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HHS Releases Public Communication From Texas Association for Home Care & Hospice
By Jaymar B. Talang
WASHINGTON, March 27 -- The U.S. Department of Health and Human Services has released the following public communication dated March 7, 2025, from the Texas Association for Home Care and Hospice:* * *
To: U.S. Department of Health and Human Services
Office for Civil Rights
Attention: HIPAA Security Rule NPRM
Hubert H. Humphrey Building, Room 509F
200 Independence Avenue SW
Washington, DC 20201
Re: HIPAA Security Rule To Strengthen the Cybersecurity of Electronic Protected Health Information
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Thank you for the opportunity to comment on the HIPAA Security Rule To Strengthen the Cybersecurity ... Show Full Article WASHINGTON, March 27 -- The U.S. Department of Health and Human Services has released the following public communication dated March 7, 2025, from the Texas Association for Home Care and Hospice: * * * To: U.S. Department of Health and Human Services Office for Civil Rights Attention: HIPAA Security Rule NPRM Hubert H. Humphrey Building, Room 509F 200 Independence Avenue SW Washington, DC 20201 Re: HIPAA Security Rule To Strengthen the Cybersecurity of Electronic Protected Health Information * * * Thank you for the opportunity to comment on the HIPAA Security Rule To Strengthen the Cybersecurityof Electronic Protected Health Information Proposed Rule.
The Texas Association for Home Care and Hospice (TAHC&H) represents over 1,200 licensed Home and Community Support Services Agencies (HCSSAs) across the state of Texas. Many of these licensed HCSSAs are Hospice providers. As such, we welcome the opportunity to provide feedback on the HIPAA Security Proposed Rule. Our mission is to advocate for ethical practices, quality, and economic viability of licensed providers in Texas. Our membership, like Texas, is very diverse and includes agencies from rural and urban areas, both large and small. TAHC&H remains committed to working with you to improve the security of protected health information through innovations in efficiency and quality that safeguard patient health records.
On behalf of Texas Hospice Providers, TAHC&H offers the following comments and recommendations:
TAHC&H believes that due to the many cybersecurity threats currently affecting the healthcare industry, more stringent regulations should be implemented to protect electronic medical records. However, we do not believe that a 'one size fits all' rule is a step in the right direction. We do not agree with the SBA's determination that a small business is a business that generates nineteen million dollars or less revenue annually. Many home care agencies in Texas are truly small family-owned or rural businesses that generate under five hundred thousand dollars a year. With consistent increased industry costs, like higher wages for clinician retention due to significant ongoing staffing shortages; unjust recoupments and/or claims denials; increased costs related to infection control; the forced need to hire additional office staff for adherence to ongoing processes like federal, state, and third-party medical reviews; completion and tracking of appeals for federal, state, and third party payer issues; federal and state provider enrollment, revalidation and contracting requirements; and overall inflationary increases in day to day operations, many home care agencies are already faced with financial burdens that present legitimate concerns for their livelihood. With the heavy financial weight of the requirements in this rule and the very limited time frame to comply with the requirements, many of these smaller agencies would be forced to close their doors.
While we agree that smaller and rural home care agencies may not have the same cybersecurity protections currently in place as larger agencies, we must acknowledge the significant financial differences between these types of home care agencies as the primary reason. A small or rural home care agency may have a patient census of twenty-five or under, whereas a large home care agency may have a patient census of one hundred or more. That is a vast difference in the financial capabilities of a home care agency and should be considered in the framework of this proposed rule.
Many home care providers are not educated in the IT industry and would be blind in choosing an IT management company that is qualified to meet full compliance with these requirements. Home care providers cannot assume that vendors are going to take care of everything on their behalf but instead they need to be proactive in asking the right questions and re-evaluating their technological needs where they identify any parts of their technology eco-systems that may fall short. This adds another relevant concern for those whom lack the knowledge and resources to ask the right questions of potential IT vendors. With the limited time frames proposed in this rule for providers to make policy and process revisions, hire additional staff, complete asset inventories, ensure software requirements are met, contract with a knowledgeable IT management company, and meet the other intricate requirements of this proposed rule, there is a significant concern that home care providers will be forced to make rushed, uneducated decisions that don't actually meet the requirements of this proposed rule, which in turn could leave a widened potential for costly mistakes and inadvertent non-compliance.
