[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]
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