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

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• 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

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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

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• 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 on which products exposing consumers to FFA were required to include a Prop 65 warning. • FFA is listed under Prop 65 as a carcinogen based on exposure through inhalation, not ingestion. • NSRL: Not Established. • MADL: Not Applicable (FFA is not listed under Prop 65 as a reproductive toxicant). ABA’s Prop 65 Working Group is currently evaluating and assessing FFA- relevant consumption studies and test methods. Thus far, it does not appear that there is a reproducible, validated test method for detecting and quantifying FFA in all food matrices. Bakers who engage in laboratory testing may want to confirm that the test method used by the lab is an AOAC approved method (e.g., is identified in Official Methods of Analysis of AOAC International) and that the test results, including quantitative data, are repeatable. As a general matter, in litigation, the litigants often

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challenge test methods and test results, so a robust, valid method is key in assessing accurate FFA levels in food.

Additionally, based on preliminary information, FFA appears to share similarities with acrylamide with respect to its chemical formation. ABA’s Prop 65 Working Group is currently reviewing available FFA publications and coalition studies and is working on a unified approach to fast-track actions and learnings.

C. 4-Methylimidazole (4-MEI) • 4-MEI is a by-product of the Maillard reaction (see description above for FFA). • 4-MEI is listed under Prop 65 as a carcinogen. • The listing of 4-MEI became operative on January 7, 2012. • 4-MEI appears to be present in Class III and Class IV caramel colors in higher levels apparently due to containing ammonia or ammonia salts • NSRL: 29 µg/day. • MADL: Not Applicable (4-MEI is not listed under Prop 65 as a reproductive toxicant). A simple 4-MEI reduction strategy would be to eliminate Class III and IV caramel colors from a company’s ingredient portfolio. Doing so, however, may affect cost, product performance, and organoleptic factors.

D. Acrylamide

• Acrylamide is a by-product of the Maillard reaction (see description above for FFA). • 4 MEI is listed under Prop 65 as both a carcinogen and a reproductive toxicant. • The listing of acrylamide as a carcinogen became operative in 1991. The listing of acrylamide as a reproductive toxicant because operative in February of 2012. • Acrylamide has been targeted in numerous Prop 65 lawsuits against food companies, including bakery companies. • NSRL: 0.2 µg/day. • MADL: 140 µg/day. Acrylamide is formed in food by a reaction between asparagine and reducing sugars as part of the Maillard Reaction under conditions of high temperatures (> 120°C) and low moisture, which occurs in both industrial processes and home-prepared food. Acrylamide is also naturally occurring in a variety of foods and beverages. Because

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acrylamide forms as a result of cooking select foods in certain ways (e.g., baking, frying), it has likely been present in various foods for centuries.

In addition to the strategies discussed below, it may be prudent for some businesses to understand levels of acrylamide in existing products so that such businesses can assess potential implications and whether there is a need to take actions or explore options to reduce acrylamide levels in accordance with the As Low As Reasonably Achievable (ALARA) concept.3 In addition, businesses can explore other potentially helpful acrylamide-reduction strategies such as using product category- specific “Action Levels” as criteria for product design, product development, and formulation/process changes, and developing and using a database and documents to support the business’s approach and position on acrylamide levels in its products, which database could be useful in the event of a Prop 65 challenge.

1. New European Regulation on Acrylamide Reduction4

European countries have long been assertive and pro-active with acrylamide reduction strategies in food products. Effective April 11, 2018, the EU now requires manufacturers to show progress against its benchmarked values. Companies exporting to Europe may be required to comply with these new requirements. The food categories affected by the EU’s new requirements include:

• Potato products • Bread • Baked goods • Cereals • Fine bakery goods • Biscuits/cookies • Cereal bars • Coffee • Baby foods The following are highlights of the new EU acrylamide reduction requirements:

3 ALARA - As Low as Reasonably Achievable- Principle - Requires appropriate measures to reduce the presence of chemical in products to a minimum base on what is realistic and reasonable in commercial practice. 4 https://ec.europa.eu/food/sites/food/files/safety/docs/cs_contaminants_catalogue_acrylamide_recommendation_10012011_food_en .pdf

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• Covered food products must show lower acrylamide levels than benchmarks and must reflect the ALARA Principle. • An affected business must provide product-specific acrylamide data to be assessed, including how likely it is that the business will exceed the required benchmarks. • Businesses were required to implement mitigation strategies immediately upon issuance of the new EU requirement. a) EU Acrylamide Reduction Strategies

The following section highlights some key strategies developed in the EU that might assist companies who are looking to reduce potential acrylamide levels in food products. In addition to the strategies identified below, there are several general strategies that appear well-known in being useful to achieve appreciable reductions in acrylamide levels, including enzymes or other ingredients that are effective in reducing acrylamide, as well as adjustments to time and temperature of heat treatment.

b) EFSI Toolkit

In 2014, the EU Specialty Food Ingredients (EFSI), formerly Food Drink Europe (FDE) published a Toolkit that is still widely used today for its acrylamide reduction strategies. FDA also has guidance on acrylamide reduction strategies,5 but its guidance is primarily focused on potato chips and flakes, with only a few references to grain products, which are similar to the EFSI Toolkit recommendations. FDA, WHO (World Health Organization), and other global agencies have embraced the EFSI Toolkit. The EFSI Toolkit is a recognized best practice resource that may be helpful for companies seeking to understand options and strategies for reducing acrylamide in food products.

As illustrated in Figure 1 below, the EFSI Toolkit groups 14 potential acrylamide reduction strategies under four broad categories. Notably, there is no single effective strategy or group of strategies that is guaranteed to result in consistent acrylamide reductions, because every food product, crop, and manufacturing process may respond differently to the strategy/group of strategies. For example, there have been instances where identical manufacturing lines producing the same product formula have had varying results in acrylamide reduction.

5 Guidance for Industry Acrylamide in Foods; https://www.fda.gov/downloads/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ChemicalContaminantsMetal sNaturalToxinsPesticides/UCM374534.pdf

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Figure 1: EFSI Toolkit on Acrylamide Reduction Strategies6

• Agronomical Effects on Acrylamide Levels

o Asparagine (an amino acid) is the critical component that leads to the acrylamide formation in grain products. Higher free asparagine levels appear to result in higher acrylamide levels.

o Free asparagine within and between grain types varies widely. o Most free asparagine is found in the bran, which may mean that whole grain products may be more likely to contain more acrylamide than the same products produced with wheat flour endosperm that does not contain bran. • Modifications to Product Recipes May Lower Acrylamide Levels

o Raising agents. Reducing or replacing ammonium bicarbonate (NH4HCO3) in recipes may result in reducing acrylamide levels, but doing so may negatively affect the organoleptic properties of the food.

o Sugars. Replacing fructose with glucose or saccharose appears to be very effective in reducing acrylamide formation, particularly in recipes containing ammonium bicarbonate.

o pH. Lowering the pH appears to reduce acrylamide levels. • Rework. Reworking certain bakery products may increase the amount of acrylamide in the final product due to reformulation, further re-processing, or re-baking.

6 Divalent cations are chemical bonds

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• Processing Activities and Other Considerations that May Affect Acrylamide Levels o Fermentation. Fermentation of dough may result in lower levels of acrylamide in the final product. . Long yeast fermentations appear to be an effective way to reduce asparagine levels, thereby reducing acrylamide levels.

o Dough aging. In some dough, more acrylamide is formed when the dough is allowed to age (e.g., 35% increase of acrylamide over three hours) due to the increase in free asparagine in dough over time.

o Thermal input and moisture control. The formation of acrylamide during the baking of grain-based products is closely related to the combination of moisture content and baking time and temperature (thermal input). Products baked to the same moisture, but with less color may result in lower acrylamide levels even though longer baking times would be required. Products baked at a high temperature and to a low final moisture content tend to have higher acrylamide levels.

o Asparaginase. Using asparaginase in food processing appears to have a high potential for reducing acrylamide levels by reducing free asparagine levels, especially in high moisture, neutral pH systems at elevated temperatures

o Color and moisture content. Grain-based products that are lighter in color or that are subject to less thermal input (e.g., less baked), without increasing the moisture content, may have lower acrylamide levels. III. The FSMA Food Safety Plan/HACCP Strategy for Understanding and Complying with Prop 65 Obligations

As companies consider how to approach potential obligations under California’s Proposition 65, one efficient approach could be to follow FDA’s preventive control principles provided under FSMA. For example, it may save on company resources if the company includes an assessment of Prop 65 listed chemicals in its hazard analysis (if any Prop 65 listed chemical presented a reasonable and foreseeable food safety risk) and manages any such potential risks in a Food Safety Plan. Further, a company that identifies a Prop 65 listed chemical in a product provided by a supplier could manage such hazards in its FSMA Supply Chain Program, and may be required to do so if the company is relying on its supplier to prevent or mitigate the level of the Prop 65 listed chemical in the supplied product.

A. FSMA Supply Chain Program and Foreign Supplier Verification Program (FSVP)

FSMA’s Supply Chain Program and FSVP require a company who relies on a supplier to control a potential hazard to ensure that such suppliers (and all raw

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materials, ingredients, and packaging materials from such suppliers) are qualified and approved. FSMA’s Supply Chain Program and FSVP also require companies to verify, e.g., through on-site audits, product testing, or other appropriate activities, that such suppliers are controlling/preventing any supply-chain applied controls hazards. Using a robust FSMA Supply Chain Program and/or FSVP to manage Prop 65 obligations should be an efficient and effective approach to not only eliminate/mitigate potential Prop 65 listed chemicals in a company’s food products, but is intended to ensure product formulae wholesomeness and mitigate other food safety hazards.

A robust FSMA Supply Chain Program and/or FSVP must include the following key activities, which could be highly relevant in managing a company’s potential Prop 65 obligations: (1) understanding the hazards in the supplier’s food, including from packaging; (2) qualifying and approving suppliers who are controlling hazards the company is relying on for food safety; (3) determining, conducting, and documenting supplier verifications activities and the frequency of such activities, (4) implementing corrective actions, where applicable; and (5) re-assessing a supplier’s qualifications for cause or on a regular basis.

Based on these key FSMA supplier-related activities, companies could incorporate the following three activities directly related to managing Prop 65 listed chemicals:

• Hazard Analysis • Supplier Qualification and Approval Process

o Supplier Verification Activities o Supplier Raw Material Testing Program • Material Monitoring Program (MMP) 1. FSMA Hazard Analysis

Under both FSMA’s domestic Supply Chain Program (as part of its compliance with FSMA’s preventive controls requirements in 21 CFR 117) and FSVP, a company must understand the potential hazards in the food by conducting a hazard analysis. This initial step--the hazard analysis--could incorporate an assessment of known and reasonably foreseeable food safety hazards linked to Prop 65 listed chemicals.

To assess Prop 65 listed chemicals that could be potential food safety hazards in a company’s food, the company could monitor the Prop 65 chemical list, receive updates from its trade associations, follow food industry safety alerts or recalls, and stay up-to-date by reading relevant trade press publications.

2. FSMA Supplier Qualification and Approval Process

There is an expectation that our industry suppliers are our partners, have high food safety and quality standards, an effective traceability program, and are in

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compliance with all regulatory requirements. FSMA now requires this, but a company who relies on suppliers to provide it the necessary food safety information may not obtain the level of transparency it desires from its suppliers, despite the presumption in FSMA’s supply chain programs (both domestic and foreign) that suppliers will comply such customer requests.

For any hazards identified by a company in its hazard analysis that the company is relying on a supplier to control (including Prop 65 listed chemicals), FSMA requires companies to know and understand their supplier’s food safety qualifications and capabilities prior to approving those suppliers and relying on those suppliers to control such hazards.

To assess the qualifications of a supplier, FSMA requires a company to evaluate and assess the supplier’s food safety practices and procedures, its compliance with applicable food safety laws, and its food safety performance history. Obtaining the appropriate documentation on these supplier activities is key to assessing any potential food safety gaps and identifying any potential risks posed by a supplier, including a supplier’s ability to control the supply-chain applied control(s) such as the presence or levels of Prop 65 listed chemicals upon which the company is relying, prior to approval. Generally, there is a manufacturer specific detailed questionnaire or electronic third party or private company software portal process that covers the needed documentation items.

Although not directly related to supplier qualification, one strategy in working with suppliers that a company is relying on to mitigate/prevent the presence of Prop 65 listed chemicals is to include specific requirements in supplier contracts or in product specifications. For example, if a supplier’s product is potentially a source of acrylamide, the supplier contract could require the supplier to incorporate some of the mitigation strategies provided in the EFSI toolkit, as applicable. Further, and consistent with current industry practice, a company could require supplier documentation to include test results demonstrating compliance with the company’s specifications for the absence of/limits on Prop 65 listed chemicals.

3. FSMA Supplier Verification Activities

After approving a supplier under either FSMA’s domestic or foreign supply chain program, a company must determine and conduct verification activities to ensure that the supplier is controlling the hazards upon which the company is relying. If the supplier is preventing/mitigating the levels of Prop 65 listed chemicals, the company’s verification activities of that supplier could include assessing this aspect of the supplier’s performance. A company’s supplier verification activities could include on-site or third- party audits conducted by qualified auditors, product/raw material sampling and testing (which may be relevant, as explained above, to ensure the absence/safe levels of Prop 65 listed chemicals), review of food safety history and food safety compliance records, or other appropriate verification activities, depending on risks and the hazards controlled by the supplier.

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Particularly relevant to assessing a supplier’s ability to prevent/mitigate the levels of Prop 65 listed chemicals are two related programs that a company could incorporate as verification activities a raw material testing program and/or a material monitoring program.

a) Supplier Raw Material Testing Program

A risk-based Raw Material Testing Program should be designed as appropriate for a company’s product portfolio. Potential food safety risks and the presence of Prop 65 listed chemicals may be based on many factors, such as the history of the ingredient, the country of origin, recall activities, published science literature review, company performance standards, sensitivity of the material, known contaminants, regulatory standards or specifications (including Prop 65 Safe Harbor Limits where available), and use of the ingredient in manufacturing (e.g. post-lethality step application such as toppings).

Note that if a company uses a centralized regulatory or quality group to qualify raw materials and other ingredients and components, the company should coordinate and align company testing requirements across the company to prevent mishaps (recalls) and minimize costs. Testing on split lots at multiple facilities should be simplified for supplier compliance programs.

b) Material Monitoring Program (MMP)

Implementing a Material Monitoring Program (MMP) is another approach a company could take as a supplier verification activity, which may be an effective means for verifying that a supplier who is responsible for preventing/mitigating the level of a Prop 65 listed chemical is performing effectively. MMP is primarily focused on a company’s assessment for potential toxins, pesticides, or contaminants in incoming materials. The potential presence of such chemicals in incoming materials makes it essential today to engage in appropriate supplier monitoring programs. Through an MMP, a company evaluates compliance of a supplier’s ingredients to the company’s specifications to ensure, among other things, wholesomeness of food products, compliance to regulations, and validation against adulteration or food fraud. Because of its focus on chemical contaminants, an MMP can be an effective means for monitoring and mitigating Prop 65 listed chemicals.

MMP data can be used for ingredient material risk management as part of a FSMA Food Safety Plan. Additionally, with data generated, it can influence ingredient sourcing/selection options. Selected materials and test parameters are based on data collected, industry intelligence, Country of Origin (COO), emerging issues, shared industry transportation vessels, new or existing Prop 65 Chemical Listing, among other factors.

A sampling plan under an MMP should initially focus on high risk ingredients, with a limited frequency rotation through the high-risk ingredients through the materials

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portfolio until baseline established and potential risks managed. (Table 1 includes a list of ingredients that are known to be high-risk ingredients based on industry history, alerts, recalls, COO, among other things.) Price of entry on all new ingredients for approval should include MMP testing to stem tide of new materials entering organization’s portfolio.

It is good industry practice for a company to make an MMP a mandatory requirement for its ingredient portfolio. A company could include requirements in its supplier purchase order or supplier contracts to ensure that vendors absorb the testing costs for an MMP, as the testing can be expensive, but passing these costs to vendors is currently a more commonly accepted practice today.

Additionally, where a company may not have the capacity to implement an MMP on its own, there are several third party laboratories that can manage a company’s MMP, and the company can require that the costs of this program be absorbed by its suppliers.

Table 1: Sample of Prioritizing Ingredient Groups Priority Material Group High Cereal (Grains) High Fruits High Dairy High Nuts Cocoa (excluding High beans) High Cocoa - Beans Medium Fat & Oil Medium Egg High Spices Medium Vegetable Medium Meat High Seeds Medium Fish Low Sweetener Low Food Chemicals Low Flavor Low Sugar Low Alcohol/Vinegar Low Hydrocolloids Low Starch, Gelatin Medium Color

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IV. Calculating Consumer Exposure in µg/day Using ppm/ppb as Mandated by Prop 65

A prop 65 warning is required if a consumer will be exposed to a listed chemical in excess of safe harbor levels. Under Prop 65, safe harbor levels are provided in units designated as µg/day. Often, however, lab test results quantifying the amounts of Prop 65 listed chemicals in foods are provided in ppm or ppb. Consequently, the lab test results in ppm/ppb must be converted to µg. Additionally, even with amounts to listed chemicals in µg, a company must also know the consumption frequency of the product being assessed, in order to determine whether the amount of the listed chemical in the food (in µg/day) multiplied by the consumption frequency of the food exceeds a safe harbor level.

Based on the foregoing, making an exposure determination of a Prop 65 listed chemical may require the following:7

• Laboratory test results of the amount of the Prop 65 listed chemical in the food (e.g., average amount of the listed chemical, often provided in ppm or ppb).

• Weight of the ingredient in the formulation or the weight of the product containing the listed chemical. (Using the weight of food (usually a serving size) and the average ppm/ppb amount of the listed chemical along with appropriate conversions provides the average level of compound (in µg) in the product.)

• Average daily rate of intake of product (can be less than 1 serving per day). (Multiplying the average level of the compound in the product in µg (often in a serving size) by the average daily consumption, provides the average daily exposure to the listed chemical.)

As provided in Figure 2 below, if the product after multiplying the average level of listed chemical (in µg) and the frequency of the daily consumption amount falls below the safe harbor level, a Prop 65 warning is not required, but if it exceeds the safe harbor level, a Prop 65 warning is required.

7 This information is adapted from the Exponent Consumption Intake Study, a document (PowerPoint) that is also included as part of this Prop 65 Technical Guide.

