Docstoc

Legislative Issues CerMA 2007 Proposition 65 Regulatory Update FDA Standards MAXIMUM

Document Sample
Legislative Issues CerMA 2007 Proposition 65 Regulatory Update FDA Standards MAXIMUM Powered By Docstoc
					CerMA 2007

  Proposition 65 &
  Regulatory Update
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
 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
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
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

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


  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


  “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

    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


  November 1991
  California Attorney General Suit
  Alleged Exposure
        Food Contact Surfaces of Tableware.
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

       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

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


  2002 Allegations
  MajorRetailers/
   Manufacturers/Importers
  SGCD Sought AG Intervention
  Review of Exposure Science
California Proposition 65


  JC  Penney decision
  August 31, 2004 Settlement
  Each Settlement Binds Only Parties
   to Agreement
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

     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

     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

     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

     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

     August 18, 2005 Settlement

      Ceramicware, Food Use (Mugs)
       ASTM C927 Lip & Rim Test

        0.5 ppm Pb
        4.0 ppm Cd
California Proposition 65

     August 18, 2005 Settlement

      Glass & Ceramicware, Non-Food Use
       Figurines

       Decorative Tiles

       Ornaments
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

     August 18, 2005 Settlement

         Warnings Specified
           On Product or Package
           At Retail Display

           In Catalog or on Website Sales Point
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

     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

     August 18, 2005 Settlement

       Opt-In Provisions
       Legally Binding only on Parties to
        Settlement.
       Consult with Legal Counsel
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

     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

     County District Attorney Settlements

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

     County District Attorney Settlements

         Warning Threshold similar to Boelter

         Substantially Less Costly

         Right to Warn Preserved
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

     New Allegations Continue

         Retailers
         Amusement Parks, Casinos, Wineries

         Promotional Product Distributors

         Hotels

         Etc…
California Proposition 65

     California Distribution

       Mail Order Catalogs
       Out-of-State Websites

       Tiny “Mom and Pop” Retailers
California Proposition 65

     State/County Attorney Allegations

         Refillable Soda Bottles

         Illegally imported from Mexico
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

     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

     Options

         Meet “Safe Harbor Standards” of
          settlements to establish defense.

         Warn.
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

     Waxman/Obama Lead Actions

       House/Senate Gift Shop notices
       “Unsafe” Lead in souvenir pendants and
        souvenir pins
       Mugs not listed.
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


     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


     TPCH Testing Program

         Niton XRF Gun

         400 Package Samples including some
          glass containers.
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


     TPCH Testing Program

       TPCH to conduct 2nd Round of Tests.
       Focus on Plastics. Some Glass.

       2010 recycling exemption expires.
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 SB 774

         TPCH favors uniform state legislation

         TPCH does not take position on
          legislation in states
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

     Form A for Pb reporters

         No on-site or off-site release

         Less than 500 lbs. Pb used annually
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 Finalizes Metal Hazards Report

         PBT Criteria Does not Apply

         EPA intends to use for future metals
          rules throughout agency