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After months of research, the Government Accountability Office told Congress it was concerned about a well-known loophole in the Food and Drug Administration regulations that for decades has concerned consumer and public health advocates.

It deals with a often controversial exception to the FDA’s practice of demanding rigorous analysis of the contents of processed food. Immunity from the FDA’s scrutiny is bestowed with the four word designation of “generally regarded as safe.”

What this means is that food manufacturers who want to include an additive in a food product are often spared having to spend hundreds of thousands of dollars in safety tests and can save years in getting something on to store shelves.

The GAO determined that:

• FDA generally doesn’t know about most of these GRAS determinations because companies are not required to inform the agency.
• FDA has not taken steps that could help ensure the safety of additives listed as GRAS.
• Food products may contain numerous ingredients, including GRAS substances, making it difficult, if not impossible, for public health authorities to attribute a food safety problem to a specific GRAS additives.
• FDA does not systematically reconsider the safety of GRAS substances as new information or new methods for evaluating safety become available.

The investigators also noted that while FDA has issued guidance to minimize the potential for conflicts of interest among its own staff who look at the safety of GRAS substances, it has not issued any restrictions for companies to use with their hired scientific experts.

“There is a relatively small community of experts qualified to sit on the GRAS designation panels and, inevitably, these experts may have corporate or financial affiliations that could bias their decisions,” the report said.

The investigators said it was almost impossible to link adverse effects to GRAS additives because their presence in food is rarely known outside those who produced it.

GAO said that the food safety agency told it that complaints and public concerns could prompt them to reconsider the safety of a GRAS substance.

Yet the FDA’s actions present a different picture.

More than 40 years ago, the GRAS-labeled artificial sweetener cyclamate was banned after allegations of serious health effects. That was pretty much it for decades.

A more serious debate over another GRAS additive is going on today and is generating repeated demands from unions, public health experts and others for another ban.

The substance is diacetyl, a chemical butter flavoring that has killed a handful of workers and sickened hundreds of others in microwave popcorn plants, bakeries, candy makers and other food processors.

What angers worker and food safety specialists even more is that many manufacturers say they have switched to a substitute for the old lung-destroying flavoring additive that government researchers have determined contains just as much or more diacetyl than the old concoction.

It too is listed as GRAS and the FDA knows it, but has done nothing.

Over the past 50 years, thousands of spices, artificial flavors, and binders, vitamins and minerals, and preservatives have been declared as GRAS. These substances are added to enhance a food’s taste, texture, nutritional content, or shelf life.

These safety designations started in 1958, when Congress blessed GRAS by amending the Federal Food, Drug, and Cosmetic Act to say that the safety of an additive “does not need to be established with absolute certainty.”  Rather, the Act said that a scientific panel selected by the manufacturer can rule that no harm will result from the intended use of an additive.

But in reality, the only ones who know whether not the additives are actually safe is the company and its own analysts or the outside labs they hire.

Thousands of exemptions are granted by food industry trade groups. For example, the largest, the Flavor and Extract Manufacturers Association, has bestowed GRAS on more than 2,600 additives since 1960.

The GAO expressed added concern over two specific areas – imported additives, where the level of safety consideration is often completely unknown and the growing use of GRAS designation in engineered nanomaterial in food.

In responding to the report, the FDA says it agreed with many of the faults that GAO documented but said that the agency would have to seek authority from Congress in order to require all companies to inform it of their designation of additives as GRAS.

If that were to happen, FDA said, it could place an added burden on food producers and tax FDA’s resources.

The GAO investigation was requested by two democrats, Iowa Sen. Tom Harkin of and Connecticut Rep. Rosa DeLauro.

Here is  a link to an AOLnews version of this story.

It’s not like it’s a secret that factory workers exposed to vapors from chemical butter substitute have contracted the sometimes deadly and rare disorder called popcorn lung.

More than nine years ago, the illness was traced to workers in microwave popcorn plants throughout the Midwest where, eventually, hundreds were diagnosed with the irreversible disease.

