[Federal Register: July 25, 1996 (Rules and Regulations)]
[Page 38956-38989]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25jy96-22]
[[pp. 38956-38989]] Pathogen Reduction; Hazard Analysis and Critical Control Point
(HACCP) Systems
[[Continued from page 38955]]
[[Page 38956]]
The estimated annual industry costs (not discounted) are summarized
in Table 2. These annual costs vary over the first four years as the
new HACCP-based program is undergoing its implementation phase. After
the initial four years, the recurring costs are estimated at a constant
$99.6 to $119.8 million per year. The present value of all industry
costs summarized in Table 2 for the 20-year time period is $968 to
$1,156 million as shown earlier in Table 1. This total of $968 to
$1,156 million ($0.97 to $1.16 billion) is the total industry cost for
the rule as shown in Table 3.
TABLE 2.--Summary of Annual Industry Costs--All Requirements
[$ Thousands]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cost Category Year 1 Year 2 Year 3 Year 4 Year 5+
--------------------------------------------------------------------------------------------------------------------------------------------------------
I. Sanitation SOP's:
Plans and Training................................... 2,992
Observation and Recording............................ 8,345 16,691 16,691 16,691 16,691
II. E. coli Sampling:
Plans and Training................................... 2,627
Collection and Analysis.............................. 8,716 16,122 16,122 16,122 16,122
Record Review........................................ 406 752 752 752 752
III. Compliance with Salmonella Standards................ ................. 5,472-16,899 5,353-25,753 5,811-25,956 5,811-26,079
Compliance with Generic E. coli Criteria............. ................. (\1\) (\1\) (\1\) (\1\)
IV. HACCP:
Plan Development..................................... ................. 3,769 27,755 35,464 .................
Annual Plan Reassessment............................. ................. ................. 69 448 1,179
Initial Training..................................... ................. 1,270 8,284 18,435 .................
Recurring Training................................... ................. 64 542 1,877 2,799
Recordkeeping (Recording, Reviewing and Storing Data) ................. 3,050 18,479 42,478 54,097
V. Additional Overtime................................... ................. 189 837 1,711 2,125
----------------------------------------------------------------------------------------------
Total.............................................. 23,086 47,379-58,806 94,884-115,284 139,789-159,934 99,576-119,844
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Not Separately Estimated.
Table 3.-- Present Value of 20-Year Costs and Benefits
[$ Billions]
------------------------------------------------------------------------
Public health
Effectiveness in reducing pathogens in the benefits Industry
manufacturing sector (percent) ---------------- costs
Low High
------------------------------------------------------------------------
10.......................................... 0.71 2.66 0.97-1.16
20.......................................... 1.43 5.32 0.97-1.16
30.......................................... 2.14 7.98 0.97-1.16
40.......................................... 2.85 10.64 0.97-1.16
50.......................................... 3.57 13.30 0.97-1.16
60.......................................... 4.28 15.96 0.97-1.16
70.......................................... 4.99 18.61 0.97-1.16
80.......................................... 5.71 21.27 0.97-1.16
90.......................................... 6.42 23.93 0.97-1.16
100......................................... 7.13 26.59 0.97-1.16
------------------------------------------------------------------------
Note: Analysis assumes zero benefits until year 5. All elements
of the HACCP-based program will be in place 42 months after
publication of the final rule.
The public health benefits of this rule are discussed in detail in
Section IV. The benefits are based on reducing the risk of foodborne
illness due to Campylobacter jejuni/coli, Escherichia coli 0157:H7,
Listeria monocytogenes and Salmonella. Section IV concludes that these
four pathogens are the cause of 1.4 to 4.2 million cases of foodborne
illness per year. FSIS has estimated that 90 percent of these cases are
caused by contamination occurring at the manufacturing stage that can
be addressed by improved process control. This addressable foodborne
illness costs society from $0.99 to $3.69 billion, annually. The high
and low range occurs because of the current uncertainty in the
estimates of the number of cases of foodborne illness and death
attributable to the four pathogens. Being without the knowledge to
predict the effectiveness of the requirements in the rule to reduce
foodborne illness, the Department has calculated projected health
benefits for a range of effectiveness levels, where effectiveness
refers to the percentage of pathogens eliminated at the manufacturing
stage. The link between effectiveness and health benefits is the
proportionate reduction assumption which is explained in Section IV.
Because of the wide range in estimates for the cost of foodborne
illness, each effectiveness level will have a low and high estimate for
public health benefits. These estimates of public health benefits are
shown in Table 2, as the present value of a 20-year benefit stream.
The analysis assumes that benefits will begin to accrue in year
five. The five year lag leads to conservative benefit estimates since
the new HACCP-based inspection program will be fully implemented in 42
months, and benefits should accrue during those 42 months as well as in
the 1\1/2\ years that follow. Limiting the benefit estimates to four
pathogens also leads to conservative cost estimates. To the extent that
the proportionate reduction estimate may overestimate benefits, these
other factors provide conservative balance.
Net benefits exist for every cost and benefit combination
illustrated in Table 2 except for the case of 10 percent effectiveness
using the low benefit estimate. If the low benefit estimate is correct,
the new HACCP-based regulatory program would have to reduce pathogens
by 14 to 17 percent to cover the projected 20-year industry costs of
$968 to $1,156 million. For the high benefit estimate net benefits
begin to occur at an effectiveness level of 4 to 5 percent.
The costs summarized in Tables 1 and 2 have not been reduced to
account for firms that already have existing HACCP programs. FSIS does
not have a good estimate of the number of such firms.
C. Impact on ``Smaller'' Businesses
The final rule provides regulatory flexibility for smaller firms
consistent with the Regulatory Flexibility Act. For the slaughter
facilities, the generic E. coli sampling requirements vary depending on
the number of birds or animals slaughtered annually. This will
significantly reduce the microbial
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testing costs for smaller establishments which, under the proposed
rule, would have been required to test every species or kind they
slaughter every day on which slaughter of that species or kind occurs.
Under the final rule, the impact on smaller establishments is mitigated
by the change to base generic E. coli sampling requirements on annual
production and by a change to no longer require that every species or
kind be sampled. The costs to small establishments are also reduced
because the proposed carcass cooling and antimicrobial near term
requirements have been eliminated from the final rule and training
requirements are more flexible. The requirement to sample each variety
of raw ground product, which caused a heavier burden on small
establishments, has also been eliminated.
The regulatory burden on small establishments is eased by the
provisions which extend the time small establishments have to meet the
HACCP system requirements. The detailed cost analysis in Section V
outlines the methodology used in developing cost estimates and varying
regulatory requirements for the purpose of regulatory flexibility for
small establishments.
D. Effect on Retail Price
The preliminary analysis included an estimate that the total four-
year implementation costs represented only $0.0024 per pound of fresh
meat and poultry. This type of estimate helps put overall cost figures
into perspective in terms of the potential increase in food prices. A
large number of smaller processors responded very emotionally to the
low figure of $0.0024 per pound on the basis that the lack of economies
of scale in their businesses means their potential unit cost increases
would be far higher. This ``cost-per-pound'' analysis was not meant to
imply that the cost impact on all business would be the same. In a
competitive industry, the impact on overall retail price is, however,
an important indicator of net societal benefits. The four-year
implementation costs for the final rule represent $0.0011 to $0.0013
per pound based on 1993 production of 67.15 billion pounds (66.4
billion pounds federally inspected and 748 million state inspected) of
meat and poultry on a carcass weight basis. The annual recurring cost
of $99.6 to $119.8 million represents $0.0015 to $0.0018 per pound
based on 1993 production.
E. Impact on International Trade
The final rule will have an impact on countries and the
establishments in those countries that export meat and poultry products
to the United States. The inspection statutes require that imported
product be produced under an inspection system that is equivalent to
the U.S. inspection system. The equivalence of a country's system must
be established by the United States before product can be exported to
the United States. The notion of equivalence has been clarified under
the World Trade Organization (WTO) Agreement on Sanitary and
Phytosanitary measures. Under the WTO, all members have an obligation
to apply the principle of equivalence on importing countries.
Equivalence determinations are based on scientific evidence and risk
assessment methodologies.
In light of the WTO emphasis on the use of science to determine
equivalence, a number of countries are moving toward implementation of
HACCP systems. The preliminary analysis noted that a large portion of
the eligible exporting establishments are in countries that are
themselves in the process of implementing HACCP and complying with
their own country's HACCP requirements may achieve equivalence with the
requirements of this rule.
As of January 1, 1995 there were 1,395 establishments in 36
different countries certified to export meat or poultry products to the
United States. Canada (599 establishments), Denmark (125
establishments), Australia (111 establishments) and New Zealand (94
establishments) accounted for two-thirds of the 1,395 establishments.
These four countries were the source of 85 percent of the 2.6 billion
pounds of product imported during 1994. These four countries are
currently developing HACCP systems for their respective inspection
programs.
Half (18) of the 36 countries have fewer than 10 establishments
approved to export products to the U.S. These 18 countries represent a
total of 77 establishments, 5 percent of the total. Meeting the
equivalency requirements may present a problem for some of these
countries in the near term. Their inspection programs will have to meet
equivalency requirements for HACCP according to the implementation
schedule for domestic establishments, i.e., 18 months for large
establishments, 30 months for small establishments and 42 months for
very small establishments. This schedule should lessen the burden on
smaller establishments.
There are other factors that will affect the burden on foreign
establishments. As HACCP becomes the international norm, these
establishments will be required to implement changes to meet the
requirements of other countries implementing HACCP. Thus, their costs
may not be solely associated with U.S. requirements. Establishing
impact is further complicated because the U.S. requirements apply only
when they are preparing product that is to be exported to the U.S. This
product may represent only a small portion of total establishment
production.
Upon implementation of these regulations, FSIS will review other
countries' meat and poultry systems to ensure that exporting countries
have adopted comparable measures, which would entitle them to continue
exporting product to the United States. As other countries improve
their regulations by adopting provisions comparable to those contained
in this rule, it is expected that U.S. exports will similarly be
affected, i.e., the receiving countries will be closely reviewing
domestic exporting establishments to assure that they are meeting the
requirements of the importing country.
FSIS will continue to carry out its import inspection
responsibilities with a two-stage approach. The first stage is system
review, which consists of an evaluation of the laws, policies, and
administration of the inspection system in each eligible country. This
overall evaluation will include an assessment of the implementation of
HACCP supplemented by on-site reviews of individual establishments,
laboratories, and other facilities within the foreign system. The
``equivalency'' of foreign requirements will be determined at this
stage.
The second level of review involves port-of-entry inspection by
FSIS inspectors to verify the effectiveness of foreign inspection
systems. Using statistical sampling plans based on the foreign
establishment's history and the nature of the product, FSIS will
continue to give greater scrutiny to shipments posing the highest risk.
Products that do not meet U.S. requirements, which includes having been
produced under a HACCP or HACCP-equivalent system, will be refused
entry. FSIS has concluded that requiring HACCP systems in combination
with the two-stage inspection approach will better ensure the safety of
imported meat and poultry products.
All countries exporting raw products to the U.S. must develop and
implement performance standards that are equivalent to the pathogen
reduction performance standards for Salmonella. They must also be able
to demonstrate that they have systems in place to assure
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compliance with the standards. As with any other type of standard, FSIS
could choose to test imported product for Salmonella at port-of-entry
to verify the effectiveness of the foreign inspection system.
With respect to the specific requirements for sampling generic E.
coli to validate control of slaughter and sanitary dressing procedures,
it will be necessary for all foreign countries to demonstrate that they
have an equivalent procedure to verify that they are controlling their
slaughter and sanitary dressing processes.
