PROPOSITION  65    –  PVC  Tech  Corp  Compliance  Summary  

 

  1  

www.pvctech.com  ©PVC  TECH  Corp. All  Rights  Reserved.  This  summary  is  non-­‐legally  binding.    It  has  been  published  as  an  overview  of  the  subject  headed  for  purposes  of  summary  review  and  does  not  replace  the  obligation  of  individual  companies  to  identify,  review  and  understand  the  subject  and/or  regulations  discussed  and  its  implications  on  their  organization.  

February  2015  

PROPOSITION  65  of  California    Proposition  65,  otherwise  known  as  the  Safe  Drinking  Water  and  Toxic  Enforcement  Act  of  1986  or  Prop  65  was  a  voter  initiative  passed  into  law  to  address  public  concern  over  exposure  to  unsafe  and  toxic  chemicals  in  the  State  of  California.      Proposition  65  states  the  following:      

§ 25249.5  Prohibition  on  Water  Contamination    “No  person  in  the  course  of  doing  business  shall  knowingly  discharge  or  release  a  chemical  known  to  the  state  to  cause  cancer  or  reproductive  toxicity  into  water  or  onto  or  into  land  where  such  chemical  passes  or  probably  will  pass  into  any  source  of  drinking  water,  notwithstanding  any  other  provision  or  authorization  of  law  except  as  provided  by  Section  25249.9.”    

 § 25249.6  Requirement  of  a  Clear  and  Reasonable  Warning  Prior  to  Exposure  

 “No  person  in  the  course  of  doing  business  shall  knowingly  and  intentionally  expose  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,  except  as  provided  by  Section  25249.10”    

   So  what  does  that  mean?    It  means  two  main  things.      One  is  that  we  have  to  be  sure  that  in  conducting  our  business  no  chemicals  included  in  the  Proposition  65  Chemical  List  are   intentionally   released   to   any   sources   of   drinking   water.       This   extends   to   requesting   our   manufacturers   for  certification  to  assure  that  our  film  content  complies  with  Prop  65.      And   two,   that   we   post   physical   warnings   that   legibly   and   reasonably   forewarn   individuals   within   the   vicinity   of   any  potential  exposure  to  any  restricted  chemicals  on  the  Prop  65  list.          Are  all  PROP  65  listed  chemicals  banned?    And  does  this  mean  I  need  to  test  all  the  substances  on  the  list?        PROP  65  does  not  ban  any   chemicals,   though   this   is   a   common  misperception.     Instead  PROP  65   lists   substances  and  provides  Safe  Harbor  Numbers  where  available.    It  also  changes  as  substances  are  listed  and  de-­‐listed.      PROP  65  relies  on  industry  and  their  know-­‐how  to  identify  the  listed  substances  relevant  to  their  product.    For  instance,  the  PROP  65  list  includes  salted  fish  as  a  substance.    It  would  not  be  likely  for  most  products  to  contain  that.      While  testing  may  be  performed  to  determine  substance  content  and  exposures,   the  regulation   itself  does  not  specify  any  test  methods  nor  does  it  mandate  that  testing  be  performed.      It  is  up  to  companies  in  the  process  of  complying  to  decide  if  testing  would  be  required  to  achieve  the  necessary  information  critical  to  determining  compliance.            

         

 PROPOSITION  65    –  PVC  Tech  Corp  Compliance  Summary  

 

  2  

www.pvctech.com  ©PVC  TECH  Corp. All  Rights  Reserved.  This  summary  is  non-­‐legally  binding.    It  has  been  published  as  an  overview  of  the  subject  headed  for  purposes  of  summary  review  and  does  not  replace  the  obligation  of  individual  companies  to  identify,  review  and  understand  the  subject  and/or  regulations  discussed  and  its  implications  on  their  organization.  

