[Federal Register Volume 60, Number 23 (Friday, February 3, 1995)]
[Proposed Rules]
[Pages 6774-6889]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-2366]
[[Page 6773]]
_______________________________________________________________________
Part II
Department of Agriculture
_______________________________________________________________________
Food Safety and Inspection Service
_______________________________________________________________________
9 CFR Part 308, et al.
Pathogen Reduction; Hazard Analysis and Critical Control Point (HACCP)
Systems; Proposed Rule
Federal Register / Vol. 60, No. 23 / Friday, February 3, 1995 /
Proposed Rules
[[Page 6774]]
DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
9 CFR Parts 308, 310, 318, 320, 325, 326, 327, and 381
[Docket No. 93-016P]
RIN 0583-AB69
Pathogen Reduction; Hazard Analysis and Critical Control Point
(HACCP) Systems
AGENCY: Food Safety and Inspection Service, USDA.
ACTION: Proposed rule.
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SUMMARY: The Food Safety and Inspection Service (FSIS) is proposing
requirements applicable to all FSIS-inspected meat and poultry
establishments that are designed to reduce the occurrence and numbers
of pathogenic microorganisms in meat and poultry products and to reduce
the incidence of foodborne illness associated with the consumption of
those products. The proposals would (1) clarify the responsibility of
establishment management to ensure compliance with sanitation
requirements; (2) require at least one antimicrobial treatment during
the slaughter process prior to chilling of the carcass; (3) establish
enforceable requirements for prompt chilling of carcasses and parts;
(4) establish interim targets for pathogen reduction and mandate daily
microbial testing in slaughter establishments to determine whether
targets are being met or remedial measures are necessary; and (5)
require that all meat and poultry establishments develop, adopt, and
implement a system of preventive controls designed to improve the
safety of their products, known as HACCP (Hazard Analysis and Critical
Control Points). FSIS is also announcing its intent to initiate
rulemaking jointly with the Food and Drug Administration (FDA) to
establish Federal standards for the safe handling of food during
transportation, distribution, and storage of the products prior to
delivery to retail stores, as well as further efforts to encourage
adoption and enforcement by States of consistent, science-based
standards to ensure food safety at the retail level. These proposals
and initiatives are part of a comprehensive strategy to improve the
safety of meat and poultry products when they are delivered to the
consumer.
DATES: Comments must be received on or before June 5, 1995.
ADDRESSES: Submit written comments in triplicate to Diane Moore, Docket
Clerk, Room 3171 South Building, Food Safety and Inspection Service,
U.S. Department of Agriculture, Washington, DC 20250. Oral comments, as
permitted under the Poultry Products Inspection Act, should be directed
to the appropriate person listed under FOR FURTHER INFORMATION CONTACT.
FOR FURTHER INFORMATION CONTACT: (1) GENERAL: Dr. Judith A. Segal,
Director, Policy, Evaluation, and Planning Staff, (202) 720-7773; (2)
SANITATION: Dr. Isabel Arrington, Staff Officer, Inspection Management
Program, Inspection Operations, (202) 720-7905; (3) ANTIMICROBIAL
TREATMENTS: Dr. William O. James, II, Director, Slaughter Inspection
Standards and Procedures Division, Science and Technology, (202) 720-
3219; (4) TEMPERATURE CONTROLS: Carl S. Custer, Staff Officer,
Processed Products Inspection Division, Science and Technology, (202)
501-7321; (5) MICROBIAL TESTING: Dr. Richard A. Carnevale, Assistant
Deputy Administrator, Scientific Support, Science and Technology, (202)
205-0675; (6) HACCP: Dr. Dorothy Stringfellow, Director, HACCP Office,
Science and Technology, (202) 690-2087; (7) TRANSPORTATION AND RETAIL:
Patrick J. Clerkin, Director, Evaluation and Enforcement Division,
Compliance Program, Regulatory Programs, (202) 254-2537, Food Safety
and Inspection Service, U.S. Department of Agriculture, Washington, DC
20250.
OBTAINING COPIES OF THIS DOCUMENT: Paper or diskette copies of this
document may be ordered from the National Technical Information Service
(NTIS), U.S. Department of Commerce, 5285 Port Royal Road, Springfield,
VA 22161. Orders must 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
access this document electronically for ordering and downloading via
FedWorld, dial (703) 321-8020 with a modem or Telnet fedworld.gov. For
technical assistance to access FedWorld, call (703) 487-4608.
Supplementary Information:
Table of Contents
I. Background
Purpose of this Document
Origins and History of the FSIS Program
Foodborne Illness in the United States
Consumer Knowledge and Behavior
External Studies and Recommendations for Change
FSIS Agenda for Change
FSIS Food Safety Goal
FSIS Food Safety Regulatory Strategy
II. Discussion of Regulatory Proposals
Overview
A. Transition to HACCP
Sanitation Standard Operating Procedures
Antimicrobial Treatments
Temperature Controls
B. Microbial Testing; Interim Targets
Current Testing Program
Proposed Interim Targets and Testing
C. Hazard Analysis and Critical Control Point Systems
Background
Discussion of HACCP Proposal
Illustrations of HACCP Applications
D. Effective Dates
III. Other Issues and Initiatives
A. Legal Authority
B. Improving Food Safety at the Animal Production Stage
C. Transportation, Distribution, Storage, Retail
D. Health-Based Standards for Pathogenic Microorganisms
E. FSIS Technology Strategy
F. FSIS Inspectional Roles
IV. Economic Impact Analysis and Executive Orders
V. References
VI. Proposed Rules
VII. Appendix--Generic HACCP for Raw Beef
VIII. Supplement--Preliminary Regulatory Impact Assessment
I. Background
Purpose of This Document
The mission of the Food Safety and Inspection Service (FSIS) is to
ensure that meat and poultry products are safe, wholesome, and
accurately labeled. Current FSIS regulatory requirements and inspection
procedures contribute much to the achievement of these goals, but there
is a critical gap in the FSIS program. The current program does not
directly target pathogenic microorganisms, which frequently contaminate
otherwise wholesome carcasses. It also does not make meat and poultry
establishments legally responsible for taking systematic, preventive
measures to reduce or eliminate the presence of pathogenic
microorganisms in meat and poultry products. This gap in the FSIS
program has important public health implications because a significant
portion of the cases of foodborne illness in the United States is
associated with the consumption of meat and poultry products that are
contaminated with pathogenic microorganisms.
To protect public health and reduce the risk of foodborne illness,
FSIS proposes to fill the gap in its current system by requiring new
measures that will target and reduce the presence of pathogenic
microorganisms in meat and poultry products. FSIS is also beginning a
fundamental shift in the paradigm governing its inspection program.
FSIS [[Page 6775]] will begin to build the principle of prevention into
its inspection program by requiring all meat and poultry establishments
to adopt the Hazard Analysis and Critical Control Point (HACCP)
approach to producing safe meat and poultry products. FSIS will also
take steps to encourage preventive measures on the farm, require
preventive controls during transportation, and support State-based
HACCP controls at retail.
The purpose of this document is to initiate the rulemaking required
to bring about these changes in the FSIS program. This document will
also explain these changes in the context of a broad and long-term
strategy to improve the safety of meat and poultry products. The safety
of any food product can be affected--positively or negatively--at
virtually every step in the process of producing the agricultural
commodity on the farm, converting the agricultural commodity into a
food product through slaughter and other processing, distributing the
product to the consumer, and preparing the product for consumption.
While this document focuses on changes that are needed within FSIS-
inspected establishments, these changes are part of a broader food
safety strategy. This strategy addresses each step in the process and
takes a long-term approach to building a comprehensive food safety
system that works effectively to protect consumers by preventing food
safety problems.
To place the regulatory program in context, this document will
first describe the origins and history of the FSIS program, the problem
of foodborne illness in the United States, and FSIS's food safety
objectives and proposed strategy for achieving them.
Origins and History of the FSIS Program
The following historical account briefly describes the purposes and
operation of the inspection program from its late-nineteenth century
inception through the current efforts to improve the program.
1890-1945
Federal meat inspection legislation dates from 1890, when countries
in Europe raised questions about the safety of American beef. Congress
gave the U.S. Department of Agriculture (USDA) responsibility for
ensuring that exports would meet European requirements and, in 1891,
for conducting ante- and postmortem inspection of livestock slaughtered
for meat intended for distribution in the United States.
In 1906, the graphic picture of insanitary conditions in meat-
packing establishments described in Upton Sinclair's novel The Jungle
outraged the U.S. public. Congress responded by passing the Federal
Meat Inspection Act (FMIA), one of the first Federal consumer
protection measures. It established sanitary standards for slaughter
and processing establishments, and mandated antemortem inspection of
animals (cattle, hogs, sheep, and goats) and postmortem inspection of
every carcass.
It also required the continuous presence of Government inspectors
in all establishments that manufactured meat products for commerce.
Because the program depended heavily on veterinary skills, it was
implemented by USDA's Bureau of Animal Industry which, during that
first year, oversaw the inspection of nearly 50 million animals.
The companion Food and Drug Act of 1906 was implemented by a
different section of USDA, the Bureau of Chemistry. It covered the
safety of all food products except meat and poultry, but it did not
require continuous inspection. The Food and Drug Administration (FDA),
which now implements the law, was formed in USDA in 1930 and
transferred to the Public Health Service in 1940. Meat inspection,
which primarily focused on carcass inspection by veterinarians,
remained in USDA.
The meat inspection program that developed early in this century
used organoleptic methods, based on sight, touch, and smell. The major
public health concerns of the time were the potential for transmission
of diseases from sick animals to humans and the lack of sanitary
conditions for animal slaughter and production of processed products.
The purpose of carcass inspection was to keep meat from diseased
animals out of the food supply. Federal inspectors under the
supervision of veterinarians checked every live animal and every
carcass for signs of disease. They also watched for insanitary
practices and the use of dangerous preservatives.
In addition to requiring carcass-by-carcass inspection in slaughter
establishments, the 1906 meat inspection law provided for continuous
USDA inspection of processing operations. Processing, which for the
most part consisted of cutting and boning whole carcasses and the
production of sausages, ham, and bacon, was usually done in or near the
slaughterhouse. Processing was viewed as an extension of slaughter and
was conducted by the same FSIS personnel. From the inception of the
Program, however, the Agency recognized that, in processing inspection,
the inspector focused on the operation of the overall production line,
not on each production unit (in contrast to slaughter inspection, where
inspectors focused on each carcass).
The FMIA covered all meat and meat products in interstate commerce.
It did not cover poultry. At that time, chickens and turkeys were
produced mainly on small farms for personal consumption or sale in the
immediate area. They were inspected only by the purchaser.
1946-1975
Developments after World War II had a major impact on the meat and
poultry industry. New establishments opened, beginning a surge of
growth that continued through the 1950's and 1960's. The market for
dressed, ready-to-cook poultry expanded rapidly, and both the meat and
the poultry industries began turning out many new kinds of processed
products. An increasing proportion of the total meat and poultry supply
was being processed into hams, sausages, soups, frankfurters, frozen
dinners, pizza, and so forth. Between 1946 and 1976, the volume of such
products almost quadrupled.
New technology, new ingredients, and specialization added
complexity to the once-simple processing industry. Small
establishments, many producing solely for intrastate commerce, began
producing new products outside the slaughterhouse environment.
Processing inspection could no longer be managed as an extension of
slaughter inspection.
The growth of the processing sector presented the inspection
program with major challenges. First, the skills needed by the Agency
called increasingly on the disciplines of food technology and
microbiology, along with those of veterinary medicine. The Agency began
to recruit and develop more people with the specialized skills
necessary to design processing inspection systems.
Second, more inspectors were needed to meet the industry's growing
production and geographic expansion. A system of ``patrol'' inspection
assignments, with one inspector visiting several processing
establishments daily, was devised to fulfill the statutory requirement
for continuous inspection in those establishments.
Third, new technologies made it difficult for consumers to check
levels of fat, water, and other ingredients used as fillers, increasing
the risk of economic adulteration. As a result, USDA inspectors were
increasingly called on to protect consumers in this technically complex
area. Controlling the use of certain vegetable proteins as
[[Page 6776]] ingredients in meat food products, for example, became
important, because vegetable proteins can mask the addition of water to
a product. The development of equipment to salvage formerly discarded
high-protein tissue from bones and fatty tissue made time-temperature
requirements necessary to guard against the growth of spoilage
organisms. Standards had to be set for the use of these ingredients and
the labeling of products containing them.
Meanwhile, better animal husbandry practices had improved animal
health and reduced the public health risk from diseased carcasses. The
Agency's extensive, statutorily mandated carcass-by-carcass inspection
continued, however, with the important objective of eliminating from
commerce the unpalatable signs of disease (such as tumors and lesions),
meat from animals with diseases that could pose a human health risk
(such as salmonellosis or cysticercosis), fecal contamination of meat
and poultry carcasses, and visible damage (such as bruises).
Establishment sanitation also remained an important object of
inspection in both slaughter and processing facilities.
The Poultry Products Inspection Act (PPIA) of 1957 made inspection
mandatory for all poultry products intended for distribution in
interstate commerce. It was modeled after the Federal Meat Inspection
Act.
The potential for unseen health hazards in the food supply also
attracted increasing regulatory attention. In 1962, Rachel Carson's
Silent Spring raised public awareness of the possible harmful effects
of pesticides and other chemical contaminants in food. In 1967, the
Agency established the National Residue Program, the Federal
Government's principal regulatory mechanism for determining and
controlling the presence and level of those chemicals in meat and
poultry that may present a public health concern.
Because of the increasing volume and complexity of food production
and the potential for various forms of adulteration that consumers
could not, by themselves, determine, Congress enacted new legislation
during this period to assure the safety and wholesomeness of all foods,
including meat and poultry products. The 1958 Food Additives Amendment
of the Federal Food, Drug, and Cosmetic Act (FFDCA) provided for FDA
approval of new food additives and their conditions and levels of use.
The Wholesome Meat Act of 1967 and the Wholesome Poultry Products
Act of 1968 amended the basic laws governing mandatory meat and poultry
inspection to assure uniformity in the regulation of products shipped
in interstate, intrastate, and foreign commerce. These Acts provide the
statutory basis for the current meat and poultry inspection system.
Both Acts gave USDA new regulatory authority over allied industries,
including renderers, food brokers, animal food manufacturers, freezer
storage concerns, transporters, retailers, and other entities. Both
Acts incorporated adulteration and misbranding prohibitions tied to
important provisions of the FFDCA relating to food and color additives,
animal drugs, and pesticide chemicals. Both Acts provided stronger
enforcement tools to USDA, including withdrawal or refusal of
inspection services, detention, injunctions, and investigations. Both
Acts extended Federal standards to intrastate operations, provided for
State-Federal cooperative inspection programs, and required that State
inspection systems be ``at least equal to'' the Federal system.
Also, under these Acts, meat and poultry products from foreign
countries that are sold in the United States must have been inspected
under systems that are equivalent to that of USDA.
1970s-Present: Increasing Demand for Inspection
By the 1970s, the need to focus on ``invisible'' hazards to public
health had raised the ratio of analytical to organoleptic activities,
and the ratio of out-of-plant to in-plant activities. The bulk of the
Agency's resources continued to be allocated, however, to in-plant
activities addressing the issues of animal disease and establishment
sanitation. During the 1970s, national budget constraints reduced the
funds available for inspection throughout the United States. As
individual States exercised their right to request that the Agency take
over their inspection programs, FSIS had either to eliminate some
inspection activities or change the way they were performed, to provide
the additional coverage.
The driving force behind FSIS's program changes from the 1970s on
was the need to keep up with industry's expansion and its productivity
gains, including the incorporation of automation in the slaughter
process that increased the rate at which carcasses could move through
the slaughter facility (typically referred to as ``line speed'').
Automation has had a particularly great impact on poultry operations,
where inspectors have had to face faster and faster line speeds, which
today can be as high as 91 birds per minute.
The industry changed in many ways during this period. The poultry
industry became, to a large extent, vertically integrated, with large
companies controlling each step of the process from production of birds
to slaughter, processing, distribution, and marketing of chicken and
turkey products under brand names. The beef and pork industries grew,
but generally did not become vertically integrated. Beef cattle and
swine continued to be produced by a large number of independent farming
businesses. Consolidation occurred in slaughter and processing
operations, and production increased. Increased production meant more
meat and poultry products awaited inspection by FSIS inspectors.
The Agency strained to keep pace with an industry radically
different in scale and scope from what it had been in 1906. In
September 1976, the Agency hired the management consulting firm of
Booz, Allen and Hamilton, Inc., to perform an in-depth study to find
less costly ways to inspect meat and poultry that would not reduce the
level of consumer protection. The study recommended, among other
things, that FSIS:
Use quality control mechanisms to shift responsibilities
from inspectors to the establishment, giving inspectors a verification
responsibility.
Establish microbiological criteria for finished products.
Explore substitution of air chilling for water chilling of
poultry carcasses.
Require chlorination of chiller water for poultry.
Expand food safety education for consumers and food
handlers.
The study elicited a generally negative response from consumer
groups and some members of FSIS's workforce, who interpreted the
recommended role changes as an abdication of Agency responsibility.
Anticipating higher costs and concomitant price hikes, industry also
objected to the recommendations. FSIS decided to pursue only some of
the recommendations.
One that it did pursue in processing establishments, the voluntary
Total Quality Control (TQC) program, was implemented in 1980. The
General Accounting Office (GAO) had recommended a TQC-type program in
December 1977, to afford the Agency flexibility to tailor inspection
frequency to individual establishments' needs. This program applied a
different kind of inspection to establishments that FSIS approved for a
self-monitored production control program designed to assure that
processed products would meet regulatory requirements. In those
[[Page 6777]] establishments, the inspector, instead of personally
generating production process information, used establishment
production records on the production process, supplemented by in-plant
observations, to verify that product was in compliance. In many
establishments, TQC reduced the time needed for inspection, but the
statutory provision for ``continuous'' inspection meant that, even
under TQC, an inspector had to visit the establishment at least daily.
In 1978, the Agency issued its own report, ``A Strengthened Meat
and Poultry Inspection Program.'' Among other things, the report
observed that the poultry postmortem system had been designed before
both the vertical integration of the poultry industry and the
increasing attention to production control, which had helped producers
overcome major animal and poultry health problems. With the
introduction of high-speed production lines, the traditional inspection
system had become ``severely stressed,'' with inspectors ``forced to
work at speeds well over those at which peak effectiveness is
expected.'' Scientific evidence indicated that with the improvement in
animal health, little of the carcass examination performed by
inspectors was necessary to protect public health. However, carcass-by-
carcass inspection continued to address the wholesomeness and quality
aspects of meat and poultry that consumers demanded.
Between 1980 and 1986, the Agency introduced what became known as
streamlined inspection systems (SIS) in high-speed poultry slaughter
operations. These systems shifted routine tasks that controlled for
quality, rather than safety, from inspectors to establishment
employees. Since an increasing amount of the poultry (and meat) supply
was being produced under brand names, the Agency believed that
establishments would be motivated to protect the reputation of their
products by performing systematic quality control for visible,
unpalatable defects. Under streamlined inspection, establishment
employees, working under FSIS supervision, would perform detection and
trimming of carcass defects that affect the ``quality,'' but not the
``safety'' of the product--functions previously performed by FSIS
inspectors. The attempt to streamline carcass inspection by shifting
non-public health tasks to the industry was criticized by consumer
groups and inspectors, who interpreted the modernization initiative as
a pretext for deregulation.
In 1986, Congress granted the Agency the authority to vary the
frequency and intensity of inspection in processing establishments on
the basis of the risk presented by the particular establishment and
process. Again, FSIS's proposal to implement this authority was
interpreted by consumer groups as an effort to reduce inspection. They
opposed it, as did some Agency employees. Industry members supported
the concept but were skeptical about how it would be implemented. For
lack of support, the Agency withdrew its proposal, and the legislative
authority for it expired in 1992.
Each of the foregoing modernization initiatives aroused the same
concerns: Increased line speeds compromised job performance; new
procedures had not been adequately or objectively tested; and,
generally, streamlined slaughter inspection policies would not protect
consumers. While SIS for poultry survived, the controversy blocked
FSIS's attempt to extend SIS to cattle. A special review in 1990 by the
National Academy of Sciences (NAS) pointed out deficiencies in the
current system's handling of microbiological hazards but concluded that
a SIS for cattle would be at least as effective as traditional
inspection. However, consumers and the Agency's inspection workforce
equated SIS for cattle with deregulation--license for industry to
increase line speeds at the expense of public health. Congress ordered
the Agency to stop the pilot tests then in progress in five cattle
operations.
Today, FSIS inspectors perform hundreds of tasks during slaughter
and processing operations. Slaughter inspection occurs in two phases:
ante- and postmortem. During antemortem inspection, the inspectors
observe all red meat animals at rest and in motion, segregating any
abnormal animals they detect before the animals enter the slaughter
facility. Based on further examination by a Veterinary Medical Officer
(VMO), abnormal animals are either condemned or allowed to enter the
slaughter process under special handling.
Because the large number of chickens and turkeys FSIS inspects
(more than 6 billion slaughtered annually) makes antemortem bird-by-
bird inspection impracticable, inspectors or VMO's conduct the
antemortem inspection of poultry on a flock or lot basis. The poultry
are observed while in coops or grouped for slaughter, before or after
they are removed from trucks. Abnormal birds are condemned.
Antemortem inspection can detect some diseases (for example,
rabies, listeriosis, and heavy metal toxicosis) through distinct
clinical signs that cannot be detected by gross postmortem inspection.
Additionally, some types of microbial diseases that can seriously
contaminate the slaughter environment, such as abscesses and anthrax,
can be detected by antemortem inspection. In those cases, the affected
animals are prevented from entering the slaughterhouse.
During the postmortem phase of Federal inspection, the viscera and
carcasses of all animals and birds slaughtered are examined by an FSIS
inspector on the processing line. (See Figures 1 and 2 for illustrative
schematics of beef and broiler chicken slaughter.) Many of the bacteria
implicated in cases of foodborne illness live in the intestinal tracts
of meat animals and poultry, present no evidence of overt pathologies
in the animal, and can be shed in the feces. For this reason, line
inspectors require physical removal of visible fecal and ingesta
contamination of flesh.
For red meat, inspectors examine the heads, viscera, and carcass at
one or more postmortem inspection stations. For poultry the viscera,
carcasses, and, for older poultry, heads are examined at a single
postmortem inspection station. To detect abnormalities at these
stations, the red meat inspector performs a sequence of observations,
palpations, and incisions of tissues; the poultry inspector, a sequence
of observations and palpations. For both red meat and poultry, visible
contaminants (such as feces), damage, and other abnormalities are
detected and eliminated to ensure only meat and poultry that appear fit
for human consumption ``pass'' inspection. Only VMO's and VMO-
supervised inspectors make the final determination.
BILLING CODE 3410-DM-P
[[Page 6778]]
[GRAPHIC][TIFF OMITTED]TP03FE95.000
[[Page 6779]]
[GRAPHIC][TIFF OMITTED]TP03FE95.001
BILLING CODE 3410-DM-C
[[Page 6780]]
The prevention of ingesta and fecal contamination of beef and
poultry carcasses in slaughter establishments is a focal point of the
current inspection system, because contamination of the flesh with
feces and ingesta is a potential cause of contamination of meat and
poultry products with harmful bacterial pathogens, such as Salmonella,
Campylobacter and E. coli 0157:H7. Contamination can occur as a result
of feces entering the slaughter facility on the external surface of the
animal and contaminating the carcass during the skinning or
defeathering process or as a result of ingesta or feces being spilled
from the intestinal tract during evisceration or other steps in the
process. Meat and poultry carcasses found to bear fecal contamination
must be condemned or, if possible, reworked to remove the contamination
in an accepted manner. Removing visible fecal contamination is
important, but it does not assure the absence of harmful bacteria that
cannot be detected visually.
The law requires inspected meat and poultry products to bear an
official inspection legend (21 U.S.C. 601(n)(12), 453(h)(12)).
Specifically, the words ``inspected and passed'' must appear on meat
products found not to be adulterated (21 U.S.C. 606, 607; 9 CFR 312.2,
312.3); ``inspected for wholesomeness by U.S. Department of
Agriculture'' must appear on poultry products (9 CFR 381.96). The term
``wholesome'' has traditionally been applied to meat or poultry found
upon visual inspection to be free of disease, not decomposed, and to be
otherwise fit for human consumption. While ``wholesome'' as used in
this context is not intended to be synonymous with ``safe,'' consumers
could reasonably infer a connection between ``wholesomeness'' and food
safety. Similarly the words ``inspected and passed'' on meat products
could be understood by consumers as a statement about safety, despite
the fact that organoleptic inspection does not address invisible
hazards, such as pathogenic microorganisms.
This problem concerning the meaning of the inspection legend arises
in part from the fact that the requirement to place an inspection
legend on every product that passes inspection was adopted before the
safety concerns posed by pathogenic microorganisms, drug residues, and
other invisible hazards came to the fore. Visual inspection does not
directly address these safety issues on a carcass-by-carcass or
product-by-product basis. Thus, some contend that the inspection
legends serve only to mislead contemporary consumers and should be
discontinued. FSIS invites public comment on this issue.
Of the 129,831,110 meat-animal carcasses inspected during Fiscal
Year 1993, 384,543 (or .3 percent) were condemned for disease,
contamination, or adulteration during ante- or postmortem inspection.
Of the 7,085,491,852 poultry carcasses inspected that year, 63,926,693
(or .9 percent) were condemned. Today, more than 7,300 FSIS inspectors
enforce the inspection laws in approximately 6,200 meat and poultry
establishments. Inspection activities start prior to slaughter and
continue throughout processing, handling, and packaging.
FSIS ensures compliance with inspection laws and regulations
outside inspected establishments through control and condemnation of
misbranded or adulterated products. Specifically, during FY 1993, FSIS
detained suspect products 796 times (involving 13,081,409 pounds of
product) and monitored product recalls 36 times (involving 5,726,378
pounds of product). During the same period, 145,526 meat and poultry
product labels were reviewed; 10,154 were not approved. Other measures
FSIS uses to enforce the regulations include withholding inspection
pending correction of serious problems, controlling product
distribution, working with companies to recall violative products, and
seeking court-ordered product seizures when necessary.
The Performance-Based Inspection System (PBIS) is a modernization
initiative implemented in processing establishments during 1989. PBIS
is a structured, automated information system that helps the Agency
document findings resulting from inspector tasks; record deficiencies
found and actions taken; and discuss deficient findings and corrective
actions with establishment management. PBIS is intended to make
processing inspection more uniform nationwide and provides FSIS with
its first easily accessible database on establishment performance. It
enables the Agency to capture, store, and sort the vast quantities of
information generated by the 13 million inspection tasks performed in
processing establishments each year. These data allow the Agency to
examine the long-term operation of a particular establishment or the
performance of a particular control point nationwide. Decisions on
inspection intensity are based on these data, although the frequency is
never less than one visit per day.
FSIS expects to implement PBIS in slaughter operations during FY
1996.
Foodborne Illness in the United States
The safety of the meat and poultry supply has been widely discussed
during the past few years. Although food safety can be affected by
multiple factors, including animal drug and pesticide residues and
unintentional environmental contaminants, the following discussion
focuses on pathogenic microorganisms that are associated with foodborne
illness, including the illness and preventable deaths associated with
meat and poultry consumption. Pathogenic microorganisms are widely
recognized by scientists to be the most significant causes of foodborne
illness.
Foodborne illness can strike individuals of all ages, sexes,
nationalities, and socioeconomic levels. The most common types of
foodborne illness associated with pathogenic microorganisms typically
appear as acute gastroenteritis with sudden onset of vomiting or
diarrhea, or both, with accompanying abdominal pain. However, the exact
combination of symptoms may vary widely, depending on the type of
microorganism and the immune status of the person infected. For
example, certain types of bacteria often cause bloody diarrhea,
including E. coli 0157:H7 and, in a smaller percentage of cases,
Campylobacter jejuni. E. coli 0157:H7 produces a strong toxin (``shiga-
like'' toxin) which can lead to blood clotting abnormalities and kidney
failure (hemolytic uremic syndrome) and can cause death, especially in
young children and the elderly. Even if recovery from the acute illness
is complete, 15-30 percent of persons with hemolytic uremic syndrome
will have evidence of chronic kidney disease. While Salmonella
ordinarily causes transitory and non-life-threatening acute
gastroenteritis, Salmonella can get into the bloodstream of some
infected patients, particularly patients who are very young, very old,
or immunosuppressed (such as persons with AIDS); these bloodstream
infections can have serious complications, including death. Infections
caused by Salmonella may also trigger autoimmune phenomena, such as
reactive arthritis, which may result in long-term disability.
While there is general consensus that foodborne illness is a major
cause of morbidity and mortality in this country, estimates of the
incidence of foodborne illness vary widely. The Centers for Disease
Control and Prevention (CDC) maintains a national foodborne disease
surveillance system, but the data in this [[Page 6781]] system are
recognized not to provide an accurate estimate of foodborne disease
incidence. With the exception of a few pathogens, the data deal only
with outbreaks (two or more cases of illness linked to a common
source); are based on voluntary reporting by State health departments;
and are dependent almost entirely on passive surveillance (that is,
cases and outbreaks voluntarily reported to local health authorities).
A somewhat better picture of disease incidence can be obtained
through national laboratory-based reporting systems. The model for this
is the CDC system for reporting of salmonellosis. Again, however, data
are in most instances passively collected, and are dependent on
physicians submitting cultures; if a patient does not see a doctor, or
the doctor does not collect a stool culture, the case does not enter
the reporting system. Further, of the major foodborne pathogens,
laboratory-based surveillance is available only for Salmonella.
Recognizing these deficiencies, a number of groups have attempted to
estimate actual rates of disease occurrence, drawing both from CDC
databases (with their inherent limitations, discussed above) and
extrapolating from population-based studies in specific geographic
areas. ``Best estimates'' of the incidence of specific diseases, and
the percentage of these diseases thought to be foodborne, are provided
in Table 1, below (together with the source of these estimates). These
estimates are in basic agreement with compilations put together by
expert committees of the National Academy of Sciences and, most
recently, by the Council for Agricultural Science and Technology.
Taken together, these data 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 annually with meat and poultry products
contaminated with pathogenic microorganisms. Even these estimates may
be low; at least one investigator has suggested that total cases of
foodborne illness may reach 33 million cases a year, with up to 9,000
deaths.
Table 1.--Sources of Data for Selected Foodborne Pathogens, 1993
--------------------------------------------------------------------------------------------------------------------------------------------------------
Percent
Pathogen Total cases (#) Total Source(s) for case and death foodborne Source
deaths (#) estimates (%)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Bacteria:
Campylobacter jejuni or coli.... 2,500,000 200-730 Tauxe............................ 55-70 Tauxe et al.
Clostridium perfringens......... 10,000 100 Bennett et al.................... 100 Bennett et al.
Escherichia coli O157:H7........ 10,000-20,000 200-500 AGA Conference................... 80 AGA Conf./CDC comm.
Listeria monocytogenes.......... 1,795-1,860 445-510 Roberts and Pinner............... 85-95 Schuchat.
Salmonella...................... 800,000-4,000,000 800-4,000 Helmick et al./Bennett et al..... 87-96 Bennett et al./Tauxe & Blake.
Staphylococcus aureus........... 8,900,000 7,120 Bennett et al.................... 17 Bennett et al.
Parasite:
Toxoplasma gondii............... 4,111 82 Roberts et al.................... 50 Roberts et al.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sources:
American Gastroenterological Association Consensus Conference on E. coli O157:H7, Washington, DC, July 11-13, 1994.
Bennett, J.V., S.D. Holmberg, M.F. Rogers, and S.L. Solomon. 1987. ``Infectious and Parasitic Diseases,'' In R.W. Amler and H.B. Dull (Eds.) Closing the
Gap: The Burden of Unnecessary Illness. Oxford University Press, New York.
Helmick, C.G., P.M. Griffin, D.G. Addiss, R.V. Tauxe, and D.D. Juranek. 1994. ``Infectious Diarrheas.'' In: Everheart, JE, ed. Digestive Diseases in the
United States: Epidemiology and Impact. USDHHS, NIH, NIDDKD, NIH Pub. No. 94-1447, pp. 85-123, Wash, DC: USGPO.
Roberts, T., K.D. Murrell, and S. Marks. 1944. ``Economic Losses Caused by Foodborne Parasitic Diseases,'' Parasitology Today. vol. 10, no. 11: 419-423.
Schuchat, Anne, CDC, personal communication with T. Roberts at the FDA Science Forum on Regulatory Sciences, Washington, DC, September 29, 1994.
Tauxe, R.V., ``Epidemiology of Campylobacter jejuni infections in the United States and other Industrialized Nations.'' In Nachamkin, Blaser, Tompkins,
ed. Campylobacter jejuni: Current Status and Future Trends, 1994, chapter 2, pages 9-19.
Tauxe, R.V. and P.A. Blake, ``Salmonellosis'' rest of reference unknown.
Tauxe, R.V., N. Hargrett-Bean, C.M. Patton, and I.K. Wachsmuth. 1988. ``Campylobacter Isolates in the United States, 1982-1986,'' Morbidity and
Mortality Weekly Report, vol 31, no. SS-2: page numbers unknown.
Table 2.--Medical Costs and Productivity Losses Estimated for Selected Human Pathogens, 1993
--------------------------------------------------------------------------------------------------------------------------------------------------------
Foodborne illness Percent Meat/poultry related Total
----------------------------------- Foodborne* from ----------------------------------- costs*
Pathogen costs (bil meat/ meat/
Cases (#) Deaths (#) $) poultry Cases (#) Deaths (#) poultry
(%) (bil $)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Bacteria:
Campylobacter jejuni or coli.................. 1,375,000-1,750,0
00 110-511 0.6-1.0 75 1,031,250-1,312,5
00 83-383 0.5-0.8
Clostridium perfringens**..................... 10,000 100 0.1 50 5,000 50 0.1
Escherichia coli 0157:H7...................... 8,000-16,000 160-400 0.2-0.6 75 6,000-12,000 120-300 0.2-0.5
Listeria monocytogenes........................ 1,526-1,767 378-485 0.2-0.3 50 763-884 189-243 0.1-0.2
Salmonella.................................... 696,000-3,840,000 696-3,840 0.6-3.5 50-75 348,000-2,880,000 348-2,610 0.3-2.6
Staphylococcus aureus**....................... 1,513,000 1,210 1.2 50 756,500 605 0.6
-----------------------------------------------------------------------------------------------------
Subtotal.................................... 3,603,526-7,130,7
67 2,654-6,546 2.9-6.7 N/A 2,147,513-4,966,8
84 1,395-4,191 1.8-4.8
[[Page 6782]]
Parasite:
Toxoplasma gondii............................. 3,056 41 2.7 100 2,056 41 2.7
=====================================================================================================
Total....................................... 3,606,582-7,133,8
23 2,695-6,587 5.6-9.4 N/A 2,149,569-4,968,9
40 1,436-4,232 4.5-7.5
--------------------------------------------------------------------------------------------------------------------------------------------------------
The costs of the foodborne illnesses (see Table 2, above) are borne by
those who become ill and their families, coworkers, and employers, as
well as the food industries, and taxpayers. Costs to stricken
individuals include medical bills, time lost from work, pain and
inconvenience. Food industry costs include possible product recalls,
establishment closings and cleanup, and higher premiums for product
liability insurance. Perhaps most costly in the long term is loss of
product reputation and reduced demand when an outbreak is traced back
and publicized. These and other ``defensive'' industry costs of
foodborne disease run in the millions of dollars annually and are, for
the most part, entirely avoidable. Taxpayer costs include medical
treatment for those who cannot afford it and higher health insurance
premiums.
Other taxpayer costs include public health-sector expenses to
operate a disease surveillance system and to investigate and eliminate
disease outbreaks. Approximately $300 million is spent on microbial
foodborne disease annually by the Federal public health-sector. Federal
costs average about $200,000 per foodborne illness outbreak.
The Department's Economic Research Service and CDC estimate the
cost of all foodborne illness in 1993 to have been between $5.6 and
$9.4 billion. Meat and poultry products were associated with
approximately $4.5-$7.5 billion; the remaining $1.1 to $1.9 billion was
associated with non-meat and poultry sources. Table 2 summarizes data
on a pathogen-by-pathogen basis.
Foods contaminated with pathogenic microorganisms can lead to
infection and illness in two major ways. The first is by direct
consumption of the contaminated food under conditions that allow the
survival of the pathogen or its toxin, such as when a meat or poultry
product is consumed raw or undercooked, or products precooked during
processing are recontaminated and consumed directly. The second is
through cross-contamination in the kitchen or other food-handling
areas, for example, when raw chicken or beef with a Salmonella-
contaminated exterior contaminates a person's hands, a cutting board,
countertop, or kitchen utensil, which then comes into contact with
cooked product or foods consumed raw, such as salad. For some
pathogens, such as Salmonella, it is likely that more cases of illness
result from cross-contamination than from direct consumption of
undercooked product.
Microbiological surveys of meat and poultry products have been
conducted by FSIS over several decades. In cooked, ready-to-eat
products, the frequency of pathogenic microorganisms has been
relatively low. In regulatory testing programs of domestically
produced, cooked, ready-to-eat meat and poultry products, for example,
Salmonella has generally been found to be present in only about 0.1
percent of the samples tested and Listeria monocytogenes in about 1.5-3
percent of samples tested.
The frequency of pathogenic microorganisms in raw, ready-to-cook
products has been greater. For example, FSIS has conducted surveys on
the prevalence of Salmonella in various raw products, including broiler
chickens, beginning as early as 1967. In these surveys, Salmonellae
were isolated from 28.6 percent of 597 samples in 1967; from 36.9
percent of 601 samples in 1979; from 35.2 percent of 1693 samples in
the 1982-1984 study; and from approximately 25 percent of the samples
in the 1990-1992 study. FSIS studies on fresh pork sausage involved
retail-size samples. Salmonellae were isolated from 28.6 percent of 566
samples in 1969, and from 12.4 percent of 603 samples in 1979. A
benchmark study on raw beef was initiated in January 1987 and completed
in March 1990. The prevalence of Salmonella in 25 gram portions was
found to be 1.6 percent, the prevalence of Listeria monocytogenes was
7.1 percent and the prevalence of E. coli 0157:H7 was 0.1 percent.
In 1992, FSIS began a series of Nationwide Microbiological Baseline
Data Collection Programs designed to provide a microbiological profile
of various classes of inspected product. The first, on steer and heifer
carcasses, was reported in January 1994. Clostridium perfringens was
recovered from 2.6 percent of 2,079 carcasses; Staphylococcus aureus
from 4.2 percent of 2,089 carcasses, Campylobacter jejuni/coli from 4.0
percent of 2,064 carcasses; E. coli 0157:H7 from 0.2 percent of 2,081
carcasses; and Salmonella from 1.0 percent of 2,089 carcasses.
The ongoing outbreaks of salmonellosis, attributed to consumption
of contaminated meat, poultry and other food products, and the recent
outbreaks of illness caused by E. coli 0157:H7 in undercooked ground
beef, illustrate how serious the public health threat can be, even when
the incidence of contamination of carcasses is relatively low.
For example, on January 13, 1993, a physician in Washington State
reported to the Washington State Department of Health a cluster of
children with Hemolytic Uremic Syndrome, a serious condition that is
the major cause of acute kidney failure in children. Also reported was
an increase in emergency room visits for bloody diarrhea. This outbreak
was reported to CDC.
Cultures taken from symptomatic patients indicated that E. coli
0157:H7 was the causative organism. During January 16-17 an
epidemiological case-control study conducted by Washington State and
CDC strongly suggested the consumption of hamburgers at a chain of fast
food restaurants as the source of the infection. The investigation
revealed that the hamburger patties were cooked by the restaurants to a
temperature below the Washington State standard of 155 deg.F, and in
some instances below the 140 deg.F then recommended by FDA.
By February 4, 350 people in Washington State had contracted
illnesses of the kind associated with E. [[Page 6783]] coli 157:H7 and,
of these cases, 230 were culture-confirmed. In addition, 12 people had
become ill in Idaho and 30 in Nevada. It was also learned that illness
had occurred among 34 persons in San Diego, California, in December and
January. The outbreaks in each of these States all had in common the
consumption of hamburger at the same chain of fast food restaurants.
The greater proportion of these cases were primary infections, that is,
the persons affected became ill directly from eating contaminated
hamburgers. The other cases were secondary infections--the affected
persons contracted their illnesses through contact with a person who
was infected with the pathogen.
Eventually, four people died and more than 500 other persons became
ill during the course of the epidemic.
An important aspect of the Department's review of this experience
was the finding that the winter 1992-93 outbreak was not caused by a
failure in the operation of the inspection system as currently
designed. Rather, it stemmed in part from an inspection system that
does not directly require the reduction, minimization, or elimination,
if possible, of pathogenic microorganisms in raw product leaving
inspected establishments. The specific pathogen in this example was
highly virulent, meaning that a very low dose was sufficient to cause
illness. During the beef-grinding process, harmful bacteria can easily
be spread throughout a large volume of product. When such product
becomes widely distributed and is cooked inadequately to kill any
pathogens that might be present, preventable deaths may result.
The Relationship Between Foodborne Illness and Consumer Knowledge and
Behavior
The National Academy of Sciences' Cattle Inspection: Committee on
Evaluation of USDA Streamlined Inspection System for Cattle (SIS-C)
(1990) reiterated the theme of numerous other studies, ``* * * the
public expects the government to ensure zero risk of meat-borne disease
through inspection. The [NAS] committee heard little evidence that the
public is aware that some bacterial contamination of raw meat is
inevitable and no mention of the crucial role of food handling,
preparation, and serving methods in limiting foodborne diseases.'' The
disturbing but real fact that consumers fail to make a connection
between their food handling behavior and safe food recurs throughout
the literature on the subject.
Behavioral research shows that food habits are the most difficult
of all forms of human behavior to change. This finding is supported by
research of consumer knowledge and practices, which indicates that a
large portion of the U.S. population lacks basic food safety
information and skills and engages in food handling and preparation
practices that epidemiological studies have linked with a significant
number of foodborne illness outbreaks. Moreover, little correlation
exists between consumers' food safety knowledge and their food handling
and preparation practices. Even people who characterize themselves as
``knowledgeable'' do not necessarily follow good food safety
procedures.
These findings about consumer behavior related to safe food
handling and preparation support the need for a comprehensive pathogen
reduction effort. Food safety can best be assured only if each
participant in the food system--from the producer all the way through
to the consumer--understands, accepts, and acts on his or her
responsibility for food safety. While FSIS will pursue and support all
possible means of consumer education and outreach, the Agency realizes
that consumer education alone will not control pathogen-related
foodborne illness. This is truer today than ever before, as more people
in our society are assuming responsibility for food handling and
preparation in the home and elsewhere, without experience in food
preparation and knowledge of safe food handling and storage methods.
These people include:
Food service workers, many of whom are high-turnover,
part-time, or teenaged workers who receive inadequate training;
Men and women in the workplace, who have minimal time for
food preparation and often little experience or interest in food
preparation;
Children, who are increasingly expected to shop for and
prepare their own meals;
Immigrants, who might not be able to read food handling
instructions, or whose cultural practices include eating raw or rare
meat and poultry products.
Vulnerable sectors of the population, more severely affected by
foodborne illness, are also increasing in size:
Immunocompromised persons (i.e., persons with diabetes,
cancer, chronic intestinal diseases, organ transplants, and AIDS);
Persons 65 years and older--a growing proportion of the
population--who, due to the normal decline in immune response, are at
increased risk.
In 1993, to increase awareness about pathogens, FSIS promulgated a
regulation requiring safe handling labels on most raw meat and poultry
products. The Agency's Meat and Poultry Hotline provides consumers with
immediate responses to questions about meat and poultry handling and
safety. These steps and other education activities are important but
they are not a substitute for building into the meat and poultry
production and regulatory system measures to reduce to the maximum
extent possible the presence of pathogenic microorganisms in meat and
poultry products purchased by U.S. consumers.
External Studies and Recommendations for Change
During the past decade, the National Academy of Sciences (NAS), the
General Accounting Office (GAO), the National Advisory Committee on
Microbiological Criteria for Food (NACMCF), and consumer groups have
evaluated and called for change in the current inspection system.
In 1983, FSIS asked NAS to evaluate the scientific basis of its
inspection system and recommend a modernization agenda. The resulting
report, Meat and Poultry Inspection: The Scientific Basis of the
Nation's Program, was issued in 1985. This was the first comprehensive
evaluation of the scientific basis for the Federal meat and poultry
inspection system. The report provided a blueprint for change,
recommending that FSIS focus on pathogenic organisms and require that
all official establishments operate under a Hazard Analysis and
Critical Control Point (HACCP) system to control pathogens and other
safety hazards. This report ``encourages FSIS to move as vigorously as
possible in the application of the HACCP concept to each and every step
in establishment operations, in all types of enterprises involved in
the production, processing, and storage of meat and poultry products.''
Two later NAS studies reinforced these recommendations, urging the
Agency to focus on public health goals:
Poultry Inspection: The Basis for a Risk Assessment
Approach (1987) concluded that a risk-assessment approach is needed to
evaluate health hazards associated with poultry. Critical control
points at which known pathogenic microorganisms may be introduced into
the poultry production system should be identified and monitored,
preferably as part of a HACCP program.
The most recent NAS report, Cattle Inspection: Committee
on Evaluation of USDA Streamlined Inspection System for Cattle (SIS-C)
(1990) stated that traditional meat inspection, relying on
[[Page 6784]] organoleptic examinations, is not fully effective in
protecting the public from foodborne health hazards. FSIS was urged to
move to a risk-based inspection system targeted at significant public
health risks, especially those associated with pathogenic
microorganisms.
The GAO has also been advocating improvements in the present
inspection system in reports and Congressional testimony. In numerous
reports (see list below), GAO endorses HACCP as a scientific, risk-
based system to better protect the public from foodborne illness. This
sentiment is most clearly expressed in the 1994 Food Safety: Risk-Based
Inspections and Microbial Monitoring Needed for Meat and Poultry, which
states:
A HACCP system is generally considered the best approach
currently available to ensure safe foods because it focuses on
preventing contamination rather than detecting contamination once it
has occurred.* * * To better protect the public from foodborne
illnesses, we believe FSIS must now move to a scientific, risk-based
inspection system. Such a system would allow FSIS to target its
resources towards the higher risk meat and poultry products and
establishments by increasing inspection of such products and
establishments, developing methods or tools that would help
inspectors detect microbial contamination, increasing product
testing, and helping establishments develop and operate microbial
testing programs.
This report further recommends that Congress ``revise the meat and
poultry acts to provide FSIS with the flexibility and discretion to
target its inspection resources to the most serious food safety
risks.''
These basic recommendations are echoed in the five GAO reports
describing the current inspection system and recommending changes to
improve its effectiveness, listed below:
``Meat Safety: Inspection System's Ability to Detect Harmful
Bacteria Remains Limited'' (1994);
``Food Safety: A Unified, Risk-Based System Needed to Enhance
Food Safety'' (1993);
``Food Safety: Building a Scientific Risk-Based Meat and Poultry
Inspection System'' (1993);
``Food Safety: Inspection of Domestic and Imported Meat Should
be Risk-Based'' (1993);
``Food Safety and Quality: Uniform, Risk-Based Inspection System
Needed to Ensure Safe Food Supply'' (1992).
A third major proponent of HACCP is the National Advisory Committee
on Microbiological Criteria for Foods (NACMCF), which was established
in 1988 by the Secretary of Agriculture to advise and provide
recommendations to the Secretaries of Agriculture and of Health and
Human Services on developing microbiological criteria to assess food
safety and wholesomeness. Since 1989, NACMCF has prepared a series of
reports on the development and implementation of HACCP. As one of its
first tasks, the Committee developed ``HACCP Principles for Food
Production'' in November 1989. In this report the Committee endorsed
the HACCP system as a rational approach to ensure food safety and
delineated seven HACCP principles to standardize HACCP in the
Committee's own work, as well as in industry, regulatory applications,
and training. In 1992, the Committee issued an updated guide, ``Hazard
Analysis and Critical Control Point System.''
To describe the HACCP system more concretely, in 1993 NACMCF
published The Role of Regulatory Agencies and Industry in HACCP. In
that report, NACMCF articulated the roles of regulatory agencies and
industry in implementing HACCP, and recommended what the
responsibilities of FDA, USDA, other agencies and industry should be
during various phases of HACCP implementation.
In June 1993, NACMCF developed a model, ``Generic HACCP for Raw
Beef,'' which provides a HACCP plan for beef slaughter and processing
(see Appendix). It focuses on the slaughter and processing portions of
the total ``farm to consumption'' scope of a complete HACCP program.
Similar recommendations for program change have come from consumer,
industry, State, and local government representatives, as well as other
constituent groups. Consumer representatives at recent public hearings
and the HACCP Round Table held in March 1994 supported implementation
of HACCP throughout the meat and poultry industry.
Industry groups, in clarifying their support for HACCP to control
pathogens, contend that HACCP-based food production, distribution, and
preparation by industry can do more to protect public health than any
Federal inspection program. They recommended that HACCP be used to
anticipate microbiological hazards in food systems and to identify
risks in new and traditional products. State departments of health and
agriculture also endorsed the HACCP approach.
FSIS Agenda for Change
The meat and poultry inspection program currently addresses many
matters of great importance to the safety and quality of the food
supply, including supervision of industry compliance with sanitation
standards, exclusion of diseased animals from the food supply,
examination of carcasses for other visible defects that can affect
safety and quality, inspecting for economic adulteration, and
monitoring for chemical residues. These activities respond to some of
the public's most basic expectations regarding the safety and quality
of the food supply and reflect the standards and requirements
established by Congress in the laws FSIS administers. FSIS is strongly
committed to effectively implementing these statutory requirements.
As the experience of recent years and the many external studies and
reports indicate, however, there is a need for fundamental change in
the FSIS program. The most critical reason for change is the need to
ensure that the FSIS inspection program is fully meeting its paramount
obligation to protect public health. To meet this obligation, there is
a pressing need to better address the public health problem of
foodborne illness associated with the consumption of meat and poultry
products.
As documented in the preceding sections, many cases of foodborne
illness are caused annually by pathogenic microorganisms that enter the
food supply during the slaughter and processing of meat and poultry
products. With respect to raw meat and poultry products, the current
system of inspection addresses this problem only indirectly, by
enforcing sanitation requirements and inspecting for visible fecal and
ingesta contamination and other visible defects that can be pathways
for contamination of carcasses by pathogenic microorganisms.
The current system must be enhanced to deal more directly with
pathogenic microorganisms. In particular, the system needs to be
changed to make better use of the science and tools of microbiology to
reduce, and where possible eliminate, pathogenic microorganisms. Such
change is needed to protect public health.
Change is also needed to clarify the respective responsibilities of
the meat and poultry industries and the FSIS inspection program when it
comes to the safety of the food supply. Companies producing meat and
poultry products are responsible for ensuring that their products are
safe and do not violate any of the statutory provisions defining
adulteration and misbranding. FSIS is responsible for inspecting
products and facilities to verify that these requirements have been met
and for taking appropriate remedial and enforcement actions when the
requirements have not been met. [[Page 6785]]
This line between industry and FSIS responsibility has become
blurred. This may be due in part to the continuous presence of FSIS
inspectors in meat and poultry establishments and the statutorily
mandated USDA inspection legend, which together may have encouraged
some establishments to rely on FSIS to ensure the safety of the
establishment's products rather than take full responsibility
themselves for the safety of their products. Because the FSIS inspector
is obligated to prevent adulterated product from leaving the
establishment, some establishments may operate on the assumption that
what is not specifically prohibited or detected by the FSIS inspector
may continue. This is not acceptable.
Likewise, the FSIS inspection program has too often taken on the
burden of expending significant inspectional resources to bring
establishments into compliance--such as in cases of repeat violators of
sanitation standards--rather than finding efficient means to hold
establishments accountable for complying with applicable standards. As
a result, the inspection resources needed to ensure that all
establishments have appropriate production controls are frequently
spent on intensified inspection of poor performers. For these reasons,
the lines of responsibility for food safety must be clarified.
Finally, change is needed to move toward a more preventive approach
to ensuring the safety of food. The current system relies too heavily
on FSIS inspectors to detect and correct problems after they have
occurred, whether in establishments or after the product has left the
establishment. This is not the most efficient use of FSIS resources,
and, especially in the case of pathogenic microorganisms, it is not
effective in protecting public health. Many meat and poultry
establishments, as well as other segments of the food industry, have
found that safety can best be ensured by systems designed to prevent
food safety problems. To protect public health and make the best use of
its resources, FSIS needs to build the principle of prevention into its
inspection system.
The changes FSIS plans in its inspection program--targeting
pathogenic microorganisms, setting priorities on the basis of public
health risk, clarifying roles and responsibilities, and building in the
principle of prevention--constitute an institutional paradigm shift
that can significantly enhance the effectiveness of the FSIS program
and reduce the risk of foodborne illness.
To achieve such change, FSIS must articulate its food safety goal
in broad terms and adopt a food safety strategy that will work to
achieve both a real reduction of pathogens in the near term and, in the
long term, the fundamental changes in the inspection program that are
needed to better protect public health.
FSIS Food Safety Goal
It is tempting to think of food safety as an absolute. In an ideal
world, there would be no cases of foodborne illness. The world we live
in is, however, far from ideal. The production of the food that feeds
250 million Americans every day is an enormously complex task. It is
undertaken in a natural environment where hazards, including pathogenic
microorganisms, are common. It requires a level of technological
intervention--in the form of machinery, chemicals, and processing--that
itself can introduce hazards. And it is an enterprise that depends, in
the end, on a vast array of human interventions and activities, which
means that human error is a constant factor that can contribute to food
safety hazards.
FSIS believes the public can understand that safety is not an
absolute, and the laws FSIS administers do not speak in absolute terms.
FSIS also believes, however, that public expectations are justifiably
high when it comes to measures the food production system should take
to reduce risk and ensure the safety of food. Furthermore, the laws
FSIS administers set high standards--for example, meat and poultry
products are deemed ``adulterated'' and thus unlawful if they are for
any reason ``unhealthful''--and they empower FSIS to take actions
needed to meet those standards and meet the public's high expectations
concerning the safety of the food supply.
FSIS believes its food safety goal should be to reduce the risk of
foodborne illness associated with the consumption of meat and poultry
products to the maximum extent possible by ensuring that appropriate
and feasible measures are taken at each step in the food production
process where hazards can enter and where procedures and technologies
exist or can be developed to prevent the hazard or reduce the
likelihood it will occur.
There is no single technological or procedural solution to the
problem of foodborne illness, and the Agency's food safety goal will
not be achieved overnight. Indeed, inherent in the nature of the
Agency's goal is the concept that food safety requires continuous
efforts to improve how hazards are identified and prevented. It is
based on the public health principle that, on a continuing basis,
society should seek out and take preventive measures to reduce the risk
of illness. It reflects the Agency's belief that steps that can be
taken today to reduce the risk of foodborne illness should be taken
today, but that steps judged adequate today may not be judged adequate
tomorrow.
In the case of the major enteric pathogens that contaminate meat
and poultry products during the slaughter process, FSIS believes that
the risk of foodborne illness associated with these pathogens is
largely avoidable and can be minimized by proper implementation of
HACCP. This does not necessarily mean absolute elimination of such
pathogens, but it does mean preventing and reducing contamination with
these pathogenic microorganisms to a degree that very substantially
reduces and minimizes the risk of foodborne illness.
Achieving this food safety goal requires long-term commitment and
action by Government and industry. It also requires general agreement
on a regulatory strategy that can achieve the goal.
FSIS Food Safety Regulatory Strategy
FSIS believes that to achieve its food safety goal, and bring about
the change described above, a new regulatory strategy is needed. The
major elements of the Agency's proposed strategy are outlined in this
section, with a brief explanation of how the regulatory changes FSIS is
proposing in this document will advance the strategy.
1. FSIS must clearly define the minimum requirements all
establishments must meet to produce safe meat and poultry products and
make establishments readily accountable for meeting them. Good
sanitation and basic good manufacturing practices (GMP's) are generally
regarded as essential prerequisites for the production of safe food.
The current FSIS program includes sanitation regulations that set out
certain standards of cleanliness establishments are required to meet;
and the Agency has provided guidance, in the form of a Sanitation
Handbook, on how sanitation requirements can be met. FSIS also has
promulgated regulations that impose various specific requirements,
especially regarding processing operations, that might be characterized
as GMPs.
In the sanitation area, however, FSIS has not spelled out clearly
the responsibility every establishment has to install procedures that
ensure sanitation requirements are met every [[Page 6786]] day, both
before operations commence and during operation. In the GMP area,
certain important food safety-related practices that have emerged in
recent years have become recognized by the majority of the industry as
appropriate GMPs, but they have not been made part of the basic
regulatory requirement all establishments must meet.
FSIS believes it is important, especially for the near term, to
codify certain minimum practices all establishments must observe to
produce safe meat and poultry products and to improve the Agency's
ability to hold establishments accountable for following those
practices. Thus, FSIS is proposing: (1) to require that all
establishments develop and adopt standard operating procedures for
their sanitation programs, (2) to require that all slaughter
establishments incorporate at least one effective antimicrobial
treatment to reduce the levels of microorganisms on carcasses before
they enter the chilling step, and (3) to codify specific time and
temperature requirements for cooling of carcasses post-slaughter.
The majority of meat and poultry establishments already observe
some or all of the practices FSIS is proposing to require. They are
basic to producing a safe product, and FSIS believes all establishments
should observe them. By codifying these practices in the Agency's
regulations, FSIS will have an effective means to hold all
establishments accountable for meeting them. Codifying these basic
requirements is by no means a complete or long-term solution to the
food safety problem but rather is part of the Agency's effort to
ensure, as more fundamental improvements are being developed, that
readily available improvements are incorporated into the system in the
near term. FSIS invites comment on whether elements of current GMP's
should be mandated by the Agency.
2. FSIS must stimulate improvement in food safety practices by
setting public health-oriented targets, guidelines, or standards all
establishments must meet. This is the centerpiece of the FSIS food
safety strategy and the most important departure from the Agency's
current regulatory approach. In its past regulation of the slaughter
process and of raw, ready-to-cook meat and poultry products, FSIS has
not clearly defined what safety means or set public health targets,
guidelines, or standards for reducing the incidence of contamination of
these products with human pathogens (pathogens that cause illness in
humans). Consequently, there has been no basis for evaluating from an
objective, public health standpoint whether the measures establishments
have taken to prevent harmful contamination are adequate or should be
deemed acceptable. FSIS has instead focused on managing its current
system of visual inspection and encouraging industry efforts to reduce
pathogens, but without an effective tool for requiring or evaluating
those efforts.
FSIS believes that setting public health targets, guidelines, or
standards is the most powerful and effective tool available for
bringing about changes in FSIS-inspected establishments, especially
slaughter establishments, that will reduce levels of pathogenic
microorganisms and improve the safety of meat and poultry products. The
concept is simply that, by establishing targets, guidelines, or
standards establishments are required to meet, FSIS can stimulate the
innovation and change needed to reduce risk from all sources of
foodborne hazards--whether biological, chemical, or physical--and, at
the same time, have a tool for holding all establishments accountable
for achieving an acceptable level of food safety performance.
FSIS realizes that this new approach raises some new and difficult
scientific and policy issues and thus may be controversial in some
quarters. The most important issues concern the basis upon which the
targets, guidelines, or standards (hereafter referred to generally as
``microbial limits'') will be set and the consequences for an
establishment that does not meet them.
There are many possible approaches for setting and using microbial
limits. One approach is to set specific quantitative limits for each
significant pathogenic microorganism on the basis of a scientific risk
assessment, and to use this limit as the basis for excluding from
commerce any raw product that exceeds the limit. This is the approach
typically taken in the regulation of food additives, chemical
contaminants, and physical defects, and provides the most direct and
perhaps most effective means of ensuring that standards necessary to
protect public health are being met. One difficulty with this approach
to pathogenic microorganisms is that the scientific data and
understanding concerning the link between specific levels of many
pathogens and the risk of foodborne illness that would be needed to set
such limits based solely on considerations of public health are not
currently available. A second, perhaps more significant difficulty is
the fact that the levels of additives and other chemicals generally
remain stable, whereas levels of microorganisms can change over time,
due to growth and destruction. As explained in a later section of this
document, FSIS intends to work with the scientific and public health
communities to develop the scientific basis for setting quantitative
limits for specific pathogens.
Another approach to pathogen reduction is to set targets for
reduction based on what is judged achievable with available science and
technology, and to require individual establishments to meet such
targets on a consistent basis, by adoption of appropriate process
controls. Even with this approach, there are difficult issues
concerning the basis upon which such targets should be set. FSIS
believes, however, that enough is known today and can be learned during
the course of this rulemaking to make this approach viable and very
useful in the near term.
Later in this document, FSIS is proposing to set interim targets
for pathogen reduction, using as the starting point the current
baseline incidence of Salmonella contamination of finished carcasses in
all raw meat and poultry slaughter operations and in raw ground meat or
poultry products, and requiring reductions in Salmonella in relation to
the current baseline. FSIS believes that significant reductions in the
incidence of contamination with this human pathogen are achievable in
the relatively near term, and that the process improvements some
establishments will have to make to reach the goal will also reduce the
levels of other pathogens.
Key to the FSIS strategy for using public health-based microbial
limits to reduce pathogens is the recognition that what is
scientifically supportable and appropriate will evolve over time. FSIS
believes the interim step it is proposing in this new area to target
and reduce the incidence of Salmonella is feasible and can be effective
in the near term, but it is just a first step. As knowledge and
methodologies improve, additional pathogens could be targeted, targets
could be lowered, and the use of the targets could expand eventually to
include their use in some cases as legal standards for products.
FSIS will be working closely in the coming years with the
scientific and public health communities, the industry, and public
interest groups to consider how microbial limits can best be used to
reduce the risk of foodborne illness. Later in this document, FSIS
discusses some of the difficult scientific issues that need to be
resolved to make the fullest use of microbial limits.
3. FSIS must make meat and poultry establishments responsible for
microbial testing of their products to ensure proper process control
and verify achievement of microbial limits. To [[Page 6787]] reduce
pathogens and protect public health, FSIS believes that microbial
testing must become an integral part of the operation of every meat and
poultry establishment and that the primary responsibility for testing
should rest with the establishment, not FSIS. Over the long term,
microbial testing will play a key role in verifying the successful
implementation of an establishment's HACCP plan. FSIS also believes
that establishments should be responsible for testing their products to
verify achievement of any microbial limits that FSIS establishes for
regulatory purposes. Later in this document, FSIS is proposing to
require daily microbial testing to determine whether, over time, the
proposed interim targets for pathogen reduction are being met in all
establishments that have slaughter operations or produce raw ground
meat or poultry products.
4. FSIS must foster scientific and technological innovation within
the meat and poultry industries to reduce pathogens and the risk of
foodborne illness and must remove any unnecessary regulatory obstacles
to innovation. In the past, innovation in the meat and poultry
industries has been directed primarily to developing new products and
increasing productivity. This innovation has been beneficial because it
has responded to consumer demand and need for a diverse, convenient,
and economical food supply. One of the principle advantages of holding
establishments accountable for meeting public health-driven microbial
limits is to provide an incentive for establishments to innovate as
they reduce the risk of foodborne illness.
FSIS believes that scientific and technological innovation in the
meat and poultry industry will play a key role in meeting the Agency's
food safety goal. FSIS will, therefore, be reviewing its current
procedures for evaluating and approving new pathogen reduction
technologies for use in meat and poultry establishments, and is
committed to modifying or eliminating any procedures or requirements
that stand as unnecessary obstacles to the prompt implementation by
industry of innovations that can reduce the risk of foodborne illness.
FSIS invites public comment on how FSIS can improve its program to
facilitate beneficial innovation.
5. FSIS must build the principle of prevention into the operations
of meat and poultry establishments and into the FSIS inspection
program. As discussed earlier in this document, food safety can be
ensured most effectively and economically by installing systems that
prevent problems from occurring rather than relying on end product
testing or government inspection to detect and correct problems after
they occur. There is wide agreement on this among government and
industry officials, consumers and the scientific community. FSIS is
proposing to build the principle of prevention into the inspection
system by requiring that all meat and poultry establishments adopt and
operate under HACCP systems.
6. FSIS must approach its food safety mission broadly, and address
potential hazards that arise throughout the food production and
delivery system, including before animals enter FSIS-inspected
establishments and after meat and poultry products leave those
establishments. There is wide agreement 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. Although not the subject of this document, FSIS will
work with producers and others to develop and implement ``preharvest''
food safety measures--measures that can be taken on the farm to reduce
the risk of harmful contamination of meat and poultry products.
FSIS is also announcing in this document initiatives it plans to
undertake in cooperation with the Food and Drug Administration to
develop Federal standards that will help ensure the safe handling of
meat and poultry products during transportation from FSIS-inspected
establishments to the retail level. FSIS and FDA will also work
together to encourage adoption and enforcement by State governments of
consistent, science-based standards at the retail level.
FSIS believes that its food safety goal can be achieved and
legitimate public expectations met only by building a chain of
responsibility for food safety, extending all the way from the farm to
the consumer.
In the next part of this document, FSIS proposes a set of
regulatory changes that it believes will advance the Agency's food
safety regulatory strategy.
II. Discussion of Regulatory Proposals
Overview
Because the safety of any meat or poultry product can be positively
or adversely affected at virtually every step in the manufacturing
process, FSIS is proposing the series of regulatory changes discussed
in this section. Collectively, these changes would reduce the incidence
of pathogenic microorganisms on meat and poultry products, not only by
reducing their numbers at critical points during processing, but also
by denying those pathogens that are present the opportunity to grow.
As independent measures, standard operating procedures for
sanitation, antimicrobial treatments, and time and temperature
requirements for chilling and cooling finished carcasses and parts
could have only limited impact on food safety. Together, they can make
a significant contribution to reducing pathogenic microorganisms and
other contaminants throughout the manufacturing process. These measures
are a precursor to HACCP, which ensures process control through
carefully selected critical control points. The above-listed measures,
discussed at length in II A, have in fact been implemented in many
establishments, including many now operating under HACCP systems. By
effecting immediate pathogen reduction in meat and poultry products
during the period of transition to HACCP, these interdependent measures
would address urgent public health needs. Additionally, implementing
these measures would introduce into non-HACCP establishments the
concept and actuality of process control, which is the essence of
HACCP. Each proposed measure can be reasonably expected to constitute a
critical control point under most HACCP plans so, while the proposed
regulatory provisions may no longer need to be mandated upon
implementation of HACCP, establishments would likely retain them as
critical elements of process control.
The second component of this three-part regulatory package, the
microbiological testing program (discussed under II B), would also be
implemented during the transition to HACCP. It, too, is integral to the
regulatory strategy, because microbial testing will establish a
tangible, achievable, measurable target: a reduction in the incidence
of Salmonella in raw product. As with the near-term interventions
discussed above, the microbial testing program would effect pathogen
reduction almost immediately upon implementation. As is the case with
the near-term interventions, microbial testing can be expected to
constitute an element of process control under HACCP.
The third component of this three-part regulatory package is HACCP
(discussed under III C). As indicated earlier, the interim measures
which, as proposed, would be implemented during the transition to HACCP
would likely continue under HACCP as elements of process control,
selected on [[Page 6788]] the basis of each establishment's hazard
analysis.
The proposed sanitation SOP's, antimicrobial treatment, cooling,
and microbial testing requirements are compatible with and establish
important parts of the foundation for establishments' subsequent
adoption of HACCP procedures. It is expected that HACCP controls will
give establishments the flexibility to meet the objectives reflected in
FSIS's existing requirements for meat and poultry products. Once HACCP
systems are integrated fully into all establishments, many existing
regulations may be redundant. Anticipating the implementation of HACCP
proposed in this document, FSIS has initiated a review of existing
regulations, with the intention of removing those no longer needed, as
well as of ensuring that regulations that remain are sufficiently
flexible to be HACCP-compatible. FSIS invites comment on which
regulations should be eliminated or modified. Even now, it may be
possible to identify means to achieving prescribed regulatory ends that
are as effective as the means set forth in current regulations--that
are, in other words, ``equivalent'' to provisions set forth in
regulations. FSIS invites comment on specific regulations for which
such performance standards might be appropriate, either immediately or
upon implementation of HACCP.
A. Transition to HACCP
The following is a discussion of regulations being proposed which,
together, are intended to reduce significantly the level and frequency
of consumers' exposure to foodborne illness associated with pathogenic
microorganisms and other biological, chemical, and physical hazards in
meat and poultry products.
The transitional regulations proposed in this document would be
made effective 90 days after publication of the final rule (near-term
initiatives). The proposed HACCP requirements would be implemented in
phases during the three years following the publication of the final
rule. As noted above, the near-term initiatives are designed to reduce
the level and frequency of consumers' exposure to pathogenic
microorganisms now, pending the more comprehensive controls that will
be in place in each establishment under the proposed HACCP regulations.
The proposed regulations, roughly in order of their sequence in
slaughter and processing operations, are as follows:
A requirement that all federally inspected establishments
develop and adhere to written standard operating procedures (SOP's)
specifically relating to direct contamination or adulteration of
product;
A requirement that slaughter establishments use an
antimicrobial treatment on all carcasses;
A requirement to meet specific time requirements for
chilling and cooling of all finished carcasses and parts;
A requirement that certain raw product be tested for
Salmonella, a representative pathogen, and that establishments achieve
targeted reductions in the incidence of Salmonella, in relation to the
current national baseline incidence, in 2 years (discussed under II B,
below);
A requirement that all establishments adopt HACCP systems
(discussed under II C, below).
FSIS intends to proceed to final rulemaking on the specific changes
proposed in this document as soon as possible. After comments are
reviewed and analyzed, if it is determined that some portions of this
proposal can be made into final rules sooner than others after the
close of the comment period, they will be separated from the other
portions so as to not delay regulatory action on this important public
health matter.
These proposals reflect ideas and suggestions generated from many
people and organizations. Recent events have prompted a beneficial,
ongoing dialogue between FSIS and consumer organizations, trade
associations, and other Government agencies, among others, as well as
among FSIS employees and their bargaining representatives, on what
regulatory changes the Agency should undertake. FSIS values and relies
greatly on the input from all these sources, and intends to continue
this dialogue throughout this rulemaking and in its future regulatory
activities.
1. Sanitation Standard Operating Procedures (SOP's)
Need for SOP's
Proper sanitation is an important and integral part of every food
process and a fundamental requirement under the law. Insanitary
facilities and equipment, and poor food handling and personal hygiene
practices among employees create an environment in which pathogens can
flourish. The law is quite clear: product produced or held under
insanitary conditions is deemed adulterated, without any further
showing required by the Government. FSIS inspectors are expressly
charged with ensuring that product inspected and passed was in fact
produced under sanitary conditions.
