12590 Federal Register / Vol. 66, No. 39 / Tuesday, February 27, 2001 / Proposed Rules

DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Parts 301, 303, 317, 318, 319,

320, 325, 331, 381, 417, and 430

[Docket No. 97–013P]

RIN No. 0583–AC46

Performance Standards for the

Production of Processed Meat and

Poultry Products

AGENCY: Food Safety and Inspection

Service, Agriculture.

ACTION: Proposed rule.

SUMMARY: The Food Safety and

Inspection Service (FSIS) is proposing

to amend the Federal meat and poultry

inspection regulations by establishing

food safety performance standards for

all ready-to-eat (RTE) and all partially

heat-treated meat and poultry products.

The proposed performance standards set

forth levels of pathogen reduction and

limits on pathogen growth that official

meat and poultry establishments must

achieve in order to produce

unadulterated products, but allow the

use of customized, plant-specific

processing procedures. The proposed

RTE performance standards apply to all

RTE meat and poultry products, which

can be categorized as follows: Dried

products (e.g., beef or poultry jerky);

salt-cured products (e.g. country ham);

fermented products (e.g., salami and

Lebanon bologna); cooked and

otherwise processed products (e.g., beef

and chicken burritos, corned beef,

pastrami, poultry rolls, and turkey

franks); and thermally-processed,

commercially sterile products (e.g.,

canned spaghetti with meat balls and

canned corned beef hash).

Although FSIS routinely samples and

tests some RTE products for the

presence of pathogens prior to

distribution, there are no specific

regulatory pathogen reduction

requirements for most of these products.

The proposed performance standards

will help ensure the safety of these

products; give establishments the

incentive and flexibility to adopt

innovative, science-based food safety

processing procedures and controls; and

provide objective, measurable standards

that can be verified by Agency

oversight.

FSIS also is proposing environmental

testing requirements intended to reduce

the incidence of Listeria monocytogenes

in RTE meat and poultry products.

Specifically, FSIS is proposing to

require establishments that produce

RTE meat and poultry products to test

food contact surfaces for Listeria spp. to

verify that they are controlling the

presence of L. monocytogenes within

their processing environments.

Establishments that have developed and

implemented HACCP controls for L.

monocytogenes would be exempt from

these testing requirements.

Finally, FSIS is proposing to

eliminate its regulations that require

that both RTE and not-ready-to eat pork

and products containing pork be treated

to destroy trichina (Trichinella spiralis).

These requirements are inconsistent

with HACCP and some will be

unnecessary if FSIS makes final the

proposed performance standards for

RTE meat and poultry products.

DATES: Comments must be received on

or before May 29, 2001.

ADDRESSES: Submit one original and

two copies of written comments to FSIS

Docket #97–013P, U.S. Department of

Agriculture, Food Safety and Inspection

Service, Room 102, Cotton Annex, 300

12 St., SW., Washington, DC 20250–

3700. All comments submitted in

response to this notice will be available

for public inspection in the Docket

Clerk’s Office between 8:30 a.m. and

4:30 p.m., Monday through Friday.

FOR FURTHER INFORMATION CONTACT:

Daniel L. Engeljohn, Ph.D., Director,

Regulation Development and Analysis

Division, Office of Policy, Program

Development, and Evaluation, Food

Safety and Inspection Service, U.S.

Department of Agriculture (202) 720–

5627.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Background

II. RTE Meat and Poultry Products

III. Performance Standards and HACCP

IV. The Proposed Performance Standards

A. Lethality

Compliance with the Proposed Lethality

Performance Standards

Derivation of the Proposed Lethality

Performance Standards

Selection of the Reference Organisms

Dried Products

Salt-cured Products

Fermented Products

Cooked and otherwise Processed Whole or

Comminuted Meat Products

Meat Patties

Cooked and otherwise Processed Whole or

Comminuted Poultry Products

B. Stabilization

V. Listeria monocytogenes

A. Proposed Requirements for Controlling

L. monocytogenes

B. Shelf-life and Labeling

VI. Thermally Processed, Commercially

Sterile Products

A. Lethality

B. Commercial Sterility

C. Training

VII. Elimination of Trichina Treatment

Requirements

VIII. Other Proposed Revisions to the

Regulations

IX. Scientific Information and Data Needs

X. Summary of the Proposed Rule

XI. Compliance with Executive Order 12866

XII. Compliance with the Regulatory

Flexibility Act

XIII. Executive Order 12988

XIV. Risk Analysis

XV. Additional Public Notification

XVI. Paperwork Requirements

XVII. References

XVIII. Proposed Regulations

Appendix 1

I. Background

Under the Federal Meat Inspection

Act (FMIA; 21 U.S.C. 601 et seq.) and

the Poultry Products Inspection Act

(PPIA; 21 U.S.C. 451 et seq.), FSIS

issues regulations governing the

production of meat and poultry

products prepared for distribution in

commerce. The regulations, along with

FSIS inspection programs, are designed

to ensure that meat and poultry

products are safe, wholesome,

unadulterated, and properly marked,

labeled, and packaged. In this

document, FSIS is proposing to

establish new pathogen reduction

regulations for ready-to-eat (RTE) and

partially heat-treated meat and poultry

products. This proposed action is

compelled by recent outbreaks of

foodborne illness related to the

consumption of adulterated RTE meat

and poultry products, as well as the

need to provide objective, measurable

pathogen reduction standards that can

be met by official establishments and

compliance with which can be

determined through Agency inspection.

II. RTE Meat and Poultry Products

RTE meat and poultry products are

products that have been processed so

that they may be safely consumed

without further preparation by the

consumer, i.e., without cooking or

application of some other lethality

treatment to destroy pathogens.

Although many of these products, such

as frozen pizzas or country hams,

customarily are cooked or otherwise

reprocessed by the consumer, they

would be safe to eat, if unpalatable,

without this further preparation.

RTE meat and poultry products can be

either non-shelf-stable or shelf-stable.

Non-shelf-stable, RTE products must be

refrigerated until consumption to

prevent the growth of both pathogenic

and spoilage organisms. Shelf-stable

products remain ready-to-eat under

ordinary temperature and humidity

conditions and, if the package integrity

is maintained during holding, shipping,

Federal Register / Vol. 66, No. 39 / Tuesday, February 27, 2001 / Proposed Rules 12591

storage, display at retail, and in the

home, throughout the manufacturer’s

shelf-life determination. Throughout the

shelf-life, shelf-stable products are safe

to eat when unrefrigerated (at

temperatures over 50 °F or 10 °C)

without additional preparation.

Thermally processed, commercially

sterile meat and poultry products are

packaged in hermetically sealed

containers (usually cans) and also

remain shelf-stable under unrefrigerated

conditions (over 50 °F or 10 °C).

For the purposes of this proposal,

FSIS has divided ready-to-eat meat and

poultry products into five categories,

based on the type of processing they

receive: dried products; salt-cured

products; fermented products; cooked or

otherwise processed whole and

comminuted products; and thermallyprocessed, commercially sterile

products. Many of these products can be

either shelf-stable or non-shelf-stable.

EXAMPLES OF RTE PRODUCTS

Dried Products .......................................................................................... Basturma, Pastirma, Basturmi.

Beef Sticks.

Carne Seca.

Dried Beef.

Dry Duck Breast.

Meat/Poultry Jerky.

Salt-Cured Products ................................................................................. Cappicola.

Coppa.

Country Ham.

Dry Cured Duck.

Parma Ham.

Prosciutto, Prosciutti.

Fermented Products ................................................................................. Alessandri (Dry Sausage).

Apenino (Dry Sausage).

Arles or D’Arles (Dry Sausage).

Blockwurst (Semi-Dry Sausage).

Cacciatore/Cacciatora (Dry Sausage).

Cervelat.

Cervelat, Soft.

Chorizo.

Lebanon Bologna.

Pepperoni.

Salami, Soft.

Salami: Genoa, Italian, German.

Summer Sausage.

Thuringer.

Thuringer, Soft.

Cooked or Otherwise Processed Whole or Comminuted Products ......... Meat

Berliner (Cooked, Smoked Sausage).

Bologna.

Bratwurst, Cooked.

Braunschweiger/Liver Sausage.

Breakfast Link Sausage or Patties.

Brown and Serve Sausage.

Burritos.

Cheese Smokies.

Cheesefurter.

Cheesewurst/Cheddarwurst.

Chili.

Chorizo.

Cooked Beef.

Cooked Ham.

Cooked Pork in BBQ Sauce.

Cotto Salami.

Entrees/Dinners.

Fleischkaese (Cured, Cooked Sausage).

Frankfurters.

Frozen Entrees/Dinners.

Gyros.

Meat Loaf.

Meat Salads.

Meat Soups, Frozen.

Nem-Chua (Cooked, Pickled Ham with Shredded Pork Skin).

Pasta with Meat Sauce.

Pastrami.

Pickled Pigs Feet in Vinegar.

Pickled Sausages/Meat in Vinegar.

Piroshki.

Pork Barbecue.

Pork Sausage Patties.

Ravioli.

Roast Beef.

Roast Pork.

Souse.

12592 Federal Register / Vol. 66, No. 39 / Tuesday, February 27, 2001 / Proposed Rules

EXAMPLES OF RTE PRODUCTS—Continued

Stews.

White Hots.

Wieners.

Poultry (Includes Products Containing any Amount of Poultry).

Chicken Burritos.

Chicken BBQ.

Chicken Bologna.

Chicken Breast.

Chicken Franks.

Cooked Poultry.

Cooked Poultry Rolls.

Corn Chowder with Chicken.

Entrees/Dinners.

Poultry Loaf.

Poultry Patties.

Poultry Rolls.

Poultry Salads.

Poultry Soups, Frozen.

Turkey BBQ.

Turkey Franks.

Thermally-Processed, Commercially Sterile Products ............................. Canned Spaghetti with Meat Balls.

Canned Corned Beef Hash.

Canned Ham.

Canned Chicken Salad.

Canned Soups with Meat or Poultry.

FSIS is proposing to require that the

processing of each of these types of

products achieve specific levels of

pathogen reduction, as well as control

over the growth of target pathogens so

that they do not exceed specific levels.

These levels are the performance

standards. Establishments also would be

required to maintain these levels of

pathogen reduction and pathogen

growth in their products, under normal

handling conditions, until their

products reach the consumer.

FSIS already has established pathogen

reduction performance standards

specific to certain types of not-shelfstable, RTE meat and poultry products.

On January 6, 1999, FSIS published a

final rule in the Federal Register (FSIS

Docket No. 95–033F; 64 FR 732) that

established performance standards for

RTE roast beef, corned beef, and cooked

beef, all ‘‘fully-cooked’’ RTE poultry

products, and partially-cooked meat

patty and poultry products. Those

standards are consistent with and, in

fact, incorporated into the more

comprehensive group of standards

proposed in this document.

III. Performance Standards and HACCP

Under the regulations in 9 CFR 417,

FSIS requires each official meat and

poultry establishment to develop and

implement a Hazard Analysis and

Critical Control Point (HACCP) system,

a science-based process control system

for food safety that promotes systematic

prevention of biological, chemical, and

physical hazards. Establishments are

responsible for developing and

implementing HACCP plans that

incorporate the controls necessary and

appropriate to produce safe meat and

poultry products. HACCP is a flexible

system that enables establishments to

tailor their control systems to the needs

of their particular plants and processes.

Performance standards can be usefully

and seamlessly incorporated into

HACCP systems.

When developing a HACCP plan, an

establishment must conduct a hazard

analysis to identify and list the physical,

biological, or chemical food safety

hazards reasonably likely to occur in the

production process for a particular

product and the preventive measures

necessary to control those hazards. The

establishment then must identify the

critical control points (CCPs) in each of

its processes. A CCP is a point, step, or

procedure in a food process at which

control can be applied to ensure that the

occurrence of a food safety hazard is

prevented, eliminated, or reduced to an

acceptable level. Next, the

establishment must establish critical

limits for the preventive measures

associated with each identified CCP. A

critical limit is the maximum or

minimum value to which a hazard must

be controlled at a CCP to prevent,

eliminate, or reduce to an acceptable

level the occurrence of the identified

food safety hazard. Critical limits are

most often based on process parameters

such as temperature, time, water

activity, pH, or humidity. Significantly,

critical limits must be designed to

satisfy relevant FSIS regulations,

including performance standards.

Therefore, performance standards are

an integral part of the HACCP systems

in official meat and poultry

establishments. HACCP provides the

framework for industry to set up

science-based process controls.

Performance standards tell

establishments what those controls need

to achieve for their HACCP plans to be

effective and provide a necessary

measure of accountability for achieving

acceptable food safety. Performance

standards and HACCP provide meat and

poultry establishments with the

incentive and flexibility to adopt

innovative, science-based processing

procedures and controls; ensure safety

for consumers; and provide objective,

measurable standards, compliance with

which can be determined through

Agency inspection.

IV. The Proposed Performance

Standards

A. Lethality

For each category of RTE product,

FSIS is proposing at least one lethality

performance standard. The term

‘‘lethality’’ refers to a required reduction

in the number of specific pathogenic

organisms. Further, FSIS is proposing

lethality performance standards that

reflect the destruction of ‘‘reference’’

organisms, i.e., microorganisms whose

elimination or reduction most often

indicates the elimination or necessary

reduction of other pathogens of concern.

In this proposed rule, for all RTE

products except thermally-processed,

commercially sterile products, the

lethality performance standards are

Federal Register / Vol. 66, No. 39 / Tuesday, February 27, 2001 / Proposed Rules 12593

expressed as probabilities of remaining

numbers of the reference pathogen in

100 grams of finished product after a

successful lethality treatment is, or

treatments are, applied to hypothetical

‘‘worst case’’ raw product. The lethality

performance standards also are

expressed as the number of decimal

reductions of the reference pathogen

required to achieve those probabilities

in hypothetical worst case products.

These decimal reductions are expressed

as ‘‘x-log10’’, meaning that the expected

relative reduction of the reference

organism would be a factor of 10x. FSIS

has tentatively concluded that effecting

these specific reductions ensure even a

worst case product would present no

health risk to consumers.

For all RTE meat and poultry

products, other than thermally

processed, commercially sterile

products, FSIS is proposing to require

that processing achieve one of the

following probabilities that that no more

than small numbers of Salmonella

would remain in any 100 gram sample

of a finished product made from worst

case product:

>0 surviving >1 surviving >2 surviving >3 surviving >4 surviving

39.4 9.06 1.45 0.177 0.0174

Although an establishment’s

processing would be required to achieve

these probabilities that there will be

few, if any, remaining pathogens in

finished product, any detectable levels

of viable Salmonella in RTE product

would render that product adulterated.

Alternatively, official establishments

may employ processes validated to

achieve specific levels of reduction of

Salmonella organisms throughout their

finished, RTE meat and poultry

products: 6.5-log10 throughout finished,

RTE meat products and 7-log10

throughout finished, RTE products

containing any amount of poultry. The

probabilities in Table 1 are derived from

statistical models of hypothetical worst

case meat and poultry products that

have been successfully processed to

achieve 6.5-log10 and 7-log10 reductions

in Salmonella, respectively. A

hypothetical, worst case raw meat

product would contain 6.2-log10 of

Salmonella per hundred grams; a

hypothetical, worst case raw poultry

product would contain 6.7-log10 of

Salmonella per hundred grams. See the

section entitled ‘‘Derivation of the

Proposed Lethality Performance

Standards’’ for further discussion.

The Agency has selected Salmonella

as the reference organism for most RTE

meat and poultry products because: (1)

It is prevalent in raw poultry, beef, and

pork; (2) it causes a high incidence of

foodborne illness; and (3) foodborne

illness associated with Salmonella is

severe. See the section entitled

‘‘Selection of the Reference Organisms’’

for additional discussion of how FSIS

determined the lethality performance

standards and the target pathogen for

each type of RTE meat and poultry

product.

Because destruction of reference

organisms may not always result in the

elimination or necessary reduction of

other pathogens of concern, FSIS also is

proposing to clarify in the regulations

that establishments must also reduce

other pathogens and their toxins or toxic

metabolites to the levels necessary to

prevent product adulteration. It is the

responsibility of the establishment to

ensure that the final product is safe. If

FSIS were to find certain viable

pathogens in a RTE product at levels

considered dangerous, even in product

otherwise free of the reference pathogen,

it would consider that product to be

adulterated.

FSIS is not proposing any specific

lethality performance standards in

addition to those that target the

reference pathogen, Salmonella, except

for fermented RTE products that contain

beef. Within its hazard analysis, each

establishment will be responsible for

determining which other pathogens

might survive processing and then

implementing the appropriate control

measures. FSIS requests comment on

whether it should enumerate, in its

regulations, lethality performance

standards for other pathogens and

toxins that can pose hazards to specific

products or within specific processing

contexts.

FSIS is proposing an additional

lethality performance standard for all

fermented RTE products that include

any amount of beef, except thermallyprocessed, commercially sterile

products. The Agency is proposing to

require that establishments that produce

these products implement processes

that result in the following probabilities

that, at worst, only minute amounts of

E. coli O157:H7 organisms would

remain in any 100 gram sample of a

finished product made from worst case

product:

TABLE 2.—PROBABILITY (%) OF E.

COLI O157:H7 SURVIVING IN 100

GRAMS OF FINISHED PRODUCT

MADE FROM WORST CASE PRODUCT

>0 surviving >1 surviving

22.2 2.67

Although an establishment’s

processing would be required to achieve

these probabilities of remaining

pathogens in finished product, any

detectable levels of viable E. coli

O157:H7 in RTE product would render

that product adulterated.

FSIS also is proposing that,

alternatively, establishments may

employ processes validated to achieve a

5.0-log10 reduction of E. coli O157:H7

throughout fermented products

containing beef. The probabilities in

Table 2 are derived from statistical

models applied to hypothetical worst

case beef products that have been

processed to achieve a 5-log10 relative

reduction in E. coli O157:H7. A

hypothetical, worst case raw product

that contained any amount of beef

would contain 4.4-log10 of E. coli

O157:H7 per hundred grams. See the

section entitled ‘‘Derivation of the

Proposed Lethality Performance

Standards’’ for further discussion.

The Agency is proposing this lethality

performance standard in addition to the

Salmonella standard for fermented

products that contain beef for several

reasons. In 1994, there was an outbreak

of foodborne illness linked to E. coli

O157:H7 in fermented beef sausages.

Also, these products may not be fully

cooked before fermentation and

fermentation creates an acidic

environment in which E. coli O157:H7

can survive.

Also, the FSIS Office of Public Health

and Science (OPHS) recently sponsored

a study entitled ‘‘Risk Assessment of the

Public Health Impact of Escherichia coli

O157:H7 in Ground Beef’’ (Ref. 1,

available for viewing by the public in

the FSIS Docket Room). The draft risk

assessment shows that levels of E. coli

O157:H7 in cattle represents a risk to

consumers of ground beef and that

unless there is a significant intervention

on the farm or during processing, the

risk is likely to remain. This draft risk

assessment is discussed further under

the sections entitled ‘‘Derivation of the

12594 Federal Register / Vol. 66, No. 39 / Tuesday, February 27, 2001 / Proposed Rules

1http://www.fsis.usda.gov /OPPDE/rdad/FRPubs/

95– 033F_tech%20paper.pdf

Proposed Lethality Performance

Standards’’ and ‘‘Fermented Products.’’

Cattle and sheep may carry E. coli

O157:H7 in the intestinal tract at the

time of slaughter. However, among

commercially-prepared meat products,

only those that contain beef have been

implicated in a number of foodborne

illnesses associated with this pathogen.

Therefore, in regard to meat and poultry

products, the Agency is proposing this

standard only for fermented products

that contain beef.

FSIS is not proposing this

performance standard for fermented

poultry products that do not contain

beef. E. coli O157:H7 has been found to

colonize the ceca of chickens and has

been isolated from retail poultry in the

United States (Ref. 2, available for

viewing by the public in the FSIS

Docket Room). However, FSIS has never

found the pathogen in raw or ready-tocook samples of poultry obtained from

processing establishments. FSIS

requests comment as to whether it

should also apply this standard to RTE

fermented poultry products that do not

contain beef, as well as to RTE

fermented meat products that do not

contain beef.

FSIS is proposing performance

standards for thermally-processed,

commercially sterile meat and poultry

products that are similar to these

lethality standards but derived

somewhat differently. See the section

‘‘Thermally-Processed Commercially

Sterile Products’’ for a complete

discussion.

Compliance With the Lethality

Performance Standards

To meet the proposed lethality

performance standards, establishments

would need to employ processes

validated either to achieve the proposed

decimal reductions of pathogens

throughout a finished product or that

result in one of the stated probabilities

that only small numbers of reference

organisms would remain viable in a

worst case finished product. To develop

criteria for evaluating the effectiveness

of processes that achieve one of the

proposed probabilities, it will be

necessary for the processor to define,

using associated statistical criteria, the

expected characteristics of the treated

product after processing, assuming

certain product conditions before

processing. For example, an

establishment would need to specify

that the probability of there being more

than x surviving organisms in the

finished product is no more than p,

given that the worst case pre-processed

product contained at least y organisms.

By codifying acceptable probabilities

of remaining reference organisms in

finished product, FSIS would be

allowing establishments to employ

processes that achieve varying levels of

lethality, therefore providing processing

flexibility while ensuring product

safety. By also proposing specific

lethality performance standards in the

regulations, FSIS provides clear

performance standards to

establishments that may not have the

resources to derive an alternative

lethality or the ability to demonstrate

that their process achieves a specific

probability that no more than a certain

number of reference organisms might

exist in the finished product.

As explained above, FSIS has

tentatively determined that processes

that achieve the proposed lethality

performance standards will process

hypothetical, worst case raw product

into finished, RTE product that poses no

health risk to the consumer and is thus

safe. In reaching this tentative

conclusion, the Agency made

conservative assumptions concerning

the actual lethality achieved throughout

the product. The Agency acknowledges

that it might be possible for producers

to demonstrate scientifically that these

lethality assumptions or the Agency’s

defined worst case would not be

applicable for their particular

processing situation. An establishment

could then design a process with

lethality values that are different from

those provided in this rule, but that

would still yield a product that meets

the final conditions equivalent to those

achieved by the specific levels of

pathogen reduction contained in the

lethality performance standards.

An establishment developing an

alternative lethality treatment or

treatments and assuming an initial

product condition other than the worst

case would need to include in its

HACCP plan scientific data and

statistical validation that would justify

the assumed initial conditions and

verify that these would remain constant

over time. For example, an

establishment may be able to

demonstrate that the number of

Salmonella is not uniformly distributed

throughout a particular type of product.

The establishment also might

demonstrate that because of husbandry

and slaughter practices, the worst case

product processed within an

establishment differs from the worst

case scenarios developed for this rule.

Demonstrations of initial product

conditions solely by statistical means

would likely be insufficient to ensure

that processes that employ alternative

lethalities will result in product that

meets the performance standards.

Generally, an establishment will need

to demonstrate in its HACCP plan how

its lethality treatment results in a

finished product equivalent to that

provided by compliance with the

probabilities set out in this proposal.

The establishment will need to

demonstrate the relationships between

the lethality treatments and the specific

characteristics of a product, such as

physical and chemical properties. This

demonstration could involve the use of

heat transfer equations and should

account for all variables that would

affect lethality (e.g., size of product,

humidity, density, thermal

conductivity, specific heat, shape,

product composition, and strain of

organism).

Finally, establishments employing

alternative lethalities will need to

demonstrate, within their HACCP plans,

that they have validated their processes

as being effective in ensuring product

safety. Section 417.4(a)(1) of the HACCP

regulations sets forth the ‘‘initial

validation’’ requirements for

establishments under HACCP:

Upon completion of the hazard analysis

and development of the HACCP plan, the

establishment shall conduct activities

designed to determine that the HACCP plan

is functioning as intended. During this

HACCP plan validation period, the

establishment shall repeatedly test the

adequacy of the CCPs, critical limits,

monitoring and record keeping procedures,

and corrective actions set forth in the HACCP

plan. Validation also encompasses reviews of

the records themselves, routinely generated

by the HACCP system, in the context of other

validation activities.

FSIS explains the derivation of the

proposed lethality performance

standards in the following section. A

technical paper (Ref. 3, available for

viewing by the public in the FSIS

Docket Room and on the Internet.1)

explaining the derivation of the lethality

performance standards also is available.

Establishments are encouraged to use

this paper when developing alternative

lethalities. In the paper, FSIS explains

the methodology used to calculate the

probability of remaining Salmonella

organisms in treated product.

Notably, with any final action, FSIS

will provide compliance guides that

give explicit processing instructions and

time/temperature combinations proven

to achieve the proposed decimal

reductions of pathogens. Small and

other establishments that do not have

the technical resources to demonstrate

that they are meeting the proposed

Federal Register / Vol. 66, No. 39 / Tuesday, February 27, 2001 / Proposed Rules 12595

performance standards may use these

compliance guides to develop their

HACCP systems. FSIS has published

compliance guides for meeting the

lethality and stabilization performance

standards already set forth in its January

6, 1999, final rule, has posted these

documents to the FSIS web page (http:/

/www.fsis.usda.gov), and has made the

documents available free of charge via

the Constituent Update (see section XIV

Additional Public Notification) and the

FSIS docket room. FSIS expects to make

additional draft guidance documents

available after publication of this

proposed rule and as information

becomes available in order to provide

establishments with guidance for safely

manufacturing RTE meat and poultry

products. These draft guidance

materials will be clearly identified as

guidance materials and not as regulatory

requirements. These guides would be

applicable to the processing of many of

the RTE meat and poultry products

governed by these proposed regulations.

FSIS plans to update these guides soon

in accordance with ongoing Agricultural

Research Service studies. Where

possible, FSIS will base its compliance

guides on existing industry practices

and requests comment and information

regarding processing that has been

shown to meet the proposed

performance standards.

Derivation of the Proposed Lethality

Performance Standards

Salmonella

To derive the proposed lethality

performance standards for Salmonella,

FSIS first determined the levels of

Salmonella in a hypothetical worst case

raw product of a fixed weight. The

hypothetical ‘‘worst cases’’ for

Salmonella and E. coli O157:H7 were

derived using data from FSIS’s

Nationwide Microbiological Baseline

Data Collection Program surveys (Ref. 4,

available for viewing by the public in

the FSIS Docket Room). The baseline

surveys conducted by FSIS were

designed to provide estimates of the

national prevalence and levels of

selected bacteria of public health

concern. Salmonella was one of the

pathogens specifically addressed in all

of the baseline surveys for the various

classes of products. The baseline

surveys were conducted over a specified

period of time ranging from a half year

to a full year. The baseline surveys were

used to establish the pathogen reduction

performance standards for Salmonella

that were included as a component of

the Pathogen Reduction-HACCP final

rule of July 25, 1996 (61 FR 38806). The

performance standards for Salmonella

that were established as part of the

Pathogen Reduction-HACCP final rule

differ from the proposed lethality

performance standards for Salmonella

included as part of this proposed

rulemaking.

The Salmonella performance

standards for the Pathogen ReductionHACCP final rule are designed as

follows: they are applicable to

establishments that produce raw

products; FSIS collects and tests

samples from raw product; the results of

the raw product samples are reported to

the establishment by FSIS after a

specified number of samples are

collected over time; and a positive result

for Salmonella in raw product generally

does not result in an adulteration

determination. In contrast to this design,

the Salmonella lethality performance

standards of this proposed rule are

designed as follows: they are applicable

to establishments that produce ready-toeat products (not raw product); the

establishment may sample and test

samples of RTE product as part of its

verification activity associated with the

production of RTE product and any

testing by FSIS is conducted as part of

the Agency’s verification activity; and a

positive result for Salmonella in RTE

product does result in an adulteration

determination. The premise and use of

the lethality performance standards for

Salmonella in this proposed rule are

unchanged from those previously

contained in the recent final rule for

RTE products (64 FR 732, January 6,

1999). Consequently, the baseline

surveys were used in the design of two

separate performance standards: one

performance standard identifies the

prevalence of Salmonella in raw

product over a specified period of time;

the other performance standard

(addressed as part of this proposed rule)

identifies the expected reduction in the

level of Salmonella in RTE product in

a specified lot of product. Since these

two performance standards apply to

different types of establishments (i.e.,

the former applies to establishments

producing raw product; the latter

applies to establishments producing

RTE product), they are not duplicative

standards nor do they directly relate to

each other. The only commonality

between these two performance

standards for Salmonella is that they are

both derived from the same baseline

surveys. The level of E. coli O157:H7 in

raw products also was assessed in the

same baseline studies as were used to

determine the level of Salmonella in

raw products.

Using the national baseline survey

information to establish the levels of

selected bacteria of public health

concern (e.g., Salmonella), the Agency

then determined levels of lethality that

would limit the probability of any

remaining Salmonella or E. coli

O157:H7 in finished product produced

from worst case raw product. FSIS made

conservative but reasonable

assumptions concerning measurement

error and distributions of organisms

throughout the product. These

assumptions are fully discussed in the

technical paper (Ref. 3, available in the

FSIS Docket Room and at the FSIS web

page http://www.fsis.usda.gov).

However, the assumptions are generally

based on the following which are

further discussed below: the number of

organisms recovered from frozen

samples; the sensitivity of the detection

methodology; the confidence level of

measurement variability; and the

serving size. Thus, worst case levels in

product are not expected to actually

occur, provided products are handled

appropriately before lethality

treatments. The derived worst case

levels are hypothetical constructs meant

to represent upper limits of possibilities

for raw product produced under

appropriate, normal manufacturing

conditions. These conditions include

maintaining the raw product at or below

temperatures known to prevent growth

of Salmonella and most other

pathogenic organisms (e.g., at or below

40 degrees Fahrenheit). In addition, they

include processing the raw product into

RTE product quickly before the raw

product’s surface temperature becomes

elevated for sufficient amounts of time

to allow Salmonella and most other

pathogenic organisms to multiple

exponentially. FSIS believes that under

these conditions, processes that satisfy

the performance standards established

as a result of this rulemaking will be

safe.

The Agency used the most probable

number (MPN) method for measuring

levels of Salmonella in the FSIS surveys

of meat and poultry products. The MPN

measurements were made on frozen

samples. The calculations used to

determine the number of organisms for

the worst case product take into account

non-recovery of organisms in frozen

samples.

For Salmonella, the Agency assumed

a 30 percent recovery of organisms from

frozen samples (Ref. 3, available for

viewing by the public in the FSIS

Docket Room). The expected recovery is

a function of how quick and long the

sample was frozen. Based on FSIS

experience with samples, the

approximate detection limit for recovery

of Salmonella is 0.5 cells per gram in

25-gram frozen samples. This means

that there is a high probability that a 25-

12596 Federal Register / Vol. 66, No. 39 / Tuesday, February 27, 2001 / Proposed Rules

2While the numbers of samples in the FSIS

national surveys are rather large, the largest MPN

value, as an estimate of large densities of

pathogenic organisms, from a statistical perspective,

may have substantial statistical variation. Thus, to

reduce differences in required lethality reductions

caused by statistical variation, data sets of different

species were combined if warranted by

consideration of the prevalences and possibly the

geometric means of the levels of the organisms for

these species. The high value of combined data sets

was used for determining the hypothetical worst

case for these species. The criteria used for

combining data sets of different species are easier

stated as the converse of criteria for when data sets

would not be combined and thus the lethality

requirements for these species would be different.

The criteria for determining when lethality

requirements for two species, A and B, are different

are: For a given type of product, the lethality

requirement for species A is larger than that of

species B if (1) the high MPN value for species A

is larger than that of species B, and (2) the

prevalence for species A is larger than that of

species B, or the prevalences are approximately

equal and the geometric mean for species A is larger

than that of species B. Otherwise, the lethality

requirements would be the same and the high value

of the combined data set would be used for both

species A and B. For the products and pathogen

considered in this proposed regulation, the criteria

for combining data depend upon the prevalences

and the high values.

gram sample with 13 organisms would

be found positive. For the purposes of

this regulation, the Agency assigned a

99% probability that a 25-gram sample

with 13 Salmonella cells would test

positive. Even if one organism were

recovered, the sample result would be

positive, so that the probability of a

positive sample result can be expressed

as 1τ13, where τ is the theoretical

probability of a single injured or

uninjured Salmonella organism not

being recovered. With this assumption,

for frozen samples, τ is approximately

70%, that is, there is a 70% probability

that a single organism would not be

recovered. Thus, there is a 30%

recovery of Salmonella cells.

To account for measurement

variability, the Agency calculated the

97.5 percent upper confidence limit

associated with the measured MPN

value (Ref. 3, available for viewing by

the public in the FSIS Docket Room).

FSIS did not use the average level of

Salmonella reported for the various

classes of product. Rather, in order to

determine the highest estimate for the

level of Salmonella in raw products,

FSIS took the raw data, not the

calculated average, and computed a

number at the 97.5 percent upper

confidence level. Using this upper limit,

the Agency then computed the upper

limit for 143 grams of raw product. The

Agency used 143 grams of raw product

as the basis for its calculations because

after cooking, assuming a 70 percent

yield, 143 grams would result in

approximately 100 grams (3.5 ounces) of

cooked product.

The Agency used the high MPN value

for ground chicken (the highest MPN

value measured for poultry products)

from the FSIS national baseline

surveys 2 to determine the proposed

lethality for Salmonella for all RTE

products containing poultry, other than

thermally processed, commercially

sterile products. For ground chicken,

the upper 97.5 percent confidence limit

for the highest measured MPN value of

2300 MPN per gram for Salmonella,

assuming a 30 percent recovery, is

approximately 37,500 cells/gram,

which, when multiplied by 143 grams

totals approximately 6.7-log10 cells.

Therefore, the level of Salmonella

organisms in a hypothetical worst case

raw product would be greater than 6.5-

log10 but just less than 7.0-log10.

Consequently, to provide a margin of

safety and to use either a whole or half

integer lethality, FSIS is proposing to

require a reduction in viable Salmonella

of 7.0-log10, which is 0.3-log10 above the

worst case level, throughout RTE

products that contain poultry, other

than thermally processed, commercially

sterile products. The consequence of

this choice is that, for a hypothetical

‘‘worst case’’ product, the probability of

surviving Salmonella organisms is

39.4%, assuming that the distribution of

the number of survivors is binomial

with number parameter equal to the

number of organisms in the worst case

and the probability parameter equal to

1/10x where x is the required decrease

in viability.

Alternatively, an establishment may

use a processing procedure validated to

achieve the probabilities in Table 1

above that no more than specific

amounts of Salmonella would remain in

any 100 gram sample of a finished,

hypothetical worst case product. As

stated above, these probabilities would

result in hypothetical worst case poultry

products that had been successfully

processed to achieve a 7-log10 reduction

in Salmonella.

To determine the proposed lethality

for RTE meat products that do not

contain poultry, other than thermally

processed, commercially sterile

products, the Agency used the high

MPN value for whole beef (the highest

MPN value measured for all meat

products): 240 MPN/cm2. To translate

this value to a level per gram, FSIS

assumed that, for a worst case level, a

cut of meat is 0.8 cm and that the

specific density of beef is approximately

1.1 grams/cm3 (slightly lower than

average) (Ref. 3, available for viewing by

the public in the FSIS Docket Room).

