Zeta-Cypermethrin and its Inactive R-isomers; Pesticide Tolerance

Note: EPA no longer updates this information, but it may be useful as a reference or resource.

[Federal Register: February 12, 2002 (Volume 67, Number 29)]
[Rules and Regulations]
[Page 6422-6431]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12fe02-19]

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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-301207; FRL-6818-8]
RIN 2070-AB78

AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for residues ofzeta-
cypermethrin and its inactive R-isomers in or on edible podded legume
vegetables (Crop subgroup 6A) at 0.5 parts per million (ppm);
succulent, shelled peas and beans (Crop subgroup 6B) at 0.1 ppm; dried,
shelled peas and beans, except soybean (Crop subgroup 6C) at 0.05 ppm;
soybean, seed at 0.05 ppm; fruiting vegetables, except cucurbits (Crop
Group 8) at 0.2 ppm; sorghum, grain at 0.5 ppm; sorghum, forage at 0.1
ppm; sorghum, stover at 5.0 ppm; wheat, grain at 0.2 ppm; wheat, forage
at 3.0 ppm; wheat, hay at 6.0 ppm; wheat, straw at 7.0 ppm; aspirated
grain fractions at 10.0 ppm; meat of cattle, goats, hogs, horses, sheep
at 0.2 ppm. FMC Corporation requested this tolerance under the Federal
Food, Drug, and Cosmetic Act, as amended by the Food Quality Protection
Act of 1996. This document also corrects two errors that appeared in
the codified text of a final rule issued for zeta-cypermethrin in the
Federal Register of September 17, 2001. The amendatory language for
that document should have included instructions removing the entry for
milk and adding an entry for goat, fat, under the table in
Sec. 180.418(a)(2). This document corrects those errors.

DATES: This regulation is effective February 12, 2002. Objections and
requests for hearings, identified by docket control number OPP-301207,
must be received by EPA on or before April 15, 2002.

ADDRESSES: Written objections and hearing requests may be submitted by
mail, in person, or by courier. Please follow the detailed instructions
for each method as provided in Unit VI. of the SUPPLEMENTARY
INFORMATION. To ensure proper receipt by EPA, your objections and
hearing requests must identify docket control number OPP-301207 in the
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: George T. LaRocca,
Registration Division (7505C), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460; telephone number: (703) 305-6100; and e-mail
address: larocca.george@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

You may be affected by this action if you are an agricultural
producer, food manufacturer, or pesticide manufacturer. Potentially
affected categories and entities may include, but are not limited to:

------------------------------------------------------------------------
Examples of
Categories NAICS codes potentially
affected entities
------------------------------------------------------------------------
Industry 111 Crop production
112 Animal production
311 Food manufacturing
32532 Pesticide
manufacturing
------------------------------------------------------------------------

This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in the table could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether or not this action might apply to certain entities. If you have
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.

B. How Can I Get Additional Information, Including Copies of this
Document and Other Related Documents?

1. Electronically. You may obtain electronic copies of this
document, and certain other related documents that might be available
electronically, from the EPA Internet Home Page at http://www.epa.gov/.
To access this document, on the Home Page select ``Laws and
Regulations,'' ``Regulations and ProposedRules,'' and then look up the
entry for this document under the ``Federal Register--Environmental
Documents.'' You can also go directly to the Federal Register listings
athttp://www.epa.gov/fedrgstr/. A frequently updated electronic version
of 40 CFR part 180 is available at http://www.access.gpo.gov/nara/cfr/
cfrhtml_00/Title_40/40cfr180_00.html, a beta site currently under
development. To access the OPPTS Harmonized Guidelines referenced in
this document, go directly to the guidelines at http://www.epa.gov/
opptsfrs/home/guidelin.htm.
2. In person. The Agency has established an official record for
this action under docket control number OPP-301207. The official record
consists of the documents specifically referenced in this action, and
other information related to this action, including any information
claimed as Confidential Business Information (CBI). This official
record includes the documents that are physically located in the
docket, as well as the documents that are referenced in those
documents. The public version of the official record does not include
any information claimed as CBI. The public version of the official
record, which includes printed, paper versions of any electronic
comments submitted during an applicable comment period is available for
inspection in the Public Information and Records Integrity Branch
(PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy.,
Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday,

[[Page 6423]]

excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

II. Background and Statutory Findings

In the Federal Register of November 8, 2000 (65 FR 66998) (FRL-
6750-2), EPA issued a notice pursuant to section 408 of the Federal
Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a as amended by the
Food Quality Protection Act of 1996 (FQPA) (Public Law 104-170)
announcing the filing of a pesticide petition (PP) for a tolerance by
FMC Corporation, 1735 Market Street, Philadelphia, PA 19103. This
notice included a summary of the petition prepared by FMC Corporation,
the registrant. There were no comments received in response to the
notice of filing.
The petition requested that 40 CFR 180.418 be amended by
establishing a tolerance for residues of the insecticide zeta-
cypermethrin (-alpha-cyano(3-phenoxyphenyl) methyl (±)(cis-
trans 3-(2,2-dichloroethenyl)-2,2 dimethylcyclopropanecarboxylate in or
onthe following raw agricultural commodities:
PP 0F06207 proposed tolerances in or on the raw agricultural
commodities wheat, grain at 0.15 ppm; wheat forage, at 2.5 ppm; hay at
6.0 ppm; wheat, straw at 6.5 ppm; wheat, bran at 0.20 ppm; sorghum,
grain, at 0.50 ppm; sorghum, forage at 0.10 ppm; sorghum fodder at 1.5
ppm; tomatoes at 0.10 ppm; peppers at 0.30 ppm; peas and beans (dried,
succulent, and edible podded) at 0.50 ppm; soybeans at 0.05 ppm;
poultry, meat at 0.05 ppm; poultry, meat by-products at 0.05 ppm;
poultry, fat at 0.05 ppm; eggs at 0.05 ppm; meat of cattle, goats,
hogs, horses, and sheep at 0.3 ppm; fat of cattle, goats, hogs, horses,
and sheep at 0.30 ppm; and milk, fat at 0.2 ppm (reflecting 0.01 ppm in
whole milk).
Based on EPA's review, the petition was revised by the petitioner
to:Propose tolerances of 0.5 ppm for edible podded legume vegetables
(Crop subgroup 6A); propose tolerances of 0.1 ppm for succulent,
shelled peas and beans (Crop subgroup 6B); propose tolerances of 0.05
ppm in or on dried, shelled peas and beans, except soybean (Crop
subgroup 6C); propose tolerances of 0.05 ppm in or on soybean, seed;
propose tolerances of 0.2 ppm in or on the fruiting vegetables, except
cucurbits group (Crop group 8); propose tolerances of 0.5 ppm in or on
sorghum, grain; propose tolerances of 0.1 ppm in or on sorghum forage;
propose tolerances of 5.0 ppm in or on sorghum, stover; propose
tolerances of 0.2 ppm in or on wheat, grain; propose tolerances of 3.0
ppm in or on wheat, forage; propose tolerances of 6.0 ppm in or on
wheat, hay; propose tolerances of 7.0 ppm in or on wheat straw; propose
tolerances of 10.0 ppm in or on aspirated grain fractions; propose
tolerances of 0.2 ppm in or on meat of cattle, goats, hogs, horses, and
sheep.
Although EPA is requesting a number of changes to the initial
petitions and Notice of Filings, the nature of the changes, i.e.
clarification and correction of commodity terms, international
harmonization of tolerances, reduction in tolerance levels are not
considered significant nor do they alter the risk assessment.
Therefore, EPA is issuing this as a final action.
Section 408(b)(2)(A)(i) of the 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) 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)
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. . . .''
EPA performs a number of analyses to determine the risks from
aggregateexposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 and a complete description of
the risk assessment process, see the final rule on Bifenthrin Pesticide
Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7).

III. Aggregate Risk Assessment and Determination of Safety

Consistent with 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, consistent with section
408(b)(2), for a tolerance for residues of zeta-cypermethrin and its
inactive R-isomers on edible podded legume vegetables (Crop subgroup
6A) at 0.5 ppm; succulent, shelled peas and beans (Crop subgroup 6B) at
0.1 ppm; dried, shelled peas and beans, except soybean (Crop subgroup
6C) at 0.05 ppm; soybean, seed at 0.05 ppm; fruiting vegetables, except
cucurbits (Crop group 8) at 0.2 ppm; sorghum, grain at 0.5 ppm;
sorghum, forage at 0.1 ppm; sorghum, stover at 5.0 ppm; wheat, grain at
0.2 ppm; wheat, forage at 3.0 ppm; wheat, hay at 6.0 ppm; wheat, straw
at 7.0 ppm; aspirated grain fractions at 10.0 ppm; meat of cattle,
goats, hogs, horses, sheep at 0.2 ppm. EPA's assessment of exposures
and risks associated with establishing the tolerances 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 nature of the toxic effects caused by zeta-cypermethrin
and its inactive R-isomers were discussed in detail in the Federal
Register notice of September 17, 2001 (66 FR 47979) (FRL-6801-1). In
that document (Unit III.), the toxicological profile for zeta-
cypermethrin and cypermethrin was fully discussed. The observed health
effects as well as the no observed adverse effect level (NOAEL) and the
lowest observed adverse effect level (LOAEL) were presented in tables
sorted by the EPA Guideline number for each study type. The
presentation of the toxicological profile for zeta-cypermethrin in the
September 17, 2001 Federal Register remains current and can, therefore,
be referenced as background in relation to the tolerances being
established with this document.
Zeta-cypermethrin is an enriched isomer of cypermethrin. In order
to select toxicity endpoints for the purposes of risk assessment,
bridging data on zeta-cypermethrin were submitted so that the toxicity
of zeta-cypermethrin could be compared with that of cypermethrin and
the data bases could be combined to form one complete data base for
both chemicals. In the selection of toxicity endpoints, studies
conducted with zeta-cypermethrin were used wherever possible.

B. Toxicological Endpoints

The dose at which no adverse effects are observed (the NOAEL) from
thetoxicology study identified as appropriate for use in risk
assessment is used to estimate the toxicological level of concern
(LOC). However, the lowest dose at which adverse effects of concern are
identified (the LOAEL) is sometimes

[[Page 6424]]

used for risk assessment if no NOAEL was achieved in the toxicology
study selected. An uncertainty factor (UF) is applied to reflect
uncertainties inherent in the extrapolation from laboratory animal data
to humans and in thevariations in sensitivity among members of the
human population as well as other unknowns. An UF of 100 is routinely
used, 10X to account for interspecies differences and 10X for
intraspecies differences.
For dietary risk assessment (other than cancer) the Agency uses the
UF to calculate an acute or chronic reference dose (acute RfD or
chronic RfD) where the RfD is equal to the NOAEL divided by the
appropriate UF (RfD = NOAEL/UF). Where an additional safety factor is
retained due to concerns unique to the FQPA, this additional factor is
applied to the RfD by dividing the RfD by such additional factor. The
acute or chronic Population Adjusted Dose (aPAD or cPAD) is a
modification of the RfD to accommodate this type of FQPA Safety Factor.
For non-dietary risk assessments (other than cancer) the UF is used
to determine the LOC. For example, when 100 is the appropriate UF (10X
to account for interspecies differences and 10X for intraspecies
differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to
exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated and
compared to the LOC.
The linear default risk methodology (Q*) is the primary method
currently used by the Agency to quantify carcinogenic risk. The Q*
approach assumes that any amount of exposure will lead to some degree
of cancer risk. A Q* is calculated and used to estimate risk which
represents a probability of occurrence of additional cancer cases
(e.g., risk is expressed as 1 x 10-6 or one in a million).
Under certain specific circumstances, MOE calculations will be used for
the carcinogenic risk assessment. In this non-linear approach, a
``point of departure'' is identified below whichcarcinogenic effects
are not expected. The point of departure is typically a NOAEL based on
an endpoint related to cancer effects though it may be a different
value derived from the dose response curve. To estimate risk, a ratio
of the point of departure to exposure (MOE_cancer = point of
departure/exposures) is calculated. A summary of the toxicological
endpoints for zeta-cypermethrin and its inactive R-isomers used for
human risk assessment was presented in Table 3 in Unit III.B. of the
Federal Register of September 17, 2001 (66 FR 47979) (FRL-6801-1). The
selected hazard endpoints used in the risk assessment to support the
tolerances published on September 17, 2001, remain current. Therefore,
the same toxicological dose and hazard endpoints are used in the risk
assessment for the tolerances established through this rulemaking. For
this reason, the detailed table listing the selected endpoints is not
being republished with this final rule. Refer to the September 17, 2001
Federal Register cited above to review the hazard endpoints selected
for zeta-cypermethrin.

