[Federal Register Volume 68, Number 109 (Friday, June 6, 2003)]
[Rules and Regulations]
[Pages 34208-34254]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-14173]



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Part V





Department of Agriculture





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Food Safety and Inspection Service



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9 CFR Part 430



Control of Listeria monocytogenes in Ready-to-Eat Meat and Poultry 
Products; Final Rule

  Federal Register / Vol. 68, No. 109 / Friday, June 6, 2003 / Rules 
and Regulations  

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DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Part 430

[Docket No. 97-013F]
RIN 0583-AC46


Control of Listeria monocytogenes in Ready-to-Eat Meat and 
Poultry Products

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Interim final rule.

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

DATES: This interim final rule is effective on October 6, 2003.
    Comments on the information presented under ``Paperwork Reduction 
Act'' must be received by August 5, 2003.
    Recognizing, however, that some approaches to L. monocytogenes 
control set out in this interim final rule are novel, FSIS will accept 
comments on the rule until December 8, 2004, for the purpose of 
reviewing and evaluating the effectiveness of these approaches.

ADDRESSES: One original and two copies of each comment should be sent 
to FSIS Docket 97-013F, U.S. Department of Agriculture, Food 
Safety and Inspection Service, Room 102 Cotton Annex, 300 12th Street, 
SW., Washington, DC 20250-3700. Comments will be available for public 
inspection in the Docket Clerk's Office between 8:30 and 4:30 p.m., 
Monday through Friday.

FOR FURTHER INFORMATION CONTACT: Daniel L. Engeljohn, Ph.D., Acting 
Assistant Deputy Administrator, Policy Analysis and Formulation, Office 
of Policy, Program Development, and Evaluation, Food Safety and 
Inspection Service, U.S. Department of Agriculture (202) 205-0495. 
Copies of references cited in this document are available in the FSIS 
Docket Clerk's Office, Room 102, Cotton Annex, 300 12th Street, SW., 
Washington DC 20250-3700. The Office is open 8:30 a.m. to 4:30 p.m., 
Monday through Friday.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Background
II. Listeria monocytogenes
III. Events leading up to the proposed rule
    Outbreaks and recalls 1999 reassessment notice
    FSIS action plan
    FDA/FSIS draft risk ranking
IV. Proposed rule provisions on L. monocytogenes
    Compliance guidance
    Opportunity for public comment
    Public meetings on Listeria
V. FSIS risk assessment of L. monocytogenes in RTE meat and poultry 
products
VI. Comments on the proposal and FSIS response
VII. The Interim Final Rule: Control of L. monocytogenes
    Alternative 1
    Alternative 2
    Alternative 3
    Estimates of annual production volume
    Labeling incentive
    New and existing regulatory requirements
VIII. Implementation
    Implementation strategy
    New directive for FSIS inspection program employees
IX. Consumer outreach effort
X. Executive Order 12866 and Effect on Small Entities
    Summary of final regulatory impact analysis
XI. Paperwork Reduction Act and Government Paperwork Elimination Act
XII. Executive Order 12988
XIII. Additional public notification
XIV. Final Regulations
Appendix A

I. Background

    The Food Safety and Inspection Service (FSIS) administers 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.) to ensure 
that meat, poultry, and egg products prepared for distribution in 
commerce are wholesome, not adulterated, and properly marked, labeled, 
and packaged. The FMIA and PPIA prohibit anyone from selling, 
transporting, offering for sale or transportation, or receiving for 
transportation in commerce, any adulterated or misbranded meat or 
poultry product (21 U.S.C. 610, 458).
    Under the Acts, a meat or poultry product is adulterated if, among 
other circumstances, it bears or contains any poisonous or deleterious 
substance that may render it injurious to health (21 U.S.C. 601(m)(1), 
453(g)(1)); if it is for any reason unsound, unhealthful, unwholesome, 
or unfit for human food (21 U.S.C. 601(m)(3), 453(g)(3); or if it has 
been prepared, packed, or held under insanitary conditions whereby it 
may have been rendered injurious to health (21 U.S.C. 601(m)(4), 
453(g)(4). Such a product is misbranded if, among other circumstances, 
it fails to bear directly or on its container the official inspection 
legend (e.g., for meat products, ``U.S. Inspected and Passed'' plus the 
official establishment number) prescribed in the regulations (21 U.S.C. 
601(n)(12), 453(h)(12)). The Acts require FSIS to carry out an 
inspection of meat, meat food products, and poultry products to ensure 
that the products are not adulterated (21 U.S.C. 606, 455), and if the 
products are found upon inspection to be not adulterated, they must 
bear directly or on their containers the official inspection legend (21 
U.S.C. 606, 607, 457).
    The Acts give FSIS broad authority to promulgate such rules and 
regulations as are necessary to carry out the Acts (21 U.S.C. 621, 
463). The Acts require FSIS to prescribe rules and regulations 
governing the sanitary conditions under which the establishments that 
produce these products are to be operated (21 U.S.C. 608, 456).
    On February 27, 2001, FSIS proposed (66 FR 12589) to establish 
several new requirements for the processing of ready-to-eat (RTE) and 
other meat and poultry products. The Agency proposed food safety 
performance standards for all RTE and all partially heat-treated meat 
and poultry products. The proposed performance standards set both 
levels of pathogen reduction and limits on pathogen growth that 
official meat and poultry establishments must achieve in order to 
produce products that are not adulterated. FSIS also proposed to allow 
the use of customized, plant-specific processing procedures and 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).
    Finally, FSIS proposed environmental testing requirements intended 
to verify measures to reduce the incidence of L. monocytogenes in RTE 
meat and poultry products. Specifically, FSIS proposed to

[[Page 34209]]

require establishments that produce RTE meat and poultry products to 
test food contact surfaces for Listeria species to verify that 
establishments were controlling the presence of L. monocytogenes within 
their processing environments. Under the proposal, establishments that 
developed and implemented HACCP controls for L. monocytogenes would be 
exempt from these testing requirements because the HACCP regulations 
require on-going monitoring and verification to demonstrate that the 
food safety system is working.
    In this interim final rule, FSIS is amending its regulations only 
in regard to the control of L. monocytogenes in RTE products. FSIS 
plans to address the other proposed provisions in future Federal 
Register publications. In view of recent outbreaks of foodborne 
listeriosis, as well as recent recalls of meat and poultry products 
adulterated by L. monocytogenes, the Agency has decided to adopt these 
regulations before completing action on the other provisions of the 
proposal.

II. Listeria monocytogenes

    L. monocytogenes is a pathogenic bacterium found in the environment 
(e.g., in soil, water, and vegetation and on the surfaces of equipment, 
floors, and walls) and is often carried by healthy animals (including 
humans). L. monocytogenes is spread very easily by direct food contact 
with a contaminated surface, and it can survive and grow in a 
refrigerated, packaged RTE product.
    L. monocytogenes grows under low-oxygen conditions and at low 
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 because of 
post-processing contamination. Consumption of food contaminated with L. 
monocytogenes can cause listeriosis. Listeriosis is a potentially fatal 
disease in newborns, the elderly, and persons with weakened immune 
systems, such as those with chronic disease or human immunodeficiency 
virus (HIV) infection or those taking chemotherapy for cancer. 
Listeriosis is also 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 illness or fetal death.
    Each year, according to the Centers for Disease Control and 
Prevention (CDC), L. monocytogenes causes 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 show 
that the case-fatality rate varies by age, with a higher case-fatality 
rate among newborns and the elderly.\1\
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    \1\ Mead, P. S., L. Slutsker, V. Dietz, L. F. McCraig, S. 
Bresee, C. Shapiro, P. M. Griffin, and R. V. Tauxe. 1999. Food-
related illness and death in the United States. Emerging Infectious 
Diseases 5:607-625.
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    L. monocytogenes is one of several foodborne pathogens that have 
been a special focus of public health strategies, such as Healthy 
People 2010. Organized by the Department of Health and Human Services 
(HHS), Healthy People 2010 is a comprehensive, nationwide health 
promotion and disease prevention agenda for increasing the quality and 
years of healthy life. The food safety objectives of Healthy People 
2010 include infection reduction targets for pathogens of concern. The 
2010 target for L. monocytogenes is to reduce by 50 percent the rate of 
illnesses below the 2001 level of 0.5 cases per 100,000 population.
    A number of factors can cause or contribute to L. monocytogenes 
contamination of RTE meat and poultry products in a meat or poultry 
processing establishment. First, if the pathogen is already present in 
product ingredients, a processing error, such as incorrect formulation 
or inadequate processing time or temperature, can result in the 
production of products containing live organisms. Second, a product 
that has undergone a successful lethality treatment can be contaminated 
by biofilms on food-contact surfaces of equipment used for processing, 
handling, or packaging the product. The product can also be exposed to 
environmental contamination or cross-contamination in the post-
lethality processing environment. One cause of cross-contamination can 
be plant construction in the post-lethality area of the establishment, 
unless precautions are taken to protect the products during the period 
of construction. Serious outbreaks of listeriosis have occurred because 
of the failure to take such precautions during facilities construction 
or remodeling.
    Additional causes of contamination or cross contamination can be 
poor facilities design or plant equipment layout. Cross-contamination 
can occur if the flow paths of raw product and finished products cross 
or if vehicle or personnel traffic from outside the plant or from a 
raw-product area of the plant enters an area where exposed finished 
products are handled. Contamination or cross-contamination also can 
occur if processing equipment has not been designed for easy cleaning, 
or if equipment or facilities have hard-to-reach niches that can harbor 
L. monocytogenes or other pathogens.

III. Events Leading Up to the Proposed Rule

Outbreaks and Recalls

    During the 1980's, L. monocytogenes began to emerge as a problem in 
processed meat and poultry products. FSIS and FDA worked with 
processing plants to improve their procedures and emphasized a ``zero 
tolerance''--no detectable levels of viable pathogens--for the organism 
in RTE products. Between 1989 and 1993, the rate of illness from L. 
monocytogenes declined 44 percent.
    In the fall of 1998, State health departments and the CDC 
investigated an outbreak of foodborne illness in which hotdogs and, 
possibly deli (luncheon) meats, were implicated. CDC and FSIS 
investigators isolated the outbreak strain, a strain of L. 
monocytogenes, from an opened and previously unopened package of 
hotdogs manufactured by a single plant. CDC eventually reported 101 
illnesses, 15 adult deaths, and 6 stillbirths or miscarriages 
associated with the outbreak.
    Another outbreak of listeriosis occurred between May and December 
2000 and was spread over 10 States. CDC linked a strain of L. 
monocytogenes to 29 illnesses--8 perinatal and 21 non-perinatal--
resulting in 4 deaths and 3 in miscarriages or stillbirths. Subtyping 
by pulsed-field gel electrophoresis (PFGE) showed the L. monocytogenes 
strains to be indistinguishable from one another.
    The outbreak was linked to eating turkey deli meat. Thirteen stores 
and delicatessens where patients reported purchasing turkey meat 
obtained their turkey meat from at least 27 federally inspected 
establishments. Two establishments were linked to 10 of 11 patients. 
FSIS traced the implicated turkey meat to a Texas poultry processor.

1999 Reassessment Notice

    In 1999, with the emergence of an especially virulent strain of L. 
monocytogenes, the Agency concluded that many establishments should 
reassess their HACCP plans. FSIS published in the Federal Register a 
Notice (64 FR 28351; May 26, 1999) advising manufacturers of RTE meat 
and poultry products of the need to reassess their HACCP plans to 
ensure that the plans were, in fact, adequately

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addressing L. monocytogenes. If the reassessment revealed that L. 
monocytogenes was a hazard reasonably likely to occur in an 
establishment's production process, the establishment would have to 
address the hazard in its HACCP plan.
    The same month, FDA and FSIS announced plans to conduct a 
quantitative microbial risk assessment to determine the extent of 
consumer exposure to foodborne L. monocytogenes in RTE foods (64 FR 
24661; May 7, 1999).

FSIS Action Plan

    A May 5, 2000, Presidential directive on L. monocytogenes in RTE 
foods revised the Healthy People 2010 target date for reducing 
illnesses caused by the pathogen up to 2005 and set other objectives. 
HHS and USDA responded to this directive with an eight-point action 
plan providing for consumer, health-care provider, and industry 
education; redirection of enforcement strategies, including increased 
microbial sampling; enhanced disease surveillance; coordinated research 
activities; and proposing new regulations. For its part, FSIS announced 
its intention to publish a proposed rule that would, among other 
things, require establishments to conduct environmental testing for 
Listeria species in order to verify the effectiveness of their 
sanitation standard operating procedures (Sanitation SOPs).

FDA/FSIS Draft Risk Ranking

    FDA and FSIS made public a preliminary draft of a risk ranking in 
January 2001 (66 FR 5515; January 19, 2001). The risk ranking (see 
http://www.foodsafety.gov/dms/lmrisk.html) estimated the relative risks 
of serious illness and death from listeriosis that may be associated 
with consumption of different types of RTE foods. The risk ranking did 
not cover listerial gastroenteritis, a less serious infection with mild 
flu-like symptoms. The risk ranking (1) estimated the potential level 
of exposure of three age-based U.S. population groups to L. 
monocytogenes contaminated foods in 20 food categories and (2) related 
this exposure to public health consequences. The food categories 
studied included foods with a history of L. monocytogenes 
contamination. The models used in the risk ranking provided a means of 
predicting the likelihood that severe illness or death will result from 
consuming foods contaminated with this pathogen. Estimates were made of 
the relative risks posed by the food categories, but the risk ranking 
did not predict the precise public health consequences attributable to 
any particular contaminated food.
    The foods considered in this risk ranking were RTE foods that are 
generally eaten without being cooked (e.g., cheese) or are typically 
reheated (e.g., frankfurters) before consumption. The main categories 
considered were seafood, produce, dairy, meat, and combination foods. 
The population groups evaluated were: (1) perinatal, including fetuses 
and neonates from 16 weeks after fertilization to 30 days postpartum. 
These are pregnancy-associated cases where exposure occurs most often 
in utero as a result of foodborne L. monocytogenes infections of the 
mothers during pregnancy and may result in spontaneous abortions, 
stillbirths, and neonatal infections; (2) elderly, that is, individuals 
who are 60 or more years of age; and (3) the intermediate-age group, 
including the remaining population, both healthy individuals (with very 
low risk of severe illness or death from L. monocytogenes) and certain 
susceptible population groups.
    The population groups included individuals with increased 
susceptibility to listeriosis, such as acquired immune deficiency 
syndrome (AIDS) patients or individuals taking drugs that suppress the 
immune systems (e.g., cancer or transplant drugs). Individuals within 
these susceptible population groups account for most of the cases of 
listeriosis within the intermediate-age group. The risk ranking focused 
on the overall burden of listeriosis on public health and includes the 
occurrence of both sporadic illnesses (i.e., illnesses not associated 
with a documented outbreak) and outbreak illnesses.
    The results of the risk ranking indicated that certain RTE meat and 
poultry products presented a relatively moderate to high risk for 
listeriosis. These included p[acirc]t[eacute]s and meat spreads, deli 
meats, hotdogs, and deli salads containing meat or poultry products. 
Further, there was a significant opportunity for recontamination of RTE 
meat and poultry products in the processing establishment.

IV. Proposed Rule Provisions on L. monocytogenes

    The Agency concluded that many establishments were not effectively 
implementing HACCP plans and Sanitation SOPs to prevent L. 
monocytogenes from contaminating the RTE product in the post-lethality 
processing environment. The Agency therefore resolved to proceed to 
rulemaking to correct the problem. In February 2001, FSIS issued a 
proposed rule that would require that establishments that produce post-
lethality exposed RTE meat or poultry products conduct testing of food 
contact surfaces for Listeria species in areas of the establishments 
into which the products are routed after undergoing lethality treatment 
and before final product packaging. All establishments would be 
required to do this unless they had incorporated one or more controls 
validated to prevent, reduce to an acceptable level, or eliminate the 
L. monocytogenes from their products into their HACCP systems.
    The proposed testing was intended to verify that the 
establishment's Sanitation SOP was preventing direct product 
contamination by L. monocytogenes after the products had undergone a 
lethality treatment. FSIS recognized that there is a significant risk 
for RTE meat and poultry products to become re-contaminated by L. 
monocytogenes if they came into contact with the pathogen, and that 
testing was necessary to verify that the procedures conducted under the 
Sanitation SOP had killed or eliminated the pathogen.
    Under the proposal, if an establishment found that a food contact 
surface had tested positive for Listeria species, the establishment 
would have to take the corrective action necessary to properly clean 
the surfaces and to prevent product that may have become contaminated 
through contact with the surface from entering commerce.
    Under the proposal, an establishment that had identified L. 
monocytogenes as a hazard reasonably likely to occur in its HACCP plan, 
and that had established CCPs for L. monocytogenes, was exempt from the 
proposed mandatory testing frequency requirement because HACCP 
regulations already require monitoring and verification, including 
testing frequency, as validated in the HACCP plan. An establishment 
that did not explicitly identify L. monocytogenes as a hazard 
reasonably likely to occur, but whose HACCP controls for biological 
hazards effectively prevented, eliminated, or reduced product 
contamination by the pathogen, would have had to make only minor 
amendments in its HACCP plan and supporting documentation to reflect 
that L. monocytogenes had been identified as a hazard addressed by the 
HACCP plan. In any case, if HACCP controls were implemented, the 
establishment would have to develop and validate the monitoring and 
verification procedures used to document the on-going effectiveness of 
the system. FSIS did not specify minimum monitoring and verification 
requirements for these processors.

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    The Agency has made it clear that, in its view, contamination with 
L. monocytogenes is a hazard reasonably likely to occur in all RTE meat 
and poultry products that are exposed to the processing environment 
post-lethality. Significant concerns about such contamination underlay 
the Agency's May 26, 1999, Federal Register Notice advising 
manufacturers of RTE meat and poultry products of the need to reassess 
their HACCP plans to determine whether the plans were appropriately 
addressing L. monocytogenes. In the proposal, however, the Agency 
acknowledged that, even though L. monocytogenes was a significant 
concern in RTE products, it may not be necessary to address this 
pathogen in the HACCP plan itself. FSIS acknowledged that this pathogen 
may be present but not necessarily likely to occur because the 
establishment had measures in place, such as Sanitation SOPs, that 
effectively prevented contamination by the pathogen in the food 
processing environment. An establishment might have incorporated the 
controls in its Sanitation SOP and thereby prevented the pathogen from 
posing a contamination hazard in the processing environment.
    Consequently, to verify that such plants were effectively 
preventing environmental contamination, FSIS proposed to require that 
establishments without HACCP controls for L. monocytogenes test food 
contact surfaces for Listeria species at a frequency that was based on 
the relative size of the establishments. FSIS proposed that large 
establishments subject to the requirement conduct at least four such 
tests per line per month; small establishments at least two per line 
per month; and very small establishments at least once per line per 
month. A large establishment was one employing more than 500 employees; 
a small establishment from 10 to 499 employees; and a very small 
establishment one employing fewer than 10 employees and grossing less 
than $2.5 million in sales. These are the same size criteria the Agency 
had used in its 1996 final rule on HACCP systems (61 FR 38806).
    The Agency solicited information on the proposed rule, including 
the efficacy of the testing frequencies, their potential cost to 
industry, the relationship between Listeria species on food contact 
surfaces and L. monocytogenes in product, and the various factors that 
might be important in devising effective testing protocols.
    FSIS also proposed that establishments take certain actions after 
obtaining a positive food contact surface test result for Listeria 
species. An establishment with such a result would have to take the 
corrective action defined in its Sanitation SOP. The establishment 
would have to 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 acknowledged that 
some establishments would have to modify their Sanitation SOP 
corrective actions to include such elements.
    FSIS requested comment on whether Listeria-positive test results on 
different food contact surfaces (such as surfaces that had been treated 
with a bactericide versus those that had not) should be treated 
differently; whether the Agency should establish more specific 
requirements on product sampling following a Listeria-positive test on 
a food contact surface; and whether an establishment should have to 
determine whether a Listeria-positive sample is L. monocytogenes before 
having to initiate product testing.
    FSIS stated in the preamble of the proposal that if a sampled lot 
is found to be positive for L. monocytogenes, and the product from the 
lot is already in commerce, the Agency would request that the product 
be recalled. Further, the Agency stated, if product is found to be 
positive for L. monocytogenes, the establishment that produced it would 
likely have to establish controls for the pathogen within its HACCP 
plan.
    FSIS noted that the two provisions addressing Listeria 
contamination contained in the proposed rule, HACCP and Sanitation 
SOPs, required specific daily action to ensure that product is not 
adulterated. FSIS stated that, as of the time of the proposal, it did 
not consider programs outside of Sanitation SOPs and HACCP to be 
sufficient to prevent the hazards associated with post-lethality 
contamination with Listeria in the manufacture of RTE products. For one 
thing, the Agency noted, documentation of corrective and preventive 
actions taken in such programs, known as GMPs (good manufacturing 
practices) or prerequisite programs, generally was not being provided 
to the Agency.
    Compliance guidance: In the proposal, FSIS made a commitment to 
provide compliance guidance to establishments on testing frequencies 
and methodologies and appropriate corrective actions to take following 
positive tests on samples from food contact surfaces. FSIS also said it 
would publish guidance on available interventions (techniques for 
killing L. monocytogenes) establishments can implement as CCP's. FSIS 
made the draft compliance guidance available on its Web site after 
publication of the proposal.

Opportunity for Public Comment

    FSIS provided a 90-day comment period. On April 13, 2001, FSIS 
published a Federal Register notice (66 FR 19102) extending the comment 
period an additional 30 days, through June 28, 2001, to provide 
opportunity for the public to comment on issues raised at a technical 
conference and public meetings that the Agency held May 8-10, 2001, on 
the proposed regulations. After the extended comment period expired, 
the Agency announced, in a July 3, 2001, Federal Register notice (66 FR 
35112), that at the request of a consortium of trade associations, the 
Agency was reopening the comment period for an additional 30 days, 
until September 10, 2001. The consortium had said that it needed the 
additional time to review the large amount of scientific and economic 
data presented at the May 8-10 meetings, FSIS's draft compliance 
guidelines, and the draft FDA/FSIS risk ranking on the relationship 
between foodborne L. monocytogenes in RTE foods and human health.

