[Federal Register Volume 65, Number 93 (Friday, May 12, 2000)]
[Notices]
[Pages 30591-30596]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-11871]


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ENVIRONMENTAL PROTECTION AGENCY

[PF-926; FRL-6497-1]


Notice of Filing Pesticide Petitions to Establish a Tolerance for 
Certain Pesticide Chemicals in or on Food

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces the initial filing of a pesticide 
petition proposing the establishment of regulations for residues of 
certain pesticide chemicals in or on various food commodities.

DATES: Comments, identified by docket control number PF-914, must be 
received on or before June 12, 2000.

ADDRESSES: Comments may be submitted by mail, electronically, or in 
person. Please follow the detailed instructions for each method as 
provided in Unit I.C. of the SUPPLEMENTARY INFORMATION. To ensure 
proper receipt by EPA, it is imperative that you identify docket 
control number PF-926 in the subject line on the first page of your 
response.

FOR FURTHER INFORMATION CONTACT: By mail: Tracy Keigwin, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, Ariel Rios Bldg., 1200 Pennsylvania Ave., NW., 
Washington, DC 20460; telephone number: (703) 305-6605; e-mail address: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

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

 
------------------------------------------------------------------------
                                                          Examples of
           Categories                 NAICS codes         potentially
                                                       affected entities
------------------------------------------------------------------------
Industry                          111                 Crop production
                                  112                 Animal production

[[Page 30592]]

 
                                  311                 Food manufacturing
                                  32532               Pesticide
                                                       manufacturing
------------------------------------------------------------------------

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

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

    1. Electronically. You may obtain electronic copies of this 
document, and certain other related documents that might be available 
electronically, from the EPA Internet Home Page at http://www.epa.gov/. 
To access this document, on the Home Page select ``Laws and 
Regulations'' and then look up the entry for this document under the 
``Federal Register--Environmental Documents.'' You can also go directly 
to the Federal Register listings at http://www.epa.gov/fedrgstr/.
    2. In person. The Agency has established an official record for 
this action under docket control number PF-926. The official record 
consists of the documents specifically referenced in this action, any 
public comments received during an applicable comment period, and other 
information related to this action, including any information claimed 
as confidential business information (CBI). This official record 
includes the documents that are physically located in the docket, as 
well as the documents that are referenced in those documents. The 
public version of the official record does not include any information 
claimed as CBI. The public version of the official record, which 
includes printed, paper versions of any electronic comments submitted 
during an applicable comment period, is available for inspection in the 
Public Information and Records Integrity Branch (PIRIB), Rm. 119, 
Crystal Mall #2 (CM #2), 1921 Jefferson Davis Highway, Arlington, VA, 
from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal 
holidays. The PIRIB telephone number is (703) 305-5805.

C. How and to Whom Do I Submit Comments?

    You may submit comments through the mail, in person, or 
electronically. To ensure proper receipt by EPA, it is imperative that 
you identify docket control number PF-926 in the subject line on the 
first page of your response.
    1. By mail. Submit your comments to: Public Information and Records 
Integrity Branch (PIRIB), Information Resources and Services Division 
(7502C), Office of Pesticide Programs (OPP), Environmental Protection 
Agency, Ariel Rios Bldg., 1200 Pennsylvania Ave., NW., Washington, DC 
20460.
    2. In person or by courier. Deliver your comments to: Public 
Information and Records Integrity Branch (PIRIB), Information Resources 
and Services Division (7502C), Office of Pesticide Programs (OPP), 
Environmental Protection Agency, Rm. 119, CM #2, 1921 Jefferson Davis 
Highway, Arlington, VA. The PIRIB is open from 8:30 a.m. to 4 p.m., 
Monday through Friday, excluding legal holidays. The PIRIB telephone 
number is (703) 305-5805.
    3. Electronically. You may submit your comments electronically by 
e-mail to: ``[email protected] ,'' or you can submit a computer disk 
as described above. Do not submit any information electronically that 
you consider to be CBI. Avoid the use of special characters and any 
form of encryption. Electronic submissions will be accepted in 
Wordperfect 6.1/8.0 or ASCII file format. All comments in electronic 
form must be identified by docket control number PF-926. Electronic 
comments may also be filed online at many Federal Depository Libraries.

