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
or


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 

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.

Tuesday, February 23, 2016

Pathogen testing and the safety of poultry parts


By Michaela Oldfield

The USDA FSIS recently finalized new poultry pathogen performance standards.

In brief, the finalized rule is establishing standards and testing procedures for assessing the level of salmonella and Campylobacter on chicken parts (read: chicken breasts, wings, thighs, etc.) and not-ready-to-eat comminuted chicken and poultry (read: ground chicken and ground turkey).  

While not a high-profile or contentious action (the proposed rule only received 15 comments), FSIS projects it will prevent 50,000 illnesses annually. As part of a broader collaboration between USDA, FDA, and CDC to address foodborne illness in the US food supply, this is but one step in reducing the 48 million people who will likely get sick this year.

One might ask: How does assessing the level of salmonella and Campylobacter in poultry products reduce illnesses? And why does this seemingly uncontroversial rule matter?

Understanding the implications of FSIS’s action requires understanding how the pathogen standards fit into the FSIS’s Hazard Analysis and Critical Control Point (HACCP) regulatory system.

There are two important points for students of food law to understand.

First, salmonella and Campylobacter are not considered “adulterants” in meat and poultry.
If you’re more familiar with FDA law, this may come as a surprise.

As with FDA regulated foods, the definition of adulterated provides:

The term "adulterated" shall apply to any … meat …(1) if it bears or contains any poisonous or deleterious substance which may render it injurious to health; but in case the substance is not an added substance, such article shall not be considered adulterated under this clause if the quantity of such substance in or on such article does not ordinarily render it injurious to health. 21 U.S.C. § 601(m)(1)

However, in American Health Association v. Butz, 511 F.2d 331 (U.S. App. DC, 1974), the court of appeals for the D.C. Circuit concluded that the term “adulterated” does not include “substances such as salmonellae which may be inherent in the meat.” Id. at 334. In the court’s opinions, “American housewives and cooks normally are not ignorant or stupid and their methods of preparing and cooking of food do not ordinarily result in salmonellosis.” In other words, consumers  know that they should thoroughly cook meat. So since bacteria are not added substances, and they do not ordinarily render the product injurious (because presumably consumers will cook it properly), it is not an adulterant.

Now for the second, more important point. Since these bacteria are not adulterants, FSIS can only bring enforcement actions if food is being packed under conditions where it is likely to become adulterated. FSIS can not pull inspectors from the facility or stop production merely because they detect the presence of pathogens that are not considered adulterants. Supreme Beef Processors, Inc. v. USDA, 275 F.3d 432 (5th Cir. 2001).

If exceeding the performance standards doesn’t give the agency authority to stop production, it may seem like the agency is hamstrung - Supreme Beef Processors was considered a major blow to FSIS’s enforcement authorities.

Which brings us to asking and answering, “How is it that simply testing for salmonella and bacteria is expected to reduce illness?”

In their initial rulemaking on HACCP, the FSIS established pathogen standards because “HACCP-based process control must be combined with objective means of verifying that meat and poultry establishments are achieving acceptable levels of food safety performance.” Pathogen Reduction; Hazard Analysis and Critical Control Point (HACCP) Systems, 61 FR 38806, 38835 (July 25, 1996).

So the testing standards are not about detecting salmonella because it can make people sick, but are about detecting when a company’s HACCP system is not adequately effective.

If FSIS detects levels above what they are stating for their tolerances, they can warn the company that there is a problem. If FSIS wants to take an enforcement action beyond issuing a warning, the agency will need to do an investigation that would allow them to establish the company is packing or processing products under unsanitary conditions. So systematically exceeding the tolerance levels will trigger the FSIS to give closer scrutiny to the plant’s HACCP plans and implementation.

This may seem ineffective. Indeed, consumer advocacy organizations often call for Congress to grant the USDA the authority that was rejected in Supreme Beef.

However, in practice, even though the agency doesn’t really have this authority, they can (and do) still threaten to withdraw companies’ grant of inspection if they don't do anything about the contamination. The reality has generally been that it is easier to comply with FSIS’s requests than to attempt to challenge in court the agency’s action. Even though they could litigate it, very few companies go to court to challenge FSIS’s enforcement actions. Dennis R. Johnson and Jolyda O. Swaim, The Food Safety and Inspection Service's Lack of Statutory Authority to Suspend Inspection for Failure to Comply With HACCP Regulations, 1 J. Food L. & Pol’y 337 (2005).

[1] FYI - this is a case involving the MPIA, whereas chicken and turkey fall under the PPIA. For purposes of this discussion, I am using case applying each statute interchangeably because the applicable language is substantially the same.

