President Obama recently nominated Democrat Marietta S. Robinson, a Michigan trial attorney with 33 years in practice, to fill a vacancy on the U.S. Consumer Product Safety Commission (CPSC).  If confirmed by the Senate, she will break the bipartisan gridlock following the departure of Democrat Thomas H. Moore in October.

The party split on the panel mirrors the ongoing partisan stalemate in Washington.  Ever since the passage of the 2008 Consumer Product Safety Improvement Act (CPSIA), the CPSC has been challenged by an ideological battle among its commissioners.  The Democrats have accused the Republicans of putting business’s financial interest ahead of consumer safety, and the Republicans have retorted that Democrats are advancing an “agenda” by pushing regulations through without thoroughly weighing the costs with the benefits.  Specifically, the Commission voted along party lines to launch a consumer complaints database, and they also spurred on enacting drop-side crib regulations pursuant to the CPSIA.

Inez Tenenbaum, the Chairman of the CPSC, in a more recent interview said she “bemoaned the bitterness on the board,” which in turn led Republican commissioners to compare the Chairman’s leadership style to that of a dictator.

Should the Senate approve Robinson’s nomination, the Democrats will have the upper-hand, which will likely result in more rigorous enforcement from the agency.  Consumer product manufacturers are well-advised to be prepared for quicker approvals of more stringent safety standards, an increase in regulatory enforcement, and an anticipated release of new federal regulations that will impact a broad array of toys, children’s products, and consumer goods.  Companies should also take extra steps to ensure that they are in regulatory compliance, so as to limit civil or criminal litigation and regulatory fines.

Meanwhile, what are your thoughts?  How will the Senate respond to President Obama’s nomination of Robinson?  If the nomination is approved, how will it impact your business?  Do you think it will result in more scrutiny of the consumer products industry and lead to additional stories of large civil penalty settlements and seized imported consumer products? Please feel free to share your comments below.

Thomas M. Barba is an experienced products liability litigator and advisor who is a partner in the Washington office of Steptoe & Johnson LLP. You may contact him at (202) 429-8127 or tbarba@steptoe.com. 

It’s been more than a year since the Food Safety Modernization Act (FSMA) became law, and the U.S. Food and Drug Administration has fallen behind on some important deadlines Congress included in the legislation.

By January 4, the agency was to have initiated the rule-making process for produce safety standards and completed rules for the new foreign supplier verification program. There is no word from FDA on when those rules will be implemented. Under the law, the FDA was also ordered within a year to have published guidance for schools and childcare programs on allergy risks – a step that determines what products falls into the “high-risk foods” category facing stricter record-keeping requirements. By this time it was also supposed to have established five Integrated Food Safety Centers of Excellence at state health departments.

Over the next three years, the law directs the FDA to implement more than 50 new rules, regulations, and programs designed to improve food safety. FDA spokespeople tell us broadly that it will be physically impossible to make good on all of those deadlines but that they are busy prioritizing the tasks. Most consumer and health groups are exercising patience with the delays, pointing out that the FDA has met a number of other deadlines, including the completion of 600 facility inspections in 2011 and revamping its recall website to make it more consumer-friendly.

Food processors, retailers and all of the other links in the chain from farm to table should take no comfort in the delays inherent in FDA rulemaking. Instead, they should be aggressively upgrading their own food-safety systems, recall plans and other related programs on an ongoing basis. Regardless of what is or isn’t happening currently at the federal level, the movement toward a food safety system that is preventative, scientifically based, traceable and global in scope continues to accelerate. It may take a bit of extra time to get all of the government architecture in place, but that day will arrive soon enough and, before it does, expectations within the trade and the general public, not to mention the behavior of the courts as driven by the plaintiff’s bar, will continue to create new opportunities for those who can adjust and serious problems for those who cannot.

What are your thoughts about the FSMA? Is your company prepared for it? Do you consider it a hindrance to your business or an essential way to protect consumers? Please feel free to present your comments below.

