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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