The decision for a company to seek approval from the U.S. Environmental Protection Agency (EPA) on a product can be beneficial in the long run, but the road to get there may be a long one.
In August 1998, Industrial Test Systems (ITS) began its journey on the path to EPA approval for its Sensafe Free Chlorine Water Check test strips. After many outside studies, research, testing and reporting, the EPA approval for ITS’s Sensafe test strips came through this past March.
The Sensafe Free Chlorine Water Check test strips contain ITS’s patented aperture feature, which enables the strip to be nearly 10 times more sensitive than a typical test strip. Because of this sensitivity, the strip is able to measure and detect free chlorine at EPA limits (the minimum EPA limit is 0.2 ppm and the maximum is 4 ppm). ITS decided to pursue the EPA approval so that water treatment facilities would be able to use their product.
“If it is approved by the EPA, it can be used for reporting purposes,” said Howard Ray, manager of research and development for ITS. “So folks who have to comply with the Clean Water Act can now use our product.”
Ray was responsible for the approval process and worked closely with the EPA to ensure the steps were taken to successfully navigate through the process. He began by writing to the EPA stating ITS’s intent and inquiring how to go about the approval process. Ray then reviewed the EPA’s guidance document to understand the requirements step by step. From this point, Ray now had someone with the EPA to contact with questions and concerns.
Step by Step
The first step in the approval process was to have a protocol for testing approved. A process to follow for this was already written, but according to Ray, the process was written for instruments. Because ITS was approving a test strip, the process did not quite fit. “We had to discuss that and come up with the best way to test [the strip], a way that [the EPA] would approve that we and the EPA thought was appropriate.”
After revising the testing protocol, a series of outside studies had to be performed by independent laboratories. ITS was required by the EPA to have three outside studies performed, which they had completed in 2000. However, after the EPA reviewed the data, it decided an additional study would have to be done. This was completed in 2003.
In October 2003, ITS received the letter of intent stating ITS’s product would be proposed in the next rule making. The waiting game followed, and in March 2007, the final rule including the Sensafe free chlorine test strip was printed in the Federal Register.
“The longest part was the wait between the letter we received that said we would be proposed in the rule making to the time it finally made it to the Federal Register—that was almost four years,” Ray said. “Several things happened though. September 11th
changed a lot of the focus for the EPA, and then there were administrative changes. All that played a part in our status and how long we had to wait.”
Throughout the process, Ray was closely involved with developing the validation process that the EPA used to approve the product. “I was responsible for making the contact, making sure studies were performed and writing any reports,” said Ray. “Once studies were performed, a report was sent to the EPA for their evaluation.”
Now that ITS’s Free Chlorine Testing Strip is EPA-approved, it holds more credibility. “It means that the EPA has looked at this very intensely and has evaluated the performance data generated by novice users,” Ray said. “It shows they felt comfortable enough with the data that we sent that the test could be used for accurate reporting.”
The EPA approval process may be a long one to get through, but in the end it can be very beneficial for both the product and water treatment professionals everywhere.