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-2015-0057-0001. Registration is available online. The meetings will be webcast for those unable to attend in person.
According to a Federal Register notice published on February 5, 2016, 81 Fed. Reg. 6225, the U.S. Department of Agriculture's (USDA) Animal and Plant Health Inspection Service (APHIS) announced 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 notice identifies "reasonable alternatives and potential issues" to be evaluated in the EIS and requests public comments to define further the scope of the alternatives and environmental impacts and issues for APHIS to consider. Comments will be due March 7, 2016.
Under the Plant Protection Act (PPA), APHIS currently regulates the introduction (movement into the U.S. or interstate, or release into the environment) of GE organisms that may present a plant pest risk through its regulations in 7 C.F.R. Part 340, "Introduction of Organisms and Products Altered or Produced Through Genetic Engineering Which Are Plant Pests or Which There Is Reason to Believe Are Plant Pests." The notice notes that APHIS' regulation of certain GE organisms to protect plant health is aligned with the Coordinated Framework for the Regulation of Biotechnology (CF). While APHIS, the U.S. Environmental Protection Agency (EPA), and the U.S. Food and Drug Administration (FDA) are in the process of working to modernize a number of CF issues and activities, the Federal Register notice states "that effort is distinct from and entirely compatible with APHIS' effort to revise its biotechnology regulations" at 7 C.F.R. Part 340. The notice addresses only proposed changes to the APHIS regulations. More information on the efforts to modernize the CF, including two public engagement sessions that will be held in March 2016, is available on our website.
APHIS states that during the past 28 years of its regulation of certain GE organisms, advances in biotechnology and new issues raised by a range of stakeholders have emerged, and APHIS is considering amending the 7 C.F.R. Part 340 regulations pertaining to introductions of certain GE organisms to address the advances in biotechnology and the new issues raised by stakeholders. According to APHIS, this update would increase the "efficiency and precision" of its regulations. The proposed revisions would align the range of potential risks that APHIS may consider under Part 340 with both the plant pest and noxious weed authorities of the PPA, "to ensure a high level of environmental protection pursuant to APHIS' PPA authorities to regulate plant pest and noxious weeds, improve regulatory processes so that they are more transparent to stakeholders and the public, and provide regulatory relief to the extent possible so that unnecessary regulatory burdens are eliminated." APHIS states that the changes would ensure that it "can continue to effectively regulate the products of biotechnology that may pose plant pest or noxious weed risks to U.S. agriculture and the environment."
APHIS states that it is planning to prepare a programmatic EIS in connection with the proposed revisions and amendments that it is considering. The notice states that aspects of the human environment that may be potentially affected by such proposed regulatory revisions and amendments that APHIS has preliminarily identified for evaluation in the EIS will include:
- Potential impacts on U.S. agriculture and forestry production (e.g., conventional, biotechnology-based, and organic);
- Potential impacts on current and potential future uses of products of biotechnology in agriculture and forestry;
- Agronomic practices employed in biotechnology crop production that may have environmental consequences or impacts (i.e., tillage, crop rotation, and agronomic inputs);
- Potential impacts on aspects of the physical environment that include soil quality, water resources, air quality, and climate change;
- Potential impacts on aspects of the biological environment such as animal and plant communities, weed and insect resistance to herbicides and insecticides (respectively), the potential gene flow and weediness of regulated GE crop plants, and biodiversity;
- Potential impacts on consumer health and agricultural worker safety;
- Animal feed and health; and
- Socioeconomic considerations, to include potential impacts of regulated GE crop plants on the domestic economic environment, international trade, and coexistence among all forms of U.S. agriculture, conventional, biotechnology-based, and organic, in providing market demand for food, feed, fiber, and fuel.
Importantly, APHIS has preliminarily identified possible new definitions to be used in its proposed Part 340 biotechnology regulations for consideration and analysis in the EIS:
- Biotechnology -- Laboratory-based techniques to create or modify a genome that result in a viable organism with intended altered phenotypes. Such techniques include, but are not limited to, deleting specific segments of the genome, adding segments to the genome, directed altering of the genome, creating additional genomes, or direct injection and cell fusion beyond the taxonomic family that overcomes natural physiological reproductive or recombination barriers. This definition does not include and is intended not to include traditional breeding, marker assisted breeding, or chemical or radiation-based mutagenesis.
