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Safety of Imported Foods An Industry Perspective October 29, 2009

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Title: Safety of Imported Foods An Industry Perspective October 29, 2009


1
Safety of Imported Foods- An Industry
Perspective October 29, 2009
  • Craig W. Henry Ph.D.
  • Senior Vice President and Chief Operating
    Officer, Scientific and Regulatory Affairs
  • Grocery Manufacturers Association
  • Washington, D.C.

2
Key Topics
  • Consumer Confidence
  • US Food Imports
  • Industry Stewardship
  • Modernizing the US Food Safety System
  • Summary and Next Steps

3
Consumer Confidence
4
Consumer Confidence
  • Recent events have exposed weaknesses in our food
    safety net and shaken consumer confidence in the
    safety and security of the food supply both
    domestically produced and imported
  • Spinach Peanut Butter Pet Food

5
Consumer Confidence in Food Safety is Down
  • The number of consumers "completely" or "somewhat
    confident" in the safety of supermarket food
    declined
  • 82 percent in 2006
  • 66 percent in 2007

FMI Consumer Trends 2007, January 2007 survey
6
Consumer Confidence in Food Safety is Down
  • 38 percent of consumers stopped purchasing
    certain foods in the past 12 months (vs 9 in
    2006)
  • spinach (71 percent),
  • lettuce (16 percent),
  • bagged salad (9 percent) and
  • beef (8 percent).

FMI Consumer Trends 2007, January 2007 survey
7
Consumer Confidence
  • Recalls have a huge financial impact
  • Peanut Butter (Salmonella) 66 million
  • Spinach (E.coli) 25-50 million
  • Pet Food (melamine) 40 million
  • Chili Sauce (botulism) 35 million
  • Topps Meat (E.coli) 31 million
  • Tomatoes/Peppers (Salmonella)200 million

8
FDA Salmonella Saintpaul Outbreak
  • Since April,1401 persons infected with Salmonella
    Saint Paul with the same genetic fingerprint have
    been identified in 43 states, the District of
    Columbia, and Canada.
  • Since the salmonella outbreak began in April,
    1,423 people have fallen ill and the produce
    industry has lost more than 200 million as
    consumers have shied away from buying fresh
    produce.

9
Irradiation Petition to FDA
10
Irradiation Petition Ready-to-eat Foods
  • Developed by the Food IrradiationCoalition led
    by GMA
  • 30 Trade, Academic Industry
  • Initially, Broad Scope for GenericApproval of
    Many R-T-E Foods
  • No Changes in Labeling Proposed

11
Recent Strategy for Gaining Approval
  • Narrow the Scope FDA has Difficulty with
    Generic Approvals
  • Target Foods With Demonstrated Opportunity
    Hot Dogs, Luncheon Meats Fresh Produce
  • Follow Dose Level Ranges Already Approved for
    Meat Poultry

12
Petition Scope
13
Ready-to-eat Foods Petition Status
  • Filed with FDA, October 1999
  • On August 21st, FDA approved irradiaton control
    of food-borne pathogens and extension of shelf
    life in fresh iceberg lettuce and fresh spinach,
    not to exceed a dose of 4.0 kGy.
  • This was a partial response to a petition filed
    by The National Food Processors Association on
    behalf of The Food Irradiation Coalition

14
Food Imports and Consumer Confidence
15
Expectations for Assuring Food Safety in the
Global Food Economy
16
Globalization of the food supply means that we
(all countries) must share responsibility for
food safety throughout the entire food supply
chain from producers to consumers.
17
The World on your Plate
Herb Butter
Chicken Breast
- Ireland, Belgium UK, France etc.
Flour Water
Batter
Bread Crumbs
Chicken Kiev
10 countries!
Courtesy A. Reilly, FSAI, Ireland
18
A Multinational Loaf Amy Schoenfeld New York
Times, June 15, 2007
  • INGREDIENTS
  • Wheat gluten
  • Honey
  • Calcium proprionate
  • Guar gum
  • Flour enrichments
  • Beta-carotene
  • Vitamin D3

19
A Multinational Loaf Amy Schoenfeld New York
Times, June 15, 2007
  • Wheat gluten France, Poland, Russia,
    Netherlands, Australia
  • Honey China, Vietnam, Brazil, Uruguay, India,
    Canada, Mexico, Argentina
  • Calcium proprionate Netherlands
  • Guar gum India
  • Flour enrichments China
  • Beta-carotene Switzerland
  • Vitamin D3 China

20
Global Food Trade
Already 40 of all trade in agriculture,
fisheries forestry occurs between developing
developed countries. More than 20 of all US
imports are food products (more than 8 million
shipments a year).
21
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22
US Essential Oils and Spice Imports
23
Changes and Challenges Global Food Supply

16.3 MILLION IMPORT LINES

9.1 MILLION FOOD LINES

Estimated
24
Supply Chain Management
25
Supply Chain Management
  • What is Supply Chain Management?

