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TRANSCRIPT
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.
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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/ChemicalContaminantsMetalsNaturalToxinsPesticides/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
High Cocoa (excluding 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/GuidanceDocumentsRegulatoryInformation/ChemicalContaminantsMetalsNaturalToxinsPesticides/UCM374534.pdf FoodDrinkEurope Acrylamide Toolbox; http://www.fooddrinkeurope.eu/uploads/publications_documents/AcrylamideToolbox_2013.pdf A “Toolbox” for the Reduction of Acrylamide in Bread Products; http://www.fooddrinkeurope.eu/uploads/publications_documents/Toolboxfinal260911.pdf A “Toolbox” for the Reduction of Acrylamide in Fine bakery wares; https://ec.europa.eu/food/sites/food/files/safety/docs/cs_contaminants_catalogue_acrylamide_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_acrylamide_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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18
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
DC: 6553488-3
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…)
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:
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).
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.
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
µg/day)
NA
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:
DRAFT October 27, 2017 Page 11
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
1708708.000 – 7281
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.
Center for Chemical Regulation and Food Safety
1708708.000 – 7281 3
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
Center for Chemical Regulation and Food Safety
1708708.000 – 7281 4
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
Center for Chemical Regulation and Food Safety
1708708.000 – 7281 5
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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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 toxicity1. 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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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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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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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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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, and buns (21 CFR § 136.115)
White breads, rolls, and buns; Cuban, French or Vienna, Italian, and flatbread; breads not specific as to major flour; and includes the component in sandwiches, burgers, and mixtures such as meat loaf,
Breads/rolls, white
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Food Category NHANES Food Selection Summary FFQ Food
bread pudding, etc.
2 Milk bread, rolls, and buns (21 CFR § 136.130)
Milk breads not reported consumed. Breads not specific as to major flour selected as surrogate.
Breads/rolls, not white
3 Raisin bread, rolls, and buns (21 CFR § 136.160)
Raisin bread (includes raisin pita bread); breads not specific as to major flour.
Breads/rolls, white
4 Whole wheat bread, rolls, and buns (21 CFR § 136.180)
Whole wheat bread (including French or Vienna, pita), rolls, buns; breads not specific as to major flour; and includes the component in sandwiches.
Breads/rolls, not white
5 Potato bread, rolls and buns
Potato bread and breads not specific as to major flour.
Breads/rolls, not white
6 Variety breads (rye; pumpernickel; whole grain; 7-12 grain breads/rolls; pulse and vegetable)
Breads, rolls, and buns including bran, white with whole wheat swirl, garlic, onion, high protein, sweet potato, vegetable, sprouted wheat, whole grain 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.
Breads/rolls, not white
7 Biscuits Biscuit and the component in breakfast sandwiches.
Biscuits
8 Donuts Donuts, all types Doughnuts/Sweet Rolls/Danish/Pop Tarts
9 Cookies All types such as almond, biscotti, cookie bars, cookie sandwiches, cookie wafer, fruit filled, oatmeal, peanut butter, marshmallow cookie, shortbread, animal cookie, etc.1
Brownies/Cookies
10 Crackers, crisp (enriched; whole grain; rye)
Crackers not specific as to type, melba toast, zwieback toast, toast thins, high 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).
Crackers
11 Croutons and stuffing Croutons and dry stuffing and its component in mixtures such as ham stuffing, dressing with oysters, and salads.
Stuffing/dumplings; lettuce 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 its component in sandwiches. Includes regular, wheat, whole wheat types.
not white2
13 Tortillas (flour and corn) Tortilla (corn, flour, whole wheat), taco shell (corn, flour), and gordita/sope shell and its component in wrap sandwiches, burritos and tacos, other Mexican dishes, and soups.
Tortillas/Tacos
14 Breading (Panko type used in further processing)
Breading/bread crumb component in breaded or coated meats and seafood, casseroles, meat cake or patty, meat loaf, and pasta dishes.
Tuna; Ground Beef in Mixtures; Chicken salads/mixtures; Chicken (not in a salad/mixtures); Fried Fish/Fish sticks
15 Ice cream inclusions (wafers, cones, broken cookie pieces or crumbs)
Ice cream cones (i.e., cake or wafer-type, sugar rolled-type) and its component ice cream desserts3.
