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!

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