On February 1, 2016, the White House Office of Science and Technology Policy (OSTP) announced the dates and locations for the final two public engagement sessions covering the July 2, 2015 memorandum "Modernizing the Regulatory System for Biotechnology Products." The memorandum, issued under the Executive Office of the President (EOP) and jointly by (OSTP), the Office of Management and Budget, the U.S. Trade Representative, and the Council on Environmental Quality, directs the U.S. Environmental Protection Agency (EPA), the Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA) to update the Coordinated Framework for the Regulation of Biotechnology (Coordinated Framework). Three public engagement meetings were announced to develop a strategy to prepare the federal biotechnology regulatory system for the future of the biobased industry. The first meeting occurred on October 30, 2015, and more information has recently become available for the second and third meetings.
The second meeting will focus on current federal roles and responsibilities regarding biotechnology products. This meeting will occur on March 9, 2016, from 9:30 a.m. to 1:00 p.m. at EPA's Region 6 Office in Dallas, Texas. Registration is now open. To participate in person, registration should be completed by March 4, 2016. Registration is also required to view and participate in a live streaming of the public meeting. The third and final meeting does not yet have an agenda, but will be held on March 30, 2016, at the University of California's Davis Conference Center in Davis, California.
The Administration's efforts to modernize the Coordinated Framework are essential, laudable, and timely. It is imperative that stakeholders participate actively and effectively in sharing their experiences under the Coordinated Framework with the Administration. The forthcoming public meeting in Dallas is an excellent opportunity to communicate both successes and less successful experiences with the government's regulation of products of biotechnology. There is only one remaining public meeting opportunity after Dallas. After the third and final meeting, the Administration will assess all of the comments provided in response to the public meetings, and then will seek the public's comments on its thoughts on modernizing the Coordinated Framework. Stakeholders are urged to attend or participate virtually in the public meeting, and to help develop a more timely, efficient, and current governance framework for products of biotechnology.
Sign up through the EOP's website to be notified of future modernizing the biotechnology regulatory system activities.
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 February 1, 2016, the dates and locations for the last two public engagement sessions discussing the "Modernizing the Regulatory System for Biotechnology Products" memorandum were announced. The first meeting occurred on October 30, 2015, and a record of the meeting is available on the U.S. Food and Drug Administration (FDA) website. The second of the three meetings will be held on March 9, 2016, at the U.S. Environmental Protection Agency's (EPA) Region 6 office in Dallas, Texas. The third meeting will be held on March 30, 2016, at the University of California's David Conference Center in Davis, California. A Federal Register notice will be published with additional details on meeting times, agendas, and how to participate.
On January 12, 2016, the U.S. Environmental Protection Agency (EPA) issued a Federal Register notice announcing the availability of EPA’s response to a petition it received from the Biobased and Renewable Products Advocacy Group (BRAG®) under Section 21 of the Toxic Substances Control Act (TSCA). BRAG requested EPA to promulgate a rule pursuant to TSCA Section 8 that would establish a process to amend the list of natural sources of oil and fat in the “Soap and Detergent Association” (SDA) nomenclature system by considering the chemical equivalency of additional natural sources. While EPA denied the TSCA Section 21 petition, EPA left the door open for additional relief in this area and its notice provides useful information regarding options for doing so.
EPA concurred with BRAG that SDA nomenclature is currently limited to the listed sources. In its notice, EPA states, “[t]he petition correctly recognizes the current limitations of certain TSCA Inventory listings (i.e., those listings that incorporate particular assumptions about the natural sources of fats or oils from which the listed substance is derived, because they were named according to the SDA naming convention). Manufacturers of a new chemical substance that clearly falls outside the definitional scope of an existing chemical substance are not allowed to determine that the new chemical substance is nonetheless sufficiently ‘similar’ to the existing chemical substance, and simply deem the new chemical substance to be an existing substance on the basis of that similarity.”
While not providing details as to how it could be accomplished, EPA’s response seems to indicate that there may be opportunities for BRAG to achieve its goal. EPA stated “the petition presumes, without justification, that until a certain preliminary EPA rulemaking has been completed, those same manufacturers lack a meaningful opportunity to request that EPA enlarge the definitional scope of one or more existing chemical substances named according to the SDA naming convention.” “Although the response indicates that the current SDA Nomenclature system is limited to the original 35 sources, it is encouraging that EPA does not see a regulatory barrier to adding additional sources,” stated Richard E. Engler, Ph.D., Senior Chemist with Bergeson & Campbell, P.C. (B&C®) and BRAG advisor. Further, “[t]his language appears to support the contention that there may be an opportunity to request EPA to expand the SDA naming convention beyond the current list of 35 plant and animal sources.”
Similarly, Kathleen M. Roberts, Executive Director of BRAG, stated “BRAG is encouraged by the language in Assistant Administrator James J. Jones’ letter to BRAG, in which he highlighted Section 5(h)(4) as a potential mechanism to achieve BRAG’s goal with the Section 21 petition.” Section 5(h)(4) allows EPA to develop a rulemaking for exemption of certain chemical substances if EPA determines that the manufacture, processing, distribution, use, or disposal will not present an unreasonable risk.
Ms. Roberts also stated that “BRAG members are evaluating next steps, including careful consideration of the potential pathways to achieve the ultimate goal of the petition that EPA identified in its response.” As part of its 2016 efforts, BRAG is expanding its membership to include more companies that have already been or may be adversely impacted by EPA’s current naming convention policies, such as companies looking to produce bio-based chemicals from algae or non-traditional plant materials.
