[Federal Register Volume 61, Number 86 (Thursday, May 2, 1996)]
[Proposed Rules]
[Pages 19578-19590]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-10795]
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DEPARTMENT OF AGRICULTURE
9 CFR Parts 304, 308, 317, 318, 319, and 381
[Docket No. 95-032P]
RIN 0583-AB93
Elimination of Prior Approval Requirements for Establishment
Drawings and Specifications, Equipment, and Certain Partial Quality
Control Programs
AGENCY: Food Safety and Inspection Service, USDA.
ACTION: Proposed rule.
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SUMMARY: The Food Safety and Inspection Service (FSIS) is proposing to
amend the Federal meat and poultry products inspection regulations by
removing current requirements for prior approval by FSIS of
establishment drawings, specifications, and equipment prior to their
use in official establishments. Requirements involving the comparison
of blueprints and specifications with actual facilities and equipment
would end. These amendments would provide the regulated industry with
the flexibility to design facilities and equipment in the manner they
deem best to maintain a sanitary environment for food production. FSIS
would continue to verify through inspection that good sanitation is
being achieved. Similarly, FSIS is proposing to end its prior approval
of most establishment-operated partial quality control programs, which
are used by establishments to control certain kinds of food processing
and product characteristics. This change would make it possible for
establishments to develop and implement quality control programs
without first having to receive permission from FSIS to do so. This
action is being taken to streamline and modernize the meat and poultry
food safety regulations, to separate the roles of Government and the
regulated industry, to encourage innovations that will improve food
safety, and to remove unnecessary regulatory burdens on inspected meat
and poultry establishments. In addition, the proposal represents an
important shift away from FSIS's ``command-and-control'' regulatory
approach and toward a less bureaucratic approach consistent with the
Agency's food safety mission.
DATES: Comments must be received on or before: July 1, 1996.
ADDRESSES: Please send an original and two copies of comments on this
proposed rule to FSIS Docket Clerk, DOCKET #93-032P, Room 4352 South
Agriculture Building, Washington, DC 20250-3700. Oral comments, as
provided under the Poultry Products Inspection Act, should be directed
to the person listed under FOR FURTHER INFORMATION CONTACT. Copies of
FSIS reference materials cited in this proposal are available for
review in the FSIS docket room.
FOR FURTHER INFORMATION CONTACT: Ms. Patricia F. Stolfa, Acting Deputy
Administrator, Science and Technology, FSIS, Room 402 Annex Building,
Washington, DC 20250-3700; (202) 205-0699.
SUPPLEMENTARY INFORMATION:
Background
The Federal Meat Inspection Act (FMIA) (21 U.S.C. 601 et seq.), and
the Poultry Products Inspection Act (PPIA) (21 U.S.C. 451 et seq.)
direct the Secretary of Agriculture to maintain inspection programs
designed to assure the public that meat and meat food products (meat
products) and poultry and poultry products (poultry products) are safe,
wholesome, not adulterated, and properly marked, labeled, and packaged.
FSIS carries out the mandates of these statutes by administering a
continuous in-establishment inspection program for meat and poultry
products that are shipped in interstate and foreign commerce or in
``designated'' States. A number of the States operate meat and poultry
inspection programs for product shipped intrastate. Under the FMIA and
PPIA, such programs must impose requirements ``at least equal'' to the
Federal requirements.
The FMIA and PPIA require the Secretary to provide, among other
things, for the inspection of establishments to assure that the
conditions under which meat and poultry products are produced are
sanitary. The Acts also require the Secretary to prescribe rules and
regulations governing the sanitary conditions of official
establishments (21 U.S.C. 608 and 456). Pursuant to these provisions,
the meat and poultry inspection regulations currently prescribe ``prior
approval'' or approval-before-use by FSIS of facility drawings and
specifications and of equipment used in official establishments. The
regulations also provide for the prior approval of certain quality
control programs, known as partial quality control (PQC) programs,
before their use by official establishments.
Current Prior Approval Procedures
Currently, applicants seeking Federal inspection must submit to
FSIS blueprints and drawings with specifications that exactly
illustrate the applicant's establishment as it exists or is proposed to
exist (9 CFR 304.2(a), 308.2, and 381.19). Before inspection is
granted, FSIS officials in the field and in Washington, D.C., review
the blueprints and drawings and the facility they represent to
determine whether the facility meets the requirements of the meat and
poultry inspection regulations, which are intended to ensure that
products can be produced in a sanitary environment. Owners or operators
of establishments intending to add structures or remodel their existing
facility must also submit blueprints and drawings with specifications
to FSIS for review before beginning any new construction (9 CFR 404.2,
308.2, and 381.19). During FY 1994, FSIS technical personnel reviewed
about 2,900 sets of blueprints for new or modified facilities.
Federally inspected establishments or equipment manufacturers must
go through a similar process of prior submission for review and
approval of most equipment used in preparing or handling edible meat
and poultry products or ingredients (9 CFR 308.5 and 381.53). FSIS
requires that establishment owners or operators wishing to use new
equipment submit any information FSIS needs to review new equipment,
including assembly-type drawings and a list showing the materials of
which parts are made. The primary objectives of the FSIS review are to
determine whether the equipment can be readily cleaned and inspected
for its sanitary condition. In some instances, FSIS also requires that
the equipment be used on a trial basis before approval is granted (9
CFR 308.5(d) and 381.53(a)(4)). FSIS technical personnel review more
than 2,500 submissions of equipment specifications each year, and
approximately 650 pieces of new equipment require a trial installation
before being accepted for use.
[[Page 19579]]
Also, prior-approval procedures exist for numerous establishment-
operated partial quality control programs. This means that companies
must come to FSIS for permission before they can initiate or modify
processes or controls intended to ensure that products have desired
characteristics and that processes are stable.
The prior-approval process is a feature of FSIS's traditional
``command-and-control'' regulatory approach. While prior approval
provides assurance that equipment, facilities, or processes, as
designed, meet certain requirements that are intended to assure food
safety or quality, they reflect the emphasis of the current system on
closely observing the means by which establishments maintain sanitation
and produce safe food. This feature of the current system is an
inappropriate allocation of responsibility between the Agency and
establishments. It is an obstacle and too often a deterrent to
innovation by establishments seeking to improve operations, and
contributes to unproductive use of FSIS resources both in managing the
approval system and policing establishment compliance with approved
facility and equipment specifications.
In addition, elimination of prior-approval requirements is
consistent with the principles articulated in FSIS's February 3, 1995,
Pathogen Reduction/Hazard Analysis and Critical Control Points (HACCP)
proposal (60 FR 6774). HACCP and the FSIS food safety strategy are
based on the principle that sanitary measures and science-based
preventive process controls should be built into the food production
system to reduce or eliminate food safety hazards. Establishment
management should be responsible for designing and implementing such
process controls, as well as for developing and maintaining standard
operating procedures (SOP's) for its sanitation programs. However, the
current system imposed by FSIS inappropriately allocates responsibility
between the Agency and the industry and impedes the ability of
establishment management to implement innovative food safety
strategies. Establishments conducting their own hazard analyses and
developing the HACCP plans to meet FSIS's food safety objectives will
determine whether facility layouts, equipment operating
characteristics, and other technical components of the manufacturing
process will result in products that meet required standards.
FSIS's reliance on prior approvals also contrasts with both the
practices of the remainder of the food industry as regulated by the
U.S. Food and Drug Administration and the practices of a significant
number of countries that have meat and poultry inspection systems that
provide a level of food safety assurance equivalent to that of the
United States. With the single exception of Canada, whose meat and
poultry regulatory system is intertwined with that of the United
States, none of these other countries relies on prior-approval systems
to ensure that equipment does not adulterate product.
Anticipated Changes in Inspection
The elimination of the prior approval systems proposed here would
change the manner in which FSIS conducts certain aspects of its
inspection. Under the current prior approval system, FSIS focuses
substantial attention on identifying specific design-related conditions
affecting food safety, which should be the responsibility of the
establishment. For example, FSIS not only performs prior approval of
facility blueprints and equipment, but also inspection tasks to verify
that the facility as constructed conforms to the blueprint and that
equipment meets approved design specifications. This reflects the fact
that the FSIS regulatory system has, in effect, taken responsibility
for these matters. Similarly, many establishments currently lack a
written sanitation plan and do not systematically ensure daily
maintenance of good sanitation. In order to compensate for this lack,
FSIS inspectors focus considerable attention on sanitation conditions
and practices that are more appropriately the establishment's
responsibility.
Under this proposal, FSIS would no longer control through prior
approval the design specifications for buildings and equipment.
Instead, FSIS would focus its regulatory and inspectional attention on
determining whether an establishment is successfully meeting sanitation
standards. Establishments would ensure that the design of buildings and
equipment is appropriate for sanitary food production and for
maintaining good sanitary conditions in accordance with broad
sanitation principles. In addition, the FSIS proposal to require
establishments to adopt sanitation SOP's of their own design, requires
establishments to identify the elements of good sanitation required to
prevent direct product contamination, carry out the SOP's on a daily
basis, and achieve acceptable sanitation results. Concurrent with this
action, FSIS inspection activities under SOP's and HACCP would be
restructured to focus not on the building or equipment design, or on
FSIS approval status, but on whether good sanitation is, in fact, being
maintained.
