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Executive Summary
GENERAL FINDINGS
The balance of progress in the reduction of certain human foodborne ill-
nesses following implementation of the Hazard Analysis and Critical Control
Point (HACCP) system in various areas of the food industry is decidedly favor-
able. The technical, financial, and educational efforts made by industry to imple-
ment HACCP and by the regulatory agencies to audit such implementation are
commendable, but further improvements are warranted. The committee believes
that the emphasis of food safety regulatory agencies must continue to be on
prevention, reduction, or elimination of foodborne hazards along the food con-
tinuum.
In addition to specific issues related to each food group included in the study,
several overarching issues were raised during the committee's deliberations.
Despite improvements made in the area of food safety, the translation of science
to practice is at best difficult in a regulatory environment. Because of the inherent
deliberative nature of governmental bodies, scientific tools must be adopted and
novel approaches to food safety must be sought. The need for regulatory control
must be balanced with the need for regulatory flexibility and the expectation that
an agency's actions reflect the most current and effective scientific methods
available to protect the public health. However, the food safety community's
understanding of science-based methodologies and concepts such as risk assess-
ment or food safety objectives is limited, and much of the data needed to develop
science-based strategies are often incomplete, nonexistent, or require extensive
resources to generate. Furthermore, none of the scientific tools available to sup-
1
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2
SCIENTIFIC CRITERIA TO ENSURE SAFE FOOD
port the development of food safety criteria is a panacea; they all present limita-
tions, such as gaps in research data, that need to be recognized and considered.
A second issue noted by the committee was the need to improve the manage-
ment and use of food safety data to ensure that foodborne diseases are identified
as early as feasible and that the origin of foodborne hazards and the most effec-
tive interventions to prevent, reduce, or eliminate them are identified. This leads
the committee to conclude that there is also a need to better coordinate existing
and emerging food safety information systems.
Third, the committee noted that the approach to developing, implementing,
and enforcing food safety criteria, including performance standards, varies among
regulatory agencies. Implementation problems, including questions about the
authority of regulatory agencies to enforce performance standards, have contrib-
uted to diminishing the effectiveness of new regulatory measures aimed at con-
trolling old and emergent foodborne hazards and have prompted many to ques-
tion the effectiveness and appropriateness of the current system. As a result,
implementation and enforcement activities need to be considered by regulators
when developing food safety criteria.
Summary of Recommendations
.
Food safety regulatory agencies are applying a host of new control measures,
from mandating the use of HACCP to increasing testing, with varying degrees of
success, to ensure the safety of the food supply. A collective effort is needed to
further improve the safety of food, and the following actions should be pursued:
· Congress should require the development of a comprehensive national
plan to harmonize the foodborne disease surveillance that is con-
ducted by public health agencies with the monitoring of pathogens
across the food production, processing, and distribution continuum
that is conducted by food safety regulatory agencies. Congress should
allocate funds not only to develop and implement this plan, but also to
enhance programs such as FoodNet, PulseNet, eLEXNET, foodborne out-
break reporting and data sharing, and other national foodborne disease
surveillance systems conducted by public health authorities.
Congress should grant the regulatory agencies clear authority to
establish, implement, and enforce food safety criteria, including per-
formance standards, and the flexibility needed within the administra-
tive process to update these criteria; it should allocate funds to enable
the regulatory agencies to undertake pilot studies and develop and main-
tain databases to support the development and updating of food safety
. .
cntena.
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EXECUTIVE SUMMARY
3
· The U.S. Department of Agriculture should take the following specific
measures regarding scientific criteria, collecting data, and improving
the safety of meat and poultry products:
Periodically conduct baseline surveys to evaluate the microbiological
status of carcass, trim, ground products, and ready-to-eat products, at
processing and at retail.
Implement criteria for generic Escherichia cold levels for ground beef
using the current generic E. cold criteria for carcasses as the model,
and handle the resulting data from carcasses and ground beef through
a national, anonymous database.
Develop a Salmonella performance standard for beef trim intended
for grinding and reevaluate the current Salmonella performance stan-
dard for ground beef. Require that all beef trim for grinding be
exposed to some verified pathogen reduction intervention.
Expand testing of E. cold 0157:H7 to include trim destined for grind-
ing so that contaminated trim can be diverted to further processing
with verified interventions.
