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Monitoring Food Safety from Farm to Fork

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Food Production Safety

BALTIMORE—The Food and Drug Administration is increasingly harnessing data-driven, risk-based targeting to examine food processors and suppliers under the Food Safety Modernization Act. At this week’s Food Safety Summit, the FDA’s Roberta Wagner, director of compliance at the Center for Food Safety and Applied Nutrition, emphasized the risk-based, preventative public health focus of FSMA.

While it has long collected extensive data, the agency is now expanding and streamlining analysis from inspections to systematically identify chronic bad actors. FSMA regulations and reporting are revolutionizing many of the FDA’s challenges, but so is technology. According to Wagner, whole genome sequencing in particular has tremendous potential to change how authorities and professionals throughout the food chain look at pathogens. WGS offers rapid identification of the sources of foodborne pathogens that cause illness, and can help identify these pathogens as resident or transient. In other words, by sequencing pathogens (and sharing them in Genome Trakr, a coordinated state and federal database), scientists can track where contamination occurs during or after production.

At the same session, Jorge Hernandez, senior vice president of food safety and quality assurance at US Foods, also highlighted the importance of thorough risk evaluation and data-driven analysis for food companies. He encouraged a farm to fork approach to managing food safety and quality assurance risks, examining data as far back as possible so that companies just face the burden of maintaining safety, not combating or passing on contamination. Developing standards or suppliers that rest on a foundation of data and testing is the first step, but then companies must also be ready to check for compliance and implement change.

The primary components of the food chain are standard: producers, processors, suppliers/distributors and operators. Between each, however, comes the opportunity for monitoring and verification checks that should serve as control points, Hernandez said. These controls must be integrated into every link in the chain, and food companies must constantly evaluate what systems are necessary to ensure success downstream.

Q&A: Food Safety Modernization Act

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The Food Safety and Modernization Act (S.510) of 2010 is the first major overhaul of the FDA’s food safety provisions since 1938. And after a year that saw recalls of numerous processed foods, meats and eggs (check out the nine major snafus of the decade according to the Huffington Post), an overhaul food safety regulations is exactly what Americans need. To better understand the new act, I contacted Bernie Steves, managing director of Aon Risk Solutions’ crisis management practice, and Rick Shanks, national managing director of Aon Risk Solutions’ food system, agribusiness and beverage practice.

Will there be an expected increase in the number of recalls as a result of the legislation? If so, why?

BS & RS: Aon expects the number of recalls to increase if the proposed legislation becomes law. The FDA will be able to insist on a recall based on “reason to believe” rather than providing credible evidence of the contamination. We are already seeing an influx in recalls. To date, recalls have been on a voluntary basis and increasing for several years.

What are some examples of new regulatory requirements for manufacturers, importers and distributors as outlined in the Food Safety and Modernization Act?

BS & RS: A full hazard analysis will be required, identifying and evaluating known or reasonably foreseeable hazards that may be in association with the facility. These include an extensive list of hazards specifically given as examples in S.510. The hazard analysis must include food defense, which identifies and evaluates hazards that may be intentionally introduced by acts of terrorism. A full plan will need to be developed.

What implications will these new regulations have on recall insurance?

BS & RS: Food companies will need to reevaluate coverage, limits, terms and conditions. Studies show that the average recall costs $10 million, not including damage to brand.  Several insurance markets have been able to include government recall as an endorsement to product contamination policies. Certainly those endorsements will be more applicable in the U.S. with the passage of this legislation. It is important to note that while this authority to order recalls is new in the U.S., many countries’ local food safety authorities have had this power. For instance, the EU has had similar legislation since 1999.

What effect will these regulations have on risk managers in the food production and distribution industry?

BS & RS: Underwriters will require more detailed information on processes, controls, loss prevention, crisis management and product development. Aon advises risk managers to be involved with quality assurance, food safety, food defense and supply system risk management in both manufacturing and distribution for wholesale and retail.

Though this bill has enjoyed strong bipartisan support, it is not yet finalized. When can we expect the Food Safety and Modernization Act to be put into action?

BS & RS: Experts advise that the normal process between the House and Senate may delay the passing of the legislation. Some reports say that the House may streamline the process.

Up Next for Congress: The Food Safety Bill

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Now that the financial reform bill, one of the most important bills in history, has passed through Congress, many lawmakers are now focusing on something just as important: the Food Safety Modernization Act.

The bill, S.510, aims to “amend the federal food, drug and cosmetic act with respect to the safety of the food supply.” In other words, it will expand the power of the FDA, enabling regulators to be more vigilant in preventing food contamination. One key supporter of S.510 is Congressman John Dingell (D-MI), who held a briefing May 19 to call for the swift passage of the bill, citing recent E. coli outbreaks linked to romaine lettuce. Also on board for the passage of the bill is Congresswoman Rosa DeLauro (D-CT), who issued a public statement last week.

“The American people continue to be at risk from dangerous outbreaks while critical food safety reform legislation, which includes provisions that would be helpful in addressing a widespread outbreak through preventive controls and interventions, remains stalled in the Senate, Congresswoman DeLauro said Friday. “I urge the Senate to act quickly before more people become victims of contaminated food and our faulty food safety system–the longer the food safety bill is delayed, the more vulnerable our food safety system remains.

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And delayed it has been. The bill was first introduced in March 2009 and the last reported action regarding the reform was in December 2009 when it was put on the legislative calendar.

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Since then there have been numerous food recalls and food contamination illnesses reported.
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The most recent widespread recall focused on raw alfalfa sprouts produced by Caldwell Fresh Foods of Maywood, California. The sprouts have allegedly sickened at least 22 people in 10 states.

Contaminated food kills at least 5,000 people in the United States every year, puts more than 300,000 in the hospital and costs the nation around $152 billion. To not pass the Food Safety Modernization Act would be like giving the green light careless food manufacturers — in essence, giving them a license to kill.

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