[Federal Register Volume 62, Number 164 (Monday, August 25, 1997)]
[Proposed Rules]
[Pages 45045-45057]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-21881]



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

[[Page 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.

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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.

----------------------------------------------------------------------------------------------------------------
                 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.                                                                                                  
----------------------------------------------------------------------------------------------------------------

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