Prevention as Cornerstone of FDA Food Safety Modernization Act

About 48 million people (1 in 6 Americans) get sick, 128,000 are hospitalized, and 3,000 die each year from foodborne diseases, according to recent data from the Centers for Disease Control and Prevention. This is a significant public health burden that is largely preventable.

The FDA Food Safety Modernization Act (FSMA), signed into law by President Obama on Jan. 4, enables FDA to better protect public health by strengthening the food safety system. It enables FDA to focus more on preventing food safety problems rather than relying primarily on reacting to problems after they occur.

Building a new food safety system based on prevention will take time, and FDA is creating a process for getting this work done. Congress has established specific implementation dates in the legislation. The funding the Agency gets each year, which affects staffing and vital operations, will affect how quickly FDA can put this legislation into effect. FDA is committed to implementing the requirements through an open process with opportunity for input from all stakeholders.

The following are among FDA’s key new prevention authorities and mandates. Specific implementation dates specified in the law are noted in parentheses:

For the first time, FDA will have a legislative mandate to require comprehensive, science-based preventive controls across the food supply. This mandate includes:

• Mandatory preventive controls for food facilities: Food facilities are required to implement a written preventive controls plan. This involves: (1) evaluating the hazards that could affect food safety, (2) specifying what preventive steps, or controls, will be put in place to significantly minimize or prevent the hazards, (3) specifying how the facility will monitor these controls to ensure they are working, (4) maintaining routine records of the monitoring, and (5) specifying what actions the facility will take to correct problems that arise. (Final rule due 18 months following enactment)
• Mandatory produce safety standards: FDA must establish science-based, minimum standards for the safe production and harvesting of fruits and vegetables. Those standards must consider naturally occurring hazards, as well as those that may be introduced either unintentionally or intentionally, and must address soil amendments (materials added to the soil such as compost), hygiene, packaging, temperature controls, animals in the growing area and water. (Final regulation due about 2 years following enactment)
  Authority to prevent intentional contamination: FDA must issue regulations to protect against the intentional adulteration of food, including the establishment of science-based mitigation strategies to prepare and protect the food supply chain at specific vulnerable points. (Final rule due 18 months following enactment)

Guidance and Rules

• Classification of Activities as Harvesting, Packing, Holding, or Manufacturing/Processing for Farms and Facilities
  Draft Guidance for Industry
  Docket Number: FDA-2016-D-2373
• Current Good Manufacturing Practice Requirements for Food for Animals
  Draft Guidance for Industry
  Docket Number: FDA-2016-D-1229
• Human Food By-Products for Use as Animal Food
  Draft Guidance for Industry
  Docket Number: FDA-2016-D-1220
• Draft Guidance: Hazard Analysis and Risk-Based Preventive Controls for Human Food
  Draft Guidance for Industry
  Docket Number: FDA-2016-D-2343
• Extension and Clarification of Compliance Dates for Certain Provisions of Four Implementing Rules
  Final Rule
  Docket Number: FDA-2011-N-0920, FDA-2011-N-0921, FDA-2011-N-0922, FDA-2011-N-0143
• Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food;Clarification of Compliance Date for Certain Food Establishments
  Final Rule
  Docket Number: FDA-2011-N-0920
• Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food
  Final Rule
  Docket Number: FDA-2011-N-0920
• Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals
  Final Rule
  Docket Number: FDA-2011-N-0922
• Sanitary Transportation of Human and Animal Food
  Final Rule
  Docket Number: FDA-2013-N-0013
• Mitigation Strategies to Protect Food Against Intentional Adulteration
  Final Rule
  Docket Number: FDA-2013-N-1425
• Draft Guidance: New Dietary Ingredient Notifications and Related Issues
  Draft Guidance for Industry
  Docket Number: FDA-2011-D-0376
• Fish and Fishery Products Hazards and Controls Guidance
  Guidance for Industry
  Docket Number: FDA- 2011-D-0287
• Preventive Controls for Registered Human Food and Animal Food/Feed Facilities
  Notice; Request for Comments
  Docket Number: FDA-2011-N-0238

Full Text of the Law Relating to Prevention

• SEC 101. INSPECTIONS OF RECORDS.
• SEC 102. REGISTRATION OF FOOD FACILITIES.
• SEC 103. HAZARD ANALYSIS AND RISK-BASED PREVENTIVE CONTROLS.
• SEC 104. PERFORMANCE STANDARDS.
• SEC 105. STANDARDS FOR PRODUCE SAFETY.
• SEC 106. PROTECTION AGAINST INTENTIONAL ADULTERATION.
• SEC 107. AUTHORITY TO COLLECT FEES.
• SEC 108. NATIONAL AGRICULTURE AND FOOD DEFENSE STRATEGY.
• SEC 109. FOOD AND AGRICULTURE COORDINATING COUNCILS.
• SEC 110. BUILDING DOMESTIC CAPACITY.
• SEC 111. SANITARY TRANSPORTATION OF FOOD.
• SEC 112. FOOD ALLERGY AND ANAPHYLAXIS MANAGEMENT.
• SEC 113. NEW DIETARY INGREDIENTS.
• SEC 114. REQUIREMENT FOR GUIDANCE RELATING TO POST HARVEST PROCESSING OF RAW OYSTERS.
• SEC 115. PORT SHOPPING.
• SEC 116. ALCOHOL-RELATED FACILITIES.

Training

Food Safety Preventive Controls Alliance
FDA, in cooperation with the Institute for Food Safety and Health, has created the Food Safety Preventive Controls Alliance to develop training courses and materials to help industry, particularly small- and medium-sized companies, comply with the upcoming preventive control rules.

Public Meetings and Webinars

• Final Rule on Mitigation Strategies To Protect Food Against Intentional Adulteration Webinar June 21, 2016
• Final Rule on Sanitary Transportation of Human and Animal Food Webinar April 25, 2016
• Preventive Controls for Human and Animal Food Final Rules October 20, 2015
• Final Rules on Preventive Controls: Webinar Series September 2015
• Proposed Rule on Focused Mitigation Strategies to Protect Food Against Intentional Adulteration and Proposed Rule on Sanitary Transportation of Human and Animal Food – Anaheim, CA March 13, 2014
• Proposed Rule on Focused Mitigation Strategies to Protect Food Against Intentional Adulteration and Proposed Rule on Sanitary Transportation of Human and Animal Food – Chicago, IL February 27, 2014
• Proposed Rule on Focused Mitigation Strategies to Protect Food Against Intentional Adulteration – College Park, MD February 20, 2014
• Proposed Rule to Establish Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals – Sacramento, CA December 6, 2013
• Proposed Rule to Establish Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals – Chicago, IL November 25, 2013
• Proposed Rule to Establish Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals – College Park, MD November 21, 2013
• Proposed Rules to Establish Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption and for Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food; Portland, OR
  March 27-28, 2013
• Proposed Rules to Establish Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption and for Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food; Chicago, IL March 11-12, 2013
• Proposed Rules to Establish Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption and for Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food; Washiongton, DC February 28-March 1, 2013

Speeches and Statements

• Prevention and Food Safety: Two Lenses, Common Vision
  Remarks at the George Washington University School of Public Health
  Washington, D.C.
  May 19, 2011

Reports

• Analysis of Results for FDA Food Defense Vulnerability Assessments and Identification of Activity Types
  This report is required under Section 106 of the FSMA.
  April 2013