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

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:

0583-0082, ``Meat and Poultry Inspection; Application for

Inspection, Sanitation, and Equipment Requirements and Exemptions'':

[[Page 45024]]

Establishments subject to inspection will no longer have to submit

blueprints and specifications along with Form FSIS-5200-5. The response

time is estimated to be 30 minutes, and there are 701 total burden

hours approved by the Office of Management and Budget (OMB) for this

activity. Therefore, FSIS will request OMB to remove the 701 approved

burden hours.

0583-0082, ``Meat and Poultry Inspection; Application for

Inspection, Sanitation, and Equipment Requirements and Exemptions'':

FSIS prior approval will no longer be required for the products of

equipment companies that are used in official establishments. The

response time is estimated to be 30 minutes for the prior approval of

equipment. There are 2,990 total burden hours approved by OMB for this

activity. Therefore, FSIS will request OMB to remove the 2,990 approved

burden hours.

0583-0089, ``Processing Procedures and Quality Control

Systems'': Establishments can continue to develop and implement PQC

programs according to Agency guidelines. These establishments, with the

exception of poultry irradiation facilities, are no longer required to

submit a letter requesting approval of a proposed PQC program and a

copy of the program to the Agency for approval prior to implementation.

The response time is estimated to be 30 minutes for writing the request

letter and sending the PQC program to FSIS. There are 600 total burden

hours approved by OMB for this activity. In consideration of poultry

irradiation facilities, 60 hours of burden will remain. FSIS does not

foresee more than two irradiation facilities requesting FSIS approval

of PQC programs. Therefore, FSIS will request OMB to remove 540

approved burden hours. The burden hours for PQC program development and

reporting remain the same.

List of Subjects

9 CFR Part 304

Drawings, Information to be furnished, Grant or refusal of

inspection, Meat inspection.

9 CFR Part 308

Meat inspection, Sanitation.

9 CFR Part 317

Meat inspection, Reporting and recordkeeping requirements.

9 CFR Part 318

Meat inspection, Establishment-operated quality control.

9 CFR Part 319

Food grades and standards, food labeling

9 CFR Part 327

Imports, meat inspection

9 CFR Part 381

Poultry and poultry products

For the reasons set forth in the preamble, FSIS is amending 9 CFR

Parts 304, 308, 317, 319, 327, and 381 of the Federal meat and poultry

inspection regulations, as follows:

PART 304--APPLICATION FOR INSPECTION; GRANT OR REFUSAL OF

INSPECTION

1. The authority citation for Part 304 continues to read as

follows:

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

2. Section 304.2 is amended by revising the heading; removing

paragraph (b); redesignating paragraphs (c) through (f) as paragraphs

(b) through (e), respectively; and revising paragraph (a), to read as

follows:

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

inspection.

(a) FSIS shall give notice in writing to each applicant granted

inspection and shall specify in the notice the establishment, including

the limits of the establishment's premises, to which the grant

pertains.

* * * * *

PART 308--SANITATION

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

follows:

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

Sec. 308.2 [Removed and reserved]

4. Section 308.2 is removed and reserved.

5. Section 308.5 is amended by removing ``, in the judgment of the

Administrator,'' from the first and third sentences of paragraph (a);

removing paragraphs (b) through (f); redesignating paragraph (g) as

(b); and revising the section heading to read as follows:

Sec. 308.5 Equipment and utensils to be easily cleaned; those for

inedible products to be so marked; PCB-containing equipment.

* * * * *

PART 317--LABELING, MARKING DEVICES, AND CONTAINERS

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

follows:

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

Sec. 317.21 [Amended]

7. Paragraph (b) of Sec. 317.21 is amended by removing the words

``an FSIS approved'' and adding, in their place, the word ``a''.

PART 318--ENTRY INTO OFFICIAL ESTABLISHMENTS; REINSPECTION AND

PREPARATION OF PRODUCTS

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

follows:

Authority: 7 U.S.C. 138f; 7 U.S.C. 450, 1901-1906; 21 U.S.C.

601-695; 7 CFR 2.18, 2.53.

9. Section 318.4 is amended to read as follows:

a. Paragraph (d) is revised;

b. The words ``or Partial Quality Control'' are removed from the

heading of paragraph (e);

c. Paragraph (e)(1) is amended by removing the words ``or (d)''

from the first sentence and both occurrences of the words ``or partial

quality control program'' in the second sentence;

d. Paragraph (e)(2) is amended by removing the words ``or program''

from the first and second sentences;

e. Paragraph (e)(3) is amended by removing the words ``or partial

quality control program'' from the first sentence;

f. The words ``or Partial Quality Control'' are removed from the

heading of paragraph (g);

g. Paragraph (g)(1) is amended by removing the words ``or a partial

quality control program'' and paragraph (g)(2) is amended by removing

the words ``or partial quality control program''; and

h. Paragraph (g)(3) is revised.

The amendments and revisions read as follows:

Sec. 318.4 Preparation of products to be officially supervised;

responsibilities of official establishments; establishment-operated

quality control.

* * * * *

(d) Partial Quality Control Programs. (1) Any owner or operator of

an official establishment preparing meat food products who is required

to have a quality control program for a product, operation, or part of

an operation shall make the written program and data and information

generated by the program available to Program employees.

(2)(i) This quality control program shall include, as appropriate

for the product, operation, or part of an operation which the program

concerns, detailed information on: raw material control, the critical

check or control points, the nature and frequency of tests to be made,

the charts and records that

[[Page 45025]]

will be used, the length of time such charts and records will be

maintained in the custody of the official establishment, the limits

which will be used and the points at which corrective action will be

taken to prevent recurrence of a loss of control, and the nature of the

corrective action--ranging from the least to the most severe.

(ii) This quality control program shall ensure that the product,

operation, or part of an operation which it concerns is in control and

that applicable product or label limits are being met. Process control

is to be determined by generally recognized statistical process control

procedures.

(e) Evaluation and Approval of Total Plant Quality Control. (1) The

Administrator shall evaluate the material presented in accordance with

the provisions of paragraph (c) of this section. If it is determined by

the Administrator, on the basis of an evaluation, that the total

quality control system will result in finished products controlled in

this manner being in full compliance with the requirements of the Act

and regulations thereunder, the total quality control system will be

aproved and plans will be made for implementation under departmental

supervision.

