Tag Archives: Focus Article

OIG Says FDA Recall Initiation Process Not Efficient or Effective

By Food Safety Tech Staff
No Comments

As a result of an ongoing audit of FDA’s food recall program, the Office of Inspector General (OIG) has concluded that FDA does not have the policies and procedures in place to ensure that voluntary food recalls are initiated in a prompt manner.

“This issue is a significant matter and requires FDA’s immediate attention,” the letter stated. “We suggest that FDA update its policies and procedures to instruct its recall staff to establish set timeframes for (1) FDA to request that firms voluntarily recall their products and (2) firms to initiate voluntary food recalls.”

The audit follows a report from June 2011 that reviewed FDA’s monitoring of imported food recalls. That particular report also found the agency’s food recall program to be inadequate due to the fact that FDA did not have the authority to require companies to recall certain foods. FSMA has changed this aspect of recall authority.

The OIG’s letter, addressed to FDA Commissioner Robert Califf, M.D., specifically calls out two recall cases:

  • A nut butter recall due to Salmonella in which 14 people became ill. According to the OIG, 165 days passed from the time FDA identified the adulterated product to the time the company initiated a recall.
  • Several recalls of cheese products due to Listeria monocytogenes in which 9 people became ill and one infant died. In this situation, 81 days passed from the time FDA was aware of adulterated product to the time the company recalled the products.

The OIG issued the letter to Califf as an early alert. The audit of FDA’s food recall process is continuing and the OIG will be issuing a draft report at the conclusion of the audit.

Gina Kramer, Savour Food Safety International

Industry’s Responsibility to Protect Consumers from Listeria

By Maria Fontanazza
1 Comment
Gina Kramer, Savour Food Safety International

The ubiquitous nature of Listeria has made it a difficult pathogen to detect, control, and find its root cause. Led by Gina Kramer, executive director of Savour Food Safety International, attendees of last week’s Listeria Detection & Control Workshop learned everything from the cost of Listeria ($1.4 million per case and $2.3–$22 billion in the United States annually) to the challenges of breaking down biofilms to the steps a company should be taking to do sanitation right and get rid of resident Listeria in their facility. Here’s a snapshot of what experts said as they addressed industry’s obligation to ensure that their facilities are constantly monitored for contamination to ensure that safe product comes out of their plants.

People equate local and organic with safer, safer, safer. That’s not true, because pathogens are agnostic. ­– Gina Kramer, executive director, Savour Food Safety International Gina Kramer, Savour Food Safety International
John Besser, CDC Whole genome-based outbreak detection allows us to detect more quickly, with greater precision in identifying source — John Besser, Ph.D., Deputy Chief, Enteric Diseases Laboratory Branch, CDC
 What’s happening in your plants? What are you taking into your processing plant? What time of year is it coming in? What is your environment—is it more urban or rural? The presence of Listeria isn’t any greater in an urban or rural environment. You might find it in different places, but there isn’t a difference in incidence.  – Janet Buffer, corporate food safety manager, The Kroger Co.  Janet Buffer, Kroeger Company
Dominique Blackman, Realzyme  Biofilm erupts like a volcano. But once it has erupted, your volcano goes dormant. And for how long? Nobody knows. That’s the problem. The biofilm can release two days later, a week, or a month later.  – Dominique Blackman, general manager, Realzyme
 Listeria testing is the ugly duckling in preventive controls. Companies need to ask themselves whether the method they use is able to detect potential positives in the environment. – Ted Andrews, senior director, product marketing, Roka Bioscience  Ted Andrews, Roka Bioscience
 Jeff Mitchell, Chemstar Sanitation is not one size fits all. You need to have specific controls in place that look at controlling Listeria not just for equipment but periodic infrastructure and equipment and routines. Validate that they work. Train employees so they properly execute.  – Jeff Mitchell, vice president of food safety, Chemstar
 You’ve identified Listeria in your facility.  Now what? Review touch points: This includes the air, surfaces, transportation and packaging areas. – Troy Smith, CEO, Radiant Industrial Solutions, LLC  Troy Smith, Radiant
 11_FSTListeria_DougMarshall If you get everything mostly right, what are the odds that you’ll find a pathogen in end product testing? Getting the proper data point is a big deal. – Douglas Marshall, Ph.D., chief scientific officer, Eurofins

 

John Besser, Listeria conference

Deadly Outbreaks and the Role of Metagenomics

By Maria Fontanazza
No Comments
John Besser, Listeria conference

Americans consume 350 billion pounds of food each year, with one out of six people falling victim to foodborne illness, and 3000 dying. The significant amount of Listeria outbreaks hitting the industry (most recently, the staggering number occurring in produce) has left many food safety and quality assurance professionals searching for better methods of prevention and detection. Using big data, specifically metagenomics, to improve food safety and detect potentially deadly outbreaks is indeed where the future is headed.

