FSMA Conference Part 2: FSMA and Risk Regulation Strategy

[Ed. Note: On Friday, the Petrie-Flom Center, the Food Law and Policy Clinic (a division of the Center for Health Law and Policy Innovation), the Food Law Lab, and the Harvard Food Law Society (with support from the Top University Strategic Alliance and the Dean’s Office at Harvard Law School) co-sponsored a conference at HLS called “New Directions for Food Safety: The Food Safety Modernization Act and Beyond.”  This week, we will be sharing a series of blog posts from the event, and video will follow shortly.]

After Peter Hutt’s teriffic keynote speech, our first panel addresses the Food Safety Modernization Act and risk regulation strategies.  The speakers are Professor Jake Gersen of Harvard Law School, Director of the Food Law Lab, and Professor Michael Roberts, Founding Executive Director of UCLA Law School’s Resnick Center on Food Law and Policy.

Gersen on the Political Economy & Political Psychology of Food Safety

Jake Gersen of the Food Law Lab at Harvard Law School speaks first on the Political Economy & Political Psychology of Food Safety, retitled “Administrative Law of Food Safety.”  He begins (after a mention of Climenko Fellow Sharon Jacobsrelated article) by describing the recurring cycle of neglect, crisis, and legislation, and the challenge of getting sustained attention (especially true in food policy, but true in many other areas).  Before FSMA, there was a rash of outbreaks and quality problems, and then we got FSMA.  But the real action, Gersen says, is about regulation, not about statutes.  FSMA grants lots of power to the FDA – but they were powers that FDA probably had already.  The key of the statute is not the substance of the grants, but the way in which they’re given.

Title I focuses on prevention, requires science based standards, produce safety, safe transport rules, &c.  Title II deals with response – administrative detention.  Title III turns to imported foods, including verification of foreign suppliers, and requiring third party verification systems.  Sections I and II clarify FDA’s powers and authorities, and lowers the thresholds for action.  The statute requires that FDA implement a large number of rules, and quite quickly.

But beneath all the substance, how and why has the statute structured what FDA has to do?  A major problem is the agency problem between Congress and Agencies – the Agency might or might not do what the principal (Congress) wants – a key problem in administrative law generally.  So generally, Congress tries to restrict the administrative process, not the output.  FSMA is including different tools to manage these processes; one new tool is the use of statutory deadlines for rulemaking.  These used to be quite rare, but have rapidly increased recently, and there are several in FSMA – 7 by 2012.  And all of the deadlines were missed by FDA.

Gersen then talks about litigation, Food Safety v. Hamburg, where FDA was challenged on missing its deadlines under § 706(1) of the Administrative Procedure Act.  It’s usually very hard to compel agencies to act, but deadlines are an area where this sometimes works, and in this case the government lost.  But the question is, what’s the remedy?  The agency already missed the deadline.  If food safety is the goal, either delay or bad regulations are bad.  (One interesting theory is that the deadline is use-it-or-lose-it, but that theory hasn’t gotten much traction).  In this case, the court tried to negotiate a settlement, but eventually ordered injunctive relief setting new deadlines for the FDA.

So what’s going on?  Congress legislates and demands immediate action, but it’s too quick for the agency.  Why does that happen?  One idea is that Congress is trying to tinker with internal agency priorities.  It could also be an easier way to manage the agency (small “a”) problem – a cheap and easy monitoring strategy.

But Gersen’s preferred view (sans evidence) is that the deadlines are trying to manage the relationship between line agencies and OIRA/OMB (which reviews agency rules).  Recently, OIRA and OMB have increased review time by a lot.  Now, if agency rules are bad, OIRA might have to take a longer time; but we could also imagine that if good rules are submitted, deadlines could reduce the time of OIRA review; this would be Congress injecting itself into OIRA/FDA dynamics.  This is especially possible with respect to cost-benefit analysis.  As an example, Gersen points out to the sanitary transportation rules, where it’s hard to figure out the overall costs and benefits.

And he closes, happily, with a quotation from the FDA’s centennial anthem.

Roberts on the Regulation of Food Fraud Under FSMA: A Triggering of Obligations

Next up is Professor Michael Roberts, Executive Director of UCLA’s Resnick Center on Food Law and Policy.  He’ll be talking about the problem of food fraud, which is both old and new.  He’s fielded more media inquiries about food fraud than about any other issues.  Food fraud is a major global problem, including different kinds of meat, seafood, honey, olive oil, maple syrup, whisk(e)y, champagne, and many other types of food.  Food fraud is a complex global problem; food and money flow through complex international networks.  He talks about honey in particular, which he, at least, no longer buys off the grocery shelf.

