Comments to the FDA on preventive controls for human food production

Lisa Heinzerling is the William J. Brennan, Jr., Professor of Law at Georgetown University Law Center. She is a former CPR Member Scholar.

Professor Heinzerling's specialties include environmental and natural resources law, administrative law, the economics of regulation, and food and drug law. From January 2009 to July 2009, she served as Senior Climate Policy Counsel to the Administrator of the Environmental Protection Agency and then, from July 2009 to December 2010, she served as Associate Administrator of EPA’s Office of Policy. In 2008, she served as a member of President Obama’s EPA transition team.

Heinzerling has been a visiting professor at Harvard Law School, Vermont Law School, and Yale Law School. She lectures frequently on environmental law and other topics both in the U.S. and around the world. She has published several books, including a leading casebook (with Zygmunt Plater and others) on environmental law, a cutting-edge casebook (with Mark Tushnet) aimed at introducing first-year law students to the regulatory and administrative state, and a widely cited critique of the use of cost-benefit analysis in environmental policy (Priceless: On Knowing the Price of Everything and the Value of Nothing, co-authored with Frank Ackerman). Peer environmental law professors have four times voted her work among the top ten articles of the year. In 2002, she received the faculty teaching award at Georgetown Law. The Yale Environmental Law Association and Yale Center for Environmental Law and Policy recently gave her their inaugural award for innovative and inspiring scholarship in environmental law.

After finishing law school, where she served as editor-in-chief of the University of Chicago Law Review, Professor Heinzerling clerked for Judge Richard A. Posner of the U.S. Court of Appeals for the Seventh Circuit and Justice William J. Brennan, Jr., of the U.S. Supreme Court. She was a Skadden Fellow at Business & Professional People for the Public Interest, in Chicago, and for three years practiced environmental law in the Massachusetts Attorney General's office.

While at Georgetown, Professor Heinzerling has continued to litigate cases in environmental law. Most prominently, she served as lead author of the winning briefs in Massachusetts v. EPA, in which the Supreme Court held that the Clean Air Act gives EPA the authority to regulate greenhouse gases. A 2009 survey of over 400 environmental lawyers and law professors ranked this case as the most significant case in all of environmental law.

Lisa Heinzerling
Georgetown University Law Center
Washington, DC
202.662.9115
email
website

Thomas O. McGarity holds the Joe R. and Teresa Lozano Long Endowed Chair in Administrative Law at the University of Texas in Austin. He is a member of the board of directors of the Center for Progressive Reform, and a past president of the organization.

Professor McGarity has taught and written in the areas of Administrative Law, Environmental Law, Occupational Safety and Health Law, Food Safety Law, Science and the Law, and Torts for twenty-five years.

While in academia, McGarity has served as a consultant and/or advisor to the Administrative Conference of the United States, the Office of Technology Assessment of the U.S. Congress (OTA), the U.S. Environmental Protection Agency, the U.S. Occupational Safety and Health Administration (OSHA), the Texas Department of Agriculture, and the Texas Natural Resource Conservation Commission. With Professor Sidney A. Shapiro, Professor McGarity designed and helped initiate a rulemaking prioritization process for OSHA rulemaking during the early 1990s. As a consultant to OTA, Professor McGarity helped write the "Regulatory Tools" report that agencies have frequently cited in designing regulatory programs. As a consultant to the Texas Department of Agriculture, McGarity was a primary draftsperson of that agency's first farmworker protection regulations in the late 1980s. During the mid-1990s, he was also actively involved in the drafting of and negotiations surrounding the federal Food Quality Protection Act.

Professor McGarity began his legal career in the Office of General Counsel of the Environmental Protection Agency. In the private sector, Professor McGarity has served as counsel or consultant in various legal and administrative proceedings to the Natural Resources Defense Council, Public Citizen, the Sierra Club, the American Lung Association, the National Audubon Society, Texas Rural Legal Aid, California Rural Legal Aid, and many local organizations, including, for example, The Bear Creek Citizens for the Best Environment Ever. McGarity has also served on many advisory committees for such entities as the U.S. Environmental Protection Agency, the Office of Technology Assessment, and the National Academy of Sciences.

