DAVID SAVASTANO, EDITOR01.24.23
Among the key regulatory concerns for the ink industry, the Toxic Substance Control Act (TSCA) continues to be a major challenge. TSCA has moved dramatically from its original notion to a more bureaucratic system that is bringing more chemicals under far greater scrutiny at a higher cost.
David Wawer, Color Pigments Manufacturers Association (CPMA) executive director, spoke about the challenges the pigment industry is seeing from TSCA, beginning with the length of time it takes to get any kind of decision.
“The Lautenberg Chemical Safety Act of 2016 (TSCA Reform) has created even greater regulatory challenges for the color pigments industry than those existing prior to 2016,” said Wawer. “Previously, new chemicals registrations (PMNs) took less than 180 days. Post-Lautenberg, new chemicals registration approvals have stretched to three years or more.”
George Fuchs, director – regulatory affairs and technology for the National Association of Printing Ink Manufacturers (NAPIM), said that among the latest changes at TSCA are higher fees and studies of exposure limits.
“The Environmental Protection Agency (EPA) is proposing to substantially increase fees to be paid by the chemical industry for reviewing commercial chemicals without justification for the increases. This will have an adverse financial impact on companies affected by TSCA sections 4 and 5,” Fuchs noted.
“EPA’s priority chemical program is beginning to propose employee exposure limits – an area historically regulated by OSHA for some of the priority chemicals,” Fuchs added. “OSHA has the staff, resources and experience in this area and would be a better fit for these efforts.”
Wawer added that the EPA has added requirements to companies for costly new chemical data studies before even evaluating the new chemistry.
“Innovation across the color pigments, specialty chemicals and other industries is being stifled by approval delays and imposition of higher fees to bring innovative chemistry to market in North America,” Wawer observed. “In practice, EPA’s PMN regulatory process under the Biden Administration has created significant barriers to chemistry innovation, in direct opposition to the administration’s executive orders set forth to encourage reshoring of industry from Asia to the United States.
“New regulatory cost barriers discouraging our respective industries’ innovation have also been proposed for 2023 through massive fee increases for TSCA programs,” he continued. “Higher fees for new chemicals registration, as well as the proposed 300% fee increases for risk evaluation of existing chemicals on the TSCA list, will only exacerbate movement of innovation to other countries in the USMCA region, such as Canada and Mexico.”
Wawer noted that a proposed $5.5 million upfront cost for risk evaluation, particularly for low volume, low margin chemistries, will only accelerate growth of manufacturing outside the United States.
“Additionally, companies that can absorb the high fees for risk evaluation (as well as Section 4 test orders) will ultimately pass these higher costs on to customers,” Wawer concluded. “Thus, the entire value chain, from printing ink, paints & coatings, packaging, to personal care product industries and more, will experience such increases, leading to even higher inflation to consumers.”
Shannon Gainey of RadTech, director of global regultory management of J.M. Huber, noted that in reality, there are several challenges for industry.
"The first is that most cases are still impacted by exceptional delays in the New Chemicals review process with little transparency regarding estimated timing," Gainey said. "Second, the EPA has essentially taken the position that they will not approve LVEs if new chemicals present risk. Many UV chemistries have moderate hazards which means there will be moderate risks, yet these can all be used safely with appropriate PPE and disposal controls. Unfortunately, this means most new UV chemistries will be forced to register via a full PMN, which costs more money and has unpredictable timing."
Gainey also pointed out that EPA has discussed raising fees again, proposing a potential PMN cost of ~$40,000.
"Unfortunately, many companies do not have this type of budget for new industrial chemicals," added Gainey. "Industrial chemicals do not typically yield the high margins available with other chemistries subject to other regulations, e.g., FIFRA, FDA, etc., so the proposed higher pricing will become a significant barrier to innovation."
The pigment industry has faced its share of problems with TSCA, beginning with PV29 and now heading to other pigments. What are the latest targets, and how is the procedure changing under TSCA for these pigments?
As head of the CPMA, Wawer knows first-hand how the pigment industry is being impacted by TSCA, as Pigment Violet 29 (PV 29) is under scrutiny. Wawer reported that EPA’s process for risk evaluation of existing chemicals on the TSCA Chemical Substance Inventory has resulted in an entirely new layer of costly regulations for manufacturing companies and for consumers.
“While risk evaluation of the first ten chemicals, including Pigment Violet 29, did not require payment of risk evaluation fees, it did result in hundreds of industry labor hours being diverted from manufacturing innovation to regulatory engagement with EPA,” he said.
