[Federal Register Volume 64, Number 11 (Tuesday, January 19, 1999)]
[Rules and Regulations]
[Pages 2803-2805]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-1123]


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DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Chapter III

[Docket No. 97-068N]


Beef Products Contaminated With Escherichia Coli O157:H7

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Policy on beef products contaminated with E. coli O157:H7.

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SUMMARY: In 1994, the Food Safety and Inspection Service (FSIS) 
notified the public that raw ground beef products contaminated with the 
pathogen Escherichia coli O157:H7 are adulterated under the Federal 
Meat Inspection Act unless the ground beef is further processed to 
destroy this pathogen. FSIS is publishing this notice to provide the 
public with information about its policy regarding beef products 
contaminated with Escherichia coli O157:H7 and to afford the public an 
opportunity to submit comments and recommendations relevant to the 
Agency's policy, and any regulatory requirements that may be 
appropriate to prevent the distribution of beef products adulterated 
with this pathogen.

DATES: Comments must be received by March 22, 1999.

ADDRESSES: Submit one original and two copies of written comments to 
FSIS Docket Clerk, Docket No. 97-068N, U.S. Department of Agriculture, 
Food Safety and Inspection Service, Room 102, Cotton Annex, 300 12th 
Street, SW, Washington, DC 20250-3700. All comments submitted in 
response to this notice will be available for public inspection in the 
Docket Clerk's office between 8:30 a.m. and 4:30 p.m., Monday through 
Friday.

FOR FURTHER INFORMATION CONTACT: Patricia F. Stolfa, Assistant Deputy 
Administrator, Regulations and Inspection Methods, Food Safety and 
Inspection Service, Washington, DC 20250-3700; (202) 205-0699.

SUPPLEMENTARY INFORMATION:

Introduction

    The Food Safety and Inspection Service (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 of meat and meat food products that are 
unwholesome, adulterated, or misbranded. This notice explains the 
Agency's policy governing beef products that contain the pathogen 
Escherichia coli O157:H7 (E. coli O157:H7). Interested parties are 
encouraged to submit their views, relevant information, and suggestions 
regarding this policy or any regulatory requirements that the 
commenters believe may be appropriate to prevent the distribution of 
products contaminated with E. coli O157:H7.

Beef Products of Concern

    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 unless the ground beef is further processed to destroy this 
pathogen. Exposure to E. coli O157:H7 has been linked with serious, 
life-threatening human illnesses (hemorrhagic colitis and hemolytic 
uremic syndrome). Raw ground beef products present a significant public 
health risk because they are frequently consumed after preparation 
(e.g., cooking hamburger to a rare or medium rare state) that does not 
destroy E. coli O157:H7 organisms that have been introduced below the 
product's surface by chopping or grinding (e.g., ground beef, veal 
patties, and beef pattie mix).
    The public health risk presented by beef products contaminated with 
E. coli O157:H7 is not limited, however, to raw ground beef products. 
Given the low infectious dose of E. coli O157:H7 associated with 
foodborne disease outbreaks and the very severe consequences of an E. 
coli O157:H7 infection, the Agency believes that the status under the 
FMIA of beef products contaminated with E. coli O157:H7 must depend on 
whether there is adequate assurance that subsequent handling of the 
product will result in food that is not contaminated when consumed.
    In evaluating the public health risk presented by E. coli O157:H7-
contaminated beef products, FSIS has carefully considered the 
deliberations of the National Advisory Committee on Microbiological 
Criteria for Foods (NACMCF) and its Meat and Poultry Subcommittee. Last 
year, the Food and Drug Administration (FDA) requested recommendations, 
for use in the 1999 edition of its Food Code, on appropriate cooking 
temperatures for, among other foods, intact beef steaks for the control 
of vegetative enteric pathogens. In discussing intact product, the 
Committee stated that:

    Due to a low probability of pathogenic bacteria being present in 
or migrating from the external surface to the interior of beef 
muscle, cuts of intact muscle (steaks) should be safe if the 
external surfaces are exposed

[[Page 2804]]

to temperatures sufficient to effect a cooked color change. In 
addition, the cut (exposed) surfaces must receive additional heat to 
effect a complete sear across the cut surfaces. . . .

