Information available related to Product Tracing under the FDA Food Safety Modernization Act (FSMA).
- Pilot Projects for Improving Product Tracing along the Food Supply System Final Report
- Draft Methodological Approach to Identifying High-Risk Foods
- Frequently Asked Questions
- Sections of the Law Relating to Product Tracing
- Meetings & Blogs
March 4, 2013 - Final Report Issued; Comments Requested
FDA has released a report on two product tracing pilot projects conducted by the Institute of Food Technologists (IFT) under an existing contract with FDA. FDA announced the pilots on September 7, 2011, indicating that they will enhance the agency's and industry's ability to trace products through the food supply. In conducting these two pilot projects, one for processed foods and one for produce, IFT obtained input from the industry sectors and consulted with USDA, state agencies and consumer groups on proposed foods and/or ingredients and product tracing technologies . The pilots were required under section 204 of the FDA Food Safety Modernization Act, which also requires FDA to establish recordkeeping requirements for high-risk foods to help in tracing products.
The pilot projects were designed to explore and demonstrate methods for rapid and effective tracking and tracing of food, including types of data that are useful for tracing, ways to connect the various points in the supply chain and how quickly data can be made available to FDA. In addition to providing the findings of the pilot projects, the report contains IFT’s recommendations to FDA for improving the tracking and tracing of food. FDA is seeking public comment on this report. We request information that may help us form our own recommendations. We will offer recommendations in our Report to Congress, which also is required by section 204 of FSMA.
After additional data are gathered, FDA will initiate rulemaking on recordkeeping requirements for high-risk foods to facilitate tracing. The FDA must define high-risk foods, considering such factors as the known risks of a food based on foodborne illness data, the likelihood that a particular food has a high potential risk for contamination, and the likely severity of an illness attributed to a particular food. The FDA will hold three public meetings during the comment period on the proposed rule.
FDA is seeking comments on the pilot projects final report. You may submit comments and information, identified by Docket No.FDA-2012-N-1153, by any of the following methods:
- Submit electronic comments (starting March 5, 2013 to July 3, 2013):
- Federal eRulemaking Portal: http://www.regulations.gov.
- Follow the instructions for submitting comments and information.
- Submit written submissions:
- Mail/Hand delivery/Courier (for paper, disk, or CD-ROM submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
- Instructions: All submissions received must include the Agency name and Docket No. FDA-2012-N-1153 for this notice. All comments and information received may be posted without change to http://www.regulations.gov, including any personal information provided.
FDA is required under section 204(d)(2) of FSMA to designate high-risk foods for which additional recordkeeping requirements are appropriate and necessary in order to rapidly and effectively track and trace such foods during a foodborne illness outbreak or other event. This is the first step towards meeting that requirement. View the FDA’s Draft Approach for Designating High-Risk Foods as Required by Section 204 of FSMA.
PT.1.1 What is product tracing and why is it important?
In general, a product tracing system involves documenting the production and distribution chain of products so that in the case of an outbreak or evidence of contaminated food, a product can be traced back to a common source or forward through distribution channels.
Product tracing systems enable government agencies and those who produce and sell food to take action more quickly when an outbreak of foodborne illness occurs or contaminated product is identified, thus preventing illnesses. Actions include removing a product from the marketplace and alerting the public if a product has already been distributed.
Many producers, manufacturers and retailers have product tracing systems in place but they vary depending on the amount of information the system records, how far forward or backwards in the supply chain the system tracks, technologies used to maintain records and the precision with which a system can pinpoint a product’s movement.
PT.1.2 What are the FSMA requirements for product tracing?
Sec. 204, Enhanced Tracking and Tracing of Food and Recordkeeping, has two major requirements. First, FDA, working with the U.S. Department of Agriculture (USDA) and State agencies, must establish pilot projects in coordination with the food industry to explore and evaluate methods and appropriate technologies for rapid and effective tracking and tracing of foods. Second, FDA must publish a notice of proposed rulemaking to establish recordkeeping requirements for high risk foods to help in tracing products.
PT.1.3 Where can I find the statutory language for the requirements?
The statutory language for FSMA sec. 204, Enhanced Tracking and Tracing of Food and Recordkeeping, can be found on the FSMA website at: http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm247548.htm#SEC204.
Product Tracing Pilots
PT.2.1 What did the pilots involve?
Information from the pilots will help to determine what data are most needed to trace a product that has been distributed widely in the marketplace back to a common source. Tracing product forward, such as in the case of an ingredient known to be contaminated, was also tested. Two pilots were required by the FDA Food Safety Modernization Act (FSMA)—one with the processed food sector and one with processors or distributors of raw fruits and vegetables. FSMA required that the pilots reflect the diversity of the food supply, take into account practicality for small businesses and include at least three different types of foods that have been the subject of significant outbreaks during the five-year period preceding the enactment of FSMA in January 2011. FDA also was required to consider international product tracing practices and consult with a diverse and broad range of experts and stakeholders. A report to Congress on the findings of the pilot projects and FDA’s recommendations for improving product tracing is required.
PT.2.2 Does this mean that FDA carried out the pilot studies?
