[Federal Register Volume 62, Number 164 (Monday, August 25, 1997)]
[Rules and Regulations]
[Pages 45016-45044]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-21882]



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Part II





Department of Agriculture





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Food Safety and Inspection Service



_______________________________________________________________________



9 CFR Part 304, et al.



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



9 CFR Part 303, et al.



Sanitation Requirements for Official Meat and Poultry Establishments; 
Proposed Rule

Federal Register / Vol. 62, No. 164 / Monday, August 25, 1997 / Rules 
and Regulations

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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.

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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:
    <diamond> 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.
    <diamond> 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.
    <diamond> 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 
atmospheric pressure exerted on a pollutant liquid source that forces 
the pollutant into a potable water supply system that is under vacuum. 
The action in this case is the common siphon phenomenon. The negative 
pressure differential that will begin the siphoning action is a 
potential occurrence in any supply line.
    * Differential pressure backflow refers to a reversed flow because 
of backpressure other than siphonic action. Any interconnected fluid 
systems in which the pressure in one exceeds the pressure of the other 
may cause flow from one to the other because of the differential. This 
type of backflow is of concern in buildings where two or more piping 
systems are maintained. The potable water supply is usually under 
pressure from the city water main. Occasionally, a booster pump is 
used. The auxiliary system often is pressurized by a centrifugal pump, 
although backpressure may be caused by gas or steam pressure from a 
boiler. A reversal in differential pressure may occur when pressure in 
the potable system drops below that in the system to which the potable 
water is connected. The best method of preventing this type of backflow 
is the complete separation of the two systems and/or an air gap. Other 
safety methods involve the installation of mechanical backflow 
prevention devices. All methods require regular scheduled inspection 
and maintenance to ensure ongoing effectiveness of installed devices.
    Some areas that you should consider providing some form of 
protection from backflow and back siphonage include the following:
    * Water supply to pens for wash down or livestock watering.
    * Water supply to compressor cooling systems, cooling towers, and 
boiler rooms.
    * Water supply to cleanup systems, clean in place (CIP) systems, 
etc.
    * Water supply to hose connections.

[[Page 45034]]

    Various mechanical antibackflow devices are available to prevent 
backflow into a potable water supply system. Generally, the selection 
of the type and number of fail-safe devices should be based upon the 
degree of hazard from contamination. Additional considerations include 
piping size, location, and the need to test periodically the backflow 
devices to ensure proper operation.
    There are six basic types of devices that can be used to correct 
cross-connections:
    * Air gap
    * Barometric loops
    * Vacuum breakers--both atmospheric and pressure type
    * Double check valves with intermediate atmosphere vent
    * Double check valve assemblies
    * Reduced pressure principal backflow preventers
    * Specific requirements concerning backflow can be found in local 
building and board of health codes.

Chapter 7

GENERAL PLUMBING FACILITIES

    One of the most important factors to consider in the design and 
modification of establishments is the plumbing system. If the plumbing 
system is not properly installed, contamination of products can occur 
from flooding, back siphonage, stoppages and cross-connections with the 
potable water system. This chapter provides guidelines concerning the 
plumbing facilities, in meat and poultry establishments. For additional 
information on the design and modification of plumbing facilities, 
consult the National Plumbing Code.

1. Hose Connections and Hoses

    There should be enough conveniently located hose connections with 
steam and water mixing valves or hot water connections provided 
throughout the establishment for cleaning purposes. Hose connections 
are important in promoting routine cleaning of the establishment. 
Consider the following guidelines when determining how many hose 
connections, location of hose connections, and storage of hoses:
    * The number of hose connections depends on the number of drains.
    * If a shut-off nozzle is provided on the hose after the hot and 
cold water mixing valve, the vacuum breaker at the hose connection to 
the mixing valve will not work. Vacuum breakers should be installed on 
the hot and cold water supplies prior to the mixing valve to prevent 
such problems.
    * Hose connections should be provided with vacuum breakers to 
prevent back siphonage.

2. Establishment Drainage System

    There need to be efficient drainage and plumbing systems for the 
prompt removal of liquid and suspended solid wastes from the processing 
environment. Consider the following guidelines when designing or 
modifying your drainage system:
    * All plumbing should be sized, installed and maintained in 
accordance with applicable state and local plumbing codes, ordinances, 
and regulations.
    * Drainage lines should be located so that if leakage occurs, it 
will not affect product or equipment.

3. Floor Drains

    All parts of floors where operations are conducted should be well 
drained. There are two basic types of drains: point drains and trench 
drains. Point drains, the most commonly used drain in most areas, are 
located in strategic points in the room with the floor sloped toward 
the drain. The waste water flows over the surface of the floor until it 
reaches and is carried away by the drain. Trench drains involve a 
trough or trench that collects the waste from a larger area and directs 
the flow to a drain opening. The flooring is sloped toward the trench.
    In a typical plant, one four-inch (10.16 cm) drainage inlet is 
provided for each 400 square feet (37.16 square meters) of floor space. 
A slope of about one-quarter inch per foot (2.08 cm per meter) to 
drainage inlets is generally adequate to ensure proper flow with no 
puddling. In dry production areas, where only a limited amount of water 
is discharged on to the floor, an adequate slope may be about one-
eighth inch per foot (1.04 cm per meter). It is important that floors 
slope uniformly to drains with no low spots to collect liquid.
    * The location of floor drains depends upon many factors such as 
the type of task conducted in the space, the geometric shape of the 
area drained, truck traffic patterns, and equipment locations.
    * There are special drainage considerations in areas where there is 
a high volume of water usage. The water in trench drains should flow in 
the opposite direction of the product flow, for example, from the 
poultry evisceration to the picking areas.
    * All parts of floors where wet operations or where floors are to 
be frequently hosed down should be pitched to floor or trench drains.
    * Floor drains should not be located under equipment because it 
makes them inaccessible cleaning.
    * Rooms without floor drains such as dry storage, large finished 
product coolers, and distribution warehouses may prefer to use 
mechanical cleaning machines instead of installing drains. Examples of 
such cleaning devices are floor scrubbers and dry/wet vacuum machines.

4. Trap Seals

    Each floor drain should be equipped with a deep seal trap and 
vented properly to the outside. The purpose of such traps is to seal 
off the drainage system so that foul odors (sewer gases) cannot enter 
the plant. Effectiveness of the trap depends upon enough water 
remaining to constitute a seal. As water flows through the trap and 
down the drainpipe, suction is created that will pull the water out of 
the trap and break the seal unless the suction is broken by venting the 
drainpipe on the effluent side of the trap to the outside air. The seal 
can also be broken by evaporation of trapped water. This is not a 
problem in frequently used drains, but does occur where drains are 
seldom used.

5. Drainage Lines

    All drainage lines must comply with local code requirements. They 
should be installed and maintained to be leakproof. To prevent drainage 
lines from becoming entrances into the plant for pests, including rats 
and mice, all lines must be equipped with effective rodent screens. 
Secure drain covers, in addition to keeping out pests, also serve to 
prevent blockage of the traps and drainage lines with product scraps or 
other material too large to flow freely.

6. Cleanouts

    Cleanouts should be installed in the drainage system to prevent 
sewer blockages. Consider the following guidelines when installing 
cleanouts:
    * Cleanouts should be located so they are readily accessible, and 
can be used without constituting a threat of contamination to edible 
products.
    * To help avoid water puddling, cleanouts should be located on the 
``high lines'' of floor slopes and away from traffic patterns.

Chapter 8

ESTABLISHMENT SEWAGE TREATMENT

    The design and construction of sewage treatment facilities must 
comply with local code requirements. An improperly designed sewage 
system can contaminate the ground and water supply. This chapter 
provides

[[Page 45035]]

guidelines concerning sewage treatment at meat and poultry 
establishments that you may wish to consider in the installation of a 
sewage treatment facility.

