By Lynn L. Bergeson and Carla N. Hutton
On August 22, 2017, the U.S. Environmental Protection Agency (EPA) Office of Inspector General (OIG) announced that it plans to begin preliminary research to assess Chemical Data Reporting (CDR) under the Toxic Substances Control Act (TSCA). According to OIG’s Project Notification, the specific objectives for this evaluation are to determine: (1) how EPA is ensuring that companies are compliant with CDR requirements under TSCA; and (2) whether EPA is using CDR data to prioritize imported and manufactured chemicals for the purpose of identifying the potential for human health and environmental risks. The Project Notification asks Wendy Cleland-Hamnett, Acting Assistant Administrator for the Office of Chemical Safety and Pollution Prevention, and Lawrence Starfield, Acting Assistant Administrator for the Office of Enforcement and Compliance Assurance, to provide the following information:
- Policies, procedures, and guidance on how CDR data are used in the prioritization of chemicals for TSCA risk evaluations and/or other assessments;
- Policies, procedures, and guidance regarding the quality assurance/quality control of CDR data; and
- Enforcement response policy and guidance for CDR violations.
The Project Notification states that the anticipated benefits of the project are “reduced risks to human health and the environment from the monitoring and oversight of TSCA chemicals subject to the CDR rule reporting requirements.”
By Lynn L. Bergeson and Margaret R. Graham
On May 2, 2017, the U.S. Environmental Protection Agency (EPA) announced it would convene a public meeting to clarify and discuss the process of negotiated rulemaking on changes to Chemical Data Reporting (CDR) requirements for inorganic byproducts. The meeting will be held on May 9, 2017, from 9:00 a.m. to 5:00 p.m. (EDT) and on May 10, 2017, from 9:00 a.m. to 3:00 p.m. (EDT), in Washington, D.C. at the Capital Hilton, 1001 16th Street, N.W, in the General Session Room (South American AB).
On December 15, 2017, EPA published a notice in the Federal Register of its intention to establish a Negotiated Rulemaking Committee (NRC) under the Federal Advisory Committee Act (FACA) and the Negotiated Rulemaking Act. 81 Fed. Reg. 90843. The NRC will implement the amended Toxic Substances Control Act (TSCA) Section 8(a)(6) requirement that EPA “enter into a negotiated rulemaking … to develop and publish, not later than 3 years after the date of enactment … a proposed rule providing for limiting the reporting requirements under this subsection for manufacturers of any inorganic byproducts, if the byproducts, whether by the byproduct manufacturer or by any other person, are subsequently recycled, reused, or reprocessed.” EPA states that it is holding this public meeting prior to the establishment of that NRC to “exchange information and clarify a number of aspects of inorganic byproduct identification and reporting.”
Information about attending this meeting and its agenda will be posted to the NRC website. More information on the establishment of the NRC is available in our blog item EPA To Establish Negotiated Rulemaking Committee Under Amended TSCA.
On September 19, 2016, the U.S. Environmental Protection Agency (EPA) posted a notice on the Chemical Data Reporting website that it has amended the CDR regulations to extend the 2016 submission deadline from September 30, 2016, to October 31, 2016. According to the pre-publication version of the Federal Register notice for the final rulemaking, EPA received a request for an extension, citing problems with certain aspects of the electronic reporting system that impact a business’s ability to submit within the required timeframe, and agreed that additional time should be afforded. EPA clearly states, however, that the extension is a one-time extension for the 2016 reporting period only. The action does not impact the reporting timeframe for the 2020 CDR.
Because the original reporting deadline of September 30, 2016, was imminent, EPA will utilize discretion under the Administrative Procedure Act that allows it to issue a final rule if standard public review and comments are impracticable (Section 553(b)(3)(B)) and for “good cause” (Section 553(d)).
The rulemaking will be effective upon publication in the Federal Register.
By Lynn L. Bergeson and Richard E. Engler, Ph.D.
The topics from Section 8 of TSCA, regarding reporting and retention of information, included: Small Manufacturer Definition; Reporting by Processors; Inorganic Byproduct Rulemaking and Reporting; TSCA Inventory; and Nomenclature. The key points from this portion included:
- The sales thresholds for small manufacturers are likely to rise from the current level that was set in 1986;
- TSCA Inventory “reset” will require companies to report for substances manufactured or imported in the last 10 years and there will be no exemptions for polymers or low volume substances;
- EPA may impose different requirements for CDR reporting by manufacturers and processors;
- EPA must enter into negotiated rulemaking to reduce CDR reporting for recycling and reprocessing inorganic byproducts; and
- Interested parties should be aware of rulemaking on these issues as well as rules that EPA will be promulgating to implement other sections of TSCA.
