[Federal Register Volume 61, Number 129 (Wednesday, July 3, 1996)]
[Rules and Regulations]
[Pages 34739-34741]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-16859]


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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180

[OPP-300420A; FRL-5381-5]
RIN 2070-AB78


Potassium Citrate; Tolerance Exemption

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This document establishes an exemption from the requirement of 
a tolerance for residues of potassium citrate (CAS Reg. No. 866-84-2), 
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 regulation was requested by 
Monsanto Company and Zeneca Ag Products, pursuant to the Federal Food, 
Drug, and Cosmetic Act (FFDCA).

EFFECTIVE DATE: This regulation becomes effective July 3, 1996.

ADDRESSES: Written objections, identified by the document control 
number, [OPP-300420A] may be submitted to: Hearing Clerk (1900), 
Environmental Protection Agency, Rm. M3708, 401 M St., SW., Washington, 
DC 20460. A copy of any objections and hearing requests filed with the 
Hearing Clerk should be identified by the document control number and 
submitted 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, bring copy of objections and hearing request to: Rm. 1132, 
CM#2, 1921 Jefferson Davis Hwy., Arlington, VA 22202. Fees accompanying 
objections shall be labeled ``Tolerance Petition Fees'' and forwarded 
to: EPA Headquarters Accounting Operations Branch, OPP (Tolerance 
Fees), P.O. Box 360277M, Pittsburgh, PA 15251.
    A copy of objections and hearing requests filed with the Hearing 
Clerk may also be submitted electronically by sending electronic mail 
(e-mail) to: opp-docket@epamail.epa.gov. Copies of objections and 
hearing requests must be submitted as an ASCII file avoiding the use of 
special characters and any form of encryption. Copies of objections and 
hearing requests will also be accepted on disks in WordPerfect in 5.1 
file format or ASCII file format. All copies of objections and hearing 
requests in electronic form must be identified by the docket number 
[OPP-300420A]. No ``Confidential Business Information'' (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 and telephone number: Westfield 
Building North, 6th Fl., 2800 Crystal Drive, Arlington, VA 22202, (703) 
308-8375; e-mail: acierto.amelia@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: In the Federal Register of April 10, 1996 
(61 FR 15915), EPA issued a proposed rule (FRL-5361-2) gave notice that 
Monsanto Company, 700 14th Street, NW., Washington, DC 20005 had 
submitted pesticide petition (PP) 6E4607 and Zeneca Ag Products, 1800 
Concord Pike, Wilmington, DE 19850-5458 had submitted pesticide 
petition (PP) 6E4637 to EPA requesting that the

[[Page 34740]]

Administrator, pursuant to section 408(e) of the Federal Food, Drug, 
and Cosmetic Act (FFDCA), 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 residues of potassium citrate (CAS Reg. No. 866-84-
2) 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.
    There were no comments or requests for referral to an advisory 
committee received in response to the proposed rule.
    The data submitted relevant to the proposal and other relevant 
material have been evaluated and discussed in the proposed rule. Based 
on the data and information considered, the Agency concludes that the 
tolerance exemption will protect the public health. Therefore, the 
tolerance exemption is established as set forth below.
    Any person adversely affected by this regulation may, within 30 
days after publication of this document in the Federal Register, file 
written objections and/or request a hearing with the Hearing Clerk, at 
the address given above (40 CFR 178.20). A copy of the objections and/
or hearing requests filed with the Hearing Clerk should be submitted to 
the OPP docket for this rulemaking. The objections submitted must 
specify the provisions of the regulation deemed objectionable and the 
grounds for the objections (40 CFR 178.25). Each objection must be 
accompanied by the fee prescribed by 40 CFR 180.33(i). If a hearing is 
requested, the objections must include a statement of the factual 
issue(s) on which a hearing is requested, the requestor's contentions 
on such issues, and a summary of any evidence relied upon by the 
objector (40 CFR 178.27). A request for a hearing will be granted if 
the Administrator determines that the material submitted shows the 
following: There is a genuine and substantial issue of fact; there is a 
reasonable possibility that available evidence identified by the 
requestor would, if established, resolve one or more of such issues in 
favor of the requestor, taking into account uncontested claims or facts 
to the contrary; and resolution of the factual issue(s) in the manner 
sought by the requestor would be adequate to justify the action 
requested (40 CFR 178.32).
    A record has been established for this rulemaking under docket 
number [OPP-300420A] (including objections and hearing requests 
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 public 
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 1B2, 1921 Jefferson Davis Highway, Arlington, VA.
    A copy of electronic objections and hearing requests filed with the 
Hearing Clerk can be sent directly to EPA at:

    opp-docket@epamail.epa.gov


    A copy of electronic objections and hearing requests filed with the 
Hearing Clerk 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 address in ``ADDRESSES'' at the 
beginning of this document.
    Under Executive Order 12866 (58 FR 51735, October 4, 1993), the 
Agency must determine whether the regulatory action is ``significant'' 
and therefore subject to all the requirements of the Executive Order 
(i.e., Regulatory Impact Analysis, review by the Office of Management 
and Budget (OMB)). Under section 3(f), the order defines 
``significant'' as those actions likely to lead to a rule (1) having an 
annual effect on the economy of $100 million or more, or adversely and 
materially affecting a sector of the economy, productivity, 
competition, jobs, the environment, public health or safety, or State, 
local or tribal governments or communities (also known as 
``economically significant''); (2) creating serious inconsistency or 
otherwise interfering with an action taken or planned by another 
agency; (3) materially altering the budgetary impacts of entitlement, 
grants, user fees, or loan programs; or (4) raising novel legal or 
policy issues arising out of legal mandates, the President's 
priorities, or the principles set forth in this Executive Order.
    Pursuant to the terms of this Executive Order, EPA has determined 
that this rule is not ``significant'' and is therefore not subject to 
OMB review.
    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 1995 (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).
    Under 5 U.S.C. 801(a)(1)(A) of the Administrative Procedure Act 
(APA) as amended by the Small Business Regulatory Enforcement Fairness 
Act of 1996 (Title II of Pub. L. 104-121, 110 Stat. 847), EPA submitted 
a report containing this rule and other required information to the 
U.S. Senate, the U.S. House of Representatives and the Comptroller 
General of the General Accounting Office prior to publication of the 
rule in today's Federal Register. This rule is (is not) a ``major 
rule'' as defined by 5 U.S.C. 804(2) of the APA as amended.
    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 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.


[[Page 34741]]


    Dated: June 24, 1996.

Peter Caulkins,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR part 180 is 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 to paragraph (c) and (e) is amended 
by adding alphabetically the inert ingredient, to read as follows:


Sec. 180.1001   Exemptions from the requirement 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. 96-16859 Filed 7-2-96; 8:45 am]
BILLING CODE 6560-50-F