[Federal Register Volume 64, Number 51 (Wednesday, March 17, 1999)]
[Rules and Regulations]
[Pages 13078-13080]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-6176]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300530A; FRL-6052-3]
RIN 2070-AB78
Potato Leaf Roll Virus Resistance Gene (also known as orf1/orf2
gene); Exemption from the Requirement of a Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule; Technical amendment.
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SUMMARY: EPA is issuing a technical amendment to a tolerance exemption
it published in the Federal Register on August 15, 1997 (62 FR 43650).
This technical amendment changes the name of the active ingredient from
``Replicase Protein of Potato Leaf Roll Virus and the genetic material
necessary for it's production'' to ``Potato Leaf Roll Virus Resistance
Gene (also known as orf1/orf2 gene) and the genetic material necessary
for it's production.'' This action is requested by Monsanto Company,
who originally filed the pesticide petition requesting an exemption
from the requirement of a tolerance for residues of the biological pest
control agent under the name ``Replicase Protein of Potato Leaf Roll
Virus and the genetic material necessary for it's production.'' The
change was suggested by the Agency as a result of the review of data
which indicated that the former active ingredient, Replicase Protein of
Potato Leaf Roll Virus and the genetic material necessary for it's
production, was not solely responsible for providing the plant product
with its' pesticidal properties (i.e., resistance to infection by the
Potato Leaf Roll Virus). Changing the active ingredient name in no way
changes the findings, determinations, or effects of the originally
issued final rule published in the Federal Register of August 15, 1997
(62 FR 43650).
DATES: This regulation is effective March 17, 1999. Objections and
requests for hearings must be received by EPA on or before May 17,
1999.
ADDRESSES: Written objections and hearing requests, identified by the
docket control number [OPP-300530A], 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) 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-00530A], 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,
Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA.
A copy of objections and hearing requests filed with the Hearing
Clerk may be submitted electronically 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 5.1/6.1 file format or ASCII file format. All
copies of electronic objections and hearing requests must be identified
by the docket number [OPP-300530A]. 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.
FOR FURTHER INFORMATION CONTACT: By mail: Linda Hollis, Product Manager
(PM) 90, Biopesticides and Pollution Prevention Division (7511C),
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460.
Office location, telephone number and e-mail address: 9th fl., Crystal
Mall #2 1921 Jefferson Davis Hwy., Arlington, VA 22202, (703)308-8733.
e-mail: [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of June 25, 1997 (62 FR 34283-34286) (FRL-
5728-4), EPA issued a notice pursuant to section 408 of the Federal
Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(e) announcing the
filing of a pesticide tolerance petition by Monsanto Company, St.
Louis, Missouri. This notice included a summary of the petition
prepared by the petitioner and this summary contained conclusions and
arguments to support its conclusion that the petition complied with the
Food Quality Protection Act (FQPA) of 1996. The petition requested that
40 CFR part 180 be amended by establishing an exemption from the
requirement of a tolerance for residues of the biological pest control
agent Replicase Protein of Potato Leaf Roll Virus and the genetic
material necessary for it's production in or on all food commodities.
EPA published a final rule establishing a tolerance exemption in the
Federal Register on August 15, 1997 (62 FR 43650) (FRL-5738-3) amending
40 CFR 180.1183. An amendment to this petition and thus the final rule
establishing a tolerance exemption, was requested by Monsanto Company
to change the name of the active ingredient from the above to Potato
Leaf Roll Virus Resistance Gene (also known as orf1/orf2 gene) and the
genetic material necessary for it's production. This request came at
the suggestion of the Agency as a result of the review of data which
indicated that the former active ingredient, ``Replicase Protein of
Potato leaf Roll Virus and the genetic material necessary for it's
production,'' was not solely responsible for providing the plant with
it's pesticidal properties (i.e., resistance to infection by the Potato
Leaf Roll Virus). A change in the name of the active ingredient will in
no way amend the text of the original petition or EPA's findings,
conclusions or determinations as described in the August 15, 1997 Final
Rule (62 FR 43650). Additionally, a change in the name of the active
ingredient does not affect and/or compromise the Agency's original
dietary risk exposure assessment which concluded that the active
ingredient posed no dietary risk of concern under normal conditions.
