[Federal Register: April 13, 2001 (Volume 66, Number 72)]
[Proposed Rules]               
[Page 19102-19104]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food Safety and Inspection Service

9 CFR Parts 301, 303, 317, 318, 319, 320, 325, 331, 381, 417, and 

[Docket No. 97-013N]

Performance Standards for the Production of Processed Meat and 
Poultry Products--Notice of Technical Conference and Public Meeting; 
Extension of Comment Period

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Notice of technical conference and public meeting.


SUMMARY: The Food Safety and Inspection Service (FSIS) will hold a 
technical conference on May 8, 2001, in Washington, DC. The purpose of 
the conference is to discuss scientific research and new technologies 
relevant to the recently proposed regulatory requirements for processed 
meat and poultry products, ``Performance Standards for the Production 
of Processed Meat and Poultry Products.'' FSIS is soliciting papers and 
presentations from government agencies, academia, consumer 
organizations, and other interested parties.
    Additionally, on May 9 and 10, 2001, FSIS will hold a public 
meeting in Washington, DC, to provide information and receive public 
comments specific to the proposed regulations. FSIS is extending for an 
additional 30 days the comment period for the proposed regulations, 
previously scheduled to close on May 29, 2001. Comments now must be 
received by June 28, 2001. FSIS is extending the comment period to 
provide ample opportunity for the public to comment on issues raised at 
the technical conference and public meeting.

DATES: FSIS will hold the technical conference on May 8, 2001, and the 
public meeting on May 9-10, 2001. Comments on the proposed regulations 
published on February 27, 2001, at 66 FR 12590, must be received on or 
before June 28, 2001.

ADDRESSES: Both the technical conference and the public meeting will be 
held at the Washington Plaza Hotel, 10 Thomas Circle, NW., (at 
Massachusetts Avenue and 14th Street), Washington, DC 20005.
    Papers and presentations for the technical conference should be to 
sent to: Matthew Michael, Regulation and Directive Development Staff, 
OPPDE, FSIS, USDA, Room 103 Cotton Annex,

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300 12th Street, SW., Washington, DC 20250; by fax to: (202) 690-0486; 
or by electronic mail to: matthew.michael@usda.gov. Because of time 
restrictions, FSIS may not be able to schedule time for all interested 
parties to give papers or make presentations. Regardless, FSIS will 
make available at the conference submitted papers and other 
presentation materials, if requested by the author.
    To register for the public meeting, contact Ms. Mary Harris by 
telephone at (202) 690-6497, FAX to (202) 690-6500, or E-mail to 
mary.harris@usda.gov. If a sign language interpreter or other special 
accommodation is necessary, contact Ms. Harris at the above numbers by 
May 1, 2001. If you are planning to present an oral comment at the 
public meeting, please submit a copy of the prepared comment to the 
FSIS Docket Clerk, Docket No. 97-013P, Room 102 Cotton Annex, 300 12th 
Street, SW, Washington, DC 20250-3700.
    Send all written comments on the proposed regulations to: FSIS 
Docket No. 97-013P, Department of Agriculture, Food Safety and 
Inspection Service, Room 102, 300 12th Street, SW., Washington, DC 
20250-3700. All comments received will be considered part of the public 
record and will be available for viewing in the Docket Room between 
8:30 a.m. and 4:30 p.m. Monday through Friday.

FOR FURTHER INFORMATION CONTACT: Daniel Engeljohn, Ph.D., Director, 
Regulations Development and Analysis Division, Office of Policy, 
Program Development, and Evaluation, Food Safety and Inspection 
Service, Room 112 Cotton Annex, 300 12th Street, SW., Washington, DC 
20250. Telephone number (202) 720-5627, fax number (202) 690-0486.

