Under
the provisions of HFS 196, Appendix 7-204.11, Wisconsin Administrative Code,
restaurant regulations, the Department may approve chemical sanitizing solutions
and specify the concentration.
Also, routine sanitization is required for all milk-contact surfaces
encountered on farms and in our dairy processing plants. Because there are a variety of such
agents, other than sodium or calcium hypochlorite, held forth and sold as
sanitizing agents, it has become necessary to establish procedures whereby such
chemicals can be analyzed and evaluated.
Accordingly, arrangements have been made with the Wisconsin State
Laboratory of Hygiene, Sanitizer Testing Program, 2601 Agriculture Drive,
Madison, Wisconsin 53707, (608) 224-6230, or the NSF International Testing
Laboratory, 789 Dixboro, P. O. Box 130140, Ann Arbor, Michigan 48113-0140, (734)
769-8010, to make efficacy tests for companies manufacturing or distributing
sanitizers in Wisconsin, the cost of such test, original as well as retest, to
be borne by such manufacturer or distributor. To have a product tested for approval by
the Division of Public Health, the manufacturer or distributor must make
financial arrangements with the indicated laboratories and then write the
Division of Public Health, Environmental Sanitation Section, P. O. Box 2659,
Madison, Wisconsin 53701-2659, giving the name of the product to be tested and
the name and address of a jobber in Wisconsin where a sample may be
procured.
The
general procedures set forth by the Department on evaluation of sanitizers for
all who intend to participate in this program are as
follows:
I.
LABORATORY
TESTING
A)
Germicidal and Detergent Sanitizers Test (current edition of
AOAC)
1)
Summary of Procedure:
The
AOAC protocol provides for the testing of the sanitizer against Escherichia
coli and/or Staphylococcus aureus using 30 and 60 second exposure
periods and water having a hardness of 500 ppm synthetic hard
water.
2)
Standard of Effectiveness:
Results of the test, to be considered satisfactory, must show a 99.999%
reduction in the number of viable organisms within 30 seconds in 500 ppm
synthetic hard water. The challenge
level of bacteria must be between 75- 125 X 106
CFU/ml.
B)
Available Chlorine Germicidal Equivalent Concentration Test (ACGECT)
(current
edition of the AOAC):
1)
Summary of Procedure:
The
test provides for a comparison ability of the sanitizer prepared in 500 ppm
synthetic hard water to kill Staphylococcus aureus as compared to the
ability of a standard sodium hypochlorite solution to kill the
organism.
2)
Standard of Effectiveness:
Results
of the ACGECT, to be considered satisfactory, must show equivalent disinfecting
activity to 100 ppm available chlorine.
The germicide tested must show absence of growth in as many consecutive
tubes of the subculture tube series as the 100 ppm available chlorine control
solution.
C)
Quality Assurance
1)
Germicidal and Detergent Sanitizer Test
A
positive and negative response must be demonstrated using a compound with known
response characteristics. The
compound used must pass at 500 ppm and fail at 900 ppm hardness when prepared
according to manufacturer directions with 500 ppm and 900 ppm SHW. When testing
quaternary compounds, the control must be a quaternary ammonia
compound.
2)
ACGECT
The
test must show a response of at least one negative increment with 50 ppm NaOCl
and at least one positive increment with 200 ppm NaOCl.
D)
Requirements for Approval
Product
must prove effective in one of the following three ways. The intent of this requirement is to
provide testing of the sanitizer against both a gram positive and a gram
negative organism.
1)
The product must meet the standard of effectiveness using both E.
coli and S. aureus in the Germicidal and Detergent Sanitizer Test,
or
2)
The product must meet the standard of effectiveness using E. coli in the
Germicidal and Detergent Sanitizer Test and S. aureus in the ACGECT,
or
3)
The product must meet the standard of effectiveness using
S. aureus in the Germicidal & Detergent Sanitizer Test, and
S. typhi in the ACGECT.
II.
METHOD OF PRODUCT
SUBMISSION
Samples
will be selected by authorized representatives of the Division of Public Health
from unbroken containers in the hands of a Wisconsin jobber and forwarded
directly to the laboratory, or products not on the market can be sent directly
to the laboratory. The person
submitting the product must advise the laboratory to forward copies of the test
result to both the Division of Public Health and to the manufacturer or
distributor or other person supplying the product. For products submitted directly to the
laboratory, the Division of Public Health reserves the right to pick up a sample
for testing when the product is marketed in Wisconsin.
