BIOTECHNOLOGY The Perspective of the U'S' Food Industry February 2004 Karil L' Kochenderfer Grocery

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BIOTECHNOLOGYThe Perspective of the U.S.
Food IndustryFebruary 2004Karil L.
Kochenderfer Grocery Manufs. Of America
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Grocery Manufs. Of America

• Worlds largest association of food, beverage and
  consumer product companies
• Led by Board of Directors of 44 CEOs
• Addresses public policy and business issues
  affecting the industry.
• We are the Familiar Brand Name Products
• on U.S. Grocery Store Shelves

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GMA Member Companies
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Public Acceptance of Biotech Foods

• Risk Paradigm
• 1. Risk Assessment (Scientists)
• 2. Risk Management (Government)
• 3. Risk Communications (Everyone)
• All Three are Critical for Public Acceptance
• of New Technologies like Biotechnology
• (Microwave Ovens, Cell phones, PCs)

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Risk Assessment Biotech Foods

• Consensus that biotech foods are as safe as their
  conventional counterparts
• World Health Organization
• U.N. Food Agriculture Organization
• Org. for Economic Cooperation Development
• National academies of science
• Australia, Canada, India, Mexico, U.K., U.S. .
• 3,000 scientists from throughout the world

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Risk AssessmentBiotech Foods

• Consensus that biotech foods are as safe as their
  conventional counterparts
• National Governments
• Argentina, Canada, So. Africa, United States
• European Commission
• U.S. Scientific Institutions Societies
• National Academy of Science
• American Medical Association
• American Nutrition Association
• Council of Agricultural Science Technology
• Institute of Food Technologists

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Risk Assessment Biotech Foods

• International Council for Science
• (Paris-based Federation of more than 100
  national
• science academies)
• Currrently available GM foods are safe to
  eatThis view is shared by several
  intergovernmental agencies including the FAO/WHO
  Codex Alimentarius Commission on food safety,
  which has 162 member countries, the European
  Commission and the OECDFurther, these is no
  evidence of any ill effects from the consumption
  of foods containing genetically modified
  ingreidents.
• ICS Report (June 2003)

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Risk Assessment Biotech Foods

• British Food Standards Agency
• There is no evidence currently available
  that GM foods have any adverse effect on human
  health.
• Sir John Krebs, Chairman
• French Pasteur Institute 
• Weve never had the least incidence with GMOs
  not a single incident in 25 years of research and
  use. So, if policies are followed, I conclude
  its safe.
• Maurice Hofnung, Director

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Risk Assessment Biotech Foods

• U.S. National Academy of Science
• Crops modified by molecular and cellular
  methods should pose risks no different from those
  modified by classic genetic methods for similar
  traits.
• Academy Report, 1992
•  

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Risk Assessment Biotech Foods

• Dr. Patrick Moore
• Founder Former Intl President, Greenpeace
• The campaign of fear now being waged against
  genetic modification is based largely on fantasy
  and a complete lack of respect for science and
  logic. There are so many real benefits from
  genetic modification compared to the largely
  hypothetical and contrived risks that it would be
  foolish to ban genetic modification.
• Testimony
• New Zealand Royal Commission
• on Genetic Modification

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Risk Management Biotechnology

• International Frameworks
• Codex Alimentarius (Food Safety)
• Biosafety Protocol (Environmental Impacts)
• World Trade Organization (Trade Impacts)
• National Governments
• United States
• USDA/Animal Plant Health Inspection Service
  (APHIS)
• EPA/Office of Pesticides
• FDA/Center for Food Safety Nutrition

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Risk Management Biotech Food Labeling

• FDA Labeling Policy
• Compositional Change
• Nutritional Change
• Health Issue (Allergenicity)
• Mandatory
• Applies to All Foods, including Biotech Foods
• Truthful, Nonmisleading

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Risk Management Biotech Food Labeling

• Recognizes that Consumers Get Information From a
  Variety of Sources
• Preserves the Label for the Most Important
  Information Safety Nutrition Data
• Recognizes Potential to Mislead Consumers,
  Communicate that Biotech Foods are Somehow
  Different
• FDA Draft Guidance for Voluntary Biotech Claims

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Proposed Biotech Food Labels

•  
• GENETICALLY ENGINEERED
•  
• United States Government Notice
• This Product contains Genetically Engineered
  Materials, or was Produced with a Genetically
  Modified Material
•  

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Biotech Foods in Europe

• Technological Change
• Series of Regulatory Mishaps (Mad Cow, HIV-Blood,
  Dioxin Feed)
• Activist Intervention
• Organic Retailer Demands
• No EU Constituency (Farmers Subsidized)
• Cultural affinity to Food
• American Multinationals

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European Model

• Biotech foods viewed as unsafe
• Food companies have reformulated and resourced
  their products
• No products are labeled
• No consumer understanding of biotechnology
• No consumer choice
• Moratorium on ag biotechnology
• Environmental benefits foregone
• Extensive political effort to reform system

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National BiotechLabeling Mandates

• 21 of Top 25 US Agri-food Markets
• Labeling or Considering Labeling
• - 9 Implemented EU (7), Japan, Korea
• - 10 Implementing Philippines, Aus/NZ
• Russia, Singapore, China, Saudi Arabia
• Brazil, Taiwan, Israel
• - 2 Considering Mexico, UAE

