The Scripps Research Institute Biosafety Committee

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The Scripps Research InstituteBiosafety Committee

• Donald E. Mosier, PhD, MD
• IBC Chair

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TSRI Campus Map
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IBC Membership
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Submission Review Procedures

• All investigators must complete online biosafety
  training prior to acceptance of Microbiological
  Hazard Registration
• Agent specific training must also be completed
• Compliance and test results are recorded at
  website

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Microbiological Hazard Training New!!! Please
note, if you have already completed sections 1
and 2, basic and infectious agent training, you
may go directly to the infectious agents list to
train on individual infectious agents. There is
no quiz associated with individual agents. You
must enter your user ID to get credit for this
section. Welcome to the Microbiological hazard
training site home page. This is TSRI's first
Web-Based Training Program. Our goal is to make
the program convenient - training should
be available 24 hours a day, 7 days a week.
informative - our aim is to provide an overview
of microbiological safety at TSRI, and to provide
sufficient detail to provide a reasonable
foundation These training pages will serve as
your introduction to working safely with
microorganisms. As we stress in several places,
this web-based training complements, but does not
replace, the "hands-on" training necessary to
competently handle potentially pathogenic
materials. Continue training gt After you have
completed this training, you may wish to refresh
your memory about a particular item. Rather than
requiring you to enter at the beginning, and read
all the pages until you reach the information you
need, you can browse the Microbiological Hazard
Reference section. You may reach the browsable
section on the Biosafety Home Page.
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Forms Note All forms are in Adobe Acrobat 4 pdf
format. While these forms are printable in
Acrobat version 3, to be able to fill them out
electronically, you need Adobe Acrobat Reader
version 4. If you want to be able to save the
edited forms, you need the full Adobe Acrobat 4
package. You can download Acrobat Reader 4 from
Adobe, or contact Procurment for information on
the full Acrobat package. It is recommended that
you download the forms before filling out and
printing. If your browser is set up to open pdf
files in the browser, you can download the pdf
files by (on a Windows system) holding down the
Control key, then clicking on the link, or (on a
Macintosh system) holding down the Option key and
clicking on the link. Biosafety Please note
Effective 11/14/01, the TSRI IBC requires that a
vector map must be submitted for all
"non-standard" vectors. Non-standard vectors
include those that are not commercially available
as well as vectors that are commercially
available but not in wide distribution. A vector
map must be provided for any vector that will be
introduced into human cell lines or animals.
Please contact the Biosafety Office at 4-8240 for
further information. Annual Update For
Microbiological Hazard Registration Microbiologica
l Hazard Registration Form Recombinant DNA
Registration Document Addendum To Biosafety
Registration Document Declination Of Immunization
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TSRI Recombinant DNA Registration Form
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TSRI Microbiological Hazard Registration Form (p.
1 of 7)
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Review of recombinant DNA and Microbiological
Hazard Registration Forms
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Investigators and pathogens

• 91/300 investigators are registered to use
  pathogens in their research
• 292 BSL-2 protocols
• 21 BSL-2/3 protocols
• 21 BSL-3 protocols
• 94 pathogenic agents/variants
• 5 toxins
• 13 select agents

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Distribution of Viral Vectors Reviewed
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Select Agents

• Ebola strains (inactivated)
• Ebola glycoprotein
• Hantavirus
• Botulinum toxin
• Yersinia pestis

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BSL-3 Protocols

• Known human pathogens used in novel context
  e.g., HIV-1, hepatitis B, hepatitis C, prions
• Viruses or viral vectors introduced into animals
  (mice) that generate possibility of recombination
  and rescue
• One interesting example follows

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Infection by porcine endogenous retrovirus after
islet xenotransplantation in SCID mice. van der
Laan LJ, Lockey C, Griffeth BC, Frasier FS,
Wilson CA, Onions DE, Hering BJ, Long Z, Otto
E, Torbett BE, Salomon DR. Nature 2000 Sep
7407(6800)90-4 The Scripps Research Institute,
Department of Molecular and Experimental
Medicine, La Jolla, California 92037,
USA. Animal donors such as pigs could provide an
alternative source of organs for transplantation.
However, the promise of xenotransplantation is
offset by the possible public health risk of a
cross-species infection. All pigs contain several
copies of porcine endogenous retroviruses (PERV),
and at least three variants of PERV can infect
human cell lines in vitro in co-culture,
infectivity and pseudotyping experiments. Thus,
if xenotransplantation of pig tissues results in
PERV viral replication, there is a risk of
spreading and adaptation of this retrovirus to
the human host. C-type retroviruses related to
PERV are associated with malignancies of
haematopoietic lineage cells in their natural
hosts. Here we show that pig pancreatic islets
produce PERV and can infect human cells in
culture. After transplantation into NOD/SCID
(non-obese diabetic, severe combined
immunodeficiency) mice, we detect ongoing viral
expression and several tissue compartments become
infected. This is the first evidence that PERV is
transcriptionally active and infectious
cross-species in vivo after transplantation of
pig tissues. These results show that a concern
for PERV infection risk associated with pig islet
xenotransplantation in immunosuppressed human
patients may be justified.
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Interaction between IBC and IACUC

• Any animal protocol involving human or animal
  pathogens is reviewed first by the IBC and then
  the IACUC.
• Since IACUC approval is necessary for NIH grant
  submission but IBC approval is not, this leads to
  some expedited reviews near grant deadlines.

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IBC Challenges

• Depth of local expertise in infectious diseases
  sometimes leads to interesting discussion of CDC
  guidelines
• Required versus highly recommended vaccination
  policies confront difficult medical and legal
  issues
• "Spontaneous" research collaborations

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Contact Information

• For more information, contact dmosier_at_scripps.ed
  u or ckeier_at_scripps.edu or
  www.scripps.edu