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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.

We went though this last year with contaminated peanuts from the Georgia and Texas plants of Peanut Corporation of America.

PCA recalled the tainted goobers, but the ripple effect spread for weeks as hundreds of manufacturers pulled thousands of products made with the pathogen-containing nuts off store shelves throughout North American.

It’s not peanuts this time, but rather a flavoring agent called hydrolyzed vegetable protein. As unappetizing as the name sounds, it is used as a flavoring agent in thousands of gravies, sauces, soups, salad dressings and snacks.

The source of the tainted concoction is Basic Food Flavors, Inc., an international supplier of flavor and seasoning agents.   The FDA conducted an investigation of the company’s Las Vegas, Nev., production plant after a customer who purchased the flavoring had it analyzed and found it contained Salmonella.

As the FDA did with the peanuts and does with many other recalled foods, the agency has to wait until the downstream producers of these consumer products realize that the food they’re selling may also be contaminated.

The federal food detectives say they don’t have enough investigators or a structure that permits them to identify and chase all the ingredients in the processed food that’s manufactured and sold in this country.

For more details on this recall see the story I wrote on AOLnews.com.

In fact, it appears it never went away, despite promises from the food industry.

So what is the Obama Administration going to do about it? Nothing meaningful, at least for another year, it said this week, stunning unions, members of Congress, public health activists and physicians who have pleaded for government action to protect workers and consumers from the butter flavoring.

Two years ago this month, the nation’s leading popcorn purveyors proclaimed that they’d done away with the chemical culprit diacetyl, believed to be the harmful element in the food flavoring.

But now, government health investigators are reporting that the “new, safer, butter substitutes” are, in some cases, at least as toxic as what they replaced.

Even the top lawyer for the flavoring industry said his organization has told anyone that would listen that diacetyl substitutes are actually just another form of diacetyl.

“We’ve been very clear to flavor manufacturers, food companies and regulators that these so-called substitutes are diacetyl,” said John Hallagan, General Counsel for the Flavors and Extracts Manufacturers Association.

Hallagan told me this week that his trade association discouraged food manufacturers from using these materials and calling their products “diacetyl-free.” But he quickly admitted that his group has no legal authority to prohibit their use.

That’s up to the food manufacturers.”

But those companies refused to discuss the source of the butter flavoring in their products. But their food scientists and flavorists openly debate it at professional meetings as they sought their peer’s opinions on the value of starter distillates and trimers they were using to achieve the rich butter flavors that consumers love so much.

But federal health investigators, many of whom had chased the dangerous additive for years, had concluded that these butter surrogates may be unsafe.

“The inclusion of these alternative substances neither eliminate diacetyl nor assure safety for workers,’’

physicians from the National Institute of Occupational Safety and Health – Drs. Kathleen Kreiss and Nancy Sahakian – wrote earlier this year. Their agency has led the way in chasing which flavoring agents were sickening factory workers.

On the same trail was Dr. Daniel Morgan, with the Respiratory Toxicity Group at the National Institute of Environmental Health Sciences.   On Monday he told me he had found the same danger in one of the principle components of the butter substitute – a concoction called 2,3-pentanedione.

“It caused the same injuries in test animals as diacetyl and our preliminary data indicates the toxicity is close to identical,” Morgan said.

“We don’t really know what industry is using as a substitute in these ‘diacetyl-free’ items. But, if 2,3-pentanedione was being used, it’s being done without toxicity data.”

The disease from exposure to diacetyl – bronchiolitis obliterans – is debilitating and potentially fatal. It irreversibly destroys the small airways in the lung. The only hope for many is a hard-to-get single or double lung transplant.

It was almost ten years ago, the holiday season, that Dr. Allen Parmet, a really sharp occupational medicine doc, used his experience treating victims of a rocket fuel accident to figured out that workers at a Missouri microwave popcorn plant were having their lungs destroyed by some chemical used at the facility.

A team from NIOSH quickly pointed to diacetyl as the likely villain.

Over the years, unions, congress, scores of physicians and scientists and occupational health experts called on OSHA to take action.

In June 2006, Rep. Hilda Solis, a Democrat who represented the Los Angeles district where two stricken flavoring plant workers lived, reacted to media reports on their illness and demanded that that OSHA do more to protect workers.

“”These illnesses and deaths are preventable,” Solis said at the time. “Further inaction is inexcusable.”

Public health advocates told themselves that when Democrats took over the health and safety agencies the Bush regulations-are-bad-era would vaporize. One measurement  was going to be how quickly the Obama team addressed something diacetyl.

Well, this week the new Labor Secretary, who now happens to be Hilda Solis, addressed it.

She released her plans for worker health and safety, mentioning several specific hazards, including diacetyl.

