EDF Health

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EDF files comments on two EPA proposals affecting EPA’s and the public’s access to chemical information under TSCA

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

Yesterday Environmental Defense Fund (EDF) filed comments on two EPA proposals (here and here) that will have major impacts on what chemical information EPA obtains and the public has access to.  While EPA risk evaluations and risk management actions (such as they are) often garner the lion’s share of stakeholder attention, the 2016 amendments to the Toxic Substances Control Act (TSCA) also made sweeping changes to EPA’s authority and duty to obtain better information on chemical uses, hazards and exposures, and to rein in rampant industry claims aimed at keeping much of that information hidden from public view.

As readers of this blog know, the extent of chemical information available to the agency and disclosed to the public has been a major point of controversy under the Trump EPA.  Three years after passage of the reforms to TSCA, EPA has yet to use its expanded information authorities even once, despite major data gaps for the chemicals it is prioritizing and evaluating.  In some cases, EPA has asked companies to voluntarily submit information without any safeguards against selective reporting.  EPA has then sought to deny public access even to submitted health and safety studies, arguing they are confidential despite TSCA’s clear prohibition on protecting such information from public disclosure; see here and here.

So EPA proposals that directly affect both what information is submitted to EPA and public access to it warrant serious scrutiny.  I’ll describe both proposals below, but as a preview I first want to highlight some of the key themes detailed in EDF’s comments:

  • EPA continues to resist acknowledging that the 2016 TSCA reforms changed the substantive standard governing confidentiality by imposing new requirements on top of those EPA has relied on in the past in regulations it promulgated pursuant to the Freedom of Information Act (FOIA). In both proposals, EPA must acknowledge the change and incorporate all of the law’s new requirements, which Congress enacted to place new limits on what information is eligible for protection from public disclosure.
  • In one of its proposals, EPA has proposed welcome changes that appear intended to make EPA’s review of confidentiality claims more efficient, by clarifying what companies can and cannot claim as confidential and what substantiation they need to provide to support their claims. However, it falls short of that goal and omits several key provisions that must be incorporated when the proposal is finalized.
  • The other proposal is far less robust and would continue to rely on obsolete regulatory provisions that do not reflect the law’s new requirements. As a result, it is also wholly inconsistent with the first proposal even with respect to the analogous procedures for claim assertion, substantiation and EPA review.
  • In the name of burden reduction, EPA has proposed to continue existing exemptions from chemical information reporting, and to add major new exemptions. If finalized, these exemptions will negatively impact EPA’s access to information on chemicals’ conditions of use, releases and potential exposures that it needs to carry out its duties under reformed TSCA.  The consequences of EPA’s failure to obtain robust information on chemicals it is reviewing were amply demonstrated in critical comments ($) the agency received at last week’s meeting of EPA’s Scientific Advisory Committee on Chemicals (SACC) held to peer review EPA’s first draft risk evaluation under TSCA.

Read More »

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Report: Staggering amounts of toxic chemicals produced across America

Alissa Sasso is a Chemicals Policy FellowRichard Denison, Ph.D., is a Lead Senior Scientist.

[Cross-posted from EDFVoices blog]

Recent spills in West Virginia and North Carolina cast a spotlight on toxic hazards in our midst. But as bad as they are, these acute incidents pale in scope compared to the chronic flow of hazardous chemicals coursing through our lives each day with little notice and minimal regulation. A new report by EDF, Toxics Across America, tallies billions of pounds of chemicals in the American marketplace that are known or strongly suspected to cause increasingly common disorders, including certain cancers, developmental disabilities, and infertility.

While it’s no secret that modern society consumes huge amounts of chemicals, many of them dangerous, it is surprisingly difficult to get a handle on the actual numbers. And under current law it’s harder still to find out where and how these substances are used, though we know enough to establish that a sizeable share of them end up in one form or another in the places where we live and work.

Our new report looks at 120 chemicals that have been identified by multiple federal, state and international officials as known or suspected health hazards. Using the latest, albeit limited, data collected by the U.S. Environmental Protection Agency, we identify which of these chemicals are in commerce in the U.S.; in what amounts they are being made; which companies are producing or importing them; where they are being produced or imported; and how they are being used. An interactive online map accompanying the report lets the user access the report’s data and search by chemical, by company, by state, and by site location.

Among our findings:  Read More »

Posted in EPA, Health Policy, TSCA Reform / Also tagged , , | Comments are closed

6 years in the making: A new and improved snapshot of U.S. chemical manufacture

Richard Denison, Ph.D., is a Senior Scientist.   Alissa Sasso is a Chemicals Policy Fellow.

Well, it’s finally hit the street:  Today, the Environmental Protection Agency (EPA) released information on the manufacture and use of nearly 7,700 industrial chemicals in 2011.  The data were collected last year under a revamped Chemical Data Reporting (CDR) program, and is the first update of such information since way back in 2005, the year of Hurricane Katrina and Star Wars Episode III.

In releasing the data, EPA Administrator Lisa Jackson noted:  “The CDR data also highlight the clear need for TSCA reform. Updating this critical law will ensure that EPA has access to the tools and resources it needs to quickly and effectively assess potentially harmful chemicals, and safeguard the health of families across the country.”

