[Federal Register: May 26, 2005 (Volume 70, Number 101)]
[Rules and Regulations]               
[Page 30331-30334]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26my05-2]                         


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DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Part 417

[Docket No. 04-042N]

 
HACCP Plan Reassessment for Mechanically Tenderized Beef Products

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Compliance with the HACCP system regulations and request for 
comments.

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SUMMARY: The Food Safety and Inspection Service (FSIS) is publishing 
this notice to inform establishments that produce mechanically 
tenderized beef products that their next annual HACCP plan reassessment 
for these products must take into account the fact that there have been 
three relatively recent Escherichia coli (E. coli) O157:H7 outbreaks 
associated with consumption of mechanically tenderized beef. This 
requirement applies to HACCP plan reassessments for raw and cooked 
mechanically tenderized beef products, including such products that are 
injected with marinade (or ``enhanced'' products). One outbreak that 
was associated with consumption of mechanically tenderized beef 
occurred in August 2000, one in June 2003, and one in August 2004.
    The occurrence of these outbreaks represents a change that would 
affect the hazard analysis and could alter the HACCP plans of 
establishments that produce mechanically tenderized beef products. 
Therefore, establishments that produce such products should consider 
the significance of the outbreaks and ensure that their HACCP plans 
adequately address relevant biological hazards, particularly E. coli 
O157:H7. If an establishment that produces mechanically tenderized beef 
products has already considered the significance of the three outbreaks 
as part of a HACCP plan reassessment, it need not repeat this effort. 
An establishment that has already conducted its 2005 reassessment for 
mechanically tenderized beef products and has not yet considered the 
significance of the three outbreaks as part of a HACCP plan 
reassessment should do so as part of its 2006 annual HACCP plan 
reassessment. FSIS invites comments on this notice.

DATES: The Agency must receive comments by July 25, 2005.

ADDRESSES: FSIS invites interested persons to submit comments on this 
notice. Comments may be submitted by any of the following methods:
     Mail, including floppy disks or CD-ROM's, and hand- or 
courier-delivered items: Send to Docket Clerk, U.S. Department of 
Agriculture, Food Safety and Inspection Service, 300 12th Street, SW., 
Room 102, Cotton Annex, Washington, DC 20250.
    All submissions received must include the Agency name and docket 
number 04-042N.
    All comments submitted in response to this notice, as well as 
research and background information used by FSIS in developing this 
document, will be available for public inspection in the FSIS Docket 
Room at the address listed above between 8:30 a.m. and 4:30 p.m., 
Monday through Friday. The comments also will be posted on the Agency's 
Web site at http://www.fsis.usda.gov/regulations_&_policies/2005_Notices_Index/index.asp
.


FOR FURTHER INFORMATION CONTACT: Lynn Dickey, Director, Regulations and 
Petitions Policy Staff, Office of Policy, Program, and Employee 
Development, FSIS, U.S. Department of Agriculture, 1400 Independence 
Avenue, SW., Room 405, Cotton Annex, Washington, DC 20250-3700, (202) 
720-5627.

SUPPLEMENTARY INFORMATION: 

Background

    FSIS administers a regulatory program under the Federal Meat 
Inspection Act (FMIA) (21 U.S.C. 601 et seq.) to protect the health and 
welfare of consumers by preventing the distribution in commerce of meat 
products that are adulterated or misbranded. In pursuit of its goal of 
reducing the risk of foodborne illness from meat products to the 
maximum extent possible, FSIS issued final regulations on July 25, 
1996, that mandated the development and implementation of Pathogen 
Reduction and Hazard Analysis and Critical Control Point (HACCP) 
Systems by federally inspected establishments (61 FR 38806). These 
regulations require that federally inspected establishments take 
preventive and corrective measures at each stage of the food production 
process where food safety hazards occur. The HACCP regulations (9 CFR 
417.2(a)) require establishments to conduct a hazard analysis to 
determine what food safety hazards are reasonably likely to occur in 
the production process of particular products and to identify the 
preventive measures that the establishment can apply to control those 
hazards.
    Section 417.2(a)(1) of the HACCP regulations states that a food 
safety hazard that is reasonably likely to occur is one for which a 
prudent establishment would establish control measures because the 
hazard historically has occurred, or because there is a reasonable 
possibility that it will occur in the particular type of product being 
processed, in the absence of those controls. Whenever a hazard analysis 
reveals that one or more hazards are reasonably likely to occur in the 
production process, the regulations require that the establishment 
develop and implement a written HACCP plan that includes specific 
control measures for each hazard identified (9 CFR 417.2(b)(1) and 
(c)).
    Section 417.4(a)(3) of the regulations requires that every 
establishment reassess the adequacy of its HACCP plan at least annually 
and whenever any changes occur that could affect the hazard analysis or 
alter the HACCP plan. Because the outbreaks discussed in this notice 
are the first known outbreaks associated with consumption of 
mechanically tenderized beef products, and because there have been 
three outbreaks, the occurrence of these E. coli O157:H7 outbreaks is a 
change that could affect the hazard analysis or alter the HACCP plans 
for such products.

