[Federal Register Volume 59, Number 98 (Monday, May 23, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-12526]


[[Page Unknown]]

[Federal Register: May 23, 1994]


                                                    VOL. 59, NO. 98

                                               Monday, May 23, 1994

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service
[Docket No. 92-127-3]

 

Public Meeting; Availability of Environmental Assessment and 
Preliminary Finding of No Significant Impact for Determination of 
Nonregulated Status of Upjohn Co., ZW-20 Virus Resistant Squash

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice.

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SUMMARY: The Animal and Plant Health Inspection Service (APHIS) is 
announcing that a public meeting will be held to discuss an 
environmental assessment and preliminary finding of no significant 
impact prepared for a determination of nonregulated status for a 
genetically engineered virus-resistant squash line designated ``ZW-20 
squash.'' APHIS will be accepting public comments on the environmental 
assessment. APHIS has previously requested public comments on any plant 
pest risk issues presented by the ZW-20 squash. The environmental 
assessment and preliminary finding indicate no significant impact on 
the environment from the determination that the ZW-20 squash does not 
present a plant pest risk and should no longer be regulated under 
APHIS' regulations. Based on this preliminary finding of no significant 
impact, APHIS has determined that an environmental impact statement 
need not be prepared for the issuance of this determination.

DATES: The public meeting will be held in Washington, DC, on Tuesday, 
June 21, 1994, from 9 a.m. to 12:30 p.m. and 1:30 to 4 p.m. local time. 
Consideration will be given only to comments received on or before July 
7, 1994, regarding the environmental assessment.

ADDRESSES: The public meeting will be held in the Jefferson Auditorium, 
United States Department of Agriculture (USDA), South Building, 14th 
Street and Independence Avenue SW., Washington, DC. The following 
documents may be inspected at USDA, room 1141, South Building, 14th 
Street and Independence Avenue SW., Washington, DC, between 8 a.m. and 
4:30 p.m., Monday through Friday, except holidays: Copies of the 
environmental assessment and preliminary finding of no significant 
impact, the petition submitted by the Upjohn Company, and the comments 
received in response to our September, 1992, and March, 1993, Federal 
Register notices. Persons wishing to inspect these documents are 
requested to call ahead on (202) 690-2817.

FOR FURTHER INFORMATION CONTACT: Dr. James White, Biotechnology 
Permits, BBEP, APHIS, USDA, room 850 Federal Building, 6505 Belcrest 
Road, Hyattsville, MD 20782, (301) 436-7612. For a copy of the 
environmental assessment and preliminary finding of no significant 
impact, please call Ms. Kay Peterson at (301) 436-7601, or write to Ms. 
Peterson at this address.

SUPPLEMENTARY INFORMATION: On September 4, 1992, the Animal and Plant 
Health Inspection Service (APHIS) issued a notice of proposed 
interpretive ruling (57 FR 40632-40633, Docket No. 92-127-1) in 
response to a petition from the Upjohn Company (Upjohn), Kalamazoo, MI, 
for a determination of regulatory status of its ZW-20 virus-resistant 
squash line. After considering the comments submitted during the 30-day 
comment period, APHIS determined that it was in the public interest to 
reopen the comment period to examine scientific issues raised by the 
commenters. A notice was published in the Federal Register on March 22, 
1993 (58 FR 15323, Docket No. 92-127-2), requesting additional 
information on eight issues raised by respondents to Docket No. 92-127-
1. On March 31, 1993 (58 FR 17044-17059, Docket No. 92-156-2), APHIS 
amended its regulations in 7 CFR part 340 by establishing a petition 
process. The petition process allows for a determination that certain 
plants are no longer regulated articles, and formalizes the 
interpretive ruling procedure which was in place when the original 
petition for the ZW-20 squash was submitted. To provide for a thorough 
review of comments and information submitted to APHIS on the ZW-20 
squash, APHIS is convening a public meeting to provide a forum for an 
open discussion of the issues analyzed in the environmental assessment.

