July 30, 2015

Modernization of the Coordinated Framework Governing Regulation of Genetically Engineered Organisms

As genetic engineering emerged from laboratories in the 1970’s into the biotechnology industry in the 1980’s, the possibility of government regulation arose, with a central question of whether a drug, for example, produced by genetic engineering rather than conventional chemical synthesis, required a distinct regulatory response. In another version of that same question: did a genetically modified plant require a distinct biotechnology regulatory treatment or could the plant fit into established oversight routes for plants produced through convention breeding techniques? In its most generic form, the debate that began in the 1980's wrestled with whether biotechnology processes produce inherently distinct products that demanded novel regulatory responses. According to the Coordinated Framework for the Regulation of Biotechnology announced by White House Office of Science and Technology Policy (OSTP) in 1986, the answer was generally no; a product or an engineered organism could be evaluated by the traditional agencies and laws that already existed to identify and manage risk. The coordinated framework thus divided the primary regulation of biotechnology products among three agencies – the Department of Agriculture’s Animal and Plant Health Inspection Service (APHIS), the Environmental Protection Agency (EPA), and the Food and Drug Administration (FDA). That scheme was updated in 1992, and that document continued to be the last word in regulatory design. Now the White House OSTP has announced that it will initiate a modernization of the 1992 policy. In a just-published memorandum to the three federal agencies, the OSTP first provides a definition of “biotechnology products” that will be the targets of the review:
For the purpose of this memo, “biotechnology products” refers to products developed through genetic engineering or the targeted or in vitro manipulation of genetic information of organisms, including plants, animals, and microbes. It also covers some of the products produced by such plants, animals, and microbes or their derived products as determined by existing statutes and regulations. Products such as human drugs and medical devices are not the focus of the activities described in this memo. 
In a briefing document on its blog, the OSTP has described the process ahead:
The goal of the effort is to ensure public confidence in the regulatory system and improve the transparency, predictability, coordination, and, ultimately, efficiency of the biotechnology regulatory system. Here is a bit more detail about the effort’s three components: 

First, the Administration will update the Coordinated Framework, after public input, by clarifying the current roles and responsibilities of the EPA, USDA, and FDA in the regulatory process. This update will help clarify which biotechnology product areas are within the authority and responsibility of each agency and outline how the agencies work together to regulate products that may fall under the authorities of multiple agencies. 

Second, the Administration will develop a long-term strategy, after public input, to ensure that the Federal regulatory system is well-equipped to assess efficiently any risks associated with the future products of biotechnology. This will include performing periodic horizon-scanning of new biotech products, coordinating support for the science that informs regulatory activities, developing tools to assist small businesses as they navigate the regulatory system, and creating user-friendly digital tools for presenting the agencies’ authorities, practices, and basis for decision-making. 

Third, the Administration will commission an outside, independent analysis of the future landscape of the products of biotechnology. The Administration has already asked the National Academies of Sciences, Engineering, and Medicine to conduct such an analysis. 
A modernized jurisdictional design could address some overlap between the responsible agencies, while also considering newer technologies and their placement into the scheme. For example, new organisms or products from the more recent field of synthetic biology might not fit the traditional category of “genetically engineered” which contemplated a small number of discrete and planned changes into an existing organism. A recent study from the Venter Institute on the regulatory challenges raised by synthetic biology endorsed the basic earlier principle that a product should be evaluated for its own discrete risk profile even when produced through synthetic biology; however, the  study notes that specific jurisdictional boundaries between the three federal agencies and specific legal authorities need to be updated to account for an expanding portfolio of genetic engineering modalities that will produce even more novel organisms than the first wave of genetic engineering.

