Riding out the ripple effect of FSMA

With the compliance dates for some of the rules of the Food Safety Modernization Act (FSMA) already in effect and others coming nearer day by day, many produce growers are just beginning to realize the impact the rules will have on them and the changes they will need to make. However, says Produce Safety Alliance Director Elizabeth Bihn, “FSMA is not a meteor that showed up out of nowhere just because it’s new to you; food safety requirements have been evolving over time.”

That evolution began with the 1998 FDA Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables. Alongside other regional and university programs, the National Good Agricultural Program (GAPs), funded through a grant from USDA and FDA, began creating educational materials to help growers understand and implement Good Agricultural Practices (GAPs) in 1999. Unfortunately, over the years, buyer requirements for food safety practices have not been consistently applied, Bihn says.

In the early years, the pressure was extremely variable; some buyers required their suppliers to follow GAPs, but if there was no one implementing the program for the produce they needed, they would buy it anyway, she explained. “So, it’s been difficult for farms to know if they need it or not,” Bihn says. Additional produce-associated outbreaks, such as the 2006 spinach outbreak and the 2011 cantaloupe outbreak, resulted in more consistent requests from buyers for food safety practices on farms and in packing houses, but requirements are in no way universal.

It is for exactly that reason that FSMA can be such a challenge, because if a farm never had an exposure to food safety with GAPs, it can be very difficult to understand and apply the rules of FSMA. It also is for that reason that PSA set up a working group to focus on small and very small farms. (See The Produce Safety Alliance on page 26 for more information on PSA.)

This may seem to be an inconsistency since many small and very small farms are exempt or excluded from FSMA rules, but just because a farm is exempt doesn’t mean that its buyers won’t require compliance. “This is why we feel like every grower, subject to the rule or not subject to the rule, needs to understand it. Even if you are not subject, you could easily end up with buyers requiring it,” Bihn explained, adding that auditors also are likely to start aligning their audits with the rule.

While FSMA’s Produce Safety rule is that which is most applicable to growers, there are provisions of other rules which are applicable to some growers and/or are causing a ripple effect, particularly the Sanitary Transportation rule and the supply-chain requirements of the Preventive Controls rule.

Following is a brief overview of each of these rules and how they impact growers.

Preventive Controls Supply-Chain Program

Manufacturing/processing facilities must have a risk-based supply-chain program to ensure control of hazards in raw materials and other ingredients when the control is applied before receipt (“supply-chain applied control”). This would include, as applicable, use of approved suppliers, supplier verification activities, and documentation (which could include onsite audits, sampling and testing, records review, and other appropriate activity). While the rule does not require that farms’ compliance with the produce safety rule be verified, it does require that facilities that process products covered by the rule, such as fresh-cut produce, have the supply-chain program.

To minimize the burden on suppliers that are small farms, the receiving facility of produce from exempt produce suppliers does not need to comply with supplier verification requirements if the supplier provides written assurance, at least every two years, that the raw material or ingredient is produced in compliance with applicable FDA food safety regulations and is not adulterated under the FD&C Act. However, the rule states, “The ultimate responsibility for supplier verification rests with the receiving facility through its determination in approving suppliers and in reviewing and assessing applicable documentation provided by another entity.” Additionally, for any raw material or ingredient for which a hazard requiring a supply-chain-applied control has been identified, the receiving facility must have a risk-based supplier program.

Sanitary transportation

Prior to FSMA, food transportation was federally regulated only by the Department of Transportation, which had no rules for the safety of the food being transported. But, because of food-illness outbreaks from unsanitary practices and contamination in transportation, there have long been concerns about the need for regulation. Thus, FSMA’s Sanitary Transportation rule establishes requirements for transportation vehicles, equipment, operations, records, training, and waivers. It applies to shippers, receivers, loaders, and carriers who transport food in the U.S. by motor or rail vehicle.

The goal of the rule is to prevent practices during transportation that create food safety risks, such as failure to properly refrigerate and/or protect food and lack of sanitation.

The rule does not apply to shippers, receivers, or carriers with transportation operations with less than $500,000 in average annual revenue or food fully enclosed by a container (except if requiring temperature control). Additionally, transportation of raw agricultural commodities (RACs) to processing facilities are excluded if performed by a farm, however the produce safety rule does include requirements that transportation equipment be clean and adequate for use.

In fact, while comments to the rule requested that post-farm transportation requirements be included in the Produce Safety rule instead of in the transportation rule, FDA disagreed, stating that the transportation rule is more inclusive, applying to all foods and all forms of contamination, not just the biological hazards of the produce safety rule. Thus, FDA said in the rule, “We believe it is most appropriate to establish requirements related to transportation of produce after it leaves the farm in this rule.” That said, FDA recognized the diversity of farms and their transportation operations, thus the exclusion of transportation by farms.

The full text of the Sanitary Transportation of Human and Animal Food is available at bit.ly/2k9jFMk

A complex rule

To adjust to and compensate for the complexities of the food industry and its supply chains, the various rules of FSMA are intended to be integrated and have a certain extent of crossover. However, this bridging of the rules also carries with it its own complexities. As Bihn explains, it can be very confusing to growers who are conducting value-added activities on the farm, as this could make them subject to other parts of FSMA such as the Preventive Controls for Human Food (PCHF) or for Animal Food rules as well as the Produce Safety Rule.

She provides as an example, a farm that grows and packs its own blueberries, and packs some blueberries for a few small neighboring farms. As long as the farm owns and is packing a majority of its own produce, it falls under the Produce Safety Rule. But what happens if the grower has a bad year, and the amount it is packing for its neighbors becomes the majority of the packed produce?

“Growers should understand the definitions and practices that are governed by each rule,” Bihn says. “They may not realize that some practices can put them under the Preventive Controls rule.” That is, if you’re conducting value-added activities that include minimal processing, you may fall under the PCHF, making the farm subject to both rules.

Make your voice heard

It is just such questions that make it so critical that growers be informed and understand the rules, Bihn says. Compliance to the Produce Safety Rule does not take effect until 2018 for large farms, with longer timelines for small and very small farms and for the water rules. Guidance has not yet been issued. So, while encouraging growers to not panic and work on doing what you can, Bihn says, “It’s also important for growers to consider the way the practices can benefit the farm besides food safety.” For example, implementing the required worker training could lead to less worker turnover, which leads to better employees, which means easier management. “It’s easy to look at the cost and the hassle, but it’s also important to say, ‘How else can I benefit from doing this?’”

She also recommends that growers use the time to become informed, which is particularly important because growers still have a chance to have their voices heard. “When guidance comes out, there is a comment period, and you have a vested interest to comment on what you can and can’t do,” Bihn says. “But without being informed and part of the process, you don’t have a voice.”

Lisa is the editor of sister publication Quality Assurance & Food Safety (QA) magazine. llupo@gie.net