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Deltamethrin - Pesticide Petition Filing 8/98

[Federal Register: August 26, 1998 (Volume 63, Number 165)]
[Notices]
[Page 45487-45497]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26au98-58]

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ENVIRONMENTAL PROTECTION AGENCY
[PF-826; FRL-6023-5]
Notice of Filing of Pesticide Petitions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.

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SUMMARY: This notice announces the initial filing of pesticide
petitions proposing the establishment of regulations for residues of
certain pesticide chemicals in or on various food commodities.
DATES: Comments, identified by the docket control number PF-826, must
be received on or before September 25, 1998.
ADDRESSES: By mail submit written comments to: Public Information and
Records Integrity Branch, Information Resources and Services Division
(7502C), Office of Pesticides Programs, Environmental Protection
Agency, 401 M St., SW., Washington, DC 20460. In person bring comments
to: Rm. 119, CM #2, 1921 Jefferson Davis Highway, Arlington, VA.
    Comments and data may also be submitted electronically to: opp-
docket@epamail.epa.gov. Follow the instructions under "SUPPLEMENTARY
INFORMATION." No confidential business information should be submitted
through e-mail.
    Information submitted as a comment concerning this document may be

[[Page 45488]]

claimed confidential by marking any part or all of that information as
"Confidential Business Information" (CBI). CBI should not be
submitted through e-mail. Information marked as CBI will not be
disclosed except in accordance with procedures set forth in 40 CFR part
2. A copy of the comment that does not contain CBI must be submitted
for inclusion in the public record. Information not marked confidential
may be disclosed publicly by EPA without prior notice. All written
comments will be available for public inspection in Rm. 1132 at the
address given above, from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays.

FOR FURTHER INFORMATION CONTACT: The product manager listed in the
table below:

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                                   Office location/
        Product Manager            telephone number          Address
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Beth Edwards (PM 3)...........  Rm. 206, CM #2, 703-    1921 Jefferson
                                 305-5400, e-            Davis Hwy,
                                 mail:edwards.beth@epa   Arlington, VA
                                 mail.epa.gov.
Sidney Jackson (PM 22)........  Rm. 233, CM #2, 703-    Do.
                                 305-7610, e-mail:
                                 jackson.sidney@epamai
                                 l.epa.gov.
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SUPPLEMENTARY INFORMATION: EPA has received pesticide petitions as
follows proposing the establishment and/or amendment of regulations for
residues of certain pesticide chemicals in or on various food
commodities under section 408 of the Federal Food, Drug, and Comestic
Act (FFDCA), 21 U.S.C. 346a. EPA has determined that these petitions
contain data or information regarding the elements set forth in section
408(d)(2); however, EPA has not fully evaluated the sufficiency of the
submitted data at this time or whether the data supports granting of
the petition. Additional data may be needed before EPA rules on the
petition.
    The official record for this notice of filing, as well as the
public version, has been established for this notice of filing under
docket control number [PF-826] (including comments and data submitted
electronically as described below). A public version of this record,
including printed, paper versions of electronic comments, which does
not include any information claimed as CBI, is available for inspection
from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal
holidays. The official record is located at the address in
"ADDRESSES" at the beginning of this document.
    Electronic comments can be sent directly to EPA at:
    opp-docket@epamail.epa.gov

    Electronic comments must be submitted as an ASCII file avoiding the
use of special characters and any form of encryption. Comments and data
will also be accepted on disks in Wordperfect 5.1 file format or ASCII
file format. All comments and data in electronic form must be
identified by the docket number (insert docket number) and appropriate
petition number. Electronic comments on notice may be filed online at
many Federal Depository Libraries.

List of Subjects

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

Dated: August 13, 1998.

    James Jones,

Director, Registration Division, Office of Pesticide Programs.

