Public Workshop for Orthophthalates and Bisphenol A and

Public Workshop for: Ortho-phthalates and Bisphenol A, and Their Alternatives in Food Packaging November 19, 2019 9: 00 AM – 12: 00 PM Department of Toxic Substances Control Cal. EPA

Thank you for participating § You may access today’s presentation as well as public background documents on the DTSC Safer Consumer Products Workshops and Webinars page at: https: //dtsc. ca. gov/scp/safer-consumer-productsworkshops-events/ § For those of you viewing the presentation on the Web, you may ask questions or make comments via Safer. Consumer. Products@dtsc. ca. gov. § Public comment period opens today on Cal. SAFER and will run until December 19, 2019. 2

Safer Consumer Products framework As designated by 23 authoritative bodies DTSC selects Product-Chemical combinations that may cause harm Manufacturer evaluation of alternatives DTSC considers range of possible responses 3 California Code of Regulations, title 22 Chapter 55. Safer Consumer Products Sections 69501 through 69510

Food Packaging § What do we mean by Food Packaging? § Food packaging was defined in our 2018 -2020 Priority Product Workplan as: “Any product that is used to package hot, cold, frozen, or room-temperature food or beverage items for sale to restaurants and grocery stores or for retail sale to consumers. ” 4

Ortho-Phthalates in Food Packaging Rob Brushia, Ph. D. , Research Scientist III Safer Consumer Products Program Robert. Brushia@dtsc. ca. gov Department of Toxic Substances Control Cal. EPA

Topics § What are Ortho-phthalates (OPs)? § Why are we concerned with OPs in food packaging? § Questions for stakeholders 6

What are OPs? § OPs are dialkyl or alkyl esters of 1, 2 -benzenedicarboxylic acid § All OPs are captured as a “group” or class on DTSC’s Candidate Chemical List 7

The use of OPs in food packaging § “Plasticizers” make hard, brittle plastics (especially PVC) more flexible and durable § Trends in biomonitoring data suggest the use of OPs in food packaging is decreasing § A recent study confirmed OPs are still in some food packaging products* *Carlos, Katherine S. , Lowri S. de Jager, and Timothy H. Begley. 2018. “Investigation of the Primary Plasticisers Present in Polyvinyl Chloride (PVC) Products Currently Authorized as Food Contact Materials. ” Food Additives & Contaminants: Part A 35 (6): 1214– 22. 8

What types of packaging contain OPs? § The paper by Carlos et al. suggests OPs are still being used in cap gaskets: • 50% of the cap gaskets for non-alcoholic bottled beverages tested contained an OP • 67% of the cap gaskets for bottled beers contained an OP • 17% of packaged food jar cap gaskets contained an OP (two manufactured in the U. S. , one imported from Mexico, and one imported from India) 9

Why are we concerned with OPs? § Diet is considered a major exposure pathway § Biomonitoring has shown widespread human exposure § Hazard Considerations • Developmental and reproductive toxicity, • • carcinogenicity, mutagencity* Endocrine disruption Sensitive subpopulations may include children, pregnant women, and workers. § Some have been banned in certain children’s products *See California Code of Regulations, title 22, sections 69402. 6(a) and 69402. 6(b)(5) 10

A word about alternatives to OPs § It has been suggested that some manufacturers are switching from OPs to alternative plasticizers § Diethylhexyl adipate (DEHA*), appears to be a common alternative • Observed in PVC food service wraps, and gaskets of caps for non-alcoholic bottled beverages. *DEHA is on DTSC’s candidate chemical list due to reproductive and developmental toxicity. . 11

Discussion Questions § Manufacturing • Who manufacturers food packaging (e. g. , PVC laminates, bottle cap liners, pouches, bottles, can liners, etc. ) that contains OPs? • Are there any food packaging manufacturers in California that make products with OPs? • Which OPs are currently used in food packaging and what products are they used in? • What alternatives to OPs are being used in food packaging? 12

Discussion Questions § Supply Chain • Who manufactures and supplies the OPs to food packaging manufacturers? • Are there intermediaries (converters) involved who take materials (e. g. , PVC film, paperboard, etc) and assemble into a final food package product? • Are there manufacturers of OP-containing food packaging found in the California market that are located outside the United States, and if so, who are they, and where are they located? 13

