Planet Biotechnology, Inc.; Availability of an Environmental Assessment and Finding of No Significant Impact for a Field Release To Produce Antibodies in Genetically Engineered Nicotiana Hybrids, 8850-8851 [E8-2911]

Download as PDF 8850 Federal Register / Vol. 73, No. 32 / Friday, February 15, 2008 / Notices effective way possible, requires close coordination within the Federal Government of research, development, and testing efforts. APHIS is determined to cooperate actively with the Agricultural Research Service, EPA, the Office of Management and Budget, and others involved in this effort to find effective alternatives to methyl bromide quarantine uses. The most recent effort by APHIS to reduce quarantine use of methyl bromide is through cooperative work with the IPPC on a draft International Standard for Phytosanitary Measures (ISPM). This ISPM titled ‘‘Developing a Strategy to Reduce or Replace the Use of Methyl Bromide for Phytosanitary Purposes’’ has been under review since June 2007 by contracting parties to the IPPC. In a notice summarizing EPA comments on recent environmental impact statements and proposed regulations that was published in the Federal Register on July 20, 2007 (72 FR 39807–39808), EPA expressed a lack of objections to the draft SEIS and APHIS’ adoption of the IPPC Guidelines. The record of decision has been prepared in accordance with: (1) NEPA, (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 1), and (4) APHIS’ NEPA Implementing Procedures (7 CFR part 372). Done in Washington, DC, this 11th day of February 2008. Kevin Shea, Acting Administrator, Animal and Plant Health Inspection Service. [FR Doc. E8–2908 Filed 2–14–08; 8:45 am] BILLING CODE 3410–34–P DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service [Docket No. APHIS–2007–0029] Planet Biotechnology, Inc.; Availability of an Environmental Assessment and Finding of No Significant Impact for a Field Release To Produce Antibodies in Genetically Engineered Nicotiana Hybrids Animal and Plant Health Inspection Service, USDA. ACTION: Notice. rwilkins on PROD1PC63 with NOTICES AGENCY: SUMMARY: We are advising the public that we have prepared an environmental assessment for a proposed field release involving a Nicotiana hybrid line that has been genetically engineered to produce an antimicrobial antibody that binds to a bacterium (Streptococcus mutans) associated with tooth decay in humans. The purpose of this field release is to generate plant biomass from which the antibody will be extracted after harvest. The environmental assessment provides a basis for our VerDate Aug<31>2005 15:58 Feb 14, 2008 Jkt 214001 conclusion that this field release will not present a risk of introducing or disseminating a plant pest and will not have a significant impact on the quality of the human environment. Based on its finding of no significant impact, the Animal and Plant Health Inspection Service has determined that an environmental impact statement need not be prepared for this field release. EFFECTIVE DATE: February 15, 2008. ADDRESSES: You may read the environmental assessment (EA), the finding of no significant impact (FONSI), and the comments we received on this docket in our reading room. 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. The EA, FONSI and decision notice, and responses to comments are available on the Internet at: https:// www.aphis.usda.gov/brs/aphisdocs/ 05_35403r_ea.pdf. Other Information: Additional information about APHIS and its programs is available on the Internet at https://www.aphis.usda.gov. FOR FURTHER INFORMATION CONTACT: Dr. Margaret Jones, Biotechnology Regulatory Services, APHIS, 4700 River Road Unit 147, Riverdale, MD 20737– 1236; (301) 734–4880. To obtain copies of the EA, FONSI and decision notice, and responses to comments, contact Ms. Cynthia Eck at (301) 734–0667; e-mail: cynthia.a.eck@aphis.usda.gov. 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.’’ A permit must be obtained or a notification acknowledged before a regulated article may be introduced. The regulations set forth the permit application requirements and the notification procedures for the importation, interstate movement, or release in the environment of a regulated article. PO 00000 Frm 00007 Fmt 4703 Sfmt 4703 On December 21, 2005, the Animal and Plant Health Inspection Service (APHIS) received a permit application (APHIS No. 05–354–03r) from Planet Biotechnology, Inc., of Hayward, CA, for a field trial using a transgenic Nicotiana hybrid. Permit application 05–354–03r describes a Nicotiana hybrid line (Nicotiana tabacum X Nicotiana glauca), designated as 06PBCarHG1, that produces a chimeric antimicrobial antibody (trade name CaroRxTM) that binds to the bacterium (Streptococcus mutans) associated with tooth decay in humans. Expression of the gene sequence is controlled by the cauliflower mosaic virus (CaMV) promoter and terminated by NOS from Agrobacterium tumefaciens and utilizes the selectable marker NPTII from Escherichia coli. Constructs were inserted into the recipient organisms via a disarmed Agrobacterium tumefaciens vector system. The antibodies generated from this planting will be extracted after harvest. The subject Nicotiana hybrid is considered a regulated article under the regulations in 7 CFR part 340 because it has been genetically engineered using genetic sequences from plant pathogens. On June 13, 2007, APHIS published a notice 1 in the Federal Register (72 FR 32607–32608, Docket No. APHIS–2007– 0029) announcing the availability of an environmental assessment (EA) for the proposed release of a transgenic Nicotiana hybrid line. During the 30day comment period, APHIS received six comments. All six comments were opposed to APHIS’ issuance of this permit and genetically engineered crops in general, but only one raised specific issues regarding the EA. APHIS has provided responses to these comments as an attachment to the finding of no significant impact (FONSI). Pursuant to the regulations promulgated under the Plant Protection Act, APHIS has determined that this field release will not pose a risk of introducing or disseminating a plant pest. Additionally, based upon analysis described in the EA, APHIS has determined that the action proposed in Alternative B of the EA (the preferred alternative), to issue the permit with supplemental permit conditions, will not have a significant impact on the quality of the human environment. Therefore, APHIS has determined that a FONSI is appropriate for this proposed action. You may read the FONSI and Decision Notice on the Internet or in the 1 To view the notice, the EA, and the comments we received, go to https://www.regulations.gov/ fdmspublic/component/ main?main=DocketDetail&d=APHIS-2007-0029. E:\FR\FM\15FEN1.SGM 15FEN1 Federal Register / Vol. 73, No. 32 / Friday, February 15, 2008 / Notices APHIS reading room (see ADDRESSES above). Copies may also be obtained from the person listed under the FOR FURTHER INFORMATION CONTACT section of this notice. The EA and FONSI were 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). 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 11th day of February 2008. Kevin Shea, Acting Administrator, Animal and Plant Health Inspection Service. [FR Doc. E8–2911 Filed 2–14–08; 8:45 am] BILLING CODE 3410–34–P DEPARTMENT OF AGRICULTURE Grain Inspection, Packers and Stockyards Administration David R. Shipman, Acting Administrator, Grain Inspection, Packers and Stockyards Administration. [FR Doc. E8–2949 Filed 2–14–08; 8:45 am] BILLING CODE 3410–KD–P DEPARTMENT OF AGRICULTURE Grain Inspection, Packers and Stockyards Administration, USDA. AGENCY: rwilkins on PROD1PC63 with NOTICES Notice correction. SUMMARY: On December 3, 2007, GIPSA published a notice in the Federal Register announcing that the designations of the following official agencies will end on June 30, 2008: Georgia Department of Agriculture (Georgia); Mid-Iowa Grain Inspection, Inc. (Mid-Iowa); and Montana Department of Agriculture (Montana). We asked persons interested in providing official services in the areas served by these agencies to submit an application for designation. The date that the applications and comments were due was incorrectly listed as January 2, 2009, instead of January 2, 2008. This notice provides interested persons a period of time to submit an application for designation or to comment on the official agencies named above. VerDate Aug<31>2005 15:58 Feb 14, 2008 Jkt 214001 Correction In the Federal