The budget increase will go to support programs that are necessary to preserve the safety of medical products and meet the FDA’s growing duties. However, recognizing the need for fiscal constraint, the budget also includes spending cuts in several areas. The Commissioner of Food and Drugs, Margaret Hamburg, M.D., explains, “Our increases are targeted to strategic areas that will benefit patients and consumers and overall strengthen our economy.”

Many of the user fees will support enforcement of the 2011 Food Safety Modernization Act. It is estimated that programs under the FSMA will cost $295 million next year, 85 percent of which will be funded by user fees. According to The Hill’s Regulation blog, the FDA asserts, “these investments will provide industry with consistent and transparent food and feed safety guidance to assure the safety of America’s food and feed supply.” With 48 million cases of food-borne illness each year, which lead to 128,000 hospitalizations and 3,000 deaths, at a total estimated cost of more than $78 billion, food safety must continue to be a priority. Effective food safety measures enacted by the FSMA, in congruence with food manufacturer compliance, can help prevent food contamination and food recalls. These prevention tactics not only protect consumers, but they also save money and protect the brand reputation of food manufacturers.

The new fees will support safety programs for food imports as well as food facility registration and inspection among others. The FDA anticipates that these fees will generate approximately $269 million.

In addition to increased domestic food facility inspections, there is also a need for user fees to support hiring more inspectors in China so that additional on-the-ground food facility inspections can occur. The increased inspections reflect the FDA’s continued shift to prevention tactics as opposed to outbreak response.

What would be your advice to food manufacturers as the FDA increases its enforcement of the Food Safety Modernization Act? We welcome your comments below.

Planning for a recall requires companies to work through several steps before a recall is a reality. Some recommendations that Holly outlined are:

• Conduct mock recalls
• Develop a recall checklist
• Incorporate supply chain partners into recall plan

During the recall, it is critical for a company to display a key leadership role in efforts to protect the public. Additionally, a disciplined and effective recall plan will ensure that the recall is closed quickly, allowing the company to focus on its brand-building strategies.

However, one key takeaway from the discussion concluded that for a company or brand to be bulletproof, it takes more than planning for a potential recall situation. Protecting a brand reputation is crucial and can be achieved with an effective communications plan.However, communicating the safety of an individual product is not enough to ensure consumer trust and confidence in the overall brand. A communications strategy must target all invested stakeholders, including customers, suppliers, retailers and government regulators.

The secret to initiating a robust communications plan starts with first listening to the current conversation and recognizing where your audience lies. The Bazaarvoice Conversation Index analyzes more than six million pieces of user-generated content shows that three out of four posts contain potentially actionable product improvement insights. This research also showcased the current concerns of American consumers. In a span of five year, 65 percent more Americans are concerned about food safety and 92 percent view food recalls being as important as saving lives. The significance of product safety and information goes beyond sales now; consumers’ loyalty is reciprocal to your brand’s loyalty to the customers’ needs.

Building out a targeted communication strategy that addresses the concerns of all stakeholders is a critical step in ensuring that a brand is protected during and following a recall event. Additionally, measuring the effectiveness of these communication efforts can highlight a company’s commitment to due diligence. Notification tactics and response rates are evidence to support agency compliance efforts and can also shape the public’s perception of a company.

What tools do you think companies should be using to address consumer complaints? We welcome your ideas and comments.

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 USDA food recall data indicates that undeclared allergens are the second most frequent cause of USDA recalls, totaling five product recalls this quarter. Additionally, foodborne pathogens continue to pose a serious threat to food safety. When combined, salmonella, E.coli, and listeria are the primary causes of nine recalls this quarter, up from five recalls last quarter. Steps to reduce the risk of food contamination – whether due to extraneous materials or foodborne pathogens – are imperative. Preventative tactics are key for ensuring food safety and maintaining brand reputation.

Nearly three out of four FDA-announced food recalls announced in the first quarter were issued by companies facing two or more recalls within the 90-day period. This can tax the resources of food companies to successfully navigate logistical challenges and regulatory complexities of recalls. Rozembajgier clarifies that this is not unusual for companies to face, as ingredients are generally used in more than one product. He notes that, “The ongoing trend of multiple product recalls can complicate the logistics of a recall, and make it harder for companies to communicate to consumers and protect their brands.” This also highlights how important preventive tactics are today for your brand’s protection. Companies need to know their supply chain’s safety standards and focus on a high level of standard qualities across the levels of the supply chain. Conversely, companies also must uphold standards of safety themselves before implementing or encouraging standards on their suppliers or manufacturers.

