[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]
[DOCID:fr13ap01-18]
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DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
9 CFR Parts 301, 303, 317, 318, 319, 320, 325, 331, 381, 417, and
430
[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.
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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,
[[Page 19103]]
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
measures.
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
follows:
Tentative Agenda for the FSIS Public Meeting on the Proposed Rule, ``Performance Standards for the Production of
Processed Meat and Poultry Products''
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May 9, 2001.......................... Morning................ Lethality and stabilization performance
standards
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
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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
Internet.
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
products.
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
products.
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
proposal.
Done in Washington, DC on April 10, 2001.
Thomas J. Billy,
Administrator.
[FR Doc. 01-9196 Filed 4-12-01; 8:45 am]
BILLING CODE 3410-DM-P