[Federal Register Volume 64, Number 202 (Wednesday, October 20, 1999)]
[Rules and Regulations]
[Pages 56400-56418]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-26983]


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DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Parts 303, 304, 307, 308, 312, 314, 327, 331, 350, 381, and 
416

[Docket No. 96-037F]


Sanitation Requirements for Official Meat and Poultry 
Establishments

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Final rule.

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SUMMARY: The Food Safety and Inspection Service (FSIS) is revising its 
regulatory requirements concerning sanitation in official meat and 
poultry establishments. Specifically, FSIS is consolidating the 
sanitation regulations into a single part applicable to both official 
meat and poultry establishments, eliminating unnecessary differences 
between the sanitation requirements for meat and poultry processing, 
and converting many of the highly prescriptive sanitation requirements 
to performance standards.

EFFECTIVE DATES: January 25, 2000.

FOR FURTHER INFORMATION CONTACT: Daniel L. Engeljohn, Ph.D., Director, 
Regulation Development and Analysis Division, Office of Policy, Program 
Development, and Evaluation, Food Safety and Inspection Service, U.S. 
Department of Agriculture (202) 720-5627.

SUPPLEMENTARY INFORMATION:

Background

    As a result of a recent, comprehensive review of its regulatory 
procedures and

[[Page 56401]]

requirements, FSIS identified the need to revise its sanitation 
requirements for official meat and poultry establishments. The Agency's 
tentative view was that a number of the sanitation requirements were 
difficult to understand, redundant, or outdated. Also, the Agency found 
that there were unnecessary differences between the sanitation 
regulations for official meat and poultry establishments. Finally, the 
Agency could not justify the retention of the sanitation regulations 
that were inconsistent with the Agency's recently finalized Hazard 
Analysis and Critical Control Point (HACCP) and Sanitation Standard 
Operating Procedure (Sanitation SOP) regulations. These sanitation 
requirements were unnecessarily prescriptive, impeded innovation, and 
blurred the distinction between establishment and inspection program 
employee responsibilities for maintaining sanitary conditions.
    Therefore, on August 25, 1997, FSIS published in the Federal 
Register a proposal to revise its sanitation requirements for official 
meat and poultry establishments (62 FR 45045). FSIS proposed to 
consolidate the sanitation regulations into a single part applicable to 
both official meat and poultry establishments, eliminate unnecessary 
differences between the meat and poultry sanitation requirements, and 
convert many of the highly prescriptive sanitation requirements into 
performance standards. FSIS initially solicited comment on the proposal 
for a 60-day period ending October 24, 1997.
    Shortly after the comment period for that proposal opened, FSIS 
mistakenly released information that mischaracterized the provisions of 
the proposal concerning the use of nonfood compounds and proprietary 
substances. In order to alleviate any confusion regarding the 
sanitation proposal and to clarify FSIS policy in regard to nonfood 
compounds and proprietary substances, FSIS published a retraction of 
the erroneous information in the Federal Register (FSIS Docket No. 97-
062N; 62 FR 55996). Further, in order to ensure that the public had 
ample opportunity to submit meaningful comments on the sanitation 
proposal and its provisions concerning nonfood compounds and 
proprietary substances, FSIS reopened the comment period for that 
proposal for 15 days, from October 28, 1997, to November 10, 1997 (FSIS 
Docket 96-037R; 62 FR 55997).
    By the close of the second comment period, FSIS had received 51 
comments from meat and poultry establishments, trade and professional 
associations, academia, consumer advocacy groups, State governments, 
and FSIS inspection program employees. Two of these comments included 
requests for a 90-day extension of the original comment period. FSIS 
believed the original 60-day comment period was sufficient and did not 
extend it, except for the 15-day period discussed above.
    About two-thirds of the commenters opposed the proposal in general. 
Many of these commenters characterized the proposal as ``deregulation'' 
that would weaken inspection program employee authority and reduce the 
consumer food safety protections in the existing prescriptive 
regulations. Most of these commenters argued that there should be no, 
or only minimal, change to the existing sanitation regulations.
    The other third of the commenters generally supported the proposal 
to revise the sanitation requirements for official meat and poultry 
establishments. These commenters commended FSIS efforts to streamline 
and consolidate the sanitation requirements, to make the requirements 
consistent with the HACCP and Sanitation SOP regulations, and to grant 
establishments greater flexibility to innovate. Many of these 
commenters, however, did raise objections to and recommend revisions 
for specific provisions in the proposed rule.
    FSIS responses to all of the relevant comments follow.

General Opposition

    Comment: Many of the commenters opposed to the proposal 
characterized the performance standards as ``deregulation'' that would 
weaken FSIS enforcement authority and endanger consumers. Some of these 
commenters maintained that the proposed performance standards are too 
general to be enforceable, as they would allow for multiple 
interpretations of the sanitation standards. Several commenters also 
argued that by replacing with performance standards the existing 
sanitation requirements that contain prohibitions against specific 
activities, such as the prohibition in Sec. 308.8(e) against ``placing 
skewers, tags, or knives in the mouth,'' FSIS would be impairing 
inspection program employees' ability to take action as necessary to 
prevent product adulteration.
    Response: The sanitation performance standards are ``deregulatory'' 
in the sense that they remove obstacles to innovation previously caused 
by overly prescriptive, and in some cases obsolete, sanitation 
regulations. For establishments to fully and successfully meet the 
HACCP and Sanitation SOP requirements, they must be able to innovate, 
or at least customize their operating procedures, to control food 
safety hazards and ensure that product does not become adulterated 
within their unique processing environments. The sanitation performance 
standards established in this rule not only will provide meat and 
poultry establishments with the flexibility to innovate in facility 
design, construction, and operations, but also will articulate the 
standards for good sanitation and for food product safety that must be 
met by establishments.
    The sanitation performance standards are not subject to multiple 
interpretations. Regardless of the area or activity any individual 
performance standard governs, all of the sanitation standards have the 
same intent: An official meat or poultry establishment must operate 
under sanitary conditions, in a manner that ensures that product is not 
adulterated and that does not interfere with FSIS inspection and its 
enforcement of such standards. However, because the sanitation 
performance standards define the results to be achieved by sanitation, 
but not the specific means to achieve those results, the sanitation 
performance standards can be met by establishments in different ways. 
Regardless of the means by which establishments comply with the 
standards, the required results will be the same for all 
establishments.
    The sanitation performance standards do not lessen the authority of 
FSIS inspection program employees nor in any way weaken the statutory 
and regulatory requirements that official meat and poultry 
establishments maintain sanitary conditions and ensure that product is 
not adulterated. Section 8 of the Federal Meat Inspection Act (FMIA) 
states that the ``Secretary shall cause to be made by experts in 
sanitation or other competent inspectors, such inspection * * * as may 
be necessary to inform himself of the sanitary conditions* * * of * * 
*establishments.'' It also provides that ``where the sanitary 
conditions of any such establishment are such that the meat or meat 
food products are rendered adulterated, (the Secretary of Agriculture) 
shall refuse to allow said meat or meat food products to be labeled, 
marked, stamped, or tagged as `inspected and passed.' '' Likewise 
section 7 of the Poultry Products Inspection Act (PPIA) requires that 
every official poultry establishment subject to inspection be operated 
according to sanitary practices ``required by regulations promulgated 
by the Secretary (of Agriculture) for the purpose of preventing the 
entry into * * * commerce * * * of poultry

[[Page 56402]]

products which are adulterated'' and directs the Secretary of 
Agriculture to refuse inspection ``to any establishment whose premises, 
facilities, or equipment, or the operation thereof, fail to meet the 
(sanitation) requirements of this section.''
    FSIS does not need to specifically prohibit every action that could 
possibly lead to product adulteration or insanitary conditions. It 
would, in fact, be impossible to compile such a list of prohibited 
practices. FSIS inspection program employees currently have the 
authority to withhold the mark of inspection if an establishment fails 
to ensure that product is not adulterated or fails to maintain sanitary 
conditions, even if the failure in question is not specifically 
prohibited in the regulations. This authority remains unchanged under 
the new performance standards. For example, were an establishment 
employee to place a knife used on inspected product in his mouth, that 
action would be a violation of Sec. 416.5(a), ``All persons working in 
contact with product, food-contact surfaces, and product-packaging 
materials must adhere to hygienic practices while on duty to prevent 
adulteration of product.''
    Comment: Several commenters objected to the proposed rescission of 
the regulations requiring that various systems (such as plumbing and 
sewage systems) and activities (such as the use of sanitizers, 
pesticides, and other chemicals) be prior-approved by circuit 
supervisors or other FSIS program employees. These commenters claimed 
that many serious sanitation problems can be prevented only through 
prior-approval of such systems and activities by experienced FSIS 
program employees. Further, these commenters maintained that without 
prior approval, establishments will negligently use pesticides and 
other chemicals, adulterating product.
    Response: FSIS disagrees. In regard to the prior approval of 
establishment plumbing, sewage, and other systems, FSIS has made the 
determination that it should afford establishments the flexibility to 
determine what is appropriate and sufficient for maintaining sanitary 
conditions and preventing the adulteration of product. FSIS will verify 
that these systems meet the sanitation performance standards through 
inspection. FSIS already has rescinded the requirements for prior 
approval of establishment drawings, specifications, and equipment used 
in official establishments (62 FR 45015; August 25, 1997).
    In regard to the use of pesticides, sanitizers, and other 
chemicals, FSIS has determined that it is the establishment's 
responsibility to ensure that the chemicals it uses are safe and 
appropriate for use in its particular meat or poultry processing 
environment. Establishments will be required to account for the safety 
and appropriate use of these chemicals in their written HACCP plans, 
Sanitation SOP's, or in other documentation. A full discussion of this 
issue can be found below under the section entitled ``Cleaning 
Compounds and Sanitizers.''
    Comment: Finally, two commenters argued that the proposed 
performance standards could have a deleterious impact on trade. One 
stated that European countries with more stringent sanitation 
requirements would ban imports of U.S. meat and poultry products if the 
proposed performance standards were made final.
    Response: FSIS disagrees. Many of the United States' major 
agricultural trading partners have already implemented or are currently 
developing meat and poultry inspection systems incorporating 
performance standards or food safety objectives, rather than 
prescriptive, ``command-and-control'' regulations. Further, because the 
sanitation performance standards do not lower the existing food safety 
standards for meat and poultry, but instead only allow for increased 
flexibility and innovation to meet the prescribed standards, other 
countries would not be justified in imposing any new restrictions in 
response. Thus, FSIS anticipates that these new regulations will have 
no adverse impact on trade.

General Sanitation: Proposed Sec. 416.1

    Comment: Several commenters questioned the proposed performance 
standard language in Sec. 416.1 and elsewhere requiring that 
establishments be operated in a sanitary manner sufficient to prevent 
product from being ``misbranded.'' These commenters argued that there 
could never be a situation where insanitation by itself could lead to 
misbranding and, therefore, that the requirement is unnecessary.
    Response: FSIS agrees that it would be highly unlikely for any meat 
or poultry product to be misbranded as a result of insanitation and has 
removed the references to misbranding from Secs. 416.1, 416.2(c), and 
416.3. Establishments should keep in mind, however, that the 
misbranding of meat or poultry products is prohibited by the FMIA, the 
PPIA, and the regulations promulgated under those Acts. FSIS will take 
action in accordance with its statutory authority and the regulations 
any time it determines that meat or poultry products have been 
misbranded.
    Comment: Similarly, several commenters questioned the proposed rule 
language requiring that establishments operate in a sanitary manner in 
order to prevent both ``adulteration'' and ``contamination.'' These 
commenters argued that ``contamination'' is a very broad term that can 
describe problems with product quality or composition, as well as those 
associated with product safety. They maintained that a requirement to 
prevent ``adulteration'' would be sufficient, as ``adulteration'' is 
defined by both the FMIA and the PPIA.
    Response: FSIS agrees that the term ``contamination'' may cause 
some confusion and has removed the references to ``contamination'' 
throughout the rule language. FSIS emphasizes, however, that 
establishments must maintain sanitary conditions within their 
processing facilities, as insanitary conditions do lead to the 
adulteration of product. While the references to ``contamination'' have 
been removed, FSIS has added to the regulations the requirement that 
processing activities and the use of chemicals and equipment must not 
create insanitary conditions.