Therefore, this technical amendment only changes in the name of the
active ingredient. All other text remains the same as in the final rule
of August 15, 1997 (62 FR 43650) which amended 40 CFR 180.1183. For the
reasons set forth above, EPA believes that it is approprate to issue
this rule as a technical amendment. Because this amendment makes a
minor corrective change to an existing regulation and has no
substantive impact, EPA has determined that good cause exists to
dispense with the notice and comment provisions of the Administrative
Procedure Act (APA)
[[Page 13079]]
pursuant to 5 U.S.C. 553(b)(B). Section 408 of the FFDCA provides that
the Administrator, before issuing a comment unless the Administrator
for good cause finds that it would be in the public interest to provide
a shorter period. EPA has determined that there is good cause for
making today's rule final without prior proposal and opportunity for
comment because EPA is merely correcting the name of a chemical for
which a tolerance exemption has already been issued. Thus, notice and
public procedure are unnecessary. The Agency finds that this
constitutes good cause under section 408(e)(2). Under section 408(g)(1)
of the FFDCA, today's rule is effective upon publication.
II. Objections and Hearing Requests
The new FFDCA section 408(g) provides essentially the same process
for persons to ``object'' to a regulation for an exemption from the
requirement of a tolerance issued by EPA under new section 408(d)and 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 governs 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 May 17, 1999, 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 under the ``ADDRESSES'' section (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(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 issues(s) 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.
III. Public Record and Electronic Submissions
EPA has established a record for this rulemaking under docket
control number [OPP-300530A]. 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 22202.
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, is kept in paper form. Accordingly, in the
event there are objections and hearing request, 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. The official rulemaking
record is the paper record maintained at the Virginia address in
``ADDRESSES'' at the beginning of this document.
IV. Regulatory Assessment Requirements
This final rule does not impose any new requirements. It only
implements a technical correction to the Code of Federal Regulations
(CFR). As such, this action does not require review by the Office of
Management and Budget (OMB) under Executive order 12866, entitled
Regulatory Planning and Review (58 FR 51735, October 4, 1993), the
Paperwork Reduction Act (PRA), 44 U.S.C. 3501., or Executive Order
13045, entitled Protection of Children from Environmental Health Risks
and Safety Risks (62 FR 19885, April 23, 1991). This action does not
impose any enforceable duty, contain any unfunded mandate, or impose
any significant or unique impact on small governments as described in
the Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 104-4). Nor
does it require prior consultation with State, local, and tribal
government officials as specified by Executive Order 12875, entitled
Enhancing the Intergovernmental Partnership (58 FR 58093, October 28,
1993) and Executive Order 13084, entitled Consultation and Coordination
with Indian Tribal Governments (63 FR 27655, May 19, 1998), or special
consideration of environmental justice related issues under Executive
Order 12898, entitled Federal Actions to Address Environmental Justice
in Minority Populations and Low-Income Populations (59 FR 7629,
February 16, 1994). This action does not involve any technical
standards that would require Agency consideration of voluntary
consensus standards pursuant to section 12(d) of the National
Technology Transfer and Advancement Act of 1995 (NTTAA), Pub. L. 104-
113, section 12(d) (15 U.S.C. 272 note). In addition, since this action
is not subject to notice-and-comment requirements under the
Administrative Procedure Act (APA) or any other statute, it is not
subject to the regulatory flexibility provisions of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et seq.)
V. Submission to Congress and the Comptroller General
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. Section 808 allows the issuing agency to make a good
cause finding that notice and public determinations must be supported
by a brief statement 5 U.S.C. 808(2). EPA has made such a good cause
finding for this final rule, and established an effective date of March
17, 1999. Pursuant to 5 U.S.C 808(2), this determination is
[[Page 13080]]
supported by the brief statement in Unit I. of this preamble. EPA will
submit 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 United States prior to publication of the rule in the
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: March 2, 1999.
Janet L. Andersen,
Director, Biopesticides and Pollution Prevention 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. 321(q), 346a and 371.
2. Section 180.1183 is revised to read as follows:
Sec. 180.1183 Potato Leaf Roll Virus Resistance Gene (also known as
orf1/orf2 gene) and the genetic material necessary for it's production;
Exemption from the requirement of a tolerance.
An exemption from the requirement of a tolerance is established for
residues of the biological plant pesticide Potato Leaf Roll Virus
Resistance Gene (also known as orf1/orf2 gene) and the genetic material
necessary for its production.
[FR Doc. 99-6176 Filed 3-16-99; 8:45 am]
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