SUPPLEMENTARY INFORMATION: On February 27, 2001, FSIS published a 
proposed rule ``Performance Standards for the Production of Processed 
Meat and Poultry Products'' (66 FR 12590). In that document, the Agency 
proposed food safety performance standards applicable to all ready-to-
eat (RTE) and all partially heat-treated meat and poultry products, as 
well as environmental testing requirements intended to reduce the 
incidence of Listeria monocytogenes in RTE meat and poultry products. 
FSIS also proposed to convert to performance standards the existing 
regulatory requirements for thermally-processed, commercially sterile 
(most often canned) meat and poultry products and to rescind certain 
requirements requiring the elimination of trichina from products that 
contain pork.
    FSIS is holding a technical conference to facilitate the submission 
and discussion of scientific research and technological data relevant 
to these proposed regulations. In the proposal, FSIS identified 
additional needs for data that if addressed could strengthen the 
scientific foundation of any final action. It is extremely important 
that the regulations be based on sound science and common sense 
    Selection of papers and presentations, as well as the forthcoming 
conference agenda, will ensure adequate discussion of all of the 
identified topics. FSIS also will try to accommodate presentations of 
relevant data not specifically requested in the proposal or below. FSIS 
requests that submissions for the technical conference concern 
scientific research and technological developments relevant to the 
proposed regulations, rather than merely be comment on the proposed 
regulations themselves. After FSIS has selected papers for 
presentation, it will make the technical conference agenda available on 
the Internet. At the public meeting also announced in the document, 
FSIS will provide information and accept public comments specific to 
the proposed regulations.
    FSIS intends to divide the public meeting to receive comments on 
the proposed regulations into four three-hour sessions, organized as 

Tentative Agenda for the FSIS Public Meeting on the Proposed Rule, ``Performance Standards for the Production of
                                      Processed Meat and Poultry Products''

May 9, 2001..........................  Morning................  Lethality and stabilization performance
                                       Afternoon..............  Requirements for the control of L. monocytogenes
May 10, 2001.........................  Morning................  Revisions to the regulations governing the
                                                                 elimination of Trichina from pork products and
                                                                 governing commercially-sterile (canned)products
                                       Afternoon..............  Economic impact of the proposed regulations and
                                                                 cost/benefit data needs

    FSIS invites interested parties to make oral comments or 
presentations at the public meeting. Please register in advance with 
Ms. Mary Harris and submit a written copy of your comments to the FSIS 
Docket Room (See ADDRESSES above). FSIS may revise the above public 
meeting agenda, depending on interest expressed in the various proposed 
regulations. As with the final agenda for the Technical Conference, 
FSIS plans to publish the final agenda for the Public Meeting on the 
    Also, the National Advisory Committee on Microbiological Criteria 
for Foods (NACMCF) will meet on May 7, 2001. This meeting also is open 
to the public. FSIS invites Committee members to attend the technical 
conference and public meeting announced in this document.
    FSIS is extending the comment period on the proposed regulations to 
provide ample opportunity for the public to comment on issues raised at 
the technical conference and public meeting.

Specific Scientific Information and Data Needs To Be Discussed at 
the Technical Conference

Testing for Listeria spp.

    FSIS proposed to require that each establishment that produces RTE 
meat and poultry products conduct testing of food contact surfaces to 
verify that its Sanitation SOPs are eliminating Listeria spp. from food 
contact surfaces, unless it has developed a CCP within its HACCP plan 
for the control of L. monocytogenes. FSIS is confident that will result 
in sanitation improvements that will lead to reductions in the 
contamination of RTE meat and poultry products by L. monocytogenes. 
However, FSIS is not aware of any research that correlates specific 
amounts or types of testing with specific remedial actions or 
reductions in contamination and welcomes the submission of any data. 
FSIS also requests comment as to whether other types of environmental 
testing, regular product testing, or some combination may be more 
effective in detecting L. monocytogenes contamination problems.
    FSIS has proposed required frequencies of testing that ensure very 
minimal levels of regular testing based on establishment size. FSIS is 
aware of no research linking volume of production with the likelihood 
of product adulteration by L.

