With the recent passing of the Food Safety Modernization Act, what’s ahead for the food industry and how is it preparing to meet the changes head-on? Editor-in-Chief Lauren R. Hartman talks with several organizations that provide insight and advice for many of today’s bakers and snack producers.

Safety. It could be the most important aspect of purchasing, eating and cooking food, as well as the most important in the food supply chain in this country. Overwhelming amounts of information, including reports, press releases, association statements, online blogs, social media articles, opinions and more have been generated about this serious subject.

According to recent data from the Centers for Disease Control and Prevention, nearly 48 million people (one in six Americans) get sick, 128,000 are hospitalized and 3,000 die each year from foodborne diseases. This is a significant public health burden that is largely preventable.

Since the U.S. Food and Drug Administration imposed the new Food Safety Modernization Act (FSMA), passed by Congress in January, many bakers and snack food manufacturers are gearing up to accommodate the changes (also see accompanying Food Safety Workshop sidebar). But many are still confused as to how, when and if these new regulations will be implemented.

The FDA created the new law because foodborne illness is largely preventable if everyone in today’s global food chain could be held responsible and accountable at each step for controlling hazards that can cause illness. However, that is easier said than done.

“Right now, many suppliers and bakeries are reviewing their internal programs to see where they stand,” says Gary Ades, president of G&L Consulting Group, LLC, Bentonville, Ark., and the chairman of the executive education council for the Food Safety Summit, April 19-21 in Washington, D.C. The Food Safety Summit is produced by BNP Media, parent company ofSnack Food & Wholesale Bakery.

Ades and his group have been reviewing client food safety programs and benchmarking against best practices. “What many want to know is, ‘does FDA have sufficient qualified resources and funding to accomplish the [new] goals?’ Our organization offers educational training and information, and public health officials are also a good source of information and assistance yet are often overlooked. Get to know your local public health officials before there is a problem,” he advises.

Robb MacKie, president and CEO of the American Baking Association (ABA), Washington, D.C., says that the new requirements to audit sources of ingredients will impact baking and snack suppliers. “This is particularly true for ingredients sourced outside of the U.S.,” he says. “This is one area where we’re not sure if FDA understands all of the ramifications. There will be opportunities in the rule-making process to seek further clarification on the requirements.”

MacKie says that ABA members have been implementing Good Manufacturing Practices (GMPs) to reduce potential food safety issues for some time. “That doesn’t mean the practices are flawless, but we are fortunate as an industry to have had so few incidents,” he notes. “ABA’s Food Technical and Regulatory Affairs Committee (FTRAC) has been exploring common sense improvements in food safety for decades, and we are working hard to educate members on the recently enacted food safety bill.”
MacKie points out that ABA has already conducted an informational webinar in conjunction with the AIB about food safety, and the FTRAC is focusing on compliance at its ABA meetings this year.

More training needed
The baking industry has responded to the new legislation with a realization that expanded training will be required, says a team from AIB International, Manhattan, Kan., which collectively answered questions for this special report. The team is led by Jim Munyon, president and CEO; Maureen Olewnik, vice president of audit and technical services; Bill Pursley, vice president of food safety education; Brenda Stahl, director of microbiology; and Brian Soddy, vice president of marketing and sales.

“This expanded training will include both general understanding of the new regulations, as well as, continued training on its basic requirements: hazard analysis and prevention control (including radiology), traceablity, etc.,” the AIB team says. “Diligence in record-keeping and management of programs will also have to be enhanced. These additional requirements are in line with activities required in certification schemes, and will be further delineated by FDA as the program requirements are finalized.”

Nicholas Pyle, president of the Independent Bakers Association (IBA), Washington, D.C., which says his group acted to shepherd the legislation to the best outcome, indicates that bakers and snack companies should watch out for comprehensive and lengthy inspections to be more about record-keeping compliance and less about actual manufacturing operations. “The [updated] food safety bill is a record-keeping bill with associated fines and penalties,” he says. “Most of my conversations [with bakers] have been regarding traceability information from suppliers. They are now responsible for accounting for all their inputs (by lot), from seed to store shelf. Thus, bakeries and snack companies are actively looking at compliance methodologies and staffing to meet the record-keeping provisions.”

