Developments in the US Food/Feed
Safety Regulatory Environment –
FSMA
Jim Dyck (Bunge Canada)
COPA Food/Feed Safety Committee Chair
Saskatchewan Biotech Industry Meeting Dec. 7, 2011
Content
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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 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.
Member Plant Locations
2010 Economic Value of the Oilseed
Processing Industry in Canada
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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
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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
350000
300000
200000
150000
100000
50000
Production
Exports to US
N
J
S
M
20 N
10
J
M
J
S
M
20 N
09
J
M
J
S
M
20 N
08
J
M
S
J
M
20 N
07
J
M
J
S
M
20 N
06
J
M
J
S
M
05
J
M
0
20
tonnes
250000
CFIA / BMP Document
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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
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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)
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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
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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)
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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