[Federal Register Volume 69, Number 68 (Thursday, April 8, 2004)]
[Rules and Regulations]
[Pages 18480-18489]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-7979]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2004-0025; FRL-7353-4]
Lambda-Cyhalothrin and an Isomer Gamma-Cyhalothrin; Tolerances
for Residues
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: EPA is amending 40 CFR part 180 by promulgating a new
tolerance expression for the isomer form of gamma-cyhalothrin. Gamma-
cyhalothrin is the isolated active isomer of lambda-cyhalothrin under
40 CFR 180.438. Pytech Chemicals GmbH, 9330 Zionsville Rd.,
Indianapolis, IN 46268, requested this change in tolerance expression
in support of the registration of a pesticide formulation enriched with
the gamma isomer of lambda-cyhalothrin.
DATES: This regulation is effective April 8, 2004. Objections and
requests for hearings, identified by docket ID number OPP-2004-0025,
must be received on or before June 7, 2004.
ADDRESSES: Written objections and hearing requests may be submitted
electronically, by mail, or through hand delivery/courier. Follow the
detailed instructions as provided in Unit VI. of the SUPPLEMENTARY
INFORMATION.
FOR FURTHER INFORMATION CONTACT: William G. Sproat, Jr.,Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW.,Washington, DC 20460-
0001; telephone number: (703) 308-8587; e-mail 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.
Potentially affected entities may include, but are not limited to:
Crop production (NAICS 111), e.g., agricultural
workers; greenhouse,
[[Page 18481]]
nursery, and floriculture workers; farmers.
Animal production (NAICS 112), e.g., cattle
ranchers and farmers, dairy cattle farmers, livestock farmers.
Food manufacturing (NAICS 311), e.g.,
agricultural workers; farmers; greenhouse, nursery, and floriculture
workers; ranchers; pesticide applicators.
Pesticide manufacturing (NAICS 32532), e.g.,
agricultural workers; commercial applicators; farmers; greenhouse,
nursery, and floriculture workers; residential users.
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 this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
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 Copies of this Document and Other Related Information?
1. Docket. EPA has established an official public docket for this
action under docket identification (ID) number OPP-2004-0025. The
official public docket consists of the documents specifically
referenced in this action, any public comments received, and other
information related to this action. Although a part of the official
docket, the public docket does not include Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute. The official public docket is the collection of materials
that is available for public viewing at the Public Information and
Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall 2,
1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open
from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal
holidays. The docket telephone number is (703) 305-5805.
2. Electronic access. You may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr/. A frequently updated
electronic version of 40 CFR part 180 is available at E-CFR Beta Site
Two at http://www.gpoaccess.gov/ecfr/.
An electronic version of the public docket is available through
EPA's electronic public docket and comment system, EPA Dockets. You may
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public
comments, access the index listing of the contents of the official
public docket, and to access those documents in the public docket that
are available electronically. Although not all docket materials may be
available electronically, you may still access any of the publicly
available docket materials through the docket facility identified in
Unit I.B.1. Once in the system, select ``search,'' then key in the
appropriate docket ID number.
II. Background and Statutory Findings
In the Federal Register of February 25, 2004 (69 FR 8654)(FRL-7345-
5), EPA issued a notice pursuant to section 408(d)(3) of the Federal
Food, Drug, and Comestic Act (FFDCA), 21 U.S.C. 346a(d)(3), announcing
the filing of a pesticide petition (PP 4F6812) by Pytech Chemicals
GmbH, 9330 Zionsville Rd., Indianapolis, IN 46268. That notice included
a summary of the petition prepared by Pytech Chemicals GmbH, the
registrant. There were no comments received in response to the notice
of filing.
