Issue View | Council III | 2016 Scribe Packet
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Issue Number: Council III 027
This issue was submitted for consideration at a previous biennial meeting, see issue: 2014-III-27 ; the recommended solution has been revised .
Chemicals Used for Washing and Treating Fruits and Vegetables
Issue you would like the Conference to consider
A revision and clarification to the language of the 2013 Food Code, Section 7-204.12. The current language of Section 7-204.12 of the FDA Food Code Chemicals for Washing, Treatment, Storage and Processing Fruits and Vegetables, Criteria, does not:
- Differentiate between two categories of products, one chemical substance providing wash properties only and another substance with antimicrobial treatment properties.
- Allow for additionally approved antimicrobial treatment chemicals other than Ozone.
Washing chemicals (detergents) can be different than treatment chemicals (antimicrobials). Washing chemicals are typically rinsed off after use and do not carry antimicrobial claims. Many other treatment (antimicrobial) chemicals are not rinsed off after use and do carry claims to reduce, control, kill or treat microorganisms in/on Fruits and Vegetables or in wash water. The Food Code combines these uses in Section 7-204.12 and we recommend clearing up confusion and providing guidance for compliance and enforcement.
As technology advances, new methods to wash and treat produce are being developed. New treatment chemicals are being evaluated and cleared by FDA and registered with EPA, if applicable. Treatment chemicals used on fruits and vegetables can be under jurisdiction of FDA, EPA, or both, depending on the use and where the treatment occurs. The complexity of this jurisdiction and the lack of clear guidance may lead to the improper use of these chemicals some of which were not adequately reviewed by health and safety regulating agencies.
A decision tree is available from FDA (and could be included in the Food Code Annex if deemed appropriate) to help explain the EPA-FDA jurisdiction of antimicrobial substances entitled Determining Regulatory Authority of Antimicrobial Substances and found at the following link:
Lastly, the Food Code as it is currently written does not allow for antimicrobial treatment chemicals other than Ozone. There are many other antimicrobial chemicals on the market today that have been reviewed and cleared by FDA (and/or registered by EPA). The way the Food Code currently depicts Ozone as a treatment chemical in 7-204.12 suggests that Ozone is the only antimicrobial chemical treatment allowed. Moreover, an update would be needed to the Food Code (or Annex) each instance that a new treatment chemical (i.e. Sodium Dodecylbenzenesulfonate/SDBS in Annex 3) is cleared by FDA. Section 7-204.12 is not all inclusive and should be revised to allow for treatments chemicals other than Ozone without the need to update the Food Code each time new chemistry is developed and approved.
Public Health Significance
Per Annex 3 of the 2013 FDA Food Code- "If the chemical wash, boiler water additive, or drying agent used is not made up of components that are approved as food additives or generally recognized as safe, illness may result". This improper use of chemicals may also lead to public health issues such as food adulteration and recalls, and/or potentially acute and chronic health effects to both the consumer and the employees within the food retail facilities. The lack of clear and explicit guidance surrounding chemicals used for treating fruits and vegetables creates confusion, and allows for misinterpretation.
Recommended Solution: The Conference recommends...
that a letter be sent to FDA requesting the 2013 Food Code Section 7-204.12 Chemicals for Washing, Treatment, Storage and Processing Fruits and Vegetables, Criteria be modified as follows (language to be added is underlined; language to be deleted is in strikethrough format):
(A) Chemicals, including those generated on-site, used to wash or peel raw whole fruits and vegetables shall:
(1) Be an approved food additive listed for this intended use in 21 CFR 173, or
(2) Be generally recognized as safe (GRAS) for this intended use, or
(3) Be the subject of an effective food contact notification for this intended use (only effective for the manufacturer or supplier identified in the notification), and
(4) Meet the requirements in 40 CFR 16 Labeling Requirement for Pesticide and Devices.
Ozone, including those generated on-site, used as an antimicrobial agent used in the treatment, storage, and processing of fruits and vegetables in a food establishment shall: meet the requirements of 21 CFR 173.368 Ozone:
- Meet the requirements in 7-204.11 and 7-204.12 (A), and,
- Be appropriately cleared/registered by FDA or/and EPA and be used in accordance with the EPA - registered label use instructions, or manufacturer's instructions.