Urgently undertake research on the ecology of E. cold 0157:H7 and
other closely related serotypes in beef, from the farm through the
trim, to identify appropriate control points.
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4
SCIENTIFIC CRITERIA TO ENSURE SAFE FOOD
.
Until information on the ecology and mode of transmission of E. cold
0157:H7 is available, and other effective preventive or corrective
controls can be applied, only cooking to a high enough temperature
or sufficient irradiation can ensure the safety of ground beef. The
irradiation process does not replace the need for proper cooking. The
committee urges regulatory and health authorities to (1) advise those
members of the public who would prefer to minimize the risk of this
product to cook irradiated and nonirradiated ground beef products to
the appropriate temperature, (2) require these products to be clearly
labeled with a warning of the potential for harm if not properly
cooked, and (3) expand educational efforts to the public and target
commercial and noncommercial food service managers and workers.
Establish a research focus on intervention trials at all stages of the
meat and poultry production process, from farm to table.
The Food and Drug Administration (FDA) should take the following
specific measures regarding scientific criteria, HACCP, imported
foods, and improving the safety of seafood, produce, and dairy products:
Include a process validation protocol in the Fish and Fisheries Prod-
ucts Hazards and Control Guide and appoint an advisory committee
to periodically update this guide.
Develop strategies to ensure the safety of imported seafood and
produce by focusing on pathogen intervention strategies prior to ship-
ment and on international harmonization of standards.
Expand research on risks associated with many specific practices in
the fresh produce sector, and on the potential for and significance of
internalization of pathogens into fresh produce.
Implement targeted educational programs to inform the public about
the risks of consuming raw milk and raw milk products.
Work with industry to conduct research to assess the pathogen reduc-
tion efficacy of cheese manufacturing conditions and to develop
science-based performance standards for reduction of targeted patho-
gens in finished cheese products.
Along with state authorities, consider requiring clear and concise
labeling to identify cheeses manufactured from unpasteurized milk.
· State health authorities should ban the sale of raw milk, as has already
been done by FDA in interstate commerce.
To assist the regulatory agencies in harmonizing the language in future food
safety regulations, the committee developed or adopted definitions for several
key terms as presented in Box ES-1.
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EXECUTIVE SUMMARY
s
KEY ISSUES
Regulatory Authority and Flexibility to Enact, Enforce.
and Update Food Safety Criteria
Legal challenges to actions taken by regulatory agencies in response to viola-
tions of established food safety criteria have cast doubts on the agencies' authority
to enforce criteria. While the committee did not undertake an analysis of these
challenges, this situation should be promptly addressed through Congressional
action.
Moreover, the current administrative process to modify food safety criteria is
too cumbersome to allow appropriate and timely updating of these regulations to
keep up with scientific and technological progress. To remedy this lack of flex-
ibility, Congress should enable regulatory agencies the ability to incorporate
flexibility into the administrative process so that food safety criteria can be effi-
ciently adjusted to meet future public health goals. This flexibility includes incor-
porating new processing or assessment techniques and allowing the agencies the
ability to change a performance standard to align it with the best contemporary
scientific knowledge.
Regulatory agencies, in turn, need to be consistent in auditing and enforcing
compliance with established criteria. Furthermore, because of the rapid growth of
food imports, it is essential that regulatory agencies properly monitor and enforce
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SCIENTIFIC CRITERIA TO ENSURE SAFE FOOD
compliance with established performance standards and guidelines in imported
foods.
Basing Food Safety Regulations on Science
A major step in advancing a science-based food safety system has been the
implementation of HACCP in various sectors of the food industry. The efforts
made by industry and regulators to this effect are commendable and should
continue.
Regulatory agencies should follow a strategy that combines the best avail-
able data with the best expert judgment, as an appropriate, science-based means
to establish food safety regulations. Scientific tools such as Microbiological Risk
Assessment, Food Safety Objectives, and Statistical Process Control are avail-
able to regulators when developing and monitoring compliance with regulations.
Good science-based policies should allow flexibility and encourage innovation
with minimal regulatory revisions. This implies a regulatory framework that
specifies results, but not the methods used to achieve these results. It also implies
flexible criteria that can be efficiently changed in response to changing public
health goals.
