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8
Overall Findings and Recommendations
The U.S. food safety regulatory system has developed over a period span-
ning more than a century. The regulatory focus has shifted from an overriding
concern about filth and fraud to issues regarding food safety as it relates to
wholesomeness and control of contaminants, particularly those of chemical and
microbiological origin. Because the regulatory authority for food is divided
among several agencies and is based on legislation enacted under the technical,
societal, and political circumstances of the times of their enactment, there are vast
differences in the regulations being applied to various food groups and in the way
the agencies interpret and enforce such regulations. These differences in the
regulatory framework, together with the differences in origin, processing, and
characteristics of the food groups selected for the study, explain the committee's
decision to discuss and evaluate the current safety criteria individually for each
food group.
However, the committee also recognizes that there are issues regarding the
establishment of food safety criteria that are common to all food groups being
studied that should be addressed separately from those specific to each selected
food group. Although most issues regarding policy were intentionally excluded
from the individual commodity discussions, the committee considered some
policy issues closely related to the success of scientific criteria. Thus, the com-
mittee concluded that the authority of regulatory agencies to enact and enforce
food safety criteria within the current regulatory system, and the effectiveness
and consistency of such enforcement, were inextricably linked to its charge and
needed consideration. In addition, discussions regarding the need to regulate food
safety based on science and to link food safety criteria to overall public health
248
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OVERALL FINDINGS AND RECOMMENDATIONS
249
objectives were so central to the committee's charge that these issues constituted
the core of the discussions.
THE NEED FOR REGULATORY AGENCIES TO HAVE THE
AUTHORITY AND FLEXIBILITY TO ENACT, ENFORCE, AND
UPDATE FOOD SAFETY CRITERIA
During its deliberations, the committee concluded that legal challenges to
actions taken by regulatory agencies in response to violations of established food
safety criteria have cast doubt on the authority of the agencies to enforce some
current criteria (e.g., performance standards). While the committee did not under-
take an analysis of the merits of these challenges, it concluded that the doubts
created by these challenges should be promptly addressed through Congressional
action.
.
Congress should give regulatory agencies the clear authority to estab-
lish, and enforce compliance with, science-based food safety criteria,
including performance standards.
Furthermore, the committee concluded that the current process to modify
existing food safety criteria is too rigid to allow appropriate and timely updating
of these regulations to keep up with the fast pace of scientific and technological
progress.
· Congress should give the regulatory agencies the flexibility needed
within the administrative process to update food safety criteria,
including performance standards, so that new scientific knowledge
and technological innovation can be timely incorporated in an effi-
cient manner into these regulations. This flexibility is needed to incor-
porate new processing or assessment techniques and to allow the agencies
the ability to change performance standards to align them with the best
contemporary scientific knowledge.
LINKING FOOD SAFETY CRITERIA TO
PUBLIC HEALTH OBJECTIVES
The committee concluded that defining the means to measure the effective-
ness of a new regulation is an essential factor for consideration during its devel-
opment.
.
Any food safety criterion should be coupled with some sort of veri-
fication measure so that the effectiveness of the criterion can be
assessed.
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250
SCIENTIFIC CRITERIA TO ENSURE SAFE FOOD
Food safety criteria have the common objective of protecting or improving
public health. Therefore, the committee concludes that science-based food safety
criteria must be clearly linked to the public health problem they are designed
to address. To accomplish this, a cause/effect relationship needs to be estab-
lished between contaminants in foods and human disease, that is, to allocate the
burden of foodborne disease among foods and food groups. Knowing the contri-
bution of each food or food group to this burden would allow the selection (or
promote the development) of appropriate interventions and set the basis for estab-
lishing criteria such as performance standards. This knowledge would also allow
regulators to (1) focus on those foods that present the highest risk, and (2) target
effective interventions at Critical Control Points (CCPs) in the production, pro-
cessing, and distribution continuum of such foods. Moreover, such a link would
allow the regulatory agencies and industry to measure the effectiveness of
the selected interventions, and corresponding criteria, such as performance stan-
dards, in controlling the particular hazard and thus improving public health.
.
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, and allocate the
funds to develop and implement this plan.
This plan would aim to establish the burden of foodborne disease and would
be a concerted effort between public health and food safety regulatory authorities.
.
.
To implement such a plan, Congress should allocate funds to expand
the current foodborne disease surveillance programs such as FoodNet,
PulseNet, foodborne outbreak reporting and data sharing, and other
national foodborne disease surveillance systems conducted by public
health authorities.
In addition, Congress should allocate funds for the food safety
regulatory agencies to establish and maintain databases on pathogen
contamination at various stages in the production/consumption con-
tinuum of domestic and imported foods and food groups frequently
associated with foodborne disease. This effort should include studies
to characterize the points in the production/consumption continuum
of such foods where contamination is most likely to occur, so that the
limited current knowledge of the microbial ecology of pathogens and
cross-contamination pathways may be advanced. This knowledge will
be the basis to identify CCPs that would serve to achieve a particular
public health objective.
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OVERALL FINDINGS AND RECOMMENDATIONS
DEVELOPING AND MONITORING SCIENCE-BASED
FOOD SAFETY CRITERIA
251
An executive order exists that requires regulatory agencies to develop food
safety criteria based on science. The committee recognizes that a first major step
in this direction has been the introduction of the Hazard Analysis and Critical
Control Points (HACCP) system in various areas of the food industry.
