REGULATORY ALERT: TSCA REFORM AND THE IMPACT ON THE REVIEW OF EXISTING CHEMICALS

6 September, 2016

What’s Happening?

There are numerous regulatory changes coming with regards to legislation under the Toxic Substances Control Act.  Since the enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act, these changes are being implemented at a rapid pace.  For example, under new TSCA, the EPA is now required to review the risks that chemicals in active commerce may pose.  Prior to the enactment of new TSCA, most chemicals in commerce were “grandfathered-in” and no review of risk was performed.  Now, EPA is required to not only review existing chemicals but the regulation puts very aggressive deadlines in place.

How Could it Impact Me?

EPA must first identify what chemical substances are active in commerce.  Of the estimated 84,000 chemical substances listed on the TSCA Inventory, there is currently no way of knowing which of these chemicals are still in commerce.  It is anticipated that by December, 2017, the EPA will have received information from manufacturers and processors regarding chemical substances that are active in commerce.  

Once active chemical substances are identified, the EPA will prioritize these chemicals as either high priority or low priority.  High priority chemicals are substances which may cause unreasonable risk as determined by the EPA.  High priority chemicals will undergo a full risk assessment and if the chemical is found to cause unreasonable risk, the agency must to one of the following:

  • Ban the chemical
  • Phase out the chemical
  • Impose restrictions that will ensure that the chemical substance no longer presents an unreasonable risk

The first chemicals to be evaluated will come from the existing Work Plan Chemicals.  The EPA used a prioritization process to identify 83 chemicals for further assessment and published the initial list in 2012.  By December, 2016, the Agency must designate at least 10 chemicals for risk evaluation from its list of Work Plan chemicals.  By early 2017, the EPA must publish the scope of the risk evaluations.

Within 3 ½ years of enactment of new TSCA, the EPA must be conducting risk evaluations on 20 high priority chemicals and at least 10 of these chemicals must come from the Work Plan Chemical list.  Within this same time frame, the EPA must also designate at least 20 low priority chemicals.

The new law allows industry to nominate chemicals for risk evaluations but the number of industry-nominated high-priority chemicals cannot exceed 50% of the number of chemicals assessed by the EPA.  

EPA has a deadline of 3 years for all risk evaluations undertaken and this may be extended for 6 months.  Deadlines for the assessment of work plan chemicals cannot be extended unless the EPA can demonstrate that additional information is needed.

Prior to the enactment of new TSCA, there were no deadlines established for EPA’s review of existing chemical substances.  New TSCA establishes strict deadlines for the EPA to complete chemical assessments.

Recently, the EPA held public meetings to obtain input from stakeholders on the development of procedures for both risk evaluation and chemical prioritization for risk evaluation.  Information obtained during these meetings is being considered in EPA’s development of proposed rulemaking as required under TSCA.

Contact Us:

Critical Path Services can help you to interpret the changes implemented through the new law and assist you in positioning your company to meet these new challenges.

Critical Path can also provide representatives of your company with a free consultation to talk you through the major changes enacted by the new law and how these changes could affect your business.

Elizabeth Dederick, Ph.D. Vice President, Industrial Chemicals and Biocides
+1 610 558 3001 Ext. 102 +1 610 558 6025 send mail