EDF Health

Next TSCA chemical peer reviews and draft risk evaluations to be delayed. You’ll never guess why.

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

We’re hearing that EPA has cancelled the next meeting of its Scientific Advisory Committee on Chemicals (SACC), which was scheduled for October 21-25.  The SACC is conducting peer reviews of EPA’s draft risk evaluations of the first 10 chemicals to undergo safety reviews under the Toxic Substances Control Act (TSCA).

Word is that the panel was to use its October meeting to peer-review the draft risk evaluations for methylene chloride and N-methylpyrrolidone (NMP).  But release of those drafts has been delayed, leaving insufficient time for the SACC to review them before the meeting.

We’re also hearing why release of the drafts has fallen behind.  The drafts were on track for release late last month, but apparently were blocked based on objections about at least the draft risk evaluation for methylene chloride.  The objections were lodged by Dr. Nancy Beck.  Read More »

Also posted in EPA, Health Policy, Health Science, TSCA Reform / Tagged , | Read 1 Response

No, Bergeson & Campbell, the public’s right to know about new chemicals is not a distraction or waste of resources

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

Earlier this month, EDF and other NGOs filed a notice of intent (NOI) to sue the Environmental Protection Agency for violations of the Toxic Substances Control Act and its own regulations that deny the public timely access to information on chemicals companies seek to bring onto the market.

Members of the public have a right to know about chemicals entering the market because they may well be exposed to them.  And they have a right to know about and meaningfully participate in EPA’s review of the safety of those chemicals because such transparency, accountability, and public participation are fundamental to good government, as well as being required by the law.

This week the industry law firm Bergeson & Campbell (B&C) offered a commentary on the NOI, lamenting it as “hugely distracting and draw[ing] resources and [EPA] management’s attention away from other priorities.”  Note that B&C represents many companies that submit new chemicals to EPA for review under TSCA and has been a central actor in the chemical industry’s efforts to weaken those reviews.

In its commentary, B&C acknowledges that the NOI has identified real legal violations committed by EPA, and that these violations result in the public having less information about the agency’s new chemicals program.  But B&C asserts that the violations don’t really matter because they have been going on for a long time, not just under this administration.  While that is true in some cases, the argument ignores the two elephants in the room.  Read More »

Also posted in EPA, Health Policy, Regulation, TSCA Reform / Tagged | Comments are closed

EPA’s latest move to deflect criticism of its TSCA risk evaluations: Muzzle its science advisors

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

Readers of this blog know that Environmental Defense Fund (EDF) has voiced strong opposition to a number of decisions made by the Environmental Protection Agency (EPA) that aim to limit the risks it finds when evaluating the safety of chemicals under the Toxic Substances Control Act (TSCA).

These decisions include:

  • excluding from its analysis known human and environmental exposures to a chemical, based on unwarranted assumptions that those exposures are adequately managed by other statutes;
  • claiming without support that workers are protected by assuming universal and universally effective use of personal protective equipment throughout chemical supply chains and the adequacy of OSHA regulations that either don’t apply or are decades out of date;
  • arbitrarily loosening EPA’s longstanding risk standards governing when cancer incidences are deemed unacceptably high; and
  • choosing not to exercise its enhanced authorities under TSCA to require submission of robust information on chemicals’ hazard and exposures, resorting instead to questionable assumptions and relying on voluntarily submitted industry data that are unrepresentative or of poor or indeterminate quality.

Through these decisions, EPA increases the likelihood that it will either not find unreasonable risk and thereby avoid regulating the chemical, or if that can’t be accomplished, find risks that are low enough that it can impose few restrictions, thereby burdening industry as little as possible.

In response to each of these decisions, EPA has received dozens of highly critical comments on its draft risk evaluations from state and local governments, labor and health groups, environmental NGOs and members of the scientific community.  And in the first several peer reviews conducted by its Scientific Advisory Committee on Chemicals (SACC), many of the scientists voiced quite similar concerns during the committee’s public meetings (as of yet, final peer review reports have not been issued).

Rather than address the problems, EPA has adopted a new tactic to stifle the criticism, one that is quite chilling (literally and figuratively):  It is telling the SACC that these issues are off-limits to the peer reviewers because they represent policy decisions that are beyond the charge given to the SACC.  This is beyond the pale, for several reasons.  Read More »

Also posted in EPA, Health Policy, Health Science, Regulation, TSCA Reform / Tagged , | Comments are closed

EPA needs to stop misleading the public and its peer reviewers about the data it has obtained from the European Chemicals Agency

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

In numerous assessment documents issued by the Environmental Protection Agency (EPA) developed in its implementation of the Toxic Substances Control Act (TSCA), EPA cites as a source the European Chemicals Agency (ECHA).  ECHA is the agency that administers the European Union’s (EU) REACH Regulation, which (unlike TSCA) requires the registration of chemicals in commerce by companies that wish to continue to produce and use the chemicals in the EU.

