[Federal Register Volume 59, Number 229 (Wednesday, November 30, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-28977]
[[Page Unknown]]
[Federal Register: November 30, 1994]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300372; FRL-4921-5]
RIN 2070-AC18
Acrylamide-Potassium Acrylate-Acrylic Acid Copolymer,
Crosslinked; Tolerance Exemption
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: This document proposes to establish an exemption from the
requirement of a tolerance for residues of acrylamide-potassium
acrylate-acrylic acid copolymer, cross-linked (CAS Reg. No. 31212-13-
2), when used as an inert ingredient (carrier) in pesticide
formulations applied to growing crops or to raw agricultural
commodities after harvest. Kelly Products, Inc., requested this
proposed rule.
DATES: Written comments, identified by the document control number
[OPP-300372], must be received on or before December 30, 1994.
ADDRESSES: By mail, submit written comments to Public Response Section,
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 will be included in the public docket by EPA without prior
notice. All written comments will be 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: Tina Levine, Registration Support
Branch, 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)-308-8393.
SUPPLEMENTARY INFORMATION: Kelly Products, Inc., P.O. Box 1508, 4132
Highway 278, NW., Covington, GA 30209, submitted pesticide petition
(PP) 4E4348 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 180.1001(c) by establishing an
exemption from the requirement of a tolerance for residues of
acrylamide-potassium acrylate-acrylic acid copolymer, cross-linked (CAS
Reg. No. 31212-13-2), when used as an inert ingredient (carrier) 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 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
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 acrylamide-potassium
acrylate-acrylic acid copolymer, crosslinked, 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. Acrylamide-potassium acrylate-acrylic acid
copolymer, cross-linked, conforms to the definition of a polymer 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 acrylamide-
potassium acrylate-acrylic acid copolymer, crosslinked, is estimated to
be approximately 1,000,000. 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 tract. Chemicals not
absorbed through skin or GI tract generally are incapable of eliciting
a toxic response.
2. Acrylamide-potassium acrylate-acrylic acid copolymer, cross-
linked, is not a cationic polymer, nor is it reasonably expected to
become a cationic polymer in a natural aquatic environment.
3. Acrylamide-potassium acrylate-acrylic acid copolymer, cross-
linked, does not contain less than 32.0 percent by weight of the atomic
element carbon.
4. Acrylamide-potassium acrylate-acrylic acid copolymer, cross-
linked, contains as an integral part of its coposition the atomic
elements carbon, hydrogen, nitrogen, and oxygen.
5. Acrylamide-potassium acrylate-acrylic acid copolymer, cross-
linked, 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. Acrylamide-potassium acrylate-acrylic acid copolymer, cross-
linked, is not a biopolymer, a synthetic equivalent of a biopolymer, or
a dervative or modification of a biopolymer that is substantially
intact.
7. Acrylamide-potassium acrylate-acrylic acid copolymer, cross-
linked, is not manufactured from reactants containing, other than
impurities, halogen atoms or cyano groups.
8. Acrylamide-potassium acrylate-acrylic acid copolymer, cross-
linked, does not contain a reactive functional group that is intended
or reasonably expected to undergo further reaction.
9. Acrylamide-potassium acrylate-acrylic acid copolymer, cross-
linked, is neither designed nor reasonably expected 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-300372]. 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 requirement 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 Subject in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Processed foods,
Reporting and recordkeeping requirements.
Dated: November 15, 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. Section 180.1001(c) 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.
* * * * *
(c) * * *
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Inert ingredients Limits Uses
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* * * * * * *
Acrylamide potassium .................. Carrier.
acrylate-acrylic acid
copolymer, crosslinked
(CAS Reg. No. 31212-13-
2), minimum number
average molecular weight
1,000,000.
* * * * * * *
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[FR Doc. 94-28977 Filed 11-29-94; 8:45 am]
BILLING CODE 6560-50-F