Summaries of Petitions

    Petitioner summaries of the pesticide petitions are printed below
as required by section 408(d)(3) of the FFDCA. The summaries of the
petitions were prepared by the petitioners and represent the views of
the petitioners. EPA is publishing the petition summaries verbatim
without editing them in any way. The petition summary announces the
availability of a description of the analytical methods available to
EPA for the detection and measurement of the pesticide chemical
residues or an explanation of why no such method is needed.

1. AgrEvo USA Company (acting as registered US agent for Hoechst
Schering AgrEvo, S.A.)

PP 7F4909

    EPA has received a pesticide petition (PP 7F4909) from AgrEvo USA
Company (acting as registered U.S. agent for Hoechst Schering AgrEvo,
S.A.), 2711 Centerville Road, Wilmington, DE 19808 proposing pursuant
to section 408(d) of the Federal Food, Drug, and Cosmetic Act, 21
U.S.C. 346a(d), to amend 40 CFR part 180 by establishing a tolerance
for residues of deltamethrin in or on various food and feed
commodities. Tolerances are currently established at 40 CFR 180.435 in
or on the following commodities for residues of deltamethrin [(1R, 3R)-
3(2,2-dibromovinyl)-2,2-dimethylcyclopropanecarboxylic acid (S)-alpha-
cyano-3-phenoxybenzyl ester] and relevant metabolites: cottonseed at
0.04 parts per million (ppm), cottonseed oil at 0.2 ppm, tomatoes at
0.2 ppm, and tomato products (concentrated) at 1.0 ppm.
    EPA has determined that the petition contains data or information
regarding the elements set forth in section 408(d)(2) of the FFDCA;
however, EPA has not fully evaluated the sufficiency of the submitted
data at this time or whether the data supports granting of the
petition. Additional data may be needed before EPA rules on the
petition.
    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.

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, based on

[[Page 45489]]

gas chromatography (GLC) equipped with an electron capture detector
(ECD) and a DB-1 (or equivalent) capillary column, 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 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 for
deltamethrin in the rat are 66.7 milligram/kilograms (mg/kg) for males,
86 mg/kg for females, and for tralomethrin 99 mg/kg for males, 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 are 2.2
mg/L for deltamethrin and greater than 0.286 mg/L for tralomethrin.
    2. Genotoxicty. 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
developmental toxicity study conducted with deltamethrin indicated a
maternal no observed effect level (NOEL) of 3.3 mg/kg/day based on
clinical observations, decreased weight gain and mortality. The
developmental NOEL was 11 mg/kg/day higest dose tested (HDT).
    In a rabbit developmental toxicity study with deltamethrin, the
maternal NOEL 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 NOEL was considered to be 25 mg/kg/day based on retarded
ossification of the pubic 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 NOEL
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 NOEL 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 NOEL was 12.5 mg/kg/day based on mortality
while the developmental NOEL was judged to be greater than or equal to
25 mg/kg/day HDT. In the second study, the maternal NOEL was 8 mg/kg/
day based on body weight effects while the developmental NOEL was 32
mg/kg/day HDT.
    In a 2-generation reproduction study with tralomethrin in rats, the
parental NOEL was 0.75 mg/kg/day based on body weight deficits while
the NOEL 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 NOEL was judged to be 1.0 mg/kg/day based on reduced
body weight gain and slight hypersensitivity. In a more recent 90-day
rat dietary study with deltamethrin, the NOEL 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
NOEL's 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 NOEL
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 NOEL for this study was 1 mg/kg/day
based on tremors, unsteadiness, jerking movements, salivation,
vomiting, liquid feces and/or dilatation of the pupils. In the second
study, deltamethrin was administered by capsule without a vehicle to
beagle dogs. The NOEL 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 NOEL 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
μg/l was the NOEL for systemic effects in this study.
    ii. Tralomethrin. Tralomethrin was administrated 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 NOEL was considered to be
1 mg/kg/day.
    Tralomethrin was administered by capsule to beagle dogs for 13
weeks. The NOEL 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 NOEL
for this study was 1,000 mg/kg/day.
    5. Chronic toxicity and oncogenicity-- i. Deltamethrin.
Deltamethrin was administered in the diet to beagle dogs for 2 years.
No treatment-related effects were observed and the NOEL 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 NOEL 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 NOEL 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 NOEL 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 balloon cells. No evidence of
carcinogenicity was noted in either study.

