# Elimination of Prior Approval Requirements for Establishment Drawings and Specifications, Equipment, and Certain Partial Quality Control Programs

> Briefs, arguments, decisions, and more.

URL: https://www.frixlaw.com/law-library/documents/fr%3A97-21882

## Record

- **Collection:** Federal Register
- **Document type:** Rule
- **Published:** August 25, 1997
- **Citation:** 62 FR 45016

## Text

DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Parts 304, 308, 317, 318, 319 and 381

[Docket No. 95-032F]
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: Final rule.

-----------------------------------------------------------------------

SUMMARY: The Food Safety and Inspection Service (FSIS) is amending the
Federal meat and poultry products inspection regulations by removing
the requirements for prior approval by FSIS of establishment drawings,
specifications, and equipment used in official establishments.
Requirements involving the comparison of blueprints and specifications
with actual facilities and equipment will end, affording industry the
flexibility to design facilities and equipment in the manner they deem
best to maintain a sanitary environment for food production. FSIS will
continue to verify through inspection that sanitation requirements are
being met. FSIS is also ending 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 will enable establishments to
develop and implement quality control programs without first having to
receive permission from FSIS to do so. This action is being taken as
part of FSIS's regulatory reform effort to improve FSIS's meat and
poultry food safety regulations, better define the roles of Government
and the regulated industry, encourage innovations that will improve
food safety, and remove unnecessary regulatory burdens on inspected
establishments.

DATES: Effective Date: September 24, 1997.
Comments: Comments on the guidance material published as Appendices
A and B of this document must be received by October 24, 1997.

ADDRESSES: Submit one original and two copies of written comments to:
FSIS Docket Clerk, DOCKET #95-032F, U.S. Department of Agriculture,
Food Safety and Inspection Service, Room 102, 300 Twelfth Street, S.W.,
Washington, DC 20250-3700.

FOR FURTHER INFORMATION CONTACT: Ms. Patricia F. Stolfa, Assistant
Deputy Administrator, Office of Policy, Program Development, and
Evaluation, FSIS, Room 402 Annex Building, Washington, DC 20250-3700;
(202) 205-0699.

SUPPLEMENTARY INFORMATION:

Background

The Federal meat and poultry products inspection regulations
currently require establishments applying for inspection to submit to
FSIS multiple sets of drawings and specifications of the facilities for
approval before inspection can be granted (9 CFR 304.2, 381.19). The
regulations require plans to be submitted to the Agency for approval
before any remodeling of facilities (9 CFR 308.2, 381.19(e)). The
regulations also require approval by FSIS of equipment and utensils
proposed for use in preparing edible product or product ingredients in
official establishments (9 CFR 308.5, 381.53). Further, the regulations
require Agency approval of partial quality control programs before
establishments can use them for control of food processing or for other
uses (318.4 (d)-(g), 381.145 (d)-(g)).
FSIS proposed in the May 2, 1996, Federal Register (61 FR 19578) to
amend these regulations to eliminate requirements for FSIS prior
approval. The Agency also proposed a minimum standard for the design of
PQC programs that is comparable to the standard for programs the Agency
has approved. For the reasons given in the preamble to the proposal and
in this final rule, FSIS is adopting the proposed amendments with some
additional changes occasioned by FSIS's review of the proposed rule and
the comments on that proposal.

Comments

FSIS received 27 comments during the public comment period that
ended September 9, 1996. Five were from industry consultants, seven
from equipment manufacturers and engineering firms, eight from food
companies, four from trade associations, one from a law firm
representing packers and equipment manufacturers, and two from State
departments of agriculture. Twelve commenters expressed qualified
support for eliminating prior approval of equipment and facility
blueprints, thirteen favored keeping the present approval system, and
two suggested alternatives. All 13 comments received on the specific
issue of eliminating PQC prior approvals supported the proposed change.
In addition to the comments submitted on the May 2, 1996, proposal,
five comments supporting the elimination of prior approvals were
submitted in response to the Agency's December 29, 1995, advance notice
of proposed rulemaking ``FSIS Agenda for Change: Regulatory Review.''
Four of the five comments were from persons who also commented on the
May 2 proposal.
The following summarizes the comments on the proposal and Agency
responses by major topic addressed.

Circuit Supervisor and Inspection Decisions

Most commenters, whether favoring or opposing the proposal,
expressed concern that eliminating prior approvals of facilities and
equipment would leave establishments without documented approvals with
which to counter adverse judgments by circuit supervisors during
walkthroughs conducted before the granting of inspection or by field
inspectors during daily establishment operations. The commenters feared
that conflicts arising over decisions by such Agency personnel could
delay production and otherwise burden establishments. Ten commenters
opposed the proposal for this reason. Six others, though favoring the
proposal, had the same concern and thought the Agency should take steps
to prevent or minimize any disruptions arising from decisions made by
local Agency personnel.
These commenters tended to assume that FSIS inspection will not
change in conjunction with the regulatory reforms now taking place.
FSIS disagrees. FSIS inspection roles will change significantly under
the recently promulgated final rule ``Pathogen Reduction; Hazard
Analysis and Critical Control Point (HACCP) Systems'' (61 FR 38806;
July 23, 1996). Under this rule, FSIS personnel will verify the
effectiveness of processes and process controls designed to ensure food
safety. FSIS is preparing the inspection workforce to oversee the
safety of meat and poultry products under this new HACCP-oriented
inspection. FSIS personnel will focus on an establishment's ongoing
compliance with HACCP-consistent requirements. Inspectors will carry
out verification activities such as reviewing establishment monitoring
records for a process, reviewing records for a production lot, directly
observing critical control point controls conducted by establishment
employees, collecting samples for FSIS laboratory analysis,

[[Page 45017]]

and verifying establishment verification activities for a process.
Inspection findings that affect facilities or equipment will be
made in the context of such verification activities. Inspectors will
retain the authority to reject facilities or equipment wherever
appropriate and warranted by the circumstances. Establishments will
have the responsibility to take corrective action when they discover
process deviations while operating their HACCP systems. Proper design
and implementation of sanitation standard operating procedures (SOP's)
and the HACCP system will minimize any differences of opinion with
Agency personnel that may occur.

Provision of Guidance Material, Transition to HACCP

A number of commenters (8) who favored the proposal thought that
the Agency should make guidance materials on facilities and equipment
available to inspectors and establishments, especially to small
establishments. These commenters stated that the guidance materials,
including a revised Agriculture Handbook 570, U.S. Inspected Meat and
Poultry Packing Plants: A Guide to Construction and Layout, and
equipment acceptability standards, would help maintain uniformity and
consistency in inspection decisions and would also be of use to small
establishments. One commenter thought there should be periodic updates
to Handbook 570. Some commenters stressed that the Agency should
emphasize to inspectors that the guidance documents are not rules and
regulations, but are intended to illustrate basic principles to be
applied in a variety of situations.
As explained in the proposal, FSIS is preserving the final edition
of Agriculture Handbook 570 and the general guidance material in MPI-2,
Accepted Meat and Poultry Equipment, for reference. This guidance
material is appended to this document as Appendix A. The Agency agrees
with the commenters that this guidance material should not be
interpreted as a set of regulations, but as a statement of basic
principles with illustrative examples. The specific application of
these principles will depend, in part, on the establishment's
implementation of its sanitation standard operating procedures and its
HACCP plan. The Agency also plans to issue a final list of approved
equipment, reflecting FSIS decisions through November 1996. Appendix A
is a final draft on which the Agency will accept comments for 60 days.
Comments on whether the material is clear and useful will be especially
helpful in finalizing the material.

Effect on Small Companies

A few commenters (3) thought that eliminating prior approvals would
be harmful to small companies that are unable to hire experts in food
processing facilities or equipment to assist them in complying with
regulatory requirements.
As explained above, FSIS has prepared technical guidance material
on facilities and equipment that should be especially useful to small
establishments. The Agency will continue to maintain a small staff of
experts at Washington headquarters to monitor developments in food
technology and disseminate advice and materials concerning applications
of the technology. The Agency also plans to make the technical guidance
material it develops available to the public in electronic format.

Prestige of USDA Acceptance

One commenter thought that, with the ending of the FSIS acceptance
program for equipment, U.S. manufacturers would suffer a disadvantage
in international markets for food processing equipment. The commenter
stated that equipment manufacturers were previously able to trade on
the value of USDA acceptance of their products for use in federally
inspected plants.
Although FSIS appreciates the fact that its decisions on meat and
poultry slaughtering and processing equipment are valued, the
acceptance program was never intended for equipment market promotion.
Its purpose was to help ensure that meat and poultry establishments
would operate in a safe, sanitary manner, producing and shipping only
wholesome, unadulterated meat and poultry products.

Limited Value of Prior Approval

One commenter agreed and another disagreed with the Agency's
contention that an initial determination that meat and poultry
facilities and equipment meet Agency requirements is of limited value.
Prior approval does not guarantee that establishments will continuously
operate facilities and equipment in a safe and sanitary manner. FSIS's
position, as previously stated, is that effective sanitation SOP's and
HACCP systems will meet the same objectives as prior approvals.

Third-Party Certifications

Several commenters suggested the use of third-party certifications
of facilities and equipment. One commenter favoring the proposal
suggested that FSIS consider the voluntary use by establishments of
third-party assessment and registration programs to ensure the
development and implementation of effective sanitation and HACCP
programs.
FSIS agrees with the commenter that third-party programs can make a
useful contribution to the effort of developing and implementing
sanitation SOP's and HACCP plans. The Agency, realizing that some
establishments will be unable to avail themselves of these services and
that many will not need to, is not requiring the use of such services.
Also, the Agency does not intend to formally recognize or accredit such
services. However, FSIS agrees that third-party certification services
may be advantageous to many establishments and would support an
industry initiative in this area. An example of such a third-party
certification service is the 3-A Sanitary Standards Committee, which
conducts a certification program for equipment used in dairy and egg
products processing establishments.

