[Federal Register Volume 66, Number 13 (Friday, January 19, 2001)]
[Notices]
[Pages 5515-5517]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-1439]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 99N-1168]

DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

[Docket No. 00-048N]


Relative Risk to Public Health from Foodborne Listeria 
Monocytogenes Among Selected Categories of Ready-to-Eat Foods; Draft 
Risk Assessment Document and Risk Management Action Plan; Availability

AGENCY: Food and Drug Administration, HHS, and Food Safety and 
Inspection Service, USDA.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA), and the Food Safety 
and Inspection Service (FSIS) of the U.S. Department of Agriculture 
(USDA) are announcing the availability of two documents: A draft risk 
assessment on the relationship between foodborne Listeria monocytogenes 
and human health that considers 20 ready-to-eat food categories, and a 
risk management action plan based on the L. monocytogenes risk 
assessment. We are making these documents available, and we are seeking 
public comment of a technical nature on the draft risk assessment. The 
risk management action plan identifies immediate actions as well as 
short-term and long-term activities targeted to reduce L. monocytogenes 
associated illnesses. This plan is intended to respond to the 
President's directive to reduce L. monocytogenes associated illnesses 
by 50 percent by the year 2005. HHS and USDA invite comments on the 
risk management strategies reflected in the action plan. A public 
meeting to discuss the draft risk assessment and the risk management 
plan will be announced in a future issue of the Federal Register.

DATES: Comments on the draft risk assessment and the HHS/USDA risk 
management action plan must be submitted by March 20, 2001.

ADDRESSES: Printed copies of the draft risk assessment and the risk 
management action plan may be requested by faxing your name and mailing 
address with the names of the documents you are requesting by faxing 
your name and mailing address with the names of the documents you are 
requesting to the CFSAN Outreach and Information Center at 1-877-366-
3322. The documents may be reviewed at the

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FDA Dockets Management Branch (address above) between 9 a.m. and 4 
p.m., Monday through Friday, and at the FSIS Docket Clerk's Office 
between 8:30 a.m. and 4:30 p.m., Monday through Friday.
    Submit written comments to the Dockets Management Branch (HFA-305), 
Docket No. 99N-1168, Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852. Two copies of comments are to be 
submitted, except that individuals may submit one copy.
or
    Submit one original and two copies of written comments to FSIS 
Docket Clerk, Docket No. 00-048N, U.S. Department of Agriculture, Food 
Safety and Inspection Service, Room 102, Cotton Annex, 300 12th St. 
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 electronic access to these documents see section III of the 
SUPPLEMENTARY INFORMATION section of this document.

FOR FURTHER INFORMATION CONTACT:
    For information concerning the draft risk assessment document: 
Sherri B. Dennis, Risk Assessment Coordinator, Center for Food Safety 
and Applied Nutrition (HFS-032), Food and Drug Administration, 200 C 
St. SW., Washington, DC 20204, 202-260-3984, FAX 202-260-9653, or e-
mail: [email protected].
    For information concerning the risk management action plan: Kathy 
Gombas, Center for Food Safety and Applied Nutrition (HFS-615), Food 
and Drug Administration, 200 C St. SW., Washington, DC 20204; 202-205-
4231; FAX 202-260-0136, e-mail: [email protected] or Charles 
Edwards, Food Safety and Inspection Service, U.S. Department of 
Agriculture, rm. 405, Cotton Annex, 300 12th St. SW., Washington, DC 
20250-3700; 202-205-0675; FAX 202-205-0080.

SUPPLEMENTARY INFORMATION:

I. Draft Risk Assessment

A. Background

    The draft risk assessment was written by FDA's Center for Food 
Safety and Applied Nutrition (CFSAN) and USDA/FSIS, in consultation 
with the Centers for Disease Control and Prevention (CDC). These 
agencies began this comprehensive quantitative microbial risk 
assessment (QMRA) in 1999, and have held two public meetings to present 
the framework of the assessment, the assumptions, and the modeling 
procedures.
    In the Federal Register of May 7, 1999 (64 FR 24661), FDA, in 
collaboration with USDA/FSIS, announced plans to conduct a risk 
assessment to determine the extent of consumer exposure to foodborne L. 
monocytogenes. In the Federal Registers of May 7, 1999 (64 FR 24663), 
and August 13, 1999 (64 FR 44225), the agencies announced public 
meetings to discuss issues related to the risk models under 
development. You may refer to these notices for further background 
information.