“One of the lessons learned from the risk evaluation process is that none of the employees at EPA have any experience or understanding of specialty and batch chemical manufacturing,” Wawer added. “After being provided with onsite tours of specialty chemical facilities and color pigment manufacturing processes, EPA scientists seem to ignore such factual information and insight, as well as long-standing worker safety regulations when publishing its final risk evaluation report. The final report also created hypothetical conclusions about printing ink, paints & coatings, and plastics masterbatch manufacturing processes that are not based upon scientific facts.”
Wawer noted that the risk management process for Pigment Violet 29, expected to proceed in 2023, presents opportunities for the color pigments industry and its downstream customers to further educate EPA staff about factual realities of specialty and batch chemical manufacturing.
“Ultimate results of the risk management process will signify how the agency approaches risk evaluation for three color pigments on the Lautenberg Act High Priority Chemicals list,” said Wawer. “Specifically, Pigment Yellow 83, Pigment Yellow 65, and Pigment Red 52:1 are among the 93 chemical substances identified in the 2016 legislation as high priorities for EPA risk evaluation.
“New elements impacting risk evaluation of the three color pigments are significant risk evaluation fees, costly data studies, upfront engagement with customer industries, minimal EPA staff knowledge about the color pigments industry, very little understanding about specialty batch chemical manufacturing, and finally, a lack of EPA industrial hygiene staff, may only lead to poor outcomes and conclusions not substantiated by scientific and technical facts,” he concluded.
“Although PV29 is rarely if ever used in printing inks, however, identifying very low volume, low exposure substances like PV29 is concerning,” Fuchs observed.
“Although the federal regulatory initiatives are currently concerned with the PFAS impact on water quality, there is a rapidly growing number of states developing or passing legislation or implementing regulations prohibiting the use of organic/perflourinated compounds in packaging – food and non-food,” Fuchs said. “In many cases, the definitions used for PFAS in either the legislation or regulations would include PTFE.”
Wawer said that from the perspective of the color pigments industry, potential regulatory impacts are still to be determined of individual states’ legislation banning PFAS in specific products.
“Since PFAS legislation is not specific to color pigments products, but rather to specific consumer products, the Color Pigments Manufacturers Association will continue to monitor new legislation and partner with downstream customer trade associations to evaluate supply chain impacts,” added Wawer.
Along those lines, there are also a lot of different challenges from individual states (Prop. 65 in California, CONEG) as well as individual countries and regions.
CPMA’s Wawer said that a continuing challenge for the North American color pigments industry is compliance with California Proposition 65 labeling requirements, including complicating factors from downstream customers.
“Extreme nuances come into play from questions from such customers, particularly with respect to metals on the CA Prop 65 list,” Wawer added. “Not all customers are alike in their interpretations of CA Prop 65, and individual customers can create unique labeling requirements.
“In addition, the California State Legislature continues to enact legislation (i.e., PFAS) not directly related to color pigments, but which could be interpreted by customers to have a tangential relationship to color pigments,” he observed. “California Assembly Bill 1200 (PFAS), passed by the legislature in 2021, is a current example of the necessary reasons to monitor emerging legislation in California that impacts the color pigments industry.”
“Prop 65 and CONEG have been with us for many years,” Fuchs observed. “Today states are becoming increasingly active in the chemical regulatory area, dramatically complicating programs for compliance and limiting the number of materials that can be use in a product. The PFAS issue is a great example.”
Michael Gould, president of RadTech North America and technical key account manager for Rahn USA, said that recycling and sustainability are important as part of day-to-day business considerations among suppliers, formulators, converters and brand owners who operate within the energy curing industry.
“Multiple drivers are responsible for this, from greater consumer awareness of the need for more effective recycling and reduction of waste to greater emphasis among local regulators who desire to have greater control over the burdens of post-consumer waste,” Gould reported. “Local entities can tax packaging and containers to encourage a more sustainable life cycle for product packaging. If this trend evolves to state and federal levels, the net effect will be ‘compliance by mandate,’ possibly before the various industry players can address these issues with workable technical strategies.”
Gould said that awareness of this trend has resulted in priority attention being placed on greater understanding and management of product life cycles.
“Unfortunately, the ‘science’ of finding and assessing acceptable cradle to grave chemistries is still in a phase of exploration and negotiation,” Gould concluded. “There is not yet a clear consensus on how to manage these issues, though much attention is focused on operational definitions, measurement methods and understanding of the economic ramifications. 2023 will be a year during which much of this will evolve to a starting point from which industry can continue to improve.”
