Race to the finish line for Monsanto's GE Alfalfa

This past Friday, the U.S. Supreme Court granted the petition of certiorari in order to hear the GE Alfalfa case, Monsanto Co. v. Geertson Seed Farms, No. 09-475, that has been causing quite a stir in the biotech world. This is fortuitous for many involved in biotech crops as a similar decision came out recently regarding Round-up Ready Sugar Beets. The Sugar Beet case had a similar result to alfalfa in that it required an Environmental Impact Statement (EIS) to look at possible consequences on the human environment instead of the less stringent Environmental Assessment (EA) that was performed by the Animal and Plant Health Inspection Service (APHIS). The petitioner's brief is due February 25, 2010 and the Respondent's Brief is due March 25, 2010, while the end of the October 2009 term for the U.S. Supreme Court is over in June 2010. This makes everything sound like it is on the fast track to hearing a decision relatively quickly, at least in terms of typical judicial time continuum.

However, there is a factor that could cause a concern with this case being heard if it is not rectified with an Order to Stay by the Supreme Court. The EIS that was ordered by the U.S. District Court in the N.D. of California has been completed by the USDA and the comment period is scheduled to close on February 16, 2010. The EIS came to a finding of no significant impact (FONSI) on the human environment, and more than likely, after review comments, APHIS will deregulate GE Alfalfa. This process could potentially take anywhere from 2-6 months depending on the amount of comments. I would expect there to be a lot of comments with the longevity and passion surrounding this issue, and the recent nod from the U.S. Supreme Court. This means the decision from USDA could be out sometime this summer. This could potentially cause a problem for Petitioner who wanted to create a precedent regarding deregulation of GE seeds, as the case may be moot by the time of oral argument or decision.

Article III of the U.S. Constitution has a case or controversy requirement that forms part of its standing analysis, (a.k.a. whether or not the person bring the suit is the proper party to bring the suit if one still exists). In order for a case to be heard there must have at least two litigants that have a controversy upon which the Court can issue a ruling. If the Alfalfa is deregulated prior to a ruling, than Monsanto no longer has a controversy as the alfalfa seed would be like it was prior to a suit ever being brought by a plaintiff, therefore creating a situation where the opinion would be an advisory opinion from the Supreme Court as the gravaman of the suit is moot.

This problem could be solved by Monsanto motioning for a stay of administrative procedures and the U.S. Supreme Court granting such a stay. This may have been done, but I have not seen anything evidencing it yet. The other way to have it solved is to have the Supreme Court move at the same speed of the famous Bush v. Gore case, but I would put my money on the former of my suggestions to occur first.

Comment Period extended for High-oleic acid soybean

Animal and Plant Health Inspection Service (APHIS) has sent out notice that it is extending the comment period for Pioneer Hi-Bred International's high-oleic acid soybean petition for nonregulated status. The original petition that was posted to go with the initial period was found to be the incorrect petition, so the comment period has been extended to December 28, 2009. The comment period is also extended for the Environmental Assessment (EA) and the Plant Pest Risk Assessment. The Federal Register notice from October 26, 2009 is posted here.

Mexico Issues First GM Corn Permits

According to a Reuters article from last week, The Mexican Agriculture Ministry will issue two permits to grow experimental plots of GM corn in regions where there are no native corn varieties. This will put the "birthplace" of corn in the hotbed of controversy over GM foods, but many feel it will help with productivity. The article further states that some Northern Mexico farmers were getting in the game early by illegally growing GM corn prior to any government approval of permits. Supposedly, thirty-five businesses have applied for the permits, including Monsanto.

This battle has gone back over the years, as it was always acceptable to consume GM corn in Mexico, but not plant or grow it. It was said that many farmers ignored this and planted the seeds anyway therefore causing an unintended spread of GM corn within Mexican fields. The report that is the centerpiece of this 2004 Washington Post article states that the proliferation of GM corn in Mexico was also contributed to cross-pollination (a.k.a. genetic drift). That about scares the hell out of most, so its understandable way many fears begin to align in these debates. We'll see how this further develops as this process gives us very interesting insight into the development of biotech plan and attitude that swirled by many of us in the US.

Consumer Choice sends Monsanto's Roundup Ready Sugar Beets back to the Deregulation Drawing Board

The Northern District of California handed down a ruling in Center for Food Safety v. Vilsack, No. C 08-00484 JSW (N.D. Cal September 21, 2009) that would requires the USDA to perform an Environmental Impact Statement (EIS) as opposed to an Environmental Assessment (EA) in their determination of whether to deregulate Genetically Modified Sugar Beets (known as Event H7-1). The court procedurally granted plaintiffs' motion for summary judgment and denied Defendants' cross-motion for summary judgment in order to line up its decision with the Geertson Seeds decision out of the Ninth Circuit regarding Roundup Ready Alfalfa.

The actual technology would make the sugar beets glysophate tolerant, which is similar to roundup ready alfalfa technology in the Geertson case. APHIS created an EA in response to the application for deregulation and reached a Finding of No Significant Impact (FONSI). The Court reasoned that the decision not to use the hard look of the EIS was arbitrary and capricious as there was evidence acknowledged by the agency, but cursorily tossed aside, that proved to be "significantly effect" the human environment as stated in the the procedural statute the National Environmental Policy Act (NEPA) .

The determination of whether an impact is significant will be determined by the context and intensity or severity, as it is defined by factors in 40 CFR 1508.27. The analysis of these will be reviewed by the judiciary under the APA's arbitrary and capricious standard. As stated, the Court found the Agency's conclusory statements regarding severity to deifferent factors arbitrary and capricious and ruled against it.