These factors are for practical purposes

equal to 1, so that the MPN/cm2 values

are assumed to estimate the level per

gram of product. Thus, for the worst

case derivation, the starting value is 240

MPN/g.

The 97.5 percent upper confidence

limit, assuming a 30 percent recovery, is

4100 cells/g. Because samples for the

whole product surveys consisted of

pooled tissue from 3 different carcass

sections, and the prevalence was low

(less than 3 percent), the Agency

assumed that the high value used for

determining the worst case product is 3

times that of the measured MPN value.

Thus, the 97.5 percent upper confidence

limit is multiplied by 3 and then

multiplied by 143 grams. The resulting

number of organisms for the worst case

product is approximately 6.2-log10.

Therefore, to provide the same margin

of safety as provided for with poultry

products, the proposed required

lethality is obtained by adding 0.3 log10

to the worst case level of 6.2 log10. Thus,

FSIS is proposing to require either a

relative reduction in viable Salmonella

of 6.5-log10 throughout finished, RTE

meat products, or alternatively, one of

the probabilities listed above in Table 1.

FSIS has not specified the probability of

worst case product actually occurring

since the worst case was a hypothetical

construct based, in part, on a high

confidence level of the maximum

observed level of microorganisms in a

statistically designed national baseline.

In addition, FSIS made additional

assumptions that FSIS believes to be

conservative. All the assumptions

regarding the derivation of the worst

case are contained in the technical

paper (Ref. 3, available in the FSIS

Docket Room and at the FSIS web page,

http://www.fsis.usda.gov). FSIS requests

comments regarding these assumptions.

E. coli O157:H7

After a 1994 outbreak of illnesses

caused by E. coli O157:H7, FSIS

recommended that producers of

fermented RTE products that contain

any amount of beef validate their

processes to achieve a 5.0 log10 lethality

of E. coli O157:H7 (see additional

discussion under Fermented Products).

This recommended lethality was based

on a report submitted to FSIS (The Task

Force on Technical Issues Arising from

the National Advisory Committee for

Microbiological Criteria for Foods

(NACMCF)). The 5-log10 relative

reduction was derived by adding 1 log10

as a safety margin to an assumed worst

case of 4.0 log10 that was recommended

by the NACMCF. If this lethality were

applied in a product containing 104

cells per gram, then it would be

expected that a single cell would

remain. However, the conclusion that a

Federal Register / Vol. 66, No. 39 / Tuesday, February 27, 2001 / Proposed Rules 12597

single E. coli O157:H7 cell per 10 grams

(or a possible 10 cells per 100 grams)

remaining in the product adequately

prevents foodborne disease is in

question. Some researchers now believe

that low numbers of E. coli O157:H7

cells ingested are sufficient to cause

foodborne disease (Ref. 5, available for

viewing by the public in the FSIS

Docket Room).

Presented in chapter 5 of the OPHS

risk assessment are results of a

derivation of the possible number of E.

coli O157:H7 cells in combo bins of

2000 pounds or approximately 105.96

grams (Ref. 1, available for viewing by

the public in the FSIS Docket Room).

The highest number associated with a

non-zero probability is 107 cells for

which an upper bound probability of

occurrence is 0.002% (1/50,000). As

discussed above in the derivation of the

proposed lethality requirements, the

Agency considers the number of cells in

143 grams of raw product, accounting

for a possible 70% yield when the

product is processed. A bin with 107

cells implies that the expected number

of cells in 143 grams of raw product

would be about 3.2 log10 cells per 100

grams. The assumptions used in

deriving this number assume that the E.

coli O157:H7 cells present are uniformly

distributed throughout the bin, so that

the 3.2 log10 represent an average or

expected number of cells per 143 grams

of product. It is clearly possible that

there would be in some 143-gram

portion more than 3.2 log10 E. coli

O157:H7 cells. Thus, a worst case level

should be larger than 3.2 log10 E. coli

O157:H7 cells.

To derive worst case levels for E. coli

O157:H7 for the purpose of determining

a performance standard, the Agency

applied the algorithm, described above

for Salmonella, using information

presented in OPHS risk assessment.

This risk assessment presented results

of MPN analyses from the Agency’s

microbiological baseline surveys of

bovine carcasses (Ref. 1, available for

viewing by the public in the FSIS

Docket Room). In total, out of about

4,000 samples, 4 samples were found

positive. For each positive a matching

sample was analyzed using the MPN

procedure. Of the 4 analyzes, 2 were

found positive. The highest reported

MPN value was 0.93 cells/cm2, which,

as described above, is assumed to

represent level per gram value, or 0.93

MPN/gram. A 97.5 percent upper

confidence limit for this value is 3.7

cells/cm2. FSIS did not use the average

level of E. coli O157:H7 reported for the

various classes of product. Rather, in

order to determine the highest estimate

for the level of E. coli O157:H7 in raw

products, FSIS took the raw data, not

the calculated average, and computed a

number at the 97.5 percent upper

confidence level.

The samples used for determining E.

coli O157:H7 levels in the FSIS surveys

were frozen. In the OPHS risk

assessment, information concerning the

recovery rate is given. It is stated in the

report that nine 25-gram samples of

ground beef were inoculated with 0.7 E.

coli O157:H7 organisms per gram, and

that eight of these samples subsequently

were detected as positive. In

determining the possible recovery for E.

coli O157:H7 cells in a sample that is

subsequently frozen, FSIS assumes that

the actual number of cells in a specified

25-gram sample is a random variable, n,

following a Poisson distribution, f(n, λ)

= e ¥λλ/n!, with expected value λ =

17.5. If τ is the probability of not

recovering a given single cell, then the

probability of detecting the presence of

E. coli O157:H7 in a 25 gram sample, is,

π = Σ (1¥τn)f(n, λ) = 1¥e ¥λ(1¥τ). Thus,

the probability of recovering a given cell

is 1¥τ = ¥ln(1¥π)/λ. From nine

samples, eight were detected positive,

so that a 97.5% lower confidence bound

for π is 0.6635. Using this value for π,

the derived value for 1¥τ is 0.062,

representing the recovery. For the worst

case level, the 97.5 percent upper

bound, 3.7 cells/cm2, is divided by

0.062 to derive 59.45 cells/cm2.

As described above for deriving the

worst case levels for Salmonella in beef,

the measured levels are multiplied by 3,

to account for the fact that samples from

the bovine FSIS baseline surveys

consisted of a composite from 3 sections

of the carcass, and for a worst case

derivation, FSIS assumes that all the

cells existed in one of the three sections.

Thus, for the worst case level, the 59.45

cells/cm2 is multiplied by 3, and then

multiplied by 143 grams to derive an

approximate 4.4 log10 cells for the worst

case level.

The above derivation indicates that

the ‘‘worst case’’ level of 4.4 log10 cells

per 143 grams is greater than the highest

expected level of 3.2 log10 cells per 143

grams derived in the OPHS risk

assessment. Consequently FSIS will use

the 4.4 log10 as the ‘‘worst case’’ level.

To provide the same margin of safety

as provided for with Salmonella in

poultry and red meat products, the

lethality is obtained by adding 0.3 log10

to the worst case level of 4.4 log10.

However, foodborne illness associated

with E. coli O157:H7 might be more

severe than that associated with

Salmonella, as testified to by the

severity of many reported cases in

children and senior citizens. Also, as

stated above, some researchers believe

that low numbers of ingested E. coli

O157:H7 cells are sufficient to cause

foodborne illness. Furthermore, there is

only a small amount of data from the

Agency’s microbiological baseline

survey: four samples, of which only two

were positive. This number of samples

does not provide a high degree of

confidence in the magnitude of the

higher levels that might exist.

Consequently, FSIS is requiring that

processors of fermented products

containing beef achieve a higher

probability of no surviving cells of E.

coli O157:H7 in treated worst case

products than that required for

Salmonella. Specifically, FSIS is

proposing a 5-log10 lethality, which can

be obtained by adding 0.6 log10 to the

‘‘worst case’’ level (instead of 0.3 log10

added for Salmonella). The probability

of no surviving E. coli O157:H7 cells

given a ‘‘worst case’’ level of cells is

about 78% (instead of 61% for

Salmonella).

FSIS also examined measured levels

of E. coli O157:H7 found in suspect lots

of hamburger identified in foodborne

disease outbreaks (Refs. 6 and 7,

available for viewing by the public in

the FSIS Docket Room). Direct count

determinations were as follows: 50, 100,

5100, and 6200 colony forming units

(CFU) per gram. Because of the

possibility that the high E. coli O157:H7

levels represent product that has been

abused and thus are not representative

of product produced in an

establishment and used in RTE product,

FSIS could not, with complete

justification, use these values for

determining a required lethality.

However, these results do suggest that a

lethality of at least 5-log10 is needed to

help ensure an E. coli O157:H7 free RTE

product.

The derivation for the proposed

lethality of E. coli O157:H7, in using

only a slightly higher probability of no

surviving cells compared to that used

for deriving the proposed lethalities for

Salmonella, assumes only a slightly

greater public health concern for E. coli

O157:H7. However, foodborne illness

associated with E. coli O157:H7 might

be significantly more likely than that

associated with Salmonella. As

mentioned above, some researchers now

believe that low numbers of E. coli

O157:H7 cells ingested are sufficient to

cause foodborne disease. This belief also

is reflected in the recent OPHS draft risk

assessment regarding E. coli O157:H7 in

ground beef (Ref. 1, available for

viewing by the public in the FSIS

Docket Room). The dose response model

used in this report allows the possibility

of a 1% probability of illness when a

random selected consumer ingests a

12598 Federal Register / Vol. 66, No. 39 / Tuesday, February 27, 2001 / Proposed Rules

single cell; and when, ingesting 10 cells,

the probability of illness could be as

high as 10%.

Consequently, FSIS may need to

require that processors of fermented

products containing beef achieve a

higher probability of no surviving cells

of E. coli O157:H7 in treated worst case

products. For example, if the proposed

lethality were 5.5 log10, the probability

of no surviving E. coli O157:H7 cells in

the hypothetical worst case would be

92.4% instead of 77.8%; if the proposed

lethality were 6.0, then the probability

of no surviving E. coli O157:H7 cells

would be 97.5%.

Since the number of sample results

from which the worst case was derived

is small, there is not a high degree of

confidence in the magnitude of the

higher levels of E. coli O157:H7 that

might exist. Further information may

require FSIS to adjust the worst case

level and thus the required lethality,

accordingly. It is important to note,

however, that a fermentation process

offers an extra degree of safety

compared to a heat process, given the

same lethality. Unlike ordinary cooked

RTE products, the physio-chemical

environment within fermented products

is hostile to the survival of pathogens.

Thus, within an ordinary cooked RTE

product, sublethally injured bacteria

may be able to resuscitate and then

multiply when the temperature rises.

Within fermented sausages, most of

which are shelf-stable, resuscitation is

not possible. FSIS specifically requests

comment on the proposed performance

standard for the pathogen E. coli

O157:H7 in fermented products

containing beef.

FSIS has not specified the probability

of worst case product actually occurring

since the worst case was a hypothetical

construct based, in part, on a high

confidence level of the maximum

observed level of microorganisms in a

statistically designed national baseline.

In addition, FSIS made additional

assumptions that FSIS believes to be

conservative. All the assumptions

regarding the derivation of the worst

case are contained in the technical

paper (Ref. 3, available in the FSIS

Docket Room and at the FSIS web page,

http://www.fsis.usda.gov). FSIS requests

comments regarding these assumptions.

Selection of the Reference Organisms

An explanation of how the Agency

established the proposed reference

organisms for each category of RTE

product, other than thermally

processed, commercially sterile

products, follows.

Dried Products

The pathogens associated with dried

(but not fermented) RTE meat and

poultry products are Salmonella,

Listeria monocytogenes, Staphylococcus

aureus, E. coli O157:H7 and Trichinella

spiralis. T. spiralis is only associated

with pork and game products. There are

a limited number of studies on the

reduction of pathogens during the

processing of dried meat and poultry

products.

J. A. Harrison and M. A. Harrison

surface-inoculated one-third of a beef

jerky strip (15 × 1.5 × 1.5 cm.) with 0.1

ml of a 108 CFU/ml cell suspension each

of L. monocytogenes, Salmonella

typhimurium, and E. coli O157:H7 (Ref.

8, available for viewing by the public in

the FSIS Docket Room). Results show

that higher log reductions of the three

pathogens were obtained when beef

jerky was preheated to 160 °F and when

curing agents were added. In general, L.

monocytogenes was more resistant to

the treatments. However, after 10 hours

of drying at 140 °F, the populations

decreased to undetectable levels,

resulting in a 5.5 to 6.0 log reduction of

the three pathogens. After storage at 25

°C for 8 weeks, none of the pathogens

were detected. Subsequent challenge

studies on inoculated ground beef jerky,

with or without curing agents, heated or

unheated, showed that Salmonella spp.

was in general more resistant than L.

monocytogenes to the integrated

process. However, after 6 hours of

drying at 140 °F, L. monocytogenes and

Salmonella had about the same

population reduction in preheated

samples (Refs. 9 and 10, available for

viewing by the public in the FSIS

Docket Room).

These studies show that the time and

temperature of drying and other

variables, such as the use of beef strips

or formed ground beef jerky, the

addition of curing agents, and

preheating before drying, will affect the

reduction of pathogens. Lethality of

pathogens in dried products is achieved

by dehydration to a water activity (aw)

level that inhibits their growth.

Preheating or precooking and the

addition of curing agents facilitate and

add to the lethality factor.

In 1995, a salmonellosis outbreak was

associated with commercially produced

beef jerky linked to three Salmonella

serotypes (Ref. 11, available for viewing

by the public in the FSIS Docket Room).

The CDC Morbidity and Mortality

Weekly Report (MMWR) report stated

that the New Mexico Department of

Health investigated five outbreaks of

salmonellosis associated with locally

produced beef jerky from 1966 to 1988

and one outbreak of staphylococcal food

poisoning associated with beef jerky in

1982. Also according to the MMWR,

four other states reported foodborne

disease outbreaks associated with the

consumption of locally produced or

homemade jerky from beef, bear, or

cougar meat. The outbreaks were caused

by T. spiralis and by nitrite poisoning.

The MMWR set out the

recommendations of CDC for the

prevention of bacterial growth in jerky

production. CDC recommended rapid

drying at high temperatures (i.e., initial

drying temperature >155 °F (68.3 °C) for

4 hours, then >140 °F (60 °C) for an

additional 4 hours), and decreased

water activity (i.e., aw = 0.86).

E. coli O157:H7 was implicated in one

case in homemade venison jerky (Ref.

12, available for viewing by the public

in the FSIS Docket Room). L.

monocytogenes has not been reported to

be associated with any foodborne illness

attributable to the consumption of

commercial jerky products. So, based on

the epidemiological data and research

studies on jerky, it does not appear that

E. coli O157:H7 or Listeria represent

serious hazards in commercially

produced jerky. Consequently, FSIS

chose Salmonella as the proposed

reference organism for dried products.

If a process used to produce dried

products achieves the proposed

reduction in the number of Salmonella

organisms, the number of T. spiralis, E.

coli O157:H7, and S. aureus should also

be reduced to safe levels because these

organisms are generally less heat

resistant than Salmonella. L.

monocytogenes is a problem more often

because of inadequate sanitation than

inadequate processing. Under HACCP

and Sanitation SOP requirements,

establishments must ensure that their

processing controls hazards in addition

to Salmonella, such as L.

monocytogenes, if they are reasonably

likely to occur.

Salt-Cured Products

The microbiological stability (the

lethality during processing) of salt-cured

meats, such as salt-cured hams, is

dependent on their low water activity,

the presence of nitrite, and smoke

applied between the salting and drying

processes (Ref. 13, available for viewing

by the public in the FSIS Docket Room).

Lethality of pathogens in the salt-cured

products is attained by low temperature

salting and drying. Both of these

processes reduce the water activity to

levels that inhibit the growth of

pathogens. The addition of nitrates or

nitrites and smoke enhance the

inhibitive effect of the process.

Federal Register / Vol. 66, No. 39 / Tuesday, February 27, 2001 / Proposed Rules 12599

There were two salmonellosis

outbreaks linked to salt-cured hams:

Serrano variety cured ham in Spain and

prosciutto ham in Italy (Refs. 14 and 15,

available for viewing by the public in

the FSIS Docket Room). Low levels of

salt and relatively high water levels in

some parts of the Serrano variety cured

ham were judged to be the most

probable cause of Salmonella growth

and consequent illness. Aside from

Salmonella, other pathogens of concern

in salt-cured products are S. aureus, L.

monocytogenes, and T. spiralis. The

Agency is proposing to select

Salmonella as the reference organism

because outbreaks in salt-cured

products have been associated with

Salmonella. As with dried products, if

the process used to produce salt-cured

products achieves the proposed

6.5¥log10 or 7.0-log10 reduction in

Salmonella organisms, the number of

these other pathogens should also be

reduced to safe levels. In addition,

establishments would have to ensure

that processing also controls hazards

other than Salmonella, including other

pathogens, that are reasonably likely to

occur.

Fermented Products

In late 1994, 23 cases of illness caused

by the pathogen E. coli O157:H7 were

reported in Washington State and

northern California (Ref. 16, available

for viewing by the public in the FSIS

Docket Room). Epidemiological

investigations by State and local health

agencies associated the outbreak with

the consumption of dry cured salami

products. In October 1995, the

Pennsylvania State Department of

Health linked 26 cases of salmonellosis

to the consumption of contaminated

Lebanon bologna (Ref. 17, available for

viewing by the public in the FSIS

Docket Room).

After the 1994 outbreak of illnesses

caused by E. coli O157:H7, FSIS met

regularly with scientists from the

Agricultural Research Service,

representatives of the meat and poultry

industry and members of the NACMCF

to develop a policy for ensuring the

safety of shelf-stable, RTE fermented

sausages. This group developed several

processing options that would ensure a

5-log10 relative reduction of E. coli

O157:H7 in fermented sausages. In

addition, FSIS approved a processing

option developed by the Blue Ribbon

Task Force on E. coli O157:H7 of the

National Cattleman’s Beef Association.

As explained previously, the 5-log10

reduction of E. coli O157:H7 in dry and

semidry fermented sausages was

originally based on the notion of adding

a 1-log10 safety margin over an assumed

worst case of 104 CFU/gram in raw

product. FSIS offered 4 options to either

achieve the recommended 5-log10

relative reduction of E. coli O157:H7 or

control for its presence in finished

product: (1) Apply the cooking

treatment in either 9 CFR 318.17 or

318.23, (2) apply a validated integrated

heat treatment of equal lethality, (3) test

product using ICMSF lot acceptance

criteria, or (4) apply a validated 5-log10

relative reduction or process that results

in less than 1 E. coli O157:H7 per 100

gram of finished product. The Blue

Ribbon Task Force of the National

Cattlemen’s Beef Association

specifically addressed Option 2—a

validated 5-log10 inactivation treatment.

The Task Force focused on the

processing parameters of heat and acid

sensitivity of the organism. The

processes and the resultant level of

reduction of E. coli O157:H7 were

summarized in a table and flow chart.

In addition, the report recommended a

fifth option, combination of sampling of

raw ingredients and a 2-log10 lethality

treatment, and described the remaining

3 options.

On August 21, 1995, FSIS wrote to

establishments producing fermented

sausages and strongly encouraged that

they implement one of the validated

processing options contained in the

document to ensure the processing used

achieves at least a 5-log10 relative

reduction of E. coli O157:H7. While

most establishments have implemented

one of the processing options, not all

have.

As discussed previously, in support of

rulemaking, OPHS has sponsored a risk

assessment of E. coli O157:H7 in ground

beef (Ref. 1, available for viewing by the

public in the FSIS Docket Room). The

draft risk assessment presents data on

the prevalence of E. coli O157:H7 among

breeding herds and feedlots of cattle,

and E. coli O157:H7 levels on carcass

samples. This information shows that

levels of E. coli O157:H7 in cattle

represents a risk to consumers of ground

beef, and that, unless there is a

significant intervention on the farm or

during processing, the risk is likely to

remain.

In addition, because of the incidence

of foodborne illness linked to E. coli

O157:H7 in fermented sausages and

because these products ordinarily are

not fully cooked before being fermented

(which creates a situation that may

allow the survival of E. coli O157:H7),

the Agency is proposing to include E.

coli O157:H7, in addition to Salmonella,

as a reference organism for fermented

RTE meat and poultry products that

contain beef.

Under this proposal, processing of

fermented products that contain beef

would be required to meet lethality

performance standards for both

Salmonella in § 430.2(a) and for E. coli

O157:H7 in § 430.2(b). As discussed

under the ‘‘Lethality’’ heading above, for

fermented RTE meat and poultry

products that contain beef, the Agency

is proposing that processing achieve

either specific probabilities of remaining

organisms in 100 grams of finished

product, or a 5.0-log10 relative reduction

of E. coli O157:H7 throughout the

product, which would achieve those

probabilities in a hypothetical, worst

case raw product. FSIS is not proposing

this performance standard for fermented

meat and poultry products that do not

contain beef.

The Agency tests fermented sausage

products for Salmonella, L.

monocytogenes , E. coli O157:H7, and

staphylococcal enterotoxin. Isolation or

detection of any of these pathogens and

enterotoxin results in product recall and

destruction of product. With the

exception of L. monocytogenes, these

pathogens and staphylococcal

enterotoxin have been linked to

foodborne illness associated with

fermented sausage products. With

regard to S. aureus, the production of a

heat stable enterotoxin (staphylococcal

enterotoxin) after it has achieved a

density of at least 105 CFU/g rather than

the bacterium itself is responsible for

foodborne illness. Growth of S. aureus

is inhibited by the competitive growth

of lactic acid bacteria, such as

lactobacilli and pediococci, which are

often used in fermented sausage

products (Refs. 18 and 19, available for

viewing by the public in the FSIS

Docket Room).

A suboptimally active fermentation

culture or an initial large number of S.

aureus, as has occurred when

contaminated starter culture is used,

may result in the growth of S. aureus

and the production of enterotoxin.

However, since 1980, the industry has

implemented fermentation controls, and

no repeat of the previous type outbreaks

has occurred. Therefore, FSIS is not

proposing S. aureus as a reference

organism for these products.

L. monocytogenes is the most

frequently isolated pathogen of those

included in the FSIS monitoring

program for fermented sausages. Despite

its prevalence in fermented sausage

products, no foodborne illnesses have

been linked to L. monocytogenes in

fermented sausages. Thus, the Agency is

not proposing that L. monocytogenes be

a reference organism for fermented

sausages; however, if the Agency were

to find L. monocytogenes in the finished

12600 Federal Register / Vol. 66, No. 39 / Tuesday, February 27, 2001 / Proposed Rules

product, the product would be

adulterated and subject to recall.

In a Lebanon bologna process, a 3- to

4-log10 reduction of Salmonella dublin

and a reduction of Salmonella

typhimurium to undetectable levels was

observed by the end of fermentation if

starter culture was used (Ref. 20,

available for viewing by the public in

the FSIS Docket Room). Similarly,

Bacus noted that contamination of

fermented meat products with

Salmonella most likely results from an

inadequate lactic acid production or a

highly contaminated raw product (Ref.

21, available for viewing by the public

in the FSIS Docket Room).

Various studies have shown that

fermentation and drying resulted in

about a 2-log10 reduction of E. coli

O157:H7 (Refs. 22 through 24, available

for viewing by the public in the FSIS

Docket Room). In one study, Glass, et

al., reported that E. coli O157:H7

decreased by about 2-log10 CFU/g after

fermentation, drying, and storage at 4 °C

for 6 weeks following the end of an 18–

21 day drying cycle for a fermented

sausage formulation. In another,

however, Faith et al., observed a 5- to

6-log10 reduction of E. coli O157:H7 in

pepperoni sticks following

fermentation, drying, and 2 weeks of

storage at an ambient (unrefrigerated)

temperature of 21 °C.

In one of the few studies that

compared the combined effect of

fermentation and drying on both

Salmonella and E. coli O157:H7,

Ellajosyula, et al., observed that the

reduction of Salmonella and E. coli

O157:H7 in Lebanon bologna was less

than 2- log10 after fermentation to pH 4.7

(Ref. 22, available for viewing by the

public in the FSIS Docket Room). In this

study, Salmonella was equally or

significantly (P<0.01) less resistant than

E. coli O157:H7 to various combinations

of pH levels achieved after fermentation

and subsequent heating at 110 °F to 120

°F. Fermentation to pH 5.2 or 4.7

followed by heating at 110 °F to 120 °F

for specified times (e.g., 110 °F for 20

hours or 120 °F for 3 hours) resulted in

a greater than 7- log10 reduction of both

Salmonella and E. coli O157:H7. This

study shows that a final heating step

may be necessary to achieve the

proposed reduction of both Salmonella

and E. coli O157:H7 in fermented

sausage products.

Salmonella and E. coli O157:H7 have

been the cause of foodborne illnesses

linked to fermented sausage products.

Although, as noted above, Salmonella

may be less resistant than E. coli

O157:H7 to the processes for the

different fermented meat products, it

has not been demonstrated that

processes resulting in a 5.0-log10

reduction of E. coli O157:H7 will result

in a 6.5- log10 or 7.0- log10 reduction of

Salmonella in meat and poultry

products, respectively. Conversely,

processes resulting in a 6.5- or 7.0- log10

reduction of Salmonella have not been

shown to produce a 5.0-log10 reduction

of E. coli O157:H7. Therefore, a process

for fermented RTE products that contain

beef must be validated for both

pathogens.

Cooked and Otherwise Processed Whole

or Comminuted Meat Products

As stated above, FSIS already has

made final lethality performance

standards for certain RTE meat

products, including RTE cooked beef,

corned beef, and roast beef. In this

document, FSIS is proposing to extend

these performance standards to all other

cooked and otherwise processed (e.g.,

cured) meat products. Under this

proposal, establishments would be

required to employ processing validated

to achieve specific probabilities (Table

1) that only small numbers of

Salmonella organisms could remain in

finished cooked or otherwise processed,

whole and comminuted, RTE meat

products. Alternatively, an

establishment could use a process

validated to achieve a 6.5-log10

reduction of Salmonella throughout a

finished RTE meat product.

As with cooked beef, corned beef, and

roast beef, the primary pathogenic

microorganism of concern in these other

RTE meat products has been

Salmonella. FSIS tentatively finds that

the destruction of Salmonella in these

products will result in the destruction of

most other pathogens. FSIS is not

proposing to require that any particular

means be used to meet the lethality

standard. Cooking, for example, would

not need to be the sole means by which

lethality would be achieved. Other

applicable treatments, such as curing or

other controls, could be used in

combination with cooking to achieve

the required lethality.

Meat Patties

In the proposal preceding the January

1999 final rule that established

performance standards for certain RTE

meat and poultry products, FSIS

identified Salmonella as the target

pathogenic microorganism in fullycooked, uncured meat patties and

proposed a 5-log10 reduction in

Salmonella as the lethality performance

standard. FSIS made a tentative finding

that a 5-log10 reduction in Salmonella in

cooked, uncured meat patties would

effectively eliminate most other

bacterial pathogens of concern. Notably,

compliance with the time/temperature

requirements already contained in the

regulations effectively achieved a 5-log10

reduction in Salmonella.

However, FSIS did not make final the

lethality performance standards

proposed for RTE comminuted meat

patty products. In the course of

developing the final regulation, FSIS

determined that a higher lethality was

likely necessary to produce RTE,

uncured meat patties that would pose

no health risk to consumers. The

Agency could find no conclusive

information demonstrating that the

distributions of bacteria on ground and

whole product produced under normal

manufacturing conditions would

present comparatively higher or lower

risks to consumers. Furthermore, most,

if not all, RTE meat and poultry

products will be manufactured from the

same supply of raw product examined

in the FSIS national baseline surveys.

So, using performance standards that

would render any hypothetical, worst

case raw product safe should be

applicable to all categories of RTE meat

and poultry products.

Consequently, FSIS is proposing to

require that establishments achieve a

6.5-log10 reduction of Salmonella in all

RTE meat products, including RTE meat

patties. FSIS believes that many

establishments are achieving this higher

lethality already, either through a

cooking step or a combination of

treatments. Furthermore, new and

innovative processing technologies,

including irradiation of raw product,

should allow establishments to achieve

this lethality without significantly

altering the quality of their products

through overcooking.

Cooked and Otherwise Processed Whole

or Comminuted Poultry Products

Again, FSIS recently made final

lethality performance standards for all

fully cooked, RTE poultry products,

such as poultry rolls. In this document,

FSIS is proposing to extend these

performance standards to all other

cooked and otherwise processed (e.g.,

cured) RTE poultry products. Under this

proposal, establishments would be

required to employ processing validated

to achieve specific probabilities that

only small numbers of Salmonella

organisms could remain in finished

cooked or otherwise processed, whole

and comminuted, RTE products that

contain any amount of poultry.

Alternatively, an establishment could

use a process validated to achieve a 7-

log10 reduction of Salmonella

throughout a finished product.

The primary pathogenic

microorganism of concern in these other

Federal Register / Vol. 66, No. 39 / Tuesday, February 27, 2001 / Proposed Rules 12601

RTE poultry products has been

Salmonella. FSIS tentatively finds that

the destruction of Salmonella in these

products will result in the destruction of

most other pathogens. For example,

Campylobacter jejuni was not selected

as a reference organism in RTE poultry

product, even though it is present at

high levels in poultry, because it is

generally recognized as being very

sensitive to heat. As with the analogous

meat products, FSIS is not proposing to

require that any particular means be

used to meet the lethality standard. For

example, various treatments, such as

curing or other controls, can be used in

combination with cooking to achieve

the required lethality.

B. Stabilization

In addition to lethality standards,

FSIS is proposing that processing used

to produce all RTE products, other than

thermally processed, commercially

sterile products, and processing used to

produce partially heat-treated products,

meet stabilization performance

standards. The proposed stabilization

standards require that establishments

control their production processes to

prevent the multiplication of sporeforming microorganisms. Stabilization is

typically achieved through cooling a

product after cooking. Specifically, the

Agency is proposing to require that

establishments producing these

products ensure that there is no

multiplication of toxigenic

microorganisms, such as Clostridium

botulinum, that potentially would create

harmful toxins in the product, and that

there is no more than a 1-log10

multiplication of Clostridium

perfringens within the product.

FSIS is proposing this performance

standard because the means applied to

products to bring about the lethality of

certain microorganisms in RTE

products, particularly heat treatment,

can create a model environment for the

multiplication of spore-forming bacteria.

The processing for many RTE products

includes a heat treatment. Spores of C.

botulinum, C. perfringens, and other

spore-forming bacteria can survive

cooking and, in fact, can thrive in the

warm product following cooking after

competitive microorganisms, such as

Salmonella or lactic acid bacteria, have

been eliminated. Anaerobic, nonrefrigerated conditions also facilitate

multiplication and growth of these

organisms.

Similarly, during processing,

partially-heat treated meat and poultry

products are partially cooked and then

cooled, which creates a model

environment for the growth of C.

perfringens, C. botulinum, and other

spore-forming, toxigenic bacteria.

Cooking by the consumer, retailer, or

other end-user may not eliminate these

bacteria or the toxins that they create in

these products. Therefore, it is

important that bacterial growth be

controlled in these products to the

extent possible before they reach the

end consumer.

The stabilization performance

standards are identical to the standards

made final in the January 1999

performance standard rulemaking, cited

above, for RTE products and partiallycooked poultry and meat patties. The

purpose for imposing the no (zero)

multiplication of C. botulinum standard

was to ensure that harmful toxins would

not be created in the product during

cooling. Toxins are created only when

there is multiplication of C. botulinum,

or other spore-forming, toxigenic

bacteria. When spores germinate and

reach the outgrowth stage, even slight

temperature abuse to the product can

result in cell multiplication and, if there

are sufficient numbers of cells,

subsequent toxin formation. Thus,

logically, ensuring no growth of these

bacteria would provide the greatest

amount of safety. Microscopic

examination of cells can be used to

determine whether cells have

germinated and reached outgrowth

stage.

The Agency requests comments on

whether the C. botulinum standard

should be no (zero) multiplication as

proposed. The Agency also requests any

data to support a tolerance in place of

the proposed C. botulinum standard.

The primary purpose for the zero

growth standard is to ensure that

harmful toxins will not be created in

cooked product during cooling. If there

were cell multiplication during cooling

and sufficient numbers of cells, there

could be subsequent toxin formation.

Thus, ensuring no growth C. botulinum

provides for the safety of the product

with the greatest amount of confidence.

It is possible that there can be a small

amount of C. botulinum growth within

the time of a 1-log10 relative growth of

C. perfringens. If the relative growth of

C. botulinum were greater than zero, but

less than some small amount, the

affected product could possibly be

considered safe for consumption,

provided it is also assumed that the

initial levels of C. botulinum were not

high. This assumption would be a

reasonable one, since generally the

levels of C. botulinum in raw meat are

low. However, in this situation, the

consequence of the low-level C.

botulinum assumption being incorrect

and of the possible toxin production

would be severe.

It is possible that compliance with the

proposed zero growth standard for C.

botulinum could impose a significant

burden on industry. Because there may

be growth of C. botulinum during a 1-

log10 relative growth of C. perfringens,

compliance with the proposed zero

growth standard for C. botulinum could

effectively require establishments to

meet a more restrictive standard than

that for C. perfringens. Further,

demonstrating ‘‘no multiplication’’ by

experiments (microscopic examination

of cells to determine whether cells have

germinated and reached outgrowth

stage) could be expensive. Also, to the

Agency’s knowledge, there are not

extensive data on which to build

mathematical models for predicting the

time before cell germination or

outgrowth and using data from growth

curves to develop predictive models for

cell population growth is not propitious

for demonstrating no multiplication.

Usually with predictive growth models,

it is very difficult or impossible to show

a no occurrence event (zero-growth)

with high probability. Consequently,

FSIS requests comment on this issue,

and data to support a possible relative

growth tolerance in place of the zero

growth proposed C. botulinum standard.

The proposed stabilization

performance standard provides that any

more than 1-log10 multiplication of C.

perfringens will adulterate the product

for the following reasons: Viable counts

of 105 or greater of C. perfringens/gram

in finished product have been listed by

the CDC as one criteria for incriminating

C. perfringens as the causative agent of

foodborne illness (Ref. 25, available for

viewing by the public in the FSIS

Docket Room), although foods

responsible for C. perfringens outbreaks

usually contain at least 106 vegetative C.

perfringens cells per gram (Refs. 26 and

27, available for viewing by the public

in the FSIS Docket Room). In the FSIS

microbiological product surveys, some

samples were found to contain more

than 104, but less than 105, C.

perfringens/gram. It is a conservative

assumption with respect to public

health that the great majority of C.

perfringens in the raw product are

spores. Heating activates the spores that,

during the cooling, become vegetative

cells that can multiply to hazardous

levels. Given that there can be more

than 104 C. perfringens (spores) per

gram on raw product, it is possible that

there could be as many as 104 vegetative

C. perfringens/gram of these surviving,

after cooking, in the product. Therefore,

the Agency, using the aforementioned

CDC criteria as an upper limit that

should not be exceeded, has tentatively

12602 Federal Register / Vol. 66, No. 39 / Tuesday, February 27, 2001 / Proposed Rules

determined that a limit of no more than

1 log10 growth of C. perfringens is

appropriate to ensure that there would

be no more than 105 C. perfringens per

gram on the finished product after

cooling.

