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sethoxydim (Poast) Pesticide Petition Filing 1/00



[Federal Register: January 18, 2000 (Volume 65, Number 11)]
[Notices]
[Page 2612-2617]
>From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18ja00-61]

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ENVIRONMENTAL PROTECTION AGENCY

[PF-913; FRL-6486-4]


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

AGENCY:  Environmental Protection Agency (EPA).

ACTION:  Notice.

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

DATES:  Comments, identified by docket control number PF-913, must be
received on or before February 17, 2000.

ADDRESSES:  Comments may be submitted by mail, electronically, or in
person. Please follow the detailed instructions for each method as
provided in Unit I.C. of the ``SUPPLEMENTARY INFORMATION.'' To ensure
proper receipt by EPA, it is imperative that you identify docket
control number PF-913 in the subject line on the first page of your
response.

FOR FURTHER INFORMATION CONTACT:  By mail: Shaja R. Brothers,
Registration Division (7505C), Office of Pesticide Programs,
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460;
telephone number: (703) 308-3194; e-mail address:
brothers.shaja@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'' 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-913. The official record
consists of the documents specifically referenced in this action, any
public comments received during an applicable comment period, and other
information related to this action, including any information claimed
as confidential business information (CBI). This official record
includes the documents that are physically located in the docket, as
well as the documents that are referenced in those documents. The
public version of the official record does not include any information
claimed as CBI. The public version of the official record, which
includes printed, paper versions of any electronic comments submitted
during an applicable comment period, is available for inspection in the
Public Information and Records Integrity Branch (PIRIB), Rm. 119,
Crystal Mall 2 (CM 2), 1921 Jefferson Davis Highway, Arlington, VA,
from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal
holidays. The PIRIB telephone number is (703) 305-5805.

C. How and to Whom Do I Submit Comments?

    You may submit comments through the mail, in person, or
electronically. To ensure proper receipt by EPA, it is imperative that
you identify docket control number PF-913 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, 401 M St., SW., Washington, DC 20460.
    2. In person or by courier. Deliver your comments to: Public
Information and Records Integrity Branch (PIRIB), Information Resources
and Services Division (7502C), Office of Pesticide Programs (OPP),
Environmental Protection Agency, Rm. 119, CM 2, 1921 Jefferson Davis
Highway, Arlington, VA. The PIRIB is open from 8:30 a.m. to 4 p.m.,
Monday through Friday, excluding legal holidays. The PIRIB telephone
number is (703) 305-5805.

    3. Electronically. You may submit your comments electronically by
e-mail to: ``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-913. 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

[[Page 2613]]

disclosed except in accordance with procedures set forth in 40 CFR part
2. In addition to one complete version of the comment that includes any
information claimed as CBI, a copy of the comment that does not contain
the information claimed as CBI must be submitted for inclusion in the
public version of the official record. Information not marked
confidential will be included in the public version of the official
record without prior notice. If you have any questions about CBI or the
procedures for claiming CBI, please consult the person identified under
``FOR FURTHER INFORMATION CONTACT.''

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

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

II. What Action is the Agency Taking?

     EPA has received 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 petitions. 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: January 6, 2000.
James Jones,
Director, Registration Division, Office of Pesticide Programs.

Summaries of Petitions

    The 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 petitioner and represents the view
of the petitioners. EPA is publishing the petition summaries verbatim
without editing them in any way. The petition summaries announce 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. Interregional Project Number 4

 9E6012 and 9E6021

    EPA has received pesticide petitions (9E6012 and 9E6021) from the
Interregional Project Number 4 (IR-4), New Jersey Agricultural
Experiment Station, Rutgers University, New Brunswick, New Jersey 08903
proposing, pursuant to section 408(d) of the Federal Food, Drug, and
Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180 by
establishing a tolerance for residues of sethoxydim in or on the raw
agricultural commodities (RAC) pistachio and safflower at 0.2 and 15
parts per million (ppm). EPA has determined that the petitions contain
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 petitions. Additional data may be needed before
EPA rules on the petitions. This notice includes a summary of petitions
prepared by BASF Corporation Agricultural Products, P.O. Box 13528,
Research Triangle Park, NC 27709.