On December 14, 2015, the U.S. Environmental Protection Agency (EPA) published the Renewable Fuel Standard (RFS) Program: Standards for 2014, 2015, and 2016 and Biomass-Based Diesel Volume for 2017 in the Federal Register. The final rule will become effective on February 12, 2016, and establishes annual percentage standards for cellulosic biofuel, biomass-based diesel, advanced biofuel, and total renewable fuel for motor vehicle gasoline and diesel produced or imported in the years 2014, 2015, and 2016 and biomass-based diesel for 2017. More information regarding the RFS final rule is available in the Biobased and Renewable Products Advocacy Group's (BRAG®) article EPA Releases Final Renewable Fuel Standard Rule.
On November 19, 2015, USDA published a Notice of the Advisory Committee on Biotechnology and 21st Century Agriculture (AC21) Meeting in the Federal Register. The meeting will review the purpose, history, operational process, and member responsibilities of AC21; update committee members on relevant regulatory developments, initiatives, and USDA activities; and outline new tasks for the committee to address. There will also be an opportunity for members of the public to make oral statements, as long as they contact Dr. Michael Schechtman about presenting a statement at least three business days before the meeting. The meeting will be held in Washington, D.C. on December 14 and 15, 2015, from 8:30 a.m. to 5:00 p.m. on both days.
On October 16, 2015, the U.S. Food and Drug Administration (FDA), along with the Office of Science and Technology Policy (OSTP), the U.S. Environmental Protection Agency (EPA), and the U.S. Department of Agriculture (USDA) announced in the Federal Register a public meeting Clarifying Current Roles and Responsibilities Described in the Coordinated Framework for the Regulation of Biotechnology and Developing a Long-Term Strategy for the Regulation of the Products of Biotechnology. The meeting is intended to discuss FDA's role in responding to the July 2015 Executive Office of the President (EOP) memorandum "Modernizing the Regulatory System for Biotechnology Products" and will invite oral comments from interested parties. The meeting will be held on October 30, 2015, at FDA's White Oak Campus in Silver Spring, Maryland. Registering early is recommended due to limited space. The deadline for written comments is November 13, 2015. For more information or to register for this meeting, visit FDA's website.
On October 19, 2015 the Federal Register published a correction to the due date for comments for the Notice of Opportunity To Comment on an Analysis of the Greenhouse Gas Emissions Attributable to Production and Transport of Jatropha Curcas Oil for Use in Biofuel Production. The October 15, 2015, Biobased and Renewable Products Update included the article EPA Issues Draft GHG Analysis For Production and Transport of Jatropha Oil that listed the incorrect date for comments to be received. The correct date that comments must be received by is November 12, 2015.
In a memorandum dated October 15, 2015, the U.S. Environmental Protection Agency’s (EPA) Office of Inspector General (OIG) stated that it plans to begin preliminary research on the lifecycle impacts of EPA’s renewable fuel standard (RFS).
The stated objectives from the memorandum are to determine whether EPA: (1) complied with the reporting requirements of laws authorizing the RFS; and (2) updated the lifecycle analysis supporting the RFS with findings from the statutorily mandated National Academy of Sciences’ (NAS) 2011 study on biofuels entitled Renewable Fuel Standard, Potential Economic and Environmental Effects of U.S. Biofuel Policy (NAS Study), EPA’s 2011 Biofuels and the Environment: First Triennial Report to Congress (2011 Report), and any subsequent reports or relevant research on lifecycle impacts of biofuels. OIG plans to perform this work within EPA’s Office of Air and Radiation and Office of Research and Development.
The NAS Study makes the following key finding in terms of the environmental effects of increasing biofuel production: “The environmental effects of increasing biofuel production largely depend on feedstock type, site-specific factors (such as soil and climate), management practices used in feedstock production, land condition prior to feedstock production, and conversion yield. Some effects are local and others are regional or global. A systems approach that considers various environmental effects simultaneously and across spatial and temporal scales is necessary to provide an assessment of the overall environmental outcome of increasing biofuel production.” Further, “[a]lthough using biofuels holds promise to provide net environmental benefits compared to using petroleum-based fuels, the environmental outcome of biofuel production cannot be guaranteed without a landscape and life-cycle vision of where and how the bioenergy feedstocks will be grown to meet the [revised standards (RFS2)] consumption mandate. Such landscape and life-cycle vision would contribute to minimizing the potential of negative direct and indirect land-use and land-cover changes, encouraging placement of cellulosic feedstock production in areas that can enhance soil quality or help reduce agricultural nutrient runoffs, anticipating and reducing the potential of groundwater overdraft, and enhancing wildlife habitats.”
EPA’s 2011 Report, actualized by the 2007 Energy Independence and Security Act, requires EPA to revise the RFS program to increase the volume of renewable fuel blended into transportation fuel from nine billion gallons per year in 2008 to 36 billion gallons per year by 2022. It concludes that: (1) the extent of negative impacts to date were limited in magnitude, and are primarily associated with the intensification of corn production; (2) whether future impacts are positive or negative will be determined by the choice of feedstock, land use change, cultivation, and conservation practices; and (3) realizing potential benefits will require implementation and monitoring of conservation and best management practices, improvements in production efficiency, and implementation of innovative technologies at commercial scales. Biofuels compared included conventional and cellulosic ethanol and biodiesel.
More information on other biobased issues and RFS issues is available on Bergeson & Campbell, P.C.’s (B&C®) Biobased Products, Biotechnology web page and its Fuel and Fuel Additives web page.