[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.
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Subject Proposed regulation Current regulation(s)
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General sanitation...................... Sec. 416.1.......................... Secs. 308.3(a), (g), 308.7,
381.45, 381.57; and all other
provisions not listed below.
Establishment grounds and pest Sec. 416.2(a)....................... Secs. 308.3 (h), 308.13,
management. 381.49(b), 381.56(a), 381.59,
and 381.60.
Establishment Construction.............. Sec. 416.2(b)....................... Secs. 308.3(e), (f), (h),
381.46, 381.47 and 381.48.
Light................................... Sec. 416.2(c)....................... Secs. 308.3(b), 381.52 (a) and
(b).
Ventilation............................. Sec. 416.2(d)....................... Secs. 308.3 (b) and (g),
308.8(b), 381.52 (a) and (c).
Plumbing................................ Sec. 416.2(e)....................... Secs. 308.3(c), 381.47(b),
381.49 (a), (b) and (c).
Sewage disposal......................... Sec. 416.2(f)....................... Secs. 308.4(c) and
381.49(c)(4).
Water supply and reuse.................. Sec. 416.2(g)....................... Secs. 308.3(d), 381.50 and
381.53(k).
Ice and solution reuse.................. Sec. 416.2(h)....................... FSIS policy (explained below).
Dressing rooms, lavatories, and toilets. Sec. 416.2(i)....................... Secs. 308.4 (a), (b), (d),
381.47(h), 381.51 and
381.53(c).
Equipment and utensils.................. Sec. 416.3.......................... Secs. 308.5 (a) and (g),
308.6, 308.8(c), 308.16,
381.53(a)(1), (f), (g), (h),
(i), (j), (k), (l), (m),
381.54, 381.55 and 381.56(b).
Food-contact surface cleaning and Sec. 416.4(a)....................... Secs. 308.3(d)(4), 308.7,
sanitation. 308.8(a), 381.57 and 381.58.
Non-food-contact surface cleaning and Sec. 416.4(b)....................... Secs. 308.3(d)(4), 308.7,
sanitation. 308.8(a), 381.57 and 381.58.
Cleaning compounds and sanitizers....... Sec. 416.4(c)....................... Sec. 381.60.
[[Page 45047]]
Operational sanitation.................. Sec. 416.4(d)....................... Secs. 308.3(g), 308.7,
308.8(a), 308.9, 308.10,
308.11, 308.12, 381.47(e),
381.53(d),(e), and (g)(4).
Employee hygiene........................ Sec. 416.5(a)....................... Secs. 308.8(c),(e), 381.47(i),
381.51(g), 381.61(b),(c), and
(d).
Employee clothing....................... Sec. 416.5(b)....................... Secs. 308.8(d) and 381.61(b).
Employee disease........................ Sec. 416.5(c)....................... Secs. 308.14 and 381.61(a).
Tagging insanitary equipment, rooms, or Sec. 416.6.......................... Secs. 308.15 and 381.99.
compartments.
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The Proposed Regulations
This proposed rule would significantly reduce the number of
sanitation regulations and consolidate the sanitation requirements for
meat and poultry into part 416. This consolidation would not only
simplify the sanitation regulations for the user, but also would
establish uniform sanitation performance standards that would provide
flexibility to establishments while maintaining the rigorous sanitation
standards necessary to ensure food safety. The establishment's
responsibility for maintaining sanitary conditions and preventing the
contamination and adulteration of product would remain unchanged.
Further, in consolidating the sanitation regulations, FSIS would
eliminate the unnecessary differences between the current sanitation
requirements for meat and poultry establishments. In the following,
FSIS has provided brief descriptions of the proposed sanitation
performance standards accompanied by examples of current regulations
they would replace.
General Sanitation--416.1
The current sanitation regulations for meat and poultry require in
general that rooms, compartments, and other parts of the official
establishment be kept clean and sanitary. New Sec. 416.1 sets out
similar requirements, but as a performance standard: ``Each official
establishment must be operated and maintained in sanitary manner
sufficient to ensure that product is not contaminated, adulterated, or
misbranded.'' As discussed above and illustrated by the chart, FSIS is
proposing to eliminate many of the current sanitation requirements and
replace them with this single performance standard for general
sanitation. Examples of current requirements to be replaced by the
general standard are: Secs. 308.3(i) and 381.59, concerning dogs, cats,
and other animals on establishment premises; Sec. 308.8(f), concerning
equipment that generates gases or odors in meat establishments; and
Sec. 381.47 paragraphs (f) and (g), concerning general sanitary
conditions in poultry establishment storage and boiler rooms.
Establishment Grounds and Pest Management--Sec. 416.2(a)
The current requirements for facility grounds are somewhat
prescriptive and inconsistent. For example, Sec. 308.13 requires that
outer premises of every official meat establishment be properly paved
and drained and kept in clean and orderly condition. However, the
counterpart regulation in Sec. 381.56(a) concerning the outside
premises of poultry establishments does not require grounds to be
paved. The proposed performance standard would eliminate this
inconsistency while clarifying and retaining the intent of the current
requirements: that grounds be maintained to prevent conditions that
could lead to the contamination or adulteration of product or prevent
FSIS program employees from performing assigned tasks.
The current requirements for pest control on establishment grounds
and within establishments place much of the responsibility for pest
control on the Agency. For example, Secs. 308.3(h) prohibits the use of
poisons for the control of pests in rooms or compartments where
unpackaged product is stored or handled, unless approved in the
regulations or by the circuit supervisor. Similarly, the regulations in
Sec. 381.60 prohibit the use of pest control substances in poultry
establishments unless approved by the Administrator.
The proposed performance standard preserves the intent of the
current requirement: establishments must implement and maintain an
integrated pest control program to eliminate the harborage and breeding
of pests on the grounds and within the establishment facilities and
must safely and effectively use any interventions, such as pesticides,
fumigants, and rodenticides. The proposed standard would eliminate
requirements that pest control substances be approved by FSIS prior to
use.
Finally, current Sec. 308.3(h) specifically prohibits the use of
``so-called rat viruses'' in meat establishments. FSIS has determined
that this prohibition is obsolete and therefore is proposing to delete
it.
Establishment Construction--416.2(b)
The requirements concerning construction of poultry establishments
are more prescriptive than the comparable requirements for red meat
establishments. For example, Sec. 381.47 prescribes numerous, specific
requirements for the different areas within a poultry establishment,
e.g., refuse rooms, rooms for holding carcasses for further inspection,
coolers and freezers, rooms for mechanical deboning of raw poultry,
storage and supply rooms, boiler rooms, toilet rooms, and lunch rooms.
There are no equally prescriptive requirements in Sec. 308.3 (e), (f),
and (h) of the red meat regulations. The proposed performance standards
in Sec. 416.2(b), which set forth general requirements for construction
applicable to both meat and poultry establishments, would eliminate the
existing inconsistency.
The proposed performance standards allow for increased flexibility
in regard to establishment construction and maintenance. FSIS
recommends that establishments consult the Food and Drug Administration
Food Code when designing, building, or maintaining facilities. The Food
Code provides useful guidance on how to safely process and prepare
food. Although the Food Code is neither federal law nor federal
regulation and does not preempt state or local laws, local, state and
federal regulators use the FDA Food Code as a model to help develop or
update their own food safety rules and to guide the development of a
consistent national food regulatory policy. Similarly, establishment
operators also should consult the various national building and
construction codes and standards. Such materials provide additional
guidance concerning the design, construction, and maintenance of
sanitary meat and poultry establishments.
Also, in a related document published in the Federal Register on
May 2, 1996, FSIS proposed to eliminate current
[[Page 45048]]
requirements for prior approval by FSIS of establishment drawings,
specifications, and equipment prior to their use in official
establishments (FSIS Docket No. 95-032P; 61 FR 19587-19590). These
amendments, like the proposed sanitation performance standards, would
provide the regulated industry with the flexibility to design
facilities and equipment in the manner they deem best to maintain the
required sanitary environment for food production.
