00-23910. Elimination of Requirements for Partial Quality Control Programs; Certification of Scales

AGENCY:

Food Safety and Inspection Service, Department of Agriculture.

ACTION:

Proposed rule.

SUMMARY:

The Food Safety and Inspection Service (FSIS) is proposing to amend the final rule “Elimination of Partial Quality Control (PQC) Programs,” published May 30, 2000, with respect to the certification of scales for accuracy. As an alternative to State or local certification of scales for accuracy, FSIS is proposing to permit official establishments to use data from documented procedures that demonstrate compliance with National Institute of Standards and Technology Handbook 44.

DATES:

Comments must be received on or before October 3, 2000.

ADDRESSES:

Send one original and two copies of all comments to the FSIS Docket Clerk, Docket 97-001T, Room 102 Cotton Annex, 300 12th Street, SW., Washington, DC 20250-3700. All comments received in response to this notice will be considered part of the public record and will be available for viewing in the Docket Room (Room 102 Cotton Annex) between 8:30 a.m. and 4:30 p.m., Monday through Friday.

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

On May 30, 2000, FSIS published the final rule “Elimination of Requirements for Partial Quality Control Programs” (65 FR 34381).

The final rule, which became effective August 28, 2000, removed from the Federal meat and poultry products inspection regulations the remaining requirements pertaining to partial quality control (PQC) programs. A PQC program, as distinguished from a total quality control (TQC) system, controls a single product, operation, or part of an operation in a meat or poultry establishment. A TQC system controls all products and processes in an establishment. The final rule removed the design requirements for PQC programs and the requirements for establishments to have PQC programs for certain products or processes. The final rule was intended to make the regulations more consistent with the Pathogen Reduction(PR)/Hazard Analysis and Critical Control Points (HACCP) regulations and to give federally inspected establishments greater flexibility to adopt new technologies and methods that will improve food safety and other consumer protections.

Status of Establishment PQC Programs

Since publication of the final rule, some establishments have asked the Agency whether they could continue to use their PQC programs, including PQC programs for net weight. They have asked whether FSIS will continue to accept the data generated by the programs, or whether the Agency will carry out lot inspections of products otherwise subject to the programs, a process that could delay shipment of their products. Some inquirers have appeared to be under the impression that, with the final rule, PQC programs are no longer valid.

FSIS has told these inquirers that establishments can continue to implement PQC programs that are not in conflict with their HACCP plans, but that the Agency will no longer have specific requirements for such programs. As stated in the preamble to the final rule, the Agency encourages establishments to implement statistically sound quality systems, but, under the final rule, they are not required to have such systems. After the final rule becomes effective, FSIS will continue to accept and evaluate data from TQC systems or PQC programs as the Agency has in the past. The Agency will issue instructions to its field force on implementing the final rule. These instructions will reflect the Agency's expectation that establishments that continue to have PQC programs will continue to use them to control their processes.

Net Weight Control; Testing of Scales

Some persons who have contacted the Agency have asked specifically about the status of PQC programs that control net weight. Establishments believe that, if such programs are rescinded, their products would be subject to lot inspection by FSIS. FSIS has answered that the final rule does not rescind PQC programs for net weight. Establishments can continue to use PQC programs for net weight, and the Agency will continue to accept and evaluate the data from such programs.

Others have asked whether the Agency will recognize TQC system or PQC net weight program data regarding the testing of scales. They referred to the fact that the final rule removes the requirement for an establishment to have a total quality control (TQC) system provision for net weight or a partial quality control (PQC) program for net weight control in lieu of displaying, on or near its scales, a valid certification from a State or local weights and measures authority or from a State-registered or -licensed scale repair firm or person (9 CFR 317.21(b), 381.121d(b), as amended).

With respect to the amended regulations on the testing of scales (9 CFR 317.21(b), 381.121d(b)), FSIS states in the preamble of the final rule that the Agency is simply requiring that there be a certification of accuracy from State or local authorities or from a State-registered or -licensed repair firm or person. FSIS also states that establishments can continue to maintain the scale-checking provisions in their QC programs and systems (65 FR 34385). The Agency does not say whether it will accept the scale checking data generated by TQC systems or PQC programs. The inference to be made from the final rule is that the only documentation of the accuracy of scales that FSIS will accept is a certification of accuracy by State or local authorities or by a State-registered or licensed repair firm or person. FSIS wishes to clarify, however, that the Agency intends to accept and evaluate data on net weight and on the accuracy of scales as well as other types of TQC or PQC data supporting an establishment's compliance with regulatory requirements.

FSIS notes that the other regulations on accuracy and testing of scales (9 CFR 317.20, 317.21(a), 381.121c, 381.121d(a)) continue in force. FSIS also notes that in the past, when evaluating TQC and PQC net weight program provisions for testing scales, FSIS has always expected the systems and programs to ensure compliance with the regulations and the requirements of National Institute of Standards and Technology Handbook 44. When evaluating data and information from TQC systems, PQC programs, or other documented procedures relating to the accuracy of scales, the Agency will continue to expect the data to reflect compliance or non-compliance with the Handbook 44 requirements.

