WASHINGTON, Nov. 25, 2015 - The arrival of the Food and Drug Administration’s 800 pages of new regulations on how producers should grow and harvest fresh produce is generating only a smattering of groans and complaints from the farm sector.
Hammered out with a ton of feedback from affected parties and scores of revisions over recent years, what’s called “the produce rule” earlier this month became the fifth completed set of regulations mandated by the 2010 Food Safety Modernization Act (FSMA).The rule will impose a lot of food safety practices, which could be burdensome especially on small farms where adding new monitoring, testing and commodity handling practices will be costly. The rule’s coverage, however, was also whittled down extensively and its compliance timeline pushed back, especially for small operators.
The rule particularly targets crops that pose the highest risk of pathogen contamination. Edible sprouts are especially vulnerable to dangerous microbes because they are grown in very warm, moist conditions, so large farms producing them will have just one year to fully comply with a separate set of regs addressing that crop. Plus they’ll have the earliest deadlines to establish a water purity testing system. Meanwhile, however, the rule excludes crops, including tubers and grains, that aren’t usually eaten raw, plus exempts all farms that average less than $25,000 a year in produce sales.
Sophia Kruszewski, food safety analyst for the National Sustainable Agriculture Coalition, thinks a lot of small operators will look at the broad commodities exclusion and decide to grow more exempted crops and less of the regulated ones to stay beneath either the $25,000 benchmark or, alternatively, an under-$500,000 sales category that offers some leniencies. “I expect there will some shifting in what producers are deciding to grow,” as compliance dates approach, she says.
The NSAC remains irked that the $500,000 cap is applied to sales of all farm products edible to people or livestock, rather than just the fresh produce covered by the rule. “For farmers looking to diversify – whether in the number of crops, or both crops and livestock – and sell produce locally, this limitation is going to be a significant disincentive to do that,” Kruszewski says.
Michael Taylor, FDA deputy commissioner for foods and veterinary medicine, told Agri-Pulse this week, however, that Congress was clear in specifying that this qualified exemption includes all food. “We didn’t have any legal leeway to take into account only produce,” he said.
In general, major producer groups take a tolerant and cooperative view of two major parts of the rule: water purity standards and use of manure fertilizer.
At California-based Western Growers (WG), whose members grow nearly half of U.S. fresh produce (including a third of organic), Senior Vice President Hank Giclas says WG worked closely with FDA, and the final rule “gives us the clarity we need to continue working with growers, processors, packagers and shippers” to ensure continued good food safety practices. For example, he says, “FDA appears to provide more flexibility (than proposed earlier) with regard to water testing frequency as well as the use of historical data to confirm a testing regime, moving away from a one-size-fits-all approach.” He says FDA’s planned on-line implementation guide and calculator to verify compliance with water testing standards will also be helpful.
What’s more, Sonia Salas, WG’s science and technology director, believes that most large WG farms “are in essential compliance” already. “For operations that already have water testing regime in place . . . there’s not going to be a significant change. They’re already testing, they have a (testing) frequency and their indicator is the same one the FDA is requiring now.” However, “for the ones who don’t have something (for water testing) in place, there’s going to be a cost.”
In fact, some farmer groups think the water standards will cost small operations needlessly by imposing the same purity standard to irrigation water as to water that’s used to wash produce, for example, which is the same as that applied nationally for water safe for swimming. That standard is too severe for irrigation water, says Judith McGeary, who heads the Farm and Ranch Freedom Alliance, and “is going to be very damaging for the growing-local food movement.”
Meanwhile, FDA’s requirements for use of manure and compost on fields is viewed broadly as farmer friendly. First, the rule requires farmers to inspect fields for recently applied manure from farm or wild animals, but delays any prescribed intervals between manure application and harvest until further research is completed on how long pathogens in manure survive in the field.
Realistically, don’t expect FDA to post a mandated interval for five to 10 years, experts advise. But in the meantime, FDA recommends continued observance of the National Organic Program’s regs on application of raw manure – which prescribe no harvest for 90 to 120 days after application. Taylor says FDA will decide in 2016 whether to codify those intervals as an interim step. Further, the agency scratched minimum waiting periods after field applications of compost, largely at the insistence of organic farmers.
Farm groups welcome FDA’s focus on training and technical assistance for producers. Salas notes, for example, that WG represents producers of all sizes and production methods, including organic, and is finalizing tools and training opportunities for all of them.
Taylor says the expansive plans for training and technical assistance will start off well in the next year only if Congress doles out the $109.5 million the agency said it needs to implement the new law. “Without it, implementation will be seriously disrupted and delayed,” he says.
The agency has already launched its FSMA Food Safety Technical Assistance Network to assist industry, regulators, academia, consumers and others on FSMA implementation. It is also moving ahead with its cooperative agreement with the National Association of State Departments of Agriculture (NASDA) to get state agencies on track with the produce rule. And it’s collaborating with the Produce Safety Alliance, a joint creation of Cornell University, FDA, and USDA, plus others in a network of institutions to provide technical assistance on the produce rule to the farming community, especially small and very small farms.
Finally, note the compliance deadlines: January 2018 for most provisions of the produce rules and for most farmers, but three years for small farms ($250,000 to $500,000 in annual sales), and four years for very small farms (under $250,000 in sales), though most farms get an extra two years to establish a water testing regime.
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