99-13223. Listeria Monocytogenes Contamination of Ready-to-Eat Products  

  • [Federal Register Volume 64, Number 101 (Wednesday, May 26, 1999)]
    [Rules and Regulations]
    [Pages 28351-28353]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 99-13223]
    
    
    -----------------------------------------------------------------------
    
    DEPARTMENT OF AGRICULTURE
    
    Food Safety and Inspection Service
    
    9 CFR Parts 416 and 417
    
    [Docket No. 99-025N]
    
    
    Listeria Monocytogenes Contamination of Ready-to-Eat Products
    
    AGENCY: Food Safety and Inspection Service, USDA.
    
    ACTION: Compliance with the HACCP system regulations and request for 
    comment.
    
    -----------------------------------------------------------------------
    
    SUMMARY: The Food Safety and Inspection Service (FSIS) is publishing 
    this document to inform manufacturers of ready-to-eat livestock and 
    poultry products of the Agency's views about the application of the 
    hazard analysis and critical control point (HACCP) system regulations 
    to contamination with Listeria monocytogenes.
        FSIS believes that the findings from testing a range of ready-to-
    eat products and information from investigations of outbreaks of 
    listeriosis constitute changes that could affect an establishment's 
    hazard analysis or alter the HACCP plan for affected products. 
    Therefore, establishments must reassess their HACCP plans for ready-to-
    eat livestock and poultry products. If reassessment results in a 
    determination that Listeria monocytogenes contamination is a food 
    safety hazard reasonably likely to occur in the establishment's 
    production process, then it is a type of microbiological contamination 
    that must be addressed in a HACCP plan.
        In this document, FSIS is setting out several factors that it 
    believes an establishment should consider when performing its 
    reassessment. Also, FSIS is making guidance material available that 
    establishments may find helpful. (See ADDRESSES). FSIS invites comments 
    on the factors addressed in this document and on its guidance material.
    
    DATES: Comments may be submitted by July 26, 1999.
    
    ADDRESSES: Submit one original and two copies of written comments to 
    FSIS Docket Clerk, Docket No. 99-025N, 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 document 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.
        Guidance material is available from the Inspection Systems 
    Development Division, FSIS, USDA, Room 202, Cotton Annex Building, 300 
    12th Street SW, Washington, DC 20250-3700, phone (202) 720-3219, Fax 
    (202) 690-0824. The material is also available on the FSIS Homepage: 
    http://www.fsis.usda.gov/index.htm
    
    FOR FURTHER INFORMATION CONTACT: Daniel L. Engeljohn, Ph.D., Director, 
    Regulations Development and Analysis Division, Food Safety and 
    Inspection Service, Washington, DC 20250-3700; (202) 720-5627.
    
    SUPPLEMENTARY INFORMATION:
    
