[Federal Register Volume 61, Number 66 (Thursday, April 4, 1996)]
[Notices]
[Pages 15024-15027]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-7938]



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DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
[Docket No. 96-002N]


Notice of Policy Change; Achieving the Zero Tolerance Performance 
Standard for Beef Carcasses by Knife Trimming and Vacuuming With Hot 
Water or Steam; Use of Acceptable Carcass Interventions for Reducing 
Carcass Contamination Without Prior Agency Approval

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Notice.

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SUMMARY: The Food Safety and Inspection Service (FSIS) is announcing a 
change to its trim-only policy for removing fecal, ingesta, and milk 
contamination from beef carcasses. Currently, all feces, ingesta, and 
milk must be physically removed from beef carcasses by knife trimming. 
Under this new policy, FSIS will permit the use of vacuuming beef 
carcasses with hot water or steam as an alternative to the trim-only 
policy for removing fecal and ingesta contamination, when such 
contamination is less than one inch in its greatest dimension.
    This notice also lists other carcass decontamination systems that 
may be used on beef carcasses during the dressing operation. These 
other interventions may not be used to remove fecal or ingesta 
contamination. They may be used in conjunction with knife trimming or 
vacuuming with hot water or steam. They may also be used without prior 
Agency approval.

FOR FURTHER INFORMATION CONTACT: Dr. William James, Director, Slaughter 
Inspection Standards and Procedures Division, Science and Technology, 
Food Safety and Inspection Service, U.S. Department of Agriculture, 
Washington, DC 20250-3700; (202) 720-3219.

SUPPLEMENTARY INFORMATION:

Background

    Effective prevention and removal of fecal and ingesta contamination 
are among the most important steps establishments must take to ensure 
the safety of beef carcasses. Such contamination may harbor Escherichia 
coli O157:H7, Salmonella, and other enteric pathogens. Given the 
association of pathogens with feces and intestinal contents, minimizing 
the exposure of carcasses to fecal and ingesta contamination and prompt 
and complete removal of such contamination is critical to food safety.
    FSIS has had a long-standing policy prohibiting visible feces or 
ingesta on inspected and passed beef carcasses. Following the 1993 
outbreak of E. coli O157:H7 food poisoning in the Western United 
States, FSIS strictly enforced the knife trim-only policy for removing 
feces and ingesta contamination from beef carcasses.
    Prior to the outbreak, warm and ambient temperature washes were 
sometimes permitted by inspectors to be used to remove small flecks of 
contaminants. However, inspection personnel did not always determine 
whether the source of the flecks on beef carcasses was fecal or ingesta 
contamination or another source, such as rail dust.
    After the 1993 outbreak of E. coli O157:H7, FSIS reiterated that 
trimming

[[Page 15025]]
was to be the only means of removing feces or ingesta contamination 
from beef carcasses. FSIS reaffirmed the trim policy based on its 
judgment that trimming was more effective for removing fecal or ingesta 
contamination than alternative approaches and the Agency's need to 
directly and aggressively remove any potential source of pathogenic 
contamination. At the time, there were no scientific data available to 
the Agency comparing the efficacy of trimming and alternative 
procedures.
    Trimming, if performed properly, is an effective means of 
physically removing from beef carcasses the visible contamination and 
any accompanying microbial contamination. A primary advantage of 
trimming over ambient temperature washing is that it physically removes 
visibly contaminated tissue (which is more likely to be 
microbiologically contaminated). Washing may not effectively remove 
bacteria which are firmly attached. Also, trimming, when properly 
performed, will have less potential than ambient temperature washing 
for spreading contamination to other parts of the carcass.
    If performed incorrectly, trimming has the potential to cause 
cross-contamination as the knife moves from areas contaminated with 
bacteria to newly exposed uncontaminated areas. The effectiveness of 
trimming depends on the skill of the operator in visually detecting and 
effectively removing contamination, while avoiding further 
contamination by handling the carcass during this process.
    Since 1993, numerous approaches to removing contamination have been 
devised and studied to assess their potential as effective alternatives 
or supplements to carcass trimming to achieve the zero tolerance 
standard. As a result, a significant amount of new scientific data has 
become available regarding alternatives to FSIS's trim-only policy for 
removing fecal and ingesta contamination.
    On September 26, 1995, FSIS published a Federal Register notice (60 
FR 49553) announcing a public meeting to consider the issue of the most 
effective means of removing visible fecal or ingesta and associated 
microbial contamination from beef carcasses. That notice, which 
indicated that FSIS was considering whether to permit additional 
methods for achieving the zero tolerance standard, provided an 
extensive review of the scientific literature on this subject. It also 
addressed conditions of animals on arrival at slaughter; sources of 
bacterial contamination during slaughter; the rate of attachment, 
growth and multiplication of bacteria on carcasses; and methods to 
decrease carcass contamination. The notice invited presentation of 
further technical data and participation in discussions on both 
technical and policy aspects of the issue. It also presented two series 
of questions addressing technical matters and policy considerations.
    Seventy-two individuals participated in the two-day public meeting. 
Twelve individuals formally presented data about existing or 
technologies under development that are proving effective in removing 
fecal and ingesta and related microbial contamination from beef 
carcasses. Specific topics discussed included steam and hot water 
vacuum systems, hot water vacuum data, methods of carcass 
decontamination, steam pasteurization, comparisons of knife trimming to 
steam and hot water vacuum treatments, carcass washing versus trimming, 
antimicrobial treatment conditioning processes, antimicrobial sprays, 
including acidified sodium chlorite solutions, the efficacy of spray-
washing on the removal of bacterial contamination and fecal material, 
and process intervention for decontamination of beef carcasses using 
physical and/or antimicrobial treatments. A literature review was also 
presented. A transcript of the two-day meeting and the papers offered 
by presenters are available from the FSIS Docket Clerk.1

