[Federal Register Volume 60, Number 13 (Friday, January 20, 1995)]
[Rules and Regulations]
[Pages 4097-4099]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-1500]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 180 and 186
[PP 2F4041, FAP 2H5621/R2103; FRL-4931-2]
RIN 2070-AB78
Pesticide Tolerance and Feed Additive Regulation for Sethoxydim
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
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-cyclohexene-1-one), and its
metabolites containing the 2-cyclohexene-1-one moiety (calculated as
the herbicide) in or on the raw agricultural commodity (RAC) canola/
rapeseed at 35.0 parts per million (ppm) and a feed additive regulation
in or on animal feed commodity canola/rapeseed meal at 40 ppm. BASF
Corp. requested these regulations to establish maximum permissible
levels for residues of the pesticide in or on the commodities.
EFFECTIVE DATE: This regulation becomes effective January 20, 1995.
ADDRESSES: Written objections and hearing requests, identified by the
document control number, [PP 2F4041, FAP 2H5261/R2103], may be
submitted to: Hearing Clerk (1900), Environmental Protection Agency,
Rm. M3708, 401 M St., SW., Washington, DC 20460. A copy of objections
and hearing request 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 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 36277M, 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. 245, CM #2, 1921
Jefferson Davis Hwy., Arlington, VA 22202, (703) 305-6800.
SUPPLEMENTARY INFORMATION: EPA issued a notice, published in the
Federal Register of March 11, 1992 (57 FR 8658), which announced that
BASF Corp., P.O. Box 13528, Research Triangle Park, NC 27709-3528, had
submitted pesticide petition (PP) 2F4041. EPA issued a notice,
published in the Federal Register of June 10, 1992 (57 FR 24646) that
the company had submitted feed additive petition (FAP) 2H5621. PP
2F4041 requests that the Administrator, pursuant to section 408(d) of
the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d),
amend 40 CFR part 180 by establishing a tolerance for the combined
residues of the herbicide sethoxydim, 2-[1-ethoxyimino)butyl]-5-[2-
(ethylthio) propyl]-3-hydroxy-2-cyclohexene-1-one) and its metabolites
containing the 2-cyclohexene-1-one moiety (calculated as the herbicide)
in or on the raw agricultural commodity (RAC) canola/ rapeseed at 35.0
parts per million. FAP 2H5621 requests that the Administrator, pursuant
to section 409(e) of the FFDCA (21 U.S.C. 348(e)), amend 40 CFR part
186 by establishing a feed additive regulation for combined residues of
the herbicide sethoxydim, 2-[1-ethoxyimino)butyl]-5-[2-
(ethylthio)propyl]-3-hydroxy-2cyclohexene-1-one), and its metabolites
containing the 2-cyclohexene-1-one moiety (calculated as the herbicide)
in or on animal feed commodity canola/rapeseed meal at 40 ppm.
No comments were received in response to these notices of filing.
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 placing 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 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.
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
[[Page 4098]] were insufficient to induce a toxic response and a
maximum tolerated dose (MTD) was not achieved. This study must be
repeated.
6. In a second supplemental chronic feeding/carcinogenic study with
rats 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).
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 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).
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
percent 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 4S. 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%; a in vitro Unscheduled
DNA Synthesis 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 (mL)) and
cytotoxic (507 ug/mL) 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 percent excreted into urine
and 20.1 percent excreted in 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 the overall U. S. population is 0.031961 mg/kg
bwt/day or 35.9% of the RfD for existing tolerances for the overall use
population. The current action will increase the TMRC by 0.000380 mg/kg
bwt/day. These tolerances and previously established tolerances utilize
a total of 35.9 percent of the ADI 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 61.8 percent and 72.6 percent of the ADI,
assuming that residue levels are at the established tolerances and that
100 percent of the crop is treated.
Desirable data lacking based on review of data under current
guidelines include a carcinogenicity in mice study and a chronic
feeding/carcinogenicity in rats study. Because the current studies,
although unacceptable by current guidelines, provide useful information
and these tolerances utilize 3 percent of the RfD, the Agency believes
there is little risk from establishment of 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 is listed in the Pesticide Analytical Manual, Volume II (PAM
II), as Method I.
There are currently no actions pending against the registration of
this chemical. Any secondary residues occuring in meat, fat, meat
byproducts and milk of cattle, goats, hogs, horses and sheep will be
covered by existing tolerances. There are no residues expected to occur
in poultry meat, meat byproducts, fat, or eggs from these tolerances.
Based on the information and data considered, the Agency has
determined that the tolerances established by amending 40 CFR part 180
will protect the public health, and the establishment of a feed
additive regulation by amending 40 CFR part 185 will be safe.
Therefore, they are eablished as set forth below.
Any person adversely affected by this regulation may, within 30
days after the date of publication in the Federal Register, file
written objections with the Hearing Clerk, Environmental Protection
Agency, 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 obctions
submitted must specify the provisions of the regulation deemed
objectionable and the grounds for the objection. 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 sue(s) on which a hearing is requested, the
requestor's intentions on each issue, and a summary of any evidence
relied upon by the objector. 40 CFR 178.27. A request for hearing will
be granted if the Administrator determines at 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 aims or
facts to the contrary; and resolution of the factual issue(s) in the
manner sought by the requestor would be adequate to justify the action
requested. 40 CFR 178.32.
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 [[Page 4099]] an
annual effect of 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, or establishing or raising food additive
regulations 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 Parts 180 and 186
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Feed additive, Pesticides and pests,
Reporting and recordkeeping requirements.
Dated: January 6, 1995.
Stephen L. Johnson,
Director, Registration Division, Office of Pesticide Programs.
Therefore, chapter I of title 40 of the Code of Federal Regulations
is amended as follows:
PART 180--[AMENDED]
1. In part 180:
a. The authority citation for part 180 continues to read as
follows:
Authority: 21 U.S.C. 346a and 371.
b. In Sec. 180.412 by amending paragraph (a) in the table therein
by adding and alphabetically inserting the entry for the raw
agricultural commodity canola/rapeseed to read as follows:
Sec. 180.412 2-[1-(Ethoxyimino)butyl]-5-[2-(ethylthio)propyl]-3-
hydroxy-2-cyclohexene-1-one; tolerances for residues.
(a) * * *
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Canola/rapeseed............................................ 35.0
* * * * *
------------------------------------------------------------------------
* * * * *
PART 186--[AMENDED]
2. In part 186:
a. The authority citation for part 186 continues to read as
follows:
Authority: 21 U.S.C. 348.
b. In Sec. 186.2800 in the table therein by adding and
alphabetically inserting the entry for canola/rapeseed, to read as
follows:
Sec. 186.2800 2-[1-(Ethoxyimino)butyl]-5-[2-(ethylthio)propyl]-3-
hydroxy-2-cyclohexene-1-one.
* * * * *
------------------------------------------------------------------------
Parts per
Food million
------------------------------------------------------------------------
* * * * *
Canola/rapeseed............................................ 40.0
* * * * *
------------------------------------------------------------------------
[FR Doc. 95-1500 Filed 1-19-95; 8:45 am]
BILLING CODE 6560-50-F
