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Letter Concerning Single Facility Requirement
Robert P. Parker, Esq.
Paul, Weiss, Rifkind, Wharton, & Garrison
1615 L Street, N.W.
Washington, D.C. 20036-7420
Re: Citizen Petition of the Florida Dept. of Citrus, et al concerning Juice HACCP
Dear Mr. Parker:
This letter reiterates the position of the Food and Drug Administration regarding the enforcement of the "single facility" requirement( 1 ) in the juice HACCP final rule( 2 ), which we discussed at our January 15 meeting.
On January 10, 2002, the Florida Department of Citrus, the Florida Citrus Processors Association, and the National Juice Products Association submitted a citizen petition( 3 ). The petition asked that FDA (1) amend the juice HACCP final rule to exempt processors of shelf-stable and concentrated juice products from the "single facility" requirement; and (2) stay the effective date of the requirement until the Agency had disposed of the citizen petition. The petitioners contend that transportation hazards (which the "single facility" requirement was designed to address( 4 )) could be adequately addressed as part of a processor's HACCP plan. Petition at p. 3-4. At our meeting, representatives of the Florida juice industry described in some detail the measures they represented are used widely by Florida juice concentrate producers to ensure that concentrates are not contaminated after processing when shipped to another facility for final packaging. The industry representatives argued that, in light of these measures, the "single facility" requirement is unnecessary for these producers.
Based in part upon this presentation and these representations, FDA has agreed to consider the exercise of enforcement discretion with respect to the "single facility" requirement as applied to producers and users of high °Brix juice concentrate( 5 ). FDA is considering the exercise of its discretion where the following three conditions are satisfied: (1) the producer and the user establish appropriate prerequisite and sanitation standard operating procedures (SSOPs) for the transport of high °Brix juice concentrate; (2) the producer and user designate as a critical control point (CCP) in their respective HACCP plans the transport of high °Brix concentrate from the production facility to a second facility for formulation and final packaging of concentrates; and (3) the producer and user establish control measures to prevent, reduce, or eliminate the risk of recontamination of the concentrate during transport( 6 ). The Agency expects that any producer of high °Brix juice concentrate whose HACCP plan does not designate such transport as a CCP and establish appropriate control measures will comply with the "single facility" requirement on the effective date of the final rule( 7 ).
As noted, the petition also requests that the final rule be amended to exempt producers of shelf-stable juices from the "single facility" requirement. In light of our January 15 discussion, FDA is considering the exercise of enforcement discretion only for the bulk transport and repackaging of shelf-stable single strength juice that is transported in aseptic packaging.
The agency intends to develop and promptly issue guidance that will contain FDA's basic recommendations for appropriate control measures for several transport modalities, including tankers, mobile tank farms within cargo ships, single-use sanitary containers (e.g., bag-in-box containers), and reusable containers with single-use liners (e.g., 55 gallon drums with single-use liners). In issuing this guidance, FDA will adhere to the Agency's Good Guidance Practices (GGPs), 21 CFR 10.115.
Please call me at 301-827-1137 or Catherine Copp of my staff at 301-827-1139 if you have any questions regarding the Agency's position. Technical questions should be directed to Terry Troxell, Ph.D., director of the Office of Plant and Dairy Foods and Beverages, Center for Food Safety and Applied Nutrition, at 202-205-4064.
Daniel E. Troy
- The relevant portion of the so-called "single facility" requirement provides that "Processors claiming an exemption under paragraph (a)(1) or (a)(2) of this section [which includes the juice concentrate producers in question] shall also process and perform final product packaging of all juice subject to the claimed exemption within a single production facility operating under current good manufacturing practices." 21 CFR 120.24 (c).
- 66 Fed. Reg. 6138 (January 19, 2001).
- Although the issues discussed at the January 15 meeting and in this letter are raised in the citizen petition, this letter is not a response to that petition. FDA will respond to the petition consistent with 21 CFR 10.30.
- See 66 Fed. Reg. at 6172-6173.
- High °Brix juice concentrate is a concentrate that is diluted and repackaged as either frozen orange juice concentrate for consumer use or as institutional concentrate.
- FDA does not intend to consider the exercise of its enforcement discretion for producers and users of high °Brix juice concentrates that are diluted to single strength and repackaged.
- The final rule has staggered effective dates for juice processors of various sizes. The rule is effective January 22, 2002, for all processors except small processors and very small processors, as defined in the regulation; the rule is effective January 21, 2003, for small processors, and January 20, 2004, for very small processors.