[Federal Register Volume 72, Number 134 (Friday, July 13, 2007)]
[Pages 38556-38557]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-13649]



Animal and Plant Health Inspection Service

[Docket No. APHIS-2006-0084]

U.S. Department of Agriculture, Agricultural Research Service; 
Determination of Nonregulated Status for Plum Genetically Engineered 
for Resistance to Plum Pox Virus

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice.


SUMMARY: We are advising the public of our determination that a plum 
line developed by the U.S. Department of Agriculture's Agricultural 
Research Service, designated as transformation event C5, which has been 
genetically engineered for resistance to infection by plum pox virus, 
is no longer considered a regulated article under agency regulations 
governing the introduction of certain genetically engineered organisms. 
Our determination is based on our evaluation of data submitted by the 
Agricultural Research Service in their petition for a determination of 
nonregulated status, an analysis of other scientific data, and comments 
received from the public in response to a previous notice announcing 
the availability of the petition and an environmental assessment. This 
notice also announces the availability of our written determination and 
our finding of no significant impact.

EFFECTIVE DATE: June 27, 2007.

ADDRESSES: You may read the petition, environmental assessment, 
determination, finding of no significant impact, the comments we 
received on our previous notice, and our responses to those comments in 
our reading room or on the Internet. The reading room is located in 
room 1141 of the USDA South Building, 14th Street and Independence 
Avenue, SW., Washington, DC. Normal reading room hours are 8 a.m. to 
4:30 p.m., Monday through Friday, except holidays. To be sure someone 
is there to help you, please call (202) 690-2817 before coming. To view 
those documents on the Internet, go to http://www.regulations.gov, 
click on the ``Advanced Search'' tab, and select ``Docket Search.'' In 
the Docket ID field, enter APHIS-2006-0084, then click ``Submit.'' 
Clicking on the Docket ID link in the search results page will produce 
a list of all documents in the docket.

FOR FURTHER INFORMATION CONTACT: Dr. Michael Watson, Biotechnology 
Regulatory Services, APHIS, 4700 River Road Unit 147, Riverdale, MD 
20737-1236; (301) 734-0486, [email protected]. To obtain 
copies of the determination, petition, final environmental assessment 
(EA), or the finding of no significant impact (FONSI), contact Ms. 
Cynthia Eck at (301) 734-0667; [email protected]. The 
determination, petition, final EA, response to comments, and FONSI are 
also available on the Internet at http://www.aphis.usda.gov/brs/aphisdocs/04_26401p.pdf and http://www.aphis.usda.gov/brs/aphisdocs/04_26401p_ea.pdf.

SUPPLEMENTARY INFORMATION: The regulations in 7 CFR part 340, 
``Introduction of Organisms and Products Altered or Produced Through 
Genetic Engineering Which Are Plant Pests or Which There Is Reason to 
Believe Are Plant Pests,'' regulate, among other things, the 
introduction (importation, interstate movement, or release into the 
environment) of organisms and products altered or produced through 
genetic engineering that are plant pests or that there is reason to 
believe are plant pests. Such genetically engineered organisms and 
products are considered ``regulated articles.''
    The regulations in 340.6(a) provide that any person may submit a 
petition to the Animal and Plant Health Inspection Service (APHIS) 
seeking a determination that an article should not be regulated under 7 
CFR part 340. Paragraphs (b) and (c) of 340.6 describe the form that a 
petition for a determination of nonregulated status must take and the 
information that must be included in the petition.


