The FDA has published another chapter of the slowly evolving saga of guidance for FSMA’s Preventive Controls Rule. Having published the first five chapters of the “Hazard Analysis and Risk-Based Preventive Controls for Human Food: Guidance for Industry” in 2016, FDA has been rolling out the remaining guidance bit by bit, with six of the 17 chapters still awaiting publication. So, given the 10 years between the rule and the guidance, what is FDA recommending in Chapter 12: Control of Chemical Hazards?
The essential message of the guidance is that each facility must conduct hazard analyses to determine the chemical hazards that exist for their specific ingredients, products, processes, and supply chains, then determine whether these can be managed through CGMPs or if risk-based preventive controls are needed. It is then critical to implement appropriate practices to control these, monitor their operation, verify effectiveness, take corrective action, and maintain records.
It is also important to extend the hazard analyses beyond the plant to determine the potential for ingredient or supplier contamination, with particular focus on the potential for economically motivated adulteration and emerging chemical hazards. As such, the guidance emphasizes the verification of supply-chain preventive controls for chemical hazards that are controlled before the ingredients reach the manufacturing facility. Supplier verification programs are particularly relevant to chemical elements in agricultural ingredients, which may not be effectively removed through ordinary food processing. Thus, knowing where ingredients originate and how suppliers control contamination is as important to control as are the processes in the facility.
To assist in the analyses, the guidance categorizes known or reasonably foreseeable (“potential”) chemical hazards that could be present in raw materials or ingredients or form during food production as:
- Environmental contaminants: Arsenic, cadmium, lead, dioxins, perchlorates, PFAS, and radionuclides
- Natural toxins: Aflatoxins, deoxynivalenol (DON), hypoglycin A
- Agricultural chemicals: Unlawful pesticide residues
- Veterinary drugs: Drug residues in milk, honey, and other animal-derived foods
- Unauthorized additives: Food or color additives used outside authorized conditions
- Economically motivated adulteration: Lead chromate in spices, melamine in milk, Sudan I in chili powder
- Process-related contaminants: Acrylamide, 3-MCPD and its esters, glycidyl esters, and 4-methylimidazole
- Facility-related chemicals: Cleaning chemicals and other chemicals used in the facility
While not every potential hazard will require a preventive control, the determination as to whether CGMPs adequately manage a hazard or if a preventive control is needed should include consideration of the nature of the hazard, the food, the manufacturing process, available scientific evidence, and the effectiveness of existing controls. Key factors to consider are:
- The likelihood and severity of illness or injury.
- The food’s history of contamination, recalls, or associated illness.
- Ingredient sources and supplier performance.
- Product formulation, equipment, handling, and processing conditions.
- Intended use and consumption by vulnerable populations.
- The impact of current control measures applied in production.
- Past control failures and testing results.
- Any actions taken to comply with other regulatory requirements or programs
- Whether formal monitoring, corrective actions, verification, and records would improve control.
If it is then determined that a preventive control is not required, the reasoning behind this must be documented.
The guidance also includes a strong emphasis on foods for babies and young children “because their smaller body sizes and metabolism make them more vulnerable to the harmful effects of these contaminants.” As an example, for these foods, it is recommended that toxic elements (e.g., lead, inorganic arsenic, and cadmium) in ingredients be identified as hazards requiring a supply-chain program as a preventive control, rather than being managed through CGMPs alone. The guidance specifically cites FDA’s Closer to Zero action levels and initiatives, but also notes that where established levels don’t exist, FDA will assess contamination on a case-by-case basis considering the intended consumer as well as other factors.
Emphasizing the need for a proactive, science-based approach to chemical hazards, with consideration of both current and emerging hazards, FDA recommends that the industry stay updated on new information about current and emerging chemical contaminants. The guidance also highlights the importance of reviewing the hazard analyses regularly to ensure it remains current and effective.
Historically, the regulated food industry has focused on microbiological risks. This is for a good reason because outbreaks of microbiologically related illness are easy to spot and are increasingly easier to connect to a food, or to a food manufacturer or grower, through the use of whole genome sequencing. Several years ago, there was a move to focus on certain chemicals such as heavy metals, acrylamide, and PFAS – to name just a few. Today, the FDA is making it very clear that the food industry has to look much more broadly at chemical risks, and to both assess those risks and manage them. This will invoke the need to have new skills to understand chemical risks – something that many food companies do not have.
TAG’s experts have in-depth experience with hazard analyses and chemical controls both within the food facility and along the supply chain. We can help you interpret and apply the guidance to your processes.
In summary, the FDA has published chapter 12 of FSMA’s Preventive Controls Rule. The essential message of the guidance is that each facility must conduct hazard analyses to determine the chemical hazards that exist for their specific ingredients, products, processes, and supply chains, then determine whether these can be managed through CGMPs or if risk-based preventive controls are needed. To assist in the analyses, the guidance categorizes known or reasonably foreseeable (“potential”) chemical hazards that could be present in raw materials or ingredients or form during food production. While not every potential hazard will require a preventive control, the determination as to whether CGMPs adequately manage a hazard or if a preventive control is needed should include consideration of the nature of the hazard, the food, the manufacturing process, available scientific evidence, and the effectiveness of existing controls. Emphasizing the need for a proactive, science-based approach to chemical hazards, with consideration of both current and emerging hazards, FDA recommends that the industry stay updated on new information about current and emerging chemical contaminants.
