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Developments in the US Food/Feed Safety Regulatory Environment – FSMA

This article discusses the recent developments in the US food/feed safety regulatory environment, particularly the Food Safety Modernization Act (FSMA), and its implications for the Canadian oilseed industry. It also highlights the Canadian oilseed industry's experience with the US regulatory system and import alerts.

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Developments in the US Food/Feed Safety Regulatory Environment – FSMA

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  1. Developments in the US Food/FeedSafety Regulatory Environment –FSMA Jim Dyck (Bunge Canada) COPA Food/Feed Safety Committee Chair Saskatchewan Biotech Industry Meeting Dec. 7, 2011

  2. 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

  3. Canadian Oilseed Processors Association Member 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.

  4. Member Plant Locations

  5. 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

  6. 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

  7. Canadian Canola Meal Production & US Exports

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

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