Guidance Documents and the Regulation of Genetically Modified Foods

Font Size:

Scholars argue that federal agencies should not use guidance documents to regulate controversial issues.

Font Size:

The development of genetically modified foods has prompted intense lobbying on all sides, from industry stakeholders to consumers—many of whom do not understand what science has to say about the practice of genetically engineering crops.

And the U.S. government may be making matters worse, according to two law professors.

Edward L. Rubin of Vanderbilt University Law School and Joanna K. Sax of California Western School of Law argue that the U.S. Food and Drug Administration (FDA) uses one of the most contentious regulatory techniques—the issuance of “guidance documents”—to govern one of the most controversial developments in food technology. Rubin and Sax say that these documents are too informal to effectively regulate the production of genetically modified foods, in part because guidance documents can be issued without adequate public participation.

They contend that FDA should instead follow the procedures in the Administrative Procedure Act (APA) to make regulations—not guidance documents. Not only would using the APA’s procedures make FDA policy on genetically modified foods more democratically legitimate, but it would also likely result in better policy.

FDA is not the only agency charged with regulating genetically modified foods—the U.S. Environmental Protection Agency regulates crops that are genetically engineered to withstand disease, and the U.S. Department of Agriculture (USDA) creates labeling requirements for genetically modified foods. Notably, last year USDA established new labelling standards for genetically modified foods after following the rulemaking procedures in the APA.

Rubin and Sax explain that, under the APA, federal agencies must provide the public with notice and take public comments when they issue new legally binding regulations. But when agencies publish guidance documents—claiming that their policies are merely interpretations of existing law instead of new binding rules—they can skip the procedures required by the APA.

Rubin and Sax maintain that FDA has chosen to rely exclusively on guidance documents to regulate whether—and under what conditions—companies can introduce genetically modified foods to the market. It is unclear, they contend, whether these FDA policies are merely interpretative rules that do not need to meet APA rulemaking requirements or new policies with binding legal power, which must go through the APA’s notice-and-comment process.

On the one hand, many of the policies in FDA’s guidance document do not stem from a congressional statute, suggesting that they are new binding rules, which require the agency to use APA procedures. On the other hand, FDA’s guidance may simply clarify the agency’s evaluation process for determining whether firms can market their genetically modified foods.

The line between interpreting existing rules and creating new binding rules is unclear, Rubin and Sax say.

When deciding whether to adhere to APA rulemaking procedures, Rubin and Sax suggest that regulators should focus on whether the general public, industry stakeholders, and other interested parties want to participate in the rulemaking process for a particular rule or have information that regulators may find useful. If a policy is sufficiently controversial—or if there is a broad public desire to participate—Rubin and Sax maintain that agencies should have to follow the APA’s notice-and-comment rulemaking requirements.

Applying this test of examining a policy’s importance or controversial nature, Rubin and Sax conclude that FDA should adhere to the APA’s notice-and-comment requirements when regulating genetically modified foods, as public and private stakeholders are interested in weighing in on this hotly contested issue.

Rubin and Sax also argue that using standard rulemaking procedures under the APA to regulate genetically modified food would result in better regulatory outcomes for two reasons.

First, the APA rulemaking procedures could raise awareness about the safety of genetically modified food. The scientific community agrees, Rubin and Sax explain, that genetically modified food does not pose a greater risk to public health and the environment than other selectively bred food products. But many consumers—39 percent of the public, according to one study—do not believe that genetically modified foods are safe for public consumption or for the environment.

Most people trust scientific conclusions about the safety of genetically modified foods, but the public simply does not know what the science says, Rubin and Sax argue.

By following the APA’s notice-and-comment rulemaking procedures, FDA may increase the level of public engagement in the rulemaking process and may ultimately raise public awareness about the safety of genetically modified food, according to Rubin and Sax. They theorize that even if most of the public does not engage directly with the notice-and-comment process, the debate over the FDA’s regulations could draw media attention, which could increase the public’s understanding of the issue.

FDA’s adherence to standard rulemaking procedures would also make it easier for smaller agricultural companies to compete with agricultural giants, Rubin and Sax argue. Under the current regulatory scheme, it can take ten years—and enormous sums of money—for companies to create new genetically modified products and bring them to the market. This costly system prohibits smaller companies from entering the industry.

Moreover, taking public comments would increase FDA’s exposure to more diverse viewpoints within the agricultural industry, which may lead to more balanced regulation of genetically modified foods in the future, Rubin and Sax contend. Currently, FDA has close working relationships with industry stakeholders from the largest agricultural companies, but the agency lacks input from smaller companies, say Rubin and Sax. In fact, Rubin and Sax speculate that FDA’s policies favor large, dominant companies over smaller players in part because smaller firms cannot advocate for their interests during a notice and comment process.

Ultimately, Rubin and Sax contend that FDA should level its policy playing field by following APA procedures and giving all stakeholders the opportunity to influence the regulation of genetically modified food.