Chapter 3: What Potential Food Ingredient Hazards Occur in Human Food
3.2 Defining a Hazard and Its Significance in Food Manufacturing
Adulterated food associated with food manufacturing is caused by hazards. The FDA’s hazard analysis and preventive controls regulations define a “hazard” in 21 CFR Part 117.3 as “any biological, chemical (including radiological), or physical agent that has the poten- tial to cause illness or injury.” The FDA further defines a “hazard requiring a preventive control” as “a known or reasonably foreseeable hazard for which a person knowledgeable about the safe manufacturing, processing, packing, or holding of food would, based on the outcome of a hazard analysis (which includes an assessment of the severity of the illness or injury if the hazard were to occur and the probability that the hazard will occur in the absence of preventive controls), establish one or more preventive controls to significantly minimize or prevent the hazard in a food and components to manage those controls (such as monitoring, corrections or corrective actions, verification, and records) as appropriate to the food, the facility, and the nature of the preventive control and its role in the facility’s food safety system” (Food and Drug Administration, 2015c).
Hazards can adulterate food anywhere in the supply chain, but the most common adulteration occurs or is established and then becomes a hazard (e.g., toxin production in food after bacterial growth) during manufacturing of the food in a food facility.
Most hazards in foods are discovered after they have caused illness or injury. Oftentimes, their association is discovered only after a foodborne disease outbreak investigation led by the Centers for Disease Control and Prevention (CDC). Many of the specific biological, chemical, and physical hazards are well known due to their historic association with foodborne disease illnesses, injuries, and deaths (Table 3.1).
From the most recent (at the publication time of this book) surveillance data reported by the CDC, only “unknown hazards” come close to biological hazards in causing the most foodborne
What Potential Food Ingredient Hazards Occur in Human Food Manufacturing? 37 Table 3.1: Examples of hazards found during food manufacturing.
Hazard Category Hazard Subcategory Examples
Biological Bacteria Bacillus cereus
Campylobacter jejuni Clostridium botulinum Clostridium perfringens Shiga toxin-producing Escherichia coli
such as E. coli O157:H7 Listeria monocytogenes
Salmonella spp.
Shigella spp.
Staphylococcus aureus Biological Protozoa and parasites Cryptosporidium parvum
Cyclospora cayetanensis Giardia lamblia (Giardia intestinalis)
Trichinella spiralis
Biological Viruses Norovirus
Hepatitis A Rotavirus
Chemical Pesticide residues Organophosphates
Carbamates Chlorinated hydrocarbons
Pyrethroids
Chemical Heavy metals Lead
Arsenic Cadmium
Mercury
Chemical Drug residues
(veterinary antibiotics)
Chloramphenicol Beta-lactams
Chemical Industrial chemicals Ammonia
Chemical Environmental
contaminants
Dioxins
Chemical Mycotoxins Aflatoxin
Patulin Ochratoxin
Fumonisin Deoxynivalenol
Continued
Hazard Category Hazard Subcategory Examples
Chemical Allergens Milk, eggs, fish, crustacean shellfish,
tree nuts, peanuts, wheat, and soybeans (commonly called “the Big 8”) Chemical Unapproved colors
and additives
Red #4 Melamine Chemical Substances associated
with a food intolerance or food disorder
Lactose Yellow #5
Sulfites Carmine and cochineal
Gluten
Chemical Radionuclides Radium 226 and 228
Uranium 235 and 238 Strontium 90
Cesium 137 Iodine 131
Physical N/A Metal
Glass Hard plastic
Adapted from Food and Drug Administration, 2016. Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food. Appendix 1. https://www.fda.gov/downloads/Food/GuidanceRegulation/FSMA/UCM517402.pdf.
Table 3.1: Examples of hazards found during food manufacturing.—cont’d
disease outbreaks in the United States (Table 3.2). Thus, biological hazards seem to be the most probable hazards to adulterate food (Fig. 3.1). One could argue, however, that because allergy- related injury or deaths are not routinely monitored via surveillance and reported by the CDC (something that the authors believe should be initiated, especially in light of the large number of product and ingredient recalls that occur annually due to undeclared allergens), the number of chemical (allergens) hazard–associated outbreaks may be larger.
Table 3.2: Biological adulterations cause the most reported foodborne disease outbreaks.
Hazards Outbreaks
Biological 2545
Chemical 163
Physical Not measured
Unknown 1204
Adapted from CDC Surveillance of Foodborne Disease Outbreaks in the United States Annual Reports in 2009–2013.
What Potential Food Ingredient Hazards Occur in Human Food Manufacturing? 39
Single-state foodborne disease outbreaks, many of which are due to operational defects in single retail food service and sales establishments, are much more common than those that occur across state lines (Centers for Disease Control and Prevention, 2015a). However, 91% of multistate foodborne disease outbreaks are associated with just three foodborne bacterial pathogen hazards (Fig. 3.1), and the outbreaks they cause are the most lethal, according to the CDC.
Nevertheless, the focus should be on all hazards and how best to prevent them, regardless of the place where the hazard is introduced into the food. Some hazards are best pre- vented at retail food sales and service establishments (e.g., receiving processed raw poultry at retail and handling and cooking it to eliminate Campylobacter bacteria). Other hazards may be best managed via other food safety management principles established for food retail businesses (King, 2013). The best place to start is to define the source of the hazards associated with ingredients and foods by identifying food ingredient–
hazard pairs.
Most human food ingredients in their raw (not processed) state have some level of biological, chemical, or physical hazard associated with them due to the nature of their development (e.g.,
Figure 3.1
Example of bacterial hazards and their impact due to multistate foodborne disease outbreaks. From Centers for Disease Control and Prevention, 2015c. Safer Food Saves Lives Infographics. https://www.cdc.
gov/vitalsigns/foodsafety2015/infographic.html#graphic; CDC National Outbreak Report System, 1995–2014; CDC Vital Signs MMWR, November 2015.
exposed to the unprotected environment). Many hazards associated with specific foods are well known due to the numbers of foodborne disease outbreaks they cause and the severity of disease that results. Some hazards are common across many different types of ingredients, while several ingredients are associated with multiple types of hazards that must be prevented. For example, Salmonella spp. can be found as a contaminant on raw nuts, produce, and poultry (Table 3.3), whereas raw nuts, produce, and poultry can also each have chemical (pesticides, heavy metals, dioxins, Table 3.4) and physical hazards (bones, farm field debris, shell fragments; Table 3.5) associated with them. Of course, not every possible hazard that can be associated with an ingredient is probable, and thus each ingredient–hazard pair must also be evaluated for the probability of its presence in the ingredient via a hazard analysis (see Chapter 5).