[Federal Register Volume 66, Number 200 (Tuesday, October 16, 2001)]
[Rules and Regulations]
[Pages 52484-52486]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-25922]


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DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Parts 317 and 381

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


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

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Final rule.

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SUMMARY: The Food Safety and Inspection Service (FSIS) is amending its 
regulations governing the certification for accuracy of scales used in 
federally inspected meat and poultry establishments. Under the final 
rule, official establishments may rely on State or local certification 
or data from documented procedures that demonstrate compliance with the 
National Institute of Standards and Technology Handbook 44. This final 
rule addresses an issue raised after publication of the May 30, 2000, 
final rule ``Elimination of Requirements for Partial Quality Control 
(PQC) Programs,'' by clarifying that establishments may rely on data 
from documented procedures, and that FSIS will verify establishment 
compliance with regulations on the accuracy of scales based on data 
maintained by the establishments.

EFFECTIVE DATE: This final rule is effective November 15, 2001.

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

    After publication of the final rule, some establishments asked the 
Agency whether they could continue to use their PQC programs, including 
PQC programs for net weight. Some persons who contacted the Agency 
asked specifically about the status of PQC programs that control net 
weight. Some establishments believed that, if such programs were 
rescinded, their products would be subject to lot inspection by FSIS. 
FSIS 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 verify their compliance with net weight 
requirements based on data from such programs.
    Others asked whether the Agency would recognize TQC system data 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

[[Page 52485]]

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)), the May 30 final rule required that there 
be a certification of accuracy from State or local authorities or from 
a State-registered or -licensed repair firm or person. The preamble to 
the final rule also stated that establishments could continue to 
maintain the scale-checking provisions in their QC programs and systems 
(65 FR 34385). The final rule did not say whether the Agency, in the 
course of its verification activities, would accept the scale checking 
data generated by TQC systems or PQC programs. The inference that could 
be made from the May 30 final rule was that the only documentation of 
the accuracy of scales that FSIS would accept is a certification of 
accuracy by State or local authorities or by a State-registered or 
licensed repair firm or person.
    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, 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 (NIST) 
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.
    On September 18, 2000, FSIS therefore proposed to amend the May 30 
final rule to clarify that establishments could provide 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 (65 FR 56262). 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.

Comments Received

    FSIS received comments on the proposal from a trade association 
representing food processors, two officials of the union representing 
FSIS food inspectors, and an engineer employed by a food equipment 
manufacturer. The trade association supported the proposal because it 
would give official establishments the flexibility to use data from TQC 
systems or PQC programs to ensure compliance with net weight 
regulations.
    Two officials of the union that represents FSIS food inspectors 
opposed the proposal on the grounds that: (1) it would remove scale 
certification requirements; (2) it would result in product adulteration 
by chemicals and food ingredients in amounts greater than regulations 
permit; (3) the proposal falsely claimed that ``HACCP programs'' could 
control scale certification; and (4) Handbook 44 is an unenforceable 
guideline.
    The Agency responds to these points as follows: (1) Under the 
proposal, scale certification requirements would be essentially the 
same as they were from the time when the current net weight regulations 
were promulgated until the May 30, 2000, final rule. Before the final 
rule, which became effective August 28, 2000, establishments were able 
to use data from PQC programs or TQC systems to ensure compliance of 
scales with net weight regulations. This meant that the scales had to 
be in compliance with Handbook 44 specifications.
    (2) The scale certification provisions addressed by the proposal 
are intended to help ensure the compliance of meat and poultry products 
with net weight requirements. The accuracy of scales helps to ensure 
the accuracy of product net weight statements. The chemical and food 
ingredient example does not support the commenters' point because food 
ingredient or chemical restrictions are typically expressed as 
percentages of products or product formulations. That means that if the 
same scale were used to weigh the meat and other ingredients of a 
product, there would still be compliance with the restricted ingredient 
regulations.
    (3) The proposal didn't discuss the use of HACCP plans to control 
scale accuracy. It did state that establishments could implement PQC 
programs that were ``not in conflict'' with HACCP plans (65 FR 56262).
    (4) Handbook 44, ``Specifications, Tolerances, and Other Technical 
Requirements for Weighing and Measuring Devices,'' is incorporated by 
reference in the net weight regulations. The requirement for scales to 
be tested at least once a year in accordance with Handbook 44 (9 CFR 
317.21(a), 381.121d(a)) has been in effect since 1991 and is not a 
subject of this rulemaking.
    The equipment company engineer also objected to the use of NIST 
Handbook 44 criteria as inappropriate for determining the accuracy of 
scales used in official establishments. This commenter stated that the 
Handbook 44 criteria conflict with NIST Handbook 130 requirements 
regarding variations from net quantity declarations on packaged 
commodities.
    FSIS notes that Handbook 130, ``Uniform Laws and Regulations in the 
Areas of Legal Metrology and Fuel Engine Quality,'' is not directly 
applicable to net weight determinations for meat and poultry products 
and is not incorporated by reference into the FSIS regulations. NIST 
Handbook 133, ``Checking the Net Contents of Packaged Goods,'' 
including the provisions for maximum allowable variation in net weight, 
applies specifically to FSIS-regulated products and is incorporated by 
reference in the FSIS regulations governing procedures for determining 
net weight compliance (9 CFR 317.19, 381.121b) for those products. No 
changes respecting these requirements were envisioned in the proposal. 
Further, the comment was not relevant to the proposal because the 
proposal was not intended to address the criteria for determining the 
accuracy of scales, but only the form of documentation of that 
accuracy.

