SemBioSys Genetics, Inc.; Availability of an Environmental Assessment and Finding of No Significant Impact for a Proposed Field Release of Genetically Engineered Safflower, 8847-8848 [E8-2910]

Download as PDF Federal Register / Vol. 73, No. 32 / Friday, February 15, 2008 / Notices 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. E8–2909 Filed 2–14–08; 8:45 am] BILLING CODE 3410–34–P DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service [Docket No. APHIS–2007–0023] SemBioSys Genetics, Inc.; Availability of an Environmental Assessment and Finding of No Significant Impact for a Proposed Field Release of Genetically Engineered Safflower Animal and Plant Health Inspection Service, USDA. ACTION: Notice. rwilkins on PROD1PC63 with NOTICES AGENCY: SUMMARY: We are advising the public that an environmental assessment has been prepared for a proposed field release of a safflower line genetically engineered to express, within its seeds, human proinsulin fused to an Arabidopsis oleosin molecule. After our assessment of the application, review of pertinent scientific information, and consideration of comments provided by the public, we have concluded that this field release will not present a risk of introducing or disseminating a plant pest, nor will it 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 these field releases. EFFECTIVE DATE: February 15, 2008. ADDRESSES: You may read the environmental assessment (EA), finding of no significant impact (FONSI), and any 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, VerDate Aug<31>2005 15:58 Feb 14, 2008 Jkt 214001 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/ 06_363103r_ea.pdf. FOR FURTHER INFORMATION CONTACT: Dr. Patricia Beetham, Biotechnology Regulatory Services, APHIS, 4700 River Road Unit 147, Riverdale, MD 20737– 1236; (301) 734–0664. To obtain copies of the EA, FONSI and decision notice, and response 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 18, 2006, the Animal and Plant Health Inspection Service (APHIS) received a permit application (APHIS No. 06–363–103r) from SemBioSys Genetics, Inc. of West Sacramento, CA, for a field trial using a line of transgenic safflower. Permit application 06–363–103r describes a transgenic safflower (Carthamus tinctorius) cultivar that has been genetically engineered to express a fusion protein consisting of oleosin from Arabidopsis thaliana and human proinsulin exclusively within its seeds. Expression of this fusion protein is controlled by the phaseolin promoter and terminator sequences from Phaseolus vulgaris L. (common bean). Constructs were inserted into the recipient organisms via a disarmed Agrobacterium tumefaciens vector system. The seeds from these safflower plants will be ground up and used for the development of proinsulin purification technology and are not for commercial production. The subject safflower is considered a regulated article under the regulations PO 00000 Frm 00004 Fmt 4703 Sfmt 4703 8847 in 7 CFR part 340 because it has been genetically engineered utilizing a recombinant DNA technique that uses a vector derived from Agrobacterium tumefaciens. On June 22, 2007, APHIS published a notice 1 in the Federal Register (72 FR 34426–34427, Docket No. APHIS–2007– 0023) announcing the availability of an environmental assessment (EA) for the proposed field release. During the 30day comment period, APHIS received seven comments. There was one individual who was opposed to the use of biotechnology in food crops in general, but did not cite specific plant pest risk issues associated with this EA. Another commenter raised specific issues regarding the EA that mirrored the concerns of one of the five public interest groups that also sent in comments on the EA. In total, five public interest groups wrote letters in opposition to allowing the planting of this GE safflower. APHIS has responded to these comments in an attachment to the finding of no significant impact (FONSI). Pursuant to the regulations in 7 CFR part 340 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 APHIS reading room (see ADDRESSES above). Copies of the EA are also available from the individual listed under FOR FURTHER INFORMATION CONTACT. 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). 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–2007–0023. E:\FR\FM\15FEN1.SGM 15FEN1 8848 Federal Register / Vol. 73, No. 32 / Friday, February 15, 2008 / Notices 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. E8–2910 Filed 2–14–08; 8:45 am] BILLING CODE 3410–34–P DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service [Docket No. APHIS–2006–0152] Importation of Solid Wood Packing Material; Record of Decision Animal and Plant Health Inspection Service, USDA. ACTION: Notice. rwilkins on PROD1PC63 with NOTICES AGENCY: SUMMARY: This notice advises the public of the Animal and Plant Health Inspection Service’s record of decision for the supplement to the Importation of Solid Wood Packing Material Final Environmental Impact Statement. ADDRESSES: Copies of the record of decision and the supplement to the final environmental impact statement on which the record of decision is based are available for public inspection 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. To be sure someone is there to help you, please call (202) 690– 2817 before coming. The record of decision may also be viewed on the APHIS Web site at https://www.aphis.usda.gov/ plant_health/ea/swpm.shtml. Supporting and related materials, including the final and supplemental environmental impact statements, may also be viewed on the Internet by visiting https://www.regulations.gov/ fdmspublic/component/ main?main=DocketDetail&d=APHIS2006-0152. FOR FURTHER INFORMATION CONTACT: Mr. David