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Federal Register / Vol. 70, No.

101 / Thursday, May 26, 2005 / Rules and Regulations 30331

DEPARTMENT OF AGRICULTURE • Mail, including floppy disks or CD– measures because the hazard
ROM’s, and hand- or courier-delivered historically has occurred, or because
Food Safety and Inspection Service items: Send to Docket Clerk, U.S. there is a reasonable possibility that it
Department of Agriculture, Food Safety will occur in the particular type of
9 CFR Part 417 and Inspection Service, 300 12th Street, product being processed, in the absence
[Docket No. 04–042N] SW., Room 102, Cotton Annex, of those controls. Whenever a hazard
Washington, DC 20250. analysis reveals that one or more
HACCP Plan Reassessment for All submissions received must hazards are reasonably likely to occur in
Mechanically Tenderized Beef include the Agency name and docket the production process, the regulations
Products number 04–042N. require that the establishment develop
All comments submitted in response and implement a written HACCP plan
AGENCY: Food Safety and Inspection to this notice, as well as research and that includes specific control measures
Service, USDA. background information used by FSIS in for each hazard identified (9 CFR
ACTION: Compliance with the HACCP developing this document, will be 417.2(b)(1) and (c)).
system regulations and request for available for public inspection in the Section 417.4(a)(3) of the regulations
comments. FSIS Docket Room at the address listed requires that every establishment
above between 8:30 a.m. and 4:30 p.m., reassess the adequacy of its HACCP plan
SUMMARY: The Food Safety and
Monday through Friday. The comments at least annually and whenever any
Inspection Service (FSIS) is publishing
also will be posted on the Agency’s Web changes occur that could affect the
this notice to inform establishments that
site at http://www.fsis.usda.gov/ hazard analysis or alter the HACCP
produce mechanically tenderized beef
regulations_&_policies/ plan. Because the outbreaks discussed
products that their next annual HACCP
2005_Notices_Index/index.asp. in this notice are the first known
plan reassessment for these products
FOR FURTHER INFORMATION CONTACT:
outbreaks associated with consumption
must take into account the fact that
Lynn Dickey, Director, Regulations and of mechanically tenderized beef
there have been three relatively recent
products, and because there have been
Escherichia coli (E. coli) O157:H7 Petitions Policy Staff, Office of Policy,
three outbreaks, the occurrence of these
outbreaks associated with consumption Program, and Employee Development,
E. coli O157:H7 outbreaks is a change
of mechanically tenderized beef. This FSIS, U.S. Department of Agriculture,
that could affect the hazard analysis or
requirement applies to HACCP plan 1400 Independence Avenue, SW., Room
alter the HACCP plans for such
reassessments for raw and cooked 405, Cotton Annex, Washington, DC
products.
mechanically tenderized beef products, 20250–3700, (202) 720–5627.
including such products that are SUPPLEMENTARY INFORMATION: FSIS’ Actions To Address E. coli
injected with marinade (or ‘‘enhanced’’ O157:H7
products). One outbreak that was Background
In 1994, FSIS notified the public that
associated with consumption of FSIS administers a regulatory program raw ground beef products contaminated
mechanically tenderized beef occurred under the Federal Meat Inspection Act with E. coli O157:H7 are adulterated
in August 2000, one in June 2003, and (FMIA) (21 U.S.C. 601 et seq.) to protect within the meaning of the FMIA (21
one in August 2004. the health and welfare of consumers by U.S.C. 601(m)(1)) unless the ground beef
The occurrence of these outbreaks preventing the distribution in commerce is further processed to destroy this
represents a change that would affect of meat products that are adulterated or pathogen. The public health risk
the hazard analysis and could alter the misbranded. In pursuit of its goal of presented by beef products
HACCP plans of establishments that reducing the risk of foodborne illness contaminated with E. coli O157:H7 is
produce mechanically tenderized beef from meat products to the maximum not limited, however, to raw ground
products. Therefore, establishments that extent possible, FSIS issued final beef products. In the January 19, 1999,
produce such products should consider regulations on July 25, 1996, that Federal Register, FSIS explained that if
the significance of the outbreaks and mandated the development and non-intact beef products, including beef
ensure that their HACCP plans implementation of Pathogen Reduction that has been mechanically tenderized
adequately address relevant biological and Hazard Analysis and Critical by needling or cubing, are found to be
hazards, particularly E. coli O157:H7. If Control Point (HACCP) Systems by contaminated with E. coli O157:H7, they
an establishment that produces federally inspected establishments (61 must be processed into ready-to-eat
mechanically tenderized beef products FR 38806). These regulations require product, or they would be deemed to be
has already considered the significance that federally inspected establishments adulterated (64 FR 2803).
