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    STP1216

    Quality Assurance in Programs Regulated by the U.S. Environmental Protection Agency

    Published: 0


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    Abstract

    Industry and government are making efforts to standardize requirements to ensure data integrity and quality. Currently, programs regulated by different divisions of the U.S. Environmental Protection Agency (EPA) include different administrative and technical requirements for similar types of studies. Programs include the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) and the Toxic substance Control Act (TSCA), regulated by Good Laboratory Practices (GLP), and “non-GLP” environmental monitoring programs such as the National Pollutant Discharge Elimination System (NPDES), Resource Conservation and Recovery Act (RCRA), and Comprehensive Environmental Response Compensation and Liability Act (CERCLA) commonly known as Superfund. GLPs regulate most data submitted to EPA in support of product registration. GLPs include specific requirements for ongoing internal evaluations, an independent Quality Assurance (QA) program, data collection, and archival of data. These requirements are not mandated to the same degree under environmental monitoring programs of NPDES, RCRA, and CERCLA. Environmental monitoring programs rely on laboratory accreditation, outside proficiency testing, and quality control, which are not traditionally part of the GLP program. Thus, the quality of environmental monitoring programs rely on periodic external evaluation of performance rather than an ongoing internal evaluation of laboratory activities implemented in the 6LP program. Attempts to universalize requirements to ensure data integrity and quality science are discussed, along with pros and cons to each approach.

    Keywords:

    Quality Assurance, Good Laboratory Practices, Environmental Monitoring Programs, Environmental Protection Agency


    Author Information:

    Royal, PD
    Director of Regulatory Affairs and Quality Assurance, Springborn Laboratories, Inc., Wareham, MA

    Jop, KM
    Program Manager of Effluent and Solid Waste, Springborn Laboratories, Inc., Wareham, MA


    Committee/Subcommittee: E47.13

    DOI: 10.1520/STP13143S