· The committee strongly recommends that the regulatory agencies
continue to introduce and audit the implementation of HACCP in all
sectors of the food industry, as appropriate.
HACCP
The committee concluded that the positive balance of progress in food safety
after implementation of HACCP, as measured by overall reductions in several
major foodborne diseases, is a tribute to the efforts of industry and the regulatory
agencies to improve food safety. This progress confirms the committee's belief
that industry and food safety regulatory agencies alike must continue to
focus on prevention, reduction, or elimination of foodborne hazards along
the food continuum through a science-based food safety assurance system.
However, the committee also recognizes that there is still much to be done con-
cerning the way HACCP is being implemented by industry and the way compli-
ance with established criteria is being enforced by the agencies. Among the
problems being encountered in HACCP implementation, the committee con-
cluded that inadequate HACCP plan specificity for a given operation, in some
cases, may be the root of certain miscommunications and problems in complying
with HACCP regulations. There is also inconsistency in the approach taken by
the U.S. Department of Agriculture (USDA) and the Food and Drug Administra-
tion (FDA) regarding HACCP implementation. This should be addressed.
.
Continued training in HACCP principles to assure proper implemen-
tation by industry personnel and consistent interpretation and moni-
toring of compliance by inspectors from the regulatory agencies is
necessary.
In addition, the committee recognizes that one of the longstanding limita-
tions of HACCP is that the actual level of hazard control may not be clearly stated
in the HACCP plan. That is, there is little or no guidance on the level of hazard
control expected in an adequately designed and implemented HACCP plan
because the "acceptable level" to which a hazard must be reduced at a CCP is
undefined by HACCP. The committee concludes that, as currently done with
certain performance standards, use of the evolving Food Safety Objective (FSO)
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SCIENTIFIC CRITERIA TO ENSURE SAFE FOOD
concept could, in some cases, help remedy this problem by clearly defining the
level of control needed for adequate Good Manufacturing Practices (GMP), Pre-
requisite Programs, and HACCP systems.
Strategies for Developing Science-Based Food Safety Criteria
Regarding the strategies available to the regulatory agencies to develop
science-based food safety criteria, the committee concludes that it is seldom
possible for regulators to base new regulations strictly on laboratory data or using
only expert opinion.
· Recognizing that it is impossible to fill all data gaps, the committee
recommends that regulatory agencies use a strategy that combines
the use of the best available data and the best expert judgment as an
appropriate, science-based means to establish food safety regulations.
The process described above would have a high degree of transparency and
provide an appropriate strategy to establish regulations in a timely manner.
· The committee emphasizes that transparency that is, effective
communication of the underlying reasons for establishing food safety
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OVERALL FINDINGS AND RECOMMENDATIONS
.
253
control measures, as well as the expected outcome of these measures,
to all stakeholders greatly contributes to acceptance of the mea-
sures. In addition, to maximize transparency in developing new food
safety regulations when limitations in data occur, transparency should
include documenting the limitations of the data, describing the
assumptions used to fill in the data gaps, and making this information
available to the public. This process should actively involve the best
scientists in the field.
Similarly, for flexibility, the committee recommends that the regula-
tory agencies periodically evaluate and update food safety criteria.
To this end, Congress should enable regulatory agencies to incorpo-
rate flexibility into the administrative process, so that these criteria
can be adjusted efficiently to meet future public health goals. The
Pasteurized Milk Ordinance and the Conference for Food Protection pro-
vide models of a specific structure and mechanism for biennial review of
existing regulations.
The committee also discussed what constitutes appropriate data to support
the development of science-based food safety criteria. There are several ways
through which regulatory agencies may obtain appropriate data:
.
Regulatory agencies can conduct or fund pilot studies or risk assess-
ments, or collect appropriate data if these data are not available.
· Regulatory agencies should develop and maintain databases on the
prevalence of specific contaminants for critical commodities.
· Congress should provide adequate resources to develop and maintain
these databases.
Chapters 2, 4, and 6 describe the particular need and justification to maintain
current databases on major food groups, or to develop new ones. In addition to
maintaining these databases, regulatory agencies must continually analyze these
data using basic time series analyses, techniques that are standard in Statistical
Process Control (SPC) methods.
The committee also discussed a number of critical issues that must be
addressed and controlled to ensure good analytical results whether the data are
collected for monitoring purposes for baseline development or for verification
purposes. Ensuring that validated testing and monitoring methods are used
is essential when developing standards or for verifying processes.
The committee recognizes that consideration of unique methodology issues
is necessary when "zero tolerance" is used as a performance standard. The con-
cept of a zero-tolerance performance standard is inextricably linked to the sensi-
tivity of the method employed to detect the offending hazard, as well as to the
sampling strategy employed. Sampling protocols must take into account that a
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SCIENTIFIC CRITERIA TO ENSURE SAFE FOOD
large sample is needed to ensure the absence of the hazard, and that the sample
must be representative of the material being tested.
There are various tools that would facilitate the development of science-
based food safety criteria or their implementation and monitoring within a
HACCP system; these tools are described below.
Risk Assessment
Among the food safety tools discussed by the committee, microbial risk
assessment was deemed to offer a systematic approach to estimating the impact
of pathogenic microorganisms in the food chain. Microbial risk assessment
may help find the most effective solutions for lowering consumer exposure to
foodborne microbiological hazards. Microbial Risk Assessment is rapidly
evolving into a major scientific methodology on which to base food safety criteria.
