Widely acclaimed as the most sweeping changes in food safety laws in more than 70 years, in January 2011, the Food Safety and Modernization Act (FSMA) was signed into law. The Act and its ensuing proposals emphasize prevention of foodborne illness, rather than combating contamination once it occurs.

The U.S. Food and Drug Administration (FDA) issued seven FSMA proposed rules during 2013 and 2014. In four of the rules, including the key produce safety rule, the FDA issued supplemental proposals with significant revisions to address numerous comments and concerns of the agricultural community and other stakeholders.

All the comment periods are now finished. While still reviewing the extensive comments and preparing the final rules, the FDA continues to plan implementation of FSMA.

The FDA’s implementation strategy aims to facilitate integrating the safety standards with agriculture’s diverse production systems of conventional, sustainable, organic, conservation and environmental practices.

Betsy Bihn, Director of the Produce Safety Alliance – Dr. Betsy Bihn brings her experience working with growers on GAPs to FSMA’s implementation efforts.PHOTO BY CORNELL UNIVERSITY


In January, FDA and the National Institute of Food and Agriculture (NIFA) of the U.S. Department of Agriculture (USDA) joined to administer and manage the National Food Safety Training, Education, Extension Outreach and Technical Assistance Program. In its announcement of the competitive grant program for this effort, the FDA said its first request for applications is for the establishment of a National Coordination Center (NCC). After NCC funding becomes available, separate requests for the regional centers will be forthcoming.

The NCC’s direction would include training curricula consistent with the produce safety and preventive controls final rules. Site visits, meetings, webinars, teleconferences and fact sheets would be included among the communication strategies.

The FDA indicated that part of this $600,000 grant will be given to those submitting grant applications to train owners and operators of small-and medium-size farms, beginning farmers, socially disadvantaged farmers, small food processors, and small fruit and vegetable wholesalers. The FDA also noted that additional investment will be required to meet the technical assistance needs for produce safety and implementation of the final rules.

Since 2011, the Produce Safety Alliance (PSA) has been developing educational materials and curriculum modules on worker health, hygiene and training; soil amendments; wildlife, domestic animals and land use; agricultural water; post-harvest handling and sanitation; and a food safety plan. In addition, PSA has met with focus groups of fruit and vegetable growers and hosted Q&A meetings and webinars with FDA staff for growers. Through their website, http://producesafetyalliance.cornell.edu, growers can access the materials, recordings, webinars and other information.

PSA is developing a grower-training program that will satisfy the requirement in the final produce safety rule for growers to receive training. In cooperation with Penn State University, PSA hosted an all-day pilot workshop at the Mid-Atlantic Fruit and Vegetable Convention in Hershey, Pennsylvania last January. Growers and educators from surrounding states participated.

Currently, PSA is also developing a train-the-trainer program and criteria for certifying approved trainers. Along with two days of classroom instruction, background qualifications are sought for the trainers.

Cornell University’s leadership in the development of Good Agricultural Practices (GAPs) and in its dissemination of food safety knowledge to the agricultural community was cited in the Agricultural Marketing Service (AMS) grant for PSA.

“In our 12-plus years of working with growers and packers on how best to implement GAPs, we have seen how much they want to do the right thing and meet the industry demand for safety,” PSA Director Elizabeth ‘Betsy’ Bihn said at the alliance’s inception.

FDA Deputy Commissioner for Foods Michael R. Taylor, referring to their collaborative effort said, “We also know that small growers and packers are especially interested in the kind of hands-on training and support envisioned by the alliance.”

PSA consists of representatives from the land grant universities, growers and shippers, produce trade organizations, USDA’s Natural Resources Conservation Service (NRCS), the Association of Food and Drug Officials (AFDO), and the National Association of State Departments of Agriculture (NASDA).

ExamSoilCore. ARS scientists Dr. Patricia Millner and Dr. Manan Sharma examine a manure-treated soil sample with FDA’s Dr. Michael Mahovic. The microbiologists are investigating the safe use of manure and compost.PHOTO: PEGGYG REB


In September 2014, FDA announced a cooperative agreement with the NASDA to provide critical information and help plan and carry out the FSMA implementation with the state regulatory agencies. In this effort, NASDA will partner with AFDO and the International Food Protection Training Institute (IFPTI). Taylor emphasized that the state partners lend expertise in food safety plus unique knowledge of local food production activities.

Senior policy and science advisor of NASDA, Bob Ehart, pointed out that the states differ widely both in their resources and regulations on food safety. In their operational plan, Ehart noted that within the federal framework, working with as few different models as possible would simplify the project and aid consistency. Comparability must be addressed, though.

“Pepper growing in New Jersey is not the same as in Wisconsin,” Ehart said.

Ehart stresses the importance of getting the right information to the right people, but while many state extension programs are underfunded, food safety educational programs require resources.

