Source: https://www.federalregister.gov/documents/2013/03/20/2013-06356/current-good-manufacturing-practice-and-hazard-analysis-and-risk-based-preventive-controls-for-human?source=govdelivery
Timestamp: 2017-06-23 16:05:36
Document Index: 578163683

Matched Legal Cases: ['§\u2009117', '§\u2009117', '§\u2009117', '§\u2009117', '§\u2009117', '§\u2009117', '§\u2009120']

:: Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food; Correction
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.
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3. On page 3728, in the first column of “Table 11—Potential Revisions to Establish Requirements in Place of Current Guidance,” in the fifth entry, “§ 117.40(a)(1)” is corrected to read “§ 117.40(a)(3)”.
4. On page 3728, in the second column of “Table 11—Potential Revisions to Establish Requirements in Place of Current Guidance,” in the fifth entry, the word “must” in “All Start Printed Page 17143equipment must be so installed” is corrected to be italicized and read “must” for emphasis.
9. In proposed § 117.135(d)(3)(iv), on page 3806, in the third column, “records review in accordance with § 117.150(d)(5)(i)” is corrected to read “records review in accordance with § 117.150(d)(2)(i)”.
Testing a raw material or ingredient is more useful, and a facility generally tests a raw material or ingredient more frequently, when the raw material or ingredient contains a hazard for which there is a reasonable Start Printed Page 17144probability that exposure to the hazard will result in serious adverse health consequences or death to humans or animals. However, when a hazard that the receiving facility has identified as reasonably likely to occur in a raw material or ingredient is one for which the receiving facility has preventive controls that significantly minimize or prevent the hazard, testing generally is less frequent. An exception to this general paradigm is when the process control depends on the amount of the hazard present in the raw material or ingredient (e.g., when the process control is effective at eliminating 100 microorganisms per gram of ingredient, but not 1000 microorganisms per gram of ingredient) and there is a need to verify that the hazard is not present in amounts that would render the process control ineffective. A receiving facility often finds that testing of raw materials or ingredients is most useful, and generally tests more frequently, when the receiving facility does not have a process that would significantly minimize the hazard and is relying on preventive controls earlier in the supply chain to significantly minimize or prevent the hazard in the raw material or ingredient, as in a bagged salad facility or a dry-mix operation producing, for example, spice blends or trail mix. In such situations, the testing is conducted to verify the preventive controls used to ensure that hazards in the raw material or ingredient have been significantly minimized or prevented.
As discussed in section II.D of the preamble of this document, food can become contaminated with pathogenic microorganisms at many different steps in the farm-to-table continuum. Any time a food is exposed to the environment during a manufacturing, processing, packing, or holding activity, there is the potential for the food to be contaminated with pathogenic microorganisms. As discussed in section X.B of the preamble of this document, proposed § 117.3 would define the term “environmental pathogen” to mean a microorganism that is of public health significance and is capable of surviving and persisting within the manufacturing, processing, packing, or holding environment. The environmental pathogens most frequently involved in the contamination of foods leading to foodborne illness are Salmonella spp. and L.
If a harborage site contains nutrients (i.e., food) and water and is exposed to a temperature that falls within the growth range of the environmental pathogen, the pathogen can multiply, which increases the chance that it will be transferred to other sites (including food-contact surfaces) and to food. Transfer can occur by people (e.g., if a person touches the contaminated site and then touches other objects, or tracks the pathogen from the contamination site to other sites on shoes), by equipment (e.g., if the pathogen is picked up by the wheels of a cart or forklift and is transferred to other locations), by water (e.g., water that contacts the harborage site is splashed onto other areas, including equipment, or aerosols containing the pathogen transfer it to other areas) or by air (dissemination of contaminated dust particles by air handling systems) (Ref. 8) (Ref. 9) (Ref. 19) (Ref. 17). Start Printed Page 17145Such transfer mechanisms from harborage sites can result in intermittent contamination of food-contact surfaces and food over long periods of time, often with the same strain of the pathogen (Ref. 8) (Ref. 16) (Ref. 19) (Ref. 20).
