[Federal Register Volume 59, Number 38 (Friday, February 25, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-4378]


[[Page Unknown]]

[Federal Register: February 25, 1994]


-----------------------------------------------------------------------


ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180

[OPP-300324; FRL-4760-7]
RIN 2070-AC18

 

Cetyl Alcohol; Tolerance Exemption

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

-----------------------------------------------------------------------

SUMMARY: This document proposes that an exemption from the requirement 
of a tolerance be established for residues of cetyl alcohol (CAS Reg. 
No. 36653-82-4) when used as an inert ingredient (evaporation 
retardant) in pesticide formulations applied to growing crops or to raw 
agricultural commodities after harvest. This proposed regulation was 
requested by Roussel Uclaf Corp.
DATES: Comments, identified by the document control number [OPP-
300324], must be received on or before March 28, 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, CM #2, 
1921 Jefferson Davis Hwy., Arlington, VA 22202.
    Information submitted as a comment concerning this document may be 
claimed confidential by marking any part or 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: Rosalind L. Gross, 
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: 6th Floor, 
CS #1, 2800 Crystal Drive, North Tower, Arlington, VA 22202, (703)-308-
8354.

SUPPLEMENTARY INFORMATION: Roussel Uclaf Corp., 95 Chestnut Ridge Rd., 
P.O. Box 30, Montvale, NJ 07645, submitted pesticide petition (PP) 
3E4207 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(c) to exempt from the requirement of a 
tolerance residues of cetyl alcohol (CAS Reg. No. 36653-82-4) when used 
as an inert ingredient (evaporation retardant) in pesticide 
formulations applied to growing crops or to raw agricultural 
commodities after harvest.
    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. Where it can be determined that the inert 
ingredient will present minimal or no risk, the Agency may waive some 
or all of the listed studies. The Agency has decided that no additional 
data will need to be submitted to support the proposed tolerance 
exemption for cetyl alcohol. The rationale for this decision is 
described below.
    1. Cetyl alcohol is approved for use as a direct food additive 
under 21 CFR 172.515 (synthetic flavoring substances and adjuvants).
    2. Cetyl alcohol is contained in a drug recently approved by the 
Food and Drug Administration for use as a direct spray into the lungs 
of newborns in order to prevent and/or treat idopathic respiratory 
distress syndrome.
    3. Cetyl alcohol is approved for use as an indirect food additive 
under 21 CFR 175.105, 21 CFR 175.300 (indirect food additives: 
adhesives and components of coatings), 21 CFR 176.200, 21 CFR 176.210 
(indirect food additives: paper and paperboard components), 21 CFR 
177.1200, 21 CFR 177.1210, 21 CFR 177.1350, 21 CFR 177.1400, and 21 CFR 
177.2800 (indirect food additives: polymers), and 21 CFR 178.3910 
(indirect food additives: adjuvants, production aids, and sanitizers).
    The Agency has reviewed the supporting literature for the 
aforementioned FDA clearances on cetyl alcohol. This review supports 
the use of cetyl alcohol as an evaporation retardant in pesticide 
formulations applied to growing crops or to raw agricultural 
commodities after harvest, at concentrations of not more than 5.0 
percent of the pesticide formulation. Based upon the above information 
and review of its use, EPA has found that, when used in accordance with 
good agricultural practices, 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-300324]. 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 Executive Order 12866.
    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: February 14, 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(c) is amended in the table therein by adding 
and alphabetically inserting the entry for cetyl alcohol, to read as 
follows:


Sec. 180.1001   Exemptions from the requirement of a tolerance.

* * * * *
    (c) *  *  *

------------------------------------------------------------------------
    Inert ingredients            Limits                  Uses           
------------------------------------------------------------------------
                                                                        
                              * * * * * * *                             
Cetyl alcohol (CAS Reg.    Not more than 5.0%  Evaporation retardant    
 No. 36653-82-4).           of pesticide                                
                            formulation.                                
                                                                        
                              * * * * * * *                             
------------------------------------------------------------------------

* * * * *

[FR Doc. 94-4378 Filed 2-24-94; 8:45 am]
BILLING CODE 6560-50-F