EDF Health

More questions than answers: EDF submits extensive questions to EPA in advance of public meeting on new chemical reviews

By / Published: November 21, 2017

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

Environmental Defense Fund yesterday submitted questions to EPA that we hope are answered by the agency at the public meeting it is convening on December 6th on changes to its new chemicals reviews.

Despite providing some new documents in advance of the public meeting, details about EPA’s new policies and practices for reviewing new chemicals under the reforms made to TSCA by the Lautenberg Act remain scant.  We identified a number of serious concerns when these changes were first announced by Administrator Pruitt in a news release issued on August 7 – concerns that the meeting background materials EPA has provided only serve to heighten.

The questions we submitted today relate to our concerns in the following topics:

  • The statutory and scientific basis for EPA’s new policies, the timing of their application, and omissions from the new framework
  • EPA’s plan to use so-called “non-5(e) SNURs” in lieu of consent orders
  • Recent policy changes not included in EPA’s agenda for the public meeting
  • Public access to information
  • Confidential business information claims
  • Use of section 5(e) SNURs

EDF has been raising concerns for some time now over the recent redirection of the new chemicals program starkly away from the approach taken following last year’s enactment of the Lautenberg Act.

Many of the questions we’ve just submitted were formally submitted by letter to EPA’s Office of Pollution Prevention and Toxics (OPPT) more than 3 months ago, on August 16, 2017.  Unfortunately, we have yet to receive responses to them.  We hope they will be addressed at the December 6th meeting.

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EPA’s latest analysis shows perchlorate risks to fetal brain development

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: November 20, 2017

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

Pursuant to a consent decree with the Natural Resources Defense Council (NRDC), the Environmental Protection Agency (EPA) is developing drinking water regulations to protect fetuses and young children from perchlorate, a toxic chemical that inhibits the thyroid’s ability to make the hormone T4 essential to brain development. The rulemaking is part of a long process that began in 2011 when the agency made a formal determination that Safe Drinking Water Act standards for perchlorate were needed. Under the consent decree, EPA should propose a standard by October 2018.

In the latest step in that process, EPA’s scientists released a draft report in September that, at long last, answers questions posed by its Science Advisory Board in 2013: does perchlorate exposure during the first trimester reduce production of T4 in pregnant women with low iodine consumption? Does reduction in maternal T4 levels in these women adversely affect fetal brain development? According to EPA’s scientists, the answers are Yes and Yes.

For several years, EPA and the Food and Drug Administration (FDA) have developed and refined a model that would predict the effect of different doses of perchlorate on levels of T4 in pregnant women. The latest version of the model addresses women during the first trimester, especially those with low iodine intake. This is important because iodine is essential to make T4 (the number four indicates the number of iodine atoms present in the hormone); perchlorate inhibits its transport from the blood into the thyroid. The risk of perchlorate exposure to fetuses in the first trimester is greatest because brain development starts very early and is fully dependent on maternal T4. If the mother gets insufficient iodine to offset the perchlorate inhibition, she will not produce enough T4 for the fetal brain to develop properly. When free T4 (fT4) levels are low but without increase in thyroid stimulating hormone (TSH), the condition is known as hypothyroxinemia. When T4 production is lowered further, the pituitary gland releases TSH to increase T4 production by a feedback loop mechanism.

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Also posted in Drinking water, Emerging science, FDA, Food, Health policy, Perchlorate, Public health / Tagged , , , , , , , , , , | Authors: / Comments are closed

EPA proposes limits on hypochlorite bleach to reduce degradation to perchlorate

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: November 17, 2017

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

Every 15 years, the Environmental Protection Agency’s (EPA) Office of Pesticide Programs (OPP) reviews the safety of registered pesticides. The current cycle ends in 2022. As part of that process, the agency is evaluating the safety of hypochlorite bleaches. In January 2017, EPA decided it would consider the risks posed by degradation of the hypochlorite into perchlorate.

This is important for two reasons: 1) degraded bleach is less effective as a pesticide, and 2) perchlorate is a chemical that interferes with the production of thyroid hormone, a critical hormone for fetal and infant brain development.

On September 22, EPA proposed changes to the pesticide label to minimize the degradation for hypochlorite bleach used to disinfect drinking water, and the agency is accepting comments until November 21, 2017. The label would advise users to:

  • Minimize storage time;
  • Maintain pH of the solution between 11 to 13;
  • Minimize exposure to sunlight;
  • Store at lower temperatures; and
  • If practical, dilute with cool softened water upon delivery.

