2016-26314: What You Need To Know About the Food and Drug Administration Regulation: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals; Small Entity Compliance Guide; Availability
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The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a guidance for industry #241 entitled "What You Need To Know About the FDA Regulation: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals"--Small Entity Compliance Guide. The small entity compliance guide (SECG) is intended to help small entities comply with the final rule titled "Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals."
The agency’s own summary, as published.
What this changes
Amends 1 part of the Code of Federal Regulations — the standing rules this notice rewrites.
Rulemaking docket
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Proposed Rule October 29, 2013Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals; Public Meeting on Proposed Rule
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Proposed Rule October 29, 2013Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals
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Supporting & Related Material October 29, 2013FDA Preliminary Regulatory Impact Analysis 2013, PRIA References, and Preamble References re Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals, FDA-2011-N-0...
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Other December 05, 2013OMB Executive Order 12866 Regulatory Planning and Review re Current Good Manufacturing Practice and Hazard Analysis and Risk Based Preventive Controls for Food for Animals Proposed Rule Publication Date October 29 2013
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Other December 31, 2013Request for Extension from American Feed Industry Association
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Proposed Rule February 03, 2014Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals; Extension of Comment Period
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Other September 24, 2014Comparison Redlined Version of the Codified Sections Published on October 29, 2013 and September 29, 2014
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Supporting & Related Material September 29, 2014Reference 8 - Grasser et al. Quantity and Economic Importance by-prouducts re Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals
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Supporting & Related Material September 29, 2014Reference 10 - FDA Memorandum, "Biological, Chemical, and Physical Hazards Associated With Human Food By-Products Used for Animal Food," 2014 re Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Prev...
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Supporting & Related Material September 29, 2014Refeence 7 - FDA Quality Risk Assessment Risk of Activity-Animal Food Combination for Activities Conducted in a Facility C0-Located on a Farm" 2013 re Current Good Manufacturing Practice and Hazard Analysis and Risk-Base...
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Supporting & Related Material September 29, 2014Reference 9 - FDA Compliance Program Guidance Manual Feed Contaminants re Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals
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Supporting & Related Material September 29, 2014Reference 11 - FDA Compliance Policy Guide Sec 675.100 Diversion of Contaminated Food for Animal Use re Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals
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Supporting & Related Material September 29, 2014Reference 6 - Stored Product Management Circular No E-912 re Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals
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Supporting & Related Material September 29, 2014Reference List re Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals
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Supporting & Related Material September 29, 2014Reference 2 - FDA, "Transcript: FSMA Proposed Rule on Preventive Controls for Animal Food (PCAF) Facilities Public Meeting, November 21, 2013." re Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Pr...
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Supporting & Related Material September 29, 2014Reference 5 - FDA, "Update on Proposed Rules under the FDA Food Safety Modernization Act (March 19, 2014)." re Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals
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Supporting & Related Material September 29, 2014Reference 1 - FSMA Supplemental Notice of Proposed Rulemaking for Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals. Preliminary Regulatory Impact Analysis,"...
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Proposed Rule September 29, 2014Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals
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Supporting & Related Material September 29, 2014Reference 12 - FDA Compliance Policy Guide Sec 675.200 Diversion of Adulterated Food to Acceptable Animal Feed Use re Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food fo...
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Supporting & Related Material September 29, 2014Reference 3 - FDA, "Transcript: FSMA Proposed Rule on Preventive Controls for Animal Food (PCAF) Facilities Public Meeting, November 25, 2013." re Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Pr...
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Supporting & Related Material September 29, 2014Reference 4 - FDA, "Transcript: FSMA Proposed Rule on Preventive Controls for Animal Food (PCAF) Facilities Public Meeting, December 6, 2013." re Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Pr...
