Category Archives: EPA

Time to come clean: IRIS needs to require stakeholders attending its meetings to disclose their conflicts of interest

Richard Denison, Ph.D., is a Lead Senior Scientist.  Lindsay McCormick is a Research Analyst.  

EPA’s Integrated Risk Information System (IRIS) has been implementing a number of changes in the last couple of years, in response to criticism and concerns coming at it from all sides.  As stated on its website:  “These enhancements will improve productivity and scientific quality in IRIS assessments and help EPA meet the goal of producing IRIS assessments in a timely and transparent manner.”  IRIS has noted that increasing “stakeholder engagement is an essential part of the enhancements.”

Simultaneously pursuing these lofty goals of increasing throughput, scientific quality, transparency and stakeholder engagement in IRIS assessments is challenging, to say the least.  EDF has and will continue to emphasize the need to strike a balance between these goals, given that overemphasis on one can actually exacerbate the problems aimed to be addressed by another.

In this somewhat lengthy post, we’ll examine one such serious problem – skewed participation in IRIS’ bimonthly meetings.  We’ll look at steps EPA has taken to partially address the problem, and argue that the lack of adequate disclosure by participants of conflicts of interest remains a major unaddressed contributing factor.  We’ll discuss our recommendations for full disclosure and point to the strong precedents for such disclosures in other venues.   Read More »

Also posted in Health Policy, Industry Influence| Tagged , , | Comments closed

Newly listed carcinogens are all chemicals deeply embedded in US commerce

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

[CORRECTION 10/4/14:  The company identified at the bottom of the table in this post as importing pentachlorophenol has been corrected to be KMG CHEMICALS; the original post had erroneously identified the company as ALBEMARLE.]

Yesterday the National Toxicology Program (NTP) released its 13th Report on Carcinogens.  This periodic, Congressionally mandated report lists substances classified after a rigorous scientific review as either “known” or “reasonably anticipated” to be human carcinogens.

The 13th report includes 4 new listings:

  • ortho-Toluidine, used to make rubber chemicals, pesticides, and dyes, was upgraded from its prior listing as “reasonably anticipated” to now be listed as a known human carcinogen, based on studies in humans showing it causes urinary bladder cancer.
  • Three chemicals are listed for the first time, each as reasonably anticipated to be human carcinogens:
    • 1-bromopropane, used as a cleaning solvent and spray adhesive, inhalation of which has been shown in animal studies to produces tumors in the skin, lungs, and large intestine;
    • cumene, used to make phenol and acetone, inhalation of which has been shown in animal studies to produces tumors in the lungs and liver; and
    • pentachlorophenol, a wood preservative mixture, exposure to which increases risk of non-Hodgkin lymphoma in studies in humans and causes tumors in the liver and other organs in mice.

EDF used the latest available data on the production and import of industrial chemicals collected by EPA under the Toxic Substances Control Act (TSCA) to ascertain the extent to which these four chemicals are manufactured and used in the U.S.  These data demonstrate that the four substances are all present in U.S. commerce in very large amounts, considered by EPA to be high production volume (HPV) chemicals because their manufacture exceeds one million pounds annually.  In fact, all four chemicals are present in amounts far higher than that level, as shown below.  Read More »

Also posted in Health Policy, Health Science, TSCA Reform| Tagged , , | Comments closed

Report: Staggering amounts of toxic chemicals produced across America

Alissa Sasso is a Chemicals Policy FellowRichard Denison, Ph.D., is a Lead Senior Scientist.

[Cross-posted from EDFVoices blog]

Recent spills in West Virginia and North Carolina cast a spotlight on toxic hazards in our midst. But as bad as they are, these acute incidents pale in scope compared to the chronic flow of hazardous chemicals coursing through our lives each day with little notice and minimal regulation. A new report by EDF, Toxics Across America, tallies billions of pounds of chemicals in the American marketplace that are known or strongly suspected to cause increasingly common disorders, including certain cancers, developmental disabilities, and infertility.

While it’s no secret that modern society consumes huge amounts of chemicals, many of them dangerous, it is surprisingly difficult to get a handle on the actual numbers. And under current law it’s harder still to find out where and how these substances are used, though we know enough to establish that a sizeable share of them end up in one form or another in the places where we live and work.

Our new report looks at 120 chemicals that have been identified by multiple federal, state and international officials as known or suspected health hazards. Using the latest, albeit limited, data collected by the U.S. Environmental Protection Agency, we identify which of these chemicals are in commerce in the U.S.; in what amounts they are being made; which companies are producing or importing them; where they are being produced or imported; and how they are being used. An interactive online map accompanying the report lets the user access the report’s data and search by chemical, by company, by state, and by site location.

Among our findings:  Read More »

Also posted in Health Policy, TSCA Reform| Tagged , , , | Comments closed

This SNUR is not a SNORE!

Jennifer McPartland, Ph.D., is a Health Scientist.

Yesterday EPA finalized a significant new use rule (SNUR) under the Toxic Substances Control Act (TSCA) that requires manufacturers and importers of certain perfluorinated chemicals to notify EPA at least 90 days before commencing any “significant new use” of these chemicals.  (See below for what EPA has designated to be a “significant new use.”)

These notifications afford EPA an opportunity to evaluate the designated new uses before they start and address any risks the new uses may pose.  Read on to learn more about some novel aspects of this final rule, including the scope of what EPA has designated as significant new uses of these chemicals.  Read More »

Also posted in Health Policy, Regulation| Tagged , , | Comments closed

Stymied at every turn: EPA withdraws two draft TSCA proposals in the face of endless delay at OMB

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

The Environmental Protection Agency (EPA) has withdrawn two draft rules it had developed under authority of the Toxic Substances Control Act (TSCA).  EPA originally sent the proposed rules to the White House for its review way back in 2010 and 2011. 

Despite a clear requirement that White House reviews of draft proposed rules be completed within 90 days, the Office of Information and Regulatory Affairs (OIRA) [which is part of the Office of Management and Budget, OMB] sat on these two draft proposals for 1,213 and 619 days, respectively.  Faced presumably with the reality that OIRA was never going to let EPA even propose the rules for public comment, EPA decided to withdraw them.  Read More »

Also posted in Health Policy, Regulation| Tagged , , , | Comments closed

EDF comments at EPA workshop on applying systematic review methodology to IRIS assessments

Rachel Shaffer is a research assistant.

Lately, much of the attention of the environmental health community has been focused on Capitol Hill and the Lautenberg-Vitter chemical safety reform bill that would amend the antiquated Toxic Substances Control Act (TSCA). Yet significant – if somewhat esoteric – developments are underway at EPA that will also have major impacts on how the safety of chemicals is assessed.  EPA has been implementing improvements to its Integrated Risk Information System, commonly known as “IRIS.” The purpose of the IRIS program is to evaluate information on the effects of potential exposures to environmental substances and provide health hazard assessments, which are then used to support regulatory decisions across the agency.  And while it isn’t directly affected by TSCA or its reform, IRIS provides both indirect and direct support to the office at EPA that does administer TSCA.  

In other words, what happens in IRIS doesn’t stay in IRIS.

So… what’s IRIS up to? Read More »

Also posted in Health Policy, Health Science| Tagged , , , , | Comments closed
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