of the three outbreaks as part of a take preventive and corrective measures In the October 7, 2002, Federal
HACCP plan reassessment, it need not at each stage of the food production Register, FSIS informed manufacturers
repeat this effort. An establishment that process where food safety hazards of raw beef products, including
has already conducted its 2005 occur. The HACCP regulations (9 CFR manufacturers of mechanically
reassessment for mechanically 417.2(a)) require establishments to tenderized raw beef products, that they
tenderized beef products and has not yet conduct a hazard analysis to determine were required to reassess their HACCP
considered the significance of the three what food safety hazards are reasonably plans, in light of certain scientific data
outbreaks as part of a HACCP plan likely to occur in the production process on E. coli O157:H7, to determine
reassessment should do so as part of its of particular products and to identify whether E. coli O157:H7 contamination
2006 annual HACCP plan reassessment. the preventive measures that the was a hazard reasonably likely to occur
FSIS invites comments on this notice. establishment can apply to control those in their production process (67 FR
DATES: The Agency must receive hazards. 62325). The data discussed in that
comments by July 25, 2005. Section 417.2(a)(1) of the HACCP Federal Register provided evidence that
ADDRESSES: FSIS invites interested regulations states that a food safety E. coli O157:H7 was more prevalent
persons to submit comments on this hazard that is reasonably likely to occur than was thought before the data
notice. Comments may be submitted by is one for which a prudent became available, and that this pathogen
any of the following methods: establishment would establish control may be a hazard reasonably likely to

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30332 Federal Register / Vol. 70, No. 101 / Thursday, May 26, 2005 / Rules and Regulations

occur at all stages of handling raw beef product associated with the outbreak common source of the distinct strain of
products (67 FR 62328). and found it positive for E. coli E. coli O157:H7 associated with these
Although FSIS previously informed O157:H7. The Minnesota Departments individuals’ illnesses. The fact that both
establishments producing mechanically of Agriculture and Health Laboratories of the ill persons consumed an identical
tenderized raw beef products that they analyzed five samples of the product restaurant meal on the same day and
were required to reassess their HACCP associated with the outbreak and found had the onset of symptoms on the same
plans based on the availability of them positive for E. coli O157:H7. The date indicated that consumption of the
specific scientific data related to the product samples analyzed matched the tenderized beef steak product was
prevalence of E. coli O157:H7, only one two-enzyme PFGE pattern of the associated with the illnesses. As a result
outbreak (the 2000 outbreak discussed outbreak cases. The food histories of the of this investigation, the supplier of the
below) associated with such product persons who became ill, and the fact steaks agreed to procedural changes in
had occurred at the time these that the PFGE patterns in the product its operations, including sanitizing the
establishments conducted their HACCP samples analyzed matched the outbreak needle-piercing machine used and
plan reassessments. In addition, FSIS cases, provided strong evidence that testing its beef for E. coli O157:H7.
has not previously required consumption of the tenderized steak
establishments that produce cooked Reassessment in Response to Outbreaks
product was associated with the
mechanically tenderized beef products outbreak. The E. coli O157:H7 outbreaks
to reassess their HACCP plans to ensure At the time of the outbreak, the discussed above that were associated
that these HACCP plans adequately establishment that produced the with consumption of mechanically
address biological hazards, particularly tenderized beef steak product was tenderized beef products are events that
E. coli O157:H7. thoroughly breaking down, cleaning, could alter the hazard analysis, and
and sanitizing its injectors only once per ultimately the HACCP plan, of any
E. coli O157:H7 Outbreaks Associated establishment that produces
week. The establishment subsequently
With Mechanically Tenderized Beef mechanically tenderized beef products.
