[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) *  *  *

------------------------------------------------------------------------
   Inert ingredients              Limits                   Uses         
------------------------------------------------------------------------
                                                                        
                                 *******                                
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