#BELHP2014 Behavioral Economics, Law, and Health Policy Conference: Keynote, Cass Sunstein

[Ed. Note: On Friday, May 2 and Saturday, May 3, 2014, the Petrie-Flom Center hosted its 2014 annual conference: “Behavioral Economics, Law, and Health Policy.”  This is the first installment in our series of live blog posts from the event; video will be available later in the summer on our website.]

Today’s sessions opened with a keynote address from Cass Sunstein, Robert Walmsley University Professor at Harvard. Sunstein is also the founder and director of the Program on Behavioral Economics and Public Policy at Harvard Law School.

Sunstein addressed a wide variety of in-depth issues in his talk on “Choosing Not to Choose.”

In the beginning of the talk, he provided three objections to the argument that active choice-making is a muscle and should not be interfered with. First, people often choose not to choose, and forcing them to do active choice-making is “part of the family” instead of an alternative to default rules. It is also a form of libertarian paternalism. Second, in thinking about active choosing and default rules, we should bear in mind a basic evaluation framework that helps to minimize sum of decision costs and error costs. Third, sometimes it is best to choose not to choose. In many case we should honor people’s choice not to choose when it minimizes decision costs and reduces the magnitude and number of errors (especially when people are forced to choose, they may go in the direction that is wrong or not in their best interest).

Sunstein went on to three examples on the ground to orient the audience:

  • Case 1: A private company is deciding among three options: (1) automatic enrollment in insurance unless opt out, (2) opt in to insurance, or (3) as condition for starting work, forced choice of whether to be insured and which insurance plan (active choosing).
  • Case 2: A utility company is deciding between a green default, a grey default for its consumers, or to force them to decide which source they prefer (no service until you decide).
  • Case 3: A doctor is dealing with patient facing difficult medical situations, and could decide among: (1) present array of options, (2) default (“if it were me I would/most patients do”) with opt out.

All three cases have an institution considering requiring active choice instead of default rules. Sunstein played with the meaning of “requiring” in order to unsettle the opposition and to suggest that it is often illusory. He briefly reviewed claims such as that doctors and policymakers are prone to error as well (behavioral biases), that governments lack knowledge as well, that behavioral findings can compound the problem, or that even when people are likely to err, their autonomy to choose should be respected. He argued that the distinction between active choosing and default is rather illusory because people often want to choose not to choose (for reasons like limited bandwidth, find choosing unpleasant, don’t want to take responsibility or regret, or know they are biased). When people don’t want to choose and are forced to do active choosing, we forbid their choice not to choose. “Choice requiring paternalism is not an oxymoron.”

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The Future of “Country of Origin” Labeling Regulations

By Ching-Fu Lin

The U.S. Court of Appeals for the District Columbia Circuit recently ruled against the meat industry’s challenge to stop the United States Department of Agriculture’s (USDA) implementation of the amended Country of Origin Labeling (COOL) rules.  The current COOL regulations (amended in May 2013) require retailers to identify several types of information on beef, pork, and poultry products that were previously not required.  It now requires labeling of the country where the animals were born, raised, and slaughtered along with the prohibition of the commingling of meat muscle cuts from different origins.

The old and less stringent version of the COOL regulations was published in 2009 by the USDA’s Agricultural Marketing Service (AMS) based on the 2008 Farm Bill (Food, Conservation, and Energy Act of 2008) amending the Agricultural Marketing Act of 1946.  In the same year, Canada and Mexico brought a case in front of the World Trade Organization (WTO) Dispute Settlement Body (DSB), arguing that the old COOL requirements violated relevant WTO rules.  The WTO DSB found that the old COOL requirements were inconsistent with the US’s obligations under Article 2.1 (national treatment principle) of the WTO Agreement on Technical Barriers to Trade (TBT Agreement) as well as Article X:3(a) (uniform, impartial, and reasonable administration) of the General Agreement on Tariffs and Trade (GATT 1994).

