As I posted yesterday, OSHA has released a new (revived) National Emphasis Program on Microwave Popcorn. This new NEP expands the list of flavoring chemicals to be included in the inspection process – beyond just diacetyl. It’s not clear how they are taking what seems to be a leap of faith with the new studies and leveraging them into such a specific enforcement program.
There seems to be no empirical evidence mentioned in the new NEP which links substitutes with actual bronchiolitis obliterans in the absence of diacetyl. Further, OSHA also does not mention what the experimental exposure levels of these substitutes were for these recent animal studies. Typically, these levels are much higher than what might be found in a plant environment and, therefore, would be of limited use when setting safe thresholds for workers.
The basis for this new NEP seems to be elevated findings of shortness of breath and reported asthma-like symptoms that diminished once workers were removed from the exposure area. This seems inconsistent with the findings of irreversible obstructive lung disease associated with diacetyl that prompted the previous flavoring NEPs. In fact, this disconnect is further highlighted by OSHA’s apparent rush to enforcement on the heels of NIOSH’s recent RFI which seeks important information from stakeholders on the effects of substitutes on workers.
Perhaps if OSHA released the enforcement data from the first Microwave Popcorn NEP and the subsequent Food Flavoring NEP, stakeholders will better understand why the Agency is doing what it is doing. Without that data to shed more light on the issue, stakeholders will continue wondering if their efforts are actually protecting workers. When will OSHA publish these findings that contain necessary information for employers and employees to protect themselves?
Final thought: By focusing on the Microwave Popcorn industry for this NEP, is OSHA implying that these chemical substitutes are not a potential issue for the broader food flavoring industry? I doubt that was their intent but what signal are they trying to send?
Popcorn lung is a very serious issue. The only way to solve the problem, in my opinion, is to focus on sound science and making common sense recommendations for employers and employees to better protect themselves. Visit our other blog posts on Diacetyl and Popcorn Lung to learn more about how to become OSHA compliant.
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Prometrix Consulting, with a staff of former OSHA officials, offers expert consulting and training services to help clients ensure compliance with complex workplace safety and health requirements. These services include, in part:
Workplace Safety and Health Programs:
Prometrix experts can help you establish a workplace safety and health program that sets the foundation for OSHA compliance and worker protection. We can also review existing programs to ensure ongoing compliance with complex requirements.
Preparations for OSHA National Emphasis Programs (NEPs):
Our staff of former senior OSHA officials will conduct a thorough mock inspection consistent with NEP directives and Agency procedures to identify and address areas of vulnerability.
Action Planning for OSHA Citations:
Our staff will analyze your case, and if applicable, negotiate a settlement or help contest an unfair citation predicated on us also helping you implement corrective safety and health programs for continued compliance.
Contact us via http://prometrixinc.com/contact-us or info@prometrixinc.com regarding your OSHA compliance issues.
Follow us on Twitter: @Prometrix
Some helpful quick links:
OSHA Consulting, OSHA Consultants, OSHA Experts, Prometrix, Prometrix Consulting, OSHA Resources, OSHA Blog, Diacetyl, Diacetyl NEP, OSHA Diacetyl, DAPORS, DIACETYL SHIB.
This morning, OSHA issued a press release stating that it has revised the NEP on Diacetyl in Microwave Popcorn to include other flavorings and substitutes. This term (Diacetyl And Possibly Other Related Substitutes), DAPORS, was coined by ACOEM. This comes on the heels of OSHA releasing a new SHIB on Diacetyl and Subsititutes (DAPORS) last October and the announcement of the expanded rulemaking effort on Diacetyl and Food Flavorings. It was well known among insiders that a revised NEP, in some form, would likely be forthcoming. Well, this is it.
I am in the process now of reading through the OSHA NEP and press release in greater detail. The first thing that jumped out at me was this was specifically targeted for the Microwave Popcorn industry and not the food flavoring industry like the most recent NEP (which is still in effect, by the way).
WHY DIDN’T OSHA REVISE THE EXISTING NEP TO INCLUDE SUBSITITUTES INSTEAD OF THE EXPIRED MICROWAVE POPCORN NEP?
If Diacetyl and it’s substitutes are a hazard, and these substances are injuring workers in a multitude of industries as proclaimed in the SHIB and Rulemaking update in the Reg Agenda, and OSHA is serious about the problem … yes a lot of what-ifs … then why in the world would they take this narrow tact??? By (admittedly) first impression, this sends yet another mixed signal to the industry and stakeholder community that OSHA might be acting from the hip on this issue instead of taking a deliberate, practical, strategic approach.
In the mean time, see the press release pasted below or contact us directly for more information.
OSHA revises National Emphasis Program to focus on protecting workers from exposure to diacetyl and diacetyl substitutes
WASHINGTON – The Occupational Safety and Health Administration recently revised its National Emphasis Program (NEP) on Microwave Popcorn Processing Plants. The purpose of this revised NEP is to minimize or eliminate worker exposure to the hazards associated with microwave popcorn manufacturing.
Diacetyl is a chemical used to add flavor and aroma to food and other products. Some workers who breathe diacetyl on the job have become disabled or have died from severe lung disease. Some manufacturers of microwave popcorn are now using diacetyl substitutes such as 2,3-pentanedione, diacetyl trimer and acetoin among others. Recent studies have shown that 2,3-pentanedione has produced similar health effects as diacetyl, and therefore, may also cause harm to workers.