Light--416.2(c)
Currently, the lighting requirements for poultry establishments in
Sec. 381.52 prescribe specific light intensities for different areas of
the establishment. For example, in paragraph (b) of this section, FSIS
requires that all rooms in which poultry is killed, eviscerated, or
otherwise processed have 30-foot candles of light intensity on all
working surfaces. The comparable regulations for red meat
establishments in Sec. 308.3(b) do not contain such specific
requirements, stating only that meat establishments must have
``abundant light, of good quality and well distributed.'' Nevertheless,
the intent of the current lighting requirements is the same for both
meat and poultry establishments: there must be enough light of adequate
quality to monitor sanitary conditions and processing operations and to
examine product for evidence of contamination, adulteration, or
misbranding. Proposed Sec. 416.2(c) would codify this intent as a
single performance standard applicable to both meat and poultry
establishments.
FSIS suggests that establishments consult the guidelines for light
intensity contained in the Food Code. The Food Code provides useful
guidance regarding necessary light intensity in food processing
establishments and, in many cases, an establishment in compliance with
the light intensity recommendations in the Food Code would meet the
proposed performance standard for lighting.
It is important to note that FSIS is not proposing to remove from
the current regulations the light intensity requirements for inspector
and reprocessing stations currently set out in Secs. 307.2 and 381.36.
Our experience indicates that these requirements are still necessary to
ensure appropriate conditions for effective inspection. FSIS will
reevaluate these requirements, however, and welcomes comment on the
current requirements and desirable alternatives.
Ventilation--416.2(d)
Currently both the red meat and poultry regulations addressing
ventilation have the same basic requirements: all rooms must be
sufficiently ventilated to eliminate objectionable odors and minimize
moisture condensation, either of which could contaminate or adulterate
product. FSIS is proposing a single performance standard based upon
these current requirements and applicable to both meat and poultry
establishments.
Plumbing--416.2(e)
The design, installation and maintenance of an adequate plumbing
system is a key responsibility of the establishment. Because plumbing
systems carry water into establishments and convey water, sewage, and
other waste from establishments, problems with plumbing systems can
easily cause product contamination or adulteration. The proposed
performance standards would establish the essential condition meat and
poultry establishments must achieve with their plumbing systems:
plumbing systems cannot cause contamination or adulteration of product.
Establishments otherwise would be allowed to build plumbing systems
suitable to the nature and volume of their production. Further, prior
approval requirements in the current plumbing regulations (such as the
requirement in Sec. 308.3(c) that circuit supervisors must preapprove
the traps and vents installed in drains and gutters) would be
eliminated.
FSIS suggests that establishments consult the National Plumbing
Code published by the Building Officials & Code Administrators when
designing or building a plumbing system. The National Plumbing Code is
used by Federal, State, and local governments as a model for their own
plumbing requirements. A plumbing system in compliance with the
National Plumbing Code in most instances would meet the proposed
performance standards for plumbing. Of course, establishments also
should consider State and local plumbing system requirements, as well
as the circumstances of their production, when designing or building a
plumbing system.
Sewage Disposal--416.2(f)
The current requirements for establishment sewage disposal are
unnecessarily prescriptive. For example, Sec. 308.4(c) of the
regulations requires sewage lines to be separate from all other
drainage lines to a point outside the building and not be discharged
into grease catch basins; Sec. 381.49(c)(4) is similar, but allows for
cross-connection if an automatic backwater check valve is installed.
The intent of these requirements is to ensure that sewage does not back
up into processing areas. However, this could be accomplished in other
ways than through separate drainage lines for sewage and house drains.
The proposed performance standard would maintain the requirement that
sewage backup be prevented, but would allow the establishment
flexibility in determining how best to prevent sewage backup.
As with plumbing, FSIS believes that the National Plumbing Code
contains useful guidance for designing and building sewage systems that
would satisfy the proposed regulatory requirements.
Water supply and reuse--416.2(g)
The current requirements regarding water supply and reuse in meat
and poultry establishments (Secs. 308.3(d), 381.50 and 381.53(k)) are
similar, though not identical. In general, both meat and poultry
establishments are required to have water supplies that are ``ample,
clean, and potable, with adequate facilities for its distribution * * *
and protection against contamination and pollution.'' Neither meat nor
poultry establishments may use nonpotable water in areas where edible
product is processed or handled and the use of nonpotable water is
limited to specific areas and equipment. Further, in both meat and
poultry establishments, potable water lines may not be cross-connected
with nonpotable water lines, unless necessary for fire protection and
approved by both FSIS and local authorities.
Restrictions on the reuse of water also are similar for both meat
and poultry establishments. A few permitted ``reuses'' are specified,
one in common for both meat and poultry being the reuse of water to
thermally process canned product packed in hermetically sealed
containers. Any other water reuse must be for the identical original
purpose and must be approved by FSIS.
Finally, both the meat and poultry regulations require that an
adequate supply of hot water be available for cleaning rooms and
equipment.
There are a few differences between the water supply and reuse
regulations for meat and poultry establishments. Under
Sec. 308.3(d)(4), meat establishments are required to have an ample
supply of water of at least 180 deg. F for cleaning equipment, floors,
and walls subject to contamination by diseased meat carcasses. There is
no similar requirement for poultry establishments. Because there are
[[Page 45049]]
substantive and material questions about the efficacy of the 180 deg. F
water for sanitization, the Agency is proposing to eliminate the
requirement (see the discussion below under ``Equipment and Utensils--
416.3'').
Also, under Sec. 381.50(d), FSIS specifically requires that poultry
establishment refuse rooms ``be provided with adequate facilities for
washing refuse cans and other equipment in the rooms.'' There is no
such specific requirement for meat establishments. Finally, under
Sec. 381.50(a), FSIS requires that poultry establishments obtain a
water report issued under the authority of a State health agency,
certifying potability, and furnish this report to FSIS upon request.
Although there is no such regulatory requirement for meat
establishments, FSIS believes that all meat establishments do obtain
such certificates.
Proposed Sec. 416.2(g) consolidates water supply and reuse
requirements for both meat and poultry into a single section. The
proposed performance standards are based on the current regulations, as
well as policies found in FSIS policy documents. Also incorporated are
water reuse performance standards generated over time by industry and
known to be effective in ensuring that the reuse water does not cause
product contamination or adulteration.
Proposed Sec. 416.2(g), paragraph (1), sets forth a water supply
performance standard based upon the general requirements in the current
regulations:
A supply of running water that complies with the National
Primary Drinking Water regulations (40 CFR Part 141), at a suitable
temperature and under pressure as needed, must be provided in all
areas where required (for processing product, for cleaning rooms and
equipment, utensils, and packaging materials, for employee sanitary
facilities, etc.). A water report, issued under the authority of the
State health agency, certifying or attesting to the quality of the
water supply, must be made available to the Agency upon request.
Notably, the proposed standard makes transparent a current requirement
concerning potable water: that it comply with EPA National Primary
Drinking Water regulations. These regulations are promulgated under
Section 1412 of the Public Health Service Act, as amended by the Safe
Drinking Water Act, and are applicable to public water systems. Because
these regulations already apply to potable water used by meat and
poultry establishments, the reference in the proposed performance
standards would not constitute a new requirement.
The proposed performance standard also restates the current
requirement that establishments must make available to FSIS, upon
request, State certificates attesting to water quality. The performance
standard clarifies that this requirement applies to both meat and
poultry establishments. As explained above, while currently there is no
such regulatory requirement for meat establishments, it is likely that
all meat establishments obtain such certificates and also that they
would make them available to FSIS. FSIS believes, therefore, that this
provision would not impose a new requirement upon meat establishments.
Proposed Sec. 416.2, paragraphs (g) (2) through (6) set forth
performance standards for the reuse of water in meat and poultry
establishments. As explained above, the regulations currently permit
water to be reused only under certain circumstances and require that
any other reuse be approved by the Agency in advance. The proposed
performance standards are intended to account for every allowable water
reuse situation and eliminate the need for prior approval.
The meat and poultry industries need great quantities of water for
processing products and for cleaning. Water and water based (aqueous)
solutions are widely used for product formulation, slaughter, cooking,
cooling the equipment, and chilling products as well as for cleaning
and sanitization. Reuse of water and solutions, therefore, can offer
significant economic advantages.
