[Federal Register Volume 66, Number 39 (Tuesday, February 27, 2001)]
[Proposed Rules]
[Pages 12590-12636]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-4420]
[[Page 12589]]
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Part II
Department of Agriculture
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Food Safety and Inspection Service
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9 CFR Parts 301, 303, et al.
Performance Standards for the Production of Processed Meat and Poultry
Products; Proposed Rule
Federal Register / Vol. 66, No. 39 / Tuesday, February 27, 2001 /
Proposed Rules
[[Page 12590]]
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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. 97-013P]
RIN No. 0583-AC46
Performance Standards for the Production of Processed Meat and
Poultry Products
AGENCY: Food Safety and Inspection Service, Agriculture.
ACTION: Proposed rule.
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SUMMARY: The Food Safety and Inspection Service (FSIS) is proposing to
amend the Federal meat and poultry inspection regulations by
establishing food safety performance standards for all ready-to-eat
(RTE) and all partially heat-treated meat and poultry products. The
proposed performance standards set forth levels of pathogen reduction
and limits on pathogen growth that official meat and poultry
establishments must achieve in order to produce unadulterated products,
but allow the use of customized, plant-specific processing procedures.
The proposed RTE performance standards apply to all RTE meat and
poultry products, which can be categorized as follows: Dried products
(e.g., beef or poultry jerky); salt-cured products (e.g. country ham);
fermented products (e.g., salami and Lebanon bologna); cooked and
otherwise processed products (e.g., beef and chicken burritos, corned
beef, pastrami, poultry rolls, and turkey franks); and thermally-
processed, commercially sterile products (e.g., canned spaghetti with
meat balls and canned corned beef hash).
Although FSIS routinely samples and tests some RTE products for the
presence of pathogens prior to distribution, there are no specific
regulatory pathogen reduction requirements for most of these products.
The proposed performance standards will help ensure the safety of these
products; give establishments the incentive and flexibility to adopt
innovative, science-based food safety processing procedures and
controls; and provide objective, measurable standards that can be
verified by Agency oversight.
FSIS also is proposing environmental testing requirements intended
to reduce the incidence of Listeria monocytogenes in RTE meat and
poultry products. Specifically, FSIS is proposing to require
establishments that produce RTE meat and poultry products to test food
contact surfaces for Listeria spp. to verify that they are controlling
the presence of L. monocytogenes within their processing environments.
Establishments that have developed and implemented HACCP controls for
L. monocytogenes would be exempt from these testing requirements.
Finally, FSIS is proposing to eliminate its regulations that
require that both RTE and not-ready-to eat pork and products containing
pork be treated to destroy trichina (Trichinella spiralis). These
requirements are inconsistent with HACCP and some will be unnecessary
if FSIS makes final the proposed performance standards for RTE meat and
poultry products.
DATES: Comments must be received on or before May 29, 2001.
ADDRESSES: Submit one original and two copies of written comments to
FSIS Docket #97-013P, U.S. Department of Agriculture, Food Safety and
Inspection Service, Room 102, Cotton Annex, 300 12 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 FURTHER INFORMATION CONTACT: Daniel L. Engeljohn, Ph.D., Director,
Regulation Development and Analysis Division, Office of Policy, Program
Development, and Evaluation, Food Safety and Inspection Service, U.S.
Department of Agriculture (202) 720-5627.
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Background
II. RTE Meat and Poultry Products
III. Performance Standards and HACCP
IV. The Proposed Performance Standards
A. Lethality
Compliance with the Proposed Lethality Performance Standards
Derivation of the Proposed Lethality Performance Standards
Selection of the Reference Organisms
Dried Products
Salt-cured Products
Fermented Products
Cooked and otherwise Processed Whole or Comminuted Meat Products
Meat Patties
Cooked and otherwise Processed Whole or Comminuted Poultry
Products
B. Stabilization
V. Listeria monocytogenes
A. Proposed Requirements for Controlling L. monocytogenes
B. Shelf-life and Labeling
VI. Thermally Processed, Commercially Sterile Products
A. Lethality
B. Commercial Sterility
C. Training
VII. Elimination of Trichina Treatment Requirements
VIII. Other Proposed Revisions to the Regulations
IX. Scientific Information and Data Needs
X. Summary of the Proposed Rule
XI. Compliance with Executive Order 12866
XII. Compliance with the Regulatory Flexibility Act
XIII. Executive Order 12988
XIV. Risk Analysis
XV. Additional Public Notification
XVI. Paperwork Requirements
XVII. References
XVIII. Proposed Regulations
Appendix 1
I. Background
Under the Federal Meat Inspection Act (FMIA; 21 U.S.C. 601 et seq.)
and the Poultry Products Inspection Act (PPIA; 21 U.S.C. 451 et seq.),
FSIS issues regulations governing the production of meat and poultry
products prepared for distribution in commerce. The regulations, along
with FSIS inspection programs, are designed to ensure that meat and
poultry products are safe, wholesome, unadulterated, and properly
marked, labeled, and packaged. In this document, FSIS is proposing to
establish new pathogen reduction regulations for ready-to-eat (RTE) and
partially heat-treated meat and poultry products. This proposed action
is compelled by recent outbreaks of foodborne illness related to the
consumption of adulterated RTE meat and poultry products, as well as
the need to provide objective, measurable pathogen reduction standards
that can be met by official establishments and compliance with which
can be determined through Agency inspection.
II. RTE Meat and Poultry Products
RTE meat and poultry products are products that have been processed
so that they may be safely consumed without further preparation by the
consumer, i.e., without cooking or application of some other lethality
treatment to destroy pathogens. Although many of these products, such
as frozen pizzas or country hams, customarily are cooked or otherwise
reprocessed by the consumer, they would be safe to eat, if unpalatable,
without this further preparation.
RTE meat and poultry products can be either non-shelf-stable or
shelf-stable. Non-shelf-stable, RTE products must be refrigerated until
consumption to prevent the growth of both pathogenic and spoilage
organisms. Shelf-stable products remain ready-to-eat under ordinary
temperature and humidity conditions and, if the package integrity is
maintained during holding, shipping,
[[Page 12591]]
storage, display at retail, and in the home, throughout the
manufacturer's shelf-life determination. Throughout the shelf-life,
shelf-stable products are safe to eat when unrefrigerated (at
temperatures over 50 deg.F or 10 deg.C) without additional
preparation. Thermally processed, commercially sterile meat and poultry
products are packaged in hermetically sealed containers (usually cans)
and also remain shelf-stable under unrefrigerated conditions (over 50
deg.F or 10 deg.C).
For the purposes of this proposal, FSIS has divided ready-to-eat
meat and poultry products into five categories, based on the type of
processing they receive: dried products; salt-cured products; fermented
products; cooked or otherwise processed whole and comminuted products;
and thermally-processed, commercially sterile products. Many of these
products can be either shelf-stable or non-shelf-stable.
Examples of RTE Products
------------------------------------------------------------------------
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Dried Products......................... Basturma, Pastirma, Basturmi.
Beef Sticks.
Carne Seca.
Dried Beef.
Dry Duck Breast.
Meat/Poultry Jerky.
Salt-Cured Products.................... Cappicola.
Coppa.
Country Ham.
Dry Cured Duck.
Parma Ham.
Prosciutto, Prosciutti.
Fermented Products..................... Alessandri (Dry Sausage).
Apenino (Dry Sausage).
Arles or D'Arles (Dry Sausage).
Blockwurst (Semi-Dry Sausage).
Cacciatore/Cacciatora (Dry
Sausage).
Cervelat.
Cervelat, Soft.
Chorizo.
Lebanon Bologna.
Pepperoni.
Salami, Soft.
Salami: Genoa, Italian, German.
Summer Sausage.
Thuringer.
Thuringer, Soft.
Cooked or Otherwise Processed Whole or Meat
Comminuted Products.
Berliner (Cooked, Smoked
Sausage).
Bologna.
Bratwurst, Cooked.
Braunschweiger/Liver Sausage.
Breakfast Link Sausage or
Patties.
Brown and Serve Sausage.
Burritos.
Cheese Smokies.
Cheesefurter.
Cheesewurst/Cheddarwurst.
Chili.
Chorizo.
Cooked Beef.
Cooked Ham.
Cooked Pork in BBQ Sauce.
Cotto Salami.
Entrees/Dinners.
Fleischkaese (Cured, Cooked
Sausage).
Frankfurters.
Frozen Entrees/Dinners.
Gyros.
Meat Loaf.
Meat Salads.
Meat Soups, Frozen.
Nem-Chua (Cooked, Pickled Ham
with Shredded Pork Skin).
Pasta with Meat Sauce.
Pastrami.
Pickled Pigs Feet in Vinegar.
Pickled Sausages/Meat in
Vinegar.
Piroshki.
Pork Barbecue.
Pork Sausage Patties.
Ravioli.
Roast Beef.
Roast Pork.
Souse.
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Stews.
White Hots.
Wieners.
Poultry (Includes Products
Containing any Amount of
Poultry).
Chicken Burritos.
Chicken BBQ.
Chicken Bologna.
Chicken Breast.
Chicken Franks.
Cooked Poultry.
Cooked Poultry Rolls.
Corn Chowder with Chicken.
Entrees/Dinners.
Poultry Loaf.
Poultry Patties.
Poultry Rolls.
Poultry Salads.
Poultry Soups, Frozen.
Turkey BBQ.
Turkey Franks.
Thermally-Processed, Commercially Canned Spaghetti with Meat
Sterile Products. Balls.
Canned Corned Beef Hash.
Canned Ham.
Canned Chicken Salad.
Canned Soups with Meat or
Poultry.
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FSIS is proposing to require that the processing of each of these
types of products achieve specific levels of pathogen reduction, as
well as control over the growth of target pathogens so that they do not
exceed specific levels. These levels are the performance standards.
Establishments also would be required to maintain these levels of
pathogen reduction and pathogen growth in their products, under normal
handling conditions, until their products reach the consumer.
FSIS already has established pathogen reduction performance
standards specific to certain types of not-shelf-stable, RTE meat and
poultry products. On January 6, 1999, FSIS published a final rule in
the Federal Register (FSIS Docket No. 95-033F; 64 FR 732) that
established performance standards for RTE roast beef, corned beef, and
cooked beef, all ``fully-cooked'' RTE poultry products, and partially-
cooked meat patty and poultry products. Those standards are consistent
with and, in fact, incorporated into the more comprehensive group of
standards proposed in this document.
III. Performance Standards and HACCP
Under the regulations in 9 CFR 417, FSIS requires each official
meat and poultry establishment to develop and implement a Hazard
Analysis and Critical Control Point (HACCP) system, a science-based
process control system for food safety that promotes systematic
prevention of biological, chemical, and physical hazards.
Establishments are responsible for developing and implementing HACCP
plans that incorporate the controls necessary and appropriate to
produce safe meat and poultry products. HACCP is a flexible system that
enables establishments to tailor their control systems to the needs of
their particular plants and processes. Performance standards can be
usefully and seamlessly incorporated into HACCP systems.
When developing a HACCP plan, an establishment must conduct a
hazard analysis to identify and list the physical, biological, or
chemical food safety hazards reasonably likely to occur in the
production process for a particular product and the preventive measures
necessary to control those hazards. The establishment then must
identify the critical control points (CCPs) in each of its processes. A
CCP is a point, step, or procedure in a food process at which control
can be applied to ensure that the occurrence of a food safety hazard is
prevented, eliminated, or reduced to an acceptable level. Next, the
establishment must establish critical limits for the preventive
measures associated with each identified CCP. A critical limit is the
maximum or minimum value to which a hazard must be controlled at a CCP
to prevent, eliminate, or reduce to an acceptable level the occurrence
of the identified food safety hazard. Critical limits are most often
based on process parameters such as temperature, time, water activity,
pH, or humidity. Significantly, critical limits must be designed to
satisfy relevant FSIS regulations, including performance standards.
Therefore, performance standards are an integral part of the HACCP
systems in official meat and poultry establishments. HACCP provides the
framework for industry to set up science-based process controls.
Performance standards tell establishments what those controls need to
achieve for their HACCP plans to be effective and provide a necessary
measure of accountability for achieving acceptable food safety.
Performance standards and HACCP provide meat and poultry establishments
with the incentive and flexibility to adopt innovative, science-based
processing procedures and controls; ensure safety for consumers; and
provide objective, measurable standards, compliance with which can be
determined through Agency inspection.
IV. The Proposed Performance Standards
A. Lethality
For each category of RTE product, FSIS is proposing at least one
lethality performance standard. The term ``lethality'' refers to a
required reduction in the number of specific pathogenic organisms.
Further, FSIS is proposing lethality performance standards that reflect
the destruction of ``reference'' organisms, i.e., microorganisms whose
elimination or reduction most often indicates the elimination or
necessary reduction of other pathogens of concern.
In this proposed rule, for all RTE products except thermally-
processed, commercially sterile products, the lethality performance
standards are
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expressed as probabilities of remaining numbers of the reference
pathogen in 100 grams of finished product after a successful lethality
treatment is, or treatments are, applied to hypothetical ``worst case''
raw product. The lethality performance standards also are expressed as
the number of decimal reductions of the reference pathogen required to
achieve those probabilities in hypothetical worst case products. These
decimal reductions are expressed as ``x-log10'', meaning
that the expected relative reduction of the reference organism would be
a factor of 10\x\. FSIS has tentatively concluded that effecting these
specific reductions ensure even a worst case product would present no
health risk to consumers.
For all RTE meat and poultry products, other than thermally
processed, commercially sterile products, FSIS is proposing to require
that processing achieve one of the following probabilities that that no
more than small numbers of Salmonella would remain in any 100 gram
sample of a finished product made from worst case product:
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>0 surviving >1 surviving >2 surviving >3 surviving >4 surviving
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39.4 9.06 1.45 0.177 0.0174
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Although an establishment's processing would be required to achieve
these probabilities that there will be few, if any, remaining pathogens
in finished product, any detectable levels of viable Salmonella in RTE
product would render that product adulterated.
Alternatively, official establishments may employ processes
validated to achieve specific levels of reduction of Salmonella
organisms throughout their finished, RTE meat and poultry products:
6.5-log10 throughout finished, RTE meat products and 7-
log10 throughout finished, RTE products containing any
amount of poultry. The probabilities in Table 1 are derived from
statistical models of hypothetical worst case meat and poultry products
that have been successfully processed to achieve 6.5-log10
and 7-log10 reductions in Salmonella, respectively. A
hypothetical, worst case raw meat product would contain 6.2-
log10 of Salmonella per hundred grams; a hypothetical, worst
case raw poultry product would contain 6.7-log10 of
Salmonella per hundred grams. See the section entitled ``Derivation of
the Proposed Lethality Performance Standards'' for further discussion.
The Agency has selected Salmonella as the reference organism for
most RTE meat and poultry products because: (1) It is prevalent in raw
poultry, beef, and pork; (2) it causes a high incidence of foodborne
illness; and (3) foodborne illness associated with Salmonella is
severe. See the section entitled ``Selection of the Reference
Organisms'' for additional discussion of how FSIS determined the
lethality performance standards and the target pathogen for each type
of RTE meat and poultry product.
Because destruction of reference organisms may not always result in
the elimination or necessary reduction of other pathogens of concern,
FSIS also is proposing to clarify in the regulations that
establishments must also reduce other pathogens and their toxins or
toxic metabolites to the levels necessary to prevent product
adulteration. It is the responsibility of the establishment to ensure
that the final product is safe. If FSIS were to find certain viable
pathogens in a RTE product at levels considered dangerous, even in
product otherwise free of the reference pathogen, it would consider
that product to be adulterated.
FSIS is not proposing any specific lethality performance standards
in addition to those that target the reference pathogen, Salmonella,
except for fermented RTE products that contain beef. Within its hazard
analysis, each establishment will be responsible for determining which
other pathogens might survive processing and then implementing the
appropriate control measures. FSIS requests comment on whether it
should enumerate, in its regulations, lethality performance standards
for other pathogens and toxins that can pose hazards to specific
products or within specific processing contexts.
FSIS is proposing an additional lethality performance standard for
all fermented RTE products that include any amount of beef, except
thermally-processed, commercially sterile products. The Agency is
proposing to require that establishments that produce these products
implement processes that result in the following probabilities that, at
worst, only minute amounts of E. coli O157:H7 organisms would remain in
any 100 gram sample of a finished product made from worst case product:
Table 2.--Probability (%) of E. Coli O157:H7 Surviving in 100 Grams of
Finished Product Made From Worst Case Product
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>0 surviving >1 surviving
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22.2 2.67
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Although an establishment's processing would be required to achieve
these probabilities of remaining pathogens in finished product, any
detectable levels of viable E. coli O157:H7 in RTE product would render
that product adulterated.
FSIS also is proposing that, alternatively, establishments may
employ processes validated to achieve a 5.0-log10 reduction
of E. coli O157:H7 throughout fermented products containing beef. The
probabilities in Table 2 are derived from statistical models applied to
hypothetical worst case beef products that have been processed to
achieve a 5-log10 relative reduction in E. coli O157:H7. A
hypothetical, worst case raw product that contained any amount of beef
would contain 4.4-log10 of E. coli O157:H7 per hundred
grams. See the section entitled ``Derivation of the Proposed Lethality
Performance Standards'' for further discussion.
The Agency is proposing this lethality performance standard in
addition to the Salmonella standard for fermented products that contain
beef for several reasons. In 1994, there was an outbreak of foodborne
illness linked to E. coli O157:H7 in fermented beef sausages. Also,
these products may not be fully cooked before fermentation and
fermentation creates an acidic environment in which E. coli O157:H7 can
survive.
Also, the FSIS Office of Public Health and Science (OPHS) recently
sponsored a study entitled ``Risk Assessment of the Public Health
Impact of Escherichia coli O157:H7 in Ground Beef'' (Ref. 1, available
for viewing by the public in the FSIS Docket Room). The draft risk
assessment shows that levels of E. coli O157:H7 in cattle represents a
risk to consumers of ground beef and that unless there is a significant
intervention on the farm or during processing, the risk is likely to
remain. This draft risk assessment is discussed further under the
sections entitled ``Derivation of the
[[Page 12594]]
Proposed Lethality Performance Standards'' and ``Fermented Products.''
Cattle and sheep may carry E. coli O157:H7 in the intestinal tract
at the time of slaughter. However, among commercially-prepared meat
products, only those that contain beef have been implicated in a number
of foodborne illnesses associated with this pathogen. Therefore, in
regard to meat and poultry products, the Agency is proposing this
standard only for fermented products that contain beef.
FSIS is not proposing this performance standard for fermented
poultry products that do not contain beef. E. coli O157:H7 has been
found to colonize the ceca of chickens and has been isolated from
retail poultry in the United States (Ref. 2, available for viewing by
the public in the FSIS Docket Room). However, FSIS has never found the
pathogen in raw or ready-to-cook samples of poultry obtained from
processing establishments. FSIS requests comment as to whether it
should also apply this standard to RTE fermented poultry products that
do not contain beef, as well as to RTE fermented meat products that do
not contain beef.
FSIS is proposing performance standards for thermally-processed,
commercially sterile meat and poultry products that are similar to
these lethality standards but derived somewhat differently. See the
section ``Thermally-Processed Commercially Sterile Products'' for a
complete discussion.
Compliance With the Lethality Performance Standards
To meet the proposed lethality performance standards,
establishments would need to employ processes validated either to
achieve the proposed decimal reductions of pathogens throughout a
finished product or that result in one of the stated probabilities that
only small numbers of reference organisms would remain viable in a
worst case finished product. To develop criteria for evaluating the
effectiveness of processes that achieve one of the proposed
probabilities, it will be necessary for the processor to define, using
associated statistical criteria, the expected characteristics of the
treated product after processing, assuming certain product conditions
before processing. For example, an establishment would need to specify
that the probability of there being more than x surviving organisms in
the finished product is no more than p, given that the worst case pre-
processed product contained at least y organisms.
By codifying acceptable probabilities of remaining reference
organisms in finished product, FSIS would be allowing establishments to
employ processes that achieve varying levels of lethality, therefore
providing processing flexibility while ensuring product safety. By also
proposing specific lethality performance standards in the regulations,
FSIS provides clear performance standards to establishments that may
not have the resources to derive an alternative lethality or the
ability to demonstrate that their process achieves a specific
probability that no more than a certain number of reference organisms
might exist in the finished product.
As explained above, FSIS has tentatively determined that processes
that achieve the proposed lethality performance standards will process
hypothetical, worst case raw product into finished, RTE product that
poses no health risk to the consumer and is thus safe. In reaching this
tentative conclusion, the Agency made conservative assumptions
concerning the actual lethality achieved throughout the product. The
Agency acknowledges that it might be possible for producers to
demonstrate scientifically that these lethality assumptions or the
Agency's defined worst case would not be applicable for their
particular processing situation. An establishment could then design a
process with lethality values that are different from those provided in
this rule, but that would still yield a product that meets the final
conditions equivalent to those achieved by the specific levels of
pathogen reduction contained in the lethality performance standards.
An establishment developing an alternative lethality treatment or
treatments and assuming an initial product condition other than the
worst case would need to include in its HACCP plan scientific data and
statistical validation that would justify the assumed initial
conditions and verify that these would remain constant over time. For
example, an establishment may be able to demonstrate that the number of
Salmonella is not uniformly distributed throughout a particular type of
product. The establishment also might demonstrate that because of
husbandry and slaughter practices, the worst case product processed
within an establishment differs from the worst case scenarios developed
for this rule. Demonstrations of initial product conditions solely by
statistical means would likely be insufficient to ensure that processes
that employ alternative lethalities will result in product that meets
the performance standards.
Generally, an establishment will need to demonstrate in its HACCP
plan how its lethality treatment results in a finished product
equivalent to that provided by compliance with the probabilities set
out in this proposal. The establishment will need to demonstrate the
relationships between the lethality treatments and the specific
characteristics of a product, such as physical and chemical properties.
This demonstration could involve the use of heat transfer equations and
should account for all variables that would affect lethality (e.g.,
size of product, humidity, density, thermal conductivity, specific
heat, shape, product composition, and strain of organism).
Finally, establishments employing alternative lethalities will need
to demonstrate, within their HACCP plans, that they have validated
their processes as being effective in ensuring product safety. Section
417.4(a)(1) of the HACCP regulations sets forth the ``initial
validation'' requirements for establishments under HACCP:
Upon completion of the hazard analysis and development of the
HACCP plan, the establishment shall conduct activities designed to
determine that the HACCP plan is functioning as intended. During
this HACCP plan validation period, the establishment shall
repeatedly test the adequacy of the CCPs, critical limits,
monitoring and record keeping procedures, and corrective actions set
forth in the HACCP plan. Validation also encompasses reviews of the
records themselves, routinely generated by the HACCP system, in the
context of other validation activities.
FSIS explains the derivation of the proposed lethality performance
standards in the following section. A technical paper (Ref. 3,
available for viewing by the public in the FSIS Docket Room and on the
Internet.\1\) explaining the derivation of the lethality performance
standards also is available. Establishments are encouraged to use this
paper when developing alternative lethalities. In the paper, FSIS
explains the methodology used to calculate the probability of remaining
Salmonella organisms in treated product.
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\1\ http://www.fsis.usda.gov /OPPDE/rdad/FRPubs/95-
033F_tech%20paper.pdf
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Notably, with any final action, FSIS will provide compliance guides
that give explicit processing instructions and time/temperature
combinations proven to achieve the proposed decimal reductions of
pathogens. Small and other establishments that do not have the
technical resources to demonstrate that they are meeting the proposed
[[Page 12595]]
performance standards may use these compliance guides to develop their
HACCP systems. FSIS has published compliance guides for meeting the
lethality and stabilization performance standards already set forth in
its January 6, 1999, final rule, has posted these documents to the FSIS
web page (http://www.fsis.usda.gov), and has made the documents
available free of charge via the Constituent Update (see section XIV
Additional Public Notification) and the FSIS docket room. FSIS expects
to make additional draft guidance documents available after publication
of this proposed rule and as information becomes available in order to
provide establishments with guidance for safely manufacturing RTE meat
and poultry products. These draft guidance materials will be clearly
identified as guidance materials and not as regulatory requirements.
These guides would be applicable to the processing of many of the RTE
meat and poultry products governed by these proposed regulations. FSIS
plans to update these guides soon in accordance with ongoing
Agricultural Research Service studies. Where possible, FSIS will base
its compliance guides on existing industry practices and requests
comment and information regarding processing that has been shown to
meet the proposed performance standards.
Derivation of the Proposed Lethality Performance Standards
Salmonella
To derive the proposed lethality performance standards for
Salmonella, FSIS first determined the levels of Salmonella in a
hypothetical worst case raw product of a fixed weight. The hypothetical
``worst cases'' for Salmonella and E. coli O157:H7 were derived using
data from FSIS's Nationwide Microbiological Baseline Data Collection
Program surveys (Ref. 4, available for viewing by the public in the
FSIS Docket Room). The baseline surveys conducted by FSIS were designed
to provide estimates of the national prevalence and levels of selected
bacteria of public health concern. Salmonella was one of the pathogens
specifically addressed in all of the baseline surveys for the various
classes of products. The baseline surveys were conducted over a
specified period of time ranging from a half year to a full year. The
baseline surveys were used to establish the pathogen reduction
performance standards for Salmonella that were included as a component
of the Pathogen Reduction-HACCP final rule of July 25, 1996 (61 FR
38806). The performance standards for Salmonella that were established
as part of the Pathogen Reduction-HACCP final rule differ from the
proposed lethality performance standards for Salmonella included as
part of this proposed rulemaking.
The Salmonella performance standards for the Pathogen Reduction-
HACCP final rule are designed as follows: they are applicable to
establishments that produce raw products; FSIS collects and tests
samples from raw product; the results of the raw product samples are
reported to the establishment by FSIS after a specified number of
samples are collected over time; and a positive result for Salmonella
in raw product generally does not result in an adulteration
determination. In contrast to this design, the Salmonella lethality
performance standards of this proposed rule are designed as follows:
they are applicable to establishments that produce ready-to-eat
products (not raw product); the establishment may sample and test
samples of RTE product as part of its verification activity associated
with the production of RTE product and any testing by FSIS is conducted
as part of the Agency's verification activity; and a positive result
for Salmonella in RTE product does result in an adulteration
determination. The premise and use of the lethality performance
standards for Salmonella in this proposed rule are unchanged from those
previously contained in the recent final rule for RTE products (64 FR
732, January 6, 1999). Consequently, the baseline surveys were used in
the design of two separate performance standards: one performance
standard identifies the prevalence of Salmonella in raw product over a
specified period of time; the other performance standard (addressed as
part of this proposed rule) identifies the expected reduction in the
level of Salmonella in RTE product in a specified lot of product. Since
these two performance standards apply to different types of
establishments (i.e., the former applies to establishments producing
raw product; the latter applies to establishments producing RTE
product), they are not duplicative standards nor do they directly
relate to each other. The only commonality between these two
performance standards for Salmonella is that they are both derived from
the same baseline surveys. The level of E. coli O157:H7 in raw products
also was assessed in the same baseline studies as were used to
determine the level of Salmonella in raw products.
Using the national baseline survey information to establish the
levels of selected bacteria of public health concern (e.g.,
Salmonella), the Agency then determined levels of lethality that would
limit the probability of any remaining Salmonella or E. coli O157:H7 in
finished product produced from worst case raw product. FSIS made
conservative but reasonable assumptions concerning measurement error
and distributions of organisms throughout the product. These
assumptions are fully discussed in the technical paper (Ref. 3,
available in the FSIS Docket Room and at the FSIS web page http://www.fsis.usda.gov). However, the assumptions are generally based on the
following which are further discussed below: the number of organisms
recovered from frozen samples; the sensitivity of the detection
methodology; the confidence level of measurement variability; and the
serving size. Thus, worst case levels in product are not expected to
actually occur, provided products are handled appropriately before
lethality treatments. The derived worst case levels are hypothetical
constructs meant to represent upper limits of possibilities for raw
product produced under appropriate, normal manufacturing conditions.
These conditions include maintaining the raw product at or below
temperatures known to prevent growth of Salmonella and most other
pathogenic organisms (e.g., at or below 40 degrees Fahrenheit). In
addition, they include processing the raw product into RTE product
quickly before the raw product's surface temperature becomes elevated
for sufficient amounts of time to allow Salmonella and most other
pathogenic organisms to multiple exponentially. FSIS believes that
under these conditions, processes that satisfy the performance
standards established as a result of this rulemaking will be safe.
The Agency used the most probable number (MPN) method for measuring
levels of Salmonella in the FSIS surveys of meat and poultry products.
The MPN measurements were made on frozen samples. The calculations used
to determine the number of organisms for the worst case product take
into account non-recovery of organisms in frozen samples.
For Salmonella, the Agency assumed a 30 percent recovery of
organisms from frozen samples (Ref. 3, available for viewing by the
public in the FSIS Docket Room). The expected recovery is a function of
how quick and long the sample was frozen. Based on FSIS experience with
samples, the approximate detection limit for recovery of Salmonella is
0.5 cells per gram in 25-gram frozen samples. This means that there is
a high probability that a 25-
[[Page 12596]]
gram sample with 13 organisms would be found positive. For the purposes
of this regulation, the Agency assigned a 99% probability that a 25-
gram sample with 13 Salmonella cells would test positive. Even if one
organism were recovered, the sample result would be positive, so that
the probability of a positive sample result can be expressed as
1\13\, where is the theoretical probability of a
single injured or uninjured Salmonella organism not being recovered.
With this assumption, for frozen samples, is approximately
70%, that is, there is a 70% probability that a single organism would
not be recovered. Thus, there is a 30% recovery of Salmonella cells.
To account for measurement variability, the Agency calculated the
97.5 percent upper confidence limit associated with the measured MPN
value (Ref. 3, available for viewing by the public in the FSIS Docket
Room). FSIS did not use the average level of Salmonella reported for
the various classes of product. Rather, in order to determine the
highest estimate for the level of Salmonella in raw products, FSIS took
the raw data, not the calculated average, and computed a number at the
97.5 percent upper confidence level. Using this upper limit, the Agency
then computed the upper limit for 143 grams of raw product. The Agency
used 143 grams of raw product as the basis for its calculations because
after cooking, assuming a 70 percent yield, 143 grams would result in
approximately 100 grams (3.5 ounces) of cooked product.
The Agency used the high MPN value for ground chicken (the highest
MPN value measured for poultry products) from the FSIS national
baseline surveys \2\ to determine the proposed lethality for Salmonella
for all RTE products containing poultry, other than thermally
processed, commercially sterile products. For ground chicken, the upper
97.5 percent confidence limit for the highest measured MPN value of
2300 MPN per gram for Salmonella, assuming a 30 percent recovery, is
approximately 37,500 cells/gram, which, when multiplied by 143 grams
totals approximately 6.7-log10 cells. Therefore, the level
of Salmonella organisms in a hypothetical worst case raw product would
be greater than 6.5-log10 but just less than 7.0-
log10. Consequently, to provide a margin of safety and to
use either a whole or half integer lethality, FSIS is proposing to
require a reduction in viable Salmonella of 7.0-log10, which
is 0.3-log10 above the worst case level, throughout RTE
products that contain poultry, other than thermally processed,
commercially sterile products. The consequence of this choice is that,
for a hypothetical ``worst case'' product, the probability of surviving
Salmonella organisms is 39.4%, assuming that the distribution of the
number of survivors is binomial with number parameter equal to the
number of organisms in the worst case and the probability parameter
equal to 1/10\x\ where x is the required decrease in viability.
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\2\ While the numbers of samples in the FSIS national surveys
are rather large, the largest MPN value, as an estimate of large
densities of pathogenic organisms, from a statistical perspective,
may have substantial statistical variation. Thus, to reduce
differences in required lethality reductions caused by statistical
variation, data sets of different species were combined if warranted
by consideration of the prevalences and possibly the geometric means
of the levels of the organisms for these species. The high value of
combined data sets was used for determining the hypothetical worst
case for these species. The criteria used for combining data sets of
different species are easier stated as the converse of criteria for
when data sets would not be combined and thus the lethality
requirements for these species would be different. The criteria for
determining when lethality requirements for two species, A and B,
are different are: For a given type of product, the lethality
requirement for species A is larger than that of species B if (1)
the high MPN value for species A is larger than that of species B,
and (2) the prevalence for species A is larger than that of species
B, or the prevalences are approximately equal and the geometric mean
for species A is larger than that of species B. Otherwise, the
lethality requirements would be the same and the high value of the
combined data set would be used for both species A and B. For the
products and pathogen considered in this proposed regulation, the
criteria for combining data depend upon the prevalences and the high
values.
---------------------------------------------------------------------------
Alternatively, an establishment may use a processing procedure
validated to achieve the probabilities in Table 1 above that no more
than specific amounts of Salmonella would remain in any 100 gram sample
of a finished, hypothetical worst case product. As stated above, these
probabilities would result in hypothetical worst case poultry products
that had been successfully processed to achieve a 7-log10
reduction in Salmonella.
To determine the proposed lethality for RTE meat products that do
not contain poultry, other than thermally processed, commercially
sterile products, the Agency used the high MPN value for whole beef
(the highest MPN value measured for all meat products): 240 MPN/cm\2\.
To translate this value to a level per gram, FSIS assumed that, for a
worst case level, a cut of meat is 0.8 cm and that the specific density
of beef is approximately 1.1 grams/cm\3\ (slightly lower than average)
(Ref. 3, available for viewing by the public in the FSIS Docket Room).
