45016 Federal Register / Vol. 62, No. 164 / Monday, August 25, 1997 / Rules and Regulations

DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

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

381

[Docket No. 95–032F]

RIN 0583–AB93

Elimination of Prior Approval

Requirements for Establishment

Drawings and Specifications,

Equipment, and Certain Partial Quality

Control Programs

AGENCY: Food Safety and Inspection

Service, USDA.

ACTION: Final rule.

SUMMARY: The Food Safety and

Inspection Service (FSIS) is amending

the Federal meat and poultry products

inspection regulations by removing the

requirements for prior approval by FSIS

of establishment drawings,

specifications, and equipment used in

official establishments. Requirements

involving the comparison of blueprints

and specifications with actual facilities

and equipment will end, affording

industry the flexibility to design

facilities and equipment in the manner

they deem best to maintain a sanitary

environment for food production. FSIS

will continue to verify through

inspection that sanitation requirements

are being met. FSIS is also ending its

prior approval of most establishmentoperated 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,
Federal Register / Vol. 62, No. 164 / Monday, August 25, 1997 / Rules and Regulations 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,
45018 Federal Register / Vol. 62, No. 164 / Monday, August 25, 1997 / Rules and Regulations

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

§§ 318.4(d)(2)(ii) and 381.145(d)(2)(ii)

are not being adopted. Also,

§§ 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 §§ 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.
45020 Federal Register / Vol. 62, No. 164 / Monday, August 25, 1997 / Rules and Regulations

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 FDArecognized good manufacturing

practices. Another alternative which

would have provided prior approval
Federal Register / Vol. 62, No. 164 / Monday, August 25, 1997 / Rules and Regulations 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 commandand-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
45022 Federal Register / Vol. 62, No. 164 / Monday, August 25, 1997 / Rules and Regulations

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 designrelated 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

Action

Firms with more

than 500

employees

Firms with fewer

than 500

employees

All firms

Information collection burden reduction—all 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
Federal Register / Vol. 62, No. 164 / Monday, August 25, 1997 / Rules and Regulations 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 nonquantifiable, 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’’:
45024 Federal Register / Vol. 62, No. 164 / Monday, August 25, 1997 / Rules and Regulations

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, Establishmentoperated 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:

§ 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.

§ 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:

§ 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.

§ 317.21 [Amended]

7. Paragraph (b) of § 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:

§ 318.4 Preparation of products to be

officially supervised; responsibilities of

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

§ 318.7 are revised; and

b. In the table in § 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:

§ 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

§ 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

§ 318.4(d) that results in compliance

with this provision.

* * * * *

(c) * * *

(4) * * *

Class of substance Substance Purpose Product Amount

* * * * * * *

Miscellaneous ........ Ascorbic acid,

erythorbic acid,

citric acid, sodium ascorbate

and sodium citrate, singly or in

combination

under quality

control.

To delay discoloration.Fresh beef cuts,

fresh lamb cuts,

and fresh pork

cuts.

Not to exceed, singly or in combination, 500 ppm or 1.8

mg/sq inch of product surface of ascorbic acid (in accordance with 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).

* * * * * * *

* * * * *

§ 318.19 [Amended]

12. Paragraph (e) of § 318.19 is

amended in the first sentence by

removing the words ‘‘total’’ and ‘‘partial

quality control’’.

§ 318.308 [Amended]

13. Paragraph (b) of § 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 § 318.309 is

amended by removing the words ‘‘an

approved’’ and ‘‘program’’ and

paragraphs (b) and (c) of § 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:
45026 Federal Register / Vol. 62, No. 164 / Monday, August 25, 1997 / Rules and Regulations

§ 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.

* * * * *

§ 319.104 [Amended]

17. The last sentence in footnote 3 to

the chart in § 319.104 is amended by

removing the words ‘‘approved by the

Administrator under § 318.4 of this

subchapter.’’

§ 319.105 [Amended]

18. The last sentence in footnote 2 to

the chart in § 319.105(a) is amended by

removing the words ‘‘approved by the

Administrator under § 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 § 327.6 is revised

to read as follows:

§ 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 § 331.3 is revised

to read as follows:

§ 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 § 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:

§ 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 § 381.149

of this part.

25. Section 381.20 is revised as

follows:

§ 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

§ 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:

§ 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.

* * * * *

§ 381.121d [Amended]

27. Paragraph (b) of § 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 § 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:

§ 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
Federal Register / Vol. 62, No. 164 / Monday, August 25, 1997 / Rules and Regulations 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 § 381.222 is

revised to read as follows:

§ 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 § 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.

§ 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’’.

§ 381.309 [Amended]

31. Paragraph (a) of § 381.309 is

amended by removing the words ‘‘an

approved’’ and ‘‘program’’ and

paragraphs (b) and (c) of § 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.
45028 Federal Register / Vol. 62, No. 164 / Monday, August 25, 1997 / Rules and Regulations

2. Separation of Official and NonOfficial 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. Nonpedestrian 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
Federal Register / Vol. 62, No. 164 / Monday, August 25, 1997 / Rules and Regulations 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
45030 Federal Register / Vol. 62, No. 164 / Monday, August 25, 1997 / Rules and Regulations

** 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 crosscontamination 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.
Federal Register / Vol. 62, No. 164 / Monday, August 25, 1997 / Rules and Regulations 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 biparting, 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
45032 Federal Register / Vol. 62, No. 164 / Monday, August 25, 1997 / Rules and Regulations

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

Area 30 ft.

candles

50 ft.