The petition requested that 40 CFR 180.438 be amended by adding
gamma-cyhalothrin, ((S)-a-cyano-3-phenoxybenzyl (Z)-(1R,3R)-3-(2-
chloro-3,3,3- trifluoripropenyl)-2,2-dimethylcyclopropanecarboxylate)
to the tolerance expression of lambda-cyhalothrin, ((S)-alpha-cyano-3-
phenoxybenzyl-(Z)-(1R,3R)-3-(2-chloro-3,3,3-trifluoroprop-1-enyl)-2,1-
dimethylcyclopropanecarboxylate and (R)-alpha-cyano-3-phenoxybenzyl-
(Z)-(1S,3S)-3-(2-chloro-3,3,3-trifluoroprop-1-enyl)-2, 2-
dimethylcyclopropanecarboxylate). Gamma-cyhalothrin is a single,
resolved isomer of the pyrethroid insecticide cyhalothrin, and as such
shares physical, chemical, and biological properties with both
cyhalothrin and lambda-cyhalothrin, which are mixtures of 4 and 2
isomers respectively. Gamma-cyhalothrin is the most insecticidally
active isomer of cyhalothrin/lambda-cyhalothrin, and thus the technical
gamma-cyhalothrin product may be considered a refined form of
cyhalothrin/lambda-cyhalothrin in that it has been purified by removal
of less active and inactive isomers. Thus, similar levels of
insecticidal efficacy for gamma-cyhalothrin can be obtained with
significantly reduced application rates as compared with either
cyhalothrin or lambda-cyhalothrin.
The tolerance under 40 CFR 180.438 currently identifies lambda-
cyhalothrin as a 1:1 mixture of two isomers and their epimers, one of
which is the gamma isomer. The gamma isomer is present at 42% in this
mixture. By contrast in the proposed tolerance expression the gamma
isomer is present at 98% in the mixture. The petitioner requested this
change in tolerance expression to support the registration of a
pesticide formulation enriched with the gamma isomer of lambda-
cyhalothrin.
EPA is also moving the dried hop cone food additive tolerance under
40 CFR 180.438(a)(3) to the table under 40 CFR 180.438(a)(1) since the
Agency no longer establishes tolerances for pesticide residues under
section 409 of FFDCA. The remainder of 40 CFR 180.438(a)(3) is being
removed.
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. . .
.''
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 of FFDCA 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) of FFDCA, 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) of FFDCA. Aggregate risk assessment and determination of
safety is discussed in this rule and the final rule on Lambda-
cyhalothrin Tolerances (67 FR 60902, September 27, 2002) (FRL-7200-1).
[[Page 18482]]
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 toxicological evaluation of gamma-cyhalothrin can be
accomplished by studies with gamma-cyhalothrin itself as well as by
studies on lambda-cyhalothrin and/or cyhalothrin (the unpurified isomer
compounds). Cyhalothrin and lambda-cyhalothrin have been reviewed by
EPA for toxicity endpoint selection for the various exposure scenarios.
Because gamma-cyhalothrin is a component of the other two mixed-isomer
compounds, gamma-cyhalothrin essentially has been evaluated in the
previous toxicological studies with cyhalothrin and lambda-cyhalothrin.
The nature of the toxic effects caused by lambda-cyhalothrin as well as
the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-
adverse-effect-level (LOAEL) from the toxicity studies reviewed are
discussed in detail in the Federal Register of September 27, 2002 (67
FR 60902) (FRL-7200-1). The toxicological profile for cyhalothrin in
the September 27, 2002 Federal Register remains current and can
therefore be referenced as background information in support of this
action.
Gamma-cyhalothrin is a single resolved isomer of cyhalothrin. In
order to select toxicity endpoints for the purposes of risk assessment,
bridging data on gamma-cyhalothrin were submitted so that the toxicity
of gamma cyhalothrin could be compared with that of cyhalothrin 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 gamma-cyhalothrin were used whenever possible. The nature of the
toxic effects of the data on gamma- cyhalothrin are discussed in Table
1 of this unit as well as the NOAEL and the LOAEL from the toxicity
studies reviewed.
Table 1.--Subchronic, Chronic, and Other Toxicity
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Guideline No. Study Type Results
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870.1200 21-Day Dermal Toxicity - NOAEL: 100 mg/kg/day
Rabbit LOAEL: 1,000 mg/kg/day (significant
Cyhalothrin................ weight loss)
Lambda cyhalothrin......... None
Gamma cyhalothrin..........
