Overview
Title
An Act To prohibit contracting with certain biotechnology providers, and for other purposes.
ELI5 AI
The BIOSECURE Act, or H.R. 8333, is a rule that wants to stop the U.S. government from buying science stuff from companies that might be dangerous, and it also sets up ways to decide which companies are risky.
Summary AI
H.R. 8333, known as the “BIOSECURE Act,” aims to prevent U.S. government contracts with certain biotechnology companies considered a security concern. It prohibits U.S. executive agencies from buying biotechnology equipment or services from these companies or engaging in contracts with entities using such equipment. The bill outlines conditions under which waivers can be granted, identifies criteria for designating biotechnology companies of concern, and requires a national security risk assessment related to human multiomic data collected by foreign adversaries.
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AnalysisAI
General Summary of the Bill
H.R. 8333, known as the "BIOSECURE Act," aims to prevent U.S. government agencies from entering into contracts or engaging with certain biotechnology providers deemed a threat to national security. It proposes barring these agencies from purchasing or working with biotechnology services from companies identified as "biotechnology companies of concern." The act not only outlines prohibitions but also details circumstances where exceptions and waivers may apply, and sets in place mechanisms for the evaluation and identification of these companies. Moreover, the bill mandates periodic reporting and assessment to safeguard against foreign adversaries acquiring sensitive American multiomic data.
Summary of Significant Issues
The bill raises several significant concerns:
Criteria for Designating Companies: The act lacks clear criteria for classifying "biotechnology companies of concern," which poses a risk of arbitrary designation and potential legal complications.
Waiver Authority: Executive agencies are granted waiver authority to bypass prohibitions if deemed necessary for national security. However, this lacks detailed oversight, creating ethical and political risks.
Ambiguous Terms: Phrases like "the interest of the United States" in the context of providing exceptions for overseas health services could lead to inconsistent interpretations and applications.
Funding Concerns: The act stipulates no additional funding for implementing its measures, which may stretch resources thin and impede effective execution.
Potential Delays: The process of updating the list of concerning companies could encounter delays, challenging timely enforcement of the act's provisions.
Public Impact
The bill has the potential to enhance national security by limiting the influence and reach of foreign biotechnology entities that could misuse sensitive data. By restricting the use of foreign technology, it aims to protect American citizens' multiomic data more effectively.
However, its execution could lead to complications if the absence of specific criteria for designating concerning companies results in disputes or legal battles. Without additional funding, agencies may struggle to meet the reporting and oversight demands, potentially reducing the effectiveness of the act.
Impact on Stakeholders
Government Agencies: While this act could strengthen national security efforts, government agencies face increased pressure with additional responsibilities and no extra funding. They may need to adjust priorities to comply with the new mandates.
Biotechnology Companies: Foreign biotechnology firms could be negatively impacted, particularly if they are placed on the list of concerning companies without transparent criteria. This could limit their market access and strain diplomatic relations.
U.S. Healthcare Providers: There could be impacts on healthcare providers, especially those relying on foreign biotechnology equipment or services, who may need to seek alternative suppliers or navigate exemptions.
General Public: For the American public, the act's focus on protecting private data is likely positive. However, insufficient oversight and potential misuse of waivers might lead to inconsistent security outcomes.
The BIOSECURE Act endeavors to safeguard sensitive data and maintain national security, but it introduces challenges regarding its implementation and potential impacts on various stakeholders. Balancing security with transparency and efficient governance remains crucial for its success.
Issues
The lack of clear criteria for determining 'biotechnology companies of concern' as mentioned in Section 2, subsection (f)(2)(B)(iii), could lead to arbitrary designations and legal challenges.
The waiver authority granted to executive agencies in Section 2, subsection (d), allowing bypassing of prohibitions for 'national security interests' without clear oversight, poses substantial ethical and political risks.
The ambiguity in the term 'the interest of the United States' regarding overseas health care services in Section 2, subsection (d)(2)(A)(ii), could be exploited, leading to inconsistent application and potential ethical concerns.
Section 2, subsection (j) indicates no additional funds are allocated for reporting and evaluation, which may financially strain agencies or undermine the bill's effectiveness.
Provisions in Section 2, subsections (f)(3) to (f)(5), introduce potential delays or inconsistencies in updating the list of biotechnology companies of concern, affecting timely enforcement and security measures.
The bill's language regarding national security risks, particularly in Section 2, subsection (f)(2)(B)(iii), is too open-ended, potentially leading to overreach or misuse of power when interpreting 'affiliated with' or 'poses a risk'.
The reporting requirements to congressional committees post-waiver approval as outlined in Section 2, subsection (d)(1)(A)(ii), might lead to reactive rather than proactive oversight, which may dull legislative efficacy.
Section 2, subsection (h), lacks a specified timeline for implementing the Federal Acquisition Regulatory Council's required regulations, which could delay enforcement and compliance, affecting national security.
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 section prohibits U.S. government agencies from buying or using biotechnology products or services from certain foreign companies that might threaten national security. It also details exceptions, allows waivers in specific situations, defines key terms, and outlines the process for identifying and updating these "biotechnology companies of concern."