David Wawer, Color Pigments Manufacturers Association (CPMA) executive director, spoke about the challenges the pigment industry is seeing from TSCA, beginning with the length of time it takes to get any kind of decision.
“The Lautenberg Chemical Safety Act of 2016 (TSCA Reform) has created even greater regulatory challenges for the color pigments industry than those existing prior to 2016,” said Wawer. “Previously, new chemicals registrations (PMNs) took less than 180 days. Post-Lautenberg, new chemicals registration approvals have stretched to three years or more.”
George Fuchs, director – regulatory affairs and technology for the National Association of Printing Ink Manufacturers (NAPIM), said that among the latest changes at TSCA are higher fees and studies of exposure limits.
“The Environmental Protection Agency (EPA) is proposing to substantially increase fees to be paid by the chemical industry for reviewing commercial chemicals without justification for the increases. This will have an adverse financial impact on companies affected by TSCA sections 4 and 5,” Fuchs noted.
“EPA’s priority chemical program is beginning to propose employee exposure limits – an area historically regulated by OSHA for some of the priority chemicals,” Fuchs added. “OSHA has the staff, resources and experience in this area and would be a better fit for these efforts.”
Wawer added that the EPA has added requirements to companies for costly new chemical data studies before even evaluating the new chemistry.
“Innovation across the color pigments, specialty chemicals and other industries is being stifled by approval delays and imposition of higher fees to bring innovative chemistry to market in North America,” Wawer observed. “In practice, EPA’s PMN regulatory process under the Biden Administration has created significant barriers to chemistry innovation, in direct opposition to the administration’s executive orders set forth to encourage reshoring of industry from Asia to the United States.
“New regulatory cost barriers discouraging our respective industries’ innovation have also been proposed for 2023 through massive fee increases for TSCA programs,” he continued. “Higher fees for new chemicals registration, as well as the proposed 300% fee increases for risk evaluation of existing chemicals on the TSCA list, will only exacerbate movement of innovation to other countries in the USMCA region, such as Canada and Mexico.”
Wawer noted that a proposed $5.5 million upfront cost for risk evaluation, particularly for low volume, low margin chemistries, will only accelerate growth of manufacturing outside the United States.
“Additionally, companies that can absorb the high fees for risk evaluation (as well as Section 4 test orders) will ultimately pass these higher costs on to customers,” Wawer concluded. “Thus, the entire value chain, from printing ink, paints & coatings, packaging, to personal care product industries and more, will experience such increases, leading to even higher inflation to consumers.”
Shannon Gainey of RadTech, director of global regultory management of J.M. Huber, noted that in reality, there are several challenges for industry.
"The first is that most cases are still impacted by exceptional delays in the New Chemicals review process with little transparency regarding estimated timing," Gainey said. "Second, the EPA has essentially taken the position that they will not approve LVEs if new chemicals present risk. Many UV chemistries have moderate hazards which means there will be moderate risks, yet these can all be used safely with appropriate PPE and disposal controls. Unfortunately, this means most new UV chemistries will be forced to register via a full PMN, which costs more money and has unpredictable timing."
Gainey also pointed out that EPA has discussed raising fees again, proposing a potential PMN cost of ~$40,000.
"Unfortunately, many companies do not have this type of budget for new industrial chemicals," added Gainey. "Industrial chemicals do not typically yield the high margins available with other chemistries subject to other regulations, e.g., FIFRA, FDA, etc., so the proposed higher pricing will become a significant barrier to innovation."
The Pigment Industry and TSCA
The pigment industry has faced its share of problems with TSCA, beginning with PV29 and now heading to other pigments. What are the latest targets, and how is the procedure changing under TSCA for these pigments?As head of the CPMA, Wawer knows first-hand how the pigment industry is being impacted by TSCA, as Pigment Violet 29 (PV 29) is under scrutiny. Wawer reported that EPA’s process for risk evaluation of existing chemicals on the TSCA Chemical Substance Inventory has resulted in an entirely new layer of costly regulations for manufacturing companies and for consumers.
“While risk evaluation of the first ten chemicals, including Pigment Violet 29, did not require payment of risk evaluation fees, it did result in hundreds of industry labor hours being diverted from manufacturing innovation to regulatory engagement with EPA,” he said.
“One of the lessons learned from the risk evaluation process is that none of the employees at EPA have any experience or understanding of specialty and batch chemical manufacturing,” Wawer added. “After being provided with onsite tours of specialty chemical facilities and color pigment manufacturing processes, EPA scientists seem to ignore such factual information and insight, as well as long-standing worker safety regulations when publishing its final risk evaluation report. The final report also created hypothetical conclusions about printing ink, paints & coatings, and plastics masterbatch manufacturing processes that are not based upon scientific facts.”
