Imports of food and drug products regulated by the U.S. Food and Drug Administration (FDA) have risen 13 percent since 2011. At the same time, foodborne illness outbreaks linked to imported food also appear to have increased between 2009 and 2010.

With a large number of products traveling through intricate international supply chains, what can FDA and other organizations do to ensure product safety?

Currently, FDA is tasked with overseeing 20 million import lines arriving from 300,000 factories in 150 different countries. The agency’s traditional method of periodically inspecting such facilities to ensure product safety is simply impractical, especially given current budget constraints. The agency needs help from outside sources and other regulatory bodies.

Product safety cannot improve without international cooperation.

That is why the Institute of Medicine (IOM) has released a FDA-commissioned study outlining a strategy aimed at bridging gaps that currently affect food and medical product regulatory systems abroad. The report, “Ensuring Safe Foods and Medical Products through Stronger Regulatory Systems Abroad,” highlights 13 specific actions the federal government can take to strengthen such systems.

From pooling data and planning inspections, to creating partnerships that drive improvements in supply chain management, the IOM suggests FDA use enterprise risk management to guide its efforts in the developing world. This entails aggregating risk information across all products to analyze potential threats to consumer safety.

While there are certainly benefits to globalization, it also poses significant challenges to FDA and its ability to ensure the safety of all imported products. The agency has already responded to such issues by working to increase transparency and accountability throughout the supply chain and enhance collaborations with international regulatory counterparts. It will be interesting to see how the FDA responds to the IOM’s recent recommendations.

What do you think of the IOM’s recommendations? How do you believe the FDA will respond? Your comments are most welcome below.

Stericycle ExpertRECALL™ is the industry leader in recall logistics and regulatory compliance for consumer product, pharmaceutical, medical device, juvenile product, and food and beverage recalls. ExpertRECALL’s professionals are experts in recall management who can help you streamline the entire product recall process.

With 1,200 exhibitors and over 25,000 attendees, the American Meat Institute’s (AMI) 2012 International Meat Poultry and Seafood Industry Convention and Exposition in Dallas, Texas proved to be larger than ever before. This year, the AMI Expo partnered with the Food Marketing Institute’s (FMI) Food Retail Show, United Fresh Produce Association’s United Fresh 2012, and the National Association of State Departments of Agriculture (NASDA)’s U.S. Food Showcase to bring together a diverse group of stakeholders.

From receptions, to meals, to exhibitor-hosted events, the whole industry came together to enjoy all that the AMI Expo had to offer. The two-day event consisted of more than 20 sessions designed to provide attendees real solutions and insight on several topics related to food safety, operation management and consumer trends.

I co-presented a session entitled “Insights from a Recall” with +30 year communications veteran Gene Grabowski, Executive Vice President of Levick Strategic Communications and manager of the firm’s Crisis and Litigation Practice Group.

During our seminar, we provided strategies and solutions for food manufacturers to consider when preparing and executing a recall event. With continued focus on food safety occurring in Washington, effectively managing a recall can make all the difference.

A successful recall response includes both a logistics and communication component.  And establishing a pre-crisis plan can ensure that your company is well prepared for whatever may come. Conducting mock recalls and knowing what information you will need to provide regulators, retailers, and business suppliers will also help recall events run as smoothly and quickly as possible.

Did you attend this year’s AMI International Expo? What sessions did you enjoy the most? How have you prepared your business to respond to a product recall? We welcome your comments below.

Mike Rozembajgier is Vice President of Recalls for Stericycle ExpertRECALL™. Mike is responsible for all aspects of recall service offerings, including development of strategic recall business initiatives, product enhancements, pricing and contracts, and marketing. Rozembajgier has more than 10 years of experience in the healthcare industry. Prior to joining ExpertRECALL he held various management positions at Guidant Corp. (now Boston Scientific) and at Deloitte in the Strategic Consulting practice.

With all the recent stories about fungicide in orange juice, some consumers are wondering why it hasn’t been recalled. The good news is that all the juice that has been tested so far is safe. Even when the fungicide, known as carbendazim, has been detected, it has been at levels far below the safety threshold set by the U.S. Environmental Protection Agency. That’s why none of the orange juice producers have yet needed to implement a recall.

An interesting facet of this story is how the situation came to light. An unnamed juice producer notified the U.S. Food and Drug Administration that there was a low level of carbendazim in its orange juice. That producer reported the finding out of good faith, even though levels detected were well below the EPA’s safety threshold. Then the unexpected happened. The FDA decided to test samples of every imported product, spurring widespread media attention.