An academic researcher recently

suggested to the Agency that the

stabilization performance standard for

C. perfringens should apply only to the

surface of intact, whole muscle, RTE

products. This researcher stated that

there is no data indicating that the

interior of whole muscle products

would ever contain C. perfringens. FSIS

requests comment on this issue, as well

as any relevant research data.

V. Listeria monocytogenes

L. monocytogenes grows at low

oxygen conditions and refrigeration

temperatures, and survives for long

periods of time in the environment, on

foods, in processing plants, and in

household refrigerators. Although

frequently present in raw foods of both

plant and animal origin, it also can be

present in cooked foods due to postprocessing contamination. Consumption

of food contaminated with L.

monocytogenes can cause listeriosis, an

uncommon but potentially fatal disease

in newborns, the elderly, and persons

with weakened immune systems, such

as those with chronic disease, HIV

infection, or persons taking

chemotherapy for cancer. Listeriosis

also is a major concern in pregnant

women. Even though symptoms may be

relatively mild in the mother, the illness

can be transmitted to the fetus, causing

serious illness or fetal death.

Each year, according to the FDA–FSIS

draft risk assessment on L.

monocytogenes (Ref. 28, available for

viewing by the public in the FSIS

Docket Room), the bacteria cause an

estimated 2,493 cases of listeriosis. Of

these, 2,298 persons are hospitalized

and 499 persons die. The case-fatality

rate is high across the whole

population—20 deaths per 100 cases of

illness. Epidemiologic surveillance data

indicates that the case-fatality rate

varies by age, with a higher case-fatality

rate among newborns (<1 year) and the

elderly (>60 years). For a full discussion

on case-fatality rate, refer to the

‘‘Baseline Number of Listeriosis Cases

and Deaths and the Potential Benefits

from the Proposed Rule’’ section in

Appendix 1.

Since 1987, FSIS has conducted a

microbiological testing program in

which the Agency randomly samples,

in-plant, RTE meat and poultry products

produced in federally inspected

establishments for L. monocytogenes,

including cooked and fermented

sausages, cooked corned beef, sliced

ham and luncheon meats, beef jerky,

cooked uncured poultry, and salads and

spreads. FSIS treats RTE products in

which L. monocytogenes is found as

adulterated under the FMIA or the PPIA

(21 U.S.C. 453(g) or 601(m)). This

testing of approximately 7,000 RTE

product samples per year for L.

monocytogenes is an indicator of

possible public health problems, but

FSIS believes that more discriminating

approaches are in need of development.

(A comprehensive presentation on the

FSIS testing program, entitled ‘‘FSIS

Ready-to-Eat (RTE) Sampling in

Transition,’’ is available from the FSIS

Docket Room.)

During the late 1980’s, L.

monocytogenes emerged as a problem in

deli meats and other processed food

products. FSIS and the Food and Drug

Administration (FDA) worked with

processing plants to improve their

procedures and emphasized the ‘‘zero’’

tolerance (no detectable level of viable

pathogens permitted) for the pathogen

in RTE products. Between 1989 and

1993, the rate of illness from L.

monocytogenes declined 44 percent.

This reduced incidence of foodborne

listeriosis remained level until recently.

In the fall of 1998, state health

departments and the CDC began

investigating an increased number of

reported cases of illness due to L.

monocytogenes. CDC and state and local

health departments identified the

vehicle of transmission as hotdogs and

possibly deli meats produced by one

manufacturer under many brand names.

On December 22, 1998, in response to

reports of illness, the manufacturer

voluntarily recalled specific production

lots of these products that might be

contaminated. Subsequently, CDC and

FSIS investigators isolated the outbreak

strain of L. monocytogenes from an

opened and a previously unopened

package of hotdogs manufactured by

one plant. In addition, a different strain

of the pathogen was isolated from

unopened packages of deli meats

produced at the same plant. CDC has

since reported 101 illnesses, 15 adult

deaths, and 6 stillbirths or miscarriages

associated with this outbreak.

With this outbreak in mind, on May

7, 1999, the FDA, in consultation with

FSIS, announced plans to conduct a risk

assessment to determine the prevalence

and extent of exposure of consumers to

foodborne L. monocytogenes and to

assess the resulting public health impact

of such exposure (64 FR 24661). FDA

and FSIS published this draft risk

assessment for comment on January 19,

2001 (Ref. 28, available for viewing by

the public in the FSIS Docket Room).

Significantly, it identifies certain RTE

meat and poultry products, among the

food products assessed, as posing a

relatively high health risk of listeriosis

to consumers because of potential RTE

product contamination by L.

monocytogenes.

In this document, FSIS is proposing

regulatory requirements and considering

other options to address the relatively

high risk ranking of these RTE meat and

poultry products. Significantly, the draft

risk assessment was designed to

estimate the predicted relative risk of

serious illness and death that may be

associated with consumption of

different types of ready-to-eat foods. The

draft risk assessment document, unlike

more complete risk assessments, did not

attempt to account for the level or

sources of contamination of ready-to-eat

meat and poultry products in a farm-totable approach such as during

processing in Federally inspected

facilities. Rather, the draft risk

assessment accounted for the retail

foodborne exposure to human listeriosis

(i.e., after the ready-to-eat product is out

of the control of the Federal

establishment). The data included in the

draft risk assessment were gleaned from

both international and domestic

sources, with FSIS providing a

substantial amount of data from its

various microbiological programs

associated with Federally inspected

meat and poultry. The draft risk

assessment was designed to address

data only associated with listeriosis,

providing a distinction between

foodborne illness associated with mild,

flu-like symptoms (referred to as

listerial gastroenteritis) and severe and

life-threatening outcomes (i.e.,

listeriosis). For this reason, some

Federally inspected meat and poultry

products were not addressed in the draft

risk assessment (e.g., canned meat and

poultry and partially- and fully-cooked

meat patties). Except for the canned

products and the meat patties, FSIS

believes that the risk assessment

addresses the remaining meat and

poultry products contained in this

proposed rule (i.e., frankfurters, dry/

semi-dry fermented sausages, deli

meats, and pate ́ and meat spreads).

A. Proposed Requirements for

Controlling L. monocytogenes

In the risk assessment, FDA and FSIS

note that although pasteurization or

cooking by an establishment will kill L.

monocytogenes, there is risk of

recontamination of RTE foods during

processing, after the lethality is applied

(Ref. 28, (Interpretive Summary, p. 24;

Exposure Assessment, p. 24), available

for viewing by the public in the FSIS

Federal Register / Vol. 66, No. 39 / Tuesday, February 27, 2001 / Proposed Rules 12603

3Although pate and meat spreads also are

identified in the draft FDA/FSIS risk assessment as

having high predicted relative risk of causing

listeriosis on a per serving basis, much of the

reported foodborne outbreaks are associated with

foreign populations. However, FSIS is aware of one

foodborne outbreak in the U. S. involving pate

produced in a federally inspected facility in 1999.

In this outbreak, pate was prepared by cooking the

product in open containers and then over-wrapped

with film. Product was then distributed to multiple

states and sold in gourmet shops. The pate was

implicated as the food vehicle for L.

monocytogenes. L. monocytogenes was cultured

from an unopened package of pate at retail. FSIS

was not able to determine whether L.

monocytogenes was present in the unopened

package as a consequence of underprocessing (i.e.,

inadequate lethality) or post-lethality

contamination.

Docket Room). Significantly, FDA, FSIS

and other authors point out, that deli

meats in particular are most likely to be

recontaminated by L. monocytogenes

after cooking, during processing such as

slicing (Ref. 28 (p. 167); Ref. 32; Ref. 33;

all available in the FSIS Docket Room),

although no data were available to

distinguish between the risks of slicing

product in a retail environment rather

than an official establishment.3

FSIS is proposing to require that all

establishments that produce RTE meat

and poultry products conduct

environmental testing of food-contact

surfaces for Listeria spp., after lethality

treatment and before final product

packaging, unless they have identified

L. monocytogenes as a hazard

reasonably likely to occur and so have

incorporated into their HACCP systems

one or more controls validated to

eliminate it from their products. This

testing will verify that an

establishment’s Sanitation Standard

Operating Procedures (Sanitation SOPs)

are preventing direct product

contamination by L. monocytogenes

after the lethality treatment, thus

addressing the risk assessment assertion

that RTE foods often are recontaminated

by L. monocytogenes after lethality is

applied.

After an establishment finds one of its

food contact surfaces to be positive for

Listeria spp., it must take corrective

actions defined in its Sanitation SOP

that must include product testing, as

well as any other activities that it deems

necessary to determine and demonstrate

that the affected lot or lots of product

are not adulterated with L.

monocytogenes. The establishment must

have in place procedures: to determine

which lots of product might be affected;

to hold, sample, and test that product;

and to dispose of affected product

appropriately.

Establishments that have identified L.

monocytogenes as a hazard reasonably

likely to occur in their HACCP plans

and that have consequently established

CCPs for L. monocytogenes would be

exempt from this mandatory testing

requirement. For example,

establishments that produce thermally

processed, commercially sterile,

hermetically-sealed (canned) products

should be relatively unaffected by this

proposed requirement. Neither should

many other establishments that produce

meat and poultry products that receive

lethality treatment in their final

packaging, such as beef cooked in an

impervious bag. In most cases, these and

similar establishments would need only

to modify their HACCP plans to reflect

that L. monocytogenes is likely to occur

at some point during their processing,

but their existing CCPs for lethality

would eliminate the pathogen.

FSIS believes that L. monocytogenes

contamination is reasonably likely to

occur in the production of all RTE meat

and poultry products. On May 26, 1999,

FSIS published in the Federal Register

a Notice advising manufacturers of RTE

meat and poultry products of the need

to reassess their HACCP plans to ensure

that the plans are, in fact, adequately

addressing L. monocytogenes (64 FR

28351). If this reassessment revealed

that L. monocytogenes was a hazard

reasonably likely to occur in an

establishment’s production process, the

Notice stated that the establishment

must address the hazard in its HACCP

plan.

FSIS acknowledges, however, that

there may be certain processing

environments in which L.

monocytogenes is not a hazard

reasonably likely to occur. In such

environments, verification through

testing that the establishment’s

Sanitation SOP is controlling Listeria

spp. would be necessary, at a minimum.

Notably, Tompkin, et al., have

recommended plant-wide

environmental testing that

* * * should focus on a non-pathogenic

indicator such as Listeria spp. or Listeria-like

organisms * * * , because these organisms

will be found more frequently in the

environment than L. monocytogenes and

because test results are available more

quickly.

(Ref. 29, available for viewing by the public

in the FSIS Docket Room)

FSIS agrees, although the Agency is

proposing to require only the testing of

food contact surfaces. Were an

establishment to find Listeria spp. on a

food contact surface, that finding would

be indicative of a sanitation problem

that could cause product adulteration,

even though the contaminant on the

surface may not be L. monocytogenes.

FSIS is proposing to require that

establishments without HACCP controls

for L. monocytogenes test food contact

surfaces for Listeria spp. at one of the

following frequencies, depending on

establishment size:

• If the plant is large, at least four

tests, per line, per month;

• If the plant is small, at least two

tests, per line, per month;

• If the plant is very small, at least

one test, per line, per month;

FSIS is proposing to employ the same

Small Business Administration (SBA)

size standards that it used to determine

the implementation dates for its

HACCP/Pathogen reduction final rule.

Large establishments would be defined

as all establishments with 500 or more

employees. Small establishments would

be defined as all establishments with 10

or more employees but fewer than 500.

Very small establishments would be

defined as all establishments with fewer

than 10 employees or annual sales of

less than $2.5 million.

These frequencies ensure a very

minimal amount of testing and, because

they are progressive, mitigate some of

the economic impact on small

businesses. FSIS has not been able to

correlate risk of product contamination

with production volume or

establishment size. However, assuming

that large establishments produce a

greater volume of product than do small

establishments, and that a large

insanitary establishment would be more

likely to contaminate more product and

thus pose more risk to the public health,

FSIS is proposing to require large plants

to test more often. Because these

frequencies are not based on research

but represent what the Agency believes

to be minimal levels, FSIS requests

comment on these proposed testing

frequencies, their efficacy in preventing

product adulteration, and the costs to

industry. FSIS also specifically solicits

information the current state of

knowledge about the relationship

between Listeria spp. on food contact

surfaces and L. monocytogenes on the

product; the appropriate timing of the

test (pre-start-up or post-start up),

seasonality and other risk based

considerations that might be important

in creating effective testing protocols;

and, the testing methodologies that are

currently available and the current

practice and use of the tests by industry

or others Agencies. FSIS will use the

information to develop testing

frequencies and methodologies that

protect the public health, while

providing flexibility to establishments.

FSIS plans to hold one or more

technical conferences during the

comment period for this proposed rule,

at which these testing issues and other

can be discussed. FSIS plans to provide

for discussion of the latest testing

12604 Federal Register / Vol. 66, No. 39 / Tuesday, February 27, 2001 / Proposed Rules

methodologies, including those used by

other Federal Agencies and industry, as

well as an ongoing ARS study on the

testing of intact RTE product for L.

monocytogenes.

FSIS is proposing to require that

establishments take certain actions after

food contact surfaces test positive for

Listeria spp. After an establishment

finds one of its food contact surfaces to

be positive for Listeria spp., it must take

the corrective actions defined in its

Sanitation SOP. According to

§ 416.15(a), Sanitation SOP corrective

actions may include ‘‘procedures to

ensure appropriate disposition of

product(s) that may be contaminated,

restore sanitary conditions, and prevent

the recurrence of direct contamination

or adulteration of product(s).’’

The presence of Listeria spp. may be

indicative of serious sanitation

problems, especially if positive findings

recur. Further, Listeria spp. positives on

food contact surfaces indicate a

potential for product adulteration by L.

monocytogenes. Therefore, an

establishment’s corrective actions

following a positive must include

product testing and any other activities

that it deems necessary to determine

and demonstrate that the affected lot or

lots of product are not adulterated with

L. monocytogenes. The establishment

must have in place procedures: to

determine which lots of product might

be affected; to hold, sample, and test

that product; and to dispose of affected

product appropriately. FSIS

acknowledges that some establishments

would have to modify their Sanitation

SOP corrective actions to include these

elements.

FSIS requests comments on the

proposed testing provisions and any

data that would support the approach

proposed. FSIS requests comments

concerning whether Listeria positive test

results on different food contact surfaces

should be treated differently (e.g.,

positives on food contact surfaces that

have undergone listericidal treatment

versus other food contact surfaces). FSIS

also requests comments on whether it

should establish more specific

requirements regarding product

sampling and testing following a finding

of Listeria spp. on a food contact

surface. And, FSIS request comment on

whether it should allow establishments

that find Listeria spp. on a food contact

surface to determine if the positive

sample is in fact L. monocytogenes

before having to initiate product testing.

If a sampled lot is found to be positive

for L. monocytogenes, and is already in

commerce, it will be subject to recall.

Further, if product is found to be

positive for L. monocytogenes, the

establishment likely will need to

establish controls within its HACCP

plan for L. monocytogenes. Also,

reoccurring positives for non-pathogenic

Listeria spp. may indicate that the

establishment has a serious sanitation

problem, even if L. monocytogenes is

never found. FSIS enforcement action

will vary depending on the

establishment’s efforts to correct its

sanitation and processing problems and

its disposition of affected product. FSIS

acknowledges that establishments that

develop one or more CCPs to control L.

monocytogenes would not necessarily

be testing for Listeria spp. to verify the

efficacy of their Sanitation SOPs and

requests comments on this issue.

The two provisions for Listeria control

contained in this proposed rule (i.e.,

Sanitation SOPs and HACCP) require

specific daily action regarding controls

to ensure product is not adulterated.

FSIS does not, at this time, consider

control programs outside of Sanitation

SOPs and HACCP to be sufficient for

controlling hazards associated with

post-lethality contamination with

Listeria in the manufacturing of RTE

meat and poultry products

microbiological results and

documentation of corrective and

preventive actions generally are not

provided to FSIS. FSIS has received a

petition from a group of industry

organizations regarding the issue of

prerequisite programs. FSIS will address

this issue separately from this proposed

rule. In addition, FSIS will be further

addressing this issue as part of its

response to an Office of Inspector

General report on HACCP

implementation (Ref. 35, available in

the FSIS Docket Room and at the FSIS

web page, http://www.fsis.usda.gov).

With any final action FSIS will

publish guidance to establishments

regarding testing frequencies and

methodologies and appropriate

corrective actions following foodcontact surface positives. FSIS also will

publish guidance regarding available

listericidal interventions establishments

can implement as CCPs. FSIS expects to

make draft guidance documents

available after publication of this

proposed rule and as information

becomes available in order to provide

establishments with appropriate

guidance regarding sampling and testing

to verify sanitation procedures. FSIS

will consider comments on this draft

guidance in developing any final

regulations. These draft guidance

materials will be clearly identified as

guidance materials and not as regulatory

requirements. FSIS expects to post these

guidance materials to the FSIS web page

(http://www.fsis.usda.gov) and will

make the documents available free of

charge via the Constituent Update (see

section XIV Additional Public

Notification) and the FSIS Docket Room.

Eventually, FDA and FSIS may allow

establishments to treat RTE products

with ionizing radiation. If applied

within a HACCP system, irradiation

could eliminate L. monocytogenes from

a RTE product. FSIS also is aware that

industry is developing edible,

antimicrobial coatings that could be

applied to RTE meat and poultry after

cooking or other lethality treatments.

However, FDA has not yet approved any

of these coatings for meat and poultry.

FSIS also will make available its

directives to inspection personnel that

will explain how to verify whether an

establishment has implemented a

testing regime sufficient to verify the

efficacy of Sanitation SOPs in

preventing direct product

contamination by L. monocytogenes

prior to the effective date of any final

regulation.

Finally, FSIS notes that on January 13,

2000, it received a petition from the

Center for Science in the Public Interest

(CSPI) requesting that FSIS require all

establishments that produce RTE meat

and poultry products to conduct

environmental testing for Listeria spp.

and product testing for L.

monocytogenes. FSIS will respond to

this petition completely along with

other public comments submitted in

response to this proposal. CSPI also

requested that FSIS require RTE

products produced by establishments

without CCPs for L. monocytogenes to

bear warning labels. FSIS discusses this

request in the following section and also

will respond more completely in any

final action that stems from this

proposal.

B. Shelf-Life and Labeling

In the petition discussed above, CSPI

also requested that FSIS require

establishments that have not

incorporated microbial testing for L.

monocytogenes into their HACCP plans

to label their products so as to alert

‘‘consumers that the products may be

contaminated and should not be eaten

by at-risk consumers without

reheating.’’ FSIS will respond to this

petition fully in any final action

stemming from this proposed rule.

FSIS considered, but did not propose

in this document, the option of

requiring that the labeling of certain

RTE meat and poultry products state the

product’s shelf-life, and that shelf-life be

based on product safety (‘‘use-by’’ date

labeling). If after processing, a RTE

product that could support growth of L.

monocytogenes were to be

Federal Register / Vol. 66, No. 39 / Tuesday, February 27, 2001 / Proposed Rules 12605

recontaminated by even a single cell of

the pathogen, that cell could multiply

during storage at refrigeration

temperatures to levels that could pose a

risk of illness to vulnerable individuals

(e.g., pregnant women, the elderly, or

the immunocompromised). ‘‘Use-by’’

date labeling may provide further

reductions in risk of listeriosis if the

labeling increases the likelihood that

high-risk RTE products would be

consumed before very low levels of L.

monocytogenes, undetectable at the

establishment, could grow to dangerous

levels.

FSIS is not proposing to require ‘‘useby’’ dates on the labels of any RTE

products at this time because further

information regarding the potential

effects of use-by date labeling is needed.

For instance, there is sparse information

on current consumer understanding of

use-by date labeling, the likelihood that

consumer practices will change, and on

the effect of changes in consumer

behavior on listeriosis cases. Similarly,

FSIS currently does not possess all the

data necessary to assess the reduction in

risk that will occur from this change.

Also, FSIS does not have information

concerning how use-by date labeling

would affect the production and

shipment patterns of labeled ready-toeat meat and poultry products and the

structure of the industry. FSIS requests

comments on all of these issues and on

the feasibility of requiring ‘‘use-by’’ date

labeling on RTE meat and poultry

products. Significantly, FDA and FSIS

will present ‘‘use-by’’ date labeling

issues to NACMCF for their review.

FSIS has conducted a more thorough

analysis of use-by date labeling in

Appendix 1, Compliance with Executive

Order 12866, under the ‘‘Alternatives’’

section.

Related to ‘‘use-by’’ date labeling is

the issue of consumer preparation of

hotdogs and similar RTE foods. In the

draft risk assessment, FSIS and FDA

state that ‘‘the factor that has the

greatest effect on the predicted health

impact of frankfurters is the extent of

post-retail reheating by the consumer’’

(Ref. 28 (p. 161); Ref. 33; Ref 34; all

available in the FSIS Docket Room).

Obviously, testing for L. monocytogenes

in the establishment will not directly

affect consumer preparation of

frankfurters or other RTE foods.

However, if in-plant testing verifies that

establishments are effectively

preventing the contamination of

frankfurters and other RTE products by

L. monocytogenes, consumer

preparation or handling of these RTE

products will no longer be so

inappropriately crucial to ensuring their

safety. Furthermore, once FSIS is more

confident that establishments are

adequately addressing the safety of their

RTE products, especially for frankfurters

and deli meats, throughout the shelf-life

of their products, FSIS will consider

modifying its consumer message to

vulnerable populations and remove the

current recommendation for these

populations to either not consume these

RTE products or to fully re-cook these

products before consuming them.

Finally, as discussed below, FSIS is

proposing that the labeling of RTE

products state that the product requires

refrigeration after opening, as

applicable. Current regulations require

that labels of perishable products

include such instructions, but the

Agency is proposing to expand the

required label instructions to include

RTE shelf-stable products that require

refrigeration after opening. FSIS also

considered proposing to change the

‘‘keep refrigerated’’ and the ‘‘refrigerate

after opening’’ statements (see proposed

in §§ 317.2(k) and 381.125(a)) to reflect

the guidance developed by FDA on

February 24, 1997 (62 FR 8248). In the

guidance, these statements were

modified to read ‘‘Important Must Be

Kept Refrigerated to Maintain Safety’’ or

‘‘Important Must Be Refrigerated After

Opening To Maintain Safety.’’ FDA

provided this guidance in response to

the recommendations from the

NACMCF, the National Food Processors

Association, the Association of Food

and Drug Officials, and the CDC

regarding the labeling of foods that need

refrigeration. FDA stated in this policy

document that ‘‘[t]his guidance, which

represents FDA’s policy on adequate

safe handling instructions for food,

should reduce the likelihood of

temperature abuse of certain foods by

consumers, and it is intended to reduce

the potential for foodborne illness and

death.’’ FSIS is not proposing to require

these provisions because further

information regarding the potential

effects of this labeling is needed. FSIS

requests comment on the statements and

their appropriateness for RTE meat and

poultry products which are not shelf

stable.

VI. Thermally-Processed, Commercially

Sterile Products

Thermally-processed, commercially

sterile meat and poultry products

generally have a water activity above

0.85 and have received a thermal

process either before or after being

packed in a hermetically sealed

container. They are typically canned,

although other types of packaging can

be used. The thermal process renders

the product shelf-stable and

commercially sterile, that is, free of

microorganisms capable of growing in

the product in nonrefrigerated

conditions (temperatures over 50 °F or

10 °C), under which the product will be

held during distribution and storage,

until consumed.

Sections 318.300 to 318.311 and

381.300 to 381.311 of the regulations

prescribe the exact means by which

official establishments must produce

thermally processed, commercially

sterile meat and poultry products. These

regulations include detailed

requirements regarding containers and

container closures, equipment

specifications and operations,

measurements and instrument

calibration, recordkeeping and record

review, corrective actions in the case of

processing deviations, finished product

inspection, personnel training, and

product recalls. They also require that

official establishments implement

process schedules validated to render

treated meat and poultry commercially

sterile and shelf-stable. These process

schedules must be developed or

validated by processing authorities,

persons or organizations with expert

knowledge of thermal processing

requirements for foods packaged in

hermetically sealed containers.

Processors that produce thermally

processed, commercially sterile meat

and poultry products also must meet all

other regulations applicable to meat and

poultry establishments, such as

sanitation and HACCP requirements.

Significantly, however, under

§ 417.2(b)(3), FSIS exempts producers of

thermally processed, commercially

sterile products from addressing in their

HACCP plans ‘‘food safety hazards

associated with microbiological

contamination.’’ FSIS granted this

exemption in response to comment on

the proposal to require HACCP systems:

FSIS agrees that the microbial hazards

associated with canned meat and poultry

products are eliminated by complying with

the regulations in 9 CFR Secs. 318.300–311

and 381.300–311. These regulations are

based on HACCP concepts and provide for

the analysis of thermal processing systems

and controls to exclude microbial hazards.

Accordingly, the final rule provides that

HACCP plans for thermally processed/

commercially sterile products do not have to

address the food safety hazards associated

with microbiological contamination if the

product is produced in accordance with the

canning regulations. However, because the

current regulations exclusively address

microbial hazards, processors of canned

meat, meat food and poultry products must

develop and implement HACCP plans to

address chemical and physical hazards that

are reasonably likely to occur.

(61 FR 38824)

12606 Federal Register / Vol. 66, No. 39 / Tuesday, February 27, 2001 / Proposed Rules

The regulations governing the

processing of thermally processed,

commercially sterile meat and poultry

products are, in a sense, a prescribed

HACCP system that official

establishments must implement along

with controls to address other hazards

not addressed in those regulations.

Maintaining this prescriptive regulatory

approach to a single category of meat

and poultry products, however, is

inconsistent with FSIS’s other

regulatory initiatives intended to grant

industry maximum flexibility to

innovate in processing, while clarifying

industry’s responsibility and

accountability for the safety of meat and

poultry products. Therefore, FSIS is

proposing to replace the prescriptive

regulations governing thermally

processed, commercially sterile

products with performance standards.

FSIS is also proposing to remove

§§ 320.2(b)(6) and 381.175(b)(3) because

they refer to recordkeeping

requirements in the canning regulations

that FSIS is proposing to eliminate. FSIS

has discussed this proposed action in

previous documents, including the final

rule that established the HACCP

requirements:

The current canning regulations contain

numerous prescriptive features, including

extensive FSIS involvement in the decision

making process, that are inconsistent with

the philosophy underlying HACCP. In the

advance notice of proposed rulemaking

‘‘FSIS Agenda for Change: Regulatory

Review’’ (60 FR 67469; December 29, 1995),

FSIS stated its intention to convert the

canning regulations to performance

standards, which are more consistent with

HACCP.

(61 FR 38824)

FSIS is proposing lethality

performance standards to ensure the

elimination or control of the pathogen

C. botulinum in thermally processed,

commercially sterile meat and poultry

products. FSIS also is proposing a

revised requirement ensuring the

commercial sterility of these products.

This requirement is consistent with the

existing shelf-stability/commercial

sterility definitions in § 318.300(u) and

381.300(u) and the FDA regulations for

commercial sterility of canned products

contained in 21 CFR 113.3(e).

A. Lethality

FSIS is proposing different lethality

performance standards, depending on

whether the product is a low-acid

product or a product in which pathogen

growth is controlled by acidification or

factors other than the thermal process.

A low-acid, thermally processed,

commercially sterile product is a

canned or other hermetically sealed

product in which any component has a

pH value above 4.6 and a water activity

above 0.85. Such products include

canned poultry and canned uncured

meat products, such as beef stew and

chili con carne, and certain canned

cured meats, such as vienna sausages

and corned beef. An acidified thermally

processed, commercially sterile product

is a canned product that has been

formulated or treated so that every

component of the finished product has

a pH of 4.6 or lower, usually within 24

hours after the completion of the

thermal process, but sometimes longer.

Such products include spaghetti sauce

with meat and meat with tomato sauce.

In addition, there are some canned,

hermetically sealed products in which

pathogen growth is controlled by factors

other than the thermal process, such as

a heat treatment in combination with

salt or nitrite (e.g., canned luncheon

meat).

FSIS is proposing to require that an

establishment’s process for producing a

low-acid canned product result in a

probability of 10–9 or less that there are

spores of C. botulinum in a container of

the product that are capable of growing,

assuming an initial load of ≤ 1000

spores per container. Alternatively, the

establishment may achieve a 12-log10

reduction of C. botulinum. A process

carried out for a certain number of

minutes at a given temperature that

reduces C. botulinum by a factor of 12

decimal units, often referred to in the

canning industry as a ‘‘botulinum

cook,’’ is one that meets a 12-log10

standard, also known as a 12-D

standard. A 12-D process has been

demonstrated to be sufficient to destroy

C. botulinum in a low-acid canned

product. Under this proposal, the level

of safety that a process other than a 12-

D process would have to achieve would

be a probability of 10–9 or less of any C.

botulinum spores in a container of the

product that are capable of growing,

assuming an initial load of ≤1000

organisms.

The 12-D concept arose from studies

on the thermal resistance of C.

botulinum conducted in the early 1920’s

by scientists of the National Canners

Association (predecessor of the National

Food Processors Association). These

scientists inoculated a phosphate buffer

with spores of the most heat-resistant

strain of the organism then known. They

determined, by extrapolating from the

exponential survival curve for the

organism, the temperature and duration

of the heat process necessary to reduce

the population from 6 × 1011 spore/unit

to less than one spore/unit. Subsequent

studies on products inoculated with C.

botulinum and other organisms

essentially confirmed the results of

these studies.

These products undergo a botulinal

cook to achieve an acceptable safety

level. It should be noted that the

intensity of the process is not related to

the actual number of C. botulinum

organisms that may be in the product.

That number is usually very low in a

meat product (less than a spore per

kilogram). So the 12-D process provides

a tremendous safety margin to

consumers.

The level of safety achieved by a 12-

D process in low-acid canned products

is understood by thermal processing

experts to be a 10–9 probability of any

live botulinum organisms (Refs. 30–31,

available for viewing by the public in

the FSIS Docket Room). That means that

the odds are one in a billion that a can

is contaminated with the organism. This

result is arrived at by assuming that a

process that reduces botulinum spores

by 10–12—a 12-D process—is applied to

a test pack of product inoculated with

103 spores per unit. The probability that

any containers that are subjected to the

process harbor spores capable of

growing is 10–9. Thus, FSIS is proposing

to require that establishments producing

low-acid products achieve a probability

of 10–9 or less that there are spores of

C. botulinum in a container that are

capable of growing or a 12-log10

reduction of C. botulinum.

FSIS is proposing to require that the

processing of acidified low-acid

products and of some cured products

and other canned products in which

pathogen growth is controlled by factors

other than the thermal process, prevent

multiplication of C. botulinum. For

these products, processing (formulation

and environment) must prevent growth

rather than achieve any specific decimal

reduction of C. botulinum. Therefore,

there can only be one level of

performance for acidified low-acid

products and other thermally processed,

commercially sterile products in which

pathogen growth is controlled by factors

other than the thermal process—

prevention of C. botulinum

multiplication. However, the prevention

of multiplication can be achieved by a

variety of methods.

Acidified low-acid meat and poultry

products are generally acidified by

ingredients, such as tomato sauce, or by

additives, such as glucono-delta-lactone,

which increase the acidity (i.e., lower

the pH) of the products. The acidity of

these products (pH at or below 4.6) is

sufficient to prevent the germination of

C. botulinum and other bacterial spores.

The heat processing of these products

does not include a botulinum cook or

retort but is achieved at pasteurizing

Federal Register / Vol. 66, No. 39 / Tuesday, February 27, 2001 / Proposed Rules 12607

temperatures below 100 °C. (212 °F.)

and is sufficient to kill or inactivate

molds, yeasts, and vegetative bacterial

cells. This processing is important

because, if canned acidified foods are

contaminated by yeast or mold, the pH

of the foods could be raised above 4.6,

thus providing an environment for

possible C. botulinum growth. These

products—spaghetti sauce, for

example—can be heat-treated before

being placed in a container (i.e., hotfilled) rather than retorted and still

achieve commercial sterility.

Other thermally processed,

commercially sterile products can be

rendered commercially sterile by a heat

treatment in combination with other

factors. For example, the shelf-stability

of canned luncheon meat is a combined

effect of heat treatment, the presence of

nitrite and salt, and a low preprocessing level of C. botulinum. A 10-

percent salt concentration or about 2

tenths of a percent of nitrite in the

product formulation is usually

considered sufficient to inhibit growth

of the organism. The shelf-stability of

dried meat-filled pasta results from a

heat treatment and a water activity of

less than 0.92 in the product. (Water

activity is a measure of free moisture, or

water available for microbial growth, in

a food; the lower the number, the less

moisture.) C. botulinum and other

spore-forming organisms cannot grow at

water-activity levels below 0.93. The

heat treatment of these products

destroys the vegetative cells of both

pathogenic and nonpathogenic

organisms, and the outgrowth of spores

is prevented by the other inhibiting

factors.

B. Commercial Sterility

FSIS also is proposing a specific

requirement that all thermally

processed, commercially sterile

products, in fact, be commercially

sterile and hermetically sealed. This

requirement is consistent with the

existing shelf-stability/commercial

sterility definitions in § 318.300(u) and

381.300(u) and the FDA regulations for

commercial sterility of canned products

contained in 21 CFR 113.3(e). A

commercial sterility requirement is

necessary to protect against both foodsafety-related and non-food-safetyrelated forms of contamination.

Product that has undergone more

processing than necessary to protect

health, but less than necessary for

commercial sterility, is safe, but it may

not be stable. The stability of the

product is usually determined by

incubating the product for a certain time

at a given temperature (e.g., 10 days at

95±5°F), then sorting 100 percent of the

product to locate any swelling or

abnormal-appearing containers.

Products that are shown to have

undergone less processing than

necessary to protect health are

potentially hazardous and are removed

from commerce.

The proposed commercial sterility

requirement would mean that the

process for a canned product, in

addition to reducing or inactivating C.

botulinum spores, would have to ensure

a reduction or inactivation of sporeforming organisms sufficient to

guarantee commercial sterility. A

process that ensures a 10–9 probability

of contamination by C. botulinum

spores will not provide the same

probability of destruction of the most

heat-resistant mesophilic (optimum

growth, 20–45°C) anaerobes, such as

Clostridium sporogenes, or thermophilic

(optimum growth, 50–65°C) organisms,

such as B. stearothermophilus.

Recommended processes for preventing

contamination by such nonpathogenic

organisms typically ensure a probability

of no spore-forming units in the range

of 10–6. FSIS is proposing a general and

not a quantitative standard for

commercial sterility in this document

but requests comment on whether a

quantitative standard is necessary.

FSIS considers a commercial sterility

standard to be appropriate, among other

reasons, because the Agency is obligated

under the statutes it enforces to

administer programs aimed at

preventing all forms of adulteration of

meat and poultry products. The

Agency’s current thermal processing

regulations are intended to ensure that

canned and other thermally processed

products are not adulterated.