FSIS' Actions To Address E. coli O157:H7

    In 1994, FSIS notified the public that raw ground beef products 
contaminated with E. coli O157:H7 are adulterated within the meaning of 
the FMIA (21 U.S.C. 601(m)(1)) unless the ground beef is further 
processed to destroy this pathogen. The public health risk presented by 
beef products contaminated with E. coli O157:H7 is not limited, 
however, to raw ground beef products. In the January 19, 1999, Federal 
Register, FSIS explained that if non-intact beef products, including 
beef that has been mechanically tenderized by needling or cubing, are 
found to be contaminated with E. coli O157:H7, they must be processed 
into ready-to-eat product, or they would be deemed to be adulterated 
(64 FR 2803).
    In the October 7, 2002, Federal Register, FSIS informed 
manufacturers of raw beef products, including manufacturers of 
mechanically tenderized raw beef products, that they were required to 
reassess their HACCP plans, in light of certain scientific data on E. 
coli O157:H7, to determine whether E. coli O157:H7 contamination was a 
hazard reasonably likely to occur in their production process (67 FR 
62325). The data discussed in that Federal Register provided evidence 
that E. coli O157:H7 was more prevalent than was thought before the 
data became available, and that this pathogen may be a hazard 
reasonably likely to

[[Page 30332]]

occur at all stages of handling raw beef products (67 FR 62328).
    Although FSIS previously informed establishments producing 
mechanically tenderized raw beef products that they were required to 
reassess their HACCP plans based on the availability of specific 
scientific data related to the prevalence of E. coli O157:H7, only one 
outbreak (the 2000 outbreak discussed below) associated with such 
product had occurred at the time these establishments conducted their 
HACCP plan reassessments. In addition, FSIS has not previously required 
establishments that produce cooked mechanically tenderized beef 
products to reassess their HACCP plans to ensure that these HACCP plans 
adequately address biological hazards, particularly E. coli O157:H7.

E. coli O157:H7 Outbreaks Associated With Mechanically Tenderized Beef

    In August 2004, the Colorado Department of Public Health and 
Environment (CDPHE) confirmed by culture tests four E. coli O157:H7 
cases with matching Pulse-Field Gel Electrophoresis (PFGE) patterns in 
the Denver, Colorado, metropolitan area. The CDPHE determined that the 
individuals who became ill in this outbreak ate a tenderized, marinated 
beef steak product at four separate locations of a national restaurant 
chain. The CDPHE conducted an age and sex-matched case-control study 
that showed that consumption of this particular steak product was the 
only commonality of those who became ill. Although the CDPHE did not 
test product for E. coli O157:H7, the case-control study provided 
strong evidence that consumption of this product was associated with 
the outbreak. The producing establishment voluntarily recalled 
approximately 406,000 pounds of product. Information on this recall can 
be found on the FSIS web page (http://www.fsis.usda.gov), through the 