But instead of expediting carefully crafted rules for diacetyl and worker safety, she ordered another year of bureaucratic review of diacetyl’s health effects.

You’ve got to wonder what really happened to Solis’ great concern for workers exposed to diacetyl.

For a longer version of this story, check out what I wrote on AOL News – Sphere.com.

The scientists – from USDA’s Agricultural Research Service in Tuscon and New Orleans and at the University of Wisconsin – were searching for a possible cause of Colony Collapse Disorder, a mysterious disease that has killed at least one-third of the nation’s commercial bees.

(c) photo by A. Schneider

The team targeted the popular sweetener because it is widely used both with honey bees and those used primarily for vital crop pollination.

High-fructose corn syrup is produced by grinding corn to produce corn starch, then that powder is processed to yield corn syrup, which is almost entirely glucose. Enzymes or proteins are then added which changes the glucose into fructose.

It is the fructose that food producers use to sweeten their products and by commercial beekeepers to strengthen their bees, to increase honey production and as a food supplement when natural sources of nectar and pollen have diminished.

During repeated tests, the researchers found that when the HFCS is heated it forms hydroxymethylfurfural or HMF which can kill honeybees. Alarmingly, they found when temperatures rose, levels of HMF increased steadily in proportion.

The study, by Blaise LeBlanc, Gillian Eggleston and their colleagues, is published this week in ACS’ Journal of Agricultural and Food Chemistry. The authors said their work could also help keep the substance out of soft drinks and dozens of other human foods that contain HFCS.

“The data are important for commercial beekeepers . . . and because HFCS is incorporated as a sweetener in many processed foods, the data from this study are important for human health as well,” states the report which was funded by the National Honey Board.

Laboratory studies in Sweden published this year have linked HMF to DNA damage in humans, the USDA team reported.  In addition, HMF breaks down in the body to other substances – daughter metabolites ­– potentially more harmful than the original substance.

For close to a decade, researchers throughout the world have been searching for the cause of the widespread destruction of bee colonies.

In the U.S., the growing shortage of honey has caused the increased importation of foreign products, much of which is wrongly labeled to avoid paying tariffs on Chinese honey. Some are adulterated with illegal antibiotics on violation of FDA regulations.

Here is a link to the study published by the ACS.

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.

Howard served at the top gun in CDC’s crucial worker health research agency from 2002 through 2008 and also held the sometimes uncomfortable position of Coordinator of HHS’ World Trade Center Health Programs.

Dr. Howard brings impressive credential with him. He is board-certified in internal medicine, legal medicine and occupational medicine.

In the past, the doctor/lawyer allowed his talented team to pursue investigations into controversial workplace health hazards such as the diacetyl butter flavoring which sickened hundreds of popcorn plant workers.

People I spoke to in NIOSH said that with a Democratic administration in power it may be easier for Howard to find the funding and support to allow his physicians, scientists and industrial hygienists to chase worker health issues that were unpopular with past administrations.

Transgenic rice fights pollen allergy

Fumio Takaiwa and colleagues write in this week’s Journal of Agricultural and Food Chemistry that the next generation of transgenic crops — “veggies and grains that produce higher levels of nutrients, such as vitamins and minerals, or even medicines and vaccines” — are being developed to directly benefit human health.

Great advances have been made, the scientists say, but admit they are “anxiously trying to determine whether foods produced from these ‘biopharmaceutical’ crops will be safe for humans and the environment.”

The scientists at Japan’s National Institute for Agrobiological Sciences have developed a transgenic rice plant that has been genetically engineered to fight allergies to Japanese cedar pollen. This is a growing public health problem in Japan that affects about 20 percent of the population.

After 26 weeks of animal studies, in which monkeys were fed the steamed rice, no health problems were seen with the allergy-fighting rice.

Human testing may be next, they say.

It will be interesting to see how long it takes before food safety advocates in the U.S. and elsewhere, weigh in on the new uses for genetically engineered crops.

I bet it won’t be long.

Here’s a link to the study.

Everyone knows about the about the tens of thousands of Chinese infants struck down but kidney-destroying melamine in their milk and the 60,000 dogs and cats worldwide who died after eating it in the pet food. Here are some other examples to consider:

Stinky tofu (yes, a real name) is a very popular street food throughout many Asian countries. Its aroma, which can bring the weak to their knees, comes from lengthy and thus costly fermentation. Chinese food authorities found that some tofu producers created the reeking odor with rancid water and sewage. The desirable dark color came from ten illegal chemical dyes.

Chicken and duck farmers added Sudan Red Dye IV to the feed used in their poultry operations. The dye, a cancer-causing agent banned in food in many countries, makes the yolks a vivid bright reddish orange, and is sought after as a special and costly treat.

