Policing Bioterror Research

[Eugen Leitl]

http://sciencenow.sciencemag.org/cgi/content/full/2002/1217/1

Policing Bioterror Research

One of science's hottest fields is now becoming one of its most heavily 
regulated, too. The U.S. government last week unveiled sweeping new 
bioterror research regulations that will require 20,000 scientists at 
nearly 1000 laboratories to beef up security--or face hefty fines and jail 
sentences. The interim rules, due to go into effect early next year, could 
also force scientists to get prior approval for a growing list of 
sensitive experiments.

Select experts. CDC's Larry Sparks (right) and other government officials 
answer questions about the new rules.
CREDIT: D. MALAKOFF/SCIENCE

The 13 December announcements in the Federal Register, which ran nearly 50 
pages, are a response to the 2001 anthrax letter attacks. Alarmed by 
reports of weak security in labs that study deadly viruses, bacteria, and 
other potential bioweapons, Congress this summer passed a bioterror bill 
that called for stricter controls on dozens of "select agents" that could 
imperil people, farm animals, and crops (Science, 31 May, p. 1585).

The new rules, issued by the Centers for Disease Control and Prevention 
(CDC) in Atlanta, in conjunction with the U.S. Department of Agriculture 
(USDA), mete out responsibilities among universities, private companies, 
and government laboratories. All must agree to unannounced inspections. 
Labs that handle any of nearly 100 select agents must register with the 
government, submit detailed physical security and training plans, and 
provide the names--and probably fingerprints--of all workers for 
background checks. Moreover, prior approval from the Department of Health 
and Human Services will be needed for experiments that might make a select 
agent more toxic or more resistant to known drugs, as well as similar 
studies that could be added to a restricted list.

Some researchers think the list is a good idea. Biochemist Richard Ebright 
of Rutgers University in Piscataway, New Jersey, says it should include 
experiments that could lead to better methods for making or spreading 
bioweapons. "It's common sense that such work get stricter scrutiny," he 
says.

But Ron Atlas, a bioterrorism expert at the University of Louisville in 
Kentucky and president of the American Society for Microbiology, says he's 
"not sure the government should start proscribing experiments . and 
locking rules into regulations" which can be difficult to adjust, he says. 
He'd rather have the government issue less legalistic guidelines, which 
better evolve with the times.

--DAVID MALAKOFF

Related sites
CDC and USDA rules http://www.asm.org/
CDC select agent FAQ http://www.cdc.gov/od/sap/docs/faq.pdf

FAQ for New Select Agent Regulation (42 CFR 73)
General Questions Concerning Select Biological and Toxins
1. What is the Public Health Security and Bioterrorism Preparedness and 
Response Act of 2002
and how do I find a copy?
On June 12, 2002, President Bush signed the .Public Health Security and 
Bioterrorism
Preparedness Response Act of 2002. (Public Law 107-188). The law is 
designed to improve the
ability of the United States to prevent, prepare for, and respond to 
bioterrorism and other public
health emergencies. Section 202(a) of the Law requires that all persons 
possessing biological
agents or toxins deemed a threat to public health to notify the Secretary, 
Department of Health
and Human Services (HHS). Section 213(b) of Law requires all persons 
possessing biological
agents or toxins deemed a threat to animal or plant health and to animal 
or plant products notify
the Secretary, United States Department of Agriculture (USDA).
The Law also requires that both Secretaries be notified when a person 
possesses agents that
appear on both the HHS and the USDA list of agents and toxins. These 
agents and toxins have
been designated HHS/USDA overlap agents.
The Centers for Disease Control and Prevention (CDC) has been designated 
as the HHS agency
responsible for providing guidance on this notification. The Animal and 
Plant Health Inspection
Service (APHIS) has been designated as the USDA agency responsible for 
providing guidance
on this notification.
