Select Agent Regulations

Exam 2

Why do we need regulations?

• people can use select agents for harm

• mistakes can occur (ex: in laboratory)

Who is the regulatory authority?

• CDC

• Department of Health and Human Services (DHHS)

• Animal and Plant Health Inspection Service (APHIS)

• US Department of Agriculture (USDA)

• Interagency Select Agents and Toxins Technical Advisory Committee (ISATTAC)

BSL-1 Requirements

microbes there are not known to consistently cause disease in healthy adults and present minimal potential hazard to laboratories and the environment

• standard microbial practices

• work can be performed on an open lab bench or table

• PPE worn as needed

• doors separate working space and rest of facility

BSL-2 Requirements

• access to lab is restricted when work is being conducted

• appropriate PPE

• procedures that can cause infection from aerosols or splashes are performed within a biological safety cabinet (BSC)

• autoclave for proper disposals

• self-closing doors

BSL-3 Requirements

• lab techs are under medical surveillance + might receive immunizations for microbes they work with

• access to lab is restricted and controlled at all times

• PPE and possible respirators

• work with microbes must be performed within BSC

• exhaust air can’t be recirculated

• sustained directional airflow by drawing air into lab from clean areas towards potentially contaminated areas

• 2 sets of self-closing and locking doors

BSL-4 Requirements

• change clothes before entering

• shower upon exiting

• decontaminate all materials before exiting

• class 3 BSC or fully body positive pressure suit

• lab is in separate building or isolated zone of building

• dedicated supply and exhaust air, vacuum lines and decontamination systems

why are select agents tiered?

select agents and toxins differ greatly in pathogenicity,
toxicity, and ability to be utilized as an agent of bioterrorism
• The risk to humans, animals, and plants vary greatly between
select agents

2010 – Executive Order 13546 HHS and USDA directed to
identify the select agents that pose

• Greatest risk of misuse
• Potential for mass casualties
• Devastating effect to the economy, critical infrastructure and public confidence

Requirements for Working with Tier 1 Select Agents

• conduct annual insider threat awareness briefings on how to identify and report suspicious behaviors

• occupational health program for individuals with access to Tier 1 agents and toxins

• a plan for how the entity will respond to the activation of the alarm system or information on an intruder in the laboratory

• entity will notify the appropriate federal, state, or local law
  enforcement agencies of suspicious activity that may be criminal in nature and related to the entity, its personnel, or its select agents or toxins

• ongoing assessment requirements of individuals with access

• entity’s Responsible Official (RO)
  will coordinate their efforts with the entity’s safety and security professionals to ensure security of Tier 1 select agents and toxins and share appropriate relevant information

• Limit access to laboratories and storage facilities outside of normal business hours to only those specifically approved by RO or designee(s) (security plan)

• Procedures must be in place for screening visitors

• A requirement for three barriers

• intrusion detection system

• plan for event of the failure of the access control system due to power disruption

• must determine the response time for response force

Allowable non-compliance

1. diagnostic, verification, or proficiency testing specimens in clinical
   or diagnostic laboratories

2. products licensed or otherwise approved for use by the federal
   government under specific statutes

3. Investigational products approved by the federal government under
   specific statutes

4. Either the HHS Secretary or the USDA Secretary grant specific
   exemptions due to a public health or agricultural emergency,
   respectively

   
   

Circumstances where the Select Agent Regulations
do not apply

1. Any select agent or toxin that is in its naturally occurring
   environment, provided the select agent or toxin was not intentionally introduced, cultivated, collected, or otherwise extracted from its natural source

2. nonviable select agents or nonfunctional toxins

3. HHS toxins under the control of a principle investigator, treating
   physician or veterinarian, or commercial manufacturer or distributor
   if the aggregate amount does not, at any time, exceed amounts

   
   
   

Transfer or shipping of a select agent must be approved by the CDC or
APHIS PRIOR to the transfer and can only be authorized if the sender

• has an active and approved certificate of registration at the time of
transfer that covers the particular select agent or toxin
• meets the exemption requirements for the particular select agent or
toxin
• is transferring the select agent or toxin from outside the US and
meets all import requirements

Accurate and current records are required for

• each select agent (including viral genetic elements, recombinant
and/or synthetic nucleic acids, and recombinant and/or synthetic
organisms) held in long-term storage (placement in a system
designed to ensure viability for future use, such as a freezer or other
storage container or lyophilized materials)

• any animals or plants intentionally or accidently exposed to or
infected with a select agent (including number and species, location,
and appropriate disposition)

• Inventory of each toxin held and frequently updated