These factors are for practical purposes equal to 1, so that the MPN/
cm\2\ values are assumed to estimate the level per gram of product.
Thus, for the worst case derivation, the starting value is 240 MPN/g.
The 97.5 percent upper confidence limit, assuming a 30 percent
recovery, is 4100 cells/g. Because samples for the whole product
surveys consisted of pooled tissue from 3 different carcass sections,
and the prevalence was low (less than 3 percent), the Agency assumed
that the high value used for determining the worst case product is 3
times that of the measured MPN value. Thus, the 97.5 percent upper
confidence limit is multiplied by 3 and then multiplied by 143 grams.
The resulting number of organisms for the worst case product is
approximately 6.2-log10. Therefore, to provide the same
margin of safety as provided for with poultry products, the proposed
required lethality is obtained by adding 0.3 log10 to the
worst case level of 6.2 log10. Thus, FSIS is proposing to
require either a relative reduction in viable Salmonella of 6.5-
log10 throughout finished, RTE meat products, or
alternatively, one of the probabilities listed above in Table 1. FSIS
has not specified the probability of worst case product actually
occurring since the worst case was a hypothetical construct based, in
part, on a high confidence level of the maximum observed level of
microorganisms in a statistically designed national baseline. In
addition, FSIS made additional assumptions that FSIS believes to be
conservative. All the assumptions regarding the derivation of the worst
case are contained in the technical paper (Ref. 3, available in the
FSIS Docket Room and at the FSIS web page, http://www.fsis.usda.gov).
FSIS requests comments regarding these assumptions.
E. coli O157:H7
After a 1994 outbreak of illnesses caused by E. coli O157:H7, FSIS
recommended that producers of fermented RTE products that contain any
amount of beef validate their processes to achieve a 5.0
log10 lethality of E. coli O157:H7 (see additional
discussion under Fermented Products). This recommended lethality was
based on a report submitted to FSIS (The Task Force on Technical Issues
Arising from the National Advisory Committee for Microbiological
Criteria for Foods (NACMCF)). The 5-log10 relative reduction
was derived by adding 1 log10 as a safety margin to an
assumed worst case of 4.0 log10 that was recommended by the
NACMCF. If this lethality were applied in a product containing 10\4\
cells per gram, then it would be expected that a single cell would
remain. However, the conclusion that a
[[Page 12597]]
single E. coli O157:H7 cell per 10 grams (or a possible 10 cells per
100 grams) remaining in the product adequately prevents foodborne
disease is in question. Some researchers now believe that low numbers
of E. coli O157:H7 cells ingested are sufficient to cause foodborne
disease (Ref. 5, available for viewing by the public in the FSIS Docket
Room).
Presented in chapter 5 of the OPHS risk assessment are results of a
derivation of the possible number of E. coli O157:H7 cells in combo
bins of 2000 pounds or approximately 10\5.96\ grams (Ref. 1, available
for viewing by the public in the FSIS Docket Room). The highest number
associated with a non-zero probability is 10\7\ cells for which an
upper bound probability of occurrence is 0.002% (1/50,000). As
discussed above in the derivation of the proposed lethality
requirements, the Agency considers the number of cells in 143 grams of
raw product, accounting for a possible 70% yield when the product is
processed. A bin with 10\7\ cells implies that the expected number of
cells in 143 grams of raw product would be about 3.2 log10
cells per 100 grams. The assumptions used in deriving this number
assume that the E. coli O157:H7 cells present are uniformly distributed
throughout the bin, so that the 3.2 log10 represent an
average or expected number of cells per 143 grams of product. It is
clearly possible that there would be in some 143-gram portion more than
3.2 log10 E. coli O157:H7 cells. Thus, a worst case level
should be larger than 3.2 log10 E. coli O157:H7 cells.
To derive worst case levels for E. coli O157:H7 for the purpose of
determining a performance standard, the Agency applied the algorithm,
described above for Salmonella, using information presented in OPHS
risk assessment. This risk assessment presented results of MPN analyses
from the Agency's microbiological baseline surveys of bovine carcasses
(Ref. 1, available for viewing by the public in the FSIS Docket Room).
In total, out of about 4,000 samples, 4 samples were found positive.
For each positive a matching sample was analyzed using the MPN
procedure. Of the 4 analyzes, 2 were found positive. The highest
reported MPN value was 0.93 cells/cm\2\, which, as described above, is
assumed to represent level per gram value, or 0.93 MPN/gram. A 97.5
percent upper confidence limit for this value is 3.7 cells/cm\2\. FSIS
did not use the average level of E. coli O157:H7 reported for the
various classes of product. Rather, in order to determine the highest
estimate for the level of E. coli O157:H7 in raw products, FSIS took
the raw data, not the calculated average, and computed a number at the
97.5 percent upper confidence level.
The samples used for determining E. coli O157:H7 levels in the FSIS
surveys were frozen. In the OPHS risk assessment, information
concerning the recovery rate is given. It is stated in the report that
nine 25-gram samples of ground beef were inoculated with 0.7 E. coli
O157:H7 organisms per gram, and that eight of these samples
subsequently were detected as positive. In determining the possible
recovery for E. coli O157:H7 cells in a sample that is subsequently
frozen, FSIS assumes that the actual number of cells in a specified 25-
gram sample is a random variable, n, following a Poisson distribution,
f(n, ) = e -/n!, with expected
value = 17.5. If is the probability of not
recovering a given single cell, then the probability of detecting the
presence of E. coli O157:H7 in a 25 gram sample, is, =
(1-\n\)f(n, ) = 1-e
-(1-). Thus, the
probability of recovering a given cell is 1- =
-ln(1-)/. From nine samples, eight were detected
positive, so that a 97.5% lower confidence bound for is
0.6635. Using this value for , the derived value for
1- is 0.062, representing the recovery. For the worst case
level, the 97.5 percent upper bound, 3.7 cells/cm\2\, is divided by
0.062 to derive 59.45 cells/cm\2\.
As described above for deriving the worst case levels for
Salmonella in beef, the measured levels are multiplied by 3, to account
for the fact that samples from the bovine FSIS baseline surveys
consisted of a composite from 3 sections of the carcass, and for a
worst case derivation, FSIS assumes that all the cells existed in one
of the three sections. Thus, for the worst case level, the 59.45 cells/
cm\2\ is multiplied by 3, and then multiplied by 143 grams to derive an
approximate 4.4 log10 cells for the worst case level.
The above derivation indicates that the ``worst case'' level of 4.4
log10 cells per 143 grams is greater than the highest
expected level of 3.2 log10 cells per 143 grams derived in
the OPHS risk assessment. Consequently FSIS will use the 4.4
log10 as the ``worst case'' level.
To provide the same margin of safety as provided for with
Salmonella in poultry and red meat products, the lethality is obtained
by adding 0.3 log10 to the worst case level of 4.4
log10. However, foodborne illness associated with E. coli
O157:H7 might be more severe than that associated with Salmonella, as
testified to by the severity of many reported cases in children and
senior citizens. Also, as stated above, some researchers believe that
low numbers of ingested E. coli O157:H7 cells are sufficient to cause
foodborne illness. Furthermore, there is only a small amount of data
from the Agency's microbiological baseline survey: four samples, of
which only two were positive. This number of samples does not provide a
high degree of confidence in the magnitude of the higher levels that
might exist. Consequently, FSIS is requiring that processors of
fermented products containing beef achieve a higher probability of no
surviving cells of E. coli O157:H7 in treated worst case products than
that required for Salmonella. Specifically, FSIS is proposing a 5-
log10 lethality, which can be obtained by adding 0.6
log10 to the ``worst case'' level (instead of 0.3
log10 added for Salmonella). The probability of no surviving
E. coli O157:H7 cells given a ``worst case'' level of cells is about
78% (instead of 61% for Salmonella).
FSIS also examined measured levels of E. coli O157:H7 found in
suspect lots of hamburger identified in foodborne disease outbreaks
(Refs. 6 and 7, available for viewing by the public in the FSIS Docket
Room). Direct count determinations were as follows: 50, 100, 5100, and
6200 colony forming units (CFU) per gram. Because of the possibility
that the high E. coli O157:H7 levels represent product that has been
abused and thus are not representative of product produced in an
establishment and used in RTE product, FSIS could not, with complete
justification, use these values for determining a required lethality.
However, these results do suggest that a lethality of at least 5-
log10 is needed to help ensure an E. coli O157:H7 free RTE
product.
The derivation for the proposed lethality of E. coli O157:H7, in
using only a slightly higher probability of no surviving cells compared
to that used for deriving the proposed lethalities for Salmonella,
assumes only a slightly greater public health concern for E. coli
O157:H7. However, foodborne illness associated with E. coli O157:H7
might be significantly more likely than that associated with
Salmonella. As mentioned above, some researchers now believe that low
numbers of E. coli O157:H7 cells ingested are sufficient to cause
foodborne disease. This belief also is reflected in the recent OPHS
draft risk assessment regarding E. coli O157:H7 in ground beef (Ref. 1,
available for viewing by the public in the FSIS Docket Room). The dose
response model used in this report allows the possibility of a 1%
probability of illness when a random selected consumer ingests a
[[Page 12598]]
single cell; and when, ingesting 10 cells, the probability of illness
could be as high as 10%.
Consequently, FSIS may need to require that processors of fermented
products containing beef achieve a higher probability of no surviving
cells of E. coli O157:H7 in treated worst case products. For example,
if the proposed lethality were 5.5 log10, the probability of
no surviving E. coli O157:H7 cells in the hypothetical worst case would
be 92.4% instead of 77.8%; if the proposed lethality were 6.0, then the
probability of no surviving E. coli O157:H7 cells would be 97.5%.
Since the number of sample results from which the worst case was
derived is small, there is not a high degree of confidence in the
magnitude of the higher levels of E. coli O157:H7 that might exist.
Further information may require FSIS to adjust the worst case level and
thus the required lethality, accordingly. It is important to note,
however, that a fermentation process offers an extra degree of safety
compared to a heat process, given the same lethality. Unlike ordinary
cooked RTE products, the physio-chemical environment within fermented
products is hostile to the survival of pathogens. Thus, within an
ordinary cooked RTE product, sublethally injured bacteria may be able
to resuscitate and then multiply when the temperature rises. Within
fermented sausages, most of which are shelf-stable, resuscitation is
not possible. FSIS specifically requests comment on the proposed
performance standard for the pathogen E. coli O157:H7 in fermented
products containing beef.
FSIS has not specified the probability of worst case product
actually occurring since the worst case was a hypothetical construct
based, in part, on a high confidence level of the maximum observed
level of microorganisms in a statistically designed national baseline.
In addition, FSIS made additional assumptions that FSIS believes to be
conservative. All the assumptions regarding the derivation of the worst
case are contained in the technical paper (Ref. 3, available in the
FSIS Docket Room and at the FSIS web page, http://www.fsis.usda.gov).
FSIS requests comments regarding these assumptions.
Selection of the Reference Organisms
An explanation of how the Agency established the proposed reference
organisms for each category of RTE product, other than thermally
processed, commercially sterile products, follows.
Dried Products
The pathogens associated with dried (but not fermented) RTE meat
and poultry products are Salmonella, Listeria monocytogenes,
Staphylococcus aureus, E. coli O157:H7 and Trichinella spiralis. T.
spiralis is only associated with pork and game products. There are a
limited number of studies on the reduction of pathogens during the
processing of dried meat and poultry products.
J. A. Harrison and M. A. Harrison surface-inoculated one-third of a
beef jerky strip (15 x 1.5 x 1.5 cm.) with 0.1 ml of a 10\8\ CFU/ml
cell suspension each of L. monocytogenes, Salmonella typhimurium, and
E. coli O157:H7 (Ref. 8, available for viewing by the public in the
FSIS Docket Room). Results show that higher log reductions of the three
pathogens were obtained when beef jerky was preheated to 160 deg.F and
when curing agents were added. In general, L. monocytogenes was more
resistant to the treatments. However, after 10 hours of drying at 140
deg.F, the populations decreased to undetectable levels, resulting in a
5.5 to 6.0 log reduction of the three pathogens. After storage at 25
deg.C for 8 weeks, none of the pathogens were detected. Subsequent
challenge studies on inoculated ground beef jerky, with or without
curing agents, heated or unheated, showed that Salmonella spp. was in
general more resistant than L. monocytogenes to the integrated process.
However, after 6 hours of drying at 140 deg.F, L. monocytogenes and
Salmonella had about the same population reduction in preheated samples
(Refs. 9 and 10, available for viewing by the public in the FSIS Docket
Room).
These studies show that the time and temperature of drying and
other variables, such as the use of beef strips or formed ground beef
jerky, the addition of curing agents, and preheating before drying,
will affect the reduction of pathogens. Lethality of pathogens in dried
products is achieved by dehydration to a water activity (aw)
level that inhibits their growth. Preheating or precooking and the
addition of curing agents facilitate and add to the lethality factor.
In 1995, a salmonellosis outbreak was associated with commercially
produced beef jerky linked to three Salmonella serotypes (Ref. 11,
available for viewing by the public in the FSIS Docket Room). The CDC
Morbidity and Mortality Weekly Report (MMWR) report stated that the New
Mexico Department of Health investigated five outbreaks of
salmonellosis associated with locally produced beef jerky from 1966 to
1988 and one outbreak of staphylococcal food poisoning associated with
beef jerky in 1982. Also according to the MMWR, four other states
reported foodborne disease outbreaks associated with the consumption of
locally produced or homemade jerky from beef, bear, or cougar meat. The
outbreaks were caused by T. spiralis and by nitrite poisoning.
The MMWR set out the recommendations of CDC for the prevention of
bacterial growth in jerky production. CDC recommended rapid drying at
high temperatures (i.e., initial drying temperature >155 deg.F (68.3
deg.C) for 4 hours, then >140 deg.F (60 deg.C) for an additional 4
hours), and decreased water activity (i.e., aw = 0.86).
E. coli O157:H7 was implicated in one case in homemade venison
jerky (Ref. 12, available for viewing by the public in the FSIS Docket
Room). L. monocytogenes has not been reported to be associated with any
foodborne illness attributable to the consumption of commercial jerky
products. So, based on the epidemiological data and research studies on
jerky, it does not appear that E. coli O157:H7 or Listeria represent
serious hazards in commercially produced jerky. Consequently, FSIS
chose Salmonella as the proposed reference organism for dried products.
If a process used to produce dried products achieves the proposed
reduction in the number of Salmonella organisms, the number of T.
spiralis, E. coli O157:H7, and S. aureus should also be reduced to safe
levels because these organisms are generally less heat resistant than
Salmonella. L. monocytogenes is a problem more often because of
inadequate sanitation than inadequate processing. Under HACCP and
Sanitation SOP requirements, establishments must ensure that their
processing controls hazards in addition to Salmonella, such as L.
monocytogenes, if they are reasonably likely to occur.
Salt-Cured Products
The microbiological stability (the lethality during processing) of
salt-cured meats, such as salt-cured hams, is dependent on their low
water activity, the presence of nitrite, and smoke applied between the
salting and drying processes (Ref. 13, available for viewing by the
public in the FSIS Docket Room). Lethality of pathogens in the salt-
cured products is attained by low temperature salting and drying. Both
of these processes reduce the water activity to levels that inhibit the
growth of pathogens. The addition of nitrates or nitrites and smoke
enhance the inhibitive effect of the process.
[[Page 12599]]
There were two salmonellosis outbreaks linked to salt-cured hams:
Serrano variety cured ham in Spain and prosciutto ham in Italy (Refs.
14 and 15, available for viewing by the public in the FSIS Docket
Room). Low levels of salt and relatively high water levels in some
parts of the Serrano variety cured ham were judged to be the most
probable cause of Salmonella growth and consequent illness. Aside from
Salmonella, other pathogens of concern in salt-cured products are S.
aureus, L. monocytogenes, and T. spiralis. The Agency is proposing to
select Salmonella as the reference organism because outbreaks in salt-
cured products have been associated with Salmonella. As with dried
products, if the process used to produce salt-cured products achieves
the proposed 6.5-log10 or 7.0-log10 reduction in
Salmonella organisms, the number of these other pathogens should also
be reduced to safe levels. In addition, establishments would have to
ensure that processing also controls hazards other than Salmonella,
including other pathogens, that are reasonably likely to occur.
Fermented Products
In late 1994, 23 cases of illness caused by the pathogen E. coli
O157:H7 were reported in Washington State and northern California (Ref.
16, available for viewing by the public in the FSIS Docket Room).
Epidemiological investigations by State and local health agencies
associated the outbreak with the consumption of dry cured salami
products. In October 1995, the Pennsylvania State Department of Health
linked 26 cases of salmonellosis to the consumption of contaminated
Lebanon bologna (Ref. 17, available for viewing by the public in the
FSIS Docket Room).
After the 1994 outbreak of illnesses caused by E. coli O157:H7,
FSIS met regularly with scientists from the Agricultural Research
Service, representatives of the meat and poultry industry and members
of the NACMCF to develop a policy for ensuring the safety of shelf-
stable, RTE fermented sausages. This group developed several processing
options that would ensure a 5-log10 relative reduction of E.
coli O157:H7 in fermented sausages. In addition, FSIS approved a
processing option developed by the Blue Ribbon Task Force on E. coli
O157:H7 of the National Cattleman's Beef Association.
As explained previously, the 5-log10 reduction of E.
coli O157:H7 in dry and semidry fermented sausages was originally based
on the notion of adding a 1-log10 safety margin over an
assumed worst case of 10\4\ CFU/gram in raw product. FSIS offered 4
options to either achieve the recommended 5-log10 relative
reduction of E. coli O157:H7 or control for its presence in finished
product: (1) Apply the cooking treatment in either 9 CFR 318.17 or
318.23, (2) apply a validated integrated heat treatment of equal
lethality, (3) test product using ICMSF lot acceptance criteria, or (4)
apply a validated 5-log10 relative reduction or process that
results in less than 1 E. coli O157:H7 per 100 gram of finished
product. The Blue Ribbon Task Force of the National Cattlemen's Beef
Association specifically addressed Option 2--a validated 5-
log10 inactivation treatment. The Task Force focused on the
processing parameters of heat and acid sensitivity of the organism. The
processes and the resultant level of reduction of E. coli O157:H7 were
summarized in a table and flow chart. In addition, the report
recommended a fifth option, combination of sampling of raw ingredients
and a 2-log10 lethality treatment, and described the remaining 3
options.
On August 21, 1995, FSIS wrote to establishments producing
fermented sausages and strongly encouraged that they implement one of
the validated processing options contained in the document to ensure
the processing used achieves at least a 5-log10 relative
reduction of E. coli O157:H7. While most establishments have
implemented one of the processing options, not all have.
As discussed previously, in support of rulemaking, OPHS has
sponsored a risk assessment of E. coli O157:H7 in ground beef (Ref. 1,
available for viewing by the public in the FSIS Docket Room). The draft
risk assessment presents data on the prevalence of E. coli O157:H7
among breeding herds and feedlots of cattle, and E. coli O157:H7 levels
on carcass samples. This information shows that levels of E. coli
O157:H7 in cattle represents a risk to consumers of ground beef, and
that, unless there is a significant intervention on the farm or during
processing, the risk is likely to remain.
In addition, because of the incidence of foodborne illness linked
to E. coli O157:H7 in fermented sausages and because these products
ordinarily are not fully cooked before being fermented (which creates a
situation that may allow the survival of E. coli O157:H7), the Agency
is proposing to include E. coli O157:H7, in addition to Salmonella, as
a reference organism for fermented RTE meat and poultry products that
contain beef.
Under this proposal, processing of fermented products that contain
beef would be required to meet lethality performance standards for both
Salmonella in Sec. 430.2(a) and for E. coli O157:H7 in Sec. 430.2(b).
As discussed under the ``Lethality'' heading above, for fermented RTE
meat and poultry products that contain beef, the Agency is proposing
that processing achieve either specific probabilities of remaining
organisms in 100 grams of finished product, or a 5.0-log10
relative reduction of E. coli O157:H7 throughout the product, which
would achieve those probabilities in a hypothetical, worst case raw
product. FSIS is not proposing this performance standard for fermented
meat and poultry products that do not contain beef.
The Agency tests fermented sausage products for Salmonella, L.
monocytogenes , E. coli O157:H7, and staphylococcal enterotoxin.
Isolation or detection of any of these pathogens and enterotoxin
results in product recall and destruction of product. With the
exception of L. monocytogenes, these pathogens and staphylococcal
enterotoxin have been linked to foodborne illness associated with
fermented sausage products. With regard to S. aureus, the production of
a heat stable enterotoxin (staphylococcal enterotoxin) after it has
achieved a density of at least 10\5\ CFU/g rather than the bacterium
itself is responsible for foodborne illness. Growth of S. aureus is
inhibited by the competitive growth of lactic acid bacteria, such as
lactobacilli and pediococci, which are often used in fermented sausage
products (Refs. 18 and 19, available for viewing by the public in the
FSIS Docket Room).
A suboptimally active fermentation culture or an initial large
number of S. aureus, as has occurred when contaminated starter culture
is used, may result in the growth of S. aureus and the production of
enterotoxin. However, since 1980, the industry has implemented
fermentation controls, and no repeat of the previous type outbreaks has
occurred. Therefore, FSIS is not proposing S. aureus as a reference
organism for these products.
L. monocytogenes is the most frequently isolated pathogen of those
included in the FSIS monitoring program for fermented sausages. Despite
its prevalence in fermented sausage products, no foodborne illnesses
have been linked to L. monocytogenes in fermented sausages. Thus, the
Agency is not proposing that L. monocytogenes be a reference organism
for fermented sausages; however, if the Agency were to find L.
monocytogenes in the finished
[[Page 12600]]
product, the product would be adulterated and subject to recall.
In a Lebanon bologna process, a 3- to 4-log10 reduction
of Salmonella dublin and a reduction of Salmonella typhimurium to
undetectable levels was observed by the end of fermentation if starter
culture was used (Ref. 20, available for viewing by the public in the
FSIS Docket Room). Similarly, Bacus noted that contamination of
fermented meat products with Salmonella most likely results from an
inadequate lactic acid production or a highly contaminated raw product
(Ref. 21, available for viewing by the public in the FSIS Docket Room).
Various studies have shown that fermentation and drying resulted in
about a 2-log10 reduction of E. coli O157:H7 (Refs. 22
through 24, available for viewing by the public in the FSIS Docket
Room). In one study, Glass, et al., reported that E. coli O157:H7
decreased by about 2-log10 CFU/g after fermentation, drying,
and storage at 4 deg.C for 6 weeks following the end of an 18-21 day
drying cycle for a fermented sausage formulation. In another, however,
Faith et al., observed a 5- to 6-log10 reduction of E. coli
O157:H7 in pepperoni sticks following fermentation, drying, and 2 weeks
of storage at an ambient (unrefrigerated) temperature of 21 deg.C.
In one of the few studies that compared the combined effect of
fermentation and drying on both Salmonella and E. coli O157:H7,
Ellajosyula, et al., observed that the reduction of Salmonella and E.
coli O157:H7 in Lebanon bologna was less than 2- log10 after
fermentation to pH 4.7 (Ref. 22, available for viewing by the public in
the FSIS Docket Room). In this study, Salmonella was equally or
significantly (P0.01) less resistant than E. coli O157:H7 to various
combinations of pH levels achieved after fermentation and subsequent
heating at 110 deg.F to 120 deg.F. Fermentation to pH 5.2 or 4.7
followed by heating at 110 deg.F to 120 deg.F for specified times
(e.g., 110 deg.F for 20 hours or 120 deg.F for 3 hours) resulted in a
greater than 7- log10 reduction of both Salmonella and E.
coli O157:H7. This study shows that a final heating step may be
necessary to achieve the proposed reduction of both Salmonella and E.
coli O157:H7 in fermented sausage products.
Salmonella and E. coli O157:H7 have been the cause of foodborne
illnesses linked to fermented sausage products. Although, as noted
above, Salmonella may be less resistant than E. coli O157:H7 to the
processes for the different fermented meat products, it has not been
demonstrated that processes resulting in a 5.0-log10
reduction of E. coli O157:H7 will result in a 6.5- log10 or
7.0- log10 reduction of Salmonella in meat and poultry
products, respectively. Conversely, processes resulting in a 6.5- or
7.0- log10 reduction of Salmonella have not been shown to
produce a 5.0-log10 reduction of E. coli O157:H7. Therefore,
a process for fermented RTE products that contain beef must be
validated for both pathogens.
Cooked and Otherwise Processed Whole or Comminuted Meat Products
As stated above, FSIS already has made final lethality performance
standards for certain RTE meat products, including RTE cooked beef,
corned beef, and roast beef. In this document, FSIS is proposing to
extend these performance standards to all other cooked and otherwise
processed (e.g., cured) meat products. Under this proposal,
establishments would be required to employ processing validated to
achieve specific probabilities (Table 1) that only small numbers of
Salmonella organisms could remain in finished cooked or otherwise
processed, whole and comminuted, RTE meat products. Alternatively, an
establishment could use a process validated to achieve a 6.5-
log10 reduction of Salmonella throughout a finished RTE meat
product.
As with cooked beef, corned beef, and roast beef, the primary
pathogenic microorganism of concern in these other RTE meat products
has been Salmonella. FSIS tentatively finds that the destruction of
Salmonella in these products will result in the destruction of most
other pathogens. FSIS is not proposing to require that any particular
means be used to meet the lethality standard. Cooking, for example,
would not need to be the sole means by which lethality would be
achieved. Other applicable treatments, such as curing or other
controls, could be used in combination with cooking to achieve the
required lethality.
Meat Patties
In the proposal preceding the January 1999 final rule that
established performance standards for certain RTE meat and poultry
products, FSIS identified Salmonella as the target pathogenic
microorganism in fully-cooked, uncured meat patties and proposed a 5-
log10 reduction in Salmonella as the lethality performance
standard. FSIS made a tentative finding that a 5-log10
reduction in Salmonella in cooked, uncured meat patties would
effectively eliminate most other bacterial pathogens of concern.
Notably, compliance with the time/temperature requirements already
contained in the regulations effectively achieved a 5-log10
reduction in Salmonella.
However, FSIS did not make final the lethality performance
standards proposed for RTE comminuted meat patty products. In the
course of developing the final regulation, FSIS determined that a
higher lethality was likely necessary to produce RTE, uncured meat
patties that would pose no health risk to consumers. The Agency could
find no conclusive information demonstrating that the distributions of
bacteria on ground and whole product produced under normal
manufacturing conditions would present comparatively higher or lower
risks to consumers. Furthermore, most, if not all, RTE meat and poultry
products will be manufactured from the same supply of raw product
examined in the FSIS national baseline surveys. So, using performance
standards that would render any hypothetical, worst case raw product
safe should be applicable to all categories of RTE meat and poultry
products.
Consequently, FSIS is proposing to require that establishments
achieve a 6.5-log10 reduction of Salmonella in all RTE meat
products, including RTE meat patties. FSIS believes that many
establishments are achieving this higher lethality already, either
through a cooking step or a combination of treatments. Furthermore, new
and innovative processing technologies, including irradiation of raw
product, should allow establishments to achieve this lethality without
significantly altering the quality of their products through
overcooking.
Cooked and Otherwise Processed Whole or Comminuted Poultry Products
Again, FSIS recently made final lethality performance standards for
all fully cooked, RTE poultry products, such as poultry rolls. In this
document, FSIS is proposing to extend these performance standards to
all other cooked and otherwise processed (e.g., cured) RTE poultry
products. Under this proposal, establishments would be required to
employ processing validated to achieve specific probabilities that only
small numbers of Salmonella organisms could remain in finished cooked
or otherwise processed, whole and comminuted, RTE products that contain
any amount of poultry. Alternatively, an establishment could use a
process validated to achieve a 7-log10 reduction of
Salmonella throughout a finished product.
The primary pathogenic microorganism of concern in these other
[[Page 12601]]
RTE poultry products has been Salmonella. FSIS tentatively finds that
the destruction of Salmonella in these products will result in the
destruction of most other pathogens. For example, Campylobacter jejuni
was not selected as a reference organism in RTE poultry product, even
though it is present at high levels in poultry, because it is generally
recognized as being very sensitive to heat. As with the analogous meat
products, FSIS is not proposing to require that any particular means be
used to meet the lethality standard. For example, various treatments,
such as curing or other controls, can be used in combination with
cooking to achieve the required lethality.
B. Stabilization
In addition to lethality standards, FSIS is proposing that
processing used to produce all RTE products, other than thermally
processed, commercially sterile products, and processing used to
produce partially heat-treated products, meet stabilization performance
standards. The proposed stabilization standards require that
establishments control their production processes to prevent the
multiplication of spore-forming microorganisms. Stabilization is
typically achieved through cooling a product after cooking.
Specifically, the Agency is proposing to require that establishments
producing these products ensure that there is no multiplication of
toxigenic microorganisms, such as Clostridium botulinum, that
potentially would create harmful toxins in the product, and that there
is no more than a 1-log10 multiplication of Clostridium
perfringens within the product.
FSIS is proposing this performance standard because the means
applied to products to bring about the lethality of certain
microorganisms in RTE products, particularly heat treatment, can create
a model environment for the multiplication of spore-forming bacteria.
The processing for many RTE products includes a heat treatment. Spores
of C. botulinum, C. perfringens, and other spore-forming bacteria can
survive cooking and, in fact, can thrive in the warm product following
cooking after competitive microorganisms, such as Salmonella or lactic
acid bacteria, have been eliminated. Anaerobic, non-refrigerated
conditions also facilitate multiplication and growth of these
organisms.
Similarly, during processing, partially-heat treated meat and
poultry products are partially cooked and then cooled, which creates a
model environment for the growth of C. perfringens, C. botulinum, and
other spore-forming, toxigenic bacteria. Cooking by the consumer,
retailer, or other end-user may not eliminate these bacteria or the
toxins that they create in these products. Therefore, it is important
that bacterial growth be controlled in these products to the extent
possible before they reach the end consumer.
The stabilization performance standards are identical to the
standards made final in the January 1999 performance standard
rulemaking, cited above, for RTE products and partially-cooked poultry
and meat patties. The purpose for imposing the no (zero) multiplication
of C. botulinum standard was to ensure that harmful toxins would not be
created in the product during cooling. Toxins are created only when
there is multiplication of C. botulinum, or other spore-forming,
toxigenic bacteria. When spores germinate and reach the outgrowth
stage, even slight temperature abuse to the product can result in cell
multiplication and, if there are sufficient numbers of cells,
subsequent toxin formation. Thus, logically, ensuring no growth of
these bacteria would provide the greatest amount of safety. Microscopic
examination of cells can be used to determine whether cells have
germinated and reached outgrowth stage.
The Agency requests comments on whether the C. botulinum standard
should be no (zero) multiplication as proposed. The Agency also
requests any data to support a tolerance in place of the proposed C.
botulinum standard. The primary purpose for the zero growth standard is
to ensure that harmful toxins will not be created in cooked product
during cooling. If there were cell multiplication during cooling and
sufficient numbers of cells, there could be subsequent toxin formation.
Thus, ensuring no growth C. botulinum provides for the safety of the
product with the greatest amount of confidence.
It is possible that there can be a small amount of C. botulinum
growth within the time of a 1-log10 relative growth of C.
perfringens. If the relative growth of C. botulinum were greater than
zero, but less than some small amount, the affected product could
possibly be considered safe for consumption, provided it is also
assumed that the initial levels of C. botulinum were not high. This
assumption would be a reasonable one, since generally the levels of C.
botulinum in raw meat are low. However, in this situation, the
consequence of the low-level C. botulinum assumption being incorrect
and of the possible toxin production would be severe.
It is possible that compliance with the proposed zero growth
standard for C. botulinum could impose a significant burden on
industry. Because there may be growth of C. botulinum during a 1-
log10 relative growth of C. perfringens, compliance with the
proposed zero growth standard for C. botulinum could effectively
require establishments to meet a more restrictive standard than that
for C. perfringens. Further, demonstrating ``no multiplication'' by
experiments (microscopic examination of cells to determine whether
cells have germinated and reached outgrowth stage) could be expensive.
Also, to the Agency's knowledge, there are not extensive data on which
to build mathematical models for predicting the time before cell
germination or outgrowth and using data from growth curves to develop
predictive models for cell population growth is not propitious for
demonstrating no multiplication. Usually with predictive growth models,
it is very difficult or impossible to show a no occurrence event (zero-
growth) with high probability. Consequently, FSIS requests comment on
this issue, and data to support a possible relative growth tolerance in
place of the zero growth proposed C. botulinum standard.
The proposed stabilization performance standard provides that any
more than 1-log10 multiplication of C. perfringens will
adulterate the product for the following reasons: Viable counts of
10\5\ or greater of C. perfringens/gram in finished product have been
listed by the CDC as one criteria for incriminating C. perfringens as
the causative agent of foodborne illness (Ref. 25, available for
viewing by the public in the FSIS Docket Room), although foods
responsible for C. perfringens outbreaks usually contain at least 10\6\
vegetative C. perfringens cells per gram (Refs. 26 and 27, available
for viewing by the public in the FSIS Docket Room). In the FSIS
microbiological product surveys, some samples were found to contain
more than 10\4\, but less than 10\5\, C. perfringens/gram. It is a
conservative assumption with respect to public health that the great
majority of C. perfringens in the raw product are spores. Heating
activates the spores that, during the cooling, become vegetative cells
that can multiply to hazardous levels. Given that there can be more
than 10\4\ C. perfringens (spores) per gram on raw product, it is
possible that there could be as many as 10\4\ vegetative C.
perfringens/gram of these surviving, after cooking, in the product.