Hermetic sealing of a container

protects the product and prevents

microorganisms or other potential

contaminants from entering the

container. If the container seal is

inadequate, the product may no longer

be microbiologically stable. C.

botulinum or spoilage organisms could

contaminate the product during

container cooling or storage. The

product could become adulterated

because of spoilage, an economic

concern, or because of C. botulinum, a

public health concern. For this reason,

FSIS considers appropriate, and is

proposing, a hermetic sealing

requirement. In § 430.5(c), FSIS is

proposing that the seal be airtight to

protect the contents of the container

from the entry of microorganisms.

C. Training

Several industry groups and other

interested parties have expressed

reservations concerning any

replacement of the existing regulations

for thermally processed, commercially

sterile products with performance

standards. The complexity of the

canning process, as well as the

virulence of C. botulinum toxin which

can form in canned products, have been

cited as reasons for maintaining the

existing, prescriptive regulations.

Significantly, FSIS is proposing to

retain, in new § 430.5(d), the

requirement that all operators of

processing systems for commercially

sterile meat and poultry products and

container closure technicians be under

the direct supervision of a person who

has successfully completed a school of

instruction that is generally recognized

as adequate for training supervisors of

canning operations. FSIS specifically

invites comment as to whether and in

what form the existing requirements for

thermally processed, commercially

sterile meat and poultry products

should be retained. If the Agency does

replace the current regulations with the

proposed performance standards, it

plans to issue a revised version of the

current regulations as compliance

guides for industry.

VII. Elimination of Trichina

Treatment Requirements

FSIS also is proposing to remove the

provisions for the prescribed treatment

of pork and of products containing pork

to destroy trichina (Trichinella spiralis)

under § 318.10. FSIS requires

establishments to eliminate trichina

from numerous RTE products under

these regulations. If this proposal is

made final, the specifically prescribed

treatments will be unnecessary, since

compliance with the proposed lethality

performance standards should also

render RTE products free of trichina.

With regard to heat-treated, RTE

products containing pork, the required

treatment to destroy trichina would no

longer be needed because if the process

used meets the proposed performance

standards for Salmonella, the process

should eliminate any live trichina. For

dried, salt-cured, or fermented products,

the implementation of the lethality

requirements for Salmonella and E. coli

0157:H7 would also likely destroy

trichina. However, because there are no

published studies comparing the

lethalities of Salmonella or E. coli

0157:H7 to the destruction of trichina in

dried, salt-cured, or fermented products,

the Agency cannot state with absolute

certainty that the proposed lethalities

for these products would also destroy

any live trichina. Thus, if the

establishment identifies trichina as a

hazard reasonably likely to occur, the

establishment would have to ensure that

12608 Federal Register / Vol. 66, No. 39 / Tuesday, February 27, 2001 / Proposed Rules

the process used effectively eliminates

this hazard.

Several products that are not RTE also

must be treated to destroy trichina

under § 318.10. FSIS is proposing to

remove the trichina treatment

provisions for these products because

they represent overly prescriptive

provisions that are contrary to HACCP.

By removing these provisions for all

products, the Agency would provide

establishments with flexibility to

determine whether they need to treat

the products to eliminate trichina. If an

establishment identifies trichina as a

hazard reasonably likely to occur in a

process, it must address trichina in its

HACCP plan.

The Agency prescribes trichina

treatment for certain not-RTE products

that may be eaten rare or undercooked

because of their appearance. These

products may appear to have been

cooked because they contain ingredients

such as wine, paprika, or curing agents.

Significantly, however, packages of raw

meat and poultry products must bear

the safe handling label. The safe

handling instructions regulations (9 CFR

317.2(l) and 381.125(b)) require that all

meat and poultry products that are not

RTE bear safe handling instructions on

the label. By following the ‘‘cook

thoroughly’’ portion of the safe handling

instructions, the consumer should

eliminate possible bacterial

contaminants and any trichina present

in the product. According to the FSIS

Meat and Poultry Hotline and industry

sponsored consumer surveys, the

perception that pork may be infected

with trichina continues to be a common

food safety concern to American

consumers, so FSIS has some

confidence that consumers will cook

these products thoroughly.

FSIS is examining the need for future

rulemaking to address these pork

products and other similar non-pork

products that may be eaten without

adequate cooking because of their

appearance. The Agency is considering

requiring conspicuous labeling that

would identify these products as notRTE and provide more specific

instruction to consumers regarding safe

handling and preparation.

The requirements in § 318.10 for

treating pork products that may contain

trichina originated in the early part of

the 20th Century. At that time T. spiralis

was a serious foodborne problem caused

by consumption of underprocessed

products. In response, the USDA

implemented rules that prescribed

treatments, in part based on USDA

research, to destroy trichina in RTE

products. At the time these prescribed

trichina treatments were implemented,

the causes of bacterial foodborne

illnesses were not fully characterized or

recognized. Thus, USDA was

prescribing treatments to address the

best-known foodborne hazard and

believed a trichina-free product was

indeed safe-to-eat. In subsequent

decades, as other foodborne pathogens

were recognized and characterized,

these prescriptive regulations were not

modified to address those hazards.

For example, other organisms may be

biological hazards in pork, such as

Toxoplasma gondii and Taenia solium.

These organisms must also be

eliminated from certain products,

including RTE products, in order for the

product to be safe. However, the Agency

has not prescribed the methods of

elimination of these and other similar

potential hazards in pork. FSIS has

determined that these and other

hazards, like trichina, should be

addressed under HACCP plans rather

than through prescriptive regulations.

All establishments producing

products containing pork should assess

whether trichina is a hazard reasonably

likely to occur in their processes. If it is,

they should address this hazard in their

HACCP plans. Establishments should

assess whether the product should be

treated for elimination of live trichina,

whether special cooking instructions are

necessary on the label of the product, or

whether the safe handling label is

sufficient to ensure that the product is

cooked to temperatures necessary to

eliminate any possible live trichina. The

establishment’s decision concerning

whether to treat the product for trichina

or to include special cooking

instructions on the label may be based

on how the consumer typically prepares

the product or the likelihood of the

product’s being confused with a RTE

product.

Establishments that produce pork

products should consider whether their

suppliers have taken measures to

prevent trichina infection of their herds.

FSIS has entered into an agreement with

other USDA agencies, two pork

processors, and the National Pork

Producers Council to pilot test a

program that will identify risk factors

for trichina infection and certify

production units that voluntarily adopt

practices to reduce or eliminate those

risks. Pork producers who wish to be

certified will agree to implement

management practices that prevent a

herd from becoming trichina infected.

Qualified accredited veterinarians,

trained by the USDA Animal and Plant

Health Inspection Service (APHIS), will

audit production units to ensure that

practices are being followed. APHIS will

subsequently review audit findings and,

if satisfactory, issue a Trichinae

Certification to the herd. In addition,

APHIS will track the status of all

certified herds and conduct spot audits

to ensure program integrity. Herds

owners must renew certification status

every 15 months by satisfactorily

completing another audit.

When pigs are submitted for slaughter

as trichina certified, processors will

check the APHIS database to ensure that

the premises of origin are certified and

in good standing. A representative

sample of trichina certified pigs, as

provided by the National Trichina

Certification Program Standards, will be

tested for the presence of trichina to

ensure program integrity . FSIS will

verify that processors properly check

status of pigs, test samples as required,

and maintain adequate animal

identification and records. Any label

claims that ultimately are made will be

handled through the usual FSIS label

approval process.

The pilot program began in August

2000 with the training of qualified

accredited veterinarians and enrollment

of pork producers. After the pilot is

completed (in approximately one and a

half years), the Certification program

will be made available nationally to all

pork producers and processors.

Finally, FSIS is also proposing to

remove other referential and related

provisions concerning required

treatment to eliminate trichina. The

Agency is proposing to remove all of the

following additional provisions: A

reference to the required trichina

treatment in § 303.1(f); the requirement

under § 319.106(b) that country ham

products and dry cured pork shoulder

be treated for the destruction of possible

trichina; the requirement under

§ 319.145(a)(2) that when pork muscle

tissue is combined with beef or veal, or

both, in the preparation of certain

Italian sausage products, it be treated for

the destruction of possible live trichina;

the record retention requirement under

§ 320.1(b)(7) concerning sample results

and calculation results as required by

processing procedures to destroy

trichina in § 318.10(c)(3)(iv) (Methods 5

and 6); the provision in § 325.7(a) for

including pork that has been

refrigerated to destroy trichina in the

category of products that require special

supervision between official

establishments under official seal; and

the provision under § 331.5(a)(1)(ii) that

any meat or meat food product is

adulterated if it is a RTE pork product

that has not been treated to destroy

trichina as prescribed in § 318.10.

Federal Register / Vol. 66, No. 39 / Tuesday, February 27, 2001 / Proposed Rules 12609

VIII. Other Proposed Revisions to the

Regulations

FSIS is proposing that the labeling of

RTE products state that the product

requires refrigeration after opening, as

applicable. Current regulations require

that labels of perishable products

include such instructions, but the

Agency is proposing to expand the

required label instructions to include

RTE shelf-stable products that require

refrigeration after opening.

Also, FSIS is proposing to remove the

regulations under § 318.17, 318.23, and

381.150 that require establishments not

operating under HACCP to develop

process schedules for the production of

roast beef, cooked beef, corned beef;

fully-cooked, partially-cooked, and

char-marked uncured meat patties; and

fully-cooked and partially-cooked

poultry products, respectively.

Similarly, FSIS is proposing to remove

the definitions for ‘‘process schedule’’

and ‘‘process authority’’ in Parts 301

and 381.1. These regulations were

established by the January 1999

rulemaking that also established the

pathogen reduction performance

standards for these products. At that

time, certain official meat and poultry

establishments were not yet required to

develop and implement HACCP

systems. Therefore, with these process

schedule requirements, FSIS intended

to ensure that all establishments that

developed customized processing

systems to meet the performance

standards also would develop a

validated system of process control,

similar to HACCP. As of January 25,

2000, all official establishments are

required to develop and implement

HACCP systems, so these process

schedule requirements are no longer

necessary.

IX. Scientific Information and Data

Needs

FSIS has identified additional needs

for scientific information and analytical

data that if addressed could strengthen

the scientific foundation of the rule. It

is extremely important that the

regulations be based on sound science

and common sense measures that

involve significant public comment.

FSIS requests the specific information

identified in this document. In the

section, the major data needs are

summarized.

In order to facilitate public input and

gather additional information during the

comment period for this proposed

rulemaking, FSIS plans to hold public

meetings and scientific conferences to

discuss the proposed provisions,

especially those that would require

certain establishments to conduct

environmental testing for Listeria spp.

FSIS also intends to present the

proposed testing requirements and

related scientific issues to the NACMCF

for review.

Testing for Listeria spp.

In their recent draft risk assessment

regarding L. monocytogenes, FDA and

FSIS noted that there is an opportunity

for recontamination of RTE foods by the

pathogen during processing in the plant,

after the lethality treatment is applied

and before packaging (Ref. 28).

Consequently, under the proposed

regulations, each establishment that

produces RTE meat and poultry

products will be required to test food

contact surfaces for Listeria spp. where

product is handled after lethality but

before final packaging, unless it has

established a CCP for L. monocytogenes

in its HACCP plan(s). The establishment

and FSIS will use the test results to

verify the efficacy of the establishment’s

Sanitation SOPs in preventing RTE

product contamination by L.

monocytogenes. If an establishment

finds Listeria spp. on a food contact

surface, it must take the corrective

action(s) defined in its Sanitation SOPs,

including: procedures to determine

which lot or lots of product might have

been affected; procedures to hold,

sample, and test that product for L.

monocytogenes; and procedures to

dispose of affected product.

FSIS is confident that testing of food

contact surfaces to verify that an

establishment’s Sanitation SOPs are

eliminating Listeria spp. from food

contact surfaces will result in sanitation

improvements that will lead to

reductions in the contamination of RTE

meat and poultry products by L.

monocytogenes. FSIS also is aware that

its current testing of approximately

7,000 RTE product samples per year for

L. monocytogenes is an indicator of

possible public health problems, but

that more discriminating approaches are

in need of development. However, FSIS

is not aware of any research that

correlates specific amounts or types of

testing with specific remedial actions or

reductions in contamination and

welcomes the submission of any data.

FSIS also requests comment as to

whether other types of environmental

testing, regular product testing, or some

combination may be more effective in

detecting L. monocytogenes

contamination problems.

FSIS has proposed required

frequencies of testing that ensure very

minimal levels of regular testing based

on establishment size. FSIS is aware of

no research linking volume of

production with the likelihood of

product adulteration by L.

monocytogenes, but has assumed that

insanitary establishments producing

higher volumes of RTE meat and poultry

products would be more likely to

adulterate more product and thus pose

more risk to the public health. As a

result, FSIS has proposed a progressive

series of testing frequencies so as to

protect consumers from adulterated

product. These testing frequencies also

should minimize the costs of testing

accrued by small business. FSIS

requests any data that may adjust this

assumption, suggest specific testing

frequencies, correlate contamination

risk with volume of production, or

indicate what types and frequencies of

testing for L. monocytogenes are most

effective in detecting insanitation and

possible adulteration of RTE meat and

poultry products. Also, FSIS request

data regarding the relationship between

Listeria spp. and L. monocytogenes and

how that relationship should affect any

required testing provisions; For

example, does a food contact surface

positive for Listeria spp. scientifically

necessitate product testing and what

would negative product test results

mean?

FSIS also requests data regarding the

costs and benefits of the proposed

testing provisions, as well as other

testing protocols. Considering the

number of listeriosis cases and deaths

probably attributable to the

consumption of adulterated RTE meat

and poultry products (see Appendix 1

for further discussion), FSIS believes the

public health benefits that would result

from mandatory environmental testing

could easily exceed the costs of the

testing. But, FSIS seeks any data

correlating testing, reductions in

establishment contamination, and

consequent reductions in listeriosis that

could be used to improve the Agency’s

cost/benefit analysis.

Lethality Performance Standards

FSIS is proposing lethality

performance standards for the

pathogens Salmonella and E. coli

O157:H7 derived from the Nationwide

Microbiological Baseline Data

Collection Program. Using the positive

samples in the baseline data, FSIS

derived hypothetical worst case raw

products and then determined the levels

of pathogen reduction (lethality

performance standards) that, if met,

would render these worst case raw

products ready-to-eat and unadulterated

with a specific margin of safety. FSIS

also translated the results of the

application of the lethality performance

standards into probabilities of

12610 Federal Register / Vol. 66, No. 39 / Tuesday, February 27, 2001 / Proposed Rules

remaining pathogens in finished RTE,

product. Consequently, an

establishment that demonstrates that its

incoming raw product is consistently

less contaminated than the worst case

could apply a lower lethality than

proposed, as long as it achieves the

corresponding probability of remaining

pathogens in finished RTE product.

It is possible that better data is

available for deriving hypothetical worst

case products and corresponding

performance standards. FSIS is unaware

of any human health risk assessments

that could be used to correlate changes

in the performance standards with

changes in public health benefits.

Higher or lower lethality performance

standards may be necessary in all or

specific processing contexts. FSIS

specifically requests any data that

would support requiring different

lethality performance standards to

achieve certain public health benefits.

The lethality performance standards

for Salmonella already apply to

numerous RTE meat and poultry

products and FSIS believes that many

establishments that produce RTE

products not now subject to the

proposed standards already meet them.

It is likely, however, that some

establishments will have to alter their

processing methods to meet the

proposed standards, i.e., to achieve

higher levels of lethality in their RTE

products. Further, manufacturers of RTE

meat patties now only are required to

comply with time/temperature

regulations that yield a lesser level of

lethality than what FSIS is proposing for

all RTE meat products. FSIS requests

information on the costs meat patty

manufacturers and other establishments

may accrue if required to meet the

proposed lethality performance

standards for RTE meat and poultry

products.

Stabilization Performance Standards

Also under the proposal, all RTE meat

and poultry products, other than

thermally processed, commercially

sterile products, and all partially heattreated products, must be processed so

as to prevent multiplication of toxigenic

microorganisms such as C. botulinum

and to allow no more than 1-log10

multiplication of C. perfringens within

the product. Stabilization is commonly

achieved by rapidly cooling product

after cooking. It also can be achieved by

the addition of a curing agent. These

regulatory stabilization standards

already apply to numerous RTE and

partially-heat treated meat and poultry

products.

Researchers have suggested to FSIS

that there may be some inevitable

growth of C. botulinum during a 1-log10

relative growth of C. perfringens and

therefore compliance with the proposed

zero growth standard for C. botulinum

could in fact effectively require

establishments to meet a more

restrictive standard than that for C.

perfringens. FSIS requests comment and

scientific data relative to whether the

Agency should revise the existing and

proposed stabilization performance

standard for controlling these two

pathogens, as well as data on

corresponding public health benefits.

X. Summary of the Proposed Rule

In summary, FSIS is proposing the

following requirements governing the

production of all RTE and partially heattreated meat and poultry products:

• All RTE meat and poultry products,

except for thermally-processed,

commercially sterile products, must be

processed to achieve a lethality

performance standard that indicates a

specific reduction in Salmonella.

• All fermented RTE meat and

poultry products that contain any

amount of beef, except for thermallyprocessed, commercially sterile

products, must be processed to achieve

an additional lethality performance

standard that indicates a specific

reduction in E. coli O157:H7.

• All RTE meat and poultry products,

other than thermally processed,

commercially sterile products, and all

partially heat-treated products, must be

processed so as to prevent

multiplication of toxigenic

microorganisms such as C. botulinum

and to allow no more than 1-log10

multiplication of C. perfringens within

the product.

• The processing of RTE meat and

poultry products must be validated to

achieve the reduction of other

pathogens and their toxins or toxic

metabolites necessary to prevent

product adulteration. Further,

processing must be validated to

maintain the lethality and stabilization

performance standards throughout

product shelf-life under the conditions

in which the food is stored, distributed,

and held.

• All thermally-processed,

commercially sterile meat and poultry

products must be processed to either

eliminate or control the growth of C.

botulinum, depending on the pH of the

product or other factors that affect the

growth of that pathogen. These products

also must be commercially sterile and

the container in which the product is

enclosed must be hermetically sealed.

• Each establishment that produces

RTE meat and poultry products must

test food contact surfaces for Listeria

spp. in order to verify the efficacy of its

Sanitation SOP, unless it has

incorporated one or more controls for L.

monocytogenes into its HACCP plan.

Testing frequency will be based on

establishment size. Food contact surface

positives for Listeria spp. will trigger

mandatory product testing.

• The regulations in § 318.10 that

require the elimination of trichina from

pork products will be rescinded.

XI. Compliance With Executive Order

12866

This proposed action has been

reviewed for compliance with Executive

Order 12866. Because this proposed

action has been determined to be

economically significant for purposes of

Executive Order 12866, the Office of

Management and Budget has reviewed

it.

FSIS is proposing to amend the

Federal meat and poultry inspection

regulations by establishing pathogen

reduction performance standards for all

RTE and all partially heat-treated meat

and poultry products. FSIS also is

proposing to require establishments that

produce RTE meat and poultry products

to conduct environmental testing for

Listeria spp. to verify that they are

controlling L. monocytogenes within

their processing environments.

Establishments that have developed and

implemented HACCP controls for L.

monocytogenes would be exempt from

these testing requirements. Finally, FSIS

is proposing to eliminate its regulations

that require that both RTE and notready-to eat pork and products

containing pork be treated to destroy

trichina; these requirements are

inconsistent with HACCP and some will

be unnecessary if FSIS makes final the

proposed performance standards for

RTE meat and poultry products.

This proposed action is compelled by

recent outbreaks of foodborne illness

related to the consumption of

adulterated RTE meat and poultry

products, as well as the need to provide

objective, measurable pathogen

reduction standards that can be met by

official establishments and compliance

with which can be established through

Agency inspection. Although FSIS

routinely samples and tests some RTE

products for the presence of pathogens

prior to distribution, there are no

specific regulatory pathogen reduction

requirements for most of these products.

And in regard to thermally processed,

commercially sterile (most often

canned) meat and poultry products, the

proposed standards represent regulatory

reform; they replace lengthy,

prescriptive regulations with

performance standards that provide the

Federal Register / Vol. 66, No. 39 / Tuesday, February 27, 2001 / Proposed Rules 12611

same level of food safety, as well as

increased flexibility for establishments

to customize their processes under

HACCP.

Appendix 1, published in this issue of

the Federal Register immediately

following this proposed rule, contains a

preliminary analysis required under

Executive Order 12866, including a

discussion of the need for the proposed

regulations, regulatory alternatives

considered by FSIS, and a complete

cost-benefit analysis. FSIS demonstrates

in Appendix 1 why it believes that this

proposed action would result in

benefits.

In short, if the proposed regulations

could achieve a complete elimination of

listeriosis that results from the

consumption of contaminated RTE meat

and poultry products, the expected

annual reduction in listeriosis cases and

deaths would range from 1660 cases and

331 deaths (based the draft FDA–FSIS

risk assessment and on 100 percent

program effectiveness) to 167 cases and

35 deaths (based on two independent

CDC studies and 100 percent program

effectiveness). FSIS is uncertain about

the effectiveness of its proposed testing

requirements in reducing listeriosis and

therefore unable to adequately quantify

a range of benefits. FSIS intends to use

comments and data received during the

comment period and at the planned

technical conference to refine the

proposed regulations and to better

estimate benefits. It is of course unlikely

that the proposed regulations could

achieve complete elimination of the

listeriosis that results from

contaminated meat and poultry, but

FSIS believes that the benefits of the

regulations would exceed the total costs

of all of the proposed provisions.

The two main provisions of the

proposed rule are: (1) Mandatory inplant testing for Listeria and (2)

Salmonella and E. coli O157:H7

performance standards firms must

employ as measures of process control.

Much of costs of these actions are

associated with first-year, one-time

validation pertaining to the achievement

of the performance standards and with

the incorporation of new information

into plants’ HACCP plans. These initial

costs are projected at over $6.5 million,

while annual recurring costs are

estimated at $6.2 million. Benefits are

expected to result from less

contaminated product entering

commercial channels due to increased

sanitation efforts and in-plant

verification through testing.

XII. Compliance With Regulatory

Flexibility Act of 1996

The Administrator has determined

that for the purposes of the Regulatory

Flexibility Act (5 U.S.C. 601–612), this

proposed rule will have a significant

economic impact on a substantial

number of small entities. As discussed

in the regulatory impact analysis, FSIS

estimates that the proposed performance

standards may cost small and very small

producers of jerky, hotdogs, luncheon

meat and meat patties approximately $5

million annually, about 71 percent of

the total costs of compliance associated

with these provisions.

FSIS considered not proposing to

extend the performance standards to

these products because of the possible

disproportionate economic impact on

small business. However, taking this

alternative would result in a significant

inconsistency in the Agency’s public

health policy. Most, if not all, RTE meat

and poultry products are manufactured

from the same supply of raw product

examined in the FSIS national baseline

surveys. So performance standards

derived from this baseline should be

applicable to all categories of RTE meat

and poultry products, regardless of how

they are processed. That is, all RTE

products should be required to meet the

same standard of safety.

The ‘‘Small Business Regulatory

Enforcement Fairness Act of 1996’’ (P.

L. 104–121) requires, among other

things, that

For each rule or group of related rules for

which an agency is required to prepare a

final regulatory flexibility analysis under

section 604 of title 5, United States Code, the

agency shall publish one or more guides to

assist small entities in complying with the

rule, and shall designate such publications as

‘‘small entity compliance guides’’. The

guides shall explain the actions a small entity

is required to take to comply with a rule or

group of rules. The agency shall, in its sole

discretion, taking into account the subject

matter of the rule and the language of

relevant statutes, ensure that the guide is

written using sufficiently plain language

likely to be understood by affected small

entities. Agencies may prepare separate

guides covering groups or classes of similarly

affected small entities, and may cooperate

with associations of small entities to develop

and distribute such guides.

With any final action that stems from

this proposed rulemaking, FSIS will

publish compliance guides for small

businesses. The guides will include

detailed instructions on how to comply

with the proposed performance

standards for all categories of RTE meat

and poultry products. Establishments

that wish to use the guides may

incorporate them into their HACCP

plans. Because FSIS will base its

guidance on existing research and

industry practices known to be effective,

the Agency also will consider the

processing instructions to be already

validated. That is, establishment may

follow the guidance without contracting

for or conducting additional validation.

FSIS believes compliance guides would

significantly reduce the economic

burden the proposed regulations could

place on small businesses.

FSIS is examining other options to

minimize the potential negative

economic effects of these proposed

regulations on small businesses,

including staggering the effective dates

for any final regulations, in

consideration of establishment size.

FSIS requests comment on other

measures it could take to mitigate the

economic impact of any final

regulations.

FSIS also estimates that the direct cost

of the mandatory environmental testing

provision of the proposed rule will

entirely fall on small and very small

producers. Based on the preliminary

analysis in Appendix 1, FSIS expects

that they will incur approximately $1.75

million annually (See Appendix 1 for

details on the cost estimates).

Types of Entities and Production

Affected by the Proposed Regulations

The 1997 Census of Manufacturers

identifies 1630 establishments which

could potentially be affected by the

proposed rule. In Appendix 1 and for

this analysis, these establishments are

broken down into four broad groups that

FSIS differentiated by the estimated

costs of compliance with all of the

proposed provisions. These groups are

further broken down into sub-groups

where appropriate. The main product

groups (and sub-groups, if appropriate)

are:

• Group I: Those entities that likely

will incur the greatest costs and which

are further broken down into: Sub-group

1: fermented, dried, and salt-cured RTE

meat and poultry products; Sub-group 2:

hotdogs and wieners; Sub-group 3:

cooked meat and poultry patties; and,

Sub-group 4: smoked hams and poultry

luncheon meats;

• Group II: Those entities that likely

will incur moderate costs and which are

further broken down into three types of

producers of cooked or otherwise

processed meat and poultry products

(either produced by a combo plant, meat

or poultry processor);

• Group III: those entities that likely

will incur minor costs (frozen dinners,

pizza, and other similar meat and

poultry products); and

12612 Federal Register / Vol. 66, No. 39 / Tuesday, February 27, 2001 / Proposed Rules

• Group IV: those entities that likely

will incur no costs (canned meat and

poultry products).

Almost 60 percent of all the

establishments that could be potentially

affected by the proposed rule are

classified as small (employing between

10 and 500 employees) (Table 3).

Another 32 percent fall into the very

small establishment category of

employing fewer than 10 employees

while the remaining 9 percent are

classified as large (employing more than

500 employees).

The number of establishments, the

types of products shipped, and value of

shipments of these groups are

summarized below in Table 3.

Most product groups and sub-groups

exhibit a population distribution in

which about 33% of firms are very

small, 60% are small, and less than 10%

are large. However, three product

groups differ markedly: Group II, Subgroups 2 and 3 and Group IV (rows 11,

12, and 15 in Table 3). Large

establishments play an important role in

Group II, Sub-group 2 (poultry

processors of miscellaneous RTE

products containing meat and poultry)

making up 37 percent of all their

numbers. As a consequence, the

percentage contributions to their total

numbers for both small and very small

establishments are much lower than the

all-group averages. Canners (Group IV)

also exhibit a much different population

distribution than the average: they are

dominated by small establishments,

which lowers the presence of very small

canning establishments. Finally, the

percentage of very small combination

slaughter/meat processing

establishments in Group II, Sub-group 3

have almost as high a percentage of

establishments as do the small

establishments for all groups (55 percent

of this sub-group consists of very small

establishments while the percentage of

small establishments drop to 48

percent).

TABLE 3.—NUMBER OF ESTABLISHMENTS BY SIZE WHICH MAY BE AFFECTED BY RTE RULE AND THEIR PROPORTION IN

EACH PRODUCT GROUP

Group and subgroup

Establishment size categories

Total

VS S VS+ S L

I:

1 .................................................................................... 57 (38%) 85 (57%) 142 (95%) 8 (5%) 150

2 .................................................................................... 56 (34%) 94 (56%) 150 (90%) 17 (10%) 167

3 .................................................................................... 27 (36%) 47 (62%) 74 (98%) 2 (2%) 76

4 .................................................................................... 64 (34%) 105 (55%) 169 (89%) 22(11%) 191

Sub-Total ............................................................ 204 (35%) 331 (57%) 535 (92%) 49 (8%) 584

II:

1 .................................................................................... 200 (36%) 339 (62%) 539 (98%) 12 (2%) 551

2 .................................................................................... 25 (15%) 79 (48%) 104 (63%) 60 (37%) 164

3 .................................................................................... 42 (55%) 29 (38%) 71 (93%) 5 (7%) 76

Sub-Total ............................................................ 267 (34%) 447 (56%) 714 (90%) 77 (10%) 791

III .......................................................................................... 35 (34%) 62 (59%) 97 (93%) 7 (7%) 104

IV .......................................................................................... 18 (12%) 121 (80%) 139 (92%) 12 (8%) 151

Total ................................................................... 524 (32%) 961 (59%) 1485 (91%) 145 (9%) 1630

Note: VS stands for ‘‘very small,’’ S stands for ‘‘small,’’ and L stands for ‘‘large.’’

Totals may not add due to rounding.

First-Year Total Direct Cost Impacts

Across Establishment Size by Product

Group

The total first year economic impacts

(as estimated in Appendix 1) were

broken down by product group and size.

The percentages reported in Table 4

represent the impact on each product

group as a percentage of the total

industry-wide impact. The distribution

of the economic impacts is based on

assumptions, explained in detail in

Appendix 1, concerning which groups

of industry will be affected by the

proposed performance standards, which

will be affected by the proposed Listeria

requirements, and of those affected by

the Listeria requirements, which will

choose to test for Listeria spp. and

which will choose to develop CCPs for

L. monocytogenes. Significantly, FSIS

expects that large establishments would

opt to develop CCPs for L.

monocytogenes, but that many small

and very small establishments will opt

to test for Listeria spp.

TABLE 4.—POTENTIAL FIRST-YEAR TOTAL DIRECT COST IMPACTS ACROSS ESTABLISHMENT SIZES

Group and subgroup

Across all product-types 1

VS S L Total 2

000’s $ % 000’s $ % 000’s $ % 000’s $ %

I:

1 ................................................................ 942.5 7.4 3108.4 24.6 1847.4 14.6 5898.3 46.6

2 ................................................................ 89.6 0.7 313.7 2.5 189.2 1.5 592.5 4.7

3 ................................................................ 308.3 2.4 1235.7 9.8 399.2 3.2 1943.3 15.4

4 ................................................................ 114.1 0.9 386.3 3.1 412.5 3.3 912.9 7.2

Sub-Total Group I .......................... 1454.5 11.5 5044.1 39.8 2848.3 22.5 9347.0 73.8

Federal Register / Vol. 66, No. 39 / Tuesday, February 27, 2001 / Proposed Rules 12613

TABLE 4.—POTENTIAL FIRST-YEAR TOTAL DIRECT COST IMPACTS ACROSS ESTABLISHMENT SIZES—Continued

Group and subgroup

Across all product-types 1

VS S L Total 2

000’s $ % 000’s $ % 000’s $ % 000’s $ %

II:

1 ................................................................ 307.5 2.4 1093.1 8.6 313.5 2.5 1714.2 13.5

2 ................................................................ 59.7 0.5 313.1 2.5 575.4 4.5 948.2 7.5

3 ................................................................ 64.3 0.5 99.2 0.8 70.4 0.6 234.0 1.8

Sub-Total Group II ......................... 431.6 3.4 1505.4 11.9 959.3 7.6 2896.3 22.9

III ...................................................................... 58.4 0.5 213.3 1.7 144.6 1.1 416.3 3.3

IV ...................................................................... 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00

Total ............................................... 1944.5 15.4 6762.8 53.4 3952.3 31.2 12659.6 100.00

Note: VS stands for ‘‘very small,’’ S stands for ‘‘small,’’ and L stands for ‘‘large.’’

Totals may not add due to rounding.

Matching up Percent of Establishments

With Their Share of First Year Total

Cost Impacts

The establishment data from Table 3

was broken down in a similar way as

Table 4 above. That is, they were broken

down by very small, small, and large

size categories as a percent of the total

number of establishments. This

establishment population distribution

(as reported in columns 3, 5, 7, and 9

in Table 5) was then combined with the

distribution of the first-year industrywide direct cost impacts from Table 4

(as reported in columns 4, 6, 8, and 10

in Table 5). In effect, Table 5 pairs each

product group’s percent of total

establishments with its share of total

first-year industry-wide economic

impact. For example, the bottom line in

Table 5 reveals that very small

establishments comprise 32 percent of

all RTE establishments and absorbs 15.4

percent of total first-year industry-wide

economic impact (as was reported in

Table 4).

Table 5 reveals that large

establishments, on an establishment

basis, bear a disproportionate share of

the total regulatory cost. That is, they

constitute less than 10 percent of the

establishments and yet absorb over 31.2

percent of the first year total direct cost

impacts. Most of these impacts are

incurred by large Group I

establishments, mainly to satisfy the

performance standard requirements of

the proposed rule.

TABLE 5.—PERCENT OF TOTAL ESTABLISHMENTS AND THEIR SHARE OF FIRST-YEAR TOTAL DIRECT COST IMPACTS

Group and sub-group

The percent of total establishments and total impact by establishment size

Very small Small Large All sizes

Establishments Impact Establishments Impact Establishments Impact Establishments Impact

I:

1 ................................................................ 4 7.4 5 24.6 1 14.6 10 46.6

2 ................................................................ 3 0.7 6 2.5 1 1.5 10 4.7

3 ................................................................ 2 2.4 3 9.8 0 3.2 5 15.4

4 ................................................................ 4 0.9 6 3.1 1 3.3 11 7.2

Sub-Total Group I .......................... 13 11.5 20 39.8 3 22.5 36 73.8

II:

1 ................................................................ 12 2.4 21 8.6 1 2.5 34 13.5

2 ................................................................ 1 0.5 5 2.5 4 4.5 10 7.5

3 ................................................................ 3 0.5 2 0.8 0 0.6 5 1.8

Sub-Total Group II ......................... 16 3.4 28 11.9 5 7.6 49 22.8

Sub-Total Group III ........................ 2 0.5 4 1.7 0 1.1 6 3.3

Sub-Total Group IV ........................ 1 0.0 7 0.0 1 0.0 9 0.0

Total ........................................ 32 15.4 59 53.4 9 31.2 100 100

Totals may not add due to rounding.

Per-Establishment Impact Estimates

FSIS realizes that the proposed rule

has a unique impact on each

establishment. Some establishments are

already meeting the performance

standards and some probably not; some

establishments are conducting

environmental tests for Listeria and

have a Listeria-related CCP; some do

not. The following tables attempt to put

the aggregate impact of the proposed

rule on an individual establishment

basis. This sheds additional light on the

distributional impact across

establishment size. By so doing, a

different picture on the relative impact

on different size establishments comes

into view. Keep in mind that the

estimates below are made on an affected

establishment basis, not on a purely

product group average basis.