``FSIS Recalls'' link, under recall case number 033-2004.
    In June 2003, State health departments confirmed by culture tests 
eleven E. coli O157:H7 cases in five States: Seven cases in Minnesota, 
one case in Michigan, one case in Kansas, one case in Iowa, and one 
case in North Dakota. The cases were a two-enzyme PFGE pattern match. 
Based on the food intake histories of the persons who became ill, the 
State health departments epidemiologically linked all cases to a 
tenderized beef steak product (a boneless beef filet bacon-wrapped 
steak product injected with marinade). The Michigan Department of 
Agriculture Laboratory analyzed one sample of product associated with 
the outbreak and found it positive for E. coli O157:H7. The Minnesota 
Departments of Agriculture and Health Laboratories analyzed five 
samples of the product associated with the outbreak and found them 
positive for E. coli O157:H7. The product samples analyzed matched the 
two-enzyme PFGE pattern of the outbreak cases. The food histories of 
the persons who became ill, and the fact that the PFGE patterns in the 
product samples analyzed matched the outbreak cases, provided strong 
evidence that consumption of the tenderized steak product was 
associated with the outbreak.
    At the time of the outbreak, the establishment that produced the 
tenderized beef steak product was thoroughly breaking down, cleaning, 
and sanitizing its injectors only once per week. The establishment 
subsequently documented a revised plan in its Sanitation Standard 
Operating Procedures (SOPs) to break down, clean, and sanitize its 
injection needles, tenderizing needles, and associated processing 
equipment on a daily basis. Also, after changing its Sanitation SOPs, 
the establishment incorporated in its production process an 
antimicrobial treatment of the product prior to the tenderizing and 
marinating process.
    The establishment that had produced the product linked to the 2003 
outbreak voluntarily recalled approximately 739,000 pounds of product. 
Information on this recall can be found on the FSIS web page (http://www.fsis.usda.gov
), through the ``FSIS Recalls'' link, under recall 

case number 028-2003.
    From information obtained from the Centers for Disease Control and 
Prevention and State health departments, FSIS identified another 
outbreak that was associated with the consumption of mechanically 
tenderized steaks. In August 2000, the Michigan Department of Community 
Health (MDCH) laboratory identified two human isolates of a distinct 
strain of E. coli O157:H7 with matching PFGE patterns. This strain had 
not been previously found in Michigan.
    Local health departments obtained case histories from both of the 
persons who had become ill. The only similar possible exposure to the 
pathogen for the two individuals was a steak meal consumed by each on 
August 12, 2000, at different locations of a local restaurant 
steakhouse chain. Each individual had eaten a sirloin steak cooked to 
order with a red or pink center. The sirloin steaks were needle 
tenderized. The investigation of this matter suggested that the sirloin 
steak eaten by each person was likely the common source of the distinct 
strain of E. coli O157:H7 associated with these individuals' illnesses. 
The fact that both of the ill persons consumed an identical restaurant 
meal on the same day and had the onset of symptoms on the same date 
indicated that consumption of the tenderized beef steak product was 
associated with the illnesses. As a result of this investigation, the 
supplier of the steaks agreed to procedural changes in its operations, 
including sanitizing the needle-piercing machine used and testing its 
beef for E. coli O157:H7.

Reassessment in Response to Outbreaks

    The E. coli O157:H7 outbreaks discussed above that were associated 
with consumption of mechanically tenderized beef products are events 
that could alter the hazard analysis, and ultimately the HACCP plan, of 
any establishment that produces mechanically tenderized beef products. 
Therefore, as part of their next annual HACCP plan reassessment for 
such products, establishments that produce raw or cooked mechanically 
tenderized beef products (with or without marinade), hereafter referred 
to as mechanically tenderized beef products, must take into account the 
E. coli O157:H7 outbreaks discussed above to determine whether their 
HACCP plans for these products adequately address biological hazards, 
particularly E. coli O157:H7. Establishments that produce mechanically 
tenderized beef products that have already taken these three outbreaks 
into account in a HACCP plan reassessment for these products are not 
required to consider these outbreaks in their next annual HACCP plan 
reassessment, provided the establishments have evidence of their 
reassessment in their hazard analysis or HACCP plans, or a record of 
reassessment, and make this evidence available to FSIS inspection 
program personnel.
    When conducting a reassessment that takes these outbreaks into 
account to determine whether HACCP plans for mechanically tenderized 
beef products adequately address biological hazards, E. coli O157:H7 in 
particular, establishments may need to evaluate the adequacy of any E. 
coli O157:H7 interventions applied to the products' source materials. 
If they have not already done so, establishments producing mechanically 
tenderized beef products may wish to consider implementing purchase 
specifications that require that incoming product has been treated to 
eliminate or reduce E. coli O157:H7 to an undetectable level. If 
establishments producing mechanically tenderized beef products require 
their