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870.3100 13-Week Dietary -Rat - NOAEL: 2.5 mg/kg/day
Cyhalothrin................ LOAEL: 12.5 mg/kg/day (decreased body
weight gain in males).
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870.3100 13-Week Dietary - Rat NOAEL: 2.5 mg/kg/day
Lambda cyhalothrin......... LOAEL: 12.5 mg/kg/day (reduced body
weight gain and food consumption in
both sexes and food efficiency in
females).
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870.3100 13-Week Dietary - Rat NOAEL: male/female =3.4/4.2 mg/kg/day
Gamma cyhalothrin.......... LOAEL: male/female = 6.6/8.8 mg/kg/day
(mortality in males, neuromuscular
effects in both sexes, dermatitis, and
gross and microscopic skin lesions in
females).
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870.3150 26-Week Dietary - Dog NOAEL: 1.0 mg/kg/day
Cyhalothrin................ LOAEL: 2.5 mg/kg/day (increase in
Lambda cyhalothrin......... liquid feces. At 10.0 mg/kg/day,
Gamma cyhalothrin.......... clinical signs of neurotoxicity).
None
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None 4-Week Dietary - Mouse NOAEL: 64.2/77.9 mg/kg/day
Cyhalothrin................ LOAEL: 309/294 mg/kg/day (mortality,
Lambda cyhalothrin......... clinical signs of toxicity, decreases
Gamma cyhalothrin.......... in body weight gain and food
consumption. changes in hematology and
organ weights, minimal cetrilobular
hepatocyte enlargement).
None
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None Chronic Toxicity - Dog NOAEL: 0.1 mg/kg/day
Lambda cyhalothrin......... LOAEL: 0.5 mg/kg/day (clinical signs of
Cyhalothrin................ neurotoxicity). Note: For one or two
Gamma cyhalothrin.......... days of dosing, the NOEL is 0.5 mg/kg.
None
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870.3200 21-Day Dermal Toxicity - Rat NOAEL: 10 mg/kg/day
Lambda cyhalothrin......... LOAEL: 50 mg/kg/day (clinical signs of
Cyhalothrin................ toxicity, decreased body weight and
Gamma cyhalothrin.......... body weight gain)
None
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870.3200 28-Day Dietary - Rat NOAEL: 2 mg/kg/day
Cyhalothrin................ LOAEL: 10 mg/kg/day (clinical signs of
neurotoxicity). At higher doses,
decreases in body weight gain and food
consumption and changes in organ
weights
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870.3200 28-Day Dietary - Rat NOAEL: 1.0 mg/kg/day
Cyhalothrin................ LOAEL: 2.0 mg/kg/day (decreases in mean
Lambda cyhalothrin......... body weight gain in females).
None
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[[Page 18483]]
870.3200 Gamma cyhalothrin NOAEL: male/female = 4.2/4.5 mg/kg/day
LOAEL: male/female = 8.8/10.2 mg/kg/
day. (decreased body weight, body
weight gain, food consumption,
clinical and biochemical effects).
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870.3200 Gamma cyhalothrin Maternal NOAEL: 0.5 mg/kg/day
Maternal LOAEL: 2.0 mg/kg/day (clinical
signs, reduced body weight and body
weight gain and food consumption).
Developmental NOAEL: 2.0 mg/kg/day
Developmental LOAEL: Not established
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870.3465 21-Day Inhalation Toxicity - NOAEL: 0.08 mg/kg/day
Rat LOAEL: 0.90 mg/kg/day (clinical signs
Lambda cyhalothrin......... of neurotoxicity, decreased body
Cyhalothrin................ weight gains, increased incidence of
Gamma cyhalothrin.......... punctate foci in cornea, slight
reductions in cholesterol in females,
slight changes in selected urinalysis
parameters).
None
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870.3700 Developmental Toxicity - Rat Maternal NOAEL: 10 mg/kg/day
Cyhalothrin................ Maternal LOAEL: 15 mg/kg/day
Lambda cyhalothrin......... (uncoordinated limbs, reduced body
weight gain and food consumption).