Number of Blueprint Submissions and Evaluation

One commenter disputed the number of blueprint submissions to the
Agency during fiscal year 1994 (2,100, versus the Agency's estimate of
2,900) and the Agency's attribution of most rejections to paperwork
errors. The commenter asserted that most rejections were attributable
to deficiencies that could affect food safety. The commenter also
suggested that because the proposal was based, in part, on the Agency's
incorrect estimate of the number of blueprints it evaluated and the
reasons for returns and rejections of the blueprints, the basis for the
proposal was faulty, and that, for this reason, the proposal ought to
be withdrawn.
FSIS's estimate of the number of submissions at about 2,900 for
fiscal year 1994 was derived from information in a blueprint evaluation
database that was intended to show trends in workflow through the
Washington review staff rather than absolute numbers of submissions. In
fiscal year 1994, the Agency also maintained a separate count of
returns of blueprints to their originators. Some blueprint sets go back
and forth between the Agency and the originating establishment several
times before they are approved. The Agency used a sample of blueprint
evaluation records from the database,

[[Page 45018]]

adjusted for multiple returns, in estimating the number of submissions
it handled.
The commenter's count may have been based, in part, on internal
Agency reports. The data in those reports is comparable to the data
used by the Agency in arriving at its estimate. FSIS considers the
commenter's count as a reasonable lower-bound estimate of the number of
submissions and is using it for the purpose of assessing the impact of
this rule.
However, FSIS disagrees with the commenter's belief that most
blueprint rejections were the result of factors affecting food safety.
During periods of high workload, the Agency's Washington staff has
tended to return a higher proportion of blueprint sets with
administrative errors to the originating establishments and request
resubmission. During periods of lower workload, the staff has been able
to telephone establishments, offer advice relating to the compatibility
of blueprints with guidelines, and receive corrections of
administrative errors by fax. The percentage of returns to correct
specifications that have implications for food safety was somewhat
higher in periods of lower workload than in high-workload periods. Most
recently, it has been the policy of the blueprint review staff to focus
strictly on regulatory compliance--that is, on checking for
specifications required by the regulations--rather than on
compatibility with guidelines. As a result, the percentage of blueprint
returns attributable to paperwork errors has been higher than in the
past.
The estimate of blueprint submissions and rejections was used to
conduct a regulatory impact assessment. Moreover, the Agency's estimate
of impact is only a part of the basis for the rule. As stated in the
preamble to the proposal, there are several other important reasons for
the rule. First, it is important to note that the Federal Meat
Inspection Act and the Poultry Products Inspection Act do not require
prior approval of facilities, equipment, and quality control programs.
More importantly, prior approvals are limited in scope because they
apply only to certain aspects of establishment operations and in time
because they are given only once. The establishment is and has always
been responsible for maintaining sanitary facilities and equipment
every day it operates. Also, prior approval is a feature of the
traditional command-and-control approach to regulation that can be an
obstacle and deterrent to innovation. Eliminating prior approvals is
consistent with the new regulatory requirements for establishment-
operated sanitation SOP's and HACCP systems, under which the
establishments will fulfill their responsibility for determining and
implementing process controls that will assure food safety. Under these
new requirements, prior approval is an inappropriate allocation of
responsibility between the Agency and establishments.

Enforcement, Dispute Resolution, and Appeals

A number of commenters (4) asked what recourse establishments would
have if FSIS took action against or refused to allow the use of
equipment or facilities that had not previously been approved by FSIS.
Commenters asked whether appeal procedures would be provided or whether
another form of dispute resolution would be available to establishments
if the proposal were adopted.
FSIS understands the concern and is developing procedures for
resolving issues such as these which may arise under the HACCP-based
inspection system. The Agency emphasizes, however, that under the new
program, inspectors will not be evaluating equipment and facilities
directly. Rather, inspectors will evaluate the operational
effectiveness of facilities and equipment in preventing direct product
contamination and other hazards.
FSIS is currently revising its rules of practice and will include
procedures for dispute resolution and appeals of FSIS decisions. Until
those rules of practice become effective, current enforcement and
appeal procedures will continue to be followed.

Partial Quality Control Programs

As mentioned above, 13 comments favored the elimination of prior
approval of establishment-operated PQC programs, but most were
accompanied by questions and suggestions concerning the Agency's policy
on PQC approvals.

Continued Prior Approval of Certain Quality Control Programs

Three commenters asked why the Agency was eliminating prior
approval for certain PQC programs, but retaining prior approval
requirements for other PQC programs. One commenter noted that the
proposal did not address prior approval of Total Quality Control
programs.
Although eliminating most prior approvals, FSIS is retaining
certain specific regulatory provisions for prior approval of PQC
programs. These include programs associated with certain slaughter
inspection systems and with food irradiation facilities. Also, this
final rule does not eliminate prior approval of TQC programs. The
Agency plans to deal with these issues during the next few months in
rulemakings intended to address the remaining prior approval
requirements for PQC and TQC.

Specific Requirements for PQC Programs

A number of commenters questioned the requirements that PQC
programs would have to continue to meet. Two commenters wondered why
the Agency was prescribing design criteria for PQC programs, including
the required elements and minimal statistical confidence, when they
were eliminating prior approval. Another commenter thought that the
National Institute of Standards and Technology (NIST) Handbook 133,
concerning net weight, should be amended to eliminate specific
references to approved PQC programs.
The PQC program design criteria set forth in the regulations are
consistent with those currently observed by the industry. The Agency
proposed the requirements, including the 85-percent statistical
confidence criterion, to provide the industry with a set of minimum
standards for PQC programs. A sampling plan should be consistent with
the principles of statistical process control and the proposed
requirement included such a plan. Nevertheless, the Agency agrees that
a precise sampling plan does not have to be set out in the regulations.
The Agency also agrees that the proposed specifications relating to the
minimum confidence level, individual sample means, and sublot means are
too prescriptive. Accordingly, these specifications are not being
adopted in this final rule.
Further, establishments are not required to include all the
features presented in proposed Secs. 318.4(2)(ii) and 381.145(2)(ii) in
its individual PQC programs. The final rule only requires that a PQC
program include those elements that are ``appropriate for the product,
operation, or part of an operation which the program concerns.'' The
final rule also requires that generally recognized statistical process
control procedures be used to determine process control. However, the
final rule is worded to accommodate control procedures that are not
statistically based or that do not have measurable control limits, such
as the in-plant control procedures for grade-labeled product.
As to NIST Handbook 133, FSIS does not see a need to amend the
Handbook at this time. The Handbook states that

[[Page 45019]]

data generated by USDA-approved PQC programs can be used to
substantiate lot compliance with net weight requirements. Even without
prior approval by FSIS, a PQC program meeting the requirements of this
final rule could generate data appropriate for determining product
compliance with net weight requirements. Such data will be recognized
and checked by FSIS inspection personnel just as data generated by
prior-approved PQC programs have been until now.
In order to facilitate establishment development of PQC programs
that meet the requirements of this final rule, the Agency has developed
guidance material which includes the criteria it used to determine
whether or not PQC's were acceptable. The guidance material, which is
included as Appendix B, may be used by establishments at their
discretion.
Appendix B, as with Appendix A, is a final draft on which the
Agency will accept comments for 60 days. Comments on whether the
material is clear and useful to establishments will be especially
helpful in making final revisions to the Appendix.
Upon publication of this final rule, FSIS will revise Agency
directives and other documents referring to PQC's. The category of
``conditional'' PQC's in these documents will be eliminated and the
categories ``mandatory'' and ``voluntary'' will remain. The
``mandatory'' category will be abolished once all regulations requiring
Agency-approved PQC's for certain processes have been amended.

Effect of Mandatory HACCP on PQC Programs With Public Health
Implications

Two industry commenters wanted to know what effect the HACCP
requirements would have on existing and future PQC programs, which
include measures relating to public health or safety protection.
Although this final rule eliminates the requirement for prior approval
of most PQC programs, PQC programs remain an option for controlling
certain processes. As HACCP is implemented in an establishment, safety-
related PQC programs will most likely be incorporated into the
establishment's HACCP plan. As HACCP plans are implemented throughout
the meat and poultry industry, public health-related PQC programs will
no longer be needed. Establishments will, of course, continue to be
able to develop and use PQC programs that control ``economic'' factors.
A State government suggested that the Agency continue prior
approval of such PQC programs. FSIS disagrees. The Agency's position is
that such control programs should be implemented voluntarily, at the
establishment's discretion.

Third-Party Certification of PQC Programs

One commenter suggested that FSIS make use of third-party
certification services for PQC programs.
As stated above, third-party certification services may be useful
and advantageous to many establishments, and FSIS would support
industry initiatives in this regard. However, the Agency does not plan
to require third-party certification or to officially recognize,
accredit, or oversee their operations.

Export Requirements

One commenter noted that some foreign countries require product
exported to them from U.S. establishments to have been processed under
approved PQC programs, and requested that the foreign requirements be
changed to accord with the new U.S. regulations.
However, FSIS has no direct control over the requirements of
foreign governments. Establishments must abide by the requirements of
the countries to which they export. Since FSIS is no longer approving
PQC programs, if a foreign government requires a U.S. establishment to
process product exported to that government's territory under an
approved PQC program, then the establishment should obtain approval for
the program from that government.

The Final Rule

FSIS is adopting the provisions in the proposal in essentially the
same form as proposed, but with some technical changes. In
Secs. 318.4(d) and 381.145(d), concerning PQC programs, the phrase ``is
required to have'' replaces ``is using'' for greater consistency with
the intent to provide flexibility to establishments and reduce
regulatory paperwork burdens associated with voluntary PQC's. As
mentioned, some of the PQC program design criteria in proposed
Secs. 318.4(d)(2)(ii) and 381.145(d)(2)(ii) are not being adopted.
Also, Secs. 318.4(d)(2)(ii) and 381.145(d)(2)(ii) are worded to
accommodate procedures that do not have measurable limits, as well as
statistically based PQC's.
Additionally, FSIS is making certain technical corrections in this
final rule, which are occasioned by FSIS's review of the proposed rule
and the comments on that proposal. The wording of amended Secs. 317.21,
318.19(e) and 381.121d is changed somewhat from the proposed wording to
clarify that certain requirements for quality control will continue
even though the prior approval requirements for PQC programs are
removed. The proposal did not include proposed amendments eliminating
the prior-approval requirement for blueprints of import inspection
establishments or of establishments operating under State meat or
poultry inspection programs that are ``at least equal to'' the Federal
program. The revised 9 CFR 327.6(d), 331.3 and 381.222 eliminate these
prior-approval requirements. States may continue to require
establishments to submit blueprints for approval as a condition of
receiving inspection, but because FSIS is eliminating its prior
approval programs, the Agency will no longer consider prior approval of
blueprints to be a necessary feature of an ``at least equal''
inspection program.
Also, FSIS inadvertently omitted changes, consistent with the
intent of this rulemaking, to some sections of the regulations that
refer to PQC prior approvals. These sections include 9 CFR 319.105, on
the processing of cured ham products and 9 CFR 318.308 and 381.308, on
the processing of canned foods. The final rule amends these sections of
the regulations to eliminate the references to PQC prior approvals.

