[Federal Register Volume 60, Number 70 (Wednesday, April 12, 1995)]
[Rules and Regulations]
[Pages 18543-18546]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-8731]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[PP 9F3855, 2F4121, 4F4413/R2121; FRL-4947-2]
RIN 2070-AB78
Sethoxydim; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This document establishes a pesticide tolerance for the
combined residues of the herbicide 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
commodities (RACs) clover forage at 35 parts per million (ppm), clover
hay at 50 ppm, almond hulls at 2.0 ppm and the crop groupings tree nuts
at 0.2 ppm and cucurbit vegetables at 4.0 ppm. The BASF Corp. requested
these regulations to establish maximum permissible levels for residues
of the pesticide in or on the above commodities and crop groupings.
EFFECTIVE DATE: April 12, 1995.
ADDRESSES: Written objections and hearing requests, identified by the
document control number, [PP 9F3855, 2F4121, 4F4413/R2121], may be
submitted to: Hearing Clerk (1900), Environmental Protection Agency, Rm
M3708, 401 M St., SW., Washington, DC 20460. A copy of any objections
and hearing requests filed with the Hearing Clerk should be identified
by the document control number and submitted 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 [[Page 18544]] copy of
objections and hearing request to: Rm. 1132, CM #2, 1921 Jefferson
Davis Hwy., Arlington, VA 22202. Fees accompanying objections shall be
labeled ``Tolerance Petition Fees'' and forwarded to: EPA Headquarters
Accounting Operations Branch, OPP (Tolerance Fees), P.O. Box 360277M,
Pittsburgh, PA 15251.
FOR FURTHER INFORMATION CONTACT: By mail, Robert J. Taylor, Product
Manager (PM 25), Registration Division (7505C), Office of Pesticide
Programs, Environmental Protection Agency, 401 M St., SW., Washington,
DC 20460. Office location and telephone number: Rm. 241, CM #2, 1921
Jefferson Davis Hwy., Arlington, VA 22202, (703)-305-6027; e-mail:
taylor.robert@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: EPA has issued notices in the Federal
Register announcing that BASF Corp., P.O. Box 13528, Research Triangle
Park, NC 27709-3528, had submitted pesticide petitions to EPA proposing
to amend 40 CFR part 180 pursuant to section 408(d) of the Federal
Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), establishing
regulations to permit the combined residues of the herbicide 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 certain RACs.
1. PP 9F3855. Published in the Federal Register of June 29, 1990
(54 FR 26751), the notice proposed establishing a regulation to permit
residues of the herbicide on tree nuts at 0.2 ppm and almond hulls at
2.0 ppm.
2. PP 2F4121. Published in the Federal Register of December 30,
1992 (57 FR 62334), the notice proposed establishing a regulation to
permit residues of the herbicide on clover.
3. PP 4F4413. Published in the Federal Register of February 8, 1995
(60 FR 7541), the notice proposed establishing a regulation to permit
residues of the herbicide on the crop grouping cucurbit vegetables at
4.0 ppm.
No comments were received in response to the notices of filing.
The filing notice for PP 2F4121 should have proposed establishing a
regulation to permit residues of the herbicide in or on clover forage
at 35 ppm and clover hay at 50 ppm. Because clover forage and hay are
animal feeds, not human foods, and current tolerances in livestock
commodities will not be exceeded as a result of the proposed tolerances
on clover forage and hay, there is no potential increase risk to
humans. Therefore, an additional period of public comment is not
necessary.
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 that 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% a.i.).
2. A 21-day dermal study with rabbits fed dosages of 0, 40, 200,
and 1,000 mg/kg/day with a NOAEL (no-observed-adverse-effect level) of
greater than 1,000 mg/kg/day (limit dose).
3. A 1-year feeding study with dogs fed dosages (based on
consumption) of 0, 8.86/9.41, 17.5/19.9, and 110/129 mg/kg/day (males/
females) with a NOEL (no-observed-effect level) of 8.86/9.41 mg/kg/day
(males/ females) based on equivocal anemia in males and females at
17.5/19.9 mg/kg/day, respectively.