Historically, FSIS and other public health agencies have required
that only potable water be used in the production of meat and poultry
products. However, over the past 20 years the Agency has recognized
that reuse water, which does not meet all of the EPA requirements for
potability, may be used safely and effectively in certain processing
situations. In the early 1990's EPA, FDA, and FSIS representatives
agreed that current technology will allow for the reconditioning of
water for safe and effective reuse in various applications.
Reuse water can be treated to render it free of physical,
microbiological, and chemical hazards. Some of the general treatment
options used include: filtration, chlorination, ozonation, ultraviolet
(UV) radiation, and heating. Use of these procedures can usually return
water to a level of quality appropriate to its intended use. After
treatment, however, such water should be tested regularly to assure
continual freedom from biological, chemical, or physical hazards.
Depending upon the original use, the intended reuse, and the
duration of reuse, a wide range of acceptable microbiological,
chemical, or physical contaminant levels are possible in reuse water.
The previous degree of exposure or potential exposure to contaminants
dictates the appropriate reconditioning treatment and the allowable
reuse. FSIS has based its proposed performance standards for water
reuse on these factors.
Proposed Sec. 416.2(g), paragraph (2) states:
Water used to chill or cook ready-to-eat product may be reused
for the same purpose, provided that measures are taken to ensure
that it is maintained free of pathogenic organisms and fecal
coliform organisms and that other physical, chemical, and
microbiological contamination is reduced so as to prevent
contamination or adulteration of product.
FSIS expects establishments to produce ready-to-eat products that are
free of pathogens; therefore, FSIS is proposing to require that reuse
water used to chill or cook ready-to-eat product be free of pathogens.
FSIS is proposing to require that this reuse water be free of fecal
coliforms because their presence would indicate that the water was
contaminated, possibly with pathogenic organisms. Finally, FSIS is
proposing that other types of contamination be reduced sufficiently to
prevent contamination or adulteration of product.
Paragraph (4) of this proposed section states:
Water used to chill or wash raw product may be reused for the
same purpose provided that measures are taken to reduce physical,
chemical, and microbiological contamination so as to prevent
contamination or adulteration of product. Reuse water which has come
into contact with raw product may not be used on ready-to-eat
product.
FSIS is proposing to require that physical, chemical, and
microbiological contamination be reduced to minimize the risk of cross-
contamination in general. FSIS also is proposing to require that water
used to chill or wash raw product be reused only for the same purpose
to minimize the possibility of cross-contamination between different
types of products or processes. Because raw product often is initially
contaminated with pathogenic microorganisms and fecal coliforms, FSIS
is not proposing to require that this reuse water be free of those
contaminants. Finally, FSIS is proposing to prohibit water which has
come into contact with raw product from being used on ready-to-eat
product so as to prevent the cross-contamination of ready-to-eat
product by contaminants
[[Page 45050]]
or adulterants from raw product. Current regulations mandating the
separation of raw and ready-to-eat product serve the same purpose.
Proposed paragraph (4) applies to meat or poultry establishments
that recondition their water through an advanced wastewater treatment
facility, usually either onsite or under contract. Such water meets the
criteria prescribed in National Primary Drinking Water regulations (40
CFR part 141) concerning water quality. It cannot be considered
``potable,'' however, because it would not originate from the best
available source. The best available source would most often be a
municipal water system.
Because this reconditioned water is of such high quality, FSIS is
proposing to allow it to be used ``on raw product, except in product
formulation, and throughout the facility in edible and inedible
production areas.'' Notably, to prevent establishments from using water
from sewage lines, FSIS would not allow this water to ever have
contained human waste. Further, FSIS is proposing to require that
``product, facilities, and equipment coming in contact with this water
must undergo a separate final rinse with non-reconditioned water that
meets the criteria prescribed in paragraph (g)(1) of this section.''
This requirement, as well as the prohibition against the use of this
water in product formulation, are redundant safeguards, already
accepted by industry. They serve to further prevent contamination or
adulteration of product. It is likely that establishments would use the
reuse water described in this provision to wash equipment, floors, and
carcasses on the kill floor, all of which can easily be rinsed.
Proposed paragraph (5) of this section permits any water to be used
for any purpose in edible or inedible product areas, provided that it
has never contained human waste, has been conditioned to be free of
pathogenic organisms, and does not contact edible product. FSIS is
proposing to require that this reuse water never have contained human
waste to prevent establishments from using water from sewage lines.
FSIS is proposing to require this reuse water to be reconditioned until
free of pathogenic organisms to prevent the spread of pathogenic
organisms throughout an establishment, which could lead to cross-
contamination of product. Finally, because this reuse water may contain
fecal coliforms or chemical or physical contaminants, FSIS is proposing
to prohibit it from contacting edible product.
Finally, proposed paragraph (6) states that any water not meeting
the conditions of Sec. 416.2(g) paragraphs (1) through (5) may not be
used, except in areas where no edible product is handled or prepared
and may not be used in any manner which would allow it to contaminate
or adulterate edible product.
Ice and Solution Reuse--416.2(h)
Similarly, FSIS is proposing to codify performance standards for
ice and solution reuse taken from Agency policy statements (e.g. FSIS
Directive 7110.4, ``Liquid Smoke Re-Use'' and ``MPI Bulletin 83-16,
``Reuse of Water or Brine Cooling Solutions on Product Following a Heat
Treatment'') and accepted industry practices known to ensure that
reused ice or solutions do not contaminate or adulterate product. The
proposed standards for reuse of ice or solutions in Sec. 416.2(h) are
similar to those proposed for water reuse.
The performance standards proposed for reuse of ice or solutions on
ready-to-eat product (Sec. 416.2(h)(3)) serve the same purpose as those
proposed for water reuse on ready-to-eat product (Sec. 416.2(g)(5)).
The proposed performance standards for reuse of ice or solutions on raw
or partially-cooked product (Sec. 416.2(h)(4)) are slightly different
than those proposed for water reuse on raw products (Sec. 416.2(g)(4)).
Unlike the corresponding requirements for water reuse, ice or solutions
from any source may be reused to chill raw or partially-cooked product.
To minimize the possibility of cross-contamination between different
types of products or processes, FSIS is proposing that such ice be free
of fecal coliforms, which indicate contamination.
Dressing Rooms, Lavatories, and Toilets--416.2(i)
Certain current regulations concerning dressing rooms, lavatories,
and toilets in poultry establishments are highly prescriptive. For
example, Sec. 381.51(h) prescribes the exact number of toilet bowls
that should be installed within an establishment based on the number of
people employed, the intent being to ensure that establishments provide
an adequate number of toilet bowls, thus maintaining related sanitary
conditions. The proposed performance standards would give meat and
poultry establishments the responsibility and flexibility to determine
how many dressing rooms, lavatories, and toilets it needs. Of course,
establishments would have to meet any applicable State and local codes
concerning the number of lavatories and toilets in the workplace.
Also, the current regulations for dressing rooms, lavatories, and
toilets include requirements already present in other sections of the
sanitation regulations. For example, ventilation is addressed in
Secs. 308.3(b), 308.4(a), and 308.8(b). The proposed, unified
regulations eliminate such redundancies.
Equipment and Utensils--416.3
The current regulations concerning equipment and utensils are
unduly prescriptive and can deprive establishments of the flexibility
to innovate in regard to equipment and utensil sanitation. The proposed
performance standards not only provide flexibility, but also clarify
establishment responsibility for selecting and maintaining equipment
and utensils in a manner that effectively prevents product
contamination or adulteration:
Equipment and utensils used for processing or otherwise handling
edible product or ingredients must be of such material and
construction to facilitate thorough cleaning and ensure that product
is not contaminated, adulterated, or misbranded during processing,
handling, or storage. Equipment and utensils must be maintained in
sanitary condition so as not to contaminate or adulterate product.
FSIS also is proposing to eliminate Sec. 308.8(c) of the
regulations which requires that all implements used in dressing
diseased meat carcasses be cleaned either with hot water having a
minimum temperature of 180 deg. F or a disinfectant approved by the
Administrator and that they then be rinsed in clean water. This
requirement, and the 180 deg.F water requirement specified in
Sec. 308.3(d)(4), are intended as sanitization steps, effecting a
reduction in microbial levels on areas subject to contamination.