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

Area 30 ft.

candles

50 ft.

candles

200 ft.

candles

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

TABLE 2.—GUIDELINES FOR MINIMUM

LIGHTING INTENSITY IN POULTRY ESTABLISHMENTS—Continued

Area 30 ft.

candles

50 ft.

candles

200 ft.

candles

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.
Federal Register / Vol. 62, No. 164 / Monday, August 25, 1997 / Rules and Regulations 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; nonabsorbent; 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 selfdraining, 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. Crossconnections may appear in many forms

and in unsuspected places. Reversal of

pressure and flow in the water system

may be unpredictable. Plumbing crossconnections between a potable and

nonpotable water supply may constitute

a serious public health hazard. There

are numerous cases where crossconnections 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.
45034 Federal Register / Vol. 62, No. 164 / Monday, August 25, 1997 / Rules and Regulations

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 crossconnections:

* 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 crossconnections 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
Federal Register / Vol. 62, No. 164 / Monday, August 25, 1997 / Rules and Regulations 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, pretreatment, 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 fullheight 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 antemortem 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,
45036 Federal Register / Vol. 62, No. 164 / Monday, August 25, 1997 / Rules and Regulations

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 fullheight 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.
Federal Register / Vol. 62, No. 164 / Monday, August 25, 1997 / Rules and Regulations 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 DISTANCES IN CATTLE SLAUGHTERING

ESTABLISHMENTS

Item Vertical

distance

Horizontal

distance

Bleeding rail (distance from rail to

point of application of shackle to

shackle foot—4

feet (1.2 m)).

16 feet

(4.9 m)

Dressing rails (trolley length—1

foot 3 inches.

(.4 m)) ................

12 feet 3

inches

(3.7 m)

Beef cooler rails

(trolley length—1

foot 3 inches.

(.4 m)) ................

11 feet

(3.4 m)

Moving equipment—heights of

conveyor rails,

platforms, top of

viscera inspection table.

Dry landing area in

front of stunning

pen.

7 by 8 feet

(2.1 by

2.5 m)

Curb of bleeding

area to pitch

plates (no header rails).

5 feet

(1.5 m)

Between header

rail and carcass

washing rail, if

parallel.

6 feet

(1.8 m)

Between header or

washing rails and

wall of slaughtering room.

3 feet

(.9 m)

Between center

lines of dressing

beds.

8 feet

(2.5 m)

Between moving

top table and

dressing rail at

inspector’s platform.

5 feet 6

inches

(1.7 m)

Area for sterilizing

viscera inspection truck.

7 by 8 feet

(2.1 by

2.5 m)

Note.—When rails are involved in horizontal

distance measurements, the distance is measured from the center of the rail. When rails are

involved in vertical distance measurements,

the distance is measured from the top of the

rail to the highest part of the floor.

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 pushin 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.
45038 Federal Register / Vol. 62, No. 164 / Monday, August 25, 1997 / Rules and Regulations

* 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

Item Vertical distance Horizontal distance

Bleeding rail for calves (distance from top of rail to point

of application of shackle to shackled foot—2 feet 6

inches (.8 m)).

11 feet (3.3 m) ..........................................

Bleeding rails if only sheep or goats are slaughtered ..... 9 feet–11 feet (2.7 m–3.4 m) ....................

Dressing rail (trolley length—1 foot (.3 m)) ..................... 8 feet 6 inches (2.6 m) ..............................

Cooler rails, calf carcasses (trolley length—1 foot (.3

m)).

8 feet 6 inches (2.6 m) ..............................

Cooler rails, sheep or goat carcasses (trolley length—1

foot (.3 m)).

7 feet 6 inches–8 feet 6 inches (2.3 m–

2.6 m).

Moving equipment ............................................................ ....................................................................

Vertical of rail to edge of viscera inspection stand .......... .................................................................... 2 feet (.6 m)

Length of rail from point of evisceration to point where

carcass inspection is completed.

.................................................................... 6 feet (1.8 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.

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 °F (21 °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 scalding vat.

9 feet (2.7

m).

Dressing rails 1 ....................... 11 feet (3.3

m).

Gambrels (suspending carcasses to floor (1 foot (.3

m)).

10 feet (3 m).

TABLE 5.—GUIDELINES FOR DISTANCES IN HOG SLAUGHTERING ESTABLISHMENTS—Continued

Item Vertical distance

Distances from rail to bottom

of inspection pans and various foot platforms.

Rails in coolers for hog carcasses with heads removed

(1 foot (.3 m)).

9 feet (2.7

m).

Rails to coolers for carcasses

with heads attached (1 foot

(3 m)).

10 feet (3 m).

Vertical of dressing rail to various foot platforms and

widths of platforms.

1 Heads dropped but still attached.

Note.—When rails are involved in vertical

distance measurements, the distance is measured from the top of the rail to the highest part

of the floor.

