Monday, July 25, 2016

The GMO labeling bill – what does it really mean?

By Michaela Oldfield

As we were wrapping the final day of the MSU Food Law Current Issues seminar, Congress finally passed a GMO labeling bill,[1] S. 764, 114th Cong. (2016).  I would be remiss if I didn’t delve into it a little bit.

The bill and labeling issues in general were a hot topic at the seminar. Rather than delve into the political controversies, I am going to draw on the seminar discussion to explore the legal issues that I see in specific provisions in the bill.

For alternative interpretations of the bill, you can read Civil Eats’ story on what it means for consumers (and especially those of the “no-GMOs” variety) and Politico’s coverage of the USDA-FDA battle over interpretation of the bill and analysis of the winners and losers.

Of course, the big news and the reason the bill has just been enacted is that it preempts state labeling requirements. It states:

‘‘FEDERAL PREEMPTION - No State or a political subdivision of a State may directly or indirectly establish under any authority or continue in effect as to any food or seed in interstate commerce any requirement relating to the labeling of whether a food (including food served in a restaurant or similar establishment) or seed is genetically engineered (which shall include such other similar terms as determined by the Secretary of Agriculture) or was developed or produced using genetic engineering, including any requirement for claims that a food or seed is or contains an ingredient that was developed or produced using genetic engineering.” S. 764, 114th Cong. § 295(b) (2016).
You may remember from my discussion of the GMA’s suit over Vermont’s GMO labeling bill litigation that there are three basic types of preemption: express, field and conflict. This is an express preemption.

Before anyone gets overly excited though, the bill has an exception to this preemption. S. 764, 114th Cong. § 296 (2016) states ‘‘Nothing in this subtitle, subtitle E, or any regulation, rule, or requirement promulgated in accordance with this subtitle or subtitle E shall be construed to preempt any remedy created by a State or Federal statutory or common law right.” So the law doesn’t preempt causes of actions a citizen might bring under state consumer protection laws.  That means claims alleging consumer misrepresentation for things like “100% natural” and “all natural” and other terms where consumers object to the use of GMOs in a product are not preempted.

 The bill, of course, defines what bioengineering is with respect to food. It is food.

“(A) that contains genetic material that has been modified through in vitro recombinant deoxyribonucleic acid (DNA) techniques; and

(B) for which the modification could not otherwise be obtained through conventional breeding or found in nature.” S. 764, 114th Cong. § 291 (2016).

This has two regulatory issues. First, this requires trying to prove a negative – that something could not otherwise be obtained through breeding or found in nature. This is a difficult, if not nearly impossible, task. USDA can try to set a standard for establishing the negative, but I would bet this will end up in litigation.

The definition also means there are a lot of foods that will likely not be required to have a GE label because they do not contain any GE DNA, even though a GE was used in the production of the product. For instance, cheeses often contain rennin that is produced by GE fungi, citric acid is produced from a GE mold, and any number of products from GE crops may be so highly refined that there is no genetic material left (more on this last point later).

Another use of GE crops in the food system is as feed for animals. The law explicitly addresses this by prohibiting animal-derived foods from being a GE food just because an animal consumed GE feed. S. 764, 114th Cong. §. 293(b)(2)(A) (2016).

Interestingly, authority for establishing the mandatory labeling requirement is assigned to the USDA. S. 764, 114th Cong. § 291(3) (2016) states that "Secretary" means the secretary of agriculture, and S. 764, 114th Cong. § 293(1) (2016) states that the Secretary shall ‘‘establish a national mandatory bioengineered food disclosure standard with respect to any bioengineered food and any food that may be bioengineered.”

However, under Sec 292, the law will only apply to foods that are regulated under the Food, Drug and Cosmetic Act (which, you should recall, are regulated by the FDA under 21 U.S.C. § 321(d)). If it’s a product subject to the Federal Meat Inspection Act (21 U.S.C. 601 et seq.), the Poultry Products Inspection Act (21 U.S.C. 451 et seq.), or the Egg Products Inspection Act (21 U.S.C. 1031 et seq.), the GE labeling bill will apply if “the most predominant ingredient of the food would independently be subject to the labeling requirements” of the FDCA. S. 764, 114th Cong. § 292(c)(2) (2016). If the product is broth, stock, water, or a similar solution, then the GE labeling will only apply if the second most prominent ingredient would be required to be labeled under the FDCA. S. 764, 114th Cong. § 292(c)(2) (2016).