Establishment Grounds and Pest Management: Proposed Sec. 416.2(a)

    Comment: Several commenters objected to the language of proposed 
Sec. 416.2(a) regarding establishment grounds: ``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 
program employees from performing assigned tasks.'' The commenters 
contended that the phrase ``grounds about an establishment'' is 
inconsistent with recent FSIS policy that establishment management is 
responsible for defining the boundaries of their facilities. 
Specifically, commenters cite recent FSIS Directive 7640.1, 
``Inspection Duties Related to Facilities and Equipment, and Plant 
Operated Quality Control Programs,'' which states that inspection 
program employees are to request from establishment management written 
designation of the official premises' boundaries. Therefore, these 
commenters have suggested that ``grounds about an establishment'' be 
revised to read ``grounds as designated by the establishment.''
    Response: FSIS disagrees. The Agency sees no inconsistency between 
the directive and the performance standard as proposed. Proper 
maintenance of the

[[Page 56403]]

grounds about an establishment is essential for ensuring good 
sanitation. FSIS inspection program employees request written 
designation of establishment boundaries only to facilitate their 
inspection of the establishment. Establishments are responsible for 
preventing adulteration of product even if the sources are outside the 
designated boundaries of the establishment. Revising the performance 
standard to address only areas within the designated boundaries could 
mislead establishments into believing that they are not responsible for 
preventing such adulteration, especially when it originates from areas 
outside of the designated boundaries of the processing operations, but 
under the control of the establishment. Accordingly, FSIS is not making 
any changes to the rule language as proposed.
    Comment: FSIS proposed to require that establishments ``have in 
place an integrated pest management program to prevent the harborage 
and breeding of pests on the grounds and within establishment 
facilities.'' One commenter suggested that FSIS delete the word 
``integrated,'' arguing that it is confusing and unnecessary.
    Response: Integrated pest management (IPM) is a widely recognized 
system of agricultural pest control that takes into account pest 
ecology and the effect of pesticides and other pest control chemicals 
on the environment and on food. For the most part, IPM has been used 
within agricultural production systems. However, IPM also is applicable 
to meat and poultry processing.
    FSIS has rethought its tentative view that meat and poultry 
establishments should implement IPM systems. Although FSIS encourages 
establishments to develop or adopt IPM, FSIS has concluded that IPM is 
not absolutely necessary to ensure the production of unadulterated meat 
or poultry products. In this final rule, FSIS is requiring that any 
pest control system used by an establishment be designed and 
implemented so as to ensure that product is not adulterated either by 
pests or by the products designed to control them and, further, that 
the pest control system does not create insanitary conditions.
    Comment: The remaining comments on pest control addressed the 
proposal to eliminate the requirements that pesticides and rodenticides 
be approved by FSIS prior to their use in official establishments. 
Several commenters argued that without prior approval of pesticides and 
prescriptive requirements concerning their use, establishments will 
adulterate product or create insanitary conditions that could lead to 
adulteration.
    Response: FSIS' review and approval of pesticides and rodenticides 
prior to their intended use provided some assurance to meat and poultry 
processors that proper use of these compounds would not result in the 
adulteration or contamination of food products. However, FSIS has 
concluded after careful consideration of the issue that this prior 
approval program is unnecessary and inconsistent with HACCP. Under the 
HACCP regulations, establishments are responsible for developing and 
implementing HACCP plans incorporating the controls necessary and 
appropriate to produce safe meat and poultry products. Consequently, 
establishments are responsible for ensuring that the pesticides and 
rodenticides they use are safe and effective.
    Further, FSIS prior approval of pesticides and rodenticides has 
been somewhat redundant with the Environmental Protection Agency (EPA) 
requirements and review programs for these compounds. Under the Federal 
Insecticide, Fungicide, and Rodenticide Act (FIFRA), EPA reviews 
pesticide formulation, intended use, and other information; registers 
all pesticides for use in the United States; and prescribes labeling, 
use, and other regulatory requirements to prevent unreasonable adverse 
effects on the environment, including humans, wildlife, plants, and 
property. Any meat or poultry establishment using a pesticide must 
follow the FIFRA requirements.
    FSIS is requiring that documentation substantiating the safety of 
pesticides and rodenticides be available to FSIS inspection program 
employees for review (Sec. 416.4(c)). The documentation will need to 
include proof of EPA registration and could also include other any 
information, such as letters of guaranty from the manufacturer, labels, 
application instructions, and records of use that establish the safe 
and effective use of these products. FSIS inspection program employees 
will review these records as necessary, as well as observe the 
application and storage of pesticides and rodenticides to ensure the 
maintenance of sanitary conditions and that product is not adulterated. 
(For further discussion of prior approval of pesticides and other 
chemicals, see the section ``Cleaning Compounds and Sanitizers'' 
below.)

Establishment Construction: Proposed Sec. 416.2(b)

    Comment: Several commenters objected to the language of the 
proposed provision: ``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.'' Commenters argued that 
the requirement regarding ``sufficient size'' constitutes a new 
standard for sanitation. Commenters also argued that the phrase 
``sanitary processing, handling, and storage of product'' is too 
general; they suggested that the construction standard be based upon 
preventing adulteration of product.
    Response: FSIS disagrees that the requirement that rooms in an 
official establishment be of ``sufficient size'' constitutes a new 
standard. Although the previous regulations did not explicitly require 
rooms to be any particular size, the requirement that rooms be of 
sufficient size to prevent the adulteration of product was implicit. 
Moreover, this requirement is fully consistent with the FMIA and PPIA. 
An establishment would very likely be in violation of the statutory and 
regulatory prohibitions against product adulteration if its processing 
or storage rooms were so small that adequate separation of raw and 
ready-to-eat product were impossible. FSIS is merely making this 
requirement explicit in this performance standard.
    FSIS agrees that the proposed language regarding ``sanitary 
processing, handling, and storage of product'' should be revised to 
make clear the obligation specified in this regulation. For clarity and 
consistency with the other performance standards, FSIS is revising this 
performance standard to read: ``Establishment buildings, including 
their structures, rooms, and compartments must be of sound 
construction, be kept in good repair, and be of sufficient size to 
allow for processing, handling, and storage of product in a manner that 
does not result in product adulteration or the creation of insanitary 
conditions.''
    Comment: A few commenters stated that while large establishments 
might be able to innovate effectively under the proposed performance 
standards for construction, many small establishments lack the 
expertise to innovate in facility construction and design and need to 
follow specific requirements in order to maintain sanitary operations 
that produce safe meat and poultry products.
    Response: FSIS disagrees. The design or alteration of facility 
construction or layout is well within the capability of most, if not 
all, meat and poultry establishments, regardless of size.

[[Page 56404]]

Moreover, in this rule, FSIS is not requiring establishments to 
innovate in regard to facility construction or layout. Establishments 
currently maintaining sanitary conditions will not need to make any 
changes to their construction or layout as a result of this performance 
standard. Further, FSIS is making available a compliance guide for the 
sanitation performance standards, including the standards for 
construction. Establishments remodeling or undertaking new construction 
may consult this guide or the various national building and 
construction codes, State and local laws and codes, and other relevant 
resources available from trade associations, consultants, and nonprofit 
organizations.
    Comment: One commenter questioned FSIS' recommendation that 
establishments consult the Food Code, as well as national building and 
construction codes, when designing or building facilities. The 
commenter maintained that because these documents have no force of law, 
establishments do not have to follow their guidance, and further, that 
these documents are not always applicable to the unique requirements of 
meat and poultry processing establishments. This commenter concluded 
that specific design and construction requirements are necessary to 
ensure that meat and poultry establishments are built properly.
    Response: FSIS does not agree that specific requirements for 
establishment design and construction are necessary to ensure that meat 
and poultry are not adulterated. FSIS is adopting performance standards 
for construction that provide establishments, regardless of size, the 
flexibility to design facilities and equipment in the manner they deem 
best to maintain the required sanitary environment for food production. 
Further, as stated above, if establishments are maintaining sanitary 
conditions, there is no reason to believe that they will not be in 
compliance with the new performance standards for design and 
construction, as long as their facilities are maintained in good 
repair. Also, as stated above, they may follow the recommendations in 
the Food Code or the national building and construction codes, many of 
which have been adopted as requirements by State and local governments. 
If establishments do so, they should be in compliance with the 
standards.
    Comment: One commenter requested that FSIS delete the examples of 
vermin given in proposed Sec. 416.2(b)(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.'' The commenter argued that these examples are unnecessary.
    Response: These examples are illustrative of the types of vermin 
known to commonly infest meat and poultry establishments and, 
therefore, FSIS is retaining them in the regulations.
    Comment: Finally, although no commenter specifically addressed the 
proposed standard concerning the separation of edible and inedible 
product, FSIS believes that the proposed standard could be 
misunderstood and is making a revision to clarify its intent. FSIS 
proposed to require that ``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.'' FSIS did not intend to imply that rooms where 
edible product is processed, handled, or stored could never be used for 
the processing, handling or storage of inedible product. FSIS has 
allowed, and will continue to allow, establishments to process, handle, 
or store edible and inedible product in the same room as long as they 
are separated by time or space, in a manner sufficient to prevent the 
adulteration of the edible product or the creation of insanitary 
conditions.
    Response: FSIS is adopting a revised standard that states: ``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, to the extent 
necessary to prevent product adulteration and the creation of 
insanitary conditions.''

Light: Proposed Sec. 416.2(c)

    Comment: A few commenters opposed the proposed performance standard 
that establishments provide ``Lighting of good quality and sufficient 
intensity to ensure that sanitary conditions are maintained and that 
product is not adulterated *  *  *'' These commenters maintained that 
by allowing establishments to determine whether light quality and 
intensity is sufficient, FSIS, in fact, would be allowing 
establishments to provide lighting that is not sufficient to ensure 
sanitation. One commenter doubted that establishments would follow the 
recommendations for lighting contained in the Food Code, as suggested 
by FSIS. Another commenter recommended that FSIS maintain the existing 
30-foot candle requirement for light intensity at poultry working 
surfaces and extend the same requirement to meat establishments.
    Response: FSIS disagrees. FSIS does not believe it is necessary to 
prescribe specific light intensities to ensure sanitation in meat and 
poultry processing areas because establishments must determine what 
light intensities are appropriate to ensure sanitation in different 
operational contexts. Importantly, however, as with all of the 
sanitation performance standards, FSIS will continue to verify through 
inspection that the lighting meets the performance standard.
    The previous requirements for lighting in poultry establishments in 
Sec. 381.52 prescribed specific light intensities for different areas 
of the establishment. For example, FSIS required that all rooms in 
which poultry was 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) did not 
contain such specific requirements, but required only that meat 
establishments have ``abundant light, of good quality and well 
distributed.'' However, the intent of these requirements was 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 adulteration. New 
Sec. 416.2(c) establishes this intent as a single performance standard 
applicable to both meat and poultry establishments, which is wholly 
consistent with the purpose of the current regulations.
    It also is important to note that FSIS is not rescinding the 
specific light intensity requirements for inspection program employee 
and reprocessing stations set out in Secs. 307.2 and 381.36. FSIS has 
determined that these specific requirements are still necessary to 
ensure appropriate conditions for effective inspection.

Ventilation: Proposed Sec. 416.2(d)

    Comment: FSIS proposed that meat and poultry establishments provide 
``ventilation adequate to eliminate odors, vapors, and condensation.'' 
Several commenters maintained that it would be impossible for 
establishments to ``eliminate'' odors, vapors, and condensation. They 
suggested that the standard be revised to require that ventilation be 
adequate to control odors, vapors, and condensation to the extent 
necessary to prevent the adulteration of product.
    Response: FSIS agrees and has revised the standard to require that 
ventilation be adequate to control odors, vapors,

[[Page 56405]]

and condensation to the extent necessary to prevent adulteration of 
product and to prevent the creation of insanitary conditions which can 
lead to product adulteration.

