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alpha-alkyl(C21-C71)-omega-hydroxypoly (oxyethylene) Tolerance Exemption 9/95

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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[PP 5E4540/P633; FRL-4977-8]
RIN 2070-AC18
alpha-Alkyl (C21-C71)-omega-Hydroxypoly(Oxyethylene); Tolerance Exemption
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: This document proposes that residues of alpha-alkyl 
(C21-C71)-omega-hydroxypoly(oxyethylene) be exempted 
from the requirement of a tolerance when used at levels not to exceed 
10% as a wetting agent or granule coating in pesticide formulations. 
Petrolite Corp. requested this regulation under the Federal Food, Drug 
and Cosmetic Act (FFDCA).

DATES: Comments, identified by the document control number [PP 5E4540/
P633], must be received on or before October 30, 1995.

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. 1132, 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. 1132 at the address given above, from 8 a.m. to 4:30 p.m., Monday 
through Friday, excluding legal holidays.
    Comments and data may also be submitted electronically by sending 
electronic mail (e-mail) to: opp-docket@epamail.epa.gov. Electronic 
comments must be submitted as an ASCII file avoiding the use of special 
characters and any form of encryption. Comments and data will also be 
accepted on disks in WordPerfect in 5.1 file format or ASCII file 
format. All comments and data in electronic form must be identified by 
the docket number [PP 5E4540/P633]. No Confidential Business 
Information (CBI) should be submitted through e-mail. Electronic 
comments on this proposed rule may be filed online at many Federal 
Depository Libraries. Additional information on electronic submissions 
can be found below in this document.

FOR FURTHER INFORMATION CONTACT: By mail: Amelia M. Acierto, 
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)-308-8375; e-mail:
                     acierto.amelia@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: Petrolite Corp., Polymers Division, 6910 
East 14th St., Tulsa, OK 74112, submitted pesticide petition (PP) 
5E4540 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(d) by establishing an exemption from 
the requirement of a tolerance for alpha-alkyl (C21-C71)-omega-hydroxypoly 
(oxyethylene) when used at levels not to exceed 10% as a wetting agent or 
granule coating in pesticide formulations applied to growing crops only.
    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 
these 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 alpha-alkyl 
(C21-C71)-omega-hydroxypoly(oxyethylene) will need to be 
submitted. The rationale for this decision is described below:
    1. The rat acute oral toxicity studies with acute oral LD50 
values varying from 410 mg/kg to 25,000 mg/kg.
    2. The acute dermal toxicity studies with acute dermal LD50 
values from 930 mg/kg to 11,800 mg/kg in rabbits and > 2,000 mg/kg in 
rats.
    3. Mutagenicity studies including Salmonella typhimurium plate 
(Ames) tests with and without activation, structural chromosomal 
aberration test and other genotoxic effects tests were negative.
    4. The 90-day feeding toxicity study in rats with a NOEL 15 mg/kg/
day.
    5. The 90-day dermal toxicity study with a NOEL of 20 mg/kg/day in 
rabbits and greater than 125 mg/kg/day in rats.
    6. The developmental toxicity study in rabbits with a systemic 
maternal NOEL of 50 mg/kg/day and a developmental NOEL of > 200 mg/kg/
day indicating no evidence of developmental effects.
    7. The rat reproductive toxicity study with the systemic and 
developmental NOEL of 50 mg/kg/day and reproductive NOEL of > 250 mg/
kg/day indicating no evidence of reproductive effects.
    8. The rat chronic and carcinogenicity study with systemic NOEL of 
50 mg/kg/day showing no evidence of carcinogenicity effects.
    Based upon the above evaluation of the toxicological data which 
shows no evidence of carcinogenicity, mutagenicity (Ames Test), acute 
and subchronic dermal, developmental or reproductive toxicity of 
alpha-alkyl (C21-C71)-omega-hydroxypoly 
(oxyethylene) and the expected dietary exposure, the Agency concludes 
that this chemical poses no significant risks under the proposed 
conditions of use and that no further data are required. In addition, 
these chemicals are similar to other ethoxylated alcohols [C12-15-
polyethoxylated alcohols (CAS # 68131-40-8), C12-20-ethoxylated 
alcohols (CAS # 68526-94-3) and C12-18-ethoxylated-propoxylated 
alcohol (CAS # 69227-21-0)], which have already been exempted from the 
requirement of a tolerance under 40 CFR 180.1001(c) or (d) based on 
data indicating no adverse toxicological effects. Furthermore, these 
chemicals are among those that the Agency has sufficient information to 
conclude that their current use patterns in pesticide products will not 
adversely affect public health and the environment and which have 
subsequently been reclassified from List 3 (inert ingredients of 
unknown toxicity) to List 4b (inert ingredients of minimal concern) (60 
FR 35396, July 7, 1995). The alpha-alkyl (C21-C71)-
omega -hydroxypoly(oxyethylene) merely have a longer carbon chain, 
and the expected breakdown products are similar to the shorter extant 
ethoxylated alcohols. There is no reason to believe that there would be 
any toxicological concern for the longer carbon chain-length alcohols 
since these would most likely result in decreased absorption and 
toxicity. Furthermore, similar surfactants, i.e., ethoxylated fatty 
acids and their salts and esters, ethoxylated polyglycols, ethoxylated 
amines, and others, are presently exempted from tolerances under 40 CFR 
180.1001.
    Based upon the information above, the toxicological data and 
physico-chemical properties of alpha-alkyl (C21-C71)-
alpha-hydroxypoly(oxyethylene), and review of its use, the Agency 
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, [PP 5E4540/P633]. 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 
4:30 p.m. Monday through Friday, except legal holidays.
     A record has been established for this rulemaking under docket 
number [PP 5E4540/P633] (including comments and data submitted 
electronically as described below). A public version of this record, 
including printed, paper versions of electronic comments, which does 
not include any information claimed as CBI, is available for inspection 
from 8 a.m. to 4:30 p.m., Monday through Friday, excluding legal 
holidays. The public record is located in Room 1132 of the Public 
Response and Program Resources Branch, Field Operations Division 
(7506C), Office of Pesticide Programs, Environmental Protection Agency, 
Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA.
    Electronic comments can be sent directly to EPA at:
                      opp-Docket@epamail.epa.gov


    Electronic comments must be submitted as an ASCII file avoiding the 
use of special characters and any form of encryption.
    The official record for this rulemaking, as well as the public 
version, as described above will be kept in paper form. Accordingly, 
EPA will transfer all comments received electronically into printed, 
paper form as they are received and will place the paper copies in the 
official rulemaking record which will also include all comments 
submitted directly in writing. The official rulemaking record is the 
paper record maintained at the address in "ADDRESSES" at the 
beginning of this document.
    The Office of Management and Budget has exempted this rule from the 
requirements of section 3 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

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: September 19, 1995.

Peter Caulkins,
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(d) 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.

* * * * *
    (d) * * *


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    Inert ingredients            Limits                   Uses          
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         *        *        *        *        *        *        *        
alpha-Alkyl (C21-C71)-        Not to exceed 10%.       Wetting agent or 
 omega-hydroxypoly            in which                  granule coating 
 (oxyethylene)                the poly(oxyethylene)                     
                              content is 2 to 91 moles                  
                              and molecular weight                      
                              range from 390 to 5,000.                  
                                                                        
         *        *        *        *        *        *        *        
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