Listeria Monocytogenes Contamination of Ready-to-Eat Products

DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Parts 416 and 417

[Docket No. 99-025N]

Listeria Monocytogenes Contamination of Ready-to-Eat Products

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Compliance with the HACCP system regulations and request for

comment.

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SUMMARY: The Food Safety and Inspection Service (FSIS) is publishing

this document to inform manufacturers of ready-to-eat livestock and

poultry products of the Agency's views about the application of the

hazard analysis and critical control point (HACCP) system regulations

to contamination with Listeria monocytogenes.

FSIS believes that the findings from testing a range of ready-to-

eat products and information from investigations of outbreaks of

listeriosis constitute changes that could affect an establishment's

hazard analysis or alter the HACCP plan for affected products.

Therefore, establishments must reassess their HACCP plans for ready-to-

eat livestock and poultry products. If reassessment results in a

determination that Listeria monocytogenes contamination is a food

safety hazard reasonably likely to occur in the establishment's

production process, then it is a type of microbiological contamination

that must be addressed in a HACCP plan.

In this document, FSIS is setting out several factors that it

believes an establishment should consider when performing its

reassessment. Also, FSIS is making guidance material available that

establishments may find helpful. (See ADDRESSES). FSIS invites comments

on the factors addressed in this document and on its guidance material.

DATES: Comments may be submitted by July 26, 1999.

ADDRESSES: Submit one original and two copies of written comments to

FSIS Docket Clerk, Docket No. 99-025N, U.S. Department of Agriculture,

Food Safety and Inspection Service, Room 102, Cotton Annex, 300 12th

Street, SW, Washington, DC 20250-3700. All comments submitted in

response to this document 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.

Guidance material is available from the Inspection Systems

Development Division, FSIS, USDA, Room 202, Cotton Annex Building, 300

12th Street SW, Washington, DC 20250-3700, phone (202) 720-3219, Fax

(202) 690-0824. The material is also available on the FSIS Homepage:

http://www.fsis.usda.gov/index.htm

FOR FURTHER INFORMATION CONTACT: Daniel L. Engeljohn, Ph.D., Director,

Regulations Development and Analysis Division, Food Safety and

Inspection Service, Washington, DC 20250-3700; (202) 720-5627.

SUPPLEMENTARY INFORMATION:

Regulatory Context

The Food Safety and Inspection Service (FSIS) administers the

regulatory program 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.) to protect the health and welfare of consumers by

preventing the distribution of livestock and poultry products that are

unwholesome, adulterated, or misbranded. To further the goal of

reducing the risk of foodborne illness from livestock and poultry

products to the maximum extent possible, FSIS issued the Pathogen

Reduction-Hazard Analysis and Critical Control Point (HACCP) Systems

final rule on July 25, 1996 (61 FR 38806). These regulations require

federally inspected establishments to take preventive and corrective

measures at each stage of the food production process where food safety

hazards occur.

Part 416, the regulations on Sanitation Standard Operating

Procedures (SOP's), requires establishments to develop, implement, and

maintain written SOP's for sanitation that describe daily procedures

that are sufficient to prevent direct contamination or adulteration of

products (Sec. 416.11 and 416.12(a)). Part 417, the regulations on

HACCP systems, requires a hazard analysis to determine the food safety

hazards reasonably likely to occur in the production process and

identify the preventive measures an establishment can apply to control

those hazards in the production of particular products (Sec. 417.2(a)).

Whenever a hazard analysis reveals one or more such hazards, the

regulations require the establishment to develop and implement a

written HACCP plan, for each product, that includes specified controls

for each hazard so identified (Sec. 417.2(b)(1) and (c)).

When FSIS issued the Pathogen Reduction-HACCP Systems final rule,

it responded to questions about the link between Sanitation SOP's and

HACCP plans by noting the importance of Sanitation SOP's as tools for

meeting existing sanitation responsibilities and preventing direct

product contamination and adulteration and their appropriateness as

near-term procedures--that is, for implementation prior to HACCP

implementation and, in a sense, as a prerequisite to HACCP. In response

to concerns about redundancy, the Agency noted that a sanitation

procedure incorporated into a validated HACCP plan need not be

duplicated in the establishment's Sanitation SOP's. FSIS also

anticipated that some Sanitation SOP procedures, such as those

addressing pre-operational cleaning of facilities, equipment, and

utensils were likely to remain in an establishment's Sanitation SOP's.

(61 FR 38834.)

The HACCP system regulations require an official establishment to

develop and implement a written HACCP plan whenever a hazard analysis

reveals one or more food safety hazards that are reasonably likely to

occur in the production process ((Sec. 417.2(a), (b)(1), and (c)).

