Thursday, June 23, 2016

My interest in food law knows no boundaries

Some of you may think that in my posts I wander way outside the bounds of food law, others might not even realize I do. So rather than give a legal analysis of some current issue, I’m taking a moment to discuss the term.

Law students, and consequently law schools, are increasingly interested in food law. Courses, clinics, student groups and  entire programs are popping up across the country. As these programs expand, it’s important to clarify the meaning and purpose of food law.

Food law refers to the body of laws and regulations that govern the manufacturing, distribution and sale of food. It is primarily about regulatory law and regulatory compliance, with some  advertising law and litigation related to food. A venn diagram of traditional food law might look like something like this:

food law venn 6.jpg

If you want to study and learn the nuances of this niche area of regulatory law and litigation, there are a number of longstanding forums that address the topic. Some of these are the Food and Drug Law Institute and several American Bar Association sections including the Antitrust Section’s Agriculture and Food Committee, the Section of Science & Technology Law’s Food, Cosmetics and Nutraceuticals Committee, and the Section of Litigation’s annual food law meeting. Food law tracks at conferences presented by industry groups such as the Grocery Manufacturers Association and the Institute for Food Technologists are also good places.

Of course, Michigan State University is a leader in food law with our online International Food Law Internet Certificate Program and online Master of Laws (LL.M.) or Master of Jurisprudence (M.J.) in Global Food Law. We also have our upcoming Food Law Current Issues Seminar, where I hope to meet many new and interesting colleagues!

So why are so many students interested in food law? I think it's because there’s a trending interest in food right now, especially among millennials who make up the bulk of students currently enrolled in law school classes.

I’m certainly part of this trend. I’m a millennial with a J.D., and I helped found a food law society at my law school. With the J.D., I can research and analyze the legislation, regulations, guidance and case law that constitute the legal reasoning justifying particular legal outcomes.

However, my interest in food law extends beyond just the legal outcomes. I am interested in how social and political contexts influence our laws concerning food as well as agricultural production and food access. I also care about how the legal outcomes differentially affect farmers, food manufacturers, consumers and related stakeholders and their consequent impacts on the economy, the environment, public health, and individuals’ and communities well being.

Some scholars use the phrase “food law and policy” to conceptually capture the broader array of issues that intersect with food law. This is akin to an ever increasing venn diagram absorbing overlapping legal and policy domains.  Somewhat like this:
food law and policy venn v5.jpg

I would bet that, like me, this is why many others are interested in food law, whether they’re lawyers or not.

However, as my director Neal Fortin often reminds me, because an issue intersects with food does not make it food law. At the Michigan State University Institute for Food Laws & Regulations (IFLR) and College of Law Global Food Law Program (GFLP), food law is used in its traditional meaning to describe regulatory law that applies to food and the related areas of product liability and advertising law. Therefore, the core courses in our programs (available here and here) focus on U.S., international and transnational regulatory law of food.

That said, working for the IFLR and GFLP isn’t going to stop me from exploring all the agri-food systems policy issues I’m interested in. Because I have an interdisciplinary Ph.D. I like to draw on sociology, geography and political science, but I also consider many, many other disciplines important to understanding the operations and impacts of local, regional, and global agri-food systems.

My conceptual framework of the relevant disciplines thus looks like this:

agrifood law and policy venn v5.jpg
The only conceptual utility of this is to communicate how complex and messy the study of agri-food systems policy is if you want to incorporate every conceivable overlapping domain. It is a task that is far beyond any one scholar or discipline. Pragmatically, research must focus on one feature of agri-food systems while also considering the related domains and impacts.

So while you’ll see me blogging about whatever agri-food systems policy-related legal issues I find interesting, students of food law should note that I am often venturing outside the realm of traditional food law.

Meanwhile, if you want to learn some cutting-edge food law and get the chance to meet me in person (perhaps to explain why I’m doing it all wrong) you should register for the Food Law Current Issues Seminar and come visit East Lansing July 12-14.

- Michaela Oldfield

Tuesday, June 14, 2016

Of zombies and criminals

By Michaela Oldfield

As the recall for products linked to sunflower seeds potentially contaminated with Listeria grows, I think this is a good time to talk about recalls. I feel like this is a bug I’m hearing more and more about in the news, and have sometimes wondered if it's just me being more attentive to food safety stories, if it's the media being more opportunistic about reporting food safety stories, if there’s really more outbreaks happening, or if it's that we’re getting better at detecting outbreaks. It turns out that a lot of it is that food scientists and regulators are getting really good at detecting outbreaks.

Listeria only affects a small percentage of the population, and has very long incubation periods (up to 60 days), and harbors and grows in cool, moist environments. Outbreaks may consist of a number of sporadic illnesses over a long period of time, and it can be difficult to do the traceback to figure out what the common food is that all the victims have eaten. For instance, the outbreak that Blue Bell is being investigated for involved 10 illnesses and three deaths over the course of four years.

