FOR INTERNAL USE ONLY FINAL – UPDATED 7/9/2013 ROLLOUT ACTION PLAN: Arsenic in Apple Juice Risk Assessment Target Date: Friday, July 12, 2013 I. ROLLOUT BRIEF Background: It has long been known that arsenic can be found in drinking water and foods associated with water and soil such as seafood, grains, vegetables, and fruit juices. FDA has completed its work on arsenic in apple juice and is ready to announce a draft action level of 10 parts per billion for inorganic arsenic. Based on our data and analytical work, FDA can confirm that the overall consumption of apple juice by children and adults in this country does not pose a safety concern. Arsenic in apple juice. In late 2011, Food and Water Watch and Dr. Oz generated strong public interest regarding arsenic in apple juice and the need for FDA to set limits for inorganic arsenic. FDA’s data indicated that total arsenic levels in apple juice have remained relatively low for many years and our scientists were more focused on arsenic levels in rice and rice products. However, we determined that it was appropriate to conduct additional testing, undertake a quantitative risk assessment, and ultimately to set an action level to help keep out of the food supply even the occasional lot of apple juice that exceeds this threshold. FDA engaged in extensive consultation with EPA on the risk assessment and, in addition to review by its own scientists, obtained peer review by scientists from EPA, NIH and CDC. Considering the results of the risk assessment, FDA has proposed a draft action level for inorganic arsenic in apple juice of 10 micrograms/kilogram or 10 parts per billion (ppb). Ten ppb is in line with EPA’s level of 10 ppb arsenic in drinking water, which is consumed in much greater quantities than apple juice. The draft guidance, which will be open for public comment, along with the quantitative risk assessment and a supporting background document, are in review at OMB. Arsenic in rice and rice products. In September 2012, we posted the first set of data on arsenic in rice and committed publicly to publish the complete data set around the end of 2012. We are planning to announce the results soon, and to identify the next steps we will undertake, including conducting one or more risk assessments (working with EPA); coordinating with USDA, industry, and others on mitigation strategies; developing and providing consumer advice, and possible action levels. Spokespeople: Margaret Hamburg/Mike Taylor Technical Experts: Suzanne Fitzpatrick, Toxicologist, CFSAN and possibly Don Zink, Senior Scientist, CFSAN Third Party Stakeholders: Efforts will be made for the following individuals/organizations to to speak supportively of FDA’s announcement. Dr. Jerome Paulson, chairperson of the American Academy of Pediatrics’ Council on Environmental Health; Possibly Linda Birnbaum, NIEHS. Communications Strategy: A targeted communications approach is intended to set the tone of the story from the outset by providing key reporters with materials and interviews under embargo a day or two in advance. The approach also involves outreach to select stakeholders in advance – American Academy of Pediatrics, Consumer Reports and GMA. 1 2014-3702-OEA-010039 FOR INTERNAL USE ONLY FINAL – UPDATED 7/9/2013 Outreach will signal that FDA has addressed arsenic in apple juice and the results on arsenic in rice are coming. Our goal is to have a broader communications effort in announcing our actions with regard to arsenic in rice. In lieu of a formal media call, we will conduct embargoed interviews in advance with Richard Besser of ABC News, Elizabeth Weise of USA Today, Mary Clare Jalonick of AP, and Sabrina Tavernise of The New York Times. The interviews will be held jointly with Commissioner Hamburg and Mike Taylor. The embargo time will be set for midnight the morning before materials post. This will allow for stories to run in papers and on broadcast the morning of posting. These interviews will be held under strict conditions to honor the embargo and only reach to third parties that FDA has briefed. In addition, Mike Taylor will handle interviews with key reporters including Brady Dennis of The Washington Post, Monica Eng of the Chicago Tribune, Tom Burton of the The Wall Street Journal and Helena Bottemiller of Food Safety News. These interviews will be planned for early on the morning of posting. Key elements will include issuance of a press release, posting materials to our Arsenic in Apple Juice landing page, an FDA Voice blog, and Consumer Update. As stated earlier, we will hold briefings in advance with the American Academy of Pediatrics, Consumer Reports, GMA, USDA FNS, and NIEHS. Heads-up calls will be made to the Juice Products Association, Food and Water Watch, FMI, Marion Nestle, and the Illinois Attorney General. Materials 1. Risk assessment and peer review 2. Draft Guidance and supporting documentation 3. FR Notice 4. Press release 5. Key messages / responsive Q&A 6. Consumer Update 7. Blog Web/Social Media 1. Update our Web Page: The current Arsenic in Apple Juice page will be modified to include information about the proposal to institute an action level of 10 ppb for arsenic in apple juice. The current links on the page will be moved down to the Additional Information box, and new links to the new Consumer Update and Press Release will appear instead. The Questions and Answers: Apple Juice and Arsenic will be revised to include information about the draft guidance and action level, and this link will be moved up with the CU and PR. 2. Feature on FDA.Gov home page 3. Post Consumer Update to Facebook 4. Tweet the press release and blog Stakeholder, Congressional, International, and Govt Agency Outreach 1. Coordinate once plan is approved with EPA, CDC, USDA, and NIEHS so they will be prepared with their own responses to questions and possibly provide statements. 2 2014-3702-OEA-010040 FOR INTERNAL USE ONLY FINAL – UPDATED 7/9/2013 2. Brief in advance Dr. Richard Besser, Consumer Reports and American Academy of Pediatrics on the risk assessment on how FDA conducted the assessment, factors it considered in the risk management, explain the peer review process undertaken and respond to questions to demonstrate the rigor of the scientific analysis. (Do not share the actual action level.). Reach out to Illinois AG’s office. 3. Broad outreach to stakeholders – including medical professionals and Safe Food Coalition, Federal Agencies, Congress, state partners, and international parties through dissemination of materials via list-servs. Timeline Monday, July 8 3-3:45 pm Prep w/ Commissioner and Mike Taylor Tuesday, July 9 FR notice submitted Wednesday, July 10 3:00 - 4:30 pm COB Embargoed interviews Brief other federal agencies (EPA, CDC, NIEHS, USDA FNS) Thursday, July 11 am 2:00 - 3:00 pm COB Friday, July 12 7:00 am Brief Consumer Reports, GMA, and AAP Embargoed interviews Limited outreach to Hill Embargoed heads-up call to stakeholders just to indicate that we will be announcing on Friday - Juice Products Assn, Rice Federation, Food & Water Watch Materials post to web o Web page updated (risk assessment, peer review of the assessment, draft guidance, and supporting documentation) o Press Release o Consumer Update o Blog Social Media – Twitter and Facebook 7:30-9:00 am Follow up interviews w Mike Taylor 8:45 am FR Notice posts Update web w link to FR 10:30-11:30 am Follow up interviews w Mike Taylor 3 2014-3702-OEA-010041