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Supporting & Related Material September 30, 2014PRIA Reference 1 - 2013 FDA Preliminary Regulatory Impact Analysis re Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals
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Supporting & Related Material September 30, 2014Memo - Reference 46 - Feeding Corn Milling Co-Products to Feedlot Cattle 3rd Edition Nov 2010 re Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals
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Supporting & Related Material September 30, 2014Memo - Reference 11- Feeding Food Wastes to Swine re Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals
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Supporting & Related Material September 30, 2014Memo - Reference 14 - Citrinin as a Possible Cause of the Pruritis, Pyrexia, Haemorrhagic Syndrome in Cattle re Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals
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Supporting & Related Material September 30, 2014Reference 16 - FDA, "Compliance Policy Guide Sec. 665.100 Common or Usual Names for Animal Feed Ingredients" re Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Ani...
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Supporting & Related Material September 30, 2014Reference18 - Codex Alimentarius Commission, "General Principles of Food Hygiene, CAC/RCP 1-1969 (Rev. 4-2003)," 2003 re Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food...
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Supporting & Related Material September 30, 2014PRIA Reference - 3 Nationwide Survey of Food Industry Safety Practices 2011 re Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals
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Supporting & Related Material September 30, 2014Memo - Reference 13 - (english) Food Poisoning in Cattle Caused by Ingestion of Brewers’ Grains re Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals
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Supporting & Related Material September 30, 2014Memo - Reference 13-1 Food Poisoning in Cattle Caused by Ingestion of Brewers’ Grains re Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals
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Supporting & Related Material September 30, 2014Memo - Reference 33 - CDC Frequently Asked Questions (FAQ) about Radiation Emergencies re Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals
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Supporting & Related Material September 30, 2014Memo - Reference 39 Nuclear Radiological Incident Annex (NRIA) to the National Response Framework (NRF) June 2008 re Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for...
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Supporting & Related Material September 30, 2014Reference19 - U.S.Pharmacopeial Convention, "U.S. Pharmacopeial Convention (USP) Food Fraud Database," re Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals
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Supporting & Related Material September 30, 2014Reference 15 - British Standards Institute (BSI), "Publicly Available Specification (PAS) 222:2011 Prerequisite Programmes for Food Safety in the Manufacture of Food and Feed for Animals," 2011 re Current Good Manufactur...
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Supporting & Related Material September 30, 2014Reference List for Supp PRIA re Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals
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Supporting & Related Material September 30, 2014Memo - Reference 17 - Some major mycotoxins and their mycotoxicoses—An overview re Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals
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Supporting & Related Material September 30, 2014Memo - Reference 18 - By-Product Feeds for Alabama Beef Cattle re Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals
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Supporting & Related Material September 30, 2014Memo - Reference 26 - FDA Pesticide Monitoring Program - FY 2008 re Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals
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Supporting & Related Material September 30, 2014Memo - Reference 34 - Occurrence of Uranium and 222Radon in Glacial and Bedrock Aquifers re Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals
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Supporting & Related Material September 30, 2014Reference 23 - FDA, "Current Good Manufacturing Practice and Hazard Analysis and Risk-based Preventive Controls for Human Food--Preliminary Regulatory Impact Analysis," 2013 re Current Good Manufacturing Practice and Haz...
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Supporting & Related Material September 30, 2014Reference 22 - FDA, "Current Good Manufacturing Practice and Hazard Analysis and Risk-based Preventive Controls for Food for Animals--Preliminary Regulatory Impact Analysis," 2013 re Current Good Manufacturing Practice a...
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Supporting & Related Material September 30, 2014Memo - Reference 44 - Considerations for Using By-Product Feeds University of GA Cooperative Extension Bulletin 862 re Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food...
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Supporting & Related Material September 30, 2014Memo - Reference 45 - Alternative Feed Ingredients in Swine Diets II 2008 Pork Checkoff re Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals
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Supporting & Related Material September 30, 2014Memo - Reference 3 FDA Compliance Program Guidance Manual Feed Contaminants re Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals
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Supporting & Related Material September 30, 2014Memo - Reference 8 - Effects on poultry and livestock of feed contamination with bacteria and fungi re Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals
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Supporting & Related Material September 30, 2014Memo - Reference 21- Effect of light and temperature on the formation of glycoalkaloids in potato tubers re Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals
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Supporting & Related Material September 30, 2014Memo - Reference 35 - Occurrence of Selected Radionuclides in Ground Water used for Drinking Water 1998 Resources Investigations Report 00-4273 re Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Pr...