For more information on the Public Health Security and Bioterrorism 
Preparedness and
Response Act of 2002 (Public Law 107-188) see: 
http://www.cdc.gov/od/sap/bioterro.htm
Subsequent to the enactment of Public Law 107-188, requirements for 
facilities or entities that
possess, use, or transfer select agents and toxins have been published by 
HHS (42 CFR 73;
December 13, 2002) and by USDA (9 CFR 121 and 7 CFR 331; December 13, 
2002).
2. What is the USA PATRIOT Act and how does it relate to the new select 
agent regulation?
Where can I find a copy?
The USA PATRIOT Act is a law signed by President Bush on October 26, 2001, 
that places
restrictions on persons who possess select agents and provides criminal 
penalties for possession
of such agents that cannot be justified for specified peaceful purposes. 
More information on the
PATRIOT Act can be found at: http://www.cdc.gov/od/sap/patriot.htm
3. What is a select agent or toxin (.select agent.)? What is a High 
Consequence Pathogen and
Toxin? How do they differ?
The original list of select agents was published in Appendix A of 42 CFR 
Part 72.6 (.Additional
Requirements for Facilities Transferring or Receiving Select Agents,. 
October 24, 1996). The
list included approximately 40 viruses, bacteria, rickettsiae, fungi, and 
toxins that CDC considers
New Select Agent Regulation FAQ Page 1 of 13
to have potential to pose substantial harm to human health. The list of 
select agents in 42 CFR
72.6 is available at: http://www.cdc.gov/od/sap/42cfr72.htm. Under that 
regulation, laboratories
were to register with CDC prior to transfer of select agents. The 
regulation and additional
information may be found at: http://www.cdc.gov/od/sap/42cfr72.htm.
A listing of HHS select agents and toxins in the new select agent 
regulation (42 CFR 73) is
available at http://www.cdc.gov/od/sap.
High Consequence Livestock Pathogens and Toxins are agents that the USDA 
considers to have
the potential to pose a severe threat to animal or plant health, or to 
animal or plant products. A
list of the agents may be found at: 
http://www.aphis.usda.gov/vs/ncie/bta.html.
Agents that appear on both the HHS and USDA list of agents and toxins are 
referred to as
.Overlap Agents.. The list of overlap agents is available at: 
http://www.cdc.gov/od/sap or
http://www.aphis.usda.gov/vs/ncie.
The plant pathogens listed by USDA have been deemed a threat to plant 
health or products. The
list of plant agents and toxins is available at 
http://www.aphis.usda.gov/ppq/permits.
4. Why do I need to register with HHS and USDA for select agents that I 
may possess or use?
Agents identified under the HHS and USDA lists of biological select agents 
and toxins or
USDA.s list of High Consequence Livestock Pathogens and Toxins have been 
deemed a
potential threat to human, animal, or plant health or animal or plant 
products. The registration of
facilities possessing and using these agents or toxins is part of the 
government.s efforts to
improve the ability of the United States to prevent, prepare for, and 
respond to bioterrorism and
other public health emergencies and is required under the Public Health 
Security and
Bioterrorism Preparedness and Response Act of 2002.
Reporting Possession of Select Agents
1. What is the difference between notification and registration?
Under the new Public Health Security and Bioterrorism Preparedness Act, 
all facilities that
possessed an HHS select agent or toxin, or a USDA .High Consequence 
Livestock Pathogens
and Toxins. were required to notify HHS by September 10, 2002 and/or USDA 
by October 11,
2002. This was a one-time notification process. The specific requirements 
for reporting were
published in a Federal Register Notice on July 12, 2002. The notification 
period has passed.
The current HHS Select Agent Program requires facilities to register with 
CDC if they
transferred or received a select agent listed in Appendix A of Title 42 
CFR Part 72. The current
registration process also requires submission of an application that 
certifies that the facility is in
compliance with specific safety and security standards set forth in the 
regulation. More
information is available at http://www.cdc.gov/od/sap.
