[Federal Register Volume 66, Number 216 (Wednesday, November 7, 2001)]
[Notices]
[Pages 56298-56305]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-27598]


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ENVIRONMENTAL PROTECTION AGENCY

[PF-917A; FRL-6808-5]


Notice of Filing a Pesticide Petition to Establish a Tolerance 
for a Certain Pesticide Chemical 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 a 
certain pesticide chemical in or on various food commodities.

[[Page 56299]]


DATES: Comments, identified by docket control number PF-917A, must be 
received on or before December 7, 2001.

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-917A in the subject line on the first page of your 
response.

FOR FURTHER INFORMATION CONTACT:  By mail: George LaRocca, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; 
telephone number: (703) 305-6100; 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
                                  311                 Food manufacturing
  ..............................  32532.............  Pesticide
                                                       manufacturing
------------------------------------------------------------------------

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

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

    1. Electronically. You may obtain electronic copies of this 
document, and certain other related documents that might be available 
electronically, from the EPA Internet Home Page at http://www.epa.gov/. 
To access this document, on the Home Page select ``Laws and 
Regulations,'' ``Regulations and Proposed Rules,'' 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-917A. 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, 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-917A 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, 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, Crystal Mall #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-917A. 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.

[[Page 56300]]

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 Cosmetic 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 support 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: October 27, 2001.

Peter Caulkins,
Acting 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 was prepared by the petitioner and represents the view of the 
petitioner. 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.

Aventis CropScience

PP 0F 6080

    EPA published an initial filing of the pesticide petition (PP 0F 
6080) in the Federal Register of February 17, 2000 (65 FR 8143) (FRL-
6490-2). This notice announces the filing of the revised pesticide 
petition proposing the establishment of regulations for residues of 
deltamethrin, a pesticide chemical, in or on various food commodities. 
The revised petition is for changes made for the proposed tolerances 
for deltamethrin in/on almond hull, three crop subgroups and rapeseed 
and to include the proposed import tolerances for two tropical fruits 
as petitioned through the Minor Crop Pest Management program (IR-4).
    EPA has received a pesticide petition (PP 0F 6080) from Aventis 
CropScience, P.O. Box 12014, 2 T.W. Alexander Drive, Research Triangle 
Park, N.C. 27709 proposing, pursuant to section 408(d) of the FFDCA, 21 
U.S.C. 346a(d), to amend 40 CFR part 180 by establishing a tolerance 
for residues of deltamethrin in or on the raw agricultural commodities 
bulb vegetables, cucurbit vegetables, fruiting vegetables, head and 
brassica vegetables and mustard greens, leafy vegetables, root 
vegetables (except sugarbeet), tuberous and corm vegetables, carambola 
and litchi fruits (import only), pome fruits, stone fruits, tree nuts, 
ruminant and poultry commodities, milk, milkfat, eggs, canola and 
rapeseed, field corn, sorghum, soybeans, sunflowers and wheat grain and 
grain dust (post harvest). Based on the fact that tralomethrin, another 
synthetic pyrethroid insecticide, is rapidly metabolized in plants and 
animals to deltamethrin, and the toxicological profile of the two 
compounds is similar, it is appropriate to consider a combined exposure 
assessment for tralomethrin and deltamethrin. The proposed tolerances 
range from 0.02 to 7.0 parts per million (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 support granting of the petition. Additional data may be 
needed before EPA rules on the petition.

