TSCA

ETS AND THE TOXIC SUBSTANCES CONTROL ACT (TSCA)

ETS had a role to play in the bipartisan efforts to heavily amend - - reform - - TSCA. During 2014 and 2015, Stuart Cohen interacted with Members of the House of Representatives and their staff on risk assessment science, and he coauthored comments on the draft Senate and House bills with other members of the Society of Environmental Toxicology and Chemistry - North America (SETAC-NA). Dr. Cohen did this work in the context of his role as the Chair of the TSCA Reform Dialog Group of SETAC-NA (see below).

A brief summary of key amendments is followed by a description of our relevant capabilities.

TSCA Reform - - A New Day Dawns for Regulation of Chemicals in Commerce

TSCA was passed in 1976. It was designed to assess and control risky chemicals in commerce, and those proposed for entry into commerce, that are not adequately regulated under other federal environmental statutes. The general consensus is that it has worked reasonably well for new substances (premanufacture notification), it presents a rather cumbersome path to testing, and there are too many statutory obstacles to regulation of existing chemicals. There has been bipartisan agreement that a stronger, better TSCA is needed. Thus the US Congress and the President passed and signed into law on June 22nd the Frank R. Lautenberg Chemical Safety for the 21st Century Act (PL 114-182).

The Lautenberg Act strengthens the program to regulate existing chemicals, pursuant to §6 of TSCA. It sets deadlines for the EPA to conduct a risk assessment and develop a risk management approach once a chemical has been designated for assessment. Amended §5 - - the premanufacture notification provision - - now requires the EPA to make an affirmative finding for each new chemical or significant new use of a chemical that it either: presents an unreasonable risk; doesn't present an unreasonable risk; or more test data are required to support a conclusion about risk. Implementation of amended §5 has broad implications: the Environmental Defense Fund estimates that 1,000 or more new chemicals enter US commerce each year.

Following are some highlights of the new provisions in TSCA.

  • Priority setting for all chemicals, followed by safety reviews. The EPA is required to have 10 priority chemicals in the risk evaluation pipeline within 180 days of enactment. The EPA recently designated trichloroethylene (TCE), methylene chloride, and N-methylpyrrolidone under amended §6.
  • Expedited assessment and control for PBT chemicals (persistent, bioaccumulative, and toxic).
  • Improves the ability of EPA to require testing under §4(a)(2). Tiered testing is required, including exposure testing. Testing to set priorities is allowed.
  • Alternative testing methods strategy: the EPA must publish the strategy to reduce vertebrate testing within two years of enactment (§4(h)).
  • "No unreasonable risk of harm to human health or the environment..."
  • Preemption of state actions occurs if the EPA takes action (a real problem for California and other states).
  • Better access to confidential business information by state and medical personnel.
  • The EPA's safety determination would be admissible in court in toxic torts cases. This may be unpopular with some toxic torts attorneys.
  • New Chemicals/Significant New Uses: The EPA must find that the NC/SNU:
    • Presents an unreasonable risk
    • Does not likely pose an unreasonable risk
    • Information is insufficient or may present an unreasonable risk pending more information or substantial production and significant environmental or human exposure.

 

These new statutory requirements for evaluating Premanufacture Notice (PMN) submissions have implications for PMN submitters and the support we can provide to those firms (see below under "EPA Provides Environmental and Risk Assessment Support for Chemicals Regulated under TSCA").

ETS Involvement with TSCA Reform

Dr. Cohen is Chair of the TSCA Reform Dialog Group of SETAC-NA (the Society of Environmental Toxicology and Chemistry – North America). In this capacity, he was heavily involved with the following SETAC initiatives relevant to TSCA reform:

  • Conducted a seminar on risk assessment science for House of Representatives staff involved with TSCA reform;
  • Participated in a round table discussion, joint with the Society of Toxicology, for Members of the House and their staff on risk assessment; and
  • Submitted comments to the House and the Senate on draft legislation.

 

The TSCA Reform Dialog Group is part of the Public Outreach Committee of SETAC-NA. Dr. Cohen is chair of the Dialog Group, and co-chair of the Committee. SETAC-NA submitted comments to the House Energy and Commerce Committee‘s Subcommittee on Environment and the Economy. The comments were written by the Dialog Group, and they were limited to three topics addressed in two issue papers that were attached - - data quality, weight of evidence, and hazard vs risk - - plus "unreasonable risk." Comments were also provided to the Senate.

The link to the comment letter to the House is given above. Please contact us if you would like one or both of the issue papers, “The Role of the Weight of Evidence in Environmental Hazard Assessment” and "Ecological Risk Assessment of Chemicals: An Integration of Hazard and Exposure".

