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Embryonic Stem Cell Research: Shock and Awe Strike Again

Last week, U.S. District Judge Royce Lamberth issued a preliminary injunction to stop Obama's reinstatement of some of the federal funding for embryonic stem cell research.

The plaintiffs included Christian Medical Association; the Nightlight Christian Adoptions, an agency that sells the use of frozen embryos it calls "snowflakes" - from fertility clinics; two PH.D. scientists, James Sherely of Watertown, Massachusetts, and Theresa Diesher of Seattle, who do research on adult stem cells and claim that allowing embryonic stem cell research wrecks their chances of getting federal grants; clients for adopted embryos; and the embryos frozen in IVF clinics.

Lamberth previously ruled that none of these plaintiffs or cells had legal standing. However, the two Ph.Ds won standing when they appealed, on grounds that their adult stem cell research would be compromised if they had to compete for federal grants with embryonic stem cell research. Lamberth issued the preliminary injunction based on his judgement that the plaintiffs would prevail when the case went to trial, therefore they needed immediate relief because they're livelihoods were impacted by Obama's expanded hESC funding directive.

Judge Lamberth's decision was based on the Dickey-Wicker Amendment attached to every Department of Health and Human Services (HHS) bill since 1996. The rider was a pro-life fueled measure, intended to prevent cloning for research purposes. Since 1996, the Dickey-Wicker Amendment has ostensibly prohibited the use of federal funds for:

  • "the creation of a human embryo or embryos for research purposes;" or
  • "research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury or death greater than that allowed for research on fetuses in utero under" certain existing laws."

Nevertheless, three administrations, the Clinton, Bush, and Obama, have allowed various levels of federal funding on research on embryonic stem cell lines. The judge's injunction goes so far as to roll back former President Bush's limited acceptance of federally funded stem cell research for certain stem-cell lines created by 2001. The Federal government has requested a stay (.pdf) of the injunction. Who will prevail? The government? Plaintiffs?

Science Community Stunned

The legal move was a blow to the science research community. Said NIH Director Francis Collins: "The NIH was frankly, I was stunned - as was virtually everyone here at NIH - by the judicial decision yesterday".

But remember, back in 2001, prior to the 2002 elections in which Republicans gained seats, and when President Bush was making decisions about stem cell research. A similar group of plaintiffs sued the government. The plaintiffs in Nightlight Christian Adoptions et al v. Thompson included Nightlight Christian Adoptions, the Christian Medical Association; two couples who wanted to adopt embryos and said that stem cell research reduced availability of embryos for adoption; and Dr. David Prentice, a former professor of life sciences at Indiana State University who said that there were better alternatives to hESC, who is now a fellow at the Family Research Council.

Now, nine years later, right before mid-term elections and after Obama plans to expand funding for stem cell research, we have basically the same lawsuit, from basically same plaintiffs.

People have various opinions about what the injunction means and how it will progress in the courts. A lawyer and commenters here at concurringopinions.com discuss why the government will prevail (or won't).

Some scientists speculate that the importance of federally funded embryonic stem cell research has faded, because so much work is done privately. Others, including the plaintiffs, argue that inducible pluripotent stem cells (iPSC) or adult stem cells are just as promising. But most people don't find these arguments too persuasive, and agree that embryonic research is at least a necessary prong to pursue potentially life-saving research. Of course "pro-life" and Christian groups argue that the blastocysts are people which shouldn't be used for research, even if it will save lives.

The plaintiffs' arguments do not persuade for many reasons. Their claim to economic injury is not only unconvincing on its face, considering the plaintiffs and NIH funding structure, it's dwarfed by the impact that stopping the research would have on the lives of sick people. As well, the livelihoods of the researchers are in jeopardy, as is the investment of millions of dollars of government funding that the judge's order seeks to abandon. 24 research projects in which the government has spent $64 million are currently threatened (.pdf) because they had been scheduled to receive $54 million in continuing NIH funding at the end of September.

Should Scientists Have Been Surprised

I was. But maybe I wasn't paying close enough attention. Or maybe I didn't want to believe that such anti-reason would even get a chance. But apparently, all it took was the "right" plaintiff and the "right" judge, at the "right" time.

It's sometimes easier for people (including scientists) to perfunctorily dismiss as terminally unenlightened or misguided, those who hold politically opposing views, for instance those who believe in Creation over evolution. Maybe it's not as head-splittingly frustrating as arguing or teaching. Perhaps a quick witted turn of phrase can morph anti-reason into fodder for jokes, yay! And why not deflect an ugly stand-off with some humor?

James Taranto, of the Wall Street Journal, for one, says that dismissive attitudes (here's one example I thought of: "Poll: So You Want to Build a Mosk?") harms liberal causes because 1) they tend to "mainstream those supposedly fringe notions" (ie: Pew Research Polls that constantly highlight subjects of "culture wars"), and 2) they "put the ugly attitudes of the liberal elite on display."

Scientists discuss these things frequently and blogging scientists have consumed years writing, discussing, comparing and vehemently arguing about various approaches -- hostility, framing, teaching, patience, humor, tolerance, diplomacy, "accomodationism", to deal with anti-reason. (Personally, I can't get attached to one approach or think another is "bad", I believe different writers and audiences will gravitate towards one communication method or another. They complement each other. )

But regardless of whether scientists are "civil", hostile, sarcastic, or choose to ignore what offends them, I wonder if all approaches are fatally flawed not only because of the reasons Taranto and scientists usually discuss, but because scientists are so up to their necks in scientific method. Do we then let ourselves believe that reason will prevail? And does that lead us to ignore what's at stake? The incredible belief everyone had in Obama that he could somehow transcend politics, indicates this may be so. Francis Collins "stunned" response indicates this may be so. Collins, if anyone, with his position and overt religiosity -- he's written books on this! -- should have had his ear to the ground.

Maybe it's a tempest in a teapot, as many seem to think. Maybe Lamberth had an off day and will change his mind, maybe the courts (moving right every day) will come to their senses. But at the moment, those who want to stop hESC seem to be determinately bulldozing things their way, decade after decade.

Wikileaks - Publish & Perish?

Wikileaks founder Julian Assange, in an interview with John Pilger, was asked if it was difficult to publish secret information in Britain. Assange answered:

'When we look at Official Secrets Act labelled documents we see that they state it is offense to retain the information and an offence to destroy the information. So the only possible outcome we have is to publish the information."

