Receipt of a Notification to Conduct Small-Scale Field Testing of a Genetically-Engineered Microbial Pesticide; Notice of Availability

Note: EPA no longer updates this information, but it may be useful as a reference or resource.
 [Federal Register: June 6, 2001 (Volume 66, Number 109)]
[Notices]
[Page 30458-30460]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06jn01-98]

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ENVIRONMENTAL PROTECTION AGENCY
[OPP-00719; FRL-6783-2]
 
Receipt of a Notification to Conduct Small-Scale Field Testing of 
a Genetically-Engineered Microbial Pesticide; Notice of Availability

AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.

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SUMMARY:  This notice announces receipt from Dr. Brian A. Federick, of 
the Department of Entomology of the University of California, 
Riverside, of a notification (57109-NMP-R) of intent to conduct small-
scale field testing involving four modified strains of a microorganism, 
Bacillus thuringiensis subsp. israelensis H-14, ONR 60A (Bti). These 
modified strains of Bti have been genetically-engineered to express 
various combinations of mosquitocidal delta endotoxin proteins from Bti 
and the mosquitocidal binary protein toxin from Bacillus sphaericus. 
The proposed testing for control of various species of mosquitos will 
be in tanks and small enclosed artificial ponds. The Agency has 
determined that this notification may be of regional and national 
significance. Therefore in accordance with 40 CFR 172.11(a), the Agency 
is soliciting public comments on this notification.

DATE: Comments, identified by docket control number OPP-00719, must be 
received on or before July 6, 2001.

ADDRESSES: Comments may be submitted by mail, electronically, or in 
person. Please follow the detailed instructions for each method as 
provided in Unit I. of the SUPPLEMENTARY INFORMATION. To ensure proper 
receipt by EPA, it is imperative that you identify docket control 
number OPP-00719 in the subject line on the first page of your 
response.

FOR FURTHER INFORMATION CONTACT:  William R. Schneider, Biopesticides 
and

[[Page 30459]]

Pollution Prevention Division (7511C), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460; telephone number: (703) 308-8683; fax number: 
(703) 308-7026; e-mail address: schneider.william@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    This action is directed to the public in general. This action may, 
however, be of interest to those persons interested in small-scale 
field testing of genetically-engineered microbial pesticides or those 
persons who are or may be required to conduct testing of chemical 
substances under the Federal Food, Drug, and Cosmetic Act (FFDCA), or 
the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Since 
other entities may also be interested, the Agency has not attempted to 
describe all the specific entities that may be effected by this action. 
If you have any questions regarding the applicability of this action to 
a particular entity, consult the person listed under FOR FURTHER 
INFORMATION CONTACT.

B. What Kind of an Experiment is Described in this Notification?

    1. Purpose. These field tests are designed to evaluate the use of 
these new strains of currently registered products in controlling 
mosquitoes. Laboratory evaluations of these new strains suggest that 
they will work much better against the mosquitoes that carry the West 
Nile Virus than the currently used microbial larvaecides. They produce 
a greater amount of the toxin from B. sphaericus (Bsp) and combine its 
effect with the existing B. thuringiensis subsp. israelensis (Bti) 
delta-endotoxins.
    2. Microorganisms. The recombinant strains were constructed using a 
well-characterized standard strain, IPS-82 of Bti (available from the 
Pasture Institute in Paris, France as a reference strain) and a 
currently EPA-registered strain of Bsp, VectoLex produced by Valent 
BioSciences. The recombinant strains were prepared from two versions of 
the IPS-82 strain, one with all the plasmid-borne genes removed except 
those that produce the mosquitocidal proteins that are found in the 
registered Bti products (Cry4A, Cry4B, Cry11A, and CytA delta-endotoxin 
proteins), and another version, with all the plasmid-borne toxin genes 
removed, that does not produce any mosquitocidal proteins.
    The Bsp strain produces a mosquitocidal protein that forms 
characteristic crystals during spore formation much like Bti. The genes 
that produce the Bsp toxin were transferred into the Bti isolates to 
produce the following four combinations of toxins in Bti: Bsp toxin and 
the four Bti delta-endotoxins listed above, Bsp toxin only, Bsp toxin 
and Cyt1A, Bsp toxin and Cry11A plus Cyt1A
    3. Test protocols. The three established mosquito testing 
facilities being used for this test are in California and Florida. The 
Riverside, California, test site uses 3 x 3 feet fiberglass tubs and 
several 12 x 24 feet artificial ponds. The test site at the Coachella 
Valley experiment mosquito testing station in California has 18 x 18 
feet artificial ponds. The test site at a University of Florida 
research center in Apopka, Florida, has 3 feet diameter tubs on a 
cement slab. All test containers use 1 foot or less water depth. The 
treatments will be by hand or using hand-held equipment. Treatment 
(0.007 lbs per) of the modified Bti strains will be applied three times 
for each of the four test strains at each of the two test sites to the 
water containers, for a maximum total of less than 0.03 lbs for the 
Riverside and Florida tubs and less than 4.2 lbs for the Riverside and 
Coachella Valley artificial ponds. Mosquito lavae and pupae will be 
monitored up to 30 days following the treatments. The area will be 
monitored for the presence of the test strains. Tests may be conducted 
up through November 2001.
    4. Containment procedures. The test facilities are in gated 
restricted areas. The water is in contained ponds or containers and 
will be treated with bleach for 24 hours following the experiments. 
Extensive experience with the Bti host cells and the mosquitocidal 
toxins has shown that they degrade rapidly in the environment.

