[Federal Register Volume 62, Number 5 (Wednesday, January 8, 1997)]
[Notices]
[Pages 1114-1117]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-415]


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ENVIRONMENTAL PROTECTION AGENCY
[PF-688; FRL-5582-6]


Interregional Research Project Number 4; Pesticide Tolerance 
Petitions Filing

AGENCY: Environmental Protection Agency (EPA).

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SUMMARY: This notice announces the filing of amendments to pesticide 
petitions 0E3909, 2E4052, 2E4065, 2E4092, and 3E4162. These amendments 
propose to extend the effective date for time-limited tolerances 
established for the combined residues of the herbicide 2-[1-
(ethoxyimino)butyl]-5-[2-(ethylthio)propyl]-3-hydroxy-2-cyclohexen-1-
one (also referred to in this document as sethoxydim) and its 
metabolites in or on various raw agricultural commodities. This notice 
contains a summary of the amended petition prepared by BASF Corporation 
(BASF) and submitted by the Interregional Research Project Number 4 
(IR-4), the petitioner.
DATES: Comments, identified by the docket number [PF-688; FRL-5582-6], 
must be received on or before February 7, 1997.

ADDRESSES: By mail, submit written comments to Public Response and 
Program Resources Branch, Field Operations Division (7506C), Office of 
Pesticide Programs, Environmental Protection Agency, 401 M. St. SW.,

[[Page 1115]]

Washington, DC 20460. In person, bring comments to Rm. 1132, CM #2, 
1921 Jefferson Davis Highway, Arlington, VA 22202. Comments and data 
may also be submitted electronically by sending electronic mail (e-
mail) to: [email protected]. Electronic comments on this 
notice may also be filed online at many Federal Depository Libraries.
    Information submitted as comments concerning this document may be 
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 4:00 p.m., Monday through Friday, excluding legal 
holidays.
    Comments and data may also be submitted electronically by sending 
electronic mail (e-mail) to: OPP-D[email protected]. 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 in 5.1 file format or ASCII file 
format. All comments and data in electronic form must be identified by 
the docket number PF-688. No CBI should be submitted through e-mail. 
Electronic comments on this proposed rule may be filed online at many 
Federal Depository Libraries. Additional information on electronic 
submissions can be found in Unit III of this document.

FOR FURTHER INFORMATION CONTACT: By mail: Hoyt L. Jamerson, 
Registration Division (7505W), Office of Pesticide Programs, 
Environmental Protection Agency, 401 M St. SW., Washington, DC 20460. 
Office location and telephone number: Sixth Floor, Crystal Station #1, 
2800 Jefferson Davis Highway, Arlington, VA 22202, (703) 308-8783, e-
mail:[email protected].
SUPPLEMENTARY INFORMATION: EPA has received amendments to pesticide 
petitions 0E3909, 2E4052, 2E4065, 2E4092, and 3E4162 from the 
Interregional Research Project No. 4 (IR-4), New Jersey Agricultural 
Experiment Station, P.O. Box 231, Rutgers University, New Brunswick, NJ 
08903. These amendments propose, pursuant to section 408 of the Federal 
Food, Drug and Cosmetic Act (FFDCA), 21 U.S.C. 346a, to amend 40 CFR 
part 180 by extending the effective date to expire on December 31, 
1998, for time-limited tolerances established for residues of the 
herbicide 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 asparagus at 4.0 parts 
per million (ppm), carrot at 1.0 ppm, cranberry and endive at 2.0 ppm, 
and peppermint and spearmint at 30 ppm. Registration for use of 
sethoxydim on endive is limited to Florida based on the geographical 
representation of the residue data submitted. Additional residue data 
will be required to expand the area of usage. Persons seeking 
geographically broader registration should contact the Agency's 
Registration Division at the address provided above.
    EPA has determined that the amendment 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 supports granting of the petition. Additional data 
may be needed before EPA rules on the petition.
    The nature of the residue is adequately understood, and practical 
and adequate analytical methods are available for enforcement purposes. 
Enforcement methods for sethoxydim are listed in the Pesticide 
Analytical Manual, Volume II (PAM II). Enforcement methods have also 
been submitted to the Food and Drug Administration for publication in 
PAM II.
    As required by section 408(d) of the FFDCA, as recently amended by 
the Food Quality Protection Act, IR-4 submitted a summary of amendments 
to the pesticide petitions and authorization for the summary to be 
published in the Federal Register in a notice of receipt of the 
petition. The summary was prepared by and represents the views of BASF; 
EPA, as mentioned above, is in the process of evaluating the petition. 
As required by section 408(d)(3) EPA is including the summary as a part 
of this notice of filing. EPA may have made minor edits to the summary 
for the purpose of clarity.