Plumbing and Sewage Disposal: Proposed Secs. 416.2(e) and (f)

    Comment: In the preamble to the proposed rule, FSIS recommended 
that establishments consult the National Plumbing code when designing 
or building a plumbing system and stated that ``a plumbing system in 
compliance with the National Plumbing Code in most instances would meet 
the proposed performance standards for plumbing.'' One commenter 
supported the use of the National Plumbing Code by establishments but 
questioned whether there were certain provisions in the Code that FSIS 
has determined would be inadequate to meet the performance standard.
    Response: FSIS has not determined that any of the provisions of the 
National Plumbing Code are inappropriate or inadequate as models for 
plumbing systems in meat and poultry establishments. However, 
compliance with the National Plumbing Code or any other code does not 
necessarily establish compliance with FSIS regulations. For instance, 
it could be possible to build a plumbing system that meets the 
standards of the National Plumbing Code but also creates insanitary 
conditions that could cause the adulteration of product. FSIS continues 
to recommend that meat and poultry establishments consult the National 
Plumbing Code when designing or building a plumbing system, but also 
encourages establishments to keep in mind the relevant requirements of 
FSIS, other Federal Agencies, and State and local governments.
    Comment: A few commenters opposed the removal of requirements that 
features of plumbing and sewage systems, such as traps and vents, be 
prior-approved by FSIS program employees for safety and efficacy.
    Response: As the Agency has stated throughout this document, FSIS 
fundamentally disagrees with those commenters who oppose the 
elimination of prior approval requirements. It is the responsibility of 
the establishment to ensure that plumbing and sewage systems provide an 
adequate supply of potable water for processing and other purposes and 
move waste and sewage from the establishment without adulterating 
product or creating insanitary conditions. There are many ways to 
achieve these goals that are consistent with FSIS regulations, State 
and local laws, and the Food Code. Required prior approval of these 
systems undercuts this objective and would deprive establishments of 
the flexibility to innovate and create sound, effective plumbing and 
sewage systems that ensure sanitary operating conditions. FSIS will 
continue to verify, through inspection, that plumbing and sewage 
systems neither adulterate product nor create insanitary conditions.

Water Supply and Reuse: Proposed Sec. 416.2(g)

    Comment: One commenter believed that FSIS suggested in the preamble 
to the proposal that compliance with the EPA standard for water 
potability might not be sufficient to ensure that water used by meat 
and poultry establishments is potable.
    Response: FSIS proposed a water supply performance standard 
intended to make transparent the current requirement that potable water 
comply with EPA's 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. The EPA standard of water 
potability is sufficient and FSIS is adopting the performance standard 
as proposed.
    Comment: Another commenter questioned the proposed requirement that 
establishments make available to FSIS any water reports ``issued under 
the authority of the State health agency, certifying or attesting to 
the quality of the water supply.'' The commenter argued that this 
requirement would be ineffective as an indicator of water potability 
unless FSIS specified the frequency at which an establishment must have 
its water supply tested.
    Response: The EPA National Primary Drinking Water regulations, 
contained in 40 CFR part 141, require testing of drinking water for 
fecal coliforms and other contaminants at specified frequencies. 
Because FSIS is requiring that water used by meat and poultry 
establishments meet the EPA requirements, which include testing 
requirements, FSIS does not need to promulgate separate testing 
requirements. Certifications of water potability provided by State or 
local governments or other responsible entities will show whether water 
meets the EPA requirements.
    Some meat and poultry establishments use private wells for their 
water supply. EPA classifies private wells as ``noncommunity'' water 
sources and does not require testing for potability. It also is 
unlikely that State or local governments would test such wells for 
potability. If an establishment uses a private well, FSIS is requiring 
that the establishment make available to FSIS documentation, renewed at 
least semi-annually, certifying the potability of its private well 
water. Most establishments will obtain this documentation from private 
laboratories.
    FSIS is finalizing this requirement concerning the potability of 
well water in response to the above comment. Although the Agency did 
not specifically propose this approach, it is consistent with the 
proposal, which focused on how to ensure the potability of water used 
in all establishments. Moreover, it is not a new requirement. It is the 
codification of a policy that FSIS has been enforcing under FSIS 
Directive 11,000.1, the ``Sanitation Handbook for Meat and Poultry 
Inspection.'' This Directive was rescinded by FSIS Notice 3-98 on 
January 16, 1998. Another FSIS document concerning this policy, 
entitled ``Approved Water Systems,'' will be rescinded upon the 
effective date of this rule.
    Comment: Several commenters objected to the proposed performance 
standards for water reuse because, they argued, the proposed standards 
would allow establishments to wash raw product, equipment, and utensils 
with non-potable water, and the possibility of product adulteration 
would therefore be greatly increased. One commenter suggested that FSIS 
require water to be ``heat pasteurized'' before reuse on raw or ready-
to-eat product.
    Response: In many circumstances, establishments can reuse water in 
a manner that will neither adulterate product nor create insanitary 
conditions. FSIS already permits certain uses of nonpotable water. For 
example, water is recirculated in tanks to chill raw poultry; water 
treated by an advanced wastewater treatment system can be used to wash 
equipment or raw product, if followed by a potable water rinse; and 
nonpotable, reuse water can be used to wash floors or equipment in 
areas where edible product is not handled. FSIS is making final 
performance standards that will provide for the reuse of water in 
numerous processing contexts, provided that the establishment takes 
actions necessary to ensure that product is not adulterated by the 
water and that sanitation is not compromised. Establishments are 
required to document and monitor water reuse activities either in their 
Sanitation SOP's or HACCP plans.
    Comment: One commenter expressed concern about the proposed 
requirement

[[Page 56406]]

that water used or reused to chill or cook ready-to-eat product be free 
of pathogens. This commenter and others stated that the stated goal of 
the performance standards for water, processing solution, and ice reuse 
should be to prevent meat and poultry products from becoming 
adulterated by pathogens, rather than preventing water, ice, or 
solutions from being contaminated with pathogens, fecal coliforms, and 
other hazardous substances. These commenters maintained that 
establishments will control pathogens in the processing environment, in 
this case water, through HACCP and Sanitation SOP's and recommended 
that the performance standards for water, ice, and solutions reuse be 
revised accordingly.
    Response: FSIS does not agree with the commenters' suggestion. In 
many cases, the presence of fecal coliforms, pathogens, or other 
contaminants in reuse water, ice, or processing solutions indicates 
insanitation that may, in fact, lead to the adulteration of meat and 
poultry products. The control of pathogens in water used in processing, 
therefore, is essential for ensuring that meat and poultry products do 
not become adulterated. The performance standards establish the 
necessary conditions to ensure that water, ice, and solution reuse do 
not compromise sanitation or cause the adulteration of product. 
Establishment Sanitation SOP's and HACCP plans must provide for 
compliance with these sanitation standards.

Ice and Solution Reuse: Proposed Sec. 416.2(h)

    Comment: Several commenters maintained that the hazards inherent in 
ice and solution reuse were identical to those in water reuse and 
suggested, therefore, that the performance standards be combined for 
consistency.
    Response: FSIS agrees and has made final a single set of reuse 
performance standards applicable to water, ice, and solutions. However, 
because of the different physical characteristics and uses of water, 
ice, and solutions, it is expected that establishments will meet the 
performance standards for these substances in different ways. For 
example, an establishment recirculating water in a chill tank for raw 
poultry might add chlorine to the water to reduce the number of 
pathogens. An establishment reusing ice to chill raw poultry might bag 
the ice to prevent it from contacting product.

Dressing Rooms, Lavatories, and Toilets: Proposed Sec. 416.2(i)

    Comment: Numerous commenters opposed the proposed performance 
standard concerning the number of lavatories and toilet facilities in 
official establishments:

    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.

These commenters claimed that many establishments have crowded, 
insanitary conditions now, and, if given this performance standard 
instead of a more prescriptive requirement, establishments would not 
provide a sufficient number of lavatories and toilet facilities. One 
commenter, however, argued that the standard is, in fact, too 
prescriptive in that it requires separate facilities for both sexes. 
This commenter stated that Federal, State, and local labor laws already 
provide for this.
    Response: As the Agency has stated throughout this document, it is 
prudent and reasonable to replace prescriptive sanitation requirements 
with performance standards that articulate the objectives or results 
that establishments must achieve. Thus, FSIS is replacing the 
prescriptive requirements concerning establishment lavatories, toilet 
facilities, and their sanitation with a performance standard. 
Furthermore, other Federal law already does govern lavatories and 
toilet facilities in places of employment.
    The Occupational Safety and Health Administration (OSHA) of the 
Department of Labor has promulgated regulations concerning toilet 
facilities in the workplace in 29 CFR 1910.141, ``Sanitation.'' 
Paragraph (c)(1)(i) of this regulation sets forth requirements for the 
number of toilet facilities in all permanent places of employment. 
Official meat and poultry establishments are governed by these 
requirements. Thus, FSIS has determined that it is not necessary to add 
a more specific provision regarding the number of toilets to the 
performance standard it proposed.
    In regard to the issue of requiring separate toilet facilities for 
men and women, OSHA also has set forth requirements, again in 29 CFR 
1910.141(c)(1)(i): ``toilet facilities, in toilet rooms separate for 
each sex, shall be provided in all places of employment,'' and, 
further, ``Where toilet rooms will be occupied by no more than one 
person at a time, can be locked from the inside, and contain at least 
one water closet, separate toilet rooms for each sex need not be 
provided.'' For consistency with this OSHA requirement, FSIS has 
removed the proposed provision requiring separate lavatories and toilet 
facilities.

Equipment and Utensils: Proposed Sec. 416.3

    Comment: Numerous commenters objected to the proposed elimination 
of the requirement in Secs. 308.3(d)(4) and 308.8 that utensils and 
equipment used to dress diseased meat carcasses be cleaned with either 
180 ( deg.F water or an approved disinfectant. Several commenters 
contended that the use of 180 ( deg.F water has been the method 
``proven'' to be effective for sanitizing implements. These commenters 
submitted no supporting data, however. A few commenters recommended 
that FSIS require a minimum water temperature of at least 155  deg.F to 
160  deg.F, as water in this temperature range is purported to kill E. 
coli O157:H7. Several commenters questioned the studies cited by FSIS 
as support for rescinding the 180  deg.F requirement. These commenters 
recommended that FSIS commission or conduct a new study to determine 
the water temperature that is most effective for controlling bacteria 
in a slaughter environment. Finally, one commenter argued that by 
rescinding the 180  deg.F water requirement, FSIS is contradicting its 
other policy of ``promoting'' the use of steam cabinets as a processing 
step to kill bacteria.
    Response: For HACCP systems to be effective, meat and poultry 
establishments must be afforded the flexibility to take whatever 
actions are necessary to produce safe products. Meat establishments 
must determine what is necessary, in the particular context of their 
processing environment, to clean implements used to dress diseased 
carcasses so that those implements will not adulterate product. Under 
the performance standard, many meat establishments are likely to 
continue using 180  deg.F water for this purpose, but others will use 
different means that they will have determined are more suitable and as 
effective.
    The studies summarized by FSIS in the proposal raise significant 
questions about the efficacy of 180  deg.F water for the cleaning of 
implements used to dress diseased carcasses. FSIS cited these studies 
to emphasize that this prescribed treatment may not be effective in 
every processing

[[Page 56407]]

environment and, therefore, that a performance standard would be more 
appropriate for ensuring that meat establishments maintain proper 
sanitation within their operations. FSIS is not planning to conduct or 
sponsor any additional studies at this time, but certainly will 
evaluate any research developments in this area.
    Finally, FSIS has endorsed the use of steam pasteurization as an 
antimicrobial treatment for the surfaces of meat carcasses. FSIS has 
not prescribed, however, a specific temperature for the steam or a 
specific method for its application. Similarly, FSIS will no longer 
require a specific method for the cleaning of implements used to dress 
diseased carcasses.
    Comment: Several commenters opposed the proposed performance 
standard regarding equipment and FSIS inspection program employees: 
``Equipment and utensils must not interfere with inspection procedures 
or interfere with inspection by FSIS inspection personnel.'' These 
commenters argued that this standard is unnecessary because the general 
requirement that establishments not interfere with FSIS inspection is 
implicit in all of the regulations.
    Response: The FMIA, PPIA, and the regulations specifically prohibit 
the forcible interference with FSIS program employees performing 
inspection or any other duties prescribed by the FMIA, PPIA, or the 
regulations. Moreover, the requirement that establishments not 
interfere with FSIS inspection is implicit throughout FSIS regulations. 
However, it is important to establish a performance standard regarding 
the inspection of the sanitary condition of equipment. Equipment in an 
official establishment must not be constructed or operated in a manner 
that would prevent FSIS inspection program employees from determining 
whether the equipment is in sanitary condition. If meat or poultry 
processing equipment is built, located, or operated in a manner that 
prevents it from being inspected to determine whether it has been 
cleaned or sanitized so as to ensure that it will not be the cause of 
product adulteration, FSIS may withhold the mark of inspection from 
product processed using that equipment. FSIS has revised the proposed 
performance standard, as follows, to clarify this intent: ``Equipment 
and utensils must not be constructed, located, or operated in a manner 
that prevents FSIS inspection program employees from inspecting 
equipment or utensils to determine whether they are in sanitary 
condition.''

