Existing law, the Sherman Food, Drug, and Cosmetic Law, provides for the regulation of various subjects relating to the manufacturing, processing, labeling, advertising, and sale of food, drugs, and cosmetics, under the administration and enforcement of the State Department of Public Health. A violation of these provisions is punishable as a misdemeanor.

This bill would require a manufacturer of baby food for sale or distribution in this state, beginning on January 1, 2024, to test a representative sample of each production aggregate of the manufacturers final baby food product, at a proficient laboratory meeting certain criteria, for toxic elements, as defined, at least once per month. The bill would require a manufacturer to provide test results to any authorized agent of the department upon their request, as specified. The bill would require a manufacturer of a final baby food product sold, manufactured, delivered, held, or offered for sale in the state on and after January 1, 2025, to provide specified information disclosures to consumers, including making publicly available on its internet website the name and level of each toxic element present in each production aggregate of the final baby food product.

If a product is tested for a certain toxic element subject to an action level, regulatory limit, or tolerance established by the United States Food and Drug Administration, the bill would require manufacturers to include on the product label a quick response (QR) code that links to a page on the manufacturers internet website containing, among other information, test results for the toxic element and a link to related FDA guidance, as specified.

The bill would prohibit a person or entity from selling in the state or manufacturing, delivering, holding, or offering for sale in the state any baby food that does not comply with these provisions. By creating a new crime, the bill would impose a state-mandated local program.

The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.

This bill would provide that no reimbursement is required by this act for a specified reason.

Existing law, the Sherman Food, Drug, and Cosmetic Law, provides for the regulation of various subjects relating to the manufacturing, processing, labeling, advertising, and sale of food, drugs, and cosmetics, under the administration and enforcement of the State Department of Public Health. A violation of these provisions is punishable as a misdemeanor.

This bill would require a manufacturer of baby food for sale or distribution in this state, beginning on January 1, 2024, to test a representative sample of each production aggregate of the manufacturers final baby food product, at a proficient laboratory meeting certain criteria, for toxic elements, as defined, at least once per month. The bill would require a manufacturer to provide test results to any authorized agent of the department upon their request, as specified. The bill would require a manufacturer of a final baby food product sold, manufactured, delivered, held, or offered for sale in the state on and after January 1, 2025, to provide specified information disclosures to consumers, including making publicly available on its internet website the name and level of each toxic element present in each production aggregate of the final baby food product.

If a product is tested for a certain toxic element subject to an action level, regulatory limit, or tolerance established by the United States Food and Drug Administration, the bill would require manufacturers to include on the product label a quick response (QR) code that links to a page on the manufacturers internet website containing, among other information, test results for the toxic element and a link to related FDA guidance, as specified.

The bill would prohibit a person or entity from selling in the state or manufacturing, delivering, holding, or offering for sale in the state any baby food that does not comply with these provisions. By creating a new crime, the bill would impose a state-mandated local program.

The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.

This bill would provide that no reimbursement is required by this act for a specified reason.

Existing law, the Sherman Food, Drug, and Cosmetic Law, provides for the regulation of various subjects relating to the manufacturing, processing, labeling, advertising, and sale of food, drugs, and cosmetics, under the administration and enforcement of the State Department of Public Health. A violation of these provisions is punishable as a misdemeanor.

This bill would require an in-state or out-of-state a manufacturer of baby food for sale or distribution in this state, beginning on January 1, 2024, to test a representative sample of each production aggregate of the manufacturers final baby food product, as defined, for toxic heavy metals, including levels of lead, mercury, cadmium, and arsenic. product, at a proficient laboratory meeting certain criteria, for toxic elements, as defined, at least once per month. The bill would require a manufacturer to provide test results to any authorized agent of the department upon their request, as specified. The bill would require a manufacturer of a final baby food product sold, manufactured, delivered, held, or offered for sale in the state, state on and after January 1, 2025, to provide specified information disclosures to consumers, including making publicly available on its internet website the name and level of each toxic heavy metal element present in each product aggregate of the final baby food product. For baby food products for which the federal Food and Drug Administration (FDA) has established an action level, regulatory limit, or tolerance for a certain toxic heavy metal, the

If a product is tested for a certain toxic element subject to an action level, regulatory limit, or tolerance established by the United States Food and Drug Administration, the bill would require manufacturers to include on the product label a quick response (QR) code that links to a page on the manufacturers internet website containing, among other information, test results for the toxic heavy metal. The element and a link to related FDA guidance, as specified.

The bill would prohibit a person or entity from selling in the state or manufacturing, delivering, holding, or offering for sale in the state any baby food that does not comply with these provisions. By creating a new crime, the bill would impose a state-mandated local program.

The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.

This bill would provide that no reimbursement is required by this act for a specified reason.

Existing law, the Sherman Food, Drug, and Cosmetic Law, provides for the regulation of various subjects relating to the manufacturing, processing, labeling, advertising, and sale of food, drugs, and cosmetics, under the administration and enforcement of the State Department of Public Health. A violation of these provisions is punishable as a misdemeanor.

This bill would require an in-state or out-of-state manufacturer of baby food for sale or distribution in this state, beginning on January 1, 2024, to test a representative sample of each production aggregate of the manufacturers final baby food product, as defined, for toxic heavy metals, including levels of lead, mercury, cadmium, and arsenic. The bill would require a manufacturer of baby food sold, manufactured, delivered, held, or offered for sale in the state, on and after January 1, 2025, to provide specified information disclosures to consumers, including making publicly available on its internet website the name and level of each toxic heavy metals metal present in each product aggregate of the final baby food product. For baby food products for which the federal Food and Drug Administration (FDA) has established an action level, regulatory limit, or tolerance for a certain toxic heavy metal, the bill would require manufacturers to disclose include on the product label that the product, as part of a production aggregate, has been tested for that toxic heavy metal. For baby food products that, as part of a production aggregate, do not exceed an action level, regulatory limit, or tolerance established by the FDA for a toxic heavy metal, the bill would require manufacturers to include on the label that the product meets FDA guidance. a quick response (QR) code that links to a page on the manufacturers internet website containing, among other information, test results for the toxic heavy metal. The bill would prohibit a person or entity from selling in the state or manufacturing, delivering, holding, or offering for sale in the state any baby food that does not comply with these provisions. By creating a new crime, the bill would impose a state-mandated local program.

The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.

This bill would provide that no reimbursement is required by this act for a specified reason.

Existing law, the Sherman Food, Drug, and Cosmetic Law, provides for the regulation of various subjects relating to the manufacturing, processing, labeling, advertising, and sale of food, drugs, and cosmetics, under the administration and enforcement of the State Department of Public Health. A violation of these provisions is punishable as a misdemeanor.

This bill would require an in-state or out-of-state manufacturer of infant formula or baby food for sale or distribution in this state, beginning on January 1, 2024, to test a representative sample of their each production aggregate of the manufacturers final infant formula or baby food product, as defined, for toxic heavy metals, including levels of lead, mercury, cadmium, and arsenic. The bill would require a manufacturer, for infant formula or manufacturer of baby food sold, manufactured, delivered, held, or offered for sale in the state, on and after January 1, 2025, to provide specified information disclosures to consumers, including making publicly available on its internet website the name and level of toxic heavy metals present in each product aggregate of the final infant formula or baby food product. The bill would also require those manufacturers for infant formula or For baby food products for which the federal Food and Drug Administration (FDA) has established an action level, regulatory limit, or tolerance for a certain toxic heavy metal, to include a label on the product that it the bill would require manufacturers to disclose on the product label that the product, as part of a production aggregate, has been tested for that toxic heavy metal. The bill would also require those manufacturers, for infant formula or For baby food products that that, as part of a production aggregate, do not exceed an action level, regulatory limit, or tolerance established by the FDA for a toxic heavy metal, the bill would require manufacturers to include on the label that the product meets FDA guidance. The bill would prohibit a person or entity from selling in the state or manufacturing, delivering, holding, or offering for sale in the state any infant formula baby food that does not comply with these provisions. By creating a new crime, the bill would impose a state-mandated local program.

The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.

This bill would provide that no reimbursement is required by this act for a specified reason.

Existing law, the Sherman Food, Drug, and Cosmetic Law, provides for the regulation of various subjects relating to the manufacturing, processing, labeling, advertising, and sale of food, drugs, and cosmetics, under the administration and enforcement of the State Department of Public Health. A violation of these provisions is punishable as a misdemeanor.

This bill would require an in-state or out-of-state manufacturer of infant formula or baby food for sale or distribution in this state state, beginning on January 1, 2024, to test a representative sample of their final infant formula or baby food product, as defined, for toxic heavy metals, including levels of lead, mercury, cadmium, and arsenic, and to make arsenic. The bill would require a manufacturer, for infant formula or baby food sold, manufactured, delivered, held, or offered for sale in the state, on and after January 1, 2025, to provide specified information disclosures to consumers, including making publicly available on its internet website the name and level of toxic heavy metals present in the final infant formula or baby food product. The bill would also require those manufacturers to, for infant formula or baby food products for which the federal Food and Drug Administration (FDA) has adopted industry guidance for levels of established an action level, regulatory limit, or tolerance for a certain toxic heavy metal, to include a label on the product that it has been tested for that toxic heavy metal and is within the FDA guidance. metal. The bill would also require those manufacturers, for infant formula or baby food products that do not exceed an action level, regulatory limit, or tolerance established by the FDA for a toxic heavy metal, to include on the label that the product meets FDA guidance. The bill would prohibit a person or entity from selling in the state or manufacturing, delivering, holding, or offering for sale in the state any infant formula that does not comply with these provisions. By creating a new crime, the bill would impose a state-mandated local program.

The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.

This bill would provide that no reimbursement is required by this act for a specified reason.

Existing law, the Sherman Food, Drug, and Cosmetic Law, provides for the regulation of various subjects relating to the manufacturing, processing, labeling, advertising, and sale of food, drugs, and cosmetics, under the administration and enforcement of the State Department of Public Health. A violation of these provisions is punishable as a misdemeanor.

This bill would require a an in-state or out-of-state manufacturer of infant formula or baby food for sale or distribution in this state to test their final infant formula or baby food product product, as defined, for toxic heavy metals, including levels of lead, mercury, cadmium, and arsenic, and to make publicly available on its internet website the name and level of toxic heavy metals present in the final infant formula or baby food product. The bill would also require those manufacturers to, for infant formula or baby food products for which the federal Food and Drug Administration (FDA) has adopted industry guidance for levels of a certain toxic heavy metal, include a label on the product that it has been tested for that toxic heavy metal and is within the FDA guidance. By creating a new crime, the bill would impose a state-mandated local program.

The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.

This bill would provide that no reimbursement is required by this act for a specified reason.

Existing law, the Sherman Food, Drug, and Cosmetic Law, provides for the regulation of various subjects relating to the manufacturing, processing, labeling, advertising, and sale of food, drugs, and cosmetics, under the administration and enforcement of the State Department of Public Health. A violation of these provisions is punishable as a misdemeanor.

This bill would require a manufacturer of infant formula or baby food for sale or distribution in this state to test their final infant formula or baby food product for toxic heavy metals, and to make publicly available on its internet website the name and level of toxic heavy metals present in the final infant formula or baby food product. The bill would also require those manufacturers to, for infant formula or baby food products for which the federal Food and Drug Administration (FDA) has adopted industry guidance for levels of a certain toxic heavy metal, include a label on the product that it has been tested for that toxic heavy metal and is within the FDA guidance. By creating a new crime, the bill would impose a state-mandated local program.

The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.

This bill would provide that no reimbursement is required by this act for a specified reason.

CONCURRENCE IN SENATE AMENDMENTS

CSA1 Bill Id:AB 899

Author:(Muratsuchi)

As Amended Ver:September 8, 2023

Majority vote

SUMMARY

Requires, beginning January 1, 2024, a manufacturer of baby food sold or distributed in this state to test a representative sample of each production aggregate of baby food product, at a proficient laboratory meeting specified criteria (including being accredited; using an analytical method; demonstrating proficiency), for toxic elements (meaning arsenic, cadmium, lead, and mercury).

Requires, for the final baby food products sold, manufactured, delivered, held, or offered for sale in the state or and after January 1, 2025, to disclose specified information to consumers, including making publicly available on its internet website the name and level of each toxic element present in each product aggregate of the final baby food product. Requires manufacturers to include on the product label a quick response code that links to a page on the manufacturer's internet website containing testing results for the toxic element and a link to related United States (U.S.) Food and Drug Administration (FDA) guidance, if a product tested for a certain toxic element subject to an action level, regulatory limit, or tolerance established by the FDA.

Senate Amendments

Delete infant formula from the provisions of this bill. Define product shelf life, proficient laboratory, and quick response code. Define toxic elements as arsenic, cadmium, lead, and mercury. Require a manufacturer to provide test results to any authorized agent upon request. Require specified links to the manufacturer's website containing information, including toxic element test results and link to FDA guidance.

COMMENTS

Heavy Metals in Baby Food. On November 6, 2019, following reports alleging high levels of toxic heavy metals in baby foods, the Subcommittee on Economic and Consumer Policy Committee on Oversight and Reform at the U.S. House of Representatives (Subcommittee) requested internal documents and test results from seven of the largest manufactures of baby food in the United States:

1. Nurture, Inc. which sells Happy Family Organics, including baby food products under the brand name HappyBABY;
2. Beech-Nut Nutrition Company;
3. Hain Celestial Group, Inc. which sells baby food products under the brand name Earth's Best Organic;
4. Gerber;
5. Campbell Soup Company, which sells baby food under the name Plum Organics;
6. Walmart Inc.; and,
7. Sprout Foods, Inc. (Sprout Organics Foods).

Four of the companies responded to the subcommittee's requests and produced internal testing policies and test results for ingredients/finished products and documentation about what the companies did with ingredients/finished products that exceeded their internal testing limits. However, Walmart, Campbell, and Sprout Organics Foods refused to cooperate with the subcommittee's investigation.

On February 4, 2021, the Subcommittee released its report (report) which includes the following findings.

1. Commercial baby foods are tainted with significant levels of toxic heavy metals, including arsenic, lead, cadmium, and mercury. Exposure to toxic heavy metals causes permanent decreases in IQ, diminished future economic productivity, and increased risk of future criminal and antisocial behavior in children. Toxic heavy metals endanger infant neurological development and long-term brain function;
2. Internal company standards permit dangerously high levels of toxic heavy metals, and documents revealed that the manufacturers often sold foods that exceeded FDA levels; and,
3. The Subcommittee has grave concerns about baby food products produced by Walmart, Sprouts, and Campbell which refused to cooperate with the Subcommittee, and that their lack of cooperation might obscure the presence of even higher levels of toxic heavy metals in their baby products, compared to their competitors' products.

The Subcommittee also pointed out that corporate policies to test only ingredients, not final products underrepresent the levels of toxic heavy metals in baby foods; naturally occurring toxic heavy metals may not be the only problem causing the unsafe levels of toxic heavy metals in baby foods; rather baby food producers may be adding ingredients that have high levels of toxic heavy metals into their products, such as vitamin/mineral pre-mix; and that only final product testing can measure the true danger posed by baby foods.

According to the Author

This bill protects babies from harmful toxins. In September 2021, the United States House of Representatives Subcommittee on Economic and Consumer Policy released a report detailing concerning levels of heavy metals in baby food products. The report found products from multiple leading baby food producers in violation of FDA heavy metal limits, specifically in regards to arsenic levels in rice products. The Subcommittee recommended that manufacturers be required by the FDA to test final products for heavy metal levels, not just test their ingredients. The Subcommittee also recommended that manufacturers be required to report levels of heavy metals in their products. The author concludes this bill acts on these recommendations and empowers parents by requiring baby formula and baby food manufacturers to test their finished products for heavy metal levels and to make publicly available on their website the name and level of toxic heavy metals present in the final product.

Arguments in Support

The American Academy of Pediatrics, the Center for Food Safety, and the Consumer Attorneys of California write in support that researchers find repeatedly that heavy metals are detrimental to cognitive development. Exposure to heavy metals at an early age has been linked to lower IQs, behavior problems, cardiovascular issues, and attention deficit hyperactivity disorder. This bill acts on recommendations made by the Subcommittee and empowers parents by requiring manufacturers to test for and publicize levels of toxic heavy metals in their baby food and infant formula products.

Arguments in Opposition

The Infant Nutrition Council of America, an association of U.S. manufacturers of infant formulas and toddler milks, has an oppose unless amended position on this bill and requests amendments to be exempt from the provisions of this bill. The Department of Finance is opposed to this bill because it results in General Fund impacts not included in the Administration's spending plan. The FDA's Closer to Zero initiative aims to establish levels for lead, mercury, cadmium, and arsenic. Guidelines are expected to take four or five years to establish and to finalize the first set of regulatory limits. The Closer to Zero initiative is an iterative approach and additional metals may be added if deemed necessary. Finance also notes that, because the language in the bill could be interpreted as an enumeration of toxic heavy metals rather than an exhaustive list, the Department of Public Health (DPH) would need to research additional toxic heavy metals in various food commodities, which may take several years and would subsequently require the promulgation of regulations.

The Department of Finance is opposed to this bill because it results in General Fund impacts not included in the Administration's spending plan. The FDA's Closer to Zero initiative aims to establish levels for lead, mercury, cadmium, and arsenic. Guidelines are expected to take four or five years to establish and to finalize the first set of regulatory limits. The Closer to Zero initiative is an iterative approach and additional metals may be added if deemed necessary. Finance also notes that, because the language in this bill could be interpreted as an enumeration of toxic heavy metals rather than an exhaustive list, DPH would need to research additional toxic heavy metals in various food commodities, which may take several years and would subsequently require the promulgation of regulations.

FISCAL COMMENTS

According to the Senate Appropriations Committee, DPH estimates a range of General Fund costs: If food manufacturers are required to test only the four toxic heavy metals listed in the bill, DPH estimates ongoing General Fund costs of $377,000 for state administration. If food manufacturers are required to test beyond the four toxic heavy metals listed in this bill, which would include additional research and regulation, DPH estimates General Fund costs of $1,131,000 in 2024-25, $781,000 in 2025-26, $781,000 in 2026-27, and $632,000 in 2027-28 and ongoing thereafter for state administration.

VOTES:

ASM HEALTH: 11-1-3

YES: Wood, Waldron, Aguiar-Curry, Arambula, Boerner Horvath, Maienschein, McCarty, Rodriguez, Santiago, Villapudua, Weber

NO: Joe Patterson

ABS, ABST OR NV: Wendy Carrillo, Flora, Vince Fong

ASM ENVIRONMENTAL SAFETY AND TOXIC MATERIALS: 8-0-1

YES: Lee, Arambula, Bauer-Kahan, Connolly, McKinnor, Pacheco, Ta, Zbur

ABS, ABST OR NV: Hoover

ASM APPROPRIATIONS: 14-0-2

YES: Holden, Megan Dahle, Bryan, Calderon, Wendy Carrillo, Mike Fong, Hart, Lowenthal, Mathis, Papan, Pellerin, Sanchez, Weber, Ortega

ABS, ABST OR NV: Dixon, Robert Rivas

ASSEMBLY FLOOR: 53-0-27

YES: Addis, Alvarez, Arambula, Bains, Bauer-Kahan, Bennett, Berman, Boerner, Bonta, Bryan, Calderon, Wendy Carrillo, Cervantes, Connolly, Megan Dahle, Mike Fong, Friedman, Gabriel, Garcia, Gipson, Haney, Hart, Holden, Irwin, Jones-Sawyer, Kalra, Lee, Low, Lowenthal, Maienschein, McCarty, McKinnor, Muratsuchi, Ortega, Pacheco, Petrie-Norris, Quirk-Silva, Ramos, Reyes, Luz Rivas, Robert Rivas, Rodriguez, Santiago, Schiavo, Ting, Valencia, Villapudua, Wallis, Ward, Weber, Wood, Zbur, Rendon

ABS, ABST OR NV: Aguiar-Curry, Alanis, Juan Carrillo, Chen, Davies, Dixon, Essayli, Flora, Vince Fong, Gallagher, Grayson, Hoover, Jackson, Lackey, Mathis, Stephanie Nguyen, Papan, Jim Patterson, Joe Patterson, Pellerin, Blanca Rubio, Sanchez, Soria, Ta, Waldron, Wicks, Wilson

UPDATED

VERSION: September 8, 2023

CONSULTANT: Rosielyn Pulmano / HEALTH / (916) 319-2097 FN: 0002281

 THIRD READING  

Bill No: AB 899

Author: Muratsuchi (D), et al.

