As referenced earlier in this space, the Food Safety and Inspection Service (FSIS) hosted a public meeting on Whole Genome Sequencing (WGS) issues late in October (see meeting agenda). It provided a range of helpful information on the implications of the rapid and ongoing adoption of such technology by FSIS and other actors in the public health community at both federal and state levels. Also, in the nature of such events, it generated questions, particularly with regard to some of the core legal issues that surround WGS adoption.
Such questions could be grouped into three general areas:
- The regulatory implications of publicly generated data.
- Related issues regarding the potential generation of private data.
- With broader implications, the identification and classification of potential adulterated food products.
In the first area, many of the presenters tended to push back against what has been termed the “CSI phenomenon”—the notion that such data automatically generates cause-and-effect information that leads to unambiguous scientific regulatory conclusions. To the contrary, it was emphasized that such data can, should, and must be evaluated in a broader context that includes, most critically, epidemiological information. This has clear near-term regulatory implications in underlining the point that sample result X does not automatically dictate recall of product Y, absent additional context. In the longer term, it also bears upon more far-reaching concerns over retroactive impact, should some type of match be made between a sample result taken from a facility years in the past with a current product in the marketplace in a way that could bring into question the regulatory status of all production generated in the interim.
Questions involving the generation of private WGS data and the related ability of private actors to protect such data’s confidentiality were also up for discussion. But such discussion is influenced and complicated by FSIS’s traditional policy of interpreting its HACCP regulations in an aggressive manner, potentially making any such data relevant to the establishment’s hazard analysis, and thus available to the agency upon request. While there was some acknowledgment of the value of encouraging the carve-out of research and development, resolution of this point remains elusive.
Finally, and perhaps most interestingly, questions emerged surrounding broader long-term implications for agency determinations of product adulteration. If, on a case-by-case basis, such technology enables regulators to make more refined distinctions between products that might or might not be unsafe for human consumption, such distinctions also can and should be brought to bear on current broad definitions of adulterants at the level of serotyping. Given the significance of such issues, several participants at the meeting made the point—not often heard at a scientific gathering—that there is a greater need for the involvement of lawyers in this process moving forward.
As always, if you have any questions, please do not hesitate to contact us.