EPA Issues Nanomaterials Reporting Rule

The information is to include the specific chemical identity, production volume, methods of manufacture and processing, exposure and release information, and existing information concerning environmental and health effects, "insofar as known to or reasonably ascertainable by the person making the report," it states.

EPA issued a final regulation Jan. 11 requiring one-time reporting and recordkeeping of exposure and health and safety information on chemical substances at the nanoscale level. The information is to include the specific chemical identity, production volume, methods of manufacture and processing, exposure and release information, and existing information concerning environmental and health effects, "insofar as known to or reasonably ascertainable by the person making the report," it states.

These are chemical substances that have structures with dimensions at the nanoscale -- approximately 1-100 nanometers (nm); a human hair is approximately 80,000 to 100,000 nanometers wide.

The agency took the action pursuant to its authority under section 8(a) of the Toxic Substances Control Act, known as TSCA, as part of its efforts to ensure a more comprehensive understanding of nanoscale materials in commerce.

EPA said the information collection "is not intended to conclude that nanoscale materials will to cause harm to human health or the environment. Rather, EPA will use the information gathered to determine if any further action under TSCA, including additional information collection, is needed."

EPA proposed and then took comments on the rule. Entities that manufacture or process a reportable chemical substance during the three years prior to the final effective date of the rule must report to EPA within a year of the rule's publication.

Jay West, senior director of chemical products and technology at the American Chemistry Council, said EPA made "positive" changes to its final nanomaterials reporting rule but not all concerns were addressed sufficiently. The council is compiling a list of topics that it believes require additional explanation and will send that the agency, he said.

Likewise, Richard Denison, Ph.D., a lead senior scientist with the Environmental Defense Fund, wrote that the rule does not include some reporting requirements that EDF recommended, including that chemical substances "formed at the nanoscale as part of a film on a surface" are exempted from reporting.

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