“When should an agency use guidance versus rulemaking.”
This pivotal statement formed the central contention in a paper presented by California Western’s Prof. Joanna Sax at a recent Food and Drug Administration (FDA) Conference hosted by the American University College of Law and the Food and Drug Law Institute (FDLI) in Washington, D.C.
The paper, co-authored by Prof. Edward Rubin of Vanderbilt University Law School, entitled Administrative Guidance and Genetically Modified Food, discusses the use of guidance versus rulemaking in one of the most controversial areas in modern society: genetically modified (GM) food.
The conference, which covered every product area regulated by the FDA provided an opportunity for conversation between prominent practitioners, academics, and regulators with many of the FDA’s former commissioners and chief counsels present.
In her paper, Prof. Sax asserts that while agency officials generally maintain that they are using guidance to express an agency’s thoughts about how to comply with a specific statutory provision or agency rule, the practical consequence is that the regulated party will hesitate to disobey, even if it believes that the guidance goes beyond the requirements of the statute or rule.
“This is an ongoing issue in administrative law,” says Prof. Sax. “Rulemaking is a much more formal procedure because you get the participation of citizenry whereas guidance is just the agency’s thinking.”
Prof. Sax, who is widely recognized for her work on food policy, believes that the GM food area is an excellent example of where the FDA should issue a rule rather than guidance.
“The FDA regulates GM foods under guidance issued in 1992,” says Prof. Sax. “The guidance document is, I would argue, way over-inclusive as it creates this huge regulatory burden for GM food that isn't created for other food even though the science tells us there's no reason to overregulate one kind of food compared to another.”
Prof. Sax believes that one of the benefits of the FDA subjecting itself to the scrutiny of the rulemaking process is that it would allow the public and small biotech firms to enter the discussion in a meaningful way.
“GM food is a really complicated topic because the marketing against it has been so effective,” she says. “I don't think that the public really understands that we already eat genetically modified food and that the current molecular biology techniques do not in and of itself pose an added danger,” continues Prof. Sax. “Allowing smaller firms to enter the marketplace and adding a public participation component would be a mechanism to educate the public about the decades of science in this area.”
To read the full paper, Administrative Guidance and Genetically Modified Food, authored by Prof. Sax and Prof. Rubin visit: https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3175401