Food quality is mainly composed of three aspects: safety, shelf life and consistency. A food product must not contain levels of contaminants such as pathogens or toxins that are likely to cause illness upon consumption. It must not contain contaminants at a level where it becomes organoleptically spoiled in an unacceptably short time. Additionally, snacks and baked foods must be of consistent quality regarding safety and shelf life. For example, the consumer will not accept cookies, crackers or even croissants that display large batch-to-batch variations in shelf life.

Access to sufficient amounts of safe and nutritious food is key to sustaining life and promoting good health. Unsafe food containing harmful bacteria, viruses, parasites or chemical substances causes more than 200 diseases, ranging from diarrhea to cancers. Food safety is about handling, storing and preparing food to prevent infection and ensure that food keeps enough nutrients for a healthy diet. However, it can become contaminated at any point during production, distribution and preparation. Everyone along the production chain, from producer to consumer, has a role to play to ensure the food we eat does not cause diseases.

Baking and snack industries are not immune to food safety problems: salmonella and E. coli in flour, glyphosate in breakfast cereals and snacks, arsenic in infant rice cereals, acrylamide in animal crackers, gluten in “gluten-free” products; the list goes on.

Regulatory agencies and the food industry are the two bodies most actively interested in determining and controlling the quality of food products. Regulatory authorities aim to protect the public from hazardous or inferior goods with regulations and laws. Food companies must make sure that their brands are consistently safe to protect and enhance their reputation on the market.

Julie Miller Jones, Ph.D., C.N.S., L.N., fellow of AACCI and ICC, expert with the Grain Foods Foundation and professor emerita, Foods and Nutrition, St. Catherine University, said food safety in any operation is basic to success, and food safety for the baking and snack industries, like any food industry, is a farm-to-fork activity.

“Any hint of something that is amiss can wipe out years of a stellar reputation,” she said. “Climate change, new ingredients or varietals, new or revised processes, new suppliers and regions, and trends toward clean labels and less processing require even greater vigilance.”

Defining the terms

When exploring the Food Safety Modernization Act (FSMA) and food-safety practices in general, it’s good to start from a place of understanding. For example, absolute safety and absolute risk are impossibilities, but relative food safety is achievable.

“Absolute safety is the assurance that damage or injury from use of a substance is impossible and absolute risk is unattainable since some risk exists with any food, any chemical or, indeed, any human endeavor,” Dr. Miller Jones explained. “Relative food safety can be defined as the practical certainty that injury or damage will not result from a food or ingredient used in a reasonable and customary manner and quantity.”

Toxicity and hazard are both words that come into play when considering what the risk to human or animal health is.

“Toxicity is the capacity of a substance to produce harm and injury of any kind (chronic or acute) under any conditions,” Dr. Miller Jones continued. “Hazard is the relative probability that harm or injury will result when the substance is used in a proposed manner and quantity. Assessment of whether a food or ingredient is safe should not be based on inherent toxicity but on whether or not a hazard is created.”

When managing food safety, bakers need to identify the hazard, risk factors that raise the frequency and degree of those hazards, and processes necessary to reduce that risk. These hazards can be chemical, physical or microbiological and be a result of human error or simply the effects of nature.

“Given that the events at any one stage of the supply chain can have an impact on consumer health, international best practice in respect of food safety management considers the supply chain as a continuum,” said Anton Alldrick, special projects manager, Campden BRI. “Recognizing this through adoption of a field-to-table approach enables an understanding of both where hazards can be introduced and the attendant risk factors.”

Types of food safety hazards potentially associated with cereal/grain-based foods include microbiological, pesticides, fungal (mycotoxins), allergens, heavy metals, natural and process-induced food toxicants, external materials, fraud and sabotage.

Divvying up responsibilities

The Food and Drug Administration regulates all foods and food ingredients introduced into or offered for sale in interstate commerce, with the exception of meat, poultry and certain processed egg products regulated by the U.S. Department of Agriculture. Facilities that manufacture, process, pack or hold food that is intended for human or animal consumption in the United States must register with the F.D.A. before beginning these activities.

Food manufacturers, processors, packers, transporters, distributors, receivers, holders and importers are required to establish, maintain and make available certain records to the F.D.A. upon request. These records will allow the agency to identify all food products handled by the facility. For instance, if any business is required to register under the Bioterrorism Act and makes cookie dough that is subsequently baked and packaged by another facility, the records must include the names and addresses of the facilities from which they get their ingredients, plus the names and addresses of the facilities where they send their dough to be baked and packaged. This is also known as “one up, one down” in the distribution chain.

Food manufacturers are responsible for developing labels including nutrition information that meet legal food-labeling requirements. Registered facilities must report when there is a reasonable probability that the use of or exposure to an article of food will cause serious adverse health consequences or death to humans or animals.