David Gombas during the produce safety hearing in Washington, D.C., Dr. David Gombas, United Fresh Produce Association, shares his ideas on the proposed rule.PHOTO: COURTESY ARS/USDA, & BOB FERGUSON


In Feburary, USDA announced $160 million in available funding for food and agricultural research, education and extension. Food safety grants of $6 million among the six program areas through this Agriculture and Food Research Initiative (AFRI) are administered by NIFA. In these grants, applications are sought for enhancing food safety through improved processing technologies and for effective mitigation strategies for antimicrobial resistance. Improving thermal and or nonthermal processing technologies for decontamination and inactivation of pathogens or preventing cross contamination during processing, packaging, transportation or storage must be addressed by applications in the improved technology area. In the mitigation strategy area, critical control points in mitigating antimicrobial resistance in the pre- and post-harvest production, and evaluating the impact of outreach interventions across the food chain are among the essential components to be addressed. In addition, food safety is one of the research priority areas in the $116 million available for the foundational program of AFRI.

The produce safety rule specifically applies to growing produce. The original proposal was outlined in the April 2013 issue of Growing (http://www.growing-digital.com/apr2013#&pageSet=4). This rule is designed to minimize the risk of serious health consequences of raw agricultural commodities. With some exemptions, those who grow and sell produce will be required to comply with this rule. The supplement to this rule revises the manure and compost applications, water usage and animal provisions. It also clarifies the definition of farms and allows for corrective action for retention of exempt status. In the case of manure and compost, the FDA has indicated that it will address the application time interval after it pursues additional risk assessments. In the meantime, the FDA says it does not intend to take exception with farmers complying with the standards under USDA’s National Organic Program (NOP).

Depending on the scope of their operation, some growers will also be required to comply with the preventive controls rule. The original proposal was discussed in the May 2013 issue of Growing (http://www.growing-digital.com/may2013#&pageSet=14) . The supplement to this rule revises the definition of ‘farm’ to no longer limit packing and holding of raw agricultural products to the farm’s produce. Also, the supplement clarifies hazard analysis, product testing and environmental monitoring.

The March 2014 issue of Growing (http://www.growing-digital.com/mar2014#&pageSet=3) briefly described the foreign supplier verification program rule, the sanitary transportation rule and the identification of high-risk foods.

FDA updates FSMA activities on its website, http://www.fda.gov/fsma. In addition, new information such as the safe use of biological soil amendments is posted. More extensive guidelines providing specific data, both prior to and after the final rules, will continue to appear.

In his fiscal-year 2016 budget request, President Obama asked Congress to consolidate USDA’s Food Safety Inspection Service and the food safety responsibilities of FDA into a new agency in the U.S. Department of Health and Human Services (HHS).

United Fresh Produce Association’s senior vice president, public policy Robert L. Guenther, commented on the proposed merger, “That the concept of a single food agency is a complicated discussion, and one not likely going anywhere at present. If Congress decides to seriously consider this, we’ll weigh in on specific options.”

Throughout the development of the proposed rules and supplements, grower-shipper and grower trade association comments and suggestions to the FDA have played a significant role.

Dr. David Gombas, senior vice president, food safety and technology for United Fresh, observes that the weakness in public health oversight is at the state and local levels, where inconsistencies in funding and resources result in even inadequate detection of foodborne illness, let alone prevention of an outbreak. Gombus cites the Center for Disease Control’s estimates that for every case of salmonellosis reported, 30 or more go unreported.

“Agriculture water testing continues to be a sticking point, more so for those operations that use surface water,” Gombas noted, regarding the produce safety rule supplement.

He said that while the FDA’s approach to testing in the supplement is better than the original proposal, it is still too complicated. However, he recognizes the current insufficiency of scientific testing and remains hopeful on the FDA’s research for the final rule. Gombas said the proposed change in which registered facilities only handle raw agricultural commodities is not substantially different from farms under the produce safety rule, creating an unfair economic disadvantage.

United Fresh suggested including those facilities under the produce rule or modifying the requirements. The association’s comments on all the rules can be found on their website, http://unitedfresh.org.

Sophia Kruszewski, policy specialist for the National Sustainable Agriculture Coalition (NSAC), commented that although pleased with FDA’s supplemental revisions, modifications are still required to ensure the regulatory framework works for sustainable agriculture and local and regional food systems. NSAC, too, said the agricultural water standard is still overly complex and burdensome. Kruszewski also noted that the preventive controls rule supplement contains a requirement for food facilities to audit their suppliers, which NSAC said is contrary to FSMA’s mandate to not require audits.

“There are many innovative food safety training programs being run by community- and farmer-based organizations in different parts of the country that can deliver training and technical assistance to these under-served groups, and it’s critical that the NIFA program be structured in a way to support and expand such efforts on the ground,” Kruszewski suggested, pointing to the NIFA-funded training program.

NSAC’s full comments can be accessed on their website, http://sustainableagriculture.net.

FDA is under a court order to issue the final rules. Their deadline for the produce rule is Oct. 31, 2015, and the date for the preventive control rule is Aug. 30, 2015.