[Federal Register Volume 61, Number 124 (Wednesday, June 26, 1996)]
[Proposed Rules]
[Pages 33057-33059]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-16334]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[PP-5E4472/P667; FRL-5378-2]
RIN 2070-AC18
Copper 8-quinolinolate; Proposed Tolerance Exemption
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: This document proposes that residues of copper 8-quinolinolate
(CAS Reg. No. 10380-28-6) be exempted from the requirement of a
tolerance when used as an inert ingredient (preservative) in
pesticidally treated paper products used on growing crops. This
proposed regulation was requested by American Agricultural Services
Inc., pursuant to the Federal Food, Drug, and Cosmetic Act (FFDCA).
DATES: Comments, identified by the docket number [PP 5E4472/P667], must
be received on or before July 26, 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 Highway, Arlington, VA.
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 Virginia 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: opp-docket@epamail.epa.gov. 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 5E4472/P667]. No 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 below in this document.
FOR FURTHER INFORMATION CONTACT: By mail: Amelia M. Acierto,
Registration Support Branch, Registration Division (7505W), Office of
Pesticide Programs, Environmental Protection Agency, 401 M St., SW.,
Washington, DC 20460. Office location, telephone number, and e-mail
address: 2800 Crystal Drive, North Tower, Arlington, VA, (703)308-8375,
e-mail: acierto.amelia@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: American Agricultural Services, Inc., 404 E.
Chatham St., Cary, NC 27511, has submitted pesticide petition (PP)
5E4472 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(d) by establishing an exemption from
the requirement of a tolerance for copper 8-quinolinolate (CAS Reg. No.
10380-28-6) when used as an inert ingredient (preservative) in
pesticidally treated paper products used on growing crops under 40 CFR
180.1001(d).
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 copper 8-quinolinolate
will need to be submitted. The rationale for this decision is described
below:
1. Copper 8-quinolinolate is cleared by the U.S. Food and Drug
Administration (FDA) as an indirect food additive for use as a
component in food packaging adhesives [21 CFR 175.105(c)]; in paper and
paperboard in contact with aqueous and fatty foods (21 CFR 176.170);
and in paper and paperboard in contact with dry foods (21 CFR 176.180).
2. Copper 8-quinolinolate is currently registered under the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA) as a fungicide/
preservative for (a) wood treatment including food contact surfaces,
for fruit and vegetable, food and feed containers, and bushel baskets
to protect the wood against mold, mildew, wood rot/decay fungi and wood
stain fungi; (b) agricultural paper mulch to protect against mildew,
fungal rot/decay (c) potato storage, handling, cutting and planting
equipment to protect against bacterial ring rot; and (d) for fabric,
cardboard and paper to protect against mold/mildew.
3. The toxicity data available from the open literature indicates
that copper 8-quinolinolate has a moderate acute toxicity in mice when
administered by intraperitoneal injection; it gave negative results in
a limited mice oral carcinogenicity studies; and has weak mutagenicity
in a bacterial Ames test.
Based on the expected low exposure and the similarity of the
proposed use pattern to the existing use, as an indirect food additive,
already approved by the FDA, and as an active ingredient registered
under FIFRA as preservative for wood, cardboard and paper intended for
storage and handling potatoes, fruits and vegetables, and the available
toxicology data, the 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 proposal be referred
to an Advisory Committee in
[[Page 33059]]
accordance with section 408(e) of FFDCA.
Interested persons are invited to submit written comments on the
proposed regulation. Comments must bear a notation indicating the
docket number, [PP 5E4472/P667].
A record has been established for this rulemaking under docket
number [PP 5E4472/P667] (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-docket@epamail.epa.gov
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 place the paper copies in the
official rulemaking record which will also include all comments
submitted directly in writing. The official rulemaking record is the
paper record maintained at the Virginia address in ``ADDRESSES'' at the
beginning of this document.
The Office of Management and Budget has exempted this proposed rule
from the requirements of section 3 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 1955 (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). Pursuant to the requirements of the Regulatory
Flexibility Act (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 explaining the factual basis for
this determination 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, Reporting and
recordkeeping requirements.
Dated: June 12, 1996.
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. In Sec. 180.1001 the table in paragraph (d) is amended by adding
alphabetically the inert ingredient Copper 8-quinolinolate (CAS Reg.
No. 10380-28-6), to read as follows:
Sec. 180.1001 Exemptions from the requirements of a tolerance.
* * * * *
(d) * * *
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Inert Ingredients Limits Uses
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Copper 8-quinolinolate (CAS Not to exceed 4% Preservative in
Reg. No. 10380-28-6). by weight of pesticidally treated
pesticide paper.
formulation.
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[FR Doc. 96-16334 Filed 6-25-96; 8:45 am]
BILLING CODE 6560-50-F
