EPA evaluations for TSCA chemicals

Responding is Roger Marks, technical content writer, Lion Technology Inc., Sparta, NJ.

The major Toxic Substances Control Act reform law, the Frank R. Lautenberg Chemical Safety for the 21st Century Act, requires EPA to evaluate the risks of all chemical substances listed on the TSCA Inventory.

The TSCA Inventory lists all chemicals manufactured, processed or imported in the United States. First published in 1979, the inventory has grown from 62,000 chemicals to more than 85,000 today.

To evaluate the risks of all of these chemicals, EPA must set priorities.

Active/inactive designations

Before it could determine which chemicals to evaluate first for risk, EPA had to figure out which chemicals on the TSCA Inventory were still being manufactured or imported in the United States. To do this, the agency required chemical industry stakeholders to submit a one-time report naming all chemicals manufactured or imported in the past decade (from June 21, 2006, to June 21, 2016).

This past February, EPA revealed the results of the one-time report: Of the 86,228 chemicals on the TSCA Inventory, 40,665 (about 47%) were active in commerce.

TSCA work-plan chemicals

EPA got a head start on its risk review process in 2012, when the agency started a work plan that identified 90 chemicals as candidates for risk evaluation.

The work plan was updated in 2014 and, in 2016, EPA selected the first 10 chemicals for risk evaluation from that plan. The list includes methylene chloride, trichloroethylene and asbestos.

High-priority vs. low-priority chemicals

To move forward with the risk evaluation process, EPA will designate certain chemicals as “high priority” and others as “low priority.”

High-priority chemicals are those that EPA believes may present an unreasonable risk of injury to health or the environment under the conditions of use. A chemical’s “conditions of use” are the circumstances under which a chemical is manufactured, processed, distributed, used or disposed of.

Low-priority chemicals are those for which EPA believes a risk evaluation is not warranted at this time. EPA announced its proposal of the first 20 low-priority chemicals on Aug. 13.

Once EPA proposes a designation of high or low priority for a chemical, the proposed designation is subject to a 90-day public comment period. After the public comments are reviewed, EPA makes a final priority designation. If a chemical is designated as a high priority, a risk evaluation begins immediately.

If EPA’s risk evaluation identifies unreasonable risks posed by a chemical, EPA must address those risks with regulation.

This past March, EPA proposed its first list of 20 high-priority and 20 low-priority candidates.

Each time EPA completes a risk evaluation for a high-priority chemical, the agency must replace the chemical on the list and begin the process for a new chemical.

Manufacturer’s requests

In addition to the chemicals EPA selects for risk evaluation, TSCA allows manufacturers to request that the agency conduct a risk evaluation on a specific chemical. Manufacturers can request a risk review through EPA’s Central Data Exchange, or CDX portal. After a public notice and comment period, EPA will grant or deny the manufacturer’s request. Manufacturer-requested risk evaluations will be conducted in the same manner as all others.

To keep up with EPA’s ongoing chemical risk evaluation process, visit EPA’s dedicated Current Chemical Risk Management Activities website at sh-m.ag/2kGw2p9.