In concert with this proposal, FSIS would review and revise its
existing regulations and guidelines to avoid real or de facto
prescriptions that are inconsistent with the approach outlined here.
This review is underway and public comments on this process were
invited in an advance notice of proposed rulemaking, the ``FSIS Agenda
for Change,'' published in the December 29, 1995, issue of the Federal
Register (60 FR 67469).
Prior-Approval Requirements To Be Eliminated
A. Establishment Facilities
The demand for Federal inspection of sanitary conditions of
slaughterhouses was one of the principal concerns leading to enactment
of the 1906 Meat Inspection Act. Leading experts of the day in the
field of meat inspection advocated the approval of slaughterhouse plans
by qualified veterinary inspectors. Facilities for slaughtering,
dressing, and meat preparation that were properly designed and built
with sound materials that could be effectively cleaned and not
contaminate product were considered essential to help prevent the
spread of disease and protect the health and safety of the animal and
human populations. While the Meat Inspection Act itself did not mandate
prior approval of drawings as a condition of inspection, early
regulations issued under that law required the submission to the Agency
of plans for new and remodeled establishments for review and approval
before inspection could be granted.
The FMIA, the current law governing meat inspection, continues with
slight modification the provision in the original meat act assigning to
USDA the responsibility for regulating the sanitary conditions of
inspected establishments (see 21 U.S.C. 608). The PPIA contains similar
provisions, but neither of the Acts mandates prior approval of
establishment blueprints.
As a means of assuring sanitary conditions in inspected
establishments, the meat and poultry inspection regulations require
that applicants for inspection submit to FSIS the drawings and
specifications of establishments where inspected operations are to be
conducted for review and approval (9 CFR 304.2, 381.19). The
regulations also require that drawings reflecting any remodeling be
submitted in advance of construction (Secs. 308.2 and 381.18), and
prescribe specifications for facilities of inspected establishments (at
Secs. 307, 308, and 381, subparts G and H). This procedure was required
to help avoid costly changes in construction in the
[[Page 19580]]
event that FSIS determined facilities could create insanitary
conditions that could lead to food adulteration.
To comply with the prior-approval regulations, the applicant
completes a request form and provides a blueprint with specifications
to the FSIS inspector-in-charge. The blueprint and specifications are
then reviewed by the inspection circuit supervisor, the first level of
supervision outside inspected establishments, and sent directly to FSIS
headquarters in Washington, D.C. FSIS's area office--the second level
of supervision in the field organizational structure, which stands
between the circuit supervisors and the five Regional Offices--may also
review plans referred to it by the circuit supervisor before sending
them on to FSIS headquarters. In Washington, FSIS's facilities branch
reviews the information and decides whether to approve or reject the
drawings and specifications, seek further information, or return the
materials to the applicant. When changes are made in the facilities of
an establishment, the changes must be reflected in revised blueprints
for the establishment. The remodeled facilities are then reviewed by
the FSIS inspector-in-charge and the circuit supervisor to assure
compliance with the approved blueprints and that there will be no
product adulteration.
Currently, about 2,900 blueprints (both from new applicants and
from establishments remodeling their facilities) are reviewed each
fiscal year. About 38% of the submissions, or about 1,100 sets, are
rejected due to various deficiencies. Most rejections result from
errors in paperwork rather than design flaws that will compromise food
safety. The Agency works with the submitting establishments to see that
the deficiencies are corrected. Under prior approval, establishments
are urged to delay construction until drawings and specifications have
been approved, in order to avoid costly changes in construction or
remodeling.
Experience has shown that FSIS prior approvals are of limited value
in assuring good sanitation, because they are limited in both scope--
dealing only with establishment facilities as presented in drawings--
and time--they are given once, on the condition that establishments
will maintain a sanitary operating environment after their facilities
are approved. Ultimately, the establishments' implementation of good
sanitation operating procedures on a continuing basis is more critical
than the actual design of a facility. Also, with the elimination of
prior approval requirements, production time that previously was lost
in obtaining FSIS approval of blueprints and specifications would
become available to the industry.
Under the proposal, establishments would continue to be expected to
establish and maintain a sanitary environment for slaughtering and
processing by adhering to the general principles and requirements for
lighting, ventilation, drainage, plumbing, toilets, and condensation
found in Secs. 308.3(a)-(c), 308.4, 308.7, 308.8 (a) and (b), 381.46,
and 381.47 of the meat and poultry inspection regulations.
All official establishments (about 6,200 establishments), would be
affected by the proposal, except food irradiation facilities. There is
no requirement for prior approval of blueprints for food irradiation
facilities, because only prepackaged product is permitted to be
irradiated under current regulations.
Although FSIS's prior-approval procedures for drawings and
specifications would change under the proposal, its sanitation
standards would not. Establishments would be responsible for ensuring
that the design of facilities creates a sanitary environment and that
such an environment can be and is maintained. If field inspectors
carrying out their routine inspection tasks found product to be
adulterated or prepared, packed, or held under insanitary conditions
whereby it may have been contaminated with filth or may have been
rendered injurious to health because of deficient facilities, all
product subject to such conditions would be either retained and
reworked or condemned, and the establishment would be required to take
corrective action or cease operations. As under current regulations,
such corrective action, which might involve repair or reconstruction of
facilities, would be triggered only by an actual finding of product
adulteration or insanitary conditions. Such a finding would constitute
evidence of deviation from regulatory standards. Therefore, FSIS is
proposing to remove the current requirements for prior approval of
facility drawings and specifications. Requirements at 9 CFR 304.2(a),
308.2, and 381.19(a)-(f) for submission of blueprints and drawings
before inspection can be granted or changes made in facilities at
official establishments would be eliminated. Establishments would
initiate and complete construction without prior approval by FSIS.
Although there would no longer be a requirement for an
establishment to submit facility drawings and specifications in
applying for a grant of Federal inspection, FSIS would continue to have
a specific process through which the decision on granting inspection
would be made. This process would still include an on-site review, or
``walk-through,'' of the establishment's facilities by the FSIS circuit
supervisor as part of the predecisional review of the establishment's
capability to produce ``complying'' product. However, the
decisionmaking process would no longer include the review and prior
approval of establishment facility blueprints and specifications by the
Agency. The on-site review would not involve matching items on the
blueprints with the actual facilities represented. Instead, the focus
of the review would be on the extent to which the establishment is able
to maintain a sanitary environment for food production. This change
would be intended to parallel other changes in establishment-inspector
relationships that FSIS is contemplating in its reinvention of meat and
poultry inspection.
If this proposal is adopted, FSIS would plan to:
(1) maintain a small number of personnel who would assist
inspectors in performing in their in-plant roles. These roles would
eventually include the monitoring of establishment-operated sanitation
SOP's and HACCP systems;
(2) provide general guidance regarding establishment layout and
design to assist establishments in meeting food safety standards; and,
(3) publish one final edition of Agriculture Handbook 570, ``U.S.
Inspected Meat and Poultry Packing Establishments: A Guide to
Construction and Layout'', 1 and make it available to industry as
a guidebook to construction of facilities. Handbook 570, an FSIS
reference guide (not a set of regulatory requirements per se), is
provided to assist industry, architects, and inspectors.
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\1\ A copy of Agriculture Handbook 570 is on file for review in
the FSIS Docket Clerk's office, 4352 South Agriculture Building,
Washington DC, 20250.
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A small staff in Washington would maintain FSIS's technical
expertise and capability in this important aspect of food science and
technology. This staff would be responsible for keeping abreast of
developments in the field and updating FSIS's new, HACCP-oriented
guidelines and communicating technical information to Agency personnel.
The Agency will not approve industry decisions in these areas.
In addition, implementation of the proposed Pathogen Reduction/
HACCP rule's sanitation standard operating procedures, would render
prior-approval procedures unnecessary.
[[Page 19581]]
Establishment-operated sanitation procedures and HACCP systems would
accomplish, without prior approval, the same objectives as the FSIS
prior approvals. Thus, under HACCP-based inspection, the FSIS prior
approvals could no longer be considered an efficient and cost-effective
way to achieve sanitation objectives.
B. Equipment Approval
As in the case of the facilities regulations, the regulations
governing equipment (9 CFR 308.5, 381.53) were promulgated with a view
to having the Agency assure sanitation in slaughtering, dressing, and
processing operations. Requirements for sanitary equipment and utensils
have been in force since the 1906 Meat Inspection Act. However, unlike
prior approval of facility blueprints and drawings, the approval of
types of equipment prior to use has not always been a requirement.