[[Page 19104]]

monocytogenes, but considers it reasonable that insanitary 
establishments producing higher volumes of RTE meat and poultry 
products would be more likely to adulterate more product and thus pose 
more risk to the public health. As a result, FSIS has proposed a 
progressive series of testing frequencies intended to protect consumers 
from adulterated product. These testing frequencies also should 
minimize the costs of testing accrued by small business.
    FSIS requests any data that could bear on adjustments to the 
proposed frequencies, suggest other testing frequencies, correlate 
contamination risk with volume of production, or indicate what types 
and frequencies of testing for L. monocytogenes are most effective in 
detecting insanitation and possible adulteration of RTE meat and 
poultry products. Also, FSIS requests data regarding the relationship 
between Listeria spp. and L. monocytogenes and how that relationship 
should affect any requirements. For example, does a food contact 
surface positive for Listeria spp. scientifically necessitate product 
testing and what would negative product test results mean?
    FSIS also requests data regarding the costs and benefits of the 
proposed testing provisions, as well as other testing protocols. FSIS 
seeks any data correlating testing, reductions in establishment 
contamination, and consequent reductions in listeriosis that could be 
used to improve the Agency's cost/benefit analysis.

Lethality Performance Standards

    FSIS is proposing lethality performance standards for the pathogen 
Salmonella derived from the Nationwide Microbiological Baseline Data 
Collection Program. Using the positive samples in the baseline data, 
FSIS derived hypothetical worst case raw products and then determined 
the levels of pathogen reduction (lethality performance standards) 
that, if met, would render these worst case raw products ready-to-eat 
and unadulterated with a specific margin of safety. FSIS also 
translated the results of the application of the lethality performance 
standards into probabilities of remaining pathogens in finished RTE 
product. Consequently, an establishment that demonstrates that its 
incoming raw product is consistently less contaminated than the worst 
case could apply a lower lethality than proposed, as long as it 
achieves the corresponding probability of remaining pathogens in 
finished RTE product.
    It is possible that better data are available for deriving 
hypothetical worst case products and corresponding performance 
standards. For the lethality requirements concerning Salmonella, FSIS 
is unaware of any human health risk assessments that could be used to 
correlate changes in the performance standards with changes in public 
health benefits. Higher or lower lethality performance standards may be 
necessary in all or specific processing contexts. FSIS specifically 
requests any data that would support requiring different lethality 
performance standards to achieve certain public health benefits.
    The lethality performance standards for Salmonella already apply to 
numerous RTE meat and poultry products and FSIS believes that many 
establishments that produce RTE products not now subject to the 
proposed standards already meet them. It is likely, however, that some 
establishments will have to alter their processing methods to meet the 
proposed standards, i.e., to achieve higher levels of lethality in 
their RTE products. Further, manufacturers of RTE meat patties now only 
are required to comply with time/temperature regulations that yield a 
lesser level of lethality than what FSIS is proposing for all RTE meat 
products. FSIS requests information on the costs meat patty 
manufacturers and other establishments may accrue if required to meet 
the proposed lethality performance standards for RTE meat and poultry 
    FSIS also requests scientific information relative to the proposed 
lethality performance standards for E. coli O157:H7 in fermented RTE 
products that contain beef, especially information that indicates a 
different worst case and lethality performance standard for this 
pathogen may be warranted.

Stabilization Performance Standards

    Also under the proposal, all RTE meat and poultry products, other 
than thermally processed, commercially sterile products, and all 
partially heat-treated products, must be processed so as to prevent 
multiplication of toxigenic microorganisms such as C. botulinum and to 
allow no more than 1-log10 multiplication of C. perfringens 
within the product. Stabilization is commonly achieved by rapidly 
cooling product after cooking. It also can be achieved by the addition 
of a curing agent. These regulatory stabilization standards already 
apply to numerous RTE and partially-heat treated meat and poultry 
    Researchers have suggested to FSIS that there may be some 
inevitable growth of C. botulinum during a 1-log10 relative 
growth of C. perfringens and, therefore, compliance with the proposed 
zero growth standard for C. botulinum could in fact effectively require 
establishments to meet a more restrictive standard than that for C. 
perfringens. FSIS requests comment and scientific data relative to 
whether the Agency should revise the existing and proposed 
stabilization performance standard for controlling these two pathogens, 
as well as data on corresponding public health benefits.

Other Topics

    As mentioned above, FSIS welcomes the submission of papers and 
presentations on scientific and technical topics relevant to the 
proposed regulations, but not specifically mentioned above or in the 

    Done in Washington, DC on April 10, 2001.
Thomas J. Billy,
[FR Doc. 01-9196 Filed 4-12-01; 8:45 am]