February  2015  

What  are  Safe  Harbor  Numbers?      The   NSRL   (No   Significant   Risk   Level)   for   carcinogens   and   MADL   (Maximum   Allowable   Dose   Levels)   for   reproductive  toxicants  are  called  Safe  Harbor  Numbers.    These  numbers  express  in  µg  per  day  what  the  assigned  No  Risk  or  Allowable  Dosage  exposure  levels  are  for  each  chemical.      The   Safe   Harbor   Number   was   designed   to   be   a   trigger.     If   the   Safe   Harbor   Number   is   exceeded   then   a   warning   or  disclosure  is  automatically  required.    It  is  the  OEHHA’s  goal  to  have  the  entire  Chemical  List  designated  with  safe  harbor  numbers  but  the  process  takes  time.      As  of  early  2015,  only  310  of  the  900  plus  substances  on  the  PROP  65  list  had  Safe  Harbor  Numbers  assigned  to  them.        PROPOSITION  65  List  of  Chemicals                                    Note:    access  via  http://oehha.ca.gov/prop65/prop65_list/Newlist.html      So   if   the   chemicals   I   find   in  my  product  DON’T  have  a   Safe  Harbor  Number,   then   I   don’t   need   to  post  warnings  or  disclose  this  information?      The   absence   of   an   assigned   Safe   Harbor   number   does   not   change   the   requirement   to   disclose,   especially   as   the  chemicals   on   PROP   65   have   been   specifically   listed   for   their   propensity   to   cause   cancer   or   reproductive   toxicity   if  leached.      The  prohibition  on  water  contamination  (Part  25429.5)  relies  on  what  chemicals  are  “knowingly”  discharged  or  released  in  the  course  of  doing  business.        In  fact,  guidance  on  Proposition  65  states  that  “If  there  is  no  safe  harbor  level  for  a  chemical,  businesses  that  knowingly  expose   individuals   to   that   chemical   would   generally   be   required   to   provide   a   Proposition   65   warning,   unless   the  business  could  show  that  the  risks  of  cancer  or  reproductive  harm  resulting  from  the  exposure  would  be  below  levels  specified  in  Proposition  65  and  its  accompanying  regulations.”      

Prop  65  Chemical  List  January  2015  Over  950+    

Substances/Items   310    approximate  number  of  

substances  with    Safe  Harbor  Numbers  

         

 PROPOSITION  65    –  PVC  Tech  Corp  Compliance  Summary  

 

  3  

www.pvctech.com  ©PVC  TECH  Corp. All  Rights  Reserved.  This  summary  is  non-­‐legally  binding.    It  has  been  published  as  an  overview  of  the  subject  headed  for  purposes  of  summary  review  and  does  not  replace  the  obligation  of  individual  companies  to  identify,  review  and  understand  the  subject  and/or  regulations  discussed  and  its  implications  on  their  organization.  

February  2015  

I  noticed  some  really  hazardous  chemicals   like  DEHP  don’t  have  a  safe  harbor  number  (exposure  limit)  but  I’ve  seen  that  labs  will  test  this  to  a  content  limit  I  don’t  find  on  the  PROP  65  list,  where  does  that  content  limit  come  from?      In  the  absence  of  a  safe  harbor  number  or  exposure  level,  or  where  the  exposure  level  is  not  reasonable  or  applicable  for  the  product  or  item  being  reviewed,  the  certain  substances  then  default  to  referencing  an  “interim”  content  limit  derived  from  the  most  recent  judgment  on  products  of  similar  use.      If  another  more  recent  judgment  presents  a  more  stringent  limit  applicable  to  the  same  category  of  product  that  would  then  be  used.    Here’s  a  theoretical  example:    

• You  have  a  PVC  binder  made  with  a  combination  of  flexible  materials  and  you  want  to  have  it  tested  for  DEHP.    • But  you’re  not  sure  what  limit  to  meet  and  test  to.    • The  last  California  court  case  judgment  on  a  PVC  soft  folder  similar  to  your  product  was  found  to  be  in  violation  

of  PROP  65  for  lack  of  a  warning  and  was  then  settled  with  a  requirement  for  that  manufacturer  to  reformulate  the  product  to  contain  less  than  1000  ppm  total  content  of  DEHP.  

• Since  DEHP  does  not  have  a   safe  harbor  number,  by  default,   laboratories  will  use   the  most   related   judgment    (the  case  above)  to  derive  the  interim  limit.    

