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Dirk Dusharme @ Quality Digest

FDA Compliance

Should Food Safety Laws Apply to All Growers?

Yes—but more tools are needed for the small grower

Published: Thursday, December 16, 2010 - 04:30

For most of us, food safety is a topic that, at best, only lurks at the edges of our brains. It rarely becomes something we really think about until we open up our refrigerator and try to figure out what’s growing in the back corner of the bottom shelf, or until we hear stories about people being poisoned by leafy green vegetables or bad eggs bought at the local supermarket.

But, food safety is a huge issue. And, mostly due to the large number of food-borne illnesses in recent years, a broad food-safety bill has been working its way through Congress. The Food Safety Modernization Act (S. 510) recently passed in the Senate despite some opposition from both large and small food companies.

In part, the bill: “Requires each owner, operator, or agent in charge of a food facility to: (1) evaluate the hazards that could affect food; (2) identify and implement preventive controls; (3) monitor the performance of those controls; and (4) maintain records of such monitoring. Deems facilities required to comply with certain food-specific standards to be in compliance with this section. Requires the Secretary to promulgate regulations to establish science-based minimum standards for conducting a hazard analysis, documenting hazards, implementing preventive controls, and documenting such implementation. Prohibits the operation of a facility that manufactures, processes, packs, or holds food for sale in the United States if the owner, operator, or agent in charge of such facility is not in compliance with this section. Delays implementation of this section for small businesses.”

Oof! What a mouthful. Large food companies and associations such as United Fresh Produce Association initially supported the bill but then became vociferous opponents when an amendment was added by Sen. Jon Tester, D-MT, and Sen. Kay Hagen, D-NC, which exempted many small growers from the provisions of the bill.

Under the Tester-Hagen amendment, food producers would not be subject to new federal requirements if they sell the majority of their food directly to consumers within the state, or within a 275-mile radius of where it was produced, and have less than $500,000 per year in sales. Those producers would, however, continue to be overseen by local and state food-safety and health agencies.

In a recent press release condemning the amendment, United Fresh wrote “We are disappointed that the Senate continues to ignore the egregious loopholes allowed in this legislation that will erode consumer confidence in our nation’s food safety system. Now, when going to a supermarket, restaurant, farmers market, or roadside stand, consumers will be faced with the question of whether the fruits and vegetables offered for sale adhere to basic food safety standards or not.”

For his part, Tester argues that food safety is less an issue with small farms than it is with large ones. “[Family-scale producers] are small,” says Tester. “There’s a pride of ownership there that is real. They raise food; they don’t raise a commodity, as happens when these operations get bigger and bigger. And there is a direct customer relationship with that customer or that farmer that means a lot. And if a mistake is made, which rarely happens, it doesn’t impact hundreds of thousands of people. We know exactly where the problem was. And we know exactly how to fix it.”

Although one can sympathize with the small farmer trying to do business without the interference of “Big Brother,” Tester’s argument may not carry much weight. While scale has some effect on quality, the real bearing on quality is knowledge of quality control and quality management techniques, the means to properly implement a quality program, and the desire to do so. The problem with the food safety issue is that defective quality can quite literally mean death. And the idea that the small farmer would be any more knowledgeable on how to avoid poisoning the public than a larger farmer and should somehow be exempt may not hold much water from a quality control perspective.

That said, there is no doubt, as we have seen with ISO 9001, ISO 14001, ISO/TS 16949, GMP, and other standards, that it can be much more difficult for a small company to deal with mandated quality standards than a larger company. From a paperwork, manpower, even legal perspective, compliance to food safety regulations is much easier for a mega-producer than it is for Nancy’s Mandarin Farm, simply because it has the resources to throw at it. So the argument from Tester and others that the Food Safety Modernization Act without the amendment would be too onerous for small farmers (and might, some argue, put a few out of business) may have some merit.

However, when you are talking about the possibility of harming someone with your food product, the argument that small farms affect fewer people and that, as Tester put it, “if a mistake is made… it doesn’t affect hundreds of thousands of people” is little solace to the 10 or five or even one person that a mistake at one small farm does affect.

