American Bakers Association Prop 65 Technical Guide Prepared by: Covington & Burling and Quality Assurance Strategies, LLC August 2018 This technical document contains the following documents that may be useful in understanding and assessing your company’s obligations under California’s Safe Drinking Water and Toxic Enforcement Act of 1986, otherwise known as Proposition 65 (Prop 65): 1. Covington Prop 65 White Paper 2. Quality Assurance Strategies, LLC’s Prop 65 Technical Document: Technical Considerations and FSMA Food Safety Strategy 3. Exponent’s Consumption Intake Study 4. Covington Memo on Recent State, Judicial, and Federal Activities on Prop 65 This Prop 65 technical guide and its individual documents are for informational purposes only, is not intended to convey or constitute legal advice, and is not a substitute for obtaining legal advice from a qualified attorney. Please contact your attorney to obtain advice with respect to any particular issue or problem. American Bakers Association Quality Assurance Strategies, LLC’s Prop 65 Technical Document: Technical Considerations and FSMA Food Safety Strategies I. Introduction A. ABA’s Prop 65 Working Group This document reflects the discussions of ABA’s Prop 65 Working Group and is intended to be a resource for bakers by providing the most up to date information on key Prop 65 listed chemicals particularly relevant to bakery products, along with easy- to-implement food safety strategies for assessing and mitigating potential Prop 65 obligations. This document includes suggestions from a variety of resources, including from the European Union (EU) because the science in the EU appears, for some Prop 65 listed chemicals, to be more advanced with respect to lowering the levels of such chemicals in food. Other regulatory authorities, including the FDA, appear to be incorporating ideas from these EU references in their own reduction strategies, which appear to be consistent with current industry best practices. As new information becomes available that is relevant to this Technical Document, ABA will amend this Prop 65 Technical Document. B. Priority Prop 65 Listed Chemicals relevant to Bakers and the Food Industry ABA’s Prop 65 Working Group reviewed the more than 900 plus chemicals listed under Prop 65 to assess which of the listed chemicals are most likely to be relevant to bakery products. A chemical may be listed under Prop 65 as a carcinogen, a reproductive toxicant, or both. Out of the currently 900+ chemicals listed under Prop 65, ABA’s Prop 65 Working Group identified eight Prop 65 listed chemicals as “priority chemicals” because of their relevance to bakery products. Even so, these eight “priority chemicals” listed under Prop 65 should not be viewed as an exclusive exhaustive list because the listing and de-listing of Prop 65 chemicals is a continuous process and other chemicals relevant to bakery products may be listed under Prop 65 in the future. Consequently, industry best practice for bakers includes continuously monitoring Prop 65’s chemical list along with the company’s product portfolio for historical or documented cases of potential hazards related to chemicals or toxins. The eight Prop 65 listed “priority chemicals” relevant to bakers are as follows (the last four can be classified collectively as Heavy Metals): • Acrylamide • Furfuryl Alcohol 2 American Bakers Association • 4-MEI • Glyphosate • Lead • Cadmium • Arsenic • Mercury This document includes a discussion of only the top four “priority chemicals”-- glyphosate, furfuryl alcohol, 4-MEI, and acrylamide. We include the four heavy metals on the list of “priority chemicals” to make bakers aware that they may want to include an assessment of these (and potentially other) heavy metals as part of their food safety strategies. FDA has formed a working group to examine the heavy metals that may pose higher risk to children. The information provided by FDA from this working group may become relevant and/or useful to bakers after FDA releases its conclusions and/or data.1 C. Using FSMA’s Preventive Controls Strategy to Assess and Mitigate Potential Prop 65 Obligations The regulations implementing the U.S. Food Safety Modernization Act (FSMA) require non-exempt food manufacturers to have a Food Safety Plan that includes, among other things, a hazard analysis and, where applicable, preventive controls. As discussed below in Section III, in developing Food Safety Plans, food manufacturers must review potential hazards for the end use target audience or consumers. Consequently, state or other regulations (e.g., foreign countries, provincial, Prop 65, etc.) may impact a company’s hazard analysis and preventive controls, depending on where that company does business. For example, if a company is shipping