United States v. Decosters Decision

Yesterday, July 6, the Eighth Circuit upheld the United States v. DeCoster three-month prison sentences and $100,000 fines for Austin “Jack” DeCoster and Peter DeCoster, respectively the owner and chief operating officer of Quality Egg, LLC. Over the years, several salmonellosis foodborne illness outbreaks were associated with eggs from DeCoster farms. In a 2010 outbreak that resulted in the present case, nearly 56,000 were sickened.

In a 2–1 decision, the appeals panel ruled that even though the DeCosters did not know that the eggs they shipped had Salmonella, they “are liable for negligently failing to prevent the salmonella outbreak” and that jail time is appropriate. The Food, Drug, and Cosmetic Act “punishes neglect where the law requires care.” See United States v. Park, 421 U.S. at 671 (the eponymous case for the Park doctrine, also known as the “responsible corporate officer” doctrine).

This case was notable for the number of amici on behalf of the DeCosters: The Washington Legal Foundation, Cato Institute, Chamber of Commerce of the United States, Pharmaceutical Research and Manufacturers of America, and the National Association of Manufacturers. Recently there has been a concerted push for abolishing strict liability from all federal law, including the Park doctrine of the Food, Drug, and Cosmetic Act.

No matter how you feel about mens rea, the DeCosters are poor poster children for eliminating Park doctrine strict liability under the Food, Drug, and Cosmetic Act. Strategically, a proposal to eliminate strict liability that applies to the Park doctrine stakes out a weak position. It defends wrongdoers whose negligence causes tens of thousands of serious illnesses. It defends wrongdoers whose negligence causes the deaths among the most defenseless, children and the elderly. Be prepare to answer the grieving mother who lost a child or the widow or daughter who lost her father, who was a decorated WWII veteran or decorated Korean War veteran.

>> Hurry, registration is limited!

Food Law Current Issues Seminar

Michigan State University        East Lansing, Michigan

July 12-14, 2016

The MSU Food Law Current Issues Seminar provides practical education on current food legal and regulatory issues. The seminar covers cutting edge issues in international, transnational, and national food law and policy including FDA and E.U. food ingredient and safety regulations, U.S. advertising and labelling law, and globalized supply chain liabilities and management strategies. Speakers from the legal, food industry, and academic professions will present practical food law information and case studies.

This seminar is for a global audience in food regulatory work, including industry regulatory affairs, quality assurance, government officials, the legal community, advertising and marketing professionals, academics, and policy makers.

The course is offered in a collegial, intimate learning environment. Time will be allowed for questions and answers as well as informal discussions over lunch and coffee. In addition to the educational sessions, social activities are planned on a voluntary basis.

The cost for the course is $1345 until May 15th; after May 15th registration will be $1545.

For more information, click here

or

Register Online

The Faculty

P. Vincent Hegarty PhD, Founding Director/Professor Emeritus, MSU, Institute for Food Laws and Regulation

Elizabeth H. Dickinson, JD, Chief Counsel to the FDA [invited]

Leslie Bourquin, PhD, Professor of Food Science and Human Nutrition, Michigan State University

Stuart Pape, JD, Shareholder, Polsinelli

Charles Breen, Senior Consultant, EAS Consulting Group

Ken Odza, JD, Corporate Counsel, Food Safety, Kellogg Company

Robert Prevendar, MPH, Managing Director, Global Supply Chain Food Safety, NSF International

Daniel Dwyer, JD, Partner, Kleinfeld, Kaplan and Becker, LLP

Tim Slawinski, Emerging Issues Specialist, Michigan Department of Agriculture and Rural Development

Howard Sklamberg JD, Deputy Commissioner for Global Regulatory Operations and Policy, FDA [invited]

Francesco Planchenstainer, JD, PhD, Senior Regulatory & Food Law Specialist at Mead Johnson Nutrition

Robert Hollingworth, PhD, Emeritus Professor of Entomology, Michigan State University

Bill Marler, JD, Managing Partner, Marler Clark

Hannah Chanoine, JD, Counsel, O’Melveny & Myers; Lecturer-in-Law, Columbia University School of Law

Jennifer McEntire, PhD, VP, Science Operations, Grocery Manufacturers Association

John Spink, PhD, Assistant Professor and Director of the Food Fraud Initiative, Michigan State University