Currently, electronic health record vendors and patient data hosting vendors offer optional addons, like multi factor authentication to contracted health care providers. With this proposed rule enforcing major upgrades to software systems and IT framework, such as mandatory multi-factor authentication, there is a significant concern that the weight of all healthcare industry providers now being required to have these services could create IT industry-wide backlogs and other issues, such as product support and response time to correct identified system issues. This could potentially defeat the purpose of the IT systemic requirements in this rule if vendor response time to technical issues or other support issues lead to weaknesses within their technology.
We believe that home care providers can implement compliant cybersecurity protections at a lower cost if given additional time to adhere to the provisions in this rule. By having additional time for education, budgeting and compliance, providers can more carefully research affordable and lower cost IT management teams, encryption tools and secure cloud-based platforms, which will be of critical importance for the livelihood of home care agencies who are already struggling with the financial and regulatory pressures of the current industry climate.
Thank you for the opportunity to submit comments and for your consideration of our concerns.
Sincerely,
Jennifer Elder
Director of Regulatory Affairs
Texas Association for Home Care & Hospice
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Original text here: https://downloads.regulations.gov/HHS-OCR-2024-0020-4609/attachment_2.pdf
EPA Releases Public Communication From Clean Air Task Force
By Merly T. Lapig
WASHINGTON, March 27 -- The U.S. Environmental Protection Agency has released the following public communication dated March 13, 2025, from Clean Air Task Force, Boston, Massachusetts:* * *
To: Hon. Lee Zeldin,
Administrator, Environmental Protection Agency
c/o EPA Docket Center
Docket ID No. EPA-HQ-OAR-2024-0419
Mail Code 28221T
1200 Pennsylvania Avenue NW
Washington, DC 20460
Re: Review of New Source Performance Standards for Stationary Combustion Turbines and Stationary Gas Turbines (Docket ID: EPA-HQ-OAR-2024-0419).
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Dear Administrator Zeldin:
Clean Air Task Force, Inc. (CATF) ... Show Full Article WASHINGTON, March 27 -- The U.S. Environmental Protection Agency has released the following public communication dated March 13, 2025, from Clean Air Task Force, Boston, Massachusetts: * * * To: Hon. Lee Zeldin, Administrator, Environmental Protection Agency c/o EPA Docket Center Docket ID No. EPA-HQ-OAR-2024-0419 Mail Code 28221T 1200 Pennsylvania Avenue NW Washington, DC 20460 Re: Review of New Source Performance Standards for Stationary Combustion Turbines and Stationary Gas Turbines (Docket ID: EPA-HQ-OAR-2024-0419). * * * Dear Administrator Zeldin: Clean Air Task Force, Inc. (CATF)respectfully submits these comments on the Environmental Protection Agency's (EPA) proposed rule on the Review of New Source Performance Standards for Stationary Combustion Turbines and Stationary Gas Turbines (Docket ID: EPA-HQ-OAR-2024-0419).1
CATF is a nonprofit organization dedicated to advancing the policy and technology changes necessary to achieve a zero-emissions, high-energy planet at an affordable cost. With more than 25 years of internationally recognized expertise on environmental policy and law, and a commitment to exploring all potential solutions, CATF is a pragmatic, non-ideological advocacy group with the bold ideas needed to address climate change and air pollution. CATF has offices in Boston, Washington, D.C., and Brussels, with staff working remotely around the world.
CATF joins coalition comments advocating for broader application of stringent emissions limits based on use of combustion controls and selective catalytic reduction (SCR). We write separately here to highlight the forward-looking benefits of selective catalytic reduction (SCR) not only for the removal of nitrogen oxides (NOx), but also for use in conjunction with systems for carbon dioxide (CO2) emissions reduction. SCR, which EPA identified as the best system of emission reduction for most gas-fired turbines, provides additional public health benefits when installed on a source that uses amine-based carbon capture systems--the most common technology in use today.2
Installation of SCR improves future options for these plants, and we encourage EPA to acknowledge this ancillary benefit. NOx (particularly NO2) reacts with amine solvents, leading to...
