cellulose acetate Proposed Tolerance Exemption 8/95
Date: Wed, 23 Aug 1995 11:19:17 -0400
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Subject: Cellulose Acetate; Tolerance Exemption X-Comment: U.S. EPA
FEDERAL REGISTER PESTICIDE documents Status: RO
[Federal Register: August 23, 1995 (Volume 60, Number 163)] [Proposed
>From the Federal Register Online via GPO Access [wais.access.gpo.gov]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
Cellulose Acetate; Tolerance Exemption
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
SUMMARY: This document proposes to establish an exemption from the
requirement of a tolerance for residues of cellulose acetate (CAS Reg.
No. 9004-35-7) when used as an inert ingredient (pesticide rate-release
regulating agent) in pesticide formulations applied to growing crops
only. Consep, Inc., requested this proposed regulation pursuant to the
Federal Food, Drug and Cosmetic Act (FFDCA).
DATES: Written comments, identified by the document control number [OPP-
300395], must be received on or before September 22, 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 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 4:30 p.m., Monday through Friday, excluding legal
Comments and data may also be submitted electronically by sending
electronic mail (e-mail) to: firstname.lastname@example.org. Electronic
comments must be submitted as an ASCII file avoiding the use of special
characters and any form of encryption. Comments and data will also be
accepted on disks in WordPerfect in 5.1 file format or ASCII file
format. All comments and data in electronic form must be identified by
the docket number [OPP-300395]. No Confidential Business Information
(CBI) should be submitted through e-mail. Electronic comments on this
proposed rule may be filed online at many Federal Depository Libraries.
Additional information on electronic submissions can be found below in
FOR FURTHER INFORMATION CONTACT: By mail: Mary Waller, 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)-308-8811; e-mail: email@example.com.
SUPPLEMENTARY INFORMATION: Consep, Inc., 213 Southwest Columbia St.,
Bend, OR 97702-1013, submitted pesticide petition (PP) 4E04401 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 part 180.1001(d) by exempting cellulose acetate
from the requirement of a tolerance. Cellulose acetate, when used as an
inert ingredient (pesticide rate-release regulating agent) in pesticide
formulations applied to growing crops only, under 40 CFR 180.1001(d),
meets the definition of a polymer under 40 CFR 723.250(b) and the
criteria listed in 40 CFR 723.250(e) that define a chemical substance
that poses no unreasonable risk under section 5 of the Toxic Substance
Control Act (TSCA).
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 cellulose acetate 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. Cellulose Acetate conforms to the definition
of a polymer given in 40 CFR 723.250(b) and meets the following criteria
that are used to identify low-risk polymers.
1. The minimum number average molecular weight of cellulose acetate is
28,000. 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. Cellulose acetate is not a cationic polymer, nor is it reasonably
expected to become a cationic polymer in a natural aquatic environment.
3. Cellulose acetate does not contain less than 32.0 percent by weight
of the atomic element carbon.
4. Cellulose acetate contains as an integral part of its composition the
atomic elements carbon, hydrogen, and oxygen.
5. Cellulose acetate 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)(2)(ii).
6. Cellulose acetate is not a biopolymer, a synthetic equivalent of a
biopolymer, or a derivative or modification of a biopolymer that is
7. Cellulose acetate is not manufactured from reactants containing,
other than as impurities, halogen atoms or cyano groups.
8. Cellulose acetate does not contain reactive functional groups that
are intended or reasonably expected to undergo further reaction.
9. Cellulose acetate 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-300395]. 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.
A record has been established for this rulemaking under docket number
[OPP-300395] (including comments and data submitted electronically as
described below). A public version of this record, including printed,
paper versions of electronic comments, which does not include any
information claimed as CBI, is available for inspection from 8 a.m. to
4:30 p.m., Monday through Friday, excluding legal holidays. The public
record is located in Room 1132 of the Public Response and Program
Resources Branch, Field Operations Division (7506C), Office of Pesticide
Programs, Environmental Protection Agency, Crystal Mall #2, 1921
Jefferson Davis Highway, Arlington, VA.
Electronic comments can be sent directly to EPA at: opp-
Electronic comments must be submitted as an ASCII file avoiding the use
of special characters and any form of encryption.
The official record for this rulemaking, as well as the public version,
as described above will be kept in paper form. Accordingly, EPA will
transfer all comments received electronically into printed, paper form
as they are received and will place the paper copies in the official
rulemaking record which will also include all comments submitted
directly in writing. The official rulemaking record is the paper record
maintained at the address in ``ADDRESSES'' at the beginning of this
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 Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Food additives, Pesticides and pests,
Processed foods, Reporting and recordkeeping requirements.
Dated: August 7, 1995.
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, it is proposed that 40 CFR part 180 be amended as follows:
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 adding and
alphabetically inserting the inert ingredient, to read as follows:
Sec. 180.1001 Exemptions from the requirement of a tolerance.
* * * * *
(d) * * *
Inert ingredient Limits Uses
Cellulose acetate (CAS.
Reg. No. 9004-35-7), minimum number-average Pesticide rate-release
molecular weight 28,000. regulating agent.
* * * * *
[FR Doc. 95-20889 Filed 8-22-95; 8:45 am] BILLING CODE 6560-50-F