Robert G. Hibbert’s practice focuses upon federal regulation of the food and agricultural industries. Areas of particular concern include food safety, food security, animal health, biotechnology, labeling, advertising, and new product development. You may contact him at 202-778-9315, or robert.hibbert@klgates.com.

There’s been a lot of commentary online of late from both sides of the most current food safety regulatory debate. Should we keep the current structure for food safety functions, or merge the U.S. Food and Drug Administration (FDA) and the U.S. Department of Agriculture’s Food Safety and Inspection Service into one regulatory body?

The Obama administration showed its hand in a recent Hagstrom Report newsletter that noted the president is considering merging food safety responsibilities under a single agency. But this is a warmed-over concept. Nearly a year ago, the Government Accountability Office released a report recommending the same structure. And consumer advocates have been recommending it for decades. Under this arrangement, all processed and packaged goods, produce, meat, dairy and produce would be regulated by the same agency.

This seems on its surface to be an easy solution to simplify the current regulatory environment for the food industry, which can be quite complex and confusing to navigate. But it’s not as easy as it sounds. What Congressional committee chairmen will want to relinquish their fragmented oversight authority? Then there’s the heartburn such an arrangement will create among manufacturers and retailers who will be forced to adjust to a new and likely more rigid regulatory environment.

Food Safety News has also published commentary on the theory of a single regulatory agency by Dr. Richard Raymond, the former Undersecretary for Food Safety for the U.S. Department of Agriculture. He takes a dim view of the idea.

What are your thoughts on the issue of regulating the food industry to ensure food safety? As business executives, managers and lawyers, what about the notion of a single food safety agency makes you nervous? Conversely, what opportunities do you think it creates for you? 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.

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.

Foodborne illness cost the U.S. economy up to $77.7 billion in healthcare costs annually, according to a new study in the Journal of Food Protection. The latest estimates, which do not account for the costs associated with product recall management and other relevant economic impacts, hint at just how taxing contaminated foods can be to the overall economy. The news is an important reminder to manufacturers and distributors of food supplies of how critical it is to be prepared with comprehensive recall management plans. The longer contaminated goods are available in the marketplace, the greater the overall costs, not only to the U.S. economy, but to manufacturers and retailers.

The study, conducted by Robert Scharff, a consumer science professor at The Ohio State University, updates previous estimates that pegged related healthcare costs at $153 billion. Scharff, who calculated the original and frequently cited estimate, reworked his study after the Centers for Disease Control and Prevention (CDC) released new data finding that 48 million people fall ill each year from foodborne illness. The CDC had previously estimated that number to be as high as 76 million.

Bacterial contamination and subsequent recall logistics pose major risks for the food industry. Despite being significantly lower than previous estimates, the $77.7 billion mark does not factor in a host of economic impacts that would dramatically increase the economic burden caused by the onset of foodborne illness. A recent Food Safety News report details the parameters of Scharff’s study, which includes economic estimates for medical costs, productivity losses and illness-related death.

The study does not factor in costs that food contamination and recall processes incur on the food industry. This includes not only potential recall losses and litigation, but reduced consumer confidence and trust in the marketplace. Additionally, the study fails to incorporate the costs to local, state and federal public health agencies that are tasked with responding to outbreaks of foodborne illness.

Using the latest estimates, reducing foodborne illness by just one percent would prevent some 500,000 people from getting sick each year, while reducing that number by 10 percent would prevent up to 5 million people from becoming ill. Recall logistics and recall management play a vital role in this process and could mean not only saving billions of dollars in economic costs, but preventing serious illnesses and even deaths.

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 Obama Administration recently released a report on the progress of its Food Safety Working Group (FSWG), detailing areas where organizational improvements can still be made to improve food safety and discussing the vital role that recall management plays in ensuring consumer safety. In addition to stressing the need for improved preventative measures to mitigate the onset of foodborne illnesses, the FSWG report discusses the importance of recall management and recall processes.

The FSWG, launched soon after the salmonella peanut butter outbreak in early 2009, works as a central coordinating mechanism for the federal government’s food safety initiatives. The Group is led by the Department of Health and Human Services and the Department of Agriculture.