/1 Review of New Source Performance Standards for Stationary Combustion Turbines and Stationary Gas Turbines, 89 Fed. Reg. 101,306 (Dec. 13, 2024).
/2 See Great Plains Institute & Carbon Solutions, Carbon Capture Co-benefits (Aug. 2023), https://carboncaptureready.betterenergy.org/wp-content/uploads/2023/08/Carbon-Capture-Co-Benefits.pdf.
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...increased solvent degradation and potential formation of other non-GHG air pollutants.3 Hydrogen co-firing can also increase NOx emissions.4 In both instances, appropriate pollution controls, and SCR in particular, can mitigate these increases and allow these sources to achieve CO2 reductions without corresponding increases in NOx5 while simultaneously improving capture system performance. Notably, several vendors have developed integrated control systems that include both carbon capture and SCR elements.6
A future carbon emission standard alone is unlikely to fully address the issue. Retrofitting carbon capture on a natural gas-fired combustion turbine or natural gas combined cycle unit may or may not cause air pollution increases sufficient to trigger new source review requirements, and therefore may not require the addition of SCR to a unit to satisfy best available control technology or lowest achievable emission rate requirements.7 But investment in the project could be sufficiently large as to qualify as a reconstruction, making the current turbine NSPS critical for ensuring appropriate controls. EPA noted in its carbon pollution standards for new gas plants that it expected that "most [non-greenhouse gas] pollutants would be mitigated or controlled by equipment needed to meet other [Clean Air Act] requirements."8 But that is so only if the other Clean Air Act requirements are sufficiently up to date to require modern emissions controls. The NSPS for combustion turbines is not currently adequate to the task. CATF therefore urges EPA to base stringent NOx standards on SCR, which is compatible with carbon capture, as the best system of emission reduction when it finalizes the rule.
/3 See Gary T. Rochelle, Air pollution impacts of amine scrubbing for CO2 capture, 11 Carbon Capture Sci. & Tech. 100192 at 12 (2024), https://www.sciencedirect.com/science/article/pii/S2772656824000046.
/4 See Clean Air Task Force, Emissions and Performance Implications of Hydrogen Fuel in Heavy Duty Gas Turbines (June 2023), https://cdn.catf.us/wp-content/uploads/2023/07/13144950/emissions-performance-implicationshydrogen-fuel-heavy-duty-gas-turbines.pdf.
/5 See Sanjay Purswani & Daniel Shawhan, Resources for the Future, How Clean Is Your Capture? Co-Emissions from Planned U.S. Power Plant Carbon Capture Projects, Working Paper 23-29 at 18 (July 2023), available at https://www.rff.org/publications/working-papers/how-clean-is-your-capture-co-emissions-from-planned-us-powerplant-carbon-capture-project/. Other studies suggest that designing retrofits with carbon capture using amine-based solvents can increase ammonia emissions in flue gas as well, which can be controlled with an acid wash section, which is additional to the water wash that is provided as a part of most amine scrubbing processes. See Rochelle, supra note 3 at 2, 5, 11.
/6 See, e.g., Cormetech, CORMETECH and Ozona Partner to Advance Carbon Capture and Sequestration (June 18, 2024), https://www.powermag.com/could-scr-catalyst-technology-adoption-be-a-roadmap-for-power-plants-seekingeconomical-and-efficient-co2-point-source-solutions/; Hugh Barlow & Shahrzad Shahi, State of the Art: CCS Technologies 2024 [Technical Report], Global CCS Institute at 64 (see "Belcro Gas Cleaning" technology), https://www.globalccsinstitute.com/wp-content/uploads/2024/08/Report-CCS-Technologies-Compendium-20243.pdf.
/7 See Environmental Protection Agency, RACT/BACT/LAER Clearinghouse (RBLC) Basic Information, https://www.epa.gov/catc/ractbactlaer-clearinghouse-rblc-basic-information (last visited March 12, 2025).
/8 New Source Performance Standards for Greenhouse Gas Emissions From New, Modified, and Reconstructed Fossil Fuel Electric Generating Units, 89 Fed. Reg. 39,798, 39,936 (May 9, 2024).