Elsewhere on the continent, Wikileaks founder Julian Assange is a hunted man, or so it seems, he has the - I_haven't slept_or_been_able_to_wash_my_hair_in_weeks - look. Fleeting charges about rape made by Sweden were dropped hours later, but the real story remains elusive. The tabloids picked up to explain. Aftonbladet asked one of the women about the rumored Pentagon connection:

De konspirationsteorier som mmar nätet just nu avfårdar kvinnan i 30-årsålden bestämt.

"Anklagelserna mot Assange är förstås inte iscensatta av varken Pentagon eller någon annan. Ansvaret för det som hänt mig och den andra tjejen ligger hos en man med skev kvinnosyn och problem att ta ett nej."

Which gave us a chance to try out Google's Swedish, which translated the exchange as:

The conspiracy theories that are flooding the web right now dismisses the woman in her 30s decided.

"The charges against Assange is of course not orchestrated by either the Pentagon or another. The responsibility for what happened to me and the other girl is in a man with skew kvinnosyn problems and to take no for an answer."

We're not sure what happened with "skew kvinnosyn", whether Google was stumped or censoring. But see? It's not true, any of it, including the bit about the Pentagon.

But it reminds us of the story that came out earlier this year about US government hanky-panky mischief. the FBI learning from listening in on a CIA Iraq Operations Group about an unrealized plan to make-up a video about Saddam Hussein's sexual exploits. Spencer Ackerman of the Washington Independent wrote earlier this year about another ill-advised CIA plan to use Afghan women to elicit sympathy for the war against the Taliban.

AB-70 - Legislation on the Fly and Bring Your Genes to Cal

Update 08/13: AB 70 was defeated. However, the Bring Your Genes to Cal program was altered because they planned to do the analysis in Berkeley labs, which are not certified medical labs. In accordance with state demands the students will not receive their own results.

Legislation usually moves along at a crawl, slowly, glacially -- except if you're the California State legislature trying to corral the University of California, Berkeley's personal genomics walkabout offered to incoming freshmen. The state bill AB 70 was introduced in December, 2008 to encourage transparency on how school districts classify "English learners" to "proficient".* Now, the text of AB 70 the "English learners" bill has been parasitically devoured and replaced with text to impede the University of California, Berkeley's program for incoming students, known as: "On the Same Page: Bring Your Genes to Cal".

How the State Tries to Come Between Cal...and Your Genes

Like many universities, freshmen are welcomed to UC Berkeley with some thematic program. Historically that's meant they all read a book, for instance last year they read Omnivore's Dilemma, by Michael Pollan. This year they decided on a more interactive learning experience, asking incoming Freshman to spit in a cup and submit that for analysis of lactose, alcohol metabolism, and folate gene variants. The idea seemed fresh and relevant, and Berkeley went forward with it apparently without much internal debate. Certainly getting students involved in their own health can't be bad can it?

Some people actually thought it was bad, however, and eventually the state legislature got involved -- very late to the game, of course. But as the university mailed out saliva spit kits to students, AB 70 suddenly gained what seemed like unprecedented speed and "urgency". If passed, it will be "enacted immediately."

The original AB 70 proposed adding a section to the education code requiring that school districts report their criteria for assessing English proficiency. The bill languished until being amended June 24, 2010. The amended title reflected not-too subtle changes. The old sponsor and bill purposes were simply crossed out, and the new sponsor and purpose inserted so it read:

"Duvall Norby English learners. Public postsecondary education: genetic testing."

That's how an English learners bill morphed into a bill to stop UC Berkeley from teaching about genetic testing.

Legislation 101

English learners text was crossed out:

....This bill would require the department, as part of its duties in administering the English language development test, to gather from each school district that has one or more English learners the criteria that the district uses for the reclassification of a pupil from English learner to proficient in English and to summarize and report the criteria it receives...

And in its place, text warning about allowing "On The Same Page: Bring Your Genes to Cal":

  • Collecting, testing and storing genetic material presents "unique challenges to protecting individual privacy".
  • Medical testing "subjects" should receive "substantial" written and verbal explanation before supplying consent
  • Students "may feel coerced to participate in official activities involving widespread genetic testing"
  • A 2006 GAO report showed that tests are "unproven, misleading, meaningless.."
  • Students could "suffer consequences later in life" because of privacy breaches.

The June 24th version demanded that the school report quarterly, all the costs of the "solicitation" so that the state of California could recoup those expenses. The trouble with that legislation was that the solicitation already happened and was funded with a gift (probably, the funding is unclear). (The state only provides Berkeley with a small percentage of its funding.) So the August 02 amended version of AB 70 struck out "prohibits" and entered "requests" instead. The August version also struck out the demand for accounting of "unsolicited requests", and replaced that for a demand to account for "legal judgements or settlements resulting from violations of the informed consent requirements".

On Different Pages

The August amendments show the state adjusting to meet the realities of the program moving forward. It's a learning experience for all. Clearly the legislature is trying to wrap its head around the project, and adjusting as needed. As is Berkeley. As are organizations who oppose the program.

The text of the bill reflects very closely the rhetoric of the Massachusetts based Council on Responsible Genetics (CRG). Their primary concern seems to be privacy, and their multiple letters to California legislators practically dictate the content of AB 70. But as they gather more information about the project, they too change their rhetoric. In their most recent letter to California legislators, the Council For Responsible Genetics joined with the ACLU, Privacy Rights Clearinghouse, The Electronic Freedom Foundation and others, urging the legislators to "request a full accounting" of the "On the Same Page: Bring Your Genes to Call" program, specifically issues of conflict of interest, funding, privacy, and data confidentiality.

The Berkeley program certainly brings relevant topics to the fore, and who can challenge the importance of this? But Berkeley scientists and the Council on Responsible Genetics have stuck doggedly to their talking points. Scientists advocating the program stress the need for education about genomics, and accuse critics of being anachronistic and paternalistic. They stress individuals personal right learn genetic information. Therefore, they would argue, this is a relevant topic worthy of the attention of the program.

Certainly healthcare in America is at such a nadir that anyone with half a brain in their head who has visited a doctor lately would agree that giving individuals more information to take more ownership of their own healthcare would be great. Personal genomics could give such insight, democratize information, and benefit health consumers. But this is one (there are others) big hitch. Direct to consumer genetics testing (this is related) walks a fine line between being innocuous information and a "medical test". Bring Your Genes to Cal proponents simultaneously push the importance of the students learning about genomics - and by pushing this they get necessary support, while at the same time belittling the relevance of the tests and their results - so as not to attract unwanted attention.