FSIS recognizes that current sanitation practices and performances
vary widely among the diverse array of plants FSIS regulates. Well-run
meat and poultry establishments have tight quality control and
sanitation programs, including written sanitation SOP's, premised in
large part on the direct and substantial link between the existence of
insanitary conditions during production of meat and poultry products
and the likelihood that bacteria--including pathogenic bacteria--will
contaminate the finished product. Some establishments, however, do not
have adequate programs and do not consistently maintain good
sanitation. FSIS is nearing completion of its project to conduct
unannounced reviews of 1,000 federally inspected meat and poultry
establishments. The findings, based on 551 reviews so far, show that 60
percent (820) of 1,340 serious deficiencies were found in sanitation.
Poor sanitation is the most frequently observed problem in meat and
poultry establishments.
FSIS is proposing to require that all inspected establishments
develop written sanitation SOP's to prevent direct contamination or
adulteration of product before and during operations. Establishments
would be required to maintain daily records to document adherence to
the SOP's. The proposed sanitation SOP's would be compatible with the
proposed HACCP requirement. Like HACCP, the sanitation SOP's reflect a
commitment by establishment management to consistently control
operations in the interests of public health. The SOP's demonstrate
that establishment owners know their operations and how to keep the
facilities and equipment clean. FSIS encourages both innovation and
self-reliance in the achievement of good sanitation in all inspected
establishments.
Self-reliance is important because identification of sanitation
requirements has been viewed by some establishment owners and personnel
as the inspector's responsibility. Such establishments often fail to
take the initiative to find and remedy insanitary conditions, relying
instead on the inspector to find deficiencies.
Mandatory sanitation SOP's are intended to clarify that sanitation
is industry's responsibility, not the inspector's. The sanitation SOP's
reflect the establishment's commitment to accomplish those activities
consistently, independent of the inspector.
Written SOP's would make it easier for FSIS inspectors to perform
their proper role of verifying that establishment management is
conducting its operations in a sanitary [[Page 6789]] environment and
manner. Failure to adhere to the ``core elements'' of an SOP (the
proposed regulatory requirements) would be presumptive evidence of
insanitation and enforcement action, where necessary, would be taken.
As is now the case, inspectors will not permit an establishment to
operate under insanitary conditions. Falsification of records designed
to document daily sanitation activities would, in addition to
indicating insanitation, be treated as a criminal act subject to
prosecution.
As a more efficient tool for ensuring that establishments are
carrying out their sanitation responsibilities, sanitation SOP's can
provide the basis for improved utilization of FSIS inspectional
resources. Sanitation SOP's thus support the transition to HACCP
because, under HACCP, FSIS inspectors will be called upon to perform a
number of additional safety-related inspectional tasks to verify that
HACCP plans are working properly. If less time can be spent ensuring
that basic sanitation requirements are being met, more time will be
available for these new tasks.
Some plants already have SOP's, take their sanitation
responsibilities seriously, and require a relatively modest investment
of inspector time to ensure sanitation requirements are met. Other
plants do not consistently perform well in the sanitation area and
frequently require a substantial investment of inspector time to ensure
basic sanitation compliance before daily operations begin.
In plants where procedural requirements are consistently followed
and inspectional observations verify that good sanitation is being
consistently achieved, FSIS expects that sanitation SOP's will provide
the basis for adjusting the manner and frequency of FSIS preoperational
sanitation inspection.
FSIS invites comment on the role sanitation SOP's should play in
allocating responsibility between establishment employees and FSIS
inspectors for preoperational sanitation, including the role FSIS
employees should play in authorizing daily startup of operations.
Content of SOP's
Sanitation SOP's would, at a minimum, detail procedures the
establishment will conduct to prevent direct contamination or
adulteration of product before and during operations. Such procedures
would constitute the required, core elements of an SOP. The SOP's would
also identify establishment personnel responsible for evaluating the
conduct and effectiveness of the sanitation SOP's, and for making
corrections when needed. FSIS encourages establishments to incorporate
additional sanitation procedures that provide increased assurance that
insanitary conditions will be prevented.
Each establishment would maintain a daily record of the actions
prescribed in the SOP, and make such records available to Program
employees for inspection audit and verification. Records would, at a
minimum, record deviations from the core elements of the SOP (the
proposed regulatory requirements), along with corrective actions taken
in conjunction with the monitoring of daily sanitation activities.
Production could not start until the core elements of the sanitation
SOP's that are applicable to preoperational sanitation have been
completed.
The daily monitoring of the sanitation program by the establishment
representative could include microbiological tests, routine
organoleptic inspection of areas and equipment, and direct observation
of sanitation procedures while being performed by designated employees.
FSIS will provide guidance materials, including examples, on
development of sanitation SOP's prior to the implementation of this
requirement.
The following are specific practices relating to sanitation that
might be included in an SOP:
Preoperational microbiological testing: Tests for
verifying the efficacy of cleaning, sanitizing, and disinfecting
procedures. Many establishments also currently perform preoperational
microbiological testing for quality control purposes. The technology
for preoperational sanitation microbiological testing is readily
available and easy to use.
Disinfection of equipment prior to startup: Some data
exist to indicate that equipment should be sanitized immediately prior
to the startup of operations.
Use of an automated hand washer with approved sanitizing
solution effective for up to six hours. This has been proven to be an
important sanitary practice.
Handwashing between each carcass in skinning and
evisceration operation.
Cleaning cattle prior to slaughter: Washing and drying,
clipping, dehairing, and any other acceptable method to remove dirt,
fecal matter and other potential sources of contamination from the
exterior of animals before the edible portions of the carcasses are
exposed. The hides of animals are a known source of carcass
contamination. Feedlot cattle in general and most bovines during the
winter and ``mud season'' carry heavy loads of mud, fecal material and
bacterial contamination on the hide. Sanitary removal of the hide under
these conditions is very difficult. One method to control this source
of contamination is washing animals prior to slaughter. Another
possibility is clipping the hair over the areas where opening cuts will
be made and sanitizing the hide prior to cutting. Yet another procedure
being tested is the complete removal of hair from the hide using a
chemical hair remover (depilatory).
The Agency has been asked to consider making mandatory certain
GMP's for sanitary slaughter by, among others, the American Meat
Institute. The Agency is requesting comments on whether GMP's or other
sanitation practices should be made mandatory elements of the
sanitation SOP.
The adoption of HACCP systems by establishments would not replace
the need for establishments to maintain sanitation SOP's. The proposed
HACCP regulations require sanitation SOP's as a prerequisite to a HACCP
plan. Sanitation activities that directly affect the control of a
processing hazard would be determined according to the criteria
discussed in the HACCP portion of this document, and would, where
appropriate, be identified as critical control points in individual
HACCP plans. Sanitation activities not identified as critical control
points under HACCP should remain in the sanitation SOP's. Any SOP
requirement incorporated into a HACCP plan could be removed from the
SOP's for sanitation.
2. Antimicrobial Treatments
This proposed rulemaking would require, for the first time, that
slaughtering establishments apply antimicrobial treatments or
interventions to livestock and poultry carcasses. Under the proposal,
any one or more of the treatments would have to be applied prior to the
chilling or cooling operation. Mandating antimicrobial treatments is a
new approach for FSIS. It reflects the judgment that, at least until
significant progress is made in reducing or eliminating the presence of
pathogenic microorganisms in livestock and poultry at the preharvest
stage and in sanitary dressing techniques and practices, some amount of
contamination of beef and poultry carcasses with pathogenic
microorganisms is likely to occur--even in establishments that attempt
to follow the best current practices. To reduce the food safety hazard
posed by such pathogens, establishments should be
[[Page 6790]] required to take affirmative measures to reduce or
eliminate contamination.
One concern regarding the use of antimicrobial treatments is that
such treatments will be relied on as a substitute for careful sanitary
dressing techniques which provide the best opportunity to prevent
contamination from occurring in the establishment. Other concerns are
that some treatments are ineffective at least for certain organisms,
and certain treatments, such as carcass washes or soaks, might make
matters worse by spreading contamination and can cause economic
adulteration.
FSIS agrees that antimicrobial treatments must not be allowed to
substitute for careful sanitary dressing procedures, and that any
interventions must be effective and not result in economic
adulteration. FSIS also agrees that no one treatment will be effective
for all pathogens of possible public health concern. FSIS believes that
the best way to prevent harmful contamination of meat and poultry
products is by adopting multiple approaches throughout production,
slaughter, and processing that will contribute to preventing or
reducing the likelihood and degree of microbial contamination,
especially by pathogens.
FSIS believes that mandating at least one antimicrobial treatment
prior to the chilling process is an integral part--but only one part--
of the strategy for reducing pathogens on meat and poultry proposed in
this document. Product not properly treated with at least one
antimicrobial treatment would be retained; the Inspector in Charge
would determine its disposition. FSIS invites public comment on this
approach, as well as on the issues raised in the discussion below
concerning what treatments are effective and appropriate.
Past and Current Agency Policy
Despite establishment's best efforts to reduce or eliminate
contamination during slaughter and dressing procedures, livestock and
poultry carcasses still may harbor pathogenic microorganisms. The
sources of these organisms, most of which are associated with the
living livestock and poultry, are not fully understood, and fully
effective preharvest preventive measures, while under study, are not
currently available. Thus, introduction of pathogenic microorganisms
into establishments along with the animals cannot be absolutely
prevented at this time. The use of the best slaughter and sanitary
dressing procedures and technologies can reduce the likelihood that
product will be contaminated by these invisible pathogens, but they
cannot guarantee the absence of pathogenic bacteria on raw meat or
poultry product.
FSIS recognizes that the technologies now available for reducing
bacterial contamination on raw carcasses are limited. Indeed, the
inspection regulations currently have no listings for antimicrobial
agents as such. However, FSIS has over the years permitted a number of
such treatments to be used in inspected establishments on a case-by-
case basis, and is proposing to include some of these in the
regulations through this rulemaking. Some currently available treatment
methods are described below.
New antimicrobial procedures, including variations on those listed
below, will be approved for use by FSIS to meet the proposed
requirement for an antimicrobial treatment, provided data are submitted
demonstrating they are safe and effective for that purpose. Current
interventions generally provide at least a one order of magnitude
(i.e., a 90-percent) reduction in the numbers of bacteria of concern on
treated carcasses.
Antimicrobial treatments are interventions that decrease
microorganisms present on the surfaces of meat and poultry carcasses.
Antimicrobial treatments are not designed to compensate for sloppy
sanitary dressing procedures on the slaughter floor, and under this
proposal, will not be permitted to be used for that purpose.
Thus, the proposed use of antimicrobial treatments does not imply a
change in current FSIS policy regarding removal of physical
contaminants from meat and poultry carcasses. Fecal, ingesta, or milk
contamination on cattle carcasses must be removed by trimming. Wash/
trim studies are underway to determine the best way to remove these
visible contaminants. Public comment and discussion, including peer
review, of the data from these studies will be solicited and reviewed
as part of the Agency's evaluation and decisionmaking process on this
issue.
FSIS policy concerning visible contaminants on poultry continues to
require carcasses to be free of fecal contamination before entering the
chillers. The process control program set forth in the current
regulations provides Finished Product Standards (FPS) for poultry where
feces are one of the ``nonconformances'' that are summed with other
nonconformances to determine compliance with the standard (9 CFR
381.76). This is only a measure of the presence of this nonconformance,
not a tolerance. Finished poultry carcasses are subject to the same
requirements as are finished livestock carcasses, with no visible fecal
matter permitted. Because of confusion on this point, FSIS is proposing
to remove feces from the FPS for poultry to make clear the current
policy that there is no tolerance for feces.
The Agency's proposal to codify the zero tolerance policy for fecal
contamination was one of a number of recently proposed changes to its
poultry inspection regulations, designed primarily to address concerns
about pathogens (July 13, 1994, 59 FR 35639). The proposal drew more
than 400 comments. Although many critical comments were received, a
great majority of the comments on point supported the use of
antimicrobial treatments and removal of feces from the Finished Product
Standards. Because these two elements of the July 13 proposal are
incorporated in this proposal, comments are again being solicited. This
does not, however, preclude completion of the July rulemaking on these
two issues and the issuance of final rules based on that proposal.
One part of the July proposal that was criticized in the comments
is the requirement that the antimicrobial treatment be limited to
application prior to the chilling or cooling system. Some commenters
indicated that certain antimicrobial treatments for use in the chilling
or cooling systems are more effective than treatments applied before
this point. Additionally, some held that certain post-chill treatments,
such as irradiation, may provide a more effective treatment option.
FSIS's intent was, and is, that poultry entering chill tanks be as
clean as possible. However, FSIS invites comments on whether mandated
antimicrobial treatments should be restricted to pre-chill application,
as proposed above.
Irradiation is another issue related to this proposal on
antimicrobial treatments. Irradiation is statutorily defined as a
``food additive'' under the Federal Food, Drug, and Cosmetic Act
(FFDCA) and thus its safety is evaluated by FDA, which must approve its
use as a food additive in a regulation specifying safe and lawful
conditions of use. FDA has approved irradiation for use in controlling
foodborne pathogens on uncooked poultry (21 CFR 179.26), and FSIS has
promulgated regulations under the PPIA specifying inspection
requirements for establishments using that process (9 CFR 181.149). FDA
currently is considering a petition to permit use of irradiation to
control pathogens on uncooked meat. Irradiation is not being considered
an [[Page 6791]] antimicrobial treatment for purposes of this proposal
because irradiation facilities are to date extrinsic, stand-alone
operations that cannot easily be integrated into a slaughter
operation--the focus of the present effort. Furthermore, although
irradiation has been shown to be a highly effective pathogen control
mechanism, it is a capital-intensive process largely unavailable to
most inspected slaughter establishments. Notwithstanding these
considerations, firms would be able to use irradiation on raw poultry
under existing regulations, in addition to the antimicrobial treatments
now being proposed.
Approved Antimicrobial Treatments
A number of methods for reducing the number of bacteria that may be
on carcasses have been suggested, e.g., exposing the carcass to hot
water, chemical sanitizers, such as chlorine or trisodium phosphate
(TSP), and short chain food grade acids, such as lactic, acetic, and
citric acids.
Antimicrobial treatments currently permitted by FSIS are techniques
involving the rinsing of carcasses with a wash or spray, normally using
either hot water or a solution of water and a substance approved by
FSIS for that use on the basis that it has been found to be effective
and its use is consistent with applicable FDA regulations governing
food additives. Some mechanical process modifications currently in use
have been shown to enhance the results of rinsing procedures.
Countercurrent scald tanks with a postscale spray have been shown to be
effective in reducing bacterial levels on poultry carcasses.
Equipment and utensils used in preparing or handling meat and
poultry products in inspected establishments are subject to inspection
to ensure that their use will not result in adulteration or misbranding
of the finished product. To promote efficiency and uniformity in this
element of FSIS's inspection duties, FSIS reviews newly developed
equipment and utensils intended for use in inspected establishments and
publishes a listing of equipment and utensils found to be acceptable
for that use (9 CFR 380.5, 381.53). Establishments and other
manufacturers of mechanical devices designed for antimicrobial
treatments, such as scalding tanks and spray cabinets and devices, must
obtain approval of their equipment from the Facilities, Equipment and
Sanitation Division, Science and Technology, Food Safety and Inspection
Service, U.S. Department of Agriculture, Washington DC 20250. A copy of
the current list of approved equipment and utensils also is available
from that office.
The use of an antimicrobial treatment on raw meat and poultry
carcasses would reduce the levels of bacteria on the product, but it
would not eliminate the need for continued careful handling of those
products before and after the antimicrobial treatment. The following
are available antimicrobial treatments that FSIS tentatively concludes
could satisfy its proposed requirements for a mandatory antimicrobial
treatment. FSIS invites comment on each of these.
(a) Hot water. Hot potable water or steam may be used to reduce
microbiological counts on meat and poultry. Washing carcasses with hot
water has been shown to be effective in reducing the level of bacteria
on carcass surfaces.
The decontamination of carcasses using hot water has a number of
advantages. These include: (1) reliable reduction of contaminants, (2)
removal of loose extraneous material, (3) no impairment of meat
properties, (4) no chemical reaction with equipment, such as the
corrosive effects associated with acetic acid, (5) no disposal
problems, and (6) readily available and easily accomplished.
Disadvantages with hot water sprays include: (1) the need for
greater pumping pressures, (2) less recoverable heat energy from the
outlet water steam, (3) the likelihood of nozzle blockage if water is
recirculated, and (4) the production of mist which condenses on
surfaces in the vicinity of the cabinet if baffles are not used.
Scientific studies over the course of the past twenty years have
investigated whether the use of hot water (74 deg.-95 deg.C, 165 deg.-
201 deg.F) instead of the commonly used lower water temperatures
(30 deg.-35 deg.C, 85 deg.-95 deg.F) can reduce the general microflora
of aerobic mesophiles present on the carcass, including members of the
family Enterobacteriaceae. This taxonomic group includes some of the
most important foodborne pathogens. Hot water rinses have been shown to
be effective against a number of foodborne pathogens including
Escherichia coli O157:H7, Salmonella, Yersinia enterocolitica, and
Listeria monocytogenes. Quantitative studies assessing the impact of
hot water treatment on the survival of E. coli O157:H7 have suggested
that it can reduce the levels present on the carcasses by 84-99.9
percent, as well as the number of contaminated carcasses. Other studies
with E. coli biotype 1 (E. coli O157:H7 is one of hundreds of E. coli
serovars) have indicated that hot water can reduce levels by 99-99.9
percent.
The effects of hot water washing are dependent on two separate
mechanisms. The first is simply the physical washing action of the
rinsing. This can account for a significant portion of the overall
effect, particularly if the bacteria are only loosely attached to the
carcass surface. In addition, the thermal effects of the elevated
temperatures produce some degree of heat inactivation. As with any
thermal processing, the extent of the inactivation will be directly
proportional to both the duration and temperature of the heating
material (i.e., water temperature). A hot water rinse can achieve up to
a 99.9 percent (3 log) decrease in the levels of various pathogenic and
non-pathogenic bacteria. It potentially can achieve up to a 99.9
percent reduction in E. coli O157:H7.
Hot water sprays are most effective when applied in a manner that
raises the water film on the surface of the carcass (surface
temperature of the carcass) to 82 deg.C (180 deg.F) for 10 seconds.
Exposure of beef carcasses to 80 deg.C (176 deg.F) water results in a
greying of the meat surfaces; however, the color returns to its normal
appearance after chilling. When the carcass surface is exposed to
82 deg.C (180 deg.F) for more than 20 seconds, tissue discoloration
becomes permanent.
Researchers have tested the effectiveness of hot water using sprays
or dips and using decontamination cabinets, with hot water only and
with chemical sanitizers.
One study found that treating beef carcasses with a steam and hot
water spray at 176 deg.F-205 deg.F (80 deg.C-96 deg.C) for 2 minutes,
sprayed from one foot (25 cm.), lowered bacterial numbers. A volume of
18.9 liters of water was sprayed for each carcass. Some discoloration
of the carcass surface occurred initially, but normal color returned
after cooling for 24 hours.
Another study found a hot water treatment of beef and mutton
samples inoculated with E. coli more effective in reducing bacterial
numbers than a naked flame, steam chamber, steam ejection, or washing
with water at 37 deg.C (99 deg.F). When hot water temperatures were
below 60 deg.C (140 deg.F), no significant color change was noted.
Above 85 deg.C (185 deg.F), the color change was marked and permanent.
Permanent color changes of the surface tissues caused by using water at
95 deg.C (203 deg.F) for three minutes did not extend more than about
0.5 mm below the surface. Temperatures of 70 deg.C (158 deg.F) and
above gave at least a two log (99 percent) reduction of inoculated E.
coli on samples. [[Page 6792]]
The hot water spray cabinet used on lamb carcasses had water
leaving the nozzles at 95 deg.C, but the temperature of the water
reaching the carcass could not be raised above 74 deg.C (165 deg.F).
They were able to obtain a 99 percent decrease in inoculated E. coli at
all sites when sheep carcasses were immersed in 80 deg.C (176 deg.F)
water for 10 seconds. Immersion for 30 seconds gave little extra kill
of inoculated bacteria. In-plant immersion tests on carcasses that had
not been inoculated showed a 98 percent reduction in bacterial numbers.
Researchers have found that pouring hot water at 169 deg.F
(77 deg.C) on beef (tissue slices) and mutton (carcass) samples for 10
seconds destroyed more than 99 percent of E. coli and Salmonella
inoculated (106.5/cm\2\) onto the samples. Tissues surfaces were
not permanently discolored. When beef slices (2.5 cm thick) swabbed
with bacterial culture were exposed to hot water (60 deg., 65 deg.,
70 deg., 80 deg., 90 deg.C) for intervals of 10, 30, 60, and 120
seconds, it was found that the time of exposure was not a factor, but a
progressive decrease in E. coli counts from >10\1\ at 60 deg.C to
>10\4\ at 90 deg.C was noted. Coliform and aerobic mesophilic bacteria
counts on six naturally contaminated sheep carcasses were reduced from
100 cells/cm\2\ to below detectable limits and 8,500 to 310 cells/cm\2\
respectively.
A 1979 study applied cold water (16 deg.C, 60 deg.F)(<14 kg/cm\2\),
hot water 76 deg.C-80 deg.C [168 deg.C-176 deg.F])(14 kg/cm\2\), and
steam (95 deg.C) to previously frozen beef plate strips. Treatment with
cold water alone reduced the counts by about one log. Steam alone only
reduced the count by 0.06 log. Initial reduction in counts by hot water
alone was 2.0 log. Samples held at 3.3 deg.C were cultured for several
days after treatment. After an initial lag phase of less than a day for
samples treated with cold water or steam, the rates of bacterial growth
were greater on the treated samples than on untreated controls. By the
fifth day the aerobic plate counts for steam and cold water treated
samples exceeded the aerobic plate count on the control samples.
Presumably this was due to the greater surface moisture from the
treatment. The rate of bacterial growth on samples treated with hot
water was similar to that on controls, but the initial 2-log difference
was maintained through 12 days of storage resulting in nearly 5
additional days for counts to reach 10\8\/cm\2\.
A 1981 study reported that lamb carcasses sprayed with hot water at
temperatures >169 deg.F (77 deg.C) caused significant decreases (1.0
log10/cm\2\) in APC. As temperature was increased the reduction in
bacterial numbers observed by spray washing was increased.
Another researcher used a deluge method instead of conventional
pressure spraying. Advantages cited include: construction simplicity,
cheaper running cost, and greater reduction in bacteria. However,
unlike spray decontamination, coverage of the abdominal and thoracic
cavities was only about 65 percent. He found a significant (<0.05)
linear relation between the log reduction in inoculated E. coli and
average water film temperature which varied with exposure time
immediately after treatment. Longer exposure (20 sec vs 10 sec)
produced significantly greater reduction at higher temperatures
(44.5 deg., 66.0 deg., 74.2 deg., 83.5 deg.C). There was no significant
growth of E. coli between 24 and 48 hours, which is consistent with the
findings of several other researchers. After chilling for 48 hours,
sides exposed to 83.5 deg.C had a slight and apparently permanent
bleaching of the fat and meat tissue in the area of the upper thoracic
cavity.
In a 1993 study, carcasses were sprayed with 2 liters of hot
(95 deg.C) water for 40 seconds with the intent of raising the meat
surface temperature to 82 deg.C for 10 seconds before final wash and
after final wash. The apparatus was designed to raise the temperature
within 30 seconds and maintain it at 82 deg.C for 10 seconds. Culture
samples taken from hot water-treated carcasses before final wash had a
mean log10/cm\2\ of 1.1 while controls had log10/cm\2\ of
2.4. Culture samples taken from hot water-treated carcasses after the
final wash had a mean log10/cm\2\ of 1.5 while controls had
log10/cm\2\ of 2.3. It was unclear why a greater reduction in
bacterial numbers occurred when carcasses were sprayed with hot water
before the final carcass rinse. A 15-20 minute elapsed time between hot
water and final wash may have allowed more bacterial attachment to take
place. The volume of the spray and the size of droplets were found to
have a profound effect on the temperature of the water contacting the
carcass surface.
In view of this research, FSIS is proposing that hot water
treatments used to meet the intent of this regulation be applied such
that the temperature of the water at the surface of the carcass is
165 deg.F ( 74 deg.C) for 10
seconds. If applied by a spray, this is likely to require that the
water be heated to a somewhat higher temperature. The hot water would
have to contact all carcass surfaces. Other combinations of time and
temperature of hot water also may be effective. FSIS would like
comments on this point.
FSIS considers the final beef carcass wash to be an appropriate
point at which to apply hot water as an antimicrobial treatment. The
final carcass wash occurs at the end of the slaughter and dressing
process, after trimming and FSIS postmortem inspection is completed.
The final carcass wash is usually the last step in the dressing process
before the carcass enters the cooler for chilling. The final carcass
wash removes blood, bone dust, hair, dirt, and other accidental
contamination. On November 1, 1994, FSIS announced that hot water
rinses will be allowed at the final beef carcass wash without prior
approval. An establishment wishing to apply hot water to beef carcasses
at the final wash no longer must obtain prior approval by FSIS.
However, FSIS notes that a hot water wash used pre-evisceration might
also meet the intent of this regulation and therefore has the potential
advantage of removing/destroying bacteria before they have had time to
become tightly attached to carcass tissues. FSIS invites comments on
whether the use of hot water wash to satisfy the proposed requirement
of an antimicrobial treatment should be limited to the final carcass
wash or should be permitted at other stages of the slaughter and
dressing process.
A list of studies on various methods of applying hot water to meat
and poultry carcasses is on file in the FSIS Docket Clerk's office, and
is available from the Director, Slaughter Inspection Standards and
Procedures Division, FSIS, U.S. Department of Agriculture, Washington,
DC 20250. FSIS welcomes additional data on the effectiveness of hot
water as an antimicrobial treatment, especially regarding the
effectiveness of varying temperatures and times of exposure.
(b) Lactic, acetic, and citric acid solution sprays.
Lactic, acetic and citric acids are weak acids that have long been
consumed by humans in a variety of foods. They occur naturally (e.g.,
citric acid in limes), have been added in the processing of a broad
variety of foods (e.g. acetic acid in mayonnaise), and develop in the
fermentation of foods (e.g., lactic acid in cheese).
FDA lists acetic acid as Generally Recognized As Safe (GRAS) as a
direct food substance in 21 CFR 184.1005 if used at levels not
exceeding current good manufacturing practice (CGMP). The acetic acid
listing specifies that the CGMP results in a maximum level in meat of
0.6 percent as served. While the use of acetic acid on fresh meat was
not reviewed by the Select Committee on GRAS Substances in reaching its
[[Page 6793]] conclusion on the safety of food use of acetic acid, FDA
believes that use of acetic acid as proposed in this rule will result
in residual levels on product ``as served'' below the most restricted
use levels specified in Sec. 184.1005 for acetic acid (FDA November 29,
1982), 0.15 percent for ``all other food categories.''
Lactic acid is approved as GRAS at 21 CFR 184.1061 with no
limitations other than good manufacturing practice. In addition, lactic
acid is listed for use as an antimicrobial agent in foods, also at a
level not to exceed good manufacturing practice.
Citric acid is listed for multiple purpose use in 21 CFR 182.1033,
when used in accordance with good manufacturing practices.
In addition, sections 318.7(c)(4) and 381.147(f)(4) of the
regulations (9 CFR 318.7(c)(4) and 381.147(f)(4)) currently allow the
use of acetic, lactic, and citric acids as acceptable ingredients in
various meat and poultry products when used as acidifiers or as
esterifiers in margarine. Citric acid may also be used as an
anticoagulant, a flavoring agent, and a synergist at various levels in
various meat and poultry food products. Citric acid is acceptable as a
curing accelerator to speed up color fixing or preserve color during
storage of cured pork and beef cuts and cured comminuted meat food
products.
In 1990, FSIS determined that lactic, acetic and citric acids can
be safely and effectively used as antimicrobial treatments on meat and
poultry carcasses and by-products during slaughter and dressing
procedures. That determination was based on an extensive review of the
scientific literature on methods of reduction of bacteria on meat
surfaces.
During the past twenty years the use of organic acid rinses to
reduce spoilage and pathogenic microorganisms on foods has been studied
extensively. Numerous researchers have demonstrated that organic acid
rinses can produce a significant reduction in bacterial levels on the
surfaces of meat and poultry. Although most of these studies have been
conducted under laboratory conditions, there have been some studies
that have specifically assessed the efficacy of these antimicrobial
systems under production conditions. Also, some of the laboratory
research has been conducted under simulated in-plant conditions.
The results achieved in the various research trials have not been
unequivocal, in part because the effectiveness of the compounds is
dependent on their interactions with a number of other factors. Some of
the factors that have been identified include (1) pre- versus post-
rigor tissue, (2) pre-washing prior to treatment, (3) tissue type, (4)
method for acid delivery, (5) droplet size, (6) flow rate/pressure, (7)
temperature, (8) pH, (9) contact time, (10) bacterial species, (11)
type of acid, (12) buffering capacity, and (13) moisture content.
Differences in study design, especially factors such as methods used to
collect tissue samples and analyze for bacterial species or the
preadaptation of bacterial cells to an acid environment, affect
results. Interpretation of research results can also be confounded by
difficulty in obtaining valid microbiological data because of large
carcass to carcass variations, as well as differences in microflora
associated with different slaughter facilities, carcasses, and sample
sites on individual carcasses.
The literature suggests it is important to lower the pH of the meat
surface if bacteria are to be controlled effectively by using an
organic acid. Most organic acids are effective only at low pH values of
pH 5.5. Apparently the anion exerts some effect on bacteria at pH
values of pH 5.5. The pH affects the extent of dissociation.
Undissociated weak acids are more effective than the dissociated form
and dissociate to produce acidification of the cell interior.
Overall, the available scientific data indicate that washing of
carcasses with organic rinses or sprays can achieve a 90-99.9 percent
reduction in levels of spoilage bacteria (e.g., Pseudomonas
fluorescens) though in some cases the reductions were not statistically
significant and in others no improvement was noted. In addition, acid
sprays and dips have also been shown to decrease the levels of specific
pathogens, as well as the incidence of carcasses that are positive for
specific pathogens. This includes activity against Salmonella spp.,
Staphylococcus aureus, Campylobacter jejeuni, Yersina enterocolitica,
and Listeria monocytogenes. However, these techniques do not and cannot
be expected to completely inactivate or eliminate pathogens.
One of the bacterial species that appears to be among the more
resistant to the effects of organic acids is E. coli O157:H7. A number
of investigators have found that O157:H7 has a relatively high acid
tolerance. Again, the extent of inactivation achieved with E. coli
O157:H7 has varied among the various studies. For example, one
researcher found that E. coli O157:H7 reductions were similar to those
observed for Salmonella spp. and Listeria monocytogenes, with up to a
99.9 percent reduction in the levels of all three bacteria from
inoculated tissues and concluded that an acetic acid carcass sanitizer
could be used as an effective method to control these bacterial
pathogens. Conversely, another reported that up to 1.5 percent acid
treatments did not appreciably reduce E. coli O157:H7, whether at
20 deg. or 55 deg.C and ``was of little value in disinfecting beef of
E. coli O157.'' It has been reported that there are differences among
E. coli O157:H7 isolates in relation to their acid tolerances. These
investigators also found that inactivation was dependent on acid
concentration (5 percent gave greatest reductions), and tissue type
(reductions greater on adipose tissue than lean). Some investigators
have suggested that lactic acid is more effective than acetic or citric
acid against E. coli. It has been suggested that the primary
determinants of effectiveness were the pH achieved at the surface of
the carcass and the corresponding period of exposure.
Organic acids apparently are more effective when applied as soon
after slaughter as feasible, and when they are at elevated temperatures
(53 deg.-55 deg.C). The bacteria found on a carcass soon after
slaughter are believed to be present in a water-film on the surface
and, therefore, are relatively easy to remove, contrasted with bacteria
that have become attached to the carcass surface itself by the time
chilling is complete and are therefore more difficult to remove.
Overall, organic acid rinses appear to be a generally effective
antimicrobial intervention that have several distinct advantages.
Specifically, the advantages include: (1) the technique can achieve up
to a 99.9 percent (3 log) decrease in the levels of specific pathogenic
and non-pathogenic bacteria; (2) the effectiveness of the application
can be readily monitored; (3) the technology can be implemented through
a relatively straightforward modification of existing equipment; and
(4) this is a process for which there are no apparent ``tradeoffs'' in
relation to other risks or negative attributes (e.g., the presence of
residues or the need to eliminate environmentally sensitive
byproducts). The primary disadvantage is that the effectiveness of
acetic acid rinses against E. coli O157:H7 is not as great as against
other pathogens, and at least some studies indicate that these rinses
may not achieve the results desired.
In 1992, FSIS issued a directive (FSIS Directive 6340.1, 11/24/92)
that provided guidance to FSIS employees on conditions of use, and how
to evaluate and respond to livestock establishments' requests for
approval of pre-evisceration carcass spray systems using an acid spray
to reduce the [[Page 6794]] microbial population and retard further
microbial growth on livestock carcasses. For beef carcasses, FSIS also
recently authorized establishments to use acetic, citric, or lactic
acids on inspected and passed carcasses before chilling in conjunction
with the final wash without prior FSIS approval on an establishment-by-
establishment basis.
FSIS is proposing that, to satisfy the proposed requirement for at
least one antimicrobial treatment, acetic, lactic, or citric acid could
be applied to carcass surfaces prior to entering the cooler. FSIS is
preparing to propose in a separate rulemaking that these organic acids
be listed, as approved antimicrobial agents, in 9 CFR 318.7 and 381.147
for livestock and poultry uses, respectively, in a solution of 1.5-2.5
percent concentration and in such a fashion that all carcass surfaces
would be contacted.
FSIS invites comments on whether the use of these acids to satisfy
the program requirements for an antimicrobial treatment should be
limited to post-inspection application in conjunction with the final
carcass wash or should be permitted at earlier stages of the slaughter
and dressing process, such as after skinning but before evisceration
and completion of postmortem inspection by FSIS inspectors, or during
chilling. FSIS also invites comment on whether organic acid sprays
should be considered an acceptable antimicrobial treatment in beef
slaughter establishments in light of the reported acid-resistance of E.
coli O157:H7, which is a pathogen of particular public health concern
in beef.
A list of studies on the application of organic acids on meat
carcasses is on file with the FSIS Docket Clerk and may be obtained
from the Director, Slaughter Inspection Standards and Procedures
Division, FSIS, U.S. Department of Agriculture, Washington, DC 20250.
(c) Trisodium phosphate (TSP). The application of TSP to raw
poultry carcasses by spraying or dipping with a solution of water and
food grade TSP was recently approved by FSIS. Trisodium phosphate (TSP)
is listed in the FDA regulations as GRAS for multiple purpose use, in
accordance with good manufacturing practices. FDA has affirmed that
application of TSP to raw poultry carcasses is consistent with the GRAS
listing for TSP. Additionally, TSP (sodium phosphate, tribasic) is
listed in the Food Chemicals Codex III (1981).
FSIS has granted interim approval for use of TSP at pre-chill and
post-chill locations, and has begun rulemaking procedures to include
this compound in 9 CFR 381.147(f)(4), Table 1, under the new class of
substances to be called ``antimicrobial agents'' (59 FR 551). TSP
reduces bacterial levels, including pathogenic bacteria, on raw poultry
carcasses when applied by spraying or dipping the raw poultry carcasses
for up to 15 seconds post-chill or for up to 30 seconds pre-chill with
an 8-12 percent solution of TSP in water. TSP may be applied to raw
chilled poultry as a solution maintained at 45 deg.F-55 deg.F, and to
raw poultry as a solution maintained at 65 deg.F-85 deg.F.
Industry, university, and Agriculture Research Service studies
demonstrate TSP induced reductions in carcass Salmonella levels ranging
from 90 to >99.9 percent (1.2 to 8.3 log10). The higher Salmonella
reductions were associated with pre-chill TSP applications. Mean
carcass Salmonella prevalence was reduced from up to 23 percent to
approximately 1 percent. Industry studies demonstrate median reductions
in carcass Enterobacteriaceae and E. coli levels of approximately 99.5
percent (2.5 log10). In a study conducted by an independent
laboratory, Campylobacter average prevalence was reduced from 100
percent to 30 percent with mean numerical reductions of >99.9 percent
(4 log10) following TSP application to raw, unchilled poultry
carcasses. TSP application to raw poultry, under the above stated time,
concentration, and temperature conditions of use, therefore, causes
statistically significant reductions in these most common gram negative
pathogens associated with raw poultry.
As part of the poultry chilling process, poultry carcasses may gain
moisture up to the levels permitted in 9 CFR 381.66(d). Poultry
establishments using TSP are not exempted from the moisture absorption
and retention limits contained in 9 CFR 381.66(d). To preclude the
potential for economic adulteration of poultry carcasses as a result of
TSP treatments, federally inspected establishments applying TSP to raw
poultry carcasses will include the TSP application in their washing,
chilling, and draining method as outlined in 9 CFR 381.66(d)(8).
Commercial use of TSP has only recently begun in some poultry
establishments. It is not yet widely used. A commercial study
investigating the efficacy of TSP in reducing bacterial levels on beef
carcasses is in progress.
Federally inspected establishments using TSP as an antimicrobial
agent on raw poultry have consistently met local and State effluent
phosphate discharge requirements by making minor modifications to their
effluent flocculation methods.
FSIS is proposing to permit TSP to be applied to poultry carcass
surfaces at any point prior to entering the chiller as one means to
meet the proposed requirement for an antimicrobial treatment. FSIS
intends to propose in another rulemaking a regulation to list TSP in
part 381.147(f)(4), Table 1, as an approved antimicrobial agent. TSP
would be applied in a solution of 8-12 percent concentration in such a
fashion that all carcass surfaces would be contacted.
A list of studies done on the application of TSP to poultry
carcasses is on file in the FSIS Docket Clerk's office, and is
available from the Director, Slaughter Inspection Standards Division,
FSIS, U.S. Department of Agriculture, Washington, DC 20250.
(d) Chlorinated water. The washing of carcasses with chlorinated
water to reduce the amount of spoilage and pathogenic microorganisms on
carcasses is a longtime practice in the poultry industry. As early as
1951, researchers noted the effectiveness of in-plant chlorination in
lowering bacteria counts on product, increasing shelf life, reducing
odors in the establishment, and reducing slime on equipment.
Chlorine is now used in most poultry establishments, primarily in
chill water, to minimize bacterial cross-contamination and as an
effective sanitizing agent on facilities and equipment, usually at
FSIS-sanctioned levels of 20 to 50 parts per million (ppm) available
chlorine.
A FSIS study published in 1992 showed significant microbial
reductions on raw chicken carcasses and giblets immersed in chlorinated
chill water. In this study, the addition of 25 ppm of chlorine in the
chill water resulted in a significant decrease in aerobic plate counts,
Enterobacteriaceae, and E. coli. Some reduction also occurred without
chlorine in chill water indicating that chilling carcasses in this
manner actually reduces the bacterial load on carcasses. The effect on
Salmonella was a reduction in the amount of cross-contamination.
Without chlorine, the percent of carcasses exiting the chiller with
Salmonella versus the percent going in increased significantly. With
the addition of chlorine, the differential was not significant. The
conclusion was that chlorine aids in the control of cross-contamination
in the chillers.
Chlorinated water has long been recommended for reducing bacteria
in poultry processing establishments. In one study 34 ppm chlorine
reduced salmonellae in broiler chill water to non-detectable levels,
and resulted in significant reductions (10-13 percent) in
[[Page 6795]] the incidence of Salmonella on the carcasses.
A 1968 study demonstrated that by incorporating chlorine (20 ppm)
into sheep carcass wash water, bacterial numbers were reduced
significantly, but usually less than one log. Another study showed
increased reductions in bacterial numbers were obtained as the chlorine
level in water used to wash lamb carcasses was increased up to 357 ppm.
Another researcher observed similar reductions when lamb carcasses were
washed with 150 and 250 ppm chlorine. A study in 1977 found that up to
log100.7/cm2 reduction could be obtained by using water
containing 200-250 ppm chlorine to spray beef tissue.
An initial mean reduction of 0.31 log on beef tissue has been
achieved by treating it with a 200-250 ppm chlorine wash. FSIS
considers the application of chlorine at levels up to 30 ppm on
poultry, including giblets and salvaged parts, and in poultry chiller
water, to be prior sanctioned under the food additive provisions of the
Federal Food, Drug, and Cosmetic Act. The comparable use of chlorine in
sprays applied to livestock carcasses is also a practice that has long
been permitted by FSIS.
The vast majority of poultry establishments and a growing number of
meat establishments apply chlorine solutions during slaughter and
processing. To meet the intent of the regulation, FSIS would allow the
application of 20-50 ppm chlorine in the final wash for livestock and
poultry carcasses.
Some environmental risks have been associated with the use of
chlorine, most significantly from the formation of byproducts of
chlorine reactions with organic compounds in water. The trihalomethane
(THM) byproducts are the current focus of regulation of drinking water
chlorination by the Environmental Protection Agency under the Safe
Drinking Water Act. It has been reported that there is an association
between long-term exposure to chlorinated drinking water and a 9-15
percent higher incidence of human bladder and rectal cancer. The
researchers were of the opinion, however, that the public health risks
from microbial contamination in unchlorinated water ``greatly exceed''
the risks of possible increased incidence of bladder and rectal
cancers.
Because one of the THMs, chloroform, is an animal carcinogen, FSIS
contracted with a private firm to perform a quantitative cancer risk
assessment on chloroform residues recovered from the fat and skin of
whole broiler chickens purchased at retail. Based on this assessment,
estimates of additional lifetime cancer risk in the population from
consumption of chloroform residues in chicken ranged from two in one
billion (2 x 10-9) to five in 100 million (5 x 10-8) for
fat, and from two in one billion (2 x 10-9) to four in 100
million (4 x 10-8) in skin based on estimates of chicken
consumption. These are well below the level of one in one million (1
x 10-6) additional lifetime cancer risk generally considered
negligible by EPA and FDA in their regulation of pesticides and other
chemicals, such as animal drug residues.
FSIS believes that these extremely small risks are clearly
outweighed by the public health benefits of chlorine in reducing
microbial contaminants on product. FSIS permits the use of nitrites in
cured products on a similar basis; the antimicrobial safety benefits
provided consumers by its use greatly outweigh the very small risk
posed by possible carcinogenic byproducts.
At the request of FSIS, ARS is studying the possible risks from any
mutagens that might be formed with the use of chlorinated poultry
chiller water. Early phases of this study indicate only that very low
levels of mutagenic compounds are associated with chlorinated poultry
chiller water and that they increase as the chlorine levels used
increase.
FSIS will continue to monitor closely all data on the safety of
chlorine when used on carcasses as an antimicrobial agent, and will
continue to reevaluate the risks and benefits associated with approved
use.
FSIS invites comments on the risks and benefits of chlorine used to
reduce and control microbial levels on meat and poultry products.
Product for Export
Application of antimicrobial treatments under this proposed
regulation might interfere with the export of the products. This may be
especially true for products from carcasses treated with certain
chemicals. For example, Canada limits the use of chlorine on poultry
products to a maximum of 20 ppm, and chlorine is not permitted at all
in some of the countries of the European Union.
Therefore, so as not to interfere with the export of meat and
poultry products, and enable companies to meet the expectations of
their customers, FSIS is proposing to exempt from antimicrobial
treatment product designated for export only. This exemption would
apply only to product being prepared for export to a country which will
not accept product exposed to the antimicrobial treatment installed in
the establishment under this proposed regulation. Exempted export
product must be properly identified, segregated, and labeled. FSIS
invites comments on this proposed exemption.
3. Temperature Controls
Temperature is one of the primary factors affecting bacterial
multiplication; the lower the temperature, the more slowly the
multiplication occurs. Carcass surfaces become contaminated with
bacteria during the slaughter and dressing procedures, while carcass
interiors remain uncontaminated. Rapid cooling of carcasses prevents
the multiplication of pathogenic bacteria on the carcass surface, and
thus reduces consumer exposure and risk.
FSIS has concluded that most raw meat and poultry products must be
rapidly chilled to 50 deg.F and then maintained at 40 deg.F or below to
minimize the risk to public health from pathogens on those products.
The technology needed to achieve the proposed chilling standards is
readily available and for the most part already installed in
establishments. The change being proposed is that appropriate time-
temperature controls for handling raw product, already generally
adhered to by many establishments, will become mandatory for all
establishments.
Accordingly, a new section 318.25 would be added to the meat
inspection regulations requiring that establishments cool livestock
carcasses and raw meat products so the products reach a temperature of
50 deg.F or below within specified time periods and maintain cooled
carcasses and raw meat products at 40 deg.F or below throughout
handling, holding, and shipping to other official establishments, with
certain exemptions. One exception is for raw product going directly
into processing that includes a pathogen-lethal heating step, and
thereby results in a ``ready-to-eat'' product. Raw product would be
partially exempt from the time-temperature requirements applying to
fresh carcasses because when product enters a ready-to-eat process,
other time-temperature controls applicable to the raw ingredients would
apply. Additionally, the processing treatment required for ready-to-eat
products stabilizes the product by killing both pathogens and spoilage
bacteria. Another exception to the proposed cooling requirements is for
``hot-boned'' product, that is, muscle tissue removed from the carcass
before chilling, which would have to be cooled within 5 hours (meat) or
1.5 hours (poultry) to a surface temperature of 10 deg.C (50 deg.F).
Any edible parts removed from the carcass and not to be heat processed
directly, e.g., livers, hearts, and heads with cheek meat, must
[[Page 6796]] enter a chiller within 1 hour and chill at the same rate
as carcasses.
This proposal also would amend section 381.66 of the poultry
regulations so they are substantially consistent with the proposed meat
inspection regulations regarding temperature and chilling requirements.
Section 381.66 currently requires that all poultry slaughtered and
eviscerated in an official establishment be chilled immediately after
processing so that the internal temperature is reduced to 40 deg.F or
below within a time period appropriate to the size of the carcass. It
further requires that eviscerated poultry to be shipped from the
establishment in packaged form be maintained at 40 deg.F or below,
with certain exceptions. Section 381.66 would be amended to include new
time/temperatures requirements, to mandate corrective actions when
time/temperature controls fail, and to eliminate other provisions
inconsistent with those being proposed for meat. FSIS believes 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.
Time-Temperature Requirements
FSIS is proposing that establishments cool the surface of meat
carcasses to 50 deg.F or below within 5 hours and to 40 deg.F or
below within 24 hours from the time that carcasses exit the slaughter
floor. This cooling rate is based on the best estimate of what is
needed to minimize multiplication of pathogenic organisms and what is
achievable in a well-controlled meat establishment. Controlling the
surface temperature also ensures that the interior is cooling at a
reasonable rate.
Carcasses and raw meat products would be required to be maintained
at an internal temperature of 40 deg.F or below during handling,
holding, and shipping. FSIS considered a higher temperature limit
because at temperatures below 50 deg.F, spoilage bacteria generally
multiply faster than pathogens. Thus, meat below 50 deg.F generally
will spoil before excessive pathogenic bacterial multiplication can
occur. For example, spoilage bacteria, such as Pseudomonas spp.,
Pediococcus spp., and Lactobacillus spp., not only increase faster than
pathogenic bacteria, below 50 deg.F, but some also form inhibitory
compounds. However, FSIS rejected a higher temperature limit and is
proposing 40 deg.F because: (1) The lower temperature provides an
additional margin of safety against the multiplication of pathogenic
bacteria, (2) 40 deg.F has long been the maximum temperature
recommended, as set forth in Agriculture Handbook No. 412; (3) the U.S.
industry generally uses much lower temperatures (e.g., 30 deg.F (-1.1
deg.C) to retard spoilage as well); and (4) 40 deg.F would be the same
as the temperature currently required for chilling poultry products (9
CFR 381.66).
Except for hot-boning operations, where muscle tissue is removed
from the carcass before cooling, FSIS is not proposing a set time to
attain an internal temperature of 40 deg.F. This is because, when the
surface temperature of a product reaches 40 deg.F within the proposed
24 hours and is maintained at that temperature, the laws of
thermodynamics ensure that the interior will cool to a safe temperature
within a reasonable time frame. Since carcass weight and composition
affect the interior cooling rate, a set time to an internal temperature
would be too strict for heavy carcasses and too lenient for light
carcasses.
There are additional reasons to use surface temperatures. First,
any bacterial pathogens on a fresh carcass are concentrated on its
surface. The deep tissue of carcasses, with few exceptions, is sterile.
Thus, the control point should be where the potential hazard exists.
Second, the surface is the most prudent place to measure temperatures.
Probing the deep muscle tissue of carcasses before they are fully
cooled could cause a public health problem by injecting any bacterial
pathogens on the surface into the sterile warm interior.
Hot-boned product, however, would be controlled by internal
temperature. Cutting into the carcass increases the probability of deep
tissue contamination due to tears in the muscle facia, flexing,
punctures, and additional handling. Therefore, the internal temperature
is the critical control point. And, since the integrity of the carcass
has been violated, the internal temperature is the appropriate
monitoring point.
The proposed cooling rates, holding temperature, and corrective
actions specified in the proposed rule are based primarily on the
thermodynamics of cooling meat and the effect of temperature on
bacterial multiplication. Further information on how these were
calculated is available in ``The Scientific Basis for Proposed Time-
Temperature Requirements,'' a paper on file in the FSIS Docket Clerk's
office and available upon request from Director, Processed Products
Inspection Division, FSIS, U.S. Department of Agriculture, Washington,
D.C. 20250.
This proposed rule would also require that carcasses and raw meat
products reach a temperature of 40 deg.F or below prior to leaving the
establishment. Requiring a temperature of 40 deg.F or below prior to
entering commerce provides added assurance that during transportation
the product will be maintained at 40 deg.F and bacterial
multiplication will be restricted. Carcasses or raw meat products are
permitted, however, to enter a ready-to-eat process at the
establishment, before being cooled to an internal temperature of 40
deg.F.
Slaughtering establishments would be required to begin cooling raw
meat products other than carcasses within 1 hour of removal of the
tissues from the carcass. Establishments generally remove raw meat
products, such as livers, hearts, heads, and cheek meat, before the
carcass exits the slaughter floor. These products have a history of
poor microbiological quality because the products are packed in boxes
before cooling or are moved to the cooler only after a delay. The
requirement that cooling of these products begin within 1 hour of
removal from the carcass would reduce the opportunity for pathogenic
bacterial multiplication and improve the microbiological quality of
these products. The cooling rate proposed for these products is the
same as that for the carcass surface--50 deg.F within 5 hours and 40
deg.F within 24 hours.
The method used to measure the surface temperature of a carcass or
a raw meat product would be at the discretion of the establishment.
Pressing the side of a temperature probe against the meat surface is
the easiest and most inexpensive method. Because air has low heat
capacity relative to meat, this method should give a good estimation of
the meat surface temperature. Shielding the probe from room air should
increase the measurement accuracy. For shielding, one suggestion is to
place two carcasses together and measure the contacting surfaces.
Shielding the probe from room air with a food contact material having
low heat conductance and capacitance, such as a dry sponge in a plastic
bag, after proper sanitizing, would also be effective.
The time-temperature profiles being proposed might be modified for
certain raw products if other factors such as dryness or acidity are
factored in. Therefore, it is possible that an establishment's
designated processing authority could develop alternative time and
temperature procedures for cooling, shipping, receiving, and, or
holding carcasses and raw meat products that would produce microbial
profiles equivalent to or better than those produced under the proposed
requirements. The Agency is therefore [[Page 6797]] proposing to allow
use of time and temperature limits equivalent to those specified in the
proposed requirements. Any such alternate procedures would, however, be
difficult to monitor for regulatory purposes. FSIS welcomes comment on
this point.
Written Plan for Meeting Time and Temperature Requirements
Establishments would be required to develop, implement, and place
on file a written plan for meeting the time and temperature
requirements either prescribed in this proposed rule or in alternative
procedures developed by a processing authority. The plan would include
the establishment's designated control points, i.e., the points within
an establishment's operation where temperatures would be measured;
monitoring procedures; records to be kept; standards for the control
points, including the cooling rate, holding temperature, and shipping
temperature; corrective actions to be followed if deviations occur,
including a system for separating and identifying noncomplying product;
and, when applicable, the name of the processing authority. The plan
would be required to be maintained at the establishment for as long as
the plan is being used by the establishment. The plan and monitoring
records must be made available to Program employees upon request.
Establishments would be required to monitor and record the maximum
temperature of a representative number of carcasses and raw meat
products periodically during the establishments' operation, as set
forth in their written plan for doing so. The frequency of monitoring
temperatures in a day's operation by establishments would vary,
depending on the size and type of an establishment's operations.
Establishments would include in this written plan the control points
and the frequency of measuring the temperatures in a day's operation.
Establishments would be required to use temperature measuring devices
readable and accurate to 2 deg.F (0.9 deg.C). The monitoring records
would be maintained for up to 6 months after the temperature
measurement, or until such time that may otherwise be specified by the
Administrator. Program employees would verify the frequency of
temperature measurement to ensure that the establishment's written plan
is being followed. Inspection personnel would also measure temperatures
at various control points and compare these temperatures with those
measured and recorded by the establishment.
Effect on Commercial Meat Manufacturing
Because raw poultry is already subject to chilling regulations, it
is expected that this proposed regulation primarily will affect meat
establishments.
Present commercial meat manufacturing and distribution practices
are diverse. Some establishments slaughter animals, prepare raw meats,
and process and ship ready-to-eat products. Others may only slaughter
and dress animals, debone meat, or prepare raw meats as ingredients for
ready-to-eat products. This proposed rule would cover all official
establishments that slaughter, receive, store, transport or otherwise
handle carcasses and raw meat products.
The following is a brief discussion of present commercial meat
manufacturing and distribution operations and how this proposal would
affect those operations.
(a) Slaughter establishments. Slaughter establishments receive live
animals and produce raw meat. The establishment's task is to remove the
animal's hide and viscera in a manner that results in meat with as few
bacteria as possible. This task is called ``sanitary dressing.'' After
dressing, establishments cool carcasses to retard the multiplication of
any pathogenic or spoilage bacteria.
The primary means of cooling is to move the carcass into a cold
room where the temperature and air movement reduce carcass temperature.
Some establishments use various procedures to enhance carcass cooling.
The carcass spray chill method increases the cooling rate through
direct heat absorption and enhanced evaporative cooling. The sprayed
water directly absorbs some carcass heat on contact then absorbs even
more when it evaporates. Spray chilling is also advantageous to the
manufacturer in that it reduces the amount of weight lost from the
carcass by evaporation. The disadvantage is that the increased surface
moisture facilitates multiplication of bacteria.
A related practice is hot-boning, which involves the removal of the
meat before the carcass is fully cooled. The advantage of hot-boning is
that the meat is reduced to smaller, more easily cooled pieces, and the
meat is available for processing sooner than if it were removed only
after the carcass is fully cooled. However, hot-boning poses a hazard
if exposed warm meat surfaces remain at warm temperatures long enough
to allow bacterial multiplication.
This proposal would permit any of these cooling procedures as long
as the proposed cooling temperatures and time periods are met.
(b) Shipping and receiving. Slaughter establishments may ship meat
food products in several forms, such as carcasses, cuts, manufacturing
meat, or ground meat. In the past 20 years, the geographic
concentration of raw meat processing has made boxed meat the primary
form in which raw meat is shipped. Boxed meat is often shipped in 60-
pound containers of boneless manufacturing meat, cuts, primal cuts, or
subprimal cuts.
However, establishments still ship carcasses and larger containers
of manufacturing meat weighing 500 pounds or more.
Processing establishments manufacture raw meat products, ready-to-
eat meat products, or both. Processing establishments that are not also
slaughter establishments must receive raw meat products from other
establishments. This proposed rule would affect such processing
establishments by requiring them to ensure that raw product received is
at the required internal temperature of 40 deg.F or below, and to
maintain the raw meat product ingredient at that temperature in
conformance with the proposed requirements.
This proposed rule would require that establishments cool the
carcasses and raw meat products to an internal temperature of 40 deg.F
or below prior to shipping such products to help ensure that, if the
products are shipped to other official establishments, the products
arrive at the receiving establishments at an internal temperature of 40
deg.F or below.
The shipping establishment would be required to record the date and
time of shipment on the waybill, running slip, conductor's card,
shipper's certificate, or any other such papers accompanying a
shipment. This is necessary to enable the receiving establishment to
determine the number of hours the products have been in shipment.
Compliance with the requirement ends when the raw meat product
enters a ready-to-eat process at the establishment or is no longer in
the possession or under the control of the establishment. Product in
the possession of or under the control of the establishment remains the
responsibility of the establishment. Establishments must undertake all
reasonable precautions to ensure that such product is maintained as
required under the proposed rule, even when it is in a transport
vehicle or otherwise not physically at the establishment.
[[Page 6798]]
Although this proposal directly affects only FSIS-inspected
establishments, FSIS encourages adherence to the proposed time/
temperature requirements by all who handle or store raw meat and
poultry products. At the end of this preamble, the Agency discusses
plans to consider increasing oversight of the commercial handling of
meat and poultry at locations outside inspected establishments,
including during transportation, distribution and storage to the retail
level. FSIS will be considering measures to ensure proper handling and
cooking of raw and poultry products throughout the food safety
continuum.
B. Microbial Testing; Interim Pathogen Reduction Targets
As discussed earlier, the centerpiece of the FSIS food safety
strategy is to articulate what constitutes an acceptable level of food
safety performance by a meat or poultry establishment and hold the
establishment accountable for achieving that level of performance. In
the case of pathogenic microorganisms on raw product, this means
establishing targets, guidelines, or standards and requiring
establishments to conduct regular microbial testing to verify current
processes and practices are achieving those targets, guidelines, or
standards, or whether further measures are required.
FSIS is proposing interim targets for pathogen reduction and
microbial testing in slaughter establishments. This is an initial step
toward measurable reductions in the incidence of contamination of meat
and poultry products with pathogenic microorganisms. It also is a first
step toward the eventual incorporation of microbial testing as an
integral part of process control and verification in facilities
operating under the HACCP approach proposed later in this document.
Before describing the proposal for interim targets and microbial
testing, a brief description of the Agency's current use of microbial
testing is provided.
1. Current Testing Program
FSIS's current regulatory use of microbial testing is generally
directed at detecting product that is contaminated with bacteria of
particular public health concern.
FSIS has made and will continue to make, on a case-by-case basis,
determinations that a meat or poultry product presents an unacceptable
public health risk, and is adulterated, due to the presence of specific
pathogenic microorganisms in or on the product. Affected product may be
processed or raw. The discretionary authority to take immediate action
in such cases to protect public health is an essential part of the
Agency's food safety mandate.
Processed products that purport to be fully cooked and/or ready-to-
eat have been and will continue to be deemed adulterated if found to
contain pathogenic bacteria or toxic metabolites. These are products
that consumers are likely to eat without further cooking. Consumers
should be able to rely on processor's claims, implicit or explicit,
that the product is fully cooked and/or ready-to-eat. Such product
should in fact be ready to eat; further cooking should not be required
to protect the consumer from pathogens.
FSIS currently operates programs to test various products for
specified pathogens. Before establishing microbial testing programs,
and if there is evidence of a potential public health risk from a
pathogen being in or on a particular processed, ready-to-eat product,
FSIS performs a risk evaluation that focuses primarily on the
pathogenicity of the organism and the seriousness of the resulting
disease.
If it is determined that there is a public health threat due to the
risk of serious illness from consumption of a contaminated product, the
Agency undertakes three related actions. First, product tested and
found positive for the prohibited organism or toxin is retained and any
implicated product in commerce is recalled voluntarily by the producing
establishment. Second, the Agency undertakes a testing program to
detect other products similarly contaminated and acquires data to
decide if further actions are required. FSIS works with the
manufacturer and distributors to return all implicated products to the
inspected establishment. Appropriate public notices are given. Recalled
product is destroyed or, if appropriate, reprocessed to destroy the
contaminant, under FSIS oversight. Third, FSIS works with the
establishment to determine the cause(s) of the contamination and to
ensure that appropriate processing or other changes are made by the
establishment to prevent a recurrence.
FSIS has made numerous determinations in the past that particular
pathogens will, if found on a particular processed, fully cooked and/or
ready-to-eat product, cause that product to be considered adulterated
under the law, and has instituted testing programs accordingly. The
following ready-to-eat products are tested for the presence of the
microorganisms or their toxins, which, if found, will cause the product
to be deemed adulterated, as indicated:
--Cooked beef: Listeria monocytogenes, Salmonella
--Sliced ham: Listeria monocytogenes, Salmonella
--Cooked meat patties: E. coli O157:H7
--Dry and semi-dry fermented sausages: Staphylococcal enterotoxin
--Jerky: Listeria monocytogenes, Salmonella
--Large diameter cooked sausages (e.g., bologna, salami): Listeria
monocytogenes, Salmonella
--Small diameter cooked sausages (e.g., hot dogs, kielbasa, bratwurst):
Listeria monocytogenes, Salmonella
--Meat and poultry salads and spreads: Listeria monocytogenes,
Salmonella
--Cooked poultry products: Listeria monocytogenes, Salmonella
Most recently, FSIS determined that raw ground beef found to
contain Escherichia coli O157:H7 is considered adulterated. This
determination was made based on several factors. First, only small
numbers of the O157:H7 strain of E. coli are required to cause serious
illness or death, especially among children and the elderly. Second,
traditional and accepted cooking practices for raw ground beef (e.g., a
medium rare or slightly pink hamburger) do not kill E. coli O157:H7.
Third, the illness caused by the bacteria can be transmitted to others
(especially among highly susceptible small children). FSIS is
conducting limited sampling and testing of raw ground beef in
establishments and in the marketplace for the presence of E. coli
O157:H7.
The key characteristic of current FSIS microbial testing programs
is that sampling and testing is conducted by FSIS to detect violations
and dangerous product contamination and to stimulate preventive
measures by industry. Current programs do not involve microbial testing
by establishments as part of an effort to verify process control and
evaluate the adequacy of an establishment's efforts to control and
reduce pathogens. FSIS believes its current testing programs serve a
useful purpose but are not adequate by themselves to protect consumers.
Microbial testing by companies to verify process control and
demonstrate progress toward pathogen reduction is an integral part of
FSIS's food safety strategy.
2. Proposed Targets and Testing
One approach to regulating pathogenic microorganisms in meat and
poultry slaughter operations would be to determine, based on risk
assessments, the levels of specific pathogens on raw meat and poultry
products that do not pose a significant risk of illness and
[[Page 6799]] prohibit distribution of products exceeding such levels.
The acceptable level of pathogens would be effectively zero (<1 per 25
grams) in at least some cases. The establishment of such standards is
the approach generally taken for the regulation of chemical additives
in food. It provides a very direct means of controlling and avoiding
substances in food that present a public health concern.
FSIS has not taken this approach in the past with respect to
pathogenic microorganisms on raw meat and poultry. FSIS has been
constrained by the lack of a scientific basis for determining the
levels at which specific pathogens do or do not present a safety
hazard, particularly in regard to the potential for pathogens to
increase or decrease during distribution, marketing and consumption.
FSIS also has relied in part on the fact that proper cooking kills
pathogens present on raw product. The closest FSIS has come to this
approach is its recent decision to treat raw ground beef contaminated
with any amount of E. coli O157:H7 as adulterated within the meaning of
the FMIA, but this was based on the fact that traditional and accepted
cooking methods for raw ground beef (such as in a ``medium rare''
hamburger) do not kill this dangerous pathogen.
FSIS believes that determining the levels of specific pathogens
that pose a public health risk and using those levels for regulatory
purposes is a desirable goal because it provides a very direct means of
defining an acceptable level of food safety performance by a meat or
poultry establishment and for holding the establishment accountable for
achieving it. As a general matter, however, this approach currently is
not available to FSIS to deal with the broad array of pathogens in raw
meat and poultry. There are large gaps in the scientific knowledge
required to determine levels of specific pathogens that do and do not
pose a hazard. For example, with certain infectious pathogens where the
primary mode of transmission involves cross-contamination, it is
currently not possible to correlate pathogen levels with risk of
disease (e.g., Campylobacter jejuni in raw poultry).
FSIS intends to continue to work with the scientific and public
health communities and the meat and poultry industry toward determining
what levels of specific pathogens on specific products pose public
health concerns requiring regulatory action and to reduce pathogens
below those levels to the maximum extent possible. However, the
scientific and public health policy issues involved are complex and
their resolution will require a concerted, long-term effort. Some of
the issues and FSIS's plans for public meetings to begin addressing
them are described below in Part III.
For the present, FSIS has decided to pursue an alternative strategy
for pathogen reduction that is based on the same principle of
articulating an acceptable level of food safety performance and holding
establishments accountable for meeting it, but that also takes account
of what is achievable today. Specifically, FSIS is proposing interim
targets for reducing the incidence of contamination of meat and poultry
carcasses and ground meat and poultry products with Salmonella, coupled
with requirements for all affected establishments to conduct microbial
testing to determine whether their targets are being achieved. FSIS
believes that significant progress can be made in pathogen reduction by
taking advantage of current technologies and industry capabilities,
even as the Agency's HACCP program develops and the scientific basis
for setting more definitive targets, guidelines or standards evolves.
The proposed Salmonella testing program is an important element of
FSIS's food safety strategy because it will:
(1) reduce the prevalence of pathogens of public health concern;
(2) induce process changes by some establishments that are needed
to achieve both the target for Salmonella and a reduction in the
frequency and level of contamination of raw meat and poultry with other
pathogens;
(3) establish the principle that the FSIS's inspection program and
establishment process control programs must begin directly targeting
and reducing pathogenic microorganisms of public health concern;
(4) begin building the foundation for HACCP, which will rely on
microbial targets, guidelines, and standards to help define the process
controls that will be needed to achieve the desired level of food
safety performance; and
(5) begin building a database on the prevalence of Salmonella
contamination, which will be used for national trend analysis and as an
essential tool for setting future pathogen reduction goals.
The Agency's interim target and microbial testing proposal includes
the following major elements:
(1) selection of Salmonella as the target pathogen;
(2) identification of a national baseline occurrence of Salmonella
contamination for each major species and for ground meat and poultry;
(3) adoption of, as an interim target for pathogen reduction, the
requirement that within two years, or some other period specified by
FSIS through this rulemaking, each establishment achieve an incidence
of contamination below the current mean national baseline;
(4) a requirement that each establishment conduct daily testing for
Salmonella to determine whether the establishment's process controls
are, over a specified period of time, achieving the interim target; and
(5) prompt development and implementation of remedial plans by
establishments not meeting the target within a specified period.
The Agency invites public comment on its proposal to establish
interim targets for pathogen reduction and require microbial testing.
The proposal's major elements are outlined below following a brief
discussion of the public health rationale for targeting reduction in
incidence of a specific pathogen as a step toward reducing the risk of
foodborne illness associated with meat and poultry products.
3. Public Health Benefit of Interim Pathogen Reduction
As noted in earlier portions of this document, Salmonella,
Campylobacter, E. coli O157:H7, Listeria monocytogenes, Staphylococcus
aureus, and Clostridium perfringens constitute the major bacterial
pathogens associated with foodborne illness. Healthy People 2000
outlines goals for reducing the incidence of each of these pathogens.
Salmonella, Campylobacter, E. coli O157:H7, and Clostridium perfringens
appear to be introduced into meat and poultry primarily at the time of
slaughter. Public health concerns arise from this initial
contamination, in combination with other variables including subsequent
handling by industry and the consumer, opportunities for cross-
contamination, cooking practices, and the like. These variables have
been described in detail in the 1987 National Academy of Sciences
report, Poultry Inspection: The Basis for a Risk Assessment Approach.
While FSIS cannot quantify the reduction in disease incidence which
will occur with specific interim reductions in bacterial contamination
of raw product, simply reducing the percentage of product containing a
pathogen should result in a reduction in disease incidence, although
mishandling may still occur.
Each pathogen has a somewhat different epidemiology, and responds
to different interventions in different ways; for example, some
interventions may be very effective for Salmonella, but have
[[Page 6800]] a minimal effect on E. coli O157:H7. For these reasons,
it will be important for the long term that testing be pathogen-
specific: i.e., establishments should look for what is known to be
important in a particular product line, and target interventions and
monitoring to that particular pathogenic microorganism. As a part of
implementing HACCP, processors will need to determine what pathogens
are a major risk for their product, and design interventions and
monitoring accordingly.
Even under HACCP, it will not be practical or necessary to test all
products for all pathogens. Nonetheless, there are certain pathogens,
such as Salmonella, which are present on virtually all raw food
products. Salmonella is the leading cause of bacterial foodborne
illness in this country, and causes the greatest economic burden. As
such, it is likely that virtually any HACCP based testing program for
pathogens on raw product would identify Salmonella during the hazard
analysis as an organism of primary concern. Based on these
considerations, FSIS is proposing reduction in the incidence of product
contamination with Salmonella as an interim target for pathogen
reduction.
FSIS recognizes that reductions in incidence of Salmonella
contamination does not guarantee equal reduction in other pathogens.
Nonetheless, insofar as interventions designed to decrease the
incidence of contamination with Salmonella reduce overall levels of
fecal and ingesta contamination, which is the largest single avenue for
contamination of meat and poultry by pathogenic microorganisms, those
interventions should have a beneficial effect on other human pathogens
of animal intestinal origin. The Agency recognizes that there are other
foodborne human pathogens of public health concern that can be isolated
from raw meat and poultry product. The Agency would welcome comments on
the targeting of other pathogens in addition to or in lieu of
Salmonella.
The following sections discuss the major elements of the proposed
interim targets for pathogen reduction and requirements for microbial
testing.
4. Use of Salmonella as a Target Pathogen
FSIS proposes to require that each establishment that conducts
slaughter operations or produces raw, ground meat or poultry products
sample and test representative product daily for the presence of
Salmonella.
Due to logistical problems involved with attempting to test for all
possible pathogens, the Agency is proposing the use of Salmonella at
this stage as a target organism. Salmonella was selected for this
purpose because: (1) intervention strategies aimed at reducing
Salmonella can be expected to have comparable effects against most
other human enteric foodborne pathogens, (2) current methodologies are
available to recover Salmonella from a variety of products, (3) FSIS
baseline data suggest that Salmonella colonizes a variety of animals
and birds often enough for changes to be detected and monitored, and
(4) Salmonella is the most common cause of foodborne illness.
