According to produce industry experts, there are no real surprises in the lengthy proposed rule for produce safety, which has been widely hailed as a big step toward a preventive food safety system. For the most part, the proposal, which would for the first time mandate preventative practices across the industry, follows well known best practices and the best available science. What may surprise consumers, however, is that an estimated 79 percent of growers will be exempt from the rule once it’s finalized. There are estimated to be 190,111 domestic farms that grow produce (including 475 that grow sprouts), according to an impact analysis study conducted by FDA. Of these farms, an estimated 149,561, or nearly 79 percent, will not be covered by the produce rule because they grow products that are rarely consumed raw, make under $25,000 annually or qualify for a small farm exemption. The FDA estimates that only 40,211 produce farms and 285 sprout farms are fully covered and would have to “implement all of the standards outlined in the proposed rule.” Extrapolating from FDA’s calculations, these farms likely produce about 85 percent of the produce responsible for causing foodborne illnesses. According to the agency, about 90 percent of produce acreage grown and consumed by Americans would either be covered by the rule or be exempt because the product is consumed cooked or sent to food processing plants “designed to address biological hazards associated with produce.” Produce Marketing Association lobbyist Tom O’Brien told Food Safety News he thinks the scope of the exemptions — caused in part by the Tester amendment, a provision sponsored by Sen. Jon Tester (D-MT) to exempt small farms that sell mostly locally — will become “more controversial” as people realize just how widely they will apply. The Tester provision sparked a fierce debate when Congress was considering the Food Safety Modernization Act in 2010. The fight pitted produce giants like Chiquita and Del Monte against the likes of the National Sustainable Agriculture Coalition and supporters of farmers markets who wanted smaller farms to be exempt from new, potentially costly regulations. Congress ultimately adopted the exemption, which applies to farms making less than $500,000 on average each year (for at least three years), and who sell more than half of their produce directly to consumers (anywhere) or to retailers or restaurants within the same state or a 275 mile radius of their farm. At the time, the Tester amendment also splintered consumer groups. Food & Water Watch, for example, decided to support the exemption, while the Center for Science in the Public Interest and others in the Make Our Food Safe Coalition remained firmly opposed to it. Those opposed argued that all farms, regardless of their size, should have to follow basic preventive practices because bacteria don’t discriminate based on the size of the operation. Costs vs. Benefits While the vast majority of farms will likely be exempt from the rule when it takes effect, which will happen in a few years, the FDA estimates there will be a significant impact on the marketplace. The economic and public health benefits of the proposed rule are estimated to outweigh the costs, which are significant for produce growers. The FDA estimates that the proposed rule would cost the domestic produce industry about $460 million per year. Including the costs to foreign growers, that number rises to around $630 million. The average cost per farm is $11,430, but the costs are estimated to be quite different based on size. The FDA estimates that the initial average cost for complying with the proposed rule for small farms would be $20,470; for large farms it would be $38,133. The average recurring costs to industry, the agency estimates, would be $10,507 for small farms and $24,401 for large. Even farms that are exempt would incur some costs for learning the contents of the rule and figuring out which parts may or may not apply to them. For example, if a farm qualifies for an exemption because they grow potatoes — which are rarely, if ever, eaten raw — or because they grow tomatoes that are primarily processed into canned tomato sauce, it would still need to keep documentation on which company received its product. According to FDA’s analysis, there are around 3.1 million illnesses each year that are attributable to produce, which makes the total potential benefit of eliminating all of these illnesses about $1.88 billion. FDA says the proposed rule covers about $1.61 billion of this estimate, indicating that the agency believes the vast majority of the farms linked to known illnesses would be covered by the measure. “We do not expect that we will eliminate all dollars’ worth of foodborne illness,” reads the analysis. “The effectiveness of this regulation and the corresponding reduction in food contamination and foodborne illness will depend on how successfully the standards are implemented.” FDA estimates that the rule, if implemented correctly, would reduce the human health burden associated with produce by nearly 65 percent, which comes to about $1.04 billion. Compared to the estimated costs to industry, the net benefit is expected to be about $576 million annually. One of the most interesting pieces of FDA’s analysis is the assumption that neither FDA nor states will face increased inspection costs as a result of the produce rule. “We believe that the rule’s benefits of reduced produce contamination can be achieved without adding any additional resources to inspection to ensure compliance with the rule.” The FDA said in the document it is seeking comments on that assumption. Industry Outreach “At first wash, everyone is in agreement that [the draft rule] is consistent with our best practices,” said Ray Gilmer, vice president of communications at the United Fresh Produce Association. Gilmer said that United Fresh experts were not surprised by the contents of the draft rule, which they read with great interest as soon as it was made public on Friday after a year-long delay. After consulting with working groups for various commodities, the group will comment on how the rule can be improved or clarified. The question for many farms will likely be: How far away are they from these best practices and how much will it cost to get there? Michael Taylor, Deputy Commissioner for Foods and Veterinary Medicine, the architect of FDA’s food safety overhaul, told Food Safety News last week that if produce growers are already employing good agricultural practices (GAPs) and are getting “serious certifications” there my not be much they need to change. The agency is also working to ensure that the regulations are flexible to different commodities. “What I think we’ll see, especially in the produce community, where standards are new is that we’re going to need to work with the community to explain what we’re proposing and to explain how the flexibilities work, said Taylor. “There are many, many examples of where we’ve built flexibility into the rules so the requirements are adaptable to the particular circumstances of a farm: what they’re growing, how they’re growing it, the way they use water, and so forth.” Taylor said FDA wants to do extensive technical assistance and industry outreach, which includes building stronger partnerships with state departments of agriculture. Of course, this type of work will take manpower and resources, two factors about which FDA officials and stakeholders remain seriously concerned. The story has been updated to clarify the Tester exemption for direct sales is not bound within geographical limits and to make it clear that while the majority of farms will likely be exempt, FDA estimates 90 percent of produce is either covered, not consumed raw, or processed in a way that reduces the risk of foodborne illness. Also updated to include more links to more information.