Department of Health and Human Services
42 CFR Part 73
Office of inspector General
2 CFR Part 1003
In December of 2002 the Select Agent Regulation, 42 CFR 73.0,
Interim Final Rule was published. All facilities possessing select
agents or wishing to ship or receive select agents must be registered
with the federal government. All researchers working with or storing
select agents must be included on the University’s Certificate
of Registration with the CDC and must follow all applicable federal
regulations and University policies. Prior approval and training
is required to use, store, ship, or receive a select agent.
Select agents are viruses, bacteria, rickettsiae, fungi, and toxins
that, according to HHS, have the potential to cause substantial
harm to public health.
High Consequence Livestock Pathogens and Toxins are agents that
are considered by USDA to have the potential to pose a severe threat
to animal or plant health, or to animal or plant products. “Overlap
Agents” are agents and toxins that appear on the HHS and USDA lists.
For registration of select agents with EH&S; firstname.lastname@example.org
- Entities possessing select agents must appoint a Responsible
Official (RO). An Alternate Responsible Official (ARO) may also
- Entities possessing select agents must register with either
the CDC or USDA, depending on the select agents possessed.
- Individuals with a legitimate need to work with select agents
must undergo a security risk assessment.
- Only approved individuals may have access to select agents.
- Non-approved individuals must be escorted by an approved person
at all times while in the laboratory.
- The facility must develop and implement a Security Plan.
- Security systems and procedures must be designed according
to a site-specific risk assessment and must provide graded protection
in accordance with the threat posed by the select agent.
- Select agents may only be transferred to registered entities.
- Either the CDC or USDA must approve all transfers of select
agents prior to the transfer.
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- The RO must provide training in biosafety, containment, and
security procedures to individuals with access to select agents.
- The RO must provide annual refresher training.
- Visitors must be informed of the security requirements and
- Suspected loss or theft of select agents must be reported to
the US Department of Agriculture immediately upon discovery.
- Changes in circumstances must be reported by the RO to the
agency that issued the certificate of registration.
- Prior to issuing a certificate of registration, USDA or CDC may inspect and evaluate a facility.
- The RO may inspect the facility at least annually.
The RO must keep records including:
- The Biosafety and Security Plan;
- Current list of individuals with access to select agents;
- Training records for individuals with access to select agents;
- Accurate and current inventory records;
- Permits and transfer documents (USDA 2041);
- Security records (e.g., transactions from automated access
control systems, testing and maintenance of security systems,
- Biosafety, containment, and security incident reports;
All records must be kept for 3 years.
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A Biosafety and Security Plan must be prepared for each entity
possessing select agents or toxins. The University has prepared
a Biosafety and Security Plan for its laboratories possessing select
agents and toxins.
Select agent materials currently regulated under the new
- Live biological agents and toxins (see EH&S website)
- Nucleic acids that encode infectious and/or replication competent
forms of the listed viruses
- Nucleic acids that encode for the functional form of any
of the listed toxins
- Genetically modified select agents and toxins
The following categories of select agent materials are excluded
under the new laws. However, please consult the Environmental Health
and Radiation Safety office before proceeding with any work.
- Agents or toxins present in their naturally occurring environment
(not intentionally introduced)
- Nonviable agents or fixed tissues
- Certain vaccine strains
- Attenuated strains or forms of agents or toxins (must apply
for an exclusion)
- Toxins below the aggregate limits (see EH&S website)
SELECT AGENTS RELATED LINKS