4. Process and Controls (Subpart E) — This section of CGMPs addresses general sanitation and controls necessary to ensure that food is suitable for human consumption. It addresses the monitoring of physical factors (critical control points or CCPs), such as time, temperature, humidity, pH, flow rate, and acidification. Warehouse and distribution requirements are also included, requiring finished foods to be stored and distributed under conditions that protect against physical, chemical and microbial contamination. The container must also be protected from deterioration. This section also outlines very general requirements for warehousing and distribution. 5. Defect Action Levels (Subpart G) — The last part of the food CGMPs allows the FDA to define maximum defect action levels (DALs) for a defect that is natural or unavoidable even when foods are produced under CGMPs (as covered in the sections above). These defects are not hazardous to health at low levels and include rodent filth, insects or mold. Those exceeding maximum DALs will be considered in violation. FSMA and CGMPs. The Food Safety and Modernization Act (FSMA) of 2011 contains new provisions in Section 103 requiring hazard analysis and risk-based preventive controls. The provisions would require facilities to maintain a written food safety plan that would identify hazards, specify the steps that would put in place to minimize or prevent those hazards, identify monitoring procedures and record monitoring results, and specify what actions would be taken to correct the problems that arise. (6) What constitutes a hazard? Biological hazards — The Centers for Disease Control (CDC) lists four levels of biohazards. Level One: Bacteria and other microorganisms that are transmitted from one person to another via contact or through the air, e.g., Escherichia Coli and Bacilius subtilis. Level Two: Viruses and more severe bacteria, e.g., measles, influenza, and salmonella poisoning. Level Three: Strains and species of viruses that are more harmful to humans and could lead to death, e.g., Typhus and West Nile virus. Level Four: The most severe known and are often fatal, e.g., Ebola virus and Marburg virus. (7) Physical hazards — Any extraneous object or foreign matter in a food item which may cause illness or injury to a person consuming the product. These foreign objects include, but are not limited to bone or bone chips, metal flakes or fragments, injection needles, BB’s or shotgun pellets, pieces of product packaging, stones, glass or wood fragments, insects or other filth, personal items, or any other foreign material not normally found in food products. Sources for such contaminants include raw materials, badly maintained facilities and equipment, improper production procedures and poor employee practices. (8) Chemical hazards — There are two primary categories of chemical hazards: prohibited substances and unavoidable poisonous or deleterious substances. None of the prohibited substances should be in food ingredients or supplies. The FDA has tolerance levels for unavoidable chemical hazards such as pesticides, herbicides, growth hormones and antibiotics, additives and processing aids, lubricants, paints, cleaners and sanitizers. (9) Allergens are also considered with chemical hazards. The top eight food allergens include milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, soybeans. (10) 3
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