12614 Federal Register / Vol. 66, No. 39 / Tuesday, February 27, 2001 / Proposed Rules

Performance Standards

For the 28 very small, 44 small, and

3 large establishments in Group I

potentially affected by the proposed

rule, performance standards may

necessitate that these establishments

incur an additional $40,210, $89,380

and $630,140 per firm in the first year

for each size establishment, respectively

(Table 6).

Most of these expected expenditures

reflect increased treatment costs. These

per firm costs, multiplied by the number

of affected firms, produce an industrywide, first-year cost impact of

approximately $7.1 million (Table 6).

The estimation of these costs is further

explained in Appendix 1 in the sections

entitled ‘‘A. Projected Costs Associated

with Production Adjustments’’ and ‘‘B.

Projected Costs Associated with

Performance Standard Validation.’’ FSIS

acknowledges that due to a lack of

available data, the total costs of the

proposed performance standards may be

underestimated. See the section in

Appendix 1 entitled ‘‘Uncertainty: Cost

Side’’ for further discussion of the

uncertainty around these estimated

costs.

Mandatory Testing Requirements:

Mandatory food contact surface

testing is the most difficult provision in

the proposed rule to analyze because of

the uncertainty of current practices and

how establishments will react to the

proposed rule. Major uncertainties

include: the degree to which firms will

switch to a Listeria-related CCP in their

HACCP plan and the degree to which

firms will be able to resolve their

Listeria-related problems if they present

themselves. Depending on the

individual establishment, this provision

of the proposed rule could necessitate

small establishments incurring an

additional $5,000 (to establish a Listeriarelated CCP) or an additional $3,400 in

environmental testing, and possibly as

high as a $6,200 cost to resolve any

Listeria-related problems. Large

establishments are expected to meet this

requirement by either having or

incorporating a CCP addressing Listeria

in their HACCP plan at a cost of $5000.

Very small establishment could incur an

additional $5000 cost (in CCP

validation) or an additional $840 in

environmental testing and possibly a

$3200 cost in resolving their Listeriarelated problems. Nineteen large

establishments are expected to incur an

$81,900 to implement measures to

resolve their Listeria-related problems.

Summary

In the aggregate, large establishments

incur a disproportionate share of the

total industry-wide impact. This result

is due to the volume-based costs

associated with performance standards.

On an individual establishment basis,

the proposed rule still presents a

substantial potential cost increase for

very small and small establishments.

Efforts to reduce validation costs on

CCPs addressing Listeria and

performance standards could afford this

group of establishments with great

financial relief. The treatment costs

related to the performance standards is

also an important driver in this analysis:

this cost estimate is based on limited

information at this time. Also, the

flexibility afforded producers by the

proposed rule may mean that new, more

cost-effective, technology may be

adopted in a relatively short time period

and lower these costs. Such

assumptions could not be incorporated

in this analysis at this time.

TABLE 6.—DISTRIBUTIONAL ECONOMIC COST OF PERFORMANCE STANDARDS IN PROPOSED RULE

Group and sub-group

Per establishment cost impact

(000’s $ per

establishment)

Number of establishments affected

(number)

Industry-wide impacts

(000’s $)

VS S L All VS S L All VS S L Total

I:

1 ....................................................... 45 100 650 108.4 19 28 3 50 854.15 2830.5 1731.6 5416.25

2 ....................................................... 0 0 0 0 0 0 0 0 0.00 0 0 0.00

3 ....................................................... 30 70 550 68.4 9 16 1 25 267.30 1085.7 363.0 1716.00

4 ....................................................... 0 0 0 0 0 0 0 0 0.00 0 0.00 0.00

SubTotal Group I ............................. 40.2 89.4 630.1 95.1 28 44 3 75 1121.45 3916.2 2094.60 7132.25

II:

1 ....................................................... 0 0 0 0 0 0 0 0 0 0 0 0

2 ....................................................... 0 0 0 0 0 0 0 0 0 0 0 0

3 ....................................................... 0 0 0 0 0 0 0 0 0 0 0 0

III: ............................................................ 0 0 0 0 0 0 0 0 0 0 0 0

IV: ............................................................ 0 0 0 0 0 0 0 0 0 0 0 0

Total ...................................... 40.2 89.4 630.1 95.1 28 44 3 75 1121.45 3916.2 2094.6 7132.245

Totals may not add due to rounding.

TABLE 7.—DISTRIBUTIONAL ECONOMIC COST OF ADDITIONAL TESTING ASSOCIATED WITH MANDATORY LISTERIA TESTING

PROVISION IN PROPOSED RULE.

Group and sub-group

Per establishment cost impact

(000’s $ per

establishment)

Number of establishments affected

(number)

Industry-wide impacts

(000’s $)

VS S L All VS S L All VS S L Total

I:

1 ....................................................... .84 3.4 0 2.1 46 43 0 88 38.3 142.8 0.0 181.1

2 ....................................................... .84 3.4 0 2.1 45 47 0 92 37.6 157.9 0.0 195.5

3 ....................................................... .84 3.4 0 2.1 22 23 0 45 18.1 79.0 0.0 97.1

4 ....................................................... .84 3.4 0 2.1 51 53 0 104 43.0 176.4 0.0 219.4

II:

1 ....................................................... .84 3.4 0 2.1 160 170 0 330 134.4 569.5 0.0 703.9

2 ....................................................... .84 3.4 0 2.5 20 40 0 60 16.8 132.7 0.0 149.5

3 ....................................................... .84 3.4 0 1.6 34 15 0 48 28.2 48.7 0.0 76.9

III ............................................................. .84 3.4 0 2.2 28 31 0 59 23.5 104.2 0.0 127.7

Federal Register / Vol. 66, No. 39 / Tuesday, February 27, 2001 / Proposed Rules 12615

TABLE 7.—DISTRIBUTIONAL ECONOMIC COST OF ADDITIONAL TESTING ASSOCIATED WITH MANDATORY LISTERIA TESTING

PROVISION IN PROPOSED RULE.—Continued

Group and sub-group

Per establishment cost impact

(000’s $ per

establishment)

Number of establishments affected

(number)

Industry-wide impacts

(000’s $)

VS S L All VS S L All VS S L Total

IV ............................................................. 0 0 0 0.0 0 0 0 0 0 0 0.0 0

Total ...................................... .84 3.4 0 2.1 405 420 0 825 340.0 1411.2 0.0 1751.2

Totals may not add due to rounding.

TABLE 8.—DISTRIBUTIONAL ECONOMIC COST OF HACCP VALIDATION ASSOCIATED WITH LISTERIA MONOCYTOGENES

CONTROLS IN PROPOSED RULE

Group and sub-group

Per establishment cost impact

(000’s $ per

establishment)

Number of establishments affected

(number)

Industry-wide impacts

(000’s $)

VS S L All VS S L All VS S L Total

I:

1 ....................................................... 5.0 5.0 5.0 5.0 6 14 4 24 28.5 70.8 20.00 119.3

2 ....................................................... 5.0 5.0 5.0 5.0 6 16 9 30 28.0 78.3 42.50 148.8

3 ....................................................... 5.0 5.0 5.0 5.0 3 8 1 12 13.5 39.2 5.00 57.67

4 ....................................................... 5.0 5.0 5.0 5.0 6 18 11 35 32.0 87.5 55.00 174.50

Sub-Total—Group I ............... 5.0 5.0 5.0 5.0 20 55 25 100 102.0 275.8 122.50 500.30

II:

1 ....................................................... 5.0 5.0 5.0 5.0 20 57 6 83 100.0 282.5 30.0 412.5

2 ....................................................... 5.0 5.0 5.0 5.0 3 13 30 46 12.5 65.8 150.0 228.3

3 ....................................................... 5.0 5.0 5.0 5.0 4 5 3 12 21.0 24.2 12.5 57.7

Sub-Total—Group II .............. 5.0 5.0 5.0 5.0 27 75 39 14 133.5 372.5 192.5 698.5

III ............................................................. 5.0 5.0 5.0 5.0 4 10 4 17 17.5 51.7 17.5 86.7

IV ............................................................. 0 0 0 0 0 0 0 0 0 0 0 0

Total ...................................... 5.0 5.0 5.0 5.0 51 140 67 257 253 700 332.5 1285.5

Numbers may not add due to rounding.

TABLE 9.—DISTRIBUTIONAL ECONOMIC COST OF PRODUCTION EFFECT 1 AND 2 ASSOCIATED WITH THE MANDATORY

LISTERIA TESTING PROVISIONS IN PROPOSED RULE

Group and sub-group

Per establishment cost impact

(000’s $ per

establishment)

Number of establishments affected

(number)

Industry-wide impacts

(000’s $)

VS S L All VS S L All VS S L Total

I:

1 ....................................................... 2.7 5.4 85.5 8.65 8 12 1 21 21.53 64.3 95.80 181.63

2 ....................................................... 3.0 5.9 61.6 10.6 2 13 2 23 23.96 77.5 146.71 248.17

3 ....................................................... 2.5 4.8 111.6 6.8 4 7 0 11 9.41 31.9 31.20 72.51

4 ....................................................... 4.4 8.3 116.1 19.4 9 15 3 27 39.1 122.4 357.50 519.00

Sub-Total—Group I .......................... 3.3 6.4 92.0 12.5 29 46 7 82 94 296.1 631.21 1021.31

II:

1 ....................................................... 2.6 5.1 168.8 7.7 28 47 2 77 73.1 241.1 283.5 597.7

2 ....................................................... 8.7 10.4 50.6 24.8 4 11 8 23 30.44 114.5 425.4 570.34

3 ....................................................... 2.6 6.5 82.7 9.3 6 4 1 11 15.1 26.3 57.9 99.3

Sub-Total—Group II ......................... 3.2 6.1 71.1 11.4 37 63 11 111 118.64 381.9 766.8 1267.34

III ............................................................. 3.5 6.6 129.7 13.8 5 9 1 15 17.4 57.4 127.1 201.9

IV ............................................................. 0 0 0 0 0 0 0 0 0 0 0 0

Total ................................................. 3.2 6.2 81.9 12.0 71 118 19 207 230.02 735.4 1525.20 2490.65

Totals may not add due to rounding.

XIII. Executive Order 12988

This proposed rule has been reviewed

under Executive Order 12988, Civil

Justice Reform. States and local

jurisdictions are preempted by the

Federal Meat Inspection Act (FMIA) and

the Poultry Products Inspection Act

(PPIA) from imposing any marking,

labeling, packaging, or ingredient

requirements on federally inspected

meat and poultry products that are in

addition to, or different than, those

imposed under the FMIA and PPIA.

States and local jurisdictions may,

however, exercise concurrent

jurisdiction over meat and poultry

products that are outside official

establishments for the purpose of

preventing the distribution of meat and

poultry products that are misbranded or

adulterated under the FMIA and PPIA,

or, in the case of imported articles, that

are not at such an establishment, after

their entry into the United States. This

proposed rule is not intended to have

retroactive effect.

12616 Federal Register / Vol. 66, No. 39 / Tuesday, February 27, 2001 / Proposed Rules

If this proposed rule is adopted,

administrative proceedings will not be

required before parties may file suit in

court challenging this rule. However,

the administrative procedures specified

in 9 CFR 306.5 and 381.35 must be

exhausted prior to any judicial

challenge of the application of the

provisions of this proposed rule, if the

challenge involves any decision of an

FSIS employee relating to inspection

services provided under the FMIA or

PPIA.

XIV. Risk Analysis

Section 304 of the Federal Crop

Insurance Reform and Department of

Agriculture Reorganization Act of 1994

(P.L. 103–354) requires any regulation

published by USDA concerning human

health, safety, or the environment, and

having an annual economic impact of at

least $100 million in 1994 dollars,

contain a risk assessment and costbenefit analysis. The risk assessment

and cost-benefit analysis must be

‘‘performed consistently and use

reasonably obtainable and sound

scientific, technical, economic, and

other data.’’ The USDA Office of Risk

Assessment and Cost-Benefit Analysis

(ORACBA), also established by the 1994

Act, must ensure that major rules

include such analyses.

Although the initial costs of

compliance with the proposed

regulations may be less than $100

million, they also may exceed $100

million. FSIS estimates that over an

undetermined, but relatively short

period of time, the benefits of the

regulations also should exceed this

amount. In the economic analysis

required under E. O. 12866, FSIS

estimates that after 10 years, 868 to

8,632 cases of listeriosis may be

eliminated as a result of this rule (see

Appendix 1). Consequently, FSIS

believes that the proposed regulations

are subject to the Reorganization Act

requirements for a risk assessment and

cost-benefit analysis.

FSIS and ORACBA have agreed that

the cost-benefit and economic impact

analyses that FSIS has performed for

this proposed rule, as required by E.O.

12866 and the Regulatory Flexibility

Act, satisfy the cost-benefit analysis

requirements of the Reorganization Act.

Regarding the required risk assessment,

FSIS is presenting several different

documents to support different

provisions of the proposed regulations.

To support the proposed lethality

performance standard for the

elimination of E. coli O157:H7 from

fermented RTE products that contain

beef, FSIS cites its draft ‘‘Risk

Assessment of the Public Impact of

Escherichia coli O157:H7 in Ground

Beef’’ (Ref. 1, available for viewing by

the public in the FSIS Docket Room). As

discussed above, this document shows

that levels of E. coli O157:H7 in cattle

represent a risk to consumers of ground

beef, and that, unless there is a

significant intervention on the farm or

during processing, the risk is likely to

remain. Use of this draft risk assessment

to develop the performance standard for

fermented products containing beef is

discussed above in detail in the sections

‘‘Derivation of the Proposed Lethality

Performance Standards’’ and

‘‘Fermented Products.’’

To support the other proposed

lethality performance standards, except

for the lethality standards applicable to

commercially sterile meat and poultry

products, and to support the proposed

stabilization performance standards,

FSIS used its Nationwide

Microbiological Baseline Data

Collection Programs and Nationwide

Federal Plant Microbiological Surveys

(Ref. 3, available for viewing by the

public in the FSIS Docket Room), as

well as its technical analysis of those

surveys (Ref. 2, available for viewing by

the public in the FSIS Docket Room).

Within the technical analysis, FSIS

developed models using the baseline

and survey data to define a worst case

raw product (the highest initial levels of

Salmonella found in the data from the

microbiological surveys), and then

calculate the probability distribution for

the number of surviving Salmonella

organisms in 100 grams of finished

product for various specific lethality

reductions. Lethality performance

standards then were selected that

provided low probabilities of surviving

organisms in finished worst case

product. Most, if not all, RTE meat and

poultry products will be manufactured

from the same supply of raw product

examined in the FSIS national baseline

surveys. So, using performance

standards that would render any

hypothetical, worst case raw product

safe should be applicable to all

categories of RTE meat and poultry

products.

To support the proposed

environmental testing requirements for

Listeria spp., FSIS uses the draft

interagency risk assessment concerning

foodborne Listeria monocytogenes (Ref.

28, available for viewing by the public

in the FSIS Docket Room). As discussed

above in the section entitled ‘‘Proposed

Requirements for Controlling L.

monocytogenes,’’ this draft risk

assessment indicates that many of the

meat and poultry products affected by

these regulations (deli meat,

frankfurters, meat and poultry-based

deli salads, and paˆte ́) pose relatively

high risks to consumers because of

potential recontamination by L.

monocytogenes after lethality is applied

and before final product packaging.

XV. Additional Public Notification

Public awareness of all segments of

rulemaking and policy development is

important. FSIS provides a weekly FSIS

Constituent Update via fax to over 300

organizations and individuals. In

addition, the update is available on line

through the FSIS web page located at

http://www.fsis.usda.gov. The update is

used to provide information regarding

FSIS policies, procedures, regulations,

Federal Register notices, FSIS public

meetings, recalls, and any other types of

information that could affect or would

be of interest to our constituents/

stakeholders. The constituent fax list

consists of industry, trade, and farm

groups, consumer interest groups, allied

health professionals, scientific

professionals, and other individuals that

have requested to be included. Through

these various channels, FSIS is able to

provide information to a much broader,

more diverse audience than would be

otherwise possible. For more

information or to be added to the

constituent fax list, fax your request to

the Congressional and Public Affairs

Office, at (202) 720–5704.

XVI. Paperwork Requirements

Paperwork Requirements

In accordance with section 3507(d) of

the Paperwork Reduction Act of 1995,

the information collection or

recordkeeping requirements included in

this proposed rule have been submitted

for approval to the Office of

Management and Budget (OMB).

Abstract: FSIS has reviewed the

paperwork and recordkeeping

requirements in this proposed rule in

accordance with the Paperwork

Reduction Act. Establishments

producing RTE product would make

modifications to their HACCP plans.

Also, establishments that produce RTE

product and who do not identify L.

monocytogenes as a hazard reasonably

likely to occur, must perform tests for

Listeria spp. to verify that their

Sanitation SOPs are preventing direct

contamination or adulteration of

product. Establishments would need to

maintain these results. The proposed

revisions to the labeling requirements in

§§ 317.2 and 381.125 would effect

generically approved labels and so do

not constitute a paperwork burden.

Estimate of Burden: FSIS estimates

that 1,630 establishments will produce

paperwork and recordkeeping as a result

Federal Register / Vol. 66, No. 39 / Tuesday, February 27, 2001 / Proposed Rules 12617

of this rulemaking. Because the Agency

does not know how an establishment

will decide to implement certain

requirements of this rule, that is some

may modify their HACCP plans and

others may chose to test product, FSIS

used the total of 1,630 to make its

burden estimates for each paperwork

and recordkeeping activity. The Agency

estimates that it will take 8 hours for an

establishment to reassess their HACCP

plans for a total burden of 13,040 hours.

The Agency estimates that an

establishment will spend about 5

minutes a day (250 days) completing 1

monitoring record for each new CCP for

a total burden of 33,958 hours and 2

minutes a day filing the resulting record

for a total of 13,583 hours. FSIS assumes

each establishment will develop one

new CCP. For an establishment testing

products for Listeria spp., FSIS

estimates it will take an establishment

30 minutes a day to collect the

information and file the records for a

total of 203,750 hours.

Respondents: Meat and poultry

product establishments.

Estimated Number of Respondents:

1,630.

Estimated Number of Responses per

Respondents: 502.

Estimated Number of Responses:

818,260.

Estimated Total Annual Burden on

Respondents: 264,708.

Copies of this information collection

assessment can be obtained from Lee

Puricelli, Paperwork Specialist, Food

Safety and Inspection Service, USDA,

Room 109 Cotton Annex, Washington,

DC 20250–3700.

Comments are invited on: (a) Whether

the proposed collection of information

is necessary for the proper performance

of the functions of the Agency,

including whether the information will

have practical utility; (b) the accuracy of

the Agency’s estimate of the burden of

the proposed collection of information

including the validity of the method and

the assumptions used; (c) ways to

enhance the quality, utility, and clarity

of the information to be collected; (d)

ways to minimize the burden of the

collection of information on those who

are to respond; including through use of

appropriate automated, electronic,

mechanical, or other technological

collection techniques or other forms of

information technology. Comments may

be sent to Lee Puricelli, see the address

above, and to the Desk Officer for

Agriculture, Office of Information and

Regulatory Affairs, Office of

Management and Budget (OMB)

Washington, DC 20253. A comment to

OMB is best assured of having its full

effect if OMB receives is within 30 days

of publication of this proposed rule.

XVII. References

The following sources are referred to

in this document. All have been placed

on display in the FSIS Docket Room

(address above) and may be seen by

interested persons between 8:30 a.m.

and 4:30 p.m., Monday through Friday.

1. FSIS Office of Public Health and Science,

‘‘Draft Risk Assessment of the Public

Health Impact of Escherichia coli O157:H7

in Ground Beef, 2000.

2. Ahmed, N. M., D. E. Conner, and D.L.

Huffman, ‘‘Heat-resistance of Escherichia

coli O157:H7 in meat and poultry as

affected by product composition,’’ Journal

of Food Science, 60(3): 606–610, 1995.

3. FSIS, ‘‘Lethality and Stabilization

Performance Standards for Certain Meat

and Poultry Products: Technical Paper,’’

1998.

4. FSIS, Microbiological Baseline Data

Collection Program reports and

Microbiological Surveys, 1994–1996.

5. American Gastroenterological Association,

‘‘Consensus Conference Statement:

Escherichia coli O157:H7 Infections-An

Emerging National Health Crisis, July 11–

13, 1994,’’ Gastroenterology, 108(6):1923–

1934, 1995.

6. Wells, J. G., et al., ‘‘Laboratory

Investigation of Hemorrhagic Colitis

Outbreaks Associated with a Rare

Escherichia coli Serotype,’’ Journal of

Clinical Microbiology, 18:512–520, 1983.

7. Todd, E.C.D., et al., ‘‘Rapid Hydrophobic

Grid Membrane Filter-Enzyme-Labeled

Antibody Procedure for Identification and

Enumeration of Escherichia coli O157 in

Foods,’’ Applied Environmental

Microbiology, 54:2536–2540, 1988.

8. Harrison, J.A. and M. A. Harrison, ‘‘Fate

of Escherichia coli O157:H7, Listeria

monocytogenes, and Salmonella

typhimurium during preparation and

storage of beef jerky,’’ Journal of Food

Protection, 59:1336–1338, 1996.

9. Harrison, J. A., M. A. Harrison, and R.A.

Rose, ‘‘Fate of Listeria monocytogenes and

Salmonella species in ground beef jerky,’’

Journal of Food Protection, 60:9:1139–

1141, 1997.

10. Harrison, J. A., M. A. Harrison, and R.A.

Rose, ‘‘Survival of Escherichia coli

O157:H7 in ground beef jerky assessed on

two plating media Journal of Food

Protection,’’ 61:11:13., 1998.

11. CDC, Morbidity and Mortality Weekly

Report, 44:785–788, 1995.

12. Keene, W.E., et al., ‘‘An outbreak of

Escherichia coli O157:H7 infections traced

to jerky made from deer meat,’’ Journal of

the American Medical Association,

277:15:1229–1231, 1997. 

13. Tompkin, R. B., ‘‘Microbiology of readyto-eat meat and poultry products,’’ pp. 89–

121, in Advances in Meat Research,

volume 2, A. M. Pearson and T.R. Dutson,

eds., AVI Publishing Co., Westport, CT.,

1986.

14. Gonzalez-Helva, M.A., M.F. Gutierrez,

and M.C. Mendoza, ‘‘Diagnosis by a

combination of typing methods of a

Salmonella typhimurium outbreak

associated with cured ham,’’ Journal of

Food Protection, 59:426–428, 1996.

15. Mete, R., R. R. Fichera, and P. Chierchini,

‘‘Episodio di tossinfezione alimentare da

Salmonella C2 trasmessa da prosciutto,’’

Nuovi Annali d’Igiene e Microbiologia,

38:219–224, 1987.

16. CDC, Morbidity and Mortality Weekly

Report, 44(9):157–160, 1995.

17. FSIS Epidemiology and Emergency

Response Program, ‘‘Outbreak Report:

Salmonella in Lebanon Bologna,’’ May 22,

1996.

18. Haymon, L.W., ‘‘Fermented sausage,’’ pp.

237–245, in Industrial Microbiology, 4th

Edition, Prescott and Dunn, eds., AVI

Publishing Co., Westport, CT., 1982.

19. Tatini, S. R., ‘‘Influence of food

environments on growth of Staphylococcus

aureus and production of enterotoxins,’’

Journal of Milk Food Technology,

36(11):559–563, 1973.

20. Smith, J.L., et al., ‘‘Survival of Salmonella

dublin and Salmonella typhimurium in

Lebanon bologna,’’ Journal of Milk Food

Technology, 38(3):150–154, 1975.

21. Bacus, J., ‘‘Processing procedures to

control Salmonella and E. coli in

fermented sausage products,’’ Food

Australia, 49(11):543–7, 1997.

22. Ellajosyula, K.R., et al., ‘‘Destruction of E.

coli O157:H7 and Salmonella typhimurium

in Lebanon bologna by interaction of

fermentation pH, heating temperature and

time,’’ Journal of Food Protection,

61(2):152–157, 1998.

23. Faith, N.G., et al., ‘‘Viability of

Escherichia coli O157:H7 in pepperoni

during the manufacture of sticks and the

subsequent storage of slices at 21, 4 and

¥20C under air vacuum and CO2,’’

International Journal of Food Microbiology,

37:47–54, 1997.

24. Glass, K.A., et al., Applied Environmental

Microbiology, Fate of Esherichia coli

O157:H7 as affected by pH or sodium

chloride and in fermented, dry sausage,

58(8):2513–2516, 1992.

25. Labbe, R., ‘‘Clostridium perfringens,’’ pp.

210 and 213, in Food borne Bacterial

Pathogens, M. Doyle (ed.), Marcel Dekker,

Inc., New York, 1989.

26. Hauschild, A., ‘‘Criteria and Procedures

for Implicating Clostridium Perfringens in

Food-borne Outbreaks,’’ Canadian Journal

of Public Health, 66:388–392, 1975.

27. McClane, B.A., ‘‘Clostridium Perfringens

Enterotoxin: Structure, Action, and

Detection,’’ Journal of Food Safety, 12:237–

252, (1992).

28. Center for Food Safety and Applied

Nutrition, FDA, and FSIS, ‘‘Draft Risk

Assessment of the Public Health Impact of

Foodborne Listeria monocytogenes,’’

January 19, 2001.

29. Tompkin, R. Bruce, et al., ‘‘Guidelines to

Prevent Post-Processing Contamination

from Listeria Monocytogenes,’’ Dairy, Food,

and Environmental Sanitation, 8:552,

1999.

30. Pflug, I.J., T.E. Odlaug, ‘‘A review of z

and F values used to ensure the safety of

low-acid canned food,’’ Food Technology,

32:63–70, 1978.

31. Pflug, I.J., ‘‘Calculating FT values for heat

preservation of shelf-stable, low-acid

12618 Federal Register / Vol. 66, No. 39 / Tuesday, February 27, 2001 / Proposed Rules

canned foods using the straight-line

semilogarithmic model,’’ Journal of Food

Protection, 50:608–620, 1987.

32. Beumer, R. R., Mc C. te Giffel, E. de Boer,

and F. M. Rombouts. 1996. Growth of

Listeria monocytogenes on sliced cooked

meat products. Food Microbiology 13: 333–

340.

33. Centers for Disease Control and

Prevention. 1999. Update: Multi-state

outbreak of listeriosis—United States,

1998–1999. Morbidity and Mortality

Weekly Report 47(50): 1117–1118.

34. Anderson, G., Contra Costa County

Health Department, San Francisco

Department of Public Health, L. Mascola,

G. W. Rutherford, M. S. Rados, R.

Hutchenson, P. Archer, P. Zenker, C.

Harvey, J. D. Smith, and CDC. 1992.

Update: Foodborne listeriosis—United

States, 1988–90, pages 251, 257–258,

Morbidity and Mortality Weekly Report.

35. Office of Inspector General, USDA. June

2000. FSIS Implementation of HACCP,

Report No. 24001–3–At.

XVIII. Proposed Regulations

List of Subjects

9 CFR Part 301

Meat inspection.

9 CFR Part 303

Meat inspection, Reporting and

recordkeeping requirements.

9 CFR Part 317

Food labeling.

9 CFR Part 318

Meat inspection, Reporting and

recordkeeping requirements.

9 CFR Part 319

Food grades and standards, Food

labeling, Frozen foods, Meat inspection,

Oils and fats.

9 CFR Part 320

Meat inspection, Reporting and

recordkeeping requirements.

9 CFR Part 325

Meat inspection, Reporting and

recordkeeping requirements,

Transportation.

9 CFR Part 331

Intergovernmental regulations, Meat

inspection.

9 CFR Part 381

Poultry and poultry products

inspection, Reporting and

recordkeeping requirements.

9 CFR Part 417

Meat inspection, Poultry and poultry

products inspection, Reporting and

recordkeeping requirements.

9 CFR Part 430

Food labeling, Meat inspection,

Poultry and poultry products

inspection.

Accordingly, title 9, chapter III, of the

Code of Federal Regulations is amended

as follows:

PART 301—DEFINITIONS

1. The authority citation for part 301

would continue to read as follows:

Authority: 7 U.S.C. 450, 1901–1906; 21

U.S.C. 601–695; 7 CFR 2.18, 2.53.

2. Section 301.2 would be amended

by removing the definitions for ‘‘Process

authority’’ and ‘‘Process schedule.’’

PART 303—EXEMPTIONS

3. The authority citation for part 303

would continue to read as follows:

Authority: 21 U.S.C. 601–695; 7 CFR 2.17,

2.55.

4. In § 303.1(f), the second sentence

would be removed.

PART 317—LABELING, MARKING

DEVICES, AND CONTAINERS

5. The authority citation for part 317

would continue to read as follows:

Authority: 21 U.S.C. 601–695; 7 CFR 2.18,

2.53.

6. In § 317.2, paragraph (k) and the

introductory text of paragraph (l) would

be revised to read as follows:

§ 317.2 Labels: definition; required

features.

* * * * *

(k) Packaged products which require

special handling to maintain their

wholesome condition must have

prominently displayed on the principal

display panel the statement: ‘‘Keep

Refrigerated,’’ ‘‘Keep Frozen,’’

‘‘Perishable Keep Under Refrigeration,’’

or ‘‘Refrigerate after Opening,’’ as

applicable, or such similar statement as

the Administrator may approve in

specific cases. Products that are

distributed frozen during distribution

shall bear the statement on the shipping

container: ‘‘Keep Frozen.’’ The

consumer-size containers for such

products that are thawed prior to or

during display for sale at retail shall

bear the statement ‘‘Previously Handled

Frozen for Your Protection, Refreeze or

Keep Refrigerated.’’ For all perishable

canned products the statement shall be

shown in upper case letters one-fourth

inch in height for containers having a

net weight of 3 pounds or less, and for

containers having a net weight over 3

pounds, the statement shall be in upper

case letters at least one-half inch in

height.

(l) Safe handling instructions shall be

provided for: All meat and meat

products of cattle, swine, sheep, goat,

horse, or other equine that do not meet

the requirements contained in 9 CFR

430.2 and 430.3(a), except as exempted

under paragraph (l)(4) of this section.

* * * * *

PART 318—ENTRY INTO OFFICIAL

ESTABLISHMENTS; REINSPECTION

AND PREPARATION OF PRODUCT

7. The authority citation for part 318

would continue to read as follows:

Authority: 7 U.S.C. 138f, 7 U.S.C. 450,

1901–1906; 21 U.S.C. 601–695; 7 CFR 2.18,

2.53.

8. Section 318.10 would be removed

and reserved.

9. Section 318.17 would be removed

and reserved.

10. Section 318.23 would be removed

and reserved.

11. Subpart G (§§ 318.300 through

318.311) would be removed.

PART 319—DEFINITIONS AND

STANDARDS OF IDENTITY OR

COMPOSITION

12. The authority citation for part 319

would continue to read as follows:

Authority: 7 U.S.C. 450, 1901–1906; 21

U.S.C. 601–695; 7 CFR 2.17, 2.55.

13. In § 319.106, paragraph (b) would

be removed; paragraph (c) would be

redesignated as paragraph (b); and

paragraph (d) would be redesignated as

paragraph (c).

14. In § 319.145, paragraph (a)(2)

would be amended by removing the

third sentence.

PART 320—RECORDS,

REGISTRATION, AND REPORTS

15. The authority citation for part 320

would continue to read as follows:

Authority: 21 U.S.C. 601–695; 7 CFR 2.18,

2.53.

16. In § 320.1, paragraph (b)(6) and

(b)(7) would be removed; paragraph

(b)(8) would be redesignated as (b)(6);

paragraph (b)(9) would be redesignated

as (b)(7); paragraph (b)(10) would be

redesignated as (b)(8); and paragraph

(b)(11) would be redesignated as (b)(9).

PART 325—TRANSPORTATION

17. The authority citation for part 325

would continue to read as follows:

Authority: 7 U.S.C. 450, 1901–1906; 21

U.S.C. 601–695; 7 CFR 2.17, 2.55.

18. In § 325.7, paragraph (a) would be

amended by removing the phrase, ‘‘pork

that has been refrigerated to destroy

trichina,’’.

Federal Register / Vol. 66, No. 39 / Tuesday, February 27, 2001 / Proposed Rules 12619

PART 331—SPECIAL PROVISIONS

FOR DESIGNATED STATES AND

TERRITORIES; AND FOR

DESIGNATION OF ESTABLISHMENTS

WHICH ENDANGER PUBLIC HEALTH

AND FOR SUCH DESIGNATED

ESTABLISHMENTS

19. The authority citation for part 331

would continue to read as follows:

Authority: 21 U.S.C. 601–695; 7 CFR 2.17,

2.55.

20. In § 331.5, paragraph (a)(1)(ii)

would be amended to remove the

phrase, ‘‘or it is a ready-to-eat pork

product which has not been treated to

destroy trichinae as prescribed in

§ 318.10 of this subchapter for products

at federally inspected establishments);

or’’.

PART 381—POULTRY PRODUCTS

INSPECTION REGULATIONS

21. The authority citation for part 381

would continue to read as follows:

Authority: 7 U.S.C. 138f, 450; 21 U.S.C.

451–470; 7 CFR 2.18, 2.53.

22. Section 381.1 would be amended

by removing the definitions for ‘‘Process

authority’’ and ‘‘Process schedule.’’

23. In § 381.125, paragraph (a) would

be revised to read as follows:

§ 381.125 Special handling label

requirements.

(a) Packaged products which require

special handling to maintain their

wholesome condition must have

prominently displayed on the principal

display panel the statement: ‘‘Keep

Refrigerated,’’ ‘‘Keep Frozen,’’

‘‘Perishable Keep Under Refrigeration,’’

or ‘‘Refrigerate after Opening,’’ as

applicable, or such similar statement as

the Administrator may approve in

specific cases. Products that are

distributed frozen during distribution

shall bear the statement on the shipping

container: ‘‘Keep Frozen.’’ The

consumer-size containers for such

products that are thawed prior to or

during display for sale at retail shall

bear the statement ‘‘Previously Handled

Frozen for Your Protection, Refreeze or

Keep Refrigerated.’’ For all perishable

canned products the statement shall be

shown in upper case letters one-fourth

inch in height for containers having a

net weight of 3 pounds or less, and for

containers having a net weight over 3

pounds, the statement shall be in upper

case letters at least one-half inch in

height.

* * * * *

24.–25. In § 381.125, the introductory

text of paragraph (b) would be amended

by removing the phrase ‘‘§ 381.150(a) or

that have not undergone other

processing that would render them

ready-to-eat’’ and by adding the phrase

‘‘9 CFR 430.2 and 430.3(a)’’ in its place.

26. Section 381.150 would be

removed.

27. In § 381.175, paragraph (b)(3)

would be removed; paragraph (b)(4)

would be redesignated as (b)(3);

paragraph (b)(5) would be redesignated

as (b)(4); and paragraph (b)(6) would be

redesignated as (b)(5).

28. Subpart X (§§ 381.300 through

381.311) would be removed and

reserved.

PART 417—HAZARD ANALYSIS AND

CRITICAL CONTROL POINT (HACCP)

SYSTEMS

29. The authority citation for Part 417

would continue to read as follows:

Authority: 7 U.S.C. 450; 21 U.S.C. 451–

470, 601–695; 7 U.S.C. 1901–1906; 7 CFR

2.18, 2.53.

