[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]



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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300420; FRL-5361-2]


Potassium Citrate; Tolerance Exemption

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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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               
                                                                        
         *        *        *        *        *        *        *        
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[FR Doc. 96-8940 Filed 4-9-96; 8:45 am]
BILLING CODE 6560-50-F