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 ISSC Process Is Anything But Fair and Impartial

Safety standards purportedly designed to prevent contamination of shellfish with pathogens such as Vibrio vulnificus are established by the ISSC and set forth in the Shellfish Model Ordinance.(62) The FDA gave away an important part of its public-health mandate by structuring the ISSC such that the FDA cannot change the Model Ordinance unilaterally.(63) That is, Model Ordinance provisions may only be adopted, altered, or eliminated by means of the formal ISSC process.(64)

Under the ISSC process, shellfish standards in the Model Ordinance may be added or amended only at ISSC annual meetings.(65) Anyone may submit a proposal as an "issue" for consideration at an ISSC meeting. Issues are deliberated at the meeting at three sequential stages: (1) committee meetings; (2) meetings of the three ISSC task forces; and (3) by the voting delegates at the General Assembly.


ISSC committees review proposals and make recommendations on issues that were considered but not resolved at previous annual meetings. The size and composition of the committees and subcommittees vary, but in all cases industry representatives enjoy the same voting rights as the local, state, and federal regulators who serve on the committees. This is the only level at which consumers or their representatives are allowed to vote.

Task Forces

The ISSC Task Forces are the next to consider issues that were considered but not resolved at previous meetings. Task Forces also are the first bodies to consider new proposals. The three Task Forces handle different topics:
  • Task Force I-Growing Areas, deals with the classification and patrol of shellfish growing waters;
  • Task Force II-Processing and Distribution, handles the sanitation of harvesting, processing, and distribution; and
  • Task Force III-Administration, covers program evaluations, Conference agreements, and similar matters.(66)

Each task force has eight voting members, equally balanced between state regulatory agencies and the shellfish industry.(67) The task force chairs, who cast the deciding vote in the case of ties, are alternately selected from state shellfish control agencies and from the industry.(68) Consumers and consumer representatives are not allowed to be members of task forces. Though FDA officials may serve as consultants to each task force, they are not members and have no vote.(69)

Task forces are extremely influential in the process, because they are the last group able to amend an issue before it is voted upon by the delegates, who only may vote the issue up or down.(70) As a result, industry representatives play a determinative role in shaping the issues before the final vote at the General Assembly.

Art. I, §2. The Conference shall be directed by and shall be under the control of the various states, federal agencies and shellfish industry who join together to form the Conference.
Art. II, §1. The objective of the Conference shall be to foster and improve the sanitation of shellfish in this country and to encourage restoration of shellfish growing areas.

General Assembly of Voting Delegates

The final, and decisive, ISSC body to consider proposals is the General Assembly of voting delegates. Each member state of the ISSC may designate as a voting delegate one or more of its regulators responsible for administering the state’s shellfish-sanitation program.(71) For those states in which more than one agency administers the NSSP, the single vote may be divided among representatives from each agency. An unfortunate consequence is that states may allocate all or a portion of their vote to state agencies responsible for promoting their state’s shellfish products and not state public-health agencies.

FDA Concurrence

Issues approved by the voting delegates during the final General Assembly do not go into effect until the FDA formally concurs in their adoption.(72) Once the FDA has concurred, the change takes effect upon publication of the next revision of the Model Ordinance, unless the voting delegates have specified a different implementation date.(73) If the FDA does not concur, it must convey a written decision, with supporting rationale, to the ISSC Chair, who then refers the issues to the ISSC Executive Board for further discussion or to the next annual meeting for reconsideration.(74) While on paper that process may appear to be reasonable, in reality the FDA finds it politically difficult to wield its non-concurrence power.

ISSC Executive Board

The ISSC Executive Board "manages the affairs of the Conference."(75) As such, the Board is empowered to act on behalf of the ISSC voting delegates between full ISSC meetings.(76)

The ISSC Executive Board is stacked in favor of industry. It consists of 18 voting members and several non-voting members. Six of the voting members come from the shellfish industry, and six are state regulators from shellfish-producing states. Non-shellfish-producing states have only three representatives and the Environmental Protection Agency (EPA) and the National Marine Fisheries Service (NMFS) each have one member on the Executive Board. The FDA, which bears ultimate responsibility for ensuring the safety of shellfish shipped interstate, has only a single vote on the board.(77)

Typically, when the FDA has not concurred on an issue, it has met with the ISSC executive board in an effort to work out mutually acceptable solutions. If a resolution is not achieved, the controversial issue may be re-submitted to the next ISSC annual meeting, where it will be again debated and voted on by the attendees. That sets up an opportunity for state shellfish regulators to reject the FDA’s decision.

If a challenged proposal is passed a second time by the voting delegates, the agency can find itself in a position of having to reject once again a conference action approved by a majority of the voting states. To date, the FDA has been reluctant to engage in such a direct confrontation.

ISSC Executive Board - Voting Members
Shellfish States:      
Non-Shellfish States:   


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