With increased media and government scrutiny on safety standards within the food industry, reports such as the Quarterly Index provide companies with key insights as to recall trends across various agencies and industries.

Read the full ExpertRECALL Quarterly Index here.

Listen to Mike Rozembajgier, VP of Recalls, discuss the Quarterly Index:

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 The Hill, this issue has started to gain traction on Capitol Hill as the political arm of Consumer Report magazine has pushed for legislators to reign in use of antibiotics in healthy animals. However, the National Cattleman’s Beef Association states that:

“Antimicrobial resistance worldwide is a concern for producers, researchers and the veterinary and medical community. A tremendous amount of international research has been done on the topic and to date there is ZERO scientific evidence that use of antimicrobials in livestock causes antimicrobial resistance (AMR) in humans.”

Sources from the International Food Information Council and the U.S. Farmers and Ranchers Alliance criticized the EWG report, “Superbugs Invade American Supermarkets” as misleading. Likewise, Randall Singer, a professor of veterinary science noted, “the number one misunderstanding about antibiotics in animal agriculture is that it is not understood well enough that antibiotics are used to keep animals healthy, period.” The EWG report overlooks important data and facts about food safety and wrongly blames antibiotic use in food agriculture for the presence of antibiotic resistance bacteria. Professor Singer explains that finding resistance to antibiotics in humans isn’t necessarily caused by the use of antibiotics in animals. Despite being used to promote growth and reduce costs of food animals, antibiotics in meats are a growing concern for the public and have resulted in recent increased sales of antibiotic-free meat.

A recent Ag Web release addresses this misconception and clarifies that food producers take antibiotics use seriously, with farmers working closely with veterinarians to treat and prevent disease. To this point, Dr. Keith Belk, a professor in red meat safety at Colorado State University’s Department of Animal Sciences, said antibiotics are heavily regulated. In the realm of food safety and company’s food animal agriculture, it is worth citing reliable and robust research in assembling the best food safety program. The best way to ensure your food safety practices are fully updated is to continually review and reference the latest reports and ensure programs are at a minimum meeting the FSMA’s mandated standards.

What would you say to legislators on the issue of antibiotic use in animals? We welcome your thoughts 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.

Corporate sustainability refers not only to environmentally sound practices, but also to practices that support the overall longevity of a business. Supply chain management is a specific area of business operations where companies are seeking out strategies to mitigate and limit risk. Sustainable Plant recently highlighted the correlation between supply chain sustainability and risk management, suggesting that companies that don’t pursue sustainable supply chain management practices are risking their long-term viability. A recent article on Chiquita Brands in Food Safety Magazine highlights how Chiquita is mitigating risk by implementing sustainable practices, particularly through its supply chain management.

Food safety in the produce industry requires ongoing management to identify and minimize potential risks in the supply chain. For fresh produce companies such as Chiquita, sustainable supply chain management practices must begin before seeds are even planted and follow through to the distribution of all the various produce products. Chiquita Brands not only meets regulatory requirements in its countries of operation when it comes to its food safety, but it also goes above and beyond to implement best practices across all regions regardless of minimum requirements. While it forces Chiquita to invest more resources, this practice allows the company to more effectively monitor for pathogens and other harmful contaminants.

According to a recent PwC study cited in the Sustainable Plant post, sustainable supply chain management must include a few key steps such as establishing standards for suppliers. Recognizing the importance of safety at every level of the supply chain, Chiquita addresses global food safety through its Chiquita/Fresh Express GAPs Manual, which provides an overview of all company standards including resource management.

A company cannot hold its suppliers to standards it does not uphold itself; PwC emphasizes that the biggest challenges companies face in encouraging sustainability from their suppliers is maintaining a visibly equal effort in their own practices. Chiquita believes in the strictest food safety practices and these standards act as a guiding force in the fresh foods industry. Chiquita also shows its commitment to food safety by close collaborating with regulatory agencies to share research, knowledge and best practices to mitigate the development of new risks to food safety. By taking a global approach to its supply chain and going above and beyond minimum safety requirements, Chiquita has built a sustainable supply chain management system that acts as a driving force in its long-term success as a company.

How are you modifying supply chain management practices to enhance their sustainability? We welcome your thoughts and comments.

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.