We operate today in an ominous regulatory environment. Every agency is under pressure to do more to protect consumers. As a result, the oversight and requirements placed on manufacturers represent an increasingly heavy burden. In these circumstances, manufacturers and producers should continue to do the right thing to inform agencies and protect the public. But companies need to plan ahead now, during times of quiet, to prepare for the recall and media attention that likely follows a good-faith agency report.

Even if these kinds of events don’t always lead to a recall, they often shed light on a company’s recall crisis plan – or lack of one. Have you as a retailer or manufacturer faced an issue that caused you to step back and reassess your recall plan? What kind of plan do you have in place to deal with non-recall food safety issues? Your comments are most welcome.

Stericycle ExpertRECALL™ is the industry leader in recall logistics and regulatory compliance for consumer product, pharmaceutical, medical device, juvenile product, and food and beverage recalls. ExpertRECALL’s professionals are experts in recall management who can help you streamline the entire product recall process.

The E. coli outbreak that struck Europe earlier this year was especially dangerous because it took several days before the source of the contamination was identified. By the time investigators figured out that bean sprouts were the likely cause and started to manage a recall of the product, several dozen people had already died. Looking back at the outbreak, food safety officials around the world are reexamining their procedures, and according to a new report from the European Food Safety Authority (EFSA), producers and manufacturers of sprouted seeds have some work to do to improve the safety of their production chains in order to avoid costly food recalls and ensure the safety of the global food supply.

The EFSA’s report examined risks posed by pathogenic bacteria on sprouts and emphasized the need to prevent contamination from the start. The report examined the unique risks posed by contaminated sprouted seeds in an effort to better understand what caused last spring’s outbreak. It found that a concentration of as little as four percent bacteria per kilogram of seeds can cause a disease outbreak when those seeds are sprouted. Because sprouts are often eaten raw, what might otherwise be a minor contamination poses an especially high risk.

After looking at what happened with those contaminated bean sprouts, the EFSA made several recommendations. The Authority emphasized that it is imperative for producers to ensure that seeds are transported, processed, and stored under proper conditions in order to mitigate contamination risks. Emphasizing this point, an EFSA official made it clear that, “Preventing initial contamination during production, storage and distribution of seeds is of the foremost importance as sprouted seeds have the potential to cause large food-borne outbreaks.”

Additional research shows that the most significant risk factors for bacterial pathogen contamination of sprouted seeds are associated with “contaminated irrigation water and/or manure, presence of birds and rodents in storage facilities, dust and soil particles are potential sources of contamination.” Processing conditions, such as temperature and humidity, during the germination and sprouting of contaminated seeds also pose major risks.

Keeping in mind the special risks associated with storing, transporting and maintaining healthy sprouted seeds, producers around the world would benefit from reviewing the EFSA’s latest assessment of the hazards of seed production, taking special note of how the report’s recommendations can help mitigate safety risks and prevent product recalls.

Producers, distributors and retailers should also take a close look at the training and testing of their recall management teams and retrieval field force so that consumer safety risks can be minimized as soon as a contamination issue is suspected.

Stericycle ExpertRECALL™ is the industry leader in recall logistics and regulatory compliance for consumer product, pharmaceutical, medical device, juvenile product, and food and beverage recalls. ExpertRECALL’s professionals are experts in recall management who can help you streamline the entire product recall process.

After seeing evidence that contaminated pet food may be causing illness among pet owners, the U.S. Food and Drug Administration (FDA) recently announced that it is increasing its efforts to test pet foods for Salmonella. And as the FDA continues to increase its oversight of the pet food industry, pet food retailers and distributors should be aware of how safety concerns facing the industry could directly impact their products. A top priority for the industry at this time is to ensure that effective recall management plans are in place in case it becomes necessary to recall a product.

Because regulators are now concerned that humans who handle contaminated pet food and treats may come down with Salmonella, the FDA plans to conduct a nationwide assessment of pet-related products by collecting and analyzing samples of pet foods, treats, and supplements. In a memorandum published late last month, the FDA explained that it “is particularly concerned about salmonella being transmitted to humans through pet foods, pet treats, and supplements for pets that are intended to be fed to animals in homes, where they are likely to be directly handled or ingested by humans.”