5. The Identification of National Baseline Levels as Reference Points
for Pathogen Reduction
FSIS proposes that all establishments that conduct slaughter
operations or produce raw ground meat or poultry products produce such
products such that the frequency of occurrence of Salmonella is at or
below the current national baseline average. These proposed baseline
levels tentatively identified by FSIS are provided in the chart below,
showing the frequency of occurrence in terms of the percent of tests
expected to be positive for Salmonella:
------------------------------------------------------------------------
Frequency
of
occurrence
Commodity of
Salmonella
(% +)
------------------------------------------------------------------------
Steers/Heifers.............................................. 1
Broilers.................................................... 25
Raw Ground Beef............................................. 4
Fresh Pork Sausages......................................... 12
Cows/Bulls.................................................. 1
Hogs........................................................ 18
Turkeys..................................................... 15
Ground Poultry.............................................. ..........
------------------------------------------------------------------------
To the extent possible, FSIS has used data from its Nationwide
Microbiological Baseline Data Collection Program as the basis for the
proposed baselines assigned to these raw commodities. This program
provides data on the prevalence of major pathogens and indicator
microorganisms associated with meat and poultry. The data generated
from these programs provide a comprehensive microbiological profile of
the raw commodities studied. The baseline studies on steers and heifers
and ground beef are completed. Studies on cows and bulls, market hogs,
and ground turkey and broilers are in progress, while studies are
planned for ground chicken and turkeys.
The pathogen reduction baselines for those commodities where FSIS
baseline studies have not been completed are estimates based on the
best data currently available to the Agency. FSIS recognizes that the
data available for some species are limited. The Agency believes,
however, that this rulemaking will generate additional data that will
help refine the baselines tentatively identified here.
The following is a summary of how the baselines were determined for
each of the raw products of concern.
The baseline established for Salmonella frequency of occurrence on
steer and heifer carcasses is based on the FSIS Nationwide
Microbiological Baseline Data Collection study conducted from 1992 to
1993. In this program, 2,089 samples were analyzed for Salmonella, as
well as other microorganisms, and 1 percent of the samples were found
to contain Salmonella.
Raw ground beef from federally-inspected establishments was tested
by FSIS. Out of 563 samples taken in this baseline study, 4 percent
were positive for Salmonella.
FSIS has also conducted several, more limited studies which help
provide an estimate of the frequency of occurrence of Salmonella in
regulated commodities, such as broilers, where baseline studies are
underway or planned. The data for Salmonella on broilers is from a FSIS
nationwide study conducted from 1990 to 1992. This survey found
Salmonella in 25 percent of the 1,874 birds sampled.
A 1979 FSIS study of retail-size, fresh pork sausages showed
Salmonella in 12 percent of the 603 samples tested. The 12 percent
frequency of occurrence for Salmonella as a baseline in fresh sausages
was derived from this study.
The 1 percent frequency of occurrence of Salmonella on cow and bull
carcasses is an estimate based on the completed baseline study on
steers and heifers. The baseline study for cows and bulls is in
progress.
As noted above, FSIS has not completed nationwide surveys for hogs,
turkeys, or ground poultry, but such studies are in progress or
scheduled for 1995. There have been no studies conducted for Salmonella
in ground poultry, so revelant data was not available to establish a
baseline. Few studies have been conducted for Salmonella on hog
carcasses. An industry group's recent review of the literature reported
several studies of Salmonella on pork carcasses conducted between 1961
and 1973. The studies reported wide ranges in the incidence of
Salmonella, from 49 percent to 56 percent, due in large part to the
variety of sampling procedures used. FSIS believes that in the absence
of more [[Page 6801]] recent and comprehensive U.S. data on hogs, the
best available data is that provided by a Canadian National Survey,
which FSIS believes to be adequate to establish a baseline for
Salmonella applicable to hogs in the U.S. In the Canadian survey,
salmonellae were isolated from 17.5 percent of the pork carcasses
sampled.
The Canadian study also reported a Salmonella frequency of 69.1
percent of the turkey carcasses sampled. However, several U.S. surveys
had conflicting results. A study conducted in 1979 showed 6.3 percent
of the 79 turkey carcasses sampled were positive for Salmonella.
Another U.S. survey compared Salmonella prevalence in three different
establishments. The turkey carcasses positive for Salmonella were 13
out of 40 samples (32.5 percent), 6 out of 39 samples (15.4 percent),
and 8 out of 40 samples (12.5 percent). Finally, an industry survey
conducted from 1987-1988 showed a 15 percent frequency of Salmonella on
turkey carcasses from the 25 plants that were sampled. The Agency
believes these U.S. industry surveys to be the most representative of
current conditions and is tentatively proposing to use the figure
obtained from the U.S. industry surveys as the proposed baseline for
Salmonella on turkey carcasses.
The Agency has no data upon which to establish baselines for the
other species of food animals subject to mandatory inspection. As such,
it is not proposing pathogen reduction target levels for minor
livestock species--sheep, lambs, goats, equines--or for minor poultry
species--ducks, geese, and guineas--at this time. The minor livestock
species together comprise 4-5 percent of all livestock slaughtered, and
the minor poultry species comprise only a fraction of 1 percent of
domestic birds slaughtered. Assuming that the public risk of foodborne
illness from these animals is comparably small, FSIS has decided to
focus this rulemaking on the major food species, and defer rulemaking
on these minor species. Comment is welcomed on whether FSIS should
include these species in its testing program and, if so, on what basis
it should do so.
FSIS recognizes that the data currently available to the Agency for
determining the current baseline and the appropriate interim target for
reduction in Salmonella incidence are limited. FSIS is also aware that
many meat and poultry companies have been conducting microbial testing,
in some cases for many years. The Agency believes that the industry
possesses a significant body of data that would help better define the
current baseline levels in various products prior to making final
decisions on these issues. FSIS strongly encourages the industry and
all those who possess relevant data to submit those data to the Agency
in response to this proposal and to assist the Agency in adopting
appropriate baselines as the reference points for pathogen reduction.
FSIS is also considering and invites comment on alternative
approaches to identifying baselines against which pathogen reduction
would be measured. One alternative would be to require the use of
pathogens other than Salmonella as the target organism for certain
products. For example, it could be argued that Campylobacter jejuni/
coli occurs at a greater frequency in poultry than Salmonella and as
such would be a more pertinent target pathogen. Likewise, according to
the available FSIS baseline survey data, beef carcasses have a
relatively low incidence of Salmonella contamination, suggesting the
possibility that other pathogenic microorganisms, such as Campylobacter
jejuni/coli, might be preferable target organisms for pathogen
reduction. FSIS would be prepared to adopt such alternatives if the
comments received on this proposal demonstrate that alternative
organisms would provide a more effective basis for achieving measurable
pathogen reduction in the near term.
Another alternative, discussed further below, would be to use the
current performance of a specific establishment as that establishment's
baseline for pathogen reduction in lieu of a national baseline.
FSIS also is interested in receiving data showing any correlation
between factors other than the species of slaughtered animals and the
incidence of pathogenic bacteria. For example, there are suggestions
that old animals (e.g., spent hens and culled cows) are more likely
than younger animals of the same species to harbor pathogenic bacteria
and should be addressed separately.
6. The Interim Targets
FSIS is proposing that each establishment, at a minimum, achieve
process control that will bring their incidence of Salmonella
contamination below the current national baseline incidence of
Salmonella found on that product within two years of the effective date
of this proposed rule.
The baseline levels were chosen as a basis for initial targets in
part because they are by definition averages that reflect a
distribution of levels among a broad range of establishments. Some
establishments have incidences of contamination above the national
baseline, while others are achieving rates of contamination below the
national baseline. FSIS believes that it is reasonable and feasible to
require, as an interim pathogen reduction measure, that all
establishments control their processes so that their Salmonella
incidence is no greater than the current national average.
FSIS is also considering a requirement that, for one or more
species, the target for pathogen reduction be some percentage reduction
in Salmonella below the national baseline, such as a 25 or 50 percent
reduction. This option is suggested by statements made by members of
industry that many establishments already are achieving a prevalence of
contamination well below FSIS's estimated national baseline incidence
of Salmonella contamination using currently available methods and
technologies. In the case of poultry, for example, some companies are
reportedly achieving a frequency of occurrence of Salmonella
contamination as low as 5 percent or less, well below the tentatively
identified baseline for broilers and turkeys. The principle underlying
FSIS's effort to establish appropriate interim targets for pathogen
reduction is that establishments should be moving to adopt process
controls and production practices that the industry itself has
demonstrated in actual practice are available and effective for
reducing the incidence of contamination with pathogenic microorganisms.
If reductions 25 or 50 percent below the national baseline are
reasonably achievable in the near term for a particular species, all
companies should work to achieve them. At the final rule stage, FSIS
will adopt specific percentage reductions below the national baseline
to the extent they are supported by the administrative record developed
in response to this proposal.
FSIS also invites comment on the appropriateness of the proposed
two year time period for reaching the interim target following adoption
of the final rule. Two years allows ample time for establishments to
determine their current performance through the microbial testing FSIS
is proposing and implement process controls and interventions that are
already available. FSIS may determine on the basis of comments that
different time periods, shorter or longer, may be appropriate for one
or more species, depending on what is feasible for that species and on
the degree of pathogen reduction FSIS adopts as the target. FSIS
invites comments on these issues. [[Page 6802]]
7. Requirement for Daily Testing
Each establishment would be expected to collect a minimum of one
specimen for testing each day from each slaughter class and/or class of
raw ground product, beginning 90 days following publication of the
final rule. Once-a-day sampling is based on the natural daily cycle in
production processes, starting with daily cleanup. Contamination builds
up as operations progress throughout the day. The required sanitation/
cleanup returns the level of contamination to essentially zero, thus
starting a new cycle. As explained in the next section, FSIS considers
one sample a day to be statistically adequate to verify process
control.
As alternatives to the one sample per day being proposed in this
document, FSIS considered requiring a sampling plan based on
establishment production volume, or by lot, which would have meant, for
most plants, many more than one sample per species per day. It also
considered a sampling plan based on less than one sample per species
per day, particularly for small plants. FSIS invites comment on its
sampling plan, including the frequency of sampling.
FSIS recognizes that some establishments are currently conducting
broader microbial testing than FSIS is proposing, and broader microbial
testing will play an important role in an establishment's
implementation of HACCP. More than once-a-day testing would have the
advantage of providing more rapid analytical verification of process
control. However, the Agency is proposing to require only one sample
per species per day to achieve the dual purposes of using a
statistically valid method and reducing the cost of testing. The Agency
believes that maintaining a requirement for species-based testing is
needed to provide analytical verification of process control.
As a general matter, single qualitative tests (positive or
negative) provide adequate but minimum acceptable information regarding
the level of process control. These singular results need to be
accumulated over time for process verification. Daily testing (one test
per day) was considered to be the minimum sampling required to deliver
acceptable sensitivity for detection of process deviations within a
realistic timeframe.
FSIS is not proposing at this time to use these testing results for
making decisions on the disposition of specific lots of product. The
amount of testing FSIS is proposing is not adequate to assure a
specific lot is free of Salmonella. The purpose of the testing is to
verify the performance of an establishment's system of process
controls. As explained below, establishments not meeting the target
within the specified time will be required to take remedial measures
under FSIS inspection.
As proposed, each establishment would develop a written protocol,
available for review by Program employees, outlining specimen
collection and handling. It would, at a minimum, include:
Designation of a responsible individual;
The number of specimens to be collected from each
slaughter class and/or species of ground meat and/or poultry;
Description of random sampling procedure (i.e., how to
determine which carcasses are to be sampled to ensure that specimens
are representative of that day's production);
Who will conduct the analysis (e.g., in-house laboratory,
commercial laboratory, etc.; and
Moving sum verification procedure (chart or table).
The designated representative of the establishment would collect
the specimen at the end of the production process. For meat this would
be prior to the carcass leaving the cooler; for poultry this would be
immediately post-chiller; for raw ground meat and poultry, this would
be prior to packaging. Samples would be taken as follows:
Poultry: whole bird rinse with the carcass selected after the
chiller, at the end of the drip line.
Beef: excised brisket skin tissue, 4 inches (10.2 cm) x 4 inches
(10.2 cm) x \1/2\ inch (1.3 cm) in depth, collected in the cooler,
after chilling.
Hogs: excised belly skin tissue, 3 inches (7.6 cm) x 5 inches (12.7
cm) x \1/2\ inch (1.3 cm) in depth, collected in the cooler, after
chilling.
Raw ground meat and poultry products: \1/2\-pound (0.4 kg) sample,
collected prior to packaging.
The analytical sample size and the method used would give a result
equivalent to the result that would be obtained using the FSIS
Procedure for Isolation and Identification of Salmonella from Food.
(Requests for this document should be sent to the Director,
Microbiological Division, FSIS, U.S. Department of Agriculture,
Washington, DC 20250.) Samples would be drawn randomly, from all
product produced. Samples would be taken for regulatory purposes and,
therefore, would be required to meet all of the attributes of an
official method (approved for use by Association of Official Analytical
Chemists or other recognized scientific body). The method chosen must
be verified by in-house data within the testing laboratory.
An establishment would be allowed to test the specimens in its own
laboratory or in a commercial/contract laboratory. However, the
laboratory that is selected must demonstrate experience in testing meat
and poultry for Salmonella spp. Either an internal or external
laboratory quality assurance/quality control (QA/QC) program with check
sample analysis would be required. QA/QC records must be available to
FSIS personnel, with FSIS reserving the right to send official samples
to the laboratory to verify laboratory capabilities.
The laboratory would record the results and provide the results
daily to the establishment, which would enter the results in a chart or
table daily to determine whether the process in question is meeting
pathogen reduction target levels.
The establishment would provide all the test results at least
weekly to Program employees for entry into the FSIS's database.
Electronic transmission of test results would be allowed.
8. Determining Compliance With Target Levels
In accordance with the FSIS food safety strategy of articulating
what constitutes an acceptable level of food safety performance by a
meat or poultry establishment and holding the establishment accountable
to that performance, a moving sum statistical procedure is being
proposed to evaluate whether establishments are achieving the interim
targets for pathogen reduction. The moving sum procedure is a tool for
evaluating whether the process control system is functioning and is
designed to assess the effectiveness of a system in relation to a
specified target level of performance. It focuses on a specific number
of days (window) within a production process and evaluates that process
to determine whether its performance meets or fails to meet that target
level over that period of time.
Using this moving sum procedure, establishments will track the
results of end-product testing to evaluate the effectiveness of their
production systems for controlling pathogens in relation to the interim
target FSIS will be establishing for each specific commodity. This
method of evaluation was chosen because it provides an effective means
of utilizing the microbiological assessment of end products to verify
process control, based on a single sample per slaughter class
[[Page 6803]] and/or class of raw, ground product per day.
FSIS believes the specific approach it is proposing for use of the
moving sum procedure will provide an effective means of ensuring that
establishments meet the interim targets for pathogen reduction. Any
establishment with positive Salmonella results at a frequency exceeding
that allowed for the product will be readily identified as failing to
meet the targets so that remedial measures can be implemented.
As proposed, the microbiological testing laboratory will supply the
test results on a daily basis to the establishment. Results would be
passed at least weekly to a Program employee for transmission to the
headquarters database. Alternatively, the establishment could transmit
the data directly to the headquarters database electronically, under
the supervision of a Program employee. In addition to being used to
verify establishment participation in the program, this information
will be used, in addition to baseline data, for national trend
analysis.
The establishment would be responsible for entering the results
into a moving sum verification table or chart (see sample of moving sum
table below). The moving sum is a procedure where results are summed
over a predetermined period of time. The moving sum consists of two
basic elements, a specified length of time over which results are
summed (n) and a maximum number of positives that are allowable within
that time frame (AL). These two parameters are based on the target
frequency of occurrence of Salmonella in that particular commodity and
the statistical decision criteria built into the procedure.
An advantage of a moving sum is once the criteria are set, all that
is required is a count of the positive results over the most recent
window of results.
For example, a chart where the number of days to be summed is 8
(n=8), and the maximum permitted number of positives during that time
frame is 3 (AL=3), showing whether the Acceptable Limit is met or
exceeded, might look like the following:
------------------------------------------------------------------------
Test Moving Days
Day No. result sum Comparison to AL included
------------------------------------------------------------------------
1................... 0 0 Meets............... 1.
2................... 0 0 Meets............... 1, 2.
3................... 0 0 Meets............... 1 to 3.
4................... 1 1 Meets............... 1 to 4.
5................... 0 1 Meets............... 1 to 5.
6................... 0 1 Meets............... 1 to 6.
7................... 1 2 Meets............... 1 to 7.
8................... 0 2 Meets............... 1 to 8.
9................... 0 2 Meets............... 2 to 9.
10.................. 0 2 Meets............... 3 to 10.
11.................. 0 2 Meets............... 4 to 11.
12.................. 0 1 Meets............... 5 to 12.
13.................. 0 1 Meets............... 6 to 13.
14.................. 0 1 Meets............... 7 to 14.
15.................. 0 0 Meets............... 8 to 15.
------------------------------------------------------------------------
The daily result is recorded as a 1 for a Salmonella positive test
and a 0 for a negative Salmonella test (e.g., the test for day 4 was
positive). The value of the moving sum for day 10, for example, is the
sum of the daily results for days 3 through 10. This value is merely
the number of positives in this window (two). It meets the Acceptable
Limit, AL=3.
Several features of moving sum procedures can be noted in the
example: (1) There is a startup period (days 1 to 7) in which there are
fewer than n=8 results in the sum; (2) a positive affects the moving
sum value for n=8 consecutive days; and (3) the moving sum gives equal
weight to all days in the window, from the most remote to most current.
FSIS is proposing to specify the moving sum rules for each product
class. The chart below specifies the initial time window values (n) and
Acceptable Limit (AL) for each product class:
------------------------------------------------------------------------
Moving sum rules
----------------------------------
Target
Commodity (percent Window
positive size (n) Acceptable
for in days limit (AL)
salmonella)
------------------------------------------------------------------------
Steers/Heifers....................... 1 82 1
Cows/Bulls........................... 1 82 1
Raw Ground Beef...................... 4 38 2
Fresh Pork Sausages.................. 12 19 3
Turkeys.............................. 15 15 3
Hogs................................. 18 17 4
Broilers............................. 25 16 5
------------------------------------------------------------------------
These moving sum rules are based on two assumptions: That the
production process is running in-control at the target level specified
for the commodity; and that specimens are randomly selected from the
end of the production process. They also reflect an effort by FSIS to
ensure that an establishment operating consistently within the target
will not exceed the Acceptable Limit for positive samples during the
window period (and thus trigger remedial action) while providing a high
likelihood that establishments regularly failing to meet the target
will be detected. [[Page 6804]]
It is important to recognize that this approach to verifying
process control in meat and poultry production is designed to assess
the effectiveness of a system over time in relation to a specified
target level of performance. It is not a means of evaluating and
approving individual product lots. The assumptions of an in-control
process and randomly selected specimens allow the performance
assessment to be separated from production volume considerations.
A number of alternative statistical criteria were considered as the
basis for the proposed moving sum procedures, ranging from an 80 to a
99 percent probability of meeting the limit if the process is operating
at the target level. The following table shows these alternatives with
their corresponding window sizes and Acceptable Limits for Salmonella
positives. For reasons discussed below, the 80 percent probability was
selected.
------------------------------------------------------------------------
Window
Probability of passing at target Target size (in Acceptable
days) limit
------------------------------------------------------------------------
80...................................... 1 82 1
4 38 2
12 19 3
15 15 3
18 17 4
25 16 5
90...................................... 1 53 1
4 28 2
12 15 3
15 12 3
18 14 4
25 15 5
95...................................... 1 36 1
4 21 2
12 12 3
15 10 3
18 12 4
25 11 5
99...................................... 1 15 1
4 12 2
12 8 3
15 7 3
18 8 4
25 9 5
------------------------------------------------------------------------
The alternative procedures differ in the probability they give for
not exceeding the moving sum limit when a production process is
operating at the commodity target. These probabilities range from 80 to
99 percent.
There are at least four considerations involved in selecting a
verification procedure: (1) Sampling and testing costs; (2) the nature
of the penalties for failing the verification procedure; (3) having a
low probability of exceeding verification limits when the producer is
meeting the target; and (4) having a high probability of exceeding
limits when the producer is not meeting the target. The procedures
based on a 99 percent probability of not exceeding the moving sum limit
at the target satisfy consideration (3), but do not satisfy
consideration (4). Establishment personnel would be very limited in
their ability to detect production processes not meeting the target.
There are two ways to improve the ability of the verification
procedure to detect when the production process is not meeting the
target. One is to increase the number of specimens required to be
tested each day, and the other is to lower the probability of passing
at the target. In view of the increase in costs to producers that a
higher sampling rate would entail and the fact that failing the test
does not condemn product (considerations (1) and (2)), FSIS selected
the procedures based on an 80 percent probability of passing at the
commodity target. The 80 percent probability was selected because it
enhanced the chance of detecting marginal performers and provides
establishments with an incentive to gear their process controls to
achieve frequencies of Salmonella contamination well below the proposed
interim targets. FSIS retains the discretion to not require remedial
measures by establishments that demonstrate they were meeting the
interim targets but exceeded the Acceptable Limits by chance.
To further evaluate the moving sum verification procedures, the
Agency simulated their performance at percent positive levels greater
than the interim target. As an example, the Agency looked at the
distribution of the number of days from startup to the first exceedance
of the AL for broilers (target of 25 percent) assuming a process
percent positive rate of 30 percent. The first exceedance occurred
within 22 days in 50 percent of the trials, and it occurred within 70
days in 95 percent of the trials. In other words, a process running at
30 percent positive rate (5 percent above the target of 25 percent) is
very likely to be detected within no more than 70 days.
Under the proposed moving sum rules, an establishment operating
just at the target would have approximately an 80 percent long-run
probability of satisfying (not exceeding) the moving sum limit. Over
the long term, the moving sum value will not exceed the AL about 80
percent of the days, assuming that the production process stays on
target. The proposed rules also mean that an establishment operating
just at the target has a 20 percent chance of exceeding the Acceptable
Limit and triggering remedial action. This is consistent with the
Agency's objective in establishing interim targets as a first step
toward holding establishments accountable for meeting acceptable levels
of food safety performance, because, due to the variability in pathogen
levels, establishments consistently operating at or just below the
target are likely to exceed the target from time to time.
The selection of 80 percent as the criterion for establishing the
proposed moving sum rules is intended to provide establishments with an
incentive to design their process controls in a manner that will
achieve pathogen reduction significantly below the designated interim
target. As in any random sampling scheme, there is a chance of actually
having positive results, even if the process is meeting the criteria.
However, an establishment can decrease its probability of exceeding the
AL (by chance alone) by targeting its process to produce product with a
lower frequency of positive samples. For instance, the establishment
could gear its process controls toward a 20 percent target as opposed
to the 25 percent target specified for broilers. This would benefit the
establishment by providing a greater assurance of not exceeding the AL,
since its own target is lower than the designated one.
A document giving a more detailed explanation of the moving sum
verification procedure will be made available by FSIS to those wishing
more information on this aspect of the proposal. Requests should be
sent to Assistant Deputy Administrator for Science, FSIS, U.S.
Department of Agriculture, Washington, DC 20250. FSIS welcomes comments
on alternative ways by which the Agency and establishments may
ascertain how well process controls are achieving national target
levels.
9. Establishment Action Required for Exceeding Target Limits
The establishment will have 90 days from the effective date of the
rule to establish microbiological testing regimes. Six months from
promulgation of the regulations establishments will be required to
track these interim target results using a moving sum verification
procedure and report the results to FSIS. Two years after promulgation
of the rules, establishments that are not achieving the interim targets
for pathogen reduction will be required to take corrective action under
FSIS supervision. In such instances, a review by the establishment of
its production practices and process controls is required. A written
report of the evaluation, including any identified process failures and
proposed corrective actions, would be submitted to the
[[Page 6805]] Inspector in Charge within 14 days from the day the
process exceeded the limits. This report would have to be updated on a
weekly basis until the process is back within the Acceptable Limit.
During the time the results exceed the moving sum limit, sampling
should be conducted at a higher rate of at least two specimens per day.
This will provide more accurate and timely data for effective
decisionmaking. This increased sampling has the advantage that,
assuming that the problem causing the initial deviation from the target
limit has been identified and corrected, the extra samples per day will
shorten the time frame (window) during which the establishment would be
considered operating above targets. The sampling rate would return to
normal when the moving sum value meets the AL. Additional testing may
be conducted by FSIS, at the Agency's discretion, as necessary to
assist firms in meeting pathogen reduction targets.
10. Relationship to HACCP
Once an operation has a history of consistent control and is
operating within the established limits, improvements in technology and
increased understanding of process control can be used to further
enhance pathogen reduction efforts. The continuous review of the
production process with corresponding improvements should set the stage
for implementation of state-of the-art process controls, namely HACCP.
FSIS is aware of and continues to encourage establishments to
implement effective HACCP programs as soon as possible. Establishments
that can demonstrate that their HACCP process controls produce only
products that meet or exceed the proposed targets for pathogen
reduction, and have an alternate verification program may, upon
approval by the Administrator, continue their current operating
procedure in lieu of the proposed verification program.
All establishments that have slaughter operations or produce raw,
ground beef or poultry are required to participate in this program
unless prior approval is granted by the Administrator, in a situation
where an establishment has instituted a HACCP system. That system
includes pathogen testing which, in the judgment of the Administrator,
meets or exceeds the testing requirements in the proposed regulations.
11. Alternative Approaches to Establishing Pathogen Reduction Baselines
and Targets
The principle underlying the proposed approach to pathogen
reduction outlined above is that production of raw meat and poultry
with an incidence of Salmonella at or below the national incidence
level is readily achievable with available technology and production
methods and that all establishments should be required in the relative
near term to perform at this level. This would establish a national
standard for food safety performance on which future pathogen reduction
efforts could be built. One potential disadvantage of this approach is
that it does not take account of the likelihood that current incidence
levels of Salmonella contamination vary widely. In the case of
broilers, for example, FSIS believes that some establishments are
already performing well below the 25 percent baseline incidence found
in the FSIS survey--at a 5 percent incidence level or lower--while many
establishments are performing well above that level. Some of the poorer
performing establishments may not be able to achieve reductions to the
targeted prevalence of contamination in the near-term. The better
performing companies--ones already performing well below the national
baseline--may feel economic pressure to relax their pathogen reduction
efforts to compete under a standard that is less strict than they are
already achieving.
An alternative approach would be to establish the initial baseline
for pathogen reduction on an establishment-specific basis and to
require significant interim reductions in each establishment from its
baseline. Such baselines would be established on the basis of either
reliable existing data from that establishment or on a brief required
period of sampling and testing in each establishment for the target
pathogen.
This approach would have some advantages. It would take account of
the likelihood that current performance in terms of incidence of
Salmonella contamination varies widely. Requiring, for example, a 50
percent reduction from the establishment-specific baseline would ensure
that some pathogen reduction is achieved by all establishments and a
larger reduction, in absolute terms, would be required by
establishments that currently have higher incidences of contamination.
This approach might achieve a greater overall reduction in incidence of
contamination, depending on the percent reduction required for each
establishment and the actual current distribution of incidence rates
across all establishments.
The establishment-specific baseline approach has disadvantages. It
would be more difficult to administer because it would require the
creation of approximately 2,500 establishment-specific baselines, and
it would not be based on the principle that there should be a
nationally recognized measure of food safety performance, regardless of
the establishment in which a product is produced. The establishment-
specific approach would also fail to recognize that some establishments
are already operating in accordance with the current state of the art
and may have difficulty achieving significant additional reduction in
the near term.
The latter concern might be addressed by hybrids of the two basic
alternatives outlined above. For example, establishments currently
above the national baseline could be required to reduce the incidence
of contamination to some level at or below the national baseline, while
the better performing establishments could be required to maintain
their current level of performance, perhaps within some appropriate
range.
FSIS invites public comment on these and other possible
alternatives to its proposed approach. At the final rule stage FSIS
intends to adopt an approach to setting interim targets for pathogen
reduction that takes into account its proposal, the alternatives
outlined here, and the comments received during the course of this
rulemaking.
C. Hazard Analysis and Critical Control Point (HACCP) Systems
1. Background
Overview of Rationale for Adopting HACCP
After having introduced key HACCP concepts and controls into
federally inspected establishments through the proposed near-term
interventions and microbial testing program discussed earlier in this
document, FSIS would secure its long-term strategy for improving the
safety of meat and poultry products by requiring that all such
establishments adopt HACCP systems. HACCP is a systematic approach to
the identification and control of hazards associated with food
production that is widely recognized by scientific authorities, such as
the NAS and the NACMCF and international organizations, such as the
Codex Alimentarius Commission, and the International Commission on
Microbiological Specifications for Foods (ICMSF), and used in the food
industry to produce product in compliance with health and safety
requirements. HACCP provides assurances and documentation that
processes used in manufacturing meat and poultry products are in
control [[Page 6806]] and producing safe, wholesome, unadulterated
products.
FSIS is proposing these regulations because a system of preventive
controls with documentation and verification of successful operation is
the most effective approach available for producing safe food. Emphasis
by the regulated industry on improving the control of microbiological
hazards in raw and cooked products in conjunction with process control
will reduce the risk of disease resulting from the presence of
pathogenic microorganisms in meat and poultry products.
HACCP is a conceptually simple system by which meat and poultry
establishments can identify and evaluate the hazards that could affect
the safety of their products, institute controls necessary to keep
these hazards from occurring, monitor the performance of these
controls, and maintain records of this monitoring as a matter of
routine. The HACCP systems mandated in these proposed regulations will
be limited to attributes affecting product safety, as opposed to
economic adulteration and quality parameters. If these regulations are
adopted, FSIS will verify HACCP system operations as part of its
program of continuous inspection.
FSIS is proposing to make HACCP mandatory for the meat and poultry
industry for the following reasons:
(1) Adoption of HACCP controls by the meat and poultry industry,
coupled with FSIS inspection activities designed to verify the
successful operation of the HACCP system, will produce a more effective
and more efficient system for ensuring the safety of meat and poultry
products than currently exists. HACCP appropriately places
responsibility on meat and poultry establishments to demonstrate an
understanding of hazards and risks associated with their products and
an ability to control the processes they use.
(2) A federally mandated HACCP system will provide the basis for a
modernized process control system capable of dealing with all the
hazards that might be associated with meat and poultry products
currently and in the future--biological, physical, and chemical.
(3) The expertise for applying HACCP to meat and poultry processes
and products is in an advanced state of development. Considerable
progress in applying HACCP to meat and poultry processes has already
been achieved by FSIS and other USDA agencies (e.g., the Extension
Service). Work has also been done by other Federal agencies, several
States, by academic institutions, by industry trade associations and
independent industry members.
(4) HACCP has a broad base of support. In March 1994, a variety of
constituent interest groups including consumers, the regulated
industry, scientists and other professionals, producers, employee
representatives, and other Federal and State governmental
representatives endorsed the HACCP approach as embodied in the seven
principles set forth by the NACMCF.
Meat and poultry industry representatives have urged the Federal
government to institute the mandatory use of a HACCP-based production
system for their products. In a recent letter, the American Meat
Institute (AMI) has petitioned the Agency to begin rulemaking to
mandate HACCP.
Members of the International Meat and Poultry HACCP Alliance
strongly support implementation of a mandatory HACCP program. The
Alliance consists of approximately 30 industry associations, 10
professional associations, 32 university affiliates, 6 service groups,
6 Government representatives and 5 foreign government representatives.
In its 1993 report, Creating a Government That Works Better and
Costs Less, Vice President Gore's National Performance Review
recommended that: ``[USDA] require all food processing establishments
to identify the danger points in their processes on which safety
inspections would focus * * * also [to] develop rigorous,
scientifically based systems for conducting inspections. * * *''
(5) A federally mandated HACCP system of preventive process
controls appears to be a prerequisite to continued access to world
markets. For example, the United States' largest trading partner,
Canada, has announced its intention to implement HACCP for meat and
poultry processes by 1996. Australia and New Zealand are also
implementing HACCP-based programs.
(6) Use of the limited public resources available to assure the
wholesomeness of the meat and poultry supply can be significantly more
effective if all meat and poultry establishments are controlling their
processes through HACCP systems. HACCP systems focus attention on
hazards to product safety and steps critical for their effective
control. HACCP systems generate data that can be used to continuously
assess whether the process is in control, and, when deviations occur,
what was done to correct the problem. These two characteristics of
HACCP systems will mean that inspector attention can be directed to the
safety related elements of the process and that inspector review can
utilize objective measures of how well the controls have been working.
(7) Implementation of mandatory HACCP systems in inspected
establishments permits separation and clarification of the differing
roles of establishment and inspection personnel. HACCP is an industry
process control system. Holding the industry responsible for the
development and effective operation of HACCP systems makes it clear
that production of wholesome meat and poultry products is industry's
responsibility, not the responsibility of the inspection service. The
role of the regulatory agency under HACCP is verification that the
establishment is controlling its processes and consistently producing
complying products.
Since all raw meat and poultry products contain microorganisms that
may include pathogens, raw food and the products made from it
unavoidably entail some risk of pathogen exposure and foodborne illness
to consumers. However, since pathogens are not visible to the naked
eye, consumers have no way to determine whether the food they buy is
safe to handle and eat. When foodborne illness does occur, consumers
often cannot relate the symptoms they experience to a specific food--or
any food--because symptoms may appear after some time has passed. Thus,
food safety attributes are often not apparent to consumers either
before purchase or immediately after consumption of the food. This
information deficit also applies to wholesalers and retailers who
generally use the same sensory tests--sight and smell--to determine
whether a food is safe to sell or serve.
The societal impact of this food safety information deficit is a
lack of accountability for foodborne illnesses caused by preventable
pathogenic microorganisms. When consumers cannot trace an illness to
any particular food or even be certain it was caused by food, food
retailers and restaurateurs are not held accountable by their customers
for selling pathogen-contaminated products and they, in turn, do not
hold their wholesale suppliers accountable.
This lack of marketplace accountability for foodborne illness means
that meat and poultry producers and processors may have little
incentive to incur costs for more than minimal pathogen and other
hazard controls. The Agency believes that today about as much process
control exists as current market incentives are likely to generate. The
existence of significant foodborne illness demonstrates the inadequacy
of the status quo. Thus, if foodborne illness is to be reduced, there
must be [[Page 6807]] an increase in systematic process control
throughout the industry. FSIS believes this need is best satisfied by a
mandated HACCP program.
The Agency invites comment on its rationale for mandating HACCP
rather than relying on market incentives to induce voluntary adoption
of HACCP. FSIS also invites comment on whether market incentives can be
increased or harnessed to improve food safety as a supplement or
alternative to the measures proposed in this rulemaking. FSIS invites
comment specifically on the role label claims about the safety or
safety-related processing of meat and poultry products might play in
encouraging and responding to market demand for safer food products.
The Principal Hazards Addressed by HACCP
Meat and poultry products may present physical, chemical or
biological (including microbiological) hazards to consumers.
Physical hazards may include extraneous materials of various kinds
that could be introduced into product during slaughtering and
processing operations. Usually, these extraneous materials (e.g.,
``buckshot''; barbed wire, glass or metal pieces) are easily prevented
from getting into the product at all and can be detected while the
product is still in the inspected establishment. Other physical hazards
result directly from slaughtering and processing operations (e.g., bone
chips and feathers). Random product examinations and finished product
standards are presently used to control these hazards.
Chemical hazards might result from residue contamination, improper
formulations, or use of compounds not intended for food purposes. The
results from the past several years of FSIS's residue-monitoring
program suggest that contamination of the meat and poultry supply with
violative levels of chemical residues is relatively rare; although FSIS
test results cannot be extrapolated conclusively to all chemicals in
all products, 0.29 percent of analyses detected violative residues in
1993. Chemical contamination from improper formulations and inadvertent
or incorrect use of non-food compounds is usually prevented by in-plant
control activities.
The issue of responsibility for primary control of hazards
presented by chemical residues was raised by GAO in its recent report,
``Food Safety: USDA's Role Under the National Residue Program Should be
Re-evaluated'' (RCED-94-158). GAO reported that while Federal resources
for residue control cannot keep pace with the industry's growth, the
industry has recognized that it must ensure, and document that its
products comply with applicable residue standards.
* * * the Congress may wish to consider[:]
--Requiring FSIS to establish scientific, risk-based HACCP systems
with the industry for residue prevention, detection and control;
--Having FSIS shift primary responsibility for day-to-day residue
prevention, detection and control to the industry; and
--Requiring FSIS to adopt a regulatory oversight role designed to
ensure the effectiveness of the industry's efforts.
FSIS accepts and agrees with the direction of these recommendations
and believes that mandatory HACCP for slaughter and processing
operations presents the opportunity to make this shift so that the
industry is more completely responsible for the safety of its products
with respect to the chemical hazards presented by residues, especially
animal drugs.
Biological hazards associated with disease conditions in animals
are presently addressed by specific FSIS disease inspection techniques.
Hazards include such disease conditions as anthrax, tuberculosis,
brucellosis, leukosis, cysticercosis, and other septicemic and toxemic
conditions. The detection and control of these hazards is accomplished
through ante- and postmortem inspection performed by FSIS employees on
livestock and poultry. When, upon examination, livestock and poultry
display signs or symptoms of disease, they are condemned or subject to
restrictions, such as ``passed for cooking only.'' Parasitic conditions
are also the subject of inspection procedures.
Several human pathogens of enteric origin do not normally produce
signs or symptoms of disease in animals or birds but will produce
foodborne illness in humans. These microorganisms are among the most
significant contributors to foodborne illness associated with
consumption of meat and poultry products, but present inspection
techniques are not effective in detecting and controlling the presence
of pathogens on raw products.
Processing procedures used to manufacture ready-to-eat products are
designed to destroy pathogenic microorganisms and, if properly
conducted, are effective. Microbiological testing is used to verify
these processing procedures. In 1993, there were 11 voluntary recalls
involving 1.7 million pounds of product for bacterial contamination in
ready-to-eat products. These recalls were principally the result of
detecting Listeria monocytogenes, which is frequently a post-processing
environmental contaminant, and not an indication of a failure of the
heat treatment procedure to produce a pathogen-free product.
As explained in earlier sections of this document, there is a
compelling public health need to establish systematic process controls
for raw meat and poultry products, to prevent their contamination by
pathogenic microorganisms and to reduce contamination when it
unavoidably occurs. These proposed rules will, for the first time,
mandate adoption of a system of control for all federally inspected
meat and poultry establishments, build on the foundation of the food
safety initiatives proposed earlier in this document, provide FSIS an
effective means to verify that establishments are meeting their food
safety responsibility with respect to pathogenic microorganisms, and
provide the basis for the science-based inspection system of the
future.
Overview of HACCP Principles
The HACCP approach to food safety was first developed by the
Pillsbury Company as a means of assuring the safety of foods produced
for the U.S. space program. The National Aeronautics and Space
Administration (NASA) wanted a ``zero defects'' program to guarantee
safety in the foods astronauts would be consuming in space. When NASA
and Pillsbury critically evaluated available systems for ensuring food
safety, they found that, even when very large numbers of finished
product samples were tested, a relatively large percentage of
potentially hazardous product could still be accepted. Pillsbury then
introduced and adopted HACCP as a system that could provide the
greatest assurance of safety while reducing the dependence on finished
product sampling and testing. HACCP, by virtue of identifying the
hazards inherent in the product and process, and devising preventive
measures that could be monitored, would control the process. Pillsbury
recognized that HACCP offered real-time control of the process as far
upstream as possible by utilizing operator controls and continuous
monitoring. Through this approach, Pillsbury dramatically reduced the
risk of microbiological, chemical, and physical hazards by anticipation
and prevention rather than inspection.
The presentation of the HACCP system by the Pillsbury Company at
the 1971 U.S. National Conference on Food Protection led to gradual
recognition of the value of the HACCP approach. This [[Page 6808]] was
reflected in the incorporation of the HACCP principles into FDA's
regulations for low-acid canned foods in 1973 to address serious
botulism problems in the canning industry. During the intervening
years, the concepts and rationale for utilizing the HACCP approach have
slowly gained acceptance throughout the food industry and scientific
community.
The USDA and the Department of Health and Human Services (HHS)
established the NACMCF in 1988 at the recommendation of the NAS to
advise the two departments on food safety issues. In 1992, the NACMCF
endorsed HACCP as an effective and rational means of assuring food
safety from harvest to consumption.
The Committee formulated seven principles to be employed in the
development of HACCP plans. These principles include hazard assessment,
critical control point identification, establishing critical limits,
monitoring procedures, corrective actions, recordkeeping, and
verification procedures. Under such a system, if a deviation occurs
indicating that control has been lost, appropriate steps are taken to
reestablish control in a timely manner to assure that potentially
hazardous product does not reach the consumer. A complete description
of the seven HACCP principles recommended by the NACMCF can be found in
the Committee's March 20, 1992, publication, ``Hazard Analysis and
Critical Control Point System.'' As outlined in a later section, FSIS
has adopted the seven HACCP principles as articulated by the NACMCF,
and is proposing that all HACCP plans include the principles. A
discussion of the seven HACCP principles and associated HACCP plan
elements follows:
Principle No. 1: Conduct a hazard analysis. Prepare a list of steps
in the process where significant hazards occur, and describe the
preventive measures.
The first step in establishing a HACCP system for a food production
process is the identification of the hazards associated with the
product. NACMCF defined a hazard as any biological, chemical, or
physical property that may cause a food to be unsafe for consumption.
For inclusion in the list, the hazard must be of such a nature that its
prevention, elimination, or reduction to acceptable levels is essential
to the production of a safe food. Hazards that involve low risk and
severity and that are not likely to occur need not be considered for
purposes of HACCP. Examples of several questions to be considered in a
hazard analysis include: (1) Does the food contain any sensitive
ingredients? (2) Does the food permit survival or multiplication of
pathogens or toxin formation during processing? (3) Does the process
include a controllable processing step that destroys pathogens? (4) Is
it likely that the food will contain pathogens and are they likely to
increase during the normal time and conditions under which the food is
stored prior to consumption? (5) What product safety devices are used
to enhance consumer safety (e.g., metal detectors, filters,
thermometers, etc.)? (6) Does the method of packaging affect the
multiplication of pathogenic microorganisms and/or the formation of
toxins? and (7) Is the product epidemiologically linked to a foodborne
disease?
Principle No. 2: Identify the CCP's in the process.
A critical control point (CCP) is defined as a point, step, or
procedure at which control can be applied and a food safety hazard can
be prevented, eliminated, or reduced to an acceptable level. All
significant hazards identified during the hazard analysis must be
addressed.
The information developed during the hazard analysis should enable
the establishment to identify which steps in their processes are CCP's.
To facilitate this process, the NACMCF developed a CCP decision tree
which can be applied to an identified hazard at each step of the
process (see Figure 3, below). The decision tree asks a series of
``yes'' or ``no'' questions to assist in determining whether a
particular step is a CCP.
BILLING CODE 3410-DM-P
[[Page 6809]]
[GRAPHIC][TIFF OMITTED]TP03FE95.002
BILLING CODE 3410-DM-C
[[Page 6810]]
Examples of CCP's may include, but are not limited to: cooking,
chilling, specific sanitation procedures, product formulation controls,
prevention of cross contamination, and certain aspects of employee and
environmental hygiene. All CCP's must be carefully developed and
documented.
Consistent with the principles of the NACMCF, FSIS is proposing to
require that establishments identify CCP's for food safety hazards in
their HACCP plans. All three types of hazards (physical, chemical and
biological, including microbiological) must be addressed and
controlled.
FSIS believes that implementation of mandatory HACCP, in
conjunction with related changes described elsewhere in this document,
will result in less risk of foodborne illness being associated with
these products. Therefore, identification of CCP's throughout the
production process for controlling microbial hazards is particularly
important.
Principle No. 3: Establish critical limits for preventive measures
associated with each identified CCP.
A critical limit is defined as a criterion that must be met for
each preventive measure associated with a CCP. Another way of
considering critical limits is that they serve as boundaries of safety
for each CCP.
Critical limits are most often based on process parameters, such as
temperature, time, physical dimensions, humidity, moisture level, water
activity, pH, titratable acidity, salt concentration, available
chlorine, viscosity, preservatives, or sensory information, such as
texture, aroma, or visual appearance in relation to the growth or
survival of target pathogens or chemical or physical hazards.
Establishment of critical limits should be justifiable in relation to
knowledge available from such sources as the meat and poultry
regulations or guidelines, literature, surveys, experimental studies,
or from recognized experts in the industry, academia, or trade
associations.
In accordance with the principles set forth by NACMCF, FSIS is
proposing that processors identify critical limits in their HACCP plans
that must be met at each CCP to be certain that the hazard is
controlled. Critical limits must reflect relevant FSIS regulations, FDA
tolerances, and action levels where appropriate. Processing
establishments are encouraged to establish critical limits more
stringent than those now in FSIS regulations or related documents to
ensure that regulatory requirements are routinely met even when
deviations occur. If critical limits more stringent than regulatory
limits or requirements are set, then the establishment must meet those
more stringent limits.
Principle No. 4: Establish CCP monitoring requirements. Establish
procedures for using the results of monitoring to adjust the process
and maintain control.
Monitoring is observations or measurements taken to assess whether
a CCP is under control. Monitoring is used to determine when a
deviation occurs at a CCP; therefore, monitoring procedures must be
effective. There are many ways to monitor CCP critical limits on a
continuous or batch basis; however, continuous monitoring is always
preferred. When continuous monitoring is not feasible, frequencies must
be sufficient to ensure that the CCP is under control. Statistically
designed data collection or sampling plans need to be developed in such
instances.
Assignment of the responsibility for monitoring is an important
consideration for each CCP. Personnel assigned the monitoring
activities must be properly trained to report all results, including
any unusual occurrences, so that adjustments can be made and any
processes or products that do not meet critical limits are identified
so that immediate corrective actions may be taken.
Monitoring activities are necessary to assure that the process is
in fact under control at each critical control point. Some monitoring
procedures could be accomplished by automatic instruments and devices
such as time/temperature recording devices. Some monitoring procedures
could consist of checks performed, with outcomes recorded. Other
monitoring procedures might involve rapid testing technologies that
provide feedback within appropriate time frames, for example, the use
of quick tests to verify levels of chlorine in poultry chillers.
HACCP requires establishments to systematically monitor, control,
and, where necessary, adjust their production processes to meet a
specified standard. Process monitoring may necessitate materials or
devices to measure, test, or otherwise evaluate the process at critical
control points. Examples would be such items as thermometers and test
kits.
FSIS is proposing to require that procedures for monitoring each
CCP be identified in the HACCP plan. These monitoring procedures should
assure that the monitoring systems are capable of detecting process
deviations, including product segregation and holding procedures,
effect of deviations on product safety, indicators for modification of
the HACCP plan, and the establishment employee responsible for
monitoring activities.
Principle No. 5: Establish corrective action to be taken when
monitoring indicates that there is a deviation from an established
critical limit.
A HACCP system is designed to identify potential health hazards and
to establish strategies to prevent their occurrence. However, ideal
circumstances will not always prevail in a processing operation and
deviations will occur. In such instances, the NACMCF points out that
corrective action plans must be in place to: (1) determine the
disposition of the non-compliant product and (2) identify and correct
the cause of the deviation to regain control of the CCP. Individuals
who have a thorough understanding of the process, product, and HACCP
plan should be identified and assigned responsibility for making
decisions. When appropriate, scientific experts must be consulted to
determine disposition of the product.
FSIS is proposing to require that establishments describe in their
HACCP plans the corrective actions that will be taken if a critical
limit is not met. Corrective actions must be specified in sufficient
detail to ensure that no public health hazard exists after these
actions have been taken. Although the process of developing a HACCP
plan emphasizes organized and preventive thinking about what is
occurring as the meat or poultry product is being manufactured, the
existence of a HACCP plan does not guarantee that problems will not
arise. For this reason, the identification of a planned set of
activities to address deviations is an important part of a HACCP plan.
Principle No. 6: Establish effective recordkeeping procedures that
document the HACCP system.
The NACMCF points out that an establishment's HACCP plan and all
associated records must be maintained on file at the establishment, and
provides several examples of records that could be maintained, such as
those relating to incoming ingredients, product safety, processing,
packaging, storage, and distribution, deviations and corrective
actions, and employee training.
A HACCP system will not work unless records are generated during
the operation of the plan, and those records are maintained and
available for review. One of the principal benefits of a HACCP process
control system to both industry and regulatory officials is the
availability of objective, relevant data. Thus, FSIS is proposing to
require that the HACCP plan provide for a recordkeeping system that
will [[Page 6811]] document the establishment's CCP monitoring,
verification activities, and deviation records. FSIS has also concluded
that recordkeeping systems are much more effective when they include
the actual values obtained, as opposed to terms such as
``satisfactory'' or ``unsatisfactory,'' which reflect a judgment about
the values and do not permit trend analysis.
Principle No. 7: Establish procedures to verify that the HACCP
system is working correctly.
The NACMCF defines verification as the use of methods, procedures,
or tests in addition to those used for monitoring, to determine if the
HACCP system is in compliance with the HACCP plan and/or whether the
HACCP plan needs modification and revalidation. Four processes are
identified as steps in the establishment's verification of its HACCP
system.
The first process is the scientific and technical process to verify
that all critical limits at CCP's are adequate and sufficient to
control hazards that are likely to occur in their specific process(es).
This is commonly referred to as ``validating'' the process.
The second process is to ensure that the HACCP plan functions
properly. Establishments should rely on frequent reviews of their HACCP
plan, verification that the HACCP plan is being correctly followed,
review of CCP records, and determinations that appropriate management
decisions and product dispositions are made when deviations occur.
The third process consists of documented periodic reviews to ensure
the accuracy of the HACCP plan. Such reviews should include an on-site
review and verification of all flow diagrams, CCPs, critical limits,
monitoring procedures, corrective actions, and records maintained.
The fourth and final verification process deals with the regulatory
agency's responsibility and actions to ensure that the establishment's
HACCP system is functioning satisfactorily. This verification can be
viewed as an overall process validation and can consist of any and all
of the verification activities mentioned above, plus final product
testing to demonstrate compliance with regulatory as well as other
desired performance standards.
FSIS is proposing to require that the HACCP plan include a set of
verification tasks to be performed by establishment personnel.
Verification tasks will also be performed by FSIS personnel. However,
an important benefit of HACCP is for establishments to take full
responsibility for producing a safe product. Thus, it is envisioned
that establishments, as well as the regulatory agency, will undertake
final product testing as one of several verification activities.
Verification tasks provide an opportunity to demonstrate that a well-
functioning HACCP system is in fact controlling a process so that safe
product is being produced under conditions that minimize preventable
risks.
The verification principle also links HACCP with the key element of
the FSIS regulatory strategy for pathogenic microorganisms, which is
the establishment of public health-oriented targets, guidelines, or
standards establishments must meet to engage in commerce. Without some
objective measure of what constitutes an acceptable level of food
safety performance with respect to pathogenic microorganisms, it would
be impossible to determine whether an establishment's HACCP plan is
acceptable and functioning effectively. FSIS is taking the first step
toward implementation of such objective measures with the proposed
interim targets for pathogen reduction, which focus on Salmonella. As
data become available, these targets will be refined, and possibly
expanded in slaughter operations and extended in processing operations,
to support the Agency's implementation of HACCP. Verification might
well include required microbial testing for all processes and species.
Eventually, such testing can be expected to be an integral part of
HACCP verification.
FSIS Experience With HACCP
(1) FSIS HACCP Study, 1990-1992.
In 1990, FSIS initiated a study of HACCP that focused on how this
system of process control could be applied within the meat and poultry
industries and what the implications might be for regulatory inspection
activities. This study was not designed to establish the efficacy or
benefit of the HACCP approach as a process control system. Recognition
of HACCP as a proven method for preventing and controlling food safety
hazards has been achieved through practical application of the concepts
to food production operations since 1971.
Recognizing that acceptance of HACCP within the meat and poultry
industries would be dependent on a broad range of constituent support,
the FSIS study involved consultations and public hearings; technical
workshops with representatives of industry, academia, and trade
associations to develop generic HACCP models; and testing and
evaluation of in-plant trials through case studies. In-plant testing
involved operational application of generic models for refrigerated
foods, cooked sausage, and poultry slaughter in nine volunteer
establishments.
The study underscored the significance of the change in roles and
responsibilities that use of a HACCP system brings both to the
regulated industry and to the inspection service. This finding would
later be supported by observations at a Round Table meeting on HACCP in
1994 that successful HACCP implementation will demand a culture change
within the inspection service and within the industry. Additionally,
the Agency's earlier experiences with HACCP-based regulations, such as
those for low-acid canned foods, cooked roast beef, and, more recently,
for cooked, uncured patties had demonstrated the advisability of
technical collaboration. The study experience confirmed these earlier
conclusions that technical collaboration was essential to successful
implementation of HACCP.
(2) HACCP Round Table, 1994.
FSIS was proceeding during 1993 to develop a HACCP regulation when
a group of concerned constituent organizations requested greater pre-
proposal involvement and public consultations prior to publication of
proposed regulations. USDA agreed to have a public event at which the
application of HACCP in the meat and poultry industry could be
discussed. This event became known as the HACCP Round Table.
On March 30 and March 31, 1994, FSIS held a two-day Round Table
meeting in Washington, D.C. Participants in the Round Table were
primarily selected by a procedure announced in the Federal Register on
January 13, 1994. Participants included public health officials,
representatives from the meat and poultry industry, consumer groups,
scientists and professional scientific organizations, producer and
farmer groups, USDA and other Federal, State, and local employees.
Prior to the Round Table, a steering committee of nine of the Round
Table participants determined the key issues to be addressed during the
forum. For each key issue, a particular question was developed to focus
the deliberations. Each issue, question, and deliberation is summarized
below. FSIS's views on those issues addressed by this regulation are
covered under ``Discussion of HACCP Proposal'' below. A report on the
HACCP Round Table has been published and is available from the FSIS
Docket Clerk at the address provided under ADDRESSES.
HACCP Plan Approval: What is the best way to ensure that HACCP
plans effectively incorporate the seven HACCP principles?
[[Page 6812]]
There was broad support for incorporating the seven HACCP
principles into HACCP plans. Different perspectives were expressed
concerning the means by which this might be achieved. These
perspectives ranged from having plans developed by certified experts,
to the use of objective baseline data from industry operations, and to
the use of generic models. Having and applying generic models and
guidelines to plant specific situations was considered desirable.
Training/Certification: What should be the role of FSIS with regard
to industry HACCP training?
This question generated discussion on three components: (1) HACCP
curricula, (2) training approaches, and (3) certification requirements.
The centrality of training to successful implementation of HACCP is
reflected in the broad range of perspectives offered. Curricula
concerns ranged from the need for uniform training on principles, to
the need for specific training on application of the principles within
a particular establishment operation, to the need for joint training
between inspectors and industry employees. Training approaches touched
on the need for training to be both available and affordable, and the
potential for training development and delivery to occur within various
private sector organizations as well as academia. Certification
requirements addressed the alternatives of having HACCP-trained
personnel in establishments, having HACCP consultants available on-
call, and having some type of certification process for such
individuals.
Phase-in: Should the mandatory HACCP requirement be phased-in and,
if so, how?
There was broad support for the notion of phasing-in HACCP
requirements, since allowing enough time for the HACCP program to
develop and grow is deemed critical for its success. Proceeding on a
deliberate schedule allows for an orderly transition within the
industry and permits adjustments of the regulatory infrastructure to
suit the HACCP structure within inspected establishments. A variety of
approaches to phase-in and timing were offered. A second point raised
was that the phase-in should take advantage of existing HACCP knowledge
and expertise, advancing first those industry segments whose process
control operations are more closely aligned with HACCP. A third point
offered was that the phase-in should provide for a transition or trial
period as application of HACCP occurs within a particular
establishment.
Measures of Effectiveness: How can it be determined initially, and
on a continuing basis, that HACCP plans are working effectively?
Participants discussed the need to develop measures of
effectiveness for HACCP plans. These ranged from the use of baseline
data on the process, establishment, and product level; to the use of
microbial, physical, and chemical guidelines; to the use of in-process,
as well as end-product testing; to the openness and accessibility of
data and records on selected measures of effectiveness. There was
considerable discussion concerning the need for finished product
testing to support verification of a HACCP program. The area of
greatest controversy was the need for microbial testing and the
development of microbial guidelines in conjunction with the need for
finished product testing. Different perspectives were offered on these
issues, on how such testing could be accomplished, and on the practical
limits of detection, sample collection, and testing.
Compliance/Enforcement: What are the best ways to adequately
enforce and ensure compliance with HACCP requirements?
Participants presented views on the types of regulatory authority
that would be appropriate in a mandatory HACCP system. Viewpoints
ranged from those who believed that current enforcement authorities are
adequate, to those who stated a need for new authorities (e.g., civil
penalties) and those who believed a review of enforcement authorities
should be undertaken to reflect the changes in roles and
responsibilities between the industry and the inspection service. There
was significant discussion concerning deviations from HACCP
requirements and how these deviations should be handled, including
appropriate enforcement responses to repeated deviations from the HACCP
plan. Here, two major points of view were articulated. The first view
was that any deviation from a HACCP plan could result in a regulatory
remedy (rather than criminal remedy) and that a deviation from a CCP,
while a food safety concern, should result in a regulatory response
related to the level of severity (in terms of risk to human health) of
the deviation. The second view was that any deviation from the HACCP
plan constitutes adulteration, hence a violation of law subject to
enforcement action. This view holds that, since HACCP is intended to
address potentially serious food safety hazards, a deviation is a
violation. A final point of discussion on this issue was employee
protection from reprisals for reporting food safety hazards (e.g.,
whistleblower protection for industry employees).
Relationship and Effect of HACCP on Current Inspection Procedures:
To what extent will the possible changes in the regulated industry
impact on possible changes in the current inspection system?
Discussion on this issue centered on five points: Modification of
inspection procedures to take advantage of HACCP plans; advantages and
disadvantages of continuing current regulatory programs until HACCP is
fully implemented; ways to combine HACCP and the current inspection
system; the extent to which changes in industry will affect changes in
inspection; and the potential effects of HACCP on small establishments.
Modification of inspection procedures to take advantage of HACCP plans
generally follow NACMCF recommendations that regulatory verification of
HACCP plans can be accomplished in lieu of, rather than adding to,
existing procedures. This would permit reallocation of inspection
resources to food safety concerns and away from quality attributes and
aesthetic concerns. HACCP should not invite an arbitrary reduction in
the inspection force and the numbers of inspectors should not be tied
to HACCP implementation. The potential effects of HACCP on small
establishments were noted, along with the view that some accommodation
during implementation should be afforded to these establishments.
All issues raised and discussed during the HACCP Round Table were
taken into account in formulating this proposal.
FSIS Experience With Process Control
(1) Current Application of Hazard Analysis to Meat and Poultry
Processing.
The principle of hazard analysis has been utilized to prevent
foodborne illness associated with specific meat and poultry products
and to support regulatory process control for certain voluntary
procedures. The examples discussed below represent FSIS's early efforts
using hazard analysis to identify CCP's in a production process and to
establish stringent regulatory requirements for controlling production
processes. Whereas the earlier regulations were prescriptive, the
current proposal is performance based, and holds the industry fully
responsible for conducting the hazard analysis and identifying the
CCP's and critical limits associated with producing products that
minimize the risk of foodborne illness. [[Page 6813]]
(a) Low-Acid Canned Foods
The low-acid canned food industry has had a remarkably good record
over the past 50 years, during which more than 1 trillion cans of
commercially canned foods were consumed. Beginning in 1970, however,
botulinum toxin and C. botulinum were found in commercially canned
product produced under the jurisdiction of both FDA and USDA. From 1970
until 1990, nine incidents of botulinum outbreaks occurred, resulting
in death on six occasions. The products implicated included mushrooms,
peppers, salmon, boned turkey, chicken vegetable soup, tuna, and bean
salad.
In response to the botulism outbreaks, the canning industry
identified CCPs that must be controlled and monitored to ensure that
canning operations produce safe canned foods. For products under its
jurisdiction, FDA in 1973 codified the CCPs into a good manufacturing
practice regulation for thermally processed low-acid canned foods
packed in hermetically sealed containers(21 CFR 110).
Since FDA's promulgation of that regulation (revised in 1978), the
threat of botulism in canned product has been greatly reduced. While
sporadic incidents continue, investigations of such incidents have
attributed the causes to establishments' failure to comply with the
regulation rather than inadequacies in the regulation.
To address problems in the canned meat and poultry industry, in
1986 FSIS promulgated HACCP-based low acid canned food regulations
similar to those of the FDA. CCPs identified in those regulations were
incorporated into the Agency's Performance Based Inspection System, so
that inspectors' tasks include verification of establishments'
compliance with the regulations. Incidents of foodborne illness
involving canned meat and poultry products that occurred following the
publication of the rules have been attributed to establishments'
noncompliance with the regulations.
(b) Commercially Processed Cooked Roast Beef
Five outbreaks of salmonellosis associated with the consumption of
commercially processed cooked beef products occurred in the
northeastern United States from 1975 until 1981. These outbreaks
resulting from five different serotypes of Salmonella, caused up to 200
reported cases of illness per incidence.
FSIS responded to the outbreaks by supervising the voluntary recall
and destruction of thousands of pounds of affected product on a case-
by-case basis. Additionally, whole, intact, cooked roast beef products
from several establishments were sampled and found positive for
salmonellae. As a result of the outbreaks, it became apparent that
salmonellae contamination of cooked beef products needed to be
addressed on an industry-wide basis.
In 1977, FSIS promulgated a regulation requiring that all cooked
beef products be prepared by ``a cooking procedure that produces a
minimum temperature of 145 degrees F in all parts of each roast'' to
destroy any salmonellae that might be present. This regulation was
amended in 1978 to provide alternate cooking times and temperatures to
preserve the rare appearance of the product but still destroy all
salmonellae. (See 9 CFR 381.17.)
During the summer of 1981, eight additional outbreaks of the
disease were linked to the consumption of roast beef produced by four
separate establishments in the northeastern United States.
Epidemiologic investigations revealed that inadequate cooking times
and temperatures were not the major problems. A new regulation was
implemented in 1983 that addressed the necessary handling, processing,
cooling times and temperatures, and storage requirements to ensure the
wholesomeness of cooked roast beef.
In total, the changes that evolved in the roast beef regulations
represented a HACCP approach in identifying the CCP's in roast beef
processing that must be monitored and controlled by an establishment to
ensure production of unadulterated product. These HACCP-based CCP's
have subsequently been incorporated into the FSIS-PBIS system for
scheduling inspectors' tasks in establishments that produce cooked
roast beef. Since 1983, no confirmed salmonellae outbreaks have been
traced to commercially prepared roast beef.
(c) Uncured Cooked Meat Patties
In response to recent outbreaks of foodborne illness caused by E.
coli 0157:H7, FSIS promulgated a rule dealing with the heat-processing,
cooking, cooling, handling, and storage requirements for uncured meat
patties. HACCP principles were used to identify CCP's, critical limits,
and corrective actions; as a result, cooking times and temperatures,
cooling requirements, sanitary handling and storage practices, and
requirements for the handling of heating or cooling deviations were
established. The CCP's identified in that rule have been incorporated
into the Agency's PBIS for scheduling inspector tasks to ensure
establishments' compliance with the regulations.
The ``Heat Processing Procedures, Cooking Instructions, Cooling,
Handling and Storage Requirements for Uncured Meat Patties'' (8/2/93 at
58 FR 41151) incorporated HACCP concepts (CCPs, critical limits,
corrective actions, etc.) associated with the manufacture of uncooked,
partially cooked, char-marked, comminuted products.
(d) Current Process Control Systems
The development and implementation of standardized process control
procedures, such as Total Quality Control (TQC) systems and Partial
Quality Control (PQC) programs have been part of an effort to focus the
responsibility for compliance on the processing establishment. FSIS
first began approving industry operated quality control programs in the
mid 1970's. The QC policy evolved throughout the late 1970's until in
1980 when it was codified in 9 CFR 318.4 and 381.145 providing a
regulatory basis for FSIS policies for PQC and TQC. At present, there
are over 9,000 approved PQC programs in operation in inspected
establishments and 361 approved and operating TQC systems.
TQC systems are defined by regulation as plans or systems for
controlling product after antemortem and postmortem inspection
throughout all stages of preparation adequate to result in product
being in compliance with the regulations (9 CFR 318.4(c) and
381.145(c)). This definition had traditionally been interpreted to mean
that an establishment's TQC system must include control for all aspects
of a process. By regulation, PQC programs may be approved for
controlling the production of individual products, individual
operations within the establishment, or parts of operations (9 CFR
318.4(d) and 381.145(d)).
In processing establishments, most approved PQC programs are
designed to control economic and quality aspects of meat and poultry
products, such as net weight and label claims. Such PQC programs are
generally voluntary or are a condition of label approval. A smaller
number of procedures operate to control product wholesomeness factors
and are mandated in current regulations. These include the production
of cooked roast beef (Sec. 318.17), mechanically deboned product
(Sec. 319.5), and irradiated poultry product (Sec. 381.145). In
addition, some PQC programs are approved as alternative procedures to
regulatory requirements such as handling thermal processing deviations
(Secs. 318/381.308) and finished product inspections (Secs. 318/
381.309) of shelf stable canned [[Page 6814]] meat and poultry
products. In slaughter establishments, PQC programs are designed to
control economic, quality, and some product wholesomeness aspects of
production. Such programs include finished product standards,
preoperational sanitation and carcass presentation. All slaughter PQC
programs are voluntary.
Preventive systems of process control have been formally employed
in the slaughter of broilers and Cornish game hens since 1983, and in
the slaughter of turkeys since 1984. These process control approaches
are integral features of inspection systems known as the New Line Speed
(NELS) inspection system for broilers and cornish game hens, and the
New Turkey Inspection System (NTIS) for turkeys (9 CFR 381.76). Forty-
five establishments operate under NELS today, and 27 establishments
operate under NTIS.
Under these slaughter process control systems, the establishment
demonstrates compliance with regulatory requirements by identifying the
points in the slaughter process that are important to regulatory
compliance. The establishment then sets realistic standards for these
points, and observes them often enough to detect deviation from a
standard before non-compliance occurs. The establishment also
identifies action it will take if a standard is not met. The written
program and the generated records of observations and actions are
evidence of the degree of process control and regulatory compliance. By
reviewing and evaluating establishment records and verifying them with
process observations as necessary, FSIS inspection personnel ensure an
establishment is meeting its responsibility to produce safe and
wholesome product.
The principal difference between slaughter process control systems
in place in NELS and NTIS establishments today, and the proposed HACCP
system is the focus of the systems. NELS and NTIS were designed not
only to address safety hazards associated with raw poultry carcasses,
but quality factors as well. The proposed HACCP system focuses on
hazards associated with safety of product.
International Efforts on HACCP
Between 1990 and 1992, a working group of the Codex Committee on
Food Hygiene developed a guideline document that covered the principles
and application of HACCP to all sectors of the food chain from producer
to consumer. The Codex Alimentarius Commission in 1993 adopted the
HACCP document that now serves as a benchmark for countries to
incorporate HACCP principles into their food industries. The seven
HACCP principles adopted by the Codex Alimentarius Commission are
identical to those proposed in this rule with the exception that HACCP
principles six (i.e., recordkeeping) and seven (i.e., verification) are
reversed.
In 1993, Agriculture Canada implemented a Food Safety Enhancement
Program, which is designed to encourage the adoption of HACCP
principles across all agri-food processed commodity groups and shell
eggs. The food industry will be required to control and monitor its
manufacturing process and maintain records at CCP's. FSEP will also
provide a means to help government inspectors prioritize their
responsibilities and focus their attention on CCP's in the process to
ensure the production of safe food. Full implementation of the FSEP
program is scheduled to be completed by September 1996.
Recently, the European Union (EU) adopted two Directives that made
reference to the HACCP system. One Directive (93/43/EEC) focuses on the
hygiene of foodstuffs and specifies that food business operations must
identify and control any step in their process critical for ensuring
food safety using the HACCP system. The other Directive (92/5/EEC) is
one specific to meat products, which also embraces HACCP principles.
These Directives were adopted on June 14, 1993 and February 10, 1992,
respectively. EU members have up to 30 months from the date of adoption
to implement the provisions of the Directives into national law.
Detailed guidelines are now under development for meat products.
New Zealand has also been proactive in adopting HACCP principles in
the food industry. Through the publication of Guide to the
Implementation of Hazard Analysis and Critical Control Point Systems in
the Meat Industry, the Ministry of Agriculture and Fisheries provided:
(1) a generic model from which an understanding of the HACCP approach
to food safety can be obtained; (2) a guide to the application of HACCP
systems, especially in the case of raw foods; and (3) specific examples
of application.
Adopting a HACCP system could potentially enhance international
trade opportunities for the United States. Although enhancing trade has
no direct effect on public health, participation in international trade
in food products is critical to the U.S. economy. The United States is
by far the world's major food exporter, with exports of raw
agricultural and processed food products of over $40 billion per year.
The United States also imports a substantial quantity of food products
each year from many countries around the world. HACCP will improve
FSIS's ability to monitor imports and thus ensure greater confidence in
their safety. Also, HACCP is becoming the world-wide standard to ensure
the safety of food and will thus serve as the basis for harmonizing
U.S. food safety regulations with those of other nations.
The Uruguay Round Negotiations under the General Agreement on
Tariffs and Trade (GATT) has resulted in further focus on this area.
The Agreement on the Application of Sanitary and Phytosanitary Measures
states the desire of member countries including the United States, to
further ``* * * the use of harmonized sanitary and phytosanitary
measures between members, on the basis of international standards,
guidelines, and recommendations developed by the relevant international
organizations, including the Codex Alimentarius Commission * * *''.
This trend toward harmonization coupled with the current
recommendations of the Codex Alimentarius Commission encouraging the
international use of HACCP, provide further support for FSIS's proposal
for a mandatory HACCP program for the production of all meat and
poultry products.
FSIS Guidance on Development of HACCP Plans
FSIS believes that it can facilitate development of HACCP plans in
various ways without compromising the principle that these are industry
process control plans and, as such, plan development is the
responsibility of the regulated establishment. Therefore, FSIS has
underway a series of planned assistance efforts, which will continue
and be completed over the next 6-12 months.
(a) Generic Models: FSIS has published the generic models developed
at Agency workshops and will publish generic models developed by NACMCF
as they become available. An example, the ``Generic HACCP for Raw
Beef,'' is provided in the Appendix.