Amended: 9/8/23 in Senate

Vote: 21

SENATE HEALTH COMMITTEE: 7-0, 6/28/23

AYES: Eggman, Gonzalez, Limón, Menjivar, Rubio, Wahab, Wiener

NO VOTE RECORDED: Nguyen, Glazer, Grove, Hurtado, Roth

SENATE ENVIRONMENTAL QUALITY COMMITTEE: 4-1, 7/12/23

AYES: Allen, Gonzalez, Menjivar, Skinner

NOES: Dahle

NO VOTE RECORDED: Hurtado, Nguyen

SENATE APPROPRIATIONS COMMITTEE: 5-1, 9/1/23

AYES: Portantino, Ashby, Bradford, Wahab, Wiener

NOES: Jones

NO VOTE RECORDED: Seyarto

ASSEMBLY FLOOR: 53-0, 5/31/23 - See last page for vote

SUBJECT: Food safety: baby food

SOURCE: Author

DIGEST:

This bill requires manufacturers of baby food to test a representative sample of final product, as specified, and to disclose information, as specified, to consumers about the name and levels of toxic elements present in each final product. This bill prohibits the sale, manufacture, or distribution of products in the state that do not comply with the requirements in this bill.

Senate Floor Amendments of 9/8/23 provide further clarification on the requirements for manufacturers to test their products for toxic elements and provide information to consumers, including the frequency of tests, the types of laboratories that can test the product, and information about federal Food and Drug Administration guidance on the named toxic elements and the effect those elements have on children.

ANALYSIS:

Existing law:

1. Enacts the Sherman Food, Drug and Cosmetic Law (Sherman Law), enforced by the California Department of Public Health (CDPH), which provides broad authority for CDPH to enforce food safety requirements, including that food is not adulterated, misbranded, or falsely advertised. Food labeling requirements generally adopt federal food labeling laws as the state requirement, including nutrition labeling and allergen labeling, but CDPH is permitted, by regulation, to adopt additional food labeling regulations. [HSC §109875 et seq., §110380]
2. Prohibits a retail food facility from selling or offering for sale after the “use by” date infant formula or baby food that is required to have this date on its packaging pursuant to federal law. [HSC §114094.5]
3. Defines the following under the Sherman Law:
4. “Label” as a display of written, printed, or graphic matter upon a food, drug, device, or cosmetic or upon its immediate container; and,
5. “Manufacture” as the preparation, compounding, propagation, processing, or fabrication of any food, drug, device, or cosmetic, including repackaging or otherwise changing the container, wrapper, or labeling of any food, drug, device, or cosmetic in furtherance of its distribution. Prohibits the term “manufacture” from including repackaging from a bulk container by a retailer at the time of sale to its ultimate consumer. [HSC §109955, 109970]

This bill:

1. Requires a manufacturer of baby food for sale or distribution in this state to do all of the following:
2. Beginning January 1, 2024, test a representative sample of each “production aggregate,” as defined, of their final baby food product for lead, mercury, cadmium, and arsenic. Permits a manufacturer to test final products before packaging individual units for sale or distribution;
3. Test product at least once per month using a proficient laboratory, as specified.
4. Make publicly available on its website, for the duration of the product shelf life, the name and level of toxic element present in each production aggregate of final product;
5. Provide descriptive information in its website to enable accurate identification of the final product, as specified;
6. Include on a product label a quick response (QR) code or other machine-readable code that links to a page on the manufacturer’s website containing test results for the toxic element; information about the health implications of the toxic element on children; information on the federal Food and Drug Administration (FDA) guidance related to the toxic element; and, a statement that reads: “For information about toxic element testing on this product, scan the QR code.”
7. Prohibits a person or entity to sell, manufacture, deliver, hold, or offer for sale in the state any baby food that does not comply with the requirements in 1) above.
8. Defines “production aggregate” as a quantity of product that is intended to have uniform composition, character, and quality, and is produced according to a master manufacturing order.

Comments

1. Author’s statement. According to the author, this bill protects babies from harmful toxins. In September 2021, the U.S. House of Representatives Subcommittee on Economic and Consumer Policy released a report detailing concerning levels of heavy metals in baby food products. The report found products from multiple leading baby food producers in violation of FDA heavy metal limits, specifically in regards to arsenic levels in rice products. The Subcommittee recommended that manufacturers be required by the FDA to test final products for heavy metal levels, not just test their ingredients. The Subcommittee also recommended that manufacturers be required to report levels of heavy metals in their products. This bill builds upon on these recommendations and empowers parents by requiring baby formula and baby food manufacturers to test their finished products for heavy metal levels and to make publicly available on their website the name and level of toxic heavy metals present in the final product.
2. Congressional report and response. On November 6, 2019, following reports alleging high levels of toxic heavy metals in baby foods, the U.S. House of Representatives Committee on Oversight and Reform Subcommittee on Economic and Consumer Policy requested internal documents and test results from seven of the largest manufactures of baby food in the country: Nurture; Beech-Nut Nutrition Company; Hain Celestial Group, Inc.; Gerber; Campbell Soup Company; Walmart Inc.; and Sprout Foods, Inc. Four of the companies responded to the Subcommittee’s requests and produced internal testing policies and test results for ingredients/finished products and documentation about what the companies did with ingredients/finished products that exceeded their internal testing limits. However, Walmart, Campbell Soup, and Sprout Foods refused to cooperate with the Subcommittee’s investigation. On February 4, 2021, the Subcommittee released its report, “Baby Foods Are Tainted with Dangerous Levels of Arsenic, Lead, Cadmium, and Mercury,” which included the following:
3. Commercial baby foods are tainted with significant levels of toxic heavy metals, including arsenic, lead, cadmium, and mercury. Exposure to toxic heavy metals causes permanent decreases in IQ, diminished future economic productivity, and increased risk of future criminal and antisocial behavior in children. Toxic heavy metals endanger infant neurological development and long-term brain function;
4. Internal company standards permit dangerously high levels of toxic heavy metals, and documents revealed that the manufacturers often sold foods that exceeded the FDA levels; and,
5. The Subcommittee had grave concerns about baby food products produced by Walmart, Sprouts, and Campbell, which refused to cooperate with the Subcommittee, and that their lack of cooperation might obscure the presence of even higher levels of toxic heavy metals in their baby products compared to their competitors’ products.

Following the report, the federal FDA issued a response highlighting that toxic elements are present in the environment and may enter the food supply though soil, water, or air. Because these elements occur in the environment, they currently cannot be completely avoided in the fruits, vegetables, or grains that are the basis for baby foods, juices, and infant cereals. They also cannot be completely avoided by using organic farming practices. The FDA stated that while the report raised important questions, it has been actively working on this issue using a risk-based approach to prioritize and target their efforts. The FDA stated that consumers should know the FDA scientists routinely monitor levels of toxic elements in baby foods, along with other foods consumed in the country’s diet, through the Total Diet Study, and also monitors baby food under the FDA’s compliance program for Toxic Elements in Food and Foodware, Radionuclides in Food, and through targeted sampling assignments. One example is that since 2011, FDA sampling of infant rice cereal has shown that manufacturers have made significant progress in reducing arsenic in infant rice cereal products through selective sourcing and testing of rice and rice-derived ingredients (like rice flour).

1. Closer to Zero Initiative. In April 2021, the FDA announced the Closer to Zero initiative that identifies actions the FDA will take to reduce exposure to toxic elements in foods eaten by babies and young children to the lowest levels possible. The FDA has prioritized babies and young children because their smaller body sizes and metabolism make them more vulnerable to the harmful effects of these contaminants. To meet the goals of Closer to Zero, the FDA will focus on:
2. Research and analysis to include developing new and improved testing methods to measure lower levels of contaminants in food; identifying reference levels for these contaminants to determine levels of concern; conducting surveys on foods commonly eaten by infants and young children to understand variability in concentrations of arsenic, lead, cadmium, and mercury in these foods; and, understanding how nutrients can help protect against the health effects associated with contaminants;
3. Regulation to include establishing action levels, and increasing targeted compliance and enforcement activities; and,
4. Consultation to encourage adoption of agricultural and processing best practices by industry to lower levels of environmental contaminants in agricultural commodities and products.

The FDA points out that reducing levels of contaminants in foods is complicated and multifaceted. It is crucial to ensure that measures taken to limit arsenic, lead, cadmium, and mercury in foods do not have unintended consequences—like eliminating from the marketplace foods that have significant nutritional benefits or reducing the presence of one element while increasing another.

1. FDA’s national strategy. In March 2023, the FDA released “The U.S. FDA’s Immediate National Strategy to Increase the Resiliency of the U.S. Infant Formula Market,” where they highlighted several events that led to the shortage of infant formula in 2022, beginning with information they received between September 2021 and January 2022 about four cases of illness or death in infants who consumed powdered infant formula. A series of Abbott Nutrition facility closures and voluntary recall of certain products contributed to the shortage, which was further compounded by a struggling recovery of the supply chain due to the COVID-19 pandemic and long-standing circumstances that shaped the production of infant formula in the U.S. over the years (infant formula supply is highly concentrated in a small number of manufacturers, which means a small problem can significantly affect overall supply. In 2022, four companies controlled 99% of the infant formula market). The FDA further states that they lacked authority, resources, and staff dedicated to predicting, detecting, and responding to supply chain issues for infant formula, even though they had been requesting authority since 2020. In 2022, the FDA conducted 34 inspections of foreign and domestic facilities that produce infant formula, meeting FDA’s inspection targets for 2022. In November 2022, the FDA released a draft outline of a strategy to prevent Cronobacter sakazakii illnesses associated with the consumption of powdered infant formula. And in March 2023, as part of the prevention strategy work, the FDA sent a letter to the powdered infant formula industry to share current safety information and call on the industry to take prompt action to improve processes and programs. Other actions the FDA has taken include:
2. Significantly expanding and improving a required infant formula online training course for investigators and other appropriate staff to ensure robust inspection;
3. Requiring staff who conduct or support inspections of powdered formula manufacturers to attend an interactive in-person inspection workshop with specific training on conducting infant formula inspections;
4. Creating a new Office of Critical Foods responsible for oversight, coordination, and activities related to critical foods, which is defined as infant formula and medical foods;
5. Expediting review of premarket infant formula submissions if an infant formula shortage has been identified;
6. Working with relevant federal agencies to work together to develop a National Strategy on Infant Formula to address supply chain resiliency; and,
7. Seeking additional authority to require that, among other things, manufacturers report to the FDA final product positive test results for relevant pathogens; conduct more frequent environmental monitoring in their facilities to identify relevant pathogens; and maintain the results of such testing for FDA inspection, either in person or remotely.

FISCAL EFFECT: Appropriation: No Fiscal Com.: Yes Local: Yes

According to the Senate Appropriations Committee:

• If food manufacturers are required to test only the four toxic elements listed in the bill, CDPH estimates ongoing General Fund costs of $377,000 for state administration.
• If food manufacturers are required to test beyond the four toxic elements listed in the bill, which would include additional research and regulation, CDPH estimates General Fund costs of $1,131,000 in 2024-25, $781,000 in 2025-26, $781,000 in 2026-27, and $632,000 in 2027-28 and ongoing thereafter for state administration.

SUPPORT: (Verified 8/31/23)

American Academy of Pediatrics, California

California Chapters of the National Association of Pediatric Nurse Practitioners

California Public Interest Research Group

Center for Food Safety

CleanEarth4Kids.org

Consumer Attorneys of California

Educate. Advocate.

Environmental Working Group

Junior Leagues of California State Public Affairs Committee

OPPOSITION: (Verified 8/31/23)

Consumer Brands Association

Department of Finance

ARGUMENTS IN SUPPORT: Supporters of this bill cite the Congressional report and state that investigators found some companies were not testing their finished food products at all. Instead, manufacturers were testing heavy metal levels in ingredients and using those levels to estimate levels in finished products. This method was determined to understate the toxic heavy metal levels in finished products. Supporters further state that, in June 2021, public health officials in the State of Alaska found that multiple samples of Beech-Nut and Gerber’s infant rice cereals exceeded the FDA’s 100 ppb limits for inorganic arsenic in infant rice cereal. Beech-Nut had tested the rice flour used to make the rice cereal and found arsenic levels below the FDA guidance levels, highlighting the ineffectiveness of ingredient-only testing. Supporters argue researchers find repeatedly that heavy metals are detrimental to cognitive development. Exposure to heavy metals at an early age has been linked to lower IQs, behavior problems, cardiovascular issues, and attention deficit hyperactivity disorder. In 2017, researchers at Duke University studied 565 adults who had their lead levels measured as children. Those with high childhood lead readings had IQ levels 4.25 points lower on average. Supporters state that this bill acts on recommendations made by the Subcommittee on Economic and Consumer Policy and empowers parents by requiring manufacturers to test for and publicize levels of toxic heavy metals in their baby food and infant formula products.

ARGUMENTS IN OPPOSITION: The Consumer Brands Association states they are opposed to this bill as it is currently drafted because they believe it is premature given the ongoing, active FDA guidance development process to determine action levels for lead in food. They state their current regulatory and individual brand processes establish an extensive testing framework that the current FDA guidance will help further inform.

The Department of Finance (DOF) is opposed to this bill arguing that it results in General Fund impacts not included in the Administration’s spending plan. The Federal Drug Administration’s Closer to Zero initiative aims to establish levels for lead, mercury, cadmium, and arsenic. Guidelines are expected to take four or five years to establish and to finalize the first set of regulatory limits. The Closer to Zero initiative is an iterative approach and additional metals may be added if deemed necessary. DOF also notes that because the language in the bill could be interpreted as an enumeration of toxic heavy metals rather than an exhaustive list CDPH would need to research additional toxic heavy metals in various food commodities, which may take several years and would subsequently require the promulgation of regulations.

ASSEMBLY FLOOR: 53-0, 5/31/23

AYES: Addis, Alvarez, Arambula, Bains, Bauer-Kahan, Bennett, Berman, Boerner, Bonta, Bryan, Calderon, Wendy Carrillo, Cervantes, Connolly, Megan Dahle, Mike Fong, Friedman, Gabriel, Garcia, Gipson, Haney, Hart, Holden, Irwin, Jones-Sawyer, Kalra, Lee, Low, Lowenthal, Maienschein, McCarty, McKinnor, Muratsuchi, Ortega, Pacheco, Petrie-Norris, Quirk-Silva, Ramos, Reyes, Luz Rivas, Robert Rivas, Rodriguez, Santiago, Schiavo, Ting, Valencia, Villapudua, Wallis, Ward, Weber, Wood, Zbur, Rendon

NO VOTE RECORDED: Aguiar-Curry, Alanis, Juan Carrillo, Chen, Davies, Dixon, Essayli, Flora, Vince Fong, Gallagher, Grayson, Hoover, Jackson, Lackey, Mathis, Stephanie Nguyen, Papan, Jim Patterson, Joe Patterson, Pellerin, Blanca Rubio, Sanchez, Soria, Ta, Waldron, Wicks, Wilson

Prepared by: Reyes Diaz / HEALTH / (916) 651-4111

9/11/23 13:12:57

**** END ****

 THIRD READING  

Bill No: AB 899

Author: Muratsuchi (D), et al.

Amended: 7/13/23 in Senate

Vote: 21

SENATE HEALTH COMMITTEE: 7-0, 6/28/23

AYES: Eggman, Gonzalez, Limón, Menjivar, Rubio, Wahab, Wiener

NO VOTE RECORDED: Nguyen, Glazer, Grove, Hurtado, Roth

SENATE ENVIRONMENTAL QUALITY COMMITTEE: 4-1, 7/12/23

AYES: Allen, Gonzalez, Menjivar, Skinner

NOES: Dahle

NO VOTE RECORDED: Hurtado, Nguyen

SENATE APPROPRIATIONS COMMITTEE: 5-1, 9/1/23

AYES: Portantino, Ashby, Bradford, Wahab, Wiener

NOES: Jones

NO VOTE RECORDED: Seyarto

ASSEMBLY FLOOR: 53-0, 5/31/23 - See last page for vote

SUBJECT: Food safety: baby food

SOURCE: Author

DIGEST:

This bill requires in-state and out-of-state manufacturers of baby food to test a representative sample of final product, as specified, and to disclose information, as specified, to consumers about the name and levels of toxic heavy metals present in each final product, stating that the product meets federal guidance for that toxic heavy metal. This bill prohibits the sale, manufacture, or distribution of products in the state that do not comply with the requirements in this bill.

ANALYSIS:

Existing law:

1. Enacts the Sherman Food, Drug and Cosmetic Law (Sherman Law), enforced by the California Department of Public Health (CDPH), which provides broad authority for CDPH to enforce food safety requirements, including that food is not adulterated, misbranded, or falsely advertised. Food labeling requirements generally adopt federal food labeling laws as the state requirement, including nutrition labeling and allergen labeling, but CDPH is permitted, by regulation, to adopt additional food labeling regulations. [HSC §109875 et seq., §110380]
2. Prohibits a retail food facility from selling or offering for sale after the “use by” date infant formula or baby food that is required to have this date on its packaging pursuant to federal law. [HSC §114094.5]
3. Defines the following under the Sherman Law:
4. “Label” as a display of written, printed, or graphic matter upon a food, drug, device, or cosmetic or upon its immediate container; and,
5. “Manufacture” as the preparation, compounding, propagation, processing, or fabrication of any food, drug, device, or cosmetic, including repackaging or otherwise changing the container, wrapper, or labeling of any food, drug, device, or cosmetic in furtherance of its distribution. Prohibits the term “manufacture” from including repackaging from a bulk container by a retailer at the time of sale to its ultimate consumer. [HSC §109955, 109970]

This bill:

1. Requires an in-state or out-of-state manufacturer of baby food for sale or distribution in this state to do all of the following:
2. Beginning January 1, 2024, test a representative sample of each “production aggregate,” as defined, of their final baby food product for toxic heavy metals, including levels of lead, mercury, cadmium, and arsenic. Permits a manufacturer to test final products before packaging individual units for sale or distribution;
3. Disclose product information, after January 1, 2025, for baby food products sold, manufactured, delivered, held, or offered for sale in the state to consumers by making publicly available on its website the name and level of toxic heavy metals present in each production aggregate of their final baby food product;
4. Include on a product label, after January 1, 2025, a quick response (QR) code or other machine-readable code that links to a page on the manufacturer’s website containing test results for the toxic heavy metal; information about the health implications of the toxic heavy metal on children; information on the federal Food and Drug Administration (FDA) guidance related to the toxic heavy metal; and, a statement that reads: “For information about toxic heavy metal testing on this product, scan the QR code.”
5. Prohibits a person or entity to sell, manufacture, deliver, hold, or offer for sale in the state any baby food that does not comply with the requirements in 1) above.
6. Defines “production aggregate” as a quantity of product that is intended to have uniform composition, character, and quality, and is produced according to a master manufacturing order.