Because
of budget constraints in the Department of Health and Family Services for the
operation of this program, please make arrangements for a free sample,
preferably in the original container, for testing at the location you select for
the Department staff to pick up a sample.
III. TEST REQUIREMENTS
A)
Product Not Previously Tested for Which Approval is
Requested:
If a chemical formulation has not been previously
tested for approval, the product must be tested by either the Wisconsin State
Laboratory of Hygiene or the National Sanitation Foundation Testing
Laboratory.
B)
Products Modified After Initial Test to Increase
Effectiveness:
Products
previously tested and approved under the Division's program and subsequently
modified to increase their effectiveness must be retested for continued
approval.
C)
Products Modified After Initial Test by Reduction of Active
Ingredients:
Products
previously tested and approved under the Division's program and subsequently
modified by reduction of the concentration of the sanitizer or decrease in the
amount of wetting or sequestering agents are required to be
retested.
D)
Packaging for Another Concern:
If a wholesaler or compounder does the packaging for another concern and
certifies that the material contained in the sanitizer marketed under a
different name is identical with the original compound satisfactorily submitted,
tested and approved, no further test will be required of the material marketed
under the different name.
E)
Approved Sanitizer Packaged by Other than the Original
Compounder:
If
a company packages a sanitizer which is certified as identical with an original
compound submitted, tested and approved, testing of the product having a label
different than the original approved sanitizer is
required.
F)
Periodic Retesting:
Periodic
retesting of all sanitizers other than inorganic hypochlorites will be required
approximately every 3 years. The
retest must show effectiveness against both organisms. In the event the test fails to show such
effectiveness, the following will apply:
1)
The Division will immediately contact the manufacturer by letter or phone
to determine:
a)
Whether the manufacturer decides to authorize the laboratory to perform
another test in which case the Division's representative will submit a second
sample from an unbroken container directly to the laboratory performing the
original retest.
b)
Whether the manufacturer wishes to remove the sanitizer from the market
in which case all parties concerned will be immediately notified of the
deletion.
2)
If the follow-up retest fails to show effectiveness against both
organisms, the product will be removed from the approved marketed sanitizer
list. All parties concerned will be
immediately notified of the deletion.
IV. PUBLICATION
A)
Notice to Manufacturer:
The
manufacturer will be advised of approval or disapproval of the product
submitted.
B)
Publishing and Distribution of Approved List of
Sanitizers:
The
Division will publish a listing of approved sanitizers. Copies of the listing will be mailed
to:
1)
Health departments which act as agents of the Division under the
restaurant program.
2)
Members of the Interstate Milk Conference and Grade A Supervisory
Agencies.
3)
Environmental Sanitation Sanitarians and Milk Rating Officers, Division
of Public Health.
4)
All manufacturers and distributors participating in the
program.
5)
State Department of Agriculture, Trade and Consumer
Protection.
V.
LABELING
A)
Registered and Approved:
The
State Department of Agriculture, Trade and Consumer Protection requires that all
sanitizers be registered and their labels be approved on an annual basis as of
January 1 of each year.
B)
Directions for Use in Eating Establishments:
All
sanitizers shall have indicated on the product label the directions for
sanitizing multi-use eating and drinking utensils. These directions shall be printed in a
numbered outline form as follows (five steps):
1)
Scrape and pre-wash utensils and glasses whenever
possible.
2)
Wash with a good detergent or compatible cleaner (a commercial cleaner or
detergent can be recommended).
3)
Rinse with clean water.
4)
Sanitize in a solution of _____ ounces to _____ gallons of water (_____
ppm). Immerse all utensils for at
least two minutes or for contact time specified by governing sanitary
code.
5)
Place sanitized utensils on a rack or drainboard to air
dry.
NOTE: A clean potable water rinse following
sanitization is not permitted under HFS 196, Appendix 7-204.11 of the Wisconsin
Administrative Code (reference 21 CFR 178.1010 (a)).
C)
Requirements of the Wisconsin Conference on Interstate Milk
Shipments:
The
conference has no special labeling requirements at this
time.
D)
Approval Statement:
Manufacturers
of approved products will be permitted to use the statement on their label that
their product was "Approved under the regulations of the Wisconsin State
Division of Public Health".