Along with plenty of other information, IBA offers a guide for bakers on how to manage recalls, and directly assists bakers in managing the media in past cases of product tampering, Pyle explains.
Bakers and snack food manufacturers also want to know how the new law will change the way FDA regulates food. The answer? By putting prevention up front. For the first time, FDA will have a legislative mandate to require comprehensive, science-based preventive controls across the food supply. Preventive controls include steps that a food facility can take to prevent or significantly minimize the likelihood of problems occurring. Under the FSMA, implementation of mandatory preventive controls for food facilities and compliance with mandatory produce safety standards will be required. And, FDA now has the power to order a product recall.

To assist bakers and snack food manufacturers with food safety questions and issues, AIB on Jan. 28 provided a well-attended webinar on the practical approach to the FSMA. Among other food safety-related programs, AIB also developed a resident training course that offers four weeks of practical review of the new requirements, as well as, hands-on activities demonstrating the requirements of basic GMPs, Hazard Analysis Critical Control Points (HACCP), food defense and other requirements of a well-run food safety program.

AIB, which supports the new food safety legislation, says the American Baker’s Association (ABA), itself and other industry association partners have been actively working with the American Frozen Foods Institute (AFFI) in a coalition focused on working with FDA to update and improve the current GMPs. A recent document submitted to FDA by this group aims to provide the food industry with guidance for establishing and monitoring GMPs within food production facilities, as well as providing FDA with a set of principles and practices the agency will hopefully utilize in developing further guidance on GMPs.

FDA is in the process of developing a proposed rule that will establish science-based minimum standards for the safe production and harvesting of fruits and vegetables and will address soil amendments, worker health and hygiene, packaging, temperature controls, water and other issues. Food facilities will be required to implement a written preventive control plan, provide for the monitoring of the performance of those controls and specify the corrective actions the facility will take when necessary.

Like many food companies, bakers and snack producers will see the FSMA progress slowly, Ades says. AIB agrees, saying the new programs will most likely require facilities to review, augment and enhance existing programs, including training, HACCP, traceability, record-keeping, vulnerability assessment and more. “Practically speaking, certain elements must be addressed immediately, and many must wait for FDA rule-making to occur,” says the AIB team. “Developing details of the bill’s requirements will require at least two to two-and-a-half-years of effort on the part of FDA.”

Says MacKie, “One of ABA’s significant achievements in the legislative process was in shifting very prescriptive legislative mandates to FDA for proper rule-making. This will allow ABA to offer the baking industry’s perspective and seek further clarification of the law’s requirements.”

FDA is aware that it may take a while before the food system is safer. “A long-term process will be needed to build a new food safety system based on prevention,” it states on its website, fda.gov. Congress established specific implementation dates in the legislation. Some authorities will go into effect quickly, such as mandatory recall authority, while others require FDA to prepare and issue regulations and guidance documents. FDA says it’s committed to implementing the requirements through an open process with opportunity for input from all stakeholders.

“The record-keeping requirements all along the supply chain mean massive redundancy of paperwork,” says Pyle. “One can only hope the process will move towards streamlining and shared efficiencies.”

What will it cost?
Costs are also a critical factor when it comes to FDA enforcement of the bill. And, with the recent economy decline, manufacturing is still nowhere close to being financially fit. “A lot of these companies say they aren’t sure what [specifically] will be required,” says Ades. “More funding is going to be necessary in order for the FDA to carry out these new regulations. But the jury is still out as to whether or not it gets them.”
ABA’s FTRAC will be spearheading industry input to FDA, says MacKie. “We cannot emphasize enough the importance of baking companies’ participation in the FTRACs efforts,” he says. “These are complex and potentially costly issues, and we will be looking to members to offer suggestions on how to achieve improved food safety that builds on current industry practices and successes without unduly burdening the industry. Going forward in the current budgetary environment, it is difficult to envision FDA receiving significant new resources,” MacKie continues. “…it is imperative for the food industry to work hard at self regulation and continuous improvement.”

