Compliance: CDR Rule Shows Room for Improvement

An audit recommends implementing policies for conducting data quality checks

By Lynn L. Bergeson

This summer, the U.S. Environmental Protection Agency’s Office of Inspector General (OIG) issued a report titled “EPA’s Chemical Data Reporting Rule Largely Implemented as Intended, but Opportunities for Improvement Exist.” The OIG conducted an audit to determine how the EPA is ensuring companies are compliant with the Chemical Data Reporting (CDR) rule under the Toxic Substances Control Act (TSCA), and whether the EPA uses CDR data to prioritize chemicals for the purpose of identifying their potential risks to human health and the environment. The OIG found that implementing policies for data quality checks will help tailor the information reported to meet the EPA’s needs. This column discusses the report.

Accessing information from the EPA’s database proved difficult.

Background

Under the CDR rule, the EPA collects information about the types, quantities and uses of chemical substances produced domestically and imported into the United States. The OIG states that the EPA uses this information, which manufacturers and importers must submit every four years, to screen and prioritize chemicals for the purpose of identifying potential human health risks and environmental effects as outlined in the TSCA Work Plan for Chemical Assessments.

The Frank R. Lautenberg Chemical Safety for the 21st Century Act, enacted in 2016, amended the TSCA, requiring the EPA to identify high- and low-priority chemicals and evaluate high-priority chemicals against a new risk-based safety standard. By December 2019, the EPA must complete risk evaluations for the first ten high-priority chemicals, ramp up the risk evaluation process so that 20 high-priority chemicals are under evaluation at all times, and identify 20 low-priority chemicals that won’t undergo further evaluation.

The chemical risk evaluation process consists of three stages: prioritization, risk evaluation and risk management. In 2016, the EPA announced the first ten high-priority chemicals identified to undergo risk evaluation. The OIG states that the EPA continues to consider strategies for future use of CDR data for pre-prioritization and risk assessment. Late last year, the EPA held a public meeting to focus on possible approaches for identifying and prioritizing candidate chemicals for the TSCA risk assessment process. The EPA requested comment on approaches that could guide the identification process.

OIG’s Findings

According to the OIG, the EPA, as required by the TSCA, uses CDR data to help assess the risks of chemicals in U.S. commerce. The OIG determined the EPA is implementing the risk evaluation process as outlined in its TSCA Work Plan. The EPA relies on tools such as on-site inspections to monitor companies’ compliance with the CDR rule, and takes enforcement action when violations are identified. While the agency conducts data quality checks of the chemical information submitted by companies, it lacks documented policies and procedures that specify how to select and conduct these checks. The OIG noted that policies and procedures would help the EPA implement future data quality checks that meet its information needs and help prevent the loss of institutional knowledge during periods of staff turnover.

The OIG also pointed out that accessing information from the EPA’s database proved difficult. To help users better navigate the data, the EPA provided Microsoft Excel files and a data dictionary. These improvements intend to enhance the public’s ability to obtain information about chemicals in U.S. commerce.

OIG Recommendation

The OIG recommended the Office of Chemical Safety and Pollution Prevention (OCSPP) develop a policy and procedures for checking the quality of CDR data submitted by companies. According to the OIG, OCSPP concurred and provided an acceptable corrective action with a milestone date of October 25, 2018. The OIG states the proposed corrective action, when completed, will meet the intent of its recommendation.

Discussion

The OIG report produced few surprises; it’s well known that CDR data are difficult for stakeholders to access and extract. As discussed in the OIG report, the EPA took steps to improve access and we are hopeful these measures prove successful. The OIG recommendation that the EPA develop and implement an internal policy and procedures for staff in conducting quality assurance and control checks of CDR data submissions is useful; it will help to improve the quality and fidelity of CDR data when used by the EPA and stakeholders.


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LYNN L. BERGESON is Chemical Processing's Regulatory Editor. You can e-mail her at lbergeson@putman.net

Lynn is managing director of Bergeson & Campbell, P.C., a Washington, D.C.-based law firm that concentrates on conventional, biobased, and nanoscale chemical industry issues. She served as chair of the American Bar Association Section of Environment, Energy, and Resources (2005-2006). The views expressed herein are solely those of the author. This column is not intended to provide, nor should be construed as, legal advice.

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