A recent report from Consumer Reports magazine asserts that many rice products found on grocery store shelves contain arsenic, a potent human carcinogen. The testing of more than 200 samples of rice products, including organic rice baby cereal, rice breakfast cereals, brown rice and white rice, reportedly showed that in virtually every product tested, measureable amounts of total arsenic were found in two forms—inorganic and organic arsenic. Although organic arsenic is not believed to be as harmful, inorganic arsenic is deadly at high doses and has been linked to a variety of cancers, as well as heart disease and other illnesses.

Arsenic has long been recognized as a poison and a contaminant in drinking water, but this recent report adds to growing concerns about arsenic in foods. A January investigation by Consumer Reports previously found arsenic in apple and grape juices, popular items for children. Arsenic can also be found in a variety of other foods including fruits, vegetables and seafood, both imported and U.S.-grown. This newest report implicates a number of popular brand name products, and food manufacturers, distributors and retailers would be well advised to monitor developments closely.

The report recommends that a standard for arsenic should be set for rice and that the U.S. Food and Drug Administration (FDA) should prohibit agricultural practices that may lead to increases in arsenic in rice. At the current time, there is only a federal limit for arsenic in drinking water, set at 10 parts per billion (ppb). In an FDA press release, however, the agency cautioned against “getting ahead of the science” and has stated that further testing needs to be done to determine what steps must be taken to reduce exposure to arsenic. Although the agency released preliminary data on arsenic in rice products that were commensurate with the findings by Consumer Reports, it plans to collect data on 1,200 food samples by the end of the year before making its own recommendations on arsenic intake.

On Friday, September 21, 2012, a House bill was introduced that seeks to cap the amount of arsenic allowed in rice and rice-based products. The “Reducing Food-Based Inorganic and Organic Compounds Exposure Act,” or RICE Act, would set a maximum allowable level of arsenic in rice, though the bill does not actually specify an amount, leaving FDA to determine an appropriate amount. The bill only requires that the agency set a level that is at least as stringent as the current requirements for bottled water (10 parts per billion) and that the number be based on “the maximum achievable reduction in case risk.” FDA would have to establish the arsenic limits within two years after the bill is passed. The RICE Act, introduced by Democratic lawmakers in a bitterly partisan chamber, is likely to face some opposition, particularly with a Republican majority.

Regardless of whether the bill ultimately passes and such limits actually come to fruition, these events raise some interesting issues of relevance to growers, suppliers, manufacturers, shippers and retailers.

Increased FDA Scrutiny of Potential Health Hazards in Food

  • FDA has already stated that the agency has prioritized analyzing arsenic levels in rice and is committed to understanding the extent to which substances such as arsenic are present in foods, what risks they may pose and whether these risks can be minimized, as well as to sharing these findings.
  • Pursuant to the Food Safety Modernization Act (FSMA), FDA is instructed to issue contaminant-specific and science-based guidance documents, including guidance for the setting of action levels. Four major rules implementing FSMA provisions are expected to be released this year, pertaining to preventative controls, produce safety and foreign supplier verification. There may be pressure for FDA to set acceptable limits for specific contaminants. These initiatives should be monitored and opportunities for comment should be considered.
  • FDA has also been under ongoing pressure to clarify specific labeling terms, such as “gluten-free” and “all natural.”
  • These items all point to an evolving legal landscape and new regulatory obligations that further emphasize food safety initiatives.

Increased Scrutiny of Food Supply Chain

  • Imports: These safety concerns will undoubtedly increase the scrutiny of food imported into the U.S. food supply from abroad, potentially causing import issues at the border, with products held up and longer delays before release. They may also lead to problems with food offered for export.
  • Supply Chain: Importers need to manage their supply chains to ensure the safety of imported foods; they are accountable for verifying that the food they import has been produced in accordance with U.S. standards, including those such as arsenic levels that are being studied and developed.
  • Supplier Certifications: Importers and domestic retailers alike should consider requesting a Letter of Guarantee from suppliers consistent with 21 C.F.R. 7.12 and 7.13 in order to receive a good faith guarantee that protects parties from violations under the FDCA.
  • Supplier Audits: In order to ensure that suppliers are in compliance with FDA food safety standards, importers and domestic retailers should “know who they are buying from” and inspect food suppliers, either by their own auditors or by external auditors.

Product Liability Lawsuits

  • Lawsuits in the food industry are on the rise, with claims that products are, or could be, harmful; that they are misleading; and that their marketing is an unfair deceptive practice.
  • Even in the absence of federal regulatory standards, product liability lawsuits are still possible and have been trending upwards.
  • Beyond the time and costs associated with litigation is the risk that consumer confidence will be eroded.