So read here: this only applies to FDCA regulated foods, or meat, poultry, and egg products if the first ingredient on its own would be subject to FDCA labeling requirements or liquids if the second ingredient on its own would be subject to FDCA labeling requirements. Yet now USDA is going to be responsible for developing and enforcing labeling regulations. If you’ve taken U.S. food law, you will realize this adds regulatory confusion to an already chaotically organized food regulatory regime in the U.S.

For highly refined products, there’s an additional issue that the law allocates to USDA for resolving. ‘‘A regulation promulgated by the Secretary in carrying out this subtitle shall …‘(B) determine the amounts of a bioengineered substance that may be present in food, as appropriate, in order for the food to be a bioengineered food.” S. 764, 114th Cong. § 293(b)(2) (2016). So basically, USDA will have to answer the question “What is the threshold level that will trigger the requirement that the food must be labeled?”

This threshold issue also applies for labeling of grains that have been inadvertently commingled with a GE grain. So, for instance, corn, soy, wheat, and oats are often grown in rotations and handled through the same supply chain. This is so common that USDA commodity grading standards have established allowable thresholds for the presence of other grains in the commodities, 7 C.F.R. §§ 810.101 et seq

Issues with comingling and cross contact have been coming up more with allergens and gluten-free labels. For instance, oats are a non-gluten containing grain that should be able to be labeled gluten-free under FDA’s labeling rules. However, they sometimes contain gluten due to cross-contact in the supply chain. FDA addressed this by establishing a threshold for gluten-free labeling claims that allowed up to 20 ppm gluten in products and ingredients under certain conditions. 21 C.F.R. § 101.91.

How much cross-contact will a company have to prevent if it's not going to label its product as having a GE ingredient? The USDA’s answer to the threshold question will help companies navigate this.

Just because a food isn’t required to have an affirmative GE declaration does not mean that it can be labeled as non-GE. For GE ingredients, the bill states “food may not be considered to be  ‘not bioengineered’, ‘non-GMO’, or any other similar claim  describing the absence of bioengineering in the food solely because the food is not required to bear a disclosure that  the food is bioengineered under this subtitle.” S. 764, 114th Cong. § 294(c) (2016). Going back to an earlier point about preemption, even if a company complies with this prohibition, it doesn’t mean consumers may not bring some other misleading labeling claim under state law. If a food contains GE ingredients below the mandatory labeling threshold, but uses a marketing term that a consumer interprets to mean it is GE-free, this would potentially expose the company to litigation liabilities.

The bill does have a little savings clause for organic foods. Being certified as Organic under the Organic Foods Production Act of 1990 (7 U.S.C. 6501 et seq.), will be considered sufficient to make a claim such as “non-GMO” or “GMO-free” claim. S. 764, 114th Cong. § 2 (2016).
If you’ve followed the news coverage, you should also know that the bill is set up to allow manufacturers to label their product with text or a digital link (i.e. QR code), with some additional potential labeling options for particularly small packages and small companies. S. 764, 114th Cong. § 293(d) (2016).

In terms of enforcement, that too will fall to the USDA. The bill actually amends the Agricultural Marketing Act of 1946 (AMA) (7 U.S.C. 1621 et seq.). S. 764, 114th Cong. § 1 (2016). If you’re not familiar with this law, you should go explore it a little. The law is about giving the USDA powers to develop and manage agricultural markets. Here’s an excerpt from the congressional declaration of purpose, 7 U.S.C. § 1621:

... it is the intent of Congress to provide for (1) continuous research to improve the marketing, handling, storage, processing, transportation, and distribution of agricultural products; (2) cooperation among Federal and State agencies, producers, industry organizations, and others in the development and effectuation of research and marketing programs to improve the distribution processes; (3) an integrated administration of all laws enacted by Congress to aid the distribution of agricultural products through research, market aids and services, and regulatory activities, to the end that marketing methods and facilities may be improved, that distribution costs may be reduced and the price spread between the producer and consumer may be narrowed, that dietary and nutritional standards may be improved, that new and wider markets for American agricultural products may be developed, both in the United States and in other countries, with a view to making it possible for the full production of American farms to be disposed of usefully, economically, profitably, and in an orderly manner.
The GE bill makes failing to make a required disclosure a prohibited act and requires companies to maintain and make available to the USDA any records that the USDA decides to require. S. 764, 114th Cong. §§ 293(g)(1)-(3) (2016). USDA’s enforcement authority of the labeling is limited to inspection of the records and publicizing a summary of the records audit (after a notice and hearing with the person who was the subject of the record). S. 764, 114th Cong. § 293(g)(3) (2016). The bill explicitly prohibits the USDA from requiring a recall of a mislabeled product by stating “The Secretary shall have no authority to recall any food subject to this subtitle on the basis of whether the food bears a disclosure that the food is bioengineered.” S. 764, 114th Cong. § 293(g)(4) (2016).

