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EPA has released the updated TSCA Chemical Substance Inventory, with, for the first time, “active” and “inactive” designations as required by the 2016 Amendments to the Toxic Substances Control Act (TSCA).  Of the 86,228 chemicals on the Inventory, less than half (40,655 or 47%) are designated as “active.”  The updated Inventory can be accessed here.

The designations are based on reporting by chemical manufacturers, importers, and processors, which concluded on October 5, 2018, under the agency’s TSCA Inventory Notification (Active-Inactive) Rule.  “Active” substances also include those that were reported during the 2012 and 2016 Chemical Data Reporting cycles.  All substances not reported as “active” are identified as “inactive.”

While seemingly mundane, this is important stuff: chemicals that are classified as “inactive” will not be able to be manufactured or imported into the U.S. without going through EPA’s pre-manufacture notice (PMN) and review process. PMN is something to avoid, particularly after the 2016 amendments shifted the burden of proof to require that EPA now make an affirmative finding that the substance does not pose an unreasonable risk to health or the environment before allowing it on the market.

For processors (i.e., companies that use chemicals), it is imperative to confirm with suppliers that the chemicals they receive from them are designated as “active.”  Manufacture, import or use of (or placement on the market of a product containing) an “inactive” substance can incur serious penalties.  Companies that wish to start using an “inactive” substance must submit to EPA, within 90 days prior to the anticipated start of such use, a Notice of Activity (Form B) to EPA to change the Inventory designation from “inactive” to “active.”

 

During confirmation hearings before Congress last week, Acting EPA Administrator Andrew Wheeler indicated that a long-awaited EPA rule to restrict consumer and commercial uses of methylene chloride as a paint and coating remover has been delayed by the government shutdown, after being submitted to the Office of Management and Budget on December 21st.  Meanwhile, on January 14th, environmental groups and the parents of two men killed after exposure to the solvent, filed suit in the U.S. District Court for the District of Vermont seeking to compel EPA to finalize a January 2017 proposal to ban methylene chloride in most consumer and commercial paint and coating removal products.

The lawsuit is notable as the first challenge involving EPA’s new authority under 2016 amendments to the Toxic Substances Control Act (TSCA) that directs EPA to ban or restrict chemicals that present an unreasonable risk to human health or the environment.  A 2014 EPA risk assessment found that short-term exposures to high concentrations of methylene chloride-based paint and coating strippers can be fatal.  On January 19, 2017, during the last days of the Obama Administration, EPA issued a preliminary determination that the use of methylene chloride in paint and coating removal poses an unreasonable risk of injury to health.  EPA also proposed prohibitions and restrictions on the manufacture, processing, and distribution in commerce of methylene chloride for all consumer and most types of commercial paint and coating removal and on the use of methylene chloride in commercial paint and coating removal in specified sectors.

While EPA consistently has signaled its intent to finalize the rule, on the same day that the draft final rule was sent to OMB for review, the agency also sent for OMB review a preliminary draft rule entitled “Commercial Paint and Coating Removal Training, Certification and Limited Access Program.”  While no details are available, issuance of the draft “training” rule signals that at least some of the more stringent provisions applicable to commercial uses of the solvent from the January 2017 proposal may have be relaxed in the pending final rule.

In particular, the lawsuit seeks a court order directing EPA to “perform their mandatory duty under sections 6(a) and 7 of [TSCA] to address the serious and imminent threat to human health presented by paint removal products containing methylene chloride.”  Under TSCA section 6(a), EPA is directed to ban or restrict chemicals that it determines present an unreasonable risk to human health or the environment.  The plaintiffs contend that EPA has “violated the explicit command in TSCA section 6(a) that it ‘shall’ by rule restrict a chemical determined to present an unreasonable risk of injury, applying such requirements that are ‘necessary so that the chemical substance no longer presents such risk.’”  The plaintiffs also have alleged EPA failure to abide by TSCA section 7 requirements “to protect the public against ‘imminently hazardous’ chemical substances.”

