Availability of an Environmental Assessment and Finding of No Significant Impact for Field Release of Genetically Engineered Pink Bollworm, 20068-20069 [E6-5878]

Download as PDF 20068 Federal Register / Vol. 71, No. 75 / Wednesday, April 19, 2006 / Notices Estimated annual number of responses per respondent: 1. Estimated annual number of responses: 50. Estimated total annual burden on respondents: 12.5 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 13th day of April 2006. Kevin Shea, Acting Administrator, Animal and Plant Health Inspection Service. [FR Doc. E6–5880 Filed 4–18–06; 8:45 am] BILLING CODE 3410–34–P DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service [Docket No. APHIS–2006–0015] Availability of an Environmental Assessment and Finding of No Significant Impact for Field Release of Genetically Engineered Pink Bollworm Animal and Plant Health Inspection Service, USDA. ACTION: Notice. cchase on PROD1PC60 with NOTICES AGENCY: SUMMARY: We are advising the public that an environmental assessment has been prepared for a proposed field trial of pink bollworm genetically engineered to express green fluorescence as a marker. The Animal and Plant Health Inspection Service (APHIS) proposes to use this marked strain to assess the effectiveness of lower doses of radiation to create sterile insects for its pink bollworm sterile insect program. This program, using sterile insect technique, has been conducted by APHIS, with State and grower cooperation, since 1968. Data gained from this field experiment will be used to improve the current program. APHIS has completed an environmental assessment and has concluded that this field test will not have a significant impact on the quality of the human environment. Based on its finding of no significant impact, APHIS has determined that an Environmental Impact Statement need not be prepared for this field test. DATES: Effective Date: April 19, 2006. ADDRESSES: You may read the environmental assessment (EA), the finding of no significant impact (FONSI), and any comments that we VerDate Aug<31>2005 17:09 Apr 18, 2006 Jkt 208001 received on Docket No. APHIS–2006– 0015 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 responses to comments are also available on the Internet at https://www.aphis.usda.gov/ brs/aphisdocs/05_09801r_ea.pdf. FOR FURTHER INFORMATION CONTACT: Dr. Robyn Rose, Biotechnology Regulatory Services, APHIS, 4700 River Road Unit 147, Riverdale, MD 20737–1236; (301) 734–0489. To obtain copies of the EA, FONSI, and response to comments, contact Ms. Ingrid Berlanger at (301) 734–4885; e-mail: ingrid.e.berlanger@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 into the environment of a regulated article. On April 8, 2005, the Animal and Plant Health Inspection Service (APHIS) received a permit application (APHIS No. 05–098–01r) from APHIS’ Plant Protection and Quarantine (PPQ) Center for Plant Health Science and Technology (CPHST) Decision Support and Pest Management Systems Laboratory in Phoenix, AZ, for a field trial using the pink bollworm (PBW), Pectinophora gossypiella (Lepidoptera: Gelechiidae), that has been genetically engineered to express an enhanced green fluorescent protein (EGFP) derived from the jellyfish Aequora victoria. A piggyBac transposable element derived from the plant pest cabbage looper (Trichoplusia ni) was used to transform the subject PBW, and expression of the EGFP is controlled PO 00000 Frm 00002 Fmt 4703 Sfmt 4703 through use of a Bombyx mori cytoplasmic actin promoter. The subject transgenic PBW is considered a regulated article under the regulations in 7 CFR part 340 because the recipient organism is a plant pest. The proposed field test will evaluate the feasability of using F1 sterility systems in a sterile insect program, which is designed to depress PBW populations. The transgenic PBW will be reared in the Phoenix PBW genetic rearing facility and treated with radiation levels suitable to induce F1 sterility. The irradiated insects will be released into no more than four 3-acre field sites of cotton that are adjacent to cotton expressing the Bt toxin, which is toxic to PBW. This release is part of CPHST’s PBW sterile insect program. Information resulting from this research will be used in support of APHIS’ efforts to eradicate the PBW in the United States. Additional information on the PBW eradication plan for the United States may be found at https:// www.aphis.usda.gov/ppq/pdmp/cotton/ pinkbollworm/eradication/ eradication.pdf. An environmental assessment (EA) prepared for the Southwest Pink Bollworm Eradication Program may be found at https:// www.aphis.usda.gov/ppd/es/ pdf%20files/swpbwea.pdf. On February 13, 2006 APHIS published a notice 1 in the Federal Register (70 FR 7503–7504, Docket No. APHIS–2006–0015) announcing the availability of an EA for the proposed field trial. During the 30-day comment period, APHIS received two comments. One comment was from an individual and the other was from a government research scientist. One comment generally objected to the field release. The commenter made several unsupported, sweeping statements suggesting that the trial is poorly designed and will result in ‘‘health problems.’’ APHIS finds no basis for these statements and disagrees with the comment. Additionally, the commenter suggests that APHIS should be required to get ‘‘sign off of the neighbors.’’ APHIS has carefully evaluated the design of the field trial and has determined that it will not result in the establishment of the regulated article outside of the field test. Additionally, APHIS has informed the public of the proposed field test and requested comment on the EA. APHIS is confident that this field test will not 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– 0015, then click on ‘‘Submit.’’ Clicking on the Docket ID link in the search results page will produce a list of all documents in the docket. E:\FR\FM\19APN1.SGM 19APN1 cchase on PROD1PC60 with NOTICES Federal Register / Vol. 71, No. 75 / Wednesday, April 19, 2006 / Notices impact the human environment, including the neighbors, and has given adequate notice of the field test. The second comment supported the field trial described in the EA and suggested that the ‘‘* * * results will be vital to the progress of agricultural pest control.’’ APHIS agrees with the comment. Pursuant to its regulations (7 CFR part 340) promulgated under the Plant Protection Act, APHIS has determined that this field trial will not pose a risk of the introduction or dissemination of a plant pest for the following reasons: EGFP transgenic insects will not persist in the environment. They will be sterilized by irradiation and the EGFP transgenic insect’s fecundity in the EGFP PBW to be released is significantly lower than non-EGFP insects. Redundant mitigation measures are incorporated into the experimental procedures to ensure that genetically modified EGFP PBW will not become established in the environment. These measures are as follows: • All the surrounding cotton expresses Bacillus thuringiensis (Bt) toxin that kills PBW larvae. • There are no sexually compatible relatives of the PBW in the United States, so the transgene cannot spread via hybridization with other species. • The piggyBac-derived transposable element used to make the transforming construct has no functional transposase gene, thereby eliminating its ability to mobilize itself. • The release area will be monitored intensively with pheromone traps that attract and collect PBW male moths. Traps will be set up to 5 miles away from the site. • The area of release is less than 12 acres with no more than 3 acres per plot. • If adverse persistence is detected, unwanted bollworms will be killed with insecticides. Larvae from eggs oviposited on Bt cotton will not survive. • PBW populations can be suppressed by flooding the area with a high ratio of sterilized bollworms to field insects. • All moths will be securely managed and contained in production and transport using standard operating procedures with extremely high reliability developed for a long-running sterile insect technique program. • All living bollworms reared for this field trial that are not used as part of the environmental release will be killed. Based on the factors described above and the analysis contained in the EA, APHIS has determined that the proposed field trial will not have a VerDate Aug<31>2005 17:09 Apr 18, 2006 Jkt 208001 significant impact on the quality of the human environment. The EA and finding of significant impact 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). Copies of the EA and FONSI are available from the individual listed under FOR FURTHER INFORMATION CONTACT. 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 13th day of April 2006. Kevin Shea, Acting Administrator, Animal and Plant Health Inspection Service. [FR Doc. E6–5878 Filed 4–18–06; 8:45 am] BILLING CODE 3410–34–P DEPARTMENT OF AGRICULTURE Food Safety and Inspection Service [Docket No. FSIS–2006–0010] Codex Alimentarius Commission: Meeting of the Codex Committee on Methods of Analysis and Sampling Office of the Under Secretary for Food Safety, USDA. ACTION: Notice of public meeting and request for comments. AGENCY: SUMMARY: The Office of the Under Secretary for Food Safety, United States Department of Agriculture (USDA), and the Food and Drug Administration (FDA), U.S. Department of Health and Human Services (HHS), are sponsoring a public meeting on May 9, 2006. The objective of the public meeting is to provide information and receive public comments on agenda items and draft United States positions that will be discussed at the Twenty-seventh Session of the Codex Committee on Methods of Analysis and Sampling (CCMAS) of the Codex Alimentarius Commission (Codex), which will be held in Budapest, Hungary, May 15–19, 2006. The Under Secretary and FDA recognize the importance of providing interested parties the opportunity to obtain background information on the 27th Session of CCMAS and to address issues on the agenda. DATES: The public meeting is scheduled for Tuesday, May 9, 2006 from 10:30 a.m. to 12 p.m. PO 00000 Frm 00003 Fmt 4703 Sfmt 4703 20069 The public meeting will be held in the Conference Room 1A 002, Harvey W. Wiley Federal Building, 5100 Paint Branch Parkway, College Park, MD. Documents related to the 27th Session of CCMAS will be accessible via the World Wide Web at the following address: https:// www.codexalimentarius.net/ current.asp. The Food Safety and Inspection Service (FSIS) invites interested persons to submit comments on this notice. Comments may be submitted by any of the following methods: Federal eRulemaking Portal: This Web site provides the ability to type short comments directly into the comment field on this Web page or attach a file for lengthier comments. Go to https:// www.regulations.gov and, in the ‘‘Search for Open Regulations’’ box, select ‘‘Food Safety and Inspection Service’’ from the agency drop-down menu, then click on ‘‘Submit.’’ In the Docket ID column, select the FDMS Docket Number FSIS–2006–0010 to submit or view public comments and to view supporting and related materials available electronically. Mail, including floppy disks or CD– ROM’s, and hand-or courier-delivered items: Send to FSIS Docket Room, Docket Clerk, USDA, Food Safety and Inspection Service (FSIS), 300 12th Street, SW., Room 102, Cotton Annex Building, Washington, DC 20250. Electronic mail: fsis.regulationscomments@fsis.usda.gov. All submissions received must include the Agency name and docket number FSIS–2006–0010. All comments submitted in response to this notice, as well as research and background information used by FSIS in developing this document, will be posted to the regulations.gov Web site. The background information and comments also will be available for public inspection in the FSIS Docket Room at the address listed above between 8:30 a.m. and 4:30 p.m., Monday through Friday. In addition to submitting comments by mail to the above address, the U.S. Delegate to the CCMAS, Dr. Gregory Diachenko of the Food and Drug Administration, invites U.S. interested parties to submit their comments electronically to the following e-mail address (gregory.diachenko@fda.hhs.gov). Pre-Registration: To gain admittance to this meeting, individuals must present a photo ID for identification and also are required to pre-register. In addition, no cameras or videotaping equipment will be permitted in the meeting room. To pre-register, please ADDRESSES: E:\FR\FM\19APN1.SGM 19APN1

