EDF Health

Selected tag(s): New chemicals

Is there no limit to industry’s overreach and hubris when it comes to new chemicals under TSCA?

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

We’ve already blogged about how changes the agency is making to its reviews of new chemicals under the Toxic Substances Control Act (TSCA) are illegal as well as bad policy.  But an industry letter and attachment added last week to EPA’s new chemicals docket shows the chemical industry isn’t done yet in seeking to eviscerate the program.

The letter and position statement were submitted to Jeffery Morris, Director of EPA’s Office of Pollution Prevention and Toxics (OPPT) by something called the TSCA New Chemicals Coalition (NCC).

They raise a multitude of red flags.

The NCC is a creation of the industry law firm Bergeson & Campbell (B&C). The letter to Morris describes NCC as “a group of representatives from over 20 companies that have come together to identify new chemical notification issues under the amended Toxic Substances Control Act (TSCA) and to work collaboratively with you and your team to address them.”

First red flag:  Nowhere are the 20+ companies identified, not in the letter or associated position statement, nor on B&C’s web pages for NCC.  Such secrecy always sets off an alarm when it comes to the chemical industry’s history of forming misleading front groups and coalitions.  Why don’t the companies want their identities known?

Second red flag:  The NCC letter and position statement claim that “OSHA has in place an extensive regulatory scheme, as well as enforcement mechanisms, governing chemical exposure in the workplace” and refers to the “robust nature of the existing OSHA regulatory program” and its “overarching and comprehensive requirements” that apply in the workplace.  Now, anyone outside of industry readily acknowledges that OSHA’s ability to adequately address workplace exposures has been decimated over time – through sustained industry efforts on many fronts, including mounting legal challenges to OSHA’s authority and successfully pressing for reduction after reduction in its budget and staffing.  Those attacks continue today, and if anything have accelerated under the Trump Administration.

Why then, you may wonder, is NCC writing to the director of EPA’s TSCA office to tout OSHA’s sweeping authority over workplace chemical exposures?  By now you may be getting a sense of where this is headed … .   Read More »

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

EDF comments at EPA’s public meeting on new chemical reviews question the credibility and legality of recent changes

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

EPA held a public meeting today to present information on major changes it is making to its review of new chemicals under last year’s reforms made to the Toxic Substances Control Act (TSCA) by the Lautenberg Act.

EPA provided brief opportunities for stakeholders to provide comments.  Two of us from EDF – I, and my colleague Robert Stockman, Senior Attorney – gave oral comments at the meeting.  We are providing those comments here in written form.

Through these actions, many clearly contrary to the law, EPA is returning the new chemicals program to its dark ages under the old TSCA, making it again into a black box within which EPA acts as if its only stakeholder is the chemical industry.

My comments are available here.

Robert Stockman’s comments are available here.

As the comments make clear, EDF believes the changes EPA is making and discussed today are both contrary to the requirements of the new TSCA and represent a retreat from the credible, transparent and accountable new chemicals program Congress sought to establish under the new law.

As I noted in my comments:  “Through these actions, many clearly contrary to the law, EPA is returning the new chemicals program to its dark ages under the old TSCA, making it again into a black box within which EPA acts as if its only stakeholder is the chemical industry.”

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

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 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

EPA’s announced changes to new chemicals review process put industry demands for ready market access above public health protection

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

Last year’s Lautenberg Act, which overhauled the badly broken Toxic Substances Control Act (TSCA), made fundamental changes intended to improve EPA’s review of new chemicals prior to their commercialization, by requiring more scrutiny of those chemicals to better ensure they are safe.  Until recently, the Environmental Protection Agency (EPA) was on track in implementing the new requirements in a health-protective manner.  With the addition of more staff, EPA was also steadily reducing the temporary backlog in new chemical reviews that had developed – a result of the fact that the law’s new requirements took effect immediately upon passage.

In recent months, however, agency staff have faced relentless pressure from the chemical industry – and internally from new industry-friendly senior management – not only to speed up reviews, but to return the program to its pre-Lautenberg practices.  There were growing signs that EPA was considering changes that would circumvent the law’s requirements in the name of increasing program “throughput.”   The agency’s press release today makes clear that this is now happening.   Read More »

Posted in Health Policy, Industry Influence, TSCA Reform / Tagged | Comments are closed

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

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.

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