Modified Organisms Subject to the Plant Protection Act

The Center for Food Safety (CFS) argues that APHIS should move away from "genetic materiality" as a basis for regulation and instead focus on the specific traits and magnitude of changes produced by genetic engineering. They advocate for a new regulatory regime that covers all GE organisms, requires permits for field trials, and enforces strict gene containment to protect U.S. agriculture and trade.

Ginkgo Bioworks, a cell and protein engineering company, supports a shift toward a science-based, product-focused regulatory framework for modified organisms. They argue that the current process-based system under 7 CFR Part 340 creates excessive costs and delays, and they recommend deregulating non-food GM crops and aligning the regulation of GE organisms with those of conventionally bred organisms.

The Biological Products Industry Alliance (BPIA), representing over 180 member companies, supports the USDA's request for information to modernize the regulatory framework for modified organisms. They argue for a science-based, risk-proportionate pathway that provides clear commercialization endpoints and reduces duplicative oversight for microbial products.

The Innovative Genomics Institute, a public academic research institute, supports a regulatory framework for modified organisms that is based on specific traits and risks rather than the process of genetic engineering. They argue that because genome editing often results in changes indistinguishable from natural mutations, regulations should focus on evidence-based risk assessments to reduce unnecessary regulatory burdens.

Battelle Memorial Institute, which operates the Pacific Northwest National Laboratory, argues that the current regulatory distinction between conventional and genetically engineered organisms is unnecessary for laboratory-based research. They advocate for a streamlined regulatory framework that either eliminates this distinction for R&D work or provides an exemption for laboratory settings where existing controls are already sufficient.

The Agriculture Biotechnology Alliance (ABA), representing producers and biotechnology developers, supports the USDA's interest in modernizing and deregulating the oversight of modified organisms. They argue for a risk-proportionate, science-based regulatory framework that focuses on the product rather than the process to ensure American farmers remain competitive and have access to innovative biological solutions.

The Microbial Biotechnology Policy Committee (MBPC), a task force of companies developing microbial products, supports APHIS's efforts to modernize the regulatory framework for genetically engineered (GE) organisms. They argue for a risk-based, science-driven approach that reduces regulatory barriers, eliminates redundancies between agencies, and provides a predictable pathway for commercializing innovative microbial products.

Living Carbon, PBC, a company developing gene-edited woody crops, supports the USDA's effort to modernize oversight and move toward a risk-based, "product-not-process" regulatory framework. They specifically advocate for a neutral regulatory approach that accounts for polyploids and vegetatively propagated perennials, ensuring they are not unfairly burdened compared to row crops.

The American Alliance for Biomanufacturing (AAB), a coalition of biomanufacturing industry leaders, supports the USDA's efforts to modernize the regulatory framework for modified organisms. They argue for a science-based, risk-focused approach that ensures regulatory predictability, interagency coordination, and efficient pathways to commercialize biotechnology for national economic and security benefits.

The Agriculture and Food Systems Institute (AFSI) supports the USDA's initiative to address the regulatory framework for modified organisms, specifically advocating for a risk-proportionate, product-based approach. They argue that current regulations (7 CFR Part 340) are ill-suited for microorganisms and recommend adopting a tiered structure similar to the SECURE rule to reduce burdens on small entities and researchers.