1. Establishment Sewage Treatment

    Sewage, one the most dangerous sources of human pathogens, should 
never be allowed to come into contact with products, equipment, 
utensils, or any food contact surfaces. When installing an 
establishment sewage treatment facility, consider the following 
guidelines:
    * The system should be large enough to handle the amount of sewage 
that the establishment produces and accommodate future increases.
    * If a private septic tank, pre-treatment, or treatment system is 
used, it should be designed and operated to prevent contamination of 
products.
    * The sewage facility should be located away from product 
operations and ingredient and packaging storage areas.
    * An area for cleaning solid waste containers with hot water, 
drains, and curbing should be located near any solid waste disposal 
facility.

2. Grease Catch Basins or Interceptors

    Grease catch basins can be a source of contamination of products if 
not properly designed and located. Consider the following guidelines 
when constructing a grease catch basin:
    * Catch basins or interceptors for recovering grease should not be 
located in or near edible product departments or areas where edible 
products are shipped or received.
    * When a catch basin is located inside an establishment, it should 
be sealed with a gastite cover and located in a ventilated room.
    * Grease catch basins should be constructed so they can be 
completely emptied of their contents for cleaning.
    * The area surrounding an outside catch basin should be paved with 
impervious material, such as concrete, and drained.

Chapter 9

MEAT SLAUGHTER ESTABLISHMENTS

    Although the flesh of healthy livestock is practically sterile, 
when the animal is killed many factors can contribute to contamination 
of the carcass including improperly designed and constructed slaughter 
facilities. This chapter provides guidelines for meat slaughter 
facilities to consider in building or modifying slaughter facilities.
    Because different species of livestock need different slaughter 
facilities, this chapter is organized in the following way:
    * Sections 1 through 8 describe general guidelines for facilities 
that slaughter cattle, calves, sheep, goats, hogs, and equines.
    * Sections 9 through 37 describe additional guidelines for 
slaughter facilities as follows:
    * Sections 9 through 19 contain additional guidelines for cattle 
slaughter operations;
    * Section 20 contains additional guidelines for calf, sheep, and 
goat slaughter operations;
    * Sections 21 through 26 contain additional guidelines for hog 
slaughter operations; and
    * Section 27 contains additional guidelines for equine slaughter 
operations.

    Note: The guidelines in this chapter are in addition to Chapters 
1 through 8 which contain general guidelines which apply to all 
official meat and poultry establishments.

Meat Slaughter--General Facilities Guidelines

    The following guidelines apply to all establishments that slaughter 
cattle, calves, sheep, goats, hogs and equines. If you are building or 
modifying an establishment that slaughters these species, consider 
these facilities guidelines to prevent contamination of carcasses 
during slaughter operations.

1. Livestock Pens

    In addition to preventing contamination of the slaughter department 
and minimizing contaminates on the hides of the animals, proper design 
and construction of livestock pens prevent injury to the animals. 
Consider the following facilities guidelines when designing and 
constructing livestock pens:
    * Livestock pens should be located outside the slaughter department 
to prevent contamination of products from dust, odors, and other 
contaminates. If possible, the livestock pens should be separated from 
the department by full-height partitions of impervious material.
    * Livestock pens, driveways, and ramps should be free from sharp or 
protruding objects which could cause injury or pain to the animals.
    * Floors of the pens, ramps, unloading chutes, and runways should 
be constructed to provide good footing for livestock. Waffled floor 
surfaces and cleated ramps are effective construction designs.
    * Floors of the pens, ramps, unloading chutes, and runways should 
be sloped for drainage and cleaning.
    * Pen enclosures (except gateways) should be high and sturdy enough 
to prevent livestock from escaping.
    * Gates, fences, and chutes should have smooth surfaces that are 
easily cleaned.
    * Man gates or, if the walls are concrete, toe holds formed in the 
walls should be present to allow people to escape from pen enclosures 
in an emergency.
    * To help prevent livestock from slipping and falling on floors 
covered with excess water, thereby further contaminating their hides, 
water troughs should be provided with overflows located above or 
adjacent to pen floor drains.
    * Hose connections should be provided for cleanups.
    * Covered pens should be provided to protect crippled or downer 
animals from adverse climatic conditions. If held overnight, the pens 
should be large enough to allow the animals to lie down and have 
facilities for feed and water. Pens and driveways should be arranged so 
that sharp corners and direction reversals of driven animals are 
minimized.
    * A ``U.S. suspect'' or ``U.S. condemned'' pen should be available 
at all times and designed to allow for complete separation, including 
the drainage system, from other livestock.

2. Ante-mortem Inspection Areas

    Ante-mortem inspection areas should be designed and constructed to 
facilitate inspection and to prevent animals from being injured. 
Consider the following guidelines in designing and constructing these 
areas:
    * To avoid delays in slaughter operations, pens for ante-mortem 
inspection should have the capacity for holding the maximum number of 
animals of the various species that will be slaughtered in a single 
day.
    * To facilitate the ante-mortem inspection of animals, a separate 
suspect pen with a squeeze chute should be provided, where the 
temperature of the animals may be taken.
    * At least 50 percent of the livestock pen, including the area 
where the suspect pen and squeeze chute are located, should be under a 
weather tight roof to provide an area for proper ante-mortem inspection 
in inclement weather.
    * Special consideration should be given to designing ante-mortem 
inspection facilities to allow for humane transporting of crippled or 
downer animals into the slaughtering department. Because crippled and 
downer animals have difficulty moving,

[[Page 45036]]

special doorways and hoists to transport them to the stunning area 
should be provided.

3. Slaughter Area

    The slaughter area is one of the most difficult areas to keep 
sanitary because of the nature of slaughter operations. Consider the 
following guidelines in designing and constructing slaughter areas to 
minimize contamination of carcasses:
    * The slaughter area should be separated from the outside by a 
full-height partition or wall made of impervious material.
    * Any doors to the outside of the slaughter area should be self 
closing to minimize the risk of contamination, including contamination 
by vermin.
    * Slaughter areas should have floor space arranged to facilitate 
the sanitary conduct of operations and efficient inspection. For 
example, to prevent contamination of carcasses, truckways through which 
products are conveyed from the slaughter area to rooms such as the 
offal cooler, should be located so that the material is not trucked 
beneath rails from which dressed carcasses and products are suspended. 
For the same reason, personnel traffic should not move through lines of 
carcasses.

4. Stunning Areas Including Chutes and Alleys

    Stunning areas, chutes and alleys, should be designed to prevent 
congestion, injury to animals, and minimize contamination of hides 
which can lead to contamination of the carcasses. Consider the 
following guidelines when designing these facilities:
    * All pathways, chutes, and alleys leading to stunning areas, and 
the stunning areas, should be large enough for the species being 
slaughtered.
    * All pathways, chutes, and alleys leading to stunning areas, and 
the stunning areas, should be free from pain-producing restraining 
devices, sharp projections such as loose boards, exposed bolt ends, 
splintered or broken planking, protruding metal, and exposed wheels or 
gears.
    * All pathways, chutes, and alleys leading to stunning areas, and 
the stunning areas, should be free of unnecessary holes and openings 
where the animals' feet or legs may be injured.
    * Overhead gates should be covered at the bottom edge to prevent, 
injury to the animals.
    * Flooring should be constructed of roughened or cleated cement to 
reduce falls.
    * Stunning areas should be provided for confining animals for 
stunning before bleeding.
    * If ritualistic slaughter operations are conducted in the stunning 
area, shackles to confine the animals also should be provided.
    * When captive bolt stunners are used, the stunning areas should be 
designed and constructed to limit the free movements of animals so that 
the operator can locate the stunning blow with a high degree of 
accuracy.
    * When electrical stunning is used, the stunning area should be 
constructed so that any power activated gates will not cause injury to 
the animals.