Detailing the procedures of the investigation, a Wall Street Journal article explained that “FDA investigators started taking samples in October of dry pet food, pet treats and diet supplements from distributors, wholesalers and retailers such as PetSmart, PetCo, Wal-Mart, Costco, Sam’s Club and Target.”

With approximately $8 billion worth of dry dog food and $3.7 billion in dry cat food sold in the U.S. last year, manufacturers and retailers should be prepared for the comprehensive campaign the FDA will undoubtedly mount to address consumer concerns about their health, as well as that of their pets.

The FDA memorandum identifies four objectives of the pet food oversight campaign:

• Determine the prevalence of Salmonella in pet foods, pet treats, and supplements for pets;

• Determine the serotype, genetic fingerprint, and antimicrobial susceptibilities of each Salmonella strain found in test samples;

• Ensure Salmonella-contaminated pet foods, pet treats, and supplements for pets are removed from interstate commerce; and,

• Collect investigational samples for research purposes and for providing surveillance information on microbes other than Salmonella in pet foods, pet treats, and supplements for pets.

Now that the FDA has made it clear that it will be stepping up its oversight of the pet food industry, pet food suppliers and distributors would be wise to review their internal procedures and supply chains in order to ensure compliance with the highest safety standards and that they are ready to manage a recall, if that should become necessary.

Stericycle ExpertRECALL™ is the industry leader in recall logistics and regulatory compliance for consumer product, pharmaceutical, medical device, juvenile product, and food and beverage recalls. ExpertRECALL’s professionals are experts in recall management who can help you streamline the entire product recall process.

Cherry Central, a domestic cooperative of several hundred fruit and vegetable growers, recently announced that it will use IBM analytics technology to enhance transparency in its supply chain operations, particularly as goods travel from the farm to supermarkets and consumers. This news is a positive development for all of the cooperative’s affiliated farm growers and shows a genuine commitment to advancing the safety and accountability of their supply chains. Now that their products will be fully traceable, recall management will be much easier and more effective, resulting in a safer food supply.

In a news release, IBM pointed out that highly publicized outbreaks of foodborne illness cost up to $152 billion a year in the U.S., “with 48 million food-related illnesses and 3,000 deaths a year.” The release went on to note that “a breakdown at any point in the food system on the farm-to-table spectrum can cause catastrophic harm to the health of consumers and great disruption and economic loss to the food industry.”

Thanks to the IBM analytics technology, fruit and vegetable growers will have the tools they need to track  produce from when it is harvested, sorted or processed, sent to a distribution warehouse and unloaded at grocery stores or delivered to ingredient buyers. Workers will even be able to upload key data, such as the temperature of the product and the dates and times it is delivered, by using mobile devices, streamlining the process and helping to ensure regulatory compliance and recall effectiveness, should that ever be necessary.

Discussing the new analytical tools, Steve Eiseler, vice president of operations at Cherry Central, said, “This collaboration is helping us create a well-connected and visible food supply chain to make it easier and faster to track the food items we market, while allowing us to spot trends as they’re occurring in real time. This visibility is enabling us to take proactive measures to ensure food safety and ultimately protect the consumer.”

According to IBM, the system also will help the cooperative improve productivity by up to 50 percent.

The use of sophisticated analytics tools is one of best ways to ensure food safety compliance. As previously discussed on ExpertINSIGHTS, projects such as the Produce Traceability Initiative (PTI) seek to achieve exactly the same goals. As technological improvements make oversight of the food supply simpler and safer, initiatives like this will advance public safety and create a new standard for recall management.

Stericycle ExpertRECALL™ is the industry leader in recall logistics and regulatory compliance for consumer product, pharmaceutical, medical device, juvenile product, and food and beverage recalls. ExpertRECALL’s professionals are experts in recall management who can help you streamline the entire product recall process.

The Association of Food and Drug Officials (AFDO), a nonprofit organization that works to streamline government regulation, has received a government grant that will help it to help integrate national food safety networks. Greater coordination between food safety organizations is a crucial development for recall management. By integrating the oversight of domestic food supplies, regulators will be better able to identify the origin of contaminated food, determine the scope of a recall, and help companies and regulatory agencies effectively manage the recall process.

Earlier this month, the Food and Drug Administration (FDA) announced that AFDO would receive $500,000 to promote long-term changes that would enhance collaboration among public agencies responsible for food safety. The grant will give AFDO the opportunity to link different food safety regulation networks, including the FDA and the U.S. Department of Agriculture in order to help reduce the chances that contaminated food will reach the marketplace.

