EDF Health

Too little, too late: Why SNURs alone are not a sufficient alternative to consent orders for new chemicals

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

The Environmental Protection Agency (EPA) is in the process of making some major changes to its policies and practices governing new chemical reviews.  This post discusses one of the most troubling ones.  

The SNUR-only approach EPA is now deploying differs dramatically from and provides far less risk protection than would result from it simply doing what the law requires:  using orders, with SNURs as backup.

As I have previously described, last year’s Lautenberg Act made extensive changes to section 5 of the Toxic Substances Control Act (TSCA), which governs the review of new chemicals prior to their manufacture and use.  Among these changes is a requirement that EPA must evaluate potential risks, and mitigate potential unreasonable risks, of a new chemical under its “conditions of use,” which the new law defines to include “reasonably foreseen” circumstances of production, processing, distribution, use or disposal, as well as those intended by the company submitting notice of the new chemical to EPA.  If EPA identifies potential risk or significant exposure or lacks sufficient information on a new chemical, it must issue an order prohibiting or limiting the conditions of use of the chemical in order to mitigate any unreasonable risk.

After passage of the Lautenberg Act until recently, and in keeping with the new law, if EPA’s review identified risk concerns relating to conditions of use beyond those strictly identified by a company submitting a new chemical notice to EPA, the agency made a “may present an unreasonable risk” finding and pursued development of a consent order with the company sufficient to ameliorate those concerns.  (While EPA has authority to issue unilateral orders, it typically negotiates with the company to arrive at a consent order that both parties sign.)

Now EPA is indicating it will instead make a “not likely to present an unreasonable risk” finding for the intended conditions of use, and says it can address any concerns over reasonably foreseen uses without issuing an order by developing only a significant new use rule (SNUR).  This “SNUR-only approach” is inconsistent with the law, a matter I won’t discuss further here.  However, it also raises a host of policy concerns, some of which I lay out in this post.

The SNUR-only approach EPA is now deploying differs dramatically from and provides far less risk protection than would result from it simply doing what the law requires:  using orders, with SNURs as backup.

There are ample reasons why Congress called on EPA to use orders to address concerns and then use SNURs as backup:  Orders (including consent orders) and SNURs are not created equal.  This post discusses 12 key differences, with respect to:

(Spoiler alert:  Deep dive ahead. Let me apologize to and warn readers in advance that this post gets rather into the weeds, as the issues are complicated and the details are important.)   Read More »

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More questions for EPA on identifying chemicals for prioritization under TSCA

Lindsay McCormick is a Project Manager.  

When EPA finalized its framework prioritization rule under TSCA last June, the agency deleted its proposed approach to identifying potential candidate chemicals for prioritization.  EDF had supported EPA’s initial proposed rule, and EPA’s decision to delay this process to allow for additional stakeholder engagement tracks closely with the comments chemical industry groups submitted on that proposed rule.

EPA is now holding a public meeting on December 11th to discuss its proposed approaches and get input from stakeholders.  As with the upcoming meeting on new chemical reviews, EPA is accepting questions ahead of the meeting.

In response, EDF submitted a number of questions to the agency on Monday, relating to our concerns in the following areas:

  • EPA’s stated intention to significantly exceed its statutory minimum of designating 20 low-priority chemicals within the law’s specified timeframe.
  • EPA’s passive approach to utilizing its new authorities to fill data gaps on chemicals before they enter the prioritization and risk evaluation processes.
  • The need to ensure transparency with respect to health and safety studies and underlying data used by EPA to identify candidate chemicals for prioritization.
  • Specific concerns regarding EPA’s proposed approaches, including to utilize Canada’s Chemicals Management Plan as a model and to use EPA’s Safer Chemicals Ingredient List (SCIL) as a basis for identifying low-priority chemicals.

Read our full list of questions here for more details.

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

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

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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EPA proposes limits on hypochlorite bleach to reduce degradation to perchlorate

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.


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

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.

Read More »

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