Sanitation Requirements for Official Meat and Poultry Establishments

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understand, redundant, or outdated.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

[[Page 45046]]

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 Secs. 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.

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Subject Proposed regulation Current regulation(s)

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

General sanitation...................... Sec. 416.1.......................... Secs. 308.3(a), (g), 308.7,

381.45, 381.57; and all other

provisions not listed below.

Establishment grounds and pest Sec. 416.2(a)....................... Secs. 308.3 (h), 308.13,

management. 381.49(b), 381.56(a), 381.59,

and 381.60.

Establishment Construction.............. Sec. 416.2(b)....................... Secs. 308.3(e), (f), (h),

381.46, 381.47 and 381.48.

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

(b).

Ventilation............................. Sec. 416.2(d)....................... Secs. 308.3 (b) and (g),

308.8(b), 381.52 (a) and (c).

Plumbing................................ Sec. 416.2(e)....................... Secs. 308.3(c), 381.47(b),

381.49 (a), (b) and (c).

Sewage disposal......................... Sec. 416.2(f)....................... Secs. 308.4(c) and

381.49(c)(4).

Water supply and reuse.................. Sec. 416.2(g)....................... Secs. 308.3(d), 381.50 and

381.53(k).

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

Dressing rooms, lavatories, and toilets. Sec. 416.2(i)....................... Secs. 308.4 (a), (b), (d),

381.47(h), 381.51 and

381.53(c).

Equipment and utensils.................. Sec. 416.3.......................... Secs. 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 Sec. 416.4(a)....................... Secs. 308.3(d)(4), 308.7,

sanitation. 308.8(a), 381.57 and 381.58.

Non-food-contact surface cleaning and Sec. 416.4(b)....................... Secs. 308.3(d)(4), 308.7,

sanitation. 308.8(a), 381.57 and 381.58.

Cleaning compounds and sanitizers....... Sec. 416.4(c)....................... Sec. 381.60.

[[Page 45047]]

Operational sanitation.................. Sec. 416.4(d)....................... Secs. 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........................ Sec. 416.5(a)....................... Secs. 308.8(c),(e), 381.47(i),

381.51(g), 381.61(b),(c), and

(d).

Employee clothing....................... Sec. 416.5(b)....................... Secs. 308.8(d) and 381.61(b).

Employee disease........................ Sec. 416.5(c)....................... Secs. 308.14 and 381.61(a).

Tagging insanitary equipment, rooms, or Sec. 416.6.......................... Secs. 308.15 and 381.99.

compartments.

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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 Sec. 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: Secs. 308.3(i) and 381.59, concerning dogs, cats,

and other animals on establishment premises; Sec. 308.8(f), concerning

equipment that generates gases or odors in meat establishments; and

Sec. 381.47 paragraphs (f) and (g), concerning general sanitary

conditions in poultry establishment storage and boiler rooms.

Establishment Grounds and Pest Management--Sec. 416.2(a)

The current requirements for facility grounds are somewhat

prescriptive and inconsistent. For example, Sec. 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 Sec. 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, Secs. 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

Sec. 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 Sec. 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, Sec. 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 Sec. 308.3 (e), (f),

and (h) of the red meat regulations. The proposed performance standards

in Sec. 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

[[Page 45048]]

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

Sec. 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 Sec. 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 Sec. 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 Secs. 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 Sec. 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, Sec. 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; Sec. 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 (Secs. 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

Sec. 308.3(d)(4), meat establishments are required to have an ample

supply of water of at least 180 deg. 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

[[Page 45049]]

substantive and material questions about the efficacy of the 180 deg. F

water for sanitization, the Agency is proposing to eliminate the

requirement (see the discussion below under ``Equipment and Utensils--

416.3'').

Also, under Sec. 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

Sec. 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 Sec. 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 Sec. 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 Sec. 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 Sec. 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

[[Page 45050]]

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 non-reconditioned 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 Sec. 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 Sec. 416.2(h) are

similar to those proposed for water reuse.

The performance standards proposed for reuse of ice or solutions on

ready-to-eat product (Sec. 416.2(h)(3)) serve the same purpose as those

proposed for water reuse on ready-to-eat product (Sec. 416.2(g)(5)).

The proposed performance standards for reuse of ice or solutions on raw

or partially-cooked product (Sec. 416.2(h)(4)) are slightly different

than those proposed for water reuse on raw products (Sec. 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 cross-contamination 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, Sec. 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

Secs. 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 Sec. 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 deg. F or a disinfectant approved by the

Administrator and that they then be rinsed in clean water. This

requirement, and the 180 deg.F water requirement specified in

Sec. 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 deg.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

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

\1\ Peel, 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.

