[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difficult to understand, redundant, or outdated.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
