Processed Meat and Poultry Performance Standards _________________ Lethality and Stabilization Daniel Engeljohn USDA, FSIS May 9, 2001 All current FSIS policy documents, including proposed and final regulations, are available at the FSIS website at: www.fsis.usda.gov/oppde/rdad/publications.htm The FSIS docket room is open to the public Monday through Friday, 8:30am to 4:30pm. The docket room contains copies of current proposed and final regulations and associated public comments. The location is: 300 12th Street, S.W., Room 102, Washington, DC 20250-3700 Questions regarding FSIS proposed and final regulations should be directed to the Regulations and Directives Development Staff at: 300 12th Street, S.W., Room 112, Washington, DC 20250-3700 Phone: 202-720-5627 Fax: 202-690-0486 E-Mail: FSIS.regulations@usda.gov

Comment closing date extended; now due June 28, 2001 Docket Information Docket #97-013P Performance Standards for the Production of Processed Meat and Poultry Products; Proposed Rule 66 FR 12589, February 27, 2001 Comment closing date extended; now due June 28, 2001 Extension of comment period closing date: Originally closed on May 29,2001 Extended to June 28, 2001( 66 FR 19102, April 13, 2001)

Proposed Definitions Relative to Lethality 9 CFR 430.1 Fermented product Made ready-to-eat by bacterial enzymes acting to lower pH and microbial inhibition Ready-to-eat product Safe to consume without cooking or application of some other lethality treatment to destroy pathogens Worst case product Defined for lethality requirements in 9 CFR 430.2(a)(1) for meat and poultry, and in 9 CFR 430.2(b)(1) for beef Worst Case: For purposes of the lethality requirements contained in 430.2(a)(1) worst case raw poultry contains 6.7-log10 of Salmonella in any 143 gram sample worst case raw meat contains 6.2-log10 of Salmonella in any 143 gram sample For purposes of the lethality requirements contained in 430.2(b)(1) worst case raw beef contains 4.4-log10 of E. coli O157:H7 in any 143 gram sample Other definitions included in proposed 430.1 but not discussed in today’s lethality/stabilization session. See the preamble (section IV. The Proposed Performance Standards--A. Lethality) for a more complete discussion (66 FR 12592-12601).

Proposed Text for Lethality: Salmonella 9 CFR 430.2(a) Either a probability of survival No greater than the specified Salmonella organisms in any 100 grams of finished product, assuming incoming product is worst case Or a log reduction 6.5-log10 reduction for meat 7.0-log10 reduction for poultry Detectable viable Salmonella adulterate ready-to-eat product 430.2(a)(1) Processing of any meat or poultry product, except a thermally-processed, commercially sterile product, for the purpose of rendering that product ready-to-eat, must be validated to achieve probabilities no greater than the following that Salmonella organisms would remain in any 100 gram sample of finished product, assuming that incoming raw product is worse case product. >0 surviving = 39.4%; >1=9.06%; >2=1.45%; >3=0.177%; >4=0.0174% Any detectable level of viable Salmonella organisms adulterates ready-to-eat meat and poultry products. 430.2(a)(2) Official establishments that do not wish to demonstrate that their processing results in probabilities no greater than the probabilities in paragraph (a)(1) of this section may instead employ processing validated to achieve either a 6.5-log10 reduction of Salmonella throughout a finished ready-to-eat product, or, a 7.0-log10 reduction of Salmonella throughout a finished ready-to-eat product that contains any amount of poultry. See the preamble (section IV. The Proposed Performance Standards--A. Lethality) for a more complete discussion (66 FR 12592-12601).

Proposed Text for Lethality: E. coli O157:H7 9 CFR 430.2(b) Either a probability of survival No greater than the specified E. coli O157:H7 organisms in any 100 grams of finished (fermented beef) product, assuming incoming product is worse case Or a log reduction 5.0-log10 reduction for fermented meat or poultry product containing beef Detectable viable E. coli O157:H7 adulterate ready-to-eat product 430.2(b)(1) In addition to meeting the standards in paragraph (a), of this section, processing of any fermented meat or poultry product that contains any amount of beef, except a thermally-processed, commercially sterile product, for the purpose of rendering that product ready-to-eat, must be validated to achieve probabilities no greater than the following that E. coli O157:H7 organisms would remain in any 100 gram sample of finished product, assuming that incoming raw product is worse case product. >0 surviving = 22.2%; >1=2.67% Any detectable level of viable E. coli O157:H7 organisms adulterates ready-to-eat meat and poultry products. 430.2(b)(2) Official establishments that do not wish to demonstrate that their processing results in probabilities no greater than the probabilities in paragraph (b)(1) of this section may instead employ processing validated to achieve either a 5.0-log10 reduction of E. coli O157:H7 throughout a finished ready-to-eat product that contains any amount of beef. See the preamble (section IV. The Proposed Performance Standards--A. Lethality) for a more complete discussion (66 FR 12592-12601).

