[Federal Register: January 19, 1999 (Volume 64, Number 11)]

[Rules and Regulations]               

[Page 2803-2805]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr19ja99-3]



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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



[[Page 2805]]



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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