Developmental NOAEL: 15 mg/kg/day
Developmental LOAEL: Not established
None
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870.3700 Developmental Toxicity - Maternal NOAEL: 10 mg/kg/day
Rabbit Maternal LOAEL: 30mg/kg/day (reduced
Cyhalothrin................ body weight gain and food
Lambda cyhalothrin......... consumption).
Gamma cyhalothrin.......... Developmental NOAEL: 30 mg/kg/day
Developmental LOAEL: Not established
None
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870.3800 3-Generation Reproduction - Parental NOAEL: 1.5 mg/kg/day
Rat Parental LOAEL: 5.0 mg/kg/day
Cyhalothrin................ (decreased parental body weight and
Lambda cyhalothrin......... body weight gain during premating and
Gamma cyhalothrin.......... gestation periods).
Reproductive NOAEL: 5.0 mg/kg/day
Reproductive LOAEL: Not established.
Offspring NOAEL: 1.5 mg/kg/day
Offspring LOAEL: 1.5 mg/kg/day (reduced
pup weight and weight gain during
lactation).
None
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870.4100 Chronic Toxicity/ NOAEL: 2.5 mg/kg/day
Carcinogenicity - Rat LOAEL: 12.5 mg/kg/day (decreases in
Cyhalothrin................ mean body weight)
Lambda cyhalothrin......... No evidence of carcinogenicity.
Gamma cyhalothrin.......... None
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870.4200 Carcinogenicity - Mouse NOAEL: 15 mg/kg/day
Cyhalothrin................ LOAEL: 75 mg/kg/day (increased
Lambda cyhalothrin......... incidence of piloerection, hunched
Gamma cyhalothrin.......... posture; decreased body weight gain in
males).
No evidence of carcinogenicity.
None
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870.6200 Sub Neurotoxicity - Rat NOAEL: 11.4 mg/kg/day
Lambda cyhalothrin......... LOAEL: Not Established
Cyhalothrin................ None
Gamma cyhalothrin..........
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870.7485 Metabolism and In the rat, approximately 55% of the
Pharmacokinetics oral dose is absorbed. It is
Lambda cyhalothrin......... extensively metabolized when absorbed.
Cyhalothrin................ After subcutaneous administration, the
urinary/fecal excretion ration is
2.5:1.0. Over 50% of the dose remained
in the carcass 7 days after a
subcutaneous dose. Metabolism includes
cleavage of the ester to
cyclopropylcarboxylic acid and a
phenoxybenzyl derivative. The
distribution patterns and excretion
rate in the multiple oral dose studies
are similar to the single oral dose
studies. There is accumulation of
unchanged compound in the fat upon
chronic administration. Otherwise,
cyhalothrin is rapidly metabolized and
excreted. Cyclopropyl carboxylic 3-4'-
hydroxyphenoxy benzoic acid and a
sulfate conjugate were identified in
the urine. Cyhalothrin is taken up
slowly by the fat andreleased slowly.
It is rapidly released by blood,
kidney, liver.
----------------------------------------------------------------------------------------------------------------
These data indicate that bridging to the single resolved isomer is
possible and endpoints for risk assessment may be from the gamma isomer
toxicity data itself or in accordance with the Agency's ``Draft Policy
for Determining Toxicology Data Requirements for Enriched Isomer
Technical Products'' (Revised April 1999) which states that
[[Page 18484]]
once we determine that the data can be bridged, toxicity endpoints can
conservatively be estimated by assigning all toxic effects seen in the
isomer mixture to the resolved isomer (in this case gamma-cyhalothrin).
It is noted that in the developmental toxicity study in the rat
that the resolved gamma isomer is over an order of magnitude more toxic
than in cyhalothrin. Since there were no effects on the fetus in either
study and these studies are not used for toxicity endpoint selection,
the impact of this difference is marginal.
B. Toxicological Endpoints
The dose at which the NOAEL from the toxicology study identified as
appropriate for use in risk assessment is used to estimate the
toxicological level of concern (LOC). However, the LOAEL of concern
identified is sometimes 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 the variations 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.
