Document ID: EPA-HQ-OPP-2005-0545-0008
Agency: epa
Document Type: Rule
Title: Lambda-Cyhalothrin; Pesticide Tolerance
Posted Date: 2007-08-15T04:00Z

[Federal Register: August 15, 2007 (Volume 72, Number 157)]
[Rules and Regulations]               
[Page 45656-45663]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr15au07-17]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2005-0545; FRL-8143-1]

 
Lambda-Cyhalothrin; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for the combined 
residues of lambda-cyhalothrin, 1:1 mixture of (S)-[alpha]-cyano-3-
phenoxybenzyl-(Z)-(1R,3R)-3-(2-chloro-3,3,3-trifluoroprop-1-enyl)-2,2-
dimethylcyclopropanecarboxylate and (R)-[alpha]-cyano-3-phenoxybenzyl-
(Z)-(1S,3S)-3-(2-chloro-3,3,3-trifluoroprop-1-enyl)-2,2-
dimethylcyclopropanecarboxylate and its epimer expressed as epimer of 
lambda-cyhalothrin, a 1:1 mixture of (S)-[alpha]-cyano-3-phenoxybenzyl-
(Z)-(1S,3S)-3-(2-chloro-3,3,3-trifluoroprop-1-enyl)-2,2-
dimethylcyclopropanecarboxylate and (R)-[alpha]-cyano-3-phenoxybenzyl-
(Z)-(1R,3R)-3-(2-chloro-3,3,3-trifluoroprop-1-enyl)-2,2-
dimethylcyclopropanecarboxylate in or on cucurbit vegetables (Group 9), 
tuberous and corm vegetables (Subgroup 1C), grass (forage, fodder, and 
hay) (Group 17), barley, buckwheat, oat, rye, wild rice, and 
pistachios. Syngenta Crop Protection, Inc. and the Interregional 
Project No. 4 (IR-4) requested these tolerances under the Federal Food, 
Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective August 15, 2007. Objections and 
requests for hearings must be received on or before October 15, 2007, 
and must be filed in accordance with the

[[Page 45657]]

instructions provided in 40 CFR part 178 (see also Unit I.C. of the 
SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2005-0545. To access the 
electronic docket, go to http://www.regulations.gov, select ``Advanced 

Search,'' then ``Docket Search.'' Insert the docket ID number where 
indicated and select the ``Submit'' button. Follow the instructions on 
the regulations.gov website to view the docket index or access 
available documents. All documents in the docket are listed in the 
docket index available in regulations.gov. Although listed in the 
index, some information is not publicly available, e.g., Confidential 
Business Information (CBI) or other information whose disclosure is 
restricted by statute. Certain other material, such as copyrighted 
material, is not placed on the Internet and will be publicly available 
only in hard copy form. Publicly available docket materials are 
available in the electronic docket at http://www.regulations.gov, or, 

if only available in hard copy, at the OPP Regulatory Public Docket in 
Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., 
Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., 
Monday through Friday, excluding legal holidays. The Docket Facility 
telephone number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: Bonaventure Akinlosotu, Registration 
Division (7505P), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 605-0653; e-mail address: 
akinlosotu.bonaventure@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to those 
engaged in the following activities:
     Crop production (NAICS code 111), e.g., agricultural 
workers; greenhouse, nursery, and floriculture workers; farmers.
     Animal production (NAICS code 112), e.g., cattle ranchers 
and farmers, dairy cattle farmers, livestock farmers.
     Food manufacturing (NAICS code 311), e.g., agricultural 
workers; farmers; greenhouse, nursery, and floriculture workers; 
ranchers; pesticide applicators.
     Pesticide manufacturing (NAICS code 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 to 
provide 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 Access Electronic Copies of this Document?

    In addition to accessing an electronic copy of this Federal 
Register document through the electronic docket at http://www.regulations.gov
, you may access this Federal Register document 

electronically through the EPA Internet under the ``Federal Register'' 
listings at http://www.epa.gov/fedrgstr. You may also access a 

frequently updated electronic version of 40 CFR part 180 through the 
Government Printing Office's pilot e-CFR site at http://www.gpoaccess.gov/ecfr
.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, any person may file an objection to 
any aspect of this regulation and may also request a hearing on those 
objections. You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in 40 CFR part 
178. To ensure proper receipt by EPA, you must identify docket ID 
number EPA-HQ-OPP-2005-0545 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 as required by 40 CFR part 178 on or 
before October 15, 2007.
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing that does not contain any CBI for inclusion in the public 
docket that is described in ADDRESSES. Information not marked 
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA 
without prior notice. Submit this copy, identified by docket ID number 
EPA-HQ-OPP-2005-0545, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 

Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket's normal hours of operation (8:30 a.m. to 4 
p.m., Monday through Friday, excluding legal holidays). Special 
arrangements should be made for deliveries of boxed information. The 
Docket Facility telephone number is (703) 305-5805.