Tuesday, February 16, 2016

A follow-up on preemption and the chaotic fragmentation of U.S. food regulation


By Michaela Oldfield

I have another case to share as a follow-up to my earlier post on preemption. It drives home a point that is important to keep in mind: food regulation is fragmented. If it wasn’t clear in the last post, the laws governing food safety and food labeling in general are distinct from the laws governing food safety and food labeling in meat and poultry.

In Del Real LLC. v. Kamela Harris, No. 13-16893, slip op. (9th Cir. Feb 12, 2016 ) the U.S. Court of Appeals for the 9th Circuit upheld a district court ruling that California state officials cannot enforce “slack fill” label and packaging requirements under state law because they are preempted by the federal Meat Inspection Act (FMIA) and the federal Poultry Products Inspection Act (PPIA).

Remember how the FMIA and PPIA have language prohibiting any regulation of “marking, labeling, packaging or ingredient requirements … in addition to, or different than” those mandated by federal law? 21 U.S.C. § 678,  21 U.S.C. § 467e.

If the suit had been about another type of food, the preemption outcome might have been different.

People talk about our food regulatory system being fragmented and dysfunctional – preemption is one example of how arcane policy choices made decades ago create a complicated regulatory landscape we see today. These few posts don’t  even begin to cover the other federal agencies with jurisdictional oversight, such as EPA, NOAA, and TTB (among many others), and how they relate to one another and state regulation. Imagine if you wanted to market gluten free, organic beer in several states in the North East. Could you even guess where to start? (Hint, call a lawyer and pay them to figure it out!)

So this raises the question, should the  jurisdictional chaos between feds and states and different agencies be resolved, and if so, how? It's a difficult issue that’s regularly debated. My point that I want to make is that in considering the options, an important step is for food law students and advocates to examine how the current system operates. An expedient policy change today could have long term, unintended ripple effects on other policies if their relationships are not fully understood!

Monday, February 01, 2016

Clarification: The Vermont-GMA GE labeling skirmishes are not over

As a follow-up post to my discussion of state law and federal preemption, I need to provide some clarification on the status of the Vermont case.

In that post, I discussed a decision in Grocery Mfr. Ass'n v. Sorrell, No. 5:14-cv-117 (D. Vt. Apr. 27, 2015), where the district court dismissed several of the plaintiff’s preemption claims.

This was done because Vermont filed a motion to dismiss pursuant to rule 12(b) of the federal rules of civil procedure. There’s a number of reasons a case can be dismissed, such as if the parties settle and want the case dismissed. In this instance, Vermont was requesting that GMA’s claim be dismissed for failure to state a claim. Fed. R. Civ. P. 12(b)(6). Grossly over simplified, this is basically asking the court to get rid of the case because the law does not actually prohibit or govern the conduct the plaintiff is filing suit over.

The previous post focused on the concept of preemption - one of several reasons a state law could be invalid.

Importantly, GMA made a number of other claims about violations of free speech protections, due process, and the dormant commerce clause. The court DENIED many of Vermont’s motion to dismiss these claims. These claims will be litigated at trial and could ultimately restrict Vermont’s ability to regulate the labeling of GE foods.

Further, The plaintiffs are appealing the decision. This means the U.S. Court of Appeals for the Second Circuit will review the district court’s decision. They may conclude that the claims are potentially preempted and require the district court to reinstate the claims and allow the litigation to move forward.

So lest anyone take away from my last post that the GMO labelling issues are resolved, they are not!

Friday, January 22, 2016

Eat your rainbow, but watch out for the bugs!

How can we balance competing public health concerns for needing to make fruits and vegetables an accessible, affordable part of Americans’ lives, while protecting ourselves from some nasty little microbes?