So what does the legislation mean for large and small companies, and how do you balance the need of public safety against the cost of doing business in a highly- (and getting more so) regulated industry?

According to Katie Dowling, a food and beverage expert at Sparta Systems, the primary and most immediate effect of the food safety bill on food companies will be increased on-site inspections, and those are a hassle no matter how big you are.

“Overall, food manufacturers and suppliers will see more FDA presence than there ever has been in the past, because the food safety bill gives the agency the authority to make recalls mandatory,” says Dowling. “In the past, recalls were voluntary procedures that varied by manufacturer. Across the industry, companies can expect the FDA to have more oversight into making recalls happen across the board.”

And unless producers quickly fall within compliance, along with increased inspections we can expect to see more recalls and, as the bill alludes to, shut-downs.

“Clearly, food manufacturers have had to deal with recalls for years, a process that costs companies hundreds of thousands of dollars in logistics and lost sales,” notes Dowling. “In the Senate version of the food safety bill, the FDA will be able to assess fines on food importers and producers who fail inspections or cannot recall foods, making once relatively minor quality issues much more expensive to address.”

What could make FDA compliance with any new or existing food-safety legislation easier is—no big surprise—standard procedures and a way to track compliance in case of an audit.

The single best thing a company can do as the food safety bill and other legislation are passed is to make sure it has the right procedures in place for upcoming inspections, explains Dowling, whose company develops quality management system (QMS) software. “Now, as in the past, when a food company can’t quickly produce information for the FDA during an audit, the risk of exposure to the business increases.”

Technology goes a long way in terms of surviving these audits, adds Dowling. The Food Safety Modernization Act increases fines for nonconformance in the industry, something that is easier to document, address, and track with automated procedures. A centralized, enterprise-level quality software system such as the type of QMS software produced by Sparta and others can greatly ease the burden of maintaining a trackable and easily auditable food safety system.

Although many manufacturers have parts and pieces of quality functionality in place, data are often spread out across a number of systems, notes Dowling. An enterprisewide QMS software tailored toward food safety provides a central, automated point for all sites and systems for quality data, including the tracking of nonconformances and corrective actions, supplier quality, and training.

Unfortunately, these types of enterprisewide QMS systems are pricey and are really designed for the large food producer or supplier. As invaluable as these tools are for the large food producer, they are most likely out of reach or inappropriate for the smaller grower. So in terms of tools, the small farmer may be limited to Excel spreadsheets, Outlook calendar reminders, Post-It Notes, and other nonintegrated tools to help keep them on top of what they need to do, if they did it, and when.

If, as Senator Tester and others assert, stricter FDA oversight is going to hamper small farms from doing business, it would seem that a stripped-down version of compliance software, priced toward the small food producer, is needed—an FDA-Compliance Lite. Small farms account for 90 percent of U.S. farming, according to U.S. Census of Agriculture, and while we believe that they must be held to the same safety standards as large farms, we also believe the quality industry should be doing what we can to provide them with cost-effective tools.

Given that the FDA doesn’t have the manpower to step up inspections, do farmers even have to worry about  enforcement? According to Dowling, maybe not in the short term. “Currently, the FDA doesn’t have nearly enough staff to conduct regular audits of food companies,” she explains. “However, part of the food safety bill includes a budget for the FDA to hire the additional manpower needed to carry out increased inspections. The agency will also likely continue to rely on state and other local agencies to carry these out.”

The Act is currently on hold, having been sent back to the House because it contained tax provisions that, constitutionally, must originate in the House. It may sit there for while because Republicans have said they will oppose anything on the House floor before addressing tax cuts and government funding matters. This gives those opposed to the bill a crack at either killing it entirely or taking out certain provisions. Most likely nothing will happen with the bill until January.


About The Author

Dirk Dusharme @ Quality Digest’s picture

Dirk Dusharme @ Quality Digest

Dirk Dusharme is Quality Digest’s editor in chief.


Should Food Safety Laws Apply to All Growers

Let's hope the bill dies.