Shawn Stevens, JD, Food Industry Counsel LLC

Adam Ekonomon, JD, Director and Assistant General Counsel, Marketing and Regulatory, The J. M. Smucker Company

Mary Engle, JD, Associate Director for Advertising Practices at Federal Trade Commission

Kimberly Wingfeld, Director, Science Policy, Labeling and Standards, Grocery Manufacturers Association

Latasha Robinson, Branch Chief of Labeling and Dietary Supplement Compliance, FDA [invited]

Steve Steinborn, JD, Hogan Lovells, U.S., LLP

 Learn more about IFLR at: www.IFLR.msu.edu 

FDA Extending Menu Labeling Compliance Date

FDA is extending the compliance date for its menu labeling rule by one year. Restaurants and other establishments covered by the menu labeling rule will have until December 1, 2016 to post calories and other information on their menus and menu boards, provide full written nutrition information in-store, and come into compliance with the rule’s other requirements.

The menu and vending machine labeling requirements are available here.

Oral Arguments in Challenge to VT Law on GE Labeling

The U.S. Court of Appeals for the Second Circuit will hear oral argument Thursday, October 8, in Grocery Manufacturers Assoc. v. Sorrell, on an appeal of the federal district court’s denial of a preliminary injunction. The injunction request was to delay effect of the new Vermont law. The law will require labeling of most foods that contain genetically-engineered ingredients. Unless enjoined, the law will take effect next July.

Neal Fortin's most recent publication, The U.S. Food Safety Modernization Act: Implications in Transnational Governance of Food Safety, Food System Sustainability, and the Tension with Free Trade, is available in the Duke Environmental Law & Policy Forum current issue.

Forget GMOs, Label DNA!

A survey by economist Jayson Lusk at the Department of Agricultural Economics at Oklahoma State University found, unsurprisingly, that Americans remain skeptical of GMOs: 82 percent surveyed supported mandatory labeling of foods made with ingredients grown from GMOs. However, an astonishing 80 percent of those Americans supported mandatory labeling of foods containing DNA! (The difference between 82 and and 80 percent in this survey is statistically indistinguishable.)

My colleague, Ilya Somin, wrote up an interesting article about this, "Over 80 percent of Americans support “mandatory labels on foods containing DNA”. His humorous take on DNA labeling follows:

FDA to update guidance on food ingredient safety assessment

The U.S. Food and Drug Administration (FDA) has begun the process of updating its current guidance on food ingredient safety assessment, commonly referred to as the Redbook, and is requesting input from the public. The agency is interested in developing a framework that incorporates the assessment of ingredients present in various products regulated by the FDA’s Center for Food Safety and Applied Nutrition (CFSAN). Examples include food additives, food contact substances, ingredients that are generally regarded as safe (GRAS), new plant varieties, dietary supplements and new dietary ingredients, cosmetic ingredients, as well as unavoidable chemical contaminants other than microbial pathogens.

The FDA is particularly interested in comments on:

• Which parts of the Redbook should be updated, and how the FDA should prioritize updates.
• The scope of the revised guidance, and what other guidance documents could be addressed or incorporated by reference.
• New assays, test methods, and endpoints that could be useful for safety assessment, with justifications for why and how these proposed new methods should be considered.
• Key studies and considerations for study interpretation for each of the regulatory categories of food and cosmetic ingredients and chemical contaminants overseen by CFSAN.
• Ways to make the guidance more useful to stakeholders.
• Ways to make its processes and criteria for safety assessment clearer to stakeholders.

The comment period ends on May 11, 2015.

Press release

Consumer Reports Touts Dearies not Theories in Favor of Mandatory GMO Labeling

Sherlock Holmes in the 2009 movie stated, “It is a huge mistake to theorize before one has data. Inevitably one begins to twist facts to suit to theories instead of theories to suit facts.” When one forms theories before having the data, one grows attached to one’s “dearies” and increases risk of confirmation bias.

The March 2015 issue of Consumer Reports magazine features an article with an ostensible intent to help consumers “sift through the facts” about the purported health and environmental effects of genetically modified organism (GMOs). Unfortunately, the article cites theories that lack supporting facts and in the end only adds to the fog surrounding modern biotechnology.