This make it difficult to detect when a real outbreak connected to a particular food is happening or when there is a just a random collection of illnesses happening coincidentally at the same time.

At a talk at the Food Safety Summit, Dr. Wiedmann of Cornell University[1] demonstrated this issue using data from an outbreak in 1997 to 1999. The slide below shows that if you can fingerprint the strains, you can see which are all the same (and therefore possibly from the same food) and which are all different and so presumably not from the same food source.

Listeria is an extreme example, but similar characteristics of most foodborne illnesses make them difficult to detect. Given the variety of foods that people eat in any given day and that once an outbreak is detected most of the food has been eaten or thrown away, it is very difficult to identify the common cause of illnesses. Further, it historically made it even more difficult to hold companies accountable because of the legal standards for liability.

But today, the cost of whole genome sequencing (WGS) is plummeting, which allows significantly more accurate identification of which strain of a microbe caused a particular individual’s illness. Once listeria is positively connected to a food, regulators can go back and sequence the genome of strains isolated from past listeria patients and connect them back to the specific outbreak.

Bill Marler brought this up in his lecture at MSU’s Creating A Food Safety Culture Executive Education. He described this as like a hand reaching out from the grave to hold a company liable.

So back to my original question: Is the uptick in Listeria outbreaks due to a change in me, the media, food manufacturing, or detection? WGS is going to make it progressively easier to detect and trace back illnesses. The following slide, from Dr. Wiedmann, shows that environmental sampling demonstrates that the presence of listeria in food manufacturing environments is going down, but detected outbreaks are going up.

This pattern of increasing illness detections is not going to be limited to Listeria. Whole genome sequencing was implemented for Listeria in 2013, but the CDC is expanding its use in other foodborne pathogens.

For most consumers, this might mean it seems like there’s more outbreaks happening and that the food system seems less safe. However, it's actually a good thing for consumers. WGS, and increased surveillance and traceback, is going to make it easier to conclusively connect a person’s illness to a food product and thus meet the legal standard for holding the company liable. So consumers who are injured are more likely to be compensated, while bad actors are more likely to be detected and held accountable.

This poses a major risk for any company that doesn’t make food safety a top operational priority. Another speaker at the MSU Food Safety Executive Training, Dave Theno, called this risk the one metric you bet your company on every day.

However, WGS won’t just catch bad actors that wantonly disregard public health. The Food, Drug, and Cosmetic Act prohibits the introduction into commerce of any food that is adulterated or misbranded, 21 U.S.C. § 331.

Usually, to be convicted of a crime requires some kind of criminal state of mind, such as intentionally or knowingly doing the act that is prohibited.

Not so for the FDCA.

21 U.S.C. § 331(1) states “Any person who violates a provision of section 331 of this title shall be imprisoned for not more than one year or fined not more than $1,000, or both.”

This penalty provision requires no knowledge of the fact that you are introducing adulterated food into commerce. Simply by introducing adulterated food you can be convicted of a misdemeanor.

The Jensen Brothers, who were responsible for the 2011 listeriosis outbreak linked to cantaloupe, were convicted of misdemeanors, though they had absolutely no intent or even knowledge that they were releasing contaminated food into the market.

If you are convicted and introduce an adulterated or misbranded product, or do it “with the intent to defraud or mislead,” you can be convicted of a felony. 21 U.S.C. § 331(2). 

Did you know Dole and Blue Bell are under criminal investigations for their recent Listeria outbreaks? These investigations have to do with what the companies knew about the conditions at their plants and what they did (or chose not do) about it.

Furthermore, under the Park Doctrine, any corporate officer who had "authority with respect to the conditions that formed the basis of the alleged violations" can be held liable, United States v. Park, 421 U.S. 658, 674 (1975).

Notably, one of the ways a food can become adulterated is if it was manufactured or held under unsanitary conditions. 21 U.S.C. § 342(a)(4). So the food doesn’t have to actually be contaminated, just produced in a facility where it could become contaminated. For instance, if there was, say, Listeria hanging out in a floor drain or some floor mats that might occasionally contaminate a batch of ice cream or salad.

So under Park, a corporate officer can be held liable if  he had authority to deal with a situation, such as food manufactured or held under unsanitary conditions. 421 U.S. at 674. 

Want to know more about this kind of liability? Dr. David Acheson, the former Associate Commissioner for Foods at FDA, will be talking about how to avoid criminal investigations at the upcoming MSU Food Law Current Issues Seminar, July 12-14 in East Lansing, MI. Of course, the best way to avoid a criminal investigation is to prevent any illnesses in the first place. We have quite a few speakers and panels that will cover how to do that as well.