A. Residue Chemistry

    1. Plant metabolism. The qualitative nature of the residues in
plants is adequately understood for the purposes of registration.
    2. Analytical method. Analytical methods for detecting levels of
sethoxydim and its metabolites in or on food with a limit of detection
that allows monitoring of food with residues at or above the levels set
in these tolerances were submitted to EPA. The proposed analytical
method involves extraction, partition, and clean-up. Samples are then
analyzed by gas chromatography with sulfur-specific flame photometric
detection. The limit of quantitation is 0.05 ppm.

B. Toxicological Profile

    1. Acute toxicity. Based on the available acute toxicity data,
sethoxydim does not pose any acute dietary risks. A summary of the
acute toxicity studies are as follows:
    i. Acute oral toxicity-- Rat. Toxicity Category III; lethal dose
(LD50) = 3,125 milligrams/kilograms (mg/kg) male, 2,676 mg/
kg female respectively.
    ii. Acute dermal toxicity-- Rat. Toxicity Category III;
LD50 > 5,000 mg/kg (male and female).
    iii. Acute inhalation toxicity-- Rat. Toxicity Category III; lethal
concentration (LC50) (4-hour) = 6.03 milligram/liter (mg/L)
(male), 6.28 mg/L (female) respectively.
    iv. Primary eye irritation-- Rabbit. Toxicity Category IV; no
irritation.
    v. Primary dermal irritation-- Rabbit. Toxicity Category IV; no
irritation.
    vi. Dermal sensitization-- Guinea pig. Waived because no
sensitization was seen in guinea pigs dosed with the end-use product
poast 18% active ingredient (a.i.).
    2. Genotoxicity. Ames assays were negative for gene mutation in
Salmonella typhimurium strains TA98, TA100, TA1535, and TA 1537, with
and without metabolic activity. A Chinese hamster bone marrow
cytogenetic assay was negative for structural chromosomal aberrations
at doses up to 5,000 mg/kg in Chinese hamster bone marrow cells in
vivo. Recombinant assays and forward mutations tests in Bacillus
subtilis, Escherichia coli, and S. typhimurium were all negative for
genotoxic effects at concentrations of greater than or equal to 100%.
    3. Reproductive and developmental toxicity. A developmental
toxicity study in rats fed dosages of 0, 50, 180, 650, or 1,000 mg/kg/
day with a maternal no observed adverse effect level (NOAEL) of 180 mg/
kg/day and a maternal lowest observed adverse effect level (LOAEL) of
650 mg/kg/day (irregular gait, decreased activity, excessive
salivation, and anogenital staining); and a developmental NOAEL of 180
mg/kg/day, and a developmental LOAEL of 650 mg/kg/day (21 to 22%
decrease in fetal weights, filamentous tail, and lack of tail due to
the absence of sacral and/or caudal vertebrae, and delayed ossification
in the hyoids, vertebral centrum and/or transverse processes,
sternebrae and/or metatarsals, and pubes).

[[Page 2614]]