Ice Cream/Ice Cream Bars/Sherbet
16 Baby food: teething crackers/biscuits
Baby cookies (i.e., fruit, teething, rice) and crackers
Not available
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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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:
Usual daily intake of food � g
day� = �mean intake amount � g
EO�� × �mean frequency of consumption �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
Food Categories N* % User
Per User
two-day average intake (g/day)
Arithmetic Mean
Geometric Mean
1 Enriched bread, rolls, and buns (21 CFR § 136.115)
8,353 59 47.7 36.0
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 § 136.180)
1,906 14 39.9 33.3
5 Potato bread, rolls and buns 140 1 32.2 26.6
6 Variety breads (rye; pumpernickel; whole grain; 7-12 grain breads/rolls; pulse and vegetable)
4,129 28 39.5 32.8
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 cookie pieces or crumbs)b
512 3 3.5 3.0
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
Food Categories
Amount Consumed per Eating Occasiona Frequency of Consumptionb Usual Intakec
N* %
User
Arithmetic Mean
Geometric Mean
FFQ Food
Arithmetic Mean
Geometric Mean
Arithmetic Mean
Geometric Mean
- - - g/EO - - - - - - EO/day - - - - - - g/day - - -
1 Enriched bread, rolls, and buns (21 CFR § 136.115)
8,353 59 56.9 46.9 Breads/rolls, white 0.43 0.22 24.5 10.3
2 Milk bread, rolls, and buns (21 CFR § 136.130)d
91 0.4 50.5 42.0 Breads/rolls, not white
0.37 0.19 18.7 8.0
3 Raisin bread, rolls, and buns (21 CFR § 136.160)
192 1 42.0 36.8 Breads/rolls, white 0.43 0.22 18.1 8.1
4 Whole wheat bread, rolls, and buns (21 CFR § 136.180)
1,906 14 57.3 51.7 Breads/rolls, not white
0.37 0.19 21.2 9.8
5 Potato bread, rolls and buns 140 1 56.7 48.2 Breads/rolls, not white
0.37 0.19 21.0 9.2
6 Variety breads (rye; pumpernickel; whole grain; 7-12 grain breads/rolls; pulse and vegetable)
4,129 28 55.5 48.8 Breads/rolls, not white
0.37 0.19 20.5 9.3
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 Rolls/Danish/Pop Tarts
0.11 0.05 7.2 2.8
9 Cookies 4,899 32 44.5 35.0 Brownies/Cookies 0.20 0.09 8.9 3.2
10 Crackers, crisp (enriched; whole grain; rye)
507 5 27.1 21.1 Crackers 0.18 0.07 4.9 1.5
11 Croutons and stuffing 518 5 14.8 7.3 Stuffing/dumplings; lettuce salads
0.31 0.16 4.6 1.2
12 Flat breads (naan/focaccia) 498 3 71.7 58.9 Breads/rolls, white and not whitee
0.63 0.38 45.2 22.4
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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Food Categories
Amount Consumed per Eating Occasiona Frequency of Consumptionb Usual Intakec
N* %
User
Arithmetic Mean
Geometric Mean
FFQ Food
Arithmetic Mean
Geometric Mean
Arithmetic Mean
Geometric Mean
- - - g/EO - - - - - - 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, cones, broken cookie pieces or crumbs)f
512 3 6.6 5.8 Ice Cream/Ice Cream Bars/Sherbet
0.17 0.08 1.1 0.5
16 Baby food: teething crackers/biscuits
75 0.2 14.3 8.3 NA NA NA NA NA
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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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 buns (21 CFR § 136.115)
13210110 Pudding, bread*
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
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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
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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 (21 CFR § 136.130)
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
3 Raisin bread, rolls, and buns (21 CFR § 136.160)
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
51129010 Bread, raisin
51129020 Bread, raisin, toasted
4 Whole wheat bread, rolls, and buns (21 CFR § 136.180)
27540230 Chicken patty sandwich with cheese, on wheat bun, with 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,
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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; pumpernickel; whole grain; 7-12 grain breads/rolls; pulse and vegetable)
27510480 Cheeseburger (hamburger with cheese sauce), 1/4 lb meat, with grilled onions, on rye bun*
27510950 Reuben sandwich (corned beef sandwich with sauerkraut and
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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
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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
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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
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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
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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; whole grain; rye)
51187000 Melba toast
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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,
Center for Chemical Regulation and Food Safety
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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*
Center for Chemical Regulation and Food Safety
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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*
Center for Chemical Regulation and Food Safety
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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 further processing)
21103110 Beef steak, breaded or floured, baked or fried, NS as to fat eaten*
Center for Chemical Regulation and Food Safety
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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*
Center for Chemical Regulation and Food Safety
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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 (drumstick 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, baked or fried, prepared with skin,
Center for Chemical Regulation and Food Safety
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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*
Center for Chemical Regulation and Food Safety
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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*
Center for Chemical Regulation and Food Safety
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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*
Center for Chemical Regulation and Food Safety
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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*
Center for Chemical Regulation and Food Safety
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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, cones, broken cookie pieces or crumbs)
11461250 Yogurt, frozen, cone, chocolate*
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 food: teething 53803050 Cookie, fruit, baby food
Center for Chemical Regulation and Food Safety
1708708.000 – 7281 45
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.
Food Safety & Nutrition
November 2, 2017
Barbara Petersen, Ph.D.Carolyn Scrafford, Ph.D.
Proposition 65: Science & Data for Effective Advocacy
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
• 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”?
3
Food Safety & Nutrition
4
Defense’s data burden
X
Average daily rate of intake
of product=
Average daily exposure to
compound
Average daily exposure to
compound
<
>
Safe Harbor LevelDon’t warn
Warn
Average level of compound in
productX =
Food Safety & Nutrition
Defense’s data burden5
Average level of compound in
product
Average daily rate of intake
of product
Safe Harbor Level
Statistically valid sampling program
Validated analytical methods
Factors affecting levels in product
Consumption amounts
Consumption frequency
What is “average”
Develop NSRL (where applicable)
Rationale for an ASRL
Products data
Mitigation efforts
Health benefits
Data needs
Food Safety & Nutrition
What is the true level of the compound in your product?
• Statistically valid sampling program• Samples collected represent:
• The product as consumed by Californians• All potential sources of ingredients/suppliers• All potential manufacturing locations/processesSample size sufficient to estimate the mean level of the compound in the product
6
Food Safety & Nutrition
What is the true level of the compound in your product?
• “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…”
7
Food Safety & Nutrition
What is the average rate of intake?
• 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”
8
Food Safety & Nutrition
What is the average rate of intake?
• What is “average”?• Arithmetic mean• Geometric mean• Median• Mode
• Should be data-driven
9
Food Safety & Nutrition
How does that average rate of intake compare to the established or developed “safe harbor”?
• 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
10
Food Safety & Nutrition
How does that average rate of intake compare to the established or developed “safe harbor”?
• 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”
11
Food Safety & Nutrition
Individual companies
• 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
12
Food Safety & Nutrition
Coordinated efforts
• 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
13
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.”
August 28, 2018 Page 4
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
August 28, 2018 Page 5
‘‘(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.
August 28, 2018 Page 6
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.