For instance, Consumers Union opines that, “the jury is still out on the health impact of GMOs.” The jury of public opinion may be out, but the overwhelming conclusion of scientific experts is clear: Every major scientific body in the United States and around the world has reviewed independent research and concluded that genetically engineered crops and food are as safe as those developed by conventional methods.

Consumers Union claims that animal studies “have suggested that GMOs might cause damage to the immune system, liver, and kidneys,” but they fail to support their allegation with a single study. I endeavor to read every study that is touted as showing GMO risk. I have yet to find a single one that indicates a risk different than with conventionally bred varieties.

The column describes recent attempts by U.S. states to require GMO labeling and repeats a misleading mantra, "shoppers have a right to know what’s in their food.” GMO labeling reveals nothing about what is in a food. Genetic engineering is a breeding method not an end product. Rather, to the degree that people believe GMO labeling reveals something about what is in their food, GMO labeling is misleading.

The article did point out an interesting twist to the labeling debate. The food companies strongly opposed to mandatory GMO labeling also produce non-GMO products. Consumer Reports seems so surprised that companies would produce what people are willing to pay for that they missed the importance of the fact — people already have the choice to buy GMO or non-GMO. Consumers can buy organic (which cannot contain GMOs) or products with voluntary “Non-GMO" labeling.

The article concludes that mandatory GMO labeling schemes would add “less than a penny a day” to most grocery bills. This conclusion is based on an assumption that food producers would simply add “GMO” to existing labels with no change in product formulation. This is a naïve assumption considering the expected negative consumer reaction. Many misperceive mandatory GMO labeling as validation of theories about risk. When it is assumed many products will be reformulated to avoid GMO ingredients, other studies put the estimated cost increase for a family of four at $400 to $800 per year.

The Consumer Reports' economic analysis is also superficial because it ignores how the details of a GMO labeling law would affect the costs. For example, a GMO-labeling exemption for organically produced foods could magnify the increase in food costs to consumers. In typical recently proposed GMO-labeling laws, organic food would be exempt from GMO labeling if it contains inadvertent GMO content. Whereas with nonorganic, non-GMO labeled products, companies would face legal repercussions if testing reveals misbranding even if due to inadvertent content. This would likely drive up the cost of non-GMO labeled food because food companies would choose more expensive organic ingredients to avoid potential liabilities (Van Eenennaam). Oh, and this would also benefit organic growers, who are major sponsors of these laws. But I am sure that is just a coincidence.

New EU Legislation Would Let European Union Member States Ban a Gene-Engineered Crop

It violates the spirit of the World Trade Organization agreements.

It upends the status of science as the neutral arbiter.

Nonetheless, I am optimistic about the new legislation in the European Union that will give member states the power to ban gene-engineered crops (GMOs) for various social and policy reasons. The legislation was approved by the European Parliament is expected to be approved by the European Council.

Up to now, GMOs are banned only for health and safety concerns. Under the future rules even after the European Food Safety Authority has found a GMO safe, members states may ban the GMO in their territory, “based on a wide range of reasons such as: environmental or agricultural policy objectives, town and country planning, land use, socio-economic impacts, avoidance of GMO presence in other products, or public policy, to name a few.”

I am optimistic this law will help clean up a polluted scientific communication environment. No longer will it be necessary to distort the facts and magnify the risks to justify a ban.

Perhaps we are already seeing some refreshing honesty as a result. The Scottish government has recently asserted its opposition to planting of GMOs. The reasons:
1. “[T]here is no evidence of significant demand for GM products by Scottish consumers.”
2. "To grow GM crops in Scotland would damage our clean and green brand.”

You have to respect that. No disingenuous framing. No wildly implausible theories. Just preference and protection of marketing.

My article on partially hydrogenated oils, GRAS, and Pigs in a Poke

In the current issue of Food Technology I have an article on partially hydrogenated oils, GRAS, and pigs in a poke. You can read the whole article here.

Is the Russian Ban on US and EU Food Imports a Violation of the WTO Agreements?

I doubt the US would ever challenge the Russian ban on United States and European Union food imports as a violation of the World Trade Organization (WTO) agreements because the ban will likely hurt Russia more than the US.

Russia might argue the ban was based on a security interest that was permissible under the Sanitary and Phytosanitary Agreement exceptions. Regardless of the defense, a complaint almost certainly would be tied up in dispute resolution for a long time. In short, this is far beyond what WTO was designed to handle. 

