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CHAPTER 7
CONCLUSIONS AND RECOMMENDATIONS
CONCLUSIONS
The Role of Risk Assessment
Risk assessment is a specialized and systematic means for
organizing and presenting information about various types of health
hazards, including those associated with the consumption of broiler
chickens. Because it requires explicit, consistent, and logical
treatment of data and their associated uncertainties, and consideration
of current scientific knowledge, risk assessment is one of the most
valuabl e tools available to serve regulatory agencies e Therefore, FSIS
should begin a continuing program of more formalized applications of
risk assessment based on a refined risk model, such as that proposed by
the committee in Chapter 3, to analyze specific risks associated with
poultry and to evaluate alternative strategies for managing these
risks.
The data necessary to provide accurate quantitative risk
assessments are not always available and vary greatly among the types
of hazards presented by broiler chickens. Thus in many instances,
particularly in connection with microbiological hazards, only
qualitative assessments can now be done. ~ ~ ~
The consistent use of the
conceptual framework and model for all assessments ensures that current
information is being used in the most effective possible way to guide
risk management.
Although gaps in knowledge and lack of data limit the extent to
which quantitative risk assessment can now be done, FSIS should
consider the use of more formalized, and ultimately quantitative, risk
assessment to serve as a foundation for important decisions involving
issues of human health. Quantification is needed to clarify the
magnitude of the various sources of human health risks and to provide a
more defensible logic for decision making. Qualitative reasoning, even
qualitative reasoning made more systematic by the use of a risk model,
is often too vague and prone to error to serve as a satisfactory basis
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for definitive decisions bearing on human health. However, this
reasoning does not necessarily lead to the conclusion that FSIS needs a
highly detailed, comprehensive risk-assessment system to support its
decision making. Some initial efforts to quantify the framework chosen
should reveal whether further quantitation will be cost effective and
the extent to which risk assessment, in general, will be useful.
Risk assessment is not the only component of a regulatory program.
Although protection of the public from significant health risks is the
ultimate goal of any FSIS program, the types and range of risk-
management options are influenced by legal, regulatory, and historical
precedents that cannot be ignored by decision makers. The committee
has dealt only with the ways in which risk assessment can assume a more
prominent role in the decisions made by FSIS in the absence of such
constraints.
The Risk Model
The committee believes that the conceptual framework and risk model
developed in Chapter 3 and examples of their application in assessing
the risks presented by microbial contamination and chemical residues
(Chapters 4 and 5) should serve as a guide in future FSIS
data-gathering and risk-assessment activities. In Chapter 6, the
committee used this analytical approach to identify risk-management
options and to evaluate FSIS programs and activities. In so doing, it
learned much about the adequacy of current FSIS programs. The
recommendations set forth below are based on this evaluation.
Current FSIS Programs
The committee's use of the risk model in earlier chapters of this
report was designed not only to illustrate how risk assessment can be
used to evaluate current programs and to guide the development of
future ones but also to answer the following question: Are current
FSIS inspection techniques reasonably related to the level of public
health risk associated with various components of the broiler chicken
risk model?
By applying the risk model developed in Chapter 3, the committee
observed that the traditional postmortem inspection system cannot deal
with several sources of risk at certain points in production and
distribution due to limitations of FSIS authority. Among these are the
assignment of acceptable daily intake (ADI) or other levels of
tolerable intake for chemical residues, monitoring of poultry feed and
drinking water to prevent contamination of the products, and education
of the consumer regarding safe poultry preparation practices.
Effective risk-management programs must include a range of activities
that fall outside traditional postmortem inspection. Some of the
committee's recommendations derive from this conclusion.
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Microbial Hazards. As stated in Chapter 3, the committee believes
that the present system of inspection provides little opportunity to
detect or control the most significant health risks associated with
broiler chickens. Although information is not sufficient for the
committee to conclude that the FSIS inspection program has no public
health benefits, the weight of the evidence does suggest that the
current program can not provide effective protection against the risks
presented by microbial agents that are pathogenic to humans. The
committee believes that alternative and potentially less costly
strategies, which are described below, may provide greater benefits to
public health. An integral component of these strategies is the use of
a statistically based sampling plan, rather than the traditional
approach of 100% inspection. Some details of a possible approach are
described in the recommendations presented below under Sampling
Procedures .
Current inspection procedures do not significantly reduce
contamination of broilers by microorganisms that are pathogenic to
humans, nor were they designed to do so. Even if they were to be
responsible for small reductions in contamination levels, however,
there are further opportunities for increasing or decreasing microbial
contamination after the products leave FSIS control. For example,
cross-cont~ination can occur during distribution and food preparation;
proper cooking car effective! y eliminate microbial risks . These
factors affect both Salmonella and Campylobacter, which are among the
major causes of food-borne morbidity among humans in the United States.