FSIS is, therefore, proposing to amend the final rule to permit establishments to provide for alternative documentation that scales meet the requirements of NIST Handbook 44 and the other regulatory requirements for accuracy and testing of scales, in lieu of State or local certification of scales. Under this proposal, such documentation could be data or information generated by a TQC system or PQC program or records of tests conducted in accordance with NIST Handbook 44 requirements or other requirements of the regulations.

Executive Order 12866 and Regulatory Flexibility Act

This proposed rule has been determined to be not “significant” within the meaning of Executive Order 12866. This rulemaking is not expected to impose any new costs on the regulated industry or on other sectors of the economy.

The Administrator has determined that this proposed rule would not have a significant economic impact on a substantial number of small entities. Most of the entities that would be affected by this proposal are small business establishments, under Small Business Administration criteria (500 or fewer employees).

The proposal would permit establishments to use data from documented procedures to demonstrate that their scales comply with the requirements of NIST Handbook 44, in lieu of certification by State or local authorities or State-licensed repair services or persons. The documented procedures could include TQC systems or PQC programs for net weight. Approximately 240 establishments that operate TQC systems and several hundred establishments that have PQC programs for net weight could continue to use those systems and programs that control the accuracy of scales. In other words, establishments would not have to change their current practices for ensuring the accuracy of their scales to comply with this proposal. The effect of this proposal on the affected establishments would therefore not be significant.

Comment Period

This proposal is intended to make a provision of the May 30, 2000, final rule more flexible. During the rulemaking proceeding that culminated in the final rule, interested parties were given the opportunity to comment on a May 18, 1999, proposed rule and the comments received were favorable. None of the comments addressed the matter of certification of scales for accuracy. FSIS therefore regards this matter as relatively non-controversial.

Further, given that the final rule is already in effect, FSIS concludes that any clarifying amendments to the regulation should be made as close to its effective date as possible. For these reasons, FSIS is providing a short, 15-day comment period from the date of publication of this proposed rule in the Federal Register.

Additional Public Notification

Public awareness of all stages of rulemaking and policy development is important. Consequently, in an effort to better ensure that minorities, women, and persons with disabilities are aware of this final rule, FSIS will announce it and provide copies of this Federal Register publication in the weekly FSIS Constituent Update. FSIS communicates the Constituent Update by fax to over 300 organizations and individuals and makes it available on line through the FSIS web page located at “http://www.fsis.usda.gov”. The update provides information on FSIS policies, procedures, regulations, Federal Register notices, FSIS public meetings, recalls, and other information that could affect or would be of interest to the Agency's constituents/stakeholders. The constituent fax list consists of industry, trade, and farm groups, consumer interest groups, allied health professionals, scientific professionals, and other individuals who have requested to be included. Through these various channels, FSIS is able to provide information to a much broader, more diverse audience. For more information and to be added to the constituent fax list, readers of this document may fax their requests to the Congressional and Public Affairs Office, at [phone].

List of Subjects

9 CFR Part 317

• Meat inspection
• Reporting and recordkeeping requirements

9 CFR Part 381

• Poultry and poultry products
• Reporting and recordkeeping requirements

For the reasons set forth in the preamble, FSIS is proposing to amend 9 CFR, chapter III, the Federal meat and poultry inspection regulations, as follows:

PART 317—LABELING, MARKING DEVICES, AND CONTAINERS

1. The authority citation for part 317 would continue to read as follows:

Authority: 21 U.S.C. 601-695; 7 CFR 2.18, 2.53.

2. Paragraph (b) of § 317.21 would be revised as follows:

§ 317.21

Scales; testing of.

(a) * * *

(b) The operator of each official establishment shall display on or near each scale a valid certification of the scale's accuracy from a State or local government's weights and measures authority or from a State registered or licensed scale repair firm or person, or shall have alternative documented procedures showing that the scale meets the requirements of NIST Handbook 44.

PART 381—POULTRY PRODUCTS INSPECTION REGULATIONS

3. The authority citation for part 381 would continue to read as follows:

Authority: 7 U.S.C. 138f, 450; 21 U.S.C. 451-470; 7 CFR 2.18, 2.53.

4. Paragraph (b) of § 381.121d would be revised as follows:

§ 381.121d

Scales; testing of.

(a) * * *

(b) The operator of each official establishment shall display on or near each scale a valid certification of the scale's accuracy from a State or local government's weights and measures authority or from a State registered or licensed scale repair firm or person, or shall have alternative documented procedures showing that the scale meets the requirements of NIST Handbook 44.

Done at Washington, DC, on September 12, 2000.

Thomas J. Billy,

Administrator.