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Respectfully submitted,
Alan Masinter, Attorney
Frank Sturges, Attorney
Clean Air Task Force
114 State St., 6th Floor
Boston, Massachusetts 02109
amasinter@catf.us
fsturges@catf.us
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Original text here: https://downloads.regulations.gov/EPA-HQ-OAR-2024-0419-0048/attachment_1.pdf
CDC Releases Public Communication From Radiological Society of North America
By Jaymar B. Talang
WASHINGTON, March 27 -- The U.S. Department of Health and Human Services Centers for Disease Control and Prevention has released the following public communication dated March 17, 2025, from the Radiological Society of North America. Oak Brook, Illinois:* * *
Re: Docket: CDC-2024-0103; NIOSH-355 - Expansion of NIOSH B Reader Eligibility: Request for Information
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The Radiological Society of North America (RSNA) is a non-profit professional association representing over 48,000 medical imaging professionals spanning the full breadth of radiologic subspecialties in more than 150 countries ... Show Full Article WASHINGTON, March 27 -- The U.S. Department of Health and Human Services Centers for Disease Control and Prevention has released the following public communication dated March 17, 2025, from the Radiological Society of North America. Oak Brook, Illinois: * * * Re: Docket: CDC-2024-0103; NIOSH-355 - Expansion of NIOSH B Reader Eligibility: Request for Information * * * The Radiological Society of North America (RSNA) is a non-profit professional association representing over 48,000 medical imaging professionals spanning the full breadth of radiologic subspecialties in more than 150 countriesaround the world. Our mission is to promote excellence in patient care and healthcare delivery through education, research, and technological innovation. RSNA is committed to advancing the field of radiology through continuous education and professional development and offers a comprehensive suite of educational resources designed to support radiologists and medical imaging professionals at every stage of their careers.
RSNA appreciates the opportunity to provide comments in response to the Centers for Disease Control and Prevention (CDC) National Institute for Occupational Safety and Health (NIOSH) Request for Information (RFI) on Expansion of NIOSH B Reader Certification Eligibility (Docket: CDC-2024-0103; NIOSH-355). The NIOSH B Reader program certifies physicians in the ability to classify chest radiographs for pneumoconiosis and is used by the agency in its health surveillance programs for workers whose jobs expose them to mineral dust. In an effort to increase the number of certified B Readers and ensure that such certified readers are available in all U.S. states and territories, NIOSH is considering allowing Nurse Practitioners (NP) and Physician Assistants (PA) to become eligible to become certified B Readers.
As an organization dedicated to maintaining the highest standards in radiologic interpretation and patient care, RSNA recognizes the importance of having a sufficient number of certified B Readers. However, the classification of pneumoconiosis using the International Labour Organization (ILO) system is a highly specialized skill requiring advanced knowledge of chest radiography and occupational lung disease pathology. Radiologists undergo extensive formal training in medical image acquisition and interpretation, including a minimum of four years of residency following medical school, which uniquely equips them to detect and classify complex lung pathologies.
While NPs and PAs play an essential role in patient care and healthcare delivery, their training does not typically include the same depth of radiology education that is essential for accurate and consistent application of the ILO system to chest radiograph classification. Expanding eligibility to practitioners without formal imaging and radiology training could reduce the reliability of pneumoconiosis classifications, which could have medical and legal consequences for affected individuals participating in federal health surveillance programs. As a general principle, RSNA recommends that when non-physician providers (NPP) are involved in medical imaging and radiologic care, these NPPs contribute as part of a radiologist-led team and do not focus on independent image interpretation, which necessitates additional training and expertise in radiology and medical imaging to ensure proper patient care. For example, one aspect of interpreting chest radiographs from workers participating in federal health surveillance programs is the detection and communication of unexpected findings like lung cancer, which these individuals, even when they are nonsmokers, are at greater risk of developing. Failing to detect such findings could have a significant negative impact on patient care and outcomes.