Wawer noted that the risk management process for Pigment Violet 29, expected to proceed in 2023, presents opportunities for the color pigments industry and its downstream customers to further educate EPA staff about factual realities of specialty and batch chemical manufacturing.
“Ultimate results of the risk management process will signify how the agency approaches risk evaluation for three color pigments on the Lautenberg Act High Priority Chemicals list,” said Wawer. “Specifically, Pigment Yellow 83, Pigment Yellow 65, and Pigment Red 52:1 are among the 93 chemical substances identified in the 2016 legislation as high priorities for EPA risk evaluation.
“New elements impacting risk evaluation of the three color pigments are significant risk evaluation fees, costly data studies, upfront engagement with customer industries, minimal EPA staff knowledge about the color pigments industry, very little understanding about specialty batch chemical manufacturing, and finally, a lack of EPA industrial hygiene staff, may only lead to poor outcomes and conclusions not substantiated by scientific and technical facts,” he concluded.
“Although PV29 is rarely if ever used in printing inks, however, identifying very low volume, low exposure substances like PV29 is concerning,” Fuchs observed.
PFAS Under the Microscope
PFAS is another area that is under scrutiny, and the focus on PFAS will impact the ink supply chain. For example, in December 2022, 3M announced it was exiting the PFAS field. NAPIM’s Fuchs noted that the PFAS issue is becoming increasing problematic for ink manufacturers.“Although the federal regulatory initiatives are currently concerned with the PFAS impact on water quality, there is a rapidly growing number of states developing or passing legislation or implementing regulations prohibiting the use of organic/perflourinated compounds in packaging – food and non-food,” Fuchs said. “In many cases, the definitions used for PFAS in either the legislation or regulations would include PTFE.”
Wawer said that from the perspective of the color pigments industry, potential regulatory impacts are still to be determined of individual states’ legislation banning PFAS in specific products.
“Since PFAS legislation is not specific to color pigments products, but rather to specific consumer products, the Color Pigments Manufacturers Association will continue to monitor new legislation and partner with downstream customer trade associations to evaluate supply chain impacts,” added Wawer.
Along those lines, there are also a lot of different challenges from individual states (Prop. 65 in California, CONEG) as well as individual countries and regions.
CPMA’s Wawer said that a continuing challenge for the North American color pigments industry is compliance with California Proposition 65 labeling requirements, including complicating factors from downstream customers.
“Extreme nuances come into play from questions from such customers, particularly with respect to metals on the CA Prop 65 list,” Wawer added. “Not all customers are alike in their interpretations of CA Prop 65, and individual customers can create unique labeling requirements.
“In addition, the California State Legislature continues to enact legislation (i.e., PFAS) not directly related to color pigments, but which could be interpreted by customers to have a tangential relationship to color pigments,” he observed. “California Assembly Bill 1200 (PFAS), passed by the legislature in 2021, is a current example of the necessary reasons to monitor emerging legislation in California that impacts the color pigments industry.”
“Prop 65 and CONEG have been with us for many years,” Fuchs observed. “Today states are becoming increasingly active in the chemical regulatory area, dramatically complicating programs for compliance and limiting the number of materials that can be use in a product. The PFAS issue is a great example.”
Recycling and Sustainability
There is a great deal of interest in the end of life of products, such as reuse and recycling, and sustainability in general.Michael Gould, president of RadTech North America and technical key account manager for Rahn USA, said that recycling and sustainability are important as part of day-to-day business considerations among suppliers, formulators, converters and brand owners who operate within the energy curing industry.
“Multiple drivers are responsible for this, from greater consumer awareness of the need for more effective recycling and reduction of waste to greater emphasis among local regulators who desire to have greater control over the burdens of post-consumer waste,” Gould reported. “Local entities can tax packaging and containers to encourage a more sustainable life cycle for product packaging. If this trend evolves to state and federal levels, the net effect will be ‘compliance by mandate,’ possibly before the various industry players can address these issues with workable technical strategies.”
Gould said that awareness of this trend has resulted in priority attention being placed on greater understanding and management of product life cycles.
“Unfortunately, the ‘science’ of finding and assessing acceptable cradle to grave chemistries is still in a phase of exploration and negotiation,” Gould concluded. “There is not yet a clear consensus on how to manage these issues, though much attention is focused on operational definitions, measurement methods and understanding of the economic ramifications. 2023 will be a year during which much of this will evolve to a starting point from which industry can continue to improve.”
