General

1. What are the categories of biological containment in use?

   The term "containment" is used in describing safe methods for managing infectious materials in the laboratory environment where they are being handled or maintained. The purpose of containment is to reduce or eliminate exposure of laboratory workers, other persons, and the outside environment to potentially hazardous agents.

   Primary containment, the protection of personnel and the immediate laboratory environment from exposure to infectious agents, is provided by both good microbiological technique and the use of appropriate safety equipment. The use of vaccines may provide an increased level of personal protection.

   Secondary containment, the protection of the environment external to the laboratory from exposure to infectious materials, is provided by a combination of facility design and operational practices. Therefore, the three elements of containment include laboratory practice and technique, safety equipment, and facility design. The risk assessment of the work to be done with a specific agent will determine the appropriate combination of these elements.

2. What documentation does Federal Select Agent Program require, to verify the ability of a BSL-3/ABSL-3 HVAC system to maintain secondary containment under failure conditions?

   When tests are performed of exhaust fan failure or of normal power failure/restart, monitoring of the containment laboratory's differential pressure or airflow must be performed and recorded by some means throughout the testing period. Two examples of how this monitoring may be done are: witness observations of airflow using a smoke stick, or dry ice in a container of water, at the base of closed laboratory doors; or pressure differential trending data collected by a building automation system or by witness observations of gauges. The results recorded during the tests must be provided as part of the test documentation.

3. Is there a requirement to perform failure tests of multiple exhaust fans at the same time?

   If redundant exhaust fans are present, a test should be performed to demonstrate the ability to transition to an alternate fan without reversal of airflow from potentially contaminated laboratory space into "clean" areas outside the containment boundary. There is no requirement to perform a catastrophic failure or institute a total systems shutdown for multiple exhaust fans. However, it may be beneficial to perform such a test when re-commissioning is required.

4. If the facility design includes backup emergency power, does Federal Select Agent Program require that an electrical system load switch, from utility power to generator, be performed for the normal power failure/restart test?

   No, an electrical load switch is not specifically required, because of the disruptive effect which electrical load switching may have on building occupants and the potential hazards to electrical components. The load switch is one option for the performance of normal power failure/restart testing. Another option is to simulate the loss and restart of normal power by simultaneously shutting off both the supply and the exhaust fans which serve the laboratory space, while monitoring and recording the differential pressure or airflow, and then simultaneously turning on both the supply and the exhaust fans, while monitoring and recording airflow or differential pressure.

Occupational Health Program

1. Are pre-placement physicals required for new hires as part of the occupational health program or can they submit screening questionnaires or medical self-assessments?

   The entity may use a medical self-assessment form, screening questionnaire or a pre-placement physical to complement the occupational health program. However, this is not a requirement of the regulations.

2. Are pre-placement physicals required for existing employees as part of the occupational health program or are annual animal allergy screening and respirator questionnaires adequate?

   The entity may use an annual animal allergy screening, respirator questionnaire or a pre-placement physical to complement the occupational health program. However, this is not a requirement of the regulations.

3. Are employees available to opt out of the entity's occupational health program?

   Individuals with access to Tier 1 select agents and toxins must be enrolled in the entity's occupational health program.

4. Do personnel working with excluded attenuated strain of a select agent or toxin need to be enrolled in an entity's occupational health program?

   No, attenuated strains of select agents or toxins that have been excluded are not subject to the select agent regulations.

   Note: An individual or entity that possesses, uses, or transfers an excluded attenuated strain will be subject to regulation if there is any reintroduction of factor(s) associated with virulence or other manipulations that modify the attenuation such that virulence is restored or enhanced.

5. Does the Biosafety in Microbiological and Biomedical Laboratories (BMBL) indicate that serum banking is suggested for work with select agents in Biosafety Level (BSL) 4?

   The BMBL, 5^th ed. (p. 47) states that "Each institution should consider the need for collection and storage of serum samples from at-risk personnel."