Since the current system of postmortem poultry inspection is not an
effective device for managing this public health problem, several types
of corrective action should be taken. Furthermore, other microbial
risks need to be investigated with greater vigor, and additional data
should be sought so that the magnitude of the public risk associated
with microbial contaminants can be assessed more accurately. These
constitute the committee's central conclusions regarding FSIS
inspection programs. The recommendations presented below derive from
them.
Chemical Hazards. Unlike microbial risks, the relationship between
chemical contamination levels in poultry at the slaughterhouse and on
the dinner plate is much better understood. In this case, critical
factors and uncertainties in the risk model concern the nature,
likelihood, and level of chemical residues and the health effects
produced by the ingestion of those residues. The problem is therefore
analogous to other chemical risk management problems, which have been
addressed effectively through an approach based on the establishment of
maximum permissible concentrations.
It seems clear, however, that there has been insufficient inves-
tigation of the pass ible extent of the problem of chemical res idues in
poultry. A comprehens ive analysis of the potential risk of chemical
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residues in poultry was therefore not possible, but in examining the
limited data available the committee found no evidence that such
residues pose a sigificant threat to public health. The committee's
recommendations in this area are designed to encourage systematic
investigation of the problem and to increase the efficiency of current
inspection efforts.
Current monitoring programs are designed primarily to detect a
given frequency of tolerance violations. This objective may not be
compatible with public health protection--the principal goal of FSIS
inspection. It does not, for example, take into account the fact that
the potential public health risks posed by chemical residues vary
considerably. Several recommendations concern the means to reorient
current monitoring programs.
In general, it appears that FSIS programs are directed more toward
detecting of macroscopic problems rather than toward investigating the
origins of health hazards and finding ways to solve them. The
detection of microbial and chemical contaminants as part of a quality
assurance program designed to assist in revealing their sources would
be a commendable addition to current efforts. The general tone of all
recommendations derives from these observations.
RECOMMENDATIONS
General
Risk assessment based on the conceptual framework and a risk
model such as that provided in Chapter 3 should be used to
guide FSIS risk-management programs. Examples of how these may
be applied to assessments of microbiological and chemical
hazards and to program evaluation are given ~ n Chapters 4, 5,
and 6.
Current poultry inspection programs are primarily concerned
with detecting diseased and damaged poultry so that very few of
the problems detected by this system are threats to public
health. Because federal funding of the inspection program is
intended to protect public health, it seems clear that such
funds should be expended in direct proportion to the magnitude
of the public health risks. Qualitative risk assessments
should be used to determine where the major risks occur, how
they might be controlled, and consequently to which aspects of
the inspection program funds should be diverted. When needed,
quantitative risk assessments may be required to elucidate
complex health risks.
Rather than focusing on one procedure, such as bird-by-bird
inspection, as the primary component of an inspection process,
FSIS should direct its efforts toward the establishment of a
comprehensive quality assurance program. Such a program would
consist of several components, one of which might be
organoleptic inspection.
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.
An important component of any quality assurance program is a
statistically based random sampling protocol. The committee
recommends that FSIS establish such a sampling program as part
of any future modifications of its inspection system.
Emphasis should be shifted from detection to prevention of
problems at the earliest feasible stage in production to
increase the effectiveness of poultry risk-management
activities.
In the areas of risk management outside the purview of FSIS,
the agency should attempt to maintain a close liaison with
responsible agencies D
Microbiological Contaminants
.
.
.
FSIS should use the tools of risk assessment to establish
priorities for a risk-management program to protect consumers
from microbiological hazards using the tools of risk
assessment. Relevant activities are:
Identify and evaluate potentially pathogenic microorganisms
found on poultry products.
Determine the potential for exposure to an infectious dose
of pathogens derived from contaminated poultry products.
Evaluate the potential public health impact of failure to
control each of the identified microbial hazards.
FSIS should identify and monitor the critical control points of
the poultry sys tem at which microorganisms pathogenic to humans
are introduced. This will assist industry in identifying
production practices that result in exposure of consumers to
poultry-borne pathogens.
· Because fecal contamination is a primary source of the
microbial load on broiler carcasses' PSIS should identify and
monitor critical control points within dressing procedures to
prevent soilage of carcasses by intestinal contents and
carcass-to-carcass contamination.
· In describing the risk model (Chapter 3), the committee
identified a variety of points in the slaughtering process
where operations involving machinery have the potential to
influence contamination levels. Application of this risk model
to microbial risks in Chapter 4 led to the conclusion that
several of these operations had a critical bearing on the
levels of Salmonella on carcasses. Hence, greater emphasis
should be given to the operation, maintenance, and improvement
of machinery (e.g., pluckers and chillers) to reduce the
likelihood of microbial contamination in slaughterhouses.