D. How Should I Handle CBI That I Want to Submit to the Agency?

    Do not submit any information electronically that you consider to 
be CBI. You may claim information that you submit to EPA in response to 
this document as CBI 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. In addition to one complete 
version of the comment that includes any information claimed as CBI, a 
copy of the comment that does not contain the information claimed as 
CBI must be submitted for inclusion in the public version of the 
official record. Information not marked confidential will be included 
in the public version of the official record without prior notice. If 
you have any questions about CBI or the procedures for claiming CBI, 
please consult the person identified under FOR FURTHER INFORMATION 
CONTACT.

E. What Should I Consider as I Prepare My Comments for EPA?

    You may find the following suggestions helpful for preparing your 
comments:
    1. Explain your views as clearly as possible.
    2. Describe any assumptions that you used.
    3. Provide copies of any technical information and/or data you used 
that support your views.
    4. If you estimate potential burden or costs, explain how you 
arrived at the estimate that you provide.
    5. Provide specific examples to illustrate your concerns.
    6. Make sure to submit your comments by the deadline in this 
notice.
    7. To ensure proper receipt by EPA, be sure to identify the docket 
control number assigned to this action in the subject line on the first 
page of your response. You may also provide the name, date, and Federal 
Register citation.

II. What Action is the Agency Taking?

    EPA has received a pesticide petition as follows proposing the 
establishment and/or amendment of regulations for residues of a certain 
pesticide chemical in or on various food commodities under section 408 
of the Federal Food, Drug, and Comestic Act (FFDCA), 21 U.S.C. 346a. 
EPA has determined that this petition contains data or information 
regarding the elements set forth in section 408(d)(2); however, EPA has 
not fully evaluated the sufficiency of the submitted data at this time 
or whether the data supports granting of the petition. Additional data 
may be needed before EPA rules on the petition.

List of Subjects

    Environmental protection, Agricultural commodities, Feed additives, 
Food additives, Pesticides and pests, Reporting and recordkeeping 
requirements.

    Dated: May 2, 2000.
James Jones,
Director, Registration Division, Office of Pesticide Programs.

Summary of Petition

    The petitioner summary of the pesticide petition is printed below 
as required by section 408(d)(3) of the FFDCA. The summary of the 
petition

[[Page 30593]]

was prepared by the petitioner and represents the view of the 
petitioners. EPA is publishing the petition summary verbatim without 
editing it in any way. The petition summary announces the availability 
of a description of the analytical methods available to EPA for the 
detection and measurement of the pesticide chemical residues or an 
explanation of why no such method is needed.

Zeneca Ag Products

0F6092

    EPA has received a pesticide petition (0F6092) from Zeneca Ag 
Products, 1800 Concord Pike, P.O. Box 15458, Wilmington, DE, 19850-5458 
proposing, pursuant to section 408(d) of FFDCA, 21 U.S.C. 346a(d), to 
amend 40 CFR part 180.438, by establishing a tolerance for residues of 
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)-(1R,3R)-3-(2-chloro-3,3,3-trifluoroprop-1-enyl)-2, 2-
dimethylcyclopropanecarboxylate in or on the raw agricultural 
commodities (RAC) canola seed, almond hulls, and the crop groupings 
pome fruit, stone fruit and tree nuts at 0.15, 1.5, 0.3, 0.5, 0.05 
parts per million (ppm), respectively, and on the processed commodity 
apple pomace, wet at 2.5 ppm. EPA has determined that the petition 
contains data or information regarding the elements set forth in 
section 408(d)(2) of the FFDCA; however, EPA has not fully evaluated 
the sufficiency of the submitted data at this time or whether the data 
supports granting of the petition. Additional data may be needed before 
EPA rules on the petition.

