Text of Senate Amendment 6666

On 2026-07-13, Senator Todd Young (R-IN) delivered a floor speech titled "Text Of Senate Amendment 6666" in the Senate.

Text of Senate Amendment 6666

Congressional Record, Volume 172 Issue 113 (Monday, July 13, 2026) [Congressional Record Volume 172, Number 113 (Monday, July 13, 2026)] [Senate] [Pages S3900-S3903] From the Congressional Record Online through the Government Publishing Office [ www.gpo.gov ] SA 6666. Mr. YOUNG (for himself, Mr. Padilla, Mr. Cotton, Ms. Klobuchar, Mr. Fetterman, and Mr. Budd) submitted an amendment intended to be proposed by him to the bill S. 4784, to authorize appropriations for fiscal year 2027 for military activities of the Department of Defense, for military construction, and for defense activities of the Department of Energy, to prescribe military personnel strengths for such fiscal year, and for other purposes; which was ordered to lie on the table; as follows: At the end, add the following: DIVISION F--AMERICAN BIOTECHNOLOGY COMPETITIVENESS ACT SECTION 1. SHORT TITLE. This division may be cited as the ``American Biotechnology Competitiveness Act''. TITLE I--BIOSECURITY MODERNIZATION AND INNOVATION SEC. 101. DEFINITIONS. In this division: (1) Benchtop nucleic acid synthesizer.--The term ``benchtop nucleic acid synthesizer'' means a device or integrated system that-- (A)(i) is capable of performing de novo synthesis of nucleic acid sequences by an end user at the site of use; or (ii) is capable of performing de novo synthesis of nucleic acid sequences without requiring the end user to submit an order to a separate covered entity to perform such synthesis; and (B) is intended for distribution to, or use by, individual researchers, research institutions, institutional core facilities, or other end users, regardless of the physical dimensions of such device or system. (2) Covered entity.-- (A) In general.--Except as provided in subparagraph (B), the term ``covered entity'' means a person who-- (i) synthesizes and sells synthetic nucleic acids to persons in the United States or in a foreign country; or (ii) produces and distributes or sells, including resellers, equipment for synthesizing nucleic acids, including benchtop nucleic acid synthesizers, to persons in the United States or in a foreign country. (B) Exception.--The term ``covered entity'' does not include a person to the extent the person sells or distributes synthetic nucleic acids within a commercial entity for the purpose of such entity's research and development activities. (3) Director.--The term ``Director'' means the Director of the Office of Science and Technology Policy. (4) Secretary.--The term ``Secretary'' means the Secretary of Commerce. (5) Under secretary.--The term ``Under Secretary'' means the Under Secretary of Commerce for Standards and Technology. SEC. 102. SENSE OF CONGRESS. It is the Sense of Congress that-- (1) the field of biotechnology is accelerating and the United States is at risk of losing its biotechnology leadership to foreign adversaries; (2) this acceleration of the field brings the United States into a period of both great opportunity and risk; (3) policymaking for biosecurity, biosafety, and responsible innovation needs to be flexible to keep pace with advances in the biotechnology and ensure an environment that allows biotechnology research and industry to flourish; (4) the current landscape of biosecurity and biosafety authorities is spread among multiple agencies, contributing to slow policymaking, which, coupled with the rapid advancement of biotechnology, becomes outdated quickly; (5) previous studies conducted by the Government Accountability Office, the National Security Commission for Emerging Biotechnology, and several presidential administrations have already identified gaps in the Federal Government's oversight of biosecurity and biosafety risks; (6) the United States Government needs to streamline biosecurity and biosafety authorities to ensure efficiency and clarity; (7) gene synthesis technology is becoming increasingly sophisticated and accessible, along with the ability to design novel nucleic acid sequences; (8) both of these factors described in paragraph (7) may increase the risk of the development and deployment of new pathogens by bad actors; and (9) gene synthesis screening of orders and customers is immediately needed to mitigate risk in the short-term, which will act as a stopgap while the United States Government develops a comprehensive biosecurity and biosafety strategy that is appropriate for the dynamic and rapidly advancing field of biotechnology. SEC. 103. NUCLEIC ACID SYNTHESIS SECURITY. (a) Regulations Required.-- (1) In general.