The Meat We Eat: 2014 Forum on Industrial Animal Farming

The 3rd annual Food Law Society spring conference is this coming Friday, April 4, from 12:30-7:30pm.

The Meat We Eat: 2014 Forum on Industrial Animal Farming will explore the legal and policy aspects of industrialized animal farming and related effects on public health, the environment, and animal welfare. The forum will bring together a host of authorities on food law and policy and animal law to raise discussion on a number of pressing questions, including: How does industrialized animal farming affect human health, animal welfare, and the environment? How does the U.S. currently regulate animal farming, what are the barriers to reform, and what can be done to strengthen protections for consumers, animals, and nearby communities? How can we create a more transparent food system so that consumers can choose healthy, sustainably-, and humanely-raised food?

The panelists bring a wealth of experience on a variety of topics within the real of industrial animal farming regulation. The keynote speaker, Robert Martin, is the Senior Policy Advisor at the Johns Hopkins Center for a Livable Future (CLF). At CLF, Bob serves as Program Director of the Food System Policy Program. Previously, Bob worked for the Pew Charitable Trusts, where he served as a senior officer at the Pew Environmental Group and as Executive Director of the Pew Commission on Industrial Farm Animal Production.

The conference is FREE for students and $7-10 for the public.

You can register here.

Conference Schedule
12:30-1:00pm Arrival & Welcome

1:00-3:00 Session 1: Overview of Animal Farming in the U.S. and the Current Regulatory Environment

1:00-1:30 Introduction: How the American Legal System Protects Animal Food Producers, and the Consequences for Consumers and Animals

  • David Simon, Author, Meatonomics

1:30-2:30 Panel #1: Animal Welfare, Ag-Gag Laws, and the Need for Greater Transparency

  • Erica Meier, Executive Director, Compassion Over Killing
  • Paul Shapiro, Vice President, Farm Animal Protection, HSUS
  • Alexis Fox, Massachusetts State Director, HSUS (moderator)

2:30-3:00 Refreshments Break

3:00-4:00 Keynote Address

  • Robert Martin, Senior Policy Advisor, Johns Hopkins Center for a Livable Future

4:00-6:30 Session 2: The Future of Animal Farming

4:00-5:00 Panel #1: Regulating the Environmental Impacts of Animal Farming: Gaps, Overlaps, and Areas for Reform

  • Gregory Dain, Senior Assistant Regional Counsel, U.S. EPA Region 1
  • Matthew Hayek, PhD Candidate, Harvard School of Engineering and Applied Sciences
  • Erik Olson, Senior Strategic Director, Health and Food, Natural Resources Defense Council
  • Wendy Jacobs, Clinical Professor and Director, Harvard Law School Emmett Environmental Law and Policy Clinic (moderator)

5:00-5:30 Rise of the Super Bug: Antibiotic Overuse in Livestock

5:30-6:30 Panel #2: Reducing Legal Barriers, Empowering Consumers, and Creating Pathways for Sustainably- and Humanely-Raised Meat

  • Claire Benjamin, Managing Director, Food Policy Action
  • Margiana Petersen-Rockney, Founder/Organizer, Young Farmer Network
  • Nathan Rosenberg, Fink Fellow, Natural Resources Defense Council
  • Baylen Linnekin, Executive Director, Keep Food Legal (moderator)

6:30-7:30 Reception
The reception will feature Amsterdam falafel, Veggie Planet pizza, thai food, and ice cream!

FSMA Conference Part 5: International Issues and Trade Implications

[Ed. Note: On Friday, February 21, 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 is the final installment in a series of blog posts from the event; video will follow shortly.]

