Federal Register / Vol. 62, No. 164 / Monday, August 25, 1997 / Proposed Rules 45045

DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Parts 303, 308, 381, and 416

[Docket No. 96–037P]

Sanitation Requirements for Official

Meat and Poultry Establishments

AGENCY: Food Safety and Inspection

Service.

ACTION: Proposed rule.

SUMMARY: The Food Safety and

Inspection Service (FSIS) is proposing

to revise its regulatory requirements

concerning sanitation in official meat

and poultry establishments.

Specifically, FSIS is proposing to

consolidate the sanitation regulations

into a single part applicable to both

meat and poultry establishments,

eliminate unnecessary differences

between the meat and poultry sanitation

requirements, and convert many of the

highly prescriptive requirements to

performance standards.

DATES: Comments must be received on

or before October 24, 1997.

ADDRESSES: Submit one original and

two copies of written comments to FSIS

Docket Clerk, Docket #96–037P, U.S.

Department of Agriculture, Food Safety

and Inspection Service, Room 102,

Cotton Annex, 300 12th St. SW,

Washington, DC 20250–3700. All

comments submitted in response to this

proposal will be available for public

inspection in the Docket Clerk’s Office

between 8:30 a.m. and 4:30 p.m.,

Monday through Friday.

FOR FURTHER INFORMATION CONTACT:

Patricia F. Stolfa, Assistant Deputy

Administrator, Regulations and

Inspection Methods, Food Safety and

Inspection Service, U.S. Department of

Agriculture, (202) 205–0699.

SUPPLEMENTARY INFORMATION:

Background

On December 29, 1995, FSIS

announced that it had begun a

comprehensive review of its regulatory

procedures and requirements to

determine which were still needed and

which ought to be modified,

streamlined, or eliminated (FSIS Docket

No. 95–008A, ‘‘FSIS Agenda for Change:

Regulatory Review’’; 60 FR 67469–

67474). This ongoing review is an

integral part of the FSIS initiative to

improve the safety of meat and poultry

products by modernizing the Agency’s

system of food safety regulation.

Further, this review and the resulting

regulatory revisions reflect the Agency’s

commitment to achieving the goals of

the President’s Reinvention of

Government initiative: to have fewer,

clearer, and more user-friendly

regulations.

In the course of its review, FSIS

identified the need to revise its

sanitation requirements for official meat

and poultry establishments. A number

of the existing sanitation requirements

are difficult to understand, redundant,

or outdated. Also, there are unnecessary

differences between the sanitation

requirements for meat and poultry

establishments. Further, some of the

existing sanitation requirements are no

longer needed in light of the Agency’s

recently finalized Hazard Analysis and

Critical Control Point (HACCP) and

Sanitation Standard Operating

Procedure (SOP) requirements. Finally,

some of the current sanitation

regulations are unnecessarily

prescriptive, may impede innovation,

and blur the distinction between

establishment and inspector

responsibilities for maintaining sanitary

conditions.

Therefore, FSIS is proposing in this

document to revise its sanitation

regulations. FSIS is proposing to clarify

and consolidate the sanitation

requirements for meat and poultry

establishments, eliminate unnecessary

differences between those regulations,

make the existing sanitation regulations

more compatible with the HACCP and

sanitation SOP requirements, and

convert prescriptive requirements to

performance standards.

Sanitation

Proper and effective sanitation

practices and conditions are an essential

part of all safe food manufacturing

processes. Insanitary facilities and

equipment and poor food handling and

personal hygiene practices by

employees create an environment in

which pathogens and other food safety

hazards can contaminate and adulterate

products. Consequently, proper

sanitation is a fundamental requirement

under both the Federal Meat Inspection

Act (FMIA) and the Poultry Products

Inspection Act (PPIA).

The FMIA and the PPIA authorize the

Secretary of Agriculture to promulgate

regulations regarding sanitary practices

in official establishments. Meat and

poultry product produced, packed, or

held under insanitary conditions, where

they may have become contaminated

with filth or may have been rendered

injurious to health, are deemed

adulterated. Furthermore, if meat and

poultry products consist in whole or in

part of any filthy, putrid, or

decomposed substance, or for any other

reason are unsound, unhealthy,

unwholesome, or otherwise unfit for

human food, they are deemed to be

adulterated.

While sanitation has improved greatly

throughout the meat and poultry

industries over the years, many

individual establishments still have

difficulty maintaining the required

sanitary conditions. In fact, poor

sanitation is the most frequently

observed problem in meat and poultry

establishments. Between September

1993 and February 1995, the Food

Safety and Inspection Service (FSIS)

conducted unannounced reviews of

1,014 federally inspected meat and

poultry establishments, observing

operations and noting deficiencies.

More than 60 percent of all deficiencies

documented by these reviews involved

establishment sanitation. Data collected

through FSIS’s Performance Based

Inspection System similarly documents

that sanitation is the most frequent

deficiency noted by inspection

personnel in routine establishment

visits.

FSIS inspectors examine the

conditions under which meat and

poultry products are produced at official

establishments. Until the recent

implementation of Sanitation Standard

Operating Procedure (SOP’s)

requirements, FSIS enforced sanitation

requirements primarily through a

combination of prescriptive sanitation

regulations, detailed guidance materials,

and direct, hands-on involvement by

inspectors in day-to-day pre-operational

and operational sanitation procedures in

establishments. This system achieved

sanitation goals on a daily basis in

individual establishments, but

encouraged establishments to shift

accountability for sanitation to the FSIS

inspector.

To make establishments appropriately

accountable for food safety, including

the maintenance of sanitary conditions,

the Agency recently finalized major

changes to the meat and poultry

regulations (FSIS Docket No. 93–016F,

‘‘Pathogen Reduction; Hazard Analysis

and Critical Control Point (HACCP)

Systems’’; 61 FR 38806). Under these

new regulations, every official meat and

poultry establishment will be required

to develop and implement HACCP, a

science-based process control system

designed to improve the safety of meat

and poultry products. Establishments

will be responsible for developing and

implementing HACCP plans

incorporating the controls necessary and

appropriate to produce safe meat and

poultry products. At the same time,

HACCP is a flexible system that enables

establishments to tailor their control
45046 Federal Register / Vol. 62, No. 164 / Monday, August 25, 1997 / Proposed Rules

systems to the individual needs of their

particular plants and processes.

FSIS also has required all official

establishments to develop, implement,

and maintain written Sanitation

Standard Operating Procedures (SOP’s).

Sanitation SOP’s must describe all

procedures an official establishment

conducts daily, before and during

operations, to prevent direct

contamination or adulteration of

product(s). The format and content of

Sanitation SOP’s are not specified in the

final regulations; so, as under HACCP,

each meat and poultry establishment

must analyze its own operations and

identify possible sources of direct

contamination or adulteration that need

to be addressed in its Sanitation SOP’s.

Effective establishment sanitation

through the development and

implementation of written Sanitation

SOP’s is essential to improve food safety

and for the successful implementation

of HACCP. Establishment compliance

with the Sanitation SOP requirements

will not only substantially minimize the

risk of direct product contamination or

adulteration, but also will improve the

utilization of FSIS inspection resources

by refocusing sanitation inspection on

the oversight of establishment

prevention and correction of conditions

that cause direct product contamination

or adulteration.

Performance Standards

For the HACCP and SOP requirements

to be successful, FSIS believes it must

reduce its reliance on detailed,

command-and-control regulations.

Command-and-control regulations

prescribe step-by-step procedures

establishments must use toward the goal

of safe meat and poultry products. Such

regulations can be incompatible with

HACCP and the SOP requirements to

the extent that they deprive

establishments of the flexibility to

innovate and deter them from assuming

their full share of responsibility for food

safety.

FSIS is engaged in a thorough review

of its current regulations and, where

possible, will eliminate overly

prescriptive regulations and replace

them with regulations that embody

performance standards. Such

regulations establish requirements in

terms of the objective to be achieved.

They specify the ends, but do not detail

the means to achieve those ends.

Adopting performance standards for

meat and poultry products would allow

establishments to develop and employ

innovative and more effective sanitation

or processing procedures customized to

the nature and volume of their

production.

FSIS also believes that the existing

sanitation regulations may interfere

with efforts to implement the Sanitation

SOP requirements of the final Pathogen

Reduction/HACCP regulation.

Commenters on the proposed HACCP

rule expressed their concerns about the

layering of new Sanitation-SOP

requirements over existing regulations.

These concerns have merit. The Agency

indicated in the Preamble to the Final

Pathogen Reduction/HACCP regulation

that ‘‘its existing sanitation regulations

contain some detailed and prescriptive

provisions and that some of these

regulations may be outmoded and no

longer needed in light of the Agency’s

effort to clarify that good sanitation is

the responsibility of each

establishment.’’ The Agency also stated

that it ‘‘* * * will continue to review,

re-evaluate, and revise, as necessary , all

current sanitation regulations, along

with related issuances and sanitation

inspection procedures, to simplify and

streamline them and make them more

compatible with Sanitation SOP

requirements.’’ In addition, at recent

implementation conferences held in

Washington and at six cities across the

country, participants raised questions

about the relationship between existing

requirements and the new Sanitation

SOP’s.

Accordingly, FSIS is proposing to

convert all of its sanitation requirements

to performance standards. The proposed

performance standards regarding the

general sanitary conditions of an

establishment would provide meat and

poultry establishments with the

maximum possible flexibility to

innovate in facility design, construction,

and operations, and allow them to tailor

Sanitation SOP’s to their particular

circumstances. Furthermore, many of

the current sanitation regulations

requiring that equipment or operations

be approved prior to use (such as trap

and vent approval requirements in

§§ 308.3(c) and 381.49(c)(1)) would be

eliminated.

