Selected tags: National Academy of Sciences (NAS)

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 »

Posted in Health Policy, Health Science, Industry Influence| Also tagged , , | Comments closed

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 »

Posted in Health Policy, Health Science, Industry Influence| Also tagged , , | 2 Responses, comments now 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 »

Posted in Health Policy, Health Science, Industry Influence| Also tagged , , | 2 Responses, comments now 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| Also tagged , , , | Comments closed

EDF comments at National Academy of Sciences workshop on “weight of evidence” in chemical assessments

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

This week I attended a workshop sponsored by the National Academy of Sciences’ Committee to Review the IRIS Process.  This committee was established in response to a rider attached to an “omnibus” spending bill passed by Congress in late 2011.  The committee’s charge is to “assess the scientific, technical, and process changes being implemented by the U.S. Environmental Protection Agency (EPA) for its Integrated Risk Information System (IRIS).”

EPA describes IRIS as "a human health assessment program that evaluates information on health effects that may result from exposure to environmental contaminants."  The key outputs of IRIS assessments are one or more so-called “risk values,” quantitative measures of an “acceptable” level of exposure to the chemical for each cancer and non-cancer health effect associated with the chemical.  IRIS risk values are in turn used by regulators to set everything from cleanup standards at Superfund sites to limits in industrial facilities’ water discharge permits.

This week’s workshop – a detailed agenda is available herewas intended to provide expert input to the committee to inform its review of IRIS.  It focused on the complex and controversial issue known as “weight of evidence” (WOE) evaluation.  Here WOE refers to how EPA – in conducting an IRIS assessment of a particular chemical – selects studies, evaluates their quality, and assesses and integrates their findings, as well as how it communicates the results.  At issue in particular in a WOE evaluation is how the assessor determines the relative importance – or weight – to be given to each study.

One of the many issues that came up in the discussion of WOE is how to identify and assess the “risk of bias” in individual studies – a concept borrowed from the evaluation of the reliability of clinical trials used in drug evaluations.  (See this Powerpoint presentation by one of the committee’s members, Dr. Lisa Bero, which provides a nice overview of risk of bias in that setting).  Evaluating a study’s risk of bias is critical for assessing its quality and in turn the weight it should be given, because bias in studies can result in significant under- or overestimates of the effects being observed. 

One type of bias is so-called “funder bias.”  Dr. Bero and other researchers have documented through extensive empirical research that there is a significantly increased likelihood that a study paid for by a drug manufacturer will overstate the efficacy or understate the side effects of a drug.  As to studies of environmental chemicals, at the workshop and more generally, the chemical industry has pointed to adherence to Good Laboratory Practice (GLP) standards as a sufficient antidote to bias, including funder bias, a notion that has been heartily disputed by others.

But enough background.  My intent here is not to fully describe the workshop discussions, but rather to provide the comments I presented during the public comment period at the end of the meeting.  My comments addressed the issue of funder bias and also sought to urge the committee not to dive so deeply into the weeds in reviewing and proposing enhancements to EPA’s IRIS process that it loses sight of the need for a workable IRIS process that is able to provide in a timely manner information so critical to ensuring public health protection.

Read More »

Posted in Health Policy, Health Science| Also tagged , , , , | Comments closed

The chemical industry says formaldehyde and styrene don’t cause cancer. Only one of 52 scientists agree.

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

Last week, the National Academy of Sciences (NAS) held a joint meeting of its two panels that are charged with reviewing the listings of formaldehyde and styrene as carcinogens in the 12th Report on Carcinogens, which was released in June 2011.

The 12th Report on Carcinogens (RoC) is the latest edition of a Congressionally mandated report developed by the National Toxicology Program (NTP).  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.”  That put the chemical industry into a real tizzy, what with the threat these listings pose to its profits from the huge volumes of these cash cows sold each year, not to mention the huge potential liability it faces.

Never one to go down lightly, the American Chemistry Council (ACC) has launched an all-out assault on the NTP and the RoC.  It is waging battle not only with the executive branch, but also in the courts and in Congress.  In late 2011, it managed to get its allies in Congress to slip into the Consolidated Appropriations Act of 2012, without any debate, a rider that mandated the NAS reviews of the formaldehyde and styrene listings in the 12th RoC that are now underway.

ACC also pushed legislation in the last Congress to shut down all funding for the RoC until the reviews are completed; failing on that front, earlier this month it demanded that NTP cease all work on the next (13th) edition of the RoC.  (For more background, see previous blog posts by EDF and NRDC.)