Under regulations that have been in force since 1975 (9 CFR 308.5,
and 381.53), the FSIS Equipment Branch formally evaluates equipment and
utensils proposed by manufacturers or suppliers before they can be used
in official establishments to assure they can be maintained in a
sanitary condition. The program focuses on identifying and correcting
problems during the initial development of equipment, instead of
resolving problems after equipment is put into widespread use.
FSIS's acceptance of new, modified, or reconditioned equipment for
use in federally inspected meat and poultry establishments is a two-
step process. First, FSIS Equipment Branch personnel evaluate the
design and construction of equipment by reviewing assembly-type
drawings and corresponding parts and material lists submitted to the
Branch by the equipment manufacturer. Then, if necessary, FSIS
inspectors review the in-establishment operation of the equipment and
report their findings to the Equipment Branch. Commercially available
equipment is accepted and listed in an FSIS reference guide, ``Accepted
Meat and Poultry Equipment,'' \1\ known as the FSIS Equipment Book.
Once equipment is listed in this reference as acceptable, no further
approval is needed on an establishment-by-establishment basis. Certain
categories of equipment, such as simple tools and cleaning equipment,
are exempt from prior approval. Among the types of equipment that are
evaluated through FSIS's prior-approval procedure are clean-in-place
systems, piping used with establishment machinery, automatic
eviscerators, heat exchangers, smokehouses and ovens, air compressors,
and water recycling equipment.
FSIS processes about 2,500 equipment applications, rejections, and
acceptances each year. About 200 equipment applications are rejected on
first review for lack of sufficient information. About 650 acceptance
decisions are based on the results of in-plant trials. About 18
equipment applications are rejected after in-plant trials reveal
deficiencies.
The principal cost of the prior-approval process to the private
sector is considered to be that resulting from lost or delayed
equipment sales caused by delay in obtaining approval. This cost falls
mainly on equipment sellers and manufacturers and can be considerable
if the introduction of promising new technology is delayed. The
productivity of meat and poultry establishments could also be adversely
affected by delays in approving efficient new equipment.
Furthermore, FSIS's one-time approval does not address daily
operational issues such as proper maintenance and adjustment of
equipment to prevent product contamination. Such issues are covered by
the requirement that equipment and utensils be of such material and
construction that they can be easily cleaned to prevent product
adulteration (9 CFR 308.5, 381 subpart H), as well as by other general
requirements, independently of any prior approval.
The prior-approval review for equipment may sometimes involve the
evaluation of machinery, including scientific instrumentation, that
will not itself have contact with a food product or have other direct
effects on health or safety, but that may be part of an innovative
approach to food processing or product safety. The Agency's review may
delay testing or introduction of the innovation by weeks or months. The
delay can be costly to a company in a highly competitive environment.
FSIS is therefore proposing to eliminate the requirement at 9 CFR
308.5 and 381.53 for prior evaluation and approval of equipment and
utensils used in official meat and poultry establishments. The general
principles and requirements for such equipment and utensils provided at
9 CFR 308.5(a) and 381.53(a) would be preserved.
Under this proposal, equipment and utensils would still have to be
constructed so as to facilitate thorough cleaning and operational
cleanliness and not adulterate edible product. Also, they would still
have to be constructed, maintained, and used in a manner that does not
interfere with inspection.
However, FSIS would no longer conduct its acceptance program before
equipment could be used in an official establishment. Establishments
would be able to use equipment based on their own evaluation of their
ability to utilize the equipment in a sanitary way. The general
requirements for equipment already in the regulations (9 CFR 308.5 and
381.53) would not change. In its inspection activities, FSIS would
continue to judge establishment equipment by those same general
standards. Equipment must be cleanable, it must be capable of being
disassembled and inspected, and it must not interfere with inspection
or adulterate product. FSIS inspectors would continue to reject
equipment they find posing a sanitary hazard.
For calendar year 1996, the Agency will separate the general
guidance material from its list of approved equipment and publish the
guidance material separately. The final edition of the equipment list,
which FSIS published in 1995, is available to current subscribers and
to anyone who requests a copy before the effective date of the final
rule.
Operational procedures and appropriate sanitation process controls
would be developed by the inspected establishment. In this area, as in
facilities, official establishments would be required to meet the
general requirements prescribed in the regulations, but would be
allowed the flexibility to determine the specific steps to be taken to
comply with those requirements. The sanitation SOP's proposed for
official establishments in FSIS's Pathogen Reduction/HACCP proposal
would provide plans for applying the general principles for maintaining
sanitary conditions to specific establishment situations. The
establishment would also be required to maintain any controls
appropriate to the HACCP plans for the establishment's products (e.g.,
raw beef), such as making sure the facilities and equipment (structures
and machinery for evisceration) are designed, built, and operated so
that any necessary action (sanitary dressing procedures) can be taken
at critical control points in the HACCP plan.
The equipment prior-approval process proposed here for elimination
is to be distinguished from the program, announced by FSIS last year,
for reviewing experimentation with new technologies (``Guidelines for
Preparing and Submitting Experimental Protocols for In-Plant Trials of
New Technologies and Procedures; 60 FR 27714; May 25, 1995) under
commercial conditions. The purpose of the new program is to
[[Page 19582]]
encourage the adoption by industry of innovative technologies that will
help reduce the risk of foodborne disease. The Agency has established
procedures (see FSIS Directive 10,700.1) for reviewing protocols for
experimentation with new technologies in official establishments if
there is a possibility the experimentation could adversely affect
product, environmental, or worker safety, or interfere with inspection.
For example, in experiments involving the artificial contamination
of carcasses with fecal matter to test the effectiveness of a carcass
cleaning process, any products from these carcasses must be removed
from commercial channels or reconditioned to be wholesome or fit for
sale. Protocols for experiments involving the use of materials that
could pollute the environment or affect worker safety must include
appropriate regulatory citations or be accompanied by written approval
of the Environmental Protection Agency or the Occupational Safety and
Health Administration. Although new technologies can be expected to
include the use of equipment, the FSIS review program is primarily
intended to enable the experimentation to proceed rather than to
approve the equipment used.
Further Regulatory Reform
As stated in FSIS Docket #95-008A, ``FSIS Agenda for Change;
Regulatory Review'' (60 FR 67469; December 29, 1995), FSIS is reviewing
all of its regulations, policies, and inspection procedures, including
those concerning establishment sanitation (as presented in handbooks,
notices, directives, etc.). Although implementation of FSIS's proposal
for sanitation SOP's would not depend on revisions to the Agency's
sanitation regulations, because this is an area where inspectors have
traditionally exercised discretion and provided direct oversight and
direction to establishments, the Agency recognizes the need to more
clearly state its performance standards in this area. The Agency
believes that the regulations can be made much clearer in describing
the establishments' responsibilities, that doing so will relieve
inspectors of much of the routine work they do that should be done by
establishment employees, and that inspection resources can then be
freed up and reapplied in performing new, HACCP-related food safety
functions.
C. Partial Quality Control Programs
Quality control, in general, is a planned, documented system of
activities intended to assure the stability of processes and uniformity
of products. Quality control programs are based on the assumption that
there is normal variation in any process and that the process is under
control if that variation is not exceeded. Quality control is used in
manufacturing to assure that components and products from ball bearings
to microcomputer circuits, which are made in huge quantities, will all
have the same desired characteristics. In the food industry, quality
control systems are used in processing operations to make sure that
each product produced, from TV dinners to hotdogs, will be exactly the
same--will have the same content, flavor, color, texture, and so forth,
no matter how many thousands are made in a production run.
In applications relevant to food safety, quality control programs
can be used to maintain normal process variation around a standard,
such as a time-temperature standard for cooked beef or a moisture-
protein ratio for dry sausage. If the expected variation is exceeded,
corrective action must be taken to restore process stability and ensure
food safety.
Under current FSIS regulations, a company may choose to place all
of the processes and products in an establishment under a comprehensive
quality control system. Such a system, known as total quality control
(TQC), integrates an establishment's quality development, maintenance,
and improvement efforts to enable engineering, production, marketing,
and service to take place at the most efficient levels that meet
consumer expectations. A quality control system for only one process or
product in an establishment is known as a partial quality control
system (PQC). The quality control systems are, in a sense, precursors
of the HACCP system FSIS envisions in that they are establishment-
operated process control systems.
In 1980, FSIS promulgated regulations establishing procedures for
meat and poultry establishments to follow in obtaining Agency approval
of their voluntary TQC and PQC systems. FSIS approved several thousand
PQC programs during the 1980's. Since 1990, FSIS has approved an
additional 4,000 PQC programs and more than 3,000 amendments to those
programs. There are now more than 8,200 approved PQC programs.
An approved quality control program is typically a voluntary
activity in which an establishment is allowed to establish its own
control procedures (provided these conform with the regulations).
Approved PQC programs have provided FSIS with a tool or method for
maintaining assurances that label claims, composition declarations, and
many other standards are met, and that food products are safe. They
also allow FSIS to regulate processes for which specific criteria have
not been prescribed by the regulations. Verification inspection of the
PQC programs enables FSIS to determine whether or not the programs are
functioning. If they are shown to be malfunctioning, the establishment
takes corrective action.
