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Proposed RuleSignificant2013-063562013-03-20

Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food; Correction

Health and Human Services Department, Food and Drug Administration

Abstract

The Food and Drug Administration (FDA or we) is correcting a proposed rule that published in the Federal Register of January 16, 2013. That proposed rule would amend our regulation for current good manufacturing practice in manufacturing, packing, or holding human food (CGMPs) to modernize it and to add requirements for domestic and foreign facilities that are required to register under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to establish and implement hazard analysis and risk-based preventive controls for human food. That proposed rule also would revise certain definitions in our current regulation for registration of food facilities to clarify the scope of the exemption from registration requirements provided by the FD&C Act for "farms." We proposed these actions as part of our announced initiative to revisit the CGMPs since they were last revised in 1986 and to implement new statutory provisions in the FD&C Act. The document published with several typographical errors, stylistic errors (such as incorrect indentation of bulleted paragraphs and a gap in the sequential numbering of tables), and a mistake in the date of a reference. The document also published with an Appendix in which all references are numbered incorrectly. This document corrects those errors.

Action & Dates

Action
Proposed rule; correction.
Dates
Multinational Listeriosis Outbreak Due to "Quargel", a Sour Milk Curd Cheese, Caused by Two Different L. Monocytogenes Serotype 1/2a Strains, 2009-2010," Eurosurveillance, 15:2, 2010. 45. FDA, "River Ranch Recalls Products Because of Possible Health Risk," (http://www.fda.gov/Safety/Recalls/ucm275854.htm), October 13, 2011. Accessed and printed on October 26, 2011. 46. FDA, "Taylor Farms Retail Inc. Initiates a Precautionary Recall Because of Possible Health Risk," (http://www.fda.gov/Safety/ Recalls/ucm276459.htm), October 19, 2011. Accessed and printed on October 20, 2011. 47. FDA, "Del Bueno Recalls Queso Fresco Casero Cheese Because of Possible Health Risk," (http://www.fda.gov/Safety/Recalls/ ucm272268.htm), September 16, 2010. Accessed and printed on October 26, 2011. 48. FDA, "Fine Mexican Food Products, Inc. Recalls 2.2 lb. Frozen Avocado Pulp & 3 lb. IQF Avocado Halves from Peru Because of Possible Health Risk," (http://www.fda.gov/Safety/Recalls/ ucm271686.htm), September 13, 2011. Accessed and printed on November 23, 2011. 49. Cox, L. J., T. Kleiss, J. L. Cordier, C. Cordellana, P. Konkel, C. Pedrazzini, R. Beumer, and A. Siebenga, "Listeria spp. in Food Processing, Non-Food and Domestic Environments," Food Microbiology, 6:49-61, 1989. 50. Nelson, J. H., "Where Are Listeria Likely to be Found in Dairy Plants?" Dairy, Food and Environmental Sanitation, 10:344-345, 1990. 51. Pritchard, T. J., K. J. Flanders, and C. W. Donnelly, "Comparison of the Incidence of Listeria on Equipment Versus Environmental Sites Within Dairy Processing Plants," International Journal of Food Microbiology, 26:375-384, 1995. 52. Miettinen, M. K., K. J. Bjorkroth, and H. J. Korkeala, "Characterization of Listeria monocytogenes from an Ice Cream Plant by Serotyping and Pulsed-Field Gel Electrophoresis," International Journal of Food Microbiology, 46:187-192, 1999. 53. Pourshaban, M., M. Gianfranceschi, A. Gattuso, F. Menconi, and P. Aureli, "Identification of Listeria monocytogenes Contamination Sources in Two Fresh Sauce Production Plants by Pulsed-Field Gel Electrophoresis," Food Microbiology, 17:393-400, 2000. 54. Blatter, S., N. Giezendanner, R. Stephan, and C. Zweifel, "Phenotypic and Molecular Typing of Listeria monocytogenes Isolated from the Processing Environment and Products of a Sandwich-Producing Plant," Food Control, 21:1519-1523, 2010. 55. Pappelbaum, K., K. Grif, I. Heller, R. Wuerzner, I. Hein, L. Ellerbroek, and M. Wagner, "Monitoring Hygiene On- and At-Line Is Critical for Controlling Listeria monocytogenes During Produce Processing," Journal of Food Protection, 71:735-741, 2008. 56. Aguado, V., A. I. Vitas, and I. Garcia-Jalon, "Characterization of Listeria monocytogenes and Listeria innocua from a Vegetable Processing Plant by RAPD and REA," International Journal of Food Microbiology, 90:341-347, 2004. 