Government regulations are constantly a challenge for ink manufacturers and their suppliers, and when there is a change on governments, those changes can be even more abrupt. Even laws that were agreed to by all parties have unintended consequences.

Such is the case in the US with the Toxic Substances Control Act, or, as it is better known, TSCA. According to the US Environmental Protection Agency (EPA), “The Toxic Substances Control Act of 1976 provides EPA with authority to require reporting, record-keeping and testing requirements, and restrictions relating to chemical substances and/or mixtures.”

There were flaws to TSCA, and the law was amended in 2016 with The Frank R. Lautenberg Chemical Safety for the 21st Century Act. While this law was expected to improve chemical reporting, plenty of challenges have appeared, including new risk evaluation/assessment requirements for premanufacture notification (PMN) or Significant New Use Rules (SNUR).

David Wawer, executive director of the Color Pigments Manufacturers Association, Inc. (CPMA), said that there is an interesting dynamic going on within US EPA as a result of election of Joe Biden as president.

“The new wave of political appointees to USEPA have displayed a pro-NGO (non-governmental organization), pro-increased regulations on industry mindset, at least in the first year,” Wawer noted. “The individual appointed to head the Office of Pollution Prevention & Toxics (OPPT) decided, after a couple of months in the position, to reopen seven of the first 10 completed chemical risk evaluations, and to direct agency staff to incorporate environmental justice components into these risk evaluations.

“Agency staff has been pulled from current risk evaluation activities (next 20 chemical substances), and reassigned back to the seven completed risk evaluations that were reopened,” added Wawer.

Wawer pointed out that the EPA has continued its regulatory practice, however, established after the Lautenberg Act was passed in 2016, of treating all new chemicals as SNURs, and insisting that PMN applicants conduct very expensive data studies as part of the PMN process.

“In effect, every new chemical substance approved by EPA since 2017 has a SNUR. And the PMN process now extends for years, instead of months,” added Wawer.

George Fuchs, director, regulatory affairs and technology for the National Association of Printing Ink Manufacturers (NAPIM), noted concerns with the interpretation of the law.

“EPA, under the new Toxic Substances Control Act, is continuing to develop its interpretation of ‘unreasonable risk’ standard (for use in both PMN and SNUR) which is not defined in the regulation,” Fuchs said. “The potential for a lengthy and expensive approval process has the potential to inhibit the development of new materials. There is also concern that the EPA risk assessments are overstepping the boundary between EPA and OSHA.”

Rebecca Lipscomb, director global regulatory affairs for INX International Ink Company, said that INX is actively engaged in enhancing its risk protocols.

“We are actively engaged in enhancing our risk protocols specific to SNURs as we expect the use of SNUR as a policy to have a large impact on the use of future chemicals,” said Lipscomb. “We have dedicated a large amount of resources in this area to roadmap successful use of materials, while ensuring the supply chain understands their responsibilities to ensure the safe use of materials.”