FSMA. TO DO? FSMA. - BRC Global Standards · self assessment tool and BRC FSMA ... to the BRC Global Standard for Food Safety Issue 7 only need to comply with the 23 additional clauses

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

8,5002008

sites24,000

sites

2016

3920+ UK

1650+ Spain

5615+ Rest of Europe

890+ France

2490+ Italy

600+ Germany

3800+ Asia

540+ Oceana

540+ Afica

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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

Bus

ines

s ty

pe

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

1Supplier 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). 2Supplier 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). 3Except 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

5Once 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

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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 Q&As

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 [email protected]

Sales & Marketing Queries Neil Coole [email protected]

BRC Global Standards 4th Floor, 2 London Bridge, London SE1 9RA T. +44 (0)20 7854 8900 F. +44 (0)20 7854 8901 E. [email protected]

www.brcglobalstandards.com www.brcparticipate.com www.brcbookshop.com

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