[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]
BILLING CODE 6560-50-F