--Not later than 1 year after the date of the enactment of this Act, the Secretary shall, in consultation with the heads of other agencies as the Secretary considers appropriate, establish and maintain by regulation the following: (A) A requirement for covered entities to implement screening protocols to detect sequence inputs, synthesis instructions, and orders for sequences of concern included in the list established and maintained under subparagraph (C), including sequences generated through benchtop nucleic acid synthesizers. Such protocols shall-- (i) include the ability for privacy-preserving submission of information regarding sequence inputs, synthesis instructions, and orders for potential sequences of concern to a mechanism, which may be maintained by the Secretary or an independent organization designated by the Secretary, for facilitating effective split order detection across covered entities, utilizing the list established and maintained under subparagraph (C); and (ii) prioritize the mitigation of misuse of sequences capable of creating pathogens with pandemic potential. (B) A requirement for covered entities to implement screening protocols to verify the identity and legitimacy of customers. (C) A list of sequences of concern, which shall be determined by the Secretary in consultation with the heads of Federal departments and agencies as the Secretary considers appropriate. (D) A system for reviewing and updating on a regular basis the list of sequences of concern established and maintained under subparagraph (C) that-- (i) uses a docket to allow for privacy-preserving submissions from the public on recommendations for the list of sequences of concern; (ii) includes an expedited procedure to rapidly add sequences of concern to the list on a provisional basis, which may include, as far as technically feasible, automatic procedures such as algorithmic literature scanning, industry self-reporting, or inter-agency submissions; and (iii) incorporates strong data security and confidentiality standards. (E) A conformity assessment system to verify that covered entities are adhering to the requirements established and maintained under subparagraphs (A) and (B), which will include-- (i) an auditing process to ensure sequence inputs, synthesis instructions, orders, and customers have been scrutinized appropriately, including procedures to conduct adversarial testing (sometimes referred to as ``red- teaming'') in accordance with the standards developed under subsection (c)(4), at random intervals to ensure compliance; and (ii) a process to revoke conformity status of covered entities that fail to maintain compliance with the requirements established and maintained under subparagraphs (A) and (B), including the establishment of a grace period for covered entities who have failed auditing or adversarial testing under clause (i) to demonstrate compliance or mitigation steps. (F) A process, administered by an official of the Department of Commerce designated by the Secretary-- (i) to receive findings from testing conducted in accordance with the standards developed under subsection (c)(4), reports of suspicious orders submitted by covered entities, and related tips and referrals from Federal, State, or local authorities; (ii) to determine whether a reported order corresponds to a test order submitted in accordance with the standards developed under subsection (c)(4) and, if so, record the covered entity's identification of the order as evidence of compliance and close the report without referral to any law enforcement agency; and (iii) to act on a valid finding that a covered entity has failed to maintain compliance with a requirement under this paragraph, including by affording the covered entity notice and a grace period as established in subparagraph (E)(ii). (G) Safeguards to ensure regulations promulgated under this subsection avoid unnecessary burden on innovation and industry by-- (i) allowing covered entities to offer an expedited review process for institutional customers, including considering principal investigators at institutions of higher education, with demonstrated records of legitimacy; (ii) providing exemptions from customer screening requirements for sequences or products as determined in clause (iii) that are clearly non-hazardous and pose no credible threat to public health or national security based on scientific literature and industry best practices for biosecurity screening; and (iii) conducting regular consultations with relevant experts to determine exempted sequences and minimize regulatory burden while maintaining security effectiveness. (2) Rules of construction.--Paragraph (1)(A) shall not be construed-- (A) to prohibit a covered entity, as defined in section 101(2)(A)(i), from synthesizing a sequence; or [[Page S3901]] (B) to prohibit a covered entity, as defined in section 101(2)(A)(ii), from producing equipment for synthesizing nucleic acids. (b) Program of Technical Assistance.-- (1) Program required.--The Secretary shall establish a program to provide technical assistance upon request of a covered entity, including assistance with orders whose screening results are ambiguous, subject to determination by the Secretary, in consultation with the heads of such other Federal departments and agencies as the Secretary considers appropriate. (2) Treatment of information received.--Information received as part of the technical assistance request