[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]
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