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Supporting & Related Material September 30, 2014Memo - Reference 1 - FDA Reportable Food Registry Annual Report re Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals
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Supporting & Related Material September 30, 2014Memo - Reference 19 - Brewing by-products, Their Use as Animal Feeds re Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals
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Supporting & Related Material September 30, 2014Memo - Reference 29 - FDA Pesticide Monitoring Program 2011 re Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals
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Supporting & Related Material September 30, 2014Reference 24 - FDA, "Re-proposal of Select Provisions of the Proposed Rule: Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals," 2014 re Current Good Manufactu...
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Supporting & Related Material September 30, 2014Reference 17 - Codex Alimentarius Commission Hazard Analysis and Critical Control Point (HACCP) System and Guidelines For Its Application re Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventi...
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Supporting & Related Material September 30, 2014Memo - Reference 25 - Feeding Sweet Potatoes to Beef Cattle re Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals
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Supporting & Related Material September 30, 2014Memo - Reference 28 - FDA Pesticide Monitoring Program 2010 re Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals
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Supporting & Related Material September 30, 2014Memo - Referemce 37-National Primary Drinking Water Radionuclides 40 CFR Parts 9, 141, and 142 December 7 2000 re Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for An...
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Supporting & Related Material September 30, 2014Memo - Reference 40 - CPG Sec. 560.750 Radionuclides in Imported Foods - Levels of Concern Updated 112905 re Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals
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Supporting & Related Material September 30, 2014Memo - Reference 22 - Glycoalkaloid and Calystegine Levels in Table Potato Cultivars re Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals
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Supporting & Related Material September 30, 2014Memo - Reference 23 - Feeding Potato Processing Wastes and Culls to Cattle re Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals
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Supporting & Related Material September 30, 2014Memo - Reference 24 - Potato by-product feeding in the Pacific Northwest re Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals
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Supporting & Related Material September 30, 2014Memo - Reference 32 - Biological Effects of Radiation re Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals
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Supporting & Related Material September 30, 2014Memo - Reference 2 - FDA Animal and Veterinary Recalls Archive re Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals
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Supporting & Related Material September 30, 2014Memo - Reference 7 - By-Product Feedstuffs in Dairy Cattle Diets in the Upper Midwest re Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals
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Supporting & Related Material September 30, 2014Memo - Reference 10 - Animal Feed Contamination re Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals
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Supporting & Related Material September 30, 2014Memo - Reference 15 - Aflatoxin contamination of consumer milk re Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals
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Supporting & Related Material September 30, 2014Memo - Reference 16 - Health and production aspects of feeding sweetpotatoes to cattle re Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals
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Supporting & Related Material September 30, 2014Memo - Reference 30 - FDA Pesticide Program Residue Monitoring Databases re Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals
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Supporting & Related Material September 30, 2014Reference 14 – Food and Agriculture Organization of the United Nations (FAO) and World Health Organization (WHO), "Good Practices for the Feed Industry--Implementing the Codex Alimentarius Code of Practice on Good Animal...
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Supporting & Related Material September 30, 2014PRIA Reference 2 - ERG final - Animal Feed Safety System April 2011 re Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals
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Supporting & Related Material September 30, 2014Reference List for By-Product Memo re Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals
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Supporting & Related Material September 30, 2014Memo - Reference 5 - Byproducts and unusual feedstuffs re Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals
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Supporting & Related Material September 30, 2014Memo - Reference 6 - Alternative Feeds for Beef Cattle re Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals
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Supporting & Related Material September 30, 2014Memo - Reference 20 - Mycobiota and mycotoxins in malted barley and brewer’s spent grain from Argentinean breweries re Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food f...
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Supporting & Related Material September 30, 2014Memo - Reference 38-Groundwater Ambient Monitoring and Assessment Draft Updated August 2013 re Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals
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Supporting & Related Material September 30, 2014Reference 13 - Association of American Feed Control Officials (AAFCO)- Model Good Manufacturing Practice Regulations for Feed and Feed Ingredients re Current Good Manufacturing Practice and Hazard Analysis and Risk-Based...