The government has been criticized recently about the divisions among its food control systems.  Critics cite insufficient communication among various federal and state health departments as a primary cause of lapses in oversight that have resulted in foodborne illness outbreaks. Following last year’s passage of the Food Safety Modernization Act, however, the FDA has been given the power to implement new systems that would prevent outbreaks and more effectively investigate those that do occur.

In a statement issued following the announcement of AFDO’s award, the FDA Senior Advisor for Federal-State Regulations said, “A national integrated food safety system will increase the capacity of federal, state and local officials to mitigate the impact of food borne illness, to advance public health and maintain a safe food supply for US consumers.”

According to Food Safety News, AFDO plans to expand its current activities, including maintaining a Directory of State and Local Officials, Registry of Subject Matter Experts, Topical Index of Regulatory Guidance, Program Manager Information Portal and conducting the State Food Safety Resource Survey.

In addition, AFDO plans to will work with FDA to establish a network of manufactured food program managers who supervise the inspection of food manufacturing and distribution facilities, develop and implement pilot projects to support the Manufactured Food Regulatory Program Standards (MFRPS), and develop food safety and defense training programs.

This latest development in food safety oversight is a big step forward for regulators and consumers alike. As agencies are given the resources they need to ensure the safety of our food supply the recall logistics required to remove contaminated food become much easier to manage.

Stericycle ExpertRECALL™ is the industry leader in recall logistics and regulatory compliance for consumer product, pharmaceutical, medical device, juvenile product, and food and beverage recalls. ExpertRECALL’s professionals are experts in recall management who can help you streamline the entire product recall process.

Fears of salmonella contamination have led to a second recall in as many years of soy flour – an ingredient sold on its own and used as an ingredient in many other products.  The processor of the contaminated flour faces another tough test of its recall preparedness and recall management capabilities.  Like the first recall last year, this incident is likely to have a significant impact all along the company’s food processing chain, requiring the removal from shelves of all the various products that used the recalled soy flour. In light of this and a growing number of similar recalls caused by contaminated ingredients, food processors should take the time now to mitigate their recall risk by better managing their supply chain.

This recall again draws attention to the complex task of recall management. When a food producer distributes a product to wholesale customers around the country, “downstream recalls” are inevitable. When a widely used ingredient like soy flour is recalled, many companies and consumer brands are forced to go into recall management mode, immediately removing from shelves products that contain the ingredient.

What can the food industry learn from a consecutive recalls situation like this? It is no secret that the best recall strategy is prevention, mitigating recall risks in the first place by employing the best available manufacturing practices. But when a recall is required, it can be an opportunity for reflection and analysis of your food safety management strategies. You can gain valuable insights, plug previously unknown safety holes, and institute better business practices in the long run.

Companies that supply ingredients for other food processors can learn another lesson from this  soy flour recall. While the FDA press release announcing the recall did not specify the reasons why salmonella contamination was suspected, reports about earlier recalls put a spotlight on the company’s manufacturing procedures and food safety polices.

Companies should be taking all the necessary steps to qualify their suppliers in order to ensure the safety of all the ingredients they buy and use. Doing so will help prevent expensive recalls, limit danger to consumers, as well as damage to the brand and corporate image, regulatory problems, and legal liability. A mismanaged recall can tarnish your brand and reputation and even put the company itself at risk.

It is particularly important for manufacturers that distribute to wholesale customers to ensure that stringent safety and compliance measures are taken at every step in the process and that past incidents of contamination are addressed with increased vigilance and oversight.

Stericycle ExpertRECALL™ is the industry leader in recall logistics and regulatory compliance for consumer product, pharmaceutical, medical device, juvenile product, and food and beverage recalls. ExpertRECALL’s professionals are experts in recall management who can help you streamline the entire product recall process.

In an effort to respond more quickly and effectively to food borne illness outbreaks and food safety issues that may demand recall management, the Food and Drug Administration (FDA) recently announced that it is creating the Coordinated Outbreak Response and Evaluation Network (CORE). Food industry officials should be aware of this new initiative and take steps to create their own programs in order to prevent food safety outbreaks, manage recall risks, and ensure effective recall management.

According to the FDA, the CORE team will be made up of highly regarded scientists and government officials, including epidemiologists, microbiologists, veterinarians, and public health experts with experience containing the spread of foodborne disease.  The team will be headed by Maine epidemiologist Dr. Kathleen F. Gensheimer, formerly of the Harvard University School of Public Health.

