[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.

-----------------------------------------------------------------------

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

1. Booz, Allen, and Hamilton, Inc. Study of the Federal Meat and 
Poultry Inspection Program, Volume 1--Description of the Meat and 
Poultry Inspection Program, June 1977, Volume II--Opportunities for 
Change--An Evaluation of Specific Alternatives, June 1977, Volume 
III--Executive Summary, July 1977. 
2. General Accounting Office Report, December 9, 1977, CED-78-11. A 
Better Way for the Department of Agriculture to Inspect Meat and 
Poultry Processing Plants.
3. FSIS, 1978. A Strengthened Meat and Poultry Inspection Program.
4. NAS, 1990--Committee on Evaluation of USDA Streamlined Inspection 
System for Cattle (SIS-C). 1990. Cattle Inspection. Food and 
Nutrition Board, Institute of Medicine, National Academy of 
Sciences. National Academy Press, Washington, DC.
5. Council for Agricultural Science and Technology publication Food 
Borne Pathogens: Risk and Consequences, Task Force Report 122, 
September 1944, Chapter 6, Risk Characterization: Economic cost of 
food borne diseases.
6. FSIS, January 1994. Nationwide Beef Microbiological Baseline Data 
Collection Program--Steers and Heifers--October 1992 --September 
1993.
7. NRC 1985. Committee on the Scientific Basis of the Nation's Meat 
and Poultry Inspection Program. Meat and Poultry Inspection: The 
Scientific Basis of the Nation's Program. Food and Nutrition Board, 
Committee on Life Sciences, National Research Council, National 
Academy Press, Washington, D.C.
8. NRC 1987, Committee on Public Health Risk Assessment of Poultry 
Inspection Programs. Poultry Inspection: The Basis for a Risk-
Assessment Approach. Food and Nutrition Board, Commission on Life 
Sciences, National Research Council, Washington, D.C.
9. General Accounting Office Report, May, 1994, GAO/RCED-94-110. 
Food Safety: Risk-Based Inspection and Microbial Monitoring Needed 
for Meat & Poultry.
10. General Accounting Office Report, February 10, 1994, GAO/TCED-
94-123. Meat Safety: Inspection System's Ability to Detect Harmful 
Bacteria Remains Limited. 
11. General Accounting Office Report, November 4, 1993, GAO/RCED-94-
71. Food Safety: A Unified, Risk-Based System Needed to Enhance Food 
Safety.
12. General Accounting Office Report, March 16, 1993, GAO/RCED-93-
27. Food Safety: Building a Scientific Risk-Based Meat and Poultry 
Inspection System.
13. General Accounting Office Report GAO/T-RCED-93-10, February 18, 
1993. Food Safety: Inspection of Domestic and Imported Meat Should 
be Risk-Based.
14. General Accounting Office Report GAO/RECD-92-152, June 1992. 
Food Safety and Quality: Uniform Risk-Based Inspection System Needed 
to Ensure Safe Food Supply. 
15. James, W.O.; J.C. Prucha; Brewer R.L.; W.O. Williams; W.A. 
Christensen; A.M. Thaler; and A.T. Hogue. 1992. Effects of 
countercurrent scalding and postscald spray on the bacteriologic 
profile of raw chicken carcasses. J.A.V.M.A. 201:705-708.
16. Blankenship, L.C.; J.S. Baily; N.A. Cox; M.T. Musgrove; M.E. 
Berrand; R.L. Wilson; M.J. Rose; and S.K. Dua. 1993. Broiler carcass 
reprocessing, a further evaluation. J. Food Prot. 56:983-985.
17. Patterson, J.T. 1969. Hygiene in meat processing plants. 4. Hot 
water washing of carcasses. Record of Agr. Res. Ministry of Agr. 
Northern Ireland. 18-pp. 85-87.
18. Smith, M.G. and Graham, A. 1974. Advanced meat science 
techniques I: Meat chilling and handling. Brisbane, CSIRO Div. Food 
Res. Lab. 5pp.
19. Smith, M.G. and Graham. A. 1978. Destruction of Escherichia coli 
and Salmonella on mutton carcasses by treatment with hot water. Meat 
Sci. 2:119-128.