“It is alarming that workers continue to be at risk of dying from exposure to diacetyl and diacetyl substitutes,” said Assistant Secretary of Labor for Occupational Safety and Health Dr. David Michaels. “Illnesses and death from these chemicals are preventable and this revised directive will help ensure that employers use necessary measures to protect workers from this hazard.”
OSHA’s efforts to minimize or eliminate workers’ exposure to microwave popcorn manufacturing hazards include inspection targeting, directions for controlling chemical hazards, and extensive compliance assistance. Inspections conducted under this NEP will target facilities where workers are manufacturing or processing microwave popcorn.
Currently, OSHA has permissible exposure limits (PEL) for some diacetyl substitutes, however most flavorings do not have PELs. Additionally, microwave popcorn manufacturing facilities are subject to other applicable OSHA mandatory standards including Respiratory Protection and Hazard Communication.
For more safety and health information on diacetyl and other food flavorings, visit OSHA’s Safety and Health Topics page on Lung Disease Related to Butter Flavorings Exposure. OSHA’s Safety and Health Information Bulletin and companion Worker Alert recommend engineering and work practice controls for regulating diacetyl and diacetyl substitute exposures in the workplace.
Under the Occupational Safety and Health Act of 1970, employers are responsible for providing safe and healthful workplaces for their employees. OSHA’s role is to assure these conditions for America’s working men and women by setting and enforcing standards, and providing training, education and assistance.
# # #
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Prometrix Consulting, with a staff of former OSHA officials, offers expert consulting and training services to help clients ensure compliance with complex workplace safety and health requirements. These services include, in part:
Workplace Safety and Health Programs:
Prometrix experts can help you establish a workplace safety and health program that sets the foundation for OSHA compliance and worker protection. We can also review existing programs to ensure ongoing compliance with complex requirements.
Preparations for OSHA National Emphasis Programs (NEPs):
Our staff of former senior OSHA officials will conduct a thorough mock inspection consistent with NEP directives and Agency procedures to identify and address areas of vulnerability.
Action Planning for OSHA Citations:
Our staff will analyze your case, and if applicable, negotiate a settlement or help contest an unfair citation predicated on us also helping you implement corrective safety and health programs for continued compliance.
Contact us via http://prometrixinc.com/contact-us or info@prometrixinc.com regarding your OSHA compliance issues.
Follow us on Twitter: @Prometrix
Some helpful quick links:
OSHA Consulting, OSHA Consultants, OSHA Experts, Prometrix, Prometrix Consulting, OSHA Resources, OSHA Blog, Diacetyl, Diacetyl NEP, OSHA Diacetyl, DAPORS, DIACETYL SHIB, Cal/OSHA Diacetyl Rule, Diacetyl Training.
Below are a number of quotes which were provided as part of an interview regarding the topic of OSHA Reguatory Agenda item: Food Flavorings / Diacetyl. The SHIB which was published by the agency a couple of months ago has a number of serious flaws. In the new OSHA Reg Agenda published on December 20, 2010, the agency announced that it will be expanding the diacetyl rulemaking to include many other food flavorings as well. Below are some quotes which were provided.
By the way, it doesn’t look like OSHA will do another SBREFA panel for this expanded rulemaking item. They most certainly should. The small business community that participated in the previous panel had a certain paradigm of thinking (ie: we can always substitute our ways out of the problem among other thoughts) which no longer applies.
OSHA Expansion of Diacetyl / Food Flavoring Rulemaking:
“When they came out with the SHIB about 6 weeks ago, it was basically signalling that they were going to expand the scope of diacetyl rulemaking. I fully support the rulemaking process, but those rules and guidance materials ought to be based on sound science and data which enables employers to properly and effectively protect their employees against these hazards.”
Regarding the OSHA SHIB on Diacetyl / Food Flavorings:
“This may be the first time OSHA has used the phraseology ‘what employers must do’. That is a highly unusual phrase to be used in the context of a SHIB’s purpose. My question is: which is it?”
“My concern is nobody knows what is causing the problem. Is it diacetyl, is it diacetyl with a combination of other chemicals? We just don’t know. I think it’s important that we don’t just haphazardly presume that all of these chemicals are hazardous when this may not be the case.”
“Furthermore, it’s important to ask what new science or enforcement findings are they using as the basis for this scope expansion?”
“I’m hopeful that the regulators will rely on sound science and data rather than presumptions as inferred in parts of the SHIB.”
“They’re expanding this rulemaking process and they haven’t released any public information on the NEP. That ought to be published so that people can see what they’re finding and start to put the picture together.”- similar to what they did for combustible dust.
“Is OSHA hinting that they are finding significant issues in its latest NEP which is providing the basis for the scope expansion? If so, I would hope that they will publish that information soon so that employers can begin implementing corrective actions without delay.”
***
Prometrix Consulting, with a staff of former OSHA officials, offers expert consulting and training services to help clients ensure compliance with complex workplace safety and health requirements. These services include, in part:
Workplace Safety and Health Programs:
Prometrix experts can help you establish a workplace safety and health program that sets the foundation for OSHA compliance and worker protection. We can also review existing programs to ensure ongoing compliance with complex requirements.
