21 CFR Part 579
Animal feeds, Animal foods, Radiation protection.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, it is proposed that 21 CFR chapter I be amended as follows:
PART 16--REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION
1. The authority citation for 21 CFR part 16 continues to read as follows:
Authority: 15 U.S.C. 1451-1461; 21 U.S.C. 141-149, 321-394, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42 U.S.C. 201-262, 263b, 364.
2. In SEC 16.1, in paragraph (b)(2) add the following entry in numerical order to read as follows:
SEC 16.1 Scope.
* * * * *
(b) * * *
(2) * * *
SUBSEC 507.60 through 507.83 (part 507, subpart D) relating to withdrawal of exemption applicable to a qualified facility.
* * * * *
PART 225--CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS
3. The authority citation for 21 CFR part 225 continues to read as follows:
Authority: 21 U.S.C. 351, 352, 360b, 371, 374.
4. In SEC 225.1, add paragraph (d) to read as follows:
SEC 225.1 Current good manufacturing practice.
* * * * *
(d) In addition, non-medicated feed is subject to part 507 of this chapter.
5. The authority citation for 21 CFR part 500 continues to read as follows:
Authority: 21 U.S.C. 321, 331, 342, 343, 348, 351, 352, 353, 360b, 371, 379e.
6. Revise SEC 500.23 to read as follows:
SEC 500.23 Thermally processed low-acid foods packaged in hermetically sealed containers.
Except as provided in SEC 507.5(b), the provisions of parts 507 and 113 of this chapter apply to the manufacturing, processing, or packing of low-acid foods in hermetically sealed containers, and intended for use as food for animals.
7. Add part 507 to read as follows:
PART 507--CURRENT GOOD MANUFACTURING PRACTICE AND HAZARD ANALYSIS AND RISK-BASED PREVENTIVE CONTROLS FOR FOOD FOR ANIMALS
Subpart A--General Provisions
507.1 Applicability and status.
507.7 Requirements that apply to a qualified facility.
507.10 Applicability of subpart C to a facility solely engaged in the storage of packaged animal food that is not exposed to the environment.
Subpart B--Current Good Manufacturing Practice
507.17 Plant and grounds.
507.19 Sanitary operations.
507.20 Sanitary facilities and controls.
507.22 Equipment and utensils.
507.25 Processes and controls.
507.28 Warehousing and distribution.
Subpart C--Hazard Analysis and Risk-Based Preventive Controls
507.30 Requirement for a food safety plan.
507.33 Hazard analysis.
507.36 Preventive controls for hazards that are reasonably likely to occur.
507.38 Recall plan for animal food with a hazard that is reasonably likely to occur.
507.42 Corrective actions.
507.48 Modified requirements that apply to a facility solely engaged in the storage of packaged animal food that is not exposed to the environment.
507.50 Requirements applicable to a qualified individual.
507.55 Records required for this subpart C.
Subpart D--Withdrawal of an Exemption Applicable to a Qualified Facility
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