[Federal Register Volume 63, Number 20 (Friday, January 30, 1998)]
[Rules and Regulations]
[Page 4562]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-2296]


-----------------------------------------------------------------------

DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Part 417

[Docket No. 97-074N]


Contents of HACCP Plans

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Compliance with the HACCP system regulations.

-----------------------------------------------------------------------

SUMMARY: The Food Safety and Inspection Service is publishing this 
document to ensure that the owners and operators of federally inspected 
establishments are aware that its hazard analysis and critical control 
point (HACCP) system regulations require that an HACCP plan be a self-
contained document. In particular, the Agency does not view references 
to good manufacturing practices, or establishment actions in accordance 
with good manufacturing practices, as satisfying the requirements for 
the contents of an HACCP plan. Among other things, an HACCP plan must 
list the critical control points for each food safety hazard reasonably 
likely to occur in the production process, the critical limits that 
must be met at each of the critical control points, and the procedures, 
and frequency with which they will be performed, that will be used to 
monitor each critical control point to ensure compliance with critical 
limits and to verify that the plan is being effectively implemented. An 
HACCP plan also must identify the corrective actions to be followed in 
response to deviations from critical limits at critical control points.

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). As 
amended by that rule, FSIS's regulations require federally inspected 
establishments to take preventive and corrective measures at each stage 
of the food production process where food safety hazards occur.
    The regulations on HACCP systems, part 417,* require 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 them (Sec. 417.2(a)(1)) and, 
whenever this analysis reveals one or more such hazards, development 
and implementation of a written HACCP plan (Sec. 417.2(b)(1)). In 
Sec. 417.2(c), the regulations specify minimum requirements for the 
contents of each HACCP plan, including requirements to list the food 
safety hazards for each process; list the critical control points for 
each of the identified hazards; list the critical limits that must be 
met at each of the critical control points; list the procedures, and 
frequency with which they will be performed, that will be used to 
monitor each of the critical control points to ensure compliance with 
the critical limits; and list the verification procedures, and the 
frequency with which they will be performed, that the establishment 
will use in accordance with Sec. 417.4 (i.e., to verify that the plan 
is being effectively implemented) (paragraphs (c)(1), (c)(2), (c)(3), 
(c)(4), and (c)(7) of Sec. 417.2). In addition, a HACCP plan must 
include all corrective actions that have been developed in accordance 
with Sec. 417.3(a), which requires the identification of the corrective 
action to be followed in response to a deviation from a critical limit 
(Sec. 417.2(c)(5)).
---------------------------------------------------------------------------

    * 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.
---------------------------------------------------------------------------

    Given the explicit requirements to list critical control points, 
critical limits, and monitoring and verification procedures and to 
develop and identify corrective actions, and the Agency's statement, in 
issuing part 417, that it was clarifying requirements for the 
identification of critical control points within a HACCP plan (61 FR 
38825), FSIS is concerned that some industry members and consultants to 
industry think that they can comply with Sec. 417.2(c) by referring to 
good manufacturing practices, or establishment actions in accordance 
with good manufacturing practices. While FSIS has considered good 
manufacturing practices in developing some requirements that protect 
the public against livestock products and poultry products that are 
misbranded or economically adulterated (21 U.S.C. 453 and 601), the 
Agency has not adopted specific good manufacturing practices as part of 
its regulations.
    The Agency is publishing this notice to ensure that the owners and 
operators of federally inspected establishments are aware that 
references to good manufacturing practices, or establishment actions in 
accordance with good manufacturing practices, rather than stating the 
critical control points, critical limits, monitoring and verification 
procedures, and corrective actions themselves is insufficient to 
satisfy the requirements of Sec. 417.5(c). Part 417 requires that a 
HACCP plan be a self-contained document.
    Moreover, the function of critical control points and critical 
limits is to prevent, eliminate, or reduce to an acceptable level one 
or more food safety hazards. By definition, critical limits are maximum 
and minimum values (Sec. 417.1), and by regulation, critical limits 
must be designed, at a minimum, 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)). To determine whether 
critical limits are met and, if not, prevent the distribution of 
adulterated food and future deviations, the regulations require plan-
specific monitoring, verification, and corrective action procedures.

    Done at Washington, DC, on: January 26, 1998.
Thomas J. Billy,
Administrator.
[FR Doc. 98-2296 Filed 1-29-98; 8:45 am]
BILLING CODE 3410-DM-P