Food Contact Surface Cleaning and Sanitation: Proposed Sec. 416.4(a)

    Comment: Numerous commenters objected to the proposed requirement 
that ``all food-contact surfaces, including food-contact surfaces of 
utensils and equipment, must be cleaned daily prior to starting 
operations  *  *  * .'' Commenters stated that many establishments 
currently operate successfully for extended periods (more than 24 
hours), cleaning and sanitizing as necessary. Also, several commenters 
noted that certain types of equipment, such as blast freezers and high 
temperature ovens, can be operated over extended periods without posing 
a significant food safety risk. Finally, a few commenters suggested 
that an establishment's Sanitation SOP or HACCP plan should dictate 
frequency of cleaning food contact surfaces.
    Response: FSIS agrees that it is possible for an official 
establishment to safely operate for an extended period (more than 24 
hours) without re-sanitizing all food contact surfaces. It is also true 
that more frequent sanitizing may be necessary. Accordingly, FSIS is 
finalizing a performance standard for operational sanitation requiring 
that ``All food-contact surfaces, including food-contact surfaces of 
utensils and equipment, must be cleaned and sanitized as frequently as 
necessary to prevent the creation of insanitary conditions and the 
adulteration of product.'' The regulation, as revised, is consistent 
with the Sanitation SOP and HACCP requirements. Establishments must 
comply with the Sanitation SOP requirements regarding food contact 
surfaces in Sec. 416.12(c): ``Procedures in the Sanitation SOP's that 
are to be conducted prior to operations shall be identified as such, 
and shall address, at a minimum, the cleaning of food contact surfaces 
of facilities, equipment, and utensils.''

Non-Food Contact Surface Cleaning and Sanitation: Proposed 
Sec. 416.4(b)

    Comment: Several commenters stated that the language proposed for 
the performance standard for non-food contact surfaces was 
unnecessarily prescriptive and inconsistent with the other performance 
standards because it required that such surfaces be cleaned ``as 
necessary to prevent the physical, chemical, or biological 
contamination or adulteration of product,'' rather than simply to 
prevent adulteration of product.
    Response: FSIS agrees and has revised the standard to be consistent 
with the revised standard in Sec. 416.4(a): ``Non-food-contact surfaces 
of facilities, equipment, and utensils used in the operation of the 
establishment must be cleaned and sanitized as frequently as necessary 
to prevent the creation of insanitary conditions and the adulteration 
of product.'' Obviously, during the normal course of an establishment's 
operations, meat and poultry products should not come in contact with 
``non-food contact surfaces.'' Therefore, as long as such contact did 
not occur, it would be unlikely that these surfaces would ever directly 
adulterate product. However, if non-food contact surfaces are 
insufficiently cleaned or sanitized, insanitary conditions within the 
establishment can result, potentially leading to product adulteration. 
FSIS has revised this performance standard by deleting the specific 
reference to ``physical, chemical, or biological contamination'' and by 
requiring that non-food contact surfaces be cleaned and sanitized as 
necessary to prevent the creation of insanitary conditions and the 
adulteration of product.
    Comment: One commenter claimed that non-food contact surfaces in 
establishments, such as floors, drains, and walls, are highly 
contaminated. This commenter suggested that FSIS revise the performance 
standard to require daily cleaning and sanitizing of non-food contact 
surfaces.
    Response: In many establishments, daily cleaning and sanitizing of 
non-food contact surfaces may not be necessary for the maintenance of 
sanitary conditions or the prevention of product adulteration. FSIS 
will not, therefore, mandate specific time intervals for this 
requirement. If the conditions in an establishment are such that 
floors, drains, walls, and other non-food contact surfaces are highly 
contaminated on a regular basis, the establishment may need to provide 
for the appropriate frequency of cleaning and sanitizing of those 
surfaces in either its HACCP plan or Sanitation SOP's. FSIS is 
confident that insanitary conditions of non-food contact surfaces in 
official establishments will be detected by FSIS inspection program 
employees during verification of an establishment's HACCP plans and 
written Sanitation SOP's.

Cleaning Compounds and Sanitizers: Proposed Sec. 416.4(c)

    FSIS proposed to eliminate the regulatory requirements mandating 
that certain nonfood compounds and proprietary substances be approved 
by the Agency prior to their use. Specifically, FSIS proposed to 
rescind the following regulations:

[[Page 56408]]

    Sec. 308.3(h)--requirements that FSIS approve pesticides, 
rodenticides, and insecticides prior to use in certain areas of meat 
establishments;
    Sec. 308.8(c)--requirements that FSIS approve, prior to use, 
disinfectants used to clean implements that have contacted diseased 
meat carcasses; and
    Sec. 381.60--requirements that germicides, insecticides, 
rodenticides, detergents, wetting agents, and similar compounds be 
approved by FSIS prior to use in poultry establishments.
    FSIS did not propose to discontinue its policy of approving other 
proprietary substances or nonfood compounds prior to their use in 
official establishments. As a matter of policy, FSIS has reviewed and 
approved, prior to use, most other nonfood compounds and proprietary 
substances, including: branding and tattoo inks; poultry and hog scald 
agents; rendering agents; certain cleaning compounds; paint removers; 
antimicrobial agents; hand washing and sanitizing agents; water 
treatments; solvent cleaners; sewer and drain cleaners; and lubricants. 
Following its review, FSIS has listed all approved nonfood compounds 
and proprietary substances in Miscellaneous Publication Number 1419, 
List of Proprietary Substances and Nonfood Compounds.
    Shortly after FSIS published the proposal to revise the sanitation 
regulations, FSIS mistakenly released information that mischaracterized 
the proposal's provisions concerning the prior approval of nonfood 
compounds and proprietary substances. On September 11, 1997, the FSIS 
Compound and Packaging Review Branch mailed a notice to chemical 
manufacturers and other businesses announcing a change of address. 
Included with that notice was a facsimile of the first page of a 
proposed rule, incorrectly identified as the sanitation proposal, FSIS 
Docket No. 96-037P, announcing that the Agency was discontinuing its 
policy of approving all nonfood compounds and proprietary substances 
prior to their use in official meat and poultry establishments.
    In order to clear up any confusion regarding the matter, FSIS 
published a notice in the Federal Register (FSIS Docket No. 97-062N; 62 
FR 55995) explaining the situation and correcting the erroneous 
information. Further, in order to ensure that the public had ample 
opportunity to submit comments on the sanitation proposal and its 
provisions concerning nonfood compounds and proprietary substances, 
FSIS reopened the comment period for that proposal for 15 days, from 
October 28, 1997, to November 10, 1997 (FSIS Docket 96-037R; 62 FR 
55997).
    On February 13, 1998, FSIS announced in a notice (FSIS Docket No. 
97-007N; 63 FR 7319) that it did, in fact, intend to discontinue 
approving all nonfood compounds and proprietary substances prior to 
their use in official meat and poultry products establishments. FSIS 
emphasized that it would continue to require that meat and poultry 
products be neither adulterated nor misbranded through the misuse of 
proprietary additives and nonfood compounds. Further, FSIS also 
explained its plan to maintain a small staff with expertise in nonfood 
compounds and proprietary substances. This staff will keep abreast of 
developments in chemical manufacturing and use, maintain liaison with 
outside organizations that have an interest in this matter, and issue 
technical guidance, particularly to small meat and poultry plants, as 
circumstances warrant. Finally, FSIS requested comment on possible 
alternatives to the FSIS prior approval program, including the option 
of third party review and approval of nonfood compounds and proprietary 
substances.
    The comments FSIS received on this issue, whether in response to 
the sanitation proposal, the letter distributed by the Compounds and 
Packaging Review Branch, or the February 13 notice, do not differ 
substantively. While a few commenters supported the proposed regulatory 
and policy changes, most of the comments were submitted by chemical 
manufacturers, and most were in opposition to ending the prior approval 
program for all nonfood compounds and proprietary substances. In 
response to the letter, FSIS received 68 comments. Because these 
commenters believed that they were responding to an FSIS proposed 
rulemaking, FSIS maintained their comments on file in the FSIS Docket 
Room. In response to the February 13 notice, FSIS received 35 comments. 
Below, FSIS responds to all of the issues raised in all of the comments 
concerning the FSIS plan to eliminate the prior approval program.
    Comment: The majority of commenters opposed to ending the prior 
approval program argued that without prior approval, unscrupulous 
chemical manufacturers will market unsuitable and possibly dangerous 
chemicals to meat and poultry establishments and that the use of such 
chemicals would inevitably lead to the adulteration of product. 
Further, they argued that it would be difficult for FSIS inspection 
program employees to prevent such adulteration since they would not be 
able to consult the List of Proprietary Substances and Nonfood 
Compounds. Several commenters contended that without the List of 
Proprietary Substances and Nonfood Compounds, FSIS inspection program 
employees will make inconsistent or arbitrary decisions in regard to 
what compounds establishments may use.
    Response: FSIS disagrees. The FMIA and PPIA require that meat and 
poultry products be neither adulterated nor misbranded through the use 
of proprietary substances and nonfood compounds. Meat and poultry 
establishments are responsible for ensuring that all proprietary 
substances and nonfood compounds are safe for their intended use and 
used appropriately. In light of these requirements, FSIS anticipates 
that establishments considering purchasing and using nonfood compounds 
or proprietary substances will demand formulation or other information 
from chemical manufacturers before making purchase decisions. 
Manufacturers who fail to provide such information could lose their 
market share.
    FSIS inspection program employees will continue to verify that 
proprietary substances and nonfood compounds do not adulterate meat and 
poultry products. Enforcement activities in this regard will include, 
but will not be limited to, direct observation of establishment 
operations and inspection of an establishment's premises and product, 
as well as sampling of product for chemical residues, as necessary, and 
review of establishment records. Establishments will document the use 
of proprietary substances and nonfood compounds in a variety of 
records, depending on the nature of the compound and its use. FSIS 
inspection program employees will review Sanitation SOP's, HACCP plans, 
use directions, pest control certifications, letters of guarantee, and 
other materials furnished to establishments by chemical manufacturers 
and suppliers.
    In response to comments, FSIS is finalizing an additional 
regulatory requirement in regard to the use of nonfood compounds and 
proprietary substances in Sec. 416.4(c): ``Documentation substantiating 
the safety of a chemical's use in a food processing environment must be 
available to FSIS inspection program employees for review.'' FSIS is 
not requiring that establishments make available any specific type of 
documentation since, as stated above, documentation substantiating the 
safety of a chemical varies with the nature and intended uses of that 
chemical. For example, for a pesticide, an

