{"id":8542,"date":"2019-02-25T16:20:57","date_gmt":"2019-02-25T21:20:57","guid":{"rendered":"http:\/\/blogs.edf.org\/health\/?p=8542"},"modified":"2019-12-04T13:48:16","modified_gmt":"2019-12-04T18:48:16","slug":"fda-seeks-expert-panel-review-inorganic-arsenic-food","status":"publish","type":"post","link":"https:\/\/blogs.edf.org\/health\/2019\/02\/25\/fda-seeks-expert-panel-review-inorganic-arsenic-food\/","title":{"rendered":"FDA seeks expert panel review of neurodevelopmental risk of inorganic arsenic in food"},"content":{"rendered":"

Tom Neltner, J.D.<\/a><\/em>,\u00a0<\/em>is Chemicals Policy Director and\u00a0Maricel Maffini, Ph.D.,<\/em>\u00a0Consultant<\/p>\n

Updated March 27, 2019 to include a link to EDF’s comments<\/a> and to Project TENDR’s comments<\/a>.<\/em><\/p>\n

The United States has asked the Codex Alimentarius<\/a> (Codex), the international standard setting body for food, to prioritize inorganic arsenic for evaluation of non-cancer effects<\/a> such as neurodevelopmental, immunological, and cardiovascular effects. The evaluation would be conducted by an expert panel convened by the Joint Food and Agriculture Organization \/ World Health Organization Expert Committee on Food Additives<\/a> (JECFA), on which Codex relies for scientific advice.[1]<\/a><\/p>\n

EDF will submit comments in support of the proposal and encourages others to do the same.[2]<\/a> However, FDA should not wait for the review to be finished before incorporating this evidence into its long-awaited standards<\/a> for inorganic arsenic in rice.<\/p>\n

Evidence of harm from inorganic arsenic on children\u2019s neurodevelopment has grown more compelling<\/strong><\/p>\n

Inorganic arsenic is a known water and food contaminant. FDA has measured it in many foods included in its Total Diet Study<\/a>, but it\u2019s mostly known for its presence in baby and infant foods such as rice<\/a> and fruit juices<\/a>. The presence of inorganic arsenic in staples of children\u2019s diets<\/a> is concerning due to its risk of potential lasting health effects. The risks posed by inorganic arsenic on fetal and child brain development has become increasingly clear since the early 2000s as epidemiological studies began to scrutinize more subtle effects such as learning disorders and epigenetic effects. Earlier studies mostly focused on gross measures such as low body weight or increased stillbirths.<\/p>\n

<\/p>\n

In 2013, David Bellinger<\/a> authored a review of the evidence on children\u2019s neurodevelopment, concluding that, \u201cThe pace of research on the developmental neurotoxicity of arsenic is increasing, with the current evidence providing few firm conclusions but ample reason to be concerned about the neurodevelopmental impact of this chemical.\u201d However, the review said \u201cat present, the epidemiological data do not permit firm conclusions to be drawn regarding these issues,\u201d and suggested that consistent measurements of exposure and of a core set of endpoints would allow firmer conclusions.<\/p>\n

Three years later, FDA released a risk assessment for inorganic arsenic<\/a> in rice and rice products and proposed a draft limit for the substance in rice based on the cancer risk. However, tucked in the last pages of the risk assessment is an updated literature search for non-cancer endpoints conducted by the agency\u2019s scientists. Even though they stated that the search was not exhaustive, it allowed them to conclude that the \u201cstudies support our conclusion that exposure to inorganic arsenic either in utero<\/em> or in early childhood has adverse effects on neurobehavioral development.\u201d \u00a0The agency acknowledged that, like low level exposure to lead and mercury, the harm from inorganic arsenic may be \u201cmanifested in intelligence test results in children<\/a>.\u201d However, the evidence was not yet sufficient to develop a dose-response relationship necessary to quantify the harm and societal cost.<\/p>\n