Explanation of the Proposed Sanitation

Performance Standards

FSIS is proposing to replace all of the

current sanitation regulations in 9 CFR

Parts 308 and 381, Subpart H, with a

single set of consolidated performance

standards in new Sections 416.1

through 416.6. This is a comprehensive

revision; the relationship between the

current requirements and the proposed

performance standards is complex.

Therefore, FSIS has developed the

following chart to illustrate how current

sanitation requirements correspond to

the proposed performance-based

regulations. A description of the

requirements(s), along with regulatory

citations for the current and proposed

regulations are given. Notably, FSIS is

proposing to eliminate many of the

current prescriptive sanitation

requirements and replace them with a

single performance standard for general

sanitation. Following the chart is a more

detailed explanation of the proposed

revisions.

Subject Proposed regulation Current regulation(s)

General sanitation ................................................................. § 416.1 ....................... §§ 308.3(a), (g), 308.7, 381.45, 381.57; and all other provisions not listed below.

Establishment grounds and pest management ................... § 416.2(a) .................. §§ 308.3 (h), 308.13, 381.49(b), 381.56(a), 381.59, and

381.60.

Establishment Construction .................................................. § 416.2(b) .................. §§ 308.3(e), (f), (h), 381.46, 381.47 and 381.48.

Light ...................................................................................... § 416.2(c) ................... §§ 308.3(b), 381.52 (a) and (b).

Ventilation ............................................................................. § 416.2(d) .................. §§ 308.3 (b) and (g), 308.8(b), 381.52 (a) and (c).

Plumbing ............................................................................... § 416.2(e) .................. §§ 308.3(c), 381.47(b), 381.49 (a), (b) and (c).

Sewage disposal ................................................................... § 416.2(f) ................... §§ 308.4(c) and 381.49(c)(4).

Water supply and reuse ....................................................... § 416.2(g) .................. §§ 308.3(d), 381.50 and 381.53(k).

Ice and solution reuse .......................................................... § 416.2(h) .................. FSIS policy (explained below).

Dressing rooms, lavatories, and toilets ................................ § 416.2(i) .................... §§ 308.4 (a), (b), (d), 381.47(h), 381.51 and 381.53(c).

Equipment and utensils ........................................................ § 416.3 ....................... §§ 308.5 (a) and (g), 308.6, 308.8(c), 308.16, 381.53(a)(1),

(f), (g), (h), (i), (j), (k), (l), (m), 381.54, 381.55 and

381.56(b).

Food-contact surface cleaning and sanitation ...................... § 416.4(a) .................. §§ 308.3(d)(4), 308.7, 308.8(a), 381.57 and 381.58.

Non-food-contact surface cleaning and sanitation ............... § 416.4(b) .................. §§ 308.3(d)(4), 308.7, 308.8(a), 381.57 and 381.58.

Cleaning compounds and sanitizers .................................... § 416.4(c) ................... § 381.60.
Federal Register / Vol. 62, No. 164 / Monday, August 25, 1997 / Proposed Rules 45047

Subject Proposed regulation Current regulation(s)

Operational sanitation ........................................................... § 416.4(d) .................. §§ 308.3(g), 308.7, 308.8(a), 308.9, 308.10, 308.11,

308.12, 381.47(e), 381.53(d),(e), and (g)(4).

Employee hygiene ................................................................ § 416.5(a) .................. §§ 308.8(c),(e), 381.47(i), 381.51(g), 381.61(b),(c), and (d).

Employee clothing ................................................................ § 416.5(b) .................. §§ 308.8(d) and 381.61(b).

Employee disease ................................................................ § 416.5(c) ................... §§ 308.14 and 381.61(a).

Tagging insanitary equipment, rooms, or compartments ..... § 416.6 ....................... §§ 308.15 and 381.99.

The Proposed Regulations

This proposed rule would

significantly reduce the number of

sanitation regulations and consolidate

the sanitation requirements for meat and

poultry into part 416. This

consolidation would not only simplify

the sanitation regulations for the user,

but also would establish uniform

sanitation performance standards that

would provide flexibility to

establishments while maintaining the

rigorous sanitation standards necessary

to ensure food safety. The

establishment’s responsibility for

maintaining sanitary conditions and

preventing the contamination and

adulteration of product would remain

unchanged. Further, in consolidating

the sanitation regulations, FSIS would

eliminate the unnecessary differences

between the current sanitation

requirements for meat and poultry

establishments. In the following, FSIS

has provided brief descriptions of the

proposed sanitation performance

standards accompanied by examples of

current regulations they would replace.

General Sanitation—416.1

The current sanitation regulations for

meat and poultry require in general that

rooms, compartments, and other parts of

the official establishment be kept clean

and sanitary. New § 416.1 sets out

similar requirements, but as a

performance standard: ‘‘Each official

establishment must be operated and

maintained in sanitary manner

sufficient to ensure that product is not

contaminated, adulterated, or

misbranded.’’ As discussed above and

illustrated by the chart, FSIS is

proposing to eliminate many of the

current sanitation requirements and

replace them with this single

performance standard for general

sanitation. Examples of current

requirements to be replaced by the

general standard are: §§ 308.3(i) and

381.59, concerning dogs, cats, and other

animals on establishment premises;

§ 308.8(f), concerning equipment that

generates gases or odors in meat

establishments; and § 381.47 paragraphs

(f) and (g), concerning general sanitary

conditions in poultry establishment

storage and boiler rooms.

Establishment Grounds and Pest

Management—§ 416.2(a)

The current requirements for facility

grounds are somewhat prescriptive and

inconsistent. For example, § 308.13

requires that outer premises of every

official meat establishment be properly

paved and drained and kept in clean

and orderly condition. However, the

counterpart regulation in § 381.56(a)

concerning the outside premises of

poultry establishments does not require

grounds to be paved. The proposed

performance standard would eliminate

this inconsistency while clarifying and

retaining the intent of the current

requirements: that grounds be

maintained to prevent conditions that

could lead to the contamination or

adulteration of product or prevent FSIS

program employees from performing

assigned tasks.

The current requirements for pest

control on establishment grounds and

within establishments place much of the

responsibility for pest control on the

Agency. For example, §§ 308.3(h)

prohibits the use of poisons for the

control of pests in rooms or

compartments where unpackaged

product is stored or handled, unless

approved in the regulations or by the

circuit supervisor. Similarly, the

regulations in § 381.60 prohibit the use

of pest control substances in poultry

establishments unless approved by the

Administrator.

The proposed performance standard

preserves the intent of the current

requirement: establishments must

implement and maintain an integrated

pest control program to eliminate the

harborage and breeding of pests on the

grounds and within the establishment

facilities and must safely and effectively

use any interventions, such as

pesticides, fumigants, and rodenticides.

The proposed standard would eliminate

requirements that pest control

substances be approved by FSIS prior to

use.

Finally, current § 308.3(h) specifically

prohibits the use of ‘‘so-called rat

viruses’’ in meat establishments. FSIS

has determined that this prohibition is

obsolete and therefore is proposing to

delete it.

Establishment Construction—416.2(b)

The requirements concerning

construction of poultry establishments

are more prescriptive than the

comparable requirements for red meat

establishments. For example, § 381.47

prescribes numerous, specific

requirements for the different areas

within a poultry establishment, e.g.,

refuse rooms, rooms for holding

carcasses for further inspection, coolers

and freezers, rooms for mechanical

deboning of raw poultry, storage and

supply rooms, boiler rooms, toilet

rooms, and lunch rooms. There are no

equally prescriptive requirements in

§ 308.3 (e), (f), and (h) of the red meat

regulations. The proposed performance

standards in § 416.2(b), which set forth

general requirements for construction

applicable to both meat and poultry

establishments, would eliminate the

existing inconsistency.

The proposed performance standards

allow for increased flexibility in regard

to establishment construction and

maintenance. FSIS recommends that

establishments consult the Food and

Drug Administration Food Code when

designing, building, or maintaining

facilities. The Food Code provides

useful guidance on how to safely

process and prepare food. Although the

Food Code is neither federal law nor

federal regulation and does not preempt

state or local laws, local, state and

federal regulators use the FDA Food

Code as a model to help develop or

update their own food safety rules and

to guide the development of a consistent

national food regulatory policy.

Similarly, establishment operators also

should consult the various national

building and construction codes and

standards. Such materials provide

additional guidance concerning the

design, construction, and maintenance

of sanitary meat and poultry

establishments.

Also, in a related document published

in the Federal Register on May 2, 1996,

FSIS proposed to eliminate current
45048 Federal Register / Vol. 62, No. 164 / Monday, August 25, 1997 / Proposed Rules

requirements for prior approval by FSIS

of establishment drawings,

specifications, and equipment prior to

their use in official establishments (FSIS

Docket No. 95–032P; 61 FR 19587–

19590). These amendments, like the

proposed sanitation performance

standards, would provide the regulated

industry with the flexibility to design

facilities and equipment in the manner

they deem best to maintain the required

sanitary environment for food

production.

Light—416.2(c)

Currently, the lighting requirements

for poultry establishments in § 381.52

prescribe specific light intensities for

different areas of the establishment. For

example, in paragraph (b) of this

section, FSIS requires that all rooms in

which poultry is killed, eviscerated, or

otherwise processed have 30-foot

candles of light intensity on all working

surfaces. The comparable regulations for

red meat establishments in § 308.3(b) do

not contain such specific requirements,

stating only that meat establishments

must have ‘‘abundant light, of good

quality and well distributed.’’