The Need to Link Food Safety Criteria to Public Health Objectives
Food safety criteria have the common objective of protecting or improving
public health. Therefore, science-based food safety criteria must be clearly linked
to the public health problem they are designed to address. This link, which is not
always present in current regulations, would also provide a means to measure the
effectiveness of new and existing regulations. To establish this link, data from
foodborne disease surveillance programs and from monitoring pathogen con-
tamination in foods must be made compatible and should be integrated.
Timely collection, analysis, and dissemination of surveillance data are essen-
tial to minimize the spread of foodborne disease outbreaks to a larger population,
particularly in the light of concerns about potential intentional contamination of
food. Internal sharing and comparison of compatible surveillance data, and col-
laboration with international surveillance systems, are also essential. However,
current microbial monitoring of food in the United States is fragmented and often
incompatible with foodborne disease surveillance; this reduces the effectiveness
of much of the monitoring and surveillance. Efforts to standardize methodology
and data reporting methods, such as PulseNet, are beginning to produce invalu-
able information, and their expansion is fundamental to an effective surveillance
system.
Similarly, to collect data that can be compared to foodborne disease surveil-
lance data, there is a need for periodic surveys of pathogen contamination, at
various stages in the production/consumption continuum, of foods frequently
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EXECUTIVE SUMMARY
7
associated with foodborne illness. These data are necessary to identify the opti-
mal locations and means for effective interventions, through appropriate criteria,
that will enhance the safety of foods.
SUMMARY FINDINGS
Tools and Procedures to Establish Science-Based Food Safety Criteria
.
.
.
.
The emphasis of food safety regulatory agencies must continue to be on
the prevention, reduction, or elimination of foodborne hazards along the
food production, processing, and distribution continuum, rather than on
inspection of the end product.
There is a need to define "acceptable levels" of hazard reduction at critical
control points linked to public health objectives. The Food Safety Objec-
tive concept can help establish this link and define these levels, and it can
also provide a theoretical framework to relate performance standards to
public health objectives.
· Failure to develop HACCP plans that are appropriately specific for a
given processing plant, line, and product may contribute to failure of the
plan.
There are inconsistencies in the interpretation and enforcement of HACCP
regulations between and within the regulatory agencies.
· Quantitative microbial risk assessment offers the scientific tools to define
the most effective solutions for lowering consumer exposure to foodborne
microbial hazards.
Statistical Process Control linked to continuous improvement must be a
part of food safety regulations. The concept of "continuous improvement"
is central to food safety.
Depending on the quality of available data, food safety regulatory agen-
cies could use controlled studies, expert opinion, or a combination thereof
to develop science-based food safety criteria. Because of common gaps in
available data and scientific knowledge, the combination strategy is the
optimal science-based procedure to develop food safety criteria.
Efficient and cost-effective collection of appropriate data for scientific
decision-making may be facilitated through ongoing, systematic develop-
ment of databases and targeted pilot studies to address specific data gaps.
· Documenting the limitations of the data and the assumptions used, and
making this information available to the public, provide essential trans-
parency to the process of developing food safety criteria.
When appropriate data are available, a performance standard may be
developed by (1) assuming that all food-processing companies are pro-
ducing food of an acceptable level and setting the performance standard at
a level such that the lowest compliant processor will pass, while all of the
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SCIENTIFIC CRITERIA TO ENSURE SAFE FOOD
noncompliant plants will fail, or (2) setting the performance standard at a
level where only a portion of the processing plants will pass, thus enabling
future adjustments to the standard.
When zero tolerance is used as a performance standard, unique methodol-
ogy issues need to be considered.
Performance standards must be linked to a public health goal and must
incorporate a measure of effectiveness in meeting the public health goal.
Regulatory agencies need flexibility in administrative procedures to up-
date food safety criteria to align them with the best contemporary scien-
tific knowledge.
It is difficult to quantify the individual costs and benefits of performance
standards implemented as part of a broad regulatory change. The thesis
that flexibility allows innovation, borne out in the area of environmental
regulations, may be amenable to extension into the food safety regulatory
environment.
Foodborne Disease Surveillance and the Monitoring of
Microbial Contaminants in Food
Foodborne disease surveillance is essential for defining trends in food-
borne disease, identifying outbreaks, allocating the burden of disease
among food groups, and evaluating food safety programs.
