Federal Register. Current Good Manufacturing Practice, Hazard Analysis, and Risk Based Preventive Controls for Human Food. Start Preamble. Start Printed Page 5. Handbook Of Garments Manufacturing Technology' title='Handbook Of Garments Manufacturing Technology' />AGENCY Food and Drug Administration, HHS. ACTION Final rule. P/370912557X.jpg' alt='Handbook Of Garments Manufacturing Technology' title='Handbook Of Garments Manufacturing Technology' />The textile and clothing industries provide the single source of growth in Bangladeshs rapidly developing economy. Exports of textiles and garments are the principal. REVIEWS Augmented Reality Application to Monitor Wireless Data Process in Manufacturing Operation Huda H. Dalef and Faieza Abdul Aziz J. Comput. Introduction, Purchasing Authority and Reporting Requirements. Department Introduction 2602 Statutory, Regulatory, Policy and Procedural Requirements. 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The bobbins are placed on a ribbon loom that. SUMMARY The Food and Drug Administration FDA or we is amending our regulation for Current Good Manufacturing Practice In Manufacturing, Packing, or Holding Human Food in two fundamental ways. First, we are modernizing the long standing current good manufacturing practice requirements. Second, we are adding requirements for domestic and foreign facilities that are subject to our regulation for Registration of Food Facilities to establish and implement hazard analysis and risk based preventive controls for human food. Audra Mcdonald Go Back Home Download'>Audra Mcdonald Go Back Home Download. We also are revising certain definitions in our regulation for Registration of Food Facilities to clarify the scope of the exemption from registration requirements provided for farms and, in so doing, to clarify which domestic and foreign facilities are subject to the requirements for hazard analysis and risk based preventive controls for human food. We are taking this action as part of our announced initiative to revisit the current good manufacturing practice requirements since they were last revised in 1. FDA Food Safety Modernization Act. The rule is intended to build a food safety system for the future that makes modern, science and risk based preventive controls the norm across all sectors of the food system. DATES This rule is effective November 1. September 1. 7, 2. FDA will publish a document in the Federal Register announcing the effective dates of paragraph 2 of the definition of qualified auditor in  1. See section LVI for the compliance dates. Start Further Info. FOR FURTHER INFORMATION CONTACT Jenny Scott, Center for Food Safety and Applied Nutrition HFS 3. Food and Drug Administration, 5. Paint Branch Pkwy., College Park, MD 2. End Further Info. End Preamble. Start Supplemental Information. SUPPLEMENTARY INFORMATION Table of Contents. Executive Summary. Purpose and Coverage of the Rule. Summary of the Major Provisions of the Rule. Costs and Benefits. I. Background. A. FDA Food Safety Modernization Act. B. Stages in the Rulemaking for the Human Preventive Controls Rule. C. Summary of the Major Provisions of Proposed Human Preventive Controls Rule. D. Draft Risk Assessment. E. Definition of Retail Food EstablishmentF. Public Comments. II. Legal Authority. A. Changes to Current 2. CFR Part 1, Subparts H, I, and JB. Changes to Current 2. CFR Part 1. 10. C. Hazard Analysis and Risk Based Preventive Controls. D. Comments on Legal Authority. III. General Comments on the Proposed Rule. IV. Comments on Proposed Revisions to the Definitions in the Section 4. Registration Regulations 2. CFR Part 1, Subpart H and the Section 4. Recordkeeping Regulations 2. CFR Part 1, Subpart JA. Definitions That Impact a Determination of Whether an Establishment Is a FarmB. Proposed Revisions to the Definition of Farm. C. Proposed New Definition of Harvesting. D. Proposed Revision to the Definition of Holding. E. Proposed Revision to the Definition of ManufacturingProcessing. F. Proposed New Definition of Mixed Type Facility. G. Proposed Revision to the Definition of Packing. V. Comments on the Organizing Principles for How the Status of a Food as a Raw Agricultural Commodity or as a Processed Food Affects the Requirements Applicable to a Farm Under Sections 4. FD C Act. VI. Rulemaking Required by Section 1. FSMA On Farm Activities. A. Section 1. 