FSMA - The Rules

James Theuri Ag. Educator

FSMA  Rules  are  now  available  •  Science-­‐based!  

–  Focus  on  iden7fied  routes  of  microbial  contamina7on    –  Excludes  certain  produce  rarely  consumed  raw  –  Excludes  produce  to  be  commercially  processed  (documenta7on  required)  

•  Sec7on  105  of  the  Act  •  Worker  health,  hygiene  &  training  •  Agricultural  water  (for  produc7on  &  post-­‐harvest  uses)  •  Biological  soil  amendments  (compost,  manure)  •  Domes7cated  &  wild  animals  •  Equipment,  tools,  buildings  &  sanita7on  •  Produc7on  of  sprouts*  

•  Read  more:  hQp://www.fda.gov/Food/GuidanceRegula7on/FSMA/ucm334115.htm    

Who should comply?

•  Understand  “Food  Facility  Registra7on  Requirement”  

•  Under  the  Public  Health  Security  and  Bioterrorism  Preparedness  and  Response  Act  of  2002:  –  if  it  does  not  affect  you,  then  you  do  not  have  to  register  

So,  who  has  to  register?  

Broadly  put:  if  you  – manufacture,  process,  pack  or  hold  food  for  consump7on  in  the  US  …  •  then  you  are  a  facility  …  must  register  with  FDA  

•  Must  follow:  •  cGMPs  (current  Good  Manufacturing  Processes)  •  HARPC  (Hazard  Analysis  Risk-­‐Based  Preven7ve  Controls)  

–  Need  Food  Safety  Plan,  Verifica7on  Measures,  etc  

Who  could  be  exempt  from  registra7on?  

•  In  some  cases  …    – medium-­‐size,  small  and  very  small  farms  

•  Businesses  exempted  include  –  stores,  restaurants,  certain  types  of  direct  market  farms,  etc  

•  For  the  PC  Rule:    –  Bioterrorism  Act  was  modified  in  FSMA  

•  to  protect  medium-­‐size  and  family  farms  from  heavy  costs    

the Preventive Controls Rule

BROADLY  PUT:  •  Domes7c  &  foreign  food  facili7es  – should  follow  cGMPs    (current  good  manufacturing  prac7ces)  

•  Establish/implement  – hazard  analysis    –  risk-­‐based  preven7ve  controls  for  human  foods  

•  (HARPC)  

Am  I  a  Farm?  Or  am  I  a  Facility?  

•  Farm:  •  establishment  under  one  ownership  •  in  one  general  loca7on;  not  necessarily  con7guous  •  devoted  to  growing  &  harves7ng  crops,  animals,  or  both  

•  Farms  may  also:  •  pack  or  hold  raw  agricultural  commodi7es  (RACs)  •  dry  or  dehydrate  RACs  and/or  package/label  them  

-­‐  without  further  processing  

A  ‘Primary  Ac7vi7es  Farm’  

Is  an  operaDon      under  one  management      in  one  general  (but  not  necessarily  con7guous)      physical  loca7on      devoted  to  the  growing  of  crops,      the  harves7ng  of  crops,      the  raising  of  animals  (including  seafood),        or  any  combinaDon  of  these  acDviDes.  

A  ‘Secondary  Ac7vi7es  Farm’  Is  an  operaDon  – not  located  on  a  primary  producDon  farm:    

•  devoted  to  harves7ng  (such  as  hulling  or  shelling),  packing,  and/or  holding  of  raw  agricultural  commodi7es  [RACs].    

– However,  this  defini7on  only  applies    if  the  primary  producDon  farm(s)  that  grows,  harvests,  and/or  raises  the  majority  of  the  raw  agricultural  commodi7es  harvested,  packed,  and/or  held  by  the  secondary  ac7vi7es  farm  owns,  or  jointly  owns,  a  majority  interest  in  the  secondary  ac7vi7es  farm.  

Produce  Safety:  Does  this  Rule  Apply  to  Me?  

