The Food Safety Modernization Act (FSMA), signed by President Obama January 4, 2011, is the most sweeping reform of Food and Drug Administration (FDA) authority in more than 70 years. The law, which is complex as well as broad in scope, requires implementation over a period of time. Some portions of the FSMA, especially produce safety and traceability, will impact growers.
Harvesting leaf lettuce with modern farm equipment in Yuma, Ariz.
PHOTO BY JEFF VANUGA, NRCS.
The proposed produce safety regulation will set enforceable standards for fresh produce safety at the farm and packinghouse. At this writing, it has not yet been issued.
The FSMA directs the FDA to explore rapid and effective methods to track and trace food throughout the entire supply chain. This includes ways to connect the various points and hasten data accessibility to the FDA.
Section 204 of the FSMA, enhanced tracking and tracing of food and recordkeeping, has two major requirements. First, it requires FDA to establish pilot projects to explore and evaluate methods and technology for rapid and effective tracking and tracing of foods.
Second, the FDA must establish a product tracing system and additional recordkeeping requirements for high-risk foods. The FDA, as of this writing, has not yet identified high-risk foods.
The FDA has contracted the Institute of Food Technologists (IFT) to carry out the two pilot projects: one for produce, the other for a processed food. After the pilots are completed, the FDA will initiate rule-making. As with other rule-making, the FDA first issues proposed rules, which are published in the Federal Register and on the FDA's official docket on www.regulations.gov. Then a comment period and in this instance at least three public meetings in various geographic areas follow. After considering the comments, the FDA issues a final rule. The regulation will be published as above.
The pilot studies are scheduled to be submitted to the FDA by June 2012. The time line on the rules points to 2013.
The FDA's Deputy Commissioner for Foods, Michael R. Taylor, ponders a question from a grower on food safety standards for leafy greens
PHOTOS BY BOB FERGUSON, UNLESS OTHERWISE NOTED.
The processed food item pilot must be a frozen or ready-to-eat cooked item. A preparation that contains chicken, peanuts and spices was chosen. For the produce pilot, tomatoes were selected. These were ultimately the FDA's decision.
Tejas Bhatt, the IFT's lead scientist for the pilot project, explains the tomato choice: "It's a diverse product which represents the challenges. It's comingled, processed and minimally processed. It's used in food service as well as grocery stores, it's distributed widely and has a short shelf life." Tomatoes are an important crop and produced by all sizes of farm operations. Plus, tomatoes are imported.
The IFT has conducted earlier tracing studies for the FDA. In 2009, an IFT project included a mock trace-back scenario for tomatoes. Those recommendations can be accessed at www.ift.org/traceability.
Bhatt says the tomato industry continues to offer overwhelming feedback and support. "They know the importance of tomatoes and recognize the role they play in keeping the product safe," he says.
In its earlier reports the IFT indicated the desirability of electronic tracing systems. However, Bhatt indicated, "Some small growers may not be able to sustain that." Recordkeeping standards, he said, can be nontechnical. He notes that to be traceable, all in the supply chain must have a common language in order to communicate with each other.
The FDA has indicated that it doesn't plan to recommend specific software or systems. Rather, it will focus on the elements of the system. Under the act, the FDA may not prescribe specific technologies. Further, the recordkeeping requirements must be science-based, and must relate only to information that is reasonably available and appropriate. They must allow for records maintenance at a reasonably accessible location, provided that the records can be made available to the FDA within 24 hours of a request.
Reggie Brown, executive director of the Florida Tomato Exchange, shares the experiences of the entire fresh tomato industry in developing their comprehensive Tomato Metrics.
Bhatt emphasized that a significant component of the pilot studies is cost/benefit analysis. Further, the guidelines or rules will likely be phased in. Whether the FDA will require any or all of the rules to be binding, or mandatory, apparently has not yet been decided.
For contributions to the pilots, the IFT has established five panels. So far, over 75 members, which include industry, government and academia, have volunteered. The panels comprise oversight, traceback investigation, produce, processed food and cost.
The pilot projects' goals include evaluating the different traceability solutions currently in the market, and identifying the potential opportunities and challenges to enable interoperability between the different traceability solutions.
Reggie Brown, executive director of the Florida Tomato Exchange, agrees with Bhatt that the tomato industry understands the needs and challenges that exist in that fairly complex industry. Commenting on the efforts of the industry, Brown said, "The tomato industry has done its homework. It has good infrastructure. There's a lot of cooperation across the entire supply and distribution system."