24. Scalding

To avoid contamination of the

carcass, a scalding tank is used to

remove hair and other contaminants.
Federal Register / Vol. 62, No. 164 / Monday, August 25, 1997 / Rules and Regulations 45039

Consider the following when installing

a scalding tank:

* A mechanical exhaust fan above the

scalding tank will disperse steam.

25. Shaving, Singeing, and Carcass

Washing

* A shaving rail (throw-out rail)

should be provided prior to the head

dropping operation, so that unclean

hogs can be removed from the dressing

line for cleaning.

* If a singer is used to remove hair,

it should have an automatic cut off and

starter switch to prevent the carcass

from burning when the chain stops.

* If a polisher is used, water sprays

to clean the carcass of hair should be

provided.

* To remove hair from the hide

which was missed by the scalder and

dehairing process, a carcass washer

should be located at a point after

completion of shaving operations and

before the head dropper’s station.

26. Inspection Facilities

Special facilities are needed for USDA

post-mortem inspection for swine.

Consider the following guidelines when

designing these stations:

* An inspection station consisting of

5 feet (1.5 m) of unobstructed line space

for each head or carcass inspector must

be provided.

* When viscera tables are used, there

must be 8 feet (2.5 m) for each viscera

inspector on the inspector’s side of the

table needs to be provided.

* A minimum of 50 foot candles of

shadow-free lighting at the inspection

surfaces of the head, viscera, and

carcass must be provided.

* A handwash sink (other than one

which is hand operated), furnished with

soap, towels, and hot and cold water,

must be provided adjacent to the

inspector’s work area.

* For each head inspector on swine

slaughter lines, a sterilizer must be

located adjacent to the inspector’s work

area.

* For mechanized operations, a line

control switch must be provided

adjacent to each inspection station.

* For swine slaughter lines requiring

three or more inspectors, and for those

one-and two-inspector configurations

where the establishment installs a

mirror, special facilities are needed. At

the carcass inspection station one glass

or plastic, distortion-free mirror, at least

five by 5 feet (1.5 by 1.5 m), must be

mounted at the carcass inspection

station. The mirror should be mounted

far enough away from the vertical axis

of the moving line to allow the carcass

to be turned, but not over 3 feet (90 cm)

away, to allow any inspector standing at

the carcass inspection station to readily

view the back of the carcass.

* Facilities to position tally sheets or

other recording devices, such as digital

counters and facilities to contain USDA

condemned brands must be provided.

Equines—Additional Facilities

In addition to the general guidelines

in sections 1 through 8, and the

guidelines for cattle in sections 9–19, if

you plan to slaughter equines, such as

horses, mules, donkeys, and ponies, the

following are additional guidelines

when building or modifying equine

slaughter facilities.

27. Equine Slaughter Facilities

* The facilities for equine slaughter

establishments are essentially the same

as those for slaughtering cattle.

Exceptions include the following rail

heights and clearances.

TABLE 6.—GUIDELINES FOR DISTANCES IN EQUINE SLAUGHTERING

ESTABLISHMENTS

Items Vertical

distance

Horizontal

distance

Bleeding rail .......... 18 feet

(5.5 m)

Dressing rails (trolley length—1

foot 3 inches (.4

m)).

12 feet 6

inches

(3.8 m)

Cooler rails (trolley

length—1 foot 3

inches (.4 m)).

12 feet 6

inches

(3.8 m)

Cooler rails for carcasses in quarters.8 feet 6

inches

(2.6 m)

Line of drop-offs to

line of half hoists.

17 feet

(5.2 m)

Clearance between

walls, posts, etc.

and adjoining

rails in slaughter

rooms and coolers.

3 feet

(.9 m)

Curb of bleeding

area to pritch

plates.

6 feet (1.8

m)

Dry landing area

(minimum).

7 by 8 feet

(2.1 by

2.5 m)

Note.—When rails are involved in horizontal

distance measurements, the distance is measured from the center of the rail. When rails are

involved in vertical distance measurements,

the distance is measured from the top of the

rail to the highest part of the floor.

Chapter 10

POULTRY SLAUGHTER

ESTABLISHMENTS

Although the flesh of healthy living

poultry is practically sterile, when the

bird is killed many factors can

contribute to contamination of the

carcass including improperly designed

and constructed slaughter facilities.

This chapter provides guidelines for

facilities for poultry slaughter

establishments for you to consider in

building or modifying your slaughter

facilities. If you slaughter small animals

such as rabbits or migratory fowl under

voluntary inspection, use this chapter

for guidance. See Chapters 1 through 8

for general information which applies to

all official meat and poultry

establishments.

1. Holding Sheds or Coops

When building holding sheds or

coops for poultry, consider the

following guidelines:

* A minimum of 30 foot candles of

lighting must be provided to facilitate

ante-mortem inspection.

* The holding sheds should be

weather tight.

2. Docks for Receiving and Hanging Live

Poultry

Consider the following guidelines to

prevent dust, feathers, and other

obnoxious substances from entering

areas where edible products are being

prepared, handled, or stored:

* The live hanging dock needs to be

physically separated from these areas.