However, the committee emphasizes that defining microbial dose-response
relationships for foodborne pathogens is essential if more accurate microbial
risk assessment results are desired. Allocation of resources to fund basic
research studies defining these microbial dose-response relationships would help
to remedy this deficiency.
Data on microbial cross-contamination rates suitable for quantitative risk
assessment are only now starting to become available. Precise localization of
where such cross-contamination occurs would require multiple sampling points
in the food production system.
· The committee calls on USDA and FDA to undertake or fund studies
to characterize the points in the food continuum where control may
be most effective and could have the greatest impact on reducing
foodborne disease for food-pathogen combinations where insufficient
knowledge has prevented intervention.
The committee recognizes that no data from a system analogous to the
National Residue Program exist for use in microbial risk assessments, and con-
cludes that a national residue system may represent a useful working model
on which a national pathogen system could be based. Just as the national
residue system can be used to validate chemical risk assessments, such a national
pathogen system would be invaluable in validating microbial risk assessments.
Various other data gaps have been identified that must be addressed before
microbial risk characterization will be seen to be as effective as chemical risk
characterization. However, the committee recognizes that when data are not
available for part of the food production chain, there are strategies such as the use
of predictive models, the use of surrogate data, stochastic simulation using proba-
bilistic distributions, and the use of expert opinions and consults (sometimes
referred to as qualitative risk assessment), to fill such data gaps.
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OVERALL FINDINGS AND RECOMMENDATIONS
255
· Data gaps should not prevent a risk assessment from being initiated,
completed, and serving a useful purpose. However, these data gaps
must be communicated to those requesting the microbial risk assess-
ment, so that they will be aware of its limitations.
The inherently iterative nature of risk assessments allows continual updating
as more and better quality data become available, thereby increasing their effec-
tiveness as tools for policy making.
Food Safety Objectives
The committee examined another evolving food safety tool, the Food Safety
Objective (FSO) concept. Regulatory agencies may find that FSOs represent a
useful concept for establishing a theoretical framework to relate performance
standards to public health objectives. Conceptually, an FSO could be established
on the basis of a quantitative risk assessment of the hazard of interest and would
be consistent with the level of consumer protection that the regulatory agency
deems appropriate to fulfill the public health objective. This concept may be
useful to regulators in developing performance standards for application at the
processing plant level (processing safety objective) such that an appropriate level
of protection against a hazard is achieved in a food product at the time it is
consumed. FSOs may also be useful to industry in selecting interventions that
would ensure that the FSO is achieved, and to the regulators in monitoring
compliance with criteria such as performance standards. FSOs are important
because they enable translation of public health goals into measurements
that food processors are directly able to effect. This is a novel approach that
may allow regulators to close the gap left by HACCP when it defined a CCP
as any point, stage, or step along the food production/processing/distribution
continuum where a hazard can be prevented, eliminated, or reduced to an
acceptable level, but left the acceptable level undefined. An FSO provides the
basis for defining this level.
· The committee recommends that regulatory agencies examine the
potential application of the FSO concept when appropriate.
FSOs can play an important role in modern food safety management by
linking information from the risk assessment processes with measures to control
the identified risk. As more information becomes available, risk assessments
should be updated and FSOs adjusted accordingly. Thus, the committee con-
cludes that the FSO concept may be a useful tool for developing policies that are
consistent with current science and could offer an alternative approach to food
safety management focusing on the protection of human health, while offering
flexibility in achieving that goal.
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SCIENTIFIC CRITERIA TO ENSURE SAFE FOOD
Statistical Process Control
Because manufacturing processes tend to vary over time, processors and
regulators determine compliance with a performance standard either through
end-product testing or process control. Because most food product testing is
destructive, food processors and regulators use acceptance sampling when testing
rather than 100 percent inspection. Acceptance sampling assumes that the product
characteristic that is being measured exhibits relatively stable variation; thus, it is
not designed to identify "hot spots" (i.e., when microorganisms or toxins are
concentrated in a very small portion of the lot), sporadic food safety hazards, or
food hazards that occur at very low levels in a production lot scenarios that are
likely to occur with many foodborne microbial hazards. Although end-product
testing by itself does very little to improve the safety of individual batches of
food, microbiological testing has an absolutely critical role to play in HACCP
plan verification and verification of scientific criteria.
The committee recognizes the value of SPC as a scientific method that
can help the processor to improve the process and the regulator to ensure
compliance with food safety criteria. Processors may use it to verify control of
a food-processing system and to provide information that can be used to critically
examine the system so that appropriate actions can be taken to reduce the likeli-
hood of manufacturing unsafe food products. The committee also recognizes the
potential benefit that could be derived from the use of SPC principles linked to
continuous improvement by food processors, to continually reduce the risk of
producing unsafe food products, and possibly also to reduce production costs. In
addition, the committee believes that for regulators, the most effective procedure
to determine whether a food processor is complying with a performance standard
is to analyze process and product data using control charts, histograms, and
process capability indices. SPC, linked to continuous improvement, provides a
very robust methodology that is easy to monitor from a regulatory perspective.