C. Exposure Assessment

1. Dietary exposure from food and feed uses. Tolerances have been
established (40 CFR 180.418) for the residues of zeta-cypermethrin and
its inactive R-isomers, in or on a variety of raw agricultural
commodities. Risk assessments were conducted by EPA to assess dietary
exposures from zeta-cypermethrin and its inactive R-isomers in food as
follows:
Zeta-cypermethrin is an enriched-enantiomer verson of the
insecticide cypermethrin. Both cypermethrin and zeta-cypermethrin are
mixtures of eight isomers, with the active components consisting of the
S-enantiomers (``S'' configuration at the cyano bearing carbon). The
two differ in that cypermethrin has a 50:50 R/S ratio whereas zeta-
cypermethrin is enriched in the S-enantiomers with a ratio of 90:10 of
the S/R. The enriched isomer formulation provides for similar insect
control but at lower use rates. Since use of both cypermethrin and
zeta-cypermethrin result in human exposure to the same eight isomers,
dietary and non-dietary (residential) aggregate risk assessment was
conducted by adding the uses of the two chemicals.
i. Acute exposure. Acute dietary 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. The Dietary Exposure Evaluation Model
(DEEMTM) analysis evaluated the individual food consumption
as reported by respondents in the USDA 1989-1992 nationwide Continuing
Surveys of Food Intake by Individuals (CSFII) and accumulated exposure
to the chemical for each commodity. The following assumptions were made
for the acute exposure assessments: Tolerance level residues and 100%
crop treated have been used in these analyses for all commodities
having either established or proposed tolerances of cypermethrin or
zeta-cypermethrin. In cases where a commodity has an established
tolerance for cypermethrin and a proposed tolerance for zeta-
cypermethrin, the larger of the two values was used in the
assessment.DEEM default processing factors were used for all
commodities in this assessment. All exposures are Tier 1 estimates that
are extremely conservative and likely overestimate actual dietary
exposure.

Table 1.--Summary of Acute Dietary Exposure, Dietary Exposure, and Risk for Zeta-Cypermethrin.
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Acute Dietary
Population Subgroup ---------------------------------------------------------------------------------
Dietary Exposure (mg/kg/day) %aPAD
----------------------------------------------------------------------------------------------------------------
U.S. population 0.021818 21.8
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Infants (<1 year old) 0.024398 24.4
----------------------------------------------------------------------------------------------------------------
Children (1-6 years) 0.032668 32.7
----------------------------------------------------------------------------------------------------------------
Females (13-50 years) 0.020468 20.5
----------------------------------------------------------------------------------------------------------------

ii. Chronic exposure. In conducting this chronic dietary risk
assessment the DEEMTM analysis evaluated the individual food
consumption as reported by respondents in the USDA 1989-1992 nationwide
Continuing Surveys of Food Intake by Individuals (CSFII) and
accumulated exposure to the chemical for each commodity. The following
assumptions were made for the chronic exposure assessments: Tolerance-
level residues and 100% crop treated have been used in these analyses
for all commodities having either established or proposed tolerances of

[[Page 6425]]

cypermethrin or zeta-cypermethrin. For chronic risk assessments,
residue estimates for foods (e.g., apples) or food-forms (e.g., apple
juice) of interest are multiplied by the averaged consumption estimate
of each food/food-form of each population subgroup. Exposure estimates
are expressed in mg/kg bwt/day and as a percent of the cPAD.

Table 2.--Summary of Chronic Dietary Exposure and Risk for Zeta-Cypermethrin
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Chronic Dietary
Population Subgroup ---------------------------------------------------------------------------------
Dietary Exposures (mg/kg/day) %cPAD
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U.S. population 0.007442 2.4
----------------------------------------------------------------------------------------------------------------
Infants (<1 year old) 0.006485 10.8
----------------------------------------------------------------------------------------------------------------
Children (1-6 years) 0.014017 23.4
----------------------------------------------------------------------------------------------------------------
Females (13-50 years) 0.006513 10.9
----------------------------------------------------------------------------------------------------------------