According the report, the “highly complex and decentralized nature of the food supply system” makes it “inevitable” that foodborne illness will occur and “impossible to eradicate completely.” Importantly, the report recognizes the need for efficient and effective recall management in order to meet the “inevitable” lapses in consumer safety posed by food contamination risks.

Advances made and highlighted in the report since FSWG was launched include a mobile recall application that allows consumers instant access to information on food recalls, alerts, and the ability to actually view pictures of product labels for goods that have been recalled or are on recall alert. The application can be accessed at www.USA.gov.

The FSWG has also worked this year to improve public communications by updating and enhancing the food safety website, www.FoodSafety.gov. The site, which is a collaboration of the Centers for Disease Control, the Food and Drug Administration and the Food Safety and Inspection Service, provides the latest updates on food recalls, food safety alert subscriptions, important information on emergency preparedness, and tips for food safety preventative measures.

These advances undoubtedly help improve the safety of our food supply, but the steps taken by the FSWG and companies to protect consumer safety are no silver bullet to eliminate recalls. These latest updates and enhancements to food safety communications will certainly play a critical part going forward in modernizing our food safety system. But as the federal government works to improve public safety standards, recall management will continue to play a decisive role in ensuring contaminated goods are not available on the marketplace.

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.

A recent string of recalls in Canada serves as a reminder of not only how one or two recalls can plague an entire industry, but also that retailers carry a significant burden of responsibility for the products they sell. As if this weren’t enough, these events also shed light on what can happen if and when there is miscommunication between manufacturers, suppliers, and retailers. These three issues should be top of mind for companies at all times when reviewing their recall preparedness and recall prevention methods, not to mention when their team is faced with managing a recall and the communications challenges that go along with it.

Thus far, more than a dozen companies, including retailers, have been pulled into this flurry of recalls by Health Canada, which happens to coincide with the holiday season and thus presents yet another series of challenges for companies facing these regulatory actions.

According to a Postmedia article published in the Montreal Gazette, one retailer is arguing that Health Canada is being harder on retailers than on the manufacturers when testing for lead and cadmium. The retailer explains that its manufacturers deliver with its products lab reports indicating the safety of products, including lead content. But whether or not there is a double standard is only one of the challenges retailers could face, at least in the U.S. where retailers face increased liability under the Consumer Product Safety Improvement Act (CPSIA).

The story line has similarities with last year’s string of cadmium recalls in the United States triggered by an Associated Press investigation into consumer products, which triggered further regulatory action after the recalls were closed.

While the U.S. Consumer Product Safety Commission (CPSC) is working with the consumer products industry to write regulations limiting cadmium content, and several states have instituted bans on cadmium, Health Canada has not taken any steps to regulate the chemical to date. But much like one string of recalls sparked these regulatory developments in the United States, Canadian manufacturers and retailers can expect the same consequence from this recent series of product recalls.

As new regulations contribute to a patchwork of consumer protection laws regulating the use of cadmium, manufacturers and retailers should keep an eye on pending legislation at both the state and federal level, and seek to mitigate the dangers of cadmium contamination before being forced to do so by the regulators.

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.

Recall communication can be difficult on any given day. Breaking through the clutter of media attention and daily news stories to reach businesses and consumers with information about a recall is often a real challenge. But that challenge is amplified significantly during the holiday season. Manufacturers and retailers should be aware of the issues that could cause them trouble and ensure that their recall management system is prepared for the most difficult of recall situations.

Increased sales of toys and other children’s product during the holiday season demands that manufacturers, distributors, and retailers take increased responsibility to watch for product risks and maintain strict safety standards. It also means more people to communicate with during the recall.

I recently wrote an article for Christian Science Monitor that provided several ways that consumers can help ensure that their children’s gifts are safe, including:

1. Signing up for recall alerts and safety advisories.
2. Filling out product registration cards.
3. Downloading product-recall mobile phone apps.
4. Saving and following product assembly instructions.
5. Being extra cautious when shopping at consignment shops or secondary stores.