Preparations for OSHA National Emphasis Programs (NEPs):
Our staff of former senior OSHA officials will conduct a thorough mock inspection consistent with NEP directives and Agency procedures to identify and address areas of vulnerability.
Action Planning for OSHA Citations:
Our staff will analyze your case, and if applicable, negotiate a settlement or help contest an unfair citation predicated on us also helping you implement corrective safety and health programs for continued compliance.
Contact us via http://prometrixinc.com/contact-us or info@prometrixinc.com regarding your OSHA compliance issues.
Follow us on Twitter: @Prometrix
Some helpful quick links:
OSHA Consulting, OSHA Consultants, OSHA Experts, Prometrix, Prometrix Consulting, OSHA Resources, OSHA Blog, Diacetyl, Diacetyl NEP, OSHA Diacetyl, DAPORS, DIACETYL SHIB, Cal/OSHA Diacetyl Rule, Diacetyl Training.
I’m not quite sure why the Agency has overlooked this, so I sent them an email to let them know of the oversight regarding the Diacetyl NEP. As we all know, OSHA released its first NEP (Diacetyl in Microwave Popcorn) in 2007 and that program ran its course so to speak. Then in 2009, the Agency issued an expanded NEP (Food Flavorings Containing Diacetyl) and they have stated that they are looking at expading the program yet again to basically include “all” (I use that term loosely) food flavoring chemicals which may pose a hazard. According to the SHIB, this amounts to some 40-50 chemicals, including Furfural, Acethaldehyde, Acetic Acid, Acetoin, and many others.
Lets keep in mind: 1) OSHA published (albeit one with flaws) a new SHIB. Then, 2) Cal-OSHA published a new Diacetyl rule a few short weeks later. And now, 3) OSHA Regulatory Agenda is due to come out literally any day now.
But in the mean time, OSHA’s website makes it easy to find the old / expired NEP on Microwave Popcorn by having it posted on the list of active NEPs. By my count, there are the lucky #13 number of OSHA National Emphasis Programs currently underway. However, the NEP which covers the Food Flavorings Containing Diacetyl are nowhere to be found. I had to spend quite a bit of time searching, Googling, etc in order to find that NEP (it wasn’t all that easy to find, actually). It’s not even posted on its Health Topics Page. So why is the Agency seemingly going out of its way to hide the NEP? I don’t know. Could just be a simple oversight, though something tells me that it could have something to do with the upcoming Reg Agenda. I hope this isn’t some sort of omen for the Agency’s decision to either withdraw the diacetyl rule or delaying its proposal..!!!!
Hey OSHA…. can you please finally post the ALL of the NEPs on your website, please! Much appreciated!
***
Prometrix Consulting, with a staff of former OSHA officials, offers expert consulting and training services to help clients ensure compliance with complex workplace safety and health requirements. These services include, in part:
Workplace Safety and Health Programs:
Prometrix experts can help you establish a workplace safety and health program that sets the foundation for OSHA compliance and worker protection. We can also review existing programs to ensure ongoing compliance with complex requirements.
Preparations for OSHA National Emphasis Programs (NEPs):
Our staff of former senior OSHA officials will conduct a thorough mock inspection consistent with NEP directives and Agency procedures to identify and address areas of vulnerability.
Action Planning for OSHA Citations:
Our staff will analyze your case, and if applicable, negotiate a settlement or help contest an unfair citation predicated on us also helping you implement corrective safety and health programs for continued compliance.
Contact us via http://prometrixinc.com/contact-us or info@prometrixinc.com regarding your OSHA compliance issues.
Follow us on Twitter: @Prometrix
Some helpful quick links:
OSHA Consulting, OSHA Consultants, OSHA Experts, Prometrix, Prometrix Consulting, OSHA Resources, OSHA Blog, Diacetyl, Diacetyl NEP, OSHA Diacetyl, DAPORS, DIACETYL SHIB, Cal/OSHA Diacetyl Rule.
To be honest, I don’t know yet as I have only read the press release at this point. HOWEVER, I can definitely see where this might be going.
Well, looks like Cal/OSHA has published a new rule on Diacetyl which may explain why Fed OSHA recently issued their own SHIB as what seems to be a last minute effort. I don’t know if there is a PEL in there or not. I can only hope that there is one and that it’s not a cop-out level of 0 (zero) ppm. I’ll read the rule later and see if any ‘revelations’ come to mind that should be posted as an update. By the way, I’m not really following the issue too closely from the FDA perspective but I do know that they have (still are?) looking at Diacetyl. That’s where the consumer end of the exposures (or alledged exposures if you want to get legally technical, I suppose) will be addressed. And by the way, it’s not just popcorn where the FDA could theoretically take this… see article (or blog post) about presence of Diacetyl in “fake cigarettes” posing possible health risks for kids.
