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This notice advises the public of the determination that a soybean line developed by Monsanto Co. is no longer considered a regulated article under USDA regulations regarding genetically engineered
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How to fill out Determination of Nonregulated Status for Soybean Genetically Engineered for Insect Resistance

01
Obtain the official 'Determination of Nonregulated Status' form from the appropriate regulatory agency.
02
Provide the name and contact information of the applicant in the designated section.
03
Clearly describe the soybean variety in question, including its lineage and traits.
04
Outline the genetic modifications made for insect resistance, detailing the methods used in genetic engineering.
05
Include data and results from safety assessments and environmental impact studies relevant to the genetically engineered soybean.
06
Submit all required supporting documents, such as test results and scientific literature, that validate the nonregulated status.
07
Pay any applicable fees associated with the submission of the form.
08
Ensure that the application is signed and dated before submission.

Who needs Determination of Nonregulated Status for Soybean Genetically Engineered for Insect Resistance?

01
Agricultural producers seeking to cultivate soybean varieties genetically engineered for insect resistance.
02
Companies involved in the research, development, and commercialization of genetically engineered soybeans.
03
Regulatory agencies assessing the safety and environmental impact of genetically engineered organisms.
04
Scientists and researchers studying the effects and regulation of genetically modified crops.
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The Determination of Nonregulated Status is a process conducted by the USDA Animal and Plant Health Inspection Service (APHIS) to assess whether a genetically engineered soybean, specifically engineered for insect resistance, poses any plant pest risk. If it is determined that the soybean does not pose such a risk, it may be granted nonregulated status.
Any entity, including companies or individuals, that develops or intends to cultivate soybean varieties genetically engineered for insect resistance is required to file for Determination of Nonregulated Status.
To fill out the Determination of Nonregulated Status, the applicant must complete the required forms, provide detailed information about the genetically engineered soybean, including its genetic modifications, potential environmental impact, methods of production, and research data that supports its nonregulated status.
The purpose of Determination of Nonregulated Status is to ensure that any genetically engineered soybean for insect resistance does not pose a risk to agriculture, the environment, or public health, thereby facilitating its approval for commercial cultivation.
The information that must be reported includes the genetic construct used, the stability of the trait, potential interactions with other organisms, environmental assessments, data on comparative agronomic performance, and any available scientific literature relevant to the engineered traits.
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