Meanwhile, critics are focusing on the very issues that the University is trying to downplay. CRG insists on repeatedly labeling the Bring Your Genes to Cal tests "medical tests" in order to prompt alarm and greater scrutiny. The critics dwell on privacy, data confidentiality, and interpretation of data. To me, if genomics data is important enough that it's worth building this program around (as innocuous seeming as these variants may be), than it's important enough for the critics' issues to matter -- even if the involved scientists twist themselves into knots to avoid those discussions.

The state, for its part, is trying to respond, quickly at that, without having a clear handle on the issues. Perhaps they yearn for 2008, when AB 70 was stymied in controversy over adding a webpage to assure transparency in schools' English Learner programs.

------------------------

*AB 70 was also once a bill about state dams.

"Did the EPA drop bisphenol A from the list in eight days because of lobbyists? First of all, if the EPA or any government agency reversed a decision like this in eight days it would be a grand miracle on the scale of the Genesis seven day creation myth. Or at least worthy of an Olympic gold medal. Really..."

Post Updated 2/19/10 to include new references.

The EPA, Skewered For First TSCA Action in Decades:

On December 30th, the Environmental Protection Agency (EPA) posted action plans for four chemicals: phthalates, perfluorinated chemicals (PFCs), polybrominated diphenyl ethers (PBDEs), and short-chain chlorinated paraffins. (No really! It gets better :-) ) An action plan signals that the EPA intends possible regulation because the chemical poses a hazard. Chemical companies complained bitterly. The EPA also listed two more chemical action plans in the development process, for benzidine dyes/pigments, and bisphenol A. Scientific American commented at the time:

"This is a big deal because it is the first time since TSCA was passed in 1976 that the EPA has made such a move. To date, the agency has only successfully used TSCA to restrict or ban five of the 80,000-plus chemicals on its inventory"

However this week, the Milwaukee Journal Sentinel criticized the EPA's December chemical action plans, questioning why bisphenol A wasn't on the top four list: The EPA's "move" was "drawing suspicion", explains the paper:

"the head of the Environmental Protection Agency had been talking tough in one speech after another last fall about the need to protect the public from such chemicals, particularly BPA...but when the agency's list came out Dec. 30, identifying four chemicals that would face stricter labeling and reporting requirements, BPA was not among them..."

Writes MSJ: "Critics say the Dec. 22 meeting might have been why BPA was dropped from the top of the agency's list".

BPA is on the agency's list. But to the Journal-Sentinel's question, why is it not first up in the most recent round of action plans? Did lobbyists pressure OMB/OIRA to change EPA's stance on Dec. 22?

Now, Suddenly, The EPA Turns on A Dime?

The paper cites as the deciding factor a meeting of plastic and chemical lobbyists with the Office of Management and Budget (OMB) and the Office of Information and Regulatory Affairs (OIRA):

"Eight days after a meeting between chemical industry lobbyists and Obama administration officials, federal regulators put off including bisphenol A on a list of dangerous chemicals that would be subject to stricter regulation"

The Center For Progressive Reform also forwarded the idea that the EPA was influenced to remove BPA from its chemical action plans list in a blog posted January 22:

"on December 22, just before EPA was about to release its first four chemical action plans, activists from American Chemistry Council and representatives of a major BPA producer met with officials at OIRA to plead the case for BPA's safety."

Did the EPA drop bisphenol A from the list in eight days? First of all, if the EPA or any government agency reversed a decision like this in eight days it would be a grand miracle on the scale of the Genesis seven day creation myth. Or at least worthy of an Olympic gold medal. Really.

But, lets look back to last fall, to a much quoted speech given by Lisa Jackson to the Commonwealth Club in San Francisco. The MSJ quoted the speech in their article. At the time, we wrote in "The EPA Speaks To Me" that Jackson's speech, like the president's sweeping public orations, promised something for everyone:

"The more I read, the more Jackson's speech looked like a veritable public relations jambalaya. She spoke to those committed to wetlands, spotted owls, to asthma sufferers, climate change, to those concerned about coal and gas emissions, to the Clean Air Act, to trash incineration, dioxins, pesticides, green chemistry, research, unions, medical professionals, public health groups, industry, environmentalism, to those who want jobs, fast food packaging, to unborn children, African Americans, Native Americans, Latinos and postal workers, as well as everyone who emails public comments to the EPA or who's concerned about health care or health..."

I commented at the time that her speech was clearly a "marketing tool and conversation generator but not a public policy statement." We could get mad about a lot of things in her speech, I'm sure, if we took it as public policy commitment.

If Only Talking Made Policy

Of course, in that speech Jackson did mention bisphenol A, saying: "Every few weeks, we read about new potential threats: Bisphenol A, or BPA - a chemical that can affect brain development and has been linked to obesity and cancer..." Or, as the Milwaukee Journal Sentinel sees it: "The first chemical on her list: BPA." But, writes MSJ: "In the end, though, her agency settled on four other chemicals to target first for the action plans." (emphasis ours)

So as MSJ says, it's true, "first" Jackson did mention BPA. Then she said "pthalates", then "dioxins, then "lead" (each once). One of the Journal-Sentinel's sources labeled EPA's stance as "curious". I'm as cynical as anyone, but lets look at Jackson's rhetorical choices.

San Francisco was the first in the nation to attempt action on bisphenol A and phthalates. Jackson was at the San Francisco Commonwealth Club talking to (I guess) some commoners -- not chemists or policy wonks. "Bisphenol A" and "pthalates", "dioxin", and "lead" would be recognizable and appreciated by the crowd. True, she didn't explicitly mention "polybrominated diphenyl ethers (PBDEs) including the commercial versions of pentabromodiphenyl ether (c-pentaBDE), octabromodiphenyl ether (c-octaBDE), and decabromodiphenyl ether (c-decaBDE)" -- the flame retardants in the first batch of four EPA action plans. But had she, the crowd, eyes glazing over, probably would have slumped into trance instead of thinking the EPA was their friend and ally. Whether you view this as PR or marketing or just common sense, its elementary communication. And as an aside -- why no concern about the EPA's omission of lead or dioxin in the first batch of action plans?

