[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
----------------------------------------------------------------------------------------------------------------
              Guideline No.                         Study Type                           Results
----------------------------------------------------------------------------------------------------------------
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..........
----------------------------------------------------------------------------------------------------------------
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).
----------------------------------------------------------------------------------------------------------------
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).
----------------------------------------------------------------------------------------------------------------
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).
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------

[[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).
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
870.6200                                   Sub Neurotoxicity - Rat       NOAEL: 11.4 mg/kg/day
                                            Lambda cyhalothrin.........  LOAEL: Not Established
                                            Cyhalothrin................  None
                                            Gamma cyhalothrin..........
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
                                                                  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.
----------------------------------------------------------------------------------------------------------------

[[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