The funding that FDA reports it has available is coming through the annual budget cycle. Fees impacts the number of full-time equivalents (FTE) it has and will be a factor in the way that FDA handles its significant and far-ranging activities, including the way this legislation is implemented. The inspection schedule in the legislation would increase the burden on the agency’s inspection functions, for example. Without additional funding, FDA will be challenged in fully implementing the legislation without compromising other key functions. “We look forward to working with Congress and our partners to ensure that we are funded sufficiently to achieve our food safety and food defense goals,” its website states.
AIB notes that it is a member of the Alliance for a Stronger FDA, a collaboration of members who ensure that the FDA has sufficient resources to protect consumers. “We have been instrumental in providing input on FDA activities and in supporting FDA in their request for funding,” says the AIB group. “More funding will probably be necessary in order to carry out the requirements of the act. We cannot speculate on what the impact will be, as the rules have not been finalized and each situation will be different.”

But there are obstacles to funding. A recent proposal by conservative House of Representative Republicans to cut and freeze non-defense, discretionary spending from 2011 to 2021, could impact food safety funding because they intend to cut spending across the board from more than 40% of every U.S. government sector, except Social Security and a few other areas. The jury is still out as to whether the plan will move forward, but some Republicans question whether food safety even warrants greater spending.

“The ‘pay’ for the new measure was a significant cause of the holdup in the legislation,” Pyle notes. “We [the IBA] are pleased that a $500-per-facility fee was not included in the final law. But IBA is concerned about possible user fees that could be included. We feel these are fees imposed simply for the privilege of regulation.”

Five key elements of the law
The major elements of the new Food Safety Law can be divided into five key areas:
    •    Preventive controls-For the first time, FDA has a legislative mandate to require comprehensive, prevention-based controls across the food supply.
    •    Inspection and compliance-The legislation recognizes that inspection is an important means of holding the industry accountable for its responsibility to produce safe food; and the law specifies how often FDA should inspect food producers. FDA is committed to applying its inspection resources in a risk-based manner and adopting innovative inspection approaches.
    •    Imported food safety-FDA has new tools to ensure that those imported foods meet U.S. standards and are safe for our consumers. For example, for the first time, importers must verify that their foreign suppliers have adequate preventive controls in place to ensure safety, and FDA will be able to accredit qualified third-party auditors to certify that foreign food facilities are complying with U.S. food safety standards.
    •    Response-For the first time, FDA will have mandatory recall authority for all food products, but it expects that it will only need to invoke this authority infrequently because the food industry largely honors its requests for voluntary recalls.
    •    Enhanced partnerships-The new legislation recognizes the importance of strengthening existing collaboration among all food safety agencies-U.S. federal, state, local, territorial, tribal and foreign-to achieve public health goals. And, it directs FDA to improve training of state, local, territorial and tribal food safety officials.

What more should be done with imported raw materials? The AIB team says that FDA and the U.S. food industry are concerned about food products being imported to the U.S. from all parts of the world. “The new legislation requires that food production facilities exporting into the U.S. meet the same safety and sanitation requirements expected of facilities producing food in the U.S. Thus, international food producers will, in the future, be required to be audited by a third-party checking against audit criteria provided by FDA,” the team reports.

Avoiding product recalls
Out of all of the product recalls in 2010, including the massive one at Wright County Eggs last summer that garnered hundreds if not thousands of news headlines, the egg recall of 2010 was perhaps the most widespread. That recall expanded to farms scattered across the country until it grew to more than half a billion eggs nationwide.

