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Enforcement

Stop Sale, Use, or Removal and Modification of the Order issued to sBioMed, LLC

On September 11, 2015, EPA issued an order to sBioMed, LLC, directing the company to immediately stop the sale, use, or removal of Steriplex SD Part A and Steriplex SD Activator Part B, which at that time were registered pesticide products marketed as effective, when combined, against Clostridium difficile, or C. diff, which is a bacterium that can cause symptoms ranging from diarrhea to life-threatening inflammation of the colon. The order was issued after sample products that were provided by a hospital were tested by EPA, and the results showed that the products were ineffective against C. diff.

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Company and Pesticide Overview

sBioMed, LLC, is a corporation based in Utah that produces, distributes, sells, and is the registrant of Steriplex SD Part A (EPA Reg. No. 84545-11) (“Part A”) and Steriplex SD Activator Part B (EPA Reg. No. 84545-10) (“Part B”). These products are sold by distributors to end users in hospitals and other facilities around the country. The products’ EPA registrations in 2015 provided that Part A and Part B, when combined in accordance with label directions, create a disinfectant effective as a sporicide against Clostridium difficile, or C. diff.

The accepted labels of each product stated that the active ingredients in Part A is Silver (0.015 percent), and in Part B are Hydrogen Peroxide (22 percent) and Peroxyacetic Acid (15 percent). Among other claims, the approved labels of Part A and Part B stated that when combined, the product “kills Clostridium difficile spores in five minutes” and is “an effective C. diff sporicide” “for hospital use.”

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Basis for the Order

In August 2015, an EPA laboratory in Maryland began efficacy testing of samples of Part A and Part B that were provided by a hospital that had been using the products. The tests of liquid and spray formulations of Steriplex SD (Part A and Part B combined), using the appropriate testing standards, showed that the products were not effective against C. diff when used as directed at a contact time of five minutes. A second round of testing samples of the product sent by the manufacturer yielded the same results.

Under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), it is unlawful to sell or distribute a misbranded pesticide. Because the testing showed that the representations in the labels of Part A and Part B, specifically as they claimed efficacy against C. diff, are false and misleading, EPA had reason to believe that sBioMed distributed or sold pesticides that were misbranded, as that term is defined by section 2(q)(1)(A) of FIFRA, 7 U.S.C. § 136(q)(1)(A), in violation of section 12(a)(1)(E) of FIFRA, 7 U.S.C. § 136j(a)(1)(E).

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Summary of the Order

Section 13(a) of FIFRA, 7 U.S.C. § 136k(a), authorizes EPA to issue a “Stop Sale, Use, or Removal Order” to persons with a pesticide in their ownership, custody, or control whenever there is reason to believe that such pesticide is in violation of any provision of FIFRA, or that such pesticide has been or is intended to be distributed or sold in violation of any provision of FIFRA.

Pursuant to this authority, EPA ordered sBioMed, LLC, to immediately stop the sale, use, or removal of Steriplex SD Part A and Steriplex SD Activator Part B under its ownership, control or custody, wherever such products are located. The Order also prohibited sBioMed, LLC, from using, selling, offering for sale, holding for sale, shipping, delivering for shipment, moving or removing for disposal from any facility or establishment, the subject products for any reason, unless approved by EPA in writing.

The Stop Sale, Use, or Removal Order shall remain in effect unless and until revoked, terminated, suspended or modified in writing by EPA.

More information on the use of Stop Sale, Use, or Removal Orders.

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Modification of the Order

On September 18, 2018, EPA’s Office of Pesticide Programs accepted sBioMed, LLC’s amendments to the registrations of the products subject to the Order and identified by EPA Reg. Nos. 84545-10 and 84545-11. The labels accepted as part of the amended registrations no longer feature claims of effectiveness against C. diff.

On October 16, 2018, EPA modified the September 11, 2015 Order to permit the sale and distribution of the products identified by EPA Reg. Nos. 84545-10 and 84545-11, provided the products are labeled and formulated consistent with their amended registrations. The terms of the original Order remain in effect with respect to any stocks identified by EPA Reg. Nos. 84545-10 and 84545-11 that are misbranded.  A copy of EPA’s letter modifying the Order can be accessed at the link above.

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For more information, contact:

Adrienne Trivedi
U.S. Environmental Protection Agency
1200 Pennsylvania Avenue NW (MC 2249A)
Washington, DC  20460
(202) 564-7862
trivedi.adrienne@epa.gov

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