Source: https://www.selectagents.gov/FAQ.html
Timestamp: 2017-09-25 02:42:55
Document Index: 466261726

Matched Legal Cases: ['art 73', 'art 121', 'art 331', 'art 331', 'art 121', 'art 73', 'art 73', 'art 331', 'art 121']

Federal Select Agent Program - FAQ's
Federal Select Agent Program > Compliance > FAQs
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).
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).
Is the RO allowed to have other duties outside of their responsibilities as the RO?
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. For more information, please see the Responsible Official Resource Manual.
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.
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 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 FSAP. 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.
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.
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.
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 here.
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.