Therefore, the committee concludes that food safety regulations should
incorporate the concepts of SPC linked to continuous improvement, and
they should require that food processors analyze and maintain records to
ensure that their processes (1) exhibit stable and predictable variation, and
(2) are capable of meeting performance standards. The regulatory agencies,
in turn, must ensure that their professional staff assigned to inspecting or
auditing food-processing plants are trained to enable them to determine
whether a processing plant is properly using SPC techniques to monitor
performance standards and is capable of meeting the performance standards.
.
The committee recommends the adoption of SPC principles linked to
continuous improvement by food processors, as well as incorporation
of such principles by the regulatory agencies into food safety regula-
tions and into the agencies' compliance monitoring procedures of
food processors.
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OVERALL FINDINGS AND RECOMMENDATIONS
Food Safety Economics
257
The committee recognizes that the bulk of current food safety economics
research has not focused on the impact of individual performance standards iso-
lated from overall food safety policy or program (mostly HACCP-based regula-
tions). Therefore, the committee concludes that, at present, it is difficult to
quantify the unique costs and benefits of particular performance standards
implemented as part of a broader regulatory change. In order to complete
such evaluations it would be necessary to have representative, detailed cost data
linked to actual improvements solely due to the particular performance standard
under review. Research in this area is needed.
New Diagnostic Tools
Modern regulatory systems depend on technology to detect deviations from
regulatory criteria. Rapid advances in the field of diagnostic technology under-
score the committee's belief that there is a need for flexibility in any food safety
regulatory approach and development of performance standards. Currently, there
is a perception on the part of regulatory agencies that identification of a pathogen
for regulatory purposes is not "real" unless a microorganism is isolated.
· Regulations need to be changed to recognize that molecular analytical
methods and other rapid methods can produce results of comparable
or greater accuracy than those obtained with traditional culture
techniques, and there must be provision for the use of data obtained
with such methods in regulatory actions. Any regulatory approaches,
including the establishment of performance standards, must have
built into them sufficient flexibility to take advantage of the improve-
ments in diagnostics that will almost certainly occur.
The committee points out that there are limits to what science can deliver.
While science will continue to search for and discover answers to problems
involving foodborne illness, inexpensive answers are often unavailable or im-
practical. Where to draw the line between reasonably cost-effective requirements
that should be implemented and those that would be beneficial but would have
too great an impact on food prices is a question for politics rather than science.
SCIENTIFIC CRITERIA IN MEAT AND POULTRY, SEAFOOD,
PRODUCE, AND DAIRY PRODUCTS
The committee, through its two subcommittees on meat and poultry and on
seafood, produce and related products, and dairy products, examined the main
safety criteria, including performance standards, currently applicable to each one
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SCIENTIFIC CRITERIA TO ENSURE SAFE FOOD
of the sectors of food processing selected for consideration in this report. In so
doing, the committee answered specific questions posed by USDA and FDA in
their respective charges to the committee, as described in the following sections.
Safety Criteria for Meat and Poultry
The Approach to Meat and Poultry Safety
Under the Federal Meat Inspection Act and the Poultry Products Inspection
Act, the USDA, through its Food Safety and Inspection Service (FSIS), inspects
all domestic meat and poultry to be sold in interstate commerce in the United
States. It also inspects plants that export meat or poultry to the United States. In
addition, there are 27 states that operate state meat and poultry inspection pro-
grams. All of these plants operate under a HACCP system.
Microbiological testing of product samples obtained by the federal and state
programs is conducted at USDA-approved laboratories. The committee notes that
these are lagging indicators of process performance by meat or poultry plants
because samples are taken after the product is prepared and packaged and, even
with rapid methods, there is a significant lag time between the collection of the
sample and the analysis of the laboratory data. Although microbiological
samples provide both the plant and regulatory agency with a "score card"
for plant performance, if further significant gains in the safety of the U.S.
meat and poultry supply are to be realized, meat and poultry establishments
need to implement more effective process control measures. As mentioned
earlier, these process control measures should be linked to a systematic continu-
ous improvement process to achieve the necessary level of safety demanded by
the U.S. consumer. In addition, the committee concludes that the regulatory
enforcement of HACCP and associated microbiological performance standards
must be conducted adequately and in a timely manner if it is to achieve its goal of
reducing microbial contamination of raw meat and poultry products and, hence,
of improving public health.
Raw Meat and Poultry Process Control Criteria
The committee concurs that there is general agreement within the scientific
community that generic Escherichia cold is likely the best indicator of fecal
contamination of carcasses. In addition, the committee deems that the FSIS ratio-
nale used in developing the generic E cold process control criteria for raw meat
and poultry made reasonable assumptions and proceeded in a logical fashion.
However, in some instances, the committee notes that if the populations of generic
E. cold are extremely low, the testing may no longer be providing the valuable
information that would allow the processor to continue making improvements in
the process.
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SCIENTIFIC CRITERIA TO ENSURE SAFE FOOD
Lethality: Standards for the Production of Certain Meat and Poultry Products
The committee deemed that the FSIS approach in developing this standard
was not scientifically justified and has resulted in an excessively conservative
performance standard. Also, in examining the safe harbor treatments allowed for
use by processors who cannot or do not wish to validate their own treatments, the
committee expressed concern about the need to ensure proper adaptation of such
treatments to the particular processor's HACCP plan.
