Arsenic in Apple Juice: Action Level

December 6, 2013

Table of Contents

Description of Proposal
Background
Problem Analysis
Cons
Flaws in Studies Used Flaws in Methodology Limit Unattainable Unintended consequences
Pros
Recommendation
Works Cited

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Description of Proposal

The FDA has proposed a reduced limit on the inorganic arsenic present in apple juice in order to protect human health and believes the standard is attainable through the use of good manufacturing processes (US FDA, 2013).

Background

Arsenic is an element present in the environment from both anthropogenic and natural sources. It can be found in two different forms, organic and inorganic, which together are called total arsenic. Inorganic arsenic is considered to be the more toxic of the two, and consumption has been linked to cancer, skin lesions, developmental effects, cardiovascular disease, neurotoxicity, and diabetes in humans. Organic arsenic can turn into inorganic arsenic in the environment and in the body through digestion by people or animals. Apple juice is just one example of a food exposed to arsenic, which is likely due to the contaminated soil the crop grew in. While some manufacturers may be able to make changes and reduce arsenic levels, it is often hard or even impossible to trace arsenic back to a specific cause. Apple juice poses a greater threat to children since they often consume more of the drink in relation to their body weight and their diets are less varied (Environmental Health, 2010) (US FDA, 2013).
In 2008, as a part of a hazard assessment by the FDA, a level of concern was established at 23 ppb of inorganic arsenic in apple juices that are ready to drink. This regulation was based on non-cancer end points, such as cardiovascular and dermatological effects, and average consumption of apple juice with higher levels of arsenic for a limited period of time. The FDA has routinely monitored arsenic levels in apple juice in past years, and has found samples with levels above 10 ppb in the past. However, in one of their most recent surveys in fiscal year 2011, none of the 94 samples tested had inorganic levels of arsenic above 10 ppb. The FDA still believes that levels can be reduced further. It initiated a new quantitative risk assessment for inorganic arsenic, with the new focus of cancer endpoints and based on chronic and lifetime exposure (US FDA, 2013).
The FDA has drafted guidance on an action level of 10 ppb because the association considers this to attainable using good manufacturing practices, and levels should not exceed this level unless the manufacturer is being careless. This action level can reduce human exposure and be protective of public health. The FDA tests samples first for total arsenic levels because the process is easier. Then if the total arsenic level is above 10 ppb, the FDA will do a different test on the sample to determine levels of inorganic arsenic. For juices that are imported, the FDA conducts targeted screenings through its import alert program. Under this program, FDA District Offices may detain certain imported fruit juices and concentrates from specified firms, without physical examination. Companies from Argentina have an alert for arsenic in apple juice and concentrate, as well as firms from China for pear juice and concentrate (US FDA, 2013).
Apple juice is not the only product subject to new regulation; the FDA has imposed a maximum level of 10 ppb for bottled water in 2005, based on the same level established by the EPA on public drinking water in 2002(US FDA, 2013). In 2012, the cleverly titled Arsenic Prevention and Protection from Lead Exposure in Juice Act, or APPLE Juice Act of 2012, was introduced. The act would require the FDA to issue regulations setting tolerance levels of arsenic and lead in fruit juices within two years, but it was never passed (Tomaselli, 2013) This came not long after Dr. Oz claimed to have found “troubling levels of arsenic” in juice on his show. The FDA tested the same batches, and found normal levels consistent with regulation, however, the show still caused a panic among consumers (CBSNews, 2013). This new level of concern, which was not apparent before the episode, spread very quickly and attracted lots of media attention.