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Figure 2. Prop 65 Consumption Exposure Calculator8

Resources:

Glyphosate-free Certifications BioChecked Organization offers GMO Free and now Glyphosate-Free Certification to the food industry http://biochecked.com/ Guidance for Industry Acrylamide in Foods; https://www.fda.gov/downloads/Food/GuidanceRegulation/GuidanceDocumentsRegulat oryInformation/ChemicalContaminantsMetalsNaturalToxinsPesticides/UCM374534.pdf FoodDrinkEurope Acrylamide Toolbox; http://www.fooddrinkeurope.eu/uploads/publications_documents/AcrylamideToolbox_20 13.pdf A “Toolbox” for the Reduction of Acrylamide in Bread Products; http://www.fooddrinkeurope.eu/uploads/publications_documents/Toolboxfinal260911.pd f A “Toolbox” for the Reduction of Acrylamide in Fine bakery wares; https://ec.europa.eu/food/sites/food/files/safety/docs/cs_contaminants_catalogue_acryla mide_biscuits-final_en.pdf A “Toolbox” for the Reduction of Acrylamide in some Foods for Infants and Young Children;

8 May need to use conversion chart to assess µg/gram- http://www.endmemo.com/sconvert/ppbug_g.php

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https://ec.europa.eu/food/sites/food/files/safety/docs/cs_contaminants_catalogue_acryla mide_babyfood-final_en.pdf EFSA SCIENTIFIC OPINION Cadmium in food, 1 Scientific Opinion of the Panel on Contaminants in the Food Chain, (Question No EFSA-Q-2007-138) Adopted on 30 January 2009, Jan Alexander, Diane Benford, Andrew Cockburn, Jean-Pierre Cravedi, Eugenia Dogliotti, Alessandro Di Domenico, Maria Luisa Férnandez-Cruz, Peter Fürst, Johanna Fink-Gremmels, Corrado Lodovico Galli, Philippe Grandjean, Jadwiga Gzyl, Gerhard Heinemeyer, Niklas Johansson, Antonio Mutti, Josef Schlatter, Rolaf van Leeuwen, Carlos Van Peteghem, Philippe Verger, Parma, Italy; http://www.efsa.europa.eu/sites/default/files/scientific_output/files/main_documents/980. pdf Suggested citation: EFSA Panel on Contaminants in the Food Chain (CONTAM); Scientific Opinion on tolerable weekly intake for cadmium. EFSA Journal 2011;9(2):1975. [19 pp.] doi:10.2903/j.efsa.2011.1975. Available online: www.efsa.europa.eu/efsajournal © European Food Safety Authority, 2011 EFSA SCIENTIFIC OPINION, Statement on tolerable weekly intake for cadmium, Panel on Contaminants European Food Safety Authority (EFSA), Parma, Italy, EFSA Journal 2011;9(2):1975 [19 pp.].; http://www.efsa.europa.eu/en/efsajournal/pub/1975 EFSA SCIENTIFIC OPINION Comparison of the Approaches Taken by EFSA and JECFA to Establish HBGV for Cadmium, Panel on Contaminants European Food Safety Authority (EFSA), Parma, Italy, First published: 8 February 2011; http://onlinelibrary.wiley.com/doi/10.2903/j.efsa.2011.2006/epdf Scientific Opinion on Arsenic in Food, EFSA Journal, Panel members: Jan Alexander, Diane Benford, Alan Boobis, Sandra Ceccatelli, Jean‐Pierre Cravedi, Alessandro Di Domenico, Daniel Doerge, Eugenia Dogliotti, Lutz Edler, Peter Farmer, Metka Filipič, Johanna Fink‐Gremmels, Peter Fürst, Thierry Guerin, Helle Katrine Knutsen, Miroslav Machala, Antonio Mutti, Josef Schlatter, Rolaf van Leeuwen and Philippe Verger First published: 22 October 2009; http://onlinelibrary.wiley.com/doi/10.2903/j.efsa.2009.1351/epdf Scientific Opinion on Lead in Food, EFSA Journal, Panel members: Jan Alexander, Diane Benford, Alan Boobis, Sandra Ceccatelli, Jean‐Pierre Cravedi, Alessandro Di Domenico, Daniel Doerge, Eugenia Dogliotti, Lutz Edler, Peter Farmer, Metka Filipič, Johanna Fink‐Gremmels, Peter Fürst, Thierry Guerin, Helle Katrine Knutsen, Miroslav Machala, Antonio Mutti, Josef Schlatter and Rolaf van Leeuwen, First published: 20 April 2010; http://onlinelibrary.wiley.com/doi/10.2903/j.efsa.2010.1570/epdf Assessment of the dietary exposure to arsenic, cadmium, lead and mercury of the population of the EU Member States, Directorate-General Health and Consumer Protection. March 2004; https://ec.europa.eu/food/sites/food/files/safety/docs/cs_contaminants_catalogue_scoop _3-2-11_heavy_metals_report_en.pdf European Commission Links

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Chemical Safety Link http://ec.europa.eu/food/food/chemicalsafety/contaminants/ciaa_acrylamide_toolbox09. pdf Arsenic https://ec.europa.eu/food/safety/chemical_safety/contaminants/catalogue/arsenic_en https://ec.europa.eu/food/safety/chemical_safety/contaminants/catalogue/cadmium_en Lead https://ec.europa.eu/food/safety/chemical_safety/contaminants/catalogue/lead_en Cadmium https://ec.europa.eu/food/safety/chemical_safety/contaminants/catalogue/cadmium_en Mercury https://ec.europa.eu/food/safety/chemical_safety/contaminants/catalogue/mercury_en Furan/Furfuryl Alcohol Furan in heat processed food products including home cooked food products and ready-to-eat products http://onlinelibrary.wiley.com/doi/10.2903/sp.efsa.2009.EN-1/abstract Consumer exposure to furan from heat – processed food and kitchen air http://onlinelibrary.wiley.com/doi/10.2903/sp.efsa.2009.EN-30/abstract Update on furan levels in food from monitoring years 2004–2010 and exposure assessment http://onlinelibrary.wiley.com/doi/10.2903/j.efsa.2011.2347/abstract

18

DRAFT October 27, 2017

Memorandum

To: American Bakers Association

From: MaryJoy Ballantyne, Covington & Burling

Re: Overview of California's Proposition 65 Obligations for Food Manufacturers

I. Introduction At its core, Proposition 65 (California’s “Safe Drinking Water and Toxic Enforcement Act”) is a consumer “right-to-know” and “right-to-sue” statute. Adopted in 1986 by popular vote through California’s ballot initiative, “Prop 65” requires businesses to provide warnings to Californians about “exposures” to chemicals that are “listed” by the State as causing cancer, birth defects, or other reproductive harm.1 As a warning statute, Prop 65 does not prohibit or otherwise restrict the sale of products that contain listed chemicals in amounts that might exceed safety standards.

This white paper provides a general overview of relevant Prop 65 issues that may impact food companies, and in particularly manufacturers of baked goods. This document is not intended to provide legal advice.

II. Who is in charge of administering Prop 65? Under authority delegated it by the Governor, the California EPA Office of Environmental Health Hazard Assessment (OEHHA) is responsible for administering much of Prop 65, including administering the warning regulations, determining whether chemicals meet the scientific and legal requirements to be listed under Prop 65, providing Safe Use Determinations, and determining safe harbor levels for listed chemicals.

III. What is the Prop 65 warning requirement? As a consumer “right-to-know” statute, Prop 65 requires businesses with ten or more employees to provide a “clear and reasonable” warning before knowingly and intentionally exposing2 a person to any chemical listed by the State as causing cancer or reproductive harm at

1 See Cal. Health & Safety Code § 25249.6 (Prop 65 also prohibits California businesses from knowingly discharging significant amounts of listed chemicals into sources of drinking water). 2 “Expose” under Prop 65 regulations means “to cause to ingest, inhale, contact via body surfaces or otherwise coming into contact with a chemical. . . . an individual may come into contact with a chemical through water, air, food, consumer products and any other (continued…)

DC: 6553488-3

DRAFT October 27, 2017 Page 2 a level that exceeds allowable limits, based on the criteria discussed below.3 Consumer goods sold in California, including foods, are subject to the requirements of Prop 65 and therefore, potentially vulnerable to Prop 65 enforcement if non-compliant.

Under the Prop 65 regulations, OEHHA provides warnings that it deems are “clear and reasonable” and that therefore provide a “safe harbor” from enforcement actions.4 These “safe harbor” warnings are not mandatory and a business can choose to use other “clear and reasonable” warnings.

In August 2016, OEHHA finalized new “safe harbor” warnings, which become exclusively operative August 30, 2018. Until then, businesses who want to use a “safe harbor” warning can use either the new or old warnings. If a product is covered by a court-approved settlement, it can continue to use any warning covered by the settlement.

The “safe harbor” warnings are comprised of “content” requirements and “methods of transmission” requirements.

A. The current “Safe Harbor” warnings that sunset August 30, 2018 The content of the current “safe harbor” warnings for consumer products are as follows:

• For a listed carcinogen:

WARNING: This product contains a chemical known to the State of California to cause cancer.

• For a listed reproductive toxicant:

WARNING: This product contains a chemical known to the State of California to cause birth defects or other reproductive harm.

• For a chemical listed as both a carcinogen and reproductive toxicant (e.g., acrylamide):

environmental exposure as well as occupational or work place exposures.” 27 CCR 12201(e). Case law has interpreted “expose” to include when a listed chemical “comes into contact” with an individual. This means that to demonstrate a violation has occurred, a plaintiff does not need to demonstrate any actual harm, only that a listed chemical “comes into contact” with a person. 3 See Cal. Health & Safety Code § 25249.6. 4 See 27 CCR § 25600.

DRAFT October 27, 2017 Page 3

WARNING: This product contains a chemical known to the State of California to cause cancer and birth defects or other reproductive harm.

These warnings for consumer goods can be provided (e.g., the required “methods of transmission”) directly on the product label, on a sign at the point of display, or for on-line product sales, on the Internet page that has the description of the product.

B. The new “Safe Harbor” warnings that are operative now and exclusively after August 30, 2018

The major changes adopted and that apply generally to all the new “safe harbor” warnings require the warning to: (1) be provided prior to purchase rather than prior to exposure; (2) include the name of at least one chemical for which the warning is being provided (e.g., at least one carcinogen and at least one reproductive toxicant, of the product contains both), except when a truncated on-product warning is used; (3) be provided in a foreign language in addition to in English if the product contains consumer information in the foreign language; and (4) include the OEHHA Prop 65 url. (In addition, some warnings, but not food warnings, must use a symbol that is an exclamation mark in a black-outlined yellow triangle.)

The new “safe harbor” warnings include some that are “tailored” to specific products, including foods. The “tailored” food warning reads as follows (to be modified as needed depending on whether the food may expose consumers to a listed carcinogen, a listed reproductive toxicant, or both).

WARNING: Consuming this product can expose you to chemicals including [name of one or more chemicals], which is [are] known to the State of California to cause cancer and [name of one or more chemicals], which is [are] known to the State of California to cause birth defects or other reproductive harm. For more information go to www.P65Warnings.ca.gov/food.5

When used directly on the food product label, the “tailored” food warning must be enclosed in a box, set apart from other surrounding information, and comply with type size and other content requirements.6

The warning can be provided through any of the required “methods of transmission,” which are:

• An on-product warning.7

5 See revised Article 6, 27 CCR § 25607.2(a)(4). 6 See id.§ 25607.1(b).

DRAFT October 27, 2017 Page 4

• A product-specific warning provided on a posted sign, shelf tag, or shelf sign, for the product at each point of display.

• A product-specific warning provided via any electronic device or process that automatically provides the warning to the purchaser prior to or during the purchase,8 so long as purchasers do not have look for the warning.

For Internet purchases, a warning that complies with the content requirements must be provided by including either the warning of a clearly marked hyperlink using the word “WARNING” on the product display page, or by otherwise prominently displaying the warning to the purchaser prior to completing the purchase.9 If the product includes an on-product warning, the content of the website warning may be the same as the on-product warning.

The new safe harbor warnings also provide for use of a truncated warning directly on the product label. Although the regulations seem to have intended to exclude foods (and no other product) from using the truncated safe harbor warning, the regulations do not clearly prohibit the use of the truncated warning on foods and there is no reasonable basis that a truncated warning on food is not clear and reasonable if it is on every other consumer product.

Based on recent discussions with OEHHA, OEHHA will be proposing amendments to the Prop 65 safe harbor regulations to provide for a tailored truncated warning for foods that should be effective by August 2018. Depending on the whether the listed chemical(s) is a carcinogen, reproductive toxicant, or both, the content of the on-product tailored truncated food safe harbor warning will likely be enclosed in a box and read:

WARNING: Cancer - www.P65Warnings.ca.gov/food.

WARNING: Reproductive Harm - www.P65Warnings.ca.gov/food.

WARNING: Cancer and Reproductive Harm - www.P65Warnings.ca.gov/food.

7 See id.§ 25602(a). 8This provision is intended to capture existing and future methods of communication like electronic shopping carts, smart phone applications, barcode scanners, self-checkout registers, pop-ups on Internet websites, and any other electronic device that can immediately provide the consumer with the required warning. See OEHHA, Initial Statement of Reasons, 27 CCR, available at, http://oehha.ca.gov/media/downloads/crnr/112715warningreg20isor.pdf/ 9 See revised Article 6, 27 CCR § 25602(b).

DRAFT October 27, 2017 Page 5

IV. What chemicals are included on the Prop 65 list?

The Prop 65 list contains over 800 chemicals that include both synthetic and naturally occurring chemicals.10 Through specific procedures outlined in the statute, OEHHA includes chemicals on the Prop 65 list if they are “known” to cause cancer or reproductive harm.11 The statute requires the Prop 65 list to be updated annually, which, in rare exceptions may also include delisting chemicals (14 to date). Once a chemical is included on the Prop 65 list, there is a one-year grace period, after which the warning obligation becomes operative (e.g., the listing of furfuryl alcohol was effective September 30, 2016 but not enforceable until September 30, 2017; the listing of glyphosate was effective July 7, 2017 but will not be enforceable until July 7, 2018).

V. How do I determine if a Prop 65 warning is required? For listed chemicals that are identified as carcinogens, a warning is required unless exposure is low enough that it poses “no significant risk level” (NSRL), which is not more than one case of cancer in an exposed population of 100,000, assuming 70-year lifetime exposure at the level in question.. For listed chemicals that are reproductive toxicants, a warning is required unless exposure is significantly below (1/1000th) the level observed to cause birth defects or other reproductive harm (this level is known as the maximum allowable dose level (MADL)). This means that the presence of a listed chemical in a food does not per se trigger the warning requirements--the warning requirements are triggered only if the level of “exposure” from the food is above the NSRL and/or MADL.

A. Has OEHHA established any “safe harbor” levels? OEHHA has provided NSRLs and/or MADLs--known as “safe harbor” levels--for about 300 of the 800+ listed chemicals, including a NSRL and MADL for acrylamide and a proposed NSRL for glyphosate, but not a NSRL for glyphosate.12 If the “exposure” to a listed chemical in a food falls at or below the applicable NSRL and/or MADL, no warning is required.

Listed chemical Cancer (NSRL) Reproductive harm (MADL)

10 As of October 2017, 596 are listed as carcinogens, 314 as reproductive toxicants, and 65 as both, see Proposition 65 list. 11 Learn how chemicals are added to the list. 12 Proposition 65 Safe Harbor Levels: No Significant Risk Levels for Carcinogens and Maximum Allowable Dose Levels for Chemicals Causing Reproductive Toxicity, available at https://oehha.ca.gov/proposition-65/general-info/current-proposition-65-no-significant-risk- levels-nsrls-maximum, which includes 256 NSRLs and 52 MADLs.

DRAFT October 27, 2017 Page 6

Acrylamide Jan. 1, 1990 (0.2 µg/day) Feb. 25, 2011 (140 µg/day) Furfuryl alcohol Sep. 30, 2016 NA Glyphosate July 7, 2017 (proposed 1100 NA µg/day)

B. What if OEHHA has not established a “safe harbor” level, can a company do so? How does a company calculate exposure?

Simply because OEHHA has not provided a NSRL and/or MADL for a listed chemical does not mean one does not exist--NSRLs and MADLs exist separate from whether OEHHA has determined a “safe harbor” level. Where OEHHA has not provided a “safe harbor” level, companies can use product testing with validated methods to quantify the chemical, product consumption data, and toxicological assessments to determine safe exposure levels.

Once the company has established a safe harbor level--i.e., a NSRL and/or MADL--the company will need to assess the level of exposure from a product to the listed chemical(s). Exposure is not assessed based upon the package size or the amount used per occasion. Rather, exposure is typically calculated by multiplying the level (e.g., in ppm or ppb) of the listed chemical(s) in the food by the amount of the product consumed per day by the average consumer.13 Under present law, daily exposure has been assessed based upon average exposure over time, reflecting both days on which the product is consumed and days on which it is not consumed.14 If OEHHA adopts pending proposals, it would materially affect this approach to averaging. In some cases, such as for acrylamide and furfuryl alcohol where chemical levels may be linked to the amount and extent of thermal processing, a company may need to understand exposure levels for reasonably foreseeable uses of products (e.g., it is reasonable that consumers toast bread, which may increase the level of acrylamide and/or furfuryl alcohol).

Establishing safe harbor levels and calculating exposure can be challenging, but not impossible, and may require the assistance of experts in toxicology and food consumption assessments.

C. What if a listed chemical is “naturally occurring” in the food? For foods, Prop 65 regulations include an exception to the warning requirements for chemicals that are “naturally occurring” in the food: “human consumption of a food shall not

13 See CCR §§ 25721, 25821. 14 See, e.g., California v. Tri-Union Seafoods, LLC, 2006 WL 1544384 (Cal. Sup. Ct. May 11, 2006) (exposure to mercury in tuna fish assessed based on average amount consumed per day over a two month period), aff’d, 171 Cal.App.4th 1549 (2009).

DRAFT October 27, 2017 Page 7 constitute an ‘exposure’ . . . to a listed chemical in the food to the extent that the person responsible for the exposure can show that the chemical is naturally occurring in the food.”15 This exception often has limited utility because a chemical is only “naturally occurring” to the extent it did not result “from any known human activity” and, if a contaminant in the food, “only to the extent that it was not avoidable by good agricultural or good manufacturing practices.”16 The regulations require evidence from the company responsible for the exposure that the food at all times was subject to quality control measures that reduce natural chemical contaminants to the “lowest level currently feasible,” as this term is used in 21 CFR 110.110(c).17

D. What if a listed carcinogen is the result of cooking? Limited only to chemicals listed as carcinogens, the Prop 65 regulations allow companies to establish NSRLs based on criteria other than one case of cancer in an exposed population of 100,000 assuming lifetime exposure at the level in question, if the chemical(s) in the food “are produced by cooking necessary to render the food palatable or to avoid microbiological contamination.”18 The practical utility of this provision is unclear because a company presumably must still establish a NSRL based on sound scientific evidence and the NSRL, in turn, would need to be linked to the minimum level of cooking necessary for palatability or safety from microbiological contamination.

