David Savastano, Editor05.25.16
Forty years ago, the US Congress passed the Toxic Substances Control Act (TSCA). Administered by the US Environmental Protection Agency (EPA), TSCA was designed to regulate the introduction of new or already existing chemicals; all previous chemicals were considered to be safe, and were grandfathered in. When a company looked to introduce a new chemical, it would have to file information with the EPA.
There are a few problems here, of course, not the least of which was that TSCA had never been updated or modernized. This, in turn, has led state governments to fill the void, creating a patchwork quilt of regulations that make matters difficult for manufacturers.
Theer were a few attempts to modernize TSCA, and in 2015, “The Frank R. Lautenberg Chemical Safety for the 21st Century Act” was passed by the US Senate, and the “TSCA Modernization Act of 2015” was approved by the US House of Representatives. President Barack Obama has signaled he will sign the legislation.
There were some differences between the bills, which needed to be reconciled, and the bills were delayed. There were some serious, real concerns that TSCA reform would be derailed despite the support of industry and many environmental groups.
To the surprise of many, it looks like TSCA reform is on the verge of passage. The US House of Representatives voted 403-12 to approve the bill, and the US Senate is expected to do likewise as early as today.
The chemical industry has supported reform for a variety of reasons, and the National Association of Printing Ink Manufacturers (NAPIM) is in agreement on this. George Fuchs, directory regulatory affairs and technology for NAPIM, said this is a much-needed reform that will benefit the ink and chemical industries as well as consumers and the environment.
“I’m really surprised,” said Fuchs. “The House and Senate bills were so far apart, but they seem to have set aside their differences. I’m really happy about this.
“The biggest concern for NAPIM and the whole chemical industry was the issue of preemption,” Fuchs added. “Large companies often have manufacturing sites in multiple states, and it becomes very burdensome to comply with different state laws on risk management, risk evaluation, testing, reporting, trade secrets and more.”
“This is a truly historic moment for a major piece of environmental legislation,” said Lawrence Sloan, Specialty Chemical Manufacturing Association (SOCMA) president and CEO, in a statement. “SOCMA and the specialty chemical companies that we represent have been longtime stakeholders in the TSCA reform debate. SOCMA looks forward to swift passage in the Senate and President Obama’s signature on this final bill.”
“This deal is a breakthrough that combines the strongest elements of the House and Senate bills, benefiting both manufacturers and consumers and eliminating regulatory uncertainty,” noted Aric Newhouse, National Association of Manufacturers SVP of policy and government relations, in a statement. “Manufacturers have been calling for TSCA reform for years.”
Here are some of the highlights of the compromise TSCA reform bill that Fuchs noted, along with his thoughts on the issues:
• Existing Chemicals: The House and Senate bills and the compromise text approach this problem similarly: by bifurcating the chemical regulation process into two steps (risk evaluation of a chemical and risk management of chemicals found to be problematic).
– Risk Evaluation: The first step to deciding whether regulation of a chemical is warranted is a scientific evaluation of the risk posed by a chemical, looking at its hazards and exposures without considering cost or other non-risk factors. If that analysis indicates that a chemical’s use presents an unreasonable risk, including to a vulnerable or susceptible population, then EPA will turn to the second step, a rulemaking to manage the risk.
– Risk Management: Once EPA decides a chemical poses an unreasonable risk, the agency is required to issue a risk management rule, ranging from minimum labeling or notice requirements to an outright ban. In choosing regulatory options EPA must consider the effects of a chemical on health and the environment, the chemical’s benefits, and economic consequences of the regulation including effects on the national economy, small business, and technology innovation.
• New Chemical: The EPA must make an affirmative determination (4 parameters) regarding safety without regard to cost.
– (1) presents an unreasonable risk (in which case EPA must immediately take regulatory action under current law subsection (f));
– (2) may present an unreasonable risk , is made in large quantities, or there isn’t enough information to make a determination (which would trigger order requirements under subsection (e));
– (3) is likely not to present a risk under the conditions of use (in which case manufacture may begin); or
– (4) is a subset of option #3, a low hazard, and manufacture may begin.
• Chemical Test: Under the existing law, TSCA Section 4 provides EPA sweeping authority to require testing of new and existing chemicals under a wide variety of circumstances so long as EPA has a reasonable basis for concern about the chemical.
The compromise text in the new law maintains existing law, but also specifies key points in the evaluation and regulatory process where EPA may order testing (e.g. prioritization for risk evaluation and the risk evaluation itself). In addition, the compromise text reduces animal testing required under TSCA.
•Confidential Business Information: EPA must continue protecting trade secrets submitted to it for 10 years (same as existing law), including when disclosure of proprietary chemical formulas would reveal secrets about the chemical manufacturing process. The compromise text adopts the Senate’s system to claim, substantiate and re-substantiate, review, and adjudicate claims for protection of trade secrets.
• State/Federal Relationship
This is complicated issue but here’s a basic summary of where we ended up: preemption under the new law begins with a general rule (subject to later provisions saving certain state laws) that states and local governments may not (1) duplicate federal information developments requirements, (2) restrict a chemical that EPA’s scientific risk evaluation found does not present an unreasonable risk, EPA has published risk management regulation; or required notification for a significant new use or a new chemical. Preemption begins when the administrator defines the scope of a risk evaluation and ends either 30 months after that or when a risk evaluation is completed, whichever is earlier. This provision does not restrict state authority to continue enforcing a law enacted prior to the risk evaluation scoping, but this does not allow a state to enforce a new restriction established after the risk evaluation scoping. Federal preemption applies only to the scope of the risk evaluation or to the significant new uses under section 5.