Due diligence to assure that products received
from suppliers meet required regulatory, legal,
and contractual standards of safety.
26
Supply Chain Management
  • Food industry relies upon a web of inter-company
    relationships
  • Producers and growers
  • Brokers
  • Repackers
  • Ingredient vendors
  • Co-Manufacturers

27
Supply Chain Management
  • Food industry relies upon a web of inter-company
    relationships
  • Successful interactions are precursors to
    effective food safety management
  • Knowing and building relationships represents
    sound investments

28
Importance of Supply Chain Management
29
Importance of Supply Chain Management
  • Role in Food Safety
  • Legal Considerations
  • Regulatory compliance
  • Liability

30
Importance of Supply Chain Management
  • Role in Food Safety
  • Legal Considerations
  • Financial Considerations
  • Price vs Quality
  • Cheaper ? less expensive!
  • Value of Brand
  • Commercial brand
  • Reputation of exporting economy

31
Importance of Supply Chain Management
  • Role in Food Safety
  • Consumer
  • EXPECT and ASSUME food to be safe
  • Put responsibility and blame on both product AND
    exporting economy

32
Importance of Supply Chain Management
  • Role in Trade
  • Domestic
  • Facilitate efficient and effective movement of
    product
  • Assure compliance with all national and/or local
    laws and regulations

33
Importance of Supply Chain Management
  • Role in Food Safety
  • Role in Trade
  • Domestic
  • International
  • Facilitate efficient and effective movement of
    product
  • Assure compliance with all national and/or local
    laws and regulations of BOTH exporting and
    importing economies

34
Importance of Supply Chain Management
  • Role in Trade
  • Domestic
  • International
  • Facilitate efficient and effective movement of
    product
  • Assure compliance with all national and/or local
    laws and regulations of BOTH exporting and
    importing economies
  • Conformance with International Agreements (WTO,
    CODEX, etc.)
  • Bolster consumer confidence in importing economy

35
Factors to Consider in Supply Chain Management
  • Regulatory Requirements
  • Working knowledge of laws and regulations of
    importing economy
  • Technical/scientific basis for regulatory
    requirements
  • Risk assessment
  • Official methods of analysis
  • Customer Requirements
  • Expectations of Suppliers
  • Product specifications

36
Industry Stewardship Suppliers Best Practices
37
SOURCING PRODUCTS IN A GLOBAL MARKETFood
Supplier Best Practices
  • October 2-3, 2007, Washington, DC
  • 150 attendees
  • Importers
  • Manufacturers
  • Retailers
  • US and foreign regulators
  • Trade officials

38
  • GMA Food Supply Chain Handbook

http//www.gmabrands.com/publications/GMA_SupplyCh
ain2.pdf
Electronically available at no charge
in, English, Spanish, French, Russian and
Mandarin Chinese
39
Table of Contents
  • INTRODUCTION
  • SCOPE
  • DEFINITIONS
  • ACRONYMS
  • SUPPLIER MANAGEMENT
  • SUPPLIER PRE-ASSESSMENT AND REVIEW
  • Food safety and sanitation
  • Preventative procedures
  • Other

40
Table of Contents
  • REGULATORY COMPLIANCE
  • FOOD DEFENSE
  • Foundation programs for a comprehensive food
    defense program
  • SANITATION PROGRAMS
  • FOOD SAFETY
  • EMPLOYEE TRAINING
  • ENVIRONMENTAL MONITORING
  • ALLERGEN CONTROL
  • FOREIGN MATERIAL CONTROL

41
Table of Contents
  • LABEL CONTROL PROGRAMS AND CONSUMER PACKAGING
  • Design Controls
  • Inventory Controls
  • Labels controls for ingredient and industrial
    packaging
  • PRODUCT AND INGREDIENT TRACING
  • PRODUCT TESTING
  • CONTROL OF NON-CONFORMING PRODUCT (HOLD AND
    RELEASE)

