Occ-Env-Med Announcement Forum

[Guest guest]

I thought you might find this a bit interesting and their concerns

or lack thereof of the workers and popcorn lung. They are asking the

same questions that we have been asking for years, but we have the

scientific research to back it up. >>>> below are my statements to

the questions.

KC

This is from the Pump Handle blog (which you should all be reading

daily.) 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 manmade 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 s

By s

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 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 L. ,

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.

s 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

Washington University School of Public Health and Health Services.

******************

[Guest guest]

I have tried to tell family members this one for years. No one listens.

>

> I thought you might find this a bit interesting and their concerns

> or lack thereof of the workers and popcorn lung. They are asking the

> same questions that we have been asking for years, but we have the

> scientific research to back it up. >>>> below are my statements to

> the questions.

>

> KC

>

>