19578 Federal Register / Vol. 61, No. 86 / Thursday, May 2, 1996 / Proposed Rules

(3) Outer garments, including aprons,

smocks, and gloves, shall be especially

identified as restricted for use in cooked

product areas only, changed at least

daily, and hung in a designated location

when the employee leaves the area.

(C) Cooked product shall not be stored

in the same room as raw product unless

it is first packaged in a sealed, watertight container or is otherwise protected

by a covering that has been approved,

upon written request, by the Circuit

Supervisor.

Done in Washington, DC: April 29, 1996.

Michael R. Taylor,

Acting Under Secretary for Food Safety.

[FR Doc. 96–10796 Filed 5–01–96; 8:45 am]

BILLING CODE 3410–DM–P

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

and 381

[Docket No. 95–032P]

RIN 0583–AB93

Elimination of Prior Approval

Requirements for Establishment

Drawings and Specifications,

Equipment, and Certain Partial Quality

Control Programs

AGENCY: Food Safety and Inspection

Service, USDA.

ACTION: Proposed rule.

SUMMARY: The Food Safety and

Inspection Service (FSIS) is proposing

to amend the Federal meat and poultry

products inspection regulations by

removing current requirements for prior

approval by FSIS of establishment

drawings, specifications, and equipment

prior to their use in official

establishments. Requirements involving

the comparison of blueprints and

specifications with actual facilities and

equipment would end. These

amendments would provide the

regulated industry with the flexibility to

design facilities and equipment in the

manner they deem best to maintain a

sanitary environment for food

production. FSIS would continue to

verify through inspection that good

sanitation is being achieved. Similarly,

FSIS is proposing to end its prior

approval of most establishmentoperated partial quality control

programs, which are used by

establishments to control certain kinds

of food processing and product

characteristics. This change would make

it possible for establishments to develop

and implement quality control programs

without first having to receive

permission from FSIS to do so. This

action is being taken to streamline and

modernize the meat and poultry food

safety regulations, to separate the roles

of Government and the regulated

industry, to encourage innovations that

will improve food safety, and to remove

unnecessary regulatory burdens on

inspected meat and poultry

establishments. In addition, the

proposal represents an important shift

away from FSIS’s ‘‘command-andcontrol’’ regulatory approach and

toward a less bureaucratic approach

consistent with the Agency’s food safety

mission.

DATES: Comments must be received on

or before: July 1, 1996.

ADDRESSES: Please send an original and

two copies of comments on this

proposed rule to FSIS Docket Clerk,

DOCKET #93–032P, Room 4352 South

Agriculture Building, Washington, DC

20250–3700. Oral comments, as

provided under the Poultry Products

Inspection Act, should be directed to

the person listed under FOR FURTHER

INFORMATION CONTACT. Copies of FSIS

reference materials cited in this

proposal are available for review in the

FSIS docket room.

FOR FURTHER INFORMATION CONTACT: Ms.

Patricia F. Stolfa, Acting Deputy

Administrator, Science and Technology,

FSIS, Room 402 Annex Building,

Washington, DC 20250–3700; (202) 205–

0699.

SUPPLEMENTARY INFORMATION:

Background

The Federal Meat Inspection Act

(FMIA) (21 U.S.C. 601 et seq.), and the

Poultry Products Inspection Act (PPIA)

(21 U.S.C. 451 et seq.) direct the

Secretary of Agriculture to maintain

inspection programs designed to assure

the public that meat and meat food

products (meat products) and poultry

and poultry products (poultry products)

are safe, wholesome, not adulterated,

and properly marked, labeled, and

packaged. FSIS carries out the mandates

of these statutes by administering a

continuous in-establishment inspection

program for meat and poultry products

that are shipped in interstate and

foreign commerce or in ‘‘designated’’

States. A number of the States operate

meat and poultry inspection programs

for product shipped intrastate. Under

the FMIA and PPIA, such programs

must impose requirements ‘‘at least

equal’’ to the Federal requirements.

The FMIA and PPIA require the

Secretary to provide, among other

things, for the inspection of

establishments to assure that the

conditions under which meat and

poultry products are produced are

sanitary. The Acts also require the

Secretary to prescribe rules and

regulations governing the sanitary

conditions of official establishments (21

U.S.C. 608 and 456). Pursuant to these

provisions, the meat and poultry

inspection regulations currently

prescribe ‘‘prior approval’’ or approvalbefore-use by FSIS of facility drawings

and specifications and of equipment

used in official establishments. The

regulations also provide for the prior

approval of certain quality control

programs, known as partial quality

control (PQC) programs, before their use

by official establishments.

Current Prior Approval Procedures

Currently, applicants seeking Federal

inspection must submit to FSIS

blueprints and drawings with

specifications that exactly illustrate the

applicant’s establishment as it exists or

is proposed to exist (9 CFR 304.2(a),

308.2, and 381.19). Before inspection is

granted, FSIS officials in the field and

in Washington, D.C., review the

blueprints and drawings and the facility

they represent to determine whether the

facility meets the requirements of the

meat and poultry inspection regulations,

which are intended to ensure that

products can be produced in a sanitary

environment. Owners or operators of

establishments intending to add

structures or remodel their existing

facility must also submit blueprints and

drawings with specifications to FSIS for

review before beginning any new

construction (9 CFR 404.2, 308.2, and

381.19). During FY 1994, FSIS technical

personnel reviewed about 2,900 sets of

blueprints for new or modified facilities.

Federally inspected establishments or

equipment manufacturers must go

through a similar process of prior

submission for review and approval of

most equipment used in preparing or

handling edible meat and poultry

products or ingredients (9 CFR 308.5

and 381.53). FSIS requires that

establishment owners or operators

wishing to use new equipment submit

any information FSIS needs to review

new equipment, including assemblytype drawings and a list showing the

materials of which parts are made. The

primary objectives of the FSIS review

are to determine whether the equipment

can be readily cleaned and inspected for

its sanitary condition. In some

instances, FSIS also requires that the

equipment be used on a trial basis

before approval is granted (9 CFR

308.5(d) and 381.53(a)(4)). FSIS

technical personnel review more than

2,500 submissions of equipment

specifications each year, and

approximately 650 pieces of new

equipment require a trial installation

before being accepted for use.
Federal Register / Vol. 61, No. 86 / Thursday, May 2, 1996 / Proposed Rules 19579

Also, prior-approval procedures exist

for numerous establishment-operated

partial quality control programs. This

means that companies must come to

FSIS for permission before they can

initiate or modify processes or controls

intended to ensure that products have

desired characteristics and that

processes are stable.

The prior-approval process is a

feature of FSIS’s traditional ‘‘commandand-control’’ regulatory approach.

While prior approval provides

assurance that equipment, facilities, or

processes, as designed, meet certain

requirements that are intended to assure

food safety or quality, they reflect the

emphasis of the current system on

closely observing the means by which

establishments maintain sanitation and

produce safe food. This feature of the

current system is an inappropriate

allocation of responsibility between the

Agency and establishments. It is an

obstacle and too often a deterrent to

innovation by establishments seeking to

improve operations, and contributes to

unproductive use of FSIS resources both

in managing the approval system and

policing establishment compliance with

approved facility and equipment

specifications.

In addition, elimination of priorapproval requirements is consistent

with the principles articulated in FSIS’s

February 3, 1995, Pathogen Reduction/

Hazard Analysis and Critical Control

Points (HACCP) proposal (60 FR 6774).

HACCP and the FSIS food safety

strategy are based on the principle that

sanitary measures and science-based

preventive process controls should be

built into the food production system to

reduce or eliminate food safety hazards.

Establishment management should be

responsible for designing and

implementing such process controls, as

well as for developing and maintaining

standard operating procedures (SOP’s)

for its sanitation programs. However,

the current system imposed by FSIS

inappropriately allocates responsibility

between the Agency and the industry

and impedes the ability of establishment

management to implement innovative

food safety strategies. Establishments

conducting their own hazard analyses

and developing the HACCP plans to

meet FSIS’s food safety objectives will

determine whether facility layouts,

equipment operating characteristics,

and other technical components of the

manufacturing process will result in

products that meet required standards.

FSIS’s reliance on prior approvals

also contrasts with both the practices of

the remainder of the food industry as

regulated by the U.S. Food and Drug

Administration and the practices of a

significant number of countries that

have meat and poultry inspection

systems that provide a level of food

safety assurance equivalent to that of the

United States. With the single exception

of Canada, whose meat and poultry

regulatory system is intertwined with

that of the United States, none of these

other countries relies on prior-approval

systems to ensure that equipment does

not adulterate product.

Anticipated Changes in Inspection

The elimination of the prior approval

systems proposed here would change

the manner in which FSIS conducts

certain aspects of its inspection. Under

the current prior approval system, FSIS

focuses substantial attention on

identifying specific design-related

conditions affecting food safety, which

should be the responsibility of the

establishment. For example, FSIS not

only performs prior approval of facility

blueprints and equipment, but also

inspection tasks to verify that the

facility as constructed conforms to the

blueprint and that equipment meets

approved design specifications. This

reflects the fact that the FSIS regulatory

system has, in effect, taken

responsibility for these matters.

Similarly, many establishments

currently lack a written sanitation plan

and do not systematically ensure daily

maintenance of good sanitation. In order

to compensate for this lack, FSIS

inspectors focus considerable attention

on sanitation conditions and practices

that are more appropriately the

establishment’s responsibility.