II. Petition for Tolerance

    In the Federal Register of April 14, 2006 (71 FR 19509) (FRL-7771-
7), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 
5F6994) by Syngenta Crop Protection, Inc., 410 Swing Rd., Greensboro, 
NC 27409 and IR-4, 681 U.S. Highway 1 South, North Brunswick, 
NJ 08902-3390. The petition requested that 40 CFR 180.438 be amended by 
establishing a tolerance for combined residues of the insecticide 
lambda-cyhalothrin, (S)-[alpha]-cyano-3-phenoxybenzyl-(Z)-(1R,3R)-3-(2-
chloro-3,3,3-trifluoroprop-1-enyl)-2,2-dimethylcyclopropanecarboxylate 
and (R)-[alpha]-cyano-3-phenoxybenzyl-(Z)-(1S,3S)-3-(2-chloro-3,3,3-
trifluoroprop-1-enyl)-2,2-dimethylcyclopropanecarboxylate and the 
epimer of lambda-cyhalothrin, (S)-[alpha]-cyano-3-phenoxybenzyl-(Z)-
(1S,3S)-3-(2-chloro-3,3,3-trifluoroprop-1-enyl)-2,2-
dimethylcyclopropanecarboxylate and (R)-[alpha]-cyano-3-phenoxybenzyl-
(Z)-(1S,3S)-3-(2-chloro-3,3,3-trifluoroprop-1-enyl)-2,2-
dimethylcyclopropanecarboxylate in or on food commodity crop groupings: 
Cucurbit vegetables (Crop Group 9) at 0.05 parts per million (ppm); 
grass, forage, fodder, hay (Crop Group 17) at 9.0 ppm; tuberous and 
corm vegetables (Crop Subgroup 1-C) at 0.01 ppm; barley, buckwheat, 
oat, rye, grain at 0.05 ppm; barley, bran at 0.2 ppm; oat, rye, forage 
at 2.0 ppm; barley, oat, hay at 2.0 ppm; barley, oat, rye, straw at 
2.0ppm; and wild rice, grain at 1.0 ppm. That notice referenced a 
summary of the petition prepared by Syngenta Crop Protection, Inc., the 
registrant, which is available to the public in the docket, http://www.regulations.gov.
 No

[[Page 45658]]

comments were received on the notice of filing.
    The April 14, 2006 notice announcing the pesticide petition from 
Syngenta Crop Protection, Inc. and IR-4 inadvertently left out the PP 
number for the IR-4 petition though the commodities IR-4 requested were 
proposed. There are actually two petitions (PP 3E6593 and PP 5F6994). 
PP 3E6593 submitted by IR-4 requested that 40 CFR 180.438 be amended by 
establishing a tolerance for combined residues of the insecticide 
lambda-cyhalothrin and its epimer in or on food commodities: Barley, 
buckwheat, oat, rye, grain at 0.05 ppm; barley, bran at 0.2 ppm; oat, 
rye, forage at 2.0 ppm; barley, oat, hay at 2.0 ppm; barley, oat, rye, 
straw at 2.0 ppm; and wild rice, grain at 1.0 ppm. PP 5F6994 submitted 
by Syngenta Crop Protection, Inc., requested that 40 CFR 180.438 be 
amended by establishing a tolerance for combined residues of the 
insecticide lambda-cyhalothrin and its epimer in or on food commodity 
crop groupings: Cucurbit vegetables (Crop Group 9) at 0.05 ppm; grass, 
forage, fodder, hay (Crop Group 17) at 9.0 ppm; tuberous and corm 
vegetables (Crop Subgroup 1-C) at 0.01 ppm.
    In the Federal Register of October 11, 2006 (71 FR 59780) (FRL-
8097-5), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 
6E7077) by Syngenta Crop Protection, Inc., P.O. Box 18300, Greensboro, 
NC 27419-8300. The petition requested that 40 CFR 180.438 be amended by 
establishing a tolerance for the combined residues of the insecticide 
lambda-cyhalothrin in or on pistachio at 0.05 ppm. That notice 
referenced a summary of the petition prepared by Syngenta Crop 
Protection, Inc., the registrant, which is available to the public in 
the docket, http://www.regulations.gov. There were no comments received 

in response to the notice of filing.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical 
residue....'' These provisions were added to FFDCA by the Food Quality 
Protection Act (FQPA) of 1996.
    Consistent with FFDCA section 408(b)(2)(D), and the factors 
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available 
scientific data and other relevant information in support of this 
action. EPA has sufficient data to assess the hazards of and to make a 
determination on aggregate exposure for the petitioned-for tolerance 
for the combined residues of lambda-cyhalothrin in or on cucurbit 
vegetables (Crop Group 9) at 0.05 ppm; grass, forage, fodder and hay 
(Crop Group 17) at 7.0 ppm; tuberous and corm vegetables (Crop Subgroup 
1C) at 0.02 ppm; barley, grain at 0.05 ppm; buckwheat, grain at 0.05 
ppm; oat, grain at 0.05 ppm; rye, grain at 0.05 ppm; barley, bran at 
0.2 ppm; rye, bran at 0.2 ppm; oat, forage at 2.0 ppm; rye, forage at 
2.0 ppm; barley, hay at 2.0 ppm; oat, hay at 2.0 ppm; barley, straw at 
2.0 ppm; oat, straw at 2.0 ppm; rye, straw at 2.0 ppm; rice, wild, 
grain at 1.0 ppm; pistachio at 0.05 ppm; hog, fat at 0.2 ppm; hog, meat 
at 0.01 ppm; hog, meat-byproducts at 0.02 ppm; and milk, fat at 10.0 
ppm (reflecting 0.4 ppm in whole milk). EPA's assessment of exposures 
and risks associated with establishing the tolerance follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children. Specific information on the studies received and the nature 
of the adverse 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 are discussed in the 
final rule published in the Federal Register of April 8, 2004 (69 FR 
18480) (FRL-7353-4).

