The Food and Drug Administration (FDA) established a regulation that requires packaged juice products that are not pasteurized or otherwise processed to prevent, reduce or eliminate pathogens to carry a warning statement to inform consumers of the risk of foodborne illness to children, the elderly and persons with weakened immune systems. The warning statement had to be displayed by September 8, 1998, for apple juice and cider, and by November 5, 1998, for all other juices. The regulation states that juices that have been processed in a manner that achieves a 5-log (100,000 fold) reduction in pathogenic microorganisms are not required to bear the warning statement.
FDA is responding to manufacturers of fresh citrus juice who requested additional time beyond the November 5, 1998 compliance date to develop and validate procedures that will achieve the 5-log reduction standard in citrus juices.
In the preamble to the final rule, FDA stated its expectation that citrus juice processors should be able to achieve and validate a 5-log reduction without pasteurization (63 FR 37030 at 37042). FDA also indicated that it would be willing to meet with manufacturers or groups of manufacturers to discuss and evaluate their proposed processes. In addition, FDA stated that in order to help processors meet the pathogen reduction standard, the agency would make available, in accordance with part 20 of its regulations (21 CFR part 20), information received by the agency regarding processes that have been validated to achieve a 5-log reduction.
On September 18, 1998, FDA published a notice of availability of a guidance document entitled: "Warning and Notice Statement: Labeling of Juice Products Small Entity Compliance Guide," which contained questions and answers on how to comply with the juice labeling regulation. This guidance, however, did not provide specifics on how to achieve a 5-log reduction in pathogens. FDA is also aware of the widespread confusion among fresh citrus juice manufacturers as to how the agency expects them to achieve and validate the 5-log reduction. In light of this situation, FDA will conduct two technical scientific workshops in November. The first workshop will be held on November 12, 1998, at:
The Citrus Research and Education Center
University of Florida
Lake Alfred, Florida 33850
(941) 956-1151
The second workshop will be held on November 19, 1998, at:
FDA Los Angeles District Office
19900 MacArthur Boulevard, Suite 300
Irvine, California 90015-2486
(949) 252-7592
These workshops will provide industry representatives with an opportunity to share interventions and discuss strategies that have been developed for measuring and validating the 5-log reduction in citrus juice production. These workshops will also allow meeting participants an opportunity to pose technical questions to FDA experts.
Each of the technical scientific workshops are scheduled from 8:30 a.m. to 5:30 p.m. Registration for the workshops will be on a first come, first served basis and can be made by contacting Ms. Catherine M. DeRoever at the following address:
Center for Food Safety and Applied Nutrition (CFSAN) (HFS-22)
Food and Drug Administration
200 C St., SW
Washington, DC 20204
Telephone 202-205-4251
Fax 202-205-4970
e-mail "cderoeve@bangate.fda.gov"
Registration information (including name, title, firm name, address, telephone and fax numbers) must be received by Ms. DeRoever no later than November 6, 1998. If special accommodations are needed due to disability, please contact Ms. DeRoever at least 7 days in advance of the meeting. Meeting participants are requested to bring to the workshop at least 150 copies of any written or published materials that they wish to distribute at the workshop.
In addition, the agency has determined that it will suspend the enforcement of the final rule on a firm-by-firm basis and allow an additional 8-month period before packaged fresh citrus juices from such firms must carry a warning label. FDA's exercise of its enforcement discretion to grant additional time before warning labels are required to be displayed by citrus juice manufacturers is contingent on a firm agreeing, among other things, to develop, validate and implement a 5-log pathogen reduction process by July 8, 1999. The conditions are specified in more detail in the attached agreement.
Citrus juice manufacturers who want to request additional time to implement control measures and validate that the process achieves the necessary pathogen reduction may mail a completed copy of the attached agreement to the Director of the FDA District in which the firm is located no later than December 19, 1998. Copies of the agreement can be printed from the computer.
For firms in Florida, Texas, Arizona and California, the addresses are: Douglas Tolen, District Director, FDA Florida District Office, 555 Winderley Place, Suite 200, Maitland, Florida 32751, (407) 475-4700; Joseph Baca, District Director, FDA Dallas District Office, 3310 Live Oak Street, Dallas, Texas 75204, (214) 655-5315; or Elaine C. Messa, District Director, FDA Los Angeles District Office, 19900 MacArthur Blvd., Suite 300, Irvine, California 92612-2445, (949) 798-7714.
Terms of the Agreement
(1). The firm agrees to use the time granted to develop, adapt and validate procedures that achieve a 5-log reduction in the pertinent microorganism; and
(2). The firm agrees to establish interim protection measures in the form of a system that applies HACCP principles. This interim system will include, at a minimum, Good Manufacturing Practices, culling of damaged fruit, chemical washing, brushing and sanitizing of the fruit, and utilization of only those types of fruit with skins that are sufficiently smooth and durable to be cleanable and to remain intact after cleaning; and
(3) The firm agrees to comply with the requirement of the warning label regulation by July 8, 1999.
Name of Firm:_______________________________________
Firm Address:______________________________________
City, State, Zip Code:______________________________________
Telephone Number:______________________________________
Fax Number:______________________________________
Contact Person: (someone other than yourself that can act as a contact person for your firm if questions arise)
______________________________________The undersigned certifies that the above information is a true and accurate representation of the operations of ______________________________________(Name of firm). The undersigned understands that failure to comply with the terms of this agreement may result in FDA taking action (e.g., warning letter, detention, seizure of misbranded product, etc.) against the firm to enforce the warning statement regulation (21 CFR 101.17(g)) or otherwise to enforce provisions of the applicable law.
Signature______________________________________
Name (Type or clearly print)__________________________________
Title______________________________________
Date______________________________________
Docket # 97N-0524
Federal Register Notice October 28, 1998
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