Under this proposal, FSIS would no

longer control through prior approval

the design specifications for buildings

and equipment. Instead, FSIS would

focus its regulatory and inspectional

attention on determining whether an

establishment is successfully meeting

sanitation standards. Establishments

would ensure that the design of

buildings and equipment is appropriate

for sanitary food production and for

maintaining good sanitary conditions in

accordance with broad sanitation

principles. In addition, the FSIS

proposal to require establishments to

adopt sanitation SOP’s of their own

design, requires establishments to

identify the elements of good sanitation

required to prevent direct product

contamination, carry out the SOP’s on a

daily basis, and achieve acceptable

sanitation results. Concurrent with this

action, FSIS inspection activities under

SOP’s and HACCP would be

restructured to focus not on the building

or equipment design, or on FSIS

approval status, but on whether good

sanitation is, in fact, being maintained.

In concert with this proposal, FSIS

would review and revise its existing

regulations and guidelines to avoid real

or de facto prescriptions that are

inconsistent with the approach outlined

here. This review is underway and

public comments on this process were

invited in an advance notice of

proposed rulemaking, the ‘‘FSIS Agenda

for Change,’’ published in the December

29, 1995, issue of the Federal Register

(60 FR 67469).

Prior-Approval Requirements To Be

Eliminated

A. Establishment Facilities

The demand for Federal inspection of

sanitary conditions of slaughterhouses

was one of the principal concerns

leading to enactment of the 1906 Meat

Inspection Act. Leading experts of the

day in the field of meat inspection

advocated the approval of

slaughterhouse plans by qualified

veterinary inspectors. Facilities for

slaughtering, dressing, and meat

preparation that were properly designed

and built with sound materials that

could be effectively cleaned and not

contaminate product were considered

essential to help prevent the spread of

disease and protect the health and safety

of the animal and human populations.

While the Meat Inspection Act itself did

not mandate prior approval of drawings

as a condition of inspection, early

regulations issued under that law

required the submission to the Agency

of plans for new and remodeled

establishments for review and approval

before inspection could be granted.

The FMIA, the current law governing

meat inspection, continues with slight

modification the provision in the

original meat act assigning to USDA the

responsibility for regulating the sanitary

conditions of inspected establishments

(see 21 U.S.C. 608). The PPIA contains

similar provisions, but neither of the

Acts mandates prior approval of

establishment blueprints.

As a means of assuring sanitary

conditions in inspected establishments,

the meat and poultry inspection

regulations require that applicants for

inspection submit to FSIS the drawings

and specifications of establishments

where inspected operations are to be

conducted for review and approval (9

CFR 304.2, 381.19). The regulations also

require that drawings reflecting any

remodeling be submitted in advance of

construction (§§ 308.2 and 381.18), and

prescribe specifications for facilities of

inspected establishments (at §§ 307,

308, and 381, subparts G and H). This

procedure was required to help avoid

costly changes in construction in the
19580 Federal Register / Vol. 61, No. 86 / Thursday, May 2, 1996 / Proposed Rules

1A copy of Agriculture Handbook 570 is on file

for review in the FSIS Docket Clerk’s office, 4352

South Agriculture Building, Washington DC, 20250.

event that FSIS determined facilities

could create insanitary conditions that

could lead to food adulteration.

To comply with the prior-approval

regulations, the applicant completes a

request form and provides a blueprint

with specifications to the FSIS

inspector-in-charge. The blueprint and

specifications are then reviewed by the

inspection circuit supervisor, the first

level of supervision outside inspected

establishments, and sent directly to

FSIS headquarters in Washington, D.C.

FSIS’s area office—the second level of

supervision in the field organizational

structure, which stands between the

circuit supervisors and the five Regional

Offices—may also review plans referred

to it by the circuit supervisor before

sending them on to FSIS headquarters.

In Washington, FSIS’s facilities branch

reviews the information and decides

whether to approve or reject the

drawings and specifications, seek

further information, or return the

materials to the applicant. When

changes are made in the facilities of an

establishment, the changes must be

reflected in revised blueprints for the

establishment. The remodeled facilities

are then reviewed by the FSIS inspectorin-charge and the circuit supervisor to

assure compliance with the approved

blueprints and that there will be no

product adulteration.

Currently, about 2,900 blueprints

(both from new applicants and from

establishments remodeling their

facilities) are reviewed each fiscal year.

About 38% of the submissions, or about

1,100 sets, are rejected due to various

deficiencies. Most rejections result from

errors in paperwork rather than design

flaws that will compromise food safety.

The Agency works with the submitting

establishments to see that the

deficiencies are corrected. Under prior

approval, establishments are urged to

delay construction until drawings and

specifications have been approved, in

order to avoid costly changes in

construction or remodeling.

Experience has shown that FSIS prior

approvals are of limited value in

assuring good sanitation, because they

are limited in both scope—dealing only

with establishment facilities as

presented in drawings—and time—they

are given once, on the condition that

establishments will maintain a sanitary

operating environment after their

facilities are approved. Ultimately, the

establishments’ implementation of good

sanitation operating procedures on a

continuing basis is more critical than

the actual design of a facility. Also, with

the elimination of prior approval

requirements, production time that

previously was lost in obtaining FSIS

approval of blueprints and

specifications would become available

to the industry.

Under the proposal, establishments

would continue to be expected to

establish and maintain a sanitary

environment for slaughtering and

processing by adhering to the general

principles and requirements for lighting,

ventilation, drainage, plumbing, toilets,

and condensation found in §§ 308.3(a)–

(c), 308.4, 308.7, 308.8 (a) and (b),

381.46, and 381.47 of the meat and

poultry inspection regulations.

All official establishments (about

6,200 establishments), would be affected

by the proposal, except food irradiation

facilities. There is no requirement for

prior approval of blueprints for food

irradiation facilities, because only

prepackaged product is permitted to be

irradiated under current regulations.

Although FSIS’s prior-approval

procedures for drawings and

specifications would change under the

proposal, its sanitation standards would

not. Establishments would be

responsible for ensuring that the design

of facilities creates a sanitary

environment and that such an

environment can be and is maintained.

If field inspectors carrying out their

routine inspection tasks found product

to be adulterated or prepared, packed, or

held under insanitary conditions

whereby it may have been contaminated

with filth or may have been rendered

injurious to health because of deficient

facilities, all product subject to such

conditions would be either retained and

reworked or condemned, and the

establishment would be required to take

corrective action or cease operations. As

under current regulations, such

corrective action, which might involve

repair or reconstruction of facilities,

would be triggered only by an actual

finding of product adulteration or

insanitary conditions. Such a finding

would constitute evidence of deviation

from regulatory standards. Therefore,

FSIS is proposing to remove the current

requirements for prior approval of

facility drawings and specifications.

Requirements at 9 CFR 304.2(a), 308.2,

and 381.19(a)–(f) for submission of

blueprints and drawings before

inspection can be granted or changes

made in facilities at official

establishments would be eliminated.

Establishments would initiate and

complete construction without prior

approval by FSIS.

Although there would no longer be a

requirement for an establishment to

submit facility drawings and

specifications in applying for a grant of

Federal inspection, FSIS would

continue to have a specific process

through which the decision on granting

inspection would be made. This process

would still include an on-site review, or

‘‘walk-through,’’ of the establishment’s

facilities by the FSIS circuit supervisor

as part of the predecisional review of

the establishment’s capability to

produce ‘‘complying’’ product.

However, the decisionmaking process

would no longer include the review and

prior approval of establishment facility

blueprints and specifications by the

Agency. The on-site review would not

involve matching items on the

blueprints with the actual facilities

represented. Instead, the focus of the

review would be on the extent to which

the establishment is able to maintain a

sanitary environment for food

production. This change would be

intended to parallel other changes in

establishment-inspector relationships

that FSIS is contemplating in its

reinvention of meat and poultry

inspection.

If this proposal is adopted, FSIS

would plan to:

(1) maintain a small number of

personnel who would assist inspectors

in performing in their in-plant roles.

These roles would eventually include

the monitoring of establishmentoperated sanitation SOP’s and HACCP

systems;

(2) provide general guidance

regarding establishment layout and

design to assist establishments in

meeting food safety standards; and,

(3) publish one final edition of

Agriculture Handbook 570, ‘‘U.S.

Inspected Meat and Poultry Packing

Establishments: A Guide to

Construction and Layout’’, 1 and make

it available to industry as a guidebook

to construction of facilities. Handbook

570, an FSIS reference guide (not a set

of regulatory requirements per se), is

provided to assist industry, architects,

and inspectors.

A small staff in Washington would

maintain FSIS’s technical expertise and

capability in this important aspect of

food science and technology. This staff

would be responsible for keeping

abreast of developments in the field and

updating FSIS’s new, HACCP-oriented

guidelines and communicating

technical information to Agency

personnel. The Agency will not approve

industry decisions in these areas.

In addition, implementation of the

proposed Pathogen Reduction/HACCP

rule’s sanitation standard operating

procedures, would render priorapproval procedures unnecessary.
Federal Register / Vol. 61, No. 86 / Thursday, May 2, 1996 / Proposed Rules 19581

Establishment-operated sanitation

procedures and HACCP systems would

accomplish, without prior approval, the

same objectives as the FSIS prior

approvals. Thus, under HACCP-based

inspection, the FSIS prior approvals

could no longer be considered an

efficient and cost-effective way to

achieve sanitation objectives.

