Forecast for U.S. Federal and International Chemical Regulatory Policy 2019: UNITED STATES CHEMICAL FORECAST - Nanotechnology, Biotechnology and BRAG
1. Reporting Rule for Existing Chemical Nanoscale Materials
Under EPA’s January 12, 2017, TSCA Section 8(a) reporting rule for certain chemical substances already in commerce as nanoscale materials, persons who manufactured or processed a reportable chemical substance during the three years prior to the final effective date of the final rule had until August 14, 2018, to submit information to EPA. There is also a standing one-time reporting requirement for persons who intend to manufacture or process a discrete form of a reportable chemical substance on or after the effective date of the rule. These persons must report to EPA at least 135 days before manufacturing or processing of that discrete form. EPA has stated that it will use the data to decide if further action under TSCA, including additional information collection, is needed. More information regarding the final rule is available in our January 12, 2017, memorandum, “EPA Promulgates Final TSCA Reporting and Recordkeeping Rule for Nanoscale Materials.” Our August 14, 2017, blog item “EPA Publishes Final Guidance as Final TSCA Section 8(a) Rule Takes Effect” provides information on EPA’s final guidance.
2. Draft Current Intelligence Bulletin (CIB) for Silver Nanomaterials
In September 2018, the National Institute for Occupational Safety and Health (NIOSH) issued a revised draft Current Intelligence Bulletin: Health Effects of Occupational Exposure to Silver Nanomaterials. NIOSH first released a draft CIB on silver nanomaterials in January 2016. Unlike the 2016 draft, the 2018 draft includes a recommended exposure limit (REL) for silver nanoparticles (<100 nanometers (nm) primary particle size) of 0.9 micrograms per cubic meter (μg/m3) as an airborne respirable eight-hour time-weighted average (TWA) concentration. The REL would apply to processes that produce or use silver nanomaterials. In 2019, NIOSH will be reviewing peer reviewer and stakeholder comments on the revised draft CIB and making any necessary changes as it prepares the final CIB. In addition, NIOSH will be completing peer and stakeholder review of a draft CIB concerning approaches to developing occupational exposure limits or bands for engineered nanomaterials.
Even without urging from the White House Office of Science and Technology Policy, EPA, the FDA, and the U.S. Department of Agriculture (USDA) have all taken steps to modernize the biotechnology regulatory system, embracing the spirit of the 2017 National Academies of Sciences, Engineering, and Medicine report, “Preparing for Future Products of Biotechnology.” This progress is expected to continue in 2019.
In October 2017, the EPA Office of Pesticide Programs’ (OPP) Biopesticide and Pollution Prevention Division (BPPD) reorganized to create the new Emerging Technologies Branch (ETB). ETB’s scope of responsibility includes the registration of pesticides that are the product of biotechnology. The growing ETB portfolio includes pesticides that are plant-incorporated protectants (PIP), genetically-engineered (GE) microbes, and GE mosquitoes. In 2019, ETB will continue to expand as it navigates the data requirements, risk assessment approaches, and regulatory issues applicable to the novel technologies that it encounters in submitted experimental use permit and product registration applications. BPPD recently projected that its future biotechnology registration activities may include products of synthetic biology, genome-edited PIPs, RNA interference products, and possibly eventually gene drives.
In 2019, FDA will continue to implement its Plant and Animal Biotechnology Innovation Action Plan. The Action Plan advances policy priorities that FDA will pursue to clarify its science-and-risk-based approach for product developers; avoid unnecessary barriers to future innovation in plant and animal biotechnology; and advance safety and FDA’s public health mission. As a first step, FDA will adopt a comprehensive policy framework for the development and regulatory oversight of animal biotechnology products, including for intentionally genetically altered animals and the food and drug products derived from them. According to FDA, this flexible framework will advance its commitment to safety while promoting innovation. As part of this effort, FDA intends to publish two guidance documents in 2019 that will provide more clarity on how FDA is applying its regulatory oversight to evaluate new animal biotechnology products based on the risk profile of various products.
