Developments in the US Food/Feed

Safety Regulatory Environment –

FSMAJim Dyck (Bunge Canada)COPA Food/Feed Safety Committee

ChairSaskatchewan Biotech Industry Meeting

Dec. 7, 2011

Content

COPA Overview Recent Canadian oilseed industry experience with the

US regulatory system- Import Alert- CFIA and the Best Management Practices document- FDA Guidance Document

Food Safety Modernization Act (FSMA)- Overview- Implications for Canadian oilseed industry

Canadian Oilseed Processors AssociationMember companies: ADM Agri-Industries Company Bunge Canada Cargill Limited LDM Yorkton Corp Richardson Oilseed Limited Viterra Inc.

COPA is a non-profit industry association that promotes the further processing of oilseed products and broadens the scope for domestic and export market opportunities for Canadian oilseed products.

Member Plant Locations

2010 Economic Value of the Oilseed Processing Industry in Canada DIRECT ECONOMIC BENEFITS Farm returns from seed purchases $3,180 million Value-added from crushing $360 million Value-added from refining & processing $330 million Multiplier effect $1,380 million TOTAL $5,250 million

CONTRIBUTION TO CANADIAN BALANCE OF PAYMENTS Import replacement $1,480 million Export earnings $2,930 million TOTAL $4,410 million

Import Alert Canola crushing plants put on US Import Alert

by FDA due to detection of Salmonella in canola meal shipments from Canada (2008 – 2009)

Stopped US exports of canola meal from those plants

Nearly all Canadian crushers affected Took between 9 months and 1+ years to be

removed All plants affected have now been removed from

the Import Alert list

Canadian Canola Meal Production & US Exports

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Production Exports to US

CFIA / BMP Document COPA formed an ad hoc “Salmonella” committee to

address the Import Alert issue Worked with CFIA – developed a “Best Management

Practices” document to be used in discussions with FDA CFIA developed an Inspection Protocol and carried out

pilot inspections at several crushing plants Work with CFIA identified several variances between the

Feeds Regulations and industry practice which are being addressed

Further developments in the US (Guidance Document and FSMA) superseded work on the BMP document

FDA Guidance Document August, 2010 - FDA issued a “Draft Compliance Policy

Guide” for Salmonella in Animal Feed Identified 7 (of 2,400) serotypes of Salmonella, each as

being of concern to certain specific animal groups Originated from the Center for Veterinary Medicine and

is recommended (not binding) to FDA inspectors. Guidance suggests that no action is required if

Salmonella serotypes other than the 7 are found Since the last plant was put on Import Alert (late 2009)

there have been fewer inspections of canola meal shipments for Salmonella

US Food Safety Modernization Act (FSMA)

Signed into law by President Obama in January, 2011 Involves sweeping changes to existing regulations and gives

new and enhanced powers to FDA and USDA FDA has more power to detain suspect foods/feeds, require

recalls and impose charges and fines Requires increased inspections of domestic and foreign

facilities producing food/feed for US consumption Has placed a strong emphasis on traceability of foods/feeds

and ingredients FDA & USDA to prepare a National Agricultural and Food

Defense Strategy Act will rolled out as rules issued over the next few years

FSMA – Implications for Canadian Canola Industry

Inspections – FDA to inspect 600 foreign facilities supplying US this year – to double each year for 5 years

Registration – continue current registration of foreign facilities but must re-register every 2 years

FDA encouraged to approve other domestic and foreign agencies (e.g. CFIA) in carrying out their mandate

Strong emphasis on HACCP as a preventative activity – will look at 3rd party auditing to ensure compliance

Importers to disclose if a food/feed has been refused entry by another country or port of entry

FSMA – Implications for Canadian Canola Industry

(cont’d) User fees for re-inspection Will implement a risk based (meaning HACCP) Foreign

Supplier Verification Program as well as a voluntary Qualified Importer Program

Will have an accrediting program for both 3rd party auditors and 3rd party laboratories