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For the last couple weeks, TAG has delved into the opening chapters of FDA’s draft guidance for the Preventive Controls rule. This week, we provide a discussion of Chapter 3, Potential Hazards, which is intended to help facilities consider common biological, chemical, and physical hazards that should be addressed in a hazard analysis in relation to ingredients, processes, and the facility, considering the issues and factors listed in chapter 2 (as discussed in TAG’s Sept. 22 newsletter). In most cases, the chapter provides an overview of the hazards with brief descriptions of potential preventive controls, then refers facilities to Chapter 4, Preventive Controls, and other as-yet unpublished chapters for detailed discussion of applicable controls. In the following we provide overviews of the guidance on biological, chemical, and physical hazards. (For lists of specific examples of each, see Table 3-1 on pages 39-41 of the guidance.) Biological Hazards This includes microbiological hazards, including bacteria, protozoa and parasites, and viruses. However, because FDA sees viruses and protozoa/parasites as able to be addressed by GMPs, the chapter focuses on bacterial pathogens, such as Salmonella spp., Listeria monocytogenes, Clostridium botulinum, and Shiga-toxin producing Escherichia coli(STEC) such as O157:H7, that may be associated with foods or food processing operations and can cause consumer illness or disease. Such biological hazards may be related to ingredients, processes, the facility, or people/handling and may be sporeformers or non-sporeformers (i.e., existing only as vegetative cells). Spores are not considered to be hazardous as long as they remain in the spore state. However, they are very resistant to heat, chemicals, and other treatments that would normally kill vegetative cells, so when spores are a concern, more intense processes are often needed. Additionally, as the Guidance explains, when spores survive a processing step designed to kill vegetative bacteria, they may become a hazard in the food if they are exposed to conditions that allow germination and growth. Thus, other controls such as reduced pH or water activity (aw) or temperature control may be needed. Because the characteristics of pathogens differ, the appropriate preventive controls may vary and need to be based on the characteristics of the specific pathogen(s) identified as a hazard. In the chapter, FDA and provides a quick reference guide of common sources of biological hazards and reviews characteristics of common pathogens (pages 43-46). Following this is discussion of each of the potential biological hazard sources: Ingredients – For this it refers facilities to tables in the chapter and appendices (which are voluminous) to help in the identification of hazards associated with specific food products, and to chapter 4 for control recommendations. Processess – The guidance discusses biological hazards that can occur if something goes wrong with a process control – such as bacterial pathogens that survive after treatment; that grow and/or produce toxin due to lack of proper time/temperature control, lack of proper coolinghese can include post-process contamination due to the poor implementation of CGMPs, su after heat treatments, poor formulation control, or reduced oxygen packaging (ROP); that are in ingredients added after process controls or introduced after packaging due to lack of container integrity. FDA then generally refers facilities to other chapters for more information and discussion of controls of each. Facility – Tch as exposure or contact with contaminated equipment during processing, holding, or packaging. This is typically caused by foods being exposed to the environment and recontaminated after the kill step. A table of examples is provided, along with information to help facilities determine if an environmental pathogen is a hazard requiring a preventive control, discussion of transient vs. resident contamination, and wet and dry processing environments. Chemical (including radiological) Hazards This includes pesticide residues, heavy metals, drug residues/veterinary antibiotics, industrial chemicals, environmental contaminants, mycotoxins, allergens, unapproved colors/additives, food intolerance/disorder substances [e.g., gluten], and radionuclides. Some ingredient-related chemical hazards are natural components of food (e.g., allergens) or are produced in the natural environment (e.g., mycotoxins), while others are contaminants of raw materials and other ingredients (e.g., pesticides, drug residues, heavy metals, environmental contaminants). Further in the guidance, FDA discusses each of these in depth. Some process-related chemical hazards may be included in product formulation (e.g., sulfites), others may be unintentionally introduced into food (e.g., industrial chemicals). The guidance again refers facilities to Chapter 4 for control information, then discusses characteristics of some chemical hazards and ways they can be introduced into a food product. In relation to chemical hazards, the guidance also notes that facilities must identify known or reasonably foreseeable hazards that may be intentionally introduced for purposes of economic gain. FDA recommends a focus on circumstances where there has been a pattern of such adulteration in the past, even if the past occurrences was not associated with any supplier or product of the facility. To determine if it is a hazard requiring a preventive control, the analysis should consider the country of origin and the specific supplier(s). It then includes a quick reference guide and referral to other sources of information. The section also provides a general overview of the “Big 8” food allergens and common causes of undeclared food allergen hazards, including incorrect label design, incorrect application or use of a label, and cross-contact; and discusses requirements for additives/colors and GRAS substances as well as unapproved additives/colors, potential hazards of misformulation, incorrect labeling of food intolerance/disorder substances, and the several contaminants produced during heating that may be a health concern. It then refers the facility to Chapter 11 and other resources. Noting that radiological hazards can become incorporated into food through the use of water that contains radionuclides, the guidance states that facilities should be aware of the condition of the water it uses and not use that which poses a hazard. Physical Hazards Including items such as metal, glass, plastic, wood and stones, physical hazards are broadly classified as “hard/sharp” or “choking” hazards which can cause consumer injury. They can occur throughout the facility, as well as in/with ingredients and supplies. The guidance discusses metal, glass and hard plastic as the most common physical hazards, noting that, for physical hazards, there often is overlap between those related to the facility and processes. For example, equipment that has food-contact surfaces that break during processing and result in physical debris being deposited in the food product can be considered a facility-related physical hazard (because the equipment is part of the facility) or a process-related physical hazard (because the equipment broke during processing). Thus, physical hazards can be evaluated as facility-related or process-related, although some will be readily classified to one or the other, such as nuts and bolts used in maintenance would be a facility-related hazard, but nuts and bolts that could fall out during production would be process-related. The chapter includes a quick reference table of common sources of some physical hazards. In summary, as we work through these guidance documents, we’re seeing that the FDA is certainly trying to provide us with an idea of what they expect.  I don’t think there are a lot of surprises in the main documents, but there have been a couple of items in Appendix 1 that have caused me some concern in relation to pathogens that need to be considered for certain goods. So FDA is certainly setting expectations, and these guidance documents are going to need to be read more than once to get them all figured out. About The Acheson Group (TAG) Led by Former FDA Associate Commissioner for Foods Dr. David Acheson, TAG is a food safety consulting group that provides guidance and expertise worldwide for companies throughout the food supply chain. With in-depth industry knowledge combined with real-world experience, TAG’s team of food safety experts help companies more effectively mitigate risk, improve operational efficiencies, and ensure regulatory and standards compliance. www.AchesonGroup.com

PC Guidance How To #3: Identifying Potential Hazards