FSIS should begin to lay the groundwork for a shift from the
organoleptic inspection of each broiler chicken to a program
that is more likely to have a substantial impact on human
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.
health and disease. Further development of quantitative health
risk assessment will be an essential tool in this change.
Educational programs for people who handle raw broilers in
slaughterhouses, at retail, and during food preparation in the
home and in commercial establishments should be established or
intensified to alert them of the potential risks and to
instruct them in proper food handling practices. As part of
this effort, all poultry products inspected by FSIS should be
labeled at retail to inform consumers about the optimal ways to
protect themselves from microbial hazards.
Community-based surveillance of pathogens on poultry products
and of food-borne disease incidence in humans should be
intensified to measure the success of programs undertaken to
reduce the prevalence of human pathogens on market-ready
poultry and the direct impact of program activities on the
public's health.
FSIS should ensure that it can achieve the above objectives
either by its own activities or through agreements with other
agencies having appropriate authority and expertise.
Chemical Residues
.
To protect consumers from chemical residues in poultry
products, FSIS should adopt a r~sk-management program that
includes the following activities (some of which would require
close coordination or agreements with other agencies):
Identify hazardous substances that could appear as residues
in poultry products.
Establish ADIs or other levels of tolerable daily intake of
such substances by humans.
Establish tolerances for residue levels in edible poultry
products and institute enforcement programs to ensure that
those levels are not exceeded.
Establish levels of intake for poultry through diet,
drinking water, or other sources to ensure that tolerances
in poultry products are not exceeded.
Establish control programs to ensure that poultry feed,
drinking water, or other sources of chemical residues do
not contain chemicals of concern at levels exceeding those
identified in the preceding activity.
Establish procedures that provide for efficient removal of
contaminated poultry products from commerce.
Identify priorities for each activity described above using
the concepts and tools of risk assessment.
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FSIS should categorize chemicals according to source, as
described in Chapter 5, to assist in the identification of
risk-management responsibilities and obj ectives .
FSIS should ensure that it has in place programs to carry out
all activities not clearly assigned to FDA (tolerance setting
for additives and drug residues), to EPA (tolerance setting for
pesticides), or to other agencies.
In USDA research programs, emphasis should be given to
accidental chemical contaminants, environmental contaminants,
and chemicals formed during processing, storage, and heating of
poultry products. The current Exploratory Testing Program
should be expanded to include research on the following
essential topics: the toxic properties of chemical agents (to
assist In setting acceptable intake levels)9 levels in poultry
products, and methods of chemical analysis.
In cooperation with FDA and EPA, FSIS should learn the extent
to which the existing data on chemicals intentionally
administered or applied to poultry or poultry feed are adequate
to support current tolerance levels.
A prevention program to monitor poultry feed and drinking water
should be seriously considered as the first line of defense
against residues in poultry products. Such programs could be
undertaken using procedures recommended by FSIS. Close
cooperation with FDA may be necessary to achieve this
objective. Data necessary to implement such a program (i.e.,
data on maximum acceptable feed and water levels) should
already be available for intentionally used substances.
Additional research is necessary to establish feed and drinking
water limits for environmental chemicals and accidental
contaminants.
The committee recommends that priorities for monitoring feed,
water, and poultry products and the intensity of the monitoring
efforts be directly related to the relative magnitudes of risk
posed by candidate substances should they escape detection and
enter the marketplace. Priorities for research should be
assigned in the same way. A methodology for assessing relative
risks is presented in Chapter 5 (Activity 8~.
FSIS should periodically assess the public health risks of
chemical residues in poultry products, using data collected
from its residue monitoring program together with data on
toxicity Monitoring and enforcement should be increased or
decreased, according to the results of these assessments.
Sampling Procedures
The quality and safety of poultry products are linked closely to
the occurrence of chemical and microbiological contaminants that may
originate from a variety of sources. To ensure the safety of retail
products, contaminants must be minimized. This is most effectively
accomplished by detecting them as early as possible in the poultry
system and preventing their introduction by contolling the source, for
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example, by sampling and testing the water and feed of growing
chickens. However, preinspection components of the poultry system are
outside FSIS jurisdiction. Therefore, any sampling program adopted by
FSIS incorporating, for example, an effort to monitor microbial counts
during slaughter should be complemented by collaborative efforts with
FDA and EPA to monitor the microbial load of feed that might have been
contaminated by rodents or that might contain improperly sterilized
animal by-products. One possible scheme for monitoring chickens during
slaughter is presented below using the format of ~ three-stage sampling
scheme.
The committee recommends that FSIS develop and maintain close
liaison with programs that monitor the acceptability of feed and water
supplied to growing chickens and substantially expand its own sampling
program to assess the quality of poultry products and, most
importantly, the human health hazards of freshly slaughtered birds. To
accomplish this, FSIS should consider the following three-stage
sampling scheme developed by the committee.