documented a revised plan in its
In August 2004, the Colorado Sanitation Standard Operating Therefore, as part of their next annual
Department of Public Health and Procedures (SOPs) to break down, clean, HACCP plan reassessment for such
Environment (CDPHE) confirmed by and sanitize its injection needles, products, establishments that produce
culture tests four E. coli O157:H7 cases tenderizing needles, and associated raw or cooked mechanically tenderized
with matching Pulse-Field Gel processing equipment on a daily basis. beef products (with or without
Electrophoresis (PFGE) patterns in the Also, after changing its Sanitation SOPs, marinade), hereafter referred to as
Denver, Colorado, metropolitan area. the establishment incorporated in its mechanically tenderized beef products,
The CDPHE determined that the production process an antimicrobial must take into account the E. coli
individuals who became ill in this treatment of the product prior to the O157:H7 outbreaks discussed above to
outbreak ate a tenderized, marinated tenderizing and marinating process. determine whether their HACCP plans
beef steak product at four separate The establishment that had produced for these products adequately address
locations of a national restaurant chain. the product linked to the 2003 outbreak biological hazards, particularly E. coli
The CDPHE conducted an age and sex- voluntarily recalled approximately O157:H7. Establishments that produce
matched case-control study that showed 739,000 pounds of product. Information mechanically tenderized beef products
that consumption of this particular steak on this recall can be found on the FSIS that have already taken these three
product was the only commonality of web page (http://www.fsis.usda.gov), outbreaks into account in a HACCP plan
those who became ill. Although the through the ‘‘FSIS Recalls’’ link, under reassessment for these products are not
CDPHE did not test product for E. coli recall case number 028–2003. required to consider these outbreaks in
O157:H7, the case-control study From information obtained from the their next annual HACCP plan
provided strong evidence that Centers for Disease Control and reassessment, provided the
consumption of this product was Prevention and State health establishments have evidence of their
associated with the outbreak. The departments, FSIS identified another reassessment in their hazard analysis or
producing establishment voluntarily outbreak that was associated with the HACCP plans, or a record of
recalled approximately 406,000 pounds consumption of mechanically reassessment, and make this evidence
of product. Information on this recall tenderized steaks. In August 2000, the available to FSIS inspection program
can be found on the FSIS web page Michigan Department of Community personnel.
(http://www.fsis.usda.gov), through the Health (MDCH) laboratory identified When conducting a reassessment that
‘‘FSIS Recalls’’ link, under recall case two human isolates of a distinct strain takes these outbreaks into account to
number 033–2004. of E. coli O157:H7 with matching PFGE determine whether HACCP plans for
In June 2003, State health patterns. This strain had not been mechanically tenderized beef products
departments confirmed by culture tests previously found in Michigan. adequately address biological hazards,
eleven E. coli O157:H7 cases in five Local health departments obtained E. coli O157:H7 in particular,
States: Seven cases in Minnesota, one case histories from both of the persons establishments may need to evaluate the
case in Michigan, one case in Kansas, who had become ill. The only similar adequacy of any E. coli O157:H7
one case in Iowa, and one case in North possible exposure to the pathogen for interventions applied to the products’
Dakota. The cases were a two-enzyme the two individuals was a steak meal source materials. If they have not
PFGE pattern match. Based on the food consumed by each on August 12, 2000, already done so, establishments
intake histories of the persons who at different locations of a local producing mechanically tenderized beef
became ill, the State health departments restaurant steakhouse chain. Each products may wish to consider
epidemiologically linked all cases to a individual had eaten a sirloin steak implementing purchase specifications
tenderized beef steak product (a cooked to order with a red or pink that require that incoming product has
boneless beef filet bacon-wrapped steak center. The sirloin steaks were needle been treated to eliminate or reduce E.
