[Federal Register Volume 59, Number 168 (Wednesday, August 31, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-21103]


[[Page Unknown]]

[Federal Register: August 31, 1994]


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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180

[OPP-300356; FRL-4906-1]
RIN 2070-AC18

 

Poly(vinylpyrrolidone); Tolerance Exemption

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: This document proposes to establish an exemption from the 
requirement of a tolerance for residues of poly(vinylpyrrolidone) (CAS 
Reg. No. 9003-39-8) when used as an inert ingredient (surfactant, 
related adjuvants of surfactant) in pesticide formulations applied to 
growing crops or to raw agricultural commodities after harvest. 
International Specialty Products requested this proposed rule.

DATES: Written comments, identified by the document control number 
[OPP-300356], must be received on or before September 30, 1994.

ADDRESSES: By mail, submit written comments to: Public Response 
Section, Field Operations Division (7506C), Office of Pesticide 
Programs, Environmental Protection Agency, 401 M St., SW., Washington, 
DC 20460. In person, bring 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 may be disclosed publicly by EPA without prior notice. All 
written comments will be available for public inspection in Rm. 1132 at 
the Virginia 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), 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, has submitted pesticide petition (PP) 4E4308 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 revising the currently listed 
exemption from the requirement of a tolerance for residues of 
poly(vinylpyrrolidone) (CAS Reg. No. 9003-39-8) when used as an inert 
ingredient (surfactant, related adjuvants of surfactant) in pesticide 
formulations applied to growing crops or to raw agricultural 
commodities after harvest to include poly(vinyl pyrrolidone) polymers 
of molecular weights greater than 4,000. The current molecular weight 
limit is 40,000 or over.
    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 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 poly(vinylpyrrolidone) 
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. Poly(vinylpyrrolidone) 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 poly(vinyl-
pyrrolidone) is 4,000. 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. Poly(vinylpyrrolidone) is not a cationic polymer, nor is it 
reasonably expected to become a cationic polymer in a natural aquatic 
environment.
    3. Poly(vinylpyrrolidone) does not contain less than 32.0 percent 
by weight of the atomic element carbon.
    4. Poly(vinylpyrrolidone) contains as an integral part of its 
composition the atomic elements carbon, hydrogen, nitrogen, and oxygen.
    5. Poly(vinylpyrrolidone) 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. Poly(vinylpyrrolidone) is not a biopolymer, a synthetic 
equivalent of a biopolymer, or a derivative or modification of a 
biopolymer that is substantially intact.
    7. Poly(vinylpyrrolidone) is not manufactured from reactants 
containing, other than as impurities, halogen atoms or cyano groups.
    8. Poly(vinylpyrrolidone) does not contain a reactive functional 
group that is intended or reasonably expected to undergo futher 
reaction.
    9. Poly(vinylpyrrolidone) 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-300357]. 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, Food additives, Pesticides and pests, 
Processed foods, Reporting and recordkeeping requirements.

Dated: August 19, 1994.

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(c) 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.

*        *        *        *        *
    (c) *  *  *

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    Inert ingredients            Limits                   Uses          
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                              * * * * * * *                             
Poly(vinylpyrrolidone)     ..................  Surfactant, related      
 (CAS Reg. No. 9003-39-                         adjuvants of surfactant.
 8), minimum number-                                                    
 average molecular weight                                               
 4,000..                                                                
                                                                        
                              * * * * * * *                             
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* * * * *

[FR Doc. 94-21103 Filed 8-30-94; 8:45 am]
BILLING CODE 6560-50-F