    \1\ The FSIS Docket Clerk is located in Room 4352, South 
Agriculture Building, 14th & Independence Ave., SW., Washington, DC 
20250-3700.
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    While there are a number of promising interventions in various 
stages of development, the first day's presentations revealed 
laboratory data supporting the efficacy of using the steam and hot 
water vacuum technology to remove microorganisms, including pathogens 
of concern, and a considerable and growing body of data from in-plant 
trials substantiating the efficacy of this technology.
    During the second day of the public meeting, the policy questions 
in FSIS's meeting notice regarding approval of any alternatives to the 
existing trim-only requirement were discussed. By the end of the public 
meeting, a number of participants agreed to the following:
    1. In order to meet public health objectives, knife trimming should 
be combined with other effective technologies, which may include steam 
or hot water vacuuming, pre- and post-evisceration washes, 
antimicrobial treatments such as organic acids or trisodium phosphate, 
and steam pasteurization technology. The scientific data on 
decontamination of beef carcasses support a multi faceted approach.
    2. Each intervention should be scientifically validated to assure 
that specific microbiological hazards are effectively controlled.
    3. Technologies could and should be combined to meet the needs of 
individual establishments and processes.
    One particular intervention, a vacuum system incorporating hot 
water and/or steam above 180 deg.F, has been found, by the USDA's 
Agricultural Research Service, to be effective in removing fecal 
contamination (less than one inch in its greatest dimension) and 
associated bacteria, including pathogens, from beef carcasses. 
Vacuuming with hot water or steam combines physical removal of visible 
contaminants with microbial inactivation. After the hide is removed, 
carcass surface areas are treated with hot water or steam and vacuumed. 
The vacuuming removes contamination and any excess water from the 
carcass surface. The regulated industry and others have urged FSIS to 
consider these data and to change its policy accordingly; at the same 
time, others have urged FSIS to retain the trim-only policy.
    During the meeting, the USDA's Agricultural Research Service 
presented the results of laboratory tests on the effectiveness of a 
vacuum system which incorporated hot water and steam above 180 deg.F. 
These tests demonstrated a 3.3 log10 reduction in total bacterial 
counts on artificially contaminated beef tissues inoculated at a level 
of 6.4 log10 with bovine feces. When the vacuum was used on beef 
artificially inoculated at a level of 7.6 log10 with E. coli 
O157:H7, a 5.5 log10 reduction was achieved.
    Based upon these results, FSIS approved testing of vacuum systems 
under commercial conditions in more than 50 plants as a method to 
remove visible contamination and accompanying microbial contamination. 
Testing consisted of two phases.
    In Phase I, each establishment collected 120 samples over 10 days 
of production, 60 samples from vacuumed carcasses and 60 samples from 
knife-trimmed beef carcasses. Establishments were allowed to vacuum 
half of each day's production for fecal or ingesta contamination that 
was less than one inch in its greatest dimension. The remaining 
carcasses were trimmed to remove visible fecal or ingesta 
contamination. Any fecal or ingesta contamination greater than one inch 
in its greatest dimension was removed by trimming, no matter which 
treatment was being applied. This phase provided