4. A 2-year chronic feeding/carcinogenicity study with mice fed
dosages of 0, 6, 18, 54, and 162 mg/kg/day with no carcinogenic effects
observed under the conditions of the study at dose levels up to and
including 162 mg/kg/day (highest dose tested [HDT]) and a systemic NOEL
of 18 mg/kg/day. A maximum tolerated dose (MTD) was not achieved for
females in this study. A determination of the need for an additional
study will be made once the replacement chronic feeding/carcinogenicity
study in rats is evaluated.
5. A 2-year chronic feeding/carcinogenic study with rats fed
dosages of 0, 2, 6, and 18 mg/kg/day (HDT) with no carcinogenic effects
observed under the conditions of the study at dosage levels up to and
including 18 mg/kg/day (HDT) and a systemic NOEL greater than or equal
to 18 mg/kg/day (HDT). 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 a maximum tolerated dose
(MTD) was not achieved. This study must be repeated.
6. A chronic feeding/carcinogenic study with rats was submitted to
supplement the above study. Rats in this study were fed dosages of 0,
18.2/23.0, and 55.9/71.8 mg/kg/day (males/females) with no carcinogenic
effects observed under the conditions of the study at dose levels up to
and including 55.9/71.8 mg/kg/day (HDT) (males/females) and a systemic
NOEL greater than or equal to 55.9/71.8 mg/kg/day (males/females). The
doses used were insufficient to induce a toxic response and failed to
achieve an MTD or define a Lowest Effect Level (LEL). Slight decreases
in body weights in the final quarter of the study, although not
biologically significant, can support a free-standing NOAEL of 55.9/
71.8 mg/kg/day (males/females). A new study is necessary to replace
both this study and the one discussed above.
7. 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% 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).
8. 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 lowest- observable-effect level (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 (HDT).
9. A two-generation reproduction study with rats fed dosage levels
of 0, 150, 600, and 3,000 ppm (approximately 0, 7.5, 30, and 150 mg/kg/
day) with no reproductive effects observed at 3,000 ppm (approximately
150 mg/kg/day) (HDT). However, 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).
10. Mutagenicity studies included: Ames Assays which were negative
for Salmonella typhimurium strains TA98, TA100, TA1535, and TA 1537,
with and without metabolic activity; sethoxydim did not cause
structural chromosomal aberrations at doses up to 5,000 mg/kg in
Chinese hamster bone marrow cells in vivo; a Host-Mediated Assay
(mouse) with S. typhimurium was negative at 2.5 grams/kg/day of
chemical, and recombinant assays and forward mutations in Bacillus
subtilis, Escherichia coli, and S. typhimurium were all negative at
concentrations of greater than or equal to 100%; an in vitro
Unscheduled DNA Synthesis [[Page 18545]] Assay in Primary Rat
Hepatocytes had a negative response for DNA repair (UDS) in primary rat
hepatocyte cultures exposed up to insoluble (greater than 101
micrograms per milliliter) and cytotoxic (507 micrograms per
milliliter) doses.
11. In a rat metabolism study, excretion was extremely rapid and
tissue accumulation was negligible, assuming DMSO vehicle does not
affect excretion or storage of NP-55 (78% excreted into urine and 20.1%
into feces).
The reference dose (RFD) based on a NOEL of 8.86 mg/kg bwt/day in
the 1-year feeding study in dogs and an uncertainty factor of 100 was
calculated to be 0.09 mg/kg bwt/day. The theoretical maximum residue
contribution (TMRC) for existing tolerances for the overall U. S.
population is 0.032341 mg/kg bwt/day or 35.9% of the RfD. The current
action will increase the TMRC by 0.000563 mg/kg bwt/day. These
tolerances and previously established tolerances utilize a total of
36.5 percent of the RfD for the overall U.S. population. For U.S.
subgroup populations, nonnursing infants and children aged 1 to 6, the
current action and previously established tolerances utilize,
respectively, a total of 62.75 percent and 73.5 percent of the ADI,
assuming that residue levels are at the established tolerances and that
100 percent of the crop is treated.
Cross Reference Note: These studies are also referenced in an EPA
proposed rule on sethoxydim appearing in the ``Proposed Rules'' section
of this issue of the Federal Register.
