1	
INTRODUCTION	 BRC FSMA EXPLAINED
FSMA.
NEXT
STEPS
FSMA.
READY
FSMA.
WHAT DO
I NEED
TO DO?
2	
THE FSMA MARKET	 BRC FSMA EXPLAINED
+
US Food Manufacturers
International Food Manufacturers
(Exporting to the US)
US Food Importers
2,000+sites
THE FSMA MARKET
"IN 2014 THE US FOOD
INDUSTRY WAS ESTIMATED
AT $5.27 TRILLION MAKING
THE USA THE LARGEST FOOD
MARKET IN THE WORLD.
What percentage of food is imported into the US?
The FDA estimates that approximately 15 percent of the U.S. food supply is imported,
including 50 percent of fresh fruits, 20 percent of fresh vegetables and 80 percent of seafood.
30,000+
sites
140,000+site
BRC FSMA EXPLAINED 	 INTRODUCTION
	 3
INTRODUCTION
The FSMA Market	2
Introduction to FSMA 	 3
A Word from Mark Proctor CEO	 4
Global Standards International Landscape	 5
FSMA Customer Types	 6
Who Does FSMA Apply to and by When? 	 7
Getting Your Customer Ready for FSMA	 8
Benefits of FSMA	 9
Training		 10
FAQs		 11
The Act was signed into law by President Obama on January 4, 2011. Its primary aim is to ensure the
US food supply is safe by shifting the focus from just responding to all food risks to preventing them.
FSMA focuses more on preventing food safety issues rather than relying on reacting to problems
after they occur.
The law also provides Food and Drug Administration with new enforcement authority designed to achieve
higher rates of compliance with prevention and risk-based food safety standards and to better respond to
and contain problems when they occur. The law also gives FDA important new tools to hold imported
foods to the same standards as domestic foods and directs FDA to build an integrated national food
safety system in partnership with state and local authorities.
WHERE ARE YOU NOW?
It is very important for any food manufacturer, who is either based in the United States, or who exports to
the United States, to understand how the new FSMA regulations will impact their business moving
forward. The purpose of this FSMA brochure is to explain what FSMA is, why it has been introduced and
what you need to do to ensure that your US supply chain is not impacted. This FSMA brochure explains
what FSMA is, why it has been introduced and what you need to do to ensure that your US supply chain is
not impacted. You will find information to help you understand where you are now, and more importantly
what you need to do to get FSMA ready.
HOW CAN YOU GET FSMA READY?
BRC Global Standards have published an Additional Module for any BRC Global Standard for Food Safety
certificated customer to use to get their business FSMA Ready. The Module is FREE to download from the
BRC Global Standards website. In addition, you can also see the necessary steps for any new or existing
BRC Global Standard for Food Safety customer to follow in this brochure to get their business FSMA Ready.
THE FDA FOOD SAFETY
MODERNIZATION ACT IS THE
MOST EXHAUSTIVE REFORM OF
FOOD SAFETY LAWS IN THE US
IN MORE THAN 70 YEARS.
FOOD AND DRUG ADMINISTRATION
4	
A WORD FROM MARK PROCTOR	 BRC FSMA EXPLAINED
A WORD FROM
MARK PROCTOR
The BRC Global Standards were developed to
establish key criteria that enables manufacturers
to satisfy obligations relating to legal
compliance, consumer protection and will help
them protect their brand.
Through its global reach, rigorous auditing
process and utilisation of the best auditors, the
BRC Global Standards are both a benchmark for
suppliers and a beacon of quality and trust.
In fact, international retailers and food service
companies are increasingly looking for BRC
certification when assessing suppliers’ credentials
and capabilities.
At BRC Global Standards, our reputation
depends on the precision and integrity of our
auditing Standards. We are immensely proud of
that reputation and committed to ensuring our
employees and affiliates uphold our high
standards at all times.