Nevertheless, the intent of the current

lighting requirements is the same for

both meat and poultry establishments:

there must be enough light of adequate

quality to monitor sanitary conditions

and processing operations and to

examine product for evidence of

contamination, adulteration, or

misbranding. Proposed § 416.2(c) would

codify this intent as a single

performance standard applicable to both

meat and poultry establishments.

FSIS suggests that establishments

consult the guidelines for light intensity

contained in the Food Code. The Food

Code provides useful guidance

regarding necessary light intensity in

food processing establishments and, in

many cases, an establishment in

compliance with the light intensity

recommendations in the Food Code

would meet the proposed performance

standard for lighting.

It is important to note that FSIS is not

proposing to remove from the current

regulations the light intensity

requirements for inspector and

reprocessing stations currently set out in

§§ 307.2 and 381.36. Our experience

indicates that these requirements are

still necessary to ensure appropriate

conditions for effective inspection. FSIS

will reevaluate these requirements,

however, and welcomes comment on

the current requirements and desirable

alternatives.

Ventilation—416.2(d)

Currently both the red meat and

poultry regulations addressing

ventilation have the same basic

requirements: all rooms must be

sufficiently ventilated to eliminate

objectionable odors and minimize

moisture condensation, either of which

could contaminate or adulterate

product. FSIS is proposing a single

performance standard based upon these

current requirements and applicable to

both meat and poultry establishments.

Plumbing—416.2(e)

The design, installation and

maintenance of an adequate plumbing

system is a key responsibility of the

establishment. Because plumbing

systems carry water into establishments

and convey water, sewage, and other

waste from establishments, problems

with plumbing systems can easily cause

product contamination or adulteration.

The proposed performance standards

would establish the essential condition

meat and poultry establishments must

achieve with their plumbing systems:

plumbing systems cannot cause

contamination or adulteration of

product. Establishments otherwise

would be allowed to build plumbing

systems suitable to the nature and

volume of their production. Further,

prior approval requirements in the

current plumbing regulations (such as

the requirement in § 308.3(c) that circuit

supervisors must preapprove the traps

and vents installed in drains and

gutters) would be eliminated.

FSIS suggests that establishments

consult the National Plumbing Code

published by the Building Officials &

Code Administrators when designing or

building a plumbing system. The

National Plumbing Code is used by

Federal, State, and local governments as

a model for their own plumbing

requirements. A plumbing system in

compliance with the National Plumbing

Code in most instances would meet the

proposed performance standards for

plumbing. Of course, establishments

also should consider State and local

plumbing system requirements, as well

as the circumstances of their

production, when designing or building

a plumbing system.

Sewage Disposal—416.2(f)

The current requirements for

establishment sewage disposal are

unnecessarily prescriptive. For example,

§ 308.4(c) of the regulations requires

sewage lines to be separate from all

other drainage lines to a point outside

the building and not be discharged into

grease catch basins; § 381.49(c)(4) is

similar, but allows for cross-connection

if an automatic backwater check valve is

installed. The intent of these

requirements is to ensure that sewage

does not back up into processing areas.

However, this could be accomplished in

other ways than through separate

drainage lines for sewage and house

drains. The proposed performance

standard would maintain the

requirement that sewage backup be

prevented, but would allow the

establishment flexibility in determining

how best to prevent sewage backup.

As with plumbing, FSIS believes that

the National Plumbing Code contains

useful guidance for designing and

building sewage systems that would

satisfy the proposed regulatory

requirements.

Water supply and reuse—416.2(g)

The current requirements regarding

water supply and reuse in meat and

poultry establishments (§§ 308.3(d),

381.50 and 381.53(k)) are similar,

though not identical. In general, both

meat and poultry establishments are

required to have water supplies that are

‘‘ample, clean, and potable, with

adequate facilities for its distribution

* * * and protection against

contamination and pollution.’’ Neither

meat nor poultry establishments may

use nonpotable water in areas where

edible product is processed or handled

and the use of nonpotable water is

limited to specific areas and equipment.

Further, in both meat and poultry

establishments, potable water lines may

not be cross-connected with nonpotable

water lines, unless necessary for fire

protection and approved by both FSIS

and local authorities.

Restrictions on the reuse of water also

are similar for both meat and poultry

establishments. A few permitted

‘‘reuses’’ are specified, one in common

for both meat and poultry being the

reuse of water to thermally process

canned product packed in hermetically

sealed containers. Any other water reuse

must be for the identical original

purpose and must be approved by FSIS.

Finally, both the meat and poultry

regulations require that an adequate

supply of hot water be available for

cleaning rooms and equipment.

There are a few differences between

the water supply and reuse regulations

for meat and poultry establishments.

Under § 308.3(d)(4), meat

establishments are required to have an

ample supply of water of at least 180°

F for cleaning equipment, floors, and

walls subject to contamination by

diseased meat carcasses. There is no

similar requirement for poultry

establishments. Because there are
Federal Register / Vol. 62, No. 164 / Monday, August 25, 1997 / Proposed Rules 45049

substantive and material questions

about the efficacy of the 180° F water for

sanitization, the Agency is proposing to

eliminate the requirement (see the

discussion below under ‘‘Equipment

and Utensils—416.3’’).

Also, under § 381.50(d), FSIS

specifically requires that poultry

establishment refuse rooms ‘‘be

provided with adequate facilities for

washing refuse cans and other

equipment in the rooms.’’ There is no

such specific requirement for meat

establishments. Finally, under

§ 381.50(a), FSIS requires that poultry

establishments obtain a water report

issued under the authority of a State

health agency, certifying potability, and

furnish this report to FSIS upon request.

Although there is no such regulatory

requirement for meat establishments,

FSIS believes that all meat

establishments do obtain such

certificates.

Proposed § 416.2(g) consolidates

water supply and reuse requirements for

both meat and poultry into a single

section. The proposed performance

standards are based on the current

regulations, as well as policies found in

FSIS policy documents. Also

incorporated are water reuse

performance standards generated over

time by industry and known to be

effective in ensuring that the reuse

water does not cause product

contamination or adulteration.

Proposed § 416.2(g), paragraph (1),

sets forth a water supply performance

standard based upon the general

requirements in the current regulations:

A supply of running water that complies

with the National Primary Drinking Water

regulations (40 CFR Part 141), at a suitable

temperature and under pressure as needed,

must be provided in all areas where required

(for processing product, for cleaning rooms

and equipment, utensils, and packaging

materials, for employee sanitary facilities,

etc.). A water report, issued under the

authority of the State health agency,

certifying or attesting to the quality of the

water supply, must be made available to the

Agency upon request.

Notably, the proposed standard makes

transparent a current requirement

concerning potable water: that it comply

with EPA National Primary Drinking

Water regulations. These regulations are

promulgated under Section 1412 of the

Public Health Service Act, as amended

by the Safe Drinking Water Act, and are

applicable to public water systems.

Because these regulations already apply

to potable water used by meat and

poultry establishments, the reference in

the proposed performance standards

would not constitute a new

requirement.

The proposed performance standard

also restates the current requirement

that establishments must make available

to FSIS, upon request, State certificates

attesting to water quality. The

performance standard clarifies that this

requirement applies to both meat and

poultry establishments. As explained

above, while currently there is no such

regulatory requirement for meat

establishments, it is likely that all meat

establishments obtain such certificates

and also that they would make them

available to FSIS. FSIS believes,

therefore, that this provision would not

impose a new requirement upon meat

establishments.

Proposed § 416.2, paragraphs (g) (2)

through (6) set forth performance

standards for the reuse of water in meat

and poultry establishments. As

explained above, the regulations

currently permit water to be reused only

under certain circumstances and require

that any other reuse be approved by the

Agency in advance. The proposed

performance standards are intended to

account for every allowable water reuse

situation and eliminate the need for

prior approval.

The meat and poultry industries need

great quantities of water for processing

products and for cleaning. Water and

water based (aqueous) solutions are

widely used for product formulation,

slaughter, cooking, cooling the

equipment, and chilling products as

well as for cleaning and sanitization.

Reuse of water and solutions, therefore,

can offer significant economic

advantages.

Historically, FSIS and other public

health agencies have required that only

potable water be used in the production

of meat and poultry products. However,

over the past 20 years the Agency has

recognized that reuse water, which does

not meet all of the EPA requirements for

potability, may be used safely and

effectively in certain processing

situations. In the early 1990’s EPA,

FDA, and FSIS representatives agreed

that current technology will allow for

the reconditioning of water for safe and

effective reuse in various applications.

Reuse water can be treated to render

it free of physical, microbiological, and

chemical hazards. Some of the general

treatment options used include:

filtration, chlorination, ozonation,

ultraviolet (UV) radiation, and heating.

Use of these procedures can usually

return water to a level of quality

appropriate to its intended use. After

treatment, however, such water should

be tested regularly to assure continual

freedom from biological, chemical, or

physical hazards.

Depending upon the original use, the

intended reuse, and the duration of

reuse, a wide range of acceptable

microbiological, chemical, or physical

contaminant levels are possible in reuse

water. The previous degree of exposure

or potential exposure to contaminants

dictates the appropriate reconditioning

treatment and the allowable reuse. FSIS

has based its proposed performance

standards for water reuse on these

factors.