A. Residue Chemistry

    1. Plant metabolism. The metabolism of lambda-cyhalothrin has been 
studied in cotton, soybean, cabbage and wheat plants. The studies show 
that the metabolism generally follows that of other pyrethroid 
insecticides. The ester linkage is cleaved to form 
cyclopropanecarboxylic acids and the corresponding phenoxybenzyl 
alcohol. Overall the studies show that unchanged lambda-cyhalothrin is 
the principal constituent of the residue on edible portions of these 
crops.
    2. Analytical method. An adequate analytical method (gas liquid 
chromatography with an electron capture detector) is available for 
enforcement purposes.
    3. Magnitude of residues. Crop field trial residue data from 
canola, pome fruit, stone fruit and tree nuts studies show that the 
proposed tolerances on these commodities will not be exceeded when 
lambda-cyhalothrin is used as directed. A market basket survey of 
residues of lambda-cyhalothrin in samples of whole milk collected 
across the contiguous United States over a period of 1 year was 
conducted during 1998-99. Nearly 80% of the 360 samples collected had 
non-detectable (0.0003 g/L) levels of lambda-cyhalothrin with 
the remaining 20% having trace levels (0.001 g/L). These 
levels are substantially less than the established tolerance for whole 
milk of 0.2 milligrams/kilograms (mg/kg).
    No increase in the dietary burden of poultry and ruminants is 
expected from use on canola, pome fruit, stone fruit, or tree nuts. 
Therefore, any secondary residues that might result in milk, meat, 
poultry, and eggs would be covered by the existing tolerances on these 
commodities.

B. Toxicological Profile

    1. Acute toxicity. Acute toxicity studies with the technical grade 
of the active ingredient lambda-cyahothrin: oral lethel dose 
(LD)50 in the rat of 79 mg/kg (males) and 56 mg/kg 
(females), dermal LD50 in the rat of 632 mg/kg (males) and 
696 mg/kg females, primary eye irritation study showed mild irritation 
and primary dermal irritation study showed no irritation.
    2. Genotoxicty. The following genotoxicity tests were all negative: 
a gene mutation assay (Ames), a mouse micronucleus assay, an in vitro 
cytogenetics assay, and a gene mutation study in mouse lymphoma cells.
    3. Reproductive and developmental toxicity. A 3-generation 
reproduction study in rats fed diets containing 0, 10, 30, and 100 ppm 
with no developmental toxicity observed at 100 ppm, the highest dose 
tested. The maternal NOAEL (no observed adverse effect level) and LOAEL 
(lowest observed adverse effect level) for the study are established at 
30 (1.5 mg/kg/day) and 100 ppm (5 mg/kg/day), respectively, based upon 
decreased parental body weight gain. The reproductive NOAEL and LOAEL 
are established at 30 (1.5 mg/kg/day) and 100 ppm (5 mg/kg/day), 
respectively, based on decreased pup weight gain during weaning.
    A developmental toxicity study in rats given gavage doses of 0, 5, 
10, and 15 mg/kg/day with no developmental toxicity observed under the 
conditions of the study. The developmental NOAEL is greater than 15 mg/
kg/day, the highest dose tested. The maternal NOAEL and LOAEL are 
established at 10 and 15 mg/kg/day, respectively, based on reduced body 
weight gain.
    A developmental toxicity study in rabbits given gavage doses of 0, 
3, 10, and 30 mg/kg/day with no developmental toxicity observed under 
the conditions of the study. The maternal NOAEL and LOAEL are 
established at 10 and 30 mg/kg/day, respectively based on decreased 
body weight gain. The developmental NOAEL is greater than 30 mg/kg/day, 
the highest dose tested.
    4. Subchronic toxicity. A 90-day feeding study in rats fed doses of 
0, 10, 50 and 250 ppm with a NOAEL of 50 ppm and a LOAEL of 250 ppm 
based on body weight gain reduction.
    A study where lambda-cyhalothrin in olive oil was applied to the 
skin of rats for 21 successive days at dose rates of 1, 10, or 100 
(reduced to 50 after 2-3 applications) mg/kg/day. A NOAEL of 10 mg/kg/
day is based on clinical signs of slight general toxicity at 50 mg/kg/
day.
    5. Chronic toxicity. A 12-month feeding study in dogs fed dose (by 
capsule) levels of 0, 0.1, 0.5, 3.5 mg/kg/day with a NOAEL of 0.1 mg/
kg/day. The LOAEL for this study is established at 0.5 mg/kg/day based 
upon clinical signs of neurotoxicity.
    A 24-month chronic feeding/carcinogenicity study with rats fed 
diets containing 0, 10, 50, and 250 ppm. The NOAEL was established at 
50 ppm and LOAEL at 250 ppm based on reduced body weight gain. There 
were no carcinogenic effects observed under the conditions of the 
study.
    A carcinogenicity study in mice fed dose levels of 0, 20, 100, or 
500 ppm (0, 3, 15, or 75 mg/kg/day) in the diet for 2 years. A systemic 
NOAEL was established at 100 ppm and systemic LOAEL at 500 ppm based on 
decreased body weight gain in males throughout the study at 500 ppm. 
The Agency has classified lambda-cyhalothrin as a Group D carcinogen 
(not classifiable due to an equivocal finding in this study). It is 
Zeneca's position that no treatment-related carcinogenic effects were 
observed under the conditions of the study.
    6. Animal metabolism. Metabolism studies in rats demonstrated that 
distribution patterns and excretion rates