Mark Proctor
Chief Executive Officer
BRC Global Standards
540+Canada
2810+
United States
680+South
America
INTERNATIONAL RETAILERS
AND FOOD SERVICE
COMPANIES INCREASINGLY
SEEK BRC GLOBAL STANDARDS
CERTIFICATION
INTERNATIONAL OFFICES
Chicago
London
New Delhi
5
BRC FSMA EXPLAINED 	 GLOBAL STANDARDS INTERNATIONAL LANDSCAPE
BRC GLOBAL STANDARDS
THE INTERNATIONAL LANDSCAPE
GLOBAL STANDARDS INTERNATIONAL GROWTH
8,500
2008
sites
24,000
sites
2016
3920+UK
1650+
Spain
5615+
Rest of Europe
890+
France
2490+
Italy
600+
Germany
3800+
Asia
540+
Oceana
540+
Afica
6	
FSMA CUSTOMER TYPES	 BRC FSMA EXPLAINED
FSMA CUSTOMER TYPES
BRC GLOBAL
STANDARD
FOR FOOD
SAFETY
ISSUE 7+
FSMA READY
MODULE
US FOOD
MANUFACTURING
SITES DOMESTIC
SUPPLY CHAIN ONLY
FOREIGN FOOD
MANUFACTURING
SITES EXPORTING
TO THE US
US FOOD
MANUFACTURING
SITES DOMESTIC 
INTERNATIONAL
SUPPLY CHAIN
7
BRC FSMA EXPLAINED 	 WHO DOES FSMA APPLY TO?
WHERE ARE YOU NOW?
WHO DOES FSMA APPLY TO AND BY WHEN?
Compliance Timeline as of January 1 2016
Businesstype
6 months 	 1 year 	 18 months 	 2 years 	 30 months	 3 years
All other businesses  500 full-time equivalent employees1
All other businesses  500 full-time equivalent employees2
Small business receiving facility1
Small business receiving facility2
All other businesses  500 full-time equivalent employees
Small businesses  500 full-time equivalent employees
Small businesses subject to the Pasturised Milk Ordinance
Very small businesses $1 million per year3
1
Supplier IS subject to the human preventative controls rule or produce safety rule (or 6 months after the supplier is required to comply, whichever is later).
2
Supplier IS NOT subject to the human preventative controls rule or produce safety rule (or 6 months after the supplier is required to comply, whichever is later).
3
Except for records to support its status as a very small business January 1, 2016.
Nothing
FSMA
READY
ISO 9001
2nd
Party
Audit
ISO
22000
BRC
Food 7
BRC Food 7
plus the FSMA
Ready Module
FSMA ready
Module
8	
GETTING YOUR CUSTOMER READY FOR FSMA	 BRC FSMA EXPLAINED
	 8
BRC GLOBAL STANDARDS HAVE CREATED A
COMPREHENSIVE SUPPORT PACKAGE TO GET
YOU STARTED ON YOUR FSMA JOURNEY
Getting FSMA ready for BRC Global Standard
for Food Safety Issue 7 certificated sites
Contact your
certification body
to add the FSMA
Ready Module to
your next BRC
Food Safety audit
Go to the BRC
Global Standards
website and book
a place on a
FSPCA training
course, to satisfy
the requirements
of FSMA regarding
a competently
trained resource at
your site
www.brctraining
academy.com
Book a ‘gap
analysis’ with your
certification body
to better
understand where
your current gaps
are against the
requirements of
the FSMA Ready
Module
2
1
3
4
Download a free
copy of the FSMA
self assessment
tool and BRC FSMA
Ready Module from
the BRC Global
Standards website
www.brcglobal
standards.com
5
Once you have
successfully
completed the audit
process, including
the additional FSMA
Ready Module, you
will then be able to
provide your
customers with
evidence to confirm
that you are now
‘FSMA Ready’
6 MONTHS
9
BRC FSMA EXPLAINED 	 BENEFITS OF FSMA
BENEFITS OF THE
FSMA READY MODULE
3. Delegates who attend a
FSPCA training course
delivered by the BRC Academy
will be recognised as the site's
FSMA qualified individual
1. Once you have successfully completed the
BRC FSMA Module you will be recognised and
listed as FSMA Ready on the BRC Global
Standards Directory allowing new customers
to locate you
2. Manufacturing sites certificated
to the BRC Global Standard for
Food Safety Issue 7 only need to
comply with the 23 additional
clauses to be FSMA Ready
4. When you have successfully completed the
BRC FSMA Module you will be sent your
FSMA Ready certificate
5. The BRC FSMA Ready
Module has been designed to
be included with your next
BRC Food Safety audit
6. Achieving the BRC FSMA
Ready Module will help you
to continue trading with your
US customers
FSMA READY
10	
TRAINING	 BRC FSMA EXPLAINED
FSMA TRAINING
This training course has been designed
by the Food Safety Preventative
Controls Alliance (FSPCA) in
collaboration with the FDA. It is taught
by a Lead Instructor for the FSPCA
Preventative Controls for Human Food
Course. This course covers the
Preventive Controls for Human Food
Rule that is part of the Food Safety
Modernization Act (FSMA). It also meets
the Preventive Controls Qualified
Individual Training requirements.
