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 Government
Documents
There are a variety of Government
Regulations and Guidelines that are of interest to Biosafety mavens
but few others. Some of these can be obtained from Web sites, others
are more difficult to find.
CDC, NIH, Massachusetts,
EPA, OSHA, FDA,
Boston, Cambridge
CDC "BMBL"
The "gold standard" of Biosafety guidance is a
US Centers for Disease Control and Prevention (CDC) publication
called "Biosafety in Microbiological and Biomedical Laboratories"
(BMBL). Its fourth edition can be found at this web site: http://www.cdc.gov/od/ohs/biosfty/bmbl4/bmbl4toc.htm
CDC Biosafety Cabinet (Tissue Culture Hood) Recommendations
CDC Etiologic Agent Import Permit Program
- Pathogen import requires permits. The CDC permits are on the
web.
- An explanation of the Import program at this Link.
- Blank
or fillable
PDF application forms can be down loaded from the CDC.
NIH Recombinant DNA Guidelines:
- Back in the 1970's, when scientists (and the public) were worried
about the personal and environmental risks of working with recombinant
DNA the National Institutes of Health convened a group of experts
to generate a set of guidelines to help the scientific
community. In Boston the Guidelines were enacted into law (not
the NIH's intention). The latest, April 2002, html version can
be found at this web site: http://www4.od.nih.gov/oba/rac/guidelines_02/NIH_Guidelines_Apr_02.htm
- The most recent guidelines can be downloaded as a PDF Document: NIH
Guidelines April 2002.
- The original, 1976,
NIH Recombinant DNA Guidelines
- For many, primarily historical, reasons the NIH Guidelines
are almost impossible to follow or understand. A short summary
of the guidelines can be found at: Guidelines
Explained
- A 1979 companion document, long out of print, called the
"Laboratory Safety Monograph, A Supplement to the
NIH Guidelines for Recombinant DNA Research" was
written by a group of people at the National Cancer Institute.
Scanned verisons are available thus: In
Word, In
WordPerfect, In
Acrobat (PDF).
NIH NSABB - The National
Scientific Advisory Board for Biosecurity
- This is large comittee meets quarterly to discuss how to deal
with innocent research that might aid terrrorists. At present
it is thought evalauation for proposed studies will be the responsibility
of local Institutional Biosafety Committees. Guidance to the IBCs
will come from tee NSABB.
NIH Serious Adverse Event Reporting Requirements
- In 1999 several reported and non-reported serious adverse events
following human trials involving gene transfer stimulated the
NIH and the FDA to strengthen their reporting requirements. The
FDA sent a general letter to all human gene transfer investigators
reminding them of their duty: FDA
5 November 1999 Letter or in PDF
Format
. The NIH developed a reporting form to help investigators report
serious adverse events: Here is the form in rtf format: NIH-CDC/Serious
Adverse Event reporting Form.
NIH New Technology Oversight Reorganization
- Human Gene Therapy, Gene Testing, and Xenotransplantation will
be evaluated through a new Office: The Office of Biotechnology
Assessment (OBA). This new office will include the former Office
of Recombinant DNA Activities. OBA Web site: http://www.nih.gov/od/oba/
NIH Policies on the use of Human Embryonic Stem Cells
- In December 1999 the NIH decided to meet the question of research
using human embryonic stem cells in NIH supported studies head
on. Their proposed solution was somewhat Solomonic. It would be
OK to use stem cells derived from discarded fertilized eggs intended
for in vitro fertilization but never used. Investigators
had to show that the fertilized eggs were not produced for experimentation
- only for fertilization. Fetal tissue from abortions could not
be used to generate stem cells. The "parents" had to
sign an informed consent form. A new office at the NIH was to
be established to check that the rules were being followed. The
proposed regulation can be found from
this hyperlink. A PDF version can be down loaded from this
hyperlink.
Massachusetts Medical Waste Regulations:
- Due to bitter experience most states have legal requirements
for how to deal with "Medical Waste." While the concept
of Medical Waste seems obvious some aspects of the Massachusetts
law are not intuitive. For instance, unused Pasteur pipettes must
be discarded as medical waste although they are clearly non-medical.
The regulation can be seen at Massachusetts
Medical Waste Regulations
Massachusetts Proposed "Needle Stick" Law.
- Several states, including Massachusetts, are trying to combat
the increasing number of needle sticks in clinical and laboratory
settings by requiring hospitals and research institutions to use
hypodermic needles engineered to protect the staff from accidental
sticks. In Massachusetts an early step in this process is a law
proposed by Representative Christine E. Canavan of Brockton.
The text of the proposal is at this hyperlink.
EPA Certified Disinfectants
- Over the years the EPA has examined claims by the manufacturers
of hundreds of disinfectants for their ability to kill selected
pathogens (general sterilants, tuberculosis, HIV, Hepatitis B). These
are given in four lists very useful despite the fact they are
slowly going out of date. The lists are:
OSHA Blood Borne Pathogen Standard
- In 1991, at the height of the concern (some say panic) over
HIV, the US Occupational Health and Safety Administration (OSHA)
established a "Standard" to protect medical and research
employees from infection by HIV and other pathogens found in blood.
OSHA Standards have the force of law and must be obeyed by all
employers. One stipulation of the standard is that employees have
easy access to the written standard itself. The text of the standard
is at OSHA Blood Borne
Pathogen Standard
- As a result of legislation in March 2000 OSHA has issued a revision
of the Bloodborne Pathogen Standard mandating yearly evaluation
of needle devices by labs and hospitals. If needleless devices
can be substituted they should replace current devices. In addition
employers will have to keep a log of needle related injuries whether
they result in illness or not. OSHA maintains a web page related
to the new rules at: http://www.osha-slc.gov/needlesticks/index.html
Food and Drug Administration
- The FDA has a great many documents designed to explain how they
go about approving drugs and medical procedures.
- Biologicals are examined by the FDA Center for Biologics
Evaluation and Research (CBER - pronounced C-BRRR).
- Their web site is at http://www.fda.gov/cber/index.html.
A great many guidance documents are available at this site.
Documents called "Points to Consider" and "Guidelines"
are of particular relevance to those trying to get a new product
through the FDA approval process.
- An example of a useful document from CBER is "Guidance
for Human Somatic Cell Therapy and Gene Therapy" which,
as with most other documents found at the CBER site, is in
PDF format: FDA
Guidelines for Somatic, Gene Therapy
- In November 1999 the FDA sent a letter to all Gene Therapy
PIs reminding them that all Investigational New Drug (IND)
applications will be reviewed by the NIH. In addition notification
of all adverse events related to the trial must be reported
to both the FDA and NIH. A copy of the letter can be found
at this hyperlink: FDA
5 November 1999 Letter (
).
City of Boston Regulations
City of Cambridge Regulations
- Cambridge has written a set of regulations to govern the use
of recombinant DNA. Here
they are
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