**EDWARDS-COUNCILOR CO., INC.**

Phone (757) 460-2401 *Manufacturing Chemists* Fax (757) 46406551

1427 BAKER ROAD

AIRPORT INDUSTRIAL PARK

VIRGINIA BEACH, VA 23455

April 22, 2003

Ms. Kathryn Boyle, Registration Division (7505C)

Office of Pesticide Programs

Environmental Protection Agency

1200 Pennsylvania Ave., N.W.

Washington, DC 20460-0001

Subject: Docket ID Number OPP-2002-0278

Comment on proposed regulation 40 CFR 180.940

Dear Ms. Boyle,

This comment is being submitted to you as you instructed in our recent
telephone conversation.

This comment on EPA's proposed sanitizing regulations, 40 CFR 180.940,
which is to replace FDA's regulation 21 CFR 178.1010, involves an
interpretation by many state and local health authorities regarding
their acceptance and rejection of certain quaternary sanitizers which
may be used within their area of jurisdiction. This interpretation
essentially rejects the use of those quaternary sanitizers listed under
21 CFR 178.1010 which are specified for use only up to or at a
concentration level of 200 ppm, and accepts those quaternary sanitizers
that are specified under 21 CFR 178.1010 as being effective within a
relatively broad concentration range of use up to a maximum of 400 ppm.

The concerns of public health officials regarding the use of chemical
sanitizers has evolved primarily since the passage of the Food Quality
Protection Act, when an emphasis was made on prohibiting harmful
pesticide residues that may result on food contact surfaces from
sanitizing solutions inaccurately prepared at higher concentration
levels than specified under 21 CFR 178.1010. The state and local health
inspectors and sanitarians that visit and evaluate public food service
establishments (restaurants, etc.) feel that sanitizer users
(dishwashers) may not always be relied upon to accurately prepare and
maintain their sanitizing solutions at a single precise concentration
level. Therefore, they believe that it is in the best interest of public
health to have sanitizers used that under 21 CFR 178.1010 are listed as
having a "broad use range concentration" which would provide the user a
"reasonable margin of error" in the preparation of safe and effective
sanitizing solutions. The only quaternary sanitizer active ingredient
listed under 21 CFR 178.1010 that is shown to have a broad use range
concentration of up to 400 ppm and provides the desired "reasonable
margin of error" sought by health authorities is the product composed of
a mixture of 60% di-n-alkyl dimethyl ammonium chloride and 40% alkyl
benzyldimethyl ammonium chloride. All of the other quaternary sanitizer
active ingredients listed under 21 CFR 178.1010 are only approved for
use up to or at the single specific use concentration level of 200 ppm,
and are therefore not considered acceptable for use by these health
authorities because they do not possess a "broad use range
concentration", which would provide the desired "reasonable margin of
error" for the user in their preparation of safe and effective
sanitizing solutions.

For state and local health authorities to properly comply with the Food
Quality Protection Act and FDA's regulation 21 CFR 178.1010, it
certainly seems reasonable that they would make the decision to take
action to restrict use of "200 ppm limit" quaternary sanitizers and
permit only the "broad concentration range 400 ppm limit" quaternary
sanitizers.

Manufacturers and distributors of sanitizing products having the
quaternary active ingredient that is approved under 21 CFR 178.1010 for
use up to 400 ppm are now very actively promoting their "reasonable
margin of error" advantage over competitive quaternary sanitizers that
are limited to use only at the 200 ppm level. They are also successfully
convincing more and more local health officials to restrict from use the
"200 ppm limit quaternary sanitizers" within their area of jurisdiction.

The first twenty or so sanitizers initially listed under 21 CFR 178.1010
specified use only at a single concentration level. As more sanitizers
were added to this regulation, FDA changed their procedure by specifying
the use of these newly listed active ingredients within relatively broad
use range concentration levels. These use ranges state the minimum
effective use level and also the maximum toxicologically safe level at
which the active ingredient can be used. The minimum and maximum use
range level was roughly a ratio of 1 (minimum level) to 2 (maximum
level). We have been told in the past by FDA that because all of the
quaternary sanitizer active ingredients listed under 21 CFR 178.1010 had
similar chemical and toxicological properties, that FDA intended to
approve all of these quaternary active ingredients for use up to 400
ppm.....unfortunately FDA never got around to accomplishing this. This
inequitable situation continues to exist as more and more local health
authorities restrict the use of "200 ppm limit quaternary sanitizers".

This writer feels that EPA has not been aware of this inequitable
situation concerning the "200 ppm limit" and "400 ppm limit" quaternary
sanitizers described above for several reasons. First, EPA's regulatory
authority over chemical sanitizers has not extended to the actual users
of these products (dishwashers in restaurants). Next, EPA has no direct
authority over state and local health officials who enforce the
regulations involving the use of chemical sanitizers and further, until
recently it was FDA's responsibility to change their regulation.

It is the purpose of this comment to request that the EPA take this
opportunity to approve all of the quaternary sanitizer solutions
currently listed under 21 CFR 178.1010 for use at the end use
concentration not to exceed 400 ppm of active quaternary compound. EPA
has ample toxicological data available from its own files to quickly
verify the toxicological safety of the 400 ppm concentration use limit
level for all of the quaternary compounds to be listed under 40 CFR
180.940. It should not require extensive time and expense involving the
submission and review of petitions for a tolerance exemption to
accomplish this task.

Please advise me of what action EPA may take in response to this
comment.

Yours truly,

William M. Edwards, President

Edwards-Councilor Co., Inc.