One thing that is bothering me a litte bit is that there seems to be more of a focus by the agencies (both Cal-OSHA and Fed OSHA) over “who’s the leader” and jabbing each other etc. That’s noted with the quote “At this time, not even Federal OSHA has a safety regulation for diacetyl, but we hope that this standard will serve as a model for them to follow.” in the press release. This brings, to my mind, the famous quote from President Ronald Reagan …. “There is no limit to what you accomplish if you don’t care who gets the credit.” I wish they would focus more on helping to identify and solve the dang problem instead of trying to play ‘one-upsmanship’. What that comment really necessary – or helpful? I don’t. As for it being a model for Fed OSHA to follow, I’ll have to read it first to see. Maybe it is, maybe it isn’t. I guess that would put me as ‘cautiously optimistic’.
I don’t want this next comment to be misconstrued because I really do, on a professional level, appreciate the fact that at least they’re trying to do something about the problem. But come on…!!! To let the Diacetyl SHIB out when you have to know that there are flaws or shortcomings in it (even more than I mentioned in a previous post but didn’t do so because I didn’t want to make it a laundry list…) just to ‘beat the other out of the gate’ is just plain silly-season. I’m genuinely concerned that the SHIB may cause confusion among affected manufacturing companies, particularly since it delves into substitutes and numerous other chemicals and not just Diacetyl. Let’s clearly define the problem so that the industry, safety and health professionals, affected workers, and other stakeholders can develop prudent strategies to mitigate the risks! Not elbow each other for “who’s first” jokeying position. Solve the problem, the rest shall follow.
What will be even more helpful in this whole debate is for OSHA and relevant State Plans to publish a report on what they have found in their two Diacetyl related NEPs (Microwave Popcorn issued 3 years ago and Food Flavorings Containing Diacetyl issued a little more than a year ago). Here’s a ‘shout-out’ to OSHA… the 1-year progress report for the NEP on Combustible Dust was PHENOMENAL. You created your own problem here (that’s a compliment) by producing a fantastic document — and stakeholders wanting more of them. I can only hope that you do continue in releasing such reports. What a great “tradition” to leave as a legacy so to speak for future Administrations to come! Seriously!
More posts on this topic will likely follow in the coming days and weeks. Mean time, in case you are interested in reading the press release, it is posted below for your reference.
*** Reposted Press Release ***
California Becomes First State to Set Safety Guidelines for Flavoring Chemical
OAKLAND, Calif., Dec. 2, 2010 /PRNewswire-USNewswire/ — Cal/OSHA continues to be a national leader in worker safety by implementing a new standard today to protect employees who work with diacetyl, a chemical commonly used to give food flavorings a buttery taste. Cal/OSHA, a division of the California Department of Industrial Relations (DIR), is the only state-OSHA plan to have such a standard.
“The diacetyl standard is the latest example of how Cal/OSHA is on the forefront of worker safety,” said DIR Director John C. Duncan. ”We have taken the lead on this issue from day one and have worked closely with national medical experts as well as the National Institute of Occupational Safety and Health to get to this point. We refuse to wait until more workers suffer serious lung ailments to take action. At this time, not even Federal OSHA has a safety regulation for diacetyl, but we hope that this standard will serve as a model for them to follow.”
The new standard, section 5197 of the California Code of Regulations, requires employers covered by the standard to create a regulated area for each process using diacetyl, unless the process is enclosed. Employers must also provide safeguards for employees who work with diacetyl at certain concentrations. These safety measures include creating a written diacetyl control program, periodic monitoring of exposure levels and providing personal protective equipment, respirators, training, and medical surveillance at no cost to employees. The standard goes into effect today.
“Diacetyl, a chemical that is harmless when it occurs naturally or as an ingredient in many of the foods we eat, can be dangerous in industrial settings where flavorings or foods are manufactured because it is used in much higher concentrations that allow it to get into the air that workers breathe,” said Cal/OSHA Chief Len Welsh. ”Cal/OSHA has issued citations in the past related to exposure to diacetyl, but this comprehensive standard will allow us to better target our enforcement efforts.”
Workers from two California flavoring companies that use diacetyl have been diagnosed with bronchiolitis obliterans — inflammation and scarring of the small airways that can result in permanent and life threatening narrowing of the airways. A number of employees nationwide who have been exposed to diacetyl have developed the serious respiratory illness which in some cases has resulted in patients being placed on lung transplant wait lists or dying. Symptoms include persistent dry cough, shortness of breath when using extra energy, and wheezing.
Cal/OSHA Consultation also works to protect employees from dangerous food-flavoring chemicals. Consultation initiated its Flavor Industry Safety and Health Evaluation Program (FISHEP) in 2006 to provide assistance to California food flavor manufacturing companies. Consultation staff conducted mandatory onsite evaluations and consultations with 28 California companies that use pure flavoring ingredients to manufacture food flavors.
***
Prometrix Consulting, with a staff of former OSHA officials, offers expert consulting and training services to help clients ensure compliance with complex workplace safety and health requirements. These services include, in part:
Workplace Safety and Health Programs:
Prometrix experts can help you establish a workplace safety and health program that sets the foundation for OSHA compliance and worker protection. We can also review existing programs to ensure ongoing compliance with complex requirements.
Preparations for OSHA National Emphasis Programs (NEPs):
Our staff of former senior OSHA officials will conduct a thorough mock inspection consistent with NEP directives and Agency procedures to identify and address areas of vulnerability.
Action Planning for OSHA Citations:
Our staff will analyze your case, and if applicable, negotiate a settlement or help contest an unfair citation predicated on us also helping you implement corrective safety and health programs for continued compliance.