Some of the Chinese verdors at the IFT expo. (c) a. schneider

Another egg fraud centers on another foul-smelling but very expensive and coveted traditional delicacy called a 1000-year-old egg. They’re really not preserved for ten centuries, but more like 100 to 150 days, according to a cook who gave me a bite of one in Vancouver. She said they normally are buried in a mixture of soil, lime, ashes, salt and green tea. Eventually, the egg white turns a gooey brown in color, and the yolk becomes dark grayish-green. But people love it.

Money hungry phony egg producers eliminate the waiting time and just add lead oxide to alter the eggs. However, the chemical can destroy blood, the central nervous system, kidneys and other organs as well as causing birth defects and convulsions.

Other inventive food suppliers, instead of using a higher quality flour, have been caught adding alum to strengthen noodles and borax to preserve rice cakes, while fish farmers use the cancer and birth defect-causing antibiotic and antifungal agent Malachite green to control disease in the fish they sell. Of course, there are the beekeepers who taint their honey by using illegal antibiotics in their hives.

“Everyone of these food adulterations can be attributed to economic motivation,” said Dr. Yao-wen Huang, a professor of food science at the University of Georgia. Most of the appealing examples mentioned above are his, and he and his colleague Hong Zhuang, a research food technologist for the USDA, were speaking at the International Institute of Food Technologists on food safety challenges in China.

The existing food safety system is not effective for a variety of reasons, including that 17 different bureaucracies work under the food and drug safety umbrella, and they each jealously guard their power, Huang explained but added, that 8o percent of China’s food producers are small operations employing fewer than 10 workers and most pay little attention to the few safety requirement that exist.

Not only is enforcement convoluted, but also the blurred lines of responsibility and weak investigatory skills are further hampered by corruption, with some inspectors and their bosses take bribes in exchange for favors, the professor told me.

Prof. Yao-Wen Huang

On June 1, China imposed a new food safety law.

Qin Zhenkui, president of the Chinese Academy of Inspection and Quarantine, believes the comprehensive requirements of the new law will make a difference.

Zhuang presented remarks from Zhenkui, which detailed the increased controls on food producers. These include inspection and licensing of all food manufacturers as well as rigorous requirements and previous state approval for all additives.

Food inspectors are not permitted to grant any exceptions to the rules, Zhuang explained.

This could eliminate, or at least reduce, the bribes for not seeing wrongdoing, but is that enough?

“The law should be an improvement,” Huang told me. “Everyone in the supply chain should be forced to get involved in ensuring the safety of the food — from the farmers, to the processors, the transporters, exporters and the importers themselves.

“’I didn’t know’ can no longer be an acceptable answer from anyone when it comes to food safety.”

This morning I stopped by nine exhibits of Chinese companies exporting food and asked representatives what they thought of their country’s two week-old food safety law.

Five sales agents told me that they’d never heard of it. The remaining four said the were forbidden to speak with the press, but one added, “China only sells the highest quality food. The problems in the press are fabricated.”

He wouldn’t give me his name.

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.”

The study by Bernard Herbreteau and his colleagues in Lyon, France was released this week in the Journal of Agricultural and Food Chemistry.

(c) Photo by a. schneider

“The high price, limited supply and complexity of honey combine to encourage falsification,” the scientists wrote. “Indeed, despite the technological advent of modern analytical instruments, there is still a problem with the adulteration of high-carbohydrate foods, such as honey, with inexpensive syrups.”

In the U.S., there are four major civilian labs and one government facility that claim the ability to identify adulterated honey.

Yet, when it comes to proving where the honey actually came from, criminal investigators, some U.S. regulators and a only a few of the largest domestic honey sellers send samples to a German lab. The lab says it’s the only place that can identify the precise country of origin of a honey.

Mostly, this analysis is needed to identify falsely labeled Chinese honey, which is smuggled into the U.S. after first being sent to other countries. The Chinese honey often contains illegal antibiotics, according to government authorities.

Criminal investigators from the FDA and Customs and Border Protection (that I interviewed last year) told me they were waiting for verification of the French test.

They hoped it would be faster, less expensive and more consistent and reliable than the laboratory analysis now available in the U.S.

Herbreteau and colleagues say their highly sensitive test uses a special type of chromatography to separate and identify complex sugars on their characteristic chemical fingerprints.

The most common syrups used to adulterate honey are corn syrups and high fructose corn syrup.

“Honey adulteration has evolved from the basic addition of sugar and water to specially produced syrups from which the chemical composition approximately reproduces the sugar composition and ratios of natural honey,” scientists wrote.

Here is a link if you want to see the actual study,

Links to investigative series on honey laundering by the Seattle Post-Intelligencer can be found on this website on the page called “previous investigations.”