42
Table of Contents
  • CONSUMER COMPLAINTS
  • RECALLS AND MARKET WITHDRAWALS
  • Recalls or market withdrawals can be necessary
    for a variety of reasons
  • CRISIS MANAGEMENT (OTHER THAN RECALLS AND MARKET
    WITHDRAWALS)
  • Successful components of a comprehensive crisis
    management program
  • OTHER PREVENTIVE CONTROL PROGRAMS
  • RESOURCES / REFERENCES

43
Achieving a Successful Supply Chain Management
System
44
Achieving a Successful Supply Chain Management
System
  • Infrastructure
  • Regulatory infrastructure
  • Capacity of regulatory system
  • Capability of regulatory system

45
Achieving a Successful Supply Chain Management
System
  • Infrastructure
  • Regulatory infrastructure
  • Private Sector
  • Scientific foundation
  • Technological capability
  • Processes for assuring compliance throughout the
    supply chain

46
Achieving a Successful Supply Chain Management
System
  • Infrastructure
  • Ongoing Training and Education
  • Recent incidents involving food safety highlight
    the challenges in building regulator and
    manufacturer technical competence and
    understanding of food safety management.
  • Use of international best practices in food
    safety management to better assure the safety of
    the food supply chain
  • International, inter-sector food safety training
    outreach

47
Modernizing the Food Safety System GMA Members
Approach
48
GMA Foundational Elements for an Effective Food
Safety System
  • Adequate funding
  • Adequate authority
  • Adequate effective training
  • Risk-based
  • Industry responsibility
  • Leveraged resources
  • Research

49
Proposed Import Control Program by GMA4 Pillars
50
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51
Pillar One Mandatory Foreign Supplier Quality
Assurance Program
  • New mandatory requirement.
  • All importers of record must establish programs
    to ensure imported foods meet FDA safety and
    quality requirements.
  • GMPs, HACCP, audits, testing,
  • Food companies would utilize FDA guidance to
    adopt foreign supplier food safety programs and
    practices.

52
Pillar Two Voluntary Qualified Importer Food
Safety Program
  • Prioritize imports to focus FDA inspections,
    resources, and relieve congestion at ports.
  • Permit importers who meet high safety standards
    and who voluntarily share additional testing and
    data to be eligible for expedited entry.

53
Pillar Three Build Capability of Foreign
Governments
  • Expand capacity of foreign governments to prevent
    and detect threats to food safety.
  • Expand FDA training and science outreach
    overseas.
  • Expand FDA access to foreign facilities and data.
  • Expand the adoption and harmonization of
    international food safety standards.

54
Pillar Four Expand Capacity of FDA
  • Dramatically expand FDA resources, including
    personnel, laboratory capacity, and scientific
    expertise.
  • Increase and target inspections.
  • Improve FDAs analytical testing and use of
    information technology.

55
Modernizing the Food Safety System White House
Approach
56
Federal Import Food Safety Interagency Working
Group Report to the White House
  • Focus on Prevention
  • Advance a common vision interagency
  • Increase Accountability
  • Focus on Risks over the Life Cycle
  • Build Interoperable Systems (ITDS)
  • Collaboration
  • Technological Innovation Science

57
Interagency Working GroupRecommendations
  • 50 Specific Actions - Examples
  • Mandatory recall authority - risk of an adverse
    outcome and lack of company cooperation 
  • Good Importer Practices FDA authority for
    preventative controls (HACCP)
  • Accreditation for third party inspectors.
  • Best Practices for Track and Trace
  • FDA registrations 2 year renewal
  • Re-inspection fees
  • Verification through certification
  • Enhanced records access in food emergencies
  • Enhanced Penalties
  • Enhanced funding for FDA
  • Address Port Shopping

58
Modernizing the Food Safety System Regulatory
Approach
59
FDA Food Protection Plan
  • Prevention
  • Corporate responsibility, risk assessment and
    mitigation measures
  • Intervention
  • Risk based inspection, sampling and surveillance
  • Response
  • Immediate response and improve risk communication
    to stakeholders

60
FDA Takes Next Step in Establishing Overseas
Presence
  • FDA's plans to hire and place FDA staff in China
    over the next 18 months
  • FDA will be hiring a total of five local Chinese
    nationals to work with the new FDA staff at the
    U.S. Embassy in Beijing and the U.S. Consulates
    General in Shanghai and Guangzhou

http//www.fda.gov/bbs/topics/NEWS/2008/NEW01806.h
tml
61
FDA Beyond our Borders
  • China
  • MOA signed December 2007
  • Establish an office in 2008 ( 9 FTEs)
  • India
  • Establish an office (11 FTEs)
  • South/Central America
  • Development of an MOU
  • Establish a pressence (7 FTEs)
  • Europe
  • Presence planned (3 FTEs)
  • Middle East
  • Presence planned (3 FTEs)

