The new FDA Rule revamping cGMPs and implementing new rules referred to as HARPC will impact the food industry greatly. In this second in a three-part series (read part one), we will discuss the FDA’s changes to cGMPs, noting the changes from the old version to the new, updated regulations.
cGMPs before the new Rule
In 1986, the U.S. Food and Drug Administration created and updated a series of good manufacturing practices rules (cGMPs) for domestic food manufacturers and foreign food manufacturers that import their products to the U.S. Over the last 29 years, the U.S. food industry has experienced significant change, ranging from the sources and content of foods to methods of manufacture and processing. Despite this shift, very little significant change in the cGMPs occurred, and therefore these regulations lagged behind the industry. With the passage of the Food Safety and Modernization Act (FSMA), the FDA has created a new and updated set of cGMPs in conjunction with the new Hazard Analysis and Risk-Based Preventative Controls (HARPC) program to correct this lag.
The new cGMPs: Goal is a safe food supply
The new cGMP regulations will be moved from 21 C.F.R. Part 110 et seq. to the first half of 21 C.F.R. Part 117. The second half of part 117 is dedicated to the HARPC sections. As part of the transition, some of the cGMP sections will be amended to take into account the new HARPC language and requirements. The following is a summary of the most important changes to the cGMPs by their new sections, with references to the current Part 110 citations in parentheses:
- 21 C.F.R. § 117.3 (21 C.F.R. § 110.3): Definitions
The Definitions section of the new cGMPs has added several important definitions that play an important part in the new regulations and HARPC requirements.
- Environmental Pathogen, Food Allergen, Cross-contact: These new definitions reflect parts of the HARPC regulations that require food manufacturers to identify the most common risk factors to the products they produce or process.
- Hazard, Hazard Reasonably Likely to Occur, Reasonably Foreseeable Hazard: As part of the HARPC system introduced in the new Rule, food industry members are tasked with analyzing their facilities and processes, then identifying those hazards that, depending on the food products being processed at that facility and the processes being applied, need to be addressed in the HARPC plan. This anticipates a critical analysis focused on those points in the process where food safety is at risk.
- Facility, Holding, Manufacturing/Processing, Mixed-type Facility, Packaging, Packing: The HARPC program, like the HACCP plans before it, are context and risk-based. That is, they focus on those hazards that are relevant to the product being processed safely and the procedures being used in a particular facility designed to ensure a safe food supply. The new cGMPs now include specific definitions of the locations and processes that HARPC plans are to cover.
- Monitor, Preventative Controls, Significantly Minimize, Verification: In addition to identifying risks and hazards relevant to the products and processes used in a facility, the new cGMPs and HARPC requirements also anticipate a specific set of steps that industry members have to undertake to minimize those risks. These new definitions help to clarify these steps.
- 21 C.F.R. § 117.10-§ 117.35 (21 C.F.R. § 110.10-110.35): Cross-Contact
- Section 117.10 remains largely unchanged but for several references to cross-contact. Cross-contact is defined as the unintentional introduction of an allergen into a food. This reference is added in several places, and emphasizes the FDA’s increased emphasis on protecting American consumers from accidental exposure to undisclosed allergens in their food. This is a theme that continues throughout the new cGMP sections and the HARPC program.
- Subsection 117.35(e) deals with sanitary facilities and controls and includes a new requirement that facility operators are to maintain non-food-contact surfaces so as to prevent cross-contact contamination. Subsection 117.37(e) simplifies the requirements for handwashing station availability. While the requirements are somewhat vague, they no longer can be read as optional, and instead “must” be met.
- 21 C.F.R. § 117.80 (21 C.F.R. § 110.80): Processes and controls
- The content of § 117.80 has been better organized into subsections that emphasize reducing the chances of cross-contact contamination.
- The new §117.80 has been fleshed out to increase its scope. For example, in the first section, the FDA specifically adds references to (in addition to manufacturing, processing, packing and holding of food products) the receiving, inspecting, transporting and segregating of food products and raw ingredients. While this is not new for FDA inspectors, as they have always considered these aspects of food processing during inspections, adding these activities to the cGMPs emphasizes the FDA’s more rigorous approach to enforcement since the FSMA. Food industry members that may be involved only in the handling of finished goods or raw materials will now also be more specifically encompassed by food cGMPs than ever before.
- 21 C.F.R § 117.110 (21 C.F.R. § 110.110): Defect Action Levels
- This section discusses the levels of naturally occurring defects in certain foods. The old § 110.110 required the FDA to publish a list of maximum acceptable levels and make it available upon request. That subsection has been removed, leaving the rest of the section intact. Based on the proposed language, the FDA expects industry members to, despite these levels of acceptable natural contaminants, make every effort to remove the contaminants to the lowest level feasible, instead of simply aiming for removing enough to reduce the amounts below FDA maximums.
These changes to the FDA cGMPs may, individually, appear minor, but taken as a whole indicate a paradigm shift within the application of the Food, Drug and Cosmetics Act. Ever since the enactment of the Food Safety and Modernization Act in 2011, the FDA has significantly stepped up its inspections and enforcement actions nationwide. These amendments to the FDA regulations reflect these efforts, expand upon them, and impose new requirements on the industry. All entities involved in food production will now be required to review their processes and facilities, viewing their businesses through a lens of risk identification, analysis, and prevention, from receipt of raw materials (including the business agreements with suppliers) to the moment those products leave the facility doors (including the trucks they leave on and the sales agreements with customers).
These new cGMPs feed directly into the new HARPC policies and reflect their priorities. Please look for our next article which will discuss what a HARPC plan is, and what industry members need to know as they plan to implement them.
At Thompson Coburn we have a team of attorneys in place that is experienced in handling not just the current cGMPs, but the HACCP plans that predate them and upon which the new requirements are largely based. If you have any questions or would like assistance with reviewing your company for compliance, please contact Diane Romza-Kutz.
Diane Romza-Kutz is a partner in Thompson Coburn's Health Law Practice Group.