DID YOU KNOW? The estimated U.S. cost of one case of Listeriosis is $1.4 million. Listeria is a prime concern due to the high percentage of fatalities that occur as a result of contracting Listeriosis. And what’s worse is the fact that many of the cases are preventable.

During Food Safety Tech’s Listeria Detection & Control Workshop this week, John Besser, Ph.D., deputy chief of CDC’s Enteric Diseases Laboratory Branch, outlined how the agency is leveraging metagenomics to find unrecognized problems in the food supply. Perhaps the most important element of disease surveillance is that it enables the detection of new issues, especially those whose presence was previously unknown.

John Besser, Listeria conference
CDC’s John Besser, Ph.D. discusses genome-based outbreak detection work at the agency. (Click to enlarge)

Pathogen-specific surveillance allows the detection of more outbreaks, which will in turn make the food supply safer, because it will enable industry to understand the root causes of outbreaks and help them address problems much sooner. The CDC is focused on genome-based outbreak detection because of its ability to achieve faster detection—and with greater precision in identifying the source. The method has also helped the agency solve outbreaks with fewer cases occurring, and it concurrently helps rule out sources.

PulseNet, a nationwide database (comprised of 87 labs in the United States) that links cases most likely to share a cause for illness, has prompted food safety improvements across a variety of products, including sprouts, peanut products, leafy greens, flour, melons, eggs and poultry. Combine this capability with the Listeria initiative, which was launched in the mid-2000s, and the CDC has been able to find more (and smaller) outbreaks than ever before. In fact, there’s been a dramatic increase in the number of outbreak cases that have been solved (with the food source being identified). During the pre-whole genome sequencing (WGS) stage (September 2012­–August 2013), only one outbreak was solved; in year one of the WGS project (September 2013–August 2014), four cases were solved; in year 2 of the WGS project (September 2014–August 2015), nine outbreaks were solved. In these respective time periods, the median number of cases per cluster dropped from six to four to three. In addition, the number of cases linked to a food source jumped from 6 to 16 to 93 during this respective time period.

Besser also discussed the role of metagenomics, or the study of total genetic material recovered directly from environmental samples. A couple of years ago, this was science fiction and wasn’t possible, he said. But as we look to the future, metagenomics will become a lot cheaper as computers become more powerful—and at break-neck speed. He referenced IBM Research, who earlier this year announced a project being conducted in conjunction with Mars, Inc. and Biorad for sequencing the food supply chain (calling it the “largest-ever metagenomics study”).

Read Food Safety Tech’s interview with IBM Research about the next-generation sequencing project, “Preventing Outbreaks a Matter of How, Not When”

Metagenomics enables the profiling of communities of microbiomes anywhere in the food supply chain. And the method is fast—it can potentially shave weeks off the process of identifying clusters of interest. In addition, it can increase the value of interviews conducted with patients who have fallen ill (Think about it: Do you remember what you ate two weeks ago? What about a month ago?).

Currently there are several limiting factors surrounding metagenomics: Cost; sequencing read length and error rate; specific software (and pipelines); computing processing power and bandwidth; and the signal-to-noise factor. However, with the rapid rate in which technology has been improving in this space, the high likelihood of these issues being addressed and resolved in the not-so-distant future will present exciting opportunities in outbreak prevention and detection.

Randy Fields, Repositrak
FST Soapbox

Insurance and Food Safety: A Primer for the C-Suite

By Randy Fields
No Comments
Randy Fields, Repositrak

Food safety risk is now a greater concern for retailers and manufacturers than ever before due to the combination of FSMA and increased consumer concerns. Supply chains are more complex, product recalls and foodborne illness outbreaks occur more frequently, and the new normal is prevention rather than inspection. Wrap that all up with advanced technology and the 24-hour news cycle, and consumers are acutely becoming aware of food safety issues as soon as they occur.

What this means for all of the participants in the global food supply chain is that you should review your insurance policies and look for gaps in coverage where you may be exposed. While no two recalls are the same, and foodborne illness outbreaks impact affected companies in different ways, certain trends have emerged to help better understand the claim friction points that frustrate companies after a food safety event.

