[Federal Register: May 26, 1999 (Volume 64, Number 101)]

[Rules and Regulations]               

[Page 28351-28353]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]




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 



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: 


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.


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

[[Page 28352]]

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 


    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 


    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.

[[Page 28353]]

    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 


    (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,


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