Implications of New Lautenberg Act’s Sweeping Changes to Toxic Substances Control Act – June 23, 2016
PerkinsCoie
Description
Implications of New Lautenberg Act’s Sweeping Changes to Toxic
Substances Control Act
06.23.2016 | UPDATES
President Obama signed HR 2576, the Frank Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act),
into law on June 22, 2016. The Lautenberg Act makes significant changes to the Toxic Substances Control Act (TSCA)
and is the largest revision to existing environmental law since the 1990s. It will modernize the last of the environmental
statutes passed in the 1960s and 1970s. These changes to TSCA have important implications for chemical
manufacturers and for manufacturers and retailers of consumer goods who are required by law to test for and report on
chemicals of concern in their products.
TSCA and State Chemical Regulation Laws
TSCA, 15 U.S.C.
§ 2601 et. seq. was passed in 1976 and has not undergone significant revision prior to the Lautenberg Act.
The law gave EPA authority to regulate the manufacture, use and disposal of chemicals and could require companies to test existing chemical substances to evaluate effects on human health and the environment. EPA could also regulate new chemicals or new uses of existing chemicals before their introduction into the market. States were generally free to enact their own restrictions on chemicals where EPA had not acted. TSCA has long been criticized for provisions that made EPA’s use of its authorities difficult and time-consuming.
For example, EPA was required to make risk and exposure determinations before initiating formal rulemaking and before it could require testing of existing chemicals. EPA often lacked information to order the very chemical testing necessary to gather the information needed. EPA tested fewer than 300 of the estimated 62,000 chemicals on the market in 1976. For new chemicals, EPA was required to make a risk determination within 90 days, often based on very limited data.
At this time, 84,000 chemicals are on EPA’s TSCA registry; but only 200 underwent testing before introduction to the market. EPA has banned five chemicals (PCBs (polychlorinated biphenyls), fully halogenated chlorofluoroalkanes, dioxin, asbestos and hexavalent chromium) since 1976. Because of these limits on EPA authority, many states took advantage of the weak preemption provision in TSCA to pass their own laws that regulate or ban chemicals. As more states enacted chemical safety laws, the industry became more concerned about the confusing patchwork set of laws with which they had to comply. TSCA Reform The Lautenberg Act was the product of long, bipartisan and bicameral negotiations.
Although no one was completely satisfied, the legislation provides industries with greater certainty, more uniform standard and strengthened preemption, giving EPA stronger authority while leaving some room for state action. Prioritization, Risk Evaluations and Regulation of Chemicals The Lautenberg Act substantially revises Section 6 of TSCA by prioritizing the review of chemicals, removing the “least burdensome requirement” and simplifying the EPA’s rulemaking process. Within one year, EPA must establish by rule a risk-based screening process for designating chemicals as high-priority or low-priority, taking into consideration a number of hazard and exposure factors. EPA must designate a chemical as high-priority if the substance may present an unreasonable risk of injury to health or the environment. EPA may no longer consider costs or other non-risk factors in making this determination, and the agency must conduct a risk evaluation on any chemical designated as high-priority. The Lautenberg Act establishes an overarching concept—“conditions of use”—by which EPA’s risk evaluations are to be governed.
This determination shapes EPA’s risk evaluations, where EPA now has the power to restrict chemicals for certain uses or to exempt particular uses from regulation. If the EPA determines that a chemical presents an unreasonable risk of injury to health or the environment, the agency has two years to issue a final rule that regulates use of the chemical. . Within 180 days, EPA must ensure that initial risk evaluations are conducted on 10 priority chemicals. Additional risk evaluations must also proceed along a set schedule, with EPA conducting risk evaluations on at least 20 high-priority substances within 3.5 years after the date the law is enacted. Companies will have the opportunity to submit information to the EPA before the agency deems the chemical high-priority and before a final rule regulating the chemical is issued. Chemical Testing EPA also has additional testing authority. Chemical manufacturers can now be required to conduct testing.
EPA may now issue orders or consent agreements that require manufacturers to conduct chemical testing without entering into rulemaking or proving that the chemical poses an exposure risk. New Chemical Review and Reporting Requirements EPA must review all new chemicals by requiring an affirmative safety finding before the chemical can be sold. Previously, chemical manufacturers and importers only had to notify EPA 90 days prior to manufacturing or importing the chemical, but EPA was not required to act upon this information. In the face of inaction by EPA, the chemical manufacturer or importer could proceed. However, under the TSCA amendments, EPA is now required to review all new chemicals and significant new uses and to make one of three determinations: 1.
That the chemical must be regulated because it presents an unreasonable risk of injury to health or the environment; 2. That more information is necessary to evaluate the chemical and that a substance may present an unreasonable risk but more information is necessary, or the chemical will be produced in substantial quantities such that the chemical will substantially enter the environment or cause significant human exposure; or 3. That the new chemical or new use is not likely to present an unreasonable risk, in which case the chemical at issue can be manufactured or processed. If EPA makes any one of the first two determinations, it must regulate the chemical, implement a significant new use rule or explain why it is choosing not to issue a rule. Preemption The preemption issue was long debated by the stakeholders.
