This is from the Pump Handle blog. So far, all of the attention has been on workers. This is the
first case identified of a consumer getting popcorn lung by popping
popcorn in his own kitchen. He probably popped a lot more popcorn
than
the average person, but two questions remain:
1. Is this a single case, or is it just the first (of many)
identified
cases that family physicians may have been overlooking?
>>>>>Aren't these the same questions we've been asking over the
years? But the only difference is is that we are dealing with a
natural toxin vs a man made one, but at a much greater magnitude with
more severe debilitating effects.
2. Where are our public health agencies. Even if this is an isolated
case, shouldn't it have launched further inquiries and alerts?
>>>>Good question.... Why haven't they?
And finally, will this help the case for an OSHA standard?
>>>>Well, duh!!! You would think so and we already have it laid out
for them, such as the S520. We've done their work for them and they
still don't take notice. How more lives have to be ruined!
Popcorn Lung Coming to Your Kitchen? The FDA Doesn't Want to Know
http://thepumphandle.wordpress.com/2007/09/04/popcorn-lung-coming-to-
your-kitchen-the-fda-doesnt-want-to-know/
Tuesday, September 4th, 2007 in Flavoring Workers' Lung, Regulation,
Politics, Health by David Michaels
By David Michaels
For the past several years, news articles and Congressional hearings
have reported on a deadly, irreversible lung disease - bronchiolitis
obliterans - that is caused by workers' exposure to food flavoring
chemicals, and more specifically by exposure to a butter-flavoring
chemical called diacetyl. So far, attention has focused on worker
exposure, rather than on possible health problems affecting consumers
who pop popcorn in their microwave ovens. That focus may be changing,
however, with a warning sent by one of the country's leading lung
disease experts.
The CDC, FDA, OSHA, EPA - federal agencies charged with protecting
public health - each received a letter in July alerting them to the
possible serious respiratory hazard to consumers who breathe in fumes
from their artificially butter-flavored microwave popcorn. The
warning
should have resulted in some action by these agencies, but instead,
they've done virtually nothing.
It appears that the Bush Administration's efforts to destroy the
regulatory system are succeeding; the agencies seem unable to mount a
response to information that a well-functioning regulatory system
would immediately pursue. The agencies aren't even trying to connect
the dots.
In July, Dr. Cecile Rose the chief occupational and environmental
medicine physician at National Jewish Medical and Research Center,
the
most prestigious lung disease hospital in the country, wrote to the
FDA, CDC, EPA and OSHA, informing the agencies of a patient she had
recently identified
"with significant lung disease whose clinical findings are similar to
those described in affected workers, but whose only inhalational
exposure is as a heavy, daily consumer of butter flavored microwave
popcorn."
This letter is a red flag, suggesting that exposure to food flavor
chemicals is not just killing workers, but may also be causing
disease
in people exposed to food flavor chemicals in their kitchens.
In the last seven years, dozens of workers have developed the rare
and
sometimes fatal disease bronchiolitis obliterans (BO) - also known as
"popcorn lung." The sick workers were employed in factories where
diacetyl, the primary ingredient in artificial butter flavor, was
manufactured or applied to food. Most of these cases have been seen
in
microwave popcorn factories. Last week, one of the country's largest
popcorn makers announced it was eliminating diacetyl from its butter
flavor.
Since I first wrote about the failure of OSHA to protect food
industry
workers from this deadly exposure, I have been asked by dozens of
reporters whether it is safe to pop microwave popcorn at home. I
explain that there is no evidence that it is dangerous to breathe the
chemicals that come out of popcorn bags after they are microwaved,
but
that the issue has not been studied, so I can't say that it is safe.
My colleagues and I at the Project on Scientific Knowledge and Public
Policy have been doing our best to push the relevant federal agencies
into investigating the problem.
We have not been alone. In the last year, the question of consumer
exposure has come up in countless media reports and several
congressional hearings, and a powerful member of Congress has raised
the issue directly with the Commissioner of the FDA.
Given this background, one would expect the relevant federal agencies
to respond quickly to what may be the first documented case of lung
disease caused by consumer exposure to artificial butter flavor. What
we are faced with, however, is a failure of those agencies to take
action, a sign that something is seriously wrong with our public
health system. The letter from Dr. Rose should have been sufficient
to
raise concerns at the agencies involved. There are few physicians in
the country who have more experience with lung disease caused by food
flavor chemicals than Dr. Rose; she has been a consultant to the
Flavor and Extract Manufacturers Association (FEMA) - the association
of companies that make food flavorings - for more than a decade and
helped develop the industry's Respiratory Safety Program.
