NWRC Research Areas: Regulatory Support Services Unit

Last Modified: July 11, 2024
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The Regulatory Support Services Unit (RSSU) serves personnel at the NWRC, within Wildlife Services (WS), and broadly within APHIS. There are five distinct regulatory compliance and facilitation components within the RSSU – technology transfer, product registration, NWRC environmental compliance, NWRC safety, and NWRC Quality Assurance.

Technology Transfer Activities

  • Manages WS Inventions/Patents, Licenses, Agreements with Intellectual Property components and Product Development.
  • Supports technology transfer activities as listed above for the broader APHIS community, in partnership with the Technology Transfer Coordinator, Forest Service – Research & Development.
  • Maintains APHIS technologies’ non-confidential summaries and commercialization partnerships.

Product Registration Activities

  • Manages, provides guidance, and assists with the development, use, and maintenance of regulated products (including pesticides, animal drugs, veterinary biologics, and pest control devices) used for wildlife damage management.
  • Develops and provides data and information to regulatory agencies to register and maintain existing registrations of APHIS pesticides and authorizations for certain veterinary biologics and animal drugs used by WS and cooperators.

NWRC Environmental Compliance Activities

  • Provides support and technical writing for National Environmental Policy Act (NEPA) and Endangered Species Act (ESA) requirements to NWRC research and other activities.

NWRC Safety Activities

  • The Regulatory Compliance Specialist functions as the NWRC Collateral Duty Safety and Health Officer (CDSHO) and NWRC Chemical Hygiene Officer (CHO), working with the Biosafety Officer and the NWRC Safety Working Group to ensure compliance with relevant guidelines, directives, and laws.
  • The Biosafety Officer also serves as the Chair of the NWRC Institutional Animal Care and Use Committee (IACUC) and the Institutional Biosafety Committee (IBC), working closely with the NWRC Animal Care Unit to ensure compliance with the Animal Welfare Act.

NWRC Quality Assurance Activities

  • Ensures all planned research follows EPA, Food and Drug Administration, USDA, APHIS, Wildlife Services, and NWRC laws, regulations, policies, and guidelines.
  • Manages the protocol process, maintains Standard Operating Procedures, and performs Good Laboratory Practice (GLP) inspections for regulated studies.

Sarah Hibbs-Shipp, PhD, National Wildlife Research Center Regulatory Support Services

Unit Leader & Technology Transfer Manager

NATIONAL WILDLIFE RESEARCH CENTER

4101 LaPorte Avenue

Fort Collins, CO 80521

TEAM MEMBERS

Emily Ruell, MS, MA: Registration Manager

Lucas Oligschlaeger, MS: Regulatory Compliance Specialist – CDSHO, CHO, NEPA/ESA

James Carlson, MS: Biosafety Officer, IACUC Chair, IBC Chair

TBD: Quality Assurance (Research) Specialist