RSNA recognizes the workforce challenges facing NIOSH and understands the agency's concern regarding the availability of certified B Readers, especially in geographic regions currently lacking certified readers. However, rather than expanding B Reader eligibility to non-physicians, we recommend that NIOSH consider initiatives to better promote the B Reader certification program and incentivize more radiologists to become B Readers. Such initiatives might include (1) expanding B Reader certification training opportunities tailored to radiologists; (2) increasing efforts to promote B Reader certification among radiologists, especially those in earlier stages of their careers; and (3) providing financial incentives for participating physicians that allow them to recoup investments made to obtain and maintain certification. NIOSH should target these efforts to those geographic regions currently experiencing an unmet need for B Readers. In addition, NIOSH should explore mechanisms to better match certified B Readers with opportunities to read cases. Many certified B Readers report underutilization, noting that they do not routinely receive cases to read. Furthermore, the current online phone directory is challenging to use and still emphasizes filtering certified B Readers by state, despite the digital nature of radiographic images, making transmission of images from regions lacking certified B Readers accessible for remote reading by certified readers located elsewhere.
RSNA proudly hosts the world's largest and most influential radiology conference each November in Chicago, IL, drawing tens of thousands of radiologists, researchers, and industry leaders from around the globe. This premier event serves as a hub for medical imaging advancements, professional development, and interdisciplinary collaboration. Given our commitment to excellence in radiologic interpretation, we would welcome the opportunity to partner with NIOSH in promoting the B Reader program. Through our extensive network of radiology professionals and educational sessions we can help raise awareness, encourage participation, and ensure that the program continues to uphold the highest standards in detecting and monitoring occupational lung diseases.
Federal occupational health surveillance programs are critical to ensuring the health and well-being of workers across a variety of industries. RSNA strongly encourages NIOSH to uphold the highest standards of radiologic interpretation within the B Reader program while seeking to optimize the utilization of existing certified B Readers through technological innovation and continued engagement with the radiology community. We welcome further discussion of how RSNA might support NIOSH in meeting current challenges and enhancing the B Reader program. For additional information or questions, please contact RSNA's director of government relations, Libby O'Hare (eohare@rsna.org).
Sincerely,
Jeffrey Klein, MD
Chair of the Board
Radiological Society of North America
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Original text here: https://downloads.regulations.gov/CDC-2024-0103-0893/attachment_1.pdf
Bureau of Industry & Security Releases Public Communication From SEMI
By Merly T. Lapig
WASHINGTON, March 27 -- The U.S. Department of Commerce Bureau of Industry and Security has released the following public communication on March 14, 2025, from SEMI.Here are excerpts:
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Re: Comments of SEMI on the Interim Final Rule "Foreign-Produced Direct Product Rule Additions, and Refinements to Controls for Advanced Computing and Semiconductor Manufacturing Items"
Document Number: BIS-2024-0028; RIN 0694-AJ74
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I. Introduction
SEMI members welcome the opportunity to provide the following comments regarding the ongoing efforts by the Bureau of Industry and Security (BIS), U.S. ... Show Full Article WASHINGTON, March 27 -- The U.S. Department of Commerce Bureau of Industry and Security has released the following public communication on March 14, 2025, from SEMI. Here are excerpts: * * * Re: Comments of SEMI on the Interim Final Rule "Foreign-Produced Direct Product Rule Additions, and Refinements to Controls for Advanced Computing and Semiconductor Manufacturing Items" Document Number: BIS-2024-0028; RIN 0694-AJ74 * * * I. Introduction SEMI members welcome the opportunity to provide the following comments regarding the ongoing efforts by the Bureau of Industry and Security (BIS), U.S.Department of the Commerce, to refine and clarify U.S. export control restrictions under the Export Administration Regulations (EAR) on advanced computing and semiconductor manufacturing items.
Founded in 1970, SEMI is the leading global industry association dedicated to advancing the electronics manufacturing supply chain. With more than 3,500 members worldwide--including more than 600 U.S.-headquartered companies--SEMI represents a broad spectrum of the semiconductor industry, including chip designers, equipment manufacturers, materials suppliers, and subcomponent producers. While SEMI's membership includes large multinational corporations, more than 85 percent of its members are small and medium-sized enterprises. Collectively, these companies form the backbone of the $2 trillion global electronics industry, which supports greater than 350,000 high-skill, high-wage jobs in the United States.1
Given their significance in emerging technologies such as AI, quantum computing, and 5G/6G networks, semiconductors represent one of the most complex and interdependent industries in the global economy.