Lost in all this kerfluffle, however, are these salient facts:

  • The formaldehyde and styrene listings are the outcome of one of the most extensive scientific assessment processes on the planet, entailing reviews by four separate groups of expert scientists for each chemical.
  • ACC as well as the public had at least three separate formal opportunities for providing input to these expert bodies.
  • Of a total of 52 votes cast by these scientific panels on the NTP’s recommended listings, 51 of those votes supported the recommendations and only one opposed them. Read More »

Posted in Health Science, Industry Influence| Also tagged , , , , , , , | Comments closed

Scientists push back against a bill that would pervert the whole concept of conflict of interest

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

This week, two letters – one signed by 13 prominent public health scientists and the other signed by the heads of 8 major national environmental organizations – were sent to the House Science Committee voicing strong opposition to H.R. 6564, the EPA Science Advisory Board Reform Act of 2012.

The sponsors of this legislation claim that it is needed to “enhance transparency and limit conflicts of interest” on the Environmental Protection Agency’s (EPA) Science Advisory Board (SAB) and its panels.  In fact, it would do the precise opposite.  Here’s how the scientists’ letter summarizes the impacts that would arise from passage of the bill:   

“This proposed legislation would only serve to reverse progress in bringing the best scientific advice and analysis to EPA.  The consequence would be to deprive EPA of needed scientific advice on the most complex and pressing environmental health problems of our day.” 

Among the most perverse provisions of this bill (and there are many) are two that would turn the very notion of conflict of interest on its head.  One would limit scientists that receive competitive grants through EPA’s extramural research program from serving on the SAB or its panels – claiming that such funding constitutes a conflict of interest.  The scientists’ letter goes directly at that provision:

“The underlying idea that scientists who obtain funding from EPA for any project have conflicts about all EPA matters is baseless and reflects a misunderstanding of who we are as scientists and our role in society.”

Another provision is even more perverse:  It would reverse longstanding conflict-of-interest policy and practice followed by virtually every authoritative scientific body in the world – including the National Academy of Sciences, the International Agency for Research on Cancer and the World Health Organization – by allowing unfettered access of industry representatives with direct conflicts of interest to serve on the SAB and its panels, as long as their conflicts are disclosed.

Who’s behind this radical legislation?  Here’s a hint:  The American Chemistry Council (ACC), which represents the chemical manufacturing industry, couldn’t wait to express its unequivocal support, stating it “cannot overstate the importance of this bill to Americans” in a press release titled “House Science Committee Proposes Common Sense Reform To EPA Scientific Advisory Process:  Proposed Legislation Would Improve Expert Panel Selection, Limit Conflicts of Interest and Enhance Systematic Reviews.”  And ACC’s been singing the bill’s praises all over town ever since (see, e.g., slide 6 of this ACC presentation).  Read More »

Posted in Health Policy, Industry Influence, TSCA Reform| Also tagged , , , | Comments closed

EDF comments at EPA's public stakeholder meeting on its IRIS Program

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

I provide in this post the comments I delivered as a panelist at the Environmental Protection Agency's (EPA's) November 13, 2012 Public Stakeholder Meeting on its Integrated Risk Information System (IRIS) program.  EPA describes IRIS as "a human health assessment program that evaluates information on health effects that may result from exposure to environmental contaminants."

 

The theme of my comments today is the critical need to restore balance to the IRIS program.  In my view, the program’s structure and practice have over time tilted badly toward allowing one set of interests and desirable attributes of chemical assessments to wholly dominate over another, equally critical set.  Let me explain.  Read More »

Posted in EPA, Health Policy, Health Science| Also tagged , , , , | 1 Response, comments now closed

EDF launches website on EPA’s emerging chemical testing programs

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

New approaches for evaluating chemical hazard and risk are needed to help address substantial data gaps that exist for the thousands of chemicals currently in the marketplace as well as those yet to be introduced.   EPA has been investing significant resources to create research programs dedicated to advancing new types of chemical testing and assessment approaches.  But what exactly are these approaches?  How might they improve the practice of risk assessment?  Are they appropriate for decision-making, and if so, what kinds of decision making?  What role does the public interest community have to play? 

To explore these and other important issues, EDF’s Health Program has launched a website, “Chemical Testing in the 21st Century,” that provides an  introduction to these new approaches and the programs the EPA has built around them—including their potential uses, benefits and limitations.  The website includes the following informational resources: 

  1. Chemical Testing in the 21st Century: A Primer – An introduction to EPA’s Computational Toxicology (CompTox) research initiative and its component programs, such as ToxCast; a discussion of the opportunities and challenges of these new testing programs; and a discussion of issues and needs for greater engagement by the public interest community.  
  2. Chemical Testing in the 21st Century: Webinar Series – Linked audio and video recordings of each of EDF’s three webinars (held in October) featuring EDF and EPA scientists exploring the basics of EPA’s new testing programs and the promises and challenges they present. 