 This  is  what  is  called  a  confluence  between  exposure  limits  and  content  limits.    This  occurs  due  to  gaps  in  substance  limit  information,  the  inevitable  variances  in  end  use  product  exposure  testing  and  as  part  of  the  process  of  how  PROP  65  is  enforced.        While   it’s   widely   recognized   that   this   is   less   than   ideal,   it   has   become   the   norm   in   industries   to  monitor   frequently  litigated  PROP  65  listed  substances  that  may  be  found  in  their  products  in  order  to  prevent  being  subject  to  enforcement  actions.          Exposure  Limits  vs.  Content  Limits  under  PROP  65.      It’s   important  to  note  that  Safe  harbor  numbers  are  exposure  levels,  which  require  determination  based  on  use.  Many  component  materials  cannot  be  measured  for  end  use  exposures  since  components  represent  only  one  part  of  the  final  product.       While   PROP   65   also   requires   warnings   in   California   workplaces   and   domiciled   companies   can   ascertain  exposures   of   dangerous   chemicals   to   workers   and   their   environment,   most   PROP   65   enforcement   focuses   on   final  products  distributed  through  markets,  or  public  environments  (including  workplaces)  where  substance  exposures  can  be  detrimental.      Where  final  products  are  concerned,  most  supplying  component  manufacturers  have  defaulted  to  controlling  substances  based  on   content   level   even   though   there   are  no   standardized   correlations  between   content   levels   and  exposure.     In  fact,  the  PROP  65  list  makes  no  mention  of  any  content  restrictions.      Final  goods  manufacturers  must  therefore  consider  critical  substance  content  information  as  well  as  the  normal  and  foreseeable  use  of  their  product  in  calculating  exposures.          What  does  being  PROP  65  compliant  actually  mean?    A  company  or  entity  is  compliant  with  PROP  65  either  by  ensuring  their  products  do  not  expose  the  public  to  PROP  65  listed  substances,  OR  failing  that,  by  placing  clear  and  reasonable  warnings  to  notify  the  public  of  those  exposures.      

         

 PROPOSITION  65    –  PVC  Tech  Corp  Compliance  Summary  

 

  4  

www.pvctech.com  ©PVC  TECH  Corp. All  Rights  Reserved.  This  summary  is  non-­‐legally  binding.    It  has  been  published  as  an  overview  of  the  subject  headed  for  purposes  of  summary  review  and  does  not  replace  the  obligation  of  individual  companies  to  identify,  review  and  understand  the  subject  and/or  regulations  discussed  and  its  implications  on  their  organization.  

February  2015  

So  there  are  two  levels  of  compliance,  one  on  the  Substance  Level  and  another  on  the  Labeling  or  Notification  Level.        The  phrase  “PROP  65  compliant”  may  therefore  indicate  that  this  product  does  not  present  exposures  to  substances  or  that  warnings  have  been  placed.    It’s  important  to  know  the  difference  when  speaking  to  your  component  suppliers.          My  business  is  not  based  in  California,  but  my  products  do  find  their  way  there,  do  I  still  need  to  worry  about  PROP  65?      Yes,   you  do.     PROP  65   is   a  California   law   that   imposes   its   requirements  on   any  products   and  processes   that   enter   its  markets  regardless  of  source  or  origin.      Exemptions  to  PROP  65  do  not  relate  to  the  geography  of  the  product  source.      As  a  non-­‐resident  business,  you  would  not  need  to  worry  about  occupational  warnings  required  under  PROP  65.        PROP  65  Warnings    Title   27   Article   6   §   25601   of   the   California   Code   of   Regulations   provides   information   regards   “clear   and   reasonable  warnings”.       This   discusses   warnings   for   certain   categories   of   products   such   as   consumer   products,   food,   alcoholic  beverages,   prescription   drugs,   medical   and/or   dental   procedures   as   well   as   occupational   warnings.       None   of   these  warnings  are  industry  specific.      http://oehha.ca.gov/prop65/law/pdf_zip/RegsArt6.pdf    In  January  2015,  the  OEHHA  (The  Office  of  Environmental  Health  Hazard  Assessment)  formally  proposed  changes  to  how  warnings  are  written,  graphically  depicted  and  placed.    These  proposed  changes  are  pending  approval.   If  adopted  this  would  replace  current  warning  methodologies  and  present  additional  requirements  for  business  and  CA  workplaces.          To  Warn  or  Not  to  Warn:  when  warning  may  negatively  impact  sales  of  your  product    While   PROP   65   issues   two   seemingly   simple   requirements,   the   regulation   often   presents   a   conundrum   for   many  businesses  in  evaluating  how  to  comply  and  how  warnings  would  impact  sales.        For   companies  marketing  products   sensitive   to   negative   perceptions   of   potential   environmental   hazards,   the  decision  not   to   warn   often   leads   back   to   the   drawing   board.     Redesign   and   reformulation   to   improved   safer   products   and  materials  is  in  fact,  one  of  the  goals  behind  the  creation  of  PROP  65.      Enforcement   is   rampant   under   PROP   65   and   avoiding   warnings   is   only   possible   if   products   are   remade   to   where  substance  exposure  requirements  are  satisfied,  or  if  the  same  product  is  not  sold  in  California  at  all.        If   redesign   is   the  most   viable   path   for   you,   identifying   the   substance   composition   of   your   product   will   be   critical   to  successful  compliance.              

