EDF Health

NGOs ask Senators to investigate chronic delays in OMB’s review of TSCA regulatory actions

By Rachel Shaffer / Published: September 10, 2013

Rachel Shaffer is a research assistant.  Richard Denison, Ph.D., is a Senior Scientist.

Last Friday afternoon, we received the discouraging news that EPA has withdrawn two draft rules it had developed under its Toxic Substances Control Act (TSCA) authority.  As discussed in our earlier blog post, these proposed rules had been kept in limbo by the Office of Information and Regulatory Affairs (OIRA), within the Office of Management and Budget (OMB), for 1,213 and 619 days, respectively – far longer than the 90-day limit for such reviews set by Executive Order 12866.

Unfortunately, these delays are anything but unique.  OIRA’s reviews of draft rules and other actions now routinely exceed by large margins their mandated deadlines.  Our examination of EPA’s TSCA regulatory agenda over the past several years reveals just how extensive OIRA’s “rulemaking purgatory” has become.  

Since 2009, a total of 33 TSCA-related notices or proposed or final regulatory actions have been submitted to OIRA:

  • Eighteen submissions were proposed or final rules subject to a 90-calendar-day deadline.  Reviews of only six of these rules were completed within this deadline; on average, they have been held at OIRA for over 300 days.
  • The other 15 were advance notices of proposed rulemakings or other notices subject to a 10-working-day deadline.  Of these notices, only one was completed within this deadline; on average, they were kept under review by OIRA for over 70 working days.

Today, EDF, Earthjustice, Union of Concerned Scientists, and League of Conservation Voters sent a letter documenting these delays and expressing our serious concerns to Senator Richard Blumenthal (D-CT) and Senator Orrin Hatch (R-UT), Chairman and Ranking Member, respectively, of the Senate Judiciary Committee’s Subcommittee on Oversight, Federal Rights, and Agency Action.  Our letter emphasized that such delays both prevent the public from providing input in the rulemaking process and limit EPA’s already constrained ability to obtain and share basic safety information on chemicals under TSCA.

Our letter was sent in response to an August 1, 2013, hearing held by that subcommittee, titled Justice Delayed: The Human Cost of Regulatory Paralysis, which began a much-needed discussion of the real-world impact of OIRA’s protracted review of proposed regulations.  We urged a further investigation into the causes and consequences of this too-hidden obstruction of the long-established rulemaking process. 

You can read our letter here, and stay tuned for updates in the coming months.

 

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

By Rachel Shaffer / Published: August 27, 2013

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 »

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My mother is not Angelina Jolie

By Rachel Shaffer / Published: May 21, 2013

Rachel Shaffer is a research assistant.

Last week, Angelina Jolie announced that she recently had a double mastectomy: surgery to remove both of her breasts. She chose to undergo such a difficult procedure because she, like her mother who had breast cancer (and died of ovarian cancer), carries the BRCA1 gene, a genetic mutation that significantly raises her risk of breast and ovarian cancer. While Jolie does not have cancer, this surgery lowers her chances of developing the disease in the future.

That otherwise healthy women are choosing to take such drastic steps to reduce their risks of cancer demonstrates a willingness to make profound sacrifices for health.  But it also raises the question of what options for prevention are available to the millions of other women who develop breast cancer, even though they have no known genetic risk factor. Approximately 90-95% of breast cancer cases cannot be attributed to BRCA1 or other genetic mutations; these cases are triggered by various factors in a woman’s environment.  

My mother’s cancer, diagnosed ten years ago this month, falls into this category. So once again, I’m reminded of the obvious: the life of superstar Angelina Jolie does not reflect the life of my mother or the lives of the vast majority of women.  Read More »

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April brings showers…and a flurry of new studies on the risks of perfluorinated chemicals

By Rachel Shaffer / Published: April 30, 2013

Rachel Shaffer is a research assistant.

What do waterproof jackets, car wax, and non-stick pans have in common?

Aside from being great Father’s Day presents (Dad, I’m thinking ahead this year!), they also all are made with perfluorinated compounds, or PFCs. There are hundreds of different PFCs, and their oil- and water-resistant properties make them useful in a variety of products, from cookware and carpets to food-packaging and electronics.  