20. Davey, K.R. 1990. A model for the hot water decontamination of 
sides of beef in a noval cabinet based on laboratory data. Int. J. 
Food Sci. 25:88-97.
21. Davey, K.R. 1989. Theoretical analysis of two hot water cabinet 
systems for decontamination of sides of beef. Int. J. Food Sci. 
24:291-304.
22. Kelly, C.A.; J.F. Dempster; and A.J. McLoughlin. 1981. The 
effect of temperature, pressure and chlorine concentration of spray 
washing water on number of bacteria on lamb carcasses. J. Appl. 
Bacteriol. 51:415-424.
23. Graham, A.; I.J. Eustace; and V.H. Powell. 1978. Surface 
decontamination--A new processing unit for improved hygiene on 
carcass meat. Proc. 24th Eur. Meet Meat Res. Work., Kulmbach 1:B8:3-
B8:6.
24. Cain, B.P. and V.H. Powell. 1983. A prototype cabinet for the 
decontamination of beef sides. Meat Research Report 3/83 P. 8. CSIRO 
Division of Food Research, Meat Research Laboratory, Australia.
25. Anderson, M.E.; R.T. Marshall; and W.C. Stringer. 1982. U.S. 
Patent 4,337,549 (6 July).
26. Smith, M.G. 1992. Destruction of bacteria on fresh meat by hot 
water. Epidemol. Infect. 109:491-496.
27. Smith, M.G. and K.R. Davey. 1990. Destruction of E. coli on 
sides of beef by a hot water decontamination process. Food 
Australia. 42(4):195-198.
28. Smith, G.C. et. al. Fecal-material removal and bacterial-count 
reduction by trimming and/or spray-washing of beef external-fat 
surfaces. Submitted for publication to Proceedings of 1994 American 
Meat Industry Conference, San Francisco, CA.
29. Reagan, J.O. et. al. 1995. Trimming and washing of beef 
carcasses as a method of improving the microbiological quality of 
meat. J. Food Prot. (Submitted for publication.)
30. Davey, K.R. and M.G. Smith. 1989. A laboratory evaluation of a 
noval hot water cabinet for the decontamination of sides of beef. 
Int. J. Food Sci. 24:305-316.
31. Barkate, M.L.; G.R. Acuff; L.M. Lucia; and D.S. Hale. 1993. Hot 
water decontamination of beef carcasses for reduction of initial 
bacterial numbers. Meat Science, 35:397-401.
32. Anderson, M.E.; R.T. Marshall; W.C. Stringer; and H.D. Nauman. 
1979. Microbial growth on plate beef during extended storage after 
washing and sanitizing. J. Food Prot. 42:389-392.
33. Kotula, A.W.; W.R. Lusby; J.D. Crouse; and B. de Vries. 1974. 
Beef carcass washing to reduce bacterial contamination. J. Anim. 
Sci. 39:674-679. [[Page 6835]] 
34. Kelly, C.A.; Dempster, J.F. and McLoughlin, A.J. 1981. The 
effect of temperature, pressure and chlorine concentration of spray 
washing water on number of bacteria on lamb carcasses. J. Appl. 
Bacteriol. 51:415-424.
35. Smith, M.G. 1985. The generation time, lag time, and minimum 
temperature of growth of coliform organisms on meat, and the 
implications for codes of practice in abattoirs. J. Hyg. Camb. 
94:289-300.
36. Shaw, M.K.; A.G. Marr; and J.L. Ingraham. 1971. Determination of 
the minimal temperature for growth of Escherichia coli., J. 
Bacteriology. 105:683-684.
37. Mackey, B.M.; T.A. Roberts; J. Mansfield, and G. Farkas. 1980. 
Growth of Salmonella on chilled meat. J. Hyg. 85:115-124.
38. Barkate, M.L.; G.R. Acuff; L.M. Lucia; and D.S. Hale. 1993. Hot 
water decontamination of beef carcasses for reduction of initial 
bacterial numbers. Meat Science, 35:397-401.
39. Bulter, J.L.; J.C. Stewart; C. Vanderzant; Z.L. Carpenter; and 
G.C. Smith. 1979. Attachment of microorganisms to pork skin and 
surfaces of beef and lamb carcasses. J. Food Prot. 42:401-406.
40. Dickson, J.S. 1990. Surface moisture and osmotic stress as 
factors that affect the sanitizing of beef tissue surfaces. J. Food 
Prot. 53:674-679.
41. Greer, G.G. and B.D. Dilts. 1992. Factors affecting the 