By Kuei-Jung Ni

Sharon Mayl, Senior Advisor for Policy, FDA Office of Foods and Veterinary Medicine – FDA’s New Import Toolkit: FSMA and Beyond

Mayl brought her first-hand experience to the conference and updated progress concerning FDA’s implementation of the FSMA mandate on food importation. She first mentioned the increasing complexity of regulating importation due to the globalization of food production and trade. Therefore, the old school method of ensuring the safety of imported food by doing border checks needs to be changed. In response to the challenges, she pointed out that FSMA shifts the paradigm by creating a multilayered safety net. FSMA Sections 301 to 309 articulate duties for relevant stakeholders that comprise manufacturer, importers, third parties, foreign regulatory bodies and FDA itself as well.

With respect to recent progress of FDA rule-making activities under FSMA, Mayl introduced two draft regulations both issued in July 2013: “Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals” and “Accreditation of Third-Party Auditors/Certification Bodies to Conduct Food Safety Audits and to Issue Certifications”. Under the FSVP regulations, importers would be required to perform certain risk-based activities to verify that food imported into the U.S. has been produced in a manner that provides the same level of public health protection as that required for domestic food producers. One of the FSMA mandates directs FDA to establish a program for the Accreditation of Third-Party Auditors for foreign food facilities. Under the regulation, FDA would recognize accreditation bodies based on certain criteria such as competency and impartiality. Then, the bodies would in turn accredit third-party auditors to, among other things, conduct food safety audits and issue certifications for foreign facilities and food under specified programs.

Finally, Mayl briefed the efforts of FDA to build up and enhance international cooperation on food safety with both international organizations, such as the Codex responsible for setting international standards, and U.S. trading partners with which harmonized and mutual recognition arrangements could be developed.

Ching-Fu Lin, Petrie-Flom Center Student Fellow, Harvard Law School – The Role of Private Ordering in the FSMA

Lin first underscored three food safety regulatory approaches that cover product-based, process-based and management-based aspects. Those approaches, he emphasized, are not mutually exclusive and can be implemented by both public and private actors. His presentation mainly focused on the pros and cons of the management-approach that, inter alia, allows private third parties to engage in regulatory tasks. In line with other tools to apply the management approach in enhancing domestic safe food production, FSMA also embraces the idea in terms of using private third parties to audit foreign suppliers. Lin predicted that foreign producers may welcome the method mainly because they find it more efficient to locate and implement the optimal regulatory designs in relation to cross-border control. Regardless the advantage of this private ordering, Lin also revealed several challenges and risks posed by the mechanism. The draft regulation on “Accreditation of Third-Party Auditors” mentioned above involves a multi-layer delegation structure. By delegating certain authority, FDA may only know obvious and serious errors, which may lead to the dilution of accountability and effectiveness. Further, although the regulation has sensed the problem of “conflicts of interest” (COI), the current device on the protection against COI seems limited to “financial” aspects. The COI defect may compromise regulatory impartiality especially when some foreign governments face potentially conflicting “dual mandates”: auditing against U.S. standards on one hand and promoting national exports on the other. The information asymmetry between third party auditors and regulator (FDA) also needs to be fixed.

Marsha Echols, Howard University School of Law – Mandatory and Voluntary Programs for Importers,

Professor Echols’s main theme is mainly concerned with the consistency of the FSMA arrangements with U.S. obligations under international trade rules. First, she introduced governing WTO rules for applying national health related measures. The 1994 General Agreement on Trade and Tariff (GATT) literally recognizes the prerogative of WTO members to protect their public health and to decide an appropriate level of protection. But, the right shall be subject to the scrutiny of a necessity standard. More specifically, it is the SPS agreement that regulates, inter alia, food safety measures adopted by WTO members. The SPS agreement requires that national measures be of science-based and risk-based character. Alternatively, members can take a precautionary measure that may departure from such a mandate as health risks involve in scientific uncertainty.

Echols then proceeded to reveal which programs embodied in Title III of FSMA are likely to create non-tariff barrier problems. With respect to the arrangement on the accreditation of third party auditors & certification bodies, many WTO members, including China, Brazil, Belize, Korea, etc., at the recent SPS meeting taking place in October 2013, raised a specific trade concern regarding whether the “outsourced” audits and certifications comply with the SPS agreement. They were concerned with if this outsourcing government responsibility would constitute a private standard.