Therefore, the Agency, using the aforementioned CDC criteria as an
upper limit that should not be exceeded, has tentatively
[[Page 12602]]
determined that a limit of no more than 1 log10 growth of C.
perfringens is appropriate to ensure that there would be no more than
10\5\ C. perfringens per gram on the finished product after cooling.
An academic researcher recently suggested to the Agency that the
stabilization performance standard for C. perfringens should apply only
to the surface of intact, whole muscle, RTE products. This researcher
stated that there is no data indicating that the interior of whole
muscle products would ever contain C. perfringens. FSIS requests
comment on this issue, as well as any relevant research data.
V. Listeria monocytogenes
L. monocytogenes grows at low oxygen conditions and refrigeration
temperatures, and survives for long periods of time in the environment,
on foods, in processing plants, and in household refrigerators.
Although frequently present in raw foods of both plant and animal
origin, it also can be present in cooked foods due to post-processing
contamination. Consumption of food contaminated with L. monocytogenes
can cause listeriosis, an uncommon but potentially fatal disease in
newborns, the elderly, and persons with weakened immune systems, such
as those with chronic disease, HIV infection, or persons taking
chemotherapy for cancer. Listeriosis also is a major concern in
pregnant women. Even though symptoms may be relatively mild in the
mother, the illness can be transmitted to the fetus, causing serious
illness or fetal death.
Each year, according to the FDA-FSIS draft risk assessment on L.
monocytogenes (Ref. 28, available for viewing by the public in the FSIS
Docket Room), the bacteria cause an estimated 2,493 cases of
listeriosis. Of these, 2,298 persons are hospitalized and 499 persons
die. The case-fatality rate is high across the whole population--20
deaths per 100 cases of illness. Epidemiologic surveillance data
indicates that the case-fatality rate varies by age, with a higher
case-fatality rate among newborns (1 year) and the elderly (>60 years).
For a full discussion on case-fatality rate, refer to the ``Baseline
Number of Listeriosis Cases and Deaths and the Potential Benefits from
the Proposed Rule'' section in Appendix 1.
Since 1987, FSIS has conducted a microbiological testing program in
which the Agency randomly samples, in-plant, RTE meat and poultry
products produced in federally inspected establishments for L.
monocytogenes, including cooked and fermented sausages, cooked corned
beef, sliced ham and luncheon meats, beef jerky, cooked uncured
poultry, and salads and spreads. FSIS treats RTE products in which L.
monocytogenes is found as adulterated under the FMIA or the PPIA (21
U.S.C. 453(g) or 601(m)). This testing of approximately 7,000 RTE
product samples per year for L. monocytogenes is an indicator of
possible public health problems, but FSIS believes that more
discriminating approaches are in need of development. (A comprehensive
presentation on the FSIS testing program, entitled ``FSIS Ready-to-Eat
(RTE) Sampling in Transition,'' is available from the FSIS Docket
Room.)
During the late 1980's, L. monocytogenes emerged as a problem in
deli meats and other processed food products. FSIS and the Food and
Drug Administration (FDA) worked with processing plants to improve
their procedures and emphasized the ``zero'' tolerance (no detectable
level of viable pathogens permitted) for the pathogen in RTE products.
Between 1989 and 1993, the rate of illness from L. monocytogenes
declined 44 percent. This reduced incidence of foodborne listeriosis
remained level until recently.
In the fall of 1998, state health departments and the CDC began
investigating an increased number of reported cases of illness due to
L. monocytogenes. CDC and state and local health departments identified
the vehicle of transmission as hotdogs and possibly deli meats produced
by one manufacturer under many brand names. On December 22, 1998, in
response to reports of illness, the manufacturer voluntarily recalled
specific production lots of these products that might be contaminated.
Subsequently, CDC and FSIS investigators isolated the outbreak strain
of L. monocytogenes from an opened and a previously unopened package of
hotdogs manufactured by one plant. In addition, a different strain of
the pathogen was isolated from unopened packages of deli meats produced
at the same plant. CDC has since reported 101 illnesses, 15 adult
deaths, and 6 stillbirths or miscarriages associated with this
outbreak.
With this outbreak in mind, on May 7, 1999, the FDA, in
consultation with FSIS, announced plans to conduct a risk assessment to
determine the prevalence and extent of exposure of consumers to
foodborne L. monocytogenes and to assess the resulting public health
impact of such exposure (64 FR 24661). FDA and FSIS published this
draft risk assessment for comment on January 19, 2001 (Ref. 28,
available for viewing by the public in the FSIS Docket Room).
Significantly, it identifies certain RTE meat and poultry products,
among the food products assessed, as posing a relatively high health
risk of listeriosis to consumers because of potential RTE product
contamination by L. monocytogenes.
In this document, FSIS is proposing regulatory requirements and
considering other options to address the relatively high risk ranking
of these RTE meat and poultry products. Significantly, the draft risk
assessment was designed to estimate the predicted relative risk of
serious illness and death that may be associated with consumption of
different types of ready-to-eat foods. The draft risk assessment
document, unlike more complete risk assessments, did not attempt to
account for the level or sources of contamination of ready-to-eat meat
and poultry products in a farm-to-table approach such as during
processing in Federally inspected facilities. Rather, the draft risk
assessment accounted for the retail foodborne exposure to human
listeriosis (i.e., after the ready-to-eat product is out of the control
of the Federal establishment). The data included in the draft risk
assessment were gleaned from both international and domestic sources,
with FSIS providing a substantial amount of data from its various
microbiological programs associated with Federally inspected meat and
poultry. The draft risk assessment was designed to address data only
associated with listeriosis, providing a distinction between foodborne
illness associated with mild, flu-like symptoms (referred to as
listerial gastroenteritis) and severe and life-threatening outcomes
(i.e., listeriosis). For this reason, some Federally inspected meat and
poultry products were not addressed in the draft risk assessment (e.g.,
canned meat and poultry and partially- and fully-cooked meat patties).
Except for the canned products and the meat patties, FSIS believes that
the risk assessment addresses the remaining meat and poultry products
contained in this proposed rule (i.e., frankfurters, dry/semi-dry
fermented sausages, deli meats, and pate and meat spreads).
A. Proposed Requirements for Controlling L. monocytogenes
In the risk assessment, FDA and FSIS note that although
pasteurization or cooking by an establishment will kill L.
monocytogenes, there is risk of recontamination of RTE foods during
processing, after the lethality is applied (Ref. 28, (Interpretive
Summary, p. 24; Exposure Assessment, p. 24), available for viewing by
the public in the FSIS
[[Page 12603]]
Docket Room). Significantly, FDA, FSIS and other authors point out,
that deli meats in particular are most likely to be recontaminated by
L. monocytogenes after cooking, during processing such as slicing (Ref.
28 (p. 167); Ref. 32; Ref. 33; all available in the FSIS Docket Room),
although no data were available to distinguish between the risks of
slicing product in a retail environment rather than an official
establishment.\3\
---------------------------------------------------------------------------
\3\ Although pate and meat spreads also are identified in the
draft FDA/FSIS risk assessment as having high predicted relative
risk of causing listeriosis on a per serving basis, much of the
reported foodborne outbreaks are associated with foreign
populations. However, FSIS is aware of one foodborne outbreak in the
U. S. involving pate produced in a federally inspected facility in
1999. In this outbreak, pate was prepared by cooking the product in
open containers and then over-wrapped with film. Product was then
distributed to multiple states and sold in gourmet shops. The pate
was implicated as the food vehicle for L. monocytogenes. L.
monocytogenes was cultured from an unopened package of pate at
retail. FSIS was not able to determine whether L. monocytogenes was
present in the unopened package as a consequence of underprocessing
(i.e., inadequate lethality) or post-lethality contamination.
---------------------------------------------------------------------------
FSIS is proposing to require that all establishments that produce
RTE meat and poultry products conduct environmental testing of food-
contact surfaces for Listeria spp., after lethality treatment and
before final product packaging, unless they have identified L.
monocytogenes as a hazard reasonably likely to occur and so have
incorporated into their HACCP systems one or more controls validated to
eliminate it from their products. This testing will verify that an
establishment's Sanitation Standard Operating Procedures (Sanitation
SOPs) are preventing direct product contamination by L. monocytogenes
after the lethality treatment, thus addressing the risk assessment
assertion that RTE foods often are recontaminated by L. monocytogenes
after lethality is applied.
After an establishment finds one of its food contact surfaces to be
positive for Listeria spp., it must take corrective actions defined in
its Sanitation SOP that must include product testing, as well as any
other activities that it deems necessary to determine and demonstrate
that the affected lot or lots of product are not adulterated with L.
monocytogenes. The establishment must have in place procedures: to
determine which lots of product might be affected; to hold, sample, and
test that product; and to dispose of affected product appropriately.
Establishments that have identified L. monocytogenes as a hazard
reasonably likely to occur in their HACCP plans and that have
consequently established CCPs for L. monocytogenes would be exempt from
this mandatory testing requirement. For example, establishments that
produce thermally processed, commercially sterile, hermetically-sealed
(canned) products should be relatively unaffected by this proposed
requirement. Neither should many other establishments that produce meat
and poultry products that receive lethality treatment in their final
packaging, such as beef cooked in an impervious bag. In most cases,
these and similar establishments would need only to modify their HACCP
plans to reflect that L. monocytogenes is likely to occur at some point
during their processing, but their existing CCPs for lethality would
eliminate the pathogen.
FSIS believes that L. monocytogenes contamination is reasonably
likely to occur in the production of all RTE meat and poultry products.
On May 26, 1999, FSIS published in the Federal Register a Notice
advising manufacturers of RTE meat and poultry products of the need to
reassess their HACCP plans to ensure that the plans are, in fact,
adequately addressing L. monocytogenes (64 FR 28351). If this
reassessment revealed that L. monocytogenes was a hazard reasonably
likely to occur in an establishment's production process, the Notice
stated that the establishment must address the hazard in its HACCP
plan.
FSIS acknowledges, however, that there may be certain processing
environments in which L. monocytogenes is not a hazard reasonably
likely to occur. In such environments, verification through testing
that the establishment's Sanitation SOP is controlling Listeria spp.
would be necessary, at a minimum.
Notably, Tompkin, et al., have recommended plant-wide environmental
testing that
* * * should focus on a non-pathogenic indicator such as
Listeria spp. or Listeria-like organisms * * * , because these
organisms will be found more frequently in the environment than L.
monocytogenes and because test results are available more quickly.
(Ref. 29, available for viewing by the public in the FSIS Docket
Room)
FSIS agrees, although the Agency is proposing to require only the
testing of food contact surfaces. Were an establishment to find
Listeria spp. on a food contact surface, that finding would be
indicative of a sanitation problem that could cause product
adulteration, even though the contaminant on the surface may not be L.
monocytogenes.
FSIS is proposing to require that establishments without HACCP
controls for L. monocytogenes test food contact surfaces for Listeria
spp. at one of the following frequencies, depending on establishment
size:
If the plant is large, at least four tests, per line, per
month;
If the plant is small, at least two tests, per line, per
month;
If the plant is very small, at least one test, per line,
per month;
FSIS is proposing to employ the same Small Business Administration
(SBA) size standards that it used to determine the implementation dates
for its HACCP/Pathogen reduction final rule. Large establishments would
be defined as all establishments with 500 or more employees. Small
establishments would be defined as all establishments with 10 or more
employees but fewer than 500. Very small establishments would be
defined as all establishments with fewer than 10 employees or annual
sales of less than $2.5 million.
These frequencies ensure a very minimal amount of testing and,
because they are progressive, mitigate some of the economic impact on
small businesses. FSIS has not been able to correlate risk of product
contamination with production volume or establishment size. However,
assuming that large establishments produce a greater volume of product
than do small establishments, and that a large insanitary establishment
would be more likely to contaminate more product and thus pose more
risk to the public health, FSIS is proposing to require large plants to
test more often. Because these frequencies are not based on research
but represent what the Agency believes to be minimal levels, FSIS
requests comment on these proposed testing frequencies, their efficacy
in preventing product adulteration, and the costs to industry. FSIS
also specifically solicits information the current state of knowledge
about the relationship between Listeria spp. on food contact surfaces
and L. monocytogenes on the product; the appropriate timing of the test
(pre-start-up or post-start up), seasonality and other risk based
considerations that might be important in creating effective testing
protocols; and, the testing methodologies that are currently available
and the current practice and use of the tests by industry or others
Agencies. FSIS will use the information to develop testing frequencies
and methodologies that protect the public health, while providing
flexibility to establishments. FSIS plans to hold one or more technical
conferences during the comment period for this proposed rule, at which
these testing issues and other can be discussed. FSIS plans to provide
for discussion of the latest testing
[[Page 12604]]
methodologies, including those used by other Federal Agencies and
industry, as well as an ongoing ARS study on the testing of intact RTE
product for L. monocytogenes.
FSIS is proposing to require that establishments take certain
actions after food contact surfaces test positive for Listeria spp.
After an establishment finds one of its food contact surfaces to be
positive for Listeria spp., it must take the corrective actions defined
in its Sanitation SOP. According to Sec. 416.15(a), Sanitation SOP
corrective actions may include ``procedures to ensure appropriate
disposition of product(s) that may be contaminated, restore sanitary
conditions, and prevent the recurrence of direct contamination or
adulteration of product(s).''
The presence of Listeria spp. may be indicative of serious
sanitation problems, especially if positive findings recur. Further,
Listeria spp. positives on food contact surfaces indicate a potential
for product adulteration by L. monocytogenes. Therefore, an
establishment's corrective actions following a positive must include
product testing and any other activities that it deems necessary to
determine and demonstrate that the affected lot or lots of product are
not adulterated with L. monocytogenes. The establishment must have in
place procedures: to determine which lots of product might be affected;
to hold, sample, and test that product; and to dispose of affected
product appropriately. FSIS acknowledges that some establishments would
have to modify their Sanitation SOP corrective actions to include these
elements.
FSIS requests comments on the proposed testing provisions and any
data that would support the approach proposed. FSIS requests comments
concerning whether Listeria positive test results on different food
contact surfaces should be treated differently (e.g., positives on food
contact surfaces that have undergone listericidal treatment versus
other food contact surfaces). FSIS also requests comments on whether it
should establish more specific requirements regarding product sampling
and testing following a finding of Listeria spp. on a food contact
surface. And, FSIS request comment on whether it should allow
establishments that find Listeria spp. on a food contact surface to
determine if the positive sample is in fact L. monocytogenes before
having to initiate product testing.
If a sampled lot is found to be positive for L. monocytogenes, and
is already in commerce, it will be subject to recall. Further, if
product is found to be positive for L. monocytogenes, the establishment
likely will need to establish controls within its HACCP plan for L.
monocytogenes. Also, reoccurring positives for non-pathogenic Listeria
spp. may indicate that the establishment has a serious sanitation
problem, even if L. monocytogenes is never found. FSIS enforcement
action will vary depending on the establishment's efforts to correct
its sanitation and processing problems and its disposition of affected
product. FSIS acknowledges that establishments that develop one or more
CCPs to control L. monocytogenes would not necessarily be testing for
Listeria spp. to verify the efficacy of their Sanitation SOPs and
requests comments on this issue.
The two provisions for Listeria control contained in this proposed
rule (i.e., Sanitation SOPs and HACCP) require specific daily action
regarding controls to ensure product is not adulterated. FSIS does not,
at this time, consider control programs outside of Sanitation SOPs and
HACCP to be sufficient for controlling hazards associated with post-
lethality contamination with Listeria in the manufacturing of RTE meat
and poultry products microbiological results and documentation of
corrective and preventive actions generally are not provided to FSIS.
FSIS has received a petition from a group of industry organizations
regarding the issue of prerequisite programs. FSIS will address this
issue separately from this proposed rule. In addition, FSIS will be
further addressing this issue as part of its response to an Office of
Inspector General report on HACCP implementation (Ref. 35, available in
the FSIS Docket Room and at the FSIS web page, http://www.fsis.usda.gov).
With any final action FSIS will publish guidance to establishments
regarding testing frequencies and methodologies and appropriate
corrective actions following food-contact surface positives. FSIS also
will publish guidance regarding available listericidal interventions
establishments can implement as CCPs. FSIS expects to make draft
guidance documents available after publication of this proposed rule
and as information becomes available in order to provide establishments
with appropriate guidance regarding sampling and testing to verify
sanitation procedures. FSIS will consider comments on this draft
guidance in developing any final regulations. These draft guidance
materials will be clearly identified as guidance materials and not as
regulatory requirements. FSIS expects to post these guidance materials
to the FSIS web page (http://www.fsis.usda.gov) and will make the
documents available free of charge via the Constituent Update (see
section XIV Additional Public Notification) and the FSIS Docket Room.
Eventually, FDA and FSIS may allow establishments to treat RTE
products with ionizing radiation. If applied within a HACCP system,
irradiation could eliminate L. monocytogenes from a RTE product. FSIS
also is aware that industry is developing edible, antimicrobial
coatings that could be applied to RTE meat and poultry after cooking or
other lethality treatments. However, FDA has not yet approved any of
these coatings for meat and poultry. FSIS also will make available its
directives to inspection personnel that will explain how to verify
whether an establishment has implemented a testing regime sufficient to
verify the efficacy of Sanitation SOPs in preventing direct product
contamination by L. monocytogenes prior to the effective date of any
final regulation.
Finally, FSIS notes that on January 13, 2000, it received a
petition from the Center for Science in the Public Interest (CSPI)
requesting that FSIS require all establishments that produce RTE meat
and poultry products to conduct environmental testing for Listeria spp.
and product testing for L. monocytogenes. FSIS will respond to this
petition completely along with other public comments submitted in
response to this proposal. CSPI also requested that FSIS require RTE
products produced by establishments without CCPs for L. monocytogenes
to bear warning labels. FSIS discusses this request in the following
section and also will respond more completely in any final action that
stems from this proposal.
B. Shelf-Life and Labeling
In the petition discussed above, CSPI also requested that FSIS
require establishments that have not incorporated microbial testing for
L. monocytogenes into their HACCP plans to label their products so as
to alert ``consumers that the products may be contaminated and should
not be eaten by at-risk consumers without reheating.'' FSIS will
respond to this petition fully in any final action stemming from this
proposed rule.
FSIS considered, but did not propose in this document, the option
of requiring that the labeling of certain RTE meat and poultry products
state the product's shelf-life, and that shelf-life be based on product
safety (``use-by'' date labeling). If after processing, a RTE product
that could support growth of L. monocytogenes were to be
[[Page 12605]]
recontaminated by even a single cell of the pathogen, that cell could
multiply during storage at refrigeration temperatures to levels that
could pose a risk of illness to vulnerable individuals (e.g., pregnant
women, the elderly, or the immunocompromised). ``Use-by'' date labeling
may provide further reductions in risk of listeriosis if the labeling
increases the likelihood that high-risk RTE products would be consumed
before very low levels of L. monocytogenes, undetectable at the
establishment, could grow to dangerous levels.
FSIS is not proposing to require ``use-by'' dates on the labels of
any RTE products at this time because further information regarding the
potential effects of use-by date labeling is needed. For instance,
there is sparse information on current consumer understanding of use-by
date labeling, the likelihood that consumer practices will change, and
on the effect of changes in consumer behavior on listeriosis cases.
Similarly, FSIS currently does not possess all the data necessary to
assess the reduction in risk that will occur from this change. Also,
FSIS does not have information concerning how use-by date labeling
would affect the production and shipment patterns of labeled ready-to-
eat meat and poultry products and the structure of the industry. FSIS
requests comments on all of these issues and on the feasibility of
requiring ``use-by'' date labeling on RTE meat and poultry products.
Significantly, FDA and FSIS will present ``use-by'' date labeling
issues to NACMCF for their review. FSIS has conducted a more thorough
analysis of use-by date labeling in Appendix 1, Compliance with
Executive Order 12866, under the ``Alternatives'' section.
Related to ``use-by'' date labeling is the issue of consumer
preparation of hotdogs and similar RTE foods. In the draft risk
assessment, FSIS and FDA state that ``the factor that has the greatest
effect on the predicted health impact of frankfurters is the extent of
post-retail reheating by the consumer'' (Ref. 28 (p. 161); Ref. 33; Ref
34; all available in the FSIS Docket Room). Obviously, testing for L.
monocytogenes in the establishment will not directly affect consumer
preparation of frankfurters or other RTE foods. However, if in-plant
testing verifies that establishments are effectively preventing the
contamination of frankfurters and other RTE products by L.
monocytogenes, consumer preparation or handling of these RTE products
will no longer be so inappropriately crucial to ensuring their safety.
Furthermore, once FSIS is more confident that establishments are
adequately addressing the safety of their RTE products, especially for
frankfurters and deli meats, throughout the shelf-life of their
products, FSIS will consider modifying its consumer message to
vulnerable populations and remove the current recommendation for these
populations to either not consume these RTE products or to fully re-
cook these products before consuming them.
Finally, as discussed below, FSIS is proposing that the labeling of
RTE products state that the product requires refrigeration after
opening, as applicable. Current regulations require that labels of
perishable products include such instructions, but the Agency is
proposing to expand the required label instructions to include RTE
shelf-stable products that require refrigeration after opening. FSIS
also considered proposing to change the ``keep refrigerated'' and the
``refrigerate after opening'' statements (see proposed in
Secs. 317.2(k) and 381.125(a)) to reflect the guidance developed by FDA
on February 24, 1997 (62 FR 8248). In the guidance, these statements
were modified to read ``Important Must Be Kept Refrigerated to Maintain
Safety'' or ``Important Must Be Refrigerated After Opening To Maintain
Safety.'' FDA provided this guidance in response to the recommendations
from the NACMCF, the National Food Processors Association, the
Association of Food and Drug Officials, and the CDC regarding the
labeling of foods that need refrigeration. FDA stated in this policy
document that ``[t]his guidance, which represents FDA's policy on
adequate safe handling instructions for food, should reduce the
likelihood of temperature abuse of certain foods by consumers, and it
is intended to reduce the potential for foodborne illness and death.''
FSIS is not proposing to require these provisions because further
information regarding the potential effects of this labeling is needed.
FSIS requests comment on the statements and their appropriateness for
RTE meat and poultry products which are not shelf stable.
VI. Thermally-Processed, Commercially Sterile Products
Thermally-processed, commercially sterile meat and poultry products
generally have a water activity above 0.85 and have received a thermal
process either before or after being packed in a hermetically sealed
container. They are typically canned, although other types of packaging
can be used. The thermal process renders the product shelf-stable and
commercially sterile, that is, free of microorganisms capable of
growing in the product in nonrefrigerated conditions (temperatures over
50 deg.F or 10 deg.C), under which the product will be held during
distribution and storage, until consumed.
Sections 318.300 to 318.311 and 381.300 to 381.311 of the
regulations prescribe the exact means by which official establishments
must produce thermally processed, commercially sterile meat and poultry
products. These regulations include detailed requirements regarding
containers and container closures, equipment specifications and
operations, measurements and instrument calibration, recordkeeping and
record review, corrective actions in the case of processing deviations,
finished product inspection, personnel training, and product recalls.
They also require that official establishments implement process
schedules validated to render treated meat and poultry commercially
sterile and shelf-stable. These process schedules must be developed or
validated by processing authorities, persons or organizations with
expert knowledge of thermal processing requirements for foods packaged
in hermetically sealed containers.
Processors that produce thermally processed, commercially sterile
meat and poultry products also must meet all other regulations
applicable to meat and poultry establishments, such as sanitation and
HACCP requirements. Significantly, however, under Sec. 417.2(b)(3),
FSIS exempts producers of thermally processed, commercially sterile
products from addressing in their HACCP plans ``food safety hazards
associated with microbiological contamination.'' FSIS granted this
exemption in response to comment on the proposal to require HACCP
systems:
FSIS agrees that the microbial hazards associated with canned
meat and poultry products are eliminated by complying with the
regulations in 9 CFR Secs. 318.300-311 and 381.300-311. These
regulations are based on HACCP concepts and provide for the analysis
of thermal processing systems and controls to exclude microbial
hazards. Accordingly, the final rule provides that HACCP plans for
thermally processed/commercially sterile products do not have to
address the food safety hazards associated with microbiological
contamination if the product is produced in accordance with the
canning regulations. However, because the current regulations
exclusively address microbial hazards, processors of canned meat,
meat food and poultry products must develop and implement HACCP
plans to address chemical and physical hazards that are reasonably
likely to occur.
(61 FR 38824)
[[Page 12606]]
The regulations governing the processing of thermally processed,
commercially sterile meat and poultry products are, in a sense, a
prescribed HACCP system that official establishments must implement
along with controls to address other hazards not addressed in those
regulations. Maintaining this prescriptive regulatory approach to a
single category of meat and poultry products, however, is inconsistent
with FSIS's other regulatory initiatives intended to grant industry
maximum flexibility to innovate in processing, while clarifying
industry's responsibility and accountability for the safety of meat and
poultry products. Therefore, FSIS is proposing to replace the
prescriptive regulations governing thermally processed, commercially
sterile products with performance standards. FSIS is also proposing to
remove Secs. 320.2(b)(6) and 381.175(b)(3) because they refer to
recordkeeping requirements in the canning regulations that FSIS is
proposing to eliminate. FSIS has discussed this proposed action in
previous documents, including the final rule that established the HACCP
requirements:
The current canning regulations contain numerous prescriptive
features, including extensive FSIS involvement in the decision
making process, that are inconsistent with the philosophy underlying
HACCP. In the advance notice of proposed rulemaking ``FSIS Agenda
for Change: Regulatory Review'' (60 FR 67469; December 29, 1995),
FSIS stated its intention to convert the canning regulations to
performance standards, which are more consistent with HACCP.
(61 FR 38824)
FSIS is proposing lethality performance standards to ensure the
elimination or control of the pathogen C. botulinum in thermally
processed, commercially sterile meat and poultry products. FSIS also is
proposing a revised requirement ensuring the commercial sterility of
these products. This requirement is consistent with the existing shelf-
stability/commercial sterility definitions in Sec. 318.300(u) and
381.300(u) and the FDA regulations for commercial sterility of canned
products contained in 21 CFR 113.3(e).
A. Lethality
FSIS is proposing different lethality performance standards,
depending on whether the product is a low-acid product or a product in
which pathogen growth is controlled by acidification or factors other
than the thermal process. A low-acid, thermally processed, commercially
sterile product is a canned or other hermetically sealed product in
which any component has a pH value above 4.6 and a water activity above
0.85. Such products include canned poultry and canned uncured meat
products, such as beef stew and chili con carne, and certain canned
cured meats, such as vienna sausages and corned beef. An acidified
thermally processed, commercially sterile product is a canned product
that has been formulated or treated so that every component of the
finished product has a pH of 4.6 or lower, usually within 24 hours
after the completion of the thermal process, but sometimes longer. Such
products include spaghetti sauce with meat and meat with tomato sauce.
In addition, there are some canned, hermetically sealed products in
which pathogen growth is controlled by factors other than the thermal
process, such as a heat treatment in combination with salt or nitrite
(e.g., canned luncheon meat).
FSIS is proposing to require that an establishment's process for
producing a low-acid canned product result in a probability of
10-9 or less that there are spores of C. botulinum in a
container of the product that are capable of growing, assuming an
initial load of 1000 spores per container. Alternatively,
the establishment may achieve a 12-log10 reduction of C.
botulinum. A process carried out for a certain number of minutes at a
given temperature that reduces C. botulinum by a factor of 12 decimal
units, often referred to in the canning industry as a ``botulinum
cook,'' is one that meets a 12-log10 standard, also known as
a 12-D standard. A 12-D process has been demonstrated to be sufficient
to destroy C. botulinum in a low-acid canned product. Under this
proposal, the level of safety that a process other than a 12-D process
would have to achieve would be a probability of 10-9 or less
of any C. botulinum spores in a container of the product that are
capable of growing, assuming an initial load of 1000
organisms.
The 12-D concept arose from studies on the thermal resistance of C.
botulinum conducted in the early 1920's by scientists of the National
Canners Association (predecessor of the National Food Processors
Association). These scientists inoculated a phosphate buffer with
spores of the most heat-resistant strain of the organism then known.
They determined, by extrapolating from the exponential survival curve
for the organism, the temperature and duration of the heat process
necessary to reduce the population from 6 x 1011 spore/
unit to less than one spore/unit. Subsequent studies on products
inoculated with C. botulinum and other organisms essentially confirmed
the results of these studies.
These products undergo a botulinal cook to achieve an acceptable
safety level. It should be noted that the intensity of the process is
not related to the actual number of C. botulinum organisms that may be
in the product. That number is usually very low in a meat product (less
than a spore per kilogram). So the 12-D process provides a tremendous
safety margin to consumers.
The level of safety achieved by a 12-D process in low-acid canned
products is understood by thermal processing experts to be a
10-9 probability of any live botulinum organisms (Refs. 30-
31, available for viewing by the public in the FSIS Docket Room). That
means that the odds are one in a billion that a can is contaminated
with the organism. This result is arrived at by assuming that a process
that reduces botulinum spores by 10-12--a 12-D process--is
applied to a test pack of product inoculated with 103 spores
per unit. The probability that any containers that are subjected to the
process harbor spores capable of growing is 10-9. Thus, FSIS
is proposing to require that establishments producing low-acid products
achieve a probability of 10-9 or less that there are spores
of C. botulinum in a container that are capable of growing or a 12-
log10 reduction of C. botulinum.
FSIS is proposing to require that the processing of acidified low-
acid products and of some cured products and other canned products in
which pathogen growth is controlled by factors other than the thermal
process, prevent multiplication of C. botulinum. For these products,
processing (formulation and environment) must prevent growth rather
than achieve any specific decimal reduction of C. botulinum. Therefore,
there can only be one level of performance for acidified low-acid
products and other thermally processed, commercially sterile products
in which pathogen growth is controlled by factors other than the
thermal process--prevention of C. botulinum multiplication. However,
the prevention of multiplication can be achieved by a variety of
methods.
Acidified low-acid meat and poultry products are generally
acidified by ingredients, such as tomato sauce, or by additives, such
as glucono-delta-lactone, which increase the acidity (i.e., lower the
pH) of the products. The acidity of these products (pH at or below 4.6)
is sufficient to prevent the germination of C. botulinum and other
bacterial spores. The heat processing of these products does not
include a botulinum cook or retort but is achieved at pasteurizing
[[Page 12607]]
temperatures below 100 deg.C. (212 deg.F.) and is sufficient to kill
or inactivate molds, yeasts, and vegetative bacterial cells. This
processing is important because, if canned acidified foods are
contaminated by yeast or mold, the pH of the foods could be raised
above 4.6, thus providing an environment for possible C. botulinum
growth. These products--spaghetti sauce, for example--can be heat-
treated before being placed in a container (i.e., hot-filled) rather
than retorted and still achieve commercial sterility.
Other thermally processed, commercially sterile products can be
rendered commercially sterile by a heat treatment in combination with
other factors. For example, the shelf-stability of canned luncheon meat
is a combined effect of heat treatment, the presence of nitrite and
salt, and a low pre-processing level of C. botulinum. A 10-percent salt
concentration or about 2 tenths of a percent of nitrite in the product
formulation is usually considered sufficient to inhibit growth of the
organism. The shelf-stability of dried meat-filled pasta results from a
heat treatment and a water activity of less than 0.92 in the product.
(Water activity is a measure of free moisture, or water available for
microbial growth, in a food; the lower the number, the less moisture.)
C. botulinum and other spore-forming organisms cannot grow at water-
activity levels below 0.93. The heat treatment of these products
destroys the vegetative cells of both pathogenic and nonpathogenic
organisms, and the outgrowth of spores is prevented by the other
inhibiting factors.
B. Commercial Sterility
FSIS also is proposing a specific requirement that all thermally
processed, commercially sterile products, in fact, be commercially
sterile and hermetically sealed. This requirement is consistent with
the existing shelf-stability/commercial sterility definitions in
Sec. 318.300(u) and 381.300(u) and the FDA regulations for commercial
sterility of canned products contained in 21 CFR 113.3(e). A commercial
sterility requirement is necessary to protect against both food-safety-
related and non-food-safety-related forms of contamination.
Product that has undergone more processing than necessary to
protect health, but less than necessary for commercial sterility, is
safe, but it may not be stable. The stability of the product is usually
determined by incubating the product for a certain time at a given
temperature (e.g., 10 days at 955 deg.F), then sorting 100
percent of the product to locate any swelling or abnormal-appearing
containers. Products that are shown to have undergone less processing
than necessary to protect health are potentially hazardous and are
removed from commerce.
The proposed commercial sterility requirement would mean that the
process for a canned product, in addition to reducing or inactivating
C. botulinum spores, would have to ensure a reduction or inactivation
of spore-forming organisms sufficient to guarantee commercial
sterility. A process that ensures a 10-9 probability of
contamination by C. botulinum spores will not provide the same
probability of destruction of the most heat-resistant mesophilic
(optimum growth, 20-45 deg.C) anaerobes, such as Clostridium
sporogenes, or thermophilic (optimum growth, 50-65 deg.C) organisms,
such as B. stearothermophilus. Recommended processes for preventing
contamination by such nonpathogenic organisms typically ensure a
probability of no spore-forming units in the range of 10-6.
FSIS is proposing a general and not a quantitative standard for
commercial sterility in this document but requests comment on whether a
quantitative standard is necessary.
FSIS considers a commercial sterility standard to be appropriate,
among other reasons, because the Agency is obligated under the statutes
it enforces to administer programs aimed at preventing all forms of
adulteration of meat and poultry products. The Agency's current thermal
processing regulations are intended to ensure that canned and other
thermally processed products are not adulterated.
