January 14, 2010 - ASM Comments on the Screening Framework Guidance for Synthetic Double-Stranded DNA Providers
Jessica Tucker, Ph.D.
Office of Medicine, Science and Public Health
Office of the Assistant Secretary for Preparedness and Response
U.S. Department of Health and Human Services
330 C Street, SW
Washington, DC 20201
Re: Screening Framework Guidance for Synthetic Double-Stranded DNA Providers
Dear Dr. Tucker:
The American Society for Microbiology (ASM) is submitting the following written comments on the proposed Screening Framework Guidance for Synthetic Double Stranded DNA Providers Notice, published in the November 27, 2009, Federal Register, by the Office of the Secretary, of the Department of Health and Human Services (HHS). The ASM is the largest single life science organization with approximately 40,000 members, who are involved in basic and applied research, clinical diagnostic testing, public health, education and industry. The ASM recognizes that synthetic biology, while contributing greatly to the advancement of biomedical research which is the core of the development of biodefense measures, has the potential for misuse. Thus, the ASM supports measures that enhance biosecurity without interfering with the advancement of biodefense research that is critical for the development of vaccines, therapeutics, and diagnostics. Following are comments which the ASM would like to make on the proposed Guidance for Synthetic Double Stranded DNA Providers:
- Voluntary guidance such as proposed by the US Government can contribute to biosecurity. However, given that gene synthesis is now routinely performed in numerous laboratories and by many commercial enterprises around the world, harmonized actions need to be taken internationally to be effective. It is important to biosecurity and US competitiveness that the overseas counterparts to US based companies follow a common screening guidance framework so that US companies do not face a marketplace disadvantage. We recommend that the Department of State be given the responsibility of working with international organizations such as the Organization for Economic Cooperation and Development (OECD) and the Parties to the Biological Weapons Convention to foster international cooperation and harmonization so as to ensure that there is international agreement on a common screening guidance framework.
- A key aspect of the voluntary oversight by commercial vendors of synthetic DNA is the "trustworthiness" of those seeking synthetic gene sequences. It would be helpful if the US Government and governments of other countries provided a service that would allow vendors to seek rapid government assessments of the "legitimacy" of those seeking synthetic DNA sequences of genes involved in virulence and pathogenesis. This potentially would shift responsibility to the government rather than the industry level.
- The guidance should focus on synthetic DNA sequences that encode for a recognized domain of a toxin or virulence factor of a select agent, regardless of the size of the sequence.
- Although the guidance is voluntary, specific recommendations remind providers that they have obligations under existing regulations including the Select Agent and Toxins regulations, the Commerce Control EAR List and ITAR. Further, the Notice informs providers of activities that require compliance with statutory and regulatory obligations. In this regard, questions arise with respect to certain terms used in the Notice and with respect to the extent to which compliance with regulatory requirements may be expedited or made less time consuming or costly. For example, does the screening for customers comport with the realities of the marketplace? In other words, are the “customers” the buyer or are their “middlemen,” “traders,” “agents” or the like that would purchase the materials? Does the screening of customers raise any trade secret or confidential information concerns? If so, how should such matters be handled? If a customer has been screened once, must that customer be “screened” for subsequent transactions? Would there be a constant need to screen customers to determine whether there has been is a change in ownership or management? Will appropriate agencies compile a list of “registered” buyers (voluntary basis) who would be permitted to place orders without initial customer screening be developed? Will “screening” require the addition of personnel and would it require specialized training?”
- The following statement in the notice is unclear: “The U.S. Government acknowledges that there are synthetic nucleic acid sequences from non Select Agents or Toxins that may pose a biosecurity concern. Synthetic nucleic acid providers may choose to investigate such sequences as part of their best practices. However, due to the complexity of determining pathogenicity and because research in this area is ongoing, a list of additional non Select Agent or Toxin sequences or organisms to screen against would not be comprehensive and consequently are not provided by the U.S. Government in this guidance.” Is the screening focused solely on select agents or is it intended to include virulence and pathogenicity sequences from agents on the NIAID and CDC lists?
- The notice does not address the issue of what software and databases will be used for assessment and what sequences will the synthetic DNAs be screened against. What will be considered a true “hit” versus not and who will set the homology threshold?
- The notice recommends separate screening for Select Agents and Toxins versus the Export Administration Regulations Commerce Control List (EAR CCL). This overlap applies to “foreign orders.” Are there means by which such duplicative sequence screening could be minimized?
- Are there “standard” orders in commerce for synthesized double-stranded DNA for which the screening processes should not be necessary? In other words, could there be a list of sequence materials that would obviate even customer screening? Could there be lists of “approved customers” and of “approved sequences”?
- The recommendation states, “The U.S. Government recommends that providers develop, maintain, and document their sequence screening protocol within company records.” The timeline for record keeping is not clear.
The ASM appreciates the opportunity to comment on the Screening Guidance for Synthetic Double Stranded DNA and would be pleased to work with the US Government as the document is considered further in the interagency process.
Roberto Kolter, Ph.D., President, American Society for Microbiology
Ruth L. Berkelman, M.D., Chair, Public and Scientific Affairs Board
Ronald M. Atlas, Ph.D., Chair, Committee on Biodefense
Kenneth I. Berns, M.D., Ph.D., Chair, Committee on Biodefense