product injected with marinade). The tenderized. The investigation of this coli O157:H7 to an undetectable level. If
Michigan Department of Agriculture matter suggested that the sirloin steak establishments producing mechanically
Laboratory analyzed one sample of eaten by each person was likely the tenderized beef products require their

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Federal Register / Vol. 70, No. 101 / Thursday, May 26, 2005 / Rules and Regulations 30333

suppliers to meet such purchase products are cooked adequately to E. coli O157:H7 compared to intact beef
specifications, they should also ensure destroy E. coli O157:H7, should it be steaks, if prepared similarly to intact
that their suppliers actually meet these present. Such cooking instructions, or beef steaks. Based on information from
purchase specifications. Establishments other labeling, however, cannot serve as a Master’s thesis (Sporing, 1999),
could incorporate such purchase a control or critical control point (CCP) NACMCF concluded that non-intact,
specifications in their HACCP plans, in to address E. coli O157:H7 in the blade tenderized beef steaks do not
their Sanitation SOPs, which FSIS has production process of raw, present a greater risk to consumers from
recognized as prerequisites for HACCP, mechanically tenderized beef products. E. coli O157:H7 than intact beef steaks
or in other prerequisite programs. FSIS itself is considering requiring if the blade tenderized beef steak is oven
Establishments producing that raw, mechanically tenderized broiled and cooked to an internal
mechanically tenderized beef products products be labeled to indicate that they temperature of 140 degrees F or above.
might also consider applying an allowed have undergone mechanical However, NACMF concluded that blade
antimicrobial agent to the surface of the tenderization, that the product is non- tenderized beef steaks present a greater
product prior to processing or intact, and that it should be cooked to risk from E. coli O157:H7 than intact
tenderization. FSIS has made available an adequate internal temperature to beef steaks, particularly to immuno-
on its web site a document entitled, destroy any pathogens that may have compromised individuals, when served
‘‘Guidance on Ingredients and Sources been translocated from the surface of the very rare with cold spots (less than 120
of Radiation Used to Reduce product to the interior. Although the degrees F internal temperature).
Microorganisms on Carcasses, Ground Federal meat and poultry products FSIS also asked NACMCF whether
Beef, and Beef Trimmings.’’ This inspection regulations require that any non-intact, blade tenderized beef roasts
document provides guidance on the use marinade injected in a product be listed present a greater risk to consumers from
of antimicrobials on beef products. A as an ingredient on the product’s label, E. coli O157:H7 compared to intact beef
link to the document is found with the they do not require that product be roasts, if prepared similarly to intact
October 7, 2002, Federal Register notice labeled to indicate that it has been beef roasts. NACMCF concluded that
entitled, ‘‘E. coli O157:H7 mechanically tenderized, and it is not there were insufficient data to answer
Contamination of Beef Products,’’ on the possible to discern visually whether this question adequately.
‘‘Interim and Final Rules’’ page of FSIS’ product has been mechanically Finally, FSIS asked NACMCF whether
web site http://www.fsis.usda.gov/ tenderized. available evidence supports the need for
Regulations_&_Policies/ Finally, establishments producing
a labeling requirement to distinguish
2002_Interim_&_Final_Rules_Index/ cooked mechanically tenderized beef
between intact and non-intact products
index.asp. products may need to consider whether
in order to enhance public health
When conducting their reassessment, their cooking procedures are adequate to
establishments producing mechanically protection. Again, NACMCF concluded
destroy E. coli O157:H7, should it be
tenderized beef products should that there were insufficient data to make
present. Information on a study
consider the number of times a response to this question at the time
concerning the effects of cooking on E.
tenderizers pass through the product. In the committee met. The NACMCF report
coli O157:H7 in blade tenderized steaks
addition, they should evaluate the lists research needs at the end of the
is included in the following section of
adequacy of their sanitation procedures document.
this document.
