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Re: Why CDC Responded With “Lack of Urgency” to Formaldehyde
Posted by Myco X on 10/06/08
Sounds like there is an ongoing need for remedial math in the HHS and their
consultancies.
As Chris Rock said, "I asked my niece what 4 + 4 was. She answered, 44!"
I guess it's all in how you pose the question?
Myco
On 10/05/08, Sharon wrote:
> http://feeds.propublica.org/propublica/health-science
>
>
>
> The Centers for Disease Control study (PDF) sounded
> reassuring when it was made public in 2007. Hurricane
> Katrina survivors didn't have to worry about reports that
> there were harmful levels of formaldehyde in their
> trailers. The air was safe to breathe and the contamination
> would not reach a "level of concern" as long as they kept
> the windows open.
>
> Today, senior CDC officials acknowledge that the study was
> based on a fundamental error.
>
> An agency standard says that people exposed to as a little
> as 30 parts of formaldehyde per billion parts of air (ppb)
> for more than two weeks can suffer constricted airways,
> headaches and rashes. The trailers all measured above that
> level.
>
> But the scientists who conducted the study used a much
> higher agency standard to evaluate the formaldehyde in the
> trailers: instead of 30 parts per billion, they said health
> dangers wouldn't occur until the substance reached 300 ppb,
> 10 times greater than the long-term standard. According to
> the CDC, people exposed to that amount for just a few hours
> can suffer respiratory problems and other ailments.
>
> The story of the Katrina survivors and the trailers has
> been told many times in Congressional hearings and in the
> media. But it has been unclear until now why government
> officials continued reassuring residents the trailers were
> safe, at least a year after they should have been warning
> them to get out.
>
> A reconstruction of how CDC and other government agencies
> handled the formaldehyde problem, drawn from documents,
> interviews and a new congressional report (PDF), suggests
> that top government officials were worried from the
> beginning about lawsuits by the people living in the
> trailers. Communications among government agencies broke
> down, so much so that the CDC wasn't aware that other
> government agencies were continuing to rely on a flawed
> study.
>
> CDC’s reaction to the formaldehyde problem was “marred by
> scientific flaws, ineffective leadership, a sluggish
> response to inform trailer residents of the potential risks
> they faced, and a lack of urgency to actually remove them
> from harm’s way,” concludes the 40-page report, scheduled
> to be released this week by Democrats on the Science and
> Technology Committee’s subcommittee on investigations and
> oversight for the U.S. House of Representatives.
>
> The report also chronicles the futile efforts of
> Christopher De Rosa, a senior CDC toxicologist, to warn top
> officials of another problem with the 2007 study: It failed
> to mention that formaldehyde can cause cancer.
>
> Other clues were found by ProPublica, an investigative
> journalism organization based in New York City, which
> examined hundreds of pages of e-mails and other documents
> and interviewed former and current CDC scientists and
> officials.
>
> The story that emerged is of a government bureaucracy that
> remained silent as the formaldehyde crisis mounted,
> straying from its mission to serve the public by "providing
> trusted health information to prevent harmful exposures and
> disease related to toxic substances."
>
> Joe Little, one of the ATSDR scientists who conducted the
> study, said they chose the higher 300 parts per billion
> standard because it is the lowest level that is likely to
> cause a health "effect." The 30 ppb level, he said, is
> a "risk" level, meaning that illness is less certain. "Risk
> and having an effect are two different things," he said.
>
> A year after the CDC issued its first study, it conducted
> new tests in occupied trailers. The results were clear.
> Formaldehyde levels surpassed 100 ppb -- more than three
> times the 30 ppb standard for year-long exposure -- in 41
> percent of the trailers tested.
>
> "It would be wise for people to be relocated" from the
> trailers before summer, CDC director Julie Gerberding said
> in a prepared statement to the media on Feb. 14, 2008.
>
> A CDC official later told Congress that he should have
> noticed that the first study used the wrong standard.