B. Equipment Approval

As in the case of the facilities

regulations, the regulations governing

equipment (9 CFR 308.5, 381.53) were

promulgated with a view to having the

Agency assure sanitation in

slaughtering, dressing, and processing

operations. Requirements for sanitary

equipment and utensils have been in

force since the 1906 Meat Inspection

Act. However, unlike prior approval of

facility blueprints and drawings, the

approval of types of equipment prior to

use has not always been a requirement.

Under regulations that have been in

force since 1975 (9 CFR 308.5, and

381.53), the FSIS Equipment Branch

formally evaluates equipment and

utensils proposed by manufacturers or

suppliers before they can be used in

official establishments to assure they

can be maintained in a sanitary

condition. The program focuses on

identifying and correcting problems

during the initial development of

equipment, instead of resolving

problems after equipment is put into

widespread use.

FSIS’s acceptance of new, modified,

or reconditioned equipment for use in

federally inspected meat and poultry

establishments is a two-step process.

First, FSIS Equipment Branch personnel

evaluate the design and construction of

equipment by reviewing assembly-type

drawings and corresponding parts and

material lists submitted to the Branch by

the equipment manufacturer. Then, if

necessary, FSIS inspectors review the

in-establishment operation of the

equipment and report their findings to

the Equipment Branch. Commercially

available equipment is accepted and

listed in an FSIS reference guide,

‘‘Accepted Meat and Poultry

Equipment,’’ 1 known as the FSIS

Equipment Book. Once equipment is

listed in this reference as acceptable, no

further approval is needed on an

establishment-by-establishment basis.

Certain categories of equipment, such as

simple tools and cleaning equipment,

are exempt from prior approval. Among

the types of equipment that are

evaluated through FSIS’s prior-approval

procedure are clean-in-place systems,

piping used with establishment

machinery, automatic eviscerators, heat

exchangers, smokehouses and ovens, air

compressors, and water recycling

equipment.

FSIS processes about 2,500 equipment

applications, rejections, and

acceptances each year. About 200

equipment applications are rejected on

first review for lack of sufficient

information. About 650 acceptance

decisions are based on the results of inplant trials. About 18 equipment

applications are rejected after in-plant

trials reveal deficiencies.

The principal cost of the priorapproval process to the private sector is

considered to be that resulting from lost

or delayed equipment sales caused by

delay in obtaining approval. This cost

falls mainly on equipment sellers and

manufacturers and can be considerable

if the introduction of promising new

technology is delayed. The productivity

of meat and poultry establishments

could also be adversely affected by

delays in approving efficient new

equipment.

Furthermore, FSIS’s one-time

approval does not address daily

operational issues such as proper

maintenance and adjustment of

equipment to prevent product

contamination. Such issues are covered

by the requirement that equipment and

utensils be of such material and

construction that they can be easily

cleaned to prevent product adulteration

(9 CFR 308.5, 381 subpart H), as well as

by other general requirements,

independently of any prior approval.

The prior-approval review for

equipment may sometimes involve the

evaluation of machinery, including

scientific instrumentation, that will not

itself have contact with a food product

or have other direct effects on health or

safety, but that may be part of an

innovative approach to food processing

or product safety. The Agency’s review

may delay testing or introduction of the

innovation by weeks or months. The

delay can be costly to a company in a

highly competitive environment.

FSIS is therefore proposing to

eliminate the requirement at 9 CFR

308.5 and 381.53 for prior evaluation

and approval of equipment and utensils

used in official meat and poultry

establishments. The general principles

and requirements for such equipment

and utensils provided at 9 CFR 308.5(a)

and 381.53(a) would be preserved.

Under this proposal, equipment and

utensils would still have to be

constructed so as to facilitate thorough

cleaning and operational cleanliness

and not adulterate edible product. Also,

they would still have to be constructed,

maintained, and used in a manner that

does not interfere with inspection.

However, FSIS would no longer

conduct its acceptance program before

equipment could be used in an official

establishment. Establishments would be

able to use equipment based on their

own evaluation of their ability to utilize

the equipment in a sanitary way. The

general requirements for equipment

already in the regulations (9 CFR 308.5

and 381.53) would not change. In its

inspection activities, FSIS would

continue to judge establishment

equipment by those same general

standards. Equipment must be

cleanable, it must be capable of being

disassembled and inspected, and it must

not interfere with inspection or

adulterate product. FSIS inspectors

would continue to reject equipment

they find posing a sanitary hazard.

For calendar year 1996, the Agency

will separate the general guidance

material from its list of approved

equipment and publish the guidance

material separately. The final edition of

the equipment list, which FSIS

published in 1995, is available to

current subscribers and to anyone who

requests a copy before the effective date

of the final rule.

Operational procedures and

appropriate sanitation process controls

would be developed by the inspected

establishment. In this area, as in

facilities, official establishments would

be required to meet the general

requirements prescribed in the

regulations, but would be allowed the

flexibility to determine the specific

steps to be taken to comply with those

requirements. The sanitation SOP’s

proposed for official establishments in

FSIS’s Pathogen Reduction/HACCP

proposal would provide plans for

applying the general principles for

maintaining sanitary conditions to

specific establishment situations. The

establishment would also be required to

maintain any controls appropriate to the

HACCP plans for the establishment’s

products (e.g., raw beef), such as making

sure the facilities and equipment

(structures and machinery for

evisceration) are designed, built, and

operated so that any necessary action

(sanitary dressing procedures) can be

taken at critical control points in the

HACCP plan.

The equipment prior-approval process

proposed here for elimination is to be

distinguished from the program,

announced by FSIS last year, for

reviewing experimentation with new

technologies (‘‘Guidelines for Preparing

and Submitting Experimental Protocols

for In-Plant Trials of New Technologies

and Procedures; 60 FR 27714; May 25,

1995) under commercial conditions.

The purpose of the new program is to
19582 Federal Register / Vol. 61, No. 86 / Thursday, May 2, 1996 / Proposed Rules

encourage the adoption by industry of

innovative technologies that will help

reduce the risk of foodborne disease.

The Agency has established procedures

(see FSIS Directive 10,700.1) for

reviewing protocols for experimentation

with new technologies in official

establishments if there is a possibility

the experimentation could adversely

affect product, environmental, or worker

safety, or interfere with inspection.

For example, in experiments

involving the artificial contamination of

carcasses with fecal matter to test the

effectiveness of a carcass cleaning

process, any products from these

carcasses must be removed from

commercial channels or reconditioned

to be wholesome or fit for sale. Protocols

for experiments involving the use of

materials that could pollute the

environment or affect worker safety

must include appropriate regulatory

citations or be accompanied by written

approval of the Environmental

Protection Agency or the Occupational

Safety and Health Administration.

Although new technologies can be

expected to include the use of

equipment, the FSIS review program is

primarily intended to enable the

experimentation to proceed rather than

to approve the equipment used.

Further Regulatory Reform

As stated in FSIS Docket #95–008A,

‘‘FSIS Agenda for Change; Regulatory

Review’’ (60 FR 67469; December 29,

1995), FSIS is reviewing all of its

regulations, policies, and inspection

procedures, including those concerning

establishment sanitation (as presented

in handbooks, notices, directives, etc.).

Although implementation of FSIS’s

proposal for sanitation SOP’s would not

depend on revisions to the Agency’s

sanitation regulations, because this is an

area where inspectors have traditionally

exercised discretion and provided direct

oversight and direction to

establishments, the Agency recognizes

the need to more clearly state its

performance standards in this area. The

Agency believes that the regulations can

be made much clearer in describing the

establishments’ responsibilities, that

doing so will relieve inspectors of much

of the routine work they do that should

be done by establishment employees,

and that inspection resources can then

be freed up and reapplied in performing

new, HACCP-related food safety

functions.

C. Partial Quality Control Programs

Quality control, in general, is a

planned, documented system of

activities intended to assure the stability

of processes and uniformity of products.

Quality control programs are based on

the assumption that there is normal

variation in any process and that the

process is under control if that variation

is not exceeded. Quality control is used

in manufacturing to assure that

components and products from ball

bearings to microcomputer circuits,

which are made in huge quantities, will

all have the same desired

characteristics. In the food industry,

quality control systems are used in

processing operations to make sure that

each product produced, from TV

dinners to hotdogs, will be exactly the

same—will have the same content,

flavor, color, texture, and so forth, no

matter how many thousands are made

in a production run.

In applications relevant to food safety,

quality control programs can be used to

maintain normal process variation

around a standard, such as a timetemperature standard for cooked beef or

a moisture-protein ratio for dry sausage.

If the expected variation is exceeded,

corrective action must be taken to

restore process stability and ensure food

safety.

Under current FSIS regulations, a

company may choose to place all of the

processes and products in an

establishment under a comprehensive

quality control system. Such a system,

known as total quality control (TQC),

integrates an establishment’s quality

development, maintenance, and

improvement efforts to enable

engineering, production, marketing, and

service to take place at the most efficient

levels that meet consumer expectations.

A quality control system for only one

process or product in an establishment

is known as a partial quality control

system (PQC). The quality control

systems are, in a sense, precursors of the

HACCP system FSIS envisions in that

they are establishment-operated process

control systems.

In 1980, FSIS promulgated regulations

establishing procedures for meat and

poultry establishments to follow in

obtaining Agency approval of their

voluntary TQC and PQC systems. FSIS

approved several thousand PQC

programs during the 1980’s. Since 1990,

FSIS has approved an additional 4,000

PQC programs and more than 3,000

amendments to those programs. There

are now more than 8,200 approved PQC

programs.

