EDF Health

EDF comments fault EPA for deviating from the law in proposal for states and health professionals’ CBI access

By / Published: April 17, 2018

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

One of the key reforms to the Toxic Substances Control Act (TSCA) made by 2016’s Lautenberg Act was the expansion of who can access confidential business information (CBI) submitted by companies to EPA.  The old law largely limited access to federal government employees and contractors.  Congress recognized the enormous value such information could provide to officials at other levels of government and to health providers and environmental officials treating or responding to chemical releases and exposures.  It therefore mandated that EPA expand CBI access, subject to certain conditions specified in the law.

In March, a full 21 months after passage of the Lautenberg Act, EPA finally issued draft guidance documents setting forth how it intends to meet the law’s mandate to expand access to CBI.  Unfortunately, as has been the case with so many other aspects of TSCA implementation under the Trump administration, EPA got a lot of things wrong in its draft guidance documents.

Yesterday, EDF filed extensive comments raising our concerns over these serious deviations from the law and providing our recommendations for fixing them.   Read More »

Posted in Health policy, Public health, TSCA reform / Tagged , , | Comments are closed

EPA IRIS program receives high marks from the National Academies

By Jennifer McPartland / Published: April 16, 2018

Jennifer McPartland, Ph.D., is a Senior Scientist and Ryan O’Connell is a High Meadows Fellow with the Health Program.

Last week the National Academy of Sciences (NAS) published its review of the Environmental Protection Agency’s (EPA) Integrated Risk Information System (IRIS) program, concluding that the program has made strong progress in implementing NAS’ earlier recommendations. As noted by the chair of the NAS committee that led the review, “The changes in the IRIS program over such a short period of time are impressive.”

As I’ve blogged about before, IRIS is a non-regulatory program that provides critical chemical reviews and scientific expertise that help ensure the water we drink, the air we breathe, and the land where we live, work, and play are safe. Offices across EPA and elsewhere in the federal government rely on IRIS, as do states, local governments, and affected communities (see here and here).[pullquote]“The changes in the IRIS program over such a short period of time are impressive.”[/pullquote]

The new NAS report comes four years after its 2014 review, which noted the substantial progress made by IRIS in addressing recommendations from a more critical 2011 review of a draft IRIS assessment of formaldehyde. It is worth noting that half of the committee members involved in the new IRIS review served on the committee that authored the 2011 review.   Read More »

Posted in Health science / Tagged , , | Comments are closed

Monitoring our chemical exposures: Five lessons learned and what’s on the horizon

By Lindsay McCormick / Published: April 12, 2018

Lindsay McCormick, is a Project Manager.

Last October, a groundbreaking report concluded that diseases caused by pollution were responsible for 1 in 6 premature deaths in 2015 worldwide.  That’s 9 million deaths caused by environmental pollution – three times more than AIDS, tuberculosis, and malaria combined.

That may seem startling at first, but health outcomes are largely defined by a person’s genes and their environment.  In fact, environmental factors – like ambient and household air pollution, industrial chemicals, and common consumer products – are implicated in health impacts ranging from cancer and asthma to infertility.

Unfortunately, our ability to track an individual’s chemical exposures – also called the “chemical exposome” – lags way behind what we can measure genetically.  And without this information, it is virtually impossible to develop sound policies and evidence-based interventions to reduce harmful exposures and protect health.

But what if everyone could monitor hazardous chemical exposures? What if school children, soldiers, pregnant women, flight attendants, nail salon workers, gas attendants, and those living within just a few miles of industrial sites – or just about anyone – could understand chemical exposures in their personal environment?

This is where EDF comes in. EDF is exploring ways to catalyze development and scaling of breakthrough technologies capable of detecting an individual’s exposure to a broad spectrum of chemicals—making the invisible, visible.

Our efforts began three years ago, with a series of pilot projects in which people wore a simple silicone wristband capable of detecting over 1,400 chemicals in the environment. Today, we’re collaborating with diverse stakeholders to identify needs and opportunities for accelerating broad uptake of chemical exposure monitoring technologies. Below are five important lessons to jump-start this opportunity. Read More »

Posted in Chemical exposure, Emerging science, Emerging testing methods / Tagged | Authors: / Comments are closed

Heavy metals in food: Carrageenan as an example of the need to improve ingredient quality

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: April 6, 2018

Tom Neltner, J.D., Chemicals Policy Director, and Maricel Maffini, Ph.D., Independent Consultant.

[pullquote]

Arsenic, cadmium and lead levels in carrageenan varied widely but were within international standards. This is not reassuring since current specifications for the heavy metals are inadequate. Food manufacturers can and should set tighter limits to better protect their customers. Consumers, especially those buying from internet-only retailers, need to ask the ingredient supplier how much of the heavy metals is acceptable.

[/pullquote]

In the fall of 2013, the Food and Drug Administration (FDA) bought 10 samples of carrageenan from 5 companies sold through internet-only retailers to test for three heavy metals – lead, arsenic (total and inorganic), and cadmium. The agency published the results on its combination metals testing webpage in September 2016.