Relationship to Sanitation SOP's and HACCP

Beginning on the effective date of this final rule, establishments
will no longer be required to submit drawings and specifications of
facilities to FSIS for approval before beginning inspected activities
or before remodeling facilities. They will no longer be required to use
only FSIS-approved utensils and models of equipment.
Establishment operators must be aware of two things, however.
First, in carrying out sanitation SOP's required by the Pathogen
Reduction/HACCP regulations, if corrective action is necessary to
maintain or restore sanitary conditions, an establishment may have to
repair or replace facilities or equipment. FSIS inspectors will be
verifying the establishment's operation of its sanitation SOP's. If,
during verification activities, inspectors find that the SOP's are not
being effectively implemented, they will have the full range of
compliance measures available, including the rejection of equipment and
areas of the establishment. It will be the responsibility of the
establishment to take action with respect to any equipment or
facilities that may be causing a sanitary hazard.

[[Page 45020]]

Second, in conducting the hazard analyses required to develop its
HACCP plan, an establishment must determine all factors that may
contribute to the emergence of hazards and the measures necessary to
prevent or minimize those hazards. This means that the establishment's
facilities and equipment must be designed to permit the process
governed by the HACCP plan to be carried out. The facilities and
equipment must be capable of meeting the applicable processing
requirements of a product, must be cleanable, and must not become a
source of hazards to the product. For example, facilities and equipment
should be maintained so that product is not exposed to physical hazards
such as paint chips, rust particles, or loose machine parts.
Establishments will be responsible for consulting with equipment
manufacturers as necessary to complete their hazard analyses and
identify appropriate critical control points (CCP's) while developing
their HACCP plans. Establishments will be expected to take appropriate
corrective actions whenever they find deviations from process critical
limits while operating their HACCP systems. The actions necessary to
correct a problem may, at times, require maintenance, repair, or
replacement of equipment or facilities.
FSIS personnel will verify that establishments are effectively
operating their HACCP systems. If FSIS finds a pattern of recurring
hazards to product caused by facilities and equipment, the Agency has,
and will exercise where appropriate, the authority to take action on
product, equipment, or facilities. In those situations where FSIS finds
a pattern of recurring hazards to product, it will be indicated that
the HACCP plan is inadequate and the plan may have to be redesigned and
revalidated. Improving the establishment's facilities and equipment
could well be among the steps necessary to redesign and revalidate the
HACCP plan.
FSIS findings will not be directed primarily at the acceptability
of facilities and equipment per se, but at the functioning of the HACCP
plan in operation. In other words, if hazards to product are not being
prevented or critical control points are failing, the failure may be
the result of inadequate facilities or equipment and the establishment
will be required to correct the problem.

Equipment and Utensils

FSIS will no longer evaluate equipment or utensils for acceptance.
As mentioned earlier in this document, the final edition of MPI-2,
Accepted Meat and Poultry Equipment, is being published for reference
purposes. Adequate sanitary design of equipment will be ensured through
establishment implementation of SSOP's and HACCP plans.
Equipment and utensils must continue to meet the general standard
that they are of a material and construction that will facilitate
thorough cleaning and cleanliness in preparing edible product and must
not interfere with or impede inspection procedures. (9 CFR 308.5(a),
308.15, 381.53(a)(1).) FSIS has authority to prevent the use of
equipment or facilities that pose a threat to public health or
interfere with inspection. FSIS must be notified in advance of any
changes to facilities or equipment that may interfere with or force
changes to FSIS's inspection operations.

PQC Programs

With respect to PQC programs, under this final rule inspectors will
verify that establishments have written PQC programs on file, with data
and information available to the inspectors, and that the process
limits prescribed by the programs are being met. The establishments
will be responsible for developing PQC programs that meet the
regulatory requirements but there is no requirement for the programs to
be approved in advance of their use. The establishments may seek advice
from the Agency concerning requirements for such programs. As mentioned
previously, draft guidance material on PQC programs is provided in
Appendix B to this document.

Disposition of FSIS Files on Establishment Facilities

In concluding its prior approval activity for establishment
drawings and specifications, FSIS will archive or otherwise dispose of
the files of its facilities review staff. Establishment drawings and
specifications and files, many of which contain proprietary
information, will be destroyed with appropriate security under official
supervision.

Executive Order 12988

This final rule has been reviewed under Executive Order 12988,
Civil Justice Reform. This rule: (1) preempts all State and local laws
and regulations that are in conflict with this rule; (2) has no
retroactive effect; and (3) does not require administrative proceedings
before parties may file suit in court challenging this rule.

Executive Order 12866 and Effect on Small Entities

FSIS is eliminating prior approval requirements for establishment
drawings and specifications, equipment, and certain partial quality
control programs. Concurrently with this final rule, FSIS is
restructuring inspection activities to focus more attention on the
ability of establishments to maintain a sanitary environment. These
actions, in addition to implementation of the sanitation standard
operating procedures required by the Pathogen Reduction/HACCP rule,
will provide the industry the flexibility for creating and maintaining
a sanitary working environment without prescriptive command-and-control
requirements.
Removing these requirements affects 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 final rule will
reduce demands on FSIS resources which can be redirected to functions
more critical to assuring food safety.
FSIS considered a number of alternatives, including that of making
no rule changes, before adopting this final rule. The Agency rejected
the alternative of no rule changes because not changing the regulations
would leave in place a prescriptive regulatory regime for equipment,
facilities, and processes that conflicts in a material way with the
objectives of the Pathogen Reduction/HACCP final rule. Under HACCP,
establishments will assume responsibility for sanitation and for
building science-based, preventive process controls into the food
production system to reduce or eliminate food safety hazards. This will
include taking responsibility for ensuring that facilities, equipment,
and processes conform with sound sanitation principles and food safety
performance standards. The existing requirements can also impede the
ability of establishment management to implement, on a timely basis,
better and more innovative food safety strategies.
Alternatives to facilities and equipment prior approvals that FSIS
considered 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 prior approval

[[Page 45021]]

services on a voluntary, user-fee basis, was also considered.
FSIS rejected the alternative of publishing booklets containing
detailed facility and equipment standards because, although
establishments would assume responsibility for determining whether
their facilities and equipment comply with the standards,
establishments would remain without flexibility to implement innovative
technologies that appear to depart from the written standards. It is
also likely that, under this alternative, the Agency would continue to
exercise discretionary prior approval authority over the introduction
of new food safety technologies. Moreover, the Agency's inspection of
facilities and equipment for compliance with the published standards
would divert resources needed to verify SSOP's and HACCP systems. As
mentioned above, however, FSIS is publishing draft guidance material on
facilities and equipment as Appendix A of this document.
FSIS also rejected the alternative of officially recognizing
industry organizations as prior-approval authorities for facilities and
equipment. As mentioned earlier in this document, although such
services may be beneficial to some establishments, many will not need
and some will be unable to use such services. Thus, FSIS does not
intend to provide official accreditation or certification of such
services. The Agency's verification of SSOP and HACCP systems is
intended to be its primary means for determining the adequacy of
establishment food safety protective measures, including those measures
that depend on well designed and maintained facilities and equipment.
FSIS also rejected the alternative of continuing its prior approval
of facilities and equipment on a user-fee basis. This alternative had
essentially the same drawbacks as the alternative of no rule changes.
It would not have appropriately separated the roles of the
establishment and the Agency. It would have perpetuated adherence to
prescriptive design standards rather than setting food-safety
performance standards for establishments to achieve. Finally, this
alternative would have continued to pose the same regulatory obstacles
to innovation as the current system.
FSIS chose the option of eliminating prior approval requirements
for facilities and equipment, while maintaining the general food safety
standards in the existing regulations. This action will remove
regulatory obstacles to innovation and command-and-control requirements
inconsistent with the objectives of the Pathogen Reduction/HACCP final
rule and the Agency's food safety regulatory strategy and will yield
immediate and near-term benefits. As stated in its December 29, 1995,
advance notice of proposed rulemaking, the Agency is considering
replacement of more of its detailed regulatory requirements with
performance standards. Such changes will be addressed in future
documents.
The alternatives to PQC prior approvals were market sampling of
finished products, mandating additional in-plant controls, sampling
finished products for chemical analysis, and general requirements and
standards for PQC programs.
FSIS regards market sampling as a potentially useful tool for
enforcing the statutes prohibiting commerce in adulterated and
misbranded meat and poultry products and for checking the effectiveness
of establishment process controls. Sampling and testing products in the
marketplace can also help in addressing food safety hazards arising in
post-processing distribution of meat and poultry products. However, the
Agency did not see a need for specific regulatory requirements
concerning such sampling.
The alternative of mandating additional in-plant controls in lieu
of PQC prior approvals would result in prescriptive, command-and-
control requirements and restrict the scope for establishment food
safety innovations, thereby defeating the purpose of this rulemaking.
In-plant sampling of finished products for chemical analysis also
is a potential tool that FSIS has used to verify the effectiveness of
in-plant controls. The Agency saw no need, however, for a specific
regulatory mandate to conduct such sampling and analysis.
FSIS chose the option of providing general requirements for PQC
programs that establishments would have to meet. This option seemed to
provide establishments with the most flexibility in implementing PQC
programs and a standard applicable to a range of processes.