Problem Analysis

Market failure is not apparent in this situation; therefore, the non-economic rationale for intervention is paternalism (Beales, 2012). The problem is rather widespread, as low levels of arsenic are present in many foods and beverages throughout the world. Arsenic contamination can be caused by many different manmade or natural activities. Natural sources include volcanic activity, weathering of arsenic-containing metals, and dissolved in groundwater. Varying levels can be found in food, water, soil, and air. It is absorbed by all plants, especially in leafy vegetables, rice, apple and grape juice, and seafood. It is also used in mining, commercial and industrial processes, and is a byproduct of smelting. Industrial activities may also lead to atmospheric deposition of the element in soil (Environmental Health, 2010). Other possible origins of inorganic arsenic include processing aids of the juice, prior use of arsenic-based pesticides on the land now used for apple orchards, or even current use arsenic-based pesticides in other countries. The juice may even be exposed to arsenic in the manufacturing process if the water used to dilute it is not arsenic free. This type of contamination may be preventable by manufacturers by simply switching to water with low or no arsenic levels (tap water in the US has a limit of 10 ppb)(US FDA, 2013). However, if water is not found to be the source of the problem, it is extremely difficult to trace back. Apple juice or apple juice concentrate inputs are fresh produce which is mixed at many different stages, including packing since apples are purchased from many different farms and mixed before being processed (Beales, 2012). Although arsenic is widely known to be dangerous in high doses, low dose effects are difficult to determine and are widely debated. There are a vast number of studies indicating that chronic exposure to inorganic arsenic less than 100-150 ppb have no effect on humans (Cohen, 2013). These are widely disputed, with many people very concerned over especially vulnerable groups, such as children and pregnant women; their argument is typically that arsenic is a dangerous element and should be eliminated completely, or to the best of our abilities (US FDA, 2013). However, science and our knowledge of arsenic is increasingly evolving, so a conclusive answer is difficult to produce. The main long-term risk associated with inorganic arsenic exposure is cancer, which is difficult to directly connect to apple juice consumption since so many things in our daily lives present similar, if not worse, risks. No instances of apple juice related deaths or illnesses have been reported, so it is safe to say that this is not a huge problem that needs immediate attention. If the FDA is genuinely concerned, they should impose limits on inorganic arsenic in all foods and beverages, not just one extremely specific product.

Cons
Flaws in Studies Used The majority of comments, whether for or against the proposed guidance, mention many flaws within the studies utilized to determine the new action level. The FDA used studies done in rural Taiwan and Bangladesh, which may “significantly modify” the response to inorganic arsenic in comparison to a US population. Population differences, including BMI, macro- and micronutrients were not taken into account (Cohen, 2013). Nutritional status, which varies greatly between the two, is an important determinant in the metabolism and potential toxicity of ingested inorganic arsenic (Lonardo, 2013). Genetic variation between the two is also crucial to address, as similar concentrations of the element may result in different results. A study in the US of populations exposed to inorganic arsenic similar to the Taiwanese study showed no increase in bladder and lung cancers. Another variation among the populations that needs to be taken into account may be background rates of cancer (Lonardo, 2013). An additional issue in the studies is that the actual dose each individual is exposed to is estimated-rather than controlled-meaning estimates may be biased (Freysinger, 2013). The studies also do not show differences between genders, while other assessments indicate that women are at a consistently higher risk than men, which the FDA makes no mention of (Rangan, 2013).

