[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: 94-15077]
[[Page Unknown]]
[Federal Register: June 22, 1994]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300342; FRL-4866-1]
RIN 2070-AC18
Dimethyl Ether; Tolerance Exemption
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: This document proposes that dimethyl ether (CAS Reg. No. 115-
10-6) be exempted from the requirement of a tolerance when used as an
inert ingredient (aerosol propellant) in pesticide formulations applied
to animals. This proposed regulation was requested by DuPont Chemicals.
DATES: Comments, identified by the document control number, [OPP-
300342], must be received on or before July 22, 1994.
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, deliver comments to: Rm. 1128, Crystal
Mall, Building #2, 1921 Jefferson Davis Hwy., Arlington, VA 22202.
Information submitted as a comment concerning this document may be
claimed confidential by marking any part of 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 will be included in the public docket by the EPA without
prior notice. The public docket is available for public inspection in
Rm. 1128 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: Tina Levine, Registration
Support Branch, Registration Division (7505W), Office of Pesticide
Programs, Environmental Protection Agency, 401 M St., SW., Washington,
DC 20460. Office location and telephone number: 2800 Crystal Drive,
North Tower, Arlington, VA 22202, (703)-308-8393.
SUPPLEMENTARY INFORMATION: Du Pont Chemicals, Chestnut Run Plaza, P.O.
Box 80711, Wilmington, DE 19880-0711, submitted pesticide petition (PP)
1E3990 to EPA requesting that the Administrator, pursuant to section
408(e) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 346a(e),
propose to amend 40 CFR 180.1001(e) by establishing an exemption from
the requirement of a tolerance for dimethyl ether (DME) when used as an
aerosol propellant in pesticide formulations applied to animals.
Inert ingredients are all ingredients that are not active
ingredients as defined in 40 CFR 153.125, 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, spreading, and dispersing
agents; propellants in aerosol dispensers; microencapsulating agents;
and emulsifiers. The term ``inert'' is not intended to imply
nontoxicity; the ingredient may or may not be chemically active.
The data submitted in the petition and other relevant material have
been evaluated. 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. However, where it can be determined without
that data that the inert ingredient will present minimal or no risk,
the Agency generally does not require some or all of the listed studies
to rule on the proposed tolerance or exemption from the requirement of
a tolerance for an inert ingredient. The Agency has decided that no
data, in addition to that described below, for dimethyl ether will need
to be submitted. The rationale for this decision is described below:
1. A cardiac sensitization study in the dog with a no-observed-
adverse- effect level (NOAEL) of 100,000 parts per million and a
lowest-observed-adverse effect level (LOAEL) of 200,000 ppm.
2. A 4-hour acute inhalation toxicity study in the male rat with an
LC50 of 164,000 ppm.
3. No evidence of mutagenicity with and without metabolic
activation when exposed in a closed system to Salmonella strains at
concentrations determined in a cytotoxicity test.
4. A 2-week inhalation study in rats with a NOAEL of less than
10,000 ppm.
5. A 4-week inhalation study in hamsters showing changes in red
blood cell counts in females and decreased white blood cell counts in
both males and females and decreased body weight and relative spleen
weight in males with a NOAEL of 2,000 ppm.
6. A 13-week inhalation study in rats showing elevated neutrophil
counts in all test groups with a NOAEL of less than 1,000 ppm.
7. A 13-week inhalation study in hamsters showing decreased red
blood cell count and hemoglobin in males with a NOAEL of 5,000 ppm.
8. A 2-year rat inhalation study in rats showing female rats had a
statistically significant increase in total mammary tumors at the
highest concentration tested and a significant positive trend for total
mammary tumors. The Cancer Peer Review Committee concluded that this
was due to the less-than-usual incidence of total mammary tumors in the
control group, compared to historical controls, and concluded that
there was no convincing evidence of carcinogenicity in this study. The
systemic LOEL in this study is 0.2% (2,000 ppm) based on a significant
increase in the incidence of splenic congestion in males at 6 months,
decreased red cell count in males and females at the mid and high doses
at 6 months, increased absolute spleen weight in males at the high
concentration at 6 and 12 months, and congestion of the spleen in males
at the high dose at 6 months. The systemic NOEL is less than 0.2%
(2,000 ppm).
9. Two rat developmental effects studies by inhalation with a NOEL
for maternal toxicity of 2% DME and a NOEL for developmental toxicity
of 0.125% DME.
Based upon the above information and review of its use, EPA has
found that, when used in accordance with good agricultural practice,
this ingredient is useful and a tolerance is not necessary to protect
the public health. Therefore, EPA proposes that the exemption from the
requirement of a tolerance 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 Federal Food, Drug, and Cosmetic Act.
Interested persons are invited to submit written comments on the
proposed regulation. Comments must bear a notation indicating the
document control number, [OPP-300342]. All written comments filed in
response to this petition 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.
The Office of Management and Budget has exempted this rule from the
requirements of section 3 of Executive Order 12291.
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
Administrative practice and procedure, Agricultural commodities,
Pesticides and pests, Recording and recordkeeping requirements.
Dated: May 26, 1994.
Stephanie R. Irene,
Acting 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. Section 180.1001(e) is amended in the table therein by adding
and alphabetically inserting the inert ingredient, to read as follows:
Sec. 180.1001 Exemptions from the requirement of a tolerance.
* * * * *
(e) * * *
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Inert ingredients Limits Uses
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Dimethyl ether (CAS ....................... Propellant
Registry No. 115-10-6).
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[FR Doc. 94-15077 Filed 6-21-94; 8:45 am]
BILLING CODE 6560-50-F
