Backgrounder: Unpasteurized Juice
SEATTLE - On August 28, 1997, the FDA published a notice of intent that would require all unpasteurized or untreated juices to be labeled with a warning statement. Despite numerous comments in protest to the proposal as written, President Clinton announced the publication of a final rule on July 4, 1998, and the FDA published the rule on July 8, 1998.
In addition to the numerous food safety advocacy groups who filed protests, the National Food Processing Association harshly condemned the rule for failing to “fully protect consumers.” It is (and was) the NFPA’s position that all fruit and vegetable juices should be pasteurized.
Despite the fact that the rule was already considered too lenient, on October 23, 1998, the FDA announced granting an 8-month extension to citrus juice manufacturers who meet certain FDA requirements. This meant that retailers who wished to sell unpasteurized citrus juice had three options to consider to comply with warning label regulations on unpasteurized juice.
The options were:
OPTION 1: TO SELL UNPASTEURIZED JUICE WITH A WARNING LABEL ON CONTAINER OR DISPLAYED ON SIGN OR PLACARD.
Unpasteurized citrus juice may be sold provided the warning label is on the container, or displayed on a sign or placard. The warning must be in place by November 5, 1998. The warning for citrus juice is the same as the label on apple juice and apple cider, which went into effect on September 8, 1998.
OPTION 2: TO PURCHASE FROM A SUPPLIER WHO HAS BEEN GRANTED AN 8-MONTH EXTENSION BY FDA.
If a retailed purchased unpasteurized citrus juice from a supplier who met the FDA conditions announced on October 23, 1998, (the requirements are detailed below under Option 3), a retailer could display and sell the juice without the warning label, signs or placards. However, a retailer was still required to obtain a copy of the suppliers’ letter to FDA for its file, and thus be able to demonstrate that the juice manufacturer was meeting the FDA conditions. This letter, which indicates that the manufacturer has registered a request for an extension with FDA, had to be postmarked by December 19, 1998.
OPTION 3: TO PRODUCE AND SELL UNPASTEURIZED JUICE AT RETAIL WITHOUT WARNING LABEL, SIGN OR PLACARD, UNDER SPECIFIC CONDITIONS ANNOUNCED BY THE FDA.
Retailers may produce and sell unpasteurized citrus juice (i.e., like they do at grocery stores, running their own juice squeezing machine) without the warning label, sign or placard only if the retailer could meet the specific conditions announced by FDA on October 23, 1998. To comply, the retailer must register a request for an extension with FDA, in writing, by December 19, 1998. In this letter, the retailer was required to indicate its willingness to comply with three specific conditions:
- to use the 8-month extension to develop, adapt and validate procedures that will achieve a 5-log (100,000 fold) reduction in pertinent pathogens;
- to establish interim protection measures, using HACCP principles, to identify and correct procedures where a potential food safety hazard might occur. These measures should include, at a minimum, controls for washing and sanitizing fruit, culling damaged fruit, and using only fruit with skins that are cleanable and remain intact; and
- to use the warning label on your products beginning July 8, 1999 if a process resulting in a 5-log pathogen reduction has not been achieved and validated by that date.
A copy of the letter that the retail-producer sent to FDA and other pertinent materials, such as Good Manufacturing Practices (or GMP’s) and other control measures being used to assure safe production of the juice, should have been kept on file and readily available to document that the retail-producer had registered with FDA for the extension, and that it was complying with the conditions set forth in the letter.