62
Guidance for IndustryVoluntary Third-Party
Certification Programs for Foods and Feeds
  • FDA issued draft guidance in the Federal Register
    notice and requesting comment
  • This is commensurate with GMAs Pillar One
    request for a guidance document

63
Modernizing the Food Safety System Legislative
Approach
64
Key Legislative Proposals
  • House
  • Dingell - H.R. 3610, Food and Drug Import Safety
    Act of 2007
  • Pallone - H.R. 3624, Consumer Food Safety Act of
    2007
  • DeGette - H.R. 3485, Tracing and Recalling
    Agricultural Contamination Everywhere (TRACE) Act
    of 2007
  • DeGette H.R. 3484, Safe and Fair Enforcement
    and Recall for Meat, Poultry, and Food Act of
    2007
  • Dingell, Pallone, Stupak - Food and Drug
    Administration Globalization Act of 2008
    Discussion Draft
  • Costa, Putnam - The Safe Food Enforcement,
    Assessment, Standards and Targeting Act (Safe
    FEAST Act) of 2008
  • Senate
  • Durbin - S. 1776, Imported Food Security Act of
    2007
  • Durbin - S. 654 Safe Food Act of 2007
  • Durbin, Burr - FDA Food Safety Modernization Act
    2008
  • The more balanced approach for FDA

65
FDA Food Safety Modernization Act S. 3385
  • GMA Supports
  • Requiring food companies to identify potential
    hazards in the production and processing of foods
    and to adopt preventive controls to address those
    hazards. This provision reflects food safety
    practices that our members utilize in their
    manufacturing facilities and that all food
    companies should implement.
  • Providing FDA express authority over fresh
    produce and the companion provision for a pilot
    project to improve its traceability.
  • Directing that FDAs inspection system be
    risk-based and that FDAs resources be targeted
    where the risk to the public health is greatest.

66
FDA Food Safety Modernization Act S. 3385
  • GMA Supports
  • Strengthening import controls, including the
    foreign supplier verification program, the
    voluntary qualified importer program, and
    building the capacity of foreign governments.
  • Mandatory recall authority where a company
    refuses to do so voluntarily and the risk to
    consumers is very serious.

67
FDA Food Safety Modernization Act S. 3385
  • GMA Concerns
  • Section 102 -- Suspension of Registration.
  • This is an extraordinary authority which FDA
    already has the authority to accomplish by
    seeking a court injunction, and the intervention
    of a Federal judge is needed to ensure fairness.
  • Section 103 Civil Penalty for Failure to Comply
    with a Mandatory Recall Order.
  • There is no value added and refusal would already
    subject the company to criminal liability,
    financial losses as a result of the recall would
    likely exceed greatly any such penalty.

68
FDA Food Safety Modernization Act S. 3385
  • GMA Concerns
  • Sections 104, 106 and 109 Intentional
    Contamination.
  • Stay focused on food safety issues, and not seek
    to address threats from intentional
    contamination, including acts of terrorism.
  • Section 105 Performance Standards.
  • It is not practical for FDA to conduct, at least
    every 2 years, a comprehensive evaluation of
    epidemiological data and other information to
    identify the most significant hazards.
  • The frequency of such reviews, therefore, should
    be left to the discretion of the FDA.

69
FDA Food Safety Modernization Act S. 3385
  • GMA Concerns
  • Section 108 Administrative Detention.
  • If the scope is to be expanded to include
    misbranded products, that should be limited to
    misbranding under 403(w) which covers undeclared
    allergens.
  • Section 113 Authority to Collect Fees for
    Re-inspections and Product Recalls.
  • GMA opposes the provision for new and
    unprecedented fees tied to re-inspections and
    product recalls.

70
FDA Food Safety Modernization Act S. 3385
  • GMA Concerns
  • Section 201 Mandatory Use of Accredited
    Laboratories.
  • GMA believes that the use of these laboratories
    should be limited to for cause circumstances.
  • Food companies should be free to use any
    laboratory, including company laboratories, to
    conduct routine testing of imports ingredients
    and finished products.
  • Section 308 Accreditation of Private, Third
    Party Auditors.
  • The role of private, third party auditors should
    be voluntary to allow food companies to improve
    their food safety programs and to audit their
    suppliers, but not to be converted into FDA
    surrogates to perform what is fundamentally a
    government function.

