EDF Health

Selected tag(s): Lautenberg Act

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 »

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

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.

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

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.

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

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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This speaks volumes: Industry rushes in to defend EPA’s new TSCA regulations

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

Environmental Defense Fund has made no secret of our view that many elements of the final framework rules issued by the Trump EPA in July to implement recent reforms to the Toxic Substances Control Act (TSCA) are contrary to law and fail to reflect the best available science.  The rules EPA had proposed in January were heavily rewritten by a Trump political appointee, Dr. Nancy Beck, who until her arrival at the agency at the end of April was a senior official at the chemical industry’s main trade association, the American Chemistry Council (ACC).

In our view, the final rules largely destroyed the careful balance that characterized the efforts to reform TSCA and the final product of that effort, the Lautenberg Act.  In many respects, the final rules governing how EPA will identify and prioritize chemicals and evaluate their risks now mirror the demands of the chemical industry, reflected in comments they had submitted earlier – some of which Beck herself had co-authored.

These are among the reasons EDF as well as other NGOs and health and labor groups have had no choice but to file legal challenges to these rules.

Lest you have any doubt that the final rules are heavily skewed in industry’s direction, a development in these legal cases just yesterday should dispel it.  Read More »

Posted in EPA, Health Policy, Industry Influence, TSCA Reform / Tagged | Read 1 Response

One year and counting: On its first anniversary, near-term threats abound to implementation of our strong new chemical safety law

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

This week marks the first birthday of the Frank R. Lautenberg Chemicals Safety for the 21st Century Act, which was signed into law by President Obama on June 22, 2016, after passing the Senate and House with overwhelming bipartisan support.

If balance is lost to short-term priorities of the new Administration and the chemical industry, the common ground so many of us fought for and found to support last year’s historic passage of the Lautenberg Act will quickly dissipate.

The Lautenberg Act significantly overhauled and substantially improved the Toxic Substances Control Act (TSCA), the core provisions of which had never been amended since their adoption in 1976.  Among the enhancements are new provisions that:

  • mandate safety reviews for chemicals in active commerce;
  • require safety findings for new chemicals before they are allowed on the market;
  • replace TSCA’s burdensome safety standard — which prevented the Environmental Protection Agency (EPA) even from banning asbestos — with a pure, health-based safety standard;
  • explicitly require protection of vulnerable populations like children, pregnant women and workers;
  • give EPA enhanced authority to require testing of both new and existing chemicals;
  • make more information about chemicals available, by limiting companies’ ability to claim information as confidential, and by giving states and health and environmental professionals access to confidential information they need to do their jobs; and
  • retain a significant role for states in assuring chemical safety, while strengthening the federal role.

Passage of the Lautenberg Act was made possible by the coming-together of members of both parties and a broad spectrum of stakeholders around two facts:  the old law wasn’t working for anyone, and a stronger federal chemicals management system was needed to restore lost confidence among the public and in the marketplace over the safety of chemicals.

At the one-year mark, Environmental Defense Fund (EDF) remains confident that the law is strong and can and will ultimately deliver on its promises.  At the same time, its effective implementation in the near term is threatened on numerous fronts, unfolding as it is in one of the most anti-environmental and anti-regulatory climates this nation has faced in a long time.   Read More »

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