Notice of Filing a Pesticide Petition to Establish a Tolerance for a Certain Pesticide Chemical in or on Food

Note: EPA no longer updates this information, but it may be useful as a reference or resource.

[Federal Register: November 7, 2001 (Volume 66, Number 216)]
[Notices]
[Page 56298-56305]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07no01-71]

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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:
miller.joanne@epa.gov.

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: ``opp-docket@epa.gov,'' 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

Notice of Filing a Pesticide Petition to Establish a Tolerance for a Certain Pesticide Chemical in or on Food

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