E. What if a company chooses to test its products for Prop 65 listed chemicals? Whether or not to test products for Prop 65 listed chemicals is a business decision. In a litigation or enforcement proceeding, test results may be discoverable, but the absence of product testing to determine potential exposes to Prop 65 listed chemicals does not absolve a company of its obligation to provide a warning if a warning is required. Sometimes, there may be sufficient information in the scientific literature to make initial conclusions on the potential level of listed chemicals in certain food products, but this information would not suffice if a product was targeted in a Prop 65 action. The burden is always on the company responsible for a exposure to a listed chemical to demonstrate that a warning is not required.

If a company does choose to test its products for Prop 65 listed chemicals, neither Prop 65 nor OEHHA prescribe the testing method to use. As a general matter, the testing should allow for a determination of safe use based on evidence and standards of comparable scientific validity to those that used as the scientific basis for the listing of the relevant chemicals being tested. The company should be confident that it is using methods that are validated and

15 Cal. Health & Safety Code § 25501(a). 16 Id. § 25501(b)(3), (4). 17 Id. 18 Id. § 25703(b)(1).

DRAFT October 27, 2017 Page 8 sufficiently sensitive to consistently and accurately detect and quantify the chemicals. For example, if there is a “safe harbor” level (e.g., a NSRL or MADL established by OEHHA or by the company), the testing method should use a limit of detection that is low enough so that the chemical level from the test results can be used in conjunction with the amount of product consumed per day in ordinary use to calculate average exposure levels. If a company uses an external testing laboratory, the company should be confident that the testing laboratory is qualified and is using the best available methods.

VI. Are there any other options for mitigating potential liability for Prop exposures from foods other than providing a warning or reformulating?

One possibility for mitigating potential liability under Prop 65 is to obtain a Safe Use Determination (SUD) from OEHHA.19 A SUD is a statement from OEHHA that use of a specific product is at or below a safe harbor level.20 The Prop 65 regulations provide the specific requirements for submitting a SUD by an impacted business (or trade association on behalf of impacted businesses) and the type of information that must be included in a SUD. A SUD request, however, cannot be submitted if the subject matter is currently being litigated or otherwise subject to an enforcement action. In addition, a SUD from OEHHA is only applicable to the specific products, listed chemicals, and uses specified in the determination.

The cost of a SUD varies, depending on the level of review required by OEHHA, but includes a $1,000 initial non-refundable processing fee, initial review costs, and evaluation costs. Timing of receiving a final SUD determination is also variable, but depends largely on the quality and completeness of the submission and the complexity of the issues.21

VII. Who is liable under Prop 65 and who has the burden of establishing whether a warning is required?

The way it is written, Prop 65 applies to all entities in an impacted product’s distribution chain, including a manufacturer, distributor, retailer, or other entity.22 From a practical perspective and in OEHHA’s opinion, however, the manufacturer of an impacted product has the most knowledge about the product’s composition, and thus has the primary responsibility for determining whether a warning is required, and if so, for ensuring that a warning is provided.

19 Examples of SUDs issued by OEHHA in the past and information on current SUD activity are available at: https://oehha.ca.gov/proposition-65/proposition-65-safe-use-determinations-sud 20 27 CCR § 25204. 21 Id. §§ 25201, 25203, & 25204 22 “No person in the course of doing business shall knowingly and intentionally expose an individual to a chemical known to the state to cause cancer or reproductive toxicity without first giving clear and reasonable warning to such individual [with exceptions].”

DRAFT October 27, 2017 Page 9

As a result, enforcement and litigation is most often against the product manufacturer, but it is not unusual to see both a manufacturer and a retailer jointly targeted and named as defendants. When a retailer is targeted either solely or jointly, it is reasonable to presume that resolution of the matter will depend largely on information provided by the manufacturer and that if not already, the manufacturer may become involved if it indemnified the retailer.

VIII. Who can initiate an enforcement action under Prop 65 and what are the potential penalties?

Prop 65 gives the California Attorney General the right to enforce and private citizens acting in the public interest the right to sue under Prop 65.23 Any district attorney or city attorney (for cities whose population exceeds 750,000) may also enforce Prop 65. The vast majority of Prop 65 challenges are private suits brought by a relatively small number of law firms and public interest groups (also known as “bounty hunters”).

Penalties for Prop 65 violations are up to $2,500 per violation (typically, there is one “violation” for each violative product, which can lead to a significant penalty) and private plaintiffs are awarded (by statute) 25% of any assessed penalty amount.

Private actions begin with a “60-Day Notice” letter that sets out the alleged Prop 65 violation and sometimes the demand for relief. The notice provides that the plaintiff intends to bring litigation against the company within 60 days, unless the Attorney General decides to sue the company first. Most often, the 60-Day Notice letters allege an exposure occurred without the proper warning. Once a company receives a 60-Day Notice letter, the company has the burden of proving that the alleged violation has not occurred.

Most private actions result in settlements that may require any or all of the following: injunctive relief (stopping the sales of product until properly labeled or formulated to fall within specified allowable level of the chemical in the product, based on reasonable assumptions as to safe harbor limits and the amount and frequency of product consumption/exposure); regular product testing to demonstrate compliance; specific warnings if the level of the chemical in the product exceed the specified allowable level; reformulation; financial penalties. As of October 2017: • >22,199 Prop 65 60-day notice letters have been filed. • >47,000 separate businesses have been targeted. • ~5,384 Prop 65 lawsuits have been filed (117 by the state Attorney General). • >5,539 Prop 65 cases have been settled (most brought by private plaintiffs). • >$268M in penalties and fees has been paid, 90% to private plaintiffs.

23 California Attorney General's Office

DRAFT October 27, 2017 Page 10

• The average settlement from 2014 - 2016 was ~$40K based on ~2K settlements, with >$77M in settlements approved during this time.

IX. What are some things a company can keep in mind when managing its Prop 65 obligations?

The following are some points that a company could keep in mind in considering whether and how to manage its obligations under Prop 65:

• Know whether your products are sold in California.

• Develop internal policies on whether the company will assess products for the presence of Prop 65 compliance, how to conduct an assessment, and what to do with the results of such assessments. Depending on whether a company chooses to test products or not, company policies could include:

o How to stay current with Prop 65 listed chemicals and relevant Prop 65 60- notices, litigation, and settlements.

o Whether and how to test products (including, e.g., testing methodologies specific to listed chemicals potentially in company products; contact information for external testing laboratories).

o Where a OEHHA NSRL or MADL exists, how to conclude and ensure that such safe harbors are sufficiently high that there is no risk of exposure in excess of the safe harbor (e.g., relying on existing scientific studies for the chemical and food such that no product testing is required).

o In the absence of an OEHHA NSRL or MADL, whether and how to determine if a safe use level exists and whether and how to conduct “exposure” risk assessments (e.g., reviewing the relevant scientific literature applicable to the listed chemical and foods to determine NSRLs and/or MADLs and/or whether any levels of the chemical are naturally occurring and likely levels of exposure based on likely quantity and frequency of exposure; contact information for subject matter experts in toxicology and food consumption assessments).

o Procedures for what the company will do if its risk assessments conclude a product might result in a violative exposure (e.g., provide a warning, reduce “contaminant” chemicals to the lowest amount feasible and reformulate within safe harbor levels).

• Develop internal policies for how the company will respond to a 60 day notice letter or enforcement action. Such policies could include the following actions:

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o Contacting legal counsel to help evaluate the matter.

o If the letter/complaint identifies other defendants or if there is similar pending litigation, having the company’s counsel contact the counsel of the other named or similarly situated defendants (to ensure consistency in defense and harmonize legal strategies, where possible).

o Contact the noticing party to discuss the alleged violations and request/obtain any testing (or testing methodologies) or data from the plaintiff (the plaintiff is not required to provide this). Conduct product testing and/or obtain an exposure assessment. The company and/or its counsel can evaluate information from the plaintiff and any product testing or exposure assessment to determine whether the claim has merit.

o Consider whether and when to hold distribution of product into California and whether and how to manage product on retail shelves (e.g., recall product and/or provide warnings).

• If your company is engaged in Prop 65 litigation or enforcement action, ensure the settlement provides, where feasible and applicable, adequate coverage for all relevant Prop 65 listed chemicals and for as many impacted products as possible, a reasonable allowable level of the chemical in the product, a reasonable warning to be triggered only if that allowable level is exceeded, a reasonable compliance period, and reasonable attorney fees. The settlement should also be subject to judicial approval so that it has as much preclusive effect as possible against the same and similar lawsuits.24

24 Generally, if a Prop 65 settlement is reached out of court (i.e., before a complaint has been filed and without judicial approval), the plaintiff can release claims on its own behalf, but not “in the public interest.” This means that the same plaintiff could not sue the same company over the same violations, but a different private plaintiff or public enforcer could sue the same company over the same violations. If the settlement is approved by a court, then the settlement should preclude other private plaintiffs from bringing additional lawsuits. Center for Chemical Regulation and Food Safety

INTAKE ESTIMATES OF SELECT BAKED GOODS

INTAKE ESTIMATES OF SELECT BAKED GOODS

Prepared for

Rasma I. Zvaners Vice President, Regulatory & Technical Services American Bakers Association 601 Pennsylvania Avenue, NW, Suite 230 Washington, DC 20004

Prepared by

Exponent, Inc. 1150 Connecticut Avenue, NW Suite 1100 Washington, DC 20036

March 29, 2018

 Exponent, Inc.

1708708.000 – 7281 Center for Chemical Regulation and Food Safety

Table of Contents

Page

List of Tables 4

List of Acronyms 5

Introduction 6

Data and Methods 8

Consumption Data 8 NHANES 24-Hour Recall 9 NHANES Food Selection 9 Food Frequency Questionnaire 10 NHANES FFQ Food Selection 10

Analysis 13 Estimates of Usual (Long-Term) Intake 15

Results 16

References 20

Appendix I. Food Codes Included In Analysis 22

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Center for Chemical Regulation and Food Safety

List of Tables

Page

Table 1. Food Categories Included in Assessment 8

Table 2. Summary of NHANES and FFQ food selection 11

Table 3. Per user two-day average estimated intake of select food categories by the total U.S. population (g/day); NHANES 2011-2014 17

Table 4. Estimated amount per eating occasion (g/EO), frequency of consumption (EO/day), and usual intake (g/day) of select food categories by the total U.S. population 18

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Center for Chemical Regulation and Food Safety

List of Acronyms

CDC Centers for Disease Control and Prevention CFR Code of Federal Regulations d Day DHHS Department of Health and Human Services EDI Estimated daily intake EO Eating occasion FARE® Foods Analysis and Residues Evaluation Program® FFQ Food Frequency Questionnaire FNDDS Food and Nutrient Database for Dietary Studies g Gram MADL Maximum Allowable Dose Level NCHS National Center for Health Statistics NHANES National Health and Nutrition Examination Survey NSRL No Significant Risk Level OEHHA Office of Environmental Health Hazard Assessment U.S. United States USDA U.S. Department of Agriculture WWEIA What We Eat in America y Year

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Center for Chemical Regulation and Food Safety

Introduction

At the request of the American Bakers Association (ABA), Exponent conducted an intake assessment to estimate the two-day average and usual (long-term) intake of 16 food categories. The estimated consumption of the 16 food categories was based on food consumption data from the 2011-2014 National Health and Nutrition Examination Survey (NHANES) whereas the usual (long-term) intake was based on food consumption data from the 2011-2014 NHANES in combination with the frequency of consumption data based on responses to the Food Frequency Questionnaire (FFQ) collected as part of NHANES 2003-2006.

The objective of this analysis was to derive a screening level estimate of dietary intake of the 16 food categories for the purpose of assuring compliance with the Safe Drinking Water and Toxic Enforcement Act of 1986. This Act was enacted as a ballot initiative in California in 1986 and is known as Proposition 65. As part of this regulation, all businesses must warn and notify California residents about compounds in food products they purchase that cause cancer, birth defects, or other reproductive effects. California’s Office of Environmental Health Hazard Assessment’s (OEHHA) “safe harbor” levels are based on a No Significant Risk Level (NSRL) for cancer-causing chemicals and Maximum Allowable Dose Level (MADL) for chemicals causing reproductive toxicity 1. According to OEHHA, exposures that are below the safe harbor levels are exempt from the requirements of Proposition 65.

Intake estimates based on the arithmetic mean of the consumption distribution are conservative since this central tendency estimate tends to overstate consumption when the underlying distribution is skewed towards higher intake estimates, as is the case with most consumption data. In the case of skewed consumption data, the geometric mean is the more appropriate measure of an average or central estimate and basis for an exposure assessment

1 https://oehha.ca.gov/proposition-65/proposition-65-list/ (accessed March 26, 2018).

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Center for Chemical Regulation and Food Safety used to assess compliance with Proposition 65. Further, the consumption estimates based on two days of dietary intake are generally not reflective of usual (long-term) intake. For many foods, especially among infrequently consumed foods, two days of intake will overestimate consumption and thus provide a conservative estimate of exposure. For this reason, it is best to include frequency of consumption as well as the amount consumed to estimate usual intake. Therefore, Exponent also combined the two days of consumption data with frequency of consumption data to estimate longer-term intake. Consumption estimates are provided on a per user basis at the arithmetic and geometric mean for the total United States (U.S.) population. The data and methods used to conduct the intake assessment and results are summarized in this report.

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Center for Chemical Regulation and Food Safety

Data and Methods

An intake assessment was conducted for 16 food categories that were provided to Exponent by ABA and are presented in Table 1.

Table 1. Food Categories Included in Assessment

Food Category 1 Enriched bread, rolls, and buns ( 21 CFR § 136.115) 2 Milk bread, rolls, and buns ( 21 CFR § 136.130) 3 Raisin bread, rolls, and buns ( 21 CFR § 136.160) 4 Whole wheat bread, rolls, and buns ( 21 CFR § 136.180) 5 Potato bread, rolls and buns 6 Variety breads (rye; pumpernickel; whole grain; 7 -12 grain breads/rolls; pulse and vegetable) 7 Biscuits 8 Donuts 9 Cookies 10 Crackers, crisp (enriched; whole grain; rye) 11 Croutons and stuffing 12 Flat breads (naan/focaccia) 13 Tortillas (flour and corn) 14 Breading (Panko type used in further processing) 15 Ice cream inclusions (wafers, cones, broken cookie pieces or crumbs) 16 Baby food: teething crackers/biscuits

Consumption Data

The estimated intakes of the 16 food categories were based on food consumption records collected in the What We Eat in America (WWEIA) component of NHANES conducted in 2011- 2012 and 2013-2014 (NHANES 2011-2014). This continuous survey is a complex multistage probability sample designed to be representative of the civilian U.S. population (NCHS 2014, 2016). The NHANES datasets provide nationally representative nutrition and health data and prevalence estimates for nutrition and health status measures in the United States. Statistical weights are provided by the National Center for Health Statistics (NCHS) to adjust for the differential probabilities of selection.

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Center for Chemical Regulation and Food Safety

NHANES 24-Hour Recall

As part of the examination, trained dietary interviewers collected detailed information on all foods and beverages consumed by respondents in the previous 24 hour time period (midnight to midnight). A second dietary recall was administered by telephone three to ten days after the first dietary interview, but not on the same day of the week as the first interview. The dietary component of the survey is conducted as a partnership between the U.S. Department of Agriculture (USDA) and the U.S. Department of Health and Human Services (DHHS). DHHS is responsible for the sample design and data collection, and USDA is responsible for the survey’s dietary data collection methodology, maintenance of the databases used to code and process the data, and data review and processing. A total of 15,179 individuals in the survey period 2011-2014 provided 2 complete days of dietary recalls.

NHANES Food Selection

Consumption data in the NHANES survey are reported on an “as consumed basis”. That is, if a survey participant consumed an apple pie, the consumption amount reported in the survey for that subject would be for the amount of pie consumed, and not for the ingredients (e.g., flour, butter, apples, sugar, etc.) used to make that pie. Exponent utilized the Food and Nutrient Database for Dietary Studies (FNDDS) to identify the component in “as consumed” foods in NHANES that correspond to food categories of interest. The FNDDS was developed by the U.S. Department of Agriculture (USDA) and translates the food as consumed into its corresponding ingredients (and gram amounts) or recipes. NHANES foods were selected using the FNDDS database for the following food categories:

• Enriched bread, rolls, and buns (21 CFR § 136.115) • Whole wheat bread, rolls, and buns (21 CFR § 136.180) • Variety breads (rye; pumpernickel; whole grain; 7-12 grain breads/rolls; pulse and vegetable) • Biscuits • Croutons and stuffing

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• Flat breads (naan/focaccia) • Tortillas (flour and corn) • Breading (Panko type used in further processing) • Ice cream inclusions (wafers, cones, broken cookie pieces or crumbs)

Identification of the weight of ingredients in foods allowed for the estimation of the foods of interest that can be reported consumed as is or as a component in a food (e.g., breads and biscuits in sandwiches, tortillas in Mexican foods, etc.). Exponent applied FNDDS version 2013- 2014 recipes (which corresponds to dietary consumption for NHANES 2013-2014) (USDA 2016a) to process dietary recall data reported in NHANES 2011-2014 and FNDDS version 2011-2012 recipes (which corresponds to dietary consumption for NHANES 2011-2012) (USDA 2014a) for foods that were only reported consumed in NHANES 2011-2012.

NHANES foods corresponding to all other food categories were identified based on the food description. A summary of the NHANES food selection for each food category of interest is provided in Table 2. The list of all NHANES food codes (and their descriptions) included in the analysis can be found in Appendix I.

Food Frequency Questionnaire

The frequency of consumption of the food categories of interest (i.e., eating occasion per day (EO/day)) was assessed using the NHANES 2003-2006 food frequency questionnaire (FFQ). The NHANES FFQ contains 151 frequency questions and asks NHANES participants 2+ years of age to estimate their frequency of consumption of specific categories of food based on their consumption patterns over the past 12 months (NCHS 2007, 2008). The FFQ food categories are broader than the individual foods reported in the NHANES 24-hour dietary recall.