The separation should be accomplished

by full height impervious walls with

self-closing impervious doors, and

openings limited to that necessary for

poultry conveyor systems.

3. Slaughter Area

Consider the following guidelines for

the slaughter area to minimize risk of

contamination to products:

* The slaughter area (including

stunning, bleeding, picking, scalding,

and eviscerating operations) should be

separated from those areas of the

establishment where edible products are

prepared or stored to minimize the risk

of contamination.

* The blood in the slaughtering area,

especially the stunning and bleeding

area, should be contained in as small an

area as possible.

4. USDA Post-Mortem Inspection

Station

There are four systems of post-mortem

inspection: Traditional Inspection, the

Streamlined Inspection System, the

New Line Speed Inspection System, and

the New Turkey Inspection System.

Each of the systems has mandatory

requirements to minimize the risk of

contamination to products and to

promote efficient inspection. However,

with the exception of the lighting

requirements, there are no facilities

guidelines for these post-mortem

systems.
45040 Federal Register / Vol. 62, No. 164 / Monday, August 25, 1997 / Rules and Regulations

5. Facility Guidelines for Poultry

Inspection Stations

Note: There are no facility guidelines

for Traditional Inspection System

facilities except for lighting.

TABLE 7.—FACILITY GUIDELINES FOR POULTRY INSPECTION STATIONS

Facility SIS NELS NTI

The conveyor line should be level for the entire length of the inspection station ................................... X X X

The vertical distance from the bottom of the shackles to the top of the adjustable inspection platform,

when it is set in its lowest position, should be a minimum of 60 inches (150 cm) ............................. X X X

There should be a minimum of 8 feet (2.5 m) of space along the conveyor line for one inspection

station and 16 feet (4.9 m) for two inspection stations ........................................................................ X X

There should be a minimum of 42 feet (12.8 m) of space along the conveyor line for three inspection

stations .................................................................................................................................................. X

There should be a minimum of 6 feet (1.8 m) of space along the conveyor line for the establishment

employee presenting the birds ............................................................................................................. X

There should be a minimum of 4 feet (1.2 m) of space for inspector and a minimum of 4 feet (1.2 m)

of space for the establishment helper along the conveyor line ........................................................... X X X

There should be selectors or ‘‘kick-outs’’ with birds on shackles with 12 inch (30 cm) centers (two inspection stations on line) ...................................................................................................................... X

There should to be selectors or ‘‘kick-outs’’ with birds on shackles with 18 inch (45 cm) centers

(three inspection stations on line) ........................................................................................................ X

A distortion-free mirror should be located at each inspection station which is: at least 3 feet (.9 m)

wide and 2 feet (.6 m) high; adjustable between 5 inches (12.5 cm) and 15 inches (38 cm) behind

the shackles; positioned in relation to the inspection platform so that the inspector is positioned opposite it 8 to 12 inches (20.3 cm to 30.5 cm) from the downstream edge; installed so that guide

bars do not extend in front of the inspection mirror; and illuminated by a light which is positioned

above and slightly in front of the mirror to facilitate the illumination of the bird and mirror surface ... X

There should be a slip-resistant inspection platform with a 42 inch (105 cm) high rail on the back

side and with 1⁄2 inch (4 cm) foot bumpers on both sides and front ................................................... X X X

There should be an inspection platform with a minimum length of 4 feet (1.2 m) and minimum width

of 2 feet (.6 m) ...................................................................................................................................... X X X

There should be an adjustable inspection platform that easily and rapidly adjusts a minimum of 14

inches (35 cm) vertically while standing ............................................................................................... X X X

A trough or other facilities extending beneath the conveyor where processing operations are conducted from carcass opening to trimming should be provided which is wide enough to prevent trimmings, drippings, and other debris from accumulation on the floor or platform; and has enough

clearance between suspended carcasses and the trough to prevent contamination of carcasses by

splash .................................................................................................................................................... X X X

A conveyor line stop/start switch should be provided at each inspection station within easy reach of

the inspector ......................................................................................................................................... X X X

A minimum of 200-foot candles of shadow-free lighting with minimum CRI value of 85, which can be

met by deluxe cool fluorescent lighting, must be provided .................................................................. X X X

Online hand rinsing facilities with continuous flow water withineasy reach should be provided for

each inspector and establishment helper ............................................................................................. X X X

Online hand rinsing facilities with continuous flow water within easy reach must be provided for each

establishment presenter ....................................................................................................................... X

Receptacles for condemned carcasses and parts should be provided at each inspection station ........ X X X

Hang-back racks should be provided and located within easy reach for establishment helpers ........... X X X

6. Facility Guidelines for Poultry

Reinspection Stations

Note: There are no guidelines for

Traditional Inspection System facilities

except for lighting.