Agencies

[Federal Register Volume 71, Number 75 (Wednesday, April 19, 2006)]
[Notices]
[Pages 20068-20069]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-5878]


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

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2006-0015]


Availability of an Environmental Assessment and Finding of No 
Significant Impact for Field Release of Genetically Engineered Pink 
Bollworm

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 trial of pink bollworm 
genetically engineered to express green fluorescence as a marker. The 
Animal and Plant Health Inspection Service (APHIS) proposes to use this 
marked strain to assess the effectiveness of lower doses of radiation 
to create sterile insects for its pink bollworm sterile insect program. 
This program, using sterile insect technique, has been conducted by 
APHIS, with State and grower cooperation, since 1968. Data gained from 
this field experiment will be used to improve the current program. 
APHIS has completed an environmental assessment and has concluded that 
this field test will not have a significant impact on the quality of 
the human environment. Based on its finding of no significant impact, 
APHIS has determined that an Environmental Impact Statement need not be 
prepared for this field test.

DATES: Effective Date: April 19, 2006.

ADDRESSES: You may read the environmental assessment (EA), the finding 
of no significant impact (FONSI), and any comments that we received on 
Docket No. APHIS-2006-0015 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 responses to comments are also available on the 
Internet at https://www.aphis.usda.gov/brs/aphisdocs/05_09801r_ea.pdf.