Flaws in Methodology
Most comments also agreed that the methodology used to determine the new action level is incorrect, thus lacking scientific basis. The Grocery Manufacturers Association (an advocate of more than 300 leading food, beverage, and consumer product companies in the US and around the world) explains why in a very simple manner; linear or non-threshold assessments are used for carcinogens known to react directly with DNA, which inorganic arsenic does not do. Thus, the model used by the FDA is not appropriate and a nonlinear, threshold model should be used to get accurate results (Lonardo, 2013). Dr. Samuel Cohen, a distinguished professor of oncology who has studied the effects of arsenic for about 20 years, goes into a much deeper scientific explanation in his work. He also supports the use of a nonlinear, threshold dose response model to get more accurate results, as the linear approach used by the FDA may overestimate risk at low exposure levels (Cohen, 2013) (Vaughan, 2013). Large amounts of data supporting the lack of increased cancer risk at less than 100-150 ppb is neither considered, nor even addressed by the FDA, as pointed out by the Arsenic Science Task Force (Cohen, 2013). The agency’s ignorance of the newer, more appropriate method of analysis and relevant evidence makes the low action level unnecessarily conservative (Roberts, 2013) The FDA’s analysis also implies positive excess risks at all positive concentrations, which is misleading since no elevated risks have been observed for low concentrations. Their data also implies that there is zero probability of zero excess risk, even though multiple epidemiological studies in the US and Europe report otherwise (Freysinger, 2013).
The FDA’s analysis and studies it is based on show no causal analysis, and thus cannot forge a relationship between exposure and response. Because there is no causal analysis, the Juice Products Association finds the FDA’s proposed guidance scientifically unjustified as it implicates a cancer risk that no evidence demonstrates is directly caused by consuming apple juice (Freysinger, 2013). It is also pointed out that basing guidelines for apple juice on those of water may not be appropriate since water is consumed in much larger quantities. Apple juice is also absorbed by the body much differently than water, so the risk may be overestimated, and again, unnecessarily conservative (Vaughan, 2013).
Consumer Reports conducted their own survey of households, and has determined the FDA’s estimates for intake are significantly less than their findings. They insist that the 3x multiplier used for high-volume consumers is more accurate (high volume intake of 8.1 oz/day). This would mean that the FDA grossly underestimated intake, which may mean risk is also underestimated (Rangan, 2013). On the other hand, JPA pointed out that the risk assessment uses a higher consumption rate of water per day of three liters versus the EPA’s rate of one liter per day for children under 10, which includes juices and other beverages, not just water (Freysinger, 2013). These differences expose a distortion in estimates of consumption, raising doubts as to which to believe.
Many comments also questioned why only this one very specific product was being targeted. Other foods such as rice, are typically higher in inorganic arsenic levels and are a staple in many people’s diets, yet remain unregulated. The FDA must address this regulatory inconsistency (Vaughan, 2013) (Miller, 2013).
Unattainable Limit While the FDA believes that the 10 ppb guidance is attainable, an important commenter argues on the contrary. The European Fruit Juice Association does not believe the proposed limit is attainable globally, citing a study that shows 54% of 1523 samples were above the 10 ppb limit, but that total arsenic levels have declined in the past three years (Hermans, 2013). This raises concerns for international suppliers, as they may be shut out due to this non-tariff import barrier. Higher prices of juice and juice products will likely be a burden the consumers will be forced to pay. Even if international producers are able to reduce the amount of inorganic arsenic in juices, since the import alert program allows for detention without physical examination, it is unclear how long it will take for the targeted countries to be taken off the list (FDA, 2013). This may cause some tension internationally.
Unintended Consequences Many sources fear that the policy would have serious unintended consequences, such as consumers losing confidence in food safety without actually promoting public health. This may lead to dietary changes for the worse; media coverage may encourage avoidance of this contaminant, increasing consumption of alternatives, which may have their own contaminants and not be any safer (Vaughan, 2013). Even juice processors may switch to alternative types of juice, which could be higher in arsenic levels, to replace apple juice in blended products.
Even if the FDA does adopt similar guidance on other juices or products in the future, varying limits will be confusing for the customer. A standard limit for all fruit juices, if not all products, would eliminate potential confusion as well as the likelihood of switching to worse alternatives (Lonardo, 2013) (Miller, 2013).
A guidance lowering contaminants may lead to customers consuming more apple juice than before, increasing their exposure to inorganic arsenic (Beales, 2012). An increased intake can eventually result in other unforeseen effects, such as weight gain from sugary juices.
Lower limits may lead to manufacturers to switch to other chemicals, which may be more dangerous in the long term. Manufacturers may also be forced to use purification systems to eliminate or reduce the arsenic, which produces a sludge that is very difficult to dispose of (Environmental Health, 2010). This may present a threat to the environment, since not all firms will be able to afford the most environmentally friendly systems or ensure proper disposal.
Although the majority of apple juices already meet the proposed 10 ppb limit, those who do not may struggle to meet the recommendation. Since in some areas the arsenic level in soil may be naturally high, producers with orchards in these areas may not be able to feasibly meet this limit, and may be shut out of the market unnecessarily (Environmental Health, 2010). This may lead to disruptions to the market for apples in the US as well as internationally, and in turn higher prices for the consumer. These many flaws must be addressed by the FDA in order for the policy to be “developed utilizing sound science (Seetin, 2013).” The guidance must be risk-based in that it demonstrates through sound science that inorganic arsenic levels above 10 ppb, and below 23 ppb, put any segment at an elevated risk (Vaughan, 2013) (Seetin, 2013).

