Chemicals to fall under more regulatory scrutiny

CUYAHOGA FALLS, Ohio—Scott Boito is used to being the bearer of bad news. It comes with being a product steward for chemical intermediates at Eastman Chemical.

And giving the regulatory update during the recent Hose & Belt Manufacturers Conference in Cuyahoga Falls didn't change that. Changes, he warned, are underway or on the horizon in both the U.S. and Europe.

In the U.S., the EPA is conducting 22 high-priority risk evaluations. It's a three-year process, and the agency is a little more than halfway through. The investigations will include seven phthalates, including DEHP, which he said likely will have the most impact on hose and belt makers. Other chemicals being evaluated include several chlorinated substances, three flame retardants and formaldehyde.

"We will start to see some restrictions on manufacturing that (do not) currently exist for many of these substances," Boito said. "We will see some restrictions on shipping for these products, and probably start to see some restrictions on end uses."

The EPA also has proposed completely reformatting its method of hazard and risk assessments on new and existing chemicals. Boito said evaluations of new materials are seeing severe delays. Instead of 90-day reviews, the process is taking longer than two years for each evaluation.

The Eastman Chemical official said he expects to see few new "general purpose" Toxic Substance Control Act listings for chemicals, with the EPA instead looking to test for specific applications. This means most new chemicals will come with a significant new use rule.

And for existing chemicals, the U.S. EPA's risk evaluations are undergoing what he calls a "sea change" in methodology. The EPA is taking a more hazard-based assessment, where the agency is looking at the materials in a "worst-case scenario," rather than taking into account all the safe uses that make up the vast majority of usage.

"They're now assuming that nobody wears PPE any of the time," Boito said. "It essentially turns everything into a hazard evaluation. Everything is going to change from risk evaluation to risk management."

Another area of concern is on PFAS, or per- and poly-fluoroalkyl substances, with focus coming from both the U.S. and Europe. First of all, regulatory agencies are using broad definitions aimed at being "all-inclusive of existing and possible future poly-fluorinated substances," he told conference attendees.

In the U.S., Boito said states and the EPA are passing laws and rules to limit or ban PFAS in all consumer uses.

"The federal EPA is trying to wrap their hands around what PFAS means and how they can start to regulate it," he said. "Once they do, they are going to move very quickly. They want to make sure the states don't get too far ahead. They're trying to play catch up a little bit, and when they do, they will overtake everyone who is thinking about it."

In Europe, outright bans already exist in some markets, and more likely will be forthcoming. "Things will change very quickly for PFAS. If you have any PFAS in your materials, it may be time to start looking at some alternatives and make sure you are aware of what is going on and what's going to happen in your supply chain when those things are no longer available, Boito said.

Europe also is moving quickly to ban phthalates for all applications within three years. First through REACH and now the Medical Device Regulation, the continent has taken aim against DEHP and other classified phthalates.

REACH, late last year, removed an exemption for using it in medical materials. This gave medical device makers three years to get the chemical out of its materials, impacting such items as tubing, saline bags and blood bags. U.S. medical device makers indicated that, given all the approvals needed, it would take up to 10 years for a formulation change, more than triple the deadline in Europe.

Saving the best for last, Boito said the European Chemicals Strategy for Sustainability (CSS) will go well beyond what REACH has done in its tenure. Within 20 years, he said substances with no current classification under REACH likely will have two to three classifications with regard to CSS. He estimates there will be five to 10 times more substances that will be classified under CSS guidelines.

"This is something that everyone will have to prepare for," Boito said. "These are not new substances. They are existing substances that will have to undergo new testing and have new classifications, which are designed to say 'We don't want you to have that stuff in your products anymore.'

"... CSS is evolving so quickly," Boito said. "Two years ago, it didn't exist. Now it's No. 1 on my hit list."