susceptibility of meatborne pathogens and spoilage bacteria to 
organic acid. Food Res. Inter. 25:355-364.
42. Dickson, J.S. and M.E. Anderson. 1992. Microbiological 
decontamination of food animal carcasses by washing and sanitizing 
systems: A review. J. Food Prot. Vol. 55:133-140.
43. Ingram, M. and T. A. Roberts. 1976. The Microbiology of the red 
meat carcass and the slaughterhouse. Royal Society of Health 
Journal. 96:270-276.
44. Roberts, T.A. and B. Pharm. 1980. Contamination of meat: The 
effects of slaughter practices on the bacteriology of the red meat 
carcass. Royal Soc. Health J. 100:3-9.
45. Eklund, T. 1983. The antimicrobial effect of dissociated and 
undissociated sorbic acid at different pH levels. J. Appl. Bacteriol 
54:383-389.
46. Baird-Parker, A.C. 1980. Microbial ecology of foods. Factors 
affecting life and death of microorganisms by the International 
Commission on Microbiological Specifications for Foods. Chap. 7. In 
Organic Acids, Vol. 1. Academic Press, New York.
47. Hunter, D.R. and I.H. Segel. 1973. Effect of weak acids on a 
minoacid transport by Penicillium chrysogenum. Evidence for proton 
or change gradient as the driving force. J. of Bacteriology, 
113:1184-1192.
48. Quartey-Papafio, E.A., R.T. Marshall, and M.E. Anderson. 1980. 
Short-chain fatty acids as sanitizers for beef. J. Food Prot. 
43:168-171.
49. Woolthuis, C.H.J., D.A.A. Mossel, J.G.V. Logtestijn, J.M. de 
Kruijf, and F.J.M. Smulders. 1984. Microbial decontamination of 
porcine livers with lactic acid and hot water. J. Food Prot. 48:832-
837.
50. Hamby, P.L., J.W. Savell, G.R. Acuff, C. Vanderzant, and H.R. 
Cross, 1987. Spray-chilling and carcass decontamination systems 
using lactic and acetic acid. Meat Science 21:1-14.
51. Van Der Marel, G.M., J.G. VanLogtestijn, D.A.A. Mossell. 1988. 
Bacteriological quality of broiler carcasses as affected by in-plant 
lactic acid decontamination. Int. J. Food Microbiology. 31:31-42.
52. Prasai, R.K., G.R. Acuff, L.M. Lucia, D.S. Hale, J.W. Savell, 
and J.B. Morgan. 1991. Microbiological effects of acid 
decontamination of beef carcasses at various locations in 
processing. J. Food Prot. 54:868-872.
53. Acuff, G.R., C. Vanderzant, J.W. Savell, D.K. Jones, D.B. 
Griffin, and J.G. Ehlers. 1987. Effect of acid decontamination of 
beef subprimal cuts on the microbiological and sensory 
characteristics of steaks. Meat Sci. 19:217-226.
54. Osthold. W.H., K. Shin, J. Dresel, and L. Leistner. 1984. 
Improving the storage life of carcasses by treating their surfaces 
with an acid spray. Fleischwirtschaft. 64:828-830.
55. Bell, M.F., R.T. Marshall, and M.E. Anderson. 1986. 
Microbiological and sensory test of beef treated with acetic and 
formic acids. J. Food Prot. 49:207-210.
56. Smulders, F.J.M., P. Barendsen, J.G. van Logtestijn, D.A.A. 
Mossel and G.M. van der Marel. 1986. Review: Lactic acid: 
considerations in favor of its acceptance as a meat decontaminant. 
J. Food Technol. 21:419-436.
57. Anderson, M.E., H.E. Huff, H.D. Naumann, R.T. Marshall, J. 
Damare, R. Johnston, and M. Pratt. 1987. Evaluation of Swab and 
Tissue Excision Methods for Recovering Microorganisms from Washed 
and Sanitized Beef Carcasses. J. Food Protection. 50:741-743.
58. Dickson, J.S. 1991. Control of Salmonella typhimurium, Listeria 
monocytogenes and Escherichia coli 0157:H7 on beef in a model spray 
chilling system. J. Food Sci. 56:191-193.
59. Siragusa, G.R. and J.S. Dickson. 1992. Inhibition of Listeria 
monocytogenes on beef tissue by application of organic acid 
immobilized in calcium alginate gel. J. Food Sci. 57:293-296.
60. Cutter, N.C., and G.R. Siragusa. 1994. Efficancy of organic 
acids against Escherichia coli 0157:H7 attached to beef carcass 