An approved quality control program

is typically a voluntary activity in

which an establishment is allowed to

establish its own control procedures

(provided these conform with the

regulations). Approved PQC programs

have provided FSIS with a tool or

method for maintaining assurances that

label claims, composition declarations,

and many other standards are met, and

that food products are safe. They also

allow FSIS to regulate processes for

which specific criteria have not been

prescribed by the regulations.

Verification inspection of the PQC

programs enables FSIS to determine

whether or not the programs are

functioning. If they are shown to be

malfunctioning, the establishment takes

corrective action.

There are several types of FSISapproved PQC programs; most are

voluntary, some are mandatory.

Voluntary PQC’s generally fit into two

broad categories. The first type includes

those that need not be used to produce

a product. For example, an approved

PQC program for controlling the

percentage of fat and water in a product

is not necessary for an establishment to

be allowed to make hotdogs. The

establishment could produce the

product without the PQC program.

However, the PQC program helps assure

that the establishment produces the

hotdog and other products in

accordance with the regulatory

standards. Without a PQC program, an

establishment runs a higher risk of

producing noncompliant product

subject to retention by the FSIS

inspector.

The second type of voluntary PQC

includes product labeling-related

programs intended to ensure production

of a product that is in compliance with

a compositional requirement. For

example, some PQC’s are designed to

meet the requirements of vignette

labeling (labeling that shows an image

of the food product either as it is in the

container or as served, such as labeling

that shows a specific number of

meatballs in or pepperoni slices on a

product); other PQC’s are designed to

comply with product composition

requirements that must be met if certain

labeling is used (such as the protein-fatfree requirement for a product labeled

‘‘ham, water added’’).

There are also mandatory PQC

programs. Some are compulsory for

certain types of food processing or are

required to produce certain products;

others are required for an establishment

to operate under a certain inspection

system. For example, the PQC for online carcass quality control is a

mandatory component of the New Line

Speeds (NELS) poultry inspection

system. FSIS also requires approved

PQC programs for the testing of new or

not-previously-approved antimicrobial

treatments in slaughtering

establishments (to monitor equipment

and process controls for experimental

design and safety reasons); for product
Federal Register / Vol. 61, No. 86 / Thursday, May 2, 1996 / Proposed Rules 19583

identification and control during

slaughter, dressing, and processing to

support labeling statements; and for

monitoring chlorine concentrations in

product intended for export to Canada.

There are also PQC programs to

control products for so-called economic

factors. These programs are intended to

prevent the marketing of products that

are misbranded or that lack the quality

or value that the product standard

imposes. These economic PQC’s are

intended to serve two main purposes:

(1) to take the place of lot inspection of

product (the sampling and testing of a

shift’s production for certain

characteristics) by the FSIS inspector;

and (2) to assure that products meet

requirements associated with their

labeling.

Establishments operating the first type

of economic PQC generate data that are

subject to random verification by the

FSIS inspector. Examples of these

include programs for net weight, fat and

water in frankfurters, and boneless meat

(mainly for aesthetic defects). An

establishment operating under a PQC for

net weight keeps records of its checks

and corrective actions to avoid lot

inspection. Under PQC’s for fat and

water in frankfurters, establishments

keep ingredient records by lot and

results of laboratory tests for random

verification by FSIS inspectors. An

establishment operating a PQC for

boneless meat inspections does its own

on-line inspections and keeps records.

The FSIS inspector randomly selects

samples of product the establishment

has already inspected to assure that the

establishment’s records are accurate.

Examples of the second kind of

economic PQC include those for

controlling the amount of added

ingredients in corned beef, the amount

of basting or marinating solutions in

certain poultry products, and the

truthfulness or accuracy of certain label

claims. The PQC programs for basting or

marinating solutions in certain poultry

products assure that the amount of

added solution in such products does

not exceed the standards set forth in 9

CFR 381.169. The establishment

accomplishes the objective of these

programs by controlling the pumping

procedure at the time of product

formulation.

The PQC program for an

establishment making a product bearing

a label claim that only sirloin cuts have

been used in the meat portion of the

product must include an approved

procedure with records for assuring the

veracity of the claim. The PQC’s for

vignette labeling assure that product

characteristics conform with the graphic

display on the product label, in

accordance with 9 CFR 317.8(a) and

381.121. If a product label shows four

meat balls, the PQC for the product

would have to document that each

package contains four meat balls. The

programs are carried out through inplant sampling and visual inspection,

with verification checks by FSIS

inspectors.

Although about 70 percent of PQC’s

are intended to support labeling claims,

not all have this purpose. Some support

alternative processing procedures that

have become so routine that very

specific guidelines are followed in

preparing the PQC program. FSIS has

developed 64 guidelines detailing the

essential elements of the most

commonly used PQC programs. Many of

these are procedures that substitute for

more direct controls on economic or

quality features of products such as

declared count, vignette labeling, or the

‘‘popping’’ of pork rinds. These are not

connected with food safety.

Under the current system, no matter

how routine the preparation, review,

and subsequent approval of the PQC

program, each must be submitted to

either the Washington office or a

Regional Office and be stamped

‘‘approved.’’ FSIS has assigned 11 staffyears to the review and approval of

establishment PQC programs.

Approximately 1,800 quality control

programs and amendments are handled

each year by the Regional Offices;

approximately 50 programs for complex

processes or requiring specialized

knowledge (such as programs for

thermal processing) are approved each

year by the Washington office. The

purpose of the review is to assure that

the programs contain all the necessary

elements of a quality control program

and are appropriate for their intended

purpose. The programs must describe

the product and process for which they

are intended, and the materials to be

used. They must identify any hazards,

define process deviations, indicate the

control points to be monitored, and

procedures for checking processes. They

must also state the methods for

gathering data and determining results,

and the corrective actions to be taken if

process deviations are found. Finally,

the programs must bear the names and

locations of responsible establishment

quality control officials and authorized

USDA employees must have access to

records generated by the programs. The

time for a PQC prior approval to be

obtained is typically 2 weeks.

FSIS considers this administrative

burden on the industry and the Agency

to be unnecessary to achieve food safety

or nonadulteration objectives. Under

HACCP-based inspection,

establishments would assume

responsibility for developing process

control procedures in advance without

having to depend on Agency approval

for every step in their procedures. FSIS

would evaluate or verify the

effectiveness of the procedures through

normal inspection operations and take

action when necessary to prevent

product adulteration.

By relying on general requirements for

the design of all PQC programs, but not

requiring prior approval of such

programs, FSIS could use its resources

(staff-years) more efficiently and

effectively than it does now in its PQC

prior-approval activities. This approach

would also provide establishments with

ample flexibility to develop their own

process control techniques.

For these reasons, FSIS is proposing

to eliminate the requirements at 9 CFR

318.4(d) and 381.145(d) for prior

approval of PQC programs. Prior

approval of most voluntary or

‘‘economic’’ PQC programs would be

discontinued and an unnecessary

regulatory burden would thus be lifted.

However, the current requirements

governing the content of PQC programs

would remain (§§ 318.4(d)(2)(i) and

381.145(d)(2)(i)), as would existing

mandatory-PQC requirements. Prior

approval of PQC programs would be

eliminated for all but a few of the

mandatory PQC programs, such as those

required for certain slaughter inspection

systems, or those requiring special

expertise, such as PQC’s for thermal

processing or other complex processing.

The Agency, however, is planning to

change these areas of its regulations to

eliminate prior reviews and make them

compatible with HACCP. This proposal

would eliminate at least 90 percent of

the approximately 1,900 PQC

submissions made to FSIS each year.

Cross-references to the existing priorapproval requirement would also be

eliminated (in 9 CFR 318.7(b)(3),

318.7(c)(4), 317.21, 318.19, 318.309,

319.5, 319.104, 381.121d, and 381.309).

In addition, the regulations would be

revised to provide (in 9 CFR

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

the design of PQC programs to assure,

with at least 85 percent statistical

confidence, that the lot or process

means do not exceed the product or

label limits to which the PQC programs

apply. This requirement, which is

already observed in the design of FSISapproved PQC programs now in use,

would also provide for control of

individual sublot samples to within

plus-or-minus 3 standard errors

(standard deviations of the sampling

distribution) of the process mean. At

least 3 sublot samples representing a
19584 Federal Register / Vol. 61, No. 86 / Thursday, May 2, 1996 / Proposed Rules

production lot would have to be drawn

for each lot of product subject to the

PQC program. Further, each sublot

sample would have to contain at least 5

samples representing the sublot. No

individual sample mean or sublotsample mean could be more than 3

standard errors above or below the

process mean. (A lot is ordinarily a

shift’s production, but may be defined

differently by different establishments.

A sublot is a fraction of a lot, and may

represent an hour’s production, or a

quarter-hour’s production, or other

portion of a production lot from which

quality control samples may be drawn.)

For example, a PQC program prepared

according to the FSIS guideline for the

injection of corned beef labeled as

having 30-percent added solution would

be designed to assure with greater than

85 percent confidence that the 30-

percent limit is not exceeded. In other

words, the lot average must not be above

this limit. A batch, a portion of the lot,

must not be more than 1.2 percent above

the declared value on the label. Samples

drawn from individual batches of the

production lot would have to show that

the 3-standard-errors limit (in this

example, 1.2 percent, or 31.2 percent

added solution) is not exceeded.

