Author Archives: Rachel Shaffer

A gift for mothers (and daughters, and all of us): New tools for breast cancer monitoring and prevention

Rachel Shaffer is a research assistant.

Our mothers are no doubt on our minds right now, after Mother’s Day weekend. And I am no exception, especially since, as I blogged about last year, this month is the anniversary of my own mother’s breast cancer diagnosis.

This year though, in addition to celebrating my mother’s recovery, I can find hope in a new report from researchers at the Silent Spring Institute that provides guidance to improve our ability to screen for and study potential breast carcinogens — thereby enhancing efforts to prevent this widespread disease. Good news, certainly… and a timely gift for all of the women in our lives.

This new report describes biomonitoring methods for 102 breast carcinogens with high exposure potential and identifies existing cohort studies into which these methods could be integrated immediately. These chemicals are among the 216 previously identified by the authors as chemicals linked to mammary gland tumors in rodents. By testing for exposure markers of these priority breast carcinogens in the population, researchers should be able to better identify and study high-risk groups, and regulators will be better able both to limit dangerous exposures and to demonstrate the public health benefits of these exposure reductions.

The full report is available online, but I want to highlight a few key themes that are particularly relevant to current scientific and political debates.  Read More »

Posted in Emerging Testing Methods, Health Policy, Health Science, TSCA Reform| Tagged , | Comments closed

Unnerving developments in the state of the evidence on developmental neurotoxicity

Rachel Shaffer is a research assistant.

Seven years ago, leading children’s environmental health experts Philippe Grandjean and Philip Landrigan published a groundbreaking review that identified five chemicals prevalent in the environment—lead, methylmercury, polychlorinated biphenyls (PCBs), arsenic, and toluene—as developmental neurotoxicants. In their follow-up review released last week, they have added six more chemicals—manganese, fluoride, polybrominated diphenyl ethers (PBDEs), chlorpyrifos, DDT, and tetrachloroethylene (PERC)—to this list. The implications of early-life exposures to these common compounds, say the authors?  A “global silent pandemic of neurodevelopmental toxicity.”  Read More »

Posted in Emerging Science, Health Policy, Health Science| Tagged , , , , , | Comments closed

Maybe not surprising, but still upsetting: New report highlights role of election-year politics in OIRA delays

Rachel Shaffer is a research assistant.

Earlier this month, the Administrative Conference of the United States (ACUS) completed an investigation into the Office of Information and Regulatory Affairs’ (OIRA) long delays in reviewing proposed and final rules and to offer recommendations for improving the efficiency and transparency of OIRA’s review process. The final report – which was featured in a front page story in the Washington Post – echoes and expands upon concerns we discussed in a previous blog post and a joint letter sent to Senator Blumenthal’s office earlier this year.

ACUS documents that the average time for OIRA reviews has significantly increased in recent years. From 1994-2011, the average review time was 50 days. However, in 2012, the average review time rose to 79 days. And in the first part of 2013, the average review time rose further to 140 days

The reason for these growing delays?  Read More »

Posted in Health Policy, Regulation| Tagged , , , | Comments closed

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

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.

 

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 »

Posted in EPA, Health Policy, Health Science| Tagged , , , , | Comments closed

My mother is not Angelina Jolie

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 »

Posted in Health Policy, Health Science| Tagged , , | Comments closed
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