    The Committee's definition of ``Intact Beef Steak'' limited the 
applicability of this conclusion to ``[a] cut of whole muscle(s) that 
has not been injected, mechanically tenderized, or reconstructed.'' \1\ 
For purposes of FDA's current Food Code (1997, Subpart 1-
201.10(B)(41)), ``injected'' means:
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    \1\ The NACMCF-adopted minutes of the Subcommittee on Meat and 
Poultry are available for viewing in the FSIS docket room.

manipulating a MEAT so that infectious or toxigenic microorganisms 
may be introduced from its surface to its interior through 
tenderizing with deep penetration or injecting the MEAT such as with 
juices which may be referred to as ``injecting,'' ``pinning,'' or 
``stitch pumping.'' \2\
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    \2\ A copy of the 1997 FDA Food Code is available for viewing in 
the FSIS docket room. In addition, an electronic version of the Code 
is linked on line through the FSIS web page located at http://
www.fsis.usda.gov.

    FSIS believes that in evaluating beef products contaminated with E. 
coli O157:H7, intact cuts of muscle that are to be distributed for 
consumption as intact cuts should be distinguished from non-intact 
products, as well as from intact cuts of muscle that are to be further 
processed into non-intact product prior to distribution for 
consumption. Intact beef cuts of muscle include steaks, roasts, and 
other intact cuts (e.g., briskets, stew beef, and beef ``cubes for 
stew,'' \3\ as well as thin-sliced strips of beef for stir-frying) in 
which the meat interior remains protected from pathogens migrating 
below the exterior surface).
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    \3\ The phrase ``cubes for stew'' generally refers to meat hand-
cut into uniform squares.
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    Non-intact beef products include beef that has been injected with 
solutions, mechanically tenderized by needling, cubing,\4\ Frenching, 
or pounding devices, or reconstructed into formed entrees (e.g., beef 
that has been scored to incorporate a marinade, beef that has a 
solution of proteolytic enzymes applied to or injected into the cut of 
meat, or a formed and shaped product such as beef gyros). Pathogens may 
be introduced below the surface of these products as a result of the 
processes by which they are made. In addition, non-intact beef products 
include those beef products in which pathogens may be introduced below 
the surface by a comminution process such as chopping, grinding, 
flaking, or mincing (e.g., fresh veal sausage and fabricated beef 
steak).
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    \4\ The term ``cubing'' generally refers to the process of 
flattening and knitting together meat into cutlet size products by 
means of a machine.
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    Intact cuts of beef that are to be further processed into non-
intact cuts prior to distribution for consumption must be treated in 
the same manner as non-intact cuts of beef, since pathogens may be 
introduced below the surface of these products when they are further 
processed into non-intact products. Manufacturing trimmings (i.e., 
pieces of meat remaining after steaks, roasts, and other intact cuts 
are removed) are an example of this type of product. Although 
manufacturing trimmings may be intact, they are generally further 
processed into non-intact products.
    The Agency believes that with the exception of beef products that 
are intact cuts of muscle that are to be distributed for consumption as 
intact cuts, an E. coli O157:H7-contaminated beef product must not be 
distributed until it has been processed into a ready-to-eat product--
i.e., a food product that may be consumed safely without any further 
cooking or other preparation. Otherwise, such products (i.e., non-
intact products and intact cuts of muscle that are to be further 
processed into non-intact products prior to distribution for 
consumption) must be deemed adulterated. Intact steaks and roasts and 
other intact cuts of muscle with surface contamination are customarily 
cooked in a manner that ensures that these products are not 
contaminated with E. coli O157:H7 when consumed. Consequently, such 
intact products that are to be distributed for consumption as intact 
cuts are not deemed adulterated.

