A preview of the 2011 Food Safety Act


The majority of U.S. growers, and almost every processor and packer, will, at one point or another, fall under the provisions of the new Food Safety Modernization Act passed in January.

Firms downstream from the farm will be required to comply with a host of new food safety requirements.

The U.S. Food and Drug Administration (FDA) is responsible for implementing the Food Safety Modernization Act, which was signed into law on January 4, 2011, explains Robert L. Guenther, senior vice president of public policy for the United Fresh Produce Association, Washington, D.C. This is the bill known as HR 2751 or SB 510.

The measure was designed in response to a rash of food recalls that peppered the landscape in the past 10 years – commodities ranging from spinach to peppers to eggs were subject to recall notices.

Whether you are a grower, processor, packer or retailer, the act will affect you. According to consultants at PricewaterhouseCoopers and Leavitt Partners (PWC), the act gives the FDA expanded authority and ability to monitor the safety of the food supply and to take quicker and more effective action against companies that don’t adequately protect against food contamination.

PWC, in its report “Point of View: FDA Food Safety Modernization Act,” says it is “the most sweeping overhaul of food-safety legislation since 1938.” The FDA will have expanded access to records if there is reasonable belief that food handled by a facility is adulterated. In addition, the FDA is mandated to perform increased inspections for all registered facilities. The FDA will have mandatory recall authority.

The 2011 act has not yet fully gone into effect, because the requisite rule making has not begun. The National Farmers Union (NFU) will participate in the notice and comment period to ensure that the implementation of the act does not “entail additional costs that would unfairly burden family farmers,” says NFU President Roger Johnson. There are other hurdles.

“First of all, Congress needs to fund the bill, and some representatives in Congress have threatened to withhold funding,” notes Stacy Miller, executive director of the Farmers Market Coalition (FMC), Cockeysville, Md.

“This is an authorization bill, not an appropriations measure,” says Ferd Hoefner, policy director for the National Sustainable Agriculture Coalition (NSAC), Washington, D.C.

“Most things in the bill cost money,” Hoefner adds, noting that funding for those items is not yet in place (see sidebar).

“Clearly, produce regulations must be [the] FDA’s top priority,” Hoefner says. “After that, it is not clear where they will go.”

The FDA has to develop science-based standards for produce that enters interstate commerce. This will also cover new certification requirements for imported food that is determined to be high-risk. Companies will need to provide assurance that the food they import complies with the Food, Drug and Cosmetic Act.

“It will take up to three years to implement this new law, which will include 12 new regulations and 10 different guidance documents for the food industry,” Guenther says. “For fresh produce, the new law will impact the entire distribution chain, from farm to table. This includes growers, shippers, importers, wholesalers and retail.”

PWC agrees that all these groups will face new mandates for food safety.

“There are now more requirements for food processing and marketing companies to use hazard analysis and preventive controls, along with additional inspections and other responsibilities that may increase short-run costs for processors but will prevent future expenses from foodborne outbreaks and recalls,” Johnson says.

Show Me The Money

While the Food Safety Modernization Act is law, the funds to make it run are yet to be provided by Congress. The Republican appropriations staff has made it clear that there is no money for increases. In fact, their stated goal is to roll spending back to FY 2008.

“It would not shock me if we were in 2013 having debates on whether to fund parts of the bill,” says Ferd Hoefner.

He says a return to FY 2008 funding would be “devastating” to the FDA, noting that while mandatory recall is a policy and could be enacted cheaply, other provisions like more inspectors, inspections in foreign countries and at ports of entry all require money.

Some money may be gained from belt-tightening. However, most observers see little fat in the budget as it exists.

At this time, the new provisions of the law have not gone into effect. “Over the next 18 months, [the] FDA will be developing new rules and regulations, recording and establishing minimum standards for the effective implementation of preventive control requirements, sometimes known as food safety plans, for each registered facility,” Guenther says.

This could have a major impact on growers’ relationships with customers.

Under the new regulation, each registered facility would be required to conduct a hazard evaluation to identify known or reasonably foreseeable hazards. These include “biological, chemical, physical and radiological hazards; natural toxins; pesticides; drug residues; decomposition; parasites; and unapproved food and color additives,” and “hazards that occur naturally or may be unintentionally introduced,” as well as hazards that “may be intentionally introduced, including by acts of terrorism” and implement preventive controls (including at critical control points, if any) to provide assurances that the identified hazards would be significantly minimized or prevented.

While some provisions of the act are aimed at anti-terrorist activities, United Fresh Produce Association says it is not aware of any instances where terrorist activities threatened a fruit or vegetable operation.

Still, they anticipate there may be some compliance challenges. “I think the farther you are removed from a ‘facility’ or something with four walls [the more] challenges for the fresh produce industry,” Guenther says. “It will be important to consider current requirements and make sure they are applicable in farming operations.”

Neither is the NFU aware of any incidents involving its members.

The law will require importers to verify that their foreign suppliers have controls in place, according to Section 805 of the act. This must be done by January 4, 2013. The FDA likely will promulgate implementing regulations over the next 12 to 18 months.