Hermetic sealing of a container protects the product and prevents
microorganisms or other potential contaminants from entering the
container. If the container seal is inadequate, the product may no
longer be microbiologically stable. C. botulinum or spoilage organisms
could contaminate the product during container cooling or storage. The
product could become adulterated because of spoilage, an economic
concern, or because of C. botulinum, a public health concern. For this
reason, FSIS considers appropriate, and is proposing, a hermetic
sealing requirement. In Sec. 430.5(c), FSIS is proposing that the seal
be airtight to protect the contents of the container from the entry of
microorganisms.
C. Training
Several industry groups and other interested parties have expressed
reservations concerning any replacement of the existing regulations for
thermally processed, commercially sterile products with performance
standards. The complexity of the canning process, as well as the
virulence of C. botulinum toxin which can form in canned products, have
been cited as reasons for maintaining the existing, prescriptive
regulations. Significantly, FSIS is proposing to retain, in new
Sec. 430.5(d), the requirement that all operators of processing systems
for commercially sterile meat and poultry products and container
closure technicians be under the direct supervision of a person who has
successfully completed a school of instruction that is generally
recognized as adequate for training supervisors of canning operations.
FSIS specifically invites comment as to whether and in what form the
existing requirements for thermally processed, commercially sterile
meat and poultry products should be retained. If the Agency does
replace the current regulations with the proposed performance
standards, it plans to issue a revised version of the current
regulations as compliance guides for industry.
VII. Elimination of Trichina Treatment Requirements
FSIS also is proposing to remove the provisions for the prescribed
treatment of pork and of products containing pork to destroy trichina
(Trichinella spiralis) under Sec. 318.10. FSIS requires establishments
to eliminate trichina from numerous RTE products under these
regulations. If this proposal is made final, the specifically
prescribed treatments will be unnecessary, since compliance with the
proposed lethality performance standards should also render RTE
products free of trichina.
With regard to heat-treated, RTE products containing pork, the
required treatment to destroy trichina would no longer be needed
because if the process used meets the proposed performance standards
for Salmonella, the process should eliminate any live trichina. For
dried, salt-cured, or fermented products, the implementation of the
lethality requirements for Salmonella and E. coli 0157:H7 would also
likely destroy trichina. However, because there are no published
studies comparing the lethalities of Salmonella or E. coli 0157:H7 to
the destruction of trichina in dried, salt-cured, or fermented
products, the Agency cannot state with absolute certainty that the
proposed lethalities for these products would also destroy any live
trichina. Thus, if the establishment identifies trichina as a hazard
reasonably likely to occur, the establishment would have to ensure that
[[Page 12608]]
the process used effectively eliminates this hazard.
Several products that are not RTE also must be treated to destroy
trichina under Sec. 318.10. FSIS is proposing to remove the trichina
treatment provisions for these products because they represent overly
prescriptive provisions that are contrary to HACCP. By removing these
provisions for all products, the Agency would provide establishments
with flexibility to determine whether they need to treat the products
to eliminate trichina. If an establishment identifies trichina as a
hazard reasonably likely to occur in a process, it must address
trichina in its HACCP plan.
The Agency prescribes trichina treatment for certain not-RTE
products that may be eaten rare or undercooked because of their
appearance. These products may appear to have been cooked because they
contain ingredients such as wine, paprika, or curing agents.
Significantly, however, packages of raw meat and poultry products must
bear the safe handling label. The safe handling instructions
regulations (9 CFR 317.2(l) and 381.125(b)) require that all meat and
poultry products that are not RTE bear safe handling instructions on
the label. By following the ``cook thoroughly'' portion of the safe
handling instructions, the consumer should eliminate possible bacterial
contaminants and any trichina present in the product. According to the
FSIS Meat and Poultry Hotline and industry sponsored consumer surveys,
the perception that pork may be infected with trichina continues to be
a common food safety concern to American consumers, so FSIS has some
confidence that consumers will cook these products thoroughly.
FSIS is examining the need for future rulemaking to address these
pork products and other similar non-pork products that may be eaten
without adequate cooking because of their appearance. The Agency is
considering requiring conspicuous labeling that would identify these
products as not-RTE and provide more specific instruction to consumers
regarding safe handling and preparation.
The requirements in Sec. 318.10 for treating pork products that may
contain trichina originated in the early part of the 20th Century. At
that time T. spiralis was a serious foodborne problem caused by
consumption of underprocessed products. In response, the USDA
implemented rules that prescribed treatments, in part based on USDA
research, to destroy trichina in RTE products. At the time these
prescribed trichina treatments were implemented, the causes of
bacterial foodborne illnesses were not fully characterized or
recognized. Thus, USDA was prescribing treatments to address the best-
known foodborne hazard and believed a trichina-free product was indeed
safe-to-eat. In subsequent decades, as other foodborne pathogens were
recognized and characterized, these prescriptive regulations were not
modified to address those hazards.
For example, other organisms may be biological hazards in pork,
such as Toxoplasma gondii and Taenia solium. These organisms must also
be eliminated from certain products, including RTE products, in order
for the product to be safe. However, the Agency has not prescribed the
methods of elimination of these and other similar potential hazards in
pork. FSIS has determined that these and other hazards, like trichina,
should be addressed under HACCP plans rather than through prescriptive
regulations.
All establishments producing products containing pork should assess
whether trichina is a hazard reasonably likely to occur in their
processes. If it is, they should address this hazard in their HACCP
plans. Establishments should assess whether the product should be
treated for elimination of live trichina, whether special cooking
instructions are necessary on the label of the product, or whether the
safe handling label is sufficient to ensure that the product is cooked
to temperatures necessary to eliminate any possible live trichina. The
establishment's decision concerning whether to treat the product for
trichina or to include special cooking instructions on the label may be
based on how the consumer typically prepares the product or the
likelihood of the product's being confused with a RTE product.
Establishments that produce pork products should consider whether
their suppliers have taken measures to prevent trichina infection of
their herds. FSIS has entered into an agreement with other USDA
agencies, two pork processors, and the National Pork Producers Council
to pilot test a program that will identify risk factors for trichina
infection and certify production units that voluntarily adopt practices
to reduce or eliminate those risks. Pork producers who wish to be
certified will agree to implement management practices that prevent a
herd from becoming trichina infected. Qualified accredited
veterinarians, trained by the USDA Animal and Plant Health Inspection
Service (APHIS), will audit production units to ensure that practices
are being followed. APHIS will subsequently review audit findings and,
if satisfactory, issue a Trichinae Certification to the herd. In
addition, APHIS will track the status of all certified herds and
conduct spot audits to ensure program integrity. Herds owners must
renew certification status every 15 months by satisfactorily completing
another audit.
When pigs are submitted for slaughter as trichina certified,
processors will check the APHIS database to ensure that the premises of
origin are certified and in good standing. A representative sample of
trichina certified pigs, as provided by the National Trichina
Certification Program Standards, will be tested for the presence of
trichina to ensure program integrity . FSIS will verify that processors
properly check status of pigs, test samples as required, and maintain
adequate animal identification and records. Any label claims that
ultimately are made will be handled through the usual FSIS label
approval process.
The pilot program began in August 2000 with the training of
qualified accredited veterinarians and enrollment of pork producers.
After the pilot is completed (in approximately one and a half years),
the Certification program will be made available nationally to all pork
producers and processors.
Finally, FSIS is also proposing to remove other referential and
related provisions concerning required treatment to eliminate trichina.
The Agency is proposing to remove all of the following additional
provisions: A reference to the required trichina treatment in
Sec. 303.1(f); the requirement under Sec. 319.106(b) that country ham
products and dry cured pork shoulder be treated for the destruction of
possible trichina; the requirement under Sec. 319.145(a)(2) that when
pork muscle tissue is combined with beef or veal, or both, in the
preparation of certain Italian sausage products, it be treated for the
destruction of possible live trichina; the record retention requirement
under Sec. 320.1(b)(7) concerning sample results and calculation
results as required by processing procedures to destroy trichina in
Sec. 318.10(c)(3)(iv) (Methods 5 and 6); the provision in Sec. 325.7(a)
for including pork that has been refrigerated to destroy trichina in
the category of products that require special supervision between
official establishments under official seal; and the provision under
Sec. 331.5(a)(1)(ii) that any meat or meat food product is adulterated
if it is a RTE pork product that has not been treated to destroy
trichina as prescribed in Sec. 318.10.
[[Page 12609]]
VIII. Other Proposed Revisions to the Regulations
FSIS is proposing that the labeling of RTE products state that the
product requires refrigeration after opening, as applicable. Current
regulations require that labels of perishable products include such
instructions, but the Agency is proposing to expand the required label
instructions to include RTE shelf-stable products that require
refrigeration after opening.
Also, FSIS is proposing to remove the regulations under
Sec. 318.17, 318.23, and 381.150 that require establishments not
operating under HACCP to develop process schedules for the production
of roast beef, cooked beef, corned beef; fully-cooked, partially-
cooked, and char-marked uncured meat patties; and fully-cooked and
partially-cooked poultry products, respectively. Similarly, FSIS is
proposing to remove the definitions for ``process schedule'' and
``process authority'' in Parts 301 and 381.1. These regulations were
established by the January 1999 rulemaking that also established the
pathogen reduction performance standards for these products. At that
time, certain official meat and poultry establishments were not yet
required to develop and implement HACCP systems. Therefore, with these
process schedule requirements, FSIS intended to ensure that all
establishments that developed customized processing systems to meet the
performance standards also would develop a validated system of process
control, similar to HACCP. As of January 25, 2000, all official
establishments are required to develop and implement HACCP systems, so
these process schedule requirements are no longer necessary.
IX. Scientific Information and Data Needs
FSIS has identified additional needs for scientific information and
analytical data that if addressed could strengthen the scientific
foundation of the rule. It is extremely important that the regulations
be based on sound science and common sense measures that involve
significant public comment. FSIS requests the specific information
identified in this document. In the section, the major data needs are
summarized.
In order to facilitate public input and gather additional
information during the comment period for this proposed rulemaking,
FSIS plans to hold public meetings and scientific conferences to
discuss the proposed provisions, especially those that would require
certain establishments to conduct environmental testing for Listeria
spp. FSIS also intends to present the proposed testing requirements and
related scientific issues to the NACMCF for review.
Testing for Listeria spp.
In their recent draft risk assessment regarding L. monocytogenes,
FDA and FSIS noted that there is an opportunity for recontamination of
RTE foods by the pathogen during processing in the plant, after the
lethality treatment is applied and before packaging (Ref. 28).
Consequently, under the proposed regulations, each establishment that
produces RTE meat and poultry products will be required to test food
contact surfaces for Listeria spp. where product is handled after
lethality but before final packaging, unless it has established a CCP
for L. monocytogenes in its HACCP plan(s). The establishment and FSIS
will use the test results to verify the efficacy of the establishment's
Sanitation SOPs in preventing RTE product contamination by L.
monocytogenes. If an establishment finds Listeria spp. on a food
contact surface, it must take the corrective action(s) defined in its
Sanitation SOPs, including: procedures to determine which lot or lots
of product might have been affected; procedures to hold, sample, and
test that product for L. monocytogenes; and procedures to dispose of
affected product.
FSIS is confident that testing of food contact surfaces to verify
that an establishment's Sanitation SOPs are eliminating Listeria spp.
from food contact surfaces will result in sanitation improvements that
will lead to reductions in the contamination of RTE meat and poultry
products by L. monocytogenes. FSIS also is aware that its current
testing of approximately 7,000 RTE product samples per year for L.
monocytogenes is an indicator of possible public health problems, but
that more discriminating approaches are in need of development.
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. monocytogenes, but has assumed 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 so as 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 may adjust this assumption, suggest specific
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 request data
regarding the relationship between Listeria spp. and L. monocytogenes
and how that relationship should affect any required testing
provisions; 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.
Considering the number of listeriosis cases and deaths probably
attributable to the consumption of adulterated RTE meat and poultry
products (see Appendix 1 for further discussion), FSIS believes the
public health benefits that would result from mandatory environmental
testing could easily exceed the costs of the testing. But, 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 pathogens
Salmonella and E. coli O157:H7 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
[[Page 12610]]
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 is available for deriving
hypothetical worst case products and corresponding performance
standards. 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.
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.
X. Summary of the Proposed Rule
In summary, FSIS is proposing the following requirements governing
the production of all RTE and partially heat-treated meat and poultry
products:
All RTE meat and poultry products, except for thermally-
processed, commercially sterile products, must be processed to achieve
a lethality performance standard that indicates a specific reduction in
Salmonella.
All fermented RTE meat and poultry products that contain
any amount of beef, except for thermally-processed, commercially
sterile products, must be processed to achieve an additional lethality
performance standard that indicates a specific reduction in E. coli
O157:H7.
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.
The processing of RTE meat and poultry products must be
validated to achieve the reduction of other pathogens and their toxins
or toxic metabolites necessary to prevent product adulteration.
Further, processing must be validated to maintain the lethality and
stabilization performance standards throughout product shelf-life under
the conditions in which the food is stored, distributed, and held.
All thermally-processed, commercially sterile meat and
poultry products must be processed to either eliminate or control the
growth of C. botulinum, depending on the pH of the product or other
factors that affect the growth of that pathogen. These products also
must be commercially sterile and the container in which the product is
enclosed must be hermetically sealed.
Each establishment that produces RTE meat and poultry
products must test food contact surfaces for Listeria spp. in order to
verify the efficacy of its Sanitation SOP, unless it has incorporated
one or more controls for L. monocytogenes into its HACCP plan. Testing
frequency will be based on establishment size. Food contact surface
positives for Listeria spp. will trigger mandatory product testing.
The regulations in Sec. 318.10 that require the
elimination of trichina from pork products will be rescinded.
XI. Compliance With Executive Order 12866
This proposed action has been reviewed for compliance with
Executive Order 12866. Because this proposed action has been determined
to be economically significant for purposes of Executive Order 12866,
the Office of Management and Budget has reviewed it.
FSIS is proposing to amend the Federal meat and poultry inspection
regulations by establishing pathogen reduction performance standards
for all RTE and all partially heat-treated meat and poultry products.
FSIS also is proposing to require establishments that produce RTE meat
and poultry products to conduct environmental testing for Listeria spp.
to verify that they are controlling L. monocytogenes within their
processing environments. Establishments that have developed and
implemented HACCP controls for L. monocytogenes would be exempt from
these testing requirements. Finally, FSIS is proposing to eliminate its
regulations that require that both RTE and not-ready-to eat pork and
products containing pork be treated to destroy trichina; these
requirements are inconsistent with HACCP and some will be unnecessary
if FSIS makes final the proposed performance standards for RTE meat and
poultry products.
This proposed action is compelled by recent outbreaks of foodborne
illness related to the consumption of adulterated RTE meat and poultry
products, as well as the need to provide objective, measurable pathogen
reduction standards that can be met by official establishments and
compliance with which can be established through Agency inspection.
Although FSIS routinely samples and tests some RTE products for the
presence of pathogens prior to distribution, there are no specific
regulatory pathogen reduction requirements for most of these products.
And in regard to thermally processed, commercially sterile (most often
canned) meat and poultry products, the proposed standards represent
regulatory reform; they replace lengthy, prescriptive regulations with
performance standards that provide the
[[Page 12611]]
same level of food safety, as well as increased flexibility for
establishments to customize their processes under HACCP.
Appendix 1, published in this issue of the Federal Register
immediately following this proposed rule, contains a preliminary
analysis required under Executive Order 12866, including a discussion
of the need for the proposed regulations, regulatory alternatives
considered by FSIS, and a complete cost-benefit analysis. FSIS
demonstrates in Appendix 1 why it believes that this proposed action
would result in benefits.
In short, if the proposed regulations could achieve a complete
elimination of listeriosis that results from the consumption of
contaminated RTE meat and poultry products, the expected annual
reduction in listeriosis cases and deaths would range from 1660 cases
and 331 deaths (based the draft FDA-FSIS risk assessment and on 100
percent program effectiveness) to 167 cases and 35 deaths (based on two
independent CDC studies and 100 percent program effectiveness). FSIS is
uncertain about the effectiveness of its proposed testing requirements
in reducing listeriosis and therefore unable to adequately quantify a
range of benefits. FSIS intends to use comments and data received
during the comment period and at the planned technical conference to
refine the proposed regulations and to better estimate benefits. It is
of course unlikely that the proposed regulations could achieve complete
elimination of the listeriosis that results from contaminated meat and
poultry, but FSIS believes that the benefits of the regulations would
exceed the total costs of all of the proposed provisions.
The two main provisions of the proposed rule are: (1) Mandatory in-
plant testing for Listeria and (2) Salmonella and E. coli O157:H7
performance standards firms must employ as measures of process control.
Much of costs of these actions are associated with first-year, one-time
validation pertaining to the achievement of the performance standards
and with the incorporation of new information into plants' HACCP plans.
These initial costs are projected at over $6.5 million, while annual
recurring costs are estimated at $6.2 million. Benefits are expected to
result from less contaminated product entering commercial channels due
to increased sanitation efforts and in-plant verification through
testing.
XII. Compliance With Regulatory Flexibility Act of 1996
The Administrator has determined that for the purposes of the
Regulatory Flexibility Act (5 U.S.C. 601-612), this proposed rule will
have a significant economic impact on a substantial number of small
entities. As discussed in the regulatory impact analysis, FSIS
estimates that the proposed performance standards may cost small and
very small producers of jerky, hotdogs, luncheon meat and meat patties
approximately $5 million annually, about 71 percent of the total costs
of compliance associated with these provisions.
FSIS considered not proposing to extend the performance standards
to these products because of the possible disproportionate economic
impact on small business. However, taking this alternative would result
in a significant inconsistency in the Agency's public health policy.
Most, if not all, RTE meat and poultry products are manufactured from
the same supply of raw product examined in the FSIS national baseline
surveys. So performance standards derived from this baseline should be
applicable to all categories of RTE meat and poultry products,
regardless of how they are processed. That is, all RTE products should
be required to meet the same standard of safety.
The ``Small Business Regulatory Enforcement Fairness Act of 1996''
(P. L. 104-121) requires, among other things, that
For each rule or group of related rules for which an agency is
required to prepare a final regulatory flexibility analysis under
section 604 of title 5, United States Code, the agency shall publish
one or more guides to assist small entities in complying with the
rule, and shall designate such publications as ``small entity
compliance guides''. The guides shall explain the actions a small
entity is required to take to comply with a rule or group of rules.
The agency shall, in its sole discretion, taking into account the
subject matter of the rule and the language of relevant statutes,
ensure that the guide is written using sufficiently plain language
likely to be understood by affected small entities. Agencies may
prepare separate guides covering groups or classes of similarly
affected small entities, and may cooperate with associations of
small entities to develop and distribute such guides.
With any final action that stems from this proposed rulemaking,
FSIS will publish compliance guides for small businesses. The guides
will include detailed instructions on how to comply with the proposed
performance standards for all categories of RTE meat and poultry
products. Establishments that wish to use the guides may incorporate
them into their HACCP plans. Because FSIS will base its guidance on
existing research and industry practices known to be effective, the
Agency also will consider the processing instructions to be already
validated. That is, establishment may follow the guidance without
contracting for or conducting additional validation. FSIS believes
compliance guides would significantly reduce the economic burden the
proposed regulations could place on small businesses.
FSIS is examining other options to minimize the potential negative
economic effects of these proposed regulations on small businesses,
including staggering the effective dates for any final regulations, in
consideration of establishment size. FSIS requests comment on other
measures it could take to mitigate the economic impact of any final
regulations.
FSIS also estimates that the direct cost of the mandatory
environmental testing provision of the proposed rule will entirely fall
on small and very small producers. Based on the preliminary analysis in
Appendix 1, FSIS expects that they will incur approximately $1.75
million annually (See Appendix 1 for details on the cost estimates).
Types of Entities and Production Affected by the Proposed Regulations
The 1997 Census of Manufacturers identifies 1630 establishments
which could potentially be affected by the proposed rule. In Appendix 1
and for this analysis, these establishments are broken down into four
broad groups that FSIS differentiated by the estimated costs of
compliance with all of the proposed provisions. These groups are
further broken down into sub-groups where appropriate. The main product
groups (and sub-groups, if appropriate) are:
Group I: Those entities that likely will incur the
greatest costs and which are further broken down into: Sub-group 1:
fermented, dried, and salt-cured RTE meat and poultry products; Sub-
group 2: hotdogs and wieners; Sub-group 3: cooked meat and poultry
patties; and, Sub-group 4: smoked hams and poultry luncheon meats;
Group II: Those entities that likely will incur moderate
costs and which are further broken down into three types of producers
of cooked or otherwise processed meat and poultry products (either
produced by a combo plant, meat or poultry processor);
Group III: those entities that likely will incur minor
costs (frozen dinners, pizza, and other similar meat and poultry
products); and
[[Page 12612]]
Group IV: those entities that likely will incur no costs
(canned meat and poultry products).
Almost 60 percent of all the establishments that could be
potentially affected by the proposed rule are classified as small
(employing between 10 and 500 employees) (Table 3). Another 32 percent
fall into the very small establishment category of employing fewer than
10 employees while the remaining 9 percent are classified as large
(employing more than 500 employees).
The number of establishments, the types of products shipped, and
value of shipments of these groups are summarized below in Table 3.
Most product groups and sub-groups exhibit a population
distribution in which about 33% of firms are very small, 60% are small,
and less than 10% are large. However, three product groups differ
markedly: Group II, Sub-groups 2 and 3 and Group IV (rows 11, 12, and
15 in Table 3). Large establishments play an important role in Group
II, Sub-group 2 (poultry processors of miscellaneous RTE products
containing meat and poultry) making up 37 percent of all their numbers.
As a consequence, the percentage contributions to their total numbers
for both small and very small establishments are much lower than the
all-group averages. Canners (Group IV) also exhibit a much different
population distribution than the average: they are dominated by small
establishments, which lowers the presence of very small canning
establishments. Finally, the percentage of very small combination
slaughter/meat processing establishments in Group II, Sub-group 3 have
almost as high a percentage of establishments as do the small
establishments for all groups (55 percent of this sub-group consists of
very small establishments while the percentage of small establishments
drop to 48 percent).
Table 3.--Number of Establishments by Size Which May Be Affected by RTE Rule and Their Proportion in Each
Product Group
----------------------------------------------------------------------------------------------------------------
Establishment size categories
Group and subgroup ---------------------------------------------------------------- Total
VS S VS+ S L
----------------------------------------------------------------------------------------------------------------
I:
1........................... 57 (38%) 85 (57%) 142 (95%) 8 (5%) 150
2........................... 56 (34%) 94 (56%) 150 (90%) 17 (10%) 167
3........................... 27 (36%) 47 (62%) 74 (98%) 2 (2%) 76
4........................... 64 (34%) 105 (55%) 169 (89%) 22(11%) 191
-------------------------------------------------------------------------------
Sub-Total............. 204 (35%) 331 (57%) 535 (92%) 49 (8%) 584
II:
1........................... 200 (36%) 339 (62%) 539 (98%) 12 (2%) 551
2........................... 25 (15%) 79 (48%) 104 (63%) 60 (37%) 164
3........................... 42 (55%) 29 (38%) 71 (93%) 5 (7%) 76
-------------------------------------------------------------------------------
Sub-Total............. 267 (34%) 447 (56%) 714 (90%) 77 (10%) 791
III............................. 35 (34%) 62 (59%) 97 (93%) 7 (7%) 104
IV.............................. 18 (12%) 121 (80%) 139 (92%) 12 (8%) 151
-------------------------------------------------------------------------------
Total................. 524 (32%) 961 (59%) 1485 (91%) 145 (9%) 1630
----------------------------------------------------------------------------------------------------------------
Note: VS stands for ``very small,'' S stands for ``small,'' and L stands for ``large.''
Totals may not add due to rounding.
First-Year Total Direct Cost Impacts Across Establishment Size by
Product Group
The total first year economic impacts (as estimated in Appendix 1)
were broken down by product group and size. The percentages reported in
Table 4 represent the impact on each product group as a percentage of
the total industry-wide impact. The distribution of the economic
impacts is based on assumptions, explained in detail in Appendix 1,
concerning which groups of industry will be affected by the proposed
performance standards, which will be affected by the proposed Listeria
requirements, and of those affected by the Listeria requirements, which
will choose to test for Listeria spp. and which will choose to develop
CCPs for L. monocytogenes. Significantly, FSIS expects that large
establishments would opt to develop CCPs for L. monocytogenes, but that
many small and very small establishments will opt to test for Listeria
spp.
Table 4.--Potential First-Year Total Direct Cost Impacts Across Establishment Sizes
--------------------------------------------------------------------------------------------------------------------------------------------------------
Across all product-types \1\
---------------------------------------------------------------------------------------
Group and subgroup VS S L Total \2\
---------------------------------------------------------------------------------------
000's $ % 000's $ % 000's $ % 000's $ %
--------------------------------------------------------------------------------------------------------------------------------------------------------
I:
1........................................................... 942.5 7.4 3108.4 24.6 1847.4 14.6 5898.3 46.6
2........................................................... 89.6 0.7 313.7 2.5 189.2 1.5 592.5 4.7
3........................................................... 308.3 2.4 1235.7 9.8 399.2 3.2 1943.3 15.4
4........................................................... 114.1 0.9 386.3 3.1 412.5 3.3 912.9 7.2
---------------------------------------------------------------------------------------
Sub-Total Group I..................................... 1454.5 11.5 5044.1 39.8 2848.3 22.5 9347.0 73.8
[[Page 12613]]
II:
1........................................................... 307.5 2.4 1093.1 8.6 313.5 2.5 1714.2 13.5
2........................................................... 59.7 0.5 313.1 2.5 575.4 4.5 948.2 7.5
3........................................................... 64.3 0.5 99.2 0.8 70.4 0.6 234.0 1.8
---------------------------------------------------------------------------------------
Sub-Total Group II.................................... 431.6 3.4 1505.4 11.9 959.3 7.6 2896.3 22.9
III............................................................. 58.4 0.5 213.3 1.7 144.6 1.1 416.3 3.3
IV.............................................................. 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00
---------------------------------------------------------------------------------------
Total................................................. 1944.5 15.4 6762.8 53.4 3952.3 31.2 12659.6 100.00
--------------------------------------------------------------------------------------------------------------------------------------------------------
Note: VS stands for ``very small,'' S stands for ``small,'' and L stands for ``large.''
Totals may not add due to rounding.
Matching up Percent of Establishments With Their Share of First Year
Total Cost Impacts
The establishment data from Table 3 was broken down in a similar
way as Table 4 above. That is, they were broken down by very small,
small, and large size categories as a percent of the total number of
establishments. This establishment population distribution (as reported
in columns 3, 5, 7, and 9 in Table 5) was then combined with the
distribution of the first-year industry-wide direct cost impacts from
Table 4 (as reported in columns 4, 6, 8, and 10 in Table 5). In effect,
Table 5 pairs each product group's percent of total establishments with
its share of total first-year industry-wide economic impact. For
example, the bottom line in Table 5 reveals that very small
establishments comprise 32 percent of all RTE establishments and
absorbs 15.4 percent of total first-year industry-wide economic impact
(as was reported in Table 4).
Table 5 reveals that large establishments, on an establishment
basis, bear a disproportionate share of the total regulatory cost. That
is, they constitute less than 10 percent of the establishments and yet
absorb over 31.2 percent of the first year total direct cost impacts.
Most of these impacts are incurred by large Group I establishments,
mainly to satisfy the performance standard requirements of the proposed
rule.
Table 5.--Percent of Total Establishments and Their Share of First-Year Total Direct Cost Impacts
--------------------------------------------------------------------------------------------------------------------------------------------------------
The percent of total establishments and total impact by establishment size
-----------------------------------------------------------------------------------------------------------
Group and sub-group Very small Small Large All sizes
-----------------------------------------------------------------------------------------------------------
Establishments Impact Establishments Impact Establishments Impact Establishments Impact
--------------------------------------------------------------------------------------------------------------------------------------------------------
I:
1....................................... 4 7.4 5 24.6 1 14.6 10 46.6
2....................................... 3 0.7 6 2.5 1 1.5 10 4.7
3....................................... 2 2.4 3 9.8 0 3.2 5 15.4
4....................................... 4 0.9 6 3.1 1 3.3 11 7.2
-----------------------------------------------------------------------------------------------------------
Sub-Total Group I................. 13 11.5 20 39.8 3 22.5 36 73.8
II:
1....................................... 12 2.4 21 8.6 1 2.5 34 13.5
2....................................... 1 0.5 5 2.5 4 4.5 10 7.5
3....................................... 3 0.5 2 0.8 0 0.6 5 1.8
-----------------------------------------------------------------------------------------------------------
Sub-Total Group II................ 16 3.4 28 11.9 5 7.6 49 22.8
Sub-Total Group III............... 2 0.5 4 1.7 0 1.1 6 3.3
Sub-Total Group IV................ 1 0.0 7 0.0 1 0.0 9 0.0
-----------------------------------------------------------------------------------------------------------
Total......................... 32 15.4 59 53.4 9 31.2 100 100
--------------------------------------------------------------------------------------------------------------------------------------------------------
Totals may not add due to rounding.
Per-Establishment Impact Estimates
FSIS realizes that the proposed rule has a unique impact on each
establishment. Some establishments are already meeting the performance
standards and some probably not; some establishments are conducting
environmental tests for Listeria and have a Listeria-related CCP; some
do not. The following tables attempt to put the aggregate impact of the
proposed rule on an individual establishment basis. This sheds
additional light on the distributional impact across establishment
size. By so doing, a different picture on the relative impact on
different size establishments comes into view. Keep in mind that the
estimates below are made on an affected establishment basis, not on a
purely product group average basis.
[[Page 12614]]
Performance Standards
For the 28 very small, 44 small, and 3 large establishments in
Group I potentially affected by the proposed rule, performance
standards may necessitate that these establishments incur an additional
$40,210, $89,380 and $630,140 per firm in the first year for each size
establishment, respectively (Table 6).
Most of these expected expenditures reflect increased treatment
costs. These per firm costs, multiplied by the number of affected
firms, produce an industry-wide, first-year cost impact of
approximately $7.1 million (Table 6). The estimation of these costs is
further explained in Appendix 1 in the sections entitled ``A. Projected
Costs Associated with Production Adjustments'' and ``B. Projected Costs
Associated with Performance Standard Validation.'' FSIS acknowledges
that due to a lack of available data, the total costs of the proposed
performance standards may be underestimated. See the section in
Appendix 1 entitled ``Uncertainty: Cost Side'' for further discussion
of the uncertainty around these estimated costs.
Mandatory Testing Requirements:
Mandatory food contact surface testing is the most difficult
provision in the proposed rule to analyze because of the uncertainty of
current practices and how establishments will react to the proposed
rule. Major uncertainties include: the degree to which firms will
switch to a Listeria-related CCP in their HACCP plan and the degree to
which firms will be able to resolve their Listeria-related problems if
they present themselves. Depending on the individual establishment,
this provision of the proposed rule could necessitate small
establishments incurring an additional $5,000 (to establish a Listeria-
related CCP) or an additional $3,400 in environmental testing, and
possibly as high as a $6,200 cost to resolve any Listeria-related
problems. Large establishments are expected to meet this requirement by
either having or incorporating a CCP addressing Listeria in their HACCP
plan at a cost of $5000. Very small establishment could incur an
additional $5000 cost (in CCP validation) or an additional $840 in
environmental testing and possibly a $3200 cost in resolving their
Listeria-related problems. Nineteen large establishments are expected
to incur an $81,900 to implement measures to resolve their Listeria-
related problems.
Summary
In the aggregate, large establishments incur a disproportionate
share of the total industry-wide impact. This result is due to the
volume-based costs associated with performance standards. On an
individual establishment basis, the proposed rule still presents a
substantial potential cost increase for very small and small
establishments. Efforts to reduce validation costs on CCPs addressing
Listeria and performance standards could afford this group of
establishments with great financial relief. The treatment costs related
to the performance standards is also an important driver in this
analysis: this cost estimate is based on limited information at this
time. Also, the flexibility afforded producers by the proposed rule may
mean that new, more cost-effective, technology may be adopted in a
relatively short time period and lower these costs. Such assumptions
could not be incorporated in this analysis at this time.
Table 6.--Distributional Economic Cost of Performance Standards in Proposed Rule
--------------------------------------------------------------------------------------------------------------------------------------------------------
Per establishment cost impact Number of establishments affected (number) Industry-wide impacts (000's $)
(000's $ per establishment) ---------------------------------------------------------------------------------------
Group and sub-group ----------------------------------
VS S L All VS S L All VS S L Total
--------------------------------------------------------------------------------------------------------------------------------------------------------
I:
1......................... 45 100 650 108.4 19 28 3 50 854.15 2830.5 1731.6 5416.25
2......................... 0 0 0 0 0 0 0 0 0.00 0 0 0.00
3......................... 30 70 550 68.4 9 16 1 25 267.30 1085.7 363.0 1716.00
4......................... 0 0 0 0 0 0 0 0 0.00 0 0.00 0.00
-------------------------------------------------------------------------------------------------------------------------
SubTotal Group I.......... 40.2 89.4 630.1 95.1 28 44 3 75 1121.45 3916.2 2094.60 7132.25
II:
1......................... 0 0 0 0 0 0 0 0 0 0 0 0
2......................... 0 0 0 0 0 0 0 0 0 0 0 0
3......................... 0 0 0 0 0 0 0 0 0 0 0 0
III:.......................... 0 0 0 0 0 0 0 0 0 0 0 0
IV:........................... 0 0 0 0 0 0 0 0 0 0 0 0
-------------------------------------------------------------------------------------------------------------------------
Total............... 40.2 89.4 630.1 95.1 28 44 3 75 1121.45 3916.2 2094.6 7132.245
--------------------------------------------------------------------------------------------------------------------------------------------------------
Totals may not add due to rounding.