New Select Agent Regulation FAQ Page 2 of 13
The Public Health Security and Bioterrorism Preparedness and Response Act 
of 2002, required
both HHS and USDA to publish an interim final rule in the Federal Register 
that will describe
the new regulations and registration processes for both agencies.
2. Can I still notify HHS and USDA that I possess select agents?
If you have questions or concerns regarding this activity, please call 
404-498-2250.
General Questions Regarding the New Select Agent Regulation (42 CFR 73)
1. Where can I find a copy of the interim final rule?
The regulation published by HHS concerning HHS and HHS/USDA overlap select 
agents and
toxins (42 CFR 73, December 13, 2002) is available at: 
http://www.cdc.gov/od/sap. The
regulations published by CDC/APHIS for HHS/USDA overlap and USDA high 
consequence
livestock and pathogens and for listed plant agents (9 CFR 121 and 7 CFR 
331, December 13,
2002) are available at: http://www.aphis.usda.gov.
2. Where do I submit comments on the Interim Final Rule (42 CFR 73)?
Written comments pertaining to the Interim Final Rule should be sent to: 
Minh Thomas, Centers
for Disease Control and Prevention, Select Agent Program, 1600 Clifton 
Road, MS E-79,
Atlanta, Georgia 30333 within 60 days of the publication of the Federal 
Register notice. The last
date for comments is February 7, 2003.
3. How was the select agent list determined?
CDC prepared the select agent list for 42 CFR 73 after receiving extensive 
input from scientists
representing 21 Federal government entities. The proposed list was 
published in the Federal
Register for public comment on August 23, 2002.
The HHS Secretary considered the following criteria for establishing the 
list as directed in 42
U.S.C. 262a (a)(1)(B):
. The effect on human health of exposure to the agent or toxin;
. The degree of contagiousness of the agent or toxin and the methods by 
which the agent
or toxin is transferred to humans;
. The availability and effectiveness of pharmacotherapies and 
immunizations to treat and
prevent any illness resulting from infection by the agent or toxin.
4. What is an entity?
An entity is any government agency (Federal, State, or local), academic 
institution, corporation,
company, partnership, society, association, firm, sole proprietorship, or 
other legal entity.
5. Who is affected by the new select agent regulation?
New Select Agent Regulation FAQ Page 3 of 13
The new select agent regulation (42 CFR 73) requires that entities 
possessing biological agents
that are listed as select agents must register with CDC and/or APHIS and 
demonstrate
compliance with specific safety and security standards for handling these 
agents. Any entity that
possesses the select agents and toxins listed in 42 CFR 73, unless 
specifically exempted, are
affected by the regulation. The exclusions and exemptions are discussed in 
questions 6 , 7 and 8
below.
6. What changes will affect CLIA labs? Does 42 CFR 73.6(a)(1) 
automatically include and
replace the previous CLIA exemption?
Any diagnostic or CLIA lab that does diagnostic testing, verification or 
proficiency testing is
exempt from the regulation. The laboratory director must notify HHS 
immediately upon
identifying specific select agents; the entity must transfer the agents to 
a registered facility or
destroy them (unless directed otherwise by law enforcement or HHS) within 
7 calendar days of
identification of the select agent. See number 7 and 8, below. NOTE: 
Retention of any select
agent as a positive control or reference sample is no longer exempt for 
any reason.
7. Who is exempt from the new select agent regulation?
An entity may be exempt from the provisions of the regulation, if:
. The only activities that an entity conducts concerning select agents are 
processing
diagnostic, verification or proficiency specimens or isolates (see ' 73.6 
for details on
additional requirements for these laboratories. Also see number 8, below).
. The entity has select agents or toxins that are cleared, approved, 
licensed, or registered
under any of the laws specified in the regulation, and are used only for 
the approved
purpose of such laws.
. The entity applies to CDC and/or APHIS as appropriate for an exemption 
for select
agents or toxins that are an investigational product authorized under a 
Federal Act listed
in the regulation.