The Lautenberg Act largely preempts future chemical regulation by states but allows existing state laws to remain in effect. State actions taken before April 22, 2016 or any action taken pursuant to state law that was in effect on August 31, 2003 will remain in effect under the new law. In addition to these grandfathering provisions, the law creates a “high-priority pause” whereby states are preempted from regulating a particular chemical while EPA is considering whether that chemical presents an unreasonable risk.
States are prohibited from establishing or continuing to enforce statutes or administrative actions that would: require development of information already required under TSCA; prohibit or restrict a chemical after EPA has decided the chemical does not pose an unreasonable risk, consistent with the scope of the risk evaluation; or duplicate notification of use. Confidential Business Information (CBI) The Lautenberg Act makes it more difficult for companies to protect CBI from disclosure. Information from health and safety studies is not precluded. Information designated CBI may be disclosed to state or tribal governments, to health or environmental professionals employed by federal or state agencies or tribal governments, and to treating physicians or nurses.
To receive CBI protection, a company must meet certain requirements and provide adequate written substantiation for its claim. Any CBI protection granted by EPA lasts only 10 years. Implications of the Lautenberg Act These changes have important implications for chemical manufacturers and for manufacturers and retailers of consumer products. Chemical manufacturers wishing to introduce new substances to the market will experience more stringent review by EPA, and the CBI associated with such new substances will be harder to protect. Chemicals in consumer products have been a focus of state regulatory activity in the past several years.
State laws . have required consumer product manufacturers to test for and report on chemicals of concern in their products. States have also banned certain chemicals from use in consumer products sold in those states. TSCA’s preemption changes essentially allow state laws on the books before April 2016 to stand. However, going forward, states will be significantly affected as they will not be able to pass new laws or enforce existing laws after EPA determines a chemical’s risk.
If EPA determines a chemical does not present a risk, states are preempted from taking action inconsistent with EPA’s decision. It will take some time to see how states with chemical regulation programs will respond to the new TSCA. While several states continued to oppose the final preemption provisions in TSCA, with EPA’s new authority it is likely that many of these states will see new chemical regulation statutes and rules and enforcement as a lower priority. However, some states have indicated they may take additional actions in the near-term before EPA uses its new authority to conduct risk reviews for existing chemicals. © 2016 Perkins Coie LLP CONTACTS Michael Dunning Partner Seattle D +1.206.359.3464 Julie A.
Wilson-McNerney Associate Seattle D +1.206.359.8000 Related Services Environment and Natural Resources Retail & Consumer Products © 2016 Perkins Coie LLP .
§ 2601 et. seq. was passed in 1976 and has not undergone significant revision prior to the Lautenberg Act.
The law gave EPA authority to regulate the manufacture, use and disposal of chemicals and could require companies to test existing chemical substances to evaluate effects on human health and the environment. EPA could also regulate new chemicals or new uses of existing chemicals before their introduction into the market. States were generally free to enact their own restrictions on chemicals where EPA had not acted. TSCA has long been criticized for provisions that made EPA’s use of its authorities difficult and time-consuming.
For example, EPA was required to make risk and exposure determinations before initiating formal rulemaking and before it could require testing of existing chemicals. EPA often lacked information to order the very chemical testing necessary to gather the information needed. EPA tested fewer than 300 of the estimated 62,000 chemicals on the market in 1976. For new chemicals, EPA was required to make a risk determination within 90 days, often based on very limited data.
At this time, 84,000 chemicals are on EPA’s TSCA registry; but only 200 underwent testing before introduction to the market. EPA has banned five chemicals (PCBs (polychlorinated biphenyls), fully halogenated chlorofluoroalkanes, dioxin, asbestos and hexavalent chromium) since 1976. Because of these limits on EPA authority, many states took advantage of the weak preemption provision in TSCA to pass their own laws that regulate or ban chemicals. As more states enacted chemical safety laws, the industry became more concerned about the confusing patchwork set of laws with which they had to comply. TSCA Reform The Lautenberg Act was the product of long, bipartisan and bicameral negotiations.
Although no one was completely satisfied, the legislation provides industries with greater certainty, more uniform standard and strengthened preemption, giving EPA stronger authority while leaving some room for state action. Prioritization, Risk Evaluations and Regulation of Chemicals The Lautenberg Act substantially revises Section 6 of TSCA by prioritizing the review of chemicals, removing the “least burdensome requirement” and simplifying the EPA’s rulemaking process. Within one year, EPA must establish by rule a risk-based screening process for designating chemicals as high-priority or low-priority, taking into consideration a number of hazard and exposure factors. EPA must designate a chemical as high-priority if the substance may present an unreasonable risk of injury to health or the environment. EPA may no longer consider costs or other non-risk factors in making this determination, and the agency must conduct a risk evaluation on any chemical designated as high-priority. The Lautenberg Act establishes an overarching concept—“conditions of use”—by which EPA’s risk evaluations are to be governed.