“The act calls for greater communication between the USDA, the Food and Drug Administration and the Department of Homeland Security to coordinate their efforts in the event of terrorism or any other dangers within our domestic food supply, although it does not mandate any particular arrangement,” Johnson says. He says he believes stronger lines of communication between these agencies will only help to ensure our domestic food safety.

Some bogus rumors

One persistent, bogus rumor that has made the rounds on the Internet says that the act would do away with organic growers and make it illegal to have a home garden. One version of the message claims it would “effectively criminalize organic farming.” While the act does require minimum safety standards for organic produce, it certainly does not outlaw organic goods. In fact, it simply clarifies the Food and Drug Administration’s requirements for food safety.

Another claim of the e-mails is that Rep. Rosa DeLauro introduced the bill because her husband works for Monsanto. That is patently false, since Stanley Greenburg (DeLauro’s husband) works for a research and polling outfit that has not done any business with Monsanto in over a decade, according to the researchers at Snopes.

“There have been some persistent but factually challenged viral e-mails circulated that claim the act would lead to the demise of everything from organic production to backyard gardens,” Johnson says. “This is simply not true.”

Johnson notes that exceptions were included in the act to better suit the realities of small farms that do not pose a systemic risk to our food supply.

“I don’t believe that this act portends the end of small-scale or organic production, though we’ve been pummeled with rumors to that effect,” says Miller, noting that the Tester-Hagan Amendment – for which the FMC and the National Sustainable Agriculture Coalition helped negotiate language – creates size-appropriate requirements and less-costly compliance alternatives.

The amendment put forward by Sens. Jon Tester, D-Mont., and Kay Hagan, D-N.C., exempts farms from many of the requirements of the act if two criteria are met: the farm has less than $500,000 in annual gross sales, and more than half of the product is sold to consumers or retailers in-state or within 275 miles of the farm.

“This clarification is especially important for off-farm retail locations, such as farmers’ markets,” Miller says.

Tester-Hagan also provides a size-appropriate and less-costly alternative to Hazard Analysis and Critical Control Plans (HACCP) for smaller growers who direct- market more than half of their products directly to consumers, stores or restaurants.

“This amendment demonstrates how the act makes distinctions between the risk level of small farms as compared to large agricultural production and processing centers,” Johnson explains.

“Given the exceptions that have been included in the act, and the upcoming opportunities for public comment on the implementation of the new regulations, there is no need for the concern that the act will put small farmers out of business,” Johnson says.

Guenther cites a more practical reason why small producers are not really in any danger of being zapped by the law. “I think all produce operations already take food safety very seriously,” he says.

“Food safety is part of the current business environment for produce,” he continues. “Having an effective food safety plan could mean the difference between success or complete destruction of a business. It should not matter how big or small you are, or what growing practices you implement, food safety must be a fundamental part of our business plan.”

In fact, produce growers and packers did a pretty decent job of keeping produce safe well before this law was even a gleam in the legislators’ eyes. Back then, Guenther says, he might wish the industry did a better job of selling its knowledge and safety to the public and to Congress. He says he would have liked to have seen “more education of the policy makers about the intense level of food safety practices already being applied by the industry.”

It is a good lesson to learn, and one that the entire food chain should emphasize the next time it holds a legislative roundtable or takes its annual trip to Washington, D.C., to talk policy with lawmakers.

There is no guarantee that complying with the minimum standards of the act will keep a grower or packer out of hot water, PWC consultants note. Outbreaks can still happen. “Your customers expect the food you produce, sell or serve to be safe. And that expectation is likely to rise. Setting a higher standard will help your company achieve its mission of better serving customers,” they say.

Some farmers, for whom direct marketing accounts for a small proportion of their sales, may be impacted, Miller says. “Until [the] FDA begins drafting rules, and offers the public opportunities to comment, we won’t know for sure,” she says.

“I don’t think farmers’ markets will be directly impacted at all in the 2011 season,” Miller continues, although the FMC encourages farmers’ markets to develop and put guidelines in place for food sampling, cooking demonstrations, hand washing amenities and live animals.

“Proactive measures to prevent contamination at the farm and market levels are good business, and help ensure the viability of farmers’ markets,” Miller says. “We also strongly encourage farmers and farm market managers to develop and strengthen relationships with local and state health departments so that they are at the table in helping ensure that rules applying to farmers’ market products are appropriate to scale and level of risk.”

The biggest thing is for those farms that know they will be categorized by the FDA as “facilities” to get working on a food safety plan. Despite the exclusions, there are a lot of growers who will be above the line of demarcation.

“If they don’t have a plan, they should get started, even if we don’t know the particulars of the new law,” Hoefner says.

For example, growers and packers need to be sure their records are electronic, not paper. They have to be sure they track the date and time a lot was harvested, and that data has to be available to share with other businesses up and down the chain.

To that end, Hoefner hopes that, at a minimum, the USDA gets funding for a good training program. That should be doable – the training provision of the act was one of the few areas that got support across the board from all constituencies.

Once the act is implemented, the result, Guenther expects, will be a better understanding of what will be agreeable standards for fresh produce in the future. “Over three years, we will have a strong federal commitment as a partner in ensuring those producing in the commercial marketplace are adhering to basic food safety standards,” he says.

Curt Harler is a freelance writer and a frequent contributor. He resides in Strongsville, Ohio.