FSIS has categorized in this proposed regulation all processes
carried out in the establishments it regulates. Because FSIS pilot-
testing has shown generic plans to be useful to establishments as they
develop plans specific to their own processes and products, FSIS will
publish and make widely available a generic model for each of the nine
process categories at least six months in advance of the due date for
each process category. FSIS believes that use of [[Page 6815]] generic
plans will assist in assuring the basic level of uniformity necessary
to have inspection activities based on establishment HACCP plans, and
that the provision of generic models will help to communicate the level
of detail expected in the elements of the plan. FSIS also believes that
generic models can help identify the kinds of hazards that should be
considered at various CCP's, without interfering with the
establishment's hazard analysis.
(b) NACMCF Materials: FSIS is publishing and will make widely
available guidance materials developed by NACMCF describing the optimum
steps to be followed in developing HACCP plans. In addition, FSIS is
currently exploring the most effective and economical approach to
developing a HACCP videotape.
(c) Computer Packages: FSIS is aware of commercially available
software programs that might assist food processors in developing HACCP
plans. FSIS has made a commitment to work with companies developing
these programs to make them more applicable to meat and poultry
processes.
2. Discussion of HACCP Proposal Regulatory Considerations
Process control is neither FSIS's responsibility nor a shared
responsibility between the Agency and industry. Each USDA inspected
establishment must assume full responsibility for making safe and
wholesome products. FSIS is responsible for assuring that products in
marketplace distribution are unadulterated, wholesome, and accurately
labeled. From a public health perspective, the more that industry
process controls anticipate and prevent problems, the less likely
products produced under such systems are to become adulterated.
HACCP is not an inspection system; it is an industry process
control system that provides opportunities to make inspection more
effective. Currently, FSIS performs inspection by having inspectors
generate information about the establishment's production process and
environment to evaluate the conditions under which meat and poultry
products are being produced. This activity permits oversight of
establishment efforts at the time of inspection. In contrast to this
relatively small amount of information, HACCP records will enable
inspectors to see how the establishment's processes have operated on a
continuing basis over time. The Program employee will be able to
determine whether problems have occurred and, if so, how they were
addressed.
In addition to providing a greater quantity of information and in
effect extending the scope of regulatory observations, the presence of
functional HACCP plans for all products and processes will also produce
more relevant data. This is because the monitoring and recordkeeping
requirements of a HACCP plan are organized around identified hazards,
CCP's, critical limits, and the actions taken to ensure that defects
are corrected before they become a risk. Finally, HACCP systems will
yield data that are more objective and more scientific.
(1) Definitions
For the purposes of this discussion and within this proposed rule,
FSIS has adopted some definitions of terms related to HACCP and HACCP
systems from the NACMCF in the publication titled ``Hazard Analysis and
Critical Control Point System,'' dated March 20, 1992; these
definitions are noted by ``*''. Other definitions are specific to FSIS
and its activities.
Corrective action. Procedures to be followed when a deviation
occurs.*
Criterion. A requirement on which a judgment or decision can be
based.*
Critical Control Point (CCP). A point, step, or procedure at which
control can be applied and a food safety hazard can be prevented,
eliminated, or reduced to acceptable levels.*
Critical Control Point (CCP) failure. Inadequate control at a CCP
resulting in an unacceptable risk of a hazard.
Critical limit. A criterion that must be met for each preventive
measure associated with a CCP.*
Deviation. Failure to meet a critical limit.*
HACCP. A hazard analysis and critical control point system (HACCP)
that identifies specific hazards and preventive measures for their
control to ensure the safety of food.
HACCP plan. The written document which is based upon the principles
of HACCP and which delineates the procedures to be followed to assure
the control of a specific process or procedure.*
HACCP-trained individual. A person who has successfully completed a
recognized HACCP course in the application of HACCP principles to meat
and poultry processing operations, and who is employed by the
establishment. A HACCP-trained individual must have sufficient
experience and training in the technical aspects of food processing and
the principles of HACCP to determine whether a specific HACCP plan is
appropriate to the process in question.
HACCP system. The result of the implementation of the HACCP plan.*
Hazard. A biological, chemical, or physical property that may cause
a food to be unsafe for consumption.*
Hazard Analysis. The identification of any biological, chemical, or
physical properties in raw materials and processing steps and an
assessment of their likely occurrence and seriousness to cause the food
to be unsafe for consumption.
Monitor. To conduct a planned sequence of observations or
measurements to assess whether a CCP is under control and to produce an
accurate record for future use in verification.*
Preventive measures. Physical, chemical, or other factors that can
be used to control an identified health hazard.*
Process. A procedure consisting of any number of separate,
distinct, and ordered operations that are directly under the control of
the establishment employed in the manufacture of a specific product, or
a group of two or more products wherein all CCP's are identical, except
that optional operations or CCP's, such as packaging, may be applied to
one or more of those products within the group.
Product. Any carcass, meat, meat byproduct, or meat food product,
poultry, or poultry food product capable of use as human food.
Recognized HACCP course. A HACCP course available to meat and
poultry industry employees, which satisfies the following: consists of
at least three days, one day devoted to understanding the seven
principles of HACCP, one day devoted to applying these concepts to this
and other regulatory requirements of FSIS, and one day devoted to
beginning development of a HACCP plan for a specified process.
Responsible Establishment Official. The management official located
on-site at the establishment who is responsible for the establishment's
compliance with this part.
Validation. An analysis of verification procedures, HACCP plan
components, and an evaluation of records associated with the HACCP
system to determine its efficacy for the production of wholesome
product for which the process was designed.
Verification. The use of methods, procedures, or tests in addition
to those used in monitoring to determine if the HACCP system is in
compliance with the HACCP plan and/or whether the HACCP plan needs
modification and revalidation.* [[Page 6816]]
(2) HACCP Plans
(a) Basis of Required Elements
The question of adherence to the seven principles of HACCP as
defined by the NACMCF has been considered by FSIS since it began HACCP
activities.
FSIS has determined that the scientific and conceptual integrity of
HACCP as articulated by NACMCF is critical to its success and to public
acceptance of inspection systems based on it. FSIS believes that each
principle is important to achieving the objectives of HACCP and that
the support of the scientific, technical, and industry communities for
HACCP rests on its overall integrity. Furthermore, the external advice
from such bodies as NAS and GAO recommending HACCP implementation
assumed adoption of all seven principles. Therefore, the Agency has
determined that its regulatory requirements will be founded on HACCP
principles as articulated by NACMCF. Comments are invited on this
fundamental premise of the FSIS proposed regulation.
(b) Required Elements
FSIS is proposing to require that inspected establishments develop
HACCP plans that include: identification of the processing steps that
present hazards; identification and description of the CCP for each
identified hazard; specification of the critical limit, which may not
be exceeded at the CCP and, if appropriate, a target limit; description
of the establishment monitoring procedure or device to be used;
description of the corrective action to be taken if the limit is
exceeded and the individual responsible for taking corrective action;
description of the records that will be generated and maintained
regarding this CCP; and description of the establishment verification
activities and the frequency at which they are to be conducted.
Critical limits currently a part of FSIS regulation or other
requirements must be met. FSIS invites comment on permitting approval
of alternative procedures if sound scientific reasons and data are
provided.
FSIS is proposing that the HACCP plan be signed by the responsible
establishment official as an indication of his or her accountability
for the plan. Comment is invited on the merits of such a requirement as
a method of ensuring and demonstrating establishment commitment to, and
formal adoption of, the plan.
(3) Overview of Plan Content and Format; Consistency With FDA
FSIS is aware that a large number of food producing companies are
regulated by both FDA and USDA. Earlier this year, FDA proposed to
mandate HACCP for seafood processors (59 FR 4142, January 28, 1994). In
formulating the proposal presented in this document, FSIS has tried to
assure conceptual uniformity and consistency with FDA on the practical
details to the greatest extent possible. However, differing statutes
are administered by the two agencies and each species--livestock, birds
and fish and shellfish--differ significantly.
In many important respects, the FSIS and FDA HACCP programs are
fully consistent. The same underlying principles of HACCP form the
foundation of the two programs. Both programs have the goal of
improving the microbial profile of regulated food products and,
thereby, reducing the incidence of foodborne illness that might be
associated with these foods.
Both programs require that establishments: develop HACCP plans that
address the health and safety aspects of their processes; have access
to at least one HACCP-trained individual; and recognize and carry out
their responsibility to control sanitation as a prerequisite to HACCP.
In addition, both regulatory programs are similar in that
operational success is the mechanism for acceptance of establishment
HACCP plans; verification tasks of all types will be conducted by
regulatory officials; and FSIS and FDA will attempt to provide
assistance to establishments through the development of guidance
materials or generic models from which industry efforts can begin.
FSIS is recommending that the format used in its generic models and
those of the NACMCF be followed by all establishments; however, Agency
personnel will be flexible in this matter and consider alternative
formats that ensure that both establishment and inspection personnel
can readily identify the hazards, the CCP's and the specific critical
limits, plus actions and records that should be associated with each.
The generic models are to provide guidance, not serve as blueprints,
and not substitute for process controls. FSIS proposes to publish and
make widely available both its generic models and the NACMCF models.
Comments are invited on this approach.
FSIS is proposing to require that each inspected establishment have
and implement a HACCP plan that is specific to each kind of meat or
poultry processing activity conducted in that establishment.
Establishments coming under inspection after the implementation date
appropriate for the process(es) to be conducted will be required to
develop their HACCP plans in conjunction with the application for the
grant of inspection. FSIS acknowledges that such establishments may
need some practical experience operating under their HACCP plan to
finalize their plans. FSIS invites comments on whether new
establishments coming under inspection should be granted a reasonable
amount of time, for example, six months, to finalize their HACCP plans
under commercial conditions.
(4) Sanitation as a Prerequisite to HACCP Plan Development
FSIS believes that there are certain prerequisites that must be met
before successful HACCP plan development can be accomplished. An
important foundation is the successful control of the cleanliness and
sanitation of the facilities and equipment, and adequacy of employee
sanitation and hygienic practices necessary in producing meat and
poultry products. FSIS is proposing that this be accomplished through
Standard Operating Procedures for sanitation. (See ``Near-term
Interventions'' section of ``DISCUSSION OF REGULATORY PROPOSALS,''
above).
These proposed regulations reflect the decision that HACCP plans
should address food safety factors only. FSIS invites comment on this
approach.
(5) Participation of HACCP-Trained Individuals
The Agency believes that establishments will vary widely in their
familiarity and experience with HACCP. All establishments will need to
have access to persons who have been trained in HACCP and its
application to meat and poultry production processes. Some
establishments have already chosen to secure HACCP training for their
staff or to secure consulting services. Others must accomplish this
before they begin the hazard analysis that will initiate their plan
development process. FSIS will consider an individual who has
successfully completed a recognized HACCP training course, as defined
in Secs. 326.1 and 381.601, to be a HACCP-trained individual.
A recognized HACCP course would consist of at least three days: one
day devoted to understanding the seven principles of HACCP; one day
devoted to meshing these concepts with this and other regulatory
requirements of FSIS; and one day devoted to development of
[[Page 6817]] a HACCP plan for a specified process. As discussed below,
the Agency expects that many organizations will be knowledgeable about
such courses and may serve as legitimate sources of such training. It
is the responsibility of the establishment sending its employee(s) to a
particular training course to ascertain that the course meets the
minimum requirements described above.
FSIS is aware that, through industry-sponsored training courses,
several hundred industry employees have already received the necessary
training. It is not expected that such training needs to be repeated.
Individuals who previously received HACCP training should be able to
supplement their knowledge through guidelines and informational
materials made available by FSIS, NACMCF, professional associations,
and trade associations. FSIS invites comments on this approach for
supplementing knowledge levels of previously trained individuals. In
cases where a consulting expert serves as the HACCP-trained individual
for an establishment, it is the responsibility of the establishment to
assure that this individual has the requisite training.
FSIS is also proposing that the HACCP-trained individual
participate in the hazard analysis and subsequent development of the
HACCP plans, and assist in addressing product safety in situations
where there have been deviations from critical limits and judgment is
needed to determine the adequacy of the response. HACCP-trained
individuals must also be available to establishments to participate in
plan modification and revalidation. FSIS does not believe it needs to
prescribe details about the hours or days on which the HACCP-trained
individual is to be on establishment premises, or what should be done
in establishments having multi-shift operations, other than to require
that the HACCP-trained individual be available to the establishment to
accomplish the prescribed role. FSIS is proposing that the
establishment have on file the name and a brief resume of the HACCP-
trained individual on whom it is relying.
The Agency has determined that a HACCP-trained individual must be
employed by each establishment. This individual will be responsible for
addressing and performing functions related to hazard analysis, plan
development, plan validation, review and assessment of critical limits,
and responses to deviations. The HACCP trained individual will be
pivotal in an establishment's ability to successfully assure process
control in an operational HACCP system. The Agency recognizes that
employment of a HACCP trained individual could also be accomplished
through acquisition of the services of a HACCP consultant. The Agency
does not intend to be overly prescriptive by specifying the conditions
of employment between the establishment and the HACCP trained
individual. It is, however, the determination of the Agency that the
services of a HACCP-trained individual able to carry out the activities
described above is essential to successful operation of a HACCP system.
Comments are invited on this approach.
This proposed requirement for involvement by a HACCP-trained
individual is an alternative to requiring that there be such an
individual in each establishment. FSIS recognizes that, for many
establishments, securing HACCP expertise by training one employee in a
recognized HACCP course is the best means to meet this requirement.
Comments are invited on this approach.
(6) Hazard Analysis
FSIS believes that success in HACCP plan development is founded on
a hazard analysis that is thorough and forces the establishment to
critically think about and analyze its processes. Guidance materials
prepared by the NACMCF for carrying out Principle 1 address this issue.
Especially for establishments without HACCP experience, this is a
critical and challenging first step. Because FSIS is concerned that
each establishment properly begin its application of the concepts of
HACCP, the Agency is proposing to specify a time frame prior to the due
date for any HACCP plan, during which hazard analysis should be
conducted.
The proposed time frame is six months; this means that six months
before any HACCP plan is required to be completed, establishments
should begin the hazard analysis process. Activities constituting the
hazard analysis include: accurately and completely describing product
composition, developing a flow diagram, listing of all hazards
associated with each processing step, and collecting of necessary
scientific data to assess and validate the effectiveness and
variability of process controls. During the six-month hazard analysis
period, there should be regular meetings between inspection personnel
and the establishment HACCP team on the subject of the hazard analysis.
Once the hazard analysis has been completed, it is expected that
identification of CCP's will begin and the activities related to the
remaining principles will be carried out so that the plan can be ready
and validated by the due date.
In only one circumstance will Program employees be expected to
report on the progress of these establishment activities with respect
to plan development; that is, if there has been no effort to initiate
hazard analysis, and the subsequent application of remaining HACCP
principles, at least one month prior to the due date for the HACCP
plan. FSIS believes that, in such a circumstance, there is a
considerable likelihood that the plan will be insufficient and that
regulatory action will be necessary. Therefore, Program employees will
report such a situation through their supervisory channels. FSIS
invites comment on this particular feature of the proposed
implementation schedule.
(7) Establishment-Specific HACCP Plan Acceptance
The question of HACCP plan acceptance has been long and thoroughly
considered by the Agency. In reviewing various options, the Agency has
maintained several objectives:
Any acceptance system should not include a requirement
that HACCP plans be physically forwarded to the Agency and remain in
its possession at one or a few central locations.
The acceptance system must accommodate varying
establishment-specific HACCP plans for similar products, but maintain
uniformity on basic standards.
The acceptance system should involve Agency in-plant
Program employees to the maximum extent possible, after they have been
provided the requisite education and training in HACCP.
The Agency gave serious consideration to requiring formal plan
acceptance prior to full plan operation, either by formal FSIS approval
or by an ``expert'' computer system. However, advice from colleagues at
FDA suggested that any system of acceptance prior to operational
validation was likely to be administratively complex and irrelevant to
successful implementation. Therefore, the Agency has decided that plan
acceptance will not be a one-time administrative event but a process.
Successful process control, as evidenced by the existence of a plan
having all the features required by the seven principles plus the
capacity of the plan to result in production of complying products,
will mean that the plan is acceptable.
Inspection activities will be designed to verify that the plan has
all the required features, that the plan and the [[Page 6818]] records
it generates are a reflection of what has occurred during processing of
products, that deviations have elicited appropriate responses, and that
continually complying products have been produced. Whenever any of
these conditions are not met, the plan will be judged to need revision
and revalidation.
In essence, establishment-specific HACCP plans will be developed,
reviewed, and validated at the establishment level on a continuing
basis, with activities by both establishment and Program employees.
This has emerged as the most viable and efficient approach for both the
Agency and industry.
Responding to Deviations From Critical Limits
FSIS is proposing to require that deviations from critical limits
trigger a prescribed set of actions by an establishment.
First, under this proposed provision, product affected by the
deviation from the critical limit must be segregated and held until the
significance of the deviation can be determined. Second, the
establishment must make the necessary determination of the effect of
the deviation on product safety. This determination must be made in
consultation with a HACCP-trained individual and any other subject-
matter experts needed to deal with the deviation in question. In
consultation with this person or team, the establishment should also
determine whether the deviation reveals the need to modify either the
process itself or the HACCP plan.
Finally, FSIS is proposing to require that establishments record
all steps taken in response to a deviation from a critical limit and
include that information as part of the HACCP record. Documentation of
deviations should be brought to the attention of FSIS personnel.
HACCP Recordkeeping
Maintenance of accurate HACCP records is fundamental to a HACCP
system and is the cornerstone of its usefulness to regulators.
Therefore, FSIS is proposing to require that these records contain
certain necessary information; that the records be systematically
reviewed by the establishment; that the records be maintained for a
specific period of time; and that FSIS Program personnel be given
access to these records.
First, FSIS is proposing that the records involving measurements
during slaughter and processing, corrective actions, verification check
results, and related activities contain the identity of the product,
the product code or slaughter production lot, and the date the record
was made. The purpose of this proposed requirement is to assure that
both the establishment and the regulator can readily link a record to a
product and the period during which the product was processed. FSIS is
also proposing to require that the information be recorded at the time
that it is observed and that the record be signed by the operator or
observer.
Second, FSIS is proposing to require that the HACCP records
associated with the product to be shipped be reviewed by an
establishment employee other than the one who produced the record,
before the product is distributed in commerce. The purpose of this
review is to verify that the HACCP system has been in operation during
the production of the product, that it has functioned as designed, and
that the establishment is taking full responsibility for the product
meeting applicable food safety regulatory requirements. If a HACCP-
trained individual is on-site, that person should be this second
reviewer. The reviewer should sign the records. FSIS program personnel
will be performing similar reviews of HACCP records on a regular basis,
but their oversight cannot be substituted for the establishment's
review.
Third, FSIS is proposing that HACCP records generated by the
establishment be retained on site for at least one year and for an
additional two years on-site or at another location. HACCP records will
be necessary in the revalidation process. Further, FSIS' experience
with other recordkeeping requirements indicates this is a manageable
time frame. FSIS invites comments on the appropriateness of these
records retention requirements.
Finally, FSIS is proposing to require that HACCP plans and records
be available for review and copying by program personnel at reasonable
times. Industry records are reviewed by Program personnel as part of
their assigned tasks. Comprehensive records access is necessary to
permit verification of all aspects of a HACCP system. However, FSIS
does not intend to routinely copy or take possession of such records.
It is the Agency's intent to generate its own records of its
verification tasks and results rather than duplicate the records of the
establishment. Data collection instruments for program employee
verification tasks are being developed and will become the Agency's
verification record that the HACCP system is functioning as intended.
Extensive copying of records is anticipated only in cases where
there was evidence of non-compliance with requirements or deviations
from critical limits that resulted in product safety problems. In such
instances, complete access to all pertinent records would be necessary.
FSIS invites comments on this issue.
Training
There is significant interest by the Agency in HACCP training for
Agency and industry personnel. FSIS takes full responsibility for the
training of its own personnel within time frames that permit the
orderly implementation of HACCP. The Agency's interest in HACCP
training for the regulated industry is based on the need to assure that
both industry and Agency personnel are receiving training that is
founded on a single vision of HACCP and how it is to operate.
Two areas concerning training requirements were considered by the
Agency in determining how training for HACCP-trained individuals should
be evaluated: The availability of training and whether to require
acceptance or accreditation for training programs.
Upon review the Agency determined that there are a number of
options for the industry when selecting the appropriate training course
for their employee(s). Among these are courses offered by industry
trade associations, such as AMI, the National Food Processors'
Association, and others. Academia also offers courses in HACCP
principles and application. Groups such as the HACCP Alliance, The
National Center for Food Safety and Technology, and accredited
universities are among the available sources for HACCP training.
Private consultants and consulting firms also offer HACCP training.
Other available resources include a list of HACCP courses prepared by
USDA's Extension Service. These training sources are all available to
the regulated industry although the cost, length, and to some extent,
the content of these courses differ. Recognizing that there are
differing needs for technical knowledge and ability to pay for these
courses among the regulated industry, FSIS has determined that each
responsible establishment official should be responsible for deciding
which provider of training best meets the establishment's needs.
A second concern is whether the Agency should stipulate that the
courses taken by a HACCP-trained individual be subject to acceptance or
accreditation. This accreditation could be conducted by the Agency, by
an outside body (e.g., [[Page 6819]] scientific body or professional
association) under the auspices of an industry-sponsored accreditation
system, or a decision to require no accreditation for courses could be
adopted. An outside source for accreditation could be created by the
industry as is the case in thermal processing where a nationally
recognized course is offered by industry. A scientific body or a
professional association could serve such a function.
FSIS considered the implications of serving as an accrediting body
for HACCP training courses. This option afforded three choices. First,
the Agency could provide accreditation review of all available HACCP
courses. This could be accomplished by contracting out the function.
Second, the Agency could provide this service to the regulated industry
through staff resources. This would require a significant diversion of
Agency resources from regulatory activities to servicing the industry
by approving a large volume of requests for review of HACCP courses.
Third, FSIS could publish a periodic list of unacceptable HACCP courses
based on the training received by HACCP-trained individuals in
establishments with proven histories of poor performance. This would
serve only to identify those courses the Agency determined through
establishment performance to be inadequate preparation for a HACCP-
trained individual.
To assure that training is timely, to reduce cost requirements for
the Agency and industry, and to assure that a wide range of options is
available to the industry, the Agency has tentatively concluded that
the adequacy of courses for a HACCP-trained individual should be
evaluated by each responsible establishment official. FSIS is not
proposing to establish an accreditation process to evaluate training
courses, because the Agency believes that its evaluation of the
establishment's HACCP performance is the most resource-efficient means
to reveal any training deficiencies or mistakes in the course
selections made by the establishment. The Agency is soliciting comment
on this approach and will consider other viable options for ensuring
appropriate training of industry personnel.
Implementation Schedule
Since mandatory HACCP was first considered by FSIS, the Agency has
been considering the significant issues surrounding orderly
implementation. Public discussions regarding phase-in have alternated
between the need for caution in implementing so significant a change
too quickly and a sense of urgency because of the food safety benefits
associated with HACCP. The time frame for implementation in these
proposed regulations attempts to balance these competing concerns. The
first phase-in of a process begins 12 months from the publication of
the final rule and ends at 36 months. This balanced phase-in approach
will permit the regulated industry time to accomplish the training of
personnel and adjust their activities to include necessary HACCP
activities.
FSIS proposes to establish a timetable for phasing in HACCP based
on industry production process categories. In identifying process
categories for phase-in of mandatory HACCP, the Agency has taken a
number of factors into account. These include the knowledge of areas
where controls similar to HACCP presently exist; consideration of all
activities conducted by regulated establishments; consideration of the
wide variety of products produced by the regulated industry that are
difficult to sort into separate product categories; and the nature of
changing and constant product development activities conducted by the
industry. Also in keeping with the process control principles inherent
in HACCP, FSIS has selected process as the basis for phase-in, rather
than product category. The Agency has identified process categories
that appear to encompass all the processes of the regulated industry.
They are:
01 Raw, Ground: This category includes ground red meat (beef,
pork, sheep, etc.), ground poultry, all mechanically separated species,
and mechanically deboned poultry.
02 Raw, Other: This category includes all red meat species and
poultry classes not fully cooked including non-intact muscle products
(shaped, formed, separated, etc.), all intact raw muscle products
including processed (injected, coated, breaded, tenderized, etc.) and
all cut, or boned product both bone-in and boneless.
03 Thermally Processed/Commercially Sterile: Included in this
category are retortable pouches and canned meat and poultry products.
04 All Other Shelf Stable, Not Heat Treated: This category
includes all products that are shelf stable including dried, controlled
by water activity, pH, dehydrated, freeze dried, fermented, and
products that meet the requirement for a maximum pH of 4.6, for example
freeze dried soup or meals, shelf stable salami, jerky, or dried beef.
05 Fully Cooked, Not Shelf Stable: This includes all keep
refrigerated or frozen products including those that are sliced and
packaged, and products prepared by central kitchens, for example cooked
sausage, hams, frozen fully cooked beef patties, pizzas.
06 All Other Shelf Stable, Heat Treated Product: This includes
rendered products, for example lard and oils.
07 All Non-Shelf Stable, Heat Treated, Not Fully Cooked Product:
This category includes ready-to-cook poultry, cold smoked and products
smoked as a trichinae treatment, partially cooked, battered, breaded,
char-marked, batter set, and low temperature rendered products, for
example partially cooked patties and nuggets, partially defatted beef,
ready-to-cook barbecued chicken, mettwurst, etc.
08 Non-Shelf Stable, with Secondary Inhibitors: This includes
products that are irradiated, fermented, salted, and brine treated, for
example, oriental sausages, pressed duck, and irradiated poultry.
09 Slaughter: This includes all red meat species, all poultry
classes, and all voluntarily inspected species and classes.
Special considerations for phasing HACCP into small establishments
are discussed below.
The proposed effective dates for each category are expressed in
relation to publication of a final HACCP regulation; the six month
Hazard Analysis period is to precede the effective date for each
process category.
In determining the phase-in sequence for these categories, four
options were considered.
The first proposed phase-in option considered is based on the
public health and safety risk inherent in the production process. Risk
considerations dictate that raw ground product be in the initial
implementation period, followed by slaughter since these processes
result in products that have been shown to pose the greatest risk for
foodborne illness. The process categories were then ranked according to
the food safety process controls applied during the manufacturing
process. This option would have phased-in Shelf Stable, Heat Treated
and Thermally Processed/Commercially Sterile processes in the final
groups. Those processes include areas in which significant
interventions take place during production to assure product safety.
The second option considered the controls that currently exist in
regulation mandating critical control points and critical limits
related to health and safety. This method would have phased-in those
processes where the greatest process control experience and regulatory
standards exist for the earliest implementation dates. The
[[Page 6820]] burden for the development of a HACCP plan and hazard
analysis would not have been as great for these establishments due to
past experience. This option would initially have phased-in processes
such as Thermally Processed/Commercially Sterile and end with Raw,
Ground; Raw, Other, and Slaughter processes. Phase-in would occur in an
inverse order from the first option considered.
The third phase-in scenario considered by the Agency utilized an
evaluation of the number of establishments producing products covered
by a process and the known volumes of industry production for each of
these processes. In this option, process category Raw, Other would have
been implemented first since this comprises a large sector of industry
production both by volume and the number of producing establishments.
The second process for phase-in would have been slaughter, since again,
this comprises a large portion of the regulated industry both in the
number of establishments and the volume of product produced. Thermally
Processed/Commercially Sterile would have been the final process
phased-in under this option since this process constitutes a small
segment of the regulated industry both in the number of producing
establishments and the volume of production.
The fourth option for phase-in, and the one proposed by the Agency,
incorporates considerations from each of the above-discussed options,
beginning with the processes that constitute the greatest public health
risks, combining some other processes where the volume of production in
the regulated industry is lower, using the option for processes where a
large body of experience and regulatory criteria presently exist, and
combining these for the existing time frame of total implementation
over a 1-to-3-year period from the publication of a final HACCP
regulation. In all options considered, the category encompassing small
establishments will be phased-in last. FSIS selected the fourth option
because it takes into consideration production, experience with process
control, and public health risk. FSIS invites comments on the proposed
phase-in schedule.
The Agency envisions that, upon the required implementation date
for phase-in, establishments will be completely ready to operate their
HACCP system and that FSIS will conduct inspection activities according
to HACCP principles, including verification and validation, to ensure
that the HACCP system as operating is acceptable.
The proposed phase-in schedule 4 is as follows:
Final rule plus 12 months: Raw Ground; Thermally Processed/
Commercially Sterile; and all Other Shelf Stable, Heat Treated
Products.
Final rule plus 18 months: All Non Shelf Stable, Heat Treated, Not
Fully Cooked; all Other Shelf Stable, Non Heat Treated.
Final rule plus 24 months: Fully Cooked, Non Shelf Stable; all Non
Shelf Stable with Secondary Inhibitors.
Final rule plus 30 months: All Slaughter; all Raw Other Product.
Final rule plus 36 months: Small Establishments.
Special Consideration for Small Establishments
FSIS believes that planned technical assistance activities offer
benefits to small establishments. Among these are the provision of
generic models from which to begin HACCP plan development and the
provision of other guidance material. Additionally, FSIS is proposing
that small establishments, regardless of the processes performed and
products produced, be permitted 36 months from the date of publication
of the final rule in the Federal Register to complete plan development.
In determining which establishments should be eligible for this
implementation schedule, FSIS considered three ways of defining
``small.'' The object was to distribute the economic burden equitably
among various segments of the industry.
(1) Defining ``small'' on the basis of units produced (number of
head slaughtered, number of birds slaughtered, or pounds of product
produced). Because of the difficulty of making meaningful economic
comparisons among unlike species and processes, the Agency decided
against defining small establishments on the basis of production
volume.
(2) Defining ``small'' according to the number of establishment
employees. The Agency rejected this approach because the number of
employees is not a good indicator of the ability of the establishment
to undertake additional financial burdens.
(3) Definitions based on annual sales in dollars. This simple,
across-the board measure appears both reasonable, simple, and fair. For
this reason, the Agency selected this approach, rather than either of
the others discussed, alone or in combination.
For the purposes of HACCP implementation scheduling, FSIS is
proposing that small establishments be defined as those with annual
production valued at or below $2.5 million. Defining a small business
as one with a maximum of $2.5 million in annual sales allows the
maximum time for compliance with the HACCP requirement for a
significant number of establishments, with approximately one-third of
all establishments falling into the ``small'' category. Further, using
the amount of $2.5 million the percentage of slaughter establishments
considered small is roughly the same as the percentage of processing
establishments falling into this category. The proposed definition of a
small establishment will not significantly affect achievement of the
Agency's food safety objectives, because slaughter and processing
establishments in this category together account for less than one
percent of annual meat and poultry production in the United States.
FSIS invites comment on its approach to defining small
establishments.
Regulatory Oversight of the HACCP System
The NACMCF has specifically addressed the subject of the roles of
regulatory agencies with respect to establishments in which HACCP is
the system of process control for food safety (``The Role of Regulatory
Agencies and Industry in HACCP''). FSIS is in general agreement with
that discussion, especially the part that emphasizes that, with respect
to food safety, establishments must operate effective HACCP systems and
the government role should focus on verification that HACCP plans are
working as intended. If the regulatory agency were to take on hazard
identification, determination of CCP's or critical limits,
responsibility for corrective actions or monitoring responsibilities,
it would be undermining the need for the establishment to assume full
responsibility for the processing of safe product through the HACCP
system of process control.
Verification procedures the Agency might use include:
(1) Review of the HACCP plan;
(2) Review of CCP records;
(3) Review of deviations and responses to deviations;
(4) Visual inspections of operations to see if CCP's are under control;
(5) Random sample collection and analysis (including microbial
testing);
(6) Review of critical limits;
(7) Review of written records of establishment verification tasks;
(8) Revalidation of HACCP plans including on-site observations and
complete records review.
FSIS intends to review and revise existing inspection tasks to
assure that [[Page 6821]] they are focused on the CCP's for each of the
processes that will be controlled by HACCP plans. These revised tasks
will be incorporated into the PBIS and become part of regular
assignments for program personnel.
Public Access to Records
There is a broad policy question about public access to
establishment records generated under HACCP. Some groups believe that
any records used by regulatory agencies for making a determination
about the safety of meat and poultry products produced should be made
public to the maximum extent possible. Others take the position that
such broad-scale access compromises establishments' rights to protect
sensitive commercial information from business competitors.
FSIS believes that public access to any records which it generates
itself and any establishment records copied by FSIS as part of its
verification tasks would be governed by the Freedom of Information Act
(FOIA) (5 U.S.C. 552) and the implementing regulations of USDA (7 CFR
Part 1, Subpart A). FOIA exempts particular commercial and financial
information from mandatory release by government agencies. As a
preliminary matter, it appears that at least some elements of HACCP
plans and monitoring records would be considered commercial information
of the kind exempt from disclosure. FSIS is committed to meeting fully
the public disclosure objectives and requirements of the Freedom of
Information Act.
It should be noted that the FOIA presumes that the governmental
agency has both possession and control of the record. Therefore, when
information is obtained from an establishment and is maintained by
FSIS, that information becomes an agency record subject to FOIA. As
previously discussed, the Agency is not proposing that HACCP plans be
submitted for approval. HACCP plans which have been accepted by virtue
of successful process controls will be on file in the establishment and
available for review by FSIS program personnel. Therefore, the
information maintained by the establishments, including monitoring
records, would not be subject to a FOIA request. However, if during
validation of an establishment's HACCP plan, or during an investigation
of an alleged violation, HACCP records are obtained from an
establishment, those records become agency records subject to FOIA.
FSIS invites public comment on the issue of whether broader public
accessibility to an establishment's records is in the public interest,
and, if so, to what extent the records should be required to be
disclosed.
Relationship to Other Process Control Systems
To eliminate duplication, redundancy, and confusion, FSIS is
considering proposing that the mandatory HACCP plan become the only
Agency recognized process control system for health and safety aspects
of the processes/products of each establishment. Those portions of
existing TQC systems or PQC programs that address health and safety
issues would be encompassed within the mandatory HACCP plan. Those
aspects of an establishments operations that are not health-and-safety
related and, therefore, not covered by the HACCP plan would be
monitored by tasks assigned through PBIS at frequencies determined by
the demands of HACCP verification activities. Comments are invited on
this approach.
Enforcement
The enforcement provisions would require that establishments have
verified HACCP plans for their processing operations by the dates
specified for the establishment and process. As noted, the HACCP
requirements would be phased in by having different effective dates--12
months, 18 months, 24 months, 30 months, or 36 months from the date the
final rule is published, depending on the establishment and the
product(s) being produced.
Establishments that fail to have a verified HACCP plan in place for
a processing operation by the date required for that operation would
have its inspection for that process suspended. Similarly, new
establishments and establishments applying for inspection of new
processing operations would be denied inspection services after those
dates unless and until a HACCP plan is in place for that process.
The enforcement provisions also provide that, once adopted, HACCP
plans would still be subject to verification by FSIS. If a HACCP plan
is found by FSIS to be invalid, inspection would be suspended from
existing operations, pending correction of the HACCP plan.
A HACCP plan might be found invalid for one or more of three
reasons: (1) The HACCP plan does not meet the essential requirements
set forth in the regulation; (2) HACCP records are not being maintained
as required by the regulation and/or the plan, preventing validation of
the plan and/or verification of process controls as may be required,
and (3) a processing failure results in the production of adulterated
product.
Suspension of all or a part of an establishment's inspection
services will be made under rules of practice, proposed in Part 335 of
the Federal meat inspection regulations and Subpart W of the poultry
products inspection regulations, requiring notice by FSIS to the
establishment of the reasons for the suspension. The notice also would
specify the processing operations affected (if not the entire
establishment) and the corrective action(s) required before inspection
service would be resumed.
While inspection is suspended, the facilities identified in the
suspension notice could not be used for the production of meat or
poultry products. Furthermore, if product produced prior to the
suspension were suspected of being adulterated, such product would be
retained at the establishment pending disposition by the Program, and
if already shipped, such product would be subject to recall as
necessary to protect public health.
A suspension would be lifted and inspection service restored upon
the designated Program official providing written acknowledgement of
receipt of a modified plan, coupled with a detailed validation of that
plan by a HACCP-trained individual. The modified plan must have been
developed in consultation with that HACCP-trained individual. In the
case of suspension caused by a processing deficiency resulting in
production of adulterated product, a written testing plan would also be
required. The plan must provide for the testing of finished product
produced under the modified plan for chemical or microbial
characteristics, as appropriate, to demonstrate that the process under
the modified plan would correct the identified problem.
Failure to prepare a valid HACCP plan as specified in the notice,
by the time specified in the notice, will result in service on the
establishment of a complaint in accordance with the Uniform Rules of
Practice. Effective upon service of the complaint, inspection service
will be refused or withdrawn pending resolution of any hearing.
Failure to adhere to a modified HACCP plan, and, if applicable,
testing plan, resulting in a repeat of the suspension for the same or a
related deficiency, would in addition to the requirement for another
modified plan, require a Program review of the establishment's
performance under other provisions of the inspection laws before
inspection would be restored. [[Page 6822]] Recurring violations of
fundamental HACCP requirements would be viewed as indicating an
increased likelihood that other violations of inspection requirements
exist and that additional enforcement actions may be required by FSIS.
Finally, in the event the Administrator finds that HACCP records
have been deliberately falsified, the Agency would in addition to any
suspension in effect, issue a complaint for withdrawal of inspection
from the establishment and would refer the case to the Department of
Justice for criminal prosecution.
3. Illustrations of the Application of HACCP
The HACCP approach to process control is systematic and
establishment specific. The generic models prepared by FSIS and NACMCF
to assist federally inspected establishments to develop HACCP plans
would serve as guides for the processes described earlier in this
document. In order to clarify these concepts, some examples are
included to explain the contrast in operations conducted under the
HACCP system from those conducted under the traditional mode of
industry operation. Since each HACCP system is developed by an
individual establishment to fit with its process(es), the following
examples are meant to serve only as illustrations, and are not intended
to serve as prescriptive blueprints for a specific HACCP plan.
When developing a HACCP plan, all aspects of a food's production
must be considered. The development of a HACCP plan begins with the
identification of the product, its distribution, and the intended
consumer of the product. A hazard analysis is conducted, and the plan
is developed by identifying critical control points, monitoring
procedures, critical limits, and the remainder of the seven principles
discussed earlier in this document.
The HACCP system places the responsibility for production of a safe
and unadulterated product with the industry. The HACCP approach allows
the establishment to focus on the process as it is occurring. If
contamination is occurring, it should be immediately identified,
allowing for prompt corrective action as well as providing an
opportunity to determine the cause and take action to prevent a future
recurrence of the problem. In a non-HACCP approach, the establishment
may not discover contamination until much later in the process, if at
all, resulting in delays, the possibility of producing and distributing
unsafe product, and difficulty in implementing preventive measures.
The following are illustrations of the application of existing
generic models and how they can be used by an establishment.
The HACCP System for Beef Slaughter
For beef slaughtering establishments, a generic HACCP plan which
reviews the processing steps of slaughter operations can provide
general guidance for developing an establishment's specific plan. The
goal of HACCP for slaughter operations is to prevent, eliminate, or
reduce both the incidence and levels of microorganisms pathogenic to
humans. While beef slaughter operations do not include a lethal
treatment (e.g., thermal process) that ensures the elimination of
pathogenic microorganisms, a number of the processing steps can be
controlled to minimize microbiological hazards.
A beef slaughter establishment performing a hazard analysis of its
operation may identify several hazards, particularly enteric pathogens,
such as Salmonella. CCP's where Salmonella contamination might occur
can be identified and then controlled by establishing critical limits,
monitoring those limits at an appropriate frequency, and taking
corrective actions when deviations occur. Recordkeeping and
verification procedures would also be identified for these CCP's in the
establishment's specific HACCP plan.
For example, the intestinal tracts of animals can harbor large
populations of enteric pathogens, such as Salmonella, even though the
animals themselves are asymptomatic. As the slaughtered animals are
eviscerated (removal of the intestinal tract and other organs), there
is potential for spreading the Salmonella from the intestinal tract to
the carcass, operator, or equipment, if the intestines are accidentally
cut. Therefore, evisceration would be considered a CCP in a HACCP plan
for beef slaughter.
Critical limits for the evisceration CCP might be zero percent
occurrence of the following defects for a single carcass: fecal
material, ingesta, urine or abscesses. The establishment employee(s)
working at evisceration would monitor by observing carcasses for
contamination defects and would take corrective actions if the critical
limits were exceeded. Corrective actions might include: immediate
trimming of defects on carcasses, additional establishment employees
added to the slaughter line, a reduction in line speed, sanitization of
evisceration tools in 180 deg.F water, and sanitization of contaminated
clothing in 120 deg.F water or appropriate sanitizer.
Records resulting from this CCP might include a random post-
evisceration carcass examination log. Verification might consist of
supervisory review of records and operations, and random examination of
carcasses after evisceration using a sampling plan sufficient to assure
process control.
In a non-HACCP approach, the establishment may discover
contamination from evisceration much later in the process, causing
delays before the contamination is removed and making implementation of
preventive measures difficult.
Removing the hide from cattle is a major source of microbial
contamination during the slaughtering process. Cattle entering the
slaughter establishment carry with them microbial populations
indicative of what occurred during the care and handling of the live
animals. Salmonella and other types of bacteria can be spread during
the skinning process through contact with hide, hands, and various
pieces of equipment. Therefore, skinning would be a CCP in a beef
slaughter HACCP plan.
Methods for control of contamination at skinning might include
adequate training of the person doing the skinning to minimize
contamination, including pulling the hide down and out from the carcass
as opposed to upward and away; positive reinforcement through
appropriate supervision; and proper cleaning and sanitization of
equipment and carcass contact surfaces.
Monitoring at this CCP might include observation of the
effectiveness of the skinning process for each carcass. Ways to ensure
this is working would be to set critical limits. Critical limits for
skinning might include less than or equal to 20 percent of carcasses
with dressing defects.
If this critical limit is exceeded, corrective actions would be
required. These could include: immediate trimming of defects on
carcasses, additional establishment employees added to the slaughter
line, and/or a reduction in line speed.
Records resulting from this CCP might include a random post-
skinning carcass examination log. Verification might consist of a
supervisory review of records, examination of random carcasses after
skinning is complete using a sampling plan sufficient to assure process
control, and reviewing control charts to confirm that sampling
frequency is sufficient to detect 20 percent defect criteria.
Additionally, baseline data might be established for expected bacterial
numbers. Periodic [[Page 6823]] follow-up analyses and trend analysis
might be performed to verify process control.
Other possible CCP's in beef slaughter are described in the
``Generic HACCP for Raw Beef'' (see Appendix).
The HACCP System for Poultry Slaughter
The current systems of postmortem inspection for poultry share
elements of a HACCP system approach, such as critical limits,
monitoring, corrective action plans, recordkeeping, verification tasks,
critical limits or tolerance levels, monitoring tasks, corrective
actions, and recordkeeping. However, these components are not arranged
in the highly organized systematic manner that is evidenced in a HACCP
system.
Major differences between a HACCP system and the present poultry
slaughter systems are hazard identification and analysis, and the
specific identification of critical control points which are not a part
of current poultry slaughter systems. The progression to a HACCP system
in poultry slaughter would cause some significant changes to emerge.
These changes would include more industry involvement and
responsibility for control of processes executed to produce an end
product that is safe, wholesome, and unadulterated.
Under HACCP, the establishment would define processing steps where
control can be exerted to effectively prevent, eliminate, or reduce
food safety hazards. Because Salmonella is a significant microbial
hazard in raw poultry, establishments would be expected to target
measures that prevent contamination and control the growth of
Salmonella throughout the slaughter process.
For example, under a HACCP system, the establishment may set
criteria for maximum permissible levels of Salmonella in a flock
presented for slaughter. CCP's for control of this enteric pathogen may
include requiring that flock health records be reviewed, that the level
of Salmonella on each flock brought for slaughter be monitored, and
that corrective action be taken when appropriate levels are not met.
At evisceration, critical limits would be set for fecal or other
intestinal contamination present on the carcass. Monitoring would be
conducted at a set frequency, the results would be recorded after
observing the carcasses, and corrective action would be taken if the
limits were exceeded.
In addition, control of Salmonella may include targeting the
chlorine level in the rinse water required for automatic evisceration
equipment, the level of antimicrobial treatment in the chiller, and/or
the temperature of the chill water. These would constitute CCP's
identified by the establishment.
Critical limits would be set based on allowable levels and types of
antimicrobials used, monitored by testing at appropriate frequency, and
recorded in a log or other record.
Corrective action taken may include more frequent changes of chill
water, better temperature control to preclude the growth of pathogens,
or use of an alternate antimicrobial rinse.
Currently, some establishments rely on FSIS personnel to detect
contamination by visual examination of the carcass or by using chiller
water temperatures as an indicator of less than satisfactory
conditions. This would occur as a result of end product examination.
The HACCP approach requires the establishment to implement effective
preventive measures.
Industry would follow a similar protocol for all points in the
poultry slaughter process where a potential hazard can be prevented,
eliminated, or reduced to an acceptable level. This demonstrates CCP's
in an establishment-controlled HACCP system.
The HACCP System for Cooked Sausage
For the development of a HACCP plan, an establishment producing a
cooked sausage must evaluate the entire manufacturing process. The
focus of a HACCP plan on the prevention of food safety hazards requires
defining where unsafe conditions can occur, setting target limits, and
defining corrective action.
Cooked sausage is a broad category which includes frankfurters (hot
dogs and wieners), vienna sausage, bologna, knockwurst, braunschweiger
(liver sausage), and similar products. In this example, assume that the
establishment produces bologna.
Because HACCP is a hazard prevention process control system,
processing hazards must now be identified. The finished product--
bologna--is a fully cooked product that can be consumed without further
safety treatment (i.e., cooking).
Consequently, raw materials (meat and other ingredients) must be
handled to reduce the opportunity for microbiological growth. CCP's
requiring limits would include ensuring that incoming ingredients are
adequately packaged to prevent contamination, and perishable
ingredients are kept within temperature limits that assure their
safety.
Cooking is considered a primary kill step in processed products
where microbiological hazards can be controlled. Critical limits must
be set by an establishment to assure that the product has been
sufficiently heat treated to preclude the growth of pathogenic
microorganisms. The manufacturer of a poultry bologna may set 160
deg.F as the critical limit for the internal temperature and test a set
amount of product, recording the internal temperature, time the
temperature was recorded, and the lot number and size.
If the product does not meet the critical limit set by the
establishment, corrective action can be instituted that could include
recooking the lot of product or chilling and reworking the lot into
subsequent production.
The cooling process is another example of a CCP in the processing
of a cooked sausage product. Improper chilling after the lethal heat
treatment is applied can result in the growth of microorganisms
(particularly vegetative spores) which may have survived the heating
process. Improper chilling will permit the growth of these microbes and
render the product unsafe.
The HACCP approach would ensure that an establishment targets
chilling as a CCP, sets critical limits including time and temperature
parameters (e.g., 5 hours to reach and maintain 40 deg.F internally),
monitors the temperature at frequent intervals, records the results,
and takes appropriate corrective action if the critical limit is
exceeded. Corrective action might include recooking the lot of product
and recooling.
In addition to microbial hazards, physical and chemical hazards
must be identified. The use of nitrite in cooked sausages serves two
functions--color development and some protection against the outgrowth
of anaerobic organisms. Under HACCP, an establishment would set a
critical limit for nitrite in the product, monitor the formulation of
each batch of product produced, record the exact amount of each
ingredient used, and take appropriate corrective action if the limit
were exceeded. Corrective action might include the addition of other
ingredients, such as meat, to offset the addition of excess nitrite.
Therefore, it becomes the responsibility of the establishment under
HACCP to identify CCP's, monitoring procedures, and corrective action
that specifies what would happen to product that is or may be affected
and what would happen to prevent the violation from recurring. Finally,
all HACCP plans must identify the documentation that would occur to
[[Page 6824]] verify that the process is operating appropriately.
D. Effective Dates
The proposed requirements for Sanitation SOP's, antimicrobial
treatments, cooling standards for livestock carcasses, and microbial
testing would be effective 90 days after the date of the final rule's
publication in the Federal Register. This would afford those
establishments not yet performing the proposed interventions the time
to make necessary adjustments. Minimal preparation would be required to
begin microbial testing. The requirement to begin tracking test results
in accordance with the moving sums process-control procedures and
reporting the results to FSIS would be effective 6 months after
promulgation of the final rule. FSIS is proposing to hold
establishments accountable for meeting the interim targets for pathogen
reduction beginning 2 years after promulgation of the final rule.
The 6-month Hazard Analysis period would begin no less than 6
months before the HACCP phase-in date, as set forth for each of nine
process categories and for small establishments, as provided in the
proposed 9 CFR 326.7 and 381.607.
FSIS invites comment on these proposed effective dates.
III. Other Issues and Initiatives
A. Legal Authority
The Poultry Products Inspection Act (PPIA) (21 U.S.C. 451 et seq.)
and the Federal Meat Inspection Act (FMIA) (21 U.S.C. 601 et seq.) were
enacted to protect the health and welfare of consumers by assuring that
meat and poultry products distributed in commerce are ``wholesome, not
adulterated, and properly marked, labeled and packaged'' (21 U.S.C.
Secs. 451 and 602). The term ``adulterated'' is defined in the Acts to
include any meat or poultry product that is ``unsound, unhealthful,
unwholesome, or otherwise unfit for human food'' (21 U.S.C. Secs. 453
(g)(3) and 601(m)(3)). Meat and poultry products that bear or contain
any poisonous or deleterious added substance which may render them
injurious to health, and meat and poultry products that bear or contain
inherent substances in sufficient quantity to ordinarily render them
injurious to health are also ``adulterated'' within the meaning of the
Acts (21 U.S.C. Secs. 453(g)(1) and 601(m)(1)).
The term ``adulterated'' is also defined to include meat and
poultry products that have been ``prepared, packed, or held under
insanitary conditions whereby [they] may have become contaminated with
filth, or whereby [they] may have been rendered injurious to health''
(21 U.S.C. Secs. 453(g)(4) and 601(m)(4)). The FMIA specifically
authorizes the Secretary to ``prescribe the rules and regulations of
sanitation under which establishments shall be maintained'' and to
refuse to allow meat or meat food products to be labeled, marked,
stamped, or tagged as ``inspected and passed'' if the sanitary
conditions of the establishment are such that the meat or meat food
products are rendered adulterated (21 U.S.C. Sec. 608). Similarly, the
PPIA requires all official establishments to be operated ``in
accordance with such sanitary practices, as are required by regulations
promulgated by the Secretary'' and authorizes the Secretary ``to refuse
to render inspection to any establishment whose premises, facilities,
or equipment, or the operation thereof, fail to meet the requirements
of this section'' (21 U.S.C. Sec. 456).
In addition to this specific authority, the Secretary has broad
authority under both Acts to promulgate rules and regulations necessary
to carry out the Acts (21 U.S.C. Sec. 463, 621).
Based on these statutory provisions, FSIS is proposing that
establishments take affirmative action, including adherence to
sanitation standard operating procedures, the application of
antimicrobial treatments and microbial testing, the adherence to
cooling requirements for livestock carcasses, and the development and
adherence to HACCP plans, to reduce the occurrence and levels of
pathogenic bacteria on meat and poultry products and to protect the
health and welfare of consumers. FSIS is also proposing, based on these
statutory provisions, to establish interim targets for quantitative
reductions in the incidence of contamination of meat and poultry with
microbial pathogens. These actions to protect public health and improve
the safety of meat and poultry products are authorized by the various
provisions of the Acts referenced above.
B. Improving Food Safety at the Animal Production Stage
There is wide agreement that ensuring food safety requires taking
steps throughout the continuum of production, slaughter, processing,
distribution, and sale of livestock and poultry carcasses and meat and
poultry products to prevent hazards and reduce the risk of foodborne
illness. The U.S. food safety continuum begins on the farm. From there,
animals are transported to markets and then to slaughtering
establishments.
While FSIS is proposing significant enhancement in its regulatory
oversight of FSIS-inspected slaughter and processing establishments,
improving food safety at the animal production stage would require a
different approach. Many producers recognize the need to play an active
role in reducing microbiological and chemical hazards that originate on
the farm. FSIS will work with producers and others to develop and
foster implementation of food safety measures that can be taken on the
farm and prior to the animals entering the slaughter facility to reduce
the risk of harmful contamination of meat and poultry products. Within
this context, the voluntary application of HACCP principles can be
useful in establishing the CCP's within the farm management and live
animal transportation arenas where pathogenic organisms can enter the
food chain.
HACCP principles can be utilized also to structure voluntary
national animal health programs that focus on risk reduction and
producer incentives to reduce the prevalence of a given pathogen. Such
voluntary programs can be built upon similar, successful food safety
efforts presently in use. These include industry-sponsored quality
assurance programs, such as the Milk and Dairy Beef Quality Assurance
Program, a ten-point grassroots education effort by the National Milk
Producers Federation and the American Veterinary Medical Association;
pork and beef quality assurance programs developed by the National Pork
Producers Council and the National Cattlemen's Association; the
American Veal Association's quality assurance program; the GMP
guidelines developed by the National Broiler Council and several
quality assurance efforts by the United Egg Producers; the chemical-
residue avoidance program of the National Turkey Federation; and the
flock health-certification program of the American Sheep Industry
Association. All these programs focus on actions that individual
producers can take to improve the quality and safety of the products
they market. These programs provide a foundation for building future
on-farm food safety initiatives.
There may also be a link between on-farm control measures and the
proposed mandatory implementation of HACCP in FSIS-inspected meat and
poultry establishments. For example, establishments may determine that
the external cleanliness or degree of external contamination of animals
with pathogenic microorganisms at the time the animals enter the
slaughter [[Page 6825]] establishment is a critical control point. This
would require that the establishment and the producer work together to
ensure that an appropriate critical limit has been met. This possible
linkage between in-plant mandatory HACCP and the control practices of
producers simply reflects the reality that improving the safety of meat
and poultry products will require cooperative action across the entire
food system from production on the farm all the way to the consumer.
The expertise and commitment of the producer community will be critical
to making real progress.
FSIS invites comment on the role it can best play to improve food
safety at the animal production stage. Because FSIS resources in this
area are limited, the private sector must continue and perhaps expand
its efforts and initiatives. One role FSIS expects to play is as a
facilitator of research and other activities designed to define
problems and opportunities for improvement and develop animal
production technologies and practices that can improve food safety.
FSIS intends to work closely with academic researchers, other
government agencies, producer groups, and consumer organizations to
help shape an appropriate research agenda and devise effective on-farm
food safety strategies.
FSIS also intends to work closely and cooperatively with producers
and with State health and agricultural officials when outbreaks of
foodborne illness necessitate investigations to trace a safety problem
to its origins which may in some cases be at the animal production
stage. Such investigations are a problemsolving tool intended to assist
public health authorities in controlling an ongoing food safety problem
and finding means to prevent or reduce the likelihood of occurrence of
the problem in the future. Traceback investigations are resource-
intensive and difficult to conduct. They require cooperation among
government agencies at all levels and with the animal production and
processing industries. FSIS invites comment on the appropriate role of
traceback investigations and how they can best be conducted and used to
improve food safety.
C. Transportation, Distribution, Storage, Retail
Just as food safety hazards can arise before animals enter the
slaughterhouse so too can they arise after meat and poultry products
leave FSIS-inspected slaughter and processing establishments. The
transporter, the wholesaler, the retailer, and the food service
industry are important links in the chain of responsibility for food
safety that extends from the farm to the consumer. FSIS has
historically focused on the manufacturing of meat and poultry products,
but the Agency's public health mandate requires that it also work with
the animal production, transportation, distribution, and retail sectors
to implement effective prevention strategies and ensure that the whole
system is working effectively to prevent food safety problems.
FSIS and FDA share authority and responsibility for overseeing the
safety of meat and poultry products after they leave FSIS-inspected
facilities. In accord with the Administration's National Performance
Review, FSIS and FDA have agreed to work together to ensure effective
oversight and the adoption of preventive approaches through the chain
of transportation, distribution, storage, and retail.
FSIS exercises regulatory oversight of meat and poultry products in
transportation, storage, and distribution channels through the
activities of about 130 compliance officers who conduct a nationwide
monitoring program to prevent adulterated or misbranded product from
reaching consumers. FDA also conducts regulatory activities in this
sector. In addition to monitoring retail food safety programs at the
State level, FDA provides technical assistance to States in the form of
a uniform code (the Food Code discussed below) that prescribes
appropriate food handling practices in distribution and retail
channels.
FSIS and FDA will review their respective programs to determine how
they can, considering all of the resources being devoted to this
sector, reconfigure the program or initiate activities to increase
program effectiveness. Two specific areas of review will be
transportation of product in commerce and handling and preparation of
food products by retail stores, restaurants, and institutions.
In the area of transportation, FSIS is currently working with FDA
on the development of guidelines for conveyances used to transport food
products. FSIS and FDA have agreed to:
Ask a group of experts to provide systematic information
on the hazards and controls that currently exist;
Develop practical standards of performance for
establishments and carriers with respect to the transport of food;
Develop a list of Good Manufacturing Practices and options
for encouraging their use;
Initiate joint rulemaking to establish appropriate
standards to ensure the safety of meat and poultry products and other
foods during transport;
Work with the Department of Transportation to implement
the National Food Safety Transportation Act, and investigate whether
additional authority is needed to carry out the shared food safety
mission of FDA and FSIS.
In the area of retail distribution, FSIS has worked closely with
FDA in the recent updating of the Food Code, a set of model ordinances
that serve as a guide for State and local authorities who have primary
responsibility for the regulation of retail stores and restaurants.
FSIS and FDA will continue to work on making the code comprehensive,
focusing on areas of greatest concern, and using existing FDA
mechanisms such as seminars, workshops, and evaluations for getting the
word out in a timely manner on important changes and assuring good
understanding of the practices involved. FSIS and FDA will collaborate
in presenting issues to the Conference for Food Protection and in
responding to the Conference's recommendations, on which the States
vote. In addition, the two agencies will work together to facilitate
State audits, and to provide assistance for whatever changes the audit
results indicate.
FSIS and FDA will also work together to encourage State adoption of
the Food Code as a means to ensure that consistent, science-based food
safety standards are being observed at the retail level across the
country.
D. Health-Based Standards for Pathogenic Microorganisms
Overview
As explained elsewhere in this document, the FSIS food safety
regulatory strategy rests on articulating what constitutes an
acceptable level of food safety performance by meat and poultry
establishments and holding establishments accountable for achieving
that level of performance. The proposed HACCP regulations will provide
the framework for adoption by all meat and poultry establishments of
the science-based preventive controls that will be necessary to achieve
the food safety objectives established by FSIS.
As an initial step toward articulating an acceptable level of food
safety performance and reducing the frequency and degree of
contamination of meat and poultry products with pathogenic
microorganisms, FSIS is proposing to require reductions in the
incidence of one pathogenic microorganism of significant public health
concern, [[Page 6826]] Salmonella, based on what is achievable in the
near term with available science and technology. FSIS may in the future
adjust the interim targets for Salmonella downward, as experience
warrants, and may consider adopting similar technology-based interim
targets for other pathogens.
As explained earlier in this document, FSIS also intends to pursue
over the long term development of science-based food safety performance
standards that are based on what is necessary and appropriate to
protect public health. This is the approach typically taken in the
regulation of chemical residues in food: tolerances are established
that limit the amount of residue that can be lawfully present based on
an assessment of what limit is necessary to ensure the safety of the
food. For certain cooked, ready-to-eat products, and more recently in
the case of E. coli 0157:H7 in raw ground beef, FSIS has determined
that pathogens at any level pose a safety concern and legally
adulterate the product, in effect setting a zero tolerance for such
pathogens.
Other than E. coli 0157:H7 in raw ground beef, a potential hazard
that survives traditional cooking practices followed by many people,
FSIS has not taken this approach with pathogenic microorganisms
contaminating raw meat and poultry products. FSIS has relied in part on
the fact that proper and generally accepted cooking practices kill most
pathogens present in most raw products. It is also believed that for
some important pathogens, such as Salmonella, Staphylococcus aureus and
Bacillus cereus, some minimum number of organisms may be required to
pose a significant threat of illness, although there is much scientific
uncertainty in this area and susceptibility to illness varies among
individuals.
The task of establishing science and public-health based food
safety performance standards for meat and poultry products, such as by
identifying levels of specific pathogens that pose a threat to public
health and requiring that those levels not be exceeded, raises
difficult scientific and public health policy issues. These include
determining the nature of the hazard posed by particular pathogens and
the actual threat to health posed under various conditions of exposure
to the pathogen--an inquiry commonly referred to as risk assessment. In
setting such standards, it also must be determined how protective the
standard is to be: how strong must the assurance of safety be? Is any
degree of risk acceptable? How can potential risks be managed by
quantitative limits, labeling or some combination of measures?
Addressing these public health policy issues is sometimes referred to
as risk management.
FSIS invites public comment on the utility of health-based food
safety performance standards and the issues involved in developing
them. FSIS also intends to hold one or more public meetings to explore
this topic with interested persons and experts in the industry,
scientific, consumer and public health communities. Details on the
time, place, and agenda for such meetings will be published in a future
issue of the Federal Register. While the public health policy issues in
this area are difficult and important, it is necessary first to
consider the scientific basis for setting health-based food safety
performance standards. The following paragraphs describe the current
state of knowledge in this area and some of the scientific issues that
need to be addressed.
Quantitative Risk Assessment for Microbial Pathogens
Integral to development of public health-based food safety
performance standards is an understanding of the relationship between
bacterial levels and the incidence of disease. The likelihood that an
exposure to a foodborne pathogen will produce a disease response in an
individual is dependent on the pathogenicity of the microorganism, the
level of exposure (i.e., number of microorganisms ingested), and the
susceptibility of the host. Qualitative and quantitative consideration
of these factors is the basis for conducting a microbial risk
assessment.
Pathogenicity describes the overall disease-causing capability of a
microorganism. The inherent potential for a microorganism to cause
disease is associated with one or more genetic characteristics (i.e.,
virulence factors). The virulence of a species is reflected in the
levels of the microorganism that are needed to colonize a host and
produce an infection or toxigenic response, as well as the severity
(i.e., medical consequences) of the disease. However, pathogens must
always be considered in the context of their host, since disease
processes are dependent on host/pathogen interactions. In any
population, individuals will have a varied response to any specific
pathogen. This includes both the levels of the pathogen needed to
elicit an infection or morbidity, and the extent and duration of
symptoms. Typically, there will be a distribution of susceptibilities
as a function of the levels of ingested pathogen.
This distribution of the host and pathogen characteristics means
that the potential for infection must be treated as a probability
function. This approach is replacing the older concept of minimum
infectious dose, which fails to take into account the distribution of
susceptibility within the host population. As the number of pathogen
cells to which the host population is exposed increases, there is a
corresponding increase in the probability of infection among the
population.
The amount of data on the quantitative dose-response relations for
human and various foodborne pathogens is severely limited. However,
available data do allow estimation of infection rates for many
foodborne pathogens. In many instances this may be sufficient since,
barring exceptional pathogenic resistance or host susceptibility, the
key data for a microbial risk assessment in foods are estimates of
exposure (i.e., the numbers of pathogens ingested by consumers) and
their correlation with infection rates.
A key limitation on the application of risk assessment techniques
to microbial food safety issues has been that, unlike most chemical
toxins, the levels of bacteria in food are not constant. They can
change drastically as the result of growth or inactivation. The ability
to run risk assessment scenarios to study the potential impact of
changing food processing or food preparation protocols is dependent on
acquiring a reasonable estimate of the levels of a pathogen consumers
are ingesting. The ability to estimate exposure is, in turn, dependent
on being able to estimate (1) The probability that the pathogen is
present in the food ingredients, (2) the initial levels of the pathogen
that can be expected if the microorganism is present, and (3) how these
levels are likely to change as a result of operations associated with
the processing, preparation, and storage of the food. While there are
still methodological limitations, recent advances in predictive
microbiology and the systematic collection of baseline data on the
presence of pathogenic bacteria in foods have begun to allow the first
quantitative microbial risk assessments.
In the case of some significant foodborne illness sources, such as
contamination of raw poultry with Salmonella and Campylobacter, the
illness is more often caused not by direct consumption of the
contaminated food but by cross-contamination of other foods during
handling and preparation. FSIS is not aware of research having been
done to correlate levels of specific [[Page 6827]] pathogens in raw
meat or poultry with the risk of cross-contamination and consequent
illness. Whether experimentally derived or acquired through correlation
of community disease rates and pathogen levels in meat or poultry, FSIS
would be interested in reviewing any available data. At the same time,
recognizing the key nature of such data, FSIS is committed to working
with the CDC and the research community to obtain the necessary
information.
Finally, quantitative risk assessment for pathogenic microorganisms
is complicated by the wide variability in susceptibility to particular
pathogens among individuals and groups of individuals in the
population. It is well known, for example, that the young and the
elderly are at significantly greater risk of serious illness or death
from consumption of E. coli 0157:H7 than the general population. Any
person with a weakened or compromised immune system, whether due to age
or illness, is generally more vulnerable to foodborne illness
associated with pathogenic microorganisms. Thus, in developing the
scientific basis for risk assessment, attention must be paid to these
subpopulations so that any resulting health-based standard will be
adequately protective of the population as a whole.
Future Activities
FSIS intends to work closely with the Centers for Disease Control
and Prevention, the Food and Drug Administration, other public health
agencies, academic scientists, and the industry and consumer
communities to develop the scientific basis for microbial risk
assessment and the creation of health-based performance standards for
pathogenic microorganisms. FSIS recognizes that the scientific issues
are difficult and that it may not be possible in the near term to
establish health-based standards for all pathogens. It is important to
begin this effort, however, because, as progress is made in the near
term toward pathogen reduction on the basis of available technology, it
will be increasingly important to know what constitutes an acceptable
level of food safety performance from a public health perspective.
Health-based performance standards can provide an incentive for further
improvement and progress in reducing pathogenic microorganisms and an
indication of the point beyond which further reduction would be
unlikely to yield a public health gain.
FSIS will seek to stimulate--and to a limited extent conduct and
support--the scientific research needed to develop quantitative risk
assessment methods and databases for pathogenic microorganisms. This
will likely include laboratory research, in-plant studies and
community-based epidemiological studies to evaluate health outcome in
meat and poultry inspection. FSIS intends to use the public meetings
mentioned above to canvass the current state of knowledge in this area
and encourage development of a coherent research agenda that can
contribute to progress in this important area.
E. FSIS Technology Strategy
Overview
FSIS has a longstanding interest in the technologies used in meat
and poultry establishments. The facilities, equipment, and processes
used during slaughter and processing of meat and poultry can
significantly affect the safety, quality and wholesomeness of the
finished product. The safety of the product can be affected adversely
by the wrong technology, such as equipment whose food contact surfaces
cannot be adequately cleaned, or by misuse of a technology, such as a
chemical sanitizer or preservative that is used above established safe
limits.
There are also many technologies that can be used in meat and
poultry establishments to help protect product from physical, chemical,
and biological, especially microbiological, hazards. These include
laboratory and in-plant methods to test for chemicals, animal drugs and
bacteria; technologies for preventing harmful contamination by
pathogenic microorganisms; chemicals or physical treatments that can be
applied to carcasses to reduce pathogens; and equipment to verify
pathology diagnoses.
FSIS currently regulates virtually all substances, processes, and
pieces of equipment found in meat and poultry establishments that might
affect the safety, quality, or wholesomeness of the product, through
either prior approval on a plant-by-plant basis or publication of
generic approvals or lists of approved items. The principle objectives
FSIS pursues with these mechanisms are to ensure that the technology
does what it is claimed to do (especially if the claim is safety
related) but does not jeopardize the safety or wholesomeness of the
product, cause or contribute to economic adulteration, interfere with
FSIS inspection, or jeopardize the safety of inspectors.
Recently, members of the regulated industry have complained that
the Agency's control mechanisms, especially its prior approval
processes, stifle innovation and may retard technological progress that
can improve food safety in such important areas as pathogen reduction.
At the same time, representatives of consumer groups have expressed
concern that technologies claimed to be effective for pathogen
reduction and other important food safety purposes be proven effective
for that purpose and that the scientific processes used by FSIS to
evaluate technologies be more open to public scrutiny and
participation.
FSIS believes that the development and proper use of technology can
contribute significantly to improving the safety of the food supply,
especially with regard to reducing the threat posed by pathogenic
microorganisms; and can, in general, improve the Agency's ability to
carry out its mission. The FSIS food safety strategy depends heavily on
establishing food safety objectives for the meat and poultry industry,
which in turn provide an incentive for industry to innovate to meet
those objectives. To make this strategy work, FSIS must not be an
obstacle to beneficial innovation.
Therefore, FSIS is reviewing its current policies and procedures
governing review and approval of in-plant technologies with the
intention of simplifying them to the maximum extent possible, while
ensuring that important safety and efficacy issues are considered. FSIS
invites comment on its technology strategy, including the issues and
activities outlined below. FSIS also intends to convene one or more
public meetings to gain further input on how it can improve its role in
fostering and overseeing the implementation of new technologies to
improve the safety of meat and poultry products. Some of the Agency's
current perspectives and activities in the area of technology
development and evaluation are outlined below.
Current Perspectives and Activities
As a general rule, the development of technologies required to
produce safe and wholesome products is a responsibility of the meat and
poultry industry and allied enterprises, such as equipment designers
and manufacturers, pharmaceutical companies, analytical laboratories,
manufacturers of non-food compounds, and many others. Innovative
technologies are continually developed by these entities to enhance
productivity and profitability in the meat and poultry industry. FSIS
believes that industry innovation can also be directed to improving
food safety if the right incentives exist. FSIS intends as part of its
long-term food safety strategy to increase the incentive for such
innovation by establishing [[Page 6828]] public health-driven targets,
guidelines, or standards that establishments will be held accountable
for meeting. This should have its greatest impact in slaughter
establishments, where such targets, guidelines, or standards do not
generally exist today.
FSIS will focus its own limited technology development efforts on
tools that can assist the Agency in detecting and evaluating food
safety hazards or addressing other issues within its statutory
responsibility, such as economic adulteration. These efforts have
traditionally included, and will continue to include, the development
of sensitive and reliable analytical methods and diagnostics that can
assist the Agency in verifying the safety of meat and poultry products
and detecting product characteristics of regulatory interest. FSIS will
also continue its efforts to develop tools that it can use to advance
its food safety mission but that require long-term commitment to
develop, such as various computer models on pathogen behavior. In these
cases, the Agency has (1) carried out its own technology development
efforts, as it did in developing quick tests for antibiotics and
species identification; (2) secured the assistance of the Agricultural
Research Service and Cooperative State Research Service, as it has done
with computer modeling of pathogen growth under various times and
temperatures; and (3) occasionally, supported specific work by academic
institutions or other private entities through use of competitive
bidding processes, as it did recently by awarding more than $700,000 in
contracts for development of methods to detect pathogenic
microorganisms.