This determination shapes EPA’s risk evaluations, where EPA now has the power to restrict chemicals for certain uses or to exempt particular uses from regulation. If the EPA determines that a chemical presents an unreasonable risk of injury to health or the environment, the agency has two years to issue a final rule that regulates use of the chemical. . Within 180 days, EPA must ensure that initial risk evaluations are conducted on 10 priority chemicals. Additional risk evaluations must also proceed along a set schedule, with EPA conducting risk evaluations on at least 20 high-priority substances within 3.5 years after the date the law is enacted. Companies will have the opportunity to submit information to the EPA before the agency deems the chemical high-priority and before a final rule regulating the chemical is issued. Chemical Testing EPA also has additional testing authority. Chemical manufacturers can now be required to conduct testing.
EPA may now issue orders or consent agreements that require manufacturers to conduct chemical testing without entering into rulemaking or proving that the chemical poses an exposure risk. New Chemical Review and Reporting Requirements EPA must review all new chemicals by requiring an affirmative safety finding before the chemical can be sold. Previously, chemical manufacturers and importers only had to notify EPA 90 days prior to manufacturing or importing the chemical, but EPA was not required to act upon this information. In the face of inaction by EPA, the chemical manufacturer or importer could proceed. However, under the TSCA amendments, EPA is now required to review all new chemicals and significant new uses and to make one of three determinations: 1.
That the chemical must be regulated because it presents an unreasonable risk of injury to health or the environment; 2. That more information is necessary to evaluate the chemical and that a substance may present an unreasonable risk but more information is necessary, or the chemical will be produced in substantial quantities such that the chemical will substantially enter the environment or cause significant human exposure; or 3. That the new chemical or new use is not likely to present an unreasonable risk, in which case the chemical at issue can be manufactured or processed. If EPA makes any one of the first two determinations, it must regulate the chemical, implement a significant new use rule or explain why it is choosing not to issue a rule. Preemption The preemption issue was long debated by the stakeholders.
The Lautenberg Act largely preempts future chemical regulation by states but allows existing state laws to remain in effect. State actions taken before April 22, 2016 or any action taken pursuant to state law that was in effect on August 31, 2003 will remain in effect under the new law. In addition to these grandfathering provisions, the law creates a “high-priority pause” whereby states are preempted from regulating a particular chemical while EPA is considering whether that chemical presents an unreasonable risk.
States are prohibited from establishing or continuing to enforce statutes or administrative actions that would: require development of information already required under TSCA; prohibit or restrict a chemical after EPA has decided the chemical does not pose an unreasonable risk, consistent with the scope of the risk evaluation; or duplicate notification of use. Confidential Business Information (CBI) The Lautenberg Act makes it more difficult for companies to protect CBI from disclosure. Information from health and safety studies is not precluded. Information designated CBI may be disclosed to state or tribal governments, to health or environmental professionals employed by federal or state agencies or tribal governments, and to treating physicians or nurses.
To receive CBI protection, a company must meet certain requirements and provide adequate written substantiation for its claim. Any CBI protection granted by EPA lasts only 10 years. Implications of the Lautenberg Act These changes have important implications for chemical manufacturers and for manufacturers and retailers of consumer products. Chemical manufacturers wishing to introduce new substances to the market will experience more stringent review by EPA, and the CBI associated with such new substances will be harder to protect. Chemicals in consumer products have been a focus of state regulatory activity in the past several years.
State laws . have required consumer product manufacturers to test for and report on chemicals of concern in their products. States have also banned certain chemicals from use in consumer products sold in those states. TSCA’s preemption changes essentially allow state laws on the books before April 2016 to stand. However, going forward, states will be significantly affected as they will not be able to pass new laws or enforce existing laws after EPA determines a chemical’s risk.
If EPA determines a chemical does not present a risk, states are preempted from taking action inconsistent with EPA’s decision. It will take some time to see how states with chemical regulation programs will respond to the new TSCA. While several states continued to oppose the final preemption provisions in TSCA, with EPA’s new authority it is likely that many of these states will see new chemical regulation statutes and rules and enforcement as a lower priority. However, some states have indicated they may take additional actions in the near-term before EPA uses its new authority to conduct risk reviews for existing chemicals. © 2016 Perkins Coie LLP CONTACTS Michael Dunning Partner Seattle D +1.206.359.3464 Julie A.
Wilson-McNerney Associate Seattle D +1.206.359.8000 Related Services Environment and Natural Resources Retail & Consumer Products © 2016 Perkins Coie LLP .