. An exemption is granted by CDC and/or APHIS due to a public health or 
agricultural
emergency.
8. Our entity has been exempt since we are a diagnostic/clinical 
laboratory. What are we
required to do under 42 CFR 73?
. Even if exempt, the entity must immediately report to CDC (telephone: 
404-498-2255,
facsimile: 404-498-2265, or to lrsat at cdc.gov ) the identification of the 
following select
agents: Variola major virus (Smallpox virus) and Variola minor (Alastrim), 
Bacillus
anthracis, Yersinia pestis, Botulinum neurotoxins, Francisella tularensis, 
Ebola viruses,
Marburg virus, Lassa fever virus, and South American Haemorrhagic Fever 
viruses
(Junin, Machupo, Sabia, Flexal, Guanarito).
. The entity reports as required under Federal, State, or local law, to 
appropriate
authorities.
New Select Agent Regulation FAQ Page 4 of 13
. After diagnosis, verification or proficiency testing, the entity either 
transfers the
specimens or isolates to a registered facility or destroys them on-site by 
an appropriate
method.
. Select agents used for diagnosis, verification or proficiency testing 
are transferred or
destroyed within 7 days after identification, unless directed otherwise by 
the FBI or other
law enforcement agency after consultation with the HHS Secretary.
. Select agents used for proficiency testing are transferred or destroyed 
within 90 days after
receipt.
. The entity makes a written record of the identification and transfer or 
destruction on
CDC Form 0.1318, submits the form to the HHS Secretary (within 7 days 
after
identification or 90 days after receipt for proficiency testing).
. The entity maintains a copy of the record for a period of three years.
9. Under what conditions is an entity excluded from the new select agent 
regulation (42 CFR
73)?
The following are excluded from the regulation:
. Select agents or toxins that are in their naturally occurring 
environment, provided that it
has not been intentionally introduced, cultivated, collected, or otherwise 
extracted from
its natural source.
. Non-viable select agent organisms or nonfunctional toxins.
. The vaccine strain of Junin virus (Candid #1).
. It is possible under the new rule to apply for exclusion for any 
attenuated agent or toxin
using an appropriate form obtainable from CDC. Exclusions for specific 
strains may be
granted if the attenuated strain is determined not to pose a significant 
public health or
safety threat. Exclusions will be published in the notice section of the 
Federal Register
and will be listed on the CDC website at http://www.cdc.gov/od/sap.
. Exclusions for entities with specific quantities of toxins under the 
control of a principal
investigator at a given time are also detailed in the regulation (see 
number 10, below).
10. What specific changes in the list of agents take effect in the new 
regulation when compared to
the agents and toxins listed in 42 CFR 72.6? (For USDA only agents see:
http://www.aphis.usda.gov/vs/ncie.)
. Two agents (viruses causing Hantavirus pulmonary syndrome and yellow 
fever virus)
have been removed from the list. One toxin (aflatoxin) was removed from 
the list
previously published in 42 CFR 72.6.
. Several agents have been added to the list of HHS agents, including 
Cercopithecine
herpes virus 1 (Herpes B virus), Monkeypox virus, Coccidioides posadasii, 
and Shigalike
ribosome inactivating proteins.
. Nomenclature changes are as follows:
Equine Morbillivirus Virus has been renamed to Nipah and Hendra Complex 
viruses;
Clostridium botulinum was updated to include botulinum neurotoxin 
producing species
New Select Agent Regulation FAQ Page 5 of 13
of Clostridium. Tick borne encephalitis complex (flavi) viruses are now 
specified by
individual name (Central European Tick-Borne encephalitis (CTBE); Far 
Eastern Tickborne
encephalitis (including Russian Spring and Summer encephalitis (RSSE),
Kyasanur Forest disease, and Omsk hemorrhagic fever). The listing of 
Variola minor
virus (Alastrim) is added to Variola major (smallpox) virus.