\2\ Peel, B., and Simmons, G.C. (1978) Factors in the Spread of

Salmonellae in Meatworks with Special Reference to Contamination of

Knives. Australian Veterinary Journal 54: 106-110.

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

[[Page 45051]]

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 deg.F water bath. Husband and McPhail 3

studied the specific effects of the use of sprayed 180 deg.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 deg.F, the temperatures recorded at

1, 2, and 3 meter points along the water stream were 176 deg.F, 169

deg.F, and 163 deg.F respectively. A maximum temperature of only 127

deg.F was obtained at the boning table surface when water at an initial

nozzle temperature of 180 deg.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 deg.F in a boning room with an initial ambient temperature of 50

deg.F.

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

\3\ Husband, P. And McPhail, N.G. (1978) The Use of 82 deg.C

Water in Meat Plant Cleaning Operations. CSIRO Meat Research Report

No. 2/78. Commonwealth Scientific and Industrial Research

Association.

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

Husband and McPhail 4 also claimed that water at 120

deg.F nozzle temperature was as effective as water at 180 deg.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 deg.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.

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

\4\ Ibid.

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

Attempts to ``disinfect'' with chemical agents or 180 deg.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 deg.F water caused coagulation of

protein. Protein and fat remained on the examined metal, plastic, and

ceramic tile surfaces. They recommended 165 deg.F water for 30 seconds

to clean, but not disinfect, these surfaces in slaughterhouses.

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

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

Optimum Water Temperature for Cleaning Slaughterhouses?

Fleischwirtschaft 56(12): 1725-1728.

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

In the 1970's, the need for energy conservation created interest in

the use of chemical disinfectants in lieu of 180 deg.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 deg.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 deg.F water requirement

is questionable, the Agency is proposing to remove the specific

requirements for the water temperature from Sec. 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 Sec. 308.16 concerning electrical stimulating

equipment and the requirements in Sec. 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

Secs. 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 Sec. 416.4(a)

clarifies and codifies Agency policy regarding daily cleaning:

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.

This proposed performance standard also clarifies the intent of the

Sanitation SOP regulations in Sec. 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, Sec. 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 Sec. 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-food-contact surfaces

with a performance standard. For example, Sec. 308.3(d)(4) now requires

that meat establishments use 180 deg.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

[[Page 45052]]

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 deg.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 Sec. 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 Secs. 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 Sec. 381.47(e)

stipulates that rooms where mechanical equipment for deboning of raw

poultry is operated must be maintained at 50 deg.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 deg.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 heat-exchangers connected to the

grinding equipment to bring about an immediate reduction in product

temperature. Heat-exchangers 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 ready-to-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

Sec. 308.8(e) specifically prohibit employees from spitting and from

placing ``skewers, tags, or knifes'' into their mouths. Also,

Sec. 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, Sec. 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 Sec. 381.99 of the poultry

regulations. Section 381.99 contains both tagging provisions (which

would be removed and replaced by Sec. 416.6) and descriptions of

different types of tags (which would remain in section 381.99).

Custom Slaughter Establishments

Under current Sec. 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:

Secs. 308.1 and 308.2--prior approval requirements for

sanitary conditions, drawings, and blueprints;

Sec. 308.3(d) (2) and (3)--water reuse restrictions;

Sec. 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

[[Page 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);

Sec. 308.12--restrictions regarding the use of second-hand

tubs, barrels, and other containers;

Sec. 308.13--provisions requiring that driveways,

approaches, yards, pens, and alleys be paved;

Sec. 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 Sec. 308.1 regarding examination of sanitary

conditions prior to inauguration of inspection; the requirements in

Sec. 308.4 regarding separation of toilet lines; the requirements in

Sec. 308.12 regarding the use of second-hand tubs, barrels, and other

containers; the requirements in Sec. 308.13 regarding surface paving;

and the requirements in Sec. 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 Sec. 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 Secs. 308 and 381 Subpart H and the

proposed addition of new Secs. 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 Heat-Processed 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 deg. 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

[[Page 45054]]

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 product-

based 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

[[Page 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

Secs. 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 Sec. 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:

Sec. 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: Secs. 416.2(g) (1) through (7), regarding water reuse; the

provision in Sec. 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.

[[Page 45056]]

7. Section 381.99 would be revised to read as follows:

Sec. 381.99 Official retention and rejection tags.

The official marks for use in post-mortem 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 Secs. 416.1 through

416.6, to read as follows:

Sec. 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.

Sec. 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 hand-washing 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 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.

(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 non-reconditioned 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

[[Page 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.

Sec. 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.

Sec. 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 cross-contamination by pathogenic

organisms.

Sec. 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.

Sec. 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