APHIS/USDA Prepare to Revise Regulations Pertinent to Genetically Engineered Organisms

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.
 
The Plant Protection Act (PPA) authorizes APHIS to protect domestic plant health. Under the PPA, APHIS regulates the introduction of organisms that may present a plant pest risk.  APHIS’ regulations are intended to protect against plant pest risks to plant health by providing for the safe importation, interstate movement, or release into the environment of GE organisms.  APHIS’ regulation of GE organisms to protect plant health is aligned with the federal Coordinated Framework for the Regulation of Biotechnology (Coordinated Framework), the federal regulatory policy intended to ensure the safety of biotechnology research and products in the U.S.  The Coordinated Framework sets forth a science- and risk-based approach for the oversight of biotechnology products released into the environment and describes the roles and responsibilities for the three federal agencies involved in regulating biotechnology products:  USDA (via APHIS), the U.S. Environmental Protection Agency (EPA), and the U.S. Food and Drug Administration (FDA).
 
There have been major advances in the science of biotechnology over the decades since the Coordinated Framework was developed in 1986, and new issues have been brought to APHIS’ attention by diverse stakeholders.  The June 29, 2018, Federal Register notice announces APHIS’ consideration of amending the regulations pertaining to the movement and outdoor use of certain GE organisms to address the advances in biotechnology and APHIS’ understanding of the issues raised by stakeholders.  Under the provisions of the National Environmental Policy Act of 1969 (NEPA), federal agencies must examine the potential environmental impacts of proposed federal actions and alternatives.  APHIS is planning to prepare an EIS in connection with the proposed revisions to APHIS’ biotechnology regulations that are being considered. Aspects of the human environment that may be affected by the proposed regulatory changes and that APHIS has identified for evaluation in the EIS include potential impacts on:

• U.S. agriculture and forestry production (e.g., conventional, biotechnology-based, and organic);
• Current and future uses of certain GE organisms in agriculture and forestry;
• Agronomic practices employed in GE crop production that may have environmental consequences or effects (e.g., tillage, crop rotation, weed and pest control, and agronomic inputs);
• Aspects of the physical environment, including soil quality, water resources, and air quality, with consideration given to the effects of dynamic climate conditions;
• Aspects of the biological environment, such as animal and plant communities, the development of weed, pathogen, and insect resistance to pesticides, the potential gene flow from certain GE organisms to sexually compatible species, the weediness of GE crop plants, and biodiversity;
• Consumer health and agricultural worker safety; and
• Animal feed safety, availability, quality, and animal health.

Commentary

We have written extensively on the need to update the regulation of GE organisms, as well as the update to the Coordinated Framework.  The APHIS announcement joins the earlier FDA announcement of its formation of a new Biotech Working Group and preparation of an action plan.  The plan reportedly will focus on the steps FDA intends to take to ensure that it has a flexible regulatory framework for evaluating the safety of products while also supporting plant and animal biotechnology innovation.  FDA’s action will focus on three key areas:  (1) advancing and protecting public and animal health by promoting innovation through an efficient and predictable science- and risk-based regulatory framework; (2) strengthening public outreach and communication through strong, effective, and transparent engagement with stakeholders; and (3) increasing engagement with domestic and international partners through coordinated and collaborative actions to support regulatory alignment and efficiency.
 
The culmination of these initiatives, guided by stakeholder comment and input, will greatly assist in developing a compelling, effective, and updated governance framework for GE organisms.  As of July 24, 2018, only eight comments have been submitted to APHIS on its notice of intent to prepare an EIS.  APHIS has requested public comment to help it further define the issues and alternatives that should be considered and to help it identify additional impacts to the human environment that should be considered in the EIS.  APHIS states that public comment will also be helpful in helping it develop proposed regulations, and that it will carefully consider all comments received.