As shown by the summarized acute and chronic results in Tables 1
and 2, all risk estimates fall below EPA's level of concern
(³ 100% PAD). All exposures are Tier 1 estimates that are
extremely conservative and likely overestimate actual dietary exposure.
Refinements to the analyses in the form of percent crop treated
considerations and/or anticipated residues would likely reduce the
exposure and risk estimates for zeta-cypermethrin.
iii. Cancer. Cypermethrin has been classified as a Category C,
possible human carcinogen, based on an increased incidence of lung
adenomas and adenomas plus carcinomas combined in female mice (Cancer
Peer Review Committee, 1988). The evidence was not considered strong
enough to warrant a quantitative estimation of human risk. Cypermethrin
has not been classified under the more current, Proposed Guidelines for
Carcinogen Risk Assessment (April 10, 1996). Because zeta-cypermethrin
is an enriched isomer of cypermethrin, it is also classified as a
Category C carcinogen and a RfD approach was recommended for human risk
assessment purposes.
2. Dietary exposure from drinking water. Based on the available
data, cypermethrin/zeta-cypermethrin is a moderately persistent
chemical that primarily degrades by photolysis in water and
biodegradation. Depending on the environmental circumstances, it may
persist for periods of months post-treatment. Cypermethrin is tightly
bound to soil particles and is not likely to move to ground waters.
However, the degradate dichlorovinyl acid (DCVA) is mobile and likely
to reach ground waters. Additional information about the mobility of
this degradate has been requested. Cypermethrin can contaminate surface
waters through spray drift. Under some conditions it may also have a
potential for runoff into surface waters (primarily through erosion),
for several months post-application. Since zeta-cypermethrin is
preferentially associated to the soils, the fraction of the chemical in
the water column should be small. In addition, it is expected that
treatment of drinking water would remove substantial portions of
cypermethrin/zeta-cypermethrin present in water. Although the Agency
has not addressed residues of DCVA in water, the Agency has concluded
that DCVA does not need to be included in the dietary risk for food.
The Agency uses the First Index Reservoir Screening Tool (FIRST) or
thePesticide Root Zone/Exposure Analysis Modeling System (PRZM/EXAMS),
to produceestimates of pesticide concentrations in an index reservoir.
The SCI-GROW model is used to predict pesticide concentrations in
shallow ground water. For a screening-level assessment for surface
water, EPA will use FIRST (a tier 1 model) before using PRZM/EXAMS (a
tier 2 model). The FIRST model is a subset of the PRZM/EXAMS model that
uses a specific high-end runoff scenario for pesticides. While both
FIRST and PRZM/EXAMS incorporate an index reservoir environment, the
PRZM/EXAMS model includes a percent crop area factor as an adjustment
to account for the maximum percent crop coverage within a watershed or
drainage basin.
None of these models include consideration of the impact processing
(mixing, dilution, or treatment) of raw water for distribution as
drinking water would likely have on the removal of pesticides from the
source water. The primary use of these models by the Agency at this
stage is to provide a coarse screen for sorting out pesticides for
which it is highly unlikely that drinking water concentrations would
ever exceed human health levels of concern.
Since the models used are considered to be screening tools in the
risk assessment process, the Agency does not use estimated
environmental concentrations (EECs) from these models to quantify
drinking water exposure and risk as a %RfD or %PAD. Instead drinking
water levels of comparison (DWLOCs) are calculated and used as a point
of comparison against the model estimates of a pesticide's
concentration in water. DWLOCs are theoretical upper limits on a
pesticide's concentration in drinking water in light of total aggregate
exposure to a pesticide in food, and from residential uses. Since
DWLOCs address total aggregate exposure to zeta-cypermethrin and its
inactive R-isomers, they are further discussed in the aggregate risk
sections below.
Based on the FIRST and SCI-GROW models, the EECs of zeta-
cypermethrin and its inactive R-isomers for acute exposures are
estimated to be 8.9 parts per billion (ppb) for surface water and 0.006
ppb for ground water. The EECs for chronic exposures are estimated to
be 0.46 ppb for surface water and 0.006 ppb for ground water. These
values generally represent upper-bound estimates of the concentrations
that might be found in surface water and ground water due to the use of
cypermethrin on Brassica vegetables, which has the highest application
rate among both cypermethrin and zeta-cypermethrin on all crops over
which the chemicals are applied.
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).
Zeta-cypermethrin and its inactive R-isomers is not registered for
use on any sites that would result in residential exposure. However,
cypermethrin does have indoor and outdoor residential uses (zeta-
cypermethrin is an enriched-enantiomer version of the insecticide

[[Page 6426]]

cypermethrin). The analytical method does not distinguish cypermethrin
from zeta-cypermethrin, and the toxicological endpoints are the same.
Therefore, dietary and non-dietary residential aggregate risk
assessment is conducted by adding the uses of the two chemicals.
4. Cumulative exposure to substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) 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.''
EPA does not have, at this time, available data to determine
whether zeta-cypermethrin and its inactive R-isomers has a common
mechanism of toxicity with other substances or how to include this
pesticide in a cumulative risk assessment. Unlike other pesticides for
which EPA has followed a cumulative risk approach based on a common
mechanism of toxicity, zeta-cypermethrin and its inactive R-isomers
does not appear to produce a toxic metabolite produced by other
substances. For the purposes of this tolerance action, therefore, EPA
has not assumed that zeta-cypermethrin and its inactive R-isomers has a
common mechanism of toxicity with other substances. For information
regarding EPA's efforts to determine which chemicals have a common
mechanism of toxicity and to evaluate the cumulative effects of such
chemicals, see the final rule for Bifenthrin Pesticide Tolerances (62
FR 62961, November 26, 1997).

D. Safety Factor for Infants and Children

1. In general. FFDCA section 408 provides that EPA shall apply an
additional tenfold 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 data base on toxicity and exposure
unless EPA determines that a different margin of safety will be safe
for infants and children. Margins of safety are incorporated into EPA
risk assessments either directly through use of a margin of exposure
(MOE) analysis or through using uncertainty (safety) factors in
calculating a dose level that poses no appreciable risk to humans.
2. Prenatal and postnatal sensitivity. The data demonstrated no
indication of increased sensitivity of rats or rabbits to in utero and
or postnatal exposure to either zeta-cypermethrin or cypermethrin. In
the prenatal developmental toxicity studies in rats, there was no
evidence of developmental toxicity at the highest does tested (35 mg/
kg/day). Maternal toxicity (decreased body weight gain (both
chemicals), and food consumption, ataxia, urine and feces-stained for
(zeta-cypermethrin) was observed at the LOAEL of 25 mg/kg/day. The
maternal NOAELs were established at 12.5 mg/kg/day for zeta-
cypermethrin and 17.5 mg/kg/day for cypermethrin. In the definitive
rabbit developmental toxicity study conducted with cypermethrin, the
maternal LOAEL was 450 mg/kg/day based on decreased body weight gain.
No developmental toxicity was observed at dose levels up to 700 mg/kg/
day. In the 2-generation reproduction study in rats conducted with
zeta-cypermethrin, off-spring toxicity (decreased pup weight gain
during lactation) was observed at the same treatment level which
resulted in parental systemic toxicity (NOAEL: 27 mg/kg/day; LOAEL: 45
mg/kg/day). In the definitive multigeneration reproduction study
conducted with cypermethrin, the parental NOAEL/LOAEL is lower than the
pup NOAEL/LOAEL, both based on decreased in body weight gain (2.5/7.5
mg/kg/day for the parents versus 7.5/37.5 mg/kg/day for the pups).
3. Conclusion. There is a complete toxicity data base forzeta-
cypermethrin and its inactive R-isomers and exposure data are complete
or are estimated based on data that reasonably accounts for potential
exposures. The safety factor can be removed for zeta-cypermethrin and
its inactive R-isomers because: (1) There is no indication of
quantitative or qualitative increased susceptibility of rats or rabbits
to in utero and/or postnatal exposure; (2) the requirement of a
developmental neurotoxicity study is not based on criteria reflecting
special concern for the developing fetuses or young which are generally
used for requiring a developmental neurotoxicity study - and a safety
factor (e.g., neuropathy in adult animals; central nervous system
malformation following prenatal exposure; brain weight or sexual
maturation changes in offspring; and/or functional changes in
offspring) and therefore does not warrant an FQPA safety factor; and
(3) the dietary (food and drinking water) and non-dietary exposure
assessment will not underestimate the potential exposures for infants
and children.