However, research has raised questions about the efficacy of the
180 deg.F requirement. When there is organic matter present on
equipment, such as that which would occur during slaughter or
processing operations at meat or poultry establishments, the length of
time necessary to achieve disinfection can be variable. Additionally,
sometimes disinfection may not be achieved since hot water can bake
organic material onto a surface, impeding the penetration of the water
and diminishing the efficacy of the hot water
disinfection.1, 2
---------------------------------------------------------------------------
\1\ Peel, B., and Simmons, G.C. (1976) Contamination of Knives
as a Means of Spread of Salmonellae in Meatworks. Proceedings of the
Annual Conference of the Australian Veterinary Association, 53: 38-
39.
\2\ Peel, B., and Simmons, G.C. (1978) Factors in the Spread of
Salmonellae in Meatworks with Special Reference to Contamination of
Knives. Australian Veterinary Journal 54: 106-110.
---------------------------------------------------------------------------
[[Page 45051]]
Research also indicates that maintaining the temperature of a water
spray from the nozzle to a surface is quite different from immersion of
utensils in an 180 deg.F water bath. Husband and McPhail 3
studied the specific effects of the use of sprayed 180 deg.F water for
cleaning boning rooms in Australia. Initial measurements of water
temperature along a sprayed stream indicated that water temperature
dropped rapidly with distance from the nozzle. If the initial
temperature at the nozzle was 180 deg.F, the temperatures recorded at
1, 2, and 3 meter points along the water stream were 176 deg.F, 169
deg.F, and 163 deg.F respectively. A maximum temperature of only 127
deg.F was obtained at the boning table surface when water at an initial
nozzle temperature of 180 deg.F was sprayed at a distance of one
meter. Fogging, which results in undesirable condensation, was
subjectively judged to be severe whenever nozzle temperatures exceeded
149 deg.F in a boning room with an initial ambient temperature of 50
deg.F.
---------------------------------------------------------------------------
\3\ Husband, P. And McPhail, N.G. (1978) The Use of 82 deg.C
Water in Meat Plant Cleaning Operations. CSIRO Meat Research Report
No. 2/78. Commonwealth Scientific and Industrial Research
Association.
---------------------------------------------------------------------------
Husband and McPhail 4 also claimed that water at 120
deg.F nozzle temperature was as effective as water at 180 deg.F nozzle
temperature in reducing bacterial numbers on flat uncleaned and
unsanitized surfaces to low levels of 40-75 cfu per 5 cm \2\. These
results were applicable for bacteria originating from meat smears or
from dried-on suspensions of broth cultures. However, they concluded
that rinse water at 131-138 deg.F nozzle temperature is the most
suitable for all stages of an effective cleaning and sanitization
procedure. This conclusion was reached in consideration of the fact
that residual fat is effectively removed, fogging and its resulting
condensation is reduced, and energy is conserved. The authors assert
that bacteriological reduction of at least 5 logs from flat stainless
steel surfaces was expected after effective cleaning and sanitization,
irrespective of rinse water temperature.
---------------------------------------------------------------------------
\4\ Ibid.
---------------------------------------------------------------------------
Attempts to ``disinfect'' with chemical agents or 180 deg.F water
are of limited value unless the surfaces are first thoroughly cleaned
of organic residue such that the bacteria are not protected by film.
Weise and Levitzow 5 demonstrated that cleaning surfaces in
slaughterhouses with just 180 deg.F water caused coagulation of
protein. Protein and fat remained on the examined metal, plastic, and
ceramic tile surfaces. They recommended 165 deg.F water for 30 seconds
to clean, but not disinfect, these surfaces in slaughterhouses.
---------------------------------------------------------------------------
\5\ Weise, E., and Levitzow , R. (1976) Is 82 Degree C the
Optimum Water Temperature for Cleaning Slaughterhouses?
Fleischwirtschaft 56(12): 1725-1728.
---------------------------------------------------------------------------
In the 1970's, the need for energy conservation created interest in
the use of chemical disinfectants in lieu of 180 deg.F water. While
the Environmental Protection Agency (EPA) registers disinfectants under
the Federal Insecticide, Fungicide and Rodenticide Act primarily for
hospital use, there was concern within FSIS about whether such chemical
disinfectants would ensure adequate disinfection of surfaces and
equipment in meat and poultry plants, where pathogens such as
tuberculosis may be present. FSIS developed a program to enable
disinfectant manufacturers to apply for approval of disinfectants and
for meat and poultry plants to apply for use of approved compounds in
lieu of 180 deg.F water. The requirements were published in MPI
Bulletin 77-34 (3-16-77). At this time, there are no disinfectants that
meet the criteria of MPI Bulletin 77-34 and its goals. The EPA does not
have a category of disinfectants specifically for use in meat and
poultry plants. FSIS has since contacted EPA and requested that EPA
identify hospital disinfectant(s) that might be suitable for use in red
meat and poultry plants.
Therefore, because the efficacy of the 180 deg.F water requirement
is questionable, the Agency is proposing to remove the specific
requirements for the water temperature from Sec. 308.8(c) of the
regulations. The proposed performance standard also would replace other
prescriptive sanitation requirements for equipment and utensils, such
as the requirements in Sec. 308.16 concerning electrical stimulating
equipment and the requirements in Sec. 381.53(f) concerning the
construction of ice shovels used in poultry establishments.
FSIS also is proposing that this performance standard replace the
prohibitions against equipment and utensils containing certain
concentrations of liquid polychlorinated biphenyls (PCB's) in
Secs. 308.5(g) and 381.56(b). The new standard would effectively
prohibit the use of any equipment or utensils that could lead to
product contamination by PCB's.
Food-Contact Surface Cleaning and Sanitation--416.4(a)
In general, current Agency policy requires that establishments
clean food contact surfaces daily. However, not all of the pertinent
current meat and poultry regulations state that equipment, utensils,
and rooms be maintained in a sanitary manner. Proposed Sec. 416.4(a)
clarifies and codifies Agency policy regarding daily cleaning:
All food-contact surfaces, including food-contact surfaces of
utensils and equipment, must be cleaned daily prior to starting
operations and as frequently as necessary so that they are free of
physical and chemical contamination and so that microbiological
populations are reduced so as to prevent contamination or
adulteration of product.
This proposed performance standard also clarifies the intent of the
Sanitation SOP regulations in Sec. 416.2(c), which require
establishments to develop and implement SOP's that address the cleaning
of food contact surfaces, equipment, and utensils.
The objective of food-contact surface cleaning requirements has
always been to mitigate physical, chemical, and microbiological
contamination that could contaminate or adulterate product. The
proposed performance standard codifies this objective and clarifies
establishment responsibility for determining how best to achieve it.
Some of the current regulations regarding food-contact surface
cleaning are prescriptive and limit innovation by the establishment.
For example, Sec. 381.58(g) requires that all conveyor trays or belts
which come into contact with raw poultry products be completely washed
and sanitized after each use. The intent of this requirement is to
minimize the growth of microorganisms on the food contact surface.
There may be other more efficient procedures that would accomplish this
objective, however, that are not allowed by the current requirements.
The proposed performance standard would allow establishments to clean
``as frequently as necessary.'' Additionally, the current requirement
in Sec. 381.58(g) is not applicable to cutting boards used for poultry
products, or conveyors and trays used for red meat products. The
proposed performance standard also would remove this inconsistency and
others like it.
Non-Food-Contact Surface Cleaning and Sanitation--416.4(b)
FSIS also is proposing to replace the current regulations
concerning the cleaning and sanitation of non-food-contact surfaces
with a performance standard. For example, Sec. 308.3(d)(4) now requires
that meat establishments use 180 deg.F water for cleaning of floors,
and walls which are subject to contamination by the dressing or
handling of diseased carcasses, their viscera, and other parts. The
intent of
[[Page 45052]]
this regulation is to require establishments to keep floors and walls
free of any physical contaminants (soil, tissue debris), chemical
contaminants or biological contaminants that could contaminate or
adulterate a meat and poultry product. The requirement to prevent
contamination or adulteration is retained in the proposed performance
standard, but without the 180 deg.F water provision. This gives
establishments greater flexibility and responsibility for developing
sanitary procedures specific to the nature of their operations and the
food safety hazards which might occur.