Sept. 29th: EPA Announces Four Chemical "Action Plans". Sept. 30th: Names Chemicals

As for the EPA's choice of which chemicals would be targeted first, on September 29, 2009 , the EPA issued a press release" right after Jackson's speech, announcing its intention to issue four action plans in December:

"The EPA has identified an initial list of chemicals for possible risk management action and anticipates completing and posting an initial set of four action plans in December. It will complete and post additional chemical action plans in four-month intervals thereafter."

On September 30, 2009, the EPA issued another press release, naming the four chemicals of top interest, the same ones that it produced action plans for in December:

"EPA today announced a series of actions on four chemicals raising serious health or environmental concerns...The agency's actions represent its determination to use its authority under the existing Toxic Substances Control Act (TSCA) to the fullest extent possible...In addition to phthalates, the chemicals EPA is addressing today are short-chain chlorinated paraffins, polybrominated diphenyl ethers (PBDEs) and perfluorinated chemicals, including PFOA.

So in a September 30th press release, the EPA named the same four chemicals that were in the December 30, 2009 action plan announcement. Then did the American Chemistry Council (ACC) really sway the EPA's BPA decision in a meeting December 22nd with OMB/OIRA, eight days before the EPA's action plan announcement?

The Chemical Lobby, BPA & The EPA: Economics Factors?

To me, aside from the overly conspiratorial premise of the article, the Milwaukee Journal-Sentinel and CPR valuably point the public's attention to some enviable industry access. The ACC sent five representatives to meet with four OMB,OIRA staff; and SABIC, a Saudi BPA manufacturer, sent two. The ACC apparently sent a letter requesting the meeting dated November 3rd. This is news: If you're a chemical lobby group or a Saudi BPA manufacturer, you can get a meeting with OMB/OIRA in a month and a half.

ACC also submitted a slim bibliography(.pdf) of research sources. The ACC submissions show the industry's dedication to a relentlessly one-sided messaging on chemical safety.

Six of fifteen studies in the bibliography have ACC's Steve Hentges (meeting attendee and ACC lobby spokesperson, who has relentlessly messaged about BPA safety) listed as the senior author (not unbiased). Three industry related studies intend to prove that BPA degrades quickly, which is an important criteria for EPA action plans. At least four other studies with various aims are authored by groups sponsored by plastics, BPA or chemical foundations. It's true, as the MSJ writes, most of the studies authors have industry affiliations. There are hundreds of other studies to choose from which wouldn't bolster the ACC's arguments one tiny little bit. (Although to be fair, the ACC is a chemical lobby group -- not an unbiased journalist, a point I'd hope the EPA recognizes)

But the ACC included one study from Ryan et al published in Toxicological Sciences (Online October, 2009), that is an EPA study conducted by EPA employees. This study concludes that low-dose bisphenol A does not alter puberty, fertility, or anatomy and sexual behavior in rats, compared to the estrogen control. Several groups dispute this study because, for one, the strain of rat is not as sensitive to low-dose estrogen" (.PDF Update 02/19/10). However the study's sponsoring author has disputed their claims (which are longstanding) to Trevor Butterworth of Stats.org, which has been doing PR on behalf of the bisphenol A industry. We previously discussed Stats.org's role in several posts.

If anything might dissuade the EPA from acting on BPA it would be its own studies (which they didn't need the ACC to highlight.) The senior author on the study, L. Earl Gray Jr., also testified before the EPA in 2008, emphasizing that his level of "concern" (an agency measure of potential harm) about bisphenol A exposure was less that his level of concern for phthalates exposure. Industry groups have touted Ryan's and Gray's work. If the Ryan and Gray's study methodology is in question, no activist has been too public about it (Update 02/19/10: A letter in Toxicological Sciences published 02/17/10 explains the problem with rat strain.) Perhaps more media focus should be placed here, on the EPA's own study.

The ACC letter requesting the meeting asks for chemical industry participation in the EPA decision making process (a request that seems rather unnecessary given the easy access industry does have). The letter also asks EPA to "be sensitive to the potential and foreseeable negative effect on the marketplace...the market impact on bisphenol A demonstrates this is a serious and real concern." Of course this is the primary goal of ACC, to urge the EPA not to impact any one of 80,000 chemicals' markets.

The EPA, in contrast, has said that its priority is to "review all chemicals against safety standards that are based solely on considerations of risk - not economics or other factors." (emphasis ours). It will be interesting to see how the EPA decides on bisphenol A, and whether its considerations to "risk" will include industry consideration to economic factors - or not. However just the fact that OMB and EPA were willing to sit with the ACC lobby group shows a willingness to listen to their (always) economic arguments.

The EPA -- Total Pushover?

I don't think I'm particularly naive in these matters, we've been following industry influence on policy for a while, especially BPA, which we've been following since 2005. We've specifically written about EPA apparently backing off of regulation under pressure from OIRA/OMB several times before.

But I'd be surprised if the EPA turned their intentions for BPA around based on this meeting. First, it appears from their press releases that they had already concluded back in September which four chemicals were first up for action plans. The idea that they would be so swayed is practically absurd, given the transparently, almost lazily, self-interested documents submitted by industry. Somehow I have more confidence in this EPA then to think they changed action plans based on those almost disrespectful pleas. But they do, now, have their own scientists saying that BPA isn't as dangerous as phthalates.

Clearly the EPA is not quite committed to regulating BPA as activists want. But it has put $30 million towards EPA research. It's also conducting its own studies. Hundreds of science studies provide evidence that BPA is harmful, but there are enough impacts from EPA decisions on industry that the agency needs to continue its BPA investigation. However, consider dioxins, another chemical the EPA mentioned in its Commonwealth Club speech. Dioxins are proven to be carcinogenic, a far more damning research finding than has to date been applied to BPA, but the EPA is still struggling to contain their use. On BPA, I'd be the first to say that there's enough research, as would many states and communities. But federal policy-making is not science. So is it more than poppycock to suggest that the EPA was singularly pressured by one ACC meeting to change its mind on BPA?