Paragraph (a)(1) of Sec. 417.2 specifies the purpose of a hazard

analysis: ``to determine the food safety hazards reasonably likely to

occur in the production process and identify the preventive measures

the establishment can apply to control those hazards.'' Ten potential

hazard areas, including microbiological contamination, are listed to

guide establishments in this analysis (Sec. 417.2(a)(3)).

Section 417.2(a)(1) also provides that a food safety hazard is

reasonably likely to occur if a prudent establishment would establish

controls because the hazard historically has occurred, or because there

is a reasonable possibility that it will occur in the particular type

of product being processed, in the absence of those controls.

The likelihood that a potential food safety hazard will occur in

the production process for a particular

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product at a given location, and the identification and adequacy of

preventive measures to control a likely hazard, must be determined by

each establishment. Obviously, conditions may well change over time.

For this reason, the HACCP system regulations require every

establishment to reassess HACCP plan adequacy at least annually and

whenever any changes occur that could affect the underlying hazard

analysis or alter the HACCP plan (Sec. 417.4(a)(3)). When reassessment

reveals that a plan no longer meets the requirements for the contents

of a HACCP plan, the establishment must modify the plan immediately

(Sec. 417.4(a)(3)).

Listeria Monocytogenes

Listeria monocytogenes is a type of pathogenic bacteria often found

in the intestines of healthy animals (including humans) and in the

environments in which food producing animals are raised and processed

(e.g., in soil, water, and vegetation and on the surfaces of equipment,

floors, and walls). Therefore, food may be contaminated with this

microorganism and, after cooking or other treatment to destroy the

pathogen, may be recontaminated.

Listeria monocytogenes can cause listeriosis, a serious and

sometimes fatal illness, for which pregnant women, newborns, the

elderly, and people with weakened immune systems are at risk. The most

common manifestation of listeriosis is meningitis. It also can cause

miscarriages and stillbirths. Advances in molecular subtyping methods

have improved scientists' ability to associate Listeria monocytogenes

with particular products and to detect outbreaks of listeriosis.

Since the late 1980's, FSIS and the Food and Drug Administration

(FDA) have worked with food manufacturers to improve procedures for

ensuring that ready-to-eat foods (i.e., products that may be consumed

without any further cooking or other preparation) are free of Listeria

monocytogenes. In addition, for the past decade, FSIS has conducted a

microbiological testing program in which the Agency samples ready-to-

eat livestock and poultry products, including cooked and fermented

sausages, cooked corned beef, sliced ham and luncheon meats, beef

jerky, cooked uncured poultry, and salads and spreads, in federally

inspected establishments. (For the Agency's current testing program

instructions, see FSIS Directive 10,240.2, Microbial Sampling of Ready-

to-Eat Products Produced by Establishments Operating Under a HACCP

System.) FSIS treats ready-to-eat products in which Listeria

monocytogenes is found as adulterated under the FMIA or the PPIA (21

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

Between 1989 and 1993, the rate of illness from Listeria

monocytogenes declined. Over the next several years, there did not

appear to be any further decline, however, and since last fall, there

has been an increase in the number of cases caused by a specific

subtype--a previously rare ``E'' pattern--of Listeria monocytogenes.

The Centers for Disease Control, U.S. Public Health Service, Department

of Health and Human Services (DHHS), have reported 101 illnesses, 15

adult deaths and 6 stillbirths or miscarriages associated with this

``E'' pattern. Using methodological advances that provide more specific

information about pathogens isolated from foods and humans, public

health agencies have obtained information associating the ``E'' pattern

subtype of Listeria monocytogenes with livestock and poultry products.

FSIS currently is evaluating a range of measures, both short- and

long-term, to improve public health protection against this pathogen.

In aid of this evaluation, FSIS held a public meeting on February 10,

1999, at which research, regulation, and education activities along

with industry and government procedures, were discussed.

Controlling Listeria Monocytogenes Contamination

FSIS is publishing this document to advise federally inspected

establishments of the Agency's current position on one aspect of the

public health strategy to deal with Listeria monocytogenes

contamination and to provide an opportunity to comment on that position

as FSIS continues to develop a comprehensive strategy. FSIS is

concerned because some establishments have not reassessed their HACCP

plans after recent outbreaks of listeriosis caused by contaminated

ready-to-eat livestock and poultry products, and after some

establishments have produced ready-to-eat products adulterated with

Listeria monocytogenes. If Listeria monocytogenes contamination is a

food safety hazard reasonably likely to occur in an establishment's

production process, then it must be addressed in a HACCP plan. It would

not be sufficient to claim that the hazard is adequately dealt with in

the establishment's Sanitation SOP. HACCP plan reassessment is

necessary to determine whether the plan appropriately addresses this

hazard.

