[Federal Register Volume 61, Number 31 (Wednesday, February 14, 1996)]
[Rules and Regulations]
[Pages 5712-5714]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-3021]



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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180

[OPP-300399A; FRL-4987-7
RIN 2070-AB78


Octadecanoic Acid, 12-Hydroxy-, Homopolymer, Octadecanoate; 
Tolerance Exemption

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This rule establishes an exemption from the requirement of a 
tolerance for residues of octadecanoic acid, 12-hydroxy-, homopolymer, 
octadecanoate (CAS Reg. No. 58128-22-6) when used as an inert 
ingredient (surfactant and dispersing agent) in pesticide formulations 
applied to growing crops or to raw agricultural commodities after 
harvest, under 40 CFR 180.1001(c). ICI Americas, Inc., requested this 
regulation pursuant to the Federal Food, Drug and Cosmetic Act (FFDCA).

EFFECTIVE DATE: This regulation becomes effective February 14, 1996.

ADDRESSES:  Written objections and hearing requests, identified by the 
document control number, [OPP-300399A], 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 

[[Page 5713]]
(7506C), Office of Pesticide Programs, Environmental Protection Agency, 
401 M St., SW., Washington, DC 20460. In person, bring copy of 
objections and hearing requests 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.
    An electronic copy of objections and hearing requests filed with 
the Hearing Clerk may be submitted to OPP by sending electronic mail 
(e-mail) to:
    [email protected]
    Copies of electronic objections and hearing requests must be 
submitted as an ASCII file avoiding the use of special characters and 
any form of encryption. Copies of electronic objections and hearing 
requests will also be accepted on disks in WordPerfect 5.1 file format 
or ASCII file format. All copies of electronic objections and hearing 
requests must be identified by the docket number [OPP-300399A] . No 
Confidential Business Information (CBI) should be submitted through e-
mail. Copies of electronic objections and hearing requests on this 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: Rita Kumar, Registration 
Support Branch, Registration Division (7505W), Environmental Protection 
Agency, 401 M St., SW., Washington, DC 20460. Office location and 
telephone number: 2800 Crystal Drive, North Tower, 6th Floor, 
Arlington, VA 22202, (703)-308-8811; e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: EPA issued a proposed rule, published in the 
Federal Register of October 25, 1995 (60 FR 54641), which announced 
that ICI Americas, Inc., Concord Plaza, 3411 Silverside Rd., P.O. Box 
15391, Wilmington, DE 19850, had submitted pesticide petition (PP) 
5E04506 to EPA requesting that the Administrator, pursuant to section 
408(e) of the Federal Food, Drug and Cosmetic Act (FFDCA) (21 U.S.C. 
346a(e)), amend 40 CFR 180.1001(c) by exempting octadecanoic acid, 12-
hydroxy-, homopolymer, octadecanoate from the requirement of a 
tolerance when used as an inert ingredient (surfactant and dispersing 
agent) in pesticide formulations applied to growing crops or to raw 
agricultural commodiites after harvest, under 40 CFR 180.1001(c). The 
inert ingredient meets the definition of a polymer under 40 CFR 
723.250(b) and the criteria listed in 40 CFR 723.250(e) that define a 
chemical substance that poses no unreasonable risk under section 5 of 
the Toxic Substance Control Act (TSCA).
    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 alcohol and 
hydrocarbons; surfactants such as polyoxyethylene polymers and fatty 
acids; carriers such as clay and diatomaceouse 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 on 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, tolerance 
exemption is established as set forth below.
     In response to the proposed rule for this inert tolerance 
exemption action, the Agency received a comment from ICI Surfactants 
requesting the expansion of its uses to include suspending agent and 
related adjuvant of surfactant as well as surfactant and dispersing 
agent. The Agency has decided to make this expansion, accordingly, on 
the judgement that it poses no additional risk to humans or the 
environment.
    Any person adversely affected by this regulation may, within 30 
days after publication of this document in the Federal Register, file 
written objections to the regulation and may also request a hearing on 
those objections. Objections and hearing requests must be filed 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 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).
    EPA has established a record for this rulemaking under docket 
number [OPP-300399A] (including any comments and data submitted 
electronically). 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 1B2, 
1921 Jefferson Davis Highway, Arlington, VA.
    Electronic comments may 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 any copies of objections and hearing requests 
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 

[[Page 5714]]
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.
    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, Reporting and 
recordkeeping requirements.

    Dated: February 1, 1996.

Stephen L. Johnson,

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. Section 180.1001(c) is amended 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.

* * * * *
    (c) *  *  *

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       Inert ingredient             Limits                 Uses         
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         *        *        *        *        *        *        *        
Octadecanoic acid, 12-hydroxy-   ..............  dispersing agent,      
 , homopolymer, octadecanoate                     related adjuvant of   
 (CAS Reg. No. 58128-22-6),                       surfactants,          
 minimum number-average                           surfactant, suspending
 molecular weight 1,370..                         agent.                
                                                                        
         *        *        *        *        *        *        *        
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[FR Doc. 96-3021 Filed 2-13-96; 8:45 am]
BILLING CODE 6560-50-F