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

Federal RegisterMay 23, 1994

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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

This is a copy of a public record, reproduced as it was published. It is not legal advice, and it may not be the version a court would rely on. Check the official source before you cite it.

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