FSIS views investigations of recent outbreaks of listeriosis and

findings of Listeria monocytogenes contamination, along with other

information now available on the prevalence and persistence of this

foodborne pathogen, as sufficient evidence that some establishments'

present approach to the food safety hazard presented by ready-to-eat

livestock food and poultry products adulterated with Listeria

monocytogenes does not comply with part 417 requirements. Therefore,

FSIS believes that Sec. 417.4(a)(3) requires that establishments

reassess the HACCP plans that cover ready-to-eat livestock and poultry

products.

Put another way, the Agency does not see how--given the current

record of contamination incidents and information now available on the

prevalence and persistence of the microorganism, its ability to survive

under adverse conditions, and the apparent susceptibility of some

products to contamination--an establishment that produces a ready-to-

eat product (other than one that is thermally processed-commercially

sterile, in accordance with part 318, subpart G, or part 381, subpart

X, of the regulations) could have confidence that, in operation, the

HACCP plan for the product meets part 417 requirements.

FSIS' conclusion addresses only the need for HACCP plan

reassessment. FSIS cannot predict the likelihood that an establishment

producing ready-to-eat products would be required under the regulations

to incorporate, or alter, controls to prevent Listeria monocytogenes

contamination in one or more HACCP plans as a result of plan

reassessment. FSIS does believe, however, that given current knowledge,

Listeria monocytogenes contamination should be considered to be

reasonably likely to occur in the production of ready-to-eat livestock

and poultry products, especially if an establishment has produced

products adulterated with Listeria monocytogenes, or if the

establishment is producing one or more ready-to-eat products that are

susceptible to Listeria monocytogenes contamination in an environment

that is not known to be free of this pathogen.

FSIS urges establishments that produce ready-to-eat livestock and

poultry products to perform the reassessment of their HACCP plans

within 30 days of the publication of this document. FSIS will instruct

its inspection personnel to verify that reassessments were conducted.

If an establishment does not reassess its HACCP plan in accord with

this document, FSIS will evaluate the establishment's compliance with

Part 417.

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Set out below are factors that FSIS believes are relevant in

determining whether Listeria monocytogenes contamination is a food

safety hazard reasonably likely to occur in the production process and

in identifying preventive measures that establishments can apply to

control the hazard. Reassessments of HACCP plans should take these

factors into account. FSIS is providing technical information and other

Agency guidance material. (See ADDRESSES to obtain copies.) The Agency

invites comments on this guidance material and the factors set out

below.

(1) Pathogen Levels in Starting Materials FSIS believes that it is

crucial that each establishment know the characteristics of its

starting materials and, in particular, keep itself informed about

evidence of Listeria monocytogenes contamination of the raw materials

or source of raw materials that the establishments use.

(2) Validation of Lethality Treatment FSIS believes industry

members must comply rigorously with the HACCP plan validation

requirements of Sec. 417.4(a)(1), especially in ensuring that the

establishment can successfully apply a scientifically appropriate

lethality treatment under its commercial operating conditions (see 61

FR 38826-38827). Until the establishment demonstrates that it achieves

the anticipated lethality effect under actual in-plant conditions,

effectiveness is theoretical, and the plan is not validated.

(3) Exposure to Contamination After Lethality Treatment The

available evidence on the presence of Listeria monocytogenes in food

processing environments appears to indicate an increased potential for

the contamination of product after a food is processed to destroy

pathogenic microorganisms. Therefore, an establishment's reassessment

of its HACCP plans needs to address such potential contamination.

Establishments should account for finished product characteristics such

as water activity, pH, and the presence or absence of one or more

barriers that inhibit pathogen growth. The HACCP plan must incorporate

any hazards identified by the reassessment.

(4) Evidence of Product Contamination FSIS believes that any

finding of Listeria monocytogenes in an establishment's ready-to-eat

product, whether in government or industry test results, is

substantial, and perhaps conclusive, evidence that Listeria

monocytogenes contamination is a food safety hazard that is reasonably

likely to occur in its production process for that product. Therefore,

in the event of such a finding, FSIS' position is as follows. If the

establishment's HACCP plan does not already provide for the control of

Listeria monocytogenes, and absent substantial, scientifically

supportable reasons, that HACCP plan must be modified to address the

Listeria monocytogenes hazard and incorporate appropriate controls. If

the establishment's HACCP plan does address and control for Listeria

monocytogenes, the establishment must take the appropriate corrective

actions in accord with the requirements of 9 CFR 417.3. FSIS inspection

personnel will verify that the establishment has taken the necessary

corrective actions.

Done at Washington, DC, on May 19, 1999.

Thomas J. Billy,

Administrator.

[FR Doc. 99-13223 Filed 5-25-99; 8:45 am]

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