A. Residue Chemistry

    1. Plant metabolism. Deltamethrin metabolism studies in tomatoes, 
corn, apples, and cotton demonstrate the same metabolic pathway. 
Furthermore, plant metabolism studies have been conducted following 
application of tralomethrin in cotton, corn, cabbage, and tomatoes. 
These studies have demonstrated that the metabolism of tralomethrin 
involves debromination to deltamethrin and its isomers. Thus, a similar 
metabolic pathway has been shown to occur in a variety of crops 
following either direct application of deltamethrin (cotton, corn, 
apples, and tomatoes) or in-plant formation of deltamethrin via 
debromination of applied tralomethrin (tomatoes, cotton, corn, and 
cabbage). As a result of this substantial information base, it is 
concluded that the residues of toxicological concern in/on growing 
crops following application of tralomethrin or deltamethrin are 
tralomethrin, cis-deltamethrin, and its isomers, trans-deltamethrin and 
alpha-R-deltamethrin.
    2. Analytical method. Analytical methods for determining residues 
of tralomethrin and deltamethrin in various commodities for which 
registrations have been approved, or are being sought, have been 
submitted to the Agency. These methods, are based on gas chromatography 
(GLC) equipped with an electron capture detector (ECD) and a DB-1 (or 
equivalent) capillary column, and are used for the determination of 
tralomethrin, cis-deltamethrin, trans-deltamethrin, and alpha-R-
deltamethrin in various raw agricultural, animal-derived, and processed 
commodities. These methods were independently validated and are 
appropriate for the determination of residues of tralomethrin and 
deltamethrin in various food and feed commodities after application of 
these ingredients to target growing crops, and after use in food/feed 
handling establishments.
    3. Magnitude of residues. Residues of tralomethrin, deltamethrin, 
and its metabolites are not expected to exceed the established and/or 
proposed tolerance levels as a result of the use of these active 
ingredients on target crops, or at target sites.

B. Toxicological Profile

    1. Acute toxicity. The acute oral LD50 values of 
deltamethrin in the rat were 66.7 milligrams/kilogram (mg/kg) for males 
and 86 mg/kg for females, and for tralomethrin 99 mg/kg for males and 
157 mg/kg for females when administered in sesame oil. The oral 
LD50 for deltamethrin when administered in aqueous methyl 
cellulose was greater than 5,000 mg/kg for both sexes. The dermal 
LD50 in rabbits was greater than 2,000 mg/kg for both 
materials. Inhalation 4-hour LC50 values in the rat were 2.2 
mg/L for deltamethrin and greater than 0.286 mg/L for tralomethrin.
    2. Genotoxicity. No indication of genotoxicity was noted in a 
battery of in vivo and in vitro studies conducted with either 
deltamethrin or tralomethrin.
    3. Reproductive and developmental toxicity--i. Deltamethrin. A rat 
development toxicity study conducted with deltamethrin indicated a 
maternal no observed adverse effect level (NOAEL) of 3.3 mg/kg/day 
based on clinical observations, decreased weight gain and mortality. 
The developmental NOAEL was 11 mg/kg/day highest dose tested (HDT). In 
a rabbit development toxicity study with deltamethrin, the maternal 
NOAEL was considered to be 10 mg/kg/day based on decreased defecation 
at 25 and 100 mg/kg/day, and mortality at 100 mg/kg/day. The 
developmental NOAEL was considered

[[Page 56301]]

