Availability of an Environmental Assessment and Finding of No Significant Impact for a Field Release to Produce Antibodies in Genetically Engineered Tobacco, 38555-38556 [E7-13660]

Download as PDF Federal Register / Vol. 72, No. 134 / Friday, July 13, 2007 / Notices pwalker on PROD1PC71 with NOTICES We are asking the Office of Management (OMB) to approve our use of this information collection activity for an additional 3 years. The purpose of this notice is to solicit comments from the public (as well as affected agencies) concerning our information collection. These comments will help us: (1) Evaluate whether the collection of information is necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility; (2) Evaluate the accuracy of our estimate of the burden of the information collection, including the validity of the methodology and assumptions used; (3) Enhance the quality, utility, and clarity of the information to be collected; and (4) Minimize the burden of the information collection on those who are to respond, through use, as appropriate, of automated, electronic, mechanical, and other collection technologies, e.g., permitting electronic submission of responses. Estimate of burden: The public reporting burden for this collection of information is estimated to average 0.25 hours response. Respondents: Full-time salaried veterinary officials of exporting regions. Estimated annual number of respondents : 40. Estimated annual number of responses per respondent: 4. Estimated annual number of responses: 160. Estimated total annual burden on respondents: 40 hours. (Due to averaging, the total annual burden hours may not equal the product of the annual number of responses multiplied by the reporting burden per response.) All responses to this notice will be summarized and included in the request for OMB approval. All comments will also become a matter of public record. Done in Washington, DC, this 5th day of July 2007. Kevin Shea, Acting Administrator, Animal and Plant Health Inspection Service. [FR Doc. E7–13687 Filed 7–12–07; 8:45 am] BILLING CODE 3410–34–P VerDate Aug<31>2005 19:05 Jul 12, 2007 Jkt 211001 DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service [Docket No. APHIS–2006–0038] Availability of an Environmental Assessment and Finding of No Significant Impact for a Field Release to Produce Antibodies in Genetically Engineered Tobacco Animal and Plant Health Inspection Service, USDA. ACTION: Notice. AGENCY: SUMMARY: We are advising the public that we have prepared an environmental assessment for a field release involving a transgenic tobacco 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, we have determined that an environmental impact statement need not be prepared for this field release. EFFECTIVE DATE: July 13, 2007. ADDRESSES: You may read the final 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_35401r_ea.pdf. 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 environmental assessment, 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, PO 00000 Frm 00006 Fmt 4703 Sfmt 4703 38555 ‘‘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. 05–354–01r) from Planet Biotechnology, Inc. of Hayward, CA, for a field release using a line of transgenic tobacco. Permit application 05–354–01r describes a transgenic tobacco line (Nicotiana tabacum L.), designated as H8–105, 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 tobacco is considered a regulated article under the regulations in 7 CFR part 340 because it has been genetically engineered using the recombinant DNA technique using a vector derived from Agrobacterium tumefaciens. On March 27, 2007, APHIS published a notice 1in the Federal Register (72 FR 14259, Docket No. APHIS–2006–0038) announcing the availability of an environmental assessment (EA) for the proposed release of the transgenic tobacco line. During the 30-day 1 To view the notice, EA, and the comments we received, go to https://www.regulations.gov, click on the ‘‘Advanced Search’’ tab, and select ‘‘Docket Search.’’ In the Docket ID field, enter APHIS–2006– 0038, then click on ‘‘Submit.’’ Clicking on the Docket ID link in the search results page will produce a list of all documents in thedocket. E:\FR\FM\13JYN1.SGM 13JYN1 38556 Federal Register / Vol. 72, No. 134 / Friday, July 13, 2007 / Notices comment period, which ended on April 26, 2007, APHIS received two comments. Both comments were opposed to APHIS’ issuance of this permit and genetically engineered crops in general, but did not raise any specific issues regarding the EA. APHIS has provided responses to these comments as an appendix to the final EA. 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 the introduction or dissemination of a plant pest. Additionally, based upon analysis described in the final EA, APHIS has determined that the action proposed in Alternative C of the EA, issue the permit with supplemental permit conditions, will not have a significant impact on the quality of the human environment. You may read the finding of no significant impact (FONSI) and decision notice on the Internet or in the APHIS reading room (see ADDRESSES above). Copies may also be obtained from the person listed under FOR FURTHER INFORMATION CONTACT. The final 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 5th day of July 2007. Kevin Shea, Acting Administrator, Animal and Plant Health Inspection Service. [FR Doc. E7–13660 Filed 7–12–07; 8:45 am] BILLING CODE 3410–34–P 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 https:// 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. Dr. Michael Watson, Biotechnology Regulatory Services, APHIS, 4700 River Road Unit 147, Riverdale, MD 20737– 1236; (301) 734–0486, michael.t.watson@aphis.usda.gov. 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; cynthia.a.eck@aphis.usda.gov. The determination, petition, final EA, response to comments, and FONSI are also available on the Internet at https:// www.aphis.usda.gov/brs/aphisdocs/ 04_26401p.pdf and https:// FOR FURTHER INFORMATION CONTACT: DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service pwalker on PROD1PC71 with NOTICES [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 Animal and Plant Health Inspection Service, USDA. ACTION: Notice. AGENCY: VerDate Aug<31>2005 19:05 Jul 12, 2007 Jkt 211001 PO 00000 Frm 00007 Fmt 4703 Sfmt 4703 www.aphis.usda.gov/brs/aphisdocs/ 04_26401p_ea.pdf. 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. SUPPLEMENTARY INFORMATION: Background 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 E:\FR\FM\13JYN1.SGM 13JYN1

