[Federal Register Volume 61, Number 70 (Wednesday, April 10, 1996)]
[Proposed Rules]
[Pages 15911-15913]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-8940]
=======================================================================
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300420; FRL-5361-2]
Potassium Citrate; Tolerance Exemption
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: This document proposes that residues of potassium citrate (CAS
Reg. No. 866-84-2) be exempted from the requirement of a tolerance when
used as an inert ingredient (chelating agent and pH control) in
pesticide formulations applied to growing crops, raw agricultural
commodities after harvest, and animals. This proposed regulation was
requested by Monsanto Company and Zeneca Ag Products pursuant to the
Federal Food, Drug, and Cosmetic Act (FFDCA).
DATES: Comments, identified by the docket control number [OPP-300420],
must be received on or before May 10, 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, Crystal
Mall 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 address given above,
[[Page 15912]]
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 in 5.1 file format or ASCII file
format. All comments and data in electronic form must be identified by
the docket number, [OPP-300420]. 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: [email protected].
SUPPLEMENTARY INFORMATION: Monsanto Company, 700 14th Street, NW.,
Washington, DC 20005, has submitted pesticide petition (PP) 6E04607 and
Zeneca Ag Products, 1800 Concord Pike, Wilmington, DE 19850-5458, has
submitted pesticide petition (PP) 6E04637, 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(c) and (e) by establishing an exemption from the requirement
of a tolerance for potassium citrate when used as an inert ingredient
(chelating agent and pH control) in pesticide formulations applied to
growing crops, raw agricultural commodities after harvest, and 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 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 potassium citrate will
need to be submitted. The rationale for this decision is described
below:
1. Potassium citrate is a potassium salt of citric acid which is a
naturally occurring metabolite in plant and animal tissues.
2. Potassium citrate has been affirmed as generally recognized as
safe (GRAS) by the U.S. Food and Drug Administration (FDA) as a direct
human food ingredient when used as Multiple Purpose GRAS Food Substance
(21 CFR 184.1625). The conditions of use specify only that potassium
citrate is generally recognized as safe when used in accordance with
good manufacturing practice.
3. Other citrates are already exempt from the requirements of a
tolerance under 40 CFR 180.1001 when used as inert ingredient in
pesticide formulations applied to growing plants or to raw agricultural
commodities after harvest (citric acid and calcium citrate), to growing
plants only (sodium citrate) or to animals (citric acid). Furthermore,
other related citrates (triethyl citrate and dibasic ammonium citrate)
have been considered by the Agency as inert ingredients of minimal
concern (i.e., classified as List 4B inert ingredients).
Based on the extensive FDA review of potassium citrate, resulting
in this chemical being affirmed as GRAS, its structure and physico-
chemical properties, and the fact that other chemically related
citrates have also been approved for food use applications, the Agency
does not believe that a potential for significant hazard exists when
potassium citrate is used in accordance with good agricultural
practices. The Agency believes that 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 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 control number, [OPP-300420]. 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
4:30 p.m. Monday through Friday, except legal holidays.
A record has been established for this rulemaking under docket
number [OPP-300420] (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 MallCM #2, 1921 Jefferson Davis Highway, Arlington, VA.
Electronic comments can be sent directly to EPA at:
[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 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
[[Page 15913]]
the requirements of section 3 of Executive Order 12866.
Pursuant to the requirements of the Regulatory Flexibility Act
(Pub. L. 96-3 54, 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, Reporting and
recordkeeping requirements.
Dated: March 29, 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. Section 180.1001 is amended by adding alphabetically to the
tables in paragraphs (c) and (e) the inert ingredient ``Potassium
citrate (CAS Reg. No. 866-84-2)'' to read as follows:
Sec. 180.1001 Exemptions from the requirements of a tolerance.
* * * * *
(c) * * *
------------------------------------------------------------------------
Inert Ingredients Limits Uses
------------------------------------------------------------------------
* * * * * * *
Potassium citrate (CAS Reg. Chelating agent, pH
No. 866-84-2). control
* * * * * * *
------------------------------------------------------------------------
(e) * * *
------------------------------------------------------------------------
Inert Ingredients Limits Uses
------------------------------------------------------------------------
* * * * * * *
Potassium citrate (CAS Reg. Chelating agent, pH
No. 866-84-2). control
* * * * * * *
------------------------------------------------------------------------
[FR Doc. 96-8940 Filed 4-9-96; 8:45 am]
BILLING CODE 6560-50-F