Proposed § 416.2(g), paragraph (2)

states:

Water used to chill or cook ready-to-eat

product may be reused for the same purpose,

provided that measures are taken to ensure

that it is maintained free of pathogenic

organisms and fecal coliform organisms and

that other physical, chemical, and

microbiological contamination is reduced so

as to prevent contamination or adulteration

of product.

FSIS expects establishments to produce

ready-to-eat products that are free of

pathogens; therefore, FSIS is proposing

to require that reuse water used to chill

or cook ready-to-eat product be free of

pathogens. FSIS is proposing to require

that this reuse water be free of fecal

coliforms because their presence would

indicate that the water was

contaminated, possibly with pathogenic

organisms. Finally, FSIS is proposing

that other types of contamination be

reduced sufficiently to prevent

contamination or adulteration of

product.

Paragraph (4) of this proposed section

states:

Water used to chill or wash raw product

may be reused for the same purpose provided

that measures are taken to reduce physical,

chemical, and microbiological contamination

so as to prevent contamination or

adulteration of product. Reuse water which

has come into contact with raw product may

not be used on ready-to-eat product.

FSIS is proposing to require that

physical, chemical, and microbiological

contamination be reduced to minimize

the risk of cross-contamination in

general. FSIS also is proposing to

require that water used to chill or wash

raw product be reused only for the same

purpose to minimize the possibility of

cross-contamination between different

types of products or processes. Because

raw product often is initially

contaminated with pathogenic

microorganisms and fecal coliforms,

FSIS is not proposing to require that this

reuse water be free of those

contaminants. Finally, FSIS is

proposing to prohibit water which has

come into contact with raw product

from being used on ready-to-eat product

so as to prevent the cross-contamination

of ready-to-eat product by contaminants
45050 Federal Register / Vol. 62, No. 164 / Monday, August 25, 1997 / Proposed Rules

1Peel, B., and Simmons, G.C. (1976)

Contamination of Knives as a Means of Spread of

Salmonellae in Meatworks. Proceedings of the

Annual Conference of the Australian Veterinary

Association, 53: 38–39.

2Peel, B., and Simmons, G.C. (1978) Factors in

the Spread of Salmonellae in Meatworks with

or adulterants from raw product.

Current regulations mandating the

separation of raw and ready-to-eat

product serve the same purpose.

Proposed paragraph (4) applies to

meat or poultry establishments that

recondition their water through an

advanced wastewater treatment facility,

usually either onsite or under contract.

Such water meets the criteria prescribed

in National Primary Drinking Water

regulations (40 CFR part 141)

concerning water quality. It cannot be

considered ‘‘potable,’’ however, because

it would not originate from the best

available source. The best available

source would most often be a municipal

water system.

Because this reconditioned water is of

such high quality, FSIS is proposing to

allow it to be used ‘‘on raw product,

except in product formulation, and

throughout the facility in edible and

inedible production areas.’’ Notably, to

prevent establishments from using water

from sewage lines, FSIS would not

allow this water to ever have contained

human waste. Further, FSIS is

proposing to require that ‘‘product,

facilities, and equipment coming in

contact with this water must undergo a

separate final rinse with nonreconditioned water that meets the

criteria prescribed in paragraph (g)(1) of

this section.’’ This requirement, as well

as the prohibition against the use of this

water in product formulation, are

redundant safeguards, already accepted

by industry. They serve to further

prevent contamination or adulteration

of product. It is likely that

establishments would use the reuse

water described in this provision to

wash equipment, floors, and carcasses

on the kill floor, all of which can easily

be rinsed.

Proposed paragraph (5) of this section

permits any water to be used for any

purpose in edible or inedible product

areas, provided that it has never

contained human waste, has been

conditioned to be free of pathogenic

organisms, and does not contact edible

product. FSIS is proposing to require

that this reuse water never have

contained human waste to prevent

establishments from using water from

sewage lines. FSIS is proposing to

require this reuse water to be

reconditioned until free of pathogenic

organisms to prevent the spread of

pathogenic organisms throughout an

establishment, which could lead to

cross-contamination of product. Finally,

because this reuse water may contain

fecal coliforms or chemical or physical

contaminants, FSIS is proposing to

prohibit it from contacting edible

product.

Finally, proposed paragraph (6) states

that any water not meeting the

conditions of § 416.2(g) paragraphs (1)

through (5) may not be used, except in

areas where no edible product is

handled or prepared and may not be

used in any manner which would allow

it to contaminate or adulterate edible

product.

Ice and Solution Reuse—416.2(h)

Similarly, FSIS is proposing to codify

performance standards for ice and

solution reuse taken from Agency policy

statements (e.g. FSIS Directive 7110.4,

‘‘Liquid Smoke Re-Use’’ and ‘‘MPI

Bulletin 83–16, ‘‘Reuse of Water or

Brine Cooling Solutions on Product

Following a Heat Treatment’’) and

accepted industry practices known to

ensure that reused ice or solutions do

not contaminate or adulterate product.

The proposed standards for reuse of ice

or solutions in § 416.2(h) are similar to

those proposed for water reuse.

The performance standards proposed

for reuse of ice or solutions on ready-toeat product (§ 416.2(h)(3)) serve the

same purpose as those proposed for

water reuse on ready-to-eat product

(§ 416.2(g)(5)). The proposed

performance standards for reuse of ice

or solutions on raw or partially-cooked

product (§ 416.2(h)(4)) are slightly

different than those proposed for water

reuse on raw products (§ 416.2(g)(4)).

Unlike the corresponding requirements

for water reuse, ice or solutions from

any source may be reused to chill raw

or partially-cooked product. To

minimize the possibility of crosscontamination between different types

of products or processes, FSIS is

proposing that such ice be free of fecal

coliforms, which indicate

contamination.

Dressing Rooms, Lavatories, and

Toilets—416.2(i)

Certain current regulations

concerning dressing rooms, lavatories,

and toilets in poultry establishments are

highly prescriptive. For example,

§ 381.51(h) prescribes the exact number

of toilet bowls that should be installed

within an establishment based on the

number of people employed, the intent

being to ensure that establishments

provide an adequate number of toilet

bowls, thus maintaining related sanitary

conditions. The proposed performance

standards would give meat and poultry

establishments the responsibility and

flexibility to determine how many

dressing rooms, lavatories, and toilets it

needs. Of course, establishments would

have to meet any applicable State and

local codes concerning the number of

lavatories and toilets in the workplace.

Also, the current regulations for

dressing rooms, lavatories, and toilets

include requirements already present in

other sections of the sanitation

regulations. For example, ventilation is

addressed in §§ 308.3(b), 308.4(a), and

308.8(b). The proposed, unified

regulations eliminate such

redundancies.

Equipment and Utensils—416.3

The current regulations concerning

equipment and utensils are unduly

prescriptive and can deprive

establishments of the flexibility to

innovate in regard to equipment and

utensil sanitation. The proposed

performance standards not only provide

flexibility, but also clarify establishment

responsibility for selecting and

maintaining equipment and utensils in

a manner that effectively prevents

product contamination or adulteration:

Equipment and utensils used for

processing or otherwise handling edible

product or ingredients must be of such

material and construction to facilitate

thorough cleaning and ensure that product is

not contaminated, adulterated, or

misbranded during processing, handling, or

storage. Equipment and utensils must be

maintained in sanitary condition so as not to

contaminate or adulterate product.

FSIS also is proposing to eliminate

§ 308.8(c) of the regulations which

requires that all implements used in

dressing diseased meat carcasses be

cleaned either with hot water having a

minimum temperature of 180° F or a

disinfectant approved by the

Administrator and that they then be

rinsed in clean water. This requirement,

and the 180 °F water requirement

specified in § 308.3(d)(4), are intended

as sanitization steps, effecting a

reduction in microbial levels on areas

subject to contamination.

However, research has raised

questions about the efficacy of the 180

°F requirement. When there is organic

matter present on equipment, such as

that which would occur during

slaughter or processing operations at

meat or poultry establishments, the

length of time necessary to achieve

disinfection can be variable.

Additionally, sometimes disinfection

may not be achieved since hot water can

bake organic material onto a surface,

impeding the penetration of the water

and diminishing the efficacy of the hot

water disinfection.1, 2
Federal Register / Vol. 62, No. 164 / Monday, August 25, 1997 / Proposed Rules 45051

Special Reference to Contamination of Knives.

Australian Veterinary Journal 54: 106-110.

3Husband, P. And McPhail, N.G. (1978) The Use

of 82 °C Water in Meat Plant Cleaning Operations.

CSIRO Meat Research Report No. 2/78.

Commonwealth Scientific and Industrial Research

Association.

4 Ibid.

5Weise, E., and Levitzow , R. (1976) Is 82 Degree

C the Optimum Water Temperature for Cleaning

Slaughterhouses? Fleischwirtschaft 56(12): 1725–

1728.

Research also indicates that

maintaining the temperature of a water

spray from the nozzle to a surface is

quite different from immersion of

utensils in an 180 °F water bath.

Husband and McPhail 3 studied the

specific effects of the use of sprayed 180

°F water for cleaning boning rooms in

Australia. Initial measurements of water

temperature along a sprayed stream

indicated that water temperature

dropped rapidly with distance from the

nozzle. If the initial temperature at the

nozzle was 180 °F, the temperatures

recorded at 1, 2, and 3 meter points

along the water stream were 176 °F, 169

°F, and 163 °F respectively. A maximum

temperature of only 127 °F was obtained

at the boning table surface when water

at an initial nozzle temperature of 180

°F was sprayed at a distance of one

meter. Fogging, which results in

undesirable condensation, was

subjectively judged to be severe

whenever nozzle temperatures exceeded

149 °F in a boning room with an initial

ambient temperature of 50 °F.