· Compatible bacterial subtype and antimicrobial resistance surveillance
data from humans, animals, farms, and food products should be linked
among federal agencies and state laboratories.
· Systematic sampling of animals for pathogens preslaughter and at point of
slaughter to obtain a clear understanding of contamination routes is lack-
ing. Periodic, systematic, nonregulatory microbiological surveys of food-
processing plants, with sampling at various points, should be conducted to
provide a basis to revise baselines on the prevalence of pathogen and
indicator microorganisms for foods frequently implicated in foodborne
disease outbreaks.
Monitoring microbial pathogens in produce and seafood (domestic and
imported), live animals (on farm and preslaughter), and final products,
and comparison with human isolates through compatible serotyping and
subtyping, would provide data to develop and evaluate food safety inter-
ventions and regulations. Without such data, it is not possible to clearly
establish the contribution of current food safety criteria to improvements
in public health.
Epidemiological and food monitoring data are essential when developing
quantitative microbial risk assessments for use as a basis for food safety
criteria.
.
.
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EXECUTIVE SUMMARY
9
Safety Criteria for Meat and Poultry
· The rationale for the process control performance criteria for fecal con-
tamination is based on the frequency and levels of contamination of beef
carcasses with E. cold and is appropriate. However, if populations of
generic E. cold are extremely low, other testing approaches may be necessary.
The E. cold data collected by industry are not in the public domain. Col-
lection of such data should be extended to ground beef, and all data
should be handled through a national, anonymous repository.
The Salmonella performance standards for carcasses and ground meat are
valid criteria to reduce the levels of salmonellae in or on meat. However,
if the populations or incidence of salmonellae are extremely low, other
testing approaches may be necessary.
The Salmonella performance standard for ground beef products may not
reflect the overall quality of the grinding operation. It may instead be a
reflection of the quality of incoming raw materials.
A Salmonella performance standard or other appropriate criterion is
needed for beef trim intended for grinding.
All meat intended for trim for ground products, especially ground beef,
and including trim from heads, should be exposed to some form of veri-
fied pathogen reduction intervention.
Based on public health data, the zero tolerance policy for E. cold 0157:H7
in ground beef has been insufficient to reduce the rate of human illness
attributable to this microorganism. It is important to emphasize the need
for testing and interventions prior to the grinding operation.
· Information on the ecology and mode of transmission of E. cold 0157:H7
and related serotypes is urgently needed to help develop preventive mea-
sures and effective interventions.
Currently, only cooking to a high enough temperature or sufficient irra-
diation can ensure the safety of ground beef. The irradiation process does
not replace the need for proper cooking.
The guidelines requiring a specific lethality for Salmonella as a critical
control point in HACCP plans for production of cooked beef and poultry
and other related products are not well justified scientifically and have
resulted in an excessively conservative performance standard.
The scientific bases for the stabilization performance standards required
in the production of cooked beef and poultry and other related products
are not clear; the validity of the data and assumptions is difficult to deter-
mine. These standards do not include cured meat products and should not
be applied to these products.
· Development of a standard using a safety margin based on a highly con-
servative worst-case scenario may lead to production of overprocessed
products of inferior quality, as well as to undue economic burdens for the
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SCIENTIFIC CRITERIA TO ENSURE SAFE FOOD
.
.
.
.
.
.
processor. An inadequate safety margin may lead to production of unsafe
products.
Efforts to reduce the pathogenic contamination of animals preslaughter
are a key part of a farm-to-table food safety strategy.
· Substantial declines since 1996 in several bacterial foodborne diseases in
the United States indicate that the collective efforts to improve food safety
are achieving improvements in public health. It is likely that the Pathogen
Reduction/HACCP rule has contributed to the declines in infections caused
by the meat-associated pathogens Campylobacter, Listeria monocytogenes,
and Yersinia enterocolitica; it is also likely, however, that concurrent
changes in distribution, retail, and consumer behavior also played a role.
Measuring changes in consumer behavior, as well as subtyping microbial
pathogen isolates from various food sources and comparing the results
with isolates from human infections, could help define a cause-and-effect
relationship between performance standards and improved public health.