Benefits of the Rule

Approximately 6,200 federally inspected meat and poultry
establishments will no longer be required to submit blueprints,
drawings, and specifications to FSIS for prior review and approval.
FSIS reviewed an estimated 2,100 to 2,900 submissions in FY 1994. The
range of the estimate is attributable to the fact that an indeterminate
number of blueprints were returned to establishments and resubmitted to
the Agency, some several times, before being accepted. 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 $21,000 to $40,000. This
figure is an estimate of the savings accruing to industry by removing
the requirement for prior approval.
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. 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 cost of these applications generally falls 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 estimates that
the costs to manufacturers of applying for equipment approval are
comparable to the costs to establishments of submitting blueprint and
establishment specification approvals. 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 will be in the range of $25,000 to $32,500.
In addition, approximately 650 applications for approval are contingent
on in-plant trials, which involve some added costs to manufacturers and
meat and poultry establishments. The Agency has no estimate of these
costs to include in this analysis.
The elimination of blueprint prior approvals will remove a source
of income for approximately 20 small firms, known as ``expediters,''
that represent official establishments for the purpose of labeling and
blueprint approval. On the basis of information submitted during the
comment period, the Agency understands that approximately 35 percent
(or about 735 to 1,015) of the annual blueprint submissions to the
Agency are made

[[Page 45022]]

using expediters. The estimated annual total value of blueprint
expediting is about $300,000 to $400,000 for the companies involved.
Since the income lost to the expediters will be transferred to meat and
poultry firms, it is not a cost of the final rule.
The benefits directly resulting from the elimination of prior
approval requirements in accordance with this rulemaking are indicated
in Table 1. There also will be additional, unquantifiable benefits
resulting from fewer demands on establishment 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, will be
eliminated.
Moreover, it is unlikely that any inspection finding of adulterated
product or insanitary conditions under the amended regulations will
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 eliminating these prior
approval requirements, FSIS expects 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 will flow from reallocating these
resources to more important food safety-related tasks.

Costs of the Rule

As is currently the practice, establishments will continue to be
required 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. A finding of product adulteration or insanitary conditions
will entail corrective action which, in some cases, may involve
reconstruction, remodeling, or redesign of facilities and equipment.
However, it is unlikely that this rule will increase the level of
inspection findings that result in such reconstruction, remodeling, or
redesign primarily because, as mentioned, most establishments consult
with knowledgeable authorities before major construction or
installations. Also, proper operation of sanitation SOP's and HACCP
systems will reduce the occurrence of adverse inspection findings.
Under existing regulatory requirements, facility and equipment
plans submitted to FSIS for prior approval were rejected due either to
errors in paperwork or to deviation from specific design criteria
developed by FSIS. Under the final rule, establishments will be
permitted to initiate and complete construction or introduce new
equipment without submitting any paperwork to FSIS. In addition, FSIS
will eliminate design-related criteria currently utilized to evaluate
the acceptability of facilities and equipment. Establishments will not
have to incur costs for reconstruction, remodeling, and redesign
because the facility or piece of equipment does not match a specified
design criterion, blueprint, or equipment specification.
In the absence of prior approval, FSIS will focus inspection on
whether establishments are maintaining a sanitary environment. Under
this final rule and the Pathogen Reduction/HACCP regulations,
establishments will assume greater control over their production
practices to ensure that a sanitary environment is maintained.
Currently, many establishments utilize the services of architects,
engineers, and other experts to design facilities and equipment for use
in meat and poultry establishments. Under the regulations requiring
prior approval, these experts ensured, among other things, that FSIS
design specifications were 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 will be commensurate with the transfer of responsibility from
FSIS to the industry, and will not be a social cost attributable to the
rule.

Table 1.--Benefits to Firms From Eliminating Prior Approval Requirements
----------------------------------------------------------------------------------------------------------------
Information
Firms with more Firms with fewer collection burden
Action than 500 than 500 All firms reduction--all
employees employees firms (in hours)
----------------------------------------------------------------------------------------------------------------
Remove blueprint and specification
approval........................... $1,260-2,400 $19,740-37,600 $21,000-40,000 701
Remove equipment approval........... 2,500-3,250 22,500-29,250 25,000-32,500 2,990
Remove PQC approval................. 9,000-11,400 141,000-178,600 150,000-190,000 540
---------------------------------------------------------------------------
Total......................... 12,760-17,050 183,240-245,450 196,000-262,500 4,321
----------------------------------------------------------------------------------------------------------------

Regulatory Flexibility Assessment

The Administrator has determined that, for the purposes of the
Regulatory Flexibility Act (5 U.S.C. 601-12), this final rule will not
have a significant economic impact on a substantial number of small
entities. The entities affected by this final rule 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 final 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 (13 CFR 121.201) that apply to meat packing
establishments, establishments that produce sausages and other prepared
meats, and poultry slaughtering and processing

[[Page 45023]]

establishments. A small establishment in any of these categories is
considered to be one with 500 or fewer employees. Under current
regulations, all establishments are required, as a condition of
receiving inspection, to submit blueprints, drawings, and
specifications of new or remodeled facilities to FSIS for review and
approval. Under this final rule, establishments will continue to incur
the cost of preparing blueprints and specifications for construction
and major installations. However, they will no longer bear the cost of
submitting these drawings and specifications to the Agency for review
because the requirement to do so is being 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 will be in the neighborhood of $21,000-40,000. FSIS
does not consider this savings to be significant. In addition to these
direct savings, the largest potential savings to the industry from this
final rule will be those savings associated with eliminating 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
will be significant for a substantial number of them.
The savings will 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.
Eliminating the cost of blueprint prior approvals to small
establishments producing meat and poultry products will necessarily
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 $300,000 to $400,000 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 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. These 20
entities, in any event, do not constitute a substantial number of small
entities.
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 small
business size standards (13 CFR 121.201), a small food products
machinery manufacturer is one that employs 500 or fewer people. A
substantial number of these small entities, several hundred, will be
affected by this rule. As shown in Table 1, equipment manufacturers and
vendors that are classified as small entities will save in the
aggregate between $22,500 and $29,250 from elimination of the cost of
applying to FSIS for acceptance of equipment. As indicated previously,
equipment manufacturers and vendors will save about $10 to $12.50 per
year on each new equipment model or utensil from not applying to FSIS
for acceptance. FSIS does not consider this effect of the rule to be
significant, even if some firms have submitted several applications per
year.
Also favorably affected by the approval process are inspected
establishments that may want to install newly developed equipment or
apply new technologies to improve their operations. 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, will not be significant for most
establishments.
Finally, FSIS has determined that the elimination of prior approval
of most PQC programs will not have a significant economic impact on a
substantial number of small entities. Although prior approval will be
eliminated, both large and small establishments subject to FSIS
inspection will be permitted to continue to develop and implement PQC
programs for their products and processes. Accordingly, the
administrative delay for review that occurs under the present system
will 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
will 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 final
rule will not have a significant economic impact on a substantial
number of small entities. The economic impact on such entities will, in
most cases, involve the elimination of certain costs--some
quantifiable, some not quantifiable-- associated with doing business
subject to Federal regulation, and hence will 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 final rule.

Paperwork Requirements

FSIS has reviewed the paperwork and recordkeeping requirements in
this final rule in accordance with the Paperwork Reduction Act. This
final rule will substantially reduce ``reporting'' requirements for
official establishments and other entities. FSIS estimates the total
reduction in reporting to be 4,231 burden hours. The reductions will
occur in the following information collection reports:
0583-0082, ``Meat and Poultry Inspection; Application for
Inspection, Sanitation, and Equipment Requirements and Exemptions'':

[[Page 45024]]

Establishments subject to inspection will 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 will 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 will no longer be required for the products of
equipment companies that are used in official establishments. The
response time is 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 will request OMB to remove the 2,990 approved
burden hours.
0583-0089, ``Processing Procedures and Quality Control
Systems'': Establishments can continue to develop and implement PQC
programs according to Agency guidelines. These establishments, with the
exception of poultry irradiation facilities, are no longer 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 will remain. FSIS does not
foresee more than two irradiation facilities requesting FSIS approval
of PQC programs. Therefore, FSIS will request OMB to remove 540
approved burden hours. The burden hours for PQC program development and
reporting remain the same.

List of Subjects

9 CFR Part 304

Drawings, Information to be furnished, Grant or refusal of
inspection, Meat inspection.

9 CFR Part 308

Meat inspection, Sanitation.

9 CFR Part 317

Meat inspection, Reporting and recordkeeping requirements.

9 CFR Part 318

Meat inspection, Establishment-operated quality control.

9 CFR Part 319

Food grades and standards, food labeling

9 CFR Part 327

Imports, meat inspection

9 CFR Part 381

Poultry and poultry products

For the reasons set forth in the preamble, FSIS is amending 9 CFR
Parts 304, 308, 317, 319, 327, and 381 of 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 continues to read as
follows:

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

2. Section 304.2 is amended by revising the heading; removing
paragraph (b); redesignating paragraphs (c) through (f) as paragraphs
(b) through (e), respectively; and revising paragraph (a), to read as
follows:

Sec. 304.2 Information to be furnished; grant or refusal of
inspection.

(a) FSIS shall give notice in writing to each applicant granted
inspection and shall specify in the notice the establishment, including
the limits of the establishment's premises, to which the grant
pertains.
* * * * *

PART 308--SANITATION

3. The authority citation for part 308 continues to read as
follows:

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

Sec. 308.2 [Removed and reserved]

4. Section 308.2 is removed and reserved.
5. Section 308.5 is 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

6. The authority citation for Part 317 continues to read as
follows:

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

Sec. 317.21 [Amended]

7. Paragraph (b) of Sec. 317.21 is amended by removing the words
``an FSIS approved'' and adding, in their place, the word ``a''.

PART 318--ENTRY INTO OFFICIAL ESTABLISHMENTS; REINSPECTION AND
PREPARATION OF PRODUCTS

8. The authority citation for part 318 is revised to read as
follows:

Authority: 7 U.S.C. 138f; 7 U.S.C. 450, 1901-1906; 21 U.S.C.
601-695; 7 CFR 2.18, 2.53.

