Irradiation of Food and Food Packaging

Overview

The U.S. Food and Drug Administration (FDA) is responsible for regulating the use of irradiation in the treatment of food and food packaging. This authority derives from the 1958 Food Additives Amendment to the Federal Food, Drug, and Cosmetic Act (FD&C Act) where Congress explicitly defined a source of radiation as a food additive (Section 201(s) of the FD&C Act). The 1958 Food Additives Amendment also provides that a food is adulterated (that is, it cannot be marketed legally) if it has been irradiated, unless the irradiation is carried out in conformity with a regulation prescribing safe conditions of use (Section 403(a)(7) of the FD&C Act). Thus, FDA regulates the lawful use of irradiation through the food additive petition process, the completion of which results in the promulgation of a regulation published in the Federal Register prescribing the approved use.

This Internet site is intended to serve as a source of general as well as more specific regulatory and scientific information about the irradiation of food and packaging for consumers, representatives from industry, and other stakeholders.

Background

• Irradiation of Food - An FDA Perspective 1986 (PDF, 2.63MB)
• Irradiation of Food and Packaging: An Overview 2004
• Irradiation of Prepackaged Food: Evolution of the U.S. Food and Drug Administration's Regulation of the Packaging Materials 2004
• Packaging for Foods Treated with Ionizing Radiation 2007

Consumer Information

• Irradiaton: A Safe Measure for Safer Iceberg Lettuce and Spinach August 22, 2008
• Food Irradiation: A Safe Measure January 2000
• Irradiation and Food Safety: Answers to Frequently Asked Questions (FSIS, September 2005)

Industry Information

• U.S. Regulatory Requirements for Irradiating Foods May 1999
• Memorandum of Understanding: Listing or Approval of Food Ingredients and Sources of Radiation Used in the Production of Meat and Poultry Products (FDA/FSIS) January 2000
• FDA Broadens Use of Packaging Materials for Irradiation of Prepackaged Foods February 16, 2001
• Irradiation of Food Packaging Materials
  (From Food Safety Magazine December 2007/January 2008)

Selected Federal Register Documents

• August 22, 2008: Irradiation in the Production, Processing and Handling of Food; Final Rule
  • Questions and Answers about Final Rule on Irradiation of Fresh Iceberg Lettuce and Fresh Spinach August 21, 2008
• April 4, 2007: Irradiation in the Production, Processing and Handling of Food; Proposed Rule
• August 16, 2005: Ionizing radiation for control of Vibrio species and other foodborne pathogens in fresh or frozen molluscan shellfish
• October 2000: Ionizing radiation to control microbial pathogens in seeds for sprouting
• July 21, 2000: Ionizing radiation for the reduction of Salmonella in fresh shell eggs
• December 3, 1997: Radiation to treat refrigerated or frozen uncooked meat, meat byproducts, and certain meat food products

Guidance and Regulations

• Guidance on the Petition Process to Request Approval of Labeling for Foods Treated By Irradiation October 2002
• Irradiation in the Production, Processing and Handling of Food
  (Regulations published in 21 CFR part 179)
• Microbiological Considerations for Antimicrobial Food Additive Submissions June 2008

Levels of Irradiation for Foods and Packaging Materials

• Table of Allowable Dose Levels of Irradiation in Foods Permitted to be Irradiated Under FDA's Regulations (21 CFR 179.26)
• Table of Packaging Materials with Allowable Dose Levels of Radiation for Use During Irradiation of Prepackaged Foods (21 CFR 179.45)

Related Links

• Federal, State and Local Government Web Sites