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Octadecanoic Acid, 12-Hydroxy-, Homopolymer, Octadecanoate; Tolerance Exemption
Note: EPA no longer updates this information, but it may be useful as a reference or resource.
[Federal Register: February 14, 1996 (Volume 61, Number 31)]
[Rules and Regulations]
[Page 5712-5714]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr14fe96-18]
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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:
opp-docket@epamail.epa.gov
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:
kumar.rita@epamail.epa.gov.
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:
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 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