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Issue Number: Council III 027
Title
Issue you would like the Conference to consider
An update to the language of the 2013 Food Code, Section 7-204.12, to clarify the jurisdiction between the Food and Drug Administration (FDA) and the Environmental Protection Agency (EPA) with respect to the use of antimicrobials to treat fruit and vegetables. Chemicals used for washing, treatment, storage and processing fruits and vegetables have a very complex regulatory jurisdiction. The way the food code is currently written does not accurately depict this complex jurisdiction and has the potential to mislead industry into using unregulated chemicals on fruits and vegetables. This update would also help minimize confusion with field inspectors and all other regulators who work in this field and help ensure that a safer food product exists in the marketplace.
Public Health Significance
Some chemicals may be poisonous or toxic if not used properly and in accordance with the appropriate regulations and/or in accordance with the appropriate label instructions as dictated by the appropriate regulatory authority based upon the specific use. The lack of clear and explicit guidance surrounding chemicals used for treating fruits and vegetables not only creates confusion, but allows for misinterpretation. This can also lead to the improper use of chemicals and may subsequently cause public health issues such as food adulteration, or potentially acute and chronic health effects to both the consumer and the employees within the food facilities.
Recommended Solution: The Conference recommends...
that a letter be sent to the FDA requesting Section 7-204.12 of the 2013 FDA Food Code be amended as follows (new language is in underline format):
1) Amend Paragraph (A).
(A) Chemicals, including those generated onsite, used to wash, peel or treat raw, whole or processed fruits and vegetables shall:
(1) Be an approved food additive listed for this intended use in 21 CFR 173, P or
(2) Be generally recognized as safe (GRAS) for this intended use, P 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), P and
(4) Meet the EPA requirements in 40 CFR 156 Labeling
Requirements for Pesticide and Devices. P
(B) No changes.
2) Amend to Add New Paragraphs (C), (D), and (E).
(C) Chemicals used as antimicrobials for treating processed fruits and vegetables shall only have FDA clearance (no EPA registration needed) as specified in 7-204.12 (A).
(D) Chemicals used as antimicrobials for treating fruits and vegetables that are raw agricultural commodities (RACs) shall have EPA registration only (no FDA clearance needed) if the:
(1) Treatment of a RAC occurs when either applied in the field, at a facility that is not a food processing facility, or applied during transportation between the field and a food processing facility.
(E) Chemicals used as antimicrobials for treating fruits and vegetables that are raw agricultural commodities (RACs) shall have an EPA registration and an FDA clearance if the:
(1) Treatment of a raw agricultural commodity occurs in a food processing facility
(2) Treatment of the process water contacts the RAC or processed fruit and vegetable.