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Vermont bill requiring GMO labeling

English: Vermont State House, December 2005. (Photo credit: Wikipedia)

The Vermont General Assembly passed a bill that will require most (but not all) foods produced with genetic engineering to be labeled as such. The law, which would go into effect July 1, 2016, is the first in the nation to require labeling products of genetic engineering. GMO labeling laws passed recently in Connecticut and Maine are contingent on a variety of other factors being in place, including more than four surrounding states enacting similar requirements.

The Vermont bill includes a provision for a special fund for legal defense. Litigation seems likely and may challenge the law on a number of grounds, especially violation the First Amendment guarantees for free speech and as interference with interstate commerce in violation of the Commerce Clause. A weaker challenge may be made based on field pre-emption by federal law. Another weaker challenge could come under the Establishment Clause because the Vermont bill includes a purpose of informing those with religious beliefs against GMOs.

Michigan Bill for Tail to Wag the Dog — Prohibition on Federal Food Safety Law Enforcement

English: First page of Constitution of the United States Česky: První strana originálu Ústavy Spojených států amerických Español: La página primera de la Constitución de los Estados Unidos de América (Photo credit: Wikipedia)

Michigan Representatives McMillin, Hooker, and Lund have introduced Michigan House Bill 5336, which would prohibit enforcement of federal law regulating food that was “produced in and remains in” Michigan. Violations of the state law would be punishable by fines or imprisonment or both.

Potential law school exam question: “Discuss the errors in understanding of the United States Constitution reflected in this bill? In particular, explain the scope of the Commerce Clause. Discuss the tail wagging the dog.”

GRAS: Generally Recognized As Secret?

The Natural Resources Defense Council (NRDC) issued a report that raises more questions about the US regulatory system for food additive. The report says the GRAS exemption from food additive review by FDA — “generally recognized as safe” — that intended for common food ingredients “has been stretched so most new chemicals pass through it: the loophole has swallowed the law.”

NRDC believes that “Generally Recognized as Secret” rather than “Generally Recognized as Safe” is a better name for the GRAS loophole. A chemical cannot be “generally recognized as safe” if its identity, chemical composition, and safety determination are not publicly disclosed. If the FDA does not know the identity of these chemicals and does not have documentation showing that they are safe to use in food, it cannot do its job.

A PDF of the report is available here.

A summary of the report follows:

FDA Reopens Comment Period on "Evaporated Cane Juice"

The Food and Drug Administration is reopening the comment period on its draft guidance for industry on declaring "evaporated cane juice" as an ingredient on food labels.  The agency originally published the guidance in October of 2009 and accepted comments through early December of that year. 

The draft guidance advises industry of FDA's view that sweeteners derived from cane syrup should not be listed on food labels as evaporated cane juice because the sweetener is not juice as juice is defined in Federal regulations (Title 21 of the Code of Federal Regulations, Section 120.1(a)). 

FDA is reopening the comment period for 60 days to obtain additional data and information to better understand the basic nature and characterizing properties of the ingredient, the methods of producing it, and the differences between this ingredient and other sweeteners.

Interested parties may submit comments by written letter or electronically starting March 5, 2014. Additional information, including directions for filing comments and the final due date for comments, is available in the Federal Register notice announcing reopening of the comment period.  

“Generational amnesia” about Raw Milk

Des Moines Register wrote about Mary McGonigle-Martin story, a mother who almost lost her son to an E. coli bacterial infection from raw milk. Mary McGonigle-Martin said, “The damage done by this bacteria is incomprehensible.”

McGonigle-Martin said she had believed natural-food enthusiasts’ claims that raw milk was healthier than unpasteurized milk. But the bacteria caused severe damage to her son’s kidneys and pushed him into heart failure. The boy, then 7, wound up on dialysis and needed surgeries. The ordeal, which began in 2006, led to more than $550,000 in medical bills.

“It is easy for people to be convinced that knowing your farmer and loving the cow will somehow magically prevent cow feces from getting into the milk,” she said. “We are all suffering from generational amnesia.”

Unpasteurized milk is 150 times more likely than pasteurized milk to cause foodborne illness. According to Dr. Ann Garvey, Iowa’s deputy state epidemiologist, people infected from consuming raw milk can pass the germs on to other people, who did not choose to eat or drink the untreated dairy products. For example, she said, an ill child from a family that drinks raw milk could spread bacteria to other kids in a child-care center.

