Pathogen Reduction; Hazard Analysis and Critical Control Point (HACCP) Systems

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

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[GRAPHIC][TIFF OMITTED]TP03FE95.000

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[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)(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 (10/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 un

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