Table 7.--Distributional Economic Cost of Additional Testing Associated with Mandatory Listeria Testing Provision in Proposed Rule.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Per establishment cost impact Number of establishments affected (number) Industry-wide impacts (000's $)
(000's $ per establishment) ---------------------------------------------------------------------------------------
Group and sub-group ----------------------------------
VS S L All VS S L All VS S L Total
--------------------------------------------------------------------------------------------------------------------------------------------------------
I:
1......................... .84 3.4 0 2.1 46 43 0 88 38.3 142.8 0.0 181.1
2......................... .84 3.4 0 2.1 45 47 0 92 37.6 157.9 0.0 195.5
3......................... .84 3.4 0 2.1 22 23 0 45 18.1 79.0 0.0 97.1
4......................... .84 3.4 0 2.1 51 53 0 104 43.0 176.4 0.0 219.4
II:
1......................... .84 3.4 0 2.1 160 170 0 330 134.4 569.5 0.0 703.9
2......................... .84 3.4 0 2.5 20 40 0 60 16.8 132.7 0.0 149.5
3......................... .84 3.4 0 1.6 34 15 0 48 28.2 48.7 0.0 76.9
III........................... .84 3.4 0 2.2 28 31 0 59 23.5 104.2 0.0 127.7
[[Page 12615]]
IV............................ 0 0 0 0.0 0 0 0 0 0 0 0.0 0
-------------------------------------------------------------------------------------------------------------------------
Total............... .84 3.4 0 2.1 405 420 0 825 340.0 1411.2 0.0 1751.2
--------------------------------------------------------------------------------------------------------------------------------------------------------
Totals may not add due to rounding.
Table 8.--Distributional Economic Cost of HACCP Validation Associated With Listeria Monocytogenes Controls in Proposed Rule
--------------------------------------------------------------------------------------------------------------------------------------------------------
Per establishment cost impact Number of establishments affected (number) Industry-wide impacts (000's $)
(000's $ per establishment) ---------------------------------------------------------------------------------------
Group and sub-group ----------------------------------
VS S L All VS S L All VS S L Total
--------------------------------------------------------------------------------------------------------------------------------------------------------
I:
1......................... 5.0 5.0 5.0 5.0 6 14 4 24 28.5 70.8 20.00 119.3
2......................... 5.0 5.0 5.0 5.0 6 16 9 30 28.0 78.3 42.50 148.8
3......................... 5.0 5.0 5.0 5.0 3 8 1 12 13.5 39.2 5.00 57.67
4......................... 5.0 5.0 5.0 5.0 6 18 11 35 32.0 87.5 55.00 174.50
-------------------------------------------------------------------------------------------------------------------------
Sub-Total--Group I.. 5.0 5.0 5.0 5.0 20 55 25 100 102.0 275.8 122.50 500.30
II:
1......................... 5.0 5.0 5.0 5.0 20 57 6 83 100.0 282.5 30.0 412.5
2......................... 5.0 5.0 5.0 5.0 3 13 30 46 12.5 65.8 150.0 228.3
3......................... 5.0 5.0 5.0 5.0 4 5 3 12 21.0 24.2 12.5 57.7
-------------------------------------------------------------------------------------------------------------------------
Sub-Total--Group II. 5.0 5.0 5.0 5.0 27 75 39 14 133.5 372.5 192.5 698.5
III........................... 5.0 5.0 5.0 5.0 4 10 4 17 17.5 51.7 17.5 86.7
IV............................ 0 0 0 0 0 0 0 0 0 0 0 0
-------------------------------------------------------------------------------------------------------------------------
Total............... 5.0 5.0 5.0 5.0 51 140 67 257 253 700 332.5 1285.5
--------------------------------------------------------------------------------------------------------------------------------------------------------
Numbers may not add due to rounding.
Table 9.--Distributional Economic Cost of Production Effect 1 and 2 Associated With the Mandatory Listeria Testing Provisions in Proposed Rule
--------------------------------------------------------------------------------------------------------------------------------------------------------
Per establishment cost impact Number of establishments affected (number) Industry-wide impacts (000's $)
(000's $ per establishment) ---------------------------------------------------------------------------------------
Group and sub-group ----------------------------------
VS S L All VS S L All VS S L Total
--------------------------------------------------------------------------------------------------------------------------------------------------------
I:
1......................... 2.7 5.4 85.5 8.65 8 12 1 21 21.53 64.3 95.80 181.63
2......................... 3.0 5.9 61.6 10.6 2 13 2 23 23.96 77.5 146.71 248.17
3......................... 2.5 4.8 111.6 6.8 4 7 0 11 9.41 31.9 31.20 72.51
4......................... 4.4 8.3 116.1 19.4 9 15 3 27 39.1 122.4 357.50 519.00
-------------------------------------------------------------------------------------------------------------------------
Sub-Total--Group I........ 3.3 6.4 92.0 12.5 29 46 7 82 94 296.1 631.21 1021.31
II:
1......................... 2.6 5.1 168.8 7.7 28 47 2 77 73.1 241.1 283.5 597.7
2......................... 8.7 10.4 50.6 24.8 4 11 8 23 30.44 114.5 425.4 570.34
3......................... 2.6 6.5 82.7 9.3 6 4 1 11 15.1 26.3 57.9 99.3
-------------------------------------------------------------------------------------------------------------------------
Sub-Total--Group II....... 3.2 6.1 71.1 11.4 37 63 11 111 118.64 381.9 766.8 1267.34
III........................... 3.5 6.6 129.7 13.8 5 9 1 15 17.4 57.4 127.1 201.9
IV............................ 0 0 0 0 0 0 0 0 0 0 0 0
-------------------------------------------------------------------------------------------------------------------------
Total..................... 3.2 6.2 81.9 12.0 71 118 19 207 230.02 735.4 1525.20 2490.65
--------------------------------------------------------------------------------------------------------------------------------------------------------
Totals may not add due to rounding.
XIII. Executive Order 12988
This proposed rule has been reviewed under Executive Order 12988,
Civil Justice Reform. States and local jurisdictions are preempted by
the Federal Meat Inspection Act (FMIA) and the Poultry Products
Inspection Act (PPIA) from imposing any marking, labeling, packaging,
or ingredient requirements on federally inspected meat and poultry
products that are in addition to, or different than, those imposed
under the FMIA and PPIA. States and local jurisdictions may, however,
exercise concurrent jurisdiction over meat and poultry products that
are outside official establishments for the purpose of preventing the
distribution of meat and poultry products that are misbranded or
adulterated under the FMIA and PPIA, or, in the case of imported
articles, that are not at such an establishment, after their entry into
the United States. This proposed rule is not intended to have
retroactive effect.
[[Page 12616]]
If this proposed rule is adopted, administrative proceedings will
not be required before parties may file suit in court challenging this
rule. However, the administrative procedures specified in 9 CFR 306.5
and 381.35 must be exhausted prior to any judicial challenge of the
application of the provisions of this proposed rule, if the challenge
involves any decision of an FSIS employee relating to inspection
services provided under the FMIA or PPIA.
XIV. Risk Analysis
Section 304 of the Federal Crop Insurance Reform and Department of
Agriculture Reorganization Act of 1994 (P.L. 103-354) requires any
regulation published by USDA concerning human health, safety, or the
environment, and having an annual economic impact of at least $100
million in 1994 dollars, contain a risk assessment and cost-benefit
analysis. The risk assessment and cost-benefit analysis must be
``performed consistently and use reasonably obtainable and sound
scientific, technical, economic, and other data.'' The USDA Office of
Risk Assessment and Cost-Benefit Analysis (ORACBA), also established by
the 1994 Act, must ensure that major rules include such analyses.
Although the initial costs of compliance with the proposed
regulations may be less than $100 million, they also may exceed $100
million. FSIS estimates that over an undetermined, but relatively short
period of time, the benefits of the regulations also should exceed this
amount. In the economic analysis required under E. O. 12866, FSIS
estimates that after 10 years, 868 to 8,632 cases of listeriosis may be
eliminated as a result of this rule (see Appendix 1). Consequently,
FSIS believes that the proposed regulations are subject to the
Reorganization Act requirements for a risk assessment and cost-benefit
analysis.
FSIS and ORACBA have agreed that the cost-benefit and economic
impact analyses that FSIS has performed for this proposed rule, as
required by E.O. 12866 and the Regulatory Flexibility Act, satisfy the
cost-benefit analysis requirements of the Reorganization Act. Regarding
the required risk assessment, FSIS is presenting several different
documents to support different provisions of the proposed regulations.
To support the proposed lethality performance standard for the
elimination of E. coli O157:H7 from fermented RTE products that contain
beef, FSIS cites its draft ``Risk Assessment of the Public Impact of
Escherichia coli O157:H7 in Ground Beef'' (Ref. 1, available for
viewing by the public in the FSIS Docket Room). As discussed above,
this document shows that levels of E. coli O157:H7 in cattle represent
a risk to consumers of ground beef, and that, unless there is a
significant intervention on the farm or during processing, the risk is
likely to remain. Use of this draft risk assessment to develop the
performance standard for fermented products containing beef is
discussed above in detail in the sections ``Derivation of the Proposed
Lethality Performance Standards'' and ``Fermented Products.''
To support the other proposed lethality performance standards,
except for the lethality standards applicable to commercially sterile
meat and poultry products, and to support the proposed stabilization
performance standards, FSIS used its Nationwide Microbiological
Baseline Data Collection Programs and Nationwide Federal Plant
Microbiological Surveys (Ref. 3, available for viewing by the public in
the FSIS Docket Room), as well as its technical analysis of those
surveys (Ref. 2, available for viewing by the public in the FSIS Docket
Room). Within the technical analysis, FSIS developed models using the
baseline and survey data to define a worst case raw product (the
highest initial levels of Salmonella found in the data from the
microbiological surveys), and then calculate the probability
distribution for the number of surviving Salmonella organisms in 100
grams of finished product for various specific lethality reductions.
Lethality performance standards then were selected that provided low
probabilities of surviving organisms in finished worst case product.
Most, if not all, RTE meat and poultry products will be manufactured
from the same supply of raw product examined in the FSIS national
baseline surveys. So, using performance standards that would render any
hypothetical, worst case raw product safe should be applicable to all
categories of RTE meat and poultry products.
To support the proposed environmental testing requirements for
Listeria spp., FSIS uses the draft interagency risk assessment
concerning foodborne Listeria monocytogenes (Ref. 28, available for
viewing by the public in the FSIS Docket Room). As discussed above in
the section entitled ``Proposed Requirements for Controlling L.
monocytogenes,'' this draft risk assessment indicates that many of the
meat and poultry products affected by these regulations (deli meat,
frankfurters, meat and poultry-based deli salads, and pate) pose
relatively high risks to consumers because of potential recontamination
by L. monocytogenes after lethality is applied and before final product
packaging.
XV. Additional Public Notification
Public awareness of all segments of rulemaking and policy
development is important. FSIS provides a weekly FSIS Constituent
Update via fax to over 300 organizations and individuals. In addition,
the update is available on line through the FSIS web page located at
http://www.fsis.usda.gov. The update is used to provide information
regarding FSIS policies, procedures, regulations, Federal Register
notices, FSIS public meetings, recalls, and any other types of
information that could affect or would be of interest to our
constituents/stakeholders. The constituent fax list consists of
industry, trade, and farm groups, consumer interest groups, allied
health professionals, scientific professionals, and other individuals
that have requested to be included. Through these various channels,
FSIS is able to provide information to a much broader, more diverse
audience than would be otherwise possible. For more information or to
be added to the constituent fax list, fax your request to the
Congressional and Public Affairs Office, at (202) 720-5704.
XVI. Paperwork Requirements
Paperwork Requirements
In accordance with section 3507(d) of the Paperwork Reduction Act
of 1995, the information collection or recordkeeping requirements
included in this proposed rule have been submitted for approval to the
Office of Management and Budget (OMB).
Abstract: FSIS has reviewed the paperwork and recordkeeping
requirements in this proposed rule in accordance with the Paperwork
Reduction Act. Establishments producing RTE product would make
modifications to their HACCP plans. Also, establishments that produce
RTE product and who do not identify L. monocytogenes as a hazard
reasonably likely to occur, must perform tests for Listeria spp. to
verify that their Sanitation SOPs are preventing direct contamination
or adulteration of product. Establishments would need to maintain these
results. The proposed revisions to the labeling requirements in
Secs. 317.2 and 381.125 would effect generically approved labels and so
do not constitute a paperwork burden.
Estimate of Burden: FSIS estimates that 1,630 establishments will
produce paperwork and recordkeeping as a result
[[Page 12617]]
of this rulemaking. Because the Agency does not know how an
establishment will decide to implement certain requirements of this
rule, that is some may modify their HACCP plans and others may chose to
test product, FSIS used the total of 1,630 to make its burden estimates
for each paperwork and recordkeeping activity. The Agency estimates
that it will take 8 hours for an establishment to reassess their HACCP
plans for a total burden of 13,040 hours. The Agency estimates that an
establishment will spend about 5 minutes a day (250 days) completing 1
monitoring record for each new CCP for a total burden of 33,958 hours
and 2 minutes a day filing the resulting record for a total of 13,583
hours. FSIS assumes each establishment will develop one new CCP. For an
establishment testing products for Listeria spp., FSIS estimates it
will take an establishment 30 minutes a day to collect the information
and file the records for a total of 203,750 hours.
Respondents: Meat and poultry product establishments.
Estimated Number of Respondents: 1,630.
Estimated Number of Responses per Respondents: 502.
Estimated Number of Responses: 818,260.
Estimated Total Annual Burden on Respondents: 264,708.
Copies of this information collection assessment can be obtained
from Lee Puricelli, Paperwork Specialist, Food Safety and Inspection
Service, USDA, Room 109 Cotton Annex, Washington, DC 20250-3700.
Comments are invited on: (a) Whether the proposed collection of
information is necessary for the proper performance of the functions of
the Agency, including whether the information will have practical
utility; (b) the accuracy of the Agency's estimate of the burden of the
proposed collection of information including the validity of the method
and the assumptions used; (c) ways to enhance the quality, utility, and
clarity of the information to be collected; (d) ways to minimize the
burden of the collection of information on those who are to respond;
including through use of appropriate automated, electronic, mechanical,
or other technological collection techniques or other forms of
information technology. Comments may be sent to Lee Puricelli, see the
address above, and to the Desk Officer for Agriculture, Office of
Information and Regulatory Affairs, Office of Management and Budget
(OMB) Washington, DC 20253. A comment to OMB is best assured of having
its full effect if OMB receives is within 30 days of publication of
this proposed rule.
XVII. References
The following sources are referred to in this document. All have
been placed on display in the FSIS Docket Room (address above) and may
be seen by interested persons between 8:30 a.m. and 4:30 p.m., Monday
through Friday.
1. FSIS Office of Public Health and Science, ``Draft Risk Assessment
of the Public Health Impact of Escherichia coli O157:H7 in Ground
Beef, 2000.
2. Ahmed, N. M., D. E. Conner, and D.L. Huffman, ``Heat-resistance
of Escherichia coli O157:H7 in meat and poultry as affected by
product composition,'' Journal of Food Science, 60(3): 606-610,
1995.
3. FSIS, ``Lethality and Stabilization Performance Standards for
Certain Meat and Poultry Products: Technical Paper,'' 1998.
4. FSIS, Microbiological Baseline Data Collection Program reports
and Microbiological Surveys, 1994-1996.
5. American Gastroenterological Association, ``Consensus Conference
Statement: Escherichia coli O157:H7 Infections-An Emerging National
Health Crisis, July 11-13, 1994,'' Gastroenterology, 108(6):1923-
1934, 1995.
6. Wells, J. G., et al., ``Laboratory Investigation of Hemorrhagic
Colitis Outbreaks Associated with a Rare Escherichia coli
Serotype,'' Journal of Clinical Microbiology, 18:512-520, 1983.
7. Todd, E.C.D., et al., ``Rapid Hydrophobic Grid Membrane Filter-
Enzyme-Labeled Antibody Procedure for Identification and Enumeration
of Escherichia coli O157 in Foods,'' Applied Environmental
Microbiology, 54:2536-2540, 1988.
8. Harrison, J.A. and M. A. Harrison, ``Fate of Escherichia coli
O157:H7, Listeria monocytogenes, and Salmonella typhimurium during
preparation and storage of beef jerky,'' Journal of Food Protection,
59:1336-1338, 1996.
9. Harrison, J. A., M. A. Harrison, and R.A. Rose, ``Fate of
Listeria monocytogenes and Salmonella species in ground beef
jerky,'' Journal of Food Protection, 60:9:1139-1141, 1997.
10. Harrison, J. A., M. A. Harrison, and R.A. Rose, ``Survival of
Escherichia coli O157:H7 in ground beef jerky assessed on two
plating media Journal of Food Protection,'' 61:11:13., 1998.
11. CDC, Morbidity and Mortality Weekly Report, 44:785-788, 1995.
12. Keene, W.E., et al., ``An outbreak of Escherichia coli O157:H7
infections traced to jerky made from deer meat,'' Journal of the
American Medical Association, 277:15:1229-1231, 1997.
13. Tompkin, R. B., ``Microbiology of ready-to-eat meat and poultry
products,'' pp. 89-121, in Advances in Meat Research, volume 2, A.
M. Pearson and T.R. Dutson, eds., AVI Publishing Co., Westport, CT.,
1986.
14. Gonzalez-Helva, M.A., M.F. Gutierrez, and M.C. Mendoza,
``Diagnosis by a combination of typing methods of a Salmonella
typhimurium outbreak associated with cured ham,'' Journal of Food
Protection, 59:426-428, 1996.
15. Mete, R., R. R. Fichera, and P. Chierchini, ``Episodio di
tossinfezione alimentare da Salmonella C2 trasmessa da prosciutto,''
Nuovi Annali d'Igiene e Microbiologia, 38:219-224, 1987.
16. CDC, Morbidity and Mortality Weekly Report, 44(9):157-160, 1995.
17. FSIS Epidemiology and Emergency Response Program, ``Outbreak
Report: Salmonella in Lebanon Bologna,'' May 22, 1996.
18. Haymon, L.W., ``Fermented sausage,'' pp. 237-245, in Industrial
Microbiology, 4th Edition, Prescott and Dunn, eds., AVI Publishing
Co., Westport, CT., 1982.
19. Tatini, S. R., ``Influence of food environments on growth of
Staphylococcus aureus and production of enterotoxins,'' Journal of
Milk Food Technology, 36(11):559-563, 1973.
20. Smith, J.L., et al., ``Survival of Salmonella dublin and
Salmonella typhimurium in Lebanon bologna,'' Journal of Milk Food
Technology, 38(3):150-154, 1975.
21. Bacus, J., ``Processing procedures to control Salmonella and E.
coli in fermented sausage products,'' Food Australia, 49(11):543-7,
1997.
22. Ellajosyula, K.R., et al., ``Destruction of E. coli O157:H7 and
Salmonella typhimurium in Lebanon bologna by interaction of
fermentation pH, heating temperature and time,'' Journal of Food
Protection, 61(2):152-157, 1998.
23. Faith, N.G., et al., ``Viability of Escherichia coli O157:H7 in
pepperoni during the manufacture of sticks and the subsequent
storage of slices at 21, 4 and -20C under air vacuum and CO2,''
International Journal of Food Microbiology, 37:47-54, 1997.
24. Glass, K.A., et al., Applied Environmental Microbiology, Fate of
Esherichia coli O157:H7 as affected by pH or sodium chloride and in
fermented, dry sausage, 58(8):2513-2516, 1992.
25. Labbe, R., ``Clostridium perfringens,'' pp. 210 and 213, in Food
borne Bacterial Pathogens, M. Doyle (ed.), Marcel Dekker, Inc., New
York, 1989.
26. Hauschild, A., ``Criteria and Procedures for Implicating
Clostridium Perfringens in Food-borne Outbreaks,'' Canadian Journal
of Public Health, 66:388-392, 1975.
27. McClane, B.A., ``Clostridium Perfringens Enterotoxin: Structure,
Action, and Detection,'' Journal of Food Safety, 12:237-252, (1992).
28. Center for Food Safety and Applied Nutrition, FDA, and FSIS,
``Draft Risk Assessment of the Public Health Impact of Foodborne
Listeria monocytogenes,'' January 19, 2001.
29. Tompkin, R. Bruce, et al., ``Guidelines to Prevent Post-
Processing Contamination from Listeria Monocytogenes,'' Dairy, Food,
and Environmental Sanitation, 8:552, 1999.
30. Pflug, I.J., T.E. Odlaug, ``A review of z and F values used to
ensure the safety of low-acid canned food,'' Food Technology, 32:63-
70, 1978.
31. Pflug, I.J., ``Calculating FT values for heat
preservation of shelf-stable, low-acid
[[Page 12618]]
canned foods using the straight-line semilogarithmic model,''
Journal of Food Protection, 50:608-620, 1987.
32. Beumer, R. R., Mc C. te Giffel, E. de Boer, and F. M. Rombouts.
1996. Growth of Listeria monocytogenes on sliced cooked meat
products. Food Microbiology 13: 333-340.
33. Centers for Disease Control and Prevention. 1999. Update: Multi-
state outbreak of listeriosis--United States, 1998-1999. Morbidity
and Mortality Weekly Report 47(50): 1117-1118.
34. Anderson, G., Contra Costa County Health Department, San
Francisco Department of Public Health, L. Mascola, G. W. Rutherford,
M. S. Rados, R. Hutchenson, P. Archer, P. Zenker, C. Harvey, J. D.
Smith, and CDC. 1992. Update: Foodborne listeriosis--United States,
1988-90, pages 251, 257-258, Morbidity and Mortality Weekly Report.
35. Office of Inspector General, USDA. June 2000. FSIS
Implementation of HACCP, Report No. 24001-3-At.
XVIII. Proposed Regulations
List of Subjects
9 CFR Part 301
Meat inspection.
9 CFR Part 303
Meat inspection, Reporting and recordkeeping requirements.
9 CFR Part 317
Food labeling.
9 CFR Part 318
Meat inspection, Reporting and recordkeeping requirements.
9 CFR Part 319
Food grades and standards, Food labeling, Frozen foods, Meat
inspection, Oils and fats.
9 CFR Part 320
Meat inspection, Reporting and recordkeeping requirements.
9 CFR Part 325
Meat inspection, Reporting and recordkeeping requirements,
Transportation.
9 CFR Part 331
Intergovernmental regulations, Meat inspection.
9 CFR Part 381
Poultry and poultry products inspection, Reporting and
recordkeeping requirements.
9 CFR Part 417
Meat inspection, Poultry and poultry products inspection, Reporting
and recordkeeping requirements.
9 CFR Part 430
Food labeling, Meat inspection, Poultry and poultry products
inspection.
Accordingly, title 9, chapter III, of the Code of Federal
Regulations is amended as follows:
PART 301--DEFINITIONS
1. The authority citation for part 301 would continue to read as
follows:
Authority: 7 U.S.C. 450, 1901-1906; 21 U.S.C. 601-695; 7 CFR
2.18, 2.53.
2. Section 301.2 would be amended by removing the definitions for
``Process authority'' and ``Process schedule.''
PART 303--EXEMPTIONS
3. The authority citation for part 303 would continue to read as
follows:
Authority: 21 U.S.C. 601-695; 7 CFR 2.17, 2.55.
4. In Sec. 303.1(f), the second sentence would be removed.
PART 317--LABELING, MARKING DEVICES, AND CONTAINERS
5. The authority citation for part 317 would continue to read as
follows:
Authority: 21 U.S.C. 601-695; 7 CFR 2.18, 2.53.
6. In Sec. 317.2, paragraph (k) and the introductory text of
paragraph (l) would be revised to read as follows:
Sec. 317.2 Labels: definition; required features.
* * * * *
(k) Packaged products which require special handling to maintain
their wholesome condition must have prominently displayed on the
principal display panel the statement: ``Keep Refrigerated,'' ``Keep
Frozen,'' ``Perishable Keep Under Refrigeration,'' or ``Refrigerate
after Opening,'' as applicable, or such similar statement as the
Administrator may approve in specific cases. Products that are
distributed frozen during distribution shall bear the statement on the
shipping container: ``Keep Frozen.'' The consumer-size containers for
such products that are thawed prior to or during display for sale at
retail shall bear the statement ``Previously Handled Frozen for Your
Protection, Refreeze or Keep Refrigerated.'' For all perishable canned
products the statement shall be shown in upper case letters one-fourth
inch in height for containers having a net weight of 3 pounds or less,
and for containers having a net weight over 3 pounds, the statement
shall be in upper case letters at least one-half inch in height.
(l) Safe handling instructions shall be provided for: All meat and
meat products of cattle, swine, sheep, goat, horse, or other equine
that do not meet the requirements contained in 9 CFR 430.2 and
430.3(a), except as exempted under paragraph (l)(4) of this section.
* * * * *
PART 318--ENTRY INTO OFFICIAL ESTABLISHMENTS; REINSPECTION AND
PREPARATION OF PRODUCT
7. The authority citation for part 318 would continue to read as
follows:
Authority: 7 U.S.C. 138f, 7 U.S.C. 450, 1901-1906; 21 U.S.C.
601-695; 7 CFR 2.18, 2.53.
8. Section 318.10 would be removed and reserved.
9. Section 318.17 would be removed and reserved.
10. Section 318.23 would be removed and reserved.
11. Subpart G (Secs. 318.300 through 318.311) would be removed.
PART 319--DEFINITIONS AND STANDARDS OF IDENTITY OR COMPOSITION
12. The authority citation for part 319 would continue to read as
follows:
Authority: 7 U.S.C. 450, 1901-1906; 21 U.S.C. 601-695; 7 CFR
2.17, 2.55.
13. In Sec. 319.106, paragraph (b) would be removed; paragraph (c)
would be redesignated as paragraph (b); and paragraph (d) would be
redesignated as paragraph (c).
14. In Sec. 319.145, paragraph (a)(2) would be amended by removing
the third sentence.
PART 320--RECORDS, REGISTRATION, AND REPORTS
15. The authority citation for part 320 would continue to read as
follows:
Authority: 21 U.S.C. 601-695; 7 CFR 2.18, 2.53.
16. In Sec. 320.1, paragraph (b)(6) and (b)(7) would be removed;
paragraph (b)(8) would be redesignated as (b)(6); paragraph (b)(9)
would be redesignated as (b)(7); paragraph (b)(10) would be
redesignated as (b)(8); and paragraph (b)(11) would be redesignated as
(b)(9).
PART 325--TRANSPORTATION
17. The authority citation for part 325 would continue to read as
follows:
Authority: 7 U.S.C. 450, 1901-1906; 21 U.S.C. 601-695; 7 CFR
2.17, 2.55.
18. In Sec. 325.7, paragraph (a) would be amended by removing the
phrase, ``pork that has been refrigerated to destroy trichina,''.
[[Page 12619]]
PART 331--SPECIAL PROVISIONS FOR DESIGNATED STATES AND TERRITORIES;
AND FOR DESIGNATION OF ESTABLISHMENTS WHICH ENDANGER PUBLIC HEALTH
AND FOR SUCH DESIGNATED ESTABLISHMENTS
19. The authority citation for part 331 would continue to read as
follows:
Authority: 21 U.S.C. 601-695; 7 CFR 2.17, 2.55.
20. In Sec. 331.5, paragraph (a)(1)(ii) would be amended to remove
the phrase, ``or it is a ready-to-eat pork product which has not been
treated to destroy trichinae as prescribed in Sec. 318.10 of this
subchapter for products at federally inspected establishments); or''.
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS
21. The authority citation for part 381 would continue to read as
follows:
Authority: 7 U.S.C. 138f, 450; 21 U.S.C. 451-470; 7 CFR 2.18,
2.53.
22. Section 381.1 would be amended by removing the definitions for
``Process authority'' and ``Process schedule.''
23. In Sec. 381.125, paragraph (a) would be revised to read as
follows:
Sec. 381.125 Special handling label requirements.
(a) Packaged products which require special handling to maintain
their wholesome condition must have prominently displayed on the
principal display panel the statement: ``Keep Refrigerated,'' ``Keep
Frozen,'' ``Perishable Keep Under Refrigeration,'' or ``Refrigerate
after Opening,'' as applicable, or such similar statement as the
Administrator may approve in specific cases. Products that are
distributed frozen during distribution shall bear the statement on the
shipping container: ``Keep Frozen.'' The consumer-size containers for
such products that are thawed prior to or during display for sale at
retail shall bear the statement ``Previously Handled Frozen for Your
Protection, Refreeze or Keep Refrigerated.'' For all perishable canned
products the statement shall be shown in upper case letters one-fourth
inch in height for containers having a net weight of 3 pounds or less,
and for containers having a net weight over 3 pounds, the statement
shall be in upper case letters at least one-half inch in height.
* * * * *
24.-25. In Sec. 381.125, the introductory text of paragraph (b)
would be amended by removing the phrase ``Sec. 381.150(a) or that have
not undergone other processing that would render them ready-to-eat''
and by adding the phrase ``9 CFR 430.2 and 430.3(a)'' in its place.
26. Section 381.150 would be removed.
27. In Sec. 381.175, paragraph (b)(3) would be removed; paragraph
(b)(4) would be redesignated as (b)(3); paragraph (b)(5) would be
redesignated as (b)(4); and paragraph (b)(6) would be redesignated as
(b)(5).
28. Subpart X (Secs. 381.300 through 381.311) would be removed and
reserved.
PART 417--HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP)
SYSTEMS
29. The authority citation for Part 417 would continue to read as
follows:
Authority: 7 U.S.C. 450; 21 U.S.C. 451-470, 601-695; 7 U.S.C.
1901-1906; 7 CFR 2.18, 2.53.
Sec. 417.2 Hazard Analysis and HACCP plan.
30. Paragraph 417.2(b)(3) would be removed.
PART 430--PERFORMANCE STANDARDS
31. A new Part 430 would be established to read as follows:
PART 430--PERFORMANCE STANDARDS FOR READY-TO-EAT AND PARTIALLY
HEAT-TREATED PRODUCTS
Sec.
430.1 Definitions.
430.2 Lethality.
430.3 Stabilization.
430.4 Testing for Listeria spp.
430.5 Thermally-processed, commercially sterile products.
Authority: 7 U.S.C. 450; 21 U.S.C. 451-470, 601-695; 7 U.S.C.
1901-1906; 7 CFR 2.18, 2.53.
Sec. 430.1 Definitions.
Acidified product. A commercially sterile and hermetically sealed
product that has been formulated or treated so that every component has
a pH value of 4.6 or lower within 24 hours after completion of the
thermal process unless a longer time has been validated as safe.
Commercial sterility. The condition achieved by the application of
a heat, irradiation, high-pressure, or other process, alone or in
combination with other ingredients or treatments, to render the product
free of microorganisms capable of growing in the product at
nonrefrigerated conditions (over 50 deg.F or 10 deg.C) at which the
product is intended to be held during distribution and storage.
Fermented product. A meat or poultry product that is made ready-to-
eat by the process in which bacterial enzymes act on organic
substrates, such as carbohydrates, resulting in the production of acid
(the lowering of product pH) and microbial inhibition.
Low acid product. A commercially sterile and hermetically sealed
product in which any component has a pH value above 4.6.
Ready-to-eat product. A meat or poultry product that can be safely
consumed without cooking or application of some other lethality
treatment to destroy pathogens.
Worst case product. For purposes of the lethality requirements
contained in Sec. 430.2(a)(1), worst case raw poultry contains 6.7-
log10 of Salmonella in any 143 gram sample and worst case
raw meat contains 6.2-log10 of Salmonella in any 143 gram
sample; for purposes of the lethality requirements contained in
Sec. 430.2(b)(1), worst case raw beef contains 4.4-log10 of
E. coli O157:H7 in any 143 gram sample.
Sec. 430.2 Lethality.
(a) (1) Processing of any meat or poultry product, except a
thermally-processed, commercially sterile product, for the purpose of
rendering that product ready-to-eat, must be validated to achieve
probabilities no greater than the following that Salmonella organisms
would remain in any 100 gram sample of finished product, assuming that
incoming raw product is worse case product. Any detectable level of
viable Salmonella organisms adulterates ready-to-eat meat and poultry
products.
------------------------------------------------------------------------
>0 surviving >1 surviving >2 surviving >3 surviving >4 surviving
------------------------------------------------------------------------
39.4% 9.06% 1.45% 0.177% 0.0174%
------------------------------------------------------------------------
(2) Official establishments that do not wish to demonstrate that
their processing results in probabilities no greater than the
probabilities in paragraph (a)(1) of this section may instead employ
processing validated to
[[Page 12620]]
achieve either a 6.5-log10 reduction of Salmonella
throughout a finished, ready-to-eat meat product, or, a 7-
log10 reduction of Salmonella throughout a finished ready-
to-eat product that contains any amount of poultry. Any detectable
level of viable Salmonella organisms adulterates ready-to-eat meat and
poultry products.
