[Federal Register Volume 65, Number 172 (Tuesday, September 5, 2000)]
[Rules and Regulations]
[Pages 53531-53533]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-22502]


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

DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Parts 318 and 381

[Docket No. 97-001C]
RIN 0583-AC35


Elimination of Requirements for Partial Quality Control Programs; 
Correction

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Correction to final rule.

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

SUMMARY: This document contains corrections to the final rule 
``Elimination of Requirements for Partial Quality Control Programs'' 
(Docket 97-001F) which was published on May 30, 2000 in the Federal 
Register (65 FR 34381). The final rule removes the remaining 
requirements pertaining to partial quality control (PQC) programs. A 
PQC program controls a single product, operation, or part of an 
operation in a meat or poultry establishment. Removal of these 
requirements will make the Federal meat and poultry inspection 
regulations more consistent with FSIS's regulations on pathogen 
reduction and hazard analysis and critical control point systems and 
give inspected establishments greater flexibility to adopt new 
technologies and methods that will improve food safety and other 
consumer protections.

DATES: Effective August 28, 2000.

FOR FURTHER INFORMATION CONTACT: Daniel L. Engeljohn, Ph.D., Director, 
Regulations Development and Analysis Division, Office of Policy, 
Program Development, and Evaluation, Food

[[Page 53532]]

Safety and Inspection Service, U.S. Department of Agriculture, 
Washington, DC 20250-3700; (202) 720-5627, fax number (202) 690-0486.

SUPPLEMENTARY INFORMATION:

Background

    The final rule that is the subject of these corrections amends the 
meat and poultry products inspection regulations by removing the 
remaining requirements pertaining to partial quality control (PQC) 
programs. A PQC program controls a single product, operation, or part 
of an operation in a meat or poultry establishment, whereas a total 
quality control (TQC) system controls all products and processes in an 
establishment. FSIS is removing the design requirements for PQC 
programs and the requirements for establishments to have PQC programs 
for certain products or processes. The amended regulations are more 
consistent with the Agency's Pathogen Reduction (PR)/Hazard Analysis 
and Critical Control Points (HACCP) regulations, and inspected 
establishments will have greater flexibility to adopt new technologies 
and methods that will improve food safety and other consumer 
protections.
    Under the PR/HACCP regulations (at 9 CFR 417.2(b)(3)), thermal 
processing establishments do not have to have HACCP plans that address 
food safety hazards associated with microbial contamination if the 
establishments comply with the canning regulations in 9 CFR 318 subpart 
G or 9 CFR 381 subpart X. The canning regulations, before amendment by 
the May 30 final rule, have allowed establishments to handle process 
deviations or finished product inspections with TQC system provisions 
or PQC programs or specified procedures for handling deviations during 
processing or through record review (9 CFR 318.308(d), 318.309(d), 
381.308(d), 381.309(d)). The PQC-related requirements pertaining to the 
control of process deviations and finished product inspections at 
canning establishments are among the requirements eliminated by the 
final rule.