5. Rail Arrangement and Truckways

    To prevent contamination of carcasses, rails should be arranged to 
provide enough room for carcasses to move without touching equipment, 
walls, columns, other fixed parts of the building, and other carcasses. 
Consider the following guidelines when arranging rails in your 
establishment:
    * Consideration should be given to the type of rail and the rail 
speed when determining how rails are to be arranged.
    * Trim rails should be arranged so that carcasses pass the final 
carcass inspection position after the final trim.
    * To prevent the carcass from becoming contaminated by debris on 
the floor and from splashes during cleanups, the cooler rails should 
provide for clearance from the lowest part of the carcass to the 
highest point of the floor.
    * A room or area for washing gambrels, hooks, and trolleys should 
be provided. The room or area should have an exhaust fan in an outside 
wall to dispense steam.

6. Viscera Separation and Edible Byproducts Refrigeration

    Because edible organs and parts (offal) are handled at temperatures 
conducive to bacterial growth, care must be taken in providing 
facilities for separation of viscera and for refrigeration of edible 
byproducts to prevent them from becoming contaminated. Consider the 
following guidelines for holding edible by products:
    * Facilities, such as viscera trucks or pans, should be provided 
for separating and handling viscera of the various species of animals 
to prevent commingling.
    * To prevent cross contamination, a separate cooler or a separately 
drained part of a carcass cooler should be provided for holding edible 
organs and parts (offal) under refrigeration.
    * To convey the edible byproducts to a cooler, a truck with 
removable metal drip pans should be provided.
    * To prevent cross contamination, establishment and inspection 
personnel from the slaughter department should be able to access the 
edible byproduct cooler without passing through a line of carcasses or 
through a congested carcass cooler.

7. Carcass Washing

    Special facilities for washing inspected carcasses are needed to 
remove bone dust and other accidental contamination from the carcass. 
Consider the following guidelines when designing and constructing this 
area:
    * A separately drained area or an area that is sloped to a floor 
drain should be provided where inspected carcasses are washed.
    * If the carcasses are washed manually by establishment personnel, 
a platform should be provided to allow establishment personnel to be 
able to reach all parts of the carcass.

8. Retain Room/Compartment

    * A retain room, cage, compartment, or receptacle may be required 
by inspection. Depending on the needs of inspection, consider the 
following guidelines for designing and constructing this room:
    * The retain room or compartment must be equipped for locking or 
sealing.
    * The room or compartment needs to be marked conspicuously ``U.S. 
Retained.''
    * If the retain compartment is located in the cooler, the 
compartment should be separated from the remainder of the cooler to 
prevent cross-contamination of inspected and passed carcasses. The 
separation can be accomplished by creating a compartment constructed of 
partitions of corrosion resistant wire screen or flat expanded metal.

Cattle--Additional Facilities Guidelines

    In addition to the guidelines (sections 1 through 8) for all 
establishments that slaughter livestock, the guidelines in the 
following sections 9 through 19 apply to establishments that slaughter 
cattle.

9. Cattle Dressing Layout

    There are a number of different cattle dressing layouts that can be 
used in a cattle slaughtering operation. Depending on the number of 
animals slaughtered, rate of inspection, and number of inspectors, you 
should carefully consider your options for a layout for slaughter 
operations.

[[Page 45037]]

10. Rail Heights, Distances, and other Slaughter Area Dimensions

    To assist you in planning the layout of your slaughter area, the 
following is a chart for recommended distances including rail heights, 
rail distances, and other cattle slaughter area dimensions:

       Table 3.--Guidelines for Dis- tances in Cattle Slaughtering      
                             Establishments                             
------------------------------------------------------------------------
                                                           Horizontal   
               Item                 Vertical distance       distance    
------------------------------------------------------------------------
Bleeding rail (distance from rail  16 feet (4.9 m)     .................
 to point of application of                                             
 shackle to shackle foot--4 feet                                        
 (1.2 m)).                                                              
Dressing rails (trolley length--1  12 feet 3 inches    .................
 foot 3 inches.                     (3.7 m)                             
  (.4 m))........................                                       
Beef cooler rails (trolley         11 feet (3.4 m)     .................
 length--1 foot 3 inches.                                               
  (.4 m))........................                                       
Moving equipment--heights of       ..................  .................
 conveyor rails, platforms, top                                         
 of viscera inspection table.                                           
Dry landing area in front of       ..................  7 by 8 feet (2.1 
 stunning pen.                                          by 2.5 m)       
Curb of bleeding area to pitch     ..................  5 feet           
 plates (no header rails).                               (1.5 m)        
Between header rail and carcass    ..................  6 feet           
 washing rail, if parallel.                              (1.8 m)        
Between header or washing rails    ..................  3 feet           
 and wall of slaughtering room.                          (.9 m)         
Between center lines of dressing   ..................  8 feet           
 beds.                                                   (2.5 m)        
Between moving top table and       ..................  5 feet 6 inches  
 dressing rail at inspector's                           (1.7 m)         
 platform.                                                              
Area for sterilizing viscera       ..................  7 by 8 feet (2.1 
 inspection truck.                                      by 2.5 m)       
------------------------------------------------------------------------
Note.--When rails are involved in horizontal distance measurements, the 
  distance is measured from the center of the rail. When rails are      
  involved in vertical distance measurements, the distance is measured  
  from the top of the rail to the highest part of the floor.            

11. Dry Landing Area

    A dry landing area large enough to accommodate stunned animals 
removed from the stunning pen should be provided adjacent to the 
stunning pen. Consider the following guidelines in designing and 
constructing this area:
    * The area should allow enough room for the livestock.
    * The dry landing area should be located and drained separately 
from the bleeding area.
    * The dry landing area should be enclosed by a fence high enough 
and sturdy enough to prevent escape of inadequately stunned animals.

12. Bleeding Area

    To contain blood and prevent it from contaminating carcasses, a 
curbed bleeding area should be provided. Consider the following 
guidelines in designing and constructing this area:
    * The bleeding area should be located so that blood will not be 
splashed on stunned animals lying in the dry landing area or on 
carcasses being skinned on the cradle beds, if they are used.
    * The curb around the bleeding area should be located far enough 
from the dressing bed or cradle to allow room for the carcasses to be 
maneuvered into the bed or cradle.

13. Facilities for Head Removal

    To avoid contamination of the carcasses from rumen contents, 
facilities for head removal need to be carefully designed:
    * Space should be provided for dehorning, flushing, washing, and 
inspecting heads; for storing heads on racks or trucks after removal 
from carcasses; and for head workup.
    * When a down hide puller is used, the head drop and head removal 
area should be curbed and drained.
    * A head wash cabinet should be provided.

14. Facilities for Hide Removal

    To limit contamination by hides, a hide chute should be provided 
near the point where hides are removed from carcasses. Consider the 
following guidelines when designing and constructing these facilities:
    * The chute should have a hood of sturdy rust-resistant metal with 
a push-in door closely fitting a metal frame inclined so as to be self-
closing. In order to evacuate airborne contaminants from hides such as 
scurf, dirt, spores, odors, and hairs, a vent pipe should extend from 
the hood vertically to a point above the roof.
    * Space needs to be provided between hide pulling and carcass 
evisceration to permit cervical inspection prior to viscera inspection.

15. Facilities for Feet and Udders

    Because of the high risk of contamination of carcasses from feet 
and udders which have been removed from carcasses, special facilities, 
such as a chute or slide, should be used for transferring these parts 
to containers. Consider the following guidelines for these facilities:
    * A chute or slide should be used to avoid splashing of milk or 
other contaminants onto the carcasses, floor, equipment, and personnel.