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Supporting & Related Material September 30, 2014PRIA Reference 4 - NPN Pricing Sample Document re Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals
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Supporting & Related Material September 30, 2014Memo - Reference 31- Pesticide Residues in Beef Tissues from Cattle re Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals
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Supporting & Related Material September 30, 2014Memo - Reference 41 - The Media Careen from Radiation in Japan to War in Libya PEJ News Coverage Index March 14-20, 2011 re Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for F...
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Supporting & Related Material September 30, 2014Reference 20 - Congressional Research Service, "Food Fraud and Economically Motivated Adulteration of Food and Food Ingredients" re Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Contro...
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Supporting & Related Material September 30, 2014Reference 21 -Muth, M. K., C. Zhen, M. Coglaiti, S. Karns, and C. Viator, "Food Processing Sector Study, Contract HHSF 22320101745G, Task Order 13, Final Report," 2011 re Current Good Manufacturing Practice and Hazard An...
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Supporting & Related Material September 30, 2014Memo - Reference 4 - The importance of by-products to the US beef industry re Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals
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Supporting & Related Material September 30, 2014Memo - Reference 9 - Investigation of Multistate Outbreak of Human Infections re Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals
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Supporting & Related Material September 30, 2014Memo - Reference 12 - Bacterial concentration reduction of food waste amended animal re Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals
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Supporting & Related Material September 30, 2014Memo - Reference 27 - FDA Pesticide Monitoring Program 2009 re Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals
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Supporting & Related Material September 30, 2014Memo - Reference 36-Humanitarian Health Action FAQs - Japan Nuclear Concerns September 2011 re Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals
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Supporting & Related Material September 30, 2014Memo - Reference 42 - Animal Welfare in Animal Agriculture CRC Press re Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals
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Supporting & Related Material September 30, 2014Memo - Reference 43 - Quantity and Economic Importance of Nine Selected By-Products L.A. Grasser et al reCurrent Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals
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Supporting & Related Material October 16, 2014Tab C Final Regulatory Action as Cleared by OIRA, and a Final Version of the Materials Required by the Executive Order (Supp NPRM) re OMB Executive Order 12866 Regulatory Planning and Review re Current Good Manufacturing...
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Supporting & Related Material October 16, 2014Tab A Draft Regulatory Action as Submitted to OMB (Supp PRIA) re OMB Executive Order 12866 Regulatory Planning and Review re Current Good Manufacturing Practice and Hazard Analysis and Risk Based Preventive Controls for ...
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Supporting & Related Material October 16, 2014Tab B Substantive Changes Between Draft for Review and Regulatory Action (Supp NPRM) re OMB Executive Order 12866 Regulatory Planning and Review re Current Good Manufacturing Practice and Hazard Analysis and Risk Based P...
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Supporting & Related Material October 16, 2014Tab B Substantive Changes Between Draft for Review and Regulatory Action (Supp PRIA) re OMB Executive Order 12866 Regulatory Planning and Review re Current Good Manufacturing Practice and Hazard Analysis and Risk Based P...
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Supporting & Related Material October 16, 2014Tab A Draft Regulatory Action as Submitted to OMB (Supp NPRM) re OMB Executive Order 12866 Regulatory Planning and Review re Current Good Manufacturing Practice and Hazard Analysis and Risk Based Preventive Controls for ...
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Other October 16, 2014OMB Executive Order 12866 Regulatory Planning and Review re Current Good Manufacturing Practice and Hazard Analysis and Risk Based Preventive Controls for Food for Animals (Supplemental Proposed Rule) Publication Date September 29, 2014
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Supporting & Related Material October 16, 2014Tab C Final Regulatory Action as Cleared by OIRA, and a Final Version of the Materials Required by the Executive Order (Supp PRIA) re OMB Executive Order 12866 Regulatory Planning and Review re Current Good Manufacturing...
