TSCA Reform: Inventory Reset, Risk Prioritization and Evaluation

The landmark legislative development of 2016 was a sweeping overhaul of the Toxic Substances Control Act (TSCA). The Frank R. Lautenberg Chemical Safety for the 21st Century Act was signed into law on June 22, 2016, amending the statue of 40 years. CPMA members supported efforts to modernize the law by communicating color pigments industry concerns to their members of Congress. Regulatory implementation of the new law is well under way at the U.S. Environmental Protection Agency (EPA) and will focus on implementation of rules for prioritization and evaluation of existing chemicals.

The TSCA Inventory, which contains several hundred color pigments in commerce, will be “reset” beginning in 2017 through 2018. CPMA has advocated continuation of existing nomenclature and mixtures practices with EPA and other stakeholders. The Inventory Reset will first be populated with mandatory information submitted by companies on the 2012 and 2016 Chemical Data Reports, for quantities of substances 25,000 pounds or greater produced or sold annually. Companies producing or selling less than 25,000 pounds of a chemical substance annually must submit product information electronically to EPA. See TSCA Inventory Notification (Active-Inactive) Rule requirements.

Chemical Risk Assessments Under Canada's Chemicals Management Plan

The third phase of the Chemicals Management Plan (CMP), launched in May 2016, requires evaluation and assessment of 1,550 chemical substances, including one hundred color pigments. The Chemicals Management Plan process began 10 years ago with a list of 4,300 substances identified by the Canadian government for risk assessment.

CPMA worked with Health Canada and Environment & Climate Change Canada (the Ministries) by providing toxicological studies information for color pigments identified for assessment during Phase I and Phase II of CMP. Participation of CPMA on behalf of the color pigments industry in this process resulted in only one minor restricted use for a single color pigment out of hundreds of color pigments evaluated. For example, a May 2016 screening assessment from the Ministries found that 32 of 33 Monazo pigments, including C.I. Pigment Red 4, do not require risk management action in commerce. CPMA partnered with the Canadian Cosmetic, Toiletry and Fragrance Association (CCTFA) to provide technical information about the use of C.I. Pigment Red 4 in lipstick formulations, along with current regulations governing that color pigment in Europe and the United States.

CPMA will continue to engage Canadian Ministries in the assessment of the remaining color pigments during the period 2017-2020 by identifying and providing appropriate technical information and data for review by regulators.

North American Nanomaterials Regulations

On January 12, 2017, the U.S. Environmental Protection Agency (EPA) published a rule establishing reporting and recordkeeping requirements for certain chemical substances when manufactured or processed at the nanoscale. The rule went into effect on August 14, 2017.

Working closely with other impacted industries and the Nanotechnology Coalition, CPMA produced a significant outcome for color pigments manufacturers in North America and globally. The EPA’s acknowledgement of specific regulatory definitions for nanomaterials, as recommended by CPMA during the formal comment period, established specific boundaries for compliance by color pigments manufacturers and sellers. CPMA developed a nanomaterials compliance guidance document for its members to leverage in determining compliance requirements for their companies, and downstream customer industries.

The effort to enact nanomaterials reporting requirements in Canada has been delayed to 2018, affording CPMA and its member companies the opportunity to engage Canadian regulators during stakeholder outreach events, and provide relevant technical information to regulators and other industry stakeholders regarding color pigments manufacturing processes.