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suppliers to meet such purchase specifications, they should also ensure 
that their suppliers actually meet these purchase specifications. 
Establishments could incorporate such purchase specifications in their 
HACCP plans, in their Sanitation SOPs, which FSIS has recognized as 
prerequisites for HACCP, or in other prerequisite programs.
    Establishments producing mechanically tenderized beef products 
might also consider applying an allowed antimicrobial agent to the 
surface of the product prior to processing or tenderization. FSIS has 
made available on its web site a document entitled, ``Guidance on 
Ingredients and Sources of Radiation Used to Reduce Microorganisms on 
Carcasses, Ground Beef, and Beef Trimmings.'' This document provides 
guidance on the use of antimicrobials on beef products. A link to the 
document is found with the October 7, 2002, Federal Register notice 
entitled, ``E. coli O157:H7 Contamination of Beef Products,'' on the 
``Interim and Final Rules'' page of FSIS' web site http://www.fsis.usda.gov/Regulations_&_Policies/2002_Interim_&_Final_Rules_Index/index.asp
.

    When conducting their reassessment, establishments producing 
mechanically tenderized beef products should consider the number of 
times tenderizers pass through the product. In addition, they should 
evaluate the adequacy of their sanitation procedures for mechanical 
tenderizers, including needles, and for associated processing 
equipment, including reservoirs and piping associated with the 
tenderizing and enhancing operations. Because tenderizers pass through 
the product, they may introduce biological hazards, including E. coli 
O157:H7, into the interior of the product. Therefore, sanitation 
procedures are particularly important in the production of mechanically 
tenderized beef products. Thus, Sanitation SOPs, other prerequisite 
programs, or HACCP plans should address procedures that ensure that all 
mechanical tenderizers and associated processing equipment are cleaned 
on a regular basis to minimize the potential for translocating E. coli 
O157:H7 from the exterior surface of the product to the interior and to 
minimize the potential for cross contamination within and among lots of 
production.
    Establishments producing raw, mechanically tenderized beef products 
might also consider including cooking instructions, in addition to 
required safe handling instructions (e.g., cook to at least 140 degrees 
F), on packages of raw, mechanically tenderized beef products, or other 
labeling, to ensure that these products are cooked adequately to 
destroy E. coli O157:H7, should it be present. Such cooking 
instructions, or other labeling, however, cannot serve as a control or 
critical control point (CCP) to address E. coli O157:H7 in the 
production process of raw, mechanically tenderized beef products.
    FSIS itself is considering requiring that raw, mechanically 
tenderized products be labeled to indicate that they have undergone 
mechanical tenderization, that the product is non-intact, and that it 
should be cooked to an adequate internal temperature to destroy any 
pathogens that may have been translocated from the surface of the 
product to the interior. Although the Federal meat and poultry products 
inspection regulations require that any marinade injected in a product 
be listed as an ingredient on the product's label, they do not require 
that product be labeled to indicate that it has been mechanically 
tenderized, and it is not possible to discern visually whether product 
has been mechanically tenderized.
    Finally, establishments producing cooked mechanically tenderized 
beef products may need to consider whether their cooking procedures are 
adequate to destroy E. coli O157:H7, should it be present. Information 
on a study concerning the effects of cooking on E. coli O157:H7 in 
blade tenderized steaks is included in the following section of this 
document.
    This section also includes information on published studies 
concerning bacteria other than E. coli O157:H7 in the interior of 
mechanically tenderized beef. In addition, it provides information on 
guidelines developed by industry associations regarding pathogen 
control in mechanically tenderized and enhanced beef products.