to be 25 mg/kg/day based on retarded ossification of the public and 
tail bones at 100 mg/kg (HDT).
    A 3-generation rat reproduction study and a more recent, 2-
generation rat reproduction study with deltamethrin indicated the NOAEL 
for both parents and offspring was 80 ppm (4-12 mg/kg/day for adults 
and 18-44 mg/kg/day for offspring) based on clinical signs of toxicity, 
reduced weight gain and mortality at 320 ppm (HDT).
    ii. Tralomethrin. In a rat developmental toxicity study with 
tralomethrin, the NOAEL for maternal and developmental toxicity was 
judged to be greater than or equal to 18 mg/kg/day (HDT).
    No evidence of developmental toxicity was observed in either of two 
rabbit developmental toxicity studies conducted with tralomethrin. In 
one study, the maternal NOAEL was 12.5 mg/kg/day based on mortality, 
while the developmental NOAEL was judged to be greater than or equal to 
25 mg/kg/day (HDT). In the second study, the maternal NOAEL was 8 mg/
kg/day based on body weight effects while the developmental NOAEL was 
32 mg/kg/day (HDT).
    In a 2-generation reproduction study with tralomethrin in rats, the 
parental NOAEL was 0.75 mg/kg/day based on body weight deficits while 
the NOAEL for offspring was 3.0 mg/kg/day, also based on body weight 
deficits.
    4. Subchronic toxicity--i. Deltamethrin. A 90-day rat oral toxicity 
study was conducted with deltamethrin which was administered by gavage. 
The NOAEL was judged to be 1.0 mg/kg/day based on reduced body weight 
gain and slight hypersensitivity. In more recent 90-day rat dietary 
study with deltamethrin, the NOAEL was judged to be 300 ppm (23.9 mg/
kg/day for males, 30.5 mg/kg/day for females) based on uncoordinated 
movement, unsteady gait, tremors, increased sensitivity to sound, 
shakes and spasmodic convulsions. The difference in the NOAELs between 
the two studies is attributed to the different routes of exposure 
(gavage in oil vs. administered in diet).
    A 12-week study was conducted with deltamethrin in mice. The NOAEL 
was 300 ppm (61.5 mg/kg/day in males and 77.0 mg/kg/day in females) 
based on chronic contractions, convulsions, poor condition, decreased 
weight gain and mortality.
    Two 13-week dog studies were conducted with deltamethrin. In the 
first study, beagle dogs were administered deltamethrin by capsule 
using PEG 200 as a vehicle. The NOAEL for this study was 1 mg/kg/day 
based on tremors, unsteadiness, jerking movements, salivation, 
vomiting, liquid feces and/or dilation of the pupils. In the second 
study, deltamethrin was administered by capsule without a vehicle to 
beagle dogs. The NOAEL for this study was 10 mg/kg/day based on 
unsteady gait, tremors, head shaking, vomiting and salivation. The 
difference in toxicity between the two studies is attributed to the 
enhanced absorption resulting from the use of PEG 200 as a vehicle in 
the first study.
    A 21-day dermal toxicity study was conducted with deltamethrin in 
rats. The NOAEL for systemic toxicity was determined to be 1,000 mg/kg/
day.
    In a subchronic inhalation study, rats were exposed to aerosolized 
deltamethrin for 6 hours per day, 5 days per week, for a total of 14 
days over 3 weeks. Based on slightly decreased body weights and 
neurological effects at higher dose levels, it was concluded that 3 g/L 
was the no observable effect concentration for systemic effects in this 
study.
    ii. Tralomethrin. Tralomethrin was administered by gavage in corn 
oil to rats for 13 weeks. Based on mortality, decreased activity and 
motor control, soft stools, labored breathing and significantly lower 
absolute and relative mean liver weights, the NOAEL was considered to 
