EDF Health

Time for a new age for new chemicals

By EDF Blogs / Published: September 20, 2023

By Maria Doa, PhD, Senior Director, Chemicals Policy, Samantha Liskow, Senior Counsel, and Colin Parts, Legal Fellow

NOTE: This is the first of a series about EPA’s regulation of new chemicals.

What Happened?

EPA recently proposed regulations to govern how it reviews companies’ pre-manufacture notifications for new chemicals before those chemicals can go on the market.

Why It Matters

Unfortunately, as we noted in our comments to EPA [PDF, 721KB], the proposal falls significantly short of implementing the fundamental changes needed to ensure the safety of any new chemicals allowed onto the market.

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Posted in Chemical regulation, Industry influence, TSCA / Tagged , , , | Authors: / Comments are closed

Toxic Chemicals: Regulatory exemptions prioritize industry wants over safety needs

By Maria Doa, PhD, Senior Director, Chemicals Policy / Published: December 2, 2022

A rubber stamp lies on its side to the right of the photo. To the left, you see the stamped image of a skull and crossbones and the words Toxic Substances

By Maria Doa, PhD, Senior Director, Chemicals Policy

What’s the Issue?

EPA grants exemptions from full safety reviews for approximately half the new chemicals submitted by the chemical industry. Once those exemptions are granted, EPA very rarely revises or revokes them—even in the face of new information.

The Toxic Substances Control Act allows EPA to grant an exemption from a full safety review only if it determines that the chemical will not present an unreasonable risk. That’s a high standard—and one that many exemptions do not meet.

Why it Matters:

  • The chemical industry takes maximum advantage of exemptions given the abbreviated safety review and the industry’s ability to keep their use of new chemicals under the radar. For example, the chemicals that get exemptions don’t go on the national inventory of chemicals that are in use.
  • For years, EPA has granted exemptions for chemicals that can have long-term negative impacts on human health and the environment. They include hundreds of exemptions for PFAS, “forever chemicals” known to contaminate our water supplies and farmland. And it’s not just PFAS. EPA has granted exemptions for other types of persistent, bio-accumulative, toxic (PBT) chemicals that can have lasting impacts on people and the environment.
  • These exemptions often contradict TSCA’s requirement that EPA consider the risks from a chemical throughout its lifecycle. That includes the risks for vulnerable groups who may be more susceptible to the chemical or who are more highly exposed, such as frontline communities.
  • EPA does not typically consider the cumulative impacts of multiple exempted chemicals on frontline communities, consumers, or the environment.

Our Take: EPA has an important opportunity to address overuse of TSCA exemptions.

Next Steps:

  • EPA should revisit the exemptions it has already granted. The agency should determine that chemicals truly do not present an unreasonable risk—particularly to vulnerable populations—throughout their lifecycles. EPA should focus first on chemicals that can have long-lasting impacts on health and the environment, like PFAS and other PBTs.
  • Before granting any new exemptions, EPA should consider the combined impacts throughout the lifecycle of these chemicals on all stakeholders, especially frontline communities. EPA Administrator Regan recently said EPA would be embedding environmental justice into the DNA of EPA. This is another opportunity for EPA to do just that.
Posted in Frontline communities, Industry influence, Public health, TSCA / Tagged , , , , , , , | Authors: / Comments are closed

EPA’s Significant New Use Rules under TSCA must reflect its policy goals

By Lauren Ellis / Published: January 6, 2022

Lauren Ellis, Research Analyst, Environmental Health 

We recently submitted comments to the Environmental Protection Agency (EPA) on a subset of proposed Significant New Use Rules (SNURs) published by the New Chemicals program under the Toxic Substances Control Act (TSCA). We commend EPA for issuing these proposed SNURs. Our review of some of the SNURs, however, raised concerns about chemical releases to the environment, risks to consumers, and the absence of worker protections. We believe EPA can address many of these concerns by following through on its stated policy goals. 

For all the chemicals in this batch, EPA had previously issued “consent orders” – which impose restrictions on a new chemical – because the agency found at the time of their initial review for market entry that the chemical substances may present an unreasonable risk to health or the environment. We strongly support EPA’s use of SNURs to follow up on consent orders it issues, as a consent order only applies to the original company that submitted a premanufacture notice (PMN) to EPA to domestically manufacture or import a new chemical. 

A SNUR is a separate action that requires any company seeking to engage in a “significant new use” identified in the SNUR to notify EPA at least 90 days before beginning that use, triggering EPA’s review of the potential new use. For new chemicals that received orders, a SNUR can conform to the order – meaning it mirrors the conditions in the consent order for the chemical – or it can apply more broadly to activities or uses that are beyond the scope of the consent order. Either way, SNURs enable the agency to review potentially risky uses prior to their commencement. 