[[Page 30594]]

in multiple oral dose studies are similar to single-dose studies. 
Accumulation of unchanged compound in fat upon chronic administration 
with slow elimination was observed. Otherwise, lambda-cyhalothrin was 
rapidly metabolized and excreted. The metabolism of lambda-cyhalothrin 
in livestock has been studied in the goat, chicken, and cow. Unchanged 
lambda-cyhalothrin is the major residue component of toxicological 
concern in meat and milk.
    Human metabolism of lambda-cyhalothrin was assessed by 
administering 5 mg lambda-cyhalothrin orally to six male volunteers 
(average dose was 0.06 mg/kg) and dermally at 20 mg/800 
centimeters2 to five volunteers. No adverse effects were 
noted in the individuals given an oral dose, and only mild signs of 
parasthesia were noted in individuals receiving a dermal dose. 
Absorption by these two routes of exposure were determined by analysis 
of urinary metabolites. An average amount of 59% of the oral dose was 
absorbed. Dermal absorption was extremely low, and estimated to be 
0.12% (range 0.04-0.19%).
    7. Metabolite toxicology. The Agency has previously determined that 
the metabolites of lambda-cyhalothrin are not of toxicological concern 
and need not be included in the tolerance expression. Given this 
determination, it is concluded that there is no need to discuss 
metabolite toxicity.
    8. Endocrine disruption. EPA is required to develop a screening 
program to determine whether certain substances (including all 
pesticides and inerts) ``may have an effect in humans that is similar 
to an effect produced by a naturally occurring estrogen, or such other 
endocrine effect * * *'' The Agency is currently working with 
interested stakeholders, including other government agencies, public 
interest groups, industry and research scientists in developing a 
screening and testing program and a priority setting scheme to 
implement this program. Congress has allowed 3 years from the passage 
of FQPA (August 3, 1999) to implement this program. At that time, EPA 
may require further testing of this active ingredient and end use 
products for endocrine disrupter effects.