TABLE 8.—FACILITY GUIDELINES FOR POULTRY REINSPECTION STATIONS

Facility

Prechill and

postchill reinspection

stations

Reinspection stations

SIS

NELS NTI

There should be a minimum of 6 feet (1.8 m) of space along the conveyor line for the establishment

presenter ............................................................................................................................................... X

There should be a minimum of 3 feet (.9 m) of space along each conveyor line and for SIS after

each chiller ............................................................................................................................................ X X
Federal Register / Vol. 62, No. 164 / Monday, August 25, 1997 / Rules and Regulations 45041

TABLE 8.—FACILITY GUIDELINES FOR POULTRY REINSPECTION STATIONS—Continued

Facility

Prechill and

postchill reinspection

stations

Reinspection stations

SIS

NELS NTI

A table for reinspecting sample birds should be provided which is at least 2 feet (.6 m) wide, 2 feet

(.6 m) deep, and 3 feet (.9 m) high; readily cleanable; and drainable ................................................ X

A table for reinspecting sample birds should be provided which is at least 3 feet (.9 m) wide and 2

feet (.6 m) deep; readily cleanable; and drainable .............................................................................. X X

A space which is level and protected from all traffic and overhead obstructions should be provided ... X X X

The vertical distance from the bottom of the shackles to floor needs to be a minimum of 48 inches

(120 cm) should be provided ................................................................................................................ X X X

A minimum of 200-foot candles of shadow-free lighting with a minimum CRI of 85 at the table surface, which can be met by deluxe cool white fluorescent lighting, must be provided ......................... X X X

A separate clipboard holder for holding the recording sheets should be provided ................................. X X X

Handwash sinks within easy access of all persons working at the station should be provided ............. X X X

Hang-back racks should be provided which are within easy reach of all persons working at the station, and designed to hold 10 carcasses ............................................................................................. X X X

7. Evisceration and Reprocessing Areas

The evisceration area should be

arranged to facilitate efficient sanitary

operations and inspection. Consider the

following guidelines when designing

these areas:

* Production lines should have drip pans

installed beneath them, when these lines are

located above areas such as walkways,

truckways, work stations, and equipment, to

prevent water, poultry products, or any other

material from falling on the production areas

below.

* An area should be provided for a

reprocessing station for the reconditioning of

retained products including removal of

contamination.

8. Inedible Offal

In poultry establishments, the facilities for

handling inedible offal should be designed to

accommodate the size of the poultry being

handled and to prevent the contamination of

edible products. Consider the following

guidelines when designing these areas:

* The facilities, whether troughs or

otherwise, should be large enough to allow

clean and orderly removal of inedible offal

during processing, without a pile up and

without cross contamination of edible

products.

* The water rail for semi-dry poultry offal

systems for young chickens should range

from 34 to 36 inches (86 to 90 cm) in height

above the standing surface and be positioned

7 to 10 inches (18 to 26 cm) horizontally from

the vertical line of the shackle.

* The water rail for semi-dry poultry offal

systems for turkeys should range from 34 to

36 inches (86 to 90 cm) in height above the

standing surface and be positioned 13 to 15

inches (33 to 38 cm) horizontally from the

vertical line of the shackle.

* The floor gutter should be distinct, with

vertical sides inside the post supporting the

water rail (a minimum of 6 inches or 15 cm

is suggested to prevent workers feet from

being in the gutter). Gutters should also be

wide enough to catch all material dropping

from the carcass.

* Splash protectors should be installed at

all points along the evisceration line where

splashing of employees might occur.

* Pipes for conveying offal should be

constructed to permit daily cleaning and

positioned so that sanitation will not be a

problem, i.e., no pipes lying on the floor or

bottom of a gutter.

* Side walls of hoppers should be pitched

to assure that material deposited in the

hopper will slide to the point where the offal

is being mechanically conveyed.

Chapter 11

PLANT WASTE DISPOSAL

Control and disposal of plant wastes

are major concerns. Optimum use and

reduction of waste are essential goals of

economic production in all plants. From

a plant sanitation standpoint, there are

two vital concerns with waste disposal:

(1) Plant waste contains most of the

contaminants and disease-producing

and product-spoiling microorganisms

from the plant production processes; (2)

plant wastes attract pests such as insects

and rodents.

1. Organic Waste Disposal

When disposing of organic wastes such as

feathers, viscera, blood, and manure, the

following guidelines should be considered:

* Waste materials should not be allowed

to accumulate on or near the premises.

* Waste should be disposed of without

creating insanitary or objectionable

conditions.

* Waste should be removed daily.

* Holding bins should be cleaned before

reuse and protected from insect and rodent

harborage and infestations.

2. Rubbish Removal

Rubbish, such as paper towels, cartons,

office waste, and labeling materials, can

become a sanitation problem. The following

guidelines should be followed when

removing rubbish:

* Suitable containers should be

conveniently located throughout the plant

and emptied frequently.

* The accumulation of rubbish before its

removal should not cause a nuisance.

* Plant refuse should be removed daily, or

more often if necessary, to prevent a

nuisance.

Appendix B—Guidelines for

Developing Partial Quality Control

Programs (PQC’s)

Guidelines for Developing Partial

Quality Control Programs Overview

Quality control programs are essential

to the proper functioning of any meat or

poultry processing establishment.

Processors have found quality control is

good business because it can reduce

costs, control product uniformity, and

ensure that proper standards are being

maintained throughout the production

cycle. By increasing controls over raw

ingredients, processes, and other

variables, effective quality control

systems can ensure compliance with

company specifications and with the

guidelines and requirements of the

Department of Agriculture. Although inplant inspectors have a role in the

oversight of these programs, quality

control is a management function and

plant management should develop and

implement effective quality control

plans specific to their process and

products.