(2) In any situation where the system is found by the Administrator

to be unacceptable, formal notification shall be given to the applicant

of the basis for the denial. The applicant will be afforded an

opportunity to modify the system in accordance with the notification.

* * * * *

(3) The establishment owner or operator shall be responsible for

the effective operation of the approved total plant quality control

system to assure compliance with the Act and regulations thereunder.

The Secretary shall continue to provide the Federal inspection

necessary to carry out his responsibilities under the Act.

(f) * * *

(g) Termination of Total Establishment Quality Control.

(1) The approval of a total plant quality control system may be

terminated at any time by the owner or operator of the official

establishment upon written notice to the Administrator.

(2) The approval of a total plant quality control system may be

terminated upon the establishment's receipt of a written notice from

the Administrator under the following conditions:

(i) * * *

(ii) * * *

(3) If approval of the total establishment quality control system

has been terminated in accordance with the provisions of this section,

an application and request for approval of the same or a modified total

establishment quality control system will not be evaluated by the

Administrator for at least 6 months from the termination date.

* * * * *

10.-11. Section 318.7 is amended to read as follows:

a. Paragraphs (b)(3)(i) and (b)(3)(ii) of Sec. 318.7 are revised;

and

b. In the table in Sec. 318.7(c)(4) under the Class of substance

``Miscellaneous,'' the entry under the Substance ``Ascorbic Acid,

erythorbic acid, citric acid, sodium ascorbate, and sodium citrate'' is

revised.

The revisions read as follows:

Sec. 318.7 Approval of substances for use in the preparation of

products.

* * * * *

(b) * * *

(3) * * *

(i) 100 ppm ingoing (potassium nitrite at 123 ppm ingoing); and 500

ppm sodium ascorbate or sodium erythorbate (isoascorbate) shall be

used; provided that the establishment has a partial quality control

program as provided in Sec. 318.4(d) that results in compliance with

this provision, or

(ii) A predetermined level between 40 and 80 ppm (potassium nitrite

at a level between 49 and 99 ppm); 550 ppm sodium ascorbate or sodium

erythorbate (isoascorbate); and additional sucrose or other similar

fermentable carbohydrate at a minimum of 0.7 percent and an inoculum of

lactic acid producing bacteria such as Pediococcus acetolactii or other

bacteria demonstrated to be equally effective in preventing the growth

of botulinum toxin at a level sufficient for the purpose of preventing

the growth of botulinum toxin; provided that the establishment has a

partial quality control program as provided in Sec. 318.4(d) that

results in compliance with this provision.

* * * * *

(c) * * *

(4) * * *

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

Class of substance Substance Purpose Product Amount

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

* * * * * *

*

Miscellaneous................... Ascorbic acid, To delay Fresh beef cuts, Not to exceed,

erythorbic acid, discoloration. fresh lamb cuts, singly or in

citric acid, and fresh pork combination, 500

sodium ascorbate cuts. ppm or 1.8 mg/sq

and sodium inch of product

citrate, singly surface of

or in combination ascorbic acid (in

under quality accordance with

control. 21 CFR 182.3013),

erythorbic acid

(in accordance

with 21 CFR

182.3041), or

sodium ascorbate

(in accordance

with 21 CFR

182.3731); and/or

not to exceed,

singly or in

combination, 250

ppm or 0.9 mg/sq

inch of product

surface of citric

acid (in

accordance with

21 CFR 182.6033),

or sodium citrate

(in accordance

with 21 CFR

182.6751).

* * * * * *

*

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

* * * * *

Sec. 318.19 [Amended]

12. Paragraph (e) of Sec. 318.19 is amended in the first sentence

by removing the words ``total'' and ``partial quality control''.

Sec. 318.308 [Amended]

13. Paragraph (b) of Sec. 318.308 is amended by removing the words

``an approved'' and ``program'' and paragraph (c) is amended by

removing ``and submitted to the Administrator for approval''.

14. Paragraph (a) of Sec. 318.309 is amended by removing the words

``an approved'' and ``program'' and paragraphs (b) and (c) of

Sec. 318.309 is amended by removing ``and submitted to the

Administrator for approval''.

PART 319--DEFINITIONS AND STANDARDS OF IDENTITY OR COMPOSITION

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

follows:

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

2.18, 2.53.

16. Section 319.5 is amended by revising the first two sentences of

paragraph (e)(2) to read as follows:

[[Page 45026]]

Sec. 319.5 Mechanically Separated (Species).

* * * * *

(e) * * *

(2) A prerequisite for label approval for products consisting of or

containing ``Mechanically Separated (Species)'' is that such

``Mechanically Separated (Species)'' shall have been produced by an

establishment under an establishment quality control system.

* * * * *

Sec. 319.104 [Amended]

17. The last sentence in footnote 3 to the chart in Sec. 319.104 is

amended by removing the words ``approved by the Administrator under

Sec. 318.4 of this subchapter.''

Sec. 319.105 [Amended]

18. The last sentence in footnote 2 to the chart in Sec. 319.105(a)

is amended by removing the words ``approved by the Administrator under

Sec. 318.4 of this subchapter.''

PART 327--IMPORTED PRODUCTS

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

follows:

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

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

Sec. 327.6 Products for importation; program inspection, time and

place; application for approval of facilities as official import

inspection establishment; refusal or withdrawal of approval; official

numbers.

* * * * *

(d) Approval for Federal import inspection shall be in accordance

with part 304 of this subchapter.

* * * * *

PART 331--SPECIAL PROVISIONS FOR DESIGNATED STATES AND TERRITORIES;

AND FOR DESIGNATION OF ESTABLISHMENTS WHICH ENDANGER PUBLIC HEALTH

AND FOR SUCH DESIGNATED ESTABLISHMENTS

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

follows:

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

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

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

application of regulations.

* * * * *

(a) Each establishment located in such a designated State, shall be

granted inspection required under Sec. 302.1(a)(2) of this subchapter

only if it is found, upon a combined evaluation of its premises,

facilities, and operating procedures, to be capable of producing

products that are not adulterated or misbranded.

* * * * *

PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS

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

follows:

Authority: 7 U.S.C. 138f; 7 U.S.C. 450, 1901-1906; 21 U.S.C.

451-470; 7 CFR 2.18, 2.53.

24. Section 381.19 is revised to read as follows:

Sec. 381.19 Application for inspection; irradiation facilities.

