[Federal Register: January 19, 2001 (Volume 66, Number 13)]
[Notices]
[Page 5515-5517]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19ja01-45]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
[[Page 5516]]
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: sdennis@cfsan.fda.gov.
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: Kathy.Gombas@cfsan.fda.gov 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
[[Page 5517]]
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:
------------------------------------------------------------------------
------------------------------------------------------------------------
Draft Risk Assessment Document www.cfsan.fda.gov
www.fsis.usda.gov
www.foodsafety.gov
www.foodriskclearinghouse.umd.edu
------------------------------------------------------------------------
The Risk Management Action Plan www.cfsan.fda.gov
www.foodsafety.gov
www.fsis.usda.gov
------------------------------------------------------------------------
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