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Proposed Rule October 23, 2014Food and Drug Administration Food Safety Modernization Act: Meetings on Rule Revisions
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Other November 20, 2014FDA Response Letter Denying Comment Period Extension Request November 17, 2014
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Other December 02, 2014Request for Extension from the Western Colorado Congress
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Other January 09, 2015Record of Outreach Session Between FDA/CFSAN and the National Cattlemen's Beef Association
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Other August 19, 2015Record of Outreach for FSMA Proposed Rule for Preventive Controls for Animal Food
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Other August 24, 2015Record of Outreach for FSMA Supplemental Rule for Preventive Controls for Animal Food
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Supporting & Related Material September 17, 2015Reference 2. FRIA - ERG final - Animal Feed Safety System April 2011 re Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals
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Supporting & Related Material September 17, 2015Reference 24 Solely at Dictionary.com re Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals
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Supporting & Related Material September 17, 2015Reference 37 Recall Natura Pet Vitamin Insufficiency re Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals
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Supporting & Related Material September 17, 2015Reference 50 FSIS Compliance Guideline HACCP Systems Validation re Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals
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Supporting & Related Material September 17, 2015Reference 58 GFSI Guidance Document Ver 63 re Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals
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Supporting & Related Material September 17, 2015Reference 16 FDA RFR Fourth Annual Report 9-8-12 to 9-7-13 re Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals
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Supporting & Related Material September 17, 2015Reference 18 Recall of JJ Fuds, Inc Pet Food re Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals
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Supporting & Related Material September 17, 2015Reference 60 FDA, Final Regulatory Impact Analyisis, 2015 re Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals
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Supporting & Related Material September 17, 2015Reference 9 FDA Operational Strategy for Implementing FSMA re Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals
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Supporting & Related Material September 17, 2015Reference 10 Inspection Modernization and Training for Implementing FSMA re Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals
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Supporting & Related Material September 17, 2015Reference 31 Recall P&G Cat Food Low Levels of Thiamine re Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals
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Supporting & Related Material September 17, 2015Reference 36 Recall Cargill Excessive Levels of Sodium Meatbird Feed re Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals
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Supporting & Related Material September 17, 2015Reference 38 Recall Primal Pet Foods Raw Frozen Cat Food Low Low Levels of Thiamine re Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals
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Supporting & Related Material September 17, 2015Reference 59 Information for Foreign Governments-FAQ Systems Recognition re Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals
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Supporting & Related Material September 17, 2015Reference 7. FRIA - Estimate of Foodborne proportion from Australia re Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals
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Supporting & Related Material September 17, 2015Reference 44 FDA E-mail Sign-up Page for Recalls re Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals
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Supporting & Related Material September 17, 2015Reference 54 Codex Alimentarius Procedural Manual, 23rd Edition re Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals
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Supporting & Related Material September 17, 2015Reference 57 Letter to Sunland Inc. Suspension of Registration re Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals
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Supporting & Related Material September 17, 2015Reference 10. FRIA - US ownership from APPA via Human Society 2012 re Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals
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Supporting & Related Material September 17, 2015Reference 11. FRIA - RTI Animal Feed ExpElic Final Report re Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals
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Supporting & Related Material September 17, 2015Reference 8 Partnership for Food Protection National Workplan Workgroup re Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals
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Supporting & Related Material September 17, 2015Reference 15 FDA RFR Third Annual Report 9-8-11 to 9-7-12 re Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals
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Supporting & Related Material September 17, 2015Reference 21 Food Processing Sector Study_final_August 2015 re Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals
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Supporting & Related Material September 17, 2015Reference 6. FRIA - Banfield State_of_Pet_Health_2012 re Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals
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Supporting & Related Material September 17, 2015Reference 35 Recall PGG_HSC Feed LLC High Copper Levels re Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals
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Supporting & Related Material September 17, 2015Reference 42 GFI Questions and Answers Regarding Mandatory Food Recalls re Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals
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Supporting & Related Material September 17, 2015Reference 47 Definition of Include by Merriam-Webster re Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals
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Supporting & Related Material September 17, 2015Reference 63 Tribal Summary Impact Statement Report for PCAF re Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals
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Supporting & Related Material September 17, 2015Reference 5 FDA, Education and Technical Assistance for Industry re Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals
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Supporting & Related Material September 17, 2015Reference 40 Analysis of thiamine in canned cat foods AVMA 2014 re Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals
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Supporting & Related Material September 17, 2015Reference 43 FDA Internet Home Page re Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals
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Supporting & Related Material September 17, 2015Reference 45 Guidance for Industry Product Recalls re Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals
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Supporting & Related Material September 17, 2015Reference 56 FDA Import Alerts Webpage re Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals
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Supporting & Related Material September 17, 2015Reference 19 Draft GFI Qs and As Reportable Food Registry re Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals
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Supporting & Related Material September 17, 2015Reference 39 Recall Ainsworth Pet Nutrition Wet Cat Food Elevated Vitamin D re Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals
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Supporting & Related Material September 17, 2015Reference 8. FRIA - Salmonella Infection in Dogs petmd re Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals
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Supporting & Related Material September 17, 2015Reference 64 FDA Memorandum, Environmental Reivew Final PCAF Rule re Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals
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Supporting & Related Material September 17, 2015Reference List for Final Rule for Preventive Controls for animal food re Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals
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Supporting & Related Material September 17, 2015Reference 4 Technical Staffing and Guidance Development at FDA re Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals
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Supporting & Related Material September 17, 2015Reference 6 Food safety preventive controls alliance re Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals
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Supporting & Related Material September 17, 2015Reference 55 FDA Warning Letters re Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals
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Supporting & Related Material September 17, 2015Reference 20 GFI Qs and As Reportable Food Registry re Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals
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Supporting & Related Material September 17, 2015Reference 30 USDA National Nutrient Database re Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals
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Rule September 17, 2015Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals
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Supporting & Related Material September 17, 2015Reference 9. FRIA - AVMA U.S. Pet Ownership Statistics 2012 re Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals
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Supporting & Related Material September 17, 2015Reference 14 FDA RFR Second Annual Report 9-8-10 to 9-7-11 re Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals
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Supporting & Related Material September 17, 2015Reference 23 GFI Food Facility Registration re Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals
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Supporting & Related Material September 17, 2015Reference 33 Recall of Mazuri and LabDiet Feed Products Elevated Vitamin D Level re Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals
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Supporting & Related Material September 17, 2015Reference 48 GFI Testing for Salmonella in Human Foods and Human-Contact Animal Foods re Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals
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Supporting & Related Material September 17, 2015Reference 62 WTO Agreement on Sanitary and Phytosanitary Measures re Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals
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Supporting & Related Material September 17, 2015Reference 4. FRIA - HHS RIA Guidance Coverpage Sept 2014 draft re Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals
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Supporting & Related Material September 17, 2015Reference 5. FRIA - BanfieldJournal Spring 2013 pediatric w age distn re Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals
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Supporting & Related Material September 17, 2015Reference 2 Record of Outreach for Supplemental Rule for PC Animal Food re Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals
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Supporting & Related Material September 17, 2015Reference 3 Final Risk Assessment PCAF re Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals
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Supporting & Related Material September 17, 2015Reference 1 Record of Outreach for Proposed Rule for PC Animal Food re Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals
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Supporting & Related Material September 17, 2015Reference 32 Recall Ridley Block Operations Beef Cattle Supplement Excess Urea re Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals
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Supporting & Related Material September 17, 2015Reference 34 Recall ADM Alliance Nutrition Lamb Feed Excess Coopper re Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals
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Supporting & Related Material September 17, 2015Reference 61 WTO Implementation-Related Issues and Concerns re Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals
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Supporting & Related Material September 17, 2015REFERENCE LIST for Final Regulatory Impact Analysis (FRIA) re Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals
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Supporting & Related Material September 17, 2015Reference 7 FDA Competitive Grant Program with NIFA re Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals
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Supporting & Related Material September 17, 2015Reference 17 Recall Bravo Pet Food for Dogs and Cats re Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals
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Supporting & Related Material September 17, 2015Reference 46 FDA, Animal and Veterinary Recalls & Withdrawals Web Page re Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals
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Supporting & Related Material September 22, 2015Reference 11. FRIA - RTI Animal Feed ExpElic Final Report re Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals
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Notice November 13, 2015Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals
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Rule January 22, 2016Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals; Technical Amendment
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Rule August 24, 2016The Food and Drug Administration Food Safety Modernization Act; Extension and Clarification of Compliance Dates for Certain Provisions of Four Implementing Rules
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Rule September 19, 2016Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food and Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals; Definition of Qualified ...
