In the USA, biotechnology is managed through a system of regulations which translate broad Congressional laws into enforceable, specific rules. These rules are established through a rule-making process that can include an opportunity for public comment. Rule-makers must in turn respond to each comment and explain why they are or are not incorporated into the final rule.

Said another way, the public can really influence what regulation covers. Historically, scientists and science organizations have been reluctant to get involved in the rule-making process. Anti-science groups of various types, however, had no such qualms. The overly prohibitive regulations that governed biotechnology from 1980-2020 reflected the lack of scientific participation in rule-making.

Over the past years, the SIVB has responded to requests for public comment from both USDA and FDA, and numerous recommendations from SIVB were incorporated in the USDA’s SECURE rule until it got vacated by a judge.

Most recently, the USDA issued a “Request for Information on Modified Organisms Subject to the Plant Protection Act” basically asking which GMOs should be considered to be a plant pest, as being a plant pest invokes the right and duty of USDA to regulate them. Whereas many writers advocated treating anything GM like a plant pest, SIVB expanded more on the scientific basis and methods whereby an organism may or may not be a plant pest. The SIVB comments are posted at https://downloads.regulations.gov/USDA-2026-0133-1837/attachment_1.pdf

Since a substantial membership of SIVB is academic, issues that affect academics are also the purview of the Public Policy committee. The Office of Management and Budget recently issued a series of proposed regulations that would govern financial aid from the US government, including individual research grants to scientists and meeting grants to SIVB. The proposed changes leave the ultimate approval of grant monies at the whims and discretion of government bureaucrats, and even if awarded, contain provisions that could greatly limit the ability to use grant funds for travel to meetings such as SIVB. It would also limit international collaborations and open-access publishing. The Public Policy committee prepared comments and submitted these for SIVB. As of this writing, they have not been posted yet.

Next on the agenda, the USDA has given pre-notice of pending rule making, specifically “To create exemptions from USDA’s regulations for plants and microbes that are already subject to EPA regulation and products USDA previously reviewed and deregulated, and provide a permitting exemption for certain modified organisms that are commonly used in laboratory development of products of biotechnology.” Anyone interested in assisting the committee prepare its comments is welcome! Just let Michele know!