Which of the following is something the Food and Drug ...

[Jkov05]

Which of the following is something the Food and Drug Administration devotes part of its annual budget to:
 a. food sanitation and processing b. studying biological products
  c. studying veterinary products
  d. studying the quality of marketed drugs
  e. all of the other specific choices are correct

Question 2

Rulemaking. The Occupational Safety and Health Administration (OSHA) is part of the U.S. Department of Labor. OSHA issued a Directive under which each employer in selected industries was to be inspected unless it adopted a Comprehensive Compliance Program (CCP)a safety and health program designed to meet standards that in some respects ex-ceeded those otherwise required by law. The Chamber of Commerce of the United States ob-jected to the Directive and filed a petition for review with the U.S. Court of Appeals for the Dis-trict of Columbia Circuit. The Chamber claimed, in part, that OSHA did not use proper rulemak-ing procedures in issuing the Directive. OSHA argued that it was not required to follow those procedures because the Directive itself was a rule of procedure. OSHA claimed that the rule did not alter the rights or interests of parties, although it may alter the manner in which the par-ties present themselves or their viewpoints to the agency. What are the steps of the most commonly used rulemaking procedure? Which steps are missing in this case? In whose favor should the court rule and why?

[iman]

Answer to Question 1

e

Answer to Question 2

Rulemaking
The U.S. Court of Appeals for the District of Columbia Circuit held that the Administrative Procedure Act (APA) required the Occupational Safety and Health Administration (OSHA) to conduct a notice and comment rulemaking proceeding before issuing the Directive. Under the APA, an agency seeking to promulgate a rule must first provide the public with notice of, and an opportunity to comment upon, a proposed version of it. Because OSHA did not conduct this proceeding, the court vacated the Directive. The court explained that to the extent that participation in the Comprehensive Compliance Program requires more than adherence to existing law, the Directive imposes upon employers more than the incidental inconveniences of complying with an enforcement scheme; it has a substantive component. The court acknowledged that OSHA could reissue the Directive after observing the required procedures.