Desirable data lacking based on review of data under current
guidelines include a repeat of the chronic feeding/carcinogenicity
study in rats. Once the rat study is evaluated, a repeat of the mouse
carcinogenicity study may be needed. Because the current studies,
although unacceptable by current guidelines, provide useful information
and these tolerances utilize less than 1 percent of the RfD, the Agency
believes there is little risk from establishing these tolerances. Any
additional tolerance proposals will be considered on a case-by-case
basis.
The pesticide is useful for the purposes for which these tolerances
are sought and capable of achieving the intended physical or technical
effect. The nature of the residue is adequately understood, and
adequate analytical methods, gas chromatography using sulfur-specific
flame photometric detection, are available for enforcement purposes.
The method for tree nuts and cucurbits is listed in the Pesticide
Analytical Manual, Vol. II (PAM II), as Method I. The analytical
methods for clover forage and hay are revisions of the above method.
Because of the long lead time from establishing these tolerances until
publication, the enforcement methodology for clover forage and hay is
being made available in the interim to anyone interested in pesticide
enforcement when requested by mail from: Calvin Furlow, Public Response
and Program Resources Branch, Field Operations Division (7506C), Office
of Pesticide Programs, Environmenal Protection Agency, 401 M St., SW.,
Washington, DC 20460. Office location and telephone number; Rm. 1130A,
CM #2, 1921 Jefferson Davis Hwy., Arlington VA 22202.
There are currently no actions pending against the registration of
this chemical. Any expectation of residues occurring in eggs, milk,
meat, fat, or meat byproducts of cattle, goats, hogs, horses, and sheep
or poultry will be covered by existing tolerances.
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, EPA is establishing the
tolerances as set forth below.
Any person adversely affected by this regulation may, within 30
days after publication of this document in the Federal Register, file
written objections with the Hearing Clerk, at the address given above.
40 CFR 178.20. A copy of the objections and/or hearing requests filed
with the Hearing Clerk should be submitted to the OPP docket for this
rulemaking. The objections submitted must specify the provisions of the
regulation deemed objectionable and the grounds for the objections. 40
CFR 178.25. Each objection must be accompanied by the fee prescribed by
40 CFR 180.33(i). If a hearing is requested, the objections must
include a statement of the factual issue(s) on which a hearing is
requested, the requestor`s contentions on each such issue, and a
summary of any evidence relied upon by the objector. 40 CFR 178.27. A
request for a hearing will be granted if the Administrater determines
that the material submitted shows the following: There is a genuine and
substantial issue of fact; there is a reasonable possibility that
available evidence identified by the requestor would, if established,
resolve one or more of such issues in favor of the requestor, taking
into account uncontested claims or facts to the contrary; and
resolution of the factual issue(s) in the maner sought by the requestor
would be adequate to justify the action requested. 40 CFR 178.32.
Under Executive Order 12866 (58 FR 51735, October 4, 1993), the
Agency must determine whether the regulatory action is ``significant''
and therefore subject to review by the Office Of Management and Budget
(OMB) and the requirements of the Executive Order. Under section 3(f),
the order defines a ``significant regulatory action'' as an action that
is likely to result in 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 referred to 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 the rights and obligation of recipients
thereof; 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 the 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: March 30, 1995.
Stephen L. Johnson,
Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR part 180 is 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.
[[Page 18546]] 2. In Sec. 180.412, by revising the section heading
and introductory texts of paragraphs (a) and (b) and by amending
paragraph (a) in the table therein by adding and alphabetically
inserting new entries for almond hulls; clover, forage; clover, hay;
and tree nuts and by revising the entry for cucurbits vegetables, 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
commodities:
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Almond hulls............................................... 2.0
* * * *
Clover, forage............................................. 35.0
Clover, hay................................................ 50.0
* * * * *
Cucurbits vegetables....................................... 4.0
* * * * *
Tree nuts.................................................. 0.2
* * * * *
------------------------------------------------------------------------
(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
commodities:
* * * * *
[FR Doc. 95-8731 Filed 4-11-95; 8:45 am]
BILLING CODE 6560-50-F