July 23, 2015

Federal Bill to Preempt State GMO Labeling Laws Passes House and Heads for Senate

Today, the full House of Representatives passed H.R. 1599, the Safe and Accurate Food Labeling Act, by a vote of 275-150. The bill would amend the Federal Food, Drug, and Cosmetic Act regarding the FDA’s interaction with genetically engineered (GE) food products (often called genetically modified organisms, i.e., GMOs). The general purpose of the bill is to establish that GMO regulation should be managed at the federal level only. The bill was written to counter the most common form of state regulation of GMOs, namely, the state laws that mandate the labeling of GMO-derived food products. This includes the Vermont Act 120, scheduled to take effect in 2016, and the Maine and Connecticut laws which are conditional labeling mandates that are only triggered upon the passage of similar laws by neighboring states (see here). The bill contains an express preemption: 
(b) Prohibitions against mandatory labeling of food developed using genetic engineering.—No State or political subdivision of a State may directly or indirectly establish under any authority or continue in effect as to any covered product (as defined in section 291 of the Agricultural Marketing Act of 1946, as added by section 201 of this Act) in interstate commerce, any requirement for the labeling of a covered product indicating the product as having been produced from, containing, or consisting of a genetically engineered plant, including any requirements for claims that a covered product is or contains an ingredient that was produced from, contains, or consists of a genetically engineered plant unless the State (or a political subdivision thereof) establishes either of the following programs for the regulation of such claims...
The use and management of GMO crops and derived foods continues to be of great interest at the state legislative level. Here is the official summary of H.R. 1599
This bill amends the Federal Food, Drug, and Cosmetic Act to require the developer of a bioengineered organism intended as food to submit a premarket biotechnology notification to the Food and Drug Administration (FDA). A “bioengineered organism” (commonly called a “genetically modified organism” or “GMO”) is a plant or part of a plant that has been modified through recombinant DNA techniques in a way that could not be obtained using conventional breeding techniques.

The premarket notification must include the developer’s determination that food from, containing, or consisting of the GMO (GMO food) is as safe as a comparable non-GMO food. For the GMO to be sold as food, the FDA must not object to the developer’s determination. If the FDA determines that there is a material difference between a GMO food and a comparable non-GMO food, the FDA can specify labeling that informs consumers of the difference.

A food label can only claim that a food is non-GMO if the ingredients are subject to certain supply chain process controls. No food label can suggest that non-GMO foods are safer than GMO foods. A food can be labeled as non-GMO even if it is produced with a GMO processing aid or enzyme or derived from animals fed GMO feed or given GMO drugs.

The FDA must allow, but not require, GMO food to be labeled as GMO.

The FDA must regulate the use of “natural” on food labels.

This bill amends the Agricultural Marketing Act of 1946 to require the Agricultural Marketing Service to establish a program to certify non-GMO food.

This bill preempts state and local restrictions on GMOs or GMO food and labeling requirements for GMOs, GMO food, non-GMO food, or “natural” food. 
H.R. 1599 now goes to the Senate, which is not expected to take it up before September. Supporters of the bill are interested in preempting the wave of state attempts and successes at imposing mandatory labeling of GMO-derived foods and believe that Congress can finally shut down mandatory labeling through express preemption of state efforts. Supporters of mandatory GMO food labeling, knowing that the FDA has refused to impose a federal GMO labeling requirement for years, believe that state efforts constitute legitimate responses to consumer interest in GMO food labeling (most surveys note overwhelming support for labeling in the U.S). Although the conflict over product labeling has received the most attention, the bill has other particulars that define a more robust federal regulatory role – allowing the use of the term “natural” when food has GMO-derived content, specifying an acceptable pathway for manufacturers to claim “non-GMO”, and a possibly more general authority to regulate the use of GMO crops – for example, could planting bans on planting GMO crops that are enacted at a county level (see here) also be extinguished as the bill “preempts state and local restrictions on GMOs?” However, after several decades of state-based GMO labeling battles, H.R. 1599 appears to deliver a kind of nuclear option to these efforts, generally relying on a preemption analysis under the Supremacy Clause of the U.S. Constitution to nullify state laws. The state law battles have occurred because of the FDA's refusal to mandate the labeling of GMO food. One counter-measure that still remains at the federal level is an ongoing effort to require the FDA to impose a mandatory GMO labeling scheme at the federal level - see S.511, the Genetically Engineered Food Right-to-Know Act - but this bill has no chance, given the political realities manifest by the passage of H.R. 1599.