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no 
appreciable risk, the toxicological level of concern (LOC) is derived 
from the highest dose at which no adverse effects are observed (the 
NOAEL) in the toxicology study identified as appropriate for use in 
risk assessment. However, if a NOAEL cannot be determined, the lowest 
dose at which adverse effects of concern are identified (the LOAEL) is 
sometimes used for risk assessment. Uncertainty/safety factors (UF) are 
used in conjunction with the LOC to take into account 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. Safety is assessed for acute and chronic 
risks by comparing aggregate exposure to the pesticide to the acute 
population adjusted dose (aPAD) and chronic population adjusted dose 
(cPAD). The aPAD and cPAD are calculated by dividing the LOC by all 
applicable UFs. Short-, intermediate-, and long-term risks are 
evaluated by comparing aggregate exposure to the LOC to ensure that the 
margin of exposure (MOE) called for by the product of all applicable 
UFs is not exceeded.
    For non-threshold risks, the Agency assumes that any amount of 
exposure will lead to some degree of risk and estimates risk in terms 
of the probability of occurrence of additional adverse cases. 
Generally, cancer risks are considered non-threshold. For more 
information on the general principles EPA uses in risk characterization 
and a complete description of the risk assessment process, see http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm
.

    A summary of the toxicological endpoints for lambda-cyhalothrin 
used for human risk assessment is discussed in Unit III.B. of the final 
rule published in the Federal Register of April 8, 2004 (69 FR 18480) 
(FRL-7353-4).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to lambda-cyhalothrin, EPA considered exposure under the 
petitioned-for tolerances as well as all existing lambda-cyhalothrin 
tolerances in (40 CFR 180.438). EPA assessed dietary exposures from 
lambda-cyhalothrin in food as follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk 
assessments are performed for a food-use pesticide, if a toxicological 
study has indicated the possibility of an effect of concern occurring 
as a result of a 1-day or single exposure. In estimating acute dietary 
exposure, EPA used the Dietary

[[Page 45659]]

