Reference Material and Related Resources
2010 Screening Framework Guidance for Providers of Synthetic Double-Stranded DNA
Referenced Reports
2009 Screening Framework Guidance for Synthetic Double-Stranded DNA Providers: This the guidance was made available for public consideration and comment in the Federal Register for a period of 60 days beginning on November 27, 2009.
Response to Public Comments: This Response to Public Comments document provides a general review of the decisions made to alter the Guidance in response to public comments.
NSABB Report: Addressing Biosecurity Concerns Related to the Synthesis of Select Agents
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: Extension of statute of limitation for certain terrorism offenses
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 Pests - 7 CFR part 330
Infectious diseases of animals - 9 CFR part 122
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 State list of persons engaged in proliferation activities
Department of Commerce's Bureau of Industry and Security (BIS)
Department of Commerce: The supervisory office is in Washington, D.C. and can be contacted at 202-482-1208.
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