The resources available to FSIS for such technology development
activities are very limited. Moreover, FSIS has found that there is
often considerable interest within the regulated industry in using
technologies that were originally developed by FSIS. FSIS intends to
explore mechanisms for stimulating private sector investment in
analytical methods and other technologies that can assist the Agency in
its regulatory role but that also can assist the industry in carrying
out its food safety responsibilities.
FSIS believes that its primary role with respect to new in-plant
technologies developed by industry should be to ensure that the
technologies do not interfere with inspection, threaten the safety of
the product, or violate other statutory standards, such as those
concerning economic adulteration.
In some circumstances, the FSIS evaluation of a new technology may
need to consider the efficacy of the technology, that is, its success
in accomplishing its intended objective. For example, if FSIS has a
regulatory requirement for the use of an antibacterial treatment, as is
proposed elsewhere in this document, the Agency will take an evaluative
interest in whether a specific treatment in fact has the intended and
required effect. In addition, if a company intends to make a marketing
claim for a process or technology used in an establishment--such as a
claim that its product is ``pathogen free''--FSIS will require a
demonstration that the claim is valid.
On the other hand, in circumstances where industry interest in the
technology is not based on required or claimed health and safety
effects, but on a productivity concern, FSIS interest will be limited
to ensuring that relevant safety questions have been addressed.
When FSIS makes significant decisions about the safety or
effectiveness of an in-plant technology, it must ensure that its
decisions are scientifically sound and open to appropriate public
scrutiny and participation. An example of how this can be achieved is
the approach taken in an earlier section of this document to inviting
public comment on the possible antimicrobial treatments that might
satisfy the proposed requirement that all meat and poultry
establishments adopt at least one antimicrobial treatment. FSIS invites
comment on this approach and other means for ensuring that its
scientific decisions are sound and open to public scrutiny.
During the past several years, staffs in the Agency have begun
efforts that would permit technological change to proceed more readily
from the development to the implementation stage. The Facilities,
Equipment and Sanitation Division has explained many of the principles
and criteria that it uses to make decisions in publicly available
documents so that they can be readily understood and used by companies
as they plan changes in their physical plants. The Microbiology
Division has provided public notice about the circumstances under which
it will formally evaluate analytical methods that may be useful in the
FSIS program, and it has negotiated a Memorandum of Understanding with
the AOAC Research Institute that will permit manufacturers of test kits
designed for use by the industry to have their technologies evaluated
for that purpose. The Processed Products Inspection Division has
developed guidelines to be used in preparing various required QC
programs. The Slaughter Inspection Standards and Procedures Division
has developed and made available protocol guidelines so that companies
that want to conduct in-plant demonstrations of antimicrobial
treatments will know what is necessary to secure Agency approval.
Providing clear guidance of this kind assists companies in meeting
the Agency's requirements and will continue to be an important part of
FSIS's effort to improve its technology review function. As outlined
below, however, FSIS intends to take a number of additional steps to
help foster development, appropriate review, and prompt implementation
of beneficial new technologies, especially those that can help improve
the safety of meat and poultry products.
Future Agency Activities
As already noted, FSIS is reviewing all of its existing systems of
prior approval or other procedural requirements that are now in place
regarding the development and implementation of technologies in meat
and poultry establishments. The Agency intends to eliminate,
streamline, or otherwise modify its systems and procedures, as
appropriate, to ensure that its legitimate oversight obligations are
met without unduly delaying the introduction of beneficial new
technologies or imposing unnecessary burdens on establishments seeking
to adopt such technologies.
One approach FSIS is considering is a simplified single-stop
approval mechanism for industry-wide application of proven pathogen
reduction technologies, once necessary laboratory and in-plant trials
have been completed and the data have been evaluated. The generic
approvals FSIS recently granted for use of hot water and organic acids
in conjunction with the final carcass wash in beef slaughter
establishments could provide a workable model for expediting the
adoption of pathogen-reducing technological developments. The Agency's
scientific evaluation would be for the purpose of ensuring that
efficacy is demonstrated, that conditions of use are specified so the
technology can be widely replicated, and that verification techniques
are available. Once this scientific evaluation has been completed on a
generic basis, approval for industry-wide use without further
constraints, such as plant-by-plant review, could be granted by the
Administrator or his/her designee. FSIS invites comment on this
approach, including what public process would be appropriate in making
such decisions. [[Page 6829]]
FSIS is also establishing a single point of contact in the Agency
regarding technology development and implementation. This will be the
newly constituted office of technology development in the Science and
Technology Program. This office will serve as the initial point of
contact for all inquiries about technology development, and it will
help coordinate evaluations that involve multiple divisions in the
Agency so that responses to inquiries will be timely and complete.
This office will also coordinate development of, and make available
to interested parties, a single guideline for experimental protocols to
be submitted to the Agency prior to commencing an in-plant study of a
new technology. Some new technologies need to be evaluated in in-plant
trials to determine their safety and effectiveness before they can be
appropriately evaluated by FSIS. The Agency does not intend to impede
those trials, but it must be assured that they produce data that will
be adequate to address the Agency's concerns. Thus, one important
element of the guideline will be a description of the information that
must be submitted to satisfy the Agency's basic safety concerns. For
those circumstances in which the Agency will be evaluating the efficacy
of a technology, the guideline will provide detailed information about
the Agency's expectations for data offered to demonstrate efficacy.
This information will address such areas as the quality of the
experimental design, the necessary quantity and quality of data, the
plan for data analysis, and other relevant elements.
Finally, FSIS intends to interact publicly with the regulated
industry and all interested parties to foster the development of
beneficial new food safety technologies and to improve how the Agency
plays its role in this critical area. In areas where FSIS is engaged in
technology development of its own to advance its regulatory objectives,
the Agency intends to identify research that is needed to support its
efforts. FSIS is also interested in learning more about the
opportunities that exist for improving food safety through the adoption
by establishments of scientifically sound processes and technologies in
both slaughter and processing operations, and the Agency seeks public
input on its effort to improve its systems for reviewing and approving
new technologies. As a first step, FSIS intends to hold a public
meeting on these topics during the comment period on the regulations
proposed elsewhere in this document. Details on the time, place and
agenda for this meeting will be published in a future issue of the
Federal Register.
F. FSIS Inspectional Roles
The current FSIS program, as described in Part I of this document,
is fundamentally an inspection program. It is a program designed to
ensure through inspection that proper sanitary practices are observed,
that organoleptically detectable defects, including diseased and
contaminated carcasses, are excluded from the food supply, and that
other requirements and standards related to safety, economic
adulteration, and misbranding are met.
The long-term FSIS food safety strategy and the HACCP proposal set
forth in this document will bring about substantial change in industry
practice and in the FSIS program, as the Agency clarifies and
reinforces the industry's responsibility for producing safe food,
prepares to play its oversight role to ensure companies are
implementing HACCP properly, and works to ensure that all participants
in the food system--producers, processors, distributors and retailers--
are meeting their food safety responsibilities.
With these changes, inspection of products and practices will
remain central to the FSIS program. HACCP verification will necessarily
expand the roles in-plant inspectors will be called upon to play, and
HACCP will enhance the contribution in-plant inspection can make to
ensuring the safety of food. In addition, the need to address food
safety across the continuum from the farm to the consumer, as discussed
in the preceding sections of this document, raises the question of the
role FSIS inspectional oversight should play outside of slaughter and
processing establishments.
Although the demands that will be placed on the FSIS inspection
force by HACCP and other elements of the Agency's food safety strategy
will develop over the next two to four years, it is important that FSIS
begin considering now the future roles of the FSIS inspection program
and how FSIS can maximize the contribution its inspectors make to
ensuring the safety of the food supply. One of the Agency's most
important challenges and obligations is, by means of training and a
clear definition of roles and responsibilities, to prepare its
workforce to meet the demands of the future.
In the course of developing the food safety strategy and regulatory
proposals set forth in this document, FSIS has consulted with the
National Joint Council (NJC) of Food Inspection Locals of the American
Federation of Government Employees, which represents the Agency's food
inspectors, as well as organizations representing the Agency's
veterinarians (National Association of Federal Veterinarians (NAFV))
and technical and supervisory personnel (Association of Technical and
Supervisory Personnel (ATSP)). The Agency will continue this
consultation throughout the pathogen reduction and HACCP rulemaking
process. FSIS also intends to work closely with the bargaining unit and
the employee organizations in formulating a plan for the optimal
utilization of the Agency's inspectional workforce, and FSIS will
comply fully with its obligations under the Basic Agreement with the
NJC to bargain on matters that impact inspectors.
The Agency's employees and their representatives are strongly
committed to ensuring the safety of the food supply and building the
best possible food safety program. They have a critically important
expertise and perspective that must be brought to bear in developing
optimal roles and responsibilities for FSIS employees.
Many of the current roles of FSIS inspectors are controlled by the
statutory mandates for: (1) Carcass-by-carcass inspection in slaughter
establishments; (2) continuous FSIS inspectional presence in all
processing establishments; and (3) inspectional responsibilities for
non-safety wholesomeness and economic adulteration. FSIS is committed
to carrying out these existing mandates. Moreover, changes in FSIS
inspectional roles will be constrained by the level of resources
available to support the inspection program. Nevertheless, some of the
inspectional issues FSIS expects to be addressing are outlined below.
FSIS recognizes that food safety begins at the original point of
production of the food animal--the farm--and can be affected at every
step along the way, including each step of animal production and
transportation leading to delivery of the animal to the slaughterhouse.
Many in the agricultural producer community have recognized the
potential for applying quality assurance principles, including HACCP,
on the farm to prevent the introduction of potential food safety
hazards at their source. Although the Agency welcomes this initiative,
FSIS does not currently have and does not anticipate on-farm
inspectional authority.
As discussed in Part I, the first point of FSIS inspection is the
antemortem inspection that occurs just before animals enter the
slaughter process. It is appropriate to consider whether FSIS should
broaden its antemortem inspectional oversight of conditions
[[Page 6830]] under which animals are held in the period immediately
before slaughter within its current authority. This is a period during
which the health of the animal and its external cleanliness and degree
of external microbial contamination can be affected in a way that may
adversely affect food safety.
The FSIS in-plant inspectional role will certainly be affected by
adoption and implementation of HACCP. As explained above in the portion
of this preamble relating to the HACCP proposal, FSIS inspectors will
be playing a verification role to ensure that appropriate HACCP plans
are in place, are being implemented properly by the establishment, and
are achieving the desired food safety results. This role will require
increased activity by FSIS inspectors in the areas of records review,
visual process verification, and product sampling. FSIS inspectors
will, in some cases, have to develop new skills to carry out these
activities within the HACCP framework. FSIS will be focusing on the
specific additional tasks FSIS inspectors should be performing under
HACCP and the training and skills that will be required.
FSIS is considering, in concert with FDA, the need for additional
standards and Federal oversight to ensure that food is handled safely
during transportation and distribution from processing establishments
to the retail level. In the case of meat and poultry products, it is
critical that products be shipped and stored in sanitary conditions
and, in many cases, under refrigeration. If Federal standards are
developed in this area, FSIS will have to consider what the role of
Federal inspectors should be in ensuring such standards are met. No
Federal agency would have the inspectional resources to inspect on a
regular basis all of the hundreds of thousands of trucks, trains,
vessels, planes, and storage/distribution facilities in the United
States. FSIS will be considering whether there is an appropriate role
for a targeted approach to inspection or random surveillance
inspection, perhaps in collaboration with State and local food safety
authorities, that would help ensure that safe practices are being
observed at these critical stages of the food safety continuum. FSIS is
interested in determining whether technologies, such as recording
thermometers or temperature indicators on refrigerated trucks, could be
adopted to enhance the roles of some relatively limited, periodic
inspectional oversight and enable FSIS inspectors to work effectively
in this area with inspectors from FDA and from counterpart agencies at
the State and local levels.
At the retail level, FSIS intends to work closely with FDA and
State and local officials and will continue to rely primarily on State
and local authorities for inspectional coverage of restaurants, grocery
stores and other conventional retail outlets. FSIS will be exploring
how FSIS inspectors and field compliance officers can better
collaborate with State and local food safety inspectors and other
officials.
The FSIS inspection program for imported products relies on review
of foreign inspection systems and exporting establishments to ensure
that their approaches to food safety are equal to the U.S. approach,
coupled with limited reinspection of incoming product at the U.S.
border by FSIS inspectors. FSIS currently reinspects approximately 10
percent of import shipments, relying largely on organoleptic inspection
techniques. Foreign establishments exporting to the United States will
be required to adopt the pathogen reduction measures and HACCP
requirements FSIS imposes on domestic establishments pursuant to this
rulemaking. As HACCP develops, FSIS will be considering what effect
adoption of HACCP should have on the nature and frequency of import
inspection, including whether microbial testing should be incorporated,
whether the periodic inspections FSIS currently conducts of foreign
establishments should change, and how FSIS could best gain assurance on
a continuing basis that establishments exporting to the United States
are properly implementing appropriate HACCP plans.
Finally, some groups advocate amendment of the FMIA and PPIA to
alter or repeal the current requirements for carcass-by-carcass and
continuous inspection in meat and poultry establishments. This is
necessarily an issue Congress would have to decide. As discussed in
Part I of this document, carcass-by-carcass and continuous inspection
play an important role in ensuring sanitation compliance is maintained,
excluding diseased animals from the food supply, and detecting and
removing other defects, such as fecal contamination, which are directly
related to food safety. FSIS believes that, under any model of
inspection, these objectives must continue to be met if food safety is
to be ensured and the legitimate expectations of the public concerning
the safety and quality of the food supply are to be satisfied.
Some propose that, with or without any statutory change in the
carcass-by-carcass and continuous inspection mandates, establishments
take more initiative in these areas. FSIS must consider how FSIS
inspectors could verify with an acceptable degree of confidence that
functions currently performed by a Federal inspector are being
performed consistently, with the same rigor and effectiveness, by
establishment employees. If establishment employees take on such
functions currently performed by FSIS employees, consideration will
have to be given as to whether ``whistleblower'' protection, which
would shield them from retaliation of any kind for reporting problems,
should be extended to them.
In general, under its proposed pathogen reduction and HACCP
regulatory initiatives, FSIS will be considering what new inspectional
tools and techniques FSIS should adopt to oversee the safety of meat
and poultry products in a regulatory environment where greater
responsibility for safety is being placed on establishments and their
employees.
FSIS invites comment on these issues and on all aspects of how FSIS
can best make use of its inspectional resources to improve the safety
of meat and poultry products, both within currently inspected
establishments and throughout the continuum from the farm to the
consumer.
IV. Economic Impact Analysis and Executive Orders
A. Executive Order 12866
This proposed rule has been determined to be economically
significant and was reviewed by OMB under Executive Order 12866.
Summary: Preliminary Regulatory Impact Assessment HACCP and Related
Near-Term Initiatives Produce Net Benefit to Society
FSIS has prepared a Preliminary Regulatory Impact Assessment (PRIA)
that evaluates the costs and benefits of a mandatory HACCP regulatory
program and related near-term initiatives for all meat and poultry
establishments under inspection. The PRIA concludes that mandating
HACCP systems would result in net benefits that far exceed industry
implementation and operation costs. Mandatory HACCP Program
implementation at a cost of $2 billion over 20 years is projected to
produce a direct reduction in foodborne illness with public health
benefits estimated at $6-24 billion over 20 years.
The proposed near-term requirements, which would be incorporated
into HACCP, would target pathogen reduction on carcasses and raw
product, currently the products with the least systematically
controlled hazards. The [[Page 6831]] benefits are calculated for the
three most common enteric pathogens of animal origin: Campylobacter
jejuni/coli, E. coli 0157:H7, Salmonella and one environmental pathogen
Listeria monocytogenes. The minimization of risk from these pathogens
which can contaminate meat and poultry during slaughter and processing
would produce a 90 percent reduction in the foodborne illness
attributed to these pathogenic microorganisms. Ten percent of
contamination occurs after the product leaves the manufacturing sector.
Industry costs to develop, implement, and operate HACCP processing
control systems are estimated to total $2 billion over 20 years. The
proposed regulation would redistribute costs in a manner more
acceptable to societal values which have always given priority to
eliminating controllable diseases. Establishments that now have good
processing controls would have relatively few implementation costs,
while establishments that have little or no process control would need
to spend more for compliance.
Market Failure Justifies Regulation of Pathogens
Since all raw meat and poultry products contain microorganisms
which may be pathogens, raw food unavoidably entails some risk to
consumers of pathogen exposure and foodborne illness. The presence and
level of this risk cannot be determined by a consumer since pathogens
are not visible to the naked eye. The societal impact of this food
safety information deficit is a lack of accountability for foodborne
illnesses caused by pathogenic microorganisms. Consumers often cannot
trace a transitory illness to any particular food or even be certain it
was caused by food. Thus, food retailers and restaurateurs are
generally not held accountable by their customers for selling pathogen-
contaminated products and they, in turn, do not hold their wholesale
suppliers accountable either.
This lack of marketplace accountability for foodborne illness means
that meat and poultry producers and processors have little incentive to
incur extra costs for more than minimal pathogen controls. The
widespread lack of information about pathogen sources means that
businesses at every level from farm to final sale can market unsafe
products and not suffer legal consequences or a reduced demand for
their product.
The science and technology required to reduce meat and poultry
pathogens is well established, readily available, and commercially
practical. FSIS has concluded that the lack of consumer information
about meat and poultry product safety and the absence of adequate
incentives for industry to provide more than minimal levels of
processing safety represents a market failure requiring Federal
regulatory intervention. The present combination of market regulation
and industry self-policing has not resolved increasingly apparent
problems with meat and poultry pathogens. Documented cases of foodborne
illness each year, some of which have resulted in death, represent a
public health risk that FSIS has determined to be unacceptable. A
Federal regulatory program that reaches every level of meat and poultry
processing for commerce is the only means available to society for
lowering foodborne pathogen risks to an acceptable level. FSIS further
concludes that a mandatory HACCP regulatory program is the only means
to attain this goal.
Alternatives
Process Control Regulatory Strategy
FSIS has determined that effective process control is needed
throughout the meat and poultry industry in order to minimize pathogen
contamination of food products and lower the risk of subsequent
foodborne illness.
The process control regulatory strategy was evaluated using five
factors for effectiveness:
1. Controls production safety hazards;
2. Reduces foodborne illness;
3. Makes inspection more effective;
4. Increases consumer confidence; and
5. Provides the opportunity for increased productivity.
Using these factors, FSIS has determined that mandatory HACCP
provides the greatest effectiveness.
FSIS examined six other process control approaches before
determining that mandatory HACCP was the most effective means for
industry to eliminate pathogens in meat and poultry:
1. Status quo;
2. Intensify present inspection;
3. Voluntary HACCP regulatory program;
4. Mandatory HACCP regulation with exemption for very small
establishments;
5. Mandatory HACCP regulation only for ready-to-eat products; and
6. Modified HACCP--negative records only.
Each of these alternatives was assessed using the five
effectiveness factors for process control presented in the previous
section. None was determined to meet all five criteria; each was found
to be flawed in meeting one or more of the target factors.
The full text of the Preliminary Regulatory Impact Assessment is
published as a supplement to this document.
B. Executive Order 12778
This proposed rule has been reviewed pursuant to Executive Order
12778, Civil Justice Reform. States and local jurisdictions are
preempted under the FMIA and PPIA from imposing any requirements with
respect to federally inspected premises and facilities, and operations
of such establishments, that are in addition to, or different from,
those imposed under the FMIA or PPIA. States and local jurisdictions
may, however, exercise concurrent jurisdiction over meat and poultry
products that are outside official establishments for the purpose of
preventing the distribution of meat or poultry products that are
misbranded or adulterated under the FMIA or PPIA, or, in the case of
imported articles, which are not at such an establishment, after their
entry into the United States. Under the FMIA and PPIA, States that
maintain meat and poultry inspection programs must impose requirements
on State-inspected products and establishments that are at least equal
to those required under the FMIA and the PPIA. These States may,
however, impose more stringent requirements on such State-inspected
products and establishments.
C. Effect on Small Entities
The Administrator, Food Safety and Inspection Service, has
determined that this proposed rule will have a significant economic
impact on a substantial number of small entities. For purposes of this
proposal, a small entity is defined as an establishment with a sales
volume of meat and/or poultry products of no more than $2.5 million per
year. Based on this criterion, as of November 1994, there are 6,827
small slaughter and/or processing establishments that would be affected
by this proposed rule. This analysis assumes that 5 percent of these
small establishments or 341 establishments are currently operating
under all the proposed requirements. Therefore, for these 341
establishments, this proposed rule would impose no additional costs.
For the remaining 6,486 small establishments, costs would be
incurred as follows:
Near-Term Requirements
1. Sanitation Standard Operating Procedures
Establishments would be required to develop a written plan
addressing the required operating procedures, monitor [[Page 6832]] the
plan, record the results of monitoring, and store any records generated
under the operating procedures. Establishments would also be required
to train one or more individuals to carry out the operating procedures.
Costs for this activity are estimated at $50.4 million.
2. Use of an Antimicrobial Treatment
Establishments would be required to use an antimicrobial treatment
on all meat and poultry carcasses. Of the 1,923 small slaughter
establishments, it is estimated that approximately 70 percent now apply
an antimicrobial treatment to meat and/or poultry carcasses. Therefore,
for these establishments, no additional costs should be incurred. For
those establishments that do not now use an antimicrobial treatment,
costs are estimated at $2.7 million.
3. Time/Temperature Requirements
Establishments would be required to provide written plans for
complying with the proposed time, temperature, and monitoring
requirements for carcasses and raw meat products, or with alternative
procedures which would be permitted under this proposal. The written
plan would include the establishment's designated control points,
corrective actions, and, when applicable, the name of the processing
authority. Some establishments may decide to hire a processing
authority to develop such plans, while others may prepare their own
plan. If an establishment chooses to follow alternative procedures, the
establishment must hire a processing authority to develop the
alternative procedures.
The refrigeration requirements set forth in this proposed rule may
result in costs associated with purchases of refrigeration facilities.
Although all establishments must have cooler rooms and most have
refrigerated vehicles for shipping product, some small establishments
may not have existing refrigeration facilities that would meet the
proposed refrigeration requirements. The number and size of
refrigeration units that may be required would depend on cooler room
sizes and slaughter volumes of individual establishments.
Establishments would be required to monitor the temperatures of
carcasses and raw meat products throughout their operations to ensure
compliance with their plan, and maintain ongoing monitoring records for
the previous 6 months. Costs for time/temperature requirements are
estimated at $28.8 million.
4. Microbiological Testing for Salmonella
Each establishment that slaughters livestock or poultry or produces
raw, ground meat or poultry products would be required to collect and
test one specimen of product per day at the end of the production
process. The specimen would be tested for the presence of Salmonella
(the target organism). Testing could be conducted in the
establishment's own laboratory or in a commercial/contract laboratory.
Results of the testing would be recorded daily. Costs for this activity
are estimated at $91.1 million.
As a general matter, this approach to process control verification
testing provides a very efficient means of determining whether a
slaughter establishment is consistently achieving the interim target
for pathogen reduction. Many slaughter establishments currently conduct
voluntarily, for a variety of purposes, significantly more frequent
microbiological testing, and for many establishments the cost of
testing a single sample per species per day will be relatively small
(approximately $30-35 per sample) in relation to the volume of a day's
production.
For some small FSIS-inspected establishments, however,
microbiological testing may be entirely new, and the cost of testing
will be more significant in relation to the volume of production. For
example, some specialty slaughter plants may slaughter only a few head
of livestock per day and may slaughter multiple species, thus requiring
multiple tests, despite a low volume of production.
FSIS has considered the potential impact of its proposed
microbiological testing requirement on small businesses. FSIS is
considering alternatives to minimize the burden on small establishments
while still achieving the goal of verifying that the establishment's
process control is achieving the interim target for pathogen reduction.
One alternative would be to allow certain small establishments
additional time to prepare for and begin testing. FSIS is proposing
that testing begin 90 days after publication of the final rule. By
extending this period for small establishments, such establishments
would have additional time to prepare for the testing and to find an
efficient means of accomplishing it. In addition, as the testing gets
underway in most establishments and the demand for efficient testing
increases, FSIS expects that the market will respond by producing
increasingly economical test methods for use by establishment personnel
and increasingly low-cost laboratory services for establishments that
choose to contract outside the establishment for microbiological
testing.
Another alternative for reducing the cost burden on small
establishments would be to require less than daily testing to verify
process control. For example, every-other-day testing could reduce
costs by half. This would extend the time required to detect that any
establishment is not achieving the target and to begin corrective
measures.
FSIS invites comment on whether special consideration should be
given to small establishments to reduce the cost burden of testing and
on the alternatives outlined above, as well as any other possible
alternatives. FSIS is particularly interested in comment on the
criteria that should govern eligibility for such special consideration.
As discussed above, for the purpose of allowing small establishments
the maximum 3-year period to comply with the proposed HACCP regulation,
FSIS is proposing to define a ``small'' establishment as one with
annual sales of $2.5 million or below. FSIS invites comment on whether
this would be the right criterion for any special relief regarding
testing or whether an alternative criterion, such as the number of head
or a different dollar volume of sales, should be used.
Long-Term Requirement
Implementation of HACCP Systems
Establishments would be required to develop and implement HACCP
systems. Costs to develop, implement, and monitor HACCP plans for small
establishments are estimated to be $157.6 million. FSIS has determined
that it is reasonable to allow small establishments additional time to
meet the proposed HACCP requirements. Therefore, small establishments
would have 36 months from the publication date of the regulation to
implement their HACCP plan(s).
D. Paperwork Requirements
The paperwork requirements in the current proposal, namely records
and plans, represent an alternative to the current process of
inspection. The industry's documentation of its processes, first in a
plan and thereafter in a continuous record of process performance, is a
more effective food safety approach than the sporadic generating of
information by an inspector. It gives inspectors a much broader picture
of production than they can generate on their own and gives them time
to perform higher priority [[Page 6833]] tasks. At the same time it
gives the managers a better view of their own process and more
opportunity to adjust it to prevent safety defects.
To produce this documentation, all industry managers must learn
about the options and methods for making their processes safer, which
they do not have to do if the inspector appears to be the only one
responsible for finding defects. Therefore, while the proposal contains
increased paperwork burden, it is balanced by a reduction in the number
of face-to-face contacts between management and the inspector that are
required to assure the process is being controlled, so that the
opportunity for better control is accompanied by an increase in
productivity for both inspectors and managers.
In order not to increase the paperwork burden unnecessarily, the
Agency has not required that plans be submitted for prior approval. In
addition, the Agency is considering changing some existing prior
approval programs, which would further reduce the paperwork burden on
industry.
As part of establishments' sanitation requirements, each
establishment would develop and maintain an SOP that would be used by
inspection personnel in performing verification tasks. The SOP's would
specify the cleaning and sanitizing procedures for all equipment and
facilities involved in the production of every product. As part of the
SOP, establishment employees(s) would record results of daily
sanitation checks on a checklist at the frequencies stated in the SOP.
The checklist would include both preoperational sanitation checks and
operational sanitation checks. This checklist would be made available
to Program employees, upon request.
As part of the time and temperature requirements, establishments
would develop, implement, and place on file a written plan to meet the
time and temperature requirements. The plan would include the
establishments designated control points where temperatures would be
measured; monitoring procedures; how recordkeeping activities would be
performed; standards for control points (e.g., cooling rate, holding
temperature, and shipping temperature); corrective actions; and, when
applicable, the name of the processing authority.
Establishment employees would also have to maintain records that
report the maximum temperature of carcasses and raw meat and poultry
products throughout the establishment's operations on a daily basis
with the frequency of monitoring based on the establishment's size and
type of operation. These records would be required to be maintained on
file for 6 months after the temperature measurement, and the records
would be made available to Program employees, upon request.
Additionally, the shipping establishment would be required to record
the date and time of shipment of product on the waybill, running slip,
conductor's card, shipper's certificate, or any other such papers
accompanying the shipment.
As part of microbiological testing, each establishment would
develop written procedures outlining specimen collection and handling.
An establishment may test the specimens in their own laboratory or in a
commercial/contract laboratory. Either an internal or external QA/QC
program with check sample analysis would be required. QA/QC records
must be available to Program employees, upon request.
The laboratory would supply the results on a daily basis to the
establishment. The establishment would be responsible for entering the
results daily into a statistical process control chart. The data and
chart would be available for review by the Inspector in Charge upon
request.
The establishment would notify the Inspector in Charge if the
results of the testing exceed the process control limits. In such
instances, a complete review by the establishment of the production
process would be required. A written report of the evaluation,
including the reason for process failure and proposed corrective
actions, would be submitted to the Inspector in Charge within 14 days
from the day the process exceeded the limits. This report would be
updated on a weekly basis until the process is in control.
For the implementation of HACCP, the establishment would maintain
on file the name and a brief resume of the HACCP-trained individual(s)
who participates in the hazard analysis and subsequent development of
the HACCP plans. Establishments would develop written HACCP plans that
include: Identification of the processing step(s) presents hazard(s);
identification and description of the CCP for each identified hazard;
specification of the critical limit which may not be exceeded at the
CCP, and, if appropriate, a target limit; description of the monitoring
procedure or device to be used; description of the corrective action to
be taken if the limit is exceeded; description of the records which
would be generated and maintained regarding this CCP; and description
of the establishment verification activities and the frequency at which
they are to be conducted. Critical limits which are currently a part of
FSIS regulations or other requirements must be included.
Establishments would keep records for measurements during slaughter
and processing, corrective actions, verification check results, and
related activities that contain the identity of the product, the
product code or slaughter production lot, and the date the record was
made. The information would be recorded at the time that it is
observed, and the record would be signed by the operator or observer.
The HACCP records would be reviewed by an establishment employee
other than the one who produced the record, before the product is
distributed in commerce. If a HACCP-trained individual is on-site, that
person should be this second reviewer. The reviewer would sign the
records. Lastly, HACCP records generated by the processor would be
retained on site for at least 1 year and either on site or in a nearby
location for an additional two years.
The paperwork and recordkeeping requirements contained in this
proposed rule have been submitted to the Office of Management and
Budget for approval under the Paperwork Reduction Act (44 U.S.C. 3501
et seq.). Send written comments to: Office of Management and Budget,
Desk Officer for FSIS, Office of Information and Regulatory Affairs,
Room 3208, New Executive Office Building, Washington, DC 20503, and to
the Clearance Officer, Room 404-W, Administration Building, Washington,
DC 20250.
Imports and Exports
The proposed rules will affect importers and exporters of meat and
poultry to the U.S. The inspection statutes require that imported
product be produced under an inspection system that is equivalent to
the U.S. inspection system. The equivalence of a country's system must
be established by the United States before product can be exported to
the United States. The notion of equivalence has been clarified under
the World Trade Organization (WTO) Agreement on Sanitary and
Phytosanitary measures. Under the WTO all members have an obligation to
apply the principle of equivalence on importing countries. Equivalence
determinations are based on scientific evidence and risk assessment
methodologies.
In light of the WTO emphasis on the use of science to determine
equivalence, a number of countries are moving toward implementation of
HACCP systems.
HACCP and the related near-term initiatives proposed in this
document represent science-based regulation. [[Page 6834]] Upon
implementation of these regulations, FSIS will review other countries'
meat and poultry systems to ensure that exporting countries have
adopted comparable measures, which would entitle them to continue
exporting product to the United States. As other countries improve
their regulations by adopting provisions comparable to those proposed
in this document, it is expected that U.S. exports will similarly be
affected.
FSIS is soliciting comments from all interested parties on how the
proposed rule would affect international trade. FSIS believes that
these improved scientific measures will facilitate trade.
Comments
Interested persons are invited to submit written comments
concerning this proposal and the PRIA. Written comments should be sent
in triplicate to Diane Moore, Docket Clerk, Food Safety and Inspection
Service, U.S. Department of Agriculture, Room 3171-S, Washington, DC
20250. Any person desiring an opportunity for an oral presentation of
views as provided by the Poultry Products Inspection Act should make
such request to the appropriate party listed under FOR FURTHER
INFORMATION CONTACT so that arrangements can be made for such views to
be presented. A record will be made of all views orally presented. All
comments submitted in response to this proposal will be available for
public inspection in the Docket Clerk's office from 8:30 a.m. to 1:00
p.m. and 2:00 p.m. to 4:00 p.m., Monday through Friday.
Copies of documents listed under ``References,'' below, are
available for public inspection in the FSIS Docket Room, USDA, 14th and
Independence Avenue, SW, Room 3175, South Agriculture Building,
Washington, DC 20250.
V. References
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5. Council for Agricultural Science and Technology publication Food
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Journal Milk and Food Technology. 31:302-305.
99. Agriculture Handbook No. 412.
100. Hippe, C.L., R.A. Field, B. Ray and W.C. Russel. 1991. Effect
of spray-chilling on quality of beef from lean and fatter carcasses.
Journal of Animal Science. 69:178-183.
101. Retrum, R. 1958. Beef carcass chilling and holding.
Refrigerating Engineering. 66:63-64, 74-80.
102. Gill, C.O. 1979. A review--Intrinsic bacterial in meat. J.
Appl. Bacteriol. 47:367-378.
103. Vanderzant, C. and R. Nickelson. 1969. A microbiological
examination of muscle tissue of beef, pork and lamb carcasses.
Journal Milk and Food Technology. 32:357-361.
104. Whiting, R.C. and R.L. Buchanan. 1992. Use of microbial
modeling in a HACCP program, Proceedings of the Second ASEPT
International Conference, Predictive Microbiology and HACCP. Laval,
France. 125-141.
105. Hanna, M.O., G.C. Smith, F.K. McKeith and C. Vanderzant. 1982.
Microbial flora of livers, kidneys and hearts from beef, pork and
lamb: Effects of refrigeration, freezing and thawing. J. Food Prot.
45:63-73.
106. Centers for Disease Control and Prevention. 1994. Healthy
People 2000. Atlanta, GA.
107. Nationwide Beef Microbiological Baseline Data Collection
Program: Steers and Heifers, 1992-1993. U.S. Department of
Agriculture/Food Safety Inspection Service.
108. Food Safety Inspection Service. Salmonella in Broilers, a
National Study: 1990-1992. U.S. Department of Agriculture.
109. Food Safety Inspection Service. Nationwide Retail Ground Beef
Microbiological Survey. U.S. Department of Agriculture.
110. Johnston, R.W., S.S. Green, J. Chui, M. Pratt, and J. Rivera.
1982. Incidence of Salmonella in fresh pork sausage in 1979 compared
with 1969. J. Food Sci. 47(4):1369-1371.
111. Estimate based on: Nationwide Beef Microbiological Baseline
Data Collection Program: Steers and Heifers, 1992-1993. U.S.
Department of Agriculture/Food Safety Inspection Service.
112. Lammerding, A.M., M.M. Garcia, E.D. Mann, Y. Robinson, W.J.
Dorward, R.B. Truscott, and F. Tittiger. 1988. Prevalence of
Salmonella and thermophilic Campylobacter in fresh pork, veal, and
poultry in Canada. J. Food Prot. 51(1):47-52.
113. Campbell, D.F., S.S. Green, C.S. Custer, and R.W. Johnston.
1982. Incidence of Salmonella in fresh dressed turkeys raised under
Salmonella-controlled and uncontrolled environments. Poultry Sci.
61:1962-1967.
114. Campbell, D.F., R.W. Johnston, M.W. Wheeler, K.V. Nagaraja,
C.D. Szymansaki, and B.S. Pomeroy. 1984. Effects of evisceration and
cooling processes on the incidence of Salmonella in fresh dressed
turkeys grown under Salmonella-controlled and uncontrolled
environments. Poultry Sci. 63:1069-1072.
115. National Turkey Federation National Survey of the Turkey
Industry.
116. Cox, N.A., J.E. Thomson, and J.S. Bailey. 1981. Sampling of
broiler carcasses for Salmonella with low volume rinse water.
Poultry Sci. 60:768-770.
117. ICMFS. 1974. Microorganisms in Foods 2: Sampling for
Microbiological analyses, principles, and specific applications.
118. FSIS, HACCP-6 Review of HACCP Systems Literature (April, 1994).
119. FSIS, HACCP-7 HACCP Workshops Report Summary (April, 1994).
120. FSIS, HACCP-8 HACCP Workshops Report--Overview and Summary of
the Five HACCP Workshops (April, 1994).
121. FSIS, HACCP-9 HACCP Workshops Reports--Overview of the Five
Workshop Steering Committee Reports (April, 1994).
122. FSIS, HACCP-10 HACCP Workshops Report--Overview of Plant
Adaption Activities (April, 1994).
123. National Advisory Committee on Microbiological Criteria for
Foods (NACMCF). November 1989--Hazard Analysis and Critical Control
Point System.
124. National Advisory Committee on Microbiological Criteria for
Foods (NACMCF). March 1992--Hazard Analysis and Critical Control
Point System. Int. J. Food Micr. 16:1-23.
125. National Advisory Committee on Microbiological Criteria for
Foods (NACMCF). June 1993--Report on Generic HACCP for Raw Beef.
Food Micr. 10: 449-488.
126. National Advisory Committee on Microbiological Criteria for
Foods (NACMCF). June 1993--Report on HACCP for Regulatory Agencies
and Industry. Int. J. Food Micr. 21: 187-195.
127. March 1994--Comments on the FDA Proposed Rule to Establish
Procedures for the Safe Processing and Importing of Fish and Fishery
Products. [[Page 6837]]
128. FSIS--HACCP Round Table, March 30-31, 1994--Summary Report
(April 1994).
129. Office of the U.S. Trade Representation, Executive Office of
the President. General Agreement on Tariffs and Trade; Final Text of
Uruguay Round Agreements as signed April 15, 1994 (GPO: Washington,
D.C. ISBN 0-16-045022-5): p. 69.
VI. Proposed Rules
List of Subjects
9 CFR Part 308
Meat inspection, Sanitation.
9 CFR Part 310
Antimicrobial treatment, Microbial testing, Reporting and
Recordkeeping requirements.
9 CFR Part 318
Meat inspection, Reporting and Recordkeeping requirements,
Reinspection, Processed products, Microbial testing.
9 CFR Part 320
Meat inspection, Reporting and recordkeeping requirements.
9 CFR Part 325
Meat inspection, Reporting and recordkeeping requirements,
transportation.
9 CFR Part 326
Hazard Analysis and Critical Control Point (HACCP) systems, Meat
inspection, Reporting and recordkeeping requirements.
9 CFR Part 327
Imported products, Hazard Analysis and Critical Control Point
(HACCP) systems.
9 CFR Part 381
Sanitation, Antimicrobial treatment, Microbial testing,
Reinspection, Processed products, Reporting and recordkeeping, Hazard
Analysis and Critical Control Point (HACCP) systems, Imports,
Transportation.
For the reasons set forth in the preamble, 9 CFR chapter III is
proposed to be amended as follows:
PART 308--SANITATION
1. The authority citation for part 308 would continue to read as
follows:
Authority: 21 U.S.C. 601-695; 7 CFR 2.17, 2.55.
2. Section 308.3 would be amended by redesignating paragraphs (b)
through (i) as paragraphs (c) through (j), and adding a new paragraph
(b) to read as follows:
Sec. 308.3 Establishments; sanitary conditions; requirements.
* * * * *
(b) The establishment shall develop and maintain written Sanitation
Standard Operating Procedures (Sanitation-SOP's) which must be
available to program employees for verification and monitoring.
Sanitation-SOP's shall at a minimum detail daily sanitation procedures
to be conducted before and during operations, to prevent direct
contamination or adulteration of product(s). Sanitation SOP's must also
identify plant officials responsible for monitoring daily sanitation
activities, evaluating the effectiveness of SOP's, and initiating
corrective actions when needed.
(1) A ``U.S. Rejected'' tag will be attached to the applicable
equipment, utensil, room or compartment if a program employee
determines that the establishment has failed to adhere to the
sanitation SOP's specifically required by FSIS regulations. No
equipment, utensil, room or compartment so tagged shall be used until
reinspected and found acceptable by a Program employee.
(2) The establishment owner or operator shall be responsible for
the establishment's adherence to the SOP's, as well as for all sanitary
requirements specified elsewhere in these regulations. Preoperational
procedures prescribed in the Sanitation-SOP's must be completed before
the start of operations.
(3) The establishment shall develop and maintain a daily record of
completion of all sanitation Standard Operating Procedures. Daily
records, including any deviations from regulatory requirements and
corrective actions taken shall be maintained by the establishment for a
minimum of 6 months.
* * * * *
PART 310--POSTMORTEM INSPECTION
3. The authority citation for part 310 would continue to read as
follows:
Authority: 21 U.S.C. 601-695, 7 CFR 2.17, 2.55.
4. Part 310 would be amended by adding Secs. 310.24 and 310.25 to
read as follows:
Sec. 310.24 Treating carcasses to reduce bacteria.
(a) General. Raw livestock carcasses shall be treated at least once
at any point during the slaughter and dressing operation, but prior to
entering the cooler to reduce levels of bacteria on carcass surfaces.
(b) Treatment methods. Official establishments may use any of the
following treatment methods to reduce bacteria, provided that equipment
has been approved under Sec. 308.5, and that operation of the method
results in full compliance with the Act and this subchapter.
(1) Any chlorine compound approved by the Administrator and
administered to raw, uncooled whole livestock carcasses or major
carcass portions at 20 to 50 parts per million (ppm) in the intake
water at the final wash. The chlorinated water must contact all carcass
surfaces. The Administrator will prepare a list containing compounds
approved for use in official establishments. A copy of the list may be
obtained from the Compounds and Packaging Branch, Produce Assessment
Division, Regulatory Programs, Food Safety and Inspection Service, U.S.
Department of Agriculture, Washington, DC 20250-3700.
(2) Hot water applied such that the temperature of the water at the
carcass surface is 165 deg.F (74 deg.C) for
10 seconds. The hot water must contact all carcass surfaces.
(3) Any antimicrobial compound listed in the table in
Sec. 318.7(c)(4) and permitted for use on livestock products may be
used under the conditions specified therein. The antimicrobial compound
must be administered so that it contacts all carcass surfaces.
(4) Any antimicrobial compound previously approved for use in
livestock or livestock products as a food additive or processing aid by
the Food and Drug Administration and listed in title 21 of the Code of
Federal Regulations, parts 73, 74, 81, 172, 173, 182, or 184 may be
used, provided the owner or operator has received approval for such use
from the Administrator in accordance with Sec. 318.7(a) of this
subchapter. Any such antimicrobial compound must be administered so
that it contacts all carcass surfaces.
(c) Exemptions for exported product. Product designated for export
only to a country which will not accept product exposed to the
antimicrobial treatment installed in the establishment will be exempted
by the inspection program from the requirement for antimicrobial
treatment if the product is properly identified, segregated, and
labeled.
Sec. 310.25 Microbial testing.
(a) General. (1) Incidental sampling. In the event of an outbreak
of foodborne disease or other evidence of a threat to public health
attributable to a meat or meat food product, the Administrator will
conduct a sampling and testing program as may be required. Carcasses at
official establishments may be included in such a sampling and testing
[[Page 6838]] program. Procedures and protocols will vary, depending on
the pathogen of concern and other circumstances.
(2) Rountine sampling. (i) All establishments which have slaughter
operations or produce raw, ground meat or raw sausages are required to
collect a minimum of one sample for testing each day from each
slaughter class and/or species of ground meat. Establishments shall
test the samples for Salmonella species. The results of the analysis
shall be provided to FSIS, as well as to the establishment. The results
of the analysis shall be entered by the establishment in a moving sum
verification chart or table as provided in paragraph (d)(2) of this
section for review by Program employees.
(ii) Establishment must evaluate and improve their process controls
when their performance, as indicated by the number of positive samples
over a specified time, exceeds established acceptable limits.
(iii) Establishments which have adopted a Hazard Analysis and
Critical Control Point system documenting that product being produced
meets or exceeds the established targets for pathogen reduction may,
upon approval by the Administrator, continue their current operating
procedure in lieu of the proposed testing verification program set
forth in paragraph (a)(2)(i) of this section.
(b) Sample collection. (1) Each establishment shall prepare written
procedures outlining specimen collection. Procedures shall address
location(s) of sampling, how sampling randomness is achieved, and
handling of the sample to ensure sample integrity. The written
procedure shall be made available to Program employees for verification
that it is being followed.
(2) The establishment will designate an employee or agent to
collect the specimen, as follows:
(i) Samples from raw carcasses must be taken from chilled product
in the cooler, or if to be used for further processing without cooling,
prior to such further processing. Samples will be excised brisket skin
tissue, 4 inches (10 cm) x 4 inches (10 cm) x \1/2\ inch (1 cm) for
beef and belly skin tissue, and 3 inches (7 cm) x 5 inches (12 cm)
x \1/2\ inch (1 cm) for hogs.
(ii) Samples from raw, ground or comminuted meat products should be
taken prior to packaging. Samples will be \1/2\ pound (0.4 kg).
(c) Analysis. (1) An establishment may test the specimens in its
own laboratory or in a commercial/contract laboratory. However, the
laboratory which is selected must demonstrate experience in testing
meat and poultry for Salmonella spp. Either an internal or external
quality assurance/quality control (QA/QC) program with check sample
analysis is required. QA/QC records must be available to FSIS personnel
and FSIS reserves the right to send official check samples to the
laboratory to verify laboratory capabilities.
(2) The method used for analyzing a sample for Salmonella must be
one of the following:
(i) The method published by FSIS in the current edition of the
Microbiology Laboratory Guidebook. A copy of this method may be
obtained from Microbiology Division, Science and Technology, FSIS,
Washington, DC 20250.
(ii) Any method for Salmonella species recognized by the
Association of Official Analytical Chemists or other scientific body
that may be approved by the Administrator for this purpose. The
analytic method used must be accepted by this third party authority as
being at least as sensitive as the method used by FSIS for official
samples.
(d) Reports and recordkeeping. (1) The designated laboratory or
establishment employee will record the results and supply them on a
daily basis to the establishment. The establishment will provide the
results, at least weekly, to Program employees. The results may be
electronically transmitted.
(2) The establishment will be responsible for entering the results
into a moving sum verification chart or table. The moving sum process
verification chart or table will be maintained by the establishment for
each type of production (slaughter class and/or species of ground
product). This table or chart will consist of a moving sum of results
(i.e., a moving count of positives) that is updated with each new
result. The moving sum procedure is determined by width of window (n)
in terms of number of days' results to include, and maximum acceptable
number of positive samples during that time frame or the Acceptable
Limit.
(i) An example of a moving sum process control chart with the
corresponding decision about process acceptability is given below. In
the example, the window is 8 days (n=8), and the maximum number of
positives permitted in that window is 3 (AL=3).
------------------------------------------------------------------------
Test Moving Comparison Days
Day No. result sum to AL included
------------------------------------------------------------------------
1........................... 0 0 Meets....... 1
2........................... 0 0 Meets....... 1, 2
3........................... 0 0 Meets....... 1 to 3
4........................... 1 1 Meets....... 1 to 4
5........................... 0 1 Meets....... 1 to 5
6........................... 0 1 Meets....... 1 to 6
7........................... 1 2 Meets....... 1 to 7
8........................... 0 2 Meets....... 1 to 8
9........................... 0 2 Meets....... 2 to 9
10.......................... 0 2 Meets....... 3 to 10
11.......................... 0 2 Meets....... 4 to 11
12.......................... 0 1 Meets....... 5 to 12
13.......................... 0 1 Meets....... 6 to 13
14.......................... 0 1 Meets....... 7 to 14
15.......................... 0 0 Meets....... 8 to 15
------------------------------------------------------------------------
Note: Thus, the moving sum value for day 10 is the sum of the results in
the 8 day window ending that day; it can be calculated simply by
counting the number of 1's in the daily result column on days 3
through 10.
[[Page 6839]]
(ii) The chart below specifies the initial values of width of
windows (n) and Acceptable Limit (AL) for each product class.
------------------------------------------------------------------------
Moving sum rules
---------------------------------
Target
Commodity (percent Window
positive size Acceptable
for (n) in limit (AL)
Salmonella) days
------------------------------------------------------------------------
Steers/Heifers........................ 1 82 1
Raw Ground Beef....................... 4 38 2
Cows/Bulls............................ 1 82 1
Hogs.................................. 18 17 4
Fresh Pork Sausages................... 12 19 3
------------------------------------------------------------------------
(e) Corrective action. (1) Establishments failing to meet
Acceptable Limits will be presumed to have process control
deficiencies. In such instances, a complete review by the establishment
of the production process is required. A written report of the
evaluation, including the reason for process failure and proposed
corrective actions, will be submitted to the Inspector in Charge within
14 days from the day the process exceeded the limits. This report shall
be updated on a weekly basis until the moving sum procedure indicates
the process is in control.
(2) During the time the results fail to meet the Acceptable Limits,
sampling should be conducted at a rate of two specimens or more per
day. The sampling rate will return to normal when the establishment
meets Acceptable Limits indicating the process is in control.
PART 318--ENTRY INTO OFFICIAL ESTABLISHMENTS; REINSPECTION AND
PREPARATION OF PRODUCTS
5. The authority citation for part 318 would continue to read as
follows:
Authority: 7 U.S.C. 138f; 7 U.S.C. 450, 1901-1906; 21 U.S.C.
601-695; 7 CFR 2.17, 2.55.
* * * * *
6. Part 318 would be amended by adding a new Sec. 318.25 to read as
follows:
Sec. 318.25 Temperatures and chilling requirements for carcasses and
raw meat products.
(a) Definitions:
Processing authority. A person or organization having expert
knowledge of food processing procedures, having access to facilities
for evaluating the safety of such procedures, and designated by the
establishment to perform certain functions as indicated in this
section.
Raw meat product. Any meat, meat food product, or meat byproduct
that has not received treatment, such as cooking, to make it ready to
eat.
Ready-to-eat-process. Any process, such as cooking, applied to a
raw meat product that effectively inactivates infective pathogenic
hazards that may be in or on the product.
Ready-to-eat product. Any food that is safe for human consumption
without additional treatment.
(b) Time and temperature requirements. (1) All carcasses and raw
meat products from such carcasses shall be cooled to surface
temperatures of 50 deg.F (10 deg.C) or below within 5 hours and
40 deg.F (4.4 deg.C) or below within 24 hours from the time the
carcasses exit the slaughter floor, unless such product immediately
enters a ready-to-eat process or is part of a hot-boning operation, as
prescribed in paragraph (b)(2) of this section. Raw product removed
from the carcass on the slaughter floor not entering a ready-to-eat
process or hot-boning operation, e.g., livers, hearts, and heads with
cheek meat, shall be placed in a chiller within 1 hour of removal from
the carcass.
(2) Establishments that separate raw meat from the bone before
cooling the carcasses (hot-boning) shall cool such raw meat until it
reaches an internal temperature of 50 deg.F (10 deg.C) or below within
5 hours of initial separation, and 40 deg.F within 24 hours, except
that raw meat from a hot-boning operation may enter a ready-to-eat
process at the establishment within 5 hours of initial separation.
(3) Carcasses or raw meat products received at official
establishments shall register an internal temperature of 40 deg.F or
below.
(4) Establishments shall maintain carcasses or raw meat products in
their possession or under their control at a temperature of 40 deg.F or
below. Product may not be released into commerce unless chilled to this
temperature.
(5) Establishments may use a processing authority to develop time
and temperature limits microbiologically equivalent to those provided
in paragraphs 318.25 (b)(1) through (b)(4). Any such time and
temperature alternatives must be included in the establishment's
written plan, as provided in Sec. 318.25(c) of this section.
(c) Temperature monitoring and written plans. (1) Establishments
shall monitor the temperature of raw meat at the control points as set
forth in the establishment's written plan required by paragraph (c)(3)
of this section. Establishments shall make the temperature monitoring
records available to the Program employees and shall retain records up
to 6 months after the temperature measurement or until such time as may
otherwise be specified by the Administrator.
(2) To demonstrate compliance with the time and temperature
requirements set forth in this section, establishments shall use
temperature measuring devices readable and accurate to 2 deg.F
(0.9 deg.C).
(3) Establishments shall develop, implement, and place on file a
written plan for complying with the time and temperature requirements
set forth in this section. Establishments shall make their plans and
records, created under the plans, available to Program employees upon
request. Each plan shall identify the establishment's control points,
i.e., points designated in the production process after the chilling
procedure where temperatures are measured; monitoring procedures,
including frequency within a day's operation; records; standards for
the control points, including cooling rate and holding temperature;
corrective actions, including a system for separating and identifying
noncomplying products; and, when applicable, the name of the processing
authority.
PART 320--RECORDS, REGISTRATION, AND REPORTS
7. The authority citation for part 320 would continue to read as
follows:
Authority: 21 U.S.C. 601-695; 7 CFR 2.17, 2.55.
8. Section 320.1 would be amended by adding new paragraphs (b)
(11), (12), (13) and (14) to read as follows:
Sec. 320.1 Records required to be kept.
* * * * *
(b) * * *
(11) Standard operating procedures (SOP's) for sanitation, and
daily records, as prescribed in Sec. 308.3 of this subchapter.
(12) Temperature control plans and records, as required by
Sec. 318.25 of this subchapter.
(13) A written protocol for sampling raw product for pathogen
testing, as required by Sec. 318.25 of this subchapter.
(14) HACCP plans and records, as required by part 326 of this
subchapter.
9. Section 320.3 would be amended by adding new paragraphs (c), (d)
and (e) to read as follows:
Sec. 320.3 Record retention period.
* * * * * [[Page 6840]]
(c) The Sanitation Standard Operation Procedures for Sanitation
shall be retained as required in Sec. 308.3.
(d) Temperature monitoring plan and records shall be retained as
required in Sec. 318.25(e)(1).
(e) Record of HACCP plans and systems, shall be retained as
required in Sec. 326.6(d).
10. Section 320.6 would be amended by revising paragraph (a) to
read as follows:
Sec. 320.6 Information and reports required from official
establishment operators.
(a) The operator of each official establishment shall furnish to
Program employees accurate information as to all matters needed by them
for making their daily reports of the amount of products prepared or
handled in the departments of the establishment to which they are
assigned and such reports concerning sanitation, antimicrobial
treatments, mandatory microbiological testing, and other aspects of the
operations of the establishment and the conduct of inspection thereat,
as may be required by the Administrator in special cases.
* * * * *
PART 325--TRANSPORTATION
11. The authority citation for part 325 would continue to read as
follows:
Authority: 7 U.S.C. 450, 1901-1906; 21 U.S.C. 601-695; 7 CFR
2.17, 2.55.
12. Section 325.9 would be added to read as follows:
Sec. 325.9 Shipment of carcasses and raw meat products.
(a) Carcasses and raw meat products, as defined in Sec. 318.25 of
this subchapter, shall have an internal temperature of 40 deg.F or
below when loaded on vehicles for shipping. Such products that are
shipped from an official establishment to another official
establishment shall arrive at the receiving establishment at an
internal temperature of 40 deg.F or below.
(b) The date and time of shipment of carcasses and raw meat
products from an official establishment to another official
establishment shall be recorded on the waybill, running slip,
conductor's card, shipper's certificate, or any other such papers
accompanying a shipment.
13. A new part 326 would be added to read as follows:
PART 326--HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP) SYSTEM
Sec.
326.1 Definitions.
326.2 Development of HACCP plan.
326.3 HACCP principles.
326.4 Implementation of the HACCP plan.
326.5 Operation of HACCP system.
326.6 Record review and maintenance.
326.7 Enforcement.
Authority: 21 U.S.C. 601-695; 7 CFR 2.17, 2.55.
Sec. 326.1 Definitions.
For purposes of this part, the following definitions shall apply:
Corrective action. Procedures to be followed when a deviation
occurs.
Criterion. A requirement on which a judgment or decision can be
based.
Critical control point (CCP). A point, step, or procedure at which
control can be applied and a food safety hazard can be prevented,
eliminated, or reduced to acceptable levels.
Critical control point (CCP) failure. Inadequate control at a CCP
resulting in an unacceptable risk of a hazard.
Critical limit. A criterion that must be met for each preventive
measure associated with a CCP.
Deviation. Failure to meet a critical limit.
HACCP. A hazard analysis and critical control point (HACCP) system
that identifies specific hazards and preventive measures for their
control to ensure the safety of food.
HACCP plan. The written document which is based upon the principles
of HACCP and which delineates the procedures to be followed to assure
the control of a specific process or procedure.
HACCP system. The result of the implementation of the HACCP plan.
HACCP-trained individual. A person who has successfully completed a
recognized HACCP course in the application of HACCP principles to meat
processing operations, and who is employed by the establishment. A
HACCP-trained individual must have sufficient experience and training
in the technical aspects of food processing and the principles of HACCP
to determine whether a specific HACCP plan is appropriate to the
process in question.
Hazard. A biological, chemical, or physical property that may cause
a food to be unsafe for consumption.
Hazard analysis. The identification of any biological, chemical, or
physical properties in raw materials and processing steps and an
assessment of their likely occurrence and seriousness to cause the food
to be unsafe for consumption.
Monitor. To conduct a planned sequence of observations or
measurements to assess whether a CCP is under control and to produce an
accurate record for future use in verification.
Preventive measures. Physical, chemical, or other factors that can
be used to control an identified health hazard.
Process. A procedure consisting of any number of separate,
distinct, and ordered operations that are directly under the control of
the establishment employed in the manufacture of a specific product, or
a group of two or more products wherein all CCPs are identical, except
that optional operations or CCPs, such as packaging, may be applied to
one or more of those products within the group.
Product. Any carcass, meat, meat byproduct, or meat food product
capable of use as human food.
Recognized HACCP course. A HACCP course available to meat and
poultry industry employees which satisfies the following: consists of
at least 3 days, 1 day devoted to understanding the seven principles of
HACCP, 1 day devoted to applying these concepts to this and other
regulatory requirements of FSIS, and 1 day devoted to beginning
development of a HACCP plan for a specific process.
Responsible establishment official. The management official located
on-site at the establishment who is responsible for the establishment's
compliance with this part.
Validation. An analysis of verification procedures, HACCP plan
components, and an evaluation of records associated with the HACCP
system to determine its efficacy for the production of safe and
wholesome product for which the process was designed.
Verification. The use of methods, procedures, or tests in addition
to those used in monitoring to determine if the HACCP system is in
compliance with the HACCP plan and/or whether the HACCP plan needs
modification and revalidation.
Sec. 326.2 Development of HACCP plan.
(a) Every official establishment shall develop, implement, and
operate a HACCP plan, as set forth in paragraph (d) of this section,
for each process listed below conducted by the establishment.
Categories of Processes for HACCP:
01 Raw-Ground
02 Raw Other Inclusive
03 Thermally Processed/Commercial Sterile
04 All Other Shelf Stable, Not Heat Treated
05 Fully Cooked--Not Shelf Stable
06 All Other Shelf Stable, Heat Treated
07 All Non-Shelf Stable, Heat Treated, Not Fully Cooked
08 Non-Shelf Stable, w/Secondary Inhibitors
09 Slaughter, All Meat Species
(b) At a minimum, the HACCP plan(s) shall be developed with the
assistance [[Page 6841]] of a HACCP-trained individual employed by the
establishment, whose name and resume is on file at the establishment,
and who is knowledgeable of each process conducted by the
establishment. The person(s) developing the plan shall be knowledgeable
of HACCP and the associated recordkeeping procedures, and shall be
capable of: identifying the hazards of the establishment's process and
understanding the source of such hazards; establishing relevant CCP's
throughout the process; and developing appropriate critical limits,
monitoring procedures, corrective action procedures, verification
procedures and their frequency, and operating procedures to implement
the HACCP plan.
(c) Prior to the initiation of the Hazard Analysis phase for HACCP
plan development, each establishment shall have on file a copy of its
procedures for maintaining adherence to recommended Standard Operating
Procedures for sanitation as set forth in Sec. 308.3.
(d) The development of the HACCP plan shall consist of two stages:
a Hazard Analysis, as provided under Principle 1 in Sec. 326.3(a); and
the development of the remainder of the HACCP plan for each specific
process, as defined in Sec. 326.2(a), including activities designed to
ensure that the HACCP plan as developed is valid. These steps shall be
completed over a period not to exceed 6 months prior to the phase-in
date of the process category as prescribed in Sec. 326.7, or upon
application for the grant of inspection, or when a new process is
intended for implementation.
(1) The HACCP plan should be in a format that is similar to the
National Advisory Committee on Microbiological Criteria for Foods and
FSIS generic models to ensure that both the establishment and program
employees can readily identify the requirements in Secs. 326.2(c) and
326.3.
(2) Each HACCP principle, as prescribed in Sec. 326.3, must be
included in the HACCP plan.
Sec. 326.3 HACCP principles.
The following principles and their associated components shall be
included in each HACCP plan:
(a) Principle No. 1. A hazard analysis shall be conducted to
identify biological (including microbiological), chemical, and/or
physical properties of raw materials and processing steps that may
cause a product or products to be unsafe for consumption. A list of
steps in the process where potentially significant hazards may occur
and the preventive measures to be taken shall be prepared. Hazard
analysis should take into consideration factors such as: ingredients;
physical characteristics and composition; processing procedures,
microbial content of the product or products; facility and equipment
design; packaging; sanitation; conditions of storage between packaging
and the end user; intended use; and intended consumer. All identified
hazards associated with each step in the process must be listed and its
significant risk and severity evaluated. The preventive measures to
control the identified hazards must be listed. The steps in application
of this principle shall, at a minimum, include:
(1) A flow chart describing the steps of each process and product
flow in the establishment; and
(2) Identification of the intended use and consumers of the product
based upon normal use by the general public or a particular segment of
the population.
(b) Principle No. 2. Identify the CCP's in the process using a
decision tree and the information derived from Sec. 326.3(a). CCP's
shall be identified for purposes of product safety only. They must
include physical, chemical, and biological (including microbiological
and residue) hazards; must encompass the health and safety process
control points required by FSIS regulations, or their equivalents; and
must be specified for each identified hazard.
(c) Principle No. 3. Establish specific critical limits for
preventive measures associated with each identified CCP. Critical
limits which are a part of other portions of relevant regulations must
be included.
(1) All critical limits shall meet or exceed any requirement set
forth in this subchapter pertaining to a specific process and which are
currently a part of FSIS regulations or other FSIS requirements.
(2) The responsible establishment official shall ensure that the
critical limits are sufficient to control the identified hazards
through a validation process consisting of verification and monitoring
activities.
(d) Principle No. 4. Establish CCP monitoring requirements.
Establish specific procedures for using the results of CCP monitoring
to adjust and maintain process control.
(1) The responsible establishment official shall ensure that
establishment employees are assigned to monitor each CCP effectively,
as determined by Hazard Analysis.
(2) When monitoring is not possible on a continuous basis, the
monitoring interval established shall reliably indicate that the hazard
can be controlled as demonstrated by process validation performed
during the Hazard Analysis and plan development.
(3) All records and documents associated with CCP monitoring shall
be dated and signed or initialed by the person(s) conducting the
monitoring.
(e) Principal No. 5. Establish corrective action(s) to be taken
when monitoring indicates that there is a deviation from an established
critical limit.
(1) The corrective actions shall describe the step(s) taken to
identify and correct the cause of noncompliance to assure that the CCP
is under control, ensure that no safety hazards exist after these
actions, and define measures to prevent recurrence.
(2) Corrective actions shall include a determination of the effect
of the deviation(s) on product safety; how noncompliant product will be
handled, including segregation and holding procedures; a definition of
lot size; whether the deviation indicates a modification or revision of
the HACCP plan is required, and time frames for modification or
revision of the HACCP plan.
(f) Principal No. 6. Establish effective recordkeeping and
systematic review procedures that document the HACCP system. The
required records are specified in Sec. 326.6.
(g) Principal No. 7. Establish procedures for verification by a
HACCP-trained individual that the HACCP system is functioning
effectively to ensure product safety and process control. This is the
plan validation process and therefore includes methods, procedures, or
tests in addition to those used for monitoring. Such validation shall
ensure:
(1) The adequacy of the critical limits at each CCP;
(2) The continuing effectiveness of the establishment's HACCP plan
and system, including taking into account changes in product volumes,
procedures, personnel, and product use;
(3) The accuracy of the HACCP plan through the completion of all
seven principles and their associated actions including revalidation
whenever significant product, process, deviations, or packaging changes
require modification of the plan; and
(4) The evaluation of product safety in situations where the
establishment identifies deviations from critical limits, all steps
taken in response to a deviation, and the adequacy of the corrective
response. [[Page 6842]]
Sec. 326.4 Implementation of the HACCP plan.
(a) Upon completion of the Hazard Analysis and development of the
HACCP plan, a responsible establishment official shall review and
approve the written plan by signing it.
(b) Upon completion of the Hazard Analysis and development of the
HACCP plan, the establishment shall conduct activities designed to
determine that the HACCP plan is functioning as intended, ensuring the
adequacy of the CCP's, critical limits, monitoring and recordkeeping
procedures, and corrective actions. During this initial HACCP plan
validation period, the establishment shall conduct repeated
verifications and meet frequently with Program employees to assure the
HACCP system is functioning as intended, which shall include a review
of the records generated by the HACCP system.
(c) When an ingredient change, product reformulation, manufacturing
process or procedure modification, equipment change, or any other such
change requires modifications to the establishment's HACCP plan, the
responsible establishment official, in consultation with a HACCP-
trained individual employed by the establishment, shall ensure that the
HACCP plan is modified to reflect such changes. The development of the
modified HACCP plan shall be conducted in accordance with Secs. 326.2
and 326.3.
Sec. 326.5 Operation of HACCP system.
(a) The establishment's HACCP system, as set forth in the
establishment's HACCP plan, shall be operated with the advice and
guidance of a HACCP-trained individual, as defined in Sec. 326.1.
(b) The responsible establishment official shall be held
responsible for the operation of the HACCP system to ensure compliance
with the Act and regulations thereunder. In all respects, however, the
Administrator shall continue to provide the Federal inspection
necessary to carry out the provisions of the Act.
Sec. 326.6 Record review and maintenance.
(a) Each entry on a record maintained under the HACCP plan shall be
made at the time the specific event occurs and include the time
recorded, and the record shall be signed or initialed by the
establishment employee making the entry. Prior to shipping product
produced under each process, the establishment shall review, on a
defined, systematic basis, all processing and production records
associated with the HACCP plan to ensure completeness, to determine
whether all critical limits were met and, if appropriate, corrective
action(s) were taken, including proper disposition of product. This
review shall be conducted, dated, and signed by an individual who did
not produce the record(s), preferably by the HACCP-trained individual,
or the responsible establishment official.
(b) The following records supporting the establishment's HACCP plan
shall be maintained:
(1) The written HACCP plan including all portions of the Hazard
Analysis as prescribed in this part;
(2) Records associated with the monitoring of CCP's, which include
the recording of actual times, temperatures, or other quantifiable
values, as prescribed in the establishment's HACCP plan; corrective
actions, including all actions taken in response to a deviation;
verification procedures and results; product code(s), identity, or
slaughter production lot; and date the record was made; and
(3) Records associated with supporting documentation for the Hazard
Analysis, development of the selected CCP's, critical limits, frequency
of monitoring and verification procedures, and corrective actions
taken.
(c) All such records shall be made available to any Program
employee upon request. A deviation from a critical limit shall be
brought to the attention of the appropriate Program employee promptly.
(d) All records shall be retained at the establishment at all
times, except that records for monitoring CCP's, corrective actions,
and verification procedures shall be retained at the establishment for
no less than 1 year, and for an additional 2 years at the establishment
or other location from which the records can be made available to
Program employees.
Sec. 326.7 Enforcement.
(a) Implementation. (1) The following establishments shall meet the
requirements of this part by the date prescribed:
(i) Estabishments that conduct the following categories of
processes shall comply by [insert date 12 months after publication of
final rule]: Raw, Ground (including mechanically separated (species));
Thermally Processed/Commercially Sterile; and All Other, Shelf Stable,
Heat Treated.
(ii) Establishments that conduct the following categories of
processes shall comply by (insert date 18 months after publication of
final rule): Non-Shelf Stable, Heat Treated, Not Fully Cooked; and
Shelf Stable, Not Heat Treated.
(iii) Establishments that conduct the following categories of
processes shall comply by [insert date 24 months after publication of
final rule]: Fully Cooked, Non-Shelf Stable; and Non-Shelf Stable, with
Secondary Inhibitors.
(iv) Establishments that conduct the following categories of
processes shall meet the requirements of this part by [insert date 30
months after publication of final rule]: Raw, other; and Slaughter, all
livestock.
(v) Small entities that generate less than $2.5 million dollars of
product per year shall comply by [insert date 36 months after
publication of final rule].
(2) Any establishment that obtains Federal inspection on or after
the effective date(s) for the process category(ies) to be conducted
shall conduct a Hazard Analysis, and shall develop and validate its
HACCP plan(s), as set forth in Sec. 326.2(d) of this part, concurrent
with the grant of inspection. Process analysis, as set forth in
Sec. 326.4(c), shall commence after obtaining Federal inspection to
assure compliance with the critical limits of the HACCP plan and that
the HACCP system is functioning as intended.
(3) Any establishment that institutes a new process requiring
development of a HACCP plan on or after the applicable effective
date(s) of this regulation shall conduct all activities required for
hazard analysis, development, and validation of its HACCP plan(s) for
the process category(ies) as set forth in Sec. 326.2(d) of this part,
before commencing production and shall conduct process analyses, as set
forth in Sec. 326.4(b), to assure compliance with the critical limits
of the HACCP plan and that the HACCP system is functioning as intended.
(4) Commencing with the applicable effective date(s), the Program
shall refuse new inspection services requested for, or, using the
procedures in Sec. 335.33, suspend inspection services from
establishments or specific processes within establishments not having
HACCP plans.
(b) Verification. The Program shall verify that HACCP plan(s) are
effective and validated, and otherwise in compliance with this
regulation. Such verification and process validation may include:
(1) Reviewing the HACCP plan,
(2) Reviewing the CCP records,
(3) Reviewing and determining the adequacy of corrective actions
taken when a deviation occurs,
(4) Conducting verification activities to determine whether CCP's
are under control, [[Page 6843]]
(5) Reviewing the critical limits,
(6) Reviewing other records pertaining to the HACCP plan or system,
(7) Random sample collection and analysis to determine the safety
of the product, and/or
(8) On-site observations and records review for revalidation of
HACCP plans.