Proposed Text for Lethality 9 CFR 430.2(c) Reduction of other pathogens and their toxins or toxic metabolites: Validated to prevent product adulteration 9 CFR 430.2(d) Maintain the lethality performance standards throughout product shelf-life Validated under the conditions in which the food is stored, distributed, and held See the preamble (section IV. The Proposed Performance Standards--A. Lethality) for a more complete discussion (66 FR 12592-12601).

Determination of worst case levels: Lethality Used highest Most-Probable-Number (MPN) results from FSIS national microbiology baseline surveys MPN samples were frozen; samples were companion with those that tested Salmonella positive on a qualitative test Conservative assumptions were made in determining worst case levels Assumptions: MPN values adjusted for recovery Upper 97.5% confidence bounds used for statistical measured values Levels assumed to be uniformly distributed throughout 143 grams of product ( = 100 grams/0.7; assuming a 70% yield) See the preamble (section IV. The Proposed Performance Standards--A. Lethality) for a more complete discussion (66 FR 12592-12601).

For whole poultry carcasses, the high value reported was 66 MPN/cm2 For poultry products, 2300 MPN/g is used (results seen for ground product) Poultry carcasses, the measured MPN/ml of rinse was converted to MPN/cm2 using the relationship between the weight of the bird and its surface area (i.e., SA = 0.87 weight(grams) + 635). A 1500 gram carcass would have approximately 1940 cm2 For whole poultry carcasses, the high value reported was 66 MPN/cm2 For red meat products 720 MPN/g is used: The samples from the carcass baseline survey were taken from 3 sections of the carcass, so, multiply the highest MPN value (=240 MPN/cm2) by 3. Assume cut of meat is 0.8 cm and specific density of beef is about 1.1 grams/cm3, then MPN/cm2 are assumed to estimate MPN/g. For the ground red meat product, the highest level cannot be determined from >110 MPN/g result. Upper confidence bound of level in sample: Assume  is the probability that a single cell is not detected, so that if there are n cells in a sample the probability of no detection is n. The value of  was determined by assuming that 13 cells would be detected (in a 25 gram sample) with 99% probability, so that 1- n = 0.99;  = 0.70, so that the recovery is assumed to be 30%. See the preamble (section IV. The Proposed Performance Standards--A. Lethality) for a more complete discussion (66 FR 12592-12601).

Salmonella Lethality Performance Standard Safety margin: 0.3-log10 added to worst case level resulting in the performance standard: Poultry = 7.0-log10 Meat = 6.5-log10 Implies that after application of the lethality treatment on raw product containing worst case level of cells, probability of any viable cell is 39.4% Poultry products Upper 97.5% confidence bound  37,500 cells/g Multiplied by 143 grams, = 5.36 x 106 cells Approximately 6.7-log10. Red Meat products Upper 97.5% confidence bound  12,300cells/g Multiplied by 143 grams, = 1.76 x 106 cells Approximately 6.2-log10 See the preamble (section IV. The Proposed Performance Standards--A. Lethality) for a more complete discussion (66 FR 12592-12601).

E. coli O157:H7 Lethality Performance Standard for Fermented Beef Safety margin: 0.6-log10 added to worst case level resulting in the performance standard: Fermented beef = 5.0-log10 Implies that after application of the lethality treatment on fermented beef containing worst case level of cells, probability of any viable cell is 22.2% The Agency found no reason to change present practice which is based on a 5.0-log10 lethality. In about 4000 samples analyzed for the USDA microbiology baseline studies for beef carcasses, only 2 positive MPN values, with highest value of 0.93/cm2. Recovery: Eight of nine 25-gram samples of ground beef inoculated with 0.7 E. coli O157:H7 cells/g were detected as positive, so that 97.5% lower confidence bound for recovery is 6.2%. Assuming a 6.2% recovery, the upper 97.5% confidence bound for the level is about 59.5 cells/cm2; the 59.5 cells/cm2 is multiplied by 3, and then multiplied by 143 grams to derive an approximate 4.4 log10 cells for the worst case level. Foodborne illness associated with E. coli O157:H7 might be more severe than that associated with Salmonella; researchers believe that low numbers of ingested E. coli O157:H7 cells are sufficient to cause foodborne illness; there is only a small amount of data from the Agency’s microbiological baseline survey: only two MPN samples were positive. If lethality requirement were 5.5-log10 then the probability of surviving E. coli O157:H7 for the worst case product would be: 7.6%; if lethality requirement were 6.0-log10 then the probability of surviving E. coli O157:H7 for the “worst case” product would be: 2.5%. See the preamble (section IV. The Proposed Performance Standards--A. Lethality) for a more complete discussion (66 FR 12592-12601).

