In both legislative and regulatory circles, the issue of food traceability has drawn considerable attention in recent years. While several congressional bills have included traceability either as a component or as the exclusive focus, the
Food Safety Modernization Act of 2010 (FSMA) contains several components that address food traceability.
PMA through the Produce Traceability Initiative (PTI) commented to FDA on traceability pilots in 2013. The FDA has also published a docket on the designation of High-Risk Foods for Tracability and provided their methodological approach to identifying high risk foods in February 2014.
For the purpose of this page, FSMA is the sole focus, as it is the only bill that has been signed into law to date that addresses traceability. Responsibility for developing regulations to implement the law falls to the Food and Drug Administration.
FSMA and Traceability
FSMA (hereafter referred to as “the act”) contains several references to traceability, including calling for:
- recommendations for enhanced food traceability, including pilot programs for fresh produce;
- analyses of the economic and global trade impacts of track-and-trace systems on the food supply; and
- enhancing FDA’s infrastructure and reporting systems to incorporate traceability.
In short, the act requires that FDA establish a system that improves the capacity to effectively track and trace food, based on lessons learned after conducting several studies and pilot projects. In addition, FDA is directed to issue regulations requiring enhanced recordkeeping for what it determines and makes public to be “high risk foods”. This recordkeeping system must be science-based and technologically neutral, and have benefits that outweigh the burdens of the additional requirements. It is not required to track the full pedigree of information, or to require product tracing to the case level. Grocery stores buying directly from farms are exempted from recordkeeping requirements for those products, other than retaining for 180 days records documenting the source of the food.
What the Act means for the produce industry
The act contains a number of provisions directly relevant to the fresh produce industry:
- Performance review: The Secretary of Health and Human Services is directed to report on FDA’s performance in foodborne illness outbreaks involving fruits and vegetables during the five-year period preceding the date of enactment of the Act (i.e., 2005-2009). This report will include recommendations for enhanced surveillance, outbreak response, and traceability.
- Pilot projects: The Secretary is also directed to commission conduct of one or more pilot projects in coordination with processors or distributors of fruits and vegetables that are raw agricultural commodities, and one or more such pilot projects in coordination withthe processed food sector.. These pilots must include at least three different types of foods that have been the subject of significant outbreaks during the five-year period preceding enactment of the act. The foods and pilots are to be selected in order to:
- develop and demonstrate methods for rapid and effective tracking and tracing of foods in a manner that is practicable for facilities of varying sizes, including small businesses;
- develop and demonstrate appropriate technologies, including technologies existing on the date of enactment of the act, that enhance the tracking and tracing of food; and
- inform FDA’s decisions on the exact requirements of traceability, to help it promulgate implementing regulations.
The Secretary is directed to report to Congress on the pilot project’s findings along with recommendations for improving the tracking and tracing of food no more than 18 months after the date of the act’s enactment.
- Economic impact analysis: FDA is also tasked with studying the economic and global impacts that a food traceability system would have on the supply chain. The act states FDA and USDA leaders will:
- examine the costs and benefits associated with adoption and use of several product tracing technologies, including technologies used in the pilot projects;
- assess how these technologies will be used in different sectors of the food industry;
- assess how these technologies align with domestic and international product tracing practices and systems already in commercial use; and
- consult with a diverse and broad range of experts and stakeholders, including representatives of the food industry, agricultural producers and nongovernmental organizations that represent the interests of consumers.
- Track and track system establishment: The act also directs the Secretary of Health and Humans Services, in consultation with the Secretary of Agriculture, to establish within FDA a product tracing system to receive information that improves the capacity of the agency to effectively and rapidly track and trace food that is in the United States or offered for import into the United States. Prior to doing this, the Secretary is directed to examine the results of applicable pilot projects to ensure that the activities of such system are adequately supported by the pilot programs’ results.
Previous regulatory activities in the traceability arena
FSMA isn’t the federal government’s first foray into traceability. The agency initially explored the issue in its 1998 Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables. In those non-binding recommendations, FDA acknowledged that the ability to identify the source of a product through traceback can serve as an important complement to good agricultural and management practices intended to prevent the occurrence of food safety problems.
At that time, FDA suggested that, at a minimum, an effective traceback system should document the source of a product, and have a mechanism for marking or identifying the product that can follow the product from the farm to the consumer. Specifically, FDA sought information on date of harvest, farm identification and who handled the produce from grower to receiver.
Since then, as a result of national food safety outbreaks linked to fresh produce in the intervening years, FDA has taken a stronger interest in food traceability systems. In addition to being part of the Bioterrorism Act of 2002 which mandated so-called “one-up, one-back” recordkeeping, traceability was included in FDA’s Food Protection Plan. Specifically related to produce, the agency held public meetings to stimulate and focus a discussion about mechanisms to enhance product tracing systems for fresh produce in October and November 2008. In late 2009, FDA and the U.S. Department of Agriculture’s Food Safety and Inspection Service held a joint public meeting on food product tracing.
At these meetings, PMA representatives spoke about traceability challenges facing the industry, and presented the Produce Traceability Initiative developed by industry to address those challenges. On other occasions, PMA has also provided FDA with
comments concerning traceability and has included traceability components in comments on FDA’s docket on
preventive controls for fresh produce, as well as in comments concerning draft food safety guidance for
melons,
tomatoes, and
leafy greens.
What FSMA means for the Produce Traceability Initiative
In response to requests by their members, PMA, Canadian Produce Marketing Association (CPMA) and United Fresh Produce Association (UFPA) announced the formation of a joint Produce Traceability Initiative (PTI) in October 2007 to drive broad adoption of consistent traceability best practices throughout the produce supply chain. In February 2010, GS1 US also joined the initiative.
The PTI’s vision is to achieve chain-wide, electronic traceability at the case level by 2012. Seven intermediate milestones have been established to guide implementation. The initiative is guided by a Leadership Council whose membership hails from across the supply chain. Four volunteer-staffed working groups guide related work in areas including data standardization and synchronization, implementation tools and resources, assessing technology needs and identifying standardized solutions, and industry communications. For more information about those milestones and for best practices and other resources, visit
www.producetraceability.org. Industry associations and GS1 member organizations worldwide also have input.
At the time of this writing, it remains to be seen what if any impact implementation of FSMA will have on the PTI. As noted above, considerable work remains to be done before FDA will be in a position to decide upon what it deems to be an appropriate federal track and trace solution. The PTI offers a globally-established, market-proven solution that is being studied by many segments of the fresh food industry – and the buyers who retail their goods – as the model to follow. Meanwhile, many companies are proceeding with implementation of the PTI vision because they realize that the human and economic costs – and the related legal liability – of another significant foodborne illness outbreak are more than they want to bear.
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