16. Foot Platforms

    Foot platforms installed for establishment employees performing 
various carcass dressing operations need to be carefully designed and 
installed to prevent contamination of carcasses. Consider the following 
guidelines:
    * If elevated foot platforms are used, they should be located so 
they do not touch skinned portions of the carcass.
    * If stationary platforms are used, they should be set far enough 
away from the dressing rail to prevent contact with the forelegs of 
cattle.
    * To provide space for operations and to prevent cross 
contamination by carcasses, push fingers or rail stops on powered 
conveyor or gravity flow rails should be spaced far enough apart to 
prevent contact between carcasses.

17. Viscera Trucks

    In establishments with a limited rate of slaughter, viscera are 
usually placed in a specially designed handtruck for inspection. 
Consider the following guidelines for use of viscera trucks:
    * For ease of cleaning, viscera trucks should be constructed of 
stainless or galvanized steel.
    * Viscera trucks should have an inspection pan and a lower viscera 
compartment.
    * When viscera trucks are used, a separately drained area should be 
available for washing and sterilizing such equipment.
    * To prevent contamination of products, the washing facilities 
should be located at or near the point where condemned products are 
discharged from the trucks. When placed where splash might contaminate 
edible products, the truck washing area should have walls high enough 
to contain any splash.

18. Moving-Top Inspection Tables

    In some establishments, viscera are placed on a moving-top table 
for inspection. These tables have special considerations as follows:
    * The table should be of a length that provides for evisceration, 
inspection, and viscera removal.

[[Page 45038]]

    * A continuous cleaning and sanitizing system should be available 
for the table.
    * To prevent contamination of products and the surrounding area, 
the viscera inspection table should have a drain under the table to 
prevent water from draining across the floor to other areas of the 
room.
    * To prevent contamination of carcasses, the foot platform, 
handwash sinks, hand tool disinfection unit (sterilizer), boot washing 
cabinet, and boot storage locker should be located alongside the 
loading end of the table.

19. USDA Post-mortem Inspection Station and Retain Rail

    Special facilities are needed for USDA post-mortem inspection for 
cattle. Consider the following provisions that must be met when 
designing these stations:
    * An inspection station consisting of 5 feet (1.5 m) of 
unobstructed line space for each head or carcass inspector.
    * When viscera tables are used, there must be 8 feet (2.5 m) for 
each viscera inspector on the inspector's side of the table needs to be 
provided.
    * A minimum of 50 foot candles of shadow-free lighting at the 
inspection surfaces of the head, viscera, and carcass.
    * A handwash sink (other than one which is hand operated), 
furnished with soap, towels, and hot and cold water, and located 
adjacent to the inspector's work area.
    * For each head and viscera inspector on cattle slaughter lines a 
sterilizer located adjacent to the inspector's work area.
    * For mechanized operations, a line control switch adjacent to each 
inspection station.
    * Facilities to position tally sheets or other recording devices, 
such as digital counters and facilities to contain USDA condemned 
brands.
    * Rail(s) for holding retained carcasses for final disposition 
along with platforms and handwash sinks. To prevent possible cross 
contamination, the retain rail must be long enough to prevent carcasses 
from touching.

20. Calves, Sheep, and Goats--Chart of Guidelines for Distances for 
Rails and Other Facilities

Table 4.--Guidelines for Distances in Calf, Sheep, and Goat Slaughtering
                             Establishments                             
------------------------------------------------------------------------
                                                          Horizontal    
              Item                 Vertical distance       distance     
------------------------------------------------------------------------
Bleeding rail for calves          11 feet (3.3 m)...  ..................
 (distance from top of rail to                                          
 point of application of shackle                                        
 to shackled foot--2 feet 6                                             
 inches (.8 m)).                                                        
Bleeding rails if only sheep or   9 feet-11 feet      ..................
 goats are slaughtered.            (2.7 m-3.4 m).                       
Dressing rail (trolley length--1  8 feet 6 inches     ..................
 foot (.3 m)).                     (2.6 m).                             
Cooler rails, calf carcasses      8 feet 6 inches     ..................
 (trolley length--1 foot (.3 m)).  (2.6 m).                             
Cooler rails, sheep or goat       7 feet 6 inches-8   ..................
 carcasses (trolley length--1      feet 6 inches                        
 foot (.3 m)).                     (2.3 m-2.6 m).                       
Moving equipment................  ..................  ..................
Vertical of rail to edge of       ..................  2 feet (.6 m)     
 viscera inspection stand.                                              
Length of rail from point of      ..................  6 feet (1.8 m)    
 evisceration to point where                                            
 carcass inspection is completed.                                       
------------------------------------------------------------------------
Note.--When rails are involved in horizontal distance measurements, the 
  distance is measured from the center of the rail. When rails are      
  involved in vertical distance measurements, the distance is measured  
  from the top of the rail to the highest part of the floor.            

Hogs--Additional Facilities Guidelines

    In addition to the general guidelines in sections 1 through 8, the 
following guidelines apply to those establishments that slaughter hogs. 
Consider these additional guidelines when building or modifying an 
establishment that slaughters hogs.

21. Livestock Pens

    * To prevent hogs from overheating, pens for hogs should have 
either a roof for shelter or a shower system to keep the animals cool 
in weather with temperatures greater than 70  deg.F (21  deg.C).

22. Location of Certain Operations

    * To prevent contamination, the following equipment and operations 
should be located in an area or areas separate from the carcass 
dressing area, except for the openings for access and passage of 
carcasses:
    ** Hoisting, sticking, and bleeding.
    ** Scalding vat.
    ** Dehairing machine located within a curbed area having 
nonclogging drainage outlet.
    ** Gambrelling table.
    ** Singeing operations.

23. Rail Arrangements for Hogs

    The following chart gives guidance for recommended distances for 
rails and other facilities for hog slaughter operations.

  Table 5.--Guidelines for Distances in Hog Slaughtering Establishments 
------------------------------------------------------------------------
                   Item                          Vertical distance      
------------------------------------------------------------------------
Bleeding rail to sticker's platform......  10 feet 6 inches (3.2 m).    
Extension of bleeding rail to top of       9 feet (2.7 m).              
 scalding vat.                                                          
Dressing rails \1\.......................  11 feet (3.3 m).             
Gambrels (suspending carcasses to floor    10 feet (3 m).               
 (1 foot (.3 m)).                                                       
Distances from rail to bottom of                                        
 inspection pans and various foot                                       
 platforms.                                                             
Rails in coolers for hog carcasses with    9 feet (2.7 m).              
 heads removed (1 foot (.3 m)).                                         
Rails to coolers for carcasses with heads  10 feet (3 m).               
 attached (1 foot (3 m)).                                               
Vertical of dressing rail to various foot                               
 platforms and widths of platforms .                                    
------------------------------------------------------------------------
\1\ Heads dropped but still attached.                                   
                                                                        
 Note.--When rails are involved in vertical distance measurements, the  
  distance is measured from the top of the rail to the highest part of  
  the floor.                                                            

24. Scalding

    To avoid contamination of the carcass, a scalding tank is used to 
remove hair and other contaminants.

[[Page 45039]]

Consider the following when installing a scalding tank:
    * A mechanical exhaust fan above the scalding tank will disperse 
steam.

25. Shaving, Singeing, and Carcass Washing

    * A shaving rail (throw-out rail) should be provided prior to the 
head dropping operation, so that unclean hogs can be removed from the 
dressing line for cleaning.
    * If a singer is used to remove hair, it should have an automatic 
cut off and starter switch to prevent the carcass from burning when the 
chain stops.
    * If a polisher is used, water sprays to clean the carcass of hair 
should be provided.
    * To remove hair from the hide which was missed by the scalder and 
dehairing process, a carcass washer should be located at a point after 
completion of shaving operations and before the head dropper's station.