[[Page 45490]]

    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 NOEL 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 NOEL 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 14 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 NOEL for this study
was considered to be 1 mg/kg/day.
    Tralomethrin was administered by gavage to rats for 24 months. The
NOEL 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 NOEL 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. 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, effects
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 no observed
adversed effect level (NOAEL) for neurotoxicity in this study was 5 mg/
kg.
    In a subchronic neurotoxicity study with deltamethrin in rats,
effects 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).
    7. 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 pattern of the
debrominated tralomethrin is exactly the same as that of the metabolic
pattern of deltamethrin.
    8. Endocrine effects. 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.

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 would include exposures resulting from non-
food use 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--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 use, and
associated tolerances, is pending 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 pending
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 dietary exposure evaluation mode (DEEM).
This chronic risk assessment was conduced using anticipated residues
based on field trial or monitoring data, percent crop treated, and
percent food handling establishments treated.
    2. Drinking water . Tralomethrin and deltamethrin are immobile in
soil and, therefore, will not leach into groundwater. Additionally, due
to the insolubility and lipophilic nature of deltamethrin and
tralomethrin, any residues in surface water will rapidly and tightly
bind to soil particles and remain with sediment, therefore not
contributing to potential dietary exposure from drinking water.
    A screening evaluation of leaching potential of a typical
pyrethroid was conducted using EPA's pesticide root zone model (PRZM3).
Based on this screening assessment, the potential concentrations of a
pyrethroid in ground water at depths of 1 and 2 meters are essentially
zero <0.001 parts per billion (PPB). Surface water concentrations for
pyrethroids were estimated using PRZM3 and Exposure Analysis Modeling
System (EXAMS) using Standard EPA cotton runoff and Mississippi pond
scenarios. The maximum concentration predicted in the simulated pond
was 0.052 ppb. Concentrations in actual drinking water would be much
lower than the levels predicted in the hypothetical, small, stagnant
farm pond model since

[[Page 45491]]

drinking water derived from surface water would normally be treated
before consumption. Based on these analyses, the contribution of water
to the dietary risk estimate is negligible.
    3. 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, 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"senario 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 is
commonly used and they 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, a non-dietary and aggregate (non-dietary + chronic dietary)
exposure/risk assessment has been conducted for the combination of both
active ingredients. The total exposure to both materials was expressed
as "deltamethrin equivalents" and these were compared to the
toxicology endpoints identified for deltamethrin.

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". AgrEvo USA Company, acting as registered U.S.
agent for Hoechst Schering AgrEvo SA, 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, AgrEvo does not have, at this time, available data to
determine whether tralomethrin and/or 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/or 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 are 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, is used. For
chronic exposures to deltamethrin and tralomethrin, the Reference Dose
(RfD) of 0.01 mg/kg bodyweight/day established for deltamethrin based
on the NOEL from the 2-year rat feeding study and a 100-fold safety
factor to account for interspecies extrapolation and intraspecies
variation is used.
    For the overall U.S. population, acute dietary exposure at the
99.9th percentile results in a margin of exposure (MOE) of 1,406; the
MOE for the 99th percentile is 3,500; and at the 95th percentile the
MOE is 8,613. For the overall U.S. population, chronic dietary exposure
results in a utilization of 1.4% of the reference dose. Using an upper
bound estimate of potential non-dietary exposures for a worst case
scenario (flea treatment) results in an MOE of 160,000 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 31,100 for adults.
There is generally no concern for MOE's 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 multigeneration 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 pre-natal and post-natal 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 pre-and post-natal toxicity and the completeness of the
database. Based on the current toxicological data requirements, the
database relative to pre- and post-natal 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 recent publications have
reported that deltamethrin is more toxic to neonate and weanling
animals than to adults. However, a joint industry group currently
investigating this issue 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 NOEL
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 NOEL 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 non-nursing infants, less
than 1 year old, the MOE for acute dietary exposure at the 99.9th
percentile is 666; at the 99th percentile the MOE is 1,491; and at the
95th percentile the MOE is 8,755. For the population subgroup described
as children 1-6 years old, the MOE for acute dietary exposure is 871
for the 99.9th percentile; at the 99th percentile the MOE is 1,527; and
at the 95th percentile the MOE is 3,167. For non-nursing infants,
chronic dietary exposure results in a utilization of 1.9% of the RfD, and

