With the Colorado-based cantaloupe listeria debacle in the news, growers at the Florida Fruit and Vegetable Association convention listened intently to Jim Gorny, the U.S. Food and Drug Administration’s senior advisor for food safety.
His assignment was to explain how the Food Safety and Modernization Act, signed into law by President Barack Obama in January, will change the FDA’s mission.
The law intends to build a new integrated national food safety system aimed at preventing outbreaks like the cantaloupe listeria catastrophe that had spread to at least 19 states and resulted in more than 80 deaths.
The Act is historic for a number of reasons. “It had bipartisan support in Congress,” Gorny says.
Supplying healthy food ought to be enough incentive to keep growers and packers on-track, he says.
“What are the incentives? There are tremendous disincentives if you do things like use raw manure. Certainly there’s a lot of stick, but not a lot of carrot.”
With the nation’s food supply system evolving quickly, outdated regulations need to change with technology, he says. More imports than ever come into the U.S.; most never undergo inspection at ports and border crossings. The FDA’s limited manpower makes it unlikely that an inspection program could ever be a significant guard against imported food-borne diseases.
“The food supply has become more high-tech and complex,” Gorny says. “There are more foods in the marketplace. Also, we are seeing a demographics shift to more older people in the population, and some of them are affected more by food-borne diseases.”
The FDA will spend more time on food imports, thanks to the new Act. “Import safety is the most groundbreaking shift under the law,” Gorny says. “For the first time, the agency will focus on importers, insuring that adequate controls are in place. We can deny entry if FDA inspection is denied. The Act requires food from abroad to be as safe as U.S. products.”
To handle the increased workload, the FDA will work more closely with state and local agencies.
“We’re going to improve foodborne illness surveillance, understanding which illnesses are occurring in the general public and how to respond to them more quickly,” Gorny says. “We will form a national agriculture and food defense policy so as to limit the damage. We’re going to take a proactive approach, as opposed to a reactionary approach.”
The agency will hold meetings and listen to comments on the new produce rule through next March. After the new rule takes effect, large farms will have a year to comply. Smaller farms may take two to three years to conform.
“The FDA is prepared for this,” Gorny says, “but there are many challenges. Much of the work we are already initiating — but there is an enormous workload at the agency. There are very tight deadlines. The changes won’t appear overnight.
“We recognize that the vast majority of produce is safe. What we’re trying to do is codify that so everybody is playing by the same rules.”
He expects produce safety regulations to involve all aspects of the industry.
“We are looking at both risk-based and commodity-based practices. It will cover growing, harvesting, post-harvesting and also packing of produce exempt from the Bioterrorism Act of 2002, enforced by the Department of Health and Human Services. We don’t need to have people being regulated under two different rules.”
The new law will regulate fresh fruit and vegetables, mushrooms, sprouts, raw peanuts and tree nuts, Gorny says.
Foods normally cooked before consumption, like potatoes and artichokes, are exempt. So, too, under the Tester Amendment, are small packers, roadside stands and farmers markets with sales less than $500,000, sold within the same state or within 275 miles of the facility. Agronomic crops like grains, sugar beets and canola are also exempt.
The produce rule does not address the issue of product traceability to the grower level. The FDA, however, does have a pilot program to identify key data in individual fields.
“We’re going to do our homework first,” Gorny says. “Traceability is important. A lot of people do a good job with traceability but it is often lost as the product goes through the supply chain.”
The new law gives FDA an opportunity to reevaluate its methods.
“What we tried to do is take a very meaningful risk-based approach. Very low risk products are exempt or out of our scope. Many small-to-medium-sized farms are exempt by the Tester Amendment,” Gorny says.
“The extent of the prescribed standards and controls varies according to the risk and the agronomic practices used — things like overhead irrigation versus subsurface drip, which varies by region. Agronomic practices change over time.”
Some practices are obvious no-nos for the FDA.
“Certain things we know,” Gorny says. “If you use raw manure on leafy greens, we know that’s a bad idea. We want to try to move people to using things like composted manure or chicken litter pellets that are less risk to the community.”
Research by the Centers for Disease Control shows that the food source for illness outbreaks cannot be identified 70 percent of the time, he says, illustrating how difficult it is to pin down problems.
“Contamination testing is driven by perception — if you start to look for it, chances are, you will find it.
“Many vegetable crops are grown at the same time. There are upwards of 40 different vegetables or types, with varying standards and controls.”
If the FDA appears to take a tough stance under the new act, it’s a necessary part of doing business, Gorny says.
“We have been forced as a public health agency to take a safe haven approach. We are very conservative.”
Crackdowns by the agency may be rare, however, at least in the near future.
“We need to educate before we regulate. We’re going to try to get people up to speed with regard to what they need to do to get in compliance with the rule. We need to take a non-traditional approach. We want to use existing government bodies and leverage the resources that are already on your farm.
“Reducing the risk of foodborne illnesses associated with fruits and vegetables is the overall goal. Looking at it from the perspective of the industry, when one farm can affect an entire industry, I expect you want rules that level the playing field.”
Gorny acknowledges that many packers already have third-party auditing programs mandated by retailers, pushing quality to high levels, and already deal with product liability.
“We’ve seen a proliferation of standards. Each retailer has different standards for risk. When, as a grower or packer, you’ve got 50 customers and they all have their own standards and they’re all right, there are certainly tremendous costs associated with that.
“What we at FDA will be setting is a floor. Pass a standard FDA-type audit and you may still have audits with regard to specific customers. We’re trying to codify what you are already doing.”
Growers and packers know all too well that when foodborne disease problems occur, the ripple effect spreads across the industry.
“Outbreaks can affect not only that one grower but the entire industry,” Gorny says. “I’ve been speaking with cantaloupe growers who say they have been economically devastated by one particular grower. This is an important issue, and we’re all in it together.”
The new Act allows the FDA to consider new ways to inspect food products. That doesn’t mean an inspector will trail every farmer, however.
“About 186,000 North American farms produce fruits and vegetables. If we took every inspector off of everything else and had them concentrate on the farms, they probably wouldn’t get it done for a decade,” Gorny says.