EDF submitted comments to EPA supporting EPA’s proposal and requesting specific changes to the proposed language, including making the advice to users mandatory. We also asked the agency to extend the label requirements to hypochlorite bleach used to treat produce and to disinfect food handling equipment. Bleach appears to be one of several significant sources of perchlorate contamination of food. Improving management conditions will reduce degradation and preserve effectiveness regardless of the whether the bleach is used in drinking water or to treat vegetables.

EPA’s proposal is an interim decision. We also were pleased to see that OPP is committed to continue working with EPA’s Office of Water (OW) in its assessment of the risks of perchlorate to pregnant women and young children. We asked OPP to incorporate the OW’s findings in additional interim registration decisions for all uses of hypochlorite bleaches.

 

Also posted in Health policy, Health science, Perchlorate, Public health / Tagged , , , | Comments are closed

Shifting the burden for toxics with a sneaky website: one more reason Dourson shouldn’t lead EPA toxics office

By Jack Pratt / Published: September 14, 2017

Jack Pratt is Chemicals Campaign Director

[Use this link to see all of our posts on Dourson.]

With Congress back from recess, it is slated to take up the nomination of Michael Dourson to run the toxics office at EPA. Here are links to our recent blog posts documenting why we are deeply concerned about his nomination:

Starting with work he did for the tobacco industry, Dourson has made a career downplaying concerns about chemicals, from harmful pesticides to cancer-causing solvents, paid for that work by the same companies that make or use those chemicals.

In addition to his work as a toxicologist-for-hire, Dourson and his firm, TERA, have provided more public-facing services.  One of these, done with funding from the American Chemistry Council, was the “Kids+Chemicalsafety” website, now defunct, but still available online at the Internet Archive.

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Pace and outcomes of EPA new chemical reviews appear to be on track

By / Published: June 6, 2017

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

The Environmental Protection Agency (EPA) yesterday updated its website to provide a current snapshot of the status of new chemical reviews it has been conducting under last year’s amendments to the Toxic Substances Control Act (TSCA).  The statistics show that, despite being faced immediately with a substantial increase in responsibilities and workload as a result of the major changes made to TSCA, EPA has made enormous progress in implementing the new requirements.

Because the changes made by the Lautenberg Act to TSCA’s new chemicals program were both extensive and immediately effective upon enactment, a temporary backlog developed while EPA implemented the new requirements in reviewing both chemicals that were under review at the time of the law’s passage and those that came in subsequently.

Yesterday’s announcement and the related statistics indicate that the backlog has markedly declined since January, falling from 300 to below 150 cases.  In a press release EPA says it is committed to eliminating the backlog entirely by July.

Equally important in the statistics is the fact that many more chemicals are being subject to orders imposing conditions on their commercialization, relative to the old law:  For about half of the reviews completed to date, EPA has issued a consent order.  This is to be expected:  The new law requires EPA to issue such orders whenever it either lacks sufficient information to evaluate a new chemical, or makes a risk- or exposure-based finding that indicates potential concern.  In such cases, the orders must impose conditions sufficient to mitigate the concern.

Yesterday’s announcement is welcome.  EPA needs to stay the course.  And the chemical industry needs to recognize that restoring public and market confidence in our chemical safety system requires a robust new chemicals program.

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Another tragic death — time for EPA to ban high-risk chemical paint strippers

By Lindsay McCormick / Published: June 5, 2017

Lindsay McCormick is a Project Manager.  

A few weeks ago, a 21-year-old man tragically passed away after being overcome by chemical fumes while refinishing a bathtub.  The young man was working for a small painting business in Tennessee.  His death is currently being investigated by the Occupational Safety and Health Administration (OSHA), but is suspected to have been caused by methylene chloride exposure.  If confirmed, this would add to the dozens of reported deaths caused by the chemical’s use in paint stripping products over the past several decades.

The Environmental Protection Agency (EPA) has within its grasp the ability to prevent this type of tragedy from happening again. In January, EPA proposed to ban methylene chloride in paint and coating removal products – including those used for bathtub refinishing, and is considering a ban on such use of another highly toxic chemical called N-methylpyrrolidone.  The agency based its proposal on an extensive assessment of the scientific literature, which demonstrated not only lethal risks from acute methylene chloride exposure but also other health impacts from both short- and long-term exposure to both chemicals.

Products containing these chemicals are available at hardware and other retail stores across the country, and unless EPA acts promptly to finalize a ban, there will surely be more avoidable deaths and other health impacts due to use of high-risk chemical paint strippers.  In EDF’s recent comments to EPA, we strongly urged it to finalize these bans as soon as possible to protect public health.  EPA should not wait for another reason to take action.

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