9. Section 318.4 is amended to read as follows:
a. Paragraph (d) is revised;
b. The words ``or Partial Quality Control'' are removed from the
heading of paragraph (e);
c. Paragraph (e)(1) is amended by removing the words ``or (d)''
from the first sentence and both occurrences of the words ``or partial
quality control program'' in the second sentence;
d. Paragraph (e)(2) is amended by removing the words ``or program''
from the first and second sentences;
e. Paragraph (e)(3) is amended by removing the words ``or partial
quality control program'' from the first sentence;
f. The words ``or Partial Quality Control'' are removed from the
heading of paragraph (g);
g. Paragraph (g)(1) is amended by removing the words ``or a partial
quality control program'' and paragraph (g)(2) is amended by removing
the words ``or partial quality control program''; and
h. Paragraph (g)(3) is revised.
The amendments and revisions read as follows:

Sec. 318.4 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 required
to have 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) This 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

[[Page 45025]]

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) This quality control program shall ensure that the product,
operation, or part of an operation which it concerns is in control and
that applicable product or label limits are being met. Process control
is to be determined by generally recognized statistical process control
procedures.
(e) Evaluation and Approval of Total Plant Quality Control. (1) The
Administrator shall evaluate the material presented in accordance with
the provisions of paragraph (c) of this section. If it is determined by
the Administrator, on the basis of an evaluation, that the total
quality control system will result in finished products controlled in
this manner being in full compliance with the requirements of the Act
and regulations thereunder, the total quality control system will be
aproved and plans will be made for implementation under departmental
supervision.
(2) In any situation where the system is found by the Administrator
to be unacceptable, formal notification shall be given to the applicant
of the basis for the denial. The applicant will be afforded an
opportunity to modify the system in accordance with the notification.
* * * * *
(3) The establishment owner or operator shall be responsible for
the effective operation of the approved total plant quality control
system to assure compliance with the Act and regulations thereunder.
The Secretary shall continue to provide the Federal inspection
necessary to carry out his responsibilities under the Act.
(f) * * *
(g) Termination of Total Establishment Quality Control.
(1) The approval of a total plant quality control system may be
terminated at any time by the owner or operator of the official
establishment upon written notice to the Administrator.
(2) The approval of a total plant quality control system may be
terminated upon the establishment's receipt of a written notice from
the Administrator under the following conditions:
(i) * * *
(ii) * * *
(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.
* * * * *
10.-11. Section 318.7 is amended to read as follows:
a. Paragraphs (b)(3)(i) and (b)(3)(ii) of Sec. 318.7 are revised;
and
b. 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'' is
revised.
The revisions 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) that results 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) that
results in compliance with this provision.
* * * * *
(c) * * *
(4) * * *

----------------------------------------------------------------------------------------------------------------
Class of substance Substance Purpose Product Amount
----------------------------------------------------------------------------------------------------------------
* * * * * *
*
Miscellaneous................... Ascorbic acid, To delay Fresh beef cuts, Not to exceed,
erythorbic acid, discoloration. fresh lamb cuts, singly or in
citric acid, and fresh pork combination, 500
sodium ascorbate cuts. ppm or 1.8 mg/sq
and sodium inch of product
citrate, singly surface of
or in combination ascorbic acid (in
under quality accordance with
control. 21 CFR 182.3013),
erythorbic acid
(in accordance
with 21 CFR
182.3041), or
sodium ascorbate
(in accordance
with 21 CFR
182.3731); and/or
not 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).
* * * * * *
*
----------------------------------------------------------------------------------------------------------------

* * * * *

Sec. 318.19 [Amended]

12. Paragraph (e) of Sec. 318.19 is amended in the first sentence
by removing the words ``total'' and ``partial quality control''.

Sec. 318.308 [Amended]

13. Paragraph (b) of Sec. 318.308 is amended by removing the words
``an approved'' and ``program'' and paragraph (c) is amended by
removing ``and submitted to the Administrator for approval''.
14. Paragraph (a) of Sec. 318.309 is amended by removing the words
``an approved'' and ``program'' and paragraphs (b) and (c) of
Sec. 318.309 is amended by removing ``and submitted to the
Administrator for approval''.

PART 319--DEFINITIONS AND STANDARDS OF IDENTITY OR COMPOSITION

15. The authority citation for Part 319 continues to read as
follows:

Authority: 7 U.S.C. 450, 1901-1906; 21 U.S.C. 601-695; 7 CFR
2.18, 2.53.

16. Section 319.5 is amended by revising the first two sentences of
paragraph (e)(2) to read as follows:

[[Page 45026]]

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 an establishment quality control system.
* * * * *

Sec. 319.104 [Amended]

17. The last sentence in footnote 3 to the chart in Sec. 319.104 is
amended by removing the words ``approved by the Administrator under
Sec. 318.4 of this subchapter.''

Sec. 319.105 [Amended]

18. The last sentence in footnote 2 to the chart in Sec. 319.105(a)
is amended by removing the words ``approved by the Administrator under
Sec. 318.4 of this subchapter.''

PART 327--IMPORTED PRODUCTS

19. The authority citation for Part 327 continues to read as
follows:

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

20. Paragraph (d) of Sec. 327.6 is revised to read as follows:

Sec. 327.6 Products for importation; program inspection, time and
place; application for approval of facilities as official import
inspection establishment; refusal or withdrawal of approval; official
numbers.

* * * * *
(d) Approval for Federal import inspection shall be in accordance
with part 304 of this subchapter.
* * * * *

PART 331--SPECIAL PROVISIONS FOR DESIGNATED STATES AND TERRITORIES;
AND FOR DESIGNATION OF ESTABLISHMENTS WHICH ENDANGER PUBLIC HEALTH
AND FOR SUCH DESIGNATED ESTABLISHMENTS

21. The authority citation for Part 331 continues to read as
follows:

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

22. Paragraph (a) of Sec. 331.3 is revised to read as follows:

Sec. 331.3 States designated under paragraph 301(c) of the Act;
application of regulations.

* * * * *
(a) Each establishment located in such a designated State, shall be
granted inspection required under Sec. 302.1(a)(2) of this subchapter
only if it is found, upon a combined evaluation of its premises,
facilities, and operating procedures, to be capable of producing
products that are not adulterated or misbranded.
* * * * *

PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS

23. The authority citation for Part 381 continues to read as
follows:

Authority: 7 U.S.C. 138f; 7 U.S.C. 450, 1901-1906; 21 U.S.C.
451-470; 7 CFR 2.18, 2.53.

24. Section 381.19 is revised to read as follows:

Sec. 381.19 Application for inspection; irradiation facilities.

All applicants for inspection whose operations include irradiation
and other processing shall submit, to the Administrator, a proposed
quality control system as provided in Sec. 381.149 of this part.
25. Section 381.20 is revised as follows:

Sec. 381.20 Survey and grant of inspection.

(a) Before inspection is granted, FSIS shall survey the
establishment to determine if the construction and facilities of the
establishment are in accordance with the regulations. FSIS will grant
inspection, subject to Sec. 381.21, when these requirements are met.
(b) FSIS shall give notice in writing to each applicant granted
inspection and shall specify in the notice the establishment, including
the limits of the establishment's premises, to which the grant
pertains.
26. Section 381.53 is amended by removing paragraphs (a)(2) through
(a)(5) and paragraph (b); redesignating paragraphs (c) through (m) as
paragraphs (b) through (l), respectively; and redesignating paragraph
(a)(1) as paragraph (a) and revising it 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 component ingredient shall
comply with 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, ensure 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]

27. Paragraph (b) of Sec. 381.121d is amended by removing the words
``an FSIS approval'' and adding, in their place, the word ``a''.
28. Section 381.145 is amended to read as follows:
a. Paragraph (d) of Sec. 381.145 is revised;
b. The words ``Programs or'' are removed from the heading of
paragraph (e);
c. Paragraph (e)(1) is amended by removing the words ``or (d)''
from the first sentence and both occurrences of ``, partial quality
control program,'' from the second sentence;
d. Paragraph (e)(2) is amended by removing the words ``or program''
from the first and second sentences;
e. Paragraph (e)(3) is amended by removing ``, partial quality
control program,'' from the first sentence;
f. The words ``Programs or'' are removed from the heading of
paragraph (g);
g. Paragraph (g)(1) is amended by removing the words ``or a partial
quality control program'';
h. Paragraph (g)(2) introductory text is amended by removing ``,
partial quality control program,'' and paragraph (g)(2)(ii) is amended
by removing the words ``or program'' from the first sentence; and
i. Paragraph (g)(3) is revised.
The amendments and revisions 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 poultry products who is required to
have 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) This 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

[[Page 45027]]

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) This quality control program shall ensure that the product,
operation, or part of an operation which it concerns is in control and
that applicable product or label limits are being met. Process control
is to be determined by generally recognized statistical process control
procedures.
(e) Evaluation and Approval of Quality Control Systems.
(1) The Administrator shall evaluate the material presented in
accordance with the provisions of paragraph (c) of this section. If it
is determined by the Administrator on the basis of an evaluation, that
the total quality control system will result in finished products
controlled in this manner being in full compliance with the
requirements of the Act and regulations thereunder, the total quality
control system will be approved and plans will be made for
implementation under departmental supervision.
(2) In any situation where the system is found by the Administrator
to be unacceptable, formal notification shall be given to the applicant
of the basis for the denial. The applicant will be afforded an
opportunity to modify the system in accordance with the notification.
* * * * *
(3) The establishment owner or operator shall be responsible for
the effective operation of the approved total plant quality control
system or quality control system for irradiation facilities to assure
compliance with the requirements of the Act and regulations thereunder.
* * * * *
(f) * * *
(g) Termination of Total Establishment Quality Control.
(1) The approval of a total plant quality control system may be
terminated at any time by the owner or operator of the official
establishment upon written notice to the Administrator.
(2) The approval of a total plant quality control system or quality
control system for irradiation facilities may be terminated upon the
establishment's receipt of a written notice from the Administrator
under the following conditions:
(i) * * *
(ii) If the establishment fails to comply with the quality control
system to which it has agreed after being notified by letter from the
Administrator or his designee.
* * * * *
(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.
* * * * *
29. Paragraph (a) of Sec. 381.222 is revised to read as follows:

Sec. 381.222 States designated under paragraph 5(c) of the Act;
application of regulations.

* * * * *
(a) Each establishment located in such a designated State, shall be
granted inspection required under Sec. 381.6(b) only if it is found,
upon a combined evaluation of its premises, facilities, and operating
procedures, to be capable of producing products that are not
adulterated or misbranded.

Sec. 381.308 [Amended]

30. Paragraph (b) in section 381.308 is amended by removing ``an
approved'' and ``program'' and paragraph (c) is amended by removing
``and submitted to the Administrator for approval''.

Sec. 381.309 [Amended]

31. Paragraph (a) of Sec. 381.309 is amended by removing the words
``an approved'' and ``program'' and paragraphs (b) and (c) of
Sec. 381.309 is amended by removing ``and submitted to the
Administrator for approval''.

Done, at Washington, DC, August 11, 1997.
Thomas J. Billy,
Administrator.

Note: The following appendices will not appear in the Code of
Federal Regulations.

Appendix A--Guidance on Establishment Facilities and Equipment

OVERVIEW

This Guidebook is intended for use by meat and poultry
establishments in considering decisions about design and construction
of their facilities, as well as the selection of equipment to be used
in their operations. The material that forms the basis for this
Guidebook is drawn principally from technical knowledge and experiences
used by the Food Safety and Inspection Service in making its prior
approval decisions about the acceptability of facilities and equipment.
The Agency is no longer making these prior approval decisions for
inspected establishments; however, the technical considerations on
which those decisions were based may be of interest to establishments
in the future. That is the material which is reflected in this
Guidebook.

