f. Intentional adulteration. This proposed rulemaking is not intended to address "hazards that may be intentionally introduced, including by acts of terrorism" (section 418(b)(2) of the FD&C Act). FDA plans to address section 103 of FSMA regarding such hazards in a separate rulemaking in the future. FDA tentatively concludes that intentional hazards, which are not addressed in traditional HACCP or other food safety systems, likely will require different kinds of controls and would be best addressed in a separate rulemaking. However, FDA also recognizes that some kinds of intentional adulterants could be viewed as reasonably likely to occur, e.g., in animal foods concerning which there is a widely recognized risk of economically motivated adulteration in certain circumstances. An example of this kind of hazard is the addition of melamine to certain food products apparently to enhance perceived quality and/or protein content. The Agency requests comment on whether to include potential hazards that may be intentionally introduced for economic reasons. The Agency also requests comment on when an economically motivated adulterant can be considered reasonably likely to occur.
D. Preventive Controls and Hazard Analysis and Critical Control Points (HACCP) Systems
HACCP is a preventive strategy for food safety that involves a systematic approach to the identification and assessment of the risk (likelihood of occurrence and severity) of hazards from a particular food or food production process or practice and the control of those hazards. FDA tentatively concludes for several reasons that HACCP is the appropriate framework to reference in interpreting and implementing section 103 of FSMA. For a full discussion of HACCP and preventive controls systems comparisons, please see section II.C of the document for the proposed rule for the preventive controls for human food (78 FR 3646).
E. Animal Food Safety Incidents: Examples and Monitoring
1. Examples of Animal Food Safety Incidents
Historically, the Agency has focused on specific animal food safety issues as problems arise, typically after the distribution of the contaminated animal food. Examples include safety issues related to BSE, chronic wasting disease, mycotoxins (especially aflatoxin in animal food intended for lactating dairy cattle), dioxins, melamine, and microbial contamination in pet foods.
The massive pet food recall due to adulteration of pet food with melamine and cyanuric acid (chemicals called triazines) in 2007 is a prime example. The actions taken by two protein suppliers in China to intentionally adulterate wheat gluten and rice protein concentrate for economic reasons affected a large number of pet food facilities in the United States and created a nationwide problem by causing illness and death in many dogs and cats. The addition of melamine to wheat gluten and rice protein concentrate resulted in a high nitrogen reading during Kjeldahl testing, a test method used to estimate protein levels in foods. By adding the melamine, a non-protein source of nitrogen, the suppliers created a falsely high estimate of protein in their products. While melamine by itself is relatively non-toxic to mammals, the melamine used to adulterate the wheat gluten and rice protein concentrate in this incident had been combined with cyanuric acid, creating a mixture that became toxic. The presence of cyanuric acid with melamine resulted in a precipitation of crystals (melamine cyanurate) when mixed in a solution (Ref. 17). When the animals ingested the adulterated food, the mix of these two chemicals was absorbed into the blood stream and ultimately created an accumulation of crystals in the tubules of the animals' kidneys, leading to kidney disease and death in many animals.