There's still a few spots left for anyone -- lawyer or otherwise -- to learn about how great it is to be a food lawyer. Maybe you'll even find out you want to be one.

[1] I asked Dr. Wiedmann to share his slides with me, but everything I write here is my understanding of the science. So if anything is wrong, please don’t impute it to Dr. Wiedmann. 

Monday, June 06, 2016

Is the FDA Keeping Pace with the Current Health Adversities Through Labeling?

By Melissa Card

The marathon is coming to an end as manufacturers cross the finish line with their new products. General Mills, Kellogg, Mars, and McDonald’s have been racing to reformulate their products to remove partially hydrogenated oils (PHOs) – the primary dietary source of industrially produced trans fatty acids (IP-TFA). Manufacturers were forced to join the race by the Food and Drug Administration because Americans continue to fuel themselves on foods laden with trans fatty acids.

The race began with a slow jog in 2003, when the FDA published a final rule in the Federal Register requiring trans fatty acids to be declared on the Nutrition Facts label of conventional foods and dietary supplements. The FDA’s labeling requirement led to two behavioral changes: consumers decreased their consumption of trans fatty acids and the industry reformulated its products to reduce or remove PHOs.

Even though the labeling requirement caused positive behavioral changes, trans fatty acids were still permitted in processed foods, were still feasted upon by consumers, and were still causing adverse health consequences. Due to these consequences and others, in November 2013, the FDA made a preliminary determination that PHOs were not “generally recognized as safe” (GRAS) for use in food. The FDA released its final determination that PHOs were not GRAS for use in food in 2015.

The required labeling of trans fatty acids and final determination that the use of PHOs were not GRAS in the use of food were not arbitrary decisions by the FDA. These decisions were based on scientific evidence. In 2002, for example, the Institute of Medicine recommended that trans fatty acids needed to be replaced with alternative sources of fat, and reduced in the American diet. These recommendations were based on the finding that the consumption of trans fatty acid increases one’s risk of coronary heart disease. In 2004, FDA Food Advisory Committee, Nutrition Subcommittee agreed that reducing consumers’ trans fatty acid intake was necessary. Similar scientific evidence was established by (1) the Dietary Guidelines Advisory Committee in 2005; (2) the U.S. Department of Health and Human Services in 2005; (3) the World Health Organization in 2009; and (4) Food and Agriculture Organization in 2010.

Due to the available scientific evidence and the findings of expert scientific panels establishing the health risks associated with the consumption of trans fat, the FDA concluded that there was no longer a consensus among qualified experts that partially hydrogenated oils were generally recognized as safe for any use in human food.

While consumers are still concerned about the adverse health effects of trans fatty acids, the new craze concerns added sugars. Fad diets are eliminating added sugars from meal plans, celebrities are swearing off added sugars, and manufacturers are sprinting to reformulate their products without added sugars. The reduction of added sugars from the diet is more than a craze. Just last month the FDA published a final rule in the Federal Register requiring that added sugars be declared in the Nutrition Facts label of conventional foods and dietary supplements. It seems that the FDA is starting the slow jog to reduce (or eliminate) added sugars from the American diet, just as it has done with trans fatty acids.

Hopefully, the declaration of added sugars and the percent daily value for added sugars on the Nutrition Facts label will convince consumers to reduce their added sugar intake and manufacturers to reformulate their products. Despite the positive changes that are likely to occur, trans fatty acids exemplify that labeling is not a “be all end all” solution. Therefore, will the FDA release a preliminary determination that added sugars are not generally recognized as safe for use in food?

The Sugar Association is likely to distinguish added sugars from the trans fatty acids, arguing that the FDA has no scientific justification for releasing a preliminary determination that added sugars are not generally recognized as safe for use in food. But, the Sugar Association is wrong. Analogous to the trans fatty acid race, health organizations have established some scientific evidence:
  • The Journal of the American Medical Association has found that added sugar consumption increases the risks of dying from cardiovascular disease.
  • The American Heart Association has found that added sugar consumption increases the risks of developing obesity and diabetes.
  • The American Institute for Cancer Research has found that added sugar consumption increases the risks of having certain types of cancers.

In addition, many health organizations have stated that added sugar consumption must be reduced.  

One can easily answer “yes” to the question of whether the FDA is keeping pace with the current health adversities through labeling. With the requirement of the declaration of added sugars and the percent daily value for added sugars on the Nutrition Facts label behavioral changes will occur with consumers and the industry.

The question that remains is whether the FDA’s release of a preliminary determination that added sugars (or at the very least fructose) are not generally recognized as safe for use in food will be a 100-meter dash or another 10-year marathon?

Melissa Card is Adjunct Professor and Associate Director of the Institute for Food Laws & Regulations at Michigan State University.

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