Although the USDA’s Agricultural Marketing Service (AMS) and the U.S. Food and Drug Administration (FDA) are separate agencies with different missions related to FSMA, they continue to share a robust working relationship with the aim to assist growers and others subject to the regulations. The seven prevention-oriented regulations issued under FSMA shift the focus from responding to food contamination after it occurs to preventing it in the first place.
Recap: Rules and Dates Regulations were finalized in 2015 and 2016 with compliance dates for the Produce Safety rule beginning in January 2018. This timeframe is effectively the first time ever that farmers who grow, harvest, pack, and ship fruits and vegetables will be regulated in these activities by the FDA, excepting large sprout-growing operations, which had to comply by January 2017.
When FSMA was passed by Congress and signed into law in January 2011, it required the FDA to draft the majority of the reports, studies, and regulations specified in the law. Two of the primary regulations are likely to impact fruit and vegetable farmers and packers, depending on the size of operation, farming activities and agricultural practices, and where their operation is located. One is the Produce Safety rule and the other is the Preventive Controls for Human Food rule.
The Produce Safety rule establishes food safety requirements for many of the farmers who grow fruits and vegetables, while the Preventive Controls for Human Food rule affects businesses that process and manufacture food for human consumption. The FDA revised its definition of “farm” in the final rules in an attempt to clarify which of the two rules may apply to fresh fruit and vegetable packing operations. Both rules provide for various exclusions and exemptions, including a de minimis exemption for the smallest categories of farms and businesses.
Collaboration and Partnerships Even before FSMA’s enactment, the USDA, FDA and other partners gave much thought and effort to establishing collaborative relationships. Because of this work, the USDA remains in position to help the farming community comply with the new FDA regulations with its many programs and services.
The AMS staff has been engaged during the development, review, and revision of the final Produce Safety rule and forthcoming guidance on how to comply with the rule. This includes education and outreach activities, technical assistance efforts with other stakeholders (such as research initiatives), as well as working with a variety of fresh produce stakeholders. These activities are in AMS’s wheelhouse, since its mission is to “facilitate the strategic marketing of agricultural products in domestic and international markets while ensuring fair trading practices and promoting a competitive and efficient marketplace” and, further, to “provide the agriculture industry with valuable services to ensure the quality and availability of wholesome food for consumers across the country.”
Although the USDA’s Agricultural Marketing Service (AMS) and the U.S. Food and Drug Administration (FDA) are separate agencies with different missions related to FSMA, they continue to share a robust working relationship with the aim to assist growers and others subject to the regulations. The seven prevention-oriented regulations issued under FSMA shift the focus from responding to food contamination after it occurs to preventing it in the first place.
Recap: Rules and Dates Regulations were finalized in 2015 and 2016 with compliance dates for the Produce Safety rule beginning in January 2018. This timeframe is effectively the first time ever that farmers who grow, harvest, pack, and ship fruits and vegetables will be regulated in these activities by the FDA, excepting large sprout-growing operations, which had to comply by January 2017.
When FSMA was passed by Congress and signed into law in January 2011, it required the FDA to draft the majority of the reports, studies, and regulations specified in the law. Two of the primary regulations are likely to impact fruit and vegetable farmers and packers, depending on the size of operation, farming activities and agricultural practices, and where their operation is located. One is the Produce Safety rule and the other is the Preventive Controls for Human Food rule.
The Produce Safety rule establishes food safety requirements for many of the farmers who grow fruits and vegetables, while the Preventive Controls for Human Food rule affects businesses that process and manufacture food for human consumption. The FDA revised its definition of “farm” in the final rules in an attempt to clarify which of the two rules may apply to fresh fruit and vegetable packing operations. Both rules provide for various exclusions and exemptions, including a de minimis exemption for the smallest categories of farms and businesses.
Collaboration and Partnerships Even before FSMA’s enactment, the USDA, FDA and other partners gave much thought and effort to establishing collaborative relationships. Because of this work, the USDA remains in position to help the farming community comply with the new FDA regulations with its many programs and services.
The AMS staff has been engaged during the development, review, and revision of the final Produce Safety rule and forthcoming guidance on how to comply with the rule. This includes education and outreach activities, technical assistance efforts with other stakeholders (such as research initiatives), as well as working with a variety of fresh produce stakeholders. These activities are in AMS’s wheelhouse, since its mission is to “facilitate the strategic marketing of agricultural products in domestic and international markets while ensuring fair trading practices and promoting a competitive and efficient marketplace” and, further, to “provide the agriculture industry with valuable services to ensure the quality and availability of wholesome food for consumers across the country.”
Working with FDA colleagues, AMS recently revised its voluntary GAPs audit verification program to ensure its alignment with the FDA Produce Safety rule, and the revised version was put into use this past summer.
Outreach Activities Providing farms with opportunities for awareness, outreach, education, training, and technical assistance supports the FDA’s “educate before and while we regulate” refrain.
In this regard, as farms strive to meet Produce Safety rule compliance dates (January 2018, 2019, or 2020 based on size of operation, with additional time for agricultural water requirements), if an FDA or state regulatory inspector finds any insignificant deficiency, the initial goal is to guide the farm towards compliance rather than take punitive actions. This is a shift from the FDA’s historical enforcement response, but the goal remains the same—ensuring growers provide reliable, consistently safe produce in the marketplace for consumers.
