subject: response to atp letter dated march 30, 2011 your ... · submitted in response to the...
TRANSCRIPT
rUNITED STATES ENVIRONMENTAL PROTECTION AGENCY
Ms. Elizabeth TannehillMason Chemical Company721 W. Algonquin RoadArlington Heights, IL 60005
MAY 201L
Subject: Response to ATP Letter dated March 30, 2011Marquat64-1010NEPA Registration No. 10324-147Your Submission Dated: June 28, 2011
Dear Ms. Tannehill,
We have completed a review of the new efficacy data for Staphylococcus aureus.submitted in response to the antimicrobial testing program (ATP) testing failure for this productagainst the organism named above.
Out of two lots tested both were positive (1+ of 60 for the test organism which isconsistent our performance standard of 0+ or T of 60). As a result, the data support a claim ofeffectiveness against Staphylococcus aureus for this product. No additional testing is required.
The revised labeling removing claims against Pseudomonas aeruginosa and removingdirctions for use in hospitals and institutions is acceptable subject to the comments listed below:
On page 2 revise the 5th paragraph in the left column to read: "this formulation isrecommended for use in public rest rooms...'Revise the PRECAUTIONARY STATEMENTS HAZARD TO HUMANS ANDDOMESTIC ANIMALS to read: "... Wash throughly with soap and water after handlingand before eating, drinking, chewing gum, using tobacco or using the toilet"'.On pages 2 and 3 under DIRECTIONS FOR USE delete the entire paragraph "Thisproduct is not be used as a terminal sterilant/high level disinfectant... .high leveldisinfection".
1.
4. On page 3 revise the section "KILLS HIV, HBV AND HCV ..." by deleting the phrase".. .in health care settings or other...".
A stamped copy of the revised label is enclosed. A copy of our efficacy review is also enclosed.
CONCURRENCES
SYMBOL k
SURNAME \
DATE \
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If you have any questions concerning this letter please contact Velma Noble at(703) 308-6233 or Emilia Oiguenblik at (703) 347-0199.
/elma NomeProduct Manager (31)Regulatory Management Branch IAntimicrobials Division (751 OP)
Attachments: Efficacy review, Stamped label
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