[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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