Screening Framework Guidance for Providers of Synthetic Double-Stranded DNA

This guidance has been superseded by the 2023 Screening Framework Guidance for Providers and Users of Synthetic Nucleic Acids.

The primary goal of the Screening Framework Guidance for Providers of Synthetic Double-Stranded DNA – issued by HHS in 2010 – was to minimize the risk that unauthorized individuals or individuals with malicious intent will obtain “toxins and agents of concern” through the use of nucleic acid synthesis technologies, and to simultaneously minimize any negative impacts on the conduct of research and business operations. The guidance was developed, taking into consideration providers’ existing protocols, to be implemented without unnecessary cost and to be globally extensible, both for U.S.-based providers operating abroad and for international providers.

Providers of synthetic dsDNA have two overriding responsibilities in this context:

Providers should know to whom they are distributing a product.
Providers should know if the product that they are synthesizing and distributing contains, in part or in whole, a “sequence of concern".

The guidance outlines a screening framework that will assist providers in meeting both of these responsibilities. Though certain guidance provided in this document is necessarily framed by U.S. policy and regulations, the guidance was composed so that fundamental goals, provider responsibilities, and the screening framework could be considered for application by the international community. In particular, items included in the Biological Select Agents and Toxins List and the Commerce Control List that are the primary focus of the guidance may not be relevant for all countries. The sequence screening framework can be applied to other categories of agents and toxins that may be relevant for other regions

Reports

2010 Screening Framework Guidance for Providers of Synthetic Double-Stranded DNA

Screening Framework Guidance for Providers of Synthetic Double-Stranded DNA This the guidance was published in the Federal Register on October 13, 2010

2009 Draft Screening Framework Guidance for Synthetic Double-Stranded DNA Providers

2009 Screening Framework Guidance for Synthetic Double-Stranded DNA Providers: This 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

NSABB Report: Addressing Biosecurity Concerns Related to the Synthesis of Select Agents

National Research Council

National Research Council report, Sequence-Based Classification of Select Agents: A Brighter Line

Customer Screening References - Guidance Section: V(A)

U.S. Code Title 18 Section 175(b)

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

U.S. Code Title 18 Section 3286: Extension of statute of limitation for certain terrorism offenses

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

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

Screening Framework Guidance for Providers and Users of Synthetic Nucleic Acids

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