[Federal Register Volume 59, Number 211 (Wednesday, November 2, 1994)]
[Proposed Rules]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-26809]


[[Page Unknown]]

[Federal Register: November 2, 1994]


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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180

[OPP-300364; FRL-4912-7]
RIN 2070-AC18

 

Acrylic Acid-Stearyl Methacrylate 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 acrylic acid-stearyl 
methacrylate copolymer (CAS Reg. No. 27756-15-6) when used as an inert 
ingredient (emulsifier, suspending agent, or rheology modifier) in 
pesticide formulations applied to growing crops, raw agricultural 
commodities after harvest, or animals. B. F. Goodrich Co. petitioned 
for this proposed regulation.

DATES: Comments, identified by the document control number [OPP-
300364], must be received on or before December 2, 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 to: Rm. 1132, Crystal Mall 
Bldg. #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 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 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, 6th floor, Arlington, VA 22202, (703)-308-8393.

SUPPLEMENTARY INFORMATION: The B. F. Goodrich Co., 3925 Embassy 
Parkway, Akron, OH 44313-1799, submitted pesticide petition (PP) 4E4298 
to EPA requesting that the Administrator, pursuant to section 408(e) of 
the Federal Food, Drug, and Cosmetic Act (FFDCA) (21 U.S.C. 346a(e)), 
propose to amend 40 CFR part 180 by establishing an exemption from the 
requirement of a tolerance for residues of acrylic acid-stearyl 
methacrylate copolymer (CAS Reg. No. 27756-15-6) when used as an inert 
ingredient (emulsifier, suspending agent, or rheology modifier) in 
pesticide formulations applied to growing crops, or to raw agricultural 
commodities after harvest, or 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; propellents 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.
    Subsequent to the publication of the proposal of B. F. Goodrich's 
request on February 25, 1994 (59 FR 9165), the Agency received a 
comment from the requestor (B. F. Goodrich) objecting to the proposed 
rule's requirement of a 1,250,000 minimum number-average molecular 
weight for the copolymer, stating that it was inconsistent with the 
October 28, 1992 final rule and would ``* * * place an unnecessary 
burden on both Industry and the Agency to list the same copolymer every 
time there is a desire to use a high molecular weight polymer not 
meeting a 1,250,000 requirement.'' The referenced final rule (57 FR 
48736) established an exemption from the requirement of a tolerance for 
residues of acrylic acid-stearyl methacrylate copolymer under 40 CFR 
180.1001(d), for use on growing crops, without containing a molecular 
weight limitation. The commentor stated that it was not their intention 
to limit the tolerance exemption for acrylic acid-stearyl methacrylate 
copolymer to a minimum number average molecular weight of 1,250,000 in 
the proposed rule and sought to eliminate the molecular weight 
limitation.
    The Agency agrees that an apparent inconsistency exists. The basis 
for the February 25, 1994, proposed rule was conformance to the 
criteria described in 40 CFR 723.250, which requires a reference to a 
minimum molecular weight. The previously established tolerance 
exemption under 40 CFR 180.1001(d) also relied on the fact that acrylic 
acid-stearyl methacrylate copolymer conformed to 40 CFR 723.250; 
however, a minimum number-average molecular weight was inadvertently 
omitted from that rule.
    Additional information was requested to be submitted by the 
petitioner to support the use of a new minimum-number average molecular 
weight for acrylic acid stearyl methacrylate copolymer which would 
still conform to 40 CFR 723.250. The requested information was 
provided, and the Agency is hereby proposing that the exemption from 
the requirement of a tolerance for acrylic acid-stearyl methacrylate 
copolymer specify the minimum number-average molecular weight as 2,500. 
EPA is deleting the entry for this chemical under 40 CFR 180.1001(d) 
because the requested expansion to section 180.1001(c) incorporates 
uses on growing crops as well as raw agricultural commodities.
    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 acrylic acid-stearyl 
methacrylate copolymer will 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. Acrylic acid-stearyl methacrylate copolymer 
conforms to the definition of a polymer 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 the acrylic acid-
stearyl methacrylate copolymer is 2,500. 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. Acrylic acid-stearyl methacrylate copolymer is not a cationic 
polymer, nor is it reasonably anticipated to become a cationic polymer 
in a natural aquatic environment.
    3. Acrylic acid-stearyl methacrylate copolymer does not contain 
less than 32.0 percent by weight of the atomic element carbon.
    4. Acrylic acid-stearyl methacrylate copolymer contains as an 
integral part of its composition the atomic elements carbon, hydrogen, 
nitrogen, and oxygen.
    5. Acrylic acid-stearyl methacrylate 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. Acrylic acid-stearyl methacrylate copolymer is not a biopolymer, 
a synthetic equivalent of a biopolymer, or a derivative or a 
modification of a biopolymer that is substantially intact.
    7. Acrylic acid-stearyl methacrylate copolymer is not manufactured 
from reactants containing, other than impurities, halogen atoms or 
cyano groups.
    8. Acrylic acid-stearyl methacrylate copolymer does not contain a 
reactive functional group that is intended, or reasonably anticipated, 
to undergo further reaction.
    9. Acrylic acid-stearyl methacrylate 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 (FIFRA) as amended, that contains any of the 
ingredients listed herein, may request within 30 days after the 
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 FFDCA.
    Interested persons are invited to submit written comments on the 
proposed regulation. Comments must bear a notation indicating the 
document control number [OPP-300364]. 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
    Environments Protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Recording and 
recordkeeping requirements.

    Dated: September 26, 1994.

Stephen L. Johnson,
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. In Sec. 180.1001, paragraphs (c) and (e) are amended in the 
tables therein by adding and alphabetically inserting the inert 
ingredient, and paragraph (d) is amended in the table therein by 
removing the entry for acrylic acid-stearyl methacrylate copolymer (CAS 
Reg. No. 27756-15-6), to read as follows:


Sec. 180.1001 Exemptions from the requirement of a tolerance.

* * * * *
    (c) *  *  *

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    Inert ingredients            Limits                   Uses          
------------------------------------------------------------------------
                                                                        
       *                  *                  *                  *       
                  *                  *                  *               
Acrylic acid-stearyl         ................  Emulsifier, suspending   
 methacrylate copolymer                         agent, or rheology      
 (CAS Reg. No. 27756-15-                        modifier.               
 6), minimum number                                                     
 average molecular weight                                               
 2,500.                                                                 
                                                                        
       *                  *                  *                  *       
                  *                  *                  *               
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* * * * *
    (e) *  *  *

------------------------------------------------------------------------
    Inert ingredients            Limits                   Uses          
------------------------------------------------------------------------
                                                                        
       *                  *                  *                  *       
                  *                  *                  *               
Acrylic acid-stearyl         ................  Emulsifier, suspending   
 methacrylate copolymer                         agent, or rheology      
 (CAS Reg. No. 27756-15-                        modifier.               
 6), minimum number                                                     
 average molecular weight                                               
 2,500.                                                                 
                                                                        
       *                  *                  *                  *       
                  *                  *                  *               
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[FR Doc. 94-26809 Filed 11-1-94; 8:45 am]
BILLING CODE 6560-50-F