All applicants for inspection whose operations include irradiation

and other processing shall submit, to the Administrator, a proposed

quality control system as provided in Sec. 381.149 of this part.

25. Section 381.20 is revised as follows:

Sec. 381.20 Survey and grant of inspection.

(a) Before inspection is granted, FSIS shall survey the

establishment to determine if the construction and facilities of the

establishment are in accordance with the regulations. FSIS will grant

inspection, subject to Sec. 381.21, when these requirements are met.

(b) FSIS shall give notice in writing to each applicant granted

inspection and shall specify in the notice the establishment, including

the limits of the establishment's premises, to which the grant

pertains.

26. Section 381.53 is amended by removing paragraphs (a)(2) through

(a)(5) and paragraph (b); redesignating paragraphs (c) through (m) as

paragraphs (b) through (l), respectively; and redesignating paragraph

(a)(1) as paragraph (a) and revising it to read as follows:

Sec. 381.53 Equipment and utensils.

(a) Equipment and utensils used for processing or otherwise

handling any edible poultry product or component ingredient shall

comply with applicable provisions of paragraphs (b) through (l) of this

section and otherwise shall be of such material and construction as

will facilitate their thorough cleaning, ensure cleanliness in the

preparation and handling of all edible poultry products, and avoid

adulteration and misbranding of such products. In addition to these

requirements, equipment and utensils shall not in any way interfere

with or impede inspection procedures. Receptacles used for handling

inedible products shall be of such material and construction that their

use will not result in adulteration of any edible product or in

unsanitary conditions at the establishment, and they shall bear

conspicuous and distinctive marking to identify them as only for such

use and shall not be used for handling any edible poultry products.

* * * * *

Sec. 381.121d [Amended]

27. Paragraph (b) of Sec. 381.121d is amended by removing the words

``an FSIS approval'' and adding, in their place, the word ``a''.

28. Section 381.145 is amended to read as follows:

a. Paragraph (d) of Sec. 381.145 is revised;

b. The words ``Programs or'' are removed from the heading of

paragraph (e);

c. Paragraph (e)(1) is amended by removing the words ``or (d)''

from the first sentence and both occurrences of ``, partial quality

control program,'' from the second sentence;

d. Paragraph (e)(2) is amended by removing the words ``or program''

from the first and second sentences;

e. Paragraph (e)(3) is amended by removing ``, partial quality

control program,'' from the first sentence;

f. The words ``Programs or'' are removed from the heading of

paragraph (g);

g. Paragraph (g)(1) is amended by removing the words ``or a partial

quality control program'';

h. Paragraph (g)(2) introductory text is amended by removing ``,

partial quality control program,'' and paragraph (g)(2)(ii) is amended

by removing the words ``or program'' from the first sentence; and

i. Paragraph (g)(3) is revised.

The amendments and revisions read as follows:

Sec. 381.145 Preparation of products to be officially supervised;

responsibilities of official establishments; establishment operated

quality control.

* * * * *

(d) Partial Quality Control Programs. (1) Any owner or operator of

an official establishment preparing poultry products who is required to

have a quality control program for a product, operation, or part of an

operation shall make the written program and data and information

generated by the program available to Program employees.

(2)(i) This quality control program shall include, as appropriate

for the product, operation, or part of an operation which the program

concerns, detailed information on: raw material

[[Page 45027]]

control, the critical check or control points, the nature and frequency

of tests to be made, the charts and records that will be used, the

length of time such charts and records will be maintained in the

custody of the official establishment, the limits which will be used

and the points at which corrective action will be taken to prevent

recurrence of a loss of control, and the nature of the corrective

action--ranging from the least to the most severe.

(ii) This quality control program shall ensure that the product,

operation, or part of an operation which it concerns is in control and

that applicable product or label limits are being met. Process control

is to be determined by generally recognized statistical process control

procedures.

(e) Evaluation and Approval of Quality Control Systems.

(1) The Administrator shall evaluate the material presented in

accordance with the provisions of paragraph (c) of this section. If it

is determined by the Administrator on the basis of an evaluation, that

the total quality control system will result in finished products

controlled in this manner being in full compliance with the

requirements of the Act and regulations thereunder, the total quality

control system will be approved and plans will be made for

implementation under departmental supervision.

(2) In any situation where the system is found by the Administrator

to be unacceptable, formal notification shall be given to the applicant

of the basis for the denial. The applicant will be afforded an

opportunity to modify the system in accordance with the notification.

* * * * *

(3) The establishment owner or operator shall be responsible for

the effective operation of the approved total plant quality control

system or quality control system for irradiation facilities to assure

compliance with the requirements of the Act and regulations thereunder.

* * * * *

(f) * * *

(g) Termination of Total Establishment Quality Control.

(1) The approval of a total plant quality control system may be

terminated at any time by the owner or operator of the official

establishment upon written notice to the Administrator.

(2) The approval of a total plant quality control system or quality

control system for irradiation facilities may be terminated upon the

establishment's receipt of a written notice from the Administrator

under the following conditions:

(i) * * *

(ii) If the establishment fails to comply with the quality control

system to which it has agreed after being notified by letter from the

Administrator or his designee.

* * * * *

(3) If approval of the total establishment quality control system

has been terminated in accordance with the provisions of this section,

an application and request for approval of the same or a modified total

establishment quality control system will not be evaluated by the

Administrator for at least 6 months from the termination date.

* * * * *

29. Paragraph (a) of Sec. 381.222 is revised to read as follows:

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

application of regulations.

* * * * *

(a) Each establishment located in such a designated State, shall be

granted inspection required under Sec. 381.6(b) only if it is found,

upon a combined evaluation of its premises, facilities, and operating

procedures, to be capable of producing products that are not

adulterated or misbranded.

Sec. 381.308 [Amended]

30. Paragraph (b) in section 381.308 is amended by removing ``an

approved'' and ``program'' and paragraph (c) is amended by removing

``and submitted to the Administrator for approval''.

Sec. 381.309 [Amended]

31. Paragraph (a) of Sec. 381.309 is amended by removing the words

``an approved'' and ``program'' and paragraphs (b) and (c) of

Sec. 381.309 is amended by removing ``and submitted to the

Administrator for approval''.

Done, at Washington, DC, August 11, 1997.

Thomas J. Billy,

Administrator.

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

Federal Regulations.