be 1 mg/kg/day.
    Tralomethrin was administered by capsule to beagle dogs for 13 
weeks. The NOAEL for this study was 1.0 mg/kg/day based on refusal of 
milk supplement, tremors, exaggerated patellar response, unsteadiness 
and uncoordinated movement.
    A 21-day dermal toxicity study was conducted with tralomethrin on 
rats. No systemic effects were observed; therefore, the systemic NOAEL 
for this study was 1,000 mg/kg/day.
    5. Chronic toxicity--i. Deltamethrin. Deltamethrin was administered 
in the diet to beagle dogs for 2 years. No treatment-related effects 
were observed and the NOAEL was judged to be 40 ppm (1.1 mg/kg/day). In 
a more recent study, deltamethrin was administered by capsule (without 
a vehicle) to beagle dogs for 1-year. The NOAEL in this study was 
considered to be 1 mg/kg/day based on clinical signs, decreased food 
consumption and changes in several hematology and blood chemistry 
parameters.
    Two rat chronic toxicity/oncogenicity studies were conducted with 
deltamethrin. In the first study, the test substance was administered 
via the diet to rats for 2 years. The NOAEL for this study was 20 ppm 
(1 mg/kg/day) based on slightly decreased weight gain. In a more recent 
study, deltamethrin was administered to rats in the diet for 2 years. 
The NOAEL for this study was considered to be 25 ppm (1.1 and 1.5 mg/
kg/day for males and females, respectively) based on neurological 
signs, weight gain effects and increased incidence and severity of 
eosinophilic hepatocytes and/or ballon cells. No evidence of 
carcinogenicity was noted in either study.
    Two mouse oncogenicity studies were conducted with deltamethrin. In 
the first study, deltamethrin was administered in the diet for 2 years. 
No adverse effects were observed and the NOAEL was judged to be 100 ppm 
(12 and 15 mg/kg/day, respectively, for males and females). In a more 
recent study, deltamethrin was administered in the diet to mice for 97 
weeks. The NOAEL was considered to be 1,000 ppm (15.7 and 19.6 mg/kg/
day) based on a higher incidence of poor physical condition and a 
slight transient weight reduction. There was no evidence of 
oncogenicity in either study.
    ii. Tralomethrin. Tralomethrin was administered to beagle dogs by 
capsule for 1-year at initial dosages of 0, 0.75, 3.0 and 10.0 mg/kg/
day. Due to trembling, ataxia, prostration and convulsions, the high 
dosage was lowered to 8 mg/kg/day at study week 4 and lowered again to 
6 mg/kg/day on study week 14. On the fourteenth week of study, the 0.75 
mg/kg/day dosage was raised to 1.0 mg/kg/day. Based on body weight 
changes, convulsions, tremors, ataxia and salivation, the NOAEL for 
this study was considered to be 1 mg/kg/day.
    Tralomethrin was administered by gavage to rats for 24 months. The 
NOAEL for this study was 0.75 mg/kg/day based on salivation, 
uncoordinated movement, inability to support weight on limbs and 
decreased body weight parameters. No evidence of carcinogenicity was 
observed.
    A 2-year mouse oncogenicity study was conducted with tralomethrin 
administered by gavage. The NOAEL was judged to be 0.75 mg/kg/day based 
on higher incidences of dermatitis and mortality, salivation, 
uncoordinated involuntary movements and aggressiveness. No evidence of 
oncogenicity was observed.
    6. Animal metabolism--i. Deltamethrin. The absorption of 
deltamethrin appears to be highly dependent upon the route and vehicle 
of administration. Once absorbed, deltamethrin is rapidly and 
extensively metabolized and excreted, primarily within the first 48 
hours.
    ii. Tralomethrin. Tralomethrin is rapidly metabolized to 
deltamethrin after debromination. The metabolic

