Identifying Ambiguities,Gaps,Inefficiencies,and Uncertainties in the Coordinated Framework for the Regulation of Biotechnology

Abstract

Editor's Note

In December 2022, the White House Office Science Technology Policy (OSTP) invited public input on improving biotechnology regulation clarity and efficiency as part of The National Biotech and Biomanufacturing Initiative (NBBI).

The Request for Information (RFI) was made on behalf of the primary agencies that regulate the products of biotechnology, the U.S. Environmental Protection Agency (EPA), the Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA)—requests relevant data and information, including case studies, that may assist in identifying any regulatory ambiguities, gaps, inefficiencies, or uncertainties in the Coordinated Framework for the Regulation of Biotechnology, particularly with regard to new and emerging biotechnology products.

The information provided will inform regulatory agency efforts to improve the clarity and efficiency of the regulatory processes for biotechnology products.

Responses to the RFI are intended to aid government in planning and strategy development on executing The President's recent Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy. The following was taken from public comments submitted by the Alternative Fuels & Chemicals Coalition in response to this RFI.

Alternative Fuels & Chemicals Coalition Response to OSTP AFI

AFCC and its member companies are responding to the Federal Register from the White House, Office of Science and Technology Policy (OSTP), Vol. 87, No. 243, Tuesday, December 20, 2022 Notices, entitled, Request for Information; Identifying Ambiguities, Gaps, Inefficiencies, and Uncertainties in the Coordinated Framework for the Regulation of Biotechnology. AFCC and its member companies welcome the Executive Order, E0 14081 on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy, and applaud the administration for its leadership in advancing biotechnology processes and its products.

OSTP Request: Describe Any Ambiguities, Gaps, Inefficiencies, or Uncertainties Regarding Statutory Authorities and/or Agency Roles, Responsibilities, or Processes for Different Biotechnology Product Types, Particularly for Product Types Within the Responsibility of Multiple Agencies

The Coordinated Framework has seen improvements since its conception and continues to have inadequate efficiency in promoting innovation and regulatory cost, and time to market. AFCC and its member companies support regulating the product vs the process, but require the federal agencies work on minimizing regulatory oversight on the same product, and by another federal agency.

Eliminate overly burdensome or duplicative regulatory requirements to advance the commercial introduction of bio-based products. Corrective actions in the area of TSCA, FDA and USDA/APHIS should be considered, including the establishment of a single coordinating agency to streamline regulatory clearance approval requirements.

As an example, EPA inappropriately assumes that other regulatory frameworks are not sufficient to protect human health or the environment (example: Clean Air Act and Clean Water Act).

EPA should rely on its authority and funding mechanisms under these regulations to address these risks rather than imposing greater fees under the TSCA program to ensure these regulations are sufficient to protect human health and the environment.

To avoid duplicative regulatory oversight, EPA should consult with OHSA on PPE requirements and non-compliance. OSHA has ample data and regulatory compliance directions that are backed by statistical evidence.

EPA has over implemented TSCA beyond what was expected post LCSA. EPA has said that “the costs baseline chosen for the 2018 rule was what the Agency spent on implementing TSCA before it was amended in 2016, not what it would cost the Agency to implement it in the manner envisioned and directed by Congress.” However, EPA is going beyond implementation in the manner envisioned and directed by Congress, and EPA should not increase fees and charge industry for the Agency's overzealous implementation.

SCIENCE-BASED RISK ADJUSTED REGULATIONS AND STREAMLINED REGULATORY PROCESSES. CLEARER ROLE DELINEATION/ELIMINATION OF OVERLAP BETWEEN FDA, EPA, AND USDA/APHIS:

Dual oversight must be eliminated. Examples include:

Cell-cultured meat (FDA/USDA)

USDA food safety involvement in the food processing steps after meat cell culture is an artefact as it is modeled after their current post-slaughter oversight in whole animal meat processing. However, food safety issues post cell culture harvest are vastly different from those post animal slaughter and would be better handled by FDA. Moreover, USDA involvement is redundant as it is apparently not required for cell-cultured seafood even though the same safety considerations are in play.

Enzymes/yeast used in ethanol fermentation (EPA/FDA-CVM)

Canada got this one right, with CFIA acknowledging DSL listing as sufficient safeguard for residual enzymes in distillers grains.

For biomanufactured substances/materials: a reform of or adjustment to the Lautenberg Act is essential:

Pre-manufacture notifications (PMNs)

EPA is exhaustively reviewing PMNs with a mindset that every chemical in question is unsafe unless proven safe, resulting in EPA asking redundant and/or scientifically inappropriate questions about every PMN submitted, resulting in serious delays (PMNs now take 1-2 years instead of 90 days) and the need for EPA to raise fees (now proposed to go up to $45,000 from $5,000 pre-Lautenberg).