26. Inspection Facilities

    Special facilities are needed for USDA post-mortem inspection for 
swine. Consider the following guidelines when designing these stations:
    * An inspection station consisting of 5 feet (1.5 m) of 
unobstructed line space for each head or carcass inspector must be 
provided.
    * When viscera tables are used, there must be 8 feet (2.5 m) for 
each viscera inspector on the inspector's side of the table needs to be 
provided.
    * A minimum of 50 foot candles of shadow-free lighting at the 
inspection surfaces of the head, viscera, and carcass must be provided.
    * A handwash sink (other than one which is hand operated), 
furnished with soap, towels, and hot and cold water, must be provided 
adjacent to the inspector's work area.
    * For each head inspector on swine slaughter lines, a sterilizer 
must be located adjacent to the inspector's work area.
    * For mechanized operations, a line control switch must be provided 
adjacent to each inspection station.
    * For swine slaughter lines requiring three or more inspectors, and 
for those one-and two-inspector configurations where the establishment 
installs a mirror, special facilities are needed. At the carcass 
inspection station one glass or plastic, distortion-free mirror, at 
least five by 5 feet (1.5 by 1.5 m), must be mounted at the carcass 
inspection station. The mirror should be mounted far enough away from 
the vertical axis of the moving line to allow the carcass to be turned, 
but not over 3 feet (90 cm) away, to allow any inspector standing at 
the carcass inspection station to readily view the back of the carcass.
    * Facilities to position tally sheets or other recording devices, 
such as digital counters and facilities to contain USDA condemned 
brands must be provided.

Equines--Additional Facilities

    In addition to the general guidelines in sections 1 through 8, and 
the guidelines for cattle in sections 9-19, if you plan to slaughter 
equines, such as horses, mules, donkeys, and ponies, the following are 
additional guidelines when building or modifying equine slaughter 
facilities.

27. Equine Slaughter Facilities

    * The facilities for equine slaughter establishments are 
essentially the same as those for slaughtering cattle. Exceptions 
include the following rail heights and clearances.

       Table 6.--Guidelines for Dis- tances in Equine Slaughtering      
                             Establishments                             
------------------------------------------------------------------------
                                                           Horizontal   
              Items                 Vertical distance       distance    
------------------------------------------------------------------------
Bleeding rail....................  18 feet (5.5 m)     .................
Dressing rails (trolley length--1  12 feet 6 inches    .................
 foot 3 inches (.4 m)).             (3.8 m)                             
Cooler rails (trolley length--1    12 feet 6 inches    .................
 foot 3 inches (.4 m)).             (3.8 m)                             
Cooler rails for carcasses in      8 feet 6 inches     .................
 quarters.                          (2.6 m)                             
Line of drop-offs to line of half  ..................  17 feet (5.2 m)  
 hoists.                                                                
Clearance between walls, posts,    ..................  3 feet           
 etc. and adjoining rails in                             (.9 m)         
 slaughter rooms and coolers.                                           
Curb of bleeding area to pritch    ..................  6 feet (1.8 m)   
 plates.                                                                
Dry landing area (minimum).......  ..................  7 by 8 feet (2.1 
                                                        by 2.5 m)       
------------------------------------------------------------------------
Note.--When rails are involved in horizontal distance measurements, the 
  distance is measured from the center of the rail. When rails are      
  involved in vertical distance measurements, the distance is measured  
  from the top of the rail to the highest part of the floor.            

Chapter 10

 POULTRY SLAUGHTER ESTABLISHMENTS

    Although the flesh of healthy living poultry is practically 
sterile, when the bird is killed many factors can contribute to 
contamination of the carcass including improperly designed and 
constructed slaughter facilities. This chapter provides guidelines for 
facilities for poultry slaughter establishments for you to consider in 
building or modifying your slaughter facilities. If you slaughter small 
animals such as rabbits or migratory fowl under voluntary inspection, 
use this chapter for guidance. See Chapters 1 through 8 for general 
information which applies to all official meat and poultry 
establishments.

1. Holding Sheds or Coops

    When building holding sheds or coops for poultry, consider the 
following guidelines:
    * A minimum of 30 foot candles of lighting must be provided to 
facilitate ante-mortem inspection.
    * The holding sheds should be weather tight.

2. Docks for Receiving and Hanging Live Poultry

    Consider the following guidelines to prevent dust, feathers, and 
other obnoxious substances from entering areas where edible products 
are being prepared, handled, or stored:
    * The live hanging dock needs to be physically separated from these 
areas. The separation should be accomplished by full height impervious 
walls with self-closing impervious doors, and openings limited to that 
necessary for poultry conveyor systems.

3. Slaughter Area

    Consider the following guidelines for the slaughter area to 
minimize risk of contamination to products:
    * The slaughter area (including stunning, bleeding, picking, 
scalding, and eviscerating operations) should be separated from those 
areas of the establishment where edible products are prepared or stored 
to minimize the risk of contamination.
    * The blood in the slaughtering area, especially the stunning and 
bleeding area, should be contained in as small an area as possible.

4. USDA Post-Mortem Inspection Station

    There are four systems of post-mortem inspection: Traditional 
Inspection, the Streamlined Inspection System, the New Line Speed 
Inspection System, and the New Turkey Inspection System. Each of the 
systems has mandatory requirements to minimize the risk of 
contamination to products and to promote efficient inspection. However, 
with the exception of the lighting requirements, there are no 
facilities guidelines for these post-mortem systems.

[[Page 45040]]

5. Facility Guidelines for Poultry Inspection Stations

    Note: There are no facility guidelines for Traditional Inspection 
System facilities except for lighting.

      Table 7.--Facility Guidelines for Poultry Inspection Stations     
------------------------------------------------------------------------
           Facility                  SIS          NELS           NTI    
------------------------------------------------------------------------
The conveyor line should be                                             
 level for the entire length                                            
 of the inspection station....            X             X             X 
The vertical distance from the                                          
 bottom of the shackles to the                                          
 top of the adjustable                                                  
 inspection platform, when it                                           
 is set in its lowest                                                   
 position, should be a minimum                                          
 of 60 inches (150 cm)........            X             X             X 
There should be a minimum of 8                                          
 feet (2.5 m) of space along                                            
 the conveyor line for one                                              
 inspection station and 16                                              
 feet (4.9 m) for two                                                   
 inspection stations..........            X                           X 
There should be a minimum of                                            
 42 feet (12.8 m) of space                                              
 along the conveyor line for                                            
 three inspection stations....                          X               
There should be a minimum of 6                                          
 feet (1.8 m) of space along                                            
 the conveyor line for the                                              
 establishment employee                                                 
 presenting the birds.........                          X               
There should be a minimum of 4                                          
 feet (1.2 m) of space for                                              
 inspector and a minimum of 4                                           
 feet (1.2 m) of space for the                                          
 establishment helper along                                             
 the conveyor line............            X             X             X 
There should be selectors or                                            
 ``kick-outs'' with birds on                                            
 shackles with 12 inch (30 cm)                                          
 centers (two inspection                                                
 stations on line)............            X                             
There should to be selectors                                            
 or ``kick-outs'' with birds                                            
 on shackles with 18 inch (45                                           
 cm) centers (three inspection                                          
 stations on line)............                          X               
A distortion-free mirror                                                
 should be located at each                                              
 inspection station which is:                                           
 at least 3 feet (.9 m) wide                                            
 and 2 feet (.6 m) high;                                                
 adjustable between 5 inches                                            
 (12.5 cm) and 15 inches (38                                            
 cm) behind the shackles;                                               
 positioned in relation to the                                          
 inspection platform so that                                            
 the inspector is positioned                                            
 opposite it 8 to 12 inches                                             
 (20.3 cm to 30.5 cm) from the                                          
 downstream edge; installed so                                          
 that guide bars do not extend                                          
 in front of the inspection                                             
 mirror; and illuminated by a                                           
 light which is positioned                                              
 above and slightly in front                                            
 of the mirror to facilitate                                            
 the illumination of the bird                                           
 and mirror surface...........                          X               
There should be a slip-                                                 
 resistant inspection platform                                          
 with a 42 inch (105 cm) high                                           
 rail on the back side and                                              
 with \1/2\ inch (4 cm) foot                                            
 bumpers on both sides and                                              
 front........................            X             X             X 
There should be an inspection                                           
 platform with a minimum                                                
 length of 4 feet (1.2 m) and                                           
 minimum width of 2 feet (.6                                            
 m)...........................            X             X             X 
There should be an adjustable                                           
 inspection platform that                                               
 easily and rapidly adjusts a                                           
 minimum of 14 inches (35 cm)                                           
 vertically while standing....            X             X             X 
A trough or other facilities                                            
 extending beneath the                                                  
 conveyor where processing                                              
 operations are conducted from                                          
 carcass opening to trimming                                            
 should be provided which is                                            
 wide enough to prevent                                                 
 trimmings, drippings, and                                              
 other debris from                                                      
 accumulation on the floor or                                           
 platform; and has enough                                               
 clearance between suspended                                            
 carcasses and the trough to                                            
 prevent contamination of                                               
 carcasses by splash..........            X             X             X 
A conveyor line stop/start                                              
 switch should be provided at                                           
 each inspection station                                                
 within easy reach of the                                               
 inspector....................            X             X             X 
A minimum of 200-foot candles                                           
 of shadow-free lighting with                                           
 minimum CRI value of 85,                                               
 which can be met by deluxe                                             
 cool fluorescent lighting,                                             
 must be provided.............            X             X             X 
Online hand rinsing facilities                                          
 with continuous flow water                                             
 withineasy reach should be                                             
 provided for each inspector                                            
 and establishment helper.....            X             X             X 
Online hand rinsing facilities                                          
 with continuous flow water                                             
 within easy reach must be                                              
 provided for each                                                      
 establishment presenter......                          X               
Receptacles for condemned                                               
 carcasses and parts should be                                          
 provided at each inspection                                            
 station......................            X             X             X 
Hang-back racks should be                                               
 provided and located within                                            
 easy reach for establishment                                           
 helpers......................            X             X             X 
------------------------------------------------------------------------