Toxins are regulated based on potency and quantity (as opposed to potency 
only or LD50 values
as in 42 CFR 72.6). Entities that do not at any time have more than the 
following aggregate
amounts (in the purified form or in combinations of pure and impure forms) 
under the control of
a principal investigator are excluded from requirements of the regulation:
Abrin 100 mg
Botulinum neurotoxin 0.5 mg
Clostridium perfringens epsilon toxin 100 mg
Conotoxins 100 mg
Diacetoxyscirpenol 1000 mg
Ricin 100 mg
Saxitoxin 100 mg
Shiga-like ribosome inactivating proteins 100 mg
Shigatoxin 100 mg
Staphylococcal enterotoxin 5 mg
Tetrodotoxin 100 mg
T-2 1,000 mg
11. Who must register?
Any entity that possesses, uses, or will receive or transfer any select 
agent or toxin to or from
entities within the US or outside the US are subject to 42 CFR 73.
12. Where can I obtain an application?
In the near future (after February 1, 2003), an application will be 
available from the Select Agent
Program website at www.cdc.gov/od/sap or by directly contacting our office 
via phone at 404-
498-2255 or facsimile 404-498-2265.
13. What are the duties of the Responsible Official (RO)?
The RO is responsible for ensuring compliance with the regulations 
including:
. Developing and implementing safety, security and emergency response 
plans;
. Allowing only approved individuals to have access to select agents or 
toxins.
. Providing appropriate training for safety, security, and emergency 
response.
. Transferring select agents or toxins.
. Providing timely notice of any theft, loss or release of a select agent 
or toxin.
. Maintaining detailed records of information necessary to give a complete 
accounting of
all activities related to select agents or toxins.
New Select Agent Regulation FAQ Page 6 of 13
. Reporting the identification of a select agent or toxin as a result of 
diagnosis, verification
or proficiency testing.
CDC recommends that the RO and alternate RO are biosafety officers or 
senior management
officials of the entity/facility, or both. Although we understand that 
some entities have limited
staff, we recommend that the RO not be an individual actually using, 
working with, or
transferring or receiving the select agents and toxins to minimize 
potential conflicts of interest.
14. What is the responsibility of the alternate RO?
The alternate RO must meet all the qualifications for the RO and must be 
able to conduct all the
activities of the RO (listed above) in the absence of the RO.
15. What agency should the application be submitted to?
The agency that the Responsible Official (RO) should contact is determined 
by the type of select
biological agent or toxin that is possessed.
. For HHS agents, the RO should contact CDC (telephone: 404-498-2255; 
facsimile 404-
498-2265).
. For USDA agents (animal agents and toxins), the RO should contact APHIS
(telephone: 301-734-3277; facsimile: 301-734-3652).
. For HHS/USDA overlap agents, the RO may contact either APHIS or the CDC.
. For plant agents and toxins the RO should contact APHIS (telephone: 
301-734-5519;
facsimile: 301-734-8700).
. A listing of HHS select biological agents and toxins is available at
http://www.cdc.gov/od/sap.
. A listing of USDA animal agents and toxins is available at
http://www.aphis.usda.gov/vs/ncie/bta.html.
. The list of plant agents and toxins is available at 
http://www.aphis.usda.gov/ppq/permits.
16. Will one or both agencies approve applications that include overlap 
select agents?
Regardless of which agency receives the application regarding an overlap 
select agent or toxin,
both agencies will provide input before a determination is made to grant 
or deny a certificate of
registration.
17. What does the registration cover?
The registration will only be valid for the specific select agents and 
toxins and the specific
activities and locations consistent with the information which the 
certificate of registration or
amendment is granted.
