The Biobased and Renewable Products Advocacy Group (BRAG) helps members develop and bring to market their innovative biobased and renewable chemical products through insightful policy and regulatory advocacy. BRAG is managed by B&C® Consortia Management, L.L.C., an affiliate of Bergeson & Campbell, P.C.

By Lynn L. Bergeson

The U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) issued a proposed rule on June 6, 2019, on the movement of certain genetically engineered (GE) organisms.  84 Fed. Reg. 26514.  The proposed rule would revise the regulations regarding the movement, including the importation, interstate movement, and environmental release of certain GE organisms in response to advances in genetic engineering and APHIS’ understanding of the plant pest risk posed by them, “thereby reducing regulatory burden for developers of organisms that are unlikely to pose plant pest risks.”  APHIS notes that the proposed rule “would mark the first comprehensive revision of the regulations since they were established in 1987.”  It would provide “a clear, predictable, and efficient regulatory pathway for innovators, facilitating the development of new and novel [GE] organisms that are unlikely to pose plant pest risks.”  Comments on the proposed rule are due by August 5, 2019. For further details, see the Bergeson & Campbell, P.C. (B&C) memorandum here.

Tags: USDA, APHIS

 

By Lynn L. Bergeson

On April 12, 2019, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced the reopening of the public review and comment period for the draft Environmental Impact Statement (dEIS) and the preliminary Pest Risk Assessment (PRA). These two documents have been prepared in response to a permit application from a company requesting the environmental release of genetically engineered (GE) Citrus tristeza virus (CTV). The reopening of comments is the result of a new research paper released after the initial comment period back in the summer of 2018. The research paper examines the movement of CTV, which could raise questions regarding the transmissibility of GE CTV. Updates to the dEIS and PRA have been made according to the new information obtained. While the dEIS evaluated the environmental impacts that could result from approving the permit application, the preliminary PRA analyzes the GE plant virus as a biological control measure and its potential to pose a risk to plant health. In its announcement, USDA APHIS clearly states that applying GE CTV does not mean that the trees are themselves GE. The permit application requests the approval for the use of GE CTV as a biological control agent that would help manage citrus greening disease. Instead, a gene from spinach is delivered to the tree’s circulatory system. Comments must be submitted on or prior to April 30, 2019.

Tags: USDA, APHIS

 

By Lynn L. Bergeson

On April 3, 2019, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced a request for comments on two documents related to the potential deregulation of a canola variety genetically engineered (GE) to convert oleic acid to docosahexaenoic acid (DHA) and eicosapentaeonic acid (EPA), as well as for resistance to an imidazolinone herbicide. The documents are a draft Environmental Assessment (dEA) and a draft Plant Pest Risk Assessment (dPPRA). While the dEA analyzes potential issues and environmental impacts, the dPPRA examines any plant pest risks. DHA and EPA are omega-3 fatty acids that support brain development and protect neurological function. The aforementioned GE canola accumulates higher concentrations of these fatty acids. Therefore, in a petition submitted by BASF Corporation (BASF), it stated that this canola provides a plant-based and scalable production system for omega 3-fatty acids that can be another source of EPA and DHA for consumers either as a food ingredient or as an aquaculture feed ingredient. Based on BASF’s statement and the draft documents, USDA will be accepting comments until May 6, 2019. APHIS intends to thoroughly review and consider the information provided in the completion of the final environmental documents and regulatory determinations.

Tags: USDA, APHIS, GE

 

By Lynn L. Bergeson

On March 19, 2019, USDA’s Animal and Plant Health Inspection Service (APHIS) Biotechnology Regulatory Services (BRS) announced the delay of the spring release for BRS’ updated permitting system in APHIS eFile.  The release is now expected to occur in mid-summer 2019, with periodic updates provided by APHIS BRS as the anticipated release approaches.  In its announcement, APHIS BRS highlighted its commitment to bringing a permitting system that takes advantage of USDA’s current capabilities and brings new features previously not available.

Tags: USDA, APHIS

 

By Lynn L. Bergeson and Carla N. Hutton

The United States Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) signaled on June 29, 2018, its intent to prepare a “programmatic environmental impact statement (EIS) in connection with potential changes to the regulations regarding the importation, interstate movement, and environmental release of certain genetically engineered [(GE)] organisms.”  The EIS will have a significant impact on how APHIS chooses to amend its regulation of GE organisms.  APHIS requested comment on issues to be considered in preparing the EIS, as well as how to define the scope of the alternatives and environmental impacts.  Comments are due July 30, 2018.
 
Our full memorandum provides some background, context, and a commentary regarding APHIS’ announcement.  