Exposure Evaluation Model (DEEM-FCID\(TM)\, Version 2.03) which uses 
food consumption information from the United States Department of 
Agriculture's (USDA) 1994-1996 and 1998 Nationwide Continuing Surveys 
of Food Intake by Individuals (CSFII). A refined acute probabilistic 
dietary exposure assessment was performed for lambda-cyhalothrin which 
included all existing and proposed food uses and drinking water. The 
acute dietary exposure assessment incorporated processing factors and 
percent crop treated (PCT) estimates. Acute anticipated residues were 
derived from USDA's Pesticide Data Program (PDP) monitoring data, field 
trial studies, and a market basket survey for beef-fat.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment, EPA used DEEM-FCID\(TM)\, Version 2.03 which uses food 
consumption information from the USDA's 1994-1996 and 1998 CSFII. As to 
residue levels in food, EPA conducted a refined chronic dietary 
exposure assessment for lambda-cyhalothrin to support all existing and 
proposed food uses, utilizing a single-point estimate of anticipated 
residues for food and drinking water. The chronic dietary exposure 
assessment incorporated processing factors and PCT estimates. Chronic 
anticipated residues were derived from PDP monitoring data, field trial 
studies, and a market basket survey for beef-fat.
    iii.Cancer. Lambda-cyhalothrin is classified as ``not likely to be 
carcinogenic to humans.'' Therefore, there is no cancer risk associated 
with existing or proposed uses.
    iv. Anticipated residue and percent crop treated (PCT) information. 
Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and 
information on the anticipated residue levels of pesticide residues in 
food and the actual levels of pesticide residues that have been 
measured in food. If EPA relies on such information, EPA must pursuant 
to FFDCA section 408(f)(1) require that data be provided 5 years after 
the tolerance is established, modified, or left in effect, 
demonstrating that the levels in food are not above the levels 
anticipated. For the present action, EPA will issue such data call-ins 
as are required by FFDCA section 408(b)(2)(E) and authorized under 
FFDCA section 408(f)(1). Data will be required to be submitted no later 
than 5 years from the date of issuance of this tolerance.
    Section 408(b)(2)(F) of FFDCA states that the Agency may use data 
on the actual percent of food treated for assessing chronic dietary 
risk only if:
    a. The data used are reliable and provide a valid basis to show 
what percentage of the food derived from such crop is likely to contain 
such pesticide residue.
    b. The exposure estimate does not underestimate exposure for any 
significant subpopulation group.
    c. Data are available on pesticide use and food consumption in a 
particular area, the exposure estimate does not understate exposure for 
the population in such area. In addition, the Agency must provide for 
periodic evaluation of any estimates used. To provide for the periodic 
evaluation of the estimate of PCT as required by section 408(b)(2)(F) 
of FFDCA, EPA may require registrants to submit data on PCT.
    The Agency used PCT information as follows:
    PCT estimates of agricultural uses for lambda-cyhalothrin were 
obtained in the form of a screening-level usage assessment (SLUA), 
based on data years 1999-2004. Average and maximum values for percent 
crop treated data were used in the chronic and acute analyses, 
respectively, for the following commodities with established 
tolerances: Almonds (5 chronic, 5 acute), Apples (5 chronic, 10 acute), 
Beans, Green (10 chronic, 20 acute), Broccoli (10 chronic, 20 acute), 
Cabbage (30 chronic, 45 acute), Canola/Rapeseed (1 chronic, 2.5 acute), 
Cauliflower (20 chronic, 30 acute), Cherries (5 chronic, 15 acute), 
Corn (1 chronic, 2.5 acute), Cotton (10 chronic, 10 acute), Dry Beans/
Peas (1 chronic, 2.5 acute), Garlic (10 chronic, 30 acute), Lettuce (30 
chronic, 45 acute), Onions (50 chronic, 55 acute), Peaches (5 chronic, 
10 acute), Peanuts (5 chronic, 10 acute), Pears (15 chronic, 30 acute), 
Peas, Green (1 chronic, 2.5 acute), Pecans (1 chronic, 5 acute), 
Peppers (5 chronic, 15 acute), Prunes and Plums (5 chronic, 5 acute), 
Rice (15 chronic, 30 acute), Sorghum (1 chronic, 2.5 acute), Soybeans 
(5 chronic, 10 acute), Sugarcane (5 chronic, 10 acute), Sunflowers (10 
chronic, 20 acute), Sweet Corn (45 chronic, 60 acute), Tomatoes (20 
chronic, 20 acute), and Wheat (1 chronic, 2.5 acute). For all other 
commodities and for new uses, 100% PCT was assumed. Tolerance level 
values were used for the following commodities: Okra, eggplant, 
poultry, tree nuts group (crop group 14) except almonds and pecans, and 
tuberous and corm vegetables subgroup (crop subgroup 1C) except 
potatoes.
    EPA uses an average PCT for chronic dietary risk analysis. The 
average PCT figure for each existing use is derived by combining 
available Federal, State, and private market survey data for that use, 
averaging by year, averaging across all years, and rounding up to the 
nearest multiple of 5% except for those situations in which the average 
PCT is less than one. In those cases < 1% is used as the average and 
< 2.5% is used as the maximum. EPA uses a maximum PCT for acute dietary 
risk analysis. The maximum PCT figure is the single maximum value 
reported overall from available Federal, State, and private market 
survey data on the existing use, across all years, and rounded up to 
the nearest multiple of 5%. In most cases, EPA uses available data from 
United States Department of Agriculture/National Agricultural 
Statistics Service (USDA/NASS), Proprietary Market Surveys, and the 
National Center for Food and Agriculture Policy (NCFAP) for the most 
recent 6 years.
    The Agency believes that the three conditions listed in Unit 
III.C.1.iv. have been met. With respect to Condition 1, PCT estimates 
are derived from Federal and private market survey data, which are 
reliable and have a valid basis. The Agency is reasonably certain that 
the percentage of the food treated is not likely to be an 
underestimation. As to Conditions 2 and 3, regional consumption 
information and consumption information for significant subpopulations 
is taken into account through EPA's computer-based model for evaluating 
the exposure of significant subpopulations including several regional 
groups. Use of this consumption information in EPA's risk assessment 
process ensures that EPA's exposure estimate does not understate 
exposure for any significant subpopulation group and allows the Agency 
to be reasonably certain that no regional population is exposed to 
residue levels higher than those estimated by the Agency. Other than 
the data available through national food consumption surveys, EPA does 
not have available information on the regional consumption of food to 
which lambda-cyhalothrin may be applied in a particular area.
    2. Dietary exposure from drinking water. The Agency lacks 
sufficient monitoring data to complete a comprehensive dietary exposure 
analysis and risk assessment for lambda-cyhalothrin in drinking water. 
Because the Agency does not have comprehensive monitoring data, 
drinking water concentration estimates are made by reliance on 
simulation or modeling taking into account data on the environmental 
fate characteristics of lambda-cyhalothrin. Further information 
regarding EPA drinking water models used in pesticide exposure 
assessment can be found at

[[Page 45660]]

http://www.epa.gov/oppefed1/models/water/index.htm.