Two of the most important tools to mitigate food safety risk are contaminated product insurance (CPI) and product recall insurance (PRI). Inventory, cost of refunds and recall expenses are three of the largest recall loss items suffered by companies. Combined, they are the largest percentage of loss (nearly 50%) and represent a substantial portion of uncovered loss for any insured under CPI/PRI. The sole basis for this frustrating friction point is simple—lack of traceability.

CPI/PRI only covers losses that result directly from a covered insured event. If a company is unable to support its claim that costs are directly related to the event and the resulting recall or outbreak, it will not be reimbursed under a CPI/PRI policy. And, as such, loss amounts are generally not covered under general liability and property policies either, so a significant portion of a company’s loss remains uncovered.

Here’s a recent claim example to illustrate the impact on a company that lacked the capability to properly trace its products. An insured purchased a CPI policy with a $2 million Accidental Contamination limit. An event occurred involving a contaminated food product, which triggered that coverage. During the review, the insured provided spreadsheets supporting nearly $1.1 million in customer credits for product shipped and either returned by the customer for disposal or destroyed by the customer. Unfortunately, based on a review of the information provided in support of the spreadsheets, the accountants found that the insured was unable to properly trace and support its claim that the returned or destroyed product was affected by the insured event recall. Under these circumstances, the accountants were only able to confirm $187,000 in losses. The result: The company was unable to recover nearly $1 million in potentially covered losses because it lacked traceability. These outcomes are not uncommon.

The insurance industry understands food safety risks and the need to evolve products to meet the needs of food industry clients. Companies can’t totally mitigate all food safety issues, but understanding the risks is the best way for a business to protect itself. Insurance industry leaders are working in partnership with their food sector clients to ensure that risks are better understood and that the client has appropriate systems in place to help mitigate them.

Insurance companies are tailoring their products to ensure that policies are developed to address the recall risks caused by regulatory changes and help companies ensure compliance as well as an understanding of the regulatory requirements. However, food companies may increasingly find coverage and limits adjusted lower for government recalls in high-risk environments. Insurers are also a key player in the promotion of food safety standards, and some offer favorable rates to food industry clients who are graded top tier for safety.

Some insurers go a step further, allowing clients to allocate a portion of their premium for pre-incident risk-analysis and crisis-response services. Top insurers provide clients access to a network of crisis management specialists as part of their food safety coverage. They should offer risk management guidance in areas such as food safety risk, regulatory compliance, supply chain management and product security.

One of the most critical risk mitigation tactics is developing long-term relationships with trusted, but verified, suppliers, distributors and other key partners. It is also important for companies to undertake regular site visits to their manufacturers or suppliers, and commission third-party audits to maintain reliability and transparency.

Not if, but when a product recall occurs, a company faces a myriad of risks. As with food safety, preventive planning can pay off significantly. By proactively working with insurers, trading partners and technology vendors you can reduce if not eliminate the negative impact of the event.

FSMA

FSMA Intentional Adulteration Rule Released

By Food Safety Tech Staff
No Comments
FSMA

–UPDATE (5/27/2016)– The final rule has been published on the Federal Register‘s website. –END UPDATE–

FDA just released the final FSMA rule, “Mitigation Strategies to Protect Food Against Intentional Adulteration”. Under the rule, domestic and foreign food facilities must complete and maintain a written food defense plan that assesses their vulnerabilities to intentional contamination.

“Today’s final rule on intentional adulteration will further strengthen the safety of an increasingly global and complex food supply,” said Stephen Ostroff, M.D., incoming FDA deputy commissioner for foods and veterinary medicine in a press release. “The rule will work in concert with other components of FSMA by preventing food safety problems before they occur.”

The final rule will be published on the Federal Register tomorrow. To preview the PDF document, visit the Federal Register’s website.

FDA

FDA’s Annual Food Registry Report Finds Listeria and Allergens as Top Issues

By Food Safety Tech Staff
No Comments
FDA

Yesterday FDA released its Reportable Food Registry (RFR) and cited Listeria monocytogenes as generating the greatest number of reports (223), along with undeclared milk (27), in Year Five (from September 8, 2013–September 7, 2014).

FDA defines a reportable food as “an article of food/feed for which there is a reasonable probability that the use of, or exposure to, such article of food will cause serious adverse health consequences or death to humans or animals.” The purpose of the registry is to allow FDA to track patterns of food and feed adulteration in order to help the agency focus its already limited inspection resources.