Appendix A--Guidance on Establishment Facilities and Equipment

OVERVIEW

This Guidebook is intended for use by meat and poultry

establishments in considering decisions about design and construction

of their facilities, as well as the selection of equipment to be used

in their operations. The material that forms the basis for this

Guidebook is drawn principally from technical knowledge and experiences

used by the Food Safety and Inspection Service in making its prior

approval decisions about the acceptability of facilities and equipment.

The Agency is no longer making these prior approval decisions for

inspected establishments; however, the technical considerations on

which those decisions were based may be of interest to establishments

in the future. That is the material which is reflected in this

Guidebook.

Chapter 1

LOCATION

Selecting the location for your establishment is an important

factor in providing a sanitary environment for producing meat and

poultry products. When selecting a location, you will need to consider

the physical environment of the site, accessibility, separation of your

premises from other businesses, common areas shared by you and other

establishments, and whether or not you will conduct uninspected

businesses such as retail stores or custom slaughter on or near your

premises. This chapter provides guidelines you may wish to consider

when the select a location for your establishment.

1. Site

The size of the site should allow for all buildings, parking lots,

access roads, and future expansion. The site should be large enough to

accommodate a potable water supply for your processing needs, and a

sewage system that can efficiently handle liquid waste and process

water created by your establishment. In addition, potential building

locations should be evaluated for sanitation hazards. In determining

that possibility, consider the following guidelines:

* To the extent possible, establishments should be located in areas

free of industries that attract vermin such as sanitary landfills and

junk yards.

* To the extent possible, establishments should be located in areas

free of odors and airborne particulate matter that may be produced by

neighboring industries or other outside sources, such as oil

refineries, trash dumps, chemical plants, sewage disposal plants,

dyeworks, and paper pulpmills.

* The prevailing winds are an important factor in site

determination because substances emanating from more distant sources

may be a problem if the winds carry them to the establishment site.

[[Page 45028]]

2. Separation of Official and Non-Official Establishments

Sometimes an establishment is located next to or in the same

building as other businesses which are not under FSIS inspection. In

those circumstances you should take great care to keep product from

becoming contaminated from the operation of the adjoining business.

Chapter 2

LAYOUT

One of the most important decisions you make in building or

modifying an establishment is how you plan the layout of your building,

including the placement of rooms and equipment, product flow and people

traffic patterns. Not only does a poorly designed establishment affect

your productivity, but it may result in congested operations that can

lead to unsanitary conditions. This chapter provides guidelines that

you may wish to consider in planning any modifications to your existing

establishment or in building a new one.

1. Flow of Operations

The direction in and means by which product moves or flows within a

plant is an important but often neglected consideration that can have

enormous influence on sanitation and the safety of finished products.

From a product flow standpoint, all raw meat and poultry products ought

to be considered as potentially microbiologically contaminated and

handled accordingly. Product being processed should flow progressively

from highest potential exposure to contamination to the least potential

exposure to contamination, with intervening processes designed to

remove or otherwise reduce the contaminants whenever possible. The flow

of air and people should be just the opposite, moving from the cleanest

areas progressively toward less clean areas.

When designing product flow, consider the following:

* Moving product from raw to final cooked product areas to

systematically reduce the risks of contamination along the way.

* Locating trash dumpsters and receptacles so that they do not

create a risk of product contamination.

* Selecting rooms large enough to permit the installation of all

necessary equipment with space for establishment operations and

inspection.

* Locating people passageways to provide maximum clearance to

products, work areas, and production equipment.

* Keeping truckways unobstructed.

2. People Traffic Flow

Inadequate control of the flow of people through product

operational areas is one of the most serious risks for production

contamination. People can act as carriers and bring from the outside

contaminants such as dirt, debris, and vermin which are ideal vectors

for microbiological growth and which can both directly and indirectly

contaminate product. Ways in which you can reduce and control the flow

of people include the following:

* Establishment design should not require personnel not routinely

assigned to specific work areas to be routed through those work areas.

For example, personnel working in the live animal areas should not be

required to travel through cooked product areas to use welfare rooms.

* Welfare rooms, such as toilet rooms, dressing (locker) rooms, and

cafeterias, should be designed to minimize contamination because of the

traffic patterns of the people.

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

Cross contamination of ready-to-eat product by raw products may

occur if the layout does not provide for separation of these products.

To prevent cross contamination in the preparation of products, the

following are guidelines for you to consider:

* Exposed cooked product areas should be physically separated from

other areas of the establishment. Non-pedestrian passage openings may

be present for the transfer of product or supplies.

* A ventilation system should be used to direct air flow away from

exposed cooked product areas.

* Environmental control equipment such as fans and evaporator

condensation pans should not be located above the product.

* Welfare rooms, dry storage, maintenance, box/carton make up,

packaging, and palletizing areas should be separate, but adjacent to,

the exposed cooked product rooms.

* Cooked product should be covered in rigid containers to protect

it from contamination while in storage.

* Separate coolers and/or freezers should be available to use for

exposed cooked product.

* All cooking apparatuses for exposed products should have separate

entry and exit portals.

* No cooked product wash or reconditioning sinks should be used.

4. Perishable Product Rooms

Special care should be taken in perishable product rooms to inhibit

growth of microorganisms in operations which could contaminate product.

In addition, care should be taken to prevent contamination from other

operations such as where raw ingredients are prepared. Non-meat or non-

poultry ingredients should be prepared in a room or rooms separate from

meat or poultry processing rooms. For example, preparation of raw

vegetables for use in product should be performed in a room separate

from meat or poultry processing rooms.

5. Edible and Inedible Products Rooms and Areas

Edible product can be easily contaminated by contact with inedible

products, grease or sewage from inedible product areas. In order to

prevent this contamination from occurring, consider the following in

the placement of these rooms:

* The flow of inedible and condemned product should be designed so

that it does not come into contact with edible product.

* An inedible products department should be separate and distinct

from the areas used for edible products. Inedible product rooms, grease

interceptors, and sewage treatment equipment must be located away from

edible product rooms.

* Hooded, closed chutes that lead directly from the slaughter room

to the inedible handling room are designed to prevent objectionable

odors from inedible and condemned products from entering edible

products rooms.

* If rendering facilities are not available at the establishment

watertight storage facilities should be provided to hold these products

before their removal to rendering plant. These storage facilities

should be separate and apart from edible products rooms, and

constructed to prevent unsanitary conditions including attraction or

harborage for vermin.