(b)(1) In addition to meeting the standard in paragraph (a), of
this section processing of any fermented meat or poultry product that
contains any amount of beef, except a thermally-processed, commercially
sterile product, for the purpose of rendering that product ready-to-
eat, must be validated to achieve probabilities no greater than the
following that E. coli O157:H7 organisms would remain in any 100 gram
sample of finished product, assuming that incoming raw product is worst
case product. Any detectable level of viable E. coli O157:H7 organisms
adulterates ready-to-eat meat and poultry products.
------------------------------------------------------------------------
>0 surviving >1 surviving
-------------------------------------------
22.2% 2.67%
------------------------------------------------------------------------
(2) Official establishments that do not wish to demonstrate that
their processing results in probabilities no greater than the
probabilities in paragraph (b)(1) of this section may instead employ
processing validated to achieve a 5-log10 reduction of E.
coli O157:H7 throughout a finished, ready-to-eat meat or poultry
product that contains any amount of beef. Any detectable level of
viable E. coli O157:H7 organisms adulterates ready-to-eat meat and
poultry products.
(c) Processing of all ready-to-eat meat and poultry products, other
than thermally processed, commercially sterile products, also must be
validated to achieve the reduction of other pathogens and their toxins
or toxic metabolites necessary to prevent product adulteration.
(d) Processing of all ready-to-eat products, other than thermally
processed, commercially sterile products, must be validated to maintain
the lethality performance standards throughout product shelf-life under
the conditions in which the food is stored, distributed, and held.
Sec. 430.3 Stabilization.
(a) For all ready-to-eat meat and poultry products, other than
thermally processed, commercially sterile products, processing must
prevent multiplication of toxigenic microorganisms such as Clostridium
botulinum and allow no more than 1-log10 multiplication of
Clostridium perfringens within the product.
(b) For all meat and poultry products that receive a heat treatment
but that are not ready-to-eat, processing must prevent multiplication
of toxigenic microorganisms such as C. botulinum and allow no more than
1-log10 multiplication of C. perfringens within the product.
(c) Processing of all ready-to-eat products, other than thermally
processed, commercially sterile products, and products that are heat-
treated but not ready-to-eat, must be validated to maintain the
stabilization performance standards throughout product shelf-life under
the conditions in which the food is stored, distributed, and held.
Sec. 430.4 Testing for Listeria spp.
(a) Each official establishment that produces one or more ready-to-
eat meat or poultry products, but that has not identified Listeria
monocytogenes as a hazard reasonably likely to occur within the HACCP
plan for its ready-to-eat product and consequently established one or
more controls for L. monocytogenes to be implemented after lethality
treatment is complete, must test food contact surfaces, on which
product is handled after lethality treatment but before final
packaging, for Listeria spp. at one of the following frequencies
depending on establishment size:
(1) If the plant is large (500 or more employees), at least four
tests, per line of ready-to-eat product, per month;
(2) If the plant is small (10 to 499 employees), at least two
tests, per line of ready-to-eat product, per month;
(3) If the plant is very small (fewer than 10 employees or annual
sales of ready-to-eat products less than $2.5 million), at least one
test, per line of ready-to-eat product, per month.
(b) Results of the testing required in this section are to be used
by official establishments to verify that their Sanitation Standard
Operating Procedures (Sanitation SOPs), as required under 9 CFR part
416, are preventing direct contamination or adulteration of product.
Results must be made available to FSIS personnel for review. In the
event of a positive test result, establishments must take corrective
actions under 9 CFR 416.15(a) and (b) that include the following
procedures to determine and demonstrate that the affected lot or lots
of product are not adulterated with L. monocytogenes:
(1) Procedures to determine which lot or lots of product might have
been affected;
(2) Procedures to hold, sample, and test that product for L.
monocytogenes; and
(3) Procedures to dispose of affected product.
Sec. 430.5 Thermally processed, commercially sterile products.
(a) For a low-acid product that receives thermal or other
sporicidal lethality processing, that processing must be validated to
achieve a probability of 10-\9\ that there are spores of C.
botulinum in a container of the product that are capable of growing,
or, a 12-log10 reduction of C. botulinum, assuming an
initial load of 1000 spores per container.
(b) For acidified products or products in which pathogen growth is
controlled by factors other than thermal or other sporicidal
processing, the processing must be validated to prevent multiplication
of C. botulinum in the food under the conditions in which the food is
stored, distributed, and held.
(c) The product must be processed to achieve commercial sterility
and the container in which the product is enclosed must be hermetically
sealed so as to be airtight and to protect the contents of the
container against the entry of microorganisms during and after
processing.
(d) All operators of processing systems for commercially sterile
meat and poultry products and container closure technicians shall be
under the direct supervision of a person who has successfully completed
a school of instruction that is generally recognized as adequate for
training supervisors of canning operations.
Done in Washington, DC on February 16, 2001.
Thomas J. Billy,
Administrator.
The following is an appendix to the preamble of the Proposed Rule.
Note: The following appendix will not appear in the Code of
Federal Regulations.
Appendix 1
Executive Order 12866--Preliminary Analysis
This proposed action has been reviewed for compliance with
Executive Order 12866. Because this proposed action has been
determined to be economically significant for purposes of Executive
Order 12866, the Office of Management and Budget has reviewed it.
Proposed Action
FSIS is proposing to amend the Federal meat and poultry
inspection regulations by establishing pathogen reduction
performance standards for all ready-to-eat (RTE) and all partially
heat-treated meat and poultry
[[Page 12621]]
products. FSIS also is proposing to require establishments that
produce RTE meat and poultry products to conduct food contact
surface testing for Listeria spp. to verify that they are
controlling Listeria monocytogenes within their processing
environments. Establishments that have developed and implemented
HACCP controls for L. monocytogenes would be exempt from these
testing requirements. Finally, FSIS is proposing to eliminate its
regulations that require that both RTE and not-ready-to eat pork and
products containing pork be treated to destroy trichina; these
requirements are inconsistent with HACCP and some will be
unnecessary if FSIS makes final the proposed performance standards
for RTE meat and poultry products.
Need for the Rule
This proposed action is compelled by recent outbreaks of
foodborne illness related to the consumption of adulterated RTE meat
and poultry products, as well as by the need to provide objective,
measurable pathogen reduction standards that can be met by official
establishments and compliance with which can be established through
Agency inspection. Although FSIS routinely samples and tests some
RTE products for the presence of pathogens prior to distribution,
there are no specific regulatory pathogen reduction requirements for
most of these products (e.g., there are no existing lethality
requirements for products such as hotdogs similar to the lethality
performance standards for roast beef). Except for cooked meat
patties (which currently have prescriptive time and temperature
requirements for lethality), roast beef products (which have the new
lethality performance standards), cooked poultry (which have the new
lethality performance standards), and canned meat and poultry (which
have the current prescriptive process requirements), the remaining
RTE meat and poultry products do not have regulation-specified
criteria for establishing safe processes other than the products
must not be adulterated. Therefore, to ensure the safety of these
products, FSIS is proposing performance standards for RTE and
partially heat-treated meat and poultry products.
The Sanitation Standard Operating Procedures (SOPs) and HACCP
regulations were intentionally written to allow the regulated
industry flexibility in the design of their procedures. FSIS is
adding, through this proposed rule, minimum criteria to be addressed
to prevent post-lethality contamination. In the Sanitation SOPs, the
proposed requirements will ensure that establishments maintain
minimal specific records and take specific action. If the
establishment determines that a hazard is reasonable likely to
occur, then the HACCP regulations will be addressed via CCPs and
related performance standards, controls, and records.
Performance standards are an integral part of the HACCP systems
in official meat and poultry establishments. HACCP provides the
framework for industry to set up science-based process controls.
Performance standards tell establishments what those controls need
to achieve for their HACCP plans to be effective and provide a
necessary measure of accountability for achieving acceptable food
safety. The proposed performance standards will provide meat and
poultry establishments with the incentive and flexibility to adopt
innovative, science-based processing procedures and controls; ensure
safety for consumers; and provide objective, measurable standards,
compliance with which can be determined through Agency inspection.
Therefore, FSIS believes that developing HACCP systems around
verifiable, objective performance standards is the most effective
way for establishments to consistently produce safe, unadulterated
meat and poultry products. Furthermore, by proposing performance
standards for pathogens whose destruction results in the destruction
of most or all other pathogens of concern, FSIS provides a reference
for establishments to use in gauging the efficacy of their HACCP
systems.
The proposed food-contact surface testing requirements are
compelled by the recent L. monocytogenes outbreak attributed to
contaminated hotdogs and the recent interagency draft risk
assessment \1\ concerning L. monocytogenes, which shows that there
is significant opportunity for recontamination of RTE meat and
poultry products during processing in the plant, after the lethality
is applied. These data indicate that many establishments that
produce RTE meat and poultry products are not effectively
implementing Sanitation SOPs so as to prevent direct contamination
of RTE meat and poultry products by L. monocytogenes. Therefore,
FSIS is proposing to require that all establishments that produce
RTE meat and poultry products conduct environmental testing of food-
contact surfaces for Listeria spp., after lethality treatment and
before final product packaging, unless they have identified L.
monocytogenes as a hazard reasonably likely to occur and so have
incorporated into their HACCP systems one or more controls validated
to eliminate it from their products. This testing will verify that
an establishment's Sanitation SOPs are preventing direct product
contamination by L. monocytogenes after the lethality treatment,
thus addressing the draft risk assessment assertion and other
research findings that RTE foods often are recontaminated by L.
monocytogenes after lethality is applied.
---------------------------------------------------------------------------
\1\ Center for Food Safety and Applied Nutrition, FDA, and FSIS,
``Draft Risk Assessment of the Public Health Impact of Foodborne
Listeria monocytogenes,'' January 19, 2001.
---------------------------------------------------------------------------
In regard to thermally processed, commercially sterile (most
often canned) meat and poultry products, the proposed standards
represent regulatory reform; they replace lengthy, prescriptive
regulations with performance standards that provide the same level
of food safety, as well as increased flexibility for establishments
to customize their processes under HACCP. Market Failure. Market
failure occurs here because consumers cannot identify (and reward)
those firms that both supply RTE products and implement the desired
food safety safeguards and consequently shift consumption away from
suppliers of products that may present a threat to public health.
These lower cost firms may not apply the most effective pathogen
prevention methods and could be supplying a product that could lead
to illness or death. Two main problems exist in many cases: lack of
definitive cause and effect between consumption of the product in
question and the illness or death (information gathering of
epidemiological evidence) and difficulty in identifying the source
of the original contamination (technical trace-back capabilities).
Clearly, no individual consumer who may be stricken with a foodborne
illness would have the means to overcome these two problems. The
proposed rule tries to remedy this market failure. This is
particularly true at this time with respect to L. monocytogenes.
Baseline
The most recent year in which both listeriosis cases and
economic background information on the affected industries are
available is 1997. The baseline analysis assumes that if no
regulatory-induced producer actions took place, these baseline
values would persist annually over a 10-year period. The analysis
then proceeds by introducing only those changes that are projected
to occur as a result of provisions of the proposed rule. Once these
provisions come into effect, benefits accrue in the form of
gradually reduced annual numbers of listeriosis cases and deaths,
while costs are registered in the form of higher compliance and
operating costs. This ceteris paribus assumption (all else held
constant while allowing for a change in one variable at a time) and
use of a static baseline avoids the thorny issue of forecasting the
nature and magnitude of non-regulatory induced industry and food
safety changes over this period not related to changes in regulatory
requirements. Both the ceteris paribus assumption and the static
baseline are standard analytical techniques used in economic
analysis.\2\ Section A discusses the nature of the industries likely
affected by the proposed rule (numbers and size of establishments
and type of products produced). This discussion is followed by a
discussion of the current regulatory environment that these
establishments operate within. Section C presents the baseline level
of listeriosis cases and deaths which anchors the expected benefits
of the proposed rule.
---------------------------------------------------------------------------
\2\ Samualson and Nordhaus, Economics, 16th Edition, McGraw Hill
Publishers, 1998.
---------------------------------------------------------------------------
A. The Nature of the Industries Affected and Current Industry
Practices
The 1997 Census of Manufacturers identifies 1630 establishments
that could be affected by the proposed rule. For this analysis,
these establishments are broken down into four broad groups
differentiated by the estimated costs of compliance with all of the
proposed provisions. The groups that would incur the greatest costs
include establishments that may have to revise their HACCP plans and
Sanitation SOPs in order to comply with both the proposed
performance standards and testing requirements. The number of
establishments,
[[Page 12622]]
the types of products shipped, and value of shipments of these
groups are summarized below (Table 1). The total value of shipments
of all of the products in 1997 totaled around $28 billion.\3\
---------------------------------------------------------------------------
\3\ These data were extrapolated from the 1997 Census of
Manufacturers. The actual data reported over $30 billion in
shipments, involving 1320 establishments, but did not account for
several important factors: specific volumes of product shipments
with meat and poultry, i.e., pizza, dinner entries, canned product
shipments with meat and/or poultry; scant information on size
distribution; and many missing values for important product classes.
In general, about 80 percent of these establishments produce mostly
cooked and otherwise processed meat and poultry products; the other
20 percent produce fermented, acidified, dried, salted cured, and
canned meat and poultry products.
---------------------------------------------------------------------------
These groups are further broken down into sub-groups where
appropriate.
The main product groups (and sub-groups, if appropriate) are:
Group I, those entities that likely will incur the greatest
costs and which are further broken down into:
Sub-group 1, RTE fermented, dried, and salt cured meat and
poultry products;
Sub-group 2, RTE hotdogs and wieners;
Sub-group 3, RTE frozen meat and poultry patties; and,
Sub-group 4, RTE smoked hams and poultry luncheon meats;
Group II, those entities that likely will incur moderate costs
and which are further broken down into:
Sub-group 1, meat processing establishments that make RTE boiled
hams, other sausages, and other frozen or cooked meats, such as
barbecue pork;
Sub-group 2, poultry processors that make RTE jellied goods and
other processed poultry products, including pate and spreads; and
Sub-group 3, combo plants who produce both RTE meat and poultry;
Group III, those entities that likely will incur minor costs;
representative products include RTE frozen dinners, pizzas, and
other frozen meat and poultry products; and
Group IV, those entities likely will incur no costs;
representative products include RTE canned meat and poultry
products.
Table 1.--Number, Type of Meat and Poultry Products (MPP's) Shipped, and Value of Product Shipments by Establishment Grouping, 1997
--------------------------------------------------------------------------------------------------------------------------------------------------------
Combo plants Processors (% of total)
Value of that slaughter -----------------------------------
Group-- subgroup Number of MPP's shipments in and process Examples of MPP's shipped
(% of total) millions (% of meat (% of Meat * Poultry Others **
total) total)
--------------------------------------------------------------------------------------------------------------------------------------------------------
I-All........................... 584 10537 77 421 86 0 Fermented, acidified, dried,
(36%) (37%) (5%) (26%) (5%) salt-cured products, hotdogs,
meat patties, and luncheon
meats.
I-1............................. 150 1590 28 122 0 0 [Fermented] dry or summer
(9%) (6%) (2%) (7%) sausage, salami, cured smoked
sticks, Lebanon bologna,
pepperoni, chorizo, poultry
mortadella, chicken/turkey
salami; [Dried] beef jerky,
dried beef or pork sticks,
dried beef slices, carne seca,
basturma, soujouk, manneh dry
duck breast, poultry jerky;
[Salt cured] country cured ham,
coppa, cappicola, prosciutto,
pancetta, dry cured duck;
[others] pickled pigs feet,
pickled meat/sausages, chorizo
with added vinegar, Hickory
farm beef sticks.
I-2............................. 167 2365 18 112 37 0 Frankfurters and wieners, turkey
(10%) (8%) (1%) (7%) (2%) and chicken franks.
I-3............................. 76 528 0 76 0 0 Sausage or meat and poultry
(5%) (2%) (5%) patties, fully cooked, uncured
meat patties.
I-4............................. 191 6054 31 111 49 0 Pastrami, bologna, roast beef,
(12%) (21%) (2%) (7%) (3%) bratwurst, bockwurst, poultry
and meat roll products.
II-All.......................... 791 12539 76 551 164 0 Otherwise processed meat and
(49%) (44%) (5%) (34%) (10%) poultry products.
II-1............................ 551 4883 0 551 0 0 Beef burritos, corned beef,
(34%) (17%) (34%) chili, frozen entrees and meat
soups, breakfast link,
meatballs, ravioli, pork and
beans, some poultry rolls,
other cooked poultry, pate,
meat and poultry spreads,
turkey BBQ, uncured meat
products, i.e. beef stew.
II-2............................ 164 6696 0 0 164 0
(10%) (24%) (10%)
II-3............................ 76 960 76 0 0 0 D.
(5%) (3%) (5%)
III............................. 104 2979 0 0 0 104 Frozen pizza with meat toppings;
(6%) (11%) (6%) frozen entries.
[[Page 12623]]
IV.............................. 151 2165 0 26 4 121 Canned products such as canned
(9%) (8%) (2%) (-%) (7%) Poultry spreads and spaghetti
sauce.
-----------------------------------------------------------------------------------------------------------------------
Total....................... 1630 28220.0 153 998 254 225 All of the Above.
(9%) (61%) (16%) (14%)
--------------------------------------------------------------------------------------------------------------------------------------------------------
* These processors make product from received meat carcasses and/or slaughter and process.
** Others include canners, frozen food makers, and other prepared food manufacturers.
Group I
Within Group I, 150 establishments produce fermented, dried, and
salt cured meat and poultry products (Sub-group 1). These
establishments make up nine percent of the total number of
establishments potentially affected by this proposed rule and ship
out about six percent of the total value of shipments. Over eighty
percent of these establishments are processors, over 95 percent of
who employ fewer than 500 employees.
The second sub-group within Group I consists of 167
establishments that make wieners and frankfurters. Eleven percent of
these establishments are combo plants, 67 percent are meat
processors, and 22 percent are poultry processors.
The third sub-group of 76 establishments within Group I produce
meat patties, some partially or fully cooked; all are classified as
meat processors by the Census. Almost all (98 percent) employ fewer
than 500 employees.
The final sub-group in Group I consists of 191 establishments
that make pastrami, bologna, roast beef, bratwurst, bockwurst,
smoked hams and picnics, and smoked poultry. Fifty-eight percent of
the establishments are meat processors; 16 percent, meat and poultry
combo plants; and 26 percent, poultry processors. Overall, eighty-
nine percent are small to mid-sized processors.
Group I also can be broken down into groups by type of
processing and whether they produce meat or poultry products. As a
whole, 87 percent (507) are processors (421 meat and 86 poultry
processors). Ninety-eight percent of the meat processors are made up
of either very small (employing fewer than 10 employees) or small
(employing more than 10, but fewer than 500 employees) operations,
with 36 percent being very small and 62 percent being small
operations. Only 2 percent of the establishments are considered
large (employing more than 500 employees). Poultry processors are
structured somewhat differently with 15 percent, being very small;
49 percent, small; and, 36 percent, large. Combining both meat and
poultry processors gives a slightly different picture of the
structure of processing with 32 percent classified as very small; 60
percent, small; and, 8 percent, large. The remaining 77
establishments (13 percent) in Group I are combo plants (which
slaughter animals and process meat products). On average, these
establishments have a smaller scale of operation than the group as a
whole, with 53 percent being very small; 38 percent being small; but
9 percent, being large.
Group II
These 791 establishments consist of just over 50 percent of the
total number of establishments and produce about 45 percent of total
value of product shipments (boiled hams, other smoked pork and
poultry products, other sausages, jellied goods, and other meat and
poultry products). Many of these products are used in the
manufacture of other food products or sold to distributors for
direct use by consumers. Seventy percent of these establishments are
meat processors (551); 20 percent (164) poultry processors; and, 10
percent (76) combo plants.
Sub-group 1 of Group II is composed of the 551 meat processing
establishments making boiled hams, other sausages, and other frozen
or cooked meats, such as barbecue pork. Sixty-two percent (339) of
these establishments are classified as small operations. Two percent
(12 establishments) are large, while the reminder (36 percent or 200
establishments) are very small.
Sub-group 2 of Group II consists of the twenty-percent (164) of
the establishments that are poultry processors. Forty-eight percent
(79) of these establishments are classified as small operations.
Fifteen percent (25) are very small, while 37 percent (60) are large
operations. The main products produced by these establishments
include jellied goods and other processed poultry products.
The remaining 10 percent (76) of the establishments in Group II
are combo meat plants (Sub-group 3). Seven percent (5) of these
establishments are classified as large operations, while the
majority (55%) are very small and another 38 percent are small.
Group III
These 104 establishments make frozen dinners, pizzas, meat and
poultry pies, and nationality foods containing meat and/or poultry.
They make up roughly 7 percent of the total number of establishments
and ship out over 10 percent of the total value of product
shipments.
Group IV
These 151 establishments produce canned products that contain
meat and poultry products. These establishments make up over 9
percent of the total number of establishments and about 8 percent of
the total value of shipments.
B. Current Regulatory Environment
Currently, all environmental testing for Listeria and the
development of either a Sanitation SOP measure or CCP for Listeria
is completely voluntary. Since 1987, FSIS has conducted a
microbiological testing program in which the Agency randomly
samples, in-plant, RTE meat and poultry products produced in
federally inspected establishments for L. monocytogenes, including
cooked and fermented sausages, cooked corned beef, sliced ham and
luncheon meats, beef jerky, cooked uncured poultry, and salads and
spreads. FSIS treats RTE products in which L. monocytogenes is found
as adulterated under the FMIA or the PPIA (21 U.S.C. 453(g) or
601(m)).
A recent industry survey gives some indication on the extent of
current environmental testing for Listeria.\4\ This survey was
conducted to determine what types of actions establishments took in
response to the FSIS Federal Register Notice of May 26, 1999 (64 FR
28351), asking establishments that produce RTE meat and poultry
products to reassess their HACCP plans to determine if L.
monocytogenes was a hazard reasonably likely to occur in their
processing. Because the respondents to this survey represent only a
small proportion of the total number of establishment that would
affected by the proposed regulations, the survey results may not
reflect a representative sample of the total population.
Nonetheless, these data represent the most comprehensive available
that reflects current industry practices.
---------------------------------------------------------------------------
\4\ The industry survey was sponsored by: National Food
Processors Association (NFPA), American Meat Institute (AMI),
National Turkey Federation (NTA), National Chicken Council (NCC),
National Meat Association (NMA), North American Meat Processors
(NAMP), Southwest Meat Association (SMA), and American Association
of Meat Processors (AAMP).
---------------------------------------------------------------------------
Approximately 308 establishments were contacted for the survey.
Of 271 respondents, 67 percent had an end-product testing program
for Listeria (88 percent of large plants, 64 percent of small plants
and 27 percent of very small plants). Over 90 percent of the
respondents conducted some type of
[[Page 12624]]
environmental testing (100 percent of large plants, 92 percent of
small plants, and 41 percent of very small plants). These survey
results suggests that most large establishments conduct both product
and environmental testing while many small and very small firms do
not.
The industry survey also found almost all (97%) of the large
establishments conducted at least some type of environmental
microbiological testing before the reassessment, but still, 39 of
the 74 large establishments, 58 of 193 small establishments, and
only one of 22 very small establishments added a CCP to their HACCP
plan in response to the reassessment (Table 2).
Table 2.--Estimated Establishments Adding LM Control Measures as a Result of LM Reassessment, Spring 2000
----------------------------------------------------------------------------------------------------------------
Percent Adding LM-
Add CCP Total number of related measures
Firm size addressing LM establishments to their HACCP
plans
----------------------------------------------------------------------------------------------------------------
Large.................................................. 39 74 52.70
Small.................................................. 58 193 30.05
Very Small............................................. 1 22 4.55
--------------------------------------------------------
Total.............................................. 98 289 33.91
----------------------------------------------------------------------------------------------------------------
Survey sponsored by: NFPA, AMI, NTF, NCC, NMA, NAMP, SMA, and AAMP.
The CCP addressing L. monocytogenes may or may not have included
testing, but involved remedial type actions, such as increased use
of disinfectants on processing surfaces. However, it does mean that
more than half of the establishments had not included L.
monocytogenes concerns in their HACCP plan before reassessment even
though microbiological testing was being conducted. Even after
reassessment when these additional establishments identified L.
monocytogenes concerns in their HACCP plans, microbiological testing
programs were included in only 21 percent of the establishments'
HACCP plans (or in 15 establishments' HACCP plans) and 41 percent of
the Sanitation SOPs of the establishments in this size category
(Table 3, below).
Table 3.--Percent of Establishments Surveyed With Microbiological testing Programs as Part of Either Their
Sanitation SOPs or HACCP Plans, Spring 2000
----------------------------------------------------------------------------------------------------------------
Either SSOP or
Firm size SSOPs HACCP HACCP
----------------------------------------------------------------------------------------------------------------
Large........................................................... 41 21 62
Small........................................................... 41 24 65
Very Small...................................................... 60 25 85
Weighted Average................................................ 43 23 66
----------------------------------------------------------------------------------------------------------------
Survey sponsored by: NFPA, AMI, NTF, NCC, NMA, NAMP, SMA, and AAMP.
Over 80 percent of the small establishments in the survey that
conduct some type of environmental microbiological testing, did so
prior to the reassessment. After reassessment, 58 out of the 193
small establishments added a CCP addressing L. monocytogenes to
their HACCP plans. Microbiological testing was included as part of
24 percent of these HACCP plans. Microbiological testing was
included in 41 percent of the Sanitation SOPs. Of the very small
establishments, only one added a CCP addressing L. monocytogenes to
their HACCP plan out of the 22 establishments surveyed. After
reassessment, microbiological testing programs were part of 25
percent of the establishments' HACCP plans in this size category and
60 percent of the Sanitation SOPs of the establishments in this size
category. In general, the survey results suggest that many
establishments have identified L. monocytogenes as an important
pathogen of concern and have included remedial measures in either
their Sanitation SOPs or CCPs in their HACCP plans and that
microbiological testing is more likely to be incorporated in
Sanitation SOPs than as part of a CCP in a HACCP plan.
C. Baseline Number of Listeriosis Cases and Deaths and the
Potential Benefits From the Proposed Rule
FSIS presents two baselines below for potential benefits from
the proposed rule. The first baseline is derived entirely from the
FDA-FSIS draft risk assessment. The second baseline is constructed
from two independent CDC-based studies. FSIS'' intent is to present
a range of possible benefits.
Baseline 1
The baseline numbers of listeriosis cases and deaths are taken
directly from the recent FDA-FSIS interagency draft risk assessment,
mainly Appendix 9, Table 1. The FDA-FSIS draft risk assessment ranks
20 categories of foods and provides a rigorous, systematic
assessment of the scientific knowledge to predict the relative
public health impact of exposure to L. monocytogenes. The FDA-FSIS
draft risk assessment shows that the following five factors affect
the contamination levels at the time of consumption: (1) the
frequency and extent of contamination at retail; (2) consumption
habits; (3) the growth potential of L. monocytogenes in foods; (4)
consumer storage practices; and (5) refrigeration temperatures. The
results of the FDA-FSIS draft risk assessment estimates 2540 annual
median U.S. listeriosis cases of which 1659 (65.3 percent) are
attributable to the consumption of RTE meat and poultry products.
The FDA-FSIS draft risk assessment not only provides the most
recent and complete analysis on sporadic U.S. listeriosis cases by
general product group, but it also provides insights into several
commodities' relative risk rankings and their contribution to the
total U.S. number of listeriosis cases. Deli-meats present the most
prominent risk to all sub-populations (Intermediate Age, Elderly,
and Perinatal), and are likely responsible for 1446 median U.S.
listeriosis cases (58.9 percent of the U.S. total), or 88.9 percent
of the listeriosis cases attributable to RTE meat and poultry
products.
Other specific products within the meat and poultry product
category identified by the FDA-FSIS draft interagency risk
assessment as posing a risk related to listeriosis are: deli salads
containing meat and poultry products (at the median, 3.8% of all
listeriosis cases or 5.8% of listeriosis cases attributable to RTE
meat and poultry products); frankfurters (at the median, 3.5 and 5.4
percent, of the total and all RTE meat and poultry products
listeriosis cases, respectively); pate (at the median, 0.9 and 1.4
percent, respectively, for total and all RTE
[[Page 12625]]
meat and poultry products listeriosis cases); and, dry fermented
sausage (at the median, 0.2 and 0.3 percent, respectively, for total
and all RTE meat and poultry products listeriosis cases). The FDA-
FSIS interagency draft risk assessment model anchors the median
number of listeriosis cases on epidemiologic surveillance data
(FoodNet) without bounding the 5th and 95th percentiles of the
estimated number of cases attributable to each product category.
Table 4, based on the FDA-FSIS interagency draft risk assessment,
provides the total number of listeriosis cases across age groups for
each product category for the 5th and 95th percentiles:
Table 4.--Summary FDA-FSIS Draft Risk Assessment Results Concerning Total Predicted US Listeriosis Cases of Foodborne Origin
--------------------------------------------------------------------------------------------------------------------------------------------------------
Statistics \1\ Relative risk ranking \2\ Etiologic fraction of cases As a percent
------------------------------------------------------------ attributed to each product of total cases
category at the 5th and 95th in their
Product category percentiles \5\ product class
5th 95th Med.\4\ 1 2 3 -----------------------------------------------
5th 95th Med.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Smoked Seafood.............................. 1 2464 33 6 6 7 1 1 61
Raw Seafood................................. 0 35 0 17 20 17 0 0 0
Preserved Fish.............................. 0 300 3 13 13 13 0 0 6
Cooked Crustaceans.......................... 0 1415 18 9 8 9 0 1 33
Total Seafood............................... 1 4214 54 Vary Vary Vary 1 2 100
Vegetables.................................. 0 7311 15 11 9 11 0 4 87
Fruits...................................... 0 900 2 16 14 14 0 1 13
Vegetables/Fruits........................... 0 8211 17 Vary Vary Vary 0 5 100
Dairy Products.............................. 26 19481 523 Vary Vary Vary 28 12 NA
Frankfurters................................ 3 6324 90 4 5 4 3 4 5
Dry/Semi-Dry Fermented Sausages............. 0 631 5 12 12 12 0 0 0
Deli Meats.................................. 50 98261 1446 1 1 1 55 59 87
Pate and meat spread........................ 1 1152 23 8 7 8 1 1 1
Meat or Poultry Deli Salad \3\.............. 3 7146 96 2 3 3 3 4 6
Total RTE Meat and Poultry Products......... 57 113514 1660 Vary Vary Vary 62 68 100
Non-Meat or Poultry Deli Salad.............. 5 21437 287 2 3 3 2 13 NA
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Horizonal summation of listeriosis cases across age group for each product category in Table 1, Appendix 9 of the FDA-FSIS interagency draft risk
assessment (page 342).
\2\ 1= Intermediate; 2= Elderly; and, 3=Peri-natal. The relative risk ranking is taken directly from Table V-3 of the FDA-FSIS interagency draft risk
assessment (p. 108).
\3\ Meat deli salad estimate is based on FDA-FSIS draft risk assessment estimate of 26 deaths from deli salads and assuming that 25 percent is due to
deli salads containing meat and poultry product's (their relative proportion of total deli salad consumption).
\4\ Med. = Median.
\5\ The etiologic fraction is calculated as the proportion of listeriosis cases associated with each product category at the 5th and 95th percentiles.
The number of listeriosis cases attributable to ready-to-eat
meat and poultry products is 62% (1562 cases) at the 5th percentile
and 68.0% (1727 cases) at the 95th percentile based on a median
number of annual cases (2540 cases). This sensitivity about the
median number of listeriosis cases attributable to meat and poultry
products was calculated by summing the number of listeriosis cases
attributable to each meat and poultry product category
(frankfurters, dry and semi-dry sausage, deli meats, and pate and
meat spreads) and 25% (based on one-fourth of all deli salad
servings containing meat and poultry products, CSFII 1994-1996
survey data) of the deli salad category \5\ for the 5th and 95th
percentile. The total number of listeriosis cases attributable to
meat and poultry products for each product category in the 5th
percentile was divided by the total number of listeriosis cases for
all RTE products at the 5th percentile. A similar calculation was
done at the 95th percentile. These etiologic fractions of the number
of listeriosis cases provide a plausible range for the estimated
number of listeriosis cases attributable to RTE meat and poultry
products.
---------------------------------------------------------------------------
\5\ One-fourth of all deli salads consumed contain RTE meat and
poultry products based on the 1994-1996 Continuing Survey of Food
Intakes by Individuals used in the FDA-FSIS interagency risk
assessment.
---------------------------------------------------------------------------
FDA-FSIS interagency draft risk assessment reports results for
three specific age groups: perinatal (which includes fetuses and
newborns from 16 weeks after fertilization to 30 days after birth),
elderly (which includes people 60 or more years of age), and
intermediate age (everyone else). The FDA-FSIS interagency draft
risk assessment model predicts the number of deaths associated with
each RTE food category. The estimated number of listeriosis cases
presented in the FDA-FSIS draft risk assessment (Table 1, Appendix
9) is based on the assumption of an overall case-fatality rate of
0.20.\6\ This assumption is supported by a study of foodborne
illnesses in the United States, Mead et al. (1999), which is based
on published reports and unpublished CDC data, and is consistent
with epidemiololgic surveillance case-fatality data across all age
groups (Table 5).
---------------------------------------------------------------------------
\6\ The number of neonatal deaths was multiplied by 2.5 to
adjust the combined prenatal and neonatal deaths to a case-fatality
rate constrained at approximately 20% in the FDA-FSIS interagency
risk assessment. This adjustment was made to account for
underreporting of prenatal infections resulting in premature
termination of pregnancy.