There are many approaches plants can

take to ensure quality control. Some

plants do not take any special measures

during production, and changes are

made only on finished product. Some

plants incorporate preventive measures,

such as product testing, during

processing, and others undertake a

series of specific actions to prevent

mistakes and to ensure that products

meet consumer expectations. Whether
45042 Federal Register / Vol. 62, No. 164 / Monday, August 25, 1997 / Rules and Regulations

limited or comprehensive, a quality

control system should be in the written

record of the plant. As experience is

gained, the record keeping system may

be improved by focusing on ‘‘hot spots’’

which are responsible for the major

problems, revising specifications, or

upgrading them to include sensitive

testing devices, for example.

Proper documentation of plant

activities will become increasingly

important in a HACCP inspection

environment. Proper documentation of

any in-plant process can save time and

money and result in fewer mistakes by

the establishment. The degree and

complexity of the records depend on the

scope of the processing operation;

completeness of the records is also a

reflection of management commitment

to quality control.

Plant or corporate management

support is the key to a successful quality

control program. Plant personnel will

sense a lack of commitment to quality

if management support is not apparent.

Good quality control managers do not

necessarily have to use complex,

expensive methods to ensure control.

Experience has shown that successful

establishments function smoothly by

paying close attention to the basics,

documenting the process when it is

running smoothly and when problems

occur, and making necessary corrections

as quickly as possible.

Chapter 1. Introduction

Title 9 of the Code of Federal

Regulations at Parts 318.4(d) and

381.145(d) require Federal meat and

poultry processing plants to establish

and maintain written records for each

critical check or critical control point

and make the records available to FSIS

inspection personnel upon request.

* Although the regulatory

requirement for FSIS to review and

approve PQC programs has been

rescinded, the new regulatory

requirements in 318.4(d) and 381.145(d)

provide information to plants about the

necessary steps they must take to meet

the new record keeping requirements in

a Pathogen Reduction and HACCP

inspection environment.

* FSIS will continue to provide

guidance to establishments to ensure

that their Partial Quality Control (PQC)

programs for specific products and

processes are adequate to ensure

product compliance with regulatory

requirements. The information in this

document is intended to be used as

guidance material and is based on FSIS’

experience and historical perspective

reviewing and approving PQC programs.

A few model PQC programs,

representative of many products and

processes, are presented below.

Chapter 2. Components of PQC

Programs

PQC programs should address four

areas: (1) raw materials control; (2)

process control; (3) records control; and

(4) corrective/preventive action.

1. Raw Materials Control

Raw materials control involves the

receiving and stocking of only those

materials that conform to established

specifications. To ensure successful

control of raw materials, establishments

should consider the following:

* To begin the development of a raw

materials control procedure, plants

should list each of the materials used to

produce the product.

* Once the list has been created,

establishments should develop a

receiving inspection procedure.

* The procedure may address raw

materials specifications, proper

materials handling, proper storage, and

disposal of nonconforming materials.

* Materials should be routinely

monitored to ensure they are meeting

the established procedures.

2. Process Control

Process control programs ensure

continuous control of particular

processes so that product standards will

be met. Process control programs should

meet the following criteria:

* They should identify the products

or processes to be controlled.

* They should identify the control

features necessary for product

compliance.

* They should establish control

limits.

* They should establish procedures

for meeting the established limits.

* They should provide monitoring

procedures for ensuring that procedures

are followed.

An important aspect of process

control is effective data collection and

analysis. Process control programs

should include sampling plans that

permit reliable collection and analysis

of data. After sampling plans have been

developed, process limits can be

established.

* The limits established should be

appropriate to ensure that quality

standards will be met.

* The limits established should be

appropriate to ensure that meet

regulatory or label limits for the product

or process will be met.

* Variation in materials, methods,

processes, and products requires the

setting of a tolerance for each quality

standard. A tolerance limit is the total

allowable deviation from an established

standard. The limit allows for the

normal variability which is inherent in

any process.

* Tolerance limits may need to be

continuously adjusted to prevent

problems.

* Limits for certain processes have

been established and used historically

by industry; these limits are reflected in

PQC programs previously approved by

FSIS. The tolerances meet the intent of

the requirements in 318.4(d) and

318.145(d)(2)(ii) and may continue to be

used.

* Establishments may elect to use

these previously established tolerances

or develop their own by following the

requirements outlined in the regulation.

3. Records

An important aspect of quality control

is process documentation. Adequate

records are essential to the system’s

capacity to provide the necessary

controls. The records provide a history

of the process and document when the

process is working and when problems

are occurring. The use of standard

sheets, check-off forms, and other

simple records is generally more

successful than a complicated system.

Charts and graphs already in use may be

all that is necessary to document the

system. The degree of record keeping

and the complexity of the records

depend, in large part, on the scope of

the processing operation. In reviewing

records, plant management should:

* Look at those aspects of production

most likely to cause problems. This

procedure also can be useful in

determining what critical checks need

to be incorporated into a quality control

program.