Husband and McPhail 4 also claimed

that water at 120 °F nozzle temperature

was as effective as water at 180 °F

nozzle temperature in reducing bacterial

numbers on flat uncleaned and

unsanitized surfaces to low levels of 40–

75 cfu per 5 cm 2. These results were

applicable for bacteria originating from

meat smears or from dried-on

suspensions of broth cultures. However,

they concluded that rinse water at 131–

138 °F nozzle temperature is the most

suitable for all stages of an effective

cleaning and sanitization procedure.

This conclusion was reached in

consideration of the fact that residual fat

is effectively removed, fogging and its

resulting condensation is reduced, and

energy is conserved. The authors assert

that bacteriological reduction of at least

5 logs from flat stainless steel surfaces

was expected after effective cleaning

and sanitization, irrespective of rinse

water temperature.

Attempts to ‘‘disinfect’’ with chemical

agents or 180 °F water are of limited

value unless the surfaces are first

thoroughly cleaned of organic residue

such that the bacteria are not protected

by film. Weise and Levitzow 5

demonstrated that cleaning surfaces in

slaughterhouses with just 180 °F water

caused coagulation of protein. Protein

and fat remained on the examined

metal, plastic, and ceramic tile surfaces.

They recommended 165 °F water for 30

seconds to clean, but not disinfect, these

surfaces in slaughterhouses.

In the 1970’s, the need for energy

conservation created interest in the use

of chemical disinfectants in lieu of 180

°F water. While the Environmental

Protection Agency (EPA) registers

disinfectants under the Federal

Insecticide, Fungicide and Rodenticide

Act primarily for hospital use, there was

concern within FSIS about whether

such chemical disinfectants would

ensure adequate disinfection of surfaces

and equipment in meat and poultry

plants, where pathogens such as

tuberculosis may be present. FSIS

developed a program to enable

disinfectant manufacturers to apply for

approval of disinfectants and for meat

and poultry plants to apply for use of

approved compounds in lieu of 180 °F

water. The requirements were published

in MPI Bulletin 77–34 (3–16–77). At this

time, there are no disinfectants that

meet the criteria of MPI Bulletin 77–34

and its goals. The EPA does not have a

category of disinfectants specifically for

use in meat and poultry plants. FSIS has

since contacted EPA and requested that

EPA identify hospital disinfectant(s)

that might be suitable for use in red

meat and poultry plants.

Therefore, because the efficacy of the

180 °F water requirement is

questionable, the Agency is proposing to

remove the specific requirements for the

water temperature from § 308.8(c) of the

regulations. The proposed performance

standard also would replace other

prescriptive sanitation requirements for

equipment and utensils, such as the

requirements in § 308.16 concerning

electrical stimulating equipment and the

requirements in § 381.53(f) concerning

the construction of ice shovels used in

poultry establishments.

FSIS also is proposing that this

performance standard replace the

prohibitions against equipment and

utensils containing certain

concentrations of liquid polychlorinated

biphenyls (PCB’s) in §§ 308.5(g) and

381.56(b). The new standard would

effectively prohibit the use of any

equipment or utensils that could lead to

product contamination by PCB’s.

Food-Contact Surface Cleaning and

Sanitation—416.4(a)

In general, current Agency policy

requires that establishments clean food

contact surfaces daily. However, not all

of the pertinent current meat and

poultry regulations state that

equipment, utensils, and rooms be

maintained in a sanitary manner.

Proposed § 416.4(a) clarifies and

codifies Agency policy regarding daily

cleaning:

All food-contact surfaces, including foodcontact surfaces of utensils and equipment,

must be cleaned daily prior to starting

operations and as frequently as necessary so

that they are free of physical and chemical

contamination and so that microbiological

populations are reduced so as to prevent

contamination or adulteration of product.

This proposed performance standard

also clarifies the intent of the Sanitation

SOP regulations in § 416.2(c), which

require establishments to develop and

implement SOP’s that address the

cleaning of food contact surfaces,

equipment, and utensils.

The objective of food-contact surface

cleaning requirements has always been

to mitigate physical, chemical, and

microbiological contamination that

could contaminate or adulterate

product. The proposed performance

standard codifies this objective and

clarifies establishment responsibility for

determining how best to achieve it.

Some of the current regulations

regarding food-contact surface cleaning

are prescriptive and limit innovation by

the establishment. For example,

§ 381.58(g) requires that all conveyor

trays or belts which come into contact

with raw poultry products be

completely washed and sanitized after

each use. The intent of this requirement

is to minimize the growth of

microorganisms on the food contact

surface. There may be other more

efficient procedures that would

accomplish this objective, however, that

are not allowed by the current

requirements. The proposed

performance standard would allow

establishments to clean ‘‘as frequently

as necessary.’’ Additionally, the current

requirement in § 381.58(g) is not

applicable to cutting boards used for

poultry products, or conveyors and trays

used for red meat products. The

proposed performance standard also

would remove this inconsistency and

others like it.

Non-Food-Contact Surface Cleaning and

Sanitation—416.4(b)

FSIS also is proposing to replace the

current regulations concerning the

cleaning and sanitation of non-foodcontact surfaces with a performance

standard. For example, § 308.3(d)(4)

now requires that meat establishments

use 180 °F water for cleaning of floors,

and walls which are subject to

contamination by the dressing or

handling of diseased carcasses, their

viscera, and other parts. The intent of
45052 Federal Register / Vol. 62, No. 164 / Monday, August 25, 1997 / Proposed Rules

this regulation is to require

establishments to keep floors and walls

free of any physical contaminants (soil,

tissue debris), chemical contaminants or

biological contaminants that could

contaminate or adulterate a meat and

poultry product. The requirement to

prevent contamination or adulteration is

retained in the proposed performance

standard, but without the 180 °F water

provision. This gives establishments

greater flexibility and responsibility for

developing sanitary procedures specific

to the nature of their operations and the

food safety hazards which might occur.

Cleaning Compounds and Sanitizers—

416.4(c)

The current regulations in § 381.60

require that FSIS approve cleaning

compounds and sanitizers before they

can be used within an official poultry

establishment. FSIS policy has been to

enforce this requirement in meat plants

as well. The requirement is intended to

ensure that meat and poultry products

are not contaminated or adulterated

with chemicals or any injurious

substance. We are proposing to replace

this requirement with a performance

standard that would specify that

‘‘cleaning compounds and sanitizing

agents used must be safe and effective

under the conditions of use and their

use must not cause the contamination or

adulteration of product.’’ Of course,

establishments would still have to meet

the use requirements for the substances

promulgated by other regulatory

agencies, such as FDA and EPA.

Operational Sanitation—416.4(d)

The current requirements for

operational sanitation (sanitation

measures carried out during operations)

are spread throughout a number of

regulations. For example, the

requirements concerning rooms and

compartments in which meat product is

prepared or handled can be found in

both §§ 308.3(g) and 308.7. The

proposed regulations would consolidate

all of the operational sanitation

requirements in a single place.

Further, certain current requirements

for operational sanitation are

unnecessarily prescriptive. For example,

current § 381.47(e) stipulates that rooms

where mechanical equipment for

deboning of raw poultry is operated

must be maintained at 50 °F or less.

This requirement is intended to limit

growth of microorganisms resulting

from the rise in temperature of the

product as a consequence of the

mechanical grinding operation.

Temperatures of 50 °F or less slow the

growth rate of most organisms of

concern, especially Salmonella.

However, since this requirement was

promulgated, FSIS has permitted many

facilities, upon request, to use heatexchangers connected to the grinding

equipment to bring about an immediate

reduction in product temperature. Heatexchangers on the equipment can more

effectively reduce product temperature

and limit growth of microorganisms

than the requirement to maintain room

temperature.

FSIS is proposing to replace the room

temperature requirement with a

performance standard that will allow

establishments to devise their own

means for limiting microbial growth in

their processing operations, without

requesting special approval from the

Agency. The proposed performance

standard states that ‘‘Product must be

protected from contamination or

adulteration during processing,

handling, storage, loading and

unloading at and during transportation

from official establishments’’ and that

‘‘ready-to-eat product must be protected

from cross-contamination by pathogenic

organisms.’’

Under the standard, establishments

would be required to protect meat and

poultry products from contamination or

adulteration during all phases of

production. Establishments also would

be specifically required to protect readyto-eat products from cross

contamination, namely by raw product.

Establishments would need not only to

protect product from direct

contamination, but also to control the

temperature of product in order to

reduce microbial growth; in many

instances, FSIS considers microbial

growth to be indicative of insanitary

conditions. Establishments would be

free to take whatever measures they

believe are necessary, based upon the

nature and volume of their production.

Employee Hygiene—416.5(a)

The current regulations mandate

specific employee hygiene practices

establishments must adopt. For

example, the requirements in § 308.8(e)

specifically prohibit employees from

spitting and from placing ‘‘skewers,

tags, or knifes’’ into their mouths. Also,

§ 381.51(g) states that signs must be

posted in each toilet room directing

employees to wash their hands before

returning to work. The proposed

performance standard would allow

establishments to develop alternative or

innovative means to ensure that

employee hygiene practices do not

result in product adulteration or

contamination.

