The Federal Food Drug and Cosmetic Act contains many clauses that require scientific interpretation. In particular, there are a half dozen statutes that pertain to the safety of chemicals that may occur in food, and they are all different. How the laws are interpreted by the Food and Drug Administration to produce actual regulations also varies tremendously. The statutes used by the Environmental Protection Agency vary in many of the same ways. When done well, regulatory decisions are made that are at least arguably in the public interest. When done badly, a bureaucratic mishmash of science and policy results in a decision that no one really understands.
While this book touches on a wide variety of academic subjects, it is mostly written for political purposes: An audience of congressional staffers with an interest in agriculture, the environment, or science is envisioned. The law chapter is written for nonlawyers, the philosophy of science chapter is written for nonphilosophers, the regulatory policy chapters are written for nonbureaucrats, the toxicology chapters are written for nontoxicologists, and the chapters on quantitative risk analysis are written with as few numbers and equations as possible. Although the issues discussed all involve chemicals in food or the environment, the level of abstraction is usually high enough to be applicable to other issues, such as economics or global environmental issues, where scientific advice and public policy interact. As a result, the book may also be of some value to anyone with an interest in science, policy, or food.
Perhaps the whole book is just a blatant rip off of David Hume. Hume’s Fork appears in chapter 2, his Guillotine appears in chapter 4, the probability of the sun rising tomorrow is discussed in chapter 7, and I share his proclivity for burning nonsensical literary works in chapter 13. It may also be noted that the "dialogue" versions of the risk assessment paradigm discussed in chapter 4 effectively make reason a slave to the passions. Maybe I feel the need to do that because 21st century America isn't so different from 18th century England. So, even if I have merely translated A Treatise on Human Nature into modern dialect, it is well worth doing.
Contents:
Chapter 1: Food Law and Chemical Safety. The law defines safety in many different ways.
Chapter 2: Two Probabilities and Frequency Too. What is “probably true” is quite different from what will “probably happen”, which is different from how often something happens.
Chapter 3: The Safety Assessment Paradigm. A technocratic decision process commonly used by both FDA and the EPA to regulate chemicals in food and the environment.
Chapter 4: The Risk Assessment Paradigm. A democratic alternative, but be sure to distinguish “Is” from “Ought”.
Chapter 5: Dose-Response Theory. A bare-bones presentation of toxicological theory.
Chapter 6: Two Charades. The EPA risk assessment guidelines and the shell game explained. Final score: Technocracy 2, Democracy 0.
Chapter 7: The Sociology of Technocracy. Some of the academic roots of the shell game.
Chapter 8: The Wrong Probability. In epidemiology, it’s causality that matters, not statistical probability. That often seems to have been forgotten.
Chapter 9: A Practical Guide to Theoretical Probability. A properly weighted probability tree can break up technocratic impasses.
Chapter 10: The Paradigm War. Technocracy vs Democracy; a battle over fish consumption advisories.
Chapter 11: The Technocracide. Regulating arsenic and other contaminants: How to succeed and how to fail.
Chapter 12: Personal Technique. Science is subjective; accept no substitutes.
Chapter 13: Ending the Game. A list of solutions, some of which are legislatable.
Author mini-CV:
BA Psychology 1977 (U of Chicago)
PhD Pharmacology 1984 (Duke U)
Employed at USFDA Center for Food Safety and Nutrition 1989-2015
While this book touches on a wide variety of academic subjects, it is mostly written for political purposes: An audience of congressional staffers with an interest in agriculture, the environment, or science is envisioned. The law chapter is written for nonlawyers, the philosophy of science chapter is written for nonphilosophers, the regulatory policy chapters are written for nonbureaucrats, the toxicology chapters are written for nontoxicologists, and the chapters on quantitative risk analysis are written with as few numbers and equations as possible. Although the issues discussed all involve chemicals in food or the environment, the level of abstraction is usually high enough to be applicable to other issues, such as economics or global environmental issues, where scientific advice and public policy interact. As a result, the book may also be of some value to anyone with an interest in science, policy, or food.
Perhaps the whole book is just a blatant rip off of David Hume. Hume’s Fork appears in chapter 2, his Guillotine appears in chapter 4, the probability of the sun rising tomorrow is discussed in chapter 7, and I share his proclivity for burning nonsensical literary works in chapter 13. It may also be noted that the "dialogue" versions of the risk assessment paradigm discussed in chapter 4 effectively make reason a slave to the passions. Maybe I feel the need to do that because 21st century America isn't so different from 18th century England. So, even if I have merely translated A Treatise on Human Nature into modern dialect, it is well worth doing.
Contents:
Chapter 1: Food Law and Chemical Safety. The law defines safety in many different ways.
Chapter 2: Two Probabilities and Frequency Too. What is “probably true” is quite different from what will “probably happen”, which is different from how often something happens.
Chapter 3: The Safety Assessment Paradigm. A technocratic decision process commonly used by both FDA and the EPA to regulate chemicals in food and the environment.
Chapter 4: The Risk Assessment Paradigm. A democratic alternative, but be sure to distinguish “Is” from “Ought”.
Chapter 5: Dose-Response Theory. A bare-bones presentation of toxicological theory.
Chapter 6: Two Charades. The EPA risk assessment guidelines and the shell game explained. Final score: Technocracy 2, Democracy 0.
Chapter 7: The Sociology of Technocracy. Some of the academic roots of the shell game.
Chapter 8: The Wrong Probability. In epidemiology, it’s causality that matters, not statistical probability. That often seems to have been forgotten.
Chapter 9: A Practical Guide to Theoretical Probability. A properly weighted probability tree can break up technocratic impasses.
Chapter 10: The Paradigm War. Technocracy vs Democracy; a battle over fish consumption advisories.
Chapter 11: The Technocracide. Regulating arsenic and other contaminants: How to succeed and how to fail.
Chapter 12: Personal Technique. Science is subjective; accept no substitutes.
Chapter 13: Ending the Game. A list of solutions, some of which are legislatable.
Author mini-CV:
BA Psychology 1977 (U of Chicago)
PhD Pharmacology 1984 (Duke U)
Employed at USFDA Center for Food Safety and Nutrition 1989-2015