- Product of biotechnology -- An organism developed using biotechnology.
- Regulated organism -- An organism developed using biotechnology that poses plant pest or noxious weed risks as documented in an APHIS risk analysis that APHIS has determined to regulate.
APHIS states that it is considering, and invites public input on, these proposed definitions. Such input should address APHIS' regulatory objectives to safeguard agricultural plants and agriculturally important natural resources from plant pest or noxious weed damage (biological, chemical, or physical) caused by a "product of biotechnology," including its potential, or lack of potential to pose plant pest or noxious weed risks. APHIS will use these proposed definitions in the four proposed alternatives that it proposes to examine in the EIS. These proposed alternatives are:
- First Alternative: Take no action. Under this "no action" alternative, APHIS would make no changes to the existing 7 C.F.R. Part 340 regulations for certain GE organisms that pose a potential plant pest risk, and APHIS would continue to regulate certain GE organisms as it does today. APHIS would not revise its current regulations to add the definitions listed above. The No Action alternative represents the baseline against which the proposed revisions to the regulations will be compared.
- Second Alternative: Revise the current APHIS regulations concerning the introduction of certain GE organisms to provide for a process to review and regulate certain products of biotechnology to protect plant health; analyze potential plant pest and/or noxious weed risks first; and thereafter regulate only when appropriate and necessary. Under this alternative, APHIS would revise its current regulations to implement a two-step process that would ensure a thorough review of a product of biotechnology's potential to pose plant health risks (plant pest and/or noxious weed). According to APHIS, such a two-step process would enable it to consider and place risk-appropriate regulatory controls on the importation, movement, or "outdoor" use of those products that are determined to pose actual plant pest or noxious weed risks (regulate only when APHIS has determined that certain plant health risks are appropriate and necessary to require some regulatory action to be taken and implemented).
- Third Alternative: Revise the current APHIS regulations concerning the introduction of certain GE organisms to provide for the regulation of "products of biotechnology" as either plant pests or noxious weeds using the existing plant pest "analysis trigger" or a noxious weed "analysis trigger" that might classify plants produced through biotechnology as potential plant pests or noxious weeds. The notice states that under this third alternative, APHIS' proposed regulations would substantially increase oversight and resources over those currently used to regulate GE organisms. APHIS would not exempt certain "products of biotechnology" from APHIS regulatory oversight if a "product of biotechnology" was developed using a plant pest; or, if it posed a risk as a noxious weed pursuant to the PPA definition of a noxious weed. Introductions of products of biotechnology that posed a plant pest risk or noxious weed risk would require a permit and conditions would be applied for import, interstate movement, or "outdoor" use. APHIS states that its proposed regulatory scheme would include the range of actions and processes that would enable it to become, to the extent permitted by its PPA authorities, an "all-encompassing, wide-scale regulatory permitting authority," but still fully comply with the CF and support the continued development of products of biotechnology.
- Fourth Alternative: Withdraw the current 7 C.F.R. Part 340 regulations completely and implement a voluntary, non-regulatory consultative process for certain products of biotechnology whereby APHIS would document plant pest or noxious weed risks, if any, of certain products of biotechnology as defined above. Under this fourth alternative, developers would be responsible for ensuring that their respective products of biotechnology do not pose risks as a plant pest or noxious weed pursuant to their respective PPA definitions, and that their activities related to the importation, interstate movement, or release into the environment of their respective products of biotechnology are not in violation of any existing statutes or federal regulations that relate to plant pests or noxious weeds. Under this alternative, APHIS would not have a dedicated regulatory scheme to regulate specifically any products of biotechnology that may pose plant pest or noxious weed risks and therefore would not require consultation nor prescribe methods or practices related to any products of biotechnology. APHIS would manage any products of biotechnology that pose plant pests or noxious weed risks using its other existing regulations pursuant to the PPA; e.g., 7 C.F.R. Parts 330 and 360.
APHIS requests comments and information related to the topics and issues presented in the Federal Register notice so that the scope of the analysis in the draft EIS, including the types and range of reasonable alternatives, is "reasonable and appropriate," and proposed revisions to 7 C.F.R. Part 340 are well-evaluated. APHIS states that public input will be helpful in further defining the scope of the issues and reasonable alternatives under consideration. APHIS will publish a notice in the Federal Register to announce the availability of a draft EIS when it is issued and to invites the public to provide comments on it.
