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NCI-FREDERICK

INSTITUTIONAL BIOSAFETY COMMITTEE

# Minutes -- Meeting September 16, 2003

NCI-Frederick

The NCI-Frederick Institutional Biosafety Committee was convened at
12:09 p.m. in the Building 549 Board Room with the following members in
attendance:

#  Dr. Randall Morin, Chair Dr. David Garfinkel

Mr. Joseph Kozlovac, Secretary Dr. Henry Hearn

Dr. Bruce Crise Ms. Carol Ingraham Tobias Dr. Stephen Creekmore Dr.
Melinda Hollingshead

###### Dr. Donald Court Dr. Jeanne Herring

###### Ms. Cheryl Parrott (Ex Officio) Dr. Steve Hughes

#####  

##### 

##### Members not in attendance: Dr. Michael Baseler, Mr. Lucien Winegar 

Others in attendance: Ms. Cara Lamberson, Mr. Tom Danvers, Dr. Heather
Lyons

## 

## **INTRODUCTION**

Dr. Morin called the meeting to order.

Dr. Herring introduced Dr. Heather Lyons the new animal program
veterinarian to the committee.

Mr. Kozlovac informed the committee that Dr. Barbara Johnson and
colleagues from SAIC's Center for Biosecurity Strategy was hired to
review the NCI-Frederick's Biosecurity plan required by the USDA and CDC
regulations on select agents and high consequence animal and plant
agents and toxins. Mr. Kozlovac also stated that as part of the review
Dr. Johnson performed a site assessment focusing on areas where
regulated biological agents were used in the recent past or were
currently held. Mr. Kozlovac stated that based upon his impression the
audit went well and that Dr. Johnson's report could be expected soon.

**[REVIEW OF PROTOCOLS]{.underline}**

Dr. Hollingshead and Dr. Herring introduced a recombinant DNA
registration entitled, *Role of TNF and LT in immune responses*
submitted by Dr. Sergei Nedospasov. The committee thought that the
proposed work was not defined enough. Dr. Nedospasov stated that
initially he will be expressing GFP and beta-Gal however he also
indicated that in the future that his lab may express a number of
cytokines that he listed on the registration. Dr. Hollingshead stated
that it was unclear of what the PI wished from the IBC. Did Dr.
Nedospasov at present only want approval for the GFP and beta-Gal
systems and would in the future amend the registration to add the
cytokines of interest or did he want broad approval from the IBC without
providing the necessary information for review of the proposed cytokine
expression work such as the source of the plasmids , viral sequences on
the expression vectors and maps. Dr. Morin indicated that the highest
risk procedure was performing the animal injections. He wanted to know
if the individuals that would be performing these tasks have been
adequately trained and was made aware of potential exposure risks.
General discussion ensued. Mr. Kozlovac suggested that the committee
grant Dr. Nedospasov conditional approval so that work with the
commercially available GFP and beta-Gal systems and require that the
registration be amended when Dr. Nedospasov is ready to work with the
proposed cytokines and chemokines.

Conditionally Approved

1.  Provide procedure specific training information/documentation for
    individuals that will be performing the animal injections.

2.  Amend recombinant DNA registration and receive approval prior to
    initiating work with systems other than the commercially available
    GFP and beta-Gal systems.

3.  Provide maps and detailed information for non-commercial cytokines
    and chemokines. If this information is not available utilize the
    services of the Laboratory of Molecular Technology.

Dr. Garfinkel introduced a pathogen registration entitled,
*Recombineering in bacteria other than E. coli K12* submitted by Dr.
Donald Court. Dr. Court would like to be able to work with the
avirulent, noninvasive strain of Salmonella typhimurium LT2, the
avirulent H. influenzae laboratory strain Rd and the Yersinia
pseudotuberculosis strain which lacks the virulence plasmid. The
experiments which are planned include the natural transfer of an F' sex
factor carrying the spectinomycin gene and E. coli galactose operon and
a 5kbp segment of the lambda prophage into these other bacteria.
Discussion ensued.

Approved

Other Business

Dr. Morin reviewed the current renewal approval process with the
committee. Dr. Morin stated that when a protocol was due for renewal the
PI was contacted to submit a renewal registration. Once the form has
been submitted the Biosafety Officer, IBC Coordinator and IBC chair
review the protocol. If the renewal does not have any significant
changes from what was previously approved the renewal is approved and a
letter is sent to the PI. If a change in facility, reagents or scope of
research is indicated in the renewal document it is assigned a lead
reviewer and is sent to full committee prior to approval. Dr. Morin
wanted to ensure that the committee was comfortable with the current
system. The IBC indicated that they were satisfied with the current
renewal review system and trusted the judgement of the IBC chair and EHS
staffers.

Annual update letters to all PI's with registrations was also discussed.
Mr. Kozlovac indicated that this was frequently done in the past with
pathogen registrations however had not been done with rDNA
registrations. Dr. Morin requested that the update form letter be
brought to the next meeting for review.

Meeting Adjourned: 1:24 pm

Respectfully submitted,

Joseph P. Kozlovac, M.S., RBP

Executive Secretary, NCI-Frederick

###  Institutional Biosafety Committee

Approved: \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ Randall S. Morin, Dr.
P.H.

Chairman, NCI-Frederick IBC

xc: Each Committee Member

Dr. Wiltrout

Mr. Defelice

Dr. Reynolds

Mr. Eaton

Dr. Arthur

Mr. Bufter