In recent years, BIS has expressed concerns with certain countries of concern pursuing semiconductor self-sufficiency under its Military-Civil Fusion (MCF) strategy, which seeks to integrate civilian technological advancements into military applications. State media in countries of concern have explicitly identified integrated circuits (ICs) as a strategic priority, with the goal of eliminating barriers between commercial and defense sectors. In response, BIS has substantially expanded U.S. export controls in an effort to curb access to advanced-node ICs and semiconductor manufacturing equipment (SME) to...
/1 A full list of SEMI members can be found at https://www.semi.org/en/resources/member-directory. For more information about SEMI, see "About SEMI" https://www.semi.org/en/about-semimembership/about-semi, January 2025.
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...prevent their misuse in military, surveillance, and cyberwarfare applications in countries of concern.
Since October 7, 2022, BIS has implemented an array of complex controls on advanced-node ICs and SME, including by introducing new Export Control Classification Numbers (ECCNs), including 3A090 (high-performance ICs), 4A090 (related computing items), and 3B090 (SME used in advanced-node IC production). These measures impose strict licensing requirements and substantially expanded the Foreign Direct Product (FDP) rules to extend the reach of U.S. export jurisdiction over foreign-made items produced using U.S. technology and destined for certain end-users and end uses in countries of concern.
Most recently, on December 2, 2024, BIS issued another Interim Final Rule (IFR) aimed at further expanding controls on advanced computing and semiconductor manufacturing items. Among other things, this latest rule introduces new FDP rules, revises the definition of "Advanced-Node Integrated Circuit", and implements new controls on high-bandwidth memory (HBM).
This rulemaking is presumably consistent with BIS's statutory authority under the Export Control Reform Act of 2018 (ECRA), which grants BIS the power to regulate exports that could threaten U.S. national security, contribute to Weapons of Mass Destruction (WMD) proliferation, or undermine U.S. foreign policy interests. The IFR intends to effectively restrict access in countries of concern to advanced-node ICs, SME, and computing technologies that could be leveraged for military applications, cyberwarfare, or human rights violations. However, to comply with constitutional due process requirements, BIS must ensure that the regulations are clear and unambiguous.
Finally, this rule is subject to Executive Orders 12866, 13563, and 14094, which direct BIS to assess regulatory costs and benefits, enhance regulatory efficiency, and minimize unnecessary compliance burdens. For the reasons stated below, these regulations have substantial regulatory costs and impose significant and unnecessary compliance burdens.
II. General Comments
A. Standard of Review
BIS has "the responsibility to promulgate clear and unambiguous standards." United States. v. Trident Seafoods Corp., 60 F.3d 556, 559 (9th Cir. 1995) (cleaned up). That is not only a constitutional requirement, the Export Control Reform Act of 2018 makes clear that "[t]he effective administration of export controls requires a clear understanding both inside and outside the United States Government of which items are controlled and an efficient process should be created to regularly update the controls, such as by adding or removing such items." 50 U.S.C. Sec. 4811(7). In short, BIS should "create enforceable regulations," 50 U.S.C. 4825(b)(2), which can be impacted where the regulations are not "clear and unambiguous," Trident Seafoods Corp., 60 F.3d at 559.
B. The Need for Greater Clarity, Consistency, and Industry Engagement in BIS Rulemaking
The semiconductor industry continues to face uncertainty and compliance challenges due to unresolved issues from previous BIS rulemakings. While BIS has taken steps to refine the EAR, ongoing ambiguities, inconsistent guidance, and limited industry engagement have made compliance more complex and weakened the global competitiveness of U.S. firms.
One of the most significant concerns is the lack of consistent and comprehensive guidance following the October 7, 2022, rule and subsequent updates. In the absence of clear interpretative guidance from BIS, these frequent adjustments, expansions, and technical modifications to semiconductor-related export controls have left companies navigating a complex and constantly shifting and ambiguous regulatory environment. This uncertainty increases the risk of over-compliance and inadvertent noncompliance and imposes disproportionate burdens on the semiconductor industry, who must contend with complex licensing determinations while competing against foreign firms that are not subject to similar constraints.
