3 Lingering Issues with Produce Safety Rule

There remain some issues to be resolved with the U.S. Food and Drug Administration’s final Produce Safety Rule under the Food Safety Modernization Act (FSMA). Although some facets of the proposed rule were changed to the industry’s satisfaction, the mechanics of adjudging producer compliance have yet to be laid out. In addition, the water rule remains contentious. Safety Rule

The final rule was published on Nov. 27, 2015. The National Sustainable Agriculture Coalition said it contained some welcome clarifications; operations that primarily market directly to consumers, like roadside stands, farmers markets and community supported agriculture (CSAs), will not have to register with the FDA. Also, use of a location, like a pickup site for CSA boxes of produce, will not require the location to be registered.

There are also exemptions based on size; farms with average sales of under $25,000 are not covered, and there is a qualified exemption for those with sales of under $500,000, provided more than half its sales are direct to consumers or to local end users.

How many exemptions is too many?

Are there too many exemptions? “Time will tell,” said Michael Doyle, Ph.D., director of the Center for Food Safety at the University of Georgia. “The Chipotle E. coli problem is an example of the potential problem with small, local farms being sources of contamination. There have been a few outbreaks associated with small farms, but our Centers for Disease Control and state health departments continue to improve their way of detecting outbreaks, and it’s gotten so incredibly good now with Listeria we’ve had three or four major outbreaks where they’ve identified 10 to 20 cases of listeriosis that, in a few of these outbreaks, go all the way back five years.”

He said with a robust database of whole genome-sequenced isolates, the FDA can compare a sample taken from a field or plant and see whether its fingerprint matches one gathered recently by a state health department. That never happened with Chipotle; authorities never pinpointed the ingredient in its food causing the norovirus and E. coli outbreaks that plagued the restaurant chain for two months last fall.

Although the “vast majority” of U.S.-consumed produce will be covered by the rule, even exempted entities are going to be expected to comply with federal standards, according to Samir Assar, Ph.D., director of FDA’s Division of Produce Safety. “We’ve got guidance, recommendations, for all growers to implement,” Assar said. “There’s a Good Agricultural Practices guidance we issued back in 1998 that we’re looking to update, so there are resources out there for producers to follow, even if they’re not subject to the rule.”

“The produce rule in its final form is very similar to the Good Agricultural Practices,” said David Gombas, Ph.D., senior vice president, food safety and technology for United Fresh Produce Association. “And that document was built on the best information available in industry…the same major risk factors are the risk factors in the produce safety rule. There [are] a few additions but they’re minor by comparison, and there’s nothing in the produce safety rule that is likely to be size dependent.”

But large growers, he said, have likely been compliant with the new rule for years, because the major market chains to which they sell have required them to have GAP-consistent audits.

“Smaller operations that didn’t have to go through audits in the past may struggle a little bit complying with the produce safety rule, but I don’t anticipate that being a major factor,” Gombas said. “There’s a couple of things that they will find difficult to comply with, things that maybe they’re doing differently today, but they have two years or longer to comply.”

Time to get compliant

With the exception of sprouts growers, farmers have two to four years depending on size to become compliant with most of the rule, and four to six years for the water requirements. “One thing to keep in mind is that we are committed to educating before and while we actually regulate,” Assar said. “We understand that for some farmers, these standards will be new to them, so we have dedicated resources to facilitating education and training around the produce safety rule, and around produce safety in general. We’ve worked to develop alliances through Cornell, and we’re also working with other educational entities to offer education to the community at large.”

Assar said the FDA is “working on kind of a compliance approach in which the states and local governments will play a big role, and so the approach will involve inspections after the rule becomes effective and the compliance dates hit.” He won’t comment on the level of resources the agency and its state cooperating agencies will need to conduct the inspections. “I’d say the states are going to play a major role with conducting inspections,” he said. “And there are other opportunities that we’re providing out there for states to carry out some of the inspectional activities that will need to happen.”

Doyle said it’s not that simple. “There [are] questions about third party auditors, and that’s another rule. The FDA’s going to have to have more inspectors itself for oversight, and part of the problem is, is there enough money in the budget to hire all these people? More and more money is being made available for maybe not all the inspectors the FDA feels it needs to be hired, but there will be substantially more than they’ve ever had,” he said.

“It’s going to be a process,” Gombas said. “In many states, it’s the state department of agriculture that is seen on the farm. In many states, those individuals have built a level of trust among farmers. There’s no doubt about it – there is a fear of regulatory oversight in an industry that’s never had to do that before, and so I think it was wise for the FDA to engage the National Association of State Departments of Agriculture and try to build an approach where the state departments of agriculture will be the ones doing the inspections for the produce safety rule.” For the FDA to do the inspections itself, he said, would more than double the number of operations that the agency is currently responsible for.