E. Aggregate Risks and Determination of Safety

To estimate total aggregate exposure to a pesticide from food,
drinking water, and residential uses, the Agency calculates DWLOCs
which are used as a point of comparison against the model estimates of
a pesticide's concentration in water (EECs). DWLOC values are not
regulatory standards for drinking water. DWLOCs are theoretical upper
limits on a pesticide's concentration in drinking water in light of
total aggregate exposure to a pesticide in food andresidential uses. In
calculating a DWLOC, the Agency determines how much of the acceptable
exposure (i.e., the PAD) is available for exposure through drinking
water e.g., allowable chronic water exposure (mg/kg/day) = cPAD -
(average food + residential exposure). This allowable exposure through
drinking water is used to calculate a DWLOC.
A DWLOC will vary depending on the toxic endpoint, drinking water
consumption, and body weights. Default body weights and consumption
values as used by the USEPA Office of Water are used to calculate
DWLOCs: 2L/70 kg (adult male), 2L/60 kg (adult female), and 1L/10 kg
(child). Default body weights and drinking water consumption values
vary on an individual basis. This variation will be taken into account
in more refined screening-level and quantitative drinking water
exposure assessments. Different populations will have different DWLOCs.
Generally, a DWLOC is calculated for each type of risk assessment used:
Acute, short-term, intermediate-term, chronic, and cancer.
When EECs for surface water and ground water are less than the
calculated DWLOCs, EPA concludes with reasonable certainty that
exposures to the pesticide in drinking water (when considered along
with other sources of exposure for which EPA has reliable data) would
not result in unacceptable levels of aggregate human health risk at
this time. Because EPA considers the aggregate risk resulting from
multiple exposure pathways associated with a pesticide's uses, levels
of comparison in drinking water may vary as those uses change. If new
uses are added in the future, EPA will reassess the potential impacts
of residues of the pesticide in drinking water as a part of the
aggregate risk assessment process.
1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food to zeta-
cypermethrin and its inactive R-isomers will occupy 22% of the aPAD for
the U.S. population, 21% of the aPAD for females 13 years and older,
24% of the aPAD for infants (>1 year old), and 33% of the aPAD for
children (1-6 years). In addition, there is potential for acute
dietaryexposure to zeta-cypermethrin and its inactive R-isomers in
drinking water. After calculating DWLOCs and

[[Page 6427]]

comparing them to the EECs for surface and ground water, EPA does not
expect the aggregate exposure to exceed 100% of the aPAD, as shown in
the following Table 3:

Table 3.--Aggregate Risk Assessment for Acute Exposure to zeta-cypermethrin and its inactive R-isomers

----------------------------------------------------------------------------------------------------------------
Surface Ground
Population Subgroup aPAD (mg/ %aPAD Water EEC Water EEC Acute DWLOC
kg) (Food) (ppb)1 (ppb)1 (ppb)2
----------------------------------------------------------------------------------------------------------------
U.S. population 0.10 22% 8.9 0.006 2,700
----------------------------------------------------------------------------------------------------------------
All infants (< 1 year old) 0.10 24% 8.9 0.006 760
----------------------------------------------------------------------------------------------------------------
Children (1-6 years old) 0.10 33% 8.9 0.006 670
----------------------------------------------------------------------------------------------------------------
Females (13-50 years old) 0.10 21% 8.9 0.006 2,400
----------------------------------------------------------------------------------------------------------------
1 EECs resulting from the maximum proposed application rate (Cypermethrin on brassica vegetables).
2 The acute DWLOC was calculated as follows: DWLOC (µg/L) = maximum water exposure (mg/kg/day) x body
weight (kg) consumption (L/day) x 0.001 mg/µg

2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to zeta-
cypermethrin and its inactive R-isomers from food will utilize 12% of
the cPAD for the U.S. population, 11% of the cPAD for infants (<1 year
old) and 23% of the cPAD for children (1-6 years). There are no
residential uses for zeta-cypermethrin and its inactive R-isomers that
result in chronic residential exposure to zeta-cypermethrin and its
inactive R-isomers. However, cypermethrin does have indoor and outdoor
residential uses (zeta-cypermethrin is an enriched-enantiomer version
of the insecticide cypermethrin). The analytical method does not
distinguish cypermethrin from zeta-cypermethrin, and the toxicological
endpoints are the same. Therefore, dietary and non-dietary residential
aggregate risk assessment is conducted by adding the use of the two
chemicals. Based on the use pattern, chronic residential exposure to
residues of zeta-cypermethrin and its inactive R-isomers is not
expected. In addition, there is potential for chronic dietary exposure
to zeta-cypermethrin and its inactive R-isomers in drinking water.
After calculating DWLOCs and comparing them to the EECs for surface and
ground water, EPA does not expect the aggregate exposure to exceed 100%
of the cPAD, as shown in the following Table 4:

