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NCI-FREDERICK

INSTITUTIONAL BIOSAFETY COMMITTEE

# Minutes -- Meeting April 20, 2004

NCI-Frederick

The NCI-Frederick Institutional Biosafety Committee was convened at
12:05 p.m. in the Building 549 Executive Boardroom with the following
members in attendance:

#  

Mr. Joseph Kozlovac, Secretary Dr. Stephen Creekmore

Dr. Bruce Crise Dr. Michael Baseler

######  Dr. Steve Hughes Dr. Donald Court

> Dr. Jeanne Herring Ms. Carol Ingraham Tobias
>
> Ms. Cheryl Parrott (Ex Officio) Mr. Lucien Winegar, Esq

#####  

Members not in attendance: Dr. Randall Morin, Dr. Melinda Hollingshead,
Dr. Henry Hearn, and Dr. David Garfinkel

Others in attendance: Ms. Cara Lamberson, Mr. Tom Danver, Dr. Laura
Schmidt and Dr. Masaya Baba

## 

## **INTRODUCTION**

Mr Kozlovac called the meeting to order. Mr. Kozlovac gave the committee
a brief summary of the public meeting he attended on April 12, 2004,
regarding the addition of a chapter on biosecurity to the next revision
of the CDC/NIH publication Biosafety in Microbiological and Biomedical
Laboratories. Mr. Kozlovac informed the committee that a variety of
groups including The Sunshine Project provided comments. Mr. Kozlovac
informed the committee that the Sunshine Project's comments referenced
their recent survey of IBCs. Ms. Parrott asked if this IBC responded to
the request for information and Mr. Kozlovac responded that the
NCI-Frederick provided copies of the IBC minutes per Section
IV-B-2-a-(7) of the NIH Recombinant DNA Guidelines.

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

Mr. Kozlovac introduced a recombinant DNA registration submitted by Dr.
Laura Schmidt entitled, *Establishment of stable folliculin-expressing
human renal tumor cell line and biochemical analysis*. Mr. Kozlovac
informed the committee that this protocol would utilize the Invitrogen
ViraPower Lentiviral Expression System, which has been reviewed by the
committee previously, to generate lentivirus stock expressing folliculin
mutants of interest and transduce and select stable clones in well
characterized cell lines. Mr. Kozlovac introduced Dr. Schmidt to further
explain the experiment. Dr. Schmidt indicated that Dr. Wiltrout's Lab,
which was to be used for the production of concentrated stocks, would
not be utilized and all work would be conducted in lab 12-25. Dr. Hughes
expressed his dissatisfaction that the manufacturer continued to provide
information on the safety of this lentiviral expression system that is
misleading.  This vector, which the IBC has reviewed and approved in the
past, is safe due to a deletion  in the env gene, and not because the
viral genes are expressed from separate plasmids.  Separating the
genetic information onto multiple plasmids does decrease the risk of
recombination however recombination has been shown to occur with this
type of retroviral expression system.  Dr. Hughes is concerned that
individuals who are not well versed in virology and are using these
vector systems could be mislead. It is a disservice for the manufacturer
to lead users to believe that retroviral vectors will not recombine,
giving rise to replication competent viruses, if the viral genes are
expressed from separate plasmids. Dr. Crise asked Dr. Schmidt if the lab
intended to use sharps in the lab since needles are mentioned in the SOP
in section B.8. a-d. Dr. Schmidt informed the committee that the lab is
not intending to use needles and that the language was taken directly
out of the CDC/NIH BMBL 4^th^ edition from BSL-2 special practices
section. Dr. Creekmore asked Dr. Schmidt if any animal work was planned
in conjunction with this experiment. Dr. Schmidt informed the committee
that no animal work was being considered as part of this experiment at
this time.

**APPROVED**

Dr. Court introduced a new pathogen registration submitted by Dr. Ronald
Hornung entitled, *Herpes Simplex Cytokine Polymorphism Protocol*. Dr.
Court briefly discussed the study's purpose, which is to determine if
HSV infected persons that have symptoms have differences in their
cytokine genes as compared to infected persons that do not exhibit
symptoms and individuals that have never been infected with HSV. The
main hazard in the laboratory will be the manipulation of human blood
samples. Mr. Kozlovac stated that the laboratory is a BSL-2 facility
utilizing BSL-3 practices, which was more than adequate for the proposed
work.

**APPROVED**

Dr. Creekmore introduced a new pathogen registration submitted by Dr.
Patricia Fiero entitled, *Tobacco Intervention Research Clinic*. This
work involves the analysis of various patient samples such as blood and
other potentially infectious materials. Dr. Creekmore stated that the
employees working with this material would have the same level of risk
that other clinical laboratory researchers have when working with
unscreened patient isolates. Mr. Kozlovac informed the committee that
there had been some debate as to whether the NCI-Frederick IBC should
review this work since it is being conducted in Rockville, however as a
result of discussions with Beth Baseler, Dr. Morin, Mr. Danver and
himself it was determined that the NCI-Frederick IBC would be an
appropriate review body since the facility is managed and staffed by
SAIC-Frederick employees. The protocol had previously obtained
Institutional Review Board (IRB) approval from the NCI. Mr. Kozlovac
stated that he has not visited the clinic. Ms. Tobias stated that she
had visited the lab and thought that it was appropriate for low risk
blood manipulations. Mr. Winnegar said that he did not see on the IRB
packet whether the protocol had been approved. Some of the members
pointed out that the IRB had been signed by the IRB chair in the
approvals section and had been assigned a protocol number. Dr. Baseler
expressed to the committee that he believed that it was not necessary
for the IBC to know if the IRB has approved the protocol regarding to
treating patients since he believed the IBC's role is to evaluate the
safety and environmental impact aspects of the research.

