We are pleased that Dr. Michael Fisher has joined the FTCLDF website as a regular contributor. Dr. Fisher is a retired United States Department of Agriculture (USDA) Food Safety and Inspection Services (FSIS) veterinarian, bringing decades of experience enforcing FSIS regulations during the slaughter and processing of animals for which the USDA provides inspection services. Dr. Fisher is thrilled to bring you his expertise and guidance to help you navigate regulatory compliance. His goal is for small, USDA-inspected meat processors to succeed and to understand how to best maintain compliance and reduce regulatory issues.
Generating a list of potential food safety hazards is easy. Invest an hour in Google or Wikipedia. Have a conversation with Siri or Alexa. But human beings, not computer algorithms, make determinations and lists of food safety hazards useless if you can’t determine which food safety hazards are reasonably likely to occur in your production process. Many lists exist, but let’s consider 9 Code of Federal Regulations (CFR) 417.2(a)(3), which is as close to a regulatory list of food safety hazards as exists.
9 CFR 417.2(a)(3) reads:
“Food safety hazards might be expected to arise from the following: (i) Natural toxins; (ii) Microbiological contamination; (iii) Chemical contamination; (iv) Pesticides; (v) Drug residues; (vi) Zoonotic diseases; (vii) Decomposition; (viii) Parasites; (ix) Unapproved use of direct or indirect food or color additives; and (x) Physical hazards.”
Natural toxins are chemical hazards and inherent constituents in some foods. Examples include cyanide-generating compounds in bamboo shoots and neurotoxins in certain shellfish, crustacean, and finfish. A literature search of AGRICOLA, the official database of the USDA National Agriculture Library, will find no references to the existence of natural toxins in raw meat of livestock or poultry origin because there are none.
Microbiological contamination is not a food safety hazard. Toxins produced by microorganisms contaminating foods are biological hazards and not inherent constituents of foods. Per FSIS [60 FR 49553], pathogenic microorganisms capable of producing toxins are reasonably likely to occur in products of livestock or poultry origin. Examples include Shiga toxin-producing E. coli and Listeria monocytogenes.
Chemicals, pesticides, and animal drugs are chemical hazards and not inherent constituents of foods. They are adjuncts in the food production system. FSIS’ National Residue Program for Meat, Poultry, and Egg Products, Fiscal Year Residue Sample Results since 2000 show that chemical, pesticide, and drug residues seldom occur with products of livestock or poultry origin.
Zoonotic disease is not a food safety hazard. Pathogenic organisms infesting live animals and transmitted to humans are biological hazards. According to the Centers for Disease Control and Prevention (CDC) National Center for Emerging and Zoonotic Infectious Diseases, the number of U.S. outbreaks of zoonotic disease attributed to livestock and poultry between 2007 and 2019 was zero.
Decomposition (i.e., spoilage) is not a food safety hazard. Decomposition is a chemical process whereby non-pathogenic microorganisms invade and break down a food. Decomposition makes a food unsuitable, not unsafe, for use as human food.
Parasites are biological hazards and not inherent constituents of foods. Pathogenic parasites transmitted to human beings in food products are zoonotic agents. According to the CDC’s Center for Global Health’s Division of Parasitic Diseases and Malaria, trichinellosis and taeniasis are the most common parasitic conditions associated with livestock or poultry worldwide. The U.S. incidence of trichinellosis and taeniasis attributed to livestock and poultry is near zero.
Direct or indirect food or color additives are chemical hazards and not inherent constituents of foods. Additives are ingredients added to meat and poultry products during preparation or adjuncts in the food production system. The Food and Drug Administration (FDA) regulates food and color additives. CDC’s National Outbreak Reporting System (NORS) reported the number of illnesses resulting in hospitalization caused by food or color additives between 2009 and 2018 as zero.
Physical objects are physical hazards if their size or shape can cause traumatic injury including laceration and perforation of tissues of the mouth, tongue, throat, stomach, and intestine or damage to the teeth and gums. Physical objects are not inherent constituents of foods. FDA’s Policy Compliance Guide Section 555.425 names hard, sharp objects ≥7 mm and ≤25 mm in food as capable of causing such injury. NORS reports zero traumatic injury due to physical objects in foods between 2009 and 2018.
All conditions listed in 9 CFR 417.2(a)(3) may adulterate a food. Adulterants that cause a food to be unsafe for use as human food are food safety hazards. A 9 CFR 417.2(a)(1) control (i.e., a 9 CFR 417.1 preventive measure) is required. Adulterants that cause a food to be unfit for use as human food are not food safety hazards. A 9 CFR 417.2(a)(1) control is not required; a good manufacturing practice or standard operating procedure is sufficient.
Over the last four months we have prepared to conduct a hazard analysis. Next month we will apply what we have learned and conduct a slaughter hazard analysis. Stay tuned.
As always, if you have a question, please use the Contact Us link and ask.
Did you miss Dr. Fisher’s previous posts?
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Services provided by FTCLDF go beyond legal representation for members in court cases.
Educational and policy work also provide an avenue for FTCLDF to build grassroots activism to create the most favorable regulatory climate possible. In addition to advising on bill language, FTCLDF supports favorable legislation via action alerts and social media outreach.