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Other November 01, 2016Guidance for Industry on What You Need to Know About the FDA Regulation: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals 21 CFR Part 507
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Notice November 01, 2016Guidance: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals; Small Entity Compliance Guide Availability
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Supporting & Related Material April 12, 2017Reference 4 Society of Plastics Letter May 3 2016 re The Food and Drug Administration Food Safety Modernization Act; Extension and Clarification of Compliance Dates for Certain Provisions of Four Implementing Rules
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Supporting & Related Material April 12, 2017Reference 3 Califonia Cotton Ginners Association Letter May 20 2016 re The Food and Drug Administration Food Safety Modernization Act; Extension and Clarification of Compliance Dates for Certain Provisions of Four Implem...
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Supporting & Related Material April 12, 2017List of references re The Food and Drug Administration Food Safety Modernization Act; Extension and Clarification of Compliance Dates for Certain Provisions of Four Implementing Rules
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Supporting & Related Material April 12, 2017Reference 6 Standards for the Growing Harvesting and Holding of Produce RIA re The Food and Drug Administration Food Safety Modernization Act; Extension and Clarification of Compliance Dates for Certain Provisions of Fou...
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Supporting & Related Material April 12, 2017Reference 1 GMA Industry Impacts from Disclosure and Written Assurance Requirements re The Food and Drug Administration Food Safety Modernization Act; Extension and Clarification of Compliance Dates for Certain Provision...
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Supporting & Related Material April 12, 2017Reference 2 United Fresh Produce Association Letter April 19 2016 re The Food and Drug Administration Food Safety Modernization Act; Extension and Clarification of Compliance Dates for Certain Provisions of Four Implemen...
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Supporting & Related Material April 12, 2017Reference 5 Part 117 FSMA Final Rulemaking for CGMP and HAPC for Human Food RIA re The Food and Drug Administration Food Safety Modernization Act; Extension and Clarification of Compliance Dates for Certain Provisions of...
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Rule April 02, 2019Implementing the Food and Drug Administration Food Safety Modernization Act; Technical Amendment
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Rule October 31, 2022Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food and Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals; Supply-Chain Programs and ...
Public comments
What people are saying
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Anonymous commenter 2018-03-05
“On Page 21 of Chapter 4.3.3.1 Use of Water Activity as a Formulation Process Control, the last paragraph states that "Foods vary in their water activity as shown in Table 4-10. Although, you can measure the water activity of your specific product if you have the appropriate equipment, for many purposes you rely on the water activity values shown in Table 4-10." This is a very dangerous statement to give producers the idea that they can rely on a table for their water activity. Products that all fall within a common product type can vary greatly in water activity depending on the formulation...”
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Anonymous commenter 2015-01-30
Comment from Ecolab Inc.
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Anonymous commenter 2015-01-09
“To whom it may concerns, Reference is made to Docket No. FDA-2011-N-0922 regarding the proposed supplemental rule on Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals (hereafter referred to as proposed rule) dated September 29, 2014. National Bureau of Agricultural Commodity and Food Standards (ACFS), Thailand SPS contact and enquiry point, appreciated the opportunity to provide comments on the proposed rule and would like to submit these comments for your consideration: 1)Environmental monitoring requirements: As the proposed ru...”
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Anonymous commenter 2015-01-09
“On behalf of the Florida Department of Agriculture and Consumer Services please find attached comments and a letter from the Florida Commissioner of Agriculture and Consumer Services on the Animal Preventive Controls rule.”
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Anonymous commenter 2015-01-09
“See attached file(s)”
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