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Post: Why CDC Responded With “Lack of Urgency” to Formaldehyde WarPosted by Sharon on 10/05/08
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.
Posts on this thread, including this one
Why CDC Responded With “Lack of Urgency” to Formaldehyde War, 10/05/08, by Sharon. Re: Why CDC Responded With “Lack of Urgency” to Formaldehyde, 10/06/08, by Myco X.
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