Chapter 1

LOCATION

Selecting the location for your establishment is an important
factor in providing a sanitary environment for producing meat and
poultry products. When selecting a location, you will need to consider
the physical environment of the site, accessibility, separation of your
premises from other businesses, common areas shared by you and other
establishments, and whether or not you will conduct uninspected
businesses such as retail stores or custom slaughter on or near your
premises. This chapter provides guidelines you may wish to consider
when the select a location for your establishment.

1. Site

The size of the site should allow for all buildings, parking lots,
access roads, and future expansion. The site should be large enough to
accommodate a potable water supply for your processing needs, and a
sewage system that can efficiently handle liquid waste and process
water created by your establishment. In addition, potential building
locations should be evaluated for sanitation hazards. In determining
that possibility, consider the following guidelines:
* To the extent possible, establishments should be located in areas
free of industries that attract vermin such as sanitary landfills and
junk yards.
* To the extent possible, establishments should be located in areas
free of odors and airborne particulate matter that may be produced by
neighboring industries or other outside sources, such as oil
refineries, trash dumps, chemical plants, sewage disposal plants,
dyeworks, and paper pulpmills.
* The prevailing winds are an important factor in site
determination because substances emanating from more distant sources
may be a problem if the winds carry them to the establishment site.

[[Page 45028]]

2. Separation of Official and Non-Official Establishments

Sometimes an establishment is located next to or in the same
building as other businesses which are not under FSIS inspection. In
those circumstances you should take great care to keep product from
becoming contaminated from the operation of the adjoining business.

Chapter 2

LAYOUT

One of the most important decisions you make in building or
modifying an establishment is how you plan the layout of your building,
including the placement of rooms and equipment, product flow and people
traffic patterns. Not only does a poorly designed establishment affect
your productivity, but it may result in congested operations that can
lead to unsanitary conditions. This chapter provides guidelines that
you may wish to consider in planning any modifications to your existing
establishment or in building a new one.

1. Flow of Operations

The direction in and means by which product moves or flows within a
plant is an important but often neglected consideration that can have
enormous influence on sanitation and the safety of finished products.
From a product flow standpoint, all raw meat and poultry products ought
to be considered as potentially microbiologically contaminated and
handled accordingly. Product being processed should flow progressively
from highest potential exposure to contamination to the least potential
exposure to contamination, with intervening processes designed to
remove or otherwise reduce the contaminants whenever possible. The flow
of air and people should be just the opposite, moving from the cleanest
areas progressively toward less clean areas.
When designing product flow, consider the following:
* Moving product from raw to final cooked product areas to
systematically reduce the risks of contamination along the way.
* Locating trash dumpsters and receptacles so that they do not
create a risk of product contamination.
* Selecting rooms large enough to permit the installation of all
necessary equipment with space for establishment operations and
inspection.
* Locating people passageways to provide maximum clearance to
products, work areas, and production equipment.
* Keeping truckways unobstructed.

2. People Traffic Flow

Inadequate control of the flow of people through product
operational areas is one of the most serious risks for production
contamination. People can act as carriers and bring from the outside
contaminants such as dirt, debris, and vermin which are ideal vectors
for microbiological growth and which can both directly and indirectly
contaminate product. Ways in which you can reduce and control the flow
of people include the following:
* Establishment design should not require personnel not routinely
assigned to specific work areas to be routed through those work areas.
For example, personnel working in the live animal areas should not be
required to travel through cooked product areas to use welfare rooms.
* Welfare rooms, such as toilet rooms, dressing (locker) rooms, and
cafeterias, should be designed to minimize contamination because of the
traffic patterns of the people.

3. Separation of Raw and Ready-to-Eat Product

Cross contamination of ready-to-eat product by raw products may
occur if the layout does not provide for separation of these products.
To prevent cross contamination in the preparation of products, the
following are guidelines for you to consider:
* Exposed cooked product areas should be physically separated from
other areas of the establishment. Non-pedestrian passage openings may
be present for the transfer of product or supplies.
* A ventilation system should be used to direct air flow away from
exposed cooked product areas.
* Environmental control equipment such as fans and evaporator
condensation pans should not be located above the product.
* Welfare rooms, dry storage, maintenance, box/carton make up,
packaging, and palletizing areas should be separate, but adjacent to,
the exposed cooked product rooms.
* Cooked product should be covered in rigid containers to protect
it from contamination while in storage.
* Separate coolers and/or freezers should be available to use for
exposed cooked product.
* All cooking apparatuses for exposed products should have separate
entry and exit portals.
* No cooked product wash or reconditioning sinks should be used.

4. Perishable Product Rooms

Special care should be taken in perishable product rooms to inhibit
growth of microorganisms in operations which could contaminate product.
In addition, care should be taken to prevent contamination from other
operations such as where raw ingredients are prepared. Non-meat or non-
poultry ingredients should be prepared in a room or rooms separate from
meat or poultry processing rooms. For example, preparation of raw
vegetables for use in product should be performed in a room separate
from meat or poultry processing rooms.

5. Edible and Inedible Products Rooms and Areas

Edible product can be easily contaminated by contact with inedible
products, grease or sewage from inedible product areas. In order to
prevent this contamination from occurring, consider the following in
the placement of these rooms:
* The flow of inedible and condemned product should be designed so
that it does not come into contact with edible product.
* An inedible products department should be separate and distinct
from the areas used for edible products. Inedible product rooms, grease
interceptors, and sewage treatment equipment must be located away from
edible product rooms.
* Hooded, closed chutes that lead directly from the slaughter room
to the inedible handling room are designed to prevent objectionable
odors from inedible and condemned products from entering edible
products rooms.
* If rendering facilities are not available at the establishment
watertight storage facilities should be provided to hold these products
before their removal to rendering plant. These storage facilities
should be separate and apart from edible products rooms, and
constructed to prevent unsanitary conditions including attraction or
harborage for vermin.
* Areas for inedible trucks should be paved and enclosed for ease
of cleaning and to control odors and vermin.
* Where necessary, the boiler room should be a separate room to
prevent dirt and objectionable odors entering from it into rooms where
meat products are processed or handled.

6. Byproducts for Use in Animal, Pet, or Fish Food

Establishments that process byproducts into animal, pet, or fish
food should provide rooms for decharacterizing, chilling, packaging, or

[[Page 45029]]

otherwise preparing the byproducts. Consider the following guidelines
when designing and constructing these rooms:
* Byproducts to be used as animal, pet, or fish food should be
stored separately to prevent cross contamination and commingling with
edible products.

7. Coolers and Freezers

Coolers and freezers need to have enough space to refrigerate and
store product. Product should be stored in a manner that will preclude
conditions which may lead to contamination of product. The following
guidelines will assist you in preventing conditions which could lead to
contamination of your product:
* Coolers and freezers, including doors, should be constructed of
materials that can be readily and thoroughly cleaned, and durable,
rigid, impervious to moisture, non-toxic, and non-corrosive. Freezer
doors should be constructed and installed to prevent accumulation of
frost.
* Coolers and freezers should be equipped with floor racks, pallets
or other means to ensure protection of product from contamination from
the floor.

8. Dry Storage

Packaging materials and ingredients should be stored to preclude
conditions which may lead to contamination of product. The following
are guidelines which may assist you in the planning of your dry storage
area:
* Dry storage materials should be stored in a room dedicated to dry
storage only.
* The dry storage area should be constructed so that racks can be
spaced away from the walls and passageways maintained between rows.
This facilitates cleaning of the area. In addition, the construction
should allow for all meat or poultry ingredients and/or packaging
materials to be stored in closed containers on racks or pallets.

9. Incubation Room for Canned Products

A room or incubator for incubating samples of fully-processed
canned meat or poultry must be provided in all establishments
conducting regular canning operations. Consider the following
guidelines when building this room:
* An accurate time/temperature recorder must be provided. To
prevent temperature variations, a means for air circulation should be
provided.
* Shelves should be provided to hold canned product. The shelves
should be made of expanded metal or heavy gauge wire mesh and be
removable for cleaning.
* The floor in the room should be pitched to a floor drain equipped
with a removable screw-plug.
* The door of the room should be equipped for sealing by the
inspector, if necessary.

10. Vehicular Areas Outside the Building

Special care should be given in the design of vehicular areas
outside your building, not only to provide room for trucks and other
vehicles to operate without damaging your building, but to prevent
unsanitary conditions which might contaminate product in your
establishment. You should consider the following in designing your
vehicular areas:
* Areas outside the building where vehicles are loaded or unloaded
should be paved with concrete or a similar hard surface. Hard surface
areas allow these areas to be kept clean and eliminate the potential
for water puddles or dust.
* Areas outside the building where vehicles are loaded or unloaded
should be drained. Drainage from the loading docks should be confined
to the immediate area of the dock.
* The vehicular areas should be large enough to accommodate the
turning radius of the largest trucks or shipping vehicles used by the
establishment.
* The vehicular areas adjacent to the establishment should have
hose connections for cleaning.

Chapter 3

WELFARE FACILITIES FOR ESTABLISHMENT EMPLOYEES

One source of potential contamination of product is cross
contamination from employee welfare facilities. In designing and
locating employee facilities, great care should be given to preventing
overcrowding and congestion and to providing enough handwash sinks and
toilets for your employees. This chapter provides additional guidelines
that you may wish to consider in making any modifications to or
building any welfare facilities for your employees.

1. Dressing (Locker) Rooms

Dressing rooms must be provided for employees. In addition to
privacy considerations, these dressing rooms should be located where
they will not be a potential source of cross contamination of product.
Consider the following guidelines for these dressing rooms:
* Dressing rooms should be separate from rooms or compartments
where product is prepared, stored, or handled.
* Dressing rooms should be separated from the toilet area.
* Separate dressing rooms should be provided for each sex if both
sexes are employed by the establishment.
* Dressing rooms should have abundant, well-distributed light of
good quality.
* Separate dressing rooms for raw product and other product
department employees will help prevent cross contamination of product.
* Receptacles for soiled clothing should be provided adjacent to
employees' dressing rooms.

