Table 2.

Summary Table for AAAS Meeting

Theme	Comments / Recommendation
U.S. Health and Human Services Guidance	Comments May inhibit competition and innovation. How will proprietary information be protected? No mechanism for “garage biology” oversight. No mechanism for DNA providers to share customer information. No ongoing, updated database of entities prohibited from obtaining synthetic biology technology. DNA providers may refuse to fill orders for sequences that require additional expenses to participate in oversight programs. No oversight of synthesis providers to assure security and safety. While the purchase of synthesis technology is a private transaction, there is a lack of an established appeal process for refused orders.
	Recommendation Coordinate customer and sequence screening to assure safety and security across all DNA providers. Provide a mechanism to assure safety and security of synthetic biology technology providers. Enhance accountability of all aspects of synthetic biology including reporting and appeal mechanisms.
Customer Screening	Comments No mechanism to determine who is the end-user of technology. Costs associated with compliance may be prohibitory.
	Recommendations Supply precise customer screening modalities and criteria to assure safety and security. Shift some compliance requirements from providers to customer institutions including “Biosafety Committee-like” review boards. Compile, review and update a database of approved customers and consider a licensing requirement to allow purchase of synthetic biology technology.
Sequence Screening Methodology	Comments Automated reviews of DNA sequences are inadequate. Screening against a list does not consider the possible context of use since “sequence does not necessarily predict function.” Innovation and discovery would be inhibited if orders are limited to previously described sequences. Mandatory reporting of DNA sequence orders may compromise proprietary information. Cannot identify sequences changed by end-users. “Best match” determinations that search for sequences that are more similar to harmful than non-harmful patterns are better than “thresholds” but may be below current industry standards. Labeling a sequence as potentially “of concern” does not determine actual harmful nature. Proprietary screening software is inadequate. 200 bp minimum size for sequence screening is inadequate.
	Recommendations Human review of all sequence orders. Compile, review and update a database of harmful sequences. Promote research to determine the fundamentals of harmful sequences and use this information for screening. Create and promote protocols for sequence screening “best practices.” Establish list of subject matter experts for each potentially harmful select agent. Screen each order against any potentially harmful sequence not just those on select agent and Commercial Control Lists. Mandate the use of open-source screening software that is continuously updated. Screen all orders irrespective of sequence length.
Implementation and Evaluation	Comments Success is determined by degree of implementation. The costs of implementation are minimal when compared to other costs of doing business. Regulatory compliance is difficult to determine.
	Recommendations Ongoing, regular governmental communication and interaction with industry and research institutions is critical. Models of illegal and non-compliance methods should be used to evaluate screening modalities. Screening methods require continuous governmental and industry evaluations of effectiveness. Screening methods require ongoing evaluation of financial impact on industry. Effectiveness can be determined in part by the number of providers that claim compliance with regulations and by the number that perform follow-up screening. DNA providers should be certified.
International Engagement	Comments Voluntary compliance and cooperation is crucial to assure safety and security.
	Recommendations Coordinate and streamline international screening of sequences, customers and industry providers.