EDF Health

Selected tag(s): Chemical testing

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.

Read More »

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

Understanding PFAS: Why a broad, transparent PFAS Testing Strategy is needed

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

Maria Doa, Senior Director, Chemicals Policy; Lauren Ellis, Research Analyst; and Lariah Edwards, Post-Doctoral Fellow

EDF this week sent EPA a letter identifying opportunities for the agency to improve the effectiveness and transparency of its strategy for testing per- and polyfluoroalkyl substances (PFAS).

EPA unveiled its National PFAS Testing Strategy (Testing Strategy) last fall, laying out its plan to better understand the class of chemicals and inform its future regulatory efforts. PFAS are a large group of synthetic chemicals used to impart water, oil, grease, and stain resistance to various materials, and they are used in hundreds of everyday products, from water-proof clothing to grease-proof food packaging. By its own count, EPA says there are more than 12,000 individual PFAS.

In their letter to EPA, EDF analyst Lauren Ellis and post-doctoral fellow Lariah Edwards commended the agency for developing a strategy to address some of the significant data gaps that exist around PFAS and committing to use its authority under the Toxic Substances Control Act (TSCA) ‒ the country’s main chemical safety law ‒ to require manufacturers to provide toxicity data on the chemicals.

As the letter points out, however, in its current state, the Testing Strategy lacks sufficient detail and is too narrow to fulfill the agency’s intended purpose to understand and regulate PFAS in a way that is protective of both human health and the environment. Read More »

Posted in Health science / Also tagged , | Comments are closed

Testing analysis for TSCA new chemicals embraced by EPA’s Beck has serious omissions

By / Published: May 11, 2018

Richard Denison, Ph.D., is a Lead Senior Scientist.  Ryan O’Connell, EDF High Meadows Fellow, and Stephanie Schwarz, EDF Legal Fellow, assisted in the research informing this post.

[UPDATED 5-15-18:  See clarifications and a correction added in brackets below.]

As noted in a previous blog post, EDF recently filed a request for an extension of the public comment period on EPA’s draft Alternative Testing Methods Strategic Plan under the Toxic Substances Control Act (TSCA).  This was due to the lack of public access to documents that Dr. Nancy Beck had prominently alluded to, without identifying, at EPA’s April 10, 2018, public meeting on the draft plan.  EDF requested a 30-day extension starting once the documents were placed in the docket for the draft plan.

On April 27, EPA provided a 15-day extension after placing the documents in question into the docket.  It turns out the documents (a letter and an attached spreadsheet) are from two animal welfare organizations, People for the Ethical Treatment of Animals (PETA) and Physicians Committee for Responsible Medicine (PCRM).  They are not, were not submitted as, and apparently were not intended to be, comments on the draft plan, however; rather, they raise the groups’ concerns over the increase in testing of new chemicals under the new TSCA, based on an analysis they said indicates EPA more frequently included testing provisions when issuing consent orders for new chemicals after passage of the new law than it did before.

Given that the documents PETA and PCRM submitted were not comments on the draft plan and were not submitted in that context, it is all the more curious why Dr. Beck so prominently noted and expressed such enthusiasm for them at the EPA public meeting held about the draft plan – especially because it appears she did so before EPA had conducted any serious review of the documents, which as you’ll see below, is a big problem.

I suspect Dr. Beck’s interest in the PETA/PCRM letter and analysis has little to do with sparing laboratory animals and much more to do with her seeing the documents as providing a useful pretext for her concerted efforts to avoid imposing testing requirements on new chemicals – a clear priority for her previous employer, the American Chemistry Council (ACC).  Industry has incentives to avoid testing due to its costs and the risks that testing may reveal a chemical presents significant risks to health or the environment.

Now that we’ve had a chance to review the PETA/PCRM documents, I want to use this post to highlight two things:

  • First, the PETA/PCRM analysis erroneously understated the extent of testing EPA required prior to the passage of the Lautenberg Act, because it failed to count any of the testing requirements for two-thirds of the new chemicals it examined for which EPA issued consent orders in 2015 and 2016.
  • Additional context is required when assessing the extent of testing of new chemicals EPA was mandating under the new TSCA, which was not provided in the PETA/PCRM analysis.

Read More »

Posted in Health policy, TSCA reform / Also tagged , , | Read 2 Responses

EDF requests extension of comment period on TSCA Alternative Testing Strategic Plan due to key document missing from docket

By / Published: April 19, 2018

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

Last night EDF submitted a request to the Environmental Protection Agency (EPA) to extend the public comment period on its draft Alternative Testing Methods Strategic Plan under the Toxic Substances Control Act (TSCA).