Register issue of Monday, December 3, 2007, beginning on page 67885 (72 FR 67885) in make the following correction: 1. On page 67885, in the second column, delete the date January 2, 2009, and insert the date February 25, 2008. This action corrects the date, and allows an additional period for late applications and comments. Authority: 7 U.S.C. 71–87k. Correction of the December 3, 2007, Federal Register Notice Announcing Opportunities for Designation in Georgia, Cedar Rapids (IA), and the Montana Areas, and Request for Comments on the Official Agencies Serving These Areas ACTION: Applications and comments must be received by February 25, 2008. ADDRESSES: Karen Guagliardo, Review Branch Chief, Compliance Division, GIPSA, USDA, STOP 3604, Room 1647– S, 1400 Independence Avenue, SW., Washington, DC 20250–3604. Fax: (202) 690–2755, E-mail: Karen.W.Guagliardo@usda.gov. FOR FURTHER INFORMATION CONTACT: Karen Guagliardo at 202–720–7312, email Karen.W.Guagliardo@usda.gov. SUPPLEMENTARY INFORMATION: GIPSA is publishing this notice to correct an error concerning the date to submit applications for designation or to comment on the current official agencies serving the Georgia, Cedar Rapids (IA), and Montana areas. EFFECTIVE DATE: Grain Inspection, Packers and Stockyards Administration Opportunity To Comment on the Applicants for Maryland, New Jersey, and New York Grain Inspection, Packers and Stockyards Administration, USDA. ACTION: Notice and request for comments. AGENCY: SUMMARY: GIPSA requests comments on the applicants for designation to provide official services in Maryland, New Jersey, and New York. • Maryland Department of Agriculture (Maryland) applied for Maryland. • D. R. Schaal Agency, Inc. (Schaal) applied for New Jersey and New York. • Kankakee Grain Inspection, Inc. (Kankakee) applied for Maryland, New Jersey, and New York. • Mid-Iowa Grain Inspection, Inc. (Mid-Iowa) applied for Maryland, New Jersey and New York. PO 00000 Frm 00008 Fmt 4703 Sfmt 4703 8851 Comments must be postmarked or electronically dated on or before March 17, 2008. ADDRESSES: We invite you to submit comments on these applicants. You may submit comments by any of the following methods: • Hand Delivery or Courier: Deliver to Karen Guagliardo, Review Branch Chief, Compliance Division, GIPSA, USDA, Room 1647–S, 1400 Independence Avenue, SW., Washington, DC 20250. • Fax: Send by facsimile transmission to (202) 690–2755, attention: Karen Guagliardo. • E-mail: Send via electronic mail to Karen.W.Guagliardo@usda.gov. • Mail: Send hardcopy to Karen Guagliardo, Review Branch Chief, Compliance Division, GIPSA, USDA, STOP 3604, 1400 Independence Avenue, SW., Washington, DC 20250– 3604. • Federal eRulemaking Portal: Go to https://www.regulations.gov. Follow the online instructions for submitting comments and reading any comments posted online. Read Applications and Comments: All applications and comments will be available for public inspection at the office above during regular business hours (7 CFR 1.27(b)). FOR FURTHER INFORMATION CONTACT: Karen Guagliardo at 202–720–7312, email Karen.W.Guagliardo@usda.gov. SUPPLEMENTARY INFORMATION: This Action has been reviewed and determined not to be a rule or regulation as defined in Executive Order 12866 and Departmental Regulation 1512–1; therefore, the Executive Order and Departmental Regulation do not apply to this action. In the December 5, 2007, Federal Register (72 FR 68555), GIPSA asked persons interested in providing official services in Maryland, New Jersey, and New York to submit an application for designation. There were four applicants for the Maryland, New Jersey, and New York areas open for designation: Kankakee, Mid-Iowa, and Schaal, all currently designated official agencies, and Maryland, a state organization not currently designated. Kankakee and Mid-Iowa applied for Maryland, New Jersey, and New York. Schaal applied for New Jersey and New York. Maryland applied for Maryland. GIPSA is publishing this notice to provide interested persons the opportunity to present comments concerning the applicants. Commenters are encouraged to submit reasons and pertinent data for support or objection to the designation of the applicants. All DATES: E:\FR\FM\15FEN1.SGM 15FEN1