6. Facility Guidelines for Poultry Reinspection Stations

    Note: There are no guidelines for Traditional Inspection System 
facilities except for lighting.

     Table 8.--Facility Guidelines for Poultry Reinspection Stations    
------------------------------------------------------------------------
                                Prechill and     Reinspection stations  
                                  postchill  ---------------------------
                                reinspection                            
           Facility               stations                              
                               --------------     NELS           NTI    
                                     SIS                                
------------------------------------------------------------------------
There should be a minimum of 6                                          
 feet (1.8 m) of space along                                            
 the conveyor line for the                                              
 establishment presenter......                          X               
There should be a minimum of 3                                          
 feet (.9 m) of space along                                             
 each conveyor line and for                                             
 SIS after each chiller.......            X                           X 

[[Page 45041]]

                                                                        
A table for reinspecting                                                
 sample birds should be                                                 
 provided which is at least 2                                           
 feet (.6 m) wide, 2 feet (.6                                           
 m) deep, and 3 feet (.9 m)                                             
 high; readily cleanable; and                                           
 drainable....................            X                             
A table for reinspecting                                                
 sample birds should be                                                 
 provided which is at least 3                                           
 feet (.9 m) wide and 2 feet                                            
 (.6 m) deep; readily                                                   
 cleanable; and drainable.....                          X             X 
A space which is level and                                              
 protected from all traffic                                             
 and overhead obstructions                                              
 should be provided...........            X             X             X 
The vertical distance from the                                          
 bottom of the shackles to                                              
 floor needs to be a minimum                                            
 of 48 inches (120 cm) should                                           
 be provided..................            X             X             X 
A minimum of 200-foot candles                                           
 of shadow-free lighting with                                           
 a minimum CRI of 85 at the                                             
 table surface, which can be                                            
 met by deluxe cool white                                               
 fluorescent lighting, must be                                          
 provided.....................            X             X             X 
A separate clipboard holder                                             
 for holding the recording                                              
 sheets should be provided....            X             X             X 
Handwash sinks within easy                                              
 access of all persons working                                          
 at the station should be                                               
 provided.....................            X             X             X 
Hang-back racks should be                                               
 provided which are within                                              
 easy reach of all persons                                              
 working at the station, and                                            
 designed to hold 10 carcasses            X             X             X 
------------------------------------------------------------------------

7. Evisceration and Reprocessing Areas

    The evisceration area should be arranged to facilitate efficient 
sanitary operations and inspection. Consider the following guidelines 
when designing these areas:
    * Production lines should have drip pans installed beneath them, 
when these lines are located above areas such as walkways, 
truckways, work stations, and equipment, to prevent water, poultry 
products, or any other material from falling on the production areas 
below.
    * An area should be provided for a reprocessing station for the 
reconditioning of retained products including removal of 
contamination.

8. Inedible Offal

    In poultry establishments, the facilities for handling inedible 
offal should be designed to accommodate the size of the poultry 
being handled and to prevent the contamination of edible products. 
Consider the following guidelines when designing these areas:
    * The facilities, whether troughs or otherwise, should be large 
enough to allow clean and orderly removal of inedible offal during 
processing, without a pile up and without cross contamination of 
edible products.
    * The water rail for semi-dry poultry offal systems for young 
chickens should range from 34 to 36 inches (86 to 90 cm) in height 
above the standing surface and be positioned 7 to 10 inches (18 to 
26 cm) horizontally from the vertical line of the shackle.
    * The water rail for semi-dry poultry offal systems for turkeys 
should range from 34 to 36 inches (86 to 90 cm) in height above the 
standing surface and be positioned 13 to 15 inches (33 to 38 cm) 
horizontally from the vertical line of the shackle.
    * The floor gutter should be distinct, with vertical sides 
inside the post supporting the water rail (a minimum of 6 inches or 
15 cm is suggested to prevent workers feet from being in the 
gutter). Gutters should also be wide enough to catch all material 
dropping from the carcass.
    * Splash protectors should be installed at all points along the 
evisceration line where splashing of employees might occur.
    * Pipes for conveying offal should be constructed to permit 
daily cleaning and positioned so that sanitation will not be a 
problem, i.e., no pipes lying on the floor or bottom of a gutter.
    * Side walls of hoppers should be pitched to assure that 
material deposited in the hopper will slide to the point where the 
offal is being mechanically conveyed.

Chapter 11

 PLANT WASTE DISPOSAL

    Control and disposal of plant wastes are major concerns. Optimum 
use and reduction of waste are essential goals of economic production 
in all plants. From a plant sanitation standpoint, there are two vital 
concerns with waste disposal: (1) Plant waste contains most of the 
contaminants and disease-producing and product-spoiling microorganisms 
from the plant production processes; (2) plant wastes attract pests 
such as insects and rodents.

1. Organic Waste Disposal

    When disposing of organic wastes such as feathers, viscera, 
blood, and manure, the following guidelines should be considered:
    * Waste materials should not be allowed to accumulate on or near 
the premises.
    * Waste should be disposed of without creating insanitary or 
objectionable conditions.
    * Waste should be removed daily.
    * Holding bins should be cleaned before reuse and protected from 
insect and rodent harborage and infestations.

2. Rubbish Removal

    Rubbish, such as paper towels, cartons, office waste, and 
labeling materials, can become a sanitation problem. The following 
guidelines should be followed when removing rubbish:
    * Suitable containers should be conveniently located throughout 
the plant and emptied frequently.
    * The accumulation of rubbish before its removal should not 
cause a nuisance.
    * Plant refuse should be removed daily, or more often if 
necessary, to prevent a nuisance.

