[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) * * *
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Inert ingredients Limits Uses
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* * * * * * *
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