Start Printed Page 17146that persisted in an ice cream plant in Finland for several years and occasionally contaminated finished product (Ref. 52). A volumetric doser was found to be the source of L. monocytogenes in sauces produced in a fresh sauce production plant in Italy (Ref. 53), and slicers and conveyor belts were found to contribute to contamination of sandwiches in a Swiss sandwich producing plant (Ref. 54). L. monocytogenes also has been found on tables, water hoses, air guns, floors, gloves, drains and a bread-feeding machine (Ref. 54).
Tests for the indicator organism Listeria spp. detect multiple species of Listeria, including the pathogen L. monocytogenes. There is Federal precedent for the use of Listeria spp. as an appropriate indicator organism for L. monocytogenes. FSIS has established regulations requiring FSIS-regulated establishments that produce RTE Start Printed Page 17147meat or poultry products exposed to the processing environment after a lethality procedure (e.g., cooking) to prevent product adulteration by L. monocytogenes.
Salmonella spp. is usually the environmental pathogen of concern for most dry (e.g., low-moisture) RTE food Start Printed Page 17148environments. Equipment used in the production of dry products is rarely wet and, thus, there is no moisture to allow growth of Salmonella spp. As a result, Salmonella harborage sites are less likely to be found on equipment and are more likely to be found in the environment in locations where food particles lodge and escape a dry cleaning process. When these locations get wet, the Salmonella spp. grows and contaminates other areas of the facility, eventually contaminating food-contact surfaces and food. Nevertheless, sampling food-contact surfaces (e.g., filler hoppers, conveyors, valves, sifter cuffs) can be useful, as can sampling residues such as sifter tailings and product scrapings.
Finished product testing could be appropriate if an environmental pathogen is detected on a non-food-contact surface, such as on the exterior of equipment, on a floor or in a drain. The potential for food to be contaminated directly from contamination in Start Printed Page 17149or on a non-food-contact surface is generally low, but transfer from non-food-contact surfaces to food-contact surfaces can occur. Finished product testing can provide useful information on the overall risk of a food when pathogens have been detected in the environment. In general, finished product testing is most appropriate when an indicator organism, rather than an environmental pathogen, is detected on a food-contact surface.
Another important consideration in determining whether finished product testing is appropriate is whether a hazard can be reintroduced into a food that has been treated to significantly minimize the hazard, either through exposure to the environment or by the addition of an ingredient after a treatment to significantly minimize a hazard. For example, verification testing is not common if a lethal treatment for a pathogen is given to food in its final package (such as a marinara sauce heated in the jar or hot-filled into the jar) but would be more common if food exposed to the environment, such as a cold gazpacho filled into a container. Likewise, verification testing generally is more frequent for foods given significant handling before packaging, regardless of whether they have previously received a treatment that would significantly minimize a hazard, if they will be consumed without a treatment lethal for pathogens that can be introduced during handling (e.g., L. monocytogenes or Salmonella spp. from the environment; pathogens such as Staphylococcus aureus or Salmonella spp. from food handlers ). Verification testing also Start Printed Page 17150would be more frequent if an ingredient that has potential to be contaminated with a pathogen is added to a food that was previously treated to significantly minimize a hazard (e.g., adding seasonings to chips or crackers after frying or baking) than if all ingredients are added before the treatment.
Table 1—Probability of Detecting Salmonella spp. in Lots at Various Contamination Rates Under the Three Different IOM Salmonella Sampling Plans (Left) and the Expected Number of Positive Composite Samples Using Weekly Testing for 1 Year Under the IOM Salmonella Sampling Plans (Right) Probability of detecting Salmonella spp. in a lot (percent)Expected # of positive composites per year (weekly testing)Contamination RateCFU/g or CFU/kgN=15*n=30*n=60*n=15*n=30*n=60*1 in 101/250g7996>9940811621 in 301/750g4064872041821 in 1001/2.5kg142645715291 in 3001/7.5kg4.910182.55101 in 10001/25kg1.535.80.81.531 in 30001/75kg0.5120.30.51* In the table, “n” is the number of subsamples (which are composited in groups of 15 for analysis).