In 2017, in a study commissioned by Healthy Babies Bright Futures<\/a>, Abt Associates<\/a> updated the literature search for inorganic arsenic effects on neurodevelopment and proposed a dose-response model that estimated IQ loss associated with increased inorganic arsenic exposure. Abt \u201cconcluded that, while there are uncertainties, it is feasible to draw upon the relationships from the peer-reviewed literature to quantify and monetize IQ loss associated with exposures to [inorganic] arsenic from infant rice cereal, rice, and other rice products.\u201d Based on this relationship it estimated that, \u201cIn the U.S. population of children aged 0-6 [years], replacing all rice and rice products with alternate foods containing no arsenic would result in additional annual earnings of approximately $12 to $18 billion by avoiding losses of more than 9 million IQ points per year.\u201d<\/p>\n

FDA is conducting additional studies on neurodevelopmental effects<\/strong><\/p>\n

FDA\u2019s National Center for Toxicological Research is also studying the effects of in utero<\/em> inorganic arsenic exposure in rats. Last month, it published results of a study<\/a> showing a direct relationship between ingestion of the substance and the concentration found in the pup\u2019s brains. The researchers saw motor function development delay and delays in other developmental milestones such as bilateral eye opening and incisor eruption, concluding that these effects \u201cmay indicate thyroid alterations, as endocrine disruption of thyroid hormones\u201d are associated with delays in eye opening and tooth eruption in both rats and humans.<\/p>\n

Using a nematode model<\/a>, scientists at FDA\u2019s Office of Applied Research and Safety Assessment have also shown that, as in humans and rodents, arsenic causes developmental hyperactivity in the nematodes, as well as marked growth delay as the doses increased.<\/p>\n

Recognizing that heavy metals often occur in food in combination, FDA has established a Toxic Elements Work Group<\/a> to prioritize efforts in this area. The Work Group charged agency scientists with assessing cumulative effects of lead, cadmium, mercury and inorganic arsenic on children\u2019s neurological development. The analysis will enable the agency to prioritize setting limits for specific foods that significantly contribute to exposure and developing preventive controls and best practices to reduce that exposure.<\/p>\n

Conclusion<\/strong><\/p>\n

We applaud FDA for seeking expert review by JECFA evaluation of the non-cancer effects of inorganic arsenic while continuing its research and analysis. Rather than wait for JECFA to complete the review, we encourage FDA to build on the dose response model developed by Abt Associates and incorporate this evidence into its long-awaited standards<\/a> for inorganic arsenic in rice.<\/p>\n

[1]<\/a> In 2011, JECFA withdrew<\/a> its inorganic arsenic provisional tolerable weekly intake limit of 15 micrograms per kg-bw per day because it was no longer sufficient to protect public health. That limit was based on the cancer effects.<\/p>\n

[2]<\/a> Comments are must be sent before March 27, 2019 to U.S. Department of Agriculture\u2019s Doreen Chen-Moulec at doreen.chenmoulec@osec.usda.gov<\/a>.\u00a0 The USDA coordinates the\u00a0U.S. delegation to Codex<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"

Tom Neltner, J.D.,\u00a0is Chemicals Policy Director and\u00a0Maricel Maffini, Ph.D.,\u00a0Consultant Updated March 27, 2019 to include a link to EDF’s comments and to Project TENDR’s comments. The United States has asked the Codex Alimentarius (Codex), the international standard setting body for food, to prioritize inorganic arsenic for evaluation of non-cancer effects such as neurodevelopmental, immunological, and …<\/p>\n","protected":false},"author":69548,"featured_media":8543,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[69,114082,44,39263,56096],"tags":[39182,106770,91633,107191],"coauthors":[114044],"class_list":["post-8542","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-fda","category-food","category-policy","category-public-health","category-omboira","tag-arsenic","tag-codex","tag-fda","tag-heavy-metals-in-food"],"acf":[],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/posts\/8542","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/users\/69548"}],"replies":[{"embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/comments?post=8542"}],"version-history":[{"count":0,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/posts\/8542\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/media\/8543"}],"wp:attachment":[{"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/media?parent=8542"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/categories?post=8542"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/tags?post=8542"},{"taxonomy":"author","embeddable":true,"href":"https:\/\/blogs.edf.org\/health\/wp-json\/wp\/v2\/coauthors?post=8542"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}