Chemical Compliance and the Modernized Toxic Substances Control Act (TSCA)

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Preparing for What’s Ahead: Chemical Compliance and the Modernized Toxic Substances Control Act (TSCA)

Although not quite a law yet, the Frank R. Lautenberg Chemical Safety for the 21st Century Act (the Act) is expected to go into effect this month. It will substantially update the TSCA law first promulgated in 1976. The Act took years of negotiation and compromise for both houses of Congress, industry, and consumer advocates to agree on a comprehensive set of legal provisions that will fundamentally change how chemicals are regulated in this country. Except for those found in food, drugs, and pesticides, TSCA regulates chemicals in products we use every day, and the Act is expected to provide more certainty for consumers, states, and the chemical industry regarding how chemical risks will be evaluated and managed by the US Environmental Protection Agency (EPA).

Once signed into law by President Obama, the amended TSCA law will go into effect immediately. Implementation of new regulations will take time, and we expect extensive debate during the ensuing notice and comment periods. However, US chemical manufacturers, importers, and processors should take action now to prepare.

Assuming the amended law is signed this month, the “TSCA Inventory Reset” rule is expected to go into effect as soon as June of 2017. This rule requires that manufacturers and importers report the following information to EPA within 6 months after the “Reset” rule is promulgated (which could be as soon as December 2017):

  • a list of all chemicals they have manufactured or imported in the previous 10 years; and
  • whether the identities of chemicals listed on the current confidential inventory are still considered confidential (otherwise, they would appear on the public TSCA Inventory).

Claims of confidentiality will need to be substantiated and will be subject to review every 10 years.

EPA will be required to evaluate risks for chemicals on the reset TSCA inventory, and, for the first time, will need to make affirmative decisions regarding risk for all Pre-Manufacturing Notifications (PMNs) and Significant New Use Notifications (SNUNs) submitted under the amended law. EPA will also have expanded authority to require additional health and safety data on new chemicals, new uses, and high priority chemicals already in commerce, and will prioritize the use of alternative, non-vertebrate testing methods. Also, it is critical to know that obligations under the existing TSCA law are not obviated once the Act goes into effect. Thus, if your company is required to submit under the current Chemical Data Reporting (CDR) Rule for 2016, the September 30, 2016 CDR deadline remains in effect.

If you have questions about your data obligations under the modernized TSCA law or need support regarding enhanced exposure assessments, interpretation of in vitro or modeled data, or re-assessment of toxicity evaluations for existing chemicals, our Chemical Compliance and Product Stewardship team is available to help. Please visit Gradient’s website or contact us.



For more information on Gradient’s Services, please contact:

Jessie M. Kneeland, Ph.D.
Senior Environmental Chemist

jkneeland@gradientcorp.com

Ari S. Lewis, M.S.
Principal

alewis@gradientcorp.com

Jiaru Zhang, M.P.H.
Senior Toxicologist

jzhang@gradientcorp.com

 


Gradient is an environmental and risk science consulting firm renowned for our specialties in Toxicology, Epidemiology, Risk Assessment, Product Safety, Contaminant Fate and Transport, Industrial Hygiene, Geographic Information Systems and Environmental Chemistry. We employ sound science to assist national and global clients in resolving their complex problems relating to chemicals in the environment, in the workplace, and in consumer products.

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