Food safety – what could be more important? The FDA Food Safety and Modernization Act (FSMA), signed into law on January 4, 2011, requires a significant regulatory shift by the Food and Drug Administration (FDA). FSMA imposed numerous deadlines for FDA to adopt regulations and those deadlines have passed into history without rules. Given those facts, a number of advocacy blogs and the press have complained recently that rules are “stuck” at the Office of Management and Budget (OMB) Office of Information and Regulatory Affairs (OIRA). Demanding action, two organizations filed suit to compel the FDA to publish the rules. Is there something to this issue of legislative deadlines? Or is the holdup another example of bad analysis leading to a potentially worse result? Is the suit improvident?
FSMA: In the waning days of the 111th Congress, FSMA finally passed, and makes major expansions of FDA’s authority over the food pipeline, from producers, foreign and domestic, through registration and inspection, to seizure. The FDA has described the FSMA as “the most sweeping reform of our food safety laws in more than 70 years.” The degree of change: massive; the substance: complicated; made more so by Congressional specifications in and out of the Code of Federal Regulations, specific requirements for substantive consideration within regulations; multiple procedural additions to the regulatory process;, and highly specific regulatory requirements sometimes dictating agency expertise rather than delegating to the FDA’s expertise. The substance of many “science-based” and risk-driven decisions will employ a multitude more specialists than the administrative law issues relating to compelling agency action.
Regulations: Four draft proposed rules pending at OMB involve very large economic effects, affect multiple agencies and other policy priorities, and create novel policy issues. OMB’s website leads to the Fall 2011 Unified Agenda links:
- Hazard Analysis and Risk-Based Preventive Controls;
- Foreign Supplier Verification Program;
- Current Good Manufacturing Practice and Hazard Analysis and Risk-Benefit Preventive Controls for Food for Animals; and
- Produce Safety Regulation.
FDA and the Department of Health and Human Services (HHS) submitted all of the draft proposed rules to OMB in November and December, 2011, and time alone is a good indicator that OMB, the White House, and the agencies have problems with the drafts. Problems may become clear only when the FDA publishes the rules and the FDA and OMB release the submitted drafts.
Some concerns of other agencies are obvious, though perhaps not obvious to the FDA:
- Small Business Administration (SBA): the Hazard Analysis proposal as an exception to their universal size standards;
- Department of State (DOS): the Foreign Supplier rule effect on substantial foreign relations of the United States; or
- Department of Homeland Security (DHS): risk analysis, both foreign and domestic terrorism, and the interplay of their own responsibilities.
The Department of Agriculture is likely concerned with every word of these proposed rules. Each proposed rule impacts more than $100 million on the economy, each appears to have a significant impact on a substantial number of small businesses, and each appears to require additional reporting and recordkeeping – implicating the core values and analyses underlying Executive Order 12866, the Regulatory Flexibility Act (RFA), and the Paperwork Reduction Act (PRA).
Quality Analysis: Without inside information, suspicious immediately turns to the issue of whether the FDA has provided quality analysis supporting what are clearly costly rules, whether FDA has considered adequately less costly or burdensome alternatives, and whether other agencies can figure out how these large and complex rules will affect them. These analyses are probably the most significant reasons why any rule is delayed in Executive and interagency review.
The alternative to quality analysis and review is ill-considered, singularly bureaucratic, egocentric rules that, in the end, cost more and benefit less. That result is anathema to any Administration. Experience suggests that the greatest political follies are the result of ill-considered judgment. Delay is thus not surprising.
Complaint: The Center for Food Safety and Center for Environmental Health v. Hamburg complaint filed in the United States District Court for the Northern District of California fails to understand any of these issues, and has the shrillness of a true believer, alleging that FDA has missed seven deadlines for rulemaking under the FSMA:
FDA’s failure to implement FSMA’s critical food safety regulations by their statutory deadlines is an abdication of the agency’s fundamental responsibilities. Moreover, the agency’s unlawful delay is putting millions of lives at risk from contracting foodborne illnesses. This lawsuit seeks to require FDA to immediately promulgate the FSMA regulations required by law and enforce self-executing sections of FSMA even without finalized regulations.
Such an argument is hardly convincing and appears more tuned to supporters than any court. Problems abound in the complaint.
The requirement for regulations suspending registrations provides a good example:
The Secretary shall promulgate regulations to implement this subsection. The Secretary may promulgate such regulations on an interim final basis.
The “deadlines” in the FSMA are bald assertions of temporal requirements that do not appear to have any consequences:
Not later than 18 months after the date of enactment of the FDA Food Safety Modernization Act, the Secretary shall promulgate regulations ….
While this may inform a judicial decision on whether the Secretary has acted reasonable, it does not do more. Some are more specific:
Not later than 9 months after the date of enactment of this Act, the Secretary of Health and Human Services (referred to in this subsection as the “Secretary”) shall publish a notice of proposed rulemaking in the Federal Register to promulgate regulations with respect to–
“Not later than 9 months after the close of the comment period for the proposed rulemaking under paragraph (1), the Secretary shall adopt final rules with respect to ….
The goals may be laudable, and the specifications discrete, but the provisions are not compelling for several reasons:
- FSMA permits some use of interim final rules, but does not expressly except those rules from the requirements of the Administrative Procedure Act (APA) and the rule of construction requiring such express exception.
- The existence of some permissive interim final rule authorities excludes the interim final rule from use where Congress has not permitted its use.
- Even the suggestion of use of interim final rule is permissive, vesting the Secretary and FDA with discretion, not a ministerial duty.
- The “deadlines” have no express consequences and the courts have required more than generalized requisitions amid the plethora of conflicting requirements lack of appropriations sufficient to fulfill them all.
The complaint at least correctly recites that Executive Order 12866 provides for the centralized review of regulations by OMB to ensure that regulations are consistent with applicable law and the President’s priorities, and that decisions made by one agency do not conflict with policies and actions taken or planned by another agency (and all things are waivable).
At bottom, the complaint asks the court to substitute its judgment for that of the Administration, and ignores binding precedent in the Ninth Circuit.
Veronica Knapp at Hogan Lovells is quite correct:
In general, courts are reluctant to find unreasonable agency delay because they are hesitant to question agency priority setting and allocation of scarce resources. Where successful, lawsuits alleging unreasonable delay by FDA generally have involved delays much longer than the present alleged delay in FSMA implementation.
The complaint may serve some political purpose in bringing a small amount of political pressure to bear on the Administration, but, as a question of administrative law, it is ill-advised and premature. The better course is methodical analysis, not a rush to judgment.