[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
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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........
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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.
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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........
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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.
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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
------------------------------------------------------------------------
* * * * *
[FR Doc. 2013-02206 Filed 1-31-13; 8:45 am]
BILLING CODE 6560-50-P