Still drinking out of plastic bottles?

FDA says it's unable to regulate BPA As 'indirect food additive,' substance is exempt from scrutiny By Meg Kissinger of the Journal Sentinel Posted: Jan. 17, 2010 U.S. Food and Drug Administration officials say they are powerless to regulate BPA, although   they have declared the chemical to be a safety concern for fetuses, babies and young children. A quirk in the rules allows BPA makers to skirt federal regulation. "We may have to go after legislation to change it," Joshua Sharfstein, the FDA's principal deputy director, told the Journal Sentinel. The newspaper has been investigating the government's lack of regulation regarding BPA for three years.

FDA officials announced Friday that they had reversed their position that bisphenol A is safe. The chemical, used to line most food and beverage cans, has been found in the urine of 93% of Americans tested.

The agency now considers BPA to be of some concern for effects on the brain, behavior and prostate glands of fetuses and the very young. Scientific studies have raised concerns about the chemical's link to breast and prostate cancer, diabetes, obesity, heart disease, reproductive failures and behavioral problems.

The FDA did not ban the chemical, although top scientists, including Linda Birnbaum, director of the National Toxicology Program, say they consider the safety of BPA to be uncertain. An agency source says some from within the FDA wanted to follow Canada's lead and ban it from baby bottles - or from the lining of infant formula cans - but administration officials have resisted, concerned that babies who rely on bottled formula would be left without healthy alternatives.

"They couldn't take it off the shelves when there aren't substitutes in place," said the source, who asked not to be identified because the issue is so politically charged in the agency.

FDA officials - including Sharfstein; Lynn Goldmann, a consultant to the FDA; and Jesse Goodman, the FDA's acting chief scientist - told the Journal Sentinel they were frustrated by the antiquated framework of the FDA's regulatory process.

Officials say they would like chemical manufacturers to report information about the chemical to them, including how much BPA they produce and where and how it is used.

But because BPA was classified years ago as an indirect food additive, it is not subject to the kind of scrutiny that other chemicals are. Without critical data about BPA, it is impossible to regulate the chemical, officials said.

BPA, first manufactured in 1891, was later developed as a plasticizer in the early 1960s. It was classified in 1963 as an indirect food additive and is listed among some 3,000 chemicals that are "generally regarded as safe." That designation exempts them from scrutiny.

According to the FDA's regulations, a substance that is granted that status is not subject to FDA review.

So, while the agency can broadcast its opinion that the chemical is not safe, it can't compel companies to provide certain information about the chemical.

Given concern about BPA, and the ongoing evaluation and studies on its safety, the FDA thinks that the more modern framework is more robust and appropriate for oversight of BPA, agency officials say.

The FDA candidly explains the limitations on its Web site:

Current BPA food contact uses were approved under food additive regulations issued more than 40 years ago. This regulatory structure limits the oversight and flexibility of FDA.

Once a food additive is approved, any manufacturer of food or food packaging may use the food additive in accordance with the regulation. There is no requirement to notify FDA of that use.

For example, today there exist hundreds of different formulations for BPA-containing epoxy linings, which have varying characteristics. As currently regulated, manufacturers are not required to disclose to FDA the existence or nature of these formulations.

Furthermore, if FDA were to decide to revoke one or more approved uses, FDA would need to undertake what could be a lengthy process of rulemaking to accomplish this goal.

Changes needed

FDA Administrator Margaret Hamburg said the agency needs to overhaul its regulatory framework because the structure limits its ability to monitor BPA production.

"We need to be more nimble," she said.

Sharfstein, the deputy director, said the agency can try to get the companies to volunteer the information but might have to get a change in the law.

The FDA's admission of its inability to regulate the chemical should give muscle to legislative efforts for a ban, said Jon Peterson Myers, chief scientist for Environmental Health Sciences, who has advocated for a BPA ban.

"Industry always uses the argument that the chemical is regulated," Myers said. "This shows that it is not. State and federal lawmakers need to consider that. They can't rely on this agency to regulate it if they don't have the tools to do so."

Minnesota, Connecticut, the City of Chicago and two counties in New York have banned BPA in baby bottles. Other measures are being considered in 30 states and municipalities. A federal ban on BPA in all food contact has been proposed in Congress.