Cleaning Compounds and Sanitizers--416.4(c)
The current regulations in Sec. 381.60 require that FSIS approve
cleaning compounds and sanitizers before they can be used within an
official poultry establishment. FSIS policy has been to enforce this
requirement in meat plants as well. The requirement is intended to
ensure that meat and poultry products are not contaminated or
adulterated with chemicals or any injurious substance. We are proposing
to replace this requirement with a performance standard that would
specify that ``cleaning compounds and sanitizing agents used must be
safe and effective under the conditions of use and their use must not
cause the contamination or adulteration of product.'' Of course,
establishments would still have to meet the use requirements for the
substances promulgated by other regulatory agencies, such as FDA and
EPA.
Operational Sanitation--416.4(d)
The current requirements for operational sanitation (sanitation
measures carried out during operations) are spread throughout a number
of regulations. For example, the requirements concerning rooms and
compartments in which meat product is prepared or handled can be found
in both Secs. 308.3(g) and 308.7. The proposed regulations would
consolidate all of the operational sanitation requirements in a single
place.
Further, certain current requirements for operational sanitation
are unnecessarily prescriptive. For example, current Sec. 381.47(e)
stipulates that rooms where mechanical equipment for deboning of raw
poultry is operated must be maintained at 50 deg.F or less. This
requirement is intended to limit growth of microorganisms resulting
from the rise in temperature of the product as a consequence of the
mechanical grinding operation. Temperatures of 50 deg.F or less slow
the growth rate of most organisms of concern, especially Salmonella.
However, since this requirement was promulgated, FSIS has permitted
many facilities, upon request, to use heat-exchangers connected to the
grinding equipment to bring about an immediate reduction in product
temperature. Heat-exchangers on the equipment can more effectively
reduce product temperature and limit growth of microorganisms than the
requirement to maintain room temperature.
FSIS is proposing to replace the room temperature requirement with
a performance standard that will allow establishments to devise their
own means for limiting microbial growth in their processing operations,
without requesting special approval from the Agency. The proposed
performance standard states that ``Product must be protected from
contamination or adulteration during processing, handling, storage,
loading and unloading at and during transportation from official
establishments'' and that ``ready-to-eat product must be protected from
cross-contamination by pathogenic organisms.''
Under the standard, establishments would be required to protect
meat and poultry products from contamination or adulteration during all
phases of production. Establishments also would be specifically
required to protect ready-to-eat products from cross contamination,
namely by raw product. Establishments would need not only to protect
product from direct contamination, but also to control the temperature
of product in order to reduce microbial growth; in many instances, FSIS
considers microbial growth to be indicative of insanitary conditions.
Establishments would be free to take whatever measures they believe are
necessary, based upon the nature and volume of their production.
Employee Hygiene--416.5(a)
The current regulations mandate specific employee hygiene practices
establishments must adopt. For example, the requirements in
Sec. 308.8(e) specifically prohibit employees from spitting and from
placing ``skewers, tags, or knifes'' into their mouths. Also,
Sec. 381.51(g) states that signs must be posted in each toilet room
directing employees to wash their hands before returning to work. The
proposed performance standard would allow establishments to develop
alternative or innovative means to ensure that employee hygiene
practices do not result in product adulteration or contamination.
Employee Clothing--416.5(b)
Some of the current requirements regarding employee clothing are
prescriptive. For example, Sec. 308.8(d) states that work garments
shall be changed during the day when required by the inspector-in-
charge. The proposed performance standard would require establishments
to develop acceptable policies for prescribing when ``garments must be
changed during the day ... to prevent contamination or adulteration of
product.'' The other requirements of the current regulations, that
garments be made of material that is readily cleaned and that clean
garments be worn at the start of each day, are retained in the proposed
performance standard.
Employee Disease--416.5(c)
The proposed performance standard regarding employee disease is
similar to the current requirements. The revision would serve to
consolidate regulations for meat and poultry into a single section.
Tagging Insanitary Equipment, Rooms, or Compartments--416.6
Similar requirements for the tagging of insanitary equipment,
rooms, or compartments are found in both the meat and poultry
regulations. Tagged equipment, rooms, and compartments tagged cannot be
used until made acceptable. The proposed standard will not change
current FSIS policy, but will consolidate requirements for meat and
poultry into a single section.
FSIS is also proposing to revise Sec. 381.99 of the poultry
regulations. Section 381.99 contains both tagging provisions (which
would be removed and replaced by Sec. 416.6) and descriptions of
different types of tags (which would remain in section 381.99).
Custom Slaughter Establishments
Under current Sec. 303.1(a)(2)(i), establishments that conduct
custom slaughter operations must meet all of the sanitation
requirements contained in Part 308, with a few exceptions. Custom
slaughter establishments currently are exempt from the following:
Secs. 308.1 and 308.2--prior approval requirements for
sanitary conditions, drawings, and blueprints;
Sec. 308.3(d) (2) and (3)--water reuse restrictions;
Sec. 308.4--provisions requiring that establishments have
separate toilet facilities for men and women (if a majority of the
custom slaughter establishment's employees are related by blood or
marriage and if this arrangement will not conflict with municipal or
State requirements) and
[[Page 45053]]
provisions requiring that toilet soil lines be separate from house
drainage lines to a point outside the buildings (if positive acting
backflow devices are installed);
Sec. 308.12--restrictions regarding the use of second-hand
tubs, barrels, and other containers;
Sec. 308.13--provisions requiring that driveways,
approaches, yards, pens, and alleys be paved;
Sec. 308.16--sanitation requirements for electrical
stimulating equipment; and
any provisions of Part 308 relating to inspection or
supervision of specified activities or other action by a Program
employee.
FSIS is proposing to retain the exemptions in 303.1(a)(2)(i), but
also to modify them for consistency with the proposed sanitation
performance standards in new Part 416. FSIS is proposing to eliminate
the requirements in Sec. 308.1 regarding examination of sanitary
conditions prior to inauguration of inspection; the requirements in
Sec. 308.4 regarding separation of toilet lines; the requirements in
Sec. 308.12 regarding the use of second-hand tubs, barrels, and other
containers; the requirements in Sec. 308.13 regarding surface paving;
and the requirements in Sec. 308.16 regarding the sanitation of
electrical stimulating equipment. Therefore, the revised 303.1(a)(2)(i)
would not refer to exemptions from these requirements. Similarly, in a
recent proposal (FSIS Docket No. 95-032P; 61 FR 19587-19590), FSIS
eliminated the requirements in Sec. 308.2 concerning prior approval of
establishment blueprints and drawings. The revised 303.1(a)(2)(i)
therefore would not include an exemption from these requirements
either.
Additional Regulatory and Policy Revisions
The comprehensive nature of this proposed rule would necessitate
many changes to FSIS policy documents and regulatory references. FSIS
will complete all of the needed revisions prior to the effective date
of any final rule emanating from this rulemaking.
These changes fall into two categories. First, FSIS would need to
revise all of the cross-references in the meat and poultry regulations
to reflect the proposed deletion of Secs. 308 and 381 Subpart H and the
proposed addition of new Secs. 416.1 through 416.6. These revisions
would be nonsubstantive. Second, FSIS plans to rescind or revise many
sanitation issuances and directives inconsistent with the proposed rule
and with HACCP.
Much of the material contained in the rescinded or revised
issuances and directives would be re-formatted and published as
guidance materials providing information, advice, and suggestions on
how the proposed performance standards can be met. For example, the
contents of MPI Bulletin 83-16 (Re-Use of Water or Brine Cooking
Solution on Product Following a Heat Treatment) will remain available
from the Agency as guidance material for establishments to use in
addressing the proposed performance standards.
Some of the material has been used to develop performance standards
FSIS is proposing or plans to propose. For instance, material from FSIS
Directive 7110.4 (Liquid Smoke Re-Use) was used to develop the proposed
performance standard for solution re-use.