PQC programs thus designed would

provide process control, and hence a

degree of food safety or food

nonadulteration assurance, that is

comparable to that provided currently

by PQC programs individually approved

by FSIS. Official establishments would

have a less prescriptive set of conditions

to meet in designing and implementing

their PQC programs, and more latitude

for innovation. Because the unnecessary

regulatory burden of prior approval

would no longer exist, establishments

would be able to implement their

programs sooner than the current priorapproval process allows.

Establishments would be required to

comply with the requirements in

proposed 9 CFR 318.4(d)(2)(ii) and

381.145(d)(2)(ii) in designing their PQC

programs. Prior approval would still be

required for quality control programs

and systems referred to elsewhere in the

regulations (e.g., 9 CFR 318.4 (c), (e), (f),

and (h); and 381.145 (c), (e), (f), and (h)),

including those associated with, and

required for, such slaughter inspection

systems as the NELS and the NTIS (9

CFR 381.76(c)). Proposals addressing

these programs and systems will be

published in the near future. This

proposed rule would amend paragraphs

9 CFR 318.4(e) and 381.145(e) to delete

references to prior approval

requirements for PQC programs.

Proposed 9 CFR 318.4(d)(1) and

381.145(d)(1) would retain the current

requirement for official establishments

with PQC’s to make the programs and

data and information generated by them

available to FSIS inspectors. Formal

notification would not be required

because establishment operators

typically notify FSIS personnel of the

products and processes operated under

establishment-operated PQC programs

during their regular interactions with

FSIS personnel. Establishment operators

recognize the advantage of making their

quality control programs and data

available to FSIS. FSIS personnel who

have not been advised that a product is

being produced under a PQC program

would perform traditional lot inspection

procedures, rather than quality control

evaluation and verification tasks. The

results of lot inspection may differ

technically from those obtained under a

PQC inspection. A product lot could be

subject to retention even though the

process for the product is under control,

requiring no corrective action to restore

controls.

FSIS, therefore, is not proposing to

terminate the use of PQC’s as a

mechanism for organizing the collection

and review of data which document

outcomes. FSIS is, however, proposing

to end its role as the approver of

paperwork describing data collection to

support alternative processing

procedures.

Establishments operating under

approved PQC programs would

continue to keep the programs on file

and available for use by FSIS

employees. FSIS would adjust

verification inspection tasks to reflect an

approach that is appropriate to the

process control procedure being used by

the establishment.

It is likely that establishments will

find the continued use of PQC programs

to be advantageous under the inspection

system envisioned by the Agency in its

‘‘Pathogen Reduction/HACCP’’

proposal. Although most PQC programs

currently used by inspected

establishments control products and

processes for economic factors, e.g., fat

and moisture content or the amount of

marinating solution a product can

absorb, there are some that have public

health implications. Such PQC

programs would be compatible with

establishment-operated HACCP plans

and establishments would continue to

use them under HACCP-oriented

inspection. Moreover, because

establishments operating HACCP plans

would be concerned about maintaining

stability in all their processes, they

would be likely to continue many of

their economic PQC’s or develop new

ones. But they would no longer need

prior approval from FSIS before

implementing them.

FSIS considers relief from the priorapproval aspect of these PQC’s to be the

first in a series of steps to realign

inspection and company responsibilities

in the area of process control systems.

As FSIS progresses in its review and

adjustment of its inspection regulations,

it will take more steps in this area.

Regulations will be rewritten as

performance standards, facilitating

innovation. Establishments will be free

to develop establishment-specific

approaches as long as the regulatory

objectives are met. Therefore, as FSIS

reinvents its regulations in accordance

with its stated plans (see docket #95–

008A, ‘‘FSIS Agenda for Change;

Regulatory Review’’), the need for

Agency-developed guidelines should

decrease. Companies will be able to call

on a full range of technical resources to

develop alternatives and design systems

to demonstrate their efficacy.

Other Prior Approvals

This proposal addresses the removal

of the requirements for prior approval of

facility blueprints, equipment, and PQC

programs for inspected meat and

poultry establishments. In addition to

the prior approvals discussed in this

proposal, FSIS plans to eliminate its

remaining centralized prior approval

procedures. These include the

procedures for: PQC’s for water reuse,

on-line PQC’s used in the NELS and

NTIS poultry inspection systems,

nonfood compounds and proprietary

additives, and possibly labeling. FSIS

intends to publish proposals on these

topics in the near future.

Like the regulations governing meat

and poultry inspection, the egg products

inspection regulations, promulgated

under the Egg Products Inspection Act

(21 U.S.C. 1031, et seq.) (EPIA), also

contain prior-approval procedures for

facilities and blueprints (7 CFR 59.146,

59.500, 59.506, 59.520, 59.538, 59.540,

and 59.550), labels (7 CFR 59.411),

equipment and utensils (7 CFR 59.502,

59.506, 59.515, 59.520, 59.522, 59.540,

59.540, 59.547, and 59.552), nonfood

compounds (7 CFR 59.504 and 59.552),

and various processing procedures for

egg products. FSIS is not prepared to

propose to remove these requirements

because FSIS has only recently acquired

responsibility for administering the

EPIA and the egg products inspection

regulations promulgated under that Act.

FSIS has just begun reviewing the priorapproval requirements in the egg

products regulations to see which, if

any, are still necessary and should be

maintained, and which are obsolete or

burdensome and should be amended or
Federal Register / Vol. 61, No. 86 / Thursday, May 2, 1996 / Proposed Rules 19585

rescinded. As appropriate, FSIS will

propose changes in the egg products

inspection regulations.

Executive Order 12778

This proposed rule has been reviewed

under Executive Order 12778, Civil

Justice Reform. States and local

jurisdictions are preempted under the

Federal Meat Inspection Act (FMIA) and

the Poultry Products Inspection Act

(PPIA) from imposing any marking or

packaging requirements on federally

inspected meat and poultry products

that are in addition to, or different than,

those imposed under the FMIA or PPIA.

States and local jurisdictions may,

however, exercise concurrent

jurisdiction over meat and poultry

products that are outside official

establishments for the purpose of

preventing the distribution of meat and

poultry products that are misbranded or

adulterated under the FMIA or PPIA or,

in the case of imported articles, which

are not at such an establishment after

their entry into the United States.

This proposed rule is not intended to

have retroactive effect.

If this proposed rule is adopted,

administrative proceedings will not be

required before parties may file suit in

court challenging this rule. However,

the administrative procedures specified

in 9 CFR §§ 306.5 and 381.35 must be

exhausted prior to any judicial

challenge of the application of the

provisions of this rule, if the challenge

involves any decision of an FSIS

employee relating to inspection services

provided under the FMIA or PPIA.

Executive Order 12866 and Effect on

Small Entities

This proposed rule has been

determined to be significant and was

reviewed by OMB under Executive

Order 12866.

FSIS is proposing to eliminate prior

approval requirements for establishment

drawings and specifications, equipment,

and certain partial quality control

programs. Concurrent with this

proposal, FSIS would restructure

inspection activities to focus more

attention on the ability of

establishments to maintain a sanitary

environment. These actions, in addition

to implementation of the sanitary

standard operating procedures, which

were proposed by the Agency as part of

the Pathogen Reduction/HACCP

proposal, would provide the industry

the flexibility for creating and

maintaining a sanitary working

environment without prescriptive

command-and-control requirements.

Removing these requirements would

affect establishments subject to official

inspection, firms producing and selling

equipment currently subject to prior

approval, firms providing expediting

services to businesses seeking prior

approval, and consumers. The proposal

would reduce demands on FSIS

resources which could be redirected to

functions more critical to improving

food safety.

Alternatives to this rulemaking that

FSIS considered for facilities and

equipment prior approvals included

development by FSIS of detailed

standards to be published in booklets

with periodic updates, recognizing

industry organizations as prior approval

authorities, and establishing general

performance standards similar to FDArecognized good manufacturing

practices. Another alternative which

would have provided these services on

a voluntary, user-fee basis, was

considered but not adopted. FSIS has

chosen the option of eliminating prior

approval requirements while

maintaining the general food safety

standards in the existing regulations.

For PQC prior approvals, the

alternatives to no rulemaking were

market sampling of finished products,

mandating additional in-plant controls,

sampling of finished products for

chemical analysis, and maintaining

general requirements and a standard for

the design of PQC programs. The last

option was chosen because it would

provide official establishments with the

most flexibility in implementing PQC

programs.

Benefits of the Rule

Approximately 6,200 federally

inspected meat and poultry

establishments would no longer be

required to submit blueprints, drawings,

and specifications to FSIS for review

and approval. FSIS reviewed about

2,900 submissions in FY 1994. The cost

of receiving FSIS approval for drawings

and specifications and changes they

represent includes the administrative,

mailing, and labor costs associated with

preparing the required Agency forms.

The labor cost is estimated at 30

minutes for each submission. Assuming

an hourly wage or per-hour salary of

$20-$25 for each person submitting

blueprints and specifications and the

FSIS form, the annual cost to the

industry for making these submissions

is in the range of $30,000 to $40,000.

This, then, is an estimate of the savings

accruing to industry from removing the

requirement for prior approval that FSIS

is proposing.

As many as 1,500 establishments per

year submit for approval PQC programs

or amendments to PQC programs. FSIS

receives a total of 1,900 submissions

each year. A typical PQC program,

prepared according to FSIS guidelines,

can be written up in about 4 hours by

an individual earning $20 to $25 per

hour. Thus, removing the requirement

for prior approval of PQC plans is

estimated to save the industry $150,000

to $190,000 per year.