[[Page 56409]]

establishment should have documentation showing that the compound is 
registered with EPA and the label information for the pesticide. For a 
chemical sanitizer used on food contact surfaces, an establishment 
should have documentation showing that the compound complies with the 
relevant Food and Drug Administration (FDA) regulations in 21 CFR 
178.1010. For an antislip agent, an establishment may satisfy the 
regulations with a letter of guarantee and use instructions from the 
manufacturer certifying that if used in accordance with directions, the 
compound will neither adulterate product nor create insanitary 
conditions. This documentation requirement not only will assist FSIS 
inspection program employees in determining whether the use of given 
compound is proper and safe, but also will ensure that meat and poultry 
establishments have adequately reviewed and evaluated the chemicals 
used in their food processing environments.
    FSIS inspection program employees may, of course, disallow a 
specific use of a chemical in an official establishment if 
documentation is not available or is inadequate, if the establishment 
misuses the nonfood compound or proprietary substance, or if there is 
reason to believe a specific use will lead to insanitation or product 
adulteration. FSIS program employees will be instructed to direct any 
questions or concerns regarding the use of nonfood compounds and 
proprietary substances to the FSIS Technical Services Center. Further, 
FSIS is publishing a new Directive to assist inspection program 
employees in verifying the safety of the use of nonfood compounds and 
proprietary substances in official meat and poultry establishments.
    Comment: Some commenters maintained that small establishments lack 
the resources and technical expertise to determine whether chemical 
compounds are safe and effective and, therefore, would be adversely 
affected by the elimination of FSIS review and approval. Several of 
these commenters urged FSIS to provide guidance material to industry 
concerning the appropriate formulation and use of nonfood compounds and 
proprietary substances.
    Response: FSIS does not anticipate that the elimination of its 
prior approval program will substantially affect small meat and poultry 
establishments. These establishments are or should be already aware of 
which chemicals have been approved by FSIS. Moreover, competition will 
compel chemical manufacturers to provide meat and poultry 
establishments of all sizes with data that establish that their 
compounds are safe and effective. Likewise, FSIS is making available 
guidelines for compliance with the sanitation performance standards 
that explicitly address the appropriate formulation and safe use of 
nonfood compounds and proprietary substances. The guidelines are based 
upon the FSIS's regulatory experience, the requirements of other 
Federal agencies, and the criteria previously used by FSIS for 
reviewing and approving nonfood compounds and proprietary substances. 
Establishments should refer to those guidelines. Furthermore, although 
the guidelines are directed primarily to regulated meat and poultry 
establishments, chemical manufacturers may find them useful in 
developing and marketing their products.
    Comment: A few commenters, including several non-government 
standard-setting organizations, strongly supported third-party review 
and certification of nonfood compounds and proprietary substances.
    Response: FSIS encourages third-party standards organizations and 
independent laboratories to develop systems for testing and certifying 
nonfood compounds and proprietary substances. Such certification would 
encourage the development and marketing of effective, safe, and 
innovative products. Chemical manufacturers whose products meet FSIS 
performance standards and other agency requirements will have ample 
incentive to publicize the fact that their products are approved by 
third party organizations or independent laboratories. It is not likely 
that FSIS will officially sanction any particular organization's 
certification as definitive evidence of compliance with FSIS 
requirements. However, FSIS would obviously give careful consideration 
to valid third-party certifications when questions arise regarding the 
safety of a nonfood compound or proprietary substance.
    Comment: Several commenters noted that some of the nonfood 
compounds and proprietary substances previously approved by FSIS, 
including general cleaners, hand soaps, sewer and drain cleaners, and 
certain water treatments, are not, in fact, reviewed or approved by 
other Federal agencies. These commenters contended that, consequently, 
continued review and approval of these compounds by FSIS is necessary. 
In one comment, FDA raised specific concerns regarding the proposed 
discontinuation of prior approval for hand cleaners and sanitizers. 
Although some hand treatments are considered over-the-counter drug 
products and therefore regulated by FDA, others are not.
    Response: FSIS does not agree that prior approval of these 
chemicals is necessary to ensure the safety of meat and poultry 
products. Meat and poultry establishments have the responsibility of 
ensuring that the nonfood compounds and proprietary substances that 
they use will not adulterate product or create insanitary conditions. 
As stated above, FSIS will verify that these chemicals are being used 
appropriately through inspection, review of documentation 
substantiating the safety of the chemicals, and if necessary, sampling 
and testing. FSIS anticipates that competition will compel chemical 
manufacturers to demonstrate to meat and poultry establishments that 
their products are safe and satisfy the standards established in these 
regulations.
    Specifically in regard to the use of hand treatments and 
sanitizers, FSIS prior approval is unnecessary. Hand care products 
formulated with chlorhexidene gluconate and intended to be used as an 
antimicrobial hand cleaner or hand sanitizer/dip in food handling and 
processing, as well as hand care treatments intended for use as a 
``barrier'' or ``shield'' to prevent or mitigate human disease by 
protecting skin from exposure to toxic chemicals or pathogenic 
microorganisms, are considered ``drugs'' and possibly ``new drugs'' 
under the Federal Food, Drug, and Cosmetic Act (FFDCA). Consequently, 
FDA regulates and registers these hand treatments. Establishments using 
such chemicals should keep registrations on file for review by FSIS 
inspection program employees.
    Other hand treatments, however, are not currently regulated or 
registered by FDA. It is the responsibility of establishments to ensure 
that such treatments do not adulterate product or create insanitary 
conditions. As with other chemicals, FSIS will verify that hand 
treatments are being used appropriately through inspection, review of 
documentation substantiating the safety of the chemicals, and if 
necessary, sampling and testing. FSIS is publishing guidance on the 
appropriate use of hand treatments in the sanitation performance 
standards compliance guide. FSIS also is continuing to consult with FDA 
regarding the appropriate use of hand treatments, and will modify the 
compliance guide in the event of changes in FDA policies.
    Comment: One trade association cited concerns regarding labeling 
and

[[Page 56410]]

marketing claims for nonfood compounds and proprietary substances 
previously approved and listed by FSIS. This commenter requested that 
FSIS explicitly allow manufacturers of previously approved chemicals to 
market them as such.
    Response: FSIS will neither approve nor disapprove marketing claims 
or labeling for the nonfood compounds and proprietary substances used 
in establishments. Chemical manufacturers may market or label their 
products as being previously approved by FSIS, as long as their claims 
are truthful and not misleading, as is required by applicable law. Meat 
and poultry establishments should keep in mind that since FSIS is 
discontinuing its prior approval program for these products, previous 
approval of a product by FSIS does not necessarily mean that it is 
safer or more effective than a new product that has not been reviewed 
and approved.
    Documentation required to be available under the regulation may 
cite that products were previously approved by FSIS for a particular 
use and that the formulation of that product has not changed. This 
information may facilitate decisions by FSIS program employees when 
reviewing documentation that substantiates the safety of a nonfood 
compound or proprietary substance.
    Comment: A few commenters argued that in regard to the proposed 
elimination of its prior approval program, FSIS must perform 
environmental impact analyses pursuant to the requirements of the 
National Environmental Policy Act (NEPA, 42 U.S.C. 4321 et seq.) and 
the Council for Environmental Quality regulations in 40 CFR parts 1500-
1508. These commenters noted that FSIS has been granted a categorical 
exclusion from NEPA requirements by USDA regulation (7 CFR 1b.4), 
unless ``the agency head determines that an action may have a 
significant environmental effect.'' They concluded that the elimination 
of prior approval for nonfood compounds and proprietary substances in 
general, and specifically for pesticides, could have a significant, 
adverse impact on human health and the environment and therefore that 
FSIS should conduct an environmental assessment or impact analysis as 
required by NEPA. Two commenters also claimed that FSIS's planned 
elimination of its prior approval program is inconsistent with the 
intent of E.O. 13045, which encourages Federal agencies to ``identify 
and assess environmental health risks and safety risks that may 
disproportionately affect children'' and result from regulatory action.
    Response: The Administrator of FSIS has determined that the 
elimination of prior approval of nonfood compounds and proprietary 
substances will not have an adverse impact on the environment or human 
health, and therefore, that it is not necessary for FSIS to perform an 
environmental impact assessment for this action. As stated above, FSIS 
is continuing to require that meat and poultry products be neither 
adulterated nor misbranded through the use of proprietary substances 
and nonfood compounds and that the use of these substances and 
compounds must not create insanitary conditions. FSIS inspection 
program employees will verify that these chemicals are being used 
appropriately and are not adulterating product through inspection, 
review of documentation substantiating the safety of the chemicals, and 
if necessary, sampling and testing. Other Federal and state 
requirements concerning the use, storage, or disposal of these 
chemicals will not be affected by this rule. There is no reason to 
believe, therefore, that the discontinuation of the FSIS prior approval 
program for nonfood compounds and proprietary substances will allow 
meat and poultry establishments to use these chemicals in any manner 
that would have an adverse impact on human health and the environment.
    Finally, because FSIS has determined that this action will not have 
any significant impact on the environment or on human health, FSIS has 
similarly determined that this action will not have a 
disproportionately adverse impact on the health of children and is, 
therefore, consistent with the intent of E.O. 13045.

Denaturants

    During the course of reviewing the comments, FSIS discovered that 
it had not proposed to rescind in Secs. 314.3 and 381.95, which require 
establishments to use only prior approved denaturants for condemned 
meat and poultry, even though FSIS has listed approved denaturants in 
the List of Proprietary Substances and Nonfood Compounds. Denaturants 
are chemicals used to color or affect condemned meat and poultry 
products in a manner that readily identifies them as inedible to 
establishment employees and FSIS inspection program employees, so that 
the product will not be processed, shipped, or marketed as edible 
product. In the near future, FSIS will publish a proposal to rescind 
these prior approval requirements for denaturants and replace them with 
a performance standard. The standard that FSIS intends to propose will 
take into account FDA policy regarding denaturants applied to condemned 
meat and poultry products used for animal feed. Until the FSIS proposal 
is published and made final, the requirements regarding prior approval 
of denaturants will remain in effect.

Operational Sanitation: Proposed 416.4(d)

    Comment: Several commenters opposed the proposal to replace with a 
performance standard Sec. 381.47(e), which required that rooms where 
mechanical equipment is operated for the deboning of raw poultry be 
maintained at 50  deg.F or less. FSIS considered this requirement to be 
overly prescriptive and proposed to allow establishments to devise 
their own means for limiting microbial growth in their processing 
operations. Commenters claimed that the prescriptive temperature 
requirement is imperative for preventing microbial growth and contended 
that small establishments lack the resources and expertise to innovate 
in this area.
    Response: As stated in the proposal, in response to requests, FSIS 
has permitted many establishments to use methods other than reducing 
ambient temperature to control microbial growth in raw poultry. Several 
establishments have used heat-exchangers connected to the grinding 
equipment to bring about an immediate reduction in product temperature. 
Use of heat-exchangers on the equipment can more effectively reduce 
product temperature and limit growth of microorganisms than strict 
adherence to the requirement to maintain a specific room temperature. 
The performance standard for operational sanitation will allow 
establishments to devise their own means for limiting microbial growth 
in their processing operations, without requesting special approval 
from the Agency.
    Small establishments will not have to innovate in this area. If 
they choose, small establishments may continue to maintain the 
temperature in poultry deboning rooms at 50  deg.F. Since this measure 
has been proven to adequately control microbial growth in this 
processing situation, it will continue to meet the performance standard 
for operational sanitation, until new or better data suggest otherwise.
    Comment: Also in regard to operational sanitation, FSIS proposed 
the following performance standard: ``Product must be protected from 
contamination or adulteration during processing, handling, storage, 
loading, and unloading at and during

[[Page 56411]]

transportation from official establishments; ready-to-eat product must 
be protected from cross-contamination by pathogenic organisms.'' 
Several commenters argued that the standard regarding cross-
contamination of ready-to-eat product was redundant, unnecessary, and 
only an example of one kind of product adulteration. They requested 
that FSIS make final only the first, more general standard.
    Response: FSIS agrees that the proposed standard concerning cross-
contamination is redundant and thus, for clarity, will not finalize it. 
Establishments already are specifically required to prevent the cross-
contamination of ready-to-eat product by the first half of this 
proposed standard. FSIS also is revising this standard by removing the 
prohibition against product contamination, because, as explained above, 
such a standard is unnecessary.

