[Federal Register Volume 63, Number 20 (Friday, January 30, 1998)]
[Rules and Regulations]
[Pages 4560-4562]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-2297]


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DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Part 417

[Docket No. 97-082N]


Contents of HACCP Plans; Critical Control Points

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Compliance with the HACCP system regulations.

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SUMMARY: The Food Safety and Inspection Service (FSIS) is publishing 
this document to ensure that the owners and operators of federally 
inspected establishments are aware that the identification of 
appropriate critical

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control points is crucial to complying with the Agency's regulations on 
hazard analysis and critical control point (HACCP) systems. The HACCP 
system regulations require that a HACCP plan list critical control 
points for each food safety hazard identified as reasonably likely to 
occur in the production process. The number of critical control points 
will depend upon the production process and the hazard, but a HACCP 
plan must specify as critical control points the points, steps, or 
procedures at which control can be applied and, as measured by critical 
limits, occurrence of the hazard can be prevented, eliminated, or 
reduced to an acceptable level, and at a minimum, the critical limits 
must be designed to ensure that applicable targets or performance 
standards established by FSIS, and any other requirement in the 
Agency's regulations pertaining to the specific process or product, are 
met. These requirements implement FSIS's judgment that whenever a food 
safety hazard is reasonably likely to occur in the production process, 
by applying control measures, the establishment can at least reduce the 
hazard to an acceptable level, even if it cannot entirely prevent or 
eliminate its occurrence.

FOR FURTHER INFORMATION CONTACT: Patricia F. Stolfa, Assistant Deputy 
Administrator, Regulations and Inspection Methods, Food Safety and 
Inspection Service, Washington, DC 20250-3700; (202) 205-0699.

SUPPLEMENTARY INFORMATION: The Food Safety and Inspection Service 
(FSIS) administers a 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 
products and poultry products that are unwholesome, adulterated, or 
misbranded. To further the goal of reducing the risk of foodborne 
illness from meat and poultry products to the maximum extent possible, 
FSIS issued the Pathogen Reduction-Hazard Analysis and Critical Control 
Point (HACCP) Systems final rule (61 FR 38806, July 25, 1996).
    The HACCP system regulations, part 417,1 require that 
every federally inspected establishment conduct, or have conducted for 
it, 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 
(Sec. 417.2(a)). Whenever a hazard analysis reveals one or more food 
safety hazards that are reasonably likely to occur, the establishment 
must develop and implement a HACCP plan, or plans, to control those 
hazards (Sec. 417.2(b)). Although it is possible that a hazard analysis 
conducted in accordance with the regulations will reveal no food safety 
hazard that is reasonably likely to occur, as the Agency stated when it 
issued the regulations, FSIS is not aware of any meat or poultry 
production process that can be deemed, categorically, to pose no likely 
hazards (61 FR 38824).2
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    \1\ Part 417 requirements will apply as of January 26, 1998, in 
establishments with 500 or more employees; January 25, 1999, in 
establishments with 10 or more but fewer than 500 employees (unless 
the establishment has annual sales of less than $2.5 million); and 
January 25, 2000, in establishments with fewer than 10 employees or 
annual sales of less than $2.5 million.
    \2\ Food safety hazards include any biological, chemical, or 
physical property that may cause a food to be unsafe for human 
consumption (Sec. 417.1).
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    For purposes of part 417, a critical control point (CCP) is a 
point, step, or procedure in a food process at which control can be 
applied and, as a result, a food safety hazard can be prevented, 
eliminated, or reduced to acceptable levels (Sec. 417.1).) Every HACCP 
plan must ``list the critical control points for each of the identified 
food safety hazards, including, as appropriate:''

    (i) Critical control points designed to control food safety 
hazards that could be introduced in the establishment, and
    (ii) Critical control points designed to control food safety 
hazards introduced outside the establishment, including food safety 
hazards that occur before, during, and after entry into the 
establishment * * *

(Sec. 417.2(c)(2)). The plan also must comply with the related 
requirements to specify the critical limits (maximum and minimum 
values) to be met at CCP's, the corrective actions to be followed in 
response to deviations from critical limits at CCP's, and the 
monitoring and verification procedures to ensure appropriate corrective 
actions if and when those deviations occur (Secs. 417.1, 417.2(c), 
417.3(a), and 417.4(a)). At a minimum, critical limits must be designed 
to ensure that applicable targets or performance standards established 
by FSIS, and any other requirement in FSIS's regulations (9 CFR chapter 
III) pertaining to the specific process or product, are met 
(Sec. 417.2(c)(3)).
    It has come to FSIS's attention that in developing HACCP plans, 
some persons are viewing CCP's so narrowly that they risk noncompliance 
with regulatory requirements. FSIS is concerned that some 
establishments may be relying solely on HACCP concepts and theory, 
without evaluating CCP's in accordance with regulatory requirements. 
The Agency is publishing this notice to ensure that the owners and 
operators of federally inspected establishments are aware that the 
identification of appropriate critical control points is crucial.
    The number of critical control points will depend upon the 
production process and the hazard. FSIS will treat failure to specify 
at least one CCP for each food safety hazard identified in accordance 
with the regulations as reasonably likely to occur as a failure to 
develop and implement a HACCP plan that complies with Sec. 417.2 
(Sec. 417.2(e)). The only exception, as specified in Sec. 417.2(b)(3), 
is for food safety hazards associated with microbiological 
contamination: HACCP plans that cover thermally processed/commercially 
sterile products produced in accordance with the current canning 
regulations (part 318, subpart G, or part 381, subpart X) need not, at 
this time, address microbial hazards.3
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    \3\ FSIS intends to convert the canning regulations to 
performance standards, which are more consistent with HACCP (61 FR 
38824).
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    FSIS anticipates that to operate in accordance with part 417, many 
establishments will find that for each identified hazard, they need 
more than one CCP, particularly if they are producing raw products. The 
Agency believes that depending upon a single CCP increases 
establishment exposure to production-disrupting corrective actions that 
affect large amounts of product. While FSIS is not prepared to say that 
compliance cannot be achieved with a single CCP when, for example, a 
product is treated sufficiently to be shelf stable, even though it is 
not commercially sterile, the Agency is concerned that establishments 
may be viewing CCP's too restrictively to ensure compliance with the 
regulations.
    The part 417 requirements addressed in this notice implement the 
Agency's conclusion that whenever a food safety hazard is reasonably 
likely to occur in the production process, even if an establishment 
cannot entirely prevent or eliminate occurrence of the hazard, by 
applying control measures, the establishment can at least reduce it to 
an acceptable level. Part 417 requires all federally inspected 
establishments to take the prudent, preventive approach and develop 
systematic measures for controlling such hazards.


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    Done at Washington, DC, on: January 26, 1998.
Thomas J. Billy,
Administrator.
[FR Doc. 98-2297 Filed 1-29-98; 8:45 am]
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