834 



virtual dissolution of their industry in the face of proposed and need- 

 less severe regulations by the Food and Drug Administration, These 

 FDA regulations will give added power to the Federal Government, 

 impinge on the rights of individual States, place a financial burden on 

 the taxpayer, and yet provide very little, if any, extra safety factors 

 in the shellfish industry. 



Under the Administrative Procedure Act of 1946, the FDA has 

 proposed a formalized rule structure which would replace the existing 

 voluntary Federal-State industry program for tlie sanitary control of 

 oysters, clams, and mussels. Thus, a 50-year voluntary program which 

 has worked well may be replaced by the iron hand of Federal regula- 

 tion. 



This 50-year program, the national shellfish sanitation program — 

 NSSP — has been a cooperative effort by Federal and State Govern- 

 ments to supervise and regulate the shellfish industry for the benefit 

 of the consumer. The FDA has not provided the public with an ade- 

 quate explanation as to why a successful program like the NSSP 

 must be effectively liquidated by the Federal Government's arbitrary 

 extension of FDA authority in'this field. The elements of the NSSP 

 since 1925 have been effective, and they include the review of a State's 

 general administrative procedures for the processing activities of a 

 State's shellfish program, sanitary sui-vey to assure that shellfish are 

 not harvested in polluted waters, the elements of controlled purifica- 

 tion, and packing conditions. As I have stated, this has been a highly 

 successful program, and in my State of Maryland, it has been effective 

 in assuring shellfish quality without jeopardizing the industry with 

 over-costly regulatory requirements. The Maryland program has never 

 received a single, substantive complaint about its operations or pro- 

 cedures. The program has on its own and without Federal prompting, 

 closed down a number of shellfish beds if endangered conditions are 

 thought to exist. 



Following a recent storm which caused a fresh water flow into the 

 Chesapeake Bay, posing a possible hazard to shellfish stock, the State 

 program closed down oystering in the affected portions of the Chesa- 

 peake Bay. The State has conducted a regular series of inspections 

 of plants in line with the Maryland Health Department's continuing 

 sanitation program. The State has the power to seize endangered shell- 

 fish stock, and it has used this power for protection of both the indus- 

 try and the consuming public. 



Yet, the FDA would discount this unqualified record of responsible 

 and effective monitoring by the States and impose a series of regula- 

 tions which the President's Council on Wage and Price Stability 

 called excessive. In the Council's October 21. 1975 comments before 

 the FDA concerning the proposed regulations, it offered in part : 



The Council believes that FDA's study of additional costs (required by its 

 new regulations if promulgated) is based on untested assumptions rather than 

 an analysis of the industry. The study assumes that the proposed regulations 

 would increase fixed costs within the industry by no more than 50 percent and 

 variable costs by no more than 25 percent. The sum of these costs is $24.4 million, 

 according to FDA's analysis. 



The Council went on to say that the costs as they would be absorbed 

 by individual firms has not been examined by FDA, and that as it 