The Journal Sentinel obtained e-mails through the Freedom of Information Act that showed how the agency's look at BPA had been influenced by BPA makers.

The newspaper found that industry scientists wrote sections of the FDA's earlier draft declaring the chemical to be safe for all uses. It later obtained e-mails that showed industry lobbyists were given priority treatment in scrutinizing studies and that FDA regulators looked to them for advice on how to deal with the media.

The newspaper also uncovered documents that showed how BPA makers borrowed the same tactics and some of the same people as the tobacco industry to downplay the health risks of their products. In a meeting held in Washington, D.C., last May, food packaging executives mapped out a public relations strategy that included finding a pregnant woman to serve as a spokeswoman for the benefits of BPA. Notes referred to such a person as "the holy grail."

Last year, more than 6 billion pounds of BPA was made, representing nearly $7 billion in sales. U.S. companies that make BPA are Bayer Material Science; Dow Chemical Co.; SABIC Innovative Plastics (formerly GE Plastics); Hexion Specialty Chemicals; and Sunoco Chemicals.

Company officials have evaded questions about their product. Rep. John D. Dingell (D-Mich.) has written letters to BPA makers demanding information about their production levels but has gotten no reply.

"They absolutely stonewalled them, just like they stonewall anyone who wants information," said Fred vom Saal, a University of Missouri scientist who has advocated a ban of BPA. Vom Saal has debated against industry lobbyists at government hearings.

Chemical industry scientists maintain that BPA is safe. The American Chemistry Council, the lobby group for the chemical industry, issued a statement Friday saying that BPA is an important ingredient in preserving the integrity of food and drink.

The Obama administration committed $30 million to studies of BPA. The FDA's Sharfstein said the data is expected to be collected in the next 18 months to two years.

While the FDA considers how to deal with BPA makers, the market is moving away from using BPA in baby products. Last year, the six major baby bottle makers announced they would stop using the chemical in their products.

Susanne Rust, a former Journal Sentinel reporter involved in the paper's BPA investigation and now a freelance writer, contributed to this report.

Find this article at:  http://www.jsonline.com/watchdog/watchdogreports/81901927.html

Comments

[Morgan]

First of all the FDA should not have to worry about the BPA slipping through the cracks and still putting their product on the market. If the FDA has proven that the product that the BPA is making is harmful to fetuses, babies, and young children then BPA should have enough of a conscience to stop selling their product. This goes back to the insurance companies that we were talking about in class today and how they would turn down a dying patient just to get a bonus. It is ridiculous. If we cannot even stop selling harmful products or cover a patient's medical bill then there is really something wrong.

[Tyler]

"Last year, more than 6 billion pounds of BPA was made, representing nearly $7 billion in sales."

This fact, coupled with the Supreme Court decision that was made last week is a prime example of why instances such as this occurs. Why does this happen you say? I can read minds, "The companies say that their product doesn't cause harm, but scientists say that it does. Who is right?" Well...I think the real question is one that was brought up by Dr. Crenshaw in class--who has something to gain? That question usually has a clear answer and in this situation that holds true.

With $7 billion at stake and the right to donate money to a candidate, we will never see this ban enacted.

[cdavis17]

I really can't believe that this stuff (BPA) is still on the market...being sold to mothers who don't know! If there is any indication that this "food additive" can be harmful to babies and small children then WHY is it being sold?? Make bottles without this in there...I mean wouldn't that be a good solution, you are still making money with bottles, because there are plenty of babies that need bottles, but you aren't potentially harming the babies short term, and even long term health. But I guess people will even harm innocent babies for a couple extra dollars in their pocket.

[Sarah Thullbery]

The way in which many politicians demonize the idea of government intervention in health care by presenting government involvement as some absolute takeover of every aspect in society seems particularly ridiculous in light of this article. The FDA's inability to regulate BPA is disturbing because I think that most people assume that this is regulated though it is not. Because BPA affects infants - those who are the most vulnerable - it becomes even more important to regulate. Lobbyists should be experts who give politicians good advice and information, but instead many are corrupted by so much wealth from corporations.

