Food Safety Modernization Act Developed by R. Amsbary Consulting, LLC
Food Safety
Modernization ActDeveloped by R. Amsbary Consulting, LLC
An Act is passed by Congress and
signed into law by the President.Photo – National Park Service
Regulations are the responsible
agency’s interpretation of how we
meet the Act.Photo – www.FDA.gov
FSMA was signed into Law on
January 4, 2011.
Photo – cnn.com
Code of Federal
Regulations for the FDA
21 CFR
21 CFR 117 Subpart A
Re-Register!!!Even numbered years
Between
October 1 – December 31
Good Manufacturing
Practices
Graphic – www.alamy.com – COEP60
Good Manufacturing
Practices (GMP’s)
Suspended 21 CFR 110
Now 21 CFR 117 Subpart B
Changed “shall” to “must”
“Should” removed or changed to “must”
Hazard Analysis
Preventive Controls
(HARPC)
21 CFR 117 Subpart C
The following is the roll-out for compliance
General Compliance – One year from final rule
Small Business (less than 500 employees) – Two
years
Very Small Business (Human food annual sales less
than $1 million) – 3 years
Compliance Date
Preventive Controls: Human Food – 8/30/15
Preventive Controls: Animal Food – 8/30/15
Produce Safety – 10/31/15
Accredited Third-Party Certification –10/31/15
Foreign Supplier Verification Program for Importers – 10/31/15
Sanitary Transportation of Food – 3/31/16
Intentional Adulteration / Defense – 5/31/16
Final Rule Issue Date
Foreign Supplier
Importer compliance is 18 months or within 6
months of supplier’s compliance deadline
Small Business Very Small Business
Produce 3 years (+ 60 days) 4 year (+ 60 days)
Defense 2 years (+ 60 days) 3 years (+ 60 days)
Compliance Dates
Preventive Controls for
Human Food
Photo -https://www.google.com/search?q=photo+rice&rlz=1T4VRHB_enUS717US719&tbm=isch&imgil=YSE2LDH1cvUVDM%253A%253BW_OjdlX18cNdsM%253Bhttps%25253A%25252F%25252Fwww.shutterstock.com%25252Fsearch%25252Frice&source=iu&pf=m&fir=YSE2LDH1cvUVDM%253A%252CW_OjdlX18cNdsM%252C_&usg=__GqTu3WEc2P7MipjpuFQL5Z-Tjmo%3D&biw=1239&bih=557&ved=0ahUKEwifwPPWh8PWAhUKQyYKHf7BDmIQyjcIMQ&ei=5mPKWZ-1IoqGmQH-g7uQBg#imgrc=T24Fpv1WGEeu2M:&spf=1506436074125
Preventive Controls
Qualified Individual
(PCQI)
https://www.ifsh.iit.edu/fspca
HACCP
Vs. Food Safety Plan
Global map -
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US map -
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Hazard Analysis Critical
Control Point
(HACCP)
Hazard Analysis of:
- Raw materials
- Process
HACCPList all documented
programs that prevent
the potential hazard from
occurring
HACCPRisk Assessment – considering
preventive program effectiveness
Se
ve
rity
of
Illn
ess
/In
jury High
Evaluate
programsYes Yes
MediumEvaluate
programsYes Yes
Low NoEvaluate
programs
Evaluate
programs
Low Medium High
Likelihood of Occurrence
HACCP - CCPDetermine if there is a
downstream process step
that prevents, reduces, or
eliminates the identified
hazard
Food Safety Plan
21 CFR 117 – Subpart C
Photo -
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Food Safety Plan
Hazard Analysis of:
- Raw materials
- Process
- Finished Product
- Environment
Food Safety PlanHazard Categories- Biological
- Chemical
- Physical- Radiological
- Economic Fraud that
causes harm
Food Safety Plan
Radiological Hazards
- Water
- Raw materials
Graphic source - https://libreshot.com/nuclear-power-plant-between-fields/
Radiological Analysis - Water
On-site
Source
Municipal
source
Economic Fraud that
causes harm
Photo - https://libreshot.com/?s=dog+tombstone
Stay Current With the Regulations!