tissue using a pilot scale model carcass washer. J. Food Prot. 
57:97-103.
61. Woolthuis, C.H., and F.J.M. Smulders. 1985. Microbial 
decontamination of calf carcasses by lactic acid spray. J. Food 
Prot. 48:832-837.
62. Anderson, M.E. and R.T. Marshall. 1990. Reducing microbial 
populations on beef tissues: Concentration and temperature of lactic 
acid. J. Food Sci. 55:903-905.
63. Anderson, M.E. and R.T. Marshall. 1989. Reducing microbial 
populations on beef tissues: Concentration and temperature of an 
acid mixture. J. Food Safety 10:181-190.
64. Acuff, G.R., J.W. Savell, and M.D. Hardin, 1994. Preliminary 
Results, Comparison of methods for contamination removal from beef 
carcass surfaces. In response to Federal Register Notice, Beef 
carcass trimming versus washing study, Vol 58. No 118, pp. 33925-31.
65. Notermans, S. and M. Van Schotorst.Dickson,. 1977. Die 
Geflugelverarbeiiitung: Ein besonderes Problem der Betriebshygiene. 
Fleischwirtschaft. 57:248-252.
66. Brackett, R.E., Y.Y. Hao, and M.P. Doyle. 1993. Ineffectiveness 
of hot acid sprays to decontaminate Escherichia coli 0157:H7 on 
Beef. J. Food Prot. 57:198-203.
67. Food Safety and Inspection Service Administrator: 10/13/92 Cross 
letter; 2/4/94 Cross letter; 3/29/94 Medley letter.
68. Food Chemical Codes III, 1981, pp. 293-295.
69. Tamblyn, K.C., D.E. Conner, S.F. Bilgili, and G.S. Hill. 1993. 
Utilization of the Skin Attachment Model (SAM) to Determine the 
Antibacterial Activity of Potential Carcass Treatments. Poultry Sci. 
72 supplement (1):298.
70. Dickson, J.A. and A.D. Whittemore. 1993. The effect of dipping 
processed broiler carcasses in a trisodium phosphate solution on 
total aerobes, Enterobacteriaceae, and inoculated Salmonella. 
Poultry Sci. 72 supplement (1):S35.
71. Lillard, H.S. 1994. Effect of trisodium phosphate on Salmonella 
attached to chicken skin. J. Food Prot. 57:465-469.
72. Rhone-Poulenc pre-chill petition (HC015), January 13, 1994.
73. ABC Research Laboratories, Gainsville, FL.
74. Gorseline H. 1951. In-plant chlorine does a 3-way job. U.S. Egg 
and Plant Magazine. April. Pp. 12, 13, 29-31.
75. USDA, FSIS, January 1, 1994. List of Proprietary Substances and 
Nonfood Compounds, Miscellaneous Publication No. 1419. Page II-vi.
76. James, W.O., R.L. Brewer, J.C. Prucha, W.O. Williams, and D.P. 
Parham. 1992. Effect of chlorination of chill water on the 
bacteriologic profile of raw chicken carcasses and giblets. 
J.A.V.M.A. 200:60-63.
77. Drewniak, E.E., M.A. Howe, Jr., H.E. Goresline and E.R. Baush. 
1954. Studies on sanitizing methods for use in poultry processing. 
U.S.D.A. Circular No. 930.
78. Ranken, M.D., G. Clewlow, D.H. Shrimpton, and B.J. H. Stevens. 
1965. Chlorine in poultry processing. Brit. Poult. Sci. 6:331-      
.
79. Patterson, J.T. 1968. Chlorination of water used for poultry 
processing. Brit. Poul. Sci 9:129-      .
80. Lillard, H.A. 1979. Levels of chlorine dioxide of equivalent 
bactericidal effect in poultry processing water. J. Food Sci. 
44:1594-1597. [[Page 6836]] 
81. Patterson, J.T. 1968. Hygiene in meat processing plants. 3. 
Methods of reducing carcass contamination. Record of Agr. Res. 
Ministry of Agriculture North Ireland. 17:7.
82. Bailey, C. 1971. Spray washing of lamb carcasses. pp. 175-181. 
In Proceeding of 17th European Meeting of Meat Research Workers. 
Bristol, England.
83. Stringer, W.C., M.E. Bilskie, and H.D. Naumann. 1969. Microbial 
proviles of fresh beef. Food Technol. 23:97-    .
84. Marshall, R.T., M.E. Anderson, H.D. Naumann, and W.G. Stringer. 
1977. Experiments in sanitizing beef with sodium hypochlorite. J. 
Food Prot. 40:246-249.
85. Anderson, M.E., R.T. Marshall, W.C. Stringer, and H.D. Nauman. 
1977. Efficacies of three sanitizers under six conditions of 
