Top 10 Most Frequently Asked Questions

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 is a security risk assessment (SRA)?

   An SRA is the electronic records check performed by the Federal Bureau of Investigation (FBI), Criminal Justice Information Services Division (CJIS) to determine whether an entity or an individual who wishes to register to possess, use or transfer a select agent or toxin, or an individual who has been identified by a registered entity as having a legitimate need to access a select agent or toxin meets one of the statutory restrictors which would either prohibit registration or restrict access, respectively.

   The results of an SRA will assist AgSAS or DSAT in its determination that the entity may possess, use, or transfer select agents or toxins; or that an individual may have access to biological select agents and toxins (BSAT).

3. Are security cameras required for compliance with the Select Agent Regulations?

   Surveillance cameras are not required by the Select Agent regulations (42 CFR part 73, 9 CFR part 121 or 7 CFR part 331).

4. Does the "Guidance for the Responsible Official" indicate that the Responsible Official (RO) should not have other duties outside his/her responsibilities as the RO?

   The guidance document states, "Although it is not a violation of the select agent regulations for an individual serving as an RO to have other responsibilities, the Federal Select Agent Program would not recommend this--especially at institutions with large and/or complex select agent programs." As with any other position of responsibility having an impact on the health and safety of individuals, animals, and plants inside and outside the entity, the entity should evaluate the individual's duties based on the size of the entity, the amount of personnel, and the scope of the RO resources.

5. How would the Federal Select Agent Program (FSAP) inspectors verify an entity's suitability assessment program?

   For an entity required to have a suitability program, during their inspection, FSAP inspectors will review the entity’s security plan, any records that the entity maintains as a part of its suitability assessment program (pre-access and ongoing), and interview entity staff. At a minimum, the inspectors will look to see that there is a formal description of the program and that all involved workers have been enrolled and adequately trained.

6. What information and training must an entity provide to meet the requirements of the regulations?

   The regulatory requirements for training are found in Section 15 and Section 11(f)(ii) of the select agent regulations with more detailed information provided in the document "Guidance for Meeting the Training Requirements of the Select Agent Regulations". An entity must provide information and training on biosafety, security (including security awareness) and incident response to each individual with access approval from the Federal Select Agent Program. The training must address the particular needs of the individual and the work they will do and the risks posed by the select agents or toxins they will or may come into contact with. Individuals or visitors not approved for access to select agents and toxins that enter areas where select agent toxins are handled or stored must also receive training based on the hazards of the areas they are entering.

   Entities possessing Tier 1 biological select agents and toxins must also conduct annual insider threat awareness briefings on how to identify and report suspicious behaviors for individuals with access to Tier 1 biological select agents and toxins. Further information can be found in the Guidance for Suitability Assessments and Security Guidance for Select Agent or Toxin Facilities and Guidance for Meeting the Training Requirements of the Select Agent Regulations.

7. Are we required to use a commercial carrier for the domestic shipment within the United States of select agent shipments or can we hand deliver a package containing select agents or toxins to a registered recipient?

   The select agent regulations do not require the use of a commercial carrier for select agent shipments. However, even if an entity chooses to hand deliver a package containing a select agent or toxin to another registered entity it must still comply with section 16 (Transfers) and the transfer must be authorized by Select Agent Program. To initiate the transfer authorization, a CDC/APHIS Form 2 must be completed and sent to the Select Agent Program. In addition, the individual who is hand carrying the package must be SRA approved. The entity also remains responsible for ensuring that all local, state or federal transportation requirements for the transportation of hazardous materials are followed. [Note: If the entity moves the select agent or toxin "in commerce" using a common, contract, or private carriers, U.S. Department of Transportation hazardous materials regulations will apply.] The entity must ensure that adequate precautions are taken to prevent a theft, loss or release of the select agents and toxins. In addition, for animal or plant pathogens, interstate and certain intrastate movements will require a valid APHIS permit.

