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,Click to edit Master title style,Click to edit Master text styles,Second level,Third level,Fourth level,Fifth level,*,*,*,USDA-FSISFood Safety StandardsChemical, Microbiological,Elizabeth A. Krushinskie, DVM, PhD,VP, Food Safety & Production Programs,U.S. Poultry & Egg Association,Overview,USDA-FSIS Chemical residue testing program,USDA-FSIS Microbiological testing programs,E. coli,Salmonella,USDA-FSIS Chemical Residue Testing Program,Program is outlined in the USDA “Blue Book,Test results are presented in the USDA “Red Book,Named for the color of the covers of the books,Available on-line at USDA website,Overview,An essential aspect of food safety in poultry products is the control of residues that may result from the use of animal drugs and pesticides, and from incidents involving environmental contamination,Overview,The United States has a complex residue control program with rigorous processes for approval, sampling, testing, and enforcement,Overview,Three federal agencies are involved:,USDA Food Safety and Inspection Service (USDA-FSIS),Food and Drug Administration (FDA),Environmental Protection Agency (EPA),Overview,FDA and EPA establish maximum permissible levels of residues (tolerances),FSIS enforces these tolerances through various control programs,Overview,FDA establishes tolerances for veterinary drugs and food additives under the statutory authority of the Federal Food, Drug, and Cosmetic Act (FFDCA),These tolerances are published in Title 21 of the Code of Federal Regulations (21CFR),Overview,EPA establishes tolerances for pesticides under the statutory authority of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA),These tolerances are published in Title 40 of the Code of Federal Regulations (40CFR),Overview,Action levels for industrial chemicals (such as PCBs) are established by FDA or FSIS based on recommendations published by EPA in the Federal Register,Overview,Under the Poultry Products Inspection Act (PPIA), FSIS acts to ensure that USDA-inspected poultry products do not contain illegal levels of chemical residues,The cornerstone of this activity is the FSIS National Residue Program (NRP),National Residue Program,A multi-component analytical testing program for residues in domestic and imported meat, poultry, and egg products,In effect since 1967,Provides a variety of sampling strategies to prevent violative residues from entering the food supply,Develops a national database on the occurrence of residues,National Residue Program,The range of chemical compounds evaluated is comprehensive in scope and includes approved and unapproved pharmaceuticals and pesticides,It also includes naturally occurring compounds that may appear in meat, poultry, or egg products that may pose a risk to human health,National Residue Program,NRP is designed to provide:,A structured process for identifying and evaluating compounds of concern,The capability to analyze for compounds of concern,Appropriate regulatory follow-up of reports of violative tissue residues,Collection, statistical analysis, and reporting of testing results,National Residue Program,When violative residues are detected in food-producing animals submitted for slaughter, FSIS notifies the producer and other parties involved in offering these animals for sale,Product found to contain violative levels of residues is considered adulterated and is condemned,National Residue Program,If product has entered commerce, it is subject to recall or other actions,FDA and cooperating state agencies may make on-site visits to these farms,If the problem is not corrected, enforcement action, including prosecution, may be the result,National Residue Program,As of September 5, 2001, FSIS has been posting to their website the names and addresses of parties that FDA has determined are responsible for more than one residue violation in a 12-month period,National Residue Program,An additional function is to provide verification of residue control in HACCP systems,The ultimate responsibility for ensuring that product is not adulterated when it enters commerce rests with the slaughter and processing establishments that produced the product,National Residue Program,In developing HACCP plans, slaughter establishments must address all chemical, physical, and biological hazards that are reasonably likely to occur in the animals entering their facilities,National Residue Program,Therefore, slaughter establishments are required to identify all chemical residue hazards that are reasonably likely to occur and develop systems to guard against them,A vigilant chemical residue prevention program is essential to foster prudent use of drugs and pesticides in animals that enter the human food supply,National Residue Program,More information:,USDA-FSIS Microbiological Testing Programs,Microbiological testing for foodborne pathogens in poultry is part of the Pathogen Reduction-HACCP rule (PR-HACCP) and is composed of two parts,Generic,E. coli,Salmonella,Generic,E. coli,Fecal contamination is one of the principal sources of pathogenic organisms that contaminate carcasses.,The best indicator of fecal contamination is,Escherichia coli, Biotype I (generic,E. coli,) because it is commonly found in the intestinal tract of food animals,Generic,E. coli,The intestinal tract is also the primary pathway for contamination of meat and poultry with other enteric pathogens such as,E. coli,O157:H7,Salmonella, and,Campylobacter,Generic,E. coli,Ongoing,E. coli,testing by slaughter establishments helps them detect the presence or absence of microbiological organisms in order to determine whether the slaughter process is,under control,or whether carcasses are being contaminated with feces.,In other words, testing is an objective process control indicator for fecal contamination,Generic,E. coli,9CFR381.94,the regulation which describes the poultry generic,E. coli,testing program,Testing for generic,E. coli,is done by slaughter establishment employees,Verification that the regulatory requirements are being met is done by FSIS employees,Generic,E. coli,The,E. coli,performance criteria are,not,enforceable regulatory standards,Criteria numbers published in the regulations represent the highest expected microbial loads on carcasses when the slaughter process is in control,Criteria give establishments guidance about the effectiveness of their system in preventing fecal contamination,Generic,E. coli,Test frequency,Chickens1 test per 22,000 carcasses,Turkeys1 test per 3,000 carcasses,Sample type,Chickenscarcass rinse,Turkeyscarcass rinse or sponge,Specific directions are in FSIS Notice 56-02,Generic,E. coli,Location of testing,Poultry