• Get certificated as a
Preventive Control
Qualified Individual
by FSPCA
• Learn how to develop a
HARPC food safety plan
• Be prepared for the
new FSMA regulations
• Receive an official FSPCA
course book and Certificate
of Completion
• Learn best practices and
review case study examples
11
BRC FSMA EXPLAINED 	 FAQs
FSMA QAs
WHO CAN TAKE THE FSMA READY MODULE?
Any new or existing BRC Food Safety certificated
customers, this includes brand new food safety clients and
transfers from other food safety standards.
HOW OFTEN SHOULD THE FSMA
MODULE BE COMPLETED?
Once a year, as with the BRC Food Safety audit.
WHAT WILL I RECEIVE AT THE END
OF THE AUDIT?
Once you have satisfied the requirements of the BRC Food
Safety Standard, you will receive an accredited certificate
from your certification body. You will also have a report
from your certification body covering the additional
clauses of the FSMA Module, and once all non-
conformities have been closed out, you will then be able to
provide evidence to your customers that you are ‘FSMA
Ready’. Your certification body also has the option to
provide you with an unaccredited FSMA Ready certificate.
WHAT IF I AM CERTIFICATED TO ANOTHER
FOOD SAFETY STANDARD?
The FSMA Ready Module is exclusively available through
BRC Global Standards, so for the client to benefit from this
assessment, all they have to do is contact you to either
add BRC Food Safety or transfer their food safety
certification to BRC Global Standards.
WHAT IF I HAVE ALREADY HAD MY
FOOD SAFETY AUDIT?
You can contact your certification body, or BRC Global
Standards, to arrange an optional gap analysis of your
current Food Safety Management System against the
requirements of the BRC Food Safety Standard and FSMA
Module. You will then have a much clearer understanding of
any gaps in your existing Food Safety Management System.
HOW MUCH WILL THE FSMA READY
MODULE COST?
Global Standards advise that the FSMA Ready module will
require a minimum of half a day extra to the existing BRC
Food Safety audit duration. The actual cost for this extra
time will need to be confirmed by the client's chosen
certification body.
IS THE FSMA READY MODULE APPROVED
BY THE FDA?
No, the FSMA Ready module has been developed by BRC
Global Standards, through extensive research of the FSMA
requirements. BRC Global Standards believe that the
current BRC Food Safety Standard will take a client to
approximately 95% of FSMA requirements, with the
additional FSMA Ready module taking the site to 100%
FSMA ready.
WHERE CAN I FIND ADDITIONAL INFORMATION
ON BRC GLOBAL STANDARDS AND THE
FSMA MODULE?