Public Meetings on Listeria

    During the development both of the proposal and this interim final 
rule, FSIS held a series of meetings with constituents and with 
technical and scientific experts on the problem of L. monocytogenes and 
how to control it. Some meetings were prompted by large-scale product 
recalls due to contamination with the pathogen or actual outbreaks of 
listeriosis.
    In February 1999, following the late-1998 listeriosis outbreak and 
a recall of hotdogs and deli meats that had been contaminated with L. 
monocytogenes, FSIS held a public meeting on the food safety issues 
related to L. monocytogenes in meat and poultry products. At the 
meeting, industry and government procedures were discussed, including 
sampling programs for RTE products and the best ways to educate ``at 
risk'' populations about Listeria.
    On May 15, 2000, FSIS held a public meeting to discuss current 
Agency initiatives to prevent human illness from L. monocytogenes in 
RTE meat and poultry products; the use of Listeria species as an 
indicator organism for L. monocytogenes; and the efficacy of 
environmental testing for Listeria species.
    On May 8, 2001, FSIS held a public meeting to discuss scientific 
research and new technologies for detecting and controlling L. 
monocytogenes in RTE

[[Page 34212]]

meat and poultry products. At this meeting, FSIS requested data 
relevant to the proposed regulation regarding frequencies of testing 
for environmental Listeria species and the correlation of potential 
product contamination with production volume.
    On November 18, 2002, FSIS held a public meeting to provide a forum 
for experts from government, academia, industry, and elsewhere to 
discuss current research and information related to improving the 
safety of RTE products. The topics discussed included the role of 
environmental and product testing, decontamination strategies, and 
consumer behaviors related to RTE foods. At the meeting, FSIS released 
a new draft directive (Directive 10,240.3, discussed below) on FSIS 
microbiological testing of RTE products for a number of organisms, 
including L. monocytogenes.
    An additional public meeting was held February 26, 2003, to discuss 
an FSIS draft risk assessment which had been conducted to determine the 
likelihood that L. monocytogenes may contaminate RTE meat and poultry 
products during production and packaging processes. The Agency's draft 
risk assessment was released February 14, 2003, and was posted on the 
FSIS Web site (at http://www.fsis.usda.gov/OPHS/lmrisk/DraftLm22603.pdf). Copies also were made available in the FSIS Docket 
Room. Public and peer reviewer comments on the risk assessment and the 
Agency's response to the comments also can be viewed in the Docket Room 
and on the Web site.

V. FSIS Risk Assessment of L. monocytogenes in RTE Meat and Poultry 
Products

    The FSIS risk assessment and the FDA/FSIS risk ranking on L. 
monocytogenes in RTE foods sold at retail provided a framework for 
evaluation of, and data on, risk mitigation strategies, including in-
plant measures, to inform the Agency in this rulemaking as it 
considered the need to address potential contamination of RTE products 
by the pathogen.
    FSIS initiated its Listeria risk assessment in February 2002 in 
response to public comments on the proposed rule that suggested the 
need for a stronger scientific basis for provisions requiring the 
testing of food contact surfaces for Listeria species. The risk 
assessment was developed: (1) To provide insight into the relationship 
between Listeria species on food contact surfaces and L. monocytogenes 
in RTE meat and poultry products exposed to the environment after the 
lethality treatment (post-lethality exposure); and (2) to evaluate the 
effectiveness of food contact surface testing and sanitation regimes, 
pre- and post-packaging interventions, growth inhibitors, and 
combinations of these interventions to mitigate contamination of RTE 
meat and poultry products that are post-lethality exposed, and to 
reduce the subsequent risk of illness or death from L. monocytogenes.
    FSIS risk managers asked that the FSIS risk assessors evaluate the 
effect of various food contact surface testing and sanitation regimes 
in reducing L. monocytogenes contamination of products and the effect 
of other pre- or post-packaging antimicrobial interventions and of 
growth inhibitors in reducing such contamination. The risk managers 
also sought guidance from the risk assessors on testing and sanitation 
of food contact surfaces for Listeria species.
    Given the available data and the fact that deli meats comprised 
about 80 percent of the listeriosis cases associated with ready-to-eat 
product, the FSIS risk assessment addressed only deli products. In 
order to evaluate the specific FSIS risk management questions, the risk 
assessment assumed that all L. monocytogenes on RTE product comes from 
the food contact surfaces and not from inadequate lethality treatment.
    Using available data, the FSIS risk assessors developed a dynamic 
in-plant Monte Carlo simulation model (referred to as the in-plant 
model) quantitatively characterizing the relationship between Listeria 
species in the in-plant environment and L. monocytogenes in a 
production lot of RTE product at retail.
    The outputs of the in-plant model (e.g., concentration of L. 
monocytogenes on deli meats at retail) were used as inputs into the two 
major components of the FDA/FSIS risk ranking model discussed earlier: 
the exposure assessment and the associated dose-response relationship 
for deli meats.
    In the FDA/FSIS risk ranking, the retail-to-table exposure 
assessment for deli meats and the associated dose-response relationship 
were developed to identify which RTE foods pose the greatest risk for 
causing listeriosis. Two components of the FDA/FSIS risk ranking model, 
the exposure assessment for deli meats and the dose-response 
relationship, were later updated with data and information provided 
during the public comment period on the draft FDA/FSIS risk ranking. 
The updated exposure assessment is used to track the level of L. 
monocytogenes in deli meat from retail to table and, using the updated 
dose-response relationship for L. monocytogenes, provides estimates of 
the subsequent risk of illness or death from consuming deli meats.
    The outputs of the FSIS risk assessment model were calibrated to 
the L. monocytogenes concentration in deli meats at retail in the 
updated FDA/FSIS exposure assessment. That is, the FSIS output data 
were statistically compared with standard data on L. monocytogenes from 
a reputable third-party to determine whether the output data deviated 
from the standard data. Calibration of risk assessment models is 
intended to ensure the accuracy of risk estimates.
    By modeling changes in in-plant practices, such as the frequency of 
testing and sanitation of food contact surfaces, the FSIS risk 
assessment model provides insight into the effects of these practices 
on the annual risk of illness or death from L. monocytogenes in RTE 
meat and poultry products. The risk assessment model was designed to 
provide numerous outputs that depended on the selection of in-plant 
practices, such as ``test and hold,'' responding after an initial 
positive food contact surface sample, or alternatively, after 
consecutive positive samples, and that were based on various plant 
characteristics (e.g., plant size or production volume).
    The most significant findings of the risk assessment model are: (1) 
The proposed minimal frequency of testing and sanitation of food 
contact surfaces (66 FR 12589, February 27, 2001) results in a small 
reduction in the levels of L. monocytogenes on deli meats at retail; 
and (2) combinations of interventions (e.g., sanitation/testing of food 
contact surfaces, pre- and post-packaging lethality interventions, and 
growth inhibitors) appear to be much more effective than any single 
intervention in mitigating the potential contamination of finished RTE 
products with L. monocytogenes and reducing the subsequent risk of 
illness or death.
    Specific model outputs relating to L. monocytogenes concentrations 
in deli products at retail and the resulting public health impacts of 
various interventions were developed and were presented at a public 
meeting on February 26, 2003. FSIS accepted comments on its draft risk 
assessment at the public meeting and afterward, until March 14, 2003 
(68 FR 6109; February 6, 2003). The comments received have been 
included in the record of this rulemaking proceeding. An analysis of 
comments and responses is available in the FSIS Docket Clerk's Office 
and on the FSIS Web site at: http://www.fsis.usda.gov.

[[Page 34213]]

VI. Comments on the Proposal and FSIS Response

    On the proposed requirements for controlling Listeria in RTE 
products in the February 27, 2001, Federal Register document, FSIS 
received 28 comments. Comment summaries, grouped by topic, and Agency 
responses follow.

Support for the Proposal

    Comment: Three comments supported the proposed rule and favored 
even more stringent requirements. They said that manufacturers of RTE 
products should be required to implement programs for detecting and 
eliminating L. monocytogenes harborages and should perform tests for L. 
monocytogenes and Listeria species. All establishments that produce 
such products should have control programs that include environmental 
testing. The Agency should require establishments that have CCPs for L. 
monocytogenes to conduct testing. Also, the proposed required sampling 
frequencies should be increased and the intervals between tests 
specified. FSIS should mandate specific testing frequencies for product 
testing to be conducted following an environmental test that is 
positive for Listeria. Two of the commenters suggested that Listeria 
species is an appropriate indicator for L. monocytogenes.
    The commenters said that FSIS should require even more intensive 
environmental and product testing than that proposed. Final product 
testing as well as environmental testing should be required; 
eventually, continuous product testing should be performed. One 
commenter opposed the notion of adopting food irradiation as a solution 
for potential contamination of RTE products.
    One commenter said that the Agency should require establishments to 
test a statistically significant amount of RTE product for L. 
monocytogenes. The establishments also should conduct environmental 
testing for the organism. If the products are produced by an 
establishment that does not conduct RTE product testing as part of its 
HACCP plan, the products should carry warning labels.
    Commenters said that FSIS should maintain its ``zero tolerance'' 
for L. monocytogenes in RTE products rather than setting a minimum 
colony-forming-unit (CFU) level for the organism in the products, as 
some have suggested.
    A commenter said that official establishments should identify 
sources of L. monocytogenes in their Sanitation SOP.
    Response: FSIS agrees with comments that supported establishment 
use of effective process controls combined with environmental testing 
to verify the effectiveness of sanitation programs. The Agency also 
agrees with the comment that establishments should address sources of 
L. monocytogenes either in their HACCP plans or in their Sanitation 
SOPs or other appropriate procedures. This interim final rule provides 
a framework within which establishments must meet this objective and 
provides flexibility for doing so.
    FSIS does not agree that it is necessary to mandate Listeria 
testing for establishments that have a CCP for L. monocytogenes. Such 
establishments are already required to validate and verify the CCP's, 
and microbiological testing is an important means of validation and 
verification.
    FSIS also believes that, if it mandated a high frequency of 
environmental or product testing, the Agency would be foreclosing 
unnecessarily the use of effective control programs or strategies 
adopted by establishments that might require testing at frequencies 
different from those mandated. In this interim final rule, FSIS is not 
adopting the proposed frequency requirements. Instead, the Agency is 
requiring establishments to adopt one of several alternatives that are 
appropriate for their products and process controls that are effective 
in addressing L. monocytogenes.
    On the question of a ``zero tolerance'' for L. monocytogenes and 
particularly with respect to RTE products that support growth of the 
pathogen, FSIS currently regards any amount of the organism as a 
product adulterant. As stated above, because the product is RTE, it is 
likely to be consumed without any effort to kill the pathogen, and the 
presence of the pathogen may render the product injurious to health (21 
U.S.C. 601(m)(1), 453(g)(1)) and would cause the product to be 
unhealthful.

General Comments on the Proposal and Its Scientific Basis

    Comment: A number of commenters said that the proposed testing 
requirements are arbitrary, unsupported by the FDA/FSIS risk ranking, 
and generally unscientific (i.e., they were not based on the relative 
risk posed by establishments, products, or processes).
    Response: FSIS agrees, in principle, that mandating a testing 
frequency is not well founded. In this interim final rule, FSIS is not 
adopting the proposed provisions for testing food contact surfaces at 
specified frequencies. Under the interim final rule, establishments 
will have to implement effective controls for L. monocytogenes. The 
interim final rule is based on the Agency's conclusion that 
establishments that process post-lethality exposed RTE products must 
address L. monocytogenes in their food safety systems. Those 
establishments that rely only on sanitation procedures to control the 
pathogen should carry out more intensive verification procedures, such 
as food contact surface testing, to ensure that the procedures are 
effective, and that products are not contaminated, than establishments 
that controls the pathogen through their HACCP plans.

Severity of Effects

    Comment: In framing the rule, FSIS should consider the relative 
risk of illness posed by RTE products and the severity of effects.
    Response: FSIS has taken into account the relative risk of illness 
and death posed by the processes and products addressed by this interim 
final rule as reported in the FDA/FSIS risk ranking of RTE foods sold 
at retail and the FSIS risk assessment.

Success of Industry Efforts

    Comment: The industry has been successful in lowering the incidence 
of foodborne listeriosis. The industry's efforts will help the country 
achieve the Department of Health and Human Service's ``Healthy People 
2010'' goals for lowering the incidence of listeriosis in the 
population within the timeframe established in the May 5, 2000, 
Presidential directive. Thus, the Agency's proposal to require 
environmental testing is unjustified, especially in view of the fact 
that HACCP was intended to obviate the need for this type of 
prescriptive requirement.
    Response: Although it is early to determine whether the ``Healthy 
People 2010'' goals for reducing listeriosis (to 0.25 cases per 100,000 
population) will be achieved, recent data from CDC indicate that from 
1996 to 2002 there was a 38-percent decline in the number of cases per 
100,000 population (to .27 overall). Nonetheless, meat and poultry 
products have been implicated in a substantial proportion (nearly half) 
of listeriosis cases. FSIS believes that the meat and poultry industry, 
together with other segments of the food industry, is capable of 
contributing significantly to the achievement of the Nation's goals for 
Listeria control, particularly by focusing on higher-risk meat and 
poultry products and on mandatory control procedures--the approach 
taken in this interim final rule. This interim final rule does not, 
however, mandate specific testing frequencies.

[[Page 34214]]

Effectiveness of Industry Controls

    Comment: Some commenters stated that the current HACCP and 
Sanitation SOP requirements are adequate for ensuring control of 
Listeria. Therefore, the need for regulatory change in this area is 
questionable.
    Response: It is true that validated HACCP plans and effective 
Sanitation SOPs should be sufficient to address the Listeria hazard. 
The continuing occurrence of product contamination and of significant 
outbreaks of illness in which meat and poultry products are implicated, 
however, suggest that establishments have not appropriately addressed 
the hazard in their HACCP plans, and that the effectiveness of 
establishment Sanitation SOPs used to control L. monocytogenes 
contamination is not being ensured. The Agency has therefore concluded 
that it is necessary to require establishments to take specific steps 
to control the Listeria hazard.

Ubiquity of L. monocytogenes and Difficulty of Controlling It

    Comment: Several commenters stated that it is important to 
recognize how ubiquitous L. monocytogenes is in the environment and 
that elimination of L. monocytogenes from all food is probably 
impossible. Thus, the commenters believe, it is not appropriate to 
require product testing on the basis of a single positive test for 
Listeria spp. on a food contact surface. Some commenters said that 
environmental testing results should not lead to enforcement actions.
    Response: While FSIS does not think that the ubiquity of an 
organism in the environment argues against regulations requiring 
control of the organism, the Agency agrees that a more flexible 
approach to L. monocytogenes control than that taken in the proposal is 
warranted and desirable. FSIS is not adopting the proposed requirement 
to test product after the first positive test on a food contact 
surface. Although a positive test for Listeria species on a food 
contact surface does not necessarily mean that product is adulterated, 
or that enforcement action should be taken, such a finding does suggest 
the need for corrective action. FSIS inspection program personnel are 
instructed to verify that the establishment takes the corrective 
actions it has developed, whether as part of a HACCP plan or of a 
Sanitation SOP or other prerequisite program.
    On the other hand, FSIS regards a positive test for L. 
monocytogenes on a food contact surface as evidencing an insanitary 
condition that may render product injurious to health. RTE product that 
comes into contact with the sampled surface at the time it was 
contaminated with the pathogen and is not subject to any further 
lethality treatment is adulterated, and FSIS inspection program 
personnel will take the appropriate action in response to such a 
finding as set out in Agency directives.

Incentives and Disincentives

    Comment: The proposed testing requirements are a disincentive to 
control L. monocytogenes and may actually increase risk of foodborne 
listeriosis. Establishments might test for the organism at a lower rate 
than they currently do lest positive tests lead to unwarranted 
enforcement actions by FSIS. Many small and very small establishments 
have already implemented L. monocytogenes control measures (GMPs, 
Sanitation SOPs, and testing) in excess of the proposed requirements.
    Response: FSIS agrees that mandating testing at a fixed frequency 
might discourage some establishments that are making strong efforts at 
Listeria control that include regular testing. This recognition 
factored into the Agency's decision not to adopt the proposed testing 
frequencies in this interim final rule.
    Comment: FSIS should provide incentives for finding harborages, 
taking corrective actions, and preventing the recurrence of 
contamination.
    Response: FSIS agrees with the comment. When the interim final rule 
becomes effective, FSIS verification testing will be more intensive in 
establishments where controls are less rigorous. (See discussion of new 
Directive 10,240.4 below.) Whether FSIS takes an enforcement action 
will depend on whether establishments are correcting insanitary 
conditions that may result in product adulteration.
    FSIS believes that this interim final rule gives establishments the 
flexibility to adopt innovative and effective Listeria control methods. 
Moreover, the interim final rule includes a provision enabling 
establishments to declare on their product labels their use of Listeria 
control measures, provided that the establishments can validate the 
declarations.

HACCP, Sanitation SOPs, Prerequisite Programs, Directives or 
Performance Standards

Listeria Controls in HACCP Plans

    Comment: Some commenters favored using equipment design, GMPs, and 
facilities management techniques to control L. monocytogenes. They 
stated that FSIS should recognize that enhanced and focused sanitation 
and employee behavior programs can be effective preventive and 
corrective actions. These commenters argued that contamination 
occurring in a post-lethality processing area is a sanitation, and not 
a HACCP, issue.
    Others argued, to the contrary, that L. monocytogenes should be 
controlled by CCPs in an establishment's HACCP plan.
    Response: FSIS is persuaded that L. monocytogenes contamination is 
being prevented in many establishments by Sanitation SOPs and other 
prerequisite programs. Where these programs are effective, an 
establishment may conclude in its hazard analysis that L. monocytogenes 
is not a hazard reasonably likely to occur. Of course, in the Agency's 
view, it is also appropriate to address this hazard in a HACCP plan. 
Thus, the Agency is allowing establishments the latitude to include L. 
monocytogenes control measures in HACCP plans or to address potential 
contamination by this pathogen in Sanitation SOPs or other prerequisite 
programs. It is important to note that if an establishment is applying 
a post-lethality treatment to an RTE product, the establishment must 
have concluded that L. monocytogenes is a hazard reasonably likely to 
occur in the product. For this reason, the establishment must include 
that treatment as a CCP in its HACCP plan.
    Comment: Since no technology exists to completely eliminate L. 
monocytogenes from products, a CCP for controlling L. monocytogenes is 
infeasible. Establishments should focus their resources on sanitation 
and plant improvement projects rather than on HACCP CCPs. Allowing 
plants to develop CCPs instead of testing, they said, would result in 
decreased consumer protection.
    Response: FSIS disagrees. A CCP in a HACCP plan is a point, step, 
or procedure in a food process where the occurrence of an identified 
hazard can be prevented, eliminated, or reduced to an acceptable level. 
Various methods are available to prevent, eliminate, or reduce L. 
monocytogenes in the RTE products that are subject to this interim 
final rule and their effectiveness can be validated. For example, a 
post-lethality heat treatment of a packaged product can eliminate the 
pathogen. Thus, establishments that use post-lethality treatments for 
this purpose should include the treatments in their HACCP plans. But 
establishments may use other methods, including the addition of 
antimicrobial agents, that have the effect of limiting or suppressing 
growth of L.

[[Page 34215]]

monocytogenes in the products. These methods need not be in the 
establishments' HACCP plans, so long as the plant is regularly ensuring 
that these methods are working effectively and is making its records 
that relate to these methods available to FSIS inspection personnel.

Use of Process Controls and Technologies to Control Listeria

    Comment: FSIS should encourage establishments to adopt effective 
process controls, such as food irradiation and high-pressure 
processing, rather than imposing testing requirements. Relying solely 
on Sanitation SOPs or GMPs would fail to control L. monocytogenes. 
Further, products that are subject to an in-package lethality treatment 
before being shipped should be exempt from both environmental and 
product testing requirements.
    Response: FSIS has designed the interim final rule to be 
sufficiently flexible that establishments will be able to implement a 
variety of technologies to address L. monocytogenes. Of course, before 
establishments can take advantage of food irradiation for the types of 
products covered by this interim final rule, FDA approval will be 
necessary.
    FSIS agrees that effective process controls will yield more 
beneficial results than testing requirements of the kind proposed and 
that establishments may use various methods to prevent or control L. 
monocytogenes contamination. Therefore, FSIS is not adopting the 
proposed testing frequency requirements. The Agency is permitting 
establishments that produce RTE products to implement the type of HACCP 
or sanitation program that is most appropriate for their production 
situation and is not imposing uniform testing requirements of the kind 
proposed. FSIS recognizes that different validation or verification 
testing regimes are appropriate for different types of products or 
process control programs, and that a combination of interventions, 
including post-lethality treatments, sanitation and testing, 
processing, and the use of growth inhibitors, appears to be most 
effective in controlling L. monocytogenes.

Resource Allocation to Testing or Process Controls

    Comment: FSIS has not shown how the proposed, prescriptive, 
environmental testing will reduce the incidence of L. monocytogenes in 
RTE products. If plants devote resources to environmental testing 
rather than to effective sanitation activities, consumer protection 
would decrease. Also, FSIS should let establishments use prerequisite 
programs instead of CCPs in the HACCP plan to control L. monocytogenes.
    Response: FSIS acknowledges that testing by itself is insufficient 
to control L. monocytogenes but needs to be a part of a sanitation 
control program. FSIS regards testing as an essential means of 
verifying the effectiveness of sanitation procedures to control L. 
monocytogenes, whether the procedures are incorporated in a HACCP plan, 
a Sanitation SOP, or another prerequisite program. Devoting resources 
to a testing program developed for this purpose actually supports the 
control measures.
    The proposed Listeria testing requirements, which would have 
mandated specific testing frequencies, were intended for Sanitation SOP 
verification. Although this interim final rule does not adopt the 
proposed testing frequency requirements, establishments that do not 
apply post-lethality treatments to their post-lethality exposed RTE 
products will have to include at least some food-contact surface 
testing in their sanitation programs. Such testing is intended to 
ensure that their measures for controlling, or preventing contamination 
by, L. monocytogenes, whether in HACCP plans or in Sanitation SOPs or 
other prerequisite programs, are effective.
    Comment: FSIS should set a performance standard for L. 
monocytogenes as it has for other pathogens of concern. The Agency 
should also give establishments the flexibility to meet the standard. 
Thus, the Agency should consider the problem of pathogen growth after 
processing and give plants maximum flexibility in testing for L. 
monocytogenes.
    Response: FSIS considered the option of adopting a process 
performance standard for controlling L. monocytogenes but determined 
that there was insufficient scientific information on which to base 
such a standard. Nonetheless, the Agency has given the establishments 
flexibility in deciding how to address this pathogen.

