On August 11th, 2017, USEPA published the “TSCA Inventory Notification (Active-Inactive) Requirements” (82 FR 37520) (“Active-Inactive Rule”) to require industry reporting of nonexempt chemicals manufactured, imported, or processed domestically over the past 10 years ending on June 21st, 2016.
The Frank R. Lautenberg Chemical Safety for the 21st Century Act (the “Act”) was signed by President Obama and went into effect on June 22nd, 2016. The Act amends and updates the Toxic Substances Control Act of 1976 (“TSCA”) and is the most recent environmental initiative to receive bipartisan support in both the U.S. House of Representatives and the Senate. (https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/frank-r-lautenberg-chemical-safety-21st-century-act). In accordance with TSCA Section 8(b), USEPA is required to update and publish a list of each chemical substance that is manufactured, imported, or processed in commerce on the TSCA Inventory (chemicals of concern). There are currently about 85,000 chemicals listed on the Inventory.
To strengthen the management of chemicals, the Lautenberg Act requires USEPA to issue a final rule which informs the prioritization of chemicals for risk evaluation and helps the agency to designate substances on the Inventory as “active” or “inactive” in U.S. commerce. USEPA promulgated the Active-Inactive Rule to accomplish this.
Who is affected?
The rule may affect persons who “domestically manufactured, imported, or processed a chemical substance” designated on the Inventory for “nonexempt commercial purpose during the 10-year time period, ending June 21st, 2016.” 82 FR 37521. The rule also may affect persons who “intend to domestically manufacture, import, or process” such chemical substance in the future. Id.
What are the reporting requirements?
The agency has delineated two different notification scenarios under this rule: retrospective reporting requirements and forward-looking reporting requirements. The retrospective reporting requirements apply to “chemical substances listed on the Inventory that were manufactured or processed for nonexempt commercial purposes in the U.S. over the past 10 years, ending on June 21st, 2016.” 82 FR 37523. The agency refers to this 10-year period as the “lookback period.” Alternatively, the forward-looking reporting requirements apply to “substances listed as inactive on the Inventory that are to be reintroduced into U.S. commerce for nonexempt purposes.” 82 FR 37523.
What information is to be reported?
USEPA has created two versions of a Notice of Activity (“NOA”) reporting form: the Notice of Activity Form A will be used for retrospective reporting, while the Notice of Activity Form B will be used for forward-looking reporting. USEPA will use the information received from the reporting to designate as “active” those substances on the Inventory for which the agency received notices. If the agency does not receive any notices, then that substance will be designated as “inactive.”
NOA Form A (Retrospective): Manufacturers and importers who produced a chemical substance subject to commercial activity designation for a nonexempt purpose at any time during the “lookback period” are required to complete and submit Form A. Processors have the option to voluntarily report under Form A during the retrospective reporting period, but are not required to do so. The company will be required to provide information including: the company name, official technical contact, CASRN, CA Index name, Accession No., required certification statements, and whether the company seeks to maintain an existing claim for protection against disclosure of confidential business information (“CBI”) chemical identity. See 82 FR 37541.
NOA Form B (Forward-Looking): Persons who intend to manufacturer, import, or process an inactive substance for a nonexempt purpose after the effective date of the agency listing that substance as inactive must complete and submit Form B. The company will be required to provide as the information described above for the Form A as well as the anticipated date of manufacturing or processing for a nonexempt commercial purpose. See 82 FR 37541.
Confidential Business Information (CBI): USEPA states that notices under the Active-Inactive Rule may contain two types of CBI claims: claims for protection of information other than specific chemical identity, and requests to maintain existing claims for protection of specific chemical identity. 82 FR 37527. For the former, the person claiming CBI must provide a specific certification statement describing the basis for the CBI claim, and the claim must be substantiated at the time of submission. Id. For the latter, USEPA will allow any manufacturer or processor submitting a NOA to seek to maintain an existing CBI claim for specific chemical identity, regardless of whether that person asserted the original CBI claim for the substance. Id. The agency also states that it will move an active substance from the confidential portion of the Inventory to the non-confidential portion if no NOA requests are received to maintain the existing CBI claim for the specific chemical identity of that substance. Id.
How is this information submitted?
All reports are to be submitted electronically through USEPA’s Central Data Exchange (“CDX”) system and Chemical Information Submission System (“CISS”). 82 FR 37526.
Records related to retrospective notifications must be kept for a period of 5 years beginning on the last day of the submission period, while records related to forward-looking notifications must be kept for a period of 5 years beginning on the date that the notice was submitted. See 82 FR 37543.
When is reporting due?
The final rule was published on August 11th, 2017. For retrospective reporting requirements, this publication initiates a 180-day reporting period for manufactures and importers. This means that notices are due February 7th, 2018 for manufactures and importers. This publication also contains a provision that initiates a voluntary 420-day reporting period for processors. These notices are due October 5, 2018 for processors. See 82 FR 37524.
The reporting period for forward-looking requirements is effective as soon as USEPA finalizes and publishes its active/inactive substance designations of the Inventory after June 2018. Forward-looking reporting must be submitted to USEPA not more than 90 days before the anticipated date of manufacturing, importing, or processing. See 82 FR 37524.
What to expect
Despite the Trump administration’s proposal to substantially cut funding for most USEPA programs, the agency anticipates that the proposed federal budget will actually increase funding to $65 million in FY 2018 for the TSCA Chemical Risk Review and Reduction Program. See EPA Budget in Brief, EPA-190-K-17-001 (FY 2018), p. 22. The Agency also states that it plans to begin collecting new TSCA Service fees beginning in the second quarter of FY 2018, which will help fund 53.6 Full-Time Equivalent (“FTE”) staffers that were formerly funded by annual appropriations. Id. at 67. Thus, while generally the expectation is a significant pull-back of USEPA oversight or activity in nearly all other regulatory areas under this administration, we may in fact see an increased focus by USEPA in the area of toxic chemical review and regulation.