Research and Guidance on the Production of Mechanically Tenderized Beef 
Products

    FSIS asked the National Advisory Committee on Microbiological 
Criteria for Foods (NACMCF) to answer several questions with regard to 
E. coli O157:H7 in mechanically tenderized beef. NACMCF met on August 
3, 2001, and January 23, 2002, to discuss these questions. A report on 
NACMCF's responses to FSIS'' questions is available on the Internet at 
http://www.fsis.usda.gov/OPHS/NACMCF/2002/rep_blade1.htm. The report 

is entitled, ``Escherichia coli O157:H7 in Blade-tenderized, Non-intact 
Beef'' (updated September 9, 2002).
    FSIS asked NACMCF whether non-intact, blade tenderized beef steaks 
present a greater risk to consumers from E. coli O157:H7 compared to 
intact beef steaks, if prepared similarly to intact beef steaks. Based 
on information from a Master's thesis (Sporing, 1999), NACMCF concluded 
that non-intact, blade tenderized beef steaks do not present a greater 
risk to consumers from E. coli O157:H7 than intact beef steaks if the 
blade tenderized beef steak is oven broiled and cooked to an internal 
temperature of 140 degrees F or above. However, NACMF concluded that 
blade tenderized beef steaks present a greater risk from E. coli 
O157:H7 than intact beef steaks, particularly to immuno-compromised 
individuals, when served very rare with cold spots (less than 120 
degrees F internal temperature).
    FSIS also asked NACMCF whether non-intact, blade tenderized beef 
roasts present a greater risk to consumers from E. coli O157:H7 
compared to intact beef roasts, if prepared similarly to intact beef 
roasts. NACMCF concluded that there were insufficient data to answer 
this question adequately.
    Finally, FSIS asked NACMCF whether available evidence supports the 
need for a labeling requirement to distinguish between intact and non-
intact products in order to enhance public health protection. Again, 
NACMCF concluded that there were insufficient data to make a response 
to this question at the time the committee met. The NACMCF report lists 
research needs at the end of the document.
    Participants at the 2004 Conference of Food Protection discussed 
the handling of blade tenderized steaks at retail facilities and 
restaurants. Participants discussed the fact that blade tenderized 
products typically are not labeled to indicate that the products have 
been tenderized. They considered data from the Master's thesis that 
NACMCF reviewed (Sporing, 1999). These data showed that 3 to 4 percent 
of the surface bacterial load of blade tenderized beef steaks is 
transferred to the interior of the product. According to the thesis, 
among three methods of preparation--oven cooking, commercial grilling, 
and skillet cooking--skillet cooking provided the least effective and 
most variable reduction in E. coli O157:H7.
    Participants in the 2004 Conference for Food Protection recommended 
that the Food and Drug Administration (FDA) and USDA work together to 
develop guidance for retail facilities and restaurants on the safe 
cooking of blade tenderized steaks and other non-intact steaks. The 
participants recommended that this guidance be included in the Annex of 
the Food Code, and that FDA and USDA submit this guidance at the 2006 
Conference for Food Protection.

