[Federal Register Volume 63, Number 62 (Wednesday, April 1, 1998)]
[Rules and Regulations]
[Pages 15739-15740]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-8432]



 ========================================================================
 Rules and Regulations
                                                 Federal Register
 ________________________________________________________________________
 
 This section of the FEDERAL REGISTER contains regulatory documents 
 having general applicability and legal effect, most of which are keyed 
 to and codified in the Code of Federal Regulations, which is published 
 under 50 titles pursuant to 44 U.S.C. 1510.
 
 The Code of Federal Regulations is sold by the Superintendent of Documents. 
 Prices of new books are listed in the first FEDERAL REGISTER issue of each 
 week.
 
 ========================================================================
 

  Federal Register/Vol. 63, No. 62/Wednesday, April 1, 1998/Rules and 
Regulations  

[[Page 15739]]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Part 417

[Docket No. 98-006N]


HACCP Plan Requirements and Meat and Poultry Product Processing 
Categories; Policy Clarification

AGENCY: Food Safety and Inspection Service.

ACTION: Policy clarification.

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

SUMMARY: The Food Safety and Inspection Service (FSIS) is publishing 
this document to clarify its policy in regard to HACCP (Hazard Analysis 
and Critical Control Points) requirements for meat and poultry 
establishments producing either multiple products that fall within a 
single processing category or single products that pass through 
multiple processing categories.

DATES: Comments must be received on or before June 1, 1998.

ADDRESSES: Submit one original and two copies of written comments to 
FSIS Docket Clerk, Docket #98-006N, U.S. Department of Agriculture, 
Food Safety and Inspection Service, Room 102, Cotton Annex, 300 12 St., 
SW, Washington, DC 20250-3700. All comments submitted in response to 
this document will be available for public inspection in the Docket 
Clerk's Office between 8:30 a.m. and 4:30 p.m., Monday through Friday.

FOR FURTHER INFORMATION CONTACT:
Patricia F. Stolfa, Assistant Deputy Administrator, Regulations and 
Inspection Methods, Food Safety and Inspection Service, U.S. Department 
of Agriculture (202) 205-0699.

SUPPLEMENTARY INFORMATION:

Background

    On July 25, 1996, FSIS published a final rule establishing new 
requirements intended to improve the safety of meat and poultry 
products and facilitate the modernization of USDA's meat and poultry 
inspection system (``Pathogen Reduction; Hazard Analysis and Critical 
Control Point (HACCP) Systems''; 61 FR 38806). The final rule requires 
all official meat and poultry establishments to implement HACCP, a 
science-based process control system. Under the new regulations, all 
official establishments are responsible for developing and implementing 
HACCP plans incorporating the controls necessary and appropriate to 
ensure that their meat or poultry products are safe.
    HACCP is a flexible system that enables establishments to develop 
and implement control systems customized to the nature and volume of 
their production. Accordingly, FSIS has promulgated regulatory 
requirements meant to provide meat and poultry establishments with the 
maximum flexibility for developing and implementing HACCP plans. FSIS 
is publishing this notice to clarify the regulatory requirements for 
establishments that wish to develop and implement a single HACCP plan 
for multiple, similar products or for a single product that passes 
through multiple processing categories.
    Under Sec. 417.2, paragraph (a) of the HACCP requirements, FSIS 
requires meat and poultry establishments to conduct a hazard analysis 
to determine what food safety hazards are reasonably likely to occur in 
the production process and identify the preventive measures it can 
apply to control those hazards. Whenever a hazard analysis reveals that 
one or more food safety hazards are reasonably likely to occur, FSIS 
requires that each establishment develop and implement a written HACCP 
plan covering each product produced by that establishment. Further, 
FSIS specifically requires that establishments develop HACCP plans for 
products that fall into the following processing categories:

    ``(i) Slaughter--all species.
    (ii) Raw product--ground.
    (iii) Raw product--not ground.
    (iv) Thermally processed--commercially sterile.
    (v) Not heat treated--shelf stable.
    (vi) Heat treated--shelf stable.
    (vii) Fully cooked--not shelf stable.
    (viii) Heat treated but not fully cooked--not shelf stable.
    (ix) Product with secondary inhibitors--not shelf stable.

    Section 417.2(b)(2) states ``A single HACCP plan may encompass 
multiple products within a single processing category identified in 
this paragraph, if the food safety hazards, critical control points 
(CCP's), critical limits, and procedures required to be identified and 
performed * * * are essentially the same, provided that any required 
features of the plan that are unique to a specific product are clearly 
delineated in the plan and are observed in practice.'' Many meat and 
poultry establishments, especially processing establishments, 
manufacture numerous products that have most of their processing steps 
in common. Allowing a single HACCP plan for such products was intended 
to simplify and improve both compliance and inspection.
    For example, an establishment producing both ready-to-eat corned 
beef and ready-to-eat roast beef could develop and implement a single 
HACCP plan for both products. The HACCP plan would identify the common 
CCP's and critical limits (cooking and cooling product in accordance 
with time/temperature combinations predetermined by the establishment), 
as well as any processing differences (the corned beef would undergo a 
curing step). In this example, compliance with HACCP requirements is 
simplified, and it is probably more efficient and cost-effective to 
develop and implement a single HACCP plan for the two products than to 
produce two separate plans. Inspection is also improved and simplified 
because FSIS inspection personnel can more efficiently and effectively 
review a single, unified HACCP plan.
    In this document, FSIS also is clarifying that meat and poultry 
establishments may develop a single HACCP plan for a single product 
that passes through multiple processing categories. It is likely that 
such HACCP plans would be developed and implemented, for the most part, 
by establishments that both slaughter (category (i)) and process 
(categories (ii) through (ix)) meat or poultry. For example, there are 
numerous establishments that slaughter, grind, and package meat for 
retail sale. There also are numerous establishments that slaughter, cut 
up, and package poultry for retail sale. Many of these and similar 
establishments probably will choose to develop and implement a single 
HACCP

[[Page 15740]]

plan covering both slaughter and processing. Developing and 
implementing a single HACCP plan for a single product often would be 
more efficient and cost effective than producing two plans (one for 
slaughter and one for processing). In many cases, FSIS inspection 
personnel will be able to more efficiently and effectively review a 
single HACCP plan that covers all of the processing (including 
slaughter) within a meat or poultry establishment.

    Done in Washington, DC: March 18, 1998.
Thomas J. Billy,
Administrator, Food Safety Inspection Service.
[FR Doc. 98-8432 Filed 3-31-98; 8:45 am]
BILLING CODE 3410-DM-P