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
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.
|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
- 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
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 states 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 states shellfish products and not state public-health agencies.
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