I recently visited several farms and saw some examples of how these farms are adapting to the new FSMA regulations, including:

• Ensuring that their recall plan is active and in place
• Testing their recall plan and meeting yearly with their team to discuss mock recalls
• More stringent supplier agreements to ensure appropriate plans are in place from suppliers that handle their finished good products
• Monitoring their supply chain partners to ensure safe handling of product
• Testing products and sample retention along with smaller batch/date code sizes

In a series of recent blog posts entitled Harvesting Justice, The Huffington Post reported on Blue Hill, a small farming town in Maine, whose farmers have recently been taking “bold steps” to protect their local food system. Their argument, as presented in the blog post, notes that small-scale farming doesn’t spark the same safety risks in food production as those analyzed for national food-safety regulations. Small farmers argue that the personal nature of their business, where they sell to and interact regularly with people who eat their food, creates a built-in safety protection and that makes federally regulated inspections unnecessary.

It is understandable that the costs associated with meeting the FSMA regulatory standards could have a greater affect on small farms than industrial farms, but food safety standards must remain constant for consumers, regardless of whether food is sourced from a small or large farm. FSMA aims to ensure that the U.S. food supply is safe by shifting focus from responding to contamination to preventing it. In a continued effort to contain contamination and standardize prevention, FSMA must be adhered to by all sources of food supply in the United States, including small-scale farms.

How have you seen both large and small food manufacturers adapt to the new FSMA regulations? We welcome your thoughts, opinions, and questions 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.

Those days are long gone. Health Canada is busily implementing (and expecting you to comply with) its own product safety legislation, and the Electrical Safety Authority (“ESA”) in Ontario has parallel authority and expectations. What you tell one agency may, or may not, be passed along to the other. Each has their own electronic form they want you to submit, and their notice and recall thresholds are similar (but not identical), not only to each other but to the CPSC’s requirements. Just like the CPSC, however, each of the Canadian agencies has idealistic expectations of immediate awareness, analysis, and reporting. The saving grace is the lack of interest, for the moment, of assessing significant penalties for “late” reports. And there are recent reports from both Health Canada and ESA of their willingness to consider changes in their processes that could reduce the burden of redundant reporting.

The European Union is changing its rules as well, although they plan to implement them no earlier than 2015. But the proposed changes are significant, and to comply you will need to start acting now. For example, products will need a “risk assessment” that can be disclosed to the regulatory authority upon request. As we all know, risk assessments are living documents that originate in initial product design and mature over the life of the product. How would you like your “risk analyses” to be disclosed to the EU regulator? Now is the time to revise your FMEA and product safety processes to generate useful, but not alarmist, risk analyses. In addition, the new EU rules will require that you track your suppliers of materials and components, and keep those records for ten years. Finally, the new rules will be implemented and enforced by the central safety bureaucracy, not by each individual country, and the existing RAPEX data system will be beefed up to ensure that all countries know about recalls in all other countries.

Are you ready for all of this?

Lee L. Bishop serves as Counsel at Miles & Stockbridge P.C. and advises businesses on a full range of consumer and industrial product issues with particular emphasis on product risk management, product recalls, warnings, product safety and liability issues, quality and regulatory compliance. Mr. Bishop regularly speaks on product safety management issues before national organizations, such as the Defense Research Institute, ALFA International, American Bar Association, Consumer Product Safety Commission, and the International Consumer Product Health & Safety Organization. You can find further insights from Mr. Bishop at ProductSafetyBlog.com.

• Salmonella: Salmonella bacteria can be found in raw or undercooked eggs, poultry, or meat. During food production, produce and ready-to-eat food products must be kept separate from potential sources of Salmonella contamination. Additionally, any tools used to handle raw poultry or meat must be kept separate from other food products and regularly sanitized. Salmonella was the leading cause of food recalls in the fourth quarter of 2012.
• Listeria: Listeriosis is an illness that results from eating food such as uncooked meat or unpasteurized cheese that has been contaminated with Listeria monocytogenes. While the bacteria can be killed through pasteurization or cooking, listeria contamination can also occur following food production and prior to packaging. This makes prevention and control of contamination particularly difficult. Employee food safety education as well as regular sanitation of refrigeration devices will aid in limiting the risk of Listeria contamination.
• Botulism: Fifteen percent of all reported Botulism cases are foodborne and are preventable. While many cases are due to improper home canning methods, commercial food producers need to be aware that Botulism cases have been reported in food products such as tomatoes and chili peppers.
• E. coli: According to the CDC, many strains of E. coli are harmless, while others can cause serious illness. E. coli bacteria can be transmitted through water, food or contact with animals, but the major source of human illness from E. coli comes from cattle. The data in the most recent ExpertRECALL Index indicates that E. coli drives only a small number of food recalls, but because it can be difficult to identify the contamination source, an E. coli contamination has widespread impact and is a serious threat to food production safety.