FDA website::
www.fda.gov/Food/GuidanceRegulation/FSMA/
BRC Global Standards website:
www.brcglobalstandards.com/Manufacturers/FSMA
Technical Queries
John Kukoly
john.kukoly@brcglobalstandards.com
Sales  Marketing Queries
Neil Coole
neil.coole@brcglobalstandards.com
BRC Global Standards
4th Floor, 2 London Bridge, London SE1 9RA
T. +44 (0)20 7854 8900 F. +44 (0)20 7854 8901 E. enquiries@brcglobalstandards.com
www.brcglobalstandards.com
www.brcparticipate.com
www.brcbookshop.com
Chicago • London • New Delhi

Brc gs-fmsa-brochure

  • 1.
    1 INTRODUCTION BRC FSMAEXPLAINED FSMA. NEXT STEPS FSMA. READY FSMA. WHAT DO I NEED TO DO?
  • 2.
    2 THE FSMA MARKET BRC FSMA EXPLAINED + US Food Manufacturers International Food Manufacturers (Exporting to the US) US Food Importers 2,000+sites THE FSMA MARKET "IN 2014 THE US FOOD INDUSTRY WAS ESTIMATED AT $5.27 TRILLION MAKING THE USA THE LARGEST FOOD MARKET IN THE WORLD. What percentage of food is imported into the US? The FDA estimates that approximately 15 percent of the U.S. food supply is imported, including 50 percent of fresh fruits, 20 percent of fresh vegetables and 80 percent of seafood. 30,000+ sites 140,000+site
  • 3.
    BRC FSMA EXPLAINED INTRODUCTION 3 INTRODUCTION The FSMA Market 2 Introduction to FSMA 3 A Word from Mark Proctor CEO 4 Global Standards International Landscape 5 FSMA Customer Types 6 Who Does FSMA Apply to and by When? 7 Getting Your Customer Ready for FSMA 8 Benefits of FSMA 9 Training 10 FAQs 11 The Act was signed into law by President Obama on January 4, 2011. Its primary aim is to ensure the US food supply is safe by shifting the focus from just responding to all food risks to preventing them. FSMA focuses more on preventing food safety issues rather than relying on reacting to problems after they occur. The law also provides Food and Drug Administration with new enforcement authority designed to achieve higher rates of compliance with prevention and risk-based food safety standards and to better respond to and contain problems when they occur. The law also gives FDA important new tools to hold imported foods to the same standards as domestic foods and directs FDA to build an integrated national food safety system in partnership with state and local authorities. WHERE ARE YOU NOW? It is very important for any food manufacturer, who is either based in the United States, or who exports to the United States, to understand how the new FSMA regulations will impact their business moving forward. The purpose of this FSMA brochure is to explain what FSMA is, why it has been introduced and what you need to do to ensure that your US supply chain is not impacted. This FSMA brochure explains what FSMA is, why it has been introduced and what you need to do to ensure that your US supply chain is not impacted. You will find information to help you understand where you are now, and more importantly what you need to do to get FSMA ready. HOW CAN YOU GET FSMA READY? BRC Global Standards have published an Additional Module for any BRC Global Standard for Food Safety certificated customer to use to get their business FSMA Ready. The Module is FREE to download from the BRC Global Standards website. In addition, you can also see the necessary steps for any new or existing BRC Global Standard for Food Safety customer to follow in this brochure to get their business FSMA Ready. THE FDA FOOD SAFETY MODERNIZATION ACT IS THE MOST EXHAUSTIVE REFORM OF FOOD SAFETY LAWS IN THE US IN MORE THAN 70 YEARS. FOOD AND DRUG ADMINISTRATION
  • 4.
    4 A WORD FROMMARK PROCTOR BRC FSMA EXPLAINED A WORD FROM MARK PROCTOR The BRC Global Standards were developed to establish key criteria that enables manufacturers to satisfy obligations relating to legal compliance, consumer protection and will help them protect their brand. Through its global reach, rigorous auditing process and utilisation of the best auditors, the BRC Global Standards are both a benchmark for suppliers and a beacon of quality and trust. In fact, international retailers and food service companies are increasingly looking for BRC certification when assessing suppliers’ credentials and capabilities. At BRC Global Standards, our reputation depends on the precision and integrity of our auditing Standards. We are immensely proud of that reputation and committed to ensuring our employees and affiliates uphold our high standards at all times. Mark Proctor Chief Executive Officer BRC Global Standards 540+Canada 2810+ United States 680+South America INTERNATIONAL RETAILERS AND FOOD SERVICE COMPANIES INCREASINGLY SEEK BRC GLOBAL STANDARDS CERTIFICATION INTERNATIONAL OFFICES Chicago London New Delhi
  • 5.
