1018 



132 



the submission to the Congress of a report of a Shellfish Advisory 

 Committee established by the bill, except where the Secretary of Com- 

 merce determines that an emergency has occurred. 



Should such a provision be enacted, a serious public health danger 

 could result. In the first place, delegating authority to the Secretary 

 of Commerce in an area where the Secretary of Department of Health, 

 Education, and Welfare is clearly the official capable of determining 

 health risks, would seem to be inadvisable. By prohibiting the Food 

 and Drug Administration from "promulgating" regulations, this pro- 

 vision would not onlv limit the effective date of Food and Drug Ad- 

 ministration regulations, but might also be interpreted as limiting 

 their ability to conduct field hearings and other administrative pro- 

 ceedings during the period regulations are proposed. In view of the 

 length of time necessary to promulgate regulations this could delay 

 the effective date of final regulations for one to two years after the 

 June 1977 date in the bill. 



Second, if a public health emergency exists, the Food and Drug 

 Administration cannot issue regulations on its own initiative to pro- 

 tect the public health, and so is prohibited from carrying out its re- 

 sponsibilities mandated by the Federal Food, Drug and Cosmetic Act 

 and the Public Health Service Act. 



Third, limiting regulations to emergencies may come too late since 

 action must be taken before an emergency to adequately protect the 

 public. 



Finally, I believe it is inappropriate for the Congress to react on 

 a case-bv-case basis on such regulations. 



The Committee has received repeated assurances from the Food 

 and Drug Administration which confirm that the procedure already 

 in effect and governed bv the application of the Federal Food, Drug 

 and Cosmetic Act and the Public Health Service Act, will allow for 

 considerable input from industry and State and local governmental 

 authorities in this vital area of shellfish safety. 



It is important to note that the Food and Drug Administration 

 published a notice in the Federal Register stating that their revised 

 proposed regulations will not be published until mid-1976 and in view 

 of the length of regulation promulgation procedures for hearings 

 and revisions, final regulations cannot be published until March and 

 take effect in April, 1977 at the earliest date. Since the bill limits 

 promulgation until June 30, 1977, I believe there is no need for § 310 

 (d) and that the issue is now moot in view of Food and Drug Admin- 

 istration assurances. 



While I share and support the need for effective and thoughtful 

 approaches to the management of our coastal zones and protection 

 of our marine resources, it is my strong belief that § 310(d) as pro- 

 posed does not liave a place in this legislation and is against the public 

 interest. 



Paul G. Rogers, 

 Member of Congress. 