Each of these metals are carcinogens. In addition, lead and inorganic arsenic are widely acknowledged as harming children’s brain development even at low levels of exposure. EDF found that more than one million children consume lead in amounts that exceeds the maximum exposure level set by FDA in 1993, a level that subsequent research shows is of great risk to children’s health. Further, recent research has strengthened evidence of the relationship between low levels of lead exposure in adults and cardiovascular deaths. In 2011, the Joint FAO/WHO Expert Committee on Food Additives (JECFA) took the extraordinary step of withdrawing its previous tolerable intake level for lead because it could not determine a safe level of exposure for children.

In light of these risks, we must make every effort to reduce the levels of these heavy metals in food to the greatest extent possible – without undermining other food safety measures or compromising quality. A key step to success is examining the levels of heavy metals in all ingredients used to make a food since the risk is based on the cumulative exposure – even if the amounts in individual additives are small. With this in mind, we revisited FDA’s analysis of carrageenan.

Read More »

Posted in FDA, Food, Health policy, International, Regulation / Tagged , , , , , , , , | Comments are closed

Pruitt’s EPA plans to systematically deconstruct the expanded authority a bipartisan Congress gave it less than two years ago

By / Published: April 3, 2018

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

EDF has learned from sources across the Environmental Protection Agency (EPA) that its political appointees are taking steps to systematically dismantle the agency’s ability to conduct broad risk reviews of chemicals and effectively address identified risks under the Toxic Substances Control Act (TSCA).

The assault is taking the form of methodically excising from the scopes of the agency’s chemical reviews any uses of, or exposures to, chemicals that fall under TSCA’s jurisdiction, if those uses or exposures also touch on the jurisdiction of another office at EPA or another Federal agency.[pullquote]The Pruitt EPA’s attempt to atomize the evaluation of chemical risks has one purpose:  to make it far less likely that risks needing to be controlled will be identified.  If each activity that leads to a chemical exposure is looked at in isolation, it will be far more likely that such activity will be deemed safe.[/pullquote]

Under the Lautenberg Act’s 2016 amendments to TSCA, Congress directed EPA to identify the first 10 chemicals to undergo risk evaluations; EPA did so in December 2016.  After the transition to the new Administration, EPA scrambled to produce documents that set forth the “scopes” of those evaluations in order to meet the law’s deadline of June 2017; EPA acknowledged, however, that its scope documents were rushed and incomplete, and promised to update them in the form of so-called “problem formulations” that would be issued within six months.  Those documents are now months late.

We now are learning why:  Political appointees at EPA are engaged in an intra-agency process intended to dramatically narrow the scopes of those first 10 reviews.  They are seeking to shed from those reviews any use of or exposure to a chemical that touches on another office’s jurisdiction, apparently regardless of whether or what action has been or can or will be taken by that office to identify, assess or address the relevant potential risks of that chemical.  Reports indicate that leadership in some offices are welcoming this move, while others are resisting it.   Read More »

Posted in Health policy, Health science, Industry influence, TSCA reform / Tagged , | Comments are closed

EPA is keeping the public in the dark on premanufacture notices for new chemicals under TSCA

By / Published: April 2, 2018

Stephanie Schwarz, J.D., is a Legal Fellow.  Richard Denison, Ph.D., is a Lead Senior Scientist.

Part 1               Part 2               Part 3               Part 4

This is the third in a series of blog posts based on our frustrating, and frustrated, efforts to get information on premanufacture notifications (PMNs) for new chemicals under the Toxic Substances Control Act (TSCA).  The saga began when we requested from the EPA Docket Center the public files on 69 new chemicals, most of which EPA had determined were “not likely to present an unreasonable risk” under the TSCA, as amended in 2016 by the Lautenberg Act.  This series of posts analyzes and describes what we did, and did not, get from the Docket Center, to which EPA staff pointed us when we raised the fact that such files are not available on EPA’s website or at www.regulations.gov, despite EPA regulations requiring they be.

TSCA and EPA’s regulations contain a number of provisions that, if reliably implemented, would give the public better access to, or at least a better understanding of, the information EPA receives on new chemicals.  This includes mandates that EPA:

  • publish in the Federal Register EPA’s receipt of new chemical PMNs (TSCA § 5(d)(2));
  • make all PMNs and Significant New Use Notices (SNUNs) publicly available (TSCA § 5(d)(1));
  • make all information submitted with the notices available to the public (TSCA § 5(b)(3) and 40 C.F.R. § 720.95); and
  • make the public files electronically available (40 C.F.R. §§ 700.17(b)(1), 720.95).

EPA has repeatedly committed to increasing the transparency of its new chemicals program.  Unfortunately, our review of the PMN files we received has revealed massive gaps and inconsistencies in the information EPA does provide to the public, and all too often we are finding that EPA has entirely failed to comply with the law and its own regulations.  These failings are on top of efforts by the agency to actively hide information on new chemicals that it had made public for decades.

This post will focus on failings of EPA’s new chemicals program when it comes to transparency and compliance with TSCA and its own regulations with respect to the PMNs EPA receives for new chemicals.  These failings make it virtually impossible for the public to gain any understanding of, or play any meaningful role in, EPA’s review of new chemicals under TSCA.   Read More »

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