C. Aggregate Exposure

    1. Dietary exposure. For the purposes of assessing the potential 
chronic dietary exposure for all existing and pending tolerances for 
lambda-cyhalothrin, Zeneca has utilized available information on 
anticipated residues (FDA monitoring data, average field trial residues 
and processing data) and percent crop treated. For the acute dietary 
assessment, a Monte Carlo method was used to estimate exposure.
    i. Food --a. Acute dietary exposure. An acute dietary exposure 
assessment was made using the dietary exposure evaluation model (DEEM) 
computer software (Novigen Sciences Inc.) and the USDA Continuing 
Surveys of Individual Intakes (CSFII) 1994-96. Acute dietary exposure 
was based on all crops with tolerances for lambda-cyhalothrin 
established at 40 CFR 180.438 together with crops in this petition, 
canola, and the crop groupings pome fruit, stone fruit and tree nuts. 
Anticipated residues were estimated from field trial data and from the 
lambda-cyhalothrin national milk survey together with estimates of 
percent crop treated for each crop. The predicted acute exposure for 
the U.S. population was 0.001269 mg/kg/body weight/day (mg/kg/bwt/day). 
The population subgroup with the highest predicted level of acute 
exposure was non-nursing infants (1 year old) with an exposure of 
0.003599 mg/kg/bwt/day (99.9th percentile). Based on an acute NOAEL of 
0.5 mg/kg/bwt/day from a 1-year dog feeding study, and a 100-fold 
safety factor, the acute reference dose (aRfD) is 0.005 mg/kg/bwt/day. 
For the U.S. population the predicted exposure is equivalent to 25% of 
the aRfD. For the population subgroup non-nursing infants (1 year old) 
the exposure is equivalent to 72% of the aRfD. Because the predicted 
exposures, expressed as the percentages of the aRfD, are well below 
100%, there is reasonable certainty that no acute effects would result 
from the dietary exposure to lambda-cyhalothrin.
    b. Chronic dietary exposure. A chronic dietary exposure assessment 
was made using the DEEM computer software (Novigen Sciences Inc.). 
Chronic dietary exposure was based on all crops with tolerances for 
lambda-cyhalothrin established at 40 CFR 180.438 together with crops in 
this petition, canola, and the crop groupings pome fruit, stone fruit 
and tree nuts. Anticipated residues were estimated from field trial 
data and from the lambda-cyhalothrin national milk survey together with 
estimates of percent crop treated for each crop. The predicted chronic 
exposure for the U.S. population was 0.000062 mg/kg/bwt/day. The 
population subgroup with the highest predicted level of chronic 
exposure was non-nursing infants with an exposure of 0.000132 mg/kg/
bwt/day. Based on a chronic NOAEL of 0.1 mg/kg/bwt/day from a 1-year 
dog feeding study, and a 100-fold safety factor, the chronic reference 
dose (cRfD) is 0.001 mg/kg/bwt/day. For the U.S. population the 
predicted exposure is equivalent to 6.2% of the cRfD. For the 
population subgroup non-nursing infants the exposure is equivalent to 
13.2% of the cRfD. Because the predicted exposures, expressed as the 
percentages of the aRfD, are well below 100%, there is reasonable 
certainty that no chronic effects would result from the dietary 
exposure to lambda-cyhalothrin.
    ii. Drinking water. Laboratory and field data have demonstrated 
that lambda-cyhalothrin and its degradates are immobile in soil and 
will not leach into ground water. Surface water estimates were made by 
EPA using the GENEEC model (Tier I). The predicted peak, average and 
annual values (56 days) are, respectively, 0.095 parts per billion 
(ppb), 0.003 ppb and 0.003 ppb. EPA uses drinking water levels of 
comparison (DWLOCs) as a surrogate measure to capture risk associated 
with exposure to pesticides in drinking water. A DWLOC is the 
concentration of a pesticide in drinking water that would be acceptable 
as an upper limit in light of total aggregate exposure to that 
pesticide from food, water, and residential uses. A DWLOC will vary 
depending on the residue level in foods, the toxicity endpoint and with 
drinking water consumption patterns and body weights for specific 
subpopulations. The acute DWLOC for lambda-cyhalothrin was calculated 
for the subpopulation of concern, non-nursing infants (1 year old), to 
be 14 ppb. The chronic DWLOC was calculated for this subpopulation to 
be 9 ppb. The predicted maximum concentration of lambda-cyhalothrin in 
drinking water is 0.095 ppb which is much lower than the acute DWLOC. 
Therefore one can conclude with reasonable certainty that residues of 
lambda-cyhalothrin do not contribute significantly to the aggregate 
acute human health risk. The chronic DWLOC for the most sensitive 
subpopulation, non-nursing infants (1 year old), is 9 ppb. This DWLOC 
is substantially higher than the predicted average concentration of 
lambda-cyhalothrin in surface water of 0.003 ppb. Therefore one can 
conclude with reasonable certainty that residues of lambda-cyhalothrin 
do not contribute significantly to the aggregate chronic human health 
risk.
    2. Non-dietary exposure. Other potential sources of exposure are 
from non-occupational sources such as structural pest control and 
ornamental plant and lawn use of lambda-cyhalothrin. A risk assessment 
was performed by EPA published in the Federal Register January 29, 1999 
(64 FR 4584) (FRL-6056-2), for post application activities on lawns 
treated

[[Page 30595]]

with lambda-cyhalothrin which is considered to be a worse case estimate 
of exposure from residential uses. Results from EPA's short-term 
exposure and risk assessments showed that the oral MOE (margin of 
exposure) for infants and children was 3,500, the dermal MOEs were 1.5 
million for the U.S. population and 7,810 for infants and children, and 
the inhalation MOEs were 15,000 for the U.S. population and 4,800 for 
infants and children. For intermediate-term exposure and risk 
assessments, EPA concluded the oral MOEs for infants and children was 
700, the dermal MOEs were 1.5 million for the U.S. population and 7,810 
for infants and children, and the inhalation MOEs were 15,000 for the 
U.S. population and 4,800 for infants and children. EPA concludes that 
there is a reasonable certainty of no harm for MOEs of 100 or greater. 
Therefore, the non-dietary and overall aggregate risk assessments for 
lambda-cyhalothrin clearly indicates a reasonable certainty of no harm.

