A food scientist’s experiments could lead to the addition of the vitamin folic acid to corn-masa flour, a move that could help stop a growing number of fatal birth defects in three Washington counties.

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PROVO, Utah— In a commercial kitchen 800 miles from Washington state, food scientist Michael Dunn has spent this warm summer morning baking tortillas and frying corn chips.

Wearing a hair net, polo shirt and Wrangler jeans, the Brigham Young University professor explains that he’s testing a lifesaving intervention, nearly two decades overdue. As he loads the last batch of dough into the hopper, he sighs.

“This is it,” says Dunn, 53, watching as dozens of cream-colored tortillas, all made from corn-masa flour fortified with folic acid, slide on rollers to the waiting flames.

To residents of Central Washington, where a cluster of severe birth defects has left a community in fear and confounded public-health officials, Dunn’s far-flung experiment offers hope.

Since 2010, more than 40 women in Benton, Franklin and Yakima counties have lost babies to anencephaly, a rare disorder that leaves infants missing parts of their brain and skull. Last year, the rate in the region was 9.5 cases per 10,000 births, far higher than the national rate of 2.1 cases per 10,000.

No one knows exactly what’s causing the grim disorder in young Anglo and Hispanic women. But health experts point to low levels of folic acid, a supplement proven to prevent such neural-tube defects.

Editor’s note

This report is part of an occasional series focusing on a cluster of rare and fatal birth defects in three Central Washington counties.

Critics have been questioning for years why the crucial B vitamin isn’t routinely added to corn masa flour, or Maseca — a staple grain in Hispanic diets — the same way it has been added to enriched wheat and rice flour for years, sending U.S. birth-defect rates plummeting.

If Dunn’s tests perform as expected, his bagged tortillas and deep-fried chips could push the federal Food and Drug Administration to decide as soon as this year to allow folic-acid fortification of corn-masa flour — a move advocates say is the necessary first step to understanding and stopping the defects here and across the country.

“There is no question that Hispanic women are having babies with spina bifida and anencephaly because the FDA isn’t putting folic acid in the flour,” says Dr. Godfrey Oakley, a former director of the birth-defects division at the Centers for Disease Control and Prevention. “This is not just an Eastern Washington problem, but a national, global problem that has yet to be solved.”

In Washington, the lack of folic-acid fortification likely has worsened the ongoing cluster of anencephaly and made it difficult to tell what else — pesticide exposure, corn mold or nitrate in drinking water, for instance — may be contributing to the birth defects, Oakley says.

“Until we get the Maseca problem solved, it’s hard to say anything about that,” says Oakley, now the director of the Center for Spina Bifida Research, Prevention, and Policy at Emory University. “To go looking for something else in the meantime is ridiculous.”

Defects plunged after ’96

Oakley pioneered the effort in the late 1990s to add synthetic folic acid to grain products in the U.S., but the FDA declined at the time to include corn-masa flour in its ruling.

The corn flour wasn’t as common in the U.S. then as it is now and wasn’t defined in a way that allowed it to be treated as an enriched grain.

In 1996, the FDA ruled that cereal-grain products identified as enriched must be fortified with folic acid. After the regulation took full effect in 1998, cases of neural-tube defects fell by more than 35 percent in the U.S.

Overall, fortification eliminated about 10,000 neural-tube defects in a decade, making it one of the top 10 public-health interventions of the 20th century.

Today, about one in every 4,800 births in the U.S. is affected by anencephaly. Spina bifida is far more common, with about one in every 2,800 babies born with that defect.

I believe if we don’t do this now, we’re going to regret it. I think we already regret it.” - Michael Dunn, BYU professor

Adequate levels of folic acid are necessary to prevent such problems, ensuring proper formation of the neural tube, which creates the brain and spinal cord during fetal development. If the tube doesn’t close properly, it can cause spina bifida, or, in more extreme cases, anencephaly.

Folic acid is found in foods such as strawberries, asparagus, fresh spinach and beans and can be delivered through supplements, such as multivitamins. But it needs to be ingested in the earliest weeks of gestation, often before a woman knows she’s pregnant. Fortifying a staple grain, such as wheat, rice or corn, ensures a consistent, population-wide source of folic acid, experts say.

In 2012, a group of advocates including the March of Dimes, Spina Bifida Association and the American Academy of Pediatrics petitioned the FDA, demanding the agency allow voluntary folic-acid fortification of corn-masa flour.

The boost in folic-acid levels that would come with adding 140 micrograms of the vitamin to every 100 grams of corn-masa flour would prevent an average of 40 neural-tube defects in Hispanic women each year — and perhaps as many as 120 annually across the nation, CDC research showed.

“This is one area where we can definitively prevent a known birth defect,” says Cynthia Pellegrini, senior vice president of public policy for the March of Dimes Foundation.

Several countries already fortify corn-masa flour including Mexico, Brazil, Venezuela and most countries in Central America, according to the Food Fortification Initiative, an advocacy group. Costa Rica, for instance, saw a 35 percent drop in neural-tube defects after the fortification of wheat and corn flour in the late 1990s, but there aren’t good data on the effect of corn-flour fortification alone, according to a 2011 study in the American Journal of Public Health.