(c) Suspension, correction of invalid plans. (1) If the Program
finds a HACCP plan to be invalid, inspection service for the process
covered by the HACCP plan will be suspended using the procedures in
Sec. 335.33. The processing facilities identified shall not be used for
production of meat or meat food product pending completion of the
specified corrective action(s), as prescribed (c)(3) of this section
and written acknowledgement thereof by the designated Program official.
Products produced by the process prior to the suspension suspected of
being adulterated shall be retained at the establishment pending
disposition by the Program, and if such product has been shipped, it
shall be subject to voluntary recall as necessary to protect public
health.
(2) A HACCP plan may be found invalid if:
(i) The HACCP plan does not meet the requirements of this part,
(ii) HACCP records are not being maintained as required to validate
the plan or verify process control under the plan, or
(iii) A processing failure results in production of adulterated
product.
(3) Invalid HACCP plans must be corrected by:
(i) Submission to the designated Program official of a written,
detailed verification by a HACCP-trained individual that a modified
HACCP plan has been developed in consultation with that individual and
that, as modified, the plan corrects the deficiencies found, and
(ii) In the case of a processing deficiency resulting in production
of adulterated product, submission to the designated Program official
of and adherence to a written plan for finished product produced under
the modified HACCP plan to be tested by an external laboratory for
chemical or microbial characteristics, at the establishment's expense,
as appropriate to demonstrate that the process under the modified HACCP
plan corrects the identified problem.
(4) If the establishment fails to adhere to the modified HACCP plan
and, if applicable, the testing plan, resulting in a subsequent
suspension of the same process for the same or a related deficiency,
the designated Program official will, upon receipt and before
acknowledgement of any subsequent modified plan(s) under paragraph
(c)(3) of this section, also review the establishment's performance
under the inspection regulations generally and make a written
recommendation to the Administrator whether any additional inspection
or enforcement measures may be required.
PART 327--IMPORTED PRODUCTS
14. The authority citation for Part 327 would continue to read as
follows:
Authority: 21 U.S.C. 601-695, 7 CFR 2.17, 2.55.
15. Section 327.2 would be amended by redesignating paragraph
(a)(2)(ii)(h) as (a)(2)(ii)(i) and by adding a new paragraph
a(2)(ii)(h) to read as follows:
Sec. 327.2 Eligibility of foreign countries for importation of
products into the United States.
* * * * *
(a) * * *
(2) * * *
(ii) * * *
(h) Development and maintenance of a Hazard Analysis and Critical
Control Point (HACCP) system pursuant to part 326 of this subchapter in
each certified establishment;
* * * * *
16. Subpart E of part 335 would be redesignated as subpart F, and a
new subpart E would be added to read as follows:
Subpart E--Rules Applicable to the Suspension of Inspection for
Failure To Have a Validated HACCP Plan
Authority: 21 U.S.C. 601-695; 7 CFR 2.17, 2.55.
Sec. 335.33 Refusal or suspension of inspection service for failure to
comply with HACCP requirements.
(a) In any situation in which the Administrator determines that an
establishment which is applying for inspection or receiving inspection
under Title I of the Federal Meat Inspection Act does not have a valid
HACCP plan as required by Sec. 326.7, he shall refuse to allow said
meat or meat food products to be labeled, marked, stamped, or tagged as
``inspected and passed.'' The Administrator shall notify the applicant
or operator of the establishment, orally or in writing, as promptly as
circumstances permit, of such refusal to inspect and pass the meat or
meat food products and the reasons therefor, and the action which the
Administrator deems necessary to have a valid HACCP plan. In the event
of oral notification, written confirmation shall be given, as promptly
as circumstances permit, to the applicant or operator of the
establishment in the manner prescribed in Sec. 1.147(b) of the Uniform
Rules of Practice (7 CFR 1.147(b)).
(b) If any applicant or operator of an establishment so notified
fails to take the necessary action to have a valid HACCP plan within
the period specified in the notice, the Administrator may issue a
complaint in accordance with the Uniform Rules of Practice. Effective
upon service of the complaint, inspection service shall be refused or
withdrawn from such establishment pending final determination in the
proceeding.
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS
17. The authority citation for Part 381 would continue to read as
follows:
Authority: 7 U.S.C. 138F; 7 U.S.C. 450; 21 U.S.C. 451-470; 7 CFR
2.17, 2.55.
Subpart H--Sanitation
18. Section 381.45 would be revised to read as follows:
Sec. 381.45 Minimum standards for sanitation, facilities and operating
procedures in official establishments.
The provisions of Secs. 381.45 through 381.61, inclusive, shall
apply with respect to all official establishments.
(a) The establishment shall develop and maintain written Sanitation
Standard Operating Procedures (Sanitation SOP's) which must be
available to program employees for verification and monitoring.
Sanitation SOP's shall, at a minimum, detail daily sanitation
procedures to be conducted, before and during operations, to prevent
direct contamination or adulteration of product(s). Sanitation SOP's
must also identify plant officials responsible for monitoring daily
sanitation activities, evaluating the effectiveness of SOP's, and
initiating corrective actions when needed.
(1) A ``US Rejected'' tag will be attached to the applicable
equipment, utensil, room or compartment if a Program employee
determines that the establishment has failed to adhere to the
Sanitation SOP's specifically required by paragraph (a) of this
section. No equipment, utensil, room, or compartment so tagged shall be
used until reinspected and found acceptable by a Program employee. The
establishment shall maintain daily records for a minimum of 6 months.
(2) The establishment owner or operator shall be responsible for
the establishment's adherence to the SOP's, as well as for all sanitary
requirements specified elsewhere in these regulations.
[[Page 6844]] Preoperational procedures prescribed in the Sanitation
SOP's must be completed before the start of operations.
(3) The establishment shall develop and maintain a daily record of
completion of all sanitation Standard Operating Procedures. Daily
records, including any deviations from regulatory requirements and
corrective actions taken, shall be maintained by the establishment for
a minimum of 6 months.
(b) [Reserved]
Subpart I--Operating Procedures
19. Section 381.66 would be amended by revising paragraph (b) to
read as follows:
Sec. 381.66 Temperatures and chilling and freezing procedures.
* * * * *
(b) General chilling requirements--(1) Definitions:
Processing authority. A person or organization having expert
knowledge of food processing procedures, having access to facilities
for evaluating the safety of such procedures, and designated by the
establishment to perform certain functions as indicated in this
section.
Raw poultry product. Any poultry or poultry byproduct that has not
received treatment, such as cooking, to make it ready to eat.
Ready-to-eat process. Any process, such as cooking, applied to a
raw poultry product that effectively inactivates infective pathogenic
hazards that may be in or on the product.
Ready-to-eat product. Any food that is safe for human consumption
without additional treatment.
(2) Time and temperature requirements.
(i) All poultry and poultry products that are slaughtered and
eviscerated in the official establishment shall be chilled immediately
after processing to reach surface temperatures of 50 deg.F (10 deg.C)
or below within 1.5 hours and 40 deg.F (4.4 deg.C) or below within 24
hours from the time that the carcasses exit the slaughter line, unless
such product immediately enters a ready-to-eat process or a hot-boning
operation, as prescribed in paragraph (b)(2)(ii) of this section. Raw
product removed from the carcass on the slaughter line, such as
giblets, shall be placed in a chiller within 1 hour of removal from the
carcass.
(ii) Establishments that separate raw poultry from the bone before
cooling the carcasses (hot-boning) shall cool such raw poultry until it
reaches an internal temperature of 50 deg.F (10 deg.C) or below within
1.5 hours of initial separation, except that raw poultry from a hot-
boning operation may enter a ready-to-eat process at the establishment
within 1.5 hours of initial separation.
(iii) Carcasses or raw poultry products received at official
establishments shall register an internal temperature of 40 deg.F or
below.
(iv) Establishments shall maintain raw poultry carcasses and
products in their possession or under their control at a temperature of
40 deg.F or below. Product may not be released into commerce unless
chilled to this temperature.
(v) Establishments may use a processing authority to develop time
and temperature limits microbiologically equivalent to those provided
in paragraphs 381.66(b)(2)(i) through (b)(2)(iv). Any such time and
temperature alternatives must be included in the establishment's
written plan, as provided in Sec. 381.66(b)(3) of this section.
(3) Temperature monitoring and written plans. (i) Establishments
shall monitor the temperature of raw poultry at the control points as
set forth in the establishment's written plan required by paragraph
(b)(3)(iii) of this section. Establishments shall make the temperature
monitoring records available to Program employees and shall retain
records up to 6 months after the temperature measurement or until such
time as may otherwise be specified by the Administrator.
(ii) To demonstrate compliance with the time and temperature
requirements set forth in this section, establishments shall use
temperature measuring devices readable and accurate to 2 deg.F
(0.9 deg.C).
(iii) Establishments shall develop, implement, and place on file a
written plan for complying with the time and temperature requirements
set forth in this section. Establishments shall make their plans and
records, created under the plans, available to Program employees upon
request. Each plan shall identify the establishment's control points,
i.e., points designated in the production process after the chilling
procedure where temperatures are measured; monitoring procedures,
including frequency within a day's operation; records; standards for
the control points, including cooling rate and holding temperature;
corrective actions, including a system for separating and identifying
noncomplying products; and, when applicable, the name of the processing
authority.
* * * * *
20. Subpart I would be amended by adding a new Sec. 381.69 to read
as follows:
Sec. 381.69 Treating carcasses to reduce bacteria.
(a) General. Raw poultry carcasses shall be treated at least once
at any point during the slaughter and dressing operation, but prior to
entering the chiller to reduce levels of bacteria on carcass surfaces.
(b) Treatment methods. Official establishments may use any of the
following treatment methods to reduce bacteria, provided that equipment
has been approved under Sec. 381.53, and that operation of the method
results in full compliance with the Act and this part.
(1) Any chlorine compound approved by the Administrator and
administered to raw, unchilled whole poultry carcasses or major carcass
portions at 20 to 50 parts per million (ppm) in the intake water at the
final wash. The chlorinated water must contact all carcass surfaces.
The Administrator will prepare a list containing compounds approved for
use in official establishments. A copy of the list may be obtained from
the Compounds and Packaging Branch, Product Assessment Division,
Regulatory Programs, Food Safety and Inspection Service, U.S.
Department of Agriculture, Washington, DC 20250-3700.
(2) Hot water applied such that the temperature of the water at the
carcass surface is 165 deg.F (74 deg.C) for
10 seconds. The hot water must contact all carcass surfaces.
(3) Any antimicrobial compound listed in the table in
Sec. 381.147(f)(4) and permitted for use on poultry products may be
used under the conditions specified therein. The antimicrobial compound
must be administered so that it contacts all carcass surfaces.
(4) Any antimicrobial compound approved for use in poultry or
poultry products as a food additive or processing aid by the Food and
Drug Administration and listed in title 21 of the Code of Federal
Regulations, parts 73, 74, 81, 172, 173, 182, or 184 may be used,
provided the owner or operator has received approval for such use from
the Administrator in accordance with Sec. 381.147(f)(2) of this part.
Any such antimicrobial compound must be administered so that it
contacts all carcass surfaces.
(5) If the application or use of an antimicrobial treatment is
determined by the Inspector in Charge to not conform to approved
parameters, the establishment shall make necessary adjustments within
15 minutes. If adjustments are not made within 15 minutes, the
establishment shall suspend the treatment and shall not process
carcasses until appropriate adjustments are made. If a second
[[Page 6845]] antimicrobial treatment is in place and functioning
properly, the use of the nonconforming antimicrobial treatment may be
discontinued and processing of carcasses may continue. Product not
treated in conformance with approved parameters shall be retained for
disposition by the Inspector in Charge.
(c) Exemptions for exported product. Product designated for export
only to a country which will not accept product exposed to the
antimicrobial treatment installed in the establishment will be exempted
by the inspection program from the requirement for antimicrobial
treatment if the product is properly identified, segregated, and
labeled.
Subpart K--Post Mortem Inspection: Disposition of Carcasses and
Parts
21. In Sec. 381.76, Table 1--Definitions of Nonconformances, would
be amended in paragraph A-1 by removing the word ``feces'', by amending
paragraph A-2 to remove the end note regarding feces, and by removing
paragraph A-8, ``Feces \1/8\'', and renumbering paragraphs
A-9 through A-20 as A-8 through A-19.
22. Section 381.79 would be amended by revising the heading,
redesignating the existing text as paragraph (a), and adding a new
paragraph (b) to read as follows:
Sec. 381.79 Passing of carcasses; microbial testing.
(a) * * *
(b) Microbial Testing--(1) General.
(i) Incidental sampling. In the event of an outbreak of foodborne
disease or other evidence of a threat to public health attributable to
a poultry or poultry food product, the Administrator will conduct a
sampling and testing program as may be required. Poultry at official
establishments may be included in such a sampling and testing program.
Procedures and protocols will vary, depending on the pathogen of
concern and other circumstances.
(ii) Routine sampling.
(A) All establishments that have slaughter operations or produce
raw, ground poultry are required to collect a minimum of one sample for
testing each day from each slaughter class and/or species of ground
poultry. The sample will be tested for Salmonella species. The results
of the analysis will be provided to FSIS, as well as to the
establishment. The results of the analysis will be entered by the
establishment in a moving sum verification chart or table for review by
Program employees.
(B) FSIS will require producers to evaluate and improve their
process controls when their performance, as indicated by the number of
positive samples over a specified time, exceeds established Acceptable
Limits.
(C) Establishments that have adopted a Hazard Analysis and Critical
Control Point system documenting that product being produced meets or
exceeds the established targets for pathogen reduction may, upon
approval by the Administrator, continue their current operating
procedure in lieu of the proposed testing verification program, set
forth in paragraph (b)(1)(ii)(C) of this section.
(2) Sample collection. (i) Each establishment will prepare written
procedures outlining specimen collection. Procedures will address
location(s) of sampling, how sampling randomness is achieved, and
handling of the sample to ensure sample integrity. The written
procedure will be made available to Program employees for verification
that it is being followed.
(ii) The establishment will designate an employee or agent to
collect the specimen, as follows:
(A) Whole birds will be collected at the end of the chilling
process, after the drip line, and rinsed in an amount of buffer
appropriate for the type of bird sampled.
(B) Samples from raw ground poultry will be taken prior to
packaging. Samples will be 1/2 pound (0.4 kg).
(3) Analysis. (i) An establishment may test the specimens in its
own laboratory or in a commercial/contract laboratory. However, the
laboratory which is selected must demonstrate experience in testing
poultry for Salmonella spp. Either an internal or external quality
assurance/quality control (QA/QC) program with check sample analysis is
required. QA/QC records must be available to FSIS employees and FSIS
reserves the right to send official check samples to the laboratory to
verify laboratory capabilities.
(ii) The method used for analyzing a sample for Salmonella must be
one of the following:
(A) The method published by FSIS in the current edition of the
Microbiology Laboratory Guidebook. A copy of this method may be
obtained from the Microbiology Division, Science and Technology, Food
Safety and Inspection Service, Washington, DC 20250.
(B) Any method for Salmonella species recognized by the Association
of Official Analytical Chemists or other recognized scientific body
that may be approved by the Administrator for this purpose. The
analytic method used must be accepted by this third party authority as
being at least as sensitive as the method used by FSIS for official
samples.
(4) Reports and recordkeeping. (i) The designated laboratory or
establishment employee will record the test results and supply them on
a daily basis to the establishment. The establishment will provide the
results, at least weekly, to Program employees. The results may be
electronically transmitted.
(ii) The establishment will be responsible for entering the results
into a moving sum verification chart or table. The verification chart
or table will be maintained by the establishment for each type of
production (slaughter class and/or species of comminuted product). This
chart or table will consist of a moving sum of results (i.e., a moving
count of positives) that is updated with each new result. The moving
sum procedure is determined by width of window (n) in terms of number
of days' results to include, and maximum acceptable number of positives
during that time frame.
(A) An example of a moving sum process control chart with the
corresponding decision about process acceptability is given below. In
the example, the window is 8 days (n=8), and the maximum number of
positives permitted in that window is 3 (AL=3):
------------------------------------------------------------------------
Test Moving Days
Day No. result sum Comparison to AL included
------------------------------------------------------------------------
1................... 0 0 Meets............... 1.
2................... 0 0 Meets............... 1, 2.
3................... 0 0 Meets............... 1 to 3.
4................... 1 1 Meets............... 1 to 4.
5................... 0 1 Meets............... 1 to 5.
6................... 0 1 Meets............... 1 to 6.
7................... 1 2 Meets............... 1 to 7.
8................... 0 2 Meets............... 1 to 8.
9................... 0 2 Meets............... 2 to 9.
[[Page 6846]]
10.................. 0 2 Meets............... 3 to 10.
11.................. 0 2 Meets............... 4 to 11.
12.................. 0 1 Meets............... 5 to 12.
13.................. 0 1 Meets............... 6 to 13.
14.................. 0 1 Meets............... 7 to 14.
15.................. 0 0 Meets............... 8 to 15.
------------------------------------------------------------------------
Note: Thus, the moving sum value for day 10 is the sum of the results in
the 8 day window ending that day; it can be calculated simply by
counting the number of 1's in the daily result column on days 3
through 10.
(B) The following chart specifies the initial values of width of
windows (n) and Acceptable Limits (AL) for each product class:
------------------------------------------------------------------------
Moving sum rules
----------------------------------
Target
Commodity (percent Window
positive size (n) Acceptable
for in days limit (AL)
Salmonella)
------------------------------------------------------------------------
Broilers............................. 25 16 5
Turkeys.............................. 15 15 3
Raw Ground Poultry................... ........... ........ ..........
------------------------------------------------------------------------
(5) Corrective action. (i) Establishments not meeting Acceptable
Limits will be presumed to have process control deficiencies. In such
instances, a complete review by the establishment of the production
process is required. A written report of the evaluation, including the
reason for process failure and proposed corrective actions, will be
submitted to the Inspector in Charge within 14 days from the day the
process exceeded the limits. This report shall be updated on a weekly
basis until the moving sum procedure indicates the process is in
control.
(ii) During the time the results fail to meet the Acceptable
Limits, sampling should be conducted at a rate of two specimens or
more. The sampling rate will return to normal when the establishment
meets Acceptable Limits, indicating the process is in control.
Subpart Q--Records, Registration, and Reports
23. Section 381.175 would be amended by adding new paragraphs (b)
(6), (7), (8) and (9) to read as follows:
Sec. 381.175 Records required to be kept.
* * * * *
(b) * * *
(6) Written Sanitation Standard Operating Procedures, and daily
records, as prescribed in Sec. 381.45 of this part.
(7) Temperature control plans and records, as required by
Sec. 381.66 of this subpart.
(8) Written protocol for sampling raw product for pathogen testing,
as required by Sec. 381.79 of this subpart.
(9) HACCP plans and records, as required by subpart Z of this part.
24. Section 381.177 would be amended by adding new paragraphs (c),
(d) and (e) to read as follows:
Sec. 381.177 Record retention period.
* * * * *
(c) Standard Operating Procedures (SOP) for sanitation shall be
retained as required in Sec. 381.45 of this subchapter.
(d) Temperature monitoring plan and records shall be retained as
required in Sec. 381.66 of this subchapter.
(e) Records of HACCP plans and systems, as required by subpart Z of
this part, shall be retained as required in Sec. 381.606(d).
25. Section 381.180 would be amended by revising paragraph (a) to
read as follows:
Sec. 381.180 Information and reports required from official
establishment operators.
(a) The operator of each official establishment shall furnish to
Program employees accurate information as to all matters needed by them
for making their daily reports of the amount of products prepared or
handled in the departments of the establishment to which they are
assigned and such reports concerning sanitation, antimicrobial
treatments, mandatory microbiological testing, and other aspects of the
operations of the establishment, and the conduct of inspection thereat
as may be required by the Administrator in special cases.
* * * * *
Subpart S--Transportation; Exportation; Sale of Poultry or Poultry
Products
26. Subpart S would be amended by adding a new Sec. 381.188 to read
as follows:
Sec. 381.188 Shipment of raw poultry and poultry products.
(a) Poultry carcasses and poultry products, as defined in
Sec. 381.66 of this part, shall have an internal temperature of
40 deg.F or below when loaded on vehicles for shipping. Such products
that are shipped from an official establishment to another official
establishment shall arrive at the receiving establishment at an
internal temperature of 40 deg.F or below.
(b) The date and time of shipment of carcasses and raw poultry
products from an official establishment to another official
establishment shall be recorded on the waybill, running slip,
conductor's card, shipper's certificate, or any other such papers
accompanying a shipment.
Subpart T--Imported Poultry Products
27. Section 381.196 would be amended by redesignating paragraph
(a)(2)(ii)(h) as paragraph (a)(2)(ii)(i) and by adding a new paragraph
(a)(2)(ii)(h) to read as follows:
Sec. 381.196 Eligibility of foreign countries for importation of
poultry products into the United States.
(a) * * *
(b) * * *
(ii) * * *
(h) Development and maintenance of a Hazard Analysis and Critical
Control Point (HACCP) system pursuant to subpart Z of this part in each
certified establishment; and
* * * * *
Subpart W--Rules of Practice Governing Proceedings Under the
Poultry Products Inspection Act
28. Subpart W would be amended by adding a new undesignated center
heading and a new Sec. 381.237 to read as follows:
Rules Applicable to the Suspension of Inspection for Failure To Have a
Validated HACCP Plan
Sec. 381.237 Refusal or suspension of inspection service under the
PPIA for failure to comply with HACCP requirements.
(a) In any situation in which the Administrator determines that an
establishment which is applying for inspection or receives inspection
under the Poultry Products Inspection Act does not have a valid HACCP
plan as required by Sec. 381.607, he shall refuse to render inspection
at the establishment. [[Page 6847]] The Administrator shall notify the
applicant or operator of the establishment, orally or in writing, as
promptly as circumstances permit, of such refusal and the reasons
therefor, and the action which the Administrator deems necessary to
have valid HACCP plan. In the event of oral notification, written
confirmation shall be given, as promptly as circumstances permit, to
the applicant or operator of the establishment in the manner prescribed
in Sec. 1.147(b) of the Uniform Rules of Practice (7 CFR 1.147(b)).
(b) If any applicant or operator of an establishment so notified
fails to take the necessary action to have a valid HACCP plan within
the period specified in the notice, the Administrator may issue a
complaint in accordance with the Uniform Rules of Practice. Effective
upon service of the complaint, inspection service shall be refused or
withdrawn from such establishment pending final determination in the
proceeding.
30. A new subpart Z would be added to read as follows:
Subpart Z--Hazard Analysis and Critical Control Points (HACCP) System
Sec.
381.601 Definitions.
381.602 Development of HACCP plan.
381.603 HACCP principles.
381.604 Implementation of the HACCP plan.
381.605 Operation of HACCP system.
381.606 Record review and maintenance.
381.607 Enforcement.
Sec. 381.601 Definitions.
For purposes of this subpart, the following definitions shall
apply:
Corrective action. Procedures to be followed when a deviation
occurs.
Criterion. A requirement on which a judgment or decision can be
based.
Critical control point (CCP). A point, step, or procedure at which
control can be applied and a food safety hazard can be prevented,
eliminated, or reduced to acceptable levels.
Critical control point (CCP) failure. Inadequate control at a CCP
resulting in an unacceptable risk of a hazard.
Critical limit. A criterion that must be met for each preventive
measure associated with a CCP.
Deviation. Failure to meet a critical limit.
HACCP. A hazard analysis and critical control point (HACCP) system
that identifies specific hazards and preventive measures for their
control to ensure the safety of food.
HACCP plan. The written document which is based upon the principles
of HACCP and which delineates the procedures to be followed to assure
the control of a specific process or procedure.
HACCP-trained individual. A person who has successfully completed a
recognized HACCP course in the application of HACCP principles to
poultry processing operations, and who is employed by the
establishment. A HACCP-trained individual must have sufficient
experience and training in the technical aspects of food processing and
the principles of HACCP to determine whether a specific HACCP plan is
appropriate to the process in question.
HACCP system. The result of the implementation of the HACCP plan.
Hazard. A biological, chemical, or physical property that may cause
a food to be unsafe for consumption.
Hazard Analysis. The identification of any biological, chemical, or
physical properties in raw materials and processing steps and an
assessment of their likely occurrence and seriousness to cause the food
to be unsafe for consumption.
Monitor. To conduct a planned sequence of observations or
measurements to assess whether a CCP is under control and to produce an
accurate record for future use in verification.
Preventive measures. Physical, chemical, or other factors that can
be used to control an identified health hazard.
Process. A procedure consisting of any number of separate,
distinct, and ordered operations that are directly under the control of
the establishment employed in the manufacture of a specific product, or
a group of two or more products wherein all CCP's are identical, except
that optional operations or CCP's, such as packaging, may be applied to
one or more of those products within the group.
Product. Any carcass, poultry, poultry byproduct, or poultry food
product capable of use as human food.
Recognized HACCP course. A HACCP course available to meat and
poultry industry employees which satisfies the following: consists of
at least 3 days, 1 day devoted to understanding the seven principles of
HACCP, 1 day devoted to applying these concepts to this and other
regulatory requirements of FSIS, and 1 day devoted to development of a
HACCP plan for a specified process.
Responsible establishment official. The management official located
on-site at the establishment who is responsible for the establishment's
compliance with this part.
Validation. An analysis of verification procedures, HACCP plan
components, and an evaluation of records associated with the HACCP
system to determine its efficacy for the production of safe and
wholesome product for which the process was designed.
Verification. The use of methods, procedures, or tests in addition
to those used in monitoring to determine if the HACCP system is in
compliance with the HACCP plan and/or whether the HACCP plan needs
modification and revalidation.
Sec. 381.602 Development of HACCP plan.
(a) Every official establishment shall develop, implement, and
operate a HACCP plan, as set forth in paragraph (c) of this section,
for each process listed below conducted by the establishment.
Categories of Processes for HACCP:
01 Raw-Ground
02 Raw Other--Inclusive
03 Thermally Processed/Commercially Sterile
04 All Other Shelf Stable, Not Heat Treated
05 Fully Cooked--Not Shelf Stable
06 All Other Shelf Stable, Heat Treated
07 All Non-Shelf Stable, Heat Treated, Not Fully Cooked
08 Non-Shelf Stable, w/Secondary Inhibitors
09 Slaughter--All Poultry Kind
(b) At a minimum, the HACCP plan(s) shall be developed with the
assistance of a HACCP-trained individual employed by the establishment,
whose name and resume is on file at the establishment, and who is
knowledgeable of each process conducted by the establishment. The
person(s) developing the plan shall be knowledgeable of HACCP and the
associated recordkeeping procedures, and shall be capable of:
identifying the hazards of the establishment's process and of
understanding the source of such hazards; establishing relevant CCP's
throughout the process; and developing appropriate critical limits,
monitoring procedures, corrective action procedures, verification
procedures and their frequency, and operating procedures to implement
the HACCP plan.
(c) Prior to the initiation of the Hazard Analysis phase of HACCP
plan development, each establishment shall have on file a copy of its
procedures for maintaining adherence to recommended Standard Operating
Procedures for sanitation as set forth in Sec. 381.45.
(d) The development of the HACCP plan shall consist of two stages:
a Hazard Analysis, as provided under Principle 1 in Sec. 381.603(a);
and the development of the remainder of the HACCP plan for each
specific process as defined in Sec. 381.602(a), including activities to
ensure that the HACCP plan, as developed, is valid. These steps shall
be completed over a period not to [[Page 6848]] exceed 6 months prior
to the phase-in date of the process category, as prescribed in
Sec. 381.607, or upon application for the grant of inspection, or when
a new process is intended for implementation.
(1) The HACCP plan should be in a format that is similar to the
National Advisory Committee on Microbiological Criteria for Foods and
FSIS generic models to ensure that both the establishment and program
employees can readily identify the requirements in Secs. 381.602(c) and
381.603.
(2) Each HACCP principle, as prescribed in Sec. 381.603 must be
included in the HACCP plan.
Sec. 381.603 HACCP principles.
The following principles and associated components shall be
included in each HACCP plan:
(a) Principle No. 1. A hazard analysis shall be conducted to
identify biological (including microbiological), chemical, and/or
physical properties of raw materials and processing steps that may
cause a product or products to be unsafe for consumption. A list of
steps in the process where potentially significant hazards may occur
and the preventive measures to be taken shall be prepared. Hazard
analysis should take into consideration factors such as: ingredients;
physical characteristics and composition; processing procedures;
microbial content of the product or products; facility and equipment
design; packaging; sanitation; conditions of storage between packaging
and the end user; intended use; and intended consumer. All identified
hazards associated with each step in the process must be listed and its
significant risk and severity evaluated. The preventive measures to
control identified hazards must be listed. The steps in application of
this principle shall, at a minimum, include:
(1) A flow chart describing the steps of each process and product
flow in the establishment; and
(2) Identification of the intended use and consumers of the product
based upon normal use by the general public or a particular segment of
the population.
(b) Principle No. 2. Identify the CCP's in the process using a
decision tree and the information derived from Sec. 381.603(a). CCP's
shall be identified for purposes of product safety only. They must
include physical, chemical, and biological (including microbiological
and residue) hazards; must encompass the health and safety process
control points required by FSIS regulations, or their equivalents; and
must be specified for each identified hazard.
(c) Principle No. 3. Establish specific critical limits for
preventive measures associated with each identified CCP. Critical
limits which are a part of other portions of relevant regulations must
be included.
(1) All critical limits shall meet or exceed any requirement set
forth in this part pertaining to a specific process and which are
currently a part of FSIS regulations or other FSIS requirements.
(2) The responsible establishment official shall ensure that the
critical limits are sufficient to control the identified hazards
through a validation process consisting of verification and monitoring
activities.
(d) Principle No. 4. Establish CCP monitoring requirements.
Establish specific procedures for using the results of CCP monitoring
to adjust and maintain process control.
(1) The responsible establishment official shall ensure that
establishment employees are assigned to monitor each CCP effectively,
as determined by Hazard Analysis.
(2) When monitoring is not possible on a continuous basis, the
monitoring interval established shall reliably indicate that the hazard
can be controlled as demonstrated by process validation performed
during the Hazard Analysis and plan development.
(3) All records and documents associated with CCP monitoring shall
be dated and signed or initialed by the person(s) conducting the
monitoring.
(e) Principle No. 5. Establish corrective action(s) to be taken
when monitoring indicates that there is a deviation from an established
critical limit.
(1) The corrective actions shall describe the step(s) taken to
identify and correct the cause of noncompliance to assure that the CCP
is under control, ensure that no safety hazards exist after these
actions, and define measures to prevent recurrence.
(2) Corrective actions shall include a determination of the effect
of the deviation(s) on product safety; how noncompliant product will be
handled, including segregation and holding procedures; a definition of
lot size; whether the deviation indicates a modification or revision of
the HACCP plan is required; and time frames for modification or
revision of the HACCP plan.
(f) Principle No. 6. Establish effective recordkeeping and
systematic review procedures that document the HACCP system. The
required records are specified in Sec. 381.606.
(g) Principle No. 7. Establish procedures for verification by a
HACCP-trained individual that the HACCP system is functioning
effectively to ensure product safety and process control. This is the
plan validation process and therefore includes methods, procedures, or
tests in addition to those used for monitoring. Such validation shall
ensure:
(1) The adequacy of the critical limits at each CCP;
(2) The continuing effectiveness of the establishment's HACCP plan
and system, including taking into account changes in production
volumes, procedures, personnel, and product use;
(3) The accuracy of the HACCP plan through the completion of all
seven principles and their associated actions including revalidation
whenever significant product, process, deviations, or packaging changes
require modification of the plan; and
(4) The evaluation of product safety in situations where the
establishment identifies deviations from critical limits, all steps
taken in response to a deviation, and the adequacy of the corrective
response.
Sec. 381.604 Implementation of the HACCP plan.
(a) Upon completion of the Hazard Analysis and development of the
HACCP plan, a responsible establishment official shall review and
approve the written plan by signing it.
(b) Upon completion of the Hazard Analysis and development of the
HACCP plan, the establishment shall conduct activities designed to
determine that the HACCP plan is functioning as intended, ensuring the
adequacy of the CCP's, critical limits, monitoring and recordkeeping
procedures, and corrective actions. During this initial HACCP plan
validation period, the establishment shall conduct repeated
verifications and meet frequently with Program employees to assure the
HACCP system is functioning as intended, which shall include a review
of the records generated by the HACCP system.
(c) When an ingredient change, product reformulation, manufacturing
process or procedure modification, equipment change, or any other such
change requires modifications to the establishment's HACCP plan, the
responsible establishment official, in consultation with a HACCP-
trained individual employed by the establishment, shall ensure that the
HACCP plan is modified to reflect such changes. The development of the
modified HACCP plan shall be [[Page 6849]] conducted in accordance with
Secs. 381.602 and 381.603.
Sec. 381.605 Operation of HACCP system.
(a) The establishment's HACCP system, as set forth in the
establishment's HACCP plan, shall be operated with the advice and
guidance of a HACCP-trained individual as defined in Sec. 381.601(i).
(b) The responsible establishment official shall be held
responsible for the operation of the HACCP system to ensure compliance
with the Act and regulations thereunder. In all respects, however, the
Administrator shall continue to provide the Federal inspection
necessary to carry out the provisions of the Act.
Sec. 381.606 Record review and maintenance.
(a) Each entry on a record maintained under the HACCP plan shall be
made at the time the specific event occurs and include the time
recorded, and the record shall be signed or initialed by the
establishment employee making the entry. Prior to shipping product
produced under each process, the establishment shall review, on a
defined, systematic basis, all processing and production records
associated with the HACCP plan to ensure completeness, to determine
whether all critical limits were met and, if appropriate, corrective
action(s) were taken, including proper disposition of product. This
review shall be conducted, dated, and signed by an individual who did
not produce the record(s), preferably by the HACCP-trained individual,
or the responsible establishment official.
(b) The following records supporting the establishment's HACCP plan
shall be maintained:
(1) The written HACCP plan including all portions of the Hazard
Analysis as prescribed in this subpart;
(2) Records associated with the monitoring of CCP's, which include
the recording of actual times, temperatures, or other quantifiable
values, as prescribed in the establishment's HACCP plan; corrective
actions, including all actions taken in response to a deviation;
verification procedures and results; product code(s) identity, or
slaughter production lot; and date the record was made; and
(3) Records associated with supporting documentation for the Hazard
Analysis, development of the selected CCP's, critical limits, frequency
of monitoring and verification procedures, and corrective actions
taken.
(c) All such records shall be made available to any Program
employee upon request. Documents associated with a deviation from a
critical limit shall be brought to the attention of the appropriate
Program employee promptly.
(d) All records shall be retained at the establishment at all
times, except that records for monitoring CCP's, corrective actions,
and verification procedures shall be retained at the establishment for
no less than 1 year, and for an additional 2 years at the establishment
or other location from which the records can be made available to
Program employees.
Sec. 381.607 Enforcement.
(a) Implementation. (1) The following establishments shall meet the
requirements of this subpart by the date prescribed:
(i) Establishments that conduct the following categories of
processes shall comply by [insert date 12 months after publication of
final rule]: Raw, Ground (including mechanically separated poultry);
Thermally Processed/Commercially Sterile; and All Other, Shelf Stable,
Heat Treated.
(ii) Establishments that conduct the following categories of
processes shall comply by [insert date 18 months after publication of
final rule]: Non-Shelf Stable, Heat Treated, Not Fully Cooked; and
Shelf Stable, Not Heat Treated.
(iii) Establishments that conduct the following categories of
processes shall comply by [insert date 24 months after publication of
final rule]: Fully Cooked, Non-Shelf Stable; and Non-Shelf Stable with
Secondary Inhibitors.
(iv) Establishments that have the following categories of processes
shall meet the requirements of this part by [insert date 30 months
after publication of final rule]: Raw, Other; and Slaughter, All
Poultry Kind.
(v) Small entities that generate less than $2.5 million dollars of
product per year shall comply by [insert date 36 months after
publication of final rule].
(2) Any establishment that obtains Federal inspection on or after
the effective date(s) for the process category(ies) to be conducted
shall conduct a Hazard Analysis, and shall develop and validate its
HACCP plan(s), as set forth in Sec. 381.602(d) of this subpart,
concurrent with the grant of inspection. Process analysis, as set forth
in Sec. 381.604(c), shall commence after obtaining Federal inspection
to assure compliance with the critical limits of the HACCP plan and
that the HACCP system is functioning as intended.
(3) Any establishment that institutes a new process requiring
development of a HACCP plan on or after the applicable effective
date(s) of this regulation shall conduct all activities required for
hazard analysis, development, and validation of its HACCP plan(s) for
the process category(ies), as set forth in Sec. 381.602(d) of this
subpart, before commencing production and shall conduct process
analyses, as set forth in Sec. 381.604(b), to assure compliance with
the critical limits of the HACCP plan and that the HACCP system is
functioning as intended.
(4) Commencing with the applicable effective date(s), the Program
shall refuse new inspection services requested for, or, using the
procedures in Sec. 381.237, suspend inspection services from
establishments or specific processes within establishments not having
HACCP plans.
(b) Verification. The Program shall verify that HACCP plan(s) are
effective and validated, and otherwise in compliance with this
regulation. Such verification and process validation may include:
(1) Reviewing the HACCP plan,
(2) Reviewing the CCP records,
(3) Reviewing and determining the adequacy of corrective actions
taken when a deviation occurs,
(4) Conducting verification activities to determine whether CCP's
are under control,
(5) Reviewing the critical limits,
(6) Reviewing other records pertaining to the HACCP plan or system,
(7) Random sample collection and analysis to determine the safety
of the product, and/or
(8) On-site observations and records review for revalidation of
HACCP plans.
(c) Suspension, correction of invalid plans. (1) If the Program
finds a HACCP plan to be invalid, inspection service for the process
covered by the HACCP plan will be suspended using the procedures in
Sec. 381.237. The processing facilities identified shall not be used
for production of poultry product pending completion of the specified
corrective action(s), as prescribed in paragraph (c)(3) of this
section, and written acknowledgement thereof by the designated Program
official. Product produced by that process prior to the suspension
suspected of being adulterated shall be retained at the establishment
pending disposition by the Program, and if such product has been
shipped, it shall be subject to voluntary recall as necessary to
protect public health.
(2) A HACCP plan may be found invalid if:
(i) The HACCP plan does not meet the requirements of this subpart,
(ii) HACCP records are not being maintained as required to validate
the [[Page 6850]] plan or verify process control under the plan, or
(iii) A processing failure results in production of adulterated
product.
(3) Invalid HACCP plans must be corrected by:
(i) Submission to the designated program official of a written,
detailed verification by a HACCP-trained individual that a modified
HACCP plan has been developed in consultation with that individual and
that as modified the plan corrects the deficiencies found, and
(ii) In the case of a processing deficiency resulting in production
of adulterated product, submission to the designated Program official
of and adherence to a written plan for finished product produced under
the modified HACCP plan to be tested by an external laboratory for
chemical or microbial characteristics, at the establishment's expense,
as appropriate to demonstrate that the process under the modified HACCP
plan corrects the identified problem.
(4) If the establishment fails to adhere to the modified HACCP plan
and, if applicable, the testing plan, resulting in a subsequent
suspension of the same process for the same or a related deficiency,
the designated Program official will, upon receipt and before
acknowledgement of any subsequent modified plan(s) under paragraph
(c)(3) of this section, also review the establishment's performance
under the inspection regulations generally and make a written
recommendation to the Administrator as to whether any additional
inspection or enforcement measures may be required.
(5) If the Administrator finds deliberate falsification of HACCP
records, the Administrator will issue a complaint for withdrawal of
inspection services from the establishment and will refer the case to
the Department of Justice for criminal prosecution.
Done at Washington, DC, on January 25, 1995.
Michael R. Taylor,
Acting Under Secretary for Food Safety.
Note: The following Appendix will not appear in the Code of
Federal Regulations.
Appendix--Generic HACCP for Raw Beef
National Advisory Committee on Microbiological Criteria for Foods
Adopted June 17, 1993
Table of Contents
I. Introduction
II. Epidemiology of Foodborne Illness Associated with Raw Beef
III. Microbiological Profile of Raw Beef
IV. Hazard Analysis
V. Generic HACCP
A. Farm Management Practices
B. Slaughter Operations
C. Distribution, Retailing, and Preparation
VI. Role of Regulators and Industry in HACCP-based Beef Processing
VII. New Technologies and Procedures
VIII. Research Needs
IX. Attachments
A. General Sanitation Guidelines for Raw Beef Slaughter and
Fabrication Operations.
B. General Guidelines for the Handling of Raw Beef Products in
Retail Food Stores and Food Service Establishments.
C. General Guidelines for the Handling of Raw Beef Products by
Consumers.
D. Control Points and Critical Control Points for Beef Slaughter
and Fabrication Operations.
I. Introduction
The following generic Hazard Analysis Critical Control Point
(HACCP) plan for beef slaughter and processing focuses on the slaughter
and processing portions of the total ``farm to consumption'' scope of a
complete HACCP program. The Committee realizes that animal production
practices can play a significant role in controlling microorganisms of
food safety concern. An overview of key attributes of live animal
management that significantly impact introduction or control of
foodborne pathogens in relation to the ultimate microbiological safety
of raw beef products is included in Section V.A. Likewise, specific
practices and procedures are required to ensure the microbiological
integrity of beef products while they are in distribution networks and
during retailing. Improper handling of products during processing,
distribution, in food service establishments or in the home, can result
in the introduction, survival, or growth of pathogenic microorganisms.
A lack of adequate controls throughout the complex food chain will
increase the risk of foodborne disease. This portion of the total HACCP
program is introduced in Section V.C, and will be additionally
discussed in a more general document that will be developed to identify
critical factors that must be controlled to ensure the safe
distribution and marketing of meat and poultry products.
The generic HACCP plan reviews the processing steps of slaughter
operations. The goal of HACCP for slaughter operations is to prevent,
eliminate, or reduce both the incidence and levels of microorganisms
pathogenic for humans. While beef slaughter operations do not include a
lethal treatment (e.g., thermal process) that ensures elimination of
pathogenic microorganisms, a number of the processing steps can be
controlled to minimize microbiological hazards. The overall objective
of the HACCP program is to ensure that processing is conducted in a
manner that enhances the microbiological safety of the product. This is
achieved through the effective management of key operations that can be
used to realistically prevent or control the introduction or growth of
pathogens.
Integral to HACCP systems is adherence to the general practices
common to all well controlled food production facilities such as
adequate sanitation, good manufacturing practices (GMPs), effective
equipment/facility design, and maintenance (ICMSF, 1988; Druce, 1988).
A knowledgeable, well trained workforce is essential in carrying out
these practices. Important GMPs related to beef slaughter operations
are outlined in ATTACHMENT A.
Several new technologies for beef slaughtering are in various
stages of development, testing, and implementation. New technologies
that are likely to become operational in the near future are included
in the generic HACCP plan. A summary that discusses each of the new
technologies and the anticipated benefits of implementation is included
(Section VII). Areas where additional research is required are also
discussed (Section VIII). Academic, government, and industry
researchers should be encouraged to address these and related areas
that provide new knowledge and technologies for enhancing the
microbiological safety of beef products.
The generic plan provides general guidance for developing plant-
specific plans. Such individualized HACCP plans for specific products
and facilities should be developed and implemented by manufacturers as
the optimal means for food safety management (NACMCF, 1992). HACCP is
also recommended for use as a tool for inspection operations. The food
processor has the responsibility for developing and implementing well-
defined HACCP plans. The role of the regulatory agency is to verify
that the processor's HACCP plans are effective and being followed. The
USDA inspector should use the HACCP plan for monitoring and conducting
verification as necessary. A discussion of the role of regulatory
agencies and industry is included in Section VI.
In addition, a generic document which outlines the specific roles
of the regulatory agencies and industry in HACCP has been prepared by a
separate Working Group of the Committee.
The Committee recommends the adoption of HACCP principles to reduce
[[Page 6851]] the risk of contamination by pathogenic microorganisms.
In accordance with the NACMCF focus on safety (NACMCF, 1992), the
current plan specifically addresses microbiological safety. However, it
is worth noting that the increased process/product control achieved
through the adoption of HACCP is also likely to enhance the
microbiological quality of raw beef products. Full implementation is
critical for HACCP plans to be successful. Management's commitment to
the HACCP concept is imperative for successful implementation. The
Committee recommends that HACCP plans include consideration of specific
mechanisms for facilitating communication among all levels of plant
operations and management.
References
1. Druce, E. 1988. Ensuring the compliance of food manufacture with
the design of the food. Food Sci. Technol. Today 2(1):58-59.
2. ICMSF (International Commission on Microbiological Specification
for Foods). 1988 ``Microorganisms in Foods 4. Application of the
Hazard Analysis Critical Control Point (HACCP) System to Ensure
Microbiological Safety and Quality.'' Blackwell Scientific Pub.
London.
3. NACMCF (National Advisory Committee on Microbiological Criteria
for Foods). 1992. Hazard analysis and critical control point system.
Int. J. Food Microbiol. 16:1-23.
II. Epidemiology of Foodborne Illness Associated With Raw Beef
A. Introduction
Foodborne disease is an important cause of morbidity in the United
States and throughout the world (Archer and Kvenberg, 1985; Cliver,
1987). Surveillance of foodborne diseases and prospective studies have
identified foods of animal origin as important vehicles for
microorganisms causing human illness (Todd, 1983, 1989; Bean and
Griffin, 1990). The live animal is exposed to a variety of potential
sources of microorganisms (e.g., soil, water, feeds, air, other
animals, etc.), and often acquires pathogenic microorganisms initially
as a result of exposure ``on the farm'' or during transport (Galton, et
al., 1954; Ayers, 1955; Linton, et al., 1974; Martin and Smith, 1984;
Clegg, et al., 1986; Grau, 1987; Linton and Hinton, 1987). In healthy
animals, microorganisms are confined primarily to the gastrointestinal
tract and exterior surfaces (hooves, hide, hair). During slaughtering
and dressing, the surface of the carcass and subsequent cuts of meat
may become contaminated with these microorganisms (Ayers, 1955; Mackey
and Derrick, 1979; Smeltzer, 1984; Chandran, et al., 1986; Grau, 1987;
Dixon, et al. 1991). Foods of animal origin may also be contaminated by
microorganisms persisting in the processing environment, or as a result
of contact with food handling personnel or equipment during processing,
distribution, retailing, and use (Empey and Scott, 1939; Ingram, 1949;
DeWit and Kampelmacher, 1981, 1982; Smeltzer, 1984; Smulders and
Woolthuis, 1983; Druce, 1988; Ligugnana and Fung, 1990; Restaino and
Wind, 1990). The extent of this contamination will depend, to a large
degree, on the sanitary control exerted during slaughtering and
dressing (Ayers, 1955; Empey and Scott, 1949; Ingram, 1949; Smulders
and Woolthuis, 1983; Chandran, et al., 1986; Dixon, et al., 1991). This
section focuses on the microorganisms that are the primary cause of
morbidity and mortality associated with raw beef products.
B. Sources and Limitations of Data
In the United States, foodborne disease data are derived from
outbreak investigations, prospective studies, and outbreak and sporadic
disease surveillance conducted and reported by public health
organizations such as the U.S. Centers for Disease Control and
Prevention (CDC). The majority of the data is acquired through passive
outbreak surveillance programs. It is assumed that the incidence data
represent only a fraction of the total number of cases due to
significant under reporting (Bean and Griffin, 1990; Buchanan and
DeRoever, 1993). Such programs do not effectively record the incidence
of sporadic disease. Assessing the impact of raw beef products on
foodborne disease is complicated by the potential for such foods to
serve as an indirect source of pathogens. Further, most available
outbreak data are for cooked beef products. Identification of any
relationship between an outbreak and the presence of pathogenic
microorganisms in raw beef must be determined through adequate
investigations that pinpoint food handling, processing, and preparation
errors. Typically, microbial foodborne disease outbreaks involve errors
associated with mishandling or inadequate processing of the raw beef,
failure to control time and temperature after cooking, or post-
processing contamination.
C. Outbreak Data
In the United States between 1973 and 1987, beef products accounted
for 9% of reported outbreaks and 10% of the cases in which a food
vehicle was implicated (Bean and Griffin, 1990). Similar results were
reported for Canada (Todd, 1989). Raw beef has been reported to serve
as a vehicle for a variety of disease causing organisms (i.e., viruses,
protozoa, parasites, etc.); however, bacterial pathogens accounted for
92% (159 of 172) of beef-associated outbreaks in which an etiologic
agent was identified (Bean and Griffin, 1990). The primary bacterial
etiologic agents for beef-related outbreaks were Salmonella spp. (48%),
Clostridium perfringens (32%), and Staphylococcus aureuas (14%).
Recently, Escherichia coli 0157:H7 has played an increasingly important
role as a cause of raw beef associated foodborne illness. Contamination
of the raw beef combined with improper food handling practices is an
important factor in a substantial portion of the Salmonella cases
(Silliker, 1982; Bryan, 1979). Clostridium perfringens outbreaks are
generally associated with cooked products that are held at inadequate
holding temperatures in institutional and food service settings (Bryan,
1980). Spices and other dry ingredients can also be a source of C.
perfringens, enterotoxigenic Bacillus cereus, S. aureus, and Salmonella
(NRC, 1985). Food handling personnel are the primary source of S.
aureus, and outbreaks are generally associated with temperature abuse
after contamination of the cooked products (Bryan, 1980).
D. Sporadic Cases
Foodborne diseases that are predominately associated with sporadic
cases are under-represented by outbreak data. A pertinent recent
example associated with beef is E. coli 0157:H7, a major agent of
hemorrhagic colitis (Belongia, et al., 1991; Doyle, 1991; Griffin, et
al., 1988; Riley, 1987; Wells, et al., 1991). A prospective study of
diarrheal disease in the State of Washington identified this organism
as the third most frequently isolated cause of bacterial diarrheal
disease (MacDonald, et al., 1988). Of particular concern is this
organism's association with hemolytic uremic syndrome (HUS), a sequela
of hemorrhagic colitis. This life-threatening, chronic kidney disease
occurs in 2-7% of patients with shiga-like toxin E. coli-associated
disease (Griffin and Tauxe, 1991). HUS has a 6% rate of mortality, with
children being the most susceptible.
Listeria monocytogenes is another pathogen where a substantial
portion of the cases caused by this microorganism are sporadic. While
foodborne transmission appears to account for most human listeriosis
cases, no epidemiological link to beef products [[Page 6852]] has been
established (Schuchat, et al., 1991, 1992; Farber and Peterkin, 1991;
Ryser and Marth, 1991).
E. Mechanisms of Transmission and Risk Factors
Since beef products may be eaten after cooking procedures that are
insufficient to assure elimination of bacterial pathogens, intrinsic
contamination of the raw product represents a potential risk. This is
particularly true for ground beef where contamination that would
normally be limited to the exterior of meat is spread throughout the
product during grinding (ICMSF, 1980). This problem has also occurred
when roast beef that was internally contaminated by restructuring or
injection was inadequately cooked (Bryan and McKinley, 1979).
Food handling errors often contribute to foodborne disease
outbreaks (Todd, 1983, 1989). These include such factors as improper
holding temperatures, inadequate cooking, contaminated equipment, and
food handler hygiene. Inadequate cooking and improper holding
temperatures are particularly pertinent for beef products. A number of
these factors have been addressed successfully. For example,
undercooking in commercial plants has been addressed through the
standardization of thermal processing requirements, such as the
guidelines for roast beef (USDA, 1983 NACMCF, 1989). However, similar
levels of control have not been achieved in the home or in all food
service establishments.
Other factors that appear to influence the incidence of foodborne
disease are the source, primary purpose, and health of the animals. At
least for E. coli 0157:H7, there is a strong correlation with meat from
dairy cattle, but not ``fed'' cattle (Wells, et al., 1991; Doyle, 1991;
Griffin and Tauxe, 1991). The incidence was highest in young animals.
Higher incidences of Salmonella contamination of raw beef products also
appears to be correlated with calf slaughter operations (Hogue, et al.,
1993).
The beef industry is made up of two major segments. Animals for the
fed-cattle market come through feedlots to the slaughter plants. These
are largely animals raised for higher quality meat, and are processed
into wholesale cuts for boxed beef. The trimmings go into manufacturing
ground beef or sausage. The majority of fed-cattle are slaughtered by a
small number of large operators. Cow meat is produced from culled dairy
cattle or beef cows advanced in age. The primary use of cow meat is
ground beef and processed meats. This segment of the industry is
characterized by a large number of small operators. A recent survey of
the beef slaughter industry indicated that the overall microbiological
quality of raw beef was inversely correlated to slaughter volume;
however, no such association was observed for Salmonella contamination
(Hogue, et al., 1993). Salmonella contamination was more closely
related to the health of animals brought to slaughter. It is important
to note that surveys of this type only provide broad statistical
trends. Further work is needed to determine the operational differences
both within and between large and small volume operations that could
account for the observed trends.
References
1. Archer, D.L. and Kvenberg, J.E. 1985. Incidence and cost of
foodborne diarrheal disease in the United States. J. Food Protection
48:887-894.
2. Ayers, J.C. 1955. Microbiological implications in the handling,
slaughtering, and dressing of meat animals. Adv. Food Res. 6:109-
161.
3. Bean, N.H. and Griffin, P.M. 1990. Foodborne disease outbreaks in
the United States, 1973-1987: Pathogens, vehicles, and trends. J.
Food Protection 53:804-817.
4. Belongia, E.A., MacDonald, K.L., Parham, G.L., White, K.E.,
Korlath, J.A., Lobato, M.N., Strand, S.M., Casale, K.A., and
Osterholm, M.T. 1991. An outbreak of Escherichia coli 0157:H7
colitis associated with consumption of precooked meat patties. J.
Infec. Dis. 164:338-343.
5. Bryan, F.L. 1979. Prevention of foodborne diseases in food
service establishments. J. Environ. Health 41:198-206. Bryan, F.L.
1980. Foodborne diseases in the United States associated with meat
and poultry. J. Food Protection 43:140-150.
6. Bryan, F.L. and T.W. McKinley. 1979. Hazard analysis and control
of roast beef preparation in foodservice establishments. J. Food
Protection 42:4-18.
7. Buchanan, R.L. and DeRoever, C.M. 1993. Limits in assessing
microbiological food safety. J. Food Protection (In Press).
8. Chandran, S.K., J.W. Savell, D.B. Griffin, and C. Vanderzant.
1986. Effect of slaughter, dressing, fabrication, and storage
conditions on the microbiological and sensory characteristics of
vacuum packaged beef steaks. J. Food Sci. 51:37-39.
9. Clegg, F.G., Wray, C. Duncan, A.L., and Appleyard, W.T. 1986.
Salmonellosis in two dairy herds associated with a sewage farm and
water reclamation plant. J. Hyg. Camb. 97:237-246.
10. Cliver, D.O. 1987. Foodborne disease in the United States, 1946-
1986. Int. J. Food Microbiol. 4:269-277.
11. DeWit, J.C. and E.H. Kampelmacher. 1981. Some aspects of washing
hands in slaughter houses. Zbl. Bakt. Hyg. I Abt. Orig. B 172:390-
406.
12. DeWit, J.C. and E.H. Kampelmacher. 1982. Microbiological Aspects
of Washing Hands in Slaughterhouse. Zbl. Bakt. Hyg. I Abt. Orig. B
176:553-561.
13. Dixon, Z.R., G.R. Acuff, L.M. Lucia, C. Vanderzant, J.B. Morgan,
S.G. Mayand, and J.W. Sevell. 1991. Effect of degree of sanitation
from slaughter through fabrication on microbiological and sensory
characteristics. J. Food Protection 54:200-207.
14. Doyle, M.P. 1991. Escherichia coli 0157:H7 and its significance
in foods. Int. J. Food Microbiol. 12:289-302.
15. Empey, W.A. and W.J. Scott. 1939. Investigations on chilled
beef. Part I. Microbial contamination acquired in the meatworks.
Aust. Coun. Sci. Ind. Res. Bull. No. 126.
16. Farber, J.M. and Peterkin, P.I. 1991. Listeria monocytogenes, a
food-borne pathogen. Microbiol. Rev. 55:476-511.
17. Galton, M.M., W.V.Smith, H.B. McElrath and A.B. Hardy. 1954.
Salmonella in swine, cattle and the environment of abattoirs. J.
Infect. Dis. 95:236-245.
18. Grau, F.H. 1987. Prevention of microbial contamination in the
export beef abattoir. In: F.J.M. Smulders (ed.), ``Elimination of
pathogenic organisms from meat and poultry, Proceedings of the
international symposium: Prevention of contamination, and
decontamination in the meat industry.'' Zeist, The Netherlands. June
2-4, 1986. Elsevier, New York, pp.221-233.
19. Griffin, P.M., Ostroff, S.M., Tauxe, R.V., Greene, K.D., Wells,
J.G., Lewis, J.H., and Blake, P.A. 1988. Illnesses associated with
Escherichia coli 0157:H7 infections. Ann. Intern. Med. 109:705-712.
20. Griffin, P.M. and Tauxe R.V. 1991. The epidemiology of
infections caused by Escherichia coli 0157:H7, other
enterohemorrhagic E. coli, and the associated hemolytic uremic
syndrome. Epidemiol. Rev. 13:60-98.
21. Hogue, A.T., D.W. Dreesen, S.S. Green, R.D. Ragland, W.O. James,
E.A. Bergeron, L.V. Cook, M.D. Pratt, and D.R. Martin. 1993.
Bacteria on beef briskets and ground beef: Correlation with
slaughter volume and antemortem condemnation. J. Food Protection
56:110-113.
22. ICMSF (International Commission of Microbiological
Specifications for Foods). 1980. ``Microbial Ecology of Foods, Vol
2, Food Commodities.'' Academic Press, New York. pp.367-372.
23. Ingram, M. 1949. Benjamin Ward Richardson lecture-- Science in
imported meat industry. Part III. Hygiene and storage. J. Roy.
Sanit. Inst. 69:39-47.
24. Ligugnana, R. and Y.C. Fung. 1990. Training of food and dairy
staff for microbiological air and surface hygiene. Dairy Food
Environ. Sanit. 10(3):130-135. [[Page 6853]]
25. Linton, A.H. and M.H. Hinton. 1987. Prevention of microbial
contamination of red meat in the ante mortem phase: epidemiological
aspects. In: F.J.M. Smulders (ed.), ``Elimination of pathogenic
organisms from meat and poultry, Proceedings of the international
symposium: Prevention of contamination, and decontamination in the
meat industry.'' Zeist, The Netherlands. June 2-4, 1986. Elsevier,
New York, pp.221-233.
26. Linton, A.H., K. Howe, S. Pethiyagoda, and A.D. Osborne. 1974.
Epidemiology of Salmonella infection in calves (1): its relation to
their husbandry and management. Vet. Rec. 94:581-585.
27. Mackey, B.M. and C.M. Derrick. 1979. Contamination of deep
tissues by bacteria present on the slaughter instruments or in the
cut. J. Appl. Bacteriol. 46:355-366.
28. MacDonald, K.L., O'Leary, M.J., Cohen, M.L., et al. 1988.
Escherichia coli 0157:H7, an emerging gastrointestinal pathogen. J.
Amer. Med. Assoc. 259:3567-3570.
29. Martin, P.A.J. and Smith B.P. 1984. Control of salmonellosis in
dairy calves. In Snoyenbos, G.H. (ed), ``Proceedings of the
International Symposium on Salmonella.'' Amer. Assoc. Avian
Pathologists. University of Pennsylvania. pp.194-199.
30. NACMCF. 1989. National Advisory Committee on Microbiological
Criteria for Foods Recommendation on the Food Safety Inspection
Service Docket Number 86-041P, Processing Procedures and Cooking
Instructions for Cooked, Uncured Meat Patties. January 26, 1989.
31. NRC (National Research Council). 1985. ``An Evaluation of the
Role of Microbiological Criteria for Foods and Food Ingredients.''
National Academy Press. Washington, D.C.
32. Restaino, L. and Wind, C.E. 1990. Antimicrobial effectiveness of
hand washing for food establishments. Dairy Food Environ. Sanit.
10(3):136-141.
33. Riley, L.W. 1987. The epidemiologic, clinical, and microbiologic
features of hemorrhagic colitis. Ann. Rev. Microbiol. 41:383-407.
34. Ryser, E.T. and Marth, E.H. 1991. ``Listeria, Listeriosis, and
Food Safety.'' Marcel Dekker, Inc. New York.
35. Schuchat, A. Swaminathan, B. and Broome, C.V. 1991. Epidemiology
of human listeriosis. Clin. Microbiol. Rev. 4:169-183.
36. Schuchat, A. Deaver, K.A., Wenger, J.D., Plikaytis, B.D.,
Mascola, L., Pinner, R.W., et al. 1992. Role of foods in sporadic
listeriosis. I. Case-control study of dietary risk factors. J. Amer.
Med. Assoc. 267:2041-2045.
37. Silliker, J.H. 1982. The Salmonella problem: Current status and
future direction. J. Food Protection 45:661-666.
38. Smeltzer, T.I. 1984. Salmonella contamination of beef in the
abattoir environment. In Snoyenbos, G.H. (ed), ``Proceedings of the
International Symposium on Salmonella.'' Amer. Assoc. Avian
Pathologists. University of Pennsylvania. pp.262-274.
39. Smulders, F.J.M. and C.H.J. Woolthuis. 1983. Influence of two
levels of hygiene on the microbiological condition of veal as a
product of slaughtering/processing sequences. J. Food Protection
46:1032-1035.
40. Todd, E.C.D. 1983. Foodborne Disease in Canada--A 5-year
summary. J. Food Protection 46:650-657.
41. Todd, E.C.D. 1989. Food and waterborne disease in Canada-- 1983
annual summary. J. Food Protection 52:436-442.
42. USDA. 1983. USDA Regulation 9CFR318.17: Requirements for the
production of cooked beef, roast beef, and cooked corned beef. First
Issued on June 1, 1983.
43. Wells, J.G., Shipman, L.D., Greene, K.D., Sowers, E.G., Green,
J.H., Cameron, D.N., Downes, F.P., Martin, M.L., Griffin, P.M.,
Ostroff, S.M., Potter, M.E., Tauxe, R.V., and Wachsmuth, I.K. 1991.
Isolation of Escherichia coli Serotype 0157:H7 and other shiga-like-
toxin-producing E. coli from dairy cattle. J. Clin. Microbiol.
29:985-989.
III. Microbiological Profile of Raw Beef
A. General Microbiological Parameters Associated with Beef
Beef muscle is a nutrient-rich substrate that can support the
growth of a wide range of microorganisms. It is generally assumed that
the interior of intact muscle is free of microorganisms. However,
localized presence of bacteria can occur in lymph nodes or the area
adjacent to bone joints, particularly if they are inflamed.
Microorganisms are introduced into the interior of meats as a result of
the translocation of bacteria from the surface of the carcass. The
initial microflora is diverse at the time of slaughter; however,
subsequent refrigerated storage selects for a limited group of aerobic
psychrotrophic species, particularly those of the Pseudomonas-
Moraxella-Acinetobacter group (Johnston and Tompkin, 1992). The
specific genera encountered is dependent on the storage temperature,
oxygen availability, pH, and moisture content (von Holy and Holzapfel,
1988).
1. Temperature
Microbial growth in beef is strongly dependent on environmental
temperature. As storage temperatures are lowered toward freezing there
is a significant decrease in the rate of microbial growth as well as a
reduction in the diversity of the microflora.
2. Moisture Content
Fresh meat has a water activity (aw) of 0.99 which
supports the growth of a wide variety of bacteria, yeast, and molds. At
high aw values (aw >0.97), the rapid growth rates
characteristic of bacteria allow them to predominate. However, as meat
surfaces dry, the differential in growth rates becomes less important.
Below aw values of 0.94, fungal species play an increasingly
important role as the dominant type of microorganism.
3. pH
The pH of fresh beef is dependent on a number of factors including
feeding and handling practices at the time of slaughter, and range from
5.3-6.5. Under normal conditions, the pH of beef after slaughter and
chilling is 5.8. Both the rate of microbial growth and the
diversity of the microflora will be restricted at the lower end of the
pH range (Grau, 1981).
4. Oxygen Availability
Unpackaged fresh beef actually represents two microbiological
environments in relation to oxygen availability. The surface is
aerobic; an environment that permits the rapid growth of aerobic
psychrotrophs such as Pseudomonas. However, the poising capacity of
meat tissue is high, and an anaerobic environment predominates within 2
mm of the surface. This selects for anaerobes, microaerophiles, and
facultative anaerobes. Restricting oxygen availability through the use
of physical barriers can substantially alter microbial growth at the
surface of meats. Fresh beef is an actively respiring system and even a
partial restriction of oxygen permeability across a plastic wrap
results in a depletion of oxygen and an accompanying increase in carbon
dioxide. This produces a shift from aerobic species (e.g.,
pseudomonads) to microaerophiles and facultative anaerobes such as
Lactobacillus, Pediococcus, Leuconostoc, Streptococcus, Carnobacterium,
and Brochothrix. Grinding raw beef increases the surface area exposed
to oxygen, at the same time distributing any contamination present on
the surface throughout the meat. However, the increased surface area
also increases the amount of actively respiring muscle tissue, leading
to rapid oxygen depletion within packaging material that restricts
oxygen availability.
There has been speculation that vacuum packaging or modified
atmosphere packaging (VP/MAP) could lead to a situation where if a
product [[Page 6854]] was temperature abused, the normal aerobic
spoilage microflora could be suppressed, but pathogenic facultative
anaerobes would grow unabated (Genigeorgis, 1985; Hintlian and
Hotchkiss, 1986; Gill and DeLacy, 1991). At present, there is little
epidemiological or other data available indicating that there are any
problems with VP/MAP of raw beef. However, the potential must be
considered when evaluating the hazards associated with beef.
B. Potential for Foodborne Pathogens
Low levels of pathogenic bacteria can be isolated from a varying
percentage of raw beef products. A number of studies have examined raw
beef products for L. monocytogenes worldwide, with reported incidence
rates ranging from 0 to >50% (Ryser and Marth, 1991). The incidence
rates for Salmonella on raw beef are generally low (<5%); however,
higher rates have been reported (Felsenfeld, et al., 1950; Weissman and
Carpenter, 1969; Goo, et al., 1973; Nazer and Osborne, 1976; Stolle,
1981). The incidence of E. coli 0157:H7 in raw beef appears to be low,
and associated with dairy cattle (Doyle and Schoeni, 1987; Belongia, et
al., 1991; Wells, et al., 1991).
The sources of pathogenic microorganisms vary. For example, S.
aureus is generally associated with food handlers or mastitic cows.
Salmonella, E. coli, and other enteric pathogens are typically
associated with fecal material and can be commonly isolated from the
hooves and hides of cattle (Stolle, 1981). There appear to be several
means by which enteric pathogens become attached to raw beef, though
there does appear to be a preferential binding to connective tissue
(Benedict, et al., 1991). Recent research has indicated that the
preferential binding of Salmonella to connective tissue involves a
genetically encoded cell surface binding site (Sanderson, et al.,
1991). L. monocytogenes can be endemic in cattle; however, recent
European studies (Ryser and Marth, 1991) suggest that the food
processing environment can be an important source of this pathogen. The
presence of low levels of pathogenic bacteria on beef may be
unavoidable; however, care must be exercised to ensure that this level
is minimal. Further, beef products should be handled in a manner that
assures that pathogens of significance have little or no opportunity to
proliferate (Gill and DeLacy, 1991).
A variety of mesophilic foodborne pathogens are potentially capable
of growing in the microbiological environment associated with both the
surface or the interior if the meat is held above 8-10 deg.C (Mackey,
et al., 1980; Grau, 1981; Gibson and Roberts, 1986; Smith, 1987). The
microflora of raw beef may contain members that competitively inhibit
the growth of enteric pathogens such as Salmonella under certain
conditions (Gilliland and Speck, 1977; Gill and Newton, 1980). However,
a number of studies have concluded that the microflora of raw beef
cannot be relied on to prevent the growth of mesophilic pathogens in
temperature-abused beef (Mackey, et al., 1980; Smith, 1985, 1987;
Mackey and Kerridge, 1988). Further, vacuum and modified atmosphere
packaged raw beef that is temperature abused at 12 deg.C and
15 deg.C may support significant growth of Salmonella before
overt spoilage is detected (Gill and DeLacy, 1991). Initial studies on
the growth characteristics of E. coli 0157:H7 (Buchanan and Klawitter,
1992c; Glass, et al., 1992) indicate that it is likely to behave in a
manner similar to other serotypes of E. coli and Salmonella (Smith,
1985, 1987; Hughes and McDermott, 1989).
Psychrotrophic pathogenic species, including L. monocytogenes,
Yersinia enterocolitica, Aeromonas hydrophila, and some strains of
Bacillus cereus, represent a special concern because they are capable
of growth at refrigeration temperatures. While both Y. enterocolitica
and B. cereus have been epidemiologically linked to products of animal
origin, typically they are not associated with raw beef products.
Aeromonas hydrophila can be frequently isolated from refrigerated raw
beef; however, the role of this organism in disease outbreaks involving
non-immunocompromised individuals is still poorly understood (Palumbo,
et al., 1991).
While there have been no outbreaks of listeriosis attributed to raw
beef products, L. monocytogenes' growth characteristics, increased
thermal resistance compared to enteric pathogens, and incidence in raw
and cooked meat products (Ryser and Marth, 1991) has prompted
investigations of its behavior in raw beef. Listeria monocytogenes is
capable of growth in temperature-abused raw beef (Buchanan and
Klawitter, 1992a); however, there are conflicting reports concerning
the ability of the organism to grow in raw beef at 5 deg.C
(Kahn, et al., 1972; 1973: Johnson, et al., 1988a, b; Grau and
Vanderlinde, 1988; Buchanan, et al., 1989; Gill and Reichel, 1989;
Glass and Doyle, 1989; Shelef, 1989; Dickson, 1990; Buchanan and
Klawitter, 1991; Kaya and Schmidt, 1989, 1991). The observed
differences may be attributable to either the pH (Gill and Reichel,
1989; Kaya and Schmidt, 1991) or the physical form (cuts versus ground)
(Buchanan and Klawitter, 1991) of the meat. The effects of individual
microorganisms of meat microflora on the growth of L. monocytogenes
include none, inhibitory, and even stimulatory, depending on the
specific species or strain (Ingram, et al., 1990; Tran, et al., 1990;
Mattila-Sandholm and Skytta, 1991). A number of raw meat isolates of
lactic acid bacteria, particularly Carnobacterium and Lactobacillus
species, have been reported to produce bacteriocins against L.
monocytogenes (Schillinger and Lucke, 1989; Ahn and Stiles, 1990a, b;
Mortvedt and Nes, 1990; Lewus, et al., 1991; Buchanan and Klawitter,
1992a, b). While there are potential applications for controlling
foodborne pathogens through the use of a competitive microflora
(Buchanan and Klawitter, 1992b), the current state of knowledge does
not allow this to be relied on as a primary means of control. The
primary means for controlling psychrotrophic pathogen growth remains
the maintenance of storage temperatures as low as possible
(2 deg.C) and a normal low pH (<5.8).
