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USDA/FSIS Backgrounder
January 1995
FSIS Pathogen Reduction/HACCP Proposal
The Food Safety and Inspection Service (FSIS) is pursuing a
broad, long term science-based strategy to improve the safety
of meat and poultry products and better protect public health.
The strategy will address food safety issues from the farm to
the table, including proposed requirements for all federally
inspected meat and poultry plants to reduce pathogenic
microorganisms that can cause foodborne illness. The strategy
is based on the philosophy of prevention embodied in HACCP
(Hazard Analysis and Critical Control Points), a science-based
system for producing safe food.
The regulatory proposal would (1) target pathogens that cause
foodborne illness; (2) strengthen industry responsibility to
produce safe food; and (3) focus inspection and plant
activities on prevention objectives.
The proposal addresses three major areas:
Near-term initiatives
FSIS is proposing that:
- All plants develop and use written standard operating
procedures covering plant sanitation.
- Slaughter plants use at least one antimicrobial treatment
on all carcasses.
- All finished carcasses and parts be chilled promptly after
slaughter and be kept cool.
These requirements would have to be implemented within 90 days
from the date of publication of the final rule and would
remain in effect at least until a Hazard Analysis and Critical
Control Points (HACCP) system is implemented.
Proposed Interim Targets for Pathogen
Reduction and Microbial Testing
Under the proposal, FSIS would establish interim targets for
pathogen reduction and require daily microbial testing in
slaughter plants to determine whether targets are being met or
remedial measures are necessary. Raw products would be tested
for Salmonella, a representative pathogen, and establishments
would be required to achieve targeted reductions in the
incidence of Salmonella in relation to the current national
baseline incidence. Microbiological testing would be required
to begin in 90 days and tracking of test results would begin
6 months after the final rule is published. Compliance with
the interim targets would be determined by using a moving sum
statistical procedure that focuses on a specific number of
days within a production process.
Hazard Analysis and Critical
Control Points (HACCP)
All plants would be required to develop, adopt, and implement
Hazard Analysis and Critical Control Points (HACCP), a system
of preventive controls designed to improve the safety of
products. HACCP would be implemented during the three years
following the publication of the final rule. FSIS expects the
near-term initiatives and microbial testing requirements to
provide the foundation for the later adoption of HACCP by
plants.
Implementation Costs
FSIS estimates the total implementation cost of its proposed
requirements to the meat and poultry industry at $733.5
million, or an average of $244.5 million per year. Yearly
public health benefits from reduced foodborne illness costs,
including medical care and lost work time, would range from
$990 million to $3.7 billion. The increased cost to consumers
is estimated at slightly more than two tenths of a cent per
pound.
Comments
Comments on the proposal should be submitted to Diane Moore,
Docket Clerk, Room 3171 South Building, Food Safety and
Inspection Service, U.S. Department of Agriculture, Washington
DC 20250.
BACKGROUND
Current FSIS regulatory requirements and inspection procedures
contribute to the FSIS mission of ensuring that meat and
poultry products are safe, wholesome, and accurately labeled.
More than 7,400 FSIS inspectors are present in 6,200 slaughter
and processing plants to ensure that diseased animals and
birds do not enter the food supply and that sanitation and
other requirements are met. Inspectors also monitor the meat
and poultry supply for violative levels of chemical residues.
Despite the successes of the current program, there is a
critical gap in its ability to protect public health. The
current system largely focuses on organoleptic (sensory)
inspection, which was appropriate when the first major meat
inspection law was passed in 1906. At that time, animal
diseases were the major concern, and invisible hazards such as
pathogenic microorganisms and drug residues had not yet
attracted the attention of regulatory agencies. Since that
time, changes have been made in the inspection program to
reflect changes in the production of meat and poultry and to
increase the efficiency of inspection. However, the current
program still is inadequate to detect hazards such as
pathogenic microorganisms that can cause foodborne illness.
In short, it does not include integration of systematic
process control into the production process to make meat and
poultry as safe as possible.
While precise data on the incidence of illness associated with
meat and poultry products is limited, it is clear that
foodborne illness is a public health problem in the United
States. Data from varied sources suggest that foodborne
pathogens account for up to 7 million cases of foodborne
illness each year, and up to 7,000 deaths. Of these, nearly
5 million cases of illness and more than 4,000 deaths may be
associated with meat and poultry products.