Unfortunately, these chemicals have less desirable properties as well. Thanks to their strong molecular bonds, PFCs do not readily break down; they persist in the environment and in our bodies. And, widespread use has led to extensive human exposure. The Centers for Disease Control’s (CDC) human biomonitoring program, the National Health and Nutrition Examination Survey (NHANES), detected four types of PFCs in over 98% of samples representative of the U.S. population collected in 2003-2004.  

Two of the compounds detected in NHANES, perfluorooctane sulfonic acid (PFOS) and perfluorootanoic acid (PFOA), are the focus of three new studies published this month in Environmental Health Perspectives. These studies, one reporting an association with osteoarthritis in women, another an association with semen quality in men, and a third an association with asthma in children, add to a growing concern about the potential adverse effects of these ubiquitous chemicals.

What follows is a brief overview of the findings of these new studies.  Read More »

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“Toxic Clout” shines a much-needed light on the chemical industry’s undue influence over toxic chemical decisions

By Rachel Shaffer / Published: March 25, 2013

Rachel Shaffer is a research assistant.

Remember the 2000 hit film, Erin Brockovich?  It was the Hollywood version of a real-life investigation into the contamination of groundwater in Hinkley, California with a known human carcinogen called hexavalent chromium (or hexchrome for short).  

Well, hexchrome is back on (a slightly smaller) screen, this time featured in a two-part series by the Center for Public Integrity (CPI) and PBS NewsHour.

The series, which aired on public TV stations earlier this month, highlights the continuing problem of hexchrome contamination around the country, including the still-unresolved situation in Hinkley.  Some 70 million Americans are exposed to this carcinogen through the water they drink. 

But the program also dives into another, even more concerning problem:  Years of delay in finalizing EPA’s risk assessment for the toxic metal, a prerequisite to any effective regulation.  Why the delay? Unfortunately, it’s an all-too-familiar story:  the chemical industry is stalling the process.  

And what are the consequences?  As EDF’s Senior Scientist Dr. Richard Denison says in the series:  “Decisions delayed are health protections denied.”  The chromium standard for drinking water has not been updated since 1991 and does not reflect recent scientific findings indicating that the standard needs to be significantly lowered to protect public health.

Check out the CPI/PBS segments (links below) and the related articles in CPI’s Toxic Clout series, which is part of an ongoing investigation of excessive industry influence in science and policy.

                Part 1: Science for Sale

                Part 2: Decision Delayed on Dangerous Chemical in Drinking Water

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21st Century on the horizon for endocrine disruptor screening?

By Rachel Shaffer / Published: January 31, 2013

Rachel Shaffer is a research assistant. Jennifer McPartland, Ph.D., is a Health Scientist.

BPA, DDT, PCBs, PBDEs, phthalates, PFOA … Forgive the alphabet soup, but chances are you’ve heard of at least some of these endocrine-disrupting chemicals (EDCs), which have been the subject of a lot of public and media attention in the last several years. Research has begun to uncover the ways in which these chemicals can interact with the body’s hormone – or endocrine – system to disrupt various natural biological processes, including metabolism, the reproductive system, and development of the brain and nervous systems.

While the endocrine-disrupting properties of the chemicals named above have been confirmed, scientists suspect there may be many more such chemicals in our environment, in the products we use, and in our bodies.  How can we identify them?

Legislation enacted in 1996 required the U.S. Environmental Protection Agency (EPA) to develop a screening program to identify potential EDCs.  More than 10 years later, EPA finally launched the Endocrine Disruptor Screening Program (EDSP).  Testing is being conducted in two phases, or “tiers.”  In “Tier 1,” a screening battery of validated in vivo and in vitro assays is used to identify chemicals with potential to interfere with the endocrine system. Chemicals flagged in the first tier of testing are then subject to “Tier 2” testing intended to determine the specific effect and the lowest dose at which it occurs. (We should note this program is very controversial and the subject of ongoing debate, but that is not the subject of this post.)

EPA has identified an estimated 9,700 chemicals to be screened – a very daunting task given the time- and resource-intensive nature of the testing battery EPA has established.  Might there be a way to expedite the identification and testing of the more problematic chemicals? A study published earlier this year in Environmental Health Perspectives (EHP) investigates a possible approach: using in vitro high-throughput (HT) assays developed through EPA’s ToxCast and Tox21 programs to target and prioritize chemicals for further testing under the EDSP. While use of these assays poses its own challenges, might it at least help in determining an appropriate testing sequence?  Read More »

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