On FSVP, Echols considered that FSMA gives FDA a great level of discretion to decide whether foreign suppliers are acting in a manner compatible with U.S. food producing standards. The discretion should be cautiously applied to avoid the inconsistency with,inter alia, the Most-Favored-Nation (MFN) principle and the risk assessment requirement of the SPS agreement.

FSMA Conference Part 4: Benefits, Challenges, and Gaps in FSMA’s Approach

[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.]

By Jeffrey Skopek

Lewis Grossman, Washington College of Law, American University – New Governance, New Challenges

Professor Grossman opened the panel by locating FSMA in the context of the “new governance” movement that has arisen in response to the limits of command and control regulation.   Some of the key features of new governance include stakeholder participation, public/private partnerships, bottom up rulemaking, consensus orientation, context-specificity, and dynamic and adaptive learning.    After discussing the benefits of new governance, he turned to a discussion of some of its limits, focusing on general ways in which it can increase the costs of regulation.   These include the costs of overseeing a regime that relies on self-regulation by parties for whom it is in their interest, as well as the costs of regulating the other parties for whom self-regulation is not in their interests.  The final part of the talk discussed some of the ways in which FSMA might increase the resources required by the FDA.  For example, because FDA inspectors are generalists who deal with both food and drugs  (there are not “food inspectors”), FSMA training will be more costly.   Further, while FSMA calls for the FDA to leverage the safety resources of state and local inspectors, this coordination must be funded, which can be expensive (e.g., the necessary information infrastructure is costly).   Finally, because the foreign third party certification system is decentralized and relies on private auditing services, it creates new possibilities for moral hazard and fraud that will require greater FDA oversight.

Kuei-Jung Ni, Petrie-Flom Center, Harvard Law School/Institute for Technology Law, National Chiao Tung University, Taiwan – FDA and Uncertain Health Risks: Regulating Veterinary Drugs in Feeding Food Animals

Professor Ni started his talk with an overview of growing concerns about how food animals are processed and produced, citing the growing number of companies that are voluntarily phasing out foods that contains antibiotics and hormones that are allowed by the FDA.  He then turned to a comparative discussion of how the US and EU have regulated hormones and antibiotics in food.   He noted that while the US has a fairly permissive approach, the EU has taken a precautionary approach.   He then discussed the pros and cons of the FDA’s approach, comparing the viewpoints of consumers, farmers, and drug makers.   The final part of this talk focused on risk analysis.   Professor Ni provided an overview of the three phases of risk analysis: risk assessment, risk management, and risk communication.  He argued that these three phases are needed to ensure that the governance of risk is science-based, responsive to competing policy concerns, and transparent.    In providing an overview of the FDA’s use of this process in other contexts (as well as the global trend), he highlighted some limits of the FDA’s approach.   He argued that risk analysis is a core principle of FSMA, and that while the FDA has started to build this type of governance regime, it needs to bring the science-finding and policy-making closer to the general public.

Stephanie Tai, University of Wisconsin School of Law – Whole Foods: The FSMA and the Challenges of Defragmenting Food Safety Regulation

Professor Tai opened with a discussion of why should we be concerned about fragmentation in policy making in this and other areas, suggesting that the problems include policy gaps, duplicative efforts, and inconsistencies.   She then turned to a discussion of the cause of fragmentation and the various actors who are involved in setting food policy, which include not only a host of federal actors (e.g., FDA, USDA, CDC, EPA), but also state and local regulators, the food industry, and consumers.  She suggested that while FSMA does not focus on enhancing coordination, it has many coordination-improving elements.    For example, it expands the FDA’s oversight authority, shifts the focus to prevention, and requires interagency collaboration in areas such as inspections, seafood safety, and food imports.   She also emphasized that it is hard to know what types of collaboration are happening behind closed doors and provided a survey of varying degrees of coordination that have been mentioned in proposed rules.   The final part of the talk focused on coordination challenges.  She highlighted examples of informational challenges (e.g., key information is still not shared by the computer systems of FDA, FSIS, and US Customs), policymaking challenges (e.g., the focus of performance measures is on integration into the budgeting process, not the policymaking process), statutory challenges (e.g., the lack of changes to USDA’s authority and mission), and structural challenges (e.g., the FSWG is not permanent and factors of political economy may provide reasons for retaining fragmentation).  She closed with a quick outline of proposals for statutory changes and non-statutory changes that could increase coordination.