    Regulatory Context
    
        The Food Safety and Inspection Service (FSIS) administers the 
    regulatory program under the Federal Meat Inspection Act (FMIA) (21 
    U.S.C. 601 et seq.) and the Poultry Products Inspection Act (PPIA) (21 
    U.S.C. 451 et seq.) to protect the health and welfare of consumers by 
    preventing the distribution of livestock and poultry products that are 
    unwholesome, adulterated, or misbranded. To further the goal of 
    reducing the risk of foodborne illness from livestock and poultry 
    products to the maximum extent possible, FSIS issued the Pathogen 
    Reduction-Hazard Analysis and Critical Control Point (HACCP) Systems 
    final rule on July 25, 1996 (61 FR 38806). These regulations require 
    federally inspected establishments to take preventive and corrective 
    measures at each stage of the food production process where food safety 
    hazards occur.
        Part 416, the regulations on Sanitation Standard Operating 
    Procedures (SOP's), requires establishments to develop, implement, and 
    maintain written SOP's for sanitation that describe daily procedures 
    that are sufficient to prevent direct contamination or adulteration of 
    products (Sec. 416.11 and 416.12(a)). Part 417, the regulations on 
    HACCP systems, requires a hazard analysis to determine the food safety 
    hazards reasonably likely to occur in the production process and 
    identify the preventive measures an establishment can apply to control 
    those hazards in the production of particular products (Sec. 417.2(a)). 
    Whenever a hazard analysis reveals one or more such hazards, the 
    regulations require the establishment to develop and implement a 
    written HACCP plan, for each product, that includes specified controls 
    for each hazard so identified (Sec. 417.2(b)(1) and (c)).
        When FSIS issued the Pathogen Reduction-HACCP Systems final rule, 
    it responded to questions about the link between Sanitation SOP's and 
    HACCP plans by noting the importance of Sanitation SOP's as tools for 
    meeting existing sanitation responsibilities and preventing direct 
    product contamination and adulteration and their appropriateness as 
    near-term procedures--that is, for implementation prior to HACCP 
    implementation and, in a sense, as a prerequisite to HACCP. In response 
    to concerns about redundancy, the Agency noted that a sanitation 
    procedure incorporated into a validated HACCP plan need not be 
    duplicated in the establishment's Sanitation SOP's. FSIS also 
    anticipated that some Sanitation SOP procedures, such as those 
    addressing pre-operational cleaning of facilities, equipment, and 
    utensils were likely to remain in an establishment's Sanitation SOP's. 
    (61 FR 38834.)
        The HACCP system regulations require an official establishment to 
    develop and implement a written HACCP plan whenever a hazard analysis 
    reveals one or more food safety hazards that are reasonably likely to 
    occur in the production process ((Sec. 417.2(a), (b)(1), and (c)). 
    Paragraph (a)(1) of Sec. 417.2 specifies the purpose of a hazard 
    analysis: ``to determine the food safety hazards reasonably likely to 
    occur in the production process and identify the preventive measures 
    the establishment can apply to control those hazards.'' Ten potential 
    hazard areas, including microbiological contamination, are listed to 
    guide establishments in this analysis (Sec. 417.2(a)(3)).
        Section 417.2(a)(1) also provides that a food safety hazard is 
    reasonably likely to occur if a prudent establishment would establish 
    controls 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.
        The likelihood that a potential food safety hazard will occur in 
    the production process for a particular
    
    [[Page 28352]]
    
    product at a given location, and the identification and adequacy of 
    preventive measures to control a likely hazard, must be determined by 
    each establishment. Obviously, conditions may well change over time. 
    For this reason, the HACCP system regulations require every 
    establishment to reassess HACCP plan adequacy at least annually and 
    whenever any changes occur that could affect the underlying hazard 
    analysis or alter the HACCP plan (Sec. 417.4(a)(3)). When reassessment 
    reveals that a plan no longer meets the requirements for the contents 
    of a HACCP plan, the establishment must modify the plan immediately 
    (Sec. 417.4(a)(3)).
    