Year Five saw 909 reportable food entries, including 201 primary reports regarding safety concerns with food or animal feed and 464 subsequent reports from suppliers or recipients of food or feed that was the subject of the primary reports, and 244 amended reports. The following food safety hazards were identified within the 201 primary reports in Year Five: Drug contamination, pathogenic E. coli, Listeria monocytogenes, nutrient imbalance, lead, Salmonella, undeclared allergens and undeclared sulfites. In addition, Salmonella, Listeria and undeclared allergens made up about 88% of the total primary entries for all five years of the RFR.

The report’s complete breakdown of the RFR submissions by year, along with identified commodities and hazards, is available on FDA’s website.

International Brotherhood of Teamsters

Supplier Accountability Focus of Latest Protest Against Chipotle

By Food Safety Tech Staff
No Comments
International Brotherhood of Teamsters

The labor union International Brotherhood of Teamsters has been holding nationwide protests at Chipotle locations this month, taking issue with one of the restaurant chain’s suppliers. The supplier at the focus of the demonstrations is California-based produce company Taylor Farms, which supplies tomatoes and peppers to Chipotle, according to Teamsters.

“Over the past five years, Taylor Farms has had more than 20 food recalls for problems such as Listeria, Salmonella and E. coli. In November 2015, Taylor Farms products containing celery and sold at Costco and other retail outlets were recalled for possible E. coli 0157:H7 contamination,” according to a Teamster news release. “At Taylor Farms’ plant in Tracy, Calif., the company has also committed safety and health violations and violations of laws that protect workers’ rights. Recently, the company settled extensive labor rights violations that involved payments of $267,000 to illegally terminated workers and a required posting in which the company promises to never again violate a long list of employee rights.”

The Teamsters protested at 12 Chipotle locations across the country, following 30 previous protests at Chipotle over the past several months.

Teamster Vice President Rome Aloise points the finger at Chipotle for allowing Taylor Farms to “have a total disregard for consumers’ and workers’ health and safety, as well as workers’ rights,” he said. “Chipotle claims to serve ‘Food With Integrity’, but where’s the integrity when it turns a blind eye to its supplier’s behavior? Chipotle must not cut and run – which would hurt Taylor Farms workers – it must carry out its social responsibility and demand Taylor Farms treat workers fairly and with respect.”

Taylor Farms has not released a statement addressing the protests.

North American Meat Institute Fires Back at Burger Report Findings

By Food Safety Tech Staff
No Comments

As Clear Labs’ latest report on burger products, The Hamburger Report, has gained widespread media attention, the North American Meat Institute is sounding an alarm about the findings. Clear Labs is a “fledging company” that is “up to its same old tricks”, using burgers as its target just in time for the grilling season, said Betsy Booren, Ph.D., vice president, scientific affairs at the North American Meat Institute, in a statement from the organization.

Read the article on Food Safety Tech: Next-Gen Sequencing Exposes Problems with Burgers

“A review of the company’s procedures suggest[s] collection methods prone to mistakes and a range of errors throughout the analysis process. A look at the company’s own promotional video featuring shots of overpacked freezers and technicians testing products using plastic forks and knives with paper towels would suggest cross contamination in the lab is a very good possibility,” said Booren. “When a single cell can generate a finding, precise methods are crucial. It’s entirely possible that the human DNA found could be linked back to the company’s own staff—we just don’t know.  Likewise, when the lab company suggests some products showed the presence of another species, like chicken in a beef product, this finding could also stem from a single cell and even result from the pulling samples from multiple packages in the same room, as the company appears to have done.”

Booren called Clear Labs’ report a marketing ploy and went on to assert that today’s ground beef is safer than ever, saying there have been significant reductions in pathogenic bacteria, which has been “further confirmed by this report [The Hamburger Report]”.

Clear Labs, The Hamburger Report

Next-Gen Genomic Sequencing Exposes Problems with Burgers

By Maria Fontanazza
1 Comment
Clear Labs, The Hamburger Report

Burgers are the quintessential American food. But as prices continue to rise in the beef industry and U.S. consumers seek more health-conscious alternatives such as veggie and salmon burgers, some food companies may be cutting corners. Clear Labs used next-generation genomic sequencing (NGS) to conduct molecular analysis of 258 burger products (ground meat, frozen patties, fast food burgers and veggie burger products from 79 brands and 22 retailers) and found significant issues—instances of substitution, missing ingredients, pathogens or hygienic problems—in about 14% of samples. This is a red flag for industry, indicating a need to remain vigilant about vulnerabilities in the supply chain and the way in which products are tested.

