Reference Material and Related Resources

Referenced Reports | Customer Screening References | Sequence Screening Resources
Processes for Domestic and International Orders | Follow-Up Screening & Contact Information  

Referenced Reports

• NSABB Report: Addressing Biosecurity Concerns Related to the Synthesis of Select Agents
• CDC/APHIS Guidance: Applicability of the Select Agent Regulations to Issues of Synthetic Genomics

Customer Screening References - Guidance Section: V(A)

• U.S. Code Title 18 Section 175(b):  “Whosoever knowingly possesses any biological agent, toxin, or delivery system of a type or in a quantity that, under the circumstances, is not reasonably justified by a prophylactic, protective, bona fide research, or other peaceful purpose, shall be fined under this title, imprisoned not more than 10 years, or both.”
• U.S. Code Title 18 Section 3286

Sequence Screening Resources - Guidance Section: V(B)

Select Agents

• Select Agent Regulations: Within the U.S., microbial organisms and toxins that have been determined to have the potential to pose a severe threat to public health and safety, animal health, plant health, or animal or plant products are regulated through the Select Agent Regulations, administered by the Department of Health and Human Services/Centers for Disease Control and Prevention (HHS/CDC) and the U.S. Department of Agriculture/Animal and Plant Health Inspection Service (USDA/APHIS).
• Select Agent Exclusions:  Attenuated strains that are not subject to the requirements of 42 CFR Part 73, 9 CFR Part 121, and 7 CFR Part 331.  These attenuated strains of Select Agents and Toxins have been excluded from regulation but share high sequence similarity with some Select Agents and Toxins.

Plant and Animal Diseases Requiring Interstate and International Transportation Permits

• Plant Pests - 7 CFR part 330
• Infectious diseases of animals - 9 CFR part 122

Screening Databases and Programs

• GenBank:  A public database of genetic sequences run by the National Institutes of Health 
• BLAST:   A popular and publicly available suite of algorithms used for sequence screening

Processes for Domestic and International Orders - Guidance Section: VI

Domestic Customers: Lists of Proscribed Entities

• Department of Treasury Office of Foreign Assets Control (OFAC) list of Specially Designated Nationals and Blocked Persons (SDN List)
• Department of State list of persons engaged in proliferation activities
• Department of Commerce Denied Persons List (DPL)

Additional Requirements/Resources for International Orders

• Introduction to export controls
• Relevant Parts of the Export Administration Regulations and Commerce Control List
• Australia Group:  As a member of the Australia Group, the United States requires exporters through the EAR to obtain export licenses for exports of reading-frame length nucleic acid sequences from pathogens listed under Export Control Classification Numbers (ECCNs) 1C351, 1C352, 1C353, and 1C354.
• Department of Treasury Office of Foreign Assets Control (OFAC) list of Specially Designated Nationals and Blocked Persons (SDN List)
• Department of State list of persons engaged in proliferation activities
• Department of Commerce Denied Persons List (DPL)
• Department of Commerce’s Bureau of Industry and Security (BIS)
• International Emergency Economic Powers Act
• Trading with the Enemy Act
• The Unverified List

Follow-Up Screening & Contact Information for Necessary Offices

• Department of Commerce: The supervisory office is in Washington, D.C. and can be contacted at 202-482-1208.
• Department of Commerce field offices
• Export counselors at the Department of Commerce: 202-482-4811.
• CDC Select Agent Program - lrsat@cdc.gov or by fax at 404-718-2096 or through www.selectagents.gov
• APHIS Select Agent Program - Agricultural.Select.Agent.Program@aphis.usda.gov or by fax at 301-734-3652 or through www.selectagents.gov
• FBI WMD Directorate
• FBI Field Offices