FSIS receives approximately 2,500

submissions for approval of equipment

each year. The costs of these

applications generally fall on equipment

manufacturers rather than the meat and

poultry firms subject to inspection,

although a few meat and poultry

establishments make some of their own

equipment or equipment modifications.

FSIS has no estimate that specifically

pertains to the costs to manufacturers of

applying for equipment approval, but

these costs are assumed to be

comparable to the costs to official

establishments of submitting blueprint

and establishment specification

approvals. FSIS recognizes that actual

costs to firms seeking equipment

approval may differ and welcomes

comments on this. Based on 30 minutes

per submission, a labor cost of $20–$25

per hour, and 2,500 submissions

annually, the annual cost savings from

removing the prior approval

requirement for equipment would be in

the range of $25,000 to $32,500. In

addition, approximately 650

applications for approval are contingent

on in-plant trials. These trials involve

some added costs to manufacturers and

meat and poultry establishments, but

the Agency has no estimates of these

costs to include in this analysis. FSIS

invites commenters to present

information indicating what these costs

are.

The proposal to eliminate blueprint

prior approvals would remove a source

of income for approximately 20 small

firms that represent official

establishments for the purpose of

labeling and blueprint approval. These

firms are known as ‘‘expediters.’’ It is

estimated that approximately 20 percent

of the annual blueprint submissions

(about 600) are made to the Agency

using the services of expediters. The

estimated annual total value of

blueprint expediting is about $240,000

for the companies involved. While this

would be lost income to the expediters,

it would be a transfer to meat and

poultry firms, which is not a social cost

of the proposed rule.

The social benefits directly resulting

from the elimination of prior approval

requirements as proposed in this

rulemaking are indicated in Table 1.

There would be additional but

unquantifiable social benefits from the

proposals to eliminate prior approvals.
19586 Federal Register / Vol. 61, No. 86 / Thursday, May 2, 1996 / Proposed Rules

These benefits derive from efficiencies

arising from fewer demands on

management, greater incentives to adopt

innovative practices, and the enhanced

ability to make changes quickly which

the prior approval system and its

inherent delays inhibit. Also, the delays

inherent in the prior approval process,

which can be translated into lost

production time, would be eliminated.

However, it is unlikely that an

inspection finding of adulterated

product or insanitary conditions under

the amended regulations would result in

increased costs to the industry for

rebuilding or remodeling facilities.

Establishments planning substantial

investments in new construction

typically consult with local authorities

and experts with up-to-date knowledge

of food establishment construction

before beginning major projects.

In addition to the benefits to firms

from elimination of these prior approval

requirements, FSIS could be expected to

benefit by reallocating about $2.3

million to high priority food safety

needs. Currently, the Agency allocates

about 15 staff-years ($750,000) to

reviews of equipment, 20 staff-years

(about $1 million) to reviews of

drawings and specifications, and 11

staff-years ($550,000) to review and

approval of PQC programs. The true

social benefits to be expected are the

improvements in food safety that would

logically flow from reallocating these

resources to more important food safetyrelated tasks.

Costs of the Proposed Rule

As is currently the practice,

inspectors would continue to require

establishments to take corrective action

or cease operations if any product has

been adulterated or prepared, packed or

held under insanitary conditions

whereby it may have been contaminated

with filth or may have been rendered

injurious to health, because of deficient

facilities and equipment. Corrective

action, which might include

reconstruction, remodeling, and

redesign would only be triggered by an

actual finding of product adulteration or

insanitary conditions. However, it is

unlikely that this proposal will increase

the level of inspection findings that

result in reconstruction, remodeling,

and redesign of facilities and

equipment.

Currently, facility and equipment

plans submitted to FSIS for prior

approval are rejected due either to errors

in paperwork or to deviation from

specific design criteria developed by

FSIS. Under the proposal,

establishments would not have to

submit applications for approval.

Instead, establishments would be

permitted to initiate and complete

construction or introduce new

equipment without submitting any

paperwork to FSIS. In addition, FSIS

would eliminate design-related criteria

currently utilized to evaluate the

acceptability of facilities and

equipment. Inspectors would no longer

require establishments to incur costs for

reconstruction, remodeling, and

redesign, because the actual facility or

piece of equipment does not match a

specified design criterion, blueprint, or

equipment specification.

In the absence of prior approval, FSIS

would focus inspection on whether

establishments are maintaining a

sanitary environment. Under this

proposal and the proposed rule on

sanitation standard operating

procedures, establishments would

assume greater control over their

production practices to ensure that a

sanitary environment is maintained.

Currently, many establishments utilize

the services of knowledgeable

architects, engineers, and other experts

to design facilities and equipment for

use in meat and poultry establishments.

Under prior approval, these experts

ensure, among other things, that FSIS

design specifications are met. Without

prior approval, establishments may

require these experts to provide more

information on the procedures

necessary for maintaining facilities and

equipment in a sanitary condition,

which could increase the costs for these

services. However, this is consistent

with the need for the industry to assume

greater responsibility for its operations.

Any cost increases for these services

would be commensurate with the

transfer of responsibility from FSIS to

the industry, and would not be a social

cost attributable to the rule.

TABLE 1.—BENEFITS TO FIRMS FROM ELIMINATING PRIOR APPROVAL REQUIREMENTS

Action Firms with more than

500 employees

Firms with fewer than

500 employees All firms

Remove blueprint and specification approval .......................................... $1,800–$2,400 $28,200–$37,600 $30,000–$40,000

Remove equipment approval ................................................................... $2,500–$3,250 $22,500–$29,250 $25,000–$32,500

Remove PQC approval ............................................................................ $9,000–$11,400 $141,000–$178,600 $150,000–$190,000

Total ............................................................................................... $13,300–17,050 $191,700–$245,450 $205,000–262,500

Regulatory Flexibility Assessment

The Administrator has determined

that, for the purposes of the Regulatory

Flexibility Act (5 U.S.C. 601–12), this

proposed rule would not have a

significant economic impact on a

substantial number of small entities.

The entities that would be affected by

this proposal are inspected meat and

poultry establishments, equipment

suppliers, and companies representing

official establishments to the Agency for

the purpose of obtaining blueprint

approvals. Most of these are small

entities.

The proposed rule is expected to have

a beneficial effect on small and large

entities, on both those regulated under

the FMIA and PPIA and some that are

not regulated under the inspection laws

but which are affected by the Agency’s

review of their products, e.g., suppliers

of equipment used in inspected meat

and poultry establishments.

There are about 5,800 federally

inspected small establishments. In this

analysis, FSIS is using the Small

Business Administration (SBA) business

size standards (at 13 CFR 121.601) for

meat packing establishments,

establishments that produce sausages

and other prepared meats, and poultry

slaughtering and processing

establishments. A small establishment

in any of these categories is considered

to be one with 500 or fewer employees.

Under current regulations, all official

establishments are required, as a

condition of receiving inspection

services, to submit blueprints, drawings,

and specifications of new or remodeled

facilities to FSIS for review and

approval. Under this proposal, the

establishments would, of course, not be

spared the cost of preparing for

themselves blueprints and

specifications for construction and

major installations. However, they

would no longer bear the cost of

submitting these drawings and

specifications to the Agency for review
Federal Register / Vol. 61, No. 86 / Thursday, May 2, 1996 / Proposed Rules 19587

because the requirement to do so would

be eliminated.

The savings to be obtained by

eliminating FSIS approval for drawings

and specifications and the changes they

represent includes the administrative

and mailing costs and the time

(resources) required to fill out the

required Agency form (‘‘Submission and

Approval of Plans and Specifications,’’

FSIS –5200–S), which is estimated at 30

minutes each submission. As mentioned

above, the annual savings to the meat

and poultry products industry from

eliminating the requirement of making

the submissions would be in the

neighborhood of $30,000–40,000. FSIS

does not consider this savings to be

significant. But in addition to such

direct savings, the largest potential

savings to the industry resulting from

the prior approval process for blueprints

and specifications would be those

associated with the elimination of

delays—of up to several weeks per

submission—in obtaining approval.

This estimated delay includes the time

needed to resolve disagreements over

plans and specifications, should such

disagreements arise between the Agency

and the establishment. This savings

could be significant for some small

entities, but there is no information to

indicate that it would be so for a

substantial number of them.

The savings would not be significant

for at least two reasons. First,

establishments engaged in construction

projects plan for the eventuality of an

FSIS review, or at least are advised by

knowledgeable food establishment

architects and engineers to build FSIS

review time into their project timelines.

Costs are minimized because delays that

do occur are anticipated. Second, under

the current prior review and approval

system, the Agency is able to exercise

discretion expediting reviews of

blueprints and facilities in specific cases

to prevent economic hardship from

occurring. The proposal is intended to

eliminate the costs attributable to the

delays associated with prior review and

approval.

While eliminating the cost of

blueprint prior approvals to small

establishments producing meat and

poultry products, the proposal would at

the same time remove a source of

income for about 20 small expediting

firms that represent official

establishments for the purpose of

labeling and blueprint approvals. These

expediters are frequently able to shorten

the time for these approvals and reduce

the rejection rate on submissions

because of their knowledge of Agency

requirements and proximity to Agency

offices. As mentioned above, the

estimated annual total value of

blueprint expediting is about $240,000

for the companies involved. This is a

small part of the expediters’ total

business, which is mainly that of

expediting label approvals and

consulting work. These 20 entities, in

any event, do not constitute a

substantial number of small entities

unfavorably affected by this rule.

