00-22502. 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 Safety and Inspection Service, U.S. Department of Agriculture, Washington, DC 20250-3700; [phone], fax number [phone].

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 §§ 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 (§§ 318.309(d) and 381.309(d)). The procedures provided by §§ 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 (§§ 318.309(a), 381.309(a)) but not for handling process deviations (§§ 318.308(b), 381.308(b)). Also, the introductory text of §§ 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 §§ 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:

§ 318.308

[Corrected]

1. On page 34389, in the second column, § 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.

* * * * *

§ 318.309

[Corrected]

2. On page 34389, in the third column, § 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 establishment has no alternative documented procedures for handling process deviations.

* * * * *

§ 381.308

[Corrected]

3. On pages 34390 and 34391, in the first column, § 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.

* * * * *

§ 381.309

[Corrected]

4. On page 34391, in the second column, § 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.