Establishments producing ready-to-eat roast beef, cooked beef and corned beef products and certain ready-to-eat poultry products are required by FSIS to meet the lethality performance standards for the reduction of Salmonella contained in §§ 318.17(a)(1) and 381.150(a)(1) of the meat and poultry inspection regulations. Further, FSIS requires meat and poultry establishments, if they are not operating under a HACCP plan, to demonstrate how their processes meet these lethality performance standards within a written process schedule validated for efficacy by a process authority (§§ 318.17(2)(b)and (c) and 381.150 (2)(c) and (d)).
To assist establishments in meeting the lethality requirements, FSIS is issuing these compliance guidelines, which are based upon the time/temperature requirements contained in previous regulations. Establishments may choose to employ these guidelines as their process schedules. FSIS considers these guidelines, if followed precisely, to be validated process schedules, since they contain processing methods already accepted by the Agency as effective.
Also within these guidelines, FSIS has provided discussion regarding disposition of product following heating deviations and advice for the development of customized procedures for meeting the lethality performance standards.
1. Cooked beef and roast beef, including sectioned and formed roasts, chunked and formed roasts, and cooked corned beef can be prepared using one of the following time and temperature combinations to meet either a 6.5-log10 or 7-log10 reduction of Salmonella. The stated temperature is the minimum that must be achieved and maintained in all parts of each piece of meat for a least the stated time:
Minimum Internal Minimum processing time in Temperature minutes or seconds after minimum temperature is reached Degrees Degrees 6.5-log10 7-log10 Fahrenheit Centigrade Lethality Lethality 130 54.4 112 min. 121 min. 131 55.0 89 min. 97 min. 132 55.6 71 min. 77 min. 133 56.1 56 min. 62 min. 134 56.7 45 min. 47 min. 135 57.2 36 min. 37 min. 136 57.8 28 min. 32 min. 137 58.4 23 min. 24 min. 138 58.9 18 min. 19 min. 139 59.5 15 min. 15 min. 140 60.0 12 min. 12 min. 141 60.6 9 min. 10 min. 142 61.1 8 min. 8 min. 143 61.7 6 min. 6 min. 144 62.2 5 min. 5 min. 145 62.8 4 min.* 4 min.* 146 63.3 169 sec. 182 sec. 147 63.9 134 sec. 144 sec. 148 64.4 107 sec. 115 sec. 149 65.0 85 sec. 91 sec. 150 65.6 67 sec. 72 sec. 151 66.1 54 sec. 58 sec. 152 66.7 43 sec. 46 sec. 153 67.2 34 sec. 37 sec. 154 67.8 27 sec. 29 sec. 155 68.3 22 sec. 23 sec. 156 68.9 17 sec. 19 sec. 157 69.4 14 sec. 15 sec. 158 70.0 0 sec.** 0 sec.** 159 70.6 0 sec.** 0 sec.** 160 71.1 0 sec ** 0 sec.**
2. Cooked beef, including sectioned and formed roasts and chunked and formed roasts, and cooked corned beef should be moist cooked throughout the process or, in the case of roast beef or corned beef to be roasted, cooked as in paragraph (3) of this compliance guide. The moist cooking may be accomplished by placing the meat in a sealed, moisture impermeable bag, removing the excess air, and cooking; by completely immersing the meat, unbagged in water throughout the entire cooking process; or by using a sealed oven or steam injection to raise the relative humidity above 90 percent throughout the cooking process.
* Past regulations have listed the minimum processing time for roast beef cooked to 145°F as "Instantly." However, due to their large size, most of these roasts dwell at 145°F, or even at higher temperatures, for at least 4 minutes after the minimum internal temperature is reached. FSIS has revised this time/temperature table to reflect this and emphasizes that, to better ensure compliance with the performance standard, establishments should ensure a dwell time of at least 4 minutes if 145°F is the minimum internal temperature employed.
**The required lethalities are achieved instantly when the internal temperature of a cooked meat product reaches 158°F or above.
3. Roast beef or corned beef to be roasted can be cooked by one of the following methods:
4. Establishments producing cooked beef, roast beef, or cooked corned beef should have sufficient monitoring equipment, including recording devices, to assure that the time (accuracy assured within 1 minute), the temperature (accuracy assured within 1 °F), and relative humidity (accuracy assured within 5 percent) limits of these processes are being met. Data from the recording devices should be made available to FSIS program employees upon request.
