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U.S. Department of Health and Human Services

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Guidance for Industry: Standardized Training Curriculum for Application of HACCP Principles to Juice Processing; Final Guidance

Contains Nonbinding Recommendations

June 2003

Comments regarding this document may be submitted at any time to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. For questions regarding this document, contact Michael Kashtock at (301) 436-2022. (Updated phone: 240-402-2022)

U.S. Department of Health and Human Services
Food and Drug Administration
Center for Food Safety and Applied Nutrition
June 2003


Contains Nonbinding Recommendations

Guidance for Industry Standardized Training Curriculum for Application of HACCP Principles to Juice Processing
Final Guidance

The guidance represents FDA's current thinking on curricula for training juice processing personnel in the application of Hazard Analysis and Critical Control Point (HACCP) principles to juice processing. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such an approach satisfies the requirements of applicable statutes and regulations.

Purpose of the Guidance

The purpose of this guidance is to advise juice processors of FDA's view that the 1st Edition of the Juice HACCP Training Curriculum of the Juice HACCP Alliance (the standardized curriculum) is adequate for use in training individuals to meet the requirements of the juice HACCP regulation in 21 CFR 120.13. This guidance also advises processors and educators on how the requirements of the juice HACCP regulation may be met using the standardized curriculum or alternative curricula for training individuals and on how they can view, download, or purchase the standardized curriculum.

FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statuatory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.

What is the Standardized Curriculum?

The standardized curriculum is a curriculum that may be used to train individuals in the application of HACCP principles to the processing of juice. The curriculum was developed by the Juice HACCP Alliance (coordinated through the efforts of the National Center for Food Safety and Technology (NCFST) at the Illinois Institute of Technology), which was formed through the voluntary participation of industry, government, and academic members interested in guiding the juice industry to the higher level of food safety assurance provided by HACCP. Staff from the U.S. Food and Drug Administration participated as technical advisors in the development of the standardized curriculum.

Background

The juice HACCP regulation includes in 21 CFR 120.13 a requirement that individuals who perform certain specified functions, e.g., developing the hazard analysis or the HACCP plan, "shall have successfully completed training in the application of HACCP principles to juice processing at least equivalent to that received under standardized curriculum recognized as adequate by the Food and Drug Administration, or shall be otherwise qualified through job experience to perform these functions."

How Juice Processors May Meet the Requirements of 21 CFR 120.13

Juice processors may meet the requirement §120.13 by having affected employees, or consultants, undergo training using the standardized curriculum designated in this guidance. Processors are not required to have employees or consultants trained using the standardized curriculum. Other curricula may be used that are at least equivalent to the standardized curriculum in covering the application of HACCP principles to the processing of juice. FDA authorization to use an alternative curriculum is not required under the juice HACCP regulations. However, processors and educators considering the use of alternative curricula should evaluate the equivalency of the other curriculum by comparing it to the standardized curriculum and ensuring that a curriculum covers the following:

  1. Biological, chemical and physical hazards;
  2. Applicability of Current Good Manufacturing Practices and Sanitation Standard Operating Procedures;
  3. The 5 Preliminary Steps of HACCP with application to juice processing;
  4. The 7 Principles of HACCP with application to juice processing; and
  5. FDA's Juice HACCP Regulation (21 CFR Part 120) and related FDA guidance documents.

To View or Purchase the Standardized Curriculum

The standardized curriculum may be viewed and downloaded as a .pdf file free of charge at the website of the NCFST. Bound copies of the curriculum may be purchased from the NCFST as directed on the website.