Inside the FDA: The Realities of Rulemaking

The Food Safety Modernization Act was signed into law on January 4, 2011. As currently scheduled (by court order), the first of the major seven final rules will be published by August 30, 2015.

Given this four-year spread, and the fact that FDA has not met the Congressionally scheduled deadlines for most of the steps to date, one has to wonder why it takes so long to publish rules and why it’s so difficult to meet the due dates. Is it just to be expected of the slow grinding of wheels of our federal government and the bureaucracy that goes along with it?

Yes. And no.

While the wheels of bureaucracy do tend to grind slowly, the heart of the issue lies more with the number of wheels through which the rules must grind and the importance of allowing time for the public (including industry) to read proposed rules, think about the impact, and provide comment. To explain, let’s walk through the steps of federal rulemaking:
 

Rulemaking Steps

1. An optional first step for FDA is the issuance of an Advance Notice of Proposed Rulemaking (ANPRM) to seek information prior to publishing a proposed rule. Once FDA has the information it needs, it would then determine if it should issue a proposed rule, then, if so, write and publish it for review and comment.
2. FDA issues a proposed rule (also called Notice of Proposed Rulemaking/NPRM) and publishes it in the Federal Register for public review and comment. If a proposed rule could impact international trade, FDA also sends notice to the World Trade Organization.
3. Once the comment period is completed (generally within 30 to 90 days—but as seen with the FSMA-related rules, the comment period can be much longer), FDA reviews the comments and determines if revisions should be made based on these. If revisions are extensive, FDA may re-issue a proposed rule (as with FSMA’s Preventive Controls and Produce Safety rules), or it can move on to the issuing of a final rule which, again, is published in the Federal Register. According to mandate, the preamble to the final rule includes discussion of significant comments received. 
4. Although a rule is published as final, compliance is not always immediately required. The amount of time before a rule goes into effect can vary, most often based on the complexity of the rule and expected difficulties of compliance. In addition, a final rule may provide accommodations for small and very small businesses.
5. Because the final rule does not always address every specific issue the industry may face, FDA often issues guidance on the rule, which represents its current thinking on the topic. Guidance documents are not legally binding, but are intended to describe FDA’s interpretation of or policy on a regulatory issue. It is wise to review the documents, however, as they often discuss issues of design, production, labeling, promotion, manufacturing, and testing of regulated products; relate to the processing, content, and evaluation or approval of submissions; and discuss inspection and enforcement policies.
    

Seem simple? Perhaps … except that these official rulemaking steps fail to include the internal Agency pre-rulemaking steps needed to develop the proposed rule—and every iteration between it and the final rule:
 

Internal Agency Steps.

A rule has numerous “unofficial” internal drafting, approval, and revision steps through which it must proceed before even making it to step 1 (or 2) in the previuosly listed Rulemaking Steps:

1. A draft of the proposed rule is written by the staff at FDA—which may include those from any of the Agency’s centers (e.g., Center for Food Safety and Applied Nutrition/CFSAN), the Office of Regulatory Affairs, or other agency responsible for drafting the rule. It is circulated internally until agreement is reached.
2. That final draft is then taken up a level, to FDA (or USDA) leadership and legal staff, for review, at which point it may be returned to the drafters for revision, if needed—which it usually is. This may go many rounds.
3. Once approved by the Agency, it must go up to the department level for review, in the case of FDA, this is the Department of Health and Human Services (HHS). Again, it is often returned back down the ranks for revisions—as many times as needed.
4. Next step is review by the Office of Management and Budget (OMB), which is an office of the President, who evaluate it for economic impact, impact on trade, and alignment with other government rules. (For example, how does the FDA Produce Safety rule intersect with the USDA organic rule?)
5. At any point along this chain, questions can be raised that take the draft back to step 1 for more research, analyses, data, and rewriting—all before the public has a chance to see it for the first time. Sometimes before FDA gets too far into step 1, however, it may hold a series of public meetings to explain where it is heading with the rule and to seek initial public input.
    

Although shown as five steps, any back and forth conveyance for revisions and agreement can add innumerable steps—and time. Additionally, every iteration of the rule, proposed through final, must go through each step—with no specified interim deadlines. If you’ve ever had a paper sit on a boss’s desk awaiting approval, knowing there is little you can do to speed it along (and which of us have not experienced this?), you know the frustration that FDA officials feel when asked, “When will the rules be published?” and they can only shrug their shoulders and say, “I don’t really know.”

In all likelihood, a particular FDA official doesn’t even know where the rule is in the above steps, nor can we. There is no public tracker telling where the rule is sitting, thus there’s no accountability for how long each review and revision takes. So, too often, FDA is blamed when the rule actually may be sitting on a desk at HHS or OMB.

We’ve seen this in the past with FSMA, and when you have a series of rules as massive and integrated as these—the “most sweeping reform of our food safety laws in more than 70 years,” the process becomes even more complex and convoluted. Keeping that in mind, it will be interesting to see if, or how closely, our federal agencies are able to meet the court-mandated deadlines for FSMA’s final rules:

• August 30, 2015 – Preventive Controls rules, both the human food and the animal food rules.
• October 31, 2015 – Produce Safety, Foreign Supplier Verification Program, and Accreditation of Third-party Auditors.
• March 31, 2016 – Sanitary Transport.
• May 31, 2016 – Intentional Adulteration/Food Defense.
   

With the re-proposals of Preventive Controls and Produce Safety so significantly delayed this year—and having no idea of whose desk or desks these rules sat on or how many times they flowed up and down the chain—the meeting of the final deadlines seems questionable at best.

But, there really are no consequences when rules take a long time to move forward, and I have speculated what may happen if FDA fails to meet the court-mandated deadlines for FSMA. I have to conclude that I expect nothing will happen if those deadlines are missed. However, I do think it very likely that the bulk of these key new rules will be made final before the administration changes. A change of administration would certainly add major delays and could even stall the rules for a long time. Remember the “Egg Rule” which took about 12 years to pass as a final rule?

Despite our frustrations with the process, it is important, especially with the complexities of FSMA, that there be time for public comment and that these rules don’t get pushed out too fast, because once they are final, it is very hard to make changes. Additionally, despite the government’s delays and missed deadlines, it is important that food companies not delay, but be preparing now. Because once the final rules and compliance dates are published, your deadlines are unlikely to change.