Periodic testing for trend analysis and statistical process control, however, does provide information to assess whether processes (or the food safety system) are under control over time. Data collected from multiple lots of product produced over days, months or years are used to establish a baseline for the level of control that can be attained under a functioning food safety system and to verify the system is in control or to indicate loss of control. In addition to showing the probability of detecting contamination in a lot of product for a given contamination rate, Table 1 also shows the value of periodic testing when contamination levels are low. Even though a product with 1 in 300 contaminated units is unlikely to be rejected when sampling a single lot at the Category III sampling schedule (i.e., 4.9 percent of the time), testing of finished products with this level of contamination on a weekly basis would be expected to find 2.5 positive composite samples per year. Similarly, if the background contamination rate is thought to be near 1 in 1000 but periodic testing using the Category III schedule has found 3 positives in the last year, then it seems clear that the actual frequency of contaminated units is closer to 1 in 300. Periodic testing according to the Category I Salmonella plan has the potential to detect situations where the contamination rates are as low as 1 in 1000. If 60 samples of a food are collected weekly, then 3,120 samples would be collected over the course of a year. Compositing these 3,120 samples into 375g analytical units would reduce the number of analytical tests to 208 (4 tests per week). If 30 samples are collected weekly, and composited, there would be 104 tests annually, or two each week. At the 1 in 1000 contamination rate there would be a greater than 95 percent confidence in seeing one or more positive tests during the year for testing composites from either 60 or 30 samples weekly. At higher rates of contamination, more positives would be detected.Start Printed Page 17151
There can be significant benefits to a facility testing finished products over time for process control. First, if a lot of product tests positive for a hazard, that lot of product can be disposed of such that the consumer is not exposed to the hazard (i.e., the product can be destroyed, reprocessed, or diverted to another use, as appropriate). If the testing involves enumeration of an indicator organism, it may even be possible to detect a trend toward loss of control before exceeding the criterion that separates acceptable from unacceptable. The process can be adjusted before there is a need to dispose of product. Second, the detection of loss of control, or potential loss of control, e.g., an unusual number of positives in a given period of time, allows a facility to evaluate and modify its processes, procedures, and food safety plan as appropriate to prevent loss of control in the future. In fact, the nature of the trends can provide information useful in determining the root cause of the problem (Ref. 61). A third benefit to ongoing verification testing is the accumulation of data that can help bracket any problem that occurs. For products in which there are large production runs without intervening sanitation cycles, this may provide data that can be used in conjunction with other information to limit the scope of a recall. A fourth benefit may be in detection of a problem associated with an ingredient supplier that results in changes to a supplier's processes, procedures, or food safety plan. For example, a positive in finished product due to routine verification testing was responsible for determining that hydrolyzed vegetable protein was contaminated with Salmonella spp., resulting in over 177 products being recalled (Ref. 84) and a recognition of the need for enhanced preventive controls for the production of this ingredient (Ref. 27). Industry commonly uses finished product testing to verify preventive controls used by the facility and by the facility's suppliers. Additionally, it is common for customers to require suppliers to conduct testing of products and ingredients being provided.
Recently there has been much attention paid to microbiological risk management metrics for verifying that food safety systems achieve a specified level of public health control, e.g., the Appropriate Level of Protection (ALOP), for microbial hazards. Microbiological risk management metrics are fully discussed in Annex II of the Codex “Principles and Guidelines for the Conduct of Microbiological Risk Management (MRM)” (Ref. 85). These metrics include traditional metrics such as microbiological criteria, process criteria, and product criteria and emerging metrics such as food safety objectives (FSO), performance objectives and performance criteria. Of particular relevance are performance objectives and performance criteria. A performance objective is the maximum frequency and/or concentration of a microbiological hazard in a food at a specified step in the food chain before the time of consumption that provides or contributes to an FSO or ALOP, as applicable (Ref. 86). A performance criterion is the effect in frequency and/or concentration of a hazard in a food that must be achieved by the application of one or more control measures to provide or contribute to a performance objective or an FSO (Ref. 86). FDA established a performance criterion (or performance standard) when we required that processors of juice products apply a control measure that will consistently produce, at a minimum, a 5-log reduction for the most resistant microorganism of public health significance (§ 120.24). Section 104 of FSMA (Performance Standards) requires the Secretary to determine the most significant foodborne contaminants and issue contaminant-specific and science-based guidance documents, including guidance documents regarding action levels, or regulations for products or product classes. The proposed rule that is the subject of this document would not establish criteria or metrics for verifying that preventive controls in food safety plans achieve a specified level of public health control in this proposed rule. However, FDA will give consideration to appropriate microbiological risk management metrics in the future.