B. The Listeria monocytogenes QMRA

    The goal of this QMRA is to provide FDA and USDA/FSIS with 
information that will assist the agencies with the review of current 
programs and the development of new programs relating to the regulation 
of L. monocytogenes contamination in foods to ensure that such programs 
protect the public health. QMRA is a structured and systematic process 
of collecting and evaluating data and information to establish the 
risks to human health from consumption of pathogenic microorganisms. 
The draft risk assessment evaluates the available data on food 
consumption, contamination of various foods within 20 ready-to-eat food 
product categories by L. monocytogenes, growth of the pathogen in such 
foods, and the infectious dose. The draft risk assessment follows the 
framework recommended by both the National Academy of Sciences and the 
Codex Alimentarius Commission. This structured framework involves the 
following steps:
    (1) Hazard identification. The collection and critical review of 
data and information on L. monocytogenes.
    (2) Exposure assessment. The determination of total exposure to L. 
monocytogenes from consumption of various foods using prevalence and 
food consumption data.
    (3) Hazard characterization/Dose-response. The assessment of the 
potential for L. monocytogenes to cause illness in human populations 
using epidemiological investigations and data from animal studies.
    (4) Risk characterization. The integration of the exposure and 
dose-response data into a complex model to estimate both the risk to 
the public health and the uncertainty associated with this estimate.
The risk assessment process also includes the identification of data 
gaps and the development of, and the reliance on, reasonable 
assumptions when data are unavailable.
    As part of a peer evaluation of the draft risk assessment, FDA and 
USDA/FSIS are seeking comments that can be used to improve:
    (1) The assumptions made,
    (2) the modeling technique,
    (3) the data used, and
    (4) the transparency of the draft risk assessment document.
    It is our intent to review and evaluate all public comments and 
make modifications to the assessment, as appropriate. As noted 
previously, the draft risk assessment is available electronically on 
websites listed in section III of the Supplementary Information section 
of this document and may be reviewed at the FDA's Dockets Management 
Branch and FSIS's Docket Clerk's Office (addresses above).

II. HHS/USDA Risk Management Action Plan

A. Background

    On May 5, 2000, the President directed the Secretary of HHS and the 
Secretary of Agriculture to identify aggressive steps to reduce 
significantly the risk of illness and death from L. monocytogenes in 
ready-to-eat foods. The President called for action to reduce the 
number of L. monocytogenes illnesses by 50 percent by the year 2005--5 
years ahead of the previously established Healthy People 2010 target.
    The President directed the Secretary of HHS to develop an action 
plan identifying additional steps necessary to reduce L. monocytogenes 
contamination. He specifically directed that the HHS plan include 
consideration of control measures for at-risk foods, publication of 
guidance for processors, retailers, and food service facilities, and 
consideration of enhanced labeling to provide additional safeguards for 
consumers. The President also directed the Secretary of Agriculture to 
report back on the actions that would reduce significantly the risk of 
illness and death from L. monocytogenes in ready-to-eat foods. The 
President in particular directed the Secretary of Agriculture to 
``complete proposed regulations that include any appropriate 
microbiological testing and other industry measures'' to prevent cross-
contamination in the processing environment; ensure that the processing 
of ready-to-eat products meets appropriate standards; and ensure that 
such products are safe throughout their shelf-life. Taken together, 
these actions are designed to reduce L. monocytogenes-related illnesses 
by 50 percent by 2005.

B. The L. Monocytogenes Action Plan

    The action plan outlines the actions HHS and USDA intend to 
undertake to

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reduce L. monocytogenes illnesses from ready-to-eat foods. The plan 
focuses on those food categories identified in the draft risk 
assessment as either warranting additional measures to reduce L. 
monocytogenes contamination or warranting collection of additional 
data. Within HHS, FDA and CDC have the primary responsibility for 
implementation of this action plan. Within USDA, FSIS has the primary 
responsibility for implementation of this plan, working in concert with 
other USDA agencies through the Office of Food Safety.
    The action plan contains the following eight action areas:
    (1) Enhance consumer and health care provider information and 
education efforts;
    (2) Develop and revise guidance for processors, retailers, and food 
service/institutional establishments that manufacture or prepare ready-
to-eat foods;
    (3) Develop and deliver training/technical assistance to the 
regulated industry and food safety regulatory employees;
    (4) Review and redirect enforcement and regulatory strategies 
including microbial product sampling;
    (5) Propose new regulations and revisions to existing regulations 
as needed;
    (6) Enhance disease surveillance and outbreak response;
    (7) Initiate projects with retail operations such as delicatessens 
and salad bars to pilot new L. monocytogenes control measures including 
employee practices; and
    (8) Coordinate research activities to refine the risk assessment, 
enhance preventive controls, and support regulatory, enforcement, and 
educational activities.
    As noted, the draft risk assessment will be available, along with 
other information, to assist HHS and USDA as they consider the specific 
means to implement the elements of the action plan.

III. Electronic Access

    The draft risk assessment document and the risk management plan are 
available electronically as follows:

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Draft Risk Assessment Document   www.cfsan.fda.gov
                                 www.fsis.usda.gov
                                 www.foodsafety.gov
                                 www.foodriskclearinghouse.umd.edu
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The Risk Management Action Plan  www.cfsan.fda.gov
                                 www.foodsafety.gov
                                 www.fsis.usda.gov
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    Dated: January 11, 2001.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation, 
Food and Drug Administration, HHS.
Thomas J. Billy,
Administrator, Food Safety Inspection Service, USDA.
[FR Doc. 01-1439 Filed 1-18-01; 8:45 am]
BILLING CODE 4160-01-F