[Federal Register Volume 59, Number 41 (Wednesday, March 2, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-4647]


[[Page Unknown]]

[Federal Register: March 2, 1994]


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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180

[OPP-300327; FRL-4762-1]
RIN 2070-AC18

 

Polyvinyl Alcohol; Tolerance Exemption

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: This document proposes that an exemption from the requirement 
of a tolerance be established for residues of polyvinyl alcohol (CAS 
Registry No. 9002-89-5) when used as an inert ingredient (surfactant) 
in pesticide formulations applied to food animals. This proposed 
regulation was requested by Farnum Companies, Inc.

DATES: Comments, identified by the document control number [OPP-
300327], must be received on or before April 1, 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 of 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 the EPA without 
prior notice. The public docket is available for public inspection in 
Rm. 1128 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, 
2800 Crystal Drive, 6th Floor, Arlington, VA 22202, (703)-308-8320.

SUPPLEMENTARY INFORMATION: Farnum Cos., Inc., 301 West Osborn, Phoenix, 
AZ 85013-3928, submitted pesticide petition (PP) 3E4176, requesting 
that the Administrator, pursuant to section 408(e) of the Federal Food, 
Drug, and Cosmetic Act, 21 U.S.C. 346a(e), amend 40 CFR 180.1001(e) by 
establishing an exemption from the requirement of a tolerance for 
residues of polyvinyl alcohol (CAS Registry No. 9002-89-5) when used as 
an inert ingredient (surfactant) in pesticide formulations applied to 
food animals.
    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 risk posed by the presence of an inert ingredient 
in a pesticide formulation. Where it can be determined that the inert 
ingredient will present minimal or no risk, the Agency generally does 
not need 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 any data, in addition to that 
described below, normally required to support polyvinyl alcohol will 
not need to be submitted. The rationale for this decision is described 
below.
    1. Polyvinyl alcohol (PVA) is very poorly absorbed by the oral and 
dermal route.
    2. Although PVA produces sarcomas, widespread cardiovascular 
lesions, severe glomerulonephritis and various organ enlargements when 
administered by subcutaneous injection, feeding studies indicate a low 
order of toxicity. When PVA was fed to rats (2 grams in 45 grams of 
feed for the first 2 weeks, followed by 4 grams in 45 grams of feed for 
the next 2 weeks), no toxic effects were observed and necropsy did not 
reveal any gross lesions of the internal organs.
    3. PVA is cleared as an indirect food additive for use in adhesives 
(21 CFR 175.105), resinous and polymeric coatings (21 CFR 175.300 and 
175.320), components of paper and paperboard in contact with food (21 
CFR 176.170 and 176.180), with cellophane in food packaging (21 CFR 
177.1200), in food-contact film (21 CFR 177.1670), in resin-bonded 
filters (21 CFR 177.2260), and in textiles and textile fibers (21 CFR 
177.2800).
    4. PVA is exempt from the requirement of a tolerance under 40 CFR 
180.1001(d) when used as a binder, water soluble bag container, or film 
tape for encapsulating seeds.
    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 he 
document control number, [OPP-300327]. 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 3 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 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, Pesticides and pests, Recording and 
recordkeeping requirements.

Dated: February 22, 1994.

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 is amended in paragraph (e) 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.

* * * * *
    (e) *  *  * 

------------------------------------------------------------------------
    Inert ingredients            Limits                   Uses          
------------------------------------------------------------------------
                                                                        
                              * * * * * * *                             
Polyvinyl alcohol (CAS     ..................  Surfactant               
 Registry No. 9002-89-5).                                               
                                                                        
                              * * * * * * *                             
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[FR Doc. 94-4647 Filed 3-1-94; 8:45 am]
BILLING CODE 6560-50-F