D. Cumulative Effects

    Zeneca Ag Products will submit information for EPA to consider 
concerning potential cumulative effects of lambda-cyhalothrin 
consistent with the schedule established by EPA in the Federal Register 
of August 4, 1997 (62 FR 42020) (FRL-5734-6), and other EPA 
publications pursuant to the Food Quality Protection Act. At this time, 
Zeneca cannot make a determination based on available and reliable 
information that lambda-cyhalothrin and other substances that may have 
a common mechanism of toxicity would have cumulative effects. Therefore 
for purposes of this request it is appropriate only to consider the 
potential risks of lambda-cyhalothrin in an aggregate exposure 
assessment.

E. Safety Determination

    1. U.S. population. Based on the completeness and reliability of 
the lambda-cyhalothrin toxicology data base and using the conservative 
aggregate exposure assumptions presented earlier, it is concluded that 
lambda-cyhalothrin products may be used with a reasonable certainty of 
no harm relative to exposures from food and drinking water. A chronic 
dietary exposure and risk assessment has been performed for lambda-
cyhalothrin using EPA's cRfD of 0.001 mg/kg/bwt/day. Available 
information on anticipated residues, monitoring data and percent crop 
treated was incorporated into the analysis to estimate the Anticipated 
Residue Contribution (ARC). The ARC is generally considered a more 
realistic estimate than an estimate based on tolerance level residues. 
The ARC from established tolerances and the current and pending actions 
are estimated to be 0.000062 mg/kg/bwt/day and utilize 6.2% of the 
cRfD. An acute dietary exposure and risk assessment has been performed 
for lambda-cyhalothrin using EPA's aRfD of 0.005 mg/kg/bwt/day. The ARC 
from established tolerances and the current and pending actions are 
estimated to be 0.001269 and utilize 25% of the aRfD. The acute and 
chonic DWLOC for lambda-cyhalothrin for the U.S. population are 131 ppb 
and 33 ppb, respectively. The maximum concentrations in drinking water 
predicted by EPA are substantially lower than either the acute or 
chronic DWLOC. Therefore, one can conclude with reasonable certainty 
that residues of lambda-cyhalothrin in drinking water would not 
contribute significantly to the aggregate acute or chronic human health 
risk. In conclusion, there is a reasonable certainty of no harm to the 
general population resulting from either acute or chronic aggregate 
exposure to lambda-cyhalothrin.
    2. Infants and children. FFDCA section 408 provides that EPA shall 
apply an additional ten-fold margin of safety for infants and children 
in the case of threshold effects to account for prenatal and postnatal 
toxicity and the completeness of the data base unless EPA determines 
that a different margin of safety will be safe for infants and 
children. EPA generally defines the level of appreciable risk as 
exposure that is greater than 1/100 of the NOAEL in the animal study 
appropriate to the particular risk assessment. This hundred-fold 
uncertainty (safety) factor/margin of exposure is designed to account 
for combined interspecies and intraspecies variability. EPA believes 
that reliable data support using the standard hundred-fold margin/
factor and not the additional tenfold margin/factor when EPA has a 
complete data base under existing guidelines and when the severity of 
the effect in infants and children or the potency or unusual toxic 
properties of a compound do not raise concerns regarding the adequacy 
of the standard margin/factor.
    In assessing the potential for additional sensitivity of infants 
and children to residues of lambda-cyhalothrin, EPA considered the data 
from oral developmental toxicity studies in the rat and rabbit, as well 
as data from a multi-generation reproduction study in the rat. The 
developmental toxicity studies are designed to evaluate adverse effects 
in the developing organism resulting from pesticide exposure during 
prenatal development in the mothers. Reproduction studies provide 
information relating to effects from exposure to the pesticide on the 
reproductive capability of mating animals and data on systemic 
toxicity.
    3. Prenatal effects. A developmental toxicity study in rats given 
gavage doses of 0, 5, 10, and 15 mg/kg/day with no developmental 
toxicity observed under the conditions of the study. The developmental 
NOAEL is greater than 15 mg/kg/day, the highest dose tested. The 
maternal NOAEL and LOAEL are established at 10 and 15 mg/kg/day, 
respectively, based on reduced body weight gain.
    A developmental toxicity study in rabbits given gavage doses of 0, 
3, 10, and 30 mg/kg/day with no developmental toxicity observed under 
the conditions of the study. The maternal NOAEL and LOAEL are 
established at 10 and 30 mg/kg/day, respectively based on decreased 
body weight gain. The developmental NOAEL is greater than 30 mg/kg/day, 
the highest dose tested.
    4. Postnatal effects. A 3-generation reproduction study in rats fed 
diets containing 0, 10, 30, and 100 ppm with no developmental toxicity 
observed at 100 ppm, the highest dose tested. The maternal NOAEL and 
LOAEL for the study are established at 30 (1.5 mg/kg/day) and 100 ppm 
(5 mg/kg/day), respectively, based upon decreased parental body weight 
gain. The reproductive NOAEL and LOAEL are established at 30 (1.5 mg/
kg/day) and 100 ppm (5 mg/kg/day), respectively, based on decreased pup 
weight gain during weaning.
    EPA have concluded in its 1997 review of lambda-cyhalothrin that 
the toxicity endpoints from the data on developmental and reproductive 
toxicity tests do not indicate any increased prenatal or postnatal 
sensitivity. Therefore, EPA concluded that reliable data support use of 
a hundred fold safety factor and that an additional tenfold safety 
factor is not needed.
    Based on this information, the ARC for children aged 1 to 6 years 
old, and non-nursing infants (subgroups most highly exposed) utilizes 
0.000127 mg/kg/bwt/day (12.7% of the cRfD) and 0.000132 mg/kg/bwt/day 
(13.2% of the cRfD), respectively. Generally speaking, the Agency has 
no cause for concern if the anticipated residues contribution for all 
published and proposed tolerances is less than the 100% of the cRfD.
    For the acute dietary assessment the ARC for children aged 1 to 6 
years old, and non-nursing infants (subgroups most highly exposed) 
utilizes 0.002363 mg/kg/bwt/day (47.3% of the aRfD) and