In the event of a food recall due to the risk of foodborne illnesses,a quality management system can improve your recall process. To be in compliance with FDA regulations, once it is determined that a recall is necessary, the FDA must receive all product-related information, including the volume of food product that was produced. Tracking these details in a proactive system during production will speed up the process of reporting food production details during a recall and also allow companies to have better control over their recall process.

When it comes to food safety, there is an understandably low tolerance for risk among regulators and consumers. Anticipating the systems that will need to be in place in the event of a recall due to food contamination will not only ensure an efficient and effective recall, but also will likely aid in the future prevention of a recall. Risk is omnipresent, and so establishing processes that track information such as volume, date and time of food production can mitigate the risk a lengthy and disorganized recall as well as the risk of not being compliant with the FDA.

What has been your most effective tactic to limit the risk of food contamination? We welcome your comments and opinions 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.

For starters, the FDA is conducting more domestic inspections. According to a recent Food Safety Magazine article, the FDA is completing over twice as many inspections per year than it was 10 years ago. The FDA is focusing on products that are considered “high risk,” and targeting specific industry segments after an outbreak of foodborne illness. Some of the risk factors that the FSMA identifies for declaring a domestic food facility to be high risk include known safety risks of the food as well as the compliance history of the facility.

Before the FSMA is fully implemented, food companies must take steps to adapt to the FDA’s regulations well in advance. Here are three key points to consider when adapting to new regulations:

1. Audit your record keeping: Assess your readiness to adhere to more robust record keeping requirements now; this includes assessing current records and instigating proactive monitoring of all production details including volume, date and time of food products.
2. Inspection-ready: With increased frequency and thoroughness of FDA inspections, stay ahead by conducting mock inspections as well as training sessions on your food safety practices. Additionally, be aware of your rights and responsibilities during an FDA inspection and develop a relationship with your inspectors and local FDA authorities to show your commitment to safety and compliance.
3. Maintain standards: Even companies with a strong history of compliance run into problems. The ability to respond quickly and effectively to a safety concern is vital to maintaining a robust food safety program.

While the FSMA does grant the FDA authority to mandate a recall, meeting inspection requirements, quickly addressing and rectifying food safety concerns, and activating a voluntary food recall when necessary will aid in preventing the receipt of a “last chance” letter from the FDA.

What questions do you have about preparing for new regulatory changes from the FSMA? Share your questions with us 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.

Through this recall workshop, participants recognized the need for a crisis management plan and learned best practices for ensuring the safety of their products in adherence with the Consumer Product Safety Improvement Act (CPSIA). Additionally, members learned how to work in congruence with the Consumer Product Safety Commission (CPSC) in the event of a recall.

While the CSPIA guidelines address the safety of children’s products, they are also resourceful in informing the best practices for a sporting goods product recall. The sports and fitness industry has seen a steady growth in consumer demand over the past three years and with the uptick in technology-enabled products, it is imperative for companies to ensure that their products are not only running with technological superiority, but also in adherence with the CPSC’s regulations. Maintaining an up-to-date recall plan in-line with advances in product technology will keep the recall process efficient and streamlined.

In running a mock recall to prepare for a crisis situation, here are some key questions to ask when drawing out the recall plan:

Deciding to recall

• What are the potential hazards being reported?
• What is the volume of products that would be recalled?
• How serious is the product defect?
• Is the CPSC aware and working alongside in this investigation?

Recall Action Plan

• What are the first steps to take?
• Is your recall strategy up to date?
• Does your strategy involve third-party assistance?
• When and where should the CPSC be advised of actions to be taken?

Documenting the process

• Are all consumer complaints recorded?
• What is the health hazard involved?
• What were the return/corrected product changes?
• How is the final disposition of the returned product taking place?

A recall can be a very trying crisis situation for a consumer good or product. Conducting a mock run of the recall process keeps the team’s preparedness and confidence intact, should an adverse event arise.

What additional questions you would ask when creating a recall plan? We welcome your suggestions 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.