NHANES FFQ Food Category Selection

The FFQ food categories are broader than the individual foods reported in the NHANES 24-hour dietary recall. In some cases, the category of interest directly mapped to the FFQ (i.e., the

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Center for Chemical Regulation and Food Safety biscuits category was mapped to the biscuits FFQ food, and the tortillas category was mapped to the tortillas/tacos FFQ food) while for most of the other categories, the FFQ food encompassed more than the food category of interest. Therefore, Exponent mapped the food categories of interest to one or more FFQ food category. For example, there was no FFQ food category specific to enriched, milk, raisin, whole wheat, potato, or variety bread; however, the FFQ does have two categories of 1) white bread/rolls and 2) not white bread/rolls. Therefore, enriched and raisin bread categories of interest were mapped to the white breads/rolls FFQ food category and milk, whole wheat, potato, and variety bread categories of interest were mapped to the not white breads/rolls FFQ food category. In other instances, there was no single FFQ food category that matched or encompassed the food category of interest (i.e., croutons and stuffing and breading) and in these cases, the category was mapped to more than one FFQ food category under the assumption that the frequency of consumption of the combined FFQ food categories would be representative of the frequency of consumption of the food category of interest. Thus, using the NHANES 2003-2006 FFQ data to represent the frequency of consumption of many of the food categories will likely overestimate the actual frequency of consumption of some categories if the FFQ food categories include foods beyond the category of interest (but the usual “intake” derived using the FFQ data would still be expected to be below the two-day average estimate derived from the 24-hour recall alone).

A summary of the NHANES food selection and the FFQ mapping for each food category of interest is provided in Table 2. The frequency of consumption of baby foods are not collected in the NHANES FFQ, therefore, the category of teething crackers/biscuits (baby food) could not be mapped.

Table 2. Summary of NHANES and FFQ food selection

Food Category NHANES Food Selection Summary FFQ Food 1 Enriched bread, rolls, White breads, rolls, and buns; Cuban, Breads/rolls, white and buns (21 CFR § French or Vienna, Italian, and flatbread; 136.115) breads not specific as to major flour; and includes the component in sandwiches, burgers, and mixtures such as meat loaf,

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Food Category NHANES Food Selection Summary FFQ Food bread pudding, etc. 2 Milk bread, rolls, and Milk breads not reported consumed. Breads/rolls, not white buns (21 CFR § Breads not specific as to major flour 136.130) selected as surrogate. 3 Raisin bread, rolls, and Raisin bread (includes raisin pita bread); Breads/rolls, white buns (21 CFR § breads not specific as to major flour. 136.160) 4 Whole wheat bread, Whole wheat bread (including French or Breads/rolls, not white rolls, and buns (21 CFR Vienna, pita), rolls, buns; breads not § 136.180) specific as to major flour; and includes the component in sandwiches. 5 Potato bread, rolls and Potato bread and breads not specific as Breads/rolls, not white buns to major flour. 6 Variety breads (rye; Breads, rolls, and buns including bran, Breads/rolls, not white pumpernickel; whole white with whole wheat swirl, garlic, grain; 7-12 grain onion, high protein, sweet potato, breads/rolls; pulse and vegetable, sprouted wheat, whole grain vegetable) white, wheat or cracked wheat, rye, pumpernickel, black, oatmeal, oat bran, multigrain, sunflower meal, breads not specific as to major flour, and includes the component in sandwiches. 7 Biscuits Biscuit and the component in breakfast Biscuits sandwiches. 8 Donuts Donuts, all types Doughnuts/Sweet Rolls/Danish/Pop Tarts 9 Cookies All types such as almond, biscotti, Brownies/Cookies cookie bars, cookie sandwiches, cookie wafer, fruit filled, oatmeal, peanut butter, marshmallow cookie, shortbread, animal cookie, etc. 1 10 Crackers, crisp Crackers not specific as to type, melba Crackers (enriched; whole grain; toast, zwieback toast, toast thins, high rye) fiber crackers (such as WASA Fiber- Plus Crisp Bread), white and rye crispbread, 100% whole wheat crackers (such as Triscuit), wheat (such as Wheatables, Wheat Thins, Keebler Multigrain Club Crackers, Ritz Crackers with Whole Wheat). 11 Croutons and stuffing Croutons and dry stuffing and its Stuffing/dumpl ings; component in mixtures such as ham lettuce salads stuffing, dressing with oysters, and salads. 12 Flat breads Focaccia, naan, pita, Indian breads Breads/rolls, white and

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Food Category NHANES Food Selection Summary FFQ Food (naan/focaccia) (chappatti, roti, paratha), injera, pita and not white 2 its component in sandwiches. Includes regular, wheat, whole wheat types. 13 Tortillas (flour and corn) Tortilla (corn, flour, whole wheat), taco Tortillas/Tacos shell (corn, flour), and gordita/sope shell and its component in wrap sandwiches, burritos and tacos, other Mexican dishes, and soups. 14 Breading (Panko type Breading/bread crumb component in Tuna; Ground Beef in used in further breaded or coated meats and seafood, Mixtures; Chicken processing) casseroles, meat cake or patty, meat salads/mixtures; Chicken loaf, and pasta dishes. (not in a salad/mixtures); Fried Fish/Fish sticks 15 Ice cream inclusions Ice cream cones (i.e., cake or wafer - Ice Cream/Ice Cream (wafers, cones, broken type, sugar rolled-type) and its Bars/Sherbet cookie pieces or crumbs) component ice cream desserts 3. 16 Baby f ood: teething Baby cookies (i.e., fruit, teething, rice) Not available crackers/biscuits and crackers 1 Food codes reported consumed in NHANES does not allow for the distinction between soft and crisp cookies. 2 FFQ food for white and not white breads/roll mapped to the category of flat breads because selected flat bread NHANES codes included regular, wheat, and whole wheat varieties. 3 Selection limited to ice cream cones because NHANES does not have a code specific to ice cream inclusions and does not provide information on cookie pieces or crumbs on ice cream and frozen dairy desserts.

Analysis

Two sets of consumption estimates were derived: 1) two-day average consumption of the 16 food categories as recorded by the respondents over the two days of dietary recalls collected in NHANES and 2) usual (long-term) consumption of the 16 food categories by combining data on the frequency of eating occasions from the NHANES FFQ with the amount consumed in a single eating occasion from the two days of dietary recalls within NHANES. The two-day average consumption estimates and the amount per eating occasion were reported on a per user basis. Per user estimates refer to those who reported consuming any of the foods of interest within a given food category on either of the survey days. Thus, if a participant reported consuming the food on day 1 but not on day 2, they would be considered a “user” and their two-day average consumption is the amount they reported consumed on day 1 divided by 2. The average intake amount of food products per EO was estimated based on the amount that is reported consumed on a single EO (g/EO) from the 24-hour dietary recall. The analysis was limited to

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Center for Chemical Regulation and Food Safety individuals who provided two complete and reliable dietary recalls as determined by NCHS. Exponent uses the statistically weighted values from the survey in its analyses. The statistical weights compensate for variable probabilities of selection, adjust for non-response, and provide intake estimates that are representative of the U.S. population.

Per user intakes were estimated at the mean (arithmetic and geometric) using Exponent’s Foods Analysis and Residues Evaluation Program (FARE ® version 12.27) software. Exposure estimates and risk characterization according to OEHHA should be based on the average consumer. As stated in the Proposition 65 regulations at Title 27 of the California Code of Regulations section 25821(c)(2): “For exposures to consumer products, the level of exposure shall be calculated using the reasonably anticipated rate of intake or exposure for average users of the consumer product, and not on a per capita basis for the general population.” For that reason, non-consumers are not intended for consideration in the risk process. The analysis presented in this report provides consumption estimates among consumers of the food categories of interest (i.e., per user ). Further, where the consumption data is not normally distributed (i.e., bell-shaped) but rather skewed (e.g., lognormal), as is typically the case for consumption distributions, the arithmetic mean is not the most appropriate estimate of usual consumption. If the data are skewed, the highest (and lowest) statistical values in the distribution curve can distort the estimate of an average if the arithmetic mean is used. Rather, for skewed consumption data, estimates based on the geometric mean are most appropriate since the geometric mean is less influenced by the highest and lowest statistical values.

Consumption estimates based on two days of dietary intake is most often not reflective of long- term or usual intake. For many foods, especially among infrequently consumed foods, two days of intake will overestimate consumption. For this reason, it is best to include frequency of consumption as well as the amount consumed to estimate long term intake. Therefore, the two-day average intake estimates provided in this report will provide a conservative assessment of consumption appropriate for screening purposes.

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Estimates of Usual (Long-Term) Intake

To estimate the average consumer’s usual (long-term) intake of a food, the frequency at which the food is consumed (i.e., EO per day/week/month/year/etc.) needs to be included. For foods that an average consumer does not consume on an uninterrupted daily basis, failure to account for frequency over time would result in over-estimating the amount of consumption of those foods.

Estimates of long-term intakes of select food categories were derived on a per user basis and by combining the NHANES 2003-2006 FFQ with the amount per eating occasion from the NHANES dietary data. The average intake amount of foods within a food category of interest per EO was estimated based on the amount that is reported consumed on a single EO (g/EO) from the NHANES 2011-2014 24-hour dietary recall, as described above. The average frequency of consumption of the corresponding foods (EO/day) among the U.S. population 2 years and older was derived using the FFQ data. The estimated long-term (usual) intake was calculated using the following equation:

g g EO Usual daily intake of food = mean intake amount × mean frequency of consumption
day   EO   day

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Results

The per user two-day average intake at the mean (arithmetic and geometric) for each of the 16 food categories of interest for the total U.S. population are summarized in Table 3. The estimated amount per eating occasion (g/EO), frequency (EO/day), and usual intake (g/day) at the mean (arithmetic and geometric) by food category for the total U.S. population are presented in Table 4.

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Table 3. Per user two-day average estimated intake of select food categories by the total U.S. population (g/day); NHANES 2011-2014 Per User two-day average intake (g/day) Arithmetic Geometric Food Categories N* % User Mean Mean 1 Enriched bread, rolls, and buns ( 21 CFR § 8,353 59 47.7 36.0 136.115) 2 Milk bread, rolls, and buns ( 21 CFR § 136.130) a 91 0.4 27.5 22.9 3 Raisin bread, rolls, and buns ( 21 CFR § 136.160) 192 1 23.7 20.5 4 Whole wheat bread, rolls, and buns ( 21 CFR § 1,906 14 39.9 33.3 136.180) 5 Potato bread, rolls and buns 140 1 32.2 26.6 6 Variety breads (rye; pumpernickel; whole grain; 7 - 4,129 28 39.5 32.8 12 grain breads/rolls; pulse and vegetable) 7 Biscuits 1,119 8 39.4 32.1 8 Donuts 871 6 37.9 31.4 9 Cookies 4,899 32 30.1 22.5 10 Crackers, crisp (enriched; whole grain; rye) 507 5 15.3 11.6 11 Croutons and stuffing 518 5 8.2 3.8 12 Flat breads (naan/focaccia) 498 3 44.2 32.6 13 Tortillas (flour and corn) 4,089 28 57.5 40.4 14 Breading (Panko type used in further processing) 2,829 18 8.6 5.8 15 Ice cream inclusions (wafers, cones, broken 512 3 3.5 3.0 cookie pieces or crumbs) b 16 Baby food: teething crackers/biscuits 75 0.2 11.5 6.7 * Unweighted number of users; %user and per user mean estimates derived using the statistical weights provided by the NCHS. a Milk breads not reported consumed, therefore, NHANES bread codes that do not specify the main flour type was used as a surrogate to derive intake estimates. b Intake estimates limited to ice cream cones (i.e., cake or wafer-type, sugar rolled-type) and its component ice cream desserts. Unable to capture cookie pieces or crumbs as NHANES does not have a code specific to ice cream inclusion and does not provide information on cookie pieces or crumbs on ice cream and frozen dairy desserts.

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Table 4. Estimated amount per eating occasion (g/EO), frequency of consumption (EO/day), and usual intake (g/day) of select food categories by the total U.S. population

Amount Consumed per Eating Occasion a Frequency of Consumption b Usual Intake c Arithmetic Geometric Arithmetic Geometric Arithmetic Geometric % Mean Mean Mean Mean Mean Mean Food Categories N* User - - - g/EO - - - FFQ Food - - - EO/day ------g/ day - - - 1 Enriched bread, rolls, and 8,353 59 56.9 46.9 Breads/rolls, white 0.43 0.22 24.5 10.3 buns (21 CFR § 136.115) 2 Milk bread, rolls, and buns 91 0.4 50.5 42.0 Breads/rolls, not 0.37 0.19 18.7 8.0 (21 CFR § 136.130) d white 3 Raisin bread, rolls, and buns 192 1 42.0 36.8 Breads/rolls, white 0.43 0.22 18.1 8.1 (21 CFR § 136.160) 4 Whole wheat bread, rolls, 1,906 14 57.3 51.7 Breads/rolls, not 0.37 0.19 21.2 9.8 and buns (21 CFR § white 136.180) 5 Potato bread, rolls and buns 140 1 56.7 48.2 Breads/rolls, not 0.37 0.19 21.0 9.2 white 6 Variety breads (rye; 4,129 28 55.5 48.8 Breads/rolls, not 0.37 0.19 20.5 9.3 pumpernickel; whole grain; white 7-12 grain breads/rolls; pulse and vegetable) 7 Biscuits 1,119 8 67.9 56.4 Biscuits 0.08 0.03 5.4 1.7 8 Donuts 871 6 65.0 55.4 Doughnuts/Sweet 0.11 0.05 7.2 2.8 Rolls/Danish/Pop Tarts 9 Cookies 4,899 32 44.5 35.0 Brownies/Cookies 0.20 0.09 8.9 3.2 10 Crackers, crisp (enriched; 507 5 27.1 21.1 Crackers 0.18 0.07 4.9 1.5 whole grain; rye) 11 Croutons and stuffing 518 5 14.8 7.3 Stuffing/dumplings; 0.31 0.16 4.6 1.2 lettuce salads 12 Flat breads (naan/focaccia) 498 3 71.7 58.9 Breads/rolls, white 0.63 0.38 45.2 22.4 and not white e 13 Tortillas (flour and corn) 4,089 28 74.8 58.0 Tortillas/Tacos 0.16 0.06 12.0 3.5 14 Breading (Panko type used 2,829 18 13.9 9.5 Tuna; Ground Beef 0.46 0.31 6.4 2.9

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Amount Consumed per Eating Occasion a Frequency of Consumption b Usual Intake c Arithmetic Geometric Arithmetic Geometric Arithmetic Geometric % Mean Mean Mean Mean Mean Mean Food Categories N* User - - - g/EO - - - FFQ Food - - - EO/day ------g/ day - - - in further processing) in Mixtures; Chicken salads/mixtures; Chicken (not in a salad/mixtures); Fried Fish/Fish sticks 15 Ice cream inclusions (wafers, 512 3 6.6 5.8 Ice Cream/Ice 0.17 0.08 1.1 0.5 cones, broken cookie pieces Cream or crumbs) f Bars/Sherbet 16 Baby f ood: teething 75 0.2 14.3 8.3 NA NA NA NA NA crackers/biscuits a Based on 24-hour dietary recall from NHANES 2011-2014. b Based on NHANES 2003-2006 Food Frequency Questionnaire. c Calculated as amount per eating occasion (g/EO) X frequency of consumption (EO/day). d Milk breads not reported consumed, therefore, NHANES bread codes that do not specify the main flour type was used as a surrogate to derive intake estimates. e FFQ food for white and not white breads/roll mapped to the category of flat breads because flat bread NHANES codes included regular, wheat, and whole wheat varieties. f Intake estimates based on NHANES codes for ice cream cones (i.e., cake or wafer-type, sugar rolled-type) and its component ice cream desserts. Unable to capture cookie pieces or crumbs as NHANES does not have a code specific to ice cream inclusion and does not provide information on cookie pieces or crumbs on ice cream and frozen dairy desserts. * Unweighted number of users; %user and mean estimates derived using the statistical weights provided by the NCHS. NA: Frequency of consumption and usual intake estimates not available because the frequency of consumption of baby foods is not collected in the NHANES FFQ.

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References

National Center for Health Statistics (NCHS). 2016. National Health and Nutrition Examination Survey Data 2013-2014. Hyattsville, MD: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention. Available via: http://wwwn.cdc.gov/Nchs/Nhanes/Search/Nhanes13_14.aspx.

National Center for Health Statistics (NCHS). 2014. National Health and Nutrition Examination Survey Data 2011-2012. Hyattsville, MD: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention. Available via: http://wwwn.cdc.gov/Nchs/Nhanes/Search/Nhanes11_12.aspx .

National Center for Health Statistics (NCHS). 2008. National Health and Nutrition Examination Survey Data 2005-2006; Food Frequency Questionnaire – Output from DietCalc Software. Hyattsville, MD: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention. Available via: http://wwwn.cdc.gov/Nchs/Nhanes/Search/Nhanes05_06.aspx .

National Center for Health Statistics (NCHS). 2007. National Health and Nutrition Examination Survey Data 2003-2004; Food Frequency Questionnaire – Output from DietCalc Software. Hyattsville, MD: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention. Available via: http://wwwn.cdc.gov/nchs/nhanes/search/nhanes03_04.aspx .

U.S. Department of Agriculture (USDA). 2017. Food Patterns Equivalents Database 2013-14: Methodology and User Guide. Beltsville, MD: US Department of Agriculture, Agricultural Research Service, Food Surveys Research Group. Available via: https://www.ars.usda.gov/northeast-area/beltsville-md/beltsville-human-nutrition-research- center/food-surveys-research-group/docs/fped-databases/ .

U.S. Department of Agriculture (USDA). 2016a. USDA Food and Nutrient Database for Dietary Studies (FNDDS), 2013-2014. Beltsville, MD: US Department of Agriculture, Agricultural

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Research Service, Food Surveys Research Group. Available via: http://www.ars.usda.gov/ba/bhnrc/fsrg .

U.S. Department of Agriculture, Agricultural Research Service. 2016b. Table 1 – Nutrient Intakes from Food and Beverages: Mean Amounts Consumed per Individual, by Gender and Age, in the United States, 2013-2014. Available at: https://www.ars.usda.gov/ARSUserFiles/80400530/pdf/1314/Table_1_NIN_GEN_13.pdf

U.S. Department of Agriculture (USDA). 2014a. USDA Food and Nutrient Database for Dietary Studies (FNDDS), 2011-2012. Beltsville, MD: US Department of Agriculture, Agricultural Research Service, Food Surveys Research Group. Available via: http://www.ars.usda.gov/ba/bhnrc/fsrg .

U.S. Department of Agriculture (USDA). 2014b. Food Patterns Equivalents Database 2011-12: Methodology and User Guide. Beltsville, MD: US Department of Agriculture, Agricultural Research Service, Food Surveys Research Group. Available via: https://www.ars.usda.gov/northeast-area/beltsville-md/beltsville-human-nutrition-research- center/food-surveys-research-group/docs/fped-databases/ .

U.S. Department of Agriculture (USDA). 2014c. Table 1 – Nutrient Intakes from Food and Beverages: Mean Amounts Consumed per Individual, by Gender and Age, in the United States, 2011-2012. Available at: https://www.ars.usda.gov/ARSUserFiles/80400530/pdf/1112/Table_1_NIN_GEN_11.pdf .