Water and the rule

Pertaining to water, the rule will need extra compliance time, according to Doyle. “If it’s pumped right out of the ground from a deep well, then it probably isn’t going to be a serious problem. If it’s surface water that might have wildlife as potential sources of external contamination, that’s going to be a much bigger challenge.”

“It’s the first time that FDA has required microbiological testing of an input as a preventive control,” Gombas said, and it’s something that most growers have never done before – although he said the standards will be familiar to companies that are part of the California – Arizona Leafy Greens Marketing Agreement (LGMA). One change from the proposed rule was from a testing requirement every seven days to a risk management approach, and that was applauded by the LGMA.

FDA’s standard for E. coli in irrigation water mirrors the EPA’s recreational water standard. Gombas noted the organism dies off quickly in the field, and the rule reflects that by giving the producer credit for time after final irrigation to allow die off on the produce. While the amount of testing and calculations necessary for a farmer to make will be new, “They need to know the level of contamination that may be present in that water because if you irrigate produce with contaminated water, there’s a good chance that that produce itself may end up being contaminated if it gets to the consumer,” he said. Gombas acknowledged water testing will be important, but said the FDA could have chosen a simpler approach.

“The produce rule requirements around water are ridiculous, and they’re not going to make the food safer,” said Steve Warshawer, a grower from outside of Santa Fe, New Mexico. “I believe that as written, they threaten to end irrigated agriculture in New Mexico in terms of specialty crop production, period.”

Warshawer describes himself as a small family farmer, and runs a diversified operation with vegetables, cattle, eggs and cheese. When United Fresh started its Harmonized GAP Initiative in 2009, he was named to the Technical Working Group and has also served on the Calibration Committee, which works on consistency of implementation and interpretation for that standard.

He described the water requirements under the produce rule as absurd. “The pathogens that we’re concerned about are ubiquitous to, actually, everywhere so when you do environmental testing, all you do is prove what we already know,” Warshawer said. “The fact that it’s out there doesn’t mean it’s going to get to anybody’s food and make them sick.” He said while the agency has offered techniques to allow use of water that has failed pathogen benchmarks, like the post-irrigation presumption of die off, “that doesn’t change the fact that all of the money you’re spending proving whether or not you hit the benchmark is money that’s gone.” He said if FDA won’t change the water regulations “substantively and voluntarily,” he hopes they get changed in the courts.

But despite what he sees as a fatal flaw in the water testing requirement, Warshawer calls the rest of the rule sound, and said in some ways it’s easier to understand than the existing GAP guidelines. “What I really like about the produce rule is the emphasis on risk-based analysis and risk-based thinking,” he said.

He said the produce rule is even less proscriptive than the GAP standard, because it tells the grower to address the risks without directing the performance of a risk assessment. “The first requirement in any GAP standard is a food safety plan,” Warshawer said. “A food safety plan is generally organized to address the control points in the standard. The produce rule doesn’t require a food safety plan. It sure would be smart to have one; it makes it easier to demonstrate what you’re doing for compliance.”

Doyle said the rule addresses most of the primary sources of pathogen contamination that can be associated with produce, but may fall short with wildlife, although he said, “That’s a complicated issue, and it’s hard to regulate.” Many growers have already made major investments on wildlife deterrents like noisy cannons and fences, and Assar described the rule’s approach to animal intrusion as “very light-handed.” He said, “The standards are not directed towards the animals themselves, per se – it’s more towards the produce that’s impacted by the animals. If there is a sign of animal intrusion, such as animal feces on the actual produce, then the farmer is required to not harvest that produce and put it in the marketplace. There are no requirements for fencing or destruction of wildlife.”

The big question is whether the new rule will make a dramatic impact in foodborne illness incidences; Gombas is skeptical. “I’ve seen statements in the press about folks saying, ‘Yes, this will prevent outbreaks; this will reduce illnesses,’ even FDA’s own statements about this reducing hundreds of thousands of illnesses each year,” he said. “I don’t believe that’s going to happen.” He does suggest there may be a large amount of grower compliance that will improve consumer confidence and food safety, but won’t stop all the outbreaks. “At the end of the day, fresh produce is fresh, and it’s still going to be vulnerable to whatever wind and wildlife brings over the fence.”

But Doyle is more optimistic that the rule can make a dramatic difference in incidents of food poisoning. “It depends on whether FDA’s going to have enough money to fully implement what its plans are,” he said. “Frankly, I think the surveillance system that I described” – the federal and state agencies using the genome database – “is going to have the greatest impact. It’s going to force companies to really invest in a food safety culture to prevent problems from occurring, and those that don’t still get it will ultimately get caught if they have problems.”

Read more: Basic food safety for the grower

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