethrin consists of two of the four cis-
isomers of cypermethrin.
    Alpha-cypermethrin, cypermethrin, and zeta-cypermethrin 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. These 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.
    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 milligram/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 observed 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 alpha-cypermethrin, 
cypermethrin, and zeta-cypermethrin, 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 was seen in 
offspring animals at the highest dose tested. In the reproduction study 
with 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.
    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 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

[[Page 72977]]

mutagenic activity, was not considered strong enough to warrant a 
linear or no-threshold approach to quantitation of human cancer risk. 
Quantification of risk using a non-linear approach (i.e., acute 
population adjusted dose (aPAD), acute reference dose (aRfD)) will 
adequately account for all chronic toxicity, including carcinogenicity 
that could result from exposure to 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.
    Acute lethality studies conducted with alpha-cypermethrin, 
cypermethrin, and zeta-cypermethrin 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.
    Specific information on the studies received and the nature of the 
adverse effects caused by zeta-cypermethrin as well as the NOAEL and 
the LOAEL from the toxicity studies can be found at http://www.regulations.gov on pp. 60-67 of the document entitled ``Zeta-
Cypermethrin--Human Health Risk Assessment for New Poultry House Use 
and Agricultural Uses on Tropical Fruit, Artichoke, Barley, Oat, Rye, 
Buckwheat, and Pistachio'' in docket ID number EPA-HQ-OPP-2010-0472.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological PODs and levels of concern (LOCs) 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. The PODs are developed based on a careful 
analysis of the doses in each toxicological study to determine the dose 
at which no adverse effects are observed (the NOAEL) and the lowest 
dose at which adverse effects of concern are identified (the LOAEL). 
Uncertainty/safety factors are used in conjunction with the POD to 
calculate a safe exposure level--generally referred to as a population 
adjusted dose (PAD) or a reference dose (RfD)--and a safe margin of 
exposure (MOE). For non-threshold risks, the Agency assumes that any 
amount of exposure will lead to some degree of risk. Thus, the Agency 
estimates risk in terms of the probability of an occurrence of the 
adverse effect expected in a lifetime. For more information on the 
general principles EPA uses in risk characterization and a complete 
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for zeta-cypermethrin used 
for human risk assessment is shown in Table 1 of this unit.

    Table 1--Summary of Toxicological Doses and Endpoints for Zeta-Cypermethrin for Use in Human Health Risk
                                                   Assessment
----------------------------------------------------------------------------------------------------------------
                                        Point of departure and
          Exposure/scenario               uncertainty/safety    RfD, PAD, LOC for  risk  Study and toxicological
                                               factors                 assessment                effects
----------------------------------------------------------------------------------------------------------------
Acute dietary (children >= 6 years     Wolansky BMDL1SD = 7.16  Acute RfD = 0.07 mg/kg/  Wolansky BMD = 11.20 mg/
 old and adults).                       mg/kg.                   day.                     kg based on motor
                                       UFA = 10x..............  aPAD = 0.07 mg/kg/day..   activity.
                                       UFH =10x...............
                                       FQPA SF = 1x...........
----------------------------------------------------------------------------------------------------------------
Acute dietary (children <6 years old)  Wolansky BMDL1SD = 7.16  Acute RfD = 0.07 mg/kg/  Wolansky BMD = 11.20 mg/
                                        mg/kg.                   day.                     kg based on motor
                                       UFA = 10x..............  aPAD = 0.023 mg/kg/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, and therefore the acute dietary endpoint is
                                        protective for chronic exposure
----------------------------------------------------------------------------------------------------------------
Incidental oral short-term (1 to 30    Wolansky BMDL1SD = 7.16  LOC for MOE = 300......  Wolansky BMD = 11.20 mg/
 days).                                 mg/kg.                                            kg based on motor
                                       UFA = 10x..............                            activity.
                                       UFH =10x...............
                                       FQPA SF = 3x...........
----------------------------------------------------------------------------------------------------------------
Inhalation short-term (1 to 30 days)   NOAEL = 0.01 mg/L......  LOC for MOE = 100......  21-Day inhalation study
 (children <6 years old).              HEC = 0.008 mg/L.......                            in the rat. LOAEL =
                                       HED = 1.15 mg/kg/day...                            0.05 mg/L based on
                                       UFA = 3x...............                            increased salivation.
                                       UFH = 10x..............
                                       FQPA SF = 3x...........
----------------------------------------------------------------------------------------------------------------