[[Page 56302]]

pattern of the in vivo debrominated tralomethrin is exactly the same as 
that of the metabolic pattern of deltamethrin.
    7. Endocrine disruption. No special studies have been conducted to 
investigate the potential of deltamethrin or tralomethrin to induce 
estrogenic or other endocrine effects. However, the standard battery of 
required toxicity studies has been completed. These studies include an 
evaluation of the potential effects on reproduction and development, 
and an evaluation of the pathology of the endocrine organs following 
repeated or long-term exposure. These studies are generally considered 
to be sufficient to detect any endocrine effects, yet no such effects 
were detected. Thus, the potential for deltamethrin or tralomethrin to 
produce any significant endocrine effects is considered to be minimal.
    8. Neurotoxicity. Acute delayed neurotoxicity studies in hens were 
conducted for both deltamethrin and tralomethrin. In both cases, the 
study results were negative indicating that neither material causes 
delayed neurotoxicity.
    In an acute neurotoxicity study with deltamethrin in rats, 
mortality and numerous clinical signs of neurotoxicity (including 
altered gait, salivation, tremors, convulsions, writhing, and reduced 
grip strength) were noted after a single oral administration of a dose 
of 50 mg/kg. In addition, potential effects (limited to a single male 
and female) were observed at a dose level of 15 mg/kg. Therefore, the 
NOAEL for this study was 5 mg/kg.
    In a subchronic neurotoxicity study with deltamethrin in rats, 
mortality, decreased weight gain and numerous clinical signs of 
neurotoxicity (including writhing, hind limb splay, convulsions, 
lurching, and reduced grip strength) were noted after daily dietary 
administration for 13 consecutive weeks at 800 ppm. The NOAEL for 
systemic toxicity and neurotoxicity in this study was found to be 200 
ppm (14 and 16 mg/kg/day for males and females, respectively).