Microbiological surveys of meat and poultry products conducted
over the past several decades show the frequency of pathogenic
microorganisms in cooked, ready-to-eat meat and poultry
products to be relatively low. The frequency of pathogenic
microorganisms in raw products has been greater and varies
from pathogen to pathogen and from species to species.
Even when the incidence of contamination is relatively low,
the public health threat can be serious. An example is the
outbreak of foodborne illness that occurred in several western
states in early 1993. The outbreak was attributed to
undercooked hamburgers contaminated with E. coli 0157:H7 that
were served at a chain of fast food restaurants. A study by
FSIS completed in 1990 found the prevalence of E. coli 0157:H7
in raw beef to be only 0.1 percent. Nevertheless, this
particular outbreak led to hundreds of cases of illness and
four deaths. Although the Department of Agricultures review
of the outbreak revealed that the incident was not caused by
a failure in the current inspection system, it concluded that
the system as it exists is deficient because it does not
adequately address the risk of microbial contamination.
This conclusion has been supported by many external studies
conducted during the past decade. The National Academy of
Sciences, the General Accounting Office, the National Advisory
Committee on Microbiological Criteria for Foods, industry,
producers and consumer groups have called for change in the
current inspection system to better address microbial
pathogens and make it more prevention-oriented.
THE PROPOSAL
Near-Term Initiatives
- Sanitation Standard Operating Procedures (SOPs)
Insanitary conditions during the production of meat and
poultry products increase the likelihood that pathogenic
bacteria will contaminate the finished product. At the same
time, poor sanitation is the most frequently observed problem
in meat and poultry plants.
FSIS is proposing to require all plants to establish written
SOPs for sanitation and maintain a system of records to
document adherence to the procedures. The proposal does not
change existing basic sanitation requirements found in the
regulations or guidance contained in the FSIS Sanitation
Handbook. Rather, the written sanitation SOPs would describe
the specific activities plant management has determined are
necessary to maintain good sanitation in a specific plant.
Examples of specific practices that might be included in an
SOP include pre-operational microbiological testing,
disinfection of equipment prior to start up, proper hand
washing between each carcass during skinning and evisceration,
and cleaning cattle prior to slaughter.
Sanitation SOPs are intended to clarify that sanitation is
industrys responsibility. They would make it easier for FSIS
inspectors to perform their proper role of verifying that
plant management is carrying out its sanitation
responsibilities.
- Antimicrobial treatments
The proposed regulation would require that slaughtering plants
apply at least one antimicrobial treatment to livestock and
poultry carcasses before chilling or cooling. FSIS recognizes
that this is not a complete solution to the problem of
pathogenic microorganisms but, rather, is one part of a
strategy to reduce pathogens.
For the purposes of this regulation, FSIS would approve
specific antimicrobial treatments when data are available
demonstrating that they are safe and effective and do not
adulterate the product. The following are available
antimicrobial treatments that FSIS tentatively concludes could
satisfy its proposed requirements for a mandatory
antimicrobial treatment: hot water; lactic, acetic, and citric
acid solution sprays; trisodium phosphate; and chlorinated
water. The Agency encourages the development of new
antimicrobial procedures and will work with those who have
developed and want to evaluate processing techniques designed
to enhance product safety.
Antimicrobial treatments will not be allowed to substitute for
careful sanitary dressing procedures. This new proposed
requirement would not change the current FSIS policy regarding
removal of physical contaminants from meat and poultry
carcasses. The proposal clarifies that there is no tolerance
for feces on poultry carcasses.
- Time/Temperature Controls
Rapidly cooling carcasses is one means of preventing the
multiplication of pathogenic bacteria. FSIS is proposing that
appropriate time/temperature controls for handling raw
products, which many plants follow voluntarily based on
prevailing industry standards, become mandatory.
Plants would be required to cool the surface of meat carcasses
to 50x F or below within 5 hours and to 40x F or below within
24 hours from the time that carcasses exit the slaughter
floor. In addition, carcasses and meat products would be
required to be maintained at 40x F or below during handling,
holding, and shipping.
Current poultry regulations already require that all poultry
slaughtered and eviscerated be chilled immediately after
processing so that the internal temperature is reduced to 40x
F or below within a time period appropriate for the size of
the carcass. Eviscerated poultry to be shipped must be
maintained at 40x F or below, with certain exceptions. FSIS
is proposing to amend the poultry regulations to include
provisions for alternative time/temperature requirements, to
mandate corrective actions when time/temperature controls
fail, and to eliminate other provisions inconsistent with
those being proposed for meat.