Stabilization: Performance Standards for the Production of Certain Meat and
Poultry Products
The committee considers the method used by FSIS to achieve the specified
reductions in Salmonella in ready-to-eat poultry and beef products confusing and
hard to use in determining the validity of either the data or the assumptions made
in setting this standard. Therefore, the committee did not critically review this
performance standard or assess the validity of the assumptions made during its
development. The committee points out that this case illustrates the need for
greater transparency in the development of food safety criteria, as mentioned
earlier. This directive does not cover cured meat products but is being universally
applied to them by inspection personnel.
Animal Drug Residues
The committee recognizes that regulatory review of the use of drugs in food
animals is continuing. The committee concurs that the approved tolerance
level constitutes the performance standard for those chemicals that are used
in animals and have such a tolerance level.
Sanitation Standards
The committee concludes that, although described as "standards," the actual
language in the sanitation regulations includes numerous references to "adequate,"
"preventing sources of adulteration," and "sufficient." Therefore, these regula-
tions provide little in the way of a descriptive and objective "standard" and are
better characterized as "guides."
Economic Cost-Benefit of the Pathogen Reduction/HACCP Rule
As mentioned earlier, the committee concludes that more research is
needed before a proper cost-benefit analysis of specific food safety criteria
can be isolated from the general effects of a wider regulation such as the
Pathogen Reduction (PR)/HACCP rule. However, the committee points out
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OVERALL FINDINGS AND RECOMMENDATIONS
263
that future economic impact assessments of such regulations, when considering
the effectiveness of novel interventions, should rely on data gathered at the pro-
cessing plant level and not only from laboratory or theoretical assessments.
Additional Approaches to Reduce Microbial Hazards in Meat and Poultry
The committee considered the need to move toward an integrated approach
to meat and poultry safety. It concluded that efforts to reduce preslaughter
contamination are likely to be an important part of a comprehensive, farm-to-
table food safety strategy, not only to reduce pathogen load at the slaughter plant,
but also to prevent the hazard from direct contact with infected animals, from
runoff from feedlots and farms, and from contaminated water supplies.
· The committee recommends that USDA conduct or fund research on
the role of nonfecal carriage and commingling prior to and after
slaughter to elucidate the factors that contribute to the microbial
contamination of live animals, carcasses, and products.
· The committee also recommends a research focus on intervention
trials at all stages of the production process of meat and poultry
products.
This is consistent with the committee's view that industry and the regulatory
agencies should continue to place greater emphasis on contamination prevention
rather than relying on inspection and end-product testing to ensure the safety of
meat and poultry.
Safety Criteria for Seafood
There are currently over 350 species of fish that are commonly consumed.
This diversity is expressed as a broad spectrum of sensory attributes, product
forms, and preparations that are particular to seafood. Seafood presents unique
safety concerns that arise from both the intrinsic characteristics of the animals
and the environmental conditions from which they are harvested. In addition,
conditions and handling at harvest and processing, as well as during distribution
and preparation, may enhance or reduce the risk of seafood-borne disease.
The Approach to Seafood Safety
Unlike meat and poultry, the inspection system for seafood safety is under
the jurisdiction of FDA. This system also differs from that in the meat and poultry
industry in that regulatory inspections are not performed on a continuous, on-site
basis.
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SCIENTIFIC CRITERIA TO ENSURE SAFE FOOD
Anticipating that the seafood industry would need assistance in HACCP plan
development and implementation, FDA issued the Fish and Fisheries Products
Hazards and Control Guide, commonly referred to as "the Guide." The com-
mittee recognizes that the Guide is an innovative and useful document that effec-
tively assists seafood processors with the development of their HACCP plans.
To improve the utility of the Fish and Fisheries Products Hazards and
Control Guide, the committee recommends that FDA consider the following
measures:
Introduce a more collaborative process in further developing the
Guide. To this effect, the committee recommends that FDA appoint a
Hazards and Control Guide Advisory Committee.
Further address the issues of expert capability and process.
Develop a protocol to guide process validation. This protocol must
address criteria for distinguishing the creditability of processing
authorities, sampling plans, experimental designs, and appropriate
methodologies. Validation and verification guidelines, including rec-
ommendations for adequate analytical methods and sampling plans,
should also accompany the recommended controls in the Guide.
Develop a protocol to recognize the application of analytical method-
ologies, such as new, rapid test procedures that can be utilized in
process validation and in routine verification.
· Enhance communications to ensure awareness, understanding, and
consistent application of the Guide.
In addition, the committee believes that screening limited quantities of
seafood products at points of entry is not consistent with the preventive
concept of HACCP; hence, prevention of seafood safety hazards in imported
seafood must place greater emphasis on intervention prior to shipment.
· The committee recommends that FDA give immediate attention to
the application of the Guide to ensure food safety equivalence in
international seafood commerce. The committee believes that the
intent of the Guide and its contents need to be clarified to U.S. trading
partners.
Aware that international collaboration is essential to enhance seafood safety,
the committee recommends that FDA initiate an International Seafood Safety
Exchange Program to foster international collaboration in seafood safety research
and training. A common topic for initial consideration could be the development
of Best Aquaculture Practices. The existing FDA Guide, as well as relevant
documents already published by other organizations, could be used as models.
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OVERALL FINDINGS AND RECOMMENDATIONS
Criteria for Control of Chemical Contaminants and Toxins in Seafood
265
The committee examined current safety criteria applicable to seafood includ-
ing tolerances, action levels, and guidelines, and concluded that the specific
scientific basis for each of them differs, depending mainly on the availability of
data about a hazard. The tolerance for methyl mercury content in fish (1.0 ppm)
for example, is appropriately based on the level necessary for consumer safety,
whereas the labeling requirement for sulfite residues (10 ppm) is also appropri-
ately based on the lower limit of analytical capability.
