[Federal Register Volume 59, Number 89 (Tuesday, May 10, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-11192]
[[Page Unknown]]
[Federal Register: May 10, 1994]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[PP 1E4031/R2058; FRL-4777-2]
RIN 2070-AB78
Pesticide Tolerance for 3-Dichloroacetyl-5-(2-Furanyl)-2,2-
Dimethyl-Oxazolidine (Mon 13900)
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This document establishes time-limited tolerances for residues
of MON 13900, 3-dichloroacetyl-5-(2-furanyl)-2,2-dimethyloxazolidine
(CAS Reg. No. 121776-33-8), when used as an inert ingredient (safener)
in or on field corn, grain and field corn, fodder and forage at 0.01
part per million (ppm). Monsanto Co. submitted a request to establish a
maximum permissible level for residues of the inert ingredient in or on
the commodities. These time-limited tolerances expire June 30, 1996.
EFFECTIVE DATE: This regulation becomes effective May 10, 1994.
ADDRESSES: Written objections and hearing requests, identified by the
document control number, [PP 1E4031/R2058], 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 copy of objections and hearing
requests 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: Tina Levine, Registration
Support Branch, Registration Division (7505W), Environmental Protection
Agency, 401 M St., SW., Washington, DC 20460. Office location and
telephone number: Westfield Building North, 6th floor, 2800 Crystal
Drive, Arlington, VA 22202, (703)-308-8393.
SUPPLEMENTARY INFORMATION:
I. Background
EPA is charged with administration of section 408 of the Federal
Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346. Section 408
authorizes EPA to establish tolerance levels and exemptions from the
requirements of a tolerance for residues of pesticide chemicals in or
on raw agricultural commodities.
Inert ingredients of pesticide chemicals are all ingredients that
are not active ingredients as defined in 40 CFR 162.3(c), and include,
but are not limited to, the following types of ingredients (except when
they have a pesticidal efficacy of their own): solvents such as
alcohols and hydrocarbons; surfactants such as polyoxyethylene polymers
and fatty acids; carriers such as clay and diatomaceous earth;
thickeners such as carrageenan and modified cellulose; wetting and
spreading agents; propellants in aerosol dispensers; and emulsifiers.
The term ``inert'' is not intended to imply nontoxicity; the ingredient
may or may not be chemically active.
A policy statement on inert ingredients published in the Federal
Register of April 22, 1987 (52 FR 13305), included data requirements
which were to be used to evaluate the risks posed by the presence of an
inert ingredient in a pesticide formulation. The minimal (``base set'')
data requirements for inert ingredients were listed in that policy
statement. It was also noted that, based upon the results of the ``base
set'' studies, the Agency may elect to require additional data such as
would be required under 40 CFR part 158 for an active ingredient.
Included among these additional requirements are residue chemistry data
which would support the establishment of a finite tolerance for the
residues of an inert ingredient in raw agricultural commodities and/or
processed foods.
In those cases where the toxicity of an inert ingredient is such
that exposure to the inert ingredient must be restricted to assure that
the use of the inert ingredient in a pesticide formulation does protect
the public health, EPA will propose to establish a tolerance for
residues of the inert ingredient on raw agricultural commodities.
II. Provisions of Rule
Monsanto Co., Suite 1100, 700 14th St., NW., Washington, DC 20005,
submitted pesticide petition (PP) 1E4031 proposing to amend 40 CFR part
180 by establishing a regulation to establish negligible (N) residue
tolerances for the safener MON 13900, 3-dichloroacetyl-5-(2-furanyl)-
2,2-dimethyloxazolidine, in or on field corn, grain at 0.01 ppm (N) and
field corn, fodder and forage at 0.01 ppm (N). A safener is a
herbicidal antidote that protects desirous crops while allowing the
herbicide to act on the intended weed targets. EPA issued a notice,
published in the Federal Register of November 24, 1993 (58 FR 62123),
announcing receipt of this petition. No comments were received in
response to the notice.
The data submitted in the petitions and other relevant material
have been evaluated. This inert ingredient is considered useful for the
purpose for which the tolerance is sought. Toxicological, ecological,
and environmental fate data were considered in evaluating this inert
ingredient for use in pesticides. The data considered in support of the
proposed tolerance include:
1. An acute rat oral toxicity study with an acute oral LD50 of
869 milligrams (mg)/kilogram (kg).
2. An acute rabbit dermal toxicity study with an acute dermal
LD50 estimated to be >5,000 mg/kg.
3. A rabbit eye irritation study in which MON 13900 is determined
to be a mild irritant to the ocular tissue of the rabbit.
4. An acute rat inhalation toxicity study with a 4-hour inhalation
LC50 of >2.3 mg/L, the highest attainable concentration.
5. A rabbit primary dermal irritation study indicating that MON
13900 is a negligible dermal irritant.