Supplier approval and verification is widely accepted in the domestic and international food safety community. The NACMCF HACCP guidelines describe Supplier Control as one of the common prerequisite programs for the safe production of food products and recommend that each facility should ensure that its suppliers have in place effective GMP and food safety programs (Ref. 1). The American Spice Trade Association advocates that spice manufacturers establish robust supplier prerequisite programs to evaluate and approve suppliers (Ref. 93). The Grocery Manufacturers Association's (GMA's) Food Supply Chain Handbook, developed for ingredient suppliers to the food industry, recommends that all suppliers in the food chain consider approval programs for their own suppliers; such supplier approval programs consist of a collection of appropriate programs, specifications, Start Printed Page 17152policies, and procedures (Ref. 92). GMA recommends a number of verification activities that suppliers can take in its Food Supply Chain Handbook, including self-auditing, third-party auditing and product testing. GMA's handbook also references verification activities that a supplier's customers might take, including second-party audits (done by an employee of the customer) or third-party (independent) audits (conducted by persons who do not work for either the supplier or the customer). Codex specifies that no raw material or ingredient should be accepted by an establishment if it is known to contain parasites, undesirable microorganisms, pesticides, veterinary drugs or toxic, decomposed or extraneous substances which would not be reduced to an acceptable level by normal sorting and/or processing (Ref. 94). Codex also specifies that, where appropriate, specifications for raw materials should be identified and applied and that, where necessary, laboratory tests should be made to establish fitness for use (Ref. 94).
1. National Advisory Committee on Microbiological Criteria for Foods, “Hazard Analysis and Critical Control Point Principles and Application Guidelines,” Journal of Food Protection, 61:1246-1259, 1998.
7. CDC, “General Information. Escherichia coli (E. coli),” (http://www.cdc.gov/​ecoli/​general/​index.html), July 17, 2012. Accessed and printed on July 27, 2012.
8. Scott, V. N., C. Yuhuan, 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 I: Minimizing Entry of Salmonella into a Processing Facility,” Food Protection Trends, 29:342-353, 2009.
9. 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 II: Hygiene Practices to Minimize Salmonella Contamination and Growth,” Food Protection Trends, 29:435-445, 2009.
10. California Department of Public Health, “Union International Food Company Recall Widened Again,” (http://www.cdph.ca.gov/​Pages/​NR2009-23.aspx), April 4, 2009. Accessed and printed on September 6, 2011.
11. Gabis, D. A., R. S. Flowers, D. Evanson, and R. E. Faust, “A Survey of 18 Dry Start Printed Page 17153Product Processing Plant Environments for Salmonella, Listeria and Yersinia,” Journal of Food Protection, 52:122-124, 1989.
12. Vij, V., E. Ailes, C. Wolyniak, F. J. Angulo, and K. C. Klontz, “Recalls of Spices Due to Bacterial Contamination Monitored by the U.S. Food and Drug Administration: The Predominance of Salmonellae,” Journal of Food Protection, 69:233-237, 2006.
13. FDA, “FDA Foods Program, The Reportable Food Registry: A New Approach to Targeting Inspection Resources and Identifying Patterns of Adulteration. First Annual Report: September 8, 2009-September 7, 2010,” (http://www.fda.gov/​downloads/​Food/​FoodSafety/​FoodSafetyPrograms/​RFR/​UCM240647.pdf), January, 2011. Accessed and printed on August 29, 2011.
14. FDA and USDA, “Listeria monocytogenes Risk Assessment: VII. Interpretation and Conclusions,” (http://www.fda.gov/​Food/​ScienceResearch/​ResearchAreas/​RiskAssessmentSafetyAssessment/​ucm185289.htm), September, 2003. Accessed and printed on October 17, 2011.
