5. Facility-Based Nature of the Written Food Safety Plan
The overall framework of section 418 of the FD&C Act is directed to a facility rather than, for example, a corporate entity that may have multiple facilities. For example, under section 418(b) of the FD&C Act the owner, operator, or agent in charge of a facility must identify and evaluate known or reasonably foreseeable hazards that may be associated with the facility (emphasis added). Thus, proposed SEC 507.30 establishes a requirement for every animal food facility to have its own written food safety plan.
Federal HACCP regulations for seafood juice, meat and poultry allow the HACCP plan to group food types or production method types if hazards, critical control points, critical limits, and required procedures such as monitoring, are essentially identical ( SEC 123.6(b)(2), SEC 120.8(a)(2), and 9 CFR 417.2(b)(2) respectively.) However, these do provide that any required features of the plan that are unique to a specific product or production method be clearly delineated in the plan and observed in practice. This type of grouping would be allowed under proposed SEC 507.30, and thus would provide flexibility for facilities in the development of their food safety plans.
B. Proposed SEC 507.33--Hazard Analysis
1. Requirements of Section 418 of the FD&C Act
Section 418(b)(1) of the FD&C Act specifies, in relevant part, that the owner, operator, or agent in charge of a facility shall identify and evaluate known or reasonably foreseeable hazards that may be associated with the facility, including: (1) Biological, chemical, physical, and radiological hazards, natural toxins, pesticides, drug residues, decomposition, parasites, allergens, and unapproved food and color additives; and (2) hazards that occur naturally, or may be unintentionally introduced. Section 418(b)(3) of the FD&C Act specifies, in relevant part, that the owner, operator, or agent in charge of a facility shall develop a written analysis of the hazards.
As discussed in section II.C.2.f, proposed part 507 is not intended to address "hazards that may be intentionally introduced, including by acts of terrorism." Therefore, the Agency would not be implementing section 418(b)(2) of the FD&C Act in this proposed rule.
Section 418(c)(1) of the FD&C Act specifies that the owner, operator, or agent in charge of a facility shall identify and implement preventive controls, including at critical control points, if any, to provide assurances that hazards identified in the hazard analysis conducted under section 418(b)(1) of the FD&C Act will be significantly minimized or prevented. Section 418(c)(3) of the FD&C Act specifies that the food manufactured, processed, packed, or held by such facility will not be adulterated under section 402 of the FD&C Act, or misbranded under section 403(w) of the FD&C Act.
Section 403(w) of the FD&C Act addresses the labeling of major food allergens, as defined in 201(qq) of the FD&C Act. The misbranding provisions in section 403 of the FD&C Act, when read together with other provisions of the Food Allergen Labeling and Consumer Protection Act, appear to be intended for human food. Therefore, this proposed rule does not address section 403(w) misbranding.
Sections 418(c)(1) and (c)(3) of the FD&C Act, which will be discussed more fully in section X.C.2, are relevant to the discussion of proposed SEC 507.33(a) regarding the purpose of the hazard analysis required by section 418(b) of the FD&C Act.
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