![[logo] US EPA](http://www.epa.gov/epafiles/images/logo_epaseal.gif){kind=logo}
Acrylic Acid-Stearyl Methacrylate Copolymer; Tolerance Exemption
Note: EPA no longer updates this information, but it may be useful as a reference or resource.
[Federal Register: November 2, 1994]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 acidstearyl
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) * * *
-----------------------------------------------------------------------
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.
* * * * * * *
-----------------------------------------------------------------------
* * * *
(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.
* * * * * * *
-----------------------------------------------------------------------
[FR Doc. 94-26809 Filed 11-1-94; 8:45 am]
BILLING CODE 6560-50-F