Exacerbating this ambiguity are the FDP rules, which remain a separate, yet significant challenge. The FDP rules broad extraterritorial application has resulted in overbroad restrictions for materials and equipment that arguably do not advance the protection of national security (e.g., legacy materials that are readily available from sources outside of the United States) and other unintended competitive disadvantages for U.S. firms. By extending U.S. jurisdiction over foreign-manufactured products that are the direct products of a growing list of U.S. technology or equipment, the rules have accelerated a trend of "designing out" U.S. technology, as international buyers shift their supply chains away from U.S.-based inputs to avoid regulatory risk. This dynamic undermines long-term U.S. leadership in semiconductor technologies, making it essential for BIS to reevaluate the effectiveness of unilateral controls and prioritize multilateral export control frameworks that prevent supply chain fragmentation and competitive advantage to non-US manufacturers while still addressing national security concerns.
BIS should also improve mechanisms for interacting with industry to ensure that regulatory changes are informed by practical supply chain realities. While BIS has accepted public comments on previous rules, the speed and frequency of the new rules have often outpaced meaningful industry consultation, thereby creating overbroad and often ambiguous restrictions. Among other things, this dynamic results in disparate interpretations of relevant compliance obligations among similarly situated companies. We encourage BIS to develop additional mechanisms to facilitate regular and effective engagement with industry stakeholders in the development of future export controls.
C. Addressing the Unintended Acceleration of Semiconductor Supply Chain Indigenization
A key challenge arising from recent and largely unilateral U.S. export control measures is the unintended acceleration of foreign semiconductor supply chain indigenization, which undermines U.S. strategic leverage in the global industry. While BIS's intent is to restrict access to semiconductor technologies for national security reasons, these restrictions have also incentivized foreign governments and companies to develop domestic alternatives, reducing U.S. influence over global supply chains.
Restricted countries have intensified state-backed investments in semiconductor manufacturing, aiming to eliminate reliance on U.S. and allied technologies. This includes expanding domestic fabrication capacity, increasing self-sufficiency in SME and materials, and accelerating research into critical sub-components, such as lithography, deposition, and etching technologies. Resulting in part from U.S. export restrictions, foreign firms from restricted countries have already made significant progress in closing technological gaps, particularly in legacy-node semiconductor production, advanced packaging, and high-bandwidth memory (HBM) technologies. This shift has allowed states to circumvent U.S. export restrictions by fostering domestically controlled supply chains, thereby reducing the effectiveness of U.S. export controls over time.
Additionally, U.S. export restrictions have created gaps in the global supply chain creating opportunities for foreign firms which didn't exist previously. As foreign competitors step in to supply semiconductor technologies for which they are not restricted, U.S. firms are forced to retreat from global competitiveness putting them at a long-term disadvantage. Without better coordination with allied nations, the U.S. risks self-harm by ceding global market share without achieving meaningful national security gains.
To balance security concerns with economic competitiveness, BIS should reassess the scope of its largely unilateral controls and develop mechanisms-- including by refocusing on multilateral approaches--to mitigate unintended harm to U.S. firms. This could include targeted licensing flexibilities or easing restrictions on legacy-node semiconductor materials and equipment that do not pose immediate national security risks to ensure that that U.S. firms remain competitive on the global market. By refining its multilateral and regulatory approach, BIS can reduce overly complex compliance burdens, encourage continued innovation, and ensure that U.S. companies remain central to global semiconductor supply chains--all while effectively protecting national security interests.
[Text omitted]
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IV. Conclusion
SEMI members appreciate the opportunity to provide feedback on this Interim Final Rule and recognize the importance of protecting U.S. technological leadership and preventing the unauthorized use of advanced semiconductor technologies for military applications.
At the same time, it is essential that these regulations are clear, targeted, and aligned with global industry realities to avoid unintended consequences for U.S. companies operating in the global market. The concerns outlined in this submission aim to strike a balanced approach that ensures national security without unnecessarily hindering U.S.-based industry growth, innovation, or market participation.
SEMI members recognize BIS's consideration of these perspectives and look forward to continued collaboration with the Department to develop regulations that protect national security without unduly hindering the growth and innovation of the semiconductor industry.
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Original text here: https://downloads.regulations.gov/BIS-2024-0028-0008/attachment_1.pdf