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  • Chapter  10

    FOOD  ALLERGEN  PREVENTIVE   CONTROLS  FOR  HUMAN  FOOD

  • Food  Allergen  Preventive  Controls  Objectives   (cont’d)  (Slide  10-­‐1  a)

    • Include  only  allergen  preventive  controls  that  are   identified  in  the  hazard  analysis  requiring  a   preventive  control

    • If  different  food  allergens  are  handled  at  the  same   time § Allergen  cross-­‐contact  may  be  the  prevention

    • If  food  allergens  are  in  a  product § Allergen  labeling  may  be  the  prevention

    10-­‐1Instructor’s  Notes

  • When  is  an  Allergen  Control  a  Preventive  Control?   (Slide  10-­‐2  a)

    • Some  facilities  use  icons  to  identify  ingredients   containing  food  allergens.  This  can  usually  be   managed  as  a  GMP  rather  than  a  preventive   control.  Focus  resources  on  what  matters   most.

    • The  term  “sanitation”  may  include  both   cleaning  and  sanitizing  activities.   § Cleaning  is  necessary  to  control  allergens. § Sanitizing  is  intended  to  kill  microorganisms.  Sanitizing   has  little  or  no  impact  on  allergens.

    10-­‐2Instructor’s  Notes

  • Tree  Nuts  [Section  201 (qq)] – may  be  revised (Slide  10-­‐3  a)

    CommonCOMMON/USUAL  NAME (used  for  declaration  of  specific  type  of  nut)  

    Almond   Chestnut  (Chinese,   American,   European,  Seguin)  

    Hickory  nut   Pili nut  

    Beech  nut   Chinquapin   Lichee  nut   Pistachio  

    Brazil  nut   Coconut   Macadamia  nut/   Bush  nut  

    Sheanut

    Butternut   Filbert/hazelnut   Pecan   Walnut  (English,   Persian,  Black,   Japanese,   California),   Heartnut,  Butternut  

    Cashew   Ginko nut   Pine  nut/Pinon nut  

    10-­‐3

    Source:   http://www.fda.gov/ForIndustry/FDABasicsforIndustry/ucm238807.htm (accessed  November  17,  2017)  

  • Other  Countries  (Slide  10-­‐3  b)  

    • Canada   http://www.inspection.gc.ca/food/information-­‐for-­‐ consumers/fact-­‐sheets/food-­‐ allergies/eng/1332442914456/1332442980290 accessed  November  17,  2017

    ALLERGEN ALLERGEN Eggs Soy Milk Wheat Peanuts Mustard Tree  nuts Sesame Seafood  (Fish,  crustaceans,   shellfish)

    Sulphites (>10  ppm):  not  a  true   allergen

    10-­‐3

  • Other  Countries  (cont’d)  (Slide  10—3  c) • Europe http://www.eufic.org/article/en/expid/EUFIC_Review_ on_Food_Allergens/ accessed  November  18,  2017

    ALLERGEN ALLERGEN Eggs Molluscn shellfish

    Milk  and  products Cereals  containing  gluten

    Peanuts Mustard

    Nuts  (almonds,  hazelnut,  walnut,   cashew,  pecan,  brazil  nut,   pistachio,  macadamia,  Queensland   nuts)

    Sulphur dioxide  and  sulphites (>10   ppm):  not  a  true  allergen

    Fish Sesame  seeds

    Crustacean Celery

    Soybeans Lupin

    10-­‐3

  • Other  Countries  (cont’d)  (Slide  10-­‐3  d) • Others

    Country ALLERGEN Australia Molluscan  shellfish Japan Buckwheat Others Barley,  rye

    10-­‐3

  • Allergen  Preventive  Controls  Requirements  (cont’d)   (Slide  10-­‐4  a)

    • For  accurate  allergen  labeling  of  finished  food,  also   be  aware  of § Formulation  mistakes § Ingredient  substitution § Supplier  producing  several  allergen  containing  ingredients § Undeclared  allergens  as  a  major  cause  of  food  recalls.

    • Need  supply-­‐chain  program  for  a  supplier  that   produces  several  allergen  containing  ingredients,   such  as  nuts.