Table 4.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to zeta-cypermethrin and its inactive R-
isomers

----------------------------------------------------------------------------------------------------------------
Surface Ground
Population Subgroup cPAD mg/kg/ %cPAD Water EEC Water EEC Chronic
day (Food) (ppb) (ppb) DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. population 0.06 12 0.46 0.006 1,900
----------------------------------------------------------------------------------------------------------------
All infants (<1year old) 0.06 11 0.46 0.006 540
----------------------------------------------------------------------------------------------------------------
Children (1-6years old) 0.06 23 0.46 0.006 460
----------------------------------------------------------------------------------------------------------------
Females 13-50 years old 0.06 11 0.46 0.006 1,600
----------------------------------------------------------------------------------------------------------------

3. Short-term risk. Short-term aggregate exposure takes into
account residential exposure plus chronic exposure to food and water
(considered to be a background exposure level).
Zeta-cypermethrin and its inactive R-isomers is not registered for
use on any sites that would result in residential exposure; however,
cypermethrin does have indoor and outdoor residential uses (zeta-
cypermethrin is an enriched-enantiomer version of the insecticide
cypermethrin). Cypermethrin registered residential uses constitute
short- and intermediate-term exposure scenarios; endpoints have been
selected for short- and intermediate-term incidental oral and
inhalation exposures, and the acceptable MOEs for short- and
intermediate-term exposures are 100. Since the toxicological effects
through the inhalation exposure route are similar to those
toxicological effects through the oral routes, short-term aggregate
risk assessment was conducted adding inhalation, oral non-dietary
exposure, and average food and water exposure.
Since all the acceptable MOEs are at the same level, the aggregate
risks for population subgroup can be estimated by calculating aggregate
Margin of Exposure values (MOE_aggregate).
MOE_aggregate = 1/MOE_I + 1/MOE_D + 1/
MOE_O +1/MOE_food + 1/MOE_water where
I = inhalation, D = dermal (no dermal endpoints were selected), O =
non-dietary oral, MOE_food = average food from the chronic
DEEM analysis.
As residue values in water from monitoring data are not available,
therefore, as with the acute dietary aggregate risk estimate for the
short- and intermediate-term aggregate risk assessments, the DWLOCs
have to be back calculated. Using the exposure assumptions described in
this unit for short-term exposures, EPA has concluded that food and
residential exposures aggregated result in aggregate MOEs of 1,500 for
adult males, 1,700 for

[[Page 6428]]

adult females, 830 for a child, and 1,700 for infants. These aggregate
MOEs do not exceed the Agency's level of concern for aggregate exposure
to food and residential uses. In addition, short-term DWLOCs were
calculated and compared to the EECs for chronic exposure of zeta-
cypermethrin and its inactive R-isomers in ground and surface water.
After calculating DWLOCs and comparing them to the EECs for surface and
ground water, EPA does not expect short-term aggregate exposure to
exceed the Agency's level of concern, as shown in the following Table
5:

Table 5.--Aggregate Risk Assessment for Short-Term Exposure to zeta-cypermethrin and its inactive R-isomers

----------------------------------------------------------------------------------------------------------------
Aggregate Surface Ground Water
Aggregate Level of Water EEC EEC (µ Short-Term
Population Subgroup MOE (Food + Concern (µg/ g/L) DWLOC (µ
Residential) (LOC) L) g/L)
----------------------------------------------------------------------------------------------------------------
Adult male 1,300 100 0.46 0.006 3,300
----------------------------------------------------------------------------------------------------------------
Adult female 1,500 100 0.46 0.006 2,800
----------------------------------------------------------------------------------------------------------------
Child 600 100 0.46 0.006 830
----------------------------------------------------------------------------------------------------------------
Infants 1,000 100 0.46 0.006 910
----------------------------------------------------------------------------------------------------------------

4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).
Zeta-cypermethrin and its inactive R-isomers is not registered for
use on any sites that would result in residential exposure; however,
cypermethrin does have indoor and outdoor residential uses (zeta-
cypermethrin is an enriched-enantiomer version of the insecticide
cypermethrin). Cypermethrin registered residential uses constitute
short- and intermediate-term exposure scenarios; endpoints have been
selected for short- and intermediate-term incidental oral and
inhalation exposures, and the acceptable MOEs for short- and
intermediate-term exposures are 100. Since the toxicological effects
through the inhalation exposure route are similar to those
toxicological effects through the oral routes, short-term aggregate
risk assessment was conducted adding inhalation, oral non-dietary
exposure, and average food and water exposure.
Since all the acceptable MOEs are at the same level, the aggregate
risks for the population subgroups can be estimated by calculating
aggregate Margin of Exposure values (MOE _aggregate).
MOE_aggregate = 1/MOE_I + 1/MOE_D + 1/
MOE_O + 1/MOE_food+1/MOE_water.
Using the exposure assumptions described in this unit for
intermediate-term exposures, EPA has concluded that food and
residential exposures aggregated result in aggregate MOEs of 640 for
adult males, 740 for adult females, 300 for child, and 530 for infants.
These aggregate MOEs do not exceed the Agency's level of concern for
aggregate exposure to food and residential uses. In addition,
intermediate-term DWLOCs were calculated and compared to the EECs for
chronic exposure of zeta-cypermethrin and its inactive R-isomers in
ground and surface water. After calculating DWLOCs and comparing them
to the EECs for surface and ground water, EPA does not expect
intermediate-term aggregate exposure to exceed the Agency's level of
concern, as shown in the following Table 6:

Table 6.--Aggregate Risk Assessment for Intermediate- Term Exposure to zeta-cypermethrin and its inactive R-isomers

--------------------------------------------------------------------------------------------------------------------------------------------------------
Aggregate MOE Intermediate-Term
Population Subgroup (Food + Aggregate Level Surface Water EEC Ground Water EEC DWLOC µg/
Residential) of Concern (LOC) µg/L µg/L L
--------------------------------------------------------------------------------------------------------------------------------------------------------
Adult male 640 100 0.46 0.006 1,500
--------------------------------------------------------------------------------------------------------------------------------------------------------
Adult female 740 100 0.46 0.006 1,300
--------------------------------------------------------------------------------------------------------------------------------------------------------
Child 300 100 0.46 0.006 330
--------------------------------------------------------------------------------------------------------------------------------------------------------
Infant 530 100 0.46 0.006 410
--------------------------------------------------------------------------------------------------------------------------------------------------------