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Appendix I. Food Codes Included In Analysis

Food Category Food code Food description 1 Enriched bread, rolls, and 13210110 Pudding, bread* buns (21 CFR § 136.115) 14640000 Cheese sandwich* 14640100 Cheese sandwich, grilled* 27214100 Meat loaf made with beef* 27214110 Meat loaf made with beef, with tomato -based sauce* 27235000 Meat loaf made with venison/deer* 27246500 Meat loaf made with chicken or turkey* 27246505 Meat loaf made with chicken or turkey, with tomato -based sauce* 27250150 Tuna loaf* 27250250 Flounder with crab stuffing* 27250450 Shrimp toast, fried* 27260010 Meat loaf, NS as to type of meat* 27260050 Meatballs, with breading, NS as to type of meat, with gravy* 27260080 Meat loaf made with beef and pork* 27260090 Meat loaf made with beef, veal and pork* 27260100 Meat loaf made with beef and pork, with tomato -based sauce* 27260510 Liver dumpling* 27351020 Codfish salad, Puerto Rican style (Gazpacho de bacalao)* 27500050 Sandwich, NFS* 27510110 Beef barbecue sandwich or Sloppy Joe, on bun* 27510210 Cheeseburger, plain, on bun* 27510220 Cheeseburger, with mayonnaise or salad dressing, on bun* 27510230 Cheeseburger, with mayonnaise or salad dressing, and tomato and/or catsup, on bun* 27510250 Cheeseburger, 1/4 lb meat, with mayonnaise or salad dressing, on bun* 27510260 Cheeseburger, 1/4 lb meat, with mushrooms in sauce, on bun* 27510265 Double cheeseburger, (2 patties, 1 oz each), plain, on miniature bun* 27510280 Double cheeseburger (2 patties), with mayonnaise or salad dressing, on bun* 27510300 Double cheeseburger (2 patties), with mayonnaise or salad dressing, on double-decker bun* 27510310 Cheeseburger with tomato and/or catsup, on bun* 27510311 Cheeseburger, 1 oz meat, plain, on miniature bun* 27510320 Cheeseburger, 1/4 lb meat, with tomato and/or catsup, on bun* 27510330 Double cheeseburger (2 patties), with tomato and/or catsup, on bun* 27510340 Double cheeseburger (2 patties), with mayonnaise or salad dressing and tomatoes and/or catsup, on bun* 27510350 Cheeseburger, 1/4 lb meat, with mayonnaise or salad

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Food Category Food code Food description dressing, and tomato and/or catsup, on bun* 27510355 Cheeseburger, 1/3 lb meat, with mayonnaise or salad dressing, tomato and/or catsup on bun* 27510359 Cheeseburger, 1/3 lb meat, with mayonnaise or salad dressing, and mushrooms, on bun* 27510360 Bacon cheeseburger, with mayonnaise or salad dressing, tomato and/or catsup, on bun* 27510370 Double cheeseburger (2 patties, 1/4 lb meat each), with mayonnaise or salad dressing, on bun* 27510375 Double cheeseburger (2 patties, 1/4 lb meat each), with tomato and/or catsup, on bun* 27510380 Triple cheeseburger (3 patties, 1/4 lb meat each), with mayonnaise or salad dressing and tomatoes and/or catsup, on bun* 27510385 Double bacon cheeseburger (2 patties), with tomato and/or catsup, on bun* 27510400 Bacon cheeseburger, 1/4 lb meat, with tomato and/or catsup, on bun* 27510410 Chiliburger, on bun* 27510425 Double bacon cheeseburger (2 patties, 1/4 lb meat each), with mayonnaise or salad dressing, on bun* 27510430 Double bacon cheeseburger (2 patties, 1/4 lb meat each), with mayonnaise or salad dressing, and tomato and/or catsup, on bun* 27510435 Double bacon cheeseburger (2 patties,1/3 lb meat each), with mayonnaise or salad dressing, on bun* 27510440 Bacon cheeseburger, 1/4 lb meat, with mayonnaise or salad dressing, and tomato and/or catsup, on bun* 27510445 Bacon cheeseburger, 1/3 lb meat, with tomato and/or catsup, on bun* 27510500 Hamburger, plain, on bun* 27510510 Hamburger, with tomato and/or catsup, on bun* 27510520 Hamburger, with mayonnaise or salad dressing, and tomato and/or catsup, on bun* 27510540 Double hamburger (2 patties), with tomato and/or catsup, on bun* 27510560 Hamburger, 1/4 lb meat, with mayonnaise or salad dressing, and tomato and/or catsup, on bun* 27510570 Hamburger, 2 -1/2 oz meat, with mayonnaise or salad dressing and tomatoes, on bun* 27510600 Hamburger, 1 oz meat, plain, on miniature bun* 27510620 Hamburger, 1/4 lb meat, with tomato and/or catsup, on bun* 27510670 Double hamburger (2 patties), with mayonnaise or salad dressing and tomatoes, on bun* 27510680 Double hamburger (2 patties, 1/4 lb meat each), with tomato and/or catsup, on bun* 27510690 Double hamburger (2 patties, 1/4 lb meat each), with mayonnaise or salad dressing and tomatoes and/or catsup, on double-decker bun*

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Food Category Food code Food description 27510700 Meatball and spaghetti sauce submarine sandwich* 27511010 Pastrami sandwich* 27513010 Roast beef sandwich* 27513040 Roast beef submarine sandwich, with lettuce, tomato and spread* 27513041 Roast beef submarine sandwich, with cheese, lettuce, tomato and spread* 27513050 Roast beef sandwich with cheese* 27513060 Roast beef sandwich with bacon and cheese sauce* 27513070 Roast beef submarine sandwich, on roll, au jus* 27515010 Steak sandwich, plain, on roll* 27515020 Steak and cheese submarine sandwich, with lettuce and tomato* 27515030 Steak and cheese sandwich, plain, on roll* 27515040 Steak and cheese submarine sandwich, plain, on roll* 27515070 Steak and cheese submarine sandwich, with fried peppers and onions, on roll* 27520130 Bacon, chicken, and tomato club sandwich, with lettuce and spread* 27520135 Bacon, chicken, and tomato club sandwich, with cheese, lettuce and spread* 27520140 Bacon and egg sandwich* 27520150 Bacon, lettuce, and tomato sandwich with spread* 27520155 Bacon, lettuce, and tomato submarine sandwich, with spread* 27520156 Bacon, lettuce, tomato, and cheese submarine sandwich, with spread* 27520166 Bacon, chicken fillet (breaded, fried), and tomato club sandwich with cheese, lettuce and spread* 27520300 Ham sandwich, with spread* 27520320 Ham and cheese sandwich, with lettuce and spread* 27520330 Ham and egg sandwich* 27520370 Hot ham and cheese sandwich, on bun* 27520390 Ham and cheese submarine sandwich, with lettuce, tomato and spread* 27520500 Pork sandwich, on white roll, with onions, dill pickles and barbecue sauce* 27520510 Pork barbecue sandwich or Sloppy Joe, on bun* 27520520 Pork sandwich* 27540110 Chicken sandwich, with spread* 27540111 Chicken sandwich, with cheese and spread* 27540120 Chicken salad or chicken spread sandwich* 27540130 Chicken barbecue sandwich* 27540140 Chicken fillet (breaded, fried) sandwich* 27540150 Chicken fillet (breaded, fried) sandwich with lettuce, tomato and spread* 27540151 Chicken fillet (breaded, fried) sandwich with cheese, lettuce, tomato and spread* 27540170 Chicken patty sandwich, miniature, with spread*

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Food Category Food code Food description 27540190 Chicken patty sandwich, with lettuce and spread* 27540235 Chicken fillet, broiled, sandwich with lettuce, tomato, and spread* 27540270 Chicken fillet, broiled, sandwich, with lettuce, tomato, and non - mayonnaise type spread* 27540280 Chicken fillet, broiled, sandwich with cheese, on bun, with lettuce, tomato and spread* 27540290 Chicken submarine sandwich, with lettuce, tomato, and spread* 27540291 Chicken submarine sandwich, with cheese, lettuce, tomato, and spread* 27540310 Turkey sandwich, with spread* 27540350 Turkey submarine sandwich, with cheese, lettuce, tomato and spread* 27541000 Turkey, ham, and roast beef club sandwich, with lettuce, tomato and spread* 27541001 Turkey, ham, and roast beef club sandwich with cheese, lettuce, tomato, and spread* 27550000 Fish sandwich, on bun, with spread* 27550100 Fish sandwich, on bun, with cheese and spread* 27550720 Tuna salad sandwich* 27550750 Tuna salad submarine sandwich, with lettuce and tomato* 27550751 Tuna salad submarine sandwich, with cheese, lettuce and tomato* 27560350 Pig in a blanket (frankfurter or hot dog wrapped in dough)* 27560500 Pepperoni and salami submarine sandwich, with lettuce, tomato, and spread* 27560710 Sausage sandwich* 27560910 Cold cut submarine sandwich, with cheese, lettuce, tomato, and spread* 27564000 Frankfurter or hot dog sandwich, NFS, plain, on white bun* 27564010 Frankfurter or hot dog sandwich, NFS, plain, on white bread* 27564060 Frankfurter or hot dog sandwich, beef, plain, on white bun* 27564070 Frankfurter or hot dog sandwich, beef, plain, on white bread* 27564120 Frankfurter or hot dog sandwich, beef and pork, plain, on white bun* 27564130 Frankfurter or hot dog sandwich, beef and pork, plain, on white bread* 27564180 Frankfurter or hot dog sandwich, meat and poultry, plain, on white bun* 27564190 Frankfurter or hot dog sandwich, meat and poultry, plain, on white bread* 27564240 Frankfurter or hot dog sandwich, chicken and/or turkey, plain, on white bun* 27564250 Frankfurter or hot dog sandwich, chicken and/or turkey, plain, on white bread* 27564300 Frankfurter or hot dog sandwich, reduced fat or light, plain, on white bun* 27564310 Frankfurter or hot dog sandwich, reduced fat or light, plain, on

1708708.000 – 7281 25 Center for Chemical Regulation and Food Safety

Food Category Food code Food description white bread* 27564360 Frankfurter or hot dog sandwich, fat free, plain, on white bun* 27564370 Frankfurter or hot dog sandwich, fat free, plain, on white bread* 27564420 Frankfurter or hot dog sandwich, meatless, plain, on bun* 27564430 Frankfurter or hot dog sandwich, meatless, plain, on bread* 27564440 Frankfurter or hot dog sandwich, with chili, on white bun* 27564450 Frankfurter or hot dog sandwich, with chili, on white bread* 27564500 Frankfurter or hot dog sandwich, with meatless chili, on white bun* 27564510 Frankfurter or hot dog sandwich, with meatless chili, on white bread* 27570310 Hors d'oeuvres, with spread* 28145100 Turkey with dressing, gravy, vegetable and fruit (diet frozen meal)* 32201000 Fried egg sandwich* 32202000 Egg, cheese, ham, and bacon on bun* 32202035 Egg, extra cheese (2 slices), and extra sausage (2 patties) on bun* 41901020 Soyburger, meatless, with cheese on bun* 42301010 Peanut butter sandwich* 42302010 Peanut butter and jelly sandwich* 51000100 Bread, NS as to major flour 51000110 Bread, NS as to major flour, toasted 51000180 Bread, made from home recipe or purchased at a bakery, NS as to major flour 51000190 Bread, made from home recipe or purchased at a bakery, toasted, NS as to major flour 51000200 Roll, NS as to major flour 51000300 Roll, hard, NS as to major flour 51101000 Bread, white 51101010 Bread, white, toasted 51101050 Bread, white, made from home recipe or purchased at a bakery 51101060 Bread, white, made from home recipe or purchased at a bakery, toasted 51105010 Bread, Cuban 51105040 Bread, Cuban, toasted 51107010 Bread, French or Vienna 51107040 Bread, French or Vienna, toasted 51109010 Bread, Italian, Grecian, Armenian 51109040 Bread, Italian, Grecian, Armenian, toasted 51113100 Bread, cinnamon, toasted 51122000 Bread, reduced calorie and/or high fiber, white or NFS 51122010 Bread, reduced calorie and/or high fiber, white or NFS, toasted 51140100 Bread, dough, fried* 51150000 Roll, white, soft

1708708.000 – 7281 26 Center for Chemical Regulation and Food Safety

Food Category Food code Food description 51150100 Roll, white, soft, toasted 51151060 Roll, white, soft, made from home recipe or purchased at a bakery 51153000 Roll, white, hard 51154010 Roll, white, hot dog bun 51154100 Roll, white, hamburger bun 51154600 Roll, cheese* 51157000 Roll, white, hoagie, submarine 53415100 Crisp, apple, apple dessert* 55301000 French toast, plain* 58127500 Vegetable submarine sandwich, with fat free spread* 2 Milk bread, rolls, and buns 51000100 Bread, NS as to major flour (21 CFR § 136.130) 51000110 Bread, NS as to major flour, toasted 51000180 Bread, made from home recipe or purchased at a bakery, NS as to major flour 51000190 Bread, made from home recipe or purchased at a bakery, toasted, NS as to major flour 51000200 Roll, NS as to major flour 51000300 Roll, hard, NS as to major flour 3 Raisin bread, rolls, and buns 51000100 Bread, NS as to major flour (21 CFR § 136.160) 51000110 Bread, NS as to major flour, toasted 51000180 Bread, made from home recipe or purchased at a bakery, NS as to major flour 51000190 Bread, made from home recipe or purchased at a bakery, toasted, NS as to major flour 51000200 Roll, NS as to major flour 51000300 Roll, hard, NS as to major flour 51129010 Bread, raisin 51129020 Bread, raisin, toasted 4 Whole wheat bread, rolls, and 27540230 Chicken patty sandwich with cheese, on wheat bun, with buns (21 CFR § 136.180) lettuce, tomato and spread* 27540240 Chicken fillet, (broiled), sandwich, on whole wheat roll, with lettuce, tomato and spread* 27540250 Chicken fillet, broiled, sandwich with cheese, on whole wheat roll, with lettuce, tomato and non-mayonnaise type spread* 27564062 Frankfurter or hot dog sandwich, beef, plain, on whole wheat bun* 27564090 Frankfurter or hot dog sandwich, beef, plain, on whole wheat bread* 27564150 Frankfurter or hot dog sandwich, beef and pork, plain, on whole wheat bread* 27564182 Frankfurter or hot dog sandwich, meat and poultry, plain, on whole wheat bun* 27564210 Frankfurter or hot dog sandwich, meat and poultry, plain, on whole wheat bread* 27564242 Frankfurter or hot dog sandwich, chicken and/or turkey, plain,

1708708.000 – 7281 27 Center for Chemical Regulation and Food Safety

Food Category Food code Food description on whole wheat bun* 27564270 Frankfurter or hot dog sandwich, chicken and/or turkey, plain, on whole wheat bread* 27564362 Frankfurter or hot dog sandwich, fat free, plain, on whole wheat bun* 27564442 Frankfurter or hot dog sandwich, with chili, on whole wheat bun* 51000100 Bread, NS as to major flour 51000110 Bread, NS as to major flour, toasted 51000180 Bread, made from home recipe or purchased at a bakery, NS as to major flour 51000190 Bread, made from home recipe or purchased at a bakery, toasted, NS as to major flour 51000200 Roll, NS as to major flour 51000300 Roll, hard, NS as to major flour 51201010 Bread, whole wheat, 100% 51201020 Bread, whole wheat, 100%, toasted 51201060 Bread, whole wheat, 100%, made from home recipe or purchased at bakery 51201070 Bread, whole wheat, 100%, made from home recipe or purchased at bakery, toasted 51300110 Bread, whole wheat 51300120 Bread, whole wheat, toasted 51300140 Bread, whole wheat, made from home recipe or purchased at bakery 51300150 Bread, whole wheat, made from home recipe or purchased at bakery, toasted 51300210 Bread, whole wheat, with raisins 51300220 Bread, whole wheat, with raisins, toasted 51301540 Bread, French or Vienna, whole wheat 51320500 Roll, whole wheat 51320550 Roll, whole wheat, hot dog bun 51320560 Roll, whole wheat, hamburger bun 5 Potato Bread, rolls and buns 51000100 Bread, NS as to major flour 51000110 Bread, NS as to major flour, toasted 51000180 Bread, made from home recipe or purchased at a bakery, NS as to major flour 51000190 Bread, made from home recipe or purchased at a bakery, toasted, NS as to major flour 51000200 Roll, NS as to major flour 51000300 Roll, hard, NS as to major flour 51127010 Bread, potato 51127020 Bread, potato, toasted 6 Variety breads (rye; 27510480 Cheeseburger (hamburger with cheese sauce), 1/4 lb meat, pumpernickel; whole grain; 7- with grilled onions, on rye bun* 12 grain breads/rolls; pulse and vegetable) 27510950 Reuben sandwich (corned beef sandwich with sauerkraut and

1708708.000 – 7281 28 Center for Chemical Regulation and Food Safety

Food Category Food code Food description cheese), with spread* 27520165 Bacon, chicken fillet (breaded, fried), and tomato club with lettuce and spread* 27564001 Frankfurter or hot dog sandwich, NFS, plain, on wheat bun* 27564020 Frankfurter or hot dog sandwich, NFS, plain, on wheat bread* 27564061 Frankfurter or hot dog sandwich, beef, plain, on wheat bun* 27564063 Frankfurter or hot dog sandwich, beef, plain, on whole grain white bun* 27564064 Frankfurter or hot dog sandwich, beef, plain, on multigrain bun* 27564080 Frankfurter or hot dog sandwich, beef, plain, on wheat bread* 27564100 Frankfurter or hot dog sandwich, beef, plain, on whole grain white bread* 27564121 Frankfurter or hot dog sandwich, beef and pork, plain, on wheat bun* 27564140 Frankfurter or hot dog sandwich, beef and pork, plain, on wheat bread* 27564160 Frankfurter or hot dog sandwich, beef and pork, plain, on whole grain white bread* 27564181 Frankfurter or hot dog sandwich, meat and poultry, plain, on wheat bun* 27564200 Frankfurter or hot dog sandwich, meat and poultry, plain, on wheat bread* 27564220 Frankfurter or hot dog sandwich, meat and poultry, plain, on whole grain white bread* 27564230 Frankfurter or hot dog sandwich, meat and poultry, plain, on multigrain bread* 27564241 Frankfurter or hot dog sandwich, chicken and/or turkey, plain, on wheat bun* 27564260 Frankfurter or hot dog sandwich, chicken and/or turkey, plain, on wheat bread* 27564280 Frankfurter or hot dog sandwich, chicken and/or turkey, plain, on whole grain white bread* 27564303 Frankfurter or hot dog sandwich, reduced fat or light, plain, on whole grain white bun* 27564361 Frankfurter or hot dog sandwich, fat free, plain, on wheat bun* 27564364 Frankfurter or hot dog sandwich, fat free, plain, on multigrain bun* 27564443 Frankfurter or hot dog sandwich, with chili, on whole grain white bun* 27564460 Frankfurter or hot dog sandwich, with chili, on wheat bread* 51000100 Bread, NS as to major flour 51000110 Bread, NS as to major flour, toasted 51000180 Bread, made from home recipe or purchased at a bakery, NS as to major flour 51000190 Bread, made from home recipe or purchased at a bakery, toasted, NS as to major flour 51000200 Roll, NS as to major flour 51000300 Roll, hard, NS as to major flour