    10-­‐4Instructor’s  Notes

  • June  20,  2017 JFC  International  Inc.  issues  missing  English  label  resulting  in  no  allergy   alert  because  of  undeclared  wheat,  soybean,  and  fish  (Bonito)  in  Futaba   Sesame  Hijiki Rice  Seasoning. No  illnesses  have  been  reported.  

    Source:  http://www.fda.gov/Safety/Recalls/

  • June  20,  2017 United  Natural  Foods,  Inc.  (UNFI)  issues  a  recall  of  a  single  production   batch  of  Fat  Cat  Purry-­‐Purry Sauce  Hot  Sauce  because  an  ingredient   supplier,  Woodland  Foods  of  Chicago,  IL,  notified  Fat  Cat  Gourmet  Foods   that  there  was  a  possible  peanut  contamination  in  the  peri-­‐peri peppers   used.   No  illnesses  have  been  reported.  

    Source:  https://www.fda.gov/Safety/Recalls/ucm563889.htm (accessed  July  3,  2017)

  • Allergen  Cross-­‐contact  Prevention  Considerations  (cont’d)   (Slide  10-­‐5  a)

    Prevent  cross-­‐contact  by: • Not  processing  different  food  allergens  at  the  same  time  or  at  

    all • Not  having  conflicting  schedules  with  other  operations • Managing  allergens  as  a  prerequisite  program  or  a  preventive  

    control • Keeping  track  of  allergens  from  receiving  to  finished  product • Training  employees  to  make  them  understand  the  seriousness  

    of  allergens

    How  the  facility  manages  their  system  and  the  complexity  of   their  allergen  concerns  will  determine  if  above  are  PC  or   prerequisite  program.  All  of  the  above  must  be  documented.

    10-­‐5

  • Equipment  Cleaning  (cont’d)  (Slide  10-­‐6  a) A  Potential  Preventive  Control  for  Allergens

    • In  the  absence  of  established  allergen  thresholds,   thorough  cleaning  means  no  visible  residue  at  a   minimum  (visually  clean).

    • Validation  of  allergen  cleaning  procedures  may  be   useful, desirable,  or strongly  encouraged: § If  cleaning  procedures  need  to  be  adjusted § The  first  time  a  unique  allergen  is  introduced  for  a  complex   equipment  on  a  production  line

    § When  major  changes  are  made  to  product  formulation.

    10-­‐6Instructor’s  Notes

  • Equipment  Cleaning (cont’d)  (Slide  10-­‐6  b) A  Potential  Preventive  Control  for  Allergens

    • Validation  results  are  recorded  in  Sanitation  Record   or  Allergen  Scheduling  Record

    • Validation  helps  to  protect  your  business  and  the   consumer’s  health

    • Ways  alternative  to  equipment  cleaning   § Color-­‐coding  or  labeling  equipment—see  handouts  in  my   website

    § Using  physical  barrier  (walls,  curtains,  partitions)  between   production  lines  in  close  proximity

    § Training  of  staff

    10-­‐6Instructor’s  Notes

  • Verification  of  Allergen  Cleaning  (cont’d)   (Slide  10-­‐7  a)

    • No  need  to  validate  visually  clean if  met • During  changeovers,  “Push  Through”  material  may  be  

    used  to  establish  safe  times  and  volumes • Adenosine  triphosphate  (ATP)  tests  and  protein  swabs  

    may  not  detect  low  levels  of  allergens  that  cause   allergenic  reactions  but  indicate  effectiveness  or  extent  of   cleaning.  ATP  is  the  molecule  that  most  cells  use  as  their   main  energy.

    • Enzyme-­‐linked  ImmunoSorbant Assays  (ELISA)  and   Polymerase  Chain  Reaction  (PCR)  are  more  sensitive  and   can  detect  food  allergens  at  the  molecular  level  levels.  

    • Testing  of  all  allergens  is  now  possible.

    10-­‐7Instructor’s  Notes

  • Examples  of  Test  Kits  (not  an  endorsement)   (Slide  10-­‐7  b)

    • Neogen:  Almond,  β-­‐Lactoglobulin (BLG),  casein,   cashew,  crustacean,  egg,  gliadin/glute

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