[[Page 12626]]
Table 5.--Listeria Cases by Age Class and Year
----------------------------------------------------------------------------------------------------------------
Perinatal
Age class 1996 1997 1998 1999 1996-99 % Cases adjustment
factor
----------------------------------------------------------------------------------------------------------------
0-1, unadjusted................... 8 5 10 12 35 ......... 2.5
Perinatal, adjusted............... 20 13 25 30 88 20 ..........
1-9............................... 1 2 1 3 7 2 ..........
10-19............................. 3 1 2 1 7 2 ..........
20-29............................. 4 3 6 5 18 4 ..........
30-39............................. 6 9 13 7 35 8 ..........
40-49............................. 3 6 6 8 23 5 ..........
50-59............................. 4 9 13 16 42 10 ..........
>60............................... 37 42 61 48 188 45 ..........
``Unknown''....................... 0 0 0 14 14 3 ..........
-----------------------------------------------------------------------------
Totals........................ 78 85 127 132 422 100 ..........
----------------------------------------------------------------------------------------------------------------
There is some uncertainty surrounding the assumed 20 case-
fatality rate. The FDA-FSIS interagency draft risk assessment
observes that if the susceptibility among the three age-based groups
varies, then the ratio of serious illness to mortality may differ
among these groups. This is consistent with epidemiologic data for
listeria mortality age distribution unadjusted for underreporting
and mis-classification of pre-natal cases. Other considerations
include the fact that epidemiolgic surveillance data do not count
unborn fetuses as deaths, but as miscarriages and stillbirths, which
may contribute to underreporting within this age category (PHS,
1994).
The epidemiologic data also contains cases with an ``unknown''
age. In the 1999 data, there were 14 cases reported as ``unknowns.''
Epidemiologists at the FoodNet sites indicated that the ``unknown''
ages resulted from database errors and are not a result of a
systematic classification error.
Table 6 presents the Listeria mortality age distribution,
unadjusted for the underreporting or mis-classification of pre-natal
cases (the ``unknowns'' age cases were not included in the data
set). This unadjusted data suggests and overall case-fatality rate
of 15%, and substantial variation of the case-fatality among the age
categories.
Table 6.--Listeria Mortality Age Distribution, Unadjusted for Under-Reporting of Pre-Natal Cases
----------------------------------------------------------------------------------------------------------------
Age class (yrs) Dead Total cases Mortality
----------------------------------------------------------------------------------------------------------------
0-1............................................................. 1 23 4
1-9............................................................. 0 4 0
10-19........................................................... 0 6 0
20-29........................................................... 0 13 0
30-39........................................................... 1 28 4
40-49........................................................... 3 15 20
50-59........................................................... 4 26 15
>60............................................................. 29 140 21
-----------------------------------------------
Totals...................................................... 38 255 15
----------------------------------------------------------------------------------------------------------------
Source: FoodNet 1996-98, unpublished CDC data.
While it is unlikely that all of the ``unknown'' age cases would
be in the perinatal category due to National Health Statistics
standards for classification of fetal deaths, a bound for the
largest possible case-fatality rate can be derived with the 14
``unknown'' age cases in this age category as seen in Table 7.
Table 7.--Listeria Mortality Age Distribution, Adjusted for Under-Reporting of Pre-Natal Cases
----------------------------------------------------------------------------------------------------------------
Age class (yrs) Dead Total cases % Mortality
----------------------------------------------------------------------------------------------------------------
Perinatal....................................................... 15 37 41
1-9............................................................. 0 4 0
10-19........................................................... 0 6 0
20-29........................................................... 0 13 0
30-39........................................................... 1 28 4
40-49........................................................... 3 15 20
50-59........................................................... 4 26 15
>60............................................................. 29 140 21
-----------------------------------------------
Totals...................................................... 52 269 19
----------------------------------------------------------------------------------------------------------------
[[Page 12627]]
While the estimated overall case-fatality rate of 19% is
consistent with the Mead et al. (1999) estimate of 20%, uncertainty
regarding the age-specific case-fatality rate due to
misclassification and underreporting remain.\7\ Given disparate
opinions on case-fatality rates by age group, it is difficult to
come up with a point estimate for benefit of this rule based on
available data. However, the following preliminary benefits analysis
provides two point estimates based on two baseline approaches. It
should be noted that there is considerable uncertainty in the
benefits analysis below, which is recognized throughout this section
and again addressed in the ``Uncertainty'' section.
---------------------------------------------------------------------------
\7\ Public Health Service, Medical Examiners' and Coroners'
Handbook on Death Registration and Fetal Death Reporting. (Reprinted
1994).
---------------------------------------------------------------------------
Attaching Economic Value to the Number of Listeriosis Cases and Deaths
The listeriosis cases and deaths attributable to RTE meat and
poultry products estimates derived from the FDA-FSIS draft risk
assessment establish the number of lives lost and those temporarily
hospitalized or unable to work as a result of illness. This cost may
be measured in lost productivity and in medical costs incurred. The
Economic Research Service has conducted research on the method.
However, given many uncertainties, FSIS is not monetizing the values
associated with reducing listeriosis cases and deaths. FSIS requests
comment on appropriate methods to value listeriosis cases and
deaths.
Baseline 2
This second baseline derives the number of listeriosis cases and
deaths from two independent studies: one by Olsen \8\ and one by
Mead.\9\
---------------------------------------------------------------------------
\8\ Olsen, Sonja, et al., ``Surveillance for Food borne Disease
Outbreaks--United States, 1993-1997,'' Morbidity and Mortality
Weekly Report, March 17, 2000.
\9\ Mead, Paul S., et al., ``Food-Related Illness and Death in
the United States,'' Emerging Infection Diseases, 5:5, September-
October, 1999.
---------------------------------------------------------------------------
The Olsen Study: Olsen estimated the number of cases and deaths
from all foodborne diseases in several U.S. states and found that
meat and poultry products were responsible for 8 to 20 percent of
all foodborne cases and deaths, respectively (Table 8).
Table 8.--Number of U.S. Food Borne Disease Outbreaks, Cases, and Deaths by Vehicle of Transmission
--------------------------------------------------------------------------------------------------------------------------------------------------------
All known food borne diseases Meat and poultry products Percent attributable to meat and
------------------------------------------------------------------------------- poultry products
Year --------------------------------------
Outbreaks Cases Deaths Outbreaks Cases Deaths Outbreaks Cases Deaths
--------------------------------------------------------------------------------------------------------------------------------------------------------
1993.............................. 489 17477 9 28 1797 5 6 10 56
1994.............................. 653 16234 3 51 1804 1 8 11 33
1995.............................. 628 17800 11 35 1144 1 6 6 9
1996.............................. 477 22607 4 23 992 0 5 4 0
1997.............................. 504 11940 2 31 972 0 6 8 0
---------------------------------------------------------------------------------------------------------------------
Total......................... 2751 86058 29 168 6709 7 6 8 24
5-yr Avg.......................... 550 17212 6 33.6 1342 1 6 8 20
--------------------------------------------------------------------------------------------------------------------------------------------------------
Source: Surveillance for Food borne Disease Outbreaks--United States, 1993-1997. Olsen, Sonja et al.---- See tables 17 to 21.
If the percentage of listeriosis cases and deaths attributable
to meat and poultry products is the same as the percentage
attributable to foodborne diseases, the 8-percent estimate from the
Olsen study can be used to estimate the number of listeriosis cases
and deaths due to consumption of RTE meat and poultry products.\10\
This assumption may not be accurate. Olsen's study is a summary of
reported foodborne disease outbreaks. However, FoodNet surveillance
data indicate that the majority of listeriosis cases are sporadic
with no identified link to any other case. Furthermore, sporadic
disease may reflect entirely different food vehicles, mechanisms, or
sources of infection than those responsible for outbreaks.
---------------------------------------------------------------------------
\10\ Originally, deaths were calculated using the 0.276
estimate, but was found to produce an unrealistically high level of
deaths. The 0.08 estimate produced results more in line with the
number of listeriosis deaths reported by Mead.
---------------------------------------------------------------------------
With these reservations in mind, FSIS applied the 8-percent
estimate from the Olsen study to the Mead data (2500 cases and 499
deaths) for listeriosis (after developing a 5-year time series set
of estimated listeriosis cases and deaths), which gave an average
annual listeriosis case and death load of 186 and 38, respectively
(Table 9). For example, the 1993 estimate of listeriosis cases and
deaths was calculated by multiplying 0.08 times 2359 (189) and 0.08
times 745 (60), respectively for cases and deaths.
Table 9.--Estimated Number of U.S. Food Borne Disease Cases and Deaths: Total From All Pathogens, Total From LM, Total From LM in RTE Meat and Poultry
Products (MPP's) Food Products as Derived From a /Combination of the Mead-Olsen Studies
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cases and deaths Listeriosis cases Listeriosis cases Listeriosis cases
from all food borne and deaths through and deaths through and deaths through
Year diseases food borne sources MPP's RTE MPP's
---------------------------------------------------------------------------------------
Cases \1\ Deaths Cases Deaths Cases Deaths Cases Deaths
--------------------------------------------------------------------------------------------------------------------------------------------------------
1993............................................................ 11796975 2700 2359 745 189 60 170 54
1994............................................................ 10957950 900 2192 248 175 20 158 18
1995............................................................ 12015000 3300 2403 911 192 73 173 66
1996............................................................ 15259725 1200 3052 331 244 26 220 24
1997............................................................ 8059500 600 1612 166 129 13 116 12
---------------------------------------------------------------------------------------
Total \2\................................................... 58089150 8700 11618 2401 929 192 837 174
5-yr Avg........................................................ 11617830 1740 2324 480 186 38 167 35
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ It is assumed that the terms, illnesses as in Mead et al., and cases in Olsen et al., report, can be used interchangeably.
\2\ May not add due to rounding.
[[Page 12628]]
Finally, the estimated number of cases and deaths due to
listeriosis attributable to meat and poultry product consumption
must reflect only that portion that is RTE. One method to do this is
simply to assume that 90 percent of the meat and poultry product
listeriosis cases and deaths are linked to RTE food products.
Obviously this estimate is completely arbitrary. FSIS does not
contend that this is an accurate depiction: therefore, FSIS solicits
comments. Using this estimate, the number of listeriosis cases and
deaths attributable to RTE meat and poultry product consumption is
estimated at 167 and 35, respectively. Also, FSIS considered making
an adjustment factor for the effectiveness of the provisions in the
proposed rule. Again, FSIS is unsure how such an adjustment factor
would be constructed, but recognizes that not all listeriosis cases
and deaths could be totally eliminated by provisions in the proposed
rule. FSIS requests comment on the efficacy of the proposed testing
provisions.
Request for Comment
FSIS solicits comments and suggestions concerning the issues of
the baseline number of listeriosis cases and deaths attributable to
RTE meat and poultry products and the effectiveness of measures
prescribed by the proposed rule. Notably, the recent FDA-FSIS draft
risk assessment estimated that 65.3 percent of all U.S. listeriosis
cases and deaths (or 1660 cases and 322 deaths per year) are
attributable to the consumption of RTE meat and poultry products.
The number of cases and deaths estimated by the FDA-FSIS draft risk
assessment are 9.9 times greater than the estimated numbers obtained
from the second baseline. FSIS welcomes comments and suggestions on
the kinds of data and information needed to construct alternative
baselines and sensitivity approaches to test baseline listeriosis
cases and deaths and program effectiveness.
Projected Industry Costs
1. Mandatory Food Contact Surface Testing for Listeria spp.
FSIS is proposing to require that all establishments that
produce RTE meat and poultry products conduct environmental testing
of food-contact surfaces for Listeria spp., after lethality
treatment and before final product packaging, unless they have
identified L. monocytogenes as a hazard reasonably likely to occur
and so have incorporated into their HACCP systems one or more
controls validated to eliminate it from their products. This testing
will verify that an establishment's Sanitation SOPs are preventing
direct product contamination by L. monocytogenes after the lethality
treatment, thus addressing the risk assessment assertion that RTE
foods often are recontaminated by L. monocytogenes after lethality
is applied.
After an establishment finds one of its food contact surfaces to
be positive for Listeria spp., it must take corrective actions
defined in its Sanitation SOPs that must include product testing, as
well as any other activities that it deems necessary to determine
and demonstrate that the affected lot or lots of product are not
adulterated with L. monocytogenes. The establishment must have in
place procedures: to determine which lots of product might be
affected; to hold, sample, and test that product; and to dispose of
affected product appropriately.
Establishments can be expected to face at least three potential
cost impacts due to mandatory food contact surface testing for
Listeria spp. testing. These potential impacts could arise from: (1)
the need to make major revisions in their HACCP plan(s); (2)
additional verification testing; and, (3) the need to make major
changes in their production process and/or production output mix.
The first and second impacts are closely related because the
firms that elect to revise their HACCP plan to incorporate a CCP
addressing Listeria will not be required to test for it at the
prescribed level for those incorporating Listeria testing in the
Sanitation SOPs. HACCP provides the opportunity for greater latitude
in establishing more science-based verification approaches, which
may include testing. Thus, some estimate on the number of firms
expected to incorporate a CCP addressing Listeria as a result of
this provision is necessary for this analysis to proceed. The higher
this estimate, the higher will be the expected costs to validate
needed HACCP modifications, and lower will be the expected costs of
the proposed testing requirements.
The third impact stems from the decision by some establishments
to drop certain RTE meat and poultry products (or drop out of
production altogether). This decision would be due to persistently
high rates of positive Listeria spp. food contact surface testing
results and the subsequent increased amount of product being held
while awaiting confirmation that positive food contact surface test
results for Listeria spp. did not result in contaminated product.
This creates the prospect of an additional fourth potential
impact: the potential increased cost associated with greater volumes
of product held by establishments in a ``test and hold'' pattern.
These costs are expected to be particularly relevant to those firms
experiencing very poor testing results, presumably as a result of
inadequate sanitation controls. These costs are discussed separately
in the section entitled ``C. Projected Costs Associated with
Expected Production Adjustments.'' There, FSIS explains that
establishments that encounter ``Stage 2'' and ``Stage 3'' type
problems with chronic Listeria spp. or L. monocytogenes
contamination either incur substantial remediation costs or elect to
exit RTE meat and poultry product production. FSIS lacks data to
adequately estimate the volumes of product that establishments may
have to test and hold and the resulting costs. See the section
entitled ``Uncertainty'' for further discussion.
Each of the three cost impacts is discussed below.
A. Projected Costs Associated With HACCP Plan Validation
FSIS estimates that currently 397 establishments have a CCP
addressing Listeria in their HACCP plan and that 257 additional
establishments will do so as a result of the proposed rule. That is,
the number of establishments with a CCP addressing L. monocytogenes
is projected to increase nearly 65 percent as a result of this
provision of the proposed rule (from 397 to 654). FSIS bases these
estimates on judgment and information presented previously in the
discussion on baseline industry practices. Main factors considered
in FSIS's estimates pertaining to current and projected behavior
related to firms' decision to modify their HACCP plans include:
FSIS estimates that the percentage of the large
establishments, excluding canners, that have a CCP addressing L.
monocytogenes in their HACCP plans will increase from 50 to 100
percent (from 67 establishments to 133 establishments) \11\ as a
result of the proposed rule;
---------------------------------------------------------------------------
\11\ These numbers are derived from the total number of firms
listed in Table 3 of section XII of the proposed rule preamble,
``Compliance with Regulatory Flexibility Act of 1966.''
---------------------------------------------------------------------------
FSIS estimates that the percentage of the small
establishments, excluding canners, that have a CCP addressing L.
monocytogenes in their HACCP plans will increase from 33 to 50
percent (from 280 establishments to 420 establishments) as a result
of the proposed rule; and,
FSIS estimates that the percentage of the very small
establishments, excluding canners, that have a CCP addressing L.
monocytogenes in their HACCP plans will increase from 10 to 20 (from
51 establishments to 101 establishments) percent as a result of the
proposed rule.
The net results on the number of establishments with a CCP
addressing Listeria in response to the proposed rule is given in
Table 10 below. FSIS has excluded canners from total in the
following table (resulting in a grand total of 1479: 1630 total
minus 151 canners). FSIS expects that canners should only experience
minimal costs from identifying that their existing CCPs already
eliminate L. monocytogenes from their products.
[[Page 12629]]
Table 10.--Summary of Current and Projected Establishment Behavior With Respect To Their Decision To Incorporate
a CCP Addressing L Monocytogenes
----------------------------------------------------------------------------------------------------------------
Number of establishments
Item -------------------------------- Change
Before After
----------------------------------------------------------------------------------------------------------------
Establishments that currently have or will develop a CCP addressing L. monocytogenes in their HACCP plan that
also:
----------------------------------------------------------------------------------------------------------------
Conduct food contact surface testing............................ 299 \12\ 489 190
Do not conduct food contact surface testing..................... 98 165 67
-----------------------------------------------
Sub-total................................................... 397 654 257
----------------------------------------------------------------------------------------------------------------
Establishments without and that will not develop a CCP addressing L monocytogenes in their HACCP plan that also:
----------------------------------------------------------------------------------------------------------------
Conduct food contact surface testing............................ 645 825 180
Do not conduct food contact surface testing..................... 437 0 -437
-----------------------------------------------
Sub-total................................................... 1082 825 -257
===============================================
Grand-Total............................................. 1479 1479 0
----------------------------------------------------------------------------------------------------------------
The size distribution of establishments expected to modify their
HACCP plans has important implications in the analysis on mandatory
food contact surface testing. This analysis assumes that all large
establishments are likely to incorporate a CCP addressing L.
monocytogenes in their HACCP plans, while most small and very small
establishments will not (instead relying on Sanitation SOPs to
address L. monocytogenes and comply by mandatory testing). That is,
larger establishments (who have the greatest volume, currently
conduct a high volume of product and food contact surface
microbiological testing and maintain CCPs addressing L.
monocytogenes) will not be required to test, thus reducing the
overall testing brunt of this provision. The current high numbers of
large establishments with CCPs addressing L. monocytogenes, and the
expectation that all remaining ones will modify their HACCP plans
strongly influence this outcome.\13\ This leaves the smaller
establishments to feel the brunt of mandatory food contact surface
testing burden while at the same time, lowering the total level of
testing needed to comply with the proposed rule.
---------------------------------------------------------------------------
\12\ This increase in this field is due to the number of
establishments currently testing that choose to also develop a CCP
in response to the rule. FSIS assumes that they will continue
testing, so this number does not represent an increase in the number
of establishments that test.
\13\ It must be kept in mind that although larger establishments
will avoid mandatory testing at the prescribed frequency, nothing
suggests that these establishments will discontinue their testing
programs and jeopardize their product integrity. It is expected that
the original product integrity be maintained through its own HACCP
monitoring and verification activities and confirmed through FSIS
verification of their HACCP plans.
---------------------------------------------------------------------------
One element that may increase the over-all cost of the HACCP
modification component of mandatory testing at the prescribed
frequency is if establishments need to modify more than one HACCP
plan. Also, the relative of cost of testing versus developing a CCP
would not be the only factor in an establishment's decision on how
to comply with the proposed requirement. Unique aspects of ad
establishment's processing system, as well as the relative risks
posed by its products, may influence an establishment's decision.
FSIS request comment on this issue.
FSIS has found that the costs associated with modification of
HACCP plans can range from $2,000 to $20,000 per HACCP process. This
cost depends on the efforts needed to draw up new CCPs (sanitation
practices to limit levels of L. monocytogenes on incoming raw
product and prevent recontamination after processing, lethality
steps, or testing to validate and verify its controls); install
monitoring equipment (thermometers and test kits) and; train labor
to take additional samples and to keep records. The cost of $5000
for the incorporation of a CCP addressing L. monocytogenes into an
establishment's HACCP plan is used in cost projections for this
analysis, regardless of size of establishment or number of HACCP
plans per establishments. This cost is considered a one-time event
(minimal recurring monitoring costs are assumed to result from the
inclusion of a CCP addressing L. monocytogenes). Any additional
costs associated with its' monitoring are subsumed in the over-all
monitoring cost of the establishment's current HACCP plan(s).
Industry-wide, these total one-time HACCP validation costs are
estimated at $1.285 million ($5000 times 257 establishments). FSIS
requests comment on this estimated total cost of HACCP plan
modification.
B. Projected Costs Associated With Additional Testing
For those establishments not currently testing or that do not
maintain a CCP addressing Listeria, FSIS tentatively concludes that
food contact surface testing and Sanitation SOP controls will supply
the same reassurance that L. monocytogenes is not a potential food
safety problem as do regularly scheduled verifications of Sanitation
SOPs. As was discussed, the proposed rule effectively exempts
establishments from mandatory testing if: (1) they manufacture
products whose processing destroys L. monocytogenes and/or
eliminates any opportunity of recontamination, e.g., canners; or
(2), if they previously identified L. monocytogenes as a hazard
reasonably likely to occur and have incorporated one or more
controls into their HACCP systems. These two conditions effectively
exempts 151 establishments identified as canners and 397
establishments identified as currently having a CCP addressing L.
monocytogenes in their HACCP plan. In addition, FSIS projects that
an additional 257 establishments will elect to incorporate a CCP
addressing L. monocytogenes into their HACCP plan, effectively
avoiding this mandatory testing requirement. Thus, FSIS estimates
that this provision will impose mandatory testing costs on 825
establishments (1630-151-397-257=825).
Nature of Testing (Areas to be tested, Frequency, and
Consequences). All environmental tests will be made on food-contact
surfaces (rather than non-food contact surfaces, such as floors and
drains). Reliance on food contact surface testing is predicated on
the logic that establishments, in the desire to minimize their
chances of having a positive food product test, will use surface
test results as a leading indicator of food product safety. Thus, no
non-food product contact testing is required in this proposed rule
change. Also, non-food product contact has not been found to be
related with final product safety: ``Areas where products are stored
or processed are of lower priority because inadequately cleaned
equipment in raw processing areas have not been associated with a
problem of Listeria monocytogenes in finished product.'' \14\
---------------------------------------------------------------------------
\14\ Guidelines to Prevent Post-Processing Contamination from
LM, Tompkin, Scott, Bernard, Sveum and Gombas, Dairy, Food and
Environmental Sanitation, August 1999, Vol. 19, No. 8, Pages 551-
562.
---------------------------------------------------------------------------
The frequency of food contact surface testing is based on the
following:
(a) Four tests per active line \15\ per month for large
establishments;
---------------------------------------------------------------------------
\15\ Why lines? Many authorities recommend considering each
product line as a critical control point. For example, ``Each
packaging line should be regarded as an independent unit for LM
monitoring and control,'' Guidelines to Prevent Post-Processing
Contamination from LM, pp. 551-562.
---------------------------------------------------------------------------
[[Page 12630]]
(b) Two tests per active line per month period for small
establishments; and,
(c) One test per active line per month for very small
establishments.
For purposes of this cost analysis below, FSIS used the
following assumptions on the average number of operating lines per
establishment: 2 lines for very small establishments; 4 lines for
small establishments; and, 6 lines for large establishments.
These frequencies are intended to be the minimum level of food
contact surface testing undertaken by firms. Greater frequency of
testing by establishments (regardless of size) is encouraged by
FSIS: FSIS policy states that the more the plant is testing, the
less likely FSIS will include the plant's product in its end-product
microbiological testing program(s) (FSIS Directive 10,240.2,
Revision 1). This testing frequency incorporates the volume of
production in two ways: (1) It assumes that the more an
establishment produces, the more lines it has, and (2) the greater
its size, the more product is produced and thus, a need for higher
weekly frequency as size increases.\16\ FSIS requests comment on
these proposed testing frequencies.
---------------------------------------------------------------------------
\16\ The higher testing frequency for large establishments (once
per week per line) also reflects the greater potential of large
establishments to contaminate larger volumes of product than small
and very small establishments.
---------------------------------------------------------------------------
Positive test results on food-contact areas will indicate a need
to thoroughly clean the immediate working areas and equipment and
re-test. Once a positive food contact surface is found, product
samples will be tested for L. monocytogenes. The establishment must
have in place procedures to determine which lots of product might be
affected; to hold, sample, and test that product; and to dispose of
affected product and to correct and prevent further contamination
appropriately.
The potential cost of mandatory testing is a function of the
per-unit testing cost \17\ and of the number of establishments (and
the number of lines that each establishment maintains) that are
affected by this provision. Several testing firms were contacted
concerning their testing kits for Listeria spp. The cost of these
tests varied from $10 to $30, not including the costs for labor and
shipping the material to the laboratory. One would expect that the
costs of in-house testing would be at least the amount charged by
firms engaged in providing this service. A slightly higher cost of
$35 per test is used as the average cost of testing food-contact
areas for Listeria spp. in this analysis to compensate for expenses
associated with labor to conduct the test and shipping tests to
laboratories for analysis.
---------------------------------------------------------------------------
\17\ No adjustment is made to account for the degree to which
plants currently test: the baseline discussion suggests that many
firms are currently conducting some kind of environmental testing
program.
---------------------------------------------------------------------------
The number of establishments that will face mandatory testing
has been determined in the previous analysis. Recall that it found
that all large establishments are expected to modify their HACCP
plans and be exempt from mandatory food contact surface testing. The
finding implies that only small and very small establishments will
need to test to satisfy compliance of the proposed rule. FSIS
estimates that 50,035 tests will be needed by these establishments
(Table 11). The associated overall costs of these tests is estimated
at $1.75 million ($35 times 50,035). This cost would be expected to
recur annually.
---------------------------------------------------------------------------
\18\ This increase in this field is due to the number of
establishments currently testing that choose to also develop a CCP
in response to the rule. FSIS assumes that they will continue
testing, so this number does not represent an increase in testing.
Table 11.--Summary of Number of Tests Conducted by Establishments With and Without CCPs Addressing L.
Monocytogenes
----------------------------------------------------------------------------------------------------------------
Number of tests needed to meet
compliance
Item -------------------------------- Change
Before After
----------------------------------------------------------------------------------------------------------------
Establishments that currently have or will develop a CCP addressing L. monocytogenes in their HACCP plan that
also:
----------------------------------------------------------------------------------------------------------------
Conduct food contact surface testing............................ 39105 \18\ 67458 +28353
Do not conduct food contact surface testing..................... 8141 13594 + 5453
-----------------------------------------------
Sub-total 1................................................. 47246 81053 + 33807
----------------------------------------------------------------------------------------------------------------
Establishments currently without and that will not develop a CCP addressing Listeria monocytogenes in their
HACCP plan that also:
----------------------------------------------------------------------------------------------------------------
Conduct food contact surface testing............................ 63524 50035 -13489
Do not conduct food contact surface testing..................... 20318 0 -20318
-----------------------------------------------
Sub-total 2................................................. 83842 50035 -33807
===============================================
Grand-Total (1+2)....................................... 131088 131088 0
----------------------------------------------------------------------------------------------------------------
C. Projected Costs Associated With Expected Production Adjustments
In addition to the above two expected industry costs
(administrative costs related to incorporating a CCP addressing L.
monocytogenes in their HACCP plans and increased food contact
surface testing costs), some firms--across all size categories--may
need to adjust their production process or facilities to comply with
the proposed rule. One can view such adjustments as being on a
continuum, from the most minor--and least costly--to the most
radical--and costly--adjustments needed to remedy their L.
monocytogenes-related control problem(s). Because measures vary
greatly across establishments and product-types, it is difficult to
estimate the impact of eventual firm adjustments arising from this
provision of the proposed rule.
For purposes of analysis, affected establishments are broken
into four groups: those that are not expected to encounter any
problems as a result of mandatory testing; those firms that are
expected to encounter minor problems (Stage 1 problems); those firms
that are expected to encounter more serious problems and higher
costs to remedy their L. monocytogenes-related problems (Stage 2
problems); and, a small group that will drop certain products or
drop production entirely due to persistent L. monocytogenes positive
findings (Stage 3 problems). Based on the discussion that follows,
the number of establishments in each group was determined to be:
1,258 establishments that will not encounter any problems; 104
establishments that will encounter Stage 1 and 2 problems and 13
establishments that drop production of certain RTE meat and poultry
products or drop out of the industry entirely (Table 12).
Steps to prevent L. monocytogenes contamination can take many
forms: pre-operational (building and facility design; equipment
design and maintenance) and operational (adequate attention paid by
well-trained employees). Most establishments are assumed to follow
the recommended guidelines in production,\19\ are already doing some
testing (either food contact surface or
[[Page 12631]]
of products), and would not be expected to experience any increase
in positive food contact surface testing results as a result of the
proposed regulation changes. FSIS estimates that eighty-five percent
\20\ (1,258) of the establishments will incur no costs, because
these establishments already have taken steps to remediate problems
with L. monocytogenes contamination in product. However, it is
possible that these establishments may have future problems with
environmental contamination by Listeria spp. So, FSIS may have
overestimated the number of establishments that will incur no future
costs as a result of the proposed requirements.
---------------------------------------------------------------------------
\19\ Guidelines to Prevent Post-Processing Contamination from
LM, 1999.
\20\ Further data analysis is needed to more accurately estimate
this figure. The current estimate is based on MARCIS data on follow-
up LM positive finding for only one year of data (1999). This first
group of producers are assumed to represent the 85 percent of
initial positive microbiological survey samples that quickly
rectified their contamination problems in 1999. The latter stages
reflect smaller and smaller percentages of the initial positive
samples that required more and more follow-up tests because their
test results persisted positive.
Table 12.--Number of Establishments and Associated Costs of Potential Production Adjustments With Respect to
Mandatory LM Testing
----------------------------------------------------------------------------------------------------------------
Problem category (by # of establishments) Associated
Representative --------------------------------------------- cost to Value of
Group/subgroup meat and poultry Stage control LM discontinued
products None --------------------------- Total problem production on
1 2 3 (000's $) (mil $)
----------------------------------------------------------------------------------------------------------------
I-1.............. Fermented; 127 11 11 1 150 181.6 1 5.9
Dried; and,
Salt cured
Products.
I-2.............. Frankfurters and 142 12 12 1 167 248.1 23.6
wieners.
I-3.............. Meat patties.... 65 5 5 1 76 72.5 5.3
I-4.............. Luncheon meats.. 163 13 13 2 191 519.0 60.5
II-1............. Otherwise 468 39 39 5 551 597.7 48.8
processed M&P
RTE product by
meat processors.
II-2............. Otherwise 139 12 12 1 164 570.4 66.9
processed M&P
RTE product by
poultry
processors.
II-3............. Otherwise 65 5 5 1 76 99.3 9.6
processed M&P
RTE product by
combo plants.
III.............. Frozen dinners 89 7 7 1 104 201.9 21.6
and pizzas.
IV............... Canned products. 0 0 0 0 0 0 0
----------------------------------------------------------------------------------------------
Grand total.... ................ 1258 104 104 13 1479 2490.5 252.2
----------------------------------------------------------------------------------------------------------------
Some establishments follow the recommended guidelines in
production but, for any number of reasons, are expected to face
difficulties in improving their L. monocytogenes testing results.
Establishments that encounter Stage 1 problems would face only
marginal difficulties in improving their Listeria spp. testing
results. Seven percent of the establishments (104) are expected to
fall into a this group. FSIS expects that these plants can reduce
these positive findings by concentrating mainly on the pre-
operational component of the business,\21\ perhaps taking more care
in pre-operational sanitation and better training of and increased
awareness by production personnel. Also, one could expect that some
``quick-fixes'' to equipment, such as finding the niches in
equipment which may harbor L. monocytogenes and cleaning them
thoroughly and more regularly, might greatly reduce their positive
food contact surface testing results. Actions that are expected
correspond roughly to the response by industry in a recent survey
pertaining to what actions are taken by establishments when they
exceed limits on results from environmental testing. These include:
---------------------------------------------------------------------------
\21\ Some increase in sanitation supplies and materials are also
expected.
---------------------------------------------------------------------------
Enhance pre-operational and operational sanitation
controls in production (262 out of 308 establishments that responded
to the industry survey cited previously indicated that this action
was taken when allowable environmental testing results were
exceeded);
Implement an environmental monitoring program for
Listeria spp. to verify that the control program is effective (241
out of 302 surveyed indicated that this action was taken when
allowable environmental testing results were exceeded);
Intensify training efforts on personnel (232 out of 302
surveyed indicated that this action was taken when allowable
environmental testing results were exceeded);
Purchase inputs from suppliers with a L. monocytogenes
control program, and;
Apply a validated listericidal process where
appropriate.
FSIS expects that plants encountering Stage 1-type problems will
face a $2000 per line average ``fix'' for equipment and machinery.
These efforts are expected to be effective and not involve any
recurring cost. Across all affected establishments, such costs are
expected to total $0.7 million.
An additional 7-percent of all establishments (104) are expected
to face significantly greater difficulty in improving their food
contact surface Listeria spp. testing results: ``Stage 2-type''
problems that can not be solved simply by increased attention to
pre-operational sanitation efforts. These plants must instead
concentrate on equipment and building re-design and other manageable
``technical fixes''. By their nature, these one-time efforts are
more costly. Examples of the kind of efforts envisioned with these
adjustments are: addition of post-processing pasteurization
equipment, re-designed drains, walls, and floor areas, especially in
the post-processing rooms, and other major renovations to buildings
and equipment.\22\
---------------------------------------------------------------------------
\22\ Further examples can be found in: Industry Perspectives on
LM in Foods: Manufacturing and Processing, Bernard and Sveum, Dairy,
Food and Environmental Sanitation, Vol. 14, No. 3, Pages 140-143
(March 1994).