Later in this post, I detail the response of each agency. First, it
is
worth looking at Dr. Rose's letter, in which she described the ways
in
which this patient's condition resembled that of the workers who
developed lung disease after exposure to flavor chemicals, and the
reasoning that went into her decision to alert the regulatory
agencies:
1. The patient described progressively worsening respiratory symptoms
of cough and shortness of breath. Extensive medical, occupational and
environmental history taking did not reveal a known cause for these
symptoms. The patient did report daily consumption of several bags of
extra butter flavored microwave popcorn for several years.
2. Serial pulmonary function testing revealed progressively
worsening
fixed airflow limitation without a bronchodilator response and with a
normal diffusion capacity for carbon monoxide. This is the pattern of
lung physiologic abnormalities described in affected workers.
3. High resolution chest CT scan showed bronchial wall thickening,
bronchiectasis, mosaic attenuation and expiratory air trapping. This
appearance is similar to the imaging abnormalities reported in
affected microwave popcorn factory workers.
4. Lung biopsy showed diffuse hyperinflation, a relative absence of
small airways, and bronchioles in various stages of obliteration,
findings of bronchiolitis obliterans (BO).
5. The patient's clinical course has been consistent with that
described in microwave popcorn factory workers with BO, with a
progressive decline in FEV (Forced Expiratory Volume in the first
second, a marker of airflow obstruction) despite treatment with oral
corticosteroids. His lung function appears to have stabilized
recently
with cessation of exposure to butter flavored microwave popcorn.
6. We measured airborne levels of diacetyl during microwave popcorn
preparation in the patient's home and found levels similar to those
reported in the microwave oven exhaust area in the quality assurance
unit of the microwave popcorn manufacturing plant where affected
workers were initially described.
This letter represents more than the report of a single isolated case
of BO in a person who happens to eat a lot of extra-buttery microwave
popcorn. The report comes after years of evidence that diacetyl
causes
BO in workers at factories where the chemical is produced, mixed and
applied to food products. We don't know, in other words, whether this
is an unfortunate coincidence or the first identified case of BO
among
popcorn consumers. It is possible that there are other people who
have
BO or another, less severe diacetyl-caused obstructive lung disease,
but who are being treated by their own personal physicians who do not
have Dr. Rose's expertise and familiarity with the outbreak of BO in
food industry workers. Are there more cases out there? We don't know,
but now is the time to find out.
In her letter, Dr. Rose acknowledged that it is difficult to make
judgments based on a single case, but, given "the public health
implications" of the possibility this patient's illness was caused by
his exposure to butter flavor chemicals at home, she did what any
dedicated public health practitioner would do: she notified the
agencies that are supposed to protect the public health.
And that's where things seen to have stopped.
The receipt of Dr. Rose's letter is the moment where the FDA, or the
CDC, should have said "Whoa! Here is an indication that the problem
may go beyond workplaces." The agencies have never looked for BO
cases
among people who are heavy consumers of popcorn at home, but now they
could issue an alert, requesting information from lung disease
specialists around the country. Or they could have called a meeting
of
the technical directors of the popcorn manufacturers to learn about
what they know about consumer exposures, especially about the levels
of diacetyl released when popcorn with extra butter flavor is popped
in a microwave oven. ( Documents released by the EPA suggest that
ConAgra, manufacturer of the Orville Redenbacher brand, may know
quite
a lot). At minimum, they could have asked Dr. Rose for more
information.
None of the agencies did anything like this. In fact, their failure
to
respond adequately is a sign that our public health protection system
is in dire need of repair .
Here's a brief review of what each agency is doing (or not doing)
about food flavor chemicals, and, according to Dr. Rose, how they
responded (or didn't respond) to the letter.
1. The Food and Drug Administration (FDA)
The FDA has been asked several times to examine whether breathing
diacetyl poses a risk to consumers. Each time, the agency has
refused.
Last September, SKAPP petitioned the FDA to remove diacetyl from the
"Generally Regarded As Safe" (GRAS) list, pointing out that " there
is
compelling evidence that breathing diacetyl vapors causes lung
disease
and there is no evidence of a safe exposure level. " In March 2007,
the FDA wrote us back, essentially blowing us off.
Then, in May 2006, Congresswoman Rosa L. DeLauro (D-CT), chair of the
House of Representatives Appropriations subcommittee that funds the
FDA, urged the agency "to consider revoking the generally safe
designation for diacetyl and removing it from the market until
further
testing is completed." FDA Commissioner von Eschenbach refused to
commit the FDA to do anything other than monitor the situation, and
there is no evidence they are even doing this.
Frustrated by the FDA's continued failure to take action, Rep.
DeLauro
added language to the report that accompanied the Agriculture
Appropriations Bill, directing the FDA to submit a report on its
diacetyl research plan to the committee within 90 days of enactment.
What did the FDA do when it received Dr. Rose's letter in July?