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China Issues 2014-2020 Development Blueprint on Food and Nutrition

By Ching-Fu Lin

China’s highest executive organ, the State Council, put out the Food and Nutrition Development Outline 2014-2020 (the Outline) in February of 2014.  The Outline was jointly drafted by China’s Ministry of Agriculture (MOA) and National Health and Family Planning Commission.  The Ministry of Finance, Ministry of Education, Ministry of Commerce, Ministry of Science and Technology, and National Development and Reform Commission also participated in its development.  Based on a review of China’s growth and problems in food and nutrition, the Outline sets a seven-year plan that highlights basic policy objectives.  The areas of focus are food supply systems, nutrition intake and balance (especially amongst population sub-groups), regulatory and surveillance mechanisms, industry development, research, and education.

The Outline lays out its “guiding strategy” that the government should regard the effective supply of food, balanced nutritional profile, and production-consumption coordination as its chief missions.  To execute these missions, the government identifies certain key products (quality agricultural products, convenient processed foods, and dairy and soy foods), key areas (poor, rural, and newly urbanized areas), and key population groups (the pregnant women and nursing mothers, infants and children, and the elderly) as starting points to promote better food and nutrition development patterns.  Such points are further elaborated in the document.  The guiding strategy ultimately aims to improve public health and a well-off society.

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FDA’s Draft Methodological Approach to Identifying High-Risk Foods

By Ching-Fu Lin

Last month, the Food and Drug Administration (FDA) published a draft methodological approach for designating high-risk foods (HRFs) as required by section 204(d)(2) of the Food Safety Modernization Act (FSMA).  HRFs identified by the FDA are subject to additional record-keeping requirements, and more frequent foreign inspections and mandatory third-party certification requirements.  The FDA is seeking comments, scientific data, and information from stakeholders to revise this draft HRF approach and to create a preliminary HRF list.

Among many available risk tools (e.g. qualitative, semi-quantitative, and quantitative methods), a semi-quantitative risk ranking model has been selected by the FDA as the most appropriate methodology for the HRF list.  There are many reasons for choosing this model, including the fact that – as explained by the FDA – it is “data-driven and comprehensive, using explicit criteria related to public health risk; … adaptive to a variety of hazards; and … flexible to consider different foods or categories of food.”

Based on the draft semi-quantitative risk ranking model, the FDA is considering and evaluating a set of seven criteria that match the factors specified in section 204(d)(2)(A) of FSMA: Read More

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

[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 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.

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TOMORROW: “New Directions in Food Safety” conference at Harvard Law School

This one-day conference will bring together experts in food law and regulation to discuss a range of issues including food safety, agriculture, risk regulation strategy, and international issues.

Speakers are:

  • Keynote: Peter Barton Hutt, Harvard Law School/Covington & Burling
  • Alli Condra, Food Law and Policy Clinic, Harvard Law School
  • Marsha Echols, Howard University School of Law
  • Jacob E. Gersen, Food Law Lab, Harvard Law School
  • Lewis Grossman, Washington College of Law, American University
  • Ching-Fu Lin, Petrie-Flom Center, Harvard Law School
  • Sharon Mayl, Senior Advisor for Policy, FDA Office of Foods and Veterinary Medicine
  • Kuei-Jung Ni, Petrie-Flom Center, Harvard Law School/Institute for Technology Law, National Chiao Tung University, Taiwan
  • Margot Pollans, Resnick Food Law and Policy Program, UCLA School of Law
  • Michael Roberts, Resnick Food Law and Policy Program, UCLA School of Law
  • Denis Stearns, Seattle University School of Law
  • Stephanie Tai, University of Wisconsin School of Law

For the full agenda, including paper titles, please visit our website.

This event is free and open to the public, but space is limited and registration is required. To register, please click here.

For questions contact petrie-flom@law.harvard.edu or 617-496-4662.

Sponsored by 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.

2/21: “New Directions for Food Safety” — conference at Harvard Law School

This one-day conference will bring together experts in food law and regulation to discuss a range of issues including food safety, agriculture, risk regulation strategy, and international issues.