There were several comments related to trade issues. Most of the
comments concerning the impact on exports dealt with the proposed
requirement for antimicrobial treatment of U.S. product. That proposed
requirement raised particular concerns because the European Union
member states and Canada restrict the use of certain antimicrobials on
meat and poultry carcasses. The concerns raised in the comments are no
longer an issue because the final rule does not require the use of
antimicrobials. The final rule will affect exports only if a company
has difficulty meeting the microbial performance criteria without using
an antimicrobial. One option discussed in the proposed rule was that
hot water would be considered to be an acceptable antimicrobial
treatment, and that would be acceptable to Canada and the members of
the European Union. The public comments also indicated that Trisodium
Phosphate (TSP) is approved for use in Canada and the United Kingdom
and is being considered by the European Union, Australia, and New
Zealand.
Comments related to imports were concerned about the procedures
FSIS would use to determine equivalence with the new U.S. requirements.
As a condition of the NAFTA Treaty and the GATT Treaty, the United
States has agreed to allow imports from countries that have systems of
inspection equivalent to that of the United States. FSIS is considering
alternative methods for determining that a foreign country's system of
inspection can assure that the establishments within that system are
using a process control system equivalent to the HACCP-based inspection
system outlined in the final rule.
F. Impact on Agency Costs
Implementation of this rule will lead to both one-time nonrecurring
costs and recurring costs for FSIS. There are three categories of one-
time nonrecurring costs: (1) Training, (2) in-establishment
demonstration projects, and (3) laboratory renovation. In order to
implement the rule, FSIS will provide training to in-establishment
personnel in two segments. The first training segment will cover issues
related to sanitation standard operating procedures and generic E. coli
sampling and testing requirements. The estimated costs for this
activity is $3.6 million in the first year of implementation. The
second training segment will cover issues related to the implementation
of HACCP and is estimated the cost $3.6 million spread over the second
and third year of implementation. FSIS will utilize the train-the-
trainer approach to minimize the costs of these initiatives. FSIS is
also committed to working with States and industry to sponsor HACCP
demonstration projects for small businesses. Pursuant to implementation
of the HACCP rule, microbiological sampling and testing will increase
dramatically. In the period from 1990 to 1995, FSIS averaged
approximately 33,000 analyses for microbiology per year. This is
estimated to increase to 125,000 analyses per year after HACCP
implementation. In order to accommodate this increase, FSIS will
renovate its field laboratory facilities to expand their capacity,
improve ability to test for a broader range of pathogens, and purchase
new equipment. FSIS estimates that the planned renovation will cost
$1.5 million.
By implementing this rule, FSIS will incur recurring costs
associated with increased microbiological testing and upgraded
inspector salaries. FSIS estimates that microtesting costs will
increase approximately $3.0 million annually. Of this amount $2.0
million is needed for equipment, supplies, and shipping costs to
conduct Salmonella testing, $0.5 million for microtesting conducted to
verify HACCP systems, and $0.5 million for personnel necessary to
handle the increased workload. Under HACCP-based inspection, FSIS
personnel will be required to assume greater responsbility for more
complex food inspection tasks. Slaughter inspectors will be required to
perform health and safety tasks, such as taking microbiological
samples, and verifying HACCP systems. Processing inspectors' roles will
take them out of the establishment and put them into retail and market
place settings to take microbiological samples, and to ensure meat and
poultry products are handled in a manner to that minimizes the growth
of pathogenic organisms. FSIS estimates that compensating inspectors
for assuming more complex food safety tasks will cost $1.6 million per
year.
G. Impact on State Programs
Comments stated that FSIS failed to adequately consider the cost of
the changes to State programs and that FSIS was increasing the resource
demands for State programs without providing adequate funding. The
preliminary analysis did not address the impact on State programs.
However, FSIS recognizes that the 26 States operating their own meat
and poultry inspection programs will likely have to substantially
modify their programs after the HACCP/Pathogen Reduction regulation is
finalized to remain ``at least equal to'' Federal inspection programs
as required by the FMIA and PPIA. During the regulation's
implementation period, FSIS will be using the Agency's State-Federal
Program staff to assist the States in bringing the necessary changes to
the State inspection programs. Although FSIS has requested some
additional funds to implement this rule, FSIS has also acknowledged
that implementation of this rule will require eliminating some tasks,
conducting other tasks differently and streamlining the organization in
order to free up resources to fully address the new requirements. FSIS
believes that the same type of restructuring or reprogramming will take
place within the State programs. This does guarantee, however, that all
States with inspection programs will be able to implement the necessary
program changes without additional funds. FSIS believes, however, that
with FSIS assistance and with the flexibility provided under the
``equal to'' provisions, most of the States should be able to modify
their programs with minimal additional funding. To the extent that
there are any additional costs, the State inspection programs are
eligible to receive up to 50 percent Federal matching funds.
H. Consumer Welfare Analysis
It is likely that at least some of the costs of the new HACCP-based
regulatory program will be passed on to consumers in the form of higher
prices. Even if costs are fully reflected in retail prices, the impact
on consumers and consumption will be small. Retail costs are not
expected to increase more than 0.02 percent. Retail demand for meat and
poultry is inelastic. A likely range is -0.25 to -0.75. This suggests
changes in quantity demanded of less than 0.02 percent. Given that
annual per capita meat and poultry consumption is about 211 pounds,
retail weight, the impact on individual consumption will be less than
\1/10\th of a pound per year. In aggregate, with a high impact
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scenario, consumption would decrease by about 50 million pounds. These
impacts may be overstated if meat and poultry producers pass some costs
back to livestock and poultry producers. Improved consumer confidence
in the safety of meat and poultry could offset price driven decreases
in consumption.
IV. Analysis of Public Health Benefits
A. Introduction
This section addresses the methodology used to develop the
estimates for public health benefits that, for the purpose of this
final Regulatory Impact Assessment, have been defined as the reduction
in the cost of foodborne illness attributable to pathogens that
contaminate meat and poultry products at the manufacturing stage. This
section is organized around the Agency's responses to the public
comments related to benefits. The first part of this section addresses
the general comments related to risk assessment. The Agency has
responded to these general requirements by providing an overall summary
of the current state-of-the-art with respect to risk assessment for
foodborne pathogens. The second part of the discussion (see subsection
titled ``Analysis of Comments on Public Health Benefits'') addresses
the more specific comments on the methodology used to estimate benefits
in the preliminary analysis.
Several comments suggested that FSIS has not conducted an adequate
risk assessment and/or should conduct a thorough risk assessment before
proceeding with the current rulemaking. More focused comments assert
that the relationship between pathogen reduction at the manufacturing
stage and foodborne illness reduction is unknown. Those comments
suggest that establishing that relationship requires a quantitative
risk assessment, i.e., an estimate of the probability of adverse health
effects (foodborne illness) given a particular level of a hazard
(pathogens at manufacturing stage).
The preliminary analysis and this final RIA recognize that the
relationship is unknown and acknowledge that there are significant data
gaps regarding both likelihood and magnitude of illness and numbers of
foodborne pathogens. These data gaps mean that multiple assumptions
must be made in order to calculate the probabilities of risk, and FSIS
is concerned with this tremendous uncertainty. However, the agency is
developing quantitative assessments and believes that these will become
the basis on which to make future regulatory decisions. In this
rulemaking, FSIS estimates of the risk of foodborne disease linked to
specific pathogens are based upon the best judgement of nationally
recognized experts in infectious disease, epidemiology, microbiology,
and veterinary medicine. FSIS is also relying on a qualitative
estimation of risk as expressed in publications and summary reports
from the CDC, other public health agencies, and special panels, such as
the National Advisory Committee on Microbiological Criteria in Foods
and those established by the NAS. Based on this sizable body of
information and scientific judgement, FSIS is proceeding to develop
benefit estimates using the assumption that a reduction in pathogens
leads to a proportionate reduction in illness and death. The benefits
analysis could have used a more conservative relationship estimate,
e.g., a reduction in pathogens leads to a reduction in illness that is
less than proportional. However, given the current level of knowledge,
FSIS views the proportional assumption as most appropriate at present.
The Department has initiatives in place that will begin to relate
pathogen levels at inspected establishments to incidence of human
illness and support quantitative risk assessment (see Section IV-D on
FSIS Data Initiatives). The present paucity of data to support a risk
model for the major foodborne pathogens causing human disease limits
the usefulness of quantitative risk assessment in the regulatory arena
of meat and poultry inspection. It is unlikely that any single
numerical constant will adequately describe the dose-response
relationships for all pathogens associated with all of the products
that FSIS regulates, given the complexity of possible interactions of
factors associated with the host, the pathogenic strain, the diet, and
the environment (CAST, 1994).
The Federal Crop Insurance Reform and Department of Agriculture
Reorganization Act of 1994 (P.L. 103-354) now requires that for each
proposed major regulation (i.e. economic effects of at least $100
million a year and effects on human health, safety, or the environment)
the Department publish an analysis of the risks addressed by the
regulation. While this statute does not apply to this final rule, FSIS
is providing a qualitative estimation of risk (Tables 4 and 5) and a
recommendation to manage risk using HACCP in meat and poultry
inspection programs. Concurrently, scientists from FSIS and USDA's
Agricultural Research Service (ARS), Economic Research Service (ERS),
and modelers from academia and industry continue to develop risk models
which blend failure analysis, predictive microbiology, and other models
into the framework described by the NAS (NRC, 1983). FSIS believes this
approach is flexible and responsive to new data necessary to fully
document risks of foodborne diseases.
B. FSIS Risk Assessment
Following the publication of the 1985 National Academy of Sciences
(NAS) study on the scientific basis for meat and poultry inspection,
FSIS requested that the National Research Council of NAS conduct a
follow-up study that included the objective of developing a risk
assessment model for the poultry production system. The subsequent
report, ``Poultry Inspection: The Basis for a Risk-Assessment
Approach'' was published by the National Academy Press in 1987. The
1987 study concluded that the present system of inspection provides
little opportunity to detect or control the most significant health
risks presented by microbial agents that are pathogenic to humans. The
study also concluded that current databases can serve as the basis for
a comprehensive, quantitative risk assessment only for certain well-
characterized chemical residues.
The committee conducting the study also concluded that their report
did constitute a qualitative risk assessment that could be useful for
many purposes, including the evaluation of inspection strategies. That
assessment found: ``There is evidence linking disease in humans to the
presence of pathogens on chickens. For example, epidemiological studies
indicate that approximately 48% of Campylobacter infections are
attributable to chicken. Data also suggest that chicken is probably an
important source of salmonellosis in the United States.'' Based on
these and other findings, the committee recommended that FSIS ``modify
the existing system so that it more directly addresses public health
concerns.'' FSIS believes that the implementation of HACCP programs at
slaughter for meat and poultry is such a ``modification'' of the food
safety system which will address human health hazards, particularly
foodborne diseases.
C. Risk Assessment Framework
The National Research Council (1983) presented a framework for risk
assessment that has become a standard paradigm to organize risk
assessments for chemical and microbial hazards. The framework,
consisting of hazard identification, dose-response assessment, exposure
assessment, and risk characterization, is flexible and can accommodate
many different modeling strategies. The major distinction
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between foodborne microbial risk assessments and chemical risk
assessments may be the additional uncertainties of microbial growth and
survival in food prior to consumption. Survival of pathogens present in
a raw food and after cooking can be modeled using predictive
microbiology methods. These models can also address the growth of
pathogens with time and temperature abuse of raw and cooked foods.
One of the first U.S. publications on the application of predictive
microbiology to microbial risk assessment (Buchanan & Whiting, 1996)
included estimations of risk of salmonellosis for several ``what-if
scenarios'' as examples of potential time and temperature abuses of
partially cooked food. The predictive microbiology model was linked to
a published dose-response model for salmonellosis (Haas, 1983) to
calculate a risk estimate. The dose-response model was developed by
empirically fitting data from human feeding studies conducted at high-
dose challenges with a number of pathogenic strains of Salmonella to
the ``beta poisson'' model (Haas, 1983). The authors generated risk
estimates for selected cooking and abuse scenarios, but recognized that
the risk of illness is zero when the pathogen is not present in the
sample even with unsafe food handling. HACCP programs at slaughter are
expected to affect pathogen presence and levels before potential time
and temperature abuses can occur. Therefore, changes at slaughter, in
the duration of cooking, and final storage conditions of the food exert
a tremendous impact upon the model outcomes.