But when it comes down to it, manufacturers and retailers are the ones left holding the bill during a product recall. It is the responsibility of companies to communicate with customers and consumers about recalls, or risk fines and penalties from federal regulators.

Retailers and manufacturers must understand that they, along with the government, are in the consumer safety business. By embracing this shared goal, companies can more effectively manage recalls and yield positive result, even during the recall crisis.

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.

We’ve talked several times before about the challenges that companies could face when Congress and trade groups focus their eyes on chemicals and ingredients commonly used in the manufacturing and production process across industries. The chemical currently in the spotlight of these groups is bisphenol A, or BPA. As the U.S. Food and Drug Administration (FDA) considers whether to ban the use of the chemical, manufacturers should be searching for a potential replacement and testing their recall management plans to ensure that, should a recall be necessary, the team knows exactly which products contain BPA and from where they need to retrieve them.

BPA, a chemical commonly found in food packaging and on paper receipts, is currently under fire by environmental and consumer safety groups including the National Resources Defense Council. In fact, the FDA is considering the ban as part of an agreement with the National Resources Defense Council which was approved by U.S. District Judge Barbara S. Jones in New York on December 7.  Under the terms of the agreement, the FDA must issue a final decision on the BPA ban before March 31, 2012. The ban, should it go into effect, would prohibit the use of the chemical in food packaging.

BPA made headlines earlier this year after a study confirmed that it can leak into food products and can be easily transferred to the skin. BPA exposure has been linked to several health risks, including several types of cancer.

In one recent study, cited in a recent Pittsburgh Post-Gazette article, the Harvard School of Public Health linked consumption of canned soup to elevated BPA levels. The study’s lead author, Jenny Carwile, explained the shock of the finding, telling the paper, “It was very surprising because we gave them so little canned food.”

However, industry trade groups including the American Chemical Council and Grocery Manufacturers Association explain that regulatory authorities around the world have found that BPA is safe for use in food containers. But while many companies are only now advocating the removal of BPA from manufactured products, it might have been helpful to have had in place tougher testing and oversight so that BPA could have been regulated as soon as it went on the market.

We applaud the many manufacturers that are phasing the chemical out of the production of products, including plastic baby bottles and water bottles. But at the moment, food manufacturers are at the center of the current debate. These companies should take the time now to prepare their recall management teams should their action need to be immediate in response to the potential ban on the chemical.

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.

It should come as no surprise when major industry-wide product recalls lead to new federal standards or safety rules. In one recent example, the U.S. Consumer Product Safety Commission (CPSC) voted in favor of publishing an advance notice of proposed rulemaking (ANPR) aimed at improving the safety of recently recalled gel fuels and firepots. As the agency fields public comments over the next two months about the proposed rules for these items, manufacturers should conduct their own audits as a final step in their recall management efforts in order to ensure that they are prepared to comply with new rules that could govern the industry in the coming months.

By identifying such concerns early on, manufacturers of related products will be better prepared to implement the new federal standards. Once standards are finalized, it’s imperative that manufacturers are ready to update their product lines accordingly, in an effort to avoid any costly future recalls.

According to an article in Consumer Reports, the CPSC launched an investigation into firepot burn accidents this past June, resulting in multiple recalls by a variety of manufacturers. The article notes that, “publishing the proposed rules alerts the industry to the possibility of federal standards being introduced for the labeling or performance of a product, or a ban if no adequate standard can be found.” Importantly, this process also allows manufacturers the opportunity to present evidence showing they can set up their own effective industry standards.

The ANPR also offers the general public the opportunity to submit written comments. The public has 60 days from the publication date to submit comments to www.regulations.gov.

As always, staying advised of the latest ANPR’s from the CPSC will allow manufacturers and retailers insight into the development of new rules governing consumer product safety. As the CPSC works to create comprehensive rules that address these latest safety concerns, manufacturers and distributors should be ready to update their product lines or else face potential product recalls.

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.