[Federal Register Volume 60, Number 50 (Wednesday, March 15, 1995)]
[Proposed Rules]
[Pages 13941-13943]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-6419]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[PP 0E3909, 2E4052, 2E4065, 2E4092, and 3E4162/P602; FRL-4936-1]
RIN 2070-AC18
Pesticide Tolerances for 2-[1-(Ethoxyimino)Butyl]-5-[2-
(Ethylthio)Propyl]-3-Hydroxy-2-Cyclohexen-1-One
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: EPA proposes to establish time limited tolerances 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. The Interregional Research Project No. 4 (IR-
4) requested the proposed regulation to establish maximum permissible
levels for residues of the herbicide. These time-limited tolerances
would expire on December 31, 1996.
DATES: Comments, identified by the document control number [PP 0E3909,
2E4052, 2E4065, 2E4092, and 3E4162/P602], must be received on or before
April 14, 1995.
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.,
Washington, DC 20460. In person, bring comments to: Rm. 1132, CM #2,
1921 Jefferson Davis Hwy., Arlington, VA 22202.
Information submitted as a comment concerning this notice may be
claimed confidential by marking any part or all of that information as
``Confidential Business Information'' (CBI). Information so marked 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 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays.
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 Hwy., Arlington, VA 22202, (703)-308-8783.
SUPPLEMENTARY INFORMATION: The Interregional Research Project No. 4
(IR-4), New Jersey Agricultural Experiment Station, P.O. Box 231,
Rutgers University, New Brunswick, NJ 08903, has submitted pesticide
petitions (PP) 0E3909, 2E4052, 2E4065, 2E4092, and 3E4162 to EPA on
behalf of the named Agricultural Experiment Stations.
These petitions request that the Administrator, pursuant to section
408(e) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C.
346a(e), amend 40 CFR 180.412 by establishing time-limited tolerances
for combined 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 certain raw agricultural commodities as follows:
1. PP 0E3909. Petition submitted on behalf of the Experimental
Stations of Massachusetts, Washington, and [[Page 13942]] Wisconsin
proposing a tolerance for cranberry at 2.0 parts per million (ppm).
2. PP 2E4052. Petition submitted on behalf of the Experimental
Stations of South Dakota and Washington proposing tolerances for
peppermint and spearmint at 30 ppm.
3. PP 2E4065. Petition submitted on behalf of the Experimental
Station of Florida proposing a tolerance for endive at 2.0 ppm. The
petitioner proposed that use of sethoxydim on endive be 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.
4. PP 2E4092. Petition submitted on behalf of the Experimental
Stations of California, Florida, Maryland, Michigan, New Jersey, North
Carolina, and Tennessee proposing a tolerance for carrot at 1.0 ppm.
5. PP 3E4162. Petition submitted on behalf of the Experimental
Stations of Arkansas, Arizona, Michigan, North Carolina, Oklahoma, and
Washington proposing a tolerance for asparagus at 4.0 ppm.
The scientific data submitted in the petitions and other relevant
material have been evaluated. The toxicological data considered in
support of the proposed tolerances include:
1. 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 a.i.).
2. 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.
3. 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.
4. 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.
5. 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.
6. 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).
7. 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% reduction in 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).
8. 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) with no reproductive effects observed under the
conditions of the study.
Although the dose levels were insufficient to elicit a toxic
response, the Agency considers this study usable for regulatory
purposes and has established a free-standing NOEL of 3,000 ppm
(approximately 150 mg/kg/day).
9. Mutagenicity studies including: 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; 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.
10. In a rat metabolism study, excretion was extremely rapid and
tissue accumulation was negligible.
The reference dose (RFD) is calculated at 0.09 mg/kg of body
weight/day, based on a NOEL of 8.86 mg/kg/day from the 1-year feeding
study in dogs and an uncertainty factor of 100. The theoretical maximum
residue contribution (TMRC) from existing tolerances for the overall
U.S. population is estimated at 0.031961 mg/kg of body weight/day, or
36% of the RfD. The proposed tolerances for asparagus, carrot,
cranberry, endive, peppermint, and spearmint will increase the TMRC by
0.000701 mg/kg of body weight/day and will utilize less than 1 percent
of the RfD for the overall U.S. population. EPA estimates indicate that
dietary exposure will not exceed the RfD for any population subgroup
for which EPA has data.
These tolerances are proposed as time-limited tolerances since an
acceptable carcinogenicity study is needed in one rodent species. A
repeat chronic feeding/carcinogenicity study in rats is underway and is
due to be submitted to EPA in November of 1995. 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, the Agency concludes that
there is little risk from establishment of the proposed tolerances
since available studies in rats and mice indicate no carcinogenic
effects, there are adequate data to establish a RfD, existing
tolerances and the proposed tolerances do not exceed the RfD, and the
proposed tolerances utilize less than 1 percent of the RfD.