Agencies

[Federal Register Volume 72, Number 134 (Friday, July 13, 2007)]
[Notices]
[Pages 38555-38556]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-13660]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2006-0038]


Availability of an Environmental Assessment and Finding of No 
Significant Impact for a Field Release to Produce Antibodies in 
Genetically Engineered Tobacco

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 field release involving a transgenic 
tobacco 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, we have determined that an 
environmental impact statement need not be prepared for this field 
release.

EFFECTIVE DATE: July 13, 2007.

ADDRESSES: You may read the final 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_35401r_
ea.pdf.

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 environmental 
assessment, 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. 05-354-01r) 
from Planet Biotechnology, Inc. of Hayward, CA, for a field release 
using a line of transgenic tobacco. Permit application 05-354-01r 
describes a transgenic tobacco line (Nicotiana tabacum L.), designated 
as H8-105, 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 tobacco is considered a regulated article under the 
regulations in 7 CFR part 340 because it has been genetically 
engineered using the recombinant DNA technique using a vector derived 
from Agrobacterium tumefaciens.
    On March 27, 2007, APHIS published a notice \1\in the Federal 
Register (72 FR 14259, Docket No. APHIS-2006-0038) announcing the 
availability of an environmental assessment (EA) for the proposed 
release of the transgenic tobacco line. During the 30-day

[[Page 38556]]

comment period, which ended on April 26, 2007, APHIS received two 
comments. Both comments were opposed to APHIS' issuance of this permit 
and genetically engineered crops in general, but did not raise any 
specific issues regarding the EA. APHIS has provided responses to these 
comments as an appendix to the final EA.
---------------------------------------------------------------------------

    \1\ To view the notice, EA, and the comments we received, go to 
https://www.regulations.gov, click on the ``Advanced Search'' tab, 
and select ``Docket Search.'' In the Docket ID field, enter APHIS-
2006-0038, then click on ``Submit.'' Clicking on the Docket ID link 
in the search results page will produce a list of all documents in 
thedocket.
---------------------------------------------------------------------------

    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 the introduction or dissemination of a plant pest. 
Additionally, based upon analysis described in the final EA, APHIS has 
determined that the action proposed in Alternative C of the EA, issue 
the permit with supplemental permit conditions, will not have a 
significant impact on the quality of the human environment. You may 
read the finding of no significant impact (FONSI) and decision notice 
on the Internet or in the APHIS reading room (see ADDRESSES above). 
Copies may also be obtained from the person listed under FOR FURTHER 
INFORMATION CONTACT.
    The final 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 5th day of July 2007.
 Kevin Shea,
 Acting Administrator, Animal and Plant Health Inspection Service.
 [FR Doc. E7-13660 Filed 7-12-07; 8:45 am]
BILLING CODE 3410-34-P
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