    Listeria Monocytogenes
    
        Listeria monocytogenes is a type of pathogenic bacteria often found 
    in the intestines of healthy animals (including humans) and in the 
    environments in which food producing animals are raised and processed 
    (e.g., in soil, water, and vegetation and on the surfaces of equipment, 
    floors, and walls). Therefore, food may be contaminated with this 
    microorganism and, after cooking or other treatment to destroy the 
    pathogen, may be recontaminated.
        Listeria monocytogenes can cause listeriosis, a serious and 
    sometimes fatal illness, for which pregnant women, newborns, the 
    elderly, and people with weakened immune systems are at risk. The most 
    common manifestation of listeriosis is meningitis. It also can cause 
    miscarriages and stillbirths. Advances in molecular subtyping methods 
    have improved scientists' ability to associate Listeria monocytogenes 
    with particular products and to detect outbreaks of listeriosis.
        Since the late 1980's, FSIS and the Food and Drug Administration 
    (FDA) have worked with food manufacturers to improve procedures for 
    ensuring that ready-to-eat foods (i.e., products that may be consumed 
    without any further cooking or other preparation) are free of Listeria 
    monocytogenes. In addition, for the past decade, FSIS has conducted a 
    microbiological testing program in which the Agency samples ready-to-
    eat livestock and poultry products, including cooked and fermented 
    sausages, cooked corned beef, sliced ham and luncheon meats, beef 
    jerky, cooked uncured poultry, and salads and spreads, in federally 
    inspected establishments. (For the Agency's current testing program 
    instructions, see FSIS Directive 10,240.2, Microbial Sampling of Ready-
    to-Eat Products Produced by Establishments Operating Under a HACCP 
    System.) FSIS treats ready-to-eat products in which Listeria 
    monocytogenes is found as adulterated under the FMIA or the PPIA (21 
    U.S.C. 453(g) or 601(m)).
        Between 1989 and 1993, the rate of illness from Listeria 
    monocytogenes declined. Over the next several years, there did not 
    appear to be any further decline, however, and since last fall, there 
    has been an increase in the number of cases caused by a specific 
    subtype--a previously rare ``E'' pattern--of Listeria monocytogenes. 
    The Centers for Disease Control, U.S. Public Health Service, Department 
    of Health and Human Services (DHHS), have reported 101 illnesses, 15 
    adult deaths and 6 stillbirths or miscarriages associated with this 
    ``E'' pattern. Using methodological advances that provide more specific 
    information about pathogens isolated from foods and humans, public 
    health agencies have obtained information associating the ``E'' pattern 
    subtype of Listeria monocytogenes with livestock and poultry products.
        FSIS currently is evaluating a range of measures, both short- and 
    long-term, to improve public health protection against this pathogen. 
    In aid of this evaluation, FSIS held a public meeting on February 10, 
    1999, at which research, regulation, and education activities along 
    with industry and government procedures, were discussed.
    
    Controlling Listeria Monocytogenes Contamination
    
        FSIS is publishing this document to advise federally inspected 
    establishments of the Agency's current position on one aspect of the 
    public health strategy to deal with Listeria monocytogenes 
    contamination and to provide an opportunity to comment on that position 
    as FSIS continues to develop a comprehensive strategy. FSIS is 
    concerned because some establishments have not reassessed their HACCP 
    plans after recent outbreaks of listeriosis caused by contaminated 
    ready-to-eat livestock and poultry products, and after some 
    establishments have produced ready-to-eat products adulterated with 
    Listeria monocytogenes. If Listeria monocytogenes contamination is a 
    food safety hazard reasonably likely to occur in an establishment's 
    production process, then it must be addressed in a HACCP plan. It would 
    not be sufficient to claim that the hazard is adequately dealt with in 
    the establishment's Sanitation SOP. HACCP plan reassessment is 
    necessary to determine whether the plan appropriately addresses this 
    hazard.
        FSIS views investigations of recent outbreaks of listeriosis and 
    findings of Listeria monocytogenes contamination, along with other 
    information now available on the prevalence and persistence of this 
    foodborne pathogen, as sufficient evidence that some establishments' 
    present approach to the food safety hazard presented by ready-to-eat 
    livestock food and poultry products adulterated with Listeria 
    monocytogenes does not comply with part 417 requirements. Therefore, 
    FSIS believes that Sec. 417.4(a)(3) requires that establishments 
    reassess the HACCP plans that cover ready-to-eat livestock and poultry 
    products.
        Put another way, the Agency does not see how--given the current 
    record of contamination incidents and information now available on the 
    prevalence and persistence of the microorganism, its ability to survive 
    under adverse conditions, and the apparent susceptibility of some 
    products to contamination--an establishment that produces a ready-to-
    eat product (other than one that is thermally processed-commercially 
    sterile, in accordance with part 318, subpart G, or part 381, subpart 
    X, of the regulations) could have confidence that, in operation, the 
    HACCP plan for the product meets part 417 requirements.
        FSIS' conclusion addresses only the need for HACCP plan 
    reassessment. FSIS cannot predict the likelihood that an establishment 
    producing ready-to-eat products would be required under the regulations 
    to incorporate, or alter, controls to prevent Listeria monocytogenes 
    contamination in one or more HACCP plans as a result of plan 
    reassessment. FSIS does believe, however, that given current knowledge, 
    Listeria monocytogenes contamination should be considered to be 
    reasonably likely to occur in the production of ready-to-eat livestock 
    and poultry products, especially if an establishment has produced 
    products adulterated with Listeria monocytogenes, or if the 
    establishment is producing one or more ready-to-eat products that are 
    susceptible to Listeria monocytogenes contamination in an environment 
    that is not known to be free of this pathogen.
        FSIS urges establishments that produce ready-to-eat livestock and 
    poultry products to perform the reassessment of their HACCP plans 
    within 30 days of the publication of this document. FSIS will instruct 
    its inspection personnel to verify that reassessments were conducted. 
    If an establishment does not reassess its HACCP plan in accord with 
    this document, FSIS will evaluate the establishment's compliance with 
    Part 417.
    