[[Page 72978]]

 
Inhalation short-term (1 to 30 days)   NOAEL = 0.01 mg/L......  LOC for MOE = 30.......  21-Day inhalation study
 (children >= 6 years old and adults). HEC = 0.008 mg/L.......                            in the rat. LOAEL =
                                       HED = 1.15 mg/kg/day...                            0.05 mg/L based on
                                       UFA = 3x...............                            increased salivation.
                                       UFH = 10x..............
                                       FQPA SF = 1x...........
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation)....  Zeta-cypermethrin has been classified as a possible human carcinogen.
                                        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.
----------------------------------------------------------------------------------------------------------------
1SD = 1 standard deviation. BMD = benchmark dose. BMDL = benchmark dose (lower limit of a 95% confidence
  interval). FQPA SF = Food Quality Protection Act Safety Factor. HEC = human equivalent concentration. HED =
  human equivalent dose. L = Liter. LOAEL = lowest-observed-adverse-effect-level. LOC = level of concern. mg/kg/
  day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-level. PAD =
  population adjusted dose (a = acute). 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).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to zeta-cypermethrin, EPA considered exposure under the 
petitioned-for tolerances as well as all existing zeta-cypermethrin 
tolerances in 40 CFR 180.418. EPA assessed dietary exposures from zeta-
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 zeta-cypermethrin. In estimating 
acute dietary exposure, EPA used food consumption information from the 
United States Department of Agriculture (USDA) 1994-1996 and 1998 
Nationwide Continuing Surveys of Food Intake by Individuals (CSFII). As 
to residue levels in food, EPA conducted a partially refined 
(probabilistic) dietary exposure assessment to determine the exposure 
and risk estimates which result from all the existing uses of 
cypermethrin and zeta-cypermethrin, as well as proposed new uses of 
alpha-cypermethrin and zeta-cypermethrin. Anticipated residues from 
USDA Pesticide Data Program (PDP) monitoring data, field trial data, 
and empirical processing factors were used where appropriate. Percent 
crop treated (PCT) estimates were used for some commodities.
    ii. Chronic exposure. Based on the data summarized in Unit III.A., 
there is no increase in hazard from repeated exposures to zeta-
cypermethrin; 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. EPA determines whether quantitative cancer exposure 
and risk assessments are appropriate for a food-use pesticide based on 
the weight of the evidence from cancer studies and other relevant data. 
Cancer risk is quantified using a linear or non-linear approach. If 
sufficient information on the carcinogenic mode of action is available, 
a threshold or non-linear approach is used and a cancer RfD is 
calculated based on an earlier non-cancer key event. If carcinogenic 
mode of action data are not available, or if the mode of action data 
determines a mutagenic mode of action, a default linear cancer slope 
factor approach is utilized. 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 zeta-
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 
zeta-cypermethrin residues in foods.
    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.
     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 following maximum PCT estimates were used in the acute dietary 
risk assessment for the following crops that are currently registered 
for zeta-cypermethrin/cypermethrin: 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,

[[Page 72979]]

