A message from Alan I. Leshner, AAAS CEO

[Peter Fairbrother]

Steve Schear wrote:

> At 05:07 PM 9/6/2002 -0400, you wrote:
>> Dear Colleague:
>> 
>> As the anniversary of September 11th approaches, AAAS continues to
>> be engaged in issues that relate to national security and the role of
>> science and technology.  One such issue is the safe and responsible
>> conduct of research involving biological agents and toxins.
>> 
>> AAAS was recently asked by the Centers for Disease Control (CDC) to
>> assist in alerting our members to the federal mandate (Public Law 107-188)
>> requiring all facilities and persons that possess, use, or transfer agents
>> or toxins considered a threat to animals, plants, animal and plant products
>> and/or public health (called "select agents") to notify the CDC and the
>> U.S. Department of Agriculture.  Approximately 200,000 facilities were
>> sent a copy of the notification form by the CDC.
>> 
>> The deadline for submitting a completed form to the CDC is September 10,
>> 2002.  All entities that receive a copy of the form must comply, even if
>> they do not possess a select agent or toxin.  If you are in possession of
>> a select agent or toxin and did not receive a form, you should call CDC's
>> toll-free number: 1-866-567-4232.
> 
> Thanks Alan but,
> 
> This slippery slope concerning the ability of only approved researchers
> able to engage in science has gone too far and has got to stop.  I don't
> accept that the "right of society" to protect itself from a few madmen
> abusers of technology means we all must carry scientist ID cards.  Most of
> the significant discoveries, until this century, were made by
> amateurs.  Almost all the R&D I did in the 60s and 70s as an amateur are
> now regulated.  If I do any research, using whatever chemicals I choose, I
> won't be filing no "stinking forms.
> 
> steve


I think it's actually quite reasonable: below is the proposed new list of
agents with some notes from me in [>  <] (much the same as the old list,
which is presently used to regulate transport, and you already need to be
registered to send/receive these agents), and except for malicious reasons I
can't think why anyone would want to use them outside a fully-equipped lab.
Anyone who does is showing negligent disregard for human/ the public's
safety. And his own.

While there may be an anti-terrorist element to the Public Health Security
and Bioterrorism Preparedness and Response Act (I haven't read it), there's
a safety element too. I don't know if any labs who do things right will be
refused registration/permission, we'll have to see. They may need armed
guards or something. At first sight it doesn't affect researchers much (they
already need approval/licences to work on most of this stuff, it's mostly
changes to regulations about storage).

A curiosity - a 1oz packet (the smallest size available to gardeners) of
castor beans probably contains more than the exempted 100 mg of ricin.
However, it's not a "Toxin preparation", so they won't have to register.
Could kill quite a few people if it was.

-- Peter Fairbrother


List of Select Agents and Toxins
The following is the list of select
agents and toxins that is being
considered for adoption:

Viruses:
1. Crimean-Congo haemorrhagic fever virus
2. Eastern Equine Encephalitis virus
3. Ebola viruses
4. Herpes B virus
5. Lassa fever virus
6. Marburg virus
7. Monkeypox virus
8. Nipah and Hendra Complex viruses
9. Rift Valley fever virus
10. South American Haemorrhagic fever viruses (Junin, Machupo, Sabia,
Flexal, Guanarito)
11. Tick-borne encephalitis complex (flavi) viruses (Central European
Tick-borne encephalitis, Far Eastern Tick-borne encephalitis (Russian Spring
and Summer encephalitis, Kyasanur Forest disease, Omsk Hemorrhagic Fever))
12. Variola major virus (Smallpox virus)
13. Venezuelan Equine Encephalitis virus

Bacteria:
1. Bacillus anthracis
2. Brucella abortus
3. Brucella melitensis
4. Brucella suis
5. Burkholderia mallei
6. Burkholderia pseudomallei
7. Botulinum neurotoxin producing strains of Clostridium
8. Coxiella burnetii
9. Francisella tularensis
10. Rickettsia prowazekii
11. Rickettsia rickettsii
12. Yersinia pestis