A. Bergsten, APHIS Interagency NEPA Contact, Environmental Services, PPD, APHIS, 4700 River Road, Unit 149, Riverdale, MD 20737–1238; (301) 734– 6103. SUPPLEMENTARY INFORMATION: This notice advises the public that the Animal and Plant Health Inspection Service (APHIS) has prepared a record of decision based on its supplemental environmental impact statement (SEIS) for the Importation of Solid Wood VerDate Aug<31>2005 15:58 Feb 14, 2008 Jkt 214001 Packing Material Final Environmental Impact Statement, August 2003 (FEIS). The SEIS and FEIS address Federal actions described in a final rule APHIS published in the Federal Register on September 16, 2004 (69 FR 55719– 55733, Docket No. 02–032–3). The final rule amended the regulations for the importation of unmanufactured wood articles to adopt an international standard entitled ‘‘Guidelines for Regulating Wood Packaging Material in International Trade.’’ The FEIS was prepared with regard to that final rule in compliance with the National Environmental Policy Act of 1969 (NEPA), as amended (42 U.S.C. 4321 et seq.), and its implementing regulations. On October 24, 2006, APHIS published in the Federal Register (71 FR 62240, Docket No. APHIS–2006– 0152) a notice of its intent to prepare the SEIS for the purpose of reevaluating and refining the estimates of methyl bromide usage associated with the alternatives considered in the FEIS. On March 9, 2007, the Environmental Protection Agency (EPA) published in the Federal Register (72 FR 10749) a notice of the availability of the draft SEIS. Comments were accepted on the draft SEIS until June 25, 2007. In October 2007, APHIS published and distributed the final SEIS, which included discussion of the three comments received on the draft SEIS. On November 23, 2007, EPA published in the Federal Register (72 FR 65732) a notice of the availability of the final SEIS. The NEPA implementing regulations at 40 CFR 1506.10 require a 30-day waiting period between the time a final EIS is published and the time an agency makes a decision on an action covered by the EIS. APHIS did not receive any comments on the final SEIS by the time this waiting period ended on December 24, 2007. APHIS has reviewed the final SEIS and has concluded that it has fully analyzed the issues covered by the draft SEIS and the comments and suggestions submitted by commenters. APHIS has now prepared a record of decision on the adopted SEIS and is making that record available to the public. The Record of Decision for the Importation of Solid Wood Packing Material Supplement to the Final Environmental Impact Statement, prepared pursuant to the Council on Environmental Quality’s NEPA implementing regulations at 40 CFR 1505.2, is set out below in its entirety. PO 00000 Frm 00005 Fmt 4703 Sfmt 4703 Record of Decision for the Importation of Solid Wood Packing Material Supplement to the Final Environmental Impact Statement This Record of Decision (ROD) has been developed in compliance with the agency decision-making requirements of NEPA. The purpose of this ROD is to document APHIS’ decision to adopt the September 16, 2004, final rule. Alternatives have been fully described and evaluated in the Supplement to the Final Environmental Impact Statement (SEIS) and in the Final Environmental Impact Statement (FEIS). This ROD is intended to: (a) State the APHIS decision, present the rationale for its selection, and describe its implementation; (b) identify the alternatives considered in reaching the decision; and (c) state whether all means to avoid or minimize environmental harm from implementation of the selected alternative have been adopted (40 CFR 1505.2). National Environmental Policy Act On November 23, 2007, the U.S. Environmental Protection Agency (EPA) published in the Federal Register [72 FR 65732] a notice of availability of the final supplement to the environmental impact statement titled ‘‘Importation of Solid Wood Packing Material.’’ The FEIS considered the environmental impacts from importation of wood packaging materials that could result from our adoption of the proposed rule. The SEIS reevaluates and refines the estimates of methyl bromide usage associated with the alternatives considered in the FEIS. Pursuant to the implementing regulations for NEPA in cases requiring an EIS, APHIS must prepare a record of decision to express the agency determination from review of the EIS documentation. The NEPA implementing regulations require that a record of decision state what decision is being made; identify alternatives considered in the environmental impact statement process; specify the environmentally preferred alternative; discuss preferences based on relevant factors—economic and technical considerations, as well as national policy considerations, where applicable; and state how all of the factors discussed entered into the decision. In addition, the record of decision must indicate whether the ultimate decision has been designed to avoid or minimize environmental harm and, if not, why not. The Decision This decision described in the ROD addresses impacts from the final rule published by APHIS in the Federal Register on September 16, 2004 (69 FR 55719–55733, Docket No. 02–032–3). After a thorough reevaluation and refinement of the estimates of methyl bromide usage associated with the alternatives considered in the FEIS and in the SEIS, APHIS has decided to continue to enforce the 2004 regulations that establish requirements stipulated in the International Plant Protection Convention (IPPC) guidelines for importation of wood packaging material into the United States from other countries. This includes specific treatment requirements for either heat treatment or fumigation with methyl bromide of the wood E:\FR\FM\15FEN1.SGM 15FEN1

