1 Chapter 2 – Organization of Food Law 1 Chapter 2 – Organization of Food Law

1.1 Forms of Food Law 1.1 Forms of Food Law

1.2 Government Regulation: Public Health and Safety Laws and Consumer Protection 1.2 Government Regulation: Public Health and Safety Laws and Consumer Protection

1.2.1 Fragmentation 1.2.1 Fragmentation

1.2.2 Food and Drug Administration (FDA) 1.2.2 Food and Drug Administration (FDA)

1.2.2.1 Regulatory Activity 1.2.2.1 Regulatory Activity

1.2.2.2 Administrative Adjudication 1.2.2.2 Administrative Adjudication

1.2.2.3 Formal Rulemaking 1.2.2.3 Formal Rulemaking

1.2.2.4 Informal Rulemaking 1.2.2.4 Informal Rulemaking

1.2.2.5 Informal Guidance 1.2.2.5 Informal Guidance

1.2.2.6 Informal and Public and Private Meetings 1.2.2.6 Informal and Public and Private Meetings

1.2.2.7 Citizen Petitions 1.2.2.7 Citizen Petitions

1.2.2.8 Additional Petitions and Tools 1.2.2.8 Additional Petitions and Tools

1.2.2.9 Enforcement 1.2.2.9 Enforcement

1.2.3 Food Safety Inspection Service (USDA) 1.2.3 Food Safety Inspection Service (USDA)

1.2.4 Environmental Protection Agency (EPA) 1.2.4 Environmental Protection Agency (EPA)

1.2.5 Federal Trade Commission (FTC) 1.2.5 Federal Trade Commission (FTC)

1.2.5.1 Food Safety Modernization Act 1.2.5.1 Food Safety Modernization Act

The 2011 Food Safety Modernization Act (FSMA) ushered in a new federal food safety regime.  After a series of disease outbreaks in the United States were linked to foods like carrot juice, peanut butter, bagged spinach, pepper, cookie dough, and even dog food, consensus grew that legal and policy change was needed.  Although there was no shortage of disagreement on particulars, consumers, producers, activists, and politicians all agreed on the need for change.  One of FSMA’s key principles is an emphasis on prevention.  To oversimplify a bit, in the old regime agencies would use establishment-by-establishment inspections to detect safety risks and then use warning letters and enforcement actions to bring the wrongdoers into compliance.  Given the number of establishments, the number of inspectors, and resources available to federal inspectors, truly protecting food safety with intermittent inspections is all but impossible.  FSMA’s so-called risk-based approach seeks to focus regulatory attention on the points in the production and distribution of food most likely to produce safety problems and to require ex ante development of hazard management plans by each food producer.    

1.2.6 State Law Enforcement Authorities 1.2.6 State Law Enforcement Authorities

1.2.7 Calls for Single Food Agency 1.2.7 Calls for Single Food Agency

1.3 Government Programs 1.3 Government Programs

1.3.1 USDA Mission 1.3.1 USDA Mission

1.3.2 US Farm Bill 1.3.2 US Farm Bill

1.3.3 Delineation of USDA Programs 1.3.3 Delineation of USDA Programs

1.4 Global Governance of Food 1.4 Global Governance of Food

1.4.1 Dynamic System of Systems 1.4.1 Dynamic System of Systems

1.4.2 Framework for Global Food Governance 1.4.2 Framework for Global Food Governance

1.4.2.1 Trade Rounds and the World Trade Organization 1.4.2.1 Trade Rounds and the World Trade Organization

1.4.2.2 Legal Instruments 1.4.2.2 Legal Instruments

1.4.3 Relevant Organizations 1.4.3 Relevant Organizations

1.4.3.1 Food and Agricultural Organization (FAO) 1.4.3.1 Food and Agricultural Organization (FAO)

1.4.3.2 World Health Organization (WHO) 1.4.3.2 World Health Organization (WHO)

1.4.3.3 Codex Alimentarius Commission 1.4.3.3 Codex Alimentarius Commission

1.4.3.4 World Organization for Animal Health (OIE) 1.4.3.4 World Organization for Animal Health (OIE)

1.4.3.5 Additional Organizations 1.4.3.5 Additional Organizations

1.4.4 Standard Setting Process and Application 1.4.4 Standard Setting Process and Application

1.4.5 European Food Law 1.4.5 European Food Law

1.5 Self-Governance 1.5 Self-Governance

1.5.1 Theoretical Underpinnings 1.5.1 Theoretical Underpinnings

1.5.2 New Governances Approaches 1.5.2 New Governances Approaches

1.5.3 Defining Characteristics of New Governance Forms of Law 1.5.3 Defining Characteristics of New Governance Forms of Law

1.5.4 Concerns of New Governance 1.5.4 Concerns of New Governance

1.6 Municipal Law 1.6 Municipal Law

1.6.1 Police Power 1.6.1 Police Power

1.6.2 Assistance to Federal Regulation 1.6.2 Assistance to Federal Regulation

1.6.3 Laboratories for Innovation 1.6.3 Laboratories for Innovation

1.6.4 Preemption Considerations 1.6.4 Preemption Considerations

1.7 Litigation 1.7 Litigation

1.7.1 Legal Tool 1.7.1 Legal Tool

1.7.2 No Private Right of Action 1.7.2 No Private Right of Action

1.7.3 Administrative Procedure Act 1.7.3 Administrative Procedure Act