2. Lockers

Lockers should be provided for employees clothing and personal
items. To prevent insanitary conditions, consider the following
guidelines when choosing the type of lockers and the arrangement and
locations for them:
* To prevent the potential for cross contamination, the location of
lockers should be separate from rooms or compartments where product is
prepared, stored, or handled.
* Lockers should be large enough to store a change of clothing and
other personal items.
* For ease of cleaning, lockers should be constructed of materials
that are rigid, durable, non-corrosive, easily cleaned and inspected,
impervious to moisture, a light, solid color, with a smooth or easily
cleaned texture, and have sloping tops.
* Lockers should either be installed so that there is enough room
under them that they can be easily cleaned and inspected, or they
should be sealed to the floor.

3. Drinking Fountains

Sanitary drinking water fountains should be provided. Consider the
following guidelines when installing drinking water fountains:
* Drinking water fountains should be provided at convenient
locations throughout the establishment to minimize the distance that
employees need to travel to reach a fountain. This is especially
important in preventing cross-contamination from employees working in
raw or inedible areas and traveling to processing or ready-to-eat areas
to use a fountain. Consider the following locations for placing
drinking fountains:
** welfare areas including cafeterias, dressing (locker) rooms, and
toilet rooms
** inspectors' offices
** edible product areas including kill floor, deboning, and cut-up
areas
** inedible product areas
** immediately outside freezers and coolers

[[Page 45030]]

** storage areas
* Drinking water fountains should be connected to the potable water
supply and either directly connected to the underfloor drainage system
or should discharge through an air gap to a hub drain.
* Drinking water fountains should be other than hand operated, and
if placed as part of handwash sink, should be located high enough to
avoid splash from the sink.

4. Toilet Rooms

Toilet rooms can easily become a source of potential contamination
of product. Care should be taken in the design of these rooms from
their location in the establishment's layout to the number of toilets
provided. Consider the following guidelines:
* Toilet rooms need to be separated from the rooms and compartments
in which products are prepared, stored, or handled.
* Toilet rooms that open directly into rooms where meat products
are exposed should have self-closing doors and should be ventilated to
the outside of the building.
* Toilet rooms should be arranged so they are entered through an
intervening dressing room or vestibule and not directly from a
production or storage room.

5. Eating Rooms and Areas

To prevent employees from contaminating products or contaminating
their food with microorganisms from the raw products or from their
working environment consider the following:
* Separate eating rooms or areas should be provided for employees.

6. Handwash Sinks

One of the most important steps you can take to prevent cross
contamination of product by your employees is to provide conveniently
located handwash sinks. Handwash sinks are needed in toilet rooms,
dressing (locker) rooms, and production rooms. Consider the following
guidelines when making decisions as to where you need a handwash sink:
* Handwash sinks are needed near toilet rooms and dressing (locker)
rooms. They should be other than hand operated. There should be hot and
cold running water, soap, and towels. Single use towels should be used.
* Handwash sinks in welfare rooms and areas should have a
combination mixing faucet delivering both hot and cold water with an
high enough above the rim of the bowl to enable the washing of arms as
well as hands.

7. Ventilation

In designing your welfare rooms, such as toilet and dressing rooms,
care should be taken to make sure that they are ventilated to prevent
odors from entering production areas. Consider the following
guidelines:
* Welfare rooms that are not air conditioned should be mechanically
ventilated through an exhaust fan taking air to the outside. Airflow
from welfare rooms should be released outside the establishment.
* Toilet and dressing rooms that are located where no natural
ventilation is available should be equipped with an exhaust fan
(activated by a common switch with the lighting in the area) and a duct
leading to the outside. Doors to dressing and toilet rooms ventilated
in this manner should have a louvered section about 12 inches by 12
inches minimum in the lower panel to facilitate airflow.

8. Employees Working in Inedible Product Areas

Association of employees working in inedible product areas with
other employees through common welfare rooms increases the risk of
cross-contamination of product. To minimize this risk to product,
consider the following guidelines:
* Separate welfare rooms for employees working in areas such as
hide cellars, condemned or inedible product rooms, or live animal
holding areas, from welfare rooms of other employees working with raw
or heat processed, exposed, edible product.

Chapter 4

CONSTRUCTION

A frequently overlooked area of construction design is the
selection of appropriate construction materials for the establishment.
This chapter provides guidelines for construction and the selection of
construction materials that you may wish to consider when making
modifications to your current establishment or building a new one.

1. Building Construction Materials for Rooms (Finished Surfaces)

Production and storage areas need to be constructed with materials
that are readily and thoroughly cleaned. Product in production and
storage areas is at risk for contamination from indirect contact with
materials used for construction of the building. In order to be readily
and thoroughly cleaned, building construction materials in production
and storage areas must be:
* Rigid and durable.
* Non-toxic and non-corrosive.
* Impervious to moisture.
* A light, solid color such as white.
* Smooth or textured with an easily cleaned, open pattern, for
example, a pattern where the veins and depressed areas are continuous
or have an outlet and are not enclosed.
In addition, consider the following guidelines for selecting
construction materials:
* In non-production and non-storage areas, building construction
materials should be easy to clean thoroughly.
* Special consideration should be given before using wood as a
construction material.
** Wood is absorbent and can absorb not only water but other
substances including chemicals that create a risk for contamination of
meat or poultry products.
** Wood is easily damaged and may create wood particles (splinters)
that contaminate meat or poultry products.
** If wood is used as a construction material in exposed product
areas of the official establishment, it is recommended that the wood be
milled smooth and completely sealed with a coating to prevent the wood
from adulterating meat or poultry product. The coating should be able
to be readily and thoroughly cleaned durable, rigid, impervious to
moisture, non-toxic, and non-corrosive.
** The use of hot linseed oil to treat or coat wood in exposed
product areas is not recommended because it promotes the growth of
molds and fungi.

2. Floors

In addition to any obvious debris on a floor, product can become
contaminated by the flooring or microorganisms living in debris in tiny
crevices in the floor. In order to avoid these sources of
contamination, consider the following guidelines when selecting and
installing flooring in your establishment:
* Floors in areas where product is handled or stored should be
constructed of durable, easily cleanable materials, and be impervious
to moisture. Commonly used materials are concrete, quarry tile, brick,
and synthetic material.
* Floors should be installed and maintained to reduce the
likelihood of cracks, depressions, or other low areas that would
accumulate moisture.
* Floors where operations are conducted should have a slip-
resistant surface. Good results are obtained by using brick or concrete
floors with abrasive particles embedded in the surface. Concrete floors
should have a rough finish.

[[Page 45031]]

* Floors should be sloped to avoid puddles or depressions within
the slope where water will stand.

3. Coving/Curbs

Coving is used at the wall-floor juncture, column (post)--floor
juncture, and equipment support-floor juncture to provide a smooth
transition for ease of cleaning and inspection. Consider the following
guidelines when using coving or curbs:
* Coving in production and storage areas should include the
following criteria:
** All seams should be tight-fitting and sealed to eliminate all
cracks and crevices which may shelter insects, vermin, and
microorganisms.
** The coving should eliminate any sharp angles that allow the
accumulation of materials.
* Curbs should be provided to protect walls and wall finishes.
Curbs should be high enough to protect the walls from pallets, trucks,
or containers used in the establishment. Coving should be provided at
the base of the curb.

4. Stairs

In selecting stairs consider the following:
* Stairs should have solid treads and closed risers and should have
side curbs of similar material.

5. Catwalks and Access Platforms

When installing catwalks and access platforms consider the
following guidelines:
* Catwalks and access platforms in edible product handling
departments should be constructed of materials that meet the same
guidelines as flooring.
* Open grating should not be used for the flooring of catwalks and
access platforms inside the establishment, particularly in production
areas. Dirt and other debris from shoe soles can be scraped off by the
grating and contaminate product, packaging material, and equipment.
* Catwalks and access platforms should not be installed over
production lines and processing equipment.

6. Interior Walls Including Posts and Partitions

To prevent product from becoming contaminated by contact with
interior walls, care needs to be taken in selection of materials for
the finished surface of walls. Consider the following when selecting a
finish:
* Interior walls, in areas where product is stored or handled,
should be finished with materials that will make them susceptible to
being readily and thoroughly cleaned and impervious to moisture.
Examples of such materials are glazed brick, glazed tile, smooth
concrete, and fiberglass reinforced plastic (FRP).
* Walls should have a smooth texture, not one that is rough or
uneven.
* Fasteners for wall covering material should be solid, smooth
headed, and not have recesses which allows the collection of foreign
material.

7. Ceilings

Ceilings, in areas where product is stored or handled, should be
constructed to prevent the collection of dirt or dust that might sift
through from the areas above or fall from overhead collecting surfaces
onto equipment or exposed products. Therefore, it is recommended that
ceilings and overhead structures be maintained free of sealing paint or
plaster, dust, condensate, leaks, and other materials or defects. In
addition, ceilings in areas where product is stored or handled should
be constructed and finished with materials that can be thoroughly
cleaned and are moisture resistant. Examples of such materials are
smooth concrete and fiberglass reinforced plastic.

8. Windows and Skylights

Windows (and skylights) can be a potential source of contamination
of product by dirt, water, debris, or broken glass. Consider the
following when selecting and installing windows:
* All outside windows, except for those in receiving and feed
rooms, should have protection to exclude insects, birds, and other
vermin.
* Window ledges should be sloped about 45 degrees to prevent the
accumulation of dirt, water, or debris.
* To avoid damage to window glass from impact of hand trucks and
similar equipment, the sills should be at least 3 feet above the floor.
* Windows that are installed in walls in exposed product rooms
should have panes of acrylic or polycarbonate plastic or other shatter-
proof material.

9. Doorways and Doors (General)

Doors are barriers that allow the movement of product and people,
but also present a barrier to contamination such as dirt, insects, and
other vermin as well as the microbiological hazards that they carry.
The door type, construction material, and room in which the door is
located are all important considerations when doors are installed in
the establishment. Doors are important in maintaining sanitary
conditions especially in production and storage areas. In production
and storage consider the following guidelines for doors:
The most effective doors have the following characteristics:
* They are impervious to moisture.
* They are tight fitting to minimize air exchange and to prevent
the entry of insects and vermin into the establishments.
* They are self-closing and used throughout the establishment,
especially in areas where toilet rooms open directly into rooms where
meat and poultry are exposed, to prevent contamination of products with
odors and their associated contaminants.
* They are high and wide enough to allow the movement of exposed
product through the doorways without it coming into contact with the
door or jamb.
* They are rigid and durable, and the junctions at jambs, walls,
and floors are sealed to eliminate all cracks and crevices for debris,
insects, and dirt to collect.
* Doors that open directly to the outside of the building from
production rooms should have an intervening closed space, such as a
vestibule or enclosed lock, to prevent the direct access of
contaminants and microbial organisms to areas inside the establishment.