The nature of the residue is adequately understood, and adequate
analytical methods are available for enforcement purposes. Enforcement
methods for sethoxydim are listed in the Pesticide Analytical Manual,
Vol. II (PAM II). Enforcement methods have [[Page 13943]] also been
submitted to the Food and Drug Administration for publication in PAM
II. Because of the long lead time for publication of the analytical
methods in PAM II, the analytical methods are being made available in
the interim to anyone interested in pesticide enforcement when
requested from: Calvin Furlow, Public Response and Program Resources
Branch, Field Operations Divisions (7506C), Office of Pesticide
Programs, Environmental Protection Agency, 401 M St., SW., Washington,
DC 20460. Office location and telephone number: Rm. 1132, CM #2, 1921
Jefferson Davis Hwy., Arlington, VA 22202, (703)-305-5937.
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 items 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.
Based on the information and data considered, the Agency has
determined that the tolerances established by amending 40 CFR part 180
would protect the public health. Therefore, it is proposed that the
tolerances be established as set forth below.
Any person who has registered or submitted an application for
registration of a pesticide, under the Federal Insecticide, Fungicide,
and Rodenticide Act (FIFRA) as amended, which contains any of the
ingredients listed herein, may request within 30 days after publication
of this document in the Federal Register that this rulemaking proposal
be referred to an Advisory Committee in accordance with section 408(e)
of the FFDCA.
Interested persons are invited to submit written comments on the
proposed regulation. Comments must bear a notation indicating the
document control number, [PP 0E3909, 2E4052, 2E4065, 2E4092, and
3E4162/P602]. All written comments filed in response to these petitions
will be available in the Public Response and Program Resources Branch,
at the address given above from 8 a.m. to 4 p.m., Monday through
Friday, except legal holidays.
Under Executive Order 12866 (58 FR 51735, Oct. 4, 1993), the Agency
must determine whether the regulatory action is ``significant'' and
therefore subject to all the requirements of the Executive Order (i.e.,
Regulatory Impact Analysis, review by the Office of Management and
Budget (OMB)). Under section 3(f), the order defines ``significant'' as
those actions likely to lead to a rule (1) having an annual effect on
the economy of $100 million or more, or adversely and materially
affecting a sector of the economy, productivity, competition, jobs, the
environment, public health or safety, or State, local or tribal
governments or communities (also known as ``economically
significant''); (2) creating serious inconsistency or otherwise
interfering with an action taken or planned by another agency; (3)
materially altering the budgetary impacts of entitlement, grants, user
fees, or loan programs; or (4) raising novel legal or policy issues
arising out of legal mandates, the President's priorities, or the
principles set forth in this Executive Order.
Pursuant to the terms of this Executive Order, EPA has determined
that this rule is not ``significant'' and is therefore not subject to
OMB review.
Pursuant to the requirements of the Regulatory Flexibility Act
(Pub. L. 96-354, 94 Stat. 1164, 5 U.S.C. 601-612), the Administrator
has determined that regulations establishing new tolerances or raising
tolerance levels or establishing exemptions from tolerance requirements
do not have a significant economic impact on a substantial number of
small entities. A certification statement to this effect was published
in the Federal Register of May 4, 1981 (46 FR 24950).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: February 28, 1995.
Stephen L. Johnson,
Director, Registration Division, Office of Pesticide Programs.
Therefore, it is proposed that 40 CFR part 180 be amended as
follows:
PART 180--[AMENDED]
1. The authority citation for part 180 continues to read as
follows:
Authority: 21 U.S.C. 346a and 371.
2. In Sec. 180.412, by revising the section heading and the
introductory text of paragraphs (a) and (b) to correct the spelling of
the chemical name and by adding new paragraphs (c) and (d), to read as
follows:
Sec. 180.412 2-[1-(Ethoxyimino)butyl]-5-[2-(ethylthio)propyl]-3-
hydroxy-2-cyclohexen-1-one; tolerances for residues.
(a) Tolerances are established for the combined 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 the following raw
agricultural commodities:
* * * * *
(b) Tolerances with regional registration, as defined in
Sec. 180.1(n), are established for the combined 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 the following raw
agricultural commodities:
* * * * *
(c) Time-limited tolerances to expire December 31, 1996, are
established for combined 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 the following raw agricultural
commodities:
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Asparagus.................................................. 4.0
Carrot..................................................... 1.0
Cranberry.................................................. 2.0
Peppermint................................................. 30.0
Spearmint.................................................. 30.0
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(d) Time-limited tolerances to expire December 31, 1996, are
established with regional registration, as defined in Sec. 180.1(n),
for combined 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 the following raw agricultural commodities:
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Endive..................................................... 2.0
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[FR Doc. 95-6419 Filed 3-14-95; 8:45 am]
BILLING CODE 6560-50-F
