EDF Health

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

By / Published: June 25, 2019

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.

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

Lead-based paint hazard standard – EPA takes step forward then fumbles

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: June 24, 2019

Tom Neltner, J.D., Chemicals Policy Director

On December 21, 2020, EPA signed a final rule setting the lead-based paint dust clearance standard to match the hazard standard in June 21, 2019 of 40 µg of lead in dust per ft2 on floors and 250 µg of lead in dust per ft2.

Note that President Biden’s Executive Order on Protecting Public Health and the Environment and Restoring Science to Tackle the Climate Crisis directs agencies to review the former administration’s regulations and actions, including the lead-based paint hazard standard. 

Last Friday, pursuant to a court order, the Environmental Protection Agency (EPA) signed a final rule[1] tightening its standards for lead in dust on floors and window sills for housing and child-occupied facilities built before 1978.  The agency essentially finalized the version it proposed a year ago despite failing to address significant concerns from the lead poisoning prevention community.

While the rule is a long overdue step forward, the agency fumbled its responsibilities in several critical areas: Read More »

Posted in Lead / Tagged | Comments are closed

New Report: Toxic Consequences – Trump’s Attacks on Chemical Safety Put Our Health at Risk

By Sam Lovell / Published: June 17, 2019

Sam Lovell, Project Manager.

Today, EDF released a report detailing the major threats to public health and future generations from the Trump Environmental Protection Agency’s (EPA) attacks on the 2016 chemical safety law. Just three years after Congress passed bipartisan legislation, the Lautenberg Act, to overhaul the Toxic Substances Control Act (TSCA), implementation of the law has gone dangerously off the rails – putting public health at risk.

“At almost every turn, the Trump administration has failed to live up to the letter and spirit of the historic bipartisan reform of TSCA that Congress passed in 2016. Toxic chemicals can cause cancers and other life-threatening illness. The American people expect the Environmental Protection Agency to live up to its mission and to protect them from these threats.  At the three-year anniversary of our overwhelmingly bipartisan reform of TSCA, EPA continues to ignore expert scientific staff and walk back protections for workers and consumers. ” said Senator Tom Udall.  “EPA leaders – starting with Andrew Wheeler – must change course, commit themselves to protecting the public, and carry out the Lautenberg Act as Congress wrote it.”

The report notes that recent history holds countless stark examples of what can happen when chemical risks are not adequately addressed. We risk making similar mistakes unless the current EPA fundamentally changes course in its implementation of the law. The Trump Administration is allowing new chemicals onto the market with little or no health information and only cursory safety reviews; ignoring real-world exposures when evaluating chemicals already in use today; blocking needed restrictions on dangerous uses of toxic chemicals; and denying the public access to health information on chemicals. These are not merely process problems: the consequences of the Trump EPA’s actions will be felt by our children and subsequent generations.

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Posted in Health policy, Industry influence, Public health / Tagged , | Comments are closed

The Trump EPA is setting back chemicals policies by decades

By / Published: June 13, 2019

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


Tacoma, WA 1972

As we approach the third anniversary of the historic passage of bipartisan legislation to overhaul our nation’s broken chemical safety system, we’re hearing that political appointees at the agency are gearing up to celebrate their “successes” in implementing the law.[pullquote]Even more disturbing than its individual actions are the methodical steps the Trump EPA is taking to dismantle decades of progress in our country’s chemicals policies.[/pullquote]

While the chemical industry may well have things to celebrate, it’s simply not the case for the rest of us:  Comments from former top EPA officials, members of Congress, state and local governments, labor groups, firefighters, water utilities, public health groups, and a broad range of environmental groups make crystal clear that there’s nothing warranting celebration.  EPA’s actions are threatening the health of American families.

But as I reflect on how implementation of the Toxic Substances Control Act (TSCA) has gone off the rails under the Trump EPA, even more disturbing than its individual actions are the methodical steps it is taking to dismantle decades of progress in our country’s chemicals policies.  In this post, I’ll briefly highlight five such policies and how this EPA is undermining them:

  • Pollution prevention
  • Inherent safety and hazard reduction
  • Protection of vulnerable subpopulations and environmental justice
  • Holistic, real-world risk assessment
  • Public right to know

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Posted in Health policy, Industry influence, Regulation, TSCA reform, Worker safety / Tagged , , , , | Read 2 Responses

The Trump EPA is illegally denying requests for public files on new chemicals

By / Published: June 3, 2019

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

For some time now, Environmental Defense Fund (EDF) has been requesting “public files” of new chemical notices the Environmental Protection Agency (EPA) receives under the Toxic Substances Control Act (TSCA).  The process is kludge-y to say the least.  We have to email our request to EPA’s Docket Center, and, typically, several weeks later the staff there copy the files that staff in the TSCA office have given them in response to our request onto a CD-ROM and snail-mail it to us.