57. Codex Alimentarius Commission, "Guidelines on the Application of General Principles of Food Hygiene to the Control of Listeria monocytogenes in Ready-to-Eat Foods, CAC/GL 61--2007," 2007. 58. Scott, V. N., M. Wiedmann, D. Hicks, R. Collette, M. L. Jahncke, and K. Gall, "Guidelines for Listeria Testing of Environmental, Raw Product and Finished Product Samples in Smoked Seafood Processing Facilities," Food Protection Trends, 25:23-34, 2005. 59. Chen, Y., V. N. Scott, T. A. Freier, J. Kuehm, M. Moorman, J. Meyer, T. Morille-Hinds, L. Post, L. Smoot, S. Hood, J. Shebuski, and J. Banks, "Control of Salmonella in Low-Moisture Foods III: Process Validation and Environmental Monitoring," Food Protection Trends, 29:493-508, 2009. 60. Jarl, D. L. and E. A. Arnold, "Influence of Drying Plant Environment on Salmonellae Contamination of Dry Milk Products," Journal of Food Protection, 45:16, 1982. 61. Buchanan, R. L., "Acquisition of Microbiological Data to Enhance Food Safety," Journal of Food Protection, 63:832-838, 2000. 62. National Advisory Committee on Microbiological Criteria for Foods, "Response to the Questions Posed by FSIS Regarding Performance Standards with Particular Reference to Ground Beef Products," (http://www.fsis.usda.gov/OPHS/NACMCF/2002/rep_ stand2.pdf), October 8, 2002. Accessed and printed on September 12, 2011. 63. Evancho, G. M., W. H. Sveum, L. J. Moberg, and J. F. Frank, "Microbiological Monitoring of the Food Processing Environment," In: Compendium of Methods for the Microbiological Examination of Foods, edited by F. P. Downes and K. Ito, 4th edition, Washington, DC, Chapter 3, pp. 25-35, American Public Health Association, 2001. 64. FSIS, "FSIS Compliance Guideline: Controlling Listeria monocytogenes in Post-Lethality Exposed Ready-to-Eat Meat and Poultry Products," 2012. 65. Kraft Foods, "Re: Docket No. 2007D-0494; Draft Guidance for Industry: Control of Listeria monocytogenes in Refrigerated or Frozen Ready-to-Eat Foods; Availability," 2008. 66. Kraft Foods, "Appendix, Comments on the FDA Guidance for Industry, Control of Listeria monocytogenes in Refrigerated or Frozen Ready-to-Eat Foods," 2008. 67. Grocery Manufacturers Association, "Re: Docket No. 2007-D-0494: Draft Guidance for Industry: Control of Listeria monocytogenes in Refrigerated or Frozen Ready-to-Eat Foods; Availability," 2008. 68. Alliance for Listeriosis Prevention, "Re: Docket No. 2007-D- 0494: Draft Guidance for Industry: Control of Listeria monocytogenes in Refrigerated or Frozen Ready-to-Eat Foods; Availability," 2008. 69. CGMP Coalition, "Re: Docket No. 2004N-0230; Food, Current Good Manufacturing Practice Regulations," 2006. 70. European Food Safety Authority, "Scientific Opinion of BIOHAZ Panel on the Request from the Commission for Review of the Opinion on Microbiological Risks in Infant Formulae and Follow-on Formulae with Regard to Enterobacteriaceae As Indicators," The EFSA Journal, 444:1-14, 2007. 71. International Commission on Microbiological Specifications for Foods, "Drying Foods for Infants and Young Children," In: Microorganisms in Foods 8. Use of Data for Assessing Process Control and Product Acceptance, edited by K. M. J. Swanson, R. L. Buchanan, M. B. Cole, J.-L. Cordier, R. S. Flowers, L. G. M. Gorris, M. H. Taniwaki, and R. B. Tompkin, New York, Chapter 25, pp. 339-348, Springer, 2011. 72. International Commission on Microbiological Specifications for Foods, "Cereal and Cereal Products," In: Microorganisms in Foods 8. Use of Data for Assessing Process Control and Product Acceptance, edited by K. M. J. Swanson, R. L. Buchanan, M. B. Cole, J.-L. Cordier, R. S. Flowers, L. G. M. Gorris, M. H. Taniwaki, and R. B. Tompkin, New York, Chapter 15, pp. 218-219, Springer, 2011. 73. International Commission on Microbiological Specifications for Foods, "Spice, Dry Soups and Asian Flavorings," In: Microorganisms in Foods 8. Use of Data for Assessing Process Control and Product Acceptance, edited by K. M. J. Swanson, R. L. Buchanan, M. B. Cole, J.-L. Cordier, R. S. Flowers, L. G. M. Gorris, M. H. Taniwaki, and R. B. Tompkin, New York, Chapter 14, pp. 199, Springer, 2011. 74. International Commission on Microbiological Specifications for Foods, "Cereal and Cereal Products," In: Microorganisms in Foods 8. Use of Data for Assessing Process Control and Product Acceptance, edited by K. M. J. Swanson, R. L. Buchanan, M. B. Cole, J.