Natural Almond Flavor and Allergen Labeling

[Emphasis added]

Here is a tricky question regarding the Food Allergen Labeling and Consumer Protection Act (FALCPA). "Tree nut" is not defined in the FALCPA, and the term is ambiguous because there are different uses for the term, "nut."  Most people know that peanuts, botanically, are not nuts but rather seeds. Similarly, almonds and pinyon seeds ("pine nuts") are not nuts botanically, but vernacularly they are referred to as nuts. 

On the other hand, annatto seeds are sometimes called nuts, but not routinely like pinyon seeds. FDA does not consider annatto to be a nut, so it is not treated as a major allergen under FALCPA.

Now let's get to the tricky part. Almonds are the seed of a tree closely related to peaches and apricots. For almonds, think of an ancient peach variety that was bred for the seed — the pit — rather than the fleshy fruit. So it is not surprising that peach pits and apricot pits have almond flavor. Consequently, most natural almond flavoring is derived from peach and apricot pits. (Yes the law permits it to be called "natural flavoring" because the flavor naturally occurs in the peach and apricot pits.) 

Under FALCPA if a product has almond-derived almond flavor, then almonds must be listed in the label's allergen statement. However, peach pits and apricot pits are not commonly thought of as tree nuts even though they are similar to almonds in many features and in being closely related. So for most people, the first reaction would be to exclude the peach pit and apricot pit from the allergen statement.

The dilemma arises because those who are allergic to almonds are known to sometimes have a cross-reaction to peach. It seems likely almond allergy could have a cross-reaction to peach pits and apricot pits. Yet, flavoring from peach and apricot pits could be hidden in a generic ingredient listing as "flavorings" or "natural flavorings". 

I asked FDA if it consider peach and apricot pits to be "tree nuts" for purposes of allergen labeling, but have received no response. FDA's interpretation is important because, if not considered tree nuts, then peach and apricot pits may not be listed in the "Contains" allergen statement. 

Nevertheless, the diligent manufacturer would want to inform consumers who might have an allergic reaction to peach or apricot pits. What would you suggest?

Save the Date: Summer Academy in Global Food Law and Policy

The Summer Academy in Global Food Law and Policy is a one-week summer program that brings together practitioners, policymakers, industry representatives, and leading academics working in the field of food law and policy. It offers intensive training on the most innovative developments in global food regulation and provides a unique opportunity for professional development and networking in an informal and interdisciplinary setting. By talking, studying, and interacting with food experts from all over the world, participants are able to gain new perspectives into both their own sectors and international regulatory issues. This is achieved by combining traditional classroom instruction with experiential learning opportunities offered by dedicated and distinguished international experts.

The 6th edition of the Academy will take place from Monday, 21 July, to Friday, 25 July, 2014, in Bilbao, Spain. The choice of this vibrant city will enable participants to benefit from the geographical location between the Atlantic sea and the Rioja region, as well as its distinctive architectural landscapes (with the Guggenheim Museum, Norman Foster's Underground, the towers by Arata Isozaki and César Pelli). For more information, please visit here.

The Summer Academy may be taken as a 3 credit, graduate-level course from Michigan State University.  Contact IFLR@msu.edu if you are interested in enrolling for graduate credit. If you wish only to attend as a seminar, enroll here.

FDA proposes "de-GRASing" artificial trans fat

The Food and Drug Administration today proposed measures that would virtually eliminate artificial trans fats. Based on new scientific evidence and the findings of expert scientific panels, the U.S. Food and Drug Administration (FDA) has tentatively determined that partially hydrogenated oils, which are the primary dietary source of industrially-produced trans fatty acids, or trans fat, are not generally recognized as safe (GRAS) for any use in food based on current scientific evidence establishing the health risks associated with the consumption of trans fat, and therefore that PHOs are food additives. Although FDA has not listed the most commonly used PHOs, they have been used in food for many years based on self-determinations by industry that such use is GRAS. If finalized, this would mean that food manufacturers would no longer be permitted to sell partially hydrogenated oils, either directly or as ingredients in another food product, without prior FDA approval for use as a food additive.

The Federal Food, Drug, and Cosmetic Act Turns 75

Seventy-five years ago on June 25, 1938, President Franklin Delano Roosevelt signed into law the Federal Food, Drug, and Cosmetic Act.