Need for Correction

    As published, the final rule contained errors in the regulatory 
text that could prove to be misleading because they are inconsistent 
with the preamble explanation.
    As FSIS noted in the preamble to the final rule eliminating PQC 
requirements (65 FR 34385), the proposed rule on the subject would have 
provided options for handling process deviations and finished product 
inspections to thermal processing establishments that were not yet 
subject to the PR/HACCP regulations. During the period before the PR/
HACCP regulations were implemented in all establishments, FSIS 
maintained a policy of encouraging the early adoption of HACCP systems 
by establishments to which the PR/HACCP regulations were not yet 
applicable (63 FR 4622; January 30, 1998). Thus, the proposed options 
included HACCP plan provisions addressing food safety hazards 
associated with microbial contamination, as well as TQC system 
provisions and alternative documented procedures for handling process 
deviations. Because the final rule eliminating PQC requirements was 
published after January 25, 2000, when all FSIS-inspected 
establishments became subject to the PR/HACCP requirements, it is no 
longer necessary to provide options specifically for establishments not 
yet subject to those regulations. The final rule preamble states that 
deviations in processing are now to be handled according to HACCP plan 
or alternative procedures, and cites Secs. 318.308(d) and 381.308(d).
    In the context of the proposed rule, the cited subsections were to 
provide procedures for handling process deviations where the 
establishment's HACCP plan does not address food safety hazards 
associated with microbial contamination hazards, where there is no 
approved TQC system, or where the establishment has no alternative 
documented procedures (such as PQC programs) for handling process 
deviations. The proposed introductory text of these subsections 
paralleled the proposed introductory text for the subsections on 
alternative finished product inspection procedures (Secs. 318.309(d) 
and 381.309(d)). The procedures provided by Secs. 318.308(d), 
318.309(d), 381.308(d), and 381.309(d), and the alternatives delineated 
in the proposed introductory text of those subsections, were to be 
available to all thermal processing establishments.
    In the preamble to the final rule, FSIS further stated that it was 
including, as an option for handling process deviations or final 
product inspections, alternative documented procedures that ensure that 
only safe and stable products are shipped in commerce (65 FR 34385, 
col. 3). This option is intended to provide canning establishments with 
the flexibility to use PQC programs or other procedures for these 
purposes. However, in the regulatory text of the final rule, FSIS 
provided such an option for handling final product inspections 
(Secs. 318.309(a), 381.309(a)) but not for handling process deviations 
(Secs. 318.308(b), 381.308(b)). Also, the introductory text of 
Secs. 318.308(d) and 381.308(d), ``alternative procedures for handling 
process deviations,'' and the introductory text of 318.309(d) and 
381.309(d), ``alternative procedures for handling finished product 
inspections,'' does not state explicitly what the procedures are 
alternative to.
    FSIS is therefore correcting Secs. 318.308 (b) and (d), 381.308(b) 
and (d), 318.309(d), and 381.309(d) to reflect the Agency's intention 
to provide, for the handling of process deviations and finished product 
inspections, alternative documented procedures that ensure that 
thermally processed products will be safe and stable.

Correction of Publication

    Accordingly, the publication on May 30, 2000, of the final rule 
(Docket No. 97-054F), which was the subject of FR Docket 00-12659, is 
corrected as follows:


Sec. 318.308  [Corrected]

    1. On page 34389, in the second column, Sec. 318.308, paragraphs 
(b)(1) and (d), introductory text, are revised to read as follows:
* * * * *
    (b) * * *
    (1)(i) A HACCP plan for canned product that addresses hazards 
associated with microbial contamination, or,
    (ii) Alternative documented procedures that will ensure that only 
safe and stable product is shipped in commerce; or
    (iii) Paragraph (d) of this section.
* * * * *
    (d) Procedures for handling process deviations where the HACCP plan 
for thermally processed/commercially sterile product does not address 
food safety hazards associated with microbial contamination, where 
there is no approved total quality control system, or where the 
establishment has no alternative documented procedures for handling 
process deviations.
* * * * *


Sec. 318.309  [Corrected]

    2. On page 34389, in the third column, Sec. 318.309, paragraph (d), 
introductory text, is revised to read as follows:
* * * * *
    (d) Procedures for handling finished product inspections where the 
HACCP plan for thermally processed/commercially sterile product does 
not address food safety hazards associated with microbial 
contamination, where there is no approved total quality control system, 
or where the

[[Page 53533]]

establishment has no alternative documented procedures for handling 
process deviations.
* * * * *


Sec. 381.308  [Corrected]

    3. On pages 34390 and 34391, in the first column, Sec. 381.308, 
paragraphs (b)(1) and (d), introductory text, are revised to read as 
follows:
* * * * *
    (b) * * *
    (1)(i) A HACCP plan for canned product that addresses hazards 
associated with microbial contamination, or,
    (ii) Alternative documented procedures that will ensure that only 
safe and stable product is shipped in commerce; or
    (iii) Paragraph (d) of this section.
* * * * *
    (d) Procedures for handling process deviations where the HACCP plan 
for thermally processed/commercially sterile product does not address 
food safety hazards associated with microbial contamination, where 
there is no approved total quality control system, or where the 
establishment has no alternative documented procedures for handling 
process deviations.
* * * * *


Sec. 381.309  [Corrected]

    4. On page 34391, in the second column, Sec. 381.309, paragraph 
(d), introductory text, is revised to read as follows:
* * * * *
    (d) Procedures for finished product inspections where the HACCP 
plan for thermally processed/commercially sterile product does not 
address food safety hazards associated with microbial contamination, 
where there is no approved total quality control system, or where the 
establishment has no alternative documented procedures for handling 
process deviations.
* * * * *

    Dated: August 29, 2000.
Thomas J. Billy,
Administrator.
[FR Doc. 00-22502 Filed 9-1-00; 8:45 am]
BILLING CODE 3410-DM-P