99-11319. Risk Assessment of the Public Health Impact of Foodborne Listeria Monocytogenes; Request for Comments and for Scientific Data and Information  

  • [Federal Register Volume 64, Number 88 (Friday, May 7, 1999)]
    [Notices]
    [Pages 24661-24663]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 99-11319]
    
    
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    DEPARTMENT OF HEALTH AND HUMAN SERVICES
    
    Food and Drug Administration
    [Docket No. 99N-1076]
    
    
    Risk Assessment of the Public Health Impact of Foodborne Listeria 
    Monocytogenes; Request for Comments and for Scientific Data and 
    Information
    
    AGENCY: Food and Drug Administration, HHS.
    
    ACTION: Notice; request for comments and for scientific data and 
    information.
    
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    SUMMARY: The Food and Drug Administration (FDA), in consultation with 
    the U.S. Department of Agriculture's Food Safety and Inspection Service 
    (USDA/FSIS), is announcing plans to conduct a risk assessment (RA) to 
    determine the prevalence and extent of exposure of consumers to 
    foodborne Listeria monocytogenes and to assess the resulting public 
    health impact of such exposure. The agencies request comments on 
    certain aspects of their approach to the RA and request that scientific 
    data and information relevant to the conduct of the RA be submitted.
    
    DATES: Written comments and scientific data and information by July 6, 
    1999.
    
    ADDRESSES: Submit written comments and scientific data and information 
    to the Dockets Management Branch (HFA-305), Food and Drug 
    Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    
    FOR FURTHER INFORMATION CONTACT: Richard C. Whiting, Center for Food 
    Safety and Applied Nutrition (HFS-300), Food and Drug Administration, 
    rm. 3822, 200 C St. SW., Washington, DC 20204, 202-260-0511, FAX 202-
    260-9653, or e-mail rwhiting@bangate.fda.gov''.
    
     SUPPLEMENTARY INFORMATION:
    
