Laboratory refrigerated and ultralow temperature storage manufacturers could be in a tight spot thanks to a proposed U.S. Environmental Protection Agency (EPA) rule banning certain refrigerants and foam blowing agents from being used in laboratory equipment in order to limit substances said to cause global warming. The rule, part of the Clean Air Act’s Significant New Alternatives Policy (SNAP) program, would impact cold storage in a variety of other industries including the grocery, home fridge and freezer, and vending machine industries.
The proposed rule would only affect newly-manufactured products imported or exported after the implementation date, however, so lab managers would not have to replace the older refrigerated equipment in their labs.
“We’re just concerned that if you have delays and confusion on the import and export guidelines relating to two different deadlines, it’s going to impact crucial scientific and medical research and nobody wants to see that happen.”
While refrigerated lab product manufacturers support being more environmentally friendly, they need more time to meet the new regulations, according to Clark Mulligan, president of the Laboratory Products Association (LPA). The current deadline, which would be either January 1, 2016 for refrigerants or 2017 for blowing agents, isn’t an ideal timeframe for the lab industry to find viable replacements for the insulation and hydrofluorocarbon (HFC) refrigerants that will be banned, Mulligan explained.
“We would like to see the deadline pushed back,” Mulligan said. “For example, a lot of the equipment that our members make are considered medical devices and they’re approved by the FDA (U.S. Food and Drug Administration). If you have to go through and reengineer or redesign these products to accommodate new foam blowing agents and new coolants, you have to go through a re-approval process with the FDA.”
He adds that such a process can take quite a bit of time. Manufacturers would face a similar situation with the Department of Energy (DOE) and the ENERGY STAR Compliance Program. Because they would be reengineering their products, they would have to go through the process to get ENERGY STAR compliance all over again.
Over the pond
Adding to the challenges with meeting the deadline is the fact that similar regulations won’t come into effect in Europe until January 1, 2023, setting up a potential headache with imports and exports. Ideally, the lab industry would like the EPA deadline to be moved to 2023 to sync up with the European one in order to prevent confusion and compliance issues, Mulligan said.
“These products are crucial to research and medical care,” he said. “We’re just concerned that if you have delays and confusion on the import and export guidelines relating to two different deadlines, it’s going to impact crucial scientific and medical research and nobody wants to see that happen.”
In a Dec. 15 letter to EPA administrator Gina McCarthy, 33 members of Congress urged McCarthy to extend the deadline, highlighting concerns over cost, energy efficiency, and the impact on many different industries.
“It's [SNAP proposal] a good thing for the refrigerants but I'm not so sure about the insulation–non-refrigerant blown foams don't perform as well."
“We are concerned that the EPA’s proposal would require a full supply chain engineering and manufacturing transition with an infeasible timeline and does not adequately allow for the development of alternative chemicals,” the letter states. “Additionally, we recommend that the EPA coordinate with existing and expected Department of Energy (DOE) efficiency standards.”
Mulligan added that while other industries will have some challenges in meeting the new rules, the key is to differentiate the lab cold storage industry from the consumer cold storage industry, which doesn’t need to meet the strict requirements that lab products do.
“We’re different because our products are very complicated and complex and they’re capital expenses for most labs; [laboratories are] going to pay tens of thousands of dollars for these things and they want to make sure that over time, they’re going to work,” he said. “If they’re being reengineered and redesigned, [end users] want to make sure they’re going to work for a long time in the lab.”
The manufacturer's view
Currently, laboratory cold storage manufacturers are busily working as they try to meet the earliest proposed deadline.
Jean Fallacara, CEO of Montreal-based biomedical equipment manufacturer Z-SC1, says his company has already been using natural refrigerants for decades, so there shouldn’t be any impact on the company’s product or service procedures there, but the new foam blowing agents could pose a challenge.
“It's [SNAP proposal] a good thing for the refrigerants but I'm not so sure about the insulation–non-refrigerant blown foams don't perform as well,” he said.
Chris Champlin, vice president and general manager of controlled temperature technologies at Thermo Fisher Scientific supports the environmental aims of the new rules, while also highlighting the need for more time to accommodate them.
“Thermo Fisher Scientific supports the ultimate goal of the proposed regulations and our strategy has already been toward an environmentally responsible product roadmap,” Champlin said. “We support phasing out these refrigerants and blowing agents, and we have requested additional time to do so.”
There is still a good chance that manufacturers will get their wish and the EPA will extend the deadline. At an EPA meeting he attended in the first week of March, Mulligan said the government body indicated that they were looking to give a final ruling on the SNAP deadline by early summer.
“My own personal feeling is they’ve heard from us, and I think they will probably give the lab products industry a little more time, until 2023, but I don’t know,” Mulligan said. “2023 would coincide with the European Union so it makes a lot of sense. We’ll have to wait and see what happens.”