Stop The Carp, Or Eat It

Carp, a Problem -- And The Government Solution

A couple of weeks ago we reported that scientists feared Asian carp had invaded the Great Lakes. Sure enough, scientists recently found carp DNA in Lake Michigan, an ecological problem considered so serious that the Supreme Court weighed in on the issue last week. (The Supreme Court said NO to Michigan, Minnesota, New York, Ohio, Wisconsin, and Ontario, who together requested that the court allow the locks be closed to prevent the carp from impacting the $7 billion dollar fisheries industry).

Who could suggest a solution? Fortunately, the entrepreneurial government of the United States (but not SCOTUS) can tackle this kind of stuff. Now, some government go-getters suggest marketing the carp as "Silverfin" (not to be confused with the "silverfish", a revolting insect) to strengthen the filter-feeder's appeal to diners.

The Louisiana Department of Wildlife & Fisheries hatched the carp plan, identifying eleven "activities" to help rebrand the invasive fish as a delicacy.

The Media Could Actually Be Helpful

Number one on the list is surprisingly obvious: "determine if silver and bighead carp are suitable for human consumption". Apparently Chef Phillipe Parola (famous for trying to push other distasteful creatures on diners, like alligator and nutria) already tested the fish with consumers, and found that the only barrier to epicurean success is "a series of floating bones that are not easily separated from the flesh". The US Geological Survey got right on it, promptly producing a video to teach chefs and sports fisherman how to clean the invasive fish.

The agency also planned various promotional activities, and here's where journalists play an important role. In a series of events, producers plan to: "present the fish products to the media...", who will be "given samples of fish and fish products to eat". Providing no journalist chokes on a bone and dies, apparently the US Geological Survey will move on to Stage II Clinical Trials.

The Geological Survey also suggests "large media events", where attendees will be habituated to the idea as carp as food, since "videos showing the fish and cleaning methods will be continuously playing".

And Scientist Could Help Too, Doing What They Usually Do -- Research

When the Supreme Court chooses to be unhelpful, maybe scientists can aid the cause. Salon Magazine interviewed "the energetic Parola", who's pushing hard to change the fish's name from "carp" to "silverfin".

Parola illustrates how some government agencies work at cross-purposes -; as he explains how the carp got its undelicious name:

Parola: "Some clown from the USDA classified it as a carp. Carps are a bottom feeders and this is a filter feeder. The shape of the fish, the way it grows, the color: Literally there is no similarity to the carp. There's no other species named the silverfin, so what's the problem?"

Salon: "Well, off the top of my head, shouldn't it be up to scientists to name the fish?"

Parola: "But what I'm saying to you -- very loudly - is that this fish doesn't have any similarity with the carp. I want somebody out there to redo that research and help us out."

There you go. Team effort. Scientists? Change the research. Do what you need to do, whatever it takes, call in the IPCC (no!! little joke)...what do ichthyologists think?

Bisphenol A, Trees on Mars, and Riveting Headlines

Headlines can be deceiving, as well all know. But we often fall for them anyway. "Are Those Trees on Mars?" asked FoxNews and 150 other news outlets last week. So I squinted at the photo, trying to imagine how those could possibly be trees...maybe if a small city like Le Mars, Iowa shipped all the old Christmas trees collected on January 8th to Le Other Mars, instead of chipping them?

nottreesonmars.jpg

A fool I was, but you can't imagine my disappointment when the article attached to the NASA photo explained that there were No Trees On Mars, only dark sand illuminated differently than the surrounding carbon dioxide ice(1) -- (Tricky editors! - 'HA, made you look'). I guess readers' attention was elsewhere last week because closer to home, more subtly, but equally misleading, news headlines announced: The FDA "reverses" its position on bisphenol A (BPA), the FDA "backtracks" on BPA, the FDA advises consumers to "limit exposure" to BPA.

These headlines seemed like real news, since the FDA has for years faiiled to come out with either actions or public statements reflecting the growing research evidence for BPA toxicity. During the Bush administration the glaring gap between the FDA's position and BPA research propelled scientists to publicly criticized the relationship between the FDA and the industries it was supposed to be regulating. Acronym Required wrote about the fraught regulatory environment in the FDA vis-à-vis BPA, in "Scientists Criticize FDA Methods on BPA", in "Conflict of Interest in the FDA?", in "FDA Panel Offers Corrections to BPA Draft", in "Bisphenol A, The FDA, Industry -- Whassup?", and others.

Given the FDA's lackluster BPA regulation history, plus the fact that BPA is almost a household word, the newest headlines on BPA and the FDA attracted everyone's attention. The New York Times listed its story "F.D.A. Concerned About Substance in Food Packaging", as one of the "most e-mailed" articles one day. But underneath the headlines, what did the stories really report?

FDA -- Aging Cheerleader?

Despite the headlines, the FDA announced no "guidelines", and no new news. The LA Times quoted a statement from FDA Deputy Commissioner Joshua Sharfstein under the title "FDA issues BPA guidelines". "For the present", Sharfstein said", the FDA does support the use of baby bottles with BPA.'" (emphasis ours)

So in essence, the FDA has offered the same counsel for years, ever since it started studying BPA. In 1995 for instance, FDA scientists found that BPA migrated from heated plastic containers. The agency remained unalarmed. In 1997 the FDA began pondering how to change regulation to reflect evidence that endocrine disruptors altered physiology at low doses -- but barely flinched.

In 1999 several consumer groups, environmental safety groups, and scientists, petitioned the FDA to ban BPA in plastic baby bottles, because research then showed without a doubt that the chemical could leach out of polycarbonate, and indicated that BPA caused sex organ problems for male babies of exposed pregnant mice. At the time, the FDA deployed Dr. George Pauli to quell rising consumer concerns and Pauli assured families that polycarbonate bottles didn't leach under 'everyday' conditions, only at high temperatures; infant formulas required only mild heating, he said. (Although, alarmingly, parents typically microwaved the bottles.)

Now, over a decade later, despite dozens more studies, the FDA is still equivocating on baby bottles, although bottles present one of the riskiest sources of BPA because of babies' vulnerability to endocrine disruptors during development.

The FDA's statement becomes all the more difficult to swallow when you know that all on their own, without any encouragement from the agency, manufacturers voluntarily pulled polycarbonate bottles for babies and adults off the shelves.

The FDA did manage to bring its assessment -- that there is "some concern" about BPA health risks -- in line with the National Toxicology Program's (NTP) assessment. Although this is no small feat given the FDA's history, the agency didn't do much else, despite delaying this announcement three times.

