켐론FDA코리아

미국FDA 비스페놀A(BPA) 규제방안 검토중

(Health Agencies Express Concern Over BPA : 2010년 1월 15일) 
 

미 FDA와 다른 보건 기관들은 플라스틱 제품에서 나오는 비스페놀 A이 건강에 미치는 영향을 규명하기 위해 단기 그리고 장기적인 연구에 30,000만 달러를 투입하고 있다. 

미 정부 보건 관련 기관인 HHS와 FDA에서 플라스틱 재질의 제품에서 나오는 호르몬 장애, 비만, 심장병과 관련성이 있다고 믿어지는 비스페놀A(Bisphenol A : BPA)에 대한 우려를 나타냈다는 포스트이며, 2007년도에 전문가위원회의 BPA가 인체 건강상 우려할 점이 없다고 말한 것과는 사뭇 다른 내용이다.
 
 
미 FDA와 다른 보건 기관들은 플라스틱 제품에서 나오는 비스페놀 A이 건강에 미치는 영향을 규명하기 위해 단기 그리고 장기적인 연구에 30,000만 달러를 투입하고 있다. 


비스페놀 A는 통조림 통의 접착제뿐만 아니라 유아 젖병과 시피컵 (Sippy cup)을 포함한 플라스틱 제품 등 어디에나 포함되어 있다. 비스페놀 A는 과거 1~2년 동안 건강 및 발달 장애의 주된 원인으로 이것을 연관 짓는 여러 연구들에 통해 정밀조사가 진행되어 왔다.  

"최근 보고서들에 따르면, 동물 실험으로부터 낮은 수준의 비스페놀 A도 동물에 미묘한 영향을 보였으며, 이것에 대한 우려가 높아져 깊은 관심을 가지고 있다." 고 Bill Corr(미 보건복지부 (HHS) 차관) 및 FDA 담당자들은 전했다. "비스페놀A가 우리 아이들에 대해 미치는 잠재적인 영향을 이해하기 위한 좀 더 많은 연구가 필요하다고" 그는 말했다. 

그 동안 FDA는 이 화학물질에 대한 우려가 높아졌다는 언급을 하지 않았었다. 하지만 지금 FDA의 Bill Corr는 "아이들과 어른에 대한 BPA의 위해성이 입증되지 않았지만, 기존의 데이터를 충분히 검토할 필요가 있다. 왜냐하면, 아이들은 초기 발육 시기에 노출되기 때문이다."라고 말하고 있다.

한 마디로 말해, BPA가 가지고 있는 잠재적인 위험성에 대해 만약 그것이 안전하지 않았다면, FDA에서 강한 규제 방안이 정해질 것이라고 말하고 있다.

FRIDAY, Jan. 15 (HealthDay News) -- The U.S. Food and Drug Administration and other U.S. health agencies are pledging $30 million toward short- and long-term research aimed at clarifying the health effects of the plastics chemical bisphenol A (BPA).

The chemical is ubiquitous in plastic products, including baby bottles and sippy cups, as well as metal linings of some cans, including those containing infant formula. And it has come under close scrutiny in the past year or two with studies linking it to a host of health and developmental problems.

"Recent reports show subtle effects of low doses of BPA in laboratory animals and that has raised concerns so we now are taking a much closer look at BPA," said Bill Corr, deputy secretary of the U.S. Department of Health and Human Services (HHS), the umbrella organization for the U.S. Food and Drug Administration and other agencies. "We need more research to understand the potential effects on children," he said.

Corr and other officials spoke at a Friday afternoon news conference.

The FDA stopped short of stating that it was raising its level of concern about the chemical.

"BPA has not been proven to harm either children or adults," Corr said. "But the data deserves a much closer look because children are being exposed at early states of development."

"In a word, FDA does support the use of bottles with BPA because the benefit of nutrition outweighs the potential of risk of BPA," said Dr. Joshua Sharfstein, principal deputy commissioner of the FDA. "If we thought it was unsafe, we would be taking strong regulatory action."

Sharfstein added that 90 percent of baby bottles manufactured for the U.S. market no longer contain BPA.

In studies released over the past two years, BPA has been linked to heart disease, sexual dysfunction, cancer, diabetes and hyperactivity, as well as aggression in girls. There is also concern that it could have an effect on the developing fetus.

According to FDA Commissioner Dr. Margaret Hamburg, the agency "shared the perspective of the National Toxicology Program of some concern of health effects of BPA."

The National Toxicology Program's 2008 report on BPA used more current data and raised more concern than an FDA report on BPA, leading to criticism of the FDA document.

In the NTP report, experts expressed "some concern for effects on the brain, behavior, and prostate gland in fetuses, infants, and children at current human exposures to bisphenol A."

"What's happening today is the FDA is saying that our perspective is now in line with [the NTP assessment]," Scharfstein said. "We have some concern in areas they had some concern and are taking action based on that level of concern to understand more about BPA."

Sharfstein said the agency was also looking also at new regulatory frameworks for BPA, so that officials could act more quickly on the chemical if warranted.

Until the agencies "answer key question and clarify uncertainties about BPA," the FDA is "taking reasonable steps to reduce human exposure to BPA, supporting industry's action to remove BPA from baby bottles and cups, facilitating alternatives to BPA for lining of cans, and supporting efforts to remove or minimize BPA in other food can linings," Hamburg said.

Corr detaied four steps that consumers can take to reduce their BPA exposure:

• As recommended by the American Academy of Pediatrics, babies should be breast-fed for 12 months if possible. The safest and most nutritious alternative is iron-fortified infant formula, even if there are trace amounts of BPA.
  
• Discard scratched baby bottles and cups as they may harbor germs and may release small amounts of BPA.
  
• Very hot infant formula should not be put into BPA-containing bottles as BPA could leach from the container to the food.
• Check labels of all bottles and cups to make sure they are microwave and dishwasher safe.
  

SOURCES: Jan. 15, 2010 teleconference with William Corr, deputy secretary, U.S. Department of Health and Human Services; Margaret Hamburg, M.D., commissioner, U.S. Food and Drug Administration; and Josh Sharfstein, M.D., principal deputy commissioner, FDA