EPA Announces Tiered Data Reporting Rule, ACA Submits Comments

Last month, EPA published in the Federal Register its intention to develop a Tiered Data Reporting (TDR)  rule requiring manufacturers — and sometimes processors —  to report targeted information to the agency informing on three stages (or tiers) of TSCA evaluations: 1) pre-prioritization; 2) prioritization; and 3) risk evaluation/risk mitigation. The TDR rule would require submission of standardized data sets that would inform EPA activities at each tier. According to EPA, the TDR rule could assist companies with planning for data submissions, while enhancing overall quality of data available to EPA.

While only manufacturers would be required to report in Tier 1 (pre-prioritization) and Tier 2 (prioritization), EPA suggests requiring processors and manufacturers report in Tier 3 (risk evaluation / risk mitigation). EPA seemingly suggests voluntary processor reporting at Tier 2 with mandatory processor reporting at Tier 3.

In its announcement, which was followed by a public webinar, EPA indicated that it would reduce reporting obligations under the Chemical Data Reporting rule (CDR), since the TDR will yield detailed data. EPA may limit CDR so it has enough information to identify chemicals as candidates for pre-prioritization, including some exposure information. The comment deadline for this preliminary notification was Aug. 16.

EPA’s notice provides general descriptions, but no details on a proposed rule, yet to be published. During pre-prioritization, data collection may focus on additional exposure information and conditions of use. Once a chemical is selected for prioritization, manufacturers may report within three (3) months, since EPA has 9-12 months to complete prioritization. During prioritization, EPA may require additional information about uses including discontinued uses, products and articles, industry sectors, hazard and toxicity, exposure monitoring, SDS, etc.

EPA suggests manufacturers and processors report a set of information during risk evaluation and later update that same set of information during risk mitigation, with any changed information or additional details. Information may include risk mitigation strategies, essential uses, uses that can be phased out, chemical alternatives, etc.

ACA Comments

On Aug. 16, ACA filed joint comments as a member of the Ad Hoc Downstream Users Coalition, along with other association members… Since EPA has only provided a broad conceptual framework of their approach to a TDR, the comments were general, but reflect the concerns and recommendations that the Coalition would like EPA to consider. The coalition’s comments are a continuation of long-standing advocacy to provide industry with a clear statement of EPA’s data needs and an adequate time frame for collection of data.

Specifically, the coalition urged EPA to acknowledge the unique differences between chemical manufacturers and importers of articles and chemical mixtures. Notably, importers of chemical mixtures and articles do not have access to same hazard and exposure information as bulk and specialty chemical manufacturers. As this rulemaking progresses, ACA and the coalition asked EPA to heed to all the previous information that importers of chemical mixtures and articles have submitted and to assign data submission responsibilities to those who are most likely to have the relevant information. Downstream importers of chemical mixtures and articles are unlikely to have hazard and exposure data but may be able to provide information on the presence of a chemical in the manufacturing process.

As such, the coalition’s comments focused on the following points:

• The conceptual model presented by EPA lacks the specificity necessary to provide comments on implementation;
• The insufficient nature of a two-week public comment period given the opportunity at stake to inform and shape the proposed rule, which is likely to have a significant impact on the regulated community;
• That there should be reasonable exemptions built into the data call-in process so that chemical users, importers of articles and mixtures and other traditionally exempt categories are not expected to review files for the types of data they are unlikely to have;
• That EPA should conduct data call-ins on a reasonable and defined schedule to provide sufficient timing to chemical users and importers of articles and mixtures to generate data;
• Data call-ins should be tiered based on the stage in the process for which the call-in is made;
• Information requests should be directed to those most likely to have the desired information and exempt those unlikely to have useful data;
• Data quality parameters should guide the submission of information and be explained in the proposed rule or in accompanying guidance; and
• That listings should clearly communicate that it is not a determination of risk.

The coalition comments also underscored that supply-chain pathways may also cross borders multiple times in some industries, which can be a complicating factor. In sum, the comments stressed that if this rulemaking moves forward, it must reflect the reality of what data is available from chemical manufacturers, processors, chemical users, and importers of articles and service chemicals.

Contact ACA’s Riaz Zaman for more information.

The post EPA Announces Tiered Data Reporting Rule, ACA Submits Comments appeared first on American Coatings Association.

from American Coatings Association https://www.paint.org/epa-tdr/
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