References
1. Ahn, C. and Stiles, M.E. 1990a. Plasmid-associated bacteriocin
production by a strain of Carnobacterium piscicola from meat. Appl.
Environ. Microbiol. 56:2503-2510.
2. Ahn, C. and Stiles, M.E. 1990b. Antibacterial activity of lactic
acid bacteria isolated from vacuum-packaged meats. J. Appl.
Bacteriol. 69:302-310.
3. Belongia, E.A., MacDonald, K.L., Parham, G.L., White, K.E.,
Korlath, J.A., Lobato, M.N., Strand, S.M., Casale, K.A., and
Osterholm, M.T. 1991. An outbreak of Escherichia coli 0157:H7
colitis associated with consumption of precooked meat patties. J.
Infec. Dis. 164:338-343.
4. Benedict, R.C., Schultz, F.J., and Jones, S.B. 1991. Attachment
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5. Buchanan, R.L., Stahl, H.G., and Archer, D.L. 1987. Improved
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10. Dickson, J.S. 1990. Survival and growth of Listeria
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processing conditions. J. Food Safety 10:165-174. Doyle, M.P. and
Schoeni, J.L. 1987. Isolation of Escherichia coli 0157:H7 from
retail fresh meats and poultry. Appl. Environ. Microbiol. 53:2394-
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13. Gill, C.O. and Delacy, K.M. 1991. Growth of Escherichia coli and
Salmonella typhimurium on high-pH beef packaged under vacuum or
carbon dioxide. Int. J. Food Microbiol. 13:21-30.
14. Gill, C.O. and Reichel, M.P. 1989. Growth of the cold-tolerant
pathogens Yersinia enterocolitica, Aeromonas hydrophila, and
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15. Gilliland, S.E. and Speck, M.L. 1977. Antagonistic action of
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in associative cultures. J. Food Protection 40:820-823.
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17. Glass, K.A., Loeffelholz, J.M., Ford, J.P., and Doyle, M.P.
1992. Fate of Escherichia coli 0157:H7 as affected by pH or sodium
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18. Goo, V.Y.L., Ching, G.Q.L. and Gooch, J.M. 1973. Comparison of
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19. Grau, F.H. 1981. Role of pH, lactate and anaerobiosis in
controlling the growth of some fermentative Gram-negative bacteria
on beef. Appl. Environ. Microbiol. 42:1043-1050.
20. Grau, F.H. and Vanderlinde, P.B. 1990. Growth of Listeria
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21. Hintlian, C.B. and Hotchkiss, J.H. 1986. The safety of modified
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growth of enteropathogenic Escherichia coli in a laboratory medium.
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23. Ingram, S. C., Escude, J. M., and McCown, P. 1990. Comparative
growth rates of Listeria monocytogenes and Pseudomonas fragi on
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24. Johnson, J.L., Doyle, M.P., Cassens, R.G. and Schoeni, J.L.
1988a. Fate of Listeria monocytogenes in tissues of experimentally
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25. Johnson, J.L., Doyle, M.P. and Cassens, R.G. 1988b. Survival of
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Fleischwirtschaft 69:617-620.
28. Kaya, M. and Schmidt, U. 1991. Behavior of Listeria
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Growth of Salmonella on chilled meat. J. Hyg., Camb. 85:115-124.
33. Mackey, B.M. and Kerridge, A.L. 1988. The effect of incubation
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basis of the adhesion of Salmonella serotypes to chicken muscle
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Lactobacillus sake isolated from meat. Appl. Environ. Microbiol.
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temperature of growth of coliform organisms on meat, and the
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coliform organisms, Escherichia coli and Salmonella typhimurium, in
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slaughtering. J. Appl. Bacteriol. 50:239-245.
45. Tran, T.T., Stephenson, P. and Hitchins, A.D. 1990. The effect
of aerobic microfloral levels on the isolation of inoculated
Listeria monocytogenes strain LM82 from selected foods. J. Food
Safety 10:267-275.
46. Von Holy, A. and Holzapfel, W.H. 1988. The influence of
extrinsic factors on the microbiological spoilage pattern of ground
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Isolation of Escherichia coli serotype 0157:H7 and other shiga-like-
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29:985-989.
48. Weissmann, M.A. and Carpenter, J.A. 1969. Incidence of
salmonellae in meat and meat products. Appl. Microbiol. 7:899-902.
IV. Hazard Analysis
Epidemiological data (section II. A-E) indicate that three
microorganisms have accounted for 94% of the outbreaks in which beef
has been implicated. Raw beef has been a major source for salmonellae
in the outbreaks. Raw beef has been one of many potential sources
[[Page 6856]] for C. perfringens. Raw beef can be a source of S.
aureus. This is a concern in the manufacture of fermented and dried
meats. Raw beef is a source for sporadic cases and, occasionally,
outbreaks of illness due to E. coli 0157:H7.
The hazard analysis leads to the conclusion that raw beef can be an
important vehicle in the transmission of two important foodborne
pathogens: salmonellae and E. coli 0157:H7. These pathogens are similar
in a number of respects, such as:
a. Sensitivity to heat and cold,
b. Sensitivity to chemicals,
c. The ability to multiply asymptomatically in the bovine
intestinal tract, and
d. Potential for low infectious doses.
E. coli 0157:H7 and certain Salmonella serovars may cause secondary
infections and chronic sequelae. Also, both pathogens may cause death,
particularly with E. coli 0157:H7.
The primary microbiological hazards encountered during the beef
slaughtering process are salmonellae and E. coli 0157:H7. The following
generic HACCP plan will be directed primarily at control of these
pathogens. Efforts to improve slaughter hygiene will reduce the
presence of other pathogens (C. perfringens, S. aureus, L.
monocytogenes) on carcass meat.
V. Generic HACCP
The factors that impact the microbiological safety of raw beef
products during its ``farm to consumer'' lifetime can be subdivided
into four segments: (1) live animal practices, (2) slaughter and
processing operations, (3) distribution and retailing operations, and
(4) consumer food handling practices. Key factors associated with live
animal practices are introduced and discussed in Section V.A. The
individual steps involved in slaughter and processing operations are
detailed as a generic HACCP plan in Section V.B. The primary thrust of
the first two sections is the control of enteric bacteria, the class of
pathogenic microorganisms associated with and amenable to control
during these phases of raw beef production and processing. The factors
associated with distribution, retailing, and consumer practices that
impact the safety of raw beef products are introduced in Section V.C.
A. Farm Management Practices
Raw beef originates from several sources of cattle. These can be
classified into two major categories, fed beef and mature beef. Fed
beef typically comes from animals that have been raised to desired
market weight, usually less than two years of age. Mature beef comes
from dairy or beef animals that have been marketed after being used for
milk or calf production. Fed beef serves as the major source of whole
beef products and some ground beef products. Mature dairy and beef
animals are a primary source of ground meat and patties to consumers,
including food service establishments.
The husbandry practices under which fed beef cattle and mature
dairy and beef cattle are managed are quite different. However,
potential for microbial contamination of the final product exists in
both and they share many of the same risks. There are major aspects in
the production phase that can influence incidence, control, and
prevention of potential human pathogens in cattle.
1. Transportation
The production cycle, especially of fed beef, typically involves
time spent on two or more premises prior to movement to processing
facilities. Transportation is often necessary but contributes to an
increased incidence of contamination due to both the stress placed upon
animals and the increased risk of exposure of cattle to potential human
pathogens (Cole, et al., 1988; Hutcheson and Cole, 1986). Dairy animals
handled in a similar manner would experience similar risk.
Transport time should be such that the animals reach other
production facilities and processing establishments in an expedient
manner, with stress kept to a minimum. Transport vehicles should be
free of injurious structural defects. Vehicles should be clean at the
time animals are loaded, and cleaned and sanitized following unloading
at the slaughter facility.
2. Marketing
Marketing is accomplished through a number of outlets that
introduce varying degrees of risk. Cattle frequently are sold or moved
through either auction markets, direct selling from producer to
backgrounder or feedlot, video auctions, or collection points. Animals
from multiple sources are commonly commingled at one or more points
during production, resulting in transfer of potential pathogens between
animals.
Inspectors at slaughter plants must maintain high standards
regarding diseased and otherwise inferior animals, including continued
close communication with cattle producers to provide information to
improve quality and safety standards in slaughter animals.
3. Animal Husbandry
Numerous management practices are influenced by environmental
conditions. For example, excessive moisture conditions generally result
in higher levels of hide contamination with mud, feces, and other
extraneous matter. Management systems that minimize the impact of
adverse environmental conditions would be expected to decrease
microbial contamination. This may involve basic changes in animal
husbandry (Smith and House, 1992). Controlling exposure and
contamination is especially important immediately prior to shipment to
slaughter.
4. Role of Stress
Stressed animals have lowered disease resistance, making them more
susceptible to pathogens and at increased risk of shedding potential
human pathogens (Breazile, 1988). For example, animals which are
exposed to salmonellae can become intermittent shedders of this
organism. Various forms of stress can result in increased shedding and
clinical disease, causing increased exposure to pennates, increasing
the risk also to humans through contaminated meat.
Management systems addressing increased animal welfare and better
husbandry decrease levels of stress, and would be expected to decrease
the incidence of pathogens. For example, improvements in cattle
handling systems reduce stress-related immune suppression associated
with animal processing procedures (Grandin, 1984, 1987). A number of
other factors, such as animal density, frequency of feedlot pen use,
and commingling of sick animals, can affect stress levels and thus risk
of human pathogen exposure. Salmonella is capable of surviving
variable, prolonged periods of time in animal facilities (Rings, 1985).
5. Feed and Water Contamination
Feed and water are potential sources of microbial contamination to
cattle (Robinson, et al., 1991). Feedstuffs should be documented free
of Salmonella and other enteric pathogens (Mitchel and McChesney,
1991). This is especially critical for feeds containing rendered
byproducts. Water must be from clean, non-fecally contaminated sources.
6. Antimicrobial Use
Therapeutic and subtherapeutic use of antimicrobials has long been
a practice in the cattle industry. Recent emphasis on regulations and
resulting industry response, such as quality assurance programs, has
resulted in more [[Page 6857]] responsible use of antibiotics in
cattle. Therapeutic use of antibiotics is used to reduce effects of
clinical diseases in cattle, including potential human pathogens such
as salmonellae. Additional information is needed regarding advisability
of some currently accepted practices, especially when considering human
health risks (Rings, 1985; Kennedy and Hibbs, 1993).
7. Animal Identification
The beef and dairy industries, along with state and federal
agencies, must continue to develop adequate means to identify animals
from the initial production unit through the slaughter process.
Permanent animal identification is essential so producers can assume
further responsibility for the beef they market by being able to track
animals through the entire production, slaughter, wholesale, and retail
processes. Currently, mature animals are identified by backtags as part
of the Brucellosis eradication program. Retention of this portion of
the program is suggested until better means of identification are
implemented. Permanent identification is a critical issue for improving
the safety of raw beef at the producer level.
Projected Needs: Current and future strategies that may be useful
in decreasing the risk of microbial contamination at production levels
include assessments of the prevalence of human pathogens in cattle,
permanent identification of animals using advanced technology (USAHA,
1992; Maher 1991; Nelson, 1991), use of new and improved vaccines, use
of improved management methods in reducing microbial contamination
risk, and incorporation of biotechnological advances in cattle
production as they are proven to be beneficial in minimizing or
preventing microbial contamination.
Producers should be encouraged to carefully review production
methods and HACCP guidelines to decrease risks associated with
pathogenic microbial contamination (Smith and House, 1992). Utilization
of quality management principals is recommended since these concepts
will result in improved quality assurance and pre-harvest food safety
programs (Schmitz, 1993; FAPMC, 1992; AVMA, 1992). Implementation of
production practices suggested by these programs are critical at all
phases of cattle production regardless of unit size or type.
B. Slaughter Operations
Unit operations associated with the slaughter and dressing of beef
are summarized in Figure 1. A more detailed examination of each of the
steps is provided in ATTACHMENT D.
A CCP within a Hazard Analysis and Critical Control Point (HACCP)
program is defined as any point, step, or procedure at which control
can be applied and a food safety hazard can be prevented, eliminated,
or reduced to acceptable levels (NACMCF, 1992).
Seven specific CCP process steps have been designated in the
processing of raw beef (Figure 1 and Table 1). These include (1)
skinning, (2) post-skinning wash/bactericidal rinse, (3) evisceration,
(4) final wash/bactericidal rinse, (5) chill, (6) refrigerated storage,
and (7) labeling.
For each of these CCP steps critical limits are defined for proper
control. These CCPs must be monitored at a frequency sufficient to
ensure process control. Corrective actions to be taken when CCPs do not
meet critical limits should be specified clearly in the HACCP plan.
This should include the priorities of actions to be taken and the
individuals to be notified of the deviation. The HACCP system should be
verified according to HACCP principle #7 (NACMCF, 1992).
The seven CCPs with procedures associated with the processing step
are shown in the following outline.
Implementation and Management of HACCP Critical Control Points
CCP 1: Skinning
The hide is the first major source of microbial contamination on
fresh beef carcasses. Cattle leaving the farm, feed lot, or sales barn
for delivery to the slaughter plant, carry with them microbial
populations indicative of what occurred during the care and handling of
the live animal. Salmonella and other types of bacteria can be spread
during the skinning process through contact with hide, hands and
various pieces of equipment (Empey and Scott, 1939; Newton, et al.,
1978; Stolle, 1981; Grau, 1987). Current skinning technology does not
provide a means for destroying enteric pathogens that reside on the
hide of animals coming to slaughter. There also is no available means
to remove all soil from the hide of animals prior to slaughter;
however, preslaughter washing does have a positive effect (Empey and
Scott, 1939; Dixon, et al., 1991). Skinning, therefore, should be done
in a manner that will minimize cross-contamination from the hide to the
carcass. This contamination can be minimized by pulling the hide down
and out from the carcass as opposed to upward and away. In addition,
equipment and carcass contact surfaces must be properly cleaned and
sanitized. The operator performing the skinning process must be trained
to minimize contamination. Management must reinforce the proper
techniques through adequate supervision.
The effectiveness of the CCPs outlined in this document are based
on the concept of additive impact. Wash and bactericidal rinse steps
will significantly reduce the level of microbial contamination
resulting from the skinning or evisceration steps; however, the
efficacy of these processes are dependent on control of skinning and
evisceration. The procedures and corrective actions outlined for CCP 1
and CCP 3 minimize the level of contaminating material that must be
removed by the wash and rinse steps.
If critical limits for CCP 1 are exceeded, corrective actions must
be taken prior to the carcasses being subjected to the post-skinning
wash and bactericidal rinse. Corrections of CCP 1 deviations can be
achieved by adding additional operators to the skinning procedure,
reducing the chain speed in the skinning area, and/or conducting
carcass trimming prior to the post-skinning wash and bactericidal
rinse.
CCP 2: Post-Skinning Wash and Bactericidal Rinse
During the skinning process, newly exposed carcass surfaces can
become contaminated with dressing defects, i.e., fecal material, hide
and/or dirt, that may introduce bacterial pathogens. A post-skinning
wash and bactericidal rinse is an effective means of reducing this
contamination. Any pathologic conditions, i.e., abscesses, septic
bruises, etc., should be removed prior to CCP 2.
Maximum benefit of post-skinning wash and bactericidal rinse can be
achieved if the amount of contaminating material is minimized,
emphasizing the importance of CCP 1 (skinning). Proper skinning
procedures must be achieved for effective post-skinning wash and
bactericidal rinse.
Post-skinning wash and bactericidal rinse should occur as soon
after skinning as possible to limit irreversible attachment of
pathogens to the carcass. An in-line, post-skinning, potable water wash
at 90-100 deg.F and a pressure of 345-2070 kPa (50-300 psi) removes
much of the visible surface contamination (hair, specks) and reduces
microbial contamination to some extent (DeZuniga, et al., 1991). The
water wash should be followed immediately by a bactericidal rinse to
provide an effective reduction of surface bacteria. The bactericidal
rinse should be an approved antimicrobial agent such [[Page 6858]] as
chlorine (50 mg/L) or an organic acid (1-2% acetic, lactic, or citric
acids) at a temperature of 120-140 deg.F and a pressure of 70-275 kPa
(10-40 psi) (Prasai, et al., 1991). Monitoring of this CCP should be
conducted by continuous confirmation of concentration, temperature,
pressure, and chain speed.
Validation of CCP 2 should be accomplished by microbiological
testing of carcasses before and after CCP 2. A reasonable level of
testing should be performed at the initiation of a HACCP program to
establish baselines for total aerobic, mesophilic bacteria and/or
Enterobacteriaceae. These microbiological indices are useful indicators
of process control and overall sanitation, but are not effective as
indicators of enteric pathogens. All testing should be performed using
standard methods (Vanderzant and Splittstoesser, 1992). After
establishment of the baseline, verification of CCP 2 can be achieved by
periodic sampling of carcasses for the two microbiological indicators,
using the same methods employed in establishing the baseline. These
data should be reviewed using trend analysis and statistically
significant increases should prompt a review of CCP 2 operations.
Literature indicates a functioning wash and bactericidal rinse step in
conjunction with acceptable adherence to CCP 1 should deliver an
approximate 90% reduction in microbial levels. Specific bactericidal
agent concentrations, temperatures, and pressures to be used should be
based on appropriate available literature and in-plant testing to
obtain optimal bacterial reductions (Patterson, 1968, 1969; Kotula, et
al., 1974; Emswiler, et al., 1976; Quartey-Papafio, et al., 1980;
Osthold, et al., 1984; Woolthuis and Smulders, 1985; Acuff, et al.,
1987; Prasai, et al., 1991; and Dickson and Anderson 1992).
CCP 3: Evisceration
The intestinal tract is the second major source of enteric
pathogens during the slaughtering process. Although the animals may be
asymptomatic, they can still harbor large populations of enteric
pathogens in their intestinal tract. The bunging and evisceration
operators must be properly trained in removing the intestinal tract
intact to successfully adhere to the control parameters of CCP 3. It is
essential that the viscera not be accidentally cut and the contents
contaminate the carcass, the operator, or equipment (Empey and Scott,
1939; Mackey and Derrick, 1979; Eustace, 1981; Smeltzer and Thomas,
1981; Grau, 1987). When the intestines are accidentally cut and
contamination occurs, immediate sanitizing of equipment and knives
should be performed with 180 deg.F water, and involved personnel should
utilize hand washing and sanitizing facilities to avoid contamination
of subsequent carcasses. The most effective means of control lies in
adequate training of the operator in the correct procedures, including
providing the rationale on the importance of maintaining the viscera
intact, coupled with positive reinforcement through appropriate
supervision. Accordingly, monitoring this CCP entails periodic
observation of the evisceration operations including visual inspection
of eviscerated carcasses. This can correlate to potential carcass
contamination.
CCP 4: Carcass Final Wash
Additional microbial contamination of the carcass surface is likely
to occur as a result of evisceration, viscera handling, and carcass
splitting. An in-line, potable water wash at 90-100 deg.F and a
pressure of 345-2070 kPa (50-300 psi) will help reduce microbial
levels, including enteric pathogens (DeZuniga, et al., 1991). This
final water wash should be followed by a bactericidal rinse containing
an approved antimicrobial agent such as chlorine (50 mg/L) or an
organic acid (e.g., 1-2% acetic, lactic, or citric acids) at a
temperature of 120-140 deg.F and a pressure of 70-275 kPa (10-40 psi)
(Prasai, et al., 1991).
This combination of a final wash and bactericidal rinse will help
minimize carriage of pathogens through the remaining beef fabrication
and packaging processes. Monitoring of this CCP should be through
continuous confirmation of antimicrobial concentration, temperature,
pressure, and chain speed. Verification can be achieved by conducting
microbiological testing as described in CCP 2 to confirm that CCP 4 is
providing the anticipated level of control of microbial levels. Maximum
effectiveness of CCP 4 can only be realized if the critical limits for
CCP 1-3 are maintained. Any deviations associated with the earlier CCPs
must be corrected before the product is subjected to the final wash.
Specific bactericidal agent concentrations, temperatures, and pressures
to be used should be based on appropriate available literature and in-
plant testing to obtain optimal bacterial reductions (Patterson, 1968,
1969; Kotula, et al., 1974; Emswiler, et al., 1976; Quartey-Papafio, et
al., 1980; Osthold, et al., 1984; Snijders, et al., 1985; Woolthuis and
Smulders, 1985; Smulders, et al., 1986; Acuff, et al., 1987; Prasai, et
al., 1991; and Dickson and Anderson 1992; Siragusa and Dickson, 1992;
Dickson, 1992).
CCP 5: Chill
The bacterial flora including any enteric pathogens found on the
sides of fresh beef could multiply if the meat is not properly chilled.
Cooling rates must be sufficient to limit the growth of enteric
pathogens. Temperature guidelines would include a deep muscle (6 in.)
temperature of 45 deg.F within 36 hours, with a temperature
of 50 deg.F reached within the first 24 hours (Reuter,
1990). Overnight rapid chilling of properly spaced beef sides is a
proven system to control the multiplication of enteric pathogens (Grau,
1987; Mackey, et al., 1980). The CCP can be monitored through the
continuous confirmation of physical factors affecting cooling rates
such as environmental temperatures and air circulation rates.
Verification can be achieved through the periodic recording of deep
muscle cooling rates for selected carcasses, using appropriately
calibrated temperature recording devices (e.g. thermocouple).
CCP 6: Refrigerated Storage
After chilling, the carcasses and resulting raw products must be
maintained under adequate refrigeration during all subsequent handling
and processing until the final product is ultimately consumed. This
highly diffuse CCP requires that manufacturers, distributors,
retailers, food service operators, and consumers each take
responsibility for assuring that raw beef products are kept under
adequate refrigeration. Maintaining products in a refrigerated state
(product temperature 45 deg.F), along with appropriate
cleaning and sanitizing of equipment and food contact surfaces, will
control the multiplication or accumulation of non-psychrotrophic
pathogens. Further, maintaining storage temperatures as close to
freezing as practical will enhance control of psychrotrophic pathogens.
CCP 7: Labeling
Adequate product identification (e.g., code dates, lot
identification) is necessary for product control in the event that
product must be traced or retrieved. To facilitate the responsibilities
of distributors, retailers, food service operators and consumers, all
raw and partially cooked beef products should be labeled to indicate
that the product must be refrigerated, handled, and cooked properly to
ensure safety. Methods of cooking and sanitary handling should reflect
the needs of the specific product. Labels should be appropriate for
either retail and [[Page 6859]] institutional consumers. A universal
logo should be designed to identify raw beef products for consumers.
The logo should include space for instructional information specific
for the product. An example of a potential logo is depicted in Figure
2.
The seven CCPs are summarized in Table 1.
C. Distribution, Retailing, and Preparation
An effective HACCP plan for the production, slaughtering, and
initial processing of raw beef will greatly increase control of
pathogenic microorganisms; however, even under the best operating
conditions low numbers of pathogens may remain on the carcass. Further,
care must be exercised to prevent re-introduction of pathogens, such as
Salmonella and S. aureus, that are epidemiologically linked to beef
products.
After slaughter, dressing and processing, raw beef goes through a
complex system of distribution and marketing (including wholesalers,
distributors, retail stores and food service establishments) before
ultimately reaching the end users who consume the products. Throughout
distribution and preparation of raw meats, there is a significant
potential for product mishandling leading to the introduction of
additional pathogenic microorganisms, or the spread of any pathogens
remaining on raw beef to other foods. Improper handling and storage
practices, including improper holding temperatures, inadequate cooking,
contaminated equipment and food worker hygiene, have all contributed to
beef associated foodborne outbreaks (Bryan, 1988). The microbiological
hazards associated with raw beef can be controlled by extending HACCP
principles to product handling activities in retail stores, food
service establishments, institutional feeding facilities, and homes.
The goal of the HACCP system in food distribution and preparation
is to minimize microbial contamination, reduce the opportunities for
pathogens that may be present to multiply, assure the destruction of
pathogenic microorganisms through proper cooking procedures, and
prevent the cross-contamination of pathogens from raw to cooked foods.
HACCP properly applied to all segments of distribution and
preparation has the potential for:
1. Reducing the opportunities for pathogen growth, thereby reducing
the risk of foodborne disease;
2. Assuring the destruction of enteric and other non-spore forming
pathogens through proper cooking procedures;
3. Preventing the reintroduction of pathogens to the cooked product
and cross-contamination of other foods; and
4. Controlling the growth of spore forming pathogens (e.g., C.
perfringens) by use of proper time/temperature relations for storage,
holding, and serving.
An effective HACCP system in food distribution and preparation
depends on a general understanding of and adherence to the principles
of sanitation, good manufacturing and food preparation practices as
well as proper facility layout and equipment design and maintenance
(See Attachment A). The education and training of all personnel is
critical to the process and effectiveness of any HACCP program.
HACCP plans for handling and processing raw beef should be
developed and implemented by food retailers and food service
establishments as the optimal system for food safety assurance. In
institutional feeding operations such as hospitals, nursing homes, day
care centers, and prisons where the populations may be more vulnerable
to foodborne disease, special care must be taken in the preparation of
all foods, including raw beef products . The Committee recommends that
HACCP systems be implemented immediately by food service establishments
and institutions preparing foods for these special groups with
increased susceptibility. General guidelines for the safe handling of
raw beef in retail food stores and food service establishments are
provided in Attachment B.
Several national surveys (Weimer and Jones, 1977; Williamson, et
al., 1992) have shown that the public has a limited understanding of
the basic principles of food microbiology and safe home food handling
and preparation practices. In households, the successful use of HACCP
principles is dependent on the interest, knowledge and skills of the
food preparer. General guidelines for the safe handling of raw beef by
consumers are provided in Attachment C.
D. HACCP Records and Verification
The acquisition and maintenance of records are an integral and
critical principle of HACCP (NACMCF, 1992). Records of CCP performance
along with documentation of related verification activities and process
deviations are the primary tool by which a HACCP operation is managed
and decisions are reached concerning the efficacy of process. The
records of designated objective and subjective observations that should
be maintained must be specified in the HACCP plan and maintained at the
processing location. All records should be reviewed and integrated on a
specified, routine basis. This should include subjecting the data to
trend analysis to identify and correct problems before they result in
CCPs exceeding critical limits. It is recommended strongly that this
review be integrated, and the results communicated to both employees
and supervisory personnel. The mechanism and duration of records
maintenance is the responsibility of plant management, and should be
specified in the HACCP plan. However, any system established must take
into account the primary role that records review plays in
verifications by regulatory agencies.
Establishing procedures for verification that the HACCP system is
working correctly is an integral element in developing an effective
HACCP plan and system. The verification procedures should:
1. Verify that the critical limits for CCPs are satisfactory,
2. Ensure that the facility's HACCP plan is functioning
effectively,
3. Consist of documented revalidations, audits, or other
verification procedures to ensure the accuracy of the HACCP plan, and
4. Provide regulatory verification that the HACCP system is
functioning satisfactorily.
References
1. Acuff, G.R., Vanderzant, C., Savell, J.W., Jones, D.K., Griffin,
D.B., and Ehlers, J.G. 1987. Effect of acid decontamination of beef
subprimal cuts on the microbiological and sensory characteristics of
steaks. Meat Sci. 19:217-226.
2. AVMA. 1992. Recommendations from the AVMA workshop on the safety
of foods of animal origin. J. Amer. Vet. Med. Assoc. 201:263-266.
3. Breazile, J.E. 1988. The Physiology of Stress and Its
Relationship to Mechanisms of Disease and Therapeutics. ``The
Veterinary Clinics of North America: Food Animal Practice.'' W. B.
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4. Cole, N.A., T.H. Camp, L. D. Rowe Jr., D. G. Stevens, and D. P.
Hutcheson. 1988. Effect of Transport on Feeder Calves. Amer. J. Vet.
Res. 49:178-183.
5. DeZuniga, A.G., M.E. Anderson, R.T. Marshall and E.L. Iannotti,
1991. A model system for studying the penetration of microorganisms
into meat. J. Food Protection 54: 256-258.
6. Dickson, J.S. 1992. Acetic acid action on beef tissue surfaces
contaminated with Salmonella typhimurium. J. Food Sci. 57:297-301.
[[Page 6860]]
7. Dickson, J.S. and Anderson, M.E. 1992. Microbiological
decontamination of food animal carcasses by washing and sanitizing
systems: A review. J. Food Protection 55:133-140.
8. Empey, W.A. and Scott, W.J. 1939. Investigations on chilled beef
Part I. Microbial contamination acquired in the meatworks. Council
for Sci. and Indus. Res. Bull. No. 126, Melbourne, Australia.
9. Emswiler, B.S., Kotula, A.W. and Rough, D.K. 1976. Bactericidal
effectiveness of three chlorine sources used in beef carcass
washing. J. Animal Sci. 42:1445-1450.
10. Eustace, I.J. 1981. Control of bacterial contamination of meat
during processing. Food Technol. Aust. 33:28-32.
11. FAPMC. 1992. Implementing food animal pre-harvest food safety
internationally. ``Proceedings: Providing Safe Food for the
Consumer.'' Food Animal Production Medicine Consortium. Washington,
D.C.
12. Grandin, T. 1984. Reduce stress of handling to improve
productivity of livestock. Vet. Med. 79:827-831.
13. Grandin, T. 1987. Using cattle psychology to aid handling.
AgricPractice 8(5):32-36.
14. Grau, F.H. 1987. Prevention of microbial contamination in the
export beef abattoir. pp. 221-233. In F.J.M. Smulders (ed).
Elimination of Pathogenic Organisms from Meat and Poultry, Elsevier
Science Publishing Co., Amsterdam.
15. Hutcheson, D. P. and N. A. Cole. 1986. Management of transit-
stress syndrome in cattle: Nutritional and environmental effects. J.
Anim. Sci. 62:555-560.
16. Kennedy, G. A. and C. M. Hibbs. 1993. Salmonellosis. ``Current
Veterinary Therapy 3: Food Animal Practice.'' W.B. Saunders Co.,
Philadelphia. pp. 562-565.
17. Kotula, A.W., Lusby, W.R., Crouse, J.D. and de Vries, B. 1974.
Beef carcass washing to reduce bacterial contamination. J. Animal
Sci. 39:674-679.
18. Mackey, B.M. and Derrick, C.M. 1979. Contamination of the deep
tissues of carcasses by bacteria present on the slaughter
instruments or in the gut. J. Appl. Bacteriol. 46:355-366.
19. Mackey, B.M., Roberts, T.A., Mansfield, J. and Farkas, G. 1980.
20. Growth of Salmonella on chilled meat. J. Hyg., Camb. 85:115-124.
21. Maher, K. D. 1991. Implantable electronic identification, an
update of global field trials and its application in animal disease
control and eradication programs. ``Proceedings of the 95th Annual
Meeting of the U. S. Animal Health Association.'' San Diego, CA. pp.
283-286.
22. Mitchell, G. A. and McChesney, D. G. 1991. A plan for Salmonella
control in animal feeds. ``Proceedings of Symposium on the Diagnosis
and Control of Salmonella.'' San Diego, CA. U.S. Anim. Health Assoc.
pp. 28-31.
23. NACMCF (National Advisory Committee on Microbiological Criteria
for Foods). 1992. Hazard analysis and critical control point system.
Int. J. Food Microbiol. 16:1-23.
24. Nelson, R. E. 1991. Progress toward implementation of electronic
identification in the dairy industry. ``Proceedings of the 95th
Annual Meeting of the U. S. Animal Health Association.'' San Diego,
CA. pp. 289-293.
25. Newton, K.G. and Harrison, J.C.L. and Wauters, A.M. 1978.
Sources of psychrotrophic bacteria on meat at the abattoir. J. Appl.
Bacteriol. 45:75-82.
26. Osthold, W., Shin, H.-K., Dresel, J. and Leistner, L. 1984.
Improving the storage life of carcasses by treating their surfaces
with an acid spray. Fleischwirtsch 64:828-830.
27. Patterson, J.T. 1968. Hygiene in meat processing plants--3.
Methods of reducing carcass contamination. Rec. Agric. Res.,
Ministry of Agriculture, N. Ireland 17:7-12.
28. Patterson, J.T. 1969. Hygiene in meat processing plants--4. Hot
water washing of carcasses. Rec. Agric. Res., Ministry of
Agriculture, N. Ireland 18:85-87.
29. Prasai, R.K., Acuff, G.R., Lucia, L.M., Hale, D.S., Savell, J.W.
and Morgan, J.B. 1991. Microbiological effects of acid
decontamination of beef carcasses at various locations in
processing. J. Food Protection 54:868-872.
30. Quartey-Papafio, E.A., Marshall, R.T. and Anderson, M.E. 1980.
Short-chain fatty acids as sanitizer for beef. J. Food Protection
43:168-171.
31. Reuter, G. 1990. ``Hygiene and Technology in Red Meat
Production.'' In: The Scientific Basis for Harmonizing Trade in Read
Meat (J. Hannan and J.D. Collins, Eds.), Proceedings of Roundtable
Conference of the World Association of Veterinary Food Hygienists,
University College Dublin. pp. 19-36.
32. Rings, D. M. 1985. Salmonellosis in calves. ``The Veterinary
Clinics of North America: Food Animal Practice.'' W. B. Saunders
Co., Philadelphia. Vol. 1, No. 3:529-539.
33. Robinson, R. A., K. E. Ferris, D. A. Miller, and S. Srinand.
1992. Descriptive Epidemiology of Salmonella Serotypes from Cattle
in the USA (1982-1991). ``XVII World Buiatrics Congress. Amer.
Assoc. of Bovine Practitioners Conference,'' St. Paul, MN. pp.15-19.
34. Schmitz, J.A. 1993. Preharvest food safety, an international
concern. J. Amer. Vet. Med. Assoc. 202:718-729.
35. Siragusa, G.R. and Dickson, J.S. 1992. Inhibition of Listeria
monocytogenes on beef tissue by application of organic acids
immobilized in a calcium alginate gel. J. Food Sci. 57:293-296.
36. Smeltzer, T. and Thomas, R. 1981. Transfer of Salmonellae to
meat and offal by knives. Austral. Vet. J. 57:433.
37. Smith, B. P. and House, J. 1992. Prospects of Salmonella Control
in Cattle. ``Proceedings, XVII World Buiatrics Congress. Amer.
Assoc. Bovine Practitioners Conf.'' St. Paul, MN. Vol 1, pp.67-73.
38. Smulders, F.J.M., Barendsen, P., van Logtestijn, J.G., Mossel,
A.A. and van der Marel, G.M. 1986. Review: Lactic acid:
considerations in favour of its acceptance as a meat decontaminant.
J. Food Technol. 21:419-436.
39. Snijders, J.M.A., van Logtestijn, J.G., Mossel, D.A.A. and
Smulders, F.J.M. 1985. Lactic acid as a decontaminant in slaughter
and processing procedures. Vet. Q. 7:277-282.
40. Stolle, A. 1981. Spreading of Salmonellas during cattle
slaughtering. J. Appl. Bacteriol. 50:239-245.
41. USAHA. 1992. Report of the Committee on Livestock
Identification. ``Proceedings of the 96th Annual Meeting of the U.S.
Animal Health Assoc.'' pp.111-113.
42. Vanderzant, C. and Splittstoesser, D. G., eds. 1992.
``Compendium of Methods for the Microbiological Examination of
Foods. 3rd ed. American Public Health Association. Washington, D.C.
43. Weimer, J. and Jones, J. 1977. Food safety: Homemakers attitudes
and practices. U.S.D.A. Report No. 360. pp.155.
44. Williamson D. M., Gravani, R. B., and Lawless, H. T. 1992.
Correlating food safety knowledge with home food preparation
practices. Food Technol 46(5):94-100.
45. Woolthuis, C.H.J. and Smulders, F.J.M. 1985. Microbial
decontamination of calf carcasses by lactic acid sprays. J. Food
Protection 48:832-837.
[[Page 6861]]
Table 1.--Generic HACCP Plan Critical Control Points for Beef Slaughter and Fabrication
--------------------------------------------------------------------------------------------------------------------------------------------------------
Monitoring procedure/
Process/step CCP Critical limits frequency Corrective action Records Verification
--------------------------------------------------------------------------------------------------------------------------------------------------------
Skinning............. CCP(1)...... 20% of Operator observes Add operators....... Random post-skinning Examination of random
carcasses with effectiveness of Reduce chain speed. carcass examination carcasses after skinning
dressing defects. skinning process for Conduct carcass log. is complete using
each carcass. Visual trimming. sampling plan sufficient
analysis should be to assure process
conducted under control.
adequate lighting Supervisory review of
per USDA records.
requirements.
Initially, conduct
microbiological analyses
for aerobic mesophiles
and/or
Enterobacteriaceae to
establish baseline data
on expected bacterial
numbers. Periodic follow-
up analyses and trend
analysis to verify
process control.
Review control charts to
confirm that sampling
frequency is sufficient
to detect 20% defect
criteria.
Post-skinning Spray CCP(2)...... Washing: Continuous monitoring Washing: adjust Post-skinning wash Supervisory review of
Wash and 1. 90-100 deg.F. of temperature, temperature or spray and records.
Bactericidal Spray. 2. 345-2070 kPa (50- pressure and pressure. bactericidal spray Periodic microbiological
300 psi). bactericidal rinse Bactericidal spray: log. analyses for aerobic
Bactericidal Spray: concentration.. adjust temperature, Log of preventative mesophiles and/or
1. Organic acid: 1- pressure or maintenance. Enterobacteriaceae
2%. 115-130 deg.F. concentration coupled with trend
2. Chlorine: 50 ppm. Examine and repair analysis to confirm
Ambient temperature. equipment as adequacy of process in
3. 70-275 kPa (10-40 needed. comparison to data
psi) collected at CCP(1).
4. Other applications Periodic testing of
per USDA-FSIS equipment to ensure it
guidelines. is operating according
to design
specifications.
Evisceration......... CCP(3)...... 0% occurrence of the Employee observes 1. Trained employee Random post- Supervisory review of
following defects contamination and immediately trims evisceration records and operations.
for a single routes contaminated defect area on carcass examination Random examination of
carcass: Fecal carcass for carcass. log. carcasses after
material, ingesta, immediate trimming. 2. Add evisceration using a
urine or abscesses. operators. sampling plan sufficient
3. Reduce chain to assure process
speed. control.
4.4. Sanitize soiled .........................
evisceration tools
with 180 deg.F
water.
5. Sanitize soiled .........................
clothing 120 deg.F
water or
appropriate
sanitizer.
[[Page 6862]]Final CCP(4)...... Washing: 1. 90-100 Continuous monitoring Washing: adjust Final wash spray and Supervisory review of
Wash Spray and deg.F. of temperature, temperature or bactericidal spray records.
Bactericidal Spray. 2. 345-2070 kPa (50- pressure and pressure. log. Periodic microbiological
300 psi). bactericidal rinse Bactericidal spray: Log of preventative assays for aerobic
Bactericidal Spray: concentration. adjust temperature, maintenance. mesophiles and/or
1. Organic acid: 1- pressure or Enterobacteriaceae to
2%. 115-130 deg.F. concentration. confirm an adequate
2. Chlorine: 50 ppm. Examine and repair reduction in bacterial
Ambient temperature. equipment as numbers compared to
3. 70-275 kPa (10-40 needed. baseline data collected
psi). at CCP(1) and CCP(3). An
4. Other applications effective organic acid
per USDA-FSIS decontamination system
guidelines. is indicated by a 90% reduction in
bacterial numbers from
CCP(1) to CCP(4).
Periodic testing of
equipment to ensure
operation in accordance
to design
specifications.
Chill................ CCP(5)...... Deep muscle (6 in.) Continual Adjust carcass Chill log........... Supervisory review of
temperature of 45 deg.F environmental Adjust chill cooler Review thermometer
within 36 hours, conditions (e.g., temperature, air calibration log and
reaching 50 deg.F after air velocity, Alert maintenance if Periodic monitoring of
the first 24 hours. humidity, etc.) that cooler unit is not cooling rates of deep
Carcasses spaced a influence cooling functioning muscle tissue through
minimum of 1-2 rates. properly. the use of temperature
inches apart. Monitor carcass Continue chilling recording devices.
spacing upon arrival carcass until
to chill coolers. internal
Conduct random temperature reaches
temperature 45 deg.F
monitoring of .
carcasses after
appropriate chill
time.
Refrigerated Storage. CCP(6)...... Product temperature Check product Adjust temperature Temperature records. Supervisor record review.
of 45 temperature. of storage facility.
deg.F). Continuous monitoring Place product on
of temperatures of hold (i.e.,
storage facility. retain),
investigate, and
take appropriate
action.
Labeling............. CCP(7)...... Instructional labels Visual checks of each Assure correct label Labeling records.... Supervisory review of
and logo. lot. and relabel if records.
Product date Inspection of product incorrect.
to ensure use of
correct
instructional label
and/or logo.
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[GRAPHIC][TIFF OMITTED]TP03FE95.004
[[Page 6865]]
[GRAPHIC][TIFF OMITTED]TP03FE95.005
BILLING CODE 3410-DM-C
VI. Role of Regulators and Industry in HACCP-based Beef Processing
The processor has primary responsibility for development and
implementation of HACCP plans for beef slaughter, fabrication,
packaging and distribution. These plans, however, must consider the
entire food system from production to consumption. The major role of
the regulatory agency(s) is to verify that the processor's HACCP system
is effective and working as intended. In general, this includes
assurance that following the HACCP plan fulfills the intended purpose
of providing a product that is safe when properly handled and prepared
for consumption.
The role of regulatory agency(s) in inspection of beef processing
operations should be based on the recommendations of the HACCP
Subcommittee on ``The Role of Regulatory Agencies and Industry in
HACCP''. The regulatory agency(s) in cooperation with industry and
other experts in HACCP shall be actively involved in promoting the
HACCP principles and their application to assure uniformity and common
understanding. Regulations and guidelines that are promulgated by the
regulatory agency(s) should be consistent with these principles.
The focus of the regulatory agency(s) should be on those activities
associated with verification of critical control points. The processor
must make HACCP records available to the regulatory agency(s). These
records would include the processor's HACCP plan, CCPs, critical
limits, monitoring, deviations, product disposition, and corrective
actions. The HACCP plan and associated processor records must be
considered proprietary information that must not be made available
outside the regulatory agency(s).
Specific verification procedures may include: Establishing
verification inspection schedules based on risk; review of the HACCP
plan; review of CCP records; review of deviations and corrective
actions; visual inspection of operations, random sampling of final
products; review of critical limits; review of the processors
verification records; review of revalidation of the HACCP plan; and
review of HACCP plan modifications. The regulatory agency(s) should
establish the manner and frequency of verification, format for
verification reports, and other activities based on the HACCP
Subcommittee recommendations (NACMCF, 1992).
Industry's responsibility is to develop, implement and maintain an
effective HACCP system. The system should be based on the NACMCF
recommendations on HACCP principles and application (NACMCF, 1992).
Each facility should develop an HACCP team and provide for proper
training in HACCP principles. It is the processor's responsibility to
provide HACCP records to the regulatory agency(s). The processor must
assure that the records are complete, accurate and up to date. Records
for review must include pertinent information for verification and
revalidation of the HACCP plan. When necessary, amendments to the HACCP
plan will be made in response to the regulatory inspection.
It is recommended that the beef processors and associated
regulatory agency(s) adopt the principles for implementation of HACCP
as outlined by the HACCP Subcommittee on the Role of Regulatory
Agencies in HACCP. These recommendations include uniformity in adopting
HACCP principles, the characteristics of a HACCP-based inspection
program, and procedures to facilitate the adoption and implementation
of HACCP.
Reference
1. NACMCF (National Advisory Committee on Microbiological Criteria
for Foods). 1992. Hazard analysis and critical control point system.
Int. J. Food Microbiol. 16:1-23.
VII. New Technologies and Procedures
New technologies and procedures for improved microbial control
during the slaughtering process fall into two activities: preventing
contamination and decontamination. Both will be considered. In addition
to microbial control, improvements in carcass identification and
product coding can be beneficial for determining the source of
microbial pathogens.
A. Reducing the Potential for Contamination
This section includes those new technologies or improvements in
existing procedures which can be used during slaughtering to reduce
contamination from current levels to lower levels. Operators of
slaughter facilities should be encouraged to [[Page 6866]] develop
procedures which reduce or control the spread of pathogens from manure,
internal organs, hair, water, etc. to the carcass or the processing
environment. Such systems might include improved methods for hide
removal; dehairing before removing the hide; washing and/or sanitizing
saws, knives or other equipment during slaughtering operations; or
other new techniques.
The trim rail, for example, should be moved to an area as far
forward in the slaughter process as possible, preferably before the
pre-evisceration wash. Such a move would facilitate preventing carcass
contamination. This trim area should also be used to trim bruises,
lesions, and grubs before spraying the carcass with water or other
approved solutions.
The method of cutting around and handling the bung (e.g. tying off,
covering, etc.) is another example. The preferred method has been
debated for a number of years. There is general agreement, although
there is little or no published data, that this step can be a
significant source of contamination to the carcass. It is recommended
that this step be reviewed and one or more methods be specified which
will minimize carcass contamination.
B. Decontamination
There are two basic approaches to decontamination. The first
approach usually consists of spraying carcasses during slaughtering
and/or chilling. These procedures can reduce but will not destroy all
the enteric pathogens. The second approach consists of irradiating
packaged meat. Irradiation doses currently approved for use with
poultry (Cross, 1992) would be sufficient to destroy the levels of
enteric pathogens that would normally be present on freshly packaged
meat.
Both approaches require that the slaughtering process be controlled
to minimize contamination. The number of enteric pathogens on the
carcasses should be as low as possible before either method of
decontamination is applied. In addition, the method of decontamination
and the organoleptic quality of the decontaminated meat must still be
acceptable to consumers.
1. Organic Acid Sprays, etc.
Research and commercial experience has demonstrated that microbial
contaminants on the surface of carcasses can be reduced through the use
of organic acid sprays, hot water, steam and various combinations of
these and other approved bactericidal materials. There may be more than
one combination of treatments at one or more steps during slaughtering
and/or chilling. The Committee encourages the development and
implementation of such bactericidal systems to reduce the number and
incidence of enteric pathogens on carcasses and fresh meat. As systems
are developed and approved, FSIS should consider requiring the use of
systems that have been proven to actively reduce enteric pathogens. The
minimum efficacy required for such systems should be a specified
reduction of Enterobacteriaceae (e.g. a 10-fold reduction) using
standardized protocols recognized by the regulatory agency with input
from other interested parties (e.g., academia, industry, USDA-ARS,
NACMCF, and professional organizations). The conditions (e.g., time,
temperature, pH, acid concentration, etc.) for effective operation of
the decontamination system should be specified in the HACCP plan of the
slaughter establishment.
In addition to its use as an in-line system for decontamination,
this technology can be applied to unique situations. For example, under
current inspection procedures for cattle, the following occurs in the
event that during evisceration a break in viscera contaminates the body
cavity:
Carcass siderailed;
Carcass trimmed by peeling out fascia in body cavity;
Exposed bone is trimmed; and
Visual reinspection.
An alternate approach to the above may be the following:
Carcass siderailed.
Decontamination of the body cavity by:
Extensive body cavity and carcass wash with potable water.
Decontamination of the body cavity by an approved procedure (e.g.,
organic acid, alkaline solution, hot water, steam, etc.)
2. Irradiation
Irradiation is an effective technology for destroying enteric
pathogens in fresh meats. The irradiation of poultry for pathogen
control has been approved in the United States and ten other countries
(e.g., France, United Kingdom, and The Netherlands) (ICGFI, 1992).
Irradiation of raw beef should, likewise, be approved. Used
appropriately, irradiation can be an effective method for assuring the
safety of raw meats, particularly raw ground beef.
C. Carcass Identification, Product Coding
Procedures should be developed so that carcasses can be identified
as to source and can be traced back to the farm. In addition, minimum
requirements for the coding of raw beef products should be developed so
that information can be obtained relative to processing
establishment(s), sources of raw materials and time of production.
References
1. Cross, H.R. 1992. Irradiation of poultry products. 9 CFR Part
381. Federal Register 57:43588-43600.
2. ICGFI. 1992. Ninth Meeting of the International Consultative
Group on Food Irradiation. Inventory of product clearances.
International Consultative Group on Food Irradiation, Joint FAO/IAEA
Division, International Atomic Energy Agency, Vienna.
VIII. Research Needs
1. Recent research has indicated that the attachment of enteric
pathogens involves a specific, genetically-controlled interaction
between the bacterial cell surface and connective tissue. Further
research is needed to confirm these observations and elucidate the
underlying biochemistry of attachment. Potentially, this information
could be used to develop enhanced methods for preventing contamination
and/or enhancing the removal of enteric pathogens from raw beef.
2. One of the long standing questions with raw meat and poultry
products has been the epidemiological significance of low numbers of
infectious bacteria such as Salmonella, Listeria, and E. coli O157:H7.
Recent biotechnological advances allow for the first time the active
tracing of such foodborne pathogens from the farm, through the
processing operations, and to ultimate isolation in a clinical setting.
An active surveillance study should be undertaken to establish
unequivocally the role of raw meat and poultry in transmission of human
enteric diseases.
This research should be designed and conducted to identify the
major points of introduction and/or dissemination of Salmonella and E.
coli O157:H7. This information is needed to perform accurate hazard
analyses and risk assessments to develop preventive measures on the
basis of sound information.
The study should be conducted in a manner that permits acquisition
of quantitative information of the levels of pathogens related to overt
disease. While the establishment of an absolute Minimum Infectious Dose
for individuals is not a reasonable [[Page 6867]] objective, there is a
need to know on a population basis the incidence of active infections
that are likely to occur as a function of levels enteric pathogens
ingested. This information is needed to make realistic, cost-effective
decisions concerning microbiological criteria. For example, if the
infection rate at 10,000 cfu/g is 90% whereas at 100 cfu/g it is 0.01%,
one could estimate risk factors versus the cost of achieving a
significant improvement in public health. Using the cited example, it
is unlikely that there would be much practical significance in
mandating a minimum level of less than 1 cfu/g if there was not further
reduction in infection rate.
3. Determine how techniques in microbial risk assessment can be
applied to the transmission of bacterial pathogens via raw beef
products. This includes quantifying the relative importance of both the
different potential sources of pathogenic bacteria and the critical
control points that control the microbiological hazards associated with
beef slaughter operations.
4. Establish baseline data for the types and extent (level) of
microbial contamination that can be expected on raw beef products
produced under good manufacturing conditions. These data will serve as
the basis for assessing the efficacy of alternate intervention
approaches. This should include an examination of large and small
volume slaughter operations for fed-cattle and dairy cattle to
determine factors that effect incidence of foodborne pathogens in these
segments of the beef industry.
These surveys should be accompanied with an evaluation of the
relationship between the results of traditional organoleptic
inspections and assessments of both the incidence and extent of
contamination with specific human pathogens. Particular emphasis should
be directed to assessing the relationship between animal health at the
time of slaughter and the overall degree of contamination of the meat.
5. Surveys of the adequacy of refrigeration in distribution
channels, retail markets, food service establishments, and the home
have indicated that there is a significant potential that raw beef
products will be temperature abused before consumption. There is a need
to establish quantitative data on the impact of transitory or marginal
temperature abuse on the growth of pathogens on raw beef products. Data
on time/temperature relationships would provide a scientific basis for
courses of action that should be followed when there is a loss of
temperature control.
6. Establish how refrigerated raw beef should be stored to maximize
microbiological safety, with particular reference to control of
psychrotrophic pathogens.
7. Identify microbiological inhibitors that could be used in raw
meat and poultry, particularly ground beef.
8. Evaluate decontamination procedures to determine if they could
be employed as an alternate means to trimming for effectively
eliminating fecal contamination from carcasses.
9. The continued development of improved methods for the
identification of foodborne pathogens in meat and poultry products
should be encouraged. This includes rapid methods that can be used both
to identify animals that harbor enteric pathogens prior to slaughter
and to periodically verify the effectiveness of HACCP operations.
Studies of improved means for sampling to decrease lower limits of
detection, enhance accuracy, and decrease number of samples required
for statistical validity should also be encouraged.
10. It is often assumed that enteric pathogens are limited to the
surface of beef carcasses. However, evidence indicates that lymph nodes
can harbor enteric pathogens (e.g., salmonellae). This suggests that
the processing procedures described in this document would be less
effective than anticipated. The relative significance of beef carcass
lymph nodes as a potential source of Salmonella and E. coli O157:H7 is
unknown. Studies should be undertaken to determine the incidence of
these pathogens in bovine lymph nodes.
Attachment A--General Sanitation Controls for Beef Slaughter and
Fabrication Operations
Successful implementation of HACCP within a beef slaughter or
fabrication facility requires the following basic plant support
programs. Good manufacturing practices (GMPs) must be stressed
throughout the facility. These practices include programs that cover
employee personal hygiene, effective sanitation, pest management,
equipment selection and maintenance, plant environmental management,
potable water sources, operational practices, and proper storage of
packaging materials and supplies. Effective adherence to GMPs requires
orientation and follow-up training for all employees.
A. Hygiene Practices
All personnel should be trained in the importance of personal
hygiene.
Hair nets, beard covers, knives, steels, lockers, aprons, smocks,
boots, etc., should be handled and maintained in a clean and sanitary
manner. Disposable personal items should be changed as required to
assure cleanliness.
Hot water sanitizing stations should be kept at 180 deg.F with
frequent changes of water. After knives are dipped they should be
sanitized by approved sanitizers for an appropriate time interval
before reuse. This may require multiple knives to allow adequate time
in the sanitizer to assure proper microbial kill.
Knives and all personal equipment should be cleaned, sanitized, and
dried prior to storage. Special attention should be given to boots and
footwear. Storage lockers should be kept clean and free of dirty
clothes, rags, etc.
Shrouds, aprons, gloves, and cotton items should be placed in a
marked plastic container after use. These items should be given a
proper wash with a chlorine rinse and dried thoroughly before being
returned to the processing plant.
B. Equipment
Acquisition of USDA approved equipment should include consideration
of ease of cleaning, sanitation, and maintenance.
All equipment should be cleaned and sanitized daily. Pre-operative
inspections should be conducted prior to start-up.
All equipment must be maintained in good repair. As materials age,
deterioration occurs and care must be taken to monitor the equipment.
Preventive maintenance helps ensure equipment works properly and
facilitates proper cleaning and sanitizing.
Plastic or metal pallets are preferable, however, if unavailable,
wooden pallets may be used provided they are kept dry and clean.
All plastic belts and other food conveyance surface should be
inspected frequently, and replaced or resurfaced as soon as there is
evidence of cracking, pitting, or other defects that would hamper
effective cleaning and sanitizing.
A major equipment concern is controlling material buildup, i.e.,
bone dust and meat particle accumulation in areas that increase in
temperature during processing. Such problems can be minimized by
regular cleaning and appropriate documentation of all actions.
C. Movement of Personnel and Equipment
Movement of personnel and equipment between areas, particularly
between slaughter and fabrication or [[Page 6868]] processing zones can
be a source of cross contamination.
Fork lifts can be a continuing source of cross-contamination.
Movement must be excluded from areas where product is exposed.
Movement of personnel between zones should be controlled and
minimized. Sinks, boot washes, and clean outer garment exchange should
be used at zone entrances, particularly if individuals are moving from
a ``dirty'' zone to a ``clean'' area (e.g., movement from abattoir to
fabrication room).
D. Packaging
A basis for selection of approved food packaging material should be
effectiveness for protecting the product and preventing contamination.
Packaging integrity must be maintained to avoid recontamination, i.e.,
proper seals, clips, covers, vacuum levels, etc. All packaging
materials and supplies should be received and stored in manner that
ensures their integrity.
E. Pest Control
An active program for control of insects, rodents, wild birds, and
other pests should be maintained, including periodic examination of
facilities for evidence of infestations.
F. Plant Environment Management
The processing environment should be maintained to meet GMP
requirements. This includes daily operative checks to ensure
compliance.
G. Water
Water for processing should be obtained from a potable source or
where permitted, recycled according to approved guidelines. Periodic
analysis of the water should be conducted to ensure that the source
meets the recognized microbiological criteria for potable water.
General Guidelines for the Handling of Raw Beef Products in Retail Food
Stores and Food Service Establishments
A. Food Receiving and Storage
Raw beef products should be received in good condition and at a
temperature of 40 deg.F or less. A visual inspection should be
conducted to assure the condition of raw beef products.
B. Refrigerated Storage
Storage temperatures of less than 40 deg.F will minimize microbial
growth of Salmonella. Proper stock rotation should be practiced and:
A first-in, first-out stock rotation system should be utilized. All
foods should be kept covered, wrapped, dated, labelled and rotated.
Older products should be used before newly received foods.
Raw products should be stored separately from cooked, ready-to-eat
products to prevent cross-contamination.
The cooler should be regularly inspected for good sanitary
conditions and maintained at the proper temperature (<40 deg.F) and
humidity. Products should be stored to assure sufficient air
circulation.
C. Food Preparation
Delicatessen employees and food service workers should be aware of
and practice good personal hygiene at all times, especially when
preparing and handling foods.
Employees should not work when ill and should wash hands
frequently, especially after handling raw foods and after using the
restroom.
Clean clothing and appropriate hair cover should be worn by all
personnel involved in food preparation.
Raw foods should be kept separate from cooked, ready-to-eat foods.
Equipment and utensils used in the preparation of raw beef products
should be properly cleaned and thoroughly sanitized before use with
other foods.
Intact cuts of beef (roasts, chops, etc.) should be cooked to a
minimum internal temperature of 140 deg.F. The temperature should be
checked with a good quality thermometer in the thickest part of the
meat.
Hamburgers and other ground or restructured beef products should be
cooked to a minimum internal temperature of 155 deg.F. At this
temperature, the meat is well done and has no pink color.
Beef products that are cooked and held for hot display should be
kept at a temperature of at least 140 deg.F.
Leftover meat products should be refrigerated immediately in
shallow containers so quick cooling can be achieved and microbial
growth can be prevented.
Reheat leftover meats and other precooked beef products to a
minimum internal temperature of 165 deg.F.
General Guidelines for the Handling of Raw Beef Products by Consumers
A. Food Purchasing
Buy perishable foods last, after all other grocery items have been
selected. Insist that grocery baggers place all raw food of animal
origin (red meat, poultry, seafood, eggs, etc.) in a separate plastic
bag for transport. Never allow raw meat to contact a package of food
that will not be cooked before consumption. Cold foods should be placed
together in a paper bag to help prevent excessive warming during
transport.
Take purchases home immediately and place items to be kept
refrigerated or frozen in proper storage as soon as possible.
B. Kitchen Appliances and Utensils
Use a thermometer to assure refrigerator temperature is 40 deg.F or
below and that freezer temperature is below 0 deg.F.
Keep refrigerator and freezer shelves clean and sanitize
periodically.
Separate raw from cooked foods in the refrigerator or freezer. Raw
foods should never be stacked on top of cooked foods.
Use an oven thermometer to verify that the oven temperature is
approximately the same as the temperature dial selector. Most oven
owner's manuals will have instructions for adjusting the temperature
selector for accuracy.
Counter tops, sinks, and cutting surfaces should be cleaned and
sanitized after contacting any raw food. Clean surfaces with hot soapy
water and rinse thoroughly. Sanitize the surface with a chlorine
solution (one cap of bleach in one gallon of cold water; a new solution
prepared weekly).
If washing utensils by hand, knives and cutting boards used with
raw meats should be washed with hot, soapy water, followed by a hot
water rinse and sanitation with a chlorine solution after each use.
Washing in a dishwasher having a hot water rinse will sufficiently
sanitize utensils (the temperature of the rinse should be at least
120 deg.F).
C. Food Preparation
Cross-contamination occurs when utensils, plates, or hands used in
preparing raw foods are not thoroughly washed and sanitized before
using with cooked foods or foods that will not be cooked (e.g.,
salads). Never use the same plate to transport raw and cooked beef
unless thoroughly washed and sanitized between uses.
Frozen products should be thawed in the refrigerator or under cold
running water.
Cook intact beef cuts (roasts, chops, etc.) to a minimum internal
temperature of 140 deg.F. Always check temperatures with a meat
thermometer at the thickest part of the meat.
Hamburgers and other ground or restructured beef products should be
cooked until the meat is well-done (no pink color, juices run clear).
The temperature at the coolest portion of the meat should reach
155 deg.F.
Cold beef should be stored and served at 40 deg.F or less.
Leftovers should be refrigerated immediately in shallow containers
to [[Page 6869]] prevent bacterial growth. Allowing a cooked food to
``cool down'' at room temperature before refrigerating may allow
bacterial growth.
Reheat leftovers and other precooked beef products to an internal
temperature of 165 deg.F.
Attachment D: Control Points and Critical Control Points for Beef Slaughter and Fabrication
Potential site of minor contamination.
Potential site of major contamination.
--------------------------------------------------------------------------------------------------------------------------------------------------------
,
Process/step , Criteria or critical Monitoring procedure/ Corrective/ Records Verification
CCP limits frequency preventive action
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cattle receiving:
Pens............. ....... Pens dry and clean... Visual check each Reclean. Remove Receiving/holding Supervisory review of
shift. standing water. log. records.
Cattle holding... ....... Holding <24 h........ Check holding records Coordinate holding Receiving/holding Supervisory review of
each shift. and slaughter speed. log. records.
Stunning:
Bleeding......... ............ Sanitize knife (180 Visual checks and Correct procedures None................ Supervisory review.
deg.F water) between water temperature and temperature.
sticks. checks each shift.
Head/shank removal:
Skinning......... CCP(1) 20% of Operator observes Add operators. Random post-skinning Examination of random
. carcasses with effectiveness of Reduce chain speed.. carcass examination carcasses after skinning
dressing defects. skinning process for Conduct carcass log. is complete using
each carcass. Visual trimming. sampling plan sufficient
analysis should be to assure process
conducted under control.
adequate lighting Supervisory review of
per USDA records.
requirements.. Initially, conduct
microbiological analyses
for aerobic mesophiles
and/or
Enterobacteriaceae to
establish baseline data
on expected bacterial
numbers. Periodic follow-
up analyses and trend
analysis to verify
process control.
Review control charts to
confirm that sampling
frequency is sufficient
to detect 20% defect
criteria.
Post-skinning CCP(2)...... Washing:
spray wash and 1. 90-100 deg.F.
bactericidal 2. 345-2070 kPa (50-
spray. 300 psi).
Bactericidal Spray:
1. Organic acid:.....
1-2%
115-130 deg.F.
2. Chlorine:
x 50 ppm............
Ambient temperature
3. 70-275 kPa (10-40
psi)................
4. Other applications
per USDA-FSIS
guidelines. Continuous monitoring
of temperature,
pressure and
bactericidal rinse
concentration....... Washing: adjust
temperature or
pressure...........
Bactericidal spray:
adjust temperature,
pressure or
concentration......
Examine and repair
equipment as needed Post-skinning wash
spray and
bactericidal spray
log................
Log of preventative
maintenance. Supervisory review of
records.
Periodic microbiological
analyses for aerobic
mesophiles and/or
Enterobacteriaceae
coupled with trend
analysis to confirm
adequacy of process in
comparison to data
collected at CCP(1).
Periodic testing of
equipment to ensure it
is operating according
to design
specifications.
[[Page 6870]]
Evisceration..... CCP(3) 0% occurrence of the Employee observes 1. Trained employee Random post- Supervisory review of
. following defects contamination and immediately trims evisceration records and operations.
for a single routes contaminated defect area on carcass examination Random examination of
carcass: Fecal carcass for carcass. log. carcasses after
material, ingesta, immediate trimming. 2. Add operators.... evisceration using a
urine or abscesses. 3. Reduce chain sampling plan sufficient
speed. to assure process
4. Sanitize soiled control.
evisceration tools
with 180 deg.F
water.
5. Sanitize soiled
clothing with 120
deg.F water or
appropriate
sanitizer
Viscera handling. .... No viscera Visual checks........ Correct defects..... None................ Supervisory review of
contamination of operations.
carcasses.
Splitting........ ....... Clean saw and Visual checks........ Reclean saw......... None................ Supervisory review of
sanitize in 180 operations.
deg.F water.
Final wash spray CCP(4)...... Washing: Continuous monitoring Washing: adjust Final wash spray and Supervisory review of
and bactericidal 1. 90-100 deg.F. of temperature, temperature or bactericidal spray records.
spray. 2. 345-2070 kPa (50- pressure and pressure. log. Periodic microbiological
300 psi). bactericidal rinse Bactericidal spray: Log of preventative assays for aerobic
Bactericidal Spray: concentration. adjust temperature, maintenance. mesophiles and/or
1. Organic acid:..... pressure or Enterobacteriaceae to
1-2%. concentration. confirm an adequate
115-130 deg.F. Examine and repair reduction in bacterial
2. Chlorine: equipment as numbers compared to
50 ppm. needed. baseline data collected
Ambient temperature at CCP(1) and CCP(3). An
3. 70-275 kPa (10-40 effective organic acid
psi). decontamination system
4. Other applications is indicated by a >90%
per USDA-FSIS reduction in bacterial
guidelines. numbers from CCP(1) to
CCP(4).
Periodic testing of
equipment to ensure
operation in accordance
to design
specifications.
[[Page 6871]]
Chill............ CCP(5)...... 1. Deep muscle (6 Continual Adjust carcass Chill log........... Supervisory review of
in.) temperature of confirmation of spacing. records.
45 deg.F environmental Adjust chill cooler Review thermometer
within 36 hours, conditions (e.g., temperature, air calibration log and
reaching 50 deg.F after air velocity, Alert maintenance if Periodic monitoring of
the first 24 hours. humidity, etc.) that cooler unit is not cooling rates of deep
2. Carcasses spaced a influence cooling functioning muscle tissue through
minimum of 1-2 rates. properly. the use of temperature
inches apart. Monitor carcass Continue chilling recording devices.
spacing upon arrival carcass until
to chill coolers. internal
Conduct random temperature reaches
temperature 45
monitoring of deg.F. Product
carcasses after should not be moved
appropriate chill to the next step in
time sufficient to processing until
maintain process temperature is
control. reached.
Fabrication (cut ....... 1. Product Checks of product Adjust room Temperature and Supervisory review of
up). temperature of 45 deg.F. Continuous monitoring Adjust speed of records.
2. Product of room temperatures. incoming product to
transported through Check speed of accommodate 1 hour
fabrication product movement fabrication room
procedures and into through fabrication. limit.
storage within 1
hour..
--------------------------------------------------------------------------------------------------------------------------------------------------------
Note: The following Supplement will not appear in the Code of
Federal Regulations.
Supplement--Preliminary Regulatory Impact Assessment for Docket No. 93-
016P, ``Pathogen Reduction; Hazard Analysis and Critical Control Point
(HACCP) Systems''
Table of Contents
I. HACCP Produces Net Benefit to Society
II. Market Failure Justifies Regulation of Pathogens To Protect
Public Health
III. Alternatives
A. Process Control Regulatory Strategy
B. Factors Considered in Evaluating a Process Control Strategy
C. Evaluation of Mandatory HACCP to Provide Process Control
D. Evaluation of Other Alternatives
IV. HACCP Benefits--Foodborne Illness
A. Incidence of Foodborne Illness in the United States
B. Costs of Foodborne Illness
C. The Relationship Between Foodborne Illness and Consumer
Knowledge and Behavior
V. Costs Associated with HACCP
A. Cost Analysis Procedures
B. Costs of the Near-term Initiatives
C. Costs of the Long-term HACCP Intervention
D. Estimated Costs Per Plant [[Page 6872]]
I. HACCP Produces Net Benefit to Society
Food Safety and Inspection Service (FSIS) is proposing, in docket
no. 93-016P, above, to require all federally inspected meat and poultry
plants to adopt a Hazard Analysis and Critical Control Points (HACCP)
processing control system for each of its processes within 3 years of
publication of the final rule. The proposed regulations also mandate
some near-term pathogen reduction interventions prior to HACCP plan
implementation. In the same document, FSIS provides advance notice of
plans to establish interim targets, guidelines, and standards to
establish public health goals for pathogens.
The objective of these regulations is to initially reduce and
eventually minimize the risk of foodborne illness from four human
pathogens in meat and poultry in the manufacturing sector under current
production technologies. These pathogens are:
1. Campylobacter jejuni/coli;
2. Escherichia coli 0157:H7;
3. Listeria monocytogenes; and
4. Salmonella.
These regulations also require appropriate controls to minimize or
prevent other biological, chemical and physical safety hazards. To a
certain extent HACCP can improve quality aspects of products and
production efficiency. However, the benefits assessed here are based
only upon pathogen reduction and control for safety.
FSIS has selected mandatory HACCP as the centerpiece for this new
regulatory program because scientists and industry leaders agree that
it provides the most effective food processing controls available to
reduce and control meat and poultry pathogens and accomplish other food
safety objectives such as chemical residue control.
The function of this regulatory impact assessment is to evaluate
the costs and benefits of a mandatory HACCP-based regulatory program
for all meat and poultry establishments under inspection. The HACCP
``program'' includes all the interventions in this proposal. Because
contamination can occur any place in the production process, no one
intervention can minimize the risk; indeed, the value of the HACCP
system is that it provides a framework for systematically using
interventions to minimize risk. For this reason benefits have been
estimated only for the entire HACCP program. Costs are provided for
each individual intervention. (A Supplement on Costs is available from
Diane Moore, Docket Clerk, Room 3171, South Building, Food Safety and
Inspection Service, U.S. Department of Agriculture, Washington, DC
20250.)
Because there are no scientific data that can be used to relate
intermediate pathogen reductions to reductions in foodborne illness,
benefits have been based on the Agency's intention to minimize the risk
of foodborne illness in the manufacturing sector. Risk minimization
means the elimination of almost all the foodborne illness caused by the
contamination of meat and poultry products with the four pathogens
listed above in inspected plants. The amount of reduction in pathogens
needed to do this is unknown and would vary for individual pathogens
and products. The testing requirement will enable the Agency to learn
more about what pathogen reduction standards would be appropriate to
minimize risk.
The conclusion of the cost-benefit analysis is that mandating
HACCP-based processing control systems will result in net benefits that
far exceed implementation and operation costs. Table 1 provides a
summary of these costs and benefits. The proposed regulation will
redistribute costs in a fashion more acceptable to societal values
which have always given priority to minimizing the occurrence of
controllable diseases.