Tags: USDA, APHIS, GE

 

By Lynn L. Bergeson

On June 26, 2018, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced it was seeking public comment on a draft Environmental Assessment (EA) and a preliminary Plant Pest Risk Assessment (PPRA) prepared in response to a petition from Nuseed Americas Inc. (Nuseed) to deregulate a canola variety genetically engineered to convert oleic acid to docosahexaenoic acid (DHA).  83 Fed. Reg. 29742.  APHIS will thoroughly review and consider all public input submitted during the comment period, and use the information as it works to complete, and then publish, final environmental documents and its regulatory determination.

The Federal Register notice states that APHIS’ draft PPRA “has concluded that canola designated as event B0050–027, which has been genetically engineered to accumulate the long chain omega-3 fatty acid known as [DHA] in seed, is unlikely to pose a plant pest risk” and APHIS’ draft EA presents two alternatives “based on our analysis of data submitted by Nuseed, a review of other scientific data, field tests conducted under APHIS oversight, and comments received on the petition.”  The alternatives are:  “(1) Take no action, i.e., APHIS would not change the regulatory status of canola designated as event B0050-027, or (2) make a determination of nonregulated status of canola designated as event B0050-027.”  APHIS requests comments to be submitted by July 26, 2018.

Tags: USDA, APHIS

 

By Lynn L. Bergeson

On May 11, 2018, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced the availability of a draft Environmental Impact Statement (EIS) for public review and comment. This document evaluates the possible environmental impacts from a potential approval of a permit to release a genetically engineered (GE) Citrus tristeza virus (CTV) through Florida.  This GE plant virus would be used as a biological control agent to help manage Huanglongbing (HLB), or citrus greening disease, which can devastate the citrus industry. This notice is available in the Federal Register and is open for comments through June 25, 2018.

Tags: USDA, APHIS, EIS, Citrus

 

By Lauren M. Graham, Ph.D.

On November 7, 2017, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) issued a notice in the Federal Register announcing that it was withdrawing its proposed rule that would have revised the importation, interstate movement, and environmental release of certain genetically engineered (GE) organisms.  The proposed rule, which was issued on January 19, 2017, aimed to “update the regulations in response to advances in genetic engineering and understanding of the plant pest and noxious weed risk posed by [GE] organisms, thereby reducing burden for regulated entities whose organisms pose no plant pest or noxious weed risks.”  After reviewing public comments on the proposed rule, USDA decided to re-engage with stakeholders and explore alternative policy approaches.  More specific comments from USDA and the reasons supporting its decision are set forth in the notice.
 
While it appears that some in industry may welcome the withdrawal, most would agree that all stakeholders should work collaboratively and quickly to develop a new framework to speed the process to market, and to ensure the regulatory landscape is more efficient and clearer than it currently is.  USDA and pertinent others should immediately begin another process to enable the regrouping to begin.


 

By Lynn L. Bergeson and Margaret R. Graham

On November 7, 2017, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) issued a notice in the Federal Register (82 Fed. Reg. 51582) stating that it was withdrawing its January 19, 2017, proposed rule on the importation, interstate movement, and environmental release of certain genetically engineered (GE) organisms to “update the regulations in response to advances in genetic engineering and understanding of the plant pest and noxious weed risk posed by [GE] organisms, thereby reducing burden for regulated entities whose organisms pose no plant pest or noxious weed risks” (82 Fed. Reg. 7008).  Citing comments on the proposed rule critical of the proposed revisions, USDA stated it is committed to “explor[ing] a full range of policy alternatives” instead, and that it will “re-engage with stakeholders to determine the most effective, science-based approach for regulating the products of modern biotechnology while protecting plant health.”  More specific comments from USDA and the reasons supporting its decision are set forth in the notice.

While it appears that some in industry may welcome the withdrawal, most would agree that all stakeholders should work collaboratively and quickly to develop a new framework to speed the process to market, and to ensure the regulatory landscape is more efficient and clearer than it currently is.  USDA and pertinent others should immediately begin another process to enable the regrouping to begin. 


 

By Lynn L. Bergeson and Margaret R. Graham

On May 18, 2017, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) published a notice in the Federal Register announcing the dates it would be hosting three public meetings to provide the public with an opportunity to offer comments on the proposed revisions to its regulations regarding the importation, interstate movement, and environmental release of certain genetically engineered (GE) organisms.  82 Fed. Reg. 22802.  USDA has stated that it is updating its regulations “in response to advances in genetic engineering and [its] accumulated experience in implementing the current regulations, as well as [to] reduce the burden on regulated entities.”  The dates and locations for the public meetings are:

  • June 6, 2017, at the APHIS Center for Animal Welfare in Kansas City, Missouri;
  • June 13, 2017, at the University of California, Davis Conference Center, Davis, California; and
  • June 16, 2017, at the USDA Center at Riverside, Riverdale, Maryland. 

APHIS will be accepting comments on the proposed revisions until June 19, 2017, in Docket ID No. APHIS-2015-0057-0001Registration is available online.  The meetings will be webcast for those unable to attend in person.


 
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