The case is Vermont Public Interest Research Group et al v. Wheeler et al. (D. Vt., No. 19-00009, 1/14/19).

 

With Democrats now in control of the House, Congressional oversight of EPA’s implementation of the 2016 amendments to the Toxic Substances Control Act (TSCA) is set to ramp up.  The expected incoming chair of the House Energy & Commerce Committee, Rep. Frank Pallone (D-NJ), announced yesterday his intentions to hold a hearing early next year to address what he calls the agency’s “broad efforts to undermine” the revised TSCA.  Pallone was an early House sponsor of the bipartisan 2016 legislation that fundamentally revised TSCA and triggered a series of regulatory requirements that EPA must fulfill within a relatively aggressive timeframe.

While signed into law by President Obama, the major framework rules that govern how the agency moves forward with prioritizing, evaluating, and regulating existing and new chemicals has fallen primarily to the Trump Administration.  Like any major legislation, the “new TSCA” embodies a multitude of compromises, with differing interpretations competing to be codified in regulations.  Over the last several months, numerous controversies have arisen over how the Trump EPA is implementing the law’s new requirements, most notably with respect to how EPA defines the scope of uses (intended and reasonably foreseen) that must be evaluated in assessing the risks of a given chemical.

Rep. Pallone’s most recent statement, in fact, was issued in conjunction with the release by EPA of the first of ten draft risk assessments for existing chemicals.

“The new draft risk evaluation of [Pigment Violet 29] raises serious red flags about the Trump EPA’s commitments to scientific integrity and protecting the public health.  EPA appears to have purposely discounted known environmental hazards, numerous foreseeable uses, and all manufacturing below reporting thresholds for the Chemical Data Reporting Rule.  This is disturbing but falls in line with the Trump Administration’s ongoing attempts to weaken the updated TSCA law. We look forward to holding hearings on this draft and EPA’s broad efforts to undermine the Lautenberg Act early next year.”

The remaining draft assessments for the first wave of chemicals to be evaluated under the revised TSCA are scheduled to be issued by or soon after the new year.  Given the precedent that these initial risk assessments will establish for future chemical reviews, they are expected to be a key focus of oversight by House majority Democrats.

 

 

 

 

A new framework of fees to cover the costs of implementing the provisions of the 2016 amendments to the Toxic Substances Control Act (TSCA) will go into effect October 1st, under a final rule issued yesterday by EPA.  The fees are designed to collect $20 million annually from chemical manufacturers, importers, and processors, or about 25% of the expected agency costs of implementing the new mandates of TSCA, including chemical prioritization and risk evaluation tasks, as well as review of toxicity and exposure data submitted under an EPA test order.

These fees are intended to achieve the goals articulated by Congress by providing a sustainable source of funds for EPA to fulfill its legal obligations to conduct activities such as designating applicable substances as High- and Low-Priority, conducting risk evaluations to determine whether a chemical substance presents an unreasonable risk of injury to health or the environment, requiring testing of chemical substances and mixtures, and evaluating and reviewing new chemical submissions, as required under TSCA sections 4, 5 and 6, as well as and collecting, processing, reviewing, and providing access to and protecting information about chemical substances from
disclosure as appropriate under TSCA section 14.

Examples of some of the fees manufacturers (and sometimes processors) would pay include:

• $1.3 million for agency-initiated chemical risk evaluations;

• $2.5 million for manufacturer-requested risk evaluations for chemicals not on EPA’s 2014 TSCA Work Plan list, and $1.25 million for chemicals on the list;

• Between $9,800 and $22,800 for EPA review of toxicity, exposure, and other information companies submit in response to an EPA order, regulation, or negotiated agreement;

• $16,000 for EPA review of new chemicals (or certain new uses).

The final rule largely adopts the user fee program as proposed in February, with certain modifications to the procedures for identifying manufacturers subject to the fees, the fee calculation for chemical reviews requested by manufacturers (which are substantially higher than the fees for agency-initiated reviews), and the standard for identifying “small businesses” subject to fee reductions of approximately 80%.