Procedures for the Public Meeting

    Any interested person may appear and may be heard in person, by 
attorney, or by other representative. The meeting will be held in the 
Jefferson Auditorium, United States Department of Agriculture (USDA), 
South Building, 14th Street and Independence Avenue SW., Washington, 
DC, on June 21, 1994, from 9 a.m. until 12:30 p.m. and from 1:30 p.m. 
until 4 p.m., local time. However, the meeting may conclude earlier if 
all persons who have requested an opportunity to speak have been heard. 
Persons who wish to speak should register at the meeting location with 
the presiding officer before the meeting. Pre-meeting registration will 
begin at 8 a.m., local time, on the day of the meeting at the meeting 
site. Persons who have registered will be heard in the order of their 
registration. Attendees who do not register in advance will be allowed 
to speak after all scheduled speakers have been heard. We ask that 
anyone who reads a statement provide two copies to the presiding 
officer at the meeting. The presiding officer may limit the time for 
each presentation in order to allow everyone wishing to speak the 
opportunity to be heard.

Environmental Assessment and Preliminary Finding of No Significant 
Impact

    APHIS regulations at 7 CFR part 340, which were promulgated 
pursuant to 7 U.S.C. 150aa-150jj, 151-167, and 1622n, and 31 U.S.C. 
9701, regulate the introduction (importation, interstate movement, and 
release into the environment) of certain genetically engineered 
organisms and products. The regulations at Sec. 340.6 provide for a 
petition process for issuing a determination that certain plants that 
do not present a plant pest risk no longer need to be regulated.
    The crookneck squash (Cucurbita pepo L. cultivar YC77E ZW-20)(ZW-
20), developed by Upjohn, has been considered a regulated article under 
7 CFR part 340, in part because it has been engineered with coat 
protein (CP) from watermelon mosaic virus 2 (WMV2) and zucchini yellow 
mosaic virus (ZYMV), and in part because the vector system used to 
transfer viral CP genes into the recipient squash was derived from the 
bacterial plant pathogen Agrobacterium tumefaciens. In addition, 
certain noncoding regulatory sequences were derived from plant 
pathogens, i.e., from A. tumefaciens and from cauliflower mosaic virus 
and cucumber mosaic virus. Field tests of the ZW-20 squash have been 
conducted under APHIS permits each year from 1990 through 1994 under 
conditions of reproductive confinement. The environmental assessments 
(EAs) prepared by APHIS in conjunction with the issuance of permits for 
field tests of ZW-20 have addressed various attributes of the squash 
line. The EA to be addressed at the public meeting examines the 
potential environmental impacts that might be associated with the 
unconfined cultivation of ZW-20 squash, as requested in the petition 
from Upjohn. The effect of a determination favorable to the petition 
would be that permits under the regulations would no longer be required 
from APHIS for field testing, importation, or interstate movement of 
these squash or their progeny. Importation of ZW-20 squash or seeds 
capable of propagation would still be subject to restrictions found in 
the Foreign Quarantine Notices at 7 CFR part 319. The findings that 
support a preliminary finding of no significant impact on the 
environment from a determination that the ZW-20 squash would no longer 
be a regulated article include the following:
    1. Growing ZW-20 squash would present no significant increase in 
the development of new plant viruses as compared to plants infected 
with both ZYMV and WMV2;
    2. The ability of ZW-20 squash to resist infection by WMV2 and ZYMV 
should not lead to this squash becoming a weed pest;
    3. Pollination of free-living Cucurbita pepo (FLCP) plants by the 
ZW-20 squash is not likely to increase the weediness of any resultant 
progeny;
    4. Introgression and maintenance of the virus resistance trait from 
ZW-20 squash into the gene pool of FLCP is unlikely. Based upon surveys 
of FLCP, the incidence of pathology or disease resulting from infection 
by ZYMV or WMV2 is not high enough to result in a selective pressure 
that would maintain the resistance genes in FLCP populations;
    5. APHIS cannot identify any impacts on nontarget organisms 
recognized as beneficial from the unconfined cultivation of ZW-20 
squash; and
    6. The release of ZW-20 squash from regulation would have no 
identifiable impact on agricultural commodities.
    The environmental assessment and preliminary finding of no 
significant impact have been prepared in accordance with: (1) The 
National Environmental Policy Act (NEPA) of 1969 (42 U.S.C. 4321 et 
seq.), (2) Regulations of the Council on Environmental Quality for 
Implementing the Procedural Provisions of NEPA (40 CFR parts 1500-
1508), (3) USDA Regulations Implementing NEPA (7 CFR part 1b), and (4) 
APHIS Guidelines Implementing NEPA (44 FR 50381-50384, August 28, 1979, 
and 44 FR 51272-51274, August 31, 1979).

    Done in Washington, DC, this 17th day of May 1994.
William S. Wallace,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 94-12526 Filed 5-20-94; 8:45 am]
BILLING CODE 3410-34-P