[Federal Register Volume 63, Number 87 (Wednesday, May 6, 1998)]
[Rules and Regulations]
[Pages 24936-24939]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-11765]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300649; FRL-5787-9]
RIN 2070-AB78
Various Inert Ingredients; Tolerance Exemptions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes exemptions from the requirement of
a tolerance exemptions for residues of 2-
[[Page 24937]]
propene-1-sulfonic acid, sodium salt, polymer with ethenol and ethenyl
acetate; polyvinyl pyrrolidone butylated polymer; vinyl pyrrolidone-
acrylic acid copolymer; maleic anhydride-diisobutylene copolymer,
sodium salt; vinyl alcohol-vinyl acetate copolymer, benzaldehyde-o-
sodium sulfonate condensate when used as inert ingredients in pesticide
formulations applied to growing crops, crops after harvest, and/or
animals. EPA is establishing this regulation on its own initiative.
DATES: This regulation is effective May 6, 1998. Objections and
requests for hearings must be received by EPA on or before July 6,
1998.
ADDRESSES: Written objections and hearing requests, identified by the
docket control number, [OPP-300649], must be submitted to: Hearing
Clerk (1900), Environmental Protection Agency, Rm. M3708, 401 M St.,
SW., Washington, DC 20460. Fees accompanying objections and hearing
requests 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 any objections and
hearing requests filed with the Hearing Clerk identified by the docket
control number, [OPP-300649], must also be submitted to: Public
Information and Records Integrity Branch, Information Resources and
Services Division (7502C), Office of Pesticide Programs, Environmental
Protection Agency, 401 M St., SW., Washington, DC 20460. In person,
bring a copy of objections and hearing requests to Rm. 119, CM #2, 1921
Jefferson Davis Hwy., Arlington, VA.
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 5.1/6.1
file format or ASCII file format. All copies of objections and hearing
requests in electronic form must be identified by the docket control
number [OPP-300649]. No Confidential Business Information (CBI) should
be submitted through e-mail. Electronic copies of objections and
hearing requests on this rule may be filed online at many Federal
Depository Libraries.
FOR FURTHER INFORMATION CONTACT: By mail: Bipin Gandhi, 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: Crystal Mall #2, 1921 Jefferson
Davis Hwy., Arlington, VA, (703) 308-8380, e-mail:
gandhi.bipin@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: In the Federal Register of October 1, 1997
(62 FR 51397) (FRL-5746-3), EPA proposed the establishment of an
exemption from the requirement of a tolerance for residues of 2-
propene-1-sulfonic acid, sodium salt, polymer with ethenol and ethenyl
acetate; polyvinyl pyrrolidone butylated polymer; vinyl pyrrolidone-
acrylic acid copolymer; maleic anhydride-diisobutylene copolymer,
sodium salt; vinyl alcohol-vinyl acetate copolymer, benzaldehyde-o-
sodium sulfonate condensate when used as inert ingredients in pesticide
formulations applied to growing crops, raw agricultural commodities
after harvest and/or animals on its own initiative pursuant to section
408(e)(1)(B) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21
U.S.C. 346a(e). This proposal noted that these chemicals were the
subject of proposed rules published prior to the enactment of the Food
Quality Protection Act of 1996. Summaries of each of those initial
proposed rules were also included. There were no comments received in
response to the proposed rule.
Based on the information and data considered and the findings set
forth in the preamble to the proposed rule, EPA is establishing
exemptions from the requirement of a tolerance as set forth in this
document.
I. Objections and Hearing Requests
The new FFDCA section 408(g) provides essentially the same process
for persons to ``object'' to a tolerance regulation issued by EPA under
new section 408(e) and (l)(6) as was provided in the old section 408
and in section 409. However, the period for filing objections is 60
days, rather than 30 days. EPA currently has procedural regulations
which govern the submission of objections and hearing requests. These
regulations will require some modification to reflect the new law.
However, until those modifications can be made, EPA will continue to
use those procedural regulations with appropriate adjustments to
reflect the new law.
Any person may, by July 6, 1998, file written objections to any
aspect of this 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 issues on which a hearing is requested, the
requestor's contentions on such issues, and a summary of any evidence
relied upon by the requestor (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 issues in the manner sought by the requestor would be adequate
to justify the action requested (40 CFR 178.32). Information submitted
in connection with an objection or hearing request may be claimed
confidential by marking any part or all of that information as CBI.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2. A copy of the information that
does not contain CBI must be submitted for inclusion in the public
record. Information not marked confidential may be disclosed publicly
by EPA without prior notice.
II. Public Docket
EPA has established a record for this rulemaking under docket
control number [OPP-300649] (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 8:30 a.m.
to 4 p.m., Monday through Friday, excluding legal holidays. The public
record is located in Room 119 of the Public Information and Records
Integrity Branch, Information Resources and Services Division (7502C),
Office of Pesticide Programs, Environmental Protection Agency, Crystal
Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA.
Electronic comments may be sent directly to EPA at:
opp-docket@epamail.epa.gov.
[[Page 24938]]
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
Virginia address in ``ADDRESSES'' at the beginning of this document.
