The North American Millers’ Association (NAMA) supports food biotechnology as a tool that can improve product health, quality, safety and sanitation; increase production efficiency; allow more judicious use of agricultural chemicals and help meet growing domestic and world food demand.
NAMA supports the coordinated regulatory framework established by the U.S. government to oversee introduction of new products from biotechnology and its implementation by the Department of Agriculture, the Environmental Protection Agency and the Food and Drug Administration. This process must continue to be scientifically-based and rely on prudent risk-analysis.
NAMA supports the current food labeling policy of the U.S. Food and Drug Administration that requires special labeling only when the use of biotechnology introduces an allergen or when it substantially changes the food’s nutritional content.
NAMA supports educational efforts needed to assist with consumer understanding and acceptance of the safety review processes, benefits and innovations occurring in agricultural biotechnology.
NAMA recognizes that agricultural biotechnology, like other technologies, should find its place in an efficient, free marketplace. In that marketplace, consumers and individual food chain members may choose to consider a variety of factors in their decisions to buy and market products, including whether they are produced from biotechnology or conventional raw materials.
Understanding that millers are a vital link in the food chain between growers and consumers, NAMA believes that as this technology moves forward, it is imperative that:
1. The U.S. Government actively affirm the safety of products made from approved biotech crops and be pro-active in explaining the review process and the scientific basis for the commercialization of these products.
2. Technology providers and regulators consider the following recommendations that fall under the headings of:
• Mandatory FDA consultation
• Risk assessment
• Risk management (stewardship)
• Risk responsibility (liability)
• Functional traits
• Full lifecycle responsibility
• Identity preservation
• Major market approval
Mandatory FDA consultation
Prior to any new approvals or deregulation of biotech-enhanced events, biotechnology providers should be required to consult with the Food and Drug Administration (FDA) regarding such traits. This process should include biotechnology-derived crops producing pharmaceutical and industrial traits not intended for food or feed to ensure the integrity of the food and feed supply chain.
In reality, all biotechnology providers already voluntarily consult with FDA on the safety of each biotechnology-enhanced trait intended for use in food and/or feed. A missing component of the current consultation process is to establish a transparent, formal approval process through FDA under which biotechnology providers are required to demonstrate that biotechnology-enhanced events with functionally different output traits are substantially equivalent to their conventional counterparts in terms of maintaining the compositional and nutritional integrity of food and feed products.
The biotechnology provider or other applicant petitioning USDA’s Animal and Plant Inspection Service (APHIS) to deregulate genetically engineered organisms should be required to determine a threshold level, if any, at which it is inappropriate for such traits to be present in the general commodity stream because of potential adverse market access and/or food/feed safety or functionality impacts. Such threshold levels and the assessment and factual basis on which they were determined should be part of the public rulemaking record.
Technology developers should establish a level of comingling where the new product may impact the functional characteristics of the commodity (level of impact). When might there be a significant negative impact on the commodity supply chains? This data, once developed, should be a matter of public record.
Risk management (stewardship)
Based upon the results of the risk assessment, the biotechnology provider or other applicant petitioning APHIS should be required to develop, implement and enforce binding stewardship programs and supply chain management with which the technology provider is obligated to comply in a manner that is: 1) appropriate for the given biotech-enhanced trait; and 2) sufficient to prevent it from becoming present above established threshold levels in the commodity stream.
Having identified the level of potential impact, the petitioning technology developer should establish a unique supply chain to keep the product segregated, as well as guarantee that the product does not escape into the commodity supply chain until there are sufficient international approvals to justify comingling.
Risk responsibility (liability)
In cases where commercialization of agriculture biotechnology events occurs without full international authorization, or where products with unique functional characteristics (PUFCs) create prospective economic harm when introduced into the general commodity stream above levels shown to be de minimis, the technology developer should take responsibility for mitigation and redress for economic damage.
There is a need to address the commercialization of PUFCs. Key to any revision of USDA authority is to provide for coexistence between the technology companies seeking approval of new events, and commodity supply chains exposed to these deregulated events.
APHIS should be directed to develop a clearly defined, specific regulatory process for agricultural products that have unique functional characteristics (e.g., output traits) that may adversely affect the functionality and/or compositional and nutritional integrity of the product and downstream users. Such a process should include a requirement that the biotechnology provider or other applicant petitioning APHIS be responsible for establishing and enforcing an appropriate supply chain to keep the product segregated based upon fact-based threshold levels established through the risk-assessment process.
Full lifecycle responsibility
A comprehensive approach should create a regulatory process that establishes technology providers’ responsibility to implement domestic and global post-commercialization practices throughout the product’s life cycle, including for so-called legacy biotech events whose sale and distribution may be discontinued in the future. Such a regulatory policy also should require federal agencies to re-regulate previously deregulated biotech-enhanced events for cause, including if the biotech provider or applicant fails to comply with their stewardship (risk-management) and liability (risk-responsibility) obligations and commitments cited previously.
The U.S. grain marketing and processing system is extremely efficient and can move large amounts of grain quickly and economically. That strength, however, is balanced by the inability to guarantee 100 percent purity. Just as the official standards for grain allow small amounts of other grains, adventitious mixing can occur between biotech-based and conventional grains both in the field and in the system. Reasonable thresholds must be adopted to allow the movement of grains with adventitious admixture.
Test methods are highly sensitive and constantly evolving. The tests allow the miller to test incoming grain with a high degree of accuracy and precision. Where testing is warranted, once the grain has been tested on receipt, it should be allowed to move normally through commerce. NAMA opposes testing on intermediate or finished products because it creates the potential to establish liability where none previously existed.
Some U.S. millers currently use identity preservation (IP) systems to source non-biotech grains based on the premise the resources needed to support those systems are commensurate with the values received for them from the market. An IP system with incentives can create value for the producer through meeting specific market needs.
That description, however, is at odds with the segregation system that some are advocating for marketing biotech-based grains. They envision a system that channels grains with no added value creation. The addition of cost without value addition is unsustainable in a competitive global marketplace.
Finally, even with appropriate financial incentives in place, an IP system cannot operate with a zero tolerance standard. A zero tolerance standard is not a realistic expectation in the world’s supply chain environment.
Major Market Approval
All grains, with rare niche exceptions, have the potential to be traded under agreed upon terms for domestic processing or for export; whether for food, feed or industrial use. Likewise, processed grain products are used as ingredients in food products consumed throughout the world.
NAMA believes it is necessary that international frameworks be established for predictable, uniform and transparent regulatory practice that permits unfettered trade in all grain and grain products. NAMA urges the appropriate government agencies to work as diligently as possible in all available international forums to advance the acceptance of products developed through biotechnology. No biotech grains should be released until regulatory approval has been obtained in all major markets for bulk grains and food products, assuming these major markets have functional approval processes in place.
For grains currently in the U.S. market without broad international approval, we strongly encourage technology providers to discontinue selling those seed varieties unless approvals are received and/or suitable tolerances can be established.
NAMA offers these recommendations to illustrate the milling industry’s capabilities, and limitations, in dealing with biotechnology-based grains.
Prepared by Jim Bair, Vice President, 202.484.2200, ext. 14, [email protected]
First adopted October 2002
Last updated June 2013