[Federal Register Volume 64, Number 101 (Wednesday, May 26, 1999)]
[Rules and Regulations]
[Pages 28351-28353]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-13223]


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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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