State Regulation in Lieu of TSCA

Previously, several states considered implementation of TSCA-type regulatory actions, given the lack of strong action and regulatory reform at the federal level.

Environmental activists and the chemical industry agreed that TSCA needs to be reformed. But until it happened, many states stepped up to fill the breach, as they see it.

  • Maryland’s General Assembly and then Governor O’Malley approved HB0099, which bans children’s products treated with the flame retardant tris(2-chloroethyl) phosphate. HB0099 became effective October 1, 2013.
  • Hawaii legislators introduced SB 383/384 (a ban on containers used by young children that contain bisphenol A (BPA) or phthalates) on January 18, 2013. The bill died in the 2013 session and was carried over to the 2014 Regular Session. The bill was not enacted and the 2014 session adjourned.
  • California is moving on more than one front. It recently proposed a standard, Technical Bulletin 117-2013, that eliminates an open flame test for foam used with furniture - - instead, relying on a cigarette smolder test - - which decreases the need for flame retardants. The state legislature is also considering reducing the use of flame retardants in building insulation. California Senate Bill 1019 requires a manufacturer to indicate whether or not products (covered by TB 117-2013) contain added flame retardant chemicals by inclusion of a specific statement on the label.
  • New Jersey, Maine, and New York are also considering action on BPA.

 

ETS Provides Environmental Fate and Risk Assessment Support for Chemicals Regulated under TSCA

As described above, the EPA must now make a definitive declaration about potential unreasonable risks for every PMN submission. Yet the 90 day ticking clock (extendable to 180 days) is still a constraint placed on the EPA. Thus it seems likely that, under time pressure, EPA staff will tend to make very conservative assumptions that result in findings of unreasonable risk when data are lacking. We can help companies avoid this scenario with a three step process, as follows:

TSCA Flowchart

Some of the models we would use in the first step are listed under "Toxic Substances Control Act Compliance: How ETS Can Help" section on the "TSCA Compliance Support" tab/page .

PBT Chemicals. "Bright line" (cutoff) criteria have been established: as part of the U.S. EPA's TSCA programs for new chemicals (section 5) and within the TSCA PBT profiler; under the Canada Environmental Protection Act; within the United Nations Environmental Program (UNEP; Stockholm Convention); and as part of the European Union's overall chemical regulation program, REACH. Increasingly, scientists realize that bright line/cutoff PBT criteria should be replaced by a more integrated approach that better predicts persistent environmental risks. However, until this happens, chemical substances often face the possibility of severe regulation if any or all of the cutoff values are exceeded.

Nanomaterials. Nonmaterials or nanoparticles are often defined as substances that have a size of approximately 1 to 100 nanometers (10-9 meter, 0.00000004 inch) in any dimension. Practically, they are bigger than a typical molecule but smaller than a typical solid. Examples are carbon nanotubes, fullerenes, nano silver (AgNP), nano titanium dioxide, nano zinc oxide, and combustion soot.

Regulation of nanomaterials is in its infancy, and the science in this area is also rapidly evolving (e.g., U.S. EPA 2008, Nanomaterial Research Strategy, EPA/600/S-08/00; Handy, von der Kammer et al., 2008, The Ecotoxicology and Chemistry of Manufactured Nanoparticles, Ecotoxicology 17:287-314).

Examples of nascent regulatory activities in this area:

  • EPA/FIFRA evaluation of silver nanoparticles;
  • EPA/TSCA information requirements under section 8(a), as well as Significant New Use Notice requirements; and
  • Consumer Product Safety Commission review under the Federal Hazardous Products Act.

iSTREEM

The American Cleaning Institute's iSTREEM model is a web-based model that integrates GIS technology to estimate concentration distributions of user-specified chemicals in streams. It has the potential to be used as a tier II assessment to EPA's Down the Drain, Consumer Exposure Pathway, and Probabilistic Dilution Model (PDM) screening tools.

The model segments rivers to model downstream flow. Sources draining to each segment can include wastewater treatment plant (WWTP) effluent, upstream input, tributary input, and industrial loads. Losses from each segment can include biodegradation and downstream transport. Input datasets such as river characteristics, drinking water intakes, and industrial discharge and WWTP characteristics are obtained from the US EPA. Additional input includes chemical fate characteristics, chemical loading parameters, and scale. Results are classified by the user and separated into River, WWTP, and Drinking Water Intake categories. Results can be viewed in the map window and downloaded in dbf (database) format. Access to the model can be obtained at http://www.istreem.org. iSTREEM is a powerful tool for estimating chemical distributions and identifying appropriate monitoring sites.

ETS’ TSCA support capabilities are described in our TSCA Compliance Support web page, titled “Toxic Substances Control Act Compliance: How ETS Can Help”.