Pros

On the contrary, many argue that since this lower level is attainable, that is enough to justify implementation. Many are concerned with long-term effects, and believe that the FDA should err on the side of caution in order to protect the most vulnerable populations, even if the evidence is not completely conclusive. Since arsenic is known to be dangerous, it should not be tolerated even at low levels. Most urge similar, or even lower, binding limits on juice and other products (McInerny, 2013). Consumer Reports has done their own research and has more extensive recommendations. They support the action level of 10 ppb but believe that since the majority of the industry is already under this concentration, it should be set even lower. Their cancer risk assessment supports a 3 ppb limit, or 4.4 ppb at most, and should establish a goal level for arsenic in food at 0 ppb to incentivize companies (Rangan, 2013). Passing of this guidance may be a good first step in protecting consumers from contaminants. It may lead to limits on inorganic arsenic in other foods, which may contain higher levels. There may even be spillover effects to regulate other contaminants, which will benefit the health of the population in the long run. Since protection from potentially dangerous contaminants is generally seen as a good thing, it is not surprising to find a petition with 1,176 signatures from people all over the US submitted in support of the proposed limits (Burke, 2013).

Recommendation

The numerous flaws found in the proposed guidance are impossible to ignore, and therefore, it should not be passed. Instead, the FDA must go back and revaluate its methods according to the comments. Then, once backed by appropriate and consistent science, it should propose a new guidance, if necessary, based on the new and more accurate findings. When the guidance is more soundly backed and contains irrefutable analysis and methods, it should pass with little pushback since most associations agreed with the concern and stated they would comply (Vaughan, 2013) (Lonardo, 2013). The new guidance should cover more products, not just one specific beverage. Inorganic arsenic can be found in other products that babies and young children are even more exposed to, including baby food; therefore it makes no sense to target just apple juice. Although it may be necessary to separate by type, action levels should be applied uniformly if inorganic arsenic is found to be an important source of concern. Furthermore, if this contaminant really does have dangerous health risks, the FDA should propose actual regulation limits instead of a mere guidance. This would allow the FDA to more effectively enforce standards. In addition, due to the FDA’s recent stricter enforcement and penalties, sellers will likely try to ensure their product is safe rather than risk prosecution (Karst, 2013). During their investigation, the FDA should stress that apple juice is still safe to consume in order to minimize panic and unintended consequences. They may also encourage kids to eat fresh fruit, and remind everyone that juice is not essential to kids diets and should be limited (McInerny, 2013). Reliance on shows such as Dr. Oz should be discouraged as they often make over exaggerated claims backed by pseudoscience to attract attention and viewers, and to keep them coming back. Bogus claims often scare consumers, and may cause widespread panic and unintended consequences. Consumers need to be wary of these publicity stunts and should always consult a doctor. In conclusion, the proposed guidance to limit inorganic arsenic in apple juice should be changed. While I do believe that the elimination of unnecessary health risks is beneficial overall, the FDA must substantiate its proposition with more appropriate and conclusive science-based evidence. Again, if inorganic arsenic is found to be as dangerous as believed, it should be eliminated from all foods and beverages to the best of our ability, not just apple juice.

