Food

Resources for You

Product Tracing

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
Frequently Asked Questions
Sections of the Law Relating to Product Tracing
Meetings
Updates

Pilot Projects for Improving Product Tracing along the Food Supply System

In a nutshell: The U.S. Food and Drug Administration announced Sept. 7, 2011, that the Institute of Food Technologists (IFT) will carry out two new pilot projects at the direction of FDA 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. The pilots are 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. IFT will solicit stakeholder input in designing and implementing the pilots.

In the design and implementation of the pilot projects, IFT will:

Conduct one pilot in coordination with the processed food sector to explore and demonstrate the tracking and tracing of a processed food and a few key ingredients.
Conduct one pilot in coordination with the produce sector to explore and demonstrate tracking and tracing of selected fruits and/or vegetables.
Conduct mock tracebacks with a goal of identifying a common source in the supply chain.
Consult with the U.S. Department of Agriculture, state public health agencies and nongovernmental organizations that represent consumer interests.
Ensure that the pilots:
- reflect the diversity of the food supply,
- are practical for facilities of varying sizes, including small businesses,
- include different types of FDA-regulated foods that have been the subject of significant outbreaks between 2006 and 2010.
- address the supply chain from farms to restaurants and grocery stores; and
Assess the costs and benefits of the methods for rapid and effective tracking and tracing of the selected foods and key ingredients.

After the pilots are completed and additional data are gathered, the 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.

The Institute of Food Technologists (IFT), a nonprofit scientific society consisting of professionals engaged in food science, food technology and related professions, will carry out the pilots as a new task order for $498,149 under an existing FDA contract.

Frequently Asked Questions on Product Tracing

General

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/FoodSafety/FSMA/ucm247548.htm#SEC204.

PT.1.4 Your priorities for FSMA did not list when you will run pilots on overarching food traceability systems. When will this be a priority?
On September 7, FDA announced two product tracing pilot projects that will enhance the agency's and industry's ability to trace products through the food supply. These two pilot projects, one for processed foods and one for produce, are being conducted through an existing contract with the Institute of Food Technologists (IFT). IFT will carry out the pilots at the direction of FDA, and the Agency will retain the ultimate decision making authority. IFT will obtain input from the industry sectors and consult with USDA, state agencies and consumer groups on proposed foods and/or ingredients and product tracing technologies. If North Carolina is interested in participating, please contact IFT (see Frequently Asked Questions section for Product Tracing on FSMA website for contact info). Prioritization is an important part of our implementation strategy. It is clear that we cannot meet all of the deadlines in the statute. We are focusing first on those with the greatest public health benefit, such as preventive controls, inspection and compliance, and the import provisions. Product tracing is a component of the Inspection and Compliance Team.

As new information becomes available on the pilots and prioritization, as well as other aspects of FSMA, FDA will update its website at http://www.fda.gov/fsma. See below for more information on the Product Tracing Pilots.

Product Tracing Pilots

PT.2.1 What will the pilots involve?
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, also will be tested. Two pilots are required—one with the processed food sector and one with processors or distributors of raw fruits and vegetables. The pilots must 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 must 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 recommendations for improving product tracing is required.

PT.2.2 Will other data be collected to add to what is learned from the pilots?
Yes. FSMA requires FDA to collect additional data to assess the costs and benefits associated with the adoption and use of several product tracing technologies; the feasibility of such technologies for different sectors of the food industry, including small businesses; and whether such technologies are compatible with the product tracing requirements in FSMA. FDA must also ensure that effective procedures exist to prevent the unauthorized disclosure of any confidential information.

PT.2.3 Does this mean that FDA will carry out the pilot studies?
No; these two pilot projects are being conducted through an existing contract with the Institute of Food Technologists (IFT). However, IFT will carry out the pilots at the direction of FDA, and the Agency will retain the ultimate decision making authority.

