Tag Archives: FDA

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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.

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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.

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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.

Superbugs in Your Supermarket Chicken

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The use of antibiotics in animal feed has been widely publicized in recent years, with studies presenting alarming evidence of the amounts and types of drugs used and their effect on consumers. A new study, however, sheds an even more alarming light on the situation.

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Canada’s CBC TV recently launched an investigation, which found that a whopping two-thirds of samples of chicken found at major grocery stores in some of Canada’s biggest cities has bacteria resistant to at least one antibiotic.

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As the study asserts, this is not unusual. What frightened researchers was the fact that some of the bacteria found were resistant to six, seven or eight different types of antibiotics.

“This is the most worrisome study I’ve seen of its kind,” said Rick Smith, the head of Environmental Defence, a consumer advocacy group.

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But, as Wired science blogger Maryn McKenna points, out, this is not a problem with only Canadian meat, it is a worldwide problem. She points to an annual report published by the U.S. Food and Drug Administration, which “monitors the prevalence of antimicrobial resistance among foodborne bacteria, specifically, Salmonella, Campylobacter, Enterococcus and Escherichia coli.” Their findings are not far off from those of Canada’s CBC TV.

The following is just one chart from the report showing the prevalence of resistant bacteria in store-bought meats:


The problem for us humans lies in the fact that routine use of antibiotics on farms contributes to the surge in antibiotic-resistant infections among people. And, as Grist writer, Tom Philpott points out, “MRSA — an antibiotic-resistant staph infection — now kills more Americans than AIDS.”

This topic seems to be of little concern to the FDA, and seems even less worrisome to the CDC. So if the two organizations that are supposed to fight for food safety and disease control and prevention are putting forth little, if any, effort, who will protect us?

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.

The Mets Are Trying to Give You Salmonella

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Mets Citi Field

Like clockwork, the New York Mets fill their fans with heartache every September. Now, it looks like they’re trying to get an early start on some stomach aches, too.

According to ESPN’s list of stadium “vendor inspection reports,” Citi Field is rife with health code violations, at least one of which included a bunch of warm, raw chicken being stored on premises

Citi Field
New York Mets
Vendors with critical violations: 45%
Inspection report excerpt: Inspectors found 20 pounds of grilled chicken registered at 70 degrees in a refrigerator, about 30 degrees warmer than allowed.

Yuck.

But the Mets are far from the worst offenders. The Consumerist has compiled it’s “Top 10 Disgusting Stadium Food Vendor Health Violations.” (I presume they mean the “top” 10.)

Look what’s going on in Miami — in a stadium named after an insurance company no less.

Sun Life Stadium
Miami Dolphins, Florida Marlins
Vendors with critical violations: 93%
Inspection report excerpt: In June 2009, an employee complained anonymously that small insects and other debris were blended into frozen alcoholic beverages at a stand where equipment wasn’t being cleaned. When inspectors checked, they issued a critical violation for a buildup of slime inside the frozen drinks machine.

I guess the lesson here is to stick to the peanuts and Cracker Jacks.

In related news, Claire Wilkinson of the wonderful III blog Terms + Conditions just wrote an interesting post on food safety. Focusing on an op-ed from this Sunday’s New York Times urging Congress to improve standards and grant more authority to the FDA.

While the elderly and people with compromised immune systems face an elevated risk from food borne pathogens like listeria, campylobacter and salmonella, by far the most vulnerable group are children under the age of four.

The economic cost of the problem is also huge. A recent study sponsored by Pew Charitable Trusts puts the total annual health-related cost of food-borne illness in the U.S. at about $152 billion.

Schlosser notes that legislation in the Senate would give the Food and Drug Administration (FDA) the power to order the recall of contaminated foods and punish companies that knowingly sell them. It would also improve the FDA’s ability to trace outbreaks back to their source.

No word, however, on whether or not the FDA can help the Mets crawl back into the Wild Card race.