Toxicology Quality Assurance
Aquatic and terrestrial toxicity tests are used to determine whether soil, sediment, or water have been impacted by contaminants, to evaluate effects of new and existing chemicals, and to assess whether wastewater and effluents can be safely released to the environment. The liability associated with inadequate toxicological characterization, by either over- or under-estimating actual toxicity, can be enormous. Therefore, the quality of testing is of great importance. While rigorous quality assurance evaluations, such as data validation, are routine for chemical characterization of samples, analogous toxicity testing quality assurance measures are limited.
Toxicity testing laboratories can employ quality management systems to help meet test acceptability requirements and ensure quality results. Critical components of quality management systems for testing programs include:
- emphasis on analyst training, particularly with regard to culture and maintenance of test organisms
- maintenance of standardized operating procedures
- maintenance of method-required environmental conditions
- use of standard reference toxicants
- testing multiple control or reference samples with each batch of toxicity tests
- keeping detailed records
- performing appropriate statistical analyses
- routine laboratory audits
Environmental Standards provides a corporate liability overview by documenting the defensibility of the quality assurance and quality control in your in-house or contracted toxicity testing laboratories. We shield our clients from undue exposure to liability from the use of poor quality data.
Technical Testing Specifications
Our Quality Assurance professionals can prepare comprehensive technical specifications covering QA/QC measures to be followed by contracted toxicity testing laboratories. We employ our expertise in specifying metrics that must be achieved when testing client samples using EPA, ASTM or other published toxicity test methods. We have the expertise to ensure that situation-specific (e.g., stemming from an emergency response situation) or institution-specific protocols are being followed to ensure generation of high-quality results.
Toxicity Testing Laboratory Audits
Environmental Standards audits toxicity testing laboratories worldwide on behalf of industrial clients, potentially responsible party committees, and engineering and environmental law firms. These rigorous audits exceed International Standards Organization (ISO) and National Environmental Laboratory Accreditation Conference (NELAC) audit requirements. Environmental Standards’ Toxicology QA staff will visit your contracted bioassay laboratory and review its internal programs, processes, and information provided (e.g., testing protocols). On-site audits such as this are indispensable for assessing liabilities that may arise from using in-house or contracted toxicity testing laboratories.
A comprehensive Quality Assurance Project Plan (QAPjP) leads to consistent quality and reliable toxicological data. Environmental Standards has prepared project-specific QAPjPs by carefully documenting the sampling and analysis quality assurance and quality control procedures necessary to achieve project data quality objectives. We avoid the pitfalls – such as delays, excessive costs, and jeopardizing an industry’s relationship with regulators – of submitting a deficient QAPjP for agency review.
Toxicity Data Validation
Our Quality Assurance professionals perform rigorous data validation of toxicity dossiers that are ideally prepared following our technical specifications or alternatively by following third-party procedures. We ensure that the results are sound and based on properly followed protocols to minimize the environmental liability of releasing toxic material to the environment or, conversely, allocating unnecessary resources to manage toxicity where none exists.
Litigation Support Services
Environmental Standards has the technical breadth, expertise, and necessary credentials to provide solid legal support in all matters of client litigation. We support Fortune chemical, petrochemical and coal-fired utility industries and we prepare our clients for litigation by ensuring defensibility of data. We provide expert witness and deposition to facilitate favorable and timely adjudication.