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Watermelon Mosaic Virus-2 Coat Protein, Zucchini Yellow Mosaic Virus Coat Protein, and the Genetic Material Necessary for Production of These Proteins in Transgenic Squash Plants; Tolerance Exemption

Note: EPA no longer updates this information, but it may be useful as a reference or resource.

 [Federal Register: November 2, 1994]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[PP 4E4310/R2078; FRL-4908-1]
RIN 2070-AB78
 
Watermelon Mosaic Virus-2 Coat Protein, Zucchini Yellow Mosaic 
Virus Coat Protein, and the Genetic Material Necessary for Production 
of These Proteins in Transgenic Squash Plants; Tolerance Exemption

AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.

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SUMMARY: This document establishes an exemption from the requirement of 
a tolerance under the Federal Food, Drug, and Cosmetic Act for residues 
of the plant pesticides watermelon mosaic virus-2 (WMV2) coat protein 
and zucchini yellow mosaic virus (ZYMV) coat protein, as expressed in 
Asgrow line ZW20 of Cucurbita pepo L. and the genetic material 
necessary for the production of these proteins. Asgrow Seed Co. 
petitioned EPA for the exemption.

EFFECTIVE DATE: This regulation becomes effective November 2, 1994.

ADDRESSES: Written objections and hearing requests, identified by the 
document control number, [PP 4E4310/R2078], 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 (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.

FOR FURTHER INFORMATION CONTACT: By mail: Leonard S. Cole, Acting 
Product Manager (PM) 21, Registration Division (7505C), Environmental 
Protection Agency, 401 M St., SW., Washington, DC 20460. Office 
location and telephone number: Rm. 227, 1921 Jefferson Davis Hwy., 
Arlington, VA 22202, (703)-305-6900.

SUPPLEMENTARY INFORMATION: In the Federal Register of July 27, 1994 (59 
FR 38149), EPA issued a proposed rule that gave notice that the Asgrow 
Seed Co., Kalamazoo, MI 49004, had submitted pesticide petition (PP) 
4E4310 to EPA under section 408 of the Federal Food, Drug, and Cosmetic 
Act, 21 U.S.C. 346a, to exempt from the requirement of a tolerance the 
residues of the plant-pesticides watermelon mosaic virus-2 coat protein 
and zucchini yellow mosaic virus coat protein as expressed in Asgrow 
line ZW20 of Cucurbita pepo L., and subsequent generations obtained 
through normal sexual reproduction. An amendment to this petition was 
received on April 4, 1994, which changed the proposed exemption by 
including the genetic material necessary for the production of these 
proteins.
    There were no comments or requests for referral to an advisory 
committee received in response to the proposed rule. By way of public 
reminder, this notice also reiterates the registrant's responsibility, 
under section 6 (a)(2) of FIFRA, to submit additional factual 
information regarding adverse effects on the environment and to human 
health by the pesticide.
    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, the tolerance 
exemption is established as set forth below.
    Any person adversely affected by this regulation may, within 30 
days after publication of this document in the Federal Register, file 
written objections and/or request a hearing 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 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 issue(s) in the manner 
sought by the requestor would be adequate to justify the action 
requested (40 CFR 178.32).
    Under Executive Order 12866 (58 FR 51735, Oct. 4, 1993), the Agency 
must determine whether the regulatory action is ``significant'' and 
therefore subject to review by the Office of Management and Budget 
(OMB) and the requirements of the Executive Order. Under section 3(f), 
the order defines a ``significant regulatory action'' as an action that 
is likely to result in 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 
environment, public health or safety, or State, local, or tribal 
governments or communities (also referred to 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 the rights and obligations of recipients 
thereof; 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 the 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: October 17, 1994.

Daniel M. Barolo,
Director, 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. In subpart D, by adding new Sec. 180.1132, to read as follows:

Sec. 180.1132 Watermelon mosaic virus-2 coat protein, zucchini yellow 
mosaic virus coat protein, and the genetic material necessary for the 
production of these proteins; exemption from the requirement of a 
tolerance.

    The plant pesticides watermelon mosaic virus-2 coat protein and 
zucchini yellow mosaic virus coat protein as expressed in Asgrow line 
ZW20 of Cucurbita pepo L. and the genetic material (nucleic acids) 
necessary for the production of these proteins are exempted from the 
requirement of a tolerance in this transgenic plant and in subsequent 
generations of Asgrow line ZW20 of cucurbita pepo L. obtained through 
normal sexual reproduction.

[FR Doc. 94-26804 Filed 11-1-94; 8:45 am]
BILLING CODE 6560-50-F

 
 

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