The topics from Section 14 of TSCA, regarding CBI, included: Information Not Protected; Asserting CBI; Presumptive CBI; Requirements for CBI Claims; Exemptions to Protection from Disclosure; Review and Resubstantiation; Duties of Administrator; and Criminal Penalties. The key points from this portion included:
- Most CBI claims made prior to enactment of TSCA reform will not require substantiation, but claims going forward, including chemical identity for substances notified as “active” on the TSCA Inventory will require substantiation;
- EPA must review all CBI claims for chemical identity;
- CBI protection that requires substantiation will sunset after ten years; claimants may reassert and resubstantiate claims to continue protection for another ten year period;
- EPA must disclose CBI upon request from state, municipal, and tribal officials who demonstrate the need for the information and agree to protect CBI;
- EPA must also disclose CBI upon request from medical professionals if it is reasonable to believe the information is necessary to treat a patient; and
- In most cases, EPA will notify CBI claimants prior to disclosing CBI to persons that are not federal employees or federal contractors.
The panel speakers were, from B&C: Charles M. Auer, Senior Regulatory and Policy Advisor, former Director of the Office of Pollution Prevention and Toxics (OPPT), U.S. Environmental Protection Agency (EPA); Lynn L. Bergeson, Managing Partner; Richard E. Engler, Ph.D., Senior Chemist, former senior staff scientist in OPPT and leader of EPA's Green Chemistry Program; and Kathleen M. Roberts, Vice President, B&C Consortia Management, L.L.C.; and from Chemical Watch: Kelly Franklin, North America Reporter & Editor.
The fourth and final webinar in the series, “Other Provisions -- PBTs, Preemption, and Green/Sustainable Chemistry” will be presented on September 27, 2016.
Monday, September 12, 2016
8:00 a.m. Pacific Daylight Time/11:00 a.m. Eastern Daylight Time/16:00 British Summer Time
With passage by unanimous consent voice vote of the U.S. Senate of the Frank R. Lautenberg Chemical Safety for the 21st Century Act on June 7, 2016, this bill, that profoundly alters the regulation of industrial chemicals in the U.S. under TSCA, has cleared all hurdles and was signed into law by President Obama on June 22, 2016.
All chemical stakeholders doing business in the U.S., as well as foreign entities with business interests in the U.S., will need to understand the fundamental shifts in requirements, and the new concepts and approaches that are introduced by the law.
Bergeson & Campbell, P.C. has collaborated with Chemical Watch in assembling an impressive faculty of TSCA experts representing the perspectives of industry, environmental organizations, and U.S. federal and state regulatory authorities to present a series of complimentary webinars titled "'The New TSCA' -- What You Need to Know."
Webinar 3: Inventory, CDR, and CBI (Sections 8 & 14)
- Charles M. Auer, Charles Auer & Associates, LLC, former Director of the Office of Pollution Prevention and Toxics (OPPT), U.S. Environmental Protection Agency (EPA)
- Lynn L. Bergeson, Managing Partner, Bergeson & Campbell, P.C.
- Richard E. Engler, Ph.D., Senior Chemist, Bergeson & Campbell, P.C., former senior staff scientist in OPPT and leader of EPA's Green Chemistry Program
- Kelly Franklin, Chemical Watch
- Kathleen M. Roberts, Vice President, B&C® Consortia Management, L.L.C.
- Section 8 Reporting and Retention of Information
- Small Manufacturer Definition
- Reporting by Processors
- Byproduct Rulemaking and Reporting
- Toxic Substances Control Act (TSCA) Inventory
- Section 14 Confidential Business Information (CBI)
- Information Not Protected
- Asserting CBI
- Presumptive CBI
- Requirements for CBI Claims
- Exemptions to Protection from Disclosure
- Review and Resubstantiation
- Duties of Administrator
- Criminal Penalties
Additional Webinars in "The New TSCA" Series:
||Webinar 1: Overview and Summary of Major Changes: What to Expect and When to Expect It, presented June 13, 2016.
||Webinar 2: Impacts on New Chemical Programs, presented July 14, 2016.
||Webinar 4: Other Provisions -- PBTs, Preemption, Green/Sustainable Chemistry -- will be presented on September 26, 2016.