The Petition Process: A Guide for New Users to 7 CFR §340.6
We developed this guide to assist the first time user planning to seek a determination of nonregulated status through the Biotechnology Regulatory Services (BRS) petition process. This guidance is by no means an exhaustive list of all considerations and resources; rather it is intended to provide an overview to assist you in considering and preparing an effective petition application. The earlier you start planning your research to incorporate petition submission requirements, the more likely you are to avoid delays.
Considerations in planning for a petition:
1. Request a meeting with APHIS BRS. All developers, including public sector and small company developers, are encouraged to talk with APHIS as early as possible in the research and development process; we can help you understand the data requirements for a petition and this can prevent unnecessary delays. We can arrange face-to-face meetings, teleconferences, and web-based communications with you. BRS contact information is provided here.
2. Engage with BRS in your project design. Your design options (organism, DNA donor, gene sequence, mechanism of transformation, etc.) can affect your regulatory status and the information we will need from you. For example, plant pathogens are often used as donors or vectors in the development of a GE organism and these choices can affect your regulatory status. We can work with you on the information we will need based on your project design. Additional guidance is provided here.
3. Review a petition for a plant with similarities to your new plant variety. Petitions that have been deregulated are available here.
(Scroll down to the table labeled, Determinations of Nonregulated Status, and you can click on the green arrow under the column labeled Petition and Preliminary Assessment and view actual petitions to use as a reference.) Good examples of petitions submitted by specialty crop developers that have received determinations of nonregulated status are petition no. 04-264-01p, the plum pox virus-resistant plum, and petition no. 04-337-01p, papaya ringspot virus-resistant papaya.
4. Understand the petition submission process. Our regulations outline requirements for the petition process. When you are ready to submit your petition application, check the specific submission requirements under 7 CFR §340.6 detailed here. You may also have questions about treatment of confidential business information (CBI) in your petition; here is a resource to assist you. For questions regarding CBI, contact the APHIS BRS Document Control Officer: email@example.com.
5. Current scientific knowledge can be used to respond to information needed for submitting a petition. It’s not always necessary to generate new experimental data to address information needs. Relevant information may already exist in the peer reviewed scientific literature.
6. Include favorable and unfavorable data and information and discuss the relevance of this information in your petition application. Be explicit in your explanations; don’t assume the conclusions you have reached are obvious.
7. Get expert assistance in areas where you are not an expert (e.g., statistics, environmental consequences, etc.). No one can be an expert in everything, and getting the help you need to present your information clearly and with appropriate rigor can reduce delays.
8. Submit a complete and well-written document. One of the first steps in our petition review is to verify that it is complete. Guidance for writing a petition can be found here. This guidance can be used for planning and providing the appropriate information to BRS. Make sure there are no spelling or grammatical errors, and that your text is consistent with your data. Click here for more information on how to prepare documents for submission to BRS.
9. Consider conferring with EPA and/or FDA. Your GE plant may also be regulated by the Environmental Protection Agency (EPA) and/or the Food and Drug Administration (FDA). For more information on how your GE organism may be regulated, click here. To get started with EPA, contact Nicole Berckes at firstname.lastname@example.org. To get started with FDA, contact their Office of Food Additive Safety at email@example.com.
If you are uncertain whether or not your GE plant or organism is regulated by BRS, first review the “Am I Regulated” Process outlined here. If you need additional assistance after reviewing the process, please contact BRS.
Prior to submission of a petition for non-regulated status, developers conduct field tests. Additional information about field test requirements and the need for a permit or notification can be found here.
Presentations from the “Specialty Crop Regulatory Assistance Workshop: Nuts and Bolts of US Regulatory Dossiers for Genetically Engineered Crops,” held in 2011 and sponsored by the National Institute of Food and Agriculture.
|List of Useful Links Cited Above|
|“Am I Regulated”|
|About Permits, Notifications and Petitions|
|Guidance for Petitions|
|BRS General Document Preparation Guidelines|
|BRS Petitions Table|
|How the U.S. Regulates Biotech Plants|
|7 CFR § 340.6|
|Confidential Business Information (CBI)|