>
> “I believe everybody who reviewed that document had the
> opportunity to see that, and we missed that,” said Tom
> Sinks, deputy director of the CDC’s Agency for Toxic
> Substances for Disease Registry, or ATSDR.
>
> Early warnings, delayed testing
> Katrina survivors started complaining about the air in
> their trailers almost as soon as they began moving into
> them, in the fall of 2005. Formaldehyde was quickly
> pinpointed as a possible cause, because it's often in the
> glue used to make plywood and particleboard, which are
> found in most trailers.
>
> Some people described an almost overpowering "new car
> smell" in the trailers, which were supplied to them by the
> Federal Emergency Management Agency. Paul Nelson, who moved
> into a FEMA trailer that September, described it as "kind
> of a musky smell, but it burns your eyes and sinuses."
>
> "It gives you excruciating headaches," he said.
>
> By April 2006, complaints from trailer occupants had grown
> so loud that the Sierra Club stepped in and tested dozens
> of units. It found levels as high as 340 ppb in some of the
> trailers, more than 10 times the amount considered safe for
> long-term exposure.
>
> FEMA employees working in the hurricane area asked for
> government testing. But the agency's lawyers initially
> resisted. Documents obtained by the House Committee on
> Oversight and Government Reform show that litigation was a
> major concern.
>
> "While I agree that we should conduct testing we should not
> do so until we are fully prepared to respond to the
> results," FEMA attorney Rick Preston said in an e-mail
> (PDF) to another FEMA employee. "Once you get results, and
> should they indicate some problem, the clock is running on
> our duty to respond to them."
>
> In a series of conference calls (PDF) that began in June
> 2006, FEMA's lawyers discussed the problem with
> representatives of the Environmental Protection Agency and
> the Agency for Toxic Substances for Disease Registry, a
> little-known division of the CDC that studies how
> environmental hazards can harm people. One of the ATSDR
> scientists on the calls later told congressional
> investigators, "To say initially it was a P.R. problem is
> probably accurate."
>
> In September and October of 2006, the EPA gathered air
> samples in 96 unoccupied trailers. According to an email
> written by a participant on the conference calls, an EPA
> official warned that formaldehyde levels in the units might
> turn out to be "far above" the acceptable level "even after
> we ventilate them."
>
> Preston told ATSDR to analyze the samples.
>
> But the instructions given to the two ATSDR scientists
> assigned to the task -- Joe Wright and Scott Little --
> seemed odd. FEMA told them to establish "a frame of
> reference," not to assess the actual health consequences,
> Little told ProPublica.
>
> When Preston gave the samples to Wright and Little, he
> attached a letter saying, "No information should be
> released to any third party without my express permission."
>
> FEMA did not respond to ProPublica's questions on the
> trailers.
>
> It referred ProPublica to previous news releases in which
> the agency denied influencing the CDC study.
>
> Mistaken standards
> One of the first things Wright and Little had to do was
> decide how much formaldehyde was too much.
>
> Federal agencies use more than half a dozen different
> formaldehyde standards for different segments of the
> population, creating confusion for lawmakers,
> manufacturers, the public and the agencies themselves.
>
> ATSDR itself recommends several standards, including the 30
> ppb standard suggested for people exposed to formaldehyde
> regularly for up to a year, and the 300 ppb standard Wright
> and Little chose. The higher standard is intended as a
> guide for physicians treating patients exposed to
> formaldehyde during a chemical spill or other emergency.
>
> The scientists bolstered their choice of 300 ppb by saying
> that is the standard recommended by the American Conference
> of Governmental Industrial Hygenists. But the group's
> chairman, Dr. Terry Gordon, said 300 ppb is intended to be
> a guide for the maximum amount of formaldehyde that a
> worker should ever be exposed to for any period of time.
>
> "They should not have applied a worker ceiling limit to 24-
> hour, around the clock living," said Gordon, whose
> organization is comprised of industrial hygienists
> throughout the nation.