There are several types of FSIS-approved PQC programs; most are
voluntary, some are mandatory. Voluntary PQC's generally fit into two
broad categories. The first type includes those that need not be used
to produce a product. For example, an approved PQC program for
controlling the percentage of fat and water in a product is not
necessary for an establishment to be allowed to make hotdogs. The
establishment could produce the product without the PQC program.
However, the PQC program helps assure that the establishment produces
the hotdog and other products in accordance with the regulatory
standards. Without a PQC program, an establishment runs a higher risk
of producing noncompliant product subject to retention by the FSIS
inspector.
The second type of voluntary PQC includes product labeling-related
programs intended to ensure production of a product that is in
compliance with a compositional requirement. For example, some PQC's
are designed to meet the requirements of vignette labeling (labeling
that shows an image of the food product either as it is in the
container or as served, such as labeling that shows a specific number
of meatballs in or pepperoni slices on a product); other PQC's are
designed to comply with product composition requirements that must be
met if certain labeling is used (such as the protein-fat-free
requirement for a product labeled ``ham, water added'').
There are also mandatory PQC programs. Some are compulsory for
certain types of food processing or are required to produce certain
products; others are required for an establishment to operate under a
certain inspection system. For example, the PQC for on-line carcass
quality control is a mandatory component of the New Line Speeds (NELS)
poultry inspection system. FSIS also requires approved PQC programs for
the testing of new or not-previously-approved antimicrobial treatments
in slaughtering establishments (to monitor equipment and process
controls for experimental design and safety reasons); for product
[[Page 19583]]
identification and control during slaughter, dressing, and processing
to support labeling statements; and for monitoring chlorine
concentrations in product intended for export to Canada.
There are also PQC programs to control products for so-called
economic factors. These programs are intended to prevent the marketing
of products that are misbranded or that lack the quality or value that
the product standard imposes. These economic PQC's are intended to
serve two main purposes: (1) to take the place of lot inspection of
product (the sampling and testing of a shift's production for certain
characteristics) by the FSIS inspector; and (2) to assure that products
meet requirements associated with their labeling.
Establishments operating the first type of economic PQC generate
data that are subject to random verification by the FSIS inspector.
Examples of these include programs for net weight, fat and water in
frankfurters, and boneless meat (mainly for aesthetic defects). An
establishment operating under a PQC for net weight keeps records of its
checks and corrective actions to avoid lot inspection. Under PQC's for
fat and water in frankfurters, establishments keep ingredient records
by lot and results of laboratory tests for random verification by FSIS
inspectors. An establishment operating a PQC for boneless meat
inspections does its own on-line inspections and keeps records. The
FSIS inspector randomly selects samples of product the establishment
has already inspected to assure that the establishment's records are
accurate.
Examples of the second kind of economic PQC include those for
controlling the amount of added ingredients in corned beef, the amount
of basting or marinating solutions in certain poultry products, and the
truthfulness or accuracy of certain label claims. The PQC programs for
basting or marinating solutions in certain poultry products assure that
the amount of added solution in such products does not exceed the
standards set forth in 9 CFR 381.169. The establishment accomplishes
the objective of these programs by controlling the pumping procedure at
the time of product formulation.
The PQC program for an establishment making a product bearing a
label claim that only sirloin cuts have been used in the meat portion
of the product must include an approved procedure with records for
assuring the veracity of the claim. The PQC's for vignette labeling
assure that product characteristics conform with the graphic display on
the product label, in accordance with 9 CFR 317.8(a) and 381.121. If a
product label shows four meat balls, the PQC for the product would have
to document that each package contains four meat balls. The programs
are carried out through in-plant sampling and visual inspection, with
verification checks by FSIS inspectors.
Although about 70 percent of PQC's are intended to support labeling
claims, not all have this purpose. Some support alternative processing
procedures that have become so routine that very specific guidelines
are followed in preparing the PQC program. FSIS has developed 64
guidelines detailing the essential elements of the most commonly used
PQC programs. Many of these are procedures that substitute for more
direct controls on economic or quality features of products such as
declared count, vignette labeling, or the ``popping'' of pork rinds.
These are not connected with food safety.
Under the current system, no matter how routine the preparation,
review, and subsequent approval of the PQC program, each must be
submitted to either the Washington office or a Regional Office and be
stamped ``approved.'' FSIS has assigned 11 staff-years to the review
and approval of establishment PQC programs. Approximately 1,800 quality
control programs and amendments are handled each year by the Regional
Offices; approximately 50 programs for complex processes or requiring
specialized knowledge (such as programs for thermal processing) are
approved each year by the Washington office. The purpose of the review
is to assure that the programs contain all the necessary elements of a
quality control program and are appropriate for their intended purpose.
The programs must describe the product and process for which they are
intended, and the materials to be used. They must identify any hazards,
define process deviations, indicate the control points to be monitored,
and procedures for checking processes. They must also state the methods
for gathering data and determining results, and the corrective actions
to be taken if process deviations are found. Finally, the programs must
bear the names and locations of responsible establishment quality
control officials and authorized USDA employees must have access to
records generated by the programs. The time for a PQC prior approval to
be obtained is typically 2 weeks.
FSIS considers this administrative burden on the industry and the
Agency to be unnecessary to achieve food safety or nonadulteration
objectives. Under HACCP-based inspection, establishments would assume
responsibility for developing process control procedures in advance
without having to depend on Agency approval for every step in their
procedures. FSIS would evaluate or verify the effectiveness of the
procedures through normal inspection operations and take action when
necessary to prevent product adulteration.
By relying on general requirements for the design of all PQC
programs, but not requiring prior approval of such programs, FSIS could
use its resources (staff-years) more efficiently and effectively than
it does now in its PQC prior-approval activities. This approach would
also provide establishments with ample flexibility to develop their own
process control techniques.
For these reasons, FSIS is proposing to eliminate the requirements
at 9 CFR 318.4(d) and 381.145(d) for prior approval of PQC programs.
Prior approval of most voluntary or ``economic'' PQC programs would be
discontinued and an unnecessary regulatory burden would thus be lifted.
However, the current requirements governing the content of PQC programs
would remain (Secs. 318.4(d)(2)(i) and 381.145(d)(2)(i)), as would
existing mandatory-PQC requirements. Prior approval of PQC programs
would be eliminated for all but a few of the mandatory PQC programs,
such as those required for certain slaughter inspection systems, or
those requiring special expertise, such as PQC's for thermal processing
or other complex processing. The Agency, however, is planning to change
these areas of its regulations to eliminate prior reviews and make them
compatible with HACCP. This proposal would eliminate at least 90
percent of the approximately 1,900 PQC submissions made to FSIS each
year. Cross-references to the existing prior-approval requirement would
also be eliminated (in 9 CFR 318.7(b)(3), 318.7(c)(4), 317.21, 318.19,
318.309, 319.5, 319.104, 381.121d, and 381.309).
In addition, the regulations would be revised to provide (in 9 CFR
318.4(d)(2)(ii) and 381.145(d)(2)(ii)) for the design of PQC programs
to assure, with at least 85 percent statistical confidence, that the
lot or process means do not exceed the product or label limits to which
the PQC programs apply. This requirement, which is already observed in
the design of FSIS-approved PQC programs now in use, would also provide
for control of individual sublot samples to within plus-or-minus 3
standard errors (standard deviations of the sampling distribution) of
the process mean. At least 3 sublot samples representing a
[[Page 19584]]
production lot would have to be drawn for each lot of product subject
to the PQC program. Further, each sublot sample would have to contain
at least 5 samples representing the sublot. No individual sample mean
or sublot-sample mean could be more than 3 standard errors above or
below the process mean. (A lot is ordinarily a shift's production, but
may be defined differently by different establishments. A sublot is a
fraction of a lot, and may represent an hour's production, or a
quarter-hour's production, or other portion of a production lot from
which quality control samples may be drawn.)
For example, a PQC program prepared according to the FSIS guideline
for the injection of corned beef labeled as having 30-percent added
solution would be designed to assure with greater than 85 percent
confidence that the 30-percent limit is not exceeded. In other words,
the lot average must not be above this limit. A batch, a portion of the
lot, must not be more than 1.2 percent above the declared value on the
label. Samples drawn from individual batches of the production lot
would have to show that the 3-standard-errors limit (in this example,
1.2 percent, or 31.2 percent added solution) is not exceeded.
PQC programs thus designed would provide process control, and hence
a degree of food safety or food nonadulteration assurance, that is
comparable to that provided currently by PQC programs individually
approved by FSIS. Official establishments would have a less
prescriptive set of conditions to meet in designing and implementing
their PQC programs, and more latitude for innovation. Because the
unnecessary regulatory burden of prior approval would no longer exist,
establishments would be able to implement their programs sooner than
the current prior-approval process allows.