In October 2018, FDA and USDA jointly hosted a meeting, “The Use of Cell Culture Technology to Develop Products Derived from Livestock and Poultry.” Both FDA and USDA had claimed oversight of cell-cultured meat (also referred to as lab-grown meat, clean meat, in vitro meat, imitation meat, synthetic meat, and fake meat), which is grown in laboratories from animal cell-cultures. In a November 16, 2018, statement, the agencies announced that they concluded that “both the USDA and the FDA should jointly oversee the production of cell-cultured food products derived from livestock and poultry.” The agencies announced an agreement on a joint regulatory framework wherein FDA oversees cell collection, cell banks, and cell growth and differentiation. A transition from FDA to USDA oversight will occur during the cell harvest stage. USDA will then oversee the production and labeling of food products derived from the cells of livestock and poultry. FDA and USDA “are actively refining the technical details of the framework, including robust collaboration and information sharing between the agencies to allow each to carry out our respective roles.”
USDA is working on several fronts to address biotechnology issues in 2019. On December 21, 2018, USDA promulgated a final rule establishing the National Bioengineered Food Disclosure Standard (Standard). The new Standard requires food manufacturers, importers, and other entities that label foods for retail sale to disclose information about bioengineered (BE) food and BE food ingredient content. The Standard is intended to provide a mandatory uniform national standard for disclosure of information to consumers about the BE status of foods. Following publication of the Standard, USDA will provide outreach and education to inform regulated entities and the public about the new disclosure terms. The Standard includes the following initial compliance dates: (1) except for small food manufacturers, entities responsible for BE food disclosure must comply with the requirements of this part by January 1, 2020; and (2) small food manufacturers must comply with the requirements of this part by January 1, 2021.
USDA’s 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 organisms.” When published, 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. According to an item in APHIS’s Fall 2018 Regulatory Agenda, APHIS intends to publish in April 2019 a proposed rule to update the regulations in response to advances in genetic engineering and APHIS’s understanding of the plant health risk posed by GE organisms, thereby reducing the burden for regulated entities whose organisms pose no plant health risks. More information is available in our July 24, 2018, memorandum, “APHIS/USDA Prepare to Revise Regulations Pertinent to Genetically Engineered Organisms.”
Biobased and Renewable Products Advocacy Group (BRAG®)
The trajectory for development of new biobased and renewable chemical products is promising in 2019 given the growing sustainability objectives for many companies and their stockholders. As these new sustainable chemistries are developed and become available for commercialization, the Biobased and Renewable Products Advocacy Group (BRAG®) is ready to be part of the solution to facilitate their availability on the market. A key objective of BRAG in 2019 is to address the regulatory challenges related to naming conventions as outlined in its April 2018 white paper, “Proposal for a Toxic Substances Control Act (TSCA) Inventory Representation and Equivalency Determinations for Renewable and Sustainable Bio-based Chemicals.” BRAG intends to coordinate with EPA staff and leaders within the biobased chemical industry to outline a process that allows for Class 2 chemical equivalency determinations for chemistries derived from different sources.
Biobased industry stakeholders are encouraged to express support for the initiative and the allocation of resources to address the recommendations outlined in the white paper. The next generation of biotechnology products may be on the line if a modernized and more efficient regulatory system is not developed.
Although it remains unclear whether and how far the Trump Administration will carry on with these demands, global and national policy reforms are increasingly focusing on renewable chemistry as a critical part of addressing climate change. The U.S. Department of Energy (DOE) Bioenergy Technologies Office (BETO), for example, has announced a request for information (RFI) on algae, biomass, and waste feedstocks that can be used in the production of biofuels, bioproducts, and biopower. Additionally, DOE funding opportunities in 2019 will concentrate on incentivizing biotechnology and energy efficiency through renewable and sustainable sources. This shift in focus is also expected throughout the globe as the United Kingdom (UK), Canada, and Finland, among other nations, emphasize the need for collaboration and transformations necessary to encourage growth of the bioeconomy.
It is expected that agencies involved in regulation of future biotechnology products, such as EPA, FDA, DOE, and USDA, will increase scientific capabilities, tools, expertise, and horizon scanning in key areas of expected growth of biotechnology, including natural, regulatory, and social sciences. We can also foresee such agencies further increasing their use of pilot projects to advance the understanding and use of ecological risk assessments and benefit analyses for future biotechnology products. The biobased industry should plan to remain engaged in all aspects of TSCA implementation to ensure regulatory parity with traditionally-sourced chemicals and to avoid additional obstacles to commercialization.