Employee Clothing—416.5(b)

Some of the current requirements

regarding employee clothing are

prescriptive. For example, § 308.8(d)

states that work garments shall be

changed during the day when required

by the inspector-in-charge. The

proposed performance standard would

require establishments to develop

acceptable policies for prescribing when

‘‘garments must be changed during the

day ... to prevent contamination or

adulteration of product.’’ The other

requirements of the current regulations,

that garments be made of material that

is readily cleaned and that clean

garments be worn at the start of each

day, are retained in the proposed

performance standard.

Employee Disease—416.5(c)

The proposed performance standard

regarding employee disease is similar to

the current requirements. The revision

would serve to consolidate regulations

for meat and poultry into a single

section.

Tagging Insanitary Equipment, Rooms,

or Compartments—416.6

Similar requirements for the tagging

of insanitary equipment, rooms, or

compartments are found in both the

meat and poultry regulations. Tagged

equipment, rooms, and compartments

tagged cannot be used until made

acceptable. The proposed standard will

not change current FSIS policy, but will

consolidate requirements for meat and

poultry into a single section.

FSIS is also proposing to revise

§ 381.99 of the poultry regulations.

Section 381.99 contains both tagging

provisions (which would be removed

and replaced by § 416.6) and

descriptions of different types of tags

(which would remain in section 381.99).

Custom Slaughter Establishments

Under current § 303.1(a)(2)(i),

establishments that conduct custom

slaughter operations must meet all of

the sanitation requirements contained in

Part 308, with a few exceptions. Custom

slaughter establishments currently are

exempt from the following:

• §§ 308.1 and 308.2—prior approval

requirements for sanitary conditions,

drawings, and blueprints;

• § 308.3(d) (2) and (3)—water reuse

restrictions;

• § 308.4—provisions requiring that

establishments have separate toilet

facilities for men and women (if a

majority of the custom slaughter

establishment’s employees are related

by blood or marriage and if this

arrangement will not conflict with

municipal or State requirements) and
Federal Register / Vol. 62, No. 164 / Monday, August 25, 1997 / Proposed Rules 45053

provisions requiring that toilet soil lines

be separate from house drainage lines to

a point outside the buildings (if positive

acting backflow devices are installed);

• § 308.12—restrictions regarding the

use of second-hand tubs, barrels, and

other containers;

• § 308.13—provisions requiring that

driveways, approaches, yards, pens, and

alleys be paved;

• § 308.16—sanitation requirements

for electrical stimulating equipment;

and

• any provisions of Part 308 relating

to inspection or supervision of specified

activities or other action by a Program

employee.

FSIS is proposing to retain the

exemptions in 303.1(a)(2)(i), but also to

modify them for consistency with the

proposed sanitation performance

standards in new Part 416. FSIS is

proposing to eliminate the requirements

in § 308.1 regarding examination of

sanitary conditions prior to

inauguration of inspection; the

requirements in § 308.4 regarding

separation of toilet lines; the

requirements in § 308.12 regarding the

use of second-hand tubs, barrels, and

other containers; the requirements in

§ 308.13 regarding surface paving; and

the requirements in § 308.16 regarding

the sanitation of electrical stimulating

equipment. Therefore, the revised

303.1(a)(2)(i) would not refer to

exemptions from these requirements.

Similarly, in a recent proposal (FSIS

Docket No. 95–032P; 61 FR 19587–

19590), FSIS eliminated the

requirements in § 308.2 concerning

prior approval of establishment

blueprints and drawings. The revised

303.1(a)(2)(i) therefore would not

include an exemption from these

requirements either.

Additional Regulatory and Policy

Revisions

The comprehensive nature of this

proposed rule would necessitate many

changes to FSIS policy documents and

regulatory references. FSIS will

complete all of the needed revisions

prior to the effective date of any final

rule emanating from this rulemaking.

These changes fall into two categories.

First, FSIS would need to revise all of

the cross-references in the meat and

poultry regulations to reflect the

proposed deletion of §§ 308 and 381

Subpart H and the proposed addition of

new §§ 416.1 through 416.6. These

revisions would be nonsubstantive.

Second, FSIS plans to rescind or revise

many sanitation issuances and

directives inconsistent with the

proposed rule and with HACCP.

Much of the material contained in the

rescinded or revised issuances and

directives would be re-formatted and

published as guidance materials

providing information, advice, and

suggestions on how the proposed

performance standards can be met. For

example, the contents of MPI Bulletin

83–16 (Re-Use of Water or Brine

Cooking Solution on Product Following

a Heat Treatment) will remain available

from the Agency as guidance material

for establishments to use in addressing

the proposed performance standards.

Some of the material has been used to

develop performance standards FSIS is

proposing or plans to propose. For

instance, material from FSIS Directive

7110.4 (Liquid Smoke Re-Use) was used

to develop the proposed performance

standard for solution re-use.

Issuances To Be Rescinded by the

Agency

FSIS would rescind the following

directives and issuances prior to the

finalization of this proposal:

Approved Water Systems Guide

FSIS Directive 7110.4—Liquid Smoke

Re-Use

FSIS Directive 11,100.1—Sanitation

Handbook

FSIS Directive 11,000.2—Plant

Sanitation

FSIS Directive 11,000.4—Paints and

Coatings in Official Establishments

FSIS Directive 11,210.1—Protecting

Potable Water Supplies on Official

Premises

FSIS Directive 11,220.2—Guidelines for

Sanitization of Automatic Poultry

Eviscerating Equipment

FSIS Directive 11,240.5—Plastic Cone

Deboning Conveyors

FSIS Directive 11,520.2—Exposed HeatProcessed Products; Employee

Dress

FSIS Directive 11,520.4—Strip Doors in

Official Establishments

FSIS Directive 11,540.1—Use of Certain

Vehicles as

Refrigeration or Dry Storage Facilities

MPI Bulletin 77–34—Chemical

Disinfection in Lieu of 180° F Water

MPI Bulletin 77–129—Water

Conservation and Sanitation

MPI Bulletin 79–68—Use of Iodine in

Processing Water

MPI Bulletin 81–38—Equipment and

Procedure Requirements for

Processing Gizzards

MPI Bulletin 83–14—Monitoring

Chlorine Concentration in

Official Establishments

MPI Bulletin 83–16—Re-Use of Water or

Brine Cooking Solution on Product

Following a Heat Treatment

Executive Order 12866 and Regulatory

Flexibility Act

This proposed rule has been reviewed

under Executive Order 12866. The rule

has been determined to be significant

for the purposes of Executive Order

12866 and, therefore, has been reviewed

by the Office of Management and

Budget.

In accordance with 5 U.S.C. 603, FSIS

has performed an Initial Regulatory

Flexibility Analysis, which is set out

below, regarding the impact of this rule

on small entities. However, FSIS does

not currently have all the data necessary

for a comprehensive analysis of the

effects of this rule on small entities.

Therefore, FSIS is inviting comments

concerning potential effects. In

particular, FSIS is interested in

determining the number and kind of

small entities that may incur benefits or

costs from implementation of this

proposed rule.

FSIS is proposing to revise and

consolidate the sanitation regulations

for meat and poultry establishments,

resolve unnecessary differences between

similar requirements for meat and

poultry, and convert prescriptive

requirements to performance standards.

This proposal would affect meat and

poultry establishments subject to official

inspection, custom exempt red meat

establishments, and consumers.

In general, the proposed streamlining,

clarification, and consolidation of the

sanitation regulations should benefit

FSIS, the regulated industry, and

consumers. User-friendly regulations

would simplify compliance and

therefore could bring about food safety

enhancements in individual

establishments. Further, consolidation

of the separate sanitation requirements

for meat and poultry products and the

consequent elimination of unnecessary

inconsistencies could enhance

competition.

This proposed rule would allow

individual establishments to develop

and implement customized sanitation

procedures other than those currently

mandated, as long as those procedures

produced sanitary conditions meeting

the proposed performance standards.

Establishments taking advantage of the

performance standards to innovate thus

could benefit from savings accrued

through increased efficiency. However,

since the currently mandated sanitation

procedures meet the proposed

performance standards, establishments

lacking the resources to innovate could

choose to continue employing current

procedures. Such establishments should

incur no additional expenses as a result

of this rule. FSIS therefore anticipates
45054 Federal Register / Vol. 62, No. 164 / Monday, August 25, 1997 / Proposed Rules

that sanitation performance standards

would have a generally favorable

economic impact on all establishments,

regardless of size.

It is difficult to quantify the potential

benefits of the proposed performance

standards since it is not possible to

predict exactly how many

establishments would develop

innovative processes and how these

innovations reduce. However, FSIS sees

the potential for an increase in the

efficiency of the nation’s economy in

general because the proposed

performance standards would stimulate

innovation and encourage businesses to

consider a more efficient use of

resources. Also, the possibility of

subsequently reduced prices of meat or

poultry products are economic factors

that could produce a more efficient use

of resources in the economy as a whole.

These effects would be small for

individual firms and consumers, but

could be substantial in the aggregate.

Finally, FSIS is restructuring

inspection activities to focus more

attention on the ability of

establishments to maintain a sanitary

environment through implementation of

the new Sanitation SOP requirements.

This proposal is part of that initiative

and is intended to reduce demands on

FSIS resources which could be

redirected to functions more critical to

improving food safety. FSIS anticipates

that this proposal, along with the

HACCP, Sanitation SOP, and other food

safety initiatives, would produce

significant economic and societal

benefits by reducing the incidence of

foodborne illness.