C. Aggregate Exposure

    Based on the fact that tralomethrin is rapidly metabolized in 
plants and animals to deltamethrin, and the toxicological profile of 
the two compounds is similar, it is appropriate to consider combined 
exposure assessments for tralomethrin and deltamethrin. Deltamethrin 
and tralomethrin are broad spectrum insecticides used to control pests 
of crops, ornamental plants and turf, and domestic indoor and outdoor 
(including dog collars and direct application to livestock), 
commercial, and industrial food use areas. Thus, aggregate non-
occupational exposure could include exposures resulting from non-food 
uses in addition to consumption of potential residues in food and 
water. Exposure via drinking water is expected to be negligible since 
deltamethrin binds tightly to soil and rapidly degrades in water.
    1. Dietary exposure--i. Food. Food tolerances have been established 
for residues of tralomethrin and/or deltamethrin and its metabolites in 
or on a variety of raw agricultural commodities. These tolerances, in 
support of registrations, currently exist for residues of tralomethrin 
on broccoli, cottonseed, head lettuce, leaf lettuce, soybeans, 
sunflower seed, and cottonseed oil. Also, tolerances in support of 
registrations currently exist for deltamethrin on cottonseed and 
cottonseed oil. Additionally, tolerances have been established for 
tralomethrin to support its use in food/feed handling establishments, 
and for deltamethrin on tomatoes and concentrated tomato products to 
support the importation of tomato commodities treated with 
deltamethrin. Further, a food/feed handling establishment tolerance has 
recently been established for deltamethrin. Additional tolerances are 
being proposed for deltamethrin in the subject pesticide tolerance 
petition. Potential acute exposures from these relevant food 
commodities were estimated using a Tier 3 acute dietary risk assessment 
(Monte Carlo Analysis) following EPA guidance. Potential chronic 
exposures from food commodities under the established food and feed 
additive tolerances for deltamethrin and tralomethrin, plus the 
tolerances for deltamethrin associated with use in food/feed handling 
areas, and the tolerances proposed in this petition for deltamethrin, 
were estimated using NOVIGEN's DEEM (Dietary Exposure Evaluation 
Model). This chronic risk assessment was conducted using anticipated 
residues based on field trial or monitoring data, percent crop treated, 
and percent food handling establishments treated.
    ii. Drinking water. USEPA's Standard Operating Procedure (SOP) for 
Drinking Water Exposure and Risk Assessments was used to perform the 
drinking water analysis for deltamethrin. The SOP compares a calculated 
drinking water level of comparison (DWLOC) value to the drinking water 
estimated concentration (DWEC) value. The DWEC value results from 
either the monitoring data residues and modeled water residues. If the 
DWLOC value exceeds the DWEC value then there is reasonable certainty 
that no harm will result from aggregate exposure.
    The calculated drinking water levels of comparison (DWLOC) for 
short-term exposure for all adults, children 1-6 and infants were 
estimated to be 1,784 parts per billion (ppb), 926 ppb and 555 ppb, 
respectively. All of these DWLOC values exceed the short-term modeled 
deltamethrin water residue of 0.063 ppb. The calculated DWLOC for 
chronic exposure for all adults, children 1-6 and infants were 
estimated to be 355 ppb, 185 ppb and 112 ppb, respectively. All of 
these DWLOC values exceed the chronic modeled deltamethrin water 
residue of 0.004 ppb. Therefore, there is reasonable certainty that no 
harm will result from water exposure to deltamethrin residues.
    2. Non-dietary exposure. As noted above, deltamethrin and 
tralomethrin are broad spectrum insecticides registered for use on a 
variety of food and feed commodities. Additionally, registrations are 
held for non-agricultural applications including turf and lawn care 
treatments, broadcast carpet treatments (professional use only), indoor 
fogger, spot, crack and crevice treatments, dog collars, insect baits, 
lawn and garden sprays and indoor and outdoor residential, industrial 
and institutional sites including those for food/feed handling 
establishments.
    To evaluate non-dietary exposure, the ``flea infestation control'' 
scenario was chosen to represent a plausible but worst case non-dietary 
(indoor and outdoor) non-occupational exposure. This scenario provides 
a situation where deltamethrin and/or tralomethrin are commonly used 
and can be used concurrently for a multitude of uses, e.g., spot and/or 
broadcast treatment of infested indoor surfaces such as carpets and 
rugs, treatment of pets and treatment of the lawn. This hypothetical 
situation provides a very conservative, upper bound estimate of 
potential non-dietary exposures. Consequently, if health risks are 
acceptable under these conditions, the potential risks associated with 
other more likely scenarios would also be acceptable.
    Because tralomethrin is rapidly metabolized to deltamethrin, and 
the toxicology profiles of deltamethrin and tralomethrin are virtually 
identical, an aggregate (non-dietary + chronic dietary) exposure/risk 
assessment was conducted for the combination of both active 
ingredients. The total exposure to both materials was expressed as 
``deltamethrin equivalents'' and this was compared to the toxicology 
endpoints identified for deltamethrin.

