[Federal Register: May 4, 2004 (Volume 69, Number 86)]
[Notices]
[Page 24556-24558]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04my04-20]
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DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
[Docket No. 04-009N]
Review of Establishment Data by Inspection Program Personnel
AGENCY: Food Safety and Inspection Service, USDA.
ACTION: Notice of Availability.
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SUMMARY: The Food Safety and Inspection Service (FSIS) is announcing
the availability of FSIS Directive 5000.2, ``Review of Establishment
Data by Inspection Program Personnel.'' In December 2003, the Agency
issued FSIS Notice 54-03 ``Review of Establishment Data by Inspection
Program Personnel'' to clarify that FSIS inspection program personnel
have access to a wide range of establishment food safety records under
the Hazard Analysis and Critical Control Point (HACCP) Systems
regulations and to ensure that inspection program personnel understand
that certain food safety records kept by the establishment are subject
to review on a regular basis. FSIS has revised Notice 54-03 and is
reissuing it as an FSIS Directive.
ADDRESSES: Copies of FSIS Directive 5000.2, ``Review of Establishment
Data by Inspection Program Personnel,'' are available from the FSIS
Docket Clerk, FSIS Docket Room, Room 102, 300 12th Street, SW.,
Washington, DC 20250-3700. An electronic copy of the document is also
available on the Internet at: http://www.fsis.usda.gov/OPPDE/rdad/FSISDirectives/
5000.2.pdf.
FOR FURTHER INFORMATION CONTACT: Dr. Lynn Dickey, Director, Regulations
and Petitions Policy Staff, Office of Policy and Program Development,
Food Safety and Inspection Service, U.S. Department of Agriculture,
(202) 720-5627.
SUPPLEMENTARY INFORMATION:
Background
Under the FSIS HACCP regulations, establishments are required to
conduct a hazard analysis to determine the food safety hazards
reasonably likely to occur in their production processes and to
identify the preventive measures that they can apply to control those
hazards (9 CFR 417.2(a)). Whenever a hazard
[[Page 24557]]
analysis reveals that a food safety hazard is reasonably likely to
occur in the production process, establishments are required to develop
and implement a written HACCP plan for each product that includes
specified control measures for each hazard so identified (9 CFR
417.2(b) and (c)). Establishments are required to reassess their HACCP
plans at least annually or whenever a change occurs that could affect a
hazard analysis or a HACCP plan (9 CFR 417.4 (a)(3)).
In addition, the HACCP regulations require that establishments
maintain certain records that document the establishments' HACCP plans
(9 CFR 417.5). These records include, among other records, the written
hazard analysis prescribed by 9 CFR 417.2(a), including all
documentation that supports that analysis (9 CFR 417.5(a)). The HACCP
regulations also require that establishments retain certain HACCP-
related records, including records that document verification
procedures and results, for a certain period of time. For slaughter
activities or refrigerated products, establishments are required to
retain records for at least one year (9 CFR 417.5(e)). For frozen
preserved, or shelf-stable products, establishments are required to
retain records for at least two years (9 CFR 417.5(e)). All records
required under the HACCP regulations must be available to FSIS for
official review and copying (9 CFR 417.5(f)). FSIS verifies the
adequacy of an establishment's HACCP plan through various means,
including on-site observations, record reviews, and sample collections
and analyses (9 CFR 417.8).
Establishments may conduct certain testing or monitoring activities
as part of their HACCP plans, or as programs that could affect the
hazard analysis but that may or may not be referenced in the HACCP
plan. For example, establishments may perform testing or monitoring
activities as a part of a prerequisite program or conduct product
testing to comply with the specifications of business customers.
Because the results of such testing and monitoring activities could
affect the establishment's hazard analysis, FSIS considers records that
document the results of any monitoring or of any testing conducted by
an establishment as supporting documentation for the hazard analysis,
which, under 9 CFR 417.5, must be maintained by the establishment and
be made available for FSIS review.