1708708.000 – 7281 29 Center for Chemical Regulation and Food Safety

Food Category Food code Food description 51000400 Roll, bran, NS as to type of bran 51102010 Bread, white with whole wheat swirl 51102020 Bread, white with whole wheat swirl, toasted 51121010 Bread, garlic 51121110 Bread, onion 51123010 Bread, high protein 51134000 Bread, sweet potato 51135000 Bread, vegetable 51135010 Bread, vegetable, toasted 51156500 Roll, garlic 51207010 Bread, sprouted wheat 51207020 Bread, sprouted wheat, toasted 51300050 Bread, whole grain white 51300060 Bread, whole grain white, toasted 51300180 Bread, puri or poori (Indian puffed bread), wheat 51300300 Bread, sprouted wheat 51300310 Bread, sprouted wheat, toasted 51301010 Bread, wheat or cracked wheat 51301020 Bread, wheat or cracked wheat, toasted 51301040 Bread, wheat or cracked wheat, made from home recipe or purchased at bakery 51301050 Bread, wheat or cracked wheat, made from home recipe or purchased at bakery, toasted 51301120 Bread, wheat or cracked wheat, with raisins 51301130 Bread, wheat or cracked wheat, with raisins, toasted 51301510 Bread, wheat or cracked wheat, reduced calorie and/or high fiber 51301520 Bread, wheat or cracked wheat, reduced calorie and/or high fiber, toasted 51320010 Roll, wheat or cracked wheat 51320040 Roll, wheat or cracked wheat, made from home recipe or purchased at bakery 51320060 Roll, wheat or cracked wheat, hot dog bun 51320070 Roll, wheat or cracked wheat, hamburger bun 51320700 Roll, whole grain white 51320710 Roll, whole grain white, hot dog bun 51320720 Roll, whole grain white, hamburger bun 51401010 Bread, rye 51401020 Bread, rye, toasted 51401030 Bread, marble rye and pumpernickel 51401040 Bread, marble rye and pumpernickel, toasted 51404010 Bread, pumpernickel 51404020 Bread, pumpernickel, toasted 51407010 Bread, black 51407020 Bread, black, toasted 51420000 Roll, rye 51421000 Roll, pumpernickel 51501010 Bread, oatmeal

1708708.000 – 7281 30 Center for Chemical Regulation and Food Safety

Food Category Food code Food description 51501020 Bread, oatmeal, toasted 51501040 Bread, oat bran 51501050 Bread, oat bran, toasted 51502010 Roll, oatmeal 51601010 Bread, multigrain, toasted 51601020 Bread, multigrain 51601210 Bread, multigrain, with raisins 51602010 Bread, multigrain, reduced calorie and/or high fiber 51620000 Roll, multigrain 51620020 Roll, multigrain, hot dog bun 51620030 Roll, multigrain, hamburger bun 51805010 Bread, sunflower meal 7 Biscuits 27515080 Steak sandwich, plain, on biscuit* 27520170 Bacon on biscuit* 27520250 Ham on biscuit* 27540145 Chicken fillet (breaded, fried) sandwich on biscuit* 27540180 Chicken patty sandwich or biscuit* 27560650 Sausage on biscuit* 27560705 Sausage balls (made with biscuit mix and cheese) 32202020 Egg, cheese, and ham on biscuit* 32202050 Egg, cheese, and sausage on biscuit* 32202060 Egg and sausage on biscuit* 32202070 Egg, cheese, and bacon on biscuit* 32202090 Egg and bacon on biscuit* 32202110 Egg and ham on biscuit* 32202130 Egg and steak on biscuit* 32202200 Egg and cheese on biscuit* 52101000 Biscuit, baking powder or buttermilk type, NS as to made from mix, refrigerated dough, or home recipe 52101030 Biscuit dough, fried 52101100 Biscuit, baking powder or buttermilk type, made from mix 52102040 Biscuit, baking powder or buttermilk type, made from refrigerated dough 52103000 Biscuit, baking powder or buttermilk type, commercially baked 52104010 Biscuit, baking powder or buttermilk type, made from home recipe 52104040 Biscuit, whole wheat 52104100 Biscuit, cheese* 52104200 Biscuit, cinnamon -raisin 58128000 Biscuit with gravy* 8 Donuts 53520000 Doughnut, NS as to cake or yeast 53520110 Doughnut, cake type 53520120 Doughnut, chocolate, cake type 53520140 Doughnut, cake type, chocolate covered 53520150 Doughnut, cake type, chocolate covered, dipped in peanuts 53520160 Doughnut, chocolate, cake type, with chocolate icing 53521100 Doughnut, chocolate, raised or yeast, with chocolate icing 53521110 Doughnut, raised or yeast

1708708.000 – 7281 31 Center for Chemical Regulation and Food Safety

Food Category Food code Food description 53521120 Doughnut, chocolate, raised or yeast 53521130 Doughnut, raised or yeast, chocolate covered 53521140 Doughnut, jelly 53521210 Doughnut, custard -filled 53521230 Doughnut, custard -filled, with icing 9 Cookies 53201000 Cookie, NFS 53202000 Cookie, almond 53203500 Cookie, biscotti (Italian sugar cookie) 53205260 Cookie, bar, with chocolate 53206000 Cookie, chocolate chip 53206020 Cookie, chocolate chip, made from home recipe or purchased at a bakery 53206030 Cookie, chocolate chip, reduced fat 53206100 Cookie, chocolate chip sandwich 53206500 Cookie, chocolate, made with rice cereal 53206550 Cookie, chocolate, made with oatmeal and coconut (no -bake) 53207000 Cookie, chocolate or fudge 53207020 Cookie, chocolate or fudge, reduced fat 53207050 Cookie, chocolate, with chocolate filling or coating, fat free 53208000 Cookie, marshmallow, chocolate -covered 53208200 Cookie, marshmallow pie, chocolate covered 53209005 Cookie, chocolate, with icing or coating 53209010 Cookie, sugar wafer, chocolate -covered 53209015 Cookie, chocolate sandwich 53209020 Cookie, chocolate sandwich, reduced fat 53209100 Cookie, chocolate, sandwich, with extra filling 53209500 Cookie, chocolate and vanilla sandwich 53210000 Cookie, chocolate wafer 53210900 Cookie, graham cracker with chocolate and marshmallow 53211000 Cookie bar, with chocolate, nuts, and graham crackers 53215500 Cookie, coconut 53220000 Cookie, fruit -filled bar 53220010 Cookie, fruit -filled bar, fat free 53220030 Cookie, fig bar 53220040 Cookie, fig bar, fat free 53222010 Cookie, fortune 53223000 Cookie, gingersnaps 53223100 Cookie, granola 53224000 Cookie, ladyfinger 53224250 Cookie, lemon bar 53225000 Cookie, macaroon 53226000 Cookie, marshmallow, with coconut 53226500 Cookie, marshmallow, with rice cereal (no -bake) 53226550 Cookie, marshmallow, with rice cereal and chocolate chips 53228000 Cookie, meringue 53230000 Cookie, molasses 53231000 Cookie, Lebkuchen 53231400 Cookie, multigrain, high fiber

1708708.000 – 7281 32 Center for Chemical Regulation and Food Safety

Food Category Food code Food description 53233000 Cookie, oatmeal 53233010 Cookie, oatmeal, with raisins 53233040 Cookie, oatmeal, reduced fat, NS as to raisins 53233050 Cookie, oatmeal sandwich, with creme filling 53233060 Cookie, oatmeal, with chocolate chips 53233080 Cookie, oatmeal sandwich, with peanut butter and jelly filling 53233100 Cookie, oatmeal, with chocolate and peanut butter (no -bake) 53234000 Cookie, peanut butter 53234100 Cookie, peanut butter, with chocolate 53234250 Cookie, peanut butter with rice cereal (no -bake) 53235000 Cookie, peanut butter sandwich 53235500 Cookie, with peanut butter filling, chocolate -coated 53235600 Cookie, Pfeffernusse 53236100 Cookie, pumpkin 53237000 Cookie, raisin 53237010 Cookie, raisin sandwich, cream -filled 53238000 Cookie, sandwich -type, not chocolate or vanilla 53239000 Cookie, shortbread 53239010 Cookie, shortbread, reduced fat 53239050 Cookie, shortbread, with icing or filling 53240000 Cookie, animal 53240010 Cookie, animal, with frosting or icing 53241500 Cookie, butter or sugar 53241510 Marie biscuit 53241600 Cookie, butter or sugar, with fruit and/or nuts 53242000 Cookie, sugar wafer 53242500 Cookie, toffee bar 53243000 Cookie, vanilla sandwich 53243010 Cookie, vanilla sandwich, extra filling 53243050 Cookie, vanilla sandwich, reduced fat 53244010 Cookie, butter or sugar, with chocolate icing or filling 53244020 Cookie, butter or sugar, with icing or filling other than chocolate 53246000 Cookie, tea, Japanese 53247000 Cookie, vanilla wafer 53247050 Cookie, vanilla wafer, reduced fat 53247500 Cookie, vanilla with caramel, coconut, and chocolate coating 53251100 Cookie, rugelach 53260030 Cookie, chocolate chip, sugar free 53260200 Cookie, oatmeal, sugar free 53260300 Cookie, sandwich, sugar free 53260400 Cookie, sugar or plain, sugar free 53260500 Cookie, sugar wafer, sugar free 53260600 Cookie, peanut butter, sugar free 53261000 Cookie, gluten free 53270100 Cookies, Puerto Rican (Mantecaditos polvorones) 10 Crackers, crisp (enriched; 51187000 Melba toast whole grain; rye)

1708708.000 – 7281 33 Center for Chemical Regulation and Food Safety

Food Category Food code Food description 51188500 Zwieback toast 54001000 Crackers, NS as to sweet or nonsweet 54203010 Crackers, toast thins (rye, wheat, white flour), low sodium 54204010 Cracker, 100% whole wheat, low sodium 54304500 Cracker, high fiber, no added fat 54305000 Crispbread, wheat, no added fat 54322000 Crispbread, rye, no added fat 54334000 Crackers, toast thins (rye, pumpernickel, white flour) 54337000 Cracker, 100% whole wheat 54337050 Cracker, 100% whole wheat, reduced fat 54338000 Crackers, wheat 54338100 Crackers, wheat, reduced fat 11 Croutons and stuffing 27220050 Ham or pork with stuffing (mixture)* 27246200 Chicken or turkey with stuffing (mixture)* 28145110 Turkey with vegetable, stuffing (diet frozen meal)* 28145210 Turkey with gravy, dressing, potatoes, vegetable (frozen meal)* 28145610 Turkey with gravy, dressing, potatoes, vegetable, dessert (frozen meal, large meat portion)* 51182010 Bread stuffing* 51182020 Bread stuffing made with egg* 51185000 Croutons 52204000 Cornbread stuffing* 58128120 Cornmeal dressing with chicken or turkey and vegetables* 58128210 Dressing with oysters* 58128220 Dressing with chicken or turkey and vegetables* 58128250 Dressing with meat and vegetables* 72116150 Caesar salad (with romaine), no dressing* 12 Flat breads (naan/focaccia) 27515050 Fajita -style beef sandwich with cheese, on pita bread, with lettuce and tomato* 27516010 Gyro sandwich (pita bread, beef, lamb, onion, condiments), with tomato and spread* 27540200 Fajita -style chicken sandwich with cheese, on pita bread, with lettuce and tomato* 51108010 Focaccia, Italian flatbread, plain 51108100 Naan, Indian flatbread 51109100 Bread, pita 51109110 Bread, pita, toasted 51109150 Bread, pita with fruit 51300175 Bread, chappatti or roti (Indian bread), wheat 51300185 Bread, paratha, (Indian flat bread), wheat 51301600 Bread, pita, whole wheat 51301610 Bread, pita, whole wheat, toasted 51301620 Bread, pita, wheat or cracked wheat 51301630 Bread, pita, wheat or cracked wheat, toasted 51807000 Injera (American -style Ethiopian bread) 13 Tortillas (flour and corn) 27146160 Chicken with mole sauce* 27500200 Wrap sandwich, filled with meat, poultry, or fish, vegetables,

1708708.000 – 7281 34 Center for Chemical Regulation and Food Safety

Food Category Food code Food description and cheese* 27500300 Wrap sandwich, filled with meat, poultry, or fish, and vegetables* 27517000 Wrap sandwich filled with beef patty, cheese and spread and/or sauce* 27517010 Wrap sandwich filled with beef patty, cheese, tomato and/or catsup, and spread and/or sauce* 27540210 Wrap sandwich filled with chicken strips (breaded, fried), cheese, lettuce, and spread* 27540300 Wrap sandwich filled with chicken strips (broiled), cheese, lettuce, and spread* 28522000 Mole poblano (sauce)* 32105180 Huevos rancheros* 52208760 Gordita/sope shell, plain, no filling 52215000 Tortilla, NFS 52215100 Tortilla, corn 52215200 Tortilla, flour (wheat) 52215260 Tortilla, whole wheat 52215300 Taco shell, corn 52215350 Taco shell, flour 53452500 Pastry, mainly flour and water, fried* 58100000 Burrito, taco, or quesadilla with egg* 58100005 Burrito, taco, or quesadilla with egg and potato* 58100010 Burrito, taco, or quesadilla with egg and breakfast meat* 58100013 Burrito, taco, or quesadilla with egg and breakfast meat, from fast food* 58100015 Burrito, taco, or quesadilla with egg, potato, and breakfast meat* 58100017 Burrito, taco, or quesadilla with egg, potato, and breakfast meat, from fast food* 58100020 Burrito, taco, or quesadilla with egg, beans, and breakfast meat* 58100100 Burrito with meat* 58100120 Burrito with meat and beans* 58100125 Burrito with meat and beans, from fast food* 58100135 Burrito with meat and sour cream* 58100140 Burrito with meat, beans, and sour cream* 58100145 Burrito with meat, beans, and sour cream, from fast food* 58100160 Burrito with meat, beans, and rice* 58100165 Burrito with meat, beans, rice, and sour cream* 58100200 Burrito with chicken* 58100220 Burrito with chicken and beans* 58100235 Burrito with chicken and sour cream* 58100245 Burrito with chicken, beans, and sour cream* 58100255 Burrito with chicken, beans, and rice* 58100260 Burrito with chicken, beans, rice, and sour cream* 58100300 Burrito with beans and rice, meatless* 58100320 Burrito with beans, meatless*

1708708.000 – 7281 35 Center for Chemical Regulation and Food Safety

Food Category Food code Food description 58100325 Burrito with beans, meatless, from fast food* 58100330 Burrito with beans, rice, and sour cream, meatless* 58100360 Chilaquiles, tortilla casserole with salsa, cheese, and egg* 58100370 Chilaquiles, tortilla casserole with salsa and cheese, no egg* 58100520 Enchilada with meat and beans, red -chile or enchilada sauce* 58100525 Enchilada with meat and beans, green -chile or enchilada sauce* 58100530 Enchilada with meat, red -chile or enchilada sauce* 58100535 Enchilada with meat, green -chile or enchilada sauce* 58100620 Enchilada with chicken and beans, red -chile or enchilada sauce* 58100625 Enchilada with chicken and beans, green -chile or enchilada sauce* 58100630 Enchilada with chicken, red -chile or enchilada sauce* 58100635 Enchilada with chicken, green -chile or enchilada sauce* 58100720 Enchilada with beans, meatless, red -chile or enchilada sauce* 58100725 Enchilada with beans, green -chile or enchilada sauce* 58100800 Enchilada, just cheese, meatless, no beans, red -chile or enchilada sauce* 58100805 Enchilada, just cheese, meatless, no beans, green -chile or enchilada sauce* 58101320 Taco or tostada with meat* 58101323 Taco or tostada with meat, from fast food* 58101325 Taco or tostada with meat and sour cream* 58101345 Soft taco with meat* 58101347 Soft taco with meat, from fast food* 58101350 Soft taco with meat and sour cream* 58101357 Soft taco with meat and sour cream, from fast food* 58101450 Soft taco with chicken* 58101457 Soft taco with chicken, from fast food* 58101460 Soft taco with chicken and sour cream* 58101520 Taco or tostada with chicken* 58101525 Taco or tostada with chicken and sour cream* 58101540 Taco or tostada with fish* 58101555 Soft taco with fish* 58101610 Soft taco with beans* 58101615 Soft taco with beans and sour cream* 58101620 Soft taco with meat and beans* 58101625 Soft taco with chicken and beans* 58101630 Soft taco with meat, beans, and sour cream* 58101635 Soft taco with chicken, beans, and sour cream* 58101720 Taco or tostada with beans* 58101725 Taco or tostada with beans and sour cream* 58101730 Taco or tostada with meat and beans* 58101733 Taco or tostada with meat and beans, from fast food* 58101735 Taco or tostada with chicken and beans* 58101745 Taco or tostada with meat, beans, and sour cream* 58101750 Taco or tostada with chicken, beans, and sour cream*