Speakers are:

  • Keynote: Peter Barton Hutt, Harvard Law School/Covington & Burling
  • Alli Condra, Food Law and Policy Clinic, Harvard Law School
  • Marsha Echols, Howard University School of Law
  • Jacob E. Gersen, Food Law Lab, Harvard Law School
  • Lewis Grossman, Washington College of Law, American University
  • Ching-Fu Lin, Petrie-Flom Center, Harvard Law School
  • Sharon Mayl, Senior Advisor for Policy, FDA Office of Foods and Veterinary Medicine
  • Kuei-Jung Ni, Petrie-Flom Center, Harvard Law School/Institute for Technology Law, National Chiao Tung University, Taiwan
  • Margot Pollans, Resnick Food Law and Policy Program, UCLA School of Law
  • Michael Roberts, Resnick Food Law and Policy Program, UCLA School of Law
  • Denis Stearns, Seattle University School of Law
  • Stephanie Tai, University of Wisconsin School of Law

For the full agenda, including paper titles, please visit our website.

This event is free and open to the public, but space is limited and registration is required. To register, please click here.

For questions contact petrie-flom@law.harvard.edu or 617-496-4662.

Sponsored by 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.

 

The Impact of FSMA Import Rules on Domestic Suppliers

By Ching-Fu Lin

The Food and Drug Administration’s (FDA) proposed rule on Accreditation of Third Party Auditors to implement the Food Safety Modernization Act (FSMA) has given rise to many questions on both domestic and international levels.  The proposed rule is intended to establish a program for recognition of accreditation bodies and accreditation of third-party auditors to provide the FDA with a more efficient tool to regulate imported food products.  In this regard, §307 of the FSMA and its implementing rule are generally seen as necessary to assist the FDA in regulating food imported from foreign jurisdictions, as the FDA is currently administratively and financially unable to ensure import safety on its own.

Again, the proposed rule on Accreditation of Third-Party Auditors is designed to cope with import food safety, and works in an inter-related manner to another proposed rule for Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals.  However, many have expressed concerns about the possible trend toward  such “import” rules – which embrace private regulatory participation – becoming de facto “domestic” rules.  Although the legal effects of private certification against FDA standards of domestic products are yet to be clarified, the FDA indicated that such an introduction of rules to the domestic sphere may be desirable in the proposed rule on Accreditation of Third-Party Auditors:

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REGISTER NOW: “New Directions for Food Safety” conference at Harvard Law School

This conference will bring together scholars to discuss a range of issues related to the Food Safety and Modernization Act, including FSMA and risk regulation strategy; regulating farm production; benefits, challenges, and gaps in FSMA’s approach; and international issues and trade implications.

Speakers include:

  • KEYNOTE: Peter Barton Hutt, Harvard Law School/Covington & Burling – The Food Safety Modernization Act in Historical Perspective

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Challenges to Third-Party Food Safety Audits and Certification

By Ching-Fu Lin

About a month ago, Jensen Farms pleaded guilty to federal criminal charges for introducing adulterated food into the nation’s food supply via interstate commerce.  In 2011, cantaloupes produced by Jensen Farms resulted in a listeria outbreak that spread across 28 states, killed 33 people, and sickened hundreds.  The now bankrupt and out of business owners—brothers Eric and Ryan Jensen—are to be sentenced in January 2014.

The Jensens took responsibility for one of the deadliest food safety outbreaks in the United States, but they also turned around to sue Primus Labs, a food safety audit firm.  The brothers allege that Primus Labs acted negligently, breached its contractual obligations, and engaged in deceptive trade practices in performing third-party audits on the farmlands and packing house.  Merely weeks before the outbreak, Primus Labs sent one of its subcontractors (Bio Food Safety) to Jensen Farms to perform a third-party audit.  After the audit, Bio Food Safety gave Jensen Farms a “superior” rating with an almost impeccable score of 96 out of 100, which was later found by the Food and Drug Administration (FDA) to be “seriously deficient in its inspection and findings.”  As claimed by the Jensens, Bio Food Safety failed to observe several practices that were in violation of Primus Labs’ standards and relevant FDA guidelines or to inform them of any microbiological risk.  Despite these deficiencies, Jensen Farms cantaloupes were “Primus Certified” and entered into the retail market.

The Jensen Farms case raises questions on the credibility of third-party audits and certifications in the area of food safety.

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