application to the surface of beef. J. Food Sci. 42:326-329.
86. Documentation supporting the prior sanction finding is available 
for review in the FSIS Docket Clerk's office.
87. Morris R.D., A.M. Audet, I.F. Angelillo, et al. 1992. 
Chlorination, chloriantion by-products, and cancer: a meta-analysis. 
Am. J. Public Health 82 (7): 955-63.
88. ENVIRON Corporation, Arlington, Virginia. 1994. A risk 
assessment to evaluate the potential human health effects from the 
presence of chloroform in chicken fat and skin. Prepared for FSIS, 
USDA.
89. Gill, C.O. and C. McGinnis. 1993. Changes in the microflora on 
commercial beef trimmings during their collection, distribution and 
preparation for retail sale as ground beef. Int. J. Food 
Microbiology. 18:321-332.
90. Ingham, S.C., R.A. Alford and P. McCown. 1990. Comparative 
growth rates of Salmonella typhimurium and Pseudomonas fragi on 
cooked crab meat stored under air and modified atmosphere. J. Food 
Prot. 53:566-567, 625.
91. Lee, C.Y., D.Y.C. Fung and C.L. Kastner. 1985. Computer-assisted 
identification on microflora on hot-boned and conventionally 
processed beef: effect of moderate and slow chilling rate. J. Food 
Sci. 50:553-567.
92. Ray, B., C. Johnson and A. Field. 1984. Growth of indicator, 
pathogenic and psychrotrophic bacteria in mechanically separated 
beef, lean ground beef and beef bone marrow. J. Food Prot. 47:672-
677.
93. Smith, M.G. 1985. The generation time, lag time and minimum 
temperature of growth of coliform organisms on meat and the 
implications for codes of practice in abattoirs. J. Hygiene Camb. 
94:289-300.
94. Smith, M.G. 1987. Calculation of the expected increases of 
coliform organisms, Escherichia coli and Salmonella typhimurium, in 
raw blended mutton tissue. Epidemiology Infection. 99:323-331.
95. Mattila-Sandholm, T., and E. Skytta. 1991. The effect of 
spoilage flora on the growth of food pathogens in minced meat stored 
at chilled temperature. Lebensm. Wiss. u. Technol. 24:110-120.
96. Mattila-Sandholm, T., A. Haikara and E. Skytta. 1991. The effect 
of Pediococcus damnosus and Pediococcus pentosaceus on the growth of 
pathogens in minced meat. International J. Food Micr. 13:87-94.
97. Skytta, E., W. Hereijgers and T. Mattila-Sandholm. 1991. Broad 
spectrum antibacterial activity of Pediococcus damnosus and 
Pediococcus pentosaceus in minced meat. Food Microbiology. 8:231-
237.
98. Vanderzant, C. and C.S. Custer. 1968. Interactive inhibitory 
activities among certain psychrotrophic bacteria from dairy foods. 
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 
and removal of Salmonella spp. on meat and poultry tissues. J. Food 
Safety 11:135-148.
5. Buchanan, R.L., Stahl, H.G., and Archer, D.L. 1987. Improved 
plating media for simplified, quantitative detection of Listeria 
monocytogenes in foods. Food Microbiol. 4:269-275.
6. Buchanan, R.L. and Klawitter, L.A. 1991. Effect of temperature 
history on the growth of Listeria monocytogenes Scott A at 
refrigeration temperatures. Int. J. Food Microbiol. 12:235-246.
7. Buchanan, R.L. and Klawitter, L.A. 1992a. Characterization of a 
lactic acid bacterium, Carnobacterium piscicola LK5, with activity 
against Listeria monocytogenes at refrigeration temperatures. J. 
Food Safety 12:199-217. [[Page 6855]] 
8. Buchanan, R.L. and Klawitter, L.A. 1992b. Effectiveness of 
Carnobacterium piscicola LK5 for controlling the growth of Listeria 
monocytogenes Scott A in refrigerated foods. J. Food Safety 12:219-
236.
9. Buchanan, R.L. and Klawitter, L.K. 1992c. The effect of 
incubation temperature, initial pH, and sodium chloride on the 
growth kinetics of Escherichia coli 0157:H7. Food Microbiol. 9:185-
