Guidance Documents

Plan and Personnel Guidance

Annual Inspection GuidanceThis document is intended to provide guidance and assist entities regarding the regulatory requirement that the Responsible Official (RO) ensure that an annual inspection is conducted for each registered space where select agents or toxins are stored or used.
Biosafety/Biocontainment Plan GuidanceThis document provides guidance for developing and implementing a biosafety/biocontainment plan in accordance with section 12 of the select agent regulations. This includes definitions, plan provision requirements, hazardous characteristics, and a Biosafety/Biocontainment Plan Template.
Drills and Exercises GuidanceThis document provides guidance for developing, implementing, and documenting drills and exercises in accordance with sections 12, 13, and 14 of the select agent regulations.
Guidance for Select Agent Regulation Training RequirementsThis document provides guidance for meeting the training requirements of the select agent regulations. Topics include what types of training are required, training programs, frequency requirements, and training records.
Incident Response PlanThis document provides guidance for developing and implementing an incident response plan in accordance with section 14 of the select agent regulations. This includes information regarding requirements, natural disasters, and the goals of incident response planning.
Information Systems Security Controls GuidanceThis document provides guidance for developing and implementing robust information systems controls and information security provisions in accordance with the select agent regulations. Information includes Network Security, Access Authentication, Application Systems Security Controls, Patching and Backups, and Industrial Core Systems.
Occupational Health ProgramThis document provides guidance for developing and implementing an Occupational Health Program for entities that possess or use Tier 1 select agents and toxins. This includes information about Tier 1 precautions, medical assessments and surveillance, post exposure management, hazard communication, and more.
Responsible Official Resource ManualThe Responsible Official Resource Manual provides guidance on a broad range of subjects relevant to the duties and obligations of the entity’s Responsible Official and Alternate Responsible Officials. Information includes fundamental responsibilities, authority, delegating, compliance, reporting, records, and internal inspections.
Security Plan GuidanceThis document provides guidance for developing and implementing a security plan in compliance with section 11 of the select agent regulations. This includes information regarding site-specific risk assessments, planning requirements, access, inventory and audits, and barriers.
Security Risk Assessment ToolThis tool assists in creating the entity’s site-specific risk assessment, which is the core of a robust security plan.
Suitability Assessment Program GuidanceThis document provides guidance for developing and implementing the pre-access and ongoing suitability assessment programs for entities that possess or use Tier 1 select agents and toxins. This includes leadership requirements, access privileges, training requirements, visitor policies, and example interview questions.

Shipping and Storage Guidance

Guidance for Completing the Shipper’s Declaration for Dangerous GoodsThis document provides step-by-step instructions for filling out a Shipper’s Declaration for Dangerous goods correctly to avoid delay in the transfer of select agents and toxins.
Guidance on the Inventory of Select Agents and ToxinsThis document provides information regarding the inventory of select agents and toxins for long term storage, including definitions, storage criteria, and record maintenance.
Guidance on the Transfer of Select Agents and ToxinsThis document provides guidance on how to safely transfer select agents and toxins in compliance with federal select agent regulations.

Select Agent and Toxin Use Guidance

Avian InfluenzaThis document provides guidance for the regulation of Avian Influenza, including categorization, biocontainment, and the transfer of Highly Pathogenic and Low Pathogenic Avian Influenza viruses.
Exclusion GuidanceThis document provides guidance on regulatory exclusions, the exclusion request and review process, and exclusions by federal law enforcement agencies.
Guidance on the Inactivation or Removal of Select Agents and Toxins for Future UseThis document provides guidance on the requirements for inactivating or removing select agents and toxins for future use. This includes definitions; the development, validation, and verification of inactivation procedures, and failure reporting requirements.
Guidance on the Regulation of Select Agent and Toxin Nucleic AcidsThis document provides information on the regulation of select agent and toxin nucleic acids, including regulated materials, non-regulated materials, and working with FSAP-regulated genomes at lower containment.
Restricted Experiments GuidanceThis document includes information regarding examples of potential restricted experiments, restricted experiments requests, and transfers of products resulting from restricted experiments.
Select Toxin GuidanceThis document provides guidance on meeting the requirements for possessing or using select toxins. Information includes non-regulated amounts of select toxins, requirements for Botulinum neurotoxin and Botulinum neurotoxin producing species of Clostridium, exclusions and exemptions, inventory requirements, importation requirements, and more.

Page last reviewed: September 10, 2020

Content source: Division of Select Agents and Toxins