An unpublished draft risk model is in development as a research
endeavor by Agriculture and Agri-Food Canada and Health Canada. A
variety of modeling approaches were organized within the 1983 NRC
framework to estimate risk of human illness from E. coli 0157:H7 in
ground beef. The draft risk model includes many stochastic variables to
account for the variability and uncertainty associated with the inputs
and assumptions of the model. The authors are developing the model to
identify current limitations to the construction of quantitative models
which accurately describe the risk of foodborne disease along the farm
to fork continuum.
These recent quantitative risk assessment efforts are an
encouraging beginning and serve to illustrate the tremendous
uncertainties created by insufficient data describing processes
throughout the farm to table continuum that contribute to risk.
Additional uncertainties surround assumptions based on epidemiologic
data for human illness. For example, recent data in the U.S. indicates
a growing number of outbreaks of E. coli 0157:H7 disease linked to
sources other than ground beef. The ecology of the organism on the
farm, in the bovine gastrointestinal tract, and in irrigation,
recreational, and drinking waters is largely unknown. Additionally, the
primary sources of E. coli 0157:H7 causing sporadic disease may remain
undercooked hamburger and may differ from vehicles causing outbreaks,
as has been documented for Campylobacter (CDC, 1988). Outbreaks of
campylobacteriosis have been caused primarily by unpasteurized milk and
contaminated water, yet the overwhelming majority of infections are
sporadic and have been linked to undercooked chicken. Control
strategies to reduce both outbreak and sporadic case numbers for both
of these pathogens may require greater understanding of vehicles of
disease and more information than is currently available.
FSIS concludes that risk models for foodborne illnesses are
necessarily based largely on assumptions because scientific data
describing key foodborne disease processes have not been developed. The
models are extremely useful to identify basic research needs that might
reduce the uncertainty associated with the inputs and assumptions of
the models. The agency is proposing initiatives to generate data which
may reduce uncertainties associated with modeling the risk of foodborne
diseases. However, application of microbial risk assessment models to
regulatory decision-making appears premature at this time. The
following is a summary of the availability and limitations of data
supporting risk assessment for foodborne pathogens:
1. Hazard Identification
The Agency selected from the pathogens listed in Tables 4 and 5 the
three most common enteric pathogens of animal origin: Campylobacter
jejuni/coli, E. coli 0157:H7, Salmonella and one environmental pathogen
Listeria monocytogenes for consideration in risk assessment. FSIS
believes that these four pathogens may contaminate meat and poultry
food vehicles at slaughter and can be reduced through improved process
control in the manufacturing sector. Available data on estimated human
disease incidence are summarized in Table 4. Data on human disease
attributable to proven as well as epidemiologically linked pathogens
and food vehicles are presented in Table 5. Additional and more precise
information for this section regarding estimated national disease
incidence and disease severity and duration is expected on these
pathogens from the sentinel site surveillance initiative.
2. Exposure Assessment
Rarely can actual exposure to a specific strain of foodborne
pathogen be quantified with certainty in foodborne disease outbreaks.
Microbes in food are known to be non-homogeneously distributed,
imposing additional uncertainty due to sampling error upon the
analytical variability of the methods for detection and quantification
of microbes in foods. The outbreak strain may or may not be detected in
the feces of diarrheal cases or in leftovers or companion samples from
suspected lots. The levels detected in leftovers or companion samples
from the same lot of food may or may not be representative of the
serving that was prepared and consumed since the microbial numbers vary
with time and temperature conditions and the initial microbial
populations. The amount of the serving consumed may not be known.
The FSIS baseline studies provide data on occurrence of pathogens
(likelihood) and levels (magnitude) in uncooked meat and poultry
products at slaughter and raw ground processing. Data for likelihood
and magnitude of pathogens in the distribution, preparation, and
consumption phases of the farm-to-fork continuum of food production are
sparse. Predictive microbiology models may be the most cost-effective
method to deduce possible exposure scenarios in meat and poultry beyond
the slaughter phase that may result in foodborne illness. The
likelihood that the selected scenarios of improper cooking and abuse
actually occur among U.S. consumers may not be measurable, but the
scenarios may be useful in modification of behaviors that pose
increased risk to consumers.
3. Dose-Response Assessment
The relationship between the dose of a pathogen and response in the
host, when known, can vary greatly for foodborne pathogens. Human
feeding studies with foodborne pathogens were largely conducted several
decades ago with small numbers of healthy adult males. One study
reported both ill and asymptomatic volunteers who had consumed up to
1,000,000,000 pathogenic Salmonella. Outbreak data for other Salmonella
serotypes in food vehicles suggest a range of infective doses from one
cell to 1,000,000,000,000 cells (Blaser & Newman, 1982). Fatty food
vehicles, including some meat and
[[Page 38961]]
poultry products, are thought to protect enteropathogens from stomach
acids and digestive enzymes that might otherwise reduce the dose to the
intestinal tract and reduce the likelihood of disease. The effects of
competition of the pathogen with the large indigenous microbial
populations in food (ICMSF, 1980) and in the human gastrointestinal
tract (Rolfe, 1991) may reduce the likelihood and/or the severity of
foodborne disease.
Even carefully controlled volunteer feeding experiments at doses up
to one billion organisms per volunteer have shown variability in the
infectious dose of one pathogen for individuals within a group of
seemingly healthy, young adults. Extrapolation of empirical models of
effects at high doses to low doses typical of properly handled food may
or may not be appropriate. The dose-response curve for healthy adult
males may not be useful in estimating dose-response relationships for
the general population or sensitive sub-populations. The data available
from human feeding studies were generated from very few species and
strains of bacterial pathogens, excluding E. coli 0157:H7. Dose-
response modeling is crucial to microbial and chemical risk
assessments. FSIS believes that application of dose-response models in
food safety regulation requires careful examination of the validity of
the assumptions and inputs of the model and of the plausibility of the
model as a descriptor of foodborne disease processes.
4. Risk Characterization
The integration of exposure and dose-response models is expected in
risk characterization, along with sensitivity and uncertainty analyses
(Burmaster & Anderson, 1995) for the risk model. Perhaps of greater
significance than the numerical estimate of risk is the uncertainty
associated with the estimate. A fully developed risk characterization
would include risk estimates and sensitivity/uncertainty analyses for
alternative models and assumptions. FSIS is collaborating with
scientists in academia, the Agricultural Research Service, the Animal &
Plant Health Inspection Service, the Economic Research Service, and the
Office of Risk Assessment and Cost Benefit Analysis to develop and
validate a risk assessment model for a single pathogen in a single meat
product. This model may be modified for other specific pathogens of
concern. The expectation of a generic model for all foodborne disease
agents in all products does not appear promising based on differences
in pathogenesis of bacterial species and strains and in human
sensitivity and pathology.
FSIS continues to evaluate new information on foodborne pathogens
and on risk assessment methods and tools in accordance with the FSIS
public health mission. The NAS Report, the CAST Report and the 1995
Conference recognize HACCP as a system to reduce the likelihood of
foodborne illness. The CAST Task Force also concluded that ``the
efficacy of a HACCP system depends on the rigor and consistency with
which it is designed and implemented and the use of (a) critical
control point(s) that will control pathogens.''
D. FSIS Data Initiatives
The 1994 report, ``Foodborne Pathogens: Risks and Consequences,
CAST Task Force Report No. 122, September 1994'' concluded that ``a
comprehensive system of assessing the risks of human illness from
microbial pathogens in the food supply has yet to be devised.'' They
cited the limitations of the current food safety information database
and the difficulty in accumulating dose response and minimum infective
dose data. A recent multidisciplinary conference, ``Tracking Foodborne
Pathogens from Farm-to-Table, Data Needs to Evaluate Control Options'',
carefully reviewed current databases and confirmed limitations outlined
in the CAST Task Force report.
FSIS has established initiatives to improve the quality and
quantity of data in two major areas. First, FSIS is working with the
Food and Drug Administration (FDA) and the Centers for Disease Control
and Prevention (CDC) to establish an active sentinel site surveillance
system for the major causes of foodborne illness. This project is
designed to accumulate data on the incidence of foodborne illness by
pathogen and by food.
Second, the Agency has been developing baseline data for pathogen
levels on major food animal species at the time of slaughter. The
baseline data will allow the Agency to detect changes in the overall
nation-wide pathogen levels. The National Baseline program was
initiated in 1992 to provide information on the type and level of
microbiological contamination on raw products under Federal inspection.
Each sample collected is analyzed for nine microorganisms or groups of
organisms. Microbiological baseline data are now available for steers
and heifers, cows and bulls, and broiler chickens.
If sufficient data on both pathogen levels and foodborne disease
epidemiology result from current and future initiatives, FSIS should be
able to develop models showing how these two variables are related for
different pathogens. These models should then permit/facilitate a
quantitative estimate of risk. Such data are essential for FSIS to
evaluate the effect of control measures on both pathogens levels and on
foodborne illness.
E. ARS Food Safety Research Program
The Agricultural Research Service (ARS) administers a food safety
research program that is currently funded at approximately $45 million
per year. This program addresses problems in four different areas;
pathogen reduction, mycotoxins, residues, and natural toxins. The
reduction of microbial pathogens in food products of animal origin is
the most pressing food safety problem today. Consequently, the pathogen
reduction component is the largest of the four areas and is currently
funded at $18.2 million annually. The ARS research in pathogen
reduction addresses both preharvest and animal production, and post
harvest problem areas, with approximately equal funding for each.
Ongoing ARS research will help FSIS improve its capability for
performing quantitative risk assessment in the area of foodborne
pathogens or improve the ability to predict the effectiveness of new
pathogen reduction technologies. Ongoing projects include the modeling
of bacterial growth or thermal death times which will help set
standards for meat and poultry products. Ongoing projects will also
provide new laboratory screening or confirmatory methods. Other
projects provide and/or evaluate technology and management methods
which can help producers achieve lower contamination levels in animals
presented for slaughter, such as vaccines or competitive bacterial
cultures to prevent pathogens in live animals. There are also
technology and management methods for use in slaughter and processing
establishments, such as, organic acids for use in carcass sanitation,
improvements to the feather picking operation for poultry, washing of
trailers to reduce microbiological contamination, and establishment of
guidelines on the microbiological safety of recycling cooling solutions
for ready-to-cook meat and poultry products. In many cases the research
may provide the scientific basis for developing and improving
technology, for example, the nature of bacterial attachment to various
meat surfaces.
FSIS can and does forward very specific research requests to ARS.
In preparation for this final rule, FSIS requested that ARS compare the
results
[[Page 38962]]
from different microbial sample collection techniques, sponging versus
excision at one versus three carcass sites. These studies are currently
being conducted on both cow/bull and market hog carcasses. There are
other specific ARS projects that will help provide the scientific basis
for HACCP through risk assessment, predictive microbiology, and
pathogen reduction interventions for several different bacterial
pathogens which must be controlled to assure the safety of meat and
poultry.
These projects include: (1) Development of models to predict the
growth rates, survival times, and thermal death rates for microbial
pathogens potentially present in foods, including meat and meat
products. (Microbiological modeling is time consuming and expensive
because it requires that the data be quantified, that is, that numbers
of bacteria are obtained, rather just the knowledge of the presence or
absence of a pathogen under the conditions of the test.) The
microorganisms being studied include E. coli O157:H7, Listeria
monocytogenes, and Salmonella. These models are written into personal
computer software that gives FSIS a readily useable tool to help
evaluate proposed meat processes and assess out-of-process events.