Contact us via http://prometrixinc.com/contact-us or info@prometrixinc.com regarding your OSHA compliance issues.
Follow us on Twitter: @Prometrix
Some helpful quick links:
OSHA Consulting, OSHA Consultants, OSHA Experts, Prometrix, Prometrix Consulting, OSHA Resources, OSHA Blog, Diacetyl, Diacetyl NEP, OSHA Diacetyl, DAPORS, DIACETYL SHIB, Cal/OSHA Diacetyl Rule.
After taking a closer look at the SHIB, a few issues come to mind and are noted below. Hopefully, with the Diacetyl rulemaking effort, all stakeholders will soon be able to provide substantive comments help facilitate meaningful progress. Workers’ protection is at stake… it’s not like that’s important or anything. (yes, that is a bit of scarcasm at the end there).
- There is a distinct change in language in this new SHIB which seems to be going unnoticed by stakeholders in the food manufacturing and flavoring industry. Specifically, there is a new purpose for this SHIB which I have not seen in previous guidance documents. That is, ‘to: Help employers understand the steps they must <emphasis added> take to provide their workers a safe and healthful work environment free of recognized hazards.’ The unusual and confusing use of the term ‘must’ conflicts with the SHIB’s disclaimer whereby it states that this document creates no new legal requirements. As a result, this document may create confusion among employers, industry safety and health professionals, workers, and other stakeholders as to what is required, what is recommended, and what might be cited. By virtue of this SHIB, is OSHA mandating new requirements on employers? This is a serious issue which ought to be addressed, clarified, and/or corrected by OSHA. Historically, the purpose of OSHA SHIBs has been to create awareness among employers and stakeholders of emerging risks, assist employers in identifying and mitigating potential risks, and generally to provide useful information to employers in order to better protect their employees. It appears that this SHIB may be taking that approach into a new direction.
- Diacetyl has been identified as a ‘marker chemical’ suspected of contributing – solely or in combination with other chemicals – to a debilitating and irreversible lung disease commonly referred to as popcorn lung. As a result, the Agency seems to be taking the position that many or all of the viable substitutes for Diacetyl will require the same precautions. If this is the case, then OSHA and NIOSH need to provide clearer and more definitive direction because the industry is moving away from Diacetyl with substitutes which may not be any less problematic. In other words, the industry may be unwittingly jumping out of the pot and into the fire. The SHIB’s purpose uses the word ‘must’. The section in the SHIB which introduces OSHA’s recommendations states that certain practices are recommended for all flavorings including Diacetyl and its substitutes. The SHIB’s disclaimer states that this creates no new legal obligations. Which is it…. a must, strong recommendation, or simply information?
- Is this OSHA’s attempt at backdoor rulemaking? I guess the release of the anticipated Fall Unified Regulatory Agenda may shed some light in that regard.
- The industry has been awaiting definitive direction on the issue of Diacetyl and related substances. This SHIB seems to be confusing the issue, especially as it relates to substitutes. The industry wants to protect its workers. However, instituting expensive engineering controls and product reformulation without knowing whether they have reduced exposures low enough — or unwittingly substituted one problem for another — is unsettling.
***
Prometrix Consulting, with a staff of former OSHA officials, offers expert consulting and training services to help clients ensure compliance with complex workplace safety and health requirements. These services include, in part:
Workplace Safety and Health Programs:
Prometrix experts can help you establish a workplace safety and health program that sets the foundation for OSHA compliance and worker protection. We can also review existing programs to ensure ongoing compliance with complex requirements.
Preparations for OSHA National Emphasis Programs (NEPs):
Our staff of former senior OSHA officials will conduct a thorough mock inspection consistent with NEP directives and Agency procedures to identify and address areas of vulnerability.
Action Planning for OSHA Citations:
Our staff will analyze your case, and if applicable, negotiate a settlement or help contest an unfair citation predicated on us also helping you implement corrective safety and health programs for continued compliance.
Contact us via http://prometrixinc.com/contact-us or info@prometrixinc.com regarding your OSHA compliance issues.
Follow us on Twitter: @Prometrix
Some helpful quick links:
OSHA Consulting, OSHA Consultants, OSHA Experts, Prometrix, Prometrix Consulting, OSHA Resources, OSHA Blog, Diacetyl, Diacetyl NEP, OSHA Diacetyl, DAPORS, DIACETYL SHIB.
This article is reposted from AOLnews.
Discusses, in part, some of the issues associated with e-cigs (“fake cigarettes”) in terms of Diacetyl / Flavorings. Red font below highlights some specific partions on the topic of having diacetyl (or other flavorings) in “fake cigarettes”.
E-Cigs: Popular With Kids, but What’s in Them?
The one-table kiosk offered individual electronic cigarettes for $20 and “complete starter packs” with multiple flavors for $140. The girls, who had ridden Amtrak from Philadelphia, bought an assortment for themselves and some friends.
“They’re very grown-up, you know,” one girl said.
There is a nationwide prohibition on selling tobacco products to anyone under 18, but AOL News was unable to find any federal laws that ban the sale of these nicotine-dispersing faux cigarettes to children, despite growing concerns about the safety of the products by health experts and the public.