03c1C of FSMAB. Comments on Qualitative Risk Assessment of On Farm Activities Outside of the Farm Definition. C. Comments Regarding an Exemption for Small and Very Small Farm Mixed Type Facilities Under Section 4. FD C Act. VII. Comments on Proposed General Revisions to Current Part 1. Final Part 1. 17A. Title of Part 1. 17. B. Proposed Revisions for Consistency of Terms. C. Proposed Additions Regarding Allergen Cross Contact. D. Proposed Revisions for Consistency With the Definition of FoodE. Proposed Revisions To Address Guidance in Current Part 1. F. Proposed Editorial Changes. G. General Comments on Current Part 1. Final Part 1. 17VIII. Subpart A Comments on Proposed  1. Applicability and Status. A. Comments on Proposed  1. Applicability. B. Comments on Proposed  1. Prohibited Act. C. Comments on Proposed  1. Specific CGMP Requirements. IX. Subpart A Comments on Proposed  1. Definitions. A. Redesignation. B. Definitions in Current Part 1. That We Proposed To Delete. C. Definitions That We Proposed To Establish in Part 1. D. Comments Asking FDA To Establish Additional Definitions or Otherwise Clarify Terms Not Defined in the Rule. E. Additional Definitions To Clarify Terms Not Defined in the Proposed Rule. X. Subpart A Comments on Qualifications of Individuals Who Manufacture, Process, Pack, or Hold Food. A. Applicability and Qualifications of All Individuals Engaged in Manufacturing, Processing, Packing, or Holding Food Final  1. B. Additional Requirements Applicable to Supervisory Personnel Final  1. XI. Subpart A Comments on Proposed  1. Exemptions. A. General Comments on the Proposed Exemptions. B. Proposed  1. 17. Exemption Applicable to a Qualified Facility. C. Proposed  1. 17. Exemptions Applicable to Food Subject to HACCP Requirements for Fish and Fishery Products 2. CFR Part 1. 23 or for Juice 2. CFR Part 1. 20D. Proposed  1. Exemption Applicable to Food Subject to Part 1. Thermally Processed Low Acid Foods Packaged In Hermetically Sealed Containers. E. Proposed  1. 17. Exemption Applicable to a Facility That Manufactures, Processes, Packages, or Holds a Dietary Supplement. F. Proposed  1. 17. Exemption Applicable to Activities Subject to Standards for Produce Safety in Section 4. FD C Act. G. Proposed  1. Exemptions Applicable to On Farm Low Risk ActivityFood Combinations Conducted by a Small or Very Small Business. H. Proposed  1. 17. Exemption Related to Alcoholic Beverages. I. Proposed  1. 17. Exemption Applicable to Facilities Solely Engaged in Storage of Raw Agricultural Commodities Other Than Fruits and Start Printed Page 5. Vegetables Intended for Further Distribution or Processing. J. Proposed  1. 17. Exemption Applicable to Farms, Fishing Vessels, Activities of Farm Mixed Type Facilities Within the Definition of Farm, the Holding or Transportation of One or More Raw Agricultural Commodities, and Specified Activities Conducted on Specified Raw Agricultural Commodities. K. Comments Requesting Additional Exemptions. XII. Subpart A Comments on Proposed  1. Applicability of Part 1. Facility Solely Engaged in the Storage of Unexposed Packaged Food. XIII. Subpart B Comments on Proposed  1. Personnel. A. Management Responsibility for Requirements Applicable to Personnel. B. Proposed  1. 17. Disease Control. C. Proposed  1. 17. Cleanliness. Sennheiser Serial Numbers. XIV. Subpart B Comments on Proposed  1. Plant and Grounds. A. Proposed  1. 17. Grounds. B. Proposed  1. Plant Construction and Design. XV. Subpart B Comments on Proposed  1. Sanitary Operations. A. Proposed  1. 17. General Maintenance. B. Proposed  1. 17. Substances Used in Cleaning and Sanitizing Storage of Toxic Materials. C. Proposed  1. 17. Pest Control. D. Proposed  1. Sanitation of Food Contact Surfaces. E. Proposed  1. 17. Food Contact Surfaces Used for ManufacturingProcessing or Holding. F. Proposed  1. 17. Wet Cleaning. G. Proposed  1. Single Service Articles. H. Proposed  1. 17. Sanitation of Non Food Contact Surfaces. I. Proposed  1. 17.