Appendix B--Guidelines for Developing Partial Quality Control 
Programs (PQC's)

Guidelines for Developing Partial Quality Control Programs Overview
    Quality control programs are essential to the proper functioning of 
any meat or poultry processing establishment. Processors have found 
quality control is good business because it can reduce costs, control 
product uniformity, and ensure that proper standards are being 
maintained throughout the production cycle. By increasing controls over 
raw ingredients, processes, and other variables, effective quality 
control systems can ensure compliance with company specifications and 
with the guidelines and requirements of the Department of Agriculture. 
Although in-plant inspectors have a role in the oversight of these 
programs, quality control is a management function and plant management 
should develop and implement effective quality control plans specific 
to their process and products.
    There are many approaches plants can take to ensure quality 
control. Some plants do not take any special measures during 
production, and changes are made only on finished product. Some plants 
incorporate preventive measures, such as product testing, during 
processing, and others undertake a series of specific actions to 
prevent mistakes and to ensure that products meet consumer 
expectations. Whether

[[Page 45042]]

limited or comprehensive, a quality control system should be in the 
written record of the plant. As experience is gained, the record 
keeping system may be improved by focusing on ``hot spots'' which are 
responsible for the major problems, revising specifications, or 
upgrading them to include sensitive testing devices, for example.
    Proper documentation of plant activities will become increasingly 
important in a HACCP inspection environment. Proper documentation of 
any in-plant process can save time and money and result in fewer 
mistakes by the establishment. The degree and complexity of the records 
depend on the scope of the processing operation; completeness of the 
records is also a reflection of management commitment to quality 
control.
    Plant or corporate management support is the key to a successful 
quality control program. Plant personnel will sense a lack of 
commitment to quality if management support is not apparent.
    Good quality control managers do not necessarily have to use 
complex, expensive methods to ensure control. Experience has shown that 
successful establishments function smoothly by paying close attention 
to the basics, documenting the process when it is running smoothly and 
when problems occur, and making necessary corrections as quickly as 
possible.

Chapter 1. Introduction

    Title 9 of the Code of Federal Regulations at Parts 318.4(d) and 
381.145(d) require Federal meat and poultry processing plants to 
establish and maintain written records for each critical check or 
critical control point and make the records available to FSIS 
inspection personnel upon request.
    * Although the regulatory requirement for FSIS to review and 
approve PQC programs has been rescinded, the new regulatory 
requirements in 318.4(d) and 381.145(d) provide information to plants 
about the necessary steps they must take to meet the new record keeping 
requirements in a Pathogen Reduction and HACCP inspection environment.
    * FSIS will continue to provide guidance to establishments to 
ensure that their Partial Quality Control (PQC) programs for specific 
products and processes are adequate to ensure product compliance with 
regulatory requirements. The information in this document is intended 
to be used as guidance material and is based on FSIS' experience and 
historical perspective reviewing and approving PQC programs.
    A few model PQC programs, representative of many products and 
processes, are presented below.

Chapter 2. Components of PQC Programs

    PQC programs should address four areas: (1) raw materials control; 
(2) process control; (3) records control; and (4) corrective/preventive 
action.

1. Raw Materials Control

    Raw materials control involves the receiving and stocking of only 
those materials that conform to established specifications. To ensure 
successful control of raw materials, establishments should consider the 
following:
    * To begin the development of a raw materials control procedure, 
plants should list each of the materials used to produce the product.
    * Once the list has been created, establishments should develop a 
receiving inspection procedure.
    * The procedure may address raw materials specifications, proper 
materials handling, proper storage, and disposal of nonconforming 
materials.
    * Materials should be routinely monitored to ensure they are 
meeting the established procedures.

2. Process Control

    Process control programs ensure continuous control of particular 
processes so that product standards will be met. Process control 
programs should meet the following criteria:
    * They should identify the products or processes to be controlled.
    * They should identify the control features necessary for product 
compliance.
    * They should establish control limits.
    * They should establish procedures for meeting the established 
limits.
    * They should provide monitoring procedures for ensuring that 
procedures are followed.
    An important aspect of process control is effective data collection 
and analysis. Process control programs should include sampling plans 
that permit reliable collection and analysis of data. After sampling 
plans have been developed, process limits can be established.
    * The limits established should be appropriate to ensure that 
quality standards will be met.
    * The limits established should be appropriate to ensure that meet 
regulatory or label limits for the product or process will be met.
    * Variation in materials, methods, processes, and products requires 
the setting of a tolerance for each quality standard. A tolerance limit 
is the total allowable deviation from an established standard. The 
limit allows for the normal variability which is inherent in any 
process.
    * Tolerance limits may need to be continuously adjusted to prevent 
problems.
    * Limits for certain processes have been established and used 
historically by industry; these limits are reflected in PQC programs 
previously approved by FSIS. The tolerances meet the intent of the 
requirements in 318.4(d) and 318.145(d)(2)(ii) and may continue to be 
used.
    * Establishments may elect to use these previously established 
tolerances or develop their own by following the requirements outlined 
in the regulation.

3. Records

    An important aspect of quality control is process documentation. 
Adequate records are essential to the system's capacity to provide the 
necessary controls. The records provide a history of the process and 
document when the process is working and when problems are occurring. 
The use of standard sheets, check-off forms, and other simple records 
is generally more successful than a complicated system. Charts and 
graphs already in use may be all that is necessary to document the 
system. The degree of record keeping and the complexity of the records 
depend, in large part, on the scope of the processing operation. In 
reviewing records, plant management should:
    * Look at those aspects of production most likely to cause 
problems. This procedure also can be useful in determining what 
critical checks need to be incorporated into a quality control program.
    * Correct problems as they occur. Proper documentation of the 
process can save time and money because it provides an establishment an 
opportunity to correct a problem before the finished product has been 
completed.

4. Corrective/Preventive Action

    Corrective action plans address the action to be taken when 
problems develop in a production process. Corrective action plans are 
essential components and important indicators of the strength of 
quality control programs. The primary emphasis of the plans should be 
on correction/prevention of problems in the production process. The 
type of plan used in a particular quality control program will be 
determined by the establishment and the processes conducted at the 
plant. Generally,

[[Page 45043]]

corrective action plans should include the following features:
    * They should provide for the identification of problems or 
deviations in processes.
    * They should provide for the identification of the causes of 
problems.
    * They should specify the corrective steps to be initiated and the 
criteria for determining how noncompliant products should be handled.
    * The plans should provide that corrective/preventive measures be 
implemented after a determination that no safety hazards exist.
    * The plans should provide for documentation of the corrective and 
preventive measures taken.

