[Federal Register Volume 61, Number 133 (Wednesday, July 10, 1996)]
[Proposed Rules]
[Pages 36331-36333]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-17577]


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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180

[PP 6E4644/P668; FRL-5380-5]

RIN 2070-AC18


Polyvinylpyrrolidone Butylated Polymer; 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 polyvinylpyrrolidone 
butylated polymer when used as an inert ingredient (surfactants, 
related adjuvant of surfactants and binder) in pesticide formulations 
applied to growing crops, raw agricultural commodities after harvest, 
and applied to animals. This proposed regulation was requested by 
International Specialty Products.

DATES: Written comments, identified by the document control number [PP 
6E4644/P668], must be received on or before August 9, 1996.

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 holidays.
    Comments and data may also be submitted electronically by sending 
electronic mail (e-mail) to: [email protected]. 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 5.1 file format or ASCII file format. 
All comments and data in electronic form must be identified by the 
docket number [PP 6E4644/P668]. 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 in the 
SUPPLEMENTARY INFORMATION section of this document.

FOR FURTHER INFORMATION CONTACT: By mail: Bipin Gandhi, 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, 703-308-8380, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: International Specialty Products, 1361 Alps 
Road, Wayne, NJ 07470, submitted pesticide petition (PP) 6E4644 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(c) and (e) by exempting 
polyvinylpyrrolidone butylated polymer (CAS No. 26160-96-3) when used 
as an inert ingredient (surfactants, related adjuvant of surfactants 
and binder) in pesticide formulations applied to growing crops or to 
raw agricultural commodities after harvest, under 40 CFR 180.1001(c) 
and applied to animals under 40 CFR 180.1001(e) and deleting the 
current exemption from the requirement of a tolerance under 40 CFR 
180.1001(d) for application to growing crops only. 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

[[Page 36332]]

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 polyvinylpyrrolidone butylated 
polymer 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. Polyvinylpyrrolidone, butylated polymer 
conforms to the definition of polymer given in 40 CFR 723(b) and meets 
the following criteria that are used to identify low risk polymers:
    1. Polyvinylpyrrolidone, butylated polymer is not a cationic 
polymer, nor is it reasonably anticipated to become a cationic polymer 
in a natural aquatic environment.
    2. Polyvinylpyrrolidone, butylated polymer contains as an integral 
part of its composition the atomic elements carbon, hydrogen, oxygen, 
and nitrogen.
    3. Polyvinylpyrrolidone, butylated 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)(2)(ii).
    4. Polyvinylpyrrolidone, butylated polymer is not designed, nor it 
is reasonably anticipated to substantially degrade, decompose or 
depolymerize.
    5. Polyvinylpyrrolidone, butylated polymer is not manufactured or 
imported from monomers and /or other reactants that are not already 
included on the TSCA Chemical Substance Inventory or manufactured under 
an applicable TSCA section 5 exemption.
    6. The minimum number-average molecular weight of 
polyvinylpyrrolidone, butylated polymer is listed as 9,569 daltons. 
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 (GI) tract. Chemicals not absorbed through the skin or 
GI tract generally are incapable of eliciting a toxic response.
    7. Polyvinylpyrrolidone, butylated polymer has a number average 
molecular weight of 9,569 and contains less than 10 percent oligomeric 
material below molecular weight 500 and less than 25 percent oligomeric 
material below 1,000 molecular weight.
    8. Polyvinylpyrrolidone, butylated polymer does not contain 
reactive functional groups that are intended or reasonably anticipated 
to undergo further reaction. Based on 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 tolerance is not 
necessary to protect the public health and to reclassify this product 
from 40 CFR 180.1001(d) to 40 CFR 180.1001(c) and (e). Therefore, EPA 
proposes that the exemptions from the requirement of a tolerance be 
established for this polymer 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, [PP 6E4644/P668].
    A record has been established for this rulemaking under docket 
number [PP 6E4644/P668] (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-D[email protected]
    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 be placed in the paper copies 
of the official rulemaking record which also will include all comments 
submitted directly in writing. The official rulemaking record is the 
paper record maintained at the address in the ``ADDRESSES'' at the 
beginning of this document.
    The Office of Management and Budget has exempted this rule from the 
requirements of section 2 of Executive Order 12866.
    This action does not impose any enforceable duty, or contain any 
``unfunded mandates'' as described in Title II of the Unfunded Mandates 
Reform Act of 1995 (Pub. L. 104-4), or require prior consultation as 
specified by Executive Order 12875 (58 FR 58093, October 28, 1993), 
entitled Enhancing the Intergovernmental Partnership, or special 
consideration as required by Executive Order 12898 (59 FR 7629, 
February 16, 1994).
    Under 5 U.S.C. 801(a)(1)(A) of the Administrative Procedure Act 
(APA) as amended by the Small Business Regulatory Enforcement Fairness 
Act of 1996 (Title II of Pub. L. 104-121, 110 Stat. 847), EPA submitted 
a report containing this rule and other required information to the 
U.S. Senate, the U.S. House of Representatives and the Comptroller 
General of the General Accounting Office prior to publication of the 
rule in today's Federal Register. This rule is (is not) a ``major 
rule'' asdefined by 5 U.S.C. 804(2) of the APA as amended.
    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 explaining the basis for this 
determination 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, Food additives, Pesticides and pests, 
Processed foods, Reporting and recordkeeping requirements.


[[Page 36333]]


    Dated: July 2, 1996.

Peter Caulkins,
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. In Sec. 180.1001 the table in paragraph (c) and (e) is amended 
by adding alphabetically the inert ingredient, to read as set forth 
below, and the table in paragraph (d) is amended by removing the entry 
for ``Polyvinylpyrrolidone butylated,'' follows:


Sec. 180.1001 Exemptions from the requirement of a tolerance.

*      *      *      *      *
    (c) *       *       *

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         Inert Ingredient              Limits               Uses        
------------------------------------------------------------------------
                                                                        
         *        *        *        *        *        *        *        
Polyvinylpyrrolidone butylated                      Surfactants, related
 polymer, minimum number-average                    adjuvant of         
 molecular weight (in amu) 9,500.                   surfactants and     
                                                    binder.             
                                                                        
         *        *        *        *        *        *        *        
------------------------------------------------------------------------

    (e) *       *       *

------------------------------------------------------------------------
         Inert Ingredient              Limits               Uses        
------------------------------------------------------------------------
                                                                        
         *        *        *        *        *        *        *        
Polyvinylpyrrolidone butylated                     Surfactants, related 
 polymer, minimum number-average                    adjuvant of         
 molecular weight (in amu) 9,500.                   surfactants and     
                                                    binder.             
                                                                        
         *        *        *        *        *        *        *        
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[FR Doc. 96-17577 Filed 7-9-96; 8:45 am]
BILLING CODE 6560-50-F