All seafood safety criteria established prior to the seafood HACCP rule
remain in place within the current regulatory system. Therefore, processors must
produce seafood that comply with all relevant food safety criteria. The committee
recognizes that, in most cases, these criteria cannot be used as critical limits for
CCPs in HACCP plans, but can be used as verification criteria when end-product
testing is warranted. Thus, direct monitoring of chemical contaminants using
analytical tests would often be impractical as a CCP because of the significant
variability in concentration for some of these contaminants among geographic
areas. However, this geographical variability makes it possible to reduce con-
sumer exposure to such contaminants through restrictions of harvesting sites.
Therefore, the committee concludes that harvest location restrictions are
meaningful and effective controls for chemical contaminants in seafood.
The committee also recognizes that chemical hazards that are not of environ-
mental origin, such as scombrotoxin, require a different control strategy. Because
monitoring of histamine levels in each fish received at a processing plant would
not be viable, the committee concludes that an alternate procedure based on
review of the harvest records, both time and temperature, associated with
each lot of fish is an acceptable procedure for monitoring histamine levels in
seafood within a HACCP system.
Criteria for Control of Vibrio vulnificus and V. parahaemolyticus in Raw Oysters
As with chemical contaminants, control of pathogenic microorganisms in
shellfish is based on restrictions of harvesting sites. The fecal coliform standard
for shellfish harvesting waters, in turn, is based on the potential presence of
microbial pathogens.
The important role that innovation may play in enhancing seafood safety in
the future is illustrated by the strategy adopted for control of V. vulnificus and the
related species, V. parahaemolyticus, in raw oysters. The committee concludes
that the mandate for postharvest treatment in the model ordinance to reduce
illnesses from consumption of raw oysters is a unique and novel approach to
enhancing seafood safety.
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Safety Criteria for Produce and Related Products
Fruits and vegetables provide many health benefits and are an important
component of the American diet. Consumption of these products in the United
States has increased considerably in the past two decades, with corresponding
increases in the volume of imports. Producers have responded to this increased
demand not only by growing new varieties of fruits and vegetables, but they have
also introduced novelty produce items in the marketplace and developed a large
niche for fresh-cut produce.
Although fresh produce and juices were not traditionally thought to be im-
portant vehicles of foodborne disease, this notion has changed in recent years.
Fresh produce safety is of special concern to the public health community because
fruits and vegetables often do not receive any treatment specifically designed to
kill all microbial pathogens prior to consumption.
The Approach to Produce Safety
There are virtually no criteria or standards for microbiological safety cur-
rently being applied to fresh produce or fresh-cut produce in the United States
other than those pertaining to sprouts and fruit juices. The committee recognizes
that to minimize foodborne disease from being transmitted through fresh produce,
it is necessary to prevent initial contamination of these products and to control the
potential amplification of pathogens in them throughout the production and dis-
tribution chain. Intervention strategies currently being applied in the fresh produce
industry are Good Agricultural Practices in the field and packing houses and
GMPs in fresh-cut operations. The committee recognizes that the principles
that make up the current Good Agricultural Practices recommendations are
necessarily general given the broad range of fruits and vegetables and their
growing conditions, and, like GMPs, they focus on minimizing the potential for
microbial contamination. The committee also recognizes that data gaps on risks
associated with many specific practices in the fresh produce sector make it diffi-
cult to assess which intervention strategies could provide the greatest reduction in
risk. Among these, the committee discussed the issue of potential internalization
of pathogenic bacteria during growth or processing of produce and concluded
that research is urgently needed in this area.
.
The committee recommends that FDA conduct or support additional
studies to determine whether the internalization of bacteria repre-
sents a significant safety hazard in fruits and vegetables.
There have been few attempts to integrate the various steps associated with
production and processing of fresh produce into a farm-to-table HACCP system.
Several HACCP plans have been developed for sprouted seeds, shredded lettuce,
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267
and tomatoes, but complete validation of these plans has not yet been accom-
plished. The committee concludes that currently available data are insuff;-
cient to develop validated HACCP plans for most fresh produce items. Also,
prerequisite programs, such as Good Agricultural Practices and GMPs,
which provide the foundation for HACCP systems, are still being defined
and evaluated for their effectiveness on farms and in orchards. It is expected
that data from ongoing research in this area will provide valuable information to
supplement the basic guidelines.
In view of the trend toward greater importation of fruits and vegetables into
the United States, the committee expressed concern about harmonization of food
safety standards for imported produce. Several international efforts in this direc-
tion are underway, and some efforts are being made by FDA to survey pathogen
contamination in imported produce. Domestic surveys are also being conducted
by FDA and USDA to establish a microbiological baseline to assess the risk of
contamination in the domestic supply; however such efforts need integration.
· The committee reiterates that there is a need to develop a framework
that allows timely sharing of data from surveillance programs on
microbial contamination in specific high-risk fresh and fresh-cut
produce and related products and from human, animal, and environ-
mental isolates, and eventual integration of such data.