Discussion Questions § Market • Who in California purchases and uses packaging that may contain OPs? • How much OP-containing food packaging, and what types, is on the market in California? • Who makes bottle caps and gaskets sold in California that contain OPs? 14

Thank you If you have questions, feel free to contact me: Rob Brushia (916)-324 -0805 Robert. Brushia@dtsc. ca. gov 15

Ortho-phthalates in Food Packaging: FVA perspective Flexible Vinyl Alliance Department of Toxic Substances Control Cal. EPA

What is the Flexible Vinyl Alliance? The FVA is a coalition of trade organizations, materials suppliers, compounders, formulators, molders and fabricators, who are currently concerned with regulatory and legislative attempts to debate, limit or “de-select” flexible vinyl products in commerce. The FVA provides messaging and advocacy on the proven safety, economy and utility of flexible PVC, a material used in a wide range of health care, recreational, military, automotive, building, flooring, construction and packaging applications.

Which OPs are currently used in food packaging and what products are they used in?

Only four (4) OPs are currently used in food contact applications in the US FDA publishes US OP food packaging survey – limited use for DINP, DIDP, DEHP FDA files industry abandonment petition 2018 2016 2019 Mar FDA expected to announce decision Food additive petition to revoke clearances for 30 OPs filed DINP Jul Nov Industry files FAP – 26 OPs no longer used in food contact DIDP Apr FDA indicates it is close to finalizing its decision on industry FAP DEHP DCHP TBD

FDA confirms that OPs have limited use in food packaging Uses consistent with existing FDA clearances for DINP (21 CFR § 178. 3740), DIDP (21 CFR § 177. 1210 & 177. 2600), DEHP (21 CFR § 177. 1210) and DCHP (21 § CFR 175. 105) Conveyor belts (non-fatty food) Industrial tubing (non-fatty food) Sealing gaskets (non-fatty food/low alcohol) Component of adhesive labels for exterior of PP food containers

FDA & Health Canada confirms that OPs are not used in food wraps and films

The United States is not an outlier in permitting the safe use of OPs in food contact No official positives list DINP & DIDP not a food safety concern Canada US q DINP – 21 CFR § 178. 3740 q DIDP – 21 CFR § 177. 1210 Plasticizer food contact plastics & packaging inks DINP & DIDP added to positives list draft Japan EU Swiss FSVO Plasticizer in single-use and repeated use materials & 177. 2600 Plasticizer in single-use and repeated use materials Mercosur South Korea China Permitted for use Additives in food contact PVC Australia and New Zealand No food packaging regulation DINP & DIDP not a food safety concern

DTSC can avoid duplicative efforts by waiting until the FDA phthalate review is complete “DTSC recognizes that products in this category may already be subject to complex regulatory requirements implemented by a number of authoritative bodies, including local governments, the U. S. Food and Drug Administration, the U. S. Department of Agriculture, the California Department of Public Health, Cal. Recycle, and others -- It is not DTSC's intent to duplicate or conflict with any existing statutory or regulatory requirements”

Summary Ortho-phthalates are permitted for safe use in food contact applications around the world Ortho-phthalate use in food contact or packaging in the United States is minimal Ortho-phthalates are used only in narrow food contact applications – they are not used in food wraps DTSC should consider awaiting the outcome of the FDA phthalate review

Public Workshop: BPA and Its Alternatives in Food Packaging Products Chris Leonetti, Ph. D. , Environmental Scientist Safer Consumer Products Program Christopher. Leonetti@dtsc. ca. gov Department of Toxic Substances Control Cal. EPA

Today’s Discussion § What is BPA and how is it used in food packaging § What is the relative safety and exposure potential of chemicals used in food and beverage can liners? § What are the alternatives to BPA and how are they used in food packaging? § Following the presentation, please engage with us and provide input § Public comment period open for 30 days from today’s date. You may provide written comment to us via the Cal. SAFER website https: //calsafer. dtsc. ca. gov/ 26

Bisphenol A: Use in Food Packaging Products § Epoxy-based resins (used in can linings) • • Food cans (soup, vegetables, etc. ) Beverage cans (soda, juice, beer) Lids with linings (glass jar lids, bottle caps) Other packaging linings § We have limited knowledge of where BPA is still used in food packaging Figure 1. Polymerized BPA used in epoxy-based resins 27