30%; potato, 5%; spinach, 45%; sweet corn, 20%; 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 for the following crops that are currently registered for 
cypermethrin/zeta-cypermethrin: 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%; 
spinach, 30%; sweet corn, 15%; tomato, 5%; and watermelon, 2.5%.
    In most cases, EPA uses available data from the United States 
Department of Agriculture/National Agricultural Statistics Service 
(USDA/NASS), proprietary market surveys, and the National Pesticide Use 
Database for the chemical/crop combination for the most recent 6-7 
years. EPA uses an average PCT for chronic dietary risk analysis. The 
average PCT figure for each existing use is derived by combining 
available public and private market survey data for that use, averaging 
across all observations, and rounding to the nearest 5%, except for 
those situations in which the average PCT is less than one. In those 
cases, 1% is used as the average PCT and 2.5% is used as the maximum 
PCT. EPA uses a maximum PCT for acute dietary risk analysis. The 
maximum PCT figure is the highest observed maximum value reported 
within the recent 6 years of available public and private market survey 
data for the existing use and rounded up to the nearest multiple of 5%.
    The Agency believes that the three conditions discussed in Unit 
III.C.1.iv. have been met. With respect to Condition a, PCT estimates 
are derived from Federal and private market survey data, which are 
reliable and have a valid basis. The Agency is reasonably certain that 
the percentage of the food treated is not likely to be an 
underestimation. As to Conditions b and c, regional consumption 
information and consumption information for significant subpopulations 
is taken into account through EPA's computer-based model for evaluating 
the exposure of significant subpopulations including several regional 
groups. Use of this consumption information in EPA's risk assessment 
process ensures that EPA's exposure estimate does not understate 
exposure for any significant subpopulation group and allows the Agency 
to be reasonably certain that no regional population is exposed to 
residue levels higher than those estimated by the Agency. Other than 
the data available through national food consumption surveys, EPA does 
not have available reliable information on the regional consumption of 
food to which zeta-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 zeta-cypermethrin in drinking water. These simulation 
models take into account data on the physical, chemical, and fate/
transport characteristics of zeta-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 zeta-cypermethrin 
for acute exposures are estimated to be 3.77 parts per billion (ppb) 
for surface water and 0.0036 ppb for ground water. The annual average 
typically used for chronic exposures are estimated to be 0.066 ppb for 
surface water and 0.0036 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 3.77 ppb was used to 
assess the contribution to drinking water. For the purpose of assessing 
short-term aggregate risk (i.e., food, drinking water, and residential 
exposures) the chronic water concentration value of 0.066 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). Cypermethrin and 
zeta-cypermethrin are registered for use on a variety of indoor and 
outdoor residential environments including: Lawns, gardens, pets, and 
indoor surfaces and spaces.
    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. Post-
application inhalation exposure resulting from activities on or around 
previously treated turf is generally not assessed; 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 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.

[[Page 72980]]

     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 one.
    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 zeta-
cypermethrin, share a common mechanism of toxicity. The members of this 
group share the ability to interact with voltage-gated sodium channels, 
ultimately leading to neurotoxicity. The cumulative risk assessment for 
the pyrethroids/pyrethrins was published in the Federal Register issue 
of November 9, 2011 (76 FR 69726) (FRL-8888-9), and is available at 
http://www.regulations.gov in the 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 number 
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 
zeta-cypermethrin will not significantly impact the cumulative 
assessment because, in the cumulative assessment, residential exposure 
was the greatest contributor to the total exposure. As there are no new 
residential uses for the cypermethrins, 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 zeta-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 10-fold (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. 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 studies where body 
weight 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, specifically in the form of 
neurotoxicity. Examination of pharmacokinetic and

[[Page 72981]]

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. EPA is reducing the FQPA SF to 3X for infants and 
children less than 6 years of age. For the general population, 
including children greater than 6 years of age, EPA is reducing the 
FQPA SF to 1X. The decisions regarding the FQPA SFs being used are 
based on the following considerations:
    i. 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 zeta-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 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 alpha-cypermethrin, 
cypermethrin, and zeta-cypermethrin 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 and juvenile sensitivity for pyrethroids, 
including the following:
     Based on an evaluation of over 70 guideline toxicity 
studies for 24 pyrethroids submitted to the Agency, including prenatal 
developmental toxicity studies in rats and rabbits, and pre- and 
postnatal multi-generation reproduction toxicity studies and DNTs in 
rats in support of pyrethroid registrations, there is no evidence that 
pyrethroids directly impact developing fetuses. None of the studies 
show any indications of fetal toxicity at doses that do not cause 
maternal toxicity.
     Increased susceptibility was seen in offspring animals in 
the DNT study with 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 physiologically-based 
pharmacokinetic (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 to 1X 
because there is no evidence in the 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, that pyrethroids directly impact developing 
fetuses. Additionally, none of the studies show any indications of 
fetal toxicity at doses that do not cause maternal toxicity. Because 
there remains some uncertainty as to juvenile sensitivity due to the 
findings in the high-dose LD50 studies, EPA is retaining a 
FQPA SF for infants and children less than 6 years of age. By age 6, 
the metabolic system is expected to be at or near adult levels thus 
reducing concerns for potential age-dependant sensitivity related to 
pharmacokinetics. EPA is seeking additional data to further 
characterize the potential neurotoxicity for pyrethroids. 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:
     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 juvenile sensitivity (i.e., 
sensitivity seen in body weight changes occurred at doses above the 
level chosen for the POD).
     Data showing that the potential sensitivity at high doses 
is likely due to pharmacokinetics.
     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.
     Data indicating that the rat is a conservative model 
compared to the human based on species-specific pharmacodynamics of 
homologous sodium channel isoforms.