    5 BRC FSMA EXPLAINED GLOBAL STANDARDS INTERNATIONAL LANDSCAPE BRC GLOBAL STANDARDS THE INTERNATIONAL LANDSCAPE GLOBAL STANDARDS INTERNATIONAL GROWTH 8,500 2008 sites 24,000 sites 2016 3920+UK 1650+ Spain 5615+ Rest of Europe 890+ France 2490+ Italy 600+ Germany 3800+ Asia 540+ Oceana 540+ Afica
  • 6.
    6 FSMA CUSTOMER TYPES BRC FSMA EXPLAINED FSMA CUSTOMER TYPES BRC GLOBAL STANDARD FOR FOOD SAFETY ISSUE 7+ FSMA READY MODULE US FOOD MANUFACTURING SITES DOMESTIC SUPPLY CHAIN ONLY FOREIGN FOOD MANUFACTURING SITES EXPORTING TO THE US US FOOD MANUFACTURING SITES DOMESTIC INTERNATIONAL SUPPLY CHAIN
  • 7.
    7 BRC FSMA EXPLAINED WHO DOES FSMA APPLY TO? WHERE ARE YOU NOW? WHO DOES FSMA APPLY TO AND BY WHEN? Compliance Timeline as of January 1 2016 Businesstype 6 months 1 year 18 months 2 years 30 months 3 years All other businesses 500 full-time equivalent employees1 All other businesses 500 full-time equivalent employees2 Small business receiving facility1 Small business receiving facility2 All other businesses 500 full-time equivalent employees Small businesses 500 full-time equivalent employees Small businesses subject to the Pasturised Milk Ordinance Very small businesses $1 million per year3 1 Supplier IS subject to the human preventative controls rule or produce safety rule (or 6 months after the supplier is required to comply, whichever is later). 2 Supplier IS NOT subject to the human preventative controls rule or produce safety rule (or 6 months after the supplier is required to comply, whichever is later). 3 Except for records to support its status as a very small business January 1, 2016. Nothing FSMA READY ISO 9001 2nd Party Audit ISO 22000 BRC Food 7 BRC Food 7 plus the FSMA Ready Module FSMA ready Module
  • 8.
    8 GETTING YOUR CUSTOMERREADY FOR FSMA BRC FSMA EXPLAINED 8 BRC GLOBAL STANDARDS HAVE CREATED A COMPREHENSIVE SUPPORT PACKAGE TO GET YOU STARTED ON YOUR FSMA JOURNEY Getting FSMA ready for BRC Global Standard for Food Safety Issue 7 certificated sites Contact your certification body to add the FSMA Ready Module to your next BRC Food Safety audit Go to the BRC Global Standards website and book a place on a FSPCA training course, to satisfy the requirements of FSMA regarding a competently trained resource at your site www.brctraining academy.com Book a ‘gap analysis’ with your certification body to better understand where your current gaps are against the requirements of the FSMA Ready Module 2 1 3 4 Download a free copy of the FSMA self assessment tool and BRC FSMA Ready Module from the BRC Global Standards website www.brcglobal standards.com 5 Once you have successfully completed the audit process, including the additional FSMA Ready Module, you will then be able to provide your customers with evidence to confirm that you are now ‘FSMA Ready’ 6 MONTHS
  • 9.