FSIS Directive on Microbial Sampling Procedures for RTE Products

    Comment: Some commenters said that the Agency should continue to 
have its personnel use FSIS Directive 10,240.2, which sets out the 
procedures to be followed when Agency personnel conduct microbiological 
sampling in establishments that produce RTE products, rather than 
issuing new regulations. They said that FSIS could revise the Directive 
and conduct some food contact surface testing, either in all 
establishments that produce RTE products or just in establishments that 
do not conduct their own sampling.
    Response: FSIS disagrees with the assertion that a regulation is 
not necessary to ensure effective control of L. monocytogenes in RTE 
products. As noted, with respect to the risk ranking, there is a 
significant opportunity for recontamination of RTE products in 
establishments. Many establishments are not implementing HACCP, 
Sanitation SOPs, or prerequisite programs in a manner that is effective 
in eliminating L. monocytogenes in RTE products. It should also be 
noted that FSIS replaced its Directive 10,240.2 in December 2002 with a 
new directive (10,240.3) with updated inspection verification 
activities. This new directive will be further revised to reflect the 
requirements of this interim final rule.

Inspection and Enforcement

    Comments: FSIS inspectors should be trained to understand Listeria 
testing and the evaluation of the testing results because the 
considerations involved are complex. FSIS should make compliance 
guidance materials available for industry review before final 
regulations take effect.
    Response: FSIS will be training its field inspection personnel to 
ensure that the interim final rule is properly implemented. FSIS's Food 
Safety Regulatory Essentials training, which addresses RTE products, is 
being given to all consumer safety inspectors. Regarding guidance 
materials, FSIS will provide comprehensive guidance to facilitate 
implementation of this interim final rule by all affected 
establishments. FSIS will make this guidance material available on its 
Web site well before this interim final rule takes effect.

Correlation Between Testing and Establishment Size and Production 
Volume

    Comments: There is no evidence that the testing frequencies 
proposed, which are based on establishment size, will lead to 
reductions in the rate of listeriosis.
    Also, requiring a large establishment to test more frequently than 
a small one because that establishment manufactured more product is not 
supportable. The Agency's preliminary economic impact analysis 
indicated that a small establishment could produce more product than a 
large establishment because factors other than employees were involved.
    Response: FSIS agrees that there is no necessary correspondence 
between

[[Page 34216]]

establishment size and the rate of listeriosis or the degree of risk 
posed by the products the establishment manufactures. This is one 
reason why the Agency is not adopting the food contact-surface testing 
frequencies it proposed. Instead, the Agency is allowing establishments 
flexibility in designing measures to address L. monocytogenes, 
including appropriate testing and hold-and-test strategies for their 
products.
    FSIS also understands that production volume does not necessarily 
correspond to establishment size. The Agency has concluded that having 
better and more comprehensive information about the production volume 
of RTE products will help it to more efficiently target its resources 
in verifying establishment L. monocytogenes controls.

Hold and Test

    Comments: Some commenters stated that requirements for 
establishments to hold and test product after initial positive tests 
from environmental sampling would be complicated and likely to result 
in errors. Such regulation would therefore prove ineffective.
    Other commenters insisted that, after an environmental positive, it 
would be appropriate for an establishment to follow hold-and-test 
procedures. They said that establishments should regard positive tests 
for Listeria from a non-food contact surface as indicating a sanitation 
or Listeria control problem and that if the positive test were from a 
food contact surface, all product from the shift represented by the 
sample should be held and tested before release.
    Response: FSIS proposed requirements for food contact-surface 
testing rather than tests from the general plant environment. In this 
interim final rule, with the exception of one provision, FSIS is 
allowing the industry flexibility in designing procedures to be carried 
out following positive tests for an indicator organism, such as 
Listeria species. However, if a product has been in contact with a food 
contact surface that has tested positive for L. monocytogenes, it is 
considered adulterated and must be withheld from commerce. FSIS 
believes that this flexibility should result in the adoption of hold-
and-test procedures that are not needlessly complicated and do not 
result in errors.

Costs and Benefits

    Comments: Some commenters stated that the proposed regulations that 
require establishments to hold and test product after positive 
environmental test results would impose significant costs that would be 
especially burdensome to small businesses. Further, it was asserted 
that establishments unable to hold product because of customer demand 
or lack of storage facilities would run the risk of incurring the costs 
associated with increased product recalls.
    Commenters argued that FSIS provided little justification for its 
Listeria testing policies in its proposal. They stated that it is 
difficult to estimate the number of listeriosis cases that might arise 
from contamination of meat and poultry products and discrepancies in 
the Agency's proposal illustrated this fact. For example, there is a 
significant data gap in the relationship between a product contact 
surface that tests positive for Listeria-like, Listeria species, and L. 
monocytogenes and whether the product will be positive and the risk to 
consumers. Commenters suggested that FSIS estimate the reductions in 
foodborne illness that would result from the regulation and provide 
further analysis or quantification of costs and benefits.
    Response: FSIS agrees that the proposed testing frequency 
requirements would not be without cost and is interested in ensuring 
the accuracy of its estimates. To this end, the Agency has accepted 
data that were submitted by several commenters on this matter and has 
used the data in preparing the final regulatory impact analysis.
    FSIS agrees that the costs associated with product recalls may far 
exceed those associated with hold-and-test procedures.
    On the effect of Listeria control regulations on small businesses, 
FSIS agrees that a relatively large proportion of small establishments 
will be affected by this interim final rule. FSIS has prepared 
compliance guidance for such establishments, including guidance 
specifically intended to assist them in HACCP plan validation with 
respect to L. monocytogenes control, and is making this guidance 
available with this interim final rule in the FSIS Docket Room and on 
the Agency's Web site. Also, FSIS will mail the guidance material to 
all RTE operations before the effective date of this interim final 
rule.
    FSIS agrees with the comments on the difficulties involved in 
determining the relationship between listeriosis cases and meat and 
poultry product contamination and with the suggestion that FSIS 
estimate the reductions in foodborne illness that could result from the 
regulation. FSIS initiated a risk assessment of in-plant processing of 
RTE products to determine the relationship between various food contact 
surface testing and sanitation regimes and other pre- and post-
packaging interventions in mitigating contamination of RTE products 
with L. monocytogenes and in reducing the subsequent risk of illness or 
death and has further analyzed the costs and benefits. FSIS considered 
the results of the risk assessment in developing this interim final 
rule. In the final regulatory impact analysis, the Agency analyzes the 
effect of the interim final rule in terms of the reduction of illness 
and death from listeriosis.

Definition of RTE and Relative Risk of Different RTE Products

    Comments: Commenters expressed concern about the terminology that 
the Agency used in its proposal. These concerns were related to the 
scope and effects of the regulation. The commenters said that FSIS 
should more clearly define RTE products. Some of them stated that 
frozen products ought not to be considered RTE for the purposes of the 
rule. To include such products in the RTE category, they argued, would 
be contrary to previous FSIS policy (Agency directives), the FDA's 
model food code, and the FDA/FSIS risk ranking model for Listeria in 
RTE foods. The commenters argued that another category of products, 
dried meat and fermented products, also should not be considered RTE 
for the purposes of the rule, for their water activity (aw) 
puts them at low risk as a medium for growth of L. monocytogenes.
    The commenters suggested that instead FSIS should define RTE 
products as ``refrigerated foods of extended shelf life (10 
days) that can support the growth of L. monocytogenes and that will be 
consumed without further listericidal treatment.'' The commenters added 
that FSIS should base L. monocytogenes control requirements on risks 
posed by specific types of products.
    Response: The Agency has revised the definition of RTE to be 
consistent with the definition of RTE used in the 2001 Food Code. FSIS 
does not believe that frozen foods, as a broad category, can be 
excluded from the definition of RTE for this rule. Rather, the Agency 
will continue to follow its existing practice of determining whether 
foods should be considered RTE because of the manner of processing and 
the handling instructions provided to consumers. Some instructions 
direct that the product must receive further preparation for safety 
purposes.
    Several labeling features or statements are used exclusively on RTE 
products or non-RTE products, but not on both. RTE products often 
include phrases indicating that they do not require

[[Page 34217]]

further preparation for safety, i.e., ``fully cooked,'' ``Ready-to-
eat,'' and ``Heat and Serve.'' Features that are used exclusively on 
non-RTE products to inform consumers that the products must be cooked 
to be safe for consumption include the Safe Handling Instructions, 
which indicate that the meat or poultry portion have not received an 
adequate lethality treatment and such phrases as, ``Raw,'' 
``Uncooked,'' ``Not Ready-to-Eat,'' and ``Ready-to-Cook.''
    Cooking instructions alone, however, are not a reliable labeling 
feature for consumers to determine whether a product requires cooking 
for safety. Phrases such as ``Cook and Serve,'' ``See cooking 
instructions,'' and ``Cook thoroughly'' have been used interchangeably 
on both RTE and NRTE meat and poultry products.
    FSIS will continue to consider frozen foods that provide clear 
instructions to consumers about safe handling and cooking requirements 
as not-RTE and therefore not subject to this regulation. Frozen 
products that do not meet these requirements will be considered RTE.
    The Agency does not agree that either frozen foods or dried meat 
and fermented products should be excluded from the definition just 
because they pose a low risk for L. monocytogenes. In both cases, the 
products are lower in risk because they have undergone a process that 
is either lethal to or suppresses or limits the growth of pathogens, 
including L. monocytogenes. For this reason, FSIS believes that 
establishments producing these products should also be required to 
incorporate in their operations measures addressing L. monocytogenes to 
ensure that the products can be consumed safely without further 
preparation.

Tolerance for L. monocytogenes and Food Safety Objectives (FSO's)

    Comments: Some commenters recommended that FSIS establish a 
tolerance for L. monocytogenes in certain products that do not support 
growth of the organism. The commenters suggested that a FSO would be 
consistent with the concepts favored by the Codex Alimentarius 
Commission and the standards applied by some of this Nation's trading 
partners. A more rigorous standard could be applied to product that is 
intended for vulnerable populations.
    Response: Establishing a tolerance for L. monocytogenes is outside 
the scope of this rulemaking. The Agency is not in a position to set a 
regulatory tolerance for L. monocytogenes in RTE products, for a number 
of reasons, including the fact that the Agency is unable routinely to 
identify the end users of the products.
    Absent a conclusive demonstration to the contrary, the Agency must 
regard any amount of L. monocytogenes in a RTE product as an adulterant 
under the FMIA or PPIA (21 U.S.C. 601(m), 453(g)).

Labeling and Consumer Education

    Comments: Some commenters said that development of meaningful 
``use-by'' dating that reflects the safety of the product is a 
practical impossibility. They said that ``use-by'' dates would only be 
effective for products that are ``refrigerated foods of extended shelf 
life (10 days) that can support the growth of L. 
monocytogenes and that will be consumed without further listericidal 
treatment.''
    Other commenters maintained that FSIS should require RTE products 
to have a uniform expiration dating system to identify product that 
should be frozen or not consumed after a specified number of days. Some 
commenters said that RTE products should carry warning labels if they 
are produced by a plant that does not conduct product testing for L. 
monocytogenes as a feature of its HACCP system. Also, they said, 
because of the possibility that RTE products might be contaminated with 
L. monocytogenes, the products should carry safe-handling labels until 
testing is required.
    Response: FSIS proposed some revisions to the special-handling 
label requirements that are not addressed in this interim final rule. 
The Agency did not propose use-by labeling but requested comment on the 
feasibility of requiring such labeling, including the most effective 
way to implement it, the assumptions retailers and consumers should be 
expected to make in using it, scientific and economic data on the 
shelf-life and safety of RTE meat and poultry products, the kinds of 
post-lethality interventions that should be expected for products 
bearing use-by labeling, and the content of the labeling (66 FR 12635). 
FSIS notes that the National Advisory Committee on Microbiological 
Criteria for Foods (NACMCF) is currently addressing safety-based use-by 
dates. FSIS will consider the NACMCF findings and other information of 
the kind requested in the proposal before any further rulemaking on the 
issue.

VII. The Interim Final Rule: Control of L. monocytogenes

    FSIS has considered the information presented in comments on the 
proposal, public meetings, the FDA/FSIS risk ranking, and the FSIS risk 
assessment. Given the pathogenicity of L. monocytogenes, the 
opportunity for it to contaminate RTE product in the post-lethality 
environment, and the significant consequences that this contamination 
can have, FSIS is amending its regulations. The Agency is adding 
provisions that require establishments that produce post-lethality 
exposed RTE product to include in their HACCP plans or in their 
Sanitation SOPs or other prerequisite programs measures that prevent 
product adulteration by L. monocytogenes.
    FSIS is adding several definitions (9 CFR 430.1) to the 
regulations. FSIS is defining ``deli product'' and ``hotdog product,'' 
which are a particular focus of the regulations because of the risks 
they pose. The Agency is also adding several definitions relating to 
conditions affecting RTE products after the products have undergone a 
process that destroys L. monocytogenes (9 CFR 430.1).
    The first definition in 9 CFR 430.1 is for ``antimicrobial agent,'' 
which FSIS is defining to mean a substance in or added to an RTE 
product that has the effect of reducing or eliminating a microorganism 
or of suppressing or limiting its growth throughout the shelf life of 
the product. In the context of this regulation, an antimicrobial agent 
may be added to a post-lethality exposed product (also defined) after 
its initial lethality treatment. An antimicrobial agent, such as acid 
from fermentation, may also be an inherent component of the product or 
a result of its formulation. In any case, the effect of the use of the 
antimicrobial agent is to limit or suppress growth of L. monocytogenes.
    ``Antimicrobial process'' is defined to mean an operation, such as 
freezing, that is applied to an RTE product and that has the effect of 
suppressing or limiting the growth of a microorganism. In the context 
of this regulation, the process is typically applied to a post-
lethality exposed product after its initial lethality treatment, and 
the effect of the process in limiting or suppressing growth of L. 
monocytogenes continues throughout the shelf life of the product. If a 
product were frozen, the effect of freezing the product could only 
continue throughout the shelf life of the product if the product were 
maintained continuously in a frozen state.
    The Agency is defining ``post-lethality exposed product'' as RTE 
product that comes into direct contact with a food contact surface 
after undergoing a lethality treatment that is a usual and necessary 
step in the production of the product, e.g., the cooking step for a 
hotdog or other cooked sausage. A

[[Page 34218]]

definition of ``lethality treatment'' is provided. The ``post-lethality 
processing environment'' is defined as the area of an establishment 
into which product is routed after undergoing a lethality treatment.
    ``Post-lethality treatment'' is defined as a lethality treatment 
applied to a product after post-lethality exposure. A post-lethality 
treatment might be an additional heat step or other pasteurization 
process, such as high-pressure processing. A ``post-lethality 
treatment'' to reduce or eliminate L. monocytogenes is to be 
distinguished from the use of an antimicrobial agent or process that 
suppresses or limits the growth of the pathogen. Antimicrobial agents 
include lactic acid in certain types of sausage products or ingredients 
of growth-limiting packaging (e.g., cellulose containing an 
antimicrobial substance). An example of a growth suppressing or 
limiting process is freezing.
    FSIS is defining ``prerequisite program'' as a procedure or set of 
procedures designed to provide the basic environmental or operating 
conditions necessary for the production of safe, wholesome food. The 
definition is adapted from ``Hazard Analysis and Critical Control Point 
Principles and Application Guidelines,'' which was adopted August 14, 
1997, by the National Advisory Committee on Microbiological Criteria 
for Foods and has wide currency in the food industry. Prerequisite 
programs are a part of the decision-making documentation that is 
associated with the hazard identification and selection of CCPs in a 
HACCP plan. An establishment is required by 9 CFR 417.5 to maintain 
such documentation because the existence of an effective Sanitation SOP 
or other prerequisite program affects the outcome of an establishment's 
hazard analysis.
    The definition of a ``prerequisite program'' is being provided, and 
the use of such a program in the new regulations is being permitted, in 
response to industry comments on the proposal emphasizing the 
importance of prerequisite programs in preventing L. monocytogenes 
contamination. One commenter stated that post-processing contamination 
by L. monocytogenes is best controlled through prerequisite programs.
    Finally, FSIS is adopting the definition of a ``ready-to-eat'' 
product that, although similar to the one proposed, conforms with the 
2001 Model Food Code. Thus, an RTE meat or poultry product is one that 
is ``in a form that is edible without additional preparation to achieve 
food safety and may receive additional preparation for palatability or 
aesthetic, epicurean, gastronomic, or culinary purposes.''
    In a new section on control of L. monocytogenes in post-lethality 
exposed RTE products, 9 CFR 430.4, FSIS first states its basic finding 
that L. monocytogenes is a hazard in such products, and that 
establishments must control this hazard through their HACCP plans or 
prevent it in the processing environment through Sanitation SOPs or 
other prerequisite programs. FSIS is making this finding, as it states 
in 9 CFR 430.4(a), based on the fact that RTE products that have been 
subjected to a lethality treatment but then exposed to the environment 
may be recontaminated with L. monocytogenes.
    An establishment may determine that recontamination is not 
reasonably likely to occur in its post-lethality exposed RTE products 
because it has an effective Sanitation SOP or some other prerequisite 
program that effectively prevents L. monocytogenes contamination. If an 
establishment makes this determination, under 9 CFR 417.5(a)(2), the 
regulation requiring establishments to keep documentation supporting 
the selection of CCPs or critical limits, the basis for this 
determination must be documented and made available to the Agency. FSIS 
is aware that, in their hazard analyses, establishments have been 
taking their Sanitation SOPs and other prerequisite programs into 
consideration. Thus, an establishment that produces RTE products may 
not identify L. monocytogenes as such a hazard to be addressed in its 
HACCP plan, it must nonetheless effectively address this pathogen in 
its food safety system.
    The Agency is requiring, in 9 CFR 430.4(b), that an establishment 
that produces post-lethality exposed RTE product must meet the specific 
requirements of one of three alternative programs for addressing L. 
monocytogenes. In the view of FSIS, any situation involving 
establishment measures to address post-lethality contamination of RTE 
products by L. monocytogenes is covered by one of the alternatives. 
Under this interim final rule, the first alternative relies largely on 
control though HACCP and an antimicrobial agent or process that 
suppresses or limits the growth of the pathogen. Each successive 
alternative places a greater reliance on the rigor of sanitation 
procedures, including verification testing, than on post-lethality 
treatments, to control L. monocytogenes. Consequently, the frequency 
and intensity of FSIS verification is likely to be greater for 
Alternatives 2 and 3, as more reliance is placed on sanitation.
    Alternative 1. In the first alternative, an establishment controls 
L. monocytogenes by using a post-lethality treatment of the product and 
an antimicrobial agent or process that suppresses or limits the growth 
of the pathogen. As mentioned previously, the use of the post-lethality 
treatment to reduce or eliminate L. monocytogenes reflects a 
determination that the pathogen may be present in the product--in other 
words, that it is a hazard reasonably likely to occur. Therefore, the 
establishment must include the post-lethality treatment in its HACCP 
plan. The point in the process at which the treatment is applied is, by 
definition, a ``critical control point'' under 9 CFR 417.1 in that it 
is a step in a process at which control is applied to prevent, 
eliminate, or reduce to acceptable levels a food safety hazard, L. 
monocytogenes. The post-lethality treatment incorporated in the HACCP 
plan must be validated in accordance with 9 CFR 417.4 as being 
effective in reducing or eliminating L. monocytogenes.
    The use of an antimicrobial agent or growth suppressing or limiting 
process may not in practice have the L. monocytogenes reduction effect 
of a post-lethality treatment, but still be an effective measure 
because it inhibits growth of the pathogen, thus, limiting the 
possibility that any L. monocytogenes that survives the post-lethality 
treatment will grow out and presents a food safety hazard. In 
Alternative 1, FSIS is giving the establishment the choice of including 
the antimicrobial agent or process in its Sanitation SOP or other 
prerequisite program or as a CCP in its HACCP plan.
    FSIS recognizes that an establishment electing to adopt Alternative 
1 may employ an antimicrobial agent or process as part of its initial 
lethality treatment and that the agent or process may have a continuing 
bactericidal effect on L. monocytogenes that persists even through 
post-lethality exposure and distribution. In such a case, the 
antimicrobial agent or process could serve as both a post-lethality 
treatment and growth inhibitor. Thus, neither an additional post-
lethality treatment nor an additional antimicrobial agent or process is 
necessary to qualify for Alternative 1. The establishment would need to 
have documentation on file to demonstrate that the conditions of 
Alternative 1 are being met through the application of the initial 
antimicrobial agent or process.
    As with the post-lethality treatment, if the antimicrobial agent or 
process is