18. What if we need to update, change, or amend our registration?
If any change occurs in the information submitted, the Responsible 
Official (RO) of the entity
must obtain prior approval by promptly notifying the CDC in writing in 
accordance with 42 CFR
New Select Agent Regulation FAQ Page 7 of 13
73.21. This includes modifications to the list of individuals that have 
been approved under 42
CFR 73.8 to work/access select agents, changes in work locations, and 
changes in protocols or
objectives of the studies. The entity must submit the information 
requested in the relevant
portion of the application package to the agency that issued the 
certificate of registration.
19. Under what conditions could a registration be terminated?
The HHS Secretary will terminate a certificate of registration based on a 
determination that the
entity no longer conducts activities covered by the certificate. It may 
also be terminated based on
the security risk assessment from Department of Justice, or if the entity 
fails to meet or maintain
safety or security requirements as specified in 42 CFR 73. The HHS 
Secretary may take such
action immediately if necessary to protect the public health or safety. 
Upon such termination the
select agent or toxin possessed by the entity must be destroyed or 
transferred as directed by the
HHS Secretary.
20. Who has to have a security risk assessment?
All entities (except for Federal, State, or local governmental agencies), 
the RO, alternate RO, and
all individuals working with or having access to select agents or toxins 
must have an approved
security risk assessment. An entity may not provide an individual access 
to a select agent or
toxin unless the individual has been approved by the HHS Secretary or USDA 
Secretary based
on this security risk assessment.
21. How does an entity obtain a security risk assessment?
Information will be posted on our website when it becomes available.
22. What criteria are used for determining approval of a security risk 
assessment?
The security risk assessment will evaluate if an individual is a 
restricted person based on the
criteria of the PATRIOT Act http://www.cdc.gov/od/sap/patriot.htm , has 
committed a Federal
crime, is involved with any group that engages in domestic or 
international terrorism or any
organization that engages in intentional acts of violence, or is an agent 
of a foreign power.
23. How long is the security risk assessment valid?
It is valid for a period of three years unless terminated by the HHS 
Secretary sooner.
24. What are the safety requirements of the new regulation?
Each entity must implement a safety plan. This safety plan should 
consider:
. The requirements of the Biosafety in Microbiological and Biomedical 
Laboratories
(BMBL), including all appendices except Appendix F.
. The requirements for handling toxins found in the 29 CFR 1910.1450 and / 
or 29 CFR
1910.1200, and Appendix I of the BMBL.
New Select Agent Regulation FAQ Page 8 of 13
. NIH Guidelines for Research Involving Recombinant DNA (NIH Guidelines) 
for work
with genetic elements, recombinant nucleic acids, and recombinant 
organisms.
25. What are the responsibilities of the RO with respect to the safety 
requirement?
The RO must conduct regular inspections, at least annually, of the 
laboratory where select agents
or toxins are stored or used to ensure compliance with all procedures and 
protocols of the safety
plan. The results of these inspections must be documented and any 
deficiencies must be
corrected.
26. What other safety requirements are included in the new regulation?
An entity may not conduct the following types of experiments unless 
approved by the HHS
Secretary:
. Utilizing recombinant DNA to deliberately transfer drug resistance 
traits to select agents
that are not known to acquire the trait naturally, if such acquisition 
could compromise the
use of drug to control disease agents in humans, veterinary medicine, or 
agriculture.
. Work involving the deliberate formation of recombinant DNA containing 
genes for the
synthesis of select agent toxins lethal for vertebrates at an LD 50 < 100 
ng/kg body
weight.
27. What are the requirements of the security plan?
The specific components to include in the security plan as required by 42 
CFR 73 are located in
the regulation at ' 73.11 http://www.cdc.gov/od/sap/docs/73_11.pdf.
28. What records are entities required to keep and for what duration?
Records that should be kept include: the list of approved individuals that 
may access select
agents, inventories, access to agents and toxins, areas where agents are 
used, and transfer and
destruction documents. These should be maintained for a period of three 
years, as described in
42 CFR 73.15.
29. When and how will inspections take place?
Inspectors from the CDC Select Agent Program will conduct inspections of 
registered entities.