“A terrible policy error”

The March of Dimes’ petition has been pending at the FDA for more than three years, awaiting results of detailed studies on folic-acid stability. An FDA website reports that the petition is in abeyance, with no action scheduled.

“We admit, we have a certain degree of frustration with how long this petition is taking,” Pellegrini says. “We respect the FDA’s position to protect the public health. But, in the meantime, we are sacrificing opportunities to prevent birth defects.”

Oakley is more direct, calling the FDA’s failure to move forward on the issue “a terrible policy error” dating back two decades. The agency has dodged the problem, he said, allowing hundreds of children to be born with neural-tube defects in the meantime.

“To me, the real problem is people don’t focus on how bad this birth defect is,” Oakley says. “It kills babies and puts them in wheelchairs. People forget what a life-changing event it is to have a baby with anencephaly or spina bifida.”

FDA officials, however, say the agency is following a strict protocol for food additives, which affect the entire population.

“It’s not like we can just wave a magic wand and say something is lawful,” says Dennis Keefe, director of the Office of Food Additive Safety, adding: “The burden is on the industry to address the safety of the additive.”

Part of the problem has been money. The FDA-required safety and stability studies were originally estimated to cost nearly $1 million, Pellegrini says. No federal agency would fund the study and the nonprofit March of Dimes declined to pay the full bill, officials say.

That’s where Michael Dunn comes in.

A leading expert on micronutrients and fortification, Dunn was an early consultant on the FDA petition. After the project stalled, Dunn met with the FDA to discuss the agency’s demands, says Dr. Edward McCabe, medical director for the March of Dimes.

“Because he’s so well respected in the food-science community, he was able to negotiate the cost down to something the March of Dimes could afford,” says McCabe, noting that the current study will total not much more than $40,000.

Dunn also agreed to design and conduct the studies himself in conjunction with Oscar Pike, a fellow BYU food-science professor.

Adding 140 micrograms of folic acid to every 100 grams of corn-masa flour would prevent an average of 40 neural tube defects in Hispanic women each year — and perhaps as many as 120 annually across the nation, CDC research showed.

“Purely a safety decision”

The first step was launched in February with 3,000 pounds of corn-masa flour donated from Gruma Corp., Mexico’s leading manufacturer. It required blending batches of 300 pounds of corn-masa flour with about 0.2 grams of folic acid, adding the orange powder that looks something like the sauce mix in boxed macaroni and cheese. The scientists stirred it in using a special process and a multidirectional mixer, then let the flour sit to see whether the vitamin would change over time.

Corn-masa flour is made from dried corn kernels soaked in a solution of lime and water. Because the lime makes the masa flour more alkaline, there was concern that it would have an effect on the levels of the vitamin in the final product.

After three months of storage, there were no losses of folate, according to Dunn’s early results.

The second step required testing whether the folic acid degrades during cooking, including baking tortillas and deep-frying corn chips.

That brings Dunn to this borrowed commercial kitchen — a tortilleria operated by Rancho Markets, a chain of groceries catering to Hispanic customers in Southern Utah. Store owners agreed to participate in the study to help further research on neural-tube defects, which are about 20 percent more common in the Hispanic population.

Fernando Felix, manager of the Provo store, says he has a personal stake in the results because of a history of birth defects in his family.

“In Mexico, one of my cousins has a little niece with this issue,” he says.

With the help of Pike and two BYU students, Dunn spent a recent June morning mixing and cooking five batches of tortillas and chips, half fortified with folic acid, half without.

The cooked products will remain fresh for two months, Dunn says. He has shipped samples to a private lab, NP Analytical Laboratories in St. Louis. Dunn expects the folic acid will remain stable in the cooked samples, the last step, perhaps, to meet the FDA’s demands.

“I’m quite confident that once they receive the results from this study, they’ll come forward with the final rule,” says Dunn. “We’re just crossing that ‘T,’ basically.’  ”

That’s the hope, too, of Vickie Ybarra, a public-health nurse who spent 10 years visiting the homes of Hispanic women in Yakima, one of the three counties where the cluster has been detected.

“The whole thing has taken too long in my estimation,” says Ybarra, a member of the state advisory committee addressing the problem. “Not sure if that’s because FDA has been dragging feet or some other unknown reasons.”

Dunn says the FDA has been “too conservative” in its demands regarding corn-masa fortification, especially given the dramatic public-health benefit from enriched wheat and rice flours.

But Keefe counters that his office is compelled to focus solely on the additive.

“It’s purely a safety decision. It’s not a risk-benefit analysis like it is for pharmaceuticals,” he says. “Maybe we’re conservative, but we have to be conservative since we’re talking about food being consumed across the population daily.”

Results of the tests could be final by September; the FDA could consider the issue soon after, Keefe says. Dunn says it’s clear that the agency should move forward.

“I believe if we don’t do this now, we’re going to regret it,” he says. “I think we already regret it.”