Comments

1. Author’s statement. According to the author, this bill protects babies from harmful toxins. In September 2021, the U.S. House of Representatives Subcommittee on Economic and Consumer Policy released a report detailing concerning levels of heavy metals in baby food products. The report found products from multiple leading baby food producers in violation of FDA heavy metal limits, specifically in regards to arsenic levels in rice products. The Subcommittee recommended that manufacturers be required by the FDA to test final products for heavy metal levels, not just test their ingredients. The Subcommittee also recommended that manufacturers be required to report levels of heavy metals in their products. This bill builds upon on these recommendations and empowers parents by requiring baby formula and baby food manufacturers to test their finished products for heavy metal levels and to make publicly available on their website the name and level of toxic heavy metals present in the final product.
2. Congressional report and response. On November 6, 2019, following reports alleging high levels of toxic heavy metals in baby foods, the U.S. House of Representatives Committee on Oversight and Reform Subcommittee on Economic and Consumer Policy requested internal documents and test results from seven of the largest manufactures of baby food in the country: Nurture; Beech-Nut Nutrition Company; Hain Celestial Group, Inc.; Gerber; Campbell Soup Company; Walmart Inc.; and Sprout Foods, Inc. Four of the companies responded to the Subcommittee’s requests and produced internal testing policies and test results for ingredients/finished products and documentation about what the companies did with ingredients/finished products that exceeded their internal testing limits. However, Walmart, Campbell Soup, and Sprout Foods refused to cooperate with the Subcommittee’s investigation. On February 4, 2021, the Subcommittee released its report, “Baby Foods Are Tainted with Dangerous Levels of Arsenic, Lead, Cadmium, and Mercury,” which included the following:
3. Commercial baby foods are tainted with significant levels of toxic heavy metals, including arsenic, lead, cadmium, and mercury. Exposure to toxic heavy metals causes permanent decreases in IQ, diminished future economic productivity, and increased risk of future criminal and antisocial behavior in children. Toxic heavy metals endanger infant neurological development and long-term brain function;
4. Internal company standards permit dangerously high levels of toxic heavy metals, and documents revealed that the manufacturers often sold foods that exceeded the FDA levels; and,
5. The Subcommittee had grave concerns about baby food products produced by Walmart, Sprouts, and Campbell, which refused to cooperate with the Subcommittee, and that their lack of cooperation might obscure the presence of even higher levels of toxic heavy metals in their baby products compared to their competitors’ products.

Following the report, the federal FDA issued a response highlighting that toxic elements are present in the environment and may enter the food supply though soil, water, or air. Because these elements occur in the environment, they currently cannot be completely avoided in the fruits, vegetables, or grains that are the basis for baby foods, juices, and infant cereals. They also cannot be completely avoided by using organic farming practices. The FDA stated that while the report raised important questions, it has been actively working on this issue using a risk-based approach to prioritize and target their efforts. The FDA stated that consumers should know the FDA scientists routinely monitor levels of toxic elements in baby foods, along with other foods consumed in the country’s diet, through the Total Diet Study, and also monitors baby food under the FDA’s compliance program for Toxic Elements in Food and Foodware, Radionuclides in Food, and through targeted sampling assignments. One example is that since 2011, FDA sampling of infant rice cereal has shown that manufacturers have made significant progress in reducing arsenic in infant rice cereal products through selective sourcing and testing of rice and rice-derived ingredients (like rice flour).

1. Closer to Zero Initiative. In April 2021, the FDA announced the Closer to Zero initiative that identifies actions the FDA will take to reduce exposure to toxic elements in foods eaten by babies and young children to the lowest levels possible. The FDA has prioritized babies and young children because their smaller body sizes and metabolism make them more vulnerable to the harmful effects of these contaminants. To meet the goals of Closer to Zero, the FDA will focus on:
2. Research and analysis to include developing new and improved testing methods to measure lower levels of contaminants in food; identifying reference levels for these contaminants to determine levels of concern; conducting surveys on foods commonly eaten by infants and young children to understand variability in concentrations of arsenic, lead, cadmium, and mercury in these foods; and, understanding how nutrients can help protect against the health effects associated with contaminants;
3. Regulation to include establishing action levels, and increasing targeted compliance and enforcement activities; and,
4. Consultation to encourage adoption of agricultural and processing best practices by industry to lower levels of environmental contaminants in agricultural commodities and products.

The FDA points out that reducing levels of contaminants in foods is complicated and multifaceted. It is crucial to ensure that measures taken to limit arsenic, lead, cadmium, and mercury in foods do not have unintended consequences—like eliminating from the marketplace foods that have significant nutritional benefits or reducing the presence of one element while increasing another.

1. FDA’s national strategy. In March 2023, the FDA released “The U.S. FDA’s Immediate National Strategy to Increase the Resiliency of the U.S. Infant Formula Market,” where they highlighted several events that led to the shortage of infant formula in 2022, beginning with information they received between September 2021 and January 2022 about four cases of illness or death in infants who consumed powdered infant formula. A series of Abbott Nutrition facility closures and voluntary recall of certain products contributed to the shortage, which was further compounded by a struggling recovery of the supply chain due to the COVID-19 pandemic and long-standing circumstances that shaped the production of infant formula in the U.S. over the years (infant formula supply is highly concentrated in a small number of manufacturers, which means a small problem can significantly affect overall supply. In 2022, four companies controlled 99% of the infant formula market). The FDA further states that they lacked authority, resources, and staff dedicated to predicting, detecting, and responding to supply chain issues for infant formula, even though they had been requesting authority since 2020. In 2022, the FDA conducted 34 inspections of foreign and domestic facilities that produce infant formula, meeting FDA’s inspection targets for 2022. In November 2022, the FDA released a draft outline of a strategy to prevent Cronobacter sakazakii illnesses associated with the consumption of powdered infant formula. And in March 2023, as part of the prevention strategy work, the FDA sent a letter to the powdered infant formula industry to share current safety information and call on the industry to take prompt action to improve processes and programs. Other actions the FDA has taken include:
2. Significantly expanding and improving a required infant formula online training course for investigators and other appropriate staff to ensure robust inspection;
3. Requiring staff who conduct or support inspections of powdered formula manufacturers to attend an interactive in-person inspection workshop with specific training on conducting infant formula inspections;
4. Creating a new Office of Critical Foods responsible for oversight, coordination, and activities related to critical foods, which is defined as infant formula and medical foods;
5. Expediting review of premarket infant formula submissions if an infant formula shortage has been identified;
6. Working with relevant federal agencies to work together to develop a National Strategy on Infant Formula to address supply chain resiliency; and,
7. Seeking additional authority to require that, among other things, manufacturers report to the FDA final product positive test results for relevant pathogens; conduct more frequent environmental monitoring in their facilities to identify relevant pathogens; and maintain the results of such testing for FDA inspection, either in person or remotely.

FISCAL EFFECT: Appropriation: No Fiscal Com.: Yes Local: Yes

According to the Senate Appropriations Committee, CDPH estimates a range of General Fund costs:

• If food manufacturers are required to test only the four toxic heavy metals listed in the bill, CDPH estimates ongoing General Fund costs of $377,000 for state administration.
• If food manufacturers are required to test beyond the four toxic heavy metals listed in the bill, which would include additional research and regulation, CDPH estimates General Fund costs of $1,131,000 in 2024-25, $781,000 in 2025-26, $781,000 in 2026-27, and $632,000 in 2027-28 and ongoing thereafter for state administration.

SUPPORT: (Verified 8/31/23)

American Academy of Pediatrics, California

California Chapters of the National Association of Pediatric Nurse Practitioners

California Public Interest Research Group

Center for Food Safety

CleanEarth4Kids.org

Consumer Attorneys of California

Educate. Advocate.

Environmental Working Group

Junior Leagues of California State Public Affairs Committee

OPPOSITION: (Verified 8/31/23)

Consumer Brands Association

Department of Finance

ARGUMENTS IN SUPPORT: Supporters of this bill cite the Congressional report and state that investigators found some companies were not testing their finished food products at all. Instead, manufacturers were testing heavy metal levels in ingredients and using those levels to estimate levels in finished products. This method was determined to understate the toxic heavy metal levels in finished products. Supporters further state that, in June 2021, public health officials in the State of Alaska found that multiple samples of Beech-Nut and Gerber’s infant rice cereals exceeded the FDA’s 100 ppb limits for inorganic arsenic in infant rice cereal. Beech-Nut had tested the rice flour used to make the rice cereal and found arsenic levels below the FDA guidance levels, highlighting the ineffectiveness of ingredient-only testing. Supporters argue researchers find repeatedly that heavy metals are detrimental to cognitive development. Exposure to heavy metals at an early age has been linked to lower IQs, behavior problems, cardiovascular issues, and attention deficit hyperactivity disorder. In 2017, researchers at Duke University studied 565 adults who had their lead levels measured as children. Those with high childhood lead readings had IQ levels 4.25 points lower on average. Supporters state that this bill acts on recommendations made by the Subcommittee on Economic and Consumer Policy and empowers parents by requiring manufacturers to test for and publicize levels of toxic heavy metals in their baby food and infant formula products.

ARGUMENTS IN OPPOSITION: The Consumer Brands Association states they are opposed to this bill as it is currently drafted because they believe it is premature given the ongoing, active FDA guidance development process to determine action levels for lead in food. They state their current regulatory and individual brand processes establish an extensive testing framework that the current FDA guidance will help further inform.

The Department of Finance (DOF) is opposed to this bill because it results in General Fund impacts not included in the Administration’s spending plan. The Federal Drug Administration’s Closer to Zero initiative aims to establish levels for lead, mercury, cadmium, and arsenic. Guidelines are expected to take four or five years to establish and to finalize the first set of regulatory limits. The Closer to Zero initiative is an iterative approach and additional metals may be added if deemed necessary. DOF also notes that because the language in the bill could be interpreted as an enumeration of toxic heavy metals rather than an exhaustive list CDPH would need to research additional toxic heavy metals in various food commodities, which may take several years and would subsequently require the promulgation of regulations.

ASSEMBLY FLOOR: 53-0, 5/31/23

AYES: Addis, Alvarez, Arambula, Bains, Bauer-Kahan, Bennett, Berman, Boerner, Bonta, Bryan, Calderon, Wendy Carrillo, Cervantes, Connolly, Megan Dahle, Mike Fong, Friedman, Gabriel, Garcia, Gipson, Haney, Hart, Holden, Irwin, Jones-Sawyer, Kalra, Lee, Low, Lowenthal, Maienschein, McCarty, McKinnor, Muratsuchi, Ortega, Pacheco, Petrie-Norris, Quirk-Silva, Ramos, Reyes, Luz Rivas, Robert Rivas, Rodriguez, Santiago, Schiavo, Ting, Valencia, Villapudua, Wallis, Ward, Weber, Wood, Zbur, Rendon

NO VOTE RECORDED: Aguiar-Curry, Alanis, Juan Carrillo, Chen, Davies, Dixon, Essayli, Flora, Vince Fong, Gallagher, Grayson, Hoover, Jackson, Lackey, Mathis, Stephanie Nguyen, Papan, Jim Patterson, Joe Patterson, Pellerin, Blanca Rubio, Sanchez, Soria, Ta, Waldron, Wicks, Wilson

Prepared by: Reyes Diaz / HEALTH / (916) 651-4111

9/2/23 16:58:16

**** END ****

SENATE COMMITTEE ON APPROPRIATIONS

Senator Anthony Portantino, Chair

2023 - 2024 Regular Session

AB 899 (Muratsuchi) - Food safety: baby food

Bill Summary:

AB 899 would require an in-state or out-of-state manufacturer of baby food for sale or distribution in this state to test samples for toxic heavy metals and to disclose specified information to consumers.

Fiscal Impact:

The California Department of Public Health (CDPH) estimates a range of General Fund costs:

• If food manufacturers are required to test only the four toxic heavy metals listed in the bill, CDPH estimates ongoing General Fund costs of $377,000 for state administration.
• If food manufacturers are required to test beyond the four toxic heavy metals listed in the bill, which would include additional research and regulation, CDPH estimates General Fund costs of $1,131,000 in 2024-25, $781,000 in 2025-26, $781,000 in 2026-27, and $632,000 in 2027-28 and ongoing thereafter for state administration.

Background:

The state’s Sherman Food, Drug and Cosmetic Law provides broad authority for CDPH to enforce food safety requirements, including that food is not adulterated, misbranded, or falsely advertised. Food labeling requirements generally adopt federal food labeling laws as the state requirement, including nutrition labeling and allergen labeling, but CDPH is permitted by regulation to adopt additional food labeling regulations.

Current law requires CDPH to review all changes to the federal definition of infant formula before those changes are incorporated by reference to the Sherman Law, as specified. Current state law also prohibits a retail food facility from selling or offering for sale after the “use by” date infant formula or baby food that is required to have this date on its packaging pursuant to federal law.

Proposed Law:

Specific provisions of the bill would:

• Require an in-state or out-of-state manufacturer of baby food for sale or distribution in this state to comply with the following:
  • Beginning on January 1, 2024, test a representative sample of each production aggregate of the manufacturer’s final baby food product for toxic heavy metals, including levels of lead, mercury, cadmium, and arsenic.
  • For baby food products sold, manufactured, delivered, held, or offered for sale in the state on and after January 1, 2025, disclose product information to consumers, as specified.
• Prohibit a person or entity from selling in the state or manufacturing, delivering, holding, or offering for sale in the state any baby food that does not comply with these requirements.

-- END --

SENATE COMMITTEE ON APPROPRIATIONS

Senator Anthony Portantino, Chair

2023 - 2024 Regular Session

AB 899 (Muratsuchi) - Food safety: baby food

Bill Summary:

AB 899 would require an in-state or out-of-state manufacturer of baby food for sale or distribution in this state to test samples for toxic heavy metals and to disclose specified information to consumers.

Fiscal Impact:

The California Department of Public Health (CDPH) estimates a range of General Fund costs:

• If food manufacturers are required to test only the four toxic heavy metals listed in the bill, CDPH estimates ongoing General Fund costs of $377,000 for state administration.
• If food manufacturers are required to test beyond the four toxic heavy metals listed in the bill, which would include additional research and regulation, CDPH estimates General Fund costs of $1,131,000 in 2024-25, $781,000 in 2025-26, $781,000 in 2026-27, and $632,000 in 2027-28 and ongoing thereafter for state administration.

Background:

The state’s Sherman Food, Drug and Cosmetic Law provides broad authority for CDPH to enforce food safety requirements, including that food is not adulterated, misbranded, or falsely advertised. Food labeling requirements generally adopt federal food labeling laws as the state requirement, including nutrition labeling and allergen labeling, but CDPH is permitted by regulation to adopt additional food labeling regulations.

Current law requires CDPH to review all changes to the federal definition of infant formula before those changes are incorporated by reference to the Sherman Law, as specified. Current state law also prohibits a retail food facility from selling or offering for sale after the “use by” date infant formula or baby food that is required to have this date on its packaging pursuant to federal law.

Proposed Law:

Specific provisions of the bill would:

• Require an in-state or out-of-state manufacturer of baby food for sale or distribution in this state to comply with the following:
  • Beginning on January 1, 2024, test a representative sample of each production aggregate of the manufacturer’s final baby food product for toxic heavy metals, including levels of lead, mercury, cadmium, and arsenic.
  • For baby food products sold, manufactured, delivered, held, or offered for sale in the state on and after January 1, 2025, disclose product information to consumers, as specified.
• Prohibit a person or entity from selling in the state or manufacturing, delivering, holding, or offering for sale in the state any baby food that does not comply with these requirements.

-- END --

SENATE COMMITTEE ON ENVIRONMENTAL QUALITY

Senator Allen, Chair

2023 - 2024 Regular

SUBJECT: Food safety: baby food

DIGEST: Requires an in-state or out-of-state manufacturer of baby food for sale or distribution in California to test their final baby food product for toxic heavy metals, including lead, mercury, cadmium, and arsenic; post on the manufacturer's website the name and level of toxic heavy metals present in their product; and disclose on a product label that the product has been tested for a toxic heavy metal if an action level, regulatory limit, or tolerance level has been established by the federal Food and Drug Administration (FDA).

ANALYSIS:

Existing law:

1. Establishes the state Sherman Food, Drug, and Cosmetics Law (Sherman Law), administered by the California Department of Public Health (CDPH), which regulates the manufacture, packaging, labeling, and advertising of food, drugs, and cosmetics. (Health and Safety Code (HSC) § 109875-111929.4)
   
2. Authorizes the establishment of a tolerance, regulatory limit, or action level for an added poisonous or deleterious substance in food, as specified. (21 CFR § 109.4)
   
3. Prohibits, under the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65), a person in the course of doing business from knowingly and intentionally exposing any individual to a chemical known to the state to cause cancer or reproductive toxicity without first giving clear and reasonable warning to such individual. (HSC § 25249.6)
4. Authorizes, under Proposition 65, a warning to be provided by general methods, such as labels on consumer products, posting of notices, placing notices in public news media, and the like, provided that the warning is clear and reasonable; provides that regulations implementing Proposition 65 shall, to the extent practicable, place the obligation to provide any warning materials on the producer or packager rather than on the retail seller, except where the retail seller itself is responsible for introducing a chemical known to the state to cause cancer or reproductive toxicity. (HSC § 25249.11(f))

This bill:

1. Establishes the following definitions, for the purposes of the bill:
2. "Baby food" means food packaged in jars, pouches, tubs, and boxes represented or purported to be specifically for babies and young children less than two years old.
3. "Final baby food product" means the finished product of baby food and not the constituent ingredients of baby food.
4. "Production aggregate" means a quantity of product that is intended to have uniform composition, character, and quality, and is produced according to a master manufacturing order.  
5. "Representative sample" means a sample that consists of a number of units that are drawn based on rational criteria, such as random sampling, and intended to ensure that the sample accurately portrays the material being sampled.
6. Requires an in-state or out-of-state manufacturer of baby food for sale or distribution in California to do all of the following:
7. Test, beginning on January 1, 2024, a representative sample of each production aggregate of their final baby food product for toxic heavy metals, including levels of lead, mercury, cadmium, and arsenic. Manufacturers are authorized to test their final baby food product before individual units are packaged for sale or distribution;
8. Disclose, on and after January 1, 2025, product information to consumers for baby food products sold, manufactured, delivered, held, or offered for sale in the state by doing all of the following:
9. Make publicly available on the manufacturer's website the name and level of toxic heavy metals present in each production aggregate of their final baby food product.
10. Disclose on a product label that the product is a part of a production aggregate that has been tested for a toxic heavy metal that the FDA has established an action level, regulatory limit, or tolerance for.
11. Include a product label showing that the product meets FDA guidance for a toxic metal, if the production aggregate that the product is a part of does not exceed an action level, regulatory limit, or tolerance established by the FDA for that heavy metal.
12. Prohibit a person or entity from selling, manufacturing, delivering, holding, or offering for sale in the state any baby food that does not comply with the requirements of the bill.

Background

1. Regulation of heavy metals in baby food. Both federal and state laws regulate contaminants in consumer products; these laws have, to varying degrees, been used to regulate contaminants specifically in baby food. Two major bodies of law—the federal FD&C and Proposition 65—and their use in regulating heavy metals in baby are described further below.

The FDA and the federal Food, Drug, and Cosmetics Act (FD&C): Under the FD&C, the FDA is authorized to establish tolerances, regulatory limits, or action levels for contaminants in food. Exceedance of established regulatory limits or action levels can be used to deem a food "adulterated," which gives the FDA the authority to initiate enforcement actions that can range from issuing a letter notifying the individual or firm of a violation and requesting correction, to criminal prosecution of the individual or firm. The FDA maintains that while action levels are a useful tool for driving down contaminant levels in foods, the agency does not need an action level for a contaminant to take enforcement action. By law, food manufacturers and processors have a responsibility to implement preventive controls as needed to minimize or prevent exposure to chemical hazards—including lead, arsenic, cadmium, and mercury. However, in light of results from a Congressional investigation of heavy metals in baby food (described below), it is unclear to what extent the FDA is using its authority to hold manufacturers accountable for heavy metals in their products. As of 2023, the FDA has used its authority under the FD&C to establish contaminant standards for only a handful of foods, only one of which is a type of baby food.

In April 2021, the FDA announced the Closer to Zero initiative, which identifies actions the FDA will take to reduce exposure to lead, arsenic, cadmium, and mercury in foods eaten by babies and young children to the lowest levels possible. The FDA has prioritized babies and young children because their smaller body sizes and metabolism make them more vulnerable to the harmful effects of contaminants. To meet the goals of Closer to Zero, the FDA will focus on:

• Research and analysis, to include developing new and improved testing methods to measure lower levels of contaminants in food;
• Regulation, to include establishing action levels, increasing targeted compliance and enforcement activities, and monitoring levels over time to determine possible adjustments to action levels; and,
• Consultation, to include encouraging adoption of agricultural and processing best practices by industry to lower levels of environmental contaminants in agricultural commodities and products.