* Areas for inedible trucks should be paved and enclosed for ease

of cleaning and to control odors and vermin.

* Where necessary, the boiler room should be a separate room to

prevent dirt and objectionable odors entering from it into rooms where

meat products are processed or handled.

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

Establishments that process byproducts into animal, pet, or fish

food should provide rooms for decharacterizing, chilling, packaging, or

[[Page 45029]]

otherwise preparing the byproducts. Consider the following guidelines

when designing and constructing these rooms:

* Byproducts to be used as animal, pet, or fish food should be

stored separately to prevent cross contamination and commingling with

edible products.

7. Coolers and Freezers

Coolers and freezers need to have enough space to refrigerate and

store product. Product should be stored in a manner that will preclude

conditions which may lead to contamination of product. The following

guidelines will assist you in preventing conditions which could lead to

contamination of your product:

* Coolers and freezers, including doors, should be constructed of

materials that can be readily and thoroughly cleaned, and durable,

rigid, impervious to moisture, non-toxic, and non-corrosive. Freezer

doors should be constructed and installed to prevent accumulation of

frost.

* Coolers and freezers should be equipped with floor racks, pallets

or other means to ensure protection of product from contamination from

the floor.

8. Dry Storage

Packaging materials and ingredients should be stored to preclude

conditions which may lead to contamination of product. The following

are guidelines which may assist you in the planning of your dry storage

area:

* Dry storage materials should be stored in a room dedicated to dry

storage only.

* The dry storage area should be constructed so that racks can be

spaced away from the walls and passageways maintained between rows.

This facilitates cleaning of the area. In addition, the construction

should allow for all meat or poultry ingredients and/or packaging

materials to be stored in closed containers on racks or pallets.

9. Incubation Room for Canned Products

A room or incubator for incubating samples of fully-processed

canned meat or poultry must be provided in all establishments

conducting regular canning operations. Consider the following

guidelines when building this room:

* An accurate time/temperature recorder must be provided. To

prevent temperature variations, a means for air circulation should be

provided.

* Shelves should be provided to hold canned product. The shelves

should be made of expanded metal or heavy gauge wire mesh and be

removable for cleaning.

* The floor in the room should be pitched to a floor drain equipped

with a removable screw-plug.

* The door of the room should be equipped for sealing by the

inspector, if necessary.

10. Vehicular Areas Outside the Building

Special care should be given in the design of vehicular areas

outside your building, not only to provide room for trucks and other

vehicles to operate without damaging your building, but to prevent

unsanitary conditions which might contaminate product in your

establishment. You should consider the following in designing your

vehicular areas:

* Areas outside the building where vehicles are loaded or unloaded

should be paved with concrete or a similar hard surface. Hard surface

areas allow these areas to be kept clean and eliminate the potential

for water puddles or dust.

* Areas outside the building where vehicles are loaded or unloaded

should be drained. Drainage from the loading docks should be confined

to the immediate area of the dock.

* The vehicular areas should be large enough to accommodate the

turning radius of the largest trucks or shipping vehicles used by the

establishment.

* The vehicular areas adjacent to the establishment should have

hose connections for cleaning.

Chapter 3

WELFARE FACILITIES FOR ESTABLISHMENT EMPLOYEES

One source of potential contamination of product is cross

contamination from employee welfare facilities. In designing and

locating employee facilities, great care should be given to preventing

overcrowding and congestion and to providing enough handwash sinks and

toilets for your employees. This chapter provides additional guidelines

that you may wish to consider in making any modifications to or

building any welfare facilities for your employees.

1. Dressing (Locker) Rooms

Dressing rooms must be provided for employees. In addition to

privacy considerations, these dressing rooms should be located where

they will not be a potential source of cross contamination of product.

Consider the following guidelines for these dressing rooms:

* Dressing rooms should be separate from rooms or compartments

where product is prepared, stored, or handled.

* Dressing rooms should be separated from the toilet area.

* Separate dressing rooms should be provided for each sex if both

sexes are employed by the establishment.

* Dressing rooms should have abundant, well-distributed light of

good quality.

* Separate dressing rooms for raw product and other product

department employees will help prevent cross contamination of product.

* Receptacles for soiled clothing should be provided adjacent to

employees' dressing rooms.

2. Lockers

Lockers should be provided for employees clothing and personal

items. To prevent insanitary conditions, consider the following

guidelines when choosing the type of lockers and the arrangement and

locations for them:

* To prevent the potential for cross contamination, the location of

lockers should be separate from rooms or compartments where product is

prepared, stored, or handled.

* Lockers should be large enough to store a change of clothing and

other personal items.

* For ease of cleaning, lockers should be constructed of materials

that are rigid, durable, non-corrosive, easily cleaned and inspected,

impervious to moisture, a light, solid color, with a smooth or easily

cleaned texture, and have sloping tops.

* Lockers should either be installed so that there is enough room

under them that they can be easily cleaned and inspected, or they

should be sealed to the floor.

3. Drinking Fountains

Sanitary drinking water fountains should be provided. Consider the

following guidelines when installing drinking water fountains:

* Drinking water fountains should be provided at convenient

locations throughout the establishment to minimize the distance that

employees need to travel to reach a fountain. This is especially

important in preventing cross-contamination from employees working in

raw or inedible areas and traveling to processing or ready-to-eat areas

to use a fountain. Consider the following locations for placing

drinking fountains:

** welfare areas including cafeterias, dressing (locker) rooms, and

toilet rooms

** inspectors' offices

** edible product areas including kill floor, deboning, and cut-up

areas

** inedible product areas

** immediately outside freezers and coolers

[[Page 45030]]

** storage areas

* Drinking water fountains should be connected to the potable water

supply and either directly connected to the underfloor drainage system

or should discharge through an air gap to a hub drain.

* Drinking water fountains should be other than hand operated, and

if placed as part of handwash sink, should be located high enough to

avoid splash from the sink.

4. Toilet Rooms

Toilet rooms can easily become a source of potential contamination

of product. Care should be taken in the design of these rooms from

their location in the establishment's layout to the number of toilets

provided. Consider the following guidelines:

* Toilet rooms need to be separated from the rooms and compartments

in which products are prepared, stored, or handled.

* Toilet rooms that open directly into rooms where meat products

are exposed should have self-closing doors and should be ventilated to

the outside of the building.