1. Cooked poultry rolls and other cooked poultry products should reach an internal temperature of at least 160 °F prior to being removed from the cooking medium, except that cured and smoked poultry rolls and other cured and smoked poultry should reach an internal temperature of at least 155 °F prior to being removed from the cooking medium. Cooked ready-to-eat product to which heat will be applied incidental to a subsequent processing procedure may be removed from the media for such processing provided that it is immediately fully cooked to the 160 °F internal temperature.
2. Establishments producing cooked poultry rolls and other cooked poultry products should have sufficient monitoring equipment, including recording devices, to assure that the temperature (accuracy assured within 1 °F) limits of these processes are being met. Data from the recording devices should be made available to FSIS program employees upon request.
Determining the appropriate disposition of products following heating deviations can be even more difficult than determining the disposition of product after a cooling deviation. Heating deviations, which most often involve slow come-up time or an inordinate dwell time within the optimum temperature range for microorganism growth, can foster the multiplication of many pathogens. This multiplication sometimes can be so prodigious that even recooking may be ineffective in rendering the product safe. Also, certain toxigenic bacteria can release toxins into the product. Some of these toxins, such as those of Staphylococcus aureus, are extremely heat stable and are not inactivated by normal recooking temperatures.
Further, the sampling of product following a heating deviation may not yield sufficient information to determine the safety of the product in question. Heating deviations can favor the multiplication of many types of bacteria. It would be difficult and expensive to sample for all of them.
Depending on the circumstances, establishments may want to use computer modeling to estimate the relative multiplication of bacteria. For example, in a past incident involving an extreme heating deviation, product was put in an oven in which the temperature was inadvertently set to 95°F for about 12 hours. Computer modeling was easily applied in this case because much of the dwell time was at one temperature. The Agency determined that within a 6 hour time frame (with other growth conditions assumed to be favorable), the relative multiplication of many pathogens of concern could have exceeded five logs. Clearly the product could not be salvaged by reprocessing and was therefore destroyed.
Under changing conditions of temperature, however, computer modeling becomes more difficult. One approach is to average lag/log times over small increments such as 5° and add these times to get an approximation of possible total relative growth over a larger increment of time. Establishments must keep in mind that the population of bacteria before processing is generally unknown and that assumptions in the high range often are used as input parameters in the modeling.
Establishments should ultimately rely upon the expertise of a processing authority to determine the severity of heating deviations and subsequent appropriate disposition of the product in question. Dwell times of greater than 6 hours in the 50°F to 130°F range should be viewed as especially hazardous, as this temperature range can foster substantial growth of many pathogens of concern. And, a knowledge of the specific product and factors that would favor or inhibit the growth of various bacteria is essential.
The Microbial Food Safety Research Unit of the Eastern Regional Research Center, USDA Agriculture Research Service, has developed a bacterial pathogen modeling program. Entitled "Pathogen Modeling Program-Version 5.1 for Windows," it is available on the Internet from http://www.arserrc.gov. Other programs may be available commercially.
Although compliance with these guidelines will yield product that meets the lethality performance standards, some establishments may want to develop customized processing procedures that meet the codified lethality performance standards: 6.510 log of Salmonella in ready-to-eat beef products and 7 log10 in ready-to-eat poultry products. Establishments also may want to develop and implement processes using alternative lethalities. Keep in mind, however, that all processes also must achieve, throughout the product, an appropriate reduction of other pathogens of concern and their toxins or toxic metabolites.
Establishments or their process authorities may develop customized procedures or alternative lethalities that meet the performance standards by using information obtained from the literature and/or by comparing their methods with established processes. However, statistical calculations on results obtained from sampling alone are not sufficient to demonstrate that product satisfies reduced initial product conditions or that product meets the performance standards. Rather, the demonstration should be based on scientific rationale, supported by experimental data.
One of the most definitive tools at the disposal of an establishment or processing authority is the challenge study. Although challenge studies must be conducted in the laboratory rather than the establishment, they should be designed and conducted to accurately simulate the commercial process. Challenge studies should be undertaken by individuals who have a thorough knowledge of laboratory methods used in salmonellae research. A cocktail of various serotypes of Salmonella should be used in an inoculated pack study to demonstrate that the lethality performance standard is met. Relatively heat resistant pathogenic strains should be included in the cocktail to develop a worst case. The serotypes/strains selected should be among those that have been historically implicated in an appreciable number of outbreaks.
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