samples are collected at the end of the chiller or drip line or at the last readily accessible point prior to packing or cut-up,Carcasses must be selected in a random manner,Generic,E. coli,Sample analysis,The laboratory analyzing the samples must use an AOAC Official Method,E. coli,results are reported in quantity,Number of colony forming units/ml of rinsate for carcass rinses,Number of CFU/cm,2,for sponge test results,Generic,E. coli,Record of test results,Establishments must keep records of,E. coli,tests for one year,They are also required to keep a table or chart of the most recent 13 test results,Generic,E. coli,Criteria,Performance criteria have not been established for all species,Poultry criteria are only available for chickens,Turkey establishments must use statistical process control for evaluating test results,There are no regulatory requirements for how statistical process controls are determined,Generic,E. coli,Chicken criteria,Lower limit of marginal range(m),100 CFU/ml,Upper limit of marginal range (M),1,000 CFU/ml,Number of samples tested,13,Maximum # permitted in marginal range,3,Generic,E. coli,Interpretation of results for chicken,An acceptable result is:,A test result is 100 CFU/ml but 1000 CFU/ml (M failure),More than 3 test results are marginal (m failure),Generic,E. coli,An establishment is not operating within these criteria when the most recent test results exceeds M or when the number of samples out of the most recent 13 samples testing at levels above m is more than 3,The process is then judged to be “out of control,Generic,E. coli,The process is not judged to be totally “in control until the window of 13 tests also shows process control,Generic,E. coli,FSIS,E. coli,criteria are guidelines, not regulatory standards,FSIS does not use company test results to take regulatory action,E. coli,test results that show lack of process control should be considered in conjunction with other information, like SSOP and HACCP performance,Generic,E. coli,Further enforcement action might be necessary if the establishment repeatedly fails to implement appropriate corrective actions or further planned actions in response to NRs documenting non-compliance with regulations,Salmonella,The Agencys,Salmonella,performance standard for raw poultry is found in 9CFR381.94,The goal of the,Salmonella,testing program is to protect the consumer from contaminated products, especially from fecal contamination, by verifying that each establishments performance meets the,Salmonella,standards,Salmonella,Salmonella,was selected as the target organism because it is a commonly reported cause of foodborne illness and is present to varying degrees in all major species,FSIS requires that beef, swine, and chicken carcasses be sampled for,Salmonella,testing,Salmonella,There are no published performance standards for turkey carcasses,Ground products, such as ground beef, ground chicken, and ground turkey are also sampled,Salmonella,The,Salmonella,testing performance standards set for the industry,are,regulatory requirements,Testing is conducted in plants by FSIS personnel, who collect both carcass and ground product samples,Salmonella,Salmonella,samples are collected using the sponge technique from turkey carcasses and using whole bird rinses for chicken carcasses,Ground samples require 25 grams of ground product,A,Salmonella,test is positive when any,Salmonella,organisms are found,Salmonella,Performance Standards,The pathogen reduction performance standard applies to,establishments, not to individual products,Products are not tested to determine their disposition, but rather to measure the effectiveness of the slaughter and grinding process in limiting,Salmonella,contamination,Salmonella,Establishments do not have to hold product or recall product based on results of the,Salmonella,samples,Salmonella,Samples are taken in sets and the results of an entire set are used to determine if an establishment is meeting the performance standard,Failure to meet,Salmonella,performance standards is based on whether or not a,set,passes, not on individual sample results,Salmonella,Class of,Product,Performance,Standard (max % positive),Number of,Samples Tested,Maximum Number of Positives Allowed,Broilers,20.0%,51,12,Ground,Chicken,44.6%,53,26,Ground,Turkey,49.9%,53,29,Salmonella,Samples are collected by FSIS personnel at an unannounced time each day the product is produced until enough samples have been taken and analyzed to constitute a set of samples,Broiler samples are collected at the end of the chiller or drip line or at the last readily accessible point prior to packing or cut-up,Once collected, samples are sent to a FSIS laboratories for testing,Salmonella,Salmonella,test results only show the presence of the organism, not the number of organisms,If any,Salmonella,is found in the sample, the test result is positive,Salmonella,FSIS personnel collect,Salmonella,samples in accordance with the step-by-step directions found in FSIS Directive 10,230.5,Test results are analyzed by the FSIS Office of Public Health and Science,Salmonella,Sets are described using the following terms:,Set A is the first set of samples taken in a plant or one taken when the previous set passed,Set B is the set of samples taken after failure of one set (Set A) immediately prior to this set,Set C is the set of samples taken when two consecutive sets (Sets A and B) have failed,Salmonella,Set A failure,Enforcement actions are taken after the failure of Set A requiring that the establishment take immediate action to meet the standards,Includes reassessment of the establishments food safety system,Collection of Set B begins immediately after an establishment completes corrective and preventive actions or within 60 days of the end of Set A,Salmonella,Set B failure,The establishment is required to reassess its food safety system by reassessing its HACCP and SSOP plans,Special FSIS personnel visit the facility to assess the food safety system,Collection of samples for Set C begins immediately after an establishment completes corrective and preventive actions or within 90 days of the end of Set B,Salmonella,Set C failure,Upper level FSIS personnel will focus on the reassessments, corrective and preventive measures and on whether there is a basis to find that the establishments total food safety program is not adequate,Salmonella,Set C failure,Failure to meet the standard on the third consecutive series of FSIS-conducted tests for that product constitutes failure to maintain sanitary conditions and failure to maintain an adequate HACCP plan,Will cause FSIS to suspend inspection services,
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