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###### Environmental Protection Agency

          - [OPP-00719; FRL-6783-2]

# AGENCY:

Environmental Protection Agency (EPA).

# ACTION:

Notice.

# 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                               ( print 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                           ( print 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, 

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.]

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