In 2023, the FDA released its first set of draft guidance under the Closer to Zero initiative. The draft guidance lists potential action levels for lead in baby foods. The FDA notes that “FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe FDA’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in FDA guidances means that something is suggested or recommended, but not required."

California's Proposition 65: In 1986, California voters approved a ballot initiative, the Safe Drinking Water and Toxic Enforcement Act of 1986, commonly referred to as Proposition 65, to address concerns that "hazardous chemicals pose a serious potential threat to their health and well-being, [and] that state government agencies have failed to provide them with adequate protection…" Proposition 65 requires the state to publish a list of chemicals known to cause cancer or birth defects or other reproductive harm. The Office of Environmental Health Hazard Assessment (OEHHA) administers the Proposition 65 program, including an evaluation of all currently available scientific information on substances considered for placement on the Proposition 65 list.

OEHHA has established safe harbor levels for many of the chemicals on the Proposition 65 list. Exposure levels that are below these safe harbor levels are exempt from the requirements of Proposition 65. The safe harbor levels for the heavy metals specified in AB 899 are 10 μg/day for arsenic, 4.1 μg/day for cadmium, and 15 μg/day for lead and lead compounds. No safe harbor level has been specified for mercury.

In 2018, the Attorney General and ten district attorneys filed a lawsuit against Perrigo Company after testing showed that the company's infant and toddler formula products contained levels of lead that exceeded the Proposition 65 warning threshold. In 2022, the Attorney General announced a settlement with Perrigo Company that sets maximum lead levels of 5-7 parts per billion (ppb) for most of these products, levels that are much lower than applicable guidance levels established for this type of product by any U.S. regulatory authority.

1. Heavy metals in baby food. Several reports and investigations have documented the presence of heavy metals in baby food Baby food: On November 6, 2019, the Subcommittee on Economic and Consumer Policy (Subcommittee; part of the Committee on Oversight and Reform at the U.S. House of Representatives) acted on reports alleging high levels of toxic heavy metals in baby foods by requesting internal documents and test results from seven of the largest manufactures of baby food in the U.S. The manufacturers were: Nurture, Inc., Beech-Nut Nutrition Company; Hain Celestial Group, Inc., Gerber; Campbell Soup Company; Walmart Inc.; and, Sprout Foods, Inc.

Four of the companies responded to the subcommittee’s requests and produced internal testing policies and test results for ingredients/finished products and documentation about what the companies did with ingredients/finished products that exceeded their internal testing limits. However, Walmart, Campbell, and Sprout Organics Foods refused to cooperate with the subcommittee’s investigation.

On February 4, 2021, the Subcommittee released the report, "Baby foods are tainted with dangerous levels of arsenic, lead, cadmium, and mercury," which details findings from its investigation. Findings include:

• • Commercial baby foods are tainted with significant levels of toxic heavy metals, including arsenic, lead, cadmium, and mercury. Exposure to toxic heavy metals causes permanent decreases in IQ, diminished future economic productivity, and increased risk of future criminal and antisocial behavior. Toxic heavy metals endanger infant neurological development and long-term brain function;
    
  • Arsenic, lead, and cadmium were present in baby foods made by all of the responding companies, and mercury was detected in baby food of the only responding company that tested for it. Nurture sold finished baby food products containing as much as 10 ppb mercury, Beech-Nut and Hain did not test for mercury, and Gerber rarely tested for mercury in its baby foods;
  • Internal company standards permit dangerously high levels of toxic heavy metals. Documents revealed that the manufacturers have often sold foods that exceeded FDA levels (where levels have been established) and that have, in some cases, even exceeded manufacturers' own internal standards. In some instances, manufacturers' internal standards were higher than the FDA limit. For example, although the FDA has a standard of 100 ppb inorganic arsenic in infant rice cereal, Nurture set its internal standard for that product 15% higher than the FDA limit;
    
  • The Subcommittee expressed grave concerns about baby food products produced by Walmart, Sprouts, and Campbell, which refused to cooperate with the Subcommittee, and that their lack of cooperation might obscure the presence of even higher levels of toxic heavy metals in their baby products, compared to their competitors’ products; and,
  • In 2019, industry shared information with federal regulators, but not the general public, that revealed corporate policies to test only ingredients, not final products, a practice that may underrepresent the levels of toxic heavy metals in baby foods. The information also revealed that baby food producers may be adding ingredients that have high levels of toxic heavy metals into their products, such as vitamin/mineral pre-mix.

Based on its findings, the Subcommittee issued the recommendations listed below. The first two—mandatory testing and labeling—are consistent with requirements established in AB 899.

• Mandatory testing: Baby food manufacturers should be required by the FDA to test their finished products for toxic heavy metals, not just their ingredients;
• Labeling: Manufacturers should be required by the FDA to report levels of toxic heavy metals on food labels;
• Voluntary phase-out of toxic ingredients: Manufacturers should voluntarily find substitutes for ingredients that are high in toxic heavy metals, or phase out ingredients that have high amounts of toxic heavy metals, such as rice;
• Standards: The FDA should set maximum levels of toxic heavy metals permitted in baby foods; and,
• Parental vigilance. Parents should avoid baby foods that contain ingredients testing high in toxic heavy metals, such as rice products.

Comments

1. Purpose of Bill. According to the author, "AB 899 protects babies from harmful toxins. In September 2021, the US House of Representatives Subcommittee on Economic and Consumer Policy released a report detailing concerning levels of heavy metals in baby food products. The report found products from multiple leading baby food producers in violation of FDA heavy metal limits, specifically in regards to arsenic levels in rice products.
   

“The Subcommittee recommended that manufacturers be required by the FDA to test final products for heavy metal levels, not just test their ingredients. The Subcommittee also recommended that manufacturers be required to report levels of heavy metals in their products.

“AB 899 acts on these recommendations and empowers parents by requiring baby formula and baby food manufacturers to test their finished products for heavy metal levels and to make publicly available on their website the name and level of toxic heavy metals present in the final product.”

1. Testing and posting adds important transparency. AB 899 requires manufacturers of baby food to test their final baby food product for toxic heavy metals, including lead, mercury, cadmium, and arsenic. The bill also requires manufacturers to post on their websites the names and levels of toxic heavy metals present in their product. The bill's testing requirements act on recommendations made by the United States House of Representatives Subcommittee on Economic and Consumer Policy, and could help provide a level of transparency about heavy metal contamination in baby food that is not currently available parents and caregivers.
2. Proposed changes to the labeling requirement. AB 899 would require a baby food manufacturer to disclose on a product label that the product has been tested, as part of a production aggregate, for a toxic heavy metal subject to an action level, regulatory limit, or tolerance established by FDA, and, if applicable, is within FDA guidance for that metal. Of the four toxic heavy metals specified in this bill, only lead has a FDA draft action level for baby food. Draft action levels and guidance for arsenic and cadmium are expected to be developed some time in 2024. The FDA has not yet specified a date for the development of draft guidance or action levels for mercury.
   
   The opposition notes that this labeling requirement would be difficult for manufacturers to comply with. According to the Consumer Brands Association, “AB 899 would require nearly constant changes to labels since every label would have to be updated with the heavy metal testing results from production batches. Given the lengthy time it takes to implement label changes, this would be very difficult for manufacturers.”

Given these concerns, the committee and author may wish to amend the bill to delete the existing label requirements instead require baby food products that are tested for a toxic heavy metal subject to an action level, regulatory limit or tolerance established by FDA include on the product label both of the following:

• 1. A quick response (QR) code that links to a page on the manufacture’s internet website containing all of the following information: test results for the toxic heavy metal; information about the health implications of such metal on children; and information on the FDA guidance related to the toxic heavy metal.
  2. A statement that reads “For information about toxic heavy metal testing on this product, scan the QR code.”

The committee also may wish to direct the author to engage with stakeholders to further refine the bill’s labeling and internet posting provisions and keep committee staff appraised of the progress of those discussions.

1. Technical amendment. Senate Health Committee amendments deleted infant formula from the bill. A technical amendment is needed to clarify that the definition of “baby food” does not include infant formula.
2. Committee Amendments. Staff recommends the committee adopt the bolded amendments contained in comment 3 and 4 above.

Related/Prior Legislation

AB 418 (Gabriel, 2023) prohibits, commencing January 1, 2025, a person or entity from manufacturing, selling, delivering, distributing, holding, or offering for sale, in commerce a food product that contains any of the following substances: brominated vegetable oil, potassium bromate, propylparaben, red dye 3, and titanium dioxide. This bill is currently pending before this committee.

AB 100 (Holden, Chapter 692, Statutes of 2021) requires, commencing January 1, 2023, manufacturer compliance with a specified lower lead leaching standard for faucets and other end point devices used for providing drinking water, and prohibits all sales of such products that do not meet the new standard beginning July 1, 2023. Requires labeling of products that comply with the definition of "lead free" to indicate compliance in an easily identifiable manner.

DOUBLE REFERRAL:

This measure was heard in Senate Health Committee on June 28, 2023, and passed out of committee with a vote of 7-0.

SOURCE:

Author

SUPPORT:

Center for Food Safety; the
Consumer Attorneys of California
Environmental Working Group

OPPOSITION:

Consumer Brands Association

Infant Nutrition Council of America

ARGUMENTS IN SUPPORT:

According to the American Academy of Pediatrics, California, "In September 2021, the US House of Representatives Subcommittee on Economic and Consumer Policy released a report detailing concerning levels of heavy metals in baby food products. The report found products from multiple leading baby food producers in violation of FDA heavy metal limits, specifically in regard to arsenic levels in rice products.

While compiling the 2021 report, investigators found that some companies were not testing their finished food products at all. Instead, manufacturers were testing heavy metal levels in ingredients and using those levels to estimate levels in finished products. This method was determined to understate the toxic heavy metal levels in finished products. The Subcommittee recommended that manufacturers be required to test their final products for heavy metal levels, not just their ingredients. The Subcommittee also recommended that manufacturers be required to report levels of heavy metals in their products.

“Researchers find repeatedly that heavy metals are detrimental to cognitive development. Exposure to heavy metals at an early age has been linked to lower IQs, behavior problems, cardiovascular issues, and attention deficit hyperactivity disorder…AB 899 acts on recommendations made by the Subcommittee on Economic and Consumer Policy and empowers parents by requiring manufacturers to test for and publicize levels of toxic heavy metals in their baby food and infant formula products."

ARGUMENTS IN OPPOSITION:

According to the Consumer Brands Association, “We believe AB 899 is premature given the ongoing, active FDA guidance development process to determine action levels for lead in food. Consumer Brands applauds the work FDA is currently doing under President Biden’s Closer to Zero Action Plan for Reducing Childhood Exposure to Contaminants from Foods, and this Spring, we provided detailed comments on FDA’s draft guidance on action levels for lead in baby food. Consumer Brands supports uniform, workable and durable regulatory frameworks informed by risk-based science, promoting consumer choice and building consumer trust across the sectors we represent. We believe it would be counter-productive and confusing to consumers for California to establish state requirements around public disclosure and consumer labeling before FDA has established timeframes and measures for assessing the industry’s progress toward meeting federal action levels.

Our current regulatory and individual brand processes establish an extensive testing framework that the current FDA guidance will help further inform. Baby food and baby formula brands are committed to the highest level of safety in their products and are among the most highly regulated foods in the U.S. The FDA’s Food Safety Modernization Act requires manufacturers to conduct a hazard analysis for heavy toxic metals for both their raw materials and finished product batches to ensure they meet or exceed FDA, WHO, and Codex standards. FDA is also working to develop new and improved testing methods to measure contaminants in food and is conducting surveys on foods commonly eaten by infants and young children to understand dietary exposure patterns better. We believe the ongoing work of the FDA on lead action levels will provide further transparency and education to consumers for these important products.

-- END --

SENATE COMMITTEE ON HEALTH

Senator Dr. Susan Talamantes Eggman, Chair

BILL NO: AB 899

SUBJECT: Food safety: infant formula and baby food

SUMMARY:

Requires in-state and out-of-state manufacturers of infant formula or baby food to test a representative sample of final product, as specified, and to disclose information to consumers about the name and levels of toxic heavy metals present in each final product, stating that the product meets federal guidance for that toxic heavy metal. Prohibits the sale, manufacture, or distribution of products in the state that do not comply with the requirements in this bill.

Existing law:

1. Defines, under federal law, “infant formula” as a food that purports to be or is represented for special dietary use solely as a food for infants by reason of its simulation of human milk or its suitability as a complete or partial substitute for human milk. [21 USC §321(z)]
2. Enacts the Sherman Food, Drug and Cosmetic Law (Sherman Law), enforced by the California Department of Public Health (CDPH), which provides broad authority for CDPH to enforce food safety requirements, including that food is not adulterated, misbranded, or falsely advertised. Food labeling requirements generally adopt federal food labeling laws as the state requirement, including nutrition labeling and allergen labeling, but CDPH is permitted, by regulation, to adopt additional food labeling regulations. [HSC §109875 et seq., §110380]
3. Requires CDPH to review all changes to the federal definition of infant formula before those changes are incorporated by reference to the Sherman Law, as specified. [HSC §109951]
4. Prohibits a retail food facility from selling or offering for sale after the “use by” date infant formula or baby food that is required to have this date on its packaging pursuant to federal law. [HSC §114094.5]
5. Defines the following under the Sherman Law:
6. “Label” as a display of written, printed, or graphic matter upon a food, drug, device, or cosmetic or upon its immediate container; and,
7. “Manufacture” as the preparation, compounding, propagation, processing, or fabrication of any food, drug, device, or cosmetic, including repackaging or otherwise changing the container, wrapper, or labeling of any food, drug, device, or cosmetic in furtherance of its distribution. Prohibits the term “manufacture” from including repackaging from a bulk container by a retailer at the time of sale to its ultimate consumer. [HSC §109955, 109970]

This bill:

1. Requires an in-state or out-of-state manufacturer of infant formula or baby food for sale or distribution in this state to do all of the following:
2. Beginning January 1, 2024, test a representative sample of each “production aggregate,” as defined, of their final infant formula or baby food product for toxic heavy metals, including levels of lead, mercury, cadmium, and arsenic. Permits a manufacturer to test final products before packaging individual units for sale or distribution;
3. Disclose product information, after January 1, 2025, for infant formula or baby food products sold, manufactured, delivered, held, or offered for sale in the state to consumers by making publicly available on its website the name and level of toxic heavy metals present in each production aggregate of their final infant formula or baby food product;
4. Disclose on a product label, after January 1, 2025, that the product is part of a production aggregate that has been tested for a toxic heavy metal that the U.S. Food and Drug Administration (FDA) has established an action level, regulatory limit, or tolerance for, regarding unavoidable contaminant in food for human consumption and food-packaging material; and,
5. Include on a product label, after January 1, 2025, that the product meets FDA guidance for that toxic heavy metal, if the production aggregate that the product is part of does not exceed an action level, regulatory limit, or tolerance established for a certain toxic heavy metal, pursuant to federal regulations regarding unavoidable contaminant in food for human consumption and food-packaging material.
6. Prohibits a person or entity to sell, manufacture, deliver, hold, or offer for sale in the state any baby food or infant formula that does not comply with the requirements in 1) above.
7. Defines “production aggregate” as a quantity of product, or, in the case of an infant formula produced by continuous process, a specific identified amount produced in a unit of time, that is intended to have uniform composition, character, and quality, and is produced according to a master manufacturing order.

FISCAL EFFECT:

According to the Assembly Appropriations Committee, CDPH estimates costs of approximately $731,000 in fiscal years (FYs) 2024-25, 2025-26, and 2026-27, and $582,000 in FY 2027-28 annually thereafter to ensure compliance with this bill (General Fund). The projected costs include three staff positions to determine which metals should be tested; implement the new requirements; work with industry and stakeholders on compliance and technical issues; generate educational material; answer questions, conduct inspections, and coordinate with the FDA on compliance issues; provide training for industry to resolve labeling issues; conduct compliance inspections; and provide information and answer questions to stakeholders and the public.

PRIOR VOTES:

COMMENTS:

1. Author’s statement. According to the author, this bill protects babies from harmful toxins. In September 2021, the U.S. House of Representatives Subcommittee on Economic and Consumer Policy released a report detailing concerning levels of heavy metals in baby food products. The report found products from multiple leading baby food producers in violation of FDA heavy metal limits, specifically in regards to arsenic levels in rice products. The Subcommittee recommended that manufacturers be required by the FDA to test final products for heavy metal levels, not just test their ingredients. The Subcommittee also recommended that manufacturers be required to report levels of heavy metals in their products. This bill builds upon on these recommendations and empowers parents by requiring baby formula and baby food manufacturers to test their finished products for heavy metal levels and to make publicly available on their website the name and level of toxic heavy metals present in the final product.
2. Congressional report and response. On November 6, 2019, following reports alleging high levels of toxic heavy metals in baby foods, the U.S. House of Representatives Committee on Oversight and Reform Subcommittee on Economic and Consumer Policy requested internal documents and test results from seven of the largest manufactures of baby food in the country: Nurture; Beech-Nut Nutrition Company; Hain Celestial Group, Inc.; Gerber; Campbell Soup Company; Walmart Inc.; and Sprout Foods, Inc. Four of the companies responded to the Subcommittee’s requests and produced internal testing policies and test results for ingredients/finished products and documentation about what the companies did with ingredients/finished products that exceeded their internal testing limits. However, Walmart, Campbell Soup, and Sprout Foods refused to cooperate with the Subcommittee’s investigation. On February 4, 2021, the Subcommittee released its report, “Baby Foods Are Tainted with Dangerous Levels of Arsenic, Lead, Cadmium, and Mercury,” which included the following:
3. Commercial baby foods are tainted with significant levels of toxic heavy metals, including arsenic, lead, cadmium, and mercury. Exposure to toxic heavy metals causes permanent decreases in IQ, diminished future economic productivity, and increased risk of future criminal and antisocial behavior in children. Toxic heavy metals endanger infant neurological development and long-term brain function;
4. Internal company standards permit dangerously high levels of toxic heavy metals, and documents revealed that the manufacturers often sold foods that exceeded the FDA levels; and,
5. The Subcommittee had grave concerns about baby food products produced by Walmart, Sprouts, and Campbell, which refused to cooperate with the Subcommittee, and that their lack of cooperation might obscure the presence of even higher levels of toxic heavy metals in their baby products compared to their competitors’ products.

Following the report, the federal FDA issued a response highlighting that toxic elements are present in the environment and may enter the food supply though soil, water, or air. Because these elements occur in the environment, they currently cannot be completely avoided in the fruits, vegetables, or grains that are the basis for baby foods, juices, and infant cereals. They also cannot be completely avoided by using organic farming practices. The FDA stated that while the report raised important questions, it has been actively working on this issue using a risk-based approach to prioritize and target their efforts. The FDA stated that consumers should know the FDA scientists routinely monitor levels of toxic elements in baby foods, along with other foods consumed in the country’s diet, through the Total Diet Study, and also monitors baby food under the FDA’s compliance program for Toxic Elements in Food and Foodware, Radionuclides in Food, and through targeted sampling assignments. One example is that since 2011, FDA sampling of infant rice cereal has shown that manufacturers have made significant progress in reducing arsenic in infant rice cereal products through selective sourcing and testing of rice and rice-derived ingredients (like rice flour).

1. Closer to Zero Initiative. In April 2021, the FDA announced the Closer to Zero initiative that identifies actions the FDA will take to reduce exposure to toxic elements in foods eaten by babies and young children to the lowest levels possible. The FDA has prioritized babies and young children because their smaller body sizes and metabolism make them more vulnerable to the harmful effects of these contaminants. To meet the goals of Closer to Zero, the FDA will focus on:
2. Research and analysis to include developing new and improved testing methods to measure lower levels of contaminants in food; identifying reference levels for these contaminants to determine levels of concern; conducting surveys on foods commonly eaten by infants and young children to understand variability in concentrations of arsenic, lead, cadmium, and mercury in these foods; and, understanding how nutrients can help protect against the health effects associated with contaminants;
3. Regulation to include establishing action levels, and increasing targeted compliance and enforcement activities; and,
4. Consultation to encourage adoption of agricultural and processing best practices by industry to lower levels of environmental contaminants in agricultural commodities and products.