Employee Hygiene: Proposed Sec. 416.5(a)

    Comment: Several commenters argued that the proposed performance 
standards for employee hygiene were too prescriptive. Specifically, 
these commenters objected to the proposed requirement that ``All 
persons working in contact with * * * product-packaging materials must 
adhere to hygienic practices while on duty to prevent adulteration of 
product.'' They maintained that insanitary contact with certain 
packaging materials, such as canned product shipping containers, could 
never lead to product adulteration. These commenters suggested that 
FSIS clarify that the standard only applies to ``product-contact-
packaging.''
    Response: Although the unhygienic handling of certain packaging 
materials that do not come in contact with product may not lead to 
direct contamination of the product contained therein, such handling 
could contribute to the creation of insanitary conditions within an 
official establishment. FSIS is revising the performance standard to 
reflect this concern. The finalized Sec. 416.5(a) states: ``All persons 
working in contact with product, food-contact surfaces, and product-
packaging materials must adhere to hygienic practices while on duty to 
prevent adulteration of product and the creation of insanitary 
conditions.''
    Comment: Conversely, several commenters opposed rescinding the 
existing regulatory prohibitions against specific, unhygienic employee 
activities and replacing them with performance standards. As discussed 
above in the ``General Opposition'' section, these commenters asserted 
that FSIS inspection program employees' enforcement authority will be 
weakened without specific prohibitions against such actions as 
``placing skewers, tags, or knives in the mouth'' (Sec. 308.8(e)). 
Further, these commenters cited multiple anecdotal examples of employee 
actions that could lead to the adulteration of product.
    Response: FSIS does not need to specifically enumerate every action 
by establishment personnel that could possibly lead to product 
adulteration or insanitary conditions. It would, in fact, be impossible 
to compile such a list of prohibited practices. FSIS program employees 
have always had the authority, and will continue to have the authority, 
to take action whenever establishment personnel fail to ensure that 
product is not adulterated or fail to maintain sanitary conditions, 
even if the problem identified is not specifically delineated in a 
regulation. This authority remains unchanged under the new performance 
standard for employee hygiene in Sec. 416.5(a).

Employee Clothing: Proposed Sec. 416.5(b)

    Comment: FSIS proposed a performance standard requiring that all 
employee outer clothing be readily cleanable. Several commenters from 
industry stated that their employees use disposable clothing, which is 
both sanitary and cost-effective, and requested that FSIS revise the 
standard to specifically allow for the use of disposable clothing.
    Response: FSIS agrees that disposable clothing can be appropriately 
sanitary and has revised the standard to read, in part: ``Aprons, 
frocks, and other outer clothing worn by persons who handle product 
must be of material that is disposable or readily cleaned.''

Employee Disease: Proposed Sec. 416.5(c)

    Comment: FSIS proposed a performance standard requiring that:

    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.

One commenter requested that the word ``illness'' be replaced with the 
word ``disease.''
    Response: FSIS agrees and has replaced the word ``illness'' with 
the phrase ``infectious disease.'' ``Illness'' is a general term that 
could describe a disease or condition that is not infectious and 
therefore would pose no risk of product adulteration. The phrase 
``contamination or'' also is removed for reasons explained above.

Tagging Insanitary Equipment, Utensils, Rooms or Compartments: Proposed 
Sec. 416.6

    Comment: In regard to tagging insanitary equipment, utensils, rooms 
or compartments, FSIS proposed that its inspection program employees 
take such action when they find ``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.'' 
Several commenters objected to the word ``unclean,'' arguing that it 
constituted a new standard and that its vagueness would lead to highly 
subjective enforcement by FSIS inspection program employees.
    Response: The proposed language is not new and, in fact, is almost 
identical to the previous tagging regulation, Sec. 308.15. 
Nevertheless, FSIS agrees that the regulation can be improved and for 
consistency with the sanitation requirements has replaced the word 
``unclean'' with the word ``insanitary.'' As stated above, under the 
FMIA and PPIA, FSIS must take action when an official establishment 
operates in a manner that leads to insanitary conditions and product 
adulteration. Accordingly, FSIS is revising the requirement to state 
that an FSIS inspection program employee will tag equipment, utensils, 
rooms, or compartments at an official establishment if they are 
``insanitary or [their] use could cause the adulteration of product.''

Custom Slaughter Establishments

    Comment: One commenter suggested that the proposed revisions to 
language exempting custom establishments from certain sanitation 
requirements were too restrictive, as they would apply only to custom 
slaughter operations and not to custom processing operations.
    Response: FSIS agrees. This error was unintentional and the 
exemption in Sec. 303.1(a)(2)(i) has been revised so as to apply to 
establishments ``that conduct custom operations,'' rather than only to 
``establishments conducting custom slaughter operations.''

Miscellaneous Changes

    In the proposal preceding this final rule, FSIS stated that it 
needed ``to revise all of the cross-references in the meat and poultry 
regulations to reflect the proposed deletion of Part 308 and 381 
Subpart H and the proposed addition of new Secs. 416.1 through 416.6.'' 
FSIS is making those revisions

[[Page 56412]]

in this final rule. References to specific sanitation requirements 
contained in sections of previous Part 308 or 381 Subpart H are 
replaced with references to the relevant sanitation performance 
standards in Part 416.
    FSIS also is making a few revisions to the regulations for 
consistency with the new sanitation performance standards. Although 
FSIS did not propose these specific revisions, they are necessary to 
avoid conflict within the meat and poultry inspection regulations. 
These changes will impose no new regulatory burden on establishments.
    First, Section 381.36(c)(1)(viii) of the poultry regulations states 
that ``Online handrinsing facilities with a continuous flow of water 
conforming to section 381.51(f) shall be provided for and within easy 
reach of each inspector and each establishment helper.'' Section 
381.51(f), which will be deleted by this final rule, stated:

    An adequate number of hand washing facilities shall be provided 
in areas where poultry products are prepared. Hand washing 
facilities accepted in accordance with the procedures set forth in 
section 381.53 may be used in such areas, provided that if hand-
activated facilities are used, the hand-contact element must be 
rinsed automatically with a sufficient volume of water to remove all 
fat, tissue, debris, and other extraneous material from the hand 
contact element after each use. Both hot and cold running water 
shall be available at each inspection station on the eviscerating 
line and shall be delivered through a suitable mixing device 
controlled by the inspector. Alternatively, water for hand washing 
shall be delivered to such inspection stations at a minimum 
temperature of 65 degrees F.

    Although FSIS is deleting from Sec. 381.36(c)(1)(viii) the 
reference to the deleted Sec. 381.51(f), it is not rescinding the 
requirements for hand washing facilities at inspection stations in 
official poultry establishments. The specific requirements for hand 
washing equipment and water temperatures previously contained in 
Sec. 381.51(f) are now contained in Sec. 381.36(c)(1)(viii). Similarly, 
in this final rule, although FSIS is replacing with a performance 
standard the prescriptive light intensity requirements for official 
poultry establishments (previous Sec. 381.52), it is not rescinding the 
specific light intensity requirements for inspector and reprocessing 
stations currently contained in Secs. 307.2 and 381.36. FSIS has 
determined that although official establishments are responsible for 
determining what light intensities and types of hand washing equipment 
are necessary to maintain sanitary conditions, the specific 
requirements for light intensities and hand washing facilities at 
inspection stations are still necessary to ensure appropriate 
conditions for effective inspection.
    Second, FSIS is revising the regulations in Secs. 314.2 and 314.4 
regarding the adulteration of edible meat and poultry product by 
inedible meat and poultry products. Specifically, FSIS is removing 
references to Part 308 and converting to performance standards 
prescriptive requirements regarding the prevention of product 
adulteration through contact with inedible product or odors from 
inedible product. These revisions are entirely consistent with the 
performance standards for establishment construction, operations, and 
the suppression of odors.

Elimination of Directives

    Comment: Several commenters objected to the proposed rescission of 
numerous FSIS Directives and Issuances concerning sanitation in 
official establishments, particularly FSIS Directive 11,000.1, the 
``Sanitation Handbook for Meat and Poultry Inspection.'' These 
commenters claimed that these Directives are needed by FSIS inspection 
program employees to ensure that establishments maintain adequate 
sanitation and do not adulterate product.
    Response: The FSIS Issuances and Directives in question are based 
upon the prescriptive sanitation regulations that are being rescinded 
and replaced by this rule. Therefore, retention of these documents 
would only generate conflict and confusion regarding the sanitation 
requirements official establishments must meet and how FSIS inspection 
program employees are to enforce these new requirements. For 
consistency with the HACCP and Sanitation SOP requirements and with the 
recent elimination of prior approval of establishment blueprints and 
equipment, FSIS already has rescinded the following Directives 
concerning sanitation (FSIS Notice 3-98; January 16, 1998):

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 11,520.2--Exposed Heat-Processed Products; Employee 
Dress

Further, in a forthcoming FSIS Directive concerning the new performance 
standards, FSIS will rescind these remaining Directives:

FSIS Directive 11,240.5--Plastic Cone Deboning Conveyors
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.  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
    As stated above, FSIS is issuing a new Sanitation Directive to 
accompany this rule. Although the Directive is written for FSIS 
inspector program employees, it will be available to the public. In 
addition, FSIS also will be issuing a compliance guide to assist 
establishments in complying with the new sanitation performance 
standards.

Compliance With Executive Order 12866 and the Regulatory Flexibility 
Act of 1996

    This 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.
    FSIS is revising and consolidating the sanitation regulations for 
official meat and poultry establishments, resolving unnecessary 
differences between similar rules for meat and poultry processing, and 
converting prescriptive requirements to performance standards. This 
action affects meat and poultry establishments subject to official 
inspection, custom exempt meat and poultry establishments, and 
consumers. In the proposal preceding this final action, FSIS requested 
comment concerning the potential economic effects of the proposed 
sanitation performance standards. FSIS specifically requested 
information that would allow the Agency to determine the number and 
kind of small entities that may incur benefits or costs resulting from 
issuance of this final rule.
    FSIS received no comments that specifically addressed this issue. 
However, several commenters opposed

[[Page 56413]]

to the proposed sanitation performance standards maintained that small 
meat and poultry establishments do not have the resources to innovate 
in order to take advantage of the flexibility provided by the 
performance standards. Further, these commenters argued that small 
establishments need prescriptive requirements to ensure that they know 
how to maintain sanitary conditions and produce safe, unadulterated 
products. FSIS disagrees. Establishments currently maintaining sanitary 
conditions may choose to continue their current practices and be 
assured that they will be found in compliance with the new performance 
standards. In addition, FSIS will be making available a compliance 
guide that will contain much of the information contained in previous 
sanitation regulations and Directives, to assist establishments of all 
sizes in meeting the new sanitation performance standards.
    In general, the streamlining, clarification, and consolidation of 
the sanitation regulations should benefit FSIS, the regulated industry, 
and consumers. User-friendly regulations employing performance 
standards simplify compliance and, therefore, should bring about food 
safety enhancements in individual establishments. Further, 
consolidation of the separate sanitation requirements for meat and 
poultry establishments and the consequent elimination of unnecessary 
inconsistencies will better ensure that enforcement policies are 
consistent and equitable and that competition is enhanced.
    The performance standards allow individual establishments to 
develop and implement customized sanitation procedures other than those 
currently mandated, as long as those procedures produce and maintain 
sanitary conditions that meet the performance standards. Establishments 
taking advantage of the performance standards to innovate may benefit 
from savings accrued through increased efficiency. Since the previously 
mandated sanitation procedures meet the performance standards 
established by this final rule, establishments may continue employing 
their current procedures. There is no discernable reason that 
establishments would incur any additional expenses as a result of this 
rule. As a matter of fact, FSIS anticipates that the adoption of these 
sanitation performance standards will present numerous opportunities 
for cost savings and believes that this rule will have a favorable 
economic impact on all establishments, regardless of size.
    It is difficult to quantify the potential benefits of the 
sanitation performance standards since it is not possible to predict 
exactly how many establishments will take advantage of the flexibility 
provided and develop innovative processes and how these innovations 
will reduce costs and increase efficiency. However, FSIS sees the 
potential for a more efficient use of resources by official 
establishments. 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 whether establishments maintain a sanitary environment in 
accordance with the Sanitation SOP requirements and these sanitation 
performance standards. This action should reduce demands on FSIS 
resources which could be redirected to functions more critical to 
improving food safety. FSIS anticipates that this restructuring of 
inspection, along with these performance standards and the HACCP, 
Sanitation SOP, and other food safety initiatives, will produce 
significant economic and societal benefits by reducing the incidence of 
food borne illness.
    In response to comments, FSIS is finalizing a new requirement in 
regard to the use of nonfood compounds and proprietary substances in 
Sec. 416.4(c): ``Documentation substantiating the safety of a 
chemical's use in a food processing environment must be available to 
FSIS inspection program employees for review.'' FSIS is not requiring 
that establishments make available any specific type of documentation 
since the specific documentation substantiating the safety of a 
chemical will almost certainly vary as to the nature and use of that 
chemical. Most, if not all, of the nonfood compounds and proprietary 
substances used by meat and poultry establishments already are sold 
with documentation substantiating their safety and efficacy. 
Pesticides, for example, have labels and documentation demonstrating 
registration with EPA; chemical sanitizers used on food contact 
surfaces often are accompanied by documentation, such as letters of 
guarantee, stating that the compound complies with the relevant FDA 
regulations in 21 CFR 178.1010. Therefore, FSIS has concluded that the 
finalized documentation requirement will place no new economic burden 
on the manufacturers or consumers of most of these compounds.
    FSIS recognizes that certain compounds, such as general cleaners 
and antislip agents, are not currently regulated or reviewed by any 
Federal agency and therefore may not be sold with documentation 
attesting to the safety and efficacy of their use in food processing 
establishments. Manufacturers will be compelled, therefore, to make 
such documentation available to their customers, if they are not doing 
so already. However, FSIS estimates that the economic impact of this 
requirement on these manufacturers will be minimal. Until the recent 
discontinuation of the FSIS prior approval program, these manufacturers 
had been required to supply FSIS with documentation attesting to the 
safety of their products. Now they will instead make this or similar 
documentation available to their customers. The paperwork burden of 
this new documentation requirement is discussed below under the section 
Paperwork Requirements. 
    As an alternative to the proposed sanitation performance standards, 
the Agency considered proposing more comprehensive and prescriptive 
sanitation regulations. The proposed requirements would then have 
included 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 types of food processing 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, because of the burden it would place on industry. The 
Agency believes 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 sanitation performance standards.
    FSIS already has established performance standards applicable to 
meat and poultry products, such as the Salmonella performance standard 
for raw carcasses and ground product established in the Pathogen 
Reduction/HACCP final regulation and the zero tolerance standard for 
fecal material on raw carcasses. Achieving these product-based 
performance standards depends on an establishment doing a number of