    A developmental toxicity study in rabbits fed doses of 0, 80, 160,
320, or 400 mg/kg/day with a maternal NOAEL of 320 mg/kg/day and a
maternal LOAEL of 400 mg/kg/day (37% reduction in body weight gain
without significant differences in group mean body weights and
decreased food consumption during dosing) and a developmental NOAEL
greater than 400 mg/kg/day highest dose tested (HDT).
    A 2-generation reproduction study with rats fed diets containing 0,
150, 600, or 3,000 ppm (approximately 0, 7.5, 30, and 150 mg/kg/day)
with no reproductive effects observed under the conditions of the
study.
    4. Subchronic toxicity. A 21-day dermal study in rabbits with a
NOAEL of > 1,000 mg/kg/day limit dose. The only dose-related finding
was slight epidermal hyperplasia at the dosing site in nearly all males
and females dosed at 1,000 mg/kg/day. This was probably an adaptive
response.
    5. Chronic toxicity. A summary of the chronic toxicity studies are
as follows:
    i. A 1-year feeding study with dogs fed diets containing 0, 8.86/
9.41, 17.5/19.9, and 110/129 mg/kg/day (males/females) with a NOAEL of
8.86/9.41 mg/kg/day (males/females) based on equivocal anemia in male
dogs at the 17.5-mg/kg/day dose level.
    ii. A 2-year chronic feeding/carcinogenicity study with mice fed
diets containing 0, 40, 120, 360, or 1,080 ppm (equivalent to 0, 6, 18,
54, and 162 mg/kg/day) with a systemic NOAEL of 120 ppm (18 mg/kg/day)
based on non-neoplastic liver lesions in male mice at the 360-ppm (54
mg/kg/day) dose level. There were no carcinogenic effects observed
under the conditions of the study. The maximum tolerated dose (MTD) was
not achieved in female mice.
    iii. A 2-year chronic feeding/carcinogenic study with rats fed
diets containing 0, 2, 6, or 18 mg/kg/day with a systemic NOAEL greater
than or equal to 18 mg/kg/day HDT. There were no carcinogenic effects
observed under the conditions of the study. This study was reviewed
under current guidelines and was found to be unacceptable because the
doses used were insufficient to induce a toxic response and an MTD was
not achieved.
    A second chronic feeding/carcinogenic study with rats fed diets
containing 0, 360, or 1,080 ppm (equivalent to 18.2/23.0, and 55.9/71.8
mg/kg/day (males/females)). The dose levels were too low to elicit a
toxic response in the test animals and failed to achieve an MTD or
define a LOAEL. Slight decreases in body weights in rats at the 1,080-
ppm dose level, although not biologically significant, support a free-
standing NOAEL of 1,080 ppm (55.9/71.8 mg/kg/day (males/females)).
There were no carcinogenic effects observed under the conditions of the
study.
    6. Animal metabolism. In a rat metabolism study, excretion was
extremely rapid and tissue accumulation was negligible.
    7. Metabolite toxicology. As a condition to registration, BASF had
been asked to submit additional toxicology studies for the hydroxy-
metabolites of sethoxydim. EPA agreed with BASF's recommendation to use
the most abundant metabolite, 5-OH-MSO2, as surrogate for all
metabolites. Based on these data, it was concluded that the
toxicological potency of the plant hydroxy-metabolites is likely to be
equal or less than that of the parent compound. The tolerance
expression for sethoxydim and its metabolites containing the 2-
cyclohexen-1-one moiety, measured as parent. Hence, the hyrdroxy-
metabolites are figured into all tolerance calculations.
    8. Endocrine disruption. No specific tests have been performed with
sethoxydim to determine whether the chemical may have an effect in
humans that is similar to an effect produced by naturally-occurring
estrogen or other endocrine effects.

C. Aggregate Exposure

    1. Dietary exposure--i. Food. For purposes of assessing the
potential dietary exposure, BASF has estimated aggregate exposure based
on the theoretical maximum residue contribution (TMRC) from existing
and pending tolerances for sethoxydim. (The TMRC is a ``worst case''
estimate of dietary exposure since it is assumed that 100% of all crops
for which tolerances are established are treated and that pesticide
residues are at the tolerance levels). The TMRC from existing
tolerances for the overall U.S. population is estimated at
approximately 44% of the chronic population adjusted dose (cPAD). BASF
estimates indicate that dietary exposure will not exceed the cPAD for
any population subgroup for which EPA has data. This exposure
assessment relies on very conservative assumptions 100% of crops will
contain sethoxydim residues and those residues would be at the level of
the tolerance which results in an overestimate of human exposure.
    ii. Drinking water. Other potential sources of exposure of the
general population to residues of pesticides are residues in drinking
water and exposure from non-occupational sources. Based on the
available studies submitted to EPA for assessment of environmental
risk, BASF does not anticipate exposure to residues of sethoxydim in
drinking water. There is no established maximum concentration level for
residues of sethoxydim in drinking water under the Safe Drinking Water
Act.
    2. Non-dietary exposure. BASF has not estimated non-occupational
exposure for sethoxydim. Sethoxydim is labeled for use by homeowners on
and around the following use sites: flowers, evergreens, shrubs, trees,
fruits, vegetables, ornamental groundcovers, and bedding plants. Hence,
the potential for non-occupational exposure to the general population
exists. However, these use sites do not appreciably increase exposure.
Protective clothing requirements, including the use of gloves,
adequately protect homeowners when applying the product. The product
may only be applied through hose-end sprayers or tank sprayers as a
0.14% solution. Sethoxydim is not a volatile compound so inhalation
exposure during and after application would be negligible. Dermal
exposure would be minimal in light of the protective clothing and the
low application rate. According to BASF, post-treatment (re-entry)
exposure would be negligible for these use sites as contact with
treated surfaces would be low. BASF concludes that the potential for
non-occupational exposure to the general population is insignificant.