The FDA points out that reducing levels of contaminants in foods is complicated and multifaceted. It is crucial to ensure that measures taken to limit arsenic, lead, cadmium, and mercury in foods do not have unintended consequences—like eliminating from the marketplace foods that have significant nutritional benefits or reducing the presence of one element while increasing another.

1. FDA’s national strategy. In March 2023, the FDA released “The U.S. FDA’s Immediate National Strategy to Increase the Resiliency of the U.S. Infant Formula Market,” where they highlighted several events that led to the shortage of infant formula in 2022, beginning with information they received between September 2021 and January 2022 about four cases of illness or death in infants who consumed powdered infant formula. A series of Abbott Nutrition facility closures and voluntary recall of certain products contributed to the shortage, which was further compounded by a struggling recovery of the supply chain due to the COVID-19 pandemic and long-standing circumstances that shaped the production of infant formula in the U.S. over the years (infant formula supply is highly concentrated in a small number of manufacturers, which means a small problem can significantly affect overall supply. In 2022, four companies controlled 99% of the infant formula market). The FDA further states that they lacked authority, resources, and staff dedicated to predicting, detecting, and responding to supply chain issues for infant formula, even though they had been requesting authority since 2020. In 2022, the FDA conducted 34 inspections of foreign and domestic facilities that produce infant formula, meeting FDA’s inspection targets for 2022. In November 2022, the FDA released a draft outline of a strategy to prevent Cronobacter sakazakii illnesses associated with the consumption of powdered infant formula. And in March 2023, as part of the prevention strategy work, the FDA sent a letter to the powdered infant formula industry to share current safety information and call on the industry to take prompt action to improve processes and programs. Other actions the FDA has taken include:
2. Significantly expanding and improving a required infant formula online training course for investigators and other appropriate staff to ensure robust inspection;
3. Requiring staff who conduct or support inspections of powdered formula manufacturers to attend an interactive in-person inspection workshop with specific training on conducting infant formula inspections;
4. Creating a new Office of Critical Foods responsible for oversight, coordination, and activities related to critical foods, which is defined as infant formula and medical foods;
5. Expediting review of premarket infant formula submissions if an infant formula shortage has been identified;
6. Working with relevant federal agencies to work together to develop a National Strategy on Infant Formula to address supply chain resiliency; and,
7. Seeking additional authority to require that, among other things, manufacturers report to the FDA final product positive test results for relevant pathogens; conduct more frequent environmental monitoring in their facilities to identify relevant pathogens; and maintain the results of such testing for FDA inspection, either in person or remotely.
8. Double referral. This bill is double referred. Should it pass out of this Committee, it will be referred to the Senate Environmental Quality Committee.
9. Related legislation. AB 228 (Wilson, Bains, Weber) requires CDPH and the Office of Emergency Services, by January 1, 2025, in coordination with other state agencies as appropriate, to establish an infant formula stockpile, upon appropriation and as necessary. AB 228 was held on the Assembly Appropriations Committee suspense file.
10. Prior legislation. AB 1316 (Quirk, Chapter 507, Statutes of 2017) requires CDPH to revise its regulations for the Childhood Lead Poisoning Prevention Program to redefine the assessment of risks for the purposes of evaluating a child's risk for lead exposure.

AB 688 (Pan, Chapter 681, Statutes of 2011), among other things, prohibits a retail food facility from selling or offering for sale after the “use by” date infant formula or baby food that is required to have this date on its packaging pursuant to federal law.

AB 455 (Chu, Chapter 679, Statutes of 2003) enacted the “Toxics in Packaging Prevention Act,” which prohibits a manufacturer, importer, agent, or supplier, as defined, from offering for sale or for promotional purposes in this state a package or packaging component that includes a regulated metal, defined as lead, cadmium, mercury, or hexavalent chromium, if that regulated metal has been intentionally introduced into the package or packaging component during manufacturing or distribution.

1. Support. Supporters of this bill cite the Congressional report and state that investigators found some companies were not testing their finished food products at all. Instead, manufacturers were testing heavy metal levels in ingredients and using those levels to estimate levels in finished products. This method was determined to understate the toxic heavy metal levels in finished products. Supporters further state that, in June 2021, public health officials in the State of Alaska found that multiple samples of Beech-Nut and Gerber’s infant rice cereals exceeded the FDA’s 100 ppb limits for inorganic arsenic in infant rice cereal. Beech-Nut had tested the rice flour used to make the rice cereal and found arsenic levels below the FDA guidance levels, highlighting the ineffectiveness of ingredient-only testing. Supporters argue researchers find repeatedly that heavy metals are detrimental to cognitive development. Exposure to heavy metals at an early age has been linked to lower IQs, behavior problems, cardiovascular issues, and attention deficit hyperactivity disorder. In 2017, researchers at Duke University studied 565 adults who had their lead levels measured as children. Those with high childhood lead readings had IQ levels 4.25 points lower on average. Supporters state that this bill acts on recommendations made by the Subcommittee on Economic and Consumer Policy and empowers parents by requiring manufacturers to test for and publicize levels of toxic heavy metals in their baby food and infant formula products.
2. Opposition. The Consumer Brands Association states they are opposed to this bill as it is currently drafted because they believe it is premature given the ongoing, active FDA guidance development process to determine action levels for lead in food. They state their current regulatory and individual brand processes establish an extensive testing framework that the current FDA guidance will help further inform. They also state that the labeling requirements in this bill would create significant consumer confusion and difficult compliance issues for manufacturers.
3. Oppose unless amended. The Infant Nutrition Council of America (INCA) states that infant formula is the most highly regulated food in the U.S. food supply, and INCA members take the commitment to deliver safe formulas to the most vulnerable population very seriously. INCA argues their industry meets or exceeds infant formula standards established by the FDA, European Food Safety Authority, Joint FAO/World Health Organization Expert Committee on Food Additives, and Codex Alimentarius as part of their longstanding commitment to provide safe, high-quality infant formula products. If any product is out of compliance with these standards and requirements, it is not released to the public. All lab results and retained product samples are maintained and inspected by regulatory authorities in every market where they operate. INCA states that the FDA requires that manufacturers conduct a hazard analysis and establish risk-based preventive controls (including raw material hazards, such as potential for heavy toxic metal contamination). INCA members are working with the FDA to establish action levels for toxic heavy metals in infant formula, which will bring improved transparency to the public on the measures already in place across the infant formula industry. INCA argues that this bill proposes requirements prior to allowing FDA experts to establish appropriate action levels and could create confusion related to safe, nutritious infant formulas currently on the market, which could result in parents switching to inappropriate and less safe options, such as homemade infant formula. INCA requests an amendment to eliminate infant formula from the bill until the FDA establishes maximum residue limits for toxic heavy metals.

SUPPORT AND OPPOSITION:

Support: American Academy of Pediatrics, California

California Chapters of the National Association of Pediatric Nurse Practitioners
Center for Food Safety
CleanEarth4Kids.org

Consumer Attorneys of California
Educate. Advocate.

Environmental Working Group

Junior Leagues of California State Public Affairs Committee

Oppose: Consumer Brands Association

Infant Nutrition Council of America (unless amended)

-- END --

ASSEMBLY THIRD READING

ATR Bill Id:AB 899

Author:(Muratsuchi)

As Amended Ver:April 12, 2023

Majority vote

SUMMARY

Requires, beginning January 1, 2024, an in-state or out-of-state manufacturers (manufacturers) of infant formula or baby food sold or distributed in this state to test a representative sample of each production aggregate of their final infant formula or baby food product for toxic heavy metals, including levels of lead, mercury, cadmium, and arsenic. Permits a manufacturer to test their final infant formula or baby food product before packaging individual units of infant formula or baby food for sale or distribution.

Requires, for infant formula or baby food products sold, manufactured, delivered, held, or offered for sale in the state or and after January 1, 2025, disclose product information to consumers by doing all of the following: 1) make publicly available on its internet website the name and level of toxic heavy metals present in each production aggregate of their final infant formula or baby food product; and, 2) disclose on a product label that the product is a part of a production aggregate that has been tested for a toxic heavy metal that the federal Food and Drug Administration (FDA) has established an action level, regulatory limit, or tolerance, as specified.

Major Provisions

COMMENTS

Regulation of infant formula. The FDA requires infant formula manufacturers to comply with the Federal Food, Drug and Cosmetic Act (FDCA). FDCA includes certain requirements relating to nutrient content, nutrient quantity, nutrient quality control, recordkeeping, reporting, and recall of infant formulas. In addition, the FDCA requires persons responsible for the manufacture or distribution of infant formula to register with FDA and to make a submission to the FDA for any new infant formula, which includes any infant formula that has had a major change in its formulation or processing, 90 days before any charitable or commercial distribution. After the first processing of a new infant formula, but before marketing, persons responsible for the manufacture or distribution of infant formula must submit to the FDA a written verification which demonstrates that the formula, as actually produced, complies with the FDCA's requirements. A summary of test results of nutrients in the formula is required. Under the authority of the FDCA, the FDA has promulgated regulations that specify infant formula nutrient quality control procedures; records and reports; and submission requirements; the labeling of infant formula; the terms and conditions under which certain infant formula may be exempt from some of the FDCA’s requirements; nutrient specifications for infant formula; and infant formula recalls. In 2014, the agency revised its infant formula regulations to establish quality factors, current good manufacturing practices, and revised quality control procedures. In the United States, baby food is treated similarly to adult foods.

Heavy Metals in Baby Food. On November 6, 2019, following reports alleging high levels of toxic heavy metals in baby foods, the Subcommittee on Economic and Consumer Policy Committee on Oversight and Reform at the United States (U.S.) House of Representatives (Subcommittee) requested internal documents and test results from seven of the largest manufactures of baby food in the United States:

1. Nurture, Inc. which sells Happy Family Organics, including baby food products under the brand name HappyBABY;
2. Beech-Nut Nutrition Company;
3. Hain Celestial Group, Inc. which sells baby food products under the brand name Earth’s Best Organic;
4. Gerber;
5. Campbell Soup Company, which sells baby food under the name Plum Organics;
6. Walmart Inc.; and,
7. Sprout Foods, Inc. (Sprout Organics Foods).

Four of the companies responded to the subcommittee’s requests and produced internal testing policies and test results for ingredients/finished products and documentation about what the companies did with ingredients/finished products that exceeded their internal testing limits. However, Walmart, Campbell, and Sprout Organics Foods refused to cooperate with the subcommittee’s investigation.

On February 4, 2021, the Subcommittee released its report (report) which includes the following findings.

1. Commercial baby foods are tainted with significant levels of toxic heavy metals, including arsenic, lead, cadmium, and mercury. Exposure to toxic heavy metals causes permanent decreases in IQ, diminished future economic productivity, and increased risk of future criminal and antisocial behavior in children. Toxic heavy metals endanger infant neurological development and long-term brain function;
2. Internal company standards permit dangerously high levels of toxic heavy metals, and documents revealed that the manufacturers often sold foods that exceeded FDA levels; and,
3. The Subcommittee has grave concerns about baby food products produced by Walmart, Sprouts, and Campbell which refused to cooperate with the Subcommittee, and that their lack of cooperation might obscure the presence of even higher levels of toxic heavy metals in their baby products, compared to their competitors’ products.

The Subcommittee also pointed out that corporate policies to test only ingredients, not final products underrepresent the levels of toxic heavy metals in baby foods; naturally occurring toxic heavy metals may not be the only problem causing the unsafe levels of toxic heavy metals in baby foods; rather baby food producers may be adding ingredients that have high levels of toxic heavy metals into their products, such as vitamin/mineral pre-mix; and that only final product testing can measure the true danger posed by baby foods.

According to the Author

This bill protects babies from harmful toxins. In September 2021, the United States House of Representatives Subcommittee on Economic and Consumer Policy released a report detailing concerning levels of heavy metals in baby food products. The report found products from multiple leading baby food producers in violation of FDA heavy metal limits, specifically in regards to arsenic levels in rice products. The Subcommittee recommended that manufacturers be required by the FDA to test final products for heavy metal levels, not just test their ingredients. The Subcommittee also recommended that manufacturers be required to report levels of heavy metals in their products. The author concludes this bill acts on these recommendations and empowers parents by requiring baby formula and baby food manufacturers to test their finished products for heavy metal levels and to make publicly available on their website the name and level of toxic heavy metals present in the final product.

Arguments in Support

The American Academy of Pediatrics, the Center for Food Safety, and the Consumer Attorneys of California write in support that researchers find repeatedly that heavy metals are detrimental to cognitive development. Exposure to heavy metals at an early age has been linked to lower IQs, behavior problems, cardiovascular issues, and attention deficit hyperactivity disorder. This bill acts on recommendations made by the Subcommittee and empowers parents by requiring manufacturers to test for and publicize levels of toxic heavy metals in their baby food and infant formula products.

Arguments in Opposition

The Infant Nutrition Council of America, an association of U.S. manufacturers of infant formulas and toddler milks, has an oppose unless amended position on this bill and requests amendments to be exempt from the provisions of this bill..

FISCAL COMMENTS

According to the Assembly Appropriations Committee:

The California Department of Public Health estimates costs of approximately $731,000 in fiscal years (FYs) 2024-25, 2025-26, and 2026-27, and $582,000 in FY 2027-28 annually thereafter to ensure compliance with AB 899 (General Fund). The projected costs include three staff positions to determine which metals should be tested; implement the new requirements; work with industry and stakeholders on compliance and technical issues; generate educational material; answer questions, conduct inspections, and coordinate with the FDA on compliance issues; provide training for industry to resolve labeling issues; conduct compliance inspections; and provide information and answer questions to stakeholders and the public.

VOTES

ASM HEALTH: 11-1-3

YES: Wood, Waldron, Aguiar-Curry, Arambula, Boerner Horvath, Maienschein, McCarty, Rodriguez, Santiago, Villapudua, Weber

NO: Joe Patterson

ABS, ABST OR NV: Wendy Carrillo, Flora, Vince Fong

ASM ENVIRONMENTAL SAFETY AND TOXIC MATERIALS: 8-0-1

YES: Lee, Arambula, Bauer-Kahan, Connolly, McKinnor, Pacheco, Ta, Zbur

ABS, ABST OR NV: Hoover

ASM APPROPRIATIONS: 14-0-2

YES: Holden, Megan Dahle, Bryan, Calderon, Wendy Carrillo, Mike Fong, Hart, Lowenthal, Mathis, Papan, Pellerin, Sanchez, Weber, Ortega

ABS, ABST OR NV: Dixon, Robert Rivas

UPDATED

VERSION: April 12, 2023

CONSULTANT: Rosielyn Pulmano / HEALTH / (916) 319-2097 FN: 0000738

Date of Hearing: May 10, 2023

ASSEMBLY COMMITTEE ON APPROPRIATIONS

Chris Holden, Chair

ABPCA Bill Id:AB 899

Author:(Muratsuchi) – As Amended Ver:April 12, 2023

Urgency: No State Mandated Local Program: Yes Reimbursable: No

SUMMARY:

This bill requires a manufacturer of infant formula and baby food for sale or distribution in California to test their final product for heavy metals and provide the test results on the manufacturer’s website.

FISCAL EFFECT:

The California Department of Public Health (CDPH) estimates costs of approximately $731,000 in fiscal years (FYs) 2024-25, 2025-26, and 2026-27, and $582,000 in FY 2027-28 annually thereafter to ensure compliance with AB 899 (General Fund). The projected costs include three staff positions to determine which metals should be tested; implement the new requirements; work with industry and stakeholders on compliance and technical issues; generate educational material; answer questions, conduct inspections, and coordinate with the federal Food and Drug Administration (FDA) on compliance issues; provide training for industry to resolve labeling issues; conduct compliance inspections; and provide information and answer questions to stakeholders and the public.

COMMENTS:

1. Purpose. According to the author:

AB 899 protects babies from harmful toxins. In September 2021, the US House of Representatives Subcommittee on Economic and Consumer Policy released a report detailing concerning levels of heavy metals in baby food products. The report found products from multiple leading baby food producers in violation of FDA heavy metal limits, specifically in regards to arsenic levels in rice products.

The Subcommittee recommended that manufacturers be required by the FDA to test final products for heavy metal levels, not just test their ingredients. The Subcommittee also recommended that manufacturers be required to report levels of heavy metals in their products.

AB 899 acts on these recommendations and empowers parents by requiring baby formula and baby food manufacturers to test their finished products for heavy metal levels and to make publicly available on their website the name and level of toxic heavy metals present in the final product.

1. Equity Concerns. Infant formula can be an essential food for many babies. Higher rates of infant formula use among certain socioeconomic, racial, and ethnic groups means babies from these communities are more likely to be exposed if heavy metals are present in their formula or baby food. In 2022, the Kaiser Family Foundation released an analysis of formula use using nationwide data from the U.S. Centers for Disease Control and Prevention (CDC). The analysis showed:

• 54% of infants born in 2018 received formula, either exclusively or as a supplement, by three months of life.
• Infants in low-income families, infants of color, and infants living in rural communities are more likely to use formula. Infants in lower income households are less likely than those in higher income households to report exclusive breastfeeding through the first three months of life. Lower proportions of Black and Hispanic infants are exclusively breastfed through their first three months of life compared to white infants. Infants living in rural areas are also less likely to have ever been breastfed than those in urban areas.
• Almost half of all formula in the U.S. is purchased by families enrolled in the Women, Infants, and Children program (WIC), a nationwide program designed to support low-income women, infants, and children up to age five years who are at nutritional risk.

1. Related Legislation.
   1. AB 228 (Wilson) requires CDPH and the Office of Emergency Services, in coordination with other state agencies, to establish an infant formula stockpile. AB 228 is pending in this committee.
   2. AB 418 (Gabriel) prohibits a person or entity from manufacturing, selling, delivering, distributing, holding, or offering for sale a food product that contains brominated vegetable oil, potassium bromate, propylparaben, red dye 3, or titanium dioxide. AB 418 is pending on the Assembly Floor.

Analysis Prepared by: Allegra Kim / APPR. / (916) 319-2081

Date of Hearing: April 18, 2023

ASSEMBLY COMMITTEE ON ENVIRONMENTAL SAFETY AND TOXIC MATERIALS

Alex Lee, Chair

ABPCA Bill Id:AB 899 (

Author:Muratsuchi) – As Amended Ver:April 12, 2023

SUBJECT: Food safety: infant formula and baby food

SUMMARY: Requires an in-state or out-of-state manufacturer of infant formula or baby food for sale or distribution in California to test their final infant formula or baby food product for toxic heavy metals, including lead, mercury, cadmium, and arsenic; post on the manufacturer's website the name and level of toxic heavy metals present in their product; and disclose on a product label that the product has been tested for a toxic heavy metal for which there is an action level, regulatory limit, or tolerance level established by the federal Food and Drug Administration (FDA). Specifically, this bill:

1. Establishes the following definitions, for the purposes of the bill:
2. "Baby food" means food packaged in jars, pouches, tubs, and boxes represented or purported to be specifically for babies and young children less than two years old.
3. "Final infant formula or baby food product" means the finished product of infant formula or baby food and not the constituent ingredients of infant formula or baby food.
4. "Infant formula" means a food that purports to be or is represented for special dietary use solely as a food for infants by reason of its simulation of human milk or its suitability as a complete or partial substitute for human milk.
5. "Product label" means a display of written, printed, or graphic material that is affixed to a product or its immediate container.
6. "Production aggregate" means a quantity of product, or, in the case of an infant formula produced by continuous process, a specific identified amount produced in a unit of time, that is intended to have uniform composition, character, and quality, and is produced according to a master manufacturing order.  
7. "Representative sample" means a sample that consists of a number of units that are drawn based on rational criteria, such as random sampling, and intended to ensure that the sample accurately portrays the material being sampled.
8. Requires an in-state or out-of-state manufacturer of infant formula or baby food for sale or distribution in California to do all of the following:
9. Test, beginning on January 1, 2024, a representative sample of each production aggregate of their final infant formula or baby food product for toxic heavy metals, including levels of lead, mercury, cadmium, and arsenic. Manufacturers are authorized to test their final infant formula or baby food product before individual units are packaged for sale or distribution;
10. Disclose, on and after January 1, 2025, product information to consumers for infant formula or baby food products sold, manufactured, delivered, held, or offered for sale in the state by doing all of the following:
11. Make publicly available on the manufacturer's website the name and level of toxic heavy metals present in each production aggregate of their final infant formula or baby food product.
12. Disclose on a product label that the product is a part of a production aggregate that has been tested for a toxic heavy metal that the FDA has established an action level, regulatory limit, or tolerance for.
13. Include a product label showing that the product meets FDA guidance for a toxic metal, if the production aggregate that the product is a part of does not exceed an action level, regulatory limit, or tolerance established by the FDA for that heavy metal.
14. Prohibit a person or entity from selling, manufacturing, delivering, holding, or offering for sale in the state any baby food or infant formula that does not comply with the requirements of the bill.