Professor McGarity has published widely in the areas of regulatory law and policy. His book Reinventing Rationality analyzes the advantages and disadvantages of cost-benefit analysis in regulatory decision-making and describes the use of such regulatory impact assessments by federal agencies and the Office of Management and Budget during the Reagan Administration. Workers at Risk, co-authored with Sidney A. Shapiro, describes rulemaking, implementation and enforcement in the Occupational Safety and Health Administration from its inception in 1970 through 1990. The book then analyzes OSHA's strengths and weaknesses and makes many recommendations for improving standard-setting and enforcement. McGarity's casebook, The Law of Environmental Protection, co-authored with John Bonine, has been used in introductory Environmental Law courses at law schools throughout the country. His relatively recent books include The Preemption War: When Federal Bureaucracies Trump Local Juries, Yale University Press 2008, and Bending Science: How Special Interest Corrupt Public Health Research, Harvard University Press 2008, co-authored with fellow CPR Member Scholar Wendy Wagner.

Professor McGarity has published dozens of articles on environmental law, administrative law, and toxic torts in prominent law reviews, such as the Harvard Law Review, Chicago Law Review, Pennsylvania Law Review and Law & Contemporary Problems, as well as in specialty journals, such as the Administrative Law Review, the Harvard Environmental Law Review, Risk, and the Kansas Journal of Law & Public Policy, and consumer magazines like the American Prospect and the Hastings Center Report. McGarity has written on federal regulation of biotechnology since the advent of the commercialization of recombinant DNA techniques, and his article in the Duke Law Journal on the "ossification" of the federal rulemaking process, which elaborates on the dangers of encumbering the process of promulgating health and environmental rules with burdensome analytical requirements and review procedures, is frequently cited in the recurrent "regulatory reform" debates.

Professor McGarity has been an active participant in efforts to improve health, safety and environmental quality in the United States. He has testified before many congressional committees on environmental, administrative law, preemption of state tort laws in cases involving medical devices, and occupational safety and health issues. During the first session of the 104th Congress (the "Gingrich" Congress), Professor McGarity was frequently the lone representative of the view that federal regulation had an important role to play in protecting public health and the environment on panels testifying before House and Senate Committee considering "regulatory reform" legislation. Professor McGarity has also participated in path-breaking legal challenges to government inaction like Environmental Defense Fund v. Blum (a challenge to EPA's decision to allow further use of the carcinogenic pesticide mirex through emergency use exemptions) and Les v. Reilly (a challenge to EPA's failure to establish protective tolerances for eight carcinogenic pesticides). As a result of the latter litigation, the pesticide industry was forced to accept the greater protections afforded children in the Food Quality Protection Act of 1996. 

Thomas McGarity
The University of Texas School of Law
Austin, TX
512.232.1384
email
website

Sidney A. Shapiro holds the Fletcher Chair in Administrative Law at the Wake Forest University School of Law and is the Associate Dean for Research and Development. He is a member of the board of directors of the Center for Progressive Reform.

Professor Shapiro has taught and written in the areas of Administrative Law, Regulatory Law and Policy, Environmental Policy, and Occupational Safety and Health Law for 25 years.

While in academia, Shapiro has served as a consultant to the Administrative Conference of the United States (ACUS), the Office of Technology Assessment of the U.S. Congress (OTA), and the U.S. Occupational Safety and Health Administration (OSHA). With Professor Thomas O. McGarity, Professor Shapiro designed and helped initiate a rulemaking prioritization process for OSHA rulemaking during the early 1990s. As a consultant to OTA, Professor Shapiro assessed various regulatory tools or options that agencies can use to implement regulation. As a consultant to ACUS, Professor Shapiro studied the efficacy of the regulatory process at EPA (noise control), OSHA, and the Food and Drug Administration (FDA).

Professor Shapiro began his legal career as a trial attorney in the Bureau of Competition of the Federal Trade Commission and later worked as the Deputy Legal Counsel, Secretary's Review Panel on New Drug Regulation at the Department of Health, Education and Welfare.

Professor Shapiro has published widely in the areas of regulatory law and policy. He co-authored The People’s Agents and the Battle to Protect the American Public: Special Interests, Government, and Threats to Health, Safety, and the Environment, with CPR President, Rena Steinzor. This book reviewed years of government actions and inactions leading to the decline of the five protector agencies. His book, Risk Regulation at Risk: Restoring a Pragmatic Approach, analyzes health and safety and environmental protection laws and policy, and argues for a pragmatic approach to policy in these areas instead of using economic analysis to set regulatory goals. Workers at Risk, co-authored with Thomas O. McGarity, describes rulemaking, implementation and enforcement in the Occupational Safety and Health Administration from its inception in 1970 through 1990. The book analyzes OSHA's strengths and weaknesses and makes many recommendations for improving standard-setting and enforcement. Shapiro's casebook, Administrative Law and Procedure: A Problem Approach, co-authored with William Funk and Russell Weaver, is used in administrative law courses at law schools throughout the country. His casebook, Regulatory Policy and Law, is the first of its kind, and is used to train lawyers to evaluate and advocate for public policy.