1708708.000 – 7281 36 Center for Chemical Regulation and Food Safety

Food Category Food code Food description 58101800 Ground beef with tomato sauce and taco seasonings on a cornbread crust* 58101820 Mexican casserole made with ground beef, beans, tomato sauce, cheese, taco seasonings, and corn chips* 58101830 Mexican casserole made with ground beef, tomato sauce, cheese, taco seasonings, and corn chips* 58101930 Taco or tostada salad with meat* 58101935 Taco or tostada salad with chicken* 58101940 Taco or tostada salad, meatless* 58101945 Taco or tostada salad with meat and sour cream* 58101950 Taco or tostada salad with chicken and sour cream* 58101955 Taco or tostada salad, meatless with sour cream* 58104260 Gordita, sope, or chalupa with beans* 58104270 Gordita, sope, or chalupa with beans and sour cream* 58104280 Gordita, sope, or chalupa with meat and sour cream* 58104290 Gordita, sope, or chalupa with meat* 58104320 Gordita, sope, or chalupa with chicken and sour cream* 58104340 Gordita, sope, or chalupa with chicken* 58104500 Chimichanga with meat* 58104520 Chimichanga, meatless* 58104530 Chimichanga with chicken* 58104535 Chimichanga with meat and sour cream* 58104550 Chimichanga with chicken and sour cream* 58104710 Quesadilla, just cheese, meatless* 58104720 Quesadilla, just cheese, from fast food* 58104730 Quesadilla with meat* 58104740 Quesadilla with chicken* 58104745 Quesadilla with chicken, from fast food* 58104750 Quesadilla with vegetables* 58104760 Quesadilla with vegetables and meat* 58104770 Quesadilla with vegetables and chicken* 58104800 Taquito or flauta with cheese* 58104820 Taquito or flauta with meat* 58104825 Taquito or flauta with meat and cheese* 58104830 Taquito or flauta with chicken* 58104835 Taquito or flauta with chicken and cheese* 58104905 Taquito or flauta with egg and breakfast meat* 58105000 Fajita with chicken and vegetables* 58105050 Fajita with meat and vegetables* 58105075 Fajita with vegetables* 58200100 Wrap sandwich, filled with meat, poultry, or fish, vegetables, and rice* 58306020 Beef enchilada, chili gravy, rice, refried beans (frozen meal)* 58306070 Cheese enchilada (frozen meal)* 58306100 Chicken enchilada (diet frozen meal)* 58421080 Sopa de tortilla, Mexican style tortilla soup, home recipe* 14 Breading (Panko type used in 21103110 Beef steak, breaded or floured, baked or fried, NS as to fat further processing) eaten*

1708708.000 – 7281 37 Center for Chemical Regulation and Food Safety

Food Category Food code Food description 21103120 Beef steak, breaded or floured, baked or fried, lean and fat eaten* 21103130 Beef steak, breaded or floured, baked or fried, lean only eaten* 21500200 Ground beef or patty, breaded, cooked* 22000300 Pork, NS as to cut, breaded or floured, fried, NS as to fat eaten* 22000310 Pork, NS as to cut, breaded or floured, fried, lean and fat eaten* 22000320 Pork, NS as to cut, breaded or floured, fried, lean only eaten* 22002100 Pork, ground or patty, breaded, cooked* 22101130 Pork chop, breaded or floured, broiled or baked, NS as to fat eaten* 22101140 Pork chop, breaded or floured, broiled or baked, lean and fat eaten* 22101150 Pork chop, breaded or floured, broiled or baked, lean only eaten* 22101300 Pork chop, breaded or floured, fried, NS as to fat eaten* 22101310 Pork chop, breaded or floured, fried, lean and fat eaten* 22101320 Pork chop, breaded or floured, fried, lean only eaten* 22201320 Pork steak or cutlet, breaded or floured, broiled or baked, lean only eaten* 22201410 Pork steak or cutlet, breaded or floured, fried, lean and fat eaten* 22201420 Pork steak or cutlet, breaded or floured, fried, lean only eaten* 22210310 Pork, tenderloin, breaded, fried* 22300160 Ham, breaded or floured, fried, lean and fat eaten* 22300170 Ham, breaded or floured, fried, lean only eaten* 23220030 Veal patty, breaded, cooked* 23321250 Venison/deer steak, breaded or floured, cooked, NS as to cooking method* 24107000 Chicken, NS as to part, coated, baked or fried, prepared with skin, NS as to skin/coating eaten, fat added in cooking* 24107001 Chicken, NS as to part, coated, baked or fried, prepared with skin, NS as to skin/coating eaten, fat not added in cooking* 24107010 Chicken, NS as to part, coated, baked or fried, prepared with skin, skin/coating eaten, fat added in cooking* 24107020 Chicken, NS as to part, coated, baked or fried, prepared with skin, skin/coating not eaten, fat added in cooking* 24107040 Chicken, NS as to part, coated, baked or fried, prepared skinless, NS as to coating eaten, fat added in cooking* 24107050 Chicken, NS as to part, coated, baked or fried, prepared skinless, coating eaten, fat added in cooking* 24127100 Chicken, breast, coated, baked or fried, prepared with skin, NS as to skin/coating eaten, fat added in cooking* 24127110 Chicken, breast, coated, baked or fried, prepared with skin, skin/coating eaten, NS as to type of fat added in cooking* 24127112 Chicken, breast, coated, baked or fried, prepared with skin, skin/coating eaten, made with butter*

1708708.000 – 7281 38 Center for Chemical Regulation and Food Safety

Food Category Food code Food description 24127113 Chicken, breast, coated, baked or fried, prepared with skin, skin/coating eaten, made with oil* 24127115 Chicken, breast, coated, baked or fried, prepared with skin, skin/coating eaten, made without fat* 24127120 Chicken, breast, coated, baked or fried, prepared with skin, skin/coating not eaten, NS as to type of fat added in cooking* 24127140 Chicken, breast, coated, baked or fried, prepared skinless, NS as to coating eaten, fat added in cooking* 24127141 Chicken, breast, coated, baked or fried, prepared skinless, NS as to coating eaten, fat not added in cooking* 24127150 Chicken, breast, coated, baked or fried, prepared skinless, coating eaten, NS as to type of fat added in cooking* 24127151 Chicken, breast, coated, baked or fried, prepared skinless, coating eaten, made with shortening* 24127152 Chicken, breast, coated, baked or fried, prepared skinless, coating eaten, made with butter* 24127153 Chicken, breast, coated, baked or fried, prepared skinless, coating eaten, made with oil* 24127154 Chicken, breast, coated, baked or fried, prepared skinless, coating eaten, made with cooking spray* 24127155 Chicken, breast, coated, baked or fried, prepared skinless, coating eaten, made without fat* 24127160 Chicken, breast, coated, baked or fried, prepared skinless, coating not eaten, NS as to type of fat added in cooking* 24127163 Chicken, breast, coated, baked or fried, prepared skinless, coating not eaten, made with oil* 24127165 Chicken, breast, coated, baked or fried, prepared skinless, coating not eaten, made without fat* 24137210 Chicken, leg (drumstick and thigh), coated, baked or fried, prepared with skin, skin/coating eaten, fat added in cooking* 24137211 Chicken, leg (drumstick and thigh), coated, baked or fried, prepared with skin, skin/coating eaten, fat not added in cooking* 24137220 Chicken, leg (drumstick and thigh), coated, baked or fried, prepared with skin, skin/coating not eaten, fat added in cooking* 24137250 Chicken, leg (dr umstick and thigh), coated, baked or fried, prepared skinless, coating eaten, fat added in cooking* 24137251 Chicken, leg (drumstick and thigh), coated, baked or fried, prepared skinless, coating eaten, fat not added in cooking* 24137260 Chicken, leg (drumstick and thigh), coated, baked or fried, prepared skinless, coating not eaten, fat added in cooking* 24147210 Chicken, drumstick, coated, baked or fried, prepared with skin, skin/coating eaten, NS as to type of fat added in cooking* 24147212 Chicken, drumstick, coated, baked or fried, prepared with skin, skin/coating eaten, made with butter* 24147213 Chicken, drumstick, coated, baked or fried, prepared with skin, skin/coating eaten, made with oil* 24147215 Chicken, drumstick, coated, bak ed or fried, prepared with skin,

1708708.000 – 7281 39 Center for Chemical Regulation and Food Safety

Food Category Food code Food description skin/coating eaten, made without fat* 24147220 Chicken, drumstick, coated, baked or fried, prepared with skin, skin/coating not eaten, NS as to type of fat added in cooking* 24147223 Chicken, drumstick, coated, baked or fried, prepared with skin, skin/coating not eaten, made with oil* 24147240 Chicken, drumstick, coated, baked or fried, prepared skinless, NS as to coating eaten, fat added in cooking* 24147250 Chicken, drumstick, coated, baked or fried, prepared skinless, coating eaten, NS as to type of fat added in cooking* 24147251 Chicken, drumstick, coated, baked or fried, prepared skinless, coating eaten, made with shortening* 24147252 Chicken, drumstick, coated, baked or fried, prepared skinless, coating eaten, made with butter* 24147253 Chicken, drumstick, coated, baked or fried, prepared skinless, coating eaten, made with oil* 24147255 Chicken, drumstick, coated, baked or fried, prepared skinless, coating eaten, made without fat* 24147260 Chicken, drumstick, coated, baked or fried, prepared skinless, coating not eaten, NS as to type of fat added in cooking* 24147263 Chicken, drumstick, coated, baked or fried, prepared skinless, coating not eaten, made with oil* 24147265 Chicken, drumstick, coated, baked or fried, prepared skinless, coating not eaten, made without fat* 24157200 Chicken, thigh, coated, baked or fried, prepared with skin, NS as to skin/coating eaten, fat added in cooking* 24157210 Chicken, thigh, coated, baked or fried, prepared with skin, skin/coating eaten, NS as to type of fat added in cooking* 24157213 Chicken, thigh, coated, baked or fried, prepared with skin, skin/coating eaten, made with oil* 24157215 Chicken, thigh, coated, baked or fried, prepared with skin, skin/coating eaten, made without fat* 24157220 Chicken, thigh, coated, baked or fried, prepared with skin, skin/coating not eaten, NS as to type of fat added in cooking* 24157223 Chicken, thigh, coated, baked or fried, prepared with skin, skin/coating not eaten, made with oil* 24157240 Chicken, thigh, coated, baked or fried, prepared skinless, NS as to coating eaten, fat added in cooking* 24157250 Chicken, thigh, coated, baked or fried, prepared skinless, coating eaten, NS as to type of fat added in cooking* 24157253 Chicken, thigh, coated, baked or fried, prepared skinless, coating eaten, made with oil* 24157255 Chicken, thigh, coated, baked or fried, prepared skinless, coating eaten, made without fat* 24157260 Chicken, thigh, coated, baked or fried, prepared skinless, coating not eaten, NS as to type of fat added in cooking* 24157263 Chicken, thigh, coated, baked or fried, prepared skinless, coating not eaten, made with oil* 24167110 Chicken, wing, coated, baked or fried, prepared with skin, skin/coating eaten, NS as to type of fat added in cooking*

1708708.000 – 7281 40 Center for Chemical Regulation and Food Safety

Food Category Food code Food description 24167113 Chicken, wing, coated, baked or fried, prepared with skin, skin/coating eaten, made with oil* 24167115 Chicken, wing, coated, baked or fried, prepared with skin, skin/coating eaten, made without fat* 24167119 Chicken, wing, coated, baked or fried, prepared with skin, skin/coating not eaten, made without fat* 24167120 Chicken, wing, coated, baked or fried, prepared with skin, skin/coating not eaten, NS as to type of fat added in cooking* 24167123 Chicken, wing, coated, baked or fried, prepared with skin, skin/coating not eaten, made with oil* 24201050 Turkey, light meat, breaded, baked or fried, NS as to skin eaten* 24201060 Turkey, light meat, breaded, baked or fried, skin not eaten* 24201070 Turkey, light meat, breaded, baked or fried, skin eaten* 24208000 Turkey, nuggets* 26100130 Fish, NS as to type, coated, baked or broiled, made with oil* 26100133 Fish, NS as to type, coated, baked or broiled, made without fat* 26100140 Fish, NS as to type, coated, fried, made with oil* 26100143 Fish, NS as to type, coated, fried, made without fat* 26105140 Carp, coated, fried* 26107110 Catfish, cooked, NS as to cooking method* 26107130 Catfish, coated, baked or broiled, made with oil* 26107133 Catfish, coated, baked or broiled, made without fat* 26107140 Catfish, coated, fried, made with oil* 26107143 Catfish, coated, fried, made without fat* 26109130 Cod, coated, baked or broiled, made with oil* 26109133 Cod, coated, baked or broiled, made without fat* 26109140 Cod, coated, fried, made with oil* 26109143 Cod, coated, fried, made without fat* 26111140 Croaker, coated, fried* 26115110 Flounder, cooked, NS as to cooking method* 26115130 Flounder, coated, baked or broiled, made with oil* 26115132 Flounder, coated, baked or broiled, made with margarine* 26115133 Flounder, coated, baked or broiled, made without fat* 26115140 Flounder, coated, fried, made with oil* 26115141 Flounder, coated, fried, made with butter* 26117130 Haddock, coated, baked or broiled, fat added in cooking* 26117140 Haddock, coated, fried* 26119131 Herring, coated, baked or broiled, fat not added in cooking* 26121140 Mackerel, coated, fried* 26123140 Mullet, coated, fried* 26125130 Ocean perch, coated, baked or broiled, fat added in cooking* 26125140 Ocean perch, coated, fried* 26127133 Perch, coated, baked or broiled, made without fat* 26127140 Perch, coated, fried, made with oil* 26127141 Perch, coated, fried, made with butter* 26127143 Perch, coated, fried, made without fat*

1708708.000 – 7281 41 Center for Chemical Regulation and Food Safety

Food Category Food code Food description 26131140 Pompano, coated, fried* 26133130 Porgy, coated, baked or broiled, fat added in cooking* 26133140 Porgy, coated, fried* 26137130 Salmon, coated, baked or broiled, made with oil* 26137131 Salmon, coated, baked or broiled, made with butter* 26137133 Salmon, coated, baked or broiled, made without fat* 26137140 Salmon, coated, fried, made with oil* 26141140 Sea bass, coated, fried* 26149130 Swordfish, coated, baked or broiled, fat added in cooking* 26149140 Swordfish, coated, fried* 26151130 Trout, coated, baked or broiled, made with oil* 26151133 Trout, coated, baked or broiled, made without fat* 26151140 Trout, coated, fried, made with oil* 26151143 Trout, coated, fried, made without fat* 26153130 Tuna, fresh, coated, baked or broiled, fat added in cooking* 26153140 Tuna, fresh, coated, fried* 26157110 Whiting, cooked, NS as to cooking method* 26157130 Whiting, coated, baked or broiled, made with oil* 26157132 Whiting, coated, baked or broiled, made with margarine* 26157133 Whiting, coated, baked or broiled, made without fat* 26157140 Whiting, coated, fried, made with oil* 26158020 Tilapia, coated, baked or broiled, made with oil* 26158021 Tilapia, coated, baked or broiled, made with butter* 26158023 Tilapia, coated, baked or broiled, made without fat* 26158024 Tilapia, coated, baked or broiled, made with cooking spray* 26158030 Tilapia, coated, fried, made with oil* 26158033 Tilapia, coated, fried, made without fat* 26203110 Frog legs, NS as to cooking method* 26205110 Octopus, cooked, NS as to cooking method* 26213140 Squid, coated, fried* 26303140 Clams, coated, fried* 26305130 Crab, coated, baked or broiled, fat added in cooking* 26307140 Crab, soft shell, coated, fried* 26309140 Crayfish, coated, fried* 26311140 Lobster, coated, fried* 26315110 Oysters, cooked, NS as to cooking method* 26315140 Oysters, coated, fried* 26315160 Oysters, coated, baked or broiled, fat added in cooking* 26317140 Scallops, coated, fried* 26317160 Scallops, coated, baked or broiled, fat added in cooking* 26319110 Shrimp, cooked, NS as to cooking method* 26319140 Shrimp, coated, fried, made with oil* 26319141 Shrimp, coated, fried, made with butter* 26319142 Shrimp, coated, fried, made with margarine* 26319143 Shrimp, coated, fried, made without fat* 26319160 Shrimp, coated, baked or broiled, made with oil* 26319163 Shrimp, coated, baked or broiled, made without fat* 26319164 Shrimp, coated, baked or broiled, made with cooking spray*

1708708.000 – 7281 42 Center for Chemical Regulation and Food Safety

Food Category Food code Food description 27113300 Swedish meatballs with cream or white sauce (mixture)* 27116300 Beef with sweet and sour sauce (mixture)* 27120060 Sweet and sour pork* 27146250 Chicken or turkey cordon bleu* 27146300 Chicken or turkey parmigiana* 27146400 Chicken kiev* 27150170 Sweet and sour shrimp* 27220080 Ham croquette* 27246300 Chicken or turkey cake, patty, or croquette* 27250040 Crab cake* 27250070 Salmon cake or patty* 27250160 Tuna cake or patty* 27250220 Oyster fritter* 27250400 Shrimp cake or patty* 27250410 Shrimp with crab stuffing* 27250610 Tuna noodle casserole with cream or white sauce* 27250630 Tuna noodle casserole with (mushroom) soup* 27350080 Tuna noodle casserole with vegetables, cream or white sauce* 27350410 Tuna noodle casserole with vegetables and (mushroom) soup* 27450250 Oysters Rockefeller* 28110330 Salisbury steak with gravy, whipped potatoes, vegetable, dessert (frozen meal)* 28110350 Salisbury steak with gravy, potatoes, vegetable, dessert (frozen meal, large meat portion)* 28110380 Salisbury steak with gravy, macaroni and cheese (frozen meal)* 28110640 Meatballs, Swedish, in sauce, with noodles (frozen meal)* 28110660 Meatballs, Swedish, in gravy, with noodles (diet frozen meal)* 28140100 Chicken dinner, NFS (frozen meal)* 28140730 Chicken patty, breaded, with tomato sauce and cheese, fettuccine alfredo, vegetable (frozen meal)* 28143170 Chicken in cream sauce with noodles and vegetable (frozen meal)* 28145710 Turkey tetrazzini (frozen meal)* 28160300 Meat loaf dinner, NFS (frozen meal)* 28160310 Meat loaf with potatoes, vegetable (frozen meal)* 28160650 Stuffed green pepper (frozen meal)* 28315160 Italian Wedding Soup* 32105190 Egg casserole with bread, cheese, milk and meat* 32110150 Shrimp -egg patty (Torta de Cameron seco)* 41421020 Soybean curd, breaded, fried* 53440300 Strudel, berry* 53440500 Strudel, cherry* 53440600 Strudel, cheese* 58131100 Ravioli, NS as to filling, no sauce* 58131110 Ravioli, NS as to filling, with tomato sauce*

1708708.000 – 7281 43 Center for Chemical Regulation and Food Safety

Food Category Food code Food description 58131310 Ravioli, meat -filled, no sauce* 58131320 Ravioli, meat -filled, with tomato sauce or meat sauce* 58131330 Ravioli, meat -filled, with cream sauce* 58145110 Macaroni or noodles with cheese* 58162090 Stuffed pepper, with meat* 58162120 Stuffed pepper, with rice, meatless* 58163510 Rice dressing* 72125260 Spinach and cheese casserole* 72202010 Broccoli casserole (broccoli, noodles, and cream sauce)* 72202020 Broccoli casserole (broccoli, rice, cheese, and mushroom sauce)* 73305010 Squash, winter, baked with cheese* 74203010 Tomatoes, NS as to form, scalloped* 74204011 Tomatoes, from fresh, stewed* 75410550 Jalapeno pepper, stuffed with cheese, breaded or battered, fried* 75414020 Mushrooms, stuffed* 75418020 Squash, summer, casserole with tomato and cheese* 75418040 Squash, summer, casserole, with cheese sauce* 15 Ice cream inclusions (wafers, 11461250 Yogurt, frozen, cone, chocolate* cones, broken cookie pieces or crumbs) 11461260 Yogurt, frozen, cone, flavors other than chocolate* 11461270 Yogurt, frozen, cone, flavors other than chocolate, lowfat milk* 13120700 Ice cream cone with nuts, flavors other than chocolate* 13120710 Ice cream cone, chocolate covered, with nuts, flavors other than chocolate* 13120720 Ice cream cone, chocolate covered or dipped, flavors other than chocolate* 13120730 Ice cream cone, no topping, flavors other than chocolate* 13120750 Ice cream cone with nuts, chocolate ice cream* 13120760 Ice cream cone, chocolate covered or dipped, chocolate ice cream* 13120770 Ice cream cone, no topping, chocolate ice cream* 13120780 Ice cream cone, chocolate covered, with nuts, chocolate ice cream* 13120790 Ice cream sundae cone* 13130620 Light ice cream, soft serve cone, flavors other than chocolate (formerly ice milk)* 13130630 Light ice cream, soft serve cone, chocolate (formerly ice milk)* 13140500 Light ice cream, cone, flavors other than chocolate (formerly ice milk)* 13140575 Light ice cream, no sugar added, cone, flavors other than chocolate* 13140580 Light ice cream, no sugar added, cone, chocolate* 53222020 Cookie, cone shell, ice cream type, wafer or cake 53236000 Cookie, pizzelle (Italian style wafer) 16 Baby f ood: teething 53803050 Cookie, fruit, baby food

1708708.000 – 7281 44 Center for Chemical Regulation and Food Safety

Food Category Food code Food description crackers/biscuits 53803100 Cookie, baby food 53803250 Cookie, teething, baby 53803300 Cookie, rice, baby 54350000 Crackers, baby food *Only the target ingredient corresponding to the food category was included in the analysis.

