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USDA Letter About
BioShield® 75
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the original PDF version here
August 2, 2006
Mr. Joeseph E. Mason, President
IndusCo, LTD
2319 Joe Brown Drive
Greensboro, NC 27405
This is a response to your
notification (Log 06-NT 0215-N-A) dated
June 9, 2006, requesting approval of BioShield
75 to be used in any Food Safety Inspection
Services (FSIS) establishments as a sanitizing
agent.
On July 18, 2006, representatives
from Indusco met with the Food Safety and
Inspection Service (FSIS) to present their
technology and request a letter of "no
objection" for the use of BioShield
75 solution on federally inspected establishments
as a sanitizing agent. BioShield 75 is a
stable aqueous solution of Organosilane
Quaternary Ammonium that is intended to
be applied to food contact and non-food
contact materials, e.g., floors, drains,
tables, cutting boards, slicers, etc., followed
by a wash and rinse.
BioShield 75 has strong
bonding capabilities upon application to
various materials. Thus, the use of BioShield
75 results in a durable coating that is
effective in eliminating and preventing
growth of bacteria, mold, and fungi. BioShield
75 is registered with the Environmental
Protection Agency (EPA).
FSIS has completed its
review of the information submitted supporting
BioShield 75 as a sanitizing agent and has
no objection to the use of BioShield 75
as FSIS regulated establishments as a sanitizing
agent. This letter should not be considered
as validation that BioShield 75 will be
effective in any particular FSIS establishment.
On October 20, 1999, USDA
published in the Federal Register, a Final
Rule entitled "Sanitation Requirements
for Official Meat and Poultry Establishment".
This rule consolidates the sanitation regulations
into a single part applicable to both official
meat and poultry plants, eliminates unnecessary
differences between the sanitation requirements
for meat and poultry processing, and converts
many of the highly prescriptive sanitation
requirements to performance standards. Among
the prescriptive sanitation requirements
that were eliminated was the regulation
(Title 9, Code of Federal Regulations (CFR),
Section 381.60) requiring the authorization
of non-food compounds by USDA, prior to
their use in a Federally inspected meat
or poultry establishment. The new sanitation
regulations (9 CFR, Section 416.4) state
that non-food compounds and processing aids
used by an establishment must be safe and
effective under the conditions of use.
The establishment must
have documentation on file substantiating
the safety of a chemical's use in a food
processing environment and this documentation
must be available to FSIS inspection program
employees for review. The documentation
may be in teh form of a manufacturer's or
supplier's letter of guaranty or a third
party authorty's certification that the
compound is safe according to some established
safety criteria and, as proposed for use
will have no deleterious effects on meat
and poultry being processed. A manufacturer's
or supplier's letter of guaranty should
contain the following information: 1) name
and address of the supplier; 2) brand name,
code name, or other designation; 3) statement
of safety and efficacy; 4) statement of
compliance with U.S. Federal regulations
(if applicable); 5) use directions; and
6) signature of an authorized firm representative.
FSIS does not object to
the proposed use of BioShield 75 to treat
food contact and non-food contact materials
in meat and poultry establishments. Those
establishments, who use BioShield 75, are
to be supplied with the following information:
- Information to
support the safety of the product when
in contact with BioShield 75 solution
in food processing environments.
- Copy
of EPS's registration Certificate
If you have any further
questions, please contact Dr. Kris Murthy
at (202) 690-5646 or kris.murthy (at) fsis.usda.gov.
Sincerely,
Patricia S. Schwartz, Ph.D.
Acting Director, New Technology Staff
Office of Policy, Program, and Employee
Development
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