FDA proposes new arsenic ‘action level’ for US apple juice

By Ben BOUCKLEY contact

- Last updated on GMT

Picture Credit: Liz West/Flickr
Picture Credit: Liz West/Flickr

Related tags: Apple juice, Consumer protection

The US Food and Drug Administration (FDA) today proposed a new ‘action level’ to limit levels of inorganic arsenic in apple juice and said it thought it was possible to reduce exposure levels.

The new level of 10 parts per billion (ppb) is the same level set by the US Environmental Protection Agency (EPA) for arsenic in drinking water, and is a threshold providing guidance to industry.

Although the draft guidance, once finalized, is not legally binding, the FDA takes such action levels into account when considering enforcement action if it finds a product on sale that exceeds the threshold, and said it believes it is possible reduce arsenic exposure via apple juice still further.

Responding to the proposed new 10ppb limit, a spokesman for the Juice Products Association (JPA), which represents US juice processors, said that industry would carefully evaluate the FDA's proposed action level, the findings in its most recent sampling and analysis of apple juice, and the related risk assessment of inorganic arsenic.

Dr Urvashi Rangan, director of consumer safety and sustainabnility at consumer advocacy group Consumer Reports, which has pressed the FDA for action on arsenic in foodstuffs, welcomed the action as "reasonable first step in protecting consumers from unnecessary exposure to arsenic​".

"It also offers an important enforcement and accountability tool for regulators and a key benchmark for apple juice manufacturers,"​ he added.
Inorganic arsenic is present in the environment so can occur in foods, both as a naturally occurring mineral and because of activity such as past use of arsenic-containing pesticides.

Cancer, CVD, neurotoxicity, skin lesions…

As a known carcinogen, inorganic arsenic has been associated with skin lesions, developmental effects, cardiovascular disease, neurotoxicity, and diabetes.

Michael Taylor, the FDA’s deputy commissioner for foods and veterinary medicine: “While the levels of arsenic in apple juice are very low, the FDA is proposing an action level to help prevent public exposure to the occasional lots of apple juice with arsenic levels above those permitted in drinking water.”

Twenty years of FDA monitoring for arsenic had consistently found that apple juice samples contain low levels of arsenic, with few exceptions, the agency said.

But it added that new tools now allow it to better understand the breakdown between organic and inorganic arsenic levels.

60-day public comment window

In 2012 findings from the FDA’s latest dataset on 94 samples of arsenic in apple juice showed that 95% of apple juice samples tested were below 10 ppb total arsenic.

100% were below 10ppb for inorganic arsenic, the carcinogenic form of arsenic, and the JPA said the FDA data validated industry's own findings that apple juice was safe.

The proposed 10ppb levels considers this sampling data, the agency said, plus a recently completed peer-reviewed risk assessment of inorganic arsenic in apple juice (on the basis of lifetime exposure) conducted by FDA scientists.

The FDA said its new apple juice assessment used data from two studies published in 2010 and a 2011 evaluation by the Joint Expert Committee on Food Additives and Contaminants of the FAO, part of the UN and the WHO.

Since 2008 a ‘level of concern’ for arsenic of 23ppb in RTD apple juice has been in place, and the FDA has the authority to seize juices that exceed this level.

Over the next 60 days the FDA will accept public comments on the proposed action level (you can read its draft here​) and risk assessment on lifetime exposure to inorganic arsenic via apple juice.

Related topics: Regulation & Safety, Juice Drinks

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