No; these two pilot projects were conducted through an existing contract with the Institute of Food Technologists (IFT). However, IFT carried out the pilots at the direction of FDA, and the Agency retained the ultimate decision making authority.
PT.2.3 Did IFT consult with stakeholders before and during the pilots?
Yes, IFT involved multiple stakeholders throughout the process. IFT obtained input from the processed food and produce industry sectors and consulted with USDA, state agencies and consumer groups on proposed foods and/or ingredients and product tracing technologies. IFT held three stakeholder input sessions in different geographical locations and offered opportunities for written input as well. Food industry representatives, trade associations, consumer groups, third party technology providers, academicians, and others responded to these requests.
PT.2.4 What types of industries were asked to participate in the pilot?
IFT solicited participation in the pilots. FDA indicated it wanted to include industries representing the entire supply chain—from growers to point of sale, such as a restaurant or grocery store. FSMA required that the pilots include at least three different types of foods that have been associated with significant outbreaks in the recent past.
PT.2.5 Will there be additional pilot projects beyond those required under FSMA?
FDA may decide at a later date that additional pilots or studies are needed.
PT.2.6 If I was unable to participate in these pilots, how can I provide input?
There will be additional opportunities for stakeholders to have input on improving product tracing. First, FDA is specifically requesting comments about IFT’s report on the pilot projects, along with other comments and information to help the agency as it implements the FSMA provisions about tracking and tracing and as it develops recommendations for its report to Congress. You can submit comments by (see PT.2.17). Second, FDA must publish a notice of proposed rulemaking to establish recordkeeping requirements for high-risk foods to help in tracing products; there will be a comment period during rulemaking. In addition, FDA must hold at least three public meetings during the comment period in diverse geographical areas of the U.S. to provide persons in different regions of the country with the opportunity to provide input.
PT.2.7 What foods were part of the pilots?
With input from a variety of stakeholders, the following types of foods were selected for the pilot projects:
- Tomatoes, grown in fields and greenhouses; whole and sliced; and distributed to restaurants and other institutions like hospitals, schools and nursing homes, and through grocery stores. We looked at tomatoes because they have been involved in a number of significant and repeat outbreaks. Tomatoes represent a complex food supply chain and were identified by most industry associations as a top candidate for the produce related pilot;
- Frozen Kung Pao-style dishes that contain peanut products, red pepper spice, and chicken were chosen because they contain multiple ingredients involved in significant outbreaks. They also offered a variety of supply chain distribution channels, and, like tomatoes, involved both domestic and imported products.
- Jarred peanut butter and dry, packaged peanut/spice were added to the pilot projects to enhance the complexity of the pilots.
PT.2.8 What is the status of the product tracing pilots required by FSMA?
FDA has just released a report on two product tracing pilot projects conducted by the Institute of Food Technologists under an existing contract with FDA. The report can be found at this link: Pilot Projects for Improving Product Tracing along the Food Supply System – Final Report (PDF: 5.6MB).
FDA announced the pilots on September 7, 2011, indicating that they will enhance the agency's and industry's ability to trace products through the food supply. In conducting these two pilot projects, one for processed foods and one for produce, IFT obtained input from the industry sectors and consulted with USDA, state agencies and consumer groups on proposed foods and/or ingredients and product tracing technologies. The pilot report contains IFT’s recommendations to FDA, and FDA retains the ultimate decision-making authority on how to proceed.
PT.2.9 What does IFT’s report cover?
The IFT report covers baseline studies, pilot execution using trace scenarios, use of technology, cost and benefits, domestic and global practices, findings, recommendations and suggested next steps.
PT.2.10 In the pilots, what were some of the costs to industry to implement a product tracing system?
Available data to assess costs is limited. Within the context of the pilot projects, the report estimated the costs associated with improved recordkeeping and product tracing, and costs varied greatly based on a number of factors such as using a paper-based or electronic system, scanning labels, nomenclature standardization, and electronically linking supply chain partners.
PT.2.11 In the pilots, what were found to be some of the benefits to implementing a product tracing system?
- Product tracing systems enable government agencies and those who produce and sell food to take action more quickly when an outbreak of foodborne illness occurs or contaminated product is identified, thus preventing illnesses.
- As part of the overall project, cost savings, driven by reductions in illness, were estimated for reducing traceback duration by 25, 50, 75, and 100 percent. The range of public health benefit per outbreak ranged from $18,000 to $14 million, depending on the characteristics of the outbreak.
- In addition to quickly discovering which food(s) may be causing an outbreak, we may also be able to determine what foods can be eliminated from consideration, reducing economic impact on the industry.
- Product tracing also is helpful to industry for other functions, such as inventory control.
PT.2.12 In the pilots, what enhancements did technology provide to improve tracing?
The pilot projects found that technology was no substitute for quality data. Once challenges with data quality could be overcome, significant improvements in the speed and accuracy were achieved with the aid of technology. A variety of technology solutions were explored for data capture, visualization, and analysis.
PT.2.13 What were the IFT recommendations?