From the FDA website, here's what the FDA committed to:

  • "supporting industry actions" to stop making BPA containing baby bottles
  • "faciliting the development" of BPA alternatives for formula cans
  • "supporting efforts" to replace BPA in food can linings

Such mealy-mouthed statements give the impression that the FDA has little more persuasive authority than Acronym Required. The agency also said it would work with other agencies like the National Toxicology Program (NTP) in the NIEHS/NIH, and with foreign governments (legislators have aggressively questioned the FDA why it hasn't taken action when the Canada has banned BPA).

What Should Consumers Think?

The FDA is also seeking "external input" on the "science surrounding BPA", and will solicit "further public comment". Acronym Required commented on public comment periods used by agencies before. We wouldn't want to appear cynical in saying you can never have too much "public comment" or assume that the FDA is using the comment period to stall regulatory action. But since the FDA is now working with the National Toxicology Program in the NIH (NTP), it could review the numerous public comments solicited by the NTP during its assessments of the chemical in February, 2006; April, 2007; November, 2007; and April, 2008. (2)

The FDA is also "supporting a shift to a more robust regulatory framework for oversight of BPA". The FDA explains that a 40 year rule limits the FDA's ability to regulate BPA (as a food additive). The FDA can regulate new substances under a 2000 rule, but that doesn't help with BPA. So the agency will "encourage manufacturers to voluntarily submit a food contact notification for their currently marketed uses of BPA-containing materials." This is interesting because for years the FDA has been researching BPA and has declined to regulate the chemical because the agency found the science unconvincing; for some reason it hasn't brought a lot attention to its legal inabilities to regulate.

Does the FDA's latest announcement clarify its previous confusing position? What should consumers do? As my favorite headline, by "Beforeitsnews.com" byline has it: "It's in Your Urine But Is It Safe?".

More to the point, what should citizens do that they haven't done already? They've stopped buying polycarbonate, so much so that manufacturers have pulled bottles off the shelves, they've sued, they've urged local and state ordinances. By all measures, consumers have made the most credible effort to regulate BPA.

The FDA -- Nudging Itself Out of a Job? Drowning Itself In the Bathtub?

Other non-governmental organizations have responded with none of the ambiguity of the FDA. For instance spokespeople from the Breast Cancer Fund, Natural Resources Defense Council, Consumers Union, Clean New York, Center for Health Environment & Justice, and others, all urge the FDA to ban the chemical.

Even the National Council of Churches offers a suggestion for the FDA, saying, "As we celebrate the Christmas season, we are reminded of Jesus' commitment to those in poverty. We hope that the FDA will take measures to ensure that canned food is BPA-free through the use of safe alternatives in the future."

The FDA has been researching the chemical for over a decade. Their most recent statement followed delays -- not just three delays, but years of delays. Naturally the FDA, along with the CDC and NIH will support further research, in addition to supporting a new regulatory framework. The research will add to the already substantial body of research showing BPA dangers. And I guess that's how it is. The FDA is obviously hesitant to impact a multi-billion dollar industry, so the research needs to be far more conclusive than, say, if you were putting a potentially profitable pharmaceutical drug on the market.

In the meantime, as the FDA maintains relevancy by "supporting", "facilitating", and "encouraging" -- cities, towns and states across the US will continue to be at the forefront of 'patchwork' BPA regulation, pushing manufacturers to use alternatives.

--------------------------------

1 From NASA: "At that time, dark sand on the interior of Martian sand dunes became more and more visible as the spring Sun melted the lighter carbon dioxide ice. When occurring near the top of a dune, dark sand may cascade down the dune leaving dark surface streaks -- streaks that might appear at first to be trees standing in front of the lighter regions, but cast no shadows."

2 As a side note, the progression of public comments is interesting because it also shows growing awareness of BPA. In 2006 the only public comment was from the American Plastics Council. By 2008 almost 50 individuals and agencies commented.

New Strategies for Bisphenol A and Chemicals?

The Chemical Lobby Finds Their Man:

Back when the momentum for banning bisphenol A (BPA) hadn't quite built up to its current fervor, BPA lobbyists used to denigrate everyone who questioned the safety of bisphenol A. Male, female, old, young, it didn't matter, they were 'internet moms' who'd worked themselves into a blind tizzy about bisphenol A, which was 'perfectly safe'.

But things were a little more tense last May for industry leaders who met to discuss a strategy for fighting back against the growing movement to limit consumer exposure to risky levels of BPA. As we quoted the Wall Street Journal in our post back then:

"industry executives huddled for hours Thursday trying to figure out how to tamp down public concerns over the chemical bisphenol A, or BPA. The notes said the executives are particularly concerned about the views of young mothers, who often make purchasing decisions for households and who are most likely to be focused on health concerns."

In addition to crafting clever lines to scare consumers, like "do you want to have access to baby food anymore?", the industry group discussed getting the right spokesman for their cause. A scientist might be difficult they acknowledged, they had reputations to preserve, but a pregnant woman would be "the Holy Grail".

Now it looks like they found their man in a public relations expert named "Joe Householder" -- his real name. This isn't the first challenging public relations assignment for Mr. Householder. He worked with, among others, Enron's law firm, baseball player Roger Clemons, Hillary Clinton, various other politicians, and Public Strategies Inc. Now he's with Purple Strategies Inc., apparently heading a group called "Coalition for Chemical Safety". The Coalition for Chemical Safety works with American Chemical Council (ACC) and other businesses. To date, those businesses are known more for not putting the safety and health of consumers before corporate profits.

So we look skeptically at "The Coalition for Chemical Safety". Indeed, it's described by the Environmental Defense Fund (EDF) as an BPA astroturfing organization. But it takes different tactics then previous BPA astroturfing campaigns. Mr. Householder and the Coalition for Chemical Safety take a warmer approach to BPA and chemicals, astroturfing-wise, then representatives in the past have.

In step with the times, the everyone_together_at_the_same_table age of Obama rhetoric, as opposed to the more acrimonious Bush era rhetoric, the Coalition is 'educating' consumers about chemicals. Instead of saying bluntly that BPA is safe, the mother in this Coalition sound clip talks about banning BPA in baby bottles, but encourages consumers and public health advocates to always work with the chemical companies (mp3 from EDF). This is the more subtle approach to controlling the public perception of chemicals. And who better to assure "young mothers" making "purchasing decisions for households", than a guy named Joe Householder?