§ 417.2 Hazard Analysis and HACCP plan.

30. Paragraph 417.2(b)(3) would be

removed.

PART 430—PERFORMANCE

STANDARDS

31. A new Part 430 would be

established to read as follows:

PART 430—PERFORMANCE

STANDARDS FOR READY-TO-EAT

AND PARTIALLY HEAT-TREATED

PRODUCTS

Sec.

430.1 Definitions.

430.2 Lethality.

430.3 Stabilization.

430.4 Testing for Listeria spp.

430.5 Thermally-processed, commercially

sterile products.

Authority: 7 U.S.C. 450; 21 U.S.C. 451–

470, 601–695; 7 U.S.C. 1901–1906; 7 CFR

2.18, 2.53.

§ 430.1 Definitions.

Acidified product. A commercially

sterile and hermetically sealed product

that has been formulated or treated so

that every component has a pH value of

4.6 or lower within 24 hours after

completion of the thermal process

unless a longer time has been validated

as safe.

Commercial sterility. The condition

achieved by the application of a heat,

irradiation, high-pressure, or other

process, alone or in combination with

other ingredients or treatments, to

render the product free of

microorganisms capable of growing in

the product at nonrefrigerated

conditions (over 50 °F or 10 °C) at

which the product is intended to be

held during distribution and storage.

Fermented product. A meat or poultry

product that is made ready-to-eat by the

process in which bacterial enzymes act

on organic substrates, such as

carbohydrates, resulting in the

production of acid (the lowering of

product pH) and microbial inhibition.

Low acid product. A commercially

sterile and hermetically sealed product

in which any component has a pH value

above 4.6.

Ready-to-eat product. A meat or

poultry product that can be safely

consumed without cooking or

application of some other lethality

treatment to destroy pathogens.

Worst case product. For purposes of

the lethality requirements contained in

§ 430.2(a)(1), worst case raw poultry

contains 6.7-log10 of Salmonella in any

143 gram sample and worst case raw

meat contains 6.2-log10 of Salmonella in

any 143 gram sample; for purposes of

the lethality requirements contained in

§ 430.2(b)(1), worst case raw beef

contains 4.4-log10 of E. coli O157:H7 in

any 143 gram sample.

§ 430.2 Lethality.

(a) (1) Processing of any meat or

poultry product, except a thermallyprocessed, commercially sterile product,

for the purpose of rendering that

product ready-to-eat, must be validated

to achieve probabilities no greater than

the following that Salmonella organisms

would remain in any 100 gram sample

of finished product, assuming that

incoming raw product is worse case

product. Any detectable level of viable

Salmonella organisms adulterates readyto-eat meat and poultry products.

>0 surviving >1 surviving >2 surviving >3 surviving >4 surviving

39.4% 9.06% 1.45% 0.177% 0.0174%

(2) Official establishments that do not

wish to demonstrate that their

processing results in probabilities no

greater than the probabilities in

paragraph (a)(1) of this section may

instead employ processing validated to

12620 Federal Register / Vol. 66, No. 39 / Tuesday, February 27, 2001 / Proposed Rules

achieve either a 6.5-log10 reduction of

Salmonella throughout a finished,

ready-to-eat meat product, or, a 7-log10

reduction of Salmonella throughout a

finished ready-to-eat product that

contains any amount of poultry. Any

detectable level of viable Salmonella

organisms adulterates ready-to-eat meat

and poultry products.

(b)(1) In addition to meeting the

standard in paragraph (a), of this section

processing of any fermented meat or

poultry product that contains any

amount of beef, except a thermallyprocessed, commercially sterile product,

for the purpose of rendering that

product ready-to-eat, must be validated

to achieve probabilities no greater than

the following that E. coli O157:H7

organisms would remain in any 100

gram sample of finished product,

assuming that incoming raw product is

worst case product. Any detectable level

of viable E. coli O157:H7 organisms

adulterates ready-to-eat meat and

poultry products.

>0 surviving >1 surviving

22.2% 2.67%

(2) Official establishments that do not

wish to demonstrate that their

processing results in probabilities no

greater than the probabilities in

paragraph (b)(1) of this section may

instead employ processing validated to

achieve a 5-log10 reduction of E. coli

O157:H7 throughout a finished, readyto-eat meat or poultry product that

contains any amount of beef. Any

detectable level of viable E. coli

O157:H7 organisms adulterates readyto-eat meat and poultry products.

(c) Processing of all ready-to-eat meat

and poultry products, other than

thermally processed, commercially

sterile products, also must be validated

to achieve the reduction of other

pathogens and their toxins or toxic

metabolites necessary to prevent

product adulteration.

(d) Processing of all ready-to-eat

products, other than thermally

processed, commercially sterile

products, must be validated to maintain

the lethality performance standards

throughout product shelf-life under the

conditions in which the food is stored,

distributed, and held.

§ 430.3 Stabilization.

(a) For all ready-to-eat meat and

poultry products, other than thermally

processed, commercially sterile

products, processing must prevent

multiplication of toxigenic

microorganisms such as Clostridium

botulinum and allow no more than 1-

log10 multiplication of Clostridium

perfringens within the product.

(b) For all meat and poultry products

that receive a heat treatment but that are

not ready-to-eat, processing must

prevent multiplication of toxigenic

microorganisms such as C. botulinum

and allow no more than 1-log10

multiplication of C. perfringens within

the product.

(c) Processing of all ready-to-eat

products, other than thermally

processed, commercially sterile

products, and products that are heattreated but not ready-to-eat, must be

validated to maintain the stabilization

performance standards throughout

product shelf-life under the conditions

in which the food is stored, distributed,

and held.

§ 430.4 Testing for Listeria spp.

(a) Each official establishment that

produces one or more ready-to-eat meat

or poultry products, but that has not

identified Listeria monocytogenes as a

hazard reasonably likely to occur within

the HACCP plan for its ready-to-eat

product and consequently established

one or more controls for L.

monocytogenes to be implemented after

lethality treatment is complete, must

test food contact surfaces, on which

product is handled after lethality

treatment but before final packaging, for

Listeria spp. at one of the following

frequencies depending on establishment

size:

(1) If the plant is large (500 or more

employees), at least four tests, per line

of ready-to-eat product, per month;

(2) If the plant is small (10 to 499

employees), at least two tests, per line

of ready-to-eat product, per month;

(3) If the plant is very small (fewer

than 10 employees or annual sales of

ready-to-eat products less than $2.5

million), at least one test, per line of

ready-to-eat product, per month.

(b) Results of the testing required in

this section are to be used by official

establishments to verify that their

Sanitation Standard Operating

Procedures (Sanitation SOPs), as

required under 9 CFR part 416, are

preventing direct contamination or

adulteration of product. Results must be

made available to FSIS personnel for

review. In the event of a positive test

result, establishments must take

corrective actions under 9 CFR 416.15(a)

and (b) that include the following

procedures to determine and

demonstrate that the affected lot or lots

of product are not adulterated with L.

monocytogenes:

(1) Procedures to determine which lot

or lots of product might have been

affected;

(2) Procedures to hold, sample, and

test that product for L. monocytogenes;

and

(3) Procedures to dispose of affected

product.

§ 430.5 Thermally processed,

commercially sterile products.

(a) For a low-acid product that

receives thermal or other sporicidal

lethality processing, that processing

must be validated to achieve a

probability of 10¥9 that there are spores

of C. botulinum in a container of the

product that are capable of growing, or,

a 12-log10 reduction of C. botulinum,

assuming an initial load of ≤ 1000

spores per container.

(b) For acidified products or products

in which pathogen growth is controlled

by factors other than thermal or other

sporicidal processing, the processing

must be validated to prevent

multiplication of C. botulinum in the

food under the conditions in which the

food is stored, distributed, and held.

(c) The product must be processed to

achieve commercial sterility and the

container in which the product is

enclosed must be hermetically sealed so

as to be airtight and to protect the

contents of the container against the

entry of microorganisms during and

after processing.

(d) All operators of processing

systems for commercially sterile meat

and poultry products and container

closure technicians shall be under the

direct supervision of a person who has

successfully completed a school of

instruction that is generally recognized

as adequate for training supervisors of

canning operations.

Done in Washington, DC on February 16,

2001.

Thomas J. Billy,

Administrator.

The following is an appendix to the

preamble of the Proposed Rule.

Note: The following appendix will not

appear in the Code of Federal Regulations.

Appendix 1

Executive Order 12866—Preliminary

Analysis

This proposed action has been reviewed

for compliance with Executive Order 12866.

Because this proposed action has been

determined to be economically significant for

purposes of Executive Order 12866, the

Office of Management and Budget has

reviewed it.

Proposed Action

FSIS is proposing to amend the Federal

meat and poultry inspection regulations by

establishing pathogen reduction performance

standards for all ready-to-eat (RTE) and all

partially heat-treated meat and poultry

Federal Register / Vol. 66, No. 39 / Tuesday, February 27, 2001 / Proposed Rules 12621

1Center for Food Safety and Applied Nutrition,

FDA, and FSIS, ‘‘Draft Risk Assessment of the

Public Health Impact of Foodborne Listeria

monocytogenes,’’ January 19, 2001.

2Samualson and Nordhaus, Economics, 16th

Edition, McGraw Hill Publishers, 1998.

products. FSIS also is proposing to require

establishments that produce RTE meat and

poultry products to conduct food contact

surface testing for Listeria spp. to verify that

they are controlling Listeria monocytogenes

within their processing environments.

Establishments that have developed and

implemented HACCP controls for L.

monocytogenes would be exempt from these

testing requirements. Finally, FSIS is

proposing to eliminate its regulations that

require that both RTE and not-ready-to eat

pork and products containing pork be treated

to destroy trichina; these requirements are

inconsistent with HACCP and some will be

unnecessary if FSIS makes final the proposed

performance standards for RTE meat and

poultry products.

Need for the Rule

This proposed action is compelled by

recent outbreaks of foodborne illness related

to the consumption of adulterated RTE meat

and poultry products, as well as by the need

to provide objective, measurable pathogen

reduction standards that can be met by

official establishments and compliance with

which can be established through Agency

inspection. Although FSIS routinely samples

and tests some RTE products for the presence

of pathogens prior to distribution, there are

no specific regulatory pathogen reduction

requirements for most of these products (e.g.,

there are no existing lethality requirements

for products such as hotdogs similar to the

lethality performance standards for roast

beef). Except for cooked meat patties (which

currently have prescriptive time and

temperature requirements for lethality), roast

beef products (which have the new lethality

performance standards), cooked poultry

(which have the new lethality performance

standards), and canned meat and poultry

(which have the current prescriptive process

requirements), the remaining RTE meat and

poultry products do not have regulationspecified criteria for establishing safe

processes other than the products must not

be adulterated. Therefore, to ensure the safety

of these products, FSIS is proposing

performance standards for RTE and partially

heat-treated meat and poultry products.

The Sanitation Standard Operating

Procedures (SOPs) and HACCP regulations

were intentionally written to allow the

regulated industry flexibility in the design of

their procedures. FSIS is adding, through this

proposed rule, minimum criteria to be

addressed to prevent post-lethality

contamination. In the Sanitation SOPs, the

proposed requirements will ensure that

establishments maintain minimal specific

records and take specific action. If the

establishment determines that a hazard is

reasonable likely to occur, then the HACCP

regulations will be addressed via CCPs and

related performance standards, controls, and

records.

Performance standards are an integral part

of the HACCP systems in official meat and

poultry establishments. HACCP provides the

framework for industry to set up sciencebased process controls. Performance

standards tell establishments what those

controls need to achieve for their HACCP

plans to be effective and provide a necessary

measure of accountability for achieving

acceptable food safety. The proposed

performance standards will provide meat and

poultry establishments with the incentive

and flexibility to adopt innovative, sciencebased processing procedures and controls;

ensure safety for consumers; and provide

objective, measurable standards, compliance

with which can be determined through

Agency inspection. Therefore, FSIS believes

that developing HACCP systems around

verifiable, objective performance standards is

the most effective way for establishments to

consistently produce safe, unadulterated

meat and poultry products. Furthermore, by

proposing performance standards for

pathogens whose destruction results in the

destruction of most or all other pathogens of

concern, FSIS provides a reference for

establishments to use in gauging the efficacy

of their HACCP systems.

The proposed food-contact surface testing

requirements are compelled by the recent L.

monocytogenes outbreak attributed to

contaminated hotdogs and the recent

interagency draft risk assessment 1

concerning L. monocytogenes, which shows

that there is significant opportunity for

recontamination of RTE meat and poultry

products during processing in the plant, after

the lethality is applied. These data indicate

that many establishments that produce RTE

meat and poultry products are not effectively

implementing Sanitation SOPs so as to

prevent direct contamination of RTE meat

and poultry products by L. monocytogenes.

Therefore, FSIS is proposing to require that

all establishments that produce RTE meat

and poultry products conduct environmental

testing of food-contact surfaces for Listeria

spp., after lethality treatment and before final

product packaging, unless they have

identified L. monocytogenes as a hazard

reasonably likely to occur and so have

incorporated into their HACCP systems one

or more controls validated to eliminate it

from their products. This testing will verify

that an establishment’s Sanitation SOPs are

preventing direct product contamination by

L. monocytogenes after the lethality

treatment, thus addressing the draft risk

assessment assertion and other research

findings that RTE foods often are

recontaminated by L. monocytogenes after

lethality is applied.

In regard to thermally processed,

commercially sterile (most often canned)

meat and poultry products, the proposed

standards represent regulatory reform; they

replace lengthy, prescriptive regulations with

performance standards that provide the same

level of food safety, as well as increased

flexibility for establishments to customize

their processes under HACCP. Market

Failure. Market failure occurs here because

consumers cannot identify (and reward)

those firms that both supply RTE products

and implement the desired food safety

safeguards and consequently shift

consumption away from suppliers of

products that may present a threat to public

health. These lower cost firms may not apply

the most effective pathogen prevention

methods and could be supplying a product

that could lead to illness or death. Two main

problems exist in many cases: lack of

definitive cause and effect between

consumption of the product in question and

the illness or death (information gathering of

epidemiological evidence) and difficulty in

identifying the source of the original

contamination (technical trace-back

capabilities). Clearly, no individual

consumer who may be stricken with a

foodborne illness would have the means to

overcome these two problems. The proposed

rule tries to remedy this market failure. This

is particularly true at this time with respect

to L. monocytogenes.

Baseline

The most recent year in which both

listeriosis cases and economic background

information on the affected industries are

available is 1997. The baseline analysis

assumes that if no regulatory-induced

producer actions took place, these baseline

values would persist annually over a 10-year

period. The analysis then proceeds by

introducing only those changes that are

projected to occur as a result of provisions of

the proposed rule. Once these provisions

come into effect, benefits accrue in the form

of gradually reduced annual numbers of

listeriosis cases and deaths, while costs are

registered in the form of higher compliance

and operating costs. This ceteris paribus

assumption (all else held constant while

allowing for a change in one variable at a

time) and use of a static baseline avoids the

thorny issue of forecasting the nature and

magnitude of non-regulatory induced

industry and food safety changes over this

period not related to changes in regulatory

requirements. Both the ceteris paribus

assumption and the static baseline are

standard analytical techniques used in

economic analysis.2 Section A discusses the

nature of the industries likely affected by the

proposed rule (numbers and size of

establishments and type of products

produced). This discussion is followed by a

discussion of the current regulatory

environment that these establishments

operate within. Section C presents the

baseline level of listeriosis cases and deaths

which anchors the expected benefits of the

proposed rule.

A. The Nature of the Industries Affected and

Current Industry Practices

The 1997 Census of Manufacturers

identifies 1630 establishments that could be

affected by the proposed rule. For this

analysis, these establishments are broken

down into four broad groups differentiated

by the estimated costs of compliance with all

of the proposed provisions. The groups that

would incur the greatest costs include

establishments that may have to revise their

HACCP plans and Sanitation SOPs in order

to comply with both the proposed

performance standards and testing

requirements. The number of establishments,

12622 Federal Register / Vol. 66, No. 39 / Tuesday, February 27, 2001 / Proposed Rules

3These data were extrapolated from the 1997

Census of Manufacturers. The actual data reported

over $30 billion in shipments, involving 1320

establishments, but did not account for several

important factors: specific volumes of product

shipments with meat and poultry, i.e., pizza, dinner

entries, canned product shipments with meat and/

or poultry; scant information on size distribution;

and many missing values for important product

classes. In general, about 80 percent of these

establishments produce mostly cooked and

otherwise processed meat and poultry products; the

other 20 percent produce fermented, acidified,

dried, salted cured, and canned meat and poultry

products.

the types of products shipped, and value of

shipments of these groups are summarized

below (Table 1). The total value of shipments

of all of the products in 1997 totaled around

$28 billion.3

These groups are further broken down into

sub-groups where appropriate.

The main product groups (and sub-groups,

if appropriate) are:

Group I, those entities that likely will incur

the greatest costs and which are further

broken down into:

Sub-group 1, RTE fermented, dried, and

salt cured meat and poultry products;

Sub-group 2, RTE hotdogs and wieners;

Sub-group 3, RTE frozen meat and poultry

patties; and,

Sub-group 4, RTE smoked hams and

poultry luncheon meats;

Group II, those entities that likely will

incur moderate costs and which are further

broken down into:

Sub-group 1, meat processing

establishments that make RTE boiled hams,

other sausages, and other frozen or cooked

meats, such as barbecue pork;

Sub-group 2, poultry processors that make

RTE jellied goods and other processed

poultry products, including paˆte ́ and spreads;

and

Sub-group 3, combo plants who produce

both RTE meat and poultry;

Group III, those entities that likely will

incur minor costs; representative products

include RTE frozen dinners, pizzas, and

other frozen meat and poultry products; and

Group IV, those entities likely will incur

no costs; representative products include

RTE canned meat and poultry products.

TABLE 1.—NUMBER, TYPE OF MEAT AND POULTRY PRODUCTS (MPP’S) SHIPPED, AND VALUE OF PRODUCT SHIPMENTS

BY ESTABLISHMENT GROUPING, 1997

Group—

subgroup

Number of

MPP’s

(% of total)

Value of shipments in

millions

(% of total)

Combo plants

that slaughter

and process

meat

(% of total)

Processors

(% of total)

Examples of MPP’s shipped

Meat * Poultry Others **

I–All ............ 584

(36%)

10537

(37%)

77

(5%)

421

(26%)

86

(5%)

0 Fermented, acidified, dried, saltcured products, hotdogs, meat

patties, and luncheon meats.

I–1 .............. 150

(9%)

1590

(6%)

28

(2%)

122

(7%)

0 0 [Fermented] dry or summer sausage, salami, cured smoked

sticks, Lebanon bologna,

pepperoni, chorizo, poultry

mortadella, chicken/turkey salami; [Dried] beef jerky, dried

beef or pork sticks, dried beef

slices, carne seca, basturma,

soujouk, manneh dry duck

breast, poultry jerky; [Salt cured]

country cured ham, coppa,

cappicola, prosciutto, pancetta,

dry cured duck; [others] pickled

pigs feet, pickled meat/sausages, chorizo with added vinegar, Hickory farm beef sticks.

I–2 .............. 167

(10%)

2365

(8%)

18

(1%)

112

(7%)

37

(2%)

0 Frankfurters and wieners, turkey

and chicken franks.

I–3 .............. 76

(5%)

528

(2%)

0 76

(5%)

0 0 Sausage or meat and poultry patties, fully cooked, uncured meat

patties.

I–4 .............. 191

(12%)

6054

(21%)

31

(2%)

111

(7%)

49

(3%)

0 Pastrami, bologna, roast beef,

bratwurst, bockwurst, poultry

and meat roll products.

II–All ........... 791

(49%)

12539

(44%)

76

(5%)

551

(34%)

164

(10%)

0 Otherwise processed meat and

poultry products.

II–1 ............. 551

(34%)

4883

(17%)

0 551

(34%)

0 0 Beef burritos, corned beef, chili,

frozen entrees and meat soups,

breakfast link, meatballs, ravioli,

pork and beans, some poultry

rolls, other cooked poultry, paˆte ́,

meat and poultry spreads, turkey

BBQ, uncured meat products,

i.e. beef stew.

II–2 ............. 164

(10%)

6696

(24%)

0 0 164

(10%)

0

II–3 ............. 76

(5%)

960

(3%)

76

(5%)

0 0 0 D.

III ................ 104

(6%)

2979

(11%)

0 0 0 104

(6%)

Frozen pizza with meat toppings;

frozen entries.

Federal Register / Vol. 66, No. 39 / Tuesday, February 27, 2001 / Proposed Rules 12623

4The industry survey was sponsored by: National

Food Processors Association (NFPA), American

Meat Institute (AMI), National Turkey Federation

(NTA), National Chicken Council (NCC), National

Meat Association (NMA), North American Meat

Processors (NAMP), Southwest Meat Association

(SMA), and American Association of Meat

Processors (AAMP).

TABLE 1.—NUMBER, TYPE OF MEAT AND POULTRY PRODUCTS (MPP’S) SHIPPED, AND VALUE OF PRODUCT SHIPMENTS

BY ESTABLISHMENT GROUPING, 1997—Continued

Group—

subgroup

Number of

MPP’s

(% of total)

Value of shipments in

millions

(% of total)

Combo plants

that slaughter

and process

meat

(% of total)

Processors

(% of total)

Examples of MPP’s shipped

Meat * Poultry Others **

IV ............... 151

(9%)

2165

(8%)

0 26

(2%)

4

(-%)

121

(7%)

Canned products such as canned

Poultry spreads and spaghetti

sauce.

Total ... 1630 28220.0 153

(9%)

998

(61%)

254

(16%)

225

(14%)

All of the Above.

* These processors make product from received meat carcasses and/or slaughter and process.

** Others include canners, frozen food makers, and other prepared food manufacturers.

Group I

Within Group I, 150 establishments

produce fermented, dried, and salt cured

meat and poultry products (Sub-group 1).

These establishments make up nine percent

of the total number of establishments

potentially affected by this proposed rule and

ship out about six percent of the total value

of shipments. Over eighty percent of these

establishments are processors, over 95

percent of who employ fewer than 500

employees.

The second sub-group within Group I

consists of 167 establishments that make

wieners and frankfurters. Eleven percent of

these establishments are combo plants, 67

percent are meat processors, and 22 percent

are poultry processors.

The third sub-group of 76 establishments

within Group I produce meat patties, some

partially or fully cooked; all are classified as

meat processors by the Census. Almost all

(98 percent) employ fewer than 500

employees.

The final sub-group in Group I consists of

191 establishments that make pastrami,

bologna, roast beef, bratwurst, bockwurst,

smoked hams and picnics, and smoked

poultry. Fifty-eight percent of the

establishments are meat processors; 16

percent, meat and poultry combo plants; and

26 percent, poultry processors. Overall,

eighty-nine percent are small to mid-sized

processors.

Group I also can be broken down into

groups by type of processing and whether

they produce meat or poultry products. As a

whole, 87 percent (507) are processors (421

meat and 86 poultry processors). Ninety-eight

percent of the meat processors are made up

of either very small (employing fewer than 10

employees) or small (employing more than

10, but fewer than 500 employees)

operations, with 36 percent being very small

and 62 percent being small operations. Only

2 percent of the establishments are

considered large (employing more than 500

employees). Poultry processors are structured

somewhat differently with 15 percent, being

very small; 49 percent, small; and, 36

percent, large. Combining both meat and

poultry processors gives a slightly different

picture of the structure of processing with 32

percent classified as very small; 60 percent,

small; and, 8 percent, large. The remaining

77 establishments (13 percent) in Group I are

combo plants (which slaughter animals and

process meat products). On average, these

establishments have a smaller scale of

operation than the group as a whole, with 53

percent being very small; 38 percent being

small; but 9 percent, being large.

Group II

These 791 establishments consist of just

over 50 percent of the total number of

establishments and produce about 45 percent

of total value of product shipments (boiled

hams, other smoked pork and poultry

products, other sausages, jellied goods, and

other meat and poultry products). Many of

these products are used in the manufacture

of other food products or sold to distributors

for direct use by consumers. Seventy percent

of these establishments are meat processors

(551); 20 percent (164) poultry processors;

and, 10 percent (76) combo plants.

Sub-group 1 of Group II is composed of the

551 meat processing establishments making

boiled hams, other sausages, and other frozen

or cooked meats, such as barbecue pork.

Sixty-two percent (339) of these

establishments are classified as small

operations. Two percent (12 establishments)

are large, while the reminder (36 percent or

200 establishments) are very small.

Sub-group 2 of Group II consists of the

twenty-percent (164) of the establishments

that are poultry processors. Forty-eight

percent (79) of these establishments are

classified as small operations. Fifteen percent

(25) are very small, while 37 percent (60) are

large operations. The main products

produced by these establishments include

jellied goods and other processed poultry

products.

The remaining 10 percent (76) of the

establishments in Group II are combo meat

plants (Sub-group 3). Seven percent (5) of

these establishments are classified as large

operations, while the majority (55%) are very

small and another 38 percent are small.

Group III

These 104 establishments make frozen

dinners, pizzas, meat and poultry pies, and

nationality foods containing meat and/or

poultry. They make up roughly 7 percent of

the total number of establishments and ship

out over 10 percent of the total value of

product shipments.

Group IV

These 151 establishments produce canned

products that contain meat and poultry

products. These establishments make up over

9 percent of the total number of

establishments and about 8 percent of the

total value of shipments.

B. Current Regulatory Environment

Currently, all environmental testing for

Listeria and the development of either a

Sanitation SOP measure or CCP for Listeria

is completely voluntary. Since 1987, FSIS

has conducted a microbiological testing

program in which the Agency randomly

samples, in-plant, RTE meat and poultry

products produced in federally inspected

establishments for L. monocytogenes,

including cooked and fermented sausages,

cooked corned beef, sliced ham and

luncheon meats, beef jerky, cooked uncured

poultry, and salads and spreads. FSIS treats

RTE products in which L. monocytogenes is

found as adulterated under the FMIA or the

PPIA (21 U.S.C. 453(g) or 601(m)).

A recent industry survey gives some

indication on the extent of current

environmental testing for Listeria.4 This

survey was conducted to determine what

types of actions establishments took in

response to the FSIS Federal Register Notice

of May 26, 1999 (64 FR 28351), asking

establishments that produce RTE meat and

poultry products to reassess their HACCP

plans to determine if L. monocytogenes was

a hazard reasonably likely to occur in their

processing. Because the respondents to this

survey represent only a small proportion of

the total number of establishment that would

affected by the proposed regulations, the

survey results may not reflect a

representative sample of the total population.

Nonetheless, these data represent the most

comprehensive available that reflects current

industry practices.

Approximately 308 establishments were

contacted for the survey. Of 271 respondents,

67 percent had an end-product testing

program for Listeria (88 percent of large

plants, 64 percent of small plants and 27

percent of very small plants). Over 90 percent

of the respondents conducted some type of

12624 Federal Register / Vol. 66, No. 39 / Tuesday, February 27, 2001 / Proposed Rules

environmental testing (100 percent of large

plants, 92 percent of small plants, and 41

percent of very small plants). These survey

results suggests that most large

establishments conduct both product and

environmental testing while many small and

very small firms do not.

The industry survey also found almost all

(97%) of the large establishments conducted

at least some type of environmental

microbiological testing before the

reassessment, but still, 39 of the 74 large

establishments, 58 of 193 small

establishments, and only one of 22 very small

establishments added a CCP to their HACCP

plan in response to the reassessment (Table

2).

TABLE 2.—ESTIMATED ESTABLISHMENTS ADDING LM CONTROL MEASURES AS A RESULT OF LM REASSESSMENT, SPRING

2000

Firm size Add CCP

addressing LM

Total number of

establishments

Percent Adding

LM-related measures to their

HACCP plans

Large .......................................................................................................................... 39 74 52.70

Small .......................................................................................................................... 58 193 30.05

Very Small ................................................................................................................. 1 22 4.55

Total .................................................................................................................... 98 289 33.91

Survey sponsored by: NFPA, AMI, NTF, NCC, NMA, NAMP, SMA, and AAMP.

The CCP addressing L. monocytogenes may

or may not have included testing, but

involved remedial type actions, such as

increased use of disinfectants on processing

surfaces. However, it does mean that more

than half of the establishments had not

included L. monocytogenes concerns in their

HACCP plan before reassessment even

though microbiological testing was being

conducted. Even after reassessment when

these additional establishments identified L.

monocytogenes concerns in their HACCP

plans, microbiological testing programs were

included in only 21 percent of the

establishments’ HACCP plans (or in 15

establishments’ HACCP plans) and 41

percent of the Sanitation SOPs of the

establishments in this size category (Table 3,

below).

TABLE 3.—PERCENT OF ESTABLISHMENTS SURVEYED WITH MICROBIOLOGICAL TESTING PROGRAMS AS PART OF EITHER

THEIR SANITATION SOPS OR HACCP PLANS, SPRING 2000

Firm size SSOPs HACCP Either SSOP

or HACCP

Large ............................................................................................................................................ 41 21 62

Small ............................................................................................................................................ 41 24 65

Very Small ................................................................................................................................... 60 25 85

Weighted Average ....................................................................................................................... 43 23 66

Survey sponsored by: NFPA, AMI, NTF, NCC, NMA, NAMP, SMA, and AAMP.

Over 80 percent of the small

establishments in the survey that conduct

some type of environmental microbiological

testing, did so prior to the reassessment.

After reassessment, 58 out of the 193 small

establishments added a CCP addressing L.

monocytogenes to their HACCP plans.

Microbiological testing was included as part

of 24 percent of these HACCP plans.

Microbiological testing was included in 41

percent of the Sanitation SOPs. Of the very

small establishments, only one added a CCP

addressing L. monocytogenes to their HACCP

plan out of the 22 establishments surveyed.

After reassessment, microbiological testing

programs were part of 25 percent of the

establishments’ HACCP plans in this size

category and 60 percent of the Sanitation

SOPs of the establishments in this size

category. In general, the survey results

suggest that many establishments have

identified L. monocytogenes as an important

pathogen of concern and have included

remedial measures in either their Sanitation

SOPs or CCPs in their HACCP plans and that

microbiological testing is more likely to be

incorporated in Sanitation SOPs than as part

of a CCP in a HACCP plan.

C. Baseline Number of Listeriosis Cases and

Deaths and the Potential Benefits From the

Proposed Rule

FSIS presents two baselines below for

potential benefits from the proposed rule.

The first baseline is derived entirely from the

FDA–FSIS draft risk assessment. The second

baseline is constructed from two

independent CDC-based studies. FSIS’’ intent

is to present a range of possible benefits.

Baseline 1

The baseline numbers of listeriosis cases

and deaths are taken directly from the recent

FDA–FSIS interagency draft risk assessment,

mainly Appendix 9, Table 1. The FDA–FSIS

draft risk assessment ranks 20 categories of

foods and provides a rigorous, systematic

assessment of the scientific knowledge to

predict the relative public health impact of

exposure to L. monocytogenes. The FDA–

FSIS draft risk assessment shows that the

following five factors affect the

contamination levels at the time of

consumption: (1) the frequency and extent of

contamination at retail; (2) consumption

habits; (3) the growth potential of L.

monocytogenes in foods; (4) consumer

storage practices; and (5) refrigeration

temperatures. The results of the FDA–FSIS

draft risk assessment estimates 2540 annual

median U.S. listeriosis cases of which 1659

(65.3 percent) are attributable to the

consumption of RTE meat and poultry

products.

The FDA–FSIS draft risk assessment not

only provides the most recent and complete

analysis on sporadic U.S. listeriosis cases by

general product group, but it also provides

insights into several commodities’ relative

risk rankings and their contribution to the

total U.S. number of listeriosis cases. Delimeats present the most prominent risk to all

sub-populations (Intermediate Age, Elderly,

and Perinatal), and are likely responsible for

1446 median U.S. listeriosis cases (58.9

percent of the U.S. total), or 88.9 percent of

the listeriosis cases attributable to RTE meat

and poultry products.

Other specific products within the meat

and poultry product category identified by

the FDA–FSIS draft interagency risk

assessment as posing a risk related to

listeriosis are: deli salads containing meat

and poultry products (at the median, 3.8% of

all listeriosis cases or 5.8% of listeriosis cases

attributable to RTE meat and poultry

products); frankfurters (at the median, 3.5

and 5.4 percent, of the total and all RTE meat

and poultry products listeriosis cases,

respectively); pate ́ (at the median, 0.9 and 1.4

percent, respectively, for total and all RTE

Federal Register / Vol. 66, No. 39 / Tuesday, February 27, 2001 / Proposed Rules 12625

5One-fourth of all deli salads consumed contain

RTE meat and poultry products based on the 1994–

1996 Continuing Survey of Food Intakes by

Individuals used in the FDA–FSIS interagency risk

assessment.

6The number of neonatal deaths was multiplied

by 2.5 to adjust the combined prenatal and neonatal

deaths to a case-fatality rate constrained at

approximately 20% in the FDA–FSIS interagency

risk assessment. This adjustment was made to

account for underreporting of prenatal infections

resulting in premature termination of pregnancy.

meat and poultry products listeriosis cases);

and, dry fermented sausage (at the median,

0.2 and 0.3 percent, respectively, for total

and all RTE meat and poultry products

listeriosis cases). The FDA–FSIS interagency

draft risk assessment model anchors the

median number of listeriosis cases on

epidemiologic surveillance data (FoodNet)

without bounding the 5th and 95th

percentiles of the estimated number of cases

attributable to each product category. Table

4, based on the FDA–FSIS interagency draft

risk assessment, provides the total number of

listeriosis cases across age groups for each

product category for the 5th and 95th

percentiles:

TABLE 4.—SUMMARY FDA–FSIS DRAFT RISK ASSESSMENT RESULTS CONCERNING TOTAL PREDICTED US LISTERIOSIS

CASES OF FOODBORNE ORIGIN

Product category

Statistics 1 Relative risk ranking 2 Etiologic fraction of cases attributed to each product category

at the 5th and 95th percentiles 5

As a percent

of total cases

in their product

class 5th 95th Med.4 123

5th 95th Med.

Smoked Seafood .............. 1 2464 33 6 6 7 1 1 61

Raw Seafood .................... 0 35 0 17 20 17 0 0 0

Preserved Fish ................. 0 300 3 13 13 13 0 0 6

Cooked Crustaceans ........ 0 1415 18 9 8 9 0 1 33

Total Seafood ................... 1 4214 54 Vary Vary Vary 1 2 100

Vegetables ....................... 0 7311 15 11 9 11 0 4 87

Fruits ................................ 0 900 2 16 14 14 0 1 13

Vegetables/Fruits ............. 0 8211 17 Vary Vary Vary 0 5 100

Dairy Products .................. 26 19481 523 Vary Vary Vary 28 12 NA

Frankfurters ...................... 3 6324 90 4 5 4 3 4 5

Dry/Semi-Dry Fermented

Sausages ...................... 0 631 5 12 12 12 0 0 0

Deli Meats ........................ 50 98261 1446 1 1 1 55 59 87

Paˆte ́ and meat spread ..... 1 1152 23 8 7 8 1 1 1

Meat or Poultry Deli

Salad 3 .......................... 3 7146 96 2 3 3 3 4 6

Total RTE Meat and Poultry Products .................. 57 113514 1660 Vary Vary Vary 62 68 100

Non-Meat or Poultry Deli

Salad ............................. 5 21437 287 2 3 3 2 13 NA

1 Horizonal summation of listeriosis cases across age group for each product category in Table 1, Appendix 9 of the FDA–FSIS interagency

draft risk assessment (page 342). 2 1= Intermediate; 2= Elderly; and, 3=Peri-natal. The relative risk ranking is taken directly from Table V–3 of the FDA–FSIS interagency draft

risk assessment (p. 108). 3 Meat deli salad estimate is based on FDA–FSIS draft risk assessment estimate of 26 deaths from deli salads and assuming that 25 percent

is due to deli salads containing meat and poultry product’s (their relative proportion of total deli salad consumption). 4 Med. = Median.