But it’s no wonder that consumers often grow tired of hearing about recall news. “Consumers care about product recalls as well, but are becoming numb [to these reports] based on the large increase in recent recalls,” says Ades. “Though it seems there have been fewer recalls at bakeries than in other types of facilities, bakers and snack food companies have always had a [high-heat] kill step (baking or frying) that addresses product recall issues related to biological issues. Their main concerns are physical: glass; plastic; chemicals-most importantly allergens-either not identified or incorrectly identified. Undeclared allergens account for the largest number of recalls in the food industry. Allergen management is another major issue.”

Though by and large, baking and snack producers have experienced a very low recall incident rate, yet they shouldn’t be complacent. Recalls are devastating regardless of the food product involved, the AIB team agrees. “Bakery and snack goods are most often recalled due to misbranding or allergen-related issues.”

Adds Pyle, “There’s nothing new there. For many years, bakers and allied ingredient suppliers have utilized GMPs, HACCP and related record-keeping. This [new] legislation doesn’t mandate any new kill steps or manufacturing changes, just record-keeping.”

Ideally, says MacKie, if in addition to all of the screening of inbound ingredients there was a detection system or method for most common pathogens and allergens at some point, “this would allow for early detection, correction before product ever left the manufacturing plant. This type of technology is likely many years away from being commercially viable.”

Crisis planning
So how will this law make imported food safer? Consumers in the United States enjoy the benefit of imported foods from more than 150 countries. The FSMA gives FDA new tools to ensure that those imported foods meet U.S. standards and are safe for U.S. consumers. New authorities under the Act include:
    •    Importer accountability-Importers must verify that their foreign suppliers have adequate preventive controls in place to ensure safety.
    •    Third-party certification-FDA will be able to accredit qualified third-party auditors to certify that foreign food facilities are complying with U.S. food safety standards.
    •    High-risk foods-FDA now has the authority to require that high-risk imported foods be accompanied by a credible third-party certification as a condition of admission into this country.

Additional resources are directed toward foreign inspections. FDA now has the authority to refuse entry into the United States of a food that has failed U.S. inspection. FDA expects to hold briefings on the new legislation for its colleagues in embassies in Washington, and to brief the World Trade Organization on the new legislation.

If a food safety threat does exist, it’s usually addressed as quickly as possible, says Ades. “Ingredients are sourced from all over the world,” he adds. “One of the keys to food safety is knowing and monitoring your suppliers.” But until the FSMA was passed, all too often, processors and other food companies often improved their practices after a crisis rather than before. “It’s difficult to convince [manufacturers] to spend the money for the ‘insurance policy’ that crisis planning affords,” Ades explains. “This is especially true if they have never had a problem [before]. It’s best to plan for a crisis before, not during one or after it occurs.”

In 2003, AIB acquired the Baking Industry Sanitation Standards Committee (BISSC) initiatives, the requirements for which apply to the design, construction and cleaning of various bakery equipment, accessories and components. The BISSC provides a certification and third-party validation program for equipment manufacturers. The certification process helps to assure the baker or snack food manufacturer that the equipment they install in their facilities will help in their efforts to produce safe quality foods.

The BISSC reports that bakery equipment must adhere to the American National Standards Institute (ANSI) safety requirements code (the latest version of Z50.1), and should be observed in the manufacture, installation and operation of bakery machinery and equipment. The initiatives are currently being reviewed and examined by BEMA in relation to the FSMA. “We are very involved in moving the standards into the American National Standards Institute accreditation process,” says Kerwin Brown, president and CEO of BEMA, Overland Park, Kan. “This law is very important to us. We helped formulate the Sanitation Summit, which was held in February and also hired consultants to work on the BISSC/ANSI initiative.”

Help is available
Traceability systems also can be a major benefit to producers because they pin-point the source of an outbreak of foodborne illness, especially tricky considering the enormity of the supply chain. “Bakery equipment should meet BISSC certification and ISO (International Organization for Standardization) standards, and be operated and cleaned according to manufacturer recommendations,” says Pyle.