>
> The samples Little and Wright analyzed came from two sets
> of unoccupied trailers: one with all the windows and vents
> open, and the other with the air conditioning running and
> the bathroom vent open. The report (PDF) found that if all
> the windows and vents were left open for four days, the
> average formaldehyde levels fall beneath 300 ppb, although
> they were still above 30 ppb. But in the set with the air
> conditioning running and the bathroom vents open,
> formaldehyde levels dropped beneath that threshold on only
> two days of the 14 day study.
>
> Glen Nowak, a CDC spokesman, emphasized that FEMA hadn't
> asked ATSDR to analyze the impact of the trailers' air on
> public health. Despite the publicity swirling around the
> trailers at this point, he said he didn't think Little and
> Wright knew people would be moving into the trailers they
> were testing.
>
> Vincent Garry, director of environmental medicine at the
> University of Minnesota, read Little's and Wright's report
> at the request of the subcommittee and told ProPublica
> he "found it to be naïve."
>
> In a letter (PDF) requested by the subcommittee, Garry, who
> peer-reviewed ATSDR's guidelines on formaldehyde exposure,
> said the report did not "take into account that unlike
> occupational exposures this is a 24 hr per day 7 days per
> week exposure for children and the old who are sensitive to
> the chemical for different reasons."
>
> "I think the report gave us what we were looking for"
> In early 2007 a draft of the ATSDR report went to the
> office of Howard Frumkin, ATSDR's director, where Wright
> and Little said it was revised at least four times.
> Wright's handwritten notes obtained by the subcommittee
> show that Sinks, ATSDR's deputy director, made numerous
> comments. But nobody questioned the 300 ppb standard or the
> absence of any mention of formaldehyde’s link to cancer.
>
> Preston, the FEMA lawyer, received the report on Feb. 1,
> 2007 with a cover letter (PDF) from Little and Wright
> summing up their findings: opening windows and vents would
> bring formaldehyde levels "below levels of concern."
>
> The two scientists assured Preston they hadn't shown the
> letter to anyone else and "as requested" they did not
> evaluate "health concerns related to potential exposures."
> They also warned him that the report was "not intended to
> establish FEMA's future policy concerning temporary units."
>
> Almost immediately, however, FEMA employees began using the
> report to tell occupants that the formaldehyde did not pose
> a health threat.
>
> "Thanks, Rick, I think the report gave us what we were
> looking for," said an emergency management program
> specialist said in an e-mail (PDF) to Preston 11 days after
> the report was delivered. "Changing air via external
> venting is effective in reducing the formaldehyde levels."
>
> A month later, a FEMA trailer maintenance coordinator, told
> staff in an email (PDF) that FEMA would use 300 ppb "as a
> guide in our housing program."
>
> A whistleblower ignored
> The report by Wright and Little showed up on Christopher De
> Rosa’s desk on February 27, 2007, nearly four weeks after
> it went to FEMA. Throughout his 17-year career with the
> CDC, De Rosa had received positive performance evaluations.
> A few months earlier, however, his bosses had criticized
> his work on two controversial projects, one on industrial
> waste in the Great Lakes and the other on a cancer-causing
> chemical found in some cosmetics.
>
> Although Little and Wright normally reported to De Rosa,
> they told the subcommittee they sent all their Katrina work
> directly to Frumkin's office because they were following a
> new chain of command Frumkin had developed to get those
> reports out faster. But Frumkin told ProPublica that the
> scientists still should have sent the report to De Rosa.
> And Frumkin told Congress that De Rosa had missed several
> opportunities to be more involved in the study.
>
> When De Rosa skimmed the report, he immediately called
> Sinks, ATSDR's deputy director.
>
> The report downplayed the health risks, he told Sinks,
> because it omitted the long-term and potentially cancer-
> causing effects of formaldehyde exposure. He repeated his
> warning in an email to Sinks and Frumkin that day and
> attached a letter that he suggested sending to Rick
> Preston, the FEMA lawyer who had asked ATSDR for the
> report. It said that "failure to communicate this issue is
> possibly misleading, and a threat to public health."
