2018-01296: Considerations for Determining Whether a Measure Provides the Same Level of Public Health Protection as the Corresponding Requirement in 21 CFR Part 112 or the Preventive Controls Requirements in Part 117 or 507; Draft Guidance for Industry; Availability

Summary

The Food and Drug Administration (FDA, we, or Agency) is announcing the availability of a draft guidance for industry entitled "Considerations for Determining Whether a Measure Provides the Same Level of Public Health Protection as the Corresponding Requirement in 21 CFR 112 or the Preventive Controls Requirements in Part 117 or 507." The draft guidance describes FDA's current thinking on the concept of "same level of public health protection" (SLPHP), and FDA's expectations for how an SLPHP evaluation should be conducted and an SLPHP determination should be reached. The draft guidance identifies certain points to consider that a competent authority, a farm, a facility, an importer, or other relevant entity should take into consideration when evaluating whether a measure that is different from that required under (part 112) 21 CFR part 112 or the preventive controls requirements in (part 117 or part 507) 21 CFR part 117 or 507 meets the SLPHP threshold under the foreign supplier verification program (FSVP) regulation (21 CFR part 1, subpart L) or under part 112.

The agency’s own summary, as published.

What this changes

Amends 4 parts of the Code of Federal Regulations — the standing rules this notice rewrites.

• 21 CFR 1 General Enforcement Regulations
• 21 CFR 112 Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption
• 21 CFR 117 Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food
• 21 CFR 507 Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals