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Appendix B
Sanitation Performance Standards
The following are excerpts from FSIS Directive 11000.1 (FSIS, 2000~.
A. Grounds and Pest Control
1. What are the regulatory performance standards for grounds and pest control?
Section 416.2 (a) states that "The grounds about an establishment must be
maintained to prevent conditions that could lead to insanitary conditions, adul-
teration of product, or interfere with inspection by FSIS [Food Safety Inspection
Service] program employees. Establishments must have in place a pest manage-
ment program to prevent 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."
2. What do the performance standards mean?
Proper maintenance of the grounds about an establishment is essential for
ensuring good sanitation. However, establishments are responsible for preventing
sources of adulteration of product even if the cause of the adulteration originates
from conditions outside the designated boundaries of the establishment.
The pest management program does not have to be written.
294
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SANITATION PERFORMANCE STANDARDS
B. Construction
1. What are the regulatory performance standards for construction?
295
Section 416.2 (b) states: "~1) Establishment buildings, including their struc-
tures, 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 pre-
vent product adulteration and the creation of insanitary conditions."
2. What do these performance standards mean?
The establishment buildings must be sound and kept in good repair to pre-
vent insanitary conditions or the adulteration of product. Establishments cur-
rently maintaining sanitary conditions will not be required to make changes to
their construction or layout because of this performance standard. Establishments
can 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.
C. Light
1. What are the regulatory performance standards for lighting?
Section 416.2 (c) states that "Lighting of good quality and sufficient inten-
sity 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."
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296
APPENDIX B
2. What do the performance standards mean?
We have abolished the specific lighting requirements in the poultry regula-
tions and have combined the separate meat and poultry lighting requirements into
one performance standard. While we are giving establishments flexibility in
determining lighting requirements, lighting must be adequate in quality and well
distributed to allow for the monitoring of sanitary conditions and processing
conditions, and to examine product for evidence of adulteration.
D. Ventilation
1. What are the regulatory performance standards for ventilation?
Section 416.2 (d) states that "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."
2. What does the performance standard mean?
We do not expect that an establishment's ventilation will be able to com-
pletely eliminate all odors, vapors, and condensation but it must control them as
far as necessary to prevent adulteration of product or the creation of insanitary
conditions.
E. Plumbing and Sewage
1. What are the regulatory performance standards?
tained to:
a. Section 416.2 (e) states: "Plumbing systems must be installed and main-
(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."
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SANITATION PERFORMANCE STANDARDS
297
b. Section 416.2 (f) states that "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 requir-
ing approval by a State or local health authority, the establishment must furnish
FSIS with the letter of approval from that authority upon request."
2. What do the performance standards mean?
It is the responsibility of the establishment to ensure that plumbing and
sewage systems provide an adequate supply of potable water and remove waste
and sewage from the establishment without adulterating product or creating
insanitary conditions.
F. Water Supply and Water, Ice, and Solution Reuse
1. What are the regulatory performance standards for water supply and water,
ice, and solution reuse?
Section 416.2 (g) states: "~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 to chill or wash raw product may be reused for
the same purpose provided that measures are taken to reduce physical, chemical,
or microbiological contamination so as to prevent contamination or adulteration
of product.
Reuse that 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 waste water treatment facility may be used on
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298
APPENDIX B
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)(l) of this section. Product,
facilities, equipment, and utensils coming in contact with this water must undergo
a separate final rinse with nonreconditioned water that meets the criteria pre-
scribed in paragraph (g)(l) 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)(l) 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."
2. What do the performance standards mean?
The water performance standard makes transparent the current requirement
that potable water comply with EPA's [Environmental Protection Agency]
National Primary Drinking Water regulations. Certifications of water potability
provided by the 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 does not require testing for these water sources. Usually the state or
local governments do not test the wells for potability. Most establishments can
obtain the needed documentation from private laboratories. The regulations require
that documentation certifying the potability of water from private systems be
renewed at least semi-annually. Establishments can reuse water in a manner that
will neither adulterate product nor create insanitary conditions. FSIS permitted
under the old regulations certain uses of nonpotable water. 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. 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.
In many cases establishments will document and monitor water reuse activi-
ties as part of their HACCP [Hazard Analysis and Critical Control Point] plans
(See 417.2), because the water treatments or conditioning will eliminate or reduce
hazards they have determined would be otherwise reasonably likely to occur. The
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SANITATION PERFORMANCE STANDARDS
299
requirements that water be reused only "for the same purpose" refers to whether
water is reused for processing ready-to-eat or not ready-to-eat products; it does
not prohibit the reuse of water for different processes. For example, an establish-
ment could reuse poultry chiller water in a scalding tank. An establishment could
not, however, reuse poultry chiller water for cooking or cooling packaged ready-
to-eat product.
G. Dressing RoomlLavatory
1. What are the regulatory performance standards for dressing rooms and
lavatories?
a. Section 416.2 (h) states: "~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 com-
partments 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 establish-
ment 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."
2. What do the performance standards mean?
OSHA [Occupational Safety and Health Administration] has always had
standards for lavatories in their regulations (29 CFR 1910.141~. These standards
should be followed when establishments are constructed. FSIS will no longer
dictate the number of lavatories required. Lavatory facilities need to be main-
tained by the establishment in good repair and in a sanitary manner.
H. EquipmenWtensils
1. What are the regulatory performance standards for equipment and utensils?
a. Section 416.3 states: "(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. Equip-
ment and utensils must be maintained in sanitary condition so as not to adulterate
product.
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300
APPENDIX B
(b) Equipment or 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."
2. What do the performance standards mean?
Establishments have the flexibility to choose whatever method they want to
clean utensils and equipment to ensure that they are maintained in sanitary condi-
tion so as not to adulterate product. We have eliminated the requirement that
utensils and equipment used to dress diseased meat carcasses be cleaned with
either 180 degree F water or an approved disinfectant. FSIS no longer requires a
specific method for the cleaning of utensils and equipment used to dress diseased
meat carcasses, although they must still be maintained in a sanitary condition.
I. Sanitary Operations
1. What are the regulatory performance standards for sanitary operations?
Section 416.4 states: "(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 chemi-
cals 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." (In most cases the documen-
tation will be "Material Safety Data Sheet." You do not keep these documents in
your office files.)
(d) "Product must be protected from adulteration during processing, handling,
storage, loading, and unloading at and during transportation from official estab-
lishments."
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SANITATION PERFORMANCE STANDARDS
2. What do the performance standards mean?
301
Usually, an establishment cleans up its operations once a day; however,
some establishments have for some time conducted chemical cleanup procedures
less than once a day. Currently, establishments may use extended cleanup proce-
dures without prior approval of FSIS. FSIS expects an establishment to incorpo-
rate extended cleanup procedures into its Sanitation SOPs [Standard Operating
Procedures] (See 416.12~. To ensure that extended cleanup procedures prevent
insanitation and the adulteration of product, most establishments will probably
conduct microbiological and chemical sampling that evaluates the effectiveness
of the extended cleanup. The establishment's Sanitation SOPs records would
include the microbiological and chemical data that distinguish acceptable sani-
tary conditions from marginal or unacceptable sanitary conditions. (See 416.14~.
During the normal course of an establishment's operations meat and poultry
products should not come in contact with non-food contact surfaces. Still if non-
food contact surfaces are not properly cleaned and sanitized, insanitary condi-
tions could result, leading to the potential adulteration of product. We have
discontinued approving all nonfood compounds and proprietary substances before
use in official meat and poultry establishments. We are continuing to require that
meat and poultry products be neither adulterated nor misbranded through the
misuse of proprietary substances and nonfood compounds.
Documentation substantiating the safety of a chemical's use in a food-
processing environment must be available for your review. The documentation
will vary with the nature and intended use of that chemical. For example, for a
pesticide, an establishment should have documentation showing that the com-
pound 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 regulations in 21 CFR 178.1010. (Sanitizers meeting this
requirement are usually identified as "Food Grade.")
Meat and poultry establishments are responsible for ensuring that all propri-
etary substances and nonfood compounds are safe for their intended use and used
appropriately.
Establishments are free to choose whatever scientifically supportable method
they find effective in limiting microbial growth in their operations.
J. Employee Hygiene
1. What are the regulatory performance standards for employee hygiene?
Section 416.5 states: "(a) Cleanliness. All persons working in contact with
product, food-contact surfaces and product-packaging materials must adhere to
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302
APPENDIX B
hygienic practices while on duty to prevent adulteration of product and the cre-
ation 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 opera-
tions which could result in product adulteration and the creation of insanitary
conditions until the condition is corrected."
2. What do the performance standards mean?
Specific types of unhygienic practices have been removed from the regula-
tions. You continue to have the authority to take action against any unhygienic
practice that could result in insanitary conditions or adulterated product.
K. Custom Exempt Facilities
1. What are the regulatory performance standards for custom exempt facilities?
Section 303.1 (2) (i) states: "Establishments that conduct custom operations
must be maintained and operated in accordance with the provisions of §§ 416.1
through 416.6, except for § 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 shall apply to those operations."
2. What does the performance standard mean?
Custom exempt facilities must comply with the sanitation performance stan-
dards except for sections 416.2 (g) paragraphs (1) through (6) about water reuse.
The establishment conducting custom exempt/retail exempt activities should also
operate in accordance with time/space separation and adequate procedures to
ensure that product does not bear the mark of inspection.
REFERENCE
FSIS (Food Safety and Inspection Service). 2000. FSIS Directive 11000.1 Sanitation Performance
Standards. Online. U.S. Department of Agriculture. Available at http://www.fsis.usda.gov/
OPPDE/rdad/FSISDirectives/FSISDirl 1000. l.pdf. Accessed May 15, 2002.
Representative terms from entire chapter:
regulatory performance