[[Page 34219]]

included as a CCP in the HACCP plan, it must be validated as effective 
in suppressing or limiting growth of the pathogen. The establishment 
must also verify the effectiveness of the control measures in 
accordance with 9 CFR 417.4. If the agent or process is included in the 
establishment's sanitation program, it must be in compliance with the 
general sanitation regulations and the Sanitation SOP requirements in 9 
CFR part 416. The control measures, if included in the HACCP plan, must 
be validated as effective. The establishment's regular monitoring of 
its operation must be verified. Sanitation procedures must be in 
compliance with the general sanitation regulations and the Sanitation 
SOP requirements, as applicable.
    In addition, the establishment is required to make the results of 
its verification measures, under whichever program--HACCP, Sanitation 
SOP, or other prerequisite program--available upon request to FSIS 
inspection personnel.
    FSIS has concluded, and this conclusion is informed by the FSIS 
risk assessment, that Alternative 1, which involves a combination of 
interventions that includes a post-lethality treatment and the 
application of an antimicrobial agent or process, is likely to be among 
the most effective means of reducing the risk of L. monocytogenes 
contamination and hence of listeriosis mortality among vulnerable 
populations.
    Alternative 2. An establishment may choose to address L. 
monocytogenes by using a post-lethality treatment or an antimicrobial 
agent or process that suppresses or limits the growth of the pathogen. 
As with Alternative 1, the post-lethality treatment, if used, must be 
included as a CCP in the establishment's HACCP plan. The application of 
the antimicrobial agent or the growth suppressing or limiting process 
must be included in the establishment's HACCP plan or in its Sanitation 
SOP or other prerequisite program. Whichever program includes the 
application of the antimicrobial agent or the growth suppressing or 
limiting process, the establishment must have documentation to 
demonstrate that the antimicrobial agent or process, as used, is 
effective in suppressing or limiting the growth of L. monocytogenes.
    In addition, FSIS is providing that if the establishment chooses 
Alternative 2 and chooses to use only a post-lethality treatment of 
product, it would likely be subject to more frequent verification 
testing than if it chose Alternative 1. FSIS has concluded that 
multiple steps are more likely to reduce the risk of L. monocytogenes 
contamination of RTE products and subsequent adverse public health 
effects. Without an antimicrobial to suppress or limit the growth of L. 
monocytogenes that may survive the post-lethality treatment, it becomes 
more important to verify the effectiveness of that treatment.
    The establishment may choose not to rely on a post-lethality 
treatment to reduce or eliminate L. monocytogenes, but to use only an 
antimicrobial agent or process that suppresses or limits the growth of 
L. monocytogenes. If so, it becomes extremely important to minimize any 
possibility of post-lethality contamination. The establishment's 
sanitation program must, therefore, provide for the testing of food 
contact surfaces in the post-lethality processing environment to ensure 
that the establishment's sanitation program is effective in keeping 
those surfaces sanitary and free of L. monocytogenes or of indicator 
organisms that would reflect the presence of L. monocytogenes. The 
program must delineate the frequency with which testing will be done, 
state the size and location of the sample sites (so that the area 
represented by a sample can be known), and provide an explanation of 
why the testing frequency is sufficient to ensure that effective 
control of L. monocytogenes or the indicator organism is being 
maintained. The program also must identify the conditions under which 
the establishment will implement hold-and-test procedures after a 
positive test for L. monocytogenes or indicator organisms.
    As under the Alternative 1, the establishment must make the 
verification results of the effectiveness of its controls from its 
HACCP, Sanitation SOP, or other prerequisite program available upon 
request to FSIS inspection personnel.
    For Alternative 2, if the measures for addressing L. monocytogenes 
are in a prerequisite program other than a Sanitation SOP, the 
establishment must ensure that the program is effective and does not 
cause the hazard analysis or the HACCP plan to be inadequate. The 
establishment's documentation of its program and of its results and its 
implementation of the program must be sufficient to support a finding, 
during validation or reassessment, under 9 CFR 417.4, that the HACCP 
plan is adequate and that the HACCP plan in operation is not inadequate 
within the meaning of 9 CFR 417.
    Alternative 3. An establishment that processes RTE products may 
control L. monocytogenes in the post-lethality processing environment 
through sanitation procedures only. If incorporated in the HACCP plan, 
the sanitation procedures followed in this alternative must be 
validated and verified in accordance with 9 CFR 417.4. Also, sanitation 
in the post-lethality processing area must be maintained in accordance 
with 9 CFR 416.
    As in Alternative 2, FSIS is requiring that the sanitation 
procedures in the post-lethality processing environment include testing 
of food contact surfaces to ensure that the surfaces are sanitary and 
free of L. monocytogenes or an indicator organism. The procedures must 
delineate the frequency of testing; state the size and location of 
sample sites; and provide an explanation of why the testing is 
sufficient to ensure that the establishment's sanitation procedures are 
effectively keeping L. monocytogenes or indicator organisms from 
contaminating product. The establishment must identify in its 
procedures the conditions under which it will implement hold-and-test 
procedures to ensure that L. monocytogenes or indicator organisms are 
not contaminating product.
    Establishments that adopt Alternative 3 will need to address in 
their decisionmaking documents why the sanitation procedures they 
employ, the frequency of testing they carry out, and the circumstances 
in which they test the product and hold it pending receipt of test 
results are appropriate and adequate to prevent the contamination of 
their product by L. monocytogenes and to ensure that contamination is 
discovered if it has occurred.
    Because establishments using Alternative 3 are relying only on 
sanitation procedures and because verification activities are so 
important to ensuring the on-going effectiveness of such measures, FSIS 
has concluded that establishments electing to adopt Alternative 3 are 
likely to be subject to a higher frequency of testing by FSIS than 
establishments using Alternative 1 or 2. As is the case with 
establishments adopting the other alternatives, an establishment that 
has adopted Alternative 3 must make the verification results obtained 
from its own food contact surface testing available on request to FSIS 
inspection personnel.
    Under Alternative 3, more stringent requirements apply to an 
establishment that processes deli meats or hotdogs. These products were 
shown in the FDA/FSIS risk ranking to pose a relatively high risk of 
listeriosis, in terms of cases per annum. Thus, in order to provide the 
assurance that comes from increased verification, FSIS expects the 
frequency of its own testing, as well as the establishment's testing, 
to be higher

[[Page 34220]]

than that for other products produced under the Alternative 3 approach.
    Under Alternative 3, for establishments producing deli meats and 
hotdogs, FSIS is requiring specific procedures for holding and testing 
product to minimize the risk of contaminated product entering commerce. 
These procedures are to be followed if an establishment has had a 
positive test for an indicator organism, such as Listeria species, on a 
food contact surface in the post-lethality processing environment.
    After the establishment takes corrective action to clean the food 
contact surface, the establishment must verify that the corrective 
action has been effective through follow-up testing in the post-
lethality processing area. This testing is to include targeting the 
specific site on the food contact surface area that was the most likely 
source of contamination by the organism and must include such 
additional tests of the surrounding food contact surface area as are 
necessary to ensure the effectiveness of the corrective action. (If the 
initial positive test was for L. monocytogenes, the product is 
considered adulterated and must be withheld from commerce even before 
the results of further testing are available.)
    If, during this follow-up testing, the establishment obtains a 
second positive test result for the indicator organism on a sample from 
the previously tested area, the establishment must hold lots of product 
produced between the second positive test result and completion of the 
corrective action until samples from the food contact surfaces in the 
same area test negative for L. monocytogenes or the indicator organism. 
The establishment may sample and test the held product, using a 
sampling method that will provide a level of statistical confidence 
that is sufficient to establish that the product is not adulterated 
with L. monocytogenes, and it can release the product into commerce if 
the results are negative.
    For Alternative 3, if the measures for addressing L. monocytogenes 
are in a prerequisite program other than a Sanitation SOP, the 
establishment must ensure that the program is effective and does not 
cause the hazard analysis or the HACCP plan to be inadequate. The 
establishment's documentation of its program and of its results and its 
implementation of the program must be sufficient to support a finding, 
during validation or reassessment, under 9 CFR 417.4, that the HACCP 
plan is adequate and that the HACCP plan in operation is not inadequate 
within the meaning of 9 CFR 417 part 1.
    Estimates of annual production volume. As previously stated in this 
document, some commenters observed that a large establishment may not 
necessarily produce more RTE product than a small establishment. FSIS 
agrees and regards production volume as a more important risk factor 
than establishment size. FSIS intends to target its inspection 
resources on the higher volume operations. To do this effectively, FSIS 
will need data on the annual production volume of post-lethality 
exposed RTE products produced, by product, and by L. monocytogenes 
control alternative (1, 2, or 3), and other related information (such 
as the establishment's own testing procedures). The affected 
establishments will have to provide FSIS with this information at least 
annually. The Agency expects to have an electronic form available for 
this purpose (9 CFR 430.4(f)).

Labeling Incentive

    Finally, FSIS is allowing establishments that use post-lethality 
treatments or antimicrobial agents or processes that are effective in 
destroying L. monocytogenes or in limiting its growth to declare this 
fact on the labels of their products. The purpose of the labeling is to 
inform consumers about measures that have been taken to ensure the 
safety of the products and thus to enable the consumers to select such 
products in preference to others. This provision is entirely voluntary, 
but FSIS believes that labeling claims about treatments that eliminate, 
suppress, or limit the growth of L. monocytogenes can be of value to 
consumers, especially those in groups most vulnerable to foodborne 
infection.
    For example, products with antimicrobial agents can be viewed as 
containing substances that reduce the presence of pathogens or the 
likelihood of foodborne illness, provided that the products are 
appropriately handled throughout the distribution chain and prepared 
safely by the consumer. Thus, a label statement should identify the 
presence of ingredients and their purpose of use but not claim that the 
product is somehow ``safer than'' other untreated products.
    Examples of statements that can be made are: ``Sprayed with a 
solution of sodium lactate to prevent the growth of L. monocytogenes'' 
or ``Contains sodium diacetate and sodium lactate to prevent the growth 
of Listeria monocytogenes.''

New and Existing Regulatory Requirements

    The regulations promulgated in this interim final rule include new 
requirements and reiterate for clarity certain existing regulations. 
The definitions in Sec.  430.1 are new, as are the provisions in Sec.  
430.4 specifying the three permissible alternatives for addressing L. 
monocytogenes. Similarly, the provisions in this interim final rule 
requiring that measures included in the establishment's Sanitation SOP 
or other prerequisite program are new. The provision requiring that RTE 
establishments report at least annually the volume of production by 
type of RTE product and by alternative for controlling or addressing L. 
monocytogenes is new. Also new are the sanitation procedure 
requirements that include hold-and-test provisions.
    Although the use by industry and the Agency's acceptance of 
prerequisite programs is not new, the provisions on prerequisite 
programs in this interim final rule constitute explicit recognition, 
for the first time in the codified regulations, of such programs. The 
requirement that documentation of prerequisite programs and the results 
of such programs be available to the Agency also makes explicit an 
implied requirement in the HACCP regulations.
    Also, the requirement that a post-lethality treatment be included 
in an establishment's HACCP plan is made explicit for the first time in 
this interim final rule. The requirement to maintain documentation on 
Sanitation SOPs or other prerequisite programs that are used to support 
a decision not to identify L. monocytogenes as a hazard reasonably 
likely to occur that must be controlled makes explicit a requirement in 
the HACCP regulations (9 CFR 417.5). The provision for validation of 
controls included in a HACCP plan just reiterates existing requirements 
of 9 CFR 417.4. Similarly, the requirement that Sanitation SOPs be 
evaluated routinely to ensure their effectiveness reiterates the 
requirements in 9 CFR 416.14.
    The requirement to verify, that is, to evaluate routinely and 
maintain, the effectiveness of the Sanitation SOP, is already a 
regulation (at 9 CFR 416.14). Also, the requirement to follow existing 
sanitation requirements in the post-lethality processing environment 
simply reiterates the general sanitation regulations (9 CFR 416) that 
are applicable everywhere in an official establishment.
    Finally, the provision for RTE product labeling that declares the 
fact of an L. monocytogenes control treatment or ingredient is new, but 
permissive. RTE product labeling may, under current regulations, bear 
such statements if the statements are valid.

[[Page 34221]]

VIII. Implementation

Implementation Strategy

    FSIS has designed this interim final rule to recognize that there 
are alternative, effective ways to ensure that post-lethality exposed 
RTE products do not become contaminated with L. monocytogenes. While 
each approach can be effective in preventing such contamination, 
Alternatives 1 and 2 present a greater opportunity for mitigating the 
risk of RTE product contamination than does Alternative 3 because under 
Alternatives 1 and 2, products are formulated or processed in a manner 
either to eliminate L. monocytogenes or to limit its growth, should it 
be present.
    Hence, in implementing this interim final rule, FSIS plans to 
conduct verification activities, including testing, that focus most 
intensively on Alternative 3 establishments and, within that group, on 
establishments that produce deli meats and hotdogs to verify that the 
total food safety system under which these products are produced is 
working properly.
    FSIS is aware that the regulated industry is using antimicrobial 
agents at levels that provide some limitation of growth, that some 
establishments use these agents at levels that allow no more than 2-
log10 growth throughout the shelf-life of the product, and 
that other establishments are using the agents at levels that more 
severely limit growth. FSIS believes that the majority of products 
formulated with the higher levels of antimicrobial agents are cured 
products because they better tolerate the agents, and the products do 
not have unacceptable organoleptic qualities. For this reason, the FSIS 
verification testing program for Alternative 2 will cover 
establishments that produce products formulated with antimicrobial 
agents but will focus on establishments using lower levels of 
antimicrobial agents because there is some potential for pathogen 
growth in the products. However, FSIS does not intend to conduct its 
verification testing at such establishments at a rate that is any 
higher than that for establishments in Alternative 3 and certainly not 
at a rate as high as that for establishments using Alternative 3 and 
producing deli meats or hotdogs.
    FSIS intends to collect information about the RTE products produced 
by establishments using Alternatives 1 through 3. The information will 
include estimates of production volume for post-lethality exposed 
products, so that the Agency can develop annual sampling frequencies 
for the establishments and the products. FSIS will make the sampling 
frequency information available to the establishments so that they will 
have some indication of how the risk of L. monocytogenes contamination 
is tied to FSIS verification testing.
    FSIS is continuing to model scenarios in its risk assessment model 
and will use this information in determining where to direct its 
verification testing resources to ensure that such products are not 
adulterated. In the meantime, FSIS will continue to use currently 
available production volume figures in directing these resources.
    The Agency expects to weight its sample scheduling process so that 
a large-volume establishment will be targeted more frequently than an 
establishment with a lower volume of production. Because, under this 
interim final rule, all establishments must have written programs that 
address Listeria and share their testing results with FSIS, FSIS 
believes that there will be no need to phase in the implementation of 
the interim final rule for establishments of different sizes or of 
different production volume capacity. The effective date will be 
October 6, 2003, for all establishments. During the 120 days before the 
interim final rule becomes effective, FSIS will issue a new directive 
(Directive 10,240.4, discussed below). The Agency is now making 
available new compliance guidelines that will contain information about 
the effects of sanitation and testing, as well as the effectiveness of 
various levels of antimicrobials.

New Directive for FSIS Inspection Program Employees

    Through a new directive replacing FSIS Directive 10,240.3 that 
issued in December 2002, FSIS will conduct a risk-based verification 
testing program to assess the effectiveness of RTE operations in 
controlling L. monocytogenes. FSIS will identify the general features 
of the design of its verification testing program. Each fiscal year, 
FSIS identifies the general number of samples that it expects to 
collect throughout the year associated with RTE products. In order to 
implement this interim final rule, FSIS expects to apportion the types 
of products sampled with an emphasis on deli meats and hotdogs produced 
under Alternative 3. All RTE products are subject to being tested.
    Until FSIS has actual production volume and associated data 
obtained through the reports required by 9 CFR 430.4(f), FSIS likely 
will continue sampling in the same manner currently employed by the 
Agency. FSIS intends to build in the production volume feature, as soon 
as possible, in order to ensure that larger volume production is 
verified more frequently than smaller volume production. In addition, 
FSIS will continue to assess information about sanitation non-
compliances and other plant performance indicators when determining 
which operations should be tested, but with an emphasis on products 
that allow for growth of L. monocytogenes.
    As FSIS obtains information on the effectiveness of establishment 
process controls for L. monocytogenes, the Agency should be able to 
reduce the intensiveness of verification testing at establishments with 
more effective controls.
    Generally, FSIS expects to collect for L. monocytogenes testing 
just one sample unit of RTE product from a production lot at an 
establishment selected for sampling. FSIS is considering taking more 
than one product sample from an establishment that produces product 
without post-lethality treatments or growth inhibitors, particularly 
deli meat and hotdog operations. Finally, FSIS expects to collect food 
contact surface samples and environmental samples mainly from 
operations that have a history of problems associated with the proper 
control for L. monocytogenes, or that produce RTE products, 
particularly deli meats and hotdogs, that allow for the growth of L. 
monocytogenes.

IX. Consumer Outreach Effort

    Food safety education is one risk management strategy FSIS uses to 
reduce the incidence of illness associated with L. monocytogenes in RTE 
meat and poultry products. Safe handling, storage and preparation of 
RTE meat and poultry products can help reduce the risk of illness, 
particularly for those populations most at risk of contracting 
listeriosis: pregnant women, newborns, older adults, people with 
weakened immune systems caused by cancer treatment, AIDS, diabetes, 
kidney disease, and organ transplants. FSIS reaches these audiences 
through printed materials, the FSIS Web site, electronic communication, 
the media, and other information multipliers, in collaboration with 
other Federal agencies, educators, and healthcare professionals, and 
through the USDA Meat and Poultry Hotline.
    For example, FSIS has worked with the Association of Women's 
Health, Obstetric and Neonatal Nurses, the International Food 
Information Council Foundation, FDA, and CDC to produce a patient 
education sheet, ``Listeriosis and Pregnancy: What is Your Risk?'' 
targeted to both pregnant women and

[[Page 34222]]

their healthcare providers. The Spanish version will be printed in 
spring 2003. In addition, FSIS is completing a low literacy flyer aimed 
at pregnant women entitled, ``Protect Your Baby and Yourself from 
Listeriosis'' with input from WIC nutritionists, public health nurses, 
and extension food safety specialists. To reach other vulnerable 
groups, discussions are underway with transplant organizations, 
community health clinics, geriatric organizations, dialysis centers, 
and AIDS/HIV care organizations to determine how best to reach these 
individuals. Through the newly launched Food Safety Education Mobile, 
informational materials will be distributed as the vehicle travels 
throughout the country.
    In addition to providing education on safe food handling, FSIS will 
provide information to consumers regarding new labels that processors 
may voluntarily use under this regulation to inform consumers of 
interventions used to reduce contamination.

X. Executive Order 12866 and Effect on Small Entities

    This interim final rule has been reviewed by the Office of 
Management and Budget under E.O. 12866 and has been determined to be 
economically significant. FSIS is amending the Federal meat and poultry 
inspection regulations by adding requirements for establishments that 
produce certain RTE meat and poultry products to take measures to 
prevent product adulteration by the pathogen L. monocytogenes. 
Establishments that produce RTE meat and poultry products that are 
exposed to the environment after lethality treatments must include in 
their HACCP plans or their Sanitation SOPs or other prerequisite 
programs measures designed to prevent product adulteration by L. 
monocytogenes. The establishments also must share with FSIS all data 
relevant to the validation, operation, and verification of their 
controls for L. monocytogenes.
    This action is compelled by outbreaks of foodborne illness in which 
RTE meat and poultry products contaminated with L. monocytogenes were 
implicated, coupled with information on the pathogenicity of the 
organism and the findings of the risk assessment and risk ranking 
conducted by FDA and FSIS. Although FSIS now routinely conducts food 
contact surface and environmental sampling in select establishments 
that produce such products, and performs product testing in nearly all 
RTE establishments for the presence of this pathogen before the 
products are distributed, until now there have been no specific 
regulatory requirements for controlling the pathogen. Appendix A, 
published at the end of this interim final rule in this issue of the 
Federal Register, contains the final regulatory analysis required by 
E.O. 12866 and the Regulatory Flexibility Act (at 5 U.S.C. 604), 
including a discussion of the need for the regulations, regulatory 
alternatives considered by FSIS, and a cost-benefit analysis. This 
interim final rule provides affected small and very small 
establishments with the flexibility to minimize the costs associated 
with this rule by implementing Sanitation SOPs or other prerequisite 
programs. FSIS is providing compliance guidance for these 
establishments in accordance with the Small Business Regulatory 
Enforcement Fairness Act. In addition, in verifying compliance with 
this interim final rule, the Agency plans to conduct testing at 
modulated frequencies, taking into account all relevant factors, 
including the alternative employed to address L. monocytogenes, 
production volume by type of RTE product produced, and the 
establishment's compliance history.

Summary of Final Regulatory Impact Analysis (FRIA)

Benefits
    FSIS has estimated the benefits of this interim final rule in terms 
of averted deaths and illnesses resulting from actions taken by 
establishments that produce RTE meat and poultry products so far with 
respect to only one product group: Deli meats. FSIS has concentrated on 
this product group for several reasons: The FDA/FSIS risk ranking 
identified deli meats as posing the most overall risk to public health. 
The FSIS in-plant risk assessment tied risk mitigation actions to 
possible reductions in deaths and illnesses from listeriosis when the 
FSIS risk assessment model was calibrated with the FDA/FSIS risk 
ranking model, and when containment strategies for Listeria 
contamination of RTE meat and poultry products were simulated. The FSIS 
risk assessment model has been presented to the public, along with 
estimates of reduced listeriosis mortality resulting from actions taken 
by establishments that prepare or process the products.
    The FRIA relies on results from the FSIS in-plant risk assessment 
model and considers the adoption by large, small, and very small deli-
meat producing establishments of stratagems of varying rigor for 
controlling L. monocytogenes. The analysis shows that adoption of L. 
monocytogenes mitigation measures induced by this interim final rule 
results in a total median reduction of deaths from listeriosis of 27.3; 
with 8.9 deaths averted at the 5th percentile and 31.2 at the 95th 
percentile. These gains are attributable to an expected shift--
discussed in detail in Appendix A--of establishments from sanitation-
only to ``Alternative 1'' and ``Alternative 2'' methods of addressing 
L. monocytogenes. The corresponding reductions in illnesses are 136.7 
at the median, with 44.6 at the 5th percentile, and 156.0 at the 95th 
percentile.
    Using a method used by USDA's Economic Research Service (ERS) for 
estimating the human health benefits of reduced listeriosis, the 
benefits of the reduction in illness-related losses due to the interim 
final rule are estimated to be $3.7 million at the median ((.05 x 136.7 
x $10,300) + (.95 x 136.7 x $28,300)) and $1.3 million at the 5th and 
$4.4 million at the 95th percentile.
    ERS estimated the value of statistical life at $4.8 million \7\ as 
a proxy for the cost of one fatality. Based on this estimate, the 
annual human health benefits from implementation of the interim final 
rule are $134.9 million at the median (the $3.7 million above plus 27.3 
x $4.8 million) and $44.0 million at the 5th percentile and $154.0 
million at the 95th percentile.
    Given the limitations in data and the fact that the risk assessment 
addresses only deli meats, FSIS believes that this estimate may be 
overstated by at least 50 percent. If so, the adjusted annual net 
benefits then become $50.8 million at the median, $5.4 million at the 
5th percentile, and $60.4 million at the 95th percentile. FSIS 
performed a sensitivity analysis on the benefits estimates. Given the 
cost estimates, the total benefits of this rule would have to be 85 
percent lower than estimated for the net benefits to lower to zero.
Cost Impacts
    FSIS estimated the cost impacts of this interim final rule on all 
affected establishments. The FRIA adds several cost impacts in addition 
to those considered in the preliminary regulatory impact analysis 
(PRIA). The PRIA identified major cost impacts from mandatory food 
contact surface testing, HACCP plan modification, and production 
adjustments. In addition to these and in response to comments, the FRIA 
considers the costs, both fixed and recurring, associated with the 
installation by establishments of post-lethality treatments; the costs, 
both fixed and recurring, associated with product formulation or 
process changes to include antimicrobial agents or processes that limit 
the growth of L. monocytogenes; and the costs to establishments 
required to hold and test products pending confirmation of