Table 1.--Cost-Benefit Comparison HACCP/Pathogen Reduction Proposal
(Millions of $--discounted 20 years)*
----------------------------------------------------------------------------------------------------------------
Costs Benefits**
----------------------------------------------------------------------------------------------------------------
Total................................... $2,298.9 Total.................................. $6,422-23,935
Near-Term: Foodborne illness avoided:.............
Micro testing....................... 131.9 Campylobacter jejuni/coli.............. 2,919-4,670
Sanitation SOP...................... 86.6 E. coli 0157:H7........................ 1,168-2,419
Time/Temperature Requirements....... 45.5 Listeria monocytogenes................. 584-1,168
Antimicrobial Treatments............ 51.7 Salmonella............................. 1,751-15,178
-------------
Subtotal........................ 315.7
HACCP Implementation:
Plan development.................... 35.7
Micro testing....................... 1,262.5
Record keeping...................... 456.4
HACCP Training...................... 24.2
Aseptic Training.................... 1.9
Fed. TQC Overtime................... 20.9
Agency Training..................... 0.4
SOP under HACCP..................... 181.2
-------------
Subtotal........................ 1,983.2
----------------------------------------------------------------------------------------------------------------
Source: Economic Research Service, Centers for Disease Control and Prevention, and Food Safety and Inspection
Service.
*These costs have been discounted using the OMB suggested rate of 7%.
**Benefits from elimination of Salmonella, E. coli 0157:H7, Campylobacter jejuni/coli and Listeria monocytogenes
are estimated at 90% of the total meat- and poultry-related medical costs and productivity losses associated
with each pathogen as depicted in Table 4. Total benefits start 5 years after publication of final rule.
It is not known exactly what percentage of contamination takes
place in the manufacturing sector in contrast to that which occurs
afterwards during distribution and preparation. It is clear that most
contamination takes place during manufacturing since it derives from
processing animals and cross contamination during further processing.
Agency microbiologists have estimated that about 90 percent of pathogen
contamination occurs within [[Page 6873]] the manufacturing sector, and
accordingly, only 90 percent of the benefits from the reduction of
foodborne illness costs have been included as benefits in the analysis.
FSIS expects it to take about five years from the publication of
the final rule for the proposed interventions and HACCP to reach the
risk minimization goal. By that time, all establishments will have
implemented effective pathogen reduction interventions and will have
been systematically controlling their processes for from 2 to 4 years.
Although there is reason to believe that during the first five years,
significant benefits will be generated by the interventions and
controls in place, there are no data to estimate these benefits.
Sensitivity Analysis for Table 1
The calculation of benefits in table 1 assumes benefits are zero
for years 1 to 4 and the maximum possible (i.e., 100 percent of the 90
percent attributable to contamination in the inspected plants) for
years 5 to 20. Given achievement of the estimated benefits in years 5
through 20, actual benefits to society would likely exceed these
benefit estimates for several reasons. These reasons include the
conservative valuation of a human life, no consideration of consumers'
willingness to pay for avoidance of illness, and the assumption of zero
benefits from near-term interventions and early implementation of
HACCP. The achievement of maximum benefits is also subject to
uncertainty.
In order to account for the possibility of positive benefits in
years 1 through 4 and the uncertainty of benefits in years 5 through
20, an analysis was performed to examine the sensitivity of the cost-
benefit analysis to changes in the estimated stream of benefits. The
results of this analysis are presented in table 1A, and a discussion of
the assumptions used in this analysis follows.
First, the assumption of zero benefits until year 5 is replaced by
the assumption that benefits grow linearly starting from zero and reach
the undiscounted maximum of $0.99-$3.7 billion in year 5. Thus, the low
and high end estimates of undiscounted benefits in the first year are
$0.198-$0.74 billion. Benefits increase in year 2 to $0.396-$1.48
billion and increase at the same rate until year 5. The discounted
value of benefits for years 1 to 4 is $1.733 to $6.478 billion. The
discounted value of benefits over 20 years becomes $8.155-$30.413
billion.
Sensitivity Analysis of Alternative Benefit Levels
----------------------------------------------------------------------------------------------------------------
Added benefits, years 1- Baseline benefits\2\ Reduced benefits, years
4\1\ -------------------------- 5-20\3\
-------------------------- -------------------------
Low High Low High Low High
----------------------------------------------------------------------------------------------------------------
Year
(5) Billion dollars, discounted at
7 percent
----------------------------------------------------------------------------------------------------------------
1............................. 0.20 0.74 0 0 0 0
2............................. 0.37 1.38 0 0 0 0
3............................. 0.52 1.94 0 0 0 0
4............................. 0.65 2.41 0 0 0 0
5............................. 0.76 2.82 0 0 0 0
Sum of benefits, years 1-4........ 1.73 6.48 0 0 0 0
Sum of benefits, years 5-20....... 6.42 23.94 6.42 23.94 5.78 21.54
Total benefits, years 1-20........ 8.16 30.41 6.42 23.94 5.78 21.54
Benefit-cost ratio\4\............. 3.5 13.2 2.8 10.4 2.5 9.4
----------------------------------------------------------------------------------------------------------------
\1\Assumes benefits start at 0 and increase linearly to base level benefits in year 5.
\2\Base level of benefits are those presented in table 1.
\3\Assumes 90 percent of base level of benefits.
\4\Assumes costs presented in table 1.
Alternative assumptions regarding the size of benefits are
possible. The linear assumption is arbitrary; the purpose is to
demonstrate that any benefits in years 1 to 4 will increase the 20-year
total discounted value of benefits.
Second, the assumption of zero benefits until year 5 is retained
but the realized benefit in year 5 and later is reduced by 10 percent,
making the annual undiscounted benefits $0.89-$3.32 billion. The
discounted value of benefits over 20 years becomes $5.780-$21.542
billion. The uncertainty involved in estimating the annual cost of
foodborne illness is already accounted for in the range reported in
table 4. The 10 percent reduction is an arbitrary assumption to
demonstrate the sensitivity of the cost-benefit analysis.
In neither case are costs affected. All estimates of discounted
benefits are far larger than the discounted costs for each set of
assumptions. The benefit-cost ratio ranges from 2.5:1 to 13.2:1.
Costs
Costs to meat and poultry processors across the Nation will vary
according to how much improvement in process control each plant needs.
Plants that now have good processing controls will have relatively few
implementation costs, while plants that have little or no process
control will need to spend more for implementation. A detailed analysis
of industry's costs to develop, implement, and operate HACCP systems
appears in Section V.
Costs to the Government would be for training FSIS employees.
Existing resources would be used. No additional funding is anticipated.
Program Goals
The quantifiable benefits to society from the proposed regulation
range from $6.4 to $23.9 billion as 20 years of foodborne illness and
attendant costs to society are avoided. (The wide range of benefits is
attributable to uncertainties in the data used to estimate the
incidence of foodborne illness.)
The predictability of foodborne illness reductions from a reduction
of pathogens in meat and poultry is made difficult by the fact that
little quantitative data on the relationship between these two
variables exists because many of the risk assessments necessary to
establish this relationship have not been undertaken. Therefore, it is
not known how much pathogens need to be reduced to minimize the risk of
foodborne disease from meat and poultry. One component of the proposal
is the testing of product to generate data on pathogen incidence which
will help to elucidate the relationship between pathogen contamination
and foodborne [[Page 6874]] disease, and the Agency also intends to
undertake additional risk assessments to generate dose/response curves
for specific pathogens. The Agency will use the new information from
this research to adjust targets, if necessary, to meet its goal of risk
minimization.
The Agency believes that it is reasonable to set a goal of risk
minimization assuming the implementation of the requirements in this
proposal. Current technologies can and frequently do produce product of
minimal risk. Contamination occurs from poor practices (errors) and
lack of systematic preventive controls throughout the production
process. For the first time, in this proposal the Agency is focusing on
reducing pathogens. It is mandating interventions that a large part of
the industry already uses to correct errors that cause pathogen
contamination, and it is proposing the use of a system of controls that
prevents pathogens which is the most effective way of reducing them.
Empirical evidence of how effective these interventions and HACCP
process controls are where they are currently used and the Agency's
knowledge that many establishments do not currently use them leads the
Agency to believe that the risk of pathogens in the manufacturing
sector can be minimized by the implementation and enforcement of these
requirements for all inspected establishments.
Further, the Agency is mandating product testing for pathogens
which will enable it to set targets that can establish a standard of
pathogen control throughout the industry that will minimize the risk of
foodborne illness.
II. Market Failure Justifies Regulation of Pathogens to Protect Public
Health
Consumers make choices about the food they purchase based upon
factors such as price, appearance, convenience, texture, smell, and
perceived quality. In an ideal world, people would be able to make
these decisions with full information about product attributes and
choose those foods which maximize their satisfaction. In the real
world, however, information deficits about food safety complicate
consumer buying decisions.
Since all raw meat and poultry products contain microorganisms that
may include pathogens, raw food unavoidably entails some risk of
pathogen exposure and foodborne illness to consumers. However, the
presence and level of this risk cannot be determined by a consumer,
since pathogens are not visible to the naked eye. Although they may
detect unwholesomeness from obvious indications such as unpleasant odor
or discoloration caused by spoilage microorganisms, consumers cannot
assume products are safe in the absence of spoilage. They simply have
no clear-cut way to determine whether the food they buy is safe to
handle and eat.
When foodborne illness does occur, consumers often cannot correlate
the symptoms they experience with a specific food because some
pathogens do not cause illness until several days after exposure. Thus,
food safety attributes are often not apparent to consumers either
before purchase or immediately after consumption of the food. This
information deficit also applies to wholesalers and retailers who
generally use the same sensory tests--sight and smell--to determine
whether a food is safe to sell or serve.
The societal impact of this food safety information deficit is a
lack of accountability for foodborne illnesses caused by preventable
pathogenic microorganisms. Consumers often cannot trace a transitory
illness to any particular food or even be certain it was caused by
food. Thus, food retailers and restaurateurs are generally not held
accountable by their customers for selling pathogen-contaminated
products and they, in turn, do not hold their wholesale suppliers
accountable.
This lack of marketplace accountability for foodborne illness means
that meat and poultry producers and processors have little incentive to
incur extra costs for more than minimal pathogen and other hazard
controls. The widespread lack of information about pathogen sources
means that businesses at every level from farm to final sale can market
unsafe products and not suffer legal consequences or a reduced demand
for their product. An additional complication is that raw product is
often fungible at early stages of the marketing chain. For example,
beef from several slaughterhouses may be combined in a batch of
hamburger delivered to a fast food chain. Painstaking investigation by
public health officials in cases of widespread disease often fails to
identify foodborne illness causes; in half the outbreaks the etiology
is unknown.
Most markets in industrialized economies operate without close
regulation of production processes in spite of consumers having limited
technical or scientific knowledge about goods in commerce. Branded
products and producer reputations often substitute for technical or
scientific information and result in repeat purchases. Thus brand names
and product reputations become valuable capital for producers.
In the U.S. food industry, nationally recognized brand names have
historically provided significant motivation for manufacturers to
ensure safe products. In recent years, more and more meat and poultry
have come to be marketed under brand names.
Yet in the case of meat and poultry contaminated with pathogenic
microorganisms, even brand name protection has not provided enough
motivation for processors to produce the safest product they can make.
The failure of meat and poultry industry manufacturers to produce
products with the lowest risk of pathogens and other hazards cannot be
attributed to a lack of knowledge or appropriate technologies. The
science and technology required to significantly reduce meat and
poultry pathogens and other hazards is well established, readily
available and commercially practical.
There are three main explanations for why a large portion of the
meat and poultry industry has not taken full advantage of available
science and technology to effectively control manufacturing processes.
1. Meat and poultry processing businesses are relatively easy to
enter; there are no training or certification requirements for plant
operators. Consequently, the level of scientific and technical
knowledge of management in many plants is minimal.
2. The industry is very competitive and largely composed of small
and medium-sized firms that have limited capital and small profits.
3. Management in many of these plants has little incentive to make
capital improvements for product safety because they are not
distinguishable by customers and therefore yield no income.
In spite of these barriers, many industry establishments do produce
meat or poultry products using process controls that assure the lowest
practical risk of pathogens and other hazards. But a significant part,
particularly those producing raw products for consumers for further
processing, do not.
FSIS has concluded that the lack of consumer information about meat
and poultry product safety and the absence of adequate incentives for
industry to provide more than minimal levels of processing safety
represents a market failure requiring Federal regulatory intervention
to protect public health.
Regulating Pathogens
The present combination of market regulation and industry self-
policing has not resolved increasingly apparent problems with meat and
poultry [[Page 6875]] pathogens. Documented cases of foodborne illness
each year, some of which have resulted in death, represent a public
health risk that FSIS judges to be unacceptable. A Federal regulatory
program that reaches every level of meat and poultry production,
processing, distribution and marketing is the only means available to
society for lowering foodborne pathogen risks to an acceptable level.
FSIS further concludes that a mandatory HACCP program is the only means
of achieving this goal. Alternatives cannot achieve the reduction in
pathogens necessary to assure the maximum reduction in food illness. To
the extent that reductions in pathogen levels in meat and poultry can
be achieved with current technology and without causing significant
economic or social distortions, FSIS as a public health agency can
support no alternative to HACCP.
The economic argument supporting HACCP is that its benefits to
society outweigh the costs imposed by this proposal. Table 1 shows that
in terms of the costs and benefits that can be quantified, HACCP
implementation would generate considerable net benefits to society.
In addition, HACCP is supported by redistribution arguments that
are based on widely accepted social values. Public health legislation
itself clearly implies society's preference for having costs manifest
themselves as regulatory or production costs rather than as costs
associated with illness.
Even with demonstrated net benefits to society, it is important to
keep the HACCP costs to industry down as much as possible to avoid
unintended economic effects of HACCP implementation such as higher food
prices or putting firms out of business. The use of systematic process
control as reflected in the HACCP system would not require any
establishment to change its production process, and the costs of
monitoring a HACCP system are relatively small.
Thus, costs should have a minimal effect on the industry as a
whole. Table 2 shows the increased cost per pound of product based on
the estimated HACCP costs.
Table 2.--Effects on the Cost Per Pound of Meat and Poultry
----------------------------------------------------------------------------------------------------------------
Near-term and
1993 Four-year HACCP
Inspection program poundage* estimated implementation Cost per
(billion) poundage total costs pound
(billion) (million)
----------------------------------------------------------------------------------------------------------------
Total State and Federal.................................. 77.7 310.9 $733.5 $0.00236
----------------------------------------------------------------------------------------------------------------
*Poundage data is slaughter carcass weight for Federal and State establishments with 26 of 27 states reporting
slaughter data.
A reduction in the incidence of foodborne illness is the principal
performance goal for both USDA and industry. Mandatory HACCP
implementation is projected to produce a direct reduction in foodborne
illness with public health benefits estimated at $6.4-24.0 billion for
20 years (see Table 1). The Agency believes that these benefits clearly
outweigh industry discounted costs of $2.3 billion associated with
implementing and maintaining HACCP controls for 20 years.
III. Alternatives
A. Process Control Regulatory Strategy
FSIS has determined that effective process control is needed
throughout the meat and poultry industry in order to minimize pathogen
contamination and control other hazards in food products and lower the
risk of subsequent foodborne illness. Accordingly, a regulatory
strategy has been formulated to mandate process control improvements to
achieve immediate reductions and an eventual minimization of the risk
of meat and poultry pathogens in the Nation's food supply. Chemical and
physical hazards will also be prevented. This strategy is supported by
consumers, scientists, and the majority of meat and poultry industry
processors who already recognize the benefits of good process control.
Process control is a proactive strategy that all segments of
industry can undertake to anticipate manufacturing problems in advance
and prevent unsafe foods from ever being produced. In practice, process
control is a systematic means to:
identify and control production hazards;
determine control points in the processing system;
establish standard measures for each control point;
set procedures for plant workers to monitor requirements;
provide clear instructions for appropriate corrective
actions when a control point goes out of control;
establish record-keeping to document control point
measurements; and
provide procedures for product verification tests to
ensure system continues to operate as planned.
The process control strategy summarized in this paper is founded on
three principles:
1. USDA regulatory policy should be focused on providing a solution
to meat and poultry biological, chemical and physical hazards that
present the highest public health risks;
2. Pathogenic microorganisms--which present the greatest foodborne
risk to human health--are now present in significant percentages of raw
meat and poultry products; and
3. These pathogens and resulting risks of foodborne illness can be
largely avoided by uniform meat and poultry industry efforts to attain
and maintain more effective methods of control during the manufacturing
process.
The focus of this strategy is explicitly on prevention; it is
designed to prevent the production of defective product as opposed to
more costly and less effective detect-and-condemn methods.
Process control is not a substitute for inspection any more than
inspection could be a substitute for process control. This distinction
is important because Federal inspection was never intended to be--and
cannot be--the front-line control for food safety in meat and poultry
processing plants. Safety controls must be built into the manufacturing
process and be administered continuously by industry. The objective of
inspection in a process control environment is to assure that those
controls are present, adequate and are being used properly.
The primary benefits of a process control regulatory strategy are
that it will: (1) Provide industry the tools and incentive to reduce
meat and poultry pathogens as a means to improve food safety and (2)
help reorient Federal inspection to better address product,
[[Page 6876]] process and plant risks. A regulatory program that
imposes better manufacturing process control methods as a means to
reduce pathogen contamination and control other hazards emphasizes the
fact that industry is primarily responsible for product safety while
the Government's role is oversight.
B. Factors Considered in Evaluating A Process Control Strategy
The process control regulatory strategy was evaluated using five
factors for effectiveness. A processing control program is effective if
it:
1. Controls production safety hazards;
2. Reduces foodborne illness;
3. Makes inspection more effective;
4. Increases consumer confidence; and
5. Provides the opportunity for increased productivity.
The following sections discuss these five effectiveness factors
that have been applied to evaluate process control alternatives.
Controls Production Safety Hazards
Process control is a system for identifying food hazards and
reducing or eliminating the risks they present. In operation, control
points are established in a food production line where potential health
hazards exist; management of these points has proven to be effective in
reducing the probability that unsafe product will be produced. Ongoing
records of each process control will enable plant managers and quality
control personnel to spot trends that could lead to problems and devise
a strategy that prevents them before they occur.
Detection by end product testing is not a viable alternative to
process control because it only sorts good product from bad and does
not address the root cause of unacceptable foods.
Additionally, keeping ``bad'' foods out of commerce through sorting
end product is possible only when tests and standards for sampling are
well established and it is practical only where the ``test'' is not
expensive because sorting requires a huge number of samples for
reliability.
Reduces Foodborne Illness
As industry improves its control over the safety aspects of meat
and poultry production, foodborne illness will begin to decline. This
is the principal non-negotiable goal for both USDA and industry.
The precise occurrence of human health problems attributed to
pathogenic microorganisms or other potential foodborne hazards, such as
chemical contaminants, animal drug residues, pesticides, extraneous
materials, or other physical contaminants is not known. Foodborne
illness is nevertheless recognized by scientists around the world as a
significant public health problem and there is wide agreement that
pathogenic microorganisms are the major cause of food-related disease.
The cost of foodborne illness related to meat and poultry products
alone is between $4.5-7.5 billion annually.
Makes Inspection More Effective
Currently, FSIS inspectors in meat and poultry plants perform
random inspection tasks that generate independent data about a plant's
production processes and environment. This activity produces
``snapshots'' of plant operations at that moment. In contrast, process
control generates records of plant performance over time. These records
and periodic verification inspections will enable FSIS inspectors to
see how a plant operates at all times, i.e., whether and where
processing problems have occurred, and if so, how they were addressed.
The availability of more and better processing data will establish
trends that set benchmarks from which deviations can be more quickly
and accurately assessed. USDA inspectors will be trained to spot these
deviations and take action when needed to ensure plants bring a faulty
process back into control. This type of Federal oversight is
substantially more effective than a regulatory program that merely
detects and condemns faulty end products. In the words of the National
Advisory Committee on Microbiological Criteria for Foods,
``Controlling, monitoring, and verifying processing systems are more
effective than relying upon end-product testing to assure a safe
product.''
Increases Consumer Confidence
The number of foodborne illness outbreaks and incidents
attributable to pathogens in meat or poultry raise questions about
whether federal inspection is as effective as it should be. Highly
visible public controversies about meat and poultry inspection indicate
an erosion of public confidence in the safety of meat and poultry
products. There are growing demands that USDA improve its regulation of
pathogens. The process control regulatory strategy described in this
paper is USDA's response to those demands.
Many outbreaks of foodborne illness have been determined to be
caused by mishandling of meat and poultry products after federally-
inspected processing. USDA believes that additional efforts to reduce
pathogens during manufacturing will reduce these risks as well. This,
coupled with the improved retail regulatory controls from state
adoption and enforcement of the Food and Drug Administration's Food
Code should reduce this cause of illness.
A significant portion of the meat and poultry industry does not
take advantage of readily available methods to control its
manufacturing processes. This is due in large part to the fact that
meat and poultry processing industries are relatively easy to enter and
are composed largely of small and medium-sized firms. Managers in these
firms are frequently not as knowledgeable about safe production
practices as they should be.
The Department has concluded that further regulation will bring
industry standards up to what can practically be achieved in the
manufacture of meat and poultry products through current scientific
knowledge and available process control techniques. Raising the safety
floor through regulations that mandate better process controls will
demonstrate to the public that USDA and industry are making a concerted
effort to reduce the risk of foodborne illness from meat and poultry.
The economic benefits of increased consumer confidence can be
conceptually realized in the amount consumers would be willing to pay
for safer food. This overall `willingness to pay' is made up of several
components. It reflects consumer desires to avoid foodborne illness and
the expected medical and other costs associated with pathogens. In
theory the total benefit associated with processing control regulations
could be decomposed into two parts: first, the reduction in medical and
other costs associated with pathogen-related illnesses (as discussed in
a previous section), and the additional benefits which accrue to
consumers not made ill but who may place a value on reduced risk of
exposure to pathogens. At this time, the data are not available to make
quantitative estimates of the consumer's willingness to pay.
Provides the Opportunity for Increased Productivity
Better process control is a sound and rational investment in the
future of our nation's meat and poultry industry. USDA's process
control strategy will educate industry management about the need and
methodology for development of a consistent, preventive, problem-
solving approach to safety hazards, which can be expanded to other
business objectives such as product [[Page 6877]] quality and
production efficiency. There is much evidence of how process control
has improved worldwide industrial productivity in the past 40 years.
This proposal will extend process control principles to parts of the
meat and poultry industry that have not formerly used them.
Some important non-safety benefits that will accrue from industry
use of better process control methods are:
First, better production controls will result in more
efficient processing operations overall with fewer product defects.
Fewer defects mean less reworking, waste and give-away, resulting in
increased yields and more profit opportunities.
Second, better controls will significantly reduce the risk
to processors that product with food safety defects will slip into
commerce. Expensive and embarrassing product recalls can be entirely
avoided with proper process controls.
Third, better control of pathogens will impact all
microorganisms, including those responsible for decomposition,
resulting in quality improvements and longer shelf life for products.
Fourth, better production controls improve plant employee
productivity which improves profit opportunities.
C. Evaluation of Mandatory HACCP to Provide Process Control
Considering the five effectiveness factors of process control, the
most effective means for ensuring that all industry uses adequate
process control systems is a mandatory HACCP regulatory program. This
alternative clearly meets all five criteria described above. In fact, a
mandatory HACCP program was judged to be the only option that will
effect adequate processing improvements in all establishments
throughout the industry. Only through mandatory HACCP can pathogen
risks be minimized to the fullest extent possible; thereby reducing
foodborne illness to the maximum, improving effectiveness of
inspection, increasing consumer confidence, and ensuring a more viable
industry. No other alternative accomplishes as much in these five areas
as mandatory HACCP.
In summary, FSIS has determined that:
HACCP is a processing control strategy that has been
scientifically proven effective in food manufacturing plants; and,
therefore
Mandating HACCP systems in all plants under USDA
jurisdiction will protect the public from unreasonable risks due to
meat and poultry consumption.
HACCP is widely recognized by scientific authorities such as the
National Academy of Sciences and international organizations such as
the Codex Alimentarius. It is used today by a number of plants in the
food industry to produce consistently safe products. This approach has
been supported for years by numerous groups that have studied USDA meat
and poultry regulatory activities.
In 1983 FSIS asked the National Academy of Sciences to evaluate the
scientific basis of its inspection system and recommend a modernization
agenda. The resulting report, issued in 1985, was the first
comprehensive evaluation of a scientific basis for inspection. The 1985
NAS report provided a blueprint for change: it recommended that FSIS
focus on pathogenic microorganisms and require that all official
establishments operate under a HACCP system to control pathogens and
other safety hazards.
After urging the intensification of ``current efforts to control
and eliminate contamination with micro-organisms that cause disease in
humans,'' NAS encouraged USDA to ``move as vigorously as possible in
the application of the HACCP concept to each and every step in plant
operations of all types of enterprises involved in the production,
processing, and storage of meat and poultry products.''
The General Accounting Office (GAO) has also identified needed
improvements in USDA's present inspection system. In its reports and
congressional testimony, and in numerous publications, GAO has endorsed
HACCP as the most scientific system available to protect consumers from
foodborne illness. This sentiment is most clearly expressed in a May
1994 report, ``Food Safety: Risk-Based Inspections and Microbial
Monitoring Needed for Meat and Poultry,'' in which GAO recommended
development of a mandatory HACCP program that includes microbial
testing guidelines. GAO urged USDA to assist meat and poultry plants in
the development of their microbial testing programs by, among other
things, disseminating information on the programs already in operation.
A third major proponent of HACCP is the National Advisory Committee
on Microbiological Criteria for Foods (NACMCF), which was established
in 1988 by the Secretary of Agriculture to advise and provide
recommendations to the Secretaries of Agriculture and of Health and
Human Services on developing microbiological criteria to assess food
safety and wholesomeness. Since 1989 NACMCF has prepared a series of
reports on the development and implementation of HACCP. As one of its
first tasks, the Committee developed ``HACCP Principles for Food
Production'' in November 1989. In this report, the Committee endorsed
HACCP as a rational approach to ensure food safety and set forth
principles to standardize the technique. In 1992, the Committee issued
an updated guide, ``Hazard Analysis and Critical Control Point
System.''
In 1993 NACMCF defined the roles of regulatory agencies and
industry in implementing HACCP. ``The Role of Regulatory Agencies and
Industry in HACCP'' proposed responsibilities for FDA, USDA, and other
agencies and industry during various phases of HACCP implementation.
Similar suggestions for program change have been voiced by consumers,
industry, state and local government representatives, as well as other
constituent groups. For example, consumers at recent public hearings
and the HACCP Round Table supported implementation of mandatory HACCP
throughout the meat and poultry industry.
The meat and poultry industry has itself provided broad support for
HACCP as a means to control pathogens, emphasizing that HACCP-based
food production, distribution, and preparation can do more to protect
public health than any Federal inspection program. They have
recommended that HACCP be used to anticipate microbiological hazards in
food systems and to identify risks in new and traditional products.
State departments of health and agriculture have also endorsed the
HACCP approach.
D. Evaluation of Other Alternatives
FSIS examined six other approaches before determining that
mandatory HACCP was the most effective means for industry to eliminate
pathogens in meat and poultry:
1. Status quo;
2. Intensify present inspection;
3. Voluntary HACCP regulatory program;
4. Mandatory HACCP regulation with exemption for very small
establishments;
5. Mandatory HACCP regulation only for ready-to-eat products; and
6. Modified HACCP--recording deviations and responses only.
These alternatives were assessed using the five effectiveness
factors presented in the previous section. Since [[Page 6878]] FSIS's
goal is to achieve the maximum pathogen reduction possible, and none is
judged to be as effective as mandatory HACCP, the costs of these
alternatives are not relevant. The following six sections summarize the
appraisal of each alternative.
Status Quo
This option would essentially continue plant processing controls
and Federal inspection as they are now. Good plants with adequate
methods for managing process lines would probably remain under control.
The Agency, under its present authority, cannot shift resources out of
good plants so the situation of poor performing plants is unlikely to
change. This situation raises immediate questions about the first
factor--controls production safety hazards--being met. Experience has
proven that Federal inspection cannot substitute for management in
establishments which have difficulty producing safe product
consistently. Also, inspection cannot be as effective in the current
plant environment as in a process control plant environment.
Status quo does not target industry and inspection resources at
preventing hazards in areas of highest risk which leads to the greatest
reduction in foodborne illness (factor two). In addition, food safety
experts, consumers, and other observers have told USDA they are not
satisfied with pathogen control by organoleptic methods as practiced in
the present plant program. Doing nothing new would perpetuate consumer
doubts about the ability of Federal inspection to regulate pathogens
which is counter to factor four. Consequently, the Department has
concluded that business as usual is not an acceptable response to
proven problems with pathogens associated with meat and poultry
products. Agency public health responsibilities alone require that more
positive actions be taken.
Intensify Present Inspection
As one alternative to the proposed mandatory HACCP regulation, FSIS
could intensify its present inspection system i.e., focus new resources
on suspected areas of risk in each plant. This approach would assign to
FSIS responsibility for designing, testing and mandating by specific
regulation, process control systems for all meat and poultry products
with potential safety hazards. A major flaw with this approach is the
burden of ensuring a safe product would be placed largely on FSIS
instead of plant managers where it belongs. Plant management would have
little motivation to become knowledgeable about process control or to
implement process control systems.
Agency experience with mandating specific requirements has
sometimes succeeded, where HACCP-like regulations have been successful
in correcting food safety problems in certain ready-to-eat products.
However, these controls largely consisted of lethal heat treatments
applied during final product processing. This approach is obviously
inappropriate for product that is marketed raw which is most frequently
associated with meat and poultry foodborne illness.
Thus, intensified regular inspection fails to meet the primary
criterion for process control, i.e., control production safety hazards
at all stages of meat and poultry slaughter and processing. Related to
this failing, inspection would be ineffective without all plants
maintaining process control systems (factor three.) This option would
require significant resource increases and results in more of the same
type of Federal oversight which would be more costly to taxpayers
without the payback of significant reductions in foodborne illness
(factor two). With the burden of control and monitoring on USDA's
inspection force rather than plant managers, industry performance would
be unlikely to improve. Industry growth would be less certain which is
counter to meeting factor five.
Voluntary HACCP Regulatory Program
A voluntary HACCP program would not provide reduction of pathogens
uniformly across the processing spectrum (i.e., many in industry would
choose not to participate) and therefore would not be sufficient to
attain the necessary reduction in foodborne illness (factor two).
Voluntary HACCP would be implemented most frequently in plants with
good processing controls already, while plants with unsophisticated
controls would be less likely to participate. The explanation for this
flaw is to be found in simple economics and, to a large degree, the
attitudes of plant management. Plants with good processing controls now
are most likely to adopt HACCP voluntarily because their management
understands the linkage between how a product is handled during
preparation and its finished quality and safety.
Conversely, plants without good processing controls today are much
less likely to participate in a voluntary HACCP program. These plants
are more often operated by management that lacks the knowledge or
motivation to institute better processing controls. Nevertheless, it is
precisely this group of low performing plants that FSIS must reach to
attain its public health goal. Nothing short of a mandatory HACCP
regulatory program will be effective in bringing processing
improvements to these marginal performers.
The Agency's regulation permitting the use of voluntary Total
Quality Control (TQC) Systems provides a useful analogy to how
effective a voluntary HACCP program would be. TQC focuses on
establishment responsibility for meeting or exceeding the standards set
by FSIS for all operations that are conducted in a plant, including
incoming raw materials, processing procedures, critical limits for
product standards, and action limits for establishment quality control
personnel. These systems operate under Agency oversight with an
emphasis on timely and accurate record-keeping and the necessity for
appropriate action to be taken by an establishment when a limit set
forth in an approved system is met or exceeded. However, over the last
10 years the number of plants with active TQC Systems has declined from
a high of around 500 (approximately 8% of all plants) to the present
351 participating plants (approximately 5% of all plants). USDA
experience has shown that a voluntary approach to HACCP would provide
little assurance that a major portion of meat and poultry products had
been produced under controls designed to minimize food safety hazards.
Mandatory HACCP Regulation With Exemption for Small Establishments
Under this alternative, FSIS would mandate HACCP; but, provide an
exemption for small establishments as was done with nutrition labeling.
However, since major goals in implementing HACCP are to improve
processing controls and plant performance across all of industry
(factor one) as a means to achieve foodborne illness reductions (factor
two), this option is inherently flawed by exemption of plants that
perform the least process control. USDA inspection experience shows
that some of the small establishments which would be exempted under
this option have particular difficulties maintaining control over their
processing system.
While it is true that small establishments produce a minimal amount
of the total meat and poultry supply, they do produce a full range of
products, including those most frequently associated with foodborne
illness from the meat and poultry supply.
This option also fails on factor three--provide more effective
inspection. Two [[Page 6879]] different inspection systems would be
needed: one risk-based system to inspect HACCP plants with good
processing controls; the other to provide resource intensive coverage
for plants that largely do not. If the number of small plants continues
to increase, more inspection resources would be required.
Mandatory HACCP Regulation Only for Ready-to-Eat Products
This option would mandate HACCP only for establishments that
prepare ready-to-eat meat and poultry products, but not for plants that
produce raw products. However, this decision would leave the public
without adequate protection from pathogenic microorganisms clearly
associated with product marketed in raw form. Very little reduction in
the most frequent causes of foodborne illness (factor two) could be
anticipated from this approach.
Government inspection costs would continue to increase to provide
traditional resource-intensive inspection for slaughtering and allied
processing plants that would not be subject to mandatory HACCP. Since
most of the unsolved problems with pathogenic microorganisms are
associated with raw products, not on those which would be the subject
of this HACCP option, this is an especially inappropriate regulatory
approach.
Modified HACCP--Only Recording Deviations and Responses
A final alternative considered would be to mandate HACCP, modified
to eliminate the recordkeeping burden to the inspected industry,
especially small establishments. Specifically, this option would modify
the HACCP record-keeping principle so that instead of demanding
continuous records at critical control points, companies would need to
record only deviations from critical limits and the response to them.
This would mean that HACCP-controlled operations would not generate
continuous monitoring data to reflect the operation at critical control
points, but would only record data when deviations occurred. This
arrangement eliminates the continuous picture of plant operations which
is the underpinning of factor three--make inspection more effective.
Such an approach would substantially reduce the paperwork burdens
associated with mandatory HACCP as recommended by NACMCF and recognized
by CODEX. However, it would also seriously compromise the usefulness of
HACCP as a means to make inspection more effective and avoid program
cost increases. Regulatory officials need to have a system which can be
reviewed in its entirety, so that a comprehensive picture of the
process is available, not just the truncated version which grows out of
recording deviations.
IV. HACCP Benefits--Foodborne Illness
A. Incidence of Foodborne Illness in the United States
The safety of the meat and poultry supply has been widely discussed
during the past few years. Precise data on the incidence of illness
associated with meat and poultry or other food products are lacking.
There is no mandatory reporting system for such illnesses and there is
no complete national database on the occurrence of human health
problems that might be attributed to pathogenic microorganisms or
potential foodborne hazards, such as chemical contaminants, animal drug
residues, pesticides, extraneous materials, or other physical
contaminants. Foodborne illness is nevertheless recognized by
scientists as a significant public health problem in the United States,
and there is wide agreement among scientists that pathogenic
microorganisms are the primary cause of foodborne illness. The
following discussion focuses on pathogenic microorganisms.
Foodborne illness can strike individuals of all ages, sexes,
nationalities and socioeconomic levels. People have been getting sick
from foods throughout the ages; the reasons change but the problem
persists. The most common types of foodborne illness typically appear
as acute gastroenteritis with sudden onset of vomiting or diarrhea, or
both, with accompanying abdominal pain. Some episodes include fever,
prostration, shock, or neurological symptoms. The incubation period,
i.e., the time between eating and onset of first symptom, as well as
the type and duration of symptoms can vary from a few hours to several
days, depending on the etiological agent, the infected individual's
genetic predisposition and physical condition. In a percentage of the
population--especially among children, the elderly, and immuno-
compromised individuals--foodborne illness can be life-threatening.
Researchers estimate that between 6 and 33 million people, (between
3 and 14 percent of the population) become ill each year from
pathogenic microorganisms in their food. An estimated 6,000 to 9,000 of
these illnesses annually result in death. Other data show at least 18
million cases of diarrheal disease of foodborne origin occur in the
United States annually; another several million persons may be affected
by secondary person-to-person spread of infectious agents from cases
caused by consumption of pathogen-contaminated food.
Foods contaminated with pathogenic microorganisms can lead to
infection and illness in two major ways. The first is by direct
consumption of the contaminated food under conditions that allow the
survival of the pathogen or its toxin, such as when a meat or poultry
product is consumed raw or undercooked. The second way contaminated
product can lead to illness is through cross-contamination in the
processing plant (e.g. cooked product), kitchen or other food-handling
area, such as when the Salmonella-contaminated exterior of raw chicken
contaminates a cutting board, countertop, or kitchen utensil, which
then comes into contact with cooked product or foods consumed raw, such
as salad. For some pathogens, such as Salmonella, more cases of illness
result from cross-contamination than from direct consumption of
undercooked product. Poor hygiene by infected food handlers, plant
employees, etc, can also introduce pathogens which later cause illness.
Foodborne illness appears to have remained steady or increased
slightly during the last decade. Possible increases in foodborne
illness are variously attributed to changes in animal production
procedures, automated processing, increased reliance on fast foods,
greater use of prepackaged foods and microwave ovens, extended shelf-
lives, more complex distribution systems, urbanization, public naivete
about food manufacturing methods, and lack of knowledge about the
hygienic precautions required at all stages of food handling, including
preparation and serving. Other factors contributing to reported
increases may include better surveillance, improved reporting, more
sensitive diagnostic tests, emerging pathogens, and improved methods of
detecting pathogens and chemical residues.
Data for evaluating trends and the most common causes of foodborne
illness are compiled by the Centers for Disease Control and Prevention
(CDC), based on reported ``outbreaks'' of illness, discussed below.
Estimates of the current foodborne disease burden in the United
States are based on estimates of the annual incidence of disease.
Incidence estimates are the annual estimates of the new cases of
foodborne disease which occur each year. CDC compiles reports from
State and local health authorities of foodborne illness outbreaks where
[[Page 6880]] two or more persons have become ill from a common source.
These reported cases are only a fraction of the actual annual incidence
of foodborne disease cases for many reasons:
Symptoms typical of several forms of foodborne illness
include diarrhea, vomiting, abdominal pain, and physical weakness.
These symptoms are also common to a wide variety of bacterial and viral
infections not generally associated with food consumption.
Consequently, many treated cases of foodborne illness are generically
diagnosed as non-specific gastroenteritis or ``the flu'' and not
identified as being caused by a specific foodborne pathogen.
Most foodborne illness is transitory and self-limiting.
People often become sick within a few hours after consumption of
contaminated food, suffer acute symptoms, and recover spontaneously.
These people are unlikely to seek medical attention, and will not
become part of the reporting database.
While some foodborne pathogens cause illness within a few
hours of food consumption (Staphylococcus aureus and Salmonella), many
common pathogens cause illness after a lag of several days (E. coli
O157:H7 and Campylobacter) or weeks (Listeria monocytogenes). The
longer the lag between consumption and illness, the less likely the
connection to food will be made.
Individual cases of foodborne illness are excluded from
the CDC reporting system, except for botulism, toxic fish, mushrooms,
and certain chemical poisonings where one case constitutes an outbreak.
Around half of CDC's reported outbreaks and cases are
never identified with a causative pathogen.
CDC primarily relies upon voluntary reporting from State
and local health agencies which, in turn, rely on hospitals, clinics,
and individual health care professionals for information. All these
institutions have resource limitations and different disease reporting
requirements. For example, 12 States have no surveillance staff
assigned to monitor foodborne diseases.
For the 4 foodborne pathogens of greatest concern, the case and
severity estimates presented here are the ``best estimates'' of the
actual incidence of foodborne disease associated with specific
pathogens, rather than the fraction of cases actually reported to CDC.
Many of the ``best estimates'' were developed by the landmark CDC study
by Bennett, Holmberg, Rogers, and Solomon, published in 1987, which
used CDC surveillance and outbreak data, published reports, and expert
opinion to estimate the overall incidence and case-fatality ratio for
all infectious and parasitic diseases, and identified 17 as foodborne
pathogens. All the estimates of bacterial foodborne disease cases in
Table 3 are based on CDC data to estimate actual cases of foodborne
disease caused by each pathogen. (The estimated cases for the parasitic
disease, congenital toxoplasmosis, are based on various reports in the
medical literature.)
Table 3.--Reference Sources of Data for Selected Human Pathogens, 1993
----------------------------------------------------------------------------------------------------------------
Foodborne illness cases
Pathogen (#) Source(s) for case estimates
----------------------------------------------------------------------------------------------------------------
Bacteria:
Campylobacter jejuni or coli.................... 1,375,000-1,750,000 Tauxe; Tauxe et al.
Clostridium perfringens......................... 10,000 Bennett et al.
Escherichia coli O157:H7........................ 8,000-16,000 AGA Conference.
Listeria monocytogenes.......................... 1,616-1,674 Roberts and Pinner; Schuchat.
Salmonella...................................... 732,000-3,660,000 Helmick et al.; Bennett et al.;
Tauxe & Blake.
Staphylococcus aureus........................... 1,513,000 Bennett et al.
Parasite:
Toxoplasma gondii............................... 2056 Roberts, Murrell, and Marks.
----------------------------------------------------------------------------------------------------------------
Sources: American Gastroenterological Association Consensus Conference on E. coli O157:H7, Washington, DC, July
11-13, 1994.
Bennett, J.V., S.D. Holmberg, M.F. Rogers, and S.L. Solomon. 1987. ``Infectious and Parasitic Diseases,'' In
R.W. Amler and H.B. Dull (Eds.) Closing the Gap: The Burden of Unnecessary Illness. Oxford University Press,
New York.
Helmick, C.G., P.M. Griffin, D.G. Addiss, R.V. Tauxe, and D.D. Juranek. 1994. ``Infectious Diarrheas.'' In:
Everheart, JE, ed. Digestive Diseases in the United States: Epidemiology and Impact.
USDHHS, NIH, NIDDKD, NIH Pub. No. 94-1447, pp. 85-123, Wash, DC: USGPO.
Roberts, T., K.D. Murrell, and S. Marks. 1944. ``Economic Losses Caused by Foodborne Parasitic Diseases,''
Parasitology Today. vol. 10, no. 11: 419-423.
Roberts, T. and R. Pinner. ``Economic Impact of Disease Caused by Listeria monocytogenes'' in Foodborne
Listeriosis ed. by A.J. Miller, J.L. Smith, and G.A. Somkuti. Elsevier Science: Amsterdam, The Netherlands,
1990, pp. 137-149.
Schuchat, Anne, CDC, personal communication with T. Roberts at the FDA Science Forum on Regulatory Sciences,
Washington, DC, September 29, 1994.
Tauxe, R.V., ``Epidemiology of Campylobacter jejuni infections in the United States and other Industrialized
Nations.'' In Nachamkin, Blaser, Tompkins, ed. Campylobacter jejuni: Current Status and Future Trends, 1994,
chapter 2, pages 9-19.
Tauxe, R.V. and P.A. Blake, Salmonellosis. Chap. 12. In: Public Health & Preventive Medicine. 13th ed. (Eds:
Last JM; Wallace RB; Barrett-Conner E) Appleton & Lange, Norwalk, Connecticut, 266-268.
Tauxe, R.V., N. Hargrett-Bean, C.M. Patton, and I.K. Wachsmuth, 1988, ``Campylobacter Isolates in the United
States, 1982-1986,'' Morbidity and Mortality Weekly Report, vol. 31, no. 88-2.
Data collected by CDC also show food source for foodborne illness.
Food products of all types, including beef, pork, turkey, chicken,
bakery products, dairy products, eggs, finfish, shellfish, ice cream,
mushrooms, fruits and vegetables, are associated with foodborne
illness. Among foodborne illness outbreaks reported to CDC, the
majority of those which can be identified are traced to pathogenic
bacteria. The six target pathogens account for nearly all meat and
poultry foodborne illness outbreaks and about 75% of total reported
outbreaks caused by a bacterial agent.
B. Costs of Foodborne Illness
Table 4 shows the estimated cost of all foodborne illness to be
approximately $5.6-9.4 billion in 1993. [[Page 6881]] Meat and poultry
products are associated with approximately $4.5-7.5 billion and the
remaining $1.1-1.9 billion is associated with non-meat and poultry
sources.
Table 4.--Foodborne Illness Costs and HACCP Benefits, 1993
------------------------------------------------------------------------
Foodborne illness
-------------------------
Food source Costs Benefits
billions) (billions)
------------------------------------------------------------------------
All Foods..................................... $5.6-9.4
Non-meat and Poultry...................... $1.1-1.9
Meat and Poultry Only..................... $4.5-7.5
Meat and Poultry Parasitic Pathogens.. $2.7
Meat and Poultry Bacterial Pathogens.. $1.8-4.8
USDA Target Bacterial Pathogens....... $1.1-4.1
Campylobacter jejuni/coli--.5-.8
E. coli 0157:H7--.2-.5
Listeria monocytogenes--.1-.2
Salmonella--.3-2.6
Reduction of USDA target pathogens attributed
to HACCP (90%) ........... .99-3.7
------------------------------------------------------------------------
Source: Economic Research Service and Centers for Disease Control and
Prevention.
The proposed HACCP system is designed to control all of the public
health hazards identified in each meat and poultry establishment. FSIS
regulation currently and under HACCP will address all public health
hazards. Table 5 shows the bacterial pathogens largely responsible for
meat and poultry illnesses.
The proposed near-term requirements and significant parts of HACCP
will target pathogen reduction on carcasses and raw product, currently
the least systematically controlled hazard. This is the most effective
overall approach for reducing pathogen contamination. The benefits are
calculated for the three most common enteric pathogens of animal
origin: Campylobacter jejuni/coli, E. coli 0157:H7, Salmonella and one
environmental pathogen Listeria monocytogenes. The reduction of these
pathogens to as near to zero as possible in meat and poultry during
slaughter and processing would produce an estimated 90% reduction in
the foodborne illness attributed to these microbial pathogens. The
remaining 10% are due to causes not affected by the proposed
regulations because contamination also occurs after product leaves the
inspected plant. (The estimated reduction is based on the expert
judgement of FSIS microbiologists.) This would result in a $.99-3.69
billion saving annually, as shown in Table 4.
Two other pathogens--Clostridium perfringens and Staphylococcus
aureus--primarily enter meat and poultry foods in restaurants, other
commercial kitchens and in homes. Consequently, the proposed regulatory
program, which focuses on federally inspected processing, will not
significantly affect the incidence of disease caused by these
organisms. It is expected, however, that the FDA's Food Code will
dramatically reduce the cause of illness attributable to retail
practices upon its adoption and implementation. Our continued consumer
education activities coupled with safe handling labels should
significantly impact practices in the home.
The costs described in this section for foodborne illness costs are
borne not only by those who become ill, but by their families, and
employers; the food industries; and taxpayers. Costs to stricken
individuals include medical bills, time lost from work, pain, and
inconvenience. Food industry costs include product recalls, loss of
plant production due to closings for cleanup, and higher premiums for
product liability insurance. Perhaps most costly to industry in the
long-term is loss of product reputation and reduced demand when an
outbreak is traced back and publicized. These and other ``defensive''
industry costs of foodborne disease run in the millions of dollars
annually and are, for the most part, entirely avoidable. Taxpayer costs
include medical treatment for those who cannot afford it, including
higher health insurance premiums and costs of public assistance to
disabled individuals and their dependents.
Table 5.--Medical Costs and Productivity Losses Estimated for Selected Human Pathogens, 1993
----------------------------------------------------------------------------------------------------------------
Total
Foodborne illness cases Foodborne* Percent costs* meat/
Pathogen (#) costs (bil. from meat/ poultry
$) poultry (%) (bil. $)
----------------------------------------------------------------------------------------------------------------
Bacteria:
Campylobacter jejuni or coli................ 1,375,000-1,750,000 0.6-1.0 75 0.5-0.8
Clostridium perfringens**................... 10,000 0.1 50 0.1
Escherichia coli O157:H7.................... 8,000-16,000 0.2-0.6 75 0.2-0.5
Listeria monocytogenes...................... 1,616-1,674 0.2-0.3 50 0.1-0.2
Salmonella.................................. 732,000-3,660,000 0.6-3.5 50-75 0.3-2.6
Staphylococcus aureus**..................... 1,513,000 1.2 50 0.6
---------------------------------------------------------------
Subtotal................................ 3,639,616-6,950,674 2.9-6.7 N/A 1.8-4.8
Parasite:
Toxoplasma gondii........................... 2,056 2.7 100 2.7
---------------------------------------------------------------
[[Page 6882]]
Total................................... 3,641,672-6,952,730 5.6-9.4 N/A 4.5-7.5
----------------------------------------------------------------------------------------------------------------
Source: Economic Research Service and Centers for Disease Control and Prevention, 1993.
*Column rounded to one decimal place.
**Roberts' rough approximation of costs in ``Human Illness Costs of Foodborne Bacteria'', Amer. J. of
Agricultural Economics, vol. 71, no. 2 (May 1989) pp. 468-474 were updated to 1993 dollars using the Consumer
Price Index (all items, annual average). Cost estimates for other pathogens are more detailed, see the
following for a discussion of the methodology: listeriosis--Roberts, Tanya and Robert Pinner, ``Economic
Impact of Disease Caused by Listeria monocytogenes'' in Foodborne Listeriosis ed. by A.J. Miller, J.L. Smith,
and G.A. Somkuti. Elsevier Science: Amsterdam, The Netherlands, 1990, pp. 137-149, E. coli O157:H7--Roberts,
T. and Marks, S., ``E. coli O157:H7 Ranks as the Fourth Most Costly Foodborne Disease,'' FoodReview, USDA/ERS,
Sept-Dec 1993, pp. 51-59, salmonellosis--Roberts, Tanya, ``Salmonellosis Control: Estimated Economic Costs,''
Poultry Science. Vol. 67 (June 1988) pp. 936-943, campylobacteriosis--Morrison, Rosanna Mentzer, Tanya
Roberts, and Lawrence Witucki, ``Irradiation of U.S. Poultry--Benefits, Costs, and Export Potential,
FoodReview, Vol. 15, No. 3, October-December 1992, pp. 16-21, congenital toxoplasmosis--Roberts, T., K.D.
Murrell, and S. Marks. 1944. ``Economic Losses Caused by Foodborne Parasitic Diseases,'' Parasitology Today.
vol. 10, no. 11: 419-423; and Roberts, Tanya and J.K. Frenkel, ``Estimating Income Losses and Other
Preventable Costs Caused by Congenital Toxoplasmosis in People in the United States,'' J. of the Amer.
Veterinary Medical Assoc., vol. 196, no. 2 (January 15, 1990) pages 249-256.
N/A indicates item is not-applicable.
Other taxpayer costs include public health sector expenses to
operate a disease surveillance system and to investigate and eliminate
disease outbreaks. Approximately $300 million is spent for this
annually by the Federal public health sector. Government costs in the
United States, Canada, and other countries, average about $200,000 per
foodborne illness outbreak.
Cost Computation Methodology
The costs of foodborne disease associated with meat and poultry
pathogens were estimated using a traditional ``cost of illness'' method
which includes medical costs, productivity losses, and special
educational or residential care associated with some chronic
conditions. Disease frequencies reflect CDC's ``best estimate'' of the
actual number of foodborne illness cases each year.
The present value of lifetime medical costs for those becoming ill
in 1993 was estimated using nationwide databases, such as published
Medicare reimbursement rates and per-capita expenditures on physicians'
services from the Health Care Financing Administration, the National
Center for Health Statistics' National Hospital Discharge Survey, the
American Hospital Association's Hospital Statistics, or Blue Cross/Blue
Shield charges. The average cost to community hospital per patient was
used to compute hospitalization costs.
Productivity losses occur because workers are ill and miss work.
These have been approximated by the Average Weekly Earnings for non
supervisory production workers in private nonagricultural jobs,
published by the Bureau of Labor Statistics (BLS) of the U.S.
Department of Labor, plus estimated fringe benefits. For illness in
subsequent years, a present value of the reduced stream of earnings is
calculated. For deaths, Landefeld and Seskin's human capital/
willingness to pay method was used. It combines elements of both
methods to generate the present value of expected lifetime after-tax
income and housekeeping services at a 3-percent real rate of return,
adjusted for an annual 1-percent increase in labor productivity and a
risk-aversion premium that increases the estimates by 60 percent.
These cost estimates are based on the annual incidence of disease,
rather than the prevalence, to help us estimate preventable illness.
Incidence estimates are the annual increase in cases and associated
disease costs. Interventions today which prevent future costs will
eliminate all the medical, productivity, and special care costs of
prevented cases, and so represents one component of the overall
economic benefit of disease prevention.
C. The Relationship Between Foodborne Illness and Consumer Knowledge
and Behavior
The National Academy of Science's Cattle Inspection: Committee on
Evaluation of USDA Streamlined Inspection System for Cattle (SIS-C)
(1990) repeated the theme of numerous other studies, stating ``. . .
the public expects the government to ensure zero risk of meat-borne
disease through inspection. The [NAS] committee heard little evidence
that the public is aware that some bacterial contamination of raw meat
is inevitable and no mention of the crucial role of food handling,
preparation, and serving methods in limiting foodborne diseases.'' The
disturbing but real fact that consumers fail to make a connection
between their food handling behavior and safe food recurs throughout
the literature on the subject.
Behavioral research shows that food habits are the most difficult
of all forms of human behavior to change. This finding is supported by
research of consumer knowledge and practices, which indicate that a
large portion of the U.S. population lacks basic food safety
information and skills and engages in food handling and preparation
practices that epidemiological studies have linked with a significant
number of foodborne illness outbreaks. Moreover, little correlation
exists between consumers' food safety knowledge and their food handling
and preparation practices. Even people who characterize themselves as
``knowledgeable'' do not necessarily follow good food safety
procedures. The CDC estimates that 20-30 percent of foodborne illness
is due in part to consumer mishandling of food.
Available evidence concerning consumer behavior related to safe
food handling and preparation supports the need for a comprehensive
pathogen reduction effort. Food safety can best be assured by
establishing a ``chain of responsibility,'' with each participant in
the food system, from the producer all the way through to the
consumer--understanding, accepting, and acting on its responsibility
for food safety. While FSIS will pursue and support all possible means
of consumer education and outreach, the Agency realizes that consumer
education alone will not control pathogen-related foodborne illness.
This is even more true today than ever before, as more people in our
society are assuming responsibility for food handling and preparation
in the home and elsewhere, without [[Page 6883]] experience in food
preparation and knowledge of safe food handling and storage methods.
These people include:
Food service workers, many of whom receive inadequate
training, are part-time and teenagers, who experience high-turnover;
Men and women in the workplace, who have minimal time for
food preparation and often little experience or interest in food
preparation;
Children, who are increasingly expected to shop and
prepare their own meals;
Immigrants, who might not be able to read food handling
instructions, or whose cultural practices include eating raw or very
rare meat and poultry products. Other vulnerable sectors of the
population, more severely affected by foodborne illness, are also
increasing in size;
Immunocompromised persons (i.e., persons with diabetes,
cancer, chronic intestinal diseases, organ transplants, and AIDS);
Persons 65 years and older--a growing proportion of the
population--who, due to the normal decline in immune response, are at
increased risk.
In 1993, to increase awareness about pathogens, FSIS promulgated a
regulation requiring safe handling labels on most raw meat and poultry
products. The Agency's Meat and Poultry Hotline provides consumers with
immediate responses to questions about food handling and safety. These
steps are important but they are not a substitute for building into the
food production and regulatory system measures to reduce to the maximum
extent possible the presence of microbial pathogens in meat and poultry
products purchased by U.S. consumers.
V. Costs Associated With HACCP
This section details the costs to the meat and poultry industry of
the proposed measures to control pathogenic microorganisms and other
biological, physical and chemical hazards. Unless otherwise stated, the
figures used are three-year undiscounted costs. They have been
estimated for:
Four near-term initiatives that could be implemented
shortly after promulgation of a final rule. These include the creation
of Standard Operating Procedures (SOPs) for sanitation and three
pathogen reduction and control interventions: antimicrobial treatment
of carcasses, microbiological testing, and time and temperature
requirements for all raw product received, held, and shipped by
inspected establishments.
The longer-term Hazard Analysis and Critical Control Point
(HACCP) systems developed by establishments would be phased in over an
approximate three-year period after the final rule is promulgated.
Total cost of the near-term initiatives and the three-year HACCP
implementation is estimated at $733.5 million. This includes $552.8
million for federally inspected establishments and $180.7 million for
State establishments. The costs for small establishments, which make up
about a third of the total establishments, are estimated at $330.6
million, or just under 45 percent of the total. The Agency recognizes
the problem these costs could present to small firms and has requested
in the proposal public comments that will help it make appropriate
adjustments to modify this burden.
A. Cost Analysis Procedures
In estimating the costs of the proposed rule, FSIS used data
generated by various Agency operational and research components such as
Total Quality Control (TQC), Partial Quality Control (PQC), and the
various Baseline Microbiological Surveys. An especially important
source was the cost information from the HACCP Pilot Program conducted
from 1991 to 1993. The cost analysis also relied heavily on four of the
Agency's main databases.
New databases were created by merging selected variables from the
four FSIS databases and enhancing them with additional economic and
financial data. The Enhanced Economic Analysis Database contains
information on each of the slaughter and processing establishments
active as of August 1994.
Described below as a prelude to the sections containing the
estimated near-term and long-term costs are the assumptions, criteria,
and other factors underlying or used in this cost analysis. Details of
cost methodology and estimations are available in an appendix.
1. Number of Establishments
There are 6,186 Federal slaughter, processing, and combination
(performing both slaughter and processing operations) establishments.
An additional 2,893 establishments fall under State inspection. For
some cost analysis purposes, combination establishments (performing
both slaughter and processing) were counted as two separate plants.
2. Establishment Size
For its cost analysis, FSIS defines a small establishment as one
with less than $2.5 million in annual sales. (This definition does not
coincide with the Small Business Association definition for a small
business.) Using the FSIS criterion, 42.2 percent of processing plants
(Federal and State) and 16.8 percent of slaughter plants would be
considered small establishments. A medium establishment is defined as
one with annual sales of more than $2.5 million and less than $50
million. A large establishment is one whose sales are greater than $50
million per year.
State establishments are all considered to be small establishments.
Since figures on these plants' sales volumes were not available, the
size determination was based on amount of production, which was below
the average for Federal establishments with sales less than $2.5
million. FSIS invites comments on the State classifications.
3. Process Categories
In keeping with the process control principles inherent in HACCP,
FSIS identified 14 process categories (see Table 6 at the end of this
section.) There is a separate category for each of the nine actual
slaughter and processing processes and for each of the five species
slaughtered. FSIS believes the 14 categories encompass all the products
of the regulated industry. Every plant must develop a HACCP plan for
each applicable category. The estimated costs for plan development are
based on the total number of processes in all plants.
4. Implementation Schedule
FSIS plans that the final rule will become effective. The near-term
initiatives would go into effect three months after it is published in
the Federal Register and remain in effect in each plant until that
plant's HACCP program begins (except for the sanitation SOP's, which
will continue with HACCP). HACCP implementation would be phased in by
process over three years, from date of final rule promulgation, with
each process category assigned a slot in that time frame when its HACCP
plan would be implemented. Small plants would have the option of
implementing the plans for all their processes three years from
promulgation instead of implementing plans for individual processes
according to the time frame for medium and large plants.
5. Compliance
Some establishments may find that their present process(es) cannot
consistently produce product that meets the specified interim target.
This target, although a new ``measure'' of safety, is
[[Page 6884]] based on levels currently achieved by many industry
plants and is considered by the Agency to represent the current
acceptable level of safety. An establishment whose product does not
meet the target under the proposed requirements must, as it must do
under current regulations, take action to adjust its process to produce
product that meets this standard. The cost of taking this action is not
considered a cost of the proposed requirement.
6. Equipment and Materials
The proposed rule does not make any existing equipment obsolete.
(Some modification may be necessary, however, such as increasing
cooling capacity for complying with the time-and-temperature
requirements.) The proposal does require establishments to
systematically monitor their processes. Costs of the necessary
materials, such as thermometers and test kits, are estimated at $10 to
$20 per establishment.
7. Wages
The hourly wage rates used in estimating costs are based on data
from the Bureau of Labor Statistics and Meat and Poultry Magazine. They
are $25.60 for a quality control manager, $18.13 for a quality control
technician, and $12.87 for a laborer. They include a 33 percent
overhead rate.
8. Cost Offsets
Because many establishments are currently operating or capable of
operating quality control systems and programs, total costs are reduced
to the extent that establishments already have the required plan
development, monitoring, record keeping, and training.
9. TQC Overtime Costs
With the publication of the rule, TQC plants could lose their
authority to produce and ship product after their normal shift
production time. As a result, 287 active TQC establishments could begin
to incur annual overtime charges.
B. Costs of the Near-term Initiatives
Costs associated with the four near-term initiatives can be thought
of as pre-implementation HACCP costs. Since these interventions or
similar controls will for the most part be incorporated into HACCP
systems, their cost will reduce the overall cost of HACCP. Total cost
of these initiatives is estimated at $358.9 million, including $266.7
for Federal establishments and $92.3 million for State establishments.
The estimated cost to small establishments is $172.9 million. The four
initiatives and their estimated costs are described below.
1. Sanitation Standard Operating Procedures
Federal plants--$81.1 million
State plants--21.0 million
Total--$102.1 million
Small establishments--$50.4 million
The SOPs would not add new sanitation standards but would require
documentation of cleaning and sanitizing procedures for all equipment
and facilities involved in the production of every product. This would
serve as a basis for the plant's monitoring and the inspector's
verification. An establishment's owner or manager would be required to
detail in a written plan how the basic sanitation requirements would be
met. Establishment employees would record results of the daily
sanitation checks on a checklist, which would be made available to the
inspector.
The amount of time to develop the plan would vary by establishment
size, equipment, production capacity, and the process being performed.
Plan development costs are one-time costs which would be incurred in
the six months before the effective date of the regulation. They are
estimated at $1.99 million for Federal establishments and $0.522
million for State establishments. Establishments now following a
written sanitation program are not considered in the one-time or the
recurring cost estimates.
Training establishment employees in the requirements of the SOP
intervention program would represent another one-time cost incurred in
the six months before the regulation takes effect. The training cost
for Federal establishments is estimated at $1.1 million and for State
establishments $0.251 million.
Recurring SOP costs would involve recordkeeping. Annual record
keeping costs are estimated at $19.5 million for Federal establishments
and $5.1 for State establishments.
2. Antimicrobial Treatments
Federal plants--$58.7 million
State plants--0.6 million
Total--$59.4 million
Small establishments--$2.7 million
Slaughter establishments would be required for the first time to
provide antimicrobial treatments before the carcasses enter the chiller
or cooler. Costs are reduced by the number of establishments already
meeting these requirements. In estimating the resulting costs, it is
assumed that the establishments would use the most cost-effective
treatment. For meat establishments the cost analysis is based on the
hot water system, at a cost of $.08 per carcass. For poultry
establishments it is based on a hypochlorination system at $.0125 per
carcass.
3. Time and Temperature Requirements
Federal plants--$26.5 million
State plants--22.9 million
Total--$49.4 million
Small establishments--$28.8 million
These requirements are already in effect for poultry plants, so
would affect only the meat industry. An establishment would be required
to maintain the cooled carcass and raw meat at the specified
temperature throughout handling, holding, and shipping to other
official establishments. Costs are reduced by the number of meat
establishments already meeting these requirements. First-year costs for
Federal establishments are estimated at $13.7 million, which covers
developing a plan, training employees, upgrading cooling equipment, and
keeping records. For State establishments the estimate is $18.9
million.
4. Microbiological Testing
Federal plants--$100.3 million
State plants--47.8 million
Total--$148.1 million
Small establishments--$91.1 million
FSIS would mandate testing and reporting procedures to determine
the pathogen incidence rate for each process at each establishment that
slaughters livestock or poultry or produces raw, ground meat or poultry
products. One-time costs for plan development and employee training are
estimated at $6.7 million.
Specimens would be collected once a day at the end of the
production process and tested for the presence of the target organism
(Salmonella) in the establishment's own laboratory or in a commercial/
contract laboratory. The sample collection and analysis cost in the
first year after promulgation of the rule is estimated at $67.5
million. This includes $46.4 for Federal establishments and $21.1
million for State establishments. The cost for small establishments
represents 59 percent of the total, or $39.8 million.
First-year costs for record keeping are estimated at $2.4 million.
Large establishments account for only about 10 percent of this total,
since most of them are already performing quality control functions
which require continuous records. [[Page 6885]]
C. Costs of the Long-term HACCP Intervention
Federal plants--$279.7 million
State plants--88.5 million
Total--$368.2 million
Small establishments--$157.6 million
The near-term initiatives are a prelude to the types of activities
that are required under a HACCP process control system. The HACCP costs
above, which represent the full 36-month implementation period, include
continuing components of the previous initiatives and the new costs
listed below:
1. Industry HACCP Training
FSIS would require that each establishment have at least one person
complete a course of at least three days in the application of HACCP
principles. The total estimated cost of $27.9 million was calculated by
multiplying a per-course cost of $2,514 (for tuition, travel expenses,
and labor replacement) by the number of Federal and State
establishments now lacking someone with the necessary training (assumed
to be 95 percent of establishments).
2. Plan Development
FSIS would require each inspected establishment to have and
implement a HACCP plan that is specific to each kind of meat or poultry
process performed in the establishment. The Agency is aware that the
requirement may be especially burdensome to small establishments
producing small amounts of a variety of products.
In estimating the cost of the plans, FSIS considered the difficulty
of writing a plan for each of the 14 HACCP processes that encompass all
meat and poultry products. The cost for developing a plan ranges from
$2,000 to $15,000 according to the degree of difficulty and its order
of development. The overhead costs of developing the plant's first plan
do not appear again for its subsequent plans.
Total plan development costs are estimated at $42.9 million: $30.7
million for Federal establishments and $12.2 million for State
establishments. (In the absence of production information for State
establishments, it was assumed that each will have 1.5 plans.) The
total for small establishments is $21.6 million.
3. Aseptic Training
Plants not covered by the near-term microbiological testing
requirement and that do not have their own quality control laboratory
would have to train an employee to collect specimens for analysis.
Estimated costs are $1.5 million for Federal plants and $.6 million for
State plants. The total for small establishments is $1.5 million. (This
cost is related to product testing. See item 4 below.)
4. Product Testing
The pre-HACCP product testing in slaughter plants and plants
producing raw, ground product would continue under HACCP as described
above under short-term initiatives. In addition, the Agency intends to
require product testing in the processing plants not covered by the
short-term requirement. Although the precise nature of this testing is
not yet known, the Agency expects that in every establishment, at least
one sample a day would have to be taken for each process. This would
amount to nearly six million samples a year, at an estimated annual
cost of $149.8 million. Although this testing requirement is not
included in the proposed rule, it is discussed in the preamble and is
included in the proposed costs in order to give a realistic estimate of
the ultimate costs of the effort that is being initiated by this
proposal.
5. Recordkeeping
A fundamental HACCP principle calls for recording and reviewing
observations at critical points in the manufacturing process on an
ongoing basis. The cost of recording this information is expected to
total $47.9 million annually: $41.7 million for Federal establishments
and $6.3 million for State establishments. The recording costs for
small establishments are estimated at $11.9 million.
The cost of reviewing the records generated is expected to total
$28.0 million annually: $24.5 million for Federal establishments; $3.5
for State establishments. The annual reviewing cost for small
establishments is estimated at $6.7 million.
The annual cost of maintaining (storing) HACCP records as required
would be $671,813: $575,852 for Federal establishments; $95,961 for
State establishments.
6. FSIS HACCP Training
FSIS would provide employees with awareness training and HACCP
inspection activity training. The estimated cost is $416,880.
D. Estimated Costs Per Plant
The following charts show the estimated costs for the near-term
initiatives and for HACCP that would be incurred by various types of
plants. The following steps can be followed to estimate, on the basis
of FSIS estimates of cost, how much a particular establishment could
expect to spend on one-time and recurring costs during the
implementation period:
1. Determine the establishment's size (small, medium, or large)
according to its annual sales volume, using the following criteria:
Small=less than $2.5 million sales
Medium=$2.5-$50 million sales
Large=over $50 million sales
2. Using the table for that size plant, find the column that
describes its function (meat slaughter, poultry slaughter, or
processing). Note that each type of operation is subdivided into two
groups: those with and those without their own quality control
laboratory. Plants with a laboratory will not have to spend as much in
some cost categories. On the table for small plants, it is assumed that
none have their own laboratory. On the table for large plants, it is
assumed that all processing but not all slaughter plants have their own
laboratory.
3. In meat slaughter plants, the HACCP costs for plan development
and record keeping are per process, with each species counted as a
separate process. For meat plants slaughtering more than one species,
both costs must be multiplied by the number of species.
In poultry slaughter plants, only the HACCP cost for record keeping
should be multiplied by the number of species slaughtered (chicken,
turkey, and/or duck).
4. In processing plants, the HACCP costs for plan development and
record keeping vary from process to process according to whether the
process--and thus its HACCP plan--is easy, moderate, or difficult. To
calculate a plant's total HACCP plan development and record keeping
costs, perform these steps:
For each process, use Table 6 to determine its degree of
difficulty, and then, again using the relevant plant-size chart, find
the plan development cost and the record keeping cost for that process.
Write them down.
Add all the plan development costs.
Add all the record keeping costs.
Use the two sums instead of the table's per-process costs when the
plant's total HACCP costs are calculated.
5. Under near-term interventions, note that modifying a cooler to
comply with time-and-temperature requirements would cost an estimated
$6,000. Any plant needing such modification should add $6,000 to the
near-term interventions subtotal.
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Table 6.--Degree of Difficulty for Developing a HACCP Plan
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Plan No. HACCP process Degree of difficulty
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1.......... Raw: Ground.................................................................. Easy.
2.......... Raw Other: Inclusive......................................................... Easy.
3.......... Thermally processed.......................................................... Difficult.
4.......... All other shelf stable: not heat treated..................................... Difficult.
5.......... Fully cooked: not shelf stable............................................... Moderate.
6.......... Shelf stable: heat treated, other............................................ Moderate.
7.......... Non-shelf stable: heat treated, not fully cooked............................. Moderate.
8.......... Non-shelf stable: with secondary inhibitors.................................. Moderate.
9-14....... Slaughter.................................................................... Easy.
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