Most  small  farms  will  likely  not  be  faciliDes  

Example  1:  Secondary  Ac7vity  Farm  4  brothers  farming  cooperaBvely  (farm  and  pack  in  their  farm)    Each  contributes  25%  to  the  enterprise    Each  owns  25%  of  enterprise    Each  lives  20  miles  away  from  farm  

Packing  operaBon  would  be  considered  a  secondary  acBvity          (it  is  not  on  a  primary  producBon  farm)    CollecBvely,  the  brothers  produce  a  majority  (100%)              (and  also  own  100%  of  the  business)  

Therefore:  The  farm  does  not  need  to  register;  PCR  does  not  apply  

Example  2:  Non-­‐Secondary  Ac7vity  Farm  Green  Farm  aggregates  produce  from  various  farms    Has  a  distribuBon  operaBon;  sell  to  insBtuBons    Each  farm  provides  25%  of  produce    None  of  the  farmers  have  an  ownership  interest  in  the  distribuBon    

Therefore:  The  farm  needs  to  register;  PC  Rule  applies  

Aggregator  does  not  saBsfy  the  secondary  farm  definiBon  

Farmer/Distributor  Jones  

Example  3:  Secondary  Ac7vity  Farm  Green  Farm  aggregates  produce  from  various  farms    Has  a  distribuBon  operaBon;  sells  to  insBtuBons    Each  supplying  farm  provides  25%  of  produce,  and    Each  of  the  supplying  farmers  has  a  15%  ownership  interest  in  the  distribuBon    

Therefore:  The  farm  does  not  need  to  register;  PC  Rule  does  not  apply  

Aggregator’s  farm  saBsfies  the  secondary  farm  definiBon  

Example  4:  Non-­‐Secondary  Ac7vity  Farm  Green  Farm  aggregates  produce  from  various  farms    Has  a  distribuBon  operaBon;  sells  to  insBtuBons    The  4  farmers  together  provide  49%  of  produce;          (the  rest  –  51%  -­‐  is  from  farmers  who  have  no  ownership  in  the  aggregaBon)    Each  of  the  4  farmers  sBll  owns  a  15%  interest  in  the  distribuBon  business  

Therefore:  The  farm  does    need  to  register;  PC  Rule  applies          (majority  produce  is  from  farms  that  have  no  ownership)  

Majority  supply  to  Green  Farm  is  by  non-­‐owners;              Farm  does  not  saBsfy  the  secondary  farm  definiBon  

Example  5:  Non-­‐Secondary  Ac7vity  Farm  Green  Farm  aggregates  produce  from  various  farms    Starts  a  distribuBon  operaBon;  sells  to  insBtuBons    The  4  farmer  owners  together  provide  100%  of  produce;        The  4  farmers  each  owns  a  10%  interest  in  the  distribuBon  business  (there  is  majority  supply  of  RAC’s  by  the  ‘minor’  shareholders    (the  4  farmers  –  they  do  have  a  majority  ownership)  

Therefore:  The  farm  does    need  to  register;  PC  Rule  applies          (majority  produce  is  from  farms  that  have  no  ownership)  

Majority  RAC  supply  to  Green  Farm  is  by  non-­‐owners;          Farm  does  not  saBsfy  the  secondary  farm  definiBon  

Agricultural Water & Microbial Water Quality

•  Water  quality  in  some  cases  •  No  detectable  generic  E.  coli  

•  Examples      •  wash  water,  contact  surface  wash  water,  edible  por7on  wash  water,  sprout  irriga7on  water  •  correc7ve  ac7on  needed  if  generic  E.  coli  is  detected  

2nd  Set  of  Numerical  Criteria  for  AW  

Other  waters:  2  sets  of  criteria  for  quality  – Geometric  Mean  (GM)  (an  average  number)  

–  126  or  less  CFUs  of  E.  coli  per  100  ml  of  water  

– Sta7s7cal  Threshold  Value  (STV)    •  reflects  amount  of  variability  in  water  quality    

»  e.g.  aqer  a  rainfall,  or  river  flood,  washing  into  canals,  ponds,  …  –  410  CFUs  or  less  of  E.  coli  per  100  ml  of  water  

– Online  tool  by  FDA,  analyses  data  

Monitoring Untreated Water

•  Agricultural  Surface  Water  (GM  and  STV  figures)  –  Ini7al  2-­‐year  survey:  

•  Minimum  15  samples  collected  close  to  harvest  •  2nd  Year:  5  samples  (total  20  samples)  •  Over  the  course  of  2  to  4  years  –  “microbial  water  quality  profile”  