   If there is a benefit to the entity (e.g., aids in the detection for diagnosis), it may use serum banking to complement occupational health program. When developing an occupational health program, the entity should discuss the benefits versus the costs and concerns (e.g., efficacy of samples over time) of serum banking.

6. Are there corresponding biosecurity levels that associate with biosafety levels (e.g., work with agents in BSL2 has corresponding biosecurity levels)? For example, does Botulinum neurotoxin producing species of Clostridium that can be worked in BSL2 laboratory and listed as Tier 1 agent, have biosecurity requirements associated with a BSL3 laboratory?

   There are no specific biosecurity levels associated with biosafety levels. Information about containment and classification of biosafety levels 1-4 is available in the BMBL. Entity security measures must be sufficient to safeguard the select agent or toxin against unauthorized access, theft, loss, or release.

7. Does an entity's employee health program cover the requirement for an occupational health program if it includes blood borne pathogen standard, aerosol transmissible diseases, and respiratory protection?

   The entity may use an employee health program to complement the occupational health program (OHP). However, this is not a requirement of the regulations. A key component of the OHP is to ensure that the professional healthcare provider is informed of the potential hazards posed by the select agents or toxins and the level of risk given its intended use. With this information, a program can be developed to address the identified issues.

8. Are employees required to take vaccinations or is the employer required to offer vaccinations to employees or visitors as part of the occupational health program?

   The entity may offer vaccinations to the employees to complement the occupational health program. However, this is not a requirement of the regulations.

9. Is there a requirement to report a laboratory acquired infection (LAI) to the local health department?

   Yes, it would depend on your state and local requirement.

10. Are maintaining baseline serum samples required as part of the occupational health program?

    The entity may maintain baseline serum samples to complement the occupational health program. However, this is not a requirement of the regulations.

    The BMBL recommends institutions performing work with certain virus (i.e., Severe Acute Respiratory Syndrome (SARS) Coronavirus) should require storage of a baseline serum sample from individuals who work with the virus or virus-containing specimens.

    If there is a benefit to the entity (e.g., aids in the detection for diagnosis), it may use serum banking to complement occupational health program. When developing an occupational health program, the entity should discuss the benefits versus the costs and concerns (e.g., efficacy of samples over time) of serum banking.

11. Are animals inoculated with Botulinum neurotoxins considered to be select toxins? What is the best protocol to discard these animals considering they have been inoculated in a BSL3 facility?

    Animals injected with or exposed to a select toxin are not considered a "select toxin."

    The BMBL provides recommendations to institutions performing work with Botulinum neurotoxins based on the work being performed with the toxin. This information is available at: http://www.cdc.gov/biosafety/publications/bmbl5/index.htm.

12. Will clinical laboratories that meet the exemption provisions be required to develop an occupational health program if they identify a Tier 1 select agent?

    No, an entity that possesses a select agent or toxin that is contained in a diagnostic or verification specimen or sample is exempt from the requirements of the select agent regulations for that specific select agent or toxin so long as the entity does the following:

    • Unless directed otherwise by the Federal Select Agent Program, within seven calendar days after identification of the select agent or toxin, either transfers the select agent or toxin in accordance with section 16 of the select agent regulations (requires prior approval by the Federal Select Agent Program) or destroys the specimen on-site by a recognized sterilization or inactivation process.
    • Before transfer or destruction, secures the select agent or toxin to prevent theft, loss, or release.
    • Immediately report the identification of specific select agents and toxins listed in the regulations (See immediate notification list). Additionally, an APHIS/CDC Form 4A must be sent to the Federal Select Agent Program within seven calendar days after identification.
    • Maintain copies of all APHIS/CDC Form 4A reports for a period of three years.

    
    

    NOTE: The retention of a diagnostic, verification, or proficiency sample which has been identified as positive for a select agent by an individual or entity that is not registered with the Federal Select Agent Program is a violation of Federal law. Such possession would include the retention of a select agent or toxin which had been identified from a diagnostic or verification specimen as a positive control or reference sample.