EXISTING LAW:

1. Defines, for the purposes of federal infant formula requirements under the federal Food, Drug, and Cosmetic Act (FD&C Act), "infant formula" to mean a food which purports to be or is represented for special dietary use solely as a food for infants by reason of its simulation of human milk or its suitability as a complete or partial substitute for human milk. (21 Code of Federal Regulations (CFR) § 106.3)
2. Defines "production aggregate" to mean a quantity of product, or, in the case of an infant formula produced by continuous process, a specific identified amount produced in a unit of time, that is intended to have uniform composition, character, and quality, within specified limits, and is produced according to a master manufacturing order. (21 CFR § 106.3)
3. Defines "representative sample" to mean a sample that consists of a number of units that are drawn based on rational criteria, such as random sampling, and intended to ensure that the sample accurately portrays the material being sampled. (21 CFR § 106.3)
4. Specifies minimum good manufacturing practices that are to be used in, and the facilities or controls that are to be used for, the manufacture, processing, packing, or holding of an infant formula; specifies that failure to comply with federal regulations for the manufacture, processing, packing, or holding of infant formula shall render the formula adulterated. (21 CFR § 106.5 et seq.)
5. Specifies nutrient testing requirements for infant formula, including that manufacturers test a representative sample of each production aggregate of finished products for nutrient levels. (21 CFR § 106.91 et seq.)
6. Requires a manufacturer to establish controls to ensure that federally-mandated nutrient levels are maintained in the formula, and that the formula is not contaminated with microorganisms or other contaminants. (21 CFR § 106.5)
7. Prohibits, under the federal FD&C Act, the introduction or delivery for introduction into interstate commerce of any food that is adulterated or misbranded. (21 United States Code § 331(a))
8. Authorizes the establishment of a tolerance, regulatory limit, or action level for an added poisonous or deleterious substance in food, as follows (21 CFR § 109.4):
   1. A tolerance may be established by regulation to prohibit any detectable amount of the substance in food.
   2. A regulatory limit may be established by regulation to prohibit any detectable amount of the substance in food. The regulatory limit established represents the level at which food is adulterated.
   3. An action level may be established to define a level of contamination at which a food may be regarded as adulterated. Whenever an action level is established or changed, a notice shall be published in the Federal Register, call attention to the material supporting the action level, and invite public comment on the action level.
9. Specifies that a regulatory limit may be established if there is no tolerance for an added poisonous or deleterious substance in a particular food; specifies that an action level will be withdrawn when a tolerance or regulatory limit for the same substance and use has been established. (21 CFR § 109.6)
10. Establishes the state Sherman Food, Drug, and Cosmetics Law (Sherman Law), administered by the California Department of Public Health (CDPH), which regulates the manufacture, packaging, labeling, and advertising of food, drugs, and cosmetics. (Health and Safety Code (HSC) § 109875-111929.4)
11. Defines the following under the Sherman Law:
    1. A label to mean a display of written, printed, or graphic matter upon a food, drug, device, or cosmetic or upon its immediate container. (HSC § 109955)
    2. Manufacture to mean the preparation, compounding, propagation, processing, or fabrication of any food, drug, device, or cosmetic. The term "manufacture" includes repackaging or otherwise changing the container, wrapper, or labeling of any food, drug, device, or cosmetic in furtherance of the distribution of the food, drug, device, or cosmetic. The term "manufacture" does not include repackaging from a bulk container by a retailer at the time of sale to its ultimate consumer. (HSC § 109970)
12. Requires all labels of foods, drugs, devices, or cosmetics to conform to federal requirements, as specified. (HSC § 110340)
13. Prohibits, under the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65), a person in the course of doing business from knowingly and intentionally exposing any individual to a chemical known to the state to cause cancer or reproductive toxicity without first giving clear and reasonable warning to such individual. (HSC § 25249.6)
14. Provides that any person who violates the above provision under Proposition 65 may be enjoined in any court of competent jurisdiction and shall be liable for a civil penalty not to exceed $2,500 per day for each violation in addition to any other penalty established by law. (HSC § 25249.7)
15. Authorizes, under Proposition 65, a warning to be provided by general methods, such as labels on consumer products, posting of notices, placing notices in public news media, and the like, provided that the warning is clear and reasonable; provides that regulations implementing Proposition 65 shall, to the extent practicable, place the obligation to provide any warning materials on the producer or packager rather than on the retail seller, except where the retail seller itself is responsible for introducing a chemical known to the state to cause cancer or reproductive toxicity. (HSC § 25249.11(f))

FISCAL EFFECT: Unknown.

COMMENTS:

Need for the bill: According to the author:

"AB 899 protects babies from harmful toxins. In September 2021, the US House of Representatives Subcommittee on Economic and Consumer Policy released a report detailing concerning levels of heavy metals in baby food products. The report found products from multiple leading baby food producers in violation of FDA heavy metal limits, specifically in regards to arsenic levels in rice products.

The Subcommittee recommended that manufacturers be required by the FDA to test final products for heavy metal levels, not just test their ingredients. The Subcommittee also recommended that manufacturers be required to report levels of heavy metals in their products.

AB 899 acts on these recommendations and empowers parents by requiring baby formula and baby food manufacturers to test their finished products for heavy metal levels and to make publicly available on their website the name and level of toxic heavy metals present in the final product."

Consequences of heavy metal exposure in children: This bill specifically requires manufacturers to test for arsenic, cadmium, lead, and mercury. Below are descriptions of these heavy metals and their health implications for children.

• Arsenic: According to the federal Agency for Toxic Substances and Disease Registry (ATSDR), children are exposed to arsenic in many of the same ways that adults are, although children may be at higher risk of exposure because of normal hand-to-mouth activity. Since arsenic is found in soil, water, food, and air, children may take in arsenic in the air they breathe, the water they drink, and the food they eat. In addition, since children tend to eat or drink less of a variety of foods and beverages than adults do, ingestion of contaminated food, juice, or infant formula made with arsenic-contaminated water may represent a significant source of exposure.

Some of the effects of arsenic exposure in children may be similar to those noted in adults, including irritation of the stomach and intestines, blood vessel damage, skin changes, and reduced nerve function. There is also some evidence that long-term exposure to inorganic arsenic in children may result in lower IQ scores, and that exposure in early life (including gestation and early childhood) may increase mortality later in life, in young adulthood.

• Cadmium: According to the ATSDR, in the United States, the primary source of cadmium exposure for nonsmokers is from the food supply. In general, potatoes, grains, peanuts, soybeans, sunflower seeds, and leafy vegetables such as lettuce and spinach contain high levels of cadmium. Because cadmium binds strongly to organic matter, it can enter the food supply by accumulating in aquatic organisms and agricultural crops.

According to a literature review by Flannery et al. (2022) in Regulatory Toxicology and Pharmacology, 90% of cadmium exposure is dietary in those who are not exposed through smoking or occupation. In adults, cadmium is known to accumulate in organs over time, leading to kidney dysfunction and decreased bone density, among other adverse effects. More studies are needed to better understand the adverse effects of cadmium exposure in infants and children, although the ATSDR states that the health effects seen in children from exposure to toxic levels of cadmium are expected to be similar to the effects seen in adults (kidney and lung damage). A few studies in animals suggest that younger animals absorb more cadmium than adults, and that young animals are more susceptible than adults to bone loss and decreased bone strength resulting from cadmium exposure.

• Lead: According to the Centers for Disease Control and Prevention (CDC), research shows that there is no safe level of lead and even very low levels can have negative and irreversible health effects, especially in children. Childhood lead exposure can seriously harm a child's health and cause well-documented adverse effects, including brain and nervous system damage, slowed growth and development, learning and behavior problems, and hearing and speech problems. These health impacts can in turn lead to decreased attention and underperformance in school among lead-exposed children. One study by Evens et al. (2015), published in Environmental Health, examined data for nearly 58,000 children attending Chicago public schools and found that increasing blood lead levels were associated with increasing failure rates on standardized reading and math tests. The authors found that this effect persisted, even when they controlled for other predictors of school performance, including poverty, race, ethnicity, gender, maternal education, birth weight, and prematurity. Among children with the lowest blood lead levels, even small increases in blood lead levels were associated with what the authors described as "steeper failure rates."
• Mercury: According to the ATSDR, food is the most common route of exposure to mercury. Most people are exposed to organic mercury compounds (typically methylmercury) in foods such as fish, seafood, and rice. The health effects of mercury exposure depend on a number of factors, including the amount and form of mercury, route and length of exposure, and age. All forms of mercury can affect the nervous system and the kidneys. People who eat foods with high levels of methylmercury may experience tremors, coordination problems, impaired vision, impaired learning and memory, and mood changes. Some children born in communities that ate food with high levels of organic mercury had learning, sensory, and movement problems. In people exposed to high levels of methylmercury in their diets, birth defects have occurred. In addition, research shows that some humans and animals that ate mercury compounds had high blood pressure and alterations in their immune systems, and animals that ate high levels of mercury compounds showed decreased fertility and/or birth defects.

Equity concerns relating to formula: Infant formula can be an essential and life-giving food for many babies. However, the potential presence of heavy metals raises both short- and long-term health concerns. Higher rates of infant formula use among certain socioeconomic, racial, and ethnic groups can mean that babies from these communities are more likely to be exposed, if heavy metals are present in their formula. In 2022, the Kaiser Family Foundation released an analysis of formula use using nationwide data from the CDC. The analysis showed that:

• More than half (54%) of infants born in 2018 received formula, either exclusively or as a supplement, by three months of life.
• Infants in low-income families, infants of color, and infants living in rural communities are more likely to use formula.  Infants in lower income households are less likely than those in higher income households to report exclusive breastfeeding through the first three months of life. Similarly, data show that lower shares of Black and Hispanic infants are exclusively breastfed through their first three months of life compared to White infants. CDC data also show Black infants born in 2018 are less likely to have ever been breastfed compared to Asian, White, and Hispanic infants. Infants living in rural areas are also less likely to have ever been breastfed than those in urban areas.
• The majority of children under the age of one covered by Medicaid and the Children's Health Insurance Plan (CHIP) are infants in low-income families and infants of color. Over one-third (34%) of all children who reported receiving formula during the first 12 months of their life were covered by Medicaid/CHIP only.
• Almost half of all formula in the United States is purchased by families enrolled in the Women, Infants, and Children program (WIC).  WIC is a nationwide program designed to support low-income women, infants, and children up to age five found to be at nutritional risk.

Regulation of heavy metals in baby food and infant formula: Both federal and state laws regulate contaminants in consumer products; these laws have, to varying degrees, been used to regulate contaminants specifically in baby food and infant formula. Two major bodies of law—the federal FD&C and Proposition 65—and their use in regulating heavy metals in baby food and infant formula are described further below.

• The FDA and the federal Food, Drug, and Cosmetics Act (FD&C): Under the FD&C, the FDA is authorized to establish tolerances, regulatory limits, or action levels for contaminants in food. Exceedance of established regulatory limits or action levels can be used to deem a food "adulterated," which gives the FDA the authority to initiate enforcement actions that can range from issuing a letter notifying the individual or firm of a violation and requesting correction, to criminal prosecution of the individual or firm. The FDA maintains that while action levels are a useful tool for driving down contaminant levels in foods, the agency does not need an action level for a contaminant to take enforcement action. By law, food manufacturers and processors have a responsibility to implement preventive controls as needed to minimize or prevent exposure to chemical hazards—including lead, arsenic, cadmium, and mercury. However, in light of results from a Congressional investigation of heavy metals in baby food (described below), it is unclear to what extent the FDA is using its authority to hold manufacturers accountable for heavy metals in their products.

As of 2023, the FDA has used its authority under the FD&C to establish contaminant standards for only a handful of foods, only one of which is a type of baby food. These standards are:

• • Action Levels: apple juice (10 parts per billion (ppb) lead, 10 ppb inorganic arsenic), chocolate and hard candy (100 ppb lead), and infant rice cereal (100 ppb inorganic arsenic); and,
  • Bottled water standards: 5 ppb lead, 10 ppb arsenic, 5 ppb cadmium, 2 ppb mercury.

In April 2021, the FDA announced the Closer to Zero initiative, which identifies actions the FDA will take to reduce exposure to lead, arsenic, cadmium, and mercury in foods eaten by babies and young children to the lowest levels possible. The FDA has prioritized babies and young children because their smaller body sizes and metabolism make them more vulnerable to the harmful effects of contaminants. To meet the goals of Closer to Zero, the FDA will focus on:

• Research and analysis, to include developing new and improved testing methods to measure lower levels of contaminants in food;
• Regulation, to include establishing action levels, increasing targeted compliance and enforcement activities, and monitoring levels over time to determine possible adjustments to action levels. Through a process that may include engagement with stakeholders, advisory committees, public workshops, and consultation with scientific experts, federal agency partners and other stakeholders, the FDA will establish interim reference levels (IRLs) as appropriate. An IRL is a "measure of exposure to a contaminant from food that the FDA may use to determine if the amount of exposure to the contaminant, across foods, could result in a specific health impact." The FDA may use IRLs to inform the development of action levels; and,
• Consultation, to include encouraging adoption of agricultural and processing best practices by industry to lower levels of environmental contaminants in agricultural commodities and products.

In 2023, the FDA released its first set of draft guidance under the Closer to Zero initiative. The draft guidance lists potential action levels for lead in baby foods. Action levels are as follows:

• 10 ppb for fruits, vegetables (excluding single-ingredient root vegetables), mixtures (including grain and meat-based mixtures), yogurts, custards/puddings, and single-ingredient meats;
• 20 ppb for root vegetables (single ingredient); and,
• 20 ppb for dry infant cereals.

In 2018, the FDA developed an IRL for dietary lead to serve as an interim standard while action levels undergo review, and to replace the FDA's prior provisional tolerable total daily intake (PTTDI), which had been developed in the early 1990s. The IRL, updated in 2022, is set at 2.2 micrograms (μg) of lead/day for children. For comparison, the PTTDI had been set at 6 μg of lead/day. Draft action levels and guidance for arsenic and cadmium are expected to be developed some time in 2024; the FDA has not yet specified a date for the development of draft guidance or action levels for mercury.

Importantly, the FDA notes that "FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe FDA’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in FDA guidances means that something is suggested or recommended, but not required." This raises a question about the extent to which industry will abide by FDA's guidance, in the absence of FDA enforcement actions and/or mandates for compliance and transparency established at the state level.

For infant formula, the FDA has established manufacturer requirements relating to nutrient content, nutrient quantity, nutrient quality control, recordkeeping, reporting, and product recalls under the FD&C Act. In addition, the FD&C Act requires persons responsible for the manufacture or distribution of infant formula to register with the FDA and to make a submission to the FDA for any new infant formula, which includes any infant formula that has had a major change in its formulation or processing. After the first processing of a new infant formula, but before marketing, persons responsible for the manufacture or distribution of infant formula must submit to the FDA a written verification demonstrating that the formula complies with the FD&C Act's requirements.

Under the authority of the FD&C Act, the FDA has also promulgated regulations that specify rules on infant formula nutrient quality control procedures, records and reports, submission requirements, labeling, the terms and conditions under which certain infant formula may be exempt from some of the FD&C Act’s requirements, nutrient specifications, and infant formula recalls.

In 2014, the agency revised its infant formula regulations to establish quality factors, current good manufacturing practices, and revised quality control procedures. Manufacturers are required to establish controls that ensure mandated nutrient levels are maintained, and that the formula is not contaminated with microorganisms or other contaminants. Notably, FDA regulations on good manufacturing practices only explicitly mention "heavy metals" in a provision stating that manufacturers "shall not reprocess or otherwise recondition an ingredient, container, or closure rejected because it is contaminated with microorganisms of public health significance or other contaminants, such as heavy metals." (21 CFR § 106.4(e)(3))

California's Proposition 65: In 1986, California voters approved a ballot initiative, the Safe Drinking Water and Toxic Enforcement Act of 1986, commonly referred to as Proposition 65, to address concerns that "hazardous chemicals pose a serious potential threat to their health and well-being, [and] that state government agencies have failed to provide them with adequate protection…" Proposition 65 requires the state to publish a list of chemicals known to cause cancer or birth defects or other reproductive harm. This list, which must be updated at least once a year, currently includes approximately 900 chemicals. Proposition 65 also prohibits businesses from knowingly and intentionally exposing any individual to a chemical known to the state to cause cancer or reproductive toxicity, without first giving clear and reasonable warning, which can take the form of product labels or notices. The Office of Environmental Health Hazard Assessment (OEHHA) administers the Proposition 65 program, including an evaluation of all currently available scientific information on substances considered for placement on the Proposition 65 list.

OEHHA has established safe harbor levels for many of the chemicals on the Proposition 65 list. Exposure levels that are below these safe harbor levels are exempt from the requirements of Proposition 65. The safe harbor levels for the heavy metals specified in AB 899 are 10 μg/day for arsenic, 4.1 μg/day for cadmium, and 15 μg/day for lead and lead compounds. No safe harbor level has been specified for mercury; businesses that expose individuals to mercury are required to provide a Proposition 65 warning, unless they can show that the anticipated exposure level will not pose a significant risk of cancer or reproductive harm. 

In 2018, California Attorney General Xavier Becerra announced the issuance of two cease and desist letters and a lawsuit filed against two businesses, Nutraceutical Corp. and Graceleigh Inc., due to the discovery of dangerously elevated levels of lead in their toddler formulas (formulas that are generally intended for children over 12 months of age). Testing conducted by the California Department of Justice on two products—Peaceful Planet Toddler Supreme and Sammy’s Milk Free-Range Goat Milk Toddler Formula—revealed that these formulas contained enough lead to result in exposure between 13 and 15 times the level allowed under California law without a Proposition 65 warning. Both formulas also exceeded the FDA's PTTDI.  In the lawsuit, the Attorney General alleged that the two companies had violated California’s Unfair Competition Law, False Advertising Law, and Proposition 65. In response to the lawsuit, the two companies pulled the products out of California.

Also in 2018, the Attorney General and ten district attorneys filed a lawsuit against Perrigo Company after testing showed that the company's infant and toddler formula products contained levels of lead that exceeded the Proposition 65 warning threshold.  In 2022, the Attorney General announced a settlement with Perrigo Company that sets maximum lead levels of 5-7 ppb for most of these products, levels that are much lower than applicable guidance levels established for this type of product by any U.S. regulatory authority.

AB 899 requires that manufacturers post on their internet websites the names and levels for heavy metals detected in their infant formula and baby food products, but does not specify that this information must be posted in conjunction with information about standards for these chemicals. Without this information, parents and caregivers may not know how to interpret manufacturers' findings on heavy metal levels; this could be especially problematic for families with babies who rely on infant formula as their primary source of nutrition. The author may wish to consider adding a requirement that manufacturers also post information about applicable standards for heavy metals in baby food and infant formula established by the FDA, to help parents and caregivers contextualize and understand information about the posted levels and their risks. Where FDA standards do not currently exist or are under development for a particular heavy metal, the author could consider specifying a different standard, such as those established under Proposition 65.