Francisco Herrera lost 70 percent of lung use from diacetyl exposure. Photo by A. Schneider

But it wasn’t just popcorn workers.

In 2006, while working at the Baltimore Sun, I wrote about several employees of California flavoring plants that worked with the diacetyl-based concoction and were sickened by the disease. One, Francisco Herrera, a young father, lost 70 percent of his lung capacity and could no longer lift his children.

In other stories that year, I reported on flavoring workers from coast-to-coast diagnosed with the disease, which is called bronchiolitis obliterans, and causes the destruction of the small airways in the lung.

Occupational medicine experts at the National Institute of Occupational Safety and Health and California’s health and worker safety agencies responded almost immediately to determine how widespread the diacetyl problem was.  However, in California, their efforts were blocked by the flavoring industry and their powerful lobbyists who claimed all was fine.

It wasn’t.

Finally, this week, California regulators have unveiled a first-in-the-nation proposal to control exposures to the potentially deadly flavorings chemical diacetyl.

The standard, which will be discussed at one last public meeting next month, would apply to all flavor and food manufacturing facilities that use diacetyl and flavorings that contain 1 percent or greater concentration of the chemical.

Companies using diacetly will be required to do at least the following:

• Assess the concentration of airborne diacetyl each employee is exposed to while working.
• Use engineering and work practice controls to reduce diacetyl and ensure that employees wear protective face masks when needed.
• Perform medical surveillance of workers, including health questionnaires and pulmonary function tests.
• Report any “flavor-related” diagnosis of fixed obstructive lung disease within 24 hours of becoming aware of it.

While California authorities are concerned primarily with 30 diacetly using companies their state, NIOSH is responsible about workers in the thousands of other companies nationwide that are presumed to use diacetyl or its substitutes. I say presumed because the manufacturers and wholesalers of the chemical have repeatedly refused to identify their customers to the public health investigators

Many in the flavoring industry still argue that diacetyl has not been proven the cause of the rare and life-threatening disease. However, Dr. Kay Kreiss and her colleagues at NIOSH – who have been tracking worker exposure to diacetyl for almost a decade – have shown repeatedly that workers exposed to the highest cumulative diacetyl doses had the greatest risk of having breathing abnormalities.

The NIOSH team continues to pursuit the risk from exposure to diacetyl and the untested chemical butter substitutes that the food industry insists are safe.  But several major industrial users are being far from helpful.

Those concerned about diacetyl exposure are waiting to see what happens at the federal worker safety level.

The newly named head of OSHA – David Michaels ­– and the acting agency head – Jordon Barab – both have years of stridently demanding federal action to protect workers and consumers from this butter flavoring.

I guess we’ll wait to see what they do now that they have the power to make a difference.

Here is a link to the proposed diacetyl standard.

Diacetyl-linked jury verdicts of tens of millions of dollars for injured flavoring workers and the diagnoses of lung damage in at least three popcorn-loving consumers forced popcorn packers and other food processors to stop using the chemical butter-flavoring two years ago.

Orville Redenbacher rose from the grave to proudly announce in a TV ad that the company’s popcorn was now diacetyl-free. And other manufacturers plastered that message in large type on the side of their packages.

When asked in the last two years how they were getting the buttery flavor consumers want without diacetyl, the largest popcorn makers answered with a “no comment,” saying the secret flavoring was safe, but proprietary.

Fortunately, a group of government health investigators at the National Institute of Occupational Safety and Health have begun lifting the veil of corporate secrecy.

“Two possible substitutes are starter distillate and diacetyl trimmer,” NIOSH Drs. Kathleen Kreiss and Nancy Sahakian just wrote in a newly released book, “Advances in Food and Nutrition Research.

“The distillate is a diacetyl-containing product of a fermentation process. The trimmer is a molecule containing three diacetyl molecules,” they wrote. “The inclusion of these alternative substances neither eliminate diacetyl nor assure safety for workers.’’

