[Federal Register Volume 59, Number 8 (Wednesday, January 12, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-765]


[[Page Unknown]]

[Federal Register: January 12, 1994]


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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180

[OPP-300319; FRL-4751-8]
RIN No. 2070-AC18

 

Alkyl (C12-C20) Methacrylate-Methacrylic Acid 
Copolymer; 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 alkyl (C12-C20) 
methacrylate-methacrylic acid copolymer when used as an inert 
ingredient (stabilizer; component of spray drift retardant) in 
pesticide formulations applied to growing crops only. This proposed 
regulation was requested by Allied Colloids, Inc.

DATES: Written comments, identified by the document control number 
[OPP-300319], must be received on or before February 11, 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, bring comments to: Rm. 1132, 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 may be disclosed publicly by EPA without prior notice. All 
written comments will be available for public inspection in Rm. 1132 at 
the Virginia address given above, from 8 a.m. to 4 p.m., Monday through 
Friday, excluding legal holidays.

FOR FURTHER INFORMATION CONTACT: By mail: Connie Welch, Registration 
Division (7505W), Environmental Protection Agency, 401 M St., SW., 
Washington, DC 20460. Office location and telephone number: 2800 
Crystal Drive, North Tower, 6th Floor, Arlington, VA 22202, (703)-308-
8320.

SUPPLEMENTARY INFORMATION: Allied Colloids, Inc., P.O. Box 820, 
Suffolk, VA 23434, has submitted pesticide petition (PP) 4E4277 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 residues of alkyl (C12 -C20) 
methacrylate-methacrylic acid copolymer when used as a stabilizer or 
component of spray drift retardant 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. Where it can be determined that the inert 
ingredient will present minimal or no risk, the Agency does not need 
some or all of the listed studies to rule on the proposed tolerance or 
exemption for an inert ingredient. The Agency has decided that any 
data, in addition to that described below, normally required to support 
the proposed tolerance exemption for alkyl (C12-C20) 
methacrylate-methacrylic acid copolymer will not need to be submitted. 
The rationale for this decision is described below:
    In the case of certain chemical substances that are defined as 
``polymers,'' the Agency has established a set of criteria which 
identify categories of polymers that present low risk. These criteria 
(described in 40 CFR 723.250) identify polymers that are relatively 
unreactive and stable compared to other chemical substances as well as 
polymers that typically are not readily absorbed. These properties 
generally limit a polymer's ability to cause adverse effects. In 
addition, these criteria exclude polymers about which little is known. 
The Agency believes that polymers meeting the criteria noted above will 
present minimal or no risk. Alkyl (C12-C20) methacrylate-
methacrylic acid copolymer conforms to the definition of polymers given 
in 40 CFR 723.250(b)(11) and meets the following criteria that are used 
to identify low-risk polymers:
    1. The minimum number average molecular weight of alkyl (C12 - 
C20) methacrylate-methacrylic acid copolymer is 11,900. Substances 
with molecular weights greater than 400 generally are not absorbed 
through the intact skin, and substances with molecular weights greater 
than 1,000 generally are not absorbed through the intact 
gastrointestinal (GI) tract. Chemicals not absorbed through skin or GI 
tract generally are incapable of eliciting a toxic response.
    2. Alkyl (C12 - C20) methacrylate-methacrylic acid 
copolymer is not a cationic polymer, nor is it reasonably anticipated 
to become a cationic polymer in a natural aquatic environment.
    3. Alkyl (C12 - C20) methacrylate-methacrylic acid 
copolymer does not contain less than 32.0 percent by weight of the 
atomic element carbon.
    4. Alkyl (C12 - C20) methacrylate-methacrylic acid 
copolymer contains as an integral part of its composition the atomic 
elements carbon, hydrogen, nitrogen, and oxygen.
    5. Alkyl (C12 - C20) methacrylate-methacrylic acid 
copolymer does not contain as an integral part of its composition, 
except as impurities, any elements other than those listed in 40 CFR 
723.250(d)(3)(ii).
    6. Alkyl (C12 - C20) methacrylate-methacrylic acid 
copolymer is not a biopolymer, a synthetic equivalent of a biopolymer, 
or a derivative or modification of a biopolymer that is substantially 
intact.
    7. Alkyl (C12 - C20) methacrylate-methacrylic acid 
copolymer is not manufactured from reactants containing, other than as 
impurities, halogen atoms or cyano groups.
    8. Alkyl (C12 - C20) methacrylate-methacrylic acid 
copolymer does not contain reactive functional groups that are intended 
or reasonably anticipated to undergo further reaction.
    9. Alkyl (C12 - C20) methacrylate-methacrylic acid 
copolymer is not designed or reasonably anticipated to substantially 
degrade, decompose, or depolymerize.
    Based on the information above 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, 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-300319]. 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 2 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 an 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: December 23, 1993.

Stephen L. Johnson,
Acting Director, Registration Division, Office of Prevention, 
Pesticides and Toxic Substances.

    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. In Sec. 180.1001, by amending paragraph (d) in the table therein 
by adding and alphabetically inserting the following 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          
------------------------------------------------------------------------
                                                                        
                                 * * * *                                
Alkyl (C12 - C20)          ..................  Stabilizer; component of 
 methacrylate-methacrylic                       spray drift retardant.  
 acid copolymer; minimum                                                
 molecular weight 11,900.                                               
                                                                        
                                 * * * *                                
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[FR Doc. 94-765 Filed 1-11-94; 8:45 am]
BILLING CODE 6560-50-F