Heavy metals in infant formula and baby food: Several reports and investigations have documented the presence of heavy metals in baby food and infant formula. Below is an overview of this documentation.

• Baby food: On November 6, 2019, the Subcommittee on Economic and Consumer Policy (Subcommittee; part of the Committee on Oversight and Reform at the U.S. House of Representatives) acted on reports alleging high levels of toxic heavy metals in baby foods by requesting internal documents and test results from seven of the largest manufactures of baby food in the U.S. The manufacturers were:
  • Nurture, Inc., which sells Happy Family Organics, including baby food products under the brand name HappyBABY;
  • Beech-Nut Nutrition Company;
  • Hain Celestial Group, Inc., which sells baby food products under the brand name Earth’s Best Organic;
  • Gerber;
  • Campbell Soup Company, which sells baby food under the name Plum Organics;
  • Walmart Inc.; and,
  • Sprout Foods, Inc.

Four of the companies responded to the subcommittee’s requests and produced internal testing policies and test results for ingredients/finished products and documentation about what the companies did with ingredients/finished products that exceeded their internal testing limits. However, Walmart, Campbell, and Sprout Organics Foods refused to cooperate with the subcommittee’s investigation.

On February 4, 2021, the Subcommittee released the report, "Baby foods are tainted with dangerous levels of arsenic, lead, cadmium, and mercury," which details findings from its investigation. Findings include:

• • Commercial baby foods are tainted with significant levels of toxic heavy metals, including arsenic, lead, cadmium, and mercury. Exposure to toxic heavy metals causes permanent decreases in IQ, diminished future economic productivity, and increased risk of future criminal and antisocial behavior. Toxic heavy metals endanger infant neurological development and long-term brain function;
    
  • Arsenic, lead, and cadmium were present in baby foods made by all of the responding companies, and mercury was detected in baby food of the only responding company that tested for it. Nurture sold finished baby food products containing as much as 10 ppb mercury, Beech-Nut and Hain did not test for mercury, and Gerber rarely tested for mercury in its baby foods;
  • Internal company standards permit dangerously high levels of toxic heavy metals. Documents revealed that the manufacturers have often sold foods that exceeded FDA levels (where levels have been established) and that have, in some cases, even exceeded manufacturers' own internal standards. In some instances, manufacturers' internal standards were higher than the FDA limit. For example, although the FDA has a standard of 100 ppb inorganic arsenic in infant rice cereal, Nurture set its internal standard for that product 15% higher than the FDA limit;
    
  • The Subcommittee expressed grave concerns about baby food products produced by Walmart, Sprouts, and Campbell, which refused to cooperate with the Subcommittee, and that their lack of cooperation might obscure the presence of even higher levels of toxic heavy metals in their baby products, compared to their competitors’ products; and,
  • In 2019, industry shared information with federal regulators, but not the general public, that revealed corporate policies to test only ingredients, not final products, a practice that may underrepresent the levels of toxic heavy metals in baby foods. The information also revealed that baby food producers may be adding ingredients that have high levels of toxic heavy metals into their products, such as vitamin/mineral pre-mix.

Based on its findings, the Subcommittee issued the recommendations listed below. The first two—mandatory testing and labeling—are consistent with requirements established in AB 899.

• Mandatory testing: Baby food manufacturers should be required by the FDA to test their finished products for toxic heavy metals, not just their ingredients;
• Labeling: Manufacturers should be required by the FDA to report levels of toxic heavy metals on food labels;
• Voluntary phase-out of toxic ingredients: Manufacturers should voluntarily find substitutes for ingredients that are high in toxic heavy metals, or phase out ingredients that have high amounts of toxic heavy metals, such as rice;
• Standards: The FDA should set maximum levels of toxic heavy metals permitted in baby foods; and,
• Parental vigilance. Parents should avoid baby foods that contain ingredients testing high in toxic heavy metals, such as rice products.

In July 2022, the FDA released a report that summarizes analytical results for elements in food, through its Total Diet Study (TDS) for fiscal years 2018 through 2020. The TDS is a continuous survey and one of the tools the FDA uses to monitor the country's food supply. For the TDS, FDA collects foods from retail outlets and measures concentrations of various nutrients and contaminants in food. In fiscal year 2019, additional sampling of baby foods was conducted as part of TDS. The FDA found that:

• • The foods with the highest mean lead concentrations were baby food sweet potatoes, baby food teething biscuits, and sandwich cookies.
• Approximately 51% of the baby food samples analyzed had detectable levels of total arsenic. The highest levels of total arsenic were found in infant cereals and snacks like teething biscuits and puffed snacks.
  • The highest level (49 ppb) of cadmium in baby food was in a sample containing spinach as an ingredient. The second highest result for cadmium was 41 ppb in baby food carrots.
  • The highest mean mercury concentrations were found in fish; mercury was not detected in 97% of baby food samples.
• Infant formula: In 2017, the Clean Label Project released findings from an investigation of heavy metal levels in over 530 baby and toddler food products, including formulas, cereals, jars, pouches, juices, drinks, and snacks. The organization reports that lead was detectable in 36% of the products; cadmium was detected in 58% of the products; soy-based formulas contained seven times the amount of cadmium as compared to other formulas; and, arsenic was detected in 65% of all products tested and found in nearly 80% of the formulas tested. It does not appear that the majority of these findings were published in a peer-reviewed journal, and it is difficult, based on materials available on Clean Label Project's website, to assess the investigation's methodology.

In 2019, an author associated with the Clean Label Project co-published a peer-reviewed article entitled "Lead and cadmium contamination in a large sample of United States infant formulas and baby foods," in Science of the Total Environment. This article appears to present a subset of findings from the Clean Label Project's investigation. The article contains the following findings: out of 91 infant formula samples, 22% exceeded Proposition 65 lead guidelines; 23% exceeded Proposition 65 cadmium guidelines; and, 14% exceeded the tolerable cadmium intake levels established by the World Health Organization for a four-month-old baby.

This bill: AB 899 requires manufacturers of infant formula or baby food to test their final infant formula or baby food product for toxic heavy metals, including lead, mercury, cadmium, and arsenic. The bill also requires manufacturers to post on their websites the names and levels of toxic heavy metals present in their product, and to disclose on a product label that the product has been tested for a toxic heavy metal and, if applicable, is within FDA guidance for that metal. The bill's testing and product disclosure requirements act on recommendations made by the United States House of Representatives Subcommittee on Economic and Consumer Policy, and could help provide a level of transparency about heavy metal contamination in baby food and infant formula that is not currently available parents and caregivers.

Arguments in support: According to the American Academy of Pediatrics, California:

"In September 2021, the US House of Representatives Subcommittee on Economic and Consumer Policy released a report detailing concerning levels of heavy metals in baby food products. The report found products from multiple leading baby food producers in violation of FDA heavy metal limits, specifically in regard to arsenic levels in rice products.

While compiling the 2021 report, investigators found that some companies were not testing their finished food products at all. Instead, manufacturers were testing heavy metal levels in ingredients and using those levels to estimate levels in finished products. This method was determined to understate the toxic heavy metal levels in finished products. The Subcommittee recommended that manufacturers be required to test their final products for heavy metal levels, not just their ingredients. The Subcommittee also recommended that manufacturers be required to report levels of heavy metals in their products.

In June 2021, public health officials in the State of Alaska found that multiple samples of Beech-Nut and Gerber’s infant rice cereals exceeded the FDA’s 100 parts per billion (ppb) limits for inorganic arsenic in infant rice cereal. Beech-Nut had tested the rice flour used to make the rice cereal and found arsenic levels below the FDA guidance levels, highlighting the ineffectiveness of ingredient-only testing.

Researchers find repeatedly that heavy metals are detrimental to cognitive development. Exposure to heavy metals at an early age has been linked to lower IQs, behavior problems, cardiovascular issues, and attention deficit hyperactivity disorder. In 2017, researchers at Duke University studied 565 adults who had their lead levels measured as children. Those with high childhood lead readings had IQ levels 4.25 points lower on average.

AB 899 acts on recommendations made by the Subcommittee on Economic and Consumer Policy and empowers parents by requiring manufacturers to test for and publicize levels of toxic heavy metals in their baby food and infant formula products."

Comments in concern: According to the Infant Nutrition Council of America (an association comprised of Abbott Nutrition, Perrigo Nutrition, and Reckitt, all manufacturers of infant formulas and toddler milks):

"AB 899 proposes that infant formula manufacturers test and make public the results of lead, mercury, cadmium, and arsenic results. The required public posting of infant formula test results in the absence of federal guidance and a federal action level for these metals would create significant confusion among parents and caregivers and result in mistrust of fully compliant and safe infant formulas available on the market. We do not recommend any actions that might erode confidence in U.S. infant formula products and unintentionally create fear and panic that could further strain the availability of safe infant formula products that meet all FDA regulatory requirements.

Further, AB 899 would require a label change for infant formulas to denote the product has been tested for heavy toxic metals when FDA establishes industry guidance for such testing. This could equally result in confusion for consumers if they expect that every can of infant formula has been sampled and tested as opposed to a representative sample across the batch. It is impossible to test each can and still have product to distribute to the market. Further, while other testing is required of infant formula, there are no labeling provisions to denote as such. This creates an inequitable view of the infant formula regulations and could create trade issues across the United States.

AB 899 proposes requirements prior to allowing FDA experts to establish appropriate action levels, and could create confusion related to safe, nutritious infant formulas currently on the market."

Arguments in opposition: None on file.

Related legislation:

1. AB 228 (Wilson). Requires CDPH and the Office of Emergency Services, in coordination with other state agencies, to establish an infant formula stockpile. This bill is pending action in the Assembly Appropriations Committee.
2. AB 418 (Gabriel). Prohibits, commencing January 1, 2025, a person or entity from manufacturing, selling, delivering, distributing, holding, or offering for sale, in commerce a food product that contains any of the following substances: brominated vegetable oil, potassium bromate, propylparaben, red dye 3, and titanium dioxide. This bill is currently pending action in the Assembly Environmental Safety and Toxic Materials Committee.
3. AB 100 (Holden, Chapter 692, Statutes of 2021). Requires, commencing January 1, 2023, manufacturer compliance with a specified lower lead leaching standard for faucets and other end point devices used for providing drinking water, and prohibits all sales of such products that do not meet the new standard beginning July 1, 2023. Requires labeling of products that comply with the definition of "lead free" to indicate compliance in an easily identifiable manner.
4. AB 1200 (Ting, Chapter 503, Statutes of 2021). Prohibits, commencing January 1, 2023, the sale of food packaging that contains PFAS; requires, commencing January 1, 2024, cookware manufacturers to label their product if it contains an intentionally added chemical on specified lists; and prohibits, commencing January 1, 2023, for the internet and January 1, 2024, for cookware packaging, a cookware manufacturer from making a claim that cookware is free of a chemical, unless no chemical from that chemical class is intentionally added to the cookware.
5. AB 1316 (Quirk, Chapter 507, Statutes of 2017). Requires CDPH to revise its regulations for the Childhood Lead Poisoning Prevention Program to redefine the assessment of risks for the purposes of evaluating a child's risk for lead exposure.
6. SB 258 (Lara, Chapter 830, Statutes of 2017). Creates the Cleaning Product Right to Know Act of 2017, which requires manufacturers of cleaning products to disclose specified chemical ingredients on a product label and on the manufacturers’ website.
7. SB 1019 (Leno, Chapter 862, 2014). Requires manufacturers of upholstered furniture to indicate, on a label currently required by law, whether or not the product contains added flame retardant chemicals.

REGISTERED SUPPORT / OPPOSITION:

Support

American Academy of Pediatrics, California
Center for Food Safety; the
Consumer Attorneys of California
Educate. Advocate.
Environmental Working Group

Opposition

None on file.

Analysis Prepared by: Naomi Ondrasek / E.S. & T.M. /

Date of Hearing: March 28, 2023

ASSEMBLY COMMITTEE ON HEALTH

Jim Wood, Chair

ABPCA Bill Id:AB 899

Author:(Muratsuchi) – As Amended Ver:March 13, 2023

SUBJECT: Food safety: infant formula and baby food.

SUMMARY: Requires in-state or out-of-state manufacturers of infant formula or baby food sold or distributed in this state to: 1) test their infant formula or baby food products for toxic heavy metals, including levels of lead, mercury, cadmium, and arsenic; 2) post on their website the name and level of toxic heavy metals in the final infant formula or baby food product; and, 3) include a label on the product that it has been tested. Specifically, this bill:

1. Requires an in-state or out-of-state manufacturer of infant formula or baby food for sale or distribution in this state to do the following:
   1. Test their final infant formula or baby food product for toxic heavy metals, including levels of lead, mercury, cadmium, and arsenic;
   2. Make publicly available on their internet website the name and level of toxic heavy metals present in the final infant formula or baby food product; and,
   3. For infant formula or baby food products for which the federal Food and Drug Administration (FDA) has adopted industry guidance for levels of a certain toxic heavy metal, include a label on the product that it has been tested for that toxic heavy metal and is within the FDA guidance.
      
2. Defines final infant formula or baby food product to mean the finished product of infant formula or baby food as opposed to the constituent ingredients of infant formula or baby food.
   
3. Permits a manufacturer to test their final infant formula or baby food product before packaging individual units of infant formula or baby food for sale or distribution.

EXISTING LAW:

1. Defines, under federal law, infant formula to mean a food which purports to be or is represented for special dietary use solely as a food for infants by reason of its simulation of human milk or its suitability as a complete or partial substitute for human milk. [21 United States Code Section (§) 321(z)]
2. Establishes the Sherman Food, Drug and Cosmetics Law (Sherman Law), administered by the California Department of Public Health (DPH), which regulates the packaging, labeling, and advertising of drugs and devices, including dietary supplements. [Health & Safety Code (HSC) Sections 109875-111929.4]
3. Adopts, under Sherman Law, the federal definition of infant formula. Requires DPH to review all changes to the federal definition of infant formula before those changes are incorporated by reference to the Sherman Law, as specified. [HSC §109951]
4. Defines the following under the Sherman Law:
   1. A label to mean a display of written, printed, or graphic matter upon a food, drug, device, or cosmetic or upon its immediate container. [HSC §109955]
   2. Manufacture to mean the preparation, compounding, propagation, processing, or fabrication of any food, drug, device, or cosmetic. The term “manufacture” includes repackaging or otherwise changing the container, wrapper, or labeling of any food, drug, device, or cosmetic in furtherance of the distribution of the food, drug, device, or cosmetic. The term “manufacture” does not include repackaging from a bulk container by a retailer at the time of sale to its ultimate consumer. [HSC §109970]
5. Requires all labels of foods, drugs, devices, or cosmetics to conform to federal requirements, as specified. [HSC §110340]
6. Establishes, through the initiative process, Proposition 65, commonly known as the Safe Drinking Water and Toxic Enforcement Act of 1986, which requires businesses to provide warnings to Californians about significant exposures to chemicals that cause cancer, birth defects, or other reproductive harm. Specifies that these chemicals can be in the products that Californians purchase, in their homes or workplaces, or that are released into the environment. Proposition 65 also prohibits California businesses from knowingly discharging significant amounts of listed chemicals into sources of drinking water. Proposition 65 requires California to publish a list of chemicals known to cause cancer, birth defects or other reproductive harm. This list, which must be updated at least once a year, has grown to include approximately 900 chemicals since it was first published in 1987. [HSC §25249.5 - 25249.14]

FISCAL EFFECT: Unknown. This bill has not yet been analyzed by a fiscal committee.

COMMENTS:

1. PURPOSE OF THIS BILL. According to the author, this bill protects babies from harmful toxins. In September 2021, the United States House of Representatives Subcommittee on Economic and Consumer Policy released a report detailing concerning levels of heavy metals in baby food products. The report found products from multiple leading baby food producers in violation of FDA heavy metal limits, specifically in regards to arsenic levels in rice products. The Subcommittee recommended that manufacturers be required by the FDA to test final products for heavy metal levels, not just test their ingredients. The Subcommittee also recommended that manufacturers be required to report levels of heavy metals in their products. The author concludes this bill acts on these recommendations and empowers parents by requiring baby formula and baby food manufacturers to test their finished products for heavy metal levels and to make publicly available on their website the name and level of toxic heavy metals present in the final product.
2. BACKGROUND. According to market estimates, the U.S. baby food market was valued at $12.9 billion in 2018 and is projected to reach $17.2 billion by 2026. According to a Consumer Reports survey, in the U.S. more than 90% of parents with children three and under turn to these foods at least occasionally. However, there is growing concern than many commercial baby food products are tainted with dangerous levels of arsenic, lead, cadmium and mercury.
   
   1. Regulation of infant formula. The FDA requires infant formula manufacturers to comply with the Federal Food, Drug and Cosmetic Act (FDCA). FDCA includes certain requirements relating to nutrient content, nutrient quantity, nutrient quality control, recordkeeping, reporting, and recall of infant formulas. In addition, the FDCA requires persons responsible for the manufacture or distribution of infant formula to register with FDA and to make a submission to the FDA for any new infant formula, which includes any infant formula that has had a major change in its formulation or processing, 90 days before any charitable or commercial distribution. After the first processing of a new infant formula, but before marketing, persons responsible for the manufacture or distribution of infant formula must submit to the FDA a written verification which demonstrates that the formula, as actually produced, complies with the FDCA's requirements. A summary of test results of nutrients in the formula is required. Under the authority of the FDCA, the FDA has promulgated regulations that specify infant formula nutrient quality control procedures; records and reports; and submission requirements; the labeling of infant formula; the terms and conditions under which certain infant formula may be exempt from some of the FDCA’s requirements; nutrient specifications for infant formula; and infant formula recalls. In 2014, the agency revised its infant formula regulations to establish quality factors, current good manufacturing practices, and revised quality control procedures. In the United States, baby food is treated similarly to adult foods.
      
   2. Heavy Metals in Baby Food. On November 6, 2019, following reports alleging high levels of toxic heavy metals in baby foods, the Subcommittee on Economic and Consumer Policy Committee on Oversight and Reform at the U.S. House of Representatives (Subcommittee) requested internal documents and test results from seven of the largest manufactures of baby food in the United States:
3. Nurture, Inc. which sells Happy Family Organics, including baby food products under the brand name HappyBABY;
4. Beech-Nut Nutrition Company;
5. Hain Celestial Group, Inc. which sells baby food products under the brand name Earth’s Best Organic;
6. Gerber;
7. Campbell Soup Company, which sells baby food under the name Plum Organics;
8. Walmart Inc.; and,
9. Sprout Foods, Inc. (Sprout Organics Foods).

Four of the companies responded to the subcommittee’s requests and produced internal testing policies and test results for ingredients/finished products and documentation about what the companies did with ingredients/finished products that exceeded their internal testing limits. However, Walmart, Campbell, and Sprout Organics Foods refused to cooperate with the subcommittee’s investigation.

On February 4, 2021, the Subcommittee released its report (report) which includes the following findings.

• • 1. Commercial baby foods are tainted with significant levels of toxic heavy metals, including arsenic, lead, cadmium, and mercury. Exposure to toxic heavy metals causes permanent decreases in IQ, diminished future economic productivity, and increased risk of future criminal and antisocial behavior in children. Toxic heavy metals endanger infant neurological development and long-term brain function;
       
    2. Internal company standards permit dangerously high levels of toxic heavy metals, and documents revealed that the manufacturers often sold foods that exceeded the Food and Drug Administration (FDA) levels; and,
       
    3. The Subcommittee has grave concerns about baby food products produced by Walmart, Sprouts, and Campbell which refused to cooperate with the Subcommittee, and that their lack of cooperation might obscure the presence of even higher levels of toxic heavy metals in their baby products, compared to their competitors’ products.