FSMA Conference Part 3: Regulating Farm Production: From Zero to Sixty

[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.]

By Jason St. John, JD candidate, Harvard Law School

The third conference session, “Regulating Farm Production: From 0 to 60,” was moderated by Robert Greenwald, Director of the Center for Health Law Policy and Innovation at Harvard Law School. To make the presentations more cohesive, the presenters divided each of their fifteen-minute presentations into two seven-minute presentations. The panel discussed the FDA’s proposed Produce Safety rule under the Food Safety Modernization Act (FSMA), the rule’s focus on produce and growing of food, and the large question of whether FSMA makes our food safer.

First to speak was Dennis Stearns, Professor from Practice at the Seattle University School of Law, who gave a history of FSMA’s origins. Although the traditional story is that FSMA came from the search for more scientific food regulations, historically, major changes in food regulation happen because of a sense of crisis. The crisis that precipitated FSMA was the 2005 and 2006 E. coli outbreaks in bagged lettuce and spinach.

The trace-back after the second E. coli outbreak revealed serious problems at the field where the spinach was being grown, including feces from wild animals, contaminated water, and other hazards. However, this obscured the fact that there was not much empirical evidence on food hazards generally. The facts provided about the hazardous field provided the basis for subsequent regulation, which focused on the growing of food as opposed to processing. Stearns concluded by suggesting that the processing of the food, rather than production, carries the greatest risks.

Next to speak was Alli Condra, Clinical Fellow in the Food Law and Policy Clinic at Harvard Law School, who spoke about the details of the proposed Produce Safety rule. The rule is limited to certain farms, and only applies to some products of those farms. For example, foods that are rarely consumed raw, like potatoes, or foods that will undergo a “kill step” in further processing, like canned green beans, are not covered under the proposed rule. Farms that have annual revenues less than $25,000 are not covered. In addition, farms that have less than $500,000 in annual sales may be eligible for a qualified exemption, if more than one half of sales go to consumers or to retail units that sell directly to consumers, such as restaurants.

Margot Pollans, Resnick Program for Food Law and Policy Teaching Fellow at the UCLA School of Law, spoke next, on the problem of the mixed-type facility. Under the Produce Safety rule, the smallest amount of food processing turns a farm into a mixed-type facility, subjecting the farm to new rules. If a farm holds any food made or grown on a different farm it is treated as a mixed-type facility. This means that almost any community supported agriculture (CSA) program will result in the farm being treated as a mixed-type facility, because in CSAs farms often trade food to meet customer demand. Secondly, almost any value-added activity, such as production of jams, maple syrup, or honey, turns a farm into a mixed-type facility. This is particularly serious for small and mid-size farms as those activities can be very profitable, but due to the cost of compliance to new rules they may abandon those activities.

Fourth, Condra spoke about ways in which the rules do not reflect real-world operation of farms. For example, in estimating costs of compliance, the FDA assumed that small farms operated for only three months each year, but most small farms operate for longer than that, and so the FDA underestimated costs to small farmers. In a hypothetical case, a small farm may have $490,000 annual dairy sales, and then, due to an ancillary vegetable farm that creates another $15,000 in value, the farm is subject to the Produce Safety rule, thanks to the strict cut-off at $500,000. Condra ended by asking the most important question; how much safer will our food be due to these regulations?