5. Aggregate cancer risk for U.S. population. Cypermethrin/zeta-
cypermethrin has been classified as a Category C carcinogen, based on
an increased incidence of lung adenomas and adenomas plus carcinomas
combined in female mice. However, the evidence was not considered
strong enough to warrant a quantitative estimation of human risk. An
RfD approach was recommended for human risk assessment purposes.
Dietary risk concerns due to long-term consumption of zeta-cypermethrin
are adequately addressed in the chronic exposure analysis. For the U.S.
population only 11% of RfD is occupied by chronic food and water
exposure.
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

[[Page 6429]]

population, and to infants and children from aggregate exposure to
zeta-cypermethrin and its inactive R-isomers residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

Adequate enforcement methods are available for determination of
cypermethrin residues in plants and animal products in PAM II (Method
1). This method involves initial acetone-hexane extraction, followed by
partitioning with water. The organic layer is evaporated, then
redissolved in cyclohexane-methylene chloride and passed through a gel
permeation column. The eluate is evaporated, redissolved in hexane and
passed through a Florisil column. Cypermethrin residues are analyzed by
gas chromatography (GC) with an electron capture detector (ECD). Since
zeta-cypermethrin is an isomer enriched form of cypermethrin and the
zeta-cypermethrin is an enriched form of cypermethrin, and the PAM II
method is not stereospecific, this method is considered adequate for
enforcement of the proposed tolerances of zeta-cypermethrin.

B. International Residue Limits

There are no specific Codex maximum residue limits (MRLs) for zeta-
cypermethrin, but there are Codex MRLs for cypermethrin. The proposed
or recommended U.S. tolerances for residue zeta-cypermethrin in/on
soybean seeds (0.05 ppm), eggs (0.05 ppm), dried shelled peas and beans
(0.05 ppm), and meat byproducts (0.05 ppm) are equivalent to their
respective Codex MRLs. The recommended U.S. tolerance for fruiting
vegetables (0.2 ppm) is also equivalent to the Codex MRL for egg
plants, but is lower than Codex MRLs for tomatoes and peppers (0.5 mg/
kg). Recommended U.S. tolerances for meat (cattle, goats, hogs, horses,
and sheep) and sorghum stover will be increased to 0.2 and 5.0 ppm,
respectively to match their equivalent Codex MRLs. The recommended U.S.
tolerances for milk and wheat hay and straw are higher than their
equivalent Codex MRLs and cannot be harmonized. The recommended U.S
tolerance for succulent shelled peas and beans cannot be harmonized
with the Codex MRLs for common beans and peas since the crop groups are
defined differently. The Codex definitions are based on the crop being
a pea or a bean, whereas the U.S. groups are based on whether the raw
agricultural commodity is shelled or the pod is consumed.

V. Conclusion

Therefore, the tolerance is established for residues of zeta-
cypermethrin and its inactive R-isomers, Z-cypermethrin (S-cyano (3-
phenoxyphenyl) methyl (+/-) (cis-trans 3-(2,2-dichloro, in or on edible
podded legume vegetables (Crop subgroup 6A) at 0.5 ppm; succulent,
shelled peas and beans (Crop subgroup 6B) at 0.1 ppm; dried, shelled
peas and beans, except soybean (Crop subgroup 6C) at 0.05 ppm; soybean,
seed at 0.05 ppm; fruiting vegetables, except cucurbits (Crop group 8)
at 0.2 ppm; sorghum, grain at 0.5 ppm; sorghum, forage at 0.1 ppm;
sorghum, stover at 5.0 ppm; wheat, grain at 0.2 ppm; wheat, forage at
3.0 ppm; wheat, hay at 6.0 ppm; wheat, straw at 7.0 ppm; aspirated
grain fractions at 10.0 ppm; meat of cattle, goats, hogs, horses, sheep
at 0.2 ppm.

VI. Objections and Hearing Requests

Under section 408(g) of the FFDCA, as amended by the FQPA, any
person may file an objection to any aspect of this regulation and may
also request a hearing on those objections. The EPA procedural
regulations which govern the submission of objections and requests for
hearings appear in 40 CFR part 178. Although the procedures in those
regulations require some modification to reflect the amendments made to
the FFDCA by the FQPA of 1996, EPA will continue to use those
procedures, with appropriate adjustments, until the necessary
modifications can be made. The new section 408(g) provides essentially
the same process for persons to ``object'' to a regulation for an
exemption from the requirement of a tolerance issued by EPA under new
section 408(d), as was provided in the old FFDCA sections 408 and 409.
However, the period for filing objections is now 60 days, rather than
30 days.

A. What Do I Need to Do to File an Objection or Request a Hearing?

You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in this unit
and in 40 CFR part 178. To ensure proper receipt by EPA, you must
identify docket control number OPP-301207 in the subject line on the
first page of your submission. All requests must be in writing, and
must be mailed or delivered to the Hearing Clerk on or before April 15,
2002.
1. Filing the request. Your objection must specify the specific
provisions in the regulation that you object to, and the grounds for
the objections (40 CFR 178.25). If a hearing is requested, the
objections must include a statement of the factual issues(s) on which a
hearing is requested, the requestor's contentions on such issues, and a
summary of any evidence relied upon by the objector (40 CFR 178.27).
Information submitted in connection with an objection or hearing
request may be claimed confidential by marking any part or all of that
information as CBI. Information so marked will not be disclosed except
in accordance with procedures set forth in 40 CFR part 2. A copy of the
information that does not contain CBI must be submitted for inclusion
in the public record. Information not marked confidential may be
disclosed publicly by EPA without prior notice.
Mail your written request to: Office of the Hearing Clerk (1900),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460. You may also deliver your request to the Office
of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St., SW.,
Washington, DC 20460. The Office of the Hearing Clerk is open from 8
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the Office of the Hearing Clerk is (202) 260-4865.
2. Tolerance fee payment. If you file an objection or request a
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must
mail the fee to: EPA Headquarters Accounting Operations Branch, Office
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please
identify the fee submission by labeling it ``Tolerance Petition Fees.''
EPA is authorized to waive any fee requirement ``when in the
judgement of the Administrator such a waiver or refund is equitable and
not contrary to the purpose of this subsection.'' For additional
information regarding the waiver of these fees, you may contact James
Tompkins by phone at (703) 305-5697, by e-mail at tompkins.jim@epa.gov,
or by mailing a request for information to Mr. Tompkins at Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
If you would like to request a waiver of the tolerance objection
fees, you must mail your request for such a waiver to: James Hollins,
Information Resources and Services Division (7502C), Office of
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460.
3. Copies for the Docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit VI.A., you
should also send a copy of your request to the PIRIB for its