By the same reasoning that the

Agency used to determine that these

prior approvals do not serve to increase

the safety of meat and poultry products,

the expediting activities of these firms

that will be reduced by the rule would

no longer be a productive use of

resources. These firms may, however,

experience an increased demand for

their consulting services from inspected

establishments who depended upon the

Government’s prior approval to assure

they were in compliance with the

regulations, who now need help from a

third party to assure they are in

compliance with the regulations.

The equipment acceptance procedure

principally affects manufacturers or

other vendors of equipment. The

equipment manufacturers range in size

from small to large concerns and, under

the current regulations, depend on FSIS

prior approval to be able to sell their

products to inspected establishments. It

is estimated that up to 90 percent of the

equipment manufacturers and other

applicants for FSIS equipment

acceptance are small entities. According

to the SBA business size standards (13

CFR 121.601), a small food products

machinery manufacturer is one that

employs 500 or fewer people.

Also favorably affected by the

approval process are inspected

establishments that may require

machinery or other equipment to

improve or continue their operations.

As is the case in the blueprint review

process for inspected facilities, the

savings from avoiding a delay before

installation and operation of a newly

developed piece of equipment, although

it could be significant for a few entities,

large or small, but will not be significant

for most establishments.

Finally, FSIS has determined that the

proposal to eliminate prior approval of

most voluntary PQC programs would

not have a significant economic impact

on a substantial number of small

entities. Both large and small

establishments subject to FSIS

inspection would be permitted to

continue to develop and implement

PQC programs for their products and

processes but would no longer be

required to submit the PQC’s to FSIS for

review and approval in advance of use.

Accordingly, the administrative delay

for review that occurs under the present

system would be eliminated.

It takes a minimum of 2 weeks for the

Agency to review a typical PQC

program, and as many as 1,500

establishments per year submit such

programs or amendments to programs—

a total of nearly 1,900 submissions per

year—and about 90 percent of these

establishments could be regarded as

small entities. Therefore, roughly 1,100

establishments would avoid the costs

associated with having to wait a

minimum of 2 weeks for PQC approval,

but it is not possible to identify what

costs would be saved under these

circumstances.

For these reasons, the Administrator

has determined that this proposal would

not result in a significant economic

impact on a substantial number of small

entities. The economic impact on such

entities would in most cases involve the

elimination of certain costs—some

quantifiable, some not quantifiable—

associated with doing business subject

to Federal regulation and hence would

be beneficial to those entities. Though

non-quantifiable, increasing the benefits

that come from reducing an

establishment’s dependence on

Government decisions is an important

objective of the proposed rule.

Paperwork Requirements

FSIS has reviewed the paperwork and

recordkeeping requirements in this

proposed rule in accordance with the

Paperwork Reduction Act. This

proposed rule would substantially

reduce ‘‘reporting’’ requirements for

official establishments and other

entities. FSIS estimates the total

reduction in reporting to be 4,291

burden hours. The reductions would

occur in the following information

collection reports:

• 0583–0082, ‘‘Meat and Poultry

Inspection; Application for Inspection,

Sanitation, and Equipment

Requirements and Exemptions’’:

Establishments subject to inspection

would no longer have to submit

blueprints and specifications along with

Form FSIS–5200–5. The response time

is estimated to be 30 minutes, and there

are 701 total burden hours approved by

the Office of Management and Budget

(OMB) for this activity. Therefore, FSIS

would request OMB to remove the 701

approved burden hours.

• 0583–0082, ‘‘Meat and Poultry

Inspection; Application for Inspection,

Sanitation, and Equipment

Requirements and Exemptions’’: FSIS

prior approval would no longer be

required for the products of these

companies that are used in official

establishments. The response time is
19588 Federal Register / Vol. 61, No. 86 / Thursday, May 2, 1996 / Proposed Rules

estimated to be 30 minutes for the prior

approval of equipment. There are 2,990

total burden hours approved by OMB

for this activity. Therefore, FSIS would

request OMB to remove the 2,990

approved burden hours.

• 0583–0089, ‘‘Processing Procedures

and Quality Control Systems’’:

Establishments could continue to

develop and implement PQC programs

according to Agency guidelines. These

establishments, with the exception of

poultry irradiation facilities, would no

longer be required to submit a letter

requesting approval of a proposed PQC

program and a copy of the program to

the Agency for approval prior to

implementation. The response time is

estimated to be 30 minutes for writing

the request letter and sending the PQC

program to FSIS. There are 600 total

burden hours approved by OMB for this

activity. In consideration of poultry

irradiation facilities 60 hours of burden

would remain. FSIS does not foresee

more than two irradiation facilities

requesting FSIS approval of PQC

programs. Therefore, FSIS would

request OMB to remove 540 approved

burden hours. The burden hours for

PQC program development and

reporting would remain the same.

Copies of this information collection

assessment can be obtained from Lee

Puricelli, Paperwork Specialist, Food

Safety and Inspection Service, USDA,

South Agriculture Building, Room 3812,

Washington, DC 20250.

Comments are invited on: (a) whether

the proposed collection of information

is necessary for the proper performance

of the functions of the Agency,

including whether the information will

have practical utility; (b) the accuracy of

the Agency’s estimate of the burden of

the proposed collection of information

including the validity of the

methodology and assumptions used; (c)

ways to enhance the quality, utility, and

clarity of the information to be

collected; and (d) ways to minimize the

burden of the collection of information

on those who are to respond, including

through the use of appropriate

automated, electronic, mechanical, or

other technological collection

techniques or other forms of information

technology. Comments may be sent to

Lee Puricelli, Paperwork Specialist (see

address above), and to the Desk Officer

for Agriculture, Office of Information

and Regulatory Affairs, Office of

Management and Budget, Washington,

DC 20253.

Comments are requested by July 1,

1996. To be most effective, comments

should be sent to OMB within 30 days

of the publication date of this proposed

rule.

List of Subjects

9 CFR 304

Drawings, Information to be

furnished, Grant or refusal of

inspection, Meat inspection.

9 CFR 308

Meat inspection, Sanitation.

9 CFR 317

Meat inspection, Reporting and

recordkeeping requirements.

9 CFR 318

Meat inspection, Establishmentoperated quality control.

9 CFR 319

Food grades and standards, food

labeling.

9 CFR 381

Poultry and poultry products.

For the reasons set forth in the

preamble, FSIS is proposing to amend 9

CFR Chapter III, the Federal meat and

poultry inspection regulations, as

follows:

PART 304—APPLICATION FOR

INSPECTION; GRANT OR REFUSAL

OF INSPECTION

1. The authority citation for Part 304

would be revised to read as follows:

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

2.53.

2. The heading of section 304.2 would

be revised to read as follows:

§ 304.2 Information to be furnished; grant

or refusal of inspection.

* * * * *

3. Section 304.2 would be amended

by removing paragraph (a) and

redesignating paragraphs (b) through (f)

as paragraphs (a) through (e),

respectively.

PART 308—SANITATION

4. The authority citation for Part 308

would be revised to read as follows:

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

2.53.

§ 308.2 [Removed]

5. Section 308.2 would be removed

and reserved.

6. Section 308.5 would be amended

by removing ‘‘, in the judgment of the

Administrator,’’ from the first and third

sentences of paragraph (a); removing

paragraphs (b) through (f); redesignating

paragraph (g) as (b); and revising the

section heading to read as follows:

§ 308.5 Equipment and utensils to be

easily cleaned; those for inedible products

to be so marked; PCB-containing

equipment.

* * * * *

PART 317—LABELING, MARKING

DEVICES, AND CONTAINERS

7. The authority citation for part 317

would continue to read as follows:

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

2.53.

8. Section 317.21 would be amended

by removing the words ‘‘or Partial

Quality Control Program’’ from

paragraph (b).

PART 318—ENTRY INTO OFFICIAL

ESTABLISHMENTS; REINSPECTION

AND PREPARATION OF PRODUCTS

9. The authority citation for part 318

would be revised to read as follows:

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

21 U.S.C. 601–695; 7 CFR 2.18, 2.53.

10. Paragraph (d) of § 318.4 would be

revised to read as follows:

§ 318.4 Preparation of products to be

officially supervised; responsibilities of

official establishments; plant operated

quality control.

* * * * *

(d) Partial Quality Control Programs.

(1) Any owner or operator of an official

establishment preparing meat food

products who is using a quality control

program for a product, operation, or part

of an operation shall make the written

program and data and information

generated by the program available to

Program employees.

(2) (i) Such quality control program

shall include, as appropriate for the

product, operation, or part of an

operation which the program concerns,

detailed information on: raw material

control, the critical check or control

points, the nature and frequency of tests

to be made, the charts and records that

will be used, the length of time such

charts and records will be maintained in

the custody of the official establishment,

the limits which will be used and the

points at which corrective action will be

taken to prevent recurrence of a loss of

control, and the nature of the corrective

action—ranging from the least to the

most severe.

(ii) Such quality control program shall

be designed so as to provide, with at

least 85 percent statistical confidence,

that the lot mean (process mean) is

within the product or label limit used

and that, of a minimum of 3 sublot

samples representing the lot, with each

sublot sample containing at least 5

samples representing the sublot, no
Federal Register / Vol. 61, No. 86 / Thursday, May 2, 1996 / Proposed Rules 19589

individual sample mean or sublotsample mean shall be greater than three

standard errors above, nor less than

three standard errors below, the process

mean.