Single-entry point

A single-entry point for regulatory dossiers would be particularly helpful. For example, the use of an ombudsman or review group to pre-review a simple 2-page description of the biomanufactured substance/material and intended use:

define whether the substance/material is low-risk or high-risk, and

direct the applicant to the right agency

OSTP Request: Describe the Impact, Including Economic Impact, of These Ambiguities, Gaps, Inefficiencies or Uncertainties

PLANT-BASED REGULATIONS

AFCC members source raw materials from the U.S. agricultural and in turn we market our products into global supply chains. We benefit from the access to crop innovation and recognize that these crops often come with compliance requirements up and down our supply chains. We appreciate the efforts by the EPA, FDA and USDA to provide for more timely and predictable regulatory actions regarding applications for approval of new biotechnology-enhanced traits through the Coordinated Framework.

However, within the current regulatory system for genetically engineered products there is still an uncertainty on agency jurisdictions, lack of predictability on timeframe for approval, and lack of transparency. For example, the Sustainable, Ecological, Consistent, Uniform, Responsible, Efficient (SECURE) Rule provides for certain exemptions as it relates to products genetically engineered via gene editing. While science- and risk-based, these exemptions hinder transparency over what is being developed and introduced into the marketplace. With the reduced visibility and transparency for new products produced through genetic engineering (e.g., gene editing), it is imperative that a focus on transparency should be addressed with any changes to reinforce and add confidence in the safety and integrity of the entire supply chain. Transparency is important to enable AFCC members' supply chains (in and out) to ensure compliance in both national and international markets.

U.S. regulatory environment must be improved. AFCC and its member companies recommend developing regulations that can provide for a systems approach to make science- and risk-based decisions. The U.S. is out of alignment with regulatory developments in international markets which puts U.S. agriculture at risk of trade disruptions and access to markets when there are asynchronous approvals and oversight between the U.S. and its key international markets. The U.S. should seek opportunities to engage with international counterparts to seek harmonization in regulation of products produced with genetic engineering. There is also a risk of falling behind other countries in R&D and commercialization. APHIS must implement its regulatory reviews in a way that translates into access for small and medium sized organizations by establishing streamlined regulatory approaches that matches oversight with risk. This would encourage innovation in a broad range of crops.

USDA should provide funding to support critically needed research and development (R&D) in plant breeding, plant-based proteins platform development and should provide funding for not only early-stage R&D projects but also fund scale-up activities through grant programs.

MICROBIAL CONVERSION TECHNOLOGIES

Microbial technologies provide sustainable products and solutions for U.S. agriculture that are based on genetically engineered microbial technologies, and a lot of focus have been provided on biotechnologies that are related to plants.

Much less effort in regulations have been paid to genetically engineered microbial technologies. Technology developers use genetic engineering tools to create high-performing agricultural inputs for crop protection for soil fertility and products to provide sustainable solutions for U.S. growers. These sustainable solutions are aimed to address the impacts of climate change on agriculture as well as to reduce the use of energy consuming synthetic inputs and pesticides.

Therefore, while regulations for genetically engineered plants have been recently revised under 7 CFR part three hundred and forty, the current regulations do not enable predictable path to commercialize and test genetically engineered microorganisms in the agricultural field situations, or bringing them to the marketplace effectively for commercial use. As a result, the developers and industry focused on genetically engineered microorganisms are hindered from effectively and efficiently testing and commercializing sustainable and effective technology for U.S. agriculture. This inhibits the speed at which the technology developers can identify, test, and bring these needed new technologies to market.

Genetically engineered microbial technology developers require the agencies clarify the regulatory framework through the guidance for rulemaking to address the current lack of clarity in the current regulations. Navigating regulations across the three agencies under the Coordinated Framework for Regulation of Biotechnology is a challenge, costly, and very slow, increasing the time to market.

AFCC and its member companies strongly encourage the agencies and our colleagues in the agencies of the coordinated framework to establish a single point of entry for the developers to use to determine how genetically engineered microorganisms for agricultural applications will be regulated. Furthermore, we encourage improved harmonization of existing regulations across USDA/APHIS, FDA, and EPA to provide clarity and effective paths for developers of such technologies, and efficiency and speed to bring such products into the toolboxes for U.S. growers, producers, and U.S. agriculture.

OSTP Request: Describe Any Specific Topics the Agencies Should Address in Plain Language on the Regulatory Roles, Responsibilities, and Processes of the Agencies

BIOBASED PRODUCTS PROCUREMENT

NAICS codes

The 2018 Farm Bill directs the Secretary of Agriculture and the Secretary of Commerce to jointly develop NAICS codes for renewable chemicals and biobased products manufacturers. The next Farm Bill needs to have the NAICS codes directive with a timeline for its implementation by OMB.