Track-and-trace systems are used frequently to reduce ingredient losses, improve plant productivity and profitability and share data with enterprise resource planning (ERP) and materials requirements planning (MRP). “Programs are/have been in place for some time regarding tracability,” says the AIB team. “The food industry continuously monitors and develops better methods of product and ingredient traceability and management. We have many methods that can be used to determine sanitation efficacy and broad microbial levels in snack food plants with a detection time of 10 hours or more. We have rapid testing kits allowing for immediate notification of allergen contamination at detection levels of 0.15 µg or higher.”

In terms of microbial awareness, AIB’s ongoing research helps provide methods that ensure a real-time measurement in less than eight hours, the AIB team reports.

Other systems that can help a baker’s efforts to comply with the FSMA include inspection/detection equipment, marking and coding technology, thermal processing to achieve sterility, radio-frequency identification tagging and more. New types of equipment will most likely be developed to accommodate this task, and will be a key opportunity for equipment providers, says Ades.

IBA often meets and speaks with the Environmental Protection Agency, the Occupational Safety and Health Administration (OSHA), FDA, the U.S. Department of Agriculture (USDA), the Department of Defense, as well as, state and local entities to educate them about the complexities of baking operations and member-compliance issues, Pyle explains. “All of these agencies consider their role as protecting health and the environment.”

AIB provides equipment manufacturers and bakers with seminars and on-site training that cover food safety requirements of equipment design. The information shared during these programs can help equipment design and bakery or snack food engineers achieve the right formats to enhance food safety and production efficiency. “Customers need and expect expertise in training and inspection/audit activities,” the team says. “The bar will continue to be raised as technology, logistics and program management capabilities progress and improve. Offering this level of service is what the industry expects of AIB.”

A complete food safety culture
It’s not easy, but in order for a company to really protect its food products, it must develop a complete food safety culture that goes beyond the basic measures of regulatory compliance to successfully tackle food safety issues. “Without a management commitment, food safety is just an afterthought. Management commitment is the basis for food safety,” Ades sums up. “Cultural change takes time and sustained commitment. You must have a full-time food safety professional in the organization who has the necessary resources and reports to a high enough level in the company to have authority to put food safety systems in place and support them.”

MacKie says he doesn’t know of a baker who doesn’t think and act like food safety is a top priority. “I am fortunate to visit many ABA members and regardless of size, products and location,” he points out, “they all pride themselves in their good manufacturing practices and their food safety audit scores. I have seen it first hand in the facilities I have visited.”

Many of the associations also provide training and seminars. AIB conducts physical inspections and training on how to self-inspect food facilities, as well as offer records-based certification audits. Inspections and training programs can be customized for a facilities’ specific need and may include vulnerability assessment, environmental monitoring programs and the basics of HACCP and GMPs. AIB also offers scheduled seminars, on-site training and Internet-based courses and webinars. ABA and AIB also recently presented a joint membership call on the legal aspects of the new FSMA.

“The food industry recognizes that each facility focus on food safety has to be a team effort from the president down,” says AIB. “Our membership and active involvement with ABA’s FTRAC allows us to participate in open and honest industry discussion with industry members about issues critical to food safety.”

Programs and opportunities
In 2008, FDA implemented the Reportable Food Registry (RFR), a program whereby when a facility becomes aware of a food safety issue, it must immediately report the situation to FDA through an RFR portal. The company also must inform if the product may have been delivered containing a potential food safety risk. If the food safety issue didn’t originate at the facility in question, the company must also inform the organization that shipped out the product.

AIB offers seminars covering RFR, as well as, measures and direction on linking corrective action with methods of documenting and managing the threat. Each case is different and requires trained and qualified personnel to manage it.

Any crisis at a food industry operation should serve as a learning opportunity, Pyle says. “Manufacturing practices constantly evolve to increase efficiencies, safety and production. We in the United States are blessed with the safest food supply in the world. Most U.S. operations are already in the culture of HACCP and GMP, so we just don’t see a big ‘food safety problem.’ Yet we can see hyper-sensationalized press accounts about this farm or that producer cutting corners, compromising food safety and they seem to get their comeuppance, and in some cases, jail time.”