Ironically, perhaps the biggest problems that The Hamburger Report revealed surrounded meat-alternative products. Out of 89 vegetarian samples, 23.6% were found to have issues, from ingredient substitutions to rat DNA to pathogens (see Figure 1). “We were surprised by the higher rate of problems in veggie burgers,” says Mahni Ghorashi, co-founder of Clear Labs. “There were nearly twice as many problems in those samples as their meat counterparts, which is surprising, because you normally think of a veggie product as perhaps a safer bet, but we actually found more cases of pathogen strains. And we found things like beef in veggie products, which isn’t acceptable. That was somewhat troubling.” Ghorashi suggests that manufacturers should be doing more to ensure consistency and adequate labeling of best-handling practices for consumers. “The message is that we need more awareness about the unknown risks and the potential need for more stringent safety measures,” he says. “We follow a great deal of these practices when it comes to meat-based products. Perhaps we’re not as sensitive toward veggie-based products.”

The Hamburger Report, Clear Labs
Figure 1. The Hamburger Report found a higher rate of issues with meat-alternative burger products. (Figure courtesy of Clear Labs)

The report also uncovered several high-risk pathogens in samples, but not the typical ones (i.e., Listeria, Salmonella, E. coli) that make news headlines. Out of the 258 samples, 4.3% contained pathogenic DNA, with vegetable products accounting for four of those instances. Pathogens found included Yersinia pseudotuberculosis, Yersinia enterocolitica, clostridium perfringens, and klebsiella pneumonia. Although these strains are often rare, they still have health implications and can cause tuberculosis-like symptoms, digestive issues and gastroenteritis. Typical methods such as polymerase chain reaction (PCR) are used to detect pathogenic strains such as Listeria, Salmonella and E. coli, but can potentially miss other strains. “The industry should take off their pathogen blinders and start to test for lesser known and potentially dangerous pathogens using these types of blind-testing techniques,” says Ghorashi. “It’s worth casting a wider net and filter in order to catch these [pathogens].”

Although the screening method that Clear Labs used is currently unable to determine whether a pathogen is dead or alive, nor the count, there are other benefits to using next-generation DNA sequencing, says Ghorashi, who thinks the method has the potential to become the technology of choice in the food industry. “The strength of this platform as it differentiates itself from existing solutions is its ability to look unbiasedly and universally into food samples and tell you everything that’s there,” he says. “It’s able to detect any type of DNA-based species within a sample as opposed to specific queries that you might be looking for. This technology can detect everything that’s there, so it often catches things that one might miss. Existing solutions look very focused on one particular item.”

What are the implications of The Hamburger Report in the context of FSMA?

Ghorashi: It’s very much in line with what FDA is rolling out with FSMA. This speaks back to where industry is headed in terms of rolling out more preventive measures versus responsive measures. It plays into economic adulteration and fraud. It also plays into the concept of proactive testing and measures, a better sense of the overall landscape of the supply chain and where the weaknesses are. These are all the areas that software-driven and data-driven platforms can help emphasize. We look at FDA as a forwarding-thinking organization and an ally in this initiative. Hopefully emerging companies, including ourselves, that have new disruptive technologies can help assist the food industry, whether producers, manufacturers, retailers or distributors, in building more air-tight safety programs and complying more closely with FSMA regulations.

Clear Labs is working towards building out its first product, Clear View. The software data analytics platform integrates NGS technology and is designed to aggregate test data in the cloud to provide food manufacturers, suppliers and retailers with insights about their supply chains. The company is also continually growing its internal database, which, according to Ghorashi, is currently the largest molecular food database in the world.

FSMA, Food Safety Tech, FDA

Draft Guidance for Qualified Facilities under FSMA PC Rules Released

By Food Safety Tech Staff
No Comments
FSMA, Food Safety Tech, FDA

Today FDA published a draft guidance to help qualified facilities in complying with the FSMA Preventive Controls (PC) for Human and Animal Food rules. Businesses that are defined as qualified facilities are subject to modified requirements of the PC rules, which can be met by submitting a form to FDA confirming that the site is implementing PCs to address hazards related to its food or is in compliance with non-Federal food safety laws and regulations.

The draft guidance, “Qualified Facility Attestation Using From FDA 3942a (for Human Food) or Form FDA 3942b (for Animal Food)” discusses how to determine whether a business meets the “qualified facility” definition and how to submit the form that demonstrates this status.

The Federal Register is scheduled to publish the document on May 16, at which point the draft guidance will be available for public comment for 180 days.