Center for Food Safety Pressuring FDA to Create New Regs to Limit Cumulative Arsenic Exposure

The Center for Food Safety (CFS) has been pressuring the U.S. Food and Drug Administration for years on various fronts to create more concrete regulations to protect Americans from exposure to arsenic found in common grains like rice, produce such as apples and grapes, and drinks including water and fruit juices.

In its most recent action, the CFS has filed a lawsuit against the FDA calling for the withdrawal of arsenic containing feed additives for chickens, turkeys, and hogs.

The CFS has given one of the best explanations of what arsenic is. It’s an odorless and tasteless semi-metal element that occurs in the environment as part of the earth’s crust.

Arsenic can be found in rocks, soil, water, air, plants, and animals, and can be released into the environment through natural processes such as volcanic eruptions, rocks eroding, forest fires, and human activities. Arsenic can appear in inorganic and organic forms.

The CFS says that at one time, organic arsenic was considered less toxic than inorganic arsenic and safe at low levels, which has now been proven wrong.

The non-profit adds that, “Recent studies show that organic arsenic can easily convert to inorganic arsenic in the environment and in the body when ingested by humans and animals.”

Inorganic arsenic, according to the Centers for Disease Control and Prevention (CDC), is formed when elemental arsenic in the environment is combined with oxygen, chlorine, and sulfur. Inorganic arsenic is a known carcinogen, but can cause a host of other health problems as well.

The FDA says that, “Long-term exposure to high levels of arsenic is associated with higher rates of skin, bladder, and lung cancers, as well as heart disease.” The CDC adds that arsenic can also affect the digestive system, liver, nervous system, and respiratory system from the nose to the lungs.

Research at the CFS has found that “children, infants, and fetuses are among the most vulnerable to arsenic’s toxic effects” due to the differences in their metabolism from adults early in life.

The non-profit added that, “Carcinogens like arsenic are generally more potent in early life exposures” and that, “Children ages two to five are three times more vulnerable to carcinogens than adults.”

The CFS went on to say that evidence shows that arsenic is a hormone disruptor at very low levels, which can alter the way that hormones transmit information between cells.

Consumer Reports, through its own research also explained how arsenic exposure can affect a child saying that, “when arsenic exposure occurs in the womb or in early childhood, it not only increases cancer risks later in life, but also can cause lasting harm to children’s developing brains and endocrine and immune system, leading to other diseases, too.”

While arsenic is naturally found in nature, in recent years it has also been intentionally added to the American diet. Historically, arsenic has been approved for extensive use in animal feeds and pesticides.

Overcrowded chickens in factory farm. Photo courtesy of takepart.com.

The CFS reported that, “Thousands of animal feeding operations in the U.S. can use arsenic-containing feed additives to increase weight gain, improve pigmentation in animals, or to prevent and control diseases among animals that are raised in crowded, stress-induced conditions that promote diseases.”

The CFS also found in its 2013 study that the arsenic drug roxarsone was detected in half of the conventional chicken samples and in one out of 13 of the conventional antibiotic-free samples.

In addition, the study found that conventional samples had higher inorganic arsenic concentrations than the antibiotic-free and organic samples. The CFS also said that “perhaps most concerning” was that the “total arsenic and inorganic arsenic concentrations were significantly higher in cooked samples than raw meat samples.”

While the FDA will not admit to feeling pressure from the CFS lawsuit to make changes to its policies regarding the use of arsenic, the federal agency has announced a major reversal.

The federal agency responded to CFS, telling it that the sponsors of the arsenic-containing drugs roxarsone, carbarsone, and arsanilic acid have requested that these drugs be pulled from the market, so the non-profit’s withdrawal request is “moot.”

The agency did though also tell the CFS that it was denying its petition for the withdrawal of the arsenic containing drug nitarsone.  The FDA justified its decision saying that, “The scientific evidence at the time of approval of all four arsenic-based animal drugs indicated that animals exposed to organic arsenic rapidly excrete the compound in its original form – as organic arsenic.”

The FDA though added that it “believes, as a matter of science and regulatory policy, that the most appropriate course of action at this time is to continue to pursue the agency’s scientific research and evaluation.”

The agency continued that it is seeking additional information to enable it to more fully evaluate any potential concerns related to the safety of arsenic-based animal drugs, which will include requiring the sponsor of nitarsone to submit any data and information in its possession related to whether inorganic arsenic can be detected in edible tissues; whether organic arsenic converts to inorganic arsenic in vivo in any animals administered the drug; and whether and to what extent information related to the behavior of one arsenic-based animal drug is applicable to other arsenic based drugs.

Earlier this year, the FDA also proposed an “action level,” which is basically a voluntary industry guidance to limit inorganic arsenic to 10 parts per billion (ppb) in apple juice, which is the same level set by the U.S. Environmental Protection Agency for drinking water.

The CFS complains that, “In contrast to regulations, action levels are not binding on the courts, the public (including food and feed producers, or the agency (including individual FDA employees) and do not have the force of law of substantive rules.

“Voluntary oversight schemes such as this have an abysmal record of failure, in part because they do not create any incentive to change within the regulated industry. The FDA has the authority to issue binding regulations setting limits on arsenic levels in apple juice.”

Consumer Union, the advocacy arm of Consumer Reports, is urging the FDA to set arsenic limits for apple and grape juice to no more than 3 ppb. The group adds that, “Apple and grape juice constitutes a significant source of dietary exposure to arsenic. Children drink a lot of juice. Thirty-five percent of children five and younger drink juice in quantities exceeding pediatricians’ recommendations.”

The CFS further criticized that the “FDA’s proposed action level for organic arsenic in apple juice of 10 ppb is insufficient to address the cumulative health hazards that both organic and inorganic arsenic pose to consumers.”

The CFS added that, “Even if such a standard were protective of consumers whose only source of arsenic is apple juice, it would still be insufficient to protect consumers who consume apple juice in addition to other staples such as water, rice, and chicken.” The non-profit said that it would ultimately like to see the agency “regulate based on cumulative arsenic exposure rather than through product specific levels.”

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