[[Page 56414]]

things correctly, including meeting the sanitation performance 
standards set forth in part 416.1 through 416.6. FSIS has concluded 
that because there are many methods and means through which 
establishments can ensure that products are not adulterated, FSIS will 
not prescribe exactly which methods, procedures, or means must be used.
    Finally, on the issue of whether there should be a list of specific 
prohibited practices retained in the regulations, FSIS has concluded 
that this is not necessary and that such a list could be misleading. 
Most of the prohibited practices that 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 by directly applying it to the 
surface of meat is only one of the means by which an establishment 
could be failing to prevent product adulteration. The Agency believes 
that a partial or outdated list of regulatory prohibitions in the 
regulations could be misconstrued to mean that anything not on the list 
is not prohibited. FSIS has concluded that it is better regulatory 
policy to communicate to industry examples of the types of practices 
that could result in insanitary conditions in guidance material.
    The other alternative available to FSIS was to maintain the 
previous sanitation requirements. However, as explained in detail 
above, these requirements were to an extent inconsistent with the 
principles of HACCP, needlessly reduced flexibility in accomplishing 
good sanitation, and may have substantially impeded innovation.

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 final rule on environmental and health conditions in 
low-income and minority communities.
    This rule consolidates the sanitation regulations for official meat 
and poultry establishments into a single part, eliminates unnecessary 
differences between the meat and poultry sanitation requirements, and 
converts many highly prescriptive requirements to sanitation 
performance standards. As explained in the economic impact analysis 
above, the new regulations should generally benefit FSIS, the regulated 
industry, and consumers. The regulations do not require or compel meat 
or poultry establishments to relocate or significantly alter their 
operations in ways that could adversely affect the public health or 
environment in low-income and minority communities. Further, this rule 
does 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.

Executive Order 12988

    This final rule has been reviewed under Executive Order 12988, 
Civil Justice Reform. States and local jurisdictions are preempted by 
the Federal Meat Inspection Act (FMIA) 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 and the PPIA. States and local jurisdictions may, 
however, exercise concurrent jurisdiction over meat and poultry 
products that are within their jurisdiction and outside official 
establishments for the purpose of preventing the distribution of meat 
and poultry products that are misbranded or adulterated under the FMIA 
and PPIA, or, in the case of imported articles, that are not at such an 
establishment, after their entry into the United States.
    This rule is not intended to have retroactive effect.
    Under this rule, administrative proceedings will not be required 
before parties may file suit in court challenging this rule. However, 
the administrative procedures specified in 9 CFR 306.5 and 381.35 must 
be exhausted prior to any judicial challenge of the application of the 
provisions of this rule, if the challenge involves any decision of an 
FSIS employee relating to any matters under the FMIA and the PPIA.

Paperwork Requirements

    Abstract: FSIS has reviewed the paperwork and recordkeeping 
requirements in this proposed rule in accordance with the Paperwork 
Reduction Act.
    Under the previous regulations, if meat and poultry establishments 
were cited for rodent or vermin infestation, FSIS required them 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,'' had approved 351 burden 
hours for this activity.
    This final rule eliminates 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 is requesting OMB to remove the 351 burden hours 
approved for the development of rodent and vermin infestation 
corrective action reports.
    Also, Sec. 416.2(g)(1) requires that establishments, upon request, 
make available to FSIS ``water reports issued under the authority of 
the State or local 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.''
    Finally, the Agency is adding a new information collection 
requirement in Sec. 416.4(c): ``Documentation substantiating the safety 
of a chemical's use in a food processing environment must be available 
to FSIS inspection program employees for review.'' FSIS is not 
requiring that establishments make available any specific type of 
documentation since documentation substantiating the safety of a 
chemical varies as to the nature and use of that chemical. Further, 
most, if not all, of the nonfood compounds and proprietary substances 
used by meat and poultry establishments already are sold with 
documentation substantiating their safety and efficacy. Nevertheless, 
manufacturers will be compelled to make such documentation available to 
their customers, if they are not doing so already. FSIS estimates that 
the impact of this requirement on these manufacturers will be quite 
minimal, since until the recent discontinuation of the FSIS prior 
approval program, these manufacturers had been required to supply FSIS 
with documentation attesting to the safety of their products.
    FSIS estimates that there are approximately 8,000 chemical 
manufacturers selling about 115,000 compound and substances to official 
meat and poultry establishments. There are approximately 6,186 official 
meat and poultry establishments. The following calculations were based 
upon the assumption that each chemical manufacturer sells, and each 
official establishment uses, an average of 14 compounds and substances.
    Estimate of Burden: The public reporting burden for this collection 
of

[[Page 56415]]

information is estimated to average 30 minutes for chemical 
manufacturers to provide documentation and 10 minutes for 
establishments to file the information.
    Respondents: Meat and poultry establishments and chemical 
manufacturers.
    Estimated Number of Respondents: 14,186.
    Estimated Number of Responses per Respondent: 14.
    Estimated Total Annual Burden on Respondents: 132,403 hours.
    Copies of this information collection assessment can be obtained 
from Lee Puricelli, Paperwork Specialist, Food Safety and Inspection 
Service, USDA, Cotton Annex Building, Room 109, Washington, DC 20250.
    Comments are invited on: (a) Whether the 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) or the Desk Officer for Agriculture, Office of 
Information and Regulatory Affairs, Office of Management and Budget, 
Washington, DC 20253.
    Comments are requested by December 20, 1999. To be most effective, 
comments should be sent to OMB within 30 days of the publication date 
of this final rule.

List of Subjects

9 CFR Parts 303, 304, and 307

    Meat inspection, Reporting and record keeping requirements.

9 CFR Part 308, 312, 314, 327,, 331, and 350

    Meat inspection.

9 CFR Part 381

    Poultry and poultry products inspection, Reporting and record 
keeping requirements.

9 CFR Part 416

    Sanitation.

    Accordingly, title 9, chapter III, of the Code of Federal 
Regulations is amended as follows:

PART 303--EXEMPTIONS

    1. The authority citation for part 303 continues to read as 
follows:

    Authority: 21 U.S.C. 601-695; 7 CFR 2.17, 2.55.

    2. Section 303.1 is amended by revising paragraph (a)(2)(i) to read 
as follows:


Sec. 303.1   Exemptions.

    (a) * * *
    (2) * * *
    (i) Establishments that conduct custom operations must be 
maintained and operated in accordance with the provisions of 
Secs. 416.1 through 416.6, except for: Sec. 416.2(g) (2) through (6) of 
this chapter, regarding water reuse and any provisions of part 416 of 
this chapter 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 of this chapter of shall apply to those 
operations.
* * * * *


Sec. 303.1  [Amended]

    3. In Sec. 303.1, paragraph (c), the second sentence is amended by 
removing the phrase ``in part 308 of this subchapter, except 
Secs. 308.1, 308.2, and 308.15'' and adding the phrase ``in part 416, 
Secs. 416.1 through 416.5 of this chapter'' in its place.

PART 304--APPLICATION FOR INSPECTION; GRANT OR REFUSAL OF 
INSPECTION

    4. The authority citation for part 304 continues to read as 
follows:

    Authority: 21 U.S.C. 601-695; 7 CFR 2.18, 2.53.


Sec. 304.2  [Amended]

    5. In Sec. 304.2(b), the first sentence is amended by removing the 
phrase ``308'' and adding the phrase ``Part 416, Secs. 416.1 through 
416.6 of this chapter'' in its place.

Part 307--FACILITIES FOR INSPECTION

    6. The authority citation for part 307 continues to read as 
follows:

    Authority: 7 U.S.C 394, 21 U.S.C. 601-695; 7 CFR 2.17, 2.55.

    7. Section 307.2 is amended by revising paragraph (l) to read as 
follows:


Sec. 307.2   Other facilities and conditions to be provided by the 
establishment.

* * * * *
    (l) Sanitary facilities and accommodations as prescribed by 
Secs. 416.2(c), (d), (e), (f), and (h) of this chapter.
* * * * *
    8. Section 307.3 is revised to read as follows:


Sec. 307.3  Inspectors to furnish and maintain implements in a sanitary 
condition.

    Inspectors shall furnish their own work clothing and implements, 
such as flashlights and triers, for conducting inspection and shall 
maintain their implements in sanitary condition as prescribed by 
Sec. 416.3(a) of this chapter.
    9. Section 307.7, paragraph (a), is revised to read as follows:


Sec. 307.7  Safety requirements for electrical stimulating (EST) 
equipment.

    (a) General. Electrical stimulating (EST) equipment is equipment 
that provides electric shock treatment to carcasses for the purpose of 
accelerating rigor mortis of facilitating blood removal. These 
provisions do not apply to electrical equipment used to stun and/or 
slaughter animals or to facilitate hide removal. Electrical stimulating 
equipment consists of two separate pieces--the control system and the 
applicator. The EST control system contains the circuitry to generate 
pulsed DC or AC voltage for stimulation and is separate from the 
equipment used to apply the voltage to the carcass. The voltage is 
applied by inserting a probe that penetrates the carcass or is inserted 
in the rectum, placing a clamp in the nose, a carcass rub-bar, a 
conveyor with energized surfaces traveling with the carcass, or any 
other acceptable method.
* * * * *

PART 308--[REMOVED AND RESERVED]

    10-11. Remove and reserve part 308, consisting of Secs. 308.1-
308.16.

PART 312--OFFICIAL MARKS, DEVICES AND CERTIFICATES

    12. The authority citation for part 312 continues to read as 
follows:

    Authority: 21 U.S.C. 601-695; 7 CFR 2.17, 2.55.

    13. In Sec. 312.6, paragraphs (a), and introductory text and (a)(3) 
are revised to read as follows:

[[Page 56416]]

Sec. 312.6  Official marks and devices in connection with post-mortem 
inspection and identification of adulterated products and insanitary 
equipment and facilities.