Issuances To Be Rescinded by the Agency
FSIS would rescind the following directives and issuances prior to
the finalization of this proposal:
Approved Water Systems Guide
FSIS Directive 7110.4--Liquid Smoke Re-Use
FSIS Directive 11,100.1--Sanitation Handbook
FSIS Directive 11,000.2--Plant Sanitation
FSIS Directive 11,000.4--Paints and Coatings in Official Establishments
FSIS Directive 11,210.1--Protecting Potable Water Supplies on Official
Premises
FSIS Directive 11,220.2--Guidelines for Sanitization of Automatic
Poultry Eviscerating Equipment
FSIS Directive 11,240.5--Plastic Cone Deboning Conveyors
FSIS Directive 11,520.2--Exposed Heat-Processed Products; Employee
Dress
FSIS Directive 11,520.4--Strip Doors in Official Establishments
FSIS Directive 11,540.1--Use of Certain Vehicles as
Refrigeration or Dry Storage Facilities
MPI Bulletin 77-34--Chemical Disinfection in Lieu of 180 deg. F Water
MPI Bulletin 77-129--Water Conservation and Sanitation
MPI Bulletin 79-68--Use of Iodine in Processing Water
MPI Bulletin 81-38--Equipment and Procedure Requirements for Processing
Gizzards
MPI Bulletin 83-14--Monitoring Chlorine Concentration in
Official Establishments
MPI Bulletin 83-16--Re-Use of Water or Brine Cooking Solution on
Product Following a Heat Treatment
Executive Order 12866 and Regulatory Flexibility Act
This proposed rule has been reviewed under Executive Order 12866.
The rule has been determined to be significant for the purposes of
Executive Order 12866 and, therefore, has been reviewed by the Office
of Management and Budget.
In accordance with 5 U.S.C. 603, FSIS has performed an Initial
Regulatory Flexibility Analysis, which is set out below, regarding the
impact of this rule on small entities. However, FSIS does not currently
have all the data necessary for a comprehensive analysis of the effects
of this rule on small entities. Therefore, FSIS is inviting comments
concerning potential effects. In particular, FSIS is interested in
determining the number and kind of small entities that may incur
benefits or costs from implementation of this proposed rule.
FSIS is proposing to revise and consolidate the sanitation
regulations for meat and poultry establishments, resolve unnecessary
differences between similar requirements for meat and poultry, and
convert prescriptive requirements to performance standards. This
proposal would affect meat and poultry establishments subject to
official inspection, custom exempt red meat establishments, and
consumers.
In general, the proposed streamlining, clarification, and
consolidation of the sanitation regulations should benefit FSIS, the
regulated industry, and consumers. User-friendly regulations would
simplify compliance and therefore could bring about food safety
enhancements in individual establishments. Further, consolidation of
the separate sanitation requirements for meat and poultry products and
the consequent elimination of unnecessary inconsistencies could enhance
competition.
This proposed rule would allow individual establishments to develop
and implement customized sanitation procedures other than those
currently mandated, as long as those procedures produced sanitary
conditions meeting the proposed performance standards. Establishments
taking advantage of the performance standards to innovate thus could
benefit from savings accrued through increased efficiency. However,
since the currently mandated sanitation procedures meet the proposed
performance standards, establishments lacking the resources to innovate
could choose to continue employing current procedures. Such
establishments should incur no additional expenses as a result of this
rule. FSIS therefore anticipates
[[Page 45054]]
that sanitation performance standards would have a generally favorable
economic impact on all establishments, regardless of size.
It is difficult to quantify the potential benefits of the proposed
performance standards since it is not possible to predict exactly how
many establishments would develop innovative processes and how these
innovations reduce. However, FSIS sees the potential for an increase in
the efficiency of the nation's economy in general because the proposed
performance standards would stimulate innovation and encourage
businesses to consider a more efficient use of resources. Also, the
possibility of subsequently reduced prices of meat or poultry products
are economic factors that could produce a more efficient use of
resources in the economy as a whole. These effects would be small for
individual firms and consumers, but could be substantial in the
aggregate.
Finally, FSIS is restructuring inspection activities to focus more
attention on the ability of establishments to maintain a sanitary
environment through implementation of the new Sanitation SOP
requirements. This proposal is part of that initiative and is intended
to reduce demands on FSIS resources which could be redirected to
functions more critical to improving food safety. FSIS anticipates that
this proposal, along with the HACCP, Sanitation SOP, and other food
safety initiatives, would produce significant economic and societal
benefits by reducing the incidence of foodborne illness.
As an alternative to the present proposal, the Agency considered
proposing more comprehensive and prescriptive sanitation regulations.
The proposed requirements would then have included very specific
definitions of terms, such as definitions for food contact surfaces or
premises; more prescriptive performance standards than those proposed,
such as microbial criteria for recently cleaned and sanitized food
contact surfaces; detailed requirements currently contained in Agency
guidance materials, such as an ambient temperature requirement for
rooms in which certain processes are conducted; and a list of specific
regulatory prohibitions, again largely drawn from existing regulatory
and guidance material.
The Agency did not choose this more detailed and prescriptive
alternative, due to the unnecessarily restrictive burden it would place
on industry, and has made tentative decisions in these areas, on which
it specifically requests comments. On the matter of definitions, the
Agency has determined that within the food processing community and the
meat and poultry processing industry there is an understanding of
descriptive terms such as ``food contact surfaces'' and ``premises,''
and that to construct a technically accurate definition which
encompassed all the possible meat and poultry establishment situations
in which the term could be applied was neither useful nor likely to
succeed. The Agency notes, however, that these and other terms are
defined in both the Food Code and in certain FDA regulations and
specifically requests comment on whether those definitions ought to be
referenced in FSIS regulations.
Similarly, the Agency has made a tentative decision that a
proliferation of prescriptive standards applicable to the establishment
environment or its features, like ambient temperature or microbial
characteristics of cleaned equipment, would not be a useful addition to
the proposed standards, which are based on the general requirement that
establishments prevent product contamination or adulteration. At
various other places in its regulations, the Agency has established
performance standards applicable to meat and poultry products. The
newest is the Salmonella performance standard for raw carcasses and
ground product established in the Pathogen Reduction/HACCP final
regulation. Another is the zero tolerance standard for fecal material
on raw carcasses. Others include the prohibition on violative levels of
chemical residues and the policy that there be no Listeria or
Salmonella on certain ready-to-eat products. Achieving these product-
based performance standards depends on an establishment doing a number
of things correctly, including correctly carrying out the sanitation
responsibilities set forth in part 416.1 through 416.6. FSIS has
tentatively concluded that because there are many methods and means
through which establishments can ensure that product is not
contaminated or adulterated, FSIS will not prescribe exactly which
methods, procedures, or means must be used. FSIS requests comment on
this tentative decision.
FSIS is carefully reviewing its guidance material on sanitation in
an effort to develop the most comprehensive possible set of approaches
which can be considered by establishments as they determine how they
will go about meeting the performance standards. If that reviews yields
provisions which should become parts of the performance standards, FSIS
will revise its regulations accordingly. If the review yields a number
of possible approaches which could be used by an establishment, they
will all be included in guidance material, which FSIS expects to
complete by the time this proposal is made final.
Finally, on the issue of whether there should be a list of specific
prohibited practices retained in the regulations, FSIS has made a
tentative decision that this is not necessary and could be misleading.
Most of the prohibited practices which are mentioned in the current
sanitation regulations represent only one or a small fraction of the
ways in which establishments could fail to meet a performance standard.
For example, using burlap as a wrap directly applied to the surface of
meat is only one of the means by which an establishment could be
failing to prevent direct product contamination. Preventing direct
product contamination is the performance standard. It encompasses a
prohibition on using burlap as a wrap, as well as a large number of
other practices. The Agency believes that a partial or outdated list of
regulatory prohibitions may suggest that anything not on the list is
not prohibited. FSIS prefers to communicate about unsuitable practices
through its guidance material, while holding establishments directly
responsible for meeting concisely defined performance standards which
mitigate against a wide range of unsuitable practices.