We will soon be adding a page with descriptions of and links to additional resources.

Posted in Emerging Testing Methods, Health Science| Also tagged , , , , , | Comments closed

Hands off the Report on Carcinogens

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

Information, and importantly, access to reliable and objective information, is the cornerstone of a democratic society.  That is why recent efforts by the chemical industry and its allies to block Congressionally-mandated, scientific information on carcinogenic hazards by defunding the Report on Carcinogens (ROC) have many researchers and public health officials alarmed. 

Today, in a letter sent to House and Senate appropriations committee leaders, 75 occupational and environmental health scientists and professionals from around the country called on Congress to maintain funding for the ROC.  Their letter is in response to a legislative proposal that, if passed into law, would withhold funding for any work on the ROC until the National Academy of Sciences (NAS) completes its review of the listings of formaldehyde and styrene in the 12th ROC—a process the NAS has only just begun.  If such a proposal were successful, it would effectively delay public access to critical information on chemical carcinogens for years.     Read More »

Posted in Health Policy, Health Science, Industry Influence| Also tagged , , , | 3 Responses, comments now closed
  • About this blog

    Science, health, and business experts at Environmental Defense Fund comment on chemical and nanotechnology issues of the day.

    Our work: Chemicals

  • Categories

  • Get blog posts by email

    Subscribe via RSS

  • Filter posts by tags

    • aggregate exposure (10)
    • Alternatives assessment (3)
    • American Chemistry Council (ACC) (55)
    • arsenic (3)
    • asthma (3)
    • Australia (1)
    • biomonitoring (9)
    • bipartisan (6)
    • bisphenol A (19)
    • BP Oil Disaster (18)
    • California (1)
    • Canada (7)
    • carbon nanotubes (24)
    • carcinogen (22)
    • Carcinogenic Mutagenic or Toxic for Reproduction (CMR) (12)
    • CDC (6)
    • Chemical Assessment and Management Program (ChAMP) (13)
    • chemical identity (30)
    • chemical testing (1)
    • Chemicals in Commerce Act (3)
    • Chicago Tribune (6)
    • children's safety (23)
    • China (10)
    • computational toxicology (11)
    • Confidential Business Information (CBI) (52)
    • conflict of interest (4)
    • consumer products (48)
    • Consumer Specialty Products Association (CSPA) (4)
    • contamination (4)
    • cumulative exposure (4)
    • data requirements (46)
    • dermal exposure (1)
    • diabetes (4)
    • DNA methylation (4)
    • DuPont (11)
    • endocrine disruption (28)
    • epigenetics (4)
    • exposure and hazard (49)
    • FDA (8)
    • flame retardants (20)
    • formaldehyde (15)
    • front group (13)
    • general interest (22)
    • Globally Harmonized System (GHS) (5)
    • Government Accountability Office (5)
    • hazard (6)
    • High Production Volume (HPV) (22)
    • in vitro (14)
    • in vivo (11)
    • industry tactics (41)
    • informed substitution (1)
    • inhalation (18)
    • IUR/CDR (27)
    • Japan (3)
    • lead (6)
    • markets (1)
    • mercury (4)
    • methylmercury (2)
    • microbiome (3)
    • nanosilver (6)
    • National Academy of Sciences (NAS) (20)
    • National Institute for Occupational Safety and Health (NIOSH) (7)
    • National Institute of Environmental Health Sciences (NIEHS) (5)
    • National Nanotechnology Initiative (NNI) (7)
    • National Toxicology Program (1)
    • obesity (6)
    • Occupational Safety and Health Administration (OSHA) (3)
    • Office of Information and Regulatory Affairs (OIRA) (4)
    • Office of Management and Budget (OMB) (16)
    • Office of Pollution Prevention and Toxics (OPPT) (3)
    • oil dispersant (18)
    • PBDEs (16)
    • Persistent Bioaccumulative and Toxic (PBT) (22)
    • pesticides (7)
    • phthalates (17)
    • polycyclic aromatic hydrocarbons (PAH) (5)
    • prenatal (6)
    • prioritization (35)
    • report on carcinogens (1)
    • revised CSIA (3)
    • risk assessment (69)
    • Safe Chemicals Act (24)
    • Safer Chemicals Healthy Families (33)
    • Significant New Use Rule (SNUR) (20)
    • Small business (1)
    • South Korea (4)
    • styrene (6)
    • Substances of Very High Concern (SVHC) (15)
    • systematic review (1)
    • test rule (17)
    • tributyltin (3)
    • trichloroethylene (TCE) (3)
    • Turkey (3)
    • U.S. states (14)
    • vulnerable populations (1)
    • Walmart (2)
    • worker safety (23)
    • WV chemical spill (11)
  • Archives