[Federal Register: December 2, 2004 (Volume 69, Number 231)]
[Rules and Regulations]               
[Page 70051-70053]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food Safety and Inspection Service

9 CFR Part 430

[Docket No. 04-032N]

Availability of the Food Safety and Inspection Service Report on 
Assessing the Effectiveness of the Listeria Monocytogenes Interim Final 

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Notice of availability and request for comments.


SUMMARY: The Food Safety and Inspection Service (FSIS) is announcing 
the availability of the report ``Assessing the Effectiveness of the 
Listeria monocytogenes Interim Final Rule.'' The report was written by 
the Agency's Listeria monocytogenes (L. monocytogenes) Assessment Team 
(Team) and presents the findings and recommendations of the Team which 
was responsible for assessing and measuring the effectiveness of the 
regulation to control L. monocytogenes in certain ready-to-eat (RTE) 
meat and poultry products. FSIS requests comments on the report. FSIS 
will consider the report and the comments on it, along with the 
comments that we receive on the interim final rule itself, in deriving 
a final rule on L. monocytogenes.

DATES: To receive full consideration, comments should be submitted by 
January 31, 2005.

ADDRESSES: FSIS invites interested persons to submit comments on the 
report ``Assessing the Effectiveness of the Listeria monocytogenes 
Interim Final Rule''. Comments may be submitted by any of the following 
     Mail, including floppy disks or CD-ROM's, and hand-or 
courier-delivered items: Send to Docket Clerk, U.S. Department of 
Agriculture, Food Safety and Inspection Service, 300 12th Street, SW., 
Room 102 Cotton Annex, Washington, DC 20250.
    All submissions received must include the Agency name and docket 
number 04-032N. All comments submitted in response to the report, as 
well as research and background information used by FSIS in developing 
this document, will be available for public inspection in the FSIS 
Docket Room at the address listed above between 8:30 a.m. and 4:30 
p.m., Monday through Friday. The comments also will be posted on the 
Agency's Web site at http://www.fsis.usda.gov/regulations/2004_Notices_Index/

FOR FURTHER INFORMATION CONTACT: Dr. Arshad Hussain, Director, Data 
Analysis and Statistical Support Staff, Food Safety and Inspection 
Service, U.S. Department of Agriculture, (202) 720-3219.



    FSIS published an interim final rule, ``Control of Listeria 
monocytogenes in Ready-to-Eat Meat and Poultry Products'', on June 6, 
2003 (68 FR 34208) that was effective on October 6, 2003. The comment 
period on the interim final rule is being extended until January 31, 
2005, by another document published elsewhere in this issue of the 
Federal Register. The interim final rule requires that official 
establishments that produce certain ready-to-eat (RTE) meat and poultry

[[Page 70052]]

products prevent product adulteration by the pathogenic environmental 
contaminant L. monocytogenes. In particular, under the interim final 
rule, establishments that produce RTE meat and poultry products that 
are exposed to the environment after lethality treatments and that 
support the growth of L. monocytogenes will be required to have, in 
their hazard analysis and critical control point (HACCP) plans or in 
their sanitation standard operating procedures or other prerequisite 
programs, controls that prevent product adulteration by L. 
monocytogenes. The establishments must share with FSIS data and 
information relevant to their controls for L. monocytogenes. The 
establishments also must furnish FSIS with information on the 
production volume of products affected by the regulations. The 
establishments may make claims on the labels of their RTE products 
regarding the processes that they use to eliminate or reduce L. 
monocytogenes or to suppress or limit its growth in the products.

Purpose of the L. Monocytogenes Interim Final Rule Assessment Team

    The L. monocytogenes Assessment Team (Team) was assembled to assess 
and measure the effectiveness of the L. monocytogenes interim final 
rule and to report on what the rule has accomplished, what could be 
done to improve it, and what criteria should be used for long-term 
    The Team's report, ``Assessing the Effectiveness of the Listeria 
monocytogenes Interim Final Rule'', presents the Team's major findings 
and recommendations. The Agency will use information from this report 
in deciding whether to modify the interim final rule. FSIS wants to 
ensure that the L. monocytogenes regulations that are in place at the 
end of this process are as well-designed as they can possibly be as a 
tool to protect the public health. The Agency also wants to know what 
it can do to enhance the impact of initiatives associated with the 
rule, such as consumer education, retail outreach, and public health 

The Structure of the L. Monocytogenes Interim Final Rule Assessment 

    Out of the main assessment Team, FSIS formed seven smaller teams 
called Project Assessment Teams (PAT) to review various aspects of the 
interim final rule and related issues. Three teams, the Public Health 
team, the Economic Impact team, and the Labeling and Consumer Education 
team focused on the impact of the interim final rule. Two teams 
(Sampling Verification and Training) focused on the Agency's on-going 
verification of the rule. The teams focused on how the Agency verifies 
that the requirements of the interim final rule are met, and on how it 
is preparing its inspection program personnel to verify that the 
requirements of the interim final rule are met. The Small Plant 
Guidance Team and the Retail Team focused on activities that support 
the effective implementation of the interim final rule, i.e., the teams 
focused on what FSIS can do to facilitate compliance.
    Each PAT prepared a report of its findings and recommendations. A 
summary of the findings of each of the seven PATs follows. Also, the 
PAT reports were presented to the National Advisory Committee on Meat 
and Poultry Inspection (NACMPI). NACMPI made recommendations that were 
considered and addressed by each PAT.