1708708.000 – 7281 45 Food Safety & Nutrition

Proposition 65: Science & Data for Effective Advocacy

Barbara Petersen, Ph.D. Carolyn Scrafford, Ph.D.

November 2, 2017 Food Safety & Nutrition Key Questions for Today

• What are the scientific data needs to effectively advocate for and determine compliance with Prop 65?

• What steps can be taken by:

• Individual companies?

• Industry-wide? Food Safety & Nutrition Defense’s data burden

3 • What is the true level of the compound in your product? • What is the average rate of intake of the compound from product by the average consumer of your product? • How does that average rate of intake compare to the established or developed “safe harbor”? Food Safety & Nutrition Defense’s data burden

4

Average level of Average daily Average compound in X rate of intake = daily exposure to product of product compound

Average < Don’t warn daily exposure to Safe Harbor Level compound > Warn Food Safety & Nutrition Defense’s data burden

5 Data needs Average level of Statistically valid Validated Factors affecting compound in sampling program analytical methods levels in product product

Average daily Consumption Consumption What is “average” rate of intake amounts frequency of product

Safe Harbor Level Develop NSRL Rationale for an (where applicable) ASRL

Products data

Mitigation efforts

Health benefits Food Safety & Nutrition What is the true level of the compound in your product? 6 • Statistically valid sampling program • Samples collected represent: • The product as consumed by Californians • All potential sources of ingredients/suppliers • All potential manufacturing locations/processes Sample size sufficient to estimate the mean level of the compound in the product Food Safety & Nutrition What is the true level of the compound in your product? 7 • “Validated” analytical method in a certified laboratory • 27CCR§25900 • “The method of detection and analysis was conducted by a laboratory certified by the State of California or accredited by the Sate of California, a federal agency, the NELAP or similar nationally recognized accrediting organization to perform the particular method of detection and analysis in questions;…” • “The methods of detection and analysis that may be relied on for purposes of subsection (a) are those that are required or sanction by FDA, U.S.EPA, OSHA, NIOSH, CPSC, CDHS, CalEPA, …” • “must use the most sensitive method of detection and analysis…” Food Safety & Nutrition

What is the average rate of intake? 8 • How much do people consume? • Labelled serving size • NHANES consumption data (2-day survey and FFQ) • Other data: • California sales data • Nielsen/IRI • NPD/NET • Published literature • REMEMBER - Need to estimate: “average rate of intake for average users” Food Safety & Nutrition

What is the average rate of intake? 9 • What is “average”? • Arithmetic mean • Geometric mean • Median • Mode • Should be data-driven Food Safety & Nutrition How does that average rate of intake compare to the established or developed “safe harbor”? 10 • Derivation of “safe harbor” • Risk of cancer: 1 in 100,000 over 70 year lifetime • Acrylamide: 0.2 ug/day • Glyphosate: 1,100 ug/day • Furfuryl alcohol: ?? • Comparison between acrylamide and furfuryl alcohol and the underlying data Food Safety & Nutrition How does that average rate of intake compare to the established or developed “safe harbor”? 11 • Argument for ASRL • Risk of cancer: 1 in 10,000 over 70 year lifetime • 27CCR§25703: “sound considerations of public health support an alternative level” • “Cooking exemption” • Mitigation efforts have resulted in lowest achievable levels • Compound is formed through natural cooking/heating processes • “Good for you” Food Safety & Nutrition Individual companies

12 • Document exposure for your product portfolio • Consumption (for unique products) • Analytical levels • Document source/formation of compounds throughout manufacturing process • Raw materials • Processing aids • Finished products Food Safety & Nutrition Coordinated efforts

13 • Consumption • Can not be brand specific so could be advantageous for industry-wide coordination • E.g., sliced white bread, hot dog buns, wheat crackers, chocolate chip cookies • Can be used for more than one compound • Analytical methodology • Validation of analytical method • Furfuryl alcohol • Glyphosate • Research on factors affecting levels in products • Development of NSRL • Furfuryl alcohol • Argument for ASRL (acrylamide, furfuryl alcohol) • Food science/formation data • Health benefits • Mitigation efforts/research Food Safety & Nutrition Contact information

• Barbara Petersen [email protected] • Carolyn Scrafford [email protected]

August 28, 2018

Memorandum

To: American Bakers Association

From: MaryJoy Ballantyne, Covington & Burling LLP

Re: Recent State, Judicial, and Federal Activities on Proposition 65 and Their Implications for Food Products

This memorandum provides a high-level overview of recent activities taken by California’s Office of Environmental Health Hazard Assessment (OEHHA), the courts, and Congress related to Proposition 65 and food products. The recent activities summarized below identify a few vulnerabilities for food products but some represent different approaches the food industry or sectors of the food industry could leverage to reign in the Prop 65 litigation against food products.

I. OEHHA Establishes Regulation for Background Levels of “Naturally Occurring” Substances (August 9, 2018)

Since at least 2015, OEHHA has been considering how and whether to adopt regulations for naturally-occurring background levels of certain Prop 65 listed chemicals, such as lead and arsenic, in un-processed foods. Under Prop 65, substances that are “naturally occurring” (as defined by the statute) are excluded from the amount of a listed chemical when calculating whether exposure to the listed chemicals is in an amount that triggers a Prop 65 warning.

Unfortunately, the Prop 65 statutory definition of “naturally occurring” is very narrow (see 22 Cal. Code Regs. § 25501) and courts have interpreted the definition in various ways, leaving the application of “naturally occurring” with little practical utility.

On August 9, 2018, OEHHA finalized its first of this type of regulation by establishing default natural background levels for inorganic arsenic in white and brown rice (80 ppb for white rice, 170 ppb for brown rice) (see 27 Cal. Code. Regs. 25501.1). Currently, arsenic is listed under Prop 65 as a carcinogen, and has a published safe harbor level (no significant risk level (NSRL)) of 10 µg/day (except via inhalation) by ingestion and 0.06 µg/day by inhalation. Thus, there is debate as to whether the new naturally occurring background levels finalized by OEHHA provide any meaningful relief to companies who manufacture rice products.

Even so, the fact that OEHHA has established a regulation to carve-out naturally occurring background levels of a Prop 65 listed chemical may be potentially helpful as precedent for other Prop 65 listed chemicals that may also be attributed in part or whole as naturally occurring.

August 28, 2018 Page 2

II. Appellate Decision Concludes that Prop 65 Acrylamide Warning on Grain Cereals is Preempted by Federal Nutrition Policies (July 16, 2018)

On July 16, 2018, a California appellate court reversed the trial court and ruled (in a unanimous 3-justice panel) that a Prop 65 acrylamide warning on 59 breakfast cereals (manufactured by Post, General Mills, and Kellogg) was preempted by federal nutrition policies. See Post Foods LLC et al. v. The Superior Court of Los Angeles County et al., case number B284057, in the Court of Appeal of the State of California. The federal nutrition policies upon which the court relied to find preemption were directed at encouraging Americans to consume more whole grains and were supported by FDA in two letters it sent to OEHHA in 2003 and 2006.

In finding that the Prop 65 warning was an obstacle to achieving the federal policies of increased grain consumption, the appellate court was compelled by concerns expressed by FDA that “premature labeling of many foods with warnings about dangerous levels of acrylamide would confuse and could potentially mislead consumers, both because the labeling would be so broad as to be meaningless and because the risk of consumption of acrylamide in food is not yet clear.”

The appellate court’s decision illustrates the on-going tension between food nutrition policies and the seemingly unsubstantiated Prop 65 warnings on food products, where the warnings are based on non-specific scientific observations assessing disease risk in isolation without considering the potential protective or preventive effect of nutrients found in foods.

Subsequent to the appellate court decision, the plaintiff filed for a rehearing, which the court denied on August 15, 2018 and then filed for appeal on August 24, 2018 to the California Supreme Court. It could be several months or years before the California Supreme Court reaches a final decision.

III. OEHHA Proposes a Regulation to Exclude Coffee from Prop 65 Warnings (June 15, 2018)

After years of tumultuous Prop 65 litigation against coffee--most notably against Starbucks--and only months after a California judge concluded that Starbucks and dozens of other co-defendants had failed to prove that the level of acrylamide in coffee poses no significant health risk, OEHHA announced on June 15, 2018 its intent to exclude coffee from Prop 65 warnings based on findings made by the International Agency for Research on Cancer (IARC). IARC is an agency of the World Health Organization (WHO).

The IARC’s conclusions, in turn, were based on a review of “more than 1,000 studies,” according to OEHHA’s website. As stated on OEHHA’s website, IARC concludes that: (1) there is “inadequate evidence” that drinking coffee causes cancer, (2) coffee is associated with protective effects such as reduced risk for cancers of the liver and uterus along with strong antioxidant effects related to reduced cancer risk, and (3) coffee does not cause cancers of the breast, pancreas, or prostate.

Based on the IARC study, OEHHA has proposed the following (very broad) regulation that appears to exclude coffee from Prop 65 warning requirements for any listed chemicals that may be inherent in coffee or standard coffee processing: “Exposures to listed chemicals in coffee

August 28, 2018 Page 3 created by and inherent in the processes of roasting coffee beans or brewing coffee do not pose a significant risk of cancer.”

OEHHA held a public hearing August 16, 2018 and will close the comment period on its proposed regulation on August 30, 2018.

As with the other recent Prop 65 activities summarized herein, OEHHA’s regulation to exclude coffee from Prop 65 warnings by finding that the benefits of consuming coffee outweigh the potential risks could be helpful precedent if the weight of the credible scientific evidence demonstrates that, for example, the benefits of consuming grains or other foods outweighs the potential risks from exposures to certain listed chemicals.

IV. Glyphosate is Targeted in Numerous Lawsuits

Glyphosate (aka Round Up) has received a significant amount of attention this year in a host of judicial decisions and other activities.

Earlier this year, on February 26, 2018, a federal trial court in California granted, in part, a preliminary injunction enjoining OEHHA and others from enforcing the Prop 65 warning requirement for glyphosate. The case was filed by the National Association of Wheat Growers (NAWG) in November 2017, four months after California added glyphosate to its Prop 65 list of chemicals. Under the first amendment, the court concluded that the Prop 65 warning on glyphosate--e.g., that glyphosate was “known to . . . cause cancer”--would be “inherently misleading” because it was based on an IARC conclusion that glyphosate was only “possibly carcinogenic.” The court, however, upheld the glyphosate warning, for which OEHHA finalized a NSRL of 1100 µg/day, effective July 1, 2018. Technically, glyphosate remains a listed chemical and the injunction only applies to parties that were subject to the litigation. Even so, the injunction, along with statements from the court’s decision (which it upheld upon a rehearing) may act as a disincentive to other plaintiffs. OEHHA has appealed the trial court’s decision, so only time will tell whether and how long the injunction will remain in force.

Several consumer deception lawsuits have been filed in recent years alleging that “natural” claims on products containing residues of glyphosate are deceptive. Many of these lawsuits, particularly one involving Quaker Oats (see Gibson v. Quaker Oats, 1:16--cv-04853), have been dismissed in favor of the defendants (but the plaintiff has since appealed).

In contrast, a jury recently (August 10, 2018) awarded $289 million in damages in a personal injury case to a grounds worker who used Round Up for years as part of his employment and who alleged that exposure to glyphosate caused his cancer (see Johnson v. Monsanto, 3:17-cv-05160). Monsanto/Bayer, the manufacturer of Round Up, has appealed the decision.

On August 15, 2018, the Environmental Working Group (EWG) released a study reviewing glyphosate levels in oat-based products, comparing glyphosate levels in ppb in organic and conventional oat-based products. Although EWG’s study focuses on oats, it mentions glyphosate use on wheat: “glyphosate is also sprayed just before harvest on wheat, barley, oats and beans that are not genetically engineered. Glyphosate kills the crop, drying it out so that it can be harvested sooner than if the plant were allowed to die naturally.”

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The day after EWG released its report, a consumer filed a class action law suit against General Mills under Florida state consumer protection statutes, alleging that General Mills had a duty to disclose the presence of glyphosate in Cheerios, but failed to do so (see Doss v. General Mills Inc., 0:18-cv-61924). To support that glyphosate is harmful to human health, the complaint references, among other things, the fact that glyphosate is listed under Prop 65 as a carcinogen.

On the heels of all these activities on August 20, 2018, NY Senator Chuck Schumer demanded that FDA make public the information it has gathered on glyphosate, including glyphosate levels in foods.

V. Congress Proposes Bipartisan Federal Legislation, “Accurate Labels Act” in part to Mitigate Prop 65 Lawsuits (June 6, 2018)

Both the House and Senate introduced bipartisan legislation on June 6, 2018 (H.R. 6022 and S. 3019) entitled the “Accurate Labels Act” (through Sen. Moran (R-Kan) and Reps. Kinzinger (R-Ill) and Schrader (D-Ore).

The companion bills seek to amend the federal Fair Packaging and Labeling Act (FPLA) to facilitate uniform labeling standards across consumer goods and commodities. According to Senator Moran’s statement, the main purpose of the Accurate Labels Act is to provide consumers access to accurate and easy-to-understand product information by:

• Establishing science-based criteria for all state and local labeling requirements that exceed current federal standards.

• Allowing state-mandated product information to be provided through smartphone- enabled “smart labels” and on websites.

• Ensuring that covered product information is risk-based.

The proposed legislation would otherwise leave unchanged the current federal laws related to labeling.

A few key provisions, including the following, would provide food companies (and other industries) additional leverage in Proposition 65 litigation and potentially create a higher burden of proof that plaintiff lawyers must meet prior to filing a Prop 65 60-day notice:

• “Best Available Science”: The bills propose to define this term to mean

“science--

‘‘(A) that is conducted in accordance with sound and objective scientific practices;

‘‘(B) the findings and underlying data of which are—

‘‘(i) reliable; and

‘‘(ii) if available, peer-reviewed; and

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‘‘(C) that uses data that is collected by—

‘‘(i) an accepted method; or

‘‘(ii) the best available method if the reliability of the method and the nature of the decision to which the method applies justifies the use of the data.”

This definition is aimed, in part, at responding to California’s seemingly less-than-robust scientific evidence for listing chemicals as carcinogens and reproductive toxicants under Prop 65.

• “Naturally Occurring”: The bills propose to define this term to mean,

“with respect to a constituent . . . that the constituent occurs in--

‘‘(A) any plant, animal, or microorganism, or any raw material or a constituent derived from a plant, animal, or microorganism, that composes or is a part of the covered product; and

‘‘(B) the covered product because of—

‘‘(i)(I) activity that is authorized pursuant to regulation or permitting; or

‘‘(II) human activity; and

‘‘(ii) any physical processing, preparation, or packaging of—

‘‘(I) a plant, animal, or microorganism; or

‘‘(II) any raw material or constituent derived from an entity described in subclause (I).”

Under Prop 65, there is a provision that excludes “naturally occurring” substances from the warning requirement. Unfortunately, the Prop 65 definition is unclear and judicial interpretations have further muddied the clarity and utility of this exemption. In the federal bills, the definition of “naturally occurring” is intended to provide a broader, clearer, and more readily accessible standard for assessing substances that are “naturally occurring” and therefore not subject to a Prop 65 warning. For example, under this definition, levels of acrylamide due to processing activities (e.g., heating) or due to consumer activities would be included in the federal definition of “naturally occurring” and therefore preempted from the Prop 65 warning.

The bills also propose numerous other definitions such as “De Minimis Risk Level” and “Risk-Based” that would alter how to assess risk of harm, which would likely make it more difficult for a plaintiff to demonstrate harm and therefore the need for a warning under Prop 65.

Further, the bills appear to preempt warnings on products if the problematic constituent that would trigger the warning is “below 0.1 percent” in the product.

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Another provision that could greatly mitigate potential Prop 65 litigation is the bill’s burden of proof requirement that a plaintiff must demonstrate in order to bring a complaint for a product covered by the bills. Currently, under Prop 65, a plaintiff has almost no burden of proof other than to allege (and demonstrate with hardly any proof) that a product does not carry a clear and reasonable warning and exposes a consumer to a Prop 65 listed chemical at a level that is outside the safe harbor level. In contrast, the proposed federal burden of proof would require a plaintiff to establish by a preponderance of the evidence that a product does not meet the federal standards. If the plaintiff does not meet this burden of proof the claim is presumed to be federally preempted and would not be required to bear, for example, a Prop 65 warning.

VI. Conclusion

ABA and Covington continue to monitor and will keep members abreast of relevant Prop 65 activities. In addition, ABA and Covington will continue to look for and pursue opportunities to engage lawmakers and others on actions that will mitigate the burdens of Prop 65 on bakers.