for mechanical tenderizers, including This section also includes information Participants at the 2004 Conference of
needles, and for associated processing on published studies concerning Food Protection discussed the handling
equipment, including reservoirs and bacteria other than E. coli O157:H7 in of blade tenderized steaks at retail
piping associated with the tenderizing the interior of mechanically tenderized facilities and restaurants. Participants
and enhancing operations. Because beef. In addition, it provides discussed the fact that blade tenderized
tenderizers pass through the product, information on guidelines developed by products typically are not labeled to
they may introduce biological hazards, industry associations regarding indicate that the products have been
including E. coli O157:H7, into the pathogen control in mechanically tenderized. They considered data from
interior of the product. Therefore, tenderized and enhanced beef products. the Master’s thesis that NACMCF
sanitation procedures are particularly reviewed (Sporing, 1999). These data
important in the production of Research and Guidance on the showed that 3 to 4 percent of the surface
mechanically tenderized beef products. Production of Mechanically Tenderized bacterial load of blade tenderized beef
Thus, Sanitation SOPs, other Beef Products steaks is transferred to the interior of the
prerequisite programs, or HACCP plans FSIS asked the National Advisory product. According to the thesis, among
should address procedures that ensure Committee on Microbiological Criteria three methods of preparation—oven
that all mechanical tenderizers and for Foods (NACMCF) to answer several cooking, commercial grilling, and skillet
associated processing equipment are questions with regard to E. coli O157:H7 cooking—skillet cooking provided the
cleaned on a regular basis to minimize in mechanically tenderized beef. least effective and most variable
the potential for translocating E. coli NACMCF met on August 3, 2001, and reduction in E. coli O157:H7.
O157:H7 from the exterior surface of the January 23, 2002, to discuss these Participants in the 2004 Conference
product to the interior and to minimize questions. A report on NACMCF’s for Food Protection recommended that
the potential for cross contamination responses to FSIS’’ questions is the Food and Drug Administration
within and among lots of production. available on the Internet at http:// (FDA) and USDA work together to
Establishments producing raw, www.fsis.usda.gov/OPHS/NACMCF/ develop guidance for retail facilities and
mechanically tenderized beef products 2002/rep_blade1.htm. The report is restaurants on the safe cooking of blade
might also consider including cooking entitled, ‘‘Escherichia coli O157:H7 in tenderized steaks and other non-intact
instructions, in addition to required safe Blade-tenderized, Non-intact Beef’’ steaks. The participants recommended
handling instructions (e.g., cook to at (updated September 9, 2002). that this guidance be included in the
least 140 degrees F), on packages of raw, FSIS asked NACMCF whether non- Annex of the Food Code, and that FDA
mechanically tenderized beef products, intact, blade tenderized beef steaks and USDA submit this guidance at the
or other labeling, to ensure that these present a greater risk to consumers from 2006 Conference for Food Protection.

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30334 Federal Register / Vol. 70, No. 101 / Thursday, May 26, 2005 / Rules and Regulations

FDA and USDA intend to prepare this throughout tenderizing or enhancing subscription service consisting of
guidance. operations and during cleaning and industry, trade, and farm groups,
Several articles in peer-reviewed sanitizing operations. consumer interest groups, allied health
journals discuss studies on the professionals, scientific professionals,
penetration of bacteria other than E. coli FSIS Actions To Enforce and Facilitate
and other individuals who have
O157:H7 into the interior of Compliance with the Reassessment
Requirement requested to be included. The update
mechanically tenderized beef products. also is available on the FSIS web page.
For example, one study concerning The Agency intends to instruct its Through Listserv and the web page,
salmonellae inoculated in beef rounds inspection program personnel to FSIS is able to provide information to a
found that mechanical tenderization determine whether establishments have much broader, more diverse audience.
increased the level of salmonellae in considered the significance of the three In addition, FSIS offers an email
core samples by about 1 logarithm, that outbreaks discussed in this notice as subscription service which provides an
dripping inoculated rounds into a 50 part of an annual HACCP plan automatic and customized notification
parts per million (ppm) chlorine reassessment for mechanically when popular pages are updated,
solution did not prevent the occurrence tenderized beef products. FSIS will also including Federal Register publications
of salmonellae in core samples of instruct inspection program personnel and related documents. This service is
mechanically tenderized units, and that to ensure that all establishments available at http://www.fsis.usda.gov/
Salmonella survived in the core and on producing mechanically tenderized beef news_and_events/email_subscription/
the surface of some, but not all, products, including small and very and allows FSIS customers to sign up
inoculated rounds cooked to an internal small establishments that may not for subscription options in eight
temperature of 130 degrees F (‘‘The belong to a trade association, are aware categories. Options range from recalls to
Effect of Mechanical Tenderization on that the Agency has issued this notice. export information to regulations,
Beef Rounds Inoculated with Finally, FSIS intends to instruct its directives and notices. Customers can
Salmonellae,’’ Johnson, R.W.; Harris, inspection program personnel to collect add or delete subscriptions themselves
M.E., and Moran, A.B., Journal of Food data concerning the outcomes of the and have the option to password protect
Safety. 1978; 1(3): 201–209; 9 ref.). required reassessment. their account.