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Risk Communications Biotechnology

• No Food Safety Threat
• Biotech foods substantially equivalent to
  conventional foods
• No Need to Label
• FDA labeling policy reserves label for safety and
  nutritional information
• FDA Draft Voluntary Labeling Guidelines
• Provides for consumer choice

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Risk Communications Biotechnology

• Is There a Role for More Information?
• YES!
• Absent readily available information
• about the safety and regulation of
  biotechnology,consumers will doubt
• its safety, demand labeling and reject
  innovation in order to minimize risk

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BiotechnologyClash of Opposing Philosophies

• Old World EU
• Process Orientation
• Foods are Different
• Political Precaution Guides Decisions
• Right to Know Labeling
• Biosafety Protocol

• New World US
• Product Orientation
• Foods are Equivalent
• Scientific Precaution Guides Decisions
• Nutrition and Risk-based Labeling
• WTO SPS TBT

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Plant-Made Pharmaceuticals Industrial Products
(PMP/PMIs)

• Pros
• Increased availability of orphan drugs
• Decreased costs for the pharma-chemical
  industries
• Increased economic opportunities for
  farmers/rural America

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Plant-Made Pharmaceuticals Industrial Products
(PMP/PMIs)

• Cons
• - Increased risks / costs for the agri-foodchain
  in
• . public health . financial
• . product recall . brand equity
• Loss of consumer confidence in the food supply,
  the food industry, the government,
• the technology

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U.S. Food Industry Objectives

• Protect our customers
• We eat too. So do our families and friends.
• Protect our brands
• Quality and safety and value
• Protect our bottom line
• Costs of notification, goods, retrieval
  replacement, time
• Average recall costs
• 500,000 minor recall, local production
• 5,000,000 national brand, one shift
• 12,000,000 entire national brand

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U.S. Food Industry Perspective

• Biotechnology and biopharming have great promise.
• However, pharming is not simply a variant of
  farming.
• Pharming is open-air drug and chemical
  manufacturing.

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U.S. Food Industry Perspective

• Needs to be regulated as tightly as
  brick-and-mortar facilities
• Process needs to be thoroughly coordinated
• Regulations need to be science-based
• Strong government oversight and enforcement.
• PMP/PMI production in food crops exposes the U.S.
  food industry to increased public health,
  regulatory and commercial risks.

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U.S. Food Industry Perspective

• Science indicates that these products can be
  isolated and separated from the food supply.
• Experience shows that these products will find
  their way into the food supply.
• So, how do we proceed in a manner that ensures
  continued consumer confidence in the safety and
  integrity of the food supply?

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U.S. Food Industry PMP/PMI Coalition

• American Bakers Association
• Biscuit Cracker Manufacturers Association
• Food Marketing Institute
• Grocery Manufacturers of America
• Institute of Shortening Edible Oils
• International Dairy Foods Association
• National Confectioners Association
• National Council of Chain Restaurants
• National Restaurant Association
• National Soft Drink Association
• Snack Food Association

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U.S. Food Industry PMP/PMI Comments

• FDA/CFSAN Early Food Safety Assessment (ESFA)
• USDA APHIS BSR to base permit requirement on
  EFSA.
• Increased Chain-of-Custody Requirements
  (Permit and SOPs)
• Prohibit PMP/PMIs in food crops until
  science-based regulations are in place.

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U.S. Food IndustryPMP/PMI Comments

• Ensure understanding of 100 permit compliance
  throughout the PMP/PMI chain of custody and the
  criminal penalties for such violations.
• Heighten APHIS/FDA oversight and enforcement at
  critical control points in the production and
  harvesting of PMP/PMIs.
• Address in advance potential remediation
  scenarios, how food recalls will be handled and
  communicated to industry and consumers, and
  related liability issues

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U.S. Food IndustryPMP/PMI Comments

• Exercise FDAs authority to impose a clinical
  hold on any IND or NDA if
• Production of a PMP is found to be unsafe or
• Demonstrated and repeated PMP permit
  noncompliance.
• Condition FDA approval on full compliance with
  APHIS permit requirements

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• Dont grow your drug-corn in the Corn Belt
  Dont Use Food Plants for Producing Drugs
• Editorial (Feb. 2004)

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PMP/PMIs

• Commercial development of PMP/PMI crops will
  exponentially increase PMP/PMI acreage and
  agri-food industry risk.
• Need to get it right the first time, every
  time.
• Lets responsibly harness the benefits of
  PMP/PMIs for consumers as well as minimize the
  agri-foodchain risks.
• Lets not move forward till government and
  industry have confidence in those measures.

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Grocery Manufacturersof America

• Karil L. Kochenderfer
• Biotechnology Coordinator
• klk_at_gmabrands.com
• 1010 Wisconsin, N.W. - 900
• Washington, D.C. 20007
• 202/337-9400

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Biotech Labeling? No Spontaneous Demand
No, dont want anything else More on nutrition,
fat, calories More on ingredients,
content Whether genetically modified
Alliance for Better Foods, 2001
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What are you most concerned about when it comes
to food safety?
Alliance for Better Foods, 2001