Three other types of safety or UFs may be used: ``Traditional
UFs;'' the ``special FQPA safety factor;'' and the ``default FQPA
safety factor.'' By the term ``traditional UFs,'' EPA is referring to
those additional UFs used prior to FQPA passage to account for database
deficiencies. These traditional UFs have been incorporated by the FQPA
into the additional safety factor for the protection of infants and
children. The term ``special FQPA safety factor'' refers to those
safety factors that are deemed necessary for the protection of infants
and children primarily as a result of the FQPA. The ``default FQPA
safety factor'' is the additional 10X safety factor that is mandated by
the statute unless it is decided that there are reliable data to choose
a different additional factor (potentially a traditional UF or a
special FQPA safety factor).
For dietary risk assessment (other than cancer) the Agency uses the
UF to calculate an acute or chronic reference dose (aRfD or cRfD) where
the RfD is equal to the NOAEL divided by an UF of 100 to account for
interspecies and intraspecies differences and any traditional UFs
deemed appropriate (RfD = NOAEL/UF). Where a special FQPA safety factor
or the default FQPA safety factor is used, 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 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). An example of how such a probability risk is expressed
would be to describe the risk as one in one hundred thousand (1 X
10-\5\), one in a million (1 X 10-\6\), or one in
ten million (1 X 10-\7\). 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 which carcinogenic 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 (MOEcancer = point of departure/exposures) is
calculated.
A summary of the toxicological endpoints for gamma cyhalothrin used
for human risk assessment is shown in Table 2 of this unit. The
toxicity studies submitted and reviewed were a battery of acute
toxicity studies, 90-day feeding study in the rat, a developmental
toxicity study in the rat, and a battery of mutagenicity studies. These
studies taken together with those for cyhalothrin and lamba-cyhalothrin
(i.e. a combination of studies) were used for hazard assessment of
gamma-cyhalothrin for human health risk assessment.
Table 2.--Summary of Toxicological Dose and Endpoints for Gamma-Cyhalothrin for Use in Human Risk Assessment
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Special FQPA SF* and
Exposure Scenario Dose Used in Risk Level of Concern for Study and Toxicological
Assessment, UF Risk Assessment Effects
----------------------------------------------------------------------------------------------------------------
Acute dietary general population Dose = 0.25 FQPA SF = 1 X Chronic oral study in
including UF = 100............... aPAD acute RfD......... the dog (lambda-
(infants and children)............... Acute RfD = 0.0025 FQPA SF = 0.0025 mg/kg/ cyhalothrin)
milligrams(mg)/ day. Clinical signs of
kilograms (kg). neurotoxicity (ataxia)
observed from day 2, 3
to 7 hours post-
dosing.
----------------------------------------------------------------------------------------------------------------
Chronic dietary NOAEL = 0.1 FQPA SF = 1 X Chronic oral study in
(all populations).................... UF = 100............... cPAD = chronic RfD..... the dog (lambda-
Chronic RfD = 0.001 mg/ FQPA SF = 0.001 mg/kg/ cyhalothrin)
kg/day. day. Gait abnormalities
observed in two dogs.
----------------------------------------------------------------------------------------------------------------
Short-term NOAEL = 0.1 mg/kg/day Residential LOC for MOE Chronic oral study in
Incidental oral (1-30 days).......... = 100 the dog (lambda-
Intermediate-term.................... Occupational = NA...... cyhalothrin)
Incidental 0ral (1-6 months)......... Gait abnormalities
observed in two dogs.
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[[Page 18485]]
Short-term dermal (1 to 30 days) Dermal dose a = 5.0 mg/ Residential LOC for MOE 21-Day dermal toxicity
Long-term dermal (< 6 months)........ kg/day = 100 study in the rat
Occupational LOC for (lambda- cyhalothrin)
MOE = 100. Clinical signs of
neurotoxicity
(observed from day 2)
and decreased body
weight and body weight
gain.
----------------------------------------------------------------------------------------------------------------
Short-term inhalation Inhalation dose a = Residential LOC for MOE 21-Day inhalation study
(1 to 30 days)....................... 0.04 mg/kg/day = 100 in rats (lambda-
Intermediate-term dermal (1 to 6 Occupational LOC for cyhalothrin)
months). MOE = 100. Clinical signs of
Long-term dermal (< 6 months)........ neurotoxicity, and
systemic toxicity.