In another study, samples of
mechanically tenderized beef were Paperwork Reduction Act Done at Washington, DC on: May 20, 2005.
subjected to enumeration of aerobes, FSIS has reviewed the paperwork and Barbara J. Masters,
coliforms, E. coli, and organisms that recordkeeping requirements in this Acting Administrator.
formed black or grey on Harlequin TM notice in accordance with the [FR Doc. 05–10471 Filed 5–25–05; 8:45 am]
agar (a medium formulated for recovery Paperwork Reduction Act and has BILLING CODE 3410–DM–P
of Listeria). The study concluded that determined that the paperwork
cooking mechanically tenderized beef to requirements for the regulations that
a medium rare condition may be require establishments that produce DEPARTMENT OF THE TREASURY
adequate for ensuring the mechanically tenderized beef products
microbiological safety of this product, to reassess their HACCP Plans have Internal Revenue Service
provided it is devoid of excessive already been accounted for in the
contamination of deep tissues Pathogen Reduction/HACCP Systems 26 CFR Parts 1 and 602
(‘‘Microbiological Conditions for information collection approved by the
Mechanically Tenderized Beef Cuts Office of Management and Budget [TD 9207]
Prepared at Four Retail Stores,’’ Gill, (OMB). The OMB approval number for RIN 1545–AX93
C.O.; McGinnis, J.C., International the Pathogen Reduction/HACCP
Journal of Food Microbiology. 2004; Systems information collection is 0583– Assumption of Partner Liabilities
95(1): 95–102). 0103.
Another study found that cleaning AGENCY: Internal Revenue Service (IRS),
and sanitizing the tenderizer with an Additional Public Notification Treasury.
iodine-based sanitizer (25 ppm titratable Public awareness of all segments of ACTION: Final and temporary
iodine) decreased the bacterial levels of rulemaking and policy development is regulations; and removal of temporary
mechanically tenderized rounds important. Consequently, in an effort to regulations.
(‘‘Microbial Aspects of Mechanical ensure that the public and in particular
Tenderization of Beef,’’ Raccah, M.; minorities, women, and persons with SUMMARY: This document contains final
Henrickson, R.L., Journal of Food disabilities, are aware of this notice, regulations relating to the definition of
Protection. 1979. 42(12): 971–973; 20 FSIS will announce it on-line through liabilities under section 752 of the
ref.). the FSIS web page located at http:// Internal Revenue Code (Code). These
Several industry associations (the www.fsis.usda.gov/ regulations provide rules regarding a
American Meat Institute, the National regulations__&__policies/ partnership’s assumption of certain
Cattlemen’s Beef Association, the 2005__Notices__Index/index.asp. fixed and contingent obligations in
National Meat Association, and the FSIS also will make copies of this connection with the issuance of a
Southwest Meat Association) have Federal Register publication available partnership interest and provide
developed guidelines to address through the FSIS Constituent Update, conforming changes to certain
pathogen control in mechanically which is used to provide information regulations. These regulations also
tenderized beef products and enhanced regarding FSIS policies, procedures, provide rules under section 358(h) for
beef products. These guidelines are regulations, Federal Register notices, assumptions of liabilities by
currently available on the Internet, on FSIS public meetings, recalls, and other corporations from partners and
the Beef Industry Food Safety Council types of information that could affect or partnerships. Finally, this document
Web site at http://www.bifsco.org/ would be of interest to our constituents also contains temporary regulations
BestPractices.aspx. The guidelines and stakeholders. The update is relating to the assumption of certain
present recommended practices communicated via Listserv, a free e-mail liabilities under section 358(h). The text

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