IFT has 10 recommendations:
- From an overarching perspective, IFT recommends that FDA establish a uniform set of recordkeeping requirements for all FDA-regulated foods and not permit exemptions to recordkeeping requirements based on risk classification.
- FDA should require firms that manufacture, process, pack, transport, distribute, receive, hold, or import food to identify and maintain records of Critical Tracking Events (CTEs) and Key Data Elements (KDEs) as determined by FDA.
- Each member of the food supply chain should be required to develop, document, and exercise a product tracing plan.
- FDA should encourage current industry-led initiatives and issue an Advance Notice of Proposed Rulemaking or use other similar mechanisms to seek stakeholder input.
- FDA should clearly and more consistently articulate and communicate to industry the information it needs to conduct product tracing investigations.
- FDA should develop standardized electronic mechanisms for the reporting and acquiring of CTEs and KDEs during product tracing investigations.
- FDA should accept summarized CTEs and KDEs data that are submitted through standardized reporting mechanisms and initiate investigations based on such data.
- If available, FDA should request more than one level of tracing data.
- FDA should consider adopting a technology platform that would allow efficient aggregation and analysis of data submitted in response to a request from regulatory officials. The technology platform should be accessible to other regulatory entities.
- FDA should coordinate traceback investigations and develop response protocols between state and local health and regulatory agencies, using existing commissioning and credentialing processes. In addition, FDA should formalize the use of industry subject matter experts in product tracing investigations.
For more details on IFT’s recommendations and their report, please go to Pilot Projects for Improving Product Tracing along the Food Supply System – Final Report (PDF: 5.6MB).
PT.2.14 How will FDA use IFT’s report on the pilot projects?
The findings of the pilot projects and corresponding stakeholder input will inform FDA’s report to Congress, which will include FDA recommendations for improving product tracing. In addition, FDA will use the information from these most current pilot projects as well previous pilots studies, public meetings, and information FDA has gathered over the last several years to inform the rulemaking process to establish recordkeeping requirements for high-risk foods to help in tracing products.
Recordkeeping Requirements for High Risk Foods
PT.3.1 What is the FSMA requirement related to recordkeeping for high-risk foods?
Under section 204 of FSMA, FDA is required to designate high-risk foods for which additional recordkeeping requirements are appropriate and necessary and to establish recordkeeping requirements for these foods. The requirement is designed to enable foods to be more rapidly and effectively tracked and traced during a foodborne illness outbreak or other event.
PT.3.2 Did Congress provide any specifics about the recordkeeping requirements FDA is to establish for high-risk foods?
Yes. Congress has established certain specifics about these recordkeeping requirements, including the following:
- they must relate only to information that is reasonably available and appropriate;
- they must be science-based;
- they may not prescribe specific technologies to maintain records;
- the public health benefits must outweigh the cost of complying with the requirements;
- they must be practical for facilities of varying sizes and capabilities;
- to the extent practical, they may not require a facility to change business systems to comply;
- they must allow for the maintenance of records at a reasonably accessible location, provided that the records can be made available to FDA within 24 hours of a request; and
- they may not require a full pedigree, or a record of the complete previous distribution history of the food from the point of origin.
PT.3.3 Did Congress provide specifics about how FDA should determine what foods are high risk under this section of FSMA?
Yes. FDA must consider these factors:
- the known safety risks of a particular food, including the history and severity of foodborne illness outbreaks attributed to such food, taking into consideration foodborne illness data collected by the Centers for Disease Control and Prevention;
- the likelihood that a particular food has a high potential risk for microbiological or chemical contamination or would support the growth of pathogenic microorganisms due to the nature of the food or the processes used to produce such food;
- the point in the manufacturing process of the food where contamination is most likely to occur;
- the likelihood of contamination and steps taken during the manufacturing process to reduce the possibility of contamination;
- the likelihood that consuming a particular food will result in a foodborne illness due to contamination of the food; and
- the likely or known severity, including health and economic impacts, of a foodborne illness attributed to a particular food.
PT.3.4 Has FDA determined which foods are high risk?
No. In February 2014, we published a Federal Register Notice to seek comments and scientific data that will help us refine our draft methodological approach to identifying high-risk foods. After that approach is finalized, FDA will develop the list of high-risk foods.
PT.3.5 Will there be opportunity to comment on the foods FDA determines are high risk?
Yes. FDA plans to publish a list of high risk foods either before, or at the same time, that FDA issues a proposed rule. FDA will provide opportunity to comment on this list.
PT.3.6 When will FDA begin developing recordkeeping requirements for high-risk foods, as directed by FSMA?
Now that the pilot projects that were mandated by section 204(a) of FSMA have been completed, we are continuing to gather data and information as we begin to develop a proposed rule.
PT.3.7 Will FDA expand these additional recordkeeping requirements to apply to foods that are not designated as high risk?
No. FSMA specifies that additional recordkeeping requirements developed under section 204 must apply only to high-risk foods. FDA will be seeking input from stakeholders in considering whether to develop voluntary guidance for foods beyond those designated as high risk to enhance product tracing in the supply chain.
- Stakeholder Teleconference Sponsored by the Food and Drug Administration to Discuss Product Tracing Pilots
September 7, 2011