I. Petition Summary

A. Toxicological Profile

    1. Data summary. A summary of toxicological studies for sethoxydim 
follows:
    i. A 1-year feeding study with dogs fed diets containing 0, 8.86/
9.41, 17.5/19.9, and 110/129 milligrams (mg)/kilogram (kg)/day (males/
females) with a no-observed-effect-level (NOEL) 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 NOEL 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, and 18 mg/kg/day with a systemic NOEL greater 
than or equal to 18 mg/kg/day (highest dose tested). 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 lowest effect level (LEL). Slight decreases in body weight in 
rats at the 1,080-ppm dose level, although not biologically 
significant, support a free-standing no-observed-adverse-effect-level 
(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.
    v. A developmental toxicity study in rats fed dosages of 0, 50, 
180, 650, and 1,000 mg/kg/day with a maternal NOAEL of 180 mg/kg/day 
and a maternal LEL 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 LEL of 650 mg/
kg/day (21 to 22 percent 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).
    vi. A developmental toxicity study in rabbits fed doses of 0, 80, 
160, 320, and 400 mg/kg/day with a maternal NOEL of 320 mg/kg/day and a 
maternal LOEL of 400 mg/kg/day (37 percent reduction in

[[Page 1116]]

body weight gain without significant differences in group mean body 
weights and decreased food consumption during dosing); and a 
developmental NOEL greater than 400 mg/kg/day (highest dose tested).
    vii. 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.
    viii. Mutagenicity studies including: Ames assays were negative for 
gene mutation in Salmonella typhimurium strains TA98, TA100, TA1535, 
and TA1537, 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; and 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 percent.
    ix. In a rat metabolism study, excretion was extremely rapid and 
tissue accumulation was negligible.
    2. Chronic toxicity. Based on the available chronic toxicity data, 
EPA has established the Reference Dose (RfD) for sethoxydim at 0.09 
milligrams (mg)/kilogram (kg) bw/day. The RfD for sethoxydim is based 
on a 1-year feeding study in dogs with a threshold no-observed effect 
level (NOEL) of 8.86 mg/kg/day and an uncertainty factor of 100.
    3. Acute toxicity. Based on the available acute toxicity data, 
sethoxydim does not pose any acute dietary risks. Several acute 
toxicology studies place technical sethoxydim in acute toxicity 
category IV for primary eye and dermal irritation and acute toxicity 
category III for acute oral, dermal, and inhalation. The dermal 
sensitization-guinea pig study was waived because no sensitization was 
seen in guinea pigs dosed with the end-use product Poast (18 percent 
active ingredient).
    4. Carcinogenicity. These tolerances were established as time-
limited tolerances since an acceptable carcinogenicity study is needed 
in one rodent species. A repeat chronic feeding/carcinogenicity study 
in rats was submitted to EPA in November of 1995 and is awaiting 
review. The Agency will reassess sethoxydim tolerances based on the 
outcome of the rat chronic feeding/carcinogenicity study and, if 
appropriate, will establish permanent tolerances for asparagus, carrot, 
cranberry, endive, peppermint and spearmint. In the interim, there is 
little risk from the proposed time extension for these uses of 
sethoxydim, since available studies in rats and mice indicate no 
carcinogenic effects, there are adequate data to establish a RfD, 
existing tolerances (including these time-limited tolerances) do not 
exceed the RfD, and the tolerances for asparagus, carrot, cranberry, 
endive, and mint utilize less than 1 percent of the Reference Dose. 
Thus a cancer risk assessment is not necessary.

B. Aggregate Exposure

    For purposes of assessing the potential dietary exposure, BASF has 
estimated aggregate exposure based on the Theoretical Maximum Residue 
Contribution (TMRC) from the tolerances of sethoxydim on: asparagus at 
4.0 ppm, carrot at 1.0 ppm, cranberry and endive at 2.0 ppm, and 
peppermint and spearmint at 30.0 ppm. (The TMRC is a ``worst case'' 
estimate of dietary exposure since it is assumed that 100 percent 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 0.0311961 
mg/kg bw/day, or 36 percent of the RfD. Dietary exposure to residues of 
sethoxydim in or on asparagus, carrot, cranberry, endive and mint 
increases the TMRC by 0.000701 mg/kg bw/day and accounts for less than 
1 percent of the RfD for the overall U.S. population. EPA estimates 
indicate that dietary exposures will not exceed the RfD for any 
population subgroup for which EPA has data [See Proposed Rule at 60 FR 
13941, March 15, 1995]. This exposure assessment relies on very 
conservative assumptions--100 percent 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.
    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 used in EPA's 
assessment of environmental risk, BASF does not anticipate exposure 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).
    EPA has not estimated non-occupational exposure for sethoxydim. 
Sethoxydim is labeled for use by homeowners on the following use sites: 
flowers, evergreens, shrubs, trees, fruits, vegetables, ornamental 
ground covers, 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. Post-
treatment (re-entry) exposure would be negligible for these use sites 
as contact with treated surfaces would be low. Dietary risks from 
treated food crops are already adequately regulated by the established 
tolerances. The additional uses endive, asparagus , carrots, 
cranberries, peppermint, and spearmint will not increase the non-
occupational exposure appreciably, if at all. Thus, BASF believes that 
the potential for non-occupational exposure to the general population 
is insignificant.
    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.