C. How Can I Get Additional Information, Including Copies of this 
Document and Other Related Documents?

    The Agency has established an official record for this action under 
docket control number OPP-00719. The official record consists of the 
documents specifically referenced in this action, any public comments 
received during an applicable comment period, and other information 
related to this action. No information was claimed as confidential 
business information (CBI). This official record includes the documents 
that are physically located in the docket, as well as the documents 
that are referenced in those documents. The public version of the 
official record, which includes printed, paper versions of any 
electronic comments submitted during an applicable comment period, is 
available for inspection in the Public Information and Records 
Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson 
Davis Hwy., Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through 
Friday, excluding legal holidays. The PIRIB telephone number is (703) 
305-5805.

D. How and to Whom Do I Submit Comments?

    You may submit comments through the mail, in person, or 
electronically. To ensure proper receipt by EPA, it is imperative that 
you identify docket control number OPP-00719 in the subject line on the 
first page of your response.
    1. By mail. Submit your comments to: Public Information and Records 
Integrity Branch (PIRIB), Information Resources and Services Division 
(7502C), Office of Pesticide Programs (OPP), Environmental Protection 
Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
    2. In person or by courier. Deliver your comments to: Public 
Information and Records Integrity Branch (PIRIB), Information Resources 
and Services Division (7502C), Office of Pesticide Programs (OPP), 
Environmental Protection Agency, Rm. 119, Crystal Mall #2, 1921 
Jefferson Davis Hwy., Arlington, VA. The PIRIB is open from 8:30 a.m. 
to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB 
telephone number is (703) 305-5805.
    3. Electronically. You may submit your comments electronically by 
e-mail to: opp-docket@epa.gov, or you can submit a computer disk as 
described in this unit. Do not submit any information electronically 
that you consider to be CBI. Avoid the use of special characters and 
any form of encryption. Electronic submissions will be accepted in 
WordPerfect 6.1/8.0 or ASCII file format. All comments in electronic 
form must be identified by docket control number OPP-00719. Electronic 
comments may also be filed online at many Federal Depository Libraries.

E. How Should I Handle CBI that I Want to Submit to the Agency?

    Do not submit any information electronically that you consider to 
be CBI. You may claim information that you submit to EPA in response to 
this document as CBI by marking any part or all of that information as 
CBI. Information so marked will not be disclosed except in accordance 
with procedures set forth in 40 CFR part 2. In addition to one complete 
version of the comment that includes any

[[Page 30460]]

information claimed as CBI, a copy of the comment that does not contain 
the information claimed as CBI must be submitted for inclusion in the 
public version of the official record. Information not marked 
confidential will be included in the public version of the official 
record without prior notice. If you have any questions about CBI or the 
procedures for claiming CBI, please consult the person identified under 
FOR FURTHER INFORMATION CONTACT.

F. What Should I Consider as I Prepare My Comments for EPA?

You may find the following suggestions helpful for preparing your 
comments:

    1. Explain your views as clearly as possible.
    2. Describe any assumptions that you used.
    3. Provide copies of any technical information and/or data you used 
that support your views.
    4. If you estimate potential burden or costs, explain how you 
arrived at the estimate that you provide.
    5. Provide specific examples to illustrate your concerns.
    6. Make sure to submit your comments by the deadline in this 
notice.
    7. To ensure proper receipt by EPA, be sure to identify the docket 
control number assigned to this action in the subject line on the first 
page of your response. You may also provide the name, date, and Federal 
Register citation.

II. What Action is the Agency Taking?

    The Agency will be reviewing this notification in accordance with 
40 CFR part 172, subpart C to determine whether to approve or deny the 
field test, or to required the test to be conducted under an 
Experimental Use Permit.

List of Subjects

    Environmental protection, Genetic engineering, Microbial 
pesticides, small-scale field testing, mosquito control, Bacillus 
thuringiensis.

    Dated: May 25,2001.

Janet L. Andersen,
Director, Biopesticides and Pollution Prevention Division, Office of 
Pesticide Programs
FR Doc. 01-13951 Filed 6-5-01; 8:45 a.m.]
BILLING CODE 6560--50-S
Receipt of a Notification to Conduct Small-Scale Field Testing of a Genetically-Engineered Microbial Pesticide; Notice of Availability

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