[Federal Register: June 6, 2003 (Volume 68, Number 109)]
[Rules and Regulations]
[Page 34207-34254]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06jn03-20]
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Part V
Department of Agriculture
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
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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
[[Page 34210]]
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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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 http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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 34229]]
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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.
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\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 http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=www.fsis.usda.gov.
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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
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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.
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\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.
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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]]
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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 34242]]
[GRAPHIC] [TIFF OMITTED] TR06JN03.023
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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
BILLING CODE 3410-DM-C
[[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.
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\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.
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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
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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.
BILLING CODE 3410-DM-P
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[FR Doc. 03-14173 Filed 6-5-03; 8:45 am]