Toward the end of last year, the Food and Drug Administration (FDA) proposed additional traceability recordkeeping requirements, beyond what is already required in existing regulations, for those involved in the production of foods included on the Food Traceability List. The new rule was proposed in order to enhance and modernize recordkeeping across the products which fall under its jurisdiction, in order to expedite the tracking of foodborne illnesses.
 
For materials which are on the Food Traceability List, which could include ingredients under the functional foods and beverages category, the FDA would require enhanced traceability and recordkeeping measures that go beyond the baseline – the agency hopes to abandon paper-based records and establish a “universal lexicon” of all products that fall under the jurisdiction of the Food Traceability List. The rule calls for all companies that manufacture foods to establish and maintain records associated with specific critical tracking events: growing, receiving, transforming, creating, and shipping. For each of these events, entities would be required to establish and maintain records containing a lot code, product received date, the shipping date, and a product description.

Industry Responses
 
The Council for Responsible Nutrition, a trade association represent the dietary supplements industry, noted that while the list doesn’t mention dietary supplements, it does mention ingredients featured in some types of dietary supplements and other ingredients which aren’t regulated as food. CRN said that because “Dietary supplements” were one of the commodities used in a risk-ranking model to develop the list, and because foodborne illness outbreaks in dietary supplements are exceptionally rare compared to foods, FDA should specifically confirm that dietary supplement manufacturers are not required to adhere to this proposed rule.  
 
In a statement submitted to FDA during the ongoing public comment period for the new rule, CRN requested that FDA adopt a modification to exempt non-produce, as well as produce that undergoes processing to reduce the presence of microorganisms to public health significance. The organization believes that this modification would uphold FDA’s goal of mitigating foodborne illness outbreaks while preventing unnecessary confusion and cost burdens for the supplements industry.
 
“CRN understands, based on the preamble to the proposed rule and FDA’s subsequently-released Frequently Asked Questions document, that FDA’s proposed traceability recordkeeping requirements for “high risk” foods on FDA’s Food Traceability List (FTL) will not apply to dietary supplements and dietary ingredients,” Haiuyen Nguyen, senior director of Scientific and Regulatory Affairs for CRN, said. “The FAQs clarified that the risk-ranking model FDA used to develop the FTL assessed the risks of dried spices and dried vegetables in the commodity categories ‘Spices’ and ‘Vegetables (Dried)’ which were not included in the proposed FTL. Therefore, dried spices and dried vegetables will not be covered by this proposed rule. Similarly, CRN assumes all dietary supplements and dietary ingredients, including dried herbs, dried vegetables, and fish or krill oil, were included in the commodity category ‘Dietary supplements,’ which is not on the FTL, and therefore will be exempt from the proposed rule[…] To avoid confusion and prevent unnecessary costs, CRN requests that FDA adopt this recommended modification and confirm in its final rulemaking that dietary supplements and dietary ingredients will not be subject to this rule.”
 
Of the 103 foodborne illness outbreaks FDA lists on its website since 2011, only one was related to a dietary supplement or dietary ingredient. Additionally, dietary supplement manufacturing requirements entail processing which eliminates microorganisms from ingredients, which is not limited to produce.
 
For this reason, CRN suggested that FDA include foods other than produce which are subject to processing which reduces their public health risk.
 
“We thus urge FDA to modify section 1.1305(d)(1) to exempt not only produce, but also any other food on the FTL subject to processing that adequately reduces the presence of microorganisms of public health significance,” Nguyen said. “This modification would remove unnecessarily burdensome recordkeeping requirements for persons handling food that receives such processing, while still upholding the proposed rule’s public health objectives.”
 
In comments submitted by IFT (Institute of Food Technologists) a wide array of key recommendations regarding key elements that the organization believes reflect best practices, where were not present in the most recent adaptation of the proposed rule.
 
Summarily, IFT believes, according to its public comment, there should be more global uniqueness and greater clarity regarding traceability codes, include entities further upstream in a supply chain (namely restaurants, retailers, and small businesses) to prevent issues with traceability. The organization also recommends incorporating additional critical tracking events (events which must be recorded to allow for effective traceability along the supply chain), and key data elements for certain food types and manufacturing entities.
 
“IFT welcomes the advance in food traceability adoption and standardization supported by this proposed rule,” Noel Anderson, president, and Christie Tarantino-Dean, FASAE, CAE, IFT CEO, said. “We support the methodology used to construct the food traceability list, finding it to be evidence-based and rigorous, yet not over-reaching[…] There are a few areas where we perceive additional modifications will be necessary to achieve successful implementation: 1) development and review of listed item-specific templates, 2) further clarification on what constitutes unique identification and available options, 3) revision of the first receiver concept and approach to one that is an easily recognizable, familiar and consistent point in the supply chain, and 5) our evolving realities of data and record keeping and what an appropriate conceptualization of record 22 establishment and maintenance means in the digital age. Finally, throughout the rule, we urge the FDA to avoid overly prescriptive approaches to record keeping and instead focus on clarifying the outcome that impacted parties must achieve (provision of information necessary to traceback to source in <24 hours).”