[[Page 15026]]
a direct comparison of the microbial characteristics of vacuumed and 
knife trimmed carcasses.
    In Phase II, 60 additional samples were collected over 60 days from 
vacuumed carcasses only. This phase provided data on the ability of 
each establishment to control the vacuum process over time.
    Forty of Phase I and Phase II tests have been completed. Phase I 
data submitted to the Agency for these 40 tests show the mean of total 
bacterial levels in the different establishments was 0.69 log colony 
forming units (CFU)/cm\2\ lower on vacuumed carcasses than knife 
trimmed carcasses. Phase II results also demonstrated a 0.54 log CFU/
cm\2\ lower mean total bacterial level was maintained compared to knife 
trimmed carcasses.
    Thirty two of the establishments completing both phases used hot 
water vacuuming technology. The mean of total bacterial levels for hot 
water vacuumed carcasses was lower than trimmed carcasses in both 
phases. For Phase I, the difference was 0.64 CFU/cm\2\, and for Phase 
II it was 0.56 CFU/cm\2\. Eight establishments have completed both 
phases using steam vacuuming technology. The data from these eight 
establishments show the mean of total bacteria was 0.88 log CFU/cm\2\ 
lower for vacuumed carcasses for Phase I and 0.43 lower for Phase II.
    Phase I tests were conducted in five establishments by researchers 
from the Department of Animal Sciences, Colorado State University 
(CSU), Fort Collins, Colorado. In the study, hot water vacuuming of 
beef carcasses was as effective as knife trimming for removing visible 
contamination and reducing bacterial populations. The CSU researchers 
reported reductions of 1.38 and 1.67 log CFU/cm\2\ for mesophilic 
Aerobic Plate Counts (APC) and 1.62 and 1.67 log CFU/cm\2\ for Total 
Coliform Counts (TCC) respectively when a 103 cm\2\ area of the carcass 
was trimmed or vacuumed. (Paper to be presented at the Annual Meeting 
of the Institute of Food Technologists, New Orleans, LA, June 22-26, 
1996.)
    In another test conducted by CSU, vacuuming with steam effectively 
reduced APC and TCC on carcasses with or without visible fecal 
contamination. When feces were present, the steam vacuuming system was 
more effective in reducing microbial contamination than knife trimming 
while both were effective in removing visible contaminants. (Paper to 
be presented at the Annual Meeting of the International Association of 
Milk, Food and Environmental Sanitarians, Seattle, WA, June 30-July 3, 
1996.)
    Based on the data presented and discussion that transpired during 
the two day public meeting, FSIS has decided to modify its existing 
policy to permit an alternative method for removal of fecal and ingesta 
contamination from beef carcasses. When feces or ingesta contamination 
is less than one inch in its greatest dimension, it may be removed by 
use of a steam or hot water vacuum as an alternative to knife trimming. 
Knife trimming is required to remove feces or ingesta contamination one 
inch or larger. This size limitation and the limitation of the policy 
change to fecal and ingesta contamination reflects the conditions under 
which the steam or hot water vacuum technology was tested and found 
effective. In order to extend the policy to larger areas of 
contamination or to milk contamination, data would be required 
demonstrating the effectiveness of the technology for those purposes.
    Establishments receiving federal inspection that desire to take 
advantage of steam or hot water vacuuming for achieving the zero 
tolerance standard for fecal and ingesta contamination may do so 
immediately without prior Agency approval, provided that the equipment 
used as a steam or hot water vacuum system meets the following 
requirements:
    1. The system must provide accurate temperature and vacuum 
readings. Once the temperature and vacuum parameters are adjusted, 
before operations start, the system should work properly and steadily 
without significant reading fluctuations.
    2. Water or steam temperatures at the carcass surface must be 
maintained at a minimum of 180 deg.F. The water or steam temperature 
recording device should measure the temperature of the water or steam 
as close as possible to the carcass surface. The system must also have 
an automatic shut-off system when the temperature of the water or steam 
falls below 180 deg.F.
    3. The vacuum pressure at the carcass surface must be sufficient to 
remove the steam and water from the vacuum area to prevent dripping.
    4. The outer surface of the vacuum head must be subjected 
continuously to a minimum of 180 deg.F steam or hot water during its 
use. An alternative would be to sterilize the vacuum head in 180  deg.F 
water after each use. Other sterilization procedures may be approved by 
the inspector-in-charge.