PT.2.4 Why is IFT conducting the pilot studies?
The pilot studies are being conducted as a new task order under an existing contract with IFT, which is a nonprofit scientific society that has expertise in product tracing. In 2009, FDA, under an existing contract with IFT, conducted a mock traceback scenario for tomatoes with representatives of the industry, academia, state governments and two technology companies. FDA also awarded a one-year task order under the existing contract to IFT to review industry practices for product tracing and identify best practices employed by many different sectors regulated by FDA; the IFT report, 2009 IFT Report Findings and Recommendations to FDA: Traceability (Product Tracing) in Food Systems, can be found at http://www.ift.org/traceability.

PT.2.5 Will IFT consult with stakeholders before and during the pilots?
Yes, IFT will involve multiple stakeholders throughout the process. IFT will obtain input from the processed food and produce industry sectors and consult with USDA, state agencies and consumer groups on proposed foods and/or ingredients and product tracing technologies.

PT.2.6 What types of industries will be asked to participate in the pilot?
IFT will be soliciting participation in the pilots. FDA has indicated it wants to include industries representing the entire supply chain—from growers to point of sale, such as a restaurant or grocery store. The FSMA requires that the pilots include at least three different types of foods that have been associated with significant outbreaks in the recent past. FDA will select the specific product types to be evaluated in the pilots.

PT2.7 How can I become involved in one of the pilot projects for product tracking?
Interested stakeholders should contact Caitlin Hickey at IFT to volunteer for the pilots. Her contact information is chickey@ift.org, 202-330-4985.

PT.2.8 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.2.9 If I'm unable to participate in these pilots, how can I provide input?
As part of the process, IFT will be soliciting input on FDA’s behalf. While IFT will allocate a few hours per month for discussions and demonstrations, IFT encourages technology providers and other interested parties to contact Caitlin Hickey (chickey@ift.org, 202-330-4985) to be placed on a contact list. IFT will provide several formal opportunities for companies and individuals to offer input.

PT.2.10 What foods will be 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 are looking 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 offer a variety of supply chain distribution channels, and, like tomatoes, can involve 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.

Recordkeeping Requirements for High Risk Foods

PT.3.1 Did Congress provide any specifics about the recordkeeping requirements FDA is to establish for high-risk foods?
Yes. Congress has established certain 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.3.2 Did Congress provide specifics about how FDA should determine what foods are high risk?
Yes. FDA must consider such factors as the known safety risks of a food based on foodborne illness data and the likelihood that a particular food has a high potential risk for contamination.

PT.3.3 Will there be opportunity to comment on the foods FDA determines are high risk?
Yes. The proposed rule that FDA develops will have a comment period, and FSMA requires that at least three public meetings be held during that comment period in diverse geographical areas of the U.S. to provide persons in different regions the opportunity to provide input.

PT.3.4 When will FDA begin developing recordkeeping requirements for high-risk foods, as directed by FSMA?
Once the product tracing pilots are completed, and other data are gathered, the Agency will begin the development of a proposed rule.

PT.3.5 Will FDA expand requirements for recordkeeping requirements 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.

PT.3.6 Will FDA recommend certain product tracing technologies either for the pilot or for future regulations and potential guidance?
FDA does not plan to recommend specific software or systems at any of these stages. Rather, FDA will focus on the elements of a product tracing system that enable rapid and effective tracing of food products. Under section 204, FDA is not permitted to prescribe specific technologies to maintain records in the context of the additional recordkeeping requirements for high-risk foods.

PT.3.7 Will FDA use information other than that provided by the pilot projects and the additional data gathering FSMA requires to develop recordkeeping requirements for high risk foods and any potential guidance?
Yes, FDA has studied product tracing for more than a decade. In 2008, FDA held two public meetings on product tracing for fresh produce. In 2009, FDA, in conjunction with USDA’s Food Safety and Inspection Service, held a public meeting on how to enhance product tracing systems for all foods. FDA also has worked with IFT on various product tracing scenarios. FDA has been gathering information by listening to stakeholders’ input, learning about various technologies, and staying abreast of industry and other government product tracing initiatives. The information that has been accumulated will be used by FDA in fulfilling the requirements of section 204.