The Subcommittee also pointed out that corporate policies to test only ingredients, not final products underrepresent the levels of toxic heavy metals in baby foods; naturally occurring toxic heavy metals may not be the only problem causing the unsafe levels of toxic heavy metals in baby foods; rather baby food producers may be adding ingredients that have high levels of toxic heavy metals into their products, such as vitamin/mineral pre-mix; and that only final product testing can measure the true danger posed by baby foods.

• 1. Subcommittee’s Recommendations. The Subcommittee made the following recommendations:
     1. Mandatory testing. Baby Food manufacturers should be required by the FDA to test their finished products for toxic heavy metals, not just their ingredients.
     2. Labeling. Manufacturers should be required by the FDA to report levels of toxic heavy metals on food labels;
     3. Voluntary phase-out of toxic ingredients. Manufacturers should voluntarily find substitutes for ingredients that are high in toxic heavy metals, or phase out ingredients that have high amounts of toxic heavy metals, such as rice.
     4. Standards. The FDA should set maximum levels of toxic heavy metals permitted in baby foods.
     5. Parental vigilance. Parents should avoid baby foods that contain ingredients testing high in toxic heavy metals, such as rice products.
        
  2. Description of Heavy Metals in Baby Products. This bill specifically requires manufacturers to test for arsenic, lead, cadmium, and mercury. Below are description of these metals, as described by the Agency for Toxic Substances and Disease Registry (ATSDR) within the U.S. Health and Human Services Agency:
     
     1. Arsenic. Arsenic ranks number one on the ATSDR list of substances present in the environment that pose the most significant potential threat to human health. Arsenic is a naturally occurring element widely distributed in the earth's crust. In the environment, arsenic is combined with oxygen, chlorine, and sulfur to form inorganic arsenic compounds. Arsenic in animals and plants combines with carbon and hydrogen to form organic arsenic compounds. Inorganic arsenic compounds are mainly used to preserve wood. Organic arsenic compounds are used as pesticides, primarily on cotton plants.
        
        Breathing high levels of inorganic arsenic could cause sore throat or irritated lungs. Ingesting very high levels of arsenic can result in death. Exposure to lower levels can cause nausea and vomiting, decreased production of red and white blood cells, abnormal heart rhythm, damage to blood vessels, and a sensation of "pins and needles" in hands and feet. Ingesting or breathing low levels of inorganic arsenic for a long time can cause a darkening of the skin and the appearance of small "corns" or "warts" on the palms, soles, and torso. There is some evidence that long-term exposure to arsenic in children may result in lower IQ scores. There is also some evidence that exposure to arsenic in the womb and early childhood may increase mortality in young adults. There is also some evidence that inhaled or ingested arsenic can injure pregnant women or their unborn babies, although the studies are not definitive. Studies in animals show that large doses of arsenic that cause illness in pregnant females, can also cause low birth weight, fetal malformations, and even fetal death. Arsenic can cross the placenta and has been found in fetal tissues. Arsenic is also found at low levels in breast milk.
        
        The U.S. Environmental Protection Agency (EPA) has set limits on the amount of arsenic that industrial sources can release to the environment and has restricted or cancelled many of the uses of arsenic in pesticides. The EPA has set a limit of 0.01 parts per million (ppm) for arsenic in drinking water. The Occupational Safety and Health Administration (OSHA) has set a permissible exposure limit (PEL) of 10 micrograms of arsenic per cubic meter of workplace air (10 µg/m³) for eight hour shifts and 40 hour work weeks.
        
        According to the Subcommittee report, Nurture appears to be the only manufacturer that regularly tests its finished baby food products for inorganic arsenic content and the other manufacturers only tested their ingredients. It was reported that Nurture baby food products contained as much 180 parts per billion (ppb) inorganic arsenic, and over 25% of Nurture products tested before sale had over 100 ppb inorganic arsenic. Moreover, Hain sold finished baby products with as much as 129 ppb inorganic arsenic; Beech-Nut used ingredients after they tested as high as 913.4 ppb arsenic; and, Gerber used high-arsenic ingredients, using 67 batches of rice flour that had tested over 90 ppb inorganic arsenic.
        
     2. Lead. Lead is number two on ATSDR’s list of substances present in the environment that poses the most significant potential threat to human health. Lead is a metal found naturally in the earth's crust. It can be found in all parts of our environment, including air, water, and soil. Lead can combine with other chemicals to make different compounds. Lead is used in the production of batteries, ammunition, and metal products (solder and pipes). Because of health concerns, the use of lead in paints, ceramic products, caulking, and pipe solder has been dramatically reduced. The use of lead as an additive to automobile gasoline was banned in 1996 in the United States. The nervous system is the main target for lead poisoning in children and adults. Long-term exposure can result in decreased learning, memory, and attention, and weakness in fingers, wrists, or ankles. Lead exposure can cause anemia (low iron in the blood) and damage to the kidneys. It can also cause increases in blood pressure, particularly in middle-aged and older individuals. Exposure to high lead levels can severely damage the brain and kidneys and can cause death. In pregnant women, exposure to high levels of lead may cause a miscarriage. In men, it can cause damage to reproductive organs. Children are more vulnerable to lead poisoning than adults because their nervous system is still developing. Children can be exposed to lead in their environment and before birth from lead in their mother’s body. At lower levels of exposure, lead can decrease mental development, especially learning, intelligence, and behavior. Physical growth may also be decreased. A child who swallows large amounts of lead may develop anemia, severe stomachache, muscle weakness, and brain damage. Exposure to lead during pregnancy can also result in premature births. Some effects of lead poisoning in a child may continue into adulthood.
        
        The Subcommittee reported the following on lead: Nurture sold finished baby food products that tested as high as 641 ppb lead. Almost 20% of the finished baby food products Nurture tested contained over 10 ppb lead; Beech-Nut used ingredients containing as much as 886.9 ppb lead. It used many ingredients with high lead content, including 483 that contained over 5 ppb lead, 89 that contained over 15 ppb lead, and 57 that contained over 20 ppb lead; Hain (Earth’s Best Organic) used ingredients containing as much as 352 ppb lead. Hain used many ingredients with high lead content, including 88 that tested over 20 ppb lead and six that tested over 200 ppb lead; and, Gerber used ingredients that tested as high as 48 ppb lead; and used many ingredients containing over 20 ppb lead.
        
     3. Cadmium. Cadmium is a natural element in the earth's crust and is usually found as a mineral combined with other elements such as oxygen (cadmium oxide), chlorine (cadmium chloride), or sulfur (cadmium sulfate, cadmium sulfide). All soils and rocks, including coal and mineral fertilizers, contain some cadmium. Most cadmium used in the United States is extracted during the production of other metals like zinc, lead, and copper. Cadmium does not corrode easily and has many uses, including batteries, pigments, metal coatings, and plastics. Breathing high levels of cadmium can severely damage the lungs. Eating food or drinking water with very high levels of cadmium severely irritates the stomach, leading to vomiting and diarrhea. Long-term exposure to lower levels of cadmium in air, food, or water leads to a buildup of cadmium in the kidneys and possible kidney disease. Other long-term effects are lung damage and fragile bones. The health effects in children are expected to be similar to the effects seen in adults (kidney, lung, and bone damage depending on the route of exposure). A few studies in animals indicate that younger animals absorb more cadmium than adults. Animal studies also indicate that the young are more susceptible than adults to a loss of bone and decreased bone strength from exposure to cadmium. It is not known if cadmium causes birth defects in people. The babies of animals exposed to high levels of cadmium during pregnancy had changes in behavior and learning ability. There is also some information from animal studies that high enough exposures to cadmium before birth can reduce body weights and affect the skeleton in the developing young.
        
        The EPA has determined that exposure to cadmium in drinking water at concentrations of 0.04 ppm for up to 10 days is not expected to cause any adverse effects in a child. The EPA has determined that lifetime exposure to 0.005 ppm cadmium is not expected to cause any adverse effects. The FDA has determined that the cadmium concentration in bottled drinking water should not exceed 0.005 ppm. OSHA has limited workers' exposure to an average of 5 µg/m³ for an 8-hour workday, 40-hour workweek.
        
        The following were reported to the Subcommittee on cadmium: (1) Beech-Nut used 105 ingredients that tested over 20 ppb cadmium. Some tested much higher, up to 344.55 ppb cadmium; (2) Hain (Earth’s Best Organic) used 102 ingredients in its baby food that tested over 20 ppb cadmium. Some tested much higher, up to 260 ppb Cadmium; (3) Sixty-five percent of Nurture (HappyBABY) finished baby food products contained more than 5 ppb cadmium; and, (4) Seventy-five percent of Gerber’s carrots contained cadmium in excess of 5 ppb, with some containing up to 87 ppb cadmium.
        
     4. Mercury. Mercury is the third on ATSDR’s list of substances present in the environment that pose the most significant potential threat to human health. Mercury is a naturally occurring element, and elemental mercury is a silver liquid at room temperature that can also evaporate into the air as a gas or become a solid at very low temperatures. Mercury is used in a number of industries and products, primarily in the manufacturing of electronics, fluorescent-lighting, and production of chlorine-caustic soda. Most people are exposed to organic mercury compounds (typically methylmercury) in food (such as fish, seafood, rice) or to elemental mercury from dental fillings. Food is the most common form of exposure. Most people are not exposed to inorganic mercury salts. Industrial and dental workers who use mercury are primarily exposed to elemental mercury. Some cultures use mercury in traditional medicines or religious practices, although this is not recommended or approved for use in the United States. All forms of mercury can affect the nervous system and the kidneys. Workers exposed to elemental mercury vapor and people who eat foods with high levels of methylmercury experienced tremors, incoordination, impaired vision, impaired learning and memory, and mood changes. Some children born in communities that ate food with high levels of organic mercury had learning, sensory, and movement problems. In people exposed to high levels of methylmercury in their diets, birth defects have occurred. Some humans and animals that ate mercury compounds had high blood pressure and alterations in their immune systems. Animals that breathed elemental mercury vapor or ate organic or inorganic mercury compounds in their diets showed nervous system effects and/or kidney damage. Animals that ate high levels of mercury compounds showed decreased fertility and/or birth defects.
        
        The Subcommittee reported the following on mercury in baby food products: (1) Nurture (HappyBABY) sold finished baby food products containing as much as 10 ppb mercury; (2) Beech-Nut and Hain (Earth’s Best Organic) do not even test for mercury in baby food; and, (3) Gerber rarely tests for mercury in its baby foods.
        
  3. Closer to Zero Initiative. In April 2021, the FDA announced the Closer to Zero initiative that identifies actions the FDA will take to reduce exposure to toxic elements in foods eaten by babies and young children to lowest levels possible. FDA has prioritized babies and young children because their smaller body sizes and metabolism make them more vulnerable to the harmful effects of these contaminants. To meet the goals of Closer to Zero, the FDA will focus on: i) Research and Analysis: to include developing new and improved testing methods to measure lower levels of contaminants in food; identifying reference levels for these contaminants to determine levels of concern; conducting surveys on foods commonly eaten by infants and young children to understand variability in concentrations of arsenic, lead, cadmium, and mercury in these foods, and, understanding how nutrients can help protect against the health effects associated with contaminants; ii) Regulation: to include establishing action levels, and increasing targeted compliance and enforcement activities; and, iii) Consultation: to encourage adoption of agricultural and processing best practices by industry to lower levels of environmental contaminants in agricultural commodities and products. The FDA points out that reducing levels of contaminants in foods is complicated and multifaceted. It is crucial to ensure that measures taken to limit arsenic, lead, cadmium, and mercury in foods do not have unintended consequences—like eliminating from the marketplace foods that have significant nutritional benefits or reducing the presence of one element while increasing another.
     
     1. Lead levels in juice. The first step in the Closer to Zero initiative was the guidance on lead levels in juice issued by the FDA in April 2022. The draft guidance titled “Action Levels for Lead in Juice; Draft Guidance for Industry” provides an action level for lead in apple juice of 10 ppb, which is lower than the action level for lead in other juices of 20 ppb, because, as the most commonly consumed juice by young children, apple juice may contribute a greater share of their potential lead exposure than other juices. The FDA estimates establishing a 10 ppb action level for lead in apple juice could result in as much as a 46% reduction in exposure to lead from apple juice in children. For all other fruit and vegetable juices, establishing an action level of 20 ppb is estimated to result in a 19% reduction in exposure to lead from these juices in children.
        
     2. Lead levels in food. The second step undertaken by the FDA associated with the Closer to Zero initiative was announced on January 24, 2003 when the FDA issued for public comment “Action Levels for Lead in Food Intended for Babies and Young Children: Draft Guidance for Industry (Draft Guidance).” Foods covered by the Draft Guidance are those processed foods, such as food packaged in jars, pouches, tubs, and boxes, that are represented or purported to be specifically for babies and young children less than two years of age. Lead may be present in these foods because agricultural commodities they are made from—fruits, vegetables, grains, and animals— take up contaminants in the environment in much the same way they take up nutrients. In this way, these foods can provide nutrients essential for child growth and development, but they may also be a source of exposure to contaminants. The comment period for the Draft Guidance ends on March 27, 2023.
        
        The Draft Guidance proposes to establish the following action levels for lead in food labeled for babies and young children: 10 ppb for fruits, vegetables (excluding single-ingredient root vegetables), mixtures, yogurts, custards/puddings, and single-ingredient meats; 20 ppb for root vegetables (single ingredient); and, 20 ppb for dry infant cereals. These action levels would reflect levels of lead at which FDA may regard the food as adulterated within the meaning of the FDCA. The FDA is requesting comments on these proposed action levels in general, including on whether there may be sufficient data or information that would support lower levels for these categories of foods. For example, whether there is data or information that show adverse cognitive impacts in children at very low blood levels that could support a lower interim reference level for lead exposure through foods. The FDA is particularly interested in whether there is data and information that would support a lower action level for fruits, vegetables (excluding single-ingredient root vegetables), mixtures, yogurts, custards/puddings, and single-ingredient meats, since the FDA estimates that the achievability percentile (i.e., percentage of samples that fall at or below the action level) for this food category would be 90.6 percent if the action level were 5 ppb.
        

1. DOUBLE-REFERRAL. This bill is double referred; upon passage in this Committee, this bill will be referred to the Assembly Committee on Environmental Safety & Toxic Materials.
2. SUPPORT. The American Academy of Pediatrics, the Center for Food Safety, and the Consumer Attorneys of California write in support that researchers find repeatedly that heavy metals are detrimental to cognitive development. Exposure to heavy metals at an early age has been linked to lower IQs, behavior problems, cardiovascular issues, and attention deficit hyperactivity disorder. This bill acts on recommendations made by the Subcommittee and empowers parents by requiring manufacturers to test for and publicize levels of toxic heavy metals in their baby food and infant formula products.
3. CONCERNS. The Infant Nutrition Council of America (INCA), an association of U.S. manufacturers of infant formulas and toddler milks, has raised concerns about this bill and states that infant formula manufacturers test both ingredients and finished goods for the presence of heavy toxic metals, and meet or exceed standards set by the FDA and other entities. Consistent with federal regulations, infant formula manufacturers identify potential risks for and monitor heavy toxic metals across raw materials and finished product batches. INCA members look forward to working with FDA on establishing action levels for heavy toxic metals in infant formula which will bring improved transparency to the public on the measures already in place across the infant formula industry. This bill also proposes that infant formula manufacturers test and make public the results of lead, mercury, cadmium, and arsenic results. The required public posting of infant formula test results in the absence of federal guidance and a federal action level for these metals would create significant confusion among parents and caregivers and result in mistrust of fully compliant and safe infant formulas available on the market. INCA does not recommend any actions that might erode confidence in U.S. infant formula products and unintentionally create fear and panic that could further strain the availability of safe infant formula products that meet all FDA regulatory requirements. Further, this bill would require a label change for infant formulas to denote the product has been tested for heavy toxic metals when FDA establishes industry guidance for such testing. This could result in confusion for consumers if they expect that every can of infant formula has been sampled and tested as opposed to a representative sample across the batch. It is impossible to test each can and still have product to distribute to the market. This creates an inequitable view of the infant formula regulations and could create trade issues across the U.S.. INCA concludes that this bill proposes requirements prior to allowing FDA experts to establish appropriate action levels, and could create confusion related to safe, nutritious infant formulas currently on the market.
4. RELATED LEGISLATION.
   1. AB 228 (Wilson) requires DPH and the Office of Emergency Services, by January 1, 2025, in coordination with other state agencies as appropriate, to establish an infant formula stockpile, upon appropriation and as necessary. AB 228 is pending in Assembly Appropriations Committee.
   2. AB 660 (Irwin) changes the use of sell-by and use-by date of food products from a voluntary system to a requirement for food products sold in California, starting January 1, 2025. AB 660 is pending in Assembly Health Committee.
5. PREVIOUS LEGISLATION.
   1. AB 2279 (Cristina Garcia, Quirk, Reyes, and Salas) of 2020 would have, among other provisions, added several additional risk factors required to be considered as part of the standard of care for a lead poisoning evaluation of children required to be established by DPH in regulation, such as a child’s residency in or visit to a foreign country, their residency in a high-risk ZIP Code, and a child’s proximity to current or former lead-producing facilities. AB 2279 was not set for hearing due to the shortened Legislative calendar brought on by the COVID-19 pandemic.
   2. SB 1097 (Hueso), Chapter 691, Statutes of 2018, requires DPH’s report regarding the effectiveness of appropriate lead poisoning case management efforts to include additional data and information, as specified.
   3. AB 2976 (Quirk) would have required DPH to coordinate with the state entities, including DHCS, that are responsible for administering specified publicly funded programs to gather data to determine whether children are being screened for lead poisoning, as required pursuant to existing regulation. AB 2976 was held on the Senate Appropriations Committee suspense file.
   4. AB 247 (Garcia) of 2017 would have established a Statewide Lead Advisory Taskforce to review and provide recommendations regarding policies and procedures to reduce lead poisoning in the state. AB 247 was vetoed by the Governor who indicated: “The responsibilities of this task force would be duplicative of ongoing work by the Office of Environmental Health Hazard Assessment, DPH, the State Water Resources Control Board, and the Department of Toxic Substances Control. Coordination and evaluation of procedures to reduce childhood lead poisoning is being accomplished administratively amongst these agencies so there is no reason to divert resources to a task force.”
   5. AB 1316 (Quirk), Chapter 507, Statutes of 2017, requires DPH to revise its regulations for the CLPPP to redefine the assessment of risks for the purposes of evaluating a child's risk for lead exposure.
6. POLICY COMMENTS.
   1. Implementation date. This bill has an implementation date of January 1, 2024, however it is not clear how infant formula or baby products that are already on shelves before this bill’s implementation would be treated. As this bill moves forward, the author may wish to consider a delayed implementation date to allow food products that are already in the market to be sold.
   2. Labeling. The FDCA specifies certain requirements, including the information that must be included in the label of infant formulas. For example, the fluid ounces, the nutrients and amount of nutrients, minerals, and their amount are required to be included on the label. Moreover, statements like “infant formula with iron,” “additional iron may be necessary,” are included on the label, in addition to the “directions for preparation and use.” Similarly, the FDA regulates the label of packaged foods, including the information on net quantity, nutrition facts, ingredients, allergen declaration, and manufacturer information. However, it is not clear whether the FDA needs to approve an additional label on an infant formula or baby food products as this bill requires. As this bill moves forward, the author may wish to determine whether additional labels on infant formula or baby food products would need to be separately approved by the FDA since this bill applies only to products sold in California.
   3. Posting information on website. The FDA, under the Closer to Zero initiative, has adopted lead levels for juice and is working on finalizing lead levels in food. This bill requires manufacturers to make publicly available on their internet website the name and level of toxic heavy metals present in the final infant formula or baby food product. There is merit to the concern raised by manufacturers that this requirement could cause confusion among consumers on how to process the information that is presented. As this bill moves forward, the author may wish to consider requiring the posting of information on chemicals only where the FDA has adopted guidance.

REGISTERED SUPPORT / OPPOSITION:

Support

American Academy of Pediatrics

Center for Food Safety

Consumer Attorneys of California

Educate. Advocate.

Opposition

None on file.

Analysis Prepared by: Rosielyn Pulmano / HEALTH / (916) 319-2097