18. Tompkin, R. B., “Control of Listeria monocytogenes in the Food-Processing Environment,” Journal of Food Protection, 65:709-725, 2002.
19. Carpentier, B., and O. Cerf, “Review: Persistence of Listeria monocytogenes in Food Industry Equipment and Premises,” International Journal of Food Microbiology, 145:1-8, 2011.
20. Breuer, T., “CDC Investigations: The May 1998 Outbreak of Salmonella Agona Linked to Cereal,” Cereal Foods World, 44:185-186, 1999.
23. CDC, “Investigation of Outbreak of Infections Caused by Salmonella Agona,” (http://www.cdc.gov/​salmonella/​agona/​), May 13, 2008. Accessed and printed on September 9, 2011.
25. CDC, “Multistate Outbreak of Salmonella Serotype Tennessee Infections Associated with Peanut Butter—United States, 2006-2007,” MMWR, 56:521-524, 2007.
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29. Cavallaro, E., K. Date, C. Medus, S. Meyer, B. Miller, C. Kim, S. Nowicki, S. Cosgrove, D. Sweat, P. Quyen, J. Flint, E. R. Daly, J. Adams, E. Hyytia-Trees, P. Gerner-Smidt, R. M. Hoekstra, C. Schwensohn, A. Langer, S. V. Sodha, M. C. Rogers, F. J. Angulo, R. V. Tauxe, I. T. Williams, and C. Barton Behravesh, “Salmonella Typhimurium Infections Associated with Peanut Products,” New England Journal of Medicine, 365:601-610, 2011.
30. FDA, “Amended Form 483 (Inspectional Observations) for Peanut Corporation of America, Blakely, GA, 02/05/2009,” (http://www.fda.gov/​downloads/​AboutFDA/​CentersOffices/​ORA/​ORAElectronicReadingRoom/​UCM109834.pdf), February 5, 2009. Accessed and printed on October 19, 2011.
31. FDA, “Form 483 (Inspectional Observations) for Peanut Corporation of America, Plainview, TX, 02/26/2009,” (http://www.fda.gov/​downloads/​AboutFDA/​CentersOffices/​ORA/​ORAElectronicReadingRoom/​UCM114852.pdf), February 26, 2009. Accessed and printed on October 17, 2011.
33. FDA, “Company Recalls Various Products Due to Potential Salmonella Contamination. FDA, USDA, CDC Investigating; No Link to Human Illnesses at This Time,” (http://www.fda.gov/​NewsEvents/​Newsroom/​PressAnnouncements/​ucm169471.htm), June 28, 2009. Accessed and printed on September 9, 2011.
34. FDA, “FDA Form 483 (Inspectional Observations) for Plainview Milk Products Cooperative,” (http://www.fda.gov/​downloads/​AboutFDA/​CentersOffices/​ORA/​ORAElectronicReadingRoom/​UCM173030.pdf), July 15, 2009. Accessed and printed on September 9, 2011.
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36. Jackson, K. A., M. Biggerstaff, M. Tobin-D'Angelo, D. Sweat, R. Klos, J. Nosari, O. Garrison, E. Boothe, L. Saathoff-Huber, L. Hainstock, and R. P. Fagan, “Multistate Outbreak of Listeria monocytogenes Associated with Mexican-Style Cheese Made from Pasteurized Milk Among Pregnant, Hispanic Women,” Journal of Food Protection, 74:949-953, 2011.
37. Texas Department of State Health Services, “DSHS Orders Sangar Produce to Close, Recall Products,” (http://www.dshs.state.tx.us/​news/​releases/​20101020.shtm), October 20, 2010. Accessed and printed on September 9, 2011.
38. FDA, “FDA Form 483 (Inspectional Observations) for Sangar Fresh Cut Produce Co., LLC,” (http://www.fda.gov/​downloads/​AboutFDA/​CentersOffices/​ORA/​ORAElectronicReadingRoom/​UCM232412.pdf), October 26, 2010. Accessed and printed on September 9, 2011.
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