Federal Regulations and Guidelines | University of Maryland Eastern Shore Marketing Retarget Pixel

Federal Regulations and Guidelines

  • NIH Guidelines for Research Involving Recombinant DNA Molecules

    • Recombinant DNA work conducted at the University must comply with these guidelines. Compliance includes the registration and approval of work covered by the guidelines with the University Institutional Biosafety Committee.

    Biosafety in Microbiological and Biomedical Laboratories

    • These guidelines are published by the Centers for Disease Control and Prevention (CDC) and the National Institutes of Health.
    • This document provides guidance on facility design, microbiological practices, and equipment for one of four levels of containment (BSL-1-4).
    • Agent summaries are useful in conducting risk assessments and determining the level of containment required

    OSHA Bloodborne Pathogens Standard

    • Work with human material is regulated by the Occupational Safety and Health Administration (OSHA) Bloodborne Pathogen Standard and applies to all occupational exposure to blood or other potentially infectious material. Any research laboratories working with human materials and clinical areas must comply with this standard.  Please refer to the Bloodborne Pathogens Exposure Control Plan for detailed information on handling human material.

    CDC Select Agents Program

    USDA/APHIS Select Agents Program

    • Select Agents are microorganisms and toxins that have potential for use by terrorists.  The Public Health and Security and Bioterrorism Preparedness and Response Act of 2002 restricts their possession and use, and requires the University to collect and maintain information of the location and use on campus of any select agents or toxins.  Failure to provide notice may result in civil and criminal liability for individual researchers and/or the University.
    • These federal regulations must be complied with in order to possess, use or transfer select agents.

    CDC Permit to Import or Transport Etiologic Agents 

    • The importation of etiologic agents is governed by federal regulation: USPHS 42 CFR - Part 71 Foreign Quarantine Part 71.54 Etiologic agents, hosts, and vectors
    • CDC import permits are required for the importation of etiological agents, receipt of select agents from BEI/ATCC, and for the receipt of Highly Pathogenic Avian Influenza (HPAI) from any source.

    USDA/APHIS Permit to Import or Transport Livestock Pathogens 

    • USDA's Animal and Plant Health Inspection Service (APHIS) is responsible for enforcing regulations governing the import and export of plants and animals and certain agricultural products. 

    USDA/APHIS Permit to Field Test, Import, or Transport Genetically Modified Organisms 

    University of Maryland Form for Registration of Biological Materials 

    Selection, Installation, and Use of Biological Safety Cabinets