The evidence the court pointed to was the difference in opinion regarding length of time sugar beet pollen that can be carried by wind or animals was viable and the distance it could travel. In the related point that the Court considered significant was the socioeconomic effect on organic farmers or simply non-GMO farmers if genetic drift were to occur and consumer choice, if there is a significant limit of non-GMO sugar beets used in the market. Defedants countered that there was no real organic sugar beet market and that they simply do not have to take socioeconomic factors into the analysis of whether to issue an EIS. Obviously, the counter-arguments did not win the day. The Court reasoned that the socioeconomic and consumer choice factors were interrelated, if not a diresult of, the environmental factors that must be considered, and therefore carry as much weight.

Simple to this analysis is that consumer choice will be taken into account in the Ninth Circuit (if not elsewhere based on the focus of natural and organic products), and the skepticim especially abroad of GMO seeds should send a message to just use the EIS and scrap the EA in assessing deregulation possibility as of right now.

Tobacco may Help Diabetic Patients in the Future

SemBioSys Genetics Inc., out of Canada, was granted U.S. patent number 7,547, 821 entitled"Methods for the Production of Insulin in Plants". A similar patent was granted in Europe last year, and there are patent applications submitted in a multitude of countries worldwide according to the official company press release. The ever-increasing obesity problem that is facing the United States virtually guarantees great success on the patent as plant production is considered the fastest and cheapest methods of reproducing proteins. They will have a lock on the commercialization processes of this plant production method, I bet you wish you would have wanted to know this before its IPO last week.

From the abstract of the Patent "Production in seeds offers flexibility in storage and shipment of insulin as a raw material, and insulin retains its activity upon extraction from stored seed. Further, the amount of biomass subjected to extraction is limited, due to the relatively low water content of plant seeds." The benefits also include the cost factor in production as the scientists do not have to spend tons of money on generating the proteins within labs in small quantities. There is one aspect of the work that seems to worry me based on language in the patent. The claims of the patent seem to use tobacco, as it is typically an easy plant to use due to its regeneration and large pours that let you pop those proteins right out of the leaves in a vacuum chamber. However, it seems that the inventors would prefer to use the Arabidopsis (first plant that had its genome sequenced due to its simplicity), flax plant, or safflower. I am not sure the reason to steer away form tobacco, as it works well in demonstration scale tests, but perhaps its the perception, cost, complexity of the plant, or a host of other factors in which a learned expert in science or business could provide illumination.

This preference for other plants besides the Arabidopsis concerns me, as I believe it will give it a tougher time through the regulatory channels that transgenic crops must go through with APHIS and FDA. No one is much on tobacco, even smoking "unprocessed" tobacco is odious and the demand for consumption of Arabidopsis is virtually non-existent, so there would be no concern of these seeds getting into the food supply as there is no channel for these seeds. However, flax is being used more and more as an alternative to "traditional" foods with its presumed or known health effects, and safflower is used in vegetable oil and salad dressings. I believe this could cause more obstacles than need to be there during the regulatory phase as well as the possibility of public relations problems. This push-back from segments of the public can be seen in the opposition of corn's usage in pharmacropping.

I will continue to follow the progress of this company's patented invention as it continues its clinical trials and comment on the legal steps it will take and possible ramifications of actions taken while attempting to install it into the commercial chain.

I want to comment, and give credit, on where I get my base information to run off with into fanciful flights of legal discovery and opining upon all things seed. Please visit SeedQuest as they provide far more of an overview of the seed industry than my blog ever could, as they should. Another great resource for topic ideas and the most comprehensive blog regarding the extremely broad field of agricultural law is a combined effort of the National Agricultural Law Center and the American Agricultural Law Center, which can be found here.

-Craig

APHIS seeks comments on Genetically-Engineered Draft Standard

USDA-Animal and Plant Health Inspection Service (APHIS) is seeking comments until August 3, 2009 on its draft audit standard for the pilot Biotechnology Quality Management System (BQMS).

BQMS is a voluntary program that aims to enhance compliance with regulations for field trials and transportation of certain GE organisms, by compiling draft standards that utilize current regulations on environmental releases, importations and interstate movements. APHIS selected five participants in September, 73 Fed. Reg. 51266, for the BQMS pilot program that have applied the draft audit standard to their organization's regulated biotechnology program to plan, implement, document, and examine the efficacy of quality assurance and quality control measures related to introductions of regulated articles.

APHIS is seeking comments on the draft audit standard that is currently in use in the pilot program as a whole, and specifically Requirement 7 regarding critical control points for the introduction of regulated articles by developing containment procedures for regulated articles; developing measures for the identification of regulated articles in storage, being moved, imported, or transferred, and in field locations; developing procedures for planning and monitoring environmental releases of regulated articles; developing methods for post-harvest handling activities and methods to maintain the identity of regulated material; developing procedures for the devitalization and disposition of regulated articles; as well as developing procedures for the submission of regulatory compliance incidents to the appropriate regulatory authorities.

The specific questions to submit comments are:

1.) Does Requirement 7 cover all areas required to comply with 7 CFR Part 340?
2.) Is the draft audit standard consistent with current best practices for the regulated commodity?
3.) Are there identifiable incentives to encourage participation in the BQMS?
4.) Is the flexibility to apply to any organization apparent in the draft audit standard?

The notice can be found in the June 4, 2009 Federal Register at 74 Fed. Reg. 26831. A copy of the draft audit standard can be downloaded as a PDF from here!

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.