[[Page 34223]]

positive food contact-surface tests for Listeria species.
    FSIS estimates that the interim final rule will have combined one-
time and recurring costs to large establishments totaling about $15.9 
million, to small establishments about $55.3 million, and to very small 
establishments about $1.7 million. FSIS assumes a 10-year useful life 
for the changes (e.g., post-lethality treatment validation, 
installation, antimicrobial agent or process alteration, and production 
adjustments) for which establishments incur one-time costs and, using a 
7-percent discount rate, the Agency annualizes these one-time costs 
over the useful life of the changes. Adding these to the annual 
recurring costs, FSIS obtains annualized industry-wide costs of the 
interim final rule to large establishments of about $3.6 million, to 
small establishments about $12.5 million, and to very small 
establishments about $613,000.
    The grand total of industry-wide annualized costs is $16.6 million. 
With the 50 percent downward adjustment discussed above, net benefits 
of $50.8 million at the median and ranging from $5.4 million at the 5th 
percentile to $60.4 million at the 95th percentile are to be derived 
from the interim final rule.
Paperwork Reduction Act
    FSIS has reviewed the paperwork and recordkeeping requirements in 
this interim final rule in accordance with the Paperwork Reduction Act 
and has determined that the paperwork requirements respecting the 
regulations that may cause establishments to evaluate and revise their 
Sanitations SOPS, HACCP plans, and prerequisite programs have already 
been accounted for in the Pathogen Reduction/Hazard Analysis and 
Critical Control Point (HACCP) Systems information collection approved 
by the Office of Management and Budget (OMB). The OMB approval number 
for the Pathogen Reduction/Hazard Analysis and Critical Control Point 
(HACCP) Systems information collection is 0583-0103.
    The requirement that may cause establishments to test for L. 
monocytogenes, to document their testing protocols and their hold-and-
test procedures, and the requirement for establishments that produce 
RTE products to provide FSIS with production volume information by 
product type and L. monocytogenes control alternative are new 
information collections.
    Title: Listeria.
    Type of Collection: New.
    The paperwork and recordkeeping requirements in this interim final 
rule are awaiting approval by the Office of Management and Budget.
    Abstract: FSIS has reviewed the paperwork and recordkeeping 
requirements in this interim final rule in accordance with the 
Paperwork Reduction Act. Under this interim final rule, FSIS is 
requiring an information collection activity. FSIS is requiring that 
establishments that produce ready to eat product annually report the 
estimated production volume by product type and Listeria control 
alternative employed. FSIS is also publishing requirements for RTE 
establishments to conduct, and plans to ask them to report on, food-
contact surface sampling. In addition, FSIS is establishing 
requirements that may cause some RTE establishments to hold and test 
product for L. monocytogenes and other indicator organisms.
    Estimate of Burden: FSIS estimates that the time to collect and 
report the required information on the estimated volume of RTE product 
by product type and Listeria control method is one hour. The Agency 
estimates that it will take establishments 50 minutes to collect the 
information necessary to make the required estimates and 10 minutes to 
report the information by form.
    FSIS estimates that it will take 25 hours to develop a 
microbiological sampling and testing plan to support the efficacy of 
the sanitation controls, including the development of test-and-hold 
procedures. The Agency estimates that it will take two hours to revise 
microbiological sampling and testing plans. And FSIS estimates that it 
will take an average of 30 minutes to conduct a food contact surface 
test and an average of 30 minutes to collect information on product 
samples for test and hold procedures.
    Respondents: Meat and poultry product establishments that produce 
Ready to Eat product.
    Estimated Number of Respondents: 4,975.
    Estimated Number of Responses per Respondent: 10.
    Estimated Total Annual Burden on Respondents: 154,243 hours.
    Copies of this information collection assessment can be obtained 
from John O'Connell, Paperwork Reduction Act Coordinator, Food Safety 
and Inspection Service, USDA, 112 Annex, 300 12th Street, SW., 
Washington DC 20250.
    Comments are invited on: (a) Whether the proposed collection of 
information is necessary for the proper performance of FSIS' functions, 
including whether the information will have practical utility; (b) the 
accuracy of FSIS' estimate of the burden of the proposed collection of 
information, including the validity of the methodology and assumptions 
used; (c) ways to enhance the quality, utility, and clarity of the 
information to be collected; ways to minimize the burden of the 
collection of information on those who are to respond, including 
through the use of appropriate automated, electronic, mechanical, or 
other technological collection techniques, or other forms of 
information technology. Comments may be sent to both John O'Connell, 
Paperwork Reduction Act Coordinator, at the address provided above, and 
the Desk Officer for Agriculture, Office of Information and Regulatory 
Affairs, Office of Management and Budget, Washington, DC 20253.
    All responses to this notice will be summarized and included in the 
request for OMB approval. All comments will also become a matter of 
public record.
Government Paperwork Elimination Act (GPEA)
    FSIS is committed to achieving the goals of the GPEA, which 
requires Government agencies, in general, to provide the public with 
the option of submitting information or transacting business 
electronically to the maximum possible extent. FSIS is making available 
to establishments affected by this interim final rule an electronic 
form by which they may provide the required production volume 
information. The form will be accessible on a special page on the FSIS 
Web site at http://www.fsis.usda.gov; log-on and authentication 
instructions will be provided. Each establishment's submission will be 
treated as confidential. Provision of this electronic form is expected 
to enable the Agency more efficiently to gather, and affected 
establishments to report, the needed information.
    This electronic data collection is intended to meet Goal 4 of the 
e-Government strategy in the President's Management Agenda. The 
electronic filing option is provided to reduce data collection time and 
information processing and handling for the regulated industry and 
FSIS.
    This electronic data collection is intended to be consistent with 
Goal 2 (enhancing collaboration with public and private sector 
organizations to develop and deliver USDA's mission) and Objective 2.4 
of the Department's e-Government Strategic Plan in that it reduces time 
necessary for information collection and processing for both regulated 
establishments and FSIS. A further, related initiative, providing for 
use of electronic signatures and authentication, will be consistent 
with the Department-wide strategies and

[[Page 34224]]

policies to develop and implement e-signature and e-Authentication 
policies.
    1. The interim final rule on L. monocytogenes control in ready-to-
eat meat and poultry products contains a requirement for official 
establishments that prepare post-lethality exposed ready-to-eat meat 
and poultry products to provide FSIS at least annually with data on the 
volume of production of products they prepare in processes that are 
covered by the interim final rule. FSIS is developing a form by which 
to collect the data. The form will be made available to establishments 
in both paper and electronic formats. The electronic form will be 
available for use by affected establishments at all times after the 
rule becomes effective.
    2. FSIS can use its existing information technology resources in 
the electronic data collection. That is, the Agency plans to use its 
existing database applications and server storage to house the data 
collection form and associated databases. FSIS estimates that no more 
than $1,000 in materials and 0.25 FTE annually at the level of a GS-13 
or equivalent staff officer grade in FSIS'S Data Analysis Systems and 
Support Staff, Office of Policy and Program Development, will be 
required to administer the data collection.
    FSIS is developing a centralized system known as the FSIS Automated 
Corporate Technology Suite (FACTS) for which approximately $15 million 
has been earmarked. The system will provide, among other things, 
facilities for accessing Agency electronic forms and for processing the 
data collected through such forms. The new production volume form can 
be integrated with FACTS.
    3. FSIS plans to use e-signature and e-Authentication methods that 
are consistent with Department e-Authentication policy.
    4. Regarding information security, FSIS plans to provide ordinary 
levels of protection for the production volume information obtained. 
Establishment-linked information will be treated as confidential and 
stored in password-protected databases and electronic systems to which 
only authorized personnel have access. Information in paper format will 
be stored under lock and key in file boxes or cabinets to which only 
authorized personnel have access. FSIS does not envision a need for 
sophisticated security or encryption systems to protect this 
information.
    5. For the purpose of this information collection, FSIS does not 
foresee a need for telecommunications systems additional to those 
already operated by the Agency.
    6. The interim final rule does not specifically address 
recordkeeping by establishments but only data reporting. The data 
collected will be stored in a protected database managed by FSIS.

XII. E. O. 12988 Civil Justice Reform

    This interim final rule has been reviewed under Executive Order 
12988, Civil Justice Reform. States and local jursidicitons are 
preempted by the FMIA and the 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 or 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 or 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.
    Administrative proceedings will not be required before parties may 
file suit in court challenging this interim final rule. However, the 
administrative procedures specified in 9 CFR 306.6 and 381.35 must be 
exhausted before any judicial challenge of the application of the 
provisions of this interim final rule, if the challenge involves any 
decision of an FSIS employee relating to inspection services provided 
under the FMIA or PPIA.

XIII. Additional Public Notification

    Public awareness of all segments of policy development is 
important. Consequently, in an effort to better ensure that minorities, 
women, and persons with disabilities are aware of this interim final 
rule, FSIS will announce it and provide copies of this Federal Register 
publication in the FSIS Constituent Update.
    The Constituent Update provides information on 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. These include 
industry, trade, and farm groups, consumer interest groups, allied 
health professionals, scientific professionals, and other individuals 
that have requested to be included. The Constituent Update is available 
on-line through the FSIS Web page located at http://www.fsis.usda.gov/OA/update/update.htm.
    The FSIS Constituent Update is issued via the USDA-
FSISConstituentsListserv to over 400 organizations and individuals on a 
weekly basis. FSIS also issues other communications on the Listserv, 
including news releases, recall notices, and Constituent Alerts on 
important issues. Persons interested in subscribing to the Listserv can 
do so by completing a form at http://www.fsis.usda.gov/OA/update/subscribe.asp.

XIV. Final Regulations

List of Subjects in 9 CFR Part 430

    Food labeling, Meat inspection, Poultry and poultry products 
inspection.

0
Accordingly, title 9, chapter III, of the Code of Federal Regulations 
is amended as follows:
0
1. A new part 430 is added to read as follows:

PART 430--REQUIREMENTS FOR SPECIFIC CLASSES OF PRODUCT

Sec.
430.1 Definitions.
430.4 Control of Listeria monocytogenes in post-lethality exposed 
ready-to-eat products.

    Authority: 7 U.S.C. 450; 7 U.S.C. 1901-1906; 21 U.S.C. 451-470, 
601-695; 7 CFR 2.18, 2.53.


Sec.  430.1  Definitions.

    Antimicrobial agent. A substance in or added to an RTE product that 
has the effect of reducing or eliminating a microorganism, including a 
pathogen such as L. monocytogenes, or that has the effect of 
suppressing or limiting growth of L. monocytogenes in the product 
throughout the shelf life of the product. Examples of antimicrobial 
agents added to RTE products are potassium lactate and sodium 
diacetate.
    Antimicrobial process. An operation, such as freezing, applied to 
an RTE product that has the effect of suppressing or limiting the 
growth of a microorganism, such as L. monocytogenes, in the product 
throughout the shelf life of the product.
    Deli product. A ready-to-eat meat or poultry product that typically 
is sliced, either in an official establishment or after distribution 
from an official establishment, and typically is assembled in a 
sandwich for consumption.
    Hotdog product. A ready-to-eat meat or poultry frank, frankfurter, 
or wiener, such as a product defined in 9 CFR 319.180 and 319.181.
    Lethality treatment. A process, including the application of an

[[Page 34225]]

antimicrobial agent, that eliminates or reduces the number of 
pathogenic microorganisms on or in a product to make the product safe 
for human consumption. Examples of lethality treatments are cooking or 
the application of an antimicrobial agent or process that eliminates or 
reduces pathogenic microorganisms.
    Post-lethality exposed product. Ready-to-eat product that comes 
into direct contact with a food contact surface after the lethality 
treatment in a post-lethality processing environment.
    Post-lethality processing environment. The area of an establishment 
into which product is routed after having been subjected to an initial 
lethality treatment. The product may be exposed to the environment in 
this area as a result of slicing, peeling, re-bagging, cooling semi-
permeable encased product with a brine solution, or other procedures.
    Post-lethality treatment. A lethality treatment that is applied or 
is effective after post-lethality exposure. It is applied to the final 
product or sealed package of product in order to reduce or eliminate 
the level of pathogens resulting from contamination from post-lethality 
exposure.
    Prerequisite program. A procedure or set of procedures that is 
designed to provide basic environmental or operating conditions 
necessary for the production of safe, wholesome food. It is called 
``prerequisite'' because it is considered by scientific experts to be 
prerequisite to a HACCP plan.
    Ready-to-eat (RTE) product. A meat or poultry product that is in a 
form that is edible without additional preparation to achieve food 
safety and may receive additional preparation for palatability or 
aesthetic, epicurean, gastronomic, or culinary purposes. RTE product is 
not required to bear a safe-handling instruction (as required for non-
RTE products by 9 CFR 317.2(l) and 381.125(b)) or other labeling that 
directs that the product must be cooked or otherwise treated for 
safety, and can include frozen meat and poultry products.


Sec.  430.4  Control of Listeria monocytogenes in post-lethality 
exposed ready-to-eat products.

    (a) Listeria monocytogenes can contaminate RTE products that are 
exposed to the environment after they have undergone a lethality 
treatment. L. monocytogenes is a hazard that an establishment producing 
post-lethality exposed RTE products must control through its HACCP plan 
or prevent in the processing environment through a Sanitation SOP or 
other prerequisite program. RTE product is adulterated if it contains 
L. monocytogenes or if it comes into direct contact with a food contact 
surface which is contaminated with L. monocytogenes.
    (b) In order to maintain the sanitary conditions necessary to meet 
this requirement, an establishment producing post-lethality exposed RTE 
product must comply with the requirements included in one of the three 
following alternatives:
    (1) Alternative 1. Use of a post-lethality treatment (which may be 
an antimicrobial agent) that reduces or eliminates microorganisms on 
the product and an antimicrobial agent or process that suppresses or 
limits the growth of L. monocytogenes. If an establishment chooses this 
alternative:
    (i) The post-lethality treatment must be included in the 
establishment's HACCP plan. The antimicrobial agent or process used to 
suppress or limit the growth of the pathogen must be included in either 
the establishment's HACCP plan or its Sanitation SOP or other 
prerequisite program.
    (ii) The establishment must validate the effectiveness of the post-
lethality treatment incorporated in its HACCP plan in accordance with 
Sec.  417.4. The establishment must document, either in its HACCP plan 
or in its Sanitation SOP or other prerequisite program, that the 
antimicrobial agent or process, as used, is effective in suppressing or 
limiting growth of L. monocytogenes.
    (2) Alternative 2. Use of either a post-lethality treatment (which 
may be an antimicrobial agent) that reduces or eliminates 
microorganisms on the product or an antimicrobial agent or process that 
suppresses or limits growth of L. monocytogenes. If an establishment 
chooses this alternative:
    (i) The post-lethality treatment must be included in the 
establishment's HACCP plan. The antimicrobial agent or process used to 
suppress or limit growth of the pathogen must be included in either the 
establishment's HACCP plan or its Sanitation SOP or other prerequisite 
program.
    (ii) The establishment must validate the effectiveness of a post-
lethality treatment incorporated in its HACCP plan in accordance with 
Sec.  417.4. The establishment must document in its HACCP plan or in 
its Sanitation SOP or other prerequisite program that the antimicrobial 
agent or process, as used, is effective in suppressing or limiting 
growth of L. monocytogenes.
    (iii) If an establishment chooses this alternative and chooses to 
use only an antimicrobial agent or process that suppresses or limits 
the growth of L. monocytogenes, its sanitation program must:
    (A) Provide for testing of food contact surfaces in the post-
lethality processing environment to ensure that the surfaces are 
sanitary and free of L. monocytogenes or of an indicator organism;
    (B) Identify the conditions under which the establishment will 
implement hold-and-test procedures following a positive test of a food-
contact surface for L. monocytogenes or an indicator organism;
    (C) State the frequency with which testing will be done;
    (D) Identify the size and location of the sites that will be 
sampled; and
    (E) Include an explanation of why the testing frequency is 
sufficient to ensure that effective control of L. monocytogenes or of 
indicator organisms is maintained.
    (iv) An establishment that chooses this alternative and uses a 
post-lethality treatment of product will likely be subject to more 
frequent verification testing by FSIS than if it had chosen Alternative 
1. An establishment that chooses this alternative and uses an 
antimicrobial agent or process that suppresses or limits the growth of 
L. monocytogenes will likely be subject to more frequent FSIS 
verification testing than if it uses a post-lethality treatment.
    (3) Alternative 3. Use of sanitation measures only.
    (i) If an establishment chooses this alternative, its sanitation 
program must:
    (A) Provide for testing of food contact surfaces in the post-
lethality processing environment to ensure that the surfaces are 
sanitary and free of L. monocytogenes or of an indicator organism;
    (B) Identify the conditions under which the establishment will 
implement hold-and-test procedures following a positive test of a food-
contact surface for L. monocytogenes or an indicator organism;
    (C) State the frequency with which testing will be done;
    (D) Identify the size and location of the sites that will be 
sampled; and
    (E) Include an explanation of why the testing frequency is 
sufficient to ensure that effective control of L. monocytogenes or of 
indicator organisms is maintained.
    (ii) An establishment producing a deli product or a hotdog product, 
in addition to meeting the requirements of paragraph (b)(3)(i) of this 
section, must meet the following requirements:
    (A) The establishment must verify that the corrective actions that 
it takes with respect to sanitation after an initial positive test for 
L. monocytogenes or an

[[Page 34226]]

indicator organism on a food contact surface in the post-lethality 
processing environment are effective by conducting follow-up testing 
that includes a targeted test of the specific site on the food contact 
surface area that is the most likely source of contamination by the 
organism and such additional tests in the surrounding food contact 
surface area as are necessary to ensure the effectiveness of the 
corrective actions.
    (B) During this follow-up testing, if the establishment obtains a 
second positive test for L. monocytogenes or an indicator organism, the 
establishment must hold lots of product that may have become 
contaminated by contact with the food contact surface until the 
establishment corrects the problem indicated by the test result.
    (C) Further, in order to be able to release into commerce the lots 
of product that may have become contaminated with L. monocytogenes, the 
establishment must sample and test the lots for L. monocytogenes or an 
indicator organism using a sampling method and frequency that will 
provide a level of statistical confidence that ensures that each lot is 
not adulterated with L. monocytogenes. The establishment must document 
the results of this testing. Alternatively, the establishment may 
rework the held product using a process that is destructive of L. 
monocytogenes or the indicator organism.
    (iii) An establishment that chooses Alternative 3 is likely to be 
subject to more frequent verification testing by FSIS than an 
establishment that has chosen Alternative 1 or 2. An establishment that 
chooses Alternative 3 and that produces deli meat or hotdog products is 
likely to be subject to more frequent verification testing than one 
that does not produce such products.
    (c) For all three alternatives in paragraph (b):
    (1) Establishments may use verification testing that includes tests 
for L. monocytogenes or an indicator organism, such as Listeria 
species, to verify the effectiveness of their sanitation procedures in 
the post-lethality processing environment.
    (2) Sanitation measures for controlling L. monocytogenes and 
procedures for antimicrobial agents or processes that suppress or limit 
the growth of the pathogen may be incorporated either in the 
establishment's HACCP plan or in its Sanitation SOP or other 
prerequisite program. When these control procedures are incorporated 
into the Sanitation SOP or prerequisite program, and not as a CCP in 
the HACCP plan, the establishment must have documentation that supports 
the decision in its hazard analysis that L. monocytogenes is not a 
hazard that is reasonably likely to occur.
    (3) The establishment must maintain sanitation in the post-
lethality processing environment in accordance with part 416.
    (4) If L. monocytogenes control measures are included in the HACCP 
plan, the establishment must validate and verify the effectiveness of 
measures for controlling L. monocytogenes included in its HACCP plan in 
accordance with Sec.  417.4.
    (5) If L. monocytogenes control measures are included in the 
Sanitation SOP, the effectiveness of the measures must be evaluated in 
accordance with Sec.  416.14.
    (6) If the measures for addressing L. monocytogenes are addressed 
in a prerequisite program other than the Sanitation SOP, the 
establishment must include the program and the results produced by the 
program in the documentation that the establishment is required to 
maintain under 9 CFR 417.5.
    (7) The establishment must make the verification results that 
demonstrate the effectiveness of the measures it employs, whether under 
its HACCP plan or its Sanitation SOP or other prerequisite program, 
available upon request to FSIS inspection personnel.
    (d) An establishment that produces post-lethality exposed RTE 
product shall provide FSIS, at least annually, or more often, as 
determined by the Administrator, with estimates of annual production 
volume and related information for the types of meat and poultry 
products processed under each of the alternatives in paragraph (b) of 
this section.
    (e) An establishment that controls L. monocytogenes by using a 
post-lethality treatment or an antimicrobial agent or process that 
eliminates or reduces, or suppresses or limits the growth of the 
organism may declare this fact on the product label provided that the 
establishment has validated the claim.

    Done in Washington, DC: June 2, 2003.
Garry L. McKee,
Administrator.

    Note: The following appendix will not appear in the Code of 
Federal Regulations.

Appendix A

Final Regulatory Impact Analysis

    FSIS is amending its regulations to require that official 
establishments that produce certain ready-to-eat (RTE) meat and 
poultry products (MPPs) take measures to prevent product 
adulteration by L. monocytogenes (Lm). These amended regulations 
primarily affect establishments that produce RTE MPPs that are 
exposed to the environment following lethality treatment and that 
support the growth of Lm.
    The final rule takes into account the differences in the risk of 
Lm contamination by type of RTE MPP product and by the manner in 
which the pathogen is controlled in the production process. It takes 
into account these differences by identifying four alternative Lm 
control approaches applying to RTE MPPs that are exposed to the 
plant environment after undergoing a process that is lethal to the 
pathogen. Each alternative involves a different level of pathogen 
control and to each there corresponds a preferred level of 
monitoring and verification, based on science and the nature of the 
product.

Need for the Rule

    This action is compelled by recent outbreaks of food borne 
illness related to the consumption of adulterated RTE meat and 
poultry products, coupled with information on the pathogenicity of 
the organism and the findings of the risk assessment and risk 
ranking conducted by FDA and FSIS. Lm contamination is often a 
result of post processing contamination or growth of the organism 
after it leaves the Federal establishment. FSIS concluded before 
beginning this rulemaking that many establishments were not 
effectively implementing HACCP plans and Sanitation SOPs to prevent 
L. monocytogenes from contaminating the RTE product in the post-
lethality processing environment.
    Given the pathogenicity of L. monocytogenes, the opportunity for 
it to contaminate RTE product in the post-lethality environment, and 
the significant consequences that this contamination can have, FSIS 
is amending its regulations. The Agency is adding provisions that 
require establishments that produce post-lethality exposed RTE 
product to include in their HACCP plans or in their Sanitation SOPs 
or other prerequisite programs measures that prevent product 
adulteration by L. monocytogenes.
    Market Failure. This final rule addresses a market failure. 
Market failures occur when resources are misallocated or allocated 
inefficiently. Markets fail, in the current case, because processors 
may not always be provided with sufficient incentives to allocate 
the additional resources and efforts needed to provide effective 
prevention methods for pathogen contamination in their products. 
These incentives are lacking because consumers cannot identify (and 
reward) those firms that produce RTE MPPs and are implementing the 
desired food safety safeguards. Therefore, consumers are unable to 
distinguish these products from those produced by lower cost firms 
that are applying less effective pathogen prevention methods. The 
lack of information on the safety of the products produced by the 
establishments in this latter group is a major concern of this rule. 
The recent FSIS risk assessment clearly indicates that products from 
establishments that are not taking these precautions can lead to 
illness or death.
    The provisions of this final rule are designed to provide 
establishments a choice of selected, proven technologies to minimize 
the presence of Listeria in their processing

[[Page 34227]]

environment. The use of these technologies and documentation of 
records on the environment of these establishments, brought about by 
this final rule, will provide the kind of information, and needed 
food safety assurance, that is lacking for consumers.