-L. Cordier, R. S. Flowers, L. G. M. Gorris, M. H. Taniwaki, and R. B. Tompkin, New York, Chapter 15, pp. 216, Springer, 2011. 75. International Commission on Microbiological Specifications for Foods, "Nuts, Oilseeds, Dried Legumes and Coffee," In: Microorganisms in Foods 8. Use of Data for Assessing Process Control and Product Acceptance, edited by K. M. J. Swanson, R. L. Buchanan, M. B. Cole, J.-L. Cordier, R. S. Flowers, L. G. M. Gorris, M. H. Taniwaki, and R. B. Tompkin, New York, Chapter 16, pp. 230, Springer, 2011. 76. International Commission on Microbiological Specifications for Foods, "Cocoa, Chocolate and Confectionery," In: Microorganisms in Foods 8. Use of Data for Assessing Process Control and Product Acceptance, edited by K. M. J. Swanson, R. L. Buchanan, M. B. Cole, J.-L. Cordier, R. S. Flowers, L. G. M. Gorris, M. H. Taniwaki, and R. B. Tompkin, New York, Chapter 17, pp. 241-246, Springer, 2011. 77. International Commission on Microbiological Specifications for Foods, "Milk and Dairy Products," In: Microorganisms in Foods 8. Use of Data for Assessing Process Control and Product Acceptance, edited by K. M. J. Swanson, R. L. Buchanan, M. B. Cole, J.-L. Cordier, R. S. Flowers, L. G. M. Gorris, M. H. Taniwaki, and R. B. Tompkin, New York, Chapter 23, pp. 315, Springer, 2011. 78. Proudy, I., D. Bougle, R. Leclercq, and M. Vergnaud, "Tracing of Enterobacter sakazakii Isolates in Infant Milk Formula Processing by BOX-PCR Genotyping," Journal of Applied Microbiology, 105:550- 558, 2008. 79. Mullane, N. R., P. Whyte, P. G. Wall, T. Quinn, and S. Fanning, "Application of Pulsed-Field Gel Electrophoresis to Characterise and Trace the Prevalence of Enterobacter sakazakii in an Infant Formula Processing Facility," International Journal of Food Microbiology, 116:73-81, 2007. 80. International Commission on Microbiological Specifications for Foods, "Establishment of Microbiologial Criteria for Lot Acceptance," In: Microorganisms in Foods 7. Microbiological Testing in Food Safety Management, edited by R. B. Tompkin, L. Gram, T. A. Roberts, R. L. Buchanan, M. van Schothorst, S. Dahms, and M. B. Cole, New York, Chapter 5, pp. 99-112, Kluwer Academic/Plenum Publishers, 2002. 81. FDA, "Investigations Operations Manual (IOM)," 2011. 82. FDA, "Bacteriological Analytical Manual, 8th Edition, Revision A, 1998," 1998. 83. FDA, "Bacteriological Analytical Manual (BAM), Chapter 1. Food Sampling and Preparation of Sample Homogenate," 2003. 84. FDA, "Recall: Products Containing Hydrolyzed Vegetable Protein," (http://www.accessdata.fda.gov/scripts/HVPCP/), April 1, 2010. Accessed and printed on September 9, 2011. 85. Codex Alimentarius Commission, "Principles and Guidelines for the Conduct of Microbiological Risk Management (MRM), CAC/GL 63- 2007," 2007. 86. Codex Alimentarius Commission, "Codex Alimentarius Commission Procedural Manual, Twentieth Edition," 2011. 87. FDA, "Pistachios and Other Pistachio Containing Products Recall List," (http://www.accessdata.fda.gov/scripts/pistachiorecall/ index.cfm), June 23, 2009. Accessed and printed on September 9, 2011. 88. FDA, "Plainview Milk Cooperative Ingredient Recall," (http:// www.fda.gov/Safety/Recalls/MajorProductRecalls/Milk/default.htm), July 23, 2009. Accessed and printed on September 9, 2011. 89. FDA, "Plainview Milk Cooperative Ingredient Recall Product List," (http://www.accessdata.fda.gov/scripts/Milk/), July 28, 2009. Accessed and printed on September 9, 2011. 90. FDA, "For Consumers: The HVP Recall (Updated)," (http:// www.fda.gov/Food/NewsEvents/WhatsNewinFood/ucm202989.htm), March 24, 2010. Accessed and printed on October 14, 2011. 91. FDA Memorandum, "Analysis of Food Recalls Initiated in 2008- 2009 by an FDA CGMP Working Group," 2012. 92. Grocery Manufacturers Association, "Food Supply Chain Handbook," 2008. 93. American Spice Trade Association, "Clean, Safe Spices," 2011. 94. Codex Alimentarius Commission, "General Principles of Food Hygiene, CAC/RCP 1-1969 (Rev. 4-2003)," 2003. 95. FDA, "Guidance for Industry--Voluntary Third-Party Certification Programs for Foods and Feeds," 2009. 96. Global Food Safety Initiative, "GFSI Guidance Document, Version 6.1," (http://www.mygfsi.com/gfsifiles/Guidance_Document_Sixth_ Edition_Version_6.1.pdf), August, 2011. Accessed and printed on October 17, 2011.

