[Federal Register Volume 65, Number 181 (Monday, September 18, 2000)]
[Proposed Rules]
[Pages 56262-56264]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-23910]


 ========================================================================
 Proposed Rules
                                                 Federal Register
 ________________________________________________________________________
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 This section of the FEDERAL REGISTER contains notices to the public of 
 the proposed issuance of rules and regulations. The purpose of these 
 notices is to give interested persons an opportunity to participate in 
 the rule making prior to the adoption of the final rules.
 
 ========================================================================
 

  Federal Register / Vol. 65, No. 181 / Monday, September 18, 2000 / 
Proposed Rules  

[[Page 56262]]



DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Parts 317 and 381

[Docket No. 97-001T]
RIN: 0583-AC35


Elimination of Requirements for Partial Quality Control Programs; 
Certification of Scales

AGENCY: Food Safety and Inspection Service, Department of Agriculture.

ACTION: Proposed rule.

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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; 
(202) 720-5627, fax number (202) 690-0486.

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

[[Page 56263]]

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 (202) 720-5704.

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 Sec. 317.21 would be revised as follows:


Sec. 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 Sec. 381.121d would be revised as follows:


Sec. 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.


[[Page 56264]]


    Done at Washington, DC, on September 12, 2000.
Thomas J. Billy,
Administrator.
[FR Doc. 00-23910 Filed 9-15-00; 8:45 am]
BILLING CODE 3410-DM-P