The proposed time/temperature cooling requirements for meat
are equivalent to those in effect and being proposed for
poultry in terms of their public health benefits and are
readily attainable under current commercial conditions.
Plants would be required to develop, implement, and file a
written plan for meeting the time and temperature
requirements. Inspection personnel would verify that the
written plan is being followed and would measure temperatures
at various control points and compare them with those measured
and recorded by the plant.
Products that are not chilled quickly enough, or that have
been held at temperatures exceeding 40x F, would be required
to be further processed to kill pathogens or be condemned.
Interim Targets for Pathogen Reduction and Microbial Testing
FSIS believes that the production of raw meat and poultry with
an incidence of Salmonella below the current national
incidence level is readily achievable with available
technology and production methods. FSIS is proposing that all
plants should be required to control their processes to
achieve microbial targets below the national incidence level,
and is therefore proposing interim targets for pathogen
reduction in slaughter plants.
Under the proposal, plants would be required to sample and
test representative products daily for the presence of
Salmonella. FSIS would identify a national baseline incidence
of Salmonella contamination for each major species and for
ground meat and poultry. FSIS is proposing that within two
years following the publication of the final rule, or within
some other period specified by FSIS, all plants reduce
contamination below the baseline, perhaps by some specified
percentage. FSIS is interested in comments on what that
percentage should be.
This is an initial step toward measurable reductions in
microbial contamination and a first step toward the eventual
incorporation of microbial testing as an integral part of
process control and verification in plants operating under the
HACCP approach. FSIS intends to work toward setting more
definitive targets, guidelines, or standards, including the
possible identification of levels of specific pathogens that
pose a safety concern and the use of those levels for
regulatory purposes. Even as the scientific basis for such
standards develops, however, FSIS believes that significant
reductions in the risk of foodborne illness can be achieved by
requiring compliance with interim targets for pathogen
reduction.
Salmonella was selected as the target pathogen because it is
the leading cause of foodborne illness, it is present on
virtually all raw food products, and it can easily be
recovered from a variety of products. Reductions in
Salmonella should also result in reductions of other human
pathogens.
Each plant would be required to develop a written protocol,
available for review by the inspector in charge, outlining
specimen collection and handling. The results would be entered
into a moving sum process control table or chart, which
provides immediate feedback on the effectiveness of the
control system.
Plants that are not achieving the established targets for
pathogen reduction within the period specified by FSIS would
be required to take corrective action under FSIS supervision
to improve process control to achieve the target.
Hazard Analysis and Critical Control Points (HACCP) Systems
FSIS is proposing that federally inspected meat and poultry
plants adopt HACCP systems to provide documentation that their
processes are in control and producing safe products. The
HACCP approach is a preventive system of process control that
is widely recognized by scientific authorities and
international organizations and is used in the food industry
to produce product in compliance with health and safety
requirements.
Implementation of HACCP would clarify that the industry, not
the inspection service, is responsible for producing safe meat
and poultry products. With HACCP in place, FSIS would verify
that the plant is controlling its processes and consistently
producing products that comply with food safety requirements.
HACCP systems would cover those critical control points
(CCPs) that affect product safety, as opposed to those
related to economic adulteration and quality. A HACCP plan
would be required for each type of processing activity carried
out by the plant. FSIS would not approve HACCP plans in
advance but would evaluate their effectiveness as part of the
inspection process.
Plants would be required to develop HACCP plans based on the
seven principles articulated by the National Advisory
Committee on Microbiological Criteria for Foods:
(1) Conduct a hazard analysis;
(2) Identify the CCPs in the process;
(3) Establish critical limits for preventive measures
associated with each identified CCP;
(4) Establish CCP monitoring requirements;
(5) Establish corrective action;
(6) Establish effective recordkeeping procedures; and
(7) Establish procedures for verifying that the HACCP
system is working correctly.
Implementation would be phased in, based on the type of
production process. It is proposed that implementation for
processes associated with the greatest public health risk
would begin 12 months after publication of the final rule.
Implementation would be complete 36 months after publication
of the final rule. Small establishments, which FSIS is
proposing to define as those with an annual production valued
at or below $2.5 million, would be permitted 36 months from
the date of publication of the final rule to start their HACCP
plans, regardless of the processes they carry out.
