[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: 94-764]
[[Page Unknown]]
[Federal Register: January 12, 1994]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300317; FRL-4749-1]
RIN No. 2070-AC18
Cross-linked Polyurea-Type Encapsulating Polymer 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 cross-linked polyurea-
type encapsulating polymer when used as an inert ingredient
(encapsulating agent) in pesticide formulations for application to
animals. This proposed regulation was requested by Zeneca Ag Products.
DATES: Comments, identified by the document control number [OPP-
300317], 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, 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: Connie Welch, Registration
Support Branch, Registration Division (7505C), 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)-308-8320.
SUPPLEMENTARY INFORMATION: Zeneca Ag Products, P.O. Box 751,
Wilmington, DE 19897, has submitted pesticide petition (PP) 3E4269 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(e) by establishing an exemption from the
requirement of a tolerance for residues of cross-linked polyurea-type
encapsulating polymer when used as an inert ingredient (encapsulating
agent) in pesticide formulations for application 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 support of the current exemption and also the
data submitted in this petition 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 generally 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 cross-linked polyurea-
type encapsulating polymer will not need to be submitted. The rationale
for this decision is described below.
In the case of certain chemical substances which 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. Cross-linked polyurea-type encapsulating
polymer conforms to the definition of a polymer given in 40 CFR
723.250(b)(11) and meets the following criteria which are used to
identify low risk polymers:
1. The minimum average molecular weight of the above-mentioned
polymer is 5 X 1013. Substances with molecular weights greater
than 400 generally are not readily 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 the skin or GI tract generally are incapable of
eliciting a toxic response.
2. The above-mentioned polymer is not a cationic polymer, nor is it
reasonably anticipated to become a cationic polymer in a natural
aquatic environment.
3. The above-mentioned polymer does not contain less than 32.0
percent by weight of the atomic element carbon.
4. The above-mentioned polymer contains as an integral part of its
composition the atomic elements carbon, hydrogen, nitrogen, and oxygen.
5. The above-mentioned polymer 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. The above-mentioned polymer is not a biopolymer, a synthetic
equivalent of a biopolymer, or a derivative or modification of a
biopolymer that is substantially intact.
7. The above-mentioned polymer is not manufactured from reactants
containing, other than as impurities, halogen atoms or cyano groups.
8. The above-mentioned polymer does not contain reactive functional
groups that are intended or reasonably anticipated to undergo further
reaction.
9. The above-mentioned polymer is not designed or reasonably
anticipated to substantially degrade, decompose, or depolymerize.
Based upon the above information 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, 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-300137]. 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 3 of Executive Order 12291. 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 a
significant economic effect 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: 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. Section 180.1001(e) is amended by adding and alphabetically
inserting the inert ingredient, to read as follows:
Sec. 180.1001 Exemptions from the requirement of a tolerance.
* * * * *
(e) * * *
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Inert ingredients Limits Uses
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Cross-linked polyurea- .................. Encapsulating agent
type encapsulating
polymer.
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[FR Doc. 94-764 Filed 1-11-94; 8:45 am]
BILLING CODE 6560-50-F
