[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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