In keeping with this new, more collegial approach to marketing/public relations, Householder has directly engaged Dr. Richard Denison, EDF's sometimes scathing Senior Scientist, in a mano-a-mano on Denison's blog. This is Householder's "purple" strategy, I think, not red, not blue, purple -- get it? That's where we all agree that chemicals are indeed wonderful (they are) and that we love regulation, just the "right" regulation, and "reasonable" regulation. Look out for that.

Mr. Household has invited Dr. Denison to join the Coalition for Chemical Safety, and although Denison hasn't posted a public response, I think with their combined gregariousness and magnetism, it's just a matter of time before they're hanging out together, Richard educating Householder on bisphenol A and Joe sharing public relations tactics and the use of his very apropos name. Isn't that how things get done these days?

Update: 02/14/09 Dr. Denison did continue to engage Joe Householder on the EDF blog. In a February post, Denison continued to ask Householder what his funding sources were, and what PR tactics he had used to get certain sectors so riled up about the Toxic Chemical Safety Act (TCSA):

"What exactly are you telling lawn services and landscaping companies they need to worry about in TSCA reform? And just what tortuous scenario are you weaving to convince police associations that better chemicals management will compromise their safety on the job?"

Denison wants some transparency from Householder. We don't know how/if Householder responded.

-----------------------------

Acronym Required has written extensively on BPA science and regulation. We also wrote about individuals hired by industry, the acrimony they stir up, and the possibility of wonderful relationships blossoming between players on either side of the chemical divide in BPA Rhetoric and Reaction

Sussing Out Friedman On Climate Change

In his most recent column, Thomas Friedman marshals ideas from Ron Suskind, Dick Cheney and Cass Sunstein in calling for action on climate change. By the end of his column, Friedman has reminded readers of decades of research showing that greenhouse gases make the planet warmer, with the "potential to unleash 'catastrophic' warming." Which risk should we take, he asks? Should we increase our efficiency and mitigation efforts, then in the unlikely event that climate change weren't critical, "as a country we would be stronger, more innovative and more energy independent"? Or should we risk not preparing, then if climate change were a catastrophe, "life on this planet" would become "living hell"?

Before we get to these arguments in "Going Cheney on Climate", though, you must grapple with Friedman's interpretation of Dick Cheney, Rons Suskind and Cass Sunstein. It's unclear why Friedman chose them, perhaps to convince the GOP, or any deniers, or those who are swayed by deniers, to support climate change action? Anyhow, using their ideas makes his argument confusing.

The One Percent Solution and Climate Change

Friedman refers to Ron Suskind's book "The One Percent Doctrine", titled after a comment Dick Cheney made in 2001:

"If there's a 1% chance that Pakistani scientists are helping Al Qaeda build or develop a nuclear weapon, we have to treat it as a certainty in terms of our response..."

That part Friedman gets right. But Suskind was actually extremely critical of Cheney and the "Cheney Doctrine". Why? Here's the rest of Cheney's comment:

"...It's not about our analysis, or finding a preponderance of evidence...It's about our response""

As Suskind wrote, Cheney's new world order demanded action despite evidence:

"Justified or not, fact-based or not, 'our response' is what matters. As to "evidence", the bar was set so low that the word itself almost didn't apply." If there was even a one percent chance of terrorists getting a weapon of mass destruction- and there has been a small probability of such an occurrence for some time -- the United States must now act as if it were a certainty. This was a mandate of extraordinary breadth...

Cheney's new US policy direction meant commitments from citizens and libraries as well as all levels of government -- the the CIA, the Army, the NSA, the Treasury. The costs were stupendous. As Suskind wrote:

"all parties took a vow of sorts on Sept. 12...vowed to work each day and every night...They'd stop at nothing...Global accords on everything from greenhouse gases to international courts...now were seen as constraints...Such agreements were for lesser countries. They were to be shaken off...

Suskind criticized the Cheney Doctrine precisely because its framers willfully disregarded evidence about the negligible risks of Al Queda gaining nuclear capability. They charged into war despite the evidence.

The situation with climate change is the opposite, the evidence for climate change is substantial. A cartoon in the Atlantic Constitution this week summarizes the folly of the deniers. A woman, speaking sometime in the future, says: "The North Pole melted. Polar bears are extinct. Asia's under water. Africa's a desert." The guy next to her responds: "Hey I never said the global warming hoax wasn't elaborate."

Adding to the confusion of Friedman's line of persuasion, the Cheney Doctrine leaves no doubt about that administrations sentiments on climate change, since according to Suskind the US took greenhouse gases off the negotiating table under the Cheney Doctrine.

Friends or Foes? Friedman's Folly

In addition to Suskind and Cheney, Friedman pulls in Cass Sunstein to wrap it all up, saying

"Sunstein wrote in his blog: 'According to the Precautionary Principle, it is appropriate to respond aggressively to low-probability, high-impact events -- such as climate change. Indeed, another vice president -- Al Gore -- can be understood to be arguing for a precautionary principle for climate change (though he believes that the chance of disaster is well over 1 percent)."

Here, Sunstein was actually criticizing the Precautionary Principle, and by extension the Cheney Doctrine, and most likely Cheney and company would bristle at being compared to Gore. According to Sunstein the Precautionary Principle muddles and stalls appropriate action on climate change. ideas he spelled out in papers, articles and books like Laws of Fear: Beyond the Precautionary Principle", and "Risk and Reason: Safety, Law, and the Environment", his 2002 book.

Sunstein uses social science research to show that individuals are susceptible to faulty conclusions based on irrational fear and errors in judgement like "availability heuristics". Sunstein argues that instead of the Precautionary Principle, the risks and benefits of action on suspected perils should be evaluated empirically. On global warming, he suggests cap-and-trade agreements and incentives to motivate players to make choices to limit emissions, rather than regulation. In a 2008 Boston Globe essay, Throwing Precaution to the Wind, Sunstein specifically uses the example of Bush's Iraq War as a precautionary tale for dealing with global warming:

"the Bush administration justified the war on explicitly precautionary grounds - that even the possibility of a nuclear-armed Iraq was so threatening that it demanded action. Indeed, the idea of "preemptive war" articulated by President Bush is a kind of precautionary principle. The nation went to war on the chance that Saddam Hussein had weapons of mass destruction. But this precaution is imposing a heavy price and creating serious risks for the future."