    On September 9, 2004, APHIS received a petition (APHIS Petition 
Number 04-264-01p) from the U.S. Department of Agriculture (USDA), 
Agricultural Research Service (ARS), Appalachian Fruit Research Station 
in Kearneysville, WV, requesting a determination of nonregulated status 
under 7 CFR part 340 for plum (Prunus domestica L.) designated as 
transformation event ARS-PLMC5-6 (C5), which has been genetically 
engineered to resist infection by plum pox virus (PPV). The ARS 
petition states that the subject plum should not be regulated by APHIS 
because it does not present a plant pest risk.
    As described in the petition, the C5 plum has been genetically 
engineered with a sequence from PPV. This sequence was derived from the 
viral coat protein gene. The resistance to plum pox infection appears 
to be conferred through post transcriptional gene silencing. As a 
result of this mechanism, no detectable viral coat protein is found in 
the subject plum.
    On May 16, 2006, APHIS published a notice in the Federal Register 
(71 FR 28296-28298, Docket No. APHIS-2006-0084) announcing the 
availability of the ARS petition and an environmental assessment (EA). 
APHIS solicited comments on whether the subject plum would present a 
plant pest risk and on the EA. APHIS received 1,725

[[Page 38557]]

comments by the close of the 60-day comment period, which ended on July 
17, 2006. There were 1,708 comments that were opposed to a 
determination of nonregulated status for the C5 plum and 17 comments 
that supported it. The majority of comments in opposition to 
deregulation were the same or similar and came from organic grower or 
consumer groups, individual organic growers, individuals who favor 
organic agriculture, or individuals who oppose genetic engineering in 
general. The majority of those comments supporting the determination of 
nonregulated status were from academic researchers and State farm 
bureaus. APHIS has addressed the issues raised during the comment 
period and has provided responses to these comments as attachments to 
the finding of no significant impact.


    Based on APHIS' analysis of the field, greenhouse, and laboratory 
data submitted by ARS, references provided in the petition, other 
relevant information described in the EA, and comments provided by the 
public, APHIS has determined that the C5 plum will not pose a plant 
pest risk for the following reasons: (1) The potential for gene flow 
and introgression are insignificant, therefore, the potential impacts 
from these are also insignificant; (2) the C5 plum is unlikely to 
thrive in unmanaged ecosystems, therefore, it is unlikely that there 
would be any weed impact from deregulation; (3) it does not produce any 
novel proteins or have any toxic properties that are likely to impact 
non-target organisms, including beneficial organisms and threatened or 
endangered species; (4) there is no apparent potential for significant 
impact on biodiversity; (5) the likelihood that the C5 plum would 
increase the development of new viruses or viruses with novel or 
altered properties is very low; and (6) if C5 plums were to be grown 
commercially, the impact on the environment would likely be no 
different than from cultivation of other domesticated plums.
    APHIS has concluded that the subject plum and any progeny derived 
from hybrid crosses with other non-transformed plum varieties will be 
no more of a plant pest than plum varieties in traditional breeding 
programs that are not subject to regulation under 7 CFR part 340. The 
effect of this determination is that ARS C5 plum is no longer 
considered a regulated article under APHIS' regulations in 7 CFR part 
340. Therefore, the requirements pertaining to regulated articles under 
those regulations no longer apply to the field testing, importation, or 
interstate movement of C5 plum or its progeny.

National Environmental Policy Act

    To provide the public with documentation of APHIS' review and 
analysis of any potential environmental impacts associated with the 
determination of nonregulated status for ARS C5 plum, an EA was 
prepared. The EA was prepared in accordance with (1) The National 
Environmental Policy Act of 1969 (NEPA), as amended (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' NEPA Implementing Procedures (7 CFR part 372). Based on that EA, 
APHIS has reached a finding of no significant impact with regard to the 
determination that ARS plum line C5 and lines developed from it are no 
longer regulated articles under its regulations in 7 CFR part 340. 
Copies of the EA and finding of no significant impact are available as 
of this notice.

    Authority: 7 U.S.C. 7701-7772 and 7781-7786; 31 U.S.C. 9701; 7 
CFR 2.22, 2.80, and 371.3.

    Done in Washington, DC, this 29th day of June 2007.
 Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
 [FR Doc. E7-13649 Filed 7-12-07; 8:45 am]