Kreiss, chief of NIOSH’s Field Studies Branch, also talked about the popcorn advertisements in informal remarks prepared for the American Thoracic Society conference earlier this month in San Diego.

“The wording here (no added diacetyl) is telling,” said Kreiss, whose team of worker health and safety investigators were the first to respond to the reports of disease at Midwest popcorn plants.

In the presentation to the specialists in respiratory disease, Kreiss discussed the flavoring to which many food producers had switched.

“The easiest substitute for the chemical diacetyl is starter distillate, a fermentation product of milk which contains up to 4 percent diacetyl. The chemical may not be added, but diacetyl is still in butter-flavored popcorn,” she explained.

She said some of the substitutes are better able to penetrate to the deepest parts of the lung and are unlikely to be safer to inhale than the original diacetyl.

Physicians, scientists and industrial hygienists at NIOSH’s Division of Respiratory Disease Studies are working hard on multiple efforts to investigate the possible toxicity of butter flavoring chemicals being used as a substitute for the diacetyl.

“We’re trying to identify the mechanism of diacetyl-induced injury. And if that happens, it will help us identify other potentially hazardous compounds workers may be exposed to in the flavoring industry,” said Dr. Ann Hubbs, a veterinary pathologist in NIOSH’s Health Effects Laboratory Division.

Hubbs told me last week, “We are trying hard to answer the question of why diacetyl — and potentially the related substances — are so very toxic,”

Kreiss and her team have responded to plants using flavorings throughout the country. They have watched patiently as OSHA first ignored and then moved haltingly to comply with congressional orders and union pleas to develop diacetyl exposure standards that would protect workers.

But even though President Obama’s new team at the Labor Department promised speedy action on diacetyl standards, many public health and occupational medicine experts worry that it may be too little, coming too late.

“As regulatory action develops, the flavor industry has introduced diacetyl substitutes, which might not be regulated by a diacetyl standard now on the drawing board,” Kreiss said in notes accompanying her slide presentation to the chest doctors.

Dr. Celeste Monforton and her colleagues at George Washington University’s Department of Environmental and Occupational Health have been following the diacetyl issue for years.

She echoes NIOSH and says that OSHA and the Food and Drug Administration must pay attention to the substitutes in its rulemaking if workers and consumers are to be protected.

“We know far too little about the the substitutes to diacetyl or reformulated diacetyl-compounds that food manufacturers are now using, or planning to use,” she told me this week.

As a part of its rule making, OSHA must insist that the manufacturers provide information on the chemical composition and toxicity testing of their substitutes, she said.

“We are dealing with the safety of workers and consumers and secrecy cannot be justified,” Monforton said.

“This potential danger goes well beyond just popcorn.”

This example centers on a year-long court battle between an Indianapolis flavor manufacturer and the government’s top occupational safety investigators. The fact that the company has gone to federal court to keep the federal health and safety wizards from protecting the workers from a sometimes lethal chemical strikes many as well beyond absurd.

At the heart of the dispute is the health of 200 workers at Sensient Flavors International and a chemical mixture that they use called diacetyl, which has killed several and sickened hundreds of workers in plants across the country that use the synthetic butter flavoring. That would include thousands of candies, cookies, baked goods, prepared food products and cooking oils and sprays.

On the other side of the courtroom are the feds – physicians, toxicologists and industrial hygienists – who work for the National Institute for Occupational Safety and Health. Their battle to control exposure to his chemical concoction soared into prominence in August —-2000 when the NIOSH team was called to investigate an outbreak of bronchiolitis obliterans in former workers of Missouri microwave-popcorn plant.

Within months, they found the same irreversible lung disease in other workers at popcorn plants in the Midwest.

The fight with Sensient began almost a year ago when the local Teamsters union representing the plant’s workers asked NIOSH, the worker-safety research arm of the Centers for Disease Control and Prevention, to inspect the plant, which it did.

But when I interviewed Teamster health and safety officials last year they said the company had altered the production process while the feds were inspecting and taking air samples and that the investigators failed to get an accurate idea of the conditions.