NAICS codes would greatly enhance the ability to track and report on the renewable chemicals and biobased products industry, determine the funding requirements from federal and state governments, track innovative activities in the sector, mitigate climate change, and capture the jobs created. Currently, production of renewable chemicals and biobased products have no tracking system, and the industrial biotechnology sector has no knowledge of its growth potential.

BioPreferred^® Program

AFCC and its member companies welcome the Executive Order, E0 14081 on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy, specifically Sec. 6. The Biotechnology Coordinated Framework focused in Sec.8, is setup for multiple federal agencies, FDA, USDA/APHIS, and EPA, and thus, the BioPreferred^® Program is an excellent opportunity to be incorporated in the Coordinated Framework, ensuring these federal agencies to take leadership and purchase biobased products, as stated in Section 9002, Biomarkets Program, in the Farm Bill since its inception in 2002, Energy Title IX – which states all federal agencies and their contractors will purchase biobased products preferably over incumbent technologies as long as they are comparable in price and performance. AFCC and its member companies urge the three agencies to incorporate the measure in the Biotechnology Coordinated Framework.

Biobased Products Procurement

Biobased products procurement in the EO is a step in the right direction. Although, AFCC and its member companies are expressing concerns with the Executive Order 14081, since it has a very narrow window of improving the procurement by federal agencies for biobased products by 2024 – by the time the staff are trained (within two years), the next administration may choose to eliminate the Executive Order 14081, and as such, we request the concepts described in the Executive Order in Sec. 6., Biobased Products Procurement for all federal agencies and their staff be incorporated in the re-authorization of the 2023 Farm Bill as provisions. Sec. 6 of the Executive Order provides guidelines to all federal agencies and the intent of Congress in the creation of Section 9002, Biomarkets Program in Energy Title IX of the Farm Bill. This needs to be in legislation since the federal agencies have not been given direction in the implementation of the Biomarkets Program since its inception in the 2002 Farm Bill.

There are changes requested in the implementation of the BioPreferred^® Program, while encouraging the purchasing program of sustainable products, it is not operating the way Congress intended. Without sound sales numbers and procurement officers identified for the program the supply chain for renewable chemicals and biobased products will continue to be broken. If the program were operating properly, it would be very successful. AFCC and its member companies welcome quarterly updates from USDA and other federal agencies to Congress and/or OMB for the procurement of renewable chemicals and biobased products, and furthermore written as a measure in the 2023 Farm Bill.

The BioPreferred^® Program needs the label or certification to be modernized, showing that the renewable chemicals and biobased products are indeed sustainably sourced. Currently, the label shows a carbon content which is based on beginning of life, there is no end of life – the sustainability piece is missing on the label. Therefore, at a time of increased pressures on retailers, brands and manufacturers to reduce the carbon footprint of their consumer products, the label needs to show a carbon intensity (CI) score which will be determined by an international American Standard Test Method (ASTM).

Today, the biobased products are being denied shelf space in large retailers' shelves such as Amazon, Office Depot, Staples, and other distributors, because the products are not considered more sustainable or economically viable. AFCC is working with ASTM on developing the CI score for biobased consumer products based on sound science and regenerative agriculture practices. Modernizing the BioPreferred^® label with the carbon intensity seal will give consumer confidence for the sustainable production and for the first time will give the USDA BioPreferred^® Program the opportunity to contribute towards a measurable net-zero emissions by 2050. Making a real transition to a Bioeconomy future will require making a change to the status quo for all products.

Greenhouse Gases, Regulated Emissions, and Energy Used in Transportation (GREET)

AFCC and its member companies urge EPA to update their modeling used for lifecycle greenhouse gas assessments for corn-based ethanol, sustainable aviation fuels, renewable chemicals, biobased products, and for other purposes. EPA should use GREET model or the “gold standard” developed by Argonne National Laboratory. Use of outdated modeling tools gives incorrect data, especially with newer climate smart practices such as regenerative agriculture.

The Federal Trade Commission (FTC) and Life Cycle Assessment (LCA)

The Federal Trade Commission (FTC) should not be providing guidelines for Life Cycle Assessment (LCA). AFCC and its member companies strongly recommend that third party review of LCAs should be allowed per ISO 14067 to address FTC guidelines. We have already committed to Internal Revenue Service (IRS) as proposed in statute, the use of LCAs for several initiatives, some of which are tax incentives such as Section 45Q, carbon capture sequestration, and other tax incentives in the most recent legislation, Inflation Reduction Act of 2022.

Conclusion

AFCC and its member company's welcome conversations with the White House, Office of Science Technology Policy, regarding improving the time to commercial success and delivering on the promise of Biomanufacturing.