The Food and Drug Administration will kick off a multiyear process requiring farmers to get hazard-prevention and water-testing plans in working order when it publishes final rules for produce safety early next month.
Enforcing the new requirements under the Food Safety Modernization Act of 2011 will force the agency to figure out how to best deploy its overwhelmed corps of safety inspectors.
Leaders of California’s Leafy Greens Marketing Agreement say they have an answer, at least for their corner of the industry. “We’ll do that job for them,” Scott Horsfall, the alliance’s president, told CQ Roll Call.
The farm group, which is funded by industry but is part of California’s Department of Food and Agriculture, exists to ensure that the greens grown in California are safe for human consumption. It also exists to help California farmers sell their lettuce, like a number of agricultural marketing agreements that exist around the country.
The rule is one of seven major regulations the FDA must implement as a part of the food safety law, which responded to a series of high-profile foodborne illness outbreaks. The LGMA believes the growers it oversees are already in compliance — and they’d like the FDA to recognize their certification as equal to its own. Other groups with similar goals are watching to see what the agency will allow, despite concern in some quarters that regulators could get too cozy with industry.
“We don’t want exemptions. We don’t have any opposition to the rules they are putting in place,” Horsfall said. “We’re just trying to show them that as an industry, we’ve already put a program together.”
The new rules for produce will require training in safety and hygiene for anybody who handles produce, and will set new standards for testing water and treating soil. The LGMA standards are specifically optimized for growing leafy greens grown in California and appear to satisfy or exceed what the FDA will require.
“In many areas, the LGMA standards are more stringent and prescriptive than the proposed FSMA regulations,” said Trevor Suslow, a professor at the University of California, Davis, who studies produce safety.
After an E. coli outbreak caused by infected spinach in 2006 killed three and sickened hundreds, California’s leafy green growers didn’t waste any time.
“In the circumstance we were coming from, we were highly motivated to create a system,” said Ron Ratto, a farmer and the LGMA’s chairman. By the alliance’s estimate, the spinach outbreak cost up to $250 million dollars in lost sales and disposal costs.
The LGMA was formed in 2007, and the vast majority of California’s leafy green farmers are members. Each company is audited every two months of active crop production, plus one more unannounced audit, resulting in at least four per year. The audits are paid for by the industry, but carried out by the state or state-certified third-party inspectors.
Rep. Jeff Denham, R-Calif., whose district contains many Central Valley farmers, encouraged the FDA to work closely with industry to come up with compliance standards. “The LGMA’s exemplary food safety standards are a great example of industry taking it upon themselves to ensure the highest quality produce in California,” he said.
There is optimism the FDA will seriously consider an arrangement with the LGMA. Under the 2011 law, states can propose variances from the produce rule if they are necessary because of local growing conditions and the FDA finds the substitute provides the same level of protection.
But there is concern that partnerships make it too easy for the industry to make its own rules and put public health at risk. Despite a partnership with the Interstate Shellfish Sanitation Conference, the FDA has been unsuccessful in efforts to restrict oyster harvesting in waters that contain the bacteria vibrio, which causes dozens of deaths each year.
“We have seen time and time again, in all industries from financial regulation to food safety, that when you let the industry regulate itself, the American public are the ones who get hurt,” Rep. Rosa DeLauro, D-Conn., said.
The FDA offered some direction recently, when it released guidance on training for FSMA rules. Since 2010, it has created three alliances made up of regulators, industry and academia. These alliances are developing training programs and working with the FDA to develop best practices for implementation of the new rules, including the produce guidelines. Partnerships such as this, however, are only effective when the FDA maintains that “they are not ceding their regulatory authority to these organizations,” said David Plunkett, senior attorney for food safety at the Center for Science in the Public Interest.
The growers of other commodities whose organizations aren’t state-based hope the LGMA is successful and that the FDA might consider similar commodity-based arrangements.
Specific commodities usually have their own safety standards known as “Good Agricultural Practices.” In the LGMA’s case, compliance with its rules are mandatory, but for other produce following these practices is usually voluntary.
Laura Phelps, who oversees government relations for the American Mushroom Institute, noted that if mushroom growers were already in compliance with the institute’s own GAP standards, they wouldn’t have much to worry about when it was time to become FSMA-compliant.
“The farms that have implemented food safety plans that meet the M-GAP and other standards will not have any problems with the FSMA produce rule,” she said.
David Gombas, the head of food safety for the produce industry group United Fresh, thinks partnerships such as this could help establish a single set of guidelines for producers to follow.
“For somebody who is under LGMA, there is the question of ‘Will I satisfy FDA?’” he said. “Rather than allow that confusion to exist, this would make it a lot easier, a lot cleaner.”