Rationale for the Approach Taken

    The economic rationale for the requirements of the final rule is 
that it recognizes that a combination of interventions have been 
shown to be more effective that a single intervention and builds 
this into the framework of regulation. Second, the requirements 
recognize that the level of risk varies by product and how it is 
produced. Third, the requirements provide incentives for the 
establishment to adopt sanitation and testing practices that are 
most suitable for its products and processes. And lastly, these 
incentives for establishments have been shown to be preferable over 
mandatory requirements.
    The FDA/FSIS risk ranking \1\ found that RTE MPPs posed a 
moderate to high human health risk, particularly among vulnerable 
populations. These products include deli meats, hotdogs, meat 
spreads, p[acirc]t[eacute], and deli salads that include RTE meat or 
poultry products as components. The risk ranking indicates that 
among the RTE MPPs, deli meats pose an especially high risk.
---------------------------------------------------------------------------

    \1\ FDA, FSIS, CDC. ``Draft Assessment of the Relative Risk to 
public Health from Foodborne Listeria monocytogenes Among Selected 
Categories of Ready-to-Eat Foods''. The document is available at 
www.foodsafety.gov.
---------------------------------------------------------------------------

    The FSIS Risk Assessment for L. monocytogenes in Ready-to-Eat 
Deli Meats \2\ (FSIS Lm risk assessment) estimated the reduction in 
fatalities among vulnerable populations from consuming contaminated 
deli meats that might be achieved through in-plant sanitation with 
verification testing regimes of increasing intensity. These results 
were compared with estimates for similar fatality reductions that 
might be achieved by applying post-lethality treatments or growth 
inhibiting additives or processes. Based on the finding of the FSIS 
Lm risk assessment, the Agency concluded that a combination of 
interventions, including sanitation coupled with verification 
testing, and the use of growth inhibitors, appears to be more 
effective in controlling Lm than a single intervention in these 
operations.
---------------------------------------------------------------------------

    \2\ USDA, FSIS. ``Draft Risk Assessment for Listeria 
Monocytogenes in Ready-to-eat Deli Meat Products''. FSIS. March 
2003. The risk assessment is available at www.fsis.usda.gov.
---------------------------------------------------------------------------

    FSIS considered the findings of the FDA/FSIS risk ranking and 
the Agency's Lm risk assessment and the public comments that had 
been submitted on the Agency's proposed rule regarding control of Lm 
in RTE products. Many of the comments expressed opposition to 
proposed mandatory testing frequencies--either the frequencies 
themselves or the fact that they would be mandated. Instead of 
mandatory testing requirements, the Agency is requiring that 
establishments incorporate appropriate verification methods into 
their HACCP plan, Sanitation SOP, or prerequisite program. This 
approach provides establishments with incentives to test for Lm and 
the flexibility to implement control measures that are appropriate 
for the types of products produced and processing methods at the 
establishment.
    The final rule sets out four alternative Lm control approaches. 
For the purposes of this analysis, FSIS has grouped the affected 
establishments according to their use of these Lm control 
approaches.

Changes Between the Proposed and the Final Rule

    FSIS considered four regulatory options for this final rule that 
had been generated from comments on the proposed rule. The options 
were: (1) No action; (2) a sanitation performance standard for 
reduction of Lm in RTE MPPs; (3) mandatory testing frequencies for 
Listeria species on food contact surfaces different from the 
frequencies proposed; and (4) a warning label to inform consumers in 
vulnerable groups of the potential for Lm contamination.
    FSIS determined that: (1) Comments supported a final rule; (2) 
scientific support for a sanitation performance standard was 
lacking; (3) mandatory testing frequencies were objectionable for 
reasons given in the comments; (4) a warning label would be 
inappropriate because, under the law, all RTE meat and poultry 
products must be not adulterated and thus safe for all consumers.
    FSIS adopted a modification of the third option. It will require 
establishments to describe their testing programs in their HACCP 
plans or in their Sanitation SOPs or other prerequisite programs, as 
appropriate for products and processing technologies. It will also 
require establishments to set the frequency of their verification 
tests for Lm on food contact surfaces, but will not mandate a 
specific frequency. The Lm control alternative influences the 
frequency of verification testing at an establishment. Verification 
testing is expected to be most frequent for establishments that 
produce post-lethality exposed deli meats and hotdogs and rely 
exclusively on sanitation and verification testing to control Lm.
    The final rule identifies four Lm control alternatives that are 
typical of industry practices. The purpose of these control 
alternatives is to link the usage of HACCP or sanitation procedures 
with the risk of Lm contamination based on the FDA/FSIS risk ranking 
and the FSIS Lm risk assessment. The control approaches are: (1) A 
HACCP-based post-lethality treatment plus Lm growth limiting 
measures; (2) a HACCP-based post-lethality treatment or Lm growth 
limiting measures; (3) solely sanitation and verification control 
measures in its post-lethality treatment and no Lm growth inhibiting 
measures--and producing a class of post-lethality exposed product 
that is not a deli product or a hotdog product; and (4) solely 
sanitation and verification control measures in its post-lethality 
treatment and no Lm growth inhibiting measures--and producing a 
class of post-lethality exposed product that is a deli product or a 
hotdog product. For the purposes of this analysis, FSIS has grouped 
all establishments producing RTE MPPs that are exposed post-
lethality according to their current and expected use of these Lm 
control approaches and this analysis will refer to these 
establishment groups as establishment group (EG) 1 through 4.
    The proposed rule would have required RTE MPP establishments to 
control Lm either in their HACCP plans or their Sanitation SOPs. The 
final rule requires establishments to include post-lethality 
treatments in their HACCP plans and allows them to have other types 
of Lm contamination controls in their HACCP plans or in their 
Sanitation SOPs or other prerequisite programs. This modification of 
the proposal is based on the finding that the establishment's use of 
a post-lethality treatment represents a determination by the 
establishment that Lm is a hazard reasonably likely to occur.
    The prerequisite program provisions in the final rule respond to 
comments that the Agency should provide establishments with greater 
flexibility in implementing Lm contamination controls. In 
particular, RTE MPP establishments usually do not control post-
processing contamination through HACCP alone, but through a variety 
of prerequisite programs.
    In response to public comments, the final rule also does not 
mandate food contact surface (FCS) testing frequencies. Instead, the 
final rule sets out specific requirements, for Alternatives 2 and 3 
for sanitation procedures that are included in HACCP plans, or in 
Sanitation SOPs or other prerequisite programs. Establishments are 
allowed to choose their own testing methods and frequencies for 
verifying the effectiveness of their procedures.
    The sanitation procedure requirements for Alternative 3 
establishments that process hotdog and deli meat products and 
control for Lm using sanitation procedures only, include hold-and-
test provisions. These procedures are invoked when follow-up testing 
to verify corrective actions in response to Listeria-positive FCS 
test results. A second positive FCS test for L. monocytogenes or an 
indicator organism entails withholding from commerce product that 
was in contact with the contaminated surface. Shipments can resume 
when subsequent tests in the same area of the plant are negative. 
The product can be tested under a sampling plan that provides 
sufficient confidence to enable the product to be released into 
commerce. The requirements for Alternative 3 establishments that 
process deli meats and hotdogs represent a modification of the hold-
and-test procedures that the proposal would have required (proposed 
Sec.  430.4(b)) but imposes this requirement only on establishments 
producing hotdog and deli-meat type products. This particular change 
from the proposal is responsive to comments opposing mandatory 
testing frequencies and the proposed hold-and-test requirements, 
which would have applied to all RTE MPPs. The requirements for 
Alternative 3 establishments that process deli meats and hotdogs are 
also responsive to the FDA/FSIS risk ranking which identified hot 
dog and deli-meat products as posing a moderate to high risk for 
listeriosis on a per annum basis (as opposed to a per serving 
basis), and the FSIS Lm risk assessment which evaluated the risk-
reduction effectiveness of various

[[Page 34228]]

combinations of in-plant interventions, including FCS testing, with 
and without test and hold actions.
    The final rule also differs from the proposal by requiring RTE 
MPP establishments to furnish FSIS with at-least-annual estimates of 
production volume by type of RTE MPP and by alternative Lm control 
program used. This change responds to comments on the proposed rule 
indicating opposition to the use of establishment size criteria in 
determining verification testing intensity and to information 
provided in the public comments indicating that there may not be a 
connection between establishment size and volume of production. 
These comments noted that production volume is dependent on factors 
other than establishment size, such as technology.
    Finally, the rule allows labels on RTE MPPs to show that the 
products were processed in a manner to eliminate, reduce, or limit 
the growth of Lm, provided that the claim is validated. This 
provision is not a regulatory requirement in that it does not 
mandate such labeling, but is intended to encourage the industry to 
implement effective Lm controls and to provide useful information to 
consumers, especially vulnerable subpopulations.

Coverage

    FSIS found that that the final rule will affect 2,930 federally 
inspected RTE MPP establishments and about 2,046 State-inspected 
establishments. About 144 of these establishments are considered 
large, 1,276 small and 3,556 very small, using the size criteria 
adopted by FSIS in implementing the HACCP regulations. FSIS was able 
to determine that the baseline numbers of federally and State-
inspected establishments in the respective Lm control groups 1 
through 4 are, respectively: 49; 2,297; 1,864; and 766. These 
numbers are expected to change as a result of this rule.
    FSIS was further able to determine that, because of the 
intensity of verification testing that sanitation-and-testing 
establishments would have to implement to ensure that product 
contaminated with Lm is not shipped, a certain percentage of 
establishments in this group are likely to decide to put their Lm 
controls in their HACCP plans or to adopt Lm growth suppressing or 
limiting methods. They would decide, therefore, to ``move or 
migrate'' into the grouping of establishments that take either the 
first or the second Lm control approach. The number of 
establishments in establishment groups 1 through 4 is expected to be 
95, 2,363, 1,864, and 654, respectively, after the final rule goes 
into effect. The expected movement among establishment groups is 
discussed in detail in a later section.
    The numbers of establishments in each of these Lm control 
groupings will determine the allocation of FSIS inspection resources 
for Lm control verification. FSIS will verify that establishments 
that produce RTE products are carrying out Lm control procedures in 
their post-lethality processing areas as described in their HACCP 
plans or their Sanitation SOPs or other prerequisite programs, and 
that they are complying with the requirements of this final rule. In 
addition to verifying establishment Lm controls, the Agency will 
verify that any label claims regarding Lm control have been 
validated. The frequency of FSIS verification testing of 
establishment Lm controls is expected to be higher for each 
successive Lm control alternative. In other words, the frequency 
will be lowest for establishments that use control Alternative 1 and 
highest for establishments that use control alternative 3 and that 
produce deli meats and hotdogs.

Establishment Groups

    Grouping by Control Method. For the purposes of this analysis, 
four establishment groups can be identified in the final rule. The 
four groups are composed respectively of the establishments choosing 
L. monocytogenes control Alternatives 1 through 3, and the deli 
meat- and hotdog-producing establishments choosing Alternative 3 (9 
CFR 430.4(b)(1), (b)(2), (b)(3)(i) and (b)(3)(ii)):
    Establishment Group One (9 CFR 430.4(b)(1)): Establishments 
apply a post-lethality (PL) treatment to their products or process 
and use a Lm growth inhibiting agent or process. Products produced 
by establishments in EG 1 are expected to present the least risk of 
possible Lm contamination of products because they use a combination 
of intervention measures. EG 1's HACCP, Sanitation SOP or other 
prerequisite program controls and FSIS's ``normal'' verification 
procedures are expected to provide information that is adequate to 
assure the establishment and FSIS inspection personnel that an 
adulterated product is not being produced.
    Establishment Group Two (9 CFR 430.4(b)(2)): Establishments 
apply either a post-lethality treatment to their products or use a 
Lm growth inhibiting agent or process. Because establishments in EG 
2 apply a PL treatment to their products or use a growth inhibiting 
agent or process, but not both, this group's products present a 
somewhat higher level of risk. They still would be considered 
``safe'' with a high degree of certainty, but this final rule will 
provide additional assurance that the products are not adulterated 
by requiring EG 2 establishments to test food contact surfaces 
(FCSs) and make the test results available to FSIS.
    Establishment Group Three (9 CFR 430.4(b)(3)(i)): Establishments 
use neither a PL treatment nor a growth inhibiting agent or process, 
but has Sanitation standard operating procedures (Sanitation SOP) or 
other prerequisite programs and produce a class of post-lethality 
exposed product that is not a deli product or a hotdog product.
    Establishment Group Four (9 CFR 430.4(b)(3)(ii)): Establishments 
use neither PL treatments nor Lm growth inhibiting agents or 
processes in their RTE MPP production, but have Sanitation SOP or 
other prerequisite programs and produce a class of post-lethality 
exposed product that is a deli product or a hotdog product. 
Establishments in EG 4 produce RTE MPPs that have been identified in 
recent risk assessments as posing significant risk of Lm 
contamination in their post-processing environment and significantly 
contribute to illnesses and deaths. The Lm control measures for 
establishments in EG 4 are similar to those of EG 3, but FSIS feels 
that specific holding action requirements are justified to ensure 
that no adulterated product enters commerce when a second 
consecutive positive FCS test in the post-lethality processing 
environment of a EG 4 is found. A guide to the final rule 
requirements by establishment group is given in Table 1.
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[[Page 34230]]

Analysis of Costs

    Number of Establishments. The preliminary regulatory impact 
analysis relied on the 1997 Census of Manufacturers for an initial 
count of RTE MPP establishment numbers. 1,630 establishments were 
identified as producing a RTE MPP. The estimated number of 
establishments affected by the proposed rule was expected to be 
fewer than the actual number total for many reasons, but chiefly 
because the Census classifies businesses according to their 
principal activity. In some cases, the production of RTE MPP might 
be a secondary activity. This undercounting was a major deficiency 
in the preliminary regulatory impact analysis (PRIA). FSIS has 
corrected this problem and is estimating the impacts of the final 
rule considering both federally and State-inspected establishments 
producing RTE MPPs.
    Basing the analysis on a more realistic estimate of the number 
and types of establishments affected by the rule provides a better 
estimate of industry impacts. However, using this approach, the 
product-specific information, such as the value of production, that 
was available through Census data, cannot be used. Also, certain 
assumptions must be made in manipulating the data for both federally 
and State-inspected establishments to avoid double counting and to 
estimate HACCP process categories for RTE MPPs at State-inspected 
establishments.
    FSIS used the 2001 Performance-Based Inspection System (PBIS) 
databases to identify Federal-inspected establishments that have at 
least one HACCP process category code (actually, the pertinent 
procedure code from FSIS's inspection system procedure guide) 
associated with a RTE MPP. The 2001 PBIS database showed that there 
were 2,930 federally inspected establishments with 3,556 HACCP 
process category codes associated with RTE MPPs. Establishments were 
grouped into HACCP establishment size categories by cross tabulating 
this data with the 2001 Enhanced Facilities Database (EFD). (HACCP 
establishment size categories have been defined since the 
publication of the PR/HACCP rule (61 FR 38806; July 25, 1996) as 
large: more than 500 employees; small: between 499 and 10 employees; 
and very small: Fewer than 10 employees or less than $2.5 million in 
annual sales.) To obtain the number of unique establishments in each 
HACCP process category code, the number of HACCP plans for each 
HACCP process code was divided by the average number of HACCP plans 
per establishment in each size category (bottom of Table 2).
    The EFD identified 2,046 State-inspected RTE MPP establishments 
comprised of 1,992 very small establishments and 54 small 
establishments. To obtain an estimate of the product types produced 
at State-inspected plants, the total number of State-inspected 
establishments was distributed across the four HACCP process 
category codes in the same proportion that was found in federally 
inspected establishments (Table 3).
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[[Page 34232]]


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[[Page 34233]]

    The total number of establishments producing RTE MPP products is 
estimated to be 4,976: 59 percent federally inspected and 41 percent 
State-inspected. Of the total, 4.6 percent are associated with the 
O3E HACCP code; 20.2 percent with the O3F code; 71.1 percent with 
the O3G code; and, 4.1 percent with the O3I code (Table 4). Further 
analysis of HACCP size categories shows that 71.5 percent of all RTE 
MPP establishments are very small; 25.6 percent are small; and, 2.9 
percent are large.
    Product groups. The PRIA classified RTE MPP establishments by 
the expected range of potential cost impact on those establishments: 
Those likely to incur the greatest costs, moderate costs, minor 
costs, and no likely costs (Table 3 in Federal Register, Vol. 66, 
No. 39). This grouping was based on the likely impact from both the 
proposed testing programs as well as the proposed changes in 
lethality and stabilization performance standards. The final rule 
concerns only that section of the proposed rule dealing strictly 
with FSIS's desire to increase safeguards with respect to possible 
Lm contamination. Because of this and also because products and 
production processes vary across the same product classification, it 
is not feasible to disaggregate in the fashion of the PRIA. However, 
it appears that the largest impact will be on establishments 
producing cooked RTE MPP products--those products associated with 
HACCP process code O3G. There is little likelihood that there will 
be any cost impact on RTE MPP establishments producing products in 
the O3E, O3F and O3I HACCP process codes, except for costs 
attributable to a possible increase in FCS testing mandated by the 
rule. These costs are expected to be minor because many of the 
establishments in the HACCP process category codes already apply an 
agent or process that inhibits Lm growth so many of these 
establishments ``qualify'' to be classified in EG 2.
    Establishments associated with the O3G HACCP process category 
code produce cooked RTE MPPs which may or may not be able to apply 
post-lethality treatment to products, apply antimicrobial agents, or 
include procedures in either Sanitation SOPs or prerequisite 
programs. In some cases, FCS testing and disclosure of those results 
to FSIS may result in minor cost increases similar to those for 03E, 
03F, and 03I HACCP process category codes. For other products in the 
03G HACCP process code, they could be produced under any of the four 
alternative post-lethality Lm control regimes identified in this 
final rule. In those cases, the costs could be significantly higher. 
Accordingly, the cost impact discussion is presented by each 
establishment group, type of products produced, and their associated 
establishment numbers and size distribution.
    Impacts according to establishment group. The Agency anticipates 
that the measures taken by establishments will differ by 
establishment group. The following describes the major types of 
responses expected to be taken in response to the final rule for 
those establishments switching establishment groups and/or 
validating current Lm controls.

EG 1 EG 2 Impacts

    (1) Incorporation of post-lethality treatments and/or their 
validation for FSIS: Many establishments are currently using post-
lethality measures to address possible Lm contamination. These 
actions may have been taken in response to client requirements, the 
recent FSIS Lm intensified verification program, or in anticipation 
of further FSIS action. The costs of these actions taken by 
establishments are not attributed to the final rule. However, 
measures taken to satisfy this requirement or to validate these 
measures to FSIS are attributed to the final rule. These measures 
include: Post-lethality heating (may not be feasible for many 
products, especially those with a high fat content); high-pressure 
systems, which may be limited to a few specialty items and usually 
have a low throughput; and irradiation, which is not permitted to be 
applied to RTE MPPs at present. FSIS expects establishments using 
post-lethality treatments to verify that their treatments are 
effective and also to monitor FCSs to assure that the treatment is 
effective. This level of verification FCS testing for establishments 
in EG 1 is expected to be about twice yearly.
    (2) Use of agent in product formulation or change in processes 
to inhibit Lm growth in product: FSIS has recently permitted the use 
of certain food additives that inhibit Lm growth (65 FR 17128, March 
31, 2000). These additives include lactate and diacetates that have 
been applied increasingly to cooked and cured RTE MPPs such as 
hotdogs. The cost to establishments of taking measures involving the 
use of these additives is not attributable to the final rule. The 
Agency estimates that up to 70 percent of all hotdog manufacturers 
have recently changed their product formulations to incorporate one 
of the recently permitted food additives. Changes in a process that 
would help inhibit the Lm growth in the product include: lowering 
the pH or water activity levels and refrigerating or freezing the 
product following processing. Growth inhibiting processes uses 
antimicrobial agents to control growth in post-lethality exposed 
products such as many hotdogs and certain other kinds of sausages. 
Verification FCS testing for establishments in EG 2 would be 
expected at least once per quarter. This level of testing would be 
expected whether the establishment administered a PL treatment or 
applied a Lm growth inhibiting agent or included a process in either 
a Sanitation SOP or prerequisite program.

EG 3 and EG 4 Impacts

    (1) FCS testing frequencies: For the purpose of this analysis, 
the minimum level of FCS testing expected for establishments in EG 3 
is at least once per month: once a month for high, once a month for 
small, and once a month for very small establishments. Also, the 
minimal level of FCS testing for EG 4 is: at least weekly for high-
volume establishments, semi-monthly for small volume establishments, 
and monthly for very small (or low volume) establishments (4-2-1). 
These testing frequencies are illustrative in that the actual 
testing frequencies incorporated into final compliance guidelines 
may differ.
    A potential unintended impact of the rule for establishments in 
EG 4 might be the incentive to reduce their current level of FCS 
testing if results are to be shared with FSIS. An establishment in 
this group may conduct fewer tests if results could lead to costly 
hold-and-test actions. This potential unintended impact was not be 
quantified in this analysis.

EG 4 Impacts

    (1) Hold and Test: EG 4 establishments may be unable to (1) 
apply a post-lethality treatment or (2) apply an agent or include a 
process in either the Sanitation SOP or prerequisite program for a 
variety of reasons. Product from these establishments can be held on 
the basis of FCS testing results shared with the Agency. Multiple 
episodes of holding product may be incurred in the case of two 
consecutive positive FCS test results.