----------------------------------------------------------------------------------------------------------------
Cancer Classified as ``Not likely to be Carcinogenic to Humans''
(oral, dermal, inhalation)...........
----------------------------------------------------------------------------------------------------------------
Dosea = The values indicated above for acute dietary, dermal and inhalation exposure scenarios are the adjusted
NOAELs (multiplied by a factor of 1/89/21/13/23/85/83/8 based on the purity of the lambda isomer
compared to the enriched isomer gamma-cyhalothrin. This was not done for the chronic effect dose in the dog
study since it was determined by the OPPTS Hazard Identification Assessment review Committee that the NOAEL
was very conservative and based on marginal effects at the LOEL of 0.5 mg/kg/day.
UF = uncertainty factor, FQPA SF = special FQPA safety factor, NOAEL = no-observed-adverse-effect-level, LOAEL =
lowest-observed-adverse-effect-level, PAD = population adjusted dose (a = acute, c = chronic) RfD = reference
dose, MOE = margin of exposure, LOC = level of concern.
C. Exposure Assessment
Tolerances are established under 40 CFR 180.438 for residues of
lambda-cyhalothrin on the same crops for which use is requested for the
enriched isomer gamma-cyhalothrin. These tolerances for lambda-
cyhalothrin will be adequate to cover residues of the enriched isomer
based on the relative application rates and the results of the side-by-
side field trials comparing residues from the two products. Based on
the submitted comparison studies of gamma- and lambda-cyhalothrin for
tomato (gamma - 0.018 ppm: lambda 0.038 ppm), sweet corn (gamma - 0.68
ppm: lambda - 1.55 ppm), broccoli (gamma - 0.042 ppm: lambda - 0.13
ppm), and cottonseed (gamma - 0.018: lambda - 0.058),EPA concludes that
on average, residues from the gamma uses are not greater than half of
the residues from lambda uses (the application rates for gamma-
cyhalothrin are half of those of lambda-cyhalothrin for all field
trials). Further, toxicological endpoints selected for gamma-
cyhalothrin are not less than half of the lambda-cyhalothrin endpoints
(i.e., gamma-cyhalothrin is not more than twice as toxic as lambda-
cyhalothrin). Therefore, risks from the two products are expected to be
similar. EPA's previous risk assessment on lambda-cyhalothrin (cited in
67 FR 60902, (FRL-7200-1)) is sufficient to cover gamma-cyhalothrin.
Accordingly, a new aggregate risk assessment for gamma-cyhalothrin is
not needed. Acute dietary exposure, chronic dietary exposure, cancer
risk, and anticipated residues and percent crop treated (PCT)
information, dietary exposure from drinking water, cumulative exposure
to substances with a common mechanism of toxicity, and safety factors
for infants and children are discussed in detail in the Federal
Register of September 27, 2002 (67 FR 60902) (FRL-7200-1) and are not
repeated here.
D. Aggregate Risks and Determination of Safety
Based on the toxicological endpoints selected for gamma-
cyhalothrin, which are not less than half of those selected for lambda-
cyhalothrin, and the residue data from the comparison studies, which
showed that residues from gamma uses are, on average, no more than half
of those of lambda-cyhalothrin, EPA concludes that the previous risk
assessment on lambda-cyhalothrin sufficiently covers the gamma-
cyhalothrin uses and no new aggregate risk assessment is needed for
gamma-cyhalothrin.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methods are available for determination of
lambda-cyhalothrin residues in plant and animal commodities. (ICI)
Method 81 (PRAM) 81) is used to determine the residues of lambda-
cyhalothrin and its epimer in plant matrices and ICI Method 86 is used
to determine residues of lambda-cyhalothrin and its epimer in animal
matrices. Both methods have been validated by EPA as adequate
enforcement methods for determination of parent lambda-cyhalothrin and
its epimer in the respective matrices. ICI Method 96 is used to
determine lambda-cyhalothrin metabolites in eggs, meat, milk, and
poultry. The LOQ for all three methods is 0.01 ppm. Since gamma- and
lambda-cyhalothrin differ only in the relative content of enantiomer
and the enforcement methods do not use chiral columns, the lambda
methods are applicable to gamma-cyhalothrin.