CFR References

Public Comment

Comments Close
2011-10-17

Document Excerpt

Document Headings Document headings vary by document type but may contain the following: the agency or agencies that issued and signed a document the number of the CFR title and the number of each part the document amends, proposes to amend, or is directly related to the agency docket number / agency internal file number the RIN which identifies each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions See the Document Drafting Handbook for more details. Department of Health and Human Services Food and Drug Administration 21 CFR Parts 1, 16, 106, 110, 114, 117, 120, 123, 129, 179, and 211 [Docket No. FDA-2011-N-0920] RIN 0910-AG36 AGENCY: Food and Drug Administration, HHS. ACTION: Proposed rule; correction. SUMMARY: The Food and Drug Administration (FDA or we) is correcting a proposed rule that published in the Federal Register of January 16, 2013. That proposed rule would amend our regulation for current good manufacturing practice in manufacturing, packing, or holding human food (CGMPs) to modernize it and to add requirements for domestic and foreign facilities that are required to register under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to establish and implement hazard analysis and risk-based preventive controls for human food. That proposed rule also would revise certain definitions in our current regulation for registration of food facilities to clarify the scope of the exemption from registration requirements provided by the FD&C Act for “farms.” We proposed these actions as part of our announced initiative to revisit the CGMPs since they were last revised in 1986 and to implement new statutory provisions in the FD&C Act. The document published with several typographical errors, stylistic errors (such as incorrect indentation of bulleted paragraphs and a gap in the sequential numbering of tables), and a mistake in the date of a reference. The document also published with an Appendi

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Citation: 78 FR 17142