    I. Background
    
        L. monocytogenes is a bacterium that occurs widely in both the 
    agricultural (soil, plants, and water) and food processing environment. 
    The bacterium is resistant to various environmental conditions such as 
    high salt or acidity (Ref. 1).  L. monocytogenes grows at low oxygen 
    conditions and refrigeration temperatures, and survives for long 
    periods of time in the environment, on foods, in processing plants, and 
    in household refrigerators. Although frequently present in raw foods of 
    both plant and animal origin, it also can be present in cooked foods 
    due to post-processing contamination.  L. monocytogenes has been 
    isolated in such foods as: Raw and pasteurized fluid milk, cheeses 
    (particularly soft-ripened varieties), ice cream, raw vegetables, 
    fermented raw meat sausages, raw and cooked poultry, raw meats (all 
    types), and raw and smoked fish (Refs. 1, 2, and 3). Even when L. 
    monocytogenes is initially present at a low level in a contaminated 
    food, the organism can multiply during storage, including storage at 
    refrigeration temperatures. A survey of a wide variety of foods from 
    the refrigerators of listeriosis patients in the United States found 11 
    percent of the samples contained L. monocytogenes (Ref. 4).
         It is well established that ingestion of L. monocytogenes can 
    cause serious human illness, listeriosis (Refs. 1, 2, 5, 6, and 7). In 
    1997, the Centers for Disease Control and Prevention (CDC) Foodborne 
    Diseases Active Surveillance Network (FoodNet) showed that of all 
    foodborne illnesses, the rate of hospitalization was highest for 
    persons infected with L. monocytogenes (88 percent). Similarly, of all 
    of the foodborne pathogens tracked by CDC, L. monocytogenes had the 
    highest case fatality rate in that 20 percent of persons infected died. 
    CDC also found that the incidence of listeriosis is 0.5 per 100,000 
    population, compared to a combined rate of 51.2 per 100,000 for all 9 
    of the foodborne illnesses surveyed (Ref. 8). Thus, although serious, 
    listeriosis is a relatively rare foodborne illness. Most cases of 
    listeriosis occur in pregnant women or individuals with a predisposing 
    disease (such as alcoholism, diabetes, or cirrhosis of the liver) or an 
    impaired immune system resulting from either a disease (such as AIDS) 
    or immunosuppressive treatment for a malignancy or an organ transplant. 
    (Refs. 1 and 6).
        Listeriosis has a long incubation time (up to 5 weeks) and a range 
    of symptoms. Infection of a pregnant woman may result in flu-like 
    symptoms with fever, muscular pain, or headache, or the listeriosis 
    infection may be asymptomatic. Importantly, however, when a pregnant 
    woman contracts listeriosis, the fetus or newborn infant is likely to 
    suffer severe consequences from the maternal infection, including: 
    Spontaneous abortion, fetal death, stillbirth, neonatal septicemia, or 
    meningitis. In nonpregnant adults, septicemia and meningitis are the 
    most common result of a listeriosis infection, although organ 
    infections and mild gastroenteritis can also occur.
         Although the consequences of listeriosis may be severe, an 
    estimated 2 to 6 percent of the healthy population harbors L. 
    monocytogenes in their intestinal tract without signs of illness (Refs. 
    1 and 6). Because the documented prevalence of L. monocytogenes in 
    people and in commonly eaten foods is much higher than the documented 
    incidence of listeriosis, some experts believe that the ingestion of 
    low levels of L. monocytogenes may not result in illness and thus, may 
    not constitute a general public health hazard (Refs. 9 and 10).
        Since 1990, CDC has documented a decrease in the incidence of 
    listeriosis. Although not certain, this decrease may be attributed to 
    government and industry programs directed at improved sanitation and 
    process control. Listeriosis is typically characterized by sporadic 
    cases. However, a recent multi-State listeriosis outbreak associated 
    with the consumption of processed meats, with at least 73 illnesses and 
    16 deaths, has reaffirmed concerns that more preventative efforts are 
    needed.
        Historically, FDA has had a policy of ``zero tolerance'' for L. 
    monocytogenes based on the absence of the microorganism in a 25-gram 
    sample of a given production lot. In other words, FDA's position has 
    been that the detection of any L. monocytogene in a 25-gram sample 
    renders the food adulterated within the meaning of the Federal Food, 
    Drug, and Cosmetic Act (21 U.S.C. 342(a)(1)). As recently as 1995, FDA 
    affirmed this policy, as reflected in the decision in United States v. 
    Union Cheese Co., 902 F. Supp. 778, 784, 786 (N.D. Ohio 1995). In that 
    litigation, FDA's expert witness testified that the L. monocytogenes 
    bacterium grows at refrigerator temperatures and that the level of L. 
    monocytogenes required to cause illness is unknown (902 F. Supp at 
    784). FSIS (which regulates meat and poultry) likewise has historically 
    had a zero tolerance policy for L. monocytogenes.
        Other countries, including certain major trading partners of the 
    United States, take a slightly different approach to L. monocytogenes 
    contamination. Relying upon their interpretation of the existing 
    scientific data, countries such as Canada and Denmark have a ``non-zero 
    tolerance'' for L. monocytogenes for some classes of foods (Refs. 10 
    and 11).
    
    [[Page 24662]]
    
     For example, in Canada, ready-to-eat foods that have not been 
    associated with an outbreak and do not allow any growth of L. 
    monocytogenes during a 10-day period of refrigerated storage may 
    contain up to 100 L. monocytogenes organisms per gram without being 
    considered unlawful (Ref. 12). Denmark has six classes of foods that 
    have to meet various criteria for L. monocytogenes. In raw, ready to 
    eat foods, for example, 2 of 5 samples can contain between 10 and 100 
    organisms per gram, and no sample can exceed 100 organisms per gram. 
    Although the course taken by other countries concerning L. 
    monocytogenes contamination is not determinative of the U.S. approach, 
    the policies of certain major trading partners provides further context 
    to any reexamination of current U.S. policy.
        Quantitative RA has recently been identified as a useful tool for 
    evaluating the public health impact of microbial contamination. USDA/
    FSIS and FDA recently completed a quantitative RA of Salmonella 
    Enteritidis in shell eggs and egg products (Ref. 13). This RA is being 
    used to review and evaluate Federal regulatory approaches to ensuring 
    the safety of these products.
        As noted, although the incidence of listeriosis is relatively low, 
    the consequences of such infection are quite serious. A quantitative RA 
    of the prevalence and extent of exposure of L. monocytogenes will 
    provide a structured approach to synthesize and evaluate the available 
    data and information. To the extent that U.S. policy regarding L. 
    monocytogenes contamination requires reexamination, such a RA can serve 
    as a foundation for such reconsideration.
    
