[Federal Register Volume 59, Number 109 (Wednesday, June 8, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-13674]
[[Page Unknown]]
[Federal Register: June 8, 1994]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300344; FRL-4868-1]
RIN 2070-AC18
Vinyl Pyrrolidone-Dimethylaminoethylmethacrylate 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 vinyl pyrrolidone-
dimethylaminoethylmethacrylate copolymer (CAS Reg. No. 30581-59-0) when
used as an inert ingredient (leaching inhibitor, binder for water
dispersable aggregates, sticker and suspension stabilizer) in pesticide
formulations applied to growing crops or to raw agricultural
commodities after harvest, and to animals. This proposed regulation was
requested by International Specialty Products.
DATES: Comments, identified by the document control number [OPP-
300344], must be received on or before July 8, 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 comments 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: International Specialty Products, 1361 Alps
Rd., Wayne, NJ 07470, submitted pesticide petition (PP) 4E04319 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 vinyl pyrrolidone-
dimethylaminoethylmethacrylate copolymer (CAS Reg. No. 30581-590) when
used as an inert ingredient (leaching inhibitor, binder for water
dispersable aggregates, sticker and suspension stabilizer) in pesticide
formulations applied to growing crops or to raw agricultural
commodities after harvest, and 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; 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 that 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 vinyl pyrrolidone-
dimethylaminoethylmethacrylate 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. Vinyl pyrrolidone-
dimethylaminoethylmethacrylate 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 vinyl
pyrrolidone-dimethylaminoethylmethacrylate copolymer is greater than
20,000. 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 (GI) tract. Chemicals not absorbed through skin
or GI tract generally are incapable of eliciting a toxic response.
2. Vinyl pyrrolidone-dimethylaminoethylmethacrylate copolymer is
not a cationic polymer, nor is it reasonably anticipated to become a
cationic polymer in a natural aquatic environment.
3. Vinyl pyrrolidone-dimethylaminoethylmethacrylate copolymer does
not contain less than 32.0 percent by weight of the atomic element
carbon.
4. Vinyl pyrrolidone-dimethylaminoethylmethacrylate copolymer
contains as an integral part of its composition the atomic elements
carbon, hydrogen, nitrogen, and oxygen.
5. Vinyl pyrrolidone-dimethylaminoethylmethacrylate 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. Vinyl pyrrolidone-dimethylaminoethylmethacrylate 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. Vinyl pyrrolidone-dimethylaminoethylmethacrylate copolymer is
not manufactured from reactants containing, other than impurities,
halogen atoms or cyano groups.
8. Vinyl pyrrolidone-dimethylaminoethylmethacrylate copolymer does
not contain a reactive functional group that is intended or reasonably
anticipated to undergo further reaction.
9. Vinyl pyrrolidone-dimethylaminoethylmethacrylate copolymer is
not designed or 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-300344]. 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, Recording and
recordkeeping requirements.
Dated: May 26, 1994.
Stephanie R. Irene,
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(c) is amended 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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* * * * * * *
Vinyl pyrrolidone- .................. Leaching inhibitor,
dimethylaminoethylmethac binder for water
rylate copolymer (CAS dispersable aggregates,
Reg. No. 30581-590), sticker and suspension
minimum number average stabilizer.
molecular weight 20,000..
* * * * * * *
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[FR Doc. 94-13674 Filed 6-7-94; 8:45 am]
BILLING CODE 6560-50-F