Then Pollans spoke again, to discuss the poor incentives that the Produce Safety rule offers for sustainability. Specifically, she focused on two examples, fertilizers and ecosystem services. Under the proposed rule, if a farmer were to use biological soil amendments instead of synthetic fertilizer, the farmer would need to apply the fertilizer months before harvest, sometimes up to nine months before harvest. This is not feasible, and so farms are encouraged to use synthetic fertilizers that take much more energy to produce and are worse for the environment. Use of synthetic fertilizers also reduces the amount of microbes in the soil, which actually makes food less safe. Secondly, the proposed rule creates a preference for confinement of domestic animals on the farm, and a preference for shutting out wild animals. The steps farmers will need to take to isolate their farms will reduce the ecosystem services provided to the farm from the surrounding area, such as water purification.

Finally, Stearns spoke about the concerns of industrial agriculture. If anything goes wrong in a large processing plant, a major illness outbreak could occur. With non-industrial agriculture, the farms are reaching fewer consumers, and so there is a smaller chance for a significant bacterial outbreak. Stearns reminded everyone of the E. coli outbreaks in 2005 and 2006, and of the fact that the processing plants involved in that outbreak did not live up to their Hazard Analysis and Critical Control Point (HACCP) standards. However, nothing in the current proposed rule addresses the likelihood of a processing facility adhering to its HACCP standards. Lastly, FSMA gives the FDA many more responsibilities but does not increase its resources. Perhaps, Stearns concluded, the lack of resources will mean that the inspections under the Produce Safety rule will focus on industrial agriculture, and ignore small and mid-size farms.

After the presenters spoke, there was a question and answer session. One person asked if farms would simply ignore the new regulations, given the cost of compliance? Pollans responded by saying that we will likely see farmers assuming that there will not be enforcement of these regulations, but in the long term, this is a bad outcome for all involved.

One farmer made the comment that the three questions he always receives from his customers are whether there are GMOs in the food, if there are non-sterile bacteria, or if pesticides were used in the food, and the Produce Safety rule, for all it does, does not address these questions.

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.]

By Nicholson Price

After Peter Hutt’s terrific 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 shout-out to Climenko Fellow Sharon Jacobs‘ related 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!

FSMA Conference Part I: Peter Barton Hutt on the Food Safety Modernization Act in Historical Perspective

[Ed. Note: On Friday, February 21, 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.]

By Ching-Fu Lin

On February 21, a group of scholars gathered at HLS to discuss new directions for food safety and challenges to the implementation of the 2011 Food Safety Modernization Act (FSMA).  The conference featured a keynote speech delivered by Peter Barton Hutt, who is commonly recognized as the food and drug law expert in this country.

Hutt is a senior counsel at the Washington, D.C. law firm Covington & Burling.  He also served as chief counsel for the Food and Drug Administration (FDA) from 1971 to 1975. Hutt has taught a full course at HLS on food and drug law for over 20 years and has co-authored an influential casebook in this area.

Bringing in his expertise in the historical development of food law, Hutt began with what he called “still the best statute” from the English experience in 1266.  At around that time, the English Parliament codified some early regulatory statutes (assizes) that prohibited the sale of any “corrupted wine” or of any meat, fish, bread, or water that was “not wholesome for Man’s body.”  These laws continued to (with amendments and supplements) be of reference power in England until 1884.  As articulated by Hutt, it would be sufficient for the FDA to do what it needs to do even when we take the core principle “not wholesome for Man’s body” and get rid of the entire rest of the food law.

Hutt then turned to another landmark development in the history of food law.  In 1820, Frederick Accum, a German chemist working in England, published Treatise on Adulteration of Food and Culinary Poisons.  The treatise had an immediate impact worldwide and triggered the modern development of food regulatory statutes in the United States and Europe.  Indeed, the languages used in such statutes (such as prohibitions against adulteration) are reflected in the design of the 1906 and 1938 legislations in the United States.