    Based on the First Index Reservoir Screening Tool (FIRST) and 
Screening Concentrations in Groundwater (SCI-GROW) models, the 
estimated drinking water concentrations (EDWCs) of lambda-cyhalothrin 
for acute exposures are estimated to be 5.35 parts per billion (ppb) 
for surface water and 0.00336 ppb for ground water. The EECs for 
chronic exposures are estimated to be 0.130 ppb for surface water and 
0.00336 ppb for ground water. The EDWCs for lambda-cyhalothrin were 
calculated based on a maximum application rate of 0.5 pounds active 
ingredient per acre per season (lb a.i./A/season) for orchards (ground 
application) for surface and groundwater concentrations. A default 
percent crop area (PCA) factor of 0.87 (87%) was applied to the 
orchards scenario. The orchards scenario using the FIRST model produced 
the highest concentrations.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For acute dietary risk 
assessment, the water concentration value of 5.35 ppb was used to 
assess the contribution to drinking water. For chronic dietary risk 
assessment, the water concentration of value 0.130 ppb was used to 
assess the contribution to drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets).
    Lambda-cyhalothrin is currently registered for the following 
residential non-dietary sites: Ornamental gardens, lawns, landscapes, 
turf, golf courses, and general insect control (spot treatments, and 
crack and crevice treatments) in, around, and on buildings, structures, 
and immediate surroundings. All registered products, except for one 
aerosol can product, are limited to use only by certified applicators. 
As such, this assessment ADDRESSES the single-residential handler 
scenario for aerosol can users, and post-application scenarios 
associated with any use in a residential environment. Both short-term 
and intermediate-term exposures are possible.
    For the residential assessment, existing uses on turf, in gardens, 
on golf courses, and for structural pest control were considered, but a 
quantitative calculation was only completed for post-application 
exposure on treated turf. The Agency used a conservative screening-
level approach to address the risks associated with the use of the 
aerosol can product of lambda-cyhalothrin that can be purchased and 
used by homeowners.
    A screening-level quantitative calculation was completed for post-
application exposure on treated turf only because this scenario is 
expected to have the highest associated exposures of all residential 
exposures. EPA believes that the selected post-application assessment 
on lawns for children is protective for all residential exposures (even 
the aerosol can handler scenario) because the dose levels for children 
playing on treated lawns are thought to exceed those expected for all 
other scenarios (lawn exposures for children represents the worst-case 
scenario). This approach is based on the following conservative 
considerations:
    i. EPA assumed that children contacted lawns immediately after 
application of lawn product and thus there was no dissipation of 
residues from the treated lawn.
    ii. EPA estimated dermal exposure based on a high duration of 
exposure on the lawn and an intensity of activity that results in a 
high degree of contact with the treated lawn.
    iii. EPA assumed that the pesticide was applied at the maximum 
application rate.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    Lambda-cyhalothrin is a member of the pyrethroid class of 
pesticides. Although all pyrethroids alter nerve function by modifying 
the normal biochemistry and physiology of nerve membrane sodium 
channels, EPA is not currently following a cumulative risk approach 
(based on a common mechanism of toxicity) for the pyrethroids. Although 
pyrethroids interact with sodium channels, there are multiple types of 
sodium channels, and it is currently unknown whether pyrethroids have 
similar effects on all channels. Nor is there a clear understanding of 
effects on key downstream neuronal function (nerve excitability), nor 
do we understand how these key events interact to produce their 
compound specific patterns of neurotoxicity. There is ongoing research 
by the EPA's Office of Research and Development (and pyrethroid 
registrants) to evaluate the differential biochemical and physiological 
actions of pyrethroids in mammals. When available, the Agency will 
consider this research, and make a determination of common mechanism as 
a basis for assessing cumulative risk. For information regarding EPA's 
efforts to determine which chemicals have a common mechanism of 
toxicity and to evaluate the cumulative effects of such chemicals, see 
EPA's website at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408 of FFDCA provides that EPA shall apply 
an additional (``10X'') tenfold margin of safety for infants and 
children in the case of threshold effects to account for prenatal and 
postnatal toxicity and the completeness of the database on toxicity and 
exposure unless EPA determines based on reliable data that a different 
margin of safety will be safe for infants and children. This additional 
margin of safety is commonly referred to as the FQPA safety factor. In 
applying this provision, EPA either retains the default value of 10X 
when reliable data do not support the choice of a different factor, or, 
if reliable data are available, EPA uses a different additional FQPA 
safety factor value based on the use of traditional UFs and/or special 
FQPA safety factors, as appropriate.
    2. The completeness of the database. The toxicology database is 
considered complete for the purposes of an FQPA risk assessment. Based 
on the developmental studies in rats and rabbits, and the 3-generation 
and neurodevelopmental studies in rats, there is no evidence of 
increased susceptibility. The neurotoxicity observed in adult animal 
studies raised a concern for potential neurodevelopmental effects. A 
rat developmental neurotoxicity (DNT) study is available. In this 
study, the lowest dose showing neurotoxicity in the offspring (effects 
on mortality, body weights, body weight gains, learning, learning and 
memory, and brain morphometry) is 10 milligram/kilogram body weight/day 
(mg/kg bw/day), with a NOAEL of 4 mg/kg bw/day. Effects in offspring 
and adult animals are found at a similar dose based on body weight 
decreases. It should be noted that some of the parameters evaluated in 
this DNT study were regarded as acceptable but several others were not, 
leading to a study classification of ``unacceptable.'' The study 
deficiencies which, taken together, led to the unacceptable 
classification include:
    i. Statistical analyses that adjusted for body weights after 
treatment had begun.