•  Agricultural  ground  water:    –  ini7al  1-­‐year  survey:  

•  collect  4  samples,  as  near  as  possible  to  harvest  7me  

–  Calculate  GM  and  STV  •  In  subsequent    years,  minimum  of  1  water  sample  

E.  Coli  Levels  in  Irriga7on  Water  

courtesy W. Kline

New  Jersey  Agricultural  Experimental  Sta7on,  Rutgers  University  

Biological Soil Amendments

•  Raw  manure:  •  Risk  assessment  by  FDA:  

–  Interval  between  manure  applica7on  and  produce  harvest    –  Currently:  use  NOP  standard:    

»  90  days  for  non-­‐soil  contact  crops;  120  for  others  

•  Raw  manure  •  Apply  carefully  to  avoid  contamina7on  of  edible  produce  

–  during  and  aqer  applica7on  

•  Stabilized  compost  •  there  are  set  microbial  limits  for  bacteria  •  apply  same  as  raw  manure  

Food Safety - Sprouts •  A  vulnerable  commodity  

–  too  many  outbreaks,  hospitaliza7ons;  a  couple  deaths  (last  18  years)  

•  Properly  disinfect  plan7ng  seed  –  difficult  to  wash  sprouts  

•  Test  spent  irriga7on  water  •  from  each  produc7on  batch  of  sprouts  •  perform  correc7ve  ac7on(s)  if  water  is  contaminated  

•  Test  for  contamina7on    •  by  Listeria  monocytogenes  

Animal Management

•  Domes7c:  – must  allow  “adequate”  7me  between  harvest  and  grazing  

•  Wild:  – Must  not  harvest  visibly  contaminated  produce  

•  FDA  Vs  NRCS:    –  rules  do  not  intend  to  remove  conserva7on  prac7ces  

•  riparian  zones,  wildlife  habitat,  etc  

Worker Training; Health & Hygiene

•  Health  &  Hygiene:  •  Illness  repor7ng  •  Hygienic  prac7ces  •  Providing  hygienic  facili7es  

•  Training  •  Importance  of  health  &  hygiene  

•  All  (incl.  supervisors,  etc)  •  Be  trained;  educated;  experienced  

Equipment,  Tools  &  Buildings  

•  Can  be  sources  of  contamina7on  •  Incl.  greenhouses,  germina7on  chambers,  etc  

•  Required  preventa7ve  measures  incl  –  appropriate  storage  – maintenance  &  cleaning  of  equipment  &  tools  

Rule  exempts  …  •  Produce  that  is  not  raw  agric  commodity  (RAC)  •  Farms  with  a  3-­‐yr-­‐average  income  of  $25K/yr    •  Produce  rarely  consumed  raw:  

•  examples:    –  asparagus,  many  beans,  garden  beets;  collards;  etc  –  food  grains  –  food  for  personal/on-­‐farm  consump7on  

•  Qualified  exemp7on  &  modified  requirements  –  farms  with  less  than  $500K  per  year  for  the  last  3  years;  –  farm’s  sales  to  qualified  end-­‐user  is  more  than  to  other  buyers  

Compliance Dates •  Very  small  businesses  

–  more  than  $25,000  but  no  more  than  $250,000  in  average  income  during  the  previous  3-­‐year  period  :  four  years  

•  Small  businesses  –  more  than  $250,000  but  no  more  than  $500,000  in  average  income  during  the  previous  3-­‐year  period:  three  years  

•  All  other  farms:  two  years  

•  Compliance  dates  vary  for    –  certain  aspects  of  the  water  quality  standards,  and    –  tes7ng  and  recordkeeping  provisions    Allow  an  addi7onal  two  years  beyond  each  of  these  compliance  dates  for  the  rest  of  the  final  rule  

So,  what  next?  •  Become  GAPs-­‐trained  –  Jan.  11:  Online  GAPs  training  by  U  of  IL  Extension  –  See  www.extension.illinois.edu/gkw      

•  If  you  do  not  sa7sfy  exemp7on      status,  register  your  farm  

•  If  not  exempt,  comply  …    •  for  very  small  farms  -­‐  up  to  4  years  

•  View  the  final  Rule  here:  hQp://www.fda.gov/Food/GuidanceRegula7on/FSMA/ucm334115.htm