Equipment Design/Plant Design Workshop a Real Eye-Opener

One way bakers and snack food producers can find out more about how to increase their products’ safety is by attending one of the myriad seminars, workshops or meetings hosted by their key industry associations. Concerns in the United States about food safety have never been higher. If you plan to purchase or design equipment for a production facility that produces low-moisture food products, then food safety is your responsibility. With the vast amount of information made available by food industry associations, there’s plenty of help for engineers, sanitarians and plant personnel to gain more understanding of how to best protect food supply.

Based on the overwhelming response to earlier workshops on this subject, a third Food Safety Equipment and Plant Design Workshop for Allergen/Pathogen Control took place in Chicago, Feb. 8-9, and proved to be a highly informative eye-opener. The event focused on what the food industry can do to achieve the proper equipment, plant and process design-targeting allergens and low-moisture pathogens-to best promote food safety.

That statement was a prevalent theme during the seminar, which was sponsored by food industry associations, including AIB International (AIB), American Bakers Association (ABA), American Society of Baking (ASB), the Biscuit and Cracker Manufacturers’ Association (B&CMA), Baking Equipment Manufacturers and Allieds (BEMA), National Confectioners Association, Food Processing Suppliers Association (FPSA), National Pasta Association (NPA) and the Snack Food Association (SFA), as well as the GMA (Grocery Manufacturers of America), whose Sanitation Committee members and member companies provided the workshop content.

The large group of attendees explored various topics such as wet cleaning versus dry cleaning methods, lot-and-line segregation for a clean break, controls for pathogens and allergens, challenges and obstacles in sanitary equipment design, regulatory concerns, what the new Food Safety Modernization Act (FMSA) means to equipment manufacturers and food producers and startling lessons learned the hard way by some of the country’s top food producers who have experienced product recalls and plant shutdowns. Attendees also participated in exercises that challenged how long it takes to clean small parts and huge production machinery, how to design equipment that’s easier to clean and how to create a Sanitation Standard Operating Procedure (SSOP) for a piece of equipment. The group also learned about practical and proven approaches to equipment and plant cleaning and sanitary design, the liabilities associated with failed equipment and facility designs and the importance of using equipment and plant design checklists (some of which have been created as guidelines by the GMA) to evaluate low-moisture food compliance with GMA Sanitary Design Principles.

“The Food Safety Modernization Act represents the most significant expansion of food safety requirements and FDA food safety authorities since the original enactment of the Food Drug & Cosmetic Act in 1938,” stated Warren Stone, director of compliance and inspection at GMA. “The new act grants FDA with a number of new powers, including mandatory recall authority. Food facilities will be inspected with greater frequency and not less often than once every five years.”

In addition to the association presenters, Jenny Scott, senior advisor of the Office of Food Safety, Center for Food Safety and Applied Nutrition at the U.S. Food and Drug Administration provided a phoned-in presentation on FDA’s perspective on equipment sanitary design. “While FDA regulates foods and does not regulate food processing equipment, FDA does regulate the sanitary use of this equipment,” she said. “Prevention is the name of the game, as FDA commissioner Margaret Hamburg, says...Equipment manufacturers have a responsibility with respect to cleaning and sanitation. Sanitary design cannot be secondary to functionally of equipment.” Scott added, “Equipment design engineers need to work with sanitarians, quality assurance, microbiologists and food technologists to assess designs for areas that are difficult to clean. Design to allow quick access to hidden areas and make equipment easy to disassemble and assemble.”

For more information on these and other food safety-related events, visit any of the following associations: AIB International at www.aibonline.org, GMA at www.gmaonline.org, BEMA at www.bema.org, ASB at www.asbe.org, Independent Bakers Association at
www.independentbaker.net, ABA at www.americanbakers.org and SFA at www.sfa.org.