>
> De Rosa told Congress he was so alarmed by those omissions
> that he missed the more serious flaw in the 12-page
> document: that it used the wrong safety standard.
>
> When De Rosa hadn't heard from Frumkin or Sinks a week
> later, he sent them another email (PDF). If he didn't hear
> otherwise by the end of the next day, he told them he would
> notify FEMA of the report's flaws himself.
>
> A month later, De Rosa's letter made its way to Preston,
> the FEMA lawyer. But Preston told the subcommittee he stuck
> the letter in a file and never shared it with anyone. He
> also told Congress he had never told Wright and Little not
> to study the health effects of formaldehyde in the
> trailers.
>
> "Everything in that letter was already known to FEMA," he
> told subcommittee investigators. Preston has since left
> FEMA and could not be reached for comment.
>
> Not long after Preston put the warning in his file, FEMA
> began drafting a news release announcing the results of
> ATSDR's study. As FEMA staffers scrutinized the release,
> one of them spotted a problem.
>
> "I guess I'm a little concerned about this paragraph. [300
> ppb] is high according to information available to the
> public," the employee said in an email (PDF) to his
> colleagues, pointing to the 300 ppb standard used by ATSDR.
> This is “high according to information available to the
> public.” In a follow-up email he listed the much lower
> standards made public on Web sites from other agencies.
>
> But FEMA decided to release the report anyway.
>
> For the next several months, FEMA officials – including the
> agency's chief, R. David Paulison, and its press spokesman,
> Aaron Walker – assured the public that the trailers were
> safe as long as the windows were kept open.
>
> "We have no need, and we see no need, to question the
> reliability and safety of the trailers," Aaron Walker told
> the media on May 10, 2007.
>
> "We've been told that the formaldehyde does not present a
> health hazard," Paulison told Congress at a May 15 hearing
> (PDF).
>
> Less than a week after the hearing, an ATSDR employee sent
> Frumkin an email that included a link to a FEMA press
> release announcing that ATSDR had said formaldehyde levels
> were beneath the “level of concern” if the windows were
> open. On May 30, Frumkin received another email from
> someone outside the agency that included a copy of a story
> quoting Paulison making a similar assurance.
>
> But ATSDR didn’t notify FEMA that it was still using the
> flawed study, even though Frumkin received several emails
> mentioning FEMA's public statements.
>
> “I was not aware of how FEMA was using the information in
> our report until the middle of ’07,” Frumkin told
> ProPublica. “We really don’t and can’t routinely monitor
> what other agencies and organizations say or do with our
> information.”
>
> Barry Johnson, who ran ATSDR in the 1990s, told ProPublica
> his staff regularly updated him on media coverage of health
> studies like the one produced by Wright and Little. "We
> were able to track the impact of those consultations
> closely," he said.
>
> Frumkin also said FEMA’s public statements didn’t come up
> in the weekly meetings he held with his top staff. Yet
> documents show references to FEMA trailers, formaldehyde,
> or news reports about the issue on more than a dozen
> meeting agendas between January and July 2007. Frumkin said
> those discussions focused only on an inquiry from a
> Mississippi congressman about formaldehyde complaints from
> trailer occupants in his district.
>
> A former high-level CDC employee, who asked not to be named
> because the individual still does business with the agency,
> told ProPublica that the CDC normally keeps close tabs on
> the media, including Web searches for relevant news.
>
> The former employee said Sinks and Frumkin are genuinely
> dedicated scientists, but that getting the CDC to admit it
> made a mistake would be extremely difficult, because the
> agency is hobbled by top-heavy, overly cautious management.
>
> “The agency as a whole should have stepped in,” the former
> official said.
>
> Unsatisfactory performance
> It wasn’t until July 19, 2007 that Congress and the public
> learned that FEMA had been using flawed information to
> assure trailer occupants the trailers were safe.