Executive Order 12866 and Regulatory Flexibility Act

    This final 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 final rule will not have 
a significant economic impact on a substantial number of small 
entities. Most of the entities that will be affected by this final rule 
are small business establishments, under Small Business Administration 
criteria (500 or fewer employees). This final rule will 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 may 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 can continue to 
use those systems and programs that control the accuracy of scales. In 
other words, establishments will not have to change their practices for 
ensuring the accuracy of their scales to comply with this rule. The 
effect of this final rule on

[[Page 52486]]

the affected establishments will therefore not be significant.

Executive Order 12988

    This final rule has been reviewed under Executive Order 12988, 
Civil Justice Reform. States and local jurisdictions are preempted by 
the Federal Meat Inspection Act (FMIA) and the Poultry Products 
Inspection Act (PPIA) from imposing any marking or packaging 
requirements on federally inspected meat and meat products or poultry 
products that are in addition to, or different than, those imposed 
under the FMIA and PPIA. States and local jurisdictions may, however, 
exercise concurrent jurisdiction over meat and poultry products that 
are outside official establishments for the purpose of preventing the 
distribution of meat or poultry products that are misbranded or 
adulterated under the FMIA or PPIA. States and local jurisdictions also 
may exercise concurrent jurisdiction, for the same purpose, over 
imported meat and poultry products that are not at an official 
establishment after the entry of such imported articles into the United 
States.
    This final rule is not intended to have retroactive effect.
    There are no applicable administrative procedures that must be 
exhausted prior to any judicial challenge to the provisions of this 
final rule. However, the administrative procedures specified in 9 CFR 
306.5 and 381.35 must be exhausted prior to any judicial challenge of 
the application of the provisions of this final rule, if the challenge 
involves any decision of an FSIS employee relating to inspection 
services provided under the FMIA or PPIA.

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 amending 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 continues to read as 
follows:

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


    2. Paragraph (b) of Sec. 317.21 is 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 has been 
tested for accuracy in accordance with the requirements of NIST 
Handbook 44.

PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS

    3. The authority citation for part 381 continues 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 is 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 has been 
tested for accuracy in accordance with the requirements of NIST 
Handbook 44.

    Done at Washington, DC, on October 10, 2001.
Thomas J. Billy,
Administrator.
[FR Doc. 01-25922 Filed 10-15-01; 8:45 am]
BILLING CODE 3410-DM-P