1. 1. Full Citation
Merrill, Richard A. "Food safety regulation: reforming the Delaney Clause." Annual review of public health 18.1 (1997): 313-340.


  1. 2. Where did/does the author work, what else has s/he written about, and what are her/his credentials?
    Richard Merrill is a Professor of Law Emeritus at the University of Virginia School of Law. He received his BA and MA degrees from Oxford University in 1961, and his LL.B. from Columbia University School of Law in 1964. He is an expert in administrative, environmental, and food and drug related law. In 1975 he served 2 years as chief counsel to the U.S. Food and Drug Administration.

  1. 3. What are the topics of the text?
    This article looks at the holes in the Delaney Clause, and ways the clause is causing issues in regulating the health and safety of food products.
  2. 4. What is the main argument of the text?
This text argues that the Delaney Clause and the policy based off of it, is restrictive and hazardous, as it limits the FDA and EPA’s actions. The text has a sub-argument against the strict administrative control over how regulatory bodies should act, as the micromanagement would bog down the process.


  1. 5. Describe 3 ways the argument is supported.
A review of the food and drug safety laws passed in the US is given to provide context and background on the current legislative atmosphere.
The chapter does a review of how the Delaney Clause made the FDA’s job more difficult by a section on the increase in carcinogenic substances and their process with dealing with it.


  1. 6. What three quotes capture the text?
    “This survey of food safety regulation is a peculiarly American story. It reflects both the cautious, incremental approach to problems that characterizes much US legislation and—increasingly—a distrust of administration.” P. 338

“The US Congress has retained for itself primary authority to decide not only how “safety” should be pursued, but what “safety” means.” P. 338

“r. I emphasize authorities and actions
aimed at purposeful “additives” to the food supply, and, correspondingly, focus
  • on efforts to identify and control potential chronic hazards to human health.” P. 315

  1. 7. Three questions about environmental risk and precaution?
    How much power should be given to individual institutions to decide on the best methods and definitions of risk control and analysis?
Is a centralized and universal definition of safety possible or beneficial?
What is the purpose of the Delaney Clause in modern regulation? Has it outgrown its usefulness?