LIMS for Environmental Labs: Driving Compliance With Testing Regulations and Standards

The demand for environmental testing has increased as people have become more aware of the benefits of a clean and safe environment vis-a-vis the risks of a contaminated one. The value of the global environmental testing market is gunning for the $20 billion mark by 2030.  Regulatory compliance demands placed upon environmental testing laboratories have been growing in tandem to ensure that quality and safety standards are maintained across the board. 

Environmental testing laboratories across the world are subject to several regulations and standards that may apply to laboratory testing in general or to the different types of environmental tests that a laboratory conducts regularly. All environmental laboratories in the US are subject to the Environmental Protection Agency (EPA) regulations that are codified under Title 40 of the Code of Federal Regulations (40 CFR). 

The EPA was established in 1970 under President Richard Nixon as an independent agency to oversee environmental protection matters. The EPA provides a framework and guidelines to ensure that federal requirements are upheld and any violations are addressed appropriately. The EPA has provided guidance documents to direct the implementation of regulatory requirements. 

Apart from the CFR, environmental testing laboratories are governed by other regulations and standards as well. In this blog, we review the important regulations and standards that you should be familiar with in case you want to venture into environmental testing. 

40 CFR 

This regulation sets good laboratory practice standards for environmental testing laboratories. It provides general provisions on how environmental laboratories should carry out their operations. It also outlines standards for personnel, equipment, and other specific areas such as pesticide management. This regulation has various parts. For example, part 160 sets standards for pesticide management, part 112 outlines requirements for creating and executing a plan for preventing, controlling, and countering oil spills, part 60 covers New Source Performance Standards for air pollution control, while part 792 sets standards for the health and environmental effects of chemical fate testing. You can get more information on 40 CFR here.

NELAC (TNI)

The National Environmental Laboratory Accreditation Program (NELAC) is a voluntary program that sets national standards for the accreditation of environmental laboratories. The Nelac Institute (TNI) sets standards that are a compilation of ISO standards that apply to environmental laboratories. 

ISO 17025

The International Organization for Standardization (ISO) is an international standard that is set by member countries and outlined in Article 3 of the ISO Statutes. ISO 17025 is applicable to any laboratory that carries out testing, sampling, or calibration and seeks to produce reliable results. 

CERCLA

The Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) provides a Federal “Superfund” to remediate unmanaged or deserted sites containing hazardous waste, as well as any instances of spills, accidents, or unplanned releases of pollutants or contaminants that pose a threat to the environment.  While environmental laboratories may not be directly affected by CERCLA compliance, it is important to understand how their clients may be affected by CERCLA.

GLP

Good Laboratory Practice (GLP) is a set of guidelines and regulations that ensure the quality, reliability, and integrity of non-clinical safety studies of chemicals, including those performed for environmental testing. Compliance with GLP standards is crucial for environmental testing laboratories, as it promotes accuracy, consistency, and transparency in laboratory procedures, data recording, and reporting. Adhering to GLP standards not only helps to ensure regulatory compliance but also improves the credibility and validity of the laboratory’s test results. It ultimately leads to better decision-making and actions concerning environmental protection and public health.

GALP

The environmental data used by the EPA is analyzed and reported by environmental testing laboratories. Most of these laboratories rely on Laboratory Information Management Systems (LIMS) to acquire, store, analyze, and archive the data.  However, the EPA lacks a consistent set of standards for good LIMS practices and that’s where Good Automated Laboratory Practices (GALPs) come in. The ALPs provide a consistent and standardized set of guidelines to guarantee the accuracy, reliability, and credibility of all LIMS data utilized by the EPA. 

The Unregulated Contaminant Monitoring Rule (UCMR)

The EPA uses the UCMR to collect data on suspected contaminants in drinking water that lack health-based standards for evaluation under the Safe Drinking Water Act (SDWA). It is important to note that the EPA bears the cost for the testing of samples from systems that serve 10,000 or fewer people. The EPA also coordinates the approval process for laboratories wishing to take part in testing UCMR samples.

Clean Water Act (CWA)

CWA publishes a list of approved analytical methods, also referred to as the “304(h)” or “Part 136” methods to test chemical and biological contaminants in wastewater, ambient water, and sewage sludge. Environmental laboratories use various CWA methods to test for these pollutants.

National Pollutant Discharge Elimination System (NPDES)

The NPDES protects water resources by limiting the discharge of pollutants and effluents into water sources. This program plays a critical role in environmental testing laboratories by establishing permit requirements and effluent limitations for facilities that discharge pollutants into surface waters. Compliance with NPDES permit requirements is crucial for environmental testing laboratories, as it ensures that their activities do not contribute to water pollution and damage to aquatic ecosystems. Adhering to NPDES regulations helps laboratories to reduce their environmental footprint, minimize liability risks, and maintain their reputation as responsible environmental stewards.

RCRA

The Resource Conservation and Recovery Act (RCRA) is a US federal law that regulates the proper management and disposal of solid and hazardous waste. This Act allows the EPA to set rules on how those wastes are handled from when they are created until they are finally disposed of in incinerators, landfills, and Underground Storage Tanks (USTs). 

OSHA

The Occupational Safety and Health Administration (OSHA) provides standards and rules to protect laboratory staff from different kinds of injuries at the workplace. OSHA’s laboratory standard (29 CFR 1910.1450) mandates all laboratories to have a designated Chemical Hygiene Officer and also to have a written Chemical Hygiene Plan (CHP) in place at all times.

How Does a LIMS for Environmental Labs Support Compliance with Testing Regulations & Standards?

Environmental testing laboratories can easily get overwhelmed by the numerous regulatory requirements and standards that they have to keep up with. While an environmental laboratory may opt to manage this manually, this route is prone to errors and any breaches usually come at a hefty cost; financial and loss of reputation. 

A LIMS for environmental labs automates processes and hence maximizes operational efficiency. A LIMS for environmental labs improves data quality and manages several functions simultaneously to ensure smooth workflows that are error-free and improves data quality. Furthermore, a cloud-hosted LIMS for environmental labs helps meet specific operational, security, and regulatory needs. 

CloudLIMS has been uniquely designed to support compliance with various regulatory standards, such as CFR 40, ISO 17025, NELAC (TNI), and GLP, that are fundamental to environmental testing. This LIMS is easy to deploy and configure to suit the needs of environmental testing laboratories. The LIMS for environmental labs comes with enhanced flexibility to help laboratories to adjust to any fluctuations in the regulatory environment. CloudLIMS offers the ultimate solution to help laboratories thrive in varied regulatory environments.