Refining predictive models has the goal of linking an entire process
from raw ingredients to distribution of finished product. A specific
project is to model the survival of E. coli O157:H7 during the
manufacture of uncooked, fermented meat products. Using the information
obtained, ARS will closely collaborate with other USDA agencies to
develop strategies for risk reduction using the various processing
techniques, and to create risk assessment models.
(2) Modeling studies to predict the thermal inactivation of spore-
forming and non-spore-forming bacterial pathogens of both cooked and
ready-to-eat products. These studies will be extended to the cooling of
these products to ensure that there is no potential for growth of
Clostridium botulinum and C. perfringens.
(3) Determination of the long-term effects (21 days of storage at
refrigerated temperatures) of organic acid treatment of red meat on
some key pathogens (E. coli O157:H7, Listeria, and Clostridium), as
well as on spoilage bacteria (mesophilic aerobes, lactic acid bacteria,
and pseudomonads).
(4) Delineation of the parameters affecting the antibacterial
activity of organic acids. These include tissue type (pre-rigor, post-
rigor, frozen post rigor), inoculum type (pure culture or inoculated
feces), inoculum level and the temperature of spray wash at meat
surface. These results should clarify inconsistent reports on
antibacterial activity of organic acids and also define optimum
conditions to maximize the antibacterial activity of organic acids.
(5) The correlation of the Campylobacter levels in broilers from
the chill tank with their Campylobacter levels during production.
F. Analysis of Comments on Public Health Benefits
There were many comments on the methodology used to estimate public
health benefits in the preliminary analysis. This methodology used a
series of estimates or assumptions based on incomplete data related to
the six following areas:
<bullet> Incidence of foodborne illness
<bullet> Cost of foodborne illness
<bullet> Percentage of foodborne illness and cost of foodborne
illness attributable to meat and poultry products
<bullet> Pathogens addressed by the rule
<bullet> Effectiveness of rule in reducing pathogens
<bullet> Estimated reduction in cost of foodborne illness related
to reduction of pathogens
To facilitate discussion of the issues raised in comments, the
issues are addressed organized by these six areas.
1. Incidence of Foodborne Illness
Table 4 presents the most recent estimates on the incidence of
illness and death for selected pathogens along with the latest
estimates on the percentage of illness and death which is foodborne. As
discussed in the preliminary RIA, Table 4 includes the ``best
estimates'' when precise data are not available. Many of these
estimates are based on the landmark CDC study by Bennett, Holmberg,
Rogers, and Solomon, published in 1987, which used CDC surveillance and
outbreak data, published reports, and expert opinion to estimate the
overall incidence and case- fatality ratio for all infectious and
parasitic diseases. Estimates on the foodborne percentage of illness
and death for bacteria in Table 4 are all based on CDC data. The
resulting estimates for the number of foodborne cases and deaths are
presented in the second and third columns of Table 5.
The benefits for the preliminary analysis and this final RIA are
calculated for the three most common enteric pathogens of animal
origin: Campylobacter jejuni/coli, E. coli O157:H7, Salmonella and one
environmental pathogen Listeria monocytogenes. FSIS believes that these
four pathogens can be reduced through improved process control in the
manufacturing sector.
Although Clostridium perfringens and Staphylococcus aureus also
cause a significant number of foodborne illnesses, they are not
included in the benefits analysis because it is not clear that the
HACCP-based regulatory program, which focuses on federally inspected
processing, will significantly affect the incidence of disease caused
by these organisms. Staphylococcus aureus usually enters the food chain
through food handlers in restaurants and other commercial kitchens.
Although C. perfringens may enter the food chain through the slaughter
process, it is so ubiquitous in the environment that FSIS will not
assume that controls at slaughter will be effective against this
pathogen.
One commenter questioned why the Agency has not addressed the
public health problem of toxoplasmosis given the Table 5 estimate of
$2.7 billion in annual costs. FSIS believes that while process control
may help decrease the spread of cysts during boning and cutting
operations, most of the Toxoplasma gondi cysts are internal to
infective muscle tissues and are not addressable by process control.
Therefore, FSIS is making the more conservative assumption to exclude
this pathogen in the benefits estimate of disease averted.
Many comments suggested that the large range in the illness
incidence estimates demonstrates that there are insufficient data on
which to base a new regulatory program. Historically, the lack of
quantitative data on benefits and specific health risks have meant that
health and safety regulations have required decisionmaking under
uncertainty and have required the decisionmaker to balance the need to
act with the need for additional or improved data. Compared to such
issues as whether a chemical is a potential human carcinogen or whether
low levels of air pollutants cause adverse health effects, the health
effects of enteric pathogens are relatively well documented. If the
pathogens enter the food supply, they do, under certain conditions,
cause foodborne illness. If their presence can be prevented, no amount
of temperature abuse, mishandling or undercooking can lead to foodborne
illness.
The Agency believes that the existing estimates on foodborne
illness are adequate to conclude that a substantial and intolerable
public health problem exists. Furthermore, existing estimates are
appropriate for developing estimates on the cost of foodborne illness
attributable to meat and poultry. The
[[Page 38963]]
Agency notes that similar estimates on the incidence of foodborne
illness have been published by scientists from ERS in peer-reviewed
journal articles (see footnotes to Table 5) and by the 1994 CAST Task
Force.
The above statement that Table 4 includes the most recent estimates
of the incidence of illness and death requires further explanation in
the case of Listeria monocytogenes. The estimates of 1,795-1,860 cases
of listeriosis and 445-510 deaths are the ones used in the latest cost
of illness study conducted by ERS. ERS is in the process of publishing
a comprehensive documentation for the estimates of cost of illness for
1993. In their draft document they acknowledge that the estimate for
listeriosis cases originates from an extrapolation to the U.S.
population of incidence data from a CDC-conducted surveillance study of
six geographic regions in 1986 and 1987 (Gellin et al. 1987). They also
note that (Tappero et al. 1995) found that the incidence of listeriosis
has decreased since the 1960's and that projections from the
surveillance data suggest that there were 1,092 listeriosis cases and
248 deaths in 1993. ERS did not modify their cost of illness estimates
because Tappero et al., was published after their analysis was
concluded.
FSIS considered modifying the cost of illness estimates for this
final analysis but decided to use the estimates in Tables 4 and 5
because (1) They are the figures that will appear in the upcoming ERS
publication and, (2) updating the listeriosis estimates would have
minimal impact on the overall cost of illness estimates. Considering
the overall range and uncertainties involved in the cost of illness
estimates, the change in listeriosis estimates has negligible impact on
the regulatory analysis information conveyed through the potential
benefits estimate.
The Agency also recognizes that in using the 1993 estimates for
incidence of foodborne illness, the benefits analysis has not accounted
for possible reductions in foodborne illness attributable to the rule
that mandated safe handling statements on labeling of raw meat and
poultry products. The rule mandating safe handling instructions became
effective on May 27, 1994. Thus, it can be argued that the incidence of
foodborne illness for 1994 through the present should reflect the
effectiveness of the 1994 labeling requirement in reducing the
incidence of illness.
FSIS is not aware of any quantitative evaluation of the
effectiveness of safe handling labeling. Two recent surveys indicate a
high level of awareness, but these surveys do not contain findings that
can be translated into changes in consumer behavior. A recent
Associated Press poll found that 9 in 10 Americans say they follow the
safe-handling instructions. This poll, conducted in April 1996,
included 1,019 randomly selected adults. This was a telephone survey
conducted by ICR Survey Research Group. A November 1995 survey
conducted by Wegman Food Markets in Buffalo, Rochester, and Syracuse
found that 67.9 percent of respondents indicated they had read the safe
handling information. The Wegman's survey found that most household
meat preparers rely on color of meat or clarity of juices rather than
temperature to determine when meat has been cooked thoroughly.
In this analysis, FSIS has not attempted to adjust the 1993
baseline to account for safe handling labeling. The potential effect of
the 1994 regulation is one of many factors that could be affecting the
current incidence or cost of illness. A May 1996 GAO study on foodborne
illness notes that food safety and public health officials believe that
the risk of foodborne illness is increasing. If they are correct, the
1994 labeling rule may be slowing the growth rather than reducing the
absolute level.
There are many other factors that could have been incorporated into
the baseline for the analysis such as population growth and increases
in the cost of medical care. FSIS believes that attempts to adjust the
cost of illness baseline to account for factors such as inflation,
possible increases in foodborne illness due to behavior change or
population increases, and possible decreases due to inventions such as
safe handling labels are more likely to be misleading than informative
given the level of uncertainly and wide range in existing estimates.
2. Cost of Foodborne Illness
The fourth column of Table 5 shows that the 1993 estimated cost of
foodborne illness by pathogen or parasite was between $5.6 and $9.4
billion. These cost of illness estimates have been developed by ERS in
conjunction with CDC over the past 15 years. As indicated in footnotes
to Table 5, the results of that work have been frequently published in
peer-reviewed journals.
There were only a few public comments on the proposed rule which
addressed the methodology used for estimating the cost of foodborne
illness. Some comments argued that the public health benefit estimates
are low because of the low value-of-life factor used in the estimates
for the cost of foodborne illness.
ERS intentionally used a conservative method to estimate the value
of a statistical life (VOSL) acknowledging the controversy over valuing
lives. ERS used Landefeld and Seskin's VOSL estimates and recognizes
that the cost of illness estimates would be substantially higher if
they used alternative methods. For example, Viscusi (1993) summarized
the results of 24 principal labor market studies and found that the
majority of the VOSL estimates lie between $3 million and $7 million
per life. A survey of the wage-risk premium literature on the
willingness to pay to prevent death concluded that reasonably
consistent estimates of the value of a statistical life range from $1.6
million to $6.5 million dollars (1986 dollars) (Fisher et al. 1989).
Updated to 1993 dollars using the change in average weekly earnings,
Viscusi's range becomes $3.2 million to $7.6 million per VOSL and
Fisher's range becomes $2.0 million to $10.4 million dollars for each
statistical-life lost. Viscusi and the Fisher estimates are greater
than the highest Landefeld-Seskin (LS) VOSL estimate of $1,584,605 in
1993 dollars (estimate for a 22 year old).
Table 4.--Sources of Data for Selected Pathogens, 1993
--------------------------------------------------------------------------------------------------------------------------------------------------------
Estimated
Pathogen Estimated number of number of Source(s) for case and death Percent Source
cases deaths estimates foodborne
--------------------------------------------------------------------------------------------------------------------------------------------------------
Bacteria:
Campylobacter jejuni or coli.. 2,500,000 200-730 Tauxe............................... 55-70 Tauxe et al.
Clostridium perfringens....... 10,000 100 Bennett et al....................... 100 Bennett et al.
Escherichia coli O157:H7...... 10,000-20,000 200-500 AGA Conference...................... 80 AGA Conf./CDC.
Listeria monocytogenes........ 1,795-1,860 445-510 Roberts and Pinner.................. 85-95 Schuchat.
[[Page 38964]]
Salmonella.................... 800,000-4,000,000 800-4,000 Helmick et al./Bennett et al. 87-96 Bennett et al./Tauxe & Blake.
Staphylococcus aureus......... 8,900,000 7,120 Bennett et al....................... 17 Bennett et al
Parasite:
Toxoplasma gondii............. 4,111 82 Roberts et al....................... 50 Roberts et al.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sources: American Gastroenterological Association Consensus Conference on E. coli O157:H7, Washington, DC, July 11-13, 1994. Bennett, J.V., S.D.