Establishments would be required to comply with the requirements in
proposed 9 CFR 318.4(d)(2)(ii) and 381.145(d)(2)(ii) in designing their
PQC programs. Prior approval would still be required for quality
control programs and systems referred to elsewhere in the regulations
(e.g., 9 CFR 318.4 (c), (e), (f), and (h); and 381.145 (c), (e), (f),
and (h)), including those associated with, and required for, such
slaughter inspection systems as the NELS and the NTIS (9 CFR
381.76(c)). Proposals addressing these programs and systems will be
published in the near future. This proposed rule would amend paragraphs
9 CFR 318.4(e) and 381.145(e) to delete references to prior approval
requirements for PQC programs.
Proposed 9 CFR 318.4(d)(1) and 381.145(d)(1) would retain the
current requirement for official establishments with PQC's to make the
programs and data and information generated by them available to FSIS
inspectors. Formal notification would not be required because
establishment operators typically notify FSIS personnel of the products
and processes operated under establishment-operated PQC programs during
their regular interactions with FSIS personnel. Establishment operators
recognize the advantage of making their quality control programs and
data available to FSIS. FSIS personnel who have not been advised that a
product is being produced under a PQC program would perform traditional
lot inspection procedures, rather than quality control evaluation and
verification tasks. The results of lot inspection may differ
technically from those obtained under a PQC inspection. A product lot
could be subject to retention even though the process for the product
is under control, requiring no corrective action to restore controls.
FSIS, therefore, is not proposing to terminate the use of PQC's as
a mechanism for organizing the collection and review of data which
document outcomes. FSIS is, however, proposing to end its role as the
approver of paperwork describing data collection to support alternative
processing procedures.
Establishments operating under approved PQC programs would continue
to keep the programs on file and available for use by FSIS employees.
FSIS would adjust verification inspection tasks to reflect an approach
that is appropriate to the process control procedure being used by the
establishment.
It is likely that establishments will find the continued use of PQC
programs to be advantageous under the inspection system envisioned by
the Agency in its ``Pathogen Reduction/HACCP'' proposal. Although most
PQC programs currently used by inspected establishments control
products and processes for economic factors, e.g., fat and moisture
content or the amount of marinating solution a product can absorb,
there are some that have public health implications. Such PQC programs
would be compatible with establishment-operated HACCP plans and
establishments would continue to use them under HACCP-oriented
inspection. Moreover, because establishments operating HACCP plans
would be concerned about maintaining stability in all their processes,
they would be likely to continue many of their economic PQC's or
develop new ones. But they would no longer need prior approval from
FSIS before implementing them.
FSIS considers relief from the prior-approval aspect of these PQC's
to be the first in a series of steps to realign inspection and company
responsibilities in the area of process control systems. As FSIS
progresses in its review and adjustment of its inspection regulations,
it will take more steps in this area. Regulations will be rewritten as
performance standards, facilitating innovation. Establishments will be
free to develop establishment-specific approaches as long as the
regulatory objectives are met. Therefore, as FSIS reinvents its
regulations in accordance with its stated plans (see docket #95-008A,
``FSIS Agenda for Change; Regulatory Review''), the need for Agency-
developed guidelines should decrease. Companies will be able to call on
a full range of technical resources to develop alternatives and design
systems to demonstrate their efficacy.
Other Prior Approvals
This proposal addresses the removal of the requirements for prior
approval of facility blueprints, equipment, and PQC programs for
inspected meat and poultry establishments. In addition to the prior
approvals discussed in this proposal, FSIS plans to eliminate its
remaining centralized prior approval procedures. These include the
procedures for: PQC's for water reuse, on-line PQC's used in the NELS
and NTIS poultry inspection systems, nonfood compounds and proprietary
additives, and possibly labeling. FSIS intends to publish proposals on
these topics in the near future.
Like the regulations governing meat and poultry inspection, the egg
products inspection regulations, promulgated under the Egg Products
Inspection Act (21 U.S.C. 1031, et seq.) (EPIA), also contain prior-
approval procedures for facilities and blueprints (7 CFR 59.146,
59.500, 59.506, 59.520, 59.538, 59.540, and 59.550), labels (7 CFR
59.411), equipment and utensils (7 CFR 59.502, 59.506, 59.515, 59.520,
59.522, 59.540, 59.540, 59.547, and 59.552), nonfood compounds (7 CFR
59.504 and 59.552), and various processing procedures for egg products.
FSIS is not prepared to propose to remove these requirements because
FSIS has only recently acquired responsibility for administering the
EPIA and the egg products inspection regulations promulgated under that
Act. FSIS has just begun reviewing the prior-approval requirements in
the egg products regulations to see which, if any, are still necessary
and should be maintained, and which are obsolete or burdensome and
should be amended or
[[Page 19585]]
rescinded. As appropriate, FSIS will propose changes in the egg
products inspection regulations.
Executive Order 12778
This proposed rule has been reviewed under Executive Order 12778,
Civil Justice Reform. States and local jurisdictions are preempted
under 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 poultry products that are
in addition to, or different than, those imposed under the FMIA or
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
and poultry products that are misbranded or adulterated under the FMIA
or PPIA or, in the case of imported articles, which are not at such an
establishment after their entry into the United States.
This proposed rule is not intended to have retroactive effect.
If this proposed rule is adopted, administrative proceedings will
not be required before parties may file suit in court challenging this
rule. However, the administrative procedures specified in 9 CFR
Secs. 306.5 and 381.35 must be exhausted prior to any judicial
challenge of the application of the provisions of this rule, if the
challenge involves any decision of an FSIS employee relating to
inspection services provided under the FMIA or PPIA.
Executive Order 12866 and Effect on Small Entities
This proposed rule has been determined to be significant and was
reviewed by OMB under Executive Order 12866.
FSIS is proposing to eliminate prior approval requirements for
establishment drawings and specifications, equipment, and certain
partial quality control programs. Concurrent with this proposal, FSIS
would restructure inspection activities to focus more attention on the
ability of establishments to maintain a sanitary environment. These
actions, in addition to implementation of the sanitary standard
operating procedures, which were proposed by the Agency as part of the
Pathogen Reduction/HACCP proposal, would provide the industry the
flexibility for creating and maintaining a sanitary working environment
without prescriptive command-and-control requirements.
Removing these requirements would affect establishments subject to
official inspection, firms producing and selling equipment currently
subject to prior approval, firms providing expediting services to
businesses seeking prior approval, and consumers. The proposal would
reduce demands on FSIS resources which could be redirected to functions
more critical to improving food safety.
Alternatives to this rulemaking that FSIS considered for facilities
and equipment prior approvals included development by FSIS of detailed
standards to be published in booklets with periodic updates,
recognizing industry organizations as prior approval authorities, and
establishing general performance standards similar to FDA-recognized
good manufacturing practices. Another alternative which would have
provided these services on a voluntary, user-fee basis, was considered
but not adopted. FSIS has chosen the option of eliminating prior
approval requirements while maintaining the general food safety
standards in the existing regulations.
For PQC prior approvals, the alternatives to no rulemaking were
market sampling of finished products, mandating additional in-plant
controls, sampling of finished products for chemical analysis, and
maintaining general requirements and a standard for the design of PQC
programs. The last option was chosen because it would provide official
establishments with the most flexibility in implementing PQC programs.
Benefits of the Rule
Approximately 6,200 federally inspected meat and poultry
establishments would no longer be required to submit blueprints,
drawings, and specifications to FSIS for review and approval. FSIS
reviewed about 2,900 submissions in FY 1994. The cost of receiving FSIS
approval for drawings and specifications and changes they represent
includes the administrative, mailing, and labor costs associated with
preparing the required Agency forms. The labor cost is estimated at 30
minutes for each submission. Assuming an hourly wage or per-hour salary
of $20-$25 for each person submitting blueprints and specifications and
the FSIS form, the annual cost to the industry for making these
submissions is in the range of $30,000 to $40,000. This, then, is an
estimate of the savings accruing to industry from removing the
requirement for prior approval that FSIS is proposing.
As many as 1,500 establishments per year submit for approval PQC
programs or amendments to PQC programs. FSIS receives a total of 1,900
submissions each year. A typical PQC program, prepared according to
FSIS guidelines, can be written up in about 4 hours by an individual
earning $20 to $25 per hour. Thus, removing the requirement for prior
approval of PQC plans is estimated to save the industry $150,000 to
$190,000 per year.
FSIS receives approximately 2,500 submissions for approval of
equipment each year. The costs of these applications generally fall on
equipment manufacturers rather than the meat and poultry firms subject
to inspection, although a few meat and poultry establishments make some
of their own equipment or equipment modifications. FSIS has no estimate
that specifically pertains to the costs to manufacturers of applying
for equipment approval, but these costs are assumed to be comparable to
the costs to official establishments of submitting blueprint and
establishment specification approvals. FSIS recognizes that actual
costs to firms seeking equipment approval may differ and welcomes
comments on this. Based on 30 minutes per submission, a labor cost of
$20-$25 per hour, and 2,500 submissions annually, the annual cost
savings from removing the prior approval requirement for equipment
would be in the range of $25,000 to $32,500. In addition, approximately
650 applications for approval are contingent on in-plant trials. These
trials involve some added costs to manufacturers and meat and poultry
establishments, but the Agency has no estimates of these costs to
include in this analysis. FSIS invites commenters to present
information indicating what these costs are.
