EDF Health

Nothing is forever – and chemical industry trade secret claims shouldn’t be an exception

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

A coalition of health, labor, environmental and environmental justice groups (including EDF), represented by Earthjustice, filed a petition today with the Environmental Protection Agency (EPA) that requests EPA establish a limit on how long information on chemicals submitted and claimed confidential by the chemical industry under the Toxic Substances Control Act (TSCA) can be protected from disclosure.

The petition asks EPA to close a loophole in its current regulations that by default grants indefinite protection for nearly all chemical information claimed confidential.  Because EPA’s only option under its current regulations is to challenge these claims on a case-by-case basis, industry bears no responsibility to ensure that its claims remain valid over time.  The lack of any expiration date for such claims has contributed to a large backlog of excessive and often unwarranted claims – the protection of which imposes large costs on EPA and the American taxpayer and denies public and market access to information that could lead to better-informed decisions about chemicals.

The petition filed today offers a simple solution, one called for in virtually every internal and external review of EPA trade secret policy conducted over the last several decades (see list at the end of this post):  EPA should alter its regulations to create a “sunset” for confidential business information (CBI) claims, which would expire after a set period of time (5 years is proposed) unless the claimant shows that continued protection is warranted.  This approach would allow true trade secrets to continue to be protected while providing public access to information that no longer warrants trade secret protection.  Read More »

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Twice in 2 weeks: National Academy of Sciences again strongly affirms federal government’s science, agrees formaldehyde is a known human carcinogen

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

Just last week I blogged that a panel of the National Academy of Sciences (NAS) had fully backed the National Toxicology Program’s (NTP) listing of styrene as “reasonably anticipated to be a human carcinogen.”

Today a separate NAS panel strongly endorsed NTP’s listing of formaldehyde as a “known human carcinogen” in its 12th Report on Carcinogens (RoC).  As with styrene, this second NAS panel both peer-reviewed the RoC listing and conducted its own independent review of the formaldehyde literature – and in both cases found strong evidence to support NTP’s listing.  See the NAS press release here, which links to the full report.  Read More »

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National Academy of Sciences strongly affirms science showing styrene is a human carcinogen

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

It’s been a ridiculously long road to get here, because of the delay tactics of the chemical industry.  But yesterday a panel of the National Academy of Sciences (NAS) fully backed the National Toxicology Program’s (NTP) listing of styrene as “reasonably anticipated to be a human carcinogen.”

We have blogged earlier about this saga.  In June 2011, after years of delay, the NTP released its Congressionally mandated 12th Report on Carcinogens (RoC), in which it upgraded formaldehyde to the status of “known to be a human carcinogen,” and for the first time listed styrene as “reasonably anticipated to be a human carcinogen.”  The chemical industry launched an all-out war to defend two of its biggest cash cows, filing a lawsuit to try to reverse the styrene listing (which it lost), and seeking to cut off funding for the RoC.  

In late 2011, the industry managed to get its allies in Congress to slip into the Consolidated Appropriations Act of 2012, without any debate, a rider that mandated NAS to review the styrene and formaldehyde listings in the 12th RoC.  Yesterday’s NAS report on styrene is the first installment, with the second one on formaldehyde expected shortly.

The NAS report could not be more supportive of the NTP’s listing of styrene, finding “that ‘compelling evidence’ exists in human, animal, and mechanistic studies to support listing styrene, at a minimum, as reasonably anticipated to be a human carcinogen.” (emphasis added)  Read More »

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New bill puts BPA back in the spotlight

Sarah Vogel, Ph.D., is Director of EDF’s Health Program.

The hotly debated chemical BPA is back in the policy spotlight. This week Senator Edward Markey (D-Mass) joined Representatives Lois Capps (D-CA) and Grace Meng (D-NY) to announce the Ban Poisonous Additives (BPA) Act.  The bill would ban the use of BPA or bisphenol A from food packaging and mandates extensive consideration of the hazardous properties of any BPA alternative, so as to avoid substituting chemicals that may pose just as many health risks (as increasingly it appears to be with the case of the common BPA replacement, BPS).

Low dose exposure to BPA has been associated with a wide range of health effects including behavioral problems, prostate, breast and liver cancer as well as obesity.  A study released just last week demonstrated how low dose exposure to BPA during fetal development can alter gene expression in the mammary gland of female rats, resulting in abnormal development of the breast and increased susceptibility to breast cancer later in life.   Read More »

Posted in Health policy, Health science, Regulation / Tagged | Read 1 Response

EPA releases final risk assessment for TCE: One down, 84,999 to go*

Richard Denison, Ph.D., is a Lead Senior Scientist.  Jennifer McPartland, Ph.D., is a Health Scientist.

EPA achieved a rather significant milestone today in releasing a final risk assessment for the solvent trichloroethylene (TCE).  This document is for the first of a group of 83 “work plan chemicals” EPA identified in 2012 as needing risk assessments and, where warranted, risk management.

Why do we call it a milestone?  It is the first final risk assessment issued by EPA using its authority under the Toxic Substances Control Act (TSCA) in – wait for it – 28 years.

The last time EPA issued a final risk assessment for a chemical under TSCA was in 1986, for asbestos.  (EPA has developed a few draft assessments under TSCA over the years, but today marks the first time since 1986 that one of them has been finalized.)

So, kudos to EPA for finally getting this risk assessment to the finish line.  Now what’s next?  Read More »

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

Imbalanced act: An EPA IRIS agenda that speaks 1000 words

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

[UPDATE 6/24/14:  Perhaps in response to this post of last week, an updated agenda for this week’s IRIS meeting was posted by EPA today that reflects a somewhat more balanced set of speakers.  Industry interests appear to have consolidated their number of slots, down from a high of 8 to a high of 6 per issue, and down from a high of 6 to a high of 4 individuals per issue from the same consulting firm.  In addition, several additional slots are assigned to non-industry speakers.  If you wish to see the changes, here is the agenda we linked to that was current as of last week, and here’s the updated agenda posted today.]

In comments EDF made at a November 2012 stakeholder meeting held by EPA’s Integrated Risk Information System (IRIS) program, we warned that the tendency of the IRIS program to respond to criticism by expanding opportunities for “public” input would serve to increase rather than decrease the imbalance in stakeholder input.

We noted that providing more opportunities for participation not only lengthens the timeline for completing assessments; it also virtually ensures the input received by EPA is imbalanced and badly skewed toward the regulated community. That’s because companies that produce and use each chemical to be assessed – and the trade associations and myriad hired consultants that represent them – have a clear vested financial interest in the outcome of the assessment.  They can and will take advantage of each and every opportunity for input, and they will be better represented than other stakeholders each and every time.

IRIS recently began holding bimonthly meetings focused on “key science issues” relating to upcoming assessments.  And guess what?  An army of industry representatives, including staff for trade associations and paid consultants, are overwhelming the agendas.

Exhibit A:  Have a quick look at the list of speakers in the agenda for this month’s bimonthly meeting.  A striking imbalance, no?  As many as 8 industry representatives are set to speak on a given issue, including 6 from the same consulting firm!  [UPDATE 6/24/14:  See the top of this post for a description of the updated, slightly more balanced agenda; here is the agenda we had linked to that was current as of last week, and here’s the updated agenda posted today.] Read More »

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