[[Page 30596]]

0.003599 mg/kg/bwt/day (72% of the aRfD), respectively. Generally 
speaking, the Agency has no cause for concern if the anticipated 
residues contribution for all published and proposed tolerances is less 
than the 100% of the aRfD. The acute and chonic DWLOC for lambda-
cyhalothrin for non-nursing infants are 14 ppb and 9 ppb, respectively. 
The maximum concentrations in drinking water predicted by EPA are 
substantially lower than either the acute or chronic DWLOC. Based on 
these exposure estimates it may be concluded that there is a reasonable 
certainty that no harm will result to infants and children from 
aggregate exposures to lambda-cyhalothrin.

F. International Tolerances

    There are Codex maximum residue levels (MRL) established or pending 
for residues of cyhalothrin, as the sum of all isomers, in or on the 
following crops and commoditites.

 
------------------------------------------------------------------------
                   Crop                              MRL (mg/kg)
------------------------------------------------------------------------
Apricots..................................  0.2
Cabbage, head.............................  0.2
Cherries..................................  0.2
Cotton seed...............................  0.02
Cotton seed, oil..........................  0.02
Oil seed (including rapeseed oil).........  0.02
Peaches...................................  0.2
Plums.....................................  0.1
Pome fruit................................  0.1
Potatoes..................................  0.02
Tree nuts (shelled and unshelled).........  0.05
------------------------------------------------------------------------

    Canadian MRLs of 0.1 ppm for pome fruit, stone fruit and canola are 
established in Canada for lambda-cyhalothrin based on the ``negligble'' 
residue clause of Canadian Food & Drug Act Regulations (B.15.002(1)).
[FR Doc. 00-11871 Filed 5-11-00; 8:45 am]
BILLING CODE 6560-50-F