This, despite the fact that EPA’s own regulations (see here and here) state unequivocally that EPA is to promptly make new chemicals’ premanufacture notifications (PMNs) and associated documents broadly available to the general public by posting them to electronic dockets.  One regulation states: “All information submitted with a notice, including any health and safety study and other supporting documentation, will become part of the public file for that notice, unless such materials are claimed confidential.”  The other regulation states that public files are to be made available in the electronic docket posted at http://www.regulations.gov.

We have blogged extensively about how, even once we receive the public files, they are rife with wholesale omissions, illegal redactions and myriad other problems.

After two years of our repeated requests to EPA to comply with its own regulations, it appears EPA may be taking a first step to try do so:  EPA recently announced (via email, but not anywhere on its website that we can find) that it will start posting PMNs and associated documents it receives in the future to its ChemView database, within 45 days of their receipt.  While this could be a welcome development, it does nothing to remedy EPA’s failure to provide access to the thousands of PMNs it has received in the past.  And it remains to be seen what EPA actually will and won’t be posting.

We’ll be watching closely to see when and what EPA actually makes available.  Part of the need for vigilance comes from a disturbing response we’ve been receiving from EPA’s Docket Center to some recent requests for new chemical public files:   Read More »

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

FDA finds surprisingly high levels of PFAS in certain foods – including chocolate cake

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: June 3, 2019

[Update: FDA has published a webpage on PFAS and released the data for the studies discussed in this blog].

Tom Neltner, J.D., Chemicals Policy Director and Maricel Maffini, Ph.D., Consultant

As reported by the Associated Press today, at a conference last week in Helsinki, Finland, the U.S. Food and Drug Administration (FDA) presented the results of three studies it conducted of 16 per- and poly-fluoroalkyl substances (PFAS) in various foods. A friend who attended the conference sent us photos of the poster. The results for samples of meat and chocolate cake purchased by the agency in October 2017 as part of its ongoing Total Diet Study (TDS) jumped out at us as surprisingly high and worth further investigation:

  • 17,640 parts per trillion (ppt) of perfluoro-n-pentanoic acid (PFPeA) in chocolate cake with icing. These levels suggest that the cake was contaminated from the intentional use of the chemical to greaseproof paper that contacted the cake rather than from an environmental source. We cannot find any evidence that FDA ever reviewed the safety of PFPeA as a food contact substance – meaning the manufacturer may have secretly designated it as Generally Recognized as Safe (GRAS). We also found little evidence – good or bad – of the health risks posed by this PFAS. We have reached out to FDA to learn more, but as of this blog posting the agency has not yet responded. This chemical was also found in chocolate milk at 154 ppt.
  • Nearly half (10 of 21) meat samples had quantifiable levels of perfluoroctanesulfonate (PFOS) with concentrations ranging from 134 ppt in a frankfurter to 865 ppt in tilapia. Unlike the chemical in chocolate cake, PFOS has been extensively studied because of widespread environmental contamination, especially around the facilities in Alabama and Minnesota where it was previously produced. It is associated with increased cholesterol, thyroid disease, testicular cancer, and decreased birth weight. While comparisons are complicated, the PFOS levels found in some of these meats were far greater than the 70 ppt health advisory set by the Environmental Protection Agency (EPA) for drinking water in May 2016. Two years later, the Centers for Disease Control and Prevention (CDC) proposed limits that are almost 7 times more protective than EPA’s, partly because more recent studies indicate the chemical may undermine the effectiveness of vaccines. Production of PFOS in the United States reportedly ended in 2002, though it is still made overseas and may have been imported paper. In 2016, FDA removed its approval to greaseproof paper with PFOS.

FDA’s poster also showed testing results from food produced around two PFAS contaminated areas. FDA found most of the 16 PFAS at varying levels measured in produce sold in farmer’s markets downstream of a PFAS production facility in the Eastern U.S. – presumably Chemours’ plant in North Carolina. The highest produce sample had 1,200 ppt and was purchased within 10 miles downstream of the production plant and short-chain PFAS were prevalent.

The other contaminated area was a dairy farm near an air force base in New Mexico. FDA found many of the 16 PFAS in the water and silage used to feed the cows but PFOS was the most prevalent among a few PFAS measured in the milk with levels higher than 5000 ppt. The agency also detected several PFAS in cheese produced by the farm in lower amounts than the milk. Many of the PFAS are likely from aqueous film forming foam (AFFF) used to fight fire and conduct firefighting training at the Air Force base.

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Posted in FDA, Food, GRAS, PFAS, Public health / Tagged , , | Read 2 Responses