Professor Shapiro has published dozens of articles on regulatory policy, health and safety laws, environmental law and administrative law in prominent law reviews, such as the Harvard Law Review, Duke Law Journal and the Wake Forest Law Review, as well as in specialty journals, such as the Administrative Law Review and the Ecology Law Quarterly.

Professor Shapiro has been an active participant in efforts to improve health, safety and environmental quality in the United States. He has testified before congressional committees on administrative law and occupational safety and health issues. He has worked with various public interest groups in advisory and support capacities, including Public Citizen Global Trade Watch, Public Citizen Congress Watch, and OMB Watch. 

Sidney Shapiro
Wake Forest University School of Law
Winston-Salem, NC
336.758.7320
email
website

Rena Steinzor is the Edward M. Robertson Professor of Law at the University of Maryland Francis King Carey School of Law, and a past president of the Center for Progressive Reform. She is the author of Why Not Jail? Industrial Catastrophes, Corporate Malfeasance, and Government Inaction.

Professor Steinzor has taught an environmental law survey course, seminars in risk assessments and critical issues in environmental law and science, administrative law, contracts, torts and counseling and negotiation. She has written in the areas of (1) regulatory dysfunction in agencies assigned to protect public health, worker and consumer safety, and the environment; (2) the role of centralized White House review on the protectiveness of regulation; (3) environmental federalism, including so-called "unfunded mandates" imposed on state and local governments by the federal government and the impact on public health of devolving authority and responsibility for solving environmental problems; (4) the implications of industry self-regulation on the protection of the environment and human health; (5) "market-based" alternatives to traditional regulation; and (6) political interference with regulatory science.

She is the editor, with Christopher Schroeder, of the CPR-sponsored book A New Progressive Agenda for Public Health and the Environment, published by Carolina Academic Press. She is also the editor, with Wendy Wagner, of the book Rescuing Science from Politics, published by Cambridge University Press in 2006. Her book, Mother Earth and Uncle Sam: How Pollution and Hollow Government Hurt Our Kids was published by the University of Texas Press in December 2007. With Professor Sidney Shapiro of Wake Forest Law School, she co-authored The People’s Agents and the Battle to Protect the American Public: Special Interests, Government, and Threats to Health, Safety, and the Environment published by the University of Chicago Press in 2010.

Professor Steinzor began her legal career in 1976, and entered academia in January 1994. From 1987 through 1993, she was associated - first as "of counsel" and ultimately as the partner in charge of the environmental practice - at Spiegel & McDiarmid, a 45-lawyer, Washington, D.C. firm representing approximately 400 cities, counties, states, and public agencies in the energy, environmental, communications, and transportation fields. The practice counseled federal, state, and municipal clients regarding compliance with federal and state laws and regulations.

Prior to joining Spiegel & McDiarmid, Professor Steinzor served as Staff Counsel, Subcommittee on Commerce, Transportation, and Tourism of the Energy and Commerce Committee, U.S. House of Representatives (James J. Florio, Chairman). She was the primary staff person responsible for legislation that became the "Superfund Amendments and Reauthorization Act of 1986" (Public Law 99-499) and the "Asbestos Hazard Emergency Response Act" (Public Law 99-519). She also prepared legislation to reauthorize the Toxic Substances Control Act during the 98th Congress.

Professor Steinzor has testified before Congress on several occasions, most recently regarding the impact of health, safety, and environmental regulations on the economy.

Rena Steinzor
University of Maryland Carey School of Law
Baltimore, MD
410.706 0564
email
website

Michael Patoka, J.D., joined the Center for Progressive Reform as a Policy Analyst in October 2012. He previously interned with CPR during law school, co-authoring an extensive report on the Office of Information and Regulatory Affairs (OIRA) and its politicization of the regulatory process, as well as an article based on the report that was published in The Environmental Forum. As a summer research assistant to CPR President Rena Steinzor, he co-authored a set of comments detailing how OIRA undermined the EPA’s proposal to regulate toxic coal ash and critiquing the cost-benefit analysis that emerged from OIRA’s review.

Mr. Patoka graduated summa cum laude from the University of Maryland Baltimore County (UMBC) with a B.S. in Computer Science. He received his law degree from the University of Maryland Francis King Carey School of Law, where he graduated summa cum laude and was awarded the William Strobel Thomas Prize for achieving the highest scholastic average of the Class of 2012. As a student attorney in the law school’s Drug Policy Clinic, he successfully persuaded several large employers to bring their benefits into compliance with the Mental Health Parity and Addiction Equity Act and developed tools to help health care providers identify and pursue parity violations.

Contact information: email 202.747.0698