B. International Residue Limits
There are currently no Mexican, Canadian, or Codex MRLs (maximum
residue limits) for gamma- or lambda-cyhalothrin; however, there are
MRLs for cyhalothrin from which lambda-cyhalothrin is derived as an
enriched isomer. A Codex MRLs of 0.2 part per million (ppm) has been
established for pome fruits for cyhalothrin, which is inconsistent with
the proposed U.S. lambda-cyhalothrin tolerance of 0.3 ppm for pome
fruits. It is unclear if harmonization can be achieved because residues
up to 0.25 ppm were found in the U.S. trials for apples. Codex MRLs
were not established for the other crops presently under consideration.
C. Magnitude of Residues
The submitted residue comparison studies on broccoli, cottonseed,
sweet corn, and tomato indicated that on average, residues from the
gamma uses are not greater than half of the residues from lambda uses.
The application rates for gamma-cyhalothrin are half of those
[[Page 18486]]
of lambda-cyhalothrin for all field trials. The analytical method
validation for the determination of gamma- and lambda-cyhalothrin has
also been submitted. This method determines the active isomer and its
enantiomer as one peak and the two epimers as a separate peak. The two
peaks are summed to give total residues.
V. Conclusion
EPA concludes that the data on gamma-cyhalothrin in conjunction
with that on lambda-cyhalothrin show that aggregate risks from dietary
exposure is basically the same as lambda-cyhalothrin and that existing
crop tolerances for lambda-cyhalothrin are adequate to account for the
use of gamma-cyhalothrin on the same crops. Therefore, the tolerance
expression under 40 CFR 180.438 is being amended to include the isomer
gamma-cyhalothrin.
VI. Objections and Hearing Requests
Under section 408(g) of FFDCA, as amended by 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 FFDCA by FQPA, EPA
will continue to use those procedures, with appropriate adjustments,
until the necessary modifications can be made. The new section 408(g)
of FFDCA 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) of FFDCA, as was
provided in the old sections 408 and 409 of FFDCA. 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 ID number OPP-2004-0025 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 June 7,
2004.
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 (1900C),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001. You may also deliver your request to the
Office of the Hearing Clerk in Rm.104, Crystal Mall 2, 1921
Jefferson Davis Hwy., Arlington, VA. 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
(703) 603-0061.
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 [email protected],
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-
0001.
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 20460-0001.
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 inclusion
in the official record that is described in Unit I.B.1. Mail your
copies, identified by docket ID number OPP-2004-0025, 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-
0001. In person or by courier, bring a copy to the location of the
PIRIB described in Unit I.B.1. You may also send an electronic copy of
your request via e-mail to: [email protected]. 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. Statutory and Executive Order Reviews
This final rule establishes a tolerance under section 408(d) of
FFDCA 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
[[Page 18487]]
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 section 408(d) of FFDCA, 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 section 408(n)(4) of FFDCA. 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. Congressional Review Act
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: March 31, 2004.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
0
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. Section 180.438 is amended by:
0
a. Revising the section heading.
0
b. Removing ``hop, dried cone'' from the table in paragraph (a)(3) and
alphabetically adding it to the table in paragraph (a)(1).
0
c. Removing paragraph (a)(3).
0
d. Redesignating paragraph (a)(2) as new paragraph (a)(3).
0
e. Adding a new paragraph (a)(2).
The amendments read as follows:
Sec. 180.438 Lambda-cyhalothrin and an isomer gamma-cyhalothrin;
tolerances for residues.