10. Types of Doors

In selecting a type of door for your establishment you need to
consider the location of the door and whether or not product will be
traveling through it. The following guidelines for different types of
doors may be useful to you when selecting a door:
* The horizontal double-swinging, impact door is a bi-parting,
inflexible panel door with plastic windows (vision panels) that swings
only in the horizontal plane. If you select this door, consider the
following:
** This door may be useful in rooms with dimensions that would not
permit the use of a roll-up, vertical sliding or horizontal sliding
door.
** Because this door must be manually opened, the door can be
damaged creating sanitation and maintenance problems.
* The horizontal sliding door (manual and automatic) is a single or
bi-parting, inflexible door that moves only in the horizontal plane. If
you select this door, consider the following:
** This door may be useful in rooms with dimensions that would not
permit the use of a roll-up or vertical sliding door.
** The automatic opening option is recommended not only for
sanitation reasons, but it also prevents damage.
* The vertical sliding door (manual or automatic) is a single,
inflexible panel door that moves only in the

[[Page 45032]]

vertical plane. If you select this door, consider the following:
** This door may be useful in rooms with dimensions that would not
permit the use of a roll-up or horizontal sliding door.
** The automatic opening option is recommended not only for
sanitation reasons, but it also prevents damage.
* The overhead garage-type door (manual or automatic) is a hinged,
multi-paneled door that moves from the vertical to the horizontal
plane. If you select this door, consider the following:
** This door may be an excellent choice for sheds or buildings used
to store equipment, such as a lawn mower, that is used for the outside
maintenance of the establishment's property.
** It is recommended that these types of doors not be used in
exposed product areas or areas subject to wet clean-up because these
doors have spaces between the panels that allow the collection of
product, such as meat and fat, as well as contaminants.
* The roll-up door (manual or automatic) is a single flexible panel
door that moves only in the vertical plane and when open, coils tightly
onto a drum assembly. If you select this door, consider the following:
** This door can be an excellent alternative especially where space
for opening a door is limited.
** Several additional features should be installed on this type of
door to make it an effective barrier against contamination.
* The air curtain or air door is a door that uses a layer of air
generated by mechanical fans to separate two rooms or areas. If you
select this door, consider the following:
** This door needs to be carefully selected, installed, and
maintained to be effective.
** If an air imbalance (pressure imbalance) develops at the door
opening, the separation effect may be diminished or eliminated. Air
imbalance can occur from air flow changes from any other openings in
the rooms especially other doors.
** The movement of the air can stir up contaminants, such as dirt
and dust, if the area around the door is not kept clean.

Chapter 5

LIGHTING, VENTILATION, REFRIGERATION, AND EQUIPMENT

Controlling the manufacturing environment is important in
maintaining a sanitary environment in meat and poultry operations. This
chapter provides guidelines concerning lighting, ventilation,
refrigeration, and equipment for meat and poultry establishments that
you should consider in building or modifying an establishment.

1. Lighting

Well-distributed, good-quality artificial lighting is needed at all
places where natural light is unavailable or insufficient. Lighting is
critical to maintaining a sanitary environment for slaughter and
processing operations. Without adequate lighting, insanitary conditions
are often difficult to see and correct. When selecting and installing
lighting systems, consider the following requirements:
* Light fixtures in rooms where exposed meat or poultry is handled
should ensure maximum safety, to preclude contamination of products
with broken glass and prevent the collection of dirt, product, and
debris on lamp surfaces, including fixture surfaces not easily cleaned
or inspected.
* Lighting must be intense enough to allow both the establishment
and inspection personnel to see insanitary conditions and product
contamination. The intensity of lighting is measured in foot candles.
The following charts provide recommendations for minimum foot candles
for artificial lighting:

Table 1.--Guidelines for Minimum Lighting Intensity in Meat
Establishments
------------------------------------------------------------------------
30 ft. 50 ft.
Area candles candles
------------------------------------------------------------------------
General lighting (in areas where animals are
killed, eviscerated, and products are processed
or packaged)..................................... X
Offal cooler...................................... X
Carcass coolers................................... X
Freezers.......................................... X
Dry storage....................................... X
Ante-mortem inspection............................ X
Suspect pen inspection area....................... ......... X
Inspection stations............................... ......... X
Establishment quality control inspection areas.... ......... X
Reconditioning and reinspection areas............. ......... X
All other areas................................... X
------------------------------------------------------------------------

Table 2.--Guidelines for Minimum Lighting Intensity in Poultry
Establishments
------------------------------------------------------------------------
30 ft. 50 ft. 200 ft.
Area candles candles candles
------------------------------------------------------------------------
Ante-mortem inspection................. X
Inspection station (traditional)....... ......... X
Inspection station (NELS/SIS/NTI)...... ......... ......... X
Pre and post chill inspection areas.... ......... ......... X
Reconditioning and reinspection areas.. ......... ......... X
Establishment quality control
inspection areas...................... ......... ......... X
All other areas........................ X
------------------------------------------------------------------------

2. Ventilation

There should be enough ventilation for all areas of the
establishment including workrooms, processing, packaging, and welfare
rooms to ensure sanitary conditions. A good ventilation system is
important to the production of wholesome meat and poultry products.
Without controlling the quality of the air coming into the
establishment, products may become contaminated with dust, insects,
odors, or condensation. When designing your ventilation systems, you
should consider the following guidelines:
* The ventilation system should be designed so that turbulence is
avoided. The longer the distance the air has to flow, the greater the
resistance the air encounters not only from static air, but from solid
objects such as walls, equipment, people, and product.
* The ventilation system should be designed with the size of the
establishment in mind. The larger the facility, the greater the volume
of air that must be moved.
* The ventilation system should be designed to compensate for
changes in outside temperature and humidity that cause condensation
problems within the establishment.
* Screens and filters should be used where needed to screen out
dust, odors, and insects brought in from the outside to prevent product
contamination.
* Mechanical ventilation should be used to bring in fresh air to
areas where natural ventilation is inadequate.
* Ventilation should prevent vapor formation, such as steam or fog,
that would affect sanitation or interfere with the inspector's ability
to perform inspection.

[[Page 45033]]

* When exhaust fans are installed, provision should be made to
provide enough outside make up air to prevent air from being drawn into
and through docks, coolers, and production areas to the area served by
the exhaust fan.

3. Equipment (General Design and Construction)

Equipment materials should comply with 21 CFR, Parts 170-190 of the
Food and Drug Administration (FDA) regulations for direct food contact.
Equipment and utensils used for handling as preparing edible
product or ingredient in any official establishment should be easily
cleaned and not be a source of contamination. Consider the following
guidelines when selecting equipment.
* All direct product contact surfaces should be smooth; maintained
free of pits, cracks, crevices and scale; corrosion and abrasion
resistant; non-absorbent; shatterproof; nontoxic; and not capable of
migrating into food products.
* Equipment should not be painted on areas in or above the direct
product contact area.
* Construction materials that are sources of contamination include
cadmium, antimony or lead as plating or the plated base material, lead
exceeding 5 percent in an alloy and enamelware and porcelain used for
handling and processing product.
* Equipment should be designed and installed in such a way that
foreign materials, such as lubricants, heat exchanger media,
condensate, cleaning solutions, sanitizers and other nonfood materials,
do not contaminate food products.
* Equipment is self-draining or designed to be evacuated of water.
* All product contact surfaces allow contact with cleaning
solutions and rinse water.
* Clean-in-place (CIP) systems should have sanitation procedures
that are as complete and effective as those for cleaning and sanitizing
disassembled equipment. To remove all organic and inorganic residues,
CIP systems should meet the following criteria:
** Cleaning and sanitizing solutions and rinse water should contact
all interior surfaces of the system.
** The system should be self-draining, with no low or sagging
areas.
** The pipe interiors should be highly polished (120-180 grit)
stainless steel for easy inspection.
** Easily removable elbows with quick-disconnect mechanisms should
be installed at each change of direction. Elbows should be short enough
to permit verification that the interior has been cleaned.

Chapter 6

WATER SUPPLY

The water supply should be ample, clean, and potable with adequate
pressure and facilities for its distribution in the establishment and
its protection against contamination and pollution.

1. Potable Water

An adequate supply of fresh clean water is of primary importance in
plant operations. The first requirement is that the water supply to the
plant be potable or safe for human consumption or food processing. The
plant water supply must meet the potability standards in the National
Primary Drinking Water Regulations issued by the Environmental
Protection Agency (EPA).

2. Backflow

Public health officials have long been concerned about cross-
connections that may permit backflow in potable water supply
distribution systems. Cross-connections may appear in many forms and in
unsuspected places. Reversal of pressure and flow in the water system
may be unpredictable. Plumbing cross-connections between a potable and
nonpotable water supply may constitute a serious public health hazard.
There are numerous cases where cross-connections have been responsible
for contamination of potable water and have resulted in the spread of
disease. These concerns, as they relate to meat and poultry plants,
deserve special attention. The problem is continual as potable water
and piping systems are installed, repaired, replaced, or extended.
Two basic types of hazard may be created in piping systems: the
solid pipe with valved connections and the submerged inlet. The solid
pipe connection is often installed to supply an auxiliary piping system
from the potable source. It is a direct connection of one pipe to
another pipe or receptacle. Solid pipe connections may be made
accidentally to waste disposal lines when it is incorrectly assumed
that the flow will always be in one direction. An example would be
connecting a line carrying used, nonpotable cooking water from a water
jacket or condenser directly to a waste line without an air gap (see
below). ``Backflow'' will occur with a submerged inlet if the pressure
differential is reversed without an air gap. Submerged inlets are
created when the outflow end of a potable water line is covered with
water or other liquid. The other liquid may not be potable. Submerged
inlets could be created by a hose lying in a pool or puddle of water on
the floor.
Once a cross-connection exists, any situation that causes a
pressure differential with the potable line having the lower pressure
can result in contamination of the entire water distribution system and
potable water supply. This is called backflow and can be produced under
a variety of circumstances as illustrated below:
* Backsiphonage is one form of backflow. It is caused by negative
pressure in the delivery pipes of a potable water supply and results in
fluid flow in the reverse direction. It may also be caused by
at

[Text truncated at 120,000 characters. The full text is on the page linked above.]

---

Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A97-21882. Public record. Not legal advice.