In the first stage, a random number generator (functioning
independently from plant quality control programs), a counter, and a
signal attached to the line could flag birds with a probability (~) of
removal from the line and mark them for detailed inspection. The
sampling fraction ~ might be set at 1/500 or 1/5,000 (or higher or
lower), depending on plant history, past performance of the grower, and
other factors. Plant inspection staff should have a role only in
determining how many birds are chosen, not which birds are chosen.
Sampled birds would be marked to identify flock and time of inspection,
for example, and hung on a rack for organoleptic examination in groups
(perhaps by flocks) in a manner substantially more detailed than at
present. This sample inspection would of course not preclude
additional inspection of the present type or other types that might be
deemed appropriate by the inspector in charge; it provides a minimum
for FSIS involvement, not a maximum. This first-stage inspection would
have several purposes:
to maintain awareness of the quality of the product at this
stage, including detection of gross disease and malfunctioning
equipment;
to ensure that FSIS can fulfill its statutory mandate;
to provide direction for further studies, especially laboratory
studies of microbial and chemical hazards;
to exert pressure on poultry processors to apply inspection
procedures that conform to acceptable standards; and
to provide data that could serve as a teas is for further
modification of the sampling system, e.g., in the size of the
samples, in inspection techniques, and in objectives.
The committee recognizes the appearance of a disjunction between
earlier statements that organoleptic inspection has no demonstrated
health value and this recommendation to continue organoleptic
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inspection of a small percentage of slaughtered birds. There is no
contradiction, however, since the recommended inspection of the sample
is not intended to detect and condemn defective birds individually but,
rather, to provide a continuing source of information about how the
poultry industry responds to the shift from treatment to prevention of
problems, to ensure that plant inspection does not deteriorate to the
extent that new health hazards are presented, and to maintain awareness
of changes in a flock's condition or in equipment performance that may
have health impli cations . It may in time become apparent that this
phase of sampling can be omitted under some conditions, for example,
when a producer has a very strong quality control program of its ohm
and a long history of minimal problems in the samples, but the
committee does not recommend the complete omission of this step under
exis tiny conditions .
In the second stage of sampling, most birds selected in the first
stage would be returned to the line, but a random subsample would be
retained for still more detailed study, including simple laboratory
studies for microbial load and chemical residues at the plant. The
sample must again be strictly random, perhaps by rack location
(randomized anew each time). Sampling fractions might be anywhere from
1/20 to 1/500, depending again on the past record of the supplier and
the past performance of the plant. The purpose of this stage is
surveillance for specs fic, direct microbial and chemical risks to
health to ensure a timely response
may be fully processed and shipped
available, but the primary goal of
and correction as needed. Flocks
before any of the test results are
this sampling would have been met,
that is, to develop a needed information base, not now available, on
health hazards as they appear at this very critical point in the
process. Recall of birds or parts found to have very serious problems
might be feasible. Thus, an effort should be made to find and
implement rapid testing procedures that will make it possib] e to remove
contaminated birds before they reach the retail market.
In the third stage, a further random subsample of the second stage
would be frozen or otherwise preserved and sent to a central laboratory
for studies not feasible at the plant. This would in essence continue
and expand the present scope of NRP sampling, and methods and sampl ing
fractions should be adjusted to both the information need and the work
load that NRP can accommodate. The purpose and justification would be
similar to those supporting present NRP activities . Chemical testing
would probably dominate this stage, but the committee believes that
opportunities for further microbial testing should be examined by
FSIS. This subsample should be subjected to morphologic and etiologic
diagnoses to help build a data base against which future program
activities can be measured.
The co~Tunittee also recommends that the present size and composition
of the NRP sample be reexamined in light of data needs and resource
allocations within the overall inspection program proposed by the
committee. With the present random sampling of 300 chickens per year,
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some plants and some large producers may not be sampled for years at a
stretch and even major problems that are localized in space or time
(accidents) may be overlooked and thus not resolved in a timely
fashion. In short, the stated goal of a 95% probability of finding a
chemical contaminant present in 1% of birds slaughtered during a single
year may not be sufficiently protective of the public health to meet
current expectations. However, it would be unrealistic to sample the
entire U.S. population of chickens as if they are a homogeneous group.
The sample size required would be unmanageably large. Instead, FSIS
should develop an appropriate sampling structure based, for example, on
homogeneous and useful units like rearing groups, or random lots of
birds characterized by some common feature such as their point of
origin. (Recommendations for matching sampling rate to relative risks
are presented above under Chemical Residues.)
Sampling of feed, water, and processed products is likely to be
less complex than sampling of birds on the line, and FSIS already has
programs in place or models to follow. The committee emphasizes,
however, that expert technical support should be provided to ensure
that sampling plans meet program goals in a technically sound and
cost-effective manner.
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Representative terms from entire chapter:
risk model
