[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
------------------------------------------------------------------------
 
------------------------------------------------------------------------
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.

[[Page 12592]]

 
                                         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.
------------------------------------------------------------------------

    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

[[Page 12593]]

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:

------------------------------------------------------------------------
 >0 surviving   >1 surviving   >2 surviving   >3 surviving  >4 surviving
------------------------------------------------------------------------
        39.4           9.06           1.45          0.177        0.0174
------------------------------------------------------------------------

    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
------------------------------------------------------------------------
            >0 surviving                         >1 surviving
------------------------------------------------------------------------
                   22.2                                 2.67
------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \1\ http://www.fsis.usda.gov /OPPDE/rdad/FRPubs/95- 
033F_tech%20paper.pdf
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \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