Title: BIOTECHNOLOGY The Perspective of the U'S' Food Industry February 2004 Karil L' Kochenderfer Grocery
1BIOTECHNOLOGYThe Perspective of the U.S.
Food IndustryFebruary 2004Karil L.
Kochenderfer Grocery Manufs. Of America
2Grocery 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
3GMA Member Companies
4Public 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)
5Risk 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
6Risk 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
7Risk 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)
8Risk 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
-
9Risk 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
-
-
10Risk 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
11Risk 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
12Risk Management Biotech Food Labeling
- FDA Labeling Policy
- Compositional Change
- Nutritional Change
- Health Issue (Allergenicity)
- Mandatory
- Applies to All Foods, including Biotech Foods
- Truthful, Nonmisleading
13Risk 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
14Proposed Biotech Food Labels
-
- GENETICALLY ENGINEERED
-
- United States Government Notice
- This Product contains Genetically Engineered
Materials, or was Produced with a Genetically
Modified Material -
15Biotech 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
16European 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
17National 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
-
18Risk 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
19Risk 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
20ds campaign targeting elloggs
21BiotechnologyClash 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
22Plant-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
23Plant-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
24U.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
25U.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.
26U.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.
27U.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?
28U.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
29U.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.
30U.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
31U.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
32-
- Dont grow your drug-corn in the Corn Belt
Dont Use Food Plants for Producing Drugs - Editorial (Feb. 2004)
33PMP/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.
34Grocery Manufacturersof America
- Karil L. Kochenderfer
- Biotechnology Coordinator
- klk_at_gmabrands.com
- 1010 Wisconsin, N.W. - 900
- Washington, D.C. 20007
- 202/337-9400
35Biotech 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
36What are you most concerned about when it comes
to food safety?
Alliance for Better Foods, 2001