The proposal to eliminate blueprint prior approvals would remove a
source of income for approximately 20 small firms that represent
official establishments for the purpose of labeling and blueprint
approval. These firms are known as ``expediters.'' It is estimated that
approximately 20 percent of the annual blueprint submissions (about
600) are made to the Agency using the services of expediters. The
estimated annual total value of blueprint expediting is about $240,000
for the companies involved. While this would be lost income to the
expediters, it would be a transfer to meat and poultry firms, which is
not a social cost of the proposed rule.
The social benefits directly resulting from the elimination of
prior approval requirements as proposed in this rulemaking are
indicated in Table 1. There would be additional but unquantifiable
social benefits from the proposals to eliminate prior approvals.
[[Page 19586]]
These benefits derive from efficiencies arising from fewer demands on
management, greater incentives to adopt innovative practices, and the
enhanced ability to make changes quickly which the prior approval
system and its inherent delays inhibit. Also, the delays inherent in
the prior approval process, which can be translated into lost
production time, would be eliminated.
However, it is unlikely that an inspection finding of adulterated
product or insanitary conditions under the amended regulations would
result in increased costs to the industry for rebuilding or remodeling
facilities. Establishments planning substantial investments in new
construction typically consult with local authorities and experts with
up-to-date knowledge of food establishment construction before
beginning major projects.
In addition to the benefits to firms from elimination of these
prior approval requirements, FSIS could be expected to benefit by
reallocating about $2.3 million to high priority food safety needs.
Currently, the Agency allocates about 15 staff-years ($750,000) to
reviews of equipment, 20 staff-years (about $1 million) to reviews of
drawings and specifications, and 11 staff-years ($550,000) to review
and approval of PQC programs. The true social benefits to be expected
are the improvements in food safety that would logically flow from
reallocating these resources to more important food safety-related
tasks.
Costs of the Proposed Rule
As is currently the practice, inspectors would continue to require
establishments to take corrective action or cease operations if any
product has been adulterated or prepared, packed or held under
insanitary conditions whereby it may have been contaminated with filth
or may have been rendered injurious to health, because of deficient
facilities and equipment. Corrective action, which might include
reconstruction, remodeling, and redesign would only be triggered by an
actual finding of product adulteration or insanitary conditions.
However, it is unlikely that this proposal will increase the level of
inspection findings that result in reconstruction, remodeling, and
redesign of facilities and equipment.
Currently, facility and equipment plans submitted to FSIS for prior
approval are rejected due either to errors in paperwork or to deviation
from specific design criteria developed by FSIS. Under the proposal,
establishments would not have to submit applications for approval.
Instead, establishments would be permitted to initiate and complete
construction or introduce new equipment without submitting any
paperwork to FSIS. In addition, FSIS would eliminate design-related
criteria currently utilized to evaluate the acceptability of facilities
and equipment. Inspectors would no longer require establishments to
incur costs for reconstruction, remodeling, and redesign, because the
actual facility or piece of equipment does not match a specified design
criterion, blueprint, or equipment specification.
In the absence of prior approval, FSIS would focus inspection on
whether establishments are maintaining a sanitary environment. Under
this proposal and the proposed rule on sanitation standard operating
procedures, establishments would assume greater control over their
production practices to ensure that a sanitary environment is
maintained. Currently, many establishments utilize the services of
knowledgeable architects, engineers, and other experts to design
facilities and equipment for use in meat and poultry establishments.
Under prior approval, these experts ensure, among other things, that
FSIS design specifications are met. Without prior approval,
establishments may require these experts to provide more information on
the procedures necessary for maintaining facilities and equipment in a
sanitary condition, which could increase the costs for these services.
However, this is consistent with the need for the industry to assume
greater responsibility for its operations. Any cost increases for these
services would be commensurate with the transfer of responsibility from
FSIS to the industry, and would not be a social cost attributable to
the rule.
Table 1.--Benefits to Firms From Eliminating Prior Approval Requirements
----------------------------------------------------------------------------------------------------------------
Firms with more than Firms with fewer
Action 500 employees than 500 employees All firms
----------------------------------------------------------------------------------------------------------------
Remove blueprint and specification approval... $1,800-$2,400 $28,200-$37,600 $30,000-$40,000
Remove equipment approval..................... $2,500-$3,250 $22,500-$29,250 $25,000-$32,500
Remove PQC approval........................... $9,000-$11,400 $141,000-$178,600 $150,000-$190,000
-----------------------------------------------------------------
Total................................... $13,300-17,050 $191,700-$245,450 $205,000-262,500
----------------------------------------------------------------------------------------------------------------
Regulatory Flexibility Assessment
The Administrator has determined that, for the purposes of the
Regulatory Flexibility Act (5 U.S.C. 601-12), this proposed rule would
not have a significant economic impact on a substantial number of small
entities. The entities that would be affected by this proposal are
inspected meat and poultry establishments, equipment suppliers, and
companies representing official establishments to the Agency for the
purpose of obtaining blueprint approvals. Most of these are small
entities.
The proposed rule is expected to have a beneficial effect on small
and large entities, on both those regulated under the FMIA and PPIA and
some that are not regulated under the inspection laws but which are
affected by the Agency's review of their products, e.g., suppliers of
equipment used in inspected meat and poultry establishments.
There are about 5,800 federally inspected small establishments. In
this analysis, FSIS is using the Small Business Administration (SBA)
business size standards (at 13 CFR 121.601) for meat packing
establishments, establishments that produce sausages and other prepared
meats, and poultry slaughtering and processing establishments. A small
establishment in any of these categories is considered to be one with
500 or fewer employees. Under current regulations, all official
establishments are required, as a condition of receiving inspection
services, to submit blueprints, drawings, and specifications of new or
remodeled facilities to FSIS for review and approval. Under this
proposal, the establishments would, of course, not be spared the cost
of preparing for themselves blueprints and specifications for
construction and major installations. However, they would no longer
bear the cost of submitting these drawings and specifications to the
Agency for review
[[Page 19587]]
because the requirement to do so would be eliminated.
The savings to be obtained by eliminating FSIS approval for
drawings and specifications and the changes they represent includes the
administrative and mailing costs and the time (resources) required to
fill out the required Agency form (``Submission and Approval of Plans
and Specifications,'' FSIS -5200-S), which is estimated at 30 minutes
each submission. As mentioned above, the annual savings to the meat and
poultry products industry from eliminating the requirement of making
the submissions would be in the neighborhood of $30,000-40,000. FSIS
does not consider this savings to be significant. But in addition to
such direct savings, the largest potential savings to the industry
resulting from the prior approval process for blueprints and
specifications would be those associated with the elimination of
delays--of up to several weeks per submission--in obtaining approval.
This estimated delay includes the time needed to resolve disagreements
over plans and specifications, should such disagreements arise between
the Agency and the establishment. This savings could be significant for
some small entities, but there is no information to indicate that it
would be so for a substantial number of them.
The savings would not be significant for at least two reasons.
First, establishments engaged in construction projects plan for the
eventuality of an FSIS review, or at least are advised by knowledgeable
food establishment architects and engineers to build FSIS review time
into their project timelines. Costs are minimized because delays that
do occur are anticipated. Second, under the current prior review and
approval system, the Agency is able to exercise discretion expediting
reviews of blueprints and facilities in specific cases to prevent
economic hardship from occurring. The proposal is intended to eliminate
the costs attributable to the delays associated with prior review and
approval.
While eliminating the cost of blueprint prior approvals to small
establishments producing meat and poultry products, the proposal would
at the same time remove a source of income for about 20 small
expediting firms that represent official establishments for the purpose
of labeling and blueprint approvals. These expediters are frequently
able to shorten the time for these approvals and reduce the rejection
rate on submissions because of their knowledge of Agency requirements
and proximity to Agency offices. As mentioned above, the estimated
annual total value of blueprint expediting is about $240,000 for the
companies involved. This is a small part of the expediters' total
business, which is mainly that of expediting label approvals and
consulting work. These 20 entities, in any event, do not constitute a
substantial number of small entities unfavorably affected by this rule.
By the same reasoning that the Agency used to determine that these
prior approvals do not serve to increase the safety of meat and poultry
products, the expediting activities of these firms that will be reduced
by the rule would no longer be a productive use of resources. These
firms may, however, experience an increased demand for their consulting
services from inspected establishments who depended upon the
Government's prior approval to assure they were in compliance with the
regulations, who now need help from a third party to assure they are in
compliance with the regulations.
