01.20.17
In January 2017, the U.S. Environmental Protection Agency (EPA) proposed three major regulations that would implement amendments to the Toxic Substances Control Act (TSCA) pursuant to the Frank L. Lautenberg Chemical Safety for the 21st Century Act: the prioritization proposed rule, risk evaluation proposed rule, and inventory reset proposed rule. These proposed rules will be critical for EPA’s implementation of the new TSCA program for years to come.
On Jan. 16, EPA released its proposed reporting rule under the amended TSCA to “reset” the TSCA inventory of thousands of chemicals in the United States, both manufactured domestically and imported. As amended by the Frank R. Lautenberg for the 21st Century Act, under TSCA Section 8, EPA is required to finalize by June 22, 2017, a regulation that sorts the TSCA inventory into “active” and “inactive” substances. Under the statute, EPA is obligated to first designate chemicals reported under the 2016 CDR as an interim list of active substances.
The statute requires EPA to promulgate a rule requiring manufacturers/importers to notify EPA within six months of each chemical substance they have manufactured or processed for non-exempt commercial purposes as far back as 10 years ago. Substances reported to EPA will be “active” substances, and the rest will be “inactive.” Chemical processors may notify EPA about chemicals they have processed over the past 10 years to ensure those chemicals are also on the updated, active inventory. The proposed rule does not require processors to notify the agency.
Manufacturers will have 180 days after EPA issues its final inventory update rule to notify the agency of chemicals they have made over the last 10 years.
EPA is also proposing a process for chemical manufacturers and processors to use for asking the agency to move a chemical from the inactive inventory to the active one.
Notably, only chemicals on the active TSCA inventory may be made, imported, distributed, sold, and used. EPA will review the chemicals on the active inventory, determine which are high or low priorities for risk assessment, and evaluate the risks of high priority chemicals. The risk evaluations could trigger regulations to control chemical uses that pose an unreasonable risk to people or the environment.
According to the proposal, manufacturers and processors of chemical substances listed on the non-confidential portion of the TSCA inventory would not have to tell the agency they made a particular chemical if they or another manufacturer had already done so by providing the EPA information required under the 2012 or 2016 Chemical Data Reporting rules. The Chemical Data Reporting rules required companies that produced certain volumes of a chemical (generally 25,000 pounds or more) submit to the EPA information such as the identity of the chemical they make, the volume made or imported, how the chemical was used and the extent to which workers were exposed to it.
EPA is accepting comments on its proposed rule through March 14, 2017.
Also on Jan. 16, EPA released its proposed rule to establish a process and criteria for identifying high-priority and low-priority chemicals for evaluation. A chemical designated as “High-Priority” must undergo evaluation. Chemicals designated as “Low-Priority” are not required to undergo further evaluation. Comments are due to EPA on March 20, 2017. Also, EPA released its proposed rule to establish EPA’s process for evaluating the risks of high-priority chemicals. EPA identifies steps in the risk evaluation process, including publishing the scope of the assessment, assessing hazard and exposures, and characterizing and determining risks. This rule also outlines how the agency intends to seek public input on specific chemical evaluations. Comments are due within 60 days of publication in the Federal Register.
On Jan. 16, EPA released its proposed reporting rule under the amended TSCA to “reset” the TSCA inventory of thousands of chemicals in the United States, both manufactured domestically and imported. As amended by the Frank R. Lautenberg for the 21st Century Act, under TSCA Section 8, EPA is required to finalize by June 22, 2017, a regulation that sorts the TSCA inventory into “active” and “inactive” substances. Under the statute, EPA is obligated to first designate chemicals reported under the 2016 CDR as an interim list of active substances.
The statute requires EPA to promulgate a rule requiring manufacturers/importers to notify EPA within six months of each chemical substance they have manufactured or processed for non-exempt commercial purposes as far back as 10 years ago. Substances reported to EPA will be “active” substances, and the rest will be “inactive.” Chemical processors may notify EPA about chemicals they have processed over the past 10 years to ensure those chemicals are also on the updated, active inventory. The proposed rule does not require processors to notify the agency.
Manufacturers will have 180 days after EPA issues its final inventory update rule to notify the agency of chemicals they have made over the last 10 years.
EPA is also proposing a process for chemical manufacturers and processors to use for asking the agency to move a chemical from the inactive inventory to the active one.
Notably, only chemicals on the active TSCA inventory may be made, imported, distributed, sold, and used. EPA will review the chemicals on the active inventory, determine which are high or low priorities for risk assessment, and evaluate the risks of high priority chemicals. The risk evaluations could trigger regulations to control chemical uses that pose an unreasonable risk to people or the environment.
According to the proposal, manufacturers and processors of chemical substances listed on the non-confidential portion of the TSCA inventory would not have to tell the agency they made a particular chemical if they or another manufacturer had already done so by providing the EPA information required under the 2012 or 2016 Chemical Data Reporting rules. The Chemical Data Reporting rules required companies that produced certain volumes of a chemical (generally 25,000 pounds or more) submit to the EPA information such as the identity of the chemical they make, the volume made or imported, how the chemical was used and the extent to which workers were exposed to it.
EPA is accepting comments on its proposed rule through March 14, 2017.
Also on Jan. 16, EPA released its proposed rule to establish a process and criteria for identifying high-priority and low-priority chemicals for evaluation. A chemical designated as “High-Priority” must undergo evaluation. Chemicals designated as “Low-Priority” are not required to undergo further evaluation. Comments are due to EPA on March 20, 2017. Also, EPA released its proposed rule to establish EPA’s process for evaluating the risks of high-priority chemicals. EPA identifies steps in the risk evaluation process, including publishing the scope of the assessment, assessing hazard and exposures, and characterizing and determining risks. This rule also outlines how the agency intends to seek public input on specific chemical evaluations. Comments are due within 60 days of publication in the Federal Register.