Furthermore, because the HACCP regulations require that
establishments retain certain HACCP-related records for at least one
year, or for frozen, preserved, or shelf-stable products, for at least
two years, FSIS expects that establishments will retain records that
document the results of any testing or any monitoring activities,
including records that document the results of tests conducted to meet
a purchaser's specifications, for this same period of time. The Agency
has determined that such records are subject to the record retention
provisions of the HACCP regulations because they document procedures
and results that FSIS inspection program personnel may rely on to
verify the adequacy of an establishments' HACCP plan. Records that
document verification procedures and results are subject to the HACCP
record retention provisions in 9 CFR 417.5 (e).
FSIS issued Notice 54-03 in December of 2003 to inform FSIS
inspection program personnel that they should be aware of all
monitoring and of all testing related to food safety conducted by an
establishment and to verify these records as part of the HACCP
inspection procedures. The Agency reissued the notice in April of 2004
as an FSIS Directive to make it consistent with Directive 10,010.1,
``Microbiological Testing Program for Escherichia coli O157:H7 in Raw
Ground Beef.'' Directive 5000.2 instructs inspection program personnel
to ask establishments to make available for review the data that is
generated by any monitoring and any testing related to food safety to
ensure that this data is available when inspection program personnel
are verifying HACCP records. Directive 5000.2 makes clear that
inspection program personnel should review any food safety data that
has been generated by the establishment at the weekly HACCP meeting.
Directive 5000.2, as did Notice 54-03, instructs FSIS inspection
program personnel to examine an establishment's testing and monitoring
results to determine whether these documents indicate that the
establishment has failed to recognize and correct any food safety
concerns. Thus, the directive makes clear that records that document
the results of any testing and of any monitoring related to food safety
that are performed by an establishment, whether such activities are
incorporated into the establishment's HACCP plan, referenced in a HACCP
plan, or considered as separate food safety activities, are supporting
documentation for the establishment's hazard analysis. The Agency
expects that establishments will make such records available to FSIS
inspection program personnel upon request.
To enhance its inspection program personnel's understanding of the
policies described in FSIS Directive 5000.2, and to assist inspection
program personnel develop the critical thinking skills that they need
to apply these policies in the establishment setting, FSIS has issued
new scenarios under its Interactive Knowledge Exchange (IKE) service.
IKE is a tool available to all Field Operations employees to assist
them in keeping current and correlated on regulatory requirements,
directives, notices, HACCP, Sanitation SOP, and FSIS sampling programs.
Additional Public Notification
Public awareness of all segments of rulemaking and policy
development is important. Consequently, in an effort to better ensure
that the public, and in particular minorities, women, and persons with
disabilities, are aware of this notice, FSIS will announce it on-line
through the FSIS Web page located at http://www.fsis.usda.gov.
The Regulations.gov Web site is the central online rulemaking
portal of the United States government. It is being offered as a public
service to increase participation in the Federal government's
regulatory activities. FSIS participates in Regulations.gov and will
accept comments on documents published on the site. The site allows
visitors to search by keyword or Department or Agency for rulemakings
that allow for public comment. Each entry provides a quick link to a
comment form so that visitors can type in their comments and submit
them to FSIS. The Web site is located at http: //http://www.regulations.gov.
FSIS also will make copies of this Federal Register publication
available through the FSIS Constituent Update, which is used to provide
information regarding FSIS policies, procedures, regulations, Federal
Register notices, FSIS public meetings, recalls, and other types of
information that could affect or would be of interest to our
constituents and stakeholders. The update is communicated via Listserv,
a free e-mail subscription service consisting of industry, trade, and
farm groups, consumer interest groups, allied health professionals,
scientific professionals, and other individuals who have requested to
be included. The update also is available on the FSIS Web page. Through
Listserv and the Web page, FSIS is able to provide information to a
much broader, more diverse audience.
[[Page 24558]]
Done at Washington, DC, on April 28, 2004.
Barbara Masters,
Acting Administrator.
[FR Doc. 04-10030 Filed 5-3-04; 8:45 am]