Rice - Arsenic
The California Office of Environmental Health Hazard
Assessment (OEHHA) is proposing levels of inorganic arsenic
in white and brown rice from all origins, as follows:
White rice – 80 ppb
Brown rice – 170 ppb
Food Safety PlanHazard Analysis – Likelihood
without your preventive programs
Se
ve
rity
of
Illn
ess
/In
jury High Yes Yes Yes
Medium Yes Yes Yes
Low No Yes Yes
Low Medium High
Likelihood of Occurrence
Food Safety PlanMandatory Preventive
Programs
Allergen Cross Contact PreventionUSA-Regulated Allergens
Environmental Monitoring
Ready-to-Eat Products
Left - Listeria - By Elizabeth White - This media comes from the Centers for Disease Control and Prevention's Public Health Image Library (PHIL), with identification number #2287. https://commons.wikimedia.org/w/index.php?curid=717987
Right - Salmonella – https://en.wikipedia.org/wiki/Salmonella#/media/File:SalmonellaNIAID.jpg
Environmental Monitoring
Ready-to-Eat Products
USA Rice Federation position:
Photos: https://pixabay.com/en/sushi-japanese-delicious-asian-373588/
Supplier Verification
- Approved Supplier
Photo – old building - Linseed Oil Mill in Amsterdam, NY - http://www.lostlandmarks.org/kellog.htmlPhoto – new building – vaccine mfg in Korea - http://www.panoramio.com/photo/22837639
Supplier Verification
- Verification
Photo – new building – vaccine mfg in Korea - http://www.panoramio.com/photo/22837639
Recall
- If you identify a potential hazard
that is prevented by your supplier
or by you
Photo – Recall button -
https://www.google.com/search?q=certificate+of+anal
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Food Safety PlanPreventive Processes
Process that
prevents a
hazard from
reaching the
customer/
consumer
ORphoto - https://foodmag.com.au/product/safeline-super-throat-metal-detector-from-mpi-australia/
Process that
warns a
customer/
consumer that
potential
hazard has
not been
controlledLabel -https://www.google.com/search?q=allergen+warning+photo+free&rlz=1T4VRHB_enUS717US719&tbm=isch&tbo=u&source=univ&sa=X&ved=0ahUKEwi
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Process that
warns a
customer/
consumer that
potential
hazard has
not been
controlled
Label - https://www.bakersauthority.com/products/general-mills-gold-medal-stone-ground-
wheat-a-laxa-course-ground-whole-wheat-flour-50-lb-bag
Process that
warns a
customer/
consumer that
potential
hazard has
not been
controlled
Label - https://www.bakersauthority.com/products/general-mills-gold-medal-stone-ground-wheat-a-laxa-course-ground-whole-wheat-flour-50-lb-bag
Take a deep breath
What Now?
Identify your Preventive Controls Qualified
Individual (PCQI)
What Now?
Graphic - http://images.clipartpanda.com/manager-clipart-canstock19630266.jpg
Diverse-knowledge team
Production, Maintenance, Receiving/Storage/Shipping,
Housekeeping/Sanitation, Procurement, Quality, etc
What Now?
Photo – dissolve.com
Have the team review the HACCP Plan(s) and
affiliated programs – Are they complete,
documented, and uniformly implemented?
What Now?
Photo – dissolve.com
Modify the HACCP Plans to reflect the FDA
requirements for Food Safety Plans
What Now?
Photo – https://www.tops-products.com/legal-binder-with-slant-dr-ring-2-14-x-8-1-2-black-4-ring.html
Educate and Train the Employees and the
Qualified Individuals (QI)
What Now?
Graphic
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What is your first
question!
Robin Amsbary
R. Amsbary Consulting, [email protected]