The Animal Plant Health Inspection Service (APHIS) regulates genetically engineered (GE) products and/or organisms along with the Environmental Protection Agency (EPA) and the Food and Drug Administration (FDA) depending on application or use. APHIS’ Biotechnology Regulatory Service (BRS) handles much of the actual permitting and notifying for transportation and interstate commerce of the GE products. Enough acronyms for now, essentially this post will show you how to petition for deregulation of a GE product or organism and what should go into the petition. As of the current date, APHIS has deregulated 75 GE products according to a press release deregulating GE cotton, found at http://www.aphis.usda.gov/newsroom/content/2009/05/cottonge.shtml .
So you find yourself having to fill out permits or notifying APHIS ever time you need to transfer your GE article even though you know its not introducing any plant pests or new plant pests that other organisms already bring into the environment. Well, there is two ways to be determined deregulated for purposes of permitting and/or notification procedures: submitting a new petition or submitting an extension to determine nonreglation base don an antecedent organism.
Submitting a Petition – The Long Haul
We will look at the first method of petitioning first as it will be more applicable for more novel scientific endeavors. The regulations located at 7 CFR 340.6 lay out the steps that need to be taken to petition the Administrator of APHIS for deregulation of a genetically engineered article. APHIS requires the petition to conform to the following format:
Petition for Determination of Nonregulated Status
The undersigned submits this petition under 7 CFR 340.6 to request that the Administrator, make a determination that the article should not be regulated under 7 CFR part 340.
A. Statement of Grounds
A person must present a full statement explaining the factual grounds why the organism should not be regulated under 7 CFR part 340. The petitioner shall include copies of scientific literature, copies of unpublished studies, when available, and data from tests performed upon which to base a determination. The petition shall include all information set forth in paragraph (c) of 7 CFR 340.6. If there are portions of the petition deemed to contain trade secret or confidential business information (CBI), each page of the petition containing such information should be marked ``CBI Copy''. In addition, those portions of the petition which are deemed ``CBI'' shall be so designated. The second copy shall have all such CBI deleted and shall have marked on each page where the CBI was deleted: ``CBI Deleted.'' If a petition does not contain CBI, the first page of both copies shall be marked: ``No CBI.''
A person shall also include information known to the petitioner which would be unfavorable to a petition. If a person is not aware of any unfavorable information, the petition should state, ``Unfavorable information: NONE.''
The undersigned certifies, that to the best knowledge and belief of the undersigned, this petition includes all information and views on which to base a determination, and that it includes relevant data and information known to the petitioner, which are unfavorable to the petition.
(Name of Petitioner)_______________________________________________
As stated in Section A of the Petition there is required data that must be submitted in the petition. You must:
(1) Submit a biological description of the unmodified recipient plant and information to identify narrowest taxonomic group of the recipient plant. This is the host plant as in the case of the deregulated cotton, it would be the cotton and the information concerning its narrowest taxonomic identifier;
(2) Provide relevant experimental data and publications that will give an overview of the GE article, including published and unpublished studies ad tests;
(3) Describe in detail the “ingredients” of the transformation of the unmodified organism into the regulated GE article including, the differences in genotype, any scientific or common name, as well as locality of the collection, development and production of the: donor organism, vector or vector agent, the inserted genetic material, and the regulated article. Be specific and transparent in these descriptions and remember to label “CBI” if you do not want your trade secrets in the public domain;
(4) Describe in detail the phenotype of the regulated article, while paying attention to the known and potential differences with the unmodified organism that would show that the GE article poses no greater plant risk than the unmodified organism. You should discuss plant pest risk characteristics, disease and pest susceptibilities, expression of the gene product, new enzymes, changes to the plant metabolism, weediness of the GE article and its possible effect on other plants, transfer of genetic information, environmental effects, and other relevant information that stays within the scope of the showing that the GE article poses no greater risk than the unmodified organism; and
(5) Provide Field Test Trial reports done under a permit or notification procedure that were done prior to the petition for nonregulated status or a submission for determination of nonregulated status based on an antecedent organism, which is a reference point organism that has already been determined nonregulated.
Filing and Administrative Steps
The Petition is then submitted with a copy to the Administrator at the address specified in the regulation, where it is stamped filed and assigned a petition number that will be used for all business related to the petition. After the filing, APHIS will publish a notice in the Federal Register.
The notice will specify a comments period for 60 days, where the agency will accept comments from any interested person and will utilize them to make a determination. The determination by APHIS will be made 180 days from the “receipt of the completed petition,” and it will either approve in whole or part or simply deny the petition. The petition will then be placed in the public petition file where it can be viewed.
Any person denied may file an appeal within 10 days of receipt of the written denial stating the facts and reasons for the appeal, including any after acquired information that could lead to an approval. This appeal is more or a re-petition as it goes back to the Administrator.
Requesting an Extension – The Express Lane
The second and more streamlined version for deregulation is employed if there is already precedent for deregulation of a similar article. You would request an extension of deregulation determination of an antecedent organism in order to cover your GE article and provide information showing the similarities based on similar criteria as set forth above in the petitioning section. However, unlike the petition there are no mandatory submissions.
APHIS will make a preliminary announcement in the Federal Register of an extension of the determination of nonregulated status 30 days before it is to become final and effective. The 30 days provides a cooling off period to allow other information to surface that may result in a denial of the extension.
If your request is denied, you can submit a modified request based on the rationale for the denial that will be received in the written denial or you can venture down the longer and more arduous process of filing a petition.
Although this may get you deregulated by APHIS, please remember that there are independent procedures for the EPA and FDA. I will attempt to discuss those in a later post.