    II. Objectives of the Risk Assessment
    
        As noted previously, FDA and USDA/FSIS are jointly planning to 
    conduct an assessment of the risk posed by L. monocytogenes to American 
    consumers. A RA is a systematic and comprehensive collection of 
    information and analysis of such information that promotes an 
    understanding of the interactions of various factors in a complex 
    situation and provides a basis for making decisions. The goal of this 
    RA is to provide FDA and FSIS with the information needed to review 
    current programs relating to the regulation of L. monocytogenes 
    contamination in foods to ensure that such programs provide maximum 
    public health protection.
    
    III. Risk Assessment Plan
    
        The RA will seek and analyze three types of information: 
    Information concerning the epidemiology of foodborne listeriosis, 
    information concerning the level of L. monocytogenes contamination of 
    foods and consumption levels of such foods (i.e., an exposure 
    assessment), and information regarding the human health consequences of 
    such exposure (i.e., a dose-response analysis).
        1. The RA will analyze epidemiological evidence concerning the 
    foods implicated both in documented outbreaks and in sporadic cases of 
    listeriosis, the numbers of L. monocytogenes consumed, the populations 
    which became ill, and the severity of their illnesses.
        2. The exposure assessment component of the RA will determine the 
    frequency of occurrence of L. monocytogenes in different classes of 
    foods, particularly the ready-to-eat foods that are intended for 
    consumption without additional heating. Ready-to-eat foods are 
    represented by numerous types of dairy, seafood, meat, and plant 
    products. The RA also will collect and analyze information on the 
    number of viable organisms associated with these foods at the time of 
    consumption. When data are collected at processing stages prior to 
    consumption, the RA will utilize models for growth, survival, or 
    thermal inactivation to estimate actual exposure of the consumer to L. 
    monocytogenes. The RA also will utilize food consumption databases to 
    assess the amount of these foods that are consumed. The RA will use the 
    information about the frequency of occurrence and numbers of L. 
    monocytogenes and food consumption to estimate the number of L. 
    monocytogenes cells consumed.
        3. The RA will include an evaluation of the dose-response 
    relationship, which will describe the health effects from consuming 
    specific numbers of L. monocytogenes organisms. The information that 
    will form the basis of the dose-response relationship element of the RA 
    may come from epidemiological, animal, or in vitro studies. FDA and 
    FSIS recognize that the frequency and severity of illness may be 
    affected by the food matrix, characteristics of specific strains of the 
    organism, and variability in human susceptibility.
        The RA will examine a number of issues, including: What foods 
    contribute most to the consumption of L. monocytogenes, what are the 
    numbers of organisms when a food is contaminated, how frequently are 
    foods heavily contaminated, are some strains of L. monocytogenes more 
    virulent that others, what is the extent of organism growth during 
    storage (including storage at refrigeration temperatures), and what is 
    the likelihood of illness to various subpopulations from consuming 
    different numbers of L. monocytogenes. All assumptions and 
    uncertainties in the RA will be identified and documented. The RA 
    process will also include an evaluation of the adequacy of current 
    scientific knowledge, data, and information. This will suggest where 
    future research could be directed to reduce any uncertainty in the risk 
    estimate that prevents a clear understanding of the causes and impact 
    of listeriosis.
    
    IV. Data and Information Requested
    
        FDA and FSIS request comments on the risk assessment approach 
    outlined previously and the submission of any information relevant to 
    this RA. The agencies specifically request scientifically valid data on 
    the quantitative levels of L. monocytogenes in foods and data relating 
    to rate of consumption of foods likely to contain high levels of L. 
    monocytogenes.
        FDA believes that the credibility and validity of the RA require 
    that the process for the conduct of the RA be transparent, and thus, 
    all the data and information evaluated in the context of the RA and 
    utilized in the RA must be publically available. Accordingly, any data 
    or information submitted in response to this notice should be in a form 
    that permits public disclosure. Submitters of data and information 
    should not mark any information as ``Confidential'' and should fully 
    expect that any data or information submitted will be made available to 
    the public. Questions regarding the public availability of data and 
    information submitted in response to this notice should be directed to 
    the contact person above.
        As noted, the purpose of this request for data is to gather 
    relevant information to facilitate a valid RA of L. monocytogenes with 
    the larger goal of providing a sound scientific basis for the agencies' 
    policies regarding the regulation of L. monocytogenes contamination in 
    food. Although FDA would seek to remove from the market any existing 
    food product known to be adulterated, FDA does not intend to utilize 
    the submitted data and information to support future enforcement 
    activity against the manufacturers submitting the data. Accordingly, it 
    is acceptable that data submitted in response to this notice be 
    ``blinded'' in the sense that the data need not identify the particular 
    manufacturer or processor that was the source of the samples underlying 
    the results.
    