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FDA and USDA intend to prepare this guidance.
    Several articles in peer-reviewed journals discuss studies on the 
penetration of bacteria other than E. coli O157:H7 into the interior of 
mechanically tenderized beef products. For example, one study 
concerning salmonellae inoculated in beef rounds found that mechanical 
tenderization increased the level of salmonellae in core samples by 
about 1 logarithm, that dripping inoculated rounds into a 50 parts per 
million (ppm) chlorine solution did not prevent the occurrence of 
salmonellae in core samples of mechanically tenderized units, and that 
Salmonella survived in the core and on the surface of some, but not 
all, inoculated rounds cooked to an internal temperature of 130 degrees 
F (``The Effect of Mechanical Tenderization on Beef Rounds Inoculated 
with Salmonellae,'' Johnson, R.W.; Harris, M.E., and Moran, A.B., 
Journal of Food Safety. 1978; 1(3): 201-209; 9 ref.).
    In another study, samples of mechanically tenderized beef were 
subjected to enumeration of aerobes, coliforms, E. coli, and organisms 
that formed black or grey on Harlequin TM agar (a medium formulated for 
recovery of Listeria). The study concluded that cooking mechanically 
tenderized beef to a medium rare condition may be adequate for ensuring 
the microbiological safety of this product, provided it is devoid of 
excessive contamination of deep tissues (``Microbiological Conditions 
for Mechanically Tenderized Beef Cuts Prepared at Four Retail Stores,'' 
Gill, C.O.; McGinnis, J.C., International Journal of Food Microbiology. 
2004; 95(1): 95-102).
    Another study found that cleaning and sanitizing the tenderizer 
with an iodine-based sanitizer (25 ppm titratable iodine) decreased the 
bacterial levels of mechanically tenderized rounds (``Microbial Aspects 
of Mechanical Tenderization of Beef,'' Raccah, M.; Henrickson, R.L., 
Journal of Food Protection. 1979. 42(12): 971-973; 20 ref.).
    Several industry associations (the American Meat Institute, the 
National Cattlemen's Beef Association, the National Meat Association, 
and the Southwest Meat Association) have developed guidelines to 
address pathogen control in mechanically tenderized beef products and 
enhanced beef products. These guidelines are currently available on the 
Internet, on the Beef Industry Food Safety Council Web site at http://www.bifsco.org/BestPractices.aspx.
 The guidelines present recommended 

practices throughout tenderizing or enhancing operations and during 
cleaning and sanitizing operations.

FSIS Actions To Enforce and Facilitate Compliance with the Reassessment 
Requirement

    The Agency intends to instruct its inspection program personnel to 
determine whether establishments have considered the significance of 
the three outbreaks discussed in this notice as part of an annual HACCP 
plan reassessment for mechanically tenderized beef products. FSIS will 
also instruct inspection program personnel to ensure that all 
establishments producing mechanically tenderized beef products, 
including small and very small establishments that may not belong to a 
trade association, are aware that the Agency has issued this notice. 
Finally, FSIS intends to instruct its inspection program personnel to 
collect data concerning the outcomes of the required reassessment.

Paperwork Reduction Act

    FSIS has reviewed the paperwork and recordkeeping requirements in 
this notice in accordance with the Paperwork Reduction Act and has 
determined that the paperwork requirements for the regulations that 
require establishments that produce mechanically tenderized beef 
products to reassess their HACCP Plans have already been accounted for 
in the Pathogen Reduction/HACCP Systems information collection approved 
by the Office of Management and Budget (OMB). The OMB approval number 
for the Pathogen Reduction/HACCP Systems information collection is 
0583-0103.

Additional Public Notification

    Public awareness of all segments of rulemaking and policy 
development is important. Consequently, in an effort to ensure that the 
public and in particular minorities, women, and persons with 
disabilities, are aware of this notice, FSIS will announce it on-line 
through the FSIS web page located at http://www.fsis.usda.gov/regulations__&__policies/2005__Notices__Index/index.asp
.

    FSIS also will make copies of this Federal Register publication 
available through the FSIS Constituent Update, which is used to provide 
information regarding FSIS policies, procedures, regulations, Federal 
Register notices, FSIS public meetings, recalls, and other types of 
information that could affect or would be of interest to our 
constituents and stakeholders. The update is communicated via Listserv, 
a free e-mail subscription service consisting of industry, trade, and 
farm groups, consumer interest groups, allied health professionals, 
scientific professionals, and other individuals who have requested to 
be included. The update also is available on the FSIS web page. Through 
Listserv and the web page, FSIS is able to provide information to a 
much broader, more diverse audience.
    In addition, FSIS offers an email subscription service which 
provides an automatic and customized notification when popular pages 
are updated, including Federal Register publications and related 
documents. This service is available at http://www.fsis.usda.gov/news_and_events/email_subscription/
 and allows FSIS customers to sign up 

for subscription options in eight categories. Options range from 
recalls to export information to regulations, directives and notices. 
Customers can add or delete subscriptions themselves and have the 
option to password protect their account.

    Done at Washington, DC on: May 20, 2005.
Barbara J. Masters,
Acting Administrator.
[FR Doc. 05-10471 Filed 5-25-05; 8:45 am]