The other alternative available to FSIS was to maintain the current
sanitation requirements. However, as explained in detail above, the
current requirements are to an extent inconsistent with the principles
of HACCP, can impede innovation, and often can lead to confusion about
FSIS and establishment responsibilities for food safety.
Executive Order 12778
This proposed rule has been reviewed under Executive Order 12778,
Civil Justice Reform. States and local jurisdictions are preempted by
the Federal Meat Inspection Act and the Poultry Products Inspection Act
(PPIA) from imposing any marking, labeling, packaging, or ingredient
requirements on federally inspected meat and poultry products that are
in addition to, or different than, those imposed under the FMIA or the
PPIA. States and local jurisdictions may, however, exercise concurrent
jurisdiction over meat and poultry products that are outside official
establishments for the purpose of preventing the distribution of meat
and poultry products that are misbranded or adulterated under the FMIA
or PPIA, or, in the case of imported articles, which
[[Page 45055]]
are not at such an establishment, after their entry into the United
States.
This proposed rule is not intended to have retroactive effect.
If this proposed rule is adopted, administrative proceedings will
not be required before parties may file suit in court challenging this
rule. However, the administrative procedures specified in 9 CFR
Secs. 306.5 and 381.35 must be exhausted prior to any judicial
challenge of the application of the provisions of this proposed rule,
if the challenge involves any decision of an FSIS employee relating to
inspection services provided under the FMIA or the PPIA.
Executive Order 12898
Pursuant to Executive Order 12898 (59 FR 7629, February 16, 1994),
``Federal Actions to Address Environmental Justice in Minority
Populations and Low-Income Populations,'' FSIS has considered potential
impacts of this proposed rule on environmental and health conditions in
low-income and minority communities.
This proposed rule would consolidate the sanitation regulations for
meat and poultry establishments into a single part, eliminate
unnecessary differences between the meat and poultry sanitation
requirements, and convert many of the highly prescriptive requirements
to performance standards. As explained in the economic impact analysis
above, the proposed regulations should generally benefit FSIS, the
regulated industry, and consumers. The proposed regulations would not
require or compel meat or poultry establishments to relocate or alter
their operations in ways that could adversely affect the public health
or environment in low-income and minority communities. Further, this
proposed rule would not exclude any persons or populations from
participation in FSIS programs, deny any persons or populations the
benefits of FSIS programs, or subject any persons or populations to
discrimination because of their race, color, or national origin.
Paperwork Requirements
Abstract: FSIS has reviewed the paperwork and recordkeeping
requirements in this proposed rule in accordance with the Paperwork
Reduction Act.
Under the current regulations, if meat and poultry establishments
are cited for rodent or vermin infestation, FSIS requires
establishments to develop a written corrective action report. The
Office of Management and Budget (OMB) under control number O583-0082,
``Meat and Poultry Inspection and Application for Inspection,'' has
approved 351 burden hours for this activity.
This proposed rule would eliminate the requirement that
establishments develop rodent and vermin infestation corrective action
reports. Corrective action measures for rodent and vermin infestation
will be part of establishments' Sanitation SOP's. The burden hours
reported for Sanitation SOP's includes the development of these
corrective actions. Therefore, FSIS would request OMB to remove the 351
burden hours approved for the development of rodent and vermin
infestation corrective action reports.
Also, proposed Sec. 416.2(g)(1) requires that establishments, upon
request, make available to FSIS ``water reports issued under the
authority of the State health agency certifying or attesting to the
quality of the water supply.'' This paperwork collection requirement
already is in place under the current regulations and is approved under
OMB control number O583-0082, ``Meat and Poultry Inspection and
Application for Inspection.''
Copies of this information collection assessment can be obtained
from Lee Puricelli, Paperwork Specialist, Food Safety and Inspection
Service, USDA, South Agriculture Building, Room 3812, Washington, DC
20250.
Comments are invited on: (a) whether the proposed collection of
information is necessary for the proper performance of the functions of
the Agency, including whether the information will have practical
utility; (b) the accuracy of the Agency's estimate of the burden of the
proposed collection of information including the validity of the
methodology and assumptions used; (c) ways to enhance the quality,
utility, and clarity of the information to be collected; and (d) ways
to minimize the burden of the collection of information on those who
are to respond, including through the use of appropriate automated,
electronic, mechanical, or other technological collection techniques or
other forms of information technology. Comments may be sent to Lee
Puricelli, Paperwork Specialist, see address above, and Desk Officer
for Agriculture, Office of Information and Regulatory Affairs, Office
of Management and Budget, Washington, DC 20253.
Comments are requested by October 24, 1997. To be most effective,
comments should be sent to OMB within 30 days of the publication date
of this proposed rule.
List of Subjects
9 CFR Part 303
Meat inspection, Reporting and recordkeeping requirements.
9 CFR Part 308
Meat inspection.
9 CFR Part 381
Poultry and poultry products inspection, Reporting and
recordkeeping requirements.
9 CFR Part 416
Sanitation.
Accordingly, title 9, chapter III, of the Code of Federal
Regulations would be amended as follows:
PART 303--EXEMPTIONS
1. The authority citation for part 303 would continue to read as
follows:
Authority: 21 U.S.C. 601-695; 7 CFR 2.17, 2.55.
2. Section 303.1 would be amended by revising paragraph (a)(2)(i)
to read as follows:
Sec. 303.1 Exemptions.
(a) * * *
(2) * * *
(i) Establishments conducting custom slaughter operations must be
maintained and operated in accordance with the provisions of part 416
except for: Secs. 416.2(g) (1) through (7), regarding water reuse; the
provision in Sec. 416.2(i) requiring that separate toilet facilities be
provided where both sexes are employed (if the majority of the workers
in the custom slaughter establishment are related by blood or marriage
and this arrangement will not conflict with municipal or State
requirements); and any provisions of part 416 relating to inspection or
supervision of specified activities or other action by a Program
employee. If custom operations are conducted in an official
establishment, however, all of the provisions of Part 416 shall apply
to those operations.
* * * * *
PART 308--[REMOVED]
3.-4. Part 308 would be removed.
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS
5. The authority citation for part 381 would continue to read as
follows:
Authority: 7 U.S.C. 138f; 7 U.S.C. 450, 21 U.S.C. 451-470; 7
U.S.C. 2.18, 2.53.
Subpart H--[Removed]
6. Subpart H would be removed.
[[Page 45056]]
7. Section 381.99 would be revised to read as follows:
Sec. 381.99 Official retention and rejection tags.
The official marks for use in post-mortem inspection and
identification of adulterated products, insanitary equipment and
facilities are:
(a) A paper tag (a portion of Form MP-35) bearing the legend ``U.S.
Retained'' for use on poultry or poultry products under this section.
(b) A paper tag (another portion of Form C&MS 510) bearing the
legend ``U.S. Rejected'' for use on equipment, utensils, rooms and
compartments under this section.
PART 416--SANITATION
8. The authority citation for part 416 would continue to read as
follows:
Authority: 21 U.S.C. 451-470, 601-680; 7 U.S.C. 450; 7 CFR 2.18,
2.53.
9. Part 416 would be amended by adding new Secs. 416.1 through
416.6, to read as follows:
Sec. 416.1 General rules.
Each official establishment must be operated and maintained in a
sanitary manner sufficient to ensure that product is not contaminated,
adulterated, or misbranded.
Sec. 416.2 Establishment grounds and facilities.
(a) Grounds and pest control. The grounds about an establishment
must be maintained to prevent conditions that could lead to
contamination or adulteration of product or that could prevent FSIS
programs employees from performing assigned tasks. Establishments must
have in place an integrated pest management program to prevent the
harborage and breeding of pests on the grounds and within establishment
facilities. Pest control substances used must be safe and effective
under the conditions of use and not result in the contamination or
adulteration of product.
(b) Construction. (1) Establishment buildings, including their
structures, rooms, and compartments must be of sound construction, kept
in good repair, and be of sufficient size to allow for the sanitary
processing, handling, and storage of product.
(2) Walls, floors, and ceilings within establishments must be built
of durable materials impervious to moisture and be cleaned, maintained,
and sanitized when necessary to prevent contamination or adulteration
of product.