· The committee further points to the need for a structured review
process for guidance documents and regulations, with input from a
wide variety of experts from industry, government, and academia,
using the National Advisory Committee on Microbiological Criteria
for Foods model. This review process should be used to modify or
rescind criteria as science evolves.
Pathogen Reduction Criteria in Fruit and Vegetable Juices
As a consequence of foodborne disease outbreaks associated with raw juices
processed at commercial facilities, FDA introduced regulations for all juices
produced for inter- or intrastate sale. This regulation mandates that juice be
produced under a HACCP plan having supporting GMPs and Sanitation Standard
Operating Procedures. In addition, it requires that juice processors achieve at
least a 5-log reduction (referred to as a 5-D process) in numbers of the pertinent
microorganism, defined as "the most resistant microorganism of public health
significance that is likely to occur in the juice." Although thermal treatments are
most commonly used to ensure the required 5-D reduction, other processes will
be accepted if appropriately validated. FDA issued a Juice Hazards and Control
Guidance Document that provides some background on validating these alternate
treatments, which was complemented with an educational program developed by
the Juice HACCP Alliance.
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Processors of raw citrus juices are allowed to use surface decontamination
methods to achieve part of the 5-D pathogen reduction requirement under circum-
stances specified in the rule. The publication by FDA of information explain-
ing the scientific justification of the sampling plans for citrus juices that rely
on surface treatments to achieve a 5-D pathogen reduction is an excellent
example of using data and expert opinion to develop criteria or standards;
the committee believes that this derivation could be used as a model when
regulatory agencies develop other criteria or standards. In contrast, the justi-
fication for a 5-D pathogen reduction process for citrus juices is described in a
memorandum, with no reference to the scientific data from which the standard
derives. As mentioned earlier, transparency of the criteria development process
requires that the data and the assumptions made be clearly communicated.
The committee concludes that it would be premature to try to evaluate the
public health impact of the new juice regulations. However, the fact that no
disease outbreaks attributable to Salmonella or E. cold 0157:H7 in juices have
been reported to the Centers for Disease Control and Prevention since the juice
regulation was implemented is noteworthy.
Control of Patulin in Fruit Juices
The committee concludes that the action level established by FDA for patulin
in apple juice, apple juice concentrates, and apple juice products, 50 ,ug/kg
(50 ppm), is appropriate. This level can readily be achieved with proper adher-
ence to GMPs.
Criteria for Low-Acid and Acidified Canned Foods
For low-acid canned foods, a 12-D pathogen reduction thermal process must
be applied. This regulation includes other foods besides vegetables. For acidified
low-acid foods, defined as having a pH of 4.6 or below after equilibration, the
key control parameter is the acidification step rather than the thermal process.
Acidification of the food must be adequate so that the pH will not permit the
growth of microorganisms of public health significance. Other requirements for
these foods include standardized training of retort operators, registration of the
canning facility at state and federal levels, filing of thermal processes, record
keeping, and establishment of a recall program.
The committee recognizes that a clear example of the success of a per-
formance standard is illustrated by the fact that after the establishment of
the low-acid and acidified canned food rules and GMP regulations in the
1970s, only occasional cases of botulism attributable to these foods have
occurred. The committee also believes that the 12-D performance standard
for low-acid canned food might be too stringent and thus might compromise
some quality attributes of certain canned foods; therefore, it should be
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269
reevaluated. The committee is aware that technological innovation based on
nonthermal food-processing technologies is critical to the development of new
fruit and vegetable products. However, the committee reiterates its recommen-
dation that, prior to developing performance standards that accommodate
process or other technical innovations, guidance must be provided to indus-
try on process validation.
Criteria for Sprouts
As a result of several disease outbreaks associated with the consumption of
sprouts, FDA published the document Guidance to Industry Reducing Micro-
bial Food Safety Hazards for Sprouted Seeds, which recommends specific mea-
sures that sprout producers should apply to minimize pathogen contamination
and growth during sprout production. The committee recognizes that proper
application of this guidance enhances the safety of sprouts, but that it would
be premature to assess the effectiveness of the guidance. Nevertheless, the
committee notes that all sprout outbreaks reported since the publication of
the FDA guidelines have been associated with seed that was sanitized using
methods other than those described in the guideline.
Pesticide Residues
The committee believes that the process used to establish pesticide toler-
ances in produce is a good approach to ensure public health. The process of
setting pesticide tolerances by the U.S. Environmental Protection Agency is
in agreement with the committee's belief that food safety standards should
be developed based on a combination of the best available science and expert
opinion, and that this process should be a transparent one.
Safety Criteria for Dairy Products
Anecdotal observations that linked consumption of milk with the spread of
disease spurred various scientists and physicians in the United States and around
the world to undertake research to investigate the role of milk consumption in
foodborne disease as early as the turn of the twentieth century. Consumption of
unpasteurized milk was found to be associated with many serious diseases, includ-
ing diphtheria, typhoid, tuberculosis, and brucellosis. Early reports provided
evidence suggesting that control of milk-borne diseases required application of
sanitation measures at all points in the food system, from the farm to the con-
sumer. These observations also highlighted the need for technical research to
determine the bacterial destruction characteristics of food-processing treatments
for pathogenic microbes likely to be present in raw milk. The results of these
studies led to pasteurization and other intervention strategies designed to protect
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the public from exposure to hazardous microorganisms that may be present in
raw milk.
