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By E. Lynn Grayson
EPA recently extended the effective date of the final reporting and recordkeeping requirements for certain chemical substances when they are manufactured or processed at the nanoscale. EPA has delayed the effective date of the January 12, 2017 final rule from May 12, 2017 to August 14, 2017.
Industry sought to repeal the rule, or at a minimum, obtain an extension of the effective until EPA adopts guidance explaining how to comply with the new two-fold requirements including: 1) companies that make, import or process a distinct or “discrete” form of a nanoscale chemical at some time in the future are to provide information to EPA (135 days before they make, import or process the chemical or within 30 days of deciding to manufacture or process the chemical); and 2) companies must comply with a one-time obligation to report information known or reasonably attainable regarding any nanoscale chemicals made or processed at any time during the past three years. Based upon the information EPA receives, the Agency could decide to require new toxicity, exposure or other data or it could decide to impose restrictions on commercial activity.
Nanomaterials—a diverse category of materials defined mainly by their small size—often exhibit unique properties that can allow for novel applications but also have the potential to negatively impact human health and the environment. Some nanomaterials: more easily penetrate biological barriers than do their bulk counterparts; exhibit toxic effects on the nervous, cardiovascular, pulmonary and reproductive systems; or have antibacterial properties that may negatively impact ecosystems.
Regulation of nanomaterial has created conflict between industry and environmental groups. The Nanomanufacturing Association suggests the rule is a de facto permitting program, while environmental groups believe the rule is long overdue and its impacts are limited by the authorities and procedures already existing under the Toxic Substances and Control Act (TSCA), the federal statute authorizing the new rule. Nanomaterials are used in a variety of commercial and industrial applications including paints, coatings, resins and a host of consumer products ranging from washing machine parts to lithium ion batteries.
A number of scientific organizations have called for the need for the kinds of information on nanomaterials EPA will now be able to collect including the National Academy of Science and the National Nanotechnology Initiative. At this time, it is unclear if the EPA draft guidance will be finalized before the effective date of the new rule.