Normally this would seem like weak enforcement authority that undermines the potential effectiveness of a bill. However, the non-preemption of state causes of action for consumer deception means citizen suits through civil litigation will augment the USDA’s enforcement authority. In the same way that bloggers are testing gluten-free products and publicizing if they contain gluten (even when within the 20 ppm allowed by the FDA), citizens can test, publicize, and litigate any product that fails to accurately disclose the presence of GE ingredients in the food.

So that’s the fun new permutations of labeling law that we’ll have in the U.S.

Here’s some key takeaways for our food law student readers:

So remember, understanding this law (like all laws) will require analysis of the codified statute, the regulations, and any case law, as well as synthesizing interpretations of overlapping and related statutes, regulations, and case law.

[1] For any of you working on your legal research skills, here’s a fun issue you should note. The bioengineered labeling bill is titled “A bill to reauthorize and amend the National Sea Grant College Program Act, and for other purposes”. Say what? Congress has a little switcheroo maneuver that they pull sometimes, where they completely substitute the text of one bill for another. This can make it difficult to find the original text of a bill if you’re only searching by what you think the name is. Sometimes you’re better off searching by the bill’s number or sponsors’ names. 

Thursday, July 14, 2016

MSU Food Law Trivia Champions

Some of the participants at the MSU Food Law Current Issues Seminar happened upon a trivia contest at dinner. By chance, the first category was “food.” Needless to say, they slammed the competition! They won the shirt displayed in the photo.

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.

Wednesday, April 13, 2016

>> 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

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: 

Tuesday, April 05, 2016

Ever heard of a letter of no objection?

By Michaela Oldfield / Global Food Law Fellow

Me neither, until I went to a lecture at the Food Science and Human Nutrition Department on the safety of recycled plastics in food contact materials. Anyone familiar with the ol’ BPA in canned foods issue should know that what is in the materials that food is packaged in is as important as what is actually in the food.

I’ll get to the letter of no objection, but first want to explain how food packaging material is generally regulated. Because recycled plastics are a deviation from the usual pre-market approval that most food packaging goes through.

Under the Food, Drug, and Cosmetic Act (FDCA), 21 USC 301 et seq., the FDA regulates materials in food packaging as food additives if they have the potential to become a component of or otherwise affect the characteristic of a food. 21 USC 321(s), 21 C.F.R. § 170.3(e)(1). Such product are known as Indirect Food Additives.

The FDCA treats food contact substances that are food additives as unsafe unless there is regulation prescribing the conditions when the additive may be safely used, 21 USC 348(a)(3)(A), or a company has submitted a notification to the FDA and the notification is effective, 21 USC 348(a)(3)(B).

The regulations allowing food contact substances are pretty straightforward. The FDA has promulgated a list of materials that can be indirect additives. 21 CFR parts 176-178. A material may also be exempt from regulation because it falls under a regulatory threshold. 21 CFR 170.39. There is a list of materials and their intended uses that have met this exemption.  

The notification process, on the other hand, is not so straightforward. A notification is submitted according to procedures laid out in 21 USC 348(h). A manufacturer may submit a notification to the FDA at least 120 days prior to introducing a food contact substance. (Note the “may”. This process is technically voluntary. However, if food contact material is an additive, and it is not generally recognized as safe, then the product will be deemed adulterated absent an FDA accepted notification. So the notification process becomes de facto mandatory for many new food packaging materials).  

The notification must provide the identity and intended use of the substance and the manufacturer or supplier’s determination that the substance is safe and doesn’t cause cancer, and the information that forms the basis for the safety determination. 21 USC 348(h)(1).

The notification becomes effective 120 days after submission to the FDA unless the agency makes a determination otherwise. 21 USC 348(h)(2). The agency may either object to the notification, 348(h)(2)(A), or require the manufacturer or supplier to submit a petition for regulation of the food contact substance 348(h)(3). This is the Food Contact Substance Notification program. The FDA maintains a list of additives that have been approved through this procedure.

To recap: a food contact substance is deemed unsafe unless it is allowed by regulation or there is a notification in effect. A company may submit the notification, and unless the FDA takes action, the notification becomes effective 120 days after submission to the FDA. If the FDA does not object, they will issue a letter notifying the submitter of the food contact substance and the date the notice became effective.