    [[Page 24663]]
    
        The RA team plans to present a summary of available literature to 
    the National Advisory Committee on Microbiological Criteria for Foods 
    at a meeting scheduled for May 26 through 28, 1999, in Chicago, IL. A 
    copy of the literature summary will be available prior to that meeting 
    on the Internet at ``http://vm.cfsan.fda.gov''. Comments and data 
    submitted in response to this notice or at that meeting will be 
    incorporated into the RA process, and the completed RA will be 
    publically presented in September 1999.
        Two copies of comments and scientific data and information are to 
    be submitted, except that individuals may submit one copy. Comments and 
    scientific data and information should be addressed to the Dockets 
    Management Branch (address above) and identified with the docket number 
    found in brackets in the heading of this document. Received materials 
    may be seen in the Dockets Management Branch between 9 a.m. and 4 p.m., 
    Monday through Friday.
    
    V. References
    
        The following references have been placed on display in the Dockets 
    Management Branch (address above) and may be seen by interested persons 
    between 9 a.m. and 4 p.m., Monday through Friday.
        1. Ryser, E. T. and E. H. Marth, Listeria, listeriosis, and food 
    safety, Dekker, NY, 1991.
        2. Farber, J. M. and P. I. Peterkin, ``Listeria monocytogenes, a 
    Food-borne Pathogen,'' Microbiology Review, 55:476-511, 1991.
        3. FDA, Bad Bug Book (Foodborne Pathogenic Microorganisms and 
    Natural Toxins), 1999, Internet address: ``http://vm.cfsan.fda.gov/
    mow/intro.html''.
        4. Pinner, R. W., A. Schuchat, B. Swaminathan, P. S. Hayes, K. 
    A. Deaver, R. E. Weaver, B. D. Plikaytis, M. Reeves, C. V. Broome, 
    and J. D. Wenger, ``Role of Foods in Sporadic Listeriosis. 2. 
    Microbiologic and Epidemiologic Investigation,'' Journal of the 
    American Medical Association, 267:2046-2050, 1992.
        5. CAST, ``Foodborne Pathogens,'' Council for Agricultural 
    Science and Technology, Task Force Report 122, Ames, IA, 1994.
        6. Rocourt, J. and P. Cossart, ``Listeria monocytogenes,'' In 
    Food Microbiology, Fundamentals and Frontiers, edited by M. P. 
    Doyle, L. R. Beuchat, and T. J. Montville, ASM Press, Washington, 
    DC, 1997.
        7. Miller, A. L., J. L. Smith, and G. A. Somkuti, ``Foodborne 
    Listeriosis,'' Soc. Indust. Microbiol., Elsevier, NY, 1990.
        8. CDC, Morbidity and Mortality Weekly Report, ``Incidence and 
    Foodborne Illnesses-Foodnet,'' 47(37);782, 1997.
        9. Farber, J. M., W. H. Ross, and J. Harwig, `` Health Risk 
    Assessment of Listeria monocytogenes in Canada,'' International 
    Journal of Food Microbiology, 30:145-156, 1996.
        10. ICMSF, ``Choice of Sampling Plan and Criteria for Listeria 
    monocytogenes,'' International Journal of Food Microbiology, 22:83-
    96, 1994.
        11. IFST, Microbiological Criteria for Retail Foods, 
    Professional Food Microbiology Group, Inst. Food Science and 
    Technology, Lett. Appl. Microbiol, 20:331-332, 1995.
        12. Health Canada, Compliance Guide/Policy on Listeria 
    monocytogenes in Ready-to-Eat Foods, 1994.
        13. FSIS, Salmonella Enteritidis Risk Assessment, Shell Eggs and 
    Egg Products, USDA, FSIS, Washington, DC, 1998.
    
        Dated: April 29, 1999.
    William K. Hubbard,
    Acting Director Commissioner for Policy.
    [FR Doc. 99-11319 Filed 05-06-99; 8:45 am]
    BILLING CODE 4160-01-F
    
    
    

Document Information

Published:
05/07/1999
Department:
Food and Drug Administration
Entry Type:
Notice
Action:
Notice; request for comments and for scientific data and information.
Document Number:
99-11319
Dates:
Written comments and scientific data and information by July 6, 1999.
Pages:
24661-24663 (3 pages)
Docket Numbers:
Docket No. 99N-1076
PDF File:
99-11319.pdf