Proposed Text for Stabilization 9 CFR 430.3(a) Processing of all ready-to-eat meat and poultry products must prevent multiplication of toxigenic microorganisms: Clostridium botulinum Allow no more than 1.0-log10 multiplication of Clostridium perfringens 9 CFR 430.3(b) Processing of all heat treated, not ready-to-eat meat and poultry products must meet same criteria as in (a) above Clostridium botulinum: Able to form deadly toxins when multiplying Spores of these bacteria, initially present on the raw meat, can withstand heating during cooking, become heat shocked, germinate, and after a lag period, multiply as vegetative cells during cooling Clostridium perfringens: Growth rate is high Viable counts of 105 /g or greater have been recommended by the U.S. Centers for Disease Control and Prevention (1996) for incriminating C. perfringens as a possible causative agent of foodborne illness Viable counts of 106 /g or greater are usually found in foods implicated in outbreaks (National Research Council, 1985) Estimating the possible amount of vegetative cell multiplication is paramount in assessing the safety of the final product See the preamble (section IV. The Proposed Performance Standards--B. Stabilization) for a more complete discussion (66 FR 12601-12602).

Proposed Text for Stabilization 9 CFR 430.3(c) Processing of products applicable to 9 CFR 430.3(a) or (b) must be validated: to maintain stabilization performance standards throughout product shelf-life under conditions in which the food is stored, distributed, and held See the preamble (section IV. The Proposed Performance Standards--B. Stabilization) for a more complete discussion (66 FR 12601-12602).

See the preamble (section IV. The Proposed Performance Standards--B See the preamble (section IV. The Proposed Performance Standards--B. Stabilization) for a more complete discussion (66 FR 12601-12602).

Determination of worst case level: C. perfringens Used results from FSIS national microbiological baseline survey No finding greater than 105/g Worst case is assumed to be 104 C. perfringens per gram that become heat shocked, germinate, and after a lag period, multiply as vegetative cells during cooling In ground beef survey, out of 1687 samples, only one sample result was >104 /g In chicken, at 11,000/g For raw meat carcasses, out of 6313 samples analyzed, there were 10 (0.16%) results that were greater than 104 but less than 105 CFU/cm2 Distribution of C. perfringens may be highly skewed within lot; sampling may be like looking for a needle in a haystack See the preamble (section IV. The Proposed Performance Standards--B. Stabilization) for a more complete discussion (66 FR 12601-12602).

Draft Compliance Guidelines Available now: Constituent Update, May 4 FSIS Website at: www.fsis.usda.gov/OPPDE/rdad/FRPubs/RTEGuide.pdf FSIS requests comment on these Including suggestions for expansion to cover all types of ready-to-eat and partially heat-treated meat and poultry products Draft guidelines Not to be used for regulatory enforcement or compliance purposes Developed by FSIS to assist establishments in understanding the requirements of the proposed rule on performance standards for processed meat and poultry. Guidance is based on previous Agency regulations; published scientific challenge studies; and other procedures validated to achieve the performance standards. Covered ready-to-eat products include cooked, fermented, salt-cured, and dried meat and poultry products. The compliance guidelines in Appendix A and Appendix B (with the final roast beef and cooked poultry rules) are reproduced here. Of note: FSIS and ARS co-authored an article entitled “Modeling non-linear survival curves to calculate thermal inactivation of Salmonella in poultry of different fat levels” soon to be published in a scientific journal. The times within the new time/temperature combinations are significantly higher than those assumed to be effective and published in our current compliance guide (e.g., 160 degrees instantly). FSIS requests comment on these new time/temperature combinations for ready-to-eat poultry.