A Look at GMPs: How FSMA Will Change Expectations
By Michael Cramer, CQA
In 1938, Congress passed the Federal Food, Drug, and Cosmetic Act (FD&CA) that covers all commodities, except meat and poultry products, for which the U.S. Department of Agriculture has responsibility, in interstate commerce from harvest through processing and distribution. In 1969, the first Good Manufacturing Practices (GMPs) were published as Part 128 of the Code of Federal Regulations (C.F.R.). The C.F.R. is divided into approximately 50 titles, and Title 21 deals with food and drugs. The GMPs were recodified in 1977 as Part 110 of the C.F.R., and they explain GMP requirements that cover all aspects of food manufacturing from employee requirements to facility and equipment design and cleaning.
In January 2011, President Barack Obama signed into law the Food Safety Modernization Act (FSMA), which allows the U.S. Food and Drug Administration (FDA) to better protect human and animal health by ensuring food supply safety and security, focusing on prevention of food safety hazards rather than on reaction to foodborne illness or injury. FSMA also provides FDA with new authority to enforce compliance with “risk-based prevention standards.” The mandate is that food facilities will implement preventive controls that include the following:
• Evaluate hazards that impact food safety
• Specify preventive steps or controls to minimize or prevent hazards
• Identify monitoring of the controls to ensure they are working
• Require maintenance of monitoring records
• Specify actions to be taken to correct problems that arise
A Higher Bar for Manufacturing Practices on Produce
As a result of incidents of foodborne illness linked to raw agricultural foods and produce, FSMA also includes mandatory produce safety standards. The intent of this section of the law is to ensure that produce is safe and reliably verified to be safe; consequently, FDA must establish science-based minimum standards for the safe production and harvesting of fruits and vegetables. This includes both domestic and imported produce, and standards must consider naturally occurring hazards as well as those that may be introduced unintentionally or intentionally. FSMA provides for mandatory requirements with regard to hygiene, planting, growing, harvesting, packing and storage of produce. Included in these requirements are the safety of soil amendments (i.e., manure, compost), control of animals in growing fields, agricultural water quality (surface and ground) and tool and utensil controls for food safety.
Finally, FDA will have authority to prevent intentional contamination. FDA must issue regulations to protect against the intentional adulteration of food, including the establishment of science-based mitigation strategies to prepare and protect the food supply chain at specific vulnerable points.
Effects of FSMA on GMP Regulations
FSMA rules also modernize current GMP (cGMP) regulations regarding manufacturing, processing, packaging and holding of human foods. The last major update was in 1986, when a reference to Hazard Analysis and Critical Control Points was included and stipulated a need to control “undesirable microorganisms.”
FSMA clarifies compliance dates for establishments subject to the final rule and amends regulations for cGMPs for both foreign and domestic facilities required to register under the FD&CA. Traditionally, the sections identified in 21 C.F.R. 110, specifically the cGMPs, were used by food manufacturers as a template or guidance to design their general sanitation and food safety systems to prevent the production of adulterated food and to protect the consumer. In addition, FDA used cGMPs as a measurement to determine whether a food may have been adulterated or manufactured under insanitary conditions that would render it unfit for consumption. This would include indication of whether it was prepared, packed or held under conditions where it could become contaminated with filth or rendered injurious to health. Table 1 provides an overview of the subparts of Part 110 with the subsections from the current C.F.R.
It is highly recommended that the leadership of food facilities review the revised and updated cGMPs as the language in certain sections has changed. The final rule has removed nonbinding language that indicated that the material was considered guidance, specifically where the word “should” was used. Some of the previously nonbinding provisions, such as education and training, are now binding.
Implementation of cGMPs: The Need for Training
As you review the revised cGMPs, you may also want to consider specific additional policies that your company may want to include in your GMPs. Some of these cross over into the realm of personnel safety, such as the use of hearing protection or the disallowing of devices such as iPods that can distract an employee from his or her surroundings. Another practice may disallow the use of cellphones in work areas or the use of cameras for security purposes unless specifically authorized by company policy. In addition, companies may have to clarify with their human resource personnel what restrictions or limitations can be placed on the use of service animals.
One of the new binding requirements is that employees receive documented training and education. The rationale for this is that FDA has identified an association between foodborne illness and lack of understanding of GMP fundamentals. The agency estimates that up to 33 percent of all GMP-related recalls are the result of inadequate training and education. Consequently, it is vital that employees receive documented training and education in food safety principles and cGMPs. This means that the training and education will require a document that, at a minimum, should include:
• A description of the material to be covered by the training (e.g., a title and brief statement of content)
• The date and time of the training
• The printed name and the signature of each trained employee
• The trainer’s name and qualifications (e.g., food safety/quality assurance managers and any certifications they have)
• An indication that the signers clearly understand that by signing the document, they understand and will comply with the information presented and that there can be disciplinary consequences for noncompliance up to and including termination
Finally, experience has shown that it is very important to know the languages that will be required for the training material. This means that in addition to the material being written in the language(s) spoken in the plant, the training should be conducted in that language for the benefit of the employee.
FDA has also included in the cGMPs explicit regulatory text to address allergen cross-contact. Allergen cross-contamination is still one of the leading causes of product recall and must be addressed in the food safety plan and training.
The new regulations, as they will be implemented over the next few years, will provide FDA with new and expanded authority to monitor and regulate the food industry. It is important that manufacturers understand these rules to ensure that their safety programs prevent foodborne illness and injuries, protect consumers and comply with applicable rules and regulations. It’s best to get ahead of the new requirements included in FSMA to minimize the impact of noncompliance.
Michael Cramer, CQA, is the senior director, food safety and quality assurance, for Ajinomoto Windsor.