    [[Page 28353]]
    
        Set out below are factors that FSIS believes are relevant in 
    determining whether Listeria monocytogenes contamination is a food 
    safety hazard reasonably likely to occur in the production process and 
    in identifying preventive measures that establishments can apply to 
    control the hazard. Reassessments of HACCP plans should take these 
    factors into account. FSIS is providing technical information and other 
    Agency guidance material. (See ADDRESSES to obtain copies.) The Agency 
    invites comments on this guidance material and the factors set out 
    below.
        (1) Pathogen Levels in Starting Materials FSIS believes that it is 
    crucial that each establishment know the characteristics of its 
    starting materials and, in particular, keep itself informed about 
    evidence of Listeria monocytogenes contamination of the raw materials 
    or source of raw materials that the establishments use.
        (2) Validation of Lethality Treatment FSIS believes industry 
    members must comply rigorously with the HACCP plan validation 
    requirements of Sec. 417.4(a)(1), especially in ensuring that the 
    establishment can successfully apply a scientifically appropriate 
    lethality treatment under its commercial operating conditions (see 61 
    FR 38826-38827). Until the establishment demonstrates that it achieves 
    the anticipated lethality effect under actual in-plant conditions, 
    effectiveness is theoretical, and the plan is not validated.
        (3) Exposure to Contamination After Lethality Treatment The 
    available evidence on the presence of Listeria monocytogenes in food 
    processing environments appears to indicate an increased potential for 
    the contamination of product after a food is processed to destroy 
    pathogenic microorganisms. Therefore, an establishment's reassessment 
    of its HACCP plans needs to address such potential contamination. 
    Establishments should account for finished product characteristics such 
    as water activity, pH, and the presence or absence of one or more 
    barriers that inhibit pathogen growth. The HACCP plan must incorporate 
    any hazards identified by the reassessment.
        (4) Evidence of Product Contamination FSIS believes that any 
    finding of Listeria monocytogenes in an establishment's ready-to-eat 
    product, whether in government or industry test results, is 
    substantial, and perhaps conclusive, evidence that Listeria 
    monocytogenes contamination is a food safety hazard that is reasonably 
    likely to occur in its production process for that product. Therefore, 
    in the event of such a finding, FSIS' position is as follows. If the 
    establishment's HACCP plan does not already provide for the control of 
    Listeria monocytogenes, and absent substantial, scientifically 
    supportable reasons, that HACCP plan must be modified to address the 
    Listeria monocytogenes hazard and incorporate appropriate controls. If 
    the establishment's HACCP plan does address and control for Listeria 
    monocytogenes, the establishment must take the appropriate corrective 
    actions in accord with the requirements of 9 CFR 417.3. FSIS inspection 
    personnel will verify that the establishment has taken the necessary 
    corrective actions.
    
        Done at Washington, DC, on May 19, 1999.
    Thomas J. Billy,
    Administrator.
    [FR Doc. 99-13223 Filed 5-25-99; 8:45 am]
    BILLING CODE 3410-DM-P
    
    
    

Document Information

Published:
05/26/1999
Department:
Food Safety and Inspection Service
Entry Type:
Rule
Action:
Compliance with the HACCP system regulations and request for comment.
Document Number:
99-13223
Dates:
Comments may be submitted by July 26, 1999.
Pages:
28351-28353 (3 pages)
Docket Numbers:
Docket No. 99-025N
PDF File:
99-13223.pdf
CFR: (2)
9 CFR 416
9 CFR 417