So here’s what that all has to do with a letter of no objection.

Like any other food contact substance, recycled plastics used in food packaging become food additives if they have the potential to become a component of the food or affect its structure. Thus, recycled plastics must meet all applicable regulations on indirect food additives.

On paper, this is easy peasy. Source plastics that were previously food contact substances, reprocess them into new packaging, and you’ve got a food contact substance that meets the applicable regulations.

The reality is recycling is a messy, funky process that involves a lot of products being mingled, mashed up, solvenized, blended and I don’t know what else. And this is done all over the world, subject to whatever regulatory authority operates in the country where the recycling occurs.

A supplier may promise that a recycled plastic meets the FDA standards, but food manufacturers sourcing post-consumer plastic for a product may want to be a little more confident that their packaging material will meet the FDA’s standards and consumers’ expectations.  Companies can use one of three approaches to do this.

    1. They can send the packaging to a lab to be tested for contaminants. The speaker noted he has found that by the time the results get back to a company the packaging has often already been put on food and sent out into the marketplace. When this happens, the food manufacturer often requests a credit from the plastic supplier for providing a plastic that did not meet the standards the supplier promised. Unless a consumer advocacy group or the FDA randomly tests the packaging material, it likely ends there.
    2. The company can integrate continuous material testing into the manufacturing process so that a company can know what is in their packaging materials before they even put food anywhere near it. This technology is not fully operational yet, but food manufacturers are investing in its development. Someday that packaging material might even have a QR code that can give consumers the exact data from the in-time monitoring about what materials are in their food’s package.
    3. The food manufacturer can source recycled plastic from a company that has obtained a  “letter of no objection” from the FDA verifying that the waste stream and recycling process should result in a plastic that meets FDA’s standards.  

Do any of these look problematic? The first one might be worrisome to consumers, but Dr. Vorst has found the third is actually far more problematic. Even though on paper it all looks good, there’s never any verification that a company is actually using the recycled materials they said they would or putting them through the process they claimed to have.

This kind of on-paper compliance and in-reality disconnect might sound familiar to anyone that has followed the drama of food safety certifications and the enactment of the Food Safety Modernization Act over the last 10 years.

So what’s going on, what is a letter of no objection and why does the FDA issue them?

Like food manufacturers, the FDA has concerns about the suitability of recycled plastic for food contact materials. “FDA considers each proposed use of recycled plastic on a case-by-case basis and issues informal advice as to whether the recycling process is expected to produce plastic suitable for food-contact applications.” The agency provides guidance on how to determine the suitability of recycled plastics and what information should be submitted to the agency to receive this informal advice.

So the letter is documentation that the FDA has reviewed the company’s proposed waste stream and recycling process, and according to their assessment the resultant plastic will meet the FDA’s standards for food contact materials.

Why provide guidance and letters of no objection, rather than require testing and approval? In short, the FDA doesn’t have authority to mandate that companies do pre-testing on their food contact materials. FDA’s authority is to require premarket approval of food contact substances, which applies to virgin materials. As long as a company is sourcing from an appropriate waste stream, the materials will have already received premarket approval.

The FDA can test recycled plastics after they’re on the market to ensure that the manufacturer used an appropriate waste stream. But the FDA has limited resources at best to engage in this kind of oversight and enforcement. Providing guidance and informal advice was the next best thing the FDA could do to try to regulate recycled plastics in food packaging materials.

As it stands, it falls to companies to figure out which plastics meet the FDA’s standards and which don’t. If they ignore the issue, a random consumer advocacy organization doing testing could expose them - and their entire product industry, such as bottled water - to scrutiny and bad PR.

With advances in technology and faster lab diagnostics, companies will be able to bypass this system and rapidly test raw materials as they come in to evaluate whether they’re usable. By the same token, it will become easier for consumer groups and the FDA to do the same with finished products, putting more pressure on companies to avoid unscrupulous suppliers.  

So now that I’ve added to the litany of issues spurring consumer fears about plastic, I’ll add one last gem. While food packaging materials are at least loosely regulated, the solvents and binders in paper products are largely unregulated. Unless a company uses stringent material sourcing, the problems from general paper production can seep into food packaging materials.

The speaker had an example of the paper wrapping on chocolate creating an off flavor that was bad enough to prompt a consumer complaint and spur the company to investigate!  Lesson: I should stop microwaving my popcorn in a brown paper lunch bag, even though it is easier than stove top and cheaper than store-bought microwaved popcorn.

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