* * * * *

11. Paragraph (e) of § 318.4 would be

amended by removing the words ‘‘or

Partial Quality Control’’ from the

paragraph heading, the words ‘‘or (d)’’

from the first sentence of paragraph

(e)(1) and both occurrences of the words

‘‘or partial quality control program’’

from the second sentence of the same

paragraph (e)(1); by removing the words

‘‘or program’’ from the first and second

sentences of paragraph (e)(2); by

removing the words ‘‘or partial quality

control program’’ from paragraph (e)(3);

and by revising the heading of

paragraph (g) and removing the words

‘‘or partial quality control program’’

from paragraphs (g)(1) and the

introductory text of (g)(2) and revising

paragraph (g)(3) to read as follows:

§ 318.4 Preparation of products to be

officially supervised; responsibilities of

official establishments; establishment

operated quality control.

* * * * *

(g) Termination of Total

Establishment Quality Control.

* * * * *

(3) If approval of the total

establishment quality control system

has been terminated in accordance with

the provisions of this section, an

application and request for approval of

the same or a modified total

establishment quality control system

will not be evaluated by the

Administrator for at least 6 months from

the termination date.

* * * * *

12. Paragraphs (b)(3)(i) and (b)(3)(ii) of

§ 318.7 would be revised to 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) such as to result in

compliance with this provision, or

(ii) A predetermined level between 40

and 80 ppm (potassium nitrite at a level

between 49 and 99 ppm); 550 ppm

sodium ascorbate or sodium erythorbate

(isoascorbate); and additional sucrose or

other similar fermentable carbohydrate

at a minimum of 0.7 percent and an

inoculum of lactic acid producing

bacteria such as Pediococcus acetolactii

or other bacteria demonstrated to be

equally effective in preventing the

growth of botulinum toxin at a level

sufficient for the purpose of preventing

the growth of botulinum toxin; provided

that the establishment has a partial

quality control program as provided in

§ 318.4(d) such as to result in

compliance with this provision.

* * * * *

13. 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’’

would be revised to read as follows:

§ 318.7 Approval of substances for use in

the preparation of products.

* * * * *

(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).

* * * * * * *

14. Section 318.19 would be amended

by removing the words ‘‘or partial

quality control program’’ from

paragraph (e).

15. Paragraph (a) of § 318.309 would

be amended by removing the words ‘‘an

approved’’ and ‘‘program’’ and

paragraphs (b) and (c) of § 318.309

would be amended by removing ‘‘and

submitted to the Administrator for

approval’’.

PART 319—DEFINITIONS AND

STANDARDS OF IDENTITY OR

COMPOSITION

16. The authority citation for Part 319

would continue to read as follows:

Authority: 7 U.S.C. 450, 1901–1906; 21

U.S.C. 601–695; 7 CFR 2.18, 2.53.

17. Section 319.5 would be amended

by removing the second sentence of

paragraph (e)(2) and revising the first

sentence to read as follows:

§ 319.5 Mechanically Separated (Species).

* * * * *

(e) * * *

(2) A prerequisite for label approval

for products consisting of or containing

‘‘Mechanically Separated (Species)’’ is

that such ‘‘Mechanically Separated

(Species)’’ shall have been produced by

an establishment under a establishment

quality control system. * * *

18. The last sentence in footnote 3 to

the chart in § 319.104 would be

amended by removing the words

‘‘approved by the Administrator under

§ 318.4 of this subchapter.’’

PART 381—POULTRY PRODUCTS

INSPECTION REGULATIONS

19. The authority citation for Part 381

would be revised to read as follows:

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

451–470; 7 CFR 2.18, 2.53.

20. Section 381.19 would be revised

to read as follows:

§ 381.19 Application for inspection;

irradiation facilities.

All applicants for inspection whose

operations include irradiation and other

processing would submit, to the

Administrator, a proposed quality

control system as specified in § 381.149.

§ 381.20 [Amended]

21. Section 381.20 would be amended

by removing ‘‘the approved drawings,
19590 Federal Register / Vol. 61, No. 86 / Thursday, May 2, 1996 / Proposed Rules

specifications, and’’ from the first

sentence.

22. Section 381.53 would be amended

by removing paragraph (b);

redesignating paragraphs (c) through (m)

as paragraphs (b) through (l),

respectively; and revising paragraph (a)

to read as follows:

§ 381.53 Equipment and utensils.

(a) Equipment and utensils used for

processing or otherwise handling any

edible poultry product or ingredient

thereof, in any official establishment,

shall comply with any applicable

provisions of paragraphs (b) through (l)

of this section and otherwise shall be of

such material and construction as will

facilitate their thorough cleaning, insure

cleanliness in the preparation and

handling of all edible poultry products,

and avoid adulteration and misbranding

of such products. In addition to these

requirements, equipment and utensils

shall not in any way interfere with or

impede inspection procedures.

Receptacles used for handling inedible

products shall be of such material and

construction that their use will not

result in adulteration of any edible

product or in unsanitary conditions at

the establishment, and they shall bear

conspicuous and distinctive marking to

identify them as only for such use and

shall not be used for handling any

edible poultry products.

* * * * *

§ 381.121d [Amended]

23. Section 381.121d would be

amended by removing the words ‘‘or

Partial Quality Control Program’’ from

paragraph (b).

24. The section heading and

paragraph (d) of § 381.145 would be

revised to 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 meat food

products who is using a quality control

program for a product, operation, or part

of an operation shall make the written

program and data and information

generated by the program available to

Program employees.

(2) (i) Such quality control program

shall include, as appropriate for the

product, operation, or part of an

operation which the program concerns,

detailed information on: raw material

control, the critical check or control

points, the nature and frequency of tests

to be made, the charts and records that

will be used, the length of time such

charts and records will be maintained in

the custody of the official establishment,

the limits which will be used and the

points at which corrective action will be

taken to prevent recurrence of a loss of

control, and the nature of the corrective

action—ranging from the least to the

most severe.

(ii) Such quality control program shall

be designed so as to provide, with at

least 85 percent statistical confidence,

that the lot mean (process mean) is

within the product or label limit used

and that, of a minimum of 3 sublot

samples representing the lot, with each

sublot sample containing at least 5

samples representing the sublot, no

individual sample mean or sublotsample mean shall be greater than three

standard errors above, nor less than

three standard errors below, the process

mean.

* * * * *

25. Paragraph (e) of § 381.145 would

be amended by removing the words

‘‘Programs or’’ from the paragraph

heading, the words ‘‘or (d)’’ from the

first sentence of paragraph (e)(1) and

both occurrences of ‘‘, partial quality

control program,’’ from the second

sentence of the same paragraph (e)(1);

by removing the words ‘‘or program’’

from the first and second sentences of

paragraph (e)(2); by removing ‘‘, partial

quality control program,’’ from

paragraph (e)(3); by revising the heading

of paragraph (g) and removing the words

‘‘or a partial quality control program’’

from paragraph (g)(1); by removing ‘‘,

partial quality control program,’’ from

paragraph (g)(2) introductory text and

the words ‘‘or program’’ from the first

sentence of paragraph (g)(2)(ii); and by

revising paragraph (g)(3) to read as

follows:

§ 381.145 Preparation of products to be

officially supervised; responsibilities of

official establishments; establishment

operated quality control.

* * * * *

(g) Termination of Total

Establishment Quality Control.

* * * * *

(3) If approval of the total

establishment quality control system

has been terminated in accordance with

the provisions of this section, an

application and request for approval of

the same or a modified total

establishment quality control system

will not be evaluated by the

Administrator for at least 6 months from

the termination date.

* * * * *

§ 381.309 [Amended]

26. Paragraph (a) of § 381.309 would

be amended by removing the words ‘‘an

approved’’ and ‘‘program’’ and

paragraphs (b) and (c) of § 381.309

would be amended by removing ‘‘and

submitted to the Administrator for

approval’’.

Done, at Washington, DC April 25, 1996.

Michael R. Taylor,

Acting Under Secretary for Food Safety.

[FR Doc. 96–10795 Filed 5–1–96; 8:45 am]

BILLING CODE 3410–DM–P

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Airspace Docket No. 96–AGL–5]

Establishment of Class E Airspace;

Sturgis, SD

AGENCY: Federal Aviation

Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking.

SUMMARY: This notice proposes to

establish Class E airspace at Sturgis, SD.

A Global Positioning System (GPS)

standard instrument approach

procedure (SIAP) to Runway 29 has

been developed for the Sturgis

Municipal Airport. Controlled airspace

extending upward from 700 feet above

ground level (AGL) is needed for aircraft

executing the approach.

DATES: Comments must be received on

or before June 6, 1996.

ADDRESSES: Send comments on the

proposal in triplicate to: Federal

Aviation Administration, Office of the

Assistant Chief Counsel, AGL–7, Rules

Docket No. 96–AGL–5, 2300 East Devon

Avenue, Des Plaines, Illinois 60018.

The official docket may be examined

in the Office of the Assistant Chief

Counsel, Federal Aviation

Administration, 2300 East Devon

Avenue, Des Plaines, Illinois. An

informal docket may also be examined

during normal business hours at the Air

Traffic Division, Operations Branch,

Federal Aviation Administration, 2300

East Devon Avenue, Des Plaines,

Illinois.

FOR FURTHER INFORMATION CONTACT:

John A. Clayborn, Air Traffic Division,

Operations Branch, AGL–530, Federal

Aviation Administration, 2300 East

Devon Avenue, Des Plaines, Illinois

60018, telephone (847) 294–7459.