Getting even to this point has been a long and bumpy road.  Just getting from the proposed to a final CDR rule took over 16 months, with EPA having to endure not one but two nearly six-month regulatory reviews by the Office of Management and Budget and the chemical industry’s efforts to delay and dilute the rule.  It then took another year for EPA to collect the data, in no small part thanks to repeated efforts by the chemical industry and its allies in Congress to further delay the program.

Finally, it’s taken EPA six more months to compile and process the data in preparation for today’s release – though that’s a decided improvement over the 21 months it took EPA to release the data collected in the last cycle (the faster pace due in part to a requirement this time around for electronic reporting, a feature the chemical industry and its Congressional allies opposed).

So what do the new data reveal?  EPA has provided some nice summary materials, which we won’t duplicate here.  See especially the table on this page.  We’ll have more to say on this as we further analyze the data, but here are a few important things to note:

  • While 7,674 chemicals were publicly reported, these are limited to those being produced in or imported into the US in 2011 at volumes above the reporting threshold of 25,000 pounds per year per site.
    • The count excludes the likely much larger number of chemicals produced or imported at volumes below the reporting threshold, as well as the many chemicals exempt from reporting, such as most polymers.
  • Nearly 33,000 “records” have been made available by EPA.  Each record represents a single chemical reported by a single site of a company producing or importing that chemical.
    • In contrast to EPA’s reporting in the last cycle, a record for every single chemical-single site combination has been provided even if the information provided in the record is confidential business information (CBI).  In this way, the extent and nature of CBI claims is far clearer than was the case in the last cycle.
  • Extent of CBI claims:  Of all of the reported elements in these records that could potentially have been claimed CBI, about 16% were so claimed.  But that percentage varied a lot among the elements.
    • For 624 records (about 2%), the chemical identity was not provided and instead replaced with a unique identifier called an accession number.  These are new chemicals that are listed on the confidential portion of the TSCA Inventory, which are the only chemicals for which EPA allows chemical identity to be claimed CBI.
    • For 3,420 records (10.4%), the company claimed its identity to be CBI.
    • For 9,686 records (29.4%), the company claimed its domestically manufactured production volume to be CBI.
    • For 10,351 records (31.5%), the company claimed its exported volume to be CBI.

More to come, so stay tuned!

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Exposing our ignorance: EPA study reveals barren exposure data landscape

Jennifer McPartland, Ph.D., is a Health Scientist.

This past November, EPA scientists published a sobering paper, “The exposure data landscape for manufactured chemicals,” in the journal Science of the Total Environment.  The paper reveals how little systematic information we have about human and environmental exposures to the thousands of chemicals in use today.

The aim of the study was “to define important aspects of the [chemical] exposure space and to catalog the available exposure information for chemicals being considered for analysis as part of the U.S. EPA ToxCast screening and prioritization program.”  Its conclusion:  “The results suggest that currently available exposure data are insufficient to provide the evidence base required to inform risk assessment and public health decision making.”  Not good, but not surprising.  Read on for more detail. Read More »

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No orphan left behind: Health and environmental NGOs support EPA’s proposed paired rules to address high production volume “orphan” chemicals

Richard Denison, Ph.D., is a Senior Scientist.  Allison Tracy is a Chemicals Policy Fellow.

Environmental Defense Fund today submitted comments along with 15 other health, environmental justice and state and national environmental organizations, in support of EPA’s proposed rule to address the final batch of 45 “orphan” chemicals that were never sponsored under the agency’s earlier High Production Volume (HPV) Challenge Program.

An earlier post to this blog highlighted and applauded the novel, innovative and efficient approach EPA has proposed, which actually entails the coupling of two rules:

(1) a test rule for 23 of these HPV chemicals for which EPA can make the requisite exposure findings to require testing, combined with:

(2) a Significant New Use Rule (SNUR) for the other 22 HPV chemicals for which EPA cannot presently make such findings, which requires companies to notify EPA if their production or use of those chemicals changes so as to increase the potential for exposure and then warrant testing.

The comments we filed today reiterate our strong support for this approach – and propose that the same approach be extended to several additional batches of HPV chemicals that still lack a basic set of hazard data.

Read More »

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REACH starts to earn its “A”: 20 chemicals headed to the Candidate List and 13 to Authorization

Allison Tracy is a Chemicals Policy Fellow. Richard Denison, Ph.D., is a Senior Scientist.

The European Chemicals Agency (ECHA) has been busy this week implementing the EU’s chemical regulation, REACH (short for Registration, Evaluation, Authorization and Restriction of Chemicals).

On Monday, ECHA announced it has added 20 more Substances of Very High Concern (SVHCs) to REACH’s Candidate List.  These SVHCs are now eligible for later addition to Annex XIV, the list of SVHCs subject to Authorization.

Separately, the agency today forwarded its final recommendation that 13 chemicals already on the Candidate List be formally added to Annex XIV.  (We had blogged earlier about ECHA’s initial recommendation proposing these 13 SVHCs for Authorization.)  If the European Commission confirms this addition, after a specified sunset date, the use of these will be allowed only if specifically authorized by EU authorities.  Read More »

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