[[Page 45661]]

    ii. An inadequate assessment of motor activity.
    iii. An inadequate assessment of auditory startle in postnal day 
(PND) 61 females.
    iv. Missing low- and mid-dose morphometry data.
However, it is not likely that these limitations will impact the risk 
assessment for the following reasons. The slight changes in brain 
morphometry were seen at the highest dose tested. Because these changes 
were slight, it is uncertain whether toxicologically significant 
differences would be seen at the mid dose, and it is unlikely that 
significant changes would be seen at the lowest dose tested. The 
auditory startle response is considered adequate for assessment in PND 
23 males/females and PND 61 males where no treatment-related effects 
were seen in auditory startle response. Only the auditory response data 
for PND 61 females is inadequate. Motor activity was examined and there 
did not appear to be any differences between treated and control 
animals other than decreases for multiple subsessions in PND 18 males/
females at the high dose only, but due to the high variability and the 
lack of habituation, these data are considered equivocal. There was no 
published literature found that would indicate a neurodevelopmental 
concern for lambda-cyhalothrin.
    The exposure assessments are based on reliable data and reasonable 
worst-case assumptions, and are not likely to underestimate exposure. 
Reliable data on anticipated dietary residues was relied upon including 
crop field trial studies and monitoring data. Conservative ground and 
surface water modeling estimates were used. Similarly, conservative 
Residential Standard Operating Procedures were used to assess post-
application exposure to children as well as incidental oral exposure of 
toddlers. These assessments will not underestimate the exposure and 
risks posed by lambda-cyhalothrin.
    3. Prenatal and postnatal sensitivity. No quantitative or 
qualitative evidence of increased susceptibility of rat or rabbit 
fetuses to in utero exposure in the developmental studies was observed. 
No developmental toxicity was observed in either of these studies. No 
quantitative or qualitative evidence of increased susceptibility was 
observed in the 3-generation reproduction study in rats. Offspring 
toxicity (decreased pup weight and pup weight gain) was observed in the 
reproduction study at the same dose level as parental toxicity 
(decreased body weight and body weight gain). These effects are not 
considered to be more severe than the effects in the parents.
    EPA has received a DNT for lambda-cyhalothrin (Master Record 
Identification Number 46449102), which was classified as unacceptable/
guideline due to inadequacies in some of the developmental parameters 
tested. Nonetheless, for the reasons noted in Unit VII.D.2., EPA does 
not believe that correction of the deficiencies in this study would 
meaningfully change its evaluation of the risk posed by lambda-
cyhalothrin and is not requiring that the study be repeated. In any 
event, if a 10-fold factor is applied to this study's NOAEL, (i.e., 4 
mg/kg bw/day) to account for the scientific limitations of the study, 
the resulting value is 0.4 mg/kg bw/day. This estimate of 0.4 mg/kg/day 
is similar to the doses from the chronic dog study used for risk 
assessment (i.e., 0.5 mg/kg/day for acute dietary exposure scenarios 
and 0.1 mg/kg/day for chronic dietary exposure scenarios). Therefore, 
EPA concludes that using the NOAELs from the dog study would not 
underestimate risks to infants and children from exposure to lambda-
cyhalothrin, and consequently, a repeat rat DNT study is not required.
    4. Conclusion. EPA has determined that reliable data show that it 
would be safe for infants and children to reduce the FQPA safety factor 
to 1X. That decision is based on the following findings:
    i. The toxicity database for lambda-cyhalothrin is considered 
complete for the purpose of an FQPA assessment.
    ii. All doses and endpoints for risk assessment are based on 
neurotoxic effects seen in the dog, widely known as the most sensitive 
test species for pyrethroids.
    iii. There is no evidence that lambda-cyhalothrin results in 
increased susceptibility in in utero rats or rabbits in the prenatal 
developmental studies or in young rats in the 2-generation reproduction 
study. The acceptable parameters of the developmental neurotoxicity 
study in rats do not indicate increased susceptibility to pups exposed 
in utero.
    iv. The exposure assessments are based on reliable data and 
reasonable worst-case assumptions, and are not likely to underestimate 
exposure.
    Based on all of the considerations in Unit III.D.3., there is not a 
need to retain the additional 10X safety factor for children. 
Application of the 10X intraspecies uncertainty factor (which accounts 
for the possibility that a subpopulation may be 10 times more sensitive 
than the average individual) and a 10X interspecies factor (which 
accounts for the possibility that humans may be 10 times more sensitive 
than animals) to the dog NOAEL (i.e., the most sensitive species) 
should assure protection of human health including children. Therefore, 
EPA has determined that reliable data show that it would be safe for 
infants and children to reduce the FQPA safety factor to 1X.

