The FDA Should
Establish Standards Through a Fair and Impartial Process
The FDA typically exercises its FFDCA or PHSA powers by
issuing regulations that govern how foods are produced, processed and stored. The
regulations (or "rules") are legally binding and are created by a process, known
as "notice-and-comment" rulemaking, that itself is governed by legal standards
of fairness and impartiality. Those standards are set out in the Administrative Procedure
Act (APA) and are supposed to apply to substantive rulemakings by the FDA and other
One of the key features of the
"notice-and-comment" process is that all parties-whether an individual consumer,
a large trade association, a group of activists, or a multi-billion-dollar industry-stand
on equal footing before the agency. All are entitled to comment on the proposed
regulations, and the agency must consider all comments in its decision-making process and
must respond to all comments when issuing its final rule.
By contrast, shellfish standards are not established by
notice-and-comment rulemaking. Rather, they are established by a small group of interested
parties largely representing the shellfish industry and states that produce shellfish.
While the FDA is at the helm of the notice-and-comment rulemaking process, it is largely a
bystander in the ISSC program.