Center for Science in the Public Interest

I. Executive Summary
II. Introduction
III. The FDA Plays Politics With Public Health
IV. The FDA is Charged With Protecting Consumers Against Unsafe Foods
V. The FDA Should Establish Standards Through A Fair And Impartial Process
VI. The ISSC Process Is Anything But Fair And Impartial
VII. The Shellfish Industry Has "Captured" The ISSC Process
VIII. How The FDA And ISSC Failed To Protect Consumers
IX. Timeline
X. Conclusions And Recommendations
XI. Endnotes

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 federal agencies.(61)

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.


<<Previous     Next>> <<Contents>>