[mgn]

It amazes me that even with the discovery that BPA has the possibility of causing serious effects on the brain, prostate glands of fetuses and the young yet still last year alone six million pounds of it was made grossing in about seven billion. That is outrages that companies are not preventing the production of BPA into their products especially when young children’s safety is at risk.
In the article when it says: “The FDA's Sharfstein said the data is expected to be collected in the next 18 months to two years” just does not seem good enough. I mean why wait instead of dealing with this problem right now when the issue is at hand? It’s like what was said in class today that we as Americans opt to often wait for a major crisis to occur before we bring about change to fix the problem.

[Brandon]

I don't see how BPA can still be on the shelves when we know it is harmful. They are saying we cannot take it off the shelves because there aren't any substitutes. But, we can leave them on the shelves to cause breast and prostate cancer, diabetes, obesity, heart disease, reproductive failures and behavioral problems in people. There has to be a problem with BPA because the company officials are avoiding questions. It sounds to me that they know BPA is harmful but it makes way too much money for anyone to admit it shouldn't be used.

[kmcnutt]

I think this is bogus. There are plenty of other options out there that don't include BPA. it's harmful, they know that, and still produce it. If I've learned one thing in this class thus far, it's that the people of the United States are greedy. Greedy beyond care of life and health.
I have plastic bottles called Nalgenes and Camelbaks. The have put labels in the side that say "BPA Free". When I walk into an outdoor store, for gear or anything else, I notice that there are plenty of bottles without BPA. So for them to say there is no solution is just lies. I think that products without BPA are a little more expensive, but when a mother is concerned for her child, I'm pretty sure they would choose a healthier option. If BPA is not taken out of bottles, it should be someone's duty to inform of this poison and let people choose. There are other options.

[Julie Jackson]

Wow. I am shocked. I cannot believe that BPA and baby bottles. You have got to be kidding me!! I liked how kmnutt said from this class she has learned that people of the United States are greedy. I totally agree. All people care about these days are themselves and money. The love of money is truly the root of all evil. How could someone be dumb enough to have BPA with baby bottles? Not even just baby bottles, bottles alone! Obviously BPA is a problem and we know that there are other solutions and ways to get around BPA. So why don't we do that? Ugh. These articles always make me mad and I am sick of these selfish hearted people. Also, I hate how they try to lie their way out of it. Thats so retarded.

[quicktype89]

I completely agree with what Katie has to say. There are options out there-just ask Canada what they use! Plus there is BPA free stuff even in Wal-Mart. The solution is there and easy to reach, and yes perhaps it is a little more expensive, but won't that help profit if it is the only option and SAFE! Obviously this is all driven by greed like EVERYTHING ELSE we have looked at. The worst part is that we are the lucky ones who carry this kind of information we are learning in class, so it is our duty to inform others. Sadly so many Americans are mis or uninformed, or just basically don't care enough to do anything about it because they can't see past the "next quarter" of their lives. We the informed must use this information to protect and that is where our current politicians fail because they have been bought out by companies like those who make BPA.

[Larz]

I can't believe this is happening and the companies know exactly what they are doing. It really is sad. And the fact that FDA let this go knowing just how dangerous it is. People are really greedy and only care about money in America, and it is horrible. And especially to little babies!! That is just heartless. Just like the insurance companies we have been watching in class, people in America are just looking out for themselves and their own money. When is this going to change and someone who can do something about it, do something!

[JohnEvans]

While this problem is grievous and unbelievable, I can understand the lack of outrage and activism among the populace. It seams like every where you look there's a product or service that can give you cancer or some other life threatening disease. And more are added to this list every day. I think people are tired of caring. No one can remember all of these unhealthy things, so why even try. As to the lobbyist issue, though I do not know what it is there ought to be some constitutional way to limit there influence. The best way I can think of to solve the greed issues in politics is to get rid of career politicians. We need to set term limits on all public offices. If a senator knew he could not be reelected he would be more willing to do what's right instead of worrying about pissing people off. This would also allow more smart but other wise average americans to get into office. Such a proposal would be almost impossible to pass and isn't fool proof but i think it could do a lot of good.

[David Cook]

Tyler has got it right. This ban is never going to be lifted because the powerful corporations have too much to gain than allow people the right to safely drink out of plastic bottles. Profits are far too important.

There really is no way to truly limit the amount of influence that the lobbyists have in our politics. The only way to do it would be to just truly ban them completely.