Overview
Title
An Act To prohibit contracting with certain biotechnology providers, and for other purposes.
ELI5 AI
The BIOSECURE Act (H.R. 8333) is like a rule saying the U.S. government shouldn't make deals with certain overseas biology companies that could be unsafe, but it lets them help in emergencies or overseas health and spy stuff.
Summary AI
H.R. 8333, also known as the "BIOSECURE Act," aims to prevent U.S. government agencies from contracting with certain biotechnology companies deemed as threats to national security. It lists specific firms like BGI and WuXi AppTec and outlines criteria for identifying other concerning companies, particularly those tied to foreign adversaries. The bill provides exceptions for necessary overseas health services and intelligence activities, and includes provisions for evaluating risks related to the misuse of biotechnology and personal data. Additionally, the bill mandates regular reporting and regulatory updates to ensure compliance without requiring additional funding.
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AnalysisAI
The U.S. House of Representatives recently passed H.R. 8333, also known as the BIOSECURE Act, which aims to enhance national security by restricting governmental procurement from select biotechnology companies considered to be of concern, particularly those associated with foreign adversaries. The law intends to eliminate national security risks tied to information and data obtained through biotechnological services and equipment from these entities.
General Summary of the Bill
The BIOSECURE Act seeks to prohibit U.S. executive agencies from engaging in contracts with certain biotechnology providers. It outlines specific criteria for identifying "biotechnology companies of concern," primarily focusing on entities associated with or influenced by foreign governments that could pose security risks. Additionally, the bill establishes exceptions and waivers under circumstances that involve national security interests and overseas health care services. It assigns responsibilities to various government bodies, such as the Federal Acquisition Regulatory Council, to implement regulations aligned with this policy. The legislation also details procedures for assessing and managing national security threats linked with the acquisition of sensitive biotechnological data.
Summary of Significant Issues
Several issues emerge from this bill that warrant consideration. Firstly, the strict prohibition against contracting with certain biotechnology providers might restrict options available to government agencies, potentially hindering responsiveness in emergency situations where specific biotechnological resources are critical. The broad or vague criteria for designating entities as biotechnology companies of concern may lead to subjective or unfair classifications. Moreover, while the bill provides notice for companies to oppose their designation, it lacks clear guidelines for appealing such decisions, which could lead to disputes and challenges.
The waiver process detailed in the bill is potentially cumbersome, requiring approval from both the Director of the Office of Management and Budget and coordination with the Secretary of Defense, possibly delaying urgent acquisitions. Finally, the legislation mandates several regulations and assessments without explicitly allocating additional funds for enforcement, which might impede its effective implementation.
Impact on the Public
Broadly, the BIOSECURE Act could enhance national security by aiming to block potential threats stemming from foreign manipulation or misuse of American biotechnology. This measure reflects growing concerns about the safety of multiomic data—which includes detailed genetic and biological information—and the necessity to safeguard it against foreign adversaries.
Impact on Stakeholders
From a stakeholder perspective, entities identified as biotechnology companies of concern stand to face significant business disruptions. This could lead to losses in government contracts and may impact their operations and profitability. For government agencies, the restrictions may mean limited access to innovative biotechnological products critical in health and national security domains, potentially affecting service delivery and capability.
For American citizens, particularly those involved in health and scientific research, the act aims to provide enhanced data security concerning their personal and sensitive information. However, the broad definitions used might inadvertently affect wider segments of the biotech industry, including potentially limiting American competitiveness or innovation in the global biotechnology sector.
In conclusion, while the BIOSECURE Act sets out to strengthen national security, it raises concerns about flexibility and fairness that might need addressing to ensure it does not inadvertently disadvantage key stakeholders or compromise scientific progress.
Issues
The prohibition on contracting with certain biotechnology providers (Section 2) could limit available options for executive agencies and might not provide enough flexibility for responding to emergencies or unforeseen situations.
The criteria for designating a 'biotechnology company of concern' in Section 2(f) are broad or vague, describing entities that pose a 'risk to national security of the United States', which might lead to unfair classifications.
Section 2(f)(5) provides notice and opportunity for companies to oppose their designation as biotechnology companies of concern, but there is no clear provision for appealing or contesting such designations, potentially leading to disputes.
The waiver process in Section 2(d) could be burdensome and cause delays due to the requirement for approvals from both the Director of the Office of Management and Budget and coordination with the Secretary of Defense.
Though the bill in Section 2(j) prohibits certain activities, it does not allocate funds for its implementation, potentially limiting effective enforcement.
The term 'biotechnology equipment or service' (Section 2(k)(2)) is broad, potentially affecting a larger portion of the market than intended.
Section 2(h) requires the Federal Acquisition Regulatory Council to update regulations without specifying a timeline, risking delays in implementation.
The descriptions of foreign adversaries rely on definitions from other statutes (Section 2(k)(6)), which may lead to inconsistencies if those definitions are updated or changed.
Sections
Sections are presented as they are annotated in the original legislative text. Any missing headers, numbers, or non-consecutive order is due to the original text.
1. Short title Read Opens in new tab
Summary AI
The BIOSECURE Act is the name that may be used to refer to this law.
2. Prohibition on contracting with certain biotechnology providers Read Opens in new tab
Summary AI
The bill section prohibits executive agencies from contracting with certain biotechnology providers, especially those associated with foreign adversaries, to reduce national security risks. It also outlines exceptions, waiver conditions, and defines key terms like biotechnology equipment and foreign adversary.