C. Determination of Safety for U.S. Population

    Reference Dose (RfD). Using the conservative exposure assumptions 
described above, based on the completeness and the reliability of the 
toxicity data, EPA has estimated that aggregate exposure to sethoxydim 
will utilize 37 percent of the RfD for the U.S. population. EPA 
generally has no concern for exposures below 100 percent 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.

[[Page 1117]]

D. Determination of Safety for Infants and Children

    1. Developmental toxicity. Developmental toxicity was observed in a 
developmental toxicity study using rats but was not seen in a 
developmental toxicity study using rabbits. A developmental NOAEL of 
180 mg/kg/day and developmental LEL of 650 mg/kg/day were established 
for the rat study. Effects noted in the rat study included decrease in 
fetal weights (21 to 22 percent), filamentous tail, lack of tail (due 
to absence of sacral and/or caudal vertebrae), and delayed ossification 
(hyoids, vertebral centrum and/or transverse processes, sternebrae and/
or metatarsals, and pubes). The developmental NOEL for the rabbit study 
was greater than 400 mg/kg/day and was the highest dose tested. The 
developmental effects observed in the rat study are believed to be 
secondary effects resulting from maternal stress.
    2. Reproductive toxicity. A two-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 NOEL of 
3,000 ppm (approximately 150 mg/kg/day) [See Proposed Rule at 60 FR 
13941, March 15, 1995].
    RFD. Based on the demonstrated lack of significant developmental or 
reproductive toxicity BASF believes that the RfD 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. BASF calculates the exposure to this group to be 
less than 70 percent of the RfD for all uses (including those proposed 
in this document). The proposed tolerances in endive, asparagus, 
carrot, cranberry, peppermint and spearmint represent an exposure to 
this group of less than 1 percent. 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 dietary exposure and all other non-
occupational exposures.
    3. Endocrine effects. No special studies investigating potential 
estrogenic or endocrine effects of sethoxydim have been conducted. 
However, the standard battery of required 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 but no such effects were noted in any of the studies.

II. Other Considerations

    There is no reasonable expectation that secondary residues will 
occur in milk, eggs, or meat of livestock and poultry from the proposed 
uses of sethoxydim on asparagus, cranberries, endive, and mint; there 
are no livestock feed commodities associated with these commodities. 
Any secondary residues occurring in meat, fat, meat byproducts and milk 
of cattle, goats, hogs, horses and sheep from the proposed use on 
carrots will be covered by existing tolerances. There are no residues 
expected to occur in poultry meat, meat byproducts, fat or eggs since 
carrots are not considered a poultry feed item. There are no Codex 
maximum residue levels established for residues of sethoxydim on 
asparagus, carrots, cranberry, endive, or mint.

III. Public Record

    EPA invites interested persons to submit comments on this notice of 
filing. Comments must bear a notation indicating the docket number, 
[PF-688; FRL-5582-6]. All written comments filed in response to this 
petition will be available in the Public Response and Program Resources 
Branch, at the address given above from 8:30 a.m. to 4:00 p.m., Monday 
through Friday, except legal holidays.
    A record has been established for this rulemaking under docket 
number [PF-688; FRL-5582-6] (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 4:00 p.m., Monday through Friday, excluding legal 
holidays. The public record is located in Room 1132 of the Public 
Response and Program Resources Branch, Field Operations Division 
(7506C), Office of Pesticide Programs, Environmental Protection Agency, 
Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA.
    Electronic comments can be sent directly to EPA at:
    [email protected]


    Electronic comments must be submitted as an ASCII file avoiding the 
use of special characters and any form of encryption.
    The official record for this notice of filing, as well as the 
public version, as described above will be kept in paper form. 
Accordingly, EPA will transfer all comments received electronically 
into printed, paper form as they are received and will place the paper 
copies in the official rulemaking record which will also include all 
comments submitted directly in writing. The official rulemaking record 
is the paper record maintained at the address in ``ADDRESSES'' at the 
beginning of this document.

List of Subjects

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping.
    Authority: 21 U.S.C. 346a.

    Dated: December 31, 1996.

Stephen L. Johnson,

Director, Registration Division, Office of Pesticide Programs.

[FR Doc. 97-415 Filed 1-7-97; 8:45 am]
BILLING CODE 6560-50-F