Baseline

    Establishment Types. The compliance cost impacts of the rule 
differ significantly among establishment groups and by HACCP size 
category. The current distribution of establishments by group and 
size serves as the baseline for determining the distribution of 
compliance cost and also the starting point for the expected 
establishment shifts among establishment groups discussed below.
    Table 4 indicates that 1,440 establishments produced RTE MPPs in 
the O3E, O3F, and O3I HACCP process category codes. For purposes of 
this analysis, these establishments are distributed 90 percent in EG 
2 and 10 percent in EG 3. The high proportion in EG 2 is a result of 
the use of growth inhibitors in most of these products which include 
cured and salted products. These products have not been associated 
with listeriosis outbreaks.
    The remaining 3,536 establishments in O3G produce cooked RTE 
MPPs that may be produced by any of the four Lm control methods. 
These establishments were partitioned into the four establishment 
groups as follows:
    (1) From a December 2002 FSIS hotdog and deli meat survey, we 
know that there are 1,712 operations producing hotdogs and/or deli 
meats. Given that 38 percent of these operations produce both 
hotdogs and deli meats, the actual number of unique establishments 
involved is 1,061 ((1 - .38) x 1,712).
    (2) The number of establishments producing cooked products other 
than hotdogs and/or deli meats was estimated by subtracting the 
number of single establishments producing hotdogs and/or deli meats 
from the total number of establishments producing cooked products 
(3,536 - 1,061 = 2,475).
    (3) FSIS inspection program personnel were contacted to estimate 
the proportion of establishments producing hotdog/deli meat and 
other cooked products in each of the establishment groups. These 
estimates, provided in Tables 5 and 6, were used to partition the 
establishments producing hotdog and deli meats and the other cooked 
RTE MPPs by establishment group (Table 7).
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[[Page 34235]]

    Health Consequences. The baseline for comparing human health 
benefits associated with the rule is established by the ``Draft FSIS 
Risk Assessment for Listeria Monocytogenes in Ready-to-eat Deli Meat 
Products''\3\ (Lm Risk Assessment). The Lm Risk Assessment concludes 
that 320 deaths are attributable to RTE deli meats. It is not 
possible at this time to identify the number or deaths attributable 
to RTE MPPs, which in addition to deli meats includes hotdogs, 
fermented sausages, and related products.
---------------------------------------------------------------------------

    \3\ USDA, FSIS. ``Draft Risk Assessment for Listeria 
Monocytogenes in Ready-to-eat Deli Meat Products''. FSIS. March 
2003. The risk assessment is available at www.fsis.usda.gov.
---------------------------------------------------------------------------

    The FDA/FSIS risk ranking model \4\ estimates that there are 
about 340 billion servings of all RTE products consumed per year. 
RTE MPPs are contained within the following classes: reheated 
franks, non-reheated franks, deli meats, fermented sausages, 
p[acirc]t[eacute], and deli-salads. These classes comprise about 43 
billions servings. The deli meat class is responsible for 49 percent 
of the 43 billion servings of RTE MPP. The two hotdog classes are 
together responsible for 15 percent of the servings of RTE MPP. 
Based on these estimates, there could be as many 375 annual 
fatalities associated with RTE MPPs.
---------------------------------------------------------------------------

    \4\ FDA, FSIS, CDC. ``Draft Assessment of the Relative Risk to 
Public Health from Foodborne Listeria Monocytogenes Among Selected 
Categories of Ready-to-Eat Foods''. The document is available at 
www.foodsafety.gov.
---------------------------------------------------------------------------

    The Lm Risk Assessment, because of its focus on deli meats, is 
only able to estimate the human health benefits associated with the 
rule as it affects this category of products. For purposes of 
establishing a baseline for potential human health benefits, deli 
meats are divided into two categories: Products sliced and packaged 
at the establishment; and retail sliced product. Pre-packed products 
are post-lethality exposed and the focus of the regulation. Retail-
sliced products are not post-lethality exposed until prepared for 
use or sale at a retail location. The human health exposure to each 
type of product is a function of its share of total RTE deli meats 
consumed and the level of contamination in each type of product. 
Actions by FSIS can reduce the exposure to some, but not all RTE 
deli meat.
    The Economic Research Service estimates that pre-packaged 
product accounts for 46 percent ($11.6 billion) of total sales of 
RTE deli meats ($25.2 billion) and retail sliced product the 
remaining 54 percent ($13.6 billion).\5\ Volume of product in the 
categories would provide a more suitable basis for establishing a 
baseline level.
---------------------------------------------------------------------------

    \5\ The estimate is based on information from the A.C. Nielson 
Co. 2001 Consumer Expenditures Study as reported in Progressive 
Grocer, September, 2002. The data sources are: supermarket checkout 
scanner data from a representative sample of 10,000 U.S. 
supermarkets, a representative consumer panel consisting of 55,000 
households, and Progressive Grocer estimates.
---------------------------------------------------------------------------

    There is considerable uncertainty about the level of 
contamination in each type of product when purchased. A recent study 
by Gombas, Chen, Clavero, and Scott \6\ finds that there is a 0.4 
percent prevalence rate for Lm in pre-packaged product and a 2.7 
percent prevalence rate for Lm in retail sliced product at the 
retail level. If 0.4 percent of pre-packaged product was found to be 
contaminated at the processing plant, it follows that 0.4 percent of 
the 2.7 percent prevalence rate at retail might be due to 
contamination at the processing site. That means that the prevalence 
of product solely contaminated during retail slicing is 2.3 percent 
(the observed 2.7 percent minus the 0.4 percent that was 
contaminated at the processor site). Using this information and the 
relative market share weights for pre-packaged and retail sliced 
deli meats from ERS provides a weighted average exposure rate for 
deli meats: .004(0.46) + 0.004(0.54) + .027 (.54) = .0164 or, .004 + 
.01242 = .01642
    The pre-packaged product share of the weighted average exposure 
rate is 24.4 percent (.004/.01642 = 0.2436) and the retail sliced 
product share is the remaining 75.6 percent. Therefore, the human 
health baseline risk which the FSIS can affect at federally 
inspected establishments is a potential maximum 78 deaths (24.4 x 
320).
---------------------------------------------------------------------------

    \6\ ``Survey of Listeria monocytogenes in Ready-to-Eat Foods'', 
Journal of Food Protection 66 (H): 559-569.
---------------------------------------------------------------------------

    The Agency has several concerns about this approach to establish 
a baseline level of human health risk. The prevalence levels 
estimated by Gombas, et al. and based on National Food Processing 
Association (NFPA) Survey data, taken at retail establishments, are 
significantly lower than those found by FSIS and reported in the Lm 
Risk Assessment Model. Levine, et al.\7\ reported 1999 prevalence 
levels of Lm at 2.71 percent for cooked, roast, and corned beef and 
4.58 percent in sliced ham and other pork luncheon meats. All 
samples were collected at production facilities, not at retail. The 
prevalence levels from the NFPA and FSIS studies are not entirely 
comparable, but they do seem to be inconsistent, even after taking 
into account basic limitations in the data used in both studies. The 
NFPA survey data describe the difference in prevalence between 
product contaminated at processing and product contaminated at 
retail. It is important to recognize that some of the product found 
contaminated at retail was contaminated at the processor but was 
only detected at retail. It is difficult to reconcile FSIS product 
sampling which finds 2.7-4.6 percent of RTE meats positive for Lm, 
with the finding based on the NFPA survey data that only 0.4 percent 
of packaged RTE meats are positive at retail outlets. Some net 
growth, not dying off, of Lm within contaminated packages between 
processor and retail is expected. The Agency concludes that there is 
much uncertainty about the true proportion of products contaminated 
at the processor and at the retail facility and among products 
affected by the rule and not affected by the rule.
---------------------------------------------------------------------------

    \7\ Levine P, Rose B, Green S, Ransom G, and Hill W (2001). 
Pathogen testing of ready-to-eat meat and poultry products collected 
at federally-inspected establishments in the United States, 1990 to 
1999. Journal of Food Protection 64(8):188-1193.
---------------------------------------------------------------------------

    All things considered, the Agency concludes that it is 
appropriate to make at least a 50-percent reduction in the potential 
deaths and illnesses averted due to Lm control measures taken by RTE 
MPP establishments as a result of this rule (versus the 24.4 percent 
based on the estimate presented). This percentage takes into account 
the study by Gombas, et al., and discussions with FSIS industry 
experts, risk assessors, and microbiologists. Consequently, the 
maximum potential reduction in fatalities achieved through Agency 
measures for RTE deli meat products is 180 (320 x .5). This level 
would be somewhat higher if hotdogs, fermented sausage, and related 
products were included in the Lm Risk Assessment.

Expected Movement Among Establishment Groups

    There are six major industry cost impacts that are expected with 
the final rule. Most of these impacts arise because some 
establishments are expected to shift into establishment groups that 
entail different technologies than they currently employ. These 
shifts are attributed to compliance with requirements of the rule. 
Costs are estimated on the basis of such shifts among the 
establishment groups. The movements among establishment groups are 
based on the experience and judgment of FSIS personnel which were 
pooled together to produce certain guidelines to estimate the 
expected movement of establishments across establishment groups, 
depending on their establishment size. For large establishments, it 
is expected that, based on this collective judgment, 20 percent of 
the establishments in EG 2 (that were already applying a PL 
treatment and referred to as EG 2A) would move into EG 1 (Table 8). 
These seven establishments already had the necessary equipment for 
these treatments, but simply had not validated their use. Therefore, 
only very little additional cost was involved for these 
establishments to move into EG 1 (along with the adoption of 
applying a Lm inhibiting agent or process). A 10-percent shift in 
establishments in EG 2B and EG 4 is expected because these 
establishments have not incurred the high initial costs of the post 
lethality equipment, resulting in a shift of seven establishments 
from EG 2B and two from EG 4. No establishment shifts in EG 3 are 
anticipated. In total, the application of these guidelines produced 
an increase of 16 establishments in EG 1 (Table 9).
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[[Page 34237]]

For small establishments, the combination of the high cost of 
technologies involved in EG 1 and/or EG 2 plus their limited volume 
of production is expected to lower their propensity for 
establishments to shift to another establishment group. Also, 
characteristics of their products and their production are expected 
to limit establishment shifts. Because of these constraints, it is 
expected that only 31 establishments (or 10 percent of the small 
establishments in EG 4) are likely to migrate to EG 1 as a result of 
the final rule (Table 10). Recall that all such movement involves 
the purchase and use of new technology. For most of these 
establishments, the option of adding a Lm inhibiting agent or 
process is probably a more attractive, least-cost option. As a 
result, 25 percent of the existing number of small establishments in 
EG 4 (or 77 establishments) is expected to shift into EG 2. No small 
establishments in EG 3 are expected to shift establishment groups. 
In total, 108 small establishments are expected to shift from EG 4 
into either EG 1 or EG 2 (Table 11).
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[[Page 34238]]

[GRAPHIC] [TIFF OMITTED] TR06JN03.020

BILLING CODE 3410-DM-C
    For very small establishments, the combination of high costs 
associated with technologies necessary to ``qualify'' for EG 1 or EG 
3 and the nature of their product or production is expected to make 
it highly unlikely that any establishment will move into a different 
establishment group as a result of this final rule. The total 
expected establishment movements expected as a result of this final 
rule are given in the table below (Table 12).
[GRAPHIC] [TIFF OMITTED] TR06JN03.021

    Cost to validate a post-lethality treatment for establishments 
in EG 1 and EG 2. It is expected that 43 HACCP plans of 35 
establishments (of the original 49 establishments in EG 1) will need 
to be validated (Table 13). This represents only

[[Page 34239]]

about 15 percent of all the HACCP plan validations that will occur 
as a result of the final rule. This number of HACCP plan validations 
is based on a 50-percent validation rate currently being attained by 
large establishments, 30-percent rate by small, and a 10-percent 
rate by very small establishments. These rates are based on 
information that FSIS obtained from industry sources and in its 
public meetings related to the proposed rule and Lm risk assessment. 
Given the high relative numbers of small and very small 
establishments whose HACCP plans require validation, the total 
number of establishments affected is 35.
    The major impact of the need for HACCP plan validation occurs in 
establishments already in EG 2 that have an unvalidated PL treatment 
(60 percent of all expected validation expenses incurred by 
establishments that already apply a PL treatment). To calculate this 
impact, establishments in EG 2 are grouped by the same validation 
rate used for EG 1 establishments above. To the extent that PL 
treatments are validated by the manufacturer, validation costs would 
be lower.
    Some validation costs are incurred by establishments in EG 2 
that are expected to move into EG 1 (20 percent of the large 
establishments that currently have a PL treatment and 10 percent of 
those that do not have a PL treatment in EG 2) and some 
establishments in EG 4 that are expected to move into EG 1 (10 
percent of the large and small establishments currently in EG 4).

[[Page 34240]]

[GRAPHIC] [TIFF OMITTED] TR06JN03.022

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[[Page 34241]]

    Cost to install a post-lethality (PL) treatment. Establishments 
in EG 1 and about half in EG 2 already have a PL treatment by virtue 
of being classified in that establishment group. Establishments in 
EG 4 and those in EG 2 that use an agent or have a process to 
control Lm do not necessarily have a PL treatment. Seven large 
establishments are expected to move from EG 2 to EG 1 and 1 large 
establishment moving from EG 4 will need to install PL treatments. 
31 small establishments are expected to move from EG 4 to EG 1 and 
will make similar adjustments.
    The Agency received comments to the proposed rule indicated that 
such investments, like high pressure processing units, cost up to 
$1.0 million to $1.5 million per unit. FSIS is using $1.5 million 
and $1.25 million as the expected capital costs of such equipment 
for large and small establishments, respectively. FSIS received 
comments regarding per-pound operating expenses for various post-
pasteurization processes, but was unable to use this information 
because of the lack of data on average production per establishment. 
FSIS assumes annual operating expenses are 10 percent of the initial 
capital cost.
    The changes in the industry (movement among establishment 
groups) reflected by the installation of post-lethality treatments 
are given in Table 14.
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[[Page 34243]]

    Cost to add agent or alter process to inhibit Listeria growth in 
the final product. One of the major impacts of the rule is that it 
encourages establishments in EG 4 to move into EG 2 by adding an 
agent or altering their production processes to inhibit Lm growth in 
the product. Adding such treatments would eliminate the need for 
more frequent verification testing. It is expected that 25 percent 
of the large and small establishments in EG 4 will move to EG 2 by 
doing so--3 large and 77 small establishments. The costs associated 
with this impact are subject to several factors. They include each 
establishment's unique situation with respect to product type, 
facility size, and equipment. Assuming that the cost to add agents 
or alter a process includes a one-time cost of installing equipment 
to add agents or alter production processes of $150,000 for a large, 
$125,000 for a small, and $100,000 for a very small establishment, 
the initial treatment cost totals $10.1 million. Using an operating 
cost of 10 percent of the initial cost produces a corresponding 
annual outlay of about $1 million (Table 15).
[GRAPHIC] [TIFF OMITTED] TR06JN03.024

    Cost of FCS testing for Listeria species. As with the third 
impact discussed above, the testing provisions of the rule encourage 
establishments to move from EG 4 into EG 1 and EG 2 (Table 16). 
These establishments are expected to be mostly small establishments 
attempting to avoid frequent FCS verification testing requirements 
for EG 4 establishments and the potential exposure to holding 
product upon two consecutive positive FCS verification test results. 
Almost half of the large establishments that were previously in EG 4 
are expected to migrate either to EG 1 or to EG 2.
    The costs of testing for the remaining 2,518 establishments in 
EG 3 and EG 4 are based on several assumptions. They include: the 
actual level of FCS verification testing being conducted at the 
present time, the percentage of establishments conducting this level 
of verification testing, the number of production lines by 
establishment size, and the costs of testing. The assumptions used 
in this analysis are supported by observations by FSIS inspection 
personnel and by various recent surveys conducted by FSIS and the 
industry. For example, in the recent FSIS hotdog and deli-meat 
survey, about 20 percent of large, 26 percent of small, and about 5 
percent of very small establishments stated that they conducted FCS 
verification testing for Listeria spp. The Lm growth inhibiting 
processes and ingredients used in producing these products probably 
lowers the level of verification testing being conducted by 
establishments producing other RTE MPPs. Therefore, FSIS believes 
that the actual proportion of establishments in EG 3 and EG 4 that 
conduct FCS tests is probably double the proportions reported in the 
recent hotdog and deli-meat survey for the small and very small 
establishments. That is, FSIS assumes that the current FCS 
verification testing levels for large, small, and very small RTE MPP 
producing establishments are 100 percent, 50 percent, and 10 
percent, respectively (See middle rows in Table 17).
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[[Page 34244]]

[GRAPHIC] [TIFF OMITTED] TR06JN03.025

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[[Page 34245]]

    Cost of Production Adjustments. As was discussed in the PRIA, it 
is expected that a series of Lm contamination events may occur in 
some establishments. The PRIA expected that most--about 85 percent--
of the establishments that obtain one positive FCS test result could 
remedy the cause of the Lm contamination at no additional cost 
through more stringent sanitation and handling techniques. The 
remaining 15 percent of establishments are expected to encounter a 
greater degree of difficulty. Some of these establishments (as 
discussed in the PRIA) will probably encounter Lm contamination 
problems that could be remedied at a cost of $2,000 per line (these 
establishments consist of 7 percent of the establishments 
experiencing at least one positive FCS verification test result); 
another 7 percent are expected to encounter more serious 
contamination problems that would need to be remedied by actions 
costing up to about \1/10\ of one percent of gross sales; and a 
final group made up of 1 percent of the establishments that discover 
that they have a chronic Lm contamination problem and have to cease 
their RTE MPP production altogether. No comments were received that 
would either support or refute this scenario or the set of 
assumptions needed in describing it. Some commented at the May 2001 
public meeting that inclusion of these possible eventualities would 
help complete the analysis. These results are expected to only apply 
to establishments in EG 4 who face the highest level of FCS 
verification testing. The underlying assumptions and resultant cost 
implications are given in Table 18.
    Some explanation of the cost estimates of this impact is needed. 
First, the calculations for cost estimates for minor remedies are 
the same as in the PRIA. That is, the number of firms in each 
establishment group is faced with a $2000 per line cost times the 
number of lines in the establishment for production adjustments. 
Second, the cost estimates for major repairs are slightly different 
from those in the PRIA. In the PRIA, the value of shipments for the 
1,479 establishments was available and estimated by Census at $25.2 
billion for 1999. In the PRIA, this value of shipments was 
distributed across the 133 large establishments, 840 small ones and 
506 very small ones using an average distribution for value of 
shipments by those size categories of 80-percent (for large), 15-
percent (for small), and 5-percent for very small). This average 
distribution was derived from averages across broad categories of 
agricultural commodities. A much different distribution of value of 
production was found in the Fall 2002 FSIS survey of hotdog and deli 
meat establishments. It found a value of production distribution of 
48-percent (large), 48-percent (small), and 4-percent (very small). 
The final regulatory impact analysis uses a distribution of 65, 35, 
and 5 in conjunction with the original $25.2 billion for total value 
of shipments. This calculation produced average per establishment 
value of shipment estimates of $123 million for large 
establishments, $9 million for small establishments, and $2 million 
for very small establishments. This estimate is important because it 
serves as the basis for calculating the costs to remedy the major 
cases of Lm contamination. As in the PRIA it is expected that a 
small number of establishments whose contamination problems will be 
perceived to be prohibitively costly to ``fix'' and/or not feasible 
to undertake without complete modernization or renovation. Without 
making these needed capital improvements, their only option is to 
either partially or entirely cease RTE MPP production. FSIS expects 
that up to two small and four very small establishments may be in 
this situation.
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[[Page 34246]]

[GRAPHIC] [TIFF OMITTED] TR06JN03.026

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[[Page 34247]]

    Costs related to possible hold-and-test actions. Hold-and-test 
actions are expected to be taken by establishments in EG 4 and to a 
lesser extent in EG 3. For purposes of this analysis, 50 percent of 
the EG 3 and 95 percent of the EG 4 establishments that are expected 
to have some problems with Lm contamination are also expected to be 
faced with one or more hold and test events annually. This 
calculation suggested that seven small and 79 very small 
establishments in EG 3 and one large establishment and 29 small and 
63 very small establishments in EG 4 are expected to take one or 
more hold-and-test actions over a typical year. In addition to the 
number of establishments affected, there are five other factors that 
affect this cost impact. These are: (1) The amount of production 
likely affected (based on the number of lines times number of shifts 
and production per shift estimates); (2) the pounds per pallet that 
will need to be handled and placed into storage; (3) the average 
number of days that the product will be held in storage; (4) the 
number of times per year that a hold-and-test action occurs; and, 
(5) the cost per day per pallet in handling and storage. Also, the 
amount of existing available storage will influence any expected 
burden placed on establishments. The recent FSIS hotdog and deli-
meat survey found that up to 40 percent of establishments have 
sufficient storage to hold product, but for only one to two days of 
production. Even though this finding only reflects the capacity of 
hotdog and deli-meat establishments, FSIS does not anticipate any 
serious problems with establishments finding available storage for 
holding product under possible increased hold-and-test situations on 
their premises or at other locations. FSIS bases its estimate for 
expected industry-wide costs of hold-and-test on parameters stated 
in Table 19. These costs are intended to include the transportation, 
handling and storage costs associated with product that has been 
tested and may or may not prove to be contaminated with Lm. For 
example, the $119,500 cost calculation for hold and test expected to 
be incurred by very small establishments was made by multiplying the 
expected number of affected establishments (79) times the number of 
expected hold and test occurrences per year (3) times the daily cost 
of holding (5 days times 5.6 pallets times $18 per pallet per day). 
Similar calculations were made for other affected establishments in 
the other HACCP establishment size categories and establishment 
groups. FSIS does not consider that the costs associated with the 
handling and eventual disposition of contaminated product, including 
its possible destruction, should be attributed to this final rule. 
It is believed that this product would have or should have been 
discovered and appropriately disposed of under current good 
manufacturing practices had they been followed by the establishment. 
Also to the extent that some of these products are normally 
refrigerated, these holding cost estimates would over-estimate the 
impact on the industry.
[GRAPHIC] [TIFF OMITTED] TR06JN03.027


[[Page 34248]]



Analysis of Alternatives

    For purposes of the analysis, the expected frequency of FCS 
verification testing for Listeria spp. for establishments in EG 2 is 
once per line per quarter; for EG 3, at least once per line per 
month; and for EG 4, once per line per month for very small 
establishments; semi-monthly for small producing establishments and 
weekly for high volume producing establishments (4-2-1). These 
testing frequencies are to be considered minimum expected levels for 
the purposes of estimating costs and benefits. Conditions may 
warrant a higher frequency of FCS verification testing to assure 
FSIS that establishments' sanitation or prerequisite plans are 
adequately addressing the risk of possible contamination in its 
products. As an additional precaution, FSIS is requiring that after 
a second positive Listeria spp. FCS test result in an EG 4 
establishment, hold and test actions are taken until such time that 
FSIS is assured that this action is no longer needed.
    The FSIS Lm Risk Assessment found an increase in median lives 
saved as FCS verification testing frequencies increase relative to 
the baseline. The minimum FCS verification testing frequency for EG 
4 (4-2-1) results in 25 deaths averted if there is 100 percent 
adoption of this testing frequency by all establishments producing 
deli meats.
    An alternative FCS verification testing frequency could be 40-
20-10 for EG 4. In this case, the reduction in human health risk 
increases to 89 deaths averted, given 100 percent adoption. At an 
extremely high level of testing, such as 60-60-60 (for either FCS 
verification testing for Listeria spp. or product testing for Lm), 
153 deaths are averted given 100 percent adoption. Also, at these 
high levels of FCS verification testing, hold and test protocols 
were shown to reduce the level of Lm contamination at retail.
    Extremely high FCS verification testing levels may not be 
required to assure adequate sanitation. Nor are they necessarily 
effective from an economic perspective. Costly hold and test actions 
increase with FCS verification testing frequency. As such costs 
increase, establishments producing RTE MPPs, especially small and 
very small establishments, may eliminate product lines or cease 
production entirely. FSIS recognizes, however, that FCS verification 
testing frequencies higher than 4-2-1 may be appropriate for 
establishments with a history of poor sanitation controls or 
evidence of producing adulterated product.
    Another concern about high FCS verification testing frequencies 
is the likelihood that many establishments that produce RTE MPPs 
using traditional methods will no longer produce such products. To 
the extent that this reduces the amount of adulterated product, this 
rule and its emphasis on FCS verification testing is appropriate. It 
may be inappropriate for any product that FCS testing for Listeria 
species is not a reliable indicator for Lm product contamination. 
FSIS believes that its establishment categorization in this final 
rule will place only those products in EG 4 where intense sanitation 
and verification testing is most appropriate. However, extremely 
high verification testing frequencies in most cases may be 
unnecessary and burdensome.
    The risk assessment clearly shows that a combination of post-
lethality treatment or Lm growth inhibition along with sanitation 
and FCS verification testing and other measures is more effective 
than a ``sanitation coupled with FCS verification testing only'' 
strategy. This result also reinforces the observed industry practice 
of maintaining a series of adequate precautions throughout slaughter 
and processing, and of not exclusively relying on verification of 
sanitation through FCS testing alone to assure that products are not 
adulterated. FCS verification testing of sanitation procedures for 
Listeria species can compliment these other measures, e.g. post 
processing pasteurization, the addition of Lm growth inhibiting 
packaging. To the extent that establishments take a series of steps 
to address their possible Lm contamination, the need for higher FCS 
verification testing frequencies, and its impact of inspection 
personnel to review these data, is reduced.