Emphasizing contamination prevention rather than end-product testing to
ensure the safety of meat is justified. The conclusion of previous National
Academies' reports that carcass-by-carcass inspection is an ineffective
food safety strategy remains valid. Meat and poultry processors and regu-
lators should use process control techniques to ensure that performance
standards for meat and poultry are met.
Safety Criteria for Seafood
Mandatory seafood HACCP has made positive contributions to seafood
safety; further benefits will depend on continuing education and technical
innovation. FDA's Fish and Fisheries Products Hazards and Control
Guide (the Guide) is both innovative and useful.
A structured protocol for process validation that addresses criteria for
qualifying "processing authorities" and for structuring sampling plans,
experimental designs, and appropriate methodologies is lacking in the
Guide. Similarly, a regulatory protocol is necessary to apply new, rapid
analytical methodologies to process validation and routine verification.
· Appropriate control of some chemical hazards in seafood is satisfactorily
achieved through restrictions on harvesting sites or by using vessel and
plant records. End-product testing provides a useful verification tool for
control of these hazards.
The implementation of postharvest treatments to progressively reduce the
average number of annual reported illnesses attributed to raw oysters
required by the Model Ordinance is a unique, flexible approach to safety;
it establishes a public health objective and requires adequate industry
performance without mandating a specific process or performance
standard.
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EXECUTIVE SUMMARY
.
.
11
Screening limited quantities of imported seafood products at points of
entry is not consistent with the preventive concept of HACCP. Prevention
of safety hazards in imported seafood must place greater emphasis on
pathogen intervention strategies prior to shipment. Application of the
Guide to increase seafood safety in international commerce requires im-
mediate attention.
Safety Criteria for Produce and Related Products
Fresh produce safety is of concern because microbial pathogens intro-
duced on fresh produce at any point may be present at the point of con-
sumption.
· Data on risks associated with many specific practices in the fresh produce
sector are lacking. Research is needed on the likelihood of internalization
of pathogens into fresh produce and its underlying mechanisms.
There are concerns about the harmonization of food safety practices for
imported produce. Imported produce should follow the same or equiva-
lent Good Agricultural Practices that are required in domestic production.
Because the use of a D-value concept to calculate thermal processes is
being challenged, the appropriateness of the 12-D process for canning
low-acid foods should be scientifically reevaluated.
Reflecting the array of products and scenarios, FDA has developed guid-
ance documents or required standards to address produce safety. Some
managing strategies that have been implemented are:
Good Agricultural Practices in the field and packing houses; required
Good Manufacturing Practices in fresh-cut operations.
Implementation of HACCP in fruit and vegetable juice production.
The derivation of the sampling program for generic E. cold in fruit
juices involving surface treatment of whole fruit is an excellent exam-
ple of using the combination strategy to develop a performance stan-
dard and could be used as a model when developing future food
safety criteria. In contrast, the justification of the 5-D pathogen
reduction process for juices lacks transparency.
An appropriate action level of 50 mg/kg for patulin in apple juice,
apple juice concentrates, and apple juice products.
Issuing guidance documents on practices to be followed by sprout
producers.
Establishing appropriate pesticide tolerances in produce.
Safety Criteria for Dairy Products
· The application of regulations within the evolving Grade A Pasteurized
Milk Ordinance can be directly credited with reducing the incidence of
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SCIENTIFIC CRITERIA TO ENSURE SAFE FOOD
milk-borne disease. The development, implementation, and enforcement
of the Ordinance provide a good model for an integrated strategy for food
safety assurance. It involves all stakeholders, is based on science, and is
appropriately transparent. This model also provides a specific structure
and mechanism for a biennial review of existing regulations, which could
be used in other sectors of the food industry.
A scientifically appropriate performance standard for the reduction of a
targeted pathogen in finished cheese products is needed.
Research is needed on pathogen survival in cheese made from sub-
pasteurized milk, and educational programs that illustrate the hazards of
raw milk and raw milk-product consumption are warranted. Cheeses
manufactured from subpasteurized milk should be clearly and promi-
nently labeled as such at the point of purchase.
State authorities should ban the sale of unpasteurized milk because of its
inherent risks. Targeted educational programs that illustrate the hazards
of raw milk consumption are also warranted.
Representative terms from entire chapter:
safety criteria