**APPROVED**

Dr. Crise introduced an amendment submitted by Dr. Jinhua Lu to add
additional laboratories to pathogen registrations P190701JLA01 and
P180303JLA01, which deal with the culture and manipulation of various
adenoviral vectors. Dr. Hughes said that ideally the existing people
that are on the current registration and understand the associated risks
of working with adenovirus would be the only ones that had access to the
lab especially during any large scale work. Mr. Kozlovac stated that a
few of these rooms had only recently been turned over to BDP and were
scheduled for minor renovation which was going to happen prior to any
active work taking place in those labs. The IBC felt that when
adenovirus work was being conducted in the lab that access should be
limited to only individuals that are on the registration. The PI needs
to arrange for an EHS inspection of the labs, which are undergoing
renovation prior to conducting active work with adenovirus.

**CONDITIONALLY APPROVED**

**Renewal of P160192DKA03 and P16019DKB03**

Dr. Hughes did not believe that these pathogen renewal registrations
submitted by Dr. Douglas Kuhns both entitled, *Neutrophil Monitoring
Laboratory* and involving work with HIV and EBV respectively did not
require full committee review. Although Dr. Hughes did not believe there
are no safety issues with this particular lab, he is uncomfortable with
multiple infectious agents and human samples within the same lab space.
In cases such as this the individuals working in the lab need to work
with good care.

**Renewal of P020799WKA01**

Dr. Creekmore reviewed a renewal registration submitted by Dr. Mark
Cosentino entitled, *Processing of blood samples for NSABP, SELECT, PLCO
and PCPT*. Mr. Winegar asked if registration renewals are compared
against the registration document on file to determine if changes have
been made. Mr. Kozlovac explained that when a registration comes into
EHS that it is compared to the documentation that EHS has on file to
determine if there are any significant changes. Dr. Court asked if it
would be possible for EHS to provide what other registered work is being
conducted in a particular laboratory when the IBC receives a new
registration or a renewal registration for review. Mr. Kozlovac stated
that he felt that was a good idea and EHS would provide that information
to the committee members.

**Renewal of P120496BZA02**

Dr. Baseler reviewed a renewal registration submitted by Dr. Berton Zbar
entitled, *Identification of Genes in Inherited Kidney Cancer*. Dr.
Baseler had only one issue with this renewal registration in that within
the overview submitted by Dr. Zbar is that it is stated, "All other SOPs
as presented on the EHS website are followed". Ms. Lamberson informed
the committee that the lack of an SOP was noted during EHS's initial
review and that Dr. Laura Schmidt who is listed as the supervisor of
this project did provide an SOP to EHS after she had sent the review
packets to the committee members.

**Renewal of P310101MBB01**

A renewal registration submitted by Dr. Tomozumi Imamichi entitled,
*Laboratory of Human Retrovirology*, was reviewed by Ms. Tobias prior to
the meeting. Ms. Tobias did not believe that this renewal needed full
committee review and provided her comments to the IBC administrator via
email.

**Renewal of P300101WKA01 and P170394WKA03**

Dr. Herring reviewed two renewal registrations submitted by Dr. William
Kopp both entitled, *Clinical Support Laboratory*, prior to the meeting.
Dr. Herring did not believe that this renewal needed full committee
review and provided her comments to the IBC administrator via email.

**Renewal of P181200MBA01 and P061196MBA02**

Dr. Garfinkel reviewed two renewal registrations submitted by Dr. Ligia
Pinto both entitled, *HPV Immunology Laboratory*, prior to the meeting.
Dr. Garfinkel did not believe that this renewal needed full committee
review and provided his comments to the IBC administrator via email.

**OLD BUSINESS**

Dr. Crise informed the committee that the amendments to registrations
P190701JLA01 and P180303JLA01submitted Dr. Jinhua Lu and conditionally
approved at the last meeting pending submission of additional
information by the PI could be approved. Dr. Lu adequately addressed the
concerns of the IBC in his revised submission.

Mr. Kozlovac and Ms. Lamberson provided an update on the rDNA
registration submitted by Dr. Wakefield which was discussed at the last
meeting with approval pending the PI making IBC suggested changes to the
registration and submitting additional information. The committee felt
that the additional information submitted by the PI was adequate however
the IBC requested that an attendance sheet from the EHS discussion of
safety issues with the animal technicians and animal care folks be
placed into the registration documentation once the session had been
held.

**OTHER BUSINESS**

Ms. Tobias briefly followed up regarding HCV vaccine clinical trials.
Ms. Tobias also informed the committee that she would schedule to have
OHS deliver an overview of the HIV surveillance program at an upcoming
meeting.

Mr. Winegar commented on the minutes from the last meeting, which he
thought reflected very well on this committee. He stated that very often
oversight committees are often criticized as granting rubber stamp
approval, however due to the detailed minutes which show the thoughtful
discussion of the members that no one could criticize this IBC as being
a rubberstamp committee and that this was especially important due to
the current scrutiny that IBC were under from various public interest
groups such as the Sunshine Project.

Meeting Adjourned: 1:20 pm

Respectfully submitted,

Joseph P. Kozlovac, M.S., CBSP, 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

Dr. Reynolds

Mr. Eaton

Dr. Arthur

Mr. Bufter