Holmberg, M.F. Rogers, and S.L. Solomon. 1987. ``Infectious and Parasitic Diseases,'' In R.W. Amler and H.B. Dull (Eds.) Closing the Gap: The Burden
of Unnecessary Illness. Oxford University Press, New York. Helmick, C.G., P.M. Griffin, D.G. Addiss, R.V. Tauxe, and D.D. Juranek. 1994. ``Infectious
Diarrheas.'' In: Everheart, JE, ed. Digestive Diseases in the United States: Epidemiology and Impact. USDHHS, NIH, NIDDKD, NIH Pub. No. 94-1447, pp.
85-123, Wash, DC: USGPO.
Roberts, T., K.D. Murrell, and S. Marks. 1994. ``Economic Losses Caused by Foodborne Parasitic Diseases,'' Parasitology Today. vol. 10, no. 11: 419-423.
Schuchat, Anne, CDC, personal communication with T. Roberts at the FDA Science Forum on Regulatory Sciences, Washington, DC, September 29, 1994.
Tauxe, R.V., ``Epidemiology of Campylobacter jejuni infections in the United States and other Industrialized Nations.'' In Nachamkin, Blaser, Tompkins,
ed. Campylobacter jejuni: Current Status and Future Trends, 1994, chapter 2, pages 9-19. Tauxe, R.V. and P.A. Blake, 1992. ``Salmonellosis'' Chap. 12.
In: Public Health & Preventative Medicine, 13th ed. (Eds: Last JM: Wallace RB; Barrett-Conner E) Appleton & Lange, Norwalk, Connecticut, 266-268.
Tauxe, R.V., N. Hargrett-Bean, C.M. Patton, and I.K. Wachsmuth. 1988. ``Campylobacter Isolates in the United States, 1982-1986,'' Morbidity and
Mortality Weekly Report, vol 31, no. SS-2: pages 1-14.
Table 5.--Medical Costs and Productivity Losses Estimated for Selected Foodborne Pathogens, 1993
--------------------------------------------------------------------------------------------------------------------------------------------------------
Foodborne illness Percent Meat/poultry related Total
------------------------------ Foodborne from ------------------------------ costs *
Pathogen * costs meat/ meat/
Est. No. of Est. No. (bil $) poultry Est. No. of Est. No. poultry
cases deaths (%) cases deaths (bil $)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Bacteria:
Campylobacter jejuni or coli............................. 1,375,000-1,75
0,000 110-511 0.6-1.0 75 1,031,250-1,31
2,500 83-383 0.5-0.8
Clostridium perfringens **............................... 10,000 100 0.1 50 5,000 50 0.1
Escherichia coli 0157:H7................................. 8,000-16,000 160-400 0.2-0.6 75 6,000-12,000 120-300 0.2-0.5
Listeria monocytogenes................................... 1,526-1,767 378-485 0.2-0.3 50 763-884 189-243 0.1-0.2
Salmonella............................................... 696,000-3,840,
000 696-3,840 0.6-3.5 50-75 348,000-2,880,
000 348-2,880 0.3-2.6
Staphylococcus aureus **................................. 1,513,000 1,210 1.2 50 756,500 605 0.6
------------------------------------------------------------------------------------------
Subtotal............................................. 3,603,526-7,13
0,767 2,654-6,546 2.9-6.7 N/A 2,147,513-4,96
6,884 1,395-4,461 1.8-4.8
------------------------------------------------------------------------------------------
Parasite:
Toxoplasma gondii........................................ 2,056 41 2.7 100 2,056 41 2.7
------------------------------------------------------------------------------------------
Total................................................ 3,605,582-7,13
2,823 2,695-6,587 5.6-9.4 N/A 2,149,569-4,96
8,940 1,436-4,502 4.5-7.5
--------------------------------------------------------------------------------------------------------------------------------------------------------
Source: ERS, 1993
* Column rounded to one decimal place.
** Roberts' rough approximation of costs in ``Human Illness Costs of Foodborne Bacteria'', Amer. J. of Agricultural Economics, vol. 71, no. 2 (May 1989)
pp. 468-474 were updated to 1993 dollars using the Consumer Price Index (all items, annual average). Cost estimates for other pathogens are more
detailed, see the following for a discussion of the methodology:
listeriosis--Roberts, Tanya and Robert Pinner, ``Economic Impact of Disease Caused by Listeria monocytogenes'' in Foodborne Listeriosis ed. by A.J.
Miller, J.L. Smith, and G.A. Somkuti. Elsevier Science: Amsterdam, The Netherlands, 1990, pp. 137-149,
E. coli O157:H7--Roberts, T. and Marks, S., ``E. coli O157:H7 Ranks as the Fourth Most Costly Foodborne Disease,'' FoodReview, USDA/ERS, Sept-Dec 1993,
pp. 51-59.
salmonellosis--Roberts, Tanya, ``Salmonellosis Control: Estimated Economic Costs,'' Poultry Science. Vol. 67 (June 1988) pp. 936-943,
campylobacteriosis--Morrison, Rosanna Mentzer, Tanya Roberts, and Lawrence Witucki, ``Irradiation of U.S. Poultry--Benefits, Costs, and Export
Potential, FoodReview, Vol. 15, No. 3, October-December 1992, pp. 16-21, congenital toxoplasmosis--Roberts, T., K.D. Murrell, and S. Marks. 1944.
``Economic Losses Caused by Foodborne Parasitic Diseases,'' Parasitology Today. vol. 10, no. 11: 419-423; and Roberts, Tanya and J.K. Frenkel,
``Estimating Income Losses and Other Preventable Costs Caused by Congenital Toxoplasmosis in People in the United States,'' J. of the Amer. Veterinary
Medical Assoc., vol. 196, no. 2 (January 15, 1990) pages 249-256.
N/A indicates item is not-applicable.
ERS is currently working on a sensitivity analysis for their cost
of illness estimates for foodborne illness. The sensitivity analysis
replaces the LS VOSL estimates with estimates found in the literature
on wage-risk studies. Preliminary findings show that the estimates of
the total cost of foodborne illness will increase greatly when these
higher VOSL estimates are used.
FSIS considers that the existing conservative estimates are
appropriate considering the controversy and uncertainty. The
conservative estimates are more than sufficient to justify the
[[Page 38965]]
final rule implementing a new HACCP-based regulatory program for meat
and poultry. This final RIA uses the cost of illness estimates shown in
Table 5.
Another comment stated that the cost of illness estimates are low
because they do not account for increases in productivity. In response,
the Agency notes that ERS used Landefeld and Seskin's estimates for the
value of a statistical life, and those estimates do include an
estimated 1% annual increase in productivity.
One commenter suggested that a methodology based on earning power
may overestimate the value of life where many deaths from foodborne
illness are the very elderly, the immunocompromised and the terminally
ill. This commenter also noted that while all deaths are tragic, from a
strictly economic standpoint many of these tragic cases have little or
no productivity left and in fact are utilizing resources at the rate of
$3,000 to $12,000 or more dollars per month of maintenance.
The cost of illness methodology used by ERS does account for the
fact that older individuals have lower remaining earning power than
younger individuals. This difference was taken into account when
estimating the costs of lost productivity for salmonellosis patients.
Different Landefeld and Seskin estimates of the values of statistical
life were used for the different age categories. The methodology used
U.S. death certificate data to estimate that the average age for
patients who die from salmonellosis is over 65 years. The concept of a
statistical value of life accounts for the fact that older individuals
may continue to work or be retired or be patients under long term
health care.
3. Percentage of Foodborne Illness and Cost of Foodborne Illness
Attributable to Meat and Poultry
The fifth column of Table 5 includes estimates on the percentage of
foodborne illness attributable to meat and poultry products. A separate
estimate has been developed for each pathogen. These estimates are
based on outbreak data reported under the CDC Foodborne Disease
Outbreak Surveillance System and on data from community-based and other
epidemiologic studies. Major data sources are cited in the preamble to
the final rule. An assumption is made in this analysis that the source
of foodborne pathogens, i.e., meat and poultry versus dairy products,
seafood, vegetable, etc., has no effect on the cost of illness. The
Department is not aware of any data indicating that the severity of
foodborne illness cases varies by source of pathogens.
Comments noted that the Department had increased the percentage of
foodborne illness attributable to meat and poultry from the earlier
rulemaking for safe handling labels. One commenter stated that the
Department has not revealed any new information which would support
such an increase.
At this time, data on incidence of foodborne illnesses and the
percentage of cases attributable to different food items are limited.
Estimates by pathogen have been made by experts at CDC and USDA, based
on a variety of studies. However, these are, indeed, estimates: FSIS
does not have exact numbers. The estimates in the 1993 Federal Register
document were relatively crude, assuming that 100% of Campylobacter and
E. coli O157:H7 cases, 96% of Salmonella cases, and 85% of Listeria
cases were foodborne, and that, for all bacterial pathogens, a flat 50%
of foodborne cases were attributable to meat and poultry. The 1995
document looked at the numbers in a somewhat more sophisticated way,
evaluating each pathogen individually and, where appropriate, giving
ranges for, first, percentage of cases which were foodborne, and,
secondly, percentage of cases which were attributable to meat and
poultry. Nonetheless, when all of the various percentages are
multiplied out, estimates of total cases attributable to meat and
poultry were remarkably similar, as shown below in Table 6.
Table 6.--Percentage of Foodborne Illness Attributable to Meat and Poultry
----------------------------------------------------------------------------------------------------------------
Percentage Percentage
of total of total
cases cases
attributed attributed Estimated total Estimated total
Pathogen to meat and to meat and cases, 1993 cases, 1995
poultry <SUP>a poultry,
1993 1995
(percent) (percent)
----------------------------------------------------------------------------------------------------------------
Campylobacter............................... 50 41-53 1,050,000 1,031,250-1,312,500
Salmonella.................................. 48 43-72 921,600 348,000-2,880,000
E. coli O157:H7............................. 50 60 3,834-10,22 46,000-12,000
Listeria.................................... 43 43-48 649-672 763-884
----------------------------------------------------------------------------------------------------------------
<SUP>a Reflects percentage of foodborne multiplied by percentage attributable to meat and poultry.
Most other comments related to the estimates on the percentage of
foodborne illness attributable to poultry. Comments questioned the high
incidence of poultry-related foodborne illness when even, as a
commenter asserted, public health authorities tell consumers that the
problem with poultry meat is not due to consumption because poultry is
cooked. Comments questioned whether cross-contamination in the kitchens
could possibly generate such high levels of foodborne illness. Related
comments suggested that if cross-contamination was such a serious
problem, the data would show more outbreaks and fewer single cases.
Other comments suggested that the cost of salmonellosis attributed to
poultry was high because of the high incidence of Salmonella
enteritidis in eggs and requested that the Agency exclude any foodborne
illness costs associated with eggs, because those issues are outside
the scope of this rulemaking. Another comment cited an Australian
finding that the Campylobacter strains that infect chickens are not the
strains that primarily infect humans.
The Department agrees that undercooked poultry is not a primary
cause of foodborne illness. The preamble to the proposal stated that
the majority of salmonellosis results from cross-contamination. The
best available estimates for foodborne illness do suggest that a high
incidence of illness is attributable to cross-contamination in
kitchens--both household kitchens and food-service establishments.
The comment suggesting that cross-contamination would have led to
more outbreaks makes sense, if the available estimates on incidence
were heavily
[[Page 38966]]
based on outbreak data. However, as mentioned in the proposal, it is
widely recognized that CDC outbreak data do not provide accurate
estimates of foodborne disease incidence. The outbreak data are more
useful in identifying factors that lead to illness and have been used
to estimate proportions of illness attributable to specific food
groups. They do not play a major role in the overall incidence
estimates. The existing incidence estimates are for total cases
including both individual cases and multiple cases. The methodology
used does not distinguish between outbreaks and single cases. Just as
there are unreported individual cases of foodborne illness, there are
unreported cases where entire households or portions of households
experience foodborne illness due to cross-contamination in household
kitchens. As discussed above, the estimates of foodborne illness were
derived from both CDC outbreak data and community-based epidemiologic
studies.