5The etiologic fraction is calculated as the proportion of listeriosis cases associated with each product category at the 5th and 95th percentiles.

The number of listeriosis cases attributable

to ready-to-eat meat and poultry products is

62% (1562 cases) at the 5th percentile and

68.0% (1727 cases) at the 95th percentile

based on a median number of annual cases

(2540 cases). This sensitivity about the

median number of listeriosis cases

attributable to meat and poultry products was

calculated by summing the number of

listeriosis cases attributable to each meat and

poultry product category (frankfurters, dry

and semi-dry sausage, deli meats, and pate

and meat spreads) and 25% (based on onefourth of all deli salad servings containing

meat and poultry products, CSFII 1994–1996

survey data) of the deli salad category 5 for

the 5th and 95th percentile. The total number

of listeriosis cases attributable to meat and

poultry products for each product category in

the 5th percentile was divided by the total

number of listeriosis cases for all RTE

products at the 5th percentile. A similar

calculation was done at the 95th percentile.

These etiologic fractions of the number of

listeriosis cases provide a plausible range for

the estimated number of listeriosis cases

attributable to RTE meat and poultry

products.

FDA–FSIS interagency draft risk

assessment reports results for three specific

age groups: perinatal (which includes fetuses

and newborns from 16 weeks after

fertilization to 30 days after birth), elderly

(which includes people 60 or more years of

age), and intermediate age (everyone else).

The FDA–FSIS interagency draft risk

assessment model predicts the number of

deaths associated with each RTE food

category. The estimated number of listeriosis

cases presented in the FDA–FSIS draft risk

assessment (Table 1, Appendix 9) is based on

the assumption of an overall case-fatality rate

of 0.20.6 This assumption is supported by a

study of foodborne illnesses in the United

States, Mead et al. (1999), which is based on

published reports and unpublished CDC

data, and is consistent with epidemiololgic

surveillance case-fatality data across all age

groups (Table 5).

12626 Federal Register / Vol. 66, No. 39 / Tuesday, February 27, 2001 / Proposed Rules

TABLE 5.—LISTERIA CASES BY AGE CLASS AND YEAR

Age class 1996 1997 1998 1999 1996–99 % Cases

Perinatal

adjustment

factor

0–1, unadjusted ................................................................... 8 5 10 12 35 ................ 2.5

Perinatal, adjusted ............................................................... 20 13 25 30 88 20 ................

1–9 ....................................................................................... 1 2 1 3 7 2 ................

10–19 ................................................................................... 3 1 2 1 7 2 ................

20–29 ................................................................................... 4 3 6 5 18 4 ................

30–39 ................................................................................... 6 9 13 7 35 8 ................

40–49 ................................................................................... 3 6 6 8 23 5 ................

50–59 ................................................................................... 4 9 13 16 42 10 ................

>60 ....................................................................................... 37 42 61 48 188 45 ................

‘‘Unknown’’ ........................................................................... 0 0 0 14 14 3 ................

Totals ............................................................................ 78 85 127 132 422 100 ................

There is some uncertainty surrounding the

assumed 20 case-fatality rate. The FDA-FSIS

interagency draft risk assessment observes

that if the susceptibility among the three agebased groups varies, then the ratio of serious

illness to mortality may differ among these

groups. This is consistent with epidemiologic

data for listeria mortality age distribution

unadjusted for underreporting and misclassification of pre-natal cases. Other

considerations include the fact that

epidemiolgic surveillance data do not count

unborn fetuses as deaths, but as miscarriages

and stillbirths, which may contribute to

underreporting within this age category

(PHS, 1994).

The epidemiologic data also contains cases

with an ‘‘unknown’’ age. In the 1999 data,

there were 14 cases reported as ‘‘unknowns.’’

Epidemiologists at the FoodNet sites

indicated that the ‘‘unknown’’ ages resulted

from database errors and are not a result of

a systematic classification error.

Table 6 presents the Listeria mortality age

distribution, unadjusted for the

underreporting or mis-classification of prenatal cases (the ‘‘unknowns’’ age cases were

not included in the data set). This unadjusted

data suggests and overall case-fatality rate of

15%, and substantial variation of the casefatality among the age categories.

TABLE 6.—LISTERIA MORTALITY AGE DISTRIBUTION, UNADJUSTED FOR UNDER-REPORTING OF PRE-NATAL CASES

Age class (yrs) Dead Total cases Mortality

0–1 ............................................................................................................................................... 1 23 4

1–9 ............................................................................................................................................... 0 4 0

10–19 ........................................................................................................................................... 0 6 0

20–29 ........................................................................................................................................... 0 13 0

30–39 ........................................................................................................................................... 1 28 4

40–49 ........................................................................................................................................... 3 15 20

50–59 ........................................................................................................................................... 4 26 15

>60 ............................................................................................................................................... 29 140 21

Totals .................................................................................................................................... 38 255 15

Source: FoodNet 1996–98, unpublished CDC data.

While it is unlikely that all of the

‘‘unknown’’ age cases would be in the

perinatal category due to National Health

Statistics standards for classification of fetal

deaths, a bound for the largest possible casefatality rate can be derived with the 14

‘‘unknown’’ age cases in this age category as

seen in Table 7.

TABLE 7.—LISTERIA MORTALITY AGE DISTRIBUTION, ADJUSTED FOR UNDER-REPORTING OF PRE-NATAL CASES

Age class (yrs) Dead Total cases % Mortality

Perinatal ....................................................................................................................................... 15 37 41

1–9 ............................................................................................................................................... 0 4 0

10–19 ........................................................................................................................................... 0 6 0

20–29 ........................................................................................................................................... 0 13 0

30–39 ........................................................................................................................................... 1 28 4

40–49 ........................................................................................................................................... 3 15 20

50–59 ........................................................................................................................................... 4 26 15

>60 ............................................................................................................................................... 29 140 21

Totals .................................................................................................................................... 52 269 19

Federal Register / Vol. 66, No. 39 / Tuesday, February 27, 2001 / Proposed Rules 12627

7Public Health Service, Medical Examiners’ and

Coroners’ Handbook on Death Registration and

Fetal Death Reporting. (Reprinted 1994).

8Olsen, Sonja, et al., ‘‘Surveillance for Food

borne Disease Outbreaks—United States, 1993–

1997,’’ Morbidity and Mortality Weekly Report,

March 17, 2000.

9Mead, Paul S., et al., ‘‘Food-Related Illness and

Death in the United States,’’ Emerging Infection

Diseases, 5:5, September–October, 1999.

10Originally, deaths were calculated using the

0.276 estimate, but was found to produce an

unrealistically high level of deaths. The 0.08

estimate produced results more in line with the

number of listeriosis deaths reported by Mead.

While the estimated overall case-fatality

rate of 19% is consistent with the Mead et

al. (1999) estimate of 20%, uncertainty

regarding the age-specific case-fatality rate

due to misclassification and underreporting

remain.7 Given disparate opinions on casefatality rates by age group, it is difficult to

come up with a point estimate for benefit of

this rule based on available data. However,

the following preliminary benefits analysis

provides two point estimates based on two

baseline approaches. It should be noted that

there is considerable uncertainty in the

benefits analysis below, which is recognized

throughout this section and again addressed

in the ‘‘Uncertainty’’ section.

Attaching Economic Value to the Number of

Listeriosis Cases and Deaths

The listeriosis cases and deaths attributable

to RTE meat and poultry products estimates

derived from the FDA–FSIS draft risk

assessment establish the number of lives lost

and those temporarily hospitalized or unable

to work as a result of illness. This cost may

be measured in lost productivity and in

medical costs incurred. The Economic

Research Service has conducted research on

the method. However, given many

uncertainties, FSIS is not monetizing the

values associated with reducing listeriosis

cases and deaths. FSIS requests comment on

appropriate methods to value listeriosis cases

and deaths.

Baseline 2

This second baseline derives the number of

listeriosis cases and deaths from two

independent studies: one by Olsen 8 and one

by Mead.9

The Olsen Study: Olsen estimated the

number of cases and deaths from all

foodborne diseases in several U.S. states and

found that meat and poultry products were

responsible for 8 to 20 percent of all

foodborne cases and deaths, respectively

(Table 8).

TABLE 8.—NUMBER OF U.S. FOOD BORNE DISEASE OUTBREAKS, CASES, AND DEATHS BY VEHICLE OF TRANSMISSION

Year

All known food borne diseases Meat and poultry products Percent attributable to meat and poultry

products

Outbreaks Cases Deaths Outbreaks Cases Deaths Outbreaks Cases Deaths

1993 ....... 489 17477 9 28 1797 5 6 10 56

1994 ....... 653 16234 3 51 1804 1 8 11 33

1995 ....... 628 17800 11 35 1144 1 6 6 9

1996 ....... 477 22607 4 23 992 0 5 4 0

1997 ....... 504 11940 2 31 972 0 6 8 0

Total 2751 86058 29 168 6709 7 6 8 24

5-yr Avg. 550 17212 6 33.6 1342 1 6 8 20

Source: Surveillance for Food borne Disease Outbreaks—United States, 1993–1997. Olsen, Sonja et al.—— See tables 17 to 21.

If the percentage of listeriosis cases and

deaths attributable to meat and poultry

products is the same as the percentage

attributable to foodborne diseases, the 8-

percent estimate from the Olsen study can be

used to estimate the number of listeriosis

cases and deaths due to consumption of RTE

meat and poultry products.10 This

assumption may not be accurate. Olsen’s

study is a summary of reported foodborne

disease outbreaks. However, FoodNet

surveillance data indicate that the majority of

listeriosis cases are sporadic with no

identified link to any other case.

Furthermore, sporadic disease may reflect

entirely different food vehicles, mechanisms,

or sources of infection than those responsible

for outbreaks.

With these reservations in mind, FSIS

applied the 8-percent estimate from the

Olsen study to the Mead data (2500 cases and

499 deaths) for listeriosis (after developing a

5-year time series set of estimated listeriosis

cases and deaths), which gave an average

annual listeriosis case and death load of 186

and 38, respectively (Table 9). For example,

the 1993 estimate of listeriosis cases and

deaths was calculated by multiplying 0.08

times 2359 (189) and 0.08 times 745 (60),

respectively for cases and deaths.

TABLE 9.—ESTIMATED NUMBER OF U.S. FOOD BORNE DISEASE CASES AND DEATHS: TOTAL FROM ALL PATHOGENS,

TOTAL FROM LM, TOTAL FROM LM IN RTE MEAT AND POULTRY PRODUCTS (MPP’S) FOOD PRODUCTS AS DERIVED

FROM A /COMBINATION OF THE MEAD-OLSEN STUDIES

Year

Cases and deaths

from all food borne

diseases

Listeriosis cases and

deaths through food

borne sources

Listeriosis cases and

deaths through MPP’s

Listeriosis cases and

deaths through RTE

MPP’s

Cases 1 Deaths Cases Deaths Cases Deaths Cases Deaths

1993 ................................................................. 11796975 2700 2359 745 189 60 170 54

1994 ................................................................. 10957950 900 2192 248 175 20 158 18

1995 ................................................................. 12015000 3300 2403 911 192 73 173 66

1996 ................................................................. 15259725 1200 3052 331 244 26 220 24

1997 ................................................................. 8059500 600 1612 166 129 13 116 12

Total 2 ........................................................ 58089150 8700 11618 2401 929 192 837 174

5-yr Avg. ........................................................... 11617830 1740 2324 480 186 38 167 35

1 It is assumed that the terms, illnesses as in Mead et al., and cases in Olsen et al., report, can be used interchangeably.

2 May not add due to rounding.

12628 Federal Register / Vol. 66, No. 39 / Tuesday, February 27, 2001 / Proposed Rules

11These numbers are derived from the total

number of firms listed in Table 3 of section XII of

the proposed rule preamble, ‘‘Compliance with

Regulatory Flexibility Act of 1966.’’

Finally, the estimated number of cases and

deaths due to listeriosis attributable to meat

and poultry product consumption must

reflect only that portion that is RTE. One

method to do this is simply to assume that

90 percent of the meat and poultry product

listeriosis cases and deaths are linked to RTE

food products. Obviously this estimate is

completely arbitrary. FSIS does not contend

that this is an accurate depiction: therefore,

FSIS solicits comments. Using this estimate,

the number of listeriosis cases and deaths

attributable to RTE meat and poultry product

consumption is estimated at 167 and 35,

respectively. Also, FSIS considered making

an adjustment factor for the effectiveness of

the provisions in the proposed rule. Again,

FSIS is unsure how such an adjustment

factor would be constructed, but recognizes

that not all listeriosis cases and deaths could

be totally eliminated by provisions in the

proposed rule. FSIS requests comment on the

efficacy of the proposed testing provisions.

Request for Comment

FSIS solicits comments and suggestions

concerning the issues of the baseline number

of listeriosis cases and deaths attributable to

RTE meat and poultry products and the

effectiveness of measures prescribed by the

proposed rule. Notably, the recent FDA–FSIS

draft risk assessment estimated that 65.3

percent of all U.S. listeriosis cases and deaths

(or 1660 cases and 322 deaths per year) are

attributable to the consumption of RTE meat

and poultry products. The number of cases

and deaths estimated by the FDA–FSIS draft

risk assessment are 9.9 times greater than the

estimated numbers obtained from the second

baseline. FSIS welcomes comments and

suggestions on the kinds of data and

information needed to construct alternative

baselines and sensitivity approaches to test

baseline listeriosis cases and deaths and

program effectiveness.

Projected Industry Costs

1. Mandatory Food Contact Surface Testing

for Listeria spp.

FSIS is proposing to require that all

establishments that produce RTE meat and

poultry products conduct environmental

testing of food-contact surfaces for Listeria

spp., after lethality treatment and before final

product packaging, unless they have

identified L. monocytogenes as a hazard

reasonably likely to occur and so have

incorporated into their HACCP systems one

or more controls validated to eliminate it

from their products. This testing will verify

that an establishment’s Sanitation SOPs are

preventing direct product contamination by

L. monocytogenes after the lethality

treatment, thus addressing the risk

assessment assertion that RTE foods often are

recontaminated by L. monocytogenes after

lethality is applied.

After an establishment finds one of its food

contact surfaces to be positive for Listeria

spp., it must take corrective actions defined

in its Sanitation SOPs that must include

product testing, as well as any other activities

that it deems necessary to determine and

demonstrate that the affected lot or lots of

product are not adulterated with L.

monocytogenes. The establishment must

have in place procedures: to determine

which lots of product might be affected; to

hold, sample, and test that product; and to

dispose of affected product appropriately.

Establishments can be expected to face at

least three potential cost impacts due to

mandatory food contact surface testing for

Listeria spp. testing. These potential impacts

could arise from: (1) the need to make major

revisions in their HACCP plan(s); (2)

additional verification testing; and, (3) the

need to make major changes in their

production process and/or production output

mix.

The first and second impacts are closely

related because the firms that elect to revise

their HACCP plan to incorporate a CCP

addressing Listeria will not be required to

test for it at the prescribed level for those

incorporating Listeria testing in the

Sanitation SOPs. HACCP provides the

opportunity for greater latitude in

establishing more science-based verification

approaches, which may include testing.

Thus, some estimate on the number of firms

expected to incorporate a CCP addressing

Listeria as a result of this provision is

necessary for this analysis to proceed. The

higher this estimate, the higher will be the

expected costs to validate needed HACCP

modifications, and lower will be the

expected costs of the proposed testing

requirements.

The third impact stems from the decision

by some establishments to drop certain RTE

meat and poultry products (or drop out of

production altogether). This decision would

be due to persistently high rates of positive

Listeria spp. food contact surface testing

results and the subsequent increased amount

of product being held while awaiting

confirmation that positive food contact

surface test results for Listeria spp. did not

result in contaminated product.

This creates the prospect of an additional

fourth potential impact: the potential

increased cost associated with greater

volumes of product held by establishments in

a ‘‘test and hold’’ pattern. These costs are

expected to be particularly relevant to those

firms experiencing very poor testing results,

presumably as a result of inadequate

sanitation controls. These costs are discussed

separately in the section entitled ‘‘C.

Projected Costs Associated with Expected

Production Adjustments.’’ There, FSIS

explains that establishments that encounter

‘‘Stage 2’’ and ‘‘Stage 3’’ type problems with

chronic Listeria spp. or L. monocytogenes

contamination either incur substantial

remediation costs or elect to exit RTE meat

and poultry product production. FSIS lacks

data to adequately estimate the volumes of

product that establishments may have to test

and hold and the resulting costs. See the

section entitled ‘‘Uncertainty’’ for further

discussion.

Each of the three cost impacts is discussed

below.

A. Projected Costs Associated With HACCP

Plan Validation

FSIS estimates that currently 397

establishments have a CCP addressing

Listeria in their HACCP plan and that 257

additional establishments will do so as a

result of the proposed rule. That is, the

number of establishments with a CCP

addressing L. monocytogenes is projected to

increase nearly 65 percent as a result of this

provision of the proposed rule (from 397 to

654). FSIS bases these estimates on judgment

and information presented previously in the

discussion on baseline industry practices.

Main factors considered in FSIS’s estimates

pertaining to current and projected behavior

related to firms’ decision to modify their

HACCP plans include:

• FSIS estimates that the percentage of the

large establishments, excluding canners, that

have a CCP addressing L. monocytogenes in

their HACCP plans will increase from 50 to

100 percent (from 67 establishments to 133

establishments) 11 as a result of the proposed

rule;

• FSIS estimates that the percentage of the

small establishments, excluding canners, that

have a CCP addressing L. monocytogenes in

their HACCP plans will increase from 33 to

50 percent (from 280 establishments to 420

establishments) as a result of the proposed

rule; and,

• FSIS estimates that the percentage of the

very small establishments, excluding

canners, that have a CCP addressing L.

monocytogenes in their HACCP plans will

increase from 10 to 20 (from 51

establishments to 101 establishments)

percent as a result of the proposed rule.

The net results on the number of

establishments with a CCP addressing

Listeria in response to the proposed rule is

given in Table 10 below. FSIS has excluded

canners from total in the following table

(resulting in a grand total of 1479: 1630 total

minus 151 canners). FSIS expects that

canners should only experience minimal

costs from identifying that their existing

CCPs already eliminate L. monocytogenes

from their products.

Federal Register / Vol. 66, No. 39 / Tuesday, February 27, 2001 / Proposed Rules 12629

12This increase in this field is due to the number

of establishments currently testing that choose to

also develop a CCP in response to the rule. FSIS

assumes that they will continue testing, so this

number does not represent an increase in the

number of establishments that test.

13 It must be kept in mind that although larger

establishments will avoid mandatory testing at the

prescribed frequency, nothing suggests that these

establishments will discontinue their testing

programs and jeopardize their product integrity. It

is expected that the original product integrity be

maintained through its own HACCP monitoring and

verification activities and confirmed through FSIS

verification of their HACCP plans.

14 Guidelines to Prevent Post-Processing

Contamination from LM, Tompkin, Scott, Bernard,

Sveum and Gombas, Dairy, Food and

Environmental Sanitation, August 1999, Vol. 19,

No. 8, Pages 551–562.

15Why lines? Many authorities recommend

considering each product line as a critical control

point. For example, ‘‘Each packaging line should be

regarded as an independent unit for LM monitoring

Continued

TABLE 10.—SUMMARY OF CURRENT AND PROJECTED ESTABLISHMENT BEHAVIOR WITH RESPECT TO THEIR DECISION TO

INCORPORATE A CCP ADDRESSING L MONOCYTOGENES

Item

Number of establishments

Change

Before After

Establishments that currently have or will develop a CCP addressing L. monocytogenes in their HACCP plan that also:

Conduct food contact surface testing .......................................................................................... 299 12 489 190

Do not conduct food contact surface testing ............................................................................... 98 165 67

Sub-total ............................................................................................................................... 397 654 257

Establishments without and that will not develop a CCP addressing L monocytogenes in their HACCP plan that also:

Conduct food contact surface testing .......................................................................................... 645 825 180

Do not conduct food contact surface testing ............................................................................... 437 0 ¥437

Sub-total ............................................................................................................................... 1082 825 ¥257

Grand-Total ................................................................................................................... 1479 1479 0

The size distribution of establishments

expected to modify their HACCP plans has

important implications in the analysis on

mandatory food contact surface testing. This

analysis assumes that all large establishments

are likely to incorporate a CCP addressing L.

monocytogenes in their HACCP plans, while

most small and very small establishments

will not (instead relying on Sanitation SOPs

to address L. monocytogenes and comply by

mandatory testing). That is, larger

establishments (who have the greatest

volume, currently conduct a high volume of

product and food contact surface

microbiological testing and maintain CCPs

addressing L. monocytogenes) will not be

required to test, thus reducing the overall

testing brunt of this provision. The current

high numbers of large establishments with

CCPs addressing L. monocytogenes, and the

expectation that all remaining ones will

modify their HACCP plans strongly influence

this outcome.13 This leaves the smaller

establishments to feel the brunt of mandatory

food contact surface testing burden while at

the same time, lowering the total level of

testing needed to comply with the proposed

rule.

One element that may increase the over-all

cost of the HACCP modification component

of mandatory testing at the prescribed

frequency is if establishments need to modify

more than one HACCP plan. Also, the

relative of cost of testing versus developing

a CCP would not be the only factor in an

establishment’s decision on how to comply

with the proposed requirement. Unique

aspects of ad establishment’s processing

system, as well as the relative risks posed by

its products, may influence an

establishment’s decision. FSIS request

comment on this issue.

FSIS has found that the costs associated

with modification of HACCP plans can range

from $2,000 to $20,000 per HACCP process.

This cost depends on the efforts needed to

draw up new CCPs (sanitation practices to

limit levels of L. monocytogenes on incoming

raw product and prevent recontamination

after processing, lethality steps, or testing to

validate and verify its controls); install

monitoring equipment (thermometers and

test kits) and; train labor to take additional

samples and to keep records. The cost of

$5000 for the incorporation of a CCP

addressing L. monocytogenes into an

establishment’s HACCP plan is used in cost

projections for this analysis, regardless of

size of establishment or number of HACCP

plans per establishments. This cost is

considered a one-time event (minimal

recurring monitoring costs are assumed to

result from the inclusion of a CCP addressing

L. monocytogenes). Any additional costs

associated with its’ monitoring are subsumed

in the over-all monitoring cost of the

establishment’s current HACCP plan(s).

Industry-wide, these total one-time HACCP

validation costs are estimated at $1.285

million ($5000 times 257 establishments).

FSIS requests comment on this estimated

total cost of HACCP plan modification.

B. Projected Costs Associated With

Additional Testing

For those establishments not currently

testing or that do not maintain a CCP

addressing Listeria, FSIS tentatively

concludes that food contact surface testing

and Sanitation SOP controls will supply the

same reassurance that L. monocytogenes is

not a potential food safety problem as do

regularly scheduled verifications of

Sanitation SOPs. As was discussed, the

proposed rule effectively exempts

establishments from mandatory testing if: (1)

they manufacture products whose processing

destroys L. monocytogenes and/or eliminates

any opportunity of recontamination, e.g.,

canners; or (2), if they previously identified

L. monocytogenes as a hazard reasonably

likely to occur and have incorporated one or

more controls into their HACCP systems.

These two conditions effectively exempts 151

establishments identified as canners and 397

establishments identified as currently having

a CCP addressing L. monocytogenes in their

HACCP plan. In addition, FSIS projects that

an additional 257 establishments will elect to

incorporate a CCP addressing L.

monocytogenes into their HACCP plan,

effectively avoiding this mandatory testing

requirement. Thus, FSIS estimates that this

provision will impose mandatory testing

costs on 825 establishments

(1630¥151¥397¥257=825).

Nature of Testing (Areas to be tested,

Frequency, and Consequences). All

environmental tests will be made on foodcontact surfaces (rather than non-food

contact surfaces, such as floors and drains).

Reliance on food contact surface testing is

predicated on the logic that establishments,

in the desire to minimize their chances of

having a positive food product test, will use

surface test results as a leading indicator of

food product safety. Thus, no non-food

product contact testing is required in this

proposed rule change. Also, non-food

product contact has not been found to be

related with final product safety: ‘‘Areas

where products are stored or processed are of

lower priority because inadequately cleaned

equipment in raw processing areas have not

been associated with a problem of Listeria

monocytogenes in finished product.’’ 14

The frequency of food contact surface

testing is based on the following:

(a) Four tests per active line 15 per month

for large establishments;

12630 Federal Register / Vol. 66, No. 39 / Tuesday, February 27, 2001 / Proposed Rules

and control,’’ Guidelines to Prevent Post-Processing

Contamination from LM, pp. 551–562. 16The higher testing frequency for large

establishments (once per week per line) also reflects

the greater potential of large establishments to

contaminate larger volumes of product than small

and very small establishments.

17No adjustment is made to account for the

degree to which plants currently test: the baseline

discussion suggests that many firms are currently

conducting some kind of environmental testing

program.

18This increase in this field is due to the number

of establishments currently testing that choose to

also develop a CCP in response to the rule. FSIS

assumes that they will continue testing, so this

number does not represent an increase in testing.

19 Guidelines to Prevent Post-Processing

Contamination from LM, 1999.

(b) Two tests per active line per month

period for small establishments; and,

(c) One test per active line per month for

very small establishments.

For purposes of this cost analysis below,

FSIS used the following assumptions on the

average number of operating lines per

establishment: 2 lines for very small

establishments; 4 lines for small

establishments; and, 6 lines for large

establishments.

These frequencies are intended to be the

minimum level of food contact surface

testing undertaken by firms. Greater

frequency of testing by establishments

(regardless of size) is encouraged by FSIS:

FSIS policy states that the more the plant is

testing, the less likely FSIS will include the

plant’s product in its end-product

microbiological testing program(s) (FSIS

Directive 10,240.2, Revision 1). This testing

frequency incorporates the volume of

production in two ways: (1) It assumes that

the more an establishment produces, the

more lines it has, and (2) the greater its size,

the more product is produced and thus, a

need for higher weekly frequency as size

increases.16 FSIS requests comment on these

proposed testing frequencies.

Positive test results on food-contact areas

will indicate a need to thoroughly clean the

immediate working areas and equipment and

re-test. Once a positive food contact surface

is found, product samples will be tested for

L. monocytogenes. The establishment must

have in place procedures to determine which

lots of product might be affected; to hold,

sample, and test that product; and to dispose

of affected product and to correct and

prevent further contamination appropriately.

The potential cost of mandatory testing is

a function of the per-unit testing cost 17 and

of the number of establishments (and the

number of lines that each establishment

maintains) that are affected by this provision.

Several testing firms were contacted

concerning their testing kits for Listeria spp.

The cost of these tests varied from $10 to $30,

not including the costs for labor and shipping

the material to the laboratory. One would

expect that the costs of in-house testing

would be at least the amount charged by

firms engaged in providing this service. A

slightly higher cost of $35 per test is used as

the average cost of testing food-contact areas

for Listeria spp. in this analysis to

compensate for expenses associated with

labor to conduct the test and shipping tests

to laboratories for analysis.

The number of establishments that will

face mandatory testing has been determined

in the previous analysis. Recall that it found

that all large establishments are expected to

modify their HACCP plans and be exempt

from mandatory food contact surface testing.

The finding implies that only small and very

small establishments will need to test to

satisfy compliance of the proposed rule. FSIS

estimates that 50,035 tests will be needed by

these establishments (Table 11). The

associated overall costs of these tests is

estimated at $1.75 million ($35 times 50,035).

This cost would be expected to recur

annually.

TABLE 11.—SUMMARY OF NUMBER OF TESTS CONDUCTED BY ESTABLISHMENTS WITH AND WITHOUT CCPS ADDRESSING

L. MONOCYTOGENES

Item

Number of tests needed to

meet compliance Change

Before After

Establishments that currently have or will develop a CCP addressing L. monocytogenes in their HACCP plan that also:

Conduct food contact surface testing .......................................................................................... 39105 18 67458 +28353

Do not conduct food contact surface testing ............................................................................... 8141 13594 + 5453

Sub-total 1 ............................................................................................................................ 47246 81053 + 33807

Establishments currently without and that will not develop a CCP addressing Listeria monocytogenes in their HACCP plan that also:

Conduct food contact surface testing .......................................................................................... 63524 50035 ¥13489

Do not conduct food contact surface testing ............................................................................... 20318 0 ¥20318

Sub-total 2 ............................................................................................................................ 83842 50035 ¥33807

Grand-Total (1+2) .......................................................................................................... 131088 131088 0

C. Projected Costs Associated With Expected

Production Adjustments

In addition to the above two expected

industry costs (administrative costs related to

incorporating a CCP addressing L.

monocytogenes in their HACCP plans and

increased food contact surface testing costs),

some firms—across all size categories—may

need to adjust their production process or

facilities to comply with the proposed rule.

One can view such adjustments as being on

a continuum, from the most minor—and least

costly—to the most radical—and costly—

adjustments needed to remedy their L.

monocytogenes-related control problem(s).

Because measures vary greatly across

establishments and product-types, it is

difficult to estimate the impact of eventual

firm adjustments arising from this provision

of the proposed rule.

For purposes of analysis, affected

establishments are broken into four groups:

those that are not expected to encounter any

problems as a result of mandatory testing;

those firms that are expected to encounter

minor problems (Stage 1 problems); those

firms that are expected to encounter more

serious problems and higher costs to remedy

their L. monocytogenes-related problems

(Stage 2 problems); and, a small group that

will drop certain products or drop

production entirely due to persistent L.

monocytogenes positive findings (Stage 3

problems). Based on the discussion that

follows, the number of establishments in

each group was determined to be: 1,258

establishments that will not encounter any

problems; 104 establishments that will

encounter Stage 1 and 2 problems and 13

establishments that drop production of

certain RTE meat and poultry products or

drop out of the industry entirely (Table 12).

Steps to prevent L. monocytogenes

contamination can take many forms: preoperational (building and facility design;

equipment design and maintenance) and

operational (adequate attention paid by welltrained employees). Most establishments are

assumed to follow the recommended

guidelines in production,19 are already doing

some testing (either food contact surface or

Federal Register / Vol. 66, No. 39 / Tuesday, February 27, 2001 / Proposed Rules 12631

20Further data analysis is needed to more

accurately estimate this figure. The current estimate

is based on MARCIS data on follow-up LM positive

finding for only one year of data (1999). This first

group of producers are assumed to represent the 85

percent of initial positive microbiological survey

samples that quickly rectified their contamination

problems in 1999. The latter stages reflect smaller

and smaller percentages of the initial positive

samples that required more and more follow-up

tests because their test results persisted positive.

21Some increase in sanitation supplies and

materials are also expected.

22Further examples can be found in: Industry

Perspectives on LM in Foods: Manufacturing and

Processing, Bernard and Sveum, Dairy, Food and

Environmental Sanitation, Vol. 14, No. 3, Pages

140–143 (March 1994).

23Tappero, Jordan, Anne Schuchat, Katherine

Deaver, Laurene Mascola and Jay Wanger,

Reduction in the Incidence of Human Listeriosis in

the United States, Effectiveness of Preventive

Efforts?, JAMA, April 12, 1995—Vol. 273, No. 14.

This study actually put the costs at the range of 0.1

to 0.2 of annual industry sales.

24 It is also acknowledged that increased numbers

of positive environmental tests may result in

increased numbers of positive product tests, leading

in turn, to not only increased amount of product

destroyed, but increased amounts of product that

need to be held until results are complete and in

the case of positives, increased amount of products

that need to be reworked.

of products), and would not be expected to

experience any increase in positive food

contact surface testing results as a result of

the proposed regulation changes. FSIS

estimates that eighty-five percent 20 (1,258) of

the establishments will incur no costs,

because these establishments already have

taken steps to remediate problems with L.

monocytogenes contamination in product.

However, it is possible that these

establishments may have future problems

with environmental contamination by

Listeria spp. So, FSIS may have

overestimated the number of establishments

that will incur no future costs as a result of

the proposed requirements.

TABLE 12.—NUMBER OF ESTABLISHMENTS AND ASSOCIATED COSTS OF POTENTIAL PRODUCTION ADJUSTMENTS WITH

RESPECT TO MANDATORY LM TESTING

Group/subgroup Representative meat and poultry products

Problem category (by # of establishments) Associated

cost to control

LM problem

(000’s $)

Value of

discontinued

production on

(mil $) None

Stage

Total

123

I–1 ............... Fermented; Dried; and, Salt cured Products 127 11 11 1 150 181.6 1 5.9

I–2 ............... Frankfurters and wieners ............................... 142 12 12 1 167 248.1 23.6

I–3 ............... Meat patties .................................................... 65 5 5 1 76 72.5 5.3

I–4 ............... Luncheon meats ............................................. 163 13 13 2 191 519.0 60.5

II–1 .............. Otherwise processed M&P RTE product by

meat processors.

468 39 39 5 551 597.7 48.8

II–2 .............. Otherwise processed M&P RTE product by

poultry processors.

139 12 12 1 164 570.4 66.9

II–3 .............. Otherwise processed M&P RTE product by

combo plants.

65 5 5 1 76 99.3 9.6

III ................. Frozen dinners and pizzas ............................. 89 7 7 1 104 201.9 21.6

IV ................. Canned products ............................................ 0 0 0 0 0 0 0

Grand total ......................................................................... 1258 104 104 13 1479 2490.5 252.2

Some establishments follow the

recommended guidelines in production but,

for any number of reasons, are expected to

face difficulties in improving their L.

monocytogenes testing results.

Establishments that encounter Stage 1

problems would face only marginal

difficulties in improving their Listeria spp.

testing results. Seven percent of the

establishments (104) are expected to fall into

a this group. FSIS expects that these plants

can reduce these positive findings by

concentrating mainly on the pre-operational

component of the business,21 perhaps taking

more care in pre-operational sanitation and

better training of and increased awareness by

production personnel. Also, one could expect

that some ‘‘quick-fixes’’ to equipment, such

as finding the niches in equipment which

may harbor L. monocytogenes and cleaning

them thoroughly and more regularly, might

greatly reduce their positive food contact

surface testing results. Actions that are

expected correspond roughly to the response

by industry in a recent survey pertaining to

what actions are taken by establishments

when they exceed limits on results from

environmental testing. These include:

• Enhance pre-operational and operational

sanitation controls in production (262 out of

308 establishments that responded to the

industry survey cited previously indicated

that this action was taken when allowable

environmental testing results were

exceeded);

• Implement an environmental monitoring

program for Listeria spp. to verify that the

control program is effective (241 out of 302

surveyed indicated that this action was taken

when allowable environmental testing results

were exceeded);

• Intensify training efforts on personnel

(232 out of 302 surveyed indicated that this

action was taken when allowable

environmental testing results were

exceeded);

• Purchase inputs from suppliers with a L.

monocytogenes control program, and;

• Apply a validated listericidal process

where appropriate.

