[Federal Register Volume 59, Number 119 (Wednesday, June 22, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-15081]
[[Page Unknown]]
[Federal Register: June 22, 1994]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300349; FRL-4871-4]
RIN 2070-AC18
N-(n-Octyl)-2-Pyrrolidone and N-(n-Dodecyl)-2-Pyrrolidone;
Tolerance Exemptions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This document establishes tolerance exemptions for residues of
N-(n-octyl)-2-pyrrolidone and N-(n-dodecyl)-2-pyrrolidone as inert
ingredients (solvents) applied to growing crops. These exemptions were
requested by NOR-AM Chemical Co.
EFFECTIVE DATE: This regulation becomes effective June 22, 1994.
ADDRESSES: Written objections, identified by the document control
number, [OPP-300349], 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: NOR-AM Chemical Co., Little Falls Centre
One, 2711 Centerville Rd., Wilmington, DE 19808, submitted pesticide
petitions (PPs) proposing to amend 40 CFR part 180 to establish a
tolerance exemption for residues of N-(n-octyl)-2-pyrrolidone (PP
1E3959) and N-(n-dodecyl)-2-pyrrolidone (PP 1E3960) as inert
ingredients (solvents) applied to growing crops. EPA issued a notice,
published in the Federal Register of March 23, 1994 (57 FR 13720),
announcing receipt of these petitions. No comments were received in
response to the notice.
Inert ingredients 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 to nontoxicity; the ingredient may or may not
be chemically active.
As part of the EPA policy statement on inert ingredients published
in the Federal Register of April 22, 1987 (52 FR 13305), the Agency set
forth a list of studies which would generally be used to evaluate the
risks posed by the presence of an inert ingredient in a pesticide
formulation. 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 these exemptions from tolerance include:
1. A 90-day oral toxicity study in the rat using N-(n-octyl)-2-
pyrrolidone with a no-observed-adverse-effect level (NOAEL) of 600 ppm
(53 mg/kg) and a lowest-observed-adverse-effect level (LOAEL) of 8,460
ppm. Effects observed include significantly increased absolute and
relative liver weights and mild hepatocellular hypertrophy.
2. A 90-day oral toxicity study in the dog using N-(n-octyl)-2-
pyrrolidone with a NOAEL of 30 mg/kg and a LOAEL of 90 mg/kg. Effects
observed include increased absolute and relative liver weights,
hepatocellular hypertrophy, and altered blood levels of liver enzymes.
3. A developmental toxicity study in the rat using N-(n-octyl)-2-
pyrrolidone with a maternal NOAEL of 50 mg/kg and a developmental NOAEL
of 200 mg/kg. At the developmental LOAEL of 800 mg/kg there was altered
growth and an increased incidence of wavy ribs.
4. A negative mutagenicity battery for N-(n-octyl)-2-pyrrolidone
including an Ames Test, Micronucleus Test, and TK Locus Test and
negative Ames and Micronucleus Tests for N-(n-dodecyl)-2-pyrrolidone.
5. An oncogenicity study on N-methyl pyrrolidone, a related
compound, was judged negative by reviewers in the Office of Pollution
Prevention and Toxics, EPA.
Residue data is generally not required for inert ingredient
exemptions from tolerance. In this case, worst-case residue
calculations were done based on the proposed uses. These calculations
indicated that a broad exemption could not be granted without
additional residue information because of the potential for high
dietary exposure. The petitioner therefore requested that the exemption
be modified to include only the use of these solvents in cotton
defoliant formulations containing thidiazuron and diuron as active
ingrdients. This yielded worstcase residue estimates of 735 ppm in
cotton seed, concentrating to 4,630 ppm in cottonseed oil. Consumption
of cottonseed oil in children, the subgroup with the highest exposure,
is .036355 gms/kg/day. This leads to an exposure of .18 mg/kg/day, with
a margin of exposure of 166 from the NOAEL in the 90 day dog study.
Residue information from thidiazuron as a cotton defoliant indicates
that actual residues for these inerts are expected to be orders of
magnitude below this worst-case estimate.
Based upon the above information and review of its use, EPA has
found that, when used in accordance with good agricultural practice,
these ingredients are useful and a tolerance is not necessary to
protect the public health. Therefore, EPA proposes that the exemptions
from the requirement of a tolerance be 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 or 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: June 2, 1994.
Daniel M. Barolo,
Acting Director, Office of Pesticide Programs.
2Therefore, 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.
2. In subpart D, by adding new Sec. 180.1130, to read as follows:
Sec. 180.1130 N-(n-octyl)-2-pyrrolidone and N-(n-dodecyl)-2-
pyrrolidone; exemptions from the requirement of a tolerance.
N-(n-octyl)-2-pyrrolidone and N-(n-dodecyl)-2-pyrrolidone are
exempt from the requirement of a tolerance when used as solvents in
cotton defoliant formulations containing thidiazuron and diuron as
active ingredients.
[FR Doc. 94-15081 Filed 6-21-94; 8:45 am]
BILLING CODE 6560-50-F