* Correct problems as they occur.

Proper documentation of the process

can save time and money because it

provides an establishment an

opportunity to correct a problem before

the finished product has been

completed.

4. Corrective/Preventive Action

Corrective action plans address the

action to be taken when problems

develop in a production process.

Corrective action plans are essential

components and important indicators of

the strength of quality control programs.

The primary emphasis of the plans

should be on correction/prevention of

problems in the production process. The

type of plan used in a particular quality

control program will be determined by

the establishment and the processes

conducted at the plant. Generally,
Federal Register / Vol. 62, No. 164 / Monday, August 25, 1997 / Rules and Regulations 45043

corrective action plans should include

the following features:

* They should provide for the

identification of problems or deviations

in processes.

* They should provide for the

identification of the causes of problems.

* They should specify the corrective

steps to be initiated and the criteria for

determining how noncompliant

products should be handled.

* The plans should provide that

corrective/preventive measures be

implemented after a determination that

no safety hazards exist.

* The plans should provide for

documentation of the corrective and

preventive measures taken.

Models

The following models are intended to

be used as general guidelines to

developers of quality control programs.

They are not intended to be complete

QC programs or a complete listing of all

rotational QC programs but offer a

framework and one approach to QC

program development. In actual QC

programs, details regarding tests, action

criteria, corrective actions, and

responsible personnel would reflect the

specific process and establishment

circumstances. Any specifications or

limits cited are only examples and do

not establish or imply Agency

standards.

Model 1—Preparation of a PQC Program

for the Addition of 10-Percent Solution

to Poultry

Raw Material Control

* Poultry—Chicken breasts will be

received frozen, examined for condition,

and immediately placed in the receiving

dock freezer. (Specifications to be set by

establishment.)

* Dry ingredients—Upon receipt, the

dry ingredients will be visually

inspected for acceptance and

immediately placed in the dry storage

warehouse. (Specifications to be set by

establishment.)

* Corrective action—If either the

poultry or the dry ingredients is found

to be unacceptable, it will be tagged

immediately and Quality Control will be

notified. QC will evaluate and initiate

appropriate product disposition.

* Documentation—All critical checks

and corrective actions will be recorded

on the receiving log.

Process Control

* Formulation control.

** Formulation control—A pumping

solution will be formulated according to

the label formulation. One ingredient of

the solution will be weighed by a

quality control technician for each

batch. If an ingredient is found to be

m0ore than 0.5 percent above or below

the weight stated on the formula, the

following will result: (1) the problem

will be evaluated and the appropriate

corrective action taken; (2) each

ingredient of every batch will be

checked until five consecutive batches

are found to be in compliance.

** Documentation—All formulation

check results and corrective actions, if

needed, will be recorded on the

formulation log.

** Scale accuracy control.

*** Scale checks—All scales

associated with the pumping operation

will be verified for accuracy before

operations begin. Scale accuracy will be

checked against a known weight. If a

scale is found to be inaccurate, it will

not be used until it has been calibrated.

*** Documentation—All scale check

results and corrective actions, if

required, will be recorded on the scale

maintenance record.

Lotting

* A lot will be defined as one shift’s

production; a sublot as approximately

500 pounds of product.

Added Solutions

* Green weight determination—Each

sublot will be identified with a unique

code representing date and time of day

the sublot is being produced.

** The sublot will be weighed before

pumping.

** The identifying code and weight

will be written on a tag, which will be

attached to the combo bin containing

the sublot.

* Pumping—Every 30 minutes, 10

turkey breasts will be selected from a

sublot before it is pumped. The 10

turkey breasts will be weighed, then

passed through the pumping machine.

The turkey breasts will be allowed to

drain for 5 minutes, then weighed again.

** Tolerances—Each pump check

will not be more than 0.5 percent over

the target pump of 10 percent. If a pump

check is found to exceed the tolerance,

all product back the last pump check

will be retained and allowed to drain

until it reaches the target pump. In

addition, the pumping operations will

be stopped, evaluated by a QC

technician, and not allowed to start

until the problem has been corrected.

** Documentation—All pump checks

and corrective actions, if needed, will be

documented in the pumping log book.

* Finished weight determination—

After a sublot has been pumped, a final

weight will be obtained and recorded on

the pumping tag.

** Tolerances—No sublot will be

more than 1.2 percent above the target

pump of 10 percent. The average of all

sublots will meet the target pump. If any

sublot or the average of the sublots

exceeds tolerances, all product will be

retained and allowed to drain until the

target pump has been reached.

** Documentation—All green

weights, finished product weights, and

corrective actions, if needed, will be

recorded in the finished product log

book.

Note: Model also can be used in

developing the following PQC programs:

Percent Labeling Control

Water-misted/Ice-glazed Meat and

Poultry Products

Addition of Solution to Raw/Cooked

Meat and Poultry Products (Injection,

Massaging, Tumbling, Basting,

Marination, and Tenderization)

Fat and/or added water for Raw Product

Model 2.. Preparation of a PQC Program

for Fat-Content-per-Serving Labeling for

Meat and Non-Meat Products

Scales/Meters

* Establish verification procedures to

ensure that all scales/meters used in the

formulation and analytical testing of the

product are accurate. The procedure

should include checks against a

standard weight or measurement.