6. A dermal sensitization study in guinea pigs indicating the MON
13900 does not produce delayed contact hypersensitivity.
7. A 21-day repeated-dose dermal toxicity study in rats with a no-
observed effect level (NOEL) >1,000 mg/kg.
8. A 90-day rat oral toxicity study with a NOEL of 100 parts per
million (ppm) or 7 mg/kg/day.
9. A 90-day dog oral toxicity study with a NOEL of 5 mg/kg/day.
10. A rat developmental effects study with a NOEL for maternal
toxicity of 10 mg/kg/day and developmental toxicity of 10 mg/kg/day.
11. Mutagenicity studies including in vivo/in vitro unscheduled DNA
synthesis in rat hepatocytes, Gene Mutation in Cultured Chinese Hamster
Ovary Cells (CHO/HGPRT), In Vivo Micronucleus Assay in Mice were
negative. Salmonella typhimurium/mammalian microsome mutagenicity assay
with and without metabolic activation indicated that MON 13900 induced
a reproducible mutagenic response, but only at a high and precipitating
dose.
A reference dose (RfD) has been established for this chemical at
0.005 mg/kg/day. This is based on the 90-day feeding study in dogs with
a NOEL of 5.0 mg/kg/day, an uncertainty factor of 100 to account for
inter-species and intra-species extrapolation, and an additional
uncertainty factor of 10 to account for the extrapolation from
subchronic to chronic exposure. The theoretical worst-case maximum
residue contribution (TMRC) from the proposed tolerance is estimated to
be 0.0000034 mg/kg-bwt (bodyweight)/day for the overall U.S.
population, representing 0.07% of the RfD for MON 13900. The TMRC for
the most highly exposed subgroup, nonnursing infants less than 1 year,
is 0.0000009 mg/kg-bwt/day, or approximately 0.02% of the RfD.
This tolerance is being established as a time-limited tolerance
because the Agency does not have final data from two chronic feeding/
oncogenicity studies which are part of the toxicology data typically
required to be submitted in support of a tolerance request. These
studies will be required to be submitted to the Agency by June 30,
1995. When the Agency receives these chronic feeding/oncogenicity
studies it will reassess the tolerance.
Preliminary information from the registrant has indicated that Mon
13900 can cause an increase in liver tumors in both sexes of rats and
mice and an increase in lung tumors in female mice. The data are not
available for a complete risk assessment but, nevertheless, certain
conclusions can be reached. Based on the estimated exposure of
0.0000034 mg/kg/day, a rough estimate of the cancer potency from the
preliminary data, and the limited duration of this tolerance, any
potential cancer risk from this use would be negligible. Therefore, the
Agency does not believe that this time-limited tolerance poses
significant risks.
This tolerance will expire June 30, 1996. Residues not in excess of
these tolerances will not be considered actionable if a pesticide
containing this inert ingredient is legally applied during the term of
a conditional registration under the Federal Insecticide, Fungicide,
and Rodenticide Act (FIFRA) as amended and in accordance with the
acceptable labeling under a conditional registration. This tolerance
will be revoked if any data indicate such revocation is necessary to
protect the public health.
An analytical method for determination of the nature of the
residue, gas-liquid chromatography using an electron-capture detector,
has been reviewed by the Agency, and will be made available in the
Pesticide Analytical Manual, Vol. II (PAM II), for enforcement
purposes. In the interim, the method will be available at the address
given below. By mail: Calvin Furlow, Public Response and Program
Resources Branch, Field Operations Division (7506C), Office of
Pesticide Programs, Environmental 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, (703)-305-5937.
Based upon the above information considered by the Agency, the
amendment to 40 CFR part 180 to establish the tolerance would protect
the public health. Therefore, the tolerance is established 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 and/or request a hearing 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 such issues, 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 Administrator 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 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 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 obligations 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, Recording and
recordkeeping requirements.
Dated: April 29, 1994.
Douglas D. Campt,
Director, 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. By adding new Sec. 180.471 to subpart C, to read as follows:
Sec. 180.471 3-Dichloroacetyl-5-(2-furanyl)-2,2-dimethyloxazolidine;
tolerances for residues.
Tolerances, to expire June 30, 1996, are established for residues
of 3-dichloroacetyl-5-(2-furanyl)-2,2-dimethyloxazolidine (CAS Reg. No.
121776-33-8) when used as an inert ingredient (safener) in pesticide
formulations in or on the following raw agricultural commodities:
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Parts per
Commodity million Expiration date
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Corn, fodder (field)................... 0.01 June 30, 1996.
Corn, forage (field)................... 0.01 June 30, 1996.
Corn, grain (field).................... 0.01 June 30, 1996.
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[FR Doc. 94-11192 Filed 5-9-94; 8:45 am]
BILLING CODE 6560-50-F
