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Herculex® I Safety Assessment Summary

Throughout the development of products derived through biotechnology, DuPont strives to maintain the highest standards to ensure product quality and product safety for farmers and consumers. On the basis of rigorous testing, regulatory agencies concluded that corn with Herculex* I insect protection is as safe as non-biotech corn. The Herculex I trait has received full food, feed and environmental approval by the United States and Canada. It has been approved for import by respective regulatory bodies in the European Union, Japan, Australia, New Zealand, South Korea, South Africa, and Philippines. Work to ensure our products will have appropriate regulatory approvals with other countries is continuing.

Before a biotech product can be introduced to the market, approval from appropriate governmental agencies is required. Following criteria established by the agencies, DuPont conducts extensive, validated tests for its biotech products. For the approval of corn with the Herculex I trait, extensive safety data was provided by Pioneer Hi-Bred International, Inc., and Dow AgroSciences LLC to the U.S. Department of Agriculture (USDA), Environmental Protection Agency (EPA), Food and Drug Administration (FDA) and the regulatory systems of other countries. Data on the genes and proteins used to develop the trait, crop characteristics, food and feed composition and environmental impacts were compiled over several years and from multiple environments in the United States and abroad.

The following tests were conducted on corn with the Herculex I trait:

Molecular Analysis

The plant genetic material (DNA) in corn with the Herculex I trait was analyzed to determine the functional integrity of the introduced genes that confer insect and herbicide resistance (cry1F and pat genes). The molecular analysis proved functional integrity by showing that the DNA segment used was properly integrated into the plant DNA.

Trait Stability

Trait stability and agronomic performance were monitored over multiple generations and environments. Plants of every generation were tolerant to the herbicide and resistant to infestation of target insects (European and southwestern corn borer, black and western bean cutworm, lesser corn stalk borer, southern corn stalk borer, sugarcane borer, corn earworm and fall armyworm). Continued stability is demonstrated through product performance.

Trait Specificity

Field trials and insect feeding studies demonstrated specificity of Cry1F protein to inhibit growth of the target insects. No adverse effects were observed when non-target animals (e.g. birds, fish and earthworms) and beneficial insects (e.g. ladybugs, honeybees and butterflies) were fed either purified Cry1F protein or appropriate plant material containing Cry1F (e.g. pollen).

Toxicity and Allergenicity

Both proteins used in corn with the Herculex I trait, Cry1F and PAT, are present in soil bacteria and are not considered as pathogens for humans or animals. Bt proteins similar to Cry1F have been used safely for many years as natural pesticides in commercial agriculture, including organic farming. PAT is used in several biotech crops and is not associated with toxicity or allergenicity.

Several studies demonstrated the safety of Cry1F and PAT proteins for human and animal consumption. Healthy mice demonstrated lack of acute toxicity after ingesting a dose of Cry1F or PAT protein many thousand times the estimated dietary intake of humans. In addition, a thirteen-week (90-day) oral toxicity feeding study in rats was carried out with grain from corn with the Herculex I trait and non-biotech corn grain. No significant diet-related differences were observed in the development or well being of the rats.

Both proteins were checked for characteristics typical of known allergenic proteins. There was no indication of allergenic potential.

Substantial Equivalent

The FDA reviews information showing that a biotech crop is equivalent to a non-biotech counterpart that has a history of safe food use. This is known as "substantial equivalence."   »  More [.pdf]

Compositional analysis and nutritional assessment of corn with the Herculex I trait were compared with non-biotech counterparts. Nutrients, like fat, protein, fiber, minerals, and vitamins, were measured. Long-term feeding studies also were conducted. There was no significant difference between corn with the Herculex I trait and the non-biotech corn. This finding means non-biotech corn and corn with the Herculex I trait are substantially equivalent. Another test for substantial equivalence involved long-term feeding studies with chickens and corn with the Herculex I trait. The studies indicated no difference in growth and health of the animals compared to those fed with non-biotech grain.

 

Herculex Insect Protection technology by Dow AgroSciences and Pioneer Hi-Bred. ®Herculex is a registered trademark of Dow AgroSciences LLC.