Works Cited
Beales, Howard. Business and Government Relations: An Economic Perspective. [S.l.]: Kendall Hunt, 2012. Print.
Beales, Howard. "Rationales for Government Intervention." Business and Government Relations: An Economic Perspective. [S.l.]: Kendall Hunt, 2012. 18-19. Print.
Burke, Paul. "Paul Burke - (Multiple Signatures = 1176) Form Letter Comment." Letter to US FDA. 11 Sept. 2013. Regulations.gov. N.p., 12 Sept. 2013. Web. 30 Nov. 2013. <http://www.regulations.gov/#!documentDetail;D=FDA-2012-D-0322-0007>.
Cohen, Samuel, Dr. "Comments on Draft Industry Guidance-Samuel Cohen." Letter to US FDA. 9 Sept. 2013. Regulations.gov. N.p., 12 Sept. 2013. Web. 28 Nov. 2013. <http://www.regulations.gov/#!documentDetail;D=FDA-2012-D-0322-0006>.
"Dr. Oz Slammed over Apple Juice Arsenic Warning." CBSNews. CBS Interactive, 6 Sept. 2011. Web. 03 Dec. 2013. <http://www.cbsnews.com/news/dr-oz-slammed-over-apple-juice-arsenic-warning/>.
"Environmental Health and Medicine Education." Arsenic Toxicity Case Study: Home Page. N.p., 15 Jan. 2010. Web. 30 Nov. 2013. <http://www.atsdr.cdc.gov/csem/csem.asp?csem=1>.
Freysinger, Carol. "Juice Products Association Comment." Letter to US FDA. 11 Nov. 2013. Regulations.gov. N.p., 3 Dec. 2013. Web. 3 Dec. 2013. <http://www.regulations.gov/#!documentDetail;D=FDA-2012-D-0322-0020>.
Hermans, Jan. "AIJN - European Fruit Juice Association - Comment." Letter to US FDA. 10 Oct. 2013. Regulations.gov. N.p., 23 Oct. 2013. Web. 29 Nov. 2013. <http://www.regulations.gov/#!documentDetail;D=FDA-2012-D-0322-0011>.
Karst, Tom. "FDA Ups Criminal Prosecution for Food Safety Violations." - The Packer. N.p., 4 Dec. 2013. Web. 04 Dec. 2013. <http://www.thepacker.com/fruit-vegetable-news/FDA-ups-criminal-prosecution-for-food-safety-violations-234668161.html>.
Lonardo, Emilia, Ph.D. "Comment from Grocery Manufacturers Association GMA." Letter to US FDA. 8 Nov. 2013. Regulations.gov. N.p., 16 Nov. 2013. Web. 28 Nov. 2013. <http://www.regulations.gov/#!documentDetail;D=FDA-2012-D-0322-0018>.
McInerny, Thomas K., M.D. "American Academy of Pediatrics - Comment." Letter to Commissioner Margaret Hamburg. 12 Sept. 2013. Regulations.gov. N.p., 23 Oct. 2013. Web. 30 Nov. 2013. <http://www.regulations.gov/#!documentDetail;D=FDA-2012-D-0322-0009>.
Miller, Pamela, RN, MS. "Pamela Miller McDaniel, RN, MS - Comment." Letter to US FDA. 25 July 2013. Regulations.gov. N.p., 6 Aug. 2013. Web. 28 Nov. 2013. <http://www.regulations.gov/#!documentDetail;D=FDA-2012-D-0322-0002>.
Rangan, Urvashi, Ph.D., Michael Crupain, M.D., and Michael Hansen. "Comment from Consumer Reports." Letter. 12 Nov. 2013. Regulations.gov. N.p., 16 Nov. 2013. Web. 28 Nov. 2013. <http://www.regulations.gov/#!documentDetail;D=FDA-2012-D-0322-0016>.
Roberts, Kathleen M. "Comment from Arsenic Science Task Force ASTF." Letter to US FDA. 12 Nov. 2013. Regulations.gov`. N.p., 16 Nov. 2013. Web. 28 Nov. 2013. <http://www.regulations.gov/#!documentDetail;D=FDA-2012-D-0322-0017>.
Seetin, Mark W. "U.S. Apple Association - Comment." Letter to US FDA. 8 Nov. 2013. Regulations.gov. N.p., 3 Dec. 2013. Web. 4 Dec. 2013. <http://www.regulations.gov/#!documentDetail;D=FDA-2012-D-0322-0021>.
Tomaselli, Paige. "RE: Docket No. FDA-2012-D-322; Comments to FDA on Draft Guidance for Industry on Arsenic in Apple Juice: Action Level." Letter to US FDA. 12 Nov. 2013. Centerforfoodsafety.org. Center for Food Safety, 13 Nov. 2013. Web. 2 Dec. 2013. <http://www.centerforfoodsafety.org/files/2013-11-12-comments-on-apple-juice-action-levels--final_61746.pdf>.
United States. Food and Drug Administration. Center for Food Safety and Applied Nutrition. Regulations.gov. N.p., 13 Sept. 2013. Web. 26 Nov. 2013. <http://www.regulations.gov/>.
Vaughan, Patricia M. "American Beverage Association Comment." Letter to US FDA. 25 Oct. 2013. Regulations.gov. N.p., 4 Nov. 2013. Web. 28 Nov. 2013. <http://www.regulations.gov/#!documentDetail;D=FDA-2012-D-0322-0012>.