In 2016, the US implemented the Lautenberg Chemical Safety Act (LCSA or New TSCA), which was its attempt to simplify the existing regulatory approach. However, it may have had unintended consequences.
Industry regulatory leaders said that the ink industry and its supplies have been impacted by the implementation of LCSA, including slowing down the approval process as well as higher costs for approvals.
According to environmental lawyers Tom Berger and James Votaw at Keller and Heckman LLP, new and existing inks and ink products have been adversely impacted by the 2016 enactment of the Lautenberg Chemical Safety Act (LCSA), which amended the Toxic Substances Control Act (TSCA) (15 U.S.C. § 2601 et seq.).
According to Berger and Votaw, companies developing new inks for manufacture, import, and/or use in the US have had to navigate a more onerous and protracted TSCA Section 5 new chemical premanufacture notification (PMN) process. The amendments require the US Environmental Protection Agency (EPA) to affirmatively approve the manufacture of a new chemical considering all of the chemical’s known and reasonably foreseeable uses. This has slowed EPA’s approval of new chemicals, which now may take six to nine months or longer.
“The Lautenberg Act has certainly impacted the chemical industry and printing inks are subject to the law just as any other chemical company would be,” said Rebecca Lipscomb, director, global regulatory affairs for INX International Ink Co. “I would imagine the entire industry has had to make adjustments and put procedures in place to meet the implementation of the new TSCA.”
Pigment Violet 29
George Fuchs, director – regulatory affairs and technology for the National Association of Printing Ink Manufacturers (NAPIM), reported that the direct and indirect impacts of the LCSA continue to be felt through the graphic arts industry, such as the case of Pigment Violet 29.
“The direct impacts relate to EPA’s consideration/assessment of specific chemicals like Pigment Violet 29, which raises alarm throughout our supply chain,” Fuchs said. “The indirect impact relates to the reduction in research and development for new materials because of the significant costs associated with compliance with the LCSA.”
David Wawer, executive director, Color Pigments Manufacturers Association, Inc.(CPMA), reported that CPMA staff and technical consultants have been actively engaged with EPA in the chemicals risk evaluation of Pigment Violet 29 since December 2016. He noted that the Lautenberg Act impacts all 38,000 chemicals in commerce in the US, including color pigments.
“Any new chemical substance created for commercial uses must undergo scrutiny and evaluation by EPA under New Chemical Substances regulations,” Wawer continued. “These regulations existed pre-Lautenberg as well. The primary difference since 2016 has been the extended length of time for EPA to approve new chemical substances (also known as the Premanufacturing Notification Process, or PMN).
“We’ve witnessed this negative impact firsthand with a new color pigment, recently approved by EPA for commercial use earlier in 2020,” Wawer added. “It took the company well over three years to obtain approval for a new, more environmentally friendly color pigment, as well as significant investment in research and testing required by EPA staff. Pre-Lautenberg, this new color pigment would have been approved for commercial use in less than a year. The additional EPA review scrutiny and requirements for bringing new color pigments to market is having a significant adverse impact on R&D innovation and introducing new products into the market.”
Wawer noted that the draft risk evaluation document published by EPA in 2018 concluded no risk to human health or the environment. A more recently published draft risk evaluation (October 2020) included some conclusions in direct contradiction to the 2018 draft document.
Color pigments industry experts believe EPA staff has misapplied and incorrectly interpreted additional technical and scientific data provided to EPA during the past two years, and is developing additional technical and scientific materials for EPA staff to review.
In future years, color pigments will be risk-evaluated using the templates and processes developed by EPA staff for the first 10 chemicals risk evaluations, which include Pigment Violet 29. Three color pigments on the EPA High Priority substances list (2012, 2014) will be designated for risk evaluation in the next EPA cycle for chemical risk evaluations.
Future Challenges
Michael Gould, technical key account manager, energy curing USA for RAHN USA, reported that the energy curing industry has been impacted significantly since the implementation of the Lautenberg Chemical Safety Act (LCSA) in 2016.
“Under LCSA, for a new chemical substance to be approved for use without restriction, US EPA must make an affirmative determination regarding the risk(s) of that substance to human health and the environment. Currently, EPA must conclude that a substance is not likely to present an unreasonable risk for all intended and foreseeable uses. Prior to LCSA, EPA could conclude that a substance would not pose an unreasonable risk (under specified conditions of use),” Gould said.
Although the change is subtle from a semantics perspective, Gould said that it has resulted in a sharp increase in the number of new chemicals that are being regulated under TSCA.
“Prior to LCSA, the number of regulated chemical substances was ~20%; since the implementation of LCSA, >80% of new chemical substances are being regulated,” he added. “Given that many chemicals which make up the standard industry ‘toolbox’ is reactive in nature, (they have acrylate functionality or are photoactive), they often have moderate health or environmental hazards – e.g., skin/eye irritants/sensitizers and moderate ecotoxicity. These moderate hazards essentially force EPA to control risk through regulation, specifically significant new use rules (SNURs), which have the effect of making the new substances less commercially attractive due to the complexities of compliance throughout the product value chain.”
When new inks and ink products are approved for manufacture, Berger and Votaw said they may be made subject to manufacturing and use conditions such as TSCA significant new use rules (SNUR), which may mandate the use of supplied-air respirators, restrict processing and handling methods to those that do not generate vapors, mists, and aerosols, limit or outright prohibit surface water releases of the substance, and impose other types of restrictions.
EPA also may issue SNURs for existing chemicals and recently issued one for long-chain perfluoroalkyl carboxylate (LCPFAC) chemicals. Some ink products are produced from and contain these LCPFACs, which use now may be restricted or banned. 85 Fed. Reg. 45,109 (Jul. 27, 2020).
Also, Berger and Votaw reported that many ink products contain chemicals such as 1,1,2-trichloroethylene (TCE), o-dichlorobenzene, di-isobutyl phthalate (DIBP), phthalic anhydride, and octamethylcyclotetrasiloxane (D4). These existing chemicals have been designated by EPA as “high-priority” chemicals. These substances are currently undergoing TSCA Section 6 risk evaluation and may later become subject to new chemical-specific risk management rules (including potential bans). Manufacturers and importers of these substances in both “neat” and mixture form also are subject to substantial fee assessment under TSCA Section 26(b) to support EPA’s TSCA Section 6 risk evaluation efforts.
Gould pointed out that many of these new substances are being designed to be safer, “greener” and more sustainable from the perspective of human health and the environment compared to legacy materials that are not restricted in commerce. Yet, if EPA cannot make an affirmative determination of “not likely to present an unreasonable risk,” the newer, safer substances are regulated, making them less likely to be used as substitutes for older, established products.
“This is an odd paradox that was not foreseen by the creators of the new legislation and it will continue to have a negative impact on innovation throughout the American chemical industry,” Gould concluded.
