[Federal Register Volume 59, Number 238 (Tuesday, December 13, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-30570]


[[Page Unknown]]

[Federal Register: December 13, 1994]


[Docket No. 92-127-4]

 

Availability of Determination of Nonregulated Status for Virus 
Resistant Squash

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice.

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SUMMARY: We are advising the public of our determination that a 
genetically engineered, virus resistant yellow crookneck squash line 
designated ZW-20 squash is no longer considered a regulated article 
under our regulations governing the introduction of certain genetically 
engineered organisms. Our determination is based on our evaluation of 
data submitted by the Upjohn Company in its petition for a 
determination of the regulatory status of ZW-20 squash, an analysis of 
other scientific data, and our review of comments received from the 
public regarding the Upjohn petition. This notice also announces the 
availability of the written determination document and its associated 
environmental assessment and finding of no significant impact.

EFFECTIVE DATES: December 7, 1994.

ADDRESSES: The determination, an environmental assessment and finding 
of no significant impact, the petition, and all written comments 
received regarding the petition 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. Persons wishing to inspect those documents are requested to 
call in advance of visiting at (202) 690-2817.

FOR FURTHER INFORMATION CONTACT: Dr. James White, Chief, Plants Branch, 
Biotechnology Permits, BBEP, APHIS, USDA, P.O. Drawer 810, Riverdale, 
MD 20738. The telephone number for the agency contact will change when 
agency offices in Hyattsville, MD, move to Riverdale, MD, during 
January. Telephone: (301) 436-7612 (Hyattsville); (301) 734-7612 
(Riverdale). To obtain a copy of the Upjohn determination or the 
accompanying environmental documents, contact Ms. Kay Peterson at (301) 
436-7601 (Hyattsville) or (301) 734-7601 (Riverdale).

SUPPLEMENTARY INFORMATION:

Background

    On July 13, 1992, the Animal and Plant Health Inspection Service 
(APHIS) received a petition from the Upjohn Company (Upjohn) and its 
subsidiary, Asgrow Seed Company, of Kalamazoo, MI, seeking a 
determination that the ZW-20 virus resistant squash line no longer be 
considered a regulated article under APHIS' regulations in 7 CFR part 
340.
    On September 4, 1992, APHIS announced the receipt of the Upjohn 
petition in the Federal Register (57 FR 40632-40633, Docket No. 92-127-
1) and announced its intent to issue an interpretive ruling that the 
ZW-20 virus resistant squash does not present a plant pest risk and, 
therefore, would no longer be considered a regulated article. That 
notice also requested comments on APHIS' proposed interpretive ruling. 
After considering the 17 comments submitted during the 45-day comment 
period, of which 7 were in support of the petition and 10 in 
opposition, APHIS determined that it was in the public interest to 
reopen the comment period to seek additional comment on several 
scientific and technical issues raised by the commenters. The 
commenters expressed concerns in three major areas: (1) Will the 
introduction of the two viral coat protein genes increase the 
likelihood of the creation of new plant viruses; (2) could the 
introduction of two virus resistance genes cause squash to become a 
weed; and (3) would the virus resistance genes move to wild squash 
relatives and would this have a detrimental impact on these wild 
plants? A notice was published in the Federal Register on March 22, 
1993 (58 FR 15323, Docket No. 92-127-2), to reopen the comment period 
for an additional 60 days. Twelve comments were received, of which 10 
were in support and 2 were in opposition. The same major areas of 
concern expressed during the first comment period were again reflected 
in the two comments in opposition to the petition, with the addition of 
a statement that an environmental impact statement should be prepared 
in connection with commercial scale growth of the ZW-20 squash.
    Since the date of the original submission of Upjohn's petition, 
APHIS has formalized, under a ``Petition for Determination of 
Nonregulated Status'' (See 58 FR 17044-17059, Docket No. 92-156-2), the 
interpretive ruling procedure that was in place when the original 
petition for the ZW-20 squash was submitted.
    On May 23, 1994, APHIS published a third notice in the Federal 
Register (59 FR 26619-26620, Docket No. 92-127-3) to announce the 
availability of an environmental assessment (EA) and preliminary 
finding of no significant impact (FONSI) related to the proposed 
determination of nonregulated status for the ZW-20 squash, a public 
meeting in Washington, DC, on July 21, 1994, and a 45-day comment 
period ending July 7, 1994. The notice included the text of the 
preliminary FONSI that had been prepared by APHIS.
    At the public meeting on June 21, 1994, two speakers presented 
comments. One commenter supported the EA and preliminary FONSI; the 
other did not support the EA and preliminary FONSI. Both speakers also 
submitted written comments. During the 45-day comment period, APHIS 
received an additional 52 written comments from private individuals, 
universities, agricultural experiment stations, the cooperative 
extension service, public interest groups, industry, a trade 
association, and a Federal research laboratory. Twenty-three comments 
supported APHIS' findings in the EA and preliminary FONSI. Twenty-nine 
comments disagreed with APHIS' proposal to approve the Upjohn petition, 
while 23 were in favor of approval. The commenters in opposition to the 
petition again stressed concerns about the ecological safety of 
commercial scale growth of the ZW-20 squash, citing such risks as gene 
glow to wild squash, potential impacts on squash centers of diversity, 
the potential for increased weediness in wild squash, and the risk of 
creating new viruses. APHIS has prepared a detailed technical analysis 
of, and response to, those comments in the determination document, 
which is available upon request from the individual listed under FOR 
FURTHER INFORMATION CONTACT.