The outbreak data (two or more individuals ill from the same
source) are compiled by CDC from reports that are voluntarily submitted
from state and local health authorities. The laboratory reporting
system for Salmonella only captures information on those cases where a
patient sees a doctor, the doctor collects a stool culture and sends
the culture to a participating laboratory and the laboratory can
perform the specific diagnostic test. The estimates for overall disease
incidence are derived using both databases plus data collected from
population-based studies in specific geographic areas. The current
(initiative) collaborative surveillance project should improve the
estimates in the future.
The comment referring to the Australian finding is referring to an
article by Korolik, et al, published in the May 1995 issue of the
Journal of Clinical Microbiology, entitled, ``Differentiation of
Campylobacter jejuni and Campylobacter coli strains by Using
Restriction Endonuclease DNA Profiles and DNA Fragment Polymorphisms.''
The study was undertaken to determine if DNA fingerprinting
technologies could identify strains of Campylobacter in chickens that
cause disease in humans.
FSIS reviewed the article and concluded that the study did not
refute U.S. epidemiologic studies showing that approximately 50% of
human Campylobacter infections are due to poultry. To confirm FSIS's
interpretation of the study, a staff member contacted the author, Dr.
Victoria Korolik, in Australia. She confirmed that her study does not
shed doubt on the role of poultry in human Campylobacter infections.
4. Pathogens Addressed by the Rule
While the proposed rule indicated that HACCP systems will be
designed to control all public health hazards, the preliminary benefits
analysis assumed that the primary benefits will come from controlling
the three most common enteric pathogens of animal origin: Campylobacter
jejuni/coli, E. coli O157:H7, Salmonella and one environmental pathogen
Listeria monocytogenes. Two other pathogens--Clostridium perfringens
and Staphylococcus aureus primarily become or create hazards in meat
and poultry products as prepared in restaurants, other commercial
kitchens, and in homes. Consequently, the proposed regulatory program,
which focuses on the manufacturing sector, will not significantly
affect the presence of these organisms on meat and poultry products.
The public comments did not address the assumption that the
proposed rule would have the most impact on the four pathogens
identified above and that benefits would be most appropriately
discussed in terms of reducing the level of these pathogens. This final
RIA will continue to assume that the HACCP-based regulatory program
will have the most impact on the four pathogens identified in the
preliminary analysis.
The preliminary benefits analysis also included an assumption
concerning the percentage of the four pathogens that contaminate the
meat and poultry supply at inspected establishments or grow from
contamination that occurs at inspected locations. Based on the expert
judgment of FSIS microbiologists, the preliminary benefit analysis
assumed that 90 percent of the four pathogens result from contamination
that occurs at inspected establishments.
The public comments did not directly address the estimate that
slaughter and processing establishments are the source of 90 percent of
enteric pathogen contamination. There were, however, a large number of
comments that cited studies or estimates that show or indicate that the
majority of foodborne illness can be attributed to improper cooking,
recontamination and other mishandling and abuse in the food service and
home environment. Many comments cited data presented in the 1994 CAST
Report which ``demonstrated'' that only 6.9 percent of outbreaks were
``attributable'' to the food processing establishments. Other comments
referred to ``a well-recognized fact that 97 percent of the problems
with foodborne illness occur outside the realm of state and federal
inspection.'' Other comments attributed the 97 percent figure to a
Special Report by the American Association of Meat Processors. These
types of comments were presented in a manner indicating that the
commenters believe that the data attributing ``cause'' to the food
service or home environment directly contradicts the Agency's estimate
that inspected establishments are the source of 90 percent of the four
pathogens addressed by this rule.
In response, the Agency points out that the studies cited by
commenters concluding that high percentages of foodborne illness are
attributable to factors such as temperature abuse and mishandling do
not conflict with either the assumption that slaughter and processing
establishments are the source of 90 percent of enteric pathogen
contamination or the assumption discussed later concerning the
effectiveness of HACCP in reducing that contamination. Occurrence of
foodborne disease is a multi-step process. The first, and critical,
step is the introduction of a pathogen into or onto the raw product. If
a pathogen is present, then subsequent temperature abuse or mishandling
may permit bacterial counts to increase to levels which increase the
likelihood that illness will occur; mishandling may result in cross-
contamination of other foods which are not cooked before being eaten;
or improper cooking may not kill all pathogenic bacteria present in the
product. In these instances, it may be said that the illness was
``caused'' by improper handling. However, disease would not have
occurred if the pathogen had not been present on the raw product in the
first place.
The CAST study included a table showing factors contributing to the
occurrence of 1,080 outbreaks occurring from 1973 to 1982. That table
consisted of data from the CDC national foodborne disease surveillance
system that was published in an article in the Journal of Food
Protection by Frank L. Bryan in 1988. The CAST study and journal
articles use terminology like ``factors that contribute'' and address
the location or type of employee/consumer where any mishandling or
mistreatment of food occurred. The focus of these studies is to enhance
our understanding of the sequences of events and behaviors that lead to
foodborne illness since behavioral modification for the food preparer
and consumer at the end of the food chain may have the greatest impact
on the incidence of foodborne disease. Many of the comments are written
in a manner that blurs the distinction
[[Page 38967]]
between factors in the kitchen that may permit an outbreak to occur
from slaughter-origin contamination and those that would have caused an
outbreak despite the absence of contamination of the raw ingredients.
The comments referring to the CAST study or directly to CDC
estimates have not interpreted the Foodborne Disease Outbreak
Surveillance Data correctly. The standard CDC foodborne disease
outbreak report form does not include a question about whether the food
processing industry was involved, and while many foodborne outbreaks
have a chain of causation, investigators may differ in their assessment
of the point or points in the chain to which primary responsibility for
occurrence of the outbreak should be assigned.
The Bryan article used for the CAST study had the following summary
concerning the role of food processing establishments: ``Many of the
animals that enter abattoirs are either infected or contaminated with
foodborne pathogens and further spread occurs during processing. Hence,
abattoirs and raw-product processing establishments must accept some of
the blame of spreading salmonellae and other pathogens to many
carcasses and pieces of meat. These products are major sources of
pathogens for food-service establishments and homes where further abuse
(e.g., inadequate cooking or cross contamination) leads to outbreaks of
foodborne illness.''
The comments have not provided any basis for changing the expert
judgment of FSIS microbiologists that inspected establishments are the
source of 90 percent of the four pathogens addressed by the final rule.
This final benefits analysis is based on this assumption.
5. Effectiveness of the Rule in Reducing Pathogens
In accordance with the assumption that meat and poultry
establishments are the source of 90 percent of the four pathogens
addressed by the rule, the preliminary analysis calculated the benefits
under a scenario where the proposed rule would eliminate essentially
100 percent of those pathogens that enter the meat and poultry supply
at inspected processing establishments. In other words, for the
preliminary analysis, FSIS calculated an estimate of maximum benefits
by assuming the rule would eliminate 100 percent of the 90 percent.
By assuming this scenario, FSIS was not predicting that it believed
that the rule would result in elimination of 100 percent of those
pathogens in the manufacturing sector. Rather, the Agency was
acknowledging that it has responsibility for having a food safety
objective that recognizes the scope of the problem and attempts to
reduce pathogens in that sector as much as possible, since without
pathogens, no amount of subsequent abuse would result in foodborne
illness.
By presenting a sensitivity analysis in the proposal, FSIS intended
to clarify that the benefit estimates were a maximum and not a
prediction of what is likely to happen. The distinction was unclear to
many commenters who expressed doubt that the proposed HACCP program
would result in a 90 percent reduction in pathogens. A large number of
comments on the potential effectiveness of HACCP programs contrasted
the FSIS estimates with those contained in the recent study by the
Institute of Food Science and Engineering, Texas A&M University, titled
``Reforming Meat and Poultry Inspection: Impacts of Policy Options,''
(hereafter referred to as the IFSE study). Both FSIS and IFSE estimates
are useful as assumptions rather than as quantitative predictions of
potential effectiveness of HACCP.
The ISFE study examined four policy options for addressing
pathogens in the meat and poultry supply. One option called for
mandatory HACCP for inspected slaughter and processing establishments
and estimated that mandatory HACCP in inspected establishments would
produce a 20 percent reduction in pathogens. The difference in the FSIS
and IFSE estimates is not based on data but on assumptions for
different ``HACCP'' scenarios.
The HACCP program scenario considered in the IFSE study did not
assume a mandatory pathogen reduction performance standard. Requiring
process control without a standard could lead to processes that are
well controlled at unacceptable pathogen levels. The Agency would agree
that such a situation would result in less pathogen reduction. FSIS
believes that a standard is necessary to encourage innovation and
provide the impetus for continuing improvement and increasing
effectiveness. In estimating effectiveness, the IFSE study noted that
``with experience and additional research, it is possible that higher
levels of reduction in pathogens could be achieved * * *''.
Another major difference between the two program scenarios is that
the IFSE program does not include a prerequisite requirement for SOP's.
SOP's could cover potential sources of enteric and environmental
pathogens that are not be covered under a HACCP plan. However, as
discussed in Section I, this analysis discusses benefits of SOP's in
terms of increased productivity for inspection resources and clarity of
responsibilities.
Several comments refer to the IFSE estimates as being more
objective or ``scientific'' than those in the Agency's analysis. The
IFSE authors characterize their own effectiveness estimates as ``the
consensus judgment of the task force'' or ``the most reasonable
expectation.'' The IFSE estimates are judgments, as are the Agency's
estimates.
A general comment related to the effectiveness issue stated that
while HACCP remains an interesting theoretical concept, it is still
only a concept that has never been tested on a meaningful scale under
actual meat establishment conditions, and never proven to significantly
improve the microbial quality of the finished product. Although HACCP
has been tested in food processing establishments to the satisfaction
of scientists, food technologists, and industry management to produce
safe food, the Agency recognizes that the potential effectiveness of
HACCP in reducing pathogens within a regulatory framework is unknown at
the present time. FSIS conducted a pilot HACCP study in nine
establishments from 1991 to 1993. Findings regarding pathogen reduction
effectiveness were inconclusive. FSIS did not receive any data during
the comment period from establishments currently operating HACCP
systems. Rather than select an arbitrary effectiveness estimate, or use
the maximum potential 100 percent estimate from the preliminary
analysis, this RIA will present a range of effectiveness estimates and
show the minimum level necessary to generate net benefits.
6. Estimated Reduction in Cost of Foodborne Illness
Several comments focused on the issue that the relationship between
pathogen reductions at the manufacturing stage and foodborne illness
reductions is unknown. The comments recognize that the proposal did
acknowledge that little data exist on the relationship between pathogen
levels and incidence of illness. One comment pointed out that FSIS
recognized that the pathogen testing requirements that are part of the
proposal will help to elucidate the relationship between pathogen
contamination and foodborne disease. The commenter concluded that it
did not seem reasonable for the Agency to rely on an assumption, whose
very validity can only be tested by the implementation of the proposal
under examination, to justify the proposal.
[[Page 38968]]
Other commenters concluded that the Agency needed to develop better
data or complete a thorough risk assessment that would establish the
public health benefits of pathogen reduction before proceeding.
The comments asking for better data or requesting a thorough risk
assessment are not comments on the cost-benefits analysis. These
comments imply there is insufficient evidence to support new pathogen
reduction efforts. This issue is addressed in the preamble to the final
rule. The comments have made a policy judgment with which the
Department does not agree.
