[Federal Register Volume 60, Number 17 (Thursday, January 26, 1995)]
[Proposed Rules]
[Pages 5155-5157]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-1853]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300377; FRL-4928-5]
RIN 2070-AB78
Urea-Formaldehyde Copolymer; Tolerance Exemption
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: This document proposes to expand the current exemption from
the requirement of a tolerance for residues of urea-formaldehyde
copolymer (CAS Reg. No. 9011-05-6), when used as an inert ingredient in
pesticide formulations applied to growing crops only under 40 CFR
180.1001(d) to include uses as a solid diluent, filler and/or carrier
and to modify the minimum molecular weight from 30,000 to 20,000. Ciba-
Geigy Corp. requested this proposed regulation.
DATES: Written comments, identified by the document control number
[OPP-300377], must be received on or before February 27, 1995.
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, 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 [[Page 5156]] 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: By mail: Connie Welch, 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)-308-8470.
SUPPLEMENTARY INFORMATION: Ciba Geigy Corp., P.O. Box 18300,
Greensboro, NC 27419-8300, submitted pesticide petition (PP) 4E04423 to
EPA requesting that the Administrator, pursuant to section 408(e) of
the Federal Food Drug, and Cosmetic Act (FFDCA) (21 U.S.C. 346 a(e)),
propose to amend 40 CFR 180.1001(d) by revising the existing exemption
from the requirement of a tolerance for residues of urea-formaldehyde
copolymer (CAS Reg. No. 9011-056), when used as an inert ingredient
(encapsulating agent) in pesticide formulations applied to growing
crops only. The petitioner seeks to expand the use of urea-formaldehyde
copolymer to include solid diluent, filler, and carrier and to revise
the minimum number-average molecular weight from 30,000 to 20,000.
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 urea-formaldehyde
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. Urea-formaldehyde 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 urea-formaldehyde
copolymer is 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 tract. Chemicals not absorbed through skin
or GI tract generally are incapable of eliciting a toxic response.
2. Urea-formaldehyde copolymer is not a cationic polymer, nor is it
reasonably expected to become a cationic polymer in a natural aquatic
environment.
3. Urea-formaldehyde copolymer does not contain less than 32.0
percent by weight of the atomic element carbon.
4. Urea-formaldehyde copolymer contains as an integral part of its
coposition the atomic elements carbon, hydrogen, nitrogen, and oxygen.
5. Urea-formaldehyde 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. Urea-formaldehyde copolymer is not a biopolymer, a synthetic
equivalent of a biopolymer, or a dervative or modification of a
biopolymer that is substantially intact.
7. Urea-formaldehyde copolymer is not manufactured from reactants
containing, other than impurities, halogen atoms or cyano groups.
8. Urea-formaldehyde copolymer does not contain a reactive
functional group that is intended or reasonably expected to undergo
further reaction.
9. Urea-formaldehyde copolymer 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-300377]. 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, Reporting and
recordkeeping requirements.
[[Page 5157]] Dated: January 13, 1995.
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(d) is amended in the table therein by revising
the inert ingredient ``Urea-formaldehyde copolymer'', to read as
follows:
Sec. 180.1001 Exemptions from the requirement of a tolerance.
* * * * *
(d) * * *
------------------------------------------------------------------------
Inert ingredient Limits Uses
------------------------------------------------------------------------
* * * *
* * *
Urea-formaldehyde ................ Encapsulating agent,
copolymer (CAS Reg. No. solid diluent, filler,
9011-05-6); minimum carrier.
number average molecular
weight 20,000.
* * * *
* * *
------------------------------------------------------------------------
* * * * *
[FR Doc. 95-1853 Filed 1-25-95; 8:45 am]
BILLING CODE 6560-50-F