[[Page 56303]]

D. Cumulative Effects

    When considering a tolerance, the Agency must consider ``available 
information'' concerning the cumulative effects of a particular 
pesticide's residues and ``other substances that have a common 
mechanism of toxicity.'' Aventis CropScience believes that ``available 
information'' in this context includes not only toxicity, chemistry, 
and exposure data, but also scientific policies and methodologies for 
understanding common mechanisms of toxicity and conducting cumulative 
risk assessments.
    Further, Aventis does not have, at this time, available data to 
determine whether tralomethrin and deltamethrin have a common mechanism 
of toxicity with other substances. For the purposes of this tolerance 
action, therefore, no assumption has been made that tralomethrin and 
deltamethrin have a common mechanism of toxicity with other substances.

E. Safety Determination

    1. U.S. population. The toxicity and residue data base for 
deltamethrin and tralomethrin is considered to be valid, reliable and 
essentially complete according to existing regulatory requirements. No 
evidence of oncogenicity has been observed for either compound. In 
accordance with EPA's ``Toxicology Endpoint Selection Process'' 
Guidance Document for acute exposures, the toxicology endpoint from the 
deltamethrin rat acute neurotoxicity study, 5.0 mg/kg/day, was used. 
For chronic exposures to deltamethrin and tralomethrin, the Reference 
Dose (RfD) of 0.01 mg/kg body weight/day established for deltamethrin 
based on the NOAEL from the 2-year rat feeding study and a 100-fold 
safety factor to account for interspecies extrapolation and 
intraspecies variation was used.
    For the overall U.S. population, acute dietary exposure at the 
99.9th percentile results in utilization of 5.3% of the acute RfD that 
is equivalent to a Margin of Exposure (MOE) of 1,901. For the overall 
U.S. population, chronic dietary exposure results in a utilization of 
1.0% of the RfD. Using an upper bound estimate of potential non-dietary 
exposures for a worst case scenario (flea treatment) results in a MOE 
of at least 59,229 for adults. Utilizing the scenario of chronic 
dietary exposure plus an upper bound estimate of potential non-dietary 
exposure from a worst case scenario (flea treatment), it is shown that 
for aggregate exposure to deltamethrin and tralomethrin there is an MOE 
of 15,559 for adults. For acute and short-term exposures there is 
generally no concern for MOEs greater than 100. For chronic exposure, 
there is generally no concern for exposure below 100% of the RfD 
because the RfD represents the level at or below which daily aggregate 
dietary exposure over a lifetime will not pose appreciable risks to 
human health.
    In conclusion, there is reasonable certainty that no harm will 
result to the U.S. population, in general, from dietary or aggregate 
exposure to deltamethrin and/or tralomethrin.
    2. Infants and children. Data from developmental toxicity studies 
in rats and rabbits, and multi-generation reproduction studies in rats, 
are generally used to assess the potential for increased sensitivity of 
infants and children. The developmental toxicity studies are designed 
to evaluate adverse effects on the developing organism resulting from 
pesticide exposure during prenatal development. Reproduction studies 
provide information relating to reproductive and other effects on 
adults and offspring from prenatal and postnatal exposure to the 
pesticide. None of these studies conducted with deltamethrin or 
tralomethrin indicated developmental or reproductive effects as a 
result of exposure to these materials.
    FFDCA section 408 provides that EPA may apply an additional safety 
factor for infants and children in the case of threshold effects to 
account for prenatal and postnatal toxicity and the completeness of the 
data base. Based on the current toxicological data requirements, the 
data base relative to prenatal and postnatal effects in children is 
complete. Although no indication of increased susceptibility to younger 
animals was noted in any of the above studies, or in the majority of 
studies with other pyrethroids, several publications have reported that 
deltamethrin is more toxic to neonate and weanling animals than to 
adults. However, a joint industry group was unable to reproduce these 
findings. Furthermore, the RfD (0.01 mg/kg/day) that has been 
established for deltamethrin is already more than 1,000-fold lower than 
the lowest NOAEL from the developmental and reproduction studies. 
Therefore, the RfD of 0.01 mg/kg/day is appropriate for assessing 
chronic aggregate risk to infants and children and an additional 
uncertainty factor is not warranted. Also, the NOAEL of 5.0 mg/kg/day 
from the rat acute neurotoxicity study is appropriate to use in acute 
dietary, short-term non-dietary, and aggregate exposure assessments.
    For the population subgroup described as infants, less than 1 year 
old, the acute dietary exposure at the 99.9th percentile utilizes 7.2% 
of the acute RfD that is equivalent to a MOE of 1,382. For the 
population subgroup described as children 1-6 years old, the acute 
dietary exposure at the 99.9th percentile utilizes 6.7% of the acute 
RfD that is equivalent to a MOE of 1,504. For infants less than 1 year 
old, chronic dietary exposure results in a utilization of 0.9% of the 
RfD, and for children 1-6 years old 2.3% of the RfD is utilized. Using 
an upper bound estimate of potential non-dietary exposures for a worst 
case scenario (flea treatment) results in an MOE of at least 15,015 for 
infants less than 1 year old, and an MOE of at least 15,974 for 
children 1-6 years old. Utilizing the scenario of chronic dietary 
exposure plus an upper bound estimate of potential non-dietary exposure 
from a worst case scenario (flea treatment) it is shown that for 
aggregate exposure to deltamethrin and tralomethrin, there is an MOE of 
at least 4,900 for infants less than 1 year old, and an MOE of 4,250 
for children 1-6 years old. For acute and short-term exposures there is 
generally no concern for MOEs greater than 100. For chronic exposure, 
there is generally no concern for exposure below 100% of the RfD 
because the RfD represents the level at or below which daily aggregate 
dietary exposure over a lifetime will not pose appreciable risks to 
human health.
    In summary, there is reasonable certainty that no harm will result 
to infants and children from aggregate exposure to either deltamethrin 
or tralomethrin.