[[Page 45492]]

for children 1-6 years old 3.7% of the reference dose is utilized.
Using an upper bound estimate of potential non-dietary exposures for a
worst case scenario (flea treatment) results in an MOE of 6,100 for
infants less than 1 year old, and an MOE of 6,600 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 6,775 for infants
less than 1 year old, and an MOE of 5,700 for children 1-6 years old.
There is generally no concern for MOE's 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 (MRL's) 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 MRL's and proposed/established tolerances for
deltamethrin is presented below:

------------------------------------------------------------------------------------------------------
                Commodity                  Proposed Tolerance (USEPA)   Proposed/Current MRL (CODEX)
                                                     (PPM)                        (PPM)
------------------------------------------------------------------------------------------------------
Barley, grain...........................              0.50                        1.0
Broccoli................................              0.50                        0.2
Cattle, fat.............................              0.15                        ---
Cattle, mbyp............................              0.05                        ---
Cattle, meat............................              0.05                        ---
Cereal grain dust.......................             65.0                         ---
Corn, field, grain......................              1.0                         1.0
Corn, pop, grain........................              0.5                         1.0
Corn, sweet, grain......................              0.5                         1.0
Corn, forage (field)....................              0.7                         ---
Corn, fodder (field)....................              7.0                         0.5
Cucurbits vegetables....................              0.05                        0.2
Eggs....................................              0.02                        ---
Goats, fat..............................              0.15                        ---
Goats, mbyp.............................              0.05                        ---
Goats, meat.............................              0.05                        ---
Hogs, fat...............................              0.15                        ---
Hogs, mbyp..............................              0.05                        ---
Hogs, meat..............................              0.05                        ---
Horses, fat.............................              0.15                        ---
Horses, mbyp............................              0.05                        ---
Horses, meat............................              0.05                        ---
Lettuce, head...........................              1.0                         0.2
Lettuce, leaf...........................              3.0                         0.5
Milk, Fat (reflecting 0.07 ppm in whole
 milk)..................................              0.6                         0.01 (milk)
Oats, grain.............................              0.5                         1.0
Poultry, fat............................              0.3                         ---
Poultry, mbyp...........................              0.02                        ---
Poultry, meat...........................              0.02                        ---
Rice, grain.............................              0.5                         1.0
Rye, grain..............................              0.5                         1.0
Sheep, fat..............................              0.15                        ---
Sheep, mbyp.............................              0.05                        ---
Sheep, meat.............................              0.05                        ---
Sorghum, grain..........................              1.0                         1.0
Sorghum, forage.........................              0.5                         ---
Sorghum, fodder.........................              2.0                         0.5
Soybeans................................              0.05                        0.1
Sunflower seed..........................              0.05                        0.1
Tomatoes................................              0.3                         0.2
Triticale, grain........................              0.5                         1.0
Wheat, forage...........................              8.0                         ---
Wheat, grain............................              1.0                         1.0
Wheat, hay..............................              8.0                         0.5
Wheat, straw............................              8.0                         0.5
Corn, refined oil.......................             10.0                         ---
Corn, flour.............................              3.0                         ---
Corn, meal..............................              2.0                         ---
Tomato products (concentrated)..........              1.5                         ---
Wheat bran..............................              4.0                         5.0
Wheat germ..............................              8.0                         ---
Soybean hulls...........................              0.25                        0.5
Cereal bran.............................              2.0                         ---
Rice hulls..............................              6.0                         ---

