Abstract
I
Back in July of 2015, the Executive Office of the President (EOP) directed these primary agencies to update the Coordinated Framework, which first issued in 1986, and was updated in 1992. The administration asked for three tasks to be accomplished:
1. Clarify the current roles and responsibilities of the EPA, FDA, and USDA in the regulatory process; 2. Develop a long-term strategy to ensure that the federal regulatory system is equipped to assess efficiently the risks, if any, of the future products of biotechnology; and 3. Commission an expert analysis of the future landscape of biotechnology products.
In September of 2016, a proposed Update to the Coordinated Framework was published for public comment, as well as the National Strategy for Modernizing the Regulatory System for Biotechnology Products, which identifies future steps that should be taken to ensure the regulatory system addresses novel types of products appropriately. 2 These documents were to demonstrate that these federal agencies had a sustained commitment to ensuring the safety of future biotechnology products, increasing public confidence in the regulatory system, and preventing unnecessary barriers to future innovation and competitiveness.
The Coordinated Framework clarifies and specifies the role of the three agencies:
The EPA is responsible for protecting human health and the environment. Under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), EPA regulates pesticides. Under section 408 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), EPA establishes the amount of pesticide chemical residues that may be present in food. Under the Toxic Substances Control Act (TSCA) and regulations implementing that statute, EPA currently regulates biotechnology products that are new organisms not specifically excluded by the statute (generally those regulated by other statutes).
3
“FDA regulates a wide variety of products, including human and animal foods (including dietary supplements), cosmetics, human and veterinary drugs, human biological products, and medical devices. FDA regulates the safety of human and animal foods derived from genetically engineered plants. Also, FDA regulates genetically engineered animals under the new animal drug provisions of the FD&C Act and FDA's implementing regulations.” 4
Finally, the USDA Animal and Plant Health Inspection Service (APHIS) is responsible for protecting agriculture from pests and diseases. Under the Animal Health Protection Act (AHPA) and the Plant Protection Act (PPA), the agency regulates products of biotechnology that may pose a risk to agricultural plant and animal health. 5 Further, the Food Safety and Inspection Service (FSIS) is the public health agency in USDA that is responsible for ensuring that the United States' commercial supply of meat, poultry, egg products, and fish of the Order Siluriformes is safe, wholesome, and correctly labeled. Under the Federal Meat Inspection Act (FMIA), Poultry Products Inspection Act (PPIA), and Egg Products Inspection Act (EPIA), FSIS inspects all meat, poultry, and processed egg products in interstate commerce. 6
A main goal for the Coordinated Framework was to modernize the regulatory system for biotech products:
Each of the primary Federal regulatory agencies with jurisdiction over the products of biotechnology has developed regulations and guidance documents to implement its authority under existing laws, resulting in a complex system for assessing and managing potential health and environmental risks posed by the products of biotechnology. While the current regulatory system for the products of biotechnology effectively protects health and the environment, in some cases unnecessary costs and burdens associated with uncertainty about agency jurisdiction, lack of predictability of timeframes for review, and other processes have arisen. These costs and burdens have limited the ability of technology developers, particularly those in small and midsized companies and in academic research institutions, to navigate the regulatory process and have limited the ability of the public to understand easily how the safety of these products is assured. Accordingly, the costs and burdens have the potential to hamper economic growth, innovation, and competitiveness.
7
On the heels of the 2017 Update, and just before Inauguration Day, several guidances and rules were issued. On January 18, 2017, FDA issued a draft guidance on the Regulation of Mosquito-Related Products. 8 Some confusion over the regulation of genetically engineered mosquitos has existed because FDA regulates sterilization and control of animal populations. The draft guidance explains that technologies that reduce mosquito populations should be considered pesticides and thus under the purview of EPA. Last year, it was FDA that took the lead in evaluating Oxitec Ltd.'s environmental review for its mosquitos (OX513A), genetically engineered to spread a lethal gene and cut down mosquito populations.