The equipment acceptance procedure principally affects
manufacturers or other vendors of equipment. The equipment
manufacturers range in size from small to large concerns and, under the
current regulations, depend on FSIS prior approval to be able to sell
their products to inspected establishments. It is estimated that up to
90 percent of the equipment manufacturers and other applicants for FSIS
equipment acceptance are small entities. According to the SBA business
size standards (13 CFR 121.601), a small food products machinery
manufacturer is one that employs 500 or fewer people.
Also favorably affected by the approval process are inspected
establishments that may require machinery or other equipment to improve
or continue their operations. As is the case in the blueprint review
process for inspected facilities, the savings from avoiding a delay
before installation and operation of a newly developed piece of
equipment, although it could be significant for a few entities, large
or small, but will not be significant for most establishments.
Finally, FSIS has determined that the proposal to eliminate prior
approval of most voluntary PQC programs would not have a significant
economic impact on a substantial number of small entities. Both large
and small establishments subject to FSIS inspection would be permitted
to continue to develop and implement PQC programs for their products
and processes but would no longer be required to submit the PQC's to
FSIS for review and approval in advance of use. Accordingly, the
administrative delay for review that occurs under the present system
would be eliminated.
It takes a minimum of 2 weeks for the Agency to review a typical
PQC program, and as many as 1,500 establishments per year submit such
programs or amendments to programs--a total of nearly 1,900 submissions
per year--and about 90 percent of these establishments could be
regarded as small entities. Therefore, roughly 1,100 establishments
would avoid the costs associated with having to wait a minimum of 2
weeks for PQC approval, but it is not possible to identify what costs
would be saved under these circumstances.
For these reasons, the Administrator has determined that this
proposal would not result in a significant economic impact on a
substantial number of small entities. The economic impact on such
entities would in most cases involve the elimination of certain costs--
some quantifiable, some not quantifiable--associated with doing
business subject to Federal regulation and hence would be beneficial to
those entities. Though non-quantifiable, increasing the benefits that
come from reducing an establishment's dependence on Government
decisions is an important objective of the proposed rule.
Paperwork Requirements
FSIS has reviewed the paperwork and recordkeeping requirements in
this proposed rule in accordance with the Paperwork Reduction Act. This
proposed rule would substantially reduce ``reporting'' requirements for
official establishments and other entities. FSIS estimates the total
reduction in reporting to be 4,291 burden hours. The reductions would
occur in the following information collection reports:
0583-0082, ``Meat and Poultry Inspection; Application for
Inspection, Sanitation, and Equipment Requirements and Exemptions'':
Establishments subject to inspection would no longer have to submit
blueprints and specifications along with Form FSIS-5200-5. The response
time is estimated to be 30 minutes, and there are 701 total burden
hours approved by the Office of Management and Budget (OMB) for this
activity. Therefore, FSIS would request OMB to remove the 701 approved
burden hours.
0583-0082, ``Meat and Poultry Inspection; Application for
Inspection, Sanitation, and Equipment Requirements and Exemptions'':
FSIS prior approval would no longer be required for the products of
these companies that are used in official establishments. The response
time is
[[Page 19588]]
estimated to be 30 minutes for the prior approval of equipment. There
are 2,990 total burden hours approved by OMB for this activity.
Therefore, FSIS would request OMB to remove the 2,990 approved burden
hours.
0583-0089, ``Processing Procedures and Quality Control
Systems'': Establishments could continue to develop and implement PQC
programs according to Agency guidelines. These establishments, with the
exception of poultry irradiation facilities, would no longer be
required to submit a letter requesting approval of a proposed PQC
program and a copy of the program to the Agency for approval prior to
implementation. The response time is estimated to be 30 minutes for
writing the request letter and sending the PQC program to FSIS. There
are 600 total burden hours approved by OMB for this activity. In
consideration of poultry irradiation facilities 60 hours of burden
would remain. FSIS does not foresee more than two irradiation
facilities requesting FSIS approval of PQC programs. Therefore, FSIS
would request OMB to remove 540 approved burden hours. The burden hours
for PQC program development and reporting would remain the same.
Copies of this information collection assessment can be obtained
from Lee Puricelli, Paperwork Specialist, Food Safety and Inspection
Service, USDA, South Agriculture Building, Room 3812, Washington, DC
20250.
Comments are invited on: (a) whether the proposed collection of
information is necessary for the proper performance of the functions of
the Agency, including whether the information will have practical
utility; (b) the accuracy of the Agency's estimate of the burden of the
proposed collection of information including the validity of the
methodology and assumptions used; (c) ways to enhance the quality,
utility, and clarity of the information to be collected; and (d) ways
to minimize the burden of the collection of information on those who
are to respond, including through the use of appropriate automated,
electronic, mechanical, or other technological collection techniques or
other forms of information technology. Comments may be sent to Lee
Puricelli, Paperwork Specialist (see address above), and to the Desk
Officer for Agriculture, Office of Information and Regulatory Affairs,
Office of Management and Budget, Washington, DC 20253.
Comments are requested by July 1, 1996. To be most effective,
comments should be sent to OMB within 30 days of the publication date
of this proposed rule.
List of Subjects
9 CFR 304
Drawings, Information to be furnished, Grant or refusal of
inspection, Meat inspection.
9 CFR 308
Meat inspection, Sanitation.
9 CFR 317
Meat inspection, Reporting and recordkeeping requirements.
9 CFR 318
Meat inspection, Establishment-operated quality control.
9 CFR 319
Food grades and standards, food labeling.
9 CFR 381
Poultry and poultry products.
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 304--APPLICATION FOR INSPECTION; GRANT OR REFUSAL OF
INSPECTION
1. The authority citation for Part 304 would be revised to read as
follows:
Authority: 21 U.S.C. 601-695; 7 CFR 2.18, 2.53.
2. The heading of section 304.2 would be revised to read as
follows:
Sec. 304.2 Information to be furnished; grant or refusal of
inspection.
* * * * *
3. Section 304.2 would be amended by removing paragraph (a) and
redesignating paragraphs (b) through (f) as paragraphs (a) through (e),
respectively.
PART 308--SANITATION
4. The authority citation for Part 308 would be revised to read as
follows:
Authority: 21 U.S.C. 601-695; 7 CFR 2.18, 2.53.
Sec. 308.2 [Removed]
5. Section 308.2 would be removed and reserved.
6. Section 308.5 would be amended by removing ``, in the judgment
of the Administrator,'' from the first and third sentences of paragraph
(a); removing paragraphs (b) through (f); redesignating paragraph (g)
as (b); and revising the section heading to read as follows:
Sec. 308.5 Equipment and utensils to be easily cleaned; those for
inedible products to be so marked; PCB-containing equipment.
* * * * *
PART 317--LABELING, MARKING DEVICES, AND CONTAINERS
7. 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.
8. Section 317.21 would be amended by removing the words ``or
Partial Quality Control Program'' from paragraph (b).
PART 318--ENTRY INTO OFFICIAL ESTABLISHMENTS; REINSPECTION AND
PREPARATION OF PRODUCTS
9. The authority citation for part 318 would be revised to read as
follows:
Authority: 7 U.S.C. 138f, 450, 1901-1906; 21 U.S.C. 601-695; 7
CFR 2.18, 2.53.
10. Paragraph (d) of Sec. 318.4 would be revised to read as
follows:
Sec. 318.4 Preparation of products to be officially supervised;
responsibilities of official establishments; plant operated quality
control.
* * * * *
(d) Partial Quality Control Programs. (1) Any owner or operator of
an official establishment preparing meat food products who is using a
quality control program for a product, operation, or part of an
operation shall make the written program and data and information
generated by the program available to Program employees.
(2) (i) Such quality control program shall include, as appropriate
for the product, operation, or part of an operation which the program
concerns, detailed information on: raw material control, the critical
check or control points, the nature and frequency of tests to be made,
the charts and records that will be used, the length of time such
charts and records will be maintained in the custody of the official
establishment, the limits which will be used and the points at which
corrective action will be taken to prevent recurrence of a loss of
control, and the nature of the corrective action--ranging from the
least to the most severe.
(ii) Such quality control program shall be designed so as to
provide, with at least 85 percent statistical confidence, that the lot
mean (process mean) is within the product or label limit used and that,
of a minimum of 3 sublot samples representing the lot, with each sublot
sample containing at least 5 samples representing the sublot, no
[[Page 19589]]
individual sample mean or sublot-sample mean shall be greater than
three standard errors above, nor less than three standard errors below,
the process mean.
* * * * *
11. Paragraph (e) of Sec. 318.4 would be amended by removing the
words ``or Partial Quality Control'' from the paragraph heading, the
words ``or (d)'' from the first sentence of paragraph (e)(1) and both
occurrences of the words ``or partial quality control program'' from
the second sentence of the same paragraph (e)(1); by removing the words
``or program'' from the first and second sentences of paragraph (e)(2);
by removing the words ``or partial quality control program'' from
paragraph (e)(3); and by revising the heading of paragraph (g) and
removing the words ``or partial quality control program'' from
paragraphs (g)(1) and the introductory text of (g)(2) and revising
paragraph (g)(3) to read as follows:
Sec. 318.4 Preparation of products to be officially supervised;
responsibilities of official establishments; establishment operated
quality control.
