On Friday FDA released its 2015 Annual Report to Congress on the Use of Mandatory Recall Authority and there was not much news to report. According to the agency: “In FY 2015, FDA had no mandatory recall activity to report under section 423 of the FD&C Act. As a result, FDA did not issue any public health advisories as described in section 206(f) of FSMA.”
This is the third report of its kind since FSMA was enacted. It is worthy to not that it only deals with recalls themselves, not other agency communication efforts such as public health advisories, which include consumer advisories, warning letters and reports of outbreak investigations.
After uncovering foreign material in an incoming ingredient during the production process, Huisken Meat Company has recalled 89,568 pounds of beef patties. According to the USDA, the recall is due to concern that the products may be contaminated with “extraneous wood materials”. The Sam’s Choice Black Angus Vidalia Onion patties come in 2-lb boxes and were shipped to retailers across the country, including Walmart.
There have been no reports of adverse reactions, and the USDA is advising that consumers throw out the items or return them to the retailer.
As a result of the finalization of FSMA regulations on September 10, 2015, increasing requirements for procedures, documentation and testing will soon be impacting the food industry. The major effects on the food microbiology testing market will come in the form of an increase in the volume of samples that must be processed in accordance with the new FSMA rules, along with an improved emphasis on accurate and complete record keeping. The goals of FSMA are to create a new safety standard across the entire food chain. Increasing food pathogen testing will minimize possible recalls and the probability that dangerous food outbreaks occur.
Food manufacturers’ testing labs and third-party accredited testing labs can meet the demand for increased testing and improved record keeping in one of two ways: Via facility expansion or via implementing new technologies into the laboratory. While facility expansion might be an ideal long-term solution, it will not address the immediate surge in lab demand brought on by the new FSMA requirements, as it takes time to build new laboratories and hire employees. Implementing new technologies in the lab, then, makes the most sense, and where automation can be introduced into traditionally-manual processes, higher throughput may be realized using existing personnel and facilities. Automation further removes human error and improves the quality of the test being performed. The challenge for lab managers will be to objectively look at the current production bottlenecks in their testing operations and determine where technology may be introduced to increase throughput.
In addition to mandating additional testing, the FSMA regulations will require improved lab record keeping, as well as a new accreditation process that FDA will implement. The food testing industry faces the same dilemma that the healthcare industry faced some years ago in migrating from manual files to electronic health records. Lab notebooks have a real purpose in the lab, but their purpose should be more as a backup system to information that is gathered and stored electronically. While Laboratory Information Management Systems (LIMS) have been around for many years, their full potential in pathogen testing has yet to be realized. A properly designed LIMS provides an electronic database that not only aids in the accreditation process, but also allows samples to be traced throughout the testing facility. This allows positive test results to be screened from false positives or false negatives, and points to which equipment or procedures in the testing process need to be improved upon. LIMS technology for recording digital information can also trace user, operation time and performance specifications more accurately than lab notebook-based processes.
In summary, many changes are coming to the food industry as a result of increased regulations, presenting exciting opportunities to develop new products and technologies to alleviate the pain points within testing labs. The industry of food pathogen testing must change alongside the regulatory atmosphere in order to be competitive in a post-FSMA era.
In a recent survey of food and beverage executives, nearly half of respondents named product quality as a major risk area and cited product recall capabilities as a priority. However, only about one-third of executives expressed confidence in their companies’ current safety and recall strategies.
“Mitigating [product] risks starts with tone at the top and leadership within a company,” says Cristin Singer, assurance partner with McGladrey, LLP. “Companies have a strong focus on the diligence associated with quality (especially among employees involved in testing) and building long-standing, trusted relationships with suppliers and vendors.” Many companies are also increasing their testing of imported products and making sure that their partners are familiar with the cultures of the regions from which they import goods as part of their risk mitigation strategy.
The Food and Beverage Industry survey, conducted by McGladrey, involved 179 executives, owners, and decision makers from food and beverage companies with annual revenues between $10 million and $1 billion.
Product Recalls. Some companies are basing their product recall strategy on where they actually fall within the supply chain. “I’ve found that when a company feels that they serve as a middle-man distributor, and depending on the contractual relationship with the co-packer, they look to the processor or co-packer to manage the recall process,” says Singer, who is also a member of McGladrey’s national consumer products team. In addition, Singer sees a focus on due diligence related to co-packers and suppliers to ensure they have proper certification, and processes and procedures in place to manage risks and recalls.
Wage and Labor. Food and beverage companies are also facing a variety of wage and labor issues. Larger companies expressed concern with increased labor costs and attracting technical talent; smaller companies are more worried about minimum wage legislation labor costs, and retaining skilled labor workers on the shop floor. Executives also cited that minimum wage legislation and the Affordable Care Act could pose challenges over the next year.