D. Cumulative Effects

    BASF also considered the potential for cumulative effects of
sethoxydim and other substances that have a common mechanism of
toxicity. BASF is aware of one other a.i. which is structurally
similar, clethodim. However BASF believes that consideration of a
common mechanism of toxicity is not appropriate at this time. BASF does
not have any reliable information to indicate that toxic effects
produced by sethoxydim would be cumulative with clethodim or any other
chemical; thus, BASF is considering only the potential risks of
sethoxydim in its exposure assessment.

E. Safety Determination

    1. U.S. population. Using the conservative exposure assumptions
described above, BASF has estimated that aggregate exposure to
sethoxydim will utilize 44% of the cPAD for the U.S. population. EPA
generally has no concern for exposures below 100% of the cPAD.
Therefore, based on the completeness and reliability of the toxicity
data, and the conservative exposure assessment, BASF concludes that
there is a reasonable certainty that

[[Page 2615]]

no harm will result from aggregate exposure to residues of sethoxydim,
including all anticipated dietary exposure and all other non-
occupational exposures.
    2. Infants and children--i. Developmental toxicity. Developmental
toxicity was observed in a developmental toxicity study using rats but
was not seen in a developmental toxicity study using rabbits. In the
developmental toxicity study in rats a maternal NOAEL of 180 mg/kg/day
and a maternal LOAEL of 650 mg/kg/day (irregular gait, decreased
activity, excessive salivation, and anogenital staining) was
determined. A developmental NOAEL of 180 mg/kg/day and a developmental
LOAEL of 650 mg/kg/day (21 to 22% decrease in fetal weights,
filamentous tail and lack of tail due to the absence of sacral and/or
caudal vertebrae, and delayed ossification in the hyoids, vertebral
centrum and/or transverse processes, sternebrae and/or metatarsals, and
pubes). Since developmental effects were observed only at doses where
maternal toxicity was noted, the developmental effects observed are
believed to be secondary effects resulting from maternal stress.
    ii. Reproductive toxicity. A 2-generation reproduction study with
rats fed diets containing 0, 150, 600, or 3,000 ppm (approximately 0,
7.5, 30, and 150 mg/kg/day) produced no reproductive effects during the
course of the study. Although the dose levels were insufficient to
elicit a toxic response, the registrant has considered this study
usable for regulatory purposes and has established a free-standing
NOAEL of 3,000 ppm (approximately 150 mg/kg/day).
    iii. Chronic population adjusted dose. Based on the demonstrated
lack of significant developmental or reproductive toxicity, BASF
believes that the cPAD used to assess safety to children should be the
same as that for the general population, 0.09 mg/kg/day. Using the
conservative exposure assumptions described above, BASF has concluded
that the most sensitive child population is that of children ages 1 to
6 years old. BASF calculates the exposure to this group to be
approximately 95% of the cPAD for all uses (including those proposed in
this document). Based on the completeness and reliability of the
toxicity data and the conservative exposure assessment, BASF concludes
that there is a reasonable certainty that no harm will result to
infants and children from aggregate exposure to the residues of
sethoxydim, including all anticipated dietary exposure and all other
non-occupational exposures.

F. International Tolerances

    A maximum residue level has not been established for sethoxydim on
pistachio and safflower by the Codex Alimentarius Commission.

 [FR Doc. 00-1064 Filed 1-14-00; 8:45 am]
BILLING CODE 6560-50-F