E. Aggregate Risks and Determination of Safety

    Safety is assessed for acute and chronic risks by comparing 
aggregate exposure to the pesticide to the aPAD and cPAD. The aPAD and 
cPAD are calculated by dividing the LOC by all applicable UFs. For 
linear cancer risks, EPA calculates the probability of additional 
cancer cases given aggregate exposure. Short-, intermediate-, and long-
term risks are evaluated by comparing aggregate exposure to the LOC to 
ensure that the MOE called for by the product of all applicable UFs is 
not exceeded.
    1. Acute risk. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food and water 
to lambda-cyhalothrin will occupy 46% of the aPAD for the general U.S. 
population, and 61% of the aPAD for all infants (< 1 year old), the most 
highly exposed population subgroup.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to lambda-
cyhalothrin from food and water will utilize 17% of the cPAD for the 
general U.S. population, and 50% of the cPAD for children (1-2 years 
old), the most highly exposed population subgroup. Based on the use 
pattern, chronic residential exposure to residues of lambda-cyhalothrin 
is not expected.
    3. Short-term and intermediate-term risk. Short-term and 
intermediate-term aggregate exposure takes into account residential 
exposure plus chronic exposure to food and water (considered to be a 
background exposure level).
    Lambda-cyhalothrin is currently registered for use that could 
result in short-term and intermediate-term residential exposure and the 
Agency has determined that it is appropriate to aggregate chronic food 
and water and short-term exposures for lambda-cyhalothrin.
    Using the exposure assumptions described in this unit for short-
term and intermediate-term exposures, EPA has concluded that food, 
water, and residential exposures aggregated result in aggregate MOEs of 
140 to 490. The residential MOEs were aggregated together because, 
regardless of the exposure route (dermal, inhalation, or

[[Page 45662]]

oral), lambda-cyhalothrin has similar adverse effects (neurotoxicity). 
This aggregate risk assessment incorporates lawn post-application 
exposure (the scenario with the highest potential for exposure), and is 
a day-0 screening-level assessment. The resulting aggregate MOEs were 
greater than the Agency target MOE of 100 (ranging from 140 to 490), 
and there were thus no concerns for aggregate exposure.
    4. Aggregate cancer risk for U.S. population. Lambda-cyhalothrin is 
classified as ``not likely to be carcinogenic to humans.'' Therefore, 
there is no aggregate cancer risk associated with the existing or 
proposed uses.
    5. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, or to infants and children from aggregate 
exposure to lambda-cyhalothrin residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (gas chromatography/electron 
capture detector (GC/ECD) methods are available for enforcing 
tolerances for lambda-cyhalothrin residues in plant and animal 
commodities. The method may be requested from: Chief, Analytical 
Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. 
Meade, MD 20755-5350; telephone number: (410) 305-2905; e-mail address: 
residuemethods@epa.gov.

B. International Residue Limits

    The Codex Alimentarius Commission, Mexico, and Canada have all 
established maximum residue limits (MRLs) for residues of lambda-
cyhalothrin in or on a variety of raw agricultural commodities. These 
regulatory bodies express residues in terms of only cyhalothrin (Codex) 
or of lambda-cyhalothrin (Canada, Mexico); none of these tolerances 
include the epimer R157836 found in the U.S. tolerance expression. EPA 
includes the epimer due to it being considered as toxic as the active 
ingredient and its presence at quantifiable levels in many crops. For 
the crop uses currently under consideration, only potatoes have 
existing international tolerances. Although the recommended 0.02 ppm 
U.S. tolerance agrees numerically with the Codex and Mexican MRLs, 
strictly speaking they are not in harmony due to the different residue 
definitions.

C. Response to Comments

    Several comments were received from a private citizen objecting to 
IR-4 petitioning for tolerances, pesticide residues on food and the 
establishment of these tolerances. The Agency has received similar 
comments from this commenter on numerous previous occasions. Refer to 
the Federal Registers of June 30, 2005 (70 FR 37686) (FRL-7718-3), 
January 7, 2005 (70 FR 1354) (FRL-7691-4), and October 29, 2004 (69 FR 
63096-63098) (FRL-7681-9) for the Agency's response to these 
objections. In addition, the commenter noted several adverse effects 
seen in animal toxicology studies with lambda-cyhalothrin and claims 
because of these effects no tolerance should be approved. EPA has 
found, however, that there is a reasonable certainty of no harm to 
humans after considering these toxicological studies and the exposure 
levels of humans to lambda-cyhalothrin. The commenter also identified 
potential effects on the environment. This comment is considered 
irrelevant because the safety standard for approving tolerances under 
section 408 of FFDCA focuses on potential harms to human health and 
does not permit consideration of effects on the environment. Effects on 
the environment were considered by EPA in the registration process for 
lambda-cyhalothrin under the Federal Insecticide, Fungicide, and 
Rodenticide Act, 7 U.S.C. 136 et seq.