EPA held a public meeting about the draft Strategic Plan on April 10, 2018.  At that meeting, Dr. Nancy Beck prominently highlighted an analysis that EPA had received from a stakeholder that she described as robust and extensive, and her description of the analysis suggested that it has or could significantly influence EPA’s consideration of the issues raised by the draft Strategic Plan.  When asked if EPA would make this analysis available to the public, an EPA official stated that it would be made available.  But the analysis has not yet been published to the docket.  The due date for comments on the draft Plan is a week from today, April 26, 2018.

Given the emphasis Dr. Beck placed on the analysis and the apparently extensive nature of it, EDF believes the public should be provided access to the document and ample time to review, and if desired, comment on it.  Hence we have requested that:

1)  EPA publish a copy of the relevant analysis to the docket for the draft Strategic Plan.

2)  EPA extend the public comment period by 30 days after it publishes the relevant analysis in the docket.

Because the deadline is impending, EDF requested that EPA respond to this request within three business days, i.e., by Monday, April 23.

Posted in Health policy, TSCA reform / Also tagged , | Comments are closed

“Big data” comes to chemical testing – How to ensure more is better

By / Published: February 24, 2016

Jonathan Choi is a chemicals policy fellow.

EDF Senior Scientist Dr. Jennifer McPartland contributed to this post.

The beginning of this century will no doubt be known for a lot of things. In the biological sciences, I predict it’ll be known for big data. It’s hard to wrap your head around just how far we’ve come already. For example, the data chips that sing “happy birthday” to your loved ones in those horrendously overpriced cards have more computing power than the Allies did in 1945. When I first started using computers, the 5.4” floppy disk was being replaced by the new 256Kb 3.5” disk. Now in Korea, you can get 1 GB per second internet speeds for $20 a month. That’s around 4000 floppy disks of data per second for about as much as I spend every week at the burrito place down the street.

In the biological sciences, we’ve seen an explosion of new ways to generate, collect, analyze, and store data. We’re photographing the world’s biodiversity and sharing it with crowdsourced taxonomists. We’re creating a database of the genomes of the world’s organisms. We’re mapping chemical exposures (our exposome), inventorying the microbes that live in our guts (our microbiome), ripping apart cells and sequencing every bit of messenger RNA that floats around inside (our transcriptome), and much more.

So, it’s not too surprising that regulatory agencies like EPA are pushing their own efforts to amass large quantities of data to help meet their missions. EPA has the unenviable task of reviewing tens of thousands of chemicals currently on the market with little health and safety data, on top of hundreds of new chemicals banging at its door each year. As we have written on numerous occasions, the agency clearly needs a better law that gives it greater authority to get the data it needs to effectively evaluate and manage chemical risks. But, given the information abyss in which we operate, we could definitely stand to adopt new testing approaches that generate at least screening level data on chemicals faster.   Read More »

Posted in Emerging science, Emerging testing methods, Health science / Also tagged , | Comments are closed

Links to essential reading on Senate and House TSCA reform legislation

By / Published: December 22, 2015

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

[UPDATE 2/26/16:  Updated versions of (1) our detailed side-by-side comparison of Senate and House bills — now with bill section references — and (2) our 5-part series have been posted below.]

On December 17, 2015, the full Senate passed the Frank R. Lautenberg Chemical Safety for the 21st Century Act (S. 697, the Lautenberg Act), which would amend the nearly 40-year-old Toxic Substances Control Act (TSCA).

The House of Representatives already passed its TSCA reform bill in June, the TSCA Modernization Act of 2015, H.R. 2576.

Next up in the New Year will be efforts to reconcile these two bills.  In anticipation of this, I am posting here updated analyses of the two bills that examine how and to what extent they would address key flaws in TSCA.  These analyses include:

  • brief and detailed side-by-sides of TSCA and the two bills,
  • a comparison of how the bills deal with the contentious issue of preemption of state authority,
  • a comparison of how well the bills meet the Administration’s principles for TSCA reform, and
  • an earlier blog post on the importance of understanding which chemicals are in use today.

All of these materials (including this post) are available at blogs.edf.org/health.

ANALYSES:

Posted in Health policy, TSCA reform / Also tagged , , , , | Authors: / Comments are closed