196.
10. Dickson, J.S. 1990. Survival and growth of Listeria 
monocytogenes on beef tissue surfaces as affected by simulated 
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-
2396.
11. Felsenfeld, O., Young, V.M. and Yoshimura, T. 1950. A survey of 
Salmonella organisms in market meat, eggs, and milk. J. Amer. Vet. 
Med. Assoc. 116:17-21.
12. Genigeorgis, C.A. 1985. Microbial and safety implications of the 
use of modified atmospheres to extend the storage life of fresh meat 
and fish. Int. J. Food Microbiol. 1:237-251.
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 
Listeria monocytogenes on high-pH beef packaged under vacuum or 
carbon dioxide. Food Microbiol. 6:223-230.
15. Gilliland, S.E. and Speck, M.L. 1977. Antagonistic action of 
Lactobacillus acidophilus toward intestinal and foodborne pathogens 
in associative cultures. J. Food Protection 40:820-823.
16. Glass, K.A. and Doyle. M.P. 1989. Fate of Listeria monocytogenes 
in processed meat products during refrigerated storage. Appl. 
Environ. Microbiol. 55:1565-1569.
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 
chloride and in fermented, dry sausage. Appl. Environ. Microbiol. 
58:2513-2516.
18. Goo, V.Y.L., Ching, G.Q.L. and Gooch, J.M. 1973. Comparison of 
brilliant green agar and Hektoen enteric agar media in the isolation 
of salmonellae from food products. Appl. Microbiol. 26:288-292.
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 
monocytogenes on vacuum-packaged beef. J. Food Protection 53:739-
741, 746.
21. Hintlian, C.B. and Hotchkiss, J.H. 1986. The safety of modified 
atmosphere packaging: a review. Food Technol. 40(12):70-76.
22. Hughes, A.H. and McDermott, J.C. 1989. The effect of phosphate, 
sodium chloride, sodium nitrite, storage temperature and pH on the 
growth of enteropathogenic Escherichia coli in a laboratory medium. 
Int. J. Food Microbiol. 9:215-223. '
23. Ingram, S. C., Escude, J. M., and McCown, P. 1990. Comparative 
growth rates of Listeria monocytogenes and Pseudomonas fragi on 
cooked chicken loaf stored under air and two modified atmospheres. 
J. Food Protection 53:289-291.
24. Johnson, J.L., Doyle, M.P., Cassens, R.G. and Schoeni, J.L. 
1988a. Fate of Listeria monocytogenes in tissues of experimentally 
infected cattle and in hard salami. Appl. Environ. Microbiol. 
54:497-501.
25. Johnson, J.L., Doyle, M.P. and Cassens, R.G. 1988b. Survival of 
Listeria monocytogenes in ground beef. Int. J. Food Microbiol. 
6:243-247.
26. Johnston, R.W. and R.B. Tompkin. 1992. Meat and poultry 
products. In: ``Compendium of Methods for the Microbiological 
Examination of Foods. 3rd Ed. C. Vanderzant and D.F. Splittstoesser, 
eds. Washington, D.C., American Public Health Association.
27. Kaya, M. and Schmidt, U. 1989. Verhlaten von Listeria 
monocytogenes im Hackfleisch bei Kuhl- und Gefrierlagerung. 
Fleischwirtschaft 69:617-620.
28. Kaya, M. and Schmidt, U. 1991. Behavior of Listeria 
monocytogenes on vacuum-packed beef. Fleischwirtschaft 71:424-426.
29. Khan, M.A., Palmas, C.V., Seaman, A. and Woodbine, M. 1972. 
Survival versus growth of a facultative psychrotroph. Acta 
Microbiol. Acad. Sci. Hung. 19:357-362.
30. Khan, M.A., Palmas, C.V., Seaman, A. and Woodbine, M. 1973. 
Survival versus growth of a facultative psychrotroph: Meat and 
products of meat. Zbl. Bakteriol. Hyg. Abt. Orig. B. 157:277-282.
31. Lewus, C.B., Kaiser, A. and Montville, T.J. 1991. Inhibition of 
food-borne bacterial pathogens by bacteriocins from lactic acid 
bacteria isolated from meat. Appl. Environ. Microbiol. 57:1683-1688.
32. Mackey, B.M., Roberts, T.A., Mansfield, J. and Farkas, G. 1980. 
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 
temperature and inoculum size on growth of salmonellae in minced 
