Paeffgen, Elise N.

Elise N. Paeffgen

Partner,
Clients depend on Elise to navigate EPA, FDA, and DEA regulations and to guide them through environmental enforcement actions. Elise has significant experience in cross-cutting issues in health care, such as antimicrobials, distribution, and waste, and frequently counsels clients on ESG and climate strategies and product development and marketing, including environmental attributes and claims.

Pharmaceutical, Medical Device, Pesticide/Antimicrobial, and Consumer Product Manufacturing, Labeling, Distribution, and Disposal

  • Advising health care facilities and medical waste service providers on medical/infectious waste, controlled substance disposal, and hazardous waste pharmaceutical management.
  • Counseling pharmaceutical manufacturers, logistics providers, and forward and reverse distributors on pharmaceutical waste characterization, management, transportation, and disposal; the EPA’s Management Standards for Hazardous Waste Pharmaceuticals; DEA Disposal Act compliance; and federal and state licensure matters.
  • Advised a pharmaceutical manufacturer on environmental compliance and enforcement matters pertaining to water and waste from its operations.
  • Providing EPA and FDA strategic counsel as companies develop and market antimicrobial consumer products, coatings, treated textiles, medical devices, pesticide devices, air filters and purifiers, disinfectants, and sanitizers.
  • Counseling consumer products companies on the development of Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) exempt treated articles and antimicrobial, biopesticide, conventional, and minimum risk pesticides.
  • Providing strategic advice on cosmetic and consumer product development, marketing, and acquisitions, including compliance with the FTC Green Guides, Federal Food, Drug, and Cosmetic Act (FFDCA), Fair Packaging and Labeling Act (FPLA), and Proposition 65.
  • Providing strategic advice to drug manufacturers on compliance with pharmaceutical take-back ordinances.
  • Representing a global supermarket chain with 11,200 stores across 32 countries with over 310,000 employees on environmental compliance matters pertaining to its supermarket stores and distribution facilities across the United States.
  • Counseling a floor manufacturer in product environmental compliance matters.

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