Having given several interesting and absorbing historical nodes on the development of food law, Hutt pointed to the legislations that have formed the architecture of government regulation of food: The first national statute, the Federal Food and Drugs Act of 1906, as well as the organic statute, the 1938 Food, Drug, and Cosmetic Act (FD&C Act).  The 1938 FD&C Act has been the core statute that the FDA administers and enforces, and has been amended more than a hundred times.  According to Hutt, however, from 1938 to present, all the FDA focused on was done through “regulation and enforcement of those regulations,” since there was no new statutory authority conferred by Congress over more than 70 years.

The evolution of federal food law has come to a new front end with FSMA being signed into law by President Obama in 2011.  This “poorly drafted and poorly conceived” statute, according to Hutt, was coupled together by Congress in a hurry.  Hutt walked the audience through the new mandates for FDA, from hazard analysis and risk-based preventive controls, good manufacturing practices, mandatory recall authority, and produce safety standards, to protection against intentional adulteration, foreign supplier verification programs, and accreditation of third-party auditors and certification bodies.  Combined with the authority it already has, the FDA is now “the single most powerful government agency in the United States.”  The enormous breadth and depth of FSMA gives an impression that it was “written like a regulation, not like a statute,” and Hutt pointed to the fact that the 1938 FD&C Act covers all food with merely 4 out of 19 pages, while FSMA devotes 88 pages solely to food safety.  The burden on the FDA is massive and demanding, especially when it has to go through notice-and-comment rulemaking processes, Department of Health and Human Services (HHS), and Office of Management and Budget (OMB) with all types of impact and regulatory analyses.

Finally, Hutt asked “[w]hether the statute was necessary or even desirable?”  Based on his analysis, the FSMA was “not necessary and not desirable.”  As explained by Hutt, it was not necessary because none of those regulations couldn’t have been written after the milestone case United States v. Nova Scotia Food Products Corp., 568 F.2d 240 (2nd Cir. 1977).  The 2nd Circuit in the Nova Scotiadecision interpreted the FDA authority in a broad manner:

“The public interest will not permit invalidation simply on the basis of a lack of delegated statutory authority in this case.   A gap in public health protection should not be created in the absence of a compelling reading based upon the utter absence of any statutory authority, even read expansively.  Here we find no congressional history on the specific issue involved, and hence no impediment to the broader reading based on general purpose.  We believe, nevertheless, that it would be in the public interest for Congress to consider in the light of existing knowledge, a legislative scheme for administrative regulation of the processing of food where hazard from micro-organisms in food in its natural state may require affirmative procedures of sterilization…”

Hutt emphasized that thousands of warning letters, hundreds of seizures, and lots of criminal prosecutions have been based on the Nova Scotia decision.  Given the enormous authority given to the FDA by the decision, the agency could have done what FSMA now requires at a reasonable pace with much greater participation with the regulated industry and much greater understanding of the industry which in fact now must comply.

After having reviewed aspects of government regulation of food from ancient times to present with thrilling quality, Hutt offered his vision of the implementation of FSMA and the future of food law.  “This is going to be a serious problem of FDA completing everything it is supposed to do and then industry completing everything that it is supposed to do.”  Hutt predicts FSMA’s implementation “is not going to be done quickly.  It will be lucky if in ten years we make real progress, and it can easily be 20 or 25.  That requires that the FDA understand the complexity of what they are requiring and its impact on the regulated industry.”  The picture Hutt painted in his historical scholarship and epitomized in this keynote speech, has indeed informed the day’s panel discussions of future problems.

FLPC Highlighted as the Harvard Law Bulletin Cover Story in “Thought for Food” Article

The cover story of the Winter 2014 Harvard Law Bulletin is an article on the food law and policy work happening at Harvard Law School, highlighting the work of the Food Law and Policy Clinic, as well as the the Food Law Society and the Food Law Lab. The article describes the groundbreaking work that the Food Law and Policy Clinic has done over the past few years and emphasizes the great importance of law and policy work to improving the health and sustainability of our food system. Check it out here!

