With thanksgiving right around the corner, food safety is on the minds of many Americans. Currently, tracing the source of a foodborne illness outbreak can be a cumbersome and time-consuming process. However, on November 21, 2022, the Food and Drug Administration (FDA) published a final rule that aims to more efficiently track foods that have a high probability of causing foodborne illnesses. As FDA explains, “the ability to follow the movement of foods through the supply chain—called product tracing or traceability—helps government agencies identify the points in the food supply chain, including the source of the product, where contamination may have occurred and, working with industry, remove the food from the marketplace.” 87 Fed. Reg. 70910, 709312.
The final rule, entitled “Requirements for Additional Traceability Records for Certain Foods”, establishes regulations that require food manufacturers, processors, packers, and holders to keep certain records and include certain codes on foods. In the Final Rule, FDA states that the regulations will help FDA “rapidly and effectively identify recipients of foods to prevent or mitigate foodborne illness outbreaks and address credible threats of serious adverse health consequences or death resulting from foods being adulterated or misbranded.” This article first explains the history of food traceability regulations, and then gives a brief overview of what the newly published rule requires.
Congress first directed FDA to promulgate food traceability regulations through the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. As directed, FDA published regulations in December 2004. These food traceability regulations—found in 21 C.F.R. Part 1, Subpart J—only “enable FDA to identify the immediate previous sources and immediate subsequent recipients of foods to address credible threats of serious adverse health consequences or death to humans or animals.” 85 Fed. Reg. 59984, 59985. However, following the adoption of these regulations “FDA has learned that the one-up, one-back recordkeeping requirements in those regulations do not capture all the data elements necessary to effectively and rapidly link shipments of food through each point in the supply chain.” 87 Fed. Reg. 70912.
On January 4, 2011, President Obama signed the Food Safety Modernization Act (FSMA) into law. Section 204(d)(1) of FSMA directs FDA to “publish a notice of proposed rulemaking to establish recordkeeping requirements, in addition to the requirements [mentioned above], for facilities that manufacture, process, pack, or hold foods that the Secretary designates under paragraph (2) as high-risk foods.” Paragraph (2) of section 204(d) states that FDA “shall designate high-risk foods for which the additional recordkeeping requirements described in paragraph (1) are appropriate and necessary to protect the public health.”
As directed by Congress through FSMA, FDA published a food traceability proposed rule on March 23, 2020. FDA explained in the 2020 proposed rule that Subpart J applies to all foods, whereas the new regulations—which will be codified in 21 C.F.R. Part 1, Subpart S—will apply only to those foods FDA includes on the Food Traceability List (FTL). FDA accepted comments on the proposed rule until January 21, 2021, and received about 1,190 comments. After going through the comments, FDA published the final rule on Monday, November 21, 2022.
Food Traceability requirements
The final rule explains that its requirements are “focused on having persons who manufacture, process, pack, or hold FTL foods maintain and provide to their supply chain partners specific information (key data elements) for certain critical tracking events (CTEs) in the handling of the food”. 87 Fed. Reg. 70910.
The Food Traceability Plan
The final rule requires those who manufacture, process, pack, or hold FTL foods to establish and maintain a traceability plan. Food traceability plans must include:
- A description of the procedures the entity uses to maintain required records, including the location and format of the records;
- A description of the procedures the entity uses to identify foods on the FTL;
- A description of how the entity assigns traceability lot codes (if applicable);
- A statement identifying who FDA should contact regarding the food traceability plan; and
- A farm map (if applicable).
The rule requires only certain entities to include in their food traceability plans a description of how the entity assigns food traceability lot codes. The entities responsible for assigning food traceability lot codes include:
- Initial packers of raw agricultural commodities (who are usually the second or third in the supply chain after the harvesters and coolers who are required to provide initial packers information about their activities);
- Initial land-based receivers of FTL foods obtained from a fishing vessel; and
- Those that transform an FTL food (by manufacturing/processing or by changing the food or the packaging/labeling).
Another element of the food traceability plan that only applies to certain entities is the farm map. The rule requires those who grow FTL foods to create and maintain a farm map as part of the food traceability plan. The farm map must show, with coordinates, where the FTL food is grown or raised.
The final rule has specific record keeping requirements depending on which type of business the regulated entity is involved in. For example, the new 21 C.F.R. §1.1325 lists the record keeping requirements for harvesters and coolers of raw agricultural commodities on the FTL, whereas the next section includes the record keeping requirements for initial packers of raw agricultural commodities on the FTL.
Exemptions and Waivers
The final rule provides many exemptions and a process for applying for waivers. If an entity is exempted, that means the rule simply does not apply to them. Meanwhile, an entity may apply for a waiver and request FDA to exempt them from complying to the rule in whole or in part.
The rule expressly exempts:
- Certain small producers;
- Certain shell egg producers;
- Farms that sell or donate directly to consumers;
- Food produced and packaged on a farm whose packaging maintains product integrity and prevents subsequent contamination;
- Foods the receive certain types of processing such as foods changed in a way so that they no longer are a food on the FTL;
- Produce rarely consumed raw;
- Certain raw bivalve molluscan shellfish;
- Persons who manufacture, process, pack, or hold FTL foods regulated by the United States Department of Agriculture;
- Commingled raw agricultural commodities (not including fruits and vegetables subject to the produce safety rule);
- Small retail food establishments and small restaurants;
- Retail food establishments and restaurants purchasing directly from a farm;
- Farm to school and farm to institution programs;
- Fishing vessels;
- Nonprofit food establishments;
- Those manufacturing, processing, packing, or holding food for personal consumption;
- Those holding food on behalf of individual consumers; and
- Food for research or evaluation.
The rule additionally has a section that outlines under what circumstances and the procedures entities should follow to receive a waiver. The final rule explains that “persons may request modified requirements or an exemption from the new traceability recordkeeping requirements for a specific food or type of entity on the grounds that application of the requirements to that food or type of entity is not necessary to protect the public health.” 87 Fed. Reg. 70911. An entity can also request a waiver “on the grounds that having to meet the requirements would result in an economic hardship to the unique circumstances of that entity or type of entity.” 87 Fed. Reg. 70911.
What’s to Come
Although the effective date of the final rule is 60 days after it was published on the Federal Register, its compliance date is 3 years later. According to FDA, “the compliance date for all persons subject to the recordkeeping requirements is Tuesday, January 20, 2016.” The three-year compliance period allows those regulated by this rule time to implement the recordkeeping requirements.
To read FDA’s news release announcing the rule, click here.
FDA’s FTL can be found here.
To learn more about food safety generally, read NALC’s food safety reading room, here.
**This article was written by former NALC Staff Attorney Jana Caracciolo.