Recently, the F.D.A. amended the regulations pertaining to the Nutrition Facts and Supplement Facts labels, effective Dec. 21, 2018. The amendments correct errors that were made in labeling examples, restore incorrect deletions, rectify the addition of a reference cited in the rule and cross-references to other regulations, including baking and snack industries.

Responding to FSMA

Signed into law in 2011, FSMA enables the F.D.A. to ensure food safety by preventing microbial contamination rather than reacting to the problem after it already has occurred. Under FSMA, the food industry is systematically putting in place measures proven effective in preventing contamination.

Unless specifically exempted by FSMA, each facility must be evaluated for hazards that could impact the food manufactured or stored in the facility. Once those hazards are identified, preventive controls must be put in place to minimize those hazards. Those in charge of each facility must provide assurances that such food is not adulterated or misbranded; monitor the performance of those controls; and routinely maintain records.

FSMA is built upon a premise that it explicitly embraces and enhances the food safety role of the food industry. For an effective food safety management, it is essential to consider the sanitary design of plants, equipment and procedures, as well as the human factor. Hazard Analysis Critical Control Point involves a specific process for defining critical parameters around the food, identifying potential hazards and determining control measures for those hazards that are likely to occur in the food processing system. Total quality management incorporates improving both the organization and people involved with producing the product. Standard operating procedures for managing current good manufacturing processes (cGMPs) and food safety plan preventive controls provide consistency in the food safety aspects of the manufacturing environment and the safety of the product. Record keeping for FSMA includes records that go beyond those that are maintained during the day‐to‐day operation of the food safety plan. FSMA regulations have specified that a facility must have a recall plan as a preventive control measure.

The F.D.A. recognizes that ensuring the safety of the food supply is a shared responsibility among many different points in the global supply chain for both human and animal food, and in recognizing that, the agency has finalized seven major rules to implement FSMA. These are designed to clarify specific actions that must be taken at each of these points to prevent contamination.

These rules include cGMPs and hazard analysis and risk-based preventive controls for both human and animal food. They also require manufacturers to have accredited third-party certification, foreign supplier verification programs (FSVP), mitigation strategies to protect food against intentional adulteration, a voluntary qualified importer program (VQIP) and standards for growing, harvesting, packing and holding produce for human consumption. Food manufacturers also have to establish sanitary transportation of human and animal food.

Erdogan Ceylan, Ph.D., fellow of Mérieux NutriSciences, said domestic and foreign food facilities that are registered with section 415 of the Food, Drug & Cosmetic Act must comply with FSMA. They must implement a written food-safety plan that includes hazard analysis, preventive controls and procedures for monitoring corrective action and verification.

“Food facilities have the flexibility to customize preventive controls in their food safety plan,” Dr. Ceylan said. “The plan should be validated to obtain scientific and technical evidence that a control measure, when properly implemented, is capable of effectively controlling the identified hazards. Validation of the preventive controls must be performed (or overseen) by a preventive controls qualified individual.”

Preventive controls should cover process, food allergens, sanitation, a supply chain program, recall plans and other controls that might be specific to the facility and the product. Facilities should monitor and verify these items, take corrective actions when necessary and keep records.

AIB International is committed to helping companies move beyond basic food safety compliance to create a proactive, strong food safety culture, noted Stephanie Lopez, vice-president of operations, AIB International. FSMA should be a good starting point — a baseline — for the industry, she said. As consumers demand more transparency, only companies with strong food safety plans in place will endure.

“Strong food safety cultures and quality programs build strong relationships of trust between brands and consumers that fosters brand loyalty,” she said.

There will be extensive industry outreach so that everyone who seeks to comply with these rules, whether legally required to or not, understands the new requirements. The F.D.A. recognizes that training is essential for bakeries to effectively comply with FSMA, and the agency has worked training and education into the rules.

“While members of the food industry are ultimately responsible for getting the training they need to comply with the FSMA rules, F.D.A. recognizes the importance of its role in facilitating that training,” the F.D.A. stated in its guidance for FSMA training. “For the agency, this means joining with public and private partners in state, federal, tribal and international governments, industry and academia in the development and delivery of training.”

Industry resources also have been developed to assist in education so that all will be in compliance in time.

“AIB International supports companies with a comprehensive range of food safety and quality services for every part of the supply chain ranging from research and product development to inspection and consulting to Global Food Safety Initiative certification and training to quality management,” Ms. Lopez said.

FSMA is the largest change in U.S. food regulations since 1938. The Center for Food Safety and Applied Nutrition estimates a turnover rate of 33% for F.D.A.-regulated facilities. Accordingly, it is crucial to stay in-the-know on upcoming compliance dates, requirements, and tips and tricks to maintain and track food safety progress. To ensure that personnel perform their jobs well, appropriate training and maintaining food defense records, corrective actions, and verification activities must be evaluated.