In our comments, we call for four major changes to a subset of the proposed SNURs: 

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EPA needs to stop misleading the public and its peer reviewers about the data it has obtained from the European Chemicals Agency

By Richard Denison / Published: September 12, 2019

Richard Denison, Ph.D., is a Lead Senior Scientist.

In numerous assessment documents issued by the Environmental Protection Agency (EPA) developed in its implementation of the Toxic Substances Control Act (TSCA), EPA cites as a source the European Chemicals Agency (ECHA).  ECHA is the agency that administers the European Union’s (EU) REACH Regulation, which (unlike TSCA) requires the registration of chemicals in commerce by companies that wish to continue to produce and use the chemicals in the EU.

When companies register chemicals under REACH, they are required to develop and submit a “dossier” of certain information on production and use as well as on physical-chemical properties, fate, hazard, exposures and risks.  ECHA then makes information available on its website.

In its draft risk evaluations for the first 10 chemicals undergoing evaluations under TSCA, as well as in some of its support documents for high-priority substance designations under TSCA, EPA has heavily relied on these dossiers.  But in doing so, EPA has grossly mischaracterized the source and nature of the data it references as coming from ECHA.

EDF has been raising concerns about EPA’s mischaracterizations for some time now (see section 1.E of our comments on EPA’s draft risk evaluation for 1,4-dioxane), but they persist.  And as recently as yesterday, members of the peer review panel reviewing EPA’s draft documents have been led by EPA statements and citations to assume a degree of completeness and government review of these data that is simply false.

EPA needs to immediately cease and desist in its mischaracterizations.  Read More »

Posted in Health policy, Health science, Industry influence, Regulation / Tagged , , | Comments are closed

Hey Trump EPA, your extreme bias in favor of the chemical industry is showing again

By Richard Denison / Published: July 2, 2019

Richard Denison, Ph.D., is a Lead Senior Scientist.

[See UPDATE in brackets below.]

The Trump Environmental Protection Agency (EPA) has just released drafts of two more chemical risk evaluations it has conducted under the Toxic Substances Control Act (TSCA).  One is for the likely human carcinogen and neurotoxicant 1,4-dioxane, which contaminates public water systems serving more than 7 million Americans in 27 states at levels exceeding the level EPA has traditionally (until now) aimed to meet for general population exposures.  The other is for the flame retardant hexabromocyclododecane, or HBCD, a persistent, bioaccumulative and toxic (PBT) chemical – toxic to human development and highly acutely and chronically toxic to aquatic organisms – that has been banned or heavily restricted in most of the rest of the developed world.

As might have been expected of the Trump EPA, the draft risk evaluations wholly exonerate HBCD and largely do so for 1,4-dioxane.  Especially in the latter case, EPA achieves its improbable finding through quite a sleight of hand:  EPA simply excludes most exposures to the chemical from the scope of its risk evaluation.[pullquote]Trump EPA political appointees have repeatedly argued that the agency needs to be doing a better job at “risk communication.”  I guess we now know what that means.[/pullquote]

Once finalized, EPA’s determinations that these chemicals “do not present an unreasonable risk” will mean it has no obligation or authority to impose any restrictions on their manufacture, processing, distribution, use, recycling or disposal.

We will be looking at these documents more closely in the very limited time EPA has provided for the public to review and comment on them.  But I want to draw attention right off the bat to a telling aspect of how the Trump EPA has presented its risk determination for 1,4-dioxane.

Read More »

Posted in Health policy, Industry influence, Regulation, TSCA reform / Tagged , , , | Comments are closed

EPA says PV29 is perfectly safe. The EU, citing concerns and a dearth of data, begs to differ.

By Richard Denison / Published: May 7, 2019

Richard Denison, Ph.D., is a Lead Senior Scientist.

In contrast to the Environmental Protection Agency’s (EPA) asserted clean bill of health for Pigment Violet 29 (PV29) in its draft risk evaluation, authorities under the European Union’s REACH program have formally declared the chemical to be a suspected persistent, bioaccumulative and toxic (PBT) substance and a suspected very persistent and very bioaccumulative (vPvB) substance.  Either designation, if confirmed, would classify PV29 as a substance of very high concern (SVHC) under the EU’s REACH Regulation.

In EDF’s earlier comments on EPA’s draft risk evaluation, we noted that PV29 had been proposed to be so listed under REACH and to undergo a full substance evaluation in 2021.  Since we filed those comments, the European Chemicals Agency (ECHA) has published an update to its Community Rolling Action Plan (CoRAP) that now formally designates PV29 as a “suspected PBT/vPvB” that will be subject to a full substance evaluation.  The listing is accompanied by a “justification document” for PV29’s designation.

The justification document, prepared by the Belgian Competent Authority (BE CA) under REACH and endorsed by REACH authorities, echoes many of the concerns about PV29 and EPA’s draft risk evaluation that EDF had raised in our earlier comments.   Read More »

Posted in Health policy, International, TSCA reform / Tagged , , | Comments are closed