North Dakota State Seed Commissioner warns of seed law violations.

As reported by North Dakota State University and Seedquest, the North Dakota State Seed Commissioner, Ken Bertsch, cautioned individuals to avoid seed law violations in the purchase and planting of protected varieties.

The prevalence of new technologies in the industry has led to more variety protection therefore, knowledge and adherence to seed laws becomes imperative for growers, seed conditioners and producers who maintain stocks of protected varieties of all types. Varieties protected by Plant Variety Protection (PVP) Title V can be sold only as a class of certified seed as will be designated by the individual states. Even those protected varieties outside PVP Title V purview, can only be sole with approval from the variety owner in the form of a license or some other IP rights granting agreement.

"In general terms, unless the seed being purchased is accompanied by a certified, registered or foundation class label or comes from a reputable dealer with authorization from the owner to market the seed, you shouldn't purchase and plant the seed," Bertsch says. "Brown-bagged seed isn't worth the risk and everyone involved in the transaction is a part of that risk pool."

As stated Bertsch cautioned to obtain seed through legal channels as it ensures all the proper rights are granted and applicable laws are applied. Brown-bagging or illegal transactions typically farmer-to-farmer does not have the ability to make these guarantees and can lead to fines levied by federal and state agencies from anywhere between $250 to $5000.

However, the kicker is the fact that the violation could potentially be used in civil infringement suit by the rights-holder of the illegal use of the protected variety. The damage award can be up to treble damages of the seed sold and grain derived from the planting. Seed Quest states that the violations of PVP and labeling laws have resulted in fines and fees upward of $50,000.

Bottom line – Learn the seed laws applicable to your enterprise, federal and state, and follow them as the initial fine may not be seem steep, but can quickly turn into much more. If you are found to be in violation of a seed law, please consult with counsel, preferably those familiar with the industry and agencies involved, in order to weigh out the options as there may be potential settlements with government agencies without an admission of guilt or some other more amicable alternative.

Deregulation of Genetically Engineered Plants by APHIS

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.

(Signature)_______________________________________________________

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.''

B. Certification

    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.

(Signature)_______________________________________________________

(Name of Petitioner)_______________________________________________

(Mailing Address)_________________________________________________

(Telephone Number)_______________________________________________

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.

Afterthoughts

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.

 

Federal Seed Act Labeling Requirements

The Federal Seed Act, 7 USCS § 1551, et. seq., is the starting point for compliance as it is akin to the truth-in-labeling law. The purpose of the Act, which has state counterparts that may require more disclosure or standards, is for everyone to know what is exactly in the bag. The Act generally applies to any vegetable or agricultural seeds, including lawn and forage seed, that are shipped in interstate commerce or will eventually be shipped in interstate commerce.

Labels are to be affixed to the containers or bags that inform the agricultural seed buyer of the name of the kind or kind and variety and percentage of each present, the lot number, origin if the Secretary believes this information is pertinent and is in excess of 5% of the whole, percentage of weed seeds and noxious-weed seeds, kinds of noxious-weed seeds and rate of occurrence which cannot be outside the acceptable standard, percentage of inert matter, percentage of weight of agricultural seeds not specifically labeled. Additionally, for any seed in presence of 5% or more, the percentages of germination and hard seed along with the month and date of such test that must be completed in the preceding five months. Most states have a seed lab that can help you with this last step. Additionally, there are private seed labs that also perform these tests. Last, but not least you must provide a name and address of the person who transports or delivers the seed or the person who is receiving the seed plus a code designation identifying the transporter.

Vegetable seeds are divided on whether the containers weigh one pound or more and one pound or less to determine the amount of disclosures required to be on the label. Both require names and percentages, hard seed and germination percentages, as well as identifying people to link the seed, but the one pound or more designation requires a lot designation similar to agricultural seeds.

All disclosures must be truthful, and evidence any form of treating the seeds may have received along with the generic name of the treating agent and whether it is safe for humans and animals. Any mercurials or toxic substances must follow the “Poison” label guidelines.

Violations of these labeling requirements can result in misdemeanor liability and civil fines, as well as a possible seizure of any mislabeled seed.

This post will get you into the ballpark of proper labeling. However, each state has its own accepted guidelines regarding allowable percentages that must be consulted before shipping to these states.

Introduction

This blog is meant to put out ideas and allow discussion about concerns facing the seed industry generally and individuals within the industry. The topics can cover issues regarding compliance, contracting, IP, start-ups, environmental concerns as well as a host of other interests and areas of concern that seem pertinent to the trade. Please enjoy and feel free to comment.