         

 PROPOSITION  65    –  PVC  Tech  Corp  Compliance  Summary  

 

  5  

www.pvctech.com  ©PVC  TECH  Corp. All  Rights  Reserved.  This  summary  is  non-­‐legally  binding.    It  has  been  published  as  an  overview  of  the  subject  headed  for  purposes  of  summary  review  and  does  not  replace  the  obligation  of  individual  companies  to  identify,  review  and  understand  the  subject  and/or  regulations  discussed  and  its  implications  on  their  organization.  

February  2015  

PROP  65  and  Other  Chemical  Regulations    Many  of  the  substances  and  chemicals  listed  under  PROP  65  are  also  found  in  other  regulations  such  as  the  US  CPSIA  for  lead  and  phthalates,  the  US  CONEG  for  heavy  metals,  different  chemical  acts  by  state  and  various  European  regulations  such  as  RoHS  for  lead  and  flame  retardants,  and  REACH  for  Substances  of  Very  High  Concern.        PROP  65  is  not  derived  from  any  other  regulation.    While  proposed  chemical  listings  may  use  data  gathered  for  use  in  other  regulations,  a  chemical  can  only  be  successfully  listed  through  one  of  four  mechanisms:      

• Via  the  State  Qualified  Experts  (SQE)  Mechanism  • Via  the  Authoritative  Bodies  (AB)  Mechanism  • Via  the  Formally  Required  Mechanism  • Via  the  Labor  Code  Section  6382  (b)(1)  or  (d)  Mechanism  

 While  trends  in  other  regulations  may  provide  additional  impetus  for  the  OEHHA  to  list  a  substance,  changes  in  the  PROP  65  list  can  only  be  made  through  the  methods  identified  above.      Subsequently,  compliance  to  any  other  regulation  does  not  translate  to  compliance  to  PROP  65,  nor  can  certification  under  other  regulations  be  submitted  for  PROP  65.        PROP  65  lab  testing  may  use  content  testing  methodologies  identified  for  use  under  other  regulations  such  as  the  CPSIA  phthalates  test,  or  REACH  –  but  final  compliance  on  end  use  or  final  products  must  address  the  matrix  of  both  content  and  exposure  levels  specific  to  PROP  65.        PVC  Tech  Corp  and  PROP  65    As  a  California  business  PVC  Tech  Corp  complies  with  the  requirements  of  Prop  65  in  the  workplace  and  in  our  products.      For  substance  compliant  products:    We  develop   films  designed  with  substance  content   restrictions  relevant   to   the  most   recent  PROP  65   list.    We  monitor  changes  to  the  list  that  may  affect  this  substance  compliance  and  advise  our  customers  accordingly.    If  you  are  interested  in  a  film  that  can  help  your  final  product  comply  with  PROP  65,  please  contact  us.        For  substance  non-­‐compliant  products:    Where  we  have  films  that  contain  substances  that  can  present  exposures,  the  appropriate  warnings  are  placed.        We  provide  any  available  certifications  for  compliant  materials  or  disclosures  for  films  non-­‐compliant  due  to  substance  content,  all  of  which  are  traceable  to  our  manufacturers.