Brown pointed to the thorough coverage of the Tomato Metrics, developed in 2008 to create a single audit checklist for fresh tomato production and handling anywhere in the U.S. or Mexico. Continually reviewed, the 2011 four audit revisions cover open field production, harvest and field packing; greenhouse; packinghouse; and repacking and distribution. The standards appear at www.floridatomatoes.org/Food-Safety.aspx or at the United Fresh Produce Association's website: www.unitedfresh.org/tomatometrics. The standards include documentation, traceability records and procedures.
Many companies in the produce industry are already actively involved in establishing or maintaining tracing systems for their operations.
Produce traceability initiative
A co-chair of the Produce Safety Alliance's post-harvest committee and Rutgers agricultural agent for Cumberland County in South Jersey, Wesley Kline has educated growers on good agricultural practices for over 10 years.
The Produce Marketing Association, Canadian Marketing Association and the United Fresh Produce Association formed a joint produce traceability initiative (PTI) in October 2007. Their action plan's goals include ensuring a process workable through the entire supply chain. One PTI vision is electronic traceability at the case level in 2012. A systematic approach with standard protocols could enhance overall traceability speed and efficiency. For example, the GS1 Global Trade Item Number (GTIN) is analogous to UPCs in use for items. The PTI explains that what the UPC does for item level identification, the GTIN does for case level identification. Since both numbering protocols are managed by GS1, the systematic usage of GTIN allows direct standardized interaction between differing internal coding systems unique to each company. The PTI website (www.producetraceability.org
) can provide more specifics.
As noted, the proposed rules on produce safety have not yet been issued as of this writing. However, the FDA has indicated in the abstract of the rule in its regulatory agenda issued on January 20, 2012, that the rule may not be entirely mandatory and that the rule will be scale-appropriate.
The abstract states, in part, "The proposed rule will be based on prevention-oriented public health principles and incorporate what we have learned in the past decade since the agency issued general good agricultural practice guidelines entitled, 'Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables' (GAPs Guide). The proposed rule also will reflect comments received on the agency's 1998 update of its GAPs Guide and its July 2009 draft commodity specific guidance for tomatoes, leafy greens and melons. Although the proposed rule will be based on recommendations that are included in the GAPs guide, [the] FDA does not intend to make the entire guidance mandatory."
The abstract continues, "[The] FDA's proposed rule would, however, set out clear standards for implementation of modern preventive controls. The proposed rule also would emphasize the importance of environmental assessments to identify hazards and possible pathways of contamination and provide examples of risk reduction practices, recognizing that operators must tailor the preventive controls to particular hazards and conditions affecting their operations. The requirements of the proposed rule would be scale appropriate and commensurate with the relative risks and complexity of individual operations. [The] FDA intends to issue guidance to assist industry in complying with the requirements of the new regulation."
Also, while the FDA did not monetize estimates of the costs and benefits of the proposed regulation, it projects that costs to more than 300,000 domestic and foreign producers and packers of fresh produce would include one-time costs such as new tools and equipment, and recurring costs including monitoring, training and recordkeeping. The benefits would be a reduction in foodborne illnesses and deaths.
In general, the Tester amendment to the FSMA exempts farms that sell less than $500,000 annually, and sell exclusively to consumers, restaurants or grocery stores within 275 miles of the farm. Sales to third-party food brokers are not exempt. However, the FDA may withdraw the exemption in the event of a direct link to an outbreak investigation, or based on conduct or conditions material to food safety.
That proposed rule, too, will have a comment period and at least three public meetings in diverse geographic areas prior to the final rule.
The FDA has already issued its proposed rule, also mandated by the FSMA, to establish minimum standards for conducting hazard analysis and implementing preventive controls for nonfarm food facilities. The comment period is now closed, and the final rule should be announced by July 4, 2012. The FDA says this rule may update its current good manufacturing practice (CGMP) regulations, or the agency may instead issue a separate regulation to comply with the FSMA.
Produce Safety Alliance
A collaborative project among Cornell University, the USDA and the FDA, the Produce Safety Alliance's (PSA) primary objective is to provide the produce industry and associated groups with training and educational opportunities related to current best practices and guidance, as well as future regulatory requirements.
The PSA is developing curricula on good agricultural practices (GAPs) and other preventive controls. Their outreach efforts will focus on small and very small farms and packinghouses. The PSA's 10 working committees cover hazards and preventive controls from farm review to postharvest handling, plus the education outreach program delivery spans farmers, trainers and regulators. Certification-related activities are also included. The committees have been communicating since May 2011.
For updates on the Food Safety Modernization Act, its progress and implementation, access http://fda.gov/fsma.
The author is a writer-researcher specializing in agriculture. She currently resides in central Pennsylvania.