[Federal Register Volume 67, Number 176 (Wednesday, September 11, 2002)]
[Notices]
[Pages 57593-57597]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-23088]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2002-0236; FRL-7198-1]


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.

DATES: Comments, identified by docket ID number OPP-2002-0236 must be 
received on or before October 11, 2002.

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 ID 
number OPP-2002-0236 in the subject line on the first page of your 
response.

FOR FURTHER INFORMATION CONTACT: By mail: Jim Tompkins, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; 
telephone number: (703) 305-5704; and e-mail address: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does This Action Apply to Me?

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

[[Page 57594]]



 
------------------------------------------------------------------------
                                                          Examples of
           Categories                 NAICS codes         potentially
                                                       affected entities
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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 ID number OPP-2002-0236. 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 ID number OPP-2002-0236 in the subject line on the 
first page of your response.
    1. By mail. Submit your comments to: Public Information and Records 
Integrity Branch (PIRIB), Information Resources and Services Division 
(7502C), Office of Pesticide Programs (OPP), Environmental Protection 
Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
    2. In person or by courier. Deliver your comments to: Public 
Information and Records Integrity Branch (PIRIB), Information Resources 
and Services Division (7502C), Office of Pesticide Programs (OPP), 
Environmental Protection Agency, Rm. 119, Crystal Mall 2, 1921 
Jefferson Davis Highway, Arlington, VA. The PIRIB is open from 8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
PIRIB telephone number is (703) 305-5805.
    3. Electronically. You may submit your comments electronically by 
e-mail to: [email protected], or you can submit a computer disk as 
described above. Do not submit any information electronically that you 
consider to be CBI. Avoid the use of special characters and any form of 
encryption. Electronic submissions will be accepted in Wordperfect 6.1/
8.0 or ASCII file format. All comments in electronic form must be 
identified by docket ID number OPP-2002-0236. 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 
ID number assigned to this action in the subject line on the first page 
of your response. You may also provide the name, date, and Federal 
Register citation.

II. What Action Is the Agency Taking?

    EPA has received a pesticide petition as follows proposing the 
establishment and/or amendment of regulations for residues of a certain 
pesticide chemical in or on various food commodities under section 408 
of the Federal Food, Drug, and 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: August 30, 2002.
Debra Edwards,
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

[[Page 57595]]

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

BASF Corporation

PP 2F4075

    EPA has received a pesticide petition (2F4075) from BASF 
Corporation, P.O. Box 13528, Research Triangle Park, NC 27709-3528 
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, 2-[1-
(ethoxyimino)butyl]-5-[2-(ethylthio)propyl]-3-hydroxy-2-cyclohexen-1-
one and its metabolites containing the 2-cyclohexen-1-one moiety 
(calculated as the herbicide) in or on the raw agricultural commodity 
(RAC) corn, sweet (K+CHR at 0.4 part per million (ppm); corn, sweet, 
forage at 3.0 ppm; corn, sweet, stover at 3.5 ppm; milk at 0.5 ppm; 
cattle, meat byproduct, at 1.0 ppm; goat, meat byproduct at 1.0 ppm; 
hog, meat byproduct at 1.0 ppm; horse, meat byproduct at 1.0 ppm; and 
sheep, meat by product 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 
support granting of the petition. Additional data may be needed before 
EPA rules on the petition.

A. Residue Chemistry

    1. Plant metabolism. The qualitative nature of the residues in 
plants and animals 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.
    3. Magnitude of residues. Sweet corn at 14 locations throughout the 
major sweet corn-growing regions of the United States were treated with 
Poast herbicide, in order to determine the magnitude of the residue in 
or on sweet corn RAC samples. The applications were applied over the 
top of the ``sethoxydim-resistant'' hybrid corn plants at the target 
rate of 0.3 pounds active ingredient per acre (lb ai/A) in two 
sequential applications, for a maximum seasonal rate of 0.6 lb ai/A. 
There was a 10-day target interval between applications, with the last 
application occurring 30 days prior to the anticipated fresh corn 
harvest date.
    Fresh corn, forage, and stover samples were analyzed by common 
moiety methods that determine both parent plus metabolites. The highest 
individual total residues as parent equivalent for fresh corn, forage, 
and stover were 0.36, 2.67, and 3.32 ppm, respectively. The residue 
decline site showed trends in decreasing residues with increasing pre-
harvest intervals (PHI) in fresh corn and forage. There was no decline 
trend for stover as residues remained somewhat consistent through the 
71-91 DALA sampling.

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 follows:
    i. Acute oral toxicity, rat. Toxicity Category III; lethal dose 
(LD50) = 3,125 milligrams/kilogram (mg/kg) (male), 2,676 mg/
kg (female).
    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 mg/L (male), 6.28 mg/L 
(female).
    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% 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, and 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).
    A developmental toxicity study in rabbits fed doses of 0, 80, 160, 
320, and 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 (HTD).
    A 2-generation reproduction study with rats fed diets containing 0, 
150, 600, and 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 
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, and 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.

[[Page 57596]]

    iii. A 2-year chronic feeding/carcinogenic study with rats fed 
diets containing 0, 2, 6, and 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.
    iv. A second chronic feeding/carcinogenic study with rats fed diets 
containing 0, 360, and 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 weight 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 hydroxy-
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. 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.)
    i. Food. The TMRC from existing tolerances for the overall U.S. 
population is estimated at approximately 44% of the RfD. BASF estimates 
indicate that dietary exposure will not exceed the RfD 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. Based on the available studies submitted to EPA 
for assessment of environmental risk, BASF does not anticipate 
exposures to residues of sethoxydim in drinking water. There is no 
established Maximum Concentration Level (MCL) for residues of 
sethoxydim in drinking water under the Safe Drinking Water Act (SDWA).
    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 active ingredient 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--Reference dose (RfD). Using the conservative 
exposure assumptions described above, BASF has estimated that aggregate 
exposure to sethoxydim will utilize 44% of the RfD for the U.S. 
population. EPA generally has no concern for exposures below 100% of 
the RfD. 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 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, and 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 Agency has considered this study usable 
for regulatory purposes and has established a free-standing NOAEL of 
3,000 ppm (approximately 150 mg/kg/day) (60 FR 13941).
    iii. Reference dose. Based on the demonstrated lack of significant 
developmental or reproductive toxicity, BASF believes that the RfD used 
to

[[Page 57597]]

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. BASF calculates the 
exposure to this group to be approximately 95% of the RfD 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

    There are no Codex or Mexican maximum residue limits or tolerances 
for sethoxydim on sweet corn. There is a Canadian tolerance on corn of 
0.5 ppm for sethoxydim and metabolites containing the cyclohex-2-enone 
moiety expressed as sethoxydim.

[FR Doc. 02-23088 Filed 9-10-02; 8:45 am]
BILLING CODE 6560-50-S