The fee rule is the fourth and final of EPA’s “framework rules” for implementing the 2016 TSCA amendments.  The first three rules addressed chemical prioritization for risk assessment; the process for conducting risk evaluation; and update of the TSCA existing chemical inventory.

Further details and background information on the fee rule is available from EPA’s website:  www.epa.gov/tsca-fees.

EPA released on June 1 the “problem formulation” documents for the first 10 chemicals for which risk evaluations are being conducted under the amended Toxic Substances Control Act (TSCA).  (See:  https://www.epa.gov/newsreleases/epa-takes-three-important-steps-ensure-chemical-safety-under-lautenberg-act-proposes.)  The documents describe the chemical use and exposure scenarios that the agency expects to examine, as well as the hazards, exposures, conditions of use, and exposed populations (e.g., workers, consumers, bystanders) that will be considered as EPA conducts the risk evaluations.  Companies that manufacture or use products containing these chemicals should review the scoping documents and assess whether the use and exposure scenarios identified by EPA are accurate with respect to the products that they make or utilize in their production processes.  EPA is taking comments for 45 days upon publication in the Federal Register.

For example, the scoping documents rely in part on 2012 and 2016 Chemical Data Reporting to identify potential consumer or commercial exposures for various uses of a chemical that may be outdated or which may have been phased out.  If so, companies may wish to submit comments to EPA clarifying the nature and extent (or lack) of exposure to the chemical of interest.  Such comments could help avoid any inappropriate or misleading associations of risk that could result from the EPA evaluation.

The 10 chemicals, for which risk evaluations must be completed by December 2019, are:  Asbestos, 1-Bromopropane, Carbon Tetrachloride, 1,4-Dioxane, Cyclic Aliphatic Bromide Cluster (HBCD), Methylene Chloride, n-Methylpyrrolidone (NMP), Perchloroethylene, C.I. Pigment Violet 29, and Trichloroethylene (TCE).

 

 

As part of the continuing implementation of the 2016 amendments to the Toxic Substances Control Act (TSCA), EPA is moving rapidly to complete designation of chemicals in commerce that are considered “active.” This “Reset” effort is a first step in helping the agency pare down the thousands of chemicals listed on the TSCA Inventory and identify a subset for possible evaluation under the new chemical prioritization and risk evaluation requirements.

While seemingly mundane, this is important stuff: chemicals that are classified as “inactive” will not be able to be manufactured or imported into the U.S. without going through EPA’s pre-manufacture notice (PMN) and review process. PMN is something to avoid, particularly after the 2016 amendments shifted the burden of proof to require that EPA now make an affirmative finding that the substance does not pose an unreasonable risk to health or the environment before allowing it on the market.

On April 12, EPA released an updated public version of the TSCA Chemical Substance Inventory, which for the first time includes the “active” designations. The updated Inventory can be accessed here. (https://www.epa.gov/tsca-inventory/how-access-tsca-inventory) . The agency also released an updated list of substances reported as “active” during the current notification process pursuant to the “TSCA Inventory Notification (Active-Inactive) Rule.” (https://www.epa.gov/tsca-inventory/list-substances-reported-under-tsca-inventory-notification-active-inactive-rule). Under this program, manufacturers (including importers) were to notify EPA by February 7, 2018, of substances they currently manufacture or import, and which therefore should be deemed “active.” Fortunately, EPA also exempted from reporting, and automatically identified as “active,” substances reported under the 2012 and 2016 Chemical Data Reporting rule periods (as well as naturally occurring substances). So long as a substance is either notified to EPA by at least one company or considered exempt from reporting, then the substance is classified as “active.” At latest report, approximately 35,000 substances, or about half of the chemicals on the current TSCA Inventory, are listed as “active.”

“Processors” of chemicals – in essence, companies that use chemicals or incorporate them into their products – are now eligible to notify EPA by October 5, 2018, of any substances that have yet to be designated as “active” but which they currently use. Companies should compare their internal list of chemicals they manufacture or use with the EPA exempt list and the newly released list of already notified chemicals. If a chemical does not appear on those lists, the company should notify EPA.