For more information on the TSCA reform bill, please contact George Fuchs at gfuchs@napim.org.
There are a few problems here, of course, not the least of which was that TSCA had never been updated or modernized. This, in turn, has led state governments to fill the void, creating a patchwork quilt of regulations that make matters difficult for manufacturers.
Theer were a few attempts to modernize TSCA, and in 2015, “The Frank R. Lautenberg Chemical Safety for the 21st Century Act” was passed by the US Senate, and the “TSCA Modernization Act of 2015” was approved by the US House of Representatives. President Barack Obama has signaled he will sign the legislation.
There were some differences between the bills, which needed to be reconciled, and the bills were delayed. There were some serious, real concerns that TSCA reform would be derailed despite the support of industry and many environmental groups.
To the surprise of many, it looks like TSCA reform is on the verge of passage. The US House of Representatives voted 403-12 to approve the bill, and the US Senate is expected to do likewise as early as today.
The chemical industry has supported reform for a variety of reasons, and the National Association of Printing Ink Manufacturers (NAPIM) is in agreement on this. George Fuchs, directory regulatory affairs and technology for NAPIM, said this is a much-needed reform that will benefit the ink and chemical industries as well as consumers and the environment.
“I’m really surprised,” said Fuchs. “The House and Senate bills were so far apart, but they seem to have set aside their differences. I’m really happy about this.
“The biggest concern for NAPIM and the whole chemical industry was the issue of preemption,” Fuchs added. “Large companies often have manufacturing sites in multiple states, and it becomes very burdensome to comply with different state laws on risk management, risk evaluation, testing, reporting, trade secrets and more.”
“This is a truly historic moment for a major piece of environmental legislation,” said Lawrence Sloan, Specialty Chemical Manufacturing Association (SOCMA) president and CEO, in a statement. “SOCMA and the specialty chemical companies that we represent have been longtime stakeholders in the TSCA reform debate. SOCMA looks forward to swift passage in the Senate and President Obama’s signature on this final bill.”
“This deal is a breakthrough that combines the strongest elements of the House and Senate bills, benefiting both manufacturers and consumers and eliminating regulatory uncertainty,” noted Aric Newhouse, National Association of Manufacturers SVP of policy and government relations, in a statement. “Manufacturers have been calling for TSCA reform for years.”
Here are some of the highlights of the compromise TSCA reform bill that Fuchs noted, along with his thoughts on the issues:
• Existing Chemicals: The House and Senate bills and the compromise text approach this problem similarly: by bifurcating the chemical regulation process into two steps (risk evaluation of a chemical and risk management of chemicals found to be problematic).
– Risk Evaluation: The first step to deciding whether regulation of a chemical is warranted is a scientific evaluation of the risk posed by a chemical, looking at its hazards and exposures without considering cost or other non-risk factors. If that analysis indicates that a chemical’s use presents an unreasonable risk, including to a vulnerable or susceptible population, then EPA will turn to the second step, a rulemaking to manage the risk.
– Risk Management: Once EPA decides a chemical poses an unreasonable risk, the agency is required to issue a risk management rule, ranging from minimum labeling or notice requirements to an outright ban. In choosing regulatory options EPA must consider the effects of a chemical on health and the environment, the chemical’s benefits, and economic consequences of the regulation including effects on the national economy, small business, and technology innovation.
• New Chemical: The EPA must make an affirmative determination (4 parameters) regarding safety without regard to cost.
– (1) presents an unreasonable risk (in which case EPA must immediately take regulatory action under current law subsection (f));
– (2) may present an unreasonable risk , is made in large quantities, or there isn’t enough information to make a determination (which would trigger order requirements under subsection (e));
– (3) is likely not to present a risk under the conditions of use (in which case manufacture may begin); or
– (4) is a subset of option #3, a low hazard, and manufacture may begin.
• Chemical Test: Under the existing law, TSCA Section 4 provides EPA sweeping authority to require testing of new and existing chemicals under a wide variety of circumstances so long as EPA has a reasonable basis for concern about the chemical.
The compromise text in the new law maintains existing law, but also specifies key points in the evaluation and regulatory process where EPA may order testing (e.g. prioritization for risk evaluation and the risk evaluation itself). In addition, the compromise text reduces animal testing required under TSCA.
•Confidential Business Information: EPA must continue protecting trade secrets submitted to it for 10 years (same as existing law), including when disclosure of proprietary chemical formulas would reveal secrets about the chemical manufacturing process. The compromise text adopts the Senate’s system to claim, substantiate and re-substantiate, review, and adjudicate claims for protection of trade secrets.
• State/Federal Relationship
This is complicated issue but here’s a basic summary of where we ended up: preemption under the new law begins with a general rule (subject to later provisions saving certain state laws) that states and local governments may not (1) duplicate federal information developments requirements, (2) restrict a chemical that EPA’s scientific risk evaluation found does not present an unreasonable risk, EPA has published risk management regulation; or required notification for a significant new use or a new chemical. Preemption begins when the administrator defines the scope of a risk evaluation and ends either 30 months after that or when a risk evaluation is completed, whichever is earlier. This provision does not restrict state authority to continue enforcing a law enacted prior to the risk evaluation scoping, but this does not allow a state to enforce a new restriction established after the risk evaluation scoping. Federal preemption applies only to the scope of the risk evaluation or to the significant new uses under section 5.
For more information on the TSCA reform bill, please contact George Fuchs at gfuchs@napim.org.