[[Page 72982]]

    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 fact that a greater sensitivity to the neurotoxicity of 
pyrethroids is not found in guideline studies following in utero 
exposures (based on 76 studies for 24 pyrethroids) supports this 
conclusion, despite the relatively high doses used in the studies. 
Second, in vitro and in vivo data indicate similar pharmacodynamic 
response to pyrethroids between juvenile and adult rats. Finally, as 
indicated, pharmacokinetic modeling only predicts a 3X difference 
between juveniles and adults. Therefore, the FQPA SF of 3X is 
protective of potential juvenile sensitivity.
    The portion of the uncertainty factor that accounts for potential 
pharmacodynamic differences between animals and rats (i.e., the inter-
species extrapolation factor) are likely to overstate the risk of zeta-
cypermethrin 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 zeta-
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 inter-species factor does not provide extra protection due to 
the conservative nature of their pharmacodynamic components for 
pyrethroids, the 3X additional factor will protect the young.

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, cypermethrin, and zeta-cypermethrin will occupy 
87% of the aPAD for all infants less than 1 year old and children 1-2 
years old, the population groups receiving the greatest exposure.
    2. Chronic risk. Based on the data summarized in Unit III.A., there 
is no increase in hazard with increasing dosing duration. Furthermore, 
chronic dietary exposures will be lower than acute exposures. 
Therefore, the acute aggregate assessment is protective of potential 
chronic aggregate exposures.
    3. Short-term risk. 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 cypermethrin and zeta-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, inhalation, and incidental 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 LOC values for children younger than 6 years old 
were different for oral and inhalation exposure, with an incidental 
oral LOC of 300, and an inhalation LOC of 100. Likewise, the inhalation 
and dietary LOCs for adults were different, with an inhalation LOC of 
30 and a dietary LOC of 100. Therefore, the respective risk estimates 
are combined using the 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 zeta-cypermethrin is acutely toxic and does 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 cypermethrin and zeta-cypermethrin exposure.
    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 alpha-cypermethrin, cypermethrin, and zeta-cypermethrin 
residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate tolerance-enforcement methods are available in ``PAM 
Volume II'' for determining residues of alpha-cypermethrin, 
cypermethrin, and zeta-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 8 stereoisomers), zeta-cypermethrin

[[Page 72983]]

(enriched in 4 isomers) and alpha-cypermethrin (2 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 zeta-cypermethrin, but all are in 
conjunction with MRLs for total cypermethrin isomers (no MRLs have been 
established solely for zeta-cypermethrin). However, although the 
definitions of the covered isomers in the Codex MRLs and U.S. 
tolerances differ formally, they are effectively harmonized since the 
tolerance enforcement methods are not stereo-specific, and thus do not 
distinguish between residues of alpha-cypermethrin, cypermethrin, and 
zeta-cypermethrin. For enforcement purposes, the same moiety is being 
regulated. These tolerances will result in harmonized MRLs between EPA 
and Codex for mango (at 0.7 ppm) and papaya (at 0.5 ppm). The 
tolerances for artichoke, barley, buckwheat, oats, and rye will not be 
harmonized with Codex for the following reasons. In the case of 
artichoke, Codex has set a lower MRL of 0.1 ppm based on field trials 
conducted with alpha-cypermethrin with a different use pattern, 
including a lower use rate and longer pre-harvest interval (PHI). The 
Agency's tolerance for artichoke of 0.6 ppm is supported by the 
submitted residue data, with a higher use rate and shorter PHI. In 
addition, for grains (barley, oats, buckwheat, and rye), the Codex MRLs 
assume a post-harvest treatment whereas the proposed use pattern in the 
United States is for pre-harvest treatment.

C. Response to Comments

    A comment was received that objected to the proposed tolerances 
primarily because of the amounts of pesticides already consumed and 
carried by the American population.
    The Agency understands the commenter's concerns and recognizes that 
some individuals believe that pesticides should be banned completely. 
However, under the existing legal framework provided by FFDCA section 
408, EPA is authorized to establish pesticide tolerances or exemptions 
where persons seeking such tolerances or exemptions have demonstrated 
that the pesticide meets the safety standard imposed by that statute. 
This citizen's comment appears to be directed at the underlying statute 
and not EPA's implementation of it; the citizen has made no contention 
that EPA has acted in violation of the statutory framework.