Models

    The following models are intended to be used as general guidelines 
to developers of quality control programs. They are not intended to be 
complete QC programs or a complete listing of all rotational QC 
programs but offer a framework and one approach to QC program 
development. In actual QC programs, details regarding tests, action 
criteria, corrective actions, and responsible personnel would reflect 
the specific process and establishment circumstances. Any 
specifications or limits cited are only examples and do not establish 
or imply Agency standards.
Model 1--Preparation of a PQC Program for the Addition of 10-Percent 
Solution to Poultry
Raw Material Control
    * Poultry--Chicken breasts will be received frozen, examined for 
condition, and immediately placed in the receiving dock freezer. 
(Specifications to be set by establishment.)
    * Dry ingredients--Upon receipt, the dry ingredients will be 
visually inspected for acceptance and immediately placed in the dry 
storage warehouse. (Specifications to be set by establishment.)
    * Corrective action--If either the poultry or the dry ingredients 
is found to be unacceptable, it will be tagged immediately and Quality 
Control will be notified. QC will evaluate and initiate appropriate 
product disposition.
    * Documentation--All critical checks and corrective actions will be 
recorded on the receiving log.
Process Control
    * Formulation control.
    ** Formulation control--A pumping solution will be formulated 
according to the label formulation. One ingredient of the solution will 
be weighed by a quality control technician for each batch. If an 
ingredient is found to be m0ore than 0.5 percent above or below the 
weight stated on the formula, the following will result: (1) the 
problem will be evaluated and the appropriate corrective action taken; 
(2) each ingredient of every batch will be checked until five 
consecutive batches are found to be in compliance.
    ** Documentation--All formulation check results and corrective 
actions, if needed, will be recorded on the formulation log.
    ** Scale accuracy control.
    *** Scale checks--All scales associated with the pumping operation 
will be verified for accuracy before operations begin. Scale accuracy 
will be checked against a known weight. If a scale is found to be 
inaccurate, it will not be used until it has been calibrated.
    *** Documentation--All scale check results and corrective actions, 
if required, will be recorded on the scale maintenance record.
Lotting
    * A lot will be defined as one shift's production; a sublot as 
approximately 500 pounds of product.
Added Solutions
    * Green weight determination--Each sublot will be identified with a 
unique code representing date and time of day the sublot is being 
produced.
    ** The sublot will be weighed before pumping.
    ** The identifying code and weight will be written on a tag, which 
will be attached to the combo bin containing the sublot.
    * Pumping--Every 30 minutes, 10 turkey breasts will be selected 
from a sublot before it is pumped. The 10 turkey breasts will be 
weighed, then passed through the pumping machine. The turkey breasts 
will be allowed to drain for 5 minutes, then weighed again.
    ** Tolerances--Each pump check will not be more than 0.5 percent 
over the target pump of 10 percent. If a pump check is found to exceed 
the tolerance, all product back the last pump check will be retained 
and allowed to drain until it reaches the target pump. In addition, the 
pumping operations will be stopped, evaluated by a QC technician, and 
not allowed to start until the problem has been corrected.
    ** Documentation--All pump checks and corrective actions, if 
needed, will be documented in the pumping log book.
    * Finished weight determination--After a sublot has been pumped, a 
final weight will be obtained and recorded on the pumping tag.
    ** Tolerances--No sublot will be more than 1.2 percent above the 
target pump of 10 percent. The average of all sublots will meet the 
target pump. If any sublot or the average of the sublots exceeds 
tolerances, all product will be retained and allowed to drain until the 
target pump has been reached.
    ** Documentation--All green weights, finished product weights, and 
corrective actions, if needed, will be recorded in the finished product 
log book.

    Note: Model also can be used in developing the following PQC 
programs:

Percent Labeling Control
Water-misted/Ice-glazed Meat and Poultry Products
Addition of Solution to Raw/Cooked Meat and Poultry Products 
(Injection, Massaging, Tumbling, Basting, Marination, and 
Tenderization)
Fat and/or added water for Raw Product
Model 2.. Preparation of a PQC Program for Fat-Content-per-Serving 
Labeling for Meat and Non-Meat Products
Scales/Meters
    * Establish verification procedures to ensure that all scales/
meters used in the formulation and analytical testing of the product 
are accurate. The procedure should include checks against a standard 
weight or measurement.
Lotting
    * Define lot and sublot.
    * Establish a standardized procedure for identifying the lot 
throughout the process.
Formulation
    * Establish a procedure to verify the formulation of each lot/
sublot in compliance with the approved label formulation.
    * Establish tolerances for non-restricted ingredients.
    * No ingredient in the formulation should be substituted for 
another.

Fat content of the meat portion (ground beef, ground pork, or products 
with a declared fat limit on the label)

    * Establish a statistically sound sampling procedure for each lot/
sublot of the meat portion.
    * Identify the analytical method used, such as an AOAC method. 
Weight Control (serving and component).
    * Establish a statistically sound sampling procedure to ensure that 
each portion and component of the product within a lot/sublot is 
checked against the label transmitted.
    * Raw weights--The weight is checked on all portions and components 
on finished raw and cooked products.
    * Cooked weights--Cooked weights are checked and compared with the 
portion size stated on the transmittal

[[Page 45044]]

and on the Child Nutrition (CN) label. Weights also are checked for 
precooked components of products against information on the label 
transmittal.
    * The sampling plans and tolerances should be based on generally 
recognized statistical process control methods and should ensure that 
the process is in control and that applicable product or label limits 
are being met.
    * Each CN product should have its own lot average.
Batter and Breading (if applicable)
    * Establish a procedure to verify that the batter/breading 
application does not exceed regulatory limits, label declarations, or 
product standards. The monitoring procedure should identify the 
following:
    ** pre-batter/breading application weight
    ** sample size
    ** sample frequency
    ** post-batter/breading application weight
    * Post-batter/breading weight should be determined at the end of 
the application procedure and before further processing. Note: Model 
also can be used in developing the following PQC programs:
    Batter and Breading
    FES Labeling Content for Meat and Non-Meat Products
    Precooked Breakfast Sausage Yield Control
Model 3. Low Temperature Rendering for the Production of Partially 
Defatted Chopped (P.C.) Beef/Pork, Fat-Reduced Species, and Partially 
Defatted Beef/Pork Fatty Tissue
Raw Materials Control
    * Define a lot and sublot
    * If producing P.C. beef/pork or fat-reduced species, establish a 
statistically based sampling procedure to ensure the lot is in 
compliance with raw material requirements (12 percent lean).
Heat Processing
    * Identify processing temperature (minimum and maximum).
    * Identify the target processing time, which is the time the 
product is subjected to the target.
    * Establish procedures for monitoring processing temperatures and 
times.
Cooling and Freezing Controls
    * Identify the cooling and freezing temperatures for the finished 
product.
    * Identify the amount of time the cooling and freezing process will 
take to reach established temperatures.
Microbiological
    * If the cooling/freezing process (starting from the time heat is 
applied until the product is 40 degrees F for less) exceeds 30 minutes, 
a microbiological sampling procedure should be developed. The following 
sampling procedures and limits have been used in PQC programs in the 
past, and current regulations permit their continued use.
    ** Using a statistically based sampling plan, select two samples 
per lot from the raw material and finished products.
    ** Test samples for total plate count, coliforms, E. coli, and  C. 
Perfringens.
    ** Demonstrate that the process does not increase the product's 
microbial load by 1 log or more.
    ** Sampling can be reduced to one per lot when control has been 
demonstrated in three consecutive lots.
Finished Product Controls
    * If producing finely textured lean or finely textured extra lean, 
product should be tested for fat, protein, and protein efficiency ratio 
(PER) or essential amino acid (EAA).
    * Incorporate the sampling procedure for fat and protein.
    ** Individual--Obtain a one-pound sample from each lot. After 10 
consecutive analyses are in compliance with single sample limits, 
sampling may be reduced to one randomly sampled lot out of every three 
lots.
    ** Process Average--A process (moving) average of 10 lots should be 
maintained.
Sampling Procedures for PER/EAA
    * Initially, each lot should be held and tested until compliance 
has been established. Once compliance has been established in three 
consecutive lots, sampling may be reduced. Sampling frequency should 
begin with at least one sample per month until compliance has been 
established. When three consecutive samples are in compliance, the 
frequency may be reduced to one sample every three months.
    * Analytical Standard Limits

Finely Textured Lean Product

Individual;
    Fat--Maximum 30%
    Protein--Minimum 13%
Process Average:
    Fat--Maximum 30%
    Protein--Minimum 14%
    PER 2.5 or
    EAA 33%

Finely Textured Extra Lean Similar Products

Individual:
    Fat--Maximum 11%
    Protein--Minimum 13%
Process Average:
    Fat--Maximum 10%
    Protein--Minimum 14%
    PER 2.5 or
    EAA 33%
Corrective and Preventive Actions
    * Develop corrective and preventive actions for each critical check 
point established.

    Note: Model also can be used in developing the following PQC 
programs:

Low Temperature Rendering for Control of Partially Defatted Chopped 
Beef/Pork
Fat-Reduced Species and Partially Defatted Beef/Pork Fatty Tissue

[FR Doc. 97-21882 Filed 8-22-97; 8:45 am]
BILLING CODE 3410-DM-P