F. International Tolerances

    Deltamethrin is a broad spectrum insecticide used throughout the 
world to control pests of livestock, crops, ornamentals plants and 
turf, and household, commercial, and industrial food use areas. A 
reevaluation of the maximum residue limits (MRLs) was conducted in 
1994, in accordance with the EC Directive (91/414/EEC) Registration 
Requirements for Plant Protection Products. A comparison of the 
proposed/current CODEX MRLs and proposed/established tolerances for 
deltamethrin is presented below:

[[Page 56304]]



 
----------------------------------------------------------------------------------------------------------------
                                                        Proposed Tolerance
                     Commodity                            (USEPA) (PPM)       Proposed/Current MRL (CODEX) (PPM)
----------------------------------------------------------------------------------------------------------------
Almond hulls                                                             1.2                                  --
----------------------------------------------------------------------------------------------------------------
Apples, wet pomace                                                       1.2                                  --
----------------------------------------------------------------------------------------------------------------
 Artichokes                                                              0.5                                0.05
----------------------------------------------------------------------------------------------------------------
Brassica, head and stem crop subgroup 5A, excluding                     0.50           0.2 (brassica vegetables)
 cabbage
----------------------------------------------------------------------------------------------------------------
Bulb vegetables                                                          1.5        0.1 (bulb vegetables, except
                                                                                                   fennel, bulb)
----------------------------------------------------------------------------------------------------------------
Cabbage (w/wrapper leaves)                                               1.5                                  --
----------------------------------------------------------------------------------------------------------------
Cabbage (w/o wrapper leaves)                                            0.15           0.2 (brassica vegetables)
----------------------------------------------------------------------------------------------------------------
Carambola (star fruit)                                                   0.2                                  --
----------------------------------------------------------------------------------------------------------------
Corn, field grain                                                       0.06                 1.0 (cereal grains)
----------------------------------------------------------------------------------------------------------------
Corn, forage (field)                                                     0.7                                  --
----------------------------------------------------------------------------------------------------------------
Corn, fodder/stover (field)                                              7.0       0.5 (straw and fodder, cereal
                                                                                                         grains)
----------------------------------------------------------------------------------------------------------------
Corn, refined oil                                                        0.6                                  --
----------------------------------------------------------------------------------------------------------------
Corn, flour                                                             0.18                                  --
----------------------------------------------------------------------------------------------------------------
Corn, meal                                                              0.12                                  --
----------------------------------------------------------------------------------------------------------------
Corn, milled by products                                                0.18                                  --
----------------------------------------------------------------------------------------------------------------
Cucurbit vegetables                                                     0.06                                 0.2
----------------------------------------------------------------------------------------------------------------
Eggs                                                                    0.02                                  --
----------------------------------------------------------------------------------------------------------------
Fruiting vegetables                                                     0.25                                 0.2
----------------------------------------------------------------------------------------------------------------
Leafy vegetables                                                         4.5                                 0.5
----------------------------------------------------------------------------------------------------------------
Lichi fruit                                                              0.2                                  --
----------------------------------------------------------------------------------------------------------------
Milk, fat (reflecting 0.02 ppm in whole milk)                            0.1  0.02 (milks); and 0.03 cattle milk
----------------------------------------------------------------------------------------------------------------
Mustard greens                                                           4.5           0.2 (brassica vegetables)
----------------------------------------------------------------------------------------------------------------
Pome fruit                                                               0.2                                 0.1
----------------------------------------------------------------------------------------------------------------
Poultry, fat                                                            0.05                   0.5 (chicken fat)
----------------------------------------------------------------------------------------------------------------
Poultry, mbyp                                                           0.02                                  --
----------------------------------------------------------------------------------------------------------------
Poultry, meat                                                           0.02       0.01 (poultry meat); and 0.03
                                                                                                (chicken muscle)
----------------------------------------------------------------------------------------------------------------
Prunes                                                                   2.4                                  --
----------------------------------------------------------------------------------------------------------------
Rapeseed (including canola and crambe)                                  0.12                       0.1 (oilseed)
----------------------------------------------------------------------------------------------------------------
Root vegetable, except sugarbeet (subgroup 1B):                         0.15    0.01 (root and tuber vegetables)
 roots
----------------------------------------------------------------------------------------------------------------
Ruminant fat                                                            0.04                                 0.5
----------------------------------------------------------------------------------------------------------------
Ruminant mbyp                                                           0.02      0.05 (edible offal, mammalian)
----------------------------------------------------------------------------------------------------------------
Ruminant meat                                                           0.02                                 0.5
----------------------------------------------------------------------------------------------------------------
Sorghum, forage                                                          0.5                                  --
----------------------------------------------------------------------------------------------------------------
Sorghum, fodder/stover                                                   2.0       0.5 (straw and fodder, cereal
                                                                                                         grains)
----------------------------------------------------------------------------------------------------------------
Sorghum, grain                                                           0.5                 1.0 (cereal grains)
----------------------------------------------------------------------------------------------------------------

[[Page 56305]]

 
Soybeans                                                                0.05       0.5 (legume animal feeds, dry
                                                                                                         weight)
----------------------------------------------------------------------------------------------------------------
Stone fruit                                                              0.6                                0.05
----------------------------------------------------------------------------------------------------------------
Sunflower seeds                                                         0.05                       0.1 (oilseed)
----------------------------------------------------------------------------------------------------------------
Tops                                                                     4.0                                  --
----------------------------------------------------------------------------------------------------------------
Tree nuts                                                                0.1                                  --
----------------------------------------------------------------------------------------------------------------
Tuberous and corm vegetables subgroup 1C, excluding                     0.04    0.01 (root and tuber vegetables)
 artichokes
----------------------------------------------------------------------------------------------------------------
Wheat gluten (post harvest)                                              1.4                                  --
----------------------------------------------------------------------------------------------------------------
Wheat, grain (post harvest)                                              2.0                                 1.0
----------------------------------------------------------------------------------------------------------------
Wheat, grain dust (post harvest)                                         2.7                                  --
----------------------------------------------------------------------------------------------------------------


[FR Doc. 01-27598 Filed 11-06-01; 8:45 am]
BILLING CODE 6560-50-S