Consumers have become increasingly aware of the risks associated with drinking contaminated water and the need to consume water that is free of chemicals, bacteria, and other contaminants. Consequently, the demand for water testing services has been on the rise. In addition, rising cases of water-borne disease outbreaks such as dysentery, cholera, and typhoid have also contributed to the growth of the water testing industry, which has been predicted to maintain a CAGR of 7.3% in the period from 2017 to 2027. This presents a potentially lucrative opportunity for laboratories that offer water testing; however, measures have to be put in place to ensure that the highest possible quality standards are maintained during water testing. To this end, it is incumbent for water testing laboratories to adhere to compliance and standards set by both federal and state agencies that are tasked with the responsibility of ensuring water safety.
Who Sets Standards for Water Testing?
At the federal level, water safety standards are set by the Environmental Protection Agency (EPA) which is an independent agency of the US federal government. The EPA also regulates water testing at the state level although individual states may set additional standards and measures to support water safety. NELAC is an agency of the EPA that specifically regulates laboratory accreditation for environmental testing, but participation is voluntary. Water testing laboratories are also expected to adhere to ISO standards that apply to water testing, such as ISO 17025. Below is a breakdown of all the regulatory and compliance standards that water testing laboratories need to adhere to.
Safe Drinking Water Act (SWDA) Analytical Methods and Laboratory Certification
The Safe Water Drinking Act (SWDA) is a US federal law that sets standards for safe drinking water. SDWA requires that the EPA implements a certification program for laboratories that test drinking water. Such laboratories also need to use testing methods that have been approved by the EPA. Apart from certification, the EPA also offers various training for water testing laboratories such as radiochemistry testing.
21 CFR Part 11
This standard applies to all laboratories that handle electronic documentation and signatures. Water testing laboratories that use LIMS to manage samples and data must comply with the requirements defined in this standard.
There are various ISO standards that apply to water testing. ISO 17381:2003 provides guidance on the selection of ready-to-use methods in water analysis. Such methods, unlike standard methods, are swift and inexpensive. ISO 5667 provides guidance on water quality sampling and analysis. On the other hand, ISO 17025 provides general guidelines for ensuring quality standards in analytical laboratories. At the end of the day, ISO compliance is not mandatory but is beneficial to the laboratory and its various stakeholders.
Information Collection Requirements (ICR) for Drinking Water Laboratories
The ICR applies to surface water bodies that serve more than 100,000 people and groundwater bodies that serve more than 50,000 people. This rule was created by the EPA in an effort to collect and analyze data on the risks versus benefits of disinfecting drinking water. ICR sets laboratory approval requirements for compliant testing.
UCMR Laboratory Approval Program
The fifth Unregulated Contaminant Monitoring Rule (UCMR 5) was set by the EPA to monitor the collection and testing of water samples for 30 chemical contaminants using methods developed by the EPA and other consensus organizations. The EPA has created a manual with approval requirements and standards for laboratories that will take part in UCMR 5.
The National Environmental Laboratory Accreditation Program (NELAP) was created by TNI (The NELAC Institute) to provide consistent standards for environmental testing laboratories, similar to the standards offered by the ISO. These standards are created through consensus and are voluntary. They are intended to improve laboratory services by providing high-quality data on water testing.
Water testing laboratories perform a pivotal role in ensuring safe access to drinking water. These laboratories usually conduct three types of tests: physical, chemical, and biological, and in the process, they handle tons of samples requiring different kinds of tests on a regular basis. These samples have metadata that identifies them and describes their characteristics.
While manual data management methods can work for smaller laboratories, they are likely to result in errors and inefficiencies when applied to laboratories that handle high volumes of samples. Therefore, it is advisable for laboratories to transition to the best water LIMS solution once their volumes begin to pile up.
How Does Water LIMS Support Compliance & Standards in Testing Laboratories?
As demonstrated above, water testing laboratories are constantly under pressure to keep up with the numerous regulatory requirements. A breach of these standards is likely to have reputational and financial implications.