Analysis

    The crookneck squash (Cucurbita pepo L. cultivar YC77E ZW-20) (ZW-
20) developed by Upjohn resists infection by two plant viruses, 
zucchini yellow mosaic virus (ZYMV) and watermelon mosaic virus, type 
II (WMV2). ZW-20 squash was developed by engineering two plant virus 
genes, the coat protein (CP) genes of ZYMV and WMV2, into a line of 
yellow crookneck squash. In addition, the vector system used to 
transfer the viral CP genes into the recipient squash was derived from 
the bacterial plant pathogen Agrobacterium tumefaciens. Certain 
noncoding regulatory sequences were derived from plant pathogens, i.e. 
from A. tumefaciens and from cauliflower mosaic virus and cucumber 
mosaic virus.
    The ZW-20 squash has been considered a regulated article under the 
APHIS regulations in 7 CFR part 340 in part because of the use of CP 
genes, in part because of the derivation of the vector system, and in 
part because of use of noncoding regulatory sequences from plant 
pathogens. Field testing of the ZW-20 squash has been conducted since 
1990 at approximately 46 field sites in 10 States under 14 permits 
issued by APHIS. All field trials have been performed under conditions 
of reproductive confinement. Field data reports indicate no deleterious 
effects on plants, nontarget organisms, or the environment from these 
field tests.

Determination

    Based on an analysis of the information and data submitted by 
Upjohn, a review of scientific literature, and comments received from 
the public, APHIS has concluded that the ZW-20 squash is as safe to 
grow as traditionally bred virus resistant squash. The available 
evidence indicates that ZW-20 squash: (1) Exhibits no plant pathogenic 
properties; (2) is no more likely to become a weed than a virus 
resistant squash plant developed by traditional breeding techniques; 
(3) is unlikely to increase the weediness potential for any other 
cultivated plant or native wild species with which it can interbreed; 
(4) should not cause damage to processed agricultural commodities; (5) 
should not increase the likelihood of the emergence of new plant 
viruses; and (6) is unlikely to harm other organisms, such as bees, 
which are beneficial to agriculture. The basic findings of the 
preliminary FONSI are therefore adopted in support of the determination 
that Upjohn's ZW-20 squash does not present a plant pest risk and 
therefore will no longer be considered a regulated article under APHIS' 
regulations in 7 CFR part 340. The effect of this determination is that 
the permit requirements of 7 CFR part 340 will no longer apply to the 
field testing, importation, or interstate movement of ZW-20 squash or 
its progeny. Importation of ZW-20 squash and nursery stock or seeds 
capable of propagation is still, however, subject to any restrictions 
found in the Foreign Quarantine Notice regulations at 7 CFR part 319.

National Environmental Policy Act

    The EA has 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). Based on that EA, APHIS reached a FONSI with 
regard to its determination that the virus resistant squash line 
designated as ZW-20 and its progeny are no longer regulated articles 
under its regulations in 7 CFR part 340. Copies of the EA and FONSI are 
available upon request from the individual listed under FOR FURTHER 
INFORMATION CONTACT.

    Done in Washington, DC, this 7th day of December 1994.
Terry L. Medley,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 94-30570 Filed 12-12-94; 8:45 am]
BILLING CODE 3410-34-P