Data Security. As more companies adopt platforms that store sensitive data, the security of these systems is important. Yet only about 42% of executives are very confident that their data and systems are secure from authorized access (about 50% are “somewhat confident”). Improving employee security protocols and providing training, involving data security consultants, and conducting due diligence on vendor data security are among the actions that companies are taking to enhance the security of their platforms. “If there’s a data breach, a lot of sensitive information could be put out there, including product formulations, intellectual property, and employee data (social security numbers or healthcare data),” says Singer. “Initially a lot of companies on the retail side were focusing on data security. Now we’re educating our clients, especially those on the distribution, processing or manufacturing side. All levels of the supply chain are at risk.”
Whole Foods Market voluntarily recalls packaged raw macadamia nuts due to possible Salmonella contamination. Recalled items were sold in AR, AZ, CA, CO, HI, KS, LA, NM, NV, OK, TX, and UT Whole Foods Market Stores. No illnesses have been reported to-date. Based upon routine testing conducted by an FDA-contracted laboratory, it was determined that the raw macadamia nuts tested positive for Salmonella.
Beech-Nut Nutrition recalls approximately 1,920 pounds of baby food products that may be contaminated with small pieces of glass… The baby food product was produced on December 12, 2014: 4-oz. glass jars containing “Stage 2 Beech-Nut CLASSICS sweet potato & chicken. The problem was discovered after the firm received a complaint from a consumer who found a small piece of glass in the product. The company has received a report of an oral injury associated with consumption of these products. FSIS has received no additional reports of injury or illness from consumption of these products.
Beech-Nut responds: “At Beech-Nut, we strive to make baby food with the best ingredients nature has to offer – freshly prepared and packaged in clean, safe and environmentally-friendly packaging. So, when any product of ours falls short of those standards, we take swift action to correct it.”
The cured and uncured pork items were produced on various dates between August 7, 2014 and April 1, 2015… The problem was discovered when an FSIS inspector was conducting a Food Safety Assessment and observed a processing deviation.
In the fourth quarter of 2014, undeclared allergens accounted for 50 percent of all FDA food-related recalled units and 83 percent of USDA recalled units.
In the past few months, retailers pulled hundreds of products from shelves after a spice supplier found traces of peanut proteins in their cumin spice – an ingredient that dozens of manufacturers use in products across the country.
Ramifications from the recall, which began in December, still occur daily; over two months after the spice supplier first identified the issue. To some the recall may seem miniscule, however, to the nearly 15 million Americans the CDC says has food allergies, undeclared allergens can be a life-threatening scare.
Despite increasing regulations and industry scrutiny, undeclared allergens continue to serve as a primary cause of food recalls in the U.S. According to the latest Stericycle Recall Index, in the fourth quarter of 2014, undeclared allergens accounted for 50 percent of all FDA food-related recalled units and 83 percent of USDA recalled units.
According to FDA, the most common foods involved in food allergen recalls are bakery products, snack foods, candy, dairy products and dressings. The FDA also identifies the most common allergens causing the recalls as milk, wheat and soy.
Undeclared allergen recalls are often a result of a simple manufacturing operational error, such as mislabeling, mis-packaging or unintentional cross-contamination. In the U.S., manufacturers of FDA regulated foods are required to identify major food allergens on the label; if mistakes occur in manufacturing, companies may be subject to a product recall.
As recent recalls show, the more complex the supply chain, the more complex product recalls become. Globalization of the supply chain also complicates recalls, especially when regulatory agencies from multiple countries have different recall mandates. The Stericycle Recall Index highlights some of these unique challenges in the global supply chain, including accessibility to remote areas.
Companies with proactive recall strategies in place can navigate their supply chain with ease when a supplier or an undeclared allergen issue arises. Having these processes identified prior to an event can save valuable time, money and help a company maintain regulatory compliance, while also concentrating on future growth.
While there are many tools available to help food and beverage companies manage their supply chain, the integration of electronic systems in ensuring effective connectivity can be a challenge. During a Food Safety Tech conference, a panel of industry experts shared their perspectives on how to use tools to manage and communicate recalls, and the importance of focusing on a food safety management system. Melanie Neumann, executive vice president and chief financial officer of The Acheson Group, cited recall communication programs such as Rapid Recall Exchange and Recall Info Link. “They’re great programs in that they The 2015 Food Safety Consortium Conference (November 17-20, 2015 in Schaumburg, IL) features topics on supply chain risk and vulnerabilities. Register now. communicate outbound, downstream to the recipients of recalled products. It gets [product] out of the hands of potential consumer purchasers and consumer consumption,” said Neumann. “Here’s what it doesn’t do: They have no way of knowing whether or not they’re communicating out all of the affected product. It still comes back to industry’s responsibility in effective supply chain management to know you’ve captured all of the affected recalled product that those systems are then used to communicate outbound.”
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