III. Regulatory Assessment Requirements
This final rule establishes an exemption from the requirement of a
tolerance under section 408(d) of the FFDCA in response to a petition
submitted to the Agency. The Office of Management and Budget (OMB) has
exempted these types of actions from review under Executive Order
12866, entitled Regulatory Planning and Review (58 FR 51735, October 4,
1993). This final rule does not contain any information collections
subject to OMB approval under the Paperwork Reduction Act (PRA), 44
U.S.C. 3501 et seq., or impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Pub. L. 104-4). Nor does it require any
prior consultation as specified by Executive Order 12875, entitled
Enhancing the Intergovernmental Partnership (58 FR 58093, October 28,
1993), or special considerations as required by Executive Order 12898,
entitled Federal Actions to Address Environmental Justice in Minority
Populations and Low-Income Populations (59 FR 7629, February 16, 1994),
or require OMB review in accordance with Executive Order 13045,
entitled Protection of Children from Environmental Health Risks and
Safety Risks (62 FR 19885, April 23, 1997).
The Regulatory Flexibility Act (RFA) 5 U.S.C. 605(b), as amended,
Pub. L. 104-121, 110 Stat. 847, generally requires an agency to prepare
a regulatory flexibility analysis of the impact of any notice and
comment rulemaking on small entities unless the agency certifies that
the rule will not have a significant economic impact on a substantial
number of small entities. Small entities include small businesses,
small not-for-profit enterprises, and small governmental jurisdictions.
The Agency has previously assessed whether establishing tolerances,
exemptions from tolerances, raising tolerance levels or expanding
exemptions might adversely impact small entities and concluded, as a
generic matter, that there is no adverse economic impact. The factual
basis for the Agency's generic certification for tolerance actions
published on May 4, 1981 (46 FR 24950) and was provided to the Chief
Counsel for Advocacy of the Small Business Administration. Therefore,
pursuant to section 605(b) of the RFA, EPA certifies that this rule
will not have a significant economic impact on a substantial number of
small entities. Accordingly, no final regulatory flexibility analysis
under section 604(a) of the Act is required.
IV. Submission to Congress and the General Accounting Office
Under 5 U.S.C. 801(a)(1)(A), as added by the Small Business
Regulatory Enforcement Fairness Act of 1996, the Agency has 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 this rule in
today's Federal Register. This is not a ``major rule'' as defined by 5
U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: April 22, 1998.
Peter Caulkins,
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I 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 tables in paragraphs (c) and (e) are
amended by adding alphabetically the following inert ingredients, and
the table in paragraph (d) is amended by removing the entry for
``Maleic anhydride diisobutylene copolymer, sodium salt'' to read as
follows:
Sec. 180.1001 Exemptions from the requirements of a tolerance.
* * * * *
(c) * * *
------------------------------------------------------------------------
Inert ingredients Limits Uses
------------------------------------------------------------------------
* * * * *
* *
Maleic anhydride- ............... Suspending agent and
diisobutylene copolymer, dispersing agent.
sodium salt (CAS Reg. No.
37199-81-8), minimum number
average molecular weight (in
amu) 5,000-18,000.
* * * * *
* *
Polyvinylpyrrolidone ............... Surfactants, related
butylated polymer (CAS Reg. adjuvant of surfactants
No. 26160-96-3), minimum and binder.
number average molecular
weight (in amu) 9,500.
* * * * *
* *
2-Propene-1-sulfonic acid ............... Binding agent.
sodium salt, polymer with
ethenol and ethenyl acetate,
number average molecular
weight (in amu) 6,000 -
12,000.
* * * * *
* *
Vinyl alcohol-vinyl acetate ............... Water soluble resin.
copolymer, benzaldehyde-o-
sodium sulfonate condensate,
minimum number average
molecular weight (in amu)
20,000.
[[Page 24939]]
* * * * *
* *
Vinyl pyrrolidone-acrylic ............... Adhesive, dispersion
acid copolymer (CAS Reg. No. stabilizer and coating
28062-44-4), minimum number for sustained release
average molecular weight (in granules.
amu) 6,000.
* * * * *
* *
------------------------------------------------------------------------
* * * * * * *
(e) * * *
------------------------------------------------------------------------
Inert ingredients Limits Uses
------------------------------------------------------------------------
* * * * *
* *
Maleic anhydride- ................ Suspending agent and
diisobutylene copolymer, dispersing agent.
sodium salt (CAS Reg. No.
37199-81-8), minimum number
average molecular weight (in
amu) 5,000-18,000.
* * * * *
* *
Polyvinylpyrrolidone ................ Surfactants, related
butylated polymer (CAS Reg. adjuvant of
No. 26160-96-3), minimum surfactants and
number-average molecular binder.
weight (in amu) 9,500.
* * * * *
* *
2-Propene-1-sulfonic acid ................ Binding agent.
sodium salt, polymer with
ethenol and ethenyl acetate,
number average molecular
weight (in amu) 6,000 -
12,000.
* * * * *
* *
Vinyl alcohol-vinyl acetate ................ Water soluble resin.
copolymer, benzaldehyde-o-
sodium sulfonate condensate,
minimum number average
molecular weight (in amu)
20,000.
* * * * *
* *
Vinyl pyrrolidone-acrylic, ................ Adhesive, dispersion
acid copolymer (CAS Reg. No. stabilizer and coating
28062-44-4), minimum number for sustained release
average molecular weight (in granules.
amu) 6,000.
* * * * *
* *
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[FR Doc. 98-11765 Filed 5-5-98; 8:45 am]
BILLING CODE 6560-50-F
