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. 

The Colbert Report
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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.

Database of Dietary Supplement Labels

A database of labels of dietary supplements being sold in the United States is a joint project of the National Institutes of Health (NIH) with the National Library of Medicine The database information comes from the dietary supplement labels and may or may not be meet current requirements.

The database can be browsed or searched by key word, ingredients, product name, or claim language. NIH plans to eventually include most of the more than 55,000 dietary supplement products sold in the U.S., but the database currently contains about one third of the labels.

Last Chance to Register - Summer Academy in Global Food Law and Policy

The Summer Academy in Global Food Law and Policy is an established 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 5th edition of the Academy will take place from Monday, 22 July, to Friday, 26 July, 2013 in Granada, Spain. The choice of this vibrant city will enable participants to benefit from the distinctive beauty of the town’s Unesco World Heritage environment and its privileged geographical location adjacent to the Sierra Nevada. For more information, please visit here.

The Summer Academy may be taken as a 2 or 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.

Record-High Antibiotic Use for Animal Feed

In 2012 FDA proposed voluntary guidelines designed reduce antibiotics use in animal feed. There is scientific consensus that antibiotic use for growth promotion is inappropriate and should be ended. The Pew Charitable Trusts compared the numbers on antibiotic use on livestock farms to data on human use of antibiotics to treat illness. Their infographic appears below. 

Patent Rights, Exhaustion Doctrine, and Monsanto

On February 19, 2013, the Supreme Court heard oral arguments in Bowman v. Monsanto Co., involving an Indiana farmer who replicated Monsanto’s patented seeds them without paying the company a fee. Farmers who buy this patented seed must generally sign a contract promising not to save seeds from the resulting crop, which means the farmers must buy new seeds every year. Vernon Bowman had signed such contracts for his main crop but used what he thought was loophole: Rather than replant his own seed, he bought seed from a grain elevator filled with a mix of other farmers’ seeds.

The Roundup Ready soybean is the most popular variety in the U.S., so it was reasonably certain Bowman would receive mostly patented soybeans from the elevator. Mr. Bowman planted these seeds, then sprayed them with Roundup, so only the Roundup Ready soybean plants survived, and he saved those seeds for further plantings.

Mr. Bowman argued that the doctrine of patent exhaustion allowed him to do what he liked with products he had obtained legally. Under this doctrine, when an owner of intellectual property sells a copy of the property, the buyer is free to do what it wishes with the product. However, Justice Sonia Sotomayor noted, “The exhaustion doctrine permits you to use the good that you buy. It never permits you to make another item from that item you bought.”

The farmer’s lawyer said that companies could rely on contracts rather than patent law to protect their inventions. Justice Elena Kagan said, “It seems to me that that answer is purely insufficient in this kind of a case, because all that has to happen is that one seed escapes the web of these contracts, and that seed, because it can self-replicate in the way that it can, essentially makes all the contracts worthless.”

Justice Stephen G. Breyer said that there are lots of things someone could do with the seeds he had bought from the grain elevator. “You can feed it to animals, you can feed it to your family, make tofu turkeys … But I’ll give you two that you can’t do. One, you can’t pick up those seeds that you’ve just bought and throw them in a child’s face. You can’t do that because there’s a law that says you can’t do it. Now, there’s another law that says you cannot make copies of a patented invention.”

This intentional replication of the patented seeds infringes the patent, the same as someone makes thousands of copies of a CD he purchased. As Justice Breyer implied, this case really has nothing to do with the exhaustion doctrine and really is groping for a new doctrine or a new right for farmers to reproduce patented seed. This would make seed patents largely worthless.

As Chief Justice Roberts asked, “Why in the world would anybody spend any money to try to improve the seed if as soon as they sold the first one anybody could grow more and have as many of those seeds as they want?”