* * * * *
(g) Termination of Total Establishment Quality Control.
* * * * *
(3) If approval of the total establishment quality control system
has been terminated in accordance with the provisions of this section,
an application and request for approval of the same or a modified total
establishment quality control system will not be evaluated by the
Administrator for at least 6 months from the termination date.
* * * * *
12. Paragraphs (b)(3)(i) and (b)(3)(ii) of Sec. 318.7 would be
revised to read as follows:
Sec. 318.7 Approval of substances for use in the preparation of
products.
* * * * *
(b) * * *
(3) * * *
(i) 100 ppm ingoing (potassium nitrite at 123 ppm ingoing); and 500
ppm sodium ascorbate or sodium erythorbate (isoascorbate) shall be
used; provided that the establishment has a partial quality control
program as provided in Sec. 318.4(d) such as to result in compliance
with this provision, or
(ii) A predetermined level between 40 and 80 ppm (potassium nitrite
at a level between 49 and 99 ppm); 550 ppm sodium ascorbate or sodium
erythorbate (isoascorbate); and additional sucrose or other similar
fermentable carbohydrate at a minimum of 0.7 percent and an inoculum of
lactic acid producing bacteria such as Pediococcus acetolactii or other
bacteria demonstrated to be equally effective in preventing the growth
of botulinum toxin at a level sufficient for the purpose of preventing
the growth of botulinum toxin; provided that the establishment has a
partial quality control program as provided in Sec. 318.4(d) such as to
result in compliance with this provision.
* * * * *
13. In the table in Sec. 318.7(c)(4) under the Class of substance
``Miscellaneous,'' the entry under the Substance ``Ascorbic Acid,
erythorbic acid, citric acid, sodium ascorbate, and sodium citrate''
would be revised to read as follows:
Sec. 318.7 Approval of substances for use in the preparation of
products.
* * * * *
(c) * * *
(4) * * *
----------------------------------------------------------------------------------------------------------------
Class of substance Substance Purpose Product Amount
----------------------------------------------------------------------------------------------------------------
* * * * * *
Miscellaneous................ Ascorbic acid, To delay Fresh beef Not to exceed, singly or in
erythorbic discoloration. cuts, fresh combination, 500 ppm or 1.8
acid, citric lamb cuts, and mg/sq inch of product surface
acid, sodium fresh pork of ascorbic acid (in
ascorbate and cuts. accordance with 21 CFR
sodium 182.3013), erythorbic acid
citrate, (in accordance with 21 CFR
singly or in 182.3041), or sodium
combination ascorbate (in accordance with
under quality 21 CFR 182.3731); and/or not
control. to exceed, singly or in
combination, 250 ppm or 0.9
mg/sq inch of product surface
of citric acid (in accordance
with 21 CFR 182.6033), or
sodium citrate (in accordance
with 21 CFR 182.6751).
* * * * * *
*
----------------------------------------------------------------------------------------------------------------
14. Section 318.19 would be amended by removing the words ``or
partial quality control program'' from paragraph (e).
15. Paragraph (a) of Sec. 318.309 would be amended by removing the
words ``an approved'' and ``program'' and paragraphs (b) and (c) of
Sec. 318.309 would be amended by removing ``and submitted to the
Administrator for approval''.
PART 319--DEFINITIONS AND STANDARDS OF IDENTITY OR COMPOSITION
16. The authority citation for Part 319 would continue to read as
follows:
Authority: 7 U.S.C. 450, 1901-1906; 21 U.S.C. 601-695; 7 CFR
2.18, 2.53.
17. Section 319.5 would be amended by removing the second sentence
of paragraph (e)(2) and revising the first sentence to read as follows:
Sec. 319.5 Mechanically Separated (Species).
* * * * *
(e) * * *
(2) A prerequisite for label approval for products consisting of or
containing ``Mechanically Separated (Species)'' is that such
``Mechanically Separated (Species)'' shall have been produced by an
establishment under a establishment quality control system. * * *
18. The last sentence in footnote 3 to the chart in Sec. 319.104
would be amended by removing the words ``approved by the Administrator
under Sec. 318.4 of this subchapter.''
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS
19. The authority citation for Part 381 would be revised to read as
follows:
Authority: 7 U.S.C. 138f, 450; 21 U.S.C. 451-470; 7 CFR 2.18,
2.53.
20. Section 381.19 would be revised to read as follows:
Sec. 381.19 Application for inspection; irradiation facilities.
All applicants for inspection whose operations include irradiation
and other processing would submit, to the Administrator, a proposed
quality control system as specified in Sec. 381.149.
Sec. 381.20 [Amended]
21. Section 381.20 would be amended by removing ``the approved
drawings,
[[Page 19590]]
specifications, and'' from the first sentence.
22. Section 381.53 would be amended by removing paragraph (b);
redesignating paragraphs (c) through (m) as paragraphs (b) through (l),
respectively; and revising paragraph (a) to read as follows:
Sec. 381.53 Equipment and utensils.
(a) Equipment and utensils used for processing or otherwise
handling any edible poultry product or ingredient thereof, in any
official establishment, shall comply with any applicable provisions of
paragraphs (b) through (l) of this section and otherwise shall be of
such material and construction as will facilitate their thorough
cleaning, insure cleanliness in the preparation and handling of all
edible poultry products, and avoid adulteration and misbranding of such
products. In addition to these requirements, equipment and utensils
shall not in any way interfere with or impede inspection procedures.
Receptacles used for handling inedible products shall be of such
material and construction that their use will not result in
adulteration of any edible product or in unsanitary conditions at the
establishment, and they shall bear conspicuous and distinctive marking
to identify them as only for such use and shall not be used for
handling any edible poultry products.
* * * * *
Sec. 381.121d [Amended]
23. Section 381.121d would be amended by removing the words ``or
Partial Quality Control Program'' from paragraph (b).
24. The section heading and paragraph (d) of Sec. 381.145 would be
revised to read as follows:
Sec. 381.145 Preparation of products to be officially supervised;
responsibilities of official establishments; establishment operated
quality control.
* * * * *
(d) Partial Quality Control Programs. (1) Any owner or operator of
an official establishment preparing meat food products who is using a
quality control program for a product, operation, or part of an
operation shall make the written program and data and information
generated by the program available to Program employees.
(2) (i) Such quality control program shall include, as appropriate
for the product, operation, or part of an operation which the program
concerns, detailed information on: raw material control, the critical
check or control points, the nature and frequency of tests to be made,
the charts and records that will be used, the length of time such
charts and records will be maintained in the custody of the official
establishment, the limits which will be used and the points at which
corrective action will be taken to prevent recurrence of a loss of
control, and the nature of the corrective action--ranging from the
least to the most severe.
(ii) Such quality control program shall be designed so as to
provide, with at least 85 percent statistical confidence, that the lot
mean (process mean) is within the product or label limit used and that,
of a minimum of 3 sublot samples representing the lot, with each sublot
sample containing at least 5 samples representing the sublot, no
individual sample mean or sublot-sample mean shall be greater than
three standard errors above, nor less than three standard errors below,
the process mean.
* * * * *
25. Paragraph (e) of Sec. 381.145 would be amended by removing the
words ``Programs or'' from the paragraph heading, the words ``or (d)''
from the first sentence of paragraph (e)(1) and both occurrences of ``,
partial quality control program,'' from the second sentence of the same
paragraph (e)(1); by removing the words ``or program'' from the first
and second sentences of paragraph (e)(2); by removing ``, partial
quality control program,'' from paragraph (e)(3); by revising the
heading of paragraph (g) and removing the words ``or a partial quality
control program'' from paragraph (g)(1); by removing ``, partial
quality control program,'' from paragraph (g)(2) introductory text and
the words ``or program'' from the first sentence of paragraph
(g)(2)(ii); and by revising paragraph (g)(3) to read as follows:
Sec. 381.145 Preparation of products to be officially supervised;
responsibilities of official establishments; establishment operated
quality control.
* * * * *
(g) Termination of Total Establishment Quality Control.
* * * * *
(3) If approval of the total establishment quality control system
has been terminated in accordance with the provisions of this section,
an application and request for approval of the same or a modified total
establishment quality control system will not be evaluated by the
Administrator for at least 6 months from the termination date.
* * * * *
Sec. 381.309 [Amended]
26. Paragraph (a) of Sec. 381.309 would be amended by removing the
words ``an approved'' and ``program'' and paragraphs (b) and (c) of
Sec. 381.309 would be amended by removing ``and submitted to the
Administrator for approval''.
Done, at Washington, DC April 25, 1996.
Michael R. Taylor,
Acting Under Secretary for Food Safety.
[FR Doc. 96-10795 Filed 5-1-96; 8:45 am]
BILLING CODE 3410-DM-P