Only a handful of states, like New Hampshire, Arizona, Oregon, Minnesota and New Jersey, restrict the sale by age. Others are considering restrictions or outright bans. The devices are being advertised and sold to kids and grown-ups throughout the country, yet little is known about what the estimated million or more people using them are sucking into their lungs.
“The sale of these electronic devices is absolutely a health issue, especially to children,” Marie Cocco, a spokeswoman for the Campaign for Tobacco-Free Kids, told AOL News this week.
Her fear is that these devices have been and are being sold in hundreds of malls across the U.S. Estimates from the e-cigarettes industry say the number of outlets is probably higher than 500 and growing rapidly.
With e-cigs flavors like bubblegum, buttered popcorn, fudge and cookie dough, and the fact that there is apparently no age restriction on their sale to minors, the devices are becoming enormously popular among teens and even those younger, says the Campaign for Tobacco-Free Kids and other health advocacy groups.
Survey: Public Wants Regulation
Almost all of the electronic smoking devices — cigarettes, pipes or cigars — contain a metal tube; a rechargeable, battery-operated heating element; a replaceable cartridge that may contain nicotine or other liquids; and an atomizer that, when heated, converts the contents of the cartridge into a smoke-like vapor.
All are designed to deliver vapors of nicotine, flavoring agents or other substances, including vitamins, herbal remedies, “calming ingredients” and medication guaranteed to cure or help almost any ailment.
That may sound innocent enough, but a new study shows that many people are already worried about these untested products.
According to a survey of 2,061 people released this week by the University of Michigan’s National Poll on Children’s Health [pdf], 91 percent think manufacturers should be required to test e-cigarettes for safety, 85 percent favor prohibiting the sale of e-cigarettes to minors and 82 percent think the FDA should regulate e-cigarettes like other nicotine-containing products.
“There is not yet much scientific evidence about e-cigarettes and kids yet, because these new devices have not been tested extensively,” Dr. Matthew Davis, director of the University of Michigan C.S. Mott Children’s Hospital National Poll on Children’s Health, told AOL News. “But our poll results strongly indicate that many adults are worried about e-cigarettes leading kids to smoke tobacco. Most adults feel that e-cigarettes should be regulated by the FDA like other nicotine-containing products.”
Do No Harm?
Toxicologists, risk assessors and cancer specialists from the National Institutes of Health, the Centers for Disease Control and Prevention and the FDA have long worried about the hazards that could be caused by using these devices. So why has it taken so long for the FDA to get involved?
The agency says it hasn’t tested the toxicity of the liquids or “e-juice” used in the devices or received any useful information from the distributors. Nevertheless, the FDA acknowledges there are signs of health problems.
“It’s criminal to allow diacetyl and other untested flavoring agents to be used in these devices,” said Dr. David Egilman, clinical associate professor at Brown University’s Department of Family Medicine. “At the very least, it’s not smart to intentionally inhale substances which have been proven to cause irreversible lung disease that has and can kill you.”
For about 10 years, Egilman has served as an expert witness in scores of cases of people allegedly harmed by diacetyl.
“Americans need to understand that contrary to political rhetoric, there is no real federal regulation of food or food additives,” he said. “There is overwhelming evidence that smoke from cigarettes which contains diacetyl causes disease in the terminal bronchioles — the furthest and smallest tubes that carry air to the lungs.”
Canadians Ban E-cigs; Why Not U.S.?
Health Canada had no more information than the FDA does on these products, but last year the Canadian agency ordered that “persons importing, advertising or selling electronic cigarette products in Canada must stop doing so immediately” because they “may pose health risks and have not been fully evaluated for safety, quality and efficacy” by the agency.
“The prohibition on these electronic cigarettes still stands,” Health Canada spokesman Gary Scott Holub told AOL News this week.
If the Canadians could do it, why not U.S. regulators?
The answer from the FDA’s spokeswoman was lacking in specifics and offered no clue as to why the agency didn’t take a firmer stand.
“The agency has not made a decision to remove all e-cigarettes from the market,” but “will regulate electronic cigarettes and related products in a manner consistent with its mission of protecting the public health,” DeLancey said.
What little analysis FDA has conducted shows potentially serious problems.
Agency scientists examined 19 different e-cig brands from two major distributors and found disturbing results, including:
- Significant quality problems that indicate that quality-control processes used to manufacture these products are substandard or nonexistent.
- Cartridges labeled as containing no nicotine contained low levels of nicotine in all tested but one; three different electronic cigarette cartridges with the same label emitted a markedly different amount of nicotine with each puff.
- Certain tobacco-specific nitrosamines, which are human carcinogens, were detected in half of the samples tested.
- Tobacco-specific impurities suspected of being harmful to humans — anabasine, myosmine and β-nicotyrine — were detected in a majority of the samples tested.
As a result of these findings, the FDA greatly angered the industry when it thwarted the importation of more than 800 shipments of electronic cigarettes into the U.S. on the grounds that they were unapproved drug devices. At least two importers roared that the FDA had no right to meddle with their products and quickly filed suit in federal court.
Perhaps the lingering lawsuits by two e-cig importers and intense lobbying on Capitol Hill thwarted earlier efforts by U.S. agencies to regulate the products, let alone halt their sale. But last week’s FDA action against five large distributors offered some hope that the unfettered marketing of these products may be slowed a bit.
