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 -

https://www.google.com/search?q=Globe&tbm=isch&tbs=rimg:C

bjZdq5f_1_1T0IjgKSaF_1z7EQy2z9BGjXl_1i-

2m0MFNffByrX3CiYToA9C7QtjINiYGOBKLJzGMAc8u12ZudDiTuOyioS

CQpJoX_1PsRDLEVAzWIrgPXSfKhIJbP0EaNeX-

L4REIJkXGu5ga8qEgnabQwU198HKhHdA7zxbtUI6SoSCdfcKJhOgD0

LEev68XsEvKXgKhIJtC2Mg2JgY4ERUYmVxHb0hYAqEgkosnMYwBzy7

RF5uSMoXpe-

ZyoSCXZm50OJO47KEdytYXHVFS3I&tbo=u&sa=X&ved=0ahUKEwjos

K_MisPWAhUK4SYKHa5PBykQ9C8IHA&biw=1239&bih=557&dpr=1.55

#imgrc=ozizGQ_Hd0tprM:&spf=1506436858308

US map -

https://www.google.com/search?q=united+states+map+free&rlz=1

T4VRHB_enUS717US719&tbm=isch&tbo=u&source=univ&sa=X&ved=

0ahUKEwiGusL7isPWAhXDZCYKHcnMDA0Q7AkIMg&biw=1239&bih=

557#imgrc=6WeZmOVJAQqVvM:&spf=1506436956691

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 -

https://www.google.com/search?q=procedures+manual+photo&rlz=1T4VRHB_enUS717US719&tbm=is

ch&imgil=_Xy28yHgM9hYtM%253A%253BaLF7sdTtO7X9WM%253Bhttp%25253A%25252F%25252Fsmallbu

siness.chron.com%25252Fguidelines-writing-procedure-manuals-

3121.html&source=iu&pf=m&fir=_Xy28yHgM9hYtM%253A%252CaLF7sdTtO7X9WM%252C_&usg=__xS60

kzaI2i2IUZTmlcdeXgvHZFo%3D&biw=1239&bih=557&ved=0ahUKEwipnsec98LWAhXCYiYKHYw1BkgQyjcI

SQ&ei=pVLKWem3DsLFmQGM65jABA#imgrc=_Xy28yHgM9hYtM:&spf=1506431666103

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

ysis+example&rlz=1T4VRHB_enUS717US719&tbm=isch&i

mgil=32QQoewDigSowM%253A%253BJqnY_ACrkyds2M

%253Bhttps%25253A%25252F%25252Fwww.sampletempl

ates.com%25252Fbusiness-templates%25252Fcertificate-

of-analysis-

template.html&source=iu&pf=m&fir=32QQoewDigSow

M%253A%252CJqnY_ACrkyds2M%252C_&usg=__Hd8_Vh

NB1Fxs0jzLifathYKPy2Y%3D&biw=1239&bih=557&ved=0a

hUKEwjylNKsksPWAhVJfiYKHZMeBOYQyjcINQ&ei=Fm_KW

fKxLMn8mQGTvZCwDg#imgrc=32QQoewDigSowM:&spf

=1506438937724

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

-orP_lcPWAhUIwiYKHUC5AWgQ7AkINg&biw=1239&bih=557#imgrc=xc5z9258C4TSwM:&spf=1506440062172

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

https://www.google.com/search?q=adult+class+free+photo&tbm=isch&tbs=rimg:CfKetqV8YymkIjhb1L0FSrl9H4lsDWaQB0fGTXhu5hslhnMs3pBhAUWApWZQYMU3bm5bMES7B2rq9R5iqQTB

wB0ArioSCVvUvQVKuX0fEZpD6NAFkg6yKhIJiWwNZpAHR8YRFmOlAeWlPhUqEglNeG7mGyWGcxGjigeEyvZ-

OyoSCSzekGEBRYClESV0CtbH0izfKhIJZlBgxTdublsRdYgrXoVRmpUqEgkwRLsHaur1HhFu9EOb2GFbhioSCWKpBMHAHQCuEd3NVdp1S_1f_1&tbo=u&sa=X&ved=0ahUKEwikns2dqcPWAhWJ5y

YKHZHDAeAQ9C8IHA&biw=1239&bih=557&dpr=1.55#imgrc=TXhu5hslhnO_yM:&spf=1506445097356

What is your first

question!

Robin Amsbary

R. Amsbary Consulting, LLCRamsbary@earthlink.net