FSIS expects that plants encountering

Stage 1-type problems will face a $2000 per

line average ‘‘fix’’ for equipment and

machinery. These efforts are expected to be

effective and not involve any recurring cost.

Across all affected establishments, such costs

are expected to total $0.7 million.

An additional 7-percent of all

establishments (104) are expected to face

significantly greater difficulty in improving

their food contact surface Listeria spp. testing

results: ‘‘Stage 2-type’’ problems that can not

be solved simply by increased attention to

pre-operational sanitation efforts. These

plants must instead concentrate on

equipment and building re-design and other

manageable ‘‘technical fixes’’. By their

nature, these one-time efforts are more costly.

Examples of the kind of efforts envisioned

with these adjustments are: addition of postprocessing pasteurization equipment, redesigned drains, walls, and floor areas,

especially in the post-processing rooms, and

other major renovations to buildings and

equipment.22

FSIS expects that plants encountering

Stage-2 type problems will face higher costs

than establishments facing Stage-1 problems.

Based on expenses incurred by the industry

in taking similar steps in the early 1990’s,

FSIS estimates that such efforts could cost

the affected establishments 0.1 percent of

their gross sales.23 Some product losses from

these firms are expected due to greater

amounts of product held from commercial

channels because of positive food contact

surface tests for Listeria spp. or positive

product test results for L. monocytogenes.24

Such product losses are expected to diminish

after 6 months. Thus, such temporary

production drops and possible disruptions

are not considered throughout this analysis.

FSIS request comment on the costs of

holding and testing product for L.

monocytogenes contamination. Keeping this

in mind, FSIS projects that the total expenses

12632 Federal Register / Vol. 66, No. 39 / Tuesday, February 27, 2001 / Proposed Rules

25 It is misleading to attribute all of the reason for

the one percent decline in firm numbers on the

proposed rule. Some number of firms would have

gone out of production due to competitive reasons

and dynamics involved in industry technological

change. Regardless of the regulatory environment,

some level of technology will be adopted by some

firms and not by others; in addition, technology

may be made available to control LM in RTE food

processing during the time frame of this analysis.

If this technology is size-neutral, projections

concerning industry response to the proposed

regulation is problematic. On an optimistic note,

impacts may be dampened considerably by such

technology adoption. Examples of technology that

is being developed (and may be scale-neutral)

include: antimicrobial packaging, high pressure

processing, irradiation, oscillating magnetic fields,

pulsed electric fields, and UV light (Meat and

Poultry, April 2000, Post-processing pasteurization,

Preventing recontamination requires an aseptic

approach). However, impacts may be greater if

technology does not advance and Listeria control is

more of a function of pre-operational perquisites,

like building re-design and layout. Due to the great

amount of uncertainty related to this issue, no

assumptions were made concerning these off-setting

influences. However, the one-percent level was

used to indicate that some number of plants may

drop out of production as a result of the proposed

rule.

26 Given time, further analysis may reveal that the

probability of such Positive Microbiological Survey

Finding’s are associated with certain Meat and

poultry products, plant age or size, or other major

characteristic(s), i.e. season. Recall and other

internal FSIS data were investigated and no single

characteristic was found to explain MPSF

occurrence and/or frequency.

27Using an assumed average level of production

for each establishment of 50, 5, and 2 million

pounds for large, small, and very small

establishments, respectively, in each affected subgroup times the number of affected establishments.

28These implicit costs are associated with

production drag—increased levels of recalls, higher

rejection rates in production, slower production

shifts, slower sales due to perceived poorer quality

and such. Ideally they should be counted as a

separate effect associated with a possible leftward

shift in supply. At this time, there is not sufficient

data to quantify this effect.

associated with Stage 2 corrective actions

across the industry at $1.7 million. In total,

corrective actions associated for both Stage 1

and 2 type problems are expected to cost $2.5

million in one-time costs.

A final group of plants is expected to face

Stage 3-type problems: problems that

establishments may perceive to be

prohibitively costly to ‘‘fix’’ and/or not

feasible to undertake without complete

modernization or renovation. Without

making the needed capital investments, their

only option is to drop out of production. This

may involve dropping just the RTE meat and

poultry product component of their business

or eliminating RTE meat and poultry

products altogether.25 FSIS estimates that

one percent of all establishments (13)

regardless of size category 26 will fall into this

category. Resources, associated with the

associated discontinued production, are

expected to be absorbed by their next-best

use, such as frozen not-RTE food and other

food manufacturing. The value of the initial

drop in production across the industry is

estimated at $252 million. Although firm

numbers may drop by 1-percent, this initial

drop in production would not be expected

persist over time. Market supplies would be

expected to increase due to likely production

increases by the remaining domestic

establishments and possibly by increased

imports of similar type meat and poultry

products.

FSIS realizes that many of the

technological ‘‘fixes’’ that many

establishments may have to undertake are not

scale-neutral (they favor increasing scale

establishments). Thus, one may discover that

small and very small establishments are

disproportionately affected by this provision

of the proposed rule. However, to ensure

maximum food safety benefits from testing,

FSIS is proposing to require industry-wide

adoption. FSIS requests comments on

expected impacts on small and very small

establishments.

The total cost of mandatory food contact

surface testing on this industry is estimated

at $5.53 million ($1.28 million on HACCP

plan modification, $1.75 million on testing,

and $2.5 million in production adjustment

costs).

2. Costs Associated With Lethality and

Stabilization Performance Standards

This provision, as described in the

provisions section, mirrors the recently

published performance standards for the

production of cooked beef, roast beef, cooked

corned beef products, fully and partially

cooked poultry products (64 FR 732).

However, that rule did not apply to dried,

fermented, and salt-cured RTE meat and

poultry products. Fermented sausage makers

were advised in the mid-1990’s on methods

to ensure food safety and most of these

processors made changes to their production

at that time; however, this is not known for

sure. Also, the current proposed rule would

increase the required level of pathogen

reduction in meat patties. As such,

processors of meat patties and the dried,

fermented, and salt-cured RTE meat and

poultry products are expected to feel the

major impact from this provision of the

proposed rule. FSIS expects that this

provision may have two potential impacts on

certain RTE meat and poultry product

producers: (1) the need to make production

changes to attain the higher performance

standards and (2) the need to incorporate

increased monitoring equipment and other

means to validate that they are meeting the

new performance standards.

A. Projected Costs Associated With

Production Adjustments

The majority of the establishments that

produce RTE meat and poultry products are

not expected to be affected by the lethality

and stabilization provisions of the proposed

rule. Most establishments already may meet

these requirements because they are identical

to those in the final rule that established

performance standards for the production of

certain RTE meat and poultry products (64

FR 732). However, it is expected that onethird of the plants in Group I, Subgroup 1

(Dried, Salt-cured and Fermented Sausage

makers) and one-third of Group I, Subgroup

3 (meat patty makers) will be affected by this

provision of the proposed rule. FSIS

estimates that these 75 establishments or less

than 5 percent of the establishments in this

industry produce about 441 million pounds

of product.27

FSIS expects that producers will adjust to

higher performance standards by applying

some additional heating or holding times to

their products or by relying upon integrated

lethality involving multiple hurdles or

accounting for come-up and come-down

time. FSIS tentatively concludes that many

establishments would meet the proposed

performance standards using current

procedures; however, the integrated

cumulative lethality of these procedures may

not have been fully assessed at this time.

Individual establishments’ costs could vary

greatly depending on their need to purchase

capital equipment, such as flash freezers for

quicker cooling times, new heating

equipment, etc., that may lead to increased

costs in the short run, but lower operating

costs and improved product in the long run.

FSIS expects that most establishments will

continue to produce their products in much

the same way, but may increase their heating

temperatures and holding times. In so doing,

they are expected to experience somewhat

reduced production line speeds, initially

higher product rejection rates, and slightly

lower annual production.28

FSIS has only limited data to base its

estimate for the impact of higher performance

standard. Some anecdotal information

suggests that some establishments, to attain

the new lethality performance standards,

may have to incur an additional cent per

pound of product produced. This estimate

implicitly incorporates the cost of reduced

annual sales by the firm due to slower line

speeds (and its implicit effect on lost value

of production), equipment costs, and higher

energy costs. At this time, this one-cent per

pound cost is used in this analysis. FSIS uses

this per-pound estimate and its estimate on

affected poundage of product to project an

aggregate annual recurring cost of $4.4

million ($0.01 times 441.1 million pounds).

B. Projected Cost Associated With

Performance Standard Validation

The 75 establishments identified above are

expected to need a one-time validation to

determine if they are meeting the higher

performance standards. FSIS estimates that

these firms produce, at least, 545 specific

product-types that would need lethality and

stabilization validation. FSIS expects that the

costs to validate the attainment of

performance standards to be the same as the

validation of a HACCP plan modification

($5000). Thus, FSIS estimates that the overall cost to establishments to validate that they

are attaining the higher performance

standards for these products at $2.7 million

(545 times $5000).

Projected Costs Associated With Label

Changes. FSIS is proposing that the labeling

of RTE products state that the product

requires refrigeration after opening, as

applicable. Current regulations require that

labels of perishable products include such

instructions, but the Agency is proposing to

expand the required label instructions to

include RTE shelf-stable products that

require refrigeration after opening. For

Federal Register / Vol. 66, No. 39 / Tuesday, February 27, 2001 / Proposed Rules 12633

29Recall that the benefits from producers

complying with the higher performance standards

are not quantified at this time. Also, refer to the uncertainty discussion for an explanation of factors

that may lead to underestimation problems.

products that would be covered by this

provision, FSIS estimates that the costs per

label would be comparable to those for

printing safe handling labels ($0.0025 to

$0.05 per label if the information is included

as part of their price label, and, $0.01 per

label if they developed separate labels) (see

58 FR 58924). FSIS requests comment on the

costs and benefits of this labeling provision.

Projected Benefits From the Proposed Rule

All the benefits from this proposed rule are

generated by producers’ actions complying

with the mandatory food contact surface

Listeria testing and the HACCP plan

provisions of the proposed rule.29

Benefits are expected to accrue gradually

over time. Although studies found in the

literature suggests that L. monocytogenes

control measures take about 6 months to 2

years before they are successful, FSIS found

no basis for what form this time path for

benefits should take. However, FSIS wants to

account for any lag in the effectiveness of

producer actions and other factors that may

affect the immediate realization of full

benefits. FSIS uses the following time path

for realization of benefits: 5% realization by

the first year; 10%, by the second year; 15%,

by the third year; 40%, by the fourth year;

50%, by the fifth year; 60%, by the sixth

year; 70%, by the seventh year; 80%, by the

eighth year; 90%, by the ninth year; and,

100% by year ten. FSIS requests comment

and information regarding the realization of

projected benefits.

Benefits are predicated on a chain of

events: the proposed rule testing

requirements motivating establishments to

maintain higher sanitation standards; the

introduction of less contaminated product in

commercial channels; and eventually, fewer

listeriosis cases and deaths from the

consumption of RTE meat and poultry

products.

Mandatory environmental food contact

surface testing forces producers to incur costs

to recognize (and, if need be, to remedy) their

contamination problems. These costs, and

those related to performance standards, are

made up of mostly one-time, first-year costs

and low recurring annual costs. More than

half (56 percent) is related to performance

standards, not mandatory testing (44

percent). Still, FSIS expects that the benefits

derived from mandatory testing results

would exceed the costs of both provisions.

TABLE 13.—NOMINAL AND REAL COSTS OF THE PROPOSED RTE RULE AND ASSOCIATED LISTERIOSIS CASE REDUCTIONS

AT 100 PERCENT EFFECTIVENESS—ALL RTE MEAT AND POULTRY PRODUCTS

Year Nominal cost

($ million)

Real cost

($ million)

Cases eliminated

FDA–FSIS

draft risk

assessment

Mead-Olsen

studies

1 ..................................................................................................................... 12.6 11.8 83 8.35

2 ..................................................................................................................... 6.2 5.4 166 16.7

3 ..................................................................................................................... 6.2 5.0 249 25.05

4 ..................................................................................................................... 6.2 4.7 664 66.8

5 ..................................................................................................................... 6.2 4.4 830 83.5

6 ..................................................................................................................... 6.2 4.1 996 100.2

7 ..................................................................................................................... 6.2 3.8 1162 116.9

8 ..................................................................................................................... 6.2 3.6 1328 133.6

9 ..................................................................................................................... 6.2 3.3 1494 150.3

10 ................................................................................................................... 6.2 3.1 1160 167

Total ........................................................................................................ 68.1 49.3 8632 868.4

1The year-end discount rate used is 7.0 (OMB, Circular No. A–94, updated January 2000).

Alternatives

Executive Order 12866 requires that FSIS

identify and assess alternative forms of

regulation. FSIS considered one alternative to

all of the proposed regulations and five

alternatives to the proposed testing

requirements. These are discussed below.

1. No Action

The Agency considered not requiring the

proposed performance standards for RTE

meat and poultry products. Small and very

small establishments may incur most of the

costs of the proposed extension of the

existing performance standards to all RTE

meat and poultry products. There are

currently performance standards for certain

not-shelf-stable RTE meat and poultry

products (RTE roast beef, corned beef, all

‘‘fully-cooked’’ RTE poultry products, and

partially-cooked meat patty and poultry

products). However, there currently are no

performance standards specific to jerky, meat

hotdogs, and luncheon meat and the current

requirements for meat patties effect a

lethality less stringent than that which is

proposed.

FSIS considered not proposing to extend

the performance standards to these products

because of the possible disproportionate

economic impact on small business.

However, taking this alternative would result

in a significant inconsistency in the Agency’s

public health policy. Most, if not all, RTE

meat and poultry products are manufactured

from the same supply of raw product

examined in the FSIS national baseline

surveys. So, performance standards derived

from this baseline should be applicable to all

categories of RTE meat and poultry products,

regardless of how they are processed. All

RTE products should be required to meet the

same standard of safety. FSIS will publish

compliance guides and possibly take other

actions to mitigate the economic effects of

any final rule on small businesses.

In general, some members of the meat and

poultry industry believe that regulatory

performance standards are unnecessary or

redundant, considering that FSIS already

requires all meat and poultry establishments

to develop and implement HACCP systems.

FSIS believes, however, that developing

HACCP systems around verifiable, objective

performance standards is the most effective

way for establishments to consistently

produce safe, unadulterated meat and poultry

products. Furthermore, by proposing

performance standards for pathogens whose

destruction results in the destruction of most

or all other pathogens of concern, FSIS

provides a reference for establishments to use

in gauging the efficacy of their HACCP

systems. FSIS, therefore, is proposing

pathogen reduction performance standards

that can be incorporated into HACCP

systems, rather than requiring that

establishments rely upon HACCP alone.

FSIS considered not revising the

prescriptive canning and trichina treatment

requirements for certain pork products.

However, these provisions of the proposed

regulations represent regulatory reform and

streamlining efforts. The regulatory safety

standards for commercially sterile products

and for pork products would be unaffected

by this proposal. FSIS also considered not

requiring testing for Listeria. However,

without some regulatory requirements

addressing Listeria, many establishments will

continue not to regard L. monocytogenes as

a post-lethality hazard reasonably likely to

occur and not take steps through Sanitation

SOPs or HACCP to ensure the safety of their

products. FSIS tentatively concludes that

12634 Federal Register / Vol. 66, No. 39 / Tuesday, February 27, 2001 / Proposed Rules

without defining required actions in either

the Sanitation SOPs or HACCP, product will

continue to test positive for L.

monocytogenes and outbreaks will continue

to occur.

2. End-Product Testing

FSIS considered proposing to require

testing of finished product for L.

monocytogenes instead of the proposed food

contact surface testing for Listeria spp. In

short, FSIS does not believe that such endproduct testing at levels high enough to

ensure statistical confidence would be a

practical means of ensuring that RTE meat

and poultry products are not adulterated by

L. monocytogenes. To determine that every

lot of RTE product was not adulterated by L.

monocytogenes, an establishment would

likely have to test a significant portion of

each lot and hold each lot until test results

were confirmed.

Further, end-product testing to verify

process control is antithetical to the notion

of process control under the Agency’s

HACCP and Sanitation SOP regulations.

Granted, FSIS is proposing to require product

be held and tested in the event an

establishment has a positive food-contact

surface test result. But this proposed product

testing is a measure every prudent

establishment should take when it

determines that its Sanitation SOP is

ineffective and that product may have been

produced under insanitary conditions and

therefore may be adulterated. FSIS believes,

based on the numerous recalls involving

small quantities of RTE meat and poultry

products and the fact that the majority of the

recalls are initiated in small and very small

establishments, that members of the meat and

poultry product industry are not effectively

ensuring that products are not adulterated.

Thus, the Agency, in the interest of public

health, opted to propose making mandatory

food-contact surface testing for Listeria spp.

3. Mandatory Post-Lethality Interventions for

L. monocytogenes

FSIS is aware of several establishments

that currently apply a post-lethality steam

pasteurization treatment to their RTE

products, specifically to eliminate L.

monocytogenes. FSIS allowed establishments

to use antimicrobials specifically effective in

preventing growth of L. monocytogenes in

RTE products (i.e., sodium diacetate,

potassium lactate, and sodium lactate, 65 FR

17128, March 31, 2000). Furthermore, in the

future, other types of antimicrobial

interventions that can be applied after

lethality treatment and after packaging that

can eliminate L. monocytogenes from RTE

products may be available. For example,

eventually, FDA and FSIS may allow

establishments to treat RTE products with

ionizing radiation. If applied within a

HACCP system, irradiation could eliminate L.

monocytogenes from a RTE product. FSIS

also is aware that industry is developing

edible, antimicrobial coatings that could be

applied to RTE meat and poultry after

cooking or other lethality treatments.

However, FDA has not yet approved any of

these coatings for meat and poultry.

FSIS considered requiring establishments

to implement post-lethality antimicrobial

controls instead of testing food contact

surfaces for L. monocytogenes. Obviously,

however, since most of the needed

technologies are not yet available or not yet

approved, establishments would have a

limited number of treatments to choose from

and some may not be appropriate or useable

in every processing system. Further,

mandating the use of any specific technology

would be counter the Agency’s goal of

granting establishments maximum flexibility

to innovate and design customized processes

capable of producing safe meat and poultry

products. And, initially, many of these new

technologies may be prohibitively expensive

as they become available, especially for small

businesses.

By proposing to exempt establishment with

CCPs for L. monocytogenes from the required

testing, FSIS is providing an incentive for

establishments to implement these new

technologies as they become available. Also,

the proposed exemption will allow

establishments to conduct testing instead of

developing HACCP plan controls, if they find

testing to be a more cost-effective means of

preventing contamination of the their RTE

products by L. monocytogenes as result of

insanitation.

4. Mandatory Food Contact Surface Testing

for All Establishments That Produce RTE

Products

Because L. monocytogenes is an

environmental contaminant and often

adulterates RTE products as a result of

insanitation, FSIS considered requiring all

establishments that produce RTE meat and

poultry products to test for Listeria spp. as a

way to verify plant sanitation, regardless of

whether they have implemented HACCP

controls for L. monocytogenes. However, if an

establishment develops a new CCP or

designates an existing CCP to control

contamination of its products by L.

monocytogenes, it will be taking process

control actions that likely will include

sanitation practices to limit levels of L.

monocytogenes on incoming raw product,

lethality steps to destroy L. monocytogenes,

sanitation control steps to prevent

recontamination, or testing to validate and

then frequently verify that its controls are

effective. FSIS believes that requiring these

establishments to also conduct the

mandatory testing for Listeria spp. would be

unnecessary and redundant. Further,

requiring all establishments that produce

RTE products to conduct testing for Listeria

spp. is expected to increase annual

compliance costs from the estimated $1.75

million in testing costs related to the specific

provisions in the proposed rule to $4.6

million. Again, these costs should be

regarded as direct annual recurring costs

associated with the minimum number of food

contact surface testing estimated by FSIS.

5. Redesignation of Hotdogs and Other

Products as Not-Ready-To-Eat

FSIS considered creating a new category of

products for partially-cooked sausages and

other products that no longer would be

considered RTE. An establishment that

redesignated its meat and poultry product as

not RTE would not be required to conduct

the proposed testing for Listeria spp. nor

meet any other regulatory requirements

applicable only to RTE products. FSIS would

require the establishment, however, to label

its not RTE product with the safe handling

instruction (9 CFR 317.2(l), 381.125(b)) and

with cooking instructions similar to that for

partially-cooked meat patties and poultry

rolls (9 CFR 318.23 and 381.150).

The safe handling instruction is required

for all products that have not undergone

processing that would render them RTE and

includes four labeling statements, including

‘‘cook thoroughly’’ along with a graphic

illustration of a skillet. The cooking

instruction is currently required for partiallycooked meat patties and poultry rolls, which

need thorough cooking prior to consumption

for safety. This cooking instruction states:

‘‘Partially-cooked: For Safety Cook until Well

Done (Internal Meat Temperature of 160

degrees Fahrenheit)’.

FSIS considers cooked meats, including

those defined in 9 CFR 319.180 (Subpart G—

Cooked Sausage) which include frankfurters,

hotdogs, wieners, bologna, and similar

products, to be RTE products. Ready-to-eat

products should be safe to consume without

any additional cooking or application of a

lethality treatment by the consumer. More

importantly, it is likely that most consumers

also consider hotdogs and similar products to

be RTE, and only apply a heat treatment to

improve product palatability. Consumer

behavior would have to be significantly

modified to ensure that they are aware that

an adequate cook for safety must be applied

to these products.

Another consideration is that restaurants,

including street vendors and quick-service

operations, would have to treat these

redesignated products as not-RTE. The

current Model Food Code provides that RTE

food taken from a commercially-processed

intact package from a food processing plant

shall be heated to a temperature of at least

140 degrees Fahrenheit for hot holding (FDA

Food Code, section 3–403.11). The hot

holding temperature is not intended to serve

as the lethality treatment for the product, but

only as a temperature sufficient to prevent

multiplication of pathogens while the

product is being held prior to sale. Thus, this

industry would have to apply a higher

minimum temperature and time combination

to achieve the necessary lethality for safety.

FSIS does not have the data needed to

estimate the costs that would result from the

redesignation of certain hotdogs and similar

products as not-RTE. Direct costs to industry

would include: new labeling; the cost to

retailers who be required to apply higher

time/temperature combinations to the

redesignated products; and possible loss of

market share by firms that redesignate their

products as not-RTE to firms that continue to

produce RTE products. Other costs include

consumer education and, most importantly,

possible public heath costs resulting from

consumers inadequately cooking not-RTE

products traditionally considered RTE and

consequently contracting foodborne illnesses.

It is likely that these costs would exceed the

savings that industry would accrue from

being exempted from the proposed testing

requirements and other requirements

Federal Register / Vol. 66, No. 39 / Tuesday, February 27, 2001 / Proposed Rules 12635

30Up to 92 percent of all listeriosis cases and

deaths from RTE meat and poultry products, as

calculated by FDA–FSIS RA, was attributable to the

consumption of deli meats and frankfurters.

applicable to RTE products and FSIS has

therefore rejected this alternative. FSIS does

request comment, however, on these and

related issues.

6. Require ‘‘Use-By’’ Date Labels on Certain

RTE Meat and Poultry Products

FSIS considered, but is not proposing,

requiring that the labeling of certain RTE

meat and poultry products state the product’s

shelf-life, and that shelf-life be based on

product safety (‘‘use-by’’ date labeling) in

addition to the proposed L. monocytogenes

control measures. L. monocytogenes

contamination is often a result of product

manipulation, such as the slicing of deli

meats or the peeling of hotdogs, after

lethality treatments are applied. In the recent

interagency draft risk assessment, FDA and

FSIS have concluded that numerous RTE

meat and poultry products that undergo postlethality manipulation and that can support

the growth of L. monocytogenes in their final

packaging and under refrigerated conditions

are at relatively higher risk of causing

listeriosis.

Food contact surface testing does not

address (1) the physical inability of current

testing devices to detect minuscule amounts

of L. monocytogenes in some finished RTE

meat and poultry products after their

manufacture and (2) the capability of L.

monocytogenes to grow-out in certain

products, even while being kept under

refrigerated temperatures. Thus, process

controls and food contact surface testing may

not reduce risk sufficiently. Some small

amounts of product, with non-detectable L.

monocytogenes contamination levels, could

continue to enter commercial food channels.

Also, consumers may be improperly handling

certain products. The main meat and poultry

products of concern are deli meats and

frankfurters—products which receive postprocessing handling and manipulation and

have been associated with past listeriosis

outbreaks.30 If consumers understood ‘‘useby’’ dates and changed their behavior

accordingly, ‘‘use-by’’ labels could help to

ensure food safety through proper handling

of RTE meat and poultry products and

thereby reduce the risk of listeriosis.

However, it is likely that consumer behavior

would have to be significantly modified to

ensure that they are understand ‘‘use-by’’

dating.

For most consumers who are healthy and

safely handle their food, this low level of

possible L. monocytogenes contamination

does not pose a significant food safety

hazard. However, this is not the case for

high-risk individuals who may be severely

harmed by L. monocytogenes, even by

slightly contaminated RTE meat and poultry

products. Increased mandatory food contact

surface testing should reduce the likelihood

of any L. monocytogenes contamination

present in these products.

In the process, producers and marketers

will likely alter their behavior with respect

to product rotation in storage and marketing.

There is sparse information regarding the

potential affects of this labeling, the

likelihood that consumer practices will

change, and on the effect of changes in

consumer behavior on listeriosis cases.

Similarly, FSIS currently does not possess all

the information necessary to assess the

reduction in risk that will occur from this

change. Also, the ‘‘use-by’’ date labeling may

give consumers a false sense of security.

Much uncertainty surrounds the potential

costs and benefits of ‘‘use-by’’ dating. Little

research has been done to address many

issues regarding this alternative. For

instance, what is the likely consumer

reaction to ‘‘use-by’’ date labeling? What are

the public health consequences? How would

‘‘use-by’’ date labeling potentially impact the

production and shipment patterns of labeled

RTE meat and poultry products and the

structure of the industry? For example, will

smaller operations benefit from a ‘‘use-by’’

date more than larger operations who must

rely on larger sales areas which require

longer product shelf life to penetrate the

entire marketing area?

Further, much uncertainty surrounds

expectations for increased consumer

awareness by the high-risk sub-population of

‘‘use-by’’ date labeling. Assuming the

awareness rates for the high-risk subpopulation were the same as the general

population, only 12.4 fewer annual listeriosis

deaths would result from ‘‘use-by’’ dating (as

opposed to 54).

Comment Request

FSIS requests comment on the feasibility of

requiring ‘‘use-by’’ date labeling on certain

RTE meat and poultry products, generally in

regard to the public health benefits and the

costs of such labeling, and specifically in

regard to the following questions:

(1) What would be the most effective way

to implement an ‘‘use-by’’ labeling scheme?

Should FSIS propose to require that use-by

dates be determined and validated within the

producing establishment’s HACCP plan? Or,

should another alternative be used.

(2) What assumptions should be used

about retailer and consumer behavior in

determining a use-by date? Should the useby date be determined under the assumption

that retailers and consumers will follow any

handling instructions contained in the

labeling? Or, should the use-by date

determination be based on a ‘‘worst case’’

assumption that products will be mishandled

or temperature abused?

(3) What scientific and economic data are

available regarding the shelf-life and safety of

RTE meat and poultry products contaminated

with L. monocytogenes? Are any studies of

‘‘use-by’’ date labeling efficacy available?

FSIS is currently working with the

Agricultural Research Service on a study to

evaluate the shelf-life of hotdogs and is aware

of other studies, but welcomes any additional

information. FSIS would publish guidance

regarding use-by dating before any final

action becomes effective and would base this

guidance on the latest science available.

(4) Should FSIS propose to require postlethality L. monocytogenes interventions

instead of ‘‘use-by’’ date labeling? FSIS is

aware that in the future, certain types of

antimicrobial interventions that can be

applied after lethality treatment but before

packaging and that can eliminate L.

monocytogenes from RTE products may be

available. Eventually, FDA and FSIS may

allow establishments to treat RTE products

with ionizing radiation. If applied within a

HACCP system, irradiation could eliminate L.

monocytogenes from a RTE product. FSIS

also is aware that industry is developing

edible, antimicrobial coatings that could be

applied to RTE meat and poultry after

cooking or other lethality treatments.

However, FDA has not yet approved any of

these coatings for meat and poultry.

(5) What language would be most effective

in informing consumers about ‘‘use-by’’ date

labels? Would labeling such as ‘‘For safety,

use-by * * *’’ be more effective? Should the

labeling indicate anything regarding

vulnerable populations? Should FSIS

propose to allow for a variety of phrases?

FSIS is aware that many RTE meat and

poultry products already carry shelf-life

labeling indicative of product quality. Would

allowing different phrases result in consumer

confusion? Would allowing quality and

safety dates to appear on the same package

result in confusion? Should FSIS propose to

allow different dates based on handling

instructions, for instance: one date if the

consumer freezes the product, another if the

consumer refrigerates the product?

Uncertainty

Benefits Side

The current level of benefits does not

consider what technical obstacles exist that

may reduce the effectiveness of the

provisions in the proposed rule to actually

reduce listeriosis cases and deaths. FSIS is

uncertain about the effectiveness of its

proposed testing requirements in reducing

listeriosis, and therefore unable to adequately

quantify a range of benefits. No research that

directly looked into this subject was found in

the literature. FSIS intends to use comments

and data received during the comment period

and at the planned technical conference to

refine the proposed regulations and to better

estimate benefits. It is of course unlikely that

the proposed regulations could achieve

complete elimination of the listeriosis that

results from contaminated meat and poultry,

but FSIS believes that the benefits of the

regulations would exceed the total costs of all

of the proposed provisions. The current

baseline analysis does not consider any

private sector benefits that may result from

the proposed rule. The impact of fewer

recalls, possibly smaller amounts of returned

product with better labeling, fewer consumer

complaints, and other reduced costs may

benefit the establishments that thrive in the

new regulatory environment.

The benefits in this analysis are calculated

as if they accrue gradually over time. More

research into this subject is needed. Although

some research has shown that it would take

six to eighteen months for industry LMcontrol efforts to show positive results, little

research was found that looked into the time

path for benefits.

Unquantified Benefits Resulting From

Proposed Performance Standards

There are currently no performance

standards specific to jerky, meat hotdogs, and

12636 Federal Register / Vol. 66, No. 39 / Tuesday, February 27, 2001 / Proposed Rules

luncheon meat and the current requirements

for meat patties effect a lethality less

stringent than that which is proposed.

Fermented sausage makers were advised in

the mid-1990’s on methods to ensure food

safety and most of these processors made

changes to their production at that time;

however, this is not known for sure. As such,

processors of meat patties and the dried,

fermented, and salt-cured RTE meat and

poultry products are expected to feel the

major impact from the proposed rule.

However, little is known about the

production process for many dried and

fermented products affected by this rule.

According to one study, E. coli O157:H7

causes 52 foodborne-related deaths per year.

Nontyphoidal Salmonella causes 582

foodborne-related deaths per year (Mead,

1999). Some benefits are expected to be

generated by fewer sicknesses due to the

proposed Salmonella and E. coli O157:H7

performance standards that would be

extended to certain RTE meat and poultry

products that are not currently required to

meet these performance standards. However,

FSIS has not conducted a quantitative

analysis of these benefits and requests

comments and data on possible benefits

resulting from the proposed requirements.

FSIS is replacing prescriptive provisions

concerning thermally processed,

commercially sterile meat and poultry

products with performance standards. The

proposed performance standards will ensure

that this product continues to be safe. FSIS

believes these proposed provisions would

not impose any costs because producers

could continue to follow the same

procedures required under the current

regulations. Producers may realize some

benefit from the flexibility that will be

allowed under the performance standard

regulations if they adopt new innovative

means of producing the product. However,

FSIS could not estimate any benefits that

may be derived from replacing these

prescriptive provisions with performance

standards and requests comment on possible

benefits that may be realized.

FSIS is proposing to eliminate its

regulations that require both RTE and notready-to-eat pork and products containing

pork be treated to destroy trichinae

(Trichinella spiralis). FSIS believes that, even

if these provisions are removed, pork

products will continue to be safe from

trichinae. For heat-treated, RTE products

containing pork, the required treatment to

destroy trichinae would no longer be needed

because if the process used meets the

proposed performance standards for

Salmonella, the process should eliminate any

live trichinae. For other products, if the

establishment identifies trichina as a hazard

reasonably likely to occur, the establishment

would have to ensure that the process used

effectively eliminates this hazard. If the

prescriptive provisions concerning trichinae

are removed from the regulations, producers

may realize benefits if they determine

trichina is not a hazard reasonably likely to

occur or if they find new ways of treating

their product for trichinae.

Cost Side

Over eighteen percent of the first 10 years’

total cost of the proposed rule occurs in the

first year of program implementation. These

costs take the form of one-time outlays

related to validation of (1) modifications to

HACCP plans and (2) attainment of

performance standards. FSIS anticipates that

expected industry costs resulting from this

proposed rule could be lowered substantially

with assistance to deal with these one-time

costs.

There may be some consumer welfare

losses that result from lower production that

may result from this proposed rule. Because

some firms may lose market share for their

RTE meat and poultry products, consumers

may be provided with fewer RTE meat and

poultry products in total and a more limited

choice among RTE meat and poultry

products. Comments are welcome concerning

the extent to which this proposed rule may

affect the range of RTE meat and poultry

products and other issues dealing with

consumer choice.

The analysis of the costs associated with

performance standards noted that the cost

estimate used is highly uncertain, being

based on information gathered in a pilot

survey. An industry survey is underway and

hopefully will address much of the

uncertainty of production processes currently

employed by producers of these products and

their options when faced with higher

performance standards. FSIS based the

analysis on performance standards on very

limited data, much of it received as part of

a pilot survey. FSIS requests information

concerning the production process for many

of these dried and fermented products

affected and the options that producers have

in dealing with this provision.

Much uncertainty involves the break down

of these results by size of establishment. As

noted in this analysis and the Regulatory

Flexibility Act section, an argument can be

made that the proposed rule will

disproportionately affect small entities.

However, to the extent that validation costs

(which can be considered more like fixed

costs rather than variable costs) can be

reduced, this effect will be minimized.

Without these reductions, however,

validation costs would tend to

disproportionately affect small producers

rather than large ones. Any research and

assistance to make these needed validations

and production adjustments as scale-neutral

as possible could dampen the possible

disproportionate impact on small entities.

Mandatory food contact surface testing

could impose a need to build additional

storage for suspected contaminated products

to wait in a ‘‘test and hold’’ period. This may

affect smaller operations more than larger

ones. FSIS requests comments that address

this issue.

[FR Doc. 01–4420 Filed 2–26–01; 8:45 am]

BILLING CODE 3410–DM–P