A Secretive Industry
It’s difficult for potential regulators, health investigators and even consumers to get direct answers to questions about the industry.
But in May, a man who offered only a first name, which changed from Fedir to Teddy and back, said he was responding to AOL News’ request from information from the Electronic Cigarette Association.
Here’s what came from scattered discussions with him:
- More than 1.25 million people are using the cigarette products, and between 2,000 and 18,000 new users begin sucking on the metal and plastic devices each month.
- Between 300 and 500 companies are selling the products in the U.S., some running 30 or more separate outlets, but, Fedir added, “only a handful of people own them all.”
- The devices were manufactured in five Chinese factories, three owned by the same people, but are sometimes transshipped through European ports.
Photographs of attractive young people and beautiful women gazing into the distance are used by most of the online sales sites to convey the message that e-cigs are cool, Fedir explained.
By far, he said, the greatest sales come from websites and online stores. Importers sell the same e-cigs under various names.
When asked about health studies, Fedir said he would get the information. He never did.
AOL News attempted repeatedly to contact Matt Salmon, who, according to the FDA, is the current president of the industry association to verify and update the information offered four months ago by Fedir. Salmon did not respond to several e-mails, and the phone numbers on the association’s website were for a public relations agency that said it was no longer handling “that account.”
Concerns Remain, but Who’s Paying Attention?
Some of the e-cig websites insist they have corrected problems in their products that FDA scientists reported last year.
“FDA is still concerned about electronic cigarettes because there is little scientific information on their safety, efficacy or quality,” DeLancey said.
But the two eighth-grade girls from Philadelphia were oblivious to all that jargon when they made their purchases that day at Union Station in Washington. Why did they travel more than 130 miles each way to buy e-cigarettes?
“They’re a lot cheaper here,” one of the girls said before they both rushed off to get the train home.
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Prometrix Consulting, with a staff of former OSHA officials, offers expert consulting and training services to help clients ensure compliance with complex workplace safety and health requirements. These services include, in part:
Workplace Safety and Health Programs:
Prometrix experts can help you establish a workplace safety and health program that sets the foundation for OSHA compliance and worker protection. We can also review existing programs to ensure ongoing compliance with complex requirements.
Preparations for OSHA National Emphasis Programs (NEPs):
Our staff of former senior OSHA officials will conduct a thorough mock inspection consistent with NEP directives and Agency procedures to identify and address areas of vulnerability.
Action Planning for OSHA Citations:
Our staff will analyze your case, and if applicable, negotiate a settlement or help contest an unfair citation predicated on us also helping you implement corrective safety and health programs for continued compliance.
Contact us via http://prometrixinc.com/contact-us/ or info@prometrixinc.com regarding your OSHA compliance issues.
It was reported in the Joplin Globe today that a jury in the Chicago area has awarded a $30 million verdict to a worker who was exposed to Diacetyl and developed Bronchiolitis Obliterans (also known as Popcorn Lung). This is an irreversible lung disease which can lead to an organ transplant in extreme cases. Prometrix Consulting, with a staff of former OSHA officials, is offering expert consulting and training services to help employers comply with complex workplace safety and health requirements.
Prometrix has developed a unique expertise in managing Diacetyl / Popcorn Lung risk for food flavoring companies. To learn more about the topic, please read our blog posts on the topic here on prometrixinc.com. It’s important that employers facing this issue get up to speed on how to minimize their risk and protect their workers. OSHA is currently conducting a National Emphasis Program that is targeting Food Flavoring Containing Diacetyl as well as working on new standard to address the issue.
Illinois worker wins $30 million verdict in diacetyl popcorn chemical lawsuit
Source: Joplin Globe
CHICAGO — A jury in Chicago has awarded a $30.4 million verdict to a chemical-flavoring plant worker disabled by exposure to diacetyl, an ingredient in butter flavoring used at a Jasper popcorn plant where several workers claimed similar injury.
The verdict awarded to Gerardo Solis, 45, and against BASF Corp., a supplier of diacetyl and the world’s largest chemical company, is the highest rendered to date in popcorn and butter-flavoring worker lawsuits in the U.S., according to Ken McClain, the attorney for Solis.
Solis worked at a Flavorchem Corp. plant in the Chicago area between the years 1998 and 2006 when he was diagnosed with a rare lung disease called bronchiolitis obliterans. McClain said Solis is totally disabled with 25 percent of normal lung capacity and is projected to require a lung transplant within the next 10 years.
The largest verdict previously awarded to an individual in the cases was $20 million granted by a Jasper County jury to Eric Peoples of Carthage and his wife in 2004. Two $15 million verdicts and a $2.7 million award were rendered to other workers at the former Jasper Popcorn Co. plant. Those cases involved Bush Boake Allen Inc. and International Flavors & Fragrances Inc., suppliers of butter flavoring to the plant and not BASF.
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Prometrix Consulting, with a staff of former OSHA officials, offers expert consulting and training services to help clients ensure compliance with complex workplace safety and health requirements. These services include, in part:
Workplace Safety and Health Programs:
Prometrix experts can help you establish a workplace safety and health program that sets the foundation for OSHA compliance and worker protection. We can also review existing programs to ensure ongoing compliance with complex requirements.
