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04-2024-3507Administrative - FormalClosedFY 2024· Region 04

EPA v. Derma-Glove, LLC

Unilateral Administrative Order Without Adjudication

Case summary

1/3/2024: FIFRA NOTICE OF WARNING The inspection revealed that Derma-Glove appeared to sell and distribute the product Thyme to Clean. The product is marketed as a ?antibacterial wipe? which is marketed to be used on surfaces. Additionally, on January 3, 2024, a review was conducted of the Derma-Glove website (https://www.dermaglove.com/). It was found that Derma-Glove appears to sell and distribute another product, Surface Spray. The website states the product includes Clove Oil which is ?antimicrobial, antifungal, and antiviral.? Pursuant to 40 C.F.R. ? 152.25(f) certain ?minimum risk pesticides? are exempt from regulation under FIFRA if: (1) The product's active ingredients are only those listed in 40 C.F.R. ? 152.25(f)(1); (2) The product?s inert ingredients are only those listed in listed in 40 C.F.R. ? 152.25(f)(2)(i) through (iv); and (3) The product label meets other conditions of exemption set forth in 40 C.F.R. ? 152.25(f)(3), including 40 C.F.R. 152.25(f)(3)(ii), which requires that the pesticide product must not bear claims either to control or mitigate microorganisms that pose a threat to human health. The products Thyme to Clean and Surface Spray do not appear to qualify for exemption from registration under FIFRA as minimum risk pesticides, as the products make claims to control or mitigate microorganisms that pose a threat to human health, in apparent violation of the conditions of 40 C.F.R. ? 152.25. Based on a review of EPA records, it does not appear that Thyme to Clean nor Surface Spray are pesticides that have been registered with the EPA. Pursuant to Section 12(a)(1)(A) of FIFRA, 7 U.S.C. ? 136j(a)(1)(A), it is unlawful for any person in any State to sell or distribute to any person any pesticide that is not registered under Section 3 or whose registration has been cancelled or suspended. It appears that Derma-Glove is in violation of FIFRA Section 12(a)(1)(A), 7 U.S.C. ? 136j(a)(1)(A) for selling or distributing Thyme to Clean and Surface Spray, unregistered pesticides. The term ?label? is defined in Section 2(p) of FIFRA, 7 U.S.C. ? 136(p), to mean the written, printed, or graphic matter on, or attached to, the pesticide or device or any of its containers or wrappers. The term ?labeling? is defined in Section 2(p) of FIFRA, 7 U.S.C. ? 136(p), to mean all labels and all other written, printed, or graphic matter (a) accompanying the pesticide or device at any time; or (b) to which reference is made on the label or in literature accompanying the pesticide or device. The term ?antimicrobial pesticide? is defined in Section 2(mm) of FIFRA, 7 U.S.C. ? 136(mm), to mean a pesticide that is intended to disinfect, sanitize, reduce, or mitigate growth or development of microbiological organisms. Pursuant to Section 3 of FIFRA, 7 U.S.C. ? 136a, pesticides that are sold or distributed in the United States are required to be registered with the EPA. Pursuant to 40 C.F.R. ? 152.15, unless otherwise exempt, a substance is considered to be intended for a pesticidal purpose, and thus to be a pesticide requiring registration, if the person who distributes or sell the substance claims, states, or implies (by labeling or otherwise) that the substance can or should be used as a pesticide. Additionally, the substance is considered to be intended for a pesticidal purpose if the person who distributes or sells it has actual or constructive knowledge that the substance will be used, or is intended to be used, for a pesticidal purpose.

Defendants (1)

  • Derma-Glove, LLCNamed in settlement

Facilities (1)

  • DERMA-GLOVE, LLC

    3404 OAKCLIFF ROAD, SUITE C-3, DORAVILLE, GA, 30340

    Registry ID: 110071642395

Statutes cited

  • FIFRA 12A2LEstablishment Registration

Enforcement conclusions (1)

  • Derma-Glove, LLCentered 2024-01-03

    Primary law: FIFRA

Timeline (3 milestones)

  • 2024-01-03Final Order Issued
  • 2024-01-03Enforcement Action Closed
  • 2024-01-10Enforcement Action Data Entered

Case metadata

EPA activity ID
3603832659
Case number
04-2024-3507
Lead agency
EPA
EPA region
04
Voluntary self-disclosure
No
Primary statute
Establishment Registration

Sourced verbatim from EPA ECHO Enforcement Case Report for case 04-2024-3507 . Bulk data: ICIS-FEC download summary.

This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.