    (a) The official marks required by parts 310 and 416 of this 
chapter for use in post-mortem inspection and identification of 
adulterated products and insanitary equipment and facilities are:
* * * * *
    (3) The ``U.S. Rejected'' mark which is used to identify insanitary 
buildings, rooms, or equipment as prescribed in part 416, Sec. 416 of 
this chapter and is applied by means of a paper tag (Form MP-35) 
bearing the legend ``U.S. Rejected.''
* * * * *

PART 314--HANDLING AND DISPOSAL OF CONDEMNED OR OTHER INEDIBLE 
PRODUCTS AT OFFICIAL ESTABLISHMENTS

    14. The authority citation for part 314 continues to read as 
follows:

    Authority: 21 U.S.C. 601-695; 7 CFR 2.17, 2.55.

    15. Section 314.2 is revised to read as follows:


Sec. 314.2  Tanking and other facilities for inedible products to be 
separate from edible product facilities.

    All tanks and equipment used for rendering, otherwise preparing, or 
storing inedible products must be in rooms or compartments separate 
from those used for preparing or storing edible products. There may be 
a connection between rooms or compartments containing inedible products 
and those containing edible products as long as it does not cause the 
adulteration of edible product or create insanitary conditions.
    16. Section 314.4 is revised to read as follows:


Sec. 314.4  Suppression of odors in preparing inedible products.

    Tanks, fertilizer driers, and other equipment used in the 
preparation of inedible product must be operated in a manner that will 
suppress odors incident to such preparation which could adulterate 
edible product or create insanitary conditions.

PART 327--IMPORTED PRODUCTS

    17. The authority citation for part 327 continues to read as 
follows:

    Authority: 21 U.S.C. 601-695; 7 CFR 2.18, 2.53.


Sec. 327.6  [Amended]

    18. In Sec. 327.6, paragraph (e) is amended by removing the phrase 
`` 308.3, 308.4, 308.5, 308.6, 308.7, 308.8, 308.9, 308.11, 308.13, 
308.14, 308.15'' and adding the phrase ``416.1 through 416.6 of this 
chapter'' in its place.

PART 331--SPECIAL PROVISIONS FOR DESIGNATED STATES AND TERRITORIES; 
AND FOR DESIGNATION OF ESTABLISHMENTS WHICH ENDANGER PUBLIC HEALTH 
AND FOR SUCH DESIGNATED ESTABLISHMENTS

    19. The authority citation for part 331 continues to read as 
follows:

    Authority: 21 U.S.C. 601-695; 7 CFR 2.17, 2.55.

    20. Section 331.3, paragraph (c), is revised to read as follows:


Sec. 331.3  States designated under paragraph Sec. 301(c) of the Act; 
application of regulations.

* * * * *
    (c) Sections 416.2(c), (d), (e), (f), and (h) of this chapter shall 
apply to such establishments.
* * * * *

PART 350--SPECIAL SERVICES RELATING TO MEAT AND OTHER PRODUCTS

    21. The authority citation for part 350 continues to read as 
follows:

    Authority: 21 U.S.C. 1622, 1624; 7 CFR 2.17, 2.55.


Sec. 350.3  [Amended]

    22. Section 350.3, paragraph (a)(2) is amended by removing the 
phrase ``part 308'' and adding the phrase ``part 416, Secs. 416.1 
though 416.6 of this chapter'' in its place.

PART 362--VOLUNTARY POULTRY INSPECTION REGULATIONS

    23. The authority citation for part 362 continues to read as 
follows:

    Authority: 21 U.S.C. 1622, 1624; 7 CFR 2.17 (g) and (i), 2.55.


Sec. 362.2  [Amended]

    24. The second sentence of Sec. 362.2(a) is amended by removing the 
phrase ``subchapter C of this chapter'' and adding the phrase 
``subchapter A and subchapter E, part 416, Secs. 416.1 through 416.6 of 
this chapter'' in its place.

PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS

    25. The authority citation for part 381 continues 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.

    26. In Sec. 381.1, paragraph (b)(39) is removed.
    27. Section 381.36, is amended as follows:
    a. Paragraph (c)(1)(iv) is revised,
    b. Paragraph (c)(1)(vi), is amended by removing the phrase 
``complying with Sec. 381.53(g)(4) of this part'',
    c. Paragraphs (c)(1)(vii), (viii) and (x) are revised,
    d. In Paragraph (d)(1)(vi), the first sentence is amended by 
removing the phrase ``complying with Sec. 381.53(g)(4) of this part'',
    e. In paragraph (d)(1)(viii), the first sentence is amended by 
removing the phrase ``, notwithstanding the requirement of 
Sec. 381.52(b)'',
    f. Paragraph (d)(1)(xi) is revised,
    g. In paragraph (e)(1)(v), the first sentence is amended by 
removing the phrase ``complying with Sec. 381.53(g)(4)'', and
    h. Paragraph (e)(1)(ix) is revised.
    These revisions to Sec. 381.36 read as follows:


Sec. 381.36  Facilities required.

* * * * *
    (c) * * *
    (1) * * *
    (iv) Each inspector's station shall have a platform that is slip-
resistant and can be safely accessed by the inspector. The platform 
shall be designed so that it can be easily and rapidly adjusted for a 
minimum of 14 inches vertically while standing on the platform. The 
platform shall be a minimum length of 4 feet and have a minimum width 
of 2 feet; the platform shall be designed with a 42-inch high rail on 
the back side and with \1/2\-inch foot bumpers on both sides and front 
to allow safe working conditions. The platform must have a safe lift 
mechanism and be large enough for the inspector to sit on a stool and 
to change stations during breaks or station rotation.
* * * * *
    (vii) A minimum of 200-footcandles of shadow-free lighting with a 
minimum color rendering index value of 85 where the birds are inspected 
to facilitate inspection.
    (viii) Online handrinsing facilities with a continuous flow of 
water must be provided for and within easy reach of each inspector and 
each establishment helper. The hand-contact element must be rinsed 
automatically with a sufficient volume of water to remove all fat, 
tissue, debris, and other extraneous material from the hand contact 
element after each use. Both hot and cold running water shall be 
available at each inspection station on the eviscerating line and shall 
be delivered through a suitable mixing device controlled by the 
inspector. Alternatively, water for hand washing shall be delivered to 
such

[[Page 56417]]

inspection stations at a minimum temperature of 65 degrees F.
    (ix) * * *
    (x) Each inspection station shall be provided with receptacles for 
condemned carcasses and parts. Such receptacles shall comply with the 
performance standards in Sec. 416.3(c) of this chapter.
* * * * *
    (d) * * *
    (1) * * *
    (xi) Each inspection station shall be provided with receptacle for 
condemned carcasses and parts. Such receptacles shall comply with the 
performance standards in Sec. 416.3(c) of this chapter.
* * * * *
    (e) * * *
    (1) * * *
    (ix) Each inspection station shall be provided with receptacles for 
condemned carcasses and parts. Such receptacles shall comply with the 
performance standards in Sec. 416.3(c) of this chapter.
* * * * *


Secs. 381.45-381.61   (Subpart H)--Sanitation  [Removed and reserved]

    28. Remove and reserve Subpart H, consisting of Secs. 381.45--
381.61.
    29. Section 381.99 is 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

    30. The authority citation for part 416 continues to read as 
follows:

    Authority: 21 U.S.C. 451-470, 601-680; 7 U.S.C. 450; 7 CFR 2.18, 
2.53.

    31. Part 416 is amended by adding new Secs. 416.1 through 416.6, as 
follows:


Sec. 416.1  General rules.

    Each official establishment must be operated and maintained in a 
manner sufficient to prevent the creation of insanitary conditions and 
to ensure that product is not adulterated.


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 insanitary 
conditions, adulteration of product, or interfere with inspection by 
FSIS program employees. Establishments must have in place a 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 be applied or stored in a manner that will result in the 
adulteration of product or the creation of insanitary conditions.
    (b) Construction. (1) Establishment buildings, including their 
structures, rooms, and compartments must be of sound construction, be 
kept in good repair, and be of sufficient size to allow for processing, 
handling, and storage of product in a manner that does not result in 
product adulteration or the creation of insanitary conditions.
    (2) Walls, floors, and ceilings within establishments must be built 
of durable materials impervious to moisture and be cleaned and 
sanitized as necessary to prevent adulteration of product or the 
creation of insanitary conditions.
    (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, to the extent necessary to prevent product adulteration and the 
creation of insanitary conditions.
    (c) Light. Lighting of good quality and sufficient intensity to 
ensure that sanitary conditions are maintained and that product is not 
adulterated 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 control odors, vapors, and 
condensation to the extent necessary to prevent adulteration of product 
and the creation of insanitary conditions must be provided.
    (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 adulteration of product, water supplies, equipment, and 
utensils and prevent the creation of insanitary 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;
    (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; and
    (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 furnish FSIS with the letter of approval from 
that authority upon request.
    (g) Water supply and water, ice, and solution 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.). If an 
establishment uses a municipal water supply, it must make available to 
FSIS, upon request, a water report, issued under the authority of the 
State or local health agency, certifying or attesting to the potability 
of the water supply. If an establishment uses a private well for its 
water supply, it must make available to FSIS, upon request, 
documentation certifying the potability of the water supply that has 
been renewed at least semi-annually.
    (2) Water, ice, and solutions (such as brine, liquid smoke, or 
propylene glycol) used to chill or cook ready-to-eat product may be 
reused for the same purpose, provided that they are maintained free of 
pathogenic organisms and fecal coliform organisms and that other 
physical, chemical, and microbiological contamination have been reduced 
to prevent adulteration of product.
    (3) Water, ice, and solutions 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

[[Page 56418]]

contamination so as to prevent contamination or adulteration of 
product. Reuse that 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 
that 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 ensure 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 that 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, to 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 that 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 that would allow 
it to adulterate edible product or create insanitary conditions.
    (h) 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.
    (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 must be constructed and maintained in a 
manner that protects against the creation of insanitary conditions and 
the adulteration of product.


Sec. 416.3  Equipment and utensils.

    (a) 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 to ensure that their 
use will not cause the adulteration of product during processing, 
handling, or storage. Equipment and utensils must be maintained in 
sanitary condition so as not to adulterate product.
    (b) Equipment and utensils must not be constructed, located, or 
operated in a manner that prevents FSIS inspection program employees 
from inspecting the equipment or utensils to determine whether they are 
in sanitary condition.
    (c) Receptacles used for storing inedible material must be of such 
material and construction that their use will not result in the 
adulteration of any edible product or in the creation of insanitary 
conditions. Such receptacles 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 and sanitized as frequently as 
necessary to prevent the creation of insanitary conditions and the 
adulteration of product.
    (b) Non-food-contact surfaces of facilities, equipment, and 
utensils used in the operation of the establishment must be cleaned and 
sanitized as frequently as necessary to prevent the creation of 
insanitary conditions and the adulteration of product.
    (c) Cleaning compounds, sanitizing agents, processing aids, and 
other chemicals used by an establishment must be safe and effective 
under the conditions of use. Such chemicals must be used, handled, and 
stored in a manner that will not adulterate product or create 
insanitary conditions. Documentation substantiating the safety of a 
chemical's use in a food processing environment must be available to 
FSIS inspection program employees for review.
    (d) Product must be protected from adulteration during processing, 
handling, storage, loading, and unloading at and during transportation 
from official establishments.


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 adulteration of product and 
the creation of insanitary conditions.
    (b) Clothing. Aprons, frocks, and other outer clothing worn by 
persons who handle product must be of material that is disposable or 
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 adulteration of product and the creation of 
insanitary conditions.
    (c) Disease control. Any person who has or appears to have an 
infectious disease, 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 
adulteration and the creation of insanitary conditions until the 
condition is corrected.


Sec. 416.6  Tagging insanitary equipment, utensils, rooms or 
compartments.

    When an FSIS program employee finds that any equipment, utensil, 
room, or compartment at an official establishment is insanitary or that 
its use could cause the adulteration of product, he will attach to it a 
``U.S. Rejected'' tag. Equipment, utensils, rooms, or compartments so 
tagged cannot be used until made acceptable. Only an FSIS program 
employee may remove a ``U.S. Rejected'' tag.

    Done in Washington, DC on October 6, 1999.
Thomas J. Billy,
Administrator.
[FR Doc. 99-26983 Filed 10-19-99; 8:45 am]
BILLING CODE 3410-DM-P