D. Revisions to Petitioned-for Tolerances

    The Agency has modified the levels for which tolerances are being 
established for artichoke, globe (0.80 to 0.60 ppm); barley, grain (1.7 
to 3.0 ppm); barley, hay (5.0 to 6.0 ppm); barley, straw (19.0 to 20 
ppm); buckwheat, grain (1.7 to 3.0 ppm); buckwheat, hay (5.0 to 6.0 
ppm); buckwheat, straw (19.0 to 20.0 ppm); oat, grain (1.7 to 3.0 ppm); 
oat, hay (5.0 to 6.0 ppm); oat, straw (19.0 to 20.0 ppm); rye, grain 
(1.7 to 3.0 ppm); rye, hay (5.0 to 6.0 ppm); rye, straw (19.0 to 20.0 
ppm); mango (0.45 to 0.70 ppm); and avocado; canistel; papaya; 
sapodilla; sapote, black; sapote, mamey; and star apple (0.45 to 0.50 
ppm). These revisions are due to either EPA's use of the Organization 
for Economic Cooperation and Development (OECD) tolerance calculation 
procedures or to harmonize with Codex MRLs.
    Also, EPA has revised the tolerance expression to clarify:
    1. That, as provided in FFDCA section 408(a)(3), the tolerance 
covers metabolites and degradates of zeta-cypermethrin not specifically 
mentioned.
    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 the 
insecticide, zeta-cypermethrin, (S-cyano(3-phenoxyphenyl) methyl 
())(cis-trans 3-(2,2-dichloroethenyl)-2,2 
dimethylcyclopropanecarboxylate), including its metabolites and 
degradates in or on pistachio at 0.05 ppm; artichoke, globe at 0.60 
ppm; barley, grain at 3.0 ppm; barley, hay at 6.0 ppm; barley, straw at 
20 ppm; buckwheat, grain at 3.0 ppm; buckwheat, hay at 6.0 ppm; 
buckwheat, straw at 20.0 ppm; oat, grain at 3.0 ppm; oat, hay at 6.0 
ppm; oat, straw at 20.0 ppm; rye, grain at 3.0 ppm; rye, hay at 6.0 
ppm; rye, straw at 20.0 ppm; mango at 0.70 ppm; and avocado; canistel; 
papaya; sapodilla; sapote, black; sapote, mamey; and star apple at 0.50 
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

[[Page 72984]]

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 30, 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.  180.418, revise the introductory text of paragraph (a)(2) 
and alphabetically add the following commodities to the table in 
paragraph (a)(2) to read as follows:

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

    (a) * * *
    (2) Tolerances are established for residues of zeta-cypermethrin, 
(S-cyano(3-phenoxyphenyl) methyl ())(cis-trans 3-(2,2-
dichloroethenyl)-2,2 dimethylcyclopropanecarboxylate), including its 
metabolites and degradates, in or on the commodities in the following 
table. Compliance with the tolerance levels specified in the following 
table 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
------------------------------------------------------------------------
 
                                * * * * *
Artichoke, globe..........................................          0.60
Avocado...................................................          0.50
Barley, grain.............................................          3.0
Barley, hay...............................................          6.0
Barley, straw.............................................         20.0
 
                                * * * * *
Buckwheat, grain..........................................          3.0
Buckwheat, hay............................................          6.0
Buckwheat, straw..........................................         20.0
 
                                * * * * *
Canistel..................................................          0.50
 
                                * * * * *
Mango.....................................................          0.70
 
                                * * * * *
Oat, grain................................................          3.0
Oat, hay..................................................          6.0
Oat, straw................................................         20.0
 
                                * * * * *
Papaya....................................................          0.50
 
                                * * * * *
Pistachio.................................................          0.05
 
                                * * * * *
Rye, grain................................................          3.0
Rye, hay..................................................          6.0
Rye, straw................................................         20.0
 
                                * * * * *
Sapodilla.................................................          0.50
Sapote, black.............................................          0.50
Sapote, mamey.............................................          0.50
 
                                * * * * *
Star apple................................................          0.50
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2012-29683 Filed 12-6-12; 8:45 am]
BILLING CODE 6560-50-P