FOR FURTHER INFORMATION CONTACT: Dr. Robyn Rose, Biotechnology 
Regulatory Services, APHIS, 4700 River Road Unit 147, Riverdale, MD 
20737-1236; (301) 734-0489. To obtain copies of the EA, FONSI, and 
response to comments, contact Ms. Ingrid Berlanger at (301) 734-4885; 
e-mail: ingrid.e.berlanger@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 into the environment of a regulated 
article.
    On April 8, 2005, the Animal and Plant Health Inspection Service 
(APHIS) received a permit application (APHIS No. 05-098-01r) from 
APHIS' Plant Protection and Quarantine (PPQ) Center for Plant Health 
Science and Technology (CPHST) Decision Support and Pest Management 
Systems Laboratory in Phoenix, AZ, for a field trial using the pink 
bollworm (PBW), Pectinophora gossypiella (Lepidoptera: Gelechiidae), 
that has been genetically engineered to express an enhanced green 
fluorescent protein (EGFP) derived from the jellyfish Aequora victoria. 
A piggyBac transposable element derived from the plant pest cabbage 
looper (Trichoplusia ni) was used to transform the subject PBW, and 
expression of the EGFP is controlled through use of a Bombyx mori 
cytoplasmic actin promoter.
    The subject transgenic PBW is considered a regulated article under 
the regulations in 7 CFR part 340 because the recipient organism is a 
plant pest. The proposed field test will evaluate the feasability of 
using F1 sterility systems in a sterile insect program, which is 
designed to depress PBW populations. The transgenic PBW will be reared 
in the Phoenix PBW genetic rearing facility and treated with radiation 
levels suitable to induce F1 sterility. The irradiated insects will be 
released into no more than four 3-acre field sites of cotton that are 
adjacent to cotton expressing the Bt toxin, which is toxic to PBW. This 
release is part of CPHST's PBW sterile insect program. Information 
resulting from this research will be used in support of APHIS' efforts 
to eradicate the PBW in the United States.
    Additional information on the PBW eradication plan for the United 
States may be found at https://www.aphis.usda.gov/ppq/pdmp/cotton/
pinkbollworm/eradication/eradication.pdf. An environmental assessment 
(EA) prepared for the Southwest Pink Bollworm Eradication Program may 
be found at https://www.aphis.usda.gov/ppd/es/pdf%20files/
swpbwea.pdf.
    On February 13, 2006 APHIS published a notice \1\ in the Federal 
Register (70 FR 7503-7504, Docket No. APHIS-2006-0015) announcing the 
availability of an EA for the proposed field trial. During the 30-day 
comment period, APHIS received two comments. One comment was from an 
individual and the other was from a government research scientist. One 
comment generally objected to the field release. The commenter made 
several unsupported, sweeping statements suggesting that the trial is 
poorly designed and will result in ``health problems.'' APHIS finds no 
basis for these statements and disagrees with the comment. 
Additionally, the commenter suggests that APHIS should be required to 
get ``sign off of the neighbors.'' APHIS has carefully evaluated the 
design of the field trial and has determined that it will not result in 
the establishment of the regulated article outside of the field test. 
Additionally, APHIS has informed the public of the proposed field test 
and requested comment on the EA. APHIS is confident that this field 
test will not

[[Page 20069]]

impact the human environment, including the neighbors, and has given 
adequate notice of the field test. The second comment supported the 
field trial described in the EA and suggested that the ``* * * results 
will be vital to the progress of agricultural pest control.'' APHIS 
agrees with the comment.
---------------------------------------------------------------------------

    \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-
2006-0015, then click on ``Submit.'' Clicking on the Docket ID link 
in the search results page will produce a list of all documents in 
the docket.
---------------------------------------------------------------------------

    Pursuant to its regulations (7 CFR part 340) promulgated under the 
Plant Protection Act, APHIS has determined that this field trial will 
not pose a risk of the introduction or dissemination of a plant pest 
for the following reasons:
    EGFP transgenic insects will not persist in the environment. They 
will be sterilized by irradiation and the EGFP transgenic insect's 
fecundity in the EGFP PBW to be released is significantly lower than 
non-EGFP insects. Redundant mitigation measures are incorporated into 
the experimental procedures to ensure that genetically modified EGFP 
PBW will not become established in the environment. These measures are 
as follows:
     All the surrounding cotton expresses Bacillus 
thuringiensis (Bt) toxin that kills PBW larvae.
     There are no sexually compatible relatives of the PBW in 
the United States, so the transgene cannot spread via hybridization 
with other species.
     The piggyBac-derived transposable element used to make the 
transforming construct has no functional transposase gene, thereby 
eliminating its ability to mobilize itself.
     The release area will be monitored intensively with 
pheromone traps that attract and collect PBW male moths. Traps will be 
set up to 5 miles away from the site.
     The area of release is less than 12 acres with no more 
than 3 acres per plot.
     If adverse persistence is detected, unwanted bollworms 
will be killed with insecticides. Larvae from eggs oviposited on Bt 
cotton will not survive.
     PBW populations can be suppressed by flooding the area 
with a high ratio of sterilized bollworms to field insects.
     All moths will be securely managed and contained in 
production and transport using standard operating procedures with 
extremely high reliability developed for a long-running sterile insect 
technique program.
     All living bollworms reared for this field trial that are 
not used as part of the environmental release will be killed.
    Based on the factors described above and the analysis contained in 
the EA, APHIS has determined that the proposed field trial will not 
have a significant impact on the quality of the human environment.
    The EA and finding of significant impact 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). Copies of the EA and FONSI are available 
from the individual listed under FOR FURTHER INFORMATION CONTACT.

    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 13th day of April 2006.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. E6-5878 Filed 4-18-06; 8:45 am]
BILLING CODE 3410-34-P
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