Summary of the Findings of Each of the PAT's Reports on ``Assessing the 
Effectiveness of the Listeria Monocytogenes Interim Final Rule''

Public Health Team

    The Public Health team focused on whether it is possible to assess 
the effects of the rule on public health. The team recognized that it 
is early to judge these effects. The team investigated whether the rule 
has affected the alternatives chosen by establishments to control L. 
monocytogenes in post-lethality exposed RTE products. To assess whether 
there have been changes, FSIS conducted a survey of 1,490 Inspectors-
in-Charge (IIC) who cover over 2,900 establishments that produce RTE 
meat and poultry products. FSIS found that more than 87% of the 
establishments have changed their operations to more effectively 
control L. monocytogenes. For example, about 59% have started to test 
for Listeria or Listeria-like organisms on direct food contact 
surfaces; 27% have started using an antimicrobial agent to inhibit the 
growth of this organism; and over 17% have started using post-lethality 
treatments in RTE products.

Economic Impact Team

    The Economic Impact team assessed the assumptions that the Agency 
made in preparing the economic assessment that was part of the interim 
final rule. It also gathered data on the costs and benefits of the rule 
as implemented. For example, the team considered whether the rule is 
disproportionately affecting small establishments. It found that 56% of 
the L. monocytogenes-related FSIS noncompliance records (NRs) have gone 
to very small plants, but that this is not a disproportionate share 
given that very small plants represent about 51% of the plants that 
produce RTE product. The team found that most of the establishments 
that received a NR had chosen the least protective alternative to 
control L. monocytogenes available to establishments.

Labeling and Consumer Education Team

    The Labeling and Consumer Education Team focused in part on 
incentive labeling. The interim final rule stated that establishments 
can declare any processing methodology that they use to address L. 
monocytogenes on their label. The team found that no establishments are 
using incentive labeling. The team recommended that FSIS use focus 
group research to help develop statements that would provide 
flexibility in conveying the fact that RTE product has undergone post-
lethality treatment to destroy Listeria.

Sampling Verification Team

    The Sampling Verification team assessed the L. monocytogenes 
sampling that the Agency performs and determined whether improvements 
in that sampling are needed. The team recommended that the Agency 
complete the development of a risk-based sampling regime, including an 
intensified sampling program in response to positive findings. The 
Agency's work on this risk-based sampling will begin shortly using the 
information that FSIS collects on the volume of RTE products produced 
by establishments.

Training Team

    The Training team was responsible for ensuring that the Agency's 
inspection program personnel are appropriately trained to enforce the 
interim final rule. The team recommended that FSIS' Food Safety 
Regulatory Essentials (FSRE) course be given to all FSIS Consumer 
Safety Inspectors (CSI), and that it be supplemented with compact disc 
(CD) training that focuses on the interim final rule. FSIS has trained 
more than half of its 1,700 CSIs on FSRE, and it continually updates 
the course. The FSRE course has already been updated to reflect the 
interim final rule. The team also recommended that the work of the CSIs 
be supplemented by training of the FSIS Enforcement, Investigations, 
and Analysis Officers (EIAO) on the performance of specialized 

Small Plant Guidance Team

    The Small Plant Guidance team found that the Agency needs to 
develop better ways of ensuring that FSIS Compliance

[[Page 70053]]

Guides reach small and very small establishments. The team also 
suggested that, to be useful to small and very small plants, the 
guidelines be simplified.

Retail Team

    Finally, the Retail team focused on possible means of controlling 
L. monocytogenes in RTE products at retail establishments. This team 
found that slicing and packaging deli meats at retail establishments 
represents a significant source of exposure of L. monocytogenes. The 
team suggested two possible strategies for dealing with this problem: 
(1) education and outreach, and (2) use of antimicrobial agents in 
products to be sliced and sold at retail establishments. The team also 
pointed to efforts already underway in the Agency to compare the risk 
of listeriosis from product sliced in plants with the risk from those 
sliced at retail establishments. The results of this assessment will be 
used by the Agency in developing its strategy for retail 

Availability of the Complete Team Report

    The report on ``Assessing the Effectiveness of the Listeria 
monocytogenes Interim Final Rule'', with each of the Project Assessment 
Team's individual reports, is available on the Agency Web site at 
    The complete report may also be viewed in the FSIS Docket Room, 300 
12th Street, SW., Room 102 Cotton Annex, Washington, DC, 20250 between 
8:30 a.m. to 4:30 p.m.

Additional Public Notification

    Public awareness of all segments of rulemaking and policy 
development is important. Consequently, in an effort to ensure that the 
public and in particular minorities, women, and persons with 
disabilities, are aware of this notice, FSIS will announce it on-line 
through the FSIS Web page located at http://www.fsis.usda.gov.

    FSIS also will make copies of this Federal Register publication 
available through the FSIS Constituent Update, which is used to provide 
information regarding FSIS policies, procedures, regulations, Federal 
Register notices, FSIS public meetings, recalls, and other types of 
information that could affect or would be of interest to our 
constituents and stakeholders. The update is communicated via Listserv, 
a free e-mail subscription service consisting of industry, trade, and 
farm groups, consumer interest groups, allied health professionals, 
scientific professionals, and other individuals who have requested to 
be included. The update also is available on the FSIS Web page. Through 
Listserv and the Web page, FSIS is able to provide information to a 
much broader, more diverse audience.

    Done in Washington, DC, on October 29, 2004.
Barbara J. Masters,
Acting Administrator.
[FR Doc. 04-26515 Filed 12-1-04; 8:45 am]