Memorandum by the Science and Technology
Section, British Embassy, Washington DC
1. The US is leading the world in the field
of human genomics. This paper summarises the current activity
in genetic databases, who is doing what in the US and why, the
main focus of the current House of Lords Inquiry. This is only
a very small part of total US activity in the field of human genomics.
Department of Defense DNA Specimen Repository
for Human Remains Identification
2. The Department of Defense (DOD) DNA Specimen
Repository is the world's largest DNA databank. Since June 1992,
the DOD has required all military personnel to provide blood and
saliva samples for its DNA Specimen Repository at the time of
enlistment, re-enlistment, annual physical or preparation for
operational deployment. The Repository also contains samples from
civilians and foreign nationals who work for the US military in
arenas of conflict. The purpose of the DNA Registry is to identify
the remains of soldiers killed in combat or missing in action.
The military's policy ensures that specimens can be used only
for remains identification and routine quality control, except
when subpoenaed following an investigation or prosecution of a
crime. The specimens cannot be used without consent for any other
purpose such as paternity suits or genetic testing. The specimens
are considered confidential medical information and military regulations
exist to cover any privacy concerns.
Forensic DNA Banks
3. In 1989, the Virginia Division of Forensic
Science became the first US state to pass laws that required certain
classes of offenders to submit DNA samples for inclusion in a
DNA databank. This law requires certain sex offenders and certain
violent felons to provide samples for the state DNA databank.
Presently it is estimated that Virginia authorities receive more
than 20,000 DNA samples a year, which are added to the more than
150,000 samples that have been collected and stored since 1989.
Following Virginia's example, the other 49 states have subsequently
passed laws requiring the collection of DNA samples from certain
criminals. All 50 states require DNA samples from convicted sex
offenders, with some states collecting from all classes of felons.
It is estimated that nationwide samples from about 400,000 offenders
have so far been collected.
4. Through the DNA Identification Act of
1994, a national oversight committee was established to develop
guidelines for DNA forensics and a five year $14 million grant
programme was put in place to assist the state and local laboratories
in developing and improving their forensic DNA testing capabilities.
The DNA Identification Act also formally authorised the FBI to
establish the Combined DNA Index System (CODIS) for law enforcement
5. These databanks have caused controversy
however, and in 1997 the Attorney General directed the National
Institute of Justice to establish and administer a commission
on the future of DNA evidence, the purpose of which is to provide
the Attorney General with advice on the use of current and future
DNA methods in the operation of the criminal justice system. The
Commission has already released reports on the use of DNA in post-conviction
cases and the criteria for training and technical assistance for
criminal justice professionals involved in the identification,
collection and preservation of DNA evidence at the crime scene.
The Commission is currently looking at the impact of future technological
developments on the use of DNA in the criminal justice system.
National Institutes of Health (NIH)
6. A number of the Institutes at NIH have
supported the establishment of DNA databanks to support their
missions. The National Cancer Institute (NCI) has led in the establishment
of such databases, the biggest of which is the NCI Breast Cancer
Specimen and Data Information System which includes DNA from patients
diagnosed with breast cancer, those at risk and unaffected individuals.
The NCI is now working closely with the National Human Genome
Research Institute on databases for colorectal and gynaecologic
7. The National Institute of Allergy and
Infectious Diseases, the National Heart Lung and Blood Institute,
the National Institute of Mental Health and the National Institute
of Ageing have also established tissue banks which include DNA
libraries and DNA clones.
8. Until recently, the Rare Diseases Community
led US private sector activity. For example, work has been done
for Huntington's disease, MS and PXE.
9. A number of small biotechnology companies
are now moving into the genetic databases area. Many of these
companies are in the growing area of pharmacogenomics. This is
a fast-moving and highly-competitive sector, with a number of
companies competing to provide services to the large pharmaceutical
and biotechnology companies through the provision of new therapeutic
candidates and/or through helping with clinical trials thus shortening
time to market. The US Companies most active in this area are
Incyte Genomics, Affymetrix, Double Twist, and DNA Dynamics (based
in California), Genaissance (based in Boston) and Gene Logic,
Celera and Human Genome Sciences (based in Maryland).
10. One company of particular interest is
Myriad, based in Salt Lake City, Utah. The Utah population is
fairly unique in that early settlers had very large families (12
or more children). These settlers therefore left thousands of
descendants. Myriad has arranged exclusive access to three vast
genetic databases on these families. Using these extensive family
genealogy databases and DNA specimens Myriad is developing more
targeted, effective diagnostics and therapeutics.
11. Privacy and confidentiality of genetic
information and fairness in the use of such information, in particular
by insurers and employers, are the main concerns in the US. A
number of bills have been introduced at the State and Federal
level to establish limitations on the disclosure and use of genetic
information but to date none have been passed. Although no specific
federal genetic non-discrimination legislation has been enacted
the Americans with Disabilities Act of 1990 (ADA) provides some
protections against disability-related genetic discrimination
in the workplace. But it does not protect against discrimination
based on unexpressed genetic conditions or protect potential workers
from requirements or requests to provide genetic information to
12. But on 8 February 2000, President Clinton
signed an executive order prohibiting every federal department
and agency from using genetic information in any hiring or promotion
action. This executive order, endorsed by the American Medical
Association, the American College of Medical Genetics, the National
Society of Genetic Counsellors, and the Genetic Alliance, prohibits
federal employers from requiring or requesting genetic tests as
a condition of being hired or receiving benefits and provides
strong privacy protections to any genetic information used for
medical treatment and research.