August 19, 2016

EPA Seeking Public Input on Procedural Rules Implementing 2016 TSCA Amendments

Arnold & Porter Advisory

Within days of President Obama signing into law wholesale changes to the Toxic Substances Control Act (TSCA),1 the nation's central statute regulating chemical substances, the US Environmental Protection Agency (EPA or Agency) issued its initial plans for the next 12 months for implementing the amendments, and the Agency held a series of public meetings to solicit public comment on near-term actions EPA must complete within the coming year. The following provides further details.

EPA's TSCA Amendments First-Year Implementation Plan

On June 29, one week after the amendments were enacted, EPA published its First Year Implementation Plan for operationalizing the law's new requirements. The Implementation Plan articulates EPA's vision for how it intends to undertake and complete tasks assigned by Congress which must be accomplished within the first year following enactment of the amendments on June 22. The Agency's near-term objectives are divided into four categories (drawn from the most immediate deadlines in the revised Act): (1) immediate actions (including updates to efforts that were in progress even before the amendments took effect); (2) the so-called Framework Actions (various rulemakings to establish procedures to govern implementation of important new provisions of TSCA); (3) other mandatory actions to be completed within the next 12 months; and (4) longer-term actions that are required to be completed within two or more years, but for which work may begin sooner. The complete Implementation Plan can be found here (last visited August 19, 2016).

Initial Rulemakings (Framework Actions)

The Framework Actions require EPA to develop and issue new rules which will establish Agency procedures for certain cornerstone features of the law. These new rules must be promulgated by the end of June 2017. The Framework Actions will encompass: (i) the new Section 6 chemical prioritization process; (ii) the risk evaluation procedures and methods, also under amended Section 6; (iii) EPA's rulemaking specifying procedures for identifying and designating those substances listed on the current TSCA Inventory of chemical substances which should be considered commercially "active" or "inactive"; and (iv) EPA's new and expanded fees prerogative, whereby Congress granted EPA broad discretion to set and collect fees from chemical manufacturers and importers who submit information and data requiring Agency review and response (including claims for confidential treatment of trade-secret information).

Prioritization. EPA is expected to use the risk prioritization process it must establish through notice-and-comment rulemaking to identify and select chemical substances for review to determine the queue for the Agency's new risk evaluation process. Chemicals are to be designated as "high priority" substances when EPA determines they "may present an unreasonable risk" to human health or the environment. Substances which do not meet this standard are to be classified as "low priority" for further action. High priority substances must undergo risk evaluations subject to deadlines specified in the amended statute; EPA is not required to undertake any additional action on "low priority" chemicals. (The designation of a chemical substance as low priority is subject to change if the Agency receives new information, and is subject to judicial review if challenged.)

Risk Evaluation. The Agency's new risk evaluation process will be inaugurated before EPA can even complete its work drafting the two central framework rulemakings for prioritizing and evaluating substances because the Agency must identify by mid-December an initial list of 10 Work Plan chemicals for which EPA will initiate risk evaluations. The evaluation process for these initial 10 substances, and any subsequent High Priority substances, must focus solely on risk (i.e., EPA is not to consider costs or other economic considerations), including risks to vulnerable populations (specifically subgroups that may be uniquely susceptible – such as children and pregnant women). If EPA determines a substance "presents an unreasonable risk" to health or the environment, the Agency must undertake a rulemaking to reduce risks to a reasonable level. When a risk evaluation results in a determination that a substance will present an unreasonable risk, the Agency must issue a regulation to manage those risks. The EPA's decisions will be expected to reflect the "best available" science and the "weight of the evidence."

When completed, these first two framework rulemakings will establish the Agency's mechanisms and procedures for prioritizing substances for risk evaluation reviews and articulate the opportunities for public engagement when EPA is prioritizing specific candidate substances for review. EPA is required under TSCA to have at least 20 ongoing risk evaluations by the end of 2019.

Inventory. Among the new rules EPA must complete within one year is a regulation establishing new procedures whereby manufacturers, importers, and processors must provide information enabling EPA to update the TSCA Inventory to more accurately depict which substances are currently being commercially manufactured, imported, and processed in the US. Thus, substances currently listed will be designated "active" or "inactive." EPA is to retain the chemical nomenclature conventions it followed when the initial Inventory was created. This rulemaking should not be overlooked as the TSCA Inventory establishes the dividing line between "existing" and "new" chemicals. New substances may not be manufactured or imported to the US with prior notice to EPA.

Fees. The amendments to Section 26 of TSCA authorize EPA to collect new and enhanced fees from chemical manufacturers and importers to offset the EPA's costs relating to the implementation of TSCA. One portion of these fees will very likely be generated from new fees that may be imposed on manufacturers who submit premanufacture notifications and persons who submit significant new use notices. Submitters of test data in response to a Section 4 Rule or Order also may be required to support the Agency's cost of data review. Most certainly, a manufacturer who specifically requests EPA to undertake a risk evaluation for a substance that is already on the Work Plan will be expected to support 50% of the cost of the evaluation and 100% of the cost of a manufacturer-requested risk evaluation if the substance is not on the Work Plan already.

EPA is pledging to finalize all of the framework rules by June 2017.

EPA is Soliciting Public Input on Framework Actions

EPA held a series of public meetings during the week of August 8, 2016, to solicit and receive input about the Framework Actions from the general public (inclusive of chemical manufacturers, environmental groups, and other stakeholders). The first two days of meetings focused on the risk evaluation and chemical prioritization process rulemakings. EPA also planned (as the amended statute encourages EPA to do) to hold private meetings with representatives of the regulated communities that are most likely to incur new or increased fees. Those meetings were to address potential fees and the fee-setting process. By week's end, EPA decided to open up the fees meetings to the public, presumably after receiving inquiries from other stakeholders.

These initial public meetings were held during the dog-days of summer in Washington, DC – a period during which it's hard to find someone at their desk for a full work week. Online participation was enabled and Agency officials dutifully began each meeting by giving a short presentation on the major requirements of the amendments and the aspects of the revisions to the Act that will be addressed by the Framework Rulemakings. EPA treated the meetings more as "listening sessions" during which the Agency provided little insight about its intentions and strategies. The presentations given by EPA at each of these meetings can be found here (last visited August 19, 2016). Curiously, no public meeting was held to discuss the potentially very important Inventory updating exercise.

Entities that are most likely to be affected by the changes to TSCA and wish to have an early say in the pre-proposal phase to the Framework Rulemakings should take advantage of the Agency's intention to consider not only the oral comments received during the recent public meetings but also any written comments received in the near term period before proposals can be issued. EPA is accepting written comments until August 24, 2016 (although there is no statutory deadline compelling this cut-off date). A public docket was opened in the context of the meeting and the invitation to submit written comment. Such comments may be submitted electronically here. The Agency intends to publish proposed rules for each of the Framework Actions by December 2016.

Arnold & Porter has been and will continue to be an active participant in EPA's public meetings and related events addressing the TSCA Amendments. For example, the firm recently hosted a June meeting of the ABA's Committee on Pesticides, Chemical Regulation, and Right-to-Know law at which EPA leaders discussed their Implementation Plan, and environmental group leaders, trade association representatives, and private practitioners came together to learn about and discuss the final version of the amendments as well as the many new challenges facing EPA.

  1. An in-depth evaluation of the legislation, including the ways it can affect businesses and the steps that can be taken now to avoid significant disruptions, is available here.

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