Preparations for OSHA National Emphasis Programs (NEPs):
Our staff of former senior OSHA officials will conduct a thorough mock inspection consistent with NEP directives and Agency procedures to identify and address areas of vulnerability.
Action Planning for OSHA Citations:
Our staff will analyze your case, and if applicable, negotiate a settlement or help contest an unfair citation predicated on us also helping you implement corrective safety and health programs for continued compliance.
Contact us via http://prometrixinc.com/contact-us or info@prometrixinc.com regarding your OSHA compliance issues.
Follow us on Twitter: @Prometrix
Food flavoring manufacturers and users that have Diacetyl / DAPORS on their premises will benefit from understanding the role of safe work practices and administrative controls. These round out the other protective methodologies to help ensure compliance against OSHA’s NEP on Food Flavorings and overall enhanced workplace safety and health performance.
Safe Work Practice Controls:
Think of these controls as fine tuning once engineering and respiratory protection and personal protective controls have been implemented. These controls arise after a careful study of work processes. They include the most efficient integration of engineering and respiratory protection controls to maximize efficiency and reduce employee fatigue. A large part of such controls is simply good supervision that maximizes and integrates the effectiveness of higher order controls.
Examples may include:
- the elimination of drinking, smoking, chewing gum etc from work areas
- maintaining an organized and clean work environment
- providing specific training on body and hand positions when handling DAPORS
Administrative Controls:
Administrative controls include controlling employees’ exposure by scheduling production and tasks, or both, in ways that minimize exposure levels. For example, scheduling operations with the highest exposure potential during periods when the fewest employees are present or by reducing inventory of hazardous materials to the lowest amount necessary.
****
Prometrix Consulting, with a staff of former OSHA officials, offers expert consulting and training services to help clients ensure compliance with complex workplace safety and health requirements. These services include, in part:
Workplace Safety and Health Programs:
Prometrix experts can help you establish a workplace safety and health program that sets the foundation for OSHA compliance and worker protection. We can also review existing programs to ensure ongoing compliance with complex requirements.
Preparations for OSHA National Emphasis Programs (NEPs):
Our staff of former senior OSHA officials will conduct a thorough mock inspection consistent with NEP directives and Agency procedures to identify and address areas of vulnerability.
Action Planning for OSHA Citations:
Our staff will analyze your case, and if applicable, negotiate a settlement or help contest an unfair citation predicated on us also helping you implement corrective safety and health programs for continued compliance.
Contact us via http://prometrixinc.com/contact-us or info@prometrixinc.com regarding your OSHA compliance issues.
Although this post is in context of Diacetyl / DAPORS / Popcorn Lung, it is important to remember that an appropriate medical surveillance program plays an important part in ensuring employee protections in other circumstances as well. The specifics of the medical surveillance program will depend on the particular issues encountered at a given facility. In the case of food flavoring manufacturers, for example, monitoring employees for certain health conditions such as what will seem like occupational asthma, but may actually be the development of a rare lung disease called bronchiolitis obliterans (more commonly known as ‘popcorn lung’).
Employers implementing such a program need to remember that this is sort of a last line of defense in terms of protecting employees from health hazards. Implementing engineering controls to design the hazard out of the work process, proper personal protective equipment, effective training are some of the other risk mitigation methods that can help prevent the possibility of illnesses from developing in the first place. More on those methodologies are/will be available in other posts.
OSHA has launched a National Emphasis Program (NEP) on Food Flavorings Containing Diacetyl. One of the things the Compliance Officer will be looking for is a sound medical surveillance program.
According to the OSHA NEP Directive on Food Flavorings Containing Diacetyl, Medical Surveillance Program(s) might want to consider:
A medical screening program can help employers identify employees experiencing adverse health effects from exposure to hazardous food flavoring chemicals. Spirometry, or pulmonary function testing (PFT), measures the breathing capacity of the lungs and is the best available test for early detection of decreasing or abnormal lung function amongexposed employees.For starters, it is recommended that employers:
- Perform a baseline spirometry test for all newly-hired employees and ask each
employee to complete a health questionnaire before starting work in areas where
there is exposure.
- Perform a medical evaluation (i.e. health questionnaire) and spirometry every six
months for all employees exposed. A qualified physician with expertise in
occupational lung disease can make additional recommendations regarding the
nature and frequency of medical examinations and spirometry based on employee
exposures specific to operations in your facility.
****
Prometrix Consulting, with a staff of former OSHA officials, offers expert consulting and training services to help clients ensure compliance with complex workplace safety and health requirements. These services include, in part:
Workplace Safety and Health Programs:
Prometrix experts can help you establish a workplace safety and health program that sets the foundation for OSHA compliance and worker protection. We can also review existing programs to ensure ongoing compliance with complex requirements.
Preparations for OSHA National Emphasis Programs (NEPs):
Our staff of former senior OSHA officials will conduct a thorough mock inspection consistent with NEP directives and Agency procedures to identify and address areas of vulnerability.
Action Planning for OSHA Citations:
Our staff will analyze your case, and if applicable, negotiate a settlement or help contest an unfair citation predicated on us also helping you implement corrective safety and health programs for continued compliance.
Contact us via http://prometrixinc.com/contact-us or info@prometrixinc.com regarding your OSHA compliance issues.