Laboratory Legal Requirements

Also, be sure to set additional emergency reporting requirements for your state and region. It is important to recognize that the characteristics of wastewater treatment plants vary from place to place. These factors and local regulations govern the types and concentrations of chemicals that can be removed. While CJRA regulations exempt mixtures of hazardous waste and domestic wastewater from the Hazardous Waste Regulations, local regulations for sewage disposal are often more restrictive. While the disposal of some non-hazardous chemicals may be acceptable, the disposal of hazardous chemicals is only permitted under carefully prescribed circumstances. Some institutions, responding to strict local controls and concerns, simply adopted a conservative attitude for political reasons and banned the disposal of laboratory chemicals. Nurses and maintenance personnel who supervise the laboratory remain subject to the hazard communication standard and other OSHA standards, which specify the information, training, and health and safety precautions required for non-laboratory personnel. Those who run and work in laboratories should also recognize that violations of environmental health and safety laws and regulations can not only pose unnecessary risks to laboratory personnel and the surrounding community, but can also result in serious collateral consequences – imposition of civil penalties (fines of up to $25,000 per day per violation), as well as there is an exception to the PMN requirement for chemicals, used for research and development. or in a use regulated by another jurisdiction (e.g., exclusively for FDA-regulated medical purposes), but the EPA still considers the use of research and development to be a commercial activity. This exemption includes significant notification and personnel record requirements (R&D exception: 40 CFR 720.3, 720.36 and 720.78). OSHA`s Hazardous Waste Operations and Emergency Response standard (29 CFR § 1910.120) establishes criteria for training, worker protection, and disposal of spills and releases to the environment. This standard is an excellent reference for planning your response to spills and releases in the laboratory. This standard must be met by contractors and fire departments when responding to laboratory emergencies involving hazardous substances.

Commerce`s Export Administration Regulations (EAOI) require permits to export a variety of research material. These materials (including chemicals and laboratory equipment) are classified and assigned an export control classification number. (Look the ECCN list for examples of regulated exports.) Just a few years ago, it was common to dispose of a lot of laboratory waste down the drain. Today, the indiscriminate disposal of laboratory chemicals in the sewer system is unacceptable. Most laboratory drainage systems are connected to sanitary sewage systems, and their wastewater is eventually discharged into a wastewater treatment plant. Some chemicals can interfere with the proper functioning of wastewater treatment plants or affect particularly sensitive waters into which the chemical is discharged. In the drainage system of the laboratory itself, certain chemicals can cause fire, explosion or local risks of air pollution. Others can corrode the drainage system. The following is a summary of TSCA`s rules regarding R&D exemption requirements: (2) The accreditation program or state licensing program shall meet the requirements of this subsection and shall be approved by CMS. In addition, OSHA standards address some important laboratory design and design issues, such as eyewash stations, safety showers, and special ventilation requirements. Other consensus standards created by organizations such as ANSI and the American Society of Heating, Refrigeration, and Air Conditioning Engineers are relevant to laboratory design. It is not uncommon for various codes and consensus standards to be incorporated into state or federal regulations.

The section of the federal regulation titled “Standards and Certification: Laboratory Requirements” is published by the Centers for Medicare & Medicaid Services (CMS) to enact the CLIA Act passed by Congress (see below). In general, CLIA regulations set quality standards for laboratory tests performed on human samples such as blood, body fluids and tissues for the purpose of diagnosing, preventing or treating diseases, or assessing health. The final CLIA rules were published in 1992, phased in until 1994 and amended in 1993, 1995 and 2003. Visit the CLIA documents page to search and view Federal Register notices and previous editions of the Code of Federal Regulations (published each October). CMS Investigation Procedures and Interpretation Guidelines for Laboratories and Laboratory Services (Appendix C)external symbol Interpretive guidelines for CLIA regulations are published in the CMS Government Operations Manual (SOM). The SOM is used by government agencies to administer various federal programs, such as clinical laboratory certification under CLIA regulations, and is enforced by CMS. It is also a source of guidance for laboratories in interpreting CLIA regulations. Under Title III of SARA, the Superfund Amendments and Reauthorization Act, facilities that use hazardous chemicals in their operations must maintain safety data sheets (MSDSs) required by the OSHA hazard communication standard, submit copies of safety data sheets, and submit copies of safety data sheets, and Provide inventories of hazardous chemicals and report accidental releases to emergency planning authorities.