E. coli O157:H7 Sampling and Testing Program

    FSIS currently samples and tests various raw ground beef products 
(including veal products) for E. coli O157:H7.\5\ The program sampling 
is done at inspected establishments and retail stores. The Agency has 
limited the sampling and testing program to beef products because 
foodborne illness from E. coli O157:H7 has not been associated, to 
date, with other types of livestock or poultry subject to federal 
inspection.
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    \5\ For the Agency's current sampling and testing program 
instructions, see FSIS Directive 10,010.1, Microbiological Testing 
Program for Escherichia coli O157:H7 in Raw Ground Beef, February 1, 
1998. A copy of this document is available for viewing in the FSIS 
docket room.
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    The sampling and testing program does not cover intermediate 
products, such as beef derived from advanced meat/bone separation 
machinery and recovery systems, since these products are generally 
further processed to formulate products such as hamburger, but they are 
not themselves distributed to consumers. Additionally, the sampling and 
testing program does not cover multi-ingredient products that contain 
beef, as well as other livestock or poultry ingredients (e.g., sausage 
that contains both fresh beef and pork).
    If FSIS confirms the presence of E. coli O157:H7 in a raw ground 
beef product sampled in the sampling and testing program, it takes 
regulatory action (coordinating with State officials for products found 
at retail). The action taken by FSIS is based on the facts of the 
particular case (e.g., the quantity of product that the sample 
represents; whether the product is associated with an outbreak of 
foodborne illness), but in all cases it reflects the Agency's 
determination that, unless further processed in a manner that destroys 
this pathogen (e.g., into ready-to-eat beef patties), the product 
involved that is contaminated with E. coli O157:H7 is adulterated.
    At this time, FSIS is not expanding its sampling and testing 
program to include all types of non-intact beef products or intact cuts 
of muscle that are to be further processed into non-intact products 
prior to distribution. The Agency may reconsider its sampling and 
testing program, as well as the scope of products deemed adulterated, 
in response to any comments received on the Agency's position regarding 
application of the FMIA's adulteration standards.

Other FSIS Activities

    FSIS's effort to reduce the risk of foodborne illness associated 
with beef products has included development of a guidance document to 
assist processors of ground beef in developing procedures to minimize 
the risk of E. coli O157:H7, and other pathogens, in their products. 
Draft Agency guidance, along with materials developed by two trade 
associations, was made available to the public and was the subject of 
an April 22, 1998, public meeting (63 FR 13618, March 20, 1998).\6\ The 
Agency has reviewed the comments received on the draft materials and is 
publishing a notice of the availability of the revised guidance in this 
issue of the Federal Register.
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    \6\ Copies of the comments received on the guidance document 
(Docket #98-004N), along with the transcript of the public meeting 
and the draft guidance document are available for viewing in the 
FSIS docket room. In addition, an electronic version of the FSIS and 
industry guidance documents are available on line through the FSIS 
web page located at http://www.fsis.usda.gov (see the link for HACCP 
guidance documents).
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    FSIS is participating in a risk assessment regarding E. coli 
O157:H7. A public meeting regarding the risk assessment was announced 
in an earlier

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Federal Register notice and was held on October 28, 1998 (63 FR 4432, 
August 18, 1998).\7\
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    \7\ Copies of the comments received on the risk assessment 
process (Docket #98-037N), the transcript of the risk assessment 
public meeting, and a preliminary scoping document are available for 
viewing in the FSIS docket room. In addition, an electronic version 
of the preliminary scoping document is available on line through the 
FSIS web page located at http://www.fsis.usda.gov (see the link for 
the Office of Public Health and Science, E. coli risk).
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    FSIS is now reviewing its regulations to determine what changes the 
Agency should make to increase consumer protection against meat and 
poultry products adulterated with E. coli O157:H7, or other pathogens. 
Therefore, FSIS is soliciting input from the public about regulatory 
requirements that may be appropriate to prevent the distribution of 
products adulterated with E. coli O157:H7. Any changes that the Agency 
would make in the regulations would have to be consistent with the 
Agency's view expressed in this notice that beef products, other than 
surface-contaminated intact cuts that are to be distributed for 
consumption as intact products, that contain E. coli O157:H7 are 
adulterated unless conditions of transportation and other handling 
ensure that they will not be distributed until they have been processed 
into ready-to-eat products.
    Because FDA has amended its regulations to permit the use of 
ionizing radiation for refrigerated or frozen uncooked meat, meat 
byproducts, and certain meat food products to control foodborne 
pathogens (62 FR 64107, December 3, 1997), FSIS is preparing a proposed 
rule on procedural and labeling requirements for irradiated products. 
Interested persons will have the opportunity, in that rulemaking, to 
submit comments to the Agency on irradiation treatment of E. coli 
O157:H7-contaminated products as an option for effectively eliminating 
this one specific pathogen.

    Done at Washington, DC, on January 13, 1999.
Thomas J. Billy,
Administrator.
[FR Doc. 99-1123 Filed 1-15-99; 8:45 am]
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