As an alternative to the present

proposal, the Agency considered

proposing more comprehensive and

prescriptive sanitation regulations. The

proposed requirements would then have

included very specific definitions of

terms, such as definitions for food

contact surfaces or premises; more

prescriptive performance standards than

those proposed, such as microbial

criteria for recently cleaned and

sanitized food contact surfaces; detailed

requirements currently contained in

Agency guidance materials, such as an

ambient temperature requirement for

rooms in which certain processes are

conducted; and a list of specific

regulatory prohibitions, again largely

drawn from existing regulatory and

guidance material.

The Agency did not choose this more

detailed and prescriptive alternative,

due to the unnecessarily restrictive

burden it would place on industry, and

has made tentative decisions in these

areas, on which it specifically requests

comments. On the matter of definitions,

the Agency has determined that within

the food processing community and the

meat and poultry processing industry

there is an understanding of descriptive

terms such as ‘‘food contact surfaces’’

and ‘‘premises,’’ and that to construct a

technically accurate definition which

encompassed all the possible meat and

poultry establishment situations in

which the term could be applied was

neither useful nor likely to succeed. The

Agency notes, however, that these and

other terms are defined in both the Food

Code and in certain FDA regulations

and specifically requests comment on

whether those definitions ought to be

referenced in FSIS regulations.

Similarly, the Agency has made a

tentative decision that a proliferation of

prescriptive standards applicable to the

establishment environment or its

features, like ambient temperature or

microbial characteristics of cleaned

equipment, would not be a useful

addition to the proposed standards,

which are based on the general

requirement that establishments prevent

product contamination or adulteration.

At various other places in its

regulations, the Agency has established

performance standards applicable to

meat and poultry products. The newest

is the Salmonella performance standard

for raw carcasses and ground product

established in the Pathogen Reduction/

HACCP final regulation. Another is the

zero tolerance standard for fecal

material on raw carcasses. Others

include the prohibition on violative

levels of chemical residues and the

policy that there be no Listeria or

Salmonella on certain ready-to-eat

products. Achieving these productbased performance standards depends

on an establishment doing a number of

things correctly, including correctly

carrying out the sanitation

responsibilities set forth in part 416.1

through 416.6. FSIS has tentatively

concluded that because there are many

methods and means through which

establishments can ensure that product

is not contaminated or adulterated, FSIS

will not prescribe exactly which

methods, procedures, or means must be

used. FSIS requests comment on this

tentative decision.

FSIS is carefully reviewing its

guidance material on sanitation in an

effort to develop the most

comprehensive possible set of

approaches which can be considered by

establishments as they determine how

they will go about meeting the

performance standards. If that reviews

yields provisions which should become

parts of the performance standards, FSIS

will revise its regulations accordingly. If

the review yields a number of possible

approaches which could be used by an

establishment, they will all be included

in guidance material, which FSIS

expects to complete by the time this

proposal is made final.

Finally, on the issue of whether there

should be a list of specific prohibited

practices retained in the regulations,

FSIS has made a tentative decision that

this is not necessary and could be

misleading. Most of the prohibited

practices which are mentioned in the

current sanitation regulations represent

only one or a small fraction of the ways

in which establishments could fail to

meet a performance standard. For

example, using burlap as a wrap directly

applied to the surface of meat is only

one of the means by which an

establishment could be failing to

prevent direct product contamination.

Preventing direct product

contamination is the performance

standard. It encompasses a prohibition

on using burlap as a wrap, as well as a

large number of other practices. The

Agency believes that a partial or

outdated list of regulatory prohibitions

may suggest that anything not on the list

is not prohibited. FSIS prefers to

communicate about unsuitable practices

through its guidance material, while

holding establishments directly

responsible for meeting concisely

defined performance standards which

mitigate against a wide range of

unsuitable practices.

The other alternative available to FSIS

was to maintain the current sanitation

requirements. However, as explained in

detail above, the current requirements

are to an extent inconsistent with the

principles of HACCP, can impede

innovation, and often can lead to

confusion about FSIS and establishment

responsibilities for food safety.

Executive Order 12778

This proposed rule has been reviewed

under Executive Order 12778, Civil

Justice Reform. States and local

jurisdictions are preempted by the

Federal Meat Inspection Act and the

Poultry Products Inspection Act (PPIA)

from imposing any marking, labeling,

packaging, or ingredient requirements

on federally inspected meat and poultry

products that are in addition to, or

different than, those imposed under the

FMIA or the 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
Federal Register / Vol. 62, No. 164 / Monday, August 25, 1997 / Proposed Rules 45055

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 proposed rule, if the

challenge involves any decision of an

FSIS employee relating to inspection

services provided under the FMIA or

the PPIA.

Executive Order 12898

Pursuant to Executive Order 12898

(59 FR 7629, February 16, 1994),

‘‘Federal Actions to Address

Environmental Justice in Minority

Populations and Low-Income

Populations,’’ FSIS has considered

potential impacts of this proposed rule

on environmental and health conditions

in low-income and minority

communities.

This proposed rule would consolidate

the sanitation regulations for meat and

poultry establishments into a single

part, eliminate unnecessary differences

between the meat and poultry sanitation

requirements, and convert many of the

highly prescriptive requirements to

performance standards. As explained in

the economic impact analysis above, the

proposed regulations should generally

benefit FSIS, the regulated industry, and

consumers. The proposed regulations

would not require or compel meat or

poultry establishments to relocate or

alter their operations in ways that could

adversely affect the public health or

environment in low-income and

minority communities. Further, this

proposed rule would not exclude any

persons or populations from

participation in FSIS programs, deny

any persons or populations the benefits

of FSIS programs, or subject any persons

or populations to discrimination

because of their race, color, or national

origin.

Paperwork Requirements

Abstract: FSIS has reviewed the

paperwork and recordkeeping

requirements in this proposed rule in

accordance with the Paperwork

Reduction Act.

Under the current regulations, if meat

and poultry establishments are cited for

rodent or vermin infestation, FSIS

requires establishments to develop a

written corrective action report. The

Office of Management and Budget

(OMB) under control number O583–

0082, ‘‘Meat and Poultry Inspection and

Application for Inspection,’’ has

approved 351 burden hours for this

activity.

This proposed rule would eliminate

the requirement that establishments

develop rodent and vermin infestation

corrective action reports. Corrective

action measures for rodent and vermin

infestation will be part of

establishments’ Sanitation SOP’s. The

burden hours reported for Sanitation

SOP’s includes the development of

these corrective actions. Therefore, FSIS

would request OMB to remove the 351

burden hours approved for the

development of rodent and vermin

infestation corrective action reports.

Also, proposed § 416.2(g)(1) requires

that establishments, upon request, make

available to FSIS ‘‘water reports issued

under the authority of the State health

agency certifying or attesting to the

quality of the water supply.’’ This

paperwork collection requirement

already is in place under the current

regulations and is approved under OMB

control number O583–0082, ‘‘Meat and

Poultry Inspection and Application for

Inspection.’’

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 Desk Officer for

Agriculture, Office of Information and

Regulatory Affairs, Office of

Management and Budget, Washington,

DC 20253.

Comments are requested by October

24, 1997. 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 Part 303

Meat inspection, Reporting and

recordkeeping requirements.

9 CFR Part 308

Meat inspection.

9 CFR Part 381

Poultry and poultry products

inspection, Reporting and

recordkeeping requirements.

9 CFR Part 416

Sanitation.

Accordingly, title 9, chapter III, of the

Code of Federal Regulations would be

amended as follows:

PART 303—EXEMPTIONS

1. The authority citation for part 303

would continue to read as follows:

Authority: 21 U.S.C. 601–695; 7 CFR 2.17,

2.55.

2. Section 303.1 would be amended

by revising paragraph (a)(2)(i) to read as

follows:

§ 303.1 Exemptions.

(a) * * *

(2) * * *

(i) Establishments conducting custom

slaughter operations must be

maintained and operated in accordance

with the provisions of part 416 except

for: §§ 416.2(g) (1) through (7), regarding

water reuse; the provision in § 416.2(i)

requiring that separate toilet facilities be

provided where both sexes are

employed (if the majority of the workers

in the custom slaughter establishment

are related by blood or marriage and this

arrangement will not conflict with

municipal or State requirements); and

any provisions of part 416 relating to

inspection or supervision of specified

activities or other action by a Program

employee. If custom operations are

conducted in an official establishment,

however, all of the provisions of Part

416 shall apply to those operations.

* * * * *

PART 308—[REMOVED]

3.–4. Part 308 would be removed.

PART 381—POULTRY PRODUCTS

INSPECTION REGULATIONS

5. The authority citation for part 381

would continue to read as follows:

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

U.S.C. 451–470; 7 U.S.C. 2.18, 2.53.

Subpart H—[Removed]

6. Subpart H would be removed.
45056 Federal Register / Vol. 62, No. 164 / Monday, August 25, 1997 / Proposed Rules

7. Section 381.99 would be revised to

read as follows:

§ 381.99 Official retention and rejection

tags.

The official marks for use in postmortem inspection and identification of

adulterated products, insanitary

equipment and facilities are:

(a) A paper tag (a portion of Form

MP–35) bearing the legend ‘‘U.S.

Retained’’ for use on poultry or poultry

products under this section.

(b) A paper tag (another portion of

Form C&MS 510) bearing the legend

‘‘U.S. Rejected’’ for use on equipment,

utensils, rooms and compartments

under this section.

PART 416—SANITATION

8. The authority citation for part 416

would continue to read as follows:

Authority: 21 U.S.C. 451–470, 601–680; 7

U.S.C. 450; 7 CFR 2.18, 2.53.

9. Part 416 would be amended by

adding new §§ 416.1 through 416.6, to

read as follows:

§ 416.1 General rules.