Sunstein warns against regulation, saying that regulation can invoke unforseen risks or even death -- banning DDT he says caused deaths from malaria -- a spurious argument, but one he uses along with others to warn people off the Precautionary Principle.

The "Cheney-Thing" on Climate - Something to Get Behind?

In the end, Friedman says:

"When I see a problem that has even a 1 percent probability of occurring and is "irreversible" and potentially "catastrophic," I buy insurance. That is what taking climate change seriously is all about.""

Cheney might use the one-percent argument to go to war, but he did so to invoke fear in the American public in order to gain their support. Suskind did not support the Cheney Doctrine, because it wasn't based in evidence and fact. Sunstein also criticized the Cheney Doctrine, comparing it unfavorably to the Precautionary Principle. Now Friedman incongruously corrals the whole mix to support: "doing the Cheney-thing on climate -- preparing for 1 percent." I'm not sure quite what to make of this kind of endorsement.

Higher Pollution from Alberta Tar Sands

Alberta Tar Sands

Last year we reported that the Alaskan gas pipeline, touted as necessary for American energy independence, would actually be transporting a lot of the gas to Canada's Alberta tar sands", where the gas would fuel oil extraction from bitumen, an energy intensive, elaborate process for getting oil. The oil will eventually help fuel US needs.

Extracting oil from the tar sands is difficult, expensive, and dirty.1 But as oil becomes scarcer and more expensive, extraction from the tar sands becomes a more economical option. Bitumen production increased from 482,000 barrels in 1995, to 1.3 million barrels a day in 2008, and is expected to reach 2 to 2.9 million barrels a day by 2020.2 Extraction operations increased in area to 530km2 (205mi2) in 2007.

Now a study from University Alberta released in the online Proceedings of the National Academy of Sciences (PNAS), finds that the tar sand extraction projects are dirtier than thought.2 Previous surveys done by the industry found that the tar sand operations didn't increase downstream levels of polycyclic aromatic compounds (PACs) -- chemicals (some carcinogenic) released both naturally and through mining operations.

Schindler et al independently investigated water pollution from the tar sands. Testing water from the Athabasca River, Lake, Delta and tributaries, their findings contradict previous studies by showing increased PACs. The authors found that the levels of polycyclic aromatic compounds (PACs) are higher downstream of mining activity, and greater in the summer than winter months. They also sampled snowpack, where they found significant particulate deposits.

Currently, the industry monitors itself, and the Alberta government somewhat audits the reports. Schindler observed to the journal Nature 3 what many recognize as problems with industry self-monitoring, it's "sort of like abolishing the police and asking people to pull over if they see they're speeding and report themselves." The PNAS authors recommend that the federal government take over monitoring pollution from the bitumen extraction operations.

Reports of like this are bad news to some Canadians who are worried about impressions and bad publicity around the tar sands, especially with the increased international attention due to Copenhagen. As University of Alberta energy economist Joseph Doucet put it: put it, "God help us if this becomes like baby seals."

-----------------------

1 To get a sense of it, I recommend Elizabeth Kolbert's article in the New Yorker, "Unconventional Crude."

2 Schindler DW et al "Oil sands development contributes polycyclic aromatic compounds to the Athabasca River and it tributaries" Proceedings of the National Academy of Sciences www.pnas.org/cgi/doi/10.1073/pnas.0912050106

3 Jones, N. "Tar sands mining linked to stream pollution" Nature www.nature.com | doi:10.1038/news.2009.1127

When "Effective EPA" is No Longer an Oxymoron?

The Environmental Protection Agency (EPA) finalized the agency's finding last April that greenhouse gases "(GHGs) endanger public health and welfare. Jackson reminded viewers that the Bush administration EPA had found that greenhouse gases endangered health and welfare, action compelled by the 2007 Supreme Court ruling in Massachusetts v. EPA, but had "regrettably" stalled on moving forward with the agency's recommendation offering only "excuses" and "delay". Said Jackson: "this administration will not ignore science or the law any longer, nor will we avoid the responsibility we owe to our children and grandchildren."

Having finalized the Endangerment Finding, Jackson announced some first steps:

"Next month, large emitters in the U.S. will begin working with EPA to monitor their emissions. Beginning in 2011, large emitters will - for the first time - submit publicly available information that will allow us to meaningfully track greenhouse gas emissions over time....And starting next spring, large emitting facilities will be required to incorporate the best available methods for controlling greenhouse gas emissions when they plan to construct or expand."

The agency noted that it had no intention of putting burdens on small businesses.

The Indefensible Status Quo and Republicans Think They're Deep Throat(?)

Last weekend we wrote about a group of GOP Republicans who asked the EPA to withdraw the Endangerment Finding because of the CRU emails. We noted their tone of desperation, for instance that they tried to make their case by quoting an infamous, non-sensical UK climate denier. Jackson addressed the skeptics, and noted that the EPA's action was based on decades of research.

"We know that skeptics have and will continue to try to sow doubts about the science. It's no wonder that many people are confused. But raising doubts - even in the face of overwhelming evidence - is a tactic that has been used by defenders of the status quo for years. Those tactics have only served to delay and distract from the real work ahead, namely, growing our clean energy economy and freeing ourselves from foreign oil that endangers our security and our economy."

True to form, last week Representative James Sensenbrenner(R-WI) had said that CRU emails were "evidence of scientific facism". Today, having worn out facism, communism and nazism and Hitler references, EPA letter writer Representative Richard Issa (R-CA) summoned fellow Republican the deceased Richard Nixon for his incoherent campaign. Responding to Jonathan Pershing's (U.S. deputy special envoy for climate change) observation that the emails were inconsequential and the science on climate change was "incredibly robust", Issa declared: "Richard Nixon said that about what Deep Throat had outed about the break-in."

Green Jobs, Pragmatism and Details

Jackson noted that today's action would also assure the American people, scientists, and the world that the EPA is serious, after eight years of inaction, about acting on the challenge of climate change. She hoped that recent EPA action would restore the "credibility and the trust of the American people" by taking an "enduring" and "pragmatic"

"step[s] towards innovation, investment and implementation of technologies that reduce harmful emissions...green jobs, reduced dependence on foreign oil, and a better future for our children."

These are great steps for the EPA, although we recognize the devil is in the details. Just as the work wasn't over once Obama won the election, the work isn't over now that the waiver is finalized.

September 2010

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