Bisphenol A Alternatives: Use in Food Packaging Products § There are numerous alternatives to BPA for the manufacturing of liners used in food packaging applications § Many BPA alternatives are known to exhibit similar hazard trait profiles as BPA and represent regrettable substitutions § There is little industry transparency on what chemical alternatives are used in place of BPA § We have limited knowledge of: • What chemicals are used in “BPA-free” food packaging products • Are different alternatives used in different food packaging applications? 28

Bisphenol A: Human Exposure § Widespread biological and environmental detection • Biological detection in all tissue types § Near ubiquitous human exposure – indicates that BPA is migrating from consumer products § Diet is primary route of BPA exposure for humans § BPA migrates out of food packaging containers and/or linings and contaminates food items Consuming foods or drinks that contain BPA because they have been in contact with some types of: - Metal food or drink cans, jar lids, or bottle caps - Polycarbonate plastic tableware or cookware Bisphenol A (BPA) exposure Swallowi ng, touching or breathing BPA in dust. - Polycarbonate plastic baby bottles or sippy cups made Figure 2. BPA exposure sources before July 2012 (from OEHHA Prop 65 factsheet) - Plastic wrap 29

Bisphenol A: Hazard Traits SCP Candidate Chemical Authoritative Listings § California Environmental Contaminant Biomonitoring Program (CECBP) Priority Chemicals: • Developmental Tox • Endocrine Tox • Reproductive Tox § EC Annex VI - Carcinogenic, Mutagenic, or Toxic for Reproduction: • Reproductive Tox Category 1 B § Proposition 65: • Reproductive Tox § National Toxicology Program Office of Health Assessment and Translation: • Developmental Tox • Reproductive Tox § Centers for Disease Control 4 th National Exposure Report: • Reproductive Tox 30

Bisphenol A: Adverse Impacts Bisphenol A § BPA is an endocrine disrupting compound (EDC): • Oestrogen-mediated pathways – structural similarity to E 2 § Human epidemiology studies collectively suggest adverse health outcomes: • Reproductive and developmental effects (infertility) • Metabolic disease (obesogenic effects) • Neurodevelopment and behavioral effects (anxiety, depression, hyperactivity) • Cardiovascular effects (heart disease, heart attack, hypertension) • Immunotoxicity • Certain types of cancer § Biologically active at very low concentrations 31

Other Bisphenols and Alternatives § Other bisphenol analogues show similar EDC capacities and potential human health concerns Bisphenol F § The CC List currently contains 12 bisphenols and 3 bisphenol-like chemicals Bisphenol S § We have only included BPS and BPF in our preliminary scoping due to the amount of peer-reviewed literature available Glycidyl methacrylate 32

Other Bisphenols and Alternatives § We have also included a reported BPA substitute – glycidyl methacrylate (also on the CC List) Bisphenol F • Carcinogenicity and Repro Tox 1 B (ECHA CMR) § Other liner materials: Bisphenol S • Acrylic resins • Plant-based resins • Polyester resins • Vinyls Glycidyl methacrylate 33

Stakeholder Questions § What types of food packaging currently contain BPA, other § § bisphenols, or bisphenol alternatives, and how much is sold in California? What alternatives to BPA/other bisphenols are used in food packaging? How has the safety of these alternatives been evaluated? What types of liners are used for food and beverage cans, respectively? Who are the manufacturers making food packaging products that contain BPA? Are any located in California? Who are the manufacturers buying and using food packaging products that contain BPA? Are they in California? 34

Comment Period § We will now begin the comment/discussion period § You may submit written comments until 11: 59 PM on December 19, 2019. You can submit comments via our Cal. SAFER website https: //calsafer. dtsc. ca. gov/ § If you have further questions, feel free to contact us at: Christopher Leonetti (916 -445 -6011) Christopher. Leonetti@dtsc. ca. gov Robert. Brushia@dtsc. ca. gov Thank you! 35

For those of you viewing the presentation on the Web, you may ask questions or make comments via Safer. Consumer. Products@dtsc. ca. gov 36