iFoodDS Submits Comments on FDA’s Traceability Rule 204

The Federal Food and Drug Administration’s (FDA) comment period for its proposed Rule 204 for Food Traceability closed on February 23.  Over 300 comments were received from companies and organizations since FDA announced the proposed rule in September.  iFoodDS was among those who submitted comments with ideas to improve or clarify provisions within the proposed rule, however, the company stated its overall support for the new rule and its enhanced consumer protections.

iFoodDS supporting comments included:  “Our company is a strong proponent of supply chain transparency in the food industry. We are committed to the use of electronic records, real-time data, whether traceability or food safety data, as needed to ensure the protection of consumer health and the prevention of foodborne illnesses. We also are advocates for the companies that grow, harvest, manufacture, transport and sell our food. This is an essential industry where dedicated individuals and their families spend their resources and lives committed to putting food on our tables. For these reasons, we are supporters of the FDA’s work on FSMA’s Section 204 and this proposed rule enabling rapid traceback and traceforward benefits in addition to enhanced root cause analysis capabilities.”

Among the iFoodDS suggested improvements is for FDA to incentivize companies who are in early compliance with the rule.  “All companies will have two years to implement the requirements once the rule is finalized. During these two years, consumers and the industry will continue to face the same foodborne illness investigation issues and resulting adverse impact on public health. Our recommendation to the FDA is instead of waiting for two or more years for implementation, why not encourage companies to adopt the rule earlier and as recognition for early implementation include those companies in a collaborative recall investigation process? A robust collaborative recall process would provide an opportunity to identify sources and subsequent root cause analysis during and after an investigation without triggering legal recriminations, absent any malfeasance.”

iFoodDS stated that the impact of COVID-19 should also require direct-to-consumer companies comply with the rule. iFoodDS comments:  “As we have seen with COVID-19, consumers are shifting from in-store and restaurant purchases to direct-to-home or curbside delivery. Given this new reality, the proposed rule does not address this growing segment of the supply chain, rendering the rule dated before its implementation. The recommendation is the FDA include companies selling directly to consumers (even small retailers, home delivery, etc.) that are adopting this rule and introducing consumer level traceability for their products.”

The comments also point out that FDA’s proposed rule may not adequately protect vulnerable populations. “We need to provide safe food to all consumers regardless of which company provides food to them and how it is delivered…Programs operating under USDA, state agencies, or local jurisdictions are exempt from the proposed rule including schools, food banks, and institutional programs such as WIC and food for low-income seniors. Therefore, two of the most vulnerable population groups – children and the elderly – are excluded from the food safety benefits this rule is presumed to provide.”

iFoodDS provided FDA input for improvement in the areas of imported produce; the Food Traceability List, specifically if a product can be removed from the list when a kill step is identified; co-mingled products; ingredients; as well as a recommendation that FDA demonstrate the financial benefits to companies impacted by the rule including long-term savings from electronic reporting and streamlining existing internal processes.

iFoodDS concluded its comments with the following:  “This proposed rule is another FSMA milestone on the way to a safer food supply. We encourage the FDA to regard this rule and all other FSMA rules as part of an evolving process taking into account our ever-increasing knowledge of food safety and measures for reducing illness and outbreak risks.”

FDA’s Rule 204 outlined new traceability recordkeeping requirements for many fruit and vegetable commodities.  According to the FDA: “This proposed rule would create a first-of-its-kind standardized approach to traceability recordkeeping, paving the way for industry to adopt and leverage more digital, tech-enabled traceability systems both in the near term and the future.”

Among the rulemaking provisions, the FDA’s proposal would continue to allow paper traceability records, however, companies will need to submit an electronic sortable spreadsheet within 24 hours of a request from the agency.   But FDA added:  “More generally, the FDA encourages all food businesses to maintain their traceability records electronically whenever possible, to expedite the identification of traceability information when needed to address threats to public health.”

Moving companies from paper-based recordkeeping systems to digitized data in an easy and cost effective manner is the goal of iFoodDS products and services.  “We understand that implementation of new traceability systems can seem like a big undertaking, but it doesn’t need to be,” explains Diane Wetherington, iFoodDS Executive Chair of the Board. “Our team guides companies through all phases of implementation and use of cloud-based, software solutions, including iFoodDS HarvestMark products, which provide item-level traceability throughout the supply chain.”

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This material is for informational purposes only and not for the purpose of providing legal advice. You should contact your attorney to obtain advice with respect to any particular issue or problem.