APHIS' efforts to solicit comment and consider potentially radical changes to its regulation of products of biotechnology are commendable. The notice reflects an awareness of the changing nature of the regulatory, commercial, and societal implications of the federal regulation of genetically modified organisms (GMO). The range of options under consideration cover the gamut -- from doing nothing, to regulating nothing and relying on voluntary efforts. As the public's attention has been focused in recent days on the Zika virus and the role genetically modified mosquitoes may play in fighting the explosive spread of the virus, the notice is likely to generate significant comment.
The invitation for comment on a wholesale set of options for how USDA should regulate GMO's is separate from the Administration-wide review of the CF. Whether EPA might invite similar public consideration of regulatory options on the merits of more, less, or the same level of review and regulation is unclear, and certainly has not been discussed publicly when EPA staff have described its actions under the Administration-wide review. Under the guise of reviewing the effectiveness of the current CF, some options for change to the EPA roles as they relate to USDA efforts might be part of what some stakeholders will want to comment on. As some of the USDA decisions to de-regulate traits then go to EPA for review under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), some observers may leverage the USDA review process as a means to prompt changes to the EPA process. Whether EPA would incorporate or even consider changes under the guise of its relationship to the USDA role would itself be a separate question.
On September 30, 2015, the U.S. Environmental Protection Agency (EPA) held a workshop on genetically engineered (GE) algae to give stakeholders an opportunity to hear about EPA's plans for improving its risk assessments of GE algae under the Toxic Substances Control Act (TSCA). Dr. Jeff Morris, Deputy Director of Programs for the Office of Pollution Prevention and Toxics (OPPT), welcomed participants and laid out the scope of the meeting: to assist EPA in understanding the questions it needs to ask and answer when it receives a Microbial Commercial Activity Notice (MCAN) for GE algae. Dr. Morris discussed how this workshop will contribute to EPA's broader effort to update the Points to Consider in the Preparation of TSCA Biotechnology Submissions for Microorganisms document that relates to other GE microorganisms, as well as the update to the federal Coordinated Framework on the Regulation of Products of Biotechnology. While updating the framework will assist EPA in handling risk assessments for GE algae, regulation will continue to be risk-based and determined on a case-by-case basis.
Members of EPA's biotech review team discussed aspects of MCAN review and pointed out particular areas where EPA seeks input, in particular:
- Taxonomy of algae;
- Propensity to transfer genetic material to other species;
- Ability to produce toxins or allergenic effects;
- How the growth rate and forms (unicellular or filamentous) might relate to exposure;
- Survivability of GE algae in the wild; and
- Propensity to out-compete wild populations of algae, and organismal control mechanisms.
The panel, as well as stakeholders, commented on how algae are different than traditional industrial microbes in some significant ways:
- The organisms are not as well studied, largely because, unlike bacteria and fungi, they have only recently been used for industrial production.
- Inactivation methods are quite different because of the protective cell walls that algae have, that most microbes lack.
Dr. Morris also made it clear that this meeting is just the beginning of the conversation. EPA continues to seek input from stakeholders on algae, in particular, and other GE organisms as part of EPA's effort to update the regulatory framework for GE organisms. Draft Charge questions are available on the workshop website, speaker presentations can be accessed through the meeting agenda webpage, and the deadline for written comments is October 31, 2015. More information on EPA's development and use of biotechnology is available in B&C's memorandum EPA Posts Information on Biotechnology Algae Project.
On August 14, 2015, the Department of Energy's (DOE) BioEnergy Science Center (BESC) announced the creation of a microbe that increases isobutanol yields by a factor of ten. The study, published in Metabolic Engineering, expanded upon a 2011 study where researchers were able to engineer genetically a microbe to produce isobutanol directly from cellulose. The new study used a higher yielding microbe with similar engineered traits, resulting in consolidated bioprocessing efficiency. This progress towards the commercialization of biobased isobutanol is important because its energy density and octane values are close to those of gasoline, allowing it to be used as either a direct replacement for gasoline or a chemical feedstock for a wide range of products.