Agencies

[Federal Register Volume 73, Number 32 (Friday, February 15, 2008)]
[Notices]
[Pages 8850-8851]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-2911]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2007-0029]


Planet Biotechnology, Inc.; Availability of an Environmental 
Assessment and Finding of No Significant Impact for a Field Release To 
Produce Antibodies in Genetically Engineered Nicotiana Hybrids

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: We are advising the public that we have prepared an 
environmental assessment for a proposed field release involving a 
Nicotiana hybrid line that has been genetically engineered to produce 
an antimicrobial antibody that binds to a bacterium (Streptococcus 
mutans) associated with tooth decay in humans. The purpose of this 
field release is to generate plant biomass from which the antibody will 
be extracted after harvest. The environmental assessment provides a 
basis for our conclusion that this field release will not present a 
risk of introducing or disseminating a plant pest and will not have a 
significant impact on the quality of the human environment. Based on 
its finding of no significant impact, the Animal and Plant Health 
Inspection Service has determined that an environmental impact 
statement need not be prepared for this field release.

Effective Date: February 15, 2008.

ADDRESSES: You may read the environmental assessment (EA), the finding 
of no significant impact (FONSI), and the comments we received on this 
docket in our reading room. 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. The EA, FONSI and 
decision notice, and responses to comments are available on the 
Internet at: https://www.aphis.usda.gov/brs/aphisdocs/05_35403r_
ea.pdf.
    Other Information: Additional information about APHIS and its 
programs is available on the Internet at https://www.aphis.usda.gov.

FOR FURTHER INFORMATION CONTACT: Dr. Margaret Jones, Biotechnology 
Regulatory Services, APHIS, 4700 River Road Unit 147, Riverdale, MD 
20737-1236; (301) 734-4880. To obtain copies of the EA, FONSI and 
decision notice, and responses to comments, contact Ms. Cynthia Eck at 
(301) 734-0667; e-mail: cynthia.a.eck@aphis.usda.gov.

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.'' A permit must be 
obtained or a notification acknowledged before a regulated article may 
be introduced. The regulations set forth the permit application 
requirements and the notification procedures for the importation, 
interstate movement, or release in the environment of a regulated 
article.
    On December 21, 2005, the Animal and Plant Health Inspection 
Service (APHIS) received a permit application (APHIS No. 05-354-03r) 
from Planet Biotechnology, Inc., of Hayward, CA, for a field trial 
using a transgenic Nicotiana hybrid. Permit application 05-354-03r 
describes a Nicotiana hybrid line (Nicotiana tabacum X Nicotiana 
glauca), designated as 06PBCarHG1, that produces a chimeric 
antimicrobial antibody (trade name CaroRx\TM\) that binds to the 
bacterium (Streptococcus mutans) associated with tooth decay in humans. 
Expression of the gene sequence is controlled by the cauliflower mosaic 
virus (CaMV) promoter and terminated by NOS from Agrobacterium 
tumefaciens and utilizes the selectable marker NPTII from Escherichia 
coli. Constructs were inserted into the recipient organisms via a 
disarmed Agrobacterium tumefaciens vector system. The antibodies 
generated from this planting will be extracted after harvest.
    The subject Nicotiana hybrid is considered a regulated article 
under the regulations in 7 CFR part 340 because it has been genetically 
engineered using genetic sequences from plant pathogens.
    On June 13, 2007, APHIS published a notice \1\ in the Federal 
Register (72 FR 32607-32608, Docket No. APHIS-2007-0029) announcing the 
availability of an environmental assessment (EA) for the proposed 
release of a transgenic Nicotiana hybrid line. During the 30-day 
comment period, APHIS received six comments. All six comments were 
opposed to APHIS' issuance of this permit and genetically engineered 
crops in general, but only one raised specific issues regarding the EA. 
APHIS has provided responses to these comments as an attachment to the 
finding of no significant impact (FONSI).
---------------------------------------------------------------------------

    \1\ To view the notice, the EA, and the comments we received, go 
to https://www.regulations.gov/fdmspublic/component/
main?main=DocketDetail&d=APHIS-2007-0029.
---------------------------------------------------------------------------

    Pursuant to the regulations promulgated under the Plant Protection 
Act, APHIS has determined that this field release will not pose a risk 
of introducing or disseminating a plant pest. Additionally, based upon 
analysis described in the EA, APHIS has determined that the action 
proposed in Alternative B of the EA (the preferred alternative), to 
issue the permit with supplemental permit conditions, will not have a 
significant impact on the quality of the human environment. Therefore, 
APHIS has determined that a FONSI is appropriate for this proposed 
action. You may read the FONSI and Decision Notice on the Internet or 
in the

[[Page 8851]]

APHIS reading room (see ADDRESSES above). Copies may also be obtained 
from the person listed under the FOR FURTHER INFORMATION CONTACT 
section of this notice.
    The EA and FONSI were 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).

    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 11th day of February 2008.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
 [FR Doc. E8-2911 Filed 2-14-08; 8:45 am]
BILLING CODE 3410-34-P
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