40 CFR Part 180

[OPP300308; FRL46497]

RIN No. 2070AC18

Polyethylene Glycol-Polyisobutenyl Anhydride-Tall Oil Fatty Acid Copolymer;
Tolerance Exemption

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

SUMMARY: This document proposes that an exemption from the requirement of a
tolerance be established for residues of polyethylene glycol-polyisobutenyl
anhydride-tall oil fatty acid copolymer when used as an inert ingredient
(surfactant, dispersing agent, suspending agent, or related adjuvant) in
pesticide formulations applied to growing crops or to raw agricultural
commodities after harvest. This proposed regulation was requested by ICI
Americas, Inc.

DATES: Comments, identified by the document control number [OPP-300308], must
be received on or before January 28, 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 (7505W), Office of Pesticide Programs,
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. Office
location and telephone number: Westfield Bldg. North, 6th Fl., 2800 Crystal
Drive, Arlington, VA 22202, (703)-308-8320.

SUPPLEMENTARY INFORMATION: ICI Americas, Inc., Wilmington DE 19897, has
submitted pesticide petition (PP) 3E4201 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(c) by
establishing an exemption from the requirement of a tolerance for residues of
polyethylene glycol-polyisobutenyl anhydride-tall oil fatty acid copolymer
when used as an inert ingredient (surfactant, dispersing agent, suspending
agent, or related adjuvant) 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 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
established data requirements which will be used to evaluate the risks posed
by the presence of an inert ingredient in a pesticide formulation. Exemptions
from some or all of the requirements may be granted if it can be determined
that the inert ingredient will present minimal or no risk. The Agency has
decided that the data normally required to support the proposed tolerance
exemption for polyethylene glycol-polyisobutenyl anhydride-tall oil fatty acid
copolymer 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. Polyethylene glycol-polyisobutenyl
anhydride-tall oil fatty acid copolymer 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 number-average molecular weight of the above-mentioned
copolymer is 5,000. Substances with molecular weights greater than 400 are
generally not readily absorbed through the intact skin, and substances with
molecular weights greater than 1,000 are generally not absorbed through the
intact gastrointestinal (GI) tract. Chemicals not absorbed through the skin or
GI tract are generally incapable of eliciting a toxic response.

2. The above-mentioned copolymer is not a cationic polymer nor is it
reasonably anticipated to become a cationic polymer in a natural aquatic
environment.

3. The above-mentioned copolymer does not contain less than 32.0 percent by
weight of the atomic element carbon.

4. The above-mentioned copolymer contains as an integral part of its
composition the atomic elements carbon, hydrogen, nitrogen, and oxygen.

5. The above-mentioned 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. The above-mentioned copolymer 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 copolymer is not manufactured from reactants
containing, other than as impurities, halogen atoms or cyano groups.

8. The above-mentioned copolymer does not contain reactive functional groups
that are intended or reasonably anticipated to undergo further reaction.

9. The above-mentioned copolymer 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-300308]. 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 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 10, 1993.

Stephen L. Johnson,

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:

 180.1001  Exemptions from the requirement of a tolerance.

                                  * * * * *

(c) * * *

c3,L2,tp0,s110,r65,r110

  [col head 1] Inert ingredients [col head 1] Limits [col head 1] Uses

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Polyethylene glycol-polyisobutenyl anhydride-tall oil fatty acid copolymer
(minimum number-average molecular weight 5,000)
	
	Surfactant, dispersing agent, suspending agent, or related adjuvant.

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[FR Doc. 9331476 Filed 122893; 8:45 am]

BILLING CODE 656050F