According to Dr. Rose, FDA attorneys asked that she resubmit her
letter to the docket that has been created for our petition, since
evidently, the FDA the office to which the letter was sent didn't
feel
they could do it themselves. (This is the reason the letter is dated
July 18th but date stamped August 21, the day it was entered into the
docket).
2. The Environmental Protection Agency (EPA)
As readers of The Pump Handle know from repeated posts on the
subject,
some time in 2003, the EPA announced that a study on the chemicals
released in the popping and opening of packages of microwave popcorn
was underway and was expected to be completed by the end of that year
(2003). The results of that study still have not been released,
although the results have been shared with popcorn manufacturers.
In July, 2006, I wrote to EPA Administrator Stephen L. Johnson,
asking
for expedited release of the study and objecting to the preferential
treatment given to industry. The EPA responded that the study had
undergone internal and external review and would soon be sent to
industry "solely to ensure that no confidential business information
is released." The agency planned to submit the paper to a scientific
journal in fall 2006 and anticipated publication by mid-2007.
The scientific community and the public are still waiting for the
result. However, last week, the owner of one of the country's leading
popcorn manufacturers cited the EPA study as one of the reasons his
firm was now selling a butter flavor popcorn made without diacetyl.
What did the EPA do when it received Dr. Rose's letter in July?
According to Dr. Rose, the EPA thanked her and said it would treat
the
letter as a submission under section 8e of the Toxic Substances
Control Act. Under this law, the EPA collects and compiles reports on
adverse effects of chemicals. At one time, the agency promptly posted
them on its website so the reports could be read by interested
parties. But the EPA has evidently stopped posting - the last 8e
submission posted on the EPA website was submitted in June 2006. So
Dr. Rose's letter is apparently collecting dust in some large pile of
paper where it apparently remains, unlikely to be released to the
public for who knows how long.
3. The Centers for Disease Control and Prevention (CDC)
Although its mission is "to promote health and quality of life by
preventing and controlling disease, injury, and disability," the CDC
is not a regulatory agency. It does play a central role in
investigating the causes of illnesses and in alerting the public and
medical communities about ways to prevent diseases from occurring.
The National Institute for Occupational Safety and Health (NIOSH), a
branch of the CDC, has done terrific work investigating the causes of
lung disease among flavor workers.
As of last week, CDC had not responded to the letter.
4. The Occupational Safety and Health Administration (OSHA)
OSHA is charged with protecting the health of workers, so the
information in this letter wasn't particularly relevant to their
work.
Last July, two unions petitioned OSHA for a standard that would
protect workers from diacetyl exposure. Dozens of leading scientists
supported the petition.
The failure of OSHA to take even minimal steps in the face of a clear
and present hazard (dozens of sick workers in popcorn and flavor
factories) has been the subject of scathing newspaper articles and
editorials and two congressional hearings.
The House of Representatives will soon consider legislation, already
passed by the House Education and Labor Committee, requiring OSHA to
issue an emergency standard for diacetyl 90 days after the
legislation
is enacted. FEMA, the flavor industry's trade association, supports
the legislation .
The Bush Administration, needless to say, opposes the legislation,
and
there still is no indication OSHA is actually working on a standard.
The only sign of life so far out of OSHA was the recent announcement
of a "National Emphasis Program" aimed at popcorn factories. Given
that most new cases appear to be occurring in the factories that
produce the flavorings used in the production of popcorn and other
food products, this is simply too little too late.
Perhaps because Dr. Rose's letter did not contain any information
that
required OSHA to do anything (it was limited to a report on consumer
rather than worker exposure), OSHA evidently did respond promptly,
thanking Dr. Rose for her letter.
At one time, the US regulatory agencies were the envy of the world.
The agencies were staffed with the best scientists, who did their
best
to ensure that preventable diseases were actually prevented.
Sadly, much has changed. The newspapers are filled with reports of
political hacks running the agencies, over-ruling the decisions of
career scientists in order to protect perceived corporate interests.
The White House Office of Management and Budget has erected a series
of barriers impeding those agencies that still want to issue any new
measures that will protect the public from pollution and dangerous
products.
The anti-regulatory fervor of the Bush Administration is so great
that
agencies like OSHA will not step in to regulate even when it is
requested to by responsible industry, as in this case where the
flavor
industry is supports legislation that will force OSHA to issue a
diacetyl standard.
Sadly, the damage to the agencies has been severe. The anti-
regulation
policies coming from the White House and the political hacks running
the agencies have taken their toll. The agencies have fewer staff and
fewer resources. Morale is at its lowest. Many of the best scientists
have left and are not being replaced.
The public will pay the price, for many years to come. Repairing our
system of public health protection will be one of the most difficult
challenges faced by the next Administration.
David Michaels heads the Project on Scientific Knowledge and Public
Policy (SKAPP) and is Professor and Associate Chairman in the
Department of Environmental and Occupational Health, the George
Washington University School of Public Health and Health Services.