[[Page 45493]]

Corn, milled byproducts.................              3.0                         ---
--------------------------------------------------------------------------------------------------

    As far as can be determined, no CODEX MRL's are established or
proposed for tralomethrin.

G. Proposed Tolerances

    This pesticide petition proposes to amend 40 CFR 180.435 for the
insecticide deltamethrin as it relates to the following raw
agricultural, food, or feed commodities:

------------------------------------------------------------------------
              Commodity                          Parts per million
------------------------------------------------------------------------
Barley, grain.......................                    0.5
 Broccoli...........................                    0.5
 Cattle, fat........................                    0.15
 Cattle, mbyp.......................                    0.05
 Cattle, meat.......................                    0.05
 Cereal bran........................                    2.0
 Cereal grain dust..................                   65.0
 Corn, field, grain.................                    1.0
 Corn, pop, grain...................                    0.5
 Corn, sweet, grain.................                    0.5
 Corn, forage (field)...............                    0.7
 Corn, fodder (field)...............                    7.0
 Corn, refined oil..................                   10.0
 Corn, flour........................                    3.0
 Corn, meal.........................                    2.0
 Corn, milled byproducts............                    3.0
 Cottonseed.........................                    0.04
 Cottonseed oil.....................                    0.2
 Cucurbits vegetables...............                    0.05
 Eggs...............................                    0.02
 Goats, fat.........................                    0.15
 Goats, mbyp........................                    0.05
 Goats, meat........................                    0.05
 Hogs, fat..........................                    0.15
 Hogs, mbyp.........................                    0.05
 Hogs, meat.........................                    0.05
 Horses, fat........................                    0.15
 Horses, mbyp.......................                    0.05
 Horses, meat.......................                    0.05
 Lettuce, head......................                    1.0
 Lettuce, leaf......................                    3.0
 Milk, Fat (reflecting 0.07 ppm in
 whole milk)........................                    0.6
Oats, grain.........................                    0.5
 Poultry, fat.......................                    0.3
Poultry, mbyp.......................                    0.02
 Poultry, meat......................                    0.02
 Rice, grain........................                    0.5
 Rice, hulls........................                    6.0
 Rye, grain.........................                    0.5
 Sheep, fat.........................                    0.15
 Sheep, mbyp........................                    0.05
 Sheep, meat........................                    0.05
 Sorghum, grain.....................                    1.0
 Sorghum, forage....................                    0.5
 Sorghum, fodder....................                    2.0
 Soybeans...........................                    0.05
 Soybean hulls......................                    0.25
 Sunflower seed.....................                    0.05
 Tomatoes...........................                    0.3
Tomato products (concentrated)......                    1.5
 Triticale, grain...................                    0.5
 Wheat, bran........................                    4.0
 Wheat, forage......................                    8.0
 Wheat, germ........................                    8.0
 Wheat, grain.......................                    1.0
 Wheat, hay.........................                    8.0
 Wheat, straw.......................                    8.0
------------------------------------------------------------------------

[[Page 45494]]

H. Conclusions

    The proposed establishment of food and food/feed additive
tolerances for deltamethrin resulting from application to growing
crops, stored grain, and direct application to livestock would not pose
a significant risk to human health, including that of children, and is
in compliance with the requirements of the Food Quality Protection Act
of 1996. Thus, the tolerances proposed for residues of deltamethrin can
be established.

 [FR Doc. 98-22430 Filed 8-25-98; 8:45 am] BILLING CODE 6560-50-F