Summary of Direct Industry Costs

    The PRIA identified three major possible industry-wide impacts 
from mandatory FCS verification testing: HACCP plan modification 
costs ($1.28 million); direct testing costs ($1.75 million); and, 
production adjustments ($2.5 million). The total first-year cost of 
these impacts was $5.53 million--$3.8 million in one-time outlays 
and $1.75 million in recurring annual costs associated with testing.
    The Final Regulatory Impact Analysis (FRIA) reflects many 
comments received in the public comment period. In addition to the 
impacts identified in the PRIA, the FRIA estimates (1) the cost of 
PL treatments (initial and annual operating); (2) the cost of using 
an agent or process to inhibit Lm growth (initial and annual 
operating); and, (3) the costs of holding product while awaiting 
confirmation of FCS verification testing.
    The validation of PL treatments and related HACCP plan 
modifications results in a one-time cost of $2.6 million. The 
estimated cost in the FRIA is higher than that in the PRIA due to an 
increase in the number of establishments affected. The FRIA estimate 
may be conservative as it does not take into account the use of 
validation studies conducted by PL equipment manufacturers. Direct 
testing costs are substantially lower than estimated in the PRIA 
($175,260 versus $1.75 million) because the expected movement of 
establishments out of EG 4 and into the other establishment groups 
where higher FCS verification testing is not expected. Production 
adjustments are estimated at $1.15 million in one-time costs in the 
FRIA compared to $2.5 million in the PRIA. The difference is due 
mainly to fewer expected cases where establishments are not able to 
overcome their Lm contamination problem. More establishments adopt 
PL treatments and move into EG 1 or EG 2. The total of the two, one-
time cost components (production adjustments and use of PL 
treatments) is the same as that estimated in the PRIA ($3.8 million 
as opposed to $3.75 million estimated in the PRIA). Verification 
testing costs, as noted above, are substantially lower than that 
estimated in the PRIA.
    The additional costs associated with the installation of PL 
treatments and/or altering their production to incorporate an agent 
or process to inhibit Lm growth introduces potentially large cost 
outlays, especially for the initial, one-time investments in plant 
and equipment (Table 20). The initial industry-wide, one-time cost 
outlays for equipment associated with production adjustments and PL 
treatments are expected to be as high as $51.6 and $10.1 million, 
respectively. The annual operating (recurring) costs of $5.2 and $1 
million, respectively, make first-year costs for these two 
technologies, $56.7 and $11.1 million, respectively.

[[Page 34249]]

[GRAPHIC] [TIFF OMITTED] TR06JN03.028

    Converting initial costs into an annual equivalent cost of 
capital recovery provides a more accurate measure of economic 
impacts.\8\ Using a 7-percent discount rate over ten years results 
in annualized cost of $9.3 million for PL validation, installation, 
agent and/or process alteration cost, and production adjustments. 
The annual operating (recurring) costs are estimated at $7.3 
million. Combining these two estimates produces a total annual cost 
of the final rule of $16.6 million (bottom of Table 21).
---------------------------------------------------------------------------

    \8\ Lynn E. Bussey, The Economic Analysis of Industrial 
Projects, Engelwood Cliffs, New Jersey, 1978.
[GRAPHIC] [TIFF OMITTED] TR06JN03.029

Possible Indirect and Unintended Cost Impacts

    The focus of the cost discussion thus far was mainly on 
industry-wide direct compliance costs: These costs, on an annual 
basis, were estimated at $16.6 million, roughly one-half of one 
percent of the total annual value of industry sales ($16.6 million 
divided by $25.2 billion). In addition, some discussion was made of 
the possible impacts that the final rule may have on lowering 
product quality, reducing current FCS testing frequencies in some 
establishments, and forcing some establishments to exit the 
industry. However, these impacts were not quantified. Two other 
possible indirect cost impacts are on consumers and other sectors of 
the economy.
    No market product quantity and price data are available to 
calculate the possible consumer price implications brought about by 
the higher compliance costs identified in this analysis. This 
information, plus an estimation of any reduction in market supplies, 
could be used to calculate the social costs of shifts in supply and 
demand in a consumer- and producer-surplus framework. Also, a 
complicating factor in estimating possible market supply reductions 
is to what extent imported product could be substituted for any U.S. 
RTE MPP production cutback. Without such information, one can only 
say that higher industry compliance

[[Page 34250]]

costs and lower market supplies would be expected to raise consumer 
prices to some extent. From the information provided in this 
analysis (the expected small cost impacts relative to total value of 
production and the likely small quantity cut-backs), it is expected 
that these impacts would be minimal.
    A related issue is the possible impact on other sectors of the 
economy. Census data show that swine, beef, dairy, and poultry 
industries supply significant amounts of raw product to the RTE MPP 
industry. Because, however, the quantity effect is expected to be 
minimal, these upstream suppliers of raw material are not expected 
to be significantly affected by the final rule.

Analysis of Benefits

    The analysis of benefits resulting from the final rule examines 
the reduction in human health risk (deaths and illnesses caused by 
listeriosis) from actions taken as a result of this final rule by 
RTE MPP establishments in only one product group: deli meats 
(primarily sliced luncheon meats). This analysis of benefits thus 
differs from that in the PRIA which examined the reduction in human 
health risk from all RTE MPPs.
    FSIS is focusing on deli products for several reasons. First, 
the FDA-FSIS risk assessment identified this product group as having 
the highest risk of all food classes and the cause of a large share 
of listeriosis deaths and illnesses. Second, the FSIS Lm Risk 
Assessment, when calibrated to a revised version of FDA-FSIS risk 
assessment, tied risk mitigation actions at deli-meat producing 
establishments to potentially lower rates of listeriosis death and 
illnesses. FSIS plans to modify the model to capture the dynamics of 
Lm contamination and containment in other RTE MPP products, such as 
hotdogs, along with the impact of production volume. Third, the FSIS 
Lm Risk Assessment, having been presented to the public for comment, 
has been revised to the extent possible at this time.
    The analysis of benefits uses the FSIS Lm Risk Assessment to 
evaluate the human health risk reduction effects of sanitation 
coupled with FCS verification testing, the use of growth inhibiting 
packaging (GIP); and the use of PL treatments. The likely reduction 
in listeriosis deaths from a 100-percent adoption of these practices 
and treatments by the industry is given in Table 22. FSIS is 
reporting three values for the possible benefits derived from this 
rule: The median, the 5th percentile, and the 95th percentile for 
each scenario (baseline, sanitation/FCS verification testing, Lm 
growth-inhibiting packaging (GIP) and post-lethality processing (PP) 
+ GIP). This range of values represents the uncertainty in the true 
number of averted number of deaths per year. The reported results 
imply 90 percent certainty that the true value lies between the 5th 
and 95th percentiles. Each uncertainty distribution is the result of 
three hundred computer simulations, each simulation consisting of 
100,000 iterations, of the FDA-FSIS risk ranking model. The risk 
characterization portion of that model comprises 4,000 combinations 
of the exposure distributions for the 23 different food groups in 
the FDA-FSIS risk ranking model. The median reports the mid-point 
value of deaths averted from these multiple computer simulations for 
each scenario. The median is reported because it is the preferred 
measure of central tendency in the FDA-FSIS risk ranking. 
Furthermore, the distribution of results suggests that the mean, as 
an alternative measure of central tendency, is less informative 
about the shape of the distribution because of the influence of 
outliers in its calculation. Illnesses are estimated using the 
standard .20 case-fatality rate commonly reported in the literature.
[GRAPHIC] [TIFF OMITTED] TR06JN03.030

    The greatest reduction in listeriosis deaths and illnesses would 
occur if all establishments used both PP and GIP. However, 100 
percent adoption is not possible for a variety of reasons, including 
technical--not all products are amenable to the use of PL or GIP--
and economic--the costs are prohibitive in relation to the value of 
the product.
    The analysis of costs described movements among establishment 
groups that are likely to occur as a result of the final rule. These 
movements are the basis for estimating the human health benefits of 
the final rule. Establishment group net movements are placed on a 
percentage basis of establishments in each size class (Table 23). 
The absolute changes in establishment numbers are converted into 
percentage increases by dividing the number establishments estimated 
to adopt one or more measures by the total number of establishments 
in that size class. For example, 2 of the 42 large establishments 
producing deli meats (4.8 percent) are estimated to adopt PL and GIP 
measures. Next, the percentage change in establishments is weighted 
by the relative volume of deli meats produced by that size class. 
The two large establishments are estimated to account for 2.3 
percent of deli-meat production (4.8 times 0.48). The summation of 
these weighted percentages produces the percentage increase in that 
technology which is adopted as a result of the final rule. Thus, 
deli-meat producing establishments adopting PL and GIP represent a 
5.4-percent increase in the amount of deli-meat production that is 
produced using this technology. Likewise, the percent increase in 
the amount of production using GIP and FCS sanitation/verification 
testing is 8.9 and 13.3 percent, respectively.

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    The results in Tables 22 and 23 are used to estimate the 
possible reduction in listeriosis deaths that may be attributed to 
actions taken be deli-meat producing establishments as a result of 
the final rule (Table 24).
    This analysis excludes neonate deaths estimated by the FSIS risk 
assessment because of concerns about using the standard values for a 
statistical life, which are derived from adult lives. Of course, it 
is obvious that averting such neonate losses is a potentially 
significant benefit. However, excluding these losses does not 
substantially affect the conclusions of this analysis.
    Calculations combining information from Tables 22 and 23 are 
fairly straightforward: for example, the 13.3 percent increase in 
adoption rates of sanitation coupled with FCS verification testing 
translates into 3.1 fewer listeriosis deaths at the median (0.133 
from Table 23 times 24 from Table 22); 1.0 fewer at the 5th 
percentile (0.133 x 8.0); and, 3.1 fewer at the 95th percentile 
(0.133 x 24). Similar calculations for the other two mitigation 
measures result in a total reduction of 27.3 at the median; 8.9 at 
the 5th percentile; and, 31.2 at the 95th percentile. The 
corresponding reductions in illnesses are 136.7 at the median, 44.6 
at the 5th percentile, and 156.0 at the 95th percentile, 
respectively.
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    The Economic Research Service of USDA presented a method for 
estimating the human health benefits of reduced listeriosis at a 
public meeting on the proposed rule held in May 2001. To estimate 
the benefits, it was assumed that 5 percent of the cases were 
moderate, and that moderate cases resulted in hospital costs of 
$10,300 per case. The remaining 95 percent of the illness were 
severe, resulting in hospital costs of $28,300 per case.\9\ Using 
these assumptions and excluding the loss in productivity of those 
affected and any pain and suffering, the benefits of the reduction 
in illness-related losses due to the final rule are estimated to be 
$3.7 million at the median (0.05 x 136.7 x $10,300) + (0.95 x 136.7 
x $28,300)) and $1.2 million at the 5th and $4.3 million at the 95th 
percentile.
---------------------------------------------------------------------------

    \9\ Stephen Crutchfield, ``The Benefits of Reducing Listeria in 
Ready to Eat Products.'' 2001. Presented at public meeting, 
``Performance Standards for the Production of processed Meat and 
Poultry Products,'' May 9-10, 2001. FSIS-USDA Washington, D.C. 
Roberts, Tanya, and Robert Pinner. Economic Impact of Disease Caused 
by Listeria monocytogenes.'' In Miller, AJ, Smith JL, and Somkuti 
GA, (Eds.) Foodborne Listeriosis. Amsterdam, the Netherlands: 
Elsevier Science Publishing Co., 1990, pp. 137-144.
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    ERS estimated the value of statistical life at $4.8 million \7\ 
as a proxy for the cost of one fatality. Based on this estimate, the 
annual human health benefits from the implementation of the final 
rule are $134.9 million at the median (the $3.7 million above plus 
27.3 x $4.8 million) and $44.0 million at the 5th percentile and 
$154.0 million at the 95th percentile.
    Given the limitations in data and the output of the risk 
assessment dealing only with deli meats and as per the discussion 
found earlier concerning the estimates of health consequences, FSIS 
believes that this estimate may be overstated by as much as 50 
percent. If so, the adjusted annual net benefits then become $50.8 
million, $5.4 million and $60.4 million at the median, 5th and 95th 
percentile levels, respectively (Table 25). It appears that a 
downward adjustment in total benefits of 85 percent would be 
necessary to lower net benefits to near zero.
[GRAPHIC] [TIFF OMITTED] TR06JN03.033

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 rule will have a 
significant economic impact on a substantial number of small 
entities. As discussed above, FSIS estimates that the Lm sanitation 
coupled with FCS verification testing provisions of this final rule 
may result in annual costs to small and very small producers of 
post-lethality exposed RTE MPPs of $12.5 and $0.6 million, 
respectively. These establishments incur about 79 percent of the 
total industry-wide costs of compliance with the sanitation coupled 
with FCS verification testing provisions of this final rule.
    The Small Business Regulatory Enforcement Fairness Act of 1996 
(Pub. 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 must publish one or more guides to 
assist small entities in complying with the rule, and must designate 
such publications as ``small entity compliance guides''. The guides 
must explain the actions a small entity is required to take to 
comply with a rule or group of rules. FSIS is developing guidance to 
assist small and very small establishments in fulfilling their 
responsibilities under the final rule. The guides will include 
instructions on how establishments that produce post-lethality 
exposed RTE MPPs can conduct sanitation coupled with FCS and product 
verification testing. Establishments that wish to use the guides may 
incorporate their features into their HACCP plans, Sanitation SOPs 
or other prerequisite programs. Because FSIS is basing its guidance 
on existing research and industry practices that are known to be 
effective, the Agency also will consider the processing instructions 
to be already validated. That is, an establishment may follow the 
guidance without contracting for or conducting additional validation 
of the content of the materials.
    FSIS is examining other options to minimize the potential 
negative economic effects of these proposed regulations on small 
businesses, including encouraging research that would facilitate 
validation of pathogen lethality in many products, especially those 
produced by traditional methods by small and very small 
establishments.
    Types of Entities and Production Affected by the Final 
Regulations. The preliminary RIA found that small and very small 
establishments made up about 91 percent of the number of 
establishments in the U.S. RTE MPP industry and were expected to 
incur up to 69 percent of the cost of complying with the 
requirements of the proposed rule. The FRIA finds that small and 
very small establishments make up about 97 percent of the number of 
establishments in the industry and are expected to incur nearly 80 
percent of total cost impact on the industry. As was also stated in 
the FRIA, the final rule only involves that part of the original 
proposal dealing with FCS verification testing for Lm or indicator 
organism and also uses a more accurate baseline for the number of 
establishments affected by the final rule.
    An important note to consider throughout this analysis is that 
much of the projected impacts originate from expected movements of 
establishments from one establishment group to another. As was 
stated in the

[[Page 34253]]

preliminary RIA, ``mandatory Listeria 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, the 
degree to which firms will be able to resolve their Listeria-related 
problems if they present themselves, and the degree to which they 
must increase their testing.'' This problem is further compounded in 
this analysis because the final rule is not limited to whether 
establishments either elect to incorporate a Lm-related CCP in their 
HACCP plan or face mandatory testing. In this analysis, it is 
possible for establishments to address possible Lm contamination in 
their operations through a variety of methods.
    A large share of the cost impact is on small establishments, 
which are expected to absorb nearly 75 percent of the total 
industry-wide cost impact (Tables 26 and 27). These establishments 
have the same incentives to move to new post-pasteurization 
technologies as do very small establishments, but their production 
volumes more easily justify the associated high capital and 
recurring expenditures. Very small establishments will likely have 
to increase sanitation coupled with FCS verification testing to 
comply with this final rule. Large establishments are likely to 
complete the process of adopting new technologies. The expected 
impacts on large, small, and very small establishments are discussed 
below.

Large Establishments

    As discussed in the ``Baseline'' section of this analysis, most 
(131 out of 144 large establishments) already fall into either 
establishment group 1, 2 or 3. This number is expected to increase 
by 5 establishments as a result of the final rule, leaving only 8 
establishments in the establishment group 4: those establishments 
required to conduct more intense sanitation coupled with FCS L. spp. 
verification testing than establishments producing product in the 
other establishment groups. Many of these firms already employ post-
pasteurization technologies, but need them validated to comply with 
the final rule. In fact, six of the existing establishments in EG 1 
and four of the establishments from EG 2 already employ the 
technology, but simply have not validated their processes. It is 
expected that total validation costs will run about $749,000 in 
first-year costs for these establishments.
    The remaining establishments are likely to have high enough 
product volume levels to justify the acquisition of new post-
pasteurization technologies and/or to alter product formulations and 
packaging. The remaining eight establishments (seven of the 10 
establishments from EG 2 (or 10 percent of the establishments in EG 
2 that do not apply a post-pasteurization step)); and one from EG 4 
(or 10 percent of the establishments in EG 4) all are expected to 
need post-pasteurization equipment and have their processes 
validated. The resulting large initial cost outlays plus the 
estimated recurring annual operating costs are expected to total 
$14.3 million in first-year costs. This cost represents about 90 
percent of all the costs that are expected to be incurred by large 
establishments as a result of this final rule. The remaining costs 
are incurred by those establishments electing to add an inhibiting 
agent or process in their production or to a lesser degree, as a 
result of sanitation coupled with FCS verification testing and 
possible subsequent actions related to hold and test and finding 
remedies to possible persistent Lm contamination problems.

Small Establishments

    It is estimated that there are 1,276 small establishments 
producing RTE MPPs. FSIS estimates that 108 small establishments 
will migrate to other establishment categories as a result of the 
final rule. This is a costly undertaking, especially for those 
establishments that elect to migrate into EG 1. Due to the high cost 
of both technologies (post-lethality processing and adding an agent 
or process to the product) and because their products must conform 
to both process adjustments, it is expected that only 31 
establishments (or 10 percent of the small establishments that were 
formally in EG 4) migrate to EG 1 as a result of the final rule. All 
movement involves the purchase and use of new technology which is 
expected to cost these establishments over $42 million. About twice 
the number of establishments that is expected to migrate to EG 1 is 
expected to migrate to EG 2. This move is less costly and it is 
expected that more RTE MPPs lead themselves to the addition of an 
inhibiting agent or process. These 77 establishments are expected to 
incur $10.6 million in first-year, total direct and recurring costs. 
All of the 108 establishments are expected to migrate from EG 4.

Very Small Establishments

    It is estimated that there are 3,556 very small establishments 
producing RTE MPPs. The preliminary RIA had an estimate of only 524 
establishments, acknowledging that that estimate severely 
underestimated the true number of very small establishments. Due to 
the combination of high costs and technical difficulties faced by 
very small establishments, FSIS projects that no very small 
establishments will shift into a different establishment group. 
Consequently, FSIS does not expect that very small establishments 
will incur any costs associated with the adoption of post lethality 
treatment methods or by incorporating an inhibiting agent or process 
in their production. Instead, most of the entire cost impact of this 
final rule on very small establishments is expected to originate 
from sanitation coupled with FCS verification testing and the 
possible production adjustments and additional handling and storage 
associated with increased testing and the higher likelihood of 
incurring Listeria species positive FCS test results. A small amount 
of costs are expected to be incurred by those very small 
establishments that currently employ un-validated post-lethality 
processing technologies.

Summary

    Small establishments make up 26 percent of the establishments, 
yet are expected to incur up to 75 percent of the aggregate cost 
burden. Much of these expected costs are in large capital 
expenditures in post lethality processing equipment and in changing 
their production process to incorporate Lm growth inhibiting agents 
or processes. This cost impact would be reduced to the extent that 
these cost estimates over-estimate the actual costs of acquiring 
these technologies or over-estimate the establishment movements. It 
is unlikely that actual cost impacts would exceed those estimated in 
this analysis. Very small establishments make up 71 percent of the 
number of establishments in the industry and yet are expected to 
incur only 4 percent of the total costs of this final rule. This 
estimate may under-estimate their exposure to cost increases related 
to FCS testing. Thus, it is unlikely that actual cost impacts would 
be lower than those estimated in this analysis. The estimates for 
large establishments are highly contingent on their movement into 
EG1 and EG2. To the degree that actual movements into these 
establishment groups occur, the estimates in this analysis should 
reflect these expected cost outlays.
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[FR Doc. 03-14173 Filed 6-5-03; 8:45 am]
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