>
> Mary DeVany, an industrial hygienist, was called in as an
> expert witness by the House Oversight and Government Reform
> committee, which was holding hearings on FEMA’s response to
> the formaldehyde issue.
>
> She testified that ATSDR had “arbitrarily” chosen the 300
> ppb limit “and applied this high level to the results as if
> it were a safe and applicable limit,” said DeVany, who has
> spent much of the last three years testing the trailers for
> a lawsuit against the trailer manufacturers. She told
> ProPublica that her company’s employees’ constant exposure
> to the chemical has left some of them suffering the same
> ailments as the trailer residents.
>
> After that hearing, Frumkin, Sinks and other top CDC
> officials began talking about doing more tests.
>
> But De Rosa thought immediate action should be taken. He
> sent another e-mail (PDF), this time addressing it to CDC
> officials as well as to his bosses at ATSDR.
>
> Yes, more testing was needed, he said. But what was being
> done in the meantime to make the trailer occupants safe?
>
> "I am concerned that the reported clinical signs are a
> harbinger of an impending public health disaster," he said
> in the July 24, 2007 message.
>
> Mike McGeehin, director of the CDC's division of
> environmental health hazards, answered De Rosa in an e-mail
> (PDF).
>
> "The type of data on which to base a decision whether to
> uproot 66,000 families is lacking," McGeehin wrote. He
> asked De Rosa to discuss future concerns over the phone or
> in person. "Emails can be interpreted so many ways by
> different readers inside and outside the agency," McGeehin
> said.
>
> On Aug. 10, 2007, Gerberding, the CDC director, echoed De
> Rosa's concerns in an e-mail (PDF) to Frumkin. "I realize
> that good science takes time, and good regulations can take
> an eternity," she said. "But in the meantime, this issue is
> festering, and these people are suffering."
>
> By then De Rosa's career with the CDC was crumbling.
>
> In October, he and Frumkin attended a conference for the
> Collegium Ramazzini, a body of 180 recognized experts in
> occupational and environmental health. It was held in
> Carpi, Italy. De Rosa took along his father, who is Italian
> and had never been to Italy.
>
> At an awards ceremony during the conference, Frumkin walked
> over to De Rosa and his father and handed the toxicologist
> an unsatisfactory performance evaluation, the first in his
> 27-year government career. A memo (PDF) attached to the
> performance evaluation told him he was being reassigned.
>
> When questioned about De Rosa's status, Frumkin told
> Congress that "the reassignment of Dr. De Rosa was not in
> any way a retaliation for his actions in this case. His
> reassignment was a result of personnel actions that are
> best not discussed in a public forum like this."
>
> Several former and current CDC scientists interpreted De
> Rosa's reassignment as a message that CDC employees should
> be wary of criticizing CDC projects.
>
> Susan Kess, a former senior medical officer in ATSDR's
> division of toxicology, who left the agency in 2005, said
> that by removing De Rosa from his position, "They are
> squelching scientific integrity within the agency, and that
> is an injustice to the public."
>
> De Rosa is now contesting his reassignment in mediation
> hearings.
>
> Two years later, risk officially revealed
> In December 2007 and January 2008, two years after FEMA
> trailer occupants had begun complaining about burning eyes
> and labored breathing, the CDC conducted the federal
> government's first formaldehyde tests on trailers where
> people were actually living.
>
> In February the CDC announced that preliminary results
> showed the formaldehyde levels in many of the trailers were
> high enough to increase the risk of cancer and respiratory
> illnesses. FEMA began urging people to move out.
>
> The CDC has asked its independent Board of Scientific
> Counselors to investigate how the flawed formaldehyde
> report slipped through the agency's bureaucracy. The agency
> also has agreed to study how the children who lived in FEMA
> trailers may have been affected by their exposure to
> formaldehyde.
>
> More than 100,000 of the trailers now sit, unused, at sites
> throughout the country.
>
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