Hazardous Waste Enforcement: U.S. Environmental Protection Agency and Easton, Maryland, Pharmaceutical Packaging Manufacturer Enter into Consent Agreement

Mitchell, Williams, Selig, Gates & Woodyard, P.L.L.C.

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The United States Environmental Protection Agency (“EPA”) and Aphena Pharma Solutions – Maryland, LLC (“APS”) entered into a February 16th Consent Agreement (“CA”) addressing certain alleged violations of the Maryland Hazardous Waste Regulations. See Docket No. RCRA-03-2021-0016.

The CA provides that APS operates a facility (“Facility”) in Easton, Maryland, whose operations include:

  • Chemical mixing
  • Blending and packaging of various types of liquids, creams, gels, suspensions, foams, and lotions
  • Manufacturing of hand sanitizers, vitamin B12, and nasal inhalers
  • Turnkey packaging, repackaging and manufacturing solutions for the pharmaceutical, dietary supplements, animal health, consumer health, and medical device markets

The Facility is stated to be a generator of solid waste and hazardous waste. It is further stated to be engaged in the temporary storage of certain waste in containers.

EPA is stated to have conducted a Compliance Evaluation Inspection (“CEI”) at the Facility on April 25, 2018. Further, EPA is stated to have sent a Request to Show Cause and Request for Information Letter to APS on December 4, 2019, providing the company an opportunity to furnish additional information relating to compliance with applicable hazardous waste regulation. Such information is stated to have been provided EPA subsequent to December 4, 2019.

The CA alleges the following violations:

  • Operating a Treatment, Storage or Disposal Facility Without a Permit or Interim Status
  • Failure to Keep Container of Hazardous Waste Closed
  • Failure to Provide Annual Hazardous Waste Training
  • Failure to Maintain an Adequate Contingency Plan

The CA assesses a civil penalty of $82,120.

A copy of the CA can be downloaded here.

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Mitchell, Williams, Selig, Gates & Woodyard, P.L.L.C.
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