The Procedural Requirements- 553

1. The Procedural Requirements-553 The publication of a proposed rule What might happen to a rule if the agency fails either to provide public notice or An opportunity to comment

2. A rule can be remanded • The rule can be invalidated • The agency can be further ordered

3. The Challenge • Structure the rulemaking process • Proposal should be significantly informative • But further comment not a waste of time • How might an agency solicit information?

4. Gathering Comments • Hold public meetings • Convene advisory committee(s) • Publish advance NPRM—sometimes required by statute • Publish regulatory agendas and RIA’s • Make rulemaking dockets available for public review

5. Gathering Comments (more) • Fund public participation • Use outside consultants

6. Representative Cases • United Steelworkers v. Marshall • Unsuccessful challenge to OSHA’s rulemaking on airborne lead • Involved allegations OSHA’s use of consultants violated a ban on ex parte contacts • Court treated consultants as de facto staff during post-comment period

7. United States v. Nova Scotia Food • US sought to enjoin processing of smoked whitefish that violated previously adopted FDA rule • Rule’s objective was to minimize potentially fatal bacterial growth in processed fish • Processor’s defense for injunction: This rule is unlawful

8. Nova Scotia (cont’d) • FDA wished to address the objective by requiring the heating of the fish at high temperatures • The time and temp of the processing could vary with the salinity of the solution in which the fish was brined • FDA adopted its challenged rule through informal rulemaking

9. Nova Scotia (cont’d) • National Fisheries Institute and Bureau of Commercial Fisheries were not happy with the outcome • Both objected—wanted a species by species approach • FDA rejected the request—thought information not available • FDA thought immediate need to protect public • Thought standard the safest to combat botulism

10. Nova Scotia • So FDA IGNORES the scientific possibilities that may have worked • FDA (also) fails to discuss the merits of the claims as to commercial feasibility • Defendant challenged the rulemaking as procedurally inadequate

11. Nova Scotia (still continued) • Record to skimpy, • FDA failed to disclose its sources of factual information AND • Agency’s statement of basis and purpose was inadequate • What guidance is provided in the APA?

12. 701(a) • Did this confer the authority to issue regulations? • Did the FDA have the authority to make binding rules under 701(a)?

13. Hearings in Informal Rulemaking • Does the reviewing court have the power to order an agency to adopt hybrid rulemaking procedures?

14. Vermont Yankee • In the absence of “constitutional constraints or extremely compelling circumstances” a court MAY NOT impose rulemaking procedures on an agency beyond those set out in Section 553 of the APA

15. Vermont Yankee • Remember Florida East Coast? • It is up to Congress or the agencies to require more than notice and comment procedures • To the extent that an agency gives more process, it is within the agency’s discretion to do so, not the Court’s • Message to the D.C. Circuit freewheeling court: Stop this!!!!!

16. Vermont Yankee • Any exceptions? The extremely compelling circumstances exception • But isn’t nuclear safety the epitome of an “extremely compelling circumstance?” • NRC adopts a grid approach

17. What does the NRC do? • Held hearings, but not of the formal, on-the-record variety • Allowed public inspection of agency data • Allowed opportunities to present opposing position • Allowed representation by counsel • Incorporation of public comments into a reviewable record • And public inspection of the hearing transcript and • An opportunity to file post hearing comments

18. Disallowed • Cross-examination and • Discovery among the participants

19. Supreme Court says: • NRC had complied fully with all explicitly mandated APA procedures, and thus; • A court could not overturn its informal rule for procedural inadequacy • APA, per Vermont Yankee, mandates the minimum procedures required of agencies, and, at the same time, the maximum that courts may mandate.