Lotting

* Define lot and sublot.

* Establish a standardized procedure

for identifying the lot throughout the

process.

Formulation

* Establish a procedure to verify the

formulation of each lot/sublot in

compliance with the approved label

formulation.

* Establish tolerances for nonrestricted ingredients.

* No ingredient in the formulation

should be substituted for another.

Fat content of the meat portion (ground

beef, ground pork, or products with a

declared fat limit on the label)

* Establish a statistically sound

sampling procedure for each lot/sublot

of the meat portion.

* Identify the analytical method

used, such as an AOAC method. Weight

Control (serving and component).

* Establish a statistically sound

sampling procedure to ensure that each

portion and component of the product

within a lot/sublot is checked against

the label transmitted.

* Raw weights—The weight is

checked on all portions and components

on finished raw and cooked products.

* Cooked weights—Cooked weights

are checked and compared with the

portion size stated on the transmittal
45044 Federal Register / Vol. 62, No. 164 / Monday, August 25, 1997 / Rules and Regulations

and on the Child Nutrition (CN) label.

Weights also are checked for precooked

components of products against

information on the label transmittal.

* The sampling plans and tolerances

should be based on generally recognized

statistical process control methods and

should ensure that the process is in

control and that applicable product or

label limits are being met.

* Each CN product should have its

own lot average.

Batter and Breading (if applicable)

* Establish a procedure to verify that

the batter/breading application does not

exceed regulatory limits, label

declarations, or product standards. The

monitoring procedure should identify

the following:

** pre-batter/breading application

weight

** sample size

** sample frequency

** post-batter/breading application

weight

* Post-batter/breading weight should

be determined at the end of the

application procedure and before

further processing. Note: Model also can

be used in developing the following

PQC programs:

Batter and Breading

FES Labeling Content for Meat and

Non-Meat Products

Precooked Breakfast Sausage Yield

Control

Model 3. Low Temperature Rendering

for the Production of Partially Defatted

Chopped (P.C.) Beef/Pork, Fat-Reduced

Species, and Partially Defatted Beef/

Pork Fatty Tissue

Raw Materials Control

* Define a lot and sublot

* If producing P.C. beef/pork or fatreduced species, establish a statistically

based sampling procedure to ensure the

lot is in compliance with raw material

requirements (12 percent lean).

Heat Processing

* Identify processing temperature

(minimum and maximum).

* Identify the target processing time,

which is the time the product is

subjected to the target.

* Establish procedures for monitoring

processing temperatures and times.

Cooling and Freezing Controls

* Identify the cooling and freezing

temperatures for the finished product.

* Identify the amount of time the

cooling and freezing process will take to

reach established temperatures.

Microbiological

* If the cooling/freezing process

(starting from the time heat is applied

until the product is 40 degrees F for

less) exceeds 30 minutes, a

microbiological sampling procedure

should be developed. The following

sampling procedures and limits have

been used in PQC programs in the past,

and current regulations permit their

continued use.

** Using a statistically based

sampling plan, select two samples per

lot from the raw material and finished

products.

** Test samples for total plate count,

coliforms, E. coli, and C. Perfringens.

** Demonstrate that the process does

not increase the product’s microbial

load by 1 log or more.

** Sampling can be reduced to one

per lot when control has been

demonstrated in three consecutive lots.

Finished Product Controls

* If producing finely textured lean or

finely textured extra lean, product

should be tested for fat, protein, and

protein efficiency ratio (PER) or

essential amino acid (EAA).

* Incorporate the sampling procedure

for fat and protein.

** Individual—Obtain a one-pound

sample from each lot. After 10

consecutive analyses are in compliance

with single sample limits, sampling may

be reduced to one randomly sampled lot

out of every three lots.

** Process Average—A process

(moving) average of 10 lots should be

maintained.

Sampling Procedures for PER/EAA

* Initially, each lot should be held

and tested until compliance has been

established. Once compliance has been

established in three consecutive lots,

sampling may be reduced. Sampling

frequency should begin with at least one

sample per month until compliance has

been established. When three

consecutive samples are in compliance,

the frequency may be reduced to one

sample every three months.

* Analytical Standard Limits

Finely Textured Lean Product

Individual;

Fat—Maximum 30%

Protein—Minimum 13%

Process Average:

Fat—Maximum 30%

Protein—Minimum 14%

PER 2.5 or

EAA 33%

Finely Textured Extra Lean Similar

Products

Individual:

Fat—Maximum 11%

Protein—Minimum 13%

Process Average:

Fat—Maximum 10%

Protein—Minimum 14%

PER 2.5 or

EAA 33%

Corrective and Preventive Actions

* Develop corrective and preventive

actions for each critical check point

established.

Note: Model also can be used in

developing the following PQC programs:

Low Temperature Rendering for Control of

Partially Defatted Chopped Beef/Pork

Fat-Reduced Species and Partially Defatted

Beef/Pork Fatty Tissue

[FR Doc. 97–21882 Filed 8–22–97; 8:45 am]

BILLING CODE 3410–DM–P