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03-2019-8000Administrative - FormalFinal Order IssuedFY 2019· Region 03

EPA v. DENTSPLY LLC (DENTSPLY LLC, DBA SULTAN HEALTHCARE)

Final Order No Penalty

Case summary

On November 15, 2018, LCD issued a Denial of Entry is informing the U.S. Customs and Border Protection (CBP) that the product in the import shipment described under Entry Number 916-37754101 was denied entry into the United States (19 CFR 12.114) via the CBP Automated Commercial Environment (ACE) Portal. Dentsply, LLC. was importing five (5) unregistered pesticides, Zeta 5 Power Act, Zeta 3 Foam , Zeta 3 Soft , Zeta 3 Wipes Total , and Zeta 3 Wipes Pop-up , for research and development ( R&D ) purposes. EPA requires importers of unregistered pesticides for R&D to have certain information on the product label including the statement Not for Sale , For Research and Development Purposes Only so as to ensure that the unregistered pesticides do not enter the stream of commerce. This label did not meet EPA's requirements. Pursuant to the authority of Section 17(c) of FIFRA, 7 U.S.C. 136o(c), and the regulations at 19 C.F.R. 12.114, EPA rejected the entry of this product for import into the United States.

Defendants (1)

  • DENTSPLY LLC,Named in settlement

Facilities (1)

  • DENTSPLY LLC, DBA SULTAN HEALTHCARE

    1301 SMILE WAY, YORK, PA, 17404

    Registry ID: 110070499280

Statutes cited

  • FIFRA 12A1AUnregistered Pesticide

Enforcement conclusions (1)

  • DENTSPLY LLC (DENTSPLY LLC, DBA SULTAN HEALTHCARE)entered 2018-11-19

    Primary law: FIFRA

Timeline (2 milestones)

  • 2018-11-19Final Order Issued
  • 2018-12-19Enforcement Action Data Entered

Case metadata

EPA activity ID
3601703584
Case number
03-2019-8000
Lead agency
EPA
EPA region
03
Voluntary self-disclosure
No
Primary statute
Unregistered Pesticide

Sourced verbatim from EPA ECHO Enforcement Case Report for case 03-2019-8000 . 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.