(3) Walls, floors, ceilings, doors, windows, and other outside
openings must be constructed and maintained to prevent the entrance of
vermin, such as flies, rats, and mice.
(4) Rooms or compartments in which edible product is processed,
handled, or stored must be separate and distinct from rooms or
compartments in which inedible product is processed, handled, or
stored.
(c) Light. Lighting of good quality and sufficient intensity to
ensure that sanitary conditions are maintained and that product is not
contaminated, adulterated or misbranded must be provided in areas where
food is processed, handled, stored, or examined, where equipment and
utensils are cleaned, and in hand-washing areas, dressing and locker
rooms, and toilets.
(d) Ventilation. Ventilation adequate to eliminate odors, vapors,
and condensation must be provided to prevent contamination or
adulteration of product and to ensure that FSIS programs employees can
perform assigned tasks.
(e) Plumbing. Plumbing systems must be installed and maintained to:
(1) Carry sufficient quantities of water to required locations
throughout the establishment;
(2) Properly convey sewage and liquid disposable waste from the
establishment;
(3) Prevent contamination or adulteration of product, water
supplies, equipment, or utensils, and maintain sanitary conditions
throughout the establishment;
(4) Provide adequate floor drainage in all areas where floors are
subject to flooding-type cleaning or where normal operations release or
discharge water or other liquid waste on the floor; and
(5) Prevent back-flow conditions in and cross-connection between
piping systems that discharge waste water or sewage and piping systems
that carry water for product manufacturing;
(6) Prevent the backup of sewer gases.
(f) Sewage disposal. Sewage must be disposed into a sewage system
separate from all other drainage lines or disposed of through other
means sufficient to prevent backup of sewage into areas where product
is processed, handled, or stored. When the sewage disposal system is a
private system requiring approval by a State or local health authority,
the establishment must be able to furnish FSIS with the letter of
approval from that authority upon request.
(g) Water supply and reuse. (1) A supply of running water that
complies with the National Primary Drinking Water regulations (40 CFR
Part 141), at a suitable temperature and under pressure as needed, must
be provided in all areas where required (for processing product, for
cleaning rooms and equipment, utensils, and packaging materials, for
employee sanitary facilities, etc.). A water report, issued under the
authority of the State health agency, certifying or attesting to the
quality of the water supply, must be made available to the Agency upon
request.
(2) Water used to chill or cook ready-to-eat product may be reused
for the same purpose, provided that measures are taken to ensure that
it is maintained free of pathogenic organisms and fecal coliform
organisms and that other physical, chemical, and microbiological
contamination is reduced so as to prevent contamination or adulteration
of product.
(3) Water used to chill or wash raw product may be reused for the
same purpose provided that measures are taken to reduce physical,
chemical, and microbiological contamination so as to prevent
contamination or adulteration of product. Reuse water which has come
into contact with raw product may not be used on ready-to-eat product.
(4) Reconditioned water that has never contained human waste and
which has been treated by an onsite advanced wastewater treatment
facility may be used on raw product, except in product formulation, and
throughout the facility in edible and inedible production areas,
provided that measures are taken to assure that this water meets the
criteria prescribed in paragraph (g)(1) of this section. Product,
facilities, equipment, and utensils coming in contact with this water
must undergo a separate final rinse with non-reconditioned water that
meets the criteria prescribed in paragraph (g)(1) of this section.
(5) Any water that has never contained human waste and is free of
pathogenic organisms may be used in edible and inedible product areas,
provided it does not contact edible product. For example, such reuse
water may be used to move heavy solids, flush the bottom of open
evisceration troughs, or to wash antemortem areas, livestock pens,
trucks, poultry cages, picker aprons, picking room floors, and similar
areas within the establishment.
(6) Water which does not meet the use conditions of paragraphs
(g)(1) through (g)(5) of this section, may not be used in areas where
edible product is handled or prepared or in any manner which would
allow it to contaminate or adulterate edible product.
(h) Ice and solution reuse. (1) Ice used or reused must have been
originally produced from water meeting the
[[Page 45057]]
requirements of paragraphs (g)(1) of this section.
(2) Ice used on raw product may not be reused on ready-to-eat
product.
(3) Ice or solutions (such as brine, liquid smoke, or propylene
glycol) may be reused on ready-to-eat product if they are free of
pathogenic and fecal coliforms and if other physical, chemical, and
microbiological contamination has been reduced so as to prevent the
contamination or adulteration of product.
(4) Ice or solutions may be reused on raw and partially-cooked
product if they are free of fecal coliforms and if other physical,
chemical and microbiological contamination has been reduced so as to
prevent the adulteration of product.
(i) Dressing rooms, lavatories, and toilets. (1) Dressing rooms,
toilet rooms, and urinals must be sufficient in number, ample in size,
conveniently located, and maintained in a sanitary condition and in
good repair at all times to ensure cleanliness of all persons handling
any product. They must be separate from the rooms and compartments in
which products are processed, stored, or handled. Where both sexes are
employed, separate facilities must be provided.
(2) Lavatories with running hot and cold water, soap, and towels,
must be placed in or near toilet and urinal rooms and at such other
places in the establishment as necessary to ensure cleanliness of all
persons handling any product.
(3) Refuse receptacles constructed and maintained in a manner that
protects against contamination or adulteration of food must be
provided.
Sec. 416.3 Equipment and utensils.
(a) Equipment and utensils used for processing or otherwise
handling edible product or ingredient must be of such material and
construction to facilitate thorough cleaning and ensure that product is
not contaminated, adulterated, or misbranded during processing,
handling, or storage. Equipment and utensils must be maintained in
sanitary condition so as not to contaminate or adulterate product.
(b) Equipment and utensils must not interfere with inspection
procedures or prevent FSIS programs employees from performing assigned
tasks.
(c) Receptacles used for storing inedible material must be of such
material and construction that their use will not result in
contamination or adulteration of any edible product or in insanitary
conditions at the establishment. They must not be used for storing any
edible product and must bear conspicuous and distinctive marking to
identify permitted uses.
Sec. 416.4 Sanitary operations.
(a) All food-contact surfaces, including food-contact surfaces of
utensils and equipment, must be cleaned daily prior to starting
operations and as frequently as necessary so that they are free of
physical and chemical contamination and so that microbiological
populations are reduced so as to prevent contamination or adulteration
of product.
(b) Non-food-contact surfaces of facilities, equipment, and
utensils used in the operation of the establishment must be cleaned as
frequently as necessary to prevent the physical, chemical, or
biological contamination or adulteration of product.
(c) Cleaning compounds and sanitizing agents used must be safe and
effective under the conditions of use and their use must not cause the
contamination or adulteration of product.
(d) Product must be protected from contamination or adulteration
during processing, handling, storage, loading, and unloading at and
during transportation from official establishments; ready-to-eat
product must be protected from cross-contamination by pathogenic
organisms.
Sec. 416.5 Employee hygiene.
(a) Cleanliness. All persons working in contact with product, food-
contact surfaces, and product-packaging materials must adhere to
hygienic practices while on duty to prevent contamination or
adulteration of product.
(b) Clothing. Aprons, frocks, and other outer clothing worn by
persons who handle product must be of material that is readily cleaned.
Clean garments must be worn at the start of each working day and
garments must be changed during the day as often as necessary to
prevent contamination or adulteration of product.
(c) Disease control. Any person who has or appears to have an
illness, open lesion, including boils, sores, or infected wounds, or
any other abnormal source of microbial contamination must be excluded
from any operations which could result in product contamination or
adulteration until the condition is corrected.
Sec. 416.6 Tagging insanitary equipment, utensils, rooms or
compartments.
When a Program employee finds that any equipment, utensil, room, or
compartment at an official establishment is unclean or that its use
would be in violation of any of the regulations in this subchapter, he
will attach to it a ``U.S. Rejected'' tag. Equipment, utensils, rooms,
or compartments so tagged cannot be used until made acceptable. Only a
Program employee may remove a ``U.S. Rejected'' tag.
Done in Washington, DC on: August 11, 1997.
Thomas J. Billy,
Administrator.
[FR Doc. 97-21881 Filed 8-22-97; 8:45 am]
BILLING CODE 3410-DM-P