Each official establishment must be

operated and maintained in a sanitary

manner sufficient to ensure that product

is not contaminated, adulterated, or

misbranded.

§ 416.2 Establishment grounds and

facilities.

(a) Grounds and pest control. The

grounds about an establishment must be

maintained to prevent conditions that

could lead to contamination or

adulteration of product or that could

prevent FSIS programs employees from

performing assigned tasks.

Establishments must have in place an

integrated pest management program to

prevent the harborage and breeding of

pests on the grounds and within

establishment facilities. Pest control

substances used must be safe and

effective under the conditions of use

and not result in the contamination or

adulteration of product.

(b) Construction. (1) Establishment

buildings, including their structures,

rooms, and compartments must be of

sound construction, kept in good repair,

and be of sufficient size to allow for the

sanitary processing, handling, and

storage of product.

(2) Walls, floors, and ceilings within

establishments must be built of durable

materials impervious to moisture and be

cleaned, maintained, and sanitized

when necessary to prevent

contamination or adulteration of

product.

(3) Walls, floors, ceilings, doors,

windows, and other outside openings

must be constructed and maintained to

prevent the entrance of vermin, such as

flies, rats, and mice.

(4) Rooms or compartments in which

edible product is processed, handled, or

stored must be separate and distinct

from rooms or compartments in which

inedible product is processed, handled,

or stored.

(c) Light. Lighting of good quality and

sufficient intensity to ensure that

sanitary conditions are maintained and

that product is not contaminated,

adulterated or misbranded must be

provided in areas where food is

processed, handled, stored, or

examined, where equipment and

utensils are cleaned, and in handwashing areas, dressing and locker

rooms, and toilets.

(d) Ventilation. Ventilation adequate

to eliminate odors, vapors, and

condensation must be provided to

prevent contamination or adulteration

of product and to ensure that FSIS

programs employees can perform

assigned tasks.

(e) Plumbing. Plumbing systems must

be installed and maintained to:

(1) Carry sufficient quantities of water

to required locations throughout the

establishment;

(2) Properly convey sewage and liquid

disposable waste from the

establishment;

(3) Prevent contamination or

adulteration of product, water supplies,

equipment, or utensils, and maintain

sanitary conditions throughout the

establishment;

(4) Provide adequate floor drainage in

all areas where floors are subject to

flooding-type cleaning or where normal

operations release or discharge water or

other liquid waste on the floor; and

(5) Prevent back-flow conditions in

and cross-connection between piping

systems that discharge waste water or

sewage and piping systems that carry

water for product manufacturing;

(6) Prevent the backup of sewer gases.

(f) Sewage disposal. Sewage must be

disposed into a sewage system separate

from all other drainage lines or disposed

of through other means sufficient to

prevent backup of sewage into areas

where product is processed, handled, or

stored. When the sewage disposal

system is a private system requiring

approval by a State or local health

authority, the establishment must be

able to furnish FSIS with the letter of

approval from that authority upon

request.

(g) Water supply and reuse. (1) A

supply of running water that complies

with the National Primary Drinking

Water regulations (40 CFR Part 141), at

a suitable temperature and under

pressure as needed, must be provided in

all areas where required (for processing

product, for cleaning rooms and

equipment, utensils, and packaging

materials, for employee sanitary

facilities, etc.). A water report, issued

under the authority of the State health

agency, certifying or attesting to the

quality of the water supply, must be

made available to the Agency upon

request.

(2) Water used to chill or cook readyto-eat product may be reused for the

same purpose, provided that measures

are taken to ensure that it is maintained

free of pathogenic organisms and fecal

coliform organisms and that other

physical, chemical, and microbiological

contamination is reduced so as to

prevent contamination or adulteration

of product.

(3) Water used to chill or wash raw

product may be reused for the same

purpose provided that measures are

taken to reduce physical, chemical, and

microbiological contamination so as to

prevent contamination or adulteration

of product. Reuse water which has come

into contact with raw product may not

be used on ready-to-eat product.

(4) Reconditioned water that has

never contained human waste and

which has been treated by an onsite

advanced wastewater treatment facility

may be used on raw product, except in

product formulation, and throughout

the facility in edible and inedible

production areas, provided that

measures are taken to assure that this

water meets the criteria prescribed in

paragraph (g)(1) of this section. Product,

facilities, equipment, and utensils

coming in contact with this water must

undergo a separate final rinse with nonreconditioned water that meets the

criteria prescribed in paragraph (g)(1) of

this section.

(5) Any water that has never

contained human waste and is free of

pathogenic organisms may be used in

edible and inedible product areas,

provided it does not contact edible

product. For example, such reuse water

may be used to move heavy solids, flush

the bottom of open evisceration troughs,

or to wash antemortem areas, livestock

pens, trucks, poultry cages, picker

aprons, picking room floors, and similar

areas within the establishment.

(6) Water which does not meet the use

conditions of paragraphs (g)(1) through

(g)(5) of this section, may not be used

in areas where edible product is

handled or prepared or in any manner

which would allow it to contaminate or

adulterate edible product.

(h) Ice and solution reuse. (1) Ice used

or reused must have been originally

produced from water meeting the
Federal Register / Vol. 62, No. 164 / Monday, August 25, 1997 / Proposed Rules 45057

requirements of paragraphs (g)(1) of this

section.

(2) Ice used on raw product may not

be reused on ready-to-eat product.

(3) Ice or solutions (such as brine,

liquid smoke, or propylene glycol) may

be reused on ready-to-eat product if they

are free of pathogenic and fecal

coliforms and if other physical,

chemical, and microbiological

contamination has been reduced so as to

prevent the contamination or

adulteration of product.

(4) Ice or solutions may be reused on

raw and partially-cooked product if they

are free of fecal coliforms and if other

physical, chemical and microbiological

contamination has been reduced so as to

prevent the adulteration of product.

(i) Dressing rooms, lavatories, and

toilets. (1) Dressing rooms, toilet rooms,

and urinals must be sufficient in

number, ample in size, conveniently

located, and maintained in a sanitary

condition and in good repair at all times

to ensure cleanliness of all persons

handling any product. They must be

separate from the rooms and

compartments in which products are

processed, stored, or handled. Where

both sexes are employed, separate

facilities must be provided.

(2) Lavatories with running hot and

cold water, soap, and towels, must be

placed in or near toilet and urinal rooms

and at such other places in the

establishment as necessary to ensure

cleanliness of all persons handling any

product.

(3) Refuse receptacles constructed and

maintained in a manner that protects

against contamination or adulteration of

food must be provided.

§ 416.3 Equipment and utensils.

(a) Equipment and utensils used for

processing or otherwise handling edible

product or ingredient must be of such

material and construction to facilitate

thorough cleaning and ensure that

product is not contaminated,

adulterated, or misbranded during

processing, handling, or storage.

Equipment and utensils must be

maintained in sanitary condition so as

not to contaminate or adulterate

product.

(b) Equipment and utensils must not

interfere with inspection procedures or

prevent FSIS programs employees from

performing assigned tasks.

(c) Receptacles used for storing

inedible material must be of such

material and construction that their use

will not result in contamination or

adulteration of any edible product or in

insanitary conditions at the

establishment. They must not be used

for storing any edible product and must

bear conspicuous and distinctive

marking to identify permitted uses.

§ 416.4 Sanitary operations.

(a) All food-contact surfaces,

including food-contact surfaces of

utensils and equipment, must be

cleaned daily prior to starting

operations and as frequently as

necessary so that they are free of

physical and chemical contamination

and so that microbiological populations

are reduced so as to prevent

contamination or adulteration of

product.

(b) Non-food-contact surfaces of

facilities, equipment, and utensils used

in the operation of the establishment

must be cleaned as frequently as

necessary to prevent the physical,

chemical, or biological contamination or

adulteration of product.

(c) Cleaning compounds and

sanitizing agents used must be safe and

effective under the conditions of use

and their use must not cause the

contamination or adulteration of

product.

(d) Product must be protected from

contamination or adulteration during

processing, handling, storage, loading,

and unloading at and during

transportation from official

establishments; ready-to-eat product

must be protected from crosscontamination by pathogenic organisms.

§ 416.5 Employee hygiene.

(a) Cleanliness. All persons working

in contact with product, food-contact

surfaces, and product-packaging

materials must adhere to hygienic

practices while on duty to prevent

contamination or adulteration of

product.

(b) Clothing. Aprons, frocks, and other

outer clothing worn by persons who

handle product must be of material that

is readily cleaned. Clean garments must

be worn at the start of each working day

and garments must be changed during

the day as often as necessary to prevent

contamination or adulteration of

product.

(c) Disease control. Any person who

has or appears to have an illness, open

lesion, including boils, sores, or infected

wounds, or any other abnormal source

of microbial contamination must be

excluded from any operations which

could result in product contamination

or adulteration until the condition is

corrected.

§ 416.6 Tagging insanitary equipment,

utensils, rooms or compartments.

When a Program employee finds that

any equipment, utensil, room, or

compartment at an official

establishment is unclean or that its use

would be in violation of any of the

regulations in this subchapter, he will

attach to it a ‘‘U.S. Rejected’’ tag.

Equipment, utensils, rooms, or

compartments so tagged cannot be used

until made acceptable. Only a Program

employee may remove a ‘‘U.S. Rejected’’

tag.

Done in Washington, DC on: August 11,

1997.

Thomas J. Billy,

Administrator.

[FR Doc. 97–21881 Filed 8–22–97; 8:45 am]

BILLING CODE 3410–DM–P