---------------------------------------------------------------------------
FSIS expects that plants encountering Stage-2 type problems will
face higher costs than establishments facing Stage-1 problems. Based
on expenses incurred by the industry in taking similar steps in the
early 1990's, FSIS estimates that such efforts could cost the
affected establishments 0.1 percent of their gross sales.\23\ Some
product losses from these firms are expected due to greater amounts
of product held from commercial channels because of positive food
contact surface tests for Listeria spp. or positive product test
results for L. monocytogenes.\24\ Such product losses are expected
to diminish after 6 months. Thus, such temporary production drops
and possible disruptions are not considered throughout this
analysis. FSIS request comment on the costs of holding and testing
product for L. monocytogenes contamination. Keeping this in mind,
FSIS projects that the total expenses
[[Page 12632]]
associated with Stage 2 corrective actions across the industry at
$1.7 million. In total, corrective actions associated for both Stage
1 and 2 type problems are expected to cost $2.5 million in one-time
costs.
---------------------------------------------------------------------------
\23\ Tappero, Jordan, Anne Schuchat, Katherine Deaver, Laurene
Mascola and Jay Wanger, Reduction in the Incidence of Human
Listeriosis in the United States, Effectiveness of Preventive
Efforts?, JAMA, April 12, 1995--Vol. 273, No. 14. This study
actually put the costs at the range of 0.1 to 0.2 of annual industry
sales.
\24\ It is also acknowledged that increased numbers of positive
environmental tests may result in increased numbers of positive
product tests, leading in turn, to not only increased amount of
product destroyed, but increased amounts of product that need to be
held until results are complete and in the case of positives,
increased amount of products that need to be reworked.
---------------------------------------------------------------------------
A final group of plants is expected to face Stage 3-type
problems: problems that establishments may perceive to be
prohibitively costly to ``fix'' and/or not feasible to undertake
without complete modernization or renovation. Without making the
needed capital investments, their only option is to drop out of
production. This may involve dropping just the RTE meat and poultry
product component of their business or eliminating RTE meat and
poultry products altogether.\25\ FSIS estimates that one percent of
all establishments (13) regardless of size category \26\ will fall
into this category. Resources, associated with the associated
discontinued production, are expected to be absorbed by their next-
best use, such as frozen not-RTE food and other food manufacturing.
The value of the initial drop in production across the industry is
estimated at $252 million. Although firm numbers may drop by 1-
percent, this initial drop in production would not be expected
persist over time. Market supplies would be expected to increase due
to likely production increases by the remaining domestic
establishments and possibly by increased imports of similar type
meat and poultry products.
---------------------------------------------------------------------------
\25\ It is misleading to attribute all of the reason for the one
percent decline in firm numbers on the proposed rule. Some number of
firms would have gone out of production due to competitive reasons
and dynamics involved in industry technological change. Regardless
of the regulatory environment, some level of technology will be
adopted by some firms and not by others; in addition, technology may
be made available to control LM in RTE food processing during the
time frame of this analysis. If this technology is size-neutral,
projections concerning industry response to the proposed regulation
is problematic. On an optimistic note, impacts may be dampened
considerably by such technology adoption. Examples of technology
that is being developed (and may be scale-neutral) include:
antimicrobial packaging, high pressure processing, irradiation,
oscillating magnetic fields, pulsed electric fields, and UV light
(Meat and Poultry, April 2000, Post-processing pasteurization,
Preventing recontamination requires an aseptic approach). However,
impacts may be greater if technology does not advance and Listeria
control is more of a function of pre-operational perquisites, like
building re-design and layout. Due to the great amount of
uncertainty related to this issue, no assumptions were made
concerning these off-setting influences. However, the one-percent
level was used to indicate that some number of plants may drop out
of production as a result of the proposed rule.
\26\ Given time, further analysis may reveal that the
probability of such Positive Microbiological Survey Finding's are
associated with certain Meat and poultry products, plant age or
size, or other major characteristic(s), i.e. season. Recall and
other internal FSIS data were investigated and no single
characteristic was found to explain MPSF occurrence and/or
frequency.
---------------------------------------------------------------------------
FSIS realizes that many of the technological ``fixes'' that many
establishments may have to undertake are not scale-neutral (they
favor increasing scale establishments). Thus, one may discover that
small and very small establishments are disproportionately affected
by this provision of the proposed rule. However, to ensure maximum
food safety benefits from testing, FSIS is proposing to require
industry-wide adoption. FSIS requests comments on expected impacts
on small and very small establishments.
The total cost of mandatory food contact surface testing on this
industry is estimated at $5.53 million ($1.28 million on HACCP plan
modification, $1.75 million on testing, and $2.5 million in
production adjustment costs).
2. Costs Associated With Lethality and Stabilization Performance
Standards
This provision, as described in the provisions section, mirrors
the recently published performance standards for the production of
cooked beef, roast beef, cooked corned beef products, fully and
partially cooked poultry products (64 FR 732). However, that rule
did not apply to dried, fermented, and salt-cured RTE meat and
poultry products. Fermented sausage makers were advised in the mid-
1990's on methods to ensure food safety and most of these processors
made changes to their production at that time; however, this is not
known for sure. Also, the current proposed rule would increase the
required level of pathogen reduction in meat patties. As such,
processors of meat patties and the dried, fermented, and salt-cured
RTE meat and poultry products are expected to feel the major impact
from this provision of the proposed rule. FSIS expects that this
provision may have two potential impacts on certain RTE meat and
poultry product producers: (1) the need to make production changes
to attain the higher performance standards and (2) the need to
incorporate increased monitoring equipment and other means to
validate that they are meeting the new performance standards.
A. Projected Costs Associated With Production Adjustments
The majority of the establishments that produce RTE meat and
poultry products are not expected to be affected by the lethality
and stabilization provisions of the proposed rule. Most
establishments already may meet these requirements because they are
identical to those in the final rule that established performance
standards for the production of certain RTE meat and poultry
products (64 FR 732). However, it is expected that one-third of the
plants in Group I, Subgroup 1 (Dried, Salt-cured and Fermented
Sausage makers) and one-third of Group I, Subgroup 3 (meat patty
makers) will be affected by this provision of the proposed rule.
FSIS estimates that these 75 establishments or less than 5 percent
of the establishments in this industry produce about 441 million
pounds of product.\27\
---------------------------------------------------------------------------
\27\ Using an assumed average level of production for each
establishment of 50, 5, and 2 million pounds for large, small, and
very small establishments, respectively, in each affected sub-group
times the number of affected establishments.
---------------------------------------------------------------------------
FSIS expects that producers will adjust to higher performance
standards by applying some additional heating or holding times to
their products or by relying upon integrated lethality involving
multiple hurdles or accounting for come-up and come-down time. FSIS
tentatively concludes that many establishments would meet the
proposed performance standards using current procedures; however,
the integrated cumulative lethality of these procedures may not have
been fully assessed at this time. Individual establishments' costs
could vary greatly depending on their need to purchase capital
equipment, such as flash freezers for quicker cooling times, new
heating equipment, etc., that may lead to increased costs in the
short run, but lower operating costs and improved product in the
long run. FSIS expects that most establishments will continue to
produce their products in much the same way, but may increase their
heating temperatures and holding times. In so doing, they are
expected to experience somewhat reduced production line speeds,
initially higher product rejection rates, and slightly lower annual
production.\28\
---------------------------------------------------------------------------
\28\ These implicit costs are associated with production drag--
increased levels of recalls, higher rejection rates in production,
slower production shifts, slower sales due to perceived poorer
quality and such. Ideally they should be counted as a separate
effect associated with a possible leftward shift in supply. At this
time, there is not sufficient data to quantify this effect.
---------------------------------------------------------------------------
FSIS has only limited data to base its estimate for the impact
of higher performance standard. Some anecdotal information suggests
that some establishments, to attain the new lethality performance
standards, may have to incur an additional cent per pound of product
produced. This estimate implicitly incorporates the cost of reduced
annual sales by the firm due to slower line speeds (and its implicit
effect on lost value of production), equipment costs, and higher
energy costs. At this time, this one-cent per pound cost is used in
this analysis. FSIS uses this per-pound estimate and its estimate on
affected poundage of product to project an aggregate annual
recurring cost of $4.4 million ($0.01 times 441.1 million pounds).
B. Projected Cost Associated With Performance Standard Validation
The 75 establishments identified above are expected to need a
one-time validation to determine if they are meeting the higher
performance standards. FSIS estimates that these firms produce, at
least, 545 specific product-types that would need lethality and
stabilization validation. FSIS expects that the costs to validate
the attainment of performance standards to be the same as the
validation of a HACCP plan modification ($5000). Thus, FSIS
estimates that the over-all cost to establishments to validate that
they are attaining the higher performance standards for these
products at $2.7 million (545 times $5000).
Projected Costs Associated With Label Changes. FSIS is proposing
that the labeling of RTE products state that the product requires
refrigeration after opening, as applicable. Current regulations
require that labels of perishable products include such
instructions, but the Agency is proposing to expand the required
label instructions to include RTE shelf-stable products that require
refrigeration after opening. For
[[Page 12633]]
products that would be covered by this provision, FSIS estimates
that the costs per label would be comparable to those for printing
safe handling labels ($0.0025 to $0.05 per label if the information
is included as part of their price label, and, $0.01 per label if
they developed separate labels) (see 58 FR 58924). FSIS requests
comment on the costs and benefits of this labeling provision.
Projected Benefits From the Proposed Rule
All the benefits from this proposed rule are generated by
producers' actions complying with the mandatory food contact surface
Listeria testing and the HACCP plan provisions of the proposed
rule.\29\
---------------------------------------------------------------------------
\29\ Recall that the benefits from producers complying with the
higher performance standards are not quantified at this time. Also,
refer to the uncertainty discussion for an explanation of factors
that may lead to underestimation problems.
---------------------------------------------------------------------------
Benefits are expected to accrue gradually over time. Although
studies found in the literature suggests that L. monocytogenes
control measures take about 6 months to 2 years before they are
successful, FSIS found no basis for what form this time path for
benefits should take. However, FSIS wants to account for any lag in
the effectiveness of producer actions and other factors that may
affect the immediate realization of full benefits. FSIS uses the
following time path for realization of benefits: 5% realization by
the first year; 10%, by the second year; 15%, by the third year;
40%, by the fourth year; 50%, by the fifth year; 60%, by the sixth
year; 70%, by the seventh year; 80%, by the eighth year; 90%, by the
ninth year; and, 100% by year ten. FSIS requests comment and
information regarding the realization of projected benefits.
Benefits are predicated on a chain of events: the proposed rule
testing requirements motivating establishments to maintain higher
sanitation standards; the introduction of less contaminated product
in commercial channels; and eventually, fewer listeriosis cases and
deaths from the consumption of RTE meat and poultry products.
Mandatory environmental food contact surface testing forces
producers to incur costs to recognize (and, if need be, to remedy)
their contamination problems. These costs, and those related to
performance standards, are made up of mostly one-time, first-year
costs and low recurring annual costs. More than half (56 percent) is
related to performance standards, not mandatory testing (44
percent). Still, FSIS expects that the benefits derived from
mandatory testing results would exceed the costs of both provisions.
Table 13.--Nominal and Real Costs of the Proposed RTE Rule and Associated Listeriosis Case Reductions at 100
Percent Effectiveness--All RTE Meat and Poultry Products
----------------------------------------------------------------------------------------------------------------
Cases eliminated
-------------------------------
Year Nominal cost Real cost ($ FDA-FSIS
($ million) million) draft risk Mead-Olsen
assessment studies
----------------------------------------------------------------------------------------------------------------
1............................................... 12.6 11.8 83 8.35
2............................................... 6.2 5.4 166 16.7
3............................................... 6.2 5.0 249 25.05
4............................................... 6.2 4.7 664 66.8
5............................................... 6.2 4.4 830 83.5
6............................................... 6.2 4.1 996 100.2
7............................................... 6.2 3.8 1162 116.9
8............................................... 6.2 3.6 1328 133.6
9............................................... 6.2 3.3 1494 150.3
10.............................................. 6.2 3.1 1160 167
---------------------------------------------------------------
Total....................................... 68.1 49.3 8632 868.4
----------------------------------------------------------------------------------------------------------------
\1\ The year-end discount rate used is 7.0 (OMB, Circular No. A-94, updated January 2000).
Alternatives
Executive Order 12866 requires that FSIS identify and assess
alternative forms of regulation. FSIS considered one alternative to
all of the proposed regulations and five alternatives to the
proposed testing requirements. These are discussed below.
1. No Action
The Agency considered not requiring the proposed performance
standards for RTE meat and poultry products. Small and very small
establishments may incur most of the costs of the proposed extension
of the existing performance standards to all RTE meat and poultry
products. There are currently performance standards for certain not-
shelf-stable RTE meat and poultry products (RTE roast beef, corned
beef, all ``fully-cooked'' RTE poultry products, and partially-
cooked meat patty and poultry products). However, there currently
are no performance standards specific to jerky, meat hotdogs, and
luncheon meat and the current requirements for meat patties effect a
lethality less stringent than that which is proposed.
FSIS considered not proposing to extend the performance
standards to these products because of the possible disproportionate
economic impact on small business. However, taking this alternative
would result in a significant inconsistency in the Agency's public
health policy. Most, if not all, RTE meat and poultry products are
manufactured from the same supply of raw product examined in the
FSIS national baseline surveys. So, performance standards derived
from this baseline should be applicable to all categories of RTE
meat and poultry products, regardless of how they are processed. All
RTE products should be required to meet the same standard of safety.
FSIS will publish compliance guides and possibly take other actions
to mitigate the economic effects of any final rule on small
businesses.
In general, some members of the meat and poultry industry
believe that regulatory performance standards are unnecessary or
redundant, considering that FSIS already requires all meat and
poultry establishments to develop and implement HACCP systems. FSIS
believes, however, that developing HACCP systems around verifiable,
objective performance standards is the most effective way for
establishments to consistently produce safe, unadulterated meat and
poultry products. Furthermore, by proposing performance standards
for pathogens whose destruction results in the destruction of most
or all other pathogens of concern, FSIS provides a reference for
establishments to use in gauging the efficacy of their HACCP
systems. FSIS, therefore, is proposing pathogen reduction
performance standards that can be incorporated into HACCP systems,
rather than requiring that establishments rely upon HACCP alone.
FSIS considered not revising the prescriptive canning and
trichina treatment requirements for certain pork products. However,
these provisions of the proposed regulations represent regulatory
reform and streamlining efforts. The regulatory safety standards for
commercially sterile products and for pork products would be
unaffected by this proposal. FSIS also considered not requiring
testing for Listeria. However, without some regulatory requirements
addressing Listeria, many establishments will continue not to regard
L. monocytogenes as a post-lethality hazard reasonably likely to
occur and not take steps through Sanitation SOPs or HACCP to ensure
the safety of their products. FSIS tentatively concludes that
[[Page 12634]]
without defining required actions in either the Sanitation SOPs or
HACCP, product will continue to test positive for L. monocytogenes
and outbreaks will continue to occur.
2. End-Product Testing
FSIS considered proposing to require testing of finished product
for L. monocytogenes instead of the proposed food contact surface
testing for Listeria spp. In short, FSIS does not believe that such
end-product testing at levels high enough to ensure statistical
confidence would be a practical means of ensuring that RTE meat and
poultry products are not adulterated by L. monocytogenes. To
determine that every lot of RTE product was not adulterated by L.
monocytogenes, an establishment would likely have to test a
significant portion of each lot and hold each lot until test results
were confirmed.
Further, end-product testing to verify process control is
antithetical to the notion of process control under the Agency's
HACCP and Sanitation SOP regulations. Granted, FSIS is proposing to
require product be held and tested in the event an establishment has
a positive food-contact surface test result. But this proposed
product testing is a measure every prudent establishment should take
when it determines that its Sanitation SOP is ineffective and that
product may have been produced under insanitary conditions and
therefore may be adulterated. FSIS believes, based on the numerous
recalls involving small quantities of RTE meat and poultry products
and the fact that the majority of the recalls are initiated in small
and very small establishments, that members of the meat and poultry
product industry are not effectively ensuring that products are not
adulterated. Thus, the Agency, in the interest of public health,
opted to propose making mandatory food-contact surface testing for
Listeria spp.
3. Mandatory Post-Lethality Interventions for L. monocytogenes
FSIS is aware of several establishments that currently apply a
post-lethality steam pasteurization treatment to their RTE products,
specifically to eliminate L. monocytogenes. FSIS allowed
establishments to use antimicrobials specifically effective in
preventing growth of L. monocytogenes in RTE products (i.e., sodium
diacetate, potassium lactate, and sodium lactate, 65 FR 17128, March
31, 2000). Furthermore, in the future, other types of antimicrobial
interventions that can be applied after lethality treatment and
after packaging that can eliminate L. monocytogenes from RTE
products may be available. For example, eventually, FDA and FSIS may
allow establishments to treat RTE products with ionizing radiation.
If applied within a HACCP system, irradiation could eliminate L.
monocytogenes from a RTE product. FSIS also is aware that industry
is developing edible, antimicrobial coatings that could be applied
to RTE meat and poultry after cooking or other lethality treatments.
However, FDA has not yet approved any of these coatings for meat and
poultry.
FSIS considered requiring establishments to implement post-
lethality antimicrobial controls instead of testing food contact
surfaces for L. monocytogenes. Obviously, however, since most of the
needed technologies are not yet available or not yet approved,
establishments would have a limited number of treatments to choose
from and some may not be appropriate or useable in every processing
system. Further, mandating the use of any specific technology would
be counter the Agency's goal of granting establishments maximum
flexibility to innovate and design customized processes capable of
producing safe meat and poultry products. And, initially, many of
these new technologies may be prohibitively expensive as they become
available, especially for small businesses.
By proposing to exempt establishment with CCPs for L.
monocytogenes from the required testing, FSIS is providing an
incentive for establishments to implement these new technologies as
they become available. Also, the proposed exemption will allow
establishments to conduct testing instead of developing HACCP plan
controls, if they find testing to be a more cost-effective means of
preventing contamination of the their RTE products by L.
monocytogenes as result of insanitation.
4. Mandatory Food Contact Surface Testing for All Establishments
That Produce RTE Products
Because L. monocytogenes is an environmental contaminant and
often adulterates RTE products as a result of insanitation, FSIS
considered requiring all establishments that produce RTE meat and
poultry products to test for Listeria spp. as a way to verify plant
sanitation, regardless of whether they have implemented HACCP
controls for L. monocytogenes. However, if an establishment develops
a new CCP or designates an existing CCP to control contamination of
its products by L. monocytogenes, it will be taking process control
actions that likely will include sanitation practices to limit
levels of L. monocytogenes on incoming raw product, lethality steps
to destroy L. monocytogenes, sanitation control steps to prevent
recontamination, or testing to validate and then frequently verify
that its controls are effective. FSIS believes that requiring these
establishments to also conduct the mandatory testing for Listeria
spp. would be unnecessary and redundant. Further, requiring all
establishments that produce RTE products to conduct testing for
Listeria spp. is expected to increase annual compliance costs from
the estimated $1.75 million in testing costs related to the specific
provisions in the proposed rule to $4.6 million. Again, these costs
should be regarded as direct annual recurring costs associated with
the minimum number of food contact surface testing estimated by
FSIS.
5. Redesignation of Hotdogs and Other Products as Not-Ready-To-Eat
FSIS considered creating a new category of products for
partially-cooked sausages and other products that no longer would be
considered RTE. An establishment that redesignated its meat and
poultry product as not RTE would not be required to conduct the
proposed testing for Listeria spp. nor meet any other regulatory
requirements applicable only to RTE products. FSIS would require the
establishment, however, to label its not RTE product with the safe
handling instruction (9 CFR 317.2(l), 381.125(b)) and with cooking
instructions similar to that for partially-cooked meat patties and
poultry rolls (9 CFR 318.23 and 381.150).
The safe handling instruction is required for all products that
have not undergone processing that would render them RTE and
includes four labeling statements, including ``cook thoroughly''
along with a graphic illustration of a skillet. The cooking
instruction is currently required for partially-cooked meat patties
and poultry rolls, which need thorough cooking prior to consumption
for safety. This cooking instruction states: ``Partially-cooked: For
Safety Cook until Well Done (Internal Meat Temperature of 160
degrees Fahrenheit)'.
FSIS considers cooked meats, including those defined in 9 CFR
319.180 (Subpart G--Cooked Sausage) which include frankfurters,
hotdogs, wieners, bologna, and similar products, to be RTE products.
Ready-to-eat products should be safe to consume without any
additional cooking or application of a lethality treatment by the
consumer. More importantly, it is likely that most consumers also
consider hotdogs and similar products to be RTE, and only apply a
heat treatment to improve product palatability. Consumer behavior
would have to be significantly modified to ensure that they are
aware that an adequate cook for safety must be applied to these
products.
Another consideration is that restaurants, including street
vendors and quick-service operations, would have to treat these
redesignated products as not-RTE. The current Model Food Code
provides that RTE food taken from a commercially-processed intact
package from a food processing plant shall be heated to a
temperature of at least 140 degrees Fahrenheit for hot holding (FDA
Food Code, section 3-403.11). The hot holding temperature is not
intended to serve as the lethality treatment for the product, but
only as a temperature sufficient to prevent multiplication of
pathogens while the product is being held prior to sale. Thus, this
industry would have to apply a higher minimum temperature and time
combination to achieve the necessary lethality for safety.
FSIS does not have the data needed to estimate the costs that
would result from the redesignation of certain hotdogs and similar
products as not-RTE. Direct costs to industry would include: new
labeling; the cost to retailers who be required to apply higher
time/temperature combinations to the redesignated products; and
possible loss of market share by firms that redesignate their
products as not-RTE to firms that continue to produce RTE products.
Other costs include consumer education and, most importantly,
possible public heath costs resulting from consumers inadequately
cooking not-RTE products traditionally considered RTE and
consequently contracting foodborne illnesses. It is likely that
these costs would exceed the savings that industry would accrue from
being exempted from the proposed testing requirements and other
requirements
[[Page 12635]]
applicable to RTE products and FSIS has therefore rejected this
alternative. FSIS does request comment, however, on these and
related issues.
6. Require ``Use-By'' Date Labels on Certain RTE Meat and Poultry
Products
FSIS considered, but is not proposing, requiring that the
labeling of certain RTE meat and poultry products state the
product's shelf-life, and that shelf-life be based on product safety
(``use-by'' date labeling) in addition to the proposed L.
monocytogenes control measures. L. monocytogenes contamination is
often a result of product manipulation, such as the slicing of deli
meats or the peeling of hotdogs, after lethality treatments are
applied. In the recent interagency draft risk assessment, FDA and
FSIS have concluded that numerous RTE meat and poultry products that
undergo post-lethality manipulation and that can support the growth
of L. monocytogenes in their final packaging and under refrigerated
conditions are at relatively higher risk of causing listeriosis.
Food contact surface testing does not address (1) the physical
inability of current testing devices to detect minuscule amounts of
L. monocytogenes in some finished RTE meat and poultry products
after their manufacture and (2) the capability of L. monocytogenes
to grow-out in certain products, even while being kept under
refrigerated temperatures. Thus, process controls and food contact
surface testing may not reduce risk sufficiently. Some small amounts
of product, with non-detectable L. monocytogenes contamination
levels, could continue to enter commercial food channels. Also,
consumers may be improperly handling certain products. The main meat
and poultry products of concern are deli meats and frankfurters--
products which receive post-processing handling and manipulation and
have been associated with past listeriosis outbreaks.\30\ If
consumers understood ``use-by'' dates and changed their behavior
accordingly, ``use-by'' labels could help to ensure food safety
through proper handling of RTE meat and poultry products and thereby
reduce the risk of listeriosis. However, it is likely that consumer
behavior would have to be significantly modified to ensure that they
are understand ``use-by'' dating.
---------------------------------------------------------------------------
\30\ Up to 92 percent of all listeriosis cases and deaths from
RTE meat and poultry products, as calculated by FDA-FSIS RA, was
attributable to the consumption of deli meats and frankfurters.
---------------------------------------------------------------------------
For most consumers who are healthy and safely handle their food,
this low level of possible L. monocytogenes contamination does not
pose a significant food safety hazard. However, this is not the case
for high-risk individuals who may be severely harmed by L.
monocytogenes, even by slightly contaminated RTE meat and poultry
products. Increased mandatory food contact surface testing should
reduce the likelihood of any L. monocytogenes contamination present
in these products.
In the process, producers and marketers will likely alter their
behavior with respect to product rotation in storage and marketing.
There is sparse information regarding the potential affects of this
labeling, the likelihood that consumer practices will change, and on
the effect of changes in consumer behavior on listeriosis cases.
Similarly, FSIS currently does not possess all the information
necessary to assess the reduction in risk that will occur from this
change. Also, the ``use-by'' date labeling may give consumers a
false sense of security.
Much uncertainty surrounds the potential costs and benefits of
``use-by'' dating. Little research has been done to address many
issues regarding this alternative. For instance, what is the likely
consumer reaction to ``use-by'' date labeling? What are the public
health consequences? How would ``use-by'' date labeling potentially
impact the production and shipment patterns of labeled RTE meat and
poultry products and the structure of the industry? For example,
will smaller operations benefit from a ``use-by'' date more than
larger operations who must rely on larger sales areas which require
longer product shelf life to penetrate the entire marketing area?
Further, much uncertainty surrounds expectations for increased
consumer awareness by the high-risk sub-population of ``use-by''
date labeling. Assuming the awareness rates for the high-risk sub-
population were the same as the general population, only 12.4 fewer
annual listeriosis deaths would result from ``use-by'' dating (as
opposed to 54).
Comment Request
FSIS requests comment on the feasibility of requiring ``use-by''
date labeling on certain RTE meat and poultry products, generally in
regard to the public health benefits and the costs of such labeling,
and specifically in regard to the following questions:
(1) What would be the most effective way to implement an ``use-
by'' labeling scheme? Should FSIS propose to require that use-by
dates be determined and validated within the producing
establishment's HACCP plan? Or, should another alternative be used.
(2) What assumptions should be used about retailer and consumer
behavior in determining a use-by date? Should the use-by date be
determined under the assumption that retailers and consumers will
follow any handling instructions contained in the labeling? Or,
should the use-by date determination be based on a ``worst case''
assumption that products will be mishandled or temperature abused?
(3) What scientific and economic data are available regarding
the shelf-life and safety of RTE meat and poultry products
contaminated with L. monocytogenes? Are any studies of ``use-by''
date labeling efficacy available? FSIS is currently working with the
Agricultural Research Service on a study to evaluate the shelf-life
of hotdogs and is aware of other studies, but welcomes any
additional information. FSIS would publish guidance regarding use-by
dating before any final action becomes effective and would base this
guidance on the latest science available.
(4) Should FSIS propose to require post-lethality L.
monocytogenes interventions instead of ``use-by'' date labeling?
FSIS is aware that in the future, certain types of antimicrobial
interventions that can be applied after lethality treatment but
before packaging and that can eliminate L. monocytogenes from RTE
products may be available. Eventually, FDA and FSIS may allow
establishments to treat RTE products with ionizing radiation. If
applied within a HACCP system, irradiation could eliminate L.
monocytogenes from a RTE product. FSIS also is aware that industry
is developing edible, antimicrobial coatings that could be applied
to RTE meat and poultry after cooking or other lethality treatments.
However, FDA has not yet approved any of these coatings for meat and
poultry.
(5) What language would be most effective in informing consumers
about ``use-by'' date labels? Would labeling such as ``For safety,
use-by * * *'' be more effective? Should the labeling indicate
anything regarding vulnerable populations? Should FSIS propose to
allow for a variety of phrases? FSIS is aware that many RTE meat and
poultry products already carry shelf-life labeling indicative of
product quality. Would allowing different phrases result in consumer
confusion? Would allowing quality and safety dates to appear on the
same package result in confusion? Should FSIS propose to allow
different dates based on handling instructions, for instance: one
date if the consumer freezes the product, another if the consumer
refrigerates the product?
Uncertainty
Benefits Side
The current level of benefits does not consider what technical
obstacles exist that may reduce the effectiveness of the provisions
in the proposed rule to actually reduce listeriosis cases and
deaths. FSIS is uncertain about the effectiveness of its proposed
testing requirements in reducing listeriosis, and therefore unable
to adequately quantify a range of benefits. No research that
directly looked into this subject was found in the literature. FSIS
intends to use comments and data received during the comment period
and at the planned technical conference to refine the proposed
regulations and to better estimate benefits. It is of course
unlikely that the proposed regulations could achieve complete
elimination of the listeriosis that results from contaminated meat
and poultry, but FSIS believes that the benefits of the regulations
would exceed the total costs of all of the proposed provisions. The
current baseline analysis does not consider any private sector
benefits that may result from the proposed rule. The impact of fewer
recalls, possibly smaller amounts of returned product with better
labeling, fewer consumer complaints, and other reduced costs may
benefit the establishments that thrive in the new regulatory
environment.
The benefits in this analysis are calculated as if they accrue
gradually over time. More research into this subject is needed.
Although some research has shown that it would take six to eighteen
months for industry LM-control efforts to show positive results,
little research was found that looked into the time path for
benefits.
Unquantified Benefits Resulting From Proposed Performance Standards
There are currently no performance standards specific to jerky,
meat hotdogs, and
[[Page 12636]]
luncheon meat and the current requirements for meat patties effect a
lethality less stringent than that which is proposed. Fermented
sausage makers were advised in the mid-1990's on methods to ensure
food safety and most of these processors made changes to their
production at that time; however, this is not known for sure. As
such, processors of meat patties and the dried, fermented, and salt-
cured RTE meat and poultry products are expected to feel the major
impact from the proposed rule. However, little is known about the
production process for many dried and fermented products affected by
this rule.
According to one study, E. coli O157:H7 causes 52 foodborne-
related deaths per year. Nontyphoidal Salmonella causes 582
foodborne-related deaths per year (Mead, 1999). Some benefits are
expected to be generated by fewer sicknesses due to the proposed
Salmonella and E. coli O157:H7 performance standards that would be
extended to certain RTE meat and poultry products that are not
currently required to meet these performance standards. However,
FSIS has not conducted a quantitative analysis of these benefits and
requests comments and data on possible benefits resulting from the
proposed requirements.
FSIS is replacing prescriptive provisions concerning thermally
processed, commercially sterile meat and poultry products with
performance standards. The proposed performance standards will
ensure that this product continues to be safe. FSIS believes these
proposed provisions would not impose any costs because producers
could continue to follow the same procedures required under the
current regulations. Producers may realize some benefit from the
flexibility that will be allowed under the performance standard
regulations if they adopt new innovative means of producing the
product. However, FSIS could not estimate any benefits that may be
derived from replacing these prescriptive provisions with
performance standards and requests comment on possible benefits that
may be realized.
FSIS is proposing to eliminate its regulations that require both
RTE and not-ready-to-eat pork and products containing pork be
treated to destroy trichinae (Trichinella spiralis). FSIS believes
that, even if these provisions are removed, pork products will
continue to be safe from trichinae. For heat-treated, RTE products
containing pork, the required treatment to destroy trichinae would
no longer be needed because if the process used meets the proposed
performance standards for Salmonella, the process should eliminate
any live trichinae. For other products, if the establishment
identifies trichina as a hazard reasonably likely to occur, the
establishment would have to ensure that the process used effectively
eliminates this hazard. If the prescriptive provisions concerning
trichinae are removed from the regulations, producers may realize
benefits if they determine trichina is not a hazard reasonably
likely to occur or if they find new ways of treating their product
for trichinae.
Cost Side
Over eighteen percent of the first 10 years' total cost of the
proposed rule occurs in the first year of program implementation.
These costs take the form of one-time outlays related to validation
of (1) modifications to HACCP plans and (2) attainment of
performance standards. FSIS anticipates that expected industry costs
resulting from this proposed rule could be lowered substantially
with assistance to deal with these one-time costs.
There may be some consumer welfare losses that result from lower
production that may result from this proposed rule. Because some
firms may lose market share for their RTE meat and poultry products,
consumers may be provided with fewer RTE meat and poultry products
in total and a more limited choice among RTE meat and poultry
products. Comments are welcome concerning the extent to which this
proposed rule may affect the range of RTE meat and poultry products
and other issues dealing with consumer choice.
The analysis of the costs associated with performance standards
noted that the cost estimate used is highly uncertain, being based
on information gathered in a pilot survey. An industry survey is
underway and hopefully will address much of the uncertainty of
production processes currently employed by producers of these
products and their options when faced with higher performance
standards. FSIS based the analysis on performance standards on very
limited data, much of it received as part of a pilot survey. FSIS
requests information concerning the production process for many of
these dried and fermented products affected and the options that
producers have in dealing with this provision.
Much uncertainty involves the break down of these results by
size of establishment. As noted in this analysis and the Regulatory
Flexibility Act section, an argument can be made that the proposed
rule will disproportionately affect small entities. However, to the
extent that validation costs (which can be considered more like
fixed costs rather than variable costs) can be reduced, this effect
will be minimized. Without these reductions, however, validation
costs would tend to disproportionately affect small producers rather
than large ones. Any research and assistance to make these needed
validations and production adjustments as scale-neutral as possible
could dampen the possible disproportionate impact on small entities.
Mandatory food contact surface testing could impose a need to
build additional storage for suspected contaminated products to wait
in a ``test and hold'' period. This may affect smaller operations
more than larger ones. FSIS requests comments that address this
issue.
[FR Doc. 01-4420 Filed 2-26-01; 8:45 am]
BILLING CODE 3410-DM-P