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cetyl alcohol Proposed Tolerance Exemption 2/94

40 CFR Part 180

[OPP-300324; FRL-4760-7]

RIN 2070-AC18

Cetyl Alcohol; Tolerance Exemption 

AGENCY: Environmental Protection Agency (EPA). 

ACTION: Proposed rule.
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40 CFR Part 180

[OPP-300324; FRL-4760-7]

RIN 2070-AC18

Cetyl Alcohol; Tolerance Exemption 

AGENCY: Environmental Protection Agency (EPA). 

ACTION: Proposed rule.
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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: 

 180.1001   Exemptions from the requirement of a tolerance.
*     *     *     *     *     
   (c) * * *


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

[FR Doc. 94-4378 Filed 2-24-94; 8:45 am]