By Michaela Oldfield

The dietary guidelines for Americans were recently released, with a message that we should eat more fruits and vegetables and less sugar. Meanwhile, John Oliver’s bit on food waste and #foodwaste have drawn my attention to a related quandary: millions of tons of healthy food go to waste in the U.S., while we struggle with the burdens of diet-related diseases.
While a lot of the media I see focuses on the cosmetic and superficial reasons food is thrown away, I find myself thinking about the legal issues. One of the first food law research topics I worked on concerned the Bill Emerson Good Samaritan Food Donation Act, which, as explained here, provides liability protections to companies that donate food to non-profits in good faith.
In this blog post I will describe how risks of microbial contamination intersect with food waste in the fresh produce sector.
The thing about fresh produce is that it’s fresh. It doesn’t go through a kill step to eliminate contamination. If contaminated produce is sold, it can lead to serious, potentially fatal illnesses. If it's not sold, it may end up as millions of pounds of healthful food rotting in waste facilities when there’s no secondary processing market that the crop can be diverted to.
Worse yet, when safe produce is linked to a foodborne illness outbreak, perfectly good produce may also be sent to landfills. But if an outbreak is occurring, there are important reasons to stop sales of all foods associated with the outbreak until the source can be accurately identified. So how should this be dealt with?
A case that was decided this past October, Dimare Fresh v. United States, No. 15-5006 (Fed. Cir. Oct. 28, 2015),  provides a great jumping-off point to examine the legal aspect of this public health challenge.
This case arose because in the summer of 2008, in the midst of an investigation into an outbreak of salmonella poisoning, the FDA issued a warning about a possible connection between the outbreak and tomatoes from Florida. The agency then issued a series of statements clarifying the suspected connection and ultimately removing the warning. The source of the outbreak was eventually traced to peppers, but the market demand for fresh tomatoes from Florida plummeted. There was no processing market available and the growers lost almost all of their remaining crop. The growers then brought a takings claim against the FDA, arguing that the agency’s action destroyed all economic value of their crop.
The case dealt with the question, “Should the FDA have to compensate growers for losses due to FDA’s erroneous warning?” The Court of Appeals for the Federal Circuit said no. But why not? And so what?
The claim is a regulatory takings claim under the Takings Clause of the Fifth Amendment, which prohibits the government from ‘taking’ private property for public use without just compensation. There are several categories of takings. The classic taking is when the government directly appropriates property for its use. The FDA did not seize the tomatoes at issue, so there was no issue of this being a classic taking.
Courts also recognize regulatory takings, where a government restriction on the use of property goes ‘too far’. Regulatory takings can be categorical, where the government compels an owner to suffer physical invasion of their property or prohibits all economically beneficial use. Or a regulatory taking can be reviewed ad hoc, where the court considers the economic impact of the regulation, a plaintiff’s investment backed expectations, and the character of the government action. Dimare Fresh, No. 15-5006  at 9-10 (citations omitted).
The tomato growers argued that issuance of the press releases constituted an exercise of FDA’s regulatory authority and constituted a regulatory taking. Though not a formal order, the warnings had the practical effect of stopping all sales, purchases and deliveries, and were authorized by a regulation.
Although the FDA acted according to its legal authority, that was not sufficient in the court’s eyes to produce a regulatory taking. The issue is whether there was an actual taking of the tomato growers’ property.
Unfortunately for the tomato growers, they were trying to create a takings claim out of a market response to a government action. Without “coercion, legal threat, regulatory restriction, or any binding obligation” the court refused to find a regulatory taking.  Dimare Fresh, No. 15-5006 at 16. In my interpretation of this, the court delineated a critical difference between a regulatory action that directly restricts or controls actors’ rights to their property and a regulatory action that merely provides information to other actors.
What’s particularly interesting to me about this case is the implications it potentially has for how public health officials and businesses interact to respond to foodborne illness outbreaks.
At the time of the outbreak, the Florida tomato industry had industry-wide requirements for food safety practices and a traceback system for finding the source of an outbreak. As I understand it, these were industry leading practices. What more could the growers have done to protect themselves? Why should they bear the cost of someone else’s error?
One way to protect themselves is to ensure that everyone is following certain minimum food safety practices. This would help protect the tomato growers from being connected to outbreaks associated with a completely different commodity, as happened here, by  increasing preventive measures to reduce the outbreaks overall. This was in part the motivation behind the produce standards required in the Food Safety Modernization Act.
But prevention doesn’t address how to allocate costs when an outbreak occurs. If people are getting sick, there is general agreement that there is a public health imperative to act. But when action is taken, who should bear the cost? The public at large, or the companies that produce the product? By imposing regulatory takings burdens on the FDA, the cost of their bad call could have been spread across the public through tax dollars. But it also could have had a chilling effect on the FDA’s willingness to issue alerts. That cost would come out of their operating budget, which is already inadequate for their responsibilities.
Finally, there’s the question of what to do with those tomatoes? The tomatoes growers alleged they had no ‘practical alternative to preserve their tomatoes’ when the market dropped. In the John Oliver bit on food waste a few months back, there was footage showing piles of fresh produce in the Salinas Valley being sent to landfills. My first reaction when I saw those piles was to assume they had some sort of microbial contamination. Rather than risk making their customers sick with potentially life- threatening illness, the companies chose to destroy entire fields.
It’s sad to see product that people put so much work (and water!) into producing is being wasted, while there is a major nutrition and obesity problem in our country linked to lack of access to these essential foods.
I know some of these crops are rejected for failure to meet cosmetic standards. The ugly food movement is about overcoming those issues. And for some crops there are systems in place to divert below standard produce to processing.
But why don’t we have the systems in place to divert more products into a processing facility where they would go through a kill step that makes them safe to eat? What could law and policy do to overcome the economic barriers and facilitate those secondary supply chains?
I do not know enough about fresh and processed produce supply chains to be able to answer these musings, but I would love to see some creative minds develop alternative processing supply chains for fresh produce that’s dinged for microbial contamination.
It looks like a potential win-win for the produce industry and public health advocates.

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