(a) * * *
(1) * * *
----------------------------------------------------------------------------------------------------------------
Commodity Parts per million
----------------------------------------------------------------------------------------------------------------
* * * * *
Hop, dried cone....................................... 10
* * * * *
----------------------------------------------------------------------------------------------------------------
(2) Tolerances\1\ are established for the combined residues of the
pyrethroid [gamma-cyhalothrin (the isolated active isomer of lambda-
cyhalothrin) ((S)-'-cyano-3-phenoxybenzyl (Z)-(1R,3R)-3-(2-chloro-
3,3,3-trifluoroprop-1-enyl)-2,2-dimethylcyclopropanecarboxylate)) and
its epimer (R)-'-cyano-3-phenoxybenzyl (Z)-(1R,3R)-3-(2-chloro-3,3,3-
trifluoroprop-1-enyl)-2,2-dimethylcyclopropanecarboxylate in/on the
following commodities
----------------------------------------------------------------------------------------------------------------
Commodity Parts per million
----------------------------------------------------------------------------------------------------------------
Alfalfa, forage....................................... 5
Alfalfa, hay.......................................... 6
Almond, hulls......................................... 1.5
[[Page 18488]]
Apple pomace, wet..................................... 2.50
Aspirated grain fractions............................. 2.0
Avocados (imported)................................... 0.20
Brassica, head and stem, subgroup..................... 0.4
Canola, seed.......................................... 0.15
Cattle, fat........................................... 3
Cattle, meat.......................................... 0.2
Cattle, meat byproducts............................... 0.2
Corn, grain (field and pop)........................... 0.05
Corn, fodder.......................................... 1.0
Corn, forage.......................................... 6.0
Corn, grain flour..................................... 0.15
Corn, sweet, kernel plus cob with husks removed....... 0.05
Cottonseed............................................ 0.05
Dry bulb onion........................................ 0.1
Egg................................................... 0.01
Fruit, pome, group.................................... 0.30
Fruit, stone, group................................... 0.50
Garlic................................................ 0.10
Goat, fat............................................. 3.0
Goat, meat............................................ 0.2
Goat, meat byproducts................................. 0.2
Hog, fat.............................................. 3.0
Hog, meat............................................. 0.2
Hog, meat byproducts.................................. 0.2
Horse, fat............................................ 3.0
Horse, meat........................................... 0.2
Horse, meat byproducts................................ 0.2
Lettuce, head......................................... 2.0
Lettuce, leaf......................................... 2.0
Milk fat (reflecting 0.20 ppm in whole milk........... 5.0
Nut, tree, group...................................... 0.05
Pea and bean, dried shelled,(except soybean), subgroup 0.10
Pea and bean, succulent shelled, subgroup............. 0.01
Peanut................................................ 0.05
Peanut, hay........................................... 3.0
Poultry, fat.......................................... 0.03
Poultry, meat......................................... 0.01
Poultry, meat byproducts.............................. 0.01
Rice, grain........................................... 1.0
Rice, hulls........................................... 5.0
Rice, straw........................................... 1.8
Sheep, fat............................................ 3.0
Sheep, meat........................................... 0.2
Sheep, meat byproducts................................ 0.2
Sorghum, grain........................................ 0.20
Sorghum, grain, forage................................ 0.30
Sorghum, grain, stover................................ 0.50
Soybean............................................... 0.01
Sugarcane............................................. 0.05
Sunflower, forage..................................... 0.20
Sunflower, seed hulls................................. 0.50
Sunflower, oil........................................ 0.30
Sunflowers, seed...................................... 0.20
Tomato................................................ 0.10
Tomato, pomace (dry or wet)........................... 6.0
Vegetables, fruiting, group (except cucurbits)........ 0.20
Vegetables, legume, edible podded, subgroup........... 0.20
Wheat, grain.......................................... 0.05
Wheat, forage......................................... 2.0
Wheat, hay............................................ 2.0
Wheat, straw.......................................... 2.0
Wheat, bran........................................... 2.0
----------------------------------------------------------------------------------------------------------------
\1\ The analytical enforcement methods for lambda-cyhalothrin are applicable for determination of gamma-
cyhalothrin residues in plant and animal commodities.
[[Page 18489]]
* * * * *
[FR Doc. 04-7979 Filed 4-7-04; 8:45 am]
BILLING CODE 6560-50-S