beef. Int. J. Food Microbiol. 6:57-65.
34. Mattila-Sandholm, T. and Skytta, E. 1991. The effect of spoilage 
flora on the growth of food pathogens in minced meat stored at 
chilled temperature. Lebensm. Wiss. U.-Technol. 24:116-120.
35. Mortvedt, C.I. and Nes, I.F. 1990. Plasmid-associated 
bacteriocin production by a Lactobacillus sake strain. J. Gen. 
Microbiol. 136:1601-1607.
36. Nazer, A.H.K. and Osborne, A.D. 1976. Salmonella infection and 
contamination of veal calves: a slaughterhouse survey. Brit. Vet. J. 
132:192-201.
37. Palumbo, S.A., Bencivengo, M.M., Del Corral, F., Williams, A.C. 
and Buchanan, R.L. 1989. Characterization of the Aeromonas 
hydrophila group isolated from retail foods of animal origin. J. 
Clin. Microbiol. 27:854-859.
38. Ryser, E.T. and Marth, E.H. 1991. ``Listeria, Listeriosis, and 
Food Safety.'' Marcel Dekker, Inc. New York. pp.405-462.
39. Sanderson, K., Thomas, C.J. and McMeekin, T.A. 1991. Molecular 
basis of the adhesion of Salmonella serotypes to chicken muscle 
fascia. Biofouling 5:89-101.
40. Schillinger, U. and Lucke, F.K. 1989. Antibacterial activity of 
Lactobacillus sake isolated from meat. Appl. Environ. Microbiol. 
55:1901-1906.
41. Shelef, L.A. 1989. Survival of Listeria monocytogenes in ground 
beef or liver during storage at 4 and 25 deg.C. J. Food Protection 
52:379-383.
42. Smith, M.G. 1985. The generation time, lag time, and minimum 
temperature of growth of coliform organisms on meat, and the 
implications for codes of practice in abattoirs. J. Hyg., Camb. 
94:289-300.
43. Smith, M.G. 1987. Calculation of the expected increases of 
coliform organisms, Escherichia coli and Salmonella typhimurium, in 
raw blended mutton tissue. Epidem. Inf. 99:323-331.
44. Stolle, A. 1981. Spreading of salmonellas during cattle 
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 
beef. Int. J. Food Microbiol. 6:269-280. Wells, J.G., Shipman, L.D., 
Greene, K.D., Sowers, E.G., Green,
47. 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.
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. 
Saunders Co., Philadelphia. Vol. 4, No. 3:441-480.
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.                                                                               
--------------------------------------------------------------------------------------------------------------------------------------------------------


[[Page 6863]]

[GRAPHIC][TIFF OMITTED]TP03FE95.003


[[Page 6864]]

[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.

                                                                                                                
[[Page 6886]]                                                                                                   
                           Table 6.--Degree of Difficulty for Developing a HACCP Plan                           
----------------------------------------------------------------------------------------------------------------
  Plan No.                                   HACCP process                                  Degree of difficulty
----------------------------------------------------------------------------------------------------------------
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.               
----------------------------------------------------------------------------------------------------------------


                                                 BILLING CODE 3410-DM-P
[[Page 6887]]

[GRAPHIC][TIFF OMITTED]TP03FE95.006


[[Page 6888]]

[GRAPHIC][TIFF OMITTED]TP03FE95.007


[[Page 6889]]

[GRAPHIC][TIFF OMITTED]TP03FE95.008



[FR Doc. 95-2366 Filed 1-31-95; 8:45 am]
BILLING CODE 3410-DM-C