71
FDA Food Safety Modernization Act S. 3385
  • GMA Concerns
  • Section 310 Funding for Food Safety.
  • Such funding should provide adequate personnel
    for both the scientific/regulatory functions in
    FDAs Center for Food Safety and Applied
    Nutrition (CFSAN) and the field inspection
    functions in the Office of Regulatory Affairs
    (ORA).
  • The current bill only sets goals for field
    inspectors.
  • Either separate, companion goals for CFSAN should
    be established, or an appropriate ratio of
    Center/field staff should be specified.

72
Modernizing the Food Safety System Global
Initiatives
73
Food Safety Initiatives U.S. Trading Partners
  • Canada
  • Food and Consumer Safety Action Plan, December
    2007
  • Registration Licensing of Importers
  • New compliance and enforcement mechanisms
  • Legislation Bill C-51 (adjourned without
    adoption)
  • Expands inspection powers
  • Establishes licensing for importers
  • Increases penalties
  • Good Importer Practices (GIP) voluntary code of
    practice

74
Food Safety Initiatives U.S. Trading Partners
  • European Union
  • Rapid Alert System for Food and Feed (RASFF)
    integrated approach to information exchange
  • 30 Countries EC
  • 2007 - 42 notifications on products originating
    outside of the EU
  • Project to promote worldwide pilot programs in
    Asian countries

75
Food Safety Initiatives U.S. Trading Partners
  • Australia New Zealand
  • Food Standards Amendments Importer registration
    and database
  • - consultation August 2008
  • Food Control Plan food safety guidance document
    voluntary
  • Ensure Industry takes responsibility for
    providing safe and suitable foods

76
Food Safety Initiatives U.S. Trading Partners
  • Japan
  • More rigorous testing at import 10 of all
    imports
  • Prescreening Chinese exporters
  • Produce specific licensing of exporters from
    China (spinach)

77
Food Safety Initiatives U.S. Trading Partners
  • Food Safety Bills in development restructuring
    of authority, labeling, documentation, tracing
  • Hong Kong
  • China
  • India

78
Food Safety Initiatives Global Standards
  • Codex
  • Guidelines for Foreign On Site Inspections and
    Audits
  • Annex to Code of Hygienic Practice Fresh Fruits
    and Vegetables leafy vegetables
  • Guidelines for National Food Inspection Systems
    Discussion Paper
  • Guidelines on Traceability/Product Tracing
    Discussion Paper

79
Food Safety Initiatives Private Standards
  • WTO Sanitary/Phytosanitary Agreement
  • Article 2 Members shall ensure that their
    sanitary and phytosanitary measures do not
    arbitrarily or unjustifiably discriminate
  • Article 3 Members shall base their sanitary or
    phytosanitary measures on international
    standards, guidelines or recommendations (e.g.
    Codex)

80
Food Safety Initiatives Private Standards
  • WTO Sanitary/Phytosanitary Agreement
  • Article 5 Members shall ensure that their
    sanitary or phytosanitary measures are based on
    risk assessment
  • Article 13 Members shall take such reasonable
    measures as may be available to them to ensure
    that non-governmental entities within their
    territoriescomply with the relevant provisions
    of this Agreement
  • Global Debate -
  • Question What is the responsibility of national
    authorities in private standards?

81
Food Safety Initiatives Private Standards
  • SPS Committee
  • October 2008 Working Group on Private
    Standards - Geneva
  • Issue Private Standards Often Cannot be Met by
    Developing Countries
  • What is a Private Standard?
  • Do Private Standards Developers have
    International Obligations?
  • Are they Discriminatory?
  • Do they require a risk based justification?
  • What are the Responsibilities of National
    Governments?

82
Summary
  • International trade in foods and agricultural
    products will continue to increase
  • Managing the supply chain will be essential to
    assuring safe products and consumer confidence
  • Both government and private sector entities must
    possess adequate infrastructure to properly
    manage supply chain
  • Commitment to training and adoption of new
    technologies will be essential

83
Next Steps
  • October 2008 Working Group on Private
    Standards Geneva - ???
  • Suppliers must take responsibility for what they
    buy and sell in the marketplace.
  • The clout of the commercial process must be
    leveraged immediately to eliminate producers of
    high risk products leading to recalls and reduced
    consumer and Congressional confidence.
  • GMA will continue to promote a science based
    approach to legislative and regulatory
    initiatives that improves consumer confidence.
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