The FDA’s efforts are a positive development. In today’s global marketplace, rapid and effective government response to food-related crises is vital. When the crisis involves a foodborne illness that can spread quickly and affect many, it is even more important for the government to have an efficient and reliable system in place to address the problem by taking steps to identify the source, prevent the spread of the illness, and promptly issue the necessary recall announcements.

In the past, the FDA has been criticized for slow and ineffectual response to food-related disease outbreaks. Some have argued for a consolidated food safety agency. But FDA officials are confident that CORE will address these issues by eliminating interdepartmental overlap and lack of communication.  “Basically, the goal is to build upon the best of what we currently do across FDA in incident response,” said FDA spokesperson Douglas Karas in a recent interview with Food Safety News.  It is a point that is made even more relevant by the food recalls that have been issued in the past few weeks, including the ongoing Listeria outbreak in cantaloupe, which has now become the deadliest food borne disease outbreak in more than a decade.

Officials emphasize that prevention will also be part of the CORE mission. In a statement announcing CORE’s launch, Michael Taylor, the Deputy Commissioner of Foods for the FDA, told the press that “the CORE Network builds on the best practices FDA has already implemented in its outbreak response efforts,” adding , “CORE activities will learn from outbreaks to develop preventive systems in an effort to reduce them.”

Stericycle ExpertRECALL™ is the industry leader in recall logistics and regulatory compliance for consumer product, pharmaceutical, medical device, juvenile product, and food and beverage recalls. ExpertRECALL’s professionals are experts in recall management who can help you streamline the entire product recall process.

According to a new government report, federal regulators can do a better job of monitoring how antibiotics are being used by livestock producers. As the FDA and USDA review the findings, all sectors of the food industry should pay close attention to the ongoing debate about antibiotic resistance and be prepared with a comprehensive recall management plan should the need arise.

The Government Accountability Office (GAO) recently released a report titled “Agencies Have Made Limited Progress Addressing Antibiotic Use in Animals” that found that both the U.S. Department of Agriculture (USDA) and the Food and Drug Administration (FDA) are not gathering the comprehensive statistics needed to understand the relationship between antibiotic use in livestock and a possible decrease in the future effectiveness of the drugs for both livestock and humans.

Risks associated with an increase in antibiotic-resistance tied to the widespread use of the drugs in livestock have long worried consumer advocates and regulators. These groups are concerned about the potential for bacteria to develop immunity to critical antibiotics. According to consumer advocates, these strains would also be more likely to pass through inspections and pose health threats to consumers thereby increasing the potential for massive food-related outbreaks and subsequent food recalls.

One such incident should be fresh in the mind of every food industry professionals. This past August, international food producer Cargill issued a recall of 36 million pounds of ground turkey after samples were found to be contaminated with an antibiotic-resistant strain of Salmonella that caused hundreds of illnesses and one death. Within a few weeks, Cargill found itself issuing another recall for 185,000 pounds of turkey after inspectors again found the same strain of salmonella.

According to the GAO report, the FDA collects data on the quantity and types of antibiotics used on livestock, but not on which animals get various types of antibiotics. The USDA monitors data on antibiotic resistance for different animals, but fails to provide a comprehensive nationwide outlook.

The GAO argues that the lack of a comprehensive overview that connects the dots between the different sets of information should be a red flag for the food industry, which cannot rely only on government data to assess risk and avoid recalls.

In a statement following the release of the report, Rep. Louise Slaughter (D-NY), said that the “study reveals how unprepared we are to deal with the growing threat of antibiotic resistant bacteria and the American public should be outraged.” Slaughter went on to reference the recent Cargill recalls, noting that “we have had two massive meat recalls just in the last month showing salmonella strains resistant to antibiotics.”

We expect that regulatory agencies will take the GAO report seriously and we would advise all sectors of the food industry to keep an eye on the continuing debate over antibiotic resistance and how it will influence future policy. It would be wise to be prepared now with a comprehensive recall management plan that takes into account the possibility that a recall driven by antibiotic resistant pathogens may be required in the future.

Stericycle ExpertRECALL™ is the industry leader in recall logistics and regulatory compliance for consumer product, pharmaceutical, medical device, juvenile product, and food and beverage recalls. ExpertRECALL’s professionals are experts in recall management who can help you streamline the entire product recall process.