Such inspections may be conducted without prior notification and will 
include a review of all
safety and security aspects, as well as record keeping requirements, 
covered by 42 CFR Part 73.
30. Are there criminal or civil penalties for not being in compliance with 
the new regulation? If
yes, what are they?
Violation of the Public Health Security and Bioterrorism Preparedness 
Response Act of 2002 can
result in substantial fines or imprisonment of up to 5 years, or both. In 
addition, violation of the
Law can result in a civil money penalty of up to $250,000 for individuals 
and $500,000 for an
entity.
New Select Agent Regulation FAQ Page 9 of 13
Questions Regarding the New Select Agent Regulation (42 CFR 73) for
Facilities Currently Registered under 42 CFR 72.6
1. I was just registered for a period of three years, is anything further 
required of our institution
as a result of the new regulation?
Yes. Your RFO/ RO will be receiving a letter describing the requirements 
of 42 CFR 73,
including the necessity to file a new application form. Please note that 
there are phase-in timeline
dates that you are required to meet (see below, number 2).
2. My registration certificate states that we are registered until 2005, 
and yet the regulation says
it is superceded by 42 CFR 73. Does that negate my current registration 
certificate?
The new rule will supercede the previous registration rule according to 
the phase-in timeline
specified in the regulation and you must follow the provisions of the new 
rule to remain
registered to work with select agents and toxins.
The requirements of the first phase-in date become effective on February 
7, 2003. To remain
registered, the entity must complete an application under 42 CFR 73 for 
the effective items set
forth for the February phase-in date, and meet filing requirements at each 
of the subsequent
phase-in date.
Between February 7, 2003 and March 12, 2003, the new application 
compliance requirements
include the designation of a Responsible Official; development of a safety 
plan and laboratory
compliance with the requirements of the BMBL, 29 CFR 1910.1450, and/or NIH 
Guidelines for
recombinant DNA; an emergency response plan; a security risk assessment; a 
record
management system; acknowledgment of inspection requirement; a theft, 
loss, or release
notification procedure; and acknowledgement of administrative review of 
adverse actions, civil
and criminal penalties for violations, and application submission 
requirements.
3. How can I ensure continuity of our registration for Select Agents?
File the new application as it becomes available, and provide 
documentation to the appropriate
agency that your entity meets the requirements of the parts of the rule 
that become effective by
each phase-in date.
4. Our facility has been inactive with respect to select agents, and is 
ready to register at this
point. We are hopeful to begin work sooner than the new regulation takes 
full effect, how do
we proceed, and when can we expect to proceed with work?
File the new application as it becomes available, and meet the 
requirements of the parts of the
rule which become effective by each phase-in date. By meeting the 
requirements for compliance
at each phase-in date of 42 CFR 73, you will receive authorization to work 
with the agents.
New Select Agent Regulation FAQ Page 10 of 13
5. Our institution now has occasion to register additional agents and 
laboratories, is this still a
simple amendment?
If you request an amendment to your registration under 42 CFR 72.6, the 
amendment will only
be effective until the applicable phase-in date of 42 CFR 73. Please note 
that you will be required
to submit an application for all work performed at your institution, 
including the amendment to
meet the requirements of 42 CFR 73 on or around March 12, 2003.
6. How do I determine whether to submit my registration to CDC or USDA for 
the overlap
select agents?
You may submit your new registration package to either agency. A joint 
reporting system has
been developed between CDC and APHIS to approve your application for use 
of HHS/USDA
overlap agents.
7. If I have a CDC select agent and a USDA select agent in the same lab 
with the same
Principal Investigator (PI), do I have to register the same lab with both 
agencies for each
select agent?
Yes. Even if you are registering the same laboratory and PI with the two 
agencies, you must
submit a separate package to each agency for the agent under their 
control.
8. Our registration is about to expire. Are there changes in the process 
since our previous
registration?