Food Safety from Farm to Table
The proposed regulations address product safety only within
the plant environment. The Agency recognizes that ensuring
food safety requires taking steps throughout the chain of
production, processing, distribution, and sale to prevent
hazards and reduce the risk of foodborne illness. To minimize
the growth of pathogens once a product leaves the plant, FSIS
is announcing its intent to initiate rulemaking with the Food
and Drug Administration (FDA) to establish Federal standards
for the safe transportation of foods. FSIS will also work
with FDA to ensure food safety at the retail level by
encouraging States to adopt and enforce consistent, science-
based standards.
Although animal production food safety is not the subject of
this regulatory proposal, FSIS also will work with animal
producers and others to develop and implement food safety
measures that can be taken on the farm and before animals
enter the slaughter facility to reduce the risk of harmful
contamination of meat and poultry products.
In addition, the Agency will continue its comprehensive food
handler education programs to inform the public and those who
prepare and serve food to the public on how to properly
handle, prepare, and store meat and poultry products to
minimize the growth of foodborne pathogens.
Health-Based Standards for Pathogenic Microorganisms
The proposed requirement that plants achieve a certain
reduction in the incidence of Salmonella is an initial step
toward articulating an acceptable level of food safety
performance. The broader task of identifying levels of
specific pathogens that pose a threat to public health is
complex. FSIS intends to hold one or more public meetings to
explore this and other topics with interested parties and
intends to work closely with government and public health
agencies, academia, industry, and consumer groups to develop
the scientific basis for microbial risk assessment and health-
based performance standards for pathogenic microorganisms.
Technology Development
Because the development and proper use of technology can
contribute significantly to improving the safety of the food
supply, FSIS is encouraging technology development in several
ways. First, by setting public health standards, the Agency
believes it is providing a heightened incentive to take
innovative steps to improve food safety. Second, FSIS will
review its policies and procedures governing the review and
approval of in-plant technologies to simplify them as much as
possible, while ensuring that safety and efficacy are not
compromised. Third, FSIS will focus its own limited
technology development resources on tools that can assist the
Agency in detecting and evaluating food safety hazards and on
research that requires a long-term commitment.
FSIS Inspection Roles
FSIS must consider the future roles of its inspection force.
FSIS intends to work closely with the bargaining unit and
employee organizations in formulating its plan for inspection
under HACCP. FSIS must consider a number of issues, including
(1) what additional tasks FSIS inspectors should be
performing under HACCP,
(2) what the role of FSIS inspectors should be in ensuring
that Federal standards are met during transportation and
at the retail level, and
(3) what new inspection tools and techniques are needed in a
regulatory environment where greater responsibility for
safety is being placed on industry.
Administration Food Safety Initiatives
These initiatives build on a number of important steps already
undertaken by the Administration to strengthen and update the
Federal inspection program for meat and poultry products.
They include:
(1) the elevation of food safety to a sub-Cabinet-level
responsibility within the Department of Agriculture,
(2) development of pathogen reduction legislation to target
microbial pathogens in meat and poultry products and
reduce the risks of foodborne illness,
(3) declaration of E. coli 0157:H7 in raw ground beef to be
an illegal adulterant and initiation of a sampling
program for raw ground beef,
(4) streamlined approval of antimicrobial treatments to help
the beef industry move faster to install new technologies
to reduce pathogens;
(5) initiation of unannounced reviews in 1,000 meat and
poultry plants to enforce inspection requirements,
(6) implementation of mandatory safe handling instructions on
labels of meat and poultry products, and
(7) increased funding for food safety research.
To obtain paper or diskette copies of the proposal contact:
National Technical Information Service (NTIS)
U. S. Department of Commerce
5285 Port Royal Road
Springfield, VA 22161
(Reference NTIS accession number PB95-166021 for a paper copy
and PB95-502217 for the diskette version).
For telephone orders or further information on placing an order,
call NTIS
at (703) 487-4650 for regular service or (800) 533-NTIS for rush
service.
To order the proposal electronically and download via FedWorld,
dial (703) 321-8020
with a modem or Telnet fedworld.gov. For technical assistance to
access FedWorld, call (703) 487-4608.
For more information
Technical Inquiries: (202) 720-7773
Media Inquiries: (202) 720-9113
Congressional Inquiries: (202) 720-3897
Constituent Inquiries: (202) 720-7943
Consumer Inquiries:
Call USDA's Meat and Poultry Hotline at: 1-800-535-4555
In the Washington, D.C. area, call: (202) 720-3333
U.S. Department of Agriculture
Food Safety & Inspection Service
Backgrounder: January 1995