DeLauro, Pallone Call for Release of FDA’s Guidelines Concerning Levels of Arsenic in Juice

GuidelinesCurrently Stalled Under Review at OMB

Washington, D.C. – In a letter sent yesterday,Representatives Congresswoman Rosa DeLauro (CT-03), Senior Democrat on theHouse Appropriations Subcommittee on Labor, Health, Human Services, andEducation, and Frank Pallone, Jr. (NJ-06), Senior Democrat on the House Energyand Commerce Health Subcommittee, requested that the U.S. Office of Managementand Budget (OMB) release the U.S. Food and Drug Administration's (FDA)voluntary industry guidelines for levels of arsenic in fruit juices. OMBis currently reviewing the document.

"We believe that while FDA should implement enforceablestandards for the maximum allowable levels of arsenic in rice and juice, theAgency's guidance document on arsenic in juice is an important first step thatwill inform and educate industry and consumers," state DeLauro and Pallone inthe letter. "We applaud FDA for its efforts to address the issue anddevelop new guidelines to reduce the risk posed by arsenic in applejuice. It is inexcusable that these guidelines are stalled whileconsumers continue to be exposed to potentially dangerous levels of arsenic."

In addition to calling for the release of FDA's voluntaryguidelines, DeLauro and Pallone introduced the Arsenic Prevention andProtection from Lead Exposure in Juice Act of 2012 or APPLE Juice Act of 2012" last Congress, which would require FDA to establish enforceable standardsfor arsenic and lead in fruit juices. The bill was introduced following aConsumer Reports study that revealed alarmingly high levels of arsenic and leadin apple and grape juice in New Jersey, New York and Connecticut. Inorganic arsenic is a known carcinogen that can increase the risk of bladder,lung, and skin cancers. DeLauro and Pallone plan to introduce a similarbill in the coming months.

Full text of theletter follows:

May 7, 2013

The Honorable Dominic Mancini

Deputy Administrator
Office of Information and Regulatory Affairs
Office of Management and Budget
Washington, D.C. 20503

Dear Deputy Administrator Mancini:

We write today to urge you to release the Food and Drug Administration (FDA)guidance document regarding arsenic levels in juice that is currently underreview at the Office of Information and Regulatory Affairs. Studies havefound concerning levels of arsenic in food and beverages which pose asignificant public health threat, especially to children. FDA's guidancedocument will be instrumental to industry and consumers alike as they attemptto address this public health issue.

Consumer Reports published an investigation in January 2012that found widely variable levels of arsenic and another heavy metal in juiceproducts purchased in Connecticut, New Jersey, and New York. Ten percentof the juices sampled contained arsenic, mostly inorganic arsenic, which exceededfederal drinking-water standards. As you may know, inorganic arsenic is aknown carcinogen that can increase the risk of bladder, lung, and skincancers. The findings are particularly worrisome because children consumelarge quantities of juice and may be at more risk for harmful effects frominorganic arsenic exposure.

We believe that while FDA should implement enforceablestandards for the maximum allowable levels of arsenic in rice and juice, theAgency's guidance document on arsenic in juice is an important first step thatwill inform and educate industry and consumers.

We applaud FDA for its efforts to address the issue anddevelop new guidelines to reduce the risk posed by arsenic in applejuice. It is inexcusable that these guidelines are stalled whileconsumers continue to be exposed to potentially dangerous levels ofarsenic. We look forward to your expeditious review and timely release ofthis guidance document so FDA can better fulfill its mission of protecting andpromoting the public health.

Thank you for your prompt attention to this matter.

Sincerely,

Frank Pallone,Jr. Rosa L. DeLauro

Member ofCongress Member of Congress