[[Page 6430]]

inclusion in the official record that is described in Unit I.B.2. Mail
your copies, identified by docket control number OPP-301207, to: Public
Information and Records Integrity Branch, Information Resources and
Services Division (7502C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
In person or by courier, bring a copy to the location of the PIRIB
described in Unit I.B.2. You may also send an electronic copy of your
request via e-mail to: opp-docket@epa.gov. Please use an ASCII file
format and avoid the use of special characters and any form of
encryption. Copies of electronic objections and hearing requests will
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format.
Do not include any CBI in your electronic copy. You may also submit an
electronic copy of your request at many Federal Depository Libraries.

B. When Will the Agency Grant a Request for a Hearing?

A request for a hearing will be granted if the Administrator
determines that the material submitted shows the following: There is a
genuine and substantial issue of fact; there is a reasonable
possibility that available evidence identified by the requestor would,
if established resolve one or more of such issues in favor of the
requestor, taking into account uncontested claims or facts to the
contrary; and resolution of the factual issues(s) in the manner sought
by the requestor would be adequate to justify the action requested (40
CFR 178.32).

VII. Regulatory Assessment Requirements

This final rule establishes a tolerance 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 rule has been
exempted from review under Executive Order 12866 due to its lack of
significance, this rule is not subject to Executive Order 13211,
Actions Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May 22, 2001). 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., or impose
any enforceable duty or contain any unfunded mandate as described under
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law
104-4). 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); or OMB review or any Agency action under Executive
Order 13045, entitled Protection of Children from Environmental Health
Risks and Safety Risks (62 FR 19885, April 23, 1997). 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), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). 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. In addition, the Agency has determined that this
action will not have a substantial direct effect on States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government, as specified in Executive Order 13132, entitled Federalism
(64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to
develop an accountable process to ensure ``meaningful and timely input
by State and local officials in the development of regulatory policies
that have federalism implications.'' ``Policies that have federalism
implications'' is defined in the Executive Order to include regulations
that have ``substantial direct effects on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government.'' This final rule directly regulates growers, food
processors, food handlers and food retailers, not States. This action
does not alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). For these same reasons, the Agency has
determined that this rule does not have any ``tribal implications'' as
described in Executive Order 13175, entitled Consultation and
Coordination with Indian Tribal Governments (65 FR 67249, November 6,
2000). Executive Order 13175, requires EPA to develop an accountable
process to ensure ``meaningful and timely input by tribal officials in
the development of regulatory policies that have tribal implications.''
``Policies that have tribal implications'' is defined in the Executive
Order to include regulations that have ``substantial direct effects on
one or more Indian tribes, on the relationship between the Federal
government and the Indian tribes, or on the distribution of power and
responsibilities between the Federal government and Indian tribes.''
This rule will not have substantial direct effects on tribal
governments, on the relationship between the Federal government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal government and Indian tribes, as specified in
Executive Order 13175. Thus, Executive Order 13175 does not apply to
this rule.

VIII. Submission to Congress and the Comptroller General

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. 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 this final rule in the Federal Register. This final
rule 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, 2002.
Peter Caulkins,
Acting Director, Registration Division, Office of Pesticide Programs.

Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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

2. Section 180.418 is amended by removing the entire entries for
``hogs, meat'' and ``milk''; alphabetically adding 15 commodities; and
revising

[[Page 6431]]

the entries for ``cattle, meat,'' ``goat, meat'' ``horse, meat,'' and
``sheep, meat,'' in the table in paragraph (a)(2) to read as follows:

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

(a) * * *
(2) * * *

------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
* * * * *
Aspirated grain fractions...................... 10.0 ppm
* * * * *
Cattle, meat................................... 0.2 ppm
* * * * *
Dried, shelled peas and beans, except soybean 0.05 ppm
(Crop subgroup 6C)............................
Edible podded legume vegetables (Crop subgroup 0.5 ppm
6A)...........................................
* * * * *
Fruiting vegetables, except cucurbits (Crop 0.2 ppm
Group 8)......................................
Goat, fat...................................... 1.00 ppm
* * * * *
Goat, meat..................................... 0.2 ppm
* * * * *
Hog, meat...................................... 0.2 ppm
* * * * *
Horse, meat.................................... 0.2 ppm
* * * * *
Sheep, meat.................................... 0.2 ppm
Sorghum, forage................................ 0.1 ppm
Sorghum, grain................................. 0.5 ppm
Sorghum, stover................................ 5.0 ppm
Soybean, seed.................................. 0.05 ppm
Succulent, shelled peas and beans (Crop 0.1 ppm
subgroup 6B)..................................
* * * * *
Wheat, forage.................................. 3.0 ppm
Wheat, grain................................... 0.2 ppm
Wheat, hay..................................... 6.0 ppm
Wheat straw.................................... 7.0 ppm
------------------------------------------------------------------------

* * * * *

[FR Doc. 02-2611 Filed 2-11-02; 8:45 am]
BILLING CODE 6560-50-S

Zeta-Cypermethrin and its Inactive R-isomers; Pesticide Tolerance

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