* Toilet rooms should be arranged so they are entered through an

intervening dressing room or vestibule and not directly from a

production or storage room.

5. Eating Rooms and Areas

To prevent employees from contaminating products or contaminating

their food with microorganisms from the raw products or from their

working environment consider the following:

* Separate eating rooms or areas should be provided for employees.

6. Handwash Sinks

One of the most important steps you can take to prevent cross

contamination of product by your employees is to provide conveniently

located handwash sinks. Handwash sinks are needed in toilet rooms,

dressing (locker) rooms, and production rooms. Consider the following

guidelines when making decisions as to where you need a handwash sink:

* Handwash sinks are needed near toilet rooms and dressing (locker)

rooms. They should be other than hand operated. There should be hot and

cold running water, soap, and towels. Single use towels should be used.

* Handwash sinks in welfare rooms and areas should have a

combination mixing faucet delivering both hot and cold water with an

high enough above the rim of the bowl to enable the washing of arms as

well as hands.

7. Ventilation

In designing your welfare rooms, such as toilet and dressing rooms,

care should be taken to make sure that they are ventilated to prevent

odors from entering production areas. Consider the following

guidelines:

* Welfare rooms that are not air conditioned should be mechanically

ventilated through an exhaust fan taking air to the outside. Airflow

from welfare rooms should be released outside the establishment.

* Toilet and dressing rooms that are located where no natural

ventilation is available should be equipped with an exhaust fan

(activated by a common switch with the lighting in the area) and a duct

leading to the outside. Doors to dressing and toilet rooms ventilated

in this manner should have a louvered section about 12 inches by 12

inches minimum in the lower panel to facilitate airflow.

8. Employees Working in Inedible Product Areas

Association of employees working in inedible product areas with

other employees through common welfare rooms increases the risk of

cross-contamination of product. To minimize this risk to product,

consider the following guidelines:

* Separate welfare rooms for employees working in areas such as

hide cellars, condemned or inedible product rooms, or live animal

holding areas, from welfare rooms of other employees working with raw

or heat processed, exposed, edible product.

Chapter 4

CONSTRUCTION

A frequently overlooked area of construction design is the

selection of appropriate construction materials for the establishment.

This chapter provides guidelines for construction and the selection of

construction materials that you may wish to consider when making

modifications to your current establishment or building a new one.

1. Building Construction Materials for Rooms (Finished Surfaces)

Production and storage areas need to be constructed with materials

that are readily and thoroughly cleaned. Product in production and

storage areas is at risk for contamination from indirect contact with

materials used for construction of the building. In order to be readily

and thoroughly cleaned, building construction materials in production

and storage areas must be:

* Rigid and durable.

* Non-toxic and non-corrosive.

* Impervious to moisture.

* A light, solid color such as white.

* Smooth or textured with an easily cleaned, open pattern, for

example, a pattern where the veins and depressed areas are continuous

or have an outlet and are not enclosed.

In addition, consider the following guidelines for selecting

construction materials:

* In non-production and non-storage areas, building construction

materials should be easy to clean thoroughly.

* Special consideration should be given before using wood as a

construction material.

** Wood is absorbent and can absorb not only water but other

substances including chemicals that create a risk for contamination of

meat or poultry products.

** Wood is easily damaged and may create wood particles (splinters)

that contaminate meat or poultry products.

** If wood is used as a construction material in exposed product

areas of the official establishment, it is recommended that the wood be

milled smooth and completely sealed with a coating to prevent the wood

from adulterating meat or poultry product. The coating should be able

to be readily and thoroughly cleaned durable, rigid, impervious to

moisture, non-toxic, and non-corrosive.

** The use of hot linseed oil to treat or coat wood in exposed

product areas is not recommended because it promotes the growth of

molds and fungi.

2. Floors

In addition to any obvious debris on a floor, product can become

contaminated by the flooring or microorganisms living in debris in tiny

crevices in the floor. In order to avoid these sources of

contamination, consider the following guidelines when selecting and

installing flooring in your establishment:

* Floors in areas where product is handled or stored should be

constructed of durable, easily cleanable materials, and be impervious

to moisture. Commonly used materials are concrete, quarry tile, brick,

and synthetic material.

* Floors should be installed and maintained to reduce the

likelihood of cracks, depressions, or other low areas that would

accumulate moisture.

* Floors where operations are conducted should have a slip-

resistant surface. Good results are obtained by using brick or concrete

floors with abrasive particles embedded in the surface. Concrete floors

should have a rough finish.

[[Page 45031]]

* Floors should be sloped to avoid puddles or depressions within

the slope where water will stand.

3. Coving/Curbs

Coving is used at the wall-floor juncture, column (post)--floor

juncture, and equipment support-floor juncture to provide a smooth

transition for ease of cleaning and inspection. Consider the following

guidelines when using coving or curbs:

* Coving in production and storage areas should include the

following criteria:

** All seams should be tight-fitting and sealed to eliminate all

cracks and crevices which may shelter insects, vermin, and

microorganisms.

** The coving should eliminate any sharp angles that allow the

accumulation of materials.

* Curbs should be provided to protect walls and wall finishes.

Curbs should be high enough to protect the walls from pallets, trucks,

or containers used in the establishment. Coving should be provided at

the base of the curb.

4. Stairs

In selecting stairs consider the following:

* Stairs should have solid treads and closed risers and should have

side curbs of similar material.

5. Catwalks and Access Platforms

When installing catwalks and access platforms consider the

following guidelines:

* Catwalks and access platforms in edible product handling

departments should be constructed of materials that meet the same

guidelines as flooring.

* Open grating should not be used for the flooring of catwalks and

access platforms inside the establishment, particularly in production

areas. Dirt and other debris from shoe soles can be scraped off by the

grating and contaminate product, packaging material, and equipment.

* Catwalks and access platforms should not be installed over

production lines and processing equipment.

6. Interior Walls Including Posts and Partitions

To prevent product from becoming contaminated by contact with

interior walls, care needs to be taken in selection of materials for

the finished surface of walls. Consider the following when selecting a

finish:

* Interior walls, in areas where product is stored or handled,

should be finished with materials that will make them susceptible to

being readily and thoroughly cleaned and impervious to moisture.

Examples of such materials are glazed brick, glazed tile, smooth

concrete, and fiberglass reinforced plastic (FRP).

