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Food Safety and Inspection Service
United States Department of Agriculture
Washington, D.C. 20250-3700

National Advisory Committee on
Microbiological Criteria For Foods (NACMCF)

Updated July 21, 2003

2002-2004 Subcommittee: Scientific Criteria for Redefining Pasteurization

Subcommittee Members

Dr. John Kvenberg, Working Group Chair
  • Dr. Larry Beuchat
  • Dr. Catherine Donnelly
  • Dr. Stephanie Doores
  • Dr. Daniel Engeljohn
  • Dr. Jeff Farrar
  • Dr. Lee-Ann Jaykus
  • Dr. Anna Lammerding
  • Dr. John Luchansky
  • Dr. Carol Maddox
  • Dr. Roberta Morales
  • Ms. Angela Ruple
  • Ms. Virginia Scott
  • Dr. Skip Seward
  • Dr. Katherine Swanson

Background and Work Charge (6-19-03): Requisite Scientific Parameters for Establishing the Equivalence of Alternative Methods of Pasteurization

The Farm Security and Rural Investment Act of 2002 (FSRIA) was signed into law on May 13, 2002 as Public Law 107-171. This law was passed to provide for the continuation of agricultural programs through 2007. FSRIA addresses commodity programs, conservation, trade, credit, rural development, research and related matters, forestry, energy, and miscellaneous items. Title X, Subtitle I, Section 10808(b) of FSRIA broadens the definition of pasteurization by mandating that Section 403 (h) (Misbranded Food) of the Federal Food, Drug, and Cosmetic Act (FFDCA) be amended to include a definition for pasteurization. Section 403 (h) reads as follows with the FSRIA amendment:

SEC. 403. [343] A food shall be deemed to be misbranded - …

(h) If it purports to be or is represented as -

(1) a food for which a standard of quality has been prescribed by regulations as provided by section 401, and its quality falls below such standard, unless its label bears, in such manner and form as such regulations specify, a statement that it falls below such standard;

(2) a food for which a standard or standards of fill of container have been prescribed by regulations as provided by section 401, and it falls below the standard of fill of container applicable thereto, unless its label bears, in such manner and form as such regulations specify, a statement that it falls below such standard; or

(3) a food that is pasteurized unless--

(A) such food has been subjected to a safe process or treatment that is prescribed as pasteurization for such food in a regulation promulgated under this Act; or

(B) (i) such food has been subjected to a safe process or treatment that--

(I) is reasonably certain to achieve destruction or elimination in the food of the most resistant microorganisms of public health significance that are likely to occur in the food;

(II) is at least as protective of the public health as a process or treatment described in subparagraph (A);

(III) is effective for a period that is at least as long as the shelf life of the food when stored under normal and moderate abuse conditions; and

(IV) is the subject of a notification to the Secretary, including effectiveness data regarding the process or treatment; and

(ii) at least 120 days have passed after the date of receipt of such notification by the Secretary without the Secretary making a determination that the process or treatment involved has not been shown to meet the requirements of subclauses (I) through (III) of clause (i).

We are seeking the advice of the National Advisory Committee on Microbiological Criteria for Foods (NACMCF) to determine appropriate requisite scientific parameters for establishing the equivalence of alternative methods of pasteurization. In order to do so, we have determined that the following questions deserve consideration.

  1. What are the scientific criteria that should be used to determine if a process is
    equivalent to pasteurization?
  2. What, if any, further research is needed to determine criteria?
  3. What is the most resistant microorganism of public health significance for each process?
  4. What data needs to be acquired to scientifically validate and verify the adequacy of a proposed technology? How much data would be considered adequate? To what degree can models and published literature be relied upon as contributing to validation?
  5. What biological hazards might be created as a consequence of the pasteurization treatment?

 

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For Further Information Contact:

Gerri Ransom
U.S. Department of Agriculture
Food Safety and Inspection Service
Office of Public Health and Science
Room 333, Aerospace Center
1400 Independence Ave., SW
Washington, DC 20250-3700
Phone: (202) 690-6600
Fax: (202) 690-6337
E-mail: gerri.ransom@fsis.usda.gov

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