V. Conclusion

    Modifications to the pesticide petitions included in this final 
rule include: Grass, (forage, fodder, hay) from 9.0 ppm to 7.0 ppm 
because a crop group tolerance is appropriate--grass forage, fodder, 
and hay (Group 17); rye, bran at 0.2 ppm based on the existing residue 
data and tolerances in similar wheat commodities; hog, fat from 3.0 ppm 
to 0.2 ppm, hog, meat from 0.2 ppm to 0.01 ppm, hog, and meat-
byproducts from 0.2 ppm to 0.02 ppm based on a Theoretical Dietary 
Burden (TDB) of 0.9 ppm for swine, the maximum expected residues are 
0.16 ppm in hog fat, 0.006 ppm in hog meat, and 0.011 ppm in hog meat-
byproducts; and milk, fat from 5.0 ppm to 10.0 ppm based on a TDB of 
10.4 ppm for dairy cattle, the maximum expected residues in milk are 
0.35 ppm, equivalent to 8.8 ppm in milk fat.
    Therefore, the tolerances are established for the combined residues 
of lambda-cyhalothrin, 1:1 mixture of (S)-[alpha]-cyano-3-
phenoxybenzyl-(Z)-(1R,3R)-3-(2-chloro-3,3,3-trifluoroprop-1-enyl)-2,2-
dimethylcyclopropanecarboxylate and (R)-[alpha]-cyano-3-phenoxybenzyl-
(Z)-(1S,3S)-3-(2-chloro-3,3,3-trifluoroprop-1-enyl)-2,2-
dimethylcyclopropanecarboxylate and its epimer expressed as epimer of 
lambda-cyhalothrin, a 1:1 mixture of (S)-[alpha]-cyano-3-phenoxybenzyl-
(Z)-(1S,3S)-3-(2-chloro-3,3,3-trifluoroprop-1-enyl)-2,2-
dimethylcyclopropanecarboxylate and (R)-[alpha]-cyano-3-phenoxybenzyl-
(Z)-(1R,3R)-3-(2-chloro-3,3,3-trifluoroprop-1-enyl)-2,2-
dimethylcyclopropanecarboxylate, in or on cucurbit vegetables (Crop 
Group 9) at 0.05 ppm; grass, forage, fodder and hay (Crop Group 17) at 
7.0 ppm; tuberous and corm vegetables (Crop Subgroup 1C) at 0.02 ppm; 
barley, grain at 0.05 ppm; buckwheat, grain at 0.05 ppm; oat, grain at 
0.05 ppm; rye, grain at 0.05 ppm; barley, bran at 0.2 ppm; rye, bran at 
0.2 ppm; oat, forage at 2.0 ppm; rye, forage at 2.0 ppm; barley, hay at 
2.0 ppm; oat, hay at 2.0 ppm; barley, straw at 2.0 ppm; oat, straw at 
2.0 ppm; rye, straw at 2.0 ppm; rice, wild, grain at 1.0 ppm; pistachio 
at 0.05 ppm; hog, fat at 0.2 ppm; hog, meat at 0.01 ppm; hog, meat-
byproducts at 0.02 ppm; and milk, fat at 10.0 ppm (reflecting 0.4 ppm 
in whole milk).

VI. 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, 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) or Executive Order 13045, entitled Protection of Children 
from Environmental Health Risks and Safety Risks (62 FR 19885, April 
23, 1997). This final rule does not contain any information collections 
subject to OMB approval under the Paperwork Reduction Act (PRA), 44 
U.S.C. 3501 et seq., nor does it require any special considerations 
under Executive Order 12898, entitled Federal Actions to Address 
Environmental Justice in Minority Populations and Low-Income 
Populations (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under 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.

[[Page 45663]]

    This final rule directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of section 408(n)(4) of FFDCA. As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled Federalism (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
Consultation and Coordination with Indian Tribal Governments (65 FR 
67249, November 6, 2000) do not apply to this rule. In addition, this 
rule does not impose any enforceable duty or contain any unfunded 
mandate as described under Title II of the Unfunded Mandates Reform Act 
of 1995 (UMRA) (Public Law 104-4).
    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).

VII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report 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: August 3, 2007.
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:
     i. Revising the entries ``hog, fat;'' ``hog, meat;'' ``hog, meat 
byproducts;'' and ``milk, fat (reflecting 0.4 ppm in whole milk)'' in 
the table in paragraph (a) (1).
     ii. Adding alphabetically the following commodities to the table 
in paragraph (a)(1) to read as follows:

Sec. 180.438  Lambda-cyhalothrin and an isomer gamma-cyhalothrin; 
tolerances for residues.

    (a) * * *
    (1) * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
                                * * * * *
Barley, bran...............................................          0.2
Barley, grain..............................................         0.05
Barley, hay................................................          2.0
Barley, straw..............................................          2.0
                                * * * * *
Buckwheat, grain...........................................         0.05
                                * * * * *
Grass, forage, fodder and hay, group 17....................          7.0
 Hog, fat..................................................          0.2
Hog, meat..................................................         0.01
Hog, meat byproducts.......................................         0.02
                                * * * * *
Milk, fat (reflecting 0.4 ppm in whole milk)...............         10.0
                                * * * * *
Oat, grain.................................................         0.05
Oat, forage................................................          2.0
Oat, hay...................................................          2.0
Oat, straw.................................................          2.0
                                * * * * *
Pistachio..................................................         0.05
                                * * * * *
Rice, wild, grain..........................................          1.0
Rye, bran..................................................          0.2
Rye, grain.................................................         0.05
Rye, forage................................................          2.0
Rye, straw.................................................          2.0
                                * * * * *
Vegetable, cucurbit, group 9...............................         0.05
                                * * * * *
Vegetable, tuberous and corm, subgroup 1C..................         0.02
                                * * * * *
------------------------------------------------------------------------

[FR Doc. E7-16050 Filed 8-14-07; 8:45 am]

BILLING CODE 6560-50-S