Friday, December 18, 2015

FDA’s AquaAdvantage approval - Understand the law, evaluate the politics of policy change (Michaela Oldfield)

FDA’s AquaAdvantage approval

Understand the law, evaluate the politics of policy change
By Michaela Oldfield

Several weeks ago, the FDA released its approval of AquaAdvantage salmon. Food and ag lawyers at other blogs quickly jumped in with analyses and further information on the action.

For our students, I want to highlight several components of the approval that I think they should understand and examine. The goal with this post is to highlight the sources of law governing FDA’s action and provide a brief explanation of the legal rationale that produced the outcome.

First, the Approval is for AquaAdvantage as a new animal drug - this makes it a different procedure than what commercially available GE Crops have gone through. Here’s a little chart summarizing the differences:

GE Crops
GE Salmon
Considered “substantially equivalent” to non-GE crops; manufacturers may voluntarily request FDA review of GRAS determination
new drug approval
Review as a pesticide if the plant is engineered to endogenously produce a pesticide
APHIS review of plant pest risk
generally N/A, unless potential to impact endangered species
Section 7 ESA consultation with FDA because of potential impact on endangered Atlantic salmon

The GE salmon is being approved through the NADA process because the gene expression therapy qualifies as a drug under 201(g)(1)(C) of FDCA, which defines a drug as “articles (other than food) intended to affect the structure or any function of the body of man or other animals”.

In class, a teacher might ask if can you construct a legal argument that the salmon should be approved as a food or an additive, rather than a drug? In the world of food and drug law, this is an important argument to be able to make because the distinctions between a food, a drug, and an additive are high-stakes issues due to the differences in the regulatory regime for each item.

To make your argument, you need to start with the definitions in the law, which are codified at 21 U.S.C. 321:
  • (f) The term “food” means (1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article.
  • (g)(1) The term “drug” means ...(C) articles (other than food) intended to affect the structure or any function of the body of man or other animals

With those definitions alone you can’t distinguish between a food and a drug. So you then need to go to case law to see how the courts interpret and apply that distinction.

A seminal case distinguishing a food from a drug is Nutrilab, Inc. v. Schweiker, 713 F.2d 335 (1983), in which starch blockers derived from beans were determined to be a drug because they “were not consumed primarily for taste, aroma, or nutritive value.” (This is only one case being given as an example - if you want to convince a judge, you would need a lot more than this!). So the rDNA technology affects the structure and function of the fish, and it's not being consumed for taste, aroma, or nutritive value and so it's arguably not a food.

But is there an argument the new gene it creates in the salmon is a food additive? In 21 USC 321(s) the term “food additive” means any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food.
Food and Water Watch tried to argue the salmon should be reviewed as a food additive and denied approval as not “generally recognized as safe” (GRAS) because the “process significantly alters the salmon’s composition... in a way that is reasonably expected to alter its nutritive value or concentration of constituents, and the new substance raises safety concerns.” Citizen Petition To Deem AquaBounty Technologies’ Genetically Engineered AquAdvantage Salmon An Unsafe Food Additive, p 2.

By the FDA’s regulation, if a food that is commonly consumed for its nutritive value “has had significant alteration of composition by breeding or selection...where the change may be reasonably expected to alter the nutritive value or the concentration of constituents” it must be “reviewed as and affirmed as GRAS or determined to be a food additive . . . .”21 C.F.R. § 170.30(f)(2) (2014).

FDA rejected FWW’s argument on the grounds that the salmon can not be approved as a drug and a food additive, and must necessarily undergo the drug approval process. Further, as part of the safety evaluation for the approval of a new animal drug, the FDA must evaluate the potential risks of “any substance formed in or on food because of the use of [the] drug” 21 U.S.C. 360b(d)(2)(a). FDA evaluated the salmon and the Gene Expression Product that resulted from use of the rDNA technology, and found AquaAdvantage salmon are as safe to eat as conventional salmon. FDA used this analysis as part of its justification for rejecting FWW’s petition to have the salmon declared an unsafe adulterant.

In addition to the FDCA, FDA’s approval process is also subject to requirements under the National Environmental Procedure Act (NEPA) and Endangered Species Act (ESA). As required by their regulations, the FDA produced an environmental assessment (EA) of the likely impacts of the approval, and reached a Finding of No Significant Impact (FONSI).

Accompanying the EA, the FDA also carried out a Section 7 ESA consultation with relevant federal agencies (see pages 9-10 and 135-136 of EA).  In short, the company will be breeding sterile stock in conditions that, if they escaped, they would die, and then transporting and raising them in Panama where they would also be expected to die if they escaped. As a result of the FONSI, the agency does not have to prepare a full Environmental Impact Statement.  

Some might not think of NEPA or the ESA as “food laws,” because on their face they appear to be environmental laws. However, they are important components of administrative law to know of because they are far-reaching statutes that can significantly slow down, stop, or force repeal of agencies’ actions.

Students should note, the approval is only for production of the salmon under very specific conditions. If anyone wants to breed or raise the salmon in any other locale or method than FDA approved here, they would have to go through the NADA approval process again.

In addition to analyzing what the law is and how it works, lawyers and policy wonks ought to also talk about what goals or purpose the law should serve and whether and how it needs to be changed to achieve that goal.

One way to think about this is to ask, does the current approval process for GE foods properly balance risks and benefits? Factors one might want to consider are:
  • What are the major environment and health concerns and what data is needed to evaluate those concerns?
  • What would be the time and financial cost of collecting and analyzing data to support review? Are those costs worth it given the risks?
  • Who should be collecting and reviewing the data?
  • Is there adequate opportunity for all stakeholders’ input?
  • How will risks and benefits be distributed?

A hot botton issue related to the GE salmon approval is the labelling of GE foods. Accompanying the AquaAdvantage approval, FDA also issued final guidance on labelling foods derived from GE technologies and draft guidance on labelling Salmon.  

As you surely know, there are also several other labelling law issues pending across the country. Vermont’s legislation on the mandatory labelling of GE foods is facing a federal court challenge; a number of consumer class actions on ‘natural’ labelled GE foods are in state courts; FDA recently solicited comments on the use of the term natural in labelling GE foods (more on that in my next post); and the appropriations bill that Congress just released did not contain a hotly contested rider to preempt state GE labelling laws.

Are FDA’s voluntary labelling guidelines sufficient to overcome any issues raised by the earlier questions? If not, what kind of law or policy would be more effective? Why, and what are the possible implications of those alternative laws? For instance, Vermont's legislation raises the spectre of patchwork legislation that undermines the national uniformity of FDA labelling rules. This issue, and whether Vermont’s law is even legal, is an issue I will come back to in a few weeks with a post on some recent food law preemption cases.

* * *

If you would like to delve into the approval and regulations, the online GFLP offers two courses on biotech regulations: 810P Biotechnology Law and Food Products (2 credits) and 810N Survey of Intellectual Property in Agriculture (3 credits).

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