NIOSH told Sensient that it wanted to return and take more samples and interview additional workers because “pulmonary abnormalities” uncovered during its first inspection demanded a “second and more extensive examination,” an agency official told me.

The- Indianapolis Business Journal said that Sensient acknowledges federal law gave NIOSH authority to conduct the first inspection. But it says no new information had emerged that would give the feds the right to go through the “highly invasive process” again.

“NIOSH is attempting to use Sensient’s facility as its own personal laboratory,” the company complained in a federal lawsuit filed in July. The company demanded in the lawsuit that the second inspection be blocked.

Dr. David Egilman, a occupational medicine specialist and Clinical Associated Professor at Brown University, who has been examining patients harmed by diacetyl since the first popcorn cases, calls Sensient’s position absurd and dangerous.

“If any one is experimenting, it is Sensient and the guinea pigs are their workers. It is just outrageous that this company that has never tested the toxicity of any of the chemicals it puts in our food has gall to block government researchers efforts to determine if they stuff they are adding to food will kill or injure us,” said Egilman, who has testified on behalf of the injured workers in many of the lawsuits they brought against flavoring companies.

The legal game playing continues in federal court with both sides battling whether discovery requests are too broad or too narrow and other courtroom tactics.
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Meanwhile, the workers continue to mix the diacetyl into flavorings that are being shipped to scores of food-processing plants where other workers will be exposed to the faux butter flavoring.

In related news, after Senate and House hearings, union demands and insistent bellowing of safety activists, OSHA has taken the first step in actually doing something to prevent workers from having diacetyl destroy their lungs.

The agency has asked for public comments on issues related to occupational exposure to diacetyl and food flavorings containing diacetyl. Someone has already submitted the P-I story from 2007 of diacetyl exposure to professional and home cooks from butters, sprays and oils containing the food flavoring. This is a link to the PI’s story on diacetyl.

There is no indication that the Food and Drug Administration, which approved the use of diacetyl years ago without any agency testing, will order any testing of the food flavoring.

No so fast, cautions the Center for Science in the Public Interest. The nonprofit food safety advocate says a new 26-page report by toxicologists at UCLA states that several laboratory tests show that the sweetener “causes mutations and DNA damage, which raises the prospect that it causes cancer.”

The organization wrote the Food and Drug Administration saying that additional testing is needed.

“A safe, natural, high-potency sweetener would be a welcome addition to the food supply,” said CSPI executive director Michael F. Jacobson. “But the FDA needs to be as sure as possible that rebiana is safe before allowing it into foods that would be consumed by tens of millions of people. It would be tragic if the sweetener turned out to cause cancer or other problems.”

Two companies — Cargill and Merisant — have told the FDA that rebiana should designated as “Generally Regarded as Safe,” or GRAS, which is a classification given less scrutiny by the FDA than ordinary food additives. The Center says a third company, Wisdom Natural Brands, has already declared that its stevia-based sweetener is GRAS and will market it without giving evidence to, or even notifying, the FDA.

Yes, you read it correctly. Corporations can hire anyone or even task their janitorial staff to evaluate the safety of a food additive. There are thousands of products out there that have never been tested by anyone beyond “experts” paid by the company selling the product.

Want an example? How about diacetyl, the butter flavoring that has sickened hundreds of popcorn and flavoring plant workers, and caused the deaths of several.

Diacetyl remains on FDA’s list of products considered Generally Regarded as Safe and concerned scientists and physicians who have tried to get our vacationing lawmakers to demand that FDA and OSHA do something about it, are often turned away by legislative staffers who can’t believe that companies alone can be making these vital public health decisions.

I have a hard believing it myself, but it’s true.

As with so many harmful products, such as asbestos or benzine or hundreds of others, we are left with a vacuum created by legislators refusing to do battle for public health and the void is filled by trial lawyers holding the offending corporations accountable with settlements in hundreds of millions of dollars.

Seems like an odd way to protect the public health. But maybe that’s just me.