For the benefits analysis included with the proposed rule, FSIS
assumed that a reduction in pathogens will lead to a corresponding
proportional reduction in foodborne illness. The Department notes that
the IFSE study referred to favorably by many commenters used the same
method for estimating public health benefits as did FSIS, i.e., a
reduction in pathogens leads to a proportionate reduction in illness
and death. The Agency is aware that the proportionate reduction method
is an assumption that has not been tested or validated. However, the
Agency also recognizes that research methodology for relating pathogen
levels at establishments to incidence of illness is in its early
developmental stages. Risk models for foodborne pathogens are likely to
develop as the basis for regulatory decision-making in the future. The
Agency believes the implementation of mandatory HACCP will improve food
safety and protect public health while research in modeling risk
associated with foodborne pathogens continues.
The Agency has and continues to support any effort to improve the
quality of data and methodology available for risk assessment of
illness caused by foodborne biological agents. FSIS, FDA, CDC, and
local public health departments are collaborating with state health
departments and local investigators at five locations nationwide to
identify more accurately the incidence of foodborne illness, especially
illness caused by Salmonella and E. coli O157:H7.
G. Summary
The final rule addresses four pathogens that are estimated to cause
from $1.1 to $4.1 billion in annual illness and death costs
attributable to meat and poultry products. The rule addresses 90
percent of that cost of illness or from $0.99 to $3.69 billion
annually. FSIS recognizes that the actual effectiveness of the final
requirements in reducing pathogens is unknown, and presents a range of
benefits based on reducing varying percentages of the $0.99 to $3.69
billion in annual cost of foodborne illness addressed by this rule.
References
International Commission on Microbiological Specifications for
Foods (ICMSF). 1980. Microbial Ecology of Foods: Factors Affecting
Life and Death of Microorganisms. Volume I. Academic Press, New
York. Pp. 215-231.
Rolfe, R.D. 1991. Population dynamics of the intestinal tract.
In: Colonization Control of Human Bacterial Enteropathogens in
Poultry. Ed. L.C. Blankenshipp, J.S. Bailey, N.A. Cox, S.E. Craven,
R.J. Meinersmann, N.J. Stern. Academic Press, Inc., New York. Pp.
59-76.
Centers for Disease Control (CDC). 1988. Campylobacter isolates
in the United States, 1982-1986. In: CDC Surveillance Summaries.
June 1988. MMWR 1988; 37 (No. SS-2:1-13).
Blaser, M.J. & L.S. Newman. 1982. A review of human
salmonellosis: I. Infective dose. Reviews of Infectious Disease.
4(6):1096-1106.
Buchanan, R.L. & R.C. Whiting. 1996. Risk assessment and
predictive microbiology. J. Food Protection. 31-36.
Burmaster, D.E. & P.D. Anderson. 1994. Principles of good
practice for the use of Monte Carlo techniques in human health and
ecological risk assessments. Risk Analysis. 14(4):477-481.
Council for Agricultural Science and Technology (CAST). 1994.
Foodborne pathogens: Risks and consequences, Report No. 122, p. 87.
Haas, C.N. 1983. Estimation of risk due to low doses of
microorganisms: A comparison of alternative methodologies. Am. J.
Epidemiol. 118:573-582.
National Research Council. 1983. Committee on Institutional
Means for Assessment of Risks to Public Health. Risk Assessment in
the Federal Government: Managing the Process. National Academy
Press, Washington, DC p. 191.
Tappero, J.W. et al. 1995. Reduction in the Incidence of Human
Listeriosis in the United States; Effectiveness of Prevention
Efforts? Journal of the American Medical Association. 273(14):1118-
1122.
Gellin, B., C.V. Broome, R. Weaver and A.W. Hightower.
[Listeriosis Study Group.] Geographic Differences in Listeriosis in
the U.S. (Abstract). In Program and Abstracts of the twenty-seventh
International Conference on Antimicrobial Agents and Chemotherapy.
p. 155. Washington, DC: American Society for Microbiology, 1987.
V. Cost Analysis
A. Introduction
The final HACCP rule includes several regulatory components all
directed at improving process control in meat and poultry operations in
order to reduce the risk of foodborne illness associated with meat and
poultry products. The requirements of the final rule are organized
around the following three sections:
<bullet> Requirements that all inspected establishments develop and
implement sanitation Standard Operating Procedures (SOP's) within 6
months.
<bullet> Requirements that all inspected establishments develop and
implement HACCP programs within the 18 to 42 month time period
following publication. Scheduling will be based on establishment size.
<bullet> Requirements that (1) all establishments slaughtering
cattle, swine, chickens, or turkeys, or producing a raw ground product
from beef, pork, chicken or turkey comply with new pathogen reduction
performance standards for Salmonella and (2) all establishments
slaughtering cattle, swine, chicken or turkeys implement microbial
testing programs using generic E. coli within 6 months. Compliance with
the pathogen reduction performance standards for Salmonella will be
required at the time the establishment is required to implement HACCP.
This cost analysis is presented in three sections. The first
section describes the methodology used in generating cost estimates.
The next section addresses the regulatory flexibility designed to
reduce the burden on small business. The last section presents the cost
estimates for each regulatory requirement. For each broad requirement,
the discussion of the cost estimates is organized using the following
five topics:
<bullet> Summary of the requirements in the final rule identifying
any changes from the proposal.
<bullet> Review of the cost estimates from the preliminary RIA.
<bullet> Summary of the comments related to the preliminary cost
estimates.
<bullet> Response to the comments.
<bullet> Final cost estimates.
B. Methodology for Cost Analysis
The final pathogen reduction/HACCP rule includes regulatory
requirements that are directed at improving the control over food
processing operations. In general, compliance with these requirements
requires expenditures of time, i.e., employee hours to develop plans,
monitor critical control points, record findings and collect and
analyze samples. This final RIA is based on time required by four
categories of employees that were defined in the supplemental cost
analysis. These include the following:
<bullet> Quality Control manager earning $25.60 per hour.
<bullet> Supervisors or QC technicians that review findings and
records at $18.13 per hour.
[[Page 38969]]
<bullet> Laboratory technicians earning $18.13 per hour.
<bullet> Establishment employees/production workers that would
monitor sanitation and HACCP programs or collect samples at $12.87 per
hour.
The four categories of wages are based on 1993 data adjusted for
1994 dollar inflation from the Bureau of Labor Statistics and Meat and
Poultry Magazine and include a 33 percent overhead requirement for
benefits such as health insurance and retirement contributions. Unless
otherwise noted, the analysis assumes that all establishments and
employees work a standard 52 week, 260 day, 2080 hour work year.
This final cost discussion is based on retracing the steps and/or
calculations of the preliminary analysis and discussing related public
comments in the appropriate sections. Other comments that are related
to the analysis but do not reflect directly on the methodology are
summarized at the end of the analysis in Appendix A.
This analysis makes frequent references to the Enhanced Economic
Database. In 1994, the Research Triangle Institute (RTI) took a
compilation of existing FSIS databases containing establishment
production or inspection data and added data on annual sales and
employment from sources that included Dun and Bradstreet and American
Business List databases. Actual estimates for annual sales and number
of employees were available for approximately 80 percent of the
establishments. In other cases, estimates for sales and number of
employees were developed using the employment/sales data for
establishments producing the same type and volume of product.
The enhanced database includes production data (number of head
slaughtered, pounds of product produced) from 1993 for all federally-
inspected establishments in operation as of August 1994. The
preliminary analysis and this final RIA combine 1993 production data
with the population of federally and state- inspected establishments
that were in operation as of August 1994. As of August 1994, there were
6,186 federally inspected and 2,893 state inspected establishments.
These 9,079 establishments include a total of 11,719 ``operations''--
2,597 red meat slaughter operations, 364 poultry slaughter operations
and 8,758 further processing operations.
This final analysis assumes a constant level of 9,079 inspected
establishments. The analysis does not attempt to account for costs
associated with exits from or entries into the marketplace. For
operations that are entirely new, or include a new processing
operation, the requirements for HACCP plans and sanitation SOPs will
increase the one-time, up-front cost of entering the market. If
marketplace entry involves the purchase of an existing business, the
business will already have an existing HACCP plan and sanitation SOP.
In these cases, the acquisition cost of the business would include the
value of the existing HACCP plan and SOP.
There should be minimal additional cost for HACCP and SOP plan
development for new construction that expands a firm by replicating an
existing operation in a new location. This type of new establishment
can apply HACCP and SOP plans that have been developed for a similar
existing establishment. This analysis has assumed that each
establishment is independent and has not reduced cost estimates to
account for firms that operate several similar establishments.
The preliminary analysis developed cost estimates for three sizes
of manufacturing establishments. Most of the costs that involve
employee time are influenced by a number of factors including the
physical size of the establishment, the volume of production, the type
of production practices and the number or production lines. The
preliminary analysis used the data on annual sales developed by RTI
because the sales data correlated reasonably well with size and
production volume data and the Agency had an estimate of sales for
6,186 federally inspected establishments.
For the preliminary analysis the Agency defined a large
establishment as one with over $50 million in annual sales, a medium
establishment as one with between $2.5 and $50 million and a small
establishment as one with less than $2.5 million in annual sales. For
calculating costs, the Agency collected data from the field based on
these three size categories. Public comments provided good reason to
change size definitions for implementation (regulatory flexibility)
purposes and the Agency has done so for the final rule. This does not
affect the accuracy of proposed or current cost estimates based on
previously collected data. The final analysis uses the old categories
for presenting cost data to facilitate comparisons and minimize
confusion. To summarize, this cost analysis uses the terms high, medium
and low volume producers for cost presentation that involves average
establishment costs and uses the terms large, small and very small
business for discussing regulatory flexibility. The cost and
flexibility principles do not overlap in this analysis.
Commenters pointed out that in comparing total costs with the value
of current production, the preliminary analysis did not address impacts
on producers, i.e., the costs that would be passed back to livestock
producers. FSIS recognizes that some costs will be passed back to
producers in terms of lower prices for live animals and other costs
will be passed forward in terms of higher consumer prices. Other costs
may have to be absorbed by slaughter and processing establishments.
Because the necessary knowledge of empirical cost structures and supply
and demand elasticities is inadequate, FSIS does not offer any
quantitative estimates of the distribution of costs of this rule on
various sectors of the production and marketing chain. The aggregate
cost estimate establishes an upper bound on the costs any sector might
ultimately bear.
There are two types of potential costs that were not addressed in
the preliminary cost analysis. The first type of cost is the cost of
taking corrective action when routine monitoring of a CCP finds a
deviation from a critical limit. The critical limit could be associated
with assuring compliance with existing regulatory requirements or it
could be a limit set to assure compliance with the new pathogen
reduction standards for Salmonella or the criteria established for
generic E. coli. Corrective action would also occur when FSIS would
find a problem with either a HACCP plan or a sanitation SOP.
The second type of potential cost is related to the question of
whether existing processing methods are adequate to meet the pathogen
reduction performance standards for Salmonella and the criteria for
generic E. coli. It is expected that some establishments will have to
make permanent changes to their existing production practices to have a
HACCP-based program that assures compliance with the new standards and
criteria. The final rule raises a third type of potential cost when it
outlines the Agency's plans for using the results of its own Salmonella
testing program for regulatory purposes. Whether or not this testing
leads to industry testing costs depends on whether the government
testing indirectly forces an establishment to regularly conduct its own
testing.
The preliminary analysis did address a fourth category of potential
costs that includes the cost of necessary materials, such as
thermometers and test kits, that establishments will need to
[[Page 38970]]
systematically monitor their processes. Recognizing that the rule does
not make any equipment obsolete, the preliminary analysis suggested
costs of from $10 to $20 per establishment. These costs were not
included in the overall cost summary.
Potential costs are addressed in this final analysis under Section
V.D.2., Costs of Meeting Pathogen Reduction and Microbial Sampling
Requirements.