Fungi:
1. Coccidioides immitis
2. Coccidioides posadasii


[> Most (all?) of the above infectious agents shouldn't be handled outside
Biosafety Level 3 or 4 labs (for live cultures or potential aerosols).
Dangerous stuff. BSL3/BSL4 labs already need approval, and all facilities
already need to be registered to receive or send this kind of material
anyway. This new proposal now requires notification of possession/storage
too - not a big change. <]


Toxins:
1. Abrin
2. Botulinum neurotoxins
3. Clostridium perfringens epsilon toxin
4. Conotoxins
5. Diacetoxyscirpenol
6. Ricin
7. Saxitoxin
8. Shigatoxin and Shiga-like toxins
9. Staphylococcal enterotoxins
10. Tetrodotoxin
11. T-2 toxin
Exemptions: Toxin preparations containing 1 mg of Botulinum neurotoxins;
10 mg of Staphylococcal enterotoxins; or 100 mg of Abrin, Clostridium
perfringens epsilon toxin, Conotoxins, Diacetoxyscirpenol, Ricin, Saxitoxin,
Shigatoxin and Shiga-like toxins, Tetrodotoxin, or T-2 toxin, are exempt.
Toxin preparation stored in more than one location within a facility must be
aggregated in determining if the exemption applies. The medical use of
toxins for patient treatment are exempt.


[> The exempted quantities of listed toxins are enough to do some reasonable
research (the exempted amounts of some of the listed toxins are enough to
kill 1000+ people, though not in any likely situation). It might affect some
researchers though. <]


Genetic Elements, Recombinant Nucleic Acids, and Recombinant Organisms:
1. Full length nucleic acids (synthetic or naturally derived) of any of the
viruses listed in Appendix A.
2. Nucleic acids (synthetic or naturally derived) of 100 nucleotides or more
in length of Variola major virus (smallpox virus).
3. Nucleic acids (synthetic or naturally derived) of bacteria, fungi, or
viruses listed in Appendix A that encode for either a functional toxin or
virulence factor sufficient to cause disease if the nucleic acid is: (1)
Expressed in vivo or in vitro; (2) in an expression vector or host
chromosome; or (3) in a carrier plasmid.
4. Nucleic acids (synthetic or naturally derived) that encode for functional
form of any of the toxins listed in Appendix A if: (1) Expressed in vivo or
in vitro; (2) in an expression vector or host chromosome; or (3) in a
carrier plasmid.
5. Microorganisms in Appendix A that have been genetically modified.


[> I don't want any recombinant DNA at all out in the environment, myself.
P4 the lot! (P4 is a WHO standard for labs, to protect the public against
the release of new organisms into the environment, eg germ warfare labs,
recombinant DNA labs, or the labs used by the Apollo astronauts to protect
against possible diseases from space, whereas BSL3/BSL4 are US standards
aimed more at protecting lab staff from diseases that are already in the
environment, eg anthrax, botulism, etc., though they also try to protect
against accidental releases.) <]

[> Without getting into the wider argument of releasing new organisms made
by genetic modification, the list seems fairly sensible. 2) is badly written
and might cause some grief, as some Variola major 100-nucleotide lengths of
R/DNA are undoubtedly identical to lengths that exist in other, harmless,
organisms. Politics again. >]

[> Then again, IMO the conditions in 3) and 4) aren't stringent enough. And
5) should be banned completely, but the germ warfare people wouldn't like
that. <]


Other Restrictions:
The deliberate transfer of a drug resistance trait to microorganisms listed
in this Appendix that are not known to acquire the trait naturally is
currently prohibited if such acquisition could compromise the use of the
drug to control these disease agents in humans or veterinary medicine.


[> And this is extremely sensible. <]