Other Carcass Decontamination Systems

    FSIS continues to permit the use of other carcass decontamination 
systems (antimicrobial treatments) in the slaughter of beef carcasses 
during the dressing operation. This supports a multifaceted approach to 
reduce microbial contamination. The interventions listed below may be 
used by establishments without prior Agency approval. These 
interventions, which may not be used to remove visible fecal or ingesta 
contamination, may be used in conjunction with knife trimming or 
vacuuming with hot water or steam. Fecal and ingesta contamination will 
be removed prior to the use of the other interventions at appropriate 
stages of the slaughter process. These include:

    1. A pre-evisceration system which consists of a water rinse, 
followed by a rinse with a solution of food grade organic acid(s). 
The first rinse is applied as a low pressure water rinse to remove 
incidental foreign material such as hair, dirt, and rail dust and 
accompanying bacteria before they dry and become firmly attached to 
carcass tissues. The second rinse of an aqueous solution of organic 
acid(s) is applied as a mist or small droplets to all exposed 
carcass surfaces to reduce the microbial population and retard 
microbial growth. Food grade organic acids, such as acetic, lactic, 
and citric acids, which are considered by FDA to be multiple purpose 
``generally recognized as safe'' (GRAS) food substances or direct 
food substances affirmed as GRAS, may be used. FSIS approved 
automated two cabinet (carcass wash cabinet and acid sanitizing 
cabinet) systems are available and may be used to apply acids to 
beef carcasses.
    2. Organic acid treatment. As stated above, food grade FDA GRAS 
organic acids, such as acetic, lactic, and citric acid, may be used 
in an aqueous solution of 1.5-2.5 percent acid applied to skinned 
carcasses as a mist, fog, or small droplet rinse. Acid treatments 
may be used as a decontamination intervention during dressing of 
beef carcasses at any point where beef carcasses are allowed to be 
rinsed with water. FSIS approved automated acid sanitizing cabinets 
or hand operated equipment may be used to apply acids to beef 
carcasses.
    3. Chlorinated water. Chlorinated water containing 20 to 50 ppm 
chlorine may be used as an antimicrobial intervention during 
dressing of beef carcasses at any point where beef carcasses are 
rinsed with water. Chlorine sources generally recognized as safe for 
this purpose include: chlorine gas; sodium, potassium, or calcium 
hypochlorite; chlorine dioxide; or electrolytically generated 
hypochlorous acid.
    4. Trisodium phosphate (TSP). TSP applied to beef carcasses by 
spraying with a solution of water and food grade TSP containing 8 to 
12 percent TSP and maintained at a temperature of 90  deg.F to 110 
deg.F. The treatment can be applied for no more than 30 seconds. TSP 
may be used as an antimicrobial intervention during dressing of beef 
carcasses at any point where beef carcasses are rinsed with water. 
FSIS approved automated cabinets for the application of TSP are 
commercially available. The current approved cabinet

[[Page 15027]]
recirculates the TSP solution. TSP may also be applied by hand 
operated equipment.
    5. Hot water or steam. Water or steam applied to the surface of 
the carcass at a temperature greater than 165  deg.F ( 74 
 deg.C) and applied for more than 10 seconds has been demonstrated 
to be an effective antimicrobial intervention. This includes the 
Cargill/Frigoscandia Steam Pasteurization Process applied to beef. 
The equipment must meet the requirements in 9 CFR 308.5 and the 
method of application may not interfere with inspection or create a 
sanitation problem due to mist, fog, or condensation. Hot water or 
steam may be used as an intervention during dressing of beef 
carcasses at any point where beef carcasses are currently allowed to 
be rinsed with water. FSIS approved automated or hand held equipment 
may be used.
    6. Air or steam. Air or steam may be used to remove incidental 
foreign material such as hair, dirt, and rail dust, from carcasses. 
The air or steam containing the contaminants must be confined so 
that it is captured by a water curtain or exhaust system. The 
equipment must meet the requirements in 9 CFR 308.5 and the method 
of application may not interfere with inspection or create a 
sanitation problem due to mist, fog, or condensation.

    Areas of carcasses with fecal or ingesta contamination, open 
abscesses, septic bruises, parasites or parasitic lesions, or lactating 
udders will not be treated until those conditions have been removed.
    FSIS encourages the introduction of new technologies which 
demonstrably enhance food safety. FSIS believes that the data on the 
steam vacuum technology supports its use. Technologies which enhance 
food safety should be scientifically validated to assure that specific 
microbiological hazards are effectively controlled. FSIS will continue 
to encourage companies to prevent contamination, rather than relying on 
after-the-fact efforts to correct problems. Establishments must direct 
their energies at preventing such contamination.

    Done at Washington, DC, on: March 27, 1996.
Michael R. Taylor,
Acting Under Secretary for Food Safety.
[FR Doc. 96-7938 Filed 4-3-96; 8:45 am]
BILLING CODE 3410-DM-P