When companies register chemicals under REACH, they are required to develop and submit a “dossier” of certain information on production and use as well as on physical-chemical properties, fate, hazard, exposures and risks.  ECHA then makes information available on its website.

In its draft risk evaluations for the first 10 chemicals undergoing evaluations under TSCA, as well as in some of its support documents for high-priority substance designations under TSCA, EPA has heavily relied on these dossiers.  But in doing so, EPA has grossly mischaracterized the source and nature of the data it references as coming from ECHA.

EDF has been raising concerns about EPA’s mischaracterizations for some time now (see section 1.E of our comments on EPA’s draft risk evaluation for 1,4-dioxane), but they persist.  And as recently as yesterday, members of the peer review panel reviewing EPA’s draft documents have been led by EPA statements and citations to assume a degree of completeness and government review of these data that is simply false.

EPA needs to immediately cease and desist in its mischaracterizations.  Read More »

Also posted in EPA, Health Policy, Health Science, Regulation / Tagged , | Comments are closed

1,4-dioxane: The case of the disappearing tumors

Rachel Shaffer is a consultant.  Richard Denison, Ph.D.is a Lead Senior Scientist.

As we highlighted in a previous post, EDF filed extensive comments on EPA’s draft risk evaluation for 1,4-dioxane. Among the many concerns we raised was a decision by the Trump EPA to completely dismiss female mouse liver cancer data used by EPA’s Integrated Risk Information System (IRIS) program as key inputs to its cancer risk modeling conducted in 2013. The Agency appears to be trying every trick in the trade – such as excluding most exposure sources and routes – in its effort to conclude that the chemical presents few or no risks to human health or the environment. Read on for more on this latest one. Read More »

Also posted in EPA, Health Policy, Health Science, Regulation / Tagged | Comments are closed

Should EPA grant industry’s hypocritical request to now address 1,4-dioxane’s risks as a byproduct, it must meet a number of conditions

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

Environmental Defense Fund (EDF) submitted extensive comments last week to the Environmental Protection Agency (EPA) that raise numerous serious concerns with EPA’s draft risk evaluation for the likely human carcinogen 1,4-dioxane.  EDF’s comments are available here.

I want to use this post to highlight one of the many issues:  For years, the industry has urged EPA not to include 1,4-dioxane’s presence as a byproduct in various formulated products within the scope of its risk evaluation for the chemical; see comments specific to 1,4-dioxane from the American Cleaning Institute, Procter & Gamble, and the Household & Commercial Products Association; and more general comments urging exclusions for byproducts and “trace levels” from the American Chemistry Council and the Consumer Specialty Products Association Comment.

Not surprisingly, the Trump EPA’s draft risk evaluation for 1,4-dioxane did just that, a major problem EDF objected to on legal and scientific grounds.

Then in late July, the industry abruptly reversed itself.  A comment letter submitted to EPA by the American Cleaning Institute and the Grocery Manufacturers Association says the industry has changed its mind and is now calling on EPA to include 1,4-dioxane’s presence as a byproduct as a condition of use in its risk evaluation.

Why the shift?  At this late hour it has dawned on the industry groups that any final action by the agency on the chemical that excludes 1,4-dioxane’s presence as a byproduct as a condition of use in its risk evaluation will not preempt states from acting to regulate this condition of use.

The industry’s hypocrisy aside, if EPA decides to grant this industry request, which has arrived long after EPA initiated the risk evaluation process, EPA should do so only subject to conditions that are critical to meet if its decision and risk evaluation are to maintain any semblance of credibility:

  • EPA needs to use its mandatory information authorities to require the submission and development of relevant information on the presence of 1,4-dioxane as a byproduct in industrial, commercial and consumer materials and products, as input into a revised draft risk evaluation.
  • EPA must promptly make all such information it receives public, subject only to redactions of information claimed confidential by the submitters that EPA determines meet all applicable requirements of TSCA section 14. It should be noted that much of the relevant information will constitute health and safety information that is not eligible for protection under section 14 and must be made public.
  • EPA needs to carefully and thoroughly develop and fully integrate an analysis of the potential exposures and risks arising from the presence of 1,4-dioxane as a byproduct into all aspects of its risk evaluation, given that inclusion of the presence of 1,4-dioxane as a byproduct will affect all of the exposure and risk estimates EPA has examined in the current draft risk evaluation.
  • EPA must publish a revised draft risk evaluation for public comment, providing the public with ample time to review the new draft and develop meaningful comments.
  • EPA must subject its revised draft risk evaluation to full peer review by the Scientific Advisory Committee on Chemicals (SACC), providing the committee with ample time to review the new draft and develop meaningful comments.

Any credible evaluation of the contribution to 1,4-dioxane’s overall health and environmental risks due to its presence as a byproduct must be based on complete, reliable information that is publicly accessible, and must reflect input from both the public and expert peer reviewers.  For EPA to do anything less will simply cast yet more doubt on its trustworthiness and independence from industry interests.

 

Also posted in EPA, Health Policy, Health Science, Regulation / Tagged , | Comments are closed