The written hazard analysis would include the justification for whatever conclusion the owner, operator, or agent in charge of a facility reaches, including a conclusion that no hazards are reasonably likely to occur. Thus, proposed SEC 507.33(a) would not limit the requirement for a written hazard analysis to those circumstances where the owner, operator, or agent in charge of a facility identifies one or more hazards that are reasonably likely to occur. Under proposed SEC 507.33(a), a written hazard analysis would be required even if the conclusion of the analysis is that there are no hazards reasonably likely to occur.
3. Proposed SEC 507.33(b)--Hazard Identification
Proposed SEC 507.33(b) would require that the hazard analysis consider hazards that may occur naturally or may be unintentionally introduced, including:
* Biological hazards, including microbiological hazards such as parasites, environmental pathogens, and other microorganisms of animal or human health significance (proposed SEC 507.33(b)(1));
* Chemical hazards, including substances such as pesticide and drug residues, natural toxins, decomposition, unapproved food or color additives, and nutrient imbalances (proposed SEC 507.33(b)(2));
* Physical hazards (proposed SEC 507.33(b)(3)); and
* Radiological hazards (proposed SEC 507.33(b)(4)).
Proposed SEC 507.33(b) would implement section 418(b)(1) of the FD&C Act and would establish four groups of hazards (i.e., biological, chemical, physical, and radiological).
Proposed SEC 507.33(b)(1) would include microbiological hazards within the category of biological hazards. Examples of microbiological hazards include:
* Parasites (which are required to be considered by section 418(b)(1)(A) of the FD&C Act). A parasite is an organism that lives on or in an organism of another species (often called the host organism) and receives its nutritional requirements from that other species. Cryptosporidium spp., Giardia intestinalis, and Toxoplasma gondii are examples of parasites.
* Environmental pathogens (e.g., Salmonella spp.); and
* Other microorganisms of animal or human health significance, including molds (e.g., Aspergillus spp., Penicillium spp., and Fusarium spp.) and bacteria (e.g., Salmonella spp., Clostridium spp.)
Proposed SEC 507.33(b)(2) would include substances such as pesticide and drug residues, natural toxins, decomposition, unapproved food or color additives, and nutrient imbalances (all of which except nutrient imbalances, are explicitly required to be considered by section 418(b)(1)(A) of the FD&C Act) within the category of chemical hazards. Pesticide residues may be present in animal food at levels in excess of a tolerance level established by the
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