The Office of Management and Budget (OMB) Office of Information and Regulatory Affairs (OIRA) completed review of the first of the long-awaited major Department of Health and Human Services (HHS) Food and Drug Administration (FDA) Food Safety Modernization Act (FSMA) “first wave” proposed rules:
- Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food; and
- Standards for Growing, Harvesting, Packing, and Holding of Produce for Human Consumption.
The Federal Register will publish both rules on January 16; comments are due May 16.
Whether politics or quality was the cause of delay, industry and the public will have 120 days to comment on these massive proposed rules – and will need that time to comment effectively. After that, HHS must analyze and respond to the substantive comments and another round of OMB review follows. Judicial review is sure to follow and a key consideration will be the balancing of costs and benefits.
Current litigation to compel promulgation of these and other rules – likely of little impact on the timing of the rules release – may come to an ignominious end.
Background: Congress enacted FSMA at the beginning of 2011 to try to stem food-borne illnesses and to update FDA’s authority in food production. The FDA was given impossibly short deadlines to promulgate a host of rules – as in the past, these are more political pressure than legal reality because Congress imposed no direct consequences on FDA for failing to meet the deadlines. FDA submitted four rules for OMB review at the end of 2011; FDA recently submitted a fifth proposed rule dealing with third party audits. Executive and interagency review has taken a year – but OMB completed review on two major rules and FDA released copies today. FDA released also a supplemental notice – Draft Qualitative Risk Assessment of Risk of Activity/Food Combinations: Activities (Outside the Farm Definition) Conducted in a Facility Co-Located on a Farm – to gather additional data on its risk assessment, which will be part of its rulemaking decisions (NB: the Draft does not at the moment of writing link in the Notice). Industry will need to examine both the legal requirements and the law very carefully, and more interrelated regulations will be forthcoming.
Advance Release: FDA appears to have moved these documents to the Federal Register and released them very quickly after OMB completed review – for the sake of understanding, the OMB tracking website did not show OMB having completed these proposed rules prior to FDA’s release, but that actually leads to a benefit. FDA need not legally release any documents prior to the Office of the Federal Register public inspection filing (which happened today), and the supporting documents only need to be released on the docket when the rule is published. The tentative cost / benefit analyses for both rules are available from FDA, but may be altered somewhat when it is filed on Regulations.gov with the proposed rules. This is additional review time, which reviewers should welcome.
The long and short of the question of economic analysis is whether the FDA has considered (and will consider) the relevant facts, metrics, and proxies (where metrics are not available). Judicial review of that analysis is not direct, but under the Administrative Procedure Act (APA).
Good Manufacturing: The Current Good Manufacturing Practice (CGMT) proposal would update FDA’s regulations by implementing FSMA with new preventive controls provisions that apply, with exceptions, to all food facilities required to register with FDA, including food safety plans, hazard analyses, and preventive controls to mitigate identified hazards. Facilities would be required to establish:
- A written food safety plan;
- Hazard analysis;
- Preventive controls for hazards that are reasonably likely to occur;
- Corrective actions;
- Verification; and
- Associated records.
The proposed rule implements supplemental requirements to the Regulatory Flexibility Act (RFA) with three alternative caps for “very small” business: $250,000, $500,000, and $1,000,000; FDA appears to consider these as risk values. It follows that the costs associated with the rule range inversely from $319 – 475 million on that basis, but FDA admits that benefits are difficult to quantify and uses a break-even analysis that appears to follow the costs. The industry will need to analyze the rule very carefully.
Produce: The Produce proposal would implement FSMA by establishing minimum standards for the safe growing, harvesting, packing, and holding of fruits and vegetables grown for human consumption, but would not apply to fruits and vegetables that are “rarely” consumed raw, or grown for personal consumption. Commercial processes that reduce “microorganisms of public health significance” could be eligible for exemption. Definitions of exclusions and exemptions drive the complexity of the proposed rule in a number of ways, which is not surprising and may be the product of necessary compromises.
FDA ascribes $1.04 billion in benefits to this rule – largely appearing to be food borne illness avoidance, as contrasted with $630 million in direct costs. While FDA suggests a net benefit of $406 million, the theoretical benefits will not be passed on to consumers in the same way as the actual direct costs. Whether the FDA properly quantified actual costs requires a highly detailed analysis.
Wave: FDA commented today that several more FSMA proposed rules are forthcoming (currently still at OMB), including proposals that importers verify that food products grown or processed overseas are as safe as domestically produced food and accreditation standards for third party food safety audits overseas. FDA will also issue animal feed requirements – i.e. upstream control of human foods. FDA, industry, and consumers must consider whether all of these rules are properly integrated. FDA will need at least 18 months to complete the first wave of final rules, and several more years to implement the requirements.
Litigation: The Center for Food Safety sued, and, as Ricardo Carvajal at the FDA Law Blog notes, the Department of Justice (DOJ) sought dismissal or summary judgment, explaining the FDA development and OMB review process (plaintiffs must respond later this month). DOJ argued that the Center for Food Safety’s claims against OMB should be dismissed because they had no cause of action and against FDA because the claims of unlawfully withheld action were premature. In a surprise twist, DOJ argued in the alternative the actual terms of Executive Order 12,866 – that even if the 90-day window for OMB review, and the 30-day extension at the request of the Office of Information and Regulatory Affairs (OIRA) administrator were judicially enforceable, FDA had requested the extension and therefore extension was open-ended. Each rule proposed saps this litigation of a little more substance (and it had little to start), but final rules are still a long way away.