8. What is the purpose of the APHIS/CDC Form 4A, 4B, and 4C?
   Clinical/Diagnostic Identification (Form 4A)
   

   Any person or entity, including any clinical or diagnostic laboratory, having identified a select agent or toxin contained in a specimen or sample presented for diagnosis or verification is required by the select agent regulations (7 CFR Part 331, 9 CFR Part 121, and 42 CFR Part 73) to report this identification by submitting a completed and signed APHIS/CDC Form 4A to either AgSAS or DSAT. This form can be found at the Federal Select Agent Program website (http://www.selectagents.gov/form4.html).

   Proficiency Testing Identification (Form 4B)

   Any person or entity, including any clinical or diagnostic laboratory, having identified a select agent or toxin contained in a specimen or sample presented for proficiency testing is required by the select agent regulations to report this identification by submitting a completed and signed APHIS/CDC Form 4B to either AgSAS or DSAT. This form can be found at the Federal Select Agent Program website (http://www.selectagents.gov/form4.html).

   Federal Law Enforcement Seizure (Form 4C)
   

   A Federal law enforcement agency that seizes a select agent or toxin is required by the select agent regulations to report this seizure by submitting a completed and signed APHIS/CDC Form 4C to either AgSAS or DSAT. This form can be found at the Federal Select Agent Program website (http://www.selectagents.gov/form4.html).

9. Who must register with the Federal Select Agent Program?

   An individual or entity that intends to possess, use, or transfer any select agent or toxin, including receipt of select agents and toxins from outside the United States, must register with either Department of Health and Human Services (HHS)/Centers for Disease Control and Prevention (CDC)/Division of Select Agents and Toxins (DSAT) or U.S. Department of Agriculture (USDA)/Animal and Plant Health Inspection Service (APHIS)/ Agriculture Select Agent Services (AgSAS) (collectively known as the Federal Select Agent Program). Specific exemptions for clinical or diagnostic laboratories and federally authorized products that may apply in certain situations are found in sections 5 and 6 of the regulations (42 CFR Part 73, 7 CFR Part 331 and 9 CFR Part 121). Sections 3 and 4 of the regulations also establish criteria for when agents or toxins are excluded from the requirements of the select agent regulations.

   The current Select Agent Regulations can be found at http://www.selectagents.gov/Regulations.html.

10. 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 into law the "Public Health Security and Bioterrorism Preparedness and Response Act of 2002" (the Act). The Act is designed to improve the ability of the United States to prevent, prepare for, and respond to bioterrorism and other public health emergencies.

    Section 201(a) of the Act amends the Public Health Service Act by adding section 351A (Enhanced Control of Certain Biological Agent and Toxins) (42 U.S.C. 262a) that requires all persons possessing, using or transferring those biological agents or toxins designated by the Secretary of the U.S. Department of Health and Human Services (HHS Secretary) as having the potential to pose a severe threat to public health and safety (i.e., HHS select agents and toxins) to register with the HHS Secretary and meet biosafety and security standards and procedures established by the HHS Secretary. The Centers for Disease Control and Prevention (CDC) has been designated as the HHS agency responsible for promulgating, implementing, and providing guidance on 42 CFR Part 73. The HHS Select Agent regulations can be found in Part 73 of Title 42 of the Code of Federal Regulations (42 CFR Part 73).

    Section 212 of the Act (cited as the Agricultural Bioterrorism Protection Act of 2002, 7 USC 8401) requires all persons possessing, using or transferring those biological agents or toxins designated by the Secretary of the U.S. Department of Agriculture (USDA) as having the potential to pose a severe threat to animal or plant health or to animal or plant products (i.e. USDA select agents and toxins) to register with the USDA Secretary and meet biosafety and security standards and procedures established by the USDA Secretary. The USDA Select Agent regulations covering threats to animals and animal products can be found at Part 121 of Title 9 Code of Federal Regulations (9 CFR Part 121). The Animal and Plant Health Inspection Service (APHIS) has been designated as the USDA agency responsible for promulgating, implementing, and providing guidance on 9 CFR Part 121 and 7 CFR Part 331. The USDA Select Agent regulations covering threats to plants and plant products can be found at Part 331 of Title 7 Code of Federal Regulations (7 CFR Part 331).

    The Act can be found at the Federal Register website http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=107_cong_public_laws&docid=f:publ188.107.