Collaborative efforts that support these initiatives include AMS participation in a variety of stakeholder meetings, conferences, webinars, and Produce Safety Alliance (PSA) Grower and Trainer sessions to provide information and updates on the Produce Safety rule. Most funding for PSA sessions is provided by the FDA, while AMS provides administrative oversight.
As of June 2017, there were PSA Grower Training courses in 36 different states with more than 4,200 participants; Train-the-Trainer courses in 25 states with more than 1,040 participants; and more than 145 Lead Trainers certified. Trainer applications continue to be reviewed, with 35 more lead trainer applications in the evaluation process.
The PSA website is continually updated to add new Grower and Trainer classes (upcoming courses can be found on PSA’s Training page). If there isn’t one in a specific area, local Cooperative Extension personnel or PSA staff can help find one nearby. The PSA also has training modules posted online and recently made available a Spanish language version of the curriculum. In addition, the USDA continues to review the standardized curriculum for potential updates and other improvements.
Regional Centers The FDA and USDA’s National Institute of Food and Agriculture (NIFA) have partnered to fund Regional Centers that focus on advancing the understanding and practice of improved food safety among the small and medium-sized producers and processors, broken into four regions. The four regional centers are the Northeast Center to Advance Food Safety at the University of Vermont; the North Central Regional Center for FSMA Training, Extension, and Technical Assistance at Iowa State University; the Southern Center at the University of Florida; and the Western Regional Center to Enhance Food Safety at Oregon State University.
Each regional center has partnered with a dozen or more land grant institutions across the region and in the District of Columbia and U.S. Territories. The regional centers have also liaised with state and local regulators as well as community-based and nongovernmental organizations to maximize training effectiveness and delivery opportunities.
Evolving Technical Assistance The FDA is focusing on providing technical assistance in a variety of ways. There are preparations for guidance documents that, once issued, should help farmers and packers better understand how to comply with the regulatory requirements in the Produce Safety rule.
Guidance includes additional clarity and more commodity/agricultural practice examples farmers and packers can reflect upon as they think through applying these practices to their own unique operations. In addition, AMS has reviewed most of the early versions to provide feedback and content.
The Produce Safety Network (PSN) is a cadre of FDA staff stationed around the country. As they become familiar with the various commodities, conditions, and practices within their regions, AMS staff is providing resources for PSN leaders to familiarize themselves with local, regional, and state commodity groups; USDA research and promotion boards and marketing order committees; land grant university experiment farms; and AMS federal program managers across the nation.
The FDA’s “Building the Produce Safety Network” webpage provides an overview of the PSN and a map showing regions and proposed staffing.
Under Review Biological soil amendments of animal origin requirements in the Produce Safety rule warrant continued consideration. To this end, AMS and the USDA Natural Resources Conservation Service participated in a “Soil Summit” meeting held earlier this year and hosted by PSA.
The meeting provided the FDA with many other sources of information and farmer perspectives on the use of manure and compost. A summary document, which includes a discussion of research results and risk assessment activities, farmers’ use of various biological soil amendments within production systems, and priority areas within the scope of this Produce Safety rule provision, will be available for consideration by the FDA.
The approach related to agricultural water requirements within the context of the Produce Safety rule continues to evolve. The FDA published its final rule, which addresses various components of agricultural water requirements including a sanitary survey, qualitative and numerical standards depending on the use of the water, as well as sampling and testing frequencies depending on the water source, indicator organism, test methods, and corrective measures. The FDA also provided two additional years for compliance with some of the water requirements.
Even with this additional time, farmers and trade organizations put forth a range of potential challenges in meeting the water requirements. So AMS staff participated in a narrowly focused meeting convened by the Center for Produce Safety and Western Growers Association, which produced the “Report on Agricultural Water Testing Methods” (which can be found at www.centerforproducesafety.org) for review and consideration by the FDA.
Last summer, the FDA also announced its intent on the FSMA website to “revisit” the agricultural water requirements. The announcement indicates the FDA’s intention to extend the compliance dates for agricultural water requirements (other than for sprouts) and use the extended time period to work with stakeholders as it considers developing a more workable solution that also protects public heal-th. Be sure to visit the FDA’s FSMA web page for updated information or to submit questions or comments.
What’s to Come Compliance dates will be here before you know it and AMS has been working with partners at the FDA, the National Association of State Departments of Agriculture, and Cooperative Extensions on the “On-Farm Readiness Review [OFRR] Work Group” to develop a program to help farmers better understand their compliance status before an official inspection takes place.
The Work Group is currently piloting the OFRR, which should be available on a voluntary basis in the coming months. Farmers exempt from the Produce Safety rule may also find the OFRR useful as they make decisions related to market access. Contact your state department of agriculture staff, Cooperative Extension specialists or the USDA to get more information on the OFRR and learn how it may be helpful to assess your Produce Safety rule compliance status.
The role USDA continues to play in helping farmers prepare for eventual compliance with the FDA’s produce safety regulation (and any other FDA regulations they may be subject to) is diverse and dynamic. It is well worth repeating that AMS looks forward to continuing its engagement with the FDA on behalf of the nation’s fruit and vegetable growers and packers.