* Walls should have a smooth texture, not one that is rough or

uneven.

* Fasteners for wall covering material should be solid, smooth

headed, and not have recesses which allows the collection of foreign

material.

7. Ceilings

Ceilings, in areas where product is stored or handled, should be

constructed to prevent the collection of dirt or dust that might sift

through from the areas above or fall from overhead collecting surfaces

onto equipment or exposed products. Therefore, it is recommended that

ceilings and overhead structures be maintained free of sealing paint or

plaster, dust, condensate, leaks, and other materials or defects. In

addition, ceilings in areas where product is stored or handled should

be constructed and finished with materials that can be thoroughly

cleaned and are moisture resistant. Examples of such materials are

smooth concrete and fiberglass reinforced plastic.

8. Windows and Skylights

Windows (and skylights) can be a potential source of contamination

of product by dirt, water, debris, or broken glass. Consider the

following when selecting and installing windows:

* All outside windows, except for those in receiving and feed

rooms, should have protection to exclude insects, birds, and other

vermin.

* Window ledges should be sloped about 45 degrees to prevent the

accumulation of dirt, water, or debris.

* To avoid damage to window glass from impact of hand trucks and

similar equipment, the sills should be at least 3 feet above the floor.

* Windows that are installed in walls in exposed product rooms

should have panes of acrylic or polycarbonate plastic or other shatter-

proof material.

9. Doorways and Doors (General)

Doors are barriers that allow the movement of product and people,

but also present a barrier to contamination such as dirt, insects, and

other vermin as well as the microbiological hazards that they carry.

The door type, construction material, and room in which the door is

located are all important considerations when doors are installed in

the establishment. Doors are important in maintaining sanitary

conditions especially in production and storage areas. In production

and storage consider the following guidelines for doors:

The most effective doors have the following characteristics:

* They are impervious to moisture.

* They are tight fitting to minimize air exchange and to prevent

the entry of insects and vermin into the establishments.

* They are self-closing and used throughout the establishment,

especially in areas where toilet rooms open directly into rooms where

meat and poultry are exposed, to prevent contamination of products with

odors and their associated contaminants.

* They are high and wide enough to allow the movement of exposed

product through the doorways without it coming into contact with the

door or jamb.

* They are rigid and durable, and the junctions at jambs, walls,

and floors are sealed to eliminate all cracks and crevices for debris,

insects, and dirt to collect.

* Doors that open directly to the outside of the building from

production rooms should have an intervening closed space, such as a

vestibule or enclosed lock, to prevent the direct access of

contaminants and microbial organisms to areas inside the establishment.

10. Types of Doors

In selecting a type of door for your establishment you need to

consider the location of the door and whether or not product will be

traveling through it. The following guidelines for different types of

doors may be useful to you when selecting a door:

* The horizontal double-swinging, impact door is a bi-parting,

inflexible panel door with plastic windows (vision panels) that swings

only in the horizontal plane. If you select this door, consider the

following:

** This door may be useful in rooms with dimensions that would not

permit the use of a roll-up, vertical sliding or horizontal sliding

door.

** Because this door must be manually opened, the door can be

damaged creating sanitation and maintenance problems.

* The horizontal sliding door (manual and automatic) is a single or

bi-parting, inflexible door that moves only in the horizontal plane. If

you select this door, consider the following:

** This door may be useful in rooms with dimensions that would not

permit the use of a roll-up or vertical sliding door.

** The automatic opening option is recommended not only for

sanitation reasons, but it also prevents damage.

* The vertical sliding door (manual or automatic) is a single,

inflexible panel door that moves only in the

[[Page 45032]]

vertical plane. If you select this door, consider the following:

** This door may be useful in rooms with dimensions that would not

permit the use of a roll-up or horizontal sliding door.

** The automatic opening option is recommended not only for

sanitation reasons, but it also prevents damage.

* The overhead garage-type door (manual or automatic) is a hinged,

multi-paneled door that moves from the vertical to the horizontal

plane. If you select this door, consider the following:

** This door may be an excellent choice for sheds or buildings used

to store equipment, such as a lawn mower, that is used for the outside

maintenance of the establishment's property.

** It is recommended that these types of doors not be used in

exposed product areas or areas subject to wet clean-up because these

doors have spaces between the panels that allow the collection of

product, such as meat and fat, as well as contaminants.

* The roll-up door (manual or automatic) is a single flexible panel

door that moves only in the vertical plane and when open, coils tightly

onto a drum assembly. If you select this door, consider the following:

** This door can be an excellent alternative especially where space

for opening a door is limited.

** Several additional features should be installed on this type of

door to make it an effective barrier against contamination.

* The air curtain or air door is a door that uses a layer of air

generated by mechanical fans to separate two rooms or areas. If you

select this door, consider the following:

** This door needs to be carefully selected, installed, and

maintained to be effective.

** If an air imbalance (pressure imbalance) develops at the door

opening, the separation effect may be diminished or eliminated. Air

imbalance can occur from air flow changes from any other openings in

the rooms especially other doors.

** The movement of the air can stir up contaminants, such as dirt

and dust, if the area around the door is not kept clean.

Chapter 5

LIGHTING, VENTILATION, REFRIGERATION, AND EQUIPMENT

Controlling the manufacturing environment is important in

maintaining a sanitary environment in meat and poultry operations. This

chapter provides guidelines concerning lighting, ventilation,

refrigeration, and equipment for meat and poultry establishments that

you should consider in building or modifying an establishment.

1. Lighting

Well-distributed, good-quality artificial lighting is needed at all

places where natural light is unavailable or insufficient. Lighting is

critical to maintaining a sanitary environment for slaughter and

processing operations. Without adequate lighting, insanitary conditions

are often difficult to see and correct. When selecting and installing

lighting systems, consider the following requirements:

* Light fixtures in rooms where exposed meat or poultry is handled

should ensure maximum safety, to preclude contamination of products

with broken glass and prevent the collection of dirt, product, and

debris on lamp surfaces, including fixture surfaces not easily cleaned

or inspected.

* Lighting must be intense enough to allow both the establishment

and inspection personnel to see insanitary conditions and product

contamination. The intensity of lighting is measured in foot candles.

The following charts provide recommendations for minimum foot candles

for artificial lighting:

Table 1.--Guidelines for Minimum Lighting Intensity in Meat

Establishments

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

30 ft. 50 ft.