There are new requirements and a new application. 42 CFR 72.6 is being 
superceded by 42 CFR
73 on November 12, 2003, with phase-in requirements from February 2003 
through November
2003. Please use the new application when it becomes available 
(information to be posted on our
website) to renew your registration under 42 CFR 73.
9. Will you utilize documentation on file which I have sent in for my 
current registration?
Some documentation on file from your current registration will be used for 
activities such as
transfers under 42 CFR 72.6 until March 12, 2003. After the date the 73.14 
Transfer Section
becomes effective, a new version of the transfer form will be used. To 
accomplish transfers, the
42 CFR 73 application must be on file and approved between February 7, 
2003 and March 12,
2003. New documentation must be submitted because HHS and USDA are 
required to evaluate
and concur on registrations for HHS/USDA overlap agents.
10. It may take some time to have the personnel in our laboratories 
approved for the security risk
assessment by DOJ. How will this affect my registration and the processing 
of our
application?
Your entity will receive an application number when your application has 
been approved under
42 CFR 73. The DOJ component of the rule becomes effective on June 12, 
2003, and compliance
New Select Agent Regulation FAQ Page 11 of 13
with each phase of the registration process will enable you to conduct 
business legally until a
registration number is issued under 42 CFR 73, as it supercedes 42 CFR 
72.6 in November 2003.
11. We have select agents on the exclusive HHS list as well as on the 
exclusive USDA list. How
do we coordinate the registration?
You must register with both agencies if you have agents on both lists. If 
you are also working
with an overlap agent, then continue with your initial registering agency. 
The two agencies will
be jointly reviewing that portion of the evaluation.
12. Currently we only store select agents and toxins, do we have to 
register personnel with access
to the freezers with DOJ?
Yes. You must submit application for a security risk assessment to DOJ for 
any individuals that
require access, including the appointed RO and alternate RO.
13. I just received a letter with a response due date from the inspector 
assigned to my facility. Is
there a process by which I can request to extend this response date?
The regulation specifically provides for an 8 week period of processing of 
the application. This
time is to allow you to provide information that is required, but was not 
furnished with your
application. As noted on the application, information not provided can 
seriously delay processing
of your application, and may result in delaying your registration.
14. We are a facility that is currently registered with CDC to transfer 
select agents, but due to
funding constraints for the select agent project, we are considering 
eliminating the project
and destroying the agent. What should we do?
Until on or around March 12, 2003 when the new transfer section becomes 
effective under 42
CFR 73.14, an EA-101 must be submitted to CDC to report the destruction of 
the agents or
toxins (as specified in 42 CFR 72.6; see 
http://www.cdc.gov/od/sap/docs/attach6.pdf). After
March 12, 2002, CDC must be notified in writing at least 5 business days 
prior to destruction.
Questions Regarding the New Select Agent Regulation (42 CFR 73) for
Facilities Not Currently Registered under 42 CFR 72.6 and Not Currently
Possessing Select Agents
1. I did not possess select agents or toxins prior to February 7, 2003. 
What timeline must I meet
to register my entity?
As of February 7, 2003, to register your entity, you must submit an 
application that certifies
your compliance with the designation of a Responsible Official; 
development of a safety plan
and laboratory compliance with the requirements of the BMBL, 29 CFR 
1910.1450, and/or NIH
Guidelines for recombinant DNA; an emergency response plan; security risk 
assessment;
training requirements; select agent transfer requirements; record 
management system;
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New Select Agent Regulation FAQ Page 13 of 13
acknowledgment of inspection requirement; theft, loss, or release 
notification procedure; and
acknowledgement of administrative review of adverse actions, civil and 
criminal penalties for
violations, and application submission requirements.
As of September 12, 2003, you must submit an amendment to your application 
that certifies your
compliance with the security requirements by developing a security plan. 
As of November 12,
2003, you must be in full compliance with all provisions of the new select 
agent rule.
You must meet the requirements for compliance at each phase-in date of 42 
CFR 73 in order to
be authorized to work with the agent.