Proposed SEC 507.3 defines "should," explaining that "should" is used to state recommended or advisory procedures or identify recommended equipment. "Should" denotes non-binding guidance. Consistent with the Agency's good guidance practices regulation (21 CFR 10.115), proposed provisions containing the word "should" are draft guidance at this stage. They do not create or confer any rights for or on any person and do not operate to bind
The Agency is proposing to define "significantly minimize" to mean to reduce to an acceptable level, including to eliminate. "Significantly minimize" and "preventive control" are terms used in FSMA and are consistent with the definition of "control measure" in the
The Agency is proposing to define the term "small business" to mean a business employing fewer than 500 persons. See section VIII.B.2 for additional discussion of small business.
The proposed limit of 500 employees would include all employees of the business rather than be limited to the employees at a particular facility.
The Agency is proposing to define the term "subsidiary," as it is defined in section 418(l)(4)(D) of the FD&C Act, to mean any company that is owned or controlled directly or indirectly by another company.
The Agency is proposing to define the term "validation" to mean that element of verification focused on collecting and evaluating scientific and technical information to determine whether the food safety plan, when properly implemented, will effectively control the identified hazards.
The Agency is proposing to define the term "verification" to mean those activities, other than monitoring, that establish the validity of the food safety plan and that the system is operating according to the plan. For further discussion on the use of the terms "validation" and "verification" in HACCP, see section X.B.4 of the document for the proposed rule for preventive controls for human food (78 FR 3646).
The Agency is proposing to define the term "very small business" to mean, for purposes of this proposed part 507, a business that has less than
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