[Federal Register Volume 63, Number 44 (Friday, March 6, 1998)]
[Rules and Regulations]
[Pages 11104-11105]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-5770]
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DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
9 CFR Part 417
[Docket No. 98-003N]
Establishment Review of Product Production Records
AGENCY: Food Safety and Inspection Service, USDA.
ACTION: Notice on complying with the HACCP system regulations.
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SUMMARY: The Food Safety and Inspection Service is publishing this
document to provide information to owners and operators of federally
inspected establishments about what actions they must take to comply
with the requirement, in the hazard analysis and critical control point
system regulations, to review the records associated with production of
a product prior to its shipment for distribution. The regulations do
not prescribe how establishments meet this requirement and, thus, are
sufficiently flexible to accommodate various records' review schemes.
However, establishments must determine that all critical limits were
met and, when appropriate, that corrective actions were taken.
Establishments must also ensure the completeness of their records
before shipping the product for distribution.
FOR FURTHER INFORMATION CONTACT: Patricia F. Stolfa, Assistant Deputy
Administrator, Regulations and
[[Page 11105]]
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 part 417 of the regulations, Hazard Analysis and Critical
Control Point (HACCP) Systems.*
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* 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.
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Part 417 requires federally inspected establishments to determine
the food safety hazards reasonably likely to occur in the production
process and to develop and implement a HACCP plan, or plans, to control
these hazards (Sec. 417.2(a), (b), and (c)). Under part 417,
establishments control food safety hazards through monitoring
procedures that apply critical limits at critical control points and,
when deviations occur, by taking corrective actions that restore
establishment control and keep adulterated food out of commerce, as
documented in records that are subject to establishment verification
(Secs. 417.2(c), 417.3, and 417.5).
To ensure that HACCP plans are implemented effectively and function
as intended to control food safety hazards and prevent the distribution
of adulterated livestock products and poultry products, part 417 also
requires that establishments conduct validation and verification
activities (Sec. 417.4(a)). Verification includes review of the records
that the establishment must keep to document a HACCP plan in operation
(Sec. 417.5(a)(3)). For a particular product, verification does not end
until, in accordance with Sec. 417.5(c), the establishment has reviewed
the records associated with its production.
Paragraph (c) of Sec. 417.5 provides that:
Prior to shipping product, the establishment shall review the
records associated with the production of that product, documented
in accordance with this section, to ensure completeness, including
the determination that all critical limits were met and, if
appropriate, corrective actions were taken, including the proper
disposition of product. Where practicable, this review shall be
conducted, dated, and signed by an individual who did not produce
the record(s), preferably by someone trained in accordance with
Sec. 417.7 of this part, or the responsible establishment official.
As federally inspected establishments prepare to implement HACCP plans
under part 417, the Agency has received inquiries about what actions
establishments must take to comply with this paragraph of the
regulations. In particular, people have asked whether an establishment
can satisfy the requirement for a final, records-based verification by
using any procedure other than one in which a single reviewer looks at
all the records for the product as it is assembled on the shipping dock
and loaded for transportation from the establishment.
FSIS is publishing this notice to provide information to owners and
operators of federally inspected establishments on the types of
procedures that the Agency anticipates will satisfy this requirement.
The essence of Sec. 417.5(c) is to require that establishments take
responsibility not only for developing and implementing HACCP plans,
but also for maintaining control of products until they ensure that
establishment personnel have applied those plans appropriately and
effectively. FSIS has not prescribed how establishments comply, and it
views the regulations as sufficiently flexible to accommodate records'
review schemes in addition to the procedure described in the previous
paragraph.
Establishment personnel can review production records at any point
after processing and before shipment of the product, including, for
example, at the end of the day of production before a product goes into
on-site storage, while a product is in on-site storage, or during
preparation of shipping documents before assembling product for
transportation from the establishment. Consistent with the regulations,
an establishment also can initiate checks for records' completeness
earlier and accomplish the review in stages. For example, an
establishment that slaughters and bones cattle carcasses one day and
prepares ground beef the next could make one reviewer responsible for
performing slaughter and boning records' review on the first day and
carry the review forward to the second day, when another reviewer
assumes responsibility for the remaining tasks necessary to ensure that
there has been an establishment determination that all critical limits
were met and, if appropriate, corrective actions were taken and that
production records are otherwise complete and then signs and dates the
review. In addition, establishments that maintain records on computers
in accordance with Sec. 417.5(d) may be able to accomplish much of the
record checking electronically.
The crucial concern is that there be verification that
establishment controls have ensured proper product disposition, so that
adulterated product is not distributed. FSIS has not, at this point,
ruled out the possibility that a company might operate in compliance
with this regulation despite the fact that the records-based
verification is being conducted when the company transfers a product
from the preparation establishment to another, storage location and
holds the product there, maintaining control of the product, until the
company completes the review and releases the product for shipment to
retail outlets. Industry members interested in instituting a records'
review scheme that includes this type of feature may wish to consult
with the Agency about the types of safeguards needed to ensure that
product is not shipped for distribution until the required verification
is performed. (In Secs. 318.309(d)(1)(viii) and 381.309(d)(1)(viii),
the canning and canned products' regulations address a similar
situation as an exception, for which an establishment must obtain area
supervisor approval, to the prohibition against shipping product from
the establishments before the end of the required incubation period.)
FSIS also notes that establishment compliance with part 417
requirements does not affect the applicability of section 10 of the
FMIA or section 9(a) of the PPIA (21 U.S.C. 610 and 458(a)); in
particular, transporting, or offering for transportation,adulterated
livestock products or poultry products is prohibited.
Done at Washington, DC, on: February 27, 1998.
Thomas J. Billy,
Administrator.
[FR Doc. 98-5770 Filed 3-5-98; 8:45 am]
BILLING CODE 3410-DM-P