Food Law and Policy Clinic Summer 2014 Internship Opportunities

The Harvard Food Law and Policy Clinic is seeking summer interns for its 2014 summer clinic semester. We are accepting applications on a rolling basis and will review applications starting in January 2014.

The Food Law and Policy Clinic aims to increase access to healthy foods, prevent diet-related diseases such as obesity and type 2 diabetes, and assist small and sustainable farmers and producers in breaking into new commercial food markets. The Food Law and Policy Clinic is part of Harvard Law School’s Legal Services Center, located in the Jamaica Plain neighborhood of Boston.

Project areas include assisting with the development and research needs of state and local food policy councils, assessing food safety rules to inform law and policy changes that would increase economic opportunities for small local producers, analyzing and recommending ways to increase access to healthy produce for low-income individuals and those living in “food deserts,” and identifying and breaking down legal and non-legal barriers inhibiting small producers from going beyond direct farm-to-consumer sales to sell at grocery stores, restaurants, and farm to institution programs. Our work is primarily focused at the state and local level, and we have project clients and partners based in different parts of the country.

Over the summer, students will have the opportunity to conduct legal and policy research to inform a range of clinic projects, including drafting fact sheets, in-depth reports, policy recommendations, comment letters, testimonies, presentations, and legislation or regulatory guidance.

How to Apply:
The dates for the 2014 summer program have not yet been finalized, but the program will likely run from Tuesday, May 27th through Friday, August 1st for a minimum of 40 hours per week. We have some flexibility with regard to start and end dates as long as summer interns make at least an eight-week commitment.

This internship is primarily for law students, but non-law students may apply, and we make a commitment to accept several non-law students (including undergraduate students as well as students in diverse graduate degree programs) each summer.

Interested candidates should send a resume and cover letter to flpc at

More information:
For more information about the summer program, visit the Legal Services Center’s Summer Fellows Page (information is updated annually in late fall for the upcoming summer).

NOTE: This internship is unpaid, but it is SPIF-eligible for Harvard Law students. Interested candidates are urged to seek separate fellowship or grant funding, and program staff will help to support this in any way possible.

FLPC and CEP Complete Boston Food Truck Legal Toolkit

Boston is becoming a city that supports its food entrepreneurs, and students in the FLPC are playing a major role in accomplishing this feat. For the last year, students in the Harvard Food Law and Policy Clinic (FLPC) and the Harvard Community Enterprise Project of the Transactional Law Clinics (CEP) worked together to create a food truck legal toolkit to help food truck entrepreneurs navigate the variety of legal issues that accompany starting a food truck business in Boston. In early December, the FLPC and CEP completed the toolkit and presented the materials contained in the toolkit to a lively audience of inspiring food truck owners on behalf of the Mayor’s Office of Food Initiatives (OFI).

FLPC student Jason Qu ‘14 expertly clarified Boston’s food truck permitting and licensing regimes, while CEP students Veronica Sauer ’14 and Josh Wackerly ‘14 guided the attendees through the finer points of business formation, employment law, and other legal implications of starting a business. “Our challenge [with the toolkit and presentation] was to make a complex body of laws and regulations accessible for the community,” stated Qu. “We ended up creating a valuable resource for potential vendors and for the City itself.” As team members leafed through the 77 page document, which had been carefully organized to guide a potential food truck vendor through the myriad of legal processes of starting a food truck from business plan to sample contracts, Wackerly added, “when you see [the Toolkit] in print, you can definitely appreciate the amount of work the whole team put into it. It was very rewarding to be able to finish such a major project and then have the opportunity to turn around and present that product to the public and immediately witness the positive impact we’ve had on the community.”

The FLPC and CEP will continue to work with food truck entrepreneurs and OFI in the coming semesters. The CEP plans on helping food truck entrepreneurs with their specific legal questions, and the FLPC has been working to help the City reduce the barriers food truck entrepreneurs face. The partnership between the FLPC and CEP means that the work each clinic is doing will help the other do their work more effectively.

To read the toolkit, click here.