The Approach to Milk and Other Dairy Products Safety
Criteria for the safety of milk and other dairy products are defined in the
"Grade A Pasteurized Milk Ordinance," commonly referred to as the PMO. The
PMO is considered the reference for federal specifications for the procurement of
milk and dairy products and as the sanitary regulation for dairy products served
by carriers during interstate travel. It is also recognized by public health agencies
and the dairy industry as the national standard for milk sanitation. This ordinance
is administered by the National Conference on Interstate Milk Shipments and the
Cooperative State Public Health Service Program for certification of interstate
milk shippers, with FDA having oversight responsibility. Currently, all states, the
District of Columbia, and the United States trust territories participate in the
National Conference.
The committee recognizes that development, implementation, and
enforcement of the PMO has been directly credited with reducing the inci-
dence of milk-borne disease, and that the PMO is a good model for an
integrated strategy for product safety assurance. In addition, this model also
provides a specific structure and mechanism for biennial review of existing
regulations directed toward the fluid milk industry. Nevertheless, the com-
mittee notes that milk for local consumption is not subject to FDA oversight.
Therefore, consumption of unpasteurized (raw) milk continues to be an issue of
concern. The committee concludes that targeted educational programs that illus-
trate the hazards of raw milk and raw milk-product consumption for milk producers
and for the general public are warranted.
Through evolution of the PMO and other dairy standards, the dairy industry
has a long history of application of regulations to ensure the safety of its products
intended for interstate commerce. Nevertheless, the National Conference has
proposed its own testing of HACCP as an alternative to the traditional dairy
inspection/rating/check system. The committee concludes that one of the greatest
challenges facing the dairy industry is the incorporation of HACCP into the
regulatory format already in place, and commends the dairy industry for volun-
tarily implementing a HACCP pilot program. In addition, the committee strongly
encourages the timely adoption of HACCP systems throughout various sectors of
the dairy processing industry. Adoption of performance standards for pathogen
reduction, such as that proposed for cheese manufacturing, would more appropri-
ately fit into a HACCP framework than in the dairy industry' s current regulatory
system.
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Criteria for Control of Hazards in Milk and Milk Products
271
In addition to specific recommendations for pasteurization conditions speci-
fied in the PMO, chemical, bacteriological, and temperature standards have been
established for grade A raw milk products intended for pasteurization, as well as
for grade A pasteurized and bulk-shipped, heat-treated milk products. Concern-
ing the strict process requirements for milk pasteurization, the committee reiter-
ates its belief that implementation of performance standards that specify the
reduction in numbers required for a targeted organism in a food product, rather
than specifying the precise conditions for achieving that end (as currently
practiced), could allow greater flexibility and innovation in the dairy industry,
perhaps enabling the adoption of effective new processing technologies.
Despite the success of pasteurization in ensuring milk safety, the committee
notes that, in addition to incomplete destruction of spore-forming bacteria,
the efficacy of pasteurization in destroying other highly heat-resistant
microbes that may be present in raw milk, such as Mycobacterium avium
subspp. Paratuberculosis, requires FDA attention. Recent illness outbreaks
linked to dairy foods that had been successfully pasteurized, but then subjected to
postpasteurization contamination with bacteria such as Listeria monocytogenes
or Salmonella, highlight the critical need for application of effective processing-
plant sanitation programs to prevent postprocessing contamination of these products.
Somatic cell count limits for raw milk intended for pasteurized products are
arguably a safety standard, as exceeding these limits may prevent effective appli-
cation of a pasteurizing process. Similarly, the microbial standards for pasteur-
ized fluid milk products total bacteria and coliform bacteria are considered a
reflection of good management. The committee notes that despite the clear link
that has been established between raw milk consumption and foodborne illnesses,
some consumers continue to drink raw milk.
.
To further decrease the association between dairy products and food-
borne illnesses, the committee recommends that FDA and public
health agencies target educational programs to communicate to
consumers that drinking raw milk represents a form of risky food-
consumption behavior.
· In addition, state and local health authorities should ban the sale of
unpasteurized milk.
Criteria for Control of Hazards in Cheese
Current regulations state that no milk or milk products in final package form
intended for direct human consumption shall enter interstate commerce unless
they are manufactured from pasteurized milk or pasteurized milk ingredients,
except where alternative procedures are provided for by regulation. Moreover,
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standards of identity have been established for most natural cheeses, process
cheeses, cheese foods, and cheese spreads.
The committee examined the requirement that cheese made from unpasteur-
ized milk be cured for a period of 60 days at a temperature not less than 35°F, and
concludes that the scientific basis for this requirement is unclear.
.
The committee recommends the development and implementation of
a scientifically appropriate performance standard for the reduction
of targeted pathogens in finished cheese products that result from the
processing strategies or aging periods employed in the manufacture
of the products.
The cheese industry and FDA should work together to conduct or sponsor
research to assess pathogen reduction efficacies of cheese manufacturing condi-
tions.
The use of pasteurized milk in cheese manufacturing may provide an appro-
priate safe harbor for the manufacture of products for which adequate pathogen
reduction may not occur during manufacture or a holding period without an
additional intervention.
· In the meantime, to enable consumers to make informed decisions
regarding consumption of unpasteurized milk products, the com-
mittee recommends that FDA and state authorities require cheeses
manufactured from subpasteurized milk to be clearly and promi-
nently labeled as such at the point of purchase.
Representative terms from entire chapter:
safety criteria