Agencies

[Federal Register Volume 73, Number 32 (Friday, February 15, 2008)]
[Notices]
[Pages 8847-8848]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-2910]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2007-0023]


SemBioSys Genetics, Inc.; Availability of an Environmental 
Assessment and Finding of No Significant Impact for a Proposed Field 
Release of Genetically Engineered Safflower

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice.

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

SUMMARY: We are advising the public that an environmental assessment 
has been prepared for a proposed field release of a safflower line 
genetically engineered to express, within its seeds, human proinsulin 
fused to an Arabidopsis oleosin molecule. After our assessment of the 
application, review of pertinent scientific information, and 
consideration of comments provided by the public, we have concluded 
that this field release will not present a risk of introducing or 
disseminating a plant pest, nor will it 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 these field releases.

EFFECTIVE DATE: February 15, 2008.

ADDRESSES: You may read the environmental assessment (EA), finding of 
no significant impact (FONSI), and any 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/06_363103r_
ea.pdf.

FOR FURTHER INFORMATION CONTACT: Dr. Patricia Beetham, Biotechnology 
Regulatory Services, APHIS, 4700 River Road Unit 147, Riverdale, MD 
20737-1236; (301) 734-0664. To obtain copies of the EA, FONSI and 
decision notice, and response 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 18, 2006, the Animal and Plant Health Inspection 
Service (APHIS) received a permit application (APHIS No. 06-363-103r) 
from SemBioSys Genetics, Inc. of West Sacramento, CA, for a field trial 
using a line of transgenic safflower. Permit application 06-363-103r 
describes a transgenic safflower (Carthamus tinctorius) cultivar that 
has been genetically engineered to express a fusion protein consisting 
of oleosin from Arabidopsis thaliana and human proinsulin exclusively 
within its seeds. Expression of this fusion protein is controlled by 
the phaseolin promoter and terminator sequences from Phaseolus vulgaris 
L. (common bean). Constructs were inserted into the recipient organisms 
via a disarmed Agrobacterium tumefaciens vector system. The seeds from 
these safflower plants will be ground up and used for the development 
of proinsulin purification technology and are not for commercial 
production.
    The subject safflower is considered a regulated article under the 
regulations in 7 CFR part 340 because it has been genetically 
engineered utilizing a recombinant DNA technique that uses a vector 
derived from Agrobacterium tumefaciens.
    On June 22, 2007, APHIS published a notice \1\ in the Federal 
Register (72 FR 34426-34427, Docket No. APHIS-2007-0023) announcing the 
availability of an environmental assessment (EA) for the proposed field 
release. During the 30-day comment period, APHIS received seven 
comments. There was one individual who was opposed to the use of 
biotechnology in food crops in general, but did not cite specific plant 
pest risk issues associated with this EA. Another commenter raised 
specific issues regarding the EA that mirrored the concerns of one of 
the five public interest groups that also sent in comments on the EA. 
In total, five public interest groups wrote letters in opposition to 
allowing the planting of this GE safflower. APHIS has responded to 
these comments in 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-2007-0023.
---------------------------------------------------------------------------

    Pursuant to the regulations in 7 CFR part 340 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 APHIS reading room (see 
ADDRESSES above). Copies of the EA are also available from the 
individual listed under FOR FURTHER INFORMATION CONTACT.
    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).


[[Page 8848]]


    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. E8-2910 Filed 2-14-08; 8:45 am]
BILLING CODE 3410-34-P
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