    9 BRC FSMA EXPLAINED BENEFITS OF FSMA BENEFITS OF THE FSMA READY MODULE 3. Delegates who attend a FSPCA training course delivered by the BRC Academy will be recognised as the site's FSMA qualified individual 1. Once you have successfully completed the BRC FSMA Module you will be recognised and listed as FSMA Ready on the BRC Global Standards Directory allowing new customers to locate you 2. Manufacturing sites certificated to the BRC Global Standard for Food Safety Issue 7 only need to comply with the 23 additional clauses to be FSMA Ready 4. When you have successfully completed the BRC FSMA Module you will be sent your FSMA Ready certificate 5. The BRC FSMA Ready Module has been designed to be included with your next BRC Food Safety audit 6. Achieving the BRC FSMA Ready Module will help you to continue trading with your US customers FSMA READY
  • 10.
    10 TRAINING BRC FSMAEXPLAINED FSMA TRAINING This training course has been designed by the Food Safety Preventative Controls Alliance (FSPCA) in collaboration with the FDA. It is taught by a Lead Instructor for the FSPCA Preventative Controls for Human Food Course. This course covers the Preventive Controls for Human Food Rule that is part of the Food Safety Modernization Act (FSMA). It also meets the Preventive Controls Qualified Individual Training requirements. • Get certificated as a Preventive Control Qualified Individual by FSPCA • Learn how to develop a HARPC food safety plan • Be prepared for the new FSMA regulations • Receive an official FSPCA course book and Certificate of Completion • Learn best practices and review case study examples
  • 11.
    11 BRC FSMA EXPLAINED FAQs FSMA QAs WHO CAN TAKE THE FSMA READY MODULE? Any new or existing BRC Food Safety certificated customers, this includes brand new food safety clients and transfers from other food safety standards. HOW OFTEN SHOULD THE FSMA MODULE BE COMPLETED? Once a year, as with the BRC Food Safety audit. WHAT WILL I RECEIVE AT THE END OF THE AUDIT? Once you have satisfied the requirements of the BRC Food Safety Standard, you will receive an accredited certificate from your certification body. You will also have a report from your certification body covering the additional clauses of the FSMA Module, and once all non- conformities have been closed out, you will then be able to provide evidence to your customers that you are ‘FSMA Ready’. Your certification body also has the option to provide you with an unaccredited FSMA Ready certificate. WHAT IF I AM CERTIFICATED TO ANOTHER FOOD SAFETY STANDARD? The FSMA Ready Module is exclusively available through BRC Global Standards, so for the client to benefit from this assessment, all they have to do is contact you to either add BRC Food Safety or transfer their food safety certification to BRC Global Standards. WHAT IF I HAVE ALREADY HAD MY FOOD SAFETY AUDIT? You can contact your certification body, or BRC Global Standards, to arrange an optional gap analysis of your current Food Safety Management System against the requirements of the BRC Food Safety Standard and FSMA Module. You will then have a much clearer understanding of any gaps in your existing Food Safety Management System. HOW MUCH WILL THE FSMA READY MODULE COST? Global Standards advise that the FSMA Ready module will require a minimum of half a day extra to the existing BRC Food Safety audit duration. The actual cost for this extra time will need to be confirmed by the client's chosen certification body. IS THE FSMA READY MODULE APPROVED BY THE FDA? No, the FSMA Ready module has been developed by BRC Global Standards, through extensive research of the FSMA requirements. BRC Global Standards believe that the current BRC Food Safety Standard will take a client to approximately 95% of FSMA requirements, with the additional FSMA Ready module taking the site to 100% FSMA ready. WHERE CAN I FIND ADDITIONAL INFORMATION ON BRC GLOBAL STANDARDS AND THE FSMA MODULE? FDA website:: www.fda.gov/Food/GuidanceRegulation/FSMA/ BRC Global Standards website: www.brcglobalstandards.com/Manufacturers/FSMA Technical Queries John Kukoly john.kukoly@brcglobalstandards.com Sales Marketing Queries Neil Coole neil.coole@brcglobalstandards.com
  • 12.
    BRC Global Standards 4thFloor, 2 London Bridge, London SE1 9RA T. +44 (0)20 7854 8900 F. +44 (0)20 7854 8901 E. enquiries@brcglobalstandards.com www.brcglobalstandards.com www.brcparticipate.com www.brcbookshop.com Chicago • London • New Delhi