On August 11, 2017, the Environmental Protection Agency (EPA) published the TSCA Inventory Notification (Active/Inactive) Requirements final rule. Under this rule, pursuant with TSCA Section 8(b), EPA will require electronic notification of nonexempt chemical substances on the TSCA Inventory manufactured (including imported) during the 10-year time period ending June 21, 2016. This rule also includes a future activity reporting for nonexempt chemical substances listed after June 21, 2016. Notifications can be made by both manufacturers (importers) as well as processors. Chemical substances added to the Inventory on or after June 22, 2016 will be designated as active, by operation of this rule. Manufacturers must report to EPA not later than 180 days after the final rule is published in the Federal Register. Processors may report not later than 420 days after the final rule is published.
Exponent has significant expertise helping clients with registering and navigating EPA’s Central Data Exchange for electronic submissions, chemical inventory evaluations and reporting, and Bona Fide Intent to Manufacture (BFI) submissions to search the confidential TSCA inventory.
How will EPA use the Retrospective Reporting?
EPA will use the chemical identity information obtained from this retrospective reporting to designate as active those substances on the Inventory for which notices were received. If no notice is received during this retrospective reporting for a substance subject to designation on the Inventory, then that substance will be designated as inactive. The information to be reported includes chemical identity and the date when manufacturing or processing is anticipated to resume. Upon receipt of such notices, EPA will change the designation on the Inventory from inactive to active.
How do I Report?
All reports will be made electronically through EPA’s Central Data Exchange (CDX) system. EPA is establishing the procedures regarding the manner in which such retrospective and forward looking activity notifications must be submitted, the details of the notification requirements, exemptions from such requirements, and procedures for handling claims of confidentiality. The Notice of Activity Form A (NOA-A) will be used for retrospective reporting, and the Notice of Activity Form B (NOA-B) will be used for forward-looking reporting.
When Can I Report? / How Long to Do I Have to Report?
For retrospective reporting, manufacturers must report to EPA not later than 180 days after the final rule is published in the Federal Register. The final rule went into effect on the date of publication on August 11, 2017 - therefore the reporting period has begun. Processors may report not later than 420 days after the final rule is published, this allows processors time to review any interim list of active substances.
For forward -looking reporting, TSCA section 8(b)(5)(B) further establishes a forward-looking reporting requirement that goes into effect as soon as EPA designates inactive substances after June 2018 (publication of the active/inactive substance designation of the TSCA Inventory). The forward-looking reporting requirements apply to substances listed as inactive that are to be reintroduced into U.S. commerce for nonexempt purposes. Forward-looking notices must be submitted 90 days prior to the anticipated date for resuming manufacturing or processing.
What Chemical Substances will be Exempt?
Exempt chemical substances also include TSCA listed substances reported to EPA in 2012, 2016 Chemical Data Reporting (CDR), as well as chemicals with a processed Notice of Commencement (NOC) during the 10 year reporting period for both public and confidential portions of the Inventory. Chemical substances reported to EPA in the 2012 and 2016 will be published on an interim list of active substances and will be designated as active substances, by operation of this rule, and they are exempted from retrospective notification requirements under this rule. The interim list will be available on the TSCA Inventory web page.
Chemical substances that were added to the Inventory during the ten-year time period ending on June 21, 2016, pursuant to a NOC under 40 CFR 720.102 received by the Agency between June 21, 2006 and June 21, 2016, will be designated as active substances, by operation of this rule, and they are exempted from retrospective notification requirements under this rule. Therefore, a processed NOC provides equivalent notice that the substance was manufactured or processed during the lookback period. This also applies if the manufacturer has evidence in the form of a CDX receipt, documenting EPA’s receipt of an NOA Form A from another manufacturer.
Substantiation of Confidential Business Information (CBI)
Persons who manufactured or processed a chemical substance on the confidential portion of the Inventory, that was added to the Inventory prior to June 22, 2016, should recognize that they must submit an NOA Form A to EPA if they wish to indicate that they ‘‘seek to maintain an existing claim for protection against disclosure of the specific chemical identity of the substance as confidential.” Substantiation of CBI information is necessary for all compounds; EPA is required, by statute, to move from the confidential to the public portion of the Inventory any active chemical substance for which no request is received to maintain an existing CBI claim for chemical identity.
Records relevant to retrospective notification must be retained for a period of 5 years beginning on the last day of the submission period. Records relevant to forward-looking notification must be retained for a period of 5 years beginning on the day that the notice was submitted
How Exponent Can Help
Exponent is a multi-disciplinary engineering and scientific consulting firm that brings together more than 90 different disciplines to solve important engineering, science, regulatory, and business issues facing our clients. We have significant expertise and accomplishments in helping clients with registering and navigating EPA’s electronic submissions, chemical inventory evaluations and reporting, and Bona Fide Intent to Manufacture (BFI) submissions of the confidential inventory.
Our regulatory and health consultants can prepare exposure estimates based on the use pattern and evaluate existing data on environmental and human health effects and provide advice concerning acquisition of additional data. We have significant expertise in new chemical submissions as well as chemical exposure assessments, and are prepared to assist clients in the development of relative risk ranking systems for portfolios of chemicals that incorporate both tailored exposure and hazard assessments.