Roberts goes on to define some basic terms.  Food fraud is really economic adulteration, from FDCA § 402(b).  There’s a requirement of intent, so this is typically called economically motivated adulteration (EMA), typically to try to increase the apparent value of the product or reduce its cost.  Other forms of food fraud include counterfeiting or bioterrorism.

Historically, food fraud has been around a long time, and is the earliest form of food regulation, including wine, meat, and bread in Greece, Rome, and throughout the Middle Ages.  It was mostly based on commerce, though it was also somewhat linked to safety and health.  In the Middle Ages, bakers found to be adding adulterants to their bread were pilloried.  Food fraud has been challenging in the US because sometime it’s hard to know what a food’s identity is, as was front-and-center in the vicious peanut-butter-definition wars of the mid-20th century.

There’s no statutory definition of food fraud and economic adulteration, but it falls within the general “adulteration” provisions.  There’s no comprehensive regulatory plan, and standard-making is dead outside state government; at the federal level, there’s no real coordination between agencies, especially FDA and Commerce.

The food safety and nutrition link was shockingly illustrated in the Chinese melamine scandal, which resulted in 6 deaths and 54 hospitalizations.  In a 2009 FDA hearing, FDA made a link to safety, but it was an attenuated link; most fraud has few safety implications (though a culture of fraud might have some implications).

In FSMA § 106, there’s protection against intentional adulteration, but it’s limited to terrorism, and excludes economically motivated adulteration, which will instead be included in Hazard Analysis and Risk-Based Controls.  It may be that this will place the burden of avoiding food fraud on facilities, but there’s a real question as to whether this is likely to be effective or a priority.

The interesting other step in the area is the entry of the US Pharmacopoeia (mostly involved with drug standards) has started creating standards for a few types of food, and has developed a food fraud database.  This might potentially trigger obligations for companies to test, based on the existence of the database, which could put them on notice; in any case, it will be interesting to observe.

Beyond FSMA, there are other technologically driven tools, including import alerts by FDA, self-governance, private standards, litigation (especially class action), and FTC rules against “unfair” and “deceptive” trade practices (though FTC regulates advertising, not labeling, and this still seems mostly a labeling problem).

Roberts closes with some normative issues – how does this play into the dichotomy between localized and industrialized food, social justice, consumer norms including transparency and the right-to-know, and into the global food system in general.


How can small business determine which supplies might be fraudulent, to include those in hazard analyses?  Professor Roberts replies that ignorance is an unfortunate corporate strategy.  Knowledge of the problem has recently become more pronounced, though, and FSMA creates more traceability requirements.  Those, combined with class-action litigation, have created spurs to industry to try to track inputs.  Knowing the most-likely-fraudulent products, and being able to trace them, becomes a big part of managing food production, even though it’s quite complex.

Cindy Kruger, in-house counsel at PepsiCo, notes that there are areas where you can predict, but others which are unpredictable.  How do you determine what a company can reasonably do, and should regulations address economically motivated fraud that’s hard to figure out?  Roberts replies that technology can help.  In the past, it was very hard for a company to determining food fraud.  Now, with USP and other databases, the landscape has changed; the information on what is fraudulent is much more readily available.  Do those databases trigger obligations, whether social, FSMA-based, or otherwise?  It doesn’t seem like there’s an obligation to test every incoming lot, but risk assessment based on available information seems like it’s probably necessary (though still hard).

For Prof. Roberts, is there evidence that local food is less likely adulterated?  Roberts replies no – local food is just as susceptible to food fraud – including farmers’ markets!  The containment is much easier to manage on a local level than on a global market.  At least in California, local fraud has been decreased (at least in farmers’ markets).  But the local/industrial dichotomy is really being fed by this issue.

For Prof. Gersen, how would deadlines make OIRA move faster, or would the agency just bypass OIRA?  Gersen replies that it’s hard to know how this will work.  OIRA says it takes statutory deadlines seriously, but if you say that to agency folks, they find it hilarious.  But deadlines are statutory requirements, and should overrule the executive action requiring OIRA review.

And that’s Panel 1!

W. Nicholson Price

W. Nicholson Price

Nicholson Price is an Assistant Professor of Law at the University of Michigan Law School. Previously, he taught law at the University of New Hampshire. He holds a PhD in Biological Sciences and a JD, both from Columbia, and an AB from Harvard. He clerked for Judge Carlos T. Bea on the Ninth Circuit, and was then appointed as an Academic Fellow at the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard. Nicholson teaches patents and health law and studies life science innovation, including big data and artificial intelligence in medicine. He recommends reading Bujold, Jemisin, and Older. His work has appeared in Nature, Science, Nature Biotechnology, the Michigan Law Review, and elsewhere. Nicholson is cofounder of Regulation and Innovation in the Biosciences, co-chair of the Junior IP Scholars Association, and a Core Partner at the University of Copenhagen’s Center for Advanced Studies in Biomedical Innovation Law.

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