C. Regulatory Flexibility
The Regulatory Flexibility Act (P.L. 96-354) requires analyzing
options for regulatory relief for small businesses. This section
reviews the regulatory relief provided in the proposal, responds to
comments related to the definition of small business used in the
proposal and summarizes the regulatory relief for small business
provided for in the final rule. In Section II, this analysis addressed
the option of providing an exemption for small business noting that
comments on an exemption were mixed with a substantial number of
comments from small businesses strongly opposing an exemption.
The proposed rule intended to spread the implementation of HACCP
over a three year period. To minimize the burden on small
establishments, they would be given a maximum time of 36 months to
develop and implement their HACCP plans. A small establishment was
defined as one with annual sales of less than $2.5 million.
The decision to use the above definition generated a large number
of comments. ``Very small'' establishments commented that they could
not compete with a relatively ``large'' business with annual sales of
$2.5 million. For example one commenter stated that: ``calling an
establishment, small, that produces $2,500,000 worth of product
annually is not fair to those establishments producing far less.''
Other comments suggested that by defining small at the $2.5 million
level, the Agency demonstrated that it does not understand what a small
business is. Comments from businesses with annual sales of $2.5 to
$10.0 million or even $25.0 million stated that they should also be
considered small businesses. Commenters also pointed out that other
Federal agencies use different definitions. For example, one commenter
noted that OSHA uses 50 employees as their criterion for a ``small
business.'' Others commented that FSIS should or must use the existing
definition of fewer than 500 employees published by the Small Business
Administration (SBA).
Several comments promoted a set of requirements distinguishing
``small'' from ``very small'' establishments. ``Very small''
establishments would only be required to implement the proposed
provisions on sanitation standard operating procedures, antimicrobial
treatment of carcasses, and time and temperature provisions. They would
be exempt from routine microbial testing and long-term provisions of
HACCP as long as annual sales do not exceed $1 million (not counting
``pass through''). The establishments would still be subject to
incidental sampling for microbial testing as determined by the
Administrator. Required implementation of the three near-term
initiatives would be 12 months after publication of the final rule.
The ``small'' establishments (between $1.0 and $2.5 million) would
be required to implement SOPs, antimicrobial treatment, time and
temperature provisions, and limited routine sampling, in proportion to
the number of slaughtered animals and/or poundage of processed
products. The establishments would still be subject to incidental
sampling for microbial testing as determined by the Administrator. They
would be exempt from long-term provisions of HACCP as long as annual
sales, as defined above, do not exceed $2.5 million. The required
implementation of all near-term initiatives would be six months.
There were other comments that suggested variations on the above
definitions and requirements for ``small'' and ``very small''
establishments. For example, one State department of agriculture
recommended the same requirements for ``small'' and ``very small''
establishments but suggested that size criteria based on head
slaughtered or pounds produced would be more practical. Another State
department of agriculture recommended that a ``every small'' plant be
defined based on the number of employees (no more than 20 full-time),
slaughter volume (no more than 2,500 animals per year), or processing
volume (100,000 pounds of meat and/or poultry products per year). The
recommendation suggested that a plant in this category would be
required to implement the provisions of the proposed rule pertaining to
sanitation SOP's and time-temperature requirements. Antimicrobial
treatment of carcasses would be voluntary, and such a plant would be
exempted from microbial testing as proposed. Implementation of a HACCP
program would be initially voluntary, and phased in with considerations
in the areas of documentation and record-keeping for the limited work
force.
FSIS has considered the above regulatory framework for ``small''
and ``very small'' establishments. Some of the suggestions are no
longer applicable because major provisions of the proposed rule have
been dropped. FSIS believes it has addressed the other concerns in more
appropriate ways.
FSIS was aware of SBA Size Standards during the development of the
proposed rule. If FSIS used the size standard for meat and poultry
``manufacturing'' firms, over 94 percent of the federally inspected
establishments would meet the criterion of having fewer than 500
employees. FSIS is also aware that there are six different SBA size
standards that apply to the 6,415 FSIS official establishments. FSIS
determined the SBA size standards by themselves are not appropriate for
meeting FSIS's need to sequence HACCP implementation.
Table 7 shows the distribution of 6,415 official establishments by
Standard Industrial Classification (SIC) code. The SIC codes were
developed to promote the comparability of statistics describing various
facets of the Nation's economy. The SIC codes were used as part of the
Enhanced Economic Analysis Database developed by Research Triangle
Institute to represent all FSIS inspected establishments. As can be
seen from Table 7, a significant portion of official establishments are
not in an SIC Code for manufacturing. Food manufacturing establishments
have a 4-digit SIC Code beginning with 20. The Census of Manufacturers
published by the Department of Commerce characterizes the meat and
poultry manufacturing industry by summarizing data for SIC Code 2011--
Meat Packing Establishments, SIC Code 2013--Sausages and Other Prepared
Meats, and SIC Code 2015--Poultry Slaughtering and Processing. The SBA
Size Standards in Table 7 are published in the Code of Federal
Regulations--13 CFR, Chapter 1, Section 121.601.
In a written comment, the Office of Advocacy, Small Business
Administration claimed that FSIS was wrong in concluding that one-third
of federally inspected establishments would have the maximum time for
compliance with HACCP requirements using the criterion of $2.5 million
in annual sales. In supporting their claim, they cited U.S. Census
Bureau data. However, Census data do not accurately describe the
federally inspected meat and poultry industry. As shown in Table 7, the
problem is that less than half of the firms are classified in the three
4-digit SIC Codes identified above that define meat and poultry
manufacturing. FSIS addressed this data
[[Page 38971]]
problem by contracting with RTI to develop a more accurate economic
profile of federally inspected meat and poultry establishments.
Table 7.--Establishments Standard Industrial Classification
----------------------------------------------------------------------------------------------------------------
Cumulative
SIC code Standard industrial Number of number of SBA size standard
classification establishments establishments
----------------------------------------------------------------------------------------------------------------
2011.............. Meat packing 1,503 1,503 500 employees.
establishments.
5147.............. Meats and meat products. 1,312 2,815 100 employees.
2013.............. Sausages and other 939 3,754 500 employees.
prepared meats.
2015.............. Poultry slaughtering and 438 4,192 500 employees.
processing.
4222.............. Refrigerated warehousing 356 4,548 $18,500,000.
and storage.
5421.............. Meat and fish markets... 309 4,857 $5,000,000.
5144.............. Poultry and poultry 268 5,125 100 employees.
products.
5141.............. Groceries, general line. 238 5,363 100 employees.
5812.............. Eating places........... 156 5,519 $5,000,000.
2038.............. Frozen specialities, nec 139 5,658 500 employees.
5142.............. Packaged frozen foods... 130 5,788 100 employees.
5411.............. Grocery stores.......... 95 5,883 $20,000,000.
5149.............. Groceries and related 65 5,948 100 employees.
products, nec.
9999.............. Not applicable.......... 63 6,011
2032.............. Canned specialities..... 61 6,072 1,000 employees.
2099.............. Food preparations, nec.. 55 6,127 500 employees.
Other............. All other SIC codes..... 288 6,415
----------------------------------------------------------------------------------------------------------------
Note: The Enhanced Economic Analysis Database uses the number of active establishments as of August, 1994 and
identified 6,415 establishments as active official establishments. Of these 6,415, a total of 229 were
identified as cold storage/ID warehouses, universities or churches. From the 6,415 total, 6,186 federal
establishments were classified as processing, slaughter or combination operations. nec--(Not Elsewhere
Classified).
The final rule provides for sequencing HACCP implementation by
establishment size, using the SBA definition of a small manufacturing
business, i.e., a small business is an establishment with fewer than
500 employees. Those establishments with 500 or more employees will be
referred to as large establishments. In addition, in response to
comments that there are hundreds of ``very small'' or ``micro''
establishments, the Agency will classify an establishment as ``very
small'' if it has either fewer than 10 employees or annual sales of
less than $2.5 million.
This sequencing of HACCP responds to a large number of comments
requesting that small businesses be given a longer period of time to
implement HACCP requirements. Many small businesses stated they did not
want to be exempt, but asked for more flexibility in implementing
HACCP. Some commenters specifically requested five, eight or 10 years
to implement HACCP.
While the final rule does not provide for longer periods of five,
eight or 10 years, it does substantially extend the implementation
period for hundreds of small and very small establishments.
To illustrate, the proposed rule would have required HACCP plans
in over 2,100 establishments producing raw ground product within 12
months. Under the final rule, over 1,800 of those establishments will
have either 30 or 42 months to implement HACCP. The smallest 5,127
establishments (2,893 state and 2,234 federal) will have an additional
six months. The proposed rule called for implementation of a HACCP
system in all ``small'' establishments by 36 months; the final rule
allows 42 months for the newly defined ``very small'' category.
Table 8 illustrates the distribution of 6,186 federally-inspected
slaughter, processing, and combination establishments used for the
sequencing of HACCP implementation in the proposed rule and in the
final rule. There are 496 more establishments in the two smaller
categories than there were in the proposal. As shown in Table 8, there
are 353 large, 2,941 small and 2,892 very small federally-inspected
establishments.
Table 8.--Size Categories for Federally Inspected Establishments
------------------------------------------------------------------------
No. of
Establishment category Definition establishments
------------------------------------------------------------------------
Proposed Rule
------------------------------------------------------------------------
High volume....................... >$50 million........ 849
Medium volume..................... $2.5-$50 million.... 3,103
Low volume........................ <$2.5 million....... 2,234
Total........................... .................... 6,186
------------------------------------------------------------------------
Final Rule (Sequencing of HACCP)
------------------------------------------------------------------------
Large............................. <gr-thn-eq>500 353
Employees.
Small <SUP>a........................... 10-499 Employees.... 2,941
Very small <SUP>b...................... <10 Employees or 2,892
<$2.5 Million.
Total........................... .................... 6,186
------------------------------------------------------------------------
<SUP>a New definition of small includes 2,445 establishments that were medium
volume establishments plus 496 that were high volume for the
preliminary analysis.
<SUP>b New definition of very small includes the 2,234 establishments that
were low volume establishments plus 658 that were medium volume
establishments for the preliminary analysis.
D. Final Cost Estimates
1. Sanitation Standard Operating Procedures
a. Summary of Requirements. The final rule requires that all
inspected establishments develop and implement Sanitation SOP's within
6 months after publication of the final rule. The proposed rule would
have required the implementation of SOP's within 90
[[Page 38972]]
days. To facilitate the development of SOP's and to provide maximum
flexibility, the Agency will not prescribe any specific format or
content but will provide guidelines to assist inspected establishments
in developing written SOP's. There will not be any FSIS approval of the
written documents. With the exception of the implementation schedule,
the requirements for SOP's in the final rule are the same as those in
the proposed rule.
b. Review of Preliminary Cost Estimates. The preliminary cost
analysis identified separate costs for SOP plan development and SOP
recordkeeping where recordkeeping was defined as observing or verifying
procedures, recording findings, reviewing records and maintaining
files. FSIS assumed that the Sanitation SOP's would be developed by a
quality control manager at a cost of $25.60 per hour. FSIS estimated
that it would cost an average of $128, $256 and $640 for low, medium
and high volume establishments to develop Sanitation SOP's.
The preliminary cost analysis assumed that Sanitation SOP's
observation and recording for low, medium and high volume
establishments would take 15, 25 and 45 minutes per day by an employee
earning $12.87 per hour and that supervisory review of records would
take 5, 10, and 20 minutes by an employee earning $18.13 per hour. In
developing these time estimates for recording and reviewing records,
FSIS recognized that the time required would be influenced by a number
of factors including the physical size of the establishment, the volume
of production, the type of production practices and the number of
production lines. The estimates are based on program judgement of the
time required to conduct two sets of sanitation observations per day,
one for preoperational sanitation procedures and one for operational
sanitation.
Using the above inputs, the annual costs for recording and
reviewing Sanitation SOP's records for low, medium and high volume
establishments would be approx