Mike Montemarano, Associate Editor 03.02.21
The American Herbal Products Association (AHPA), a trade association representing the herbs and botanicals industry, recently submitted comments to the FDA on its proposed rule expanding traceability requirements for a number of food categories, including fresh herbs, which are on the FDA’s Food Traceability List (FTL).
The new rule implements a Congressional directive from the Food Safety Modernization Act (FSMA), to require additional recordkeeping for foods that the FDA designates as “high risk.” Among the foods on the FTL include “herbs (fresh)” including examples of parsley, cilantro, and basil, and under the proposed rule, these products would need a lot-specific “traceability lot code,” and finished products containing these ingredients would be required to have the same codes. This code would then follow the lot through the entire supply chain until the lot enters retail sale, and these recordkeeping requirements would be applied to every processor, manufacturer, and handler of these products throughout the supply chain.
“The risk ranking model used by the agency to develop the tentative FTL does not appear to support the need for additional traceability records of all plants that are described as or known as ‘herbs.’ AHPA believes that FDA did not, in fact, intend to assert that the results of the model identified ‘all types of herbs’ as subject to the additional traceability records envisioned by and required by section 204 of FSMA,” Michael McGuffin, AHPA president, said. “Rather, it instead appears that FDA intended to identify only fresh culinary herbs, such as those included in the above-quoted description, for inclusion in the tentative FTL and therefore as subject to the requirements of the rule. AHPA therefore requests that FDA revise the FTL upon issuance of the final rule to specifically identify ‘culinary herbs (fresh).’”
AHPA’s concerns are that a number of low-risk herbs used in dietary supplements, which have exceedingly rare instances of adverse events compared to culinary herbs which are subject to less, if any, processing. For this reason, AHPA requested that the FDA specifically amend the FTL to include culinary herbs.
AHPA’s comments also note that the FTL does not provide specific definitions, and requests that the final rule defines specific commodities, or plant parts, within the rule to provide clear guidance to the industry. AHPA also requested additional consistency in terms of the procedures by which the FDA adds or removes foods from the FTL.
The comments also include an addenda, in which AHPA requested again that the FDA reevaluate the Produce Safety Rule’s expansive definition of “produce” to place it in line with Congressional intent, and requested a number of reformations to the list of produce rarely consumed raw (the RCR list). Commodities on the RCR list are exempt from the proposed recordkeeping requirements. AHPA is among multiple trade associations which have requested that the FDA consider further engaging stakeholders on its proposed rule.
The new rule implements a Congressional directive from the Food Safety Modernization Act (FSMA), to require additional recordkeeping for foods that the FDA designates as “high risk.” Among the foods on the FTL include “herbs (fresh)” including examples of parsley, cilantro, and basil, and under the proposed rule, these products would need a lot-specific “traceability lot code,” and finished products containing these ingredients would be required to have the same codes. This code would then follow the lot through the entire supply chain until the lot enters retail sale, and these recordkeeping requirements would be applied to every processor, manufacturer, and handler of these products throughout the supply chain.
“The risk ranking model used by the agency to develop the tentative FTL does not appear to support the need for additional traceability records of all plants that are described as or known as ‘herbs.’ AHPA believes that FDA did not, in fact, intend to assert that the results of the model identified ‘all types of herbs’ as subject to the additional traceability records envisioned by and required by section 204 of FSMA,” Michael McGuffin, AHPA president, said. “Rather, it instead appears that FDA intended to identify only fresh culinary herbs, such as those included in the above-quoted description, for inclusion in the tentative FTL and therefore as subject to the requirements of the rule. AHPA therefore requests that FDA revise the FTL upon issuance of the final rule to specifically identify ‘culinary herbs (fresh).’”
AHPA’s concerns are that a number of low-risk herbs used in dietary supplements, which have exceedingly rare instances of adverse events compared to culinary herbs which are subject to less, if any, processing. For this reason, AHPA requested that the FDA specifically amend the FTL to include culinary herbs.
AHPA’s comments also note that the FTL does not provide specific definitions, and requests that the final rule defines specific commodities, or plant parts, within the rule to provide clear guidance to the industry. AHPA also requested additional consistency in terms of the procedures by which the FDA adds or removes foods from the FTL.
The comments also include an addenda, in which AHPA requested again that the FDA reevaluate the Produce Safety Rule’s expansive definition of “produce” to place it in line with Congressional intent, and requested a number of reformations to the list of produce rarely consumed raw (the RCR list). Commodities on the RCR list are exempt from the proposed recordkeeping requirements. AHPA is among multiple trade associations which have requested that the FDA consider further engaging stakeholders on its proposed rule.