ready to eat (RTE) food products to hospitals targeting immune compromised consumers, foods for toddlers or babies where lead or cadmium are strictly regulated, or to countries where allergen threshold levels are specified, FSMA requires, and industry best practice is to use, the hazard analysis to assess risks associated with these circumstances and/or specific populations and to implement preventive controls to prevent/mitigate risks to such populations. As a best practice under FSMA and under Prop 65, bakers could build into their Food Safety Plans an assessment of potential hazards associated with the eight Prop 65 “priority chemicals” identified in this document (or other Prop 65 listed chemicals, if 1 https://www.fda.gov/food/foodborneillnesscontaminants/metals/ucm604173.htm 3 American Bakers Association applicable) and implement, if needed, preventive controls or other strategies, such as supply chain programs, to mitigate potential exposures under Prop 65. The remainder of this document is comprised of three main sections: (1) a discussion of the top four Prop 65 listed “priority chemicals” relevant to bakery products; (2) a discussion of technical considerations and food safety strategies for assessing and complying with Prop 65 obligations; and (3) how to calculate exposures to Prop 65 listed chemicals in micrograms/day from lab results that are provided in parts per million (ppm) or parts per billion (ppb). II. The Top Four Priority Prop 65 Listed Chemicals for Bakery Products and Possible Reduction Strategies2 This section discusses the top four priority Prop 65 listed chemicals that appear to be the most relevant to bakery products. Under Prop 65, a consumer product (including food) sold in California is required to be accompanied by a “clear and reasonable” warning if the product exposes a consumer to levels of a listed chemical that is above “safe harbor” levels. (For additional information on Prop 65 safe harbor levels and the Prop 65 safe harbor warning requirements, please see ABA’s Prop 65 White Paper from Covington.) Chemicals are listed under Prop 65 as carcinogens, reproductive toxicants, or both. For chemicals listed as carcinogens, the safe harbor levels are described as “No Significant Risk Levels” (NSRL). For chemicals listed as reproductive toxicants, the safe harbor levels are described as “Maximum Allowable Dose Levels” (MADL). A “safe harbor” level may be established by California’s Office of Environmental Health Hazard Assessment (OEHHA) or by others (including companies). Of the 900+ Prop 65 listed chemicals, OEHHA has established a NSRL and/or MADL “safe harbor level” for only 300+ of the listed chemicals. After a chemical is listed under Prop 65, there is a year “grace period” during which a warning is not required. In other words, the Prop 65 warning requirement becomes operative a year after the date on which the chemical is listed, giving companies time to comply with the warning requirement. The following top four “priority chemicals” are listed in descending order of when the listing became operative under Prop 65, starting with the most recent. A. Glyphosate • Glyphosate is an herbicide (aka Round Up) widely applied to agricultural products including, but not limited to, corn, wheat, oats, and soybeans. 2 OEHHA Prop 65 NSRL/MADL’s; https://oehha.ca.gov/media/downloads/proposition-65/general-info/safeharborlist05162017.pdf 4 American Bakers Association • Glyphosate is listed under Prop 65 as a carcinogen. • The listing of glyphosate became operative July 7, 2018. • Currently, there are at least 750 products that are registered for sale in the U.S. that contain glyphosate. • NSRL: 1100 µg/day (effective July 1, 2018). • MADL: Not Applicable (glyphosate is not listed under Prop 65 as a reproductive toxicant). The EU and FDA have provided techniques and recommendations for reducing glyphosate levels in food, including limiting the use of the herbicide as a desiccant before harvesting. Plaintiffs have filed product liability lawsuits on glyphosate’s safety alleging physical harm such as cancer. These lawsuits are in addition to consumer deception lawsuits filed by consumers alleging that “natural” claims are deceptive on products that contain residual levels of glyphosate. (For additional information on these lawsuits, please see ABA’s 2018 Legal Memorandum on Recent Prop 65 Activities from Covington.) B. Furfuryl Alcohol (FFA) • FFA is produced from furan formation during the Maillard reaction, which is a reaction that occurs in foods between reducing sugars and amino acids, typically during baking, frying, or roasting of foods containing carbohydrates. • FFA is listed under Prop 65 as a carcinogen. • The listing of FFA became operative September 30, 2017, which was the date