Area candles candles

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

General lighting (in areas where animals are

killed, eviscerated, and products are processed

or packaged)..................................... X

Offal cooler...................................... X

Carcass coolers................................... X

Freezers.......................................... X

Dry storage....................................... X

Ante-mortem inspection............................ X

Suspect pen inspection area....................... ......... X

Inspection stations............................... ......... X

Establishment quality control inspection areas.... ......... X

Reconditioning and reinspection areas............. ......... X

All other areas................................... X

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

Table 2.--Guidelines for Minimum Lighting Intensity in Poultry

Establishments

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

30 ft. 50 ft. 200 ft.

Area candles candles candles

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

Ante-mortem inspection................. X

Inspection station (traditional)....... ......... X

Inspection station (NELS/SIS/NTI)...... ......... ......... X

Pre and post chill inspection areas.... ......... ......... X

Reconditioning and reinspection areas.. ......... ......... X

Establishment quality control

inspection areas...................... ......... ......... X

All other areas........................ X

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

2. Ventilation

There should be enough ventilation for all areas of the

establishment including workrooms, processing, packaging, and welfare

rooms to ensure sanitary conditions. A good ventilation system is

important to the production of wholesome meat and poultry products.

Without controlling the quality of the air coming into the

establishment, products may become contaminated with dust, insects,

odors, or condensation. When designing your ventilation systems, you

should consider the following guidelines:

* The ventilation system should be designed so that turbulence is

avoided. The longer the distance the air has to flow, the greater the

resistance the air encounters not only from static air, but from solid

objects such as walls, equipment, people, and product.

* The ventilation system should be designed with the size of the

establishment in mind. The larger the facility, the greater the volume

of air that must be moved.

* The ventilation system should be designed to compensate for

changes in outside temperature and humidity that cause condensation

problems within the establishment.

* Screens and filters should be used where needed to screen out

dust, odors, and insects brought in from the outside to prevent product

contamination.

* Mechanical ventilation should be used to bring in fresh air to

areas where natural ventilation is inadequate.

* Ventilation should prevent vapor formation, such as steam or fog,

that would affect sanitation or interfere with the inspector's ability

to perform inspection.

[[Page 45033]]

* When exhaust fans are installed, provision should be made to

provide enough outside make up air to prevent air from being drawn into

and through docks, coolers, and production areas to the area served by

the exhaust fan.

3. Equipment (General Design and Construction)

Equipment materials should comply with 21 CFR, Parts 170-190 of the

Food and Drug Administration (FDA) regulations for direct food contact.

Equipment and utensils used for handling as preparing edible

product or ingredient in any official establishment should be easily

cleaned and not be a source of contamination. Consider the following

guidelines when selecting equipment.

* All direct product contact surfaces should be smooth; maintained

free of pits, cracks, crevices and scale; corrosion and abrasion

resistant; non-absorbent; shatterproof; nontoxic; and not capable of

migrating into food products.

* Equipment should not be painted on areas in or above the direct

product contact area.

* Construction materials that are sources of contamination include

cadmium, antimony or lead as plating or the plated base material, lead

exceeding 5 percent in an alloy and enamelware and porcelain used for

handling and processing product.

* Equipment should be designed and installed in such a way that

foreign materials, such as lubricants, heat exchanger media,

condensate, cleaning solutions, sanitizers and other nonfood materials,

do not contaminate food products.

* Equipment is self-draining or designed to be evacuated of water.

* All product contact surfaces allow contact with cleaning

solutions and rinse water.

* Clean-in-place (CIP) systems should have sanitation procedures

that are as complete and effective as those for cleaning and sanitizing

disassembled equipment. To remove all organic and inorganic residues,

CIP systems should meet the following criteria:

** Cleaning and sanitizing solutions and rinse water should contact

all interior surfaces of the system.

** The system should be self-draining, with no low or sagging

areas.

** The pipe interiors should be highly polished (120-180 grit)

stainless steel for easy inspection.

** Easily removable elbows with quick-disconnect mechanisms should

be installed at each change of direction. Elbows should be short enough

to permit verification that the interior has been cleaned.

Chapter 6

WATER SUPPLY

The water supply should be ample, clean, and potable with adequate

pressure and facilities for its distribution in the establishment and

its protection against contamination and pollution.

1. Potable Water

An adequate supply of fresh clean water is of primary importance in

plant operations. The first requirement is that the water supply to the

plant be potable or safe for human consumption or food processing. The

plant water supply must meet the potability standards in the National

Primary Drinking Water Regulations issued by the Environmental

Protection Agency (EPA).

2. Backflow

Public health officials have long been concerned about cross-

connections that may permit backflow in potable water supply

distribution systems. Cross-connections may appear in many forms and in

unsuspected places. Reversal of pressure and flow in the water system

may be unpredictable. Plumbing cross-connections between a potable and

nonpotable water supply may constitute a serious public health hazard.

There are numerous cases where cross-connections have been responsible

for contamination of potable water and have resulted in the spread of

disease. These concerns, as they relate to meat and poultry plants,

deserve special attention. The problem is continual as potable water

and piping systems are installed, repaired, replaced, or extended.

Two basic types of hazard may be created in piping systems: the

solid pipe with valved connections and the submerged inlet. The solid

pipe connection is often installed to supply an auxiliary piping system

from the potable source. It is a direct connection of one pipe to

another pipe or receptacle. Solid pipe connections may be made

accidentally to waste disposal lines when it is incorrectly assumed

that the flow will always be in one direction. An example would be

connecting a line carrying used, nonpotable cooking water from a water

jacket or condenser directly to a waste line without an air gap (see

below). ``Backflow'' will occur with a submerged inlet if the pressure

differential is reversed without an air gap. Submerged inlets are

created when the outflow end of a potable water line is covered with

water or other liquid. The other liquid may not be potable. Submerged

inlets could be created by a hose lying in a pool or puddle of water on

the floor.

Once a cross-connection exists, any situation that causes a

pressure differential with the potable line having the lower pressure

can result in contamination of the entire water distribution system and

potable water supply. This is called backflow and can be produced under

a variety of circumstances as illustrated below:

* Backsiphonage is one form of backflow. It is caused by negative

pressure in the delivery pipes of a potable water supply and results in

fluid flow in the reverse direction. It may also be caused by

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\

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