Also on January 18, FDA released another draft guidance on the Regulation of Intentionally Altered Genomic DNA in Animals, 9 intended to clarify FDA's approach to animals whose genomes have been intentionally altered using modern molecular technologies, such as the use of “nucleases” or “genome editing technologies” including engineered nuclease/nucleotide complexes, such as zinc finger nucleases (ZFN), transcription activator-like effector nucleases (TALEN), and the clustered regulatory interspersed short palindromic repeats (CRISPR) associated systems. The guidance appears quite broad in scope, but we will have to see how it plays out.
Finally, on January 19, 2017, USDA's APHIS issued a proposed rule, Importation, Interstate Movement, and Environmental Release of Certain Genetically Engineered Organisms, 10 revising its regulations for certain genetically engineered organisms. APHIS is proposing a regulatory program in which it first assesses genetically engineered organisms to determine if they pose plant pest or noxious weed risks. If the agency finds that a genetically engineered organism does not pose a plant pest or noxious weed risk, then APHIS would not require a permit for the importation, interstate movement, and environmental release (outdoor use) of the genetically engineered organism. However, if APHIS decides, based on risk analysis, that controls on movement are needed, the agency would require a permit and work with the regulated entity to establish appropriate permit conditions to manage identified risks to allow safe movement (i.e., import, interstate movement, or environmental release [regulated controlled outdoor use such as in field trials]).
The New Administration
As noted above, the 2017 Update to the Coordinated Framework for the Regulation of Biotechnology and the draft guidances and proposed rule were put out by the Obama administration in January. What the Trump administration will do to promulgate or undermine these guidance documents is unknown.
What is known is that on January 20, 2017, White House Chief of Staff Reince Priebus sent a memorandum to the heads of executive departments and agencies, Regulatory Freeze Pending Review, 11 ordering that new regulations must be reviewed by someone appointed or designated by the President. Also, regulations that have been published in the Federal Register but that have not taken effect must be postponed by 60 days, and regulations that have not been published in the Federal Register should be withdrawn. This memo was followed up by a memorandum from the White House on implementation. 12
In addition, on January 23, 2017, the President ordered a hiring freeze of federal civilian employees. 13 Further, the Office of Management and Budget and the Office of Personnel Management issued a guidance document to clarify the hiring freeze.
The White House issued an Executive Order 14 on January 30, 2017 to reduce regulation and control regulatory costs, directing federal agencies to eliminate two regulations for each new one they propose. The Executive Order imposed a zero cost of all new regulations for fiscal 2017. The White House followed up with an Interim Guidance 15 regarding implementation of the Order.
Furthermore, while it was not publicized in an order or memorandum, the new administration also imposed a freeze on EPA grants and contracts. This goes much further than a hiring freeze, and could affect EPA's core operations. 16 Apparently, within hours of President Trump's swearing in, an e-mail went out to the EPA's Office of Acquisition Management. Internal e-mails reflect this freeze: “Right now we are in a holding pattern. The new EPA administration has asked that all contract and grant awards be temporarily suspended, effective immediately. Until we receive further clarification, this includes task orders and work assignments.” 17
Finally, the new administration is requiring that political appointees review current EPA content on the EPA website, and new work by EPA scientists is on a “temporary hold” before it can be released. It is not yet known what will happen to sections of the EPA website dealing with climate change, which the President infamously called a Chinese hoax.
Cutting down funding to federal agencies like FDA and EPA will have an effect on the safety of Americans. Fewer regulations and fewer governmental costs sounds good in a vacuum, but food and health safety are core functions of agencies like these. Still, it was heartening to learn that food safety and drugs were not included in the hiring freeze of federal civilian employees.
We have yet to learn the President's views on R&D and science, though his tweets regarding climate change are disturbing. Similarly, it is not yet known what his influence on the budget for the National Institutes of Health (NIH) will be, or who his science advisors will be. And the full scope of the President's backtracking on President Obama's rules has yet to play out. It appears we are in for a rocky ride!