CerMA 2007: CerMA 2007 Proposition 65 & Regulatory Update


FDA Standards: FDA Standards MAXIMUM Pb LEACHING VALUES Tableware Food Contact Surfaces Type of Ware US FDA Flatware 3.0 ppm Small Holloware 2.0 ppm Large Holloware 1.0 ppm Cups, Mugs, Pitchers 0.5 ppm


FDA Standards: FDA Standards MAXIMUM Cd LEACHING VALUES Tableware Food Contact Surfaces Type of Ware US FDA Flatware 0.5 ppm Small Holloware 0.5 ppm Large Holloware 0.25 ppm


FDA/SGCD Lip Rim Standards: FDA/SGCD Lip Rim Standards Lip & Rim of Drinkware Rim and top 20 mm. of outside surface Lead 4.0 ppm Cadmium 0.4 ppm ASTM C927 “Lip and Rim Test’ “Voluntary” .. FDA Enforced


FDA Standards: FDA Standards U.S. Food and Drug Administration Investigating plates from China sold at major retailer for food contact surface Pb release failure. Investigating several potential lip/rim violations from China & Morocco.


Massachusetts Standard: Massachusetts Standard Pb Restriction Food Contact & Outside Surfaces Total Immersion Test Modified C738 2 ppm. Maximium Allowable Pb release


California Proposition 65: California Proposition 65 State Voter Initiative 1986 Safe Drinking Water and Toxic Enforcement Act Mandates Consumer Warnings for Exposure to hundreds of Chemicals


California Proposition 65: California Proposition 65 Burden on Defendant to show no human exposure above maximum daily limits. No Victim or Alleged Victim Required No Product Defect Alleged. Business Liability Insurance No Victim. No Defect. No Coverage.


California Proposition 65: California Proposition 65 “Bounty Hunters” Potato Chips/French Fries/Keys/Light Bulbs/Apartments/Hotels/Etc.. Proposition 65 Notices of Violation http://proposition65.doj.ca.gov/default.asp


California Proposition 65: California Proposition 65 Legal Challenges California Chamber of Commerce, etc.. Legislative Environment 2/3 Senate and Assembly Vote Required to amend a Voter Proposition Minor Procedural Changes in 2004 Certificate of Merit. Low Hurdle.


California Proposition 65: California Proposition 65 November 1991 California Attorney General Suit Alleged Exposure Food Contact Surfaces of Tableware.


California Proposition 65: California Proposition 65 State Settlement 1993 MAXIMUM Pb LEACHING VALUES Food Contact Surfaces ASTM C738. Lead Release Type of Ware Lead Flatware 0.226 ppm Small Holloware 0.100 ppm Large Holloware 0.100 ppm Cups, Mugs, Pitchers 0.100 ppm


California Proposition 65: California Proposition 65 Attorney General Letter 1998 MAXIMUM Cd LEACHING VALUES Food Contact Surfaces ASTM C738. Cadmium Release Type of Ware Cadmium Flatware 3.164 ppm Small Holloware 0.322 ppm Large Holloware 0.084 ppm


California Proposition 65: California Proposition 65 2002 Allegations Lead & Hand-painted Drinking Glasses Settlement NIOSH 9100 Wipe Test: 1 microgram/wipe safe harbor. Company Reformulates.


California Proposition 65: California Proposition 65 2002 Allegations Major Retailers/ Manufacturers/Importers SGCD Sought AG Intervention Review of Exposure Science


California Proposition 65: California Proposition 65 JC Penney decision August 31, 2004 Settlement Each Settlement Binds Only Parties to Agreement


California Proposition 65: California Proposition 65 Various Settlements Many Variations on August 31, 2004 Cadmium Restrictions beyond Lip/Rim AG Urged to Intervene. Uniform Standard Needed.


California Proposition 65: California Proposition 65 August 18, 2005 Settlement Glass & Ceramicware, Food Use Decorating Materials < 0.06% Pb by weight Decorating Materials < 0.48% Cd by weight OR NIOSH 9100 Wipe Test 1 microgram/wipe Pb 8 Micrograms/wipe Cd


California Proposition 65: California Proposition 65 August 18, 2005 Settlement Glass & Ceramicware, Food Use Lip & Rim Decorating Materials < 0.02% Pb by weight < 0.08% Cd by weight


California Proposition 65: California Proposition 65 August 18, 2005 Settlement Glass & Ceramicware, Children’s Ware Children’s Ware Requirements All Exterior Decorations < 0.06% Pb by weight All Exterior Decorations < 0.48% Cd by weight


California Proposition 65: California Proposition 65 August 18, 2005 Settlement Ceramicware, Food Use (Mugs) Total Acetic Acid Immersion Test Corrected for internal volume 0.99 ppm for Pb 7.92 ppm for Cd


California Proposition 65: California Proposition 65 August 18, 2005 Settlement Ceramicware, Food Use (Mugs) ASTM C927 Lip & Rim Test 0.5 ppm Pb 4.0 ppm Cd


California Proposition 65: California Proposition 65 August 18, 2005 Settlement Glass & Ceramicware, Non-Food Use Figurines Decorative Tiles Ornaments


California Proposition 65: California Proposition 65 August 18, 2005 Settlement Glass & Ceramicware, Non-Food Use Decorating Materials < 0.06% Pb by weight Decorating Materials < 0.48% Cd by weight OR NIOSH 9100 Wipe Test 4 micrograms/wipe Pb 32 Micrograms/wipe Cd


California Proposition 65: California Proposition 65 August 18, 2005 Settlement Warnings Specified On Product or Package At Retail Display In Catalog or on Website Sales Point


California Proposition 65: California Proposition 65 August 18, 2005 Settlement WARNING: The materials used as colored decorations on the exterior of this product contain lead and/or cadmium, chemicals known to the State of California to cause birth defects or other reproductive harm


California Proposition 65: California Proposition 65


California Proposition 65: California Proposition 65 August 18, 2005 Settlement 80% “Reformulated” by Dec. 31, 2006 or other deadline. “All Commercially Reasonable” Efforts to Reach 100% “Reformulated” Thereafter.


California Proposition 65: California Proposition 65 August 18, 2005 Settlement Opt-In Provisions Legally Binding only on Parties to Settlement. Consult with Legal Counsel


California Proposition 65: California Proposition 65 August 18, 2005 Settlement AG Comments New payment category added. Sellers of less than 500 items/year in CA.


California Proposition 65: California Proposition 65 August 18, 2005 Settlement 205 Defendants Opt-in to Boelter $9 million in settlement revenues $5 million plaintiff’s attorneys $1 million Morrison Foerster


California Proposition 65: California Proposition 65 County District Attorney Settlements County DA Interventions. Marin, Santa Cruz, San Luis Obispo and Solano counties. Generally small local companies.


California Proposition 65: California Proposition 65 County District Attorney Settlements Warning Threshold similar to Boelter Substantially Less Costly Right to Warn Preserved


California Proposition 65: California Proposition 65 J.C. Penney Final Settlement Various Appeals denied $2 million final settlement for attorneys fees and costs Longest trial in Proposition 65 history


California Proposition 65: California Proposition 65 New Allegations Continue Retailers Amusement Parks, Casinos, Wineries Promotional Product Distributors Hotels Etc…


California Proposition 65: California Proposition 65 California Distribution Mail Order Catalogs Out-of-State Websites Tiny “Mom and Pop” Retailers


California Proposition 65: California Proposition 65 State/County Attorney Allegations Refillable Soda Bottles Illegally imported from Mexico


California Proposition 65: California Proposition 65 State/County Attorney Allegations PepsiCo Settlement Eliminate Pb and Cd over time from existing refillable stock in Mexico. Substantial Financial penalties.


California Proposition 65: California Proposition 65 Proposition 65 Awareness Check all ware sold in CA for compliance with existing settlements. Use test labs familiar with G/C Prop. 65 settlements. Understand Liability.


California Proposition 65: California Proposition 65 Options Meet “Safe Harbor Standards” of settlements to establish defense. Warn.


Federal Preemption: Federal Preemption Tri-Union Tuna Decision Federal preemption. Court decision for plaintiff against AG Lockyer. Hg in fish. FDA labeling standards preempt Prop. 65 warnings.


House/Senate Lead Alerts: House/Senate Lead Alerts Waxman/Obama Lead Actions House/Senate Gift Shop notices “Unsafe” Lead in souvenir pendants and souvenir pins Mugs not listed.


Toxics in Packaging Clearinghouse: Toxics in Packaging Clearinghouse TPCH Model Legislation No Intentional Addition of Pb/Cd/Cr(6)/Hg to Packaging 19 States enacted legislation (CONEG)


Toxics in Packaging Clearinghouse: Toxics in Packaging Clearinghouse TPCH Model Legislation Glass Exemption (Pb, Cd, Cr(6)) TCLP Test using ASTM C-1606-04 to prepare sample. 1.0 ppm Cd/5.0 ppm Cd/5.0 Cr(6) Exemption on books in CA, IL, MO


Toxics in Packaging Clearinghouse: Toxics in Packaging Clearinghouse TPCH Testing Program Niton XRF Gun 400 Package Samples including some glass containers.


Toxics in Packaging Clearinghouse: Toxics in Packaging Clearinghouse TPCH Testing Program 7 Glass Bottles Questioned Cr(3) present, not Cr(6) TCLP test results provided. Recycled Content exemption.


Toxics in Packaging Clearinghouse: Toxics in Packaging Clearinghouse TPCH Testing Program TPCH to conduct 2nd Round of Tests. Focus on Plastics. Some Glass. 2010 recycling exemption expires.


California Legislation : California Legislation California SB 774 Would eliminate TCLP exemption for Pb for glass bottles. Focus on Mexican soda bottles 0.06% Pb by weight standard


California Legislation : California Legislation California SB 774 TPCH favors uniform state legislation TPCH does not take position on legislation in states


EPA Toxic Release Inventory: EPA Toxic Release Inventory EPA TRI Program Pb reported at 100 lbs. annual threshold since 2001. Burden Relief rule issued December 2006


EPA Toxic Release Inventory: EPA Toxic Release Inventory Form A for Pb reporters No on-site or off-site release Less